Title of Regulation: 1VAC30-45. Certification for Noncommercial Environmental Laboratories (amending 1VAC30-45-10, 1VAC30-45-30 through 1VAC30-45-130, 1VAC30-45-300 through 1VAC30-45-400, 1VAC30-45-500, 1VAC30-45-510, 1VAC30-45-520, 1VAC30-45-600, 1VAC30-45-610, 1VAC30-45-660, 1VAC30-45-670, 1VAC30-45-720 through 1VAC30-45-771, 1VAC30-45-775, 1VAC30-45-791, 1VAC30-45-796, 1VAC30-45-798, 1VAC30-45-811, 1VAC30-45-850; adding 1VAC30-45-95; repealing 1VAC30-45-530, 1VAC30-45-780 through 1VAC30-45-788, 1VAC30-45-800 through 1VAC30-45-808, 1VAC30-45-820 through 1VAC30-45-829).

Statutory Authority: § 2.2-1105 of the Code of Virginia.

Effective Date: September 1, 2016.

Agency Contact: Rhonda Bishton, Regulatory Coordinator, Department of General Services, 1100 Bank Street, Suite 420, Richmond, VA 23219, telephone (804) 786-3311, FAX (804) 371-8305, or email rhonda.bishton@dgs.virginia.gov.

Summary:

The amendments (i) streamline the procedures for application and renewal of certification, (ii) reduce the requirement to perform proficiency test studies to one study annually for each field of certification, (iii) expand the time between on-site assessments from two years to three years for laboratories regularly meeting certification standards, (iv) eliminate requirements for specialized testing that noncommercial laboratories currently do not perform, (v) add procedures for suspension of certification to provide a laboratory time to correct problems to avoid decertification, (vi) make explicit the requirements to notify a laboratory that the agency has cause to deny certification or to decertify, (vii) simplify the appeal procedure language, (viii) restructure and modify the fee system and increase the fees paid by laboratories, and (ix) eliminate, or provide increased flexibility for, a number of quality system provisions (Article 4).

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

Part I
General Provisions

1VAC30-45-10. Purpose.

Section 2.2-1105 of the Code of Virginia directs the Division of Consolidated Laboratory Services to establish a program to certify environmental laboratories that perform tests, analyses, measurements or monitoring required pursuant to the Commonwealth's air, waste and water laws and regulations. This chapter sets out the required standards and the process by which owners of noncommercial environmental laboratories may obtain certification for their laboratories. 1VAC30-46 covers commercial environmental laboratories and NELAP-accredited environmental laboratories seeking reciprocal accreditation in Virginia.

1VAC30-45-30. Applicability.

A. This chapter applies to any owner of a noncommercial environmental laboratory.

B. Any environmental laboratory owned by an agency of the federal government may be certified as follows:

1. By DGS-DCLS DCLS to the standards set out in this chapter; or

2. By a federal primary accrediting authority accreditation body to the standards established by the National Environmental Laboratory Accreditation Conference TNI.

C. Citizen monitoring groups. Section 62.1-44.19:11 of the Code of Virginia both establishes a citizen water quality monitoring program for Virginia and encourages the growth of the program. The Department of Environmental Quality (DEQ) has a separate program of quality assurance and quality control (QA/QC) standards for citizen monitoring groups and their laboratories to follow. The following laboratories shall meet the [ DEG DEQ ] QA/QC requirements developed for the purposes of citizen monitoring of water quality in lieu of the requirements of 1VAC30-45 or 1VAC30-46:

1. Laboratories owned by citizen monitoring groups.

2. Laboratories at institutions of higher education affiliated with citizen monitoring groups for the purposes of analyzing samples for the groups.

D. Environmental research performed by environmental laboratories owned by institutions of higher education. Institutions of higher education. Environmental laboratories owned by institutions of higher education located in Virginia that perform analyses for the purpose of providing environmental research data to DEQ at DEQ's request shall meet the QA/QC requirements specified by DEQ. An environmental laboratory owned by an institution of higher education located in Virginia that performs environmental research for DEQ shall not be subject to the requirements of either 1VAC30-45 or 1VAC30-46 unless DEQ requires the laboratory to do so.

1VAC30-45-40. Definitions.

Where a term is defined in this section, the term shall have no other meaning, even if it is defined differently in the Code of Virginia or another regulation of the Virginia Administrative Code. Unless specifically defined in this section, the terms used in this chapter shall have the meanings commonly ascribed to them by recognized authorities. The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise.

"Acceptance criteria" means specified limits placed on characteristics of an item, process, or service defined in requirement documents.

"Accuracy" means the degree of agreement between an observed value and an accepted reference value. Accuracy includes a combination of random error (precision) and systematic error (bias) components that are due to sampling and analytical operations. Accuracy is an indicator of data quality.

"Algae" means simple single-celled, colonial, or multicelled, mostly aquatic plants, containing chlorophyll and lacking roots, stems and leaves that are either suspended in water (phytoplankton) or attached to rocks and other substrates (periphyton).

"Aliquot" means a portion of a sample taken for analysis.

"Analyte" means the substance or physical property to be determined in samples examined.

"Analytical method" means a technical procedure for providing analysis of a sample, defined by a body such as the Environmental Protection Agency or the American Society for Testing and Materials, that may not include the sample preparation method.

"Assessment" means the evaluation process used to measure or establish the performance, effectiveness, and conformance of an organization and its systems or both to defined criteria.

"Assessor" means the person who performs on-site assessments of laboratories' capability and capacity for meeting the requirements under this chapter by examining the records and other physical evidence for each one of the tests for which certification has been requested assigned by DCLS to perform, alone or as part of an assessment team, an assessment of an environmental laboratory.

"Audit" means a systematic evaluation to determine the conformance to quantitative and qualitative specifications of some operational function or activity.

"Authority" means, in the context of a governmental body or local government, an authority created under the provisions of the Virginia Water and Waste Authorities Act, Chapter 51 (§ 15.2-5100 et seq.) of Title 15.2 of the Code of Virginia.

"Batch" means environmental samples that are prepared together or analyzed together or both with the same process and personnel, using the same lot or lots of reagents. "Analytical batch" means a batch composed of prepared environmental samples (extracts, digestates or concentrates) that are analyzed together as a group. An analytical batch can include prepared samples originating from various environmental matrices and can exceed 20 samples. "Preparation batch" means a batch composed of one to 20 environmental samples of the same matrix that meets the criteria in this definition for "batch" and with a maximum time between the start of processing of the first and last sample in the batch to be 24 hours.

"Benthic macroinvertebrates" means bottom dwelling animals without backbones that live at least part of their life cycles within or upon available substrates within a body of water.

"Blank" means a sample that has not been exposed to the analyzed sample stream in order to monitor contamination during sampling, transport, storage or analysis. The blank is subjected to the usual analytical and measurement process to establish a zero baseline or background value and is sometimes used to adjust or correct routine analytical results. Blanks include the following types:

1. Field blank. A blank prepared in the field by filling a clean container with pure deionized water and appropriate preservative, if any, for the specific sampling activity being undertaken.

2. Method blank. A sample of a matrix similar to the batch of associated samples (when available) that is free from the analytes of interest and is processed simultaneously with and under the same conditions as samples through all steps of the analytical procedures, and in which no target analytes or interferences are present at concentrations that impact the analytical results for sample analyses.

"Calibration" means to determine, by measurement or comparison with a standard, the correct value of each scale reading on a meter, instrument or other device. The levels of the applied calibration standard should bracket the range of planned or expected sample measurements.

"Calibration curve" means the graphical relationship between the known values, such as concentrations, of a series of calibration standards and their instrument response.

"Calibration standard" means a substance or reference material used to calibrate an instrument.

"Certified reference material" means a reference material one or more of whose property values are certified by a technically valid procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body.

"Client" or "customer" means the Department of Environmental Quality (DEQ) when used in the context of quality assurance and specific quality control provisions.

"Commercial environmental laboratory" means an environmental laboratory where environmental analysis is performed for another person.

"Corrective action" means the action taken to eliminate the causes of an existing nonconformity, defect or other undesirable situation in order to prevent recurrence.

"DGS-DCLS" "DCLS" means the Division of Consolidated Laboratory Services of the Department of General Services.

"Demonstration of capability" means the procedure to establish the ability of the analyst to generate data of acceptable accuracy and precision.

"Detection limit" means the lowest concentration or amount of the target analyte that can be determined to be different from zero by a single measurement at a stated degree of confidence.

"Environmental analysis" or "environmental analyses" means any test, analysis, measurement, or monitoring used for the purposes of the Virginia Air Pollution Control Law, the Virginia Waste Management Act or the State Water Control Law (§ 10.1-1300 et seq., § 10.1-1400 et seq., and § 62.1-44.2 et seq., respectively, of the Code of Virginia). For the purposes of these regulations, any test, analysis, measurement, or monitoring required pursuant to the regulations promulgated under these three laws, or by any permit or order issued under the authority of any of these laws or regulations is "used for the purposes" of these laws. The term shall not include the following:

1. Sampling of water, solid and chemical materials, biological tissue, or air and emissions.

2. Field testing and measurement of water, solid and chemical materials, biological tissue, or air and emissions, except when performed in an environmental laboratory rather than at the site where the sample was taken.

3. Taxonomic identification of samples for which there is no national accreditation standard such as algae, benthic macroinvertebrates, macrophytes, vertebrates and zooplankton.

4. Protocols used pursuant to § 10.1-104.2 of the Code of Virginia to determine soil fertility, animal manure nutrient content, or plant tissue nutrient uptake for the purposes of nutrient management.

5. Geochemical and permeability testing for solid waste compliance.

6. Materials specification for air quality compliance when product certifications specify the data required by an air permit such as fuel type, Btu content, sulfur content, or VOC content.

"Environmental laboratory" or "laboratory" means a facility or a defined area within a facility where environmental analysis is performed. A structure built solely to shelter field personnel and equipment from inclement weather shall not be considered an environmental laboratory.

"Establishment date" means the date set for the accreditation program under 1VAC30-46 and the certification program to be established under this chapter.

"Establishment of certification program" or "established program" means that DGS-DCLS DCLS has completed the initial accreditation of environmental laboratories covered by 1VAC30-46 and the initial certification of environmental laboratories covered by 1VAC30-45.

"Facility" means something that is built or installed to serve a particular function.

"Field of certification" or "FoC" means an approach to certifying laboratories by those matrix, technology/method, and analyte/analyte group analyte combinations for which DCLS offers certification.

"Field of proficiency testing" or "FoPT" means analytes for which a laboratory is required to successfully analyze a PT sample in order to obtain or maintain certification, collectively defined as matrix, technology/method, and analyte.

"Field testing and measurement" means any of the following:

1. Any test for parameters under 40 CFR Part 136 for which the holding time indicated for the sample requires immediate analysis; or

2. Any test defined as a field test in federal regulation.

The following is a limited list of currently recognized field tests or measures that is not intended to be inclusive: continuous emissions monitoring; on-line online monitoring; flow monitoring; tests for pH, residual chlorine, temperature and dissolved oxygen; and field analysis for soil gas.

"Finding" means an assessment conclusion that identifies a condition having a significant effect on an item or activity. An assessment finding is normally a deficiency and is normally accompanied by specific examples of the observed condition. referenced to a laboratory certification standard and supported by objective evidence that identifies a deviation from a laboratory certification standard requirement.

"Governmental body" means any department, agency, bureau, authority, or district of the United States government, of the government of the Commonwealth of Virginia, or of any local government within the Commonwealth of Virginia.

"Holding time (or maximum allowable holding time)" means the maximum time that a sample may be held prior to analysis and still be considered valid or not compromised can elapse between two specified activities.

"Initial certification period" means the period during which DGS-DCLS is accepting and processing applications for the first time under this chapter as specified in 1VAC30-45-60.

"International System of Units (SI)" means the coherent system of units adopted and recommended by the General Conference on Weights and Measures.

"Laboratory control sample" or "LCS" means a sample matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material containing known and verified amounts of analytes. It is generally used to establish intra-laboratory or analyst specific precision and bias or to assess the performance of all or a portion of the measurement system. "Laboratory control sample" or "LCS" may also be named laboratory fortified blank, spiked blank, or QC check sample.

"Laboratory manager" means the person who has overall responsibility for the technical operation of the environmental laboratory and who exercises actual day-to-day supervision of laboratory operation for the appropriate fields of testing and reporting of results. The title of this person may include but is not limited to laboratory director, technical director, laboratory supervisor or laboratory manager.

"Legal entity" means an entity, other than a natural person, who has sufficient existence in legal contemplation that it can function legally, be sued or sue, and make decisions through agents as in the case of corporations.

"Limit of detection" or "LOD" means an estimate of the minimum amount of a substance that an analytical process can reliably detect. An LOD is analyte and matrix specific and may be laboratory dependent.

"Limit of quantitation" or "LOQ" means the minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of confidence.

"Local government" means a municipality (city or town), county, sanitation district, or authority.

"Macrophytes" means any aquatic or terrestrial plant species that can be identified and observed with the eye, unaided by magnification.

"Matrix" means the component or substrate that may contain the analyte of interest. A matrix can be a field of certification matrix or a quality system matrix.

1. Field of certification matrix. These matrix definitions shall be used when certifying a laboratory.

a. Non-potable Nonpotable water. Any aqueous sample that has not been designated a potable or potential potable water source. Includes surface water, groundwater, effluents, water treatment chemicals, and TCLP or other extracts.

b. Solid and chemical materials. Includes soils, sediments, sludges, products and byproducts of an industrial process that results in a matrix not previously defined.

c. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

d. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

2. Quality system matrix. For purposes of batch and quality control requirement determinations, the following matrix types shall be used:

a. Drinking water. Any aqueous sample that has been designated a potable or potential potable water source.

b. Aqueous. Any aqueous sample excluded from the definition of drinking water matrix or saline/estuarine source. Includes surface water, groundwater, effluents, and TCLP or other extracts.

c. Saline/estuarine. Any aqueous sample from an ocean or estuary, or other salt water source.

d. Nonaqueous liquid. Any organic liquid with less than 15% settleable solids.

e. Biological tissue. Any sample of a biological origin such as fish tissue, shellfish, or plant material. Such samples shall be grouped according to origin.

f. Solids. Includes soils, sediments, sludges and other matrices with more than 15% settleable solids.

g. Chemical waste. A product or by-product byproduct of an industrial process that results in a matrix not previously defined.

h. Air and emissions. Whole gas or vapor samples including those contained in flexible or rigid wall containers and the extracted concentrated analytes of interest from a gas or vapor that are collected with a sorbent tube, impinger solution, filter or other device.

"Matrix spike (spiked sample or fortified sample)" means a sample prepared by adding a known mass of target analyte to a specified amount of matrix sample for which an independent estimate of target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the matrix on a method's recovery efficiency.

"Matrix spike duplicate (spiked sample or fortified sample duplicate)" means a second replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each analyte.

"National Environmental Laboratory Accreditation Conference (NELAC)" means a voluntary organization of state and federal environmental officials and interest groups with the primary purpose to establish mutually acceptable standards for accrediting environmental laboratories. A subset of NELAP.

"National Environmental Laboratory Accreditation Program (NELAP)" means the overall National Environmental Laboratory Accreditation Program of which NELAC is a part.

"National Institute of Standards and Technology" or "NIST" means an agency of the U.S. Department of Commerce's Technology Administration that is working with EPA, states, NELAC, and other public and commercial entities to establish a system under which private sector companies and interested states can be certified by NIST to provide NIST-traceable proficiency testing (PT) samples.

"Negative control" means measures taken to ensure that a test, its components, or the environment do not cause undesired effects, or produce incorrect test results.

"Noncommercial environmental laboratory" means either of the following:

1. An environmental laboratory where environmental analysis is performed solely for the owner of the laboratory.

2. An environmental laboratory where the only performance of environmental analysis for another person is one of the following:

a. Environmental analysis performed by an environmental laboratory owned by a local government for an owner of a small wastewater treatment system treating domestic sewage at a flow rate of less than or equal to 1,000 gallons per day.

b. Environmental analysis performed by an environmental laboratory operated by a corporation as part of a general contract issued by a local government to operate and maintain a wastewater treatment system or a waterworks.

c. Environmental analysis performed by an environmental laboratory owned by a corporation as part of the prequalification process or to confirm the identity or characteristics of material supplied by a potential or existing customer or generator as required by a hazardous waste management permit under 9VAC20-60.

d. Environmental analysis performed by an environmental laboratory owned by a Publicly Owned Treatment Works (POTW) for an industrial source of wastewater under a permit issued by the POTW to the industrial source as part of the requirements of a pretreatment program under Part VII (9VAC25-31-730 et seq.) of 9VAC25-31.

e. Environmental analysis performed by an environmental laboratory owned by a county authority for any municipality within the county's geographic jurisdiction when the environmental analysis pertains solely to the purpose for which the authority was created.

f. Environmental analysis performed by an environmental laboratory owned by an authority or a sanitation district for any participating local government of the authority or sanitation district when the environmental analysis pertains solely to the purpose for which the authority or sanitation district was created.

"Owner" means any person who owns, operates, leases or controls an environmental laboratory.

"Person" means an individual, corporation, partnership, association, company, business, trust, joint venture or other legal entity.

"Physical," for the purposes of fee test categories, means the tests to determine the physical properties of a sample. Tests for solids, turbidity and color are examples of physical tests.

"Positive control" means measures taken to ensure that a test or its components are working properly and producing correct or expected results from positive test subjects.

"Precision" means the degree to which a set of observations or measurements of the same property, obtained under similar conditions, conform to themselves. Precision is an indicator of data quality. Precision is expressed usually as standard deviation, variance or range, in either absolute or relative terms.

"Primary accrediting authority accreditation body" means the agency or department designated at the territory, state or federal level as the recognized authority with the responsibility and accountability for granting NELAC accreditation to a specific laboratory for a specific field of accreditation body responsible for assessing a laboratory's total quality system, on-site assessment, and PT performance tracking for fields of accreditation.

"Proficiency test or testing (PT)" means evaluating a laboratory's performance under controlled conditions relative to a given set of criteria through analysis of unknown samples provided by an external source.

"Proficiency test (PT) field of testing" means the approach to offer proficiency testing by maxtrix, technology/method, and analyte/analyte group.

"Proficiency test (PT) sample" means a sample, the composition of which is unknown to both the analyst and the laboratory and is provided to test whether the analyst or laboratory or both laboratory can produce analytical results within specified acceptance criteria.

"Proficiency testing (PT) program" means the aggregate of providing rigorously controlled and standardized environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results and the collective demographics and results summary of all participating laboratories.

"Program," in the context of a regulatory program, means the relevant U.S. Environmental Protection Agency program such as the water program under the Clean Water Act (CWA), the air program under the Clean Air Act (CAA), the waste program under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund) or the waste program under the Resource Conservation and Recovery Act (RCRA).

"Publicly Owned Treatment Works (POTW)" means a treatment works as defined by § 212 of the CWA, which is owned by a state or municipality (as defined by § 502(4) of the CWA). This definition includes any devices and systems used in the storage, treatment, recycling, and reclamation of municipal sewage or industrial wastes of a liquid nature. It also includes sewers, pipes, and other conveyances only if they convey wastewater to a POTW treatment plant. The term also means the municipality as defined in § 502(4) of the CWA, which has jurisdiction over the indirect discharges to and the discharges from such a treatment works.

"Quality assurance" or "QA" means an integrated system of management activities involving planning, quality control, quality implementation, assessment, reporting and quality improvement to ensure that a product process, item, or service meets defined standards of quality with a stated level of confidence is of the type and quality needed and expected by the client.

"Quality assurance officer" means the person who has responsibility for the quality system and its implementation. Where staffing is limited, the quality assurance officer may also be the laboratory manager.

"Quality control" or "QC" means the overall system of technical activities whose purpose is to measure and control the quality of a product or service so that it meets the needs of users that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the customer; operational techniques and activities that are used to fulfill requirements for quality; and also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.

"Quality manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to ensure the quality of its product and the utility of its product to its users.

"Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework for planning, implementing, and assessing work performed by the organization and for carrying out required quality assurance and quality control activities.

"Range" means the difference between the minimum and maximum of a set of values.

"Reference material" means a material or substance one or more properties of which are sufficiently well established to be used for the calibration of an apparatus, the assessment of a measurement test method, or for assigning values to materials.

"Reference standard" means a standard, generally of the highest metrological quality available at a given location, from which measurements made at that location are derived.

"Responsible official" means one of the following, as appropriate:

1. If the laboratory is owned or operated by a private corporation, "responsible official" means (i) a president, secretary, treasurer, or a vice-president of the corporation in charge of a principal business function, or any other person who performs similar policy-making or decision-making functions for the corporation or (ii) the manager of one or more manufacturing, production, or operating facilities employing more than 250 persons or having gross annual sales or expenditures exceeding $25 million (in second-quarter 1980 dollars), if authority to sign documents has been assigned or delegated in accordance with corporate procedures.

2. If the laboratory is owned or operated by a partnership, association, or a sole proprietor, "responsible official" means a general partner, officer of the association, or the proprietor, respectively.

3. If the laboratory is owned or operated by a governmental body, "responsible official" means a director or highest official appointed or designated to oversee the operation and performance of the activities of the environmental laboratory.

4. Any person designated as the responsible official by an individual described in subdivision 1, 2 or 3 of this definition, provided the designation is in writing, the designation specifies an individual or position with responsibility for the overall operation of the environmental laboratory, and the designation is submitted to DGS-DCLS DCLS.

"Sampling" means the act of collection for the purpose of analysis.

"Sanitation district" means a sanitation district created under the provisions of Chapters 3 (§ 21-141 et seq.) through 5 (§ 21-291 et seq.) of Title 21 of the Code of Virginia.

"Sewage" means the water-carried human wastes from residences, buildings, industrial establishments or other places together with such industrial wastes and underground, surface, storm, or other water as may be present.

"Simple test procedures" or "STP" means any of the following:

1. Field testing and measurement performed in an environmental laboratory.

2. The test procedures to determine:

a. Biochemical oxygen demand (BOD) or carbonaceous BOD (CBOD);

b. Fecal coliform;

c. Total coliform;

d. Fecal streptococci;

e. E. coli;

f. Enterococci;

g. Settleable solids (SS);

h. Total dissolved solids (TDS);

i. Total solids (TS);

j. Total suspended solids (TSS);

k. Total volatile solids (TVS); and

l. Total volatile suspended solids (TVSS).

"Standard operating procedure (SOP)" or "SOP" means a written document that details the method of an operation, analysis or action whose techniques and procedures are thoroughly prescribed and which is accepted for an operation, analysis, or action with thoroughly prescribed techniques and steps. An SOP is officially approved as the method for performing certain routine or repetitive tasks.

"Standardized reference material (SRM)" or "SRM" means a certified reference material produced by the U.S. National Institute of Standards and Technology or other equivalent organization and characterized for absolute content, independent of analytical method.

"System laboratory" means a noncommercial laboratory that analyzes samples from multiple facilities having the same owner.

"TCLP" or "toxicity characteristic leachate procedure" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Test" means a technical operation that consists of the determination of one or more characteristics or performance of a given product, material, equipment, organism, physical phenomenon, process or service according to a specified procedure.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Air Pollution Control Law" means any method of analysis required by the Virginia Air Pollution Control Law (§ 10.1-1300 et seq.); by the regulations promulgated under this law (9VAC5) including any method of analysis listed either in the definition of "reference method" in 9VAC5-10-20, or listed or adopted by reference in 9VAC5; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Waste Management Act" means any method of analysis required by the Virginia Waste Management Act (§ 10.1-1400 et seq.); by the regulations promulgated under this law (9VAC20), including any method of analysis listed or adopted by reference in 9VAC20; or by any permit or order issued under and in accordance with this law and these regulations.

"Test, analysis, measurement or monitoring required pursuant to the Virginia Water Control Law" means any method of analysis required by the Virginia Water Control Law (§ 62.1-44.2 et seq.); by the regulations promulgated under this law (9VAC25), including any method of analysis listed or adopted by reference in 9VAC25; or by any permit or order issued under and in accordance with this law and these regulations.

"Test method" means an adoption of a scientific technique for performing a specific measurement as documented in a laboratory standard operating procedure or as published by a recognized authority.

"The NELAC Institute" or "TNI" means the organization whose standards environmental laboratories must meet to become accredited under 1VAC30-46, the regulation governing commercial environmental laboratories in Virginia.

"Toxicity characteristic leachate procedure" or "TCLP" means Test Method 1311 in "Test Methods for Evaluating Solid Waste, Physical/Chemical Methods," EPA Publication SW-846, as incorporated by reference in 40 CFR 260.11. This method is used to determine whether a solid waste exhibits the characteristic of toxicity (see 40 CFR 261.24).

"Traceability" means the property of a result of a measurement whereby it can be related to appropriate standards, generally international or national standards, through an unbroken chain of comparisons.

"U.S. Environmental Protection Agency" or "EPA" means the federal government agency with responsibility for protecting, safeguarding and improving the natural environment (i.e., air, water and land) upon which human life depends.

"Virginia Air Pollution Control Law" means Chapter 13 (§ 10.1-1300 et seq.) of Title 10.1 of the Code of Virginia, which is titled "Air Pollution Control Board."

"Virginia Environmental Laboratory Accreditation Program" or "VELAP" means the program DCLS operates to certify environmental laboratories under this chapter.

"Wastewater" means liquid and water-carried industrial wastes and domestic sewage from residential dwellings, commercial buildings, industrial and manufacturing facilities and institutions.

"Waterworks" means each system of structures and appliances used in connection with the collection, storage, purification, and treatment of water for drinking or domestic use and the distribution thereof to the public, except distribution piping.

"Zooplankton" means microscopic animals that float freely with voluntary movement in a body of water.

1VAC30-45-50. Scope of certification.

A. Noncommercial environmental laboratories shall be certified based on the general laboratory standards set out in Part II (1VAC30-45-200 et seq.) of this chapter and on the specific test methods or analysis, monitoring or measurement required by regulatory permit or other requirement under the Virginia Air Pollution Control Law, Virginia Waste Management Act, or Virginia Water Control Law, the regulations promulgated under these laws, and by permits and orders issued under and in accordance with these laws or regulations.

B. DGS-DCLS DCLS shall review alternative test methods and procedures for certification when these are proposed by the applicant laboratory. The provisions of 1VAC30-45-70 E and 1VAC30-45-90 B govern alternative test methods and procedures.

C. Certification shall be granted for one or more fields of certification, including the matrix, the technology and methods used by the noncommercial environmental laboratory, and the individual analytes or analyte groups determined by the particular method used by the laboratory.

1VAC30-45-60. General: certification requirements.

A. Components of certification. The components of certification include review of personnel qualifications, on-site assessment, proficiency testing, and quality systems. The criteria for these components, set out in Part II (1VAC30-45-200 et seq.) of this chapter, shall be fulfilled for certification.

B. Individual laboratory sites and mobile laboratories.

1. Individual laboratory sites are subject to the same application process, assessments, and other requirements as environmental laboratories. Any remote laboratory sites are considered separate sites and subject to separate on-site assessments.

2. Laboratories located at the same physical location shall be considered an individual laboratory site if these laboratories are owned by the same person, and have the same laboratory manager and quality system.

3. Laboratories located at separate, noncontiguous physical locations may request to be considered as an individual laboratory site if these laboratories are owned by the same person and have the same laboratory manager and quality system.

4. 3. A mobile laboratory, which is configured with equipment to perform analyses, whether associated with a fixed-based laboratory or not, is considered an environmental laboratory and shall require separate certification. This certification shall remain with the mobile laboratory and be site independent. Moving the configured mobile laboratory to a different site will not require a new or separate certification. Before performing analyses at each new site, the laboratory shall ensure that instruments and equipment have been checked for performance and have been calibrated.

1VAC30-45-70. Process to apply and obtain certification.

A. Duty to apply. All owners of noncommercial environmental laboratories shall apply for certification as specified by the provisions of this section. Applications for certification must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Timely initial applications.

1. Owners of noncommercial environmental laboratories applying for certification under this chapter for the first time shall submit an application to DGS-DCLS no later than September 29, 2009.

2. Owners of noncommercial environmental laboratories that come into existence after January 1, 2009, shall submit an initial application to DGS-DCLS no later than 180 calendar days prior to beginning operation.

C. Timely renewal applications. The owner of a certified noncommercial environmental laboratory shall submit an application for renewal of certification at least 90 calendar days prior to expiration of certification.

B. Owners of noncommercial environmental laboratories applying for certification under this chapter for the first time shall submit an application to DCLS as specified under subsection F of this section.

C. Renewal and reassessment.

1. DCLS shall renew certification annually for the certified laboratory provided the laboratory does the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the certificate of compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

d. Pays the fee required by 1VAC30-45-130.

2. DCLS shall reassess the certified environmental laboratory during an on-site assessment as required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

D. Responsibilities of the owner and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for certification.

3. While DGS-DCLS DCLS may notify noncommercial environmental laboratories of the date their applications are due, failure of DGS-DCLS DCLS to notify does not relieve the owner of his obligation to apply under this chapter.

E. Submission of applications for modifications to certification. An owner of a certified noncommercial environmental laboratory shall follow the process set out in 1VAC30-45-90 B to add a new matrix, technology/method, an analyte or analyte group, modify a test method or institute use of a method or technology not in the laboratory's standard operating procedures, including alternative test methods or procedures to modify the laboratory's scope of certification.

F. Contents of application.

1. Applications shall include but not be limited to the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number and e-mail email, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number and e-mail email, as applicable, of laboratory manager;

i. Name, address, telephone number, facsimile number and e-mail email, as applicable, of designated quality assurance officer;

j. Name title, and telephone number of laboratory contact person;

k. Laboratory type (e.g., public water system, public wastewater system or combination of the two, or industrial (with type of industry indicated));

l. Laboratory hours of operation;

m. Fields of certification (matrix, technology/method, and analyte/analyte group) analyte) for which certification is sought;

n. Methods employed, including analytes;

o. n. The results of the three most recent proficiency test studies one successful unique PT study for each field of proficiency testing as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter;

p. o. Quality assurance manual; and

q. Lab identification number (for renewal only); and

r. p. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN#), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-45-130.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by the responsible official, by the quality control officer and by the laboratory manager.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory certification program regulation (1VAC30, Chapter 45) and is subject to the provisions of 1VAC30-45-100 in the event of noncompliance. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial of certification or decertification. I hereby further certify that I am authorized to sign this application."

G. Completeness determination.

1. DGS-DCLS DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. During the initial certification period, DGS-DCLS DCLS shall provide this notice within 90 calendar days of its receipt of a laboratory's initial application. Following the initial certification period, DGS-DCLS shall provide this notice within 60 calendar days of DGS-DCLS's receipt of a laboratory's initial application and within 30 calendar days of DGS-DCLS' receipt of a laboratory's renewal application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DGS-DCLS DCLS from requesting or accepting additional information.

3. If DGS-DCLS DCLS determines that an application is incomplete, DGS-DCLS's the DCLS notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. Except during the initial certification period, if If DCLS makes no determination is made within 60 within 90 calendar days of DGS-DCLS's its receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete. During the initial certification period, the time period shall be 90 calendar days.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DGS-DCLS DCLS requesting additional information, DGS-DCLS DCLS may return the incomplete application and inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim certification pending final determination on application.

1. DGS-DCLS DCLS shall grant a laboratory interim certification status under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for certification, including all requests for additional information, with the exception of on-site assessment; and

c. DGS-DCLS DCLS is unable to schedule the on-site assessment within 90 120 days of its determination that the application is complete (for initial applications) or before the laboratory's certification expires (for renewal applications).

2. A laboratory with interim certification status shall have the same rights and status as a laboratory that has been granted certification by DGS-DCLS DCLS.

3. Interim certification expires when DGS-DCLS DCLS issues a final determination on certification.

I. On-site assessment. 1. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter prior to issuance of a final determination on certification.

2. Alternative on-site assessment option. If DGS-DCLS is unable to schedule an on-site assessment under the conditions of subsection H 1 c of this section, the owner of the applicant laboratory may use third-party on-site assessors instead of DGS-DCLS on-site assessors under the following conditions:

a. The third-party on-site assessors are on a DGS-DCLS-approved list of on-site assessors; and

b. The owner of the applicant laboratory agrees to pay the third-party on-site assessors.

J. Final determination on certification. 1. Upon completion of the certification review process and corrective action, if any, DGS-DCLS DCLS shall grant certification in accordance with subsection K of this section or deny certification in accordance with subsection L of this section.

2. Except during the initial certification period, DGS-DCLS shall complete action on a laboratory's application within nine months from the time a completed application is received from the laboratory.

K. Grant of certification.

1. When a laboratory meets the requirements specified for receiving certification, DGS-DCLS DCLS shall issue a certificate to the laboratory. The DCLS shall send the certificate shall be sent to the laboratory manager, and shall notify the responsible official shall be notified.

2. The director of DGS-DCLS DCLS or his designee shall sign the certificate. The certificate shall include the following information:

a. Name of owner of laboratory;

b. Name of operator of laboratory, if different from owner;

c. Name of responsible official;

d. Address and location of laboratory;

e. Laboratory identification number;

f. Fields of certification (matrix, technology/method, analyte/analyte group) and analyte) for which certification is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

3. The laboratory shall post the most recent certificate of certification and any addenda to the certificate issued by DGS-DCLS DCLS in a prominent place in the laboratory facility.

4. Certification shall expire two years one year after the date on which certification is granted.

L. Denial of certification.

1. DGS-DCLS DCLS shall deny certification to an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

2. Denial of certification in total or in part.

a. DGS-DCLS DCLS may deny certification to an environmental laboratory in total or in part if the laboratory fails to do any of the following:

(1) Pay the required fees.

(2) Employ laboratory staff to meet the personnel qualifications as required by Part II (1VAC30-45-200 et seq.) of this chapter.

(3) Successfully analyze and report proficiency testing samples as required by Part II of this chapter.

(4) Submit a corrective action report plan in accordance with Part II of this chapter in response to a deficiency report from the on-site assessment team within the required 30 calendar days.

(5) Implement the corrective actions detailed in the corrective action report plan within the [ time frame timeframe ] specified by DGS-DCLS DCLS.

(6) Pass required on-site assessment as specified in Part II of this chapter.

(7) Implement a quality system as defined in Part II of this chapter.

b. DGS-DCLS DCLS may deny certification to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 calendar days following notification of incompleteness because the laboratory is delinquent in submitting information required by DGS-DCLS DCLS in accordance with this chapter.

c. DGS-DCLS DCLS may deny certification to an environmental laboratory in total or in part if the DGS-DCLS DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in its application.

3. DGS-DCLS DCLS shall follow the process specified in 1VAC30-45-110 when denying certification to an environmental laboratory.

M. Reapplication following denial of certification. 1. Upon denial of certification, the laboratory shall wait six months before reapplying for certification. 2. DGS-DCLS DCLS shall not waive application fees for a laboratory reapplying for certification.

1VAC30-45-80. Maintaining certification.

A. Certification remains in effect until withdrawn by DGS-DCLS DCLS, withdrawn voluntarily at the written request of the certified laboratory, or until expiration of the certification period. To maintain certification, the certified laboratory shall comply with the elements listed in this section and in 1VAC30-45-90.

B. Quality systems. Laboratories seeking to maintain certification under this chapter shall assure consistency and promote the use of quality assurance and quality control procedures. Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter specifies the quality assurance and quality control requirements that shall be met to maintain certification.

C. Proficiency tests. Laboratories seeking to maintain certification under this chapter shall perform proficiency tests as required under Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

D. Recordkeeping and retention. All laboratory records associated with certification parameters shall be kept as provided by the requirements for records under Part II (1VAC30-45-200 et seq.) of this chapter. These records shall be maintained for a minimum of three years unless the records are required to be maintained for a longer period by another section of this regulation or another regulation. All such records shall be available to DGS-DCLS DCLS upon request.

1VAC30-45-90. Notifications and changes to certification elements and status.

A. Changes to key certification criteria. The certified laboratory shall notify DGS-DCLS DCLS in writing of any changes in key certification criteria within 30 calendar days of the change. Key certification criteria are laboratory ownership, location, key personnel, and major instrumentation.

B. Changes to scope of certification.

1. DGS-DCLS DCLS may approve a laboratory's application to add a new matrix, technology, analyte, or test method to a laboratory's scope of certification or to otherwise modify the laboratory's scope of certification by performing a data review.

2. To apply, the owner of the certified laboratory shall submit the following to DGS-DCLS DCLS:

a. A letter written request signed by the owner that briefly summarizes the addition to be made to the laboratory's scope of certification.

b. Pertinent information demonstrating the laboratory's capability to perform the additional matrix, technology/method, or analyte/analyte group analyte, such as proficiency testing performance and quality control performance.

c. A written standard operating procedure covering the new matrix, technology/method, or analyte/analyte group analyte.

3. DGS-DCLS DCLS may approve a laboratory's application for modification to its scope of certification by performing a review of the application materials submitted, without an on-site assessment. The addition of a technology or test method requiring the use of specific equipment may require an on-site assessment. Other reviews of performance and documentation may be carried out by DGS-DCLS DCLS depending on the modification for which the laboratory applies.

4. Within 90 calendar days of the receipt of the application from the certified environmental laboratory, DGS-DCLS DCLS shall review and determine whether the proposed modification may be approved.

5. If the proposed modification to the laboratory's scope of certification is approved, DGS-DCLS DCLS shall amend the laboratory's certificate of certification.

6. DCLS shall not send the amended certificate of certification to the laboratory until DCLS receives the payment of the fee required under 1VAC30-45-130 F 1.

C. Change of ownership or location of laboratory.

1. The certified laboratory shall submit a written notification to DGS-DCLS DCLS of the change of ownership or location of the laboratory within 30 calendar days of the change. This requirement applies only to fixed-based and not pertaining to change of location does not apply to mobile laboratories.

2. Certification may be transferred when the legal status or ownership of a certified laboratory changes as long as the transfer does not affect the laboratory's personnel, equipment, or organization.

3. If the laboratory's personnel, equipment, or organization are affected by the change of legal status or ownership, DGS-DCLS DCLS may require recertification or reapplication in any or all of the categories for which the laboratory is certified.

4. DGS-DCLS DCLS may require an on-site assessment depending on the nature of the change of legal status or ownership. DGS-DCLS DCLS shall determine the elements of any on-site assessment required.

5. When there is a change in ownership, the new owner of the certified laboratory shall assure historical traceability of the laboratory identification numbers.

6. 5. When there is a change in ownership, the new owner of the certified laboratory shall keep all records and analyses performed by the previous owner under his scope of pertaining to certification for a period of three years, or longer if required by other regulations. These records and analyses are subject to inspection by DGS-DCLS DCLS during this three-year period. This provision applies regardless of change of ownership, accountability or liability.

D. Voluntary withdrawal. Any environmental laboratory owner who wishes to withdraw the laboratory from its certification status or from being certified, in total or in part, shall submit written notification to DGS-DCLS no later than 30 calendar days before the end of the laboratory's certification term DCLS. Within 30 calendar days, DGS-DCLS DCLS shall provide the laboratory with a written notice of withdrawal.

1VAC30-45-95. Suspension of certification.

A. DCLS may suspend certification from an environmental laboratory in total or in part to allow the laboratory time to correct the reason for which DCLS may withdraw certification. Suspension is limited to the reasons listed in subsection B of this section.

B. DCLS may suspend certification from an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Satisfactorily complete proficiency testing studies as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

3. Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

4. Employ staff that meets the personnel qualifications of Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

5. Notify DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

C. Process to suspend certification.

1. When DCLS becomes aware of a cause to suspend a laboratory, the agency shall send notification to the responsible official and the laboratory manager stating it appears to DCLS that the laboratory has failed to meet the 1VAC30-45 standards for one or more of the reasons listed in subsection B of this section. DCLS shall send the notification by certified mail.

2. The DCLS notification shall do the following:

a. Require the laboratory to provide DCLS with documentation of the corrective action already taken with regard to its failure to meet a standard under subsection B of this section.

b. State the corrective action the laboratory must take and the time allowed for this corrective action to be completed in order to retain certification.

3. The environmental laboratory may proceed to correct the deficiencies for which DCLS may suspend the laboratory's certification.

4. Alternatively the laboratory may state in writing that DCLS is incorrect in its observations regarding potential suspension and give specific reasons why the laboratory believes DCLS should not suspend certification. The laboratory has the right to due process as set forth in 1VAC30-45-110, the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia), and Part 2A of the Rules of the Supreme Court of Virginia.

5. With the exception of subdivision B 4 of this section, DCLS may allow the laboratory up to 60 days to correct the problem for which it may have its certification suspended.

6. DCLS shall set a date for suspension that follows the period provided under subdivision 5 of this subsection to restore certification.

7. If the laboratory does not correct its deficiencies within the time period allowed or pursue options under subdivision 4 of this subsection, DCLS may suspend a laboratory in part or in total.

8. DCLS shall notify the laboratory by letter if the laboratory's certification is suspended in part or in total. DCLS shall send the notification by certified mail. DCLS shall also notify the pertinent Virginia state agency of the laboratory's suspension status.

9. The laboratory may provide information demonstrating why suspension is not warranted in accordance with subdivision 4 of this subsection.

D. Responsibilities of the environmental laboratory and DCLS when certification has been suspended.

1. The term of suspension shall be limited to six months or the period of certification whichever is longer.

2. The environmental laboratory shall not continue to analyze samples or report analysis for the fields of certification for which DCLS has suspended certification.

3. The environmental laboratory shall retain certification for the fields of certification, methods, and analytes where it continues to meet the requirements of this chapter.

4. The laboratory's suspended certification status shall change to certified when the laboratory demonstrates to DCLS that the laboratory has corrected the deficiency or deficiencies for which its certification was suspended.

5. An environmental laboratory with suspended certification shall not have to reapply for certification if the cause or causes for suspension are corrected within the term of suspension.

6. If the laboratory fails to correct the causes of suspension within the term of suspension, DCLS shall decertify the laboratory in total or in part.

1VAC30-45-100. Decertification.

A. DGS-DCLS DCLS shall decertify an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

B. DGS-DCLS DCLS may decertify an environmental laboratory in part or in total when the laboratory has failed to do any of the following:

1. Participate in the proficiency testing program as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

2. Complete Satisfactorily complete proficiency testing studies and maintain a history of at least two successful proficiency testing studies for each affected certified field of testing out of the three most recent proficiency testing studies as defined in as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

3. Maintain a quality system as defined in Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

4. Employ staff that meet meets the personnel qualifications in Article 1 (1VAC30-45-200 et seq.) of Part II of this chapter.

5. Submit an acceptable corrective action report plan after two opportunities as specified in 1VAC30-45-390.

6. Implement corrective action specified in the laboratory's corrective action report plan as set out under 1VAC30-45-390.

7. Notify DGS-DCLS DCLS of any changes in key certification criteria as set forth in 1VAC30-45-90.

8. Use accurate references to the laboratory's certification status in the laboratory's documentation.

9. Allow a DCLS assessment team entry during normal business hours to conduct an on-site assessment required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

10. Pay the required fees specified in 1VAC30-45-130.

C. DGS-DCLS DCLS shall follow the process specified in 1VAC30-45-110 when decertifying an environmental laboratory.

D. Responsibilities of the environmental laboratory and DGS-DCLS DCLS when certification has been withdrawn.

1. Laboratories that lose their certification in full shall return their certificate to DGS-DCLS DCLS.

2. If a laboratory loses certification in part, an addendum to the certificate shall be issued by DGS-DCLS DCLS shall issue a revised certificate to the laboratory.

3. When the environmental laboratory has lost certification in full or in part, the laboratory shall not continue to analyze samples or report analyses for the fields of certification that DCLS has decertified.

E. After correcting the reason or cause for decertification under 1VAC30-45-100 subsection A or B of this section, the laboratory owner may reapply for certification under 1VAC30-45-70.

1VAC30-45-110. Procedures to deny certification, to or decertify a laboratory, and; appeal procedures.

A. Notification.

1. If DGS-DCLS believes it has grounds DCLS becomes aware of a cause to deny certification or to decertify an environmental laboratory, DGS-DCLS DCLS shall notify the environmental laboratory in writing of its intent to hold an informal fact finding under § 2.2-4019 of the Code of Virginia in order to make a decision on the denial of certification or decertification this information and require a response from the responsible official. DGS-DCLS DCLS shall send this notification by certified mail to the responsible official and provide a copy to the manager of the environmental laboratory. The notice of informal fact finding shall provide a detailed explanation of the basis for the notice.

2. For a potential denial of certification, the notice shall state that the laboratory has failed to meet the 1VAC30-45 standards and shall specify one or more of the reasons for denial of certification under 1VAC30-45-70 L, providing a detailed explanation of the basis for the denial of certification.

3. For a potential decertification, the notice shall state that the laboratory has failed to meet the 1VAC30-45 standards and shall specify one or more of the reasons for decertification under 1VAC30-45-100 A or B, providing a detailed explanation of the basis for decertification.

4. In its notice, DCLS shall request the laboratory to notify DCLS in writing if the laboratory believes the agency is incorrect in its determination. Before rendering a decision on decertification or denial of certification, DCLS shall provide the opportunity for the laboratory to meet with DCLS in an informal fact-finding proceeding pursuant to § 2.2-4019 of the Code of Virginia.

5. If the laboratory believes DCLS to be incorrect in its determination, the laboratory shall provide DCLS with a detailed written demonstration of why DCLS should not deny certification to or decertify the laboratory. The laboratory shall include this demonstration in the response required under subdivision 6 of this subsection.

6. The laboratory shall provide DCLS with a written response within 30 calendar days of the date of notification from DCLS. The laboratory shall indicate whether it disputes the DCLS determination provided in the agency notice and whether the laboratory requests an informal fact-finding proceeding. If the laboratory does not respond, DCLS shall render its case decision.

B. Following the informal fact finding held pursuant to § 2.2-4019 of the Code of Virginia, the director shall render a decision regarding certification, and shall send this notification by certified mail to the responsible official and provide a copy to the manager of the environmental laboratory. If the director's decision is adverse to the environmental laboratory, the responsible official may appeal this decision in accordance with § 2.2-4026 of the Code of Virginia and Part 2A of the Rules of the Supreme Court of Virginia.

C. The provisions of this section do not preclude informal discussions between DGS-DCLS and any environmental laboratory that has been notified of a possible denial of certification or of decertification. These informal discussions to resolve the concerns that prompted the notice shall be held prior to the informal fact-finding proceeding.

B. An environmental laboratory may appeal a final decision by DCLS to deny certification to or decertify a laboratory pursuant to the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

D. C. The certification status of an environmental laboratory appealing decertification shall not change pending the final decision of the appeals filed under the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) and Part 2A of the Rules of Supreme Court of Virginia.

1VAC30-45-120. Exemptions.

A. DGS-DCLS DCLS may grant a partial or full exemption from the requirements of this chapter based on compliance and performance.

B. DGS-DCLS DCLS may consider granting an exemption if a laboratory applies for an exemption and has met all certification requirements for a period of four consecutive years.

C. An environmental laboratory may apply for an exemption by submitting a request. The request shall include the following information:

1. The scope of the requested exemption;

2. Whether the exemption should be partial or total;

3. If partial, what form the exemption will take; and

4. Why the exemption is appropriate.

D. Upon receiving an application for an exemption, DGS-DCLS DCLS shall provide notice of the request for an exemption in the Virginia Register of Regulations.

E. The notice shall provide a 30-day comment period on the request and shall specify the nature of the request.

F. DGS-DCLS DCLS shall grant or deny the exemption request and provide a written response to the requesting laboratory within 90 calendar days of receipt of the request.

G. Exemptions granted by DGS-DCLS DCLS shall be for a period of no more than 24 months.

1VAC30-45-130. Fees.

A. General.

1. Fees shall be submitted with all applications, including reapplications, for certification and all renewal applications for certification. Applications shall not be designated as complete until the fee is received by DGS-DCLS. Environmental laboratories shall pay a fee with all applications, including reapplications, for certification. DCLS shall not designate an application as complete until it receives payment of the fee.

2. Each certified environmental laboratory shall pay an annual fee to maintain its certification. DCLS shall send an invoice to the certified environmental laboratory.

3. Fees shall be nonrefundable.

B. Fee computation.

1. Fees shall be computed based on the test methods for which a laboratory seeks certification and on the laboratory type. For the purpose of fee calculation, the designations for the laboratory type are (i) a general environmental laboratory or (ii) an environmental laboratory performing only simple test procedures.

2. The fee shall be the total of the base fee and the test category fees for the specific laboratory type to be certified.

3. The test category fees cover categories for the test methods to be certified as specified in the laboratory's application.

4. If the total of the base fee and the test category fees is more than the maximum fee designated for the specific laboratory type to be certified, the laboratory shall pay the maximum fee.

C. Laboratories B. Environmental laboratories performing only simple test procedures shall pay an annual fee of $600.

1. The base fee shall be $100.

2. The maximum fee shall be $600.

D. General environmental laboratories.

1. The base fee shall be $1,700.

2. The maximum fee shall be $5,200.

E. Test category fees.

1. Fees shall be charged for each category of tests to be certified.

2. The fee for each category includes one or more analytical methods unless otherwise specified. With the exception of the test categories labeled oxygen demand and physical, test categories related to test methods for water are defined by 40 CFR 136.3.

3. Fees.

TEST CATEGORY	FEE
Oxygen demand (BOD or COD)	$375
Bacteriology	$375
Inorganic chemistry, fewer than four methods	$375
Inorganic chemistry, four or more methods	$750
Chemistry metals, one – two methods	$450
Chemistry metals, more than two methods	$1,000
Organic chemistry, fewer than four methods	$600
Organic chemistry, four or more methods	$1,200
Aquatic toxicity, acute methods only	$400
Aquatic toxicity, acute and chronic methods	$700
Radiochemical	$1,000
Physical	$375

C. Fee computation for general environmental laboratories.

1. Fees shall be applied on an annual basis.

2. Environmental laboratories shall pay the total of the base fee and the test category fees set out in subsections D and E of this section.

D. Base fees for general environmental laboratories.

1. DCLS determines the base fee for a laboratory by taking into account both the total number of methods and the total number of field of certification matrices for which the laboratory would be certified.

2. DCLS shall charge the base fees set out in Table 1. The base fee for a laboratory is located by first finding the row for the total number of methods to be certified and then finding the box on that row located in the column headed by the total number of matrices to be certified. For example, DCLS charges a base fee of $1300 to a laboratory performing a total of eight methods for one matrix.

TABLE 1: BASE FEES
Number of Methods	1 Matrix	2 Matrices
1 - 9	$1300	$1430
10 - 29	$1400	$1575
30 - 99	$1550	$1825

E. Test category fees for general environmental laboratories.

1. The test category fees cover the types of testing for which a laboratory may be certified as specified in the laboratory's application or as certified at the time of annual billing.

2. Fees shall be charged for each category of tests to be certified.

3. Fees shall be charged for the total number of field of certification matrices to be certified under the specific test category. For example, if a laboratory is performing inorganic chemistry for both nonpotable water and solid and chemical materials matrices, the fee for this test category would be found in the column for two matrices.

4. The fee for each category includes one or more analytical methods unless otherwise specified.

5. DCLS shall charge the test category fees set out in Table 2. The test category fees for a laboratory are located by first finding the row with the total number of test methods for the test category to be certified. The fee to be charged for the test category will be found on that row in the column headed by the total number of matrices to be certified. A laboratory performing four test methods for inorganic chemistry in nonpotable water and solid and chemical materials (two matrices) would be charged a test category fee of $375.

6. Noncommercial environmental laboratories that perform toxicity, radiochemical, or asbestos testing shall pay the test category fees established for these types of testing in 1VAC30-46-150.

TABLE 2: TEST CATEGORY FEES
Test Category	Fees by Number of Matrices
	One	Two
Oxygen demand	$225	$335
Bacteriology, 1 - 3 total methods	$175	$265
Bacteriology, 4 or more total methods	$220	$330
Physical, 1 - 5 total methods	$175	$265
Physical, 6 - 10 total methods	$220	$330
Inorganic chemistry, 1 - 10 total methods	$250	$375
Inorganic chemistry, 11 - 20 total methods	$315	$475
Inorganic chemistry, 21 - 49 total methods	$394	$590
Chemistry metals, 1 - 5 total methods	$325	$490
Chemistry metals, 6 - 20 total methods	$410	$615
Organic chemistry, 1 - 5 total methods	$400	$600
Organic chemistry, 6 - 20 total methods	$500	$750

7. Fee examples. Three examples are provided.

a. Example 1:

Base Fee	One matrix and four test methods	$1300
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (2 methods)	$175
Nonpotable Water	Oxygen demand (1 method)	$225
Nonpotable Water	Physical (1)	$175
TOTAL		$1875

b. Example 2:

Base Fee	One matrix and 15 test methods	$1400
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (2 methods)	$175
Nonpotable Water	Inorganic chemistry (9 methods)	$250
Nonpotable Water	Chemistry metals (2 methods)	$325
Nonpotable Water	Oxygen demand (1 method)	$225
Nonpotable Water	Physical (1)	$175
TOTAL		$2550

c. Example 3:

Base Fee	Two matrices and 27 test methods	$1575
Test Category Fees
One Matrix
Nonpotable Water	Bacteriology (4 methods)	$220
Nonpotable Water	Oxygen demand (1 method)	$225
Solid and Chemical Materials	Chemistry metals (1 method)	$325
Two Matrices
Nonpotable Water and Solid and Chemical Materials	Inorganic chemistry (13 methods)	$475
Nonpotable Water and Solid and Chemical Materials	Physical (7 methods)	$330
TOTAL		$3150

F. Additional fees. Additional fees shall be charged to laboratories applying for the following: (i) modification to scope of certification under 1VAC30-45-90 B, (ii) transfer of ownership under 1VAC30-45-90 C, (iii) exemption under 1VAC30-45-120, (iv) request that multiple noncontiguous laboratory sites be considered as one site under 1VAC30-45-60 B 3, or (v) (iv) petition for a variance under 1VAC30-45-140.

1. For any certified environmental laboratory that applies to modify its scope of certification as specified under 1VAC30-45-90 B, DCLS shall assess a fee determined by the method in subsection G of this section.

2. Under 1VAC30-45-90 C, DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DCLS shall assess a fee determined by the method in subsection G of this section. If, under 1VAC30-45-90 C, DCLS determines that the change of ownership or location of laboratory requires recertification of or reapplication by the laboratory, the laboratory shall pay the application fees required under this section.

1. 3. General environmental laboratories applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $250 and if the exemption is granted, up to an additional $1,000 depending on the scope of the exemption. $700 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. Laboratories performing only simple test procedures applying for an exemption under 1VAC30-45-120 shall pay an initial application fee of $100 and if the exemption is granted, up to an additional $1,000 depending on the scope of the exemption. The fee assessed for the scope of the exemption shall be based on the actual time needed for DGS-DCLS to make the determination $300 plus an additional fee based on the actual time needed for DCLS to assess the exemption request. The total fee shall not exceed the actual time DCLS takes to assess the exemption request. The fee assessed shall be calculated using the method in subsection G of this section.

2. For any certified environmental laboratory that applies to modify its scope of certification as specified under 1VAC30-45-90 B, DGS-DCLS shall assess a fee determined by the method in subsection G of this section.

3. Under 1VAC30-45-90 C, DGS-DCLS may charge a transfer fee to a certified laboratory that transfers ownership. A fee shall be charged if DGS-DCLS (i) needs to review documentation sent by the laboratory about the transfer of ownership or (ii) determines that an on-site assessment is necessary to evaluate the effect of the transfer of ownership. DGS-DCLS shall assess a fee determined by the method in subsection G of this section. If DGS-DCLS determines that a fee should be charged, the fee shall be a minimum of $100 and a maximum of $1,000. If, under 1VAC30-45-90 C, DGS-DCLS determines that the change of ownership or location of laboratory requires recertification of or reapplication by the laboratory, the laboratory shall pay the application fees required under this section.

4. Under 1VAC30-45-60 B 3, the owner of multiple noncontiguous laboratories may request that DGS-DCLS consider these laboratories to be one site. If, as a result of the request being granted, DGS-DCLS needs to perform multiple on-site assessments, DGS-DCLS shall charge a fee for the additional on-site assessments. The fee shall be the sum of reasonable travel costs and labor charges for the additional on-site assessments. The labor charges will be determined following the method in subsection G of this section.

5. 4. Under 1VAC30-45-140, any person regulated by this chapter may petition the director to grant a variance from any requirement of this chapter. DGS-DCLS DCLS shall charge a an initial fee for the time needed of $700 plus an additional fee based on the actual time needed for DCLS to review the petition, including any on-site assessment required. The total fee shall not exceed the actual time DCLS takes to review and make a determination on the request for a variance. The fee shall be determined by the method specified in subsection G of this section.

G. Fee determination.

1. The fee shall be the sum of the total hourly charges for all reviewers plus any on-site review costs incurred.

2. An hourly charge per reviewer shall be determined by (i) obtaining a yearly cost by multiplying the reviewer's annual salary by 1.35 (accounts for overhead such as taxes and insurance) and then (ii) dividing the yearly cost by 1,642 (number of annual hours established by Fiscal Services, DGS, for billing purposes).

3. The charge per reviewer shall be determined by multiplying the number of hours expended in the review by the reviewer's hourly charge.

4. If an on-site review is required, travel time and on-site review time shall be charged at the same hourly charge per reviewer, and any travel expenses shall be added.

H. Out-of-state laboratories - travel costs. The owner of an environmental laboratory located in another state who applies for certification under this chapter shall also pay a fee equal to the reasonable travel costs associated with conducting an on-site assessment at the laboratory. Reasonable travel costs include transportation, lodging, per diem, and telephone and duplication charges.

I. DGS-DCLS DCLS shall derive the travel costs charged under subsections G and H of this section from the Commonwealth of Virginia reimbursement allowances and rates for lodging, per diem, and mileage.

Article 2
On-Site Assessment

1VAC30-45-300. Frequency of on-site assessment.

A. [ Frequency.

1. ] A comprehensive on-site assessment shall be conducted of each laboratory as a condition for granting certification initially and at renewal every two years.

[ 2. ] DCLS shall reassess each certified laboratory [ every two years at least once every three years ] starting from the date of the previous assessment plus or minus six months.

[ 3. DCLS may conduct an on-site assessment of a laboratory every two years plus or minus six months under any of the following circumstances:

a. When a laboratory has received "not acceptable" PT results.

b. When a laboratory's corrective action presented to VELAP for "not acceptable" PT studies does not identify and correct the root cause of the PT study failure.

c. When DCLS has suspended certification for a laboratory in full or in part.

d. When on-site observations include nonconformances previously identified at an on-site assessment, indicating the corrective action was not implemented or not maintained.

e. When on-site observations include failure to qualify nonconforming data to the data user.

f. When on-site observations indicate the laboratory's failure to monitor and maintain regulatory conformance in documentation, traceability, or quality control requirements such that data generated by the laboratory are of questionable quality or defensibility. ]

B. Other on-site assessments.

1. If DGS-DCLS DCLS identified a deficiency on a previous on-site assessment, the agency may conduct a follow-up on-site assessment.

2. DGS-DCLS DCLS may conduct an on-site assessment when a laboratory applies to modify its scope of certification,; when a transfer of owner occurs that affects personnel, equipment, or the laboratory facilities,; or when a laboratory applies for an exemption or a variance. Any other change occurring in a laboratory's operations that might reasonably be expected to alter or impair analytical capability and quality may trigger an on-site assessment.

1VAC30-45-310. Announced and unannounced on-site assessments.

A. DGS-DCLS DCLS may conduct, at its discretion, either announced or unannounced on-site assessments.

B. Advance notice of an assessment shall not be necessary.

C. To the maximum extent practical, DGS-DCLS DCLS, when necessary, shall work with the owner of an environmental laboratory to obtain government security clearances for assessment personnel as far in advance as possible. The owner of the environmental laboratory shall facilitate expeditious attainment of the necessary clearances.

D. To the maximum extent practical, assessment personnel shall minimize disruption of a laboratory's operations and take into account competing demands on the time of laboratory personnel.

1VAC30-45-320. Request for records.

Prior to the actual site visit, DGS-DCLS DCLS may request in writing from a laboratory those records required to be maintained by this chapter.

1VAC30-45-330. Areas to be assessed.

DGS-DCLS DCLS shall assess the laboratory against the personnel and quality control standards in Article 1 (1VAC30-45-200 et seq.) and Article 4 (1VAC30-45-600 et seq.) of this part. The specific areas evaluated in an on-site assessment shall include but not be limited to:

1. Adequacy of the laboratory facility.

2. Organization and management of the laboratory.

3. Qualifications and experience of laboratory personnel.

4. Receipt, tracking and handling of samples.

5. Quantity, condition, and performance of laboratory instrumentation and equipment.

6. Preparation and traceability of calibration standards.

7. Test methods (including the adequacy of the laboratory's standard operating procedures as well as confirmation of the analyst's adherence to SOPs, and the analyst's proficiency with the described task).

8. Data reduction procedures, including an examination of raw data and confirmation that final reported results can be traced to the raw data/original observations.

9. Quality assurance and quality control procedures, including adherence to the laboratory's quality assurance plan and adequacy of the plan.

10. Recordkeeping.

1VAC30-45-340. National security considerations.

A. Assessments at facilities owned or operated by federal agencies or contractors may require security clearances, appropriate badging, or a security briefing before the assessment begins.

B. The laboratory shall notify DGS-DCLS DCLS in writing of any information that is controlled for national security reasons and cannot be released to the public.

1VAC30-45-350. Arrival, admittance, and opening conference.

A. Arrival. Assessment personnel shall arrive at the laboratory during established working hours. The laboratory manager (or, if unavailable, the laboratory manager's designee) shall be located as soon as possible after the assessment personnel arrive on the premises.

B. Admittance of assessment personnel.

1. A laboratory's refusal to admit the assessment personnel for an on-site assessment shall result in an automatic failure of the laboratory to receive certification or loss of an existing certification by the laboratory, unless there are extenuating circumstances that are accepted and documented by DGS-DCLS DCLS. The team leader for the assessment personnel shall notify DGS-DCLS DCLS as soon as possible after refusal of entry.

2. DCLS shall consider any verbal or physical threat to the health and safety of its assessors or any overt antagonism towards its assessors as a refusal to admit the assessors for the purpose of on-site assessment. The assessors shall vacate the laboratory and shall notify DCLS as soon as possible of the circumstances of this refusal to admit. This refusal to admit shall result in an automatic failure of the laboratory to receive certification or the automatic loss of an existing certification by the laboratory.

C. Health and safety.

1. Under no circumstance, and especially as a precondition to gain access to a laboratory, shall assessment personnel be required or even allowed to sign any waiver of responsibility on the part of the laboratory for injuries incurred during an assessment.

2. Assessment personnel shall comply with all facility and laboratory safety procedures.

D. Opening conference. An opening conference shall be conducted and shall address the following topics:

1. The purpose of the assessment;

2. The identification of assessment personnel;

3. The test methods that will be examined;

4. Any pertinent records and procedures to be examined during the assessment and the names of the individuals in the laboratory responsible for providing assessment personnel with such records;

5. The roles and responsibilities of laboratory staff and managers;

6. Any special safety procedures that the laboratory may think necessary for the protection of assessment personnel;

7. The standards and criteria that will be used in judging the adequacy of the laboratory operation;

8. Confirmation of the tentative time for the exit conference; and

9. Discussion of any questions the laboratory may have about the assessment process.

1VAC30-45-380. Closing conference.

A. Assessment personnel shall meet with representatives of the laboratory following the assessment for a closing conference.

B. During the closing conference, assessment personnel shall inform the laboratory of the preliminary findings and the basis for such findings. The laboratory shall have an opportunity to provide further explanation or clarification relevant to the preliminary findings. If the laboratory objects to the preliminary findings during the closing conference, all objections shall be documented by the assessment personnel and included in the final report to DGS-DCLS DCLS.

C. Additional problem areas may be identified in the final report.

D. Any potentially illegal activity that may be the subject of further action shall not be discussed in the closing conference.

1VAC30-45-390. Follow-up and reporting procedures.

A. DGS-DCLS DCLS shall present an assessment report to the laboratory within 30 calendar days of the assessment.

B. If there are deficiencies identified in the assessment report, the laboratory shall have 30 calendar days from the date of its receipt of the assessment report to provide a response to DGS-DCLS DCLS. This response shall be called a corrective action report plan.

C. An exception to the deadlines specified in subsections A and B of this section may occur in appropriate circumstances. Two circumstances that may be considered appropriate by DGS-DCLS DCLS are where a possible enforcement investigation or other action has been initiated or where the laboratory shows good cause for an extension.

D. The corrective action report plan shall include the following:

1. Any objections that the laboratory has with regard to the assessment report;

2. The action that the laboratory proposes to implement to correct each deficiency identified in the assessment report; and

3. The time period required to accomplish the corrective action.

E. DGS-DCLS DCLS shall determine and shall notify the laboratory within 30 calendar days of receipt whether the corrective action report plan is an acceptable response to the deficiencies identified in the assessment report.

F. If the corrective action report plan (or a portion of the report) plan) is determined to be unacceptable to remedy the deficiency, DGS-DCLS DCLS shall provide written notification to the responsible official and manager of the laboratory including a detailed explanation of the basis for such determination. Following receipt of such notification, the laboratory shall have an additional 30 calendar days to submit a revised corrective action report plan acceptable to DGS-DCLS DCLS.

1VAC30-45-400. Documentation of on-site assessment.

A. Checklists. The checklists used by assessment personnel during the assessment shall become a part of DGS-DCLS's DCLS's file for the laboratory.

B. Assessment report format.

1. The final assessment report shall contain a narrative description of the adequacy of the laboratory as it relates to the assessment standards specified in this chapter and in 1VAC30-45-330.

2. Assessment reports shall contain:

a. Name of owner of the laboratory (or operator of the laboratory, if different from the owner);

b. Identification of the laboratory assessed;

c. Date of the assessment;

d. Identification and affiliation of all assessment personnel;

e. Identification of participants in the assessment process;

f. Identification of analytes and test methods assessed;

g. Statement of the objective of the assessment;

h. Summary;

i. Assessment observations, findings (including any deficiencies), objections noted by the laboratory, and requirements; and

j. Comments and recommendations.

3. The assessment findings and requirements shall be referenced to the standards in Part II (1VAC30-45-200 et seq.) of this chapter so that both the finding is understood and the specific requirement is outlined. The assessor shall specify the laboratory records, documents, equipment, procedures, or staff evaluated and the observations that contributed to each identified deficiency. The assessment report shall support with sufficient data all assessment findings and the overall evaluation of the laboratory.

4. The comments and recommendations section may be used to convey recommendations aimed at helping the laboratory improve.

C. Release of report.

1. The assessment report shall be released initially by DGS-DCLS DCLS to the responsible official and the laboratory manager. The assessment report shall not be released to the public until findings of the assessment and the corrective actions have been finalized, all information relating to national security has been stricken from the report in accordance with prescribed procedures, and the report has been provided to the laboratory.

2. Once the assessment report has been released to the laboratory, any member of the public may request a copy of the report under the requirements of the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia).

3. Checklists used by assessment personnel during the on-site assessment shall be provided to the laboratory with the final on-site assessment report [ upon request ].

D. The laboratory shall have access to documentation pertaining to any on-site assessment of its facilities. Any laboratory wishing to review its files shall request such assistance of DGS-DCLS DCLS five days prior to visiting DGS-DCLS DCLS. A laboratory may request copies of its documents without visiting DGS-DCLS DCLS. A reasonable fee may be charged for copying, mailing, and staff time.

Article 3
Proficiency Testing

1VAC30-45-500. Laboratory enrollment in proficiency testing program.

A. Required level of participation.

1. To be certified initially and to maintain certification, a laboratory shall participate in two single-blind, single-concentration PT studies, where available, per year for each PT field of testing for which it seeks or wants to maintain certification. Laboratories applying to be certified for environmental toxicology (aquatic toxicity, sediment toxicity, or soils toxicity) shall meet the requirements of subdivision 3 of this subsection.

2. Laboratories shall obtain PT samples from any PT provider approved under the requirements of the NELAC standards for proficiency test providers set out in Chapter 2 of the 2003 standards such as NIST. For PT fields of testing having no approved providers listed by NELAC, the laboratory shall consult DGS-DCLS for an approved provider.

3. Laboratories applying to be certified for environmental toxicology (aquatic toxicity, sediment toxicity, or soils toxicity). To be certified initially and to maintain certification, a laboratory shall participate in at least one PT study per year (i.e., not more than 12 months apart), when available, for each method code (matrix, organism, exposure system and endpoint) for which it seeks or wants to maintain certification. Laboratories seeking certification for aquatic toxicity testing shall meet the requirements of 1VAC30-45-530.

1. To be certified initially and to maintain certification, a laboratory shall participate in PT studies as specified in 1VAC30-45-520 B for the fields of certification (FoC) for which the laboratory seeks or wants to maintain certification.

2. The applicant laboratory shall obtain PT samples from a PT provider approved by TNI. If a PT sample is not available from a TNI-approved provider, the laboratory shall consult DCLS for an approved provider.

B. Requesting certification.

1. When applying for certification, the laboratory owner shall notify DGS-DCLS DCLS of the fields of testing certification for which the laboratory chooses to become certified and shall participate in the appropriate PT studies.

2. For all fields of testing certification for which PT samples are not available, the laboratory shall ensure the reliability of its testing procedures by maintaining a quality system that meets all applicable requirements of Article 4 (1VAC30-45-600 et seq.) of Part II of this chapter.

C. Reporting results. 1. Each laboratory shall authorize the PT study provider to release all certification and remediation results and "acceptable" or "not acceptable" status the results of the final evaluation report of the laboratory's PT study directly to DGS-DCLS DCLS, in addition to the laboratory.

2. The results of all of the PT sample tests including "acceptable" or "not acceptable" status shall be part of the public record.

1VAC30-45-510. Requirements for laboratory testing of PT study samples.

A. The samples shall be analyzed and the results returned to the PT study provider no later than 45 calendar days from the scheduled study shipment date. Samples for environmental toxicology shall be analyzed within 45 calendar days of sample receipt. The laboratory shall report the result within 45 calendar days of completion of the PT. The laboratory shall report the analytical results from its analysis of the PT study to the PT provider on or before the closing date of the study using the reporting format specified by the PT provider.

B. The laboratory's management and all analysts shall ensure that all PT samples are managed, analyzed, and reported in the same manner as real environmental samples utilizing the same staff, methods as used for routine analysis of that analyte, procedures, equipment, and facilities. When analyzing a PT sample, the laboratory shall employ the same calibration, laboratory quality control and acceptance criteria, sequence of analytical steps, number of replicates and other procedures as used when analyzing routine samples.

C. Restrictions on exchanging information. Laboratories shall comply with all of the following restrictions on the transfer of PT samples and communication of PT sample results prior to the time the results of the study are released. Laboratory management or staff shall not:

1. Send any PT sample, or a portion of a PT sample, to another laboratory for any analysis for which it seeks certification or is certified.

2. Knowingly receive any PT sample or portion of a PT sample from another laboratory for any analysis for which the sending laboratory seeks certification or is certified.

3. Communicate with any individual at another laboratory (including intra-company communication) concerning the PT sample.

4. Attempt to obtain the assigned value of any PT sample from their PT provider.

D. Maintenance of records. The laboratory shall maintain copies of all written, printed, and electronic records, including but not limited to bench sheets, instrument strip charts or printouts, data calculations, and data reports, resulting from the analysis of any PT sample for three years or for as long as is required by the applicable regulatory program. These records shall include a copy of the PT study report forms used by the laboratory to record PT results. All of these laboratory records shall be made available to the DCLS assessors of DGS-DCLS during on-site audits assessments of the laboratory.

1VAC30-45-520. PT criteria for laboratory certification.

A. Result categories.

1. The criteria described in this section apply individually to each PT field of testing FoPT, as defined by the laboratory seeking to obtain or maintain certification in its certification request. These criteria apply only to the PT portion of the overall certification standard.

2. There are two PT result categories: "acceptable" and "not acceptable."

B. Initial and continuing certification.

1. A laboratory seeking to obtain or maintain certification shall successfully complete two PT studies one PT study for each requested PT field of testing within the most recent three rounds attempted FoC.

2. Once a laboratory has been granted certification status, it shall continue to complete PT studies for each PT field of testing FoPT and maintain a history of at least two one acceptable PT studies for each PT field of testing out of the most recent three study each calendar year. The laboratory shall complete its PT studies by September 30 of each calendar year.

3. For a laboratory seeking to obtain initial certification, the most recent three rounds attempted shall have occurred within 18 months of the laboratory's application date. When the PT sample used for initial certification was analyzed by the laboratory prior to the date of application, the analysis date of the PT sample shall be no more than 12 months prior to the application date of certification.

4. For a laboratory seeking initial certification, or for For a laboratory performing supplemental testing, the PT studies shall be at least 15 calendar days apart from the closing date of one study to the shipment date of another study for the same PT field of testing FoPT.

5. For a laboratory to maintain certification, completion dates of successive proficiency rounds for a given PT field of testing shall be approximately six months apart. Failure to meet the semiannual schedule is regarded as a failed study.

5. When the PT study result is reported by the PT provider as "acceptable" the environmental laboratory has satisfied the PT requirement.

6. When the PT study result is "not acceptable," the environmental laboratory shall follow the procedure in subsection C of this section.

7. DCLS shall consider a laboratory's analytical result for a FoPT not acceptable when the laboratory makes any reporting error or omission that results in a nonspecific match between the analytical result for the FoPT and any criterion that identifies the laboratory or the field of certification for which the PT sample was analyzed for the purpose of initial or continued certification.

C. Procedure and requirements for "not acceptable" PT study results.

1. When a laboratory receives a PT study result of "not acceptable," the laboratory shall determine the cause for the failure and perform and document corrective action. The corrective action documentation shall be completed within 30 days of receiving the "not acceptable" PT study result and be submitted to DCLS upon request. [ DCLS may extend the time for corrective action and documentation. ]

2. Upon completion of the corrective action the laboratory shall perform another PT study for each FoPT that had a "not acceptable" result.

3. If the laboratory successfully completes the makeup PT study by receiving an "acceptable" result before December 31, DCLS shall not suspend the laboratory's certification for the pertinent FoC.

4. If the laboratory receives a "not acceptable" result on the makeup PT study, DCLS shall notify the laboratory that there is cause to suspend the laboratory's certification for the FoC for which the PT study was "not acceptable."

5. DCLS shall not extend the period for annual PT study completion beyond December 31 each year. Failure to satisfactorily complete a PT study [ , including any corrective action and makeup PT study, ] by December 31 shall result in suspension of certification in total or in part.

6. If the laboratory receives a "not acceptable" result on three successive PT studies, DCLS shall decertify the laboratory for the pertinent FoC until such time that the laboratory:

a. Completes corrective action for all failed studies and submits its corrective action report to DCLS;

b. Obtains an "acceptable" result for the PT studies; and

c. Applies for a change to its scope of certification and pays applicable fees required by 1VAC30-45-90 B and 1VAC30-45-130 F.

7. DCLS shall follow the provisions of 1VAC30-45-110 in decertifying the laboratory.

C. Supplemental studies.

1. A laboratory may elect to participate in PT studies more frequently than required by the semiannual schedule. This may be desirable, for example, when a laboratory first applies for certification or when a laboratory fails a study and wishes to quickly reestablish its history of successful performance.

2. These additional studies shall be reported and are counted and scored the same way as routinely scheduled studies and shall be at least 15 calendar days apart.

D. Failed studies and corrective action.

1. Whenever a laboratory fails a study, it shall determine the cause for the failure and take any necessary corrective action. It shall then document in its own records and provide to DGS-DCLS both the investigation and the action taken.

2. If a laboratory fails two out of the three most recent studies for a given field of testing, its performance is considered unacceptable for that field. The laboratory shall then meet the requirements of initial certification as described in subsection B of this section.

E. Second failed study.

1. The PT provider reports laboratory PT performance results to DGS-DCLS at the same time that it reports the results to the laboratory.

2. If a laboratory fails a second study out of the most recent three, as described in subdivision D 2 of this section, DGS-DCLS shall take action within 60 calendar days to determine the certification status for the unacceptable PT field of testing.

F. Scheduling of PT studies. Laboratories shall determine the schedule for their PT studies.

G. D. Withdrawal from PT studies. A laboratory may withdraw from a PT study for an analyte or analytes or for the entire study if the laboratory notifies both the PT provider and DGS-DCLS before the closing date of the PT study. This does not exempt the laboratory from participating in the semiannual schedule. any FoPT on or before the close date of the study. Withdrawing from a study shall not exempt the laboratory from meeting the annual analysis requirements necessary for continued certification.

1VAC30-45-530. Special requirements for aquatic toxicity. (Repealed.)

A. Laboratories seeking certification for aquatic toxicity testing shall be assessed through on-site assessment and evaluation of EPA Discharge Monitoring Report-Quality Assurance (DMR-QA) test results when available. A failed DMR-QA endpoint shall require both of the following:

1. A formal response to DGS-DCLS with an explanation of the probable cause for the endpoint failure and description of corrective actions to be taken (where appropriate).

2. A decision by DGS-DCLS to accept the response or require additional actions on the part of the laboratory or by DGS-DCLS.

B. If a laboratory's response is unacceptable and DGS-DCLS does not require additional on-site assessments, the laboratory shall complete another study. Such additional studies shall be conducted at least 15 calendar days from the previous study until the results are acceptable to DGS-DCLS. DGS-DCLS may conduct additional on-site assessments as necessary based on the results of any additional studies.

C. When the DMR-QA whole effluent toxicity portion does not include all test procedures required for a permit, the laboratory shall perform a proficiency test for aquatic toxicity testing.

D. DGS-DCLS shall not base loss of certification for aquatic toxicity testing solely on PT results.

Article 4
Quality System

1VAC30-45-600. Quality system.

A. This article sets out the general requirements that an environmental laboratory has to successfully demonstrate to be recognized as competent to carry out specific environmental tests. The environmental laboratory shall establish, implement and maintain a quality system based on the required elements contained in this article.

B. The quality system shall be appropriate to the type, range and volume of testing, analysis, measurement or monitoring performed by the laboratory.

C. The quality system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. All personnel concerned with testing and calibration activities within the laboratory shall familiarize themselves with the quality documentation and implement the policies and procedures in their work.

C. D. If more stringent standards or requirements are included in a mandated test method or by regulation, the laboratory shall demonstrate that such requirements are met. If it is not clear which standard or requirement is more stringent, the standard or requirement from the method or regulation is to be followed.

D. E. Provisions pertaining to the management of the quality system appear in 1VAC30-45-610 through 1VAC30-45-700. Provisions pertaining to the technical requirements for the quality system appear in 1VAC30-45-710 through 1VAC30-45-770.

1VAC30-45-610. Quality manual.

A. General.

1. The laboratory shall document its quality system in a quality manual. The quality manual shall reflect all quality assurance and quality control practices and programs used by the laboratory. The required elements of the quality system may be described in more than one document.

2. The quality manual shall be maintained current under the responsibility of the quality assurance officer.

3. The quality manual and any related documents shall be communicated to, understood by, available to, and implemented by all laboratory personnel.

4. The quality manual shall include but not be limited to the elements listed in subsection subsections B and C of this section.

B. The elements of a quality manual shall include but not be limited to:

1. Title page. The quality manual shall list the following items on the title page:

a. 1. A document title;

b. 2. The laboratory's full name and address;

c. 3. The name, address (if different from above), and telephone number of the responsible official, laboratory manager, and quality assurance officer;

d. 4. The laboratory facility or facilities covered by the quality manual;

e. 5. Signed and dated concurrence, with appropriate titles, of the responsible official, laboratory manager, and quality assurance officer; and

f. 6. The effective date of the quality manual.;

2. 7. Table of contents. and applicable lists of references, glossaries, and appendices; and

3. 8. A quality policy statement, including objectives of the quality system and commitment to good ethical laboratory practices and to upholding the requirements of this chapter's standards.

C. The quality manual shall include or reference but not be limited to:

4. 1. The organization and management structure of the laboratory, its place in any parent organization and relevant organizational charts.

5. The relationship between management, technical operations, support services and the quality system.

6. The capabilities of the laboratory or scope of its operation.

7. 2. Job descriptions of key staff and reference to the job descriptions of other staff.

8. 3. Processes or procedures for establishing that personnel have adequate training and experience in the duties they are expected to carry out and are receiving any needed training.

9. Ethics policy statement developed by the laboratory. Processes and procedures for educating and training personnel in their ethical and legal responsibilities including the potential penalties for improper, unethical or illegal actions.

10. 4. Mechanisms for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work.

11. 5. Procedures to ensure that all records required by this chapter are retained, as well as procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures, manuals, or documents clearly indicate the time period during which the procedure or document was in force.

12. 6. Procedures for dealing with complaints.

13. 7. Procedures for audits and data review.

14. Reference to verification 8. Verification practices that may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes.

15. 9. Procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur.

16. 10. The laboratory management arrangements for permitting departures from documented policies and procedures or from standard specifications when the departures are planned and controlled.

17. Reference to the 11. The major equipment and reference measurement standards used as well as the physical facility and environment used by the laboratory in conducting tests.

18. Reference to procedures 12. Procedures for calibration, verification and maintenance of equipment.

19. 13. A list of all technology/methods under which the laboratory performs its certified testing.

20. The laboratory's procedures 14. Procedures for achieving traceability of measurements, including standards.

21. 15. Procedures for receiving, handling, storing, and disposing of submitted samples.

22. Reference to procedures 16. Procedures for reporting analytical results.

17. Policy addressing the use of unique electronic signatures, where applicable.

C. D. Review and approval of quality manual.

1. The quality assurance officer shall review the laboratory's quality assurance program, manual and any related documentation whenever there is any change in test methods employed by the laboratory, change in equipment, or any other change in the laboratory that affects the quality assurance program.

2. The quality assurance manual shall be reviewed and approved by the quality assurance officer, the laboratory manager, and the responsible official at least annually.

1VAC30-45-660. Required records.

A. Sample handling.

1. The laboratory shall maintain a record of all procedures to which a sample is subjected while in the possession of the laboratory. These shall include but are not limited to all records pertaining to sample preservation, identification, receipt, acceptance or rejection, log-in, storage and tracking. The laboratory shall also maintain sampling information on each sample. This includes time and date of collection, type of sample (grab or composite), type of container, sampling point and preservation.

2. The laboratory shall have documented procedures for the receipt and retention of samples, including provisions necessary to protect the integrity of the samples.

B. Laboratory support activities. The laboratory shall retain the following documents and data:

1. All original raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts' work sheets and data output records (chromatograms, strip charts, and other instrument response readout records).

2. A written description or reference to the specific test method used that includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value.

3. Copies of final reports.

4. Archived standard operating procedures.

5. Correspondence relating to laboratory activities.

6. All corrective action reports plans, audits, and audit responses.

7. Proficiency test results and raw data.

8. Results of data review, verification, and cross-checking procedures.

C. Analytical records. The laboratory shall retain essential information associated with analytical documents, such as strip charts, tabular printouts, computer data files, analytical notebooks, and run logs. This information includes, but is not limited to, all manual calculations, (e.g., manual integrations); sample preparation; standard and reagent origin, receipt, preparation, and use; quality control protocols and assessment; and method performance criteria.

D. Administrative records. The laboratory shall maintain the following administrative records:

1. Personnel qualifications, experience and training records.

2. Records of demonstration of capability for each analyst or work cell.

3. A log of names, initials and signatures for all individuals who are responsible for signing or initialing any laboratory record.

1VAC30-45-670. Audits.

A. Internal audits.

1. The laboratory shall arrange for annual internal audits to verify that its operations continue to comply with the requirements of the laboratory's quality system. It is the responsibility of the quality assurance officer to plan and organize audits as required by a predetermined schedule and requested by management.

2. Trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited, shall carry out these audits. Personnel shall not audit their own activities except when it can be demonstrated that an effective audit will be carried out.

3. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibrations or test results, the laboratory shall take immediate corrective action.

4. A laboratory may have an audit performed under contract by an outside source competent to audit the laboratory's operations.

B. Managerial review.

1. The laboratory management shall conduct a review, at least annually, of its quality system and its testing and calibration activities to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements in the quality system and laboratory operations.

2. The review shall take account of reports from managerial and supervisory personnel, the outcome of recent internal audits, assessments by external bodies, the results of inter-laboratory comparisons or proficiency tests, corrective actions and other relevant factors.

3. The laboratory shall have a procedure for review by management and maintain records of review findings and actions.

4. Where the staff of a laboratory is limited to a single analyst, a supervisor may perform a managerial review.

C. Audit review. All audit and review findings and any corrective actions that arise from them shall be documented. The laboratory management shall ensure that these actions are discharged within the agreed [ time frame timeframe ] as indicated in the quality manual or standard operating procedures or both. For clarification, documentation of audit and review findings should be a simple procedure, essentially a memorandum setting out the findings of the audit and managerial review and any action to follow.

D. Corrective actions.

1. In addition to providing acceptance criteria and specific protocols for corrective actions in the method standard operating procedures, the laboratory shall implement general procedures to be followed to determine consistently when departures from documented policies, procedures and quality control have occurred. These procedures may include but are not limited to the following:

a. Identify the individual or individuals responsible for assessing each quality control data type;

b. Identify the individual or individuals responsible for initiating or recommending corrective actions or both;

c. Define how the analyst shall treat a data set if the associated quality control measurements are unacceptable;

d. Specify how out-of-control situations and subsequent corrective actions are to be documented; and

e. Specify procedures for management (including the quality assurance officer) to review corrective action reports plans.

2. To the extent possible, samples shall be reported only if all quality control measures are acceptable. If a quality control measure is found to be out of control, and the data are to be reported, all samples associated with the failed quality control measure shall be reported with the appropriate data qualifiers.

1VAC30-45-720. Equipment and reference materials.

A. The laboratory shall be furnished with all items of equipment, including reference materials, required for the correct performance of tests for which certification is sought. The laboratory shall maintain records of reference materials sufficient to provide proper performance of tests. In those cases where the laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements of this article are met.

B. All equipment shall be properly maintained, inspected and cleaned. Maintenance procedures shall be documented.

C. Any item of the equipment that has been subjected to overloading or mishandling, or that gives suspect results, or has been shown by verification or otherwise to be defective shall be taken out of service immediately, clearly identified as being out of service and, wherever possible, stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests.

D. Each item of equipment including reference materials shall be labeled, marked or otherwise identified to indicate its calibration status.

E. Records of each major item of equipment significant to the tests performed shall be maintained. These records shall include documentation on all routine and non-routine maintenance activities. The laboratory shall maintain records of reference materials sufficient to provide proper performance of tests. The records shall include:

1. The name of the item of equipment;

2. The manufacturer's name, type identification, and serial number or other unique identification;

3. Date received and date placed in service (if available);

4. 3. Current location, where appropriate;

5. If available, condition when received (e.g., new, used, reconditioned);

6. 4. Copy of the manufacturer's instructions, where available;

7. 5. Dates and results of calibrations or verifications or both and date of the next calibration or verification;

8. 6. Details of maintenance carried out to date and planned for the future; and

9. 7. History of any damage, malfunction, modification or repair.

1VAC30-45-730. Test methods and standard operating procedures.

A. Methods documentation.

1. The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of samples, and for calibration or testing, where the absence of such instructions could jeopardize the calibrations or tests.

2. All instructions, standards, manuals and reference data relevant to the work of the laboratory shall be maintained up to date and be readily available to the staff.

B. Standard operating procedures (SOPs).

1. Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities such as assessing data integrity, corrective actions, handling customer complaints, and all test methods. These documents, for example, may be equipment manuals provided by the manufacturer or internally written documents. The test methods may be copies of published methods as long as any changes or selected options in the methods are documented and included in the laboratory methods manual.

2. The SOPs shall be organized. Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature or signatures of the responsible laboratory manager or managers.

3. Copies of all SOPs shall be accessible to all personnel.

C. Laboratory methods manuals. SOPs for laboratory methods.

1. The laboratory shall have and maintain an in-house methods manual or manuals SOP for each certified analyte or test method.

2. This manual may consists of copies of published or referenced methods or standard operating procedures that have been SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced test method is ambiguous or provides insufficient detail, these changes or clarifications shall be clearly described. Each test method shall include or reference where applicable:

a. Identification of the test method;

b. Applicable matrix or matrices;

c. Method detection limit Limits of detection or quantitation;

d. Scope and application, including components parameters to be analyzed;

e. Summary of the test method;

f. Definitions;

g. Interferences;

h. Safety;

i. Equipment and supplies;

j. Reagents and standards;

k. Sample collection, preservation, shipment and storage;

l. Quality control;

m. Calibration and standardization;

n. Procedure;

o. Calculations Data analysis and calculations;

p. Method performance;

q. Pollution prevention;

r. Data assessment and acceptance criteria for quality control measures;

s. Corrective actions for out-of-control data;

t. Contingencies for handling out-of-control or unacceptable data;

u. Waste management;

v. References; and

w. Any tables, diagrams, flowcharts and validation data.

D. Test methods.

1. Laboratories shall use (i) promulgated test methods in accordance with the Code of Federal Regulations; (ii) test methods stated in any current permit issued by Virginia the State Air Pollution Control Board, the Virginia Waste Management Board, or the State Water Control Board; or (iii) alternate test procedures approved by the board issuing the permit or the Department of Environmental Quality, including applicable quality assurance requirements, and sample preservation, container, storage, and holding time requirements. [ Laboratories shall use the latest valid edition of a method unless it is not appropriate to do so. ]

2. The laboratory shall use appropriate test methods and procedures for all tests and related activities within its responsibility (including sample handling, transport and storage, preparation and analysis). The method and procedures shall be consistent with the accuracy required and with any standard specifications relevant to the calibrations or tests concerned.

3. When the use of reference test methods for a sample analysis is mandated, only those methods shall be used.

4. Where test methods are employed that are not required, as in the Performance Based Measurement System approach, the methods shall be fully documented and validated (see subsection E of this section).

E. Demonstration of capability.

1. Prior to acceptance and institution of any test method, satisfactory initial demonstration of method capability is required. In general, this demonstration does not test the performance of the method in real world samples, but in the applicable and available clean quality system matrix sample (a quality system matrix in which no target analytes or interferences are present at concentrations that impact the results of a specific test method), e.g. for example, drinking water, solids, biological tissue and air. Laboratories shall follow the procedure in subsection F of this section to demonstrate capability.

2. Thereafter, continuing ongoing demonstration of method performance, such as laboratory control samples, is required.

3. In cases where a laboratory analyzes samples using a test method that has been in use by the laboratory before July 1999 for at least one year prior to applying for certification, and there have been no significant changes in instrument type, personnel or test method, the continuing demonstration of method performance and the analyst's documentation of continued proficiency shall be acceptable. The laboratory shall have records on file to demonstrate that an initial demonstration of capability is not required.

4. In all cases, the laboratory shall [ complete and retain a certification statement and shall make the statement available upon request. The laboratory shall retain all associated supporting data necessary to reproduce the analytical results summarized in the certification statement document each demonstration of capability as required by subsection G of this section ].

5. The laboratory shall complete a demonstration of capability each time there is a change in instrument type, personnel or test method, including the addition of an analyte to a certified test method.

6. In laboratories with specialized work cells (a group consisting of analysts with specifically defined tasks that together perform the test method), the group as a unit shall meet the criteria of this subsection. This demonstration of capability shall be fully documented.

F. Procedure for demonstration of capability. The following steps shall be performed for mandated test methods. However, before any results are reported using this method, actual sample spike results may be used to meet this standard, (i.e., at least four consecutive matrix spikes within the last 12 months). For analytes that do not lend themselves to spiking, (e.g., TSS), the demonstration of capability may be performed using quality control samples. The laboratory may document that other approaches to demonstration of capability are adequate. This documentation shall be included in the laboratory's quality manual:

1. A quality control (QC) sample may be obtained from an outside source or may be prepared by the laboratory using alternate source stock standards that are prepared independently from those used in instrument calibration.

2. The analyte or analytes shall be diluted in a volume of clean quality system matrix sufficient to prepare four aliquots at the concentration specified, or if unspecified, to a concentration of 1-4 times the limit of quantitation.

3. At least four aliquots shall be prepared and analyzed according to the test method either concurrently or over a period of days.

4. Using all of the results, calculate the mean recovery in the appropriate reporting units (such as g/L) and the standard deviations of the population sample (n-1) (in the same units) for each parameter of interest. When it is not possible to determine mean and standard deviations, such as for presence or absence of the analyte and logarithmic values, the laboratory shall assess performance against established and documented criteria.

5. Compare the information from subdivision 4 of this subsection to the corresponding acceptance criteria for precision and accuracy in the test method (if applicable) or in laboratory-generated acceptance criteria (if there are not established mandatory criteria). If all parameters meet the acceptance criteria, the analysis of actual samples may begin. If any one of the parameters do not meet the acceptance criteria, the performance is unacceptable for that parameter.

6. When one or more of the tested parameters fail at least one of the acceptance criteria, the analyst shall proceed according to either subdivision 6 a or 6 b below of this subsection.

a. Locate and correct the source of the problem and repeat the test for all parameters of interest beginning with subdivision 3 of this subsection.

b. Beginning with subdivision 3 of this subsection, repeat the test for all parameters that failed to meet criteria. Repeated failure, however, confirms a general problem with the measurement system. If this occurs, locate and correct the source of the problem and repeat the test for all compounds of interest beginning with subdivision 3 of this subsection.

[ G. Certification statement. The following certification statement shall be used to document the completion of each demonstration of capability. A copy of the certification statement shall be retained in the personnel records of each affected employee.

Demonstration of Capability
Certification Statement

Date: Page __of __

Laboratory Name:

Laboratory Address:

Analyst(s) Name(s):

Matrix:

(examples: laboratory pure water, soil, air, solid, biological tissue)

Method number, SOP#, Rev#, and Analyte, or Class of Analytes or Measured Parameters

(examples: barium by 200.7, trace metals by 6010 B, benzene by 8021 B, etc.)

We, the undersigned, CERTIFY that:

1. The analysts identified above, using the cited test method(s), which is in use at this facility for the analyses of samples under the Virginia Environmental Laboratory Certification Program, have met the Demonstration of Capability.

2. The test method(s) was performed by the analyst(s) identified on this certification.

3. A copy of the test method(s) and the laboratory-specific SOPs are available for all personnel on-site.

4. The data associated with the demonstration capability are true, accurate, complete and self-explanatory⁽¹⁾.

5. All raw data (including a copy of this certification form) necessary to reconstruct and validate these analyses have been retained at the facility, and that the associated information is well organized and available for review by authorized assessors.

Laboratory Manager's Name and Title________________ Signature________________ Date_______

Quality Assurance Officer's Name___________________ Signature________________ Date_______

⁽¹⁾True - consistent with supporting data. Accurate - based on good laboratory practices consistent with sound scientific principles and practices. Complete - includes the results of all supporting performance testing. Self-explanatory - data properly labeled and stored so that the results are clear and require no additional explanation.

G. Documentation of demonstration of capability. The laboratory shall document each demonstration of capability so that the following information shall be readily available for each employee:

1. Analyst or analysts involved in preparation and analysis.

2. Matrix.

3. Analytes, class of analytes, measured parameters, or organisms.

4. Identification of methods performed.

5. Identification of laboratory-specific SOP used for analysis, including revision number.

6. Date or dates of analysis.

7. All raw data necessary to reconstruct and validate the analyses.

8. Data evaluation required by subsection F of this section. ]

H. Sample aliquots. Where sampling (as in obtaining sample aliquots from a submitted sample) is carried out as part of the test method, the laboratory shall use documented procedures and appropriate techniques to obtain representative subsamples.

I. Data verification. Calculations and data transfers shall be subject to appropriate checks. The laboratory shall establish standard operating procedures to ensure that (i) the reported data are free from transcription and calculation errors and (ii) all quality control measures are reviewed and evaluated before data are reported. The laboratory also shall establish standard operating procedures addressing manual calculations including manual integrations.

J. Documentation and labeling of standards and reagents. Documented procedures shall exist for the reception and storage of consumable materials used for the technical operations of the laboratory.

1. The laboratory shall retain records for all standards, reagents, reference materials and media including the manufacturer/vendor, the manufacturer's Certificate of Analysis or purity (if available), the date of receipt, recommended storage conditions, and an expiration date after which the material shall not be used unless its reliability is verified by the laboratory.

2. Original containers (such as provided by the manufacturer or vendor) shall be labeled with an expiration date if this date is provided by the manufacturer or vendor.

3. Records shall be maintained on standard and reference material preparation. These records shall indicate traceability to purchased stocks or neat compounds, reference to the method of preparation, date of preparation, expiration date and preparer's initials.

4. Sufficient identification of containers of prepared reagents and standards shall be provided to ensure proper performance of tests.

K. Computers and electronic data related requirements. Where computers, automated equipment or microprocessors are used for the capture, processing, manipulation, recording, reporting, storage or retrieval of test data, the laboratory shall ensure the following:

1. Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use.

2. Procedures are established and implemented for protecting the integrity of data, such as integrity of data entry or capture, data storage, data transmission and data processing.

3. Computer and automated equipment are maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration and test data.

4. Appropriate procedures are established and implemented for the maintenance of security of data including the prevention of unauthorized access to, and the unauthorized amendment of, computer records.

1VAC30-45-740. Measurement traceability and calibration.

A. General requirements. All equipment used for environmental tests, including equipment for subsidiary measurements (e.g., for environmental conditions) having a significant effect on the accuracy or validity of the result of the environmental test or sampling shall be calibrated before being put into service and on a continuing basis. The laboratory shall have an established program and procedure for the calibration of its equipment. This includes balances, thermistors, thermometers and control standards. Such a program shall include a system for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform environmental tests.

B. Traceability of calibration.

1. The laboratory shall ensure that the equipment used can provide the uncertainty of measurement needed.

2. The overall program of calibration or verification or both and validation of equipment shall be designed and operated so as to ensure that measurements made by the laboratory are traceable to national standards of measurement.

3. Where traceability of measurements to the International System of Units (SI) is not possible or not relevant, the same requirements for traceability to, for example, certified reference materials, agreed methods and/or or consensus standards, are required. The laboratory shall provide satisfactory evidence of correlation of results, for example by participation in a suitable program of inter-laboratory comparisons, proficiency testing, or independent analysis.

C. Reference standards and reference materials.

1. Reference standards. The laboratory shall have a program and procedure for the calibration of its reference standards. Reference standards of measurement shall be calibrated by a body that can provide traceability as described in subsection B of this section. Such reference standards of measurement held by the laboratory (such as Class S or equivalent weights or traceable thermometers) shall be used for calibration only and for no other purpose, unless it can be demonstrated that their performance as reference standards would not be invalidated. Where commercially available, this traceability shall be to a national standard of measurement.

2. Reference materials. Reference materials shall, where commercially available, be traceable to SI units of measurement, or to certified reference materials. Where possible, traceability shall be to national or international standards of measurement, or to national or international standard reference materials. Internal reference materials shall be checked as far as is technically and economically practicable.

D. Calibration. Calibration requirements are divided into two parts: (i) requirements for analytical support equipment and (ii) requirements for instrument calibration. In addition, the requirements for instrument calibration are divided into initial instrument calibration and continuing instrument calibration verification.

1. Support equipment. These standards apply to all devices that may not be the actual test instrument, but are necessary to support laboratory operations. These include but are not limited to balances, ovens, refrigerators, freezers, incubators, water baths, temperature measuring devices (including thermometers and thermistors), thermal/pressure sample preparation devices and volumetric dispensing devices (such as Eppendorf®, or automatic dilutor or dispensing devices) if quantitative results are dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified volume.

a. All support equipment shall be maintained in proper working order. The records of all repair and maintenance activities, including service calls, shall be kept.

b. All support equipment shall be calibrated or verified at least annually, using NIST traceable references when available, over the entire range of use. The results of such calibration shall be within the specifications required of the application for which this equipment is used. If not, the laboratory shall either (i) remove the equipment from service until repaired or (ii) maintain records of established correction factors to correct all measurements.

c. Raw data records shall be retained to document equipment performance.

d. Prior to use on each working day On each day the equipment is used, balances, ovens, refrigerators, freezers, and water baths shall be checked in the expected use range, with NIST traceable references where available. The acceptability for use or continued use shall be according to the needs of the analysis or application for which the equipment is being used.

e. Mechanical volumetric dispensing devices including burettes (except Class A glassware) shall be checked for accuracy on at least a quarterly use basis. Glass microliter syringes are to be considered in the same manner as Class A glassware, but shall come with a certificate attesting to established accuracy or the accuracy shall be initially demonstrated and documented by the laboratory.

f. For chemical tests, the temperature, cycle time and pressure of each run of autoclaves shall be documented by the use of appropriate chemical indicators or temperature recorders and pressure gauges.

g. For biological tests that employ autoclave sterilization, the following requirements apply:

(1) The performance of each autoclave shall be initially evaluated by establishing its functional properties and performance, for example heat distribution characteristics with respect to typical uses. Autoclaves shall meet specified temperature tolerances. Pressure cookers fitted only with a pressure gauge are not recommended for sterilization of media or decontamination of wastes.

(2) Records of autoclave operations including temperature and time shall be maintained. This shall be done for every cycle. Acceptance and rejection criteria shall be established and used to evaluate the autoclave efficiency and effectiveness.

2. Instrument calibration.

a. This standard specifies the essential elements that define the procedures and documentation for initial instrument calibration and continuing instrument calibration verification to ensure that the data shall be of known quality and be appropriate for a given regulation or decision. This standard does not specify detailed procedural steps for calibration, but establishes the essential elements for selection of the appropriate technique or techniques. If more stringent standards or requirements are included in a mandated test method or by regulation, the laboratory shall demonstrate that such requirements are met. If it is not apparent which standard is more stringent, then the requirements of the regulation or mandated test method are to be followed.

b. Initial instrument calibrations. The following items are essential elements of initial instrument calibration:

(1) The laboratory shall include or reference the details of the initial instrument calibration procedures, including calculations, integrations, acceptance criteria and associated statistics in the standard operating procedure for the test method. When initial instrument calibration procedures are referenced in the test method, then the laboratory shall retain the referenced material and make it available for review.

(2) The laboratory shall retain sufficient raw data records to permit reconstruction of the initial instrument calibration, (e.g., calibration date, test method, instrument, analysis date, each analyte name, analyst's initials or signature, concentration and response, calibration curve or response factor, or unique equation or coefficient used to reduce instrument responses to concentration).

(3) Sample results shall be quantitated from the initial instrument calibration and may not be quantitated from any continuing instrument calibration verification unless otherwise required by regulation, method, or program.

(4) All initial instrument calibrations shall be verified with a standard obtained from a second manufacturer or lot. Traceability shall be to a national standard, when available. This element does not apply to laboratories performing only simple test procedures.

(5) Criteria for the acceptance of an initial instrument calibration shall be established, (e.g., correlation coefficient and relative percent difference). The criteria used shall be 0.995 or greater for the calibration coefficient unless a different criterion is included in the method being used.

(6) Results of samples not bracketed by initial calibration standards (within calibration range) shall be reported as having less certainty, (e.g., defined qualifiers or flags or explained in the case narrative). The lowest calibration standard shall be above the detection limit.

(7) If the initial instrument calibration results are outside established acceptance criteria, corrective actions shall be performed. Data associated with an unacceptable initial instrument calibration shall not be reported.

(8) Calibration standards shall include concentrations at or below the regulatory limit or decision level, if these limits or levels are known by the laboratory, unless these concentrations are below the laboratory's demonstrated detection limits.

(9) If a reference or mandated method does not specify the number of calibration standards, the minimum number is two, not including blanks or a zero standard. The laboratory shall have a standard operating procedure for determining the number of points for establishing the initial instrument calibration.

c. Continuing instrument calibration verification.

(1) When an initial instrument calibration is not performed on the day of analysis, the validity of the initial calibration shall be verified prior to sample analyses by a continuing instrument calibration check with each analytical batch. This provision does not apply to laboratories performing only simple test procedures.

(2) The following items are essential elements of continuing instrument calibration verification:

(a) The laboratory shall include or reference the details of the continuing instrument calibration procedure, calculations and associated statistics in the standard operating procedure for the test method.

(b) The laboratory shall verify calibration for each compound, element, or other discrete chemical species, except for multicomponent analytes such as Aroclors, Total Petroleum Hydrocarbons, or Toxaphene where a representative chemical related substance or mixture can be used.

(c) The laboratory shall perform a continuing instrument calibration verification as follows:

(i) At the beginning and end of each analytical batch. If an internal standard is used, only one verification needs to be performed at the beginning of the analytical batch;

(ii) Whenever it is expected that the analytical system may be out of calibration or might not meet the verification acceptance criteria;

(iii) If the time period for calibration or the most previous calibration verification has expired; or

(iv) For analytical systems that contain a calibration verification requirement.

(d) Sufficient raw data records shall be retained to permit reconstruction of the continuing instrument calibration verification, (e.g., or test method, instrument, analysis date, each analyte name, concentration and response, calibration curve or response factor, or unique equations or coefficients used to convert instrument responses into concentrations). Continuing calibration verification records shall explicitly connect the continuing verification data to the initial instrument calibration.

(e) Criteria for the acceptance of a continuing instrument calibration verification shall be established, (e.g., percent recovery or relative percent difference).

(f) If the continuing instrument calibration verification results obtained are outside established acceptance criteria, corrective actions shall be performed. If routine corrective action procedures fail to produce a second consecutive (immediate) calibration verification within acceptance criteria, then either the laboratory has to demonstrate acceptable performance after corrective action with two consecutive successful calibration verifications, or a new initial instrument calibration shall be performed. If the laboratory has not verified calibration, sample analyses shall not occur until the analytical system is calibrated or calibration verified. If samples are analyzed using a system on which the calibration has not yet been verified, the results shall be flagged. Data associated with an unacceptable calibration verification may be fully useable under the following special conditions:

(i) When the acceptance criteria for the continuing calibration verification are exceeded high, (i.e., high bias,) and there are associated samples that are nondetects, then those nondetects may be reported. Otherwise the samples affected by the unacceptable calibration verification shall be reanalyzed after a new calibration curve has been established, evaluated and accepted.

(ii) When the acceptance criteria for the continuing calibration verification are exceeded low, (i.e., low bias,) those sample results may be reported if they exceed a maximum regulatory limit or decision level. Otherwise the samples affected by the unacceptable verification shall be reanalyzed after a new calibration curve has been established, evaluated and accepted.

1VAC30-45-750. Quality assurance.

A. General. The laboratory shall have quality control procedures for monitoring the validity of environmental tests undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following:

1. Regular use of certified reference materials and/or or internal quality control using secondary reference materials or both.

2. Participation in interlaboratory comparison or proficiency testing program.

3. Replicate tests using the same or different methods.

4. Retesting of retained samples.

5. Correlation of results for different characteristics of a sample (for example (e.g., total phosphate should be greater than or equal to orthophosphate).

B. Essential quality control procedures. The general quality control principles in [ subsections subsection ] C [ through F ] of this section shall apply, where applicable, to all environmental laboratories. The manner in which they are implemented is dependent on the types of tests performed by the laboratory. 1VAC30-45-760 through 1VAC30-45-829 specify quality control requirements for specific test types. 1VAC30-45-770 through 1VAC30-45-775, 1VAC30-45-790 through 1VAC30-45-798, and 1VAC30-45-810 through 1VAC30-45-818 specify quality control requirements for chemical testing, microbiological testing, and air testing, respectively. Noncommercial environmental laboratories that analyze environmental samples using other types of testing such as toxicity, radiochemical, or asbestos testing shall meet the quality control standards for the specific method and the specific type of testing in the 2009 TNI Standards for Environmental Laboratories. The standards for any given test type shall assure that the applicable principles are addressed.

C. All laboratories shall have detailed written protocols in place to monitor the following quality controls:

1. Positive and negative controls to monitor tests such as blanks, spikes, reference toxicants.

2. Tests to define the variability or repeatability of the laboratory results or both such as replicates.

3. Measures to assure the accuracy of the test method including calibration or continuing calibrations or both, use of certified reference materials, proficiency test samples, or other measures.

4. Measures to evaluate test method capability, such as method detection limits and quantitation limits or range of applicability such as linearity.

5. Selection of appropriate formulae to reduce raw data to final results such as regression analysis, comparison to internal and external standard calculations, and statistical analyses.

6. Selection and use of reagents and standards of appropriate quality.

7. Measures to assure the selectivity of the test for its intended purpose.

8. Measures to assure constant and consistent test conditions (both instrumental and environmental) where required by the test method such as temperature, humidity, light, or specific instrument conditions.

1VAC30-45-760. Quality control requirements.

A. General.

1. The quality control protocols specified by the laboratory's method manual SOPs shall be followed (1VAC30-45-730 C). The laboratory shall ensure that either the (i) applicable essential standards outlined in this section through 1VAC30-45-829 1VAC30-45-775, 1VAC30-45-791 through 1VAC30-45-798, and 1VAC30-45-811 or (ii) mandated methods or regulations, whichever are more stringent, are incorporated into their method manuals SOPs. When it is not apparent which is more stringent, the quality control controls in the mandated method or regulations is are to be followed.

2. All quality control measures shall be assessed and evaluated on an ongoing basis and quality control acceptance criteria shall be used to determine the validity of the data. The laboratory shall have procedures for the development of acceptance/rejection criteria where no method or regulatory criteria exists.

B. Initial test method evaluation. For all test methods other than toxicity and microbiology, the requirements of subdivisions 1 and 2 of this subsection apply. For toxicity and microbiology testing, the initial test method evaluation requirements are contained in 1VAC30-45-780 through 1VAC30-45-788 and 1VAC30-45-790 through 1VAC30-45-798, respectively. For the evaluation of precision and bias (subdivision 3 of this subsection), the requirements of subdivision 3 a of this subsection apply to standard methods. The requirements of subdivision 3 b of this subsection apply to the methods referenced in that subdivision.

1. Limit of detection (LOD).

a. The laboratory shall determine the LOD for the method for each target analyte of concern in the quality system matrices. All sample processing steps of the analytical method shall be included in the determination of the LOD.

b. The validity of the LOD shall be confirmed by qualitative identification of the [ analyte(s) analyte ] in a quality control sample in each quality system matrix containing the analyte at no more than two to three times the LOD for single analyte tests and one to four times the LOD for multiple analyte tests. This verification shall be performed on every instrument that is to be used for analysis of samples and reporting of data.

c. An LOD study is not required for any component for which spiking solutions or quality control samples are not available such as temperature, or, when test results are not to be reported to the LOD (versus the limit of quantitation or working range of instrument calibration), according to 1VAC30-45-771, 1VAC30-45-805, and 1VAC30-45-814, and 1VAC30-45-826. Where an LOD study is not performed, the laboratory may not report a value below the limit of quantitation.

2. Limit of quantitation (LOQ).

a. The laboratory shall determine the LOQ for each analyte of concern according to a defined, documented procedure.

b. The LOQ study is not required for any component or property for which spiking solutions or quality control samples are not commercially available or otherwise inappropriate (e.g., pH).

c. The validity of the LOQ shall be confirmed by successful analysis of a QC sample containing the analytes of concern in each quality system matrix one to two times the claimed LOQ. A successful analysis is one where the recovery of each analyte is within the established test method acceptance criteria or client data quality objectives for accuracy. This single analysis is not required if the bias and precision of the measurement system is evaluated at the LOQ.

3. Evaluation of precision and bias.

a. Standard methods. The laboratory shall evaluate the precision and bias of a standard method for each analyte of concern for each quality system matrix according to either of the following:

(1) The single-concentration four-replicate recovery study procedures in 1VAC30-45-730 F; or

(2) An alternate procedure documented in the quality manual when the analyte cannot be spiked into the sample matrix and quality control samples are not commercially available.

b. Nonstandard methods.

(1) For laboratory-developed test methods or nonstandard test methods that were not in use by the laboratory before July 2003, the laboratory shall have a documented procedure to evaluate precision and bias. The laboratory shall also compare results of the precision and bias measurements with criteria given in the reference method or criteria established by the laboratory.

(2) Precision and bias measurements shall evaluate the method across the analytical calibration range of the method. The laboratory shall also evaluate precision and bias in the relevant quality system matrices and shall process the samples through the entire measurement system for each analyte of interest.

(3) The following are examples of a systematic approach to evaluate precision and bias:

(a) Example 1. Analyze QC samples in triplicate containing the analytes of concern at or near the limit of quantitation, at the upper-range of the calibration (upper 20%) and at a mid-range concentration. Process these samples on different days as three sets of samples through the entire measurement system for each analyte of interest. Each day one QC sample at each concentration is analyzed. A separate method blank shall be subjected to the analytical method along with the QC samples on each of the three days. (Note that the three samples at the LOQ concentration can demonstrate sensitivity as well.) For each analyte, calculate the mean recovery for each day, for each level over days, and for all nine samples. Calculate the relative standard deviation for each of the separate means obtained. Compare the standard deviations for the different days and the standard deviations for the different concentrations. If the different standard deviations are all statistically insignificant (e.g., F-test), then compare the overall mean and standard deviation with the established criteria from above.

(b) Example 2. A validation protocol such as the Tier I, Tier II, and Tier III requirements in U.S. EPA Office of Water's Alternate Test Procedure (ATP) approval process.

4. Evaluation of selectivity. The laboratory shall evaluate selectivity by following the checks established within the method. These checks may include mass spectral tuning, second column confirmation, ICP inter-element interference checks, chromatography retention time windows, sample blanks, spectrochemical absorption or fluorescence profiles, co-precipitation evaluations, and electrode response factors.

1VAC30-45-770. Chemical testing: positive and negative controls.

A. Negative control – method performance.

1. Purpose. The method blank is used to assess the preparation batch for possible contamination during the preparation and processing steps. The method blank shall be processed along with and under the same conditions as the associated samples to include all steps of the analytical procedure. Procedures shall be in place to determine if a method blank is contaminated. Any affected samples associated with a contaminated method blank shall be reprocessed for analysis or the results reported with appropriate data qualifying codes.

2. Frequency. The method blank shall be analyzed at a minimum of one per preparation batch. In those instances for which no separate preparation method is used (example: (e.g., volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of 20 environmental samples.

3. Composition. The method blank shall consist of a quality system matrix that is similar to the associated samples and is known to be free of the analytes of interest.

4. Evaluation criteria and corrective action. While the goal is to have no detectable contaminants, each method blank shall be critically evaluated as to the nature of the interference and the effect on the analysis of each sample within the batch. The source of contamination shall be investigated and measures taken to minimize or eliminate the problem and affected samples reprocessed or data shall be appropriately qualified if:

a. The concentration of a targeted analyte in the blank is at or above the reporting limit as established by the test method or by regulation, and is greater than 1/10 of the amount measured in any sample.

b. The blank contamination otherwise affects the sample results as per the test method requirements or the individual project data quality objectives.

c. When a blank is determined to be contaminated, the cause shall be investigated and measures taken to minimize or eliminate the problem. Samples associated with a contaminated blank shall be evaluated as to the best corrective action for the samples (e.g., reprocessing or data qualifying codes). In all cases the corrective action shall be documented.

B. Positive control – method performance. Laboratory control sample (LCS).

1. Purpose. The LCS is used to evaluate the performance of the total analytical system, including all preparation and analysis steps. Results of the LCS are compared to established criteria and, if found to be outside of these criteria, indicates that the analytical system is "out of control." Any affected samples associated with an out of control LCS shall be reprocessed for re-analysis or the results reported with appropriate data qualifying codes.

2. Frequency. The LCS shall be analyzed at a minimum of one per preparation batch. Exceptions would be for those analytes for which no spiking solutions are available such as total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature, dissolved oxygen or turbidity. In those instances for which no separate preparation method is used (example: volatiles in water) the batch shall be defined as environmental samples that are analyzed together with the same method and personnel, using the same lots of reagents, not to exceed the analysis of 20 environmental samples.

3. Composition. The LCS is a quality system matrix, known to be free of analytes of interest, spiked with known and verified concentrations of analytes. NOTE: the matrix spike may be used in place of this control as long as the acceptance criteria are as stringent as for the LCS. Alternatively the LCS may consist of a media containing known and verified concentrations of analytes or as Certified Reference Material (CRM). All analyte concentrations shall be within the calibration range of the methods. The following shall be used in choosing components for the spike mixtures:

The components to be spiked shall be as specified by the mandated test method or other regulatory requirement or as requested by the client. In the absence of specified spiking components the laboratory shall spike per the following:

a. For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported.

b. For those test methods that have extremely long lists of analytes, a representative number may be chosen. The analytes selected should be representative of all analytes reported. The following criteria shall be used for determining the minimum number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two-year period. For methods that include 1-10 targets, spike all components; for methods that include 11-20 targets, spike at least 10% 10 components or 80%, whichever is greater; and for methods with more than 20 targets, spike at least 16 components.

4. Evaluation criteria and corrective action.

a. The results of the individual batch LCS are calculated in percent recovery or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation.

b. The individual LCS is compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits or utilize client specified assessment criteria.

c. A LCS that is determined to be within the criteria effectively establishes that the analytical system is in control and validates system performance for the samples in the associated batch. Samples analyzed along with a LCS determined to be "out of control" shall be considered suspect and the samples reprocessed and re-analyzed or the data reported with appropriate data qualifying codes.

5. If a large number of analytes are in the LCS, it becomes statistically likely that a few will be outside control limits. This may not indicate that the system is out of control, therefore corrective action may not be necessary. Upper and lower marginal exceedance (ME) limits can be established to determine when corrective action is necessary. A ME is defined as being beyond the LCS control limit (3 standard deviations), but within the ME limits. ME limits are between 3 and 4 standard deviations around the mean.

a. The number of allowable marginal exceedances is based on the number of analytes in the LCS. If more analytes exceed the LCS control limits than is allowed, or if any one analyte exceeds the ME limits, the LCS fails and corrective action is necessary. This marginal exceedance approach is relevant for methods with long lists of analytes. It will not apply to target analyte lists with fewer than 11 analytes.

b. The number of allowable marginal exceedances is as follows:

Number of analytes in LCS	Number of analytes allowed in ME of the LCS control limit
Greater than 90	Five
71-90	Four
51-70	Three
31-50	Two
11-30	One
Fewer than 11	None

c. Marginal exceedances shall be random. If the same analyte exceeds the LCS control limit repeatedly, it is an indication of a systemic problem. The source of the error shall be located and corrective action taken. Laboratories shall have a written procedure to monitor the application of marginal exceedance allowance to the LCS to ensure random behavior.

C. Sample specific controls - general.

1. The laboratory shall document procedures for determining the effect of the sample matrix on method performance. These procedures relate to the analyses of quality system matrix specific Quality Control (QC) samples and are designed as data quality indicators for a specific sample using the designated test method. These controls alone are not used to judge laboratory performance.

2. Examples of matrix specific QC include: Matrix Spike (MS); Matrix Spike Duplicate (MSD); sample duplicates; and surrogate spikes. The laboratory shall have procedures in place for tracking, managing, and handling matrix specific QC criteria including spiking appropriate components at appropriate concentrations, calculating recoveries and relative percent difference, evaluating and reporting results based on performance of the QC samples.

D. Sample specific controls - matrix spike and matrix spike duplicates.

1. Purpose. Matrix specific QC samples indicate the effect of the sample matrix on the precision and accuracy of the results generated using the selected method. The information from these controls is sample/matrix specific and would not normally be used to determine the validity of the entire batch.

2. Frequency. The frequency of the analysis of matrix specific samples shall be determined as part of a systematic planning process (e.g., Data Quality Objectives) or as specified by the test method.

3. Composition. The components to be spiked shall be as specified by the mandated test method. Any permit specified analytes, as specified by regulation or client requested analytes shall also be included. If there are no specified components, the laboratory shall spike per the following:

a. For those components that interfere with an accurate assessment such as spiking simultaneously with technical chlordane, toxaphene and PCBs, the spike should be chosen that represents the chemistries and elution patterns of the components to be reported.

b. For those test methods that have extremely long lists of analytes, a representative number may be chosen using the following criteria for choosing the number of analytes to be spiked. However, the laboratory shall insure that all targeted components are included in the spike mixture over a two-year period.

(1) For methods that include 1-10 targets, spike all components;

(2) For methods that include 11-20 targets, spike at least 10% 10 components or 80%, whichever is greater;

(3) For methods with more than 20 targets, spike at least 16 components.

4. Evaluation criteria and corrective action.

a. The results from matrix spike/matrix spike duplicate are primarily designed to assess the precision and accuracy of analytical results in a given matrix and are expressed as percent recovery (%R), relative percent difference (RPD), or other appropriate statistical technique that allows comparison to established acceptance criteria. The laboratory shall document the calculation for %R, RPD or other statistical treatment used.

b. The results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix spike results outside established criteria corrective action shall be documented or the data reported with appropriate data qualifying codes.

E. Sample specific controls - matrix duplicates.

1. Purpose. Matrix duplicates are defined as replicate aliquots of the same sample taken through the entire analytical procedure. The results from this analysis indicate the precision of the results for the specific sample using the selected method. The matrix duplicate provides a usable measure of precision only when target analytes are found in the sample chosen for duplication.

2. Frequency. The frequency of the analysis of matrix duplicates may be determined as part of a systematic planning process (e.g., Data Quality Objectives) or as specified by the mandated test method.

3. Composition. Matrix duplicates are performed on replicate aliquots of actual samples. The composition is usually not known.

4. Evaluation criteria and corrective action.

a. The results from matrix duplicates are primarily designed to assess the precision of analytical results in a given matrix and are expressed as relative percent difference (RPD) or another statistical treatment (e.g., absolute differences). The laboratory shall document the calculation for relative percent difference or other statistical treatments.

b. Results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory shall determine internal criteria and document the method used to establish the limits. For matrix duplicates results outside established criteria corrective action shall be documented or the data reported with appropriate data qualifying codes.

F. Sample specific controls - surrogate spikes.

1. Purpose. Surrogates are used most often in organic chromatography test methods and are chosen to reflect the chemistries of the targeted components of the method. Added prior to sample preparation/extraction, they provide a measure of recovery for every sample matrix.

2. Frequency. Except where the matrix precludes its use or when not commercially available, surrogate compounds shall be added to all samples, standards, and blanks for all appropriate test methods.

3. Composition. Surrogate compounds are chosen to represent the various chemistries of the target analytes in the method or [ MQO measurement quality objectives ]. They are often specified by the mandated method and are deliberately chosen for their being unlikely to occur as an environmental contaminant. Often this is accomplished by using deuterated analogs of select compounds.

4. Evaluation criteria and corrective action. The results are compared to the acceptance criteria as published in the mandated test method. Where there are no established criteria, the laboratory should determine internal criteria and document the method used to establish the limits. Surrogates outside the acceptance criteria shall be evaluated for the effect indicated for the individual sample results. Data quality objectives or other site-specific requirements may guide the appropriate corrective action. Results reported from analyses with surrogate recoveries outside the acceptance criteria should include appropriate data qualifiers.

1VAC30-45-771. Chemical testing: limit of detection and limit of quantitation.

A. General. All procedures used shall be documented. Documentation shall include the quality system matrix type. All supporting data shall be retained.

B. Limit of detection (LOD). The laboratory shall utilize a test method that provides an LOD that is appropriate and relevant for the intended use of the data. An LOD is not required for a test method when test results are not reported outside of the calibration range. LODs shall be determined by the protocol in the mandated test method or applicable regulation. If the protocol for determining LODs is not specified, the selection of the procedure shall reflect instrument limitations and the intended application of the test method.

1. The LOD shall be initially determined for the compounds of interest in each test method in a quality system matrix in which there are no target analytes or interferences at a concentration that would impact the results. Alternatively the LOD shall be determined in the quality system matrix of interest (see definition of matrix).

2. LODs shall be determined each time there is a change in the test method that affects how the test is performed, or when a change in instrumentation occurs that affects the sensitivity of the analysis.

3. The laboratory shall have established procedures to relate LOD with LOQ.

4. 3. The LOD shall be verified annually for each quality system matrix, method and analyte according to the procedure specified in 1VAC30-45-760 B 1.

C. Limit of quantitation (LOQ).

1. Any established LOQ shall be above the LOD.

2. The LOQ shall be verified annually for each quality system matrix, method and analyte according to the procedure specified in 1VAC30-45-760 B 2. Alternatively, the annual LOQ verification is not required if the LOD is reevaluated or verified according to subdivision B [ 4 3 ] of this section.

1VAC30-45-775. Chemical testing: constant and consistent test conditions.

A. The laboratory shall assure that the test instruments consistently operate within the specifications required of the application for which the equipment is used.

B. Glassware cleaning. Glassware shall be cleaned to meet the sensitivity of the test method.

C. B. Any cleaning and storage procedures that are not specified by the test method shall be documented in laboratory records and SOPs.

1VAC30-45-780. Toxicity testing: general. (Repealed.)

These standards apply to laboratories measuring the toxicity and/or bioaccumulation of contaminants in effluents (aquatic toxicity), receiving waters, sediments, elutriates, leachates and soils. In addition to the essential quality control standards set out in 1VAC30-45-781 through 1VAC30-45-788, some methods may have additional or other requirements based on factors such as the type of quality system matrix evaluated.

1VAC30-45-781. Toxicity testing: positive and negative controls. (Repealed.)

A. Positive control. Reference toxicant tests demonstrate a laboratory's ability to obtain consistent results with the test method and evaluate the overall health and sensitivity of test organisms over time.

1. The laboratory shall demonstrate its ability to obtain consistent results with standard reference toxicants (SRT) and complete an initial Demonstration of Capability (DOC) in order to attain accreditation in toxicity testing methods.

a. An initial DOC shall consist of five or more acceptable SRT tests for each test method, species and endpoint with different batches of organisms. Appropriate negative controls (water, sediment, or soil) shall be tested at the frequency and duration specified in the test method. Initial DOCs shall be prepared in accordance with the requirements of 1VAC30-45-730 F.

b. Initial DOC is established by maintenance of SRT test results on control charts. A laboratory shall record the control performance and statistical endpoints (such as NOEC or ECp) for each method species and endpoint on control charts. Initial DOC is established where 95% of the test results required in subdivision A 1 a of this section fall within the control limits established in accordance with subdivision A 1 c of this section and meet test acceptability criteria (TAC). The laboratory shall evaluate precision (i.e., coefficient of variation (CV)) or sensitivity (i.e., statistical minimum significant difference (SMSD) measures; see subdivision A 1 d of this section) for these tests against method-specific or, lacking the former, laboratory-derived criteria to determine validity of the initial DOC.

c. For endpoints that are point estimates (ICp, ECp), control charts are constructed by plotting the cumulative mean and the control limits that consist of the upper and lower 95% confidence limits (+/- 2 standard deviations). In case of highly variable point estimates that exceed method-specific criteria, the control chart limits are adjusted accordingly. For endpoints from hypothesis tests (NOEC, NOAEC), the values are plotted directly and the control limits consist of one concentration interval above and below the concentration representing the central tendency (i.e., the mode).

d. For endpoints that are point estimates, the cumulative mean CV is calculated and for endpoints from hypothesis tests, the SMSD is calculated. These values are maintained on a control chart.

2. Ongoing laboratory performance shall be demonstrated by routine SRT testing for each test method and species and endpoint in accordance with the minimum frequency requirements specified in subdivision A 3 of this section.

a. Intralaboratory precision is determined on an ongoing basis through the use of control charts as established in subdivision A 1 b of this section. The control charts shall be plotted as point estimate values, such as EC25 for chronic tests and LC50 for acute tests, or as appropriate hypothesis test values, such as the NOEC or NOAEC, over time within a laboratory.

b. After initial laboratory DOC is determined, the control limits and CV for an individual test method, endpoints and species shall be adjusted as additional test results are obtained. After 20 data points are collected for a test method and species, the control chart is maintained using only the last 20 data points, i.e., each successive mean value and control limit is calculated using only the last 20 values.

c. Control chart limits are expected to be exceeded occasionally regardless of how well a laboratory performs. Acceptance limits for point estimates (ICp, ECp) that are based on 95% confidence limits should theoretically be exceeded for one in 20 tests. Depending on the dilution factor and test sensitivity, control charts based on hypothesis test values (NOEC, NOAEC) may be expected to be exceeded on a similar frequency. Test results that fall outside of control chart limits at a frequency of 5.0% or less, or that fall just outside control chart limits (especially in the case of highly proficient laboratories that may develop relatively narrow acceptance limits over time), are not rejected de facto. Such data are evaluated in comparison with control chart characteristics including the width of the acceptance limits and the degree of departure of the value from acceptance limits.

d. Consistent with the test methods used, laboratories shall develop acceptance/rejection policies for SRT data that consider the source of test organisms, the direction of the deviation, test dilution factor, test sensitivity (for hypothesis test values), testing frequency, out-of-control test frequency, relative width of acceptance limits, inter-test CV, and degree of difference between test results and acceptance limits.

e. In the case of reference toxicant data that fails to meet control chart acceptance criteria, the test data are examined for defects, corrective action taken, and the test repeated if necessary, using a different batch of organisms or the data is qualified.

3. The frequency of ongoing laboratory reference toxicant testing shall be as follows unless the method specifically requires less frequent SRT tests (e.g., sediment tests):

a. For test methods conducted at a frequency of monthly or greater, SRT tests shall be conducted at an ongoing frequency of monthly.

b. For test methods and species commonly used in the laboratory, but that are tested at a frequency of less than monthly, SRT tests shall be conducted concurrently with the environmental test.

c. If the test organisms are obtained from an outside source the sensitivity of each batch of organisms received from a supplier shall be determined via a concurrent SRT test unless the supplier can provide control chart data for the last five SRT tests using the same SRT and test conditions. Supplied SRT data may not be older than six months.

d. The DOC for an analyst shall be consistent with 1VAC30-45-220 B but the frequency need not exceed the method-specified requirements and subdivision A 3 a and A 3 b of this section.

4. These standards do not currently specify a particular reference toxicant and dilution series. If the permitting authority identifies a reference toxicant or dilution series for a particular test, the laboratory shall follow the specified requirements. All reference toxicant tests conducted for a given test method and species shall use the same reference toxicant, test concentrations, dilution water and data analysis methods. A dilution factor of 0.5x or greater shall be used for both acute and chronic tests.

5. The reference toxicant tests shall be conducted following the same procedures as the environmental toxicity tests for which the precision is being evaluated, unless otherwise specified in the test method (for example, 10-day sediment tests employ 96-h water-only reference toxicant tests). The test duration, laboratory dilution water, feeding, organism age, range and density, test volumes, renewal frequency, water quality measurements, and the number of test concentrations, replicates and organisms per replicate shall be the same as specified for the environmental toxicity test.

B. Negative control: control, brine control, control sediment, control soil or dilution water.

1. The standards for the use, type and frequency of testing of negative controls are specified by the test methods and by permit or regulation and shall be followed. A negative control is included with each test to evaluate test performance and the health and sensitivity of the specific batch of organisms.

2. Appropriate additional negative controls shall be included when sample adjustments (for example, addition of thiosulfate for dechlorination) or solvent carriers are used in the test.

3. Test acceptability criteria (TAC). The test acceptability criteria specified in the test method shall be achieved for both the reference toxicant and the effluent or environmental sample toxicity test. The criteria shall be calculated and shall meet the method specified requirements for performing toxicity tests.

1VAC30-45-782. Toxicity testing: variability and/or reproducibility. (Repealed.)

Intralaboratory precision shall be determined on an ongoing basis through the use of further reference toxicant tests and related control charts as described in 1VAC30-45-840 A.

1VAC30-45-783. Toxicity testing: accuracy. (Repealed.)

This principle is not applicable to toxicity testing.

1VAC30-45-784. Toxicity testing: test sensitivity. (Repealed.)

A. The statistical minimum significant difference (SMSD) shall be calculated according to the formula specified by the test method and reported with the test results.

B. Point estimates: (LCp, ICp, or ECp) Confidence intervals shall be reported as a measure of the precision around the point estimate value, when the calculation is possible.

C. The SMSD shall be calculated and reported for only hypothesis test values, such as the NOEC or NOAEC.

1VAC30-45-785. Toxicity testing: selection of appropriate statistical analysis methods. (Repealed.)

A. If required, methods of data analysis and endpoints are specified by language in the regulation, permit or the test method.

B. Dose response curves. The data shall be plotted in the form of a curve relating the dose of the chemical or concentration of sample to cumulative percentage of test organisms demonstrating a response such as death. Evaluation criteria shall be established for interpretation of concentration or dose response curves.

1VAC30-45-786. Toxicity testing: selection and use of reagents and standards. (Repealed.)

A. The grade of all reagents used in toxicity tests is specified in the test method except the reference standard. All reference standards shall be prepared from chemicals that are analytical reagent grade or better. The preparation of all standards and reference toxicants shall be documented.

B. All standards and reagents associated with chemical measurements, such as dissolved oxygen, pH or specific conductance, shall comply with the standards outlined in 1VAC30-45-740 D 1 d.

C. Only reagent-grade water collected from distillation or deionization units is used to prepare reagents.

1VAC30-45-787. Toxicity testing: selectivity. (Repealed.)

The permit or regulation specifies the selectivity of the test.

1VAC30-45-788. Toxicity testing: constant and consistent test conditions. (Repealed.)

A. If closed refrigerator-sized incubators are used, culturing and testing of organisms shall be separated to avoid cross-contamination.

B. Laboratory space shall be adequate for the types and numbers of tests performed. The building shall provide adequate cooling, heating and illumination for conducting testing and culturing; hot and cold running water shall be available for cleaning equipment.

C. Air used for aeration of test solutions, dilution waters and cultures shall be free of oil and fumes.

D. The laboratory or a contracted outside expert shall positively identify test organisms to species on an annual basis. The taxonomic reference (citation and page(s)) and the names(s) of the taxonomic expert(s) shall be kept on file at the laboratory. When organisms are obtained from an outside source, the supplier shall provide this same information.

E. Instruments used for routine support measurements of chemical and physical parameters such as pH, DO, conductivity, salinity, alkalinity, hardness, chlorine, ammonia, and weight shall be calibrated, and/or standardized per manufacturer's instructions. As these are support measurements, only the calibration and verification requirements specified at 1VAC30-45-740 D 1 apply. All measurements and calibrations shall be documented.

F. Test temperature shall be maintained as specified for the test method. Temperature control equipment shall be adequate to maintain the required test temperature(s). The average daily temperature of the test solutions shall be maintained within the method-specified range. The minimum frequency of measurement shall be once per 24-hour period. The test temperature for continuous-flow toxicity tests shall be recorded and monitored continuously. Where electronic data loggers are used, temperature shall be monitored at a frequency sufficient to capture temporal variations of the environmental control system.

G. Reagent-grade water, prepared by any combination of distillation, reverse osmosis, ion exchange, activated carbon and particle filtration, shall meet the method specified requirements.

H. The quality of the standard dilution water used for testing or culturing shall be sufficient to allow satisfactory survival, growth and reproduction of the test species as demonstrated by routine reference toxicant tests and negative control performance. Water used for culturing and testing shall be analyzed for toxic metals and organics whenever the minimum acceptability criteria for control survival, growth or reproduction are not met and no other cause, such as contaminated glassware or poor stock, can be identified. It is recognized that the analyte lists of some methods manuals may not include all potential toxicants, are based on estimates of chemical toxicity available at the time of publication and may specify detection limits that are not achievable in all matrices. However, for those analytes not listed, or for which the measured concentration or limit of detection is greater than the method-specified limit, the laboratory shall demonstrate that the analyte at the measured concentration or reported limit of detection does not exceed one-tenth of the expected chronic value for the most sensitive species tested and/or cultured. The expected chronic value is based on professional judgment and the best available scientific data. The "USEPA Ambient Water Quality Criteria Documents" and the EPA AQUIRE database provide guidance and data on acceptability and toxicity of individual metals and organic compounds.

I. The quality of the food used for testing or culturing shall be sufficient to allow satisfactory survival, growth and reproduction of the test species as demonstrated by routine reference toxicant tests and negative control performance. The laboratory shall have written procedures for the evaluation of food acceptance.

J. A subset of organisms used in bioaccumulation tests shall be analyzed at the start of the test (baseline) for the target compounds to be measured in the bioaccumulation tests.

K. Test chamber size and test solution volume shall be as specified in the test method. All test chambers used in a test shall be identical.

L. Test organisms shall be fed the quantity and type food or nutrients specified in the test method. They shall also be fed at the intervals specified in the test methods.

M. All organisms in a test shall be from the same source. Where available certified seeds are used for soil tests.

N. All organisms used in tests, or used as broodstock to produce neonate test organisms (for example cladocerans and larval fish), shall appear healthy, show no signs of stress or disease and exhibit acceptable survival (90% or greater) during the 24-hour period immediately preceding use in tests.

O. All materials used for test chambers, culture tanks, tubing, etc., and coming in contact with test samples, solutions, control water, sediment or soil or food shall be nontoxic and cleaned as described in the test methods. Materials shall not reduce or add to sample toxicity. Appropriate materials for use in toxicity testing and culturing are described in the referenced manuals.

P. Light intensity shall be maintained as specified in the methods manuals. Measurements shall be made and recorded on a yearly basis. Photoperiod shall be maintained as specified in the test methods and shall be documented at least quarterly. For algal and plant tests, the light intensity shall be measured and recorded at the start of each test.

Q. The testing laboratory shall document the health and culturing conditions of all organisms used for testing. Such documentation shall include culture conditions (e.g., salinity, hardness, temperature, pH) and observations of any stress, disease or mortality. When organisms are obtained from an outside source, the laboratory shall obtain written documentation of these water quality parameters and biological observations for each lot of organism received. These observations shall adequately address the 24-hour time period referenced in subsection N of this section. The laboratory shall also record each of these observations and water quality parameters upon the arrival of the organisms at the testing laboratory.

R. Age and the age range of the test organisms shall be as specified in the test method. Supporting information, such as hatch dates and times, times of brood releases and metrics (for example, chironomid head capsule width) shall be documented.

S. The maximum holding time of effluents (elapsed time from sample collection to first use in a test) shall not exceed 36 hours; samples may be used for renewal up to 72 hours after first use except as prescribed by the method and approved by the regulatory agency having authority for program oversight.

T. All samples shall be chilled to 0 to 6°C during or immediately after collection except as prescribed by the method.

U. Organisms used in a given test shall be from the same batch.

V. All tests shall have the minimum number of replicates per treatment as prescribed by the method.

W. The control population of Ceriodaphnia in chronic effluent or receiving water tests shall contain no more than 20% males.

X. The culturing of C. dubia shall be adequate such that blocking by parentage can be established.

Y. Dissolved oxygen and pH in aquatic tests shall be within acceptable range at test initiation and aeration (minimal) is provided to tests if, and only if, acceptable dissolved oxygen concentrations cannot be otherwise maintained or if specified by the test method.

Z. Test soils or sediments shall be within the geochemical tolerance range of the test organism.

AA. An individual test may be conditionally acceptable if temperature, dissolved oxygen, pH and other specified conditions fall outside specifications, depending on the degree of the departure and the objectives of the tests (see test conditions and test acceptability criteria specified for each test method).

1VAC30-45-791. Microbiology testing: sterility checks and blanks, positive and negative controls.

A. Sterility checks and blanks. The laboratory shall demonstrate that the filtration equipment and filters, sample containers, media and reagents have not been contaminated through improper handling or preparation, inadequate sterilization, or environmental exposure.

1. A sterility blank shall be analyzed for each lot of pre-prepared, ready-to-use medium (including chromofluorogenic reagent) and for each batch of medium prepared in the laboratory. This shall be done prior to first use of the medium.

2. For filtration technique, the laboratory shall conduct one beginning and one ending sterility check for each laboratory sterilized filtration unit used in a filtration series. The filtration series may include single or multiple filtration units, which have been sterilized prior to beginning the series. For presterilized single use funnels a sterility check shall be performed on one funnel per lot. The filtration series is considered ended when more than 30 minutes elapses between successive filtrations. During a filtration series, filter funnels shall be rinsed with three 20-30 ml portions of sterile rinse water after each sample filtration. In addition, laboratories shall insert a sterility blank after every 10 samples or sanitize filtration units by UV light after each sample filtration.

3. For pour plate technique, sterility blanks of the medium shall be made by pouring, at a minimum, one uninoculated plate for each lot of pre-prepared, ready-to-use media and for each batch of medium prepared in the laboratory.

4. Sterility checks on sample containers shall be performed on at least one container for each lot of purchased, presterilized containers with nonselective growth media. For containers prepared and sterilized in the laboratory, a sterility check shall be performed on one container per sterilized batch with nonselective growth media.

5. A sterility blank shall be performed on each batch of dilution water prepared in the laboratory and on each batch of pre-prepared, ready-to-use dilution water with nonselective growth media.

6. At least one filter from each new lot of membrane filters shall be checked for sterility with nonselective growth media.

B. Positive controls.

1. Positive culture controls demonstrate that the medium can support the growth of the target [ organism(s) organism ], and that the medium produces the specified or expected reaction to the target [ organism(s) organism ].

2. Each preprepared, ready-to-use lot of medium (including chromofluorogenic reagent) and each batch of medium prepared in the laboratory shall be tested and demonstrate a known positive response. This shall be done prior to first use of the medium.

C. Negative controls. The provisions of this subsection shall not apply to wastewater treatment plants.

1. Negative culture controls demonstrate that the medium does not support the growth of [ non-target nontarget ] organisms or does not demonstrate the typical positive reaction of the target organism(s) organism or organisms.

2. Each pre-prepared, ready-to-use lot of selective medium (including chromofluorogenic reagent) and each batch of selective medium prepared in the laboratory shall be analyzed with one or more known negative culture controls, (i.e., nontarget organisms,) as appropriate to the method. This shall be done prior to first use of the medium.

1VAC30-45-796. Microbiology testing: quality of standards, reagents, and media.

A. The laboratory shall ensure that the quality of the reagents and media used is appropriate for the test concerned.

B. Culture media may be prepared from commercial dehydrated powders or may be purchased ready to use. The laboratory may prepare media from basic ingredients when commercial media are not available or when it can be demonstrated that commercial media do not provide adequate results. Media prepared by the laboratory from basic ingredients shall be tested for performance (e.g., for selectivity, sensitivity, sterility, growth promotion, growth inhibition) prior to first use. Detailed testing criteria information shall be defined in either the laboratory's test methods, SOPs, quality manual, or similar documentation.

C. Reagents, commercial dehydrated powders and media shall be used within the shelf-life of the product and shall be documented according to 1VAC30-45-730 J.

D. Distilled water, deionized water or reverse osmosis produced water free from bactericidal and inhibitory substances shall be used in the preparation of media, solutions and buffers. The quality of the water shall be monitored for chlorine residual, specific conductance, and heterotrophic bacteria plate count monthly (when in use), when maintenance is performed on the water treatment system, or at startup after a period of disuse longer than one month.

E. Analysis for metals and the Bacteriological Water Quality Test (to determine presence of toxic agents or growth promoting substances) shall be performed annually. Results of these analyses shall meet the specifications of the required method and records of analyses shall be maintained for three years. (An exception to performing the Bacteriological Water Quality Test shall be given to laboratories that can supply documentation to show that their water source meets the criteria, as specified by the method, for Type I or Type II reagent water.)

F. Media, solutions and reagents shall be prepared, used and stored according to a documented procedure following the manufacturer's instructions or the test method. Documentation for media prepared in the laboratory shall include date of preparation, preparer's initials, type and amount of media prepared, manufacturer and lot number, final pH of the media, and expiration date. Documentation for media purchased pre-prepared, ready to use shall include manufacturer, lot number, type and amount of media received, date of receipt, expiration date of the media, and pH of the media.

1VAC30-45-798. Microbiology testing: constant and consistent test conditions.

A. Laboratory facilities. Floors and work surfaces shall be nonabsorbent and easy to clean and disinfect. Work surfaces shall be adequately sealed. Laboratories shall provide sufficient storage space, and shall be clean and free from dust accumulation. Plants, food, and drink shall be prohibited from the laboratory work area.

B. Laboratory equipment.

1. Temperature measuring devices. Temperature measuring devices such as liquid-in-glass thermometers, thermocouples, and platinum resistance thermometers used in incubators, autoclaves and other equipment shall be the appropriate quality to meet specification(s) specifications in the test method. The graduation of the temperature measuring devices shall be appropriate for the required accuracy of measurement and they shall be calibrated to national or international standards for temperature (see 1VAC30-45-740 C). Calibration shall be done at least annually.

2. Autoclaves.

a. The performance of each autoclave shall be initially evaluated by establishing its functional properties and performance, for example, heat distribution characteristics with respect to typical uses. Autoclaves shall meet specified temperature tolerances. Pressure cookers shall not be used for sterilization of growth media.

b. Demonstration of sterilization temperature shall be provided by use of continuous temperature recording device or by use of a maximum registering thermometer with every cycle. Appropriate biological indicators shall be used once per month to determine effective sterilization. Temperature sensitive tape shall be used with the contents of each autoclave run to indicate that the autoclave contents have been processed.

c. Records of autoclave operations shall be maintained for every cycle. Records shall include date, contents, maximum temperature reached, pressure, time in sterilization mode, total run time (may be recorded as time in and time out) and analyst's initials.

d. Autoclave maintenance shall be performed annually, either internally or by service contract, shall be performed annually and shall include a pressure check and calibration of temperature device. Records of the maintenance shall be maintained in equipment logs. If the laboratory demonstrates regular monitoring of pressure (e.g., for each autoclaved batch) and annual calibration of the maximum registering thermometer, the annual autoclave pressure and temperature device checks shall not be required.

e. The autoclave mechanical timing device shall be checked quarterly against a stopwatch and the actual time elapsed documented.

3. Volumetric equipment. Volumetric equipment shall be calibrated as follows:

a. Equipment with movable parts such as automatic dispensers, dispensers/diluters, and mechanical hand pipettes shall be verified for accuracy quarterly.

b. Equipment such as filter funnels, bottles, nonclass A glassware, and other marked containers shall be calibrated once per lot prior to first use.

c. The volume of the disposable volumetric equipment such as sample bottles and disposable pipettes shall be checked once per lot.

4. UV instruments. UV instruments used for sanitization shall be tested quarterly for effectiveness with an appropriate UV light meter or by plate count agar spread plates. Replace bulbs if output is less than 70% of original for light tests or if count reduction is less than 99% for a plate containing 200 to 300 organisms.

5. Conductivity meters, oxygen meters, pH meters, hygrometers, and other similar measurement instruments shall be calibrated according to the method specified requirements (see 1VAC30-45-740 D 1 d).

6. Incubators, water baths, and ovens.

a. The stability and uniformity of temperature distribution and time required after test sample addition to reestablish equilibrium conditions in incubators and water baths shall be established. Temperature of incubators and water baths shall be documented twice daily, at least four hours apart, on each day of use.

b. Ovens used for sterilization shall be checked for sterilization effectiveness monthly with appropriate biological indicators. Records shall be maintained for each cycle that include date, cycle time, temperature, contents and analyst's initials.

7. Labware (glassware and plasticware).

a. The laboratory shall have a documented procedure for washing labware, if applicable. Detergents designed for laboratory use shall be used.

b. Glassware shall be made of borosilicate or other noncorrosive material, free of chips and cracks, and shall have readable measurement marks.

c. Labware that is washed and reused shall be tested for possible presence of residues that may inhibit or promote growth of microorganisms by performing the Inhibitory Residue Test annually, and each time the lab changes the lot of detergent or washing procedures.

d. Washed labware shall be tested at least once daily, each day of washing, for possible acid or alkaline residue by testing at least one piece of labware with a suitable pH indicator such as bromothymol blue. Records of tests shall be maintained.

1VAC30-45-800. Radiochemical testing: general. (Repealed.)

These standards apply to laboratories undertaking the examination of environmental samples by radiochemical analysis. These procedures for radiochemical analysis may involve some form of chemical separation followed by detection of the radioactive decay of analyte (or indicative daughters) and tracer isotopes where used. For the purpose of these standards, procedures for the determination of radioactive isotopes by mass spectrometry (e.g., ICP-MS or TIMS) or optical (e.g., KPA) techniques are not addressed herein.

1VAC30-45-801. Radiochemical testing: negative and positive controls. (Repealed.)

A. Negative controls.

1. Method blank shall be performed at a frequency of one per preparation batch. The results of this analysis shall be one of the quality control measures to be used to assess the batch. The method blank result shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified method blank acceptance criteria is not met, the specified corrective action and contingencies shall be followed and results reported with appropriate data qualifying codes. The occurrence of a failed method blank acceptance criteria and the actions taken shall be noted in the laboratory report.

2. In the case of gamma spectrometry, generally a nondestructive analysis, a method blank shall be prepared using a calibrated counting geometry similar to that used for the samples. The container of the appropriate geometry can be empty or filled to similar volume to partially simulate gamma attenuation due to a sample matrix.

3. There shall be no subtraction of the required method blank result from the sample results in the associated preparation or analytical batch unless permitted by method or program. This does not preclude the application of any correction factor (e.g., instrument background, analyte presence in tracer, reagent impurities, peak overlap, etc.) to all analyzed samples, both program/project submitted and internal quality control samples. However, these correction factors shall not depend on the required method blank result in the associated analytical batch.

4. The method blank sample shall be prepared with similar aliquot size to that of the routine samples for analysis and the method blank result and acceptance criteria shall be calculated in a manner that compensates for sample results based upon differing aliquot size.

B. Positive controls.

1. Laboratory control samples shall be performed at a frequency of one per preparation batch. The results of this analysis shall be one of the quality control measures to be used to assess the batch. The laboratory control sample result shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified laboratory control sample acceptance criteria is not met the specified corrective action and contingencies shall be followed. The occurrence of a failed laboratory control sample acceptance criteria and the actions taken shall be noted in the laboratory report.

2. Matrix spike shall be performed at a frequency of one per preparation batch for those methods that include a chemical separation process without the use of an internal standard or carrier, and where there is sufficient sample to do so. Although gross alpha, gross beta and tritium measurements do not involve a chemical separation process, matrix spikes shall be performed for these analyses on aqueous samples. The results of this analysis shall be one of the quality control measures to be used to assess the batch. The matrix spike result shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified matrix spike acceptance criteria is not met, the specified corrective action and contingencies shall be followed. The occurrence of a failed matrix spike acceptance criteria and the actions taken shall be noted in the laboratory report. The lack of sufficient sample aliquot size to perform a matrix spike shall be noted in the laboratory report.

3. The activity of the laboratory control sample shall (i) be at least five times the limit of detection and (ii) at a level comparable to that of routine samples when such information is available if the sample activities are expected to exceed five times the limit of detection.

4. The activity of the matrix spike analytes(s) shall be greater than five times the limit of detection.

5. The laboratory standards used to prepare the laboratory control sample and matrix spike shall be from a source independent of the laboratory standards used for instrument calibration and shall meet the requirements for reference standards provided in 1VAC30-45-807 A.

6. The matrix spike shall be prepared by adding a known activity of target analyte after subsampling if required but before any chemical treatment (e.g., chemical digestion, dissolution, separation, etc.). Where a radiochemical method, other than gamma spectroscopy, has more than one reportable analyte isotope (e.g., plutonium, Pu 238 and Pu 239, using alpha spectrometry), only one of the analyte isotopes need be included in the laboratory control or matrix spike sample at the indicated activity level. However, where more than one analyte isotope is present above the specified limit of detection, each shall be assessed against the specified acceptance criteria.

7. Where gamma spectrometry is used to identify and quantitate more than one analyte isotope, the laboratory control sample shall contain isotopes that represent the low (e.g., americium-241), medium (e.g., cesium-137) and high (e.g., cobalt-60) energy range of the analyzed gamma spectra. As indicated by these examples the isotopes need not exactly bracket the calibrated energy range or the range over which isotopes are identified and quantitated.

8. The laboratory control sample shall be prepared with similar aliquot size to that of the routine samples for analyses.

C. Other controls.

1. Tracer. For those methods that utilize a tracer (i.e., internal standard) each sample result shall have an associated tracer recovery calculated and reported. The tracer shall be added to the sample after subsampling if required but before any chemical treatment (e.g., chemical digestion, dissolution, separation, etc.) unless otherwise specified by the method. The tracer recovery for each sample result shall be one of the quality control measures to be used to assess the associated sample result acceptance. The tracer recovery shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified tracer recovery acceptance criteria is not met the specified corrective action and contingencies shall be followed. The occurrence of a failed tracer recovery acceptance criteria and the actions taken shall be noted in the laboratory report.

2. Carrier. For those methods that utilize a carrier for recovery determination, each sample shall have an associated carrier recovery calculated and reported. The carrier shall be added to the sample after subsampling if required but before any chemical treatment (e.g., chemical digestion, dissolution, separation, etc.) unless otherwise specified by the method. The carrier recovery for each sample shall be one of the quality control measures to be used to assess the associated sample result acceptance. The carrier recovery shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified carrier recovery acceptance criteria is not met the specified corrective action and contingencies shall be followed. The occurrence of a failed carrier recovery acceptance criteria and the actions taken shall be noted in the laboratory report.

1VAC30-45-802. Radiochemical testing: analytical variability/reproducibility. (Repealed.)

A. Replicate shall be performed at a frequency of one per preparation batch where there is sufficient sample to do so. The results of this analysis shall be one of the quality control measures to be used to assess batch acceptance. The replicate result shall be assessed against the specific acceptance criteria specified in the laboratory method manual. When the specified replicate acceptance criteria is not met the specified corrective action and contingencies shall be followed. The occurrence of a failed replicate acceptance criteria and the actions taken shall be noted in the laboratory report.

B. For low level samples (less than approximately three times the limit of detection) the laboratory may analyze duplicate laboratory control samples or a replicate matrix spike (matrix spike and a matrix spike duplicate) to determine reproducibility within a preparation batch.

1VAC30-45-803. Radiochemical testing: method evaluation. (Repealed.)

In order to ensure the accuracy of the reported result, the following procedures shall be in place:

1. Initial demonstration of capability shall be performed initially (prior to the analysis of any samples) and with a significant change in instrument type (e.g., different detection technique), personnel or method.

2. Proficiency test samples. The laboratory shall use the results of such analysis to evaluate its ability to produce accurate data.

1VAC30-45-804. Radiochemical testing: radiation measurement instrumentation. (Repealed.)

A. General. Because of the stability and response nature of modern radiation measurement instrumentation, it is not typically necessary to verify calibrate these systems each day of use. However, verification of calibration is required as outlined in subsection B of this section. This section addresses those practices that are necessary for proper calibration and those requirements of 1VAC30-45-740 D (instrument calibrations) that are not applicable to some types of radiation measurement instrumentation.

B. Instrument calibration.

1. Given that activity detection efficiency is independent of sample activity at all but extreme activity levels, the requirements of 1VAC30-45-740 D 2 b (7) are not applicable to radiochemical method calibrations except mass attenuation in gas-proportional counting and sample quench in liquid scintillation counting. Radiation measurement instruments are subject to calibration prior to initial use, when the instrument is placed back in service after malfunctioning and the instrument's response has changed as determined by a performance check or when the instrument's response exceeds predetermined acceptance criteria for the instrument quality control.

2. Instrument calibration shall be performed with reference standards as defined in 1VAC30-45-807 A. The standards shall have the same general characteristics (i.e., geometry, homogeneity, density, etc.) as the associated samples.

3. The frequency of calibration shall be addressed in the laboratory method manual if not specified in the method. A specific frequency (e.g., monthly) or observations from the associated control or tolerance chart, as the basis for calibration shall be specified.

C. Continuing instrument calibration verification (performance checks). Performance checks shall be performed using appropriate check sources and monitored with control charts or tolerance charts to ensure that the instrument is operating properly and that the detector response has not significantly changed and, therefore, the instrument calibration has not changed. The same check source used in the preparation of the tolerance chart or control chart at the time of calibration shall be used in the calibration verification of the instrument. The check sources shall provide adequate counting statistics for a relatively short count time and the source should be sealed or encapsulated to prevent loss of activity and contamination of the instrument and laboratory personnel.

1. For gamma spectroscopy systems, the performance checks for efficiency and energy calibration shall be performed on a day-of-use basis along with performance checks on peak resolution.

2. For alpha spectroscopy systems, the performance check for energy calibration shall be performed on a weekly basis and the performance check for counting efficiency shall be performed on at least a monthly basis.

3. For gas-proportional and liquid scintillation counters, the performance check for counting efficiency shall be performed on a day-of-use basis. For batches of samples that uninterruptedly count for more than a day a performance check can be performed at the beginning and end of the batch as long as this time interval is no greater than one week. Verification of instrument calibration does not directly verify secondary calibrations, e.g., the mass efficiency curve or the quench curve.

4. For scintillation counters the calibration verification for counting efficiency shall be performed on a day of use basis.

D. Background measurement. Background measurements shall be made on a regular basis and monitored using control charts or tolerance charts to ensure that a laboratory maintains its capability to meet required data quality objectives. These values may be subtracted from the total measured activity in the determination of the sample activity.

1. For gamma spectroscopy systems, background measurements shall be performed on at least a monthly basis.

2. For alpha spectroscopy systems, background measurements shall be performed on at least a monthly basis.

3. For gas-proportional counters, background measurements shall be performed on at least on a weekly basis.

4. For scintillation counters, background measurements shall be performed each day of use.

E. Instrument contamination monitoring. The laboratory shall have a written procedure for monitoring radiation measurement instrumentation for radioactive contamination. The procedure shall indicate the frequency of the monitoring and shall indicate criteria, which initiates corrective action.

1VAC30-45-805. Radiochemical testing: Minimum detectable activity (MDA)/Minimum detectable concentration (MDC)/Lower level of detection (LLD). (Repealed.)

A. MDA/MDC/LLD shall be determined prior to sample analysis and shall be redetermined each time there is a significant change in the test method or instrument type.

B. The procedures employed shall be documented and consistent with mandated method or regulation.

1VAC30-45-806. Radiochemical testing: data reduction. (Repealed.)

A. The requirements of 1VAC30-45-730 K apply.

B. Measurement uncertainties. Each result shall be reported with the associated measurement uncertainty. The procedures for determining the measurement uncertainty shall be documented and be consistent with mandated method and regulation.

1VAC30-45-807. Radiochemical testing: quality of standards and reagents. (Repealed.)

A. The quality control program shall establish and maintain provisions for radionuclide standards.

1. Reference standards that are used in a radiochemical laboratory shall be obtained from the National Institute of Standards and Technology (NIST), or suppliers who participate in supplying NIST standards or NIST traceable radionuclides. Any reference standards purchased outside the United States shall be traceable back to each country's national standards laboratory. Commercial suppliers of reference standards shall conform to ANSI N42.22 to assure the quality of their products.

2. Reference standards shall be accompanied with a certificate of calibration whose content is as described in ANSI N42.22 - 1995, Section 8, Certificates.

3. Laboratories should consult with the supplier if the laboratory's verification of the activity of the reference traceable standard indicates a noticeable deviation from the certified value. The laboratory shall not use a value other than the decay corrected certified value. The laboratory shall have a written procedure for handling, storing and establishment of expiration dates for reference standards.

B. All reagents used shall be analytical reagent grade or better.

1VAC30-45-808. Radiochemical testing: constant and consistent test conditions. (Repealed.)

The laboratory shall maintain a radiological control program that addresses analytical radiological control. The program shall address the procedures for segregating samples with potentially widely varying levels of radioactivity. The radiological control program shall explicitly define how low level and high level samples will be identified, segregated and processed in order to prevent sample cross-contamination. The radiological control program shall include the measures taken to monitor and evaluate background activity or contamination on an ongoing basis.

1VAC30-45-811. Air testing: negative and positive controls.

A. Negative controls.

1. Method blanks shall be performed at a frequency of at least one per batch of 20 environmental samples or less per sample preparation method. The results of the method blank analysis shall be used to evaluate the contribution of the laboratory provided sampling media and analytical sample preparation procedures to the amount of analyte found in each sample. If the method blank result is greater than the limit of quantitation and contributes greater than 10% of the total amount of analyte found in the sample, the source of the contamination shall be investigated and measures taken to eliminate the source of contamination. If contamination is found, the data shall be qualified in the report.

2. Collection efficiency. Sampling trains consisting of multiple sections (e.g., filters, sorbent tubes, impingers) that are received intact by the laboratory shall be separated into "front" and "back" sections if required by the client. Each section shall be processed and analyzed separately and the analytical results reported separately.

B. Positive controls. Laboratory control sample (LCS) shall be analyzed at a rate of at least one per batch of 20 or fewer samples per sample preparation method for each analyte. If a spiking solution is not available, a calibration solution whose concentration approximates that of the samples shall be included in each batch and with each lot of media. If a calibration solution must be used for the LCS, the client will be notified prior to the start of analysis. The concentration of the LCS shall be relevant to the intended use of the data and either at a regulatory limit or below it.

C. Surrogates shall be used as required by the test method.

D. Matrix spike shall be used as required by the test method.

1VAC30-45-820. Asbestos testing: general. (Repealed.)

These standards apply to laboratories undertaking the examination of asbestos samples. These standards are organized by analytical technique, including transmission electron microscopy (TEM) for the analysis of water, wastewater, air, and bulk samples; phase contrast microscopy (PCM) for analysis of workplace air; and polarized light microscopy (PLM) for analysis of bulk samples. These procedures for asbestos analysis involve sample preparation followed by detection of asbestos. If NIST SRMs specified below are unavailable, the laboratory may substitute an equivalent reference material with a certificate of analysis.

1VAC30-45-821. Asbestos testing: negative controls. (Repealed.)

A. Transmission electron microscopy.

1. Water and wastewater.

a. Blank determinations shall be made prior to sample collection. When using polyethylene bottles, one bottle from each batch, or a minimum of one from each 24 shall be tested for background level. When using glass bottles, four bottles from each 24 shall be tested. An acceptable bottle blank level is defined as =0.01 MFL > 10 µm. (EPA/600/R-94/134, Method 100.2, Section 8.2)

b. A process blank sample consisting of fiber-free water shall be run before the first field sample. The quantity of water shall be =10 mL for a 25-mm diameter filter and = 50 mL for a 47-mm diameter filter. (EPA/600/R-94/134, Method 100.2, Section 11.8)

2. Air.

a. A blank filter shall be prepared with each set of samples. A blank filter shall be left uncovered during preparation of the sample set and a wedge from that blank filter shall be prepared alongside wedges from the sample filters. At minimum, the blank filter shall be analyzed for each 20 samples analyzed. (40 CFR Part 763, Appendix A to Subpart E (AHERA), Table 1)

b. Maximum contamination on a single blank filter shall be no more than 53 structures/mm². Maximum average contamination for all blank filters shall be no more than 18 structures/mm². (AHERA, III.F.2)

3. Bulk samples.

a. Contamination checks using asbestos-free material, such as the glass fiber blank in SRM 1866 (Page C-3, NIST Handbook 150-3, August 1994) shall be performed at a frequency of one for every 20 samples analyzed. The detection of asbestos at a concentration exceeding 0.1% will require an investigation to detect and remove the source of the asbestos contamination.

b. The laboratory shall maintain a list of nonasbestos fibers that can be confused with asbestos (Section 7.5, Page C-8, NIST Handbook 150-3, August 1994). The list shall include crystallographic and/or chemical properties that disqualify each fiber being identified as asbestos (Section 2.5.5.2.1 Identification, Page 54, EPA/600/R-93/116).

c. The laboratory should have a set of reference asbestos materials from which a set of reference diffraction and X-ray spectra have been developed.

B. Phase contrast microscopy. At least two field blanks (or 10% of the total samples, whichever is greater) shall be submitted for analysis with each set of samples. Field blanks shall be handled in a manner representative of actual handling of associated samples in the set with a single exception that air shall not be drawn through the blank sample. A blank cassette shall be opened for approximately 30 seconds at the same time other cassettes are opened just prior to analysis. Results from field blank samples shall be used in the calculation to determine final airborne fiber concentration. The identity of blank filters should be unknown to the counter until all counts have been completed. If a field blank yields greater than seven fibers per 100 graticule fields, report possible contamination of the samples.

C. Polarized light microscopy.

1. Friable materials. At least one blank slide shall be prepared daily or with every 50 samples analyzed, whichever is less. This is prepared by mounting a subsample of an isotropic verified non-ACM (e.g., fiberglass in SRM 1866) in a drop of immersion oil (n_D should reflect usage of various n_D's) on a clean slide, rubbing preparation tools (forceps, dissecting needles, etc.) in the mount and placing a clean coverslip on the drop. The entire area under the coverslip shall be scanned to detect any asbestos contamination. A similar check shall be made after every 20 uses of each piece of homogenization equipment. An isotropic verified non-ACM shall be homogenized in the clean equipment, a slide prepared with the material and the slide scanned for asbestos contamination. (This can be substituted for the blank slide mentioned in this section.)

2. Nonfriable materials. At least one non-ACM nonfriable material shall be prepared and analyzed with every 20 samples analyzed. This non-ACM shall go through the full preparation and analysis regimen for the type of analysis being performed.

1VAC30-45-822. Asbestos testing: test variability/reproducibility. (Repealed.)

A. Transmission electron microscopy. Quality assurance analyses shall be performed regularly covering all time periods, instruments, tasks, and personnel. The selection of samples shall be random and samples of special interest may be included in the selection of samples for quality assurance analyses. When possible, the checks on personnel performance shall be executed without their prior knowledge. A disproportionate number of analyses shall not be performed prior to internal or external audits. It is recommended that a laboratory initially be at 100% quality control (all samples reanalyzed). The proportion of quality control samples can later be lowered gradually, as control indicates, to a minimum of 10%.

1. Water and wastewater. All analyses shall be performed on relocator grids so that other laboratories can easily repeat analyses on the same grid openings. Quality assurance analyses shall not be postponed during periods of heavy workloads. The total number of QA samples and blanks shall be greater than or equal to 10% of the total sample workload. Precision of analyses is related to concentration, as gleaned from interlaboratory proficiency testing. Relative standard deviations (RSD) for amphibole asbestos decreased from 50% at 0.8 MFL to 25% at 7 MFL in interlaboratory proficiency testing, while RSD for chrysotile was higher, 50% at 6 MFL.

a. Replicate. A second, independent analysis shall be performed on the same grids but on different grid openings than used in the original analysis of a sample. Results shall be within 1.5X of Poisson standard deviation. This shall be performed at a frequency of 1 per 100 samples. (EPA/600/R-94/134, Method 100.2, Table 2)

b. Duplicate. A second aliquot of sample shall be filtered through a second filter, prepared and analyzed in the same manner as the original preparation of that sample. Results shall be within 2.0X of Poisson standard deviation. This shall be performed at a frequency of one per 100 samples. (EPA/600/R-94/134, Method 100.2, Table 2)

c. Verified analyses. A second, independent analysis shall be performed on the same grids and grid openings used in the original analysis of a sample. The two sets of results shall be compared according to Turner and Steel (NISTIR 5351). This shall be performed at a frequency of one per 20 samples. Qualified analysts shall maintain an average of = 80% true positives, = 20% false negatives, and = 10% false positives.

2. Air.

a. All analyses shall be performed on relocator grids so that other laboratories can easily repeat analyses on the same grid openings.

b. The laboratory and TEM analysts shall obtain mean analytical results on NIST SRM 1876b so that trimmed mean values fall within 80% of the lower limit and 110% of the upper limit of the 95% confidence limits as published on the certificate. These limits are derived from the allowable false positives and false negatives given in subdivision A 2 e (3) of this subsection. SRM 1876b shall be analyzed a minimum of once per year by each TEM analyst.

c. The laboratory shall have documentation demonstrating that TEM analysts correctly classify at least 90% of both bundles and single fibrils of asbestos structures greater than or equal to 1 mm in length in known standard materials traceable to NIST, such as NIST bulk asbestos SRM 1866.

d. Interlaboratory analyses shall be performed to detect laboratory bias. The frequency of interlaboratory verified analysis shall correspond to a minimum of 1 per 200 grid square analyses.

e. If more than one TEM is used for asbestos analysis, intermicroscope analyses shall be performed to detect instrument bias.

(1) Replicate. A second, independent analysis shall be performed in accordance with Section D.6.2.1.1.a. (AHERA, Table III)

(2) Duplicate. A second wedge from a sample filter shall be prepared and analyzed in the same manner as the original preparation of that sample. Results shall be within 2.0X of Poisson standard deviation. This shall be performed at a frequency of 1 per 100 samples. (AHERA, Table III)

(3) Verified analyses. A second, independent analysis shall be performed on the same grids and grid openings in accordance with subdivision A 1 c of this section.

3. Bulk samples. Determination of precision and accuracy should follow guidelines in NISTIR 5951, Guide for Quality Control on the Qualitative and Quantitative Analysis of Bulk Asbestos Samples: Version 1. Because bulk samples with low (< 10%) asbestos content are the most problematic, a laboratory's quality control program should focus on such samples. At least 30% of a laboratory's QC analyses shall be performed on samples containing from 1.0% to 10% asbestos.

a. Intra-analyst precision. At least one out of 50 samples shall be reanalyzed by the same analyst. For single analyst laboratories, at least one out of every 10 samples shall be reanalyzed by the same analyst.

b. Inter-analyst precision. At least one out of 15 samples shall be reanalyzed by another analyst. Inter-analyst results will require additional reanalysis, possibly including another analyst, to resolve discrepancies when classification (ACM vs. non-ACM) errors occur, when asbestos identification errors occur, or when inter-analyst precision is found to be unacceptable.

c. Inter-laboratory precision. The laboratory shall participate in round robin testing with at least one other laboratory. Samples shall be sent to this other lab at least four times per year. These samples shall be samples previously analyzed as QC samples. Results of these analyses shall be assessed in accordance with QC requirements. As a minimum, the QC requirements shall address misclassifications (false positives, false negatives) and misidentification of asbestos types.

B. Phase contrast microscopy.

1. Inter-laboratory precision. Each laboratory analyzing air samples for compliance determination shall implement an inter-laboratory quality assurance program that as a minimum includes participation of at least two other independent laboratories. Each laboratory shall participate in round robin testing at least once every six months with at least all the other laboratories in its inter-laboratory quality assurance group. Each laboratory shall submit slides typical of its own workload for use in this program. The round robin shall be designed and results analyzed using appropriate statistical methodology. Results of this QA program shall be posted in each laboratory to keep the microscopists informed.

2. Intra- and inter-analyst precision. Each analyst shall select and count a prepared slide from a "reference slide library" on each day on which air counts are performed. Reference slides shall be prepared using well-behaved samples taken from the laboratory workload. Fiber densities shall cover the entire range routinely analyzed by the laboratory. These slides shall be counted by all analysts to establish an original standard deviation and corresponding limits of acceptability. Results from the daily reference sample analysis shall be compared to the statistically derived acceptance limits using a control chart or a database. It is recommended that the labels on the reference slides be periodically changed so that the analysts do not become familiar with the samples. Intra- and inter-analyst precision may be estimated from blind recounts on reference samples. Inter-analyst precision shall be posted in each laboratory to keep the microscopists informed.

C. Polarized light microscopy. Refer to subdivision A 3 of this section.

1VAC30-45-823. Asbestos testing: other quality control measures. (Repealed.)

A. Transmission electron microscopy.

1. Water and wastewater.

a. Filter preparations shall be made from all six asbestos types from NIST SRMs 1866 and 1867. These preparations shall have concentrations between one and 20 structures (> 10 µm) per 0.01 mm². One of these preparations shall be analyzed independently at a frequency of one per 100 samples analyzed. Results shall be evaluated as verified asbestos analysis in accordance with Turner and Steel (NISTIR 5351).

b. NIST SRM 1876b shall be analyzed annually by each analyst. Results shall be evaluated in accordance with limits published for that SRM. This SRM is not strictly appropriate for waterborne asbestos but analysts can demonstrate general TEM asbestos competence by producing results within the published limits of this (the only recognized TEM counting standard) SRM.

2. Air.

a. Filter preparations shall be made from all six asbestos types in accordance with subdivision A 1 a of this section.

b. NIST SRM 1876b shall be analyzed annually in accordance with subdivision A 1 b of this section.

3. Bulk samples. All analysts shall be able to correctly identify the six regulated asbestos types (chrysotile, amosite, crocidolite, anthophyllite, actinolite, and tremolite). Standards for the six asbestos types listed are available from NIST (SRMs 1866 and 1867). These materials can also be used as identification standards for AEM (Section 3.2.1 Qualitative Analysis, Page 57, EPA/600/R-93/116).

B. Phase contrast microscopy.

1. Test for nonrandom fiber distribution. Blind recounts by the same analyst shall be performed on 10% of the filters counted. A person other than the counter should re-label slides before the second count. A test for type II error (NIOSH 7400, Issue 2, 15 August 1994, Section 13) shall be performed to determine whether a pair of counts by the same analyst on the same slide should be rejected due to nonrandom fiber distribution. If a pair of counts is rejected by this test, the remaining samples in the set shall be recounted and the new counts shall be tested against first counts. All rejected paired counts shall be discarded. It shall not be necessary to use this statistic on blank recounts.

2. All individuals performing airborne fiber analysis shall have taken the NIOSH Fiber Counting Course for sampling and evaluating airborne asbestos dust or an equivalent course.

3. All laboratories shall participate in a national sample testing scheme such as the Proficiency Analytical Testing (PAT) program or the Asbestos Analysts Registry (AAR) program, both sponsored by the American Industrial Hygiene Association (AIHA), or equivalent.

C. Polarized light microscopy.

1. Friable materials. Because accuracy cannot be determined by reanalysis of routine field samples, at least one out of 100 samples shall be a standard or reference sample that has been routinely resubmitted to determine analyst's precision and accuracy. A set of these samples should be accumulated from proficiency testing samples with predetermined weight compositions or from standards generated with weighed quantities of asbestos and other bulk materials (Perkins and Harvey, 1993; Parekh et al., 1992; Webber et al., 1982). At least half of the reference samples submitted for this QC shall contain between 1.0% and 10% asbestos.

2. Nonfriable materials. At least one out of 100 samples shall be a verified quantitative standard that has routinely been resubmitted to determine analyst precision and accuracy.

1VAC30-45-824. Asbestos testing: method evaluation. (Repealed.)

In order to ensure the accuracy of reported results, the following procedures shall be in place:

1. Demonstration of capability shall be performed initially (prior to the analysis of any samples) and with a significant change in instrument type, personnel, or method.

2. Performance audits. The results of such analyses shall be used by the laboratory to evaluate the ability of the laboratory to produce accurate data.

1VAC30-45-825. Asbestos testing: asbestos calibration. (Repealed.)

Refer to methods referenced in the following sections for specific equipment requirements.

1. Transmission electron microscopy: general. Analytical electron microscopy equipment will not be discussed in this document.

2. Transmission electron microscopy: water and wastewater. All calibrations listed below (unless otherwise noted) shall be performed under the same analytical conditions used for routine asbestos analysis and shall be recorded in a notebook and include date and analyst's signature. Frequencies stated below may be reduced to "before next use" if no samples are analyzed after the last calibration period has expired. Likewise, frequencies may have to be increased following non-routine maintenance or unacceptable calibration performance.

a. Magnification calibration. Magnification calibration shall be done at the fluorescent screen, with the calibration specimen at the eucentric position, at the magnification used for fiber counting, generally 10,000 and 20,000x. A logbook shall be maintained with the dates of the calibration recorded. Calibrations shall be performed monthly to establish the stability of magnification. Calibration data shall be displayed on control charts that show trends over time. (EPA/600/R-94/134, Method 100.2, Section 10.1)

b. Camera constant. The camera length of the TEM in the Selected Area Electron Diffraction (SAED) mode shall be calibrated before SAED patterns of unknown samples are observed. The diffraction specimen shall be at the eucentric position for this calibration. This calibration shall allow accurate (< 10% variation) measurement of layer-line spacings on the medium used for routine measurement, i.e., the phosphor screen or camera film. This shall also allow accurate (< 5.0% variation) measurement of zone axis SAED patterns on permanent media, e.g., film. Calibrations shall be performed monthly to establish the stability of the camera constant (EPA/600/R-94/134, Method 100.2, Section 10.2). Where nonasbestiform minerals may be expected (e.g., winchite, richterite, industrial talc, vermiculite, etc.), an internal camera constant standard such as gold, shall be deposited and measured on each sample to facilitate accurate indexing of zone axis SAED patterns. In such cases, layer line analysis alone shall not be used. Calibration data shall be displayed on control charts that show trends over time.

c. Spot size. The diameter of the smallest beam spot at crossover shall be less than 250 nm as calibrated quarterly. Calibration data shall be displayed on control charts that show trends over time. (EPA/600/R-94/134, Method 100.2, Section 10.3)

d. Beam dose. The beam dose shall be calibrated so that beam damage to chrysotile is minimized, specifically so that an electron diffraction pattern from a single fibril =1 µm in length from a NIST SRM chrysotile sample is stable in the electron beam dose for at least 15 seconds.

e. EDXA system.

(1) The x-ray energy vs. channel number for the EDXA system shall be calibrated to within 20 eV for at least two peaks between 0.7 keV and 10 keV. One peak shall be from the low end (0.7 keV to 2 keV) and the other peak from the high end (7 keV to 10 keV) of this range. The calibration of the x-ray energy shall be checked prior to each analysis of samples and recalibrated if out of the specified range.

(2) The ability of the system to resolve the Na Ka line from the Cu L line shall be confirmed quarterly by obtaining a spectrum from the NIST SRM 1866 crocidolite sample on a copper grid.

(3) The k-factors for elements found in asbestos (Na, Mg, Al, Si, Ca, and Fe) relative to Si shall be calibrated semiannually, or anytime the detector geometry may be altered. NIST SRM 2063a shall be used for Mg, Si, Ca, Fe, while k-factors for Na and Al may be obtained from suitable materials such as albite, kaersutite, or NIST SRM 99a. The k-factors shall be determined to a precision (2s) within 10% relative to the mean value obtained for Mg, Al, Si, Ca, and Fe, and within 20% relative to the mean value obtained for Na. The k-factor relative to Si for Na shall be between 1.0 and 4.0, for Mg and Fe shall be between 1.0 and 2.0, and for Al and Ca shall be between 1.0 and 1.75. The k-factor for Mg relative to Fe shall be 1.5 or less. Calibration data shall be displayed on control charts that show trends over time.

(4) The detector resolution shall be checked quarterly to ensure a full-width half-maximum resolution of <175 eV at Mn Ka (5.90 keV). Calibration data shall be displayed on control charts that show trends over time.

(5) The portions of a grid in a specimen holder for which abnormal x-ray spectra are generated under routine asbestos analysis conditions shall be determined and these areas shall be avoided in asbestos analysis.

(6) The sensitivity of the detector for collecting x-rays from small volumes shall be documented quarterly by collecting resolvable Mg and Si peaks from a unit fibril of NIST SRM 1866 chrysotile.

f. Low temperature asher. The low temperature asher shall be calibrated quarterly by determining a calibration curve for the weight vs. ashing time of collapsed mixed-cellulose-ester (MCE) filters. Calibration data shall be displayed on control charts that show trends over time.

g. Grid openings. The magnification of the grid opening measurement system shall be calibrated using an appropriate standard at a frequency of 20 openings/20 grids/lot of 1000 or one opening/sample. The variation in the calibration measurements (2s) is <5.0% of the mean calibration value.

3. Air. All calibrations shall be performed in accordance with subdivision 2 of this section, with the exception of magnification. Magnification calibration shall be done at the fluorescent screen, with the calibration specimen at the eucentric position, at the magnification used for fiber counting, generally 15,000 to 20,000x (AHERA, III.G.1.c). A logbook shall be maintained with the dates of the calibration recorded. Calibrations shall be performed monthly to establish the stability of magnification.

4. Bulk samples. All calibrations shall be performed in accordance with subdivision 3 of this section.

5. Phase contrast microscopy.

a. At least once daily, the analyst shall use the telescope ocular (or Bertrand lens, for some microscopes) supplied by the manufacturer to ensure that the phase rings (annular diaphragm and phase-shifting elements) are concentric.

b. The phase-shift limit of detection of the microscope shall be checked monthly or after modification or relocation using an HSE/NPL phase-contrast test slide for each analyst/microscope combination (refer to NIOSH 7400, Issue 2, 15 August 1994, Section 10b). This procedure assures that the minimum detectable fiber diameter (< ca. 0.25mm) for this microscope is achieved.

c. Prior to ordering the Walton-Beckett graticule, calibration, in accordance with NIOSH 7400, Issue 2, 15 August 1994, Appendix A, shall be performed to obtain a counting area 100 mm in diameter at the image plane. The diameter, d_c (mm), of the circular counting area and the disc diameter shall be specified when ordering the graticule. The field diameter (D) shall be verified (or checked), to a tolerance of 100 µm ± 2 µm, with a stage micrometer upon receipt of the graticule from the manufacturer. When changes (zoom adjustment, disassembly, replacement, etc.) occur in the eyepiece-objective-reticle combination, field diameter shall be remeasured (or recalibrated) to determine field area (mm²). Recalibration of field diameter shall also be required when there is a change in interpupillary distance (i.e., change in analyst). Acceptable range for field area shall be 0.00754 mm² to 0.00817 mm². The actual field area shall be documented and used.

6. Polarized light microscopy.

a. Microscope alignment. To accurately measure the required optical properties, a properly aligned polarized light microscope (PLM) shall be utilized. The PLM shall be aligned before each use. (Section 2.2.5.2.3, EPA/600/R-93/116, July 1993)

b. Refractive index liquids. Series of n_D = 1.49 through 1.72 in intervals less than or equal to 0.005. Refractive index liquids for dispersion staining, high-dispersion series 1.550, 1.605, 1.680. The accurate measurement of the refractive index (RI) of a substance requires the use of calibrated refractive index liquids. These liquids shall be calibrated at first use and semiannually, or next use, whichever is less frequent, to an accuracy of 0.004, with a temperature accuracy of 2°C using a refractometer or RI glass beads.

1VAC30-45-826. Asbestos testing: analytical sensitivity. (Repealed.)

A. Transmission electron microscopy.

1. Water and wastewater. An analytical sensitivity of 200,000 fibers per liter (0.2 MFL) is required for each sample analyzed (EPA/600/R-94/134, Method 100.2, Section 1.6). Analytical sensitivity is defined as the waterborne concentration represented by the finding of one asbestos structure in the total area of filter examined. This value will depend on the fraction of the filter sampled and the dilution factor (if applicable).

2. Air. An analytical sensitivity of 0.005 structures/cm² is required for each sample analyzed. Analytical sensitivity is defined as the airborne concentration represented by the finding of one asbestos structure in the total area of filter examined. This value will depend on the effective surface area of the filter, the filter area analyzed, and the volume of air sampled (AHERA, Table I).

3. Bulk samples.

a. The range is dependent on the type of bulk material being analyzed. The sensitivity may be as low as 0.0001% depending on the extent to which interfering materials can be removed during the preparation of AEM specimens. (Section 2.5.2 Range, Page 51, EPA/600/R-93/116)

b. There should be an error rate of less than 1.0% on the qualitative analysis for samples that contain chrysotile, amosite, and crocidolite. A slightly higher error rate may occur for samples that contain anthophyllite, actinolite, and tremolite, as it can be difficult to distinguish among the three types. (Section 3, Page 10, NIST Handbook 150-3, August 1994)

B. Phase contrast microscopy. The normal quantitative working range of the test method is 0.04 to 0.5 fiber/cm² for a 1000 L air sample. An ideal counting range on the filter shall be 100 to 1300 fibers/mm². The limit of detection (LOD) is estimated to be 5.5 fibers per 100 fields or 7 fibers/mm². The LOD in fiber/cc will depend on sample volume and quantity of interfering dust but shall be <0.01 fiber/cm² for atmospheres free of interferences. (NIOSH 7400, Issue 2, 15 August 1994)

C. Polarized light microscopy. The laboratory shall utilize a test method that provides a limit of detection that is appropriate and relevant for the intended use of the data. Limit of detection shall be determined by the protocol in the test method or applicable regulation.

1VAC30-45-827. Asbestos testing: data reduction. (Repealed.)

A. Transmission electron microscopy.

1. Water and wastewater.

a. The concentration of asbestos in a given sample shall be calculated in accordance with EPA/600/R-94/134, Method 100.2, Section 12.1. Refer to 1VAC30-45-730 K for additional data reduction requirements.

b. Measurement uncertainties. The laboratory shall calculate and report the upper and lower 95% confidence limits on the mean concentration of asbestos fibers found in the sample (EPA/600/R-94/134, Method 100.2, Section 12.2.2).

2. Air.

a. The concentration of asbestos in a given sample shall be calculated in accordance with the method utilized, e.g., AHERA. Refer to 1VAC30-45-730 K for additional data reduction requirements.

b. Measurement uncertainties. The laboratory shall calculate and report the upper and lower 95% confidence limits on the mean concentration of asbestos fibers found in the sample.

3. Bulk samples.

a. The concentration of asbestos in a given sample shall be calculated in accordance with the method utilized (e.g., EPA/600/R-93/116, July 1993). Refer to 1VAC30-45-730 K for additional data reduction requirements.

b. Measurement uncertainties. Proficiency testing for floor tiles analyzed by TEM following careful gravimetric reduction (New York ELAP Certification Manual Item 198.4) has revealed an interlaboratory standard deviation of approximately 20% for residues containing 70% or more asbestos. Standard deviations range from 20% to 60% for residues with lower asbestos content.

B. Phase contrast microscopy.

1. Airborne fiber concentration in a given sample shall be calculated in accordance with NIOSH 7400, Issue 2, 15 August 1994, Sections 20 and 21. Refer to 1VAC30-45-730 K for additional data reduction requirements.

2. Measurement uncertainties. The laboratory shall calculate and report the intra-laboratory and inter-laboratory relative standard deviation with each set of results. (NIOSH 7400, Issue 2, 15 August 1994)

3. Fiber counts above 1300 fibers/mm² and fiber counts from samples with >50% of the filter area covered with particulate should be reported as "uncountable" or "probably biased." Other fiber counts outside the 100-1300 fibers/mm² range should be reported as having "greater than optimal variability" and as being "probably biased."

C. Polarized light microscopy.

1. The concentration of asbestos in a given sample shall be calculated in accordance with the method utilized (e.g., EPA/600/R-93/116, July 1993). Refer to 1VAC30-45-730 K for additional data reduction requirements.

2. Method uncertainties. The individual laboratory shall determine precision and accuracy for the percent range involved. If point counting and/or visual estimates are used, a table of reasonable expanded errors (refer to EPA/600/R-93/116, July 1993, Table 2-1) should be generated for different concentrations of asbestos.

1VAC30-45-828. Asbestos testing: quality of standards and reagents. (Repealed.)

A. Transmission electron microscopy.

1. The quality control program shall establish and maintain provisions for asbestos standards.

a. Reference standards that are used in an asbestos laboratory shall be obtained from the National Institute of Standards and Technology (NIST), EPA, or suppliers who participate in supplying NIST standards or NIST traceable asbestos. Any reference standards purchased outside the United States shall be traceable back to each country's national standards laboratory. Commercial suppliers of reference standards shall conform to ANSI N42.22 to assure the quality of their products.

b. Reference standards shall be accompanied with a certificate of calibration whose content is as described in ANSI N42.22-1995, Section 8, Certificates.

2. All reagents used shall be analytical reagent grade or better.

3. The laboratory shall have mineral fibers or data from mineral fibers that will allow differentiating asbestos from at least the following "look-alikes": fibrous talc, sepiolite, wollastonite, attapulgite (palygorskite), halloysite, vermiculite scrolls, antigorite, lizardite, pyroxenes, hornblende, richterite, winchite, or any other asbestiform minerals that are suspected as being present in the sample.

B. Phase contrast microscopy. Standards of known concentration have not been developed for this testing method. Routine workload samples that have been statistically validated and national proficiency testing samples such as PAT and AAR samples available from the AIHA may be utilized as reference samples (refer to 1VAC30-45-822 B 2) to standardize the optical system and analyst. All other testing reagents and devices (HSE/NPL test slide and Walton-Beckett Graticule) shall conform to the specifications of the method (refer to NIOSH 7400, Issue 2, 15 August 1994).

C. Polarized light microscopy. Refer to 1VAC30-45-828 A.

1VAC30-45-829. Asbestos testing: constant and consistent test conditions. (Repealed.)

The laboratory shall establish and adhere to written procedures to minimize the possibility of cross-contamination between samples.

1VAC30-45-850. Sample handling, sample acceptance policy, and sample receipt.

While the laboratory may not have control of field sampling activities, the following are essential to ensure the validity of the laboratory's data.

1. Sample tracking. The laboratory shall have a documented system for uniquely identifying the items to be tested to ensure that there can be no confusion regarding the identity of such items at any time. This system shall include identification for all samples, subsamples and subsequent extracts or digestates or both. The use of container shape, size or other physical characteristic, such as amber glass or purple top, is not an acceptable means of identifying the sample. System laboratories shall use a permanent chronological record such as a logbook or electronic database to document receipt of all containers. This sample receipt log shall record the following at a minimum: name of facility where sample was taken, date and time of laboratory receipt, unique laboratory ID code, and signature or initials of the person making the entries.

2. Sample acceptance policy. The laboratory shall have a written sample acceptance policy that clearly outlines the circumstances under which samples shall be accepted or rejected. The policy shall ensure that only properly obtained samples with appropriate sampling records (see 1VAC30-45-640 B) are analyzed and that the samples are handled properly. This sample acceptance policy shall be made available to sample collection personnel. The policy shall include elements such as appropriate documentation of the sample's identification, use of appropriate sample containers, adherence to specified holding times, adequate sample volume to perform necessary tests, and procedures to be used when samples show signs of damage, contamination or inadequate preservation.

3. Sample receipt protocols.

a. Upon receipt, the condition of the sample, including any abnormalities or departures from standard condition as prescribed in the relevant test method, shall be recorded. All items specified by the sample acceptance policy shall be checked.

b. All samples that require thermal preservation shall be considered acceptable if the arrival temperature is either within 2 degrees Celsius °C of the required temperature or the method specified range. For samples with a specified temperature of 4 degrees Celsius °C, samples with a temperature of ranging from just above freezing temperature of water to 6 degrees Celsius °C shall be acceptable. Samples that are hand delivered to the laboratory immediately after collection or on the same day that are collected may not meet this these criteria. In these cases, the samples shall be considered acceptable if there is evidence that the chilling process has begun such as arrival on ice. Thermal preservation is not required in the field if the laboratory receives the sample and either begins the analysis or refrigerates the sample within 15 minutes of collection.

c. The laboratory shall implement procedures for checking chemical preservation using readily available techniques, such as pH or free chlorine prior to or during sample preparation or analysis.

d. The results of all checks required by the sample acceptance policy and relevant test method shall be recorded.

4. Storage conditions.

a. The laboratory shall have documented procedures and appropriate facilities to avoid deterioration, contamination or damage to the sample during storage, handling, preparation, and testing. Any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded.

b. Samples shall be stored according to the conditions specified by preservation protocols:

(1) Samples that require thermal preservation shall be stored under refrigeration that is within 2 degrees Celsius °C of the specified preservation temperature unless method specific criteria exist. For samples with a specified storage temperature of 4 degrees Celsius °C, storage at a temperature above the freezing point of water to 6 degrees Celsius °C shall be acceptable.

(2) Samples shall be stored away from all standards, reagents, food and other potentially contaminating sources. Samples shall be stored in such a manner to prevent cross contamination.

c. Sample fractions, extracts, leachates and other sample preparation products shall be stored according to subdivision 4 a of this section or according to specifications in the test method.

d. Where a sample or portion of the sample is to be held secure (for example (e.g., for reasons of record, safety or value, or to enable check calibrations or tests to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned.

5. Sample disposal. The laboratory shall have standard operating procedures for the disposal of samples, digestates, leachates and extracts or other sample preparation products.

FORMS (1VAC30-45)

Application for Certification of Environmental Laboratories DGS-21-156 (eff. 1/09) (Application for Certification under 1VAC30-45 must be obtained from DCLS program staff at Lab_Cert@dgs.virginia.gov)

DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-45)

The Standards for Environmental Laboratories and Accreditation Bodies, 2009, The NELAC Institute (TNI), P.O. Box 2439, Weatherford, TX 76086; www.nelac-institute.org:

Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (EL-V1-2009)

Volume 2: General Requirements for Accreditation Bodies Accrediting Environmental Laboratories (EL-V2-2009)

Title of Regulation: 2VAC5-585. Retail Food Establishment Regulations (amending 2VAC5-585-40 through 2VAC5-585-100, 2VAC5-585-130 through 2VAC5-585-200, 2VAC5-585-220, 2VAC5-585-230, 2VAC5-585-250 through 2VAC5-585-410, 2VAC5-585-430 through 2VAC5-585-600, 2VAC5-585-620, 2VAC5-585-630, 2VAC5-585-650 through 2VAC5-585-680, 2VAC5-585-700 through 2VAC5-585-765, 2VAC5-585-780 through 2VAC5-585-870, 2VAC5-585-900, 2VAC5-585-930 through 2VAC5-585-960, 2VAC5-585-980, 2VAC5-585-990, 2VAC5-585-1000, 2VAC5-585-1070, 2VAC5-585-1090, 2VAC5-585-1100, 2VAC5-585-1110, 2VAC5-585-1120, 2VAC5-585-1180, 2VAC5-585-1190, 2VAC5-585-1230, 2VAC5-585-1240, 2VAC5-585-1300 through 2VAC5-585-1330, 2VAC5-585-1350, 2VAC5-585-1360, 2VAC5-585-1370, 2VAC5-585-1450, 2VAC5-585-1460, 2VAC5-585-1500 through 2VAC5-585-1570, 2VAC5-585-1630 through 2VAC5-585-1680, 2VAC5-585-1700, 2VAC5-585-1720, 2VAC5-585-1730, 2VAC5-585-1740, 2VAC5-585-1770, 2VAC5-585-1780, 2VAC5-585-1790, 2VAC5-585-1810, 2VAC5-585-1890, 2VAC5-585-1900, 2VAC5-585-1920, 2VAC5-585-1960, 2VAC5-585-2000, 2VAC5-585-2010, 2VAC5-585-2040 through  2VAC5-585-2110, 2VAC5-585-2120 through 2VAC5-585-2210, 2VAC5-585-2230 through 2VAC5-585-2280, 2VAC5-585-2310 through 2VAC5-585-2360, 2VAC5-585-2420, 2VAC5-585-2430, 2VAC5-585-2460, 2VAC5-585-2490, 2VAC5-585-2520, 2VAC5-585-2540, 2VAC5-585-2550, 2VAC5-585-2570, 2VAC5-585-2840, 2VAC5-585-2930, 2VAC5-585-2990 through 2VAC5-585-3040, 2VAC5-585-3070, 2VAC5-585-3130, 2VAC5-585-3150, 2VAC5-585-3210, 2VAC5-585-3240, 2VAC5-585-3250, 2VAC5-585-3270, 2VAC5-585-3310 through 2VAC5-585-3480, 2VAC5-585-3500, 2VAC5-585-3510, 2VAC5-585-3541, 2VAC5-585-3542, 2VAC5-585-3600, 2VAC5-585-3620, 2VAC5-585-3630, 2VAC5-585-3800 through 2VAC5-585-3840, 2VAC5-585-3860, 2VAC5-585-3910, 2VAC5-585-3930, 2VAC5-585-3940, 2VAC5-585-3950, 2VAC5-585-4040, 2VAC5-585-4050, 2VAC5-585-4060; adding 2VAC5-585-65, 2VAC5-585-67, 2VAC5-585-255, 2VAC5-585-725, 2VAC5-585-755, 2VAC5-585-1435, 2VAC5-585-1535, 2VAC5-585-1885, 2VAC5-585-2045, 2VAC5-585-2505, 2VAC5-585-2595, 2VAC5-585-3047, 2VAC5-585-3655, 2VAC5-585-3660; repealing 2VAC5-585-15, 2VAC5-585-1870).

Statutory Authority: § 3.2-5121 of the Code of Virginia.

Effective Date: July 12, 2016.

Agency Contact: Ryan Davis, Program Manager, Office of Dairy and Foods, Department of Agriculture and Consumer Services, P.O. Box 1163, Richmond, VA 23218, telephone (804) 786-8910, FAX (804) 371-7792, TTY (800) 828-1120, or email ryan.davis@vdacs.virginia.gov.

Summary:

The Retail Food Establishment Regulations (2VAC5-585) establish minimum sanitary standards for retail food establishments such as supermarkets, grocery stores, and convenience stores. Those standards include the safe and sanitary maintenance, storage, operation, and use of equipment; the safe preparation, handling, protection, and preservation of food including necessary refrigeration or heating methods and procedures for vector and pest control; requirements for toilet and handwashing facilities for employees; requirements for appropriate lighting and ventilation; requirements for an approved water supply and sewage disposal system; personal hygiene standards for employees; and the appropriate use of precautions to prevent the transmission of communicable diseases.

The current regulation is based on the U.S. Food and Drug Administration (FDA) 2005 Food Code and the 2007 Food Code Supplement. The existing regulation is amended to be consistent with the current 2013 FDA Food Code. Many of the changes refine and provide further clarity to existing regulations.

Amendments include requirements that (i) retail food establishments must refrigerate cut leafy greens in order to ensure that the product is safe to consume; (ii) food establishments must have employees who are fully informed regarding food allergens and their dangers; (iii) retail food establishment employees must be aware of their responsibility to inform management of any health or illness issue that might affect the safety of food products; (iv) the food establishment must have procedures in place for addressing vomitus or fecal matter discharge on surfaces in the food establishment; (v) wild mushrooms cannot be sold unless the establishment has been approved to do so by the regulatory authority; (vi) bare hand contact with ready-to-eat food ingredients is allowed in certain instances; (vii) game animals that are sold must be raised, slaughtered, and processed under a voluntary inspection program that is conducted by the U.S. Department of Agriculture or the state agency that has animal health jurisdiction; (viii) the food establishment must discontinue operations and notify the Virginia Department of Agriculture and Consumer Services if an imminent health hazard exists at the establishment; (ix) the food establishment must immediately contact the agency to report a food employee illness due to nontyphoidal Salmonella if it is determined that the illness is of a nature that can be transmitted through food; (x) the food establishment must correct all priority item violations within 72 hours and all priority foundation item violations within 10 days; and (xi) the food establishment must have at least one supervisor who is a certified food protection manager.

Changes made to the final regulation include (i) adding definitions for "approved water system," "potable water," "private well," "pure water," and "waterworks"; (ii) making the person in charge responsible for ensuring that employees are properly maintaining the temperatures of time/temperature control for safety foods during hot and cold holding; (iii) removing definitions for "drinking water" and "public water system"; (iii) requiring food allergy awareness as a component of employee training; (iv) updating the Guide for Control of Molluscan Shellfish to the 2013 edition; (v) exempting eggs sold pursuant to § 3.2-5305 of the Code of Virginia from the U.S. Consumer Grade B tolerances; (vi) requiring a food establishment to provide cleaning agents and sanitizers during hours of operation; (vii) requiring a food establishment to sample its water system before placing the system into service; (viii) requiring a food establishment to test its water for nitrate and total coliform; (ix) requiring food establishments to maintain reports of water samples for five years; (x) requiring that the water source in a food establishment meet both the maximum daily and peak hourly water demands; (xi) adding provisions to allow dogs to accompany patrons in certain food establishments that provide food service in an outdoor setting; (xii) requiring the inclusion of additional information in a Hazard Analysis and Critical Control Points plan; and (xiii) requiring the Virginia Department of Agriculture and Consumer Services to provide training and continuing education to its inspectors.

The amendments are adopted concurrently with the Virginia Department of Health action adopting certain changes based on the 2013 FDA Food Code and Supplement, also published in this issue of the Virginia Register of Regulations.

2VAC5-585-15. Categories of requirements. (Repealed.)

Requirements contained in this regulation are presented as being in one of three categories of importance: critical item (as defined in 2VAC5-585-40); "swing" (i.e., those that may or may not be critical depending on the circumstances); and noncritical. An asterisk (*) after a catchline (the language immediately following a section number that introduces the subject of the section) indicates that all of the provisions within that section are critical unless otherwise indicated, as follows:

1. Any provisions that are "swing" items are followed by the superscripted letter S and any provisions that are noncritical are followed by the superscripted letter N.

2. Any unmarked provisions within a section that has an asterisked catchline are critical. All provisions following a catchline that is not marked with an asterisk are noncritical.

Article 2
Definitions

2VAC5-585-40. Definitions.

The following words and terms when used in this regulation chapter shall have the following meanings unless the context clearly indicates otherwise:

"Accredited program" means a food protection manager certification program that has been evaluated and listed by an accrediting agency as conforming to national standards for organizations that certify individuals. "Accredited program" refers to the certification process and is a designation based upon an independent evaluation of factors such as the sponsor's mission; organizational structure; staff resources; revenue sources; policies; public information regarding program scope, eligibility requirements, recertification, discipline, and grievance procedures; and test development and administration. "Accredited program" does not refer to training functions or educational programs.

"Additive" means either a (i) "food additive" having the meaning stated in the Federal Food, Drug, and Cosmetic Act, 21 USC § 321(s) and 21 CFR Part 170 170.3(e)(1) or (ii) "color additive" having the meaning stated in the Federal Food, Drug, and Cosmetic Act, 21 USC § 321(t) and 21 CFR Part 70 70.3(f).

"Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, 21 USC § 342.

"Approved" means acceptable to the department based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.

[ "Approved water system" means a permitted waterworks constructed, maintained, and operated pursuant to 12VAC5-590 or a private well constructed, maintained, and operated pursuant to 12VAC5-630. ]

"Asymptomatic" means without obvious symptoms; not showing or producing indication indications of a disease or other medical condition, such as an individual infected with a pathogen but not exhibiting or producing any signs or symptoms of vomiting, diarrhea, or jaundice. Asymptomatic includes not showing symptoms because symptoms have resolved or subsided, or because symptoms never manifested.

"a_w" "A_w" means water activity that is a measure of the free moisture in a food, is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature, and is indicated by the symbol a_w A_w.

"Balut" means an embryo inside a fertile egg that has been incubated for a period sufficient for the embryo to reach a specific stage of development after which it is removed from incubation before hatching.

"Beverage" means a liquid for drinking, including water.

"Board" means the Board of Agriculture and Consumer Services.

"Bottled drinking water" means water that is sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water.

"Casing" means a tubular container for sausage products made of either natural or artificial (synthetic) material.

"Certification number" means a unique combination of letters and numbers assigned by a shellfish control authority to a molluscan shellfish dealer according to the provisions of the National Shellfish Sanitation Program. 

"CFR" means Code of Federal Regulations. Citations in this chapter to the CFR refer sequentially to the title, part, and section numbers [ for. For ] example, 40 CFR 180.194 refers to Title 40, Part 180, Section 194.

"CIP" means cleaned in place by the circulation or flowing by mechanical means through a piping system of a detergent solution, water rinse, and sanitizing solution onto or over equipment surfaces that require cleaning, such as the method used, in part, to clean and sanitize a frozen dessert machine. "CIP" does not include the cleaning of equipment such as band saws, slicers, or mixers that are subjected to in-place manual cleaning without the use of a CIP system.

"CFR" means Code of Federal Regulations. Citations in this regulation to the CFR refer sequentially to the title, part, and section numbers, such as 21 CFR 178.1010 refers to Title 21, Part 178, Section 1010.

"Code of Federal Regulations" means the compilation of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government that:

1. Is published annually by the U.S. Government Printing Office; and

2. Contains FDA rules in 21 CFR, USDA rules in 7 CFR and 9 CFR, EPA rules in 40 CFR, and Wildlife and Fisheries rules in 50 CFR.

"Commingle" means:

1. To combine shellstock harvested on different days or from different growing areas as identified on the tag or label; or

2. To combine shucked shellfish from containers with different container codes or different shucking dates.

"Comminuted" means reduced in size by methods including chopping, flaking, grinding, or mincing. "Comminuted" includes (i) fish or meat products that are reduced in size and restructured or reformulated such as gefilte fish, gyros, ground beef, and sausage; and (ii) a mixture of two or more types of meat that have been reduced in size and combined, such as sausages made from two or more meats.

"Commissioner" means the Commissioner of Agriculture and Consumer Services, his duly designated officer, or his agent.

"Conditional employee" means a potential food employee to whom a job offer is made, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990.

"Confirmed disease outbreak" means a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative organism or chemical agent and epidemiological analysis implicates the food as the source of the illness.

"Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment or food processing plant, and does not offer the food for resale.

"Core item" means a provision in this chapter that is not designated as a priority item or a priority foundation item. "Core item" includes an item that usually relates to general sanitation, operational controls, sanitation standard operating procedures, facilities or structures, equipment design, or general maintenance.

"Corrosion-resistant materials" means a material that maintains acceptable surface cleanability characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and sanitizing solutions, and other conditions of the use environment.

"Counter-mounted equipment" means equipment that is not easily movable portable and is designed to be mounted off the floor on a table, counter, or shelf.

"Critical control point" means a point or procedure in a specific food system where loss of control may result in an unacceptable health risk.

"Critical item" means a provision of this regulation that, if in noncompliance, is more likely than other violations to contribute to food contamination, illness, or environmental health hazard. "Critical item" is an item that is denoted in this regulation with an asterisk (*).

"Critical limit" means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that the identified food safety hazard may occur.

"Cut leafy greens" means fresh leafy greens whose leaves have been cut, shredded, sliced, chopped, or torn. The term "leafy greens" includes iceberg lettuce, romaine lettuce, leaf lettuce, butter lettuce, baby leaf lettuce (i.e., immature lettuce or leafy greens), escarole, endive, spring mix, spinach, cabbage, kale, arugula, and chard. The term "leafy greens" does not include herbs such as cilantro or parsley.

"Dealer" means a person who is authorized by a shellfish control authority for the activities of a shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor of molluscan shellfish according to the provisions of the National Shellfish Sanitation Program.

"Department" means the Virginia Department of Agriculture and Consumer Services.

"Disclosure" means a written statement that clearly identifies the animal-derived foods that are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens in their entirety, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

 [ "Drinking water" means water that meets the "water quality standards" requirements for bacteria and nitrates of the Virginia Waterworks Regulations (12VAC5-590). Drinking water is traditionally known as "potable water." Drinking water includes the term water except where the term used connotes that the water is not potable, such as "boiler water," "mop water," "rainwater," "wastewater," and ] "nondrinking" water [ "nondrinking water." ]

"Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not potentially hazardous time/temperature control for safety food and dry goods such as single-service items.

"Easily cleanable" means a characteristic of a surface that:

1. Allows effective removal of soil by normal cleaning methods;

2. Is dependent on the material, design, construction, and installation of the surface; and

3. Varies with the likelihood of the surface's role in introducing pathogenic or toxigenic agents or other contaminants into food based on the surface's approved placement, purpose, and use.

"Easily cleanable" includes a tiered application of the criteria that qualify the surface as easily cleanable as specified above in this definition to different situations in which varying degrees of cleanability are required such as:

1. The appropriateness of stainless steel for a food preparation surface as opposed to the lack of need for stainless steel to be used for floors or for tables used for consumer dining; or

2. The need for a different degree of cleanability for a utilitarian attachment or accessory in the kitchen as opposed to a decorative attachment or accessory in the consumer dining area.

"Easily movable" means:

1. Portable; mounted on casters, gliders, or rollers; or provided with a mechanical means to safely tilt a unit of equipment for cleaning; and

2. Having no utility connection, a utility connection that disconnects quickly, or a flexible utility connection line of sufficient length to allow the equipment to be moved for cleaning of the equipment and adjacent area.

"Egg" means the shell egg of avian species such as chicken, duck, goose, guinea, quail, ratites, or turkey. Egg does not include a balut, egg of the reptile species such as alligator, or an egg product.

"Egg product" means all, or a portion of, the contents found inside eggs separated from the shell and pasteurized in a food processing plant, with or without added ingredients, intended for human consumption, such as dried, frozen, or liquid eggs. Egg product does not include food that contains eggs only in a relatively small proportion such as cake mixes.

"Employee" means the operator, person in charge, food employee, person having supervisory or management duties, person on the payroll, family member, volunteer, person performing work under contractual agreement, or other person working in a food establishment.

"Enterohemorrhagic Escherichia coli (EHEC)" means E. coli, which cause hemorrhagic colitis, meaning bleeding enterically or bleeding from the intestine. The term is typically used in association with E. coli that have the capacity to produce Shiga toxins and to cause attaching and effacing lesion in the intestine. EHEC is a subset of Shiga toxin-producing Escherichia coli (STEC), whose members produce additional virulence factors. Infections with EHEC may be asymptomatic but are classically associated with bloody diarrhea (hemorrhagic colitis) and hemolytic euremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP). Examples of serotypes of EHEC include: E. coli O157:H7; E. coli O157:NM; E. coli O26:H11; E. coli O145:NM; E. coli O103:H2; or E. coli O111:NM. Also see Shiga toxin-producing E. coli.

"EPA" means the U.S. Environmental Protection Agency.

"Equipment" means an article that is used in the operation of a food establishment. "Equipment" includes, but is not limited to, items, such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine.

"Equipment" does not include items apparatuses used for handling or storing large quantities of packaged foods that are received from a supplier in a cased or overwrapped lot, such as hand trucks, forklifts, dollies, pallets, racks, and skids.

"Exclude" means to prevent a person from working as a food an employee in a food establishment or entering a food establishment as an employee.

"°F" means degrees Fahrenheit.

"FDA" means the U.S. Food and Drug Administration.

"Fish" means fresh or saltwater finfish, crustaceans, and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals; all mollusks, if such animal life is intended for human consumption; and includes any edible human food product derived in whole or in part from fish, including fish that has been processed in any manner.

"Food" means (i) a raw, cooked, or processed edible substance, ice, beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption or (ii) chewing gum.

"Foodborne disease outbreak" means the occurrence of two or more cases of a similar illness resulting from the ingestion of a common food.

"Food-contact surface" means a surface of equipment or a utensil with which food normally comes into contact, or a surface of equipment or a utensil from which food may drain, drip, or splash into a food, or onto a surface normally in contact with food.

"Food employee" means an individual working with unpackaged food, food equipment or utensils, or food-contact surfaces.

"Food establishment," as used in this regulation, means an operation that stores, prepares, packages, serves, vends food directly to the consumer, or otherwise offers for retail sale provides food for human consumption (i) such as a market;, restaurant;, satellite or catered feeding location;, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people;, vending location;, conveyance used to transport people;, institution;, or food bank and (ii) that relinquishes possession of a food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant take out takeout orders, or delivery service that is provided by common carriers.

"Food establishment," as used in this regulation, includes (i) an element of the operation such as a transportation vehicle or a central preparation facility that supplies a vending location or satellite feeding location and (ii) an operation that is conducted in a mobile, stationary, temporary, or permanent facility or location, where consumption is on or off the premises.

"Food establishment," as used in this regulation, does not include:

1. An establishment that offers only prepackaged foods that are not potentially hazardous time/temperature control for safety foods;

2. A produce stand that only offers whole, uncut fresh fruits and vegetables;

3. A food processing plant, including those that are located on the premises of a food establishment;

4. A food warehouse;

5. A kitchen in a private home; or

6. A private home that receives catered or home delivered food.

"Food processing plant" means a commercial operation that manufactures, packages, labels, or stores food for human consumption and provides food for sale or distribution to other business entities such as food processing plants or food establishments. "Food processing plant" does not include a "food establishment" as previously defined in this section. establishment."

"Game animal" means an animal, the products of which are food, that is not classified as cattle, (i) livestock, sheep, swine, goat, horse, mule, or other equine in 9 CFR Part 301, Definitions, as Poultry in 9 CFR Part 381, Poultry Products Inspection Regulations, or as fish as previously defined in this section. 301.2; (ii) poultry; or (iii) fish. "Game animal" includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat, and nonaquatic reptiles such as land snakes. "Game animal" does not include ratites such as ostrich, emu, and rhea.

"General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175.

"Grade A standards" means the requirements of the United States Public Health Service/FDA "Grade "A" Pasteurized Milk Ordinance (2003)", 2013 Revision, (U.S. Food and Drug Administration) and "Grade A Condensed and Dry Milk Ordinance (1995)" with which certain fluid and dry milk and milk products comply.

"HACCP Plan" plan" means a written document that delineates the formal procedures for following the Hazard Analysis Critical Control Point principles developed by the National Advisory Committee on Microbiological Criteria for Foods.

"Handwashing sink" means a lavatory, a basin or vessel for washing, a wash basin, or a plumbing fixture especially placed for use in personal hygiene and designed for the washing of hands. Handwashing sink includes an automatic handwashing facility.

"Hazard" means a biological, chemical, or physical property that may cause an unacceptable consumer health risk.

"Health practitioner" means a physician licensed to practice medicine, or if allowed by law, a nurse practitioner, physician assistant, or similar medical profession professional.

"Hermetically sealed container" means a container that is designed and intended to be secure against the entry of microorganisms and, in the case of low acid canned foods, to maintain the commercial sterility of its contents after processing.

"Highly susceptible population" means persons who are more likely than other people in the general population to experience foodborne disease because they are (i) immunocompromised; preschool age children, or older adults; and (ii) obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center.

"Imminent health hazard" means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries, and the nature, severity, and duration of the anticipated injury.

"Injected" means tenderizing a meat with deep penetration or injecting the meat such as with juices that may be referred to as "injecting," "pinning," or "stitch pumping." During injection infectious or toxigenic microorganisms may be introduced from its surface to its interior. manipulating meat to which a solution has been introduced into its interior by processes such as "injecting," "pump marinating," or "stitch pumping."

"Juice" means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purées of the edible portions of one or more fruits or vegetables, or any concentrate of such liquid or purée. Juice does not include, for purposes of HACCP, liquids, purées, or concentrates that are not used as beverages or ingredients of beverages.

"Kitchenware" means food preparation and storage utensils.

"Law" means applicable local, state, and federal statutes, regulations, and ordinances.

"Linens" means fabric items such as cloth hampers, cloth napkins, table cloths, wiping cloths, and work garments, including cloth gloves.

"Major food allergen" means milk, egg, fish (such as bass, flounder, cod, and including crustacean shellfish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or walnuts), wheat, peanuts, and soybeans; or a food ingredient that contains protein derived from one of these foods. Major food allergen does not include (i) any highly refined oil derived from a major food allergen in this definition and any ingredient derived from such highly refined oil; or (ii) any ingredient that is exempt under the petition or notification process specified in the Food Allergen Labeling and Consumer Protection Act of 2004 (P. L. 108-282, Title II, Sec. 201) (Pub. L. No. 108-282).

"Meat" means the flesh of animals used as food including the dressed flesh of cattle, swine, sheep, or goats and other edible animals, except fish, poultry, and wild game animals as specified under 2VAC5-585-330 A 2 and 3 and 4.

"Mechanically tenderized" means manipulating meat with deep penetration by processes that may be referred to as "blade tenderizing," "jaccarding," "pinning," "needling," or using blades, pins, needles or any mechanical device. "Mechanically tenderized" does not include processes by which solutions are injected into meat.

"mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

"Molluscan shellfish" means any edible species of fresh or frozen oysters, clams, mussels, and scallops or edible portions thereof, except when the scallop product consists only of the shucked adductor muscle.

"Noncontinuous cooking" means the cooking of food in a food establishment using a process in which the initial heating of the food is intentionally halted so that it may be cooled and held for complete cooking at a later time prior to sale or service. "Noncontinuous cooking" does not include cooking procedures that only involve temporarily interrupting or slowing an otherwise continuous cooking process.

"Operator" means the entity that is legally responsible for the operation of the food establishment such as the owner, the owner's agent, or other person.

"Packaged" means bottled, canned, cartoned, securely bagged, or securely packaged wrapped, whether packaged in a food establishment or a food processing plant. "Packaged" does not include a wrapper, carry-out box, or other nondurable container used to containerize food with the purpose of facilitating food protection during service and receipt of the food by the consumer. wrapped or placed in a carry-out container to protect the food during service or delivery to the consumer, by a food employee, upon consumer request.

"Person" means an association, a corporation, individual, partnership, other legal entity, government, or governmental subdivision or agency.

"Person in charge" means the individual present at a food establishment who is responsible for the operation at the time of inspection.

"Personal care items" means items or substances that may be poisonous, toxic, or a source of contamination and are used to maintain or enhance a person's health, hygiene, or appearance. Personal care items include items such as medicines;, first aid supplies;, and other items such as cosmetics, and toiletries such as toothpaste and mouthwash.

"pH" means the symbol for the negative logarithm of the hydrogen ion concentration, which is a measure of the degree of acidity or alkalinity of a solution. Values between 0 and 7.0 indicate acidity and values between 7.0 and 14 indicate alkalinity. The value for pure distilled water is 7.0, which is considered neutral.

"Physical facilities" means the structure and interior surfaces of a food establishment including accessories such as soap and towel dispensers and attachments such as light fixtures and heating or air conditioning system vents.

"Plumbing fixture" means a receptacle or device that is permanently or temporarily connected to the water distribution system of the premises and demands a supply of water from the system or discharges used water, waste materials, or sewage directly or indirectly to the drainage system of the premises.

"Plumbing system" means the water supply and distribution pipes; plumbing fixtures and traps; soil, waste, and vent pipes; sanitary and storm sewers and building drains, including their respective connections, devices, and appurtenances within the premises; and water-treating equipment.

"Poisonous or toxic materials" means substances that are not intended for ingestion and are included in four categories:

1. Cleaners and sanitizers, which include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

2. Pesticides, except sanitizers, which include substances such as insecticides and rodenticides;

3. Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants, paints, and personal care items that may be deleterious to health; and

4. Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints.

[ "Potable water" means water fit for human consumption that is obtained from an approved water supply and that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the person served. Potable water is traditionally known as drinking water and excludes such nonpotable forms as boiler water, mop water, rainwater, wastewater, and nondrinking water. ]

"Potentially hazardous food (time/temperature control for safety food)" means a food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation:

1. Potentially hazardous food (time/temperature control for safety food) includes an animal food that is raw or heat-treated; a plant food that is heat-treated or consists of raw seed sprouts, cut melons, cut tomatoes, or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way that results in mixtures that do not support pathogenic microorganism growth or toxin formation; and except as specified in subdivision 2 of this definition, a food that because of the interaction of its A_w and pH values is designated as Product Assessment Required (PA) in Table A or B of this definition:

Table A. Interaction of pH and Aw for control of spores in food heat treated to destroy vegetative cells and subsequently packaged.
Aw values	pH values
	4.6 or less	>4.6-5.6	>5.6
<0.92	non-PHF*/non-TCS food**	non-PHF/non-TCS food	non-PHF/non-TCS food
> 0.92-0.95	non-PHF/non-TCS food	non-PHF/non-TCS food	PA***
>0.95	non-PHF/non-TCS food	PA	PA
*PHF means Potentially Hazardous Food **TCS means Time/Temperature Control for Safety Food ***PA means Product Assessment required

 

Table B. Interaction of pH and Aw for control of vegetative cells and spores in food not heat treated or heat treated but not packaged.
Aw values	pH values
	< 4.2	4.2 - 4.6	> 4.6 - 5.0	> 5.0
<0.88	non-PHF*/non-TCS food**	non-PHF/non-TCS food	non-PHF/non-TCS food	non-PHF/non-TCS food
0.88-0.90	non-PHF/non-TCS food	non-PHF/non-TCS food	non-PHF/non-TCS food	PA***
>0.90-0.92	non-PHF/non-TCS food	non-PHF/non-TCS food	PA	PA
>0.92	non-PHF/non-TCS food	PA	PA	PA
*PHF means Potentially Hazardous Food **TCS means Time/Temperature Control for Safety Food ***PA means Product Assessment required

2. Potentially hazardous food (time/temperature control for safety food) does not include:

a. An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard boiled, but has been pasteurized to destroy all viable Salmonellae;

b. A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution;

c. A food that because of its pH or A_w value, or interaction of A_w and pH values, is designated as a non-PHF/non-TCS food in Table A or B of this definition;

d. A food that is designated as Product Assessment required (PA) in Table A or B of this definition and has undergone a Product Assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(1) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

(2) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf-life and use, or temperature range of storage and use; or

(3) A combination of intrinsic and extrinsic factors; or

e. A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the subdivisions 2 a through 2 d of this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

"Poultry" means any domesticated bird (chickens, turkeys, ducks, geese, or guineas), guineas, ratites, or squabs), whether live or dead, as defined in 9 CFR Part 381, Poultry Products Inspection Regulations, 381.1 and any migratory waterfowl, game bird, or squab such as pheasant, partridge, quail, grouse, or guineas, or pigeon or squab, whether live or dead, as defined in 9 CFR Part 362 362.1, Voluntary Poultry Inspection Regulations. "Poultry" does not include ratites.

"Premises" means the physical facility, its contents, and the contiguous land or property under the control of the operator or person in charge or the physical facility, its contents, and the land or property not described above if its facilities and contents are under the control of the operator and may impact food establishment personnel, facilities, or operations, and a food establishment is only one component of a larger operation.

"Primal cut" means a basic major cut into which carcasses and sides of meat are separated, such as a beef round, pork loin, lamb flank, or veal breast.

"Priority item" means a provision in this chapter whose application contributes directly to the elimination, prevention, or reduction to an acceptable level of hazards associated with foodborne illness or injury and there is no other provision that more directly controls the hazard. "Priority item" includes items with a quantifiable measure to show control of hazards such as cooking, reheating, cooling, and handwashing and is denoted in this chapter with a superscript P^p.

"Priority foundation item" means a provision in this chapter whose application supports, facilitates, or enables one or more priority items. "Priority foundation item" includes an item that requires the purposeful incorporation of specific actions, equipment, or procedures by industry management to attain control of risk factors that contribute to foodborne illness or injury such as personnel training, infrastructure or necessary equipment, HACCP plans, documentation or recordkeeping, and labeling and is denoted in this chapter with a superscript Pf^Pf.

 [ "Public water system" has the meaning stated in 40 CFR Part 141, National Primary Drinking Water Regulations.

"Private well" means any water well constructed for a person on land that is owned or leased by that person and is usually intended for household, groundwater source heat pump, agricultural use, industrial use, or other nonpublic water well.

"Pure water" means potable water fit for human consumption that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served. Potable water is traditionally known as drinking water and excludes such nonpotable forms as boiler water, mop water, rainwater, wastewater, and nondrinking water. ]

"Ratite" means a flightless bird such as an emu, ostrich, or rhea.

"Ready-to-eat food" means food that:

1. (i) Is in a form that is edible without additional preparation to achieve food safety, as specified under subsections A through C of 2VAC5-585-700 or A, B, and C; 2VAC5-585-710; or 2VAC5-585-730; (ii) is a raw or partially cooked animal food and the consumer is advised as specified under subdivisions D 1 and D 2 of 2VAC5-585-700 D 1 and D 3; or (iii) is prepared in accordance with a variance that is granted as specified under subdivisions D 1 and D 3 of 2VAC5-585-700 D 4; and

2. May receive additional preparation for palatability or aesthetic, epicurean, gastronomic, or culinary purposes.

"Ready-to-eat food" includes:

1. Raw animal food that is cooked as specified under 2VAC5-585-700 or 2VAC5-585-710, or frozen as specified under 2VAC5-585-730;

2. Raw fruits and vegetables that are washed as specified under 2VAC5-585-510;

3. Fruits and vegetables that are cooked for hot holding, as specified under 2VAC5-585-720;

4. All potentially hazardous food time/temperature control for safety food that is cooked to the temperature and time required for the specific food under Article 4 (2VAC5-585-700 et seq.) of Part III of this regulation chapter and cooled as specified in 2VAC5-585-800;

5. Plant food for which further washing, cooking, or other processing is not required for food safety, and from which rinds, peels, husks, or shells, if naturally present, are removed;

6. Substances derived from plants such as spices, seasonings, and sugar;

7. A bakery item such as bread, cakes, pies, fillings, or icing for which further cooking is not required for food safety;

8. The following products that are produced in accordance with USDA guidelines and that have received a lethality treatment for pathogens: dry, fermented sausages, such as dry salami or pepperoni; salt-cured meat and poultry products, such as prosciutto ham, country cured ham, and Parma ham; and dried meat and poultry products, such as jerky or beef sticks; and

9. Food manufactured according to 21 CFR Part 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.

"Reduced oxygen packaging" means (i) the reduction of the amount of oxygen in a package by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the atmosphere (approximately 21% at sea level); and (ii) a process as specified in clause (i) of this definition that involves a food for which the hazards Clostridium botulinum or Listeria monocytogenes require control in the final packaged form.

"Reduced oxygen packaging" includes:

1. Vacuum packaging, in which air is removed from a package of food and the package is hermetically sealed so that a vacuum remains inside the package, such as sous vide;

2. Modified atmosphere packaging, in which the atmosphere of a package of food is modified so that its composition is different from air but the atmosphere may change over time due to the permeability of the packaging material or the respiration of the food. Modified atmosphere packaging includes reduction in the proportion of oxygen, total replacement of oxygen, or an increase in the proportion of other gases such as carbon dioxide or nitrogen;

3. Controlled atmosphere packaging, in which the atmosphere of a package of food is modified so that until the package is opened, its composition is different from air, and continuous control of that atmosphere is maintained, such as by using oxygen scavengers or a combination of total replacement of oxygen, nonrespiring food, and impermeable packaging material;

4. Cook chill packaging, in which cooked food is hot filled into impermeable bags that have the air expelled and are then sealed or crimped closed. The bagged food is rapidly chilled and refrigerated at temperatures that inhibit the growth of psychotrophic pathogens; or

5. Sous vide packaging, in which raw or partially cooked food is placed in a hermetically sealed, vacuum packaged in an impermeable bag, cooked in the bag, rapidly chilled, and refrigerated at temperatures that inhibit the growth of psychotrophic pathogens.

"Refuse" means solid waste not carried by water through the sewage system.

"Regulatory authority" means local, state, or federal enforcement body or their authorized representative having jurisdiction over the food establishment.

"Reminder" means a written statement concerning the health risk of consuming animal foods raw, undercooked, or without otherwise being processed to eliminate pathogens.

"Reservice" means the transfer of food that is unused and returned by a consumer after being served or sold and in the possession of the consumer, to another person.

"Restrict" means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, and or unwrapped single-service or single-use articles.

"Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR Part 590.

"Restricted use pesticide" means a pesticide product that contains the active ingredients specified in 40 CFR 152.175 (pesticides classified for restricted use) and that is limited to use by or under the direct supervision of a certified applicator.

"Risk" means the likelihood that an adverse health effect will occur within a population as a result of a hazard in a food.

"Safe material" means an article manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food; an additive that is used as specified in § 409 or 706 of the Federal Food, Drug, and Cosmetic Act (21 USC §§ 348 and 376) (21 USC § 348); or other materials that are not additives and that are used in conformity with applicable regulations of the Food and Drug Administration.

"Sanitization" means the application of cumulative heat or chemicals on cleaned food contact food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a 5-log reduction of five logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

"Sealed" means free of cracks or other openings that permit allow the entry or passage of moisture.

"Service animal" means an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.

"Servicing area" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

"Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution.

"Shellfish control authority" means a state, federal, foreign, tribal, or other government entity legally responsible for administering a program that includes certification of molluscan shellfish harvesters and dealers for interstate commerce.

"Shellstock" means raw, in-shell molluscan shellfish.

"Shiga toxin-producing Escherichia coli" (STEC) or "STEC" means any E. coli capable of producing Shiga toxins (also called verocytotoxins or "Shiga-like" toxins) verocytotoxins). STEC infections can be asymptomatic or may result in a spectrum of illness ranging from mild nonbloody diarrhea to hemorrhagic colitis (i.e., bloody diarrhea) to hemolytic uremic syndrome (HUS), which is a type of kidney failure. Examples of serotypes of STEC include both O157 and non-O157 E.coli. Also see Enterohemorrhagic Escherichia coli.: E. coli O157:H7, E. coli O157:NM, E. coli O26:H11, E. coli O145:NM, E. coli O103:H2, and E. coli O111:NM. STEC are sometimes referred to as VTEC (verocytotoxigenic E. coli) or as EHEC (enterohemorrhagic E. coli). EHEC are a subset of STEC that can cause hemorrhagic colitis or HUS.

"Shucked shellfish" means molluscan shellfish that have one or both shells removed.

"Single-service articles" means tableware, carry-out utensils, and other items such as bags, containers, placemats, stirrers, straws, toothpicks, and wrappers that are designed and constructed for one time, one person use after which they are intended for discard.

"Single-use articles" means utensils and bulk food containers designed and constructed to be used once and discarded. Single-use articles includes items such as wax paper, butcher paper, plastic wrap, formed aluminum food containers, jars, plastic tubs or buckets, bread wrappers, pickle barrels, ketchup bottles, and number 10 cans that do not meet the materials, durability, strength, and cleanability specifications under 2VAC5-585-960, 2VAC5-585-1080, and 2VAC5-585-1100 for multiuse utensils.

"Slacking" means the process of moderating the temperature of a food such as allowing a food to gradually increase from a temperature of -10°F (-23°C) to 25°F (-4°C) in preparation for deep-fat frying or to facilitate even heat penetration during the cooking of previously block-frozen food such as spinach shrimp.

"Smooth" means a food-contact surface having a surface free of pits and inclusions with a cleanability equal to or exceeding that of (100 grit) number three stainless steel; a nonfood-contact surface of equipment having a surface equal to that of commercial grade hot-rolled steel free of visible scale; and a floor, wall, or ceiling having an even or level surface with no roughness or projections that render it difficult to clean.

"Tableware" means eating, drinking, and serving utensils for table use such as flatware including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, and tumblers; and plates.

"Temperature measuring device" means a thermometer, thermocouple, thermistor, or other device that indicates the temperature of food, air, or water.

"Temporary food establishment" means a food establishment that operates for a period of no more than 14 consecutive days in conjunction with a single event or celebration.

"Time/temperature control for safety food" or "TCS" (formerly "potentially hazardous food") means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation:

1. Time/temperature control for safety food includes an animal food that is raw or heat treated; a plant food that is heat treated or consists of raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation, or garlic-in-oil mixtures that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation; and except as specified in subdivision 2 d of this definition, a food that because of the interaction of its A_w and pH values is designated as product assessment required (PA) in Table A or B of this definition:

Table A. Interaction of pH and Aw for control of spores in food heat treated to destroy vegetative cells and subsequently packaged.
Aw values	pH values
	4.6 or less	>4.6-5.6	>5.6
=0.92	non-TCS food*	non-TCS food	non-TCS food
>0.92-0.95	non-TCS food	non-TCS food	PA**
>0.95	non-TCS food	PA	PA
*TCS means time/temperature control for safety food **PA means product assessment required

 

Table B. Interaction of pH and Aw for control of vegetative cells and spores in food not heat treated or heat treated but not packaged.
Aw values	pH values
	< 4.2	4.2 - 4.6	> 4.6 - 5.0	> 5.0
<0.88	non-TCS food*	non-TCS food	non-TCS food	non-TCS food
0.88-0.90	non-TCS food	non-TCS food	non-TCS food	PA**
>0.90-0.92	non-TCS food	non-TCS food	PA	PA
>0.92	non-TCS food	PA	PA	PA
*TCS means time/temperature control for safety food **PA means product assessment required

2. Time/temperature control for safety food does not include:

a. An air-cooled hard-boiled egg with shell intact, or an egg with shell intact that is not hard boiled, but has been pasteurized to destroy all viable salmonellae;

b. A food in an unopened hermetically sealed container that is commercially processed to achieve and maintain commercial sterility under conditions of nonrefrigerated storage and distribution;

c. A food that because of its pH or A_w value, or interaction of A_w and pH values, is designated as a non-TCS food in Table A or B of this definition;

d. A food that is designated as PA in Table A or B of this definition and has undergone a product assessment showing that the growth or toxin formation of pathogenic microorganisms that are reasonably likely to occur in that food is precluded due to:

(1) Intrinsic factors including added or natural characteristics of the food such as preservatives, antimicrobials, humectants, acidulants, or nutrients;

(2) Extrinsic factors including environmental or operational factors that affect the food such as packaging, modified atmosphere such as reduced oxygen packaging, shelf-life and use, or temperature range of storage and use; or

(3) A combination of intrinsic and extrinsic factors; or

e. A food that does not support the growth or toxin formation of pathogenic microorganisms in accordance with one of the subdivisions 2 a through 2 d of this definition even though the food may contain a pathogenic microorganism or chemical or physical contaminant at a level sufficient to cause illness or injury.

"USDA" means the U.S. Department of Agriculture.

"Utensil" means a food-contact implement or container used in the storage, preparation, transportation, dispensing, sale, or service of food, such as kitchenware or tableware that is multiuse, single service, or single use; gloves used in contact with food; temperature sensing probes of food temperature measuring devices; and probe-type price or identification tags used in contact with food.

"Variance" means a written document issued by the department that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the department, a health hazard or nuisance will not result from the modification or waiver.

"Vending machine" means a self-service device that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.

"Vending machine location" means the room, enclosure, space, or area where one or more vending machines are installed and operated and includes the storage and servicing areas on the premises that are used in conjunction with the vending machines areas and areas on the premises that are used to service and maintain the vending machines.

"Warewashing" means the cleaning and sanitizing of utensils and food-contact surfaces of equipment and utensils.

[ "Waterworks" means a system that serves piped water for human consumption to at least 15 service connections or 25 or more individuals for at least 60 days out of the year.  Waterworks includes all structures, equipment, and appurtenances used in the storage, collection, purification, treatment, and distribution of potable water except the piping and fixtures inside the building where such water is delivered. ]

"Whole-muscle, intact beef" means whole muscle beef that is not injected, mechanically tenderized, reconstructed, or scored and marinated, from which beef steaks may be cut.

Part II
Management and Personnel

Article 1
Supervision

2VAC5-585-50. Assignment of responsibility.*

The A. Except as specified in subsection B of this section, the operator shall be the person in charge or shall designate a person in charge and shall ensure that a person in charge is present at the food establishment during all hours of operation.^Pf

B. In a food establishment with two or more separately inspected departments that are the legal responsibility of the same operator and that are located on the same premises, the operator may, during specific time periods when food is not being prepared, packaged, or served, designate a single person in charge who is present on the premises during all hours of operation, and who is responsible for each separately inspected food establishment on the premises.^Pf

[ 2VAC5-585-55. Certified food protection manager.

A. At least one employee who has supervisory and management responsibility and the authority to direct and control food preparation and service shall be a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program.

B. This section does not apply to certain types of food establishments deemed by the regulatory authority to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of food preparation.

C. For purposes of enforcing this section, this requirement will take effect insert date 18 months after the effective date of this chapter.

2VAC5-585-57. Food protection manager certification.

A. A person in charge who demonstrates knowledge by being a food protection manager and is certified by a food protection manager certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with subdivision 2 of 2VAC5-585-60.

B. A food establishment that has an employee who is certified by a food protection manager certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with 2VAC5-585-55. ]

2VAC5-585-60. Demonstration.*

Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the department knowledge of foodborne disease prevention, application of the Hazard Analysis Critical Control Point principles, and the requirements of this regulation chapter. The person in charge shall demonstrate this knowledge by:

1. Complying with this regulation chapter by having no violations of priority items during the current inspection;^Pf

2. Being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program;^Pf or

3. Responding correctly to the inspector's questions as they relate to the specific food operation. The areas of knowledge include:

a. Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;^Pf

b. Explaining the responsibility of the person in charge for preventing the transmission of foodborne disease by a food employee who has a disease or medical condition that may cause foodborne disease;^Pf

c. Describing the symptoms associated with the diseases that are transmissible through food;^Pf

d. Explaining the significance of the relationship between maintaining the time and temperature of potentially hazardous food (time/temperature time/temperature control for safety food) food and the prevention of foodborne illness;^Pf

e. Explaining the hazards involved in the consumption of raw or undercooked meat, poultry, eggs, and fish;^Pf

f. Stating the required food temperatures and times for safe cooking of potentially hazardous food (time/temperature time/temperature control for safety food) food including meat, poultry, eggs, and fish;^Pf

g. Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of potentially hazardous food (time/temperature time/temperature control for safety food) food;^Pf

h. Describing the relationship between the prevention of foodborne illness and the management and control of the following:

(1) Cross contamination;^Pf

(2) Hand contact with ready-to-eat foods;^Pf

(3) Handwashing;^Pf and

(4) Maintaining the food establishment in a clean condition and in good repair;^Pf

i. Describing the foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual who has an allergic reaction;^Pf

j. Explaining the relationship between food safety and providing equipment that is:

(1) Sufficient in number and capacity;^Pf and

(2) Properly designed, constructed, located, installed, operated, maintained, and cleaned;^Pf

k. Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;^Pf

l. Identifying the source of water used and measures taken to ensure that it remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;^Pf

m. Identifying poisonous or toxic materials in the food establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to law;^Pf

n. Identifying critical control points in the operation from purchasing through sale or service that when not controlled may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the requirements of this regulation chapter;^Pf

o. Explaining the details of how the person in charge and food employees comply with the HACCP plan if a plan is required by the law, this regulation chapter, or an agreement between the department and the food establishment;^Pf

p. Explaining the responsibilities, rights, and authorities assigned by this regulation chapter to the:

(1) Food employee;^Pf

(2) Conditional employee;^Pf

(3) Person in charge;^Pf and

(3) (4) Department;^Pf and

q. Explaining how the person in charge, food employees, and conditional employees comply with reporting responsibilities and the exclusion or restriction of food employees.^Pf

 [ 2VAC5-585-65. Certified food protection manager.

A. At least one employee who has supervisory and management responsibility and the authority to direct and control food preparation and service shall be a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program.

B. This section does not apply to certain types of food establishments deemed by the regulatory authority to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and extent of food preparation.

C. For purposes of enforcing this section, this requirement will take effect July 1, 2018.

2VAC5-585-67. Food protection manager certification.

A. A person in charge who demonstrates knowledge by being a food protection manager and is certified by a food protection manager certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with subdivision 2 of 2VAC5-585-60.

B. A food establishment that has an employee who is certified by a food protection manager certification program that is evaluated and listed by a Conference for Food Protection-recognized accrediting agency as conforming to the Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, (Conference for Food Protection) is deemed to comply with 2VAC5-585-65. ]

2VAC5-585-70. Duties of person in charge.

The person in charge shall ensure that:

1. Food establishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under 2VAC5-585-2990;^Pf

2. Persons unnecessary to the food establishment operation are not allowed in the food preparation, food storage, or warewashing areas, except that brief visits and tours may be authorized by the person in charge if steps are taken to ensure that exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles are protected from contamination;^Pf

3. Employees and other persons such as delivery and maintenance persons and pesticide applicators entering the food preparation, food storage, and warewashing areas comply with this regulation chapter;^Pf

4. Employees are effectively cleaning their hands, by routinely monitoring the employees' handwashing;^Pf

5. Employees are visibly observing foods as they are received to determine that they are from approved sources, delivered at the required temperatures, protected from contamination, unadulterated, and accurately presented, by routinely monitoring the employees' observations and periodically evaluating foods upon their receipt;^Pf

6. Employees are verifying that foods delivered to the food establishment during nonoperating hours are from approved sources and are placed into appropriate storage locations such that they are maintained at the required temperatures, protected from contamination, unadulterated, and accurately presented;^Pf

7. Employees are properly cooking potentially hazardous food time/temperature control for safety food, being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats, through daily oversight of the employees' routine monitoring of the cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated as specified under 2VAC5-585-1180 and 2VAC5-585-1730 B;^Pf

7. 8. Employees are using proper methods to rapidly cool potentially hazardous foods time/temperature control for safety foods that are not held hot or are not for consumption within four hours, through daily oversight of the employees' routine monitoring of food temperatures during cooling;^Pf

8. 9. [ Employees are properly maintaining the temperatures of time/temperature control for safety food during hot and cold holding through daily oversight of the employees' routine monitoring of food temperatures;^Pf

10. ] Consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed as specified under 2VAC5-585-930 that the food is not cooked sufficiently to ensure its safety;^Pf

9. [ 10. 11. ] Employees are properly sanitizing cleaned multiuse equipment and utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing;^Pf

10. [ 11. 12. ] Consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets as specified under 2VAC5-585-590;^Pf

11. [ 12. 13. ] Except when otherwise approved approval is obtained from the department as specified in 2VAC5-585-450 B E, employees are preventing cross-contamination of ready-to-eat food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment;^Pf

12. [ 13. 14. ] Employees are properly trained in food safety, including food allergy awareness, as it relates to their assigned duties; and^Pf

13. [ 14. 15. ] Food employees and conditional employees are informed in a verifiable manner of their responsibility to report in accordance with law, to the person in charge, information about their health and activities as they relate to diseases that are transmissible through food, as specified under 2VAC5-585-80. A;^Pf and

[ 15. 16. ] Written procedures and plans where specified by this chapter and as developed by the food establishment are maintained and implemented as required.^Pf

Article 2
Employee Health

2VAC5-585-80. Responsibility of the operator, person in charge, and conditional employees.*

A. The person in charge operator shall require food employees and conditional employees to report to the person in charge information about their health and activities as they relate to diseases that are transmissible through food. A food employee or conditional employee shall report the information in a manner that allows the person in charge to reduce the risk of foodborne disease transmission, including providing necessary additional information, such as the date of onset of symptoms and an illness, or of a diagnosis without symptoms, if the food employee or conditional employee:

1. Has any of the following symptoms:

a. Vomiting;^P

b. Diarrhea;^P

c. Jaundice;^P

d. Sore throat with fever;^P or

e. A lesion containing pus such as a boil or infected wound that is open or draining and is:

(1) On the hands or wrists, unless an impermeable cover such as a finger cot or stall protects the lesion and a single-use glove is worn over the impermeable cover;^P

(2) On exposed portions of the arms, unless the lesion is protected by an impermeable cover;^P or

(3) On other parts of the body, unless the lesion is covered by a dry, durable, tight-fitting bandage;^P

2. Has an illness diagnosed by a health practitioner due to:

a. Norovirus;^P

b. Hepatitis A virus;^P

c. Shigella spp.;^P

d. Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing Escherichia coli; or^P

e. [ Salmonella Typhi Typhoid fever (caused by Salmonella typhi) ];^P or

f. [ Nontyphoidal Salmonella Salmonella (nontyphoidal) ];^P

3. Had [ a previous illness typhoid fever ], diagnosed by a health practitioner, within the past three months due to Salmonella [ Typhi typhi ], without having received antibiotic therapy, as determined by a health practitioner;^P

4. Has been exposed to, or is the suspected source of, a confirmed disease outbreak, because the food employee or conditional employee consumed or prepared food implicated in the outbreak, or consumed food at an event prepared by a person who is infected or ill with:

a. Norovirus within the past 48 hours of the last exposure;^P

b. Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing Escherichia coli, or Shigella spp. within the past three days of the last exposure;^P

c. [ Salmonella Typhi Typhoid fever ] within the past 14 days of the last exposure;^P or

d. Hepatitis A virus within the past 30 days of the last exposure;^P or

5. Has been exposed by attending or working in a setting where there is a confirmed disease outbreak, or living in the same household as, and has knowledge about an individual who works or attends a setting where there is a confirmed disease outbreak, or living in the same household as, and has knowledge about, an individual diagnosed with an illness caused by:

a. Norovirus within the past 48 hours of the last exposure;^P

b. Enterohemorragic or Shiga-toxin producing Shiga toxin-producing Escherichia coli, or Shigella spp. within the past three days of the last exposure;^P

c. [ Salmonella Typhi Typhoid fever (caused by Salmonella typhi) ] within the past 14 days of the last exposure;^P or

d. Hepatitis A virus within the past 30 days of the last exposure.^P

B. The person in charge shall notify the regulatory authority department when a food employee is:

1. Jaundiced;^Pf or

2. Diagnosed with an illness due to a pathogen as specified under subdivisions A 2 a through e f of this section.^Pf

C. The person in charge shall ensure that a conditional employee:

1. Who exhibits or reports a symptom, or who reports a diagnosed illness as specified under subdivisions A 2 a through e A 1 through 3 of this section, is prohibited from becoming a food employee until the conditional employee meets the criteria for the specific symptoms or diagnosed illness as specified under 2VAC5-585-100;^P and

2. Who will work as a food employee in a food establishment that serves a highly susceptible population and reports a history of exposure as specified under subdivisions A 4 and 5 of this section, is prohibited from becoming a food employee until the conditional employee meets the criteria specified under subdivision 9 10 of 2VAC5-585-100.^P

D. The person in charge shall ensure that a food employee who exhibits or reports a symptom, or who reports a diagnosed illness or a history of exposure as specified under subdivision subsection A 1 through 5 of this section is:

1. Excluded as specified under subdivisions 1 through 3 and 4 a, 5 a, 6 a, or 7, or 8 a of 2VAC5-585-90 and in compliance with the provisions specified under subdivisions 1 through 7 8 of 2VAC5-585-100;^P or

2. Restricted as specified under subdivisions subdivision 4 b, 5 b, 6 b, 7 b, 8 b, or 9, or 10 of 2VAC5-585-90 and in compliance with the provisions specified under subdivisions 4 through 9 10 of 2VAC5-585-100.^P

E. A food employee or conditional employee shall report to the person in charge the information as specified under subsection A of this section.^Pf

F. A food employee shall:

1. Comply with an exclusion as specified under subdivisions 1 through 3 and 4 a, 5 a, 6 a, or 7, or 8 a of 2VAC5-585-90, and with the provisions specified under subdivisions 1 through 7 8 of 2VAC5-585-100;^P or

2. Comply with a restriction as specified under subdivisons subdivision 4 b, 5 b, 6 b, 7 b, or 8, or 9 b of 2VAC5-585-90 or under subdivision 8, 9, or 10 of 2VAC5-585-90 and comply with the provisions specified under subdivisons subdivisions 4 through 9 10 of 2VAC5-585-100.^P

2VAC5-585-90. Exclusions and restrictions.*

The person in charge shall exclude or restrict a food employee from a food establishment in accordance with the following:

1. Except when the symptom is from a noninfectious condition, exclude a food employee if the food employee is:

a. Symptomatic with vomiting or diarrhea;^P or

b. Symptomatic with vomiting or diarrhea and diagnosed with an infection from Norovirus, Shigella spp., or Enterohemorrhagic [ nontyphoidal ] Salmonella [ (nontyphoidal) ], or Shiga-toxin producing Escherichia Shiga toxin-producing E. coli.^P

2. Exclude a food employee who is:

a. Jaundiced and the onset of jaundice occurred within the last seven calendar days, unless the food employee provides to the person in charge written medical documentation from a health practitioner specifying that the jaundice is not caused by Hepatitis A virus or other fecal-orally transmitted infection;^P

b. Diagnosed with an infection from Hepatitis A virus within 14 calendar days from the onset of any illness symptoms, or within seven calendar days of the onset of jaundice;^P or

c. Diagnosed with an infection from Hepatitis A virus without developing symptoms.^P

3. Exclude a food employee who is diagnosed with [ an infection from Salmonella Typhi typhoid fever ], or reports [ a previous infection with Salmonella Typhi having had typhoid fever ] within the past three months as specified in 2VAC5-585-80 A 3.^P

4. If a food employee is diagnosed with an infection from Norovirus and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

5. If a food employee is diagnosed with an infection from Shigella spp. and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

6. If a food employee is diagnosed with an infection from Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing E. coli, and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

7. If a food employee is diagnosed with an infection from [ nontyphoidal ] Salmonella [ (nontyphoidal) ] and is asymptomatic, restrict the food employee who works in a food establishment serving a highly susceptible population or in a food establishment not serving a highly susceptible population.^P

7. 8. If a food employee is ill with symptoms of acute onset of sore throat with fever:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

8. 9. If a food employee is infected with a skin lesion containing pus such as a boil or infected wound that is open or draining and not properly covered as specified under 2VAC5-585-80 A 1 e, restrict the food employee.^P

9. 10. If a food employee is exposed to a foodborne pathogen as specified under 2VAC5-585-80 A 4 or 5, restrict the food employee who works in a food establishment serving a highly susceptible population.^P

2VAC5-585-100. Removal of exclusions and restrictions.

The person in charge shall adhere to the following conditions when removing, adjusting, or retaining the exclusion or restriction of a food employee:

1. Except when a food employee is diagnosed with [ typhoid fever or ] an infection from Hepatitis A virus [ or Salmonella Typhi ]:

a. Reinstate a food employee who was excluded as specified under subdivision 1 a of 2VAC5-585-90 if the food employee:

(1) Is asymptomatic for at least 24 hours;^P or

(2) Provides to the person in charge written medical documentation from a health practitioner that states the symptom is from a noninfectious condition.^P

b. If a food employee was diagnosed with an infection from Norovirus and excluded as specified under subdivision 1 b of 2VAC5-585-90 1 b:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met.^P

c. If a food employee was diagnosed with an infection from Shigella spp. and excluded as specified under subdivision 1 b of 2VAC5-585-90:

(1) Restrict the food employee, who is asymptomatic, for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 5 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in (i) subdivision 5 a or 5 b of this section, or 5 a and c (1) (ii) subdivisions 1 c (1) and 5 a of this section are met.^P

d. If a food employee was diagnosed with an infection from Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing Escherichia coli and excluded as specified under subdivision 1 b of 2VAC5-585-90:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b are met.^P

e. If a food employee was diagnosed with an infection from [ nontyphoidal ] Salmonella [ (nontyphoidal) ] and excluded as specified in subdivision 1 b of 2VAC5-585-90:

(1) Restrict the food employee, who is asymptomatic, for at least 30 days until conditions for reinstatement as specified in subdivision 7 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is symptomatic, until conditions for reinstatement as specified in subdivision 7 a or b of this section are met.^P

2. Reinstate a food employee who was excluded as specified under subdivision 2 of 2VAC5-585-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The food employee has been jaundiced for more than seven calendar days;^P

b. The anicteric food employee has been symptomatic with symptoms other than jaundice for more than 14 calendar days;^P or

c. The food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Hepatitis A virus infection.^P

3. Reinstate a food employee who was excluded as specified under subdivision 3 of 2VAC5-585-90 if:

a. The person in charge obtains approval from the regulatory authority department;^P and

b. The food employee provides to the person in charge written medical documentation from a health practitioner that states the food employee is free from S. [ Salmonella Typhi infection typhoid fever ].^P

4. Reinstate a food employee who was excluded as specified under subdivision 1 b or 4 a of 2VAC5-585-90, who was restricted under subdivision 4 b of 2VAC5-585-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Norovirus infection;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than 48 hours have passed since the food employee became symptomatic asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than 48 hours have passed since the food employee was diagnosed.^P

5. Reinstate a food employee who was excluded as specified under subdivision 1 b or 5 a of 2VAC5-585-90 or who was restricted under subdivision 5 b of 2VAC5-585-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Shigella spp. infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics;^P and

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than seven calendar days have passed since the food employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than seven calendar days have passed since the food employee was diagnosed.^P

6. Reinstate a food employee who was excluded or restricted as specified under subdivision 1 b or 6 a of 2VAC5-585-90 or who was restricted under subdivision 6 b of 2VAC5-585-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of an infection from Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing Escherichia coli based on test results that show two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after the discontinuance of antibiotics;^P and

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved and more than seven calendar days have passed since the food employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than seven days have passed since the food employee was diagnosed.^P

7. Reinstate a food employee who was excluded as specified under subdivision 1 b of 2VAC5-585-90 or who was restricted under subdivision 7 of 2VAC5-585-90 if the person in charge obtains approval from the department^P and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a [ nontyphoidal ] Salmonella [ (nontyphoidal) ] infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics,^P and

(2) At least 24 hours apart;^P

b. The food employee was restricted after symptoms of vomiting or diarrhea resolved, and more than 30 days have passed since the food employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than 30 days have passed since the food employee was diagnosed.^P

7. 8. Reinstate a food employee who was excluded or restricted as specified under subdivision 7 8 a or b of 2VAC5-585-90 if the food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee meets one of the following conditions:

a. Has received antibiotic therapy for Streptococcus pyogenes infection for more than 24 hours;^P

b. Has at least one negative throat specimen culture for Streptococcus pyogenes infection;^P or

c. Is otherwise determined by a health practitioner to be free of Streptococcus pyogenes infection.^P

8. 9. Reinstate a food employee who was restricted as specified under subdivision 8 9 of 2VAC5-585-90 if the skin, infected wound, cut, or pustular boil is properly covered with one of the following:

a. An impermeable cover such as a finger cot or stall and a single-use glove over the impermeable cover if the infected wound or pustular boil is on the hand, finger, or wrist;^P

b. An impermeable cover on the arm if the infected wound or pustular boil is on the arm;^P or

c. A dry, durable, tight-fitting bandage if the infected wound or pustular boil is on another part of the body.^P

9. 10. Reinstate a food employee who was restricted as specified under subdivision 9 10 of 2VAC5-585-90 and was exposed to one of the following pathogens as specified under 2VAC5-585-80 A 4 or 5:

a. Norovirus and one of the following conditions is met:

(1) More than 48 hours have passed since the last day the food employee was potentially exposed;^P or

(2) More than 48 hours have passed since the food employee's household contact became asymptomatic.^P

b. Shigella spp. or Enterohemorrhagic or Shiga-toxin producing Shiga toxin-producing Escherichia coli and one of the following conditions is met:

(1) More than three calendar days have passed since the last day the food employee was potentially exposed;^P or

(2) More than three calendar days have passed since the food employee's household contact became asymptomatic.^P

c. S. [ Salmonella Typhi typhoid fever (caused by Salmonella typhi) ] and one of the following conditions is met:

(1) More than 14 calendar days have passed since the last day the food employee was potentially exposed;^P or

(2) More than 14 calendar days have passed since the food employee's household contact became asymptomatic.^P

d. Hepatitis A virus and one of the following conditions is met:

(1) The food employee is immune to Hepatitis A virus infection because of prior illness from Hepatitis A;^P

(2) The food employee is immune to Hepatitis A virus infection because of vaccination against Hepatitis A;^P

(3) The food employee is immune to Hepatitis A virus infection because of IgG administration;^P

(4) More than 30 calendar days have passed since the last day the food employee was potentially exposed;^P

(5) More than 30 calendar days have passed since the food employee's household contact became jaundiced;^P or

(6) The food employee does not use an alternative procedure that allows bare hand contact with ready-to-eat food until at least 30 days after the potential exposure, as specified in subdivision 9 10 d (4) and (5) of this section, and the food employee receives additional training about:

(a) Hepatitis A symptoms and preventing the transmission of infection;^P

(b) Proper handwashing procedures;^P and

(c) Protecting ready-to-eat food from contamination introduced by bare hand contact.^P

 [ 2VAC5-585-125. Clean-up of vomiting and diarrheal events.

 A food establishment shall have procedures for employees to follow when responding to vomiting or diarrheal events that involve the discharge of vomitus or fecal matter onto surfaces in the food establishment.

The procedures shall address the specific actions employees must take to minimize the spread of contamination and the exposure of employees, consumers, food, and surfaces to vomitus or fecal matter.^Pf ]

Article 3
Personal Cleanliness

2VAC5-585-130. Clean condition of hands and arms.*

Food employees shall keep their hands and exposed portions of their arms clean.^P

2VAC5-585-140. Cleaning procedure of hands and arms.*

A. Except as specified in subsection D of this section, food employees shall clean their hands and exposed portions of their arms (or, including surrogate prosthetic devices for hands or arms) arms for at least 20 seconds, using a cleaning compound in a lavatory handwashing sink that is equipped as specified under 2VAC5-585-2190 and 2VAC5-585-3020 through 2VAC5-585-3045.^P

B. Food employees shall use the following cleaning procedure in the order stated to clean their hands and exposed portions of their arms, including surrogate prosthetic devices for hands and arms:

1. Rinse under clean, running warm water;^P

2. Apply an amount of cleaning compound recommended by the cleaning compound manufacturer;^P

3. Rub together vigorously for at least 10 to 15 seconds while:

a. Paying particular attention to removing soil from underneath the fingernails during the cleaning procedure;^P and

b. Creating friction on the surfaces of the hands and arms or surrogate prosthetic devices for hands and arms, finger tips, and areas between the fingers;^P

4. Thoroughly rinsing under clean, running warm water;^P and

5. Immediately follow the cleaning procedure with thorough drying using a method as specified under 2VAC5-585-3030.^P

C. To avoid recontaminating their hands or surrogate prosthetic devices, food employees may use disposable paper towels or similar clean barriers when touching surfaces such as manually operated faucet handles on a handwashing sink or the handle of a restroom door.

D. If approved and capable of removing the types of soils encountered in the food operations involved, an automatic handwashing facility may be used by food employees to clean their hands or surrogate prosthetic devices.

2VAC5-585-160. When to wash.*

Food employees shall clean their hands and exposed portions of their arms as specified under 2VAC5-585-140 immediately before engaging in food preparation including working with exposed food, clean equipment and utensils, and unwrapped single-service and single-use articles^P and:

1. After touching bare human body parts or hair other than clean hands and clean, exposed portions of arms;^P

2. After using the toilet room;^P

3. After caring for or handling support service animals or aquatic animals as allowed under 2VAC5-585-250 B;^P

4. Except as specified in 2VAC5-585-220 B, after coughing, sneezing, using a handkerchief or disposable tissue, using tobacco, eating, or drinking;^P

5. After handling soiled equipment or utensils;^P

6. During food preparation, as often as necessary to remove soil and contamination and to prevent cross contamination when changing tasks;^P

7. When switching between working with raw foods food and working with ready-to-eat foods food;^P

8. Before donning gloves for to initiate a task that involves working with food;^P and

9. Prior to donning single-use gloves if gloves are used; and

10. After engaging in other activities that contaminate the hands.^P

2VAC5-585-170. Where to wash.

Food employees shall clean their hands in a hand washing lavatory handwashing sink or approved automatic hand washing handwashing facility and may not clean their hands in a sink used for food preparation or warewashing, or in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste.^Pf

2VAC5-585-180. Hand antiseptics.

A. A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall:

1. Comply with one of the following:

a. Be an approved drug that is listed in the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations, 34th Edition," 2014, (U.S. Food and Drug Administration) as an approved drug based on safety and effectiveness;^Pf or

b. Have active antimicrobial ingredients that are listed in the FDA tentative final monograph for over the counter (OTC) Health-Care Antiseptic Drug Products, 59 FR 31402-31452 (June 17, 1994) as an antiseptic handwash;^Pf and

2. Comply Consist only of components that the intended use of each complies with one of the following:

a. Have components that are exempted from the requirement of being listed in the federal Food Additive regulations as specified in A threshold of regulation exemption under 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles; or^Pf

b. Comply with and be listed in:

(1) 21 CFR Part 178, Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use; or

(2) 21 CFR Part 182, Substances Generally Recognized as Safe; 21 CFR Part 184, Direct Food Substances Affirmed as Generally Recognized as Safe; or 21 CFR Part 186, Indirect Food Substances Affirmed as Generally Recognized as Safe for use in contact with food; and

b. 21 CFR Part 178, as regulated for use as a food additive with conditions of safe use;^Pf

c. A determination of generally recognized as safe (GRAS). Partial listings of substances with food uses that are GRAS may be found in 21 CFR Part 182, 21 CFR Part 184, or 21 CFR Part 186; and in FDA's Inventory of GRAS Notices;^Pf

d. A prior sanction listed under 21 CFR Part 181;^Pf or

e. A food contact notification that is effective;^Pf and

3. Be applied only to hands that are cleaned as specified under 2VAC5-585-140.^Pf

B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under subdivision A 2 of this section, use shall be:

1. Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves;^Pf or

2. Limited to situations that involve no direct contact with food by the bare hands.^Pf

C. A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 ppm (mg/l) mg/l (ppm) chlorine or above.^Pf

2VAC5-585-190. Maintenance of fingernails.

A. Food employees shall keep their fingernails trimmed, filed, and maintained so the edges and surfaces are cleanable and not rough.^Pf

B. Unless wearing intact gloves in good repair, a food employee may not wear fingernail polish or artificial nails when working with exposed food.^Pf

2VAC5-585-200. Prohibition of jewelry.

While preparing food, food employees may not wear jewelry including medical information jewelry on their arms and hands. This section does not apply to a plain ring such as a wedding band. Except for a plain ring such as a wedding band, while preparing food, food employees may not wear jewelry, including medical information jewelry, on their arms and hands.

Article 4
Hygienic Practices

2VAC5-585-220. Eating, drinking, or using tobacco.*

A. Except as specified in subsection B of this section, an employee shall eat, drink, or use any form of tobacco only in designated areas where the contamination of exposed food; clean equipment, utensils, and linens; unwrapped single-service and single-use articles; or other items needing protection cannot result.

B. A food employee may drink from a closed beverage container with a straw if the container is handled to prevent contamination of:

1. The employee's hands;

2. The container; and

3. Exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles.

2VAC5-585-230. Discharges from the eyes, nose, and mouth.*

Food employees experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth may not work with exposed food; clean equipment, utensils, and linens; or unwrapped single-service or single-use articles.

2VAC5-585-250. Handling of animals prohibited.*

A. Except as specified in subsection B of this section, food employees may not care for or handle animals that may be present such as patrol dogs, support service animals, or pets that are allowed in as specified in subdivisions B 2 through B [ 5 6 ] of 2VAC5-585-3310.^Pf

B. Food employees with support service animals may handle or care for their support service animals and food employees may handle or care for fish in aquariums or molluscan shellfish or crustacea in display tanks if they wash their hands as specified under 2VAC5-585-140 and subdivision 3 of 2VAC5-585-160.

 [ 2VAC5-585-255. Clean-up of vomiting and diarrheal events.

A. A food establishment shall have procedures for employees to follow when responding to vomiting or diarrheal events that involve the discharge of vomitus or fecal matter onto surfaces in the food establishment.^Pf

B. The procedures shall address the specific actions employees must take to minimize the spread of contamination and the exposure of employees, consumers, food, and surfaces to vomitus or fecal matter.^Pf ]

Part III
Food

Article 1
Characteristics

2VAC5-585-260. Safe, unadulterated, and honestly presented.*

Food shall be safe, unadulterated, and, as specified under 2VAC5-585-890, honestly presented.^P

Article 2
Sources, Specifications, and Original Containers and Records

2VAC5-585-270. Compliance with food law.*

A. Food shall be obtained from sources that comply with law.^P

B. Food prepared in a private home may not be used or offered for human consumption in a food establishment unless the home kitchen is inspected by the responsible and regulated by the food regulatory authority that has jurisdiction over the private home.^P

C. Packaged food shall be labeled as specified in law, including 21 CFR Part 101, Food Labeling; 9 CFR Part 317, Labeling, Marking Devices, and Containers; and 9 CFR Part 381, Subpart N, Labeling and Containers; and as specified under 2VAC5-585-400 and 2VAC5-585-410.^Pf

D. Fish, other than molluscan shellfish, that are intended for consumption in their raw form and allowed as specified in 2VAC5-585-700 D 1 may be offered for sale or service if they are obtained from a supplier that freezes the fish as specified under 2VAC5-585-730, or frozen on the premises as specified under 2VAC5-585-730, and records are retained as specified under 2VAC5-585-740.

D. Fish, other than those specified in 2VAC5-585-730 B, that are intended for consumption in raw or undercooked form and allowed as specified in 2VAC5-585-700 D, may be offered for sale or service if they are obtained from a supplier that freezes fish as specified under 2VAC5-585-730 A, or if they are frozen on the premises as specified under 2VAC5-585-730 A and records are retained as specified under 2VAC5-585-740.

E. Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory as specified in 2VAC5-585-700 C shall be:

1. Obtained from a food processing plant that, upon request by the purchaser, packages the steaks and labels them to indicate that they the steaks meet the definition of whole-muscle, intact beef;^Pf or

2. Deemed acceptable by the department based on other evidence, such as written buyer specifications or invoices, that indicates that the steaks meet the definition of whole-muscle, intact beef;^Pf and

3. If individually cut in a food establishment:

a. Cut from whole-muscle, intact beef that is labeled by a food processing plant as specified in subdivision 1 of this subsection or identified as specified in subdivision 2 of this subsection;^Pf

b. Prepared so they remain intact;^Pf and

c. If packaged for undercooking in a food establishment, labeled to indicate that they meet the definition of whole-muscle, intact beef as specified in subdivision 1 of this subsection or identified as specified in subdivision 2 of this subsection.^Pf

F. Meat and poultry that are not a ready-to-eat food foods and are in a packaged form when offered for sale or otherwise offered for consumption shall be labeled to include safe handling instructions as specified in law, including 9 CFR 317.2(l) and 9 CFR 381.125(b).

G. Shell eggs Eggs that have not been specifically treated to destroy all viable Salmonellae shall be labeled to include safe handling instructions as specified in law, including 21 CFR 101.17(h).

2VAC5-585-280. Food in a hermetically sealed container.*

Food in a hermetically sealed container shall be obtained from a food processing plant that is regulated by the food regulatory agency that has jurisdiction over the plant.^P

2VAC5-585-290. Fluid milk and milk products.*

Fluid milk and milk products shall be obtained from sources that comply with Grade A standards as specified in law.^P

2VAC5-585-295. Juice treated.

Pre-packaged Prepackaged juice shall:

1. Be obtained from a processor with a HACCP system as specified in 21 CFR Part 120;^Pf and

2. Be obtained pasteurized or otherwise treated to attain a 5-log reduction of the most resistant microorganism of public health significance as specified in 21 CFR 120.24; or.^P

3. Bear a warning label as specified in 21 CFR 101.17(g).

2VAC5-585-300. Fish.*

A. Fish that are received for sale or service shall be:

1. Commercially and legally caught or harvested;^P or

2. Approved for sale or service by a regulatory authority.^P

B. Molluscan shellfish that are recreationally caught may not be received for sale or service.^P

2VAC5-585-310. Molluscan shellfish.*

A. Molluscan shellfish shall be obtained from sources according to law and the requirements specified in the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program Manual of Operations, Part II, Sanitation of the Harvesting, Processing and Distribution of Shellfish, 1995 Revision (NSSP) Guide for the Control of Molluscan Shellfish, [ 2011 2013 ] Revision, (U.S. Food and Drug Administration).^P

B. Molluscan shellfish [ received in interstate commerce ] shall be from sources that are listed in the "Interstate Certified Shellfish Shippers List," updated monthly (U.S. Food and Drug Administration).^P

2VAC5-585-320. Wild mushrooms.*

A. Except as specified in subsection B of this section, mushroom species picked in the wild shall be obtained from sources where each mushroom is individually inspected and found to be safe by an approved mushroom identification expert not be offered for sale or service by a food establishment unless the food establishment has been approved to do so.^P

B. This section does not apply to:

1. Cultivated wild mushroom species that are grown, harvested, and processed in an operation that is regulated by the food regulatory agency that has jurisdiction over the operation; or

2. Wild mushroom species if they are in packaged form and are the product of a food processing plant that is regulated by the food regulatory agency that has jurisdiction over the plant.

2VAC5-585-330. Game animals.*

A. If game animals are received for sale or service they shall be:

1. Commercially raised for food and: a. Raised raised, slaughtered, and processed under a voluntary inspection program that is conducted by the state agency that has animal health jurisdiction; or

b. Under a routine inspection program conducted by a regulatory agency other than the agency that has animal health jurisdiction; and

c. Raised, slaughtered, and processed according to:

(1) Laws governing meat and poultry as determined by the agency; and

(2) Requirements that are developed by the agency that has animal health jurisdiction and the agency that conducts the inspection program with consideration of factors such as the need for antemortem and postmortem examination by an approved veterinarian or veterinarian's designee;

2. Under under a voluntary inspection program administered by the USDA for game animals such as exotic animals including animals (i.e., reindeer, elk, deer, antelope, water buffalo, or bison) that are "inspected and approved" in accordance with 9 CFR Part 352, Exotic Animals; Voluntary Inspection, or rabbits that are "inspected and certified" in accordance with 9 CFR Part 354, Voluntary Inspection of Rabbits and Edible Products Thereof;^P

3. 2. As allowed by law, for wild game animals that are live-caught:

a. Under a routine inspection program conducted by a regulatory agency such as the agency that has animal health jurisdiction;^P

b. Slaughtered and processed according to:

(1) Laws governing meat and poultry as determined by the agency that has animal health jurisdiction and the agency that conducts the inspection program;^P and

(2) Requirements that are developed by the agency that has animal health jurisdiction and the agency that conducts the inspection program with consideration of factors such as the need for antemortem and postmortem examination by an approved veterinarian or veterinarian's designee;^P or

4. 3. As allowed by law for field-dressed wild game animals under a routine inspection program that ensures the animals:

a. Receive a postmortem examination by an approved veterinarian or veterinarian's designee, or are field-dressed and transported according to requirements specified by the agency that has animal health jurisdiction and the agency that conducts the inspection program; and^P

b. Are field-dressed and transported according to requirements specified by the agency that has animal health jurisdiction and the agency that conducts the inspection program;^P and

c. Are processed according to laws governing meat and poultry as determined by the agency that has animal health jurisdiction and the agency that conducts the inspection program.^P

B. A game animal may not be received for sale or service if it is a species of wildlife that is listed in 50 CFR Part 17, Endangered and Threatened Wildlife and Plants.

2VAC5-585-340. Temperature.*

A. Except as specified in subsection B of this section, refrigerated, potentially hazardous time/temperature control for safety food shall be at a temperature of 41°F (5°C) or below when received.^P

B. If a temperature other than 41°F (5°C) for a potentially hazardous time/temperature control for safety food is specified in law governing its distribution, such as laws governing milk, and molluscan shellfish, and shell eggs, the food may be received at the specified temperature.

C. Raw shell eggs shall be received in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

D. Potentially hazardous Time/temperature control for safety food that is cooked to a temperature and for a time specified under 2VAC5-585-700 through 2VAC5-585-720 and received hot shall be at a temperature of 135°F (57°C) or above.^P

E. A food that is labeled frozen and shipped frozen by a food processing plant shall be received frozen.^Pf

F. Upon receipt, potentially hazardous time/temperature control for safety food shall be free of evidence of previous temperature abuse.^Pf

2VAC5-585-350. Additives.*

Food may not contain unapproved food additives or additives that exceed amounts allowed specified in 21 CFR Parts 170-180 relating to food additives; generally recognized as safe or prior sanctioned substances that exceed amounts allowed specified in 21 CFR Parts 181-186; substances that exceed amounts specified in 9 CFR, Subpart C, 424.21(b), Approval of Substances for Use in the Preparation of Products; or pesticide residues that exceed provisions specified in 40 CFR Part 185, Tolerances for Pesticides in Food. 180.^P

2VAC5-585-360. Shell eggs Eggs.*

Shell eggs Eggs shall be received clean and sound and [ may shall ] not exceed the restricted egg tolerances for U.S. Consumer Grade B as specified in United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 56, effective July 20, 2000, AMS 56.200 et seq., administered by the (Agricultural Marketing Service of USDA).^P [ Eggs sold pursuant to § 3.2-5305 of the Code of Virginia are exempt from the restricted egg tolerances for U.S. Consumer Grade B as specified in the United States Standards, Grades, and Weight Classes for Shell Eggs, AMS 56, effective July 20, 2000, (Agricultural Marketing Service of USDA). ]

2VAC5-585-370. Eggs and milk products, pasteurized.*

A. Egg products shall be obtained pasteurized.^P

B. Fluid and dry milk and milk products shall:

1. Be obtained pasteurized;^P and

2. Comply with Grade A standards as specified in law.^P

C. Frozen milk products, such as ice cream, shall be obtained pasteurized in accordance with as specified in 21 CFR Part 135, Frozen Desserts.^P

D. Cheese shall be obtained pasteurized unless alternative procedures to pasteurization are provided for in the Code of Federal Regulations, specified in the CFR, such as 21 CFR Part 133, Cheeses and Related Cheese Products, for curing certain cheese varieties.^P

2VAC5-585-380. Package integrity.*

Food packages shall be in good condition and protect the integrity of the contents so that the food is not exposed to adulteration or potential contaminants.^Pf

2VAC5-585-390. Ice.*

Ice for use as a food or a cooling medium shall be made from drinking water.^P

2VAC5-585-400. Shucked shellfish, packaging and identification.

A. Raw shucked shellfish shall be obtained in nonreturnable packages that bear a legible label that identifies the:^Pf

1. Name, address, and certification number of the shucker, packer, or repacker of the molluscan shellfish;^Pf and

2. The "sell by" or "best if used by" date for packages with a capacity of less than one-half gallon (1.87 L) (1.89 L) or the date shucked for packages with a capacity of one-half gallon (1.87 L) (1.89 L) or more.^Pf

B. A package of raw shucked shellfish that does not bear a label or which that bears a label that does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D, Specific Administrative Decisions Regarding Interstate Shipments.

2VAC5-585-410. Shellstock identification.*

A. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by the harvester and each dealer that depurates, ships, or reships the shellstock, as specified in the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish (2007), [ 2011 2013 ] Revision, (U.S. Food and Drug Administration) and that list: on each dealer's tag or label the following information in the following order:^Pf

1. Except as specified under subsection C of this section, on the harvester's tag or label, the following information in the following order:

a. The harvester's identification number that is assigned by the shellfish control authority;

b. The date of harvesting;

c. The most precise identification of the harvest location or aquaculture site that is practicable based on the system of harvest area designations that is in use by the shellfish control authority and including the abbreviation of the name of the state or country in which the shellfish are harvested;

d. The type and quantity of shellfish; and

e. The following statement in bold, capitalized type: "This tag is required to be attached until container is empty or retagged and thereafter kept on file for 90 days"; and

2. Except as specified under subsection D of this section, on each dealer's tag or label, the following information in the following order:

a. 1. The dealer's name and address, and the certification number assigned by the shellfish control authority;^Pf

b. 2. The original shipper's certification number [ including the abbreviation of the name of the state or country in which the shellfish are harvested ];^Pf

c. The same information as specified for a harvester's tag under subdivisions 1 b through d of this subsection; and 3. The harvest date, or if depurated, the date of depuration processing, or if wet stored, the original harvest date and the final harvest date [ , which is the date removed from wet storage ];^Pf

4. If wet stored or depurated, the wet storage or depuration cycle or lot number. The wet storage lot number shall begin with the letter "w";^Pf

5. The harvest area including the initials of the state of harvest;^Pf

6. The type and quantity of shellstock;^Pf

d. 7. The following statement in bold, capitalized type: " "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS";^Pf and

8. A consumer advisory as specified in 2VAC5-585-930.

B. A container of shellstock that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D, Specific Administrative Decisions Regarding Interstate Shipments and § 28.2-801 of the Code of Virginia.

C. If a place is provided on the harvester's tag or label for a dealer's name, address, and certification number, the dealer's information shall be listed first.

D. If the harvester's tag or label is designed to accommodate each dealer's identification as specified under subdivisions A 2 a and b of this section, individual dealer tags or labels need not be provided.

2VAC5-585-430. Molluscan shellfish; original container.

A. Except as specified in subsections B and C through D of this section, molluscan shellfish may not be removed from the container in which they were are received other than immediately before sale or preparation for service.

B. For display purposes, shellstock may be removed from the container in which they are received, displayed on drained ice, or held in a display container, and a quantity specified by a consumer may be removed from the display or display container and provided to the consumer if:

1. The source of the shellstock on display is identified as specified under 2VAC5-585-410 and recorded as specified under 2VAC5-585-440; and

2. The shellstock are protected from contamination.

C. Shucked shellfish may be removed from the container in which they were received and held in a display container from which individual servings are dispensed upon a consumer's request if:

1. The labeling information for the shellfish on display as specified under 2VAC5-585-400 is retained and correlated to the date when, or dates during which, the shellfish are sold or served; and

2. The shellfish are protected from contamination.

D. Shucked shellfish may be removed from the container in which they were received and repacked in consumer self-service containers where allowed by law if:

1. The labeling information for the shellfish is on each consumer self-service container as specified under 2VAC5-585-400 and 2VAC5-585-900 A and B 1 through 5;

2. The labeling information as specified under 2VAC5-585-400 is retained and correlated with the date when, or dates during which, the shellfish are sold or served;

3. The labeling information and dates specified under subdivision 2 of this subsection are maintained for 90 days; and

4. The shellfish are protected from contamination.

2VAC5-585-440. Shellstock; maintaining identification.*

A. Except as specified under subdivision C 2 of this section, shellstock tags or labels shall remain attached to the container in which the shellstock are received until the container is empty.^Pf

B. The date when the last shellstock from the container is sold or served shall be recorded on the tag or label.^Pf

C. The identity of the source of shellfish shellstock that are sold or served shall be maintained by retaining shellstock tags or labels for 90 calendar days from the date that is recorded on the tag or label as specified in subsection B of this section by:^Pf

1. Using an approved recordkeeping system that keeps the tags or labels in chronological order correlated to the date that is recorded on the tag or label, as specified under subsection B of this section;^Pf and

2. If shellstock are removed from its tagged or labeled container:

a. Preserving source identification by using a recordkeeping system as specified under subdivision 1 of this subsection;^Pf and

b. Ensuring that shellstock from one tagged or labeled container are not commingled with shellstock from another container with different certification numbers; different harvest dates; or different growing areas as identified on the tag or label before being ordered by the consumer.^Pf

Article 3
Protection from Contamination after Receiving

2VAC5-585-450. Preventing contamination from hands.*

A. Food employees shall wash their hands as specified under 2VAC5-585-140.

B. Except when washing fruits and vegetables as specified under 2VAC5-585-510 or as specified in subsection C subsections D and E of this section, food employees may not contact exposed, ready-to-eat food with their bare hands and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment.^P

C. Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.^{S Pf}

D. Subsection B of this section does not apply to a food employee who contacts exposed, ready-to-eat food with bare hands at the time the ready-to-eat food is being added as an ingredient to food that:

1. Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the food to the minimum temperatures specified in 2VAC5-585-700 A and B or 2VAC5-585-710; or

2. Does not contain a raw animal food but is to be cooked in the food establishment to heat all parts of the food to a temperature of at least 145°F (63°C).

E. Food employees not serving a highly susceptible population may contact exposed, ready-to-eat food with their bare hands if:

1. The operator obtains prior approval from the regulatory authority department;

2. Written procedures are maintained in the food establishment and made available to the regulatory authority department upon request that include:

a. For each bare hand contact procedure, a listing of the specific ready-to-eat foods that are touched by bare hands; and

b. Diagrams and other information showing that handwashing facilities, installed, located, equipped, and maintained as specified under 2VAC5-585-2230, 2VAC5-585-2280, 2VAC5-585-2310, 2VAC5-585-3020, 2VAC5-585-3030, and 2VAC5-585-3045, are in an easily accessible location and in close proximity to the work station where the bare hand contact procedure is conducted;

3. A written employee health policy that details how the food establishment complies with 2VAC5-585-80, 2VAC5-585-90, and 2VAC5-585-100 including:

a. Documentation that the food employees and conditional employees acknowledge that they are informed to report information about their health and activities as they relate to gastrointestinal symptoms and diseases that are transmittable through food as specified under 2VAC5-585-80 A;

b. Documentation that food employees and conditional employees acknowledge their responsibilities as specified under 2VAC5-585-80 E and F; and

c. Documentation that the person in charge acknowledges the responsibilities as specified under 2VAC5-585-80 B, C, and D, 2VAC5-585-90, and 2VAC5-585-100;

4. Documentation that the food employees acknowledge that they have received training in:

a. The risks of contacting the specific ready-to-eat foods with their bare hands,

b. Proper handwashing as specified under 2VAC5-585-140,

c. When to wash their hands as specified under 2VAC5-585-160,

d. Where to wash their hands as specified under 2VAC5-585-170,

e. Proper fingernail maintenance as specified under 2VAC5-585-190,

f. Prohibition of jewelry as specified under 2VAC5-585-200, and

g. Good hygienic practices as specified under 2VAC5-585-220 and 2VAC5-585-230;

5. Documentation that hands are washed before food preparation and as necessary to prevent cross-contamination by food employees as specified under 2VAC5-585-130, 2VAC5-585-140, 2VAC5-585-160, and 2VAC5-585-170 during all hours of operation when the specific ready-to-eat foods are prepared;

6. Documentation that food employees contacting ready-to-eat food with bare hands use two or more of the following control measures to provide additional safeguards to hazards associated with bare hand contact:

a. Double handwashing,

b. Nail brushes,

c. A hand antiseptic after handwashing as specified under 2VAC5-585-180,

d. Incentive programs such as paid sick leave that assist or encourage food employees not to work when they are ill, or

e. Other control measures approved by the regulatory authority department; and

7. Documentation that corrective action is taken when subdivisions 1 through 6 of this subsection are not followed.

2VAC5-585-460. Preventing contamination when tasting.*

A food employee may not use a utensil more than once to taste food that is to be sold or served.^P

2VAC5-585-470. Packaged and unpackaged food - separation, packaging, and segregation.*

A. Food shall be protected from cross contamination by:

1. Separating Except as specified in subdivision 1 c of this subsection, separating raw animal foods during storage, preparation, holding, and display from:

a. Raw ready-to-eat food including other raw animal food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as fruits and vegetables; and^P

b. Cooked ready-to-eat food;^P and

c. Frozen, commercially processed and packaged raw animal food may be stored or displayed with or above frozen, commercially processed and packaged, ready-to-eat food;

2. Except when combined as ingredients, separating types of raw animal foods from each other such as beef, fish, lamb, pork, and poultry during storage, preparation, holding, and display by:

a. Using separate equipment for each type or arranging each type of food in equipment so that cross contamination of one type with another is prevented; and ^P

b. Arranging each type of food in equipment so that cross contamination of one type with another is prevented;^P and

c. Preparing each type of food at different times or in separate areas;^P

3. Cleaning equipment and utensils as specified under 2VAC5-585-1780 A and sanitizing as specified under 2VAC5-585-1900;

4. Except as specified in subdivision B 2 of 2VAC5-585-810 and subsection B of this section, storing the food in packages, covered containers, or wrappings;

5. Cleaning hermetically sealed containers of food of visible soil before opening;

6. Protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened;

7. Storing damaged, spoiled, or recalled food being held in the food establishment as specified under 2VAC5-585-3150; and

8. Separating fruits and vegetables before they are washed as specified under 2VAC5-585-510 from ready-to-eat food.

B. Subdivision A 4 of this section does not apply to:

1. Whole, uncut, raw fruits and vegetables and nuts in the shell, that require peeling or hulling before consumption;

2. Primal cuts, quarters, or sides of raw meat or slab bacon that are hung on clean, sanitized hooks or placed on clean, sanitized racks;

3. Whole, uncut, processed meats such as country hams, and smoked or cured sausages that are placed on clean, sanitized racks;

4. Food being cooled as specified under 2VAC5-585-810 B 2; or

5. Shellstock.

2VAC5-585-480. Food storage containers; identified with common name of food.

Working containers holding food or food ingredients that are removed from their original packages for use in the food establishment, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar, shall be identified with the common name of the food (in English and the common language of the food workers) except that containers holding food that can be readily and unmistakably recognized such as dry pasta need not be identified. Except for containers holding food that can be readily and unmistakably recognized, such as dry pasta, working containers holding food or food ingredients that are removed from their original packages for use in the food establishment, such as cooking oils, flour, herbs, potato flakes, salt, spices, and sugar, shall be identified with the common name of the food.

2VAC5-585-490. Pasteurized eggs; substitute for raw shell eggs for certain recipes and populations.*

Pasteurized eggs or egg products shall be substituted for raw shell eggs in the preparation of foods such as Caesar salad, hollandaise or béarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and egg-fortified beverages that are not:^P

1. Cooked as specified under subdivisions subdivision A 1 or 2 of 2VAC5-585-700;^P or

2. Included in 2VAC5-585-700 D.^P

2VAC5-585-500. Protection from unapproved additives.*

A. Food shall be protected from contamination that may result from the addition of, as specified in 2VAC5-585-350:

1. Unsafe or unapproved food or color additives;^P and

2. Unsafe or unapproved levels of approved food and color additives.^P

B. A food employee may not:

1. Apply sulfiting agents to fresh fruits and vegetables intended for raw consumption or to a food considered to be a good source of vitamin B1 B₁;^P or

2. Except for grapes, serve or sell food specified in subdivision 1 of this subsection that is treated with sulfiting agents before receipt by the food establishment.^P

2VAC5-585-510. Washing fruits and vegetables.

A. Raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready-to-eat form except as specified in subsection B of this section and except that whole, raw fruits and vegetables that are intended for washing by the consumer before consumption need not be washed before they are sold. Except as specified in subsection B of this section and except for whole, raw fruits and vegetables that are intended for washing by the consumer before consumption, raw fruits and vegetables shall be thoroughly washed in water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready-to-eat form.

B. Fruits and vegetables may be washed by using chemicals as specified under 2VAC5-585-3390.

C. Devices used for onsite generation of chemicals meeting the requirements specified in 21 CFR 173.315 for the washing of raw, whole fruits and vegetables shall be used in accordance with the manufacturer's instructions.^Pf

2VAC5-585-520. Ice used as exterior coolant prohibited as ingredient.

After use as a medium for cooling the exterior surfaces of food such as melons or fish, packaged foods such as canned beverages, or cooling coils and tubes of equipment, ice may not be used as food.^P

2VAC5-585-530. Storage or display of food in contact with water or ice.

A. Packaged food may not be stored in direct contact with ice or water if the food is subject to the entry of water because of the nature of its packaging, wrapping, or container or its positioning in the ice or water.

B. Except as specified in subsections C and D of this section, unpackaged food may not be stored in direct contact with undrained ice.

C. Whole, raw fruits or vegetables; cut, raw vegetables such as celery or carrot sticks or cut potatoes; and tofu may be immersed in ice or water.

D. Raw chicken poultry and raw fish that are received immersed in ice in shipping containers may remain in that condition while in storage awaiting preparation, display, service, or sale.

2VAC5-585-540. Food contact with equipment and utensils.*

Food shall only contact surfaces of:

1. Equipment and utensils that are cleaned as specified under 2VAC5-585-1770 through 2VAC5-595-1870 2VAC5-585-1860 and sanitized as specified under 2VAC5-585-1890 2VAC5-585-1885 through 2VAC5-585-1900; or^P

2. Single-service and single-use articles; or ^P

3. Linens, such as cloth napkins, as specified under 2VAC5-585-560, that are laundered as specified under 2VAC5-585-1910 through 2VAC5-585-1950.^P

2VAC5-585-550. In-use utensils, between-use storage.

During pauses in food preparation or dispensing, food preparation and dispensing utensils shall be stored:

1. Except as specified under subdivision 2 of this section, in the food with their handles above the top of the food and the container;

2. In food that is not potentially hazardous time/temperature control for safety food with their handles above the top of the food within containers or equipment that can be closed, such as bins of sugar, flour, or cinnamon;

3. On a clean portion of the food preparation table or cooking equipment only if the in-use utensil and the food-contact surface of the food preparation table or cooking equipment are cleaned and sanitized at a frequency specified under 2VAC5-585-1780 and 2VAC5-585-1890;

4. In running water of sufficient velocity to flush particulates to the drain, if used with moist food such as ice cream or mashed potatoes;

5. In a clean, protected location if the utensils, such as ice scoops, are used only with a food that is not potentially hazardous time/temperature control for safety food; or

6. In a container of water if the water is maintained at a temperature of at least 135°F (57°C) and the container is cleaned at a frequency specified under 2VAC5-585-1780 D 7.

2VAC5-585-560. Linens and napkins, use limitation.

Linens and napkins, such as cloth napkins, may not be used in contact with food unless they are used to line a container for the service of foods and the linens and napkins are replaced each time the container is refilled for a new customer consumer.

2VAC5-585-570. Wiping cloths, use limitation.

A. Cloths in use for wiping food spills from tableware and carry-out containers that occur as food is being served shall be:

1. Maintained dry; and

2. Used for no other purpose.

B. Cloths in use for wiping counters and other equipment surfaces shall be:

1. Held between uses in a chemical sanitizer solution at a concentration specified in 2VAC5-585-3380 2VAC5-585-1700; and

2. Laundered daily as specified under 2VAC5-585-1920 D.

C. Cloths in use for wiping surfaces in contact with raw animal foods shall be kept separate from other cloths used for other purposes.

D. Dry wiping cloths and the chemical sanitizing solutions specified in subdivision B 1 of this section in which wet wiping cloths are held between uses shall be free of food debris and visible soil.

E. Containers of chemical sanitizing solutions specified in subdivision B 1 of this section in which wet wiping cloths are held between uses shall be stored off the floor and used in a manner that prevents contamination of food, equipment, utensils, linens, single-service, or single-use articles.

F. Single-use disposable sanitizer wipes shall be used in accordance with EPA-approved manufacturer's label use instructions.

2VAC5-585-580. Gloves, use limitation.

A. If used, single-use gloves shall be used for only one task such as working with ready-to-eat food or with raw animal food, used for no other purpose, and discarded when damaged or soiled, or when interruptions occur in the operation.^P

B. Except as specified in subsection C of this section, slash-resistant gloves that are used to protect the hands during operations requiring cutting shall be used in direct contact only with food that is subsequently cooked as specified under 2VAC5-585-700 through 2VAC5-585-765 such as frozen food or a primal cut of meat.

C. Slash-resistant gloves may be used with ready-to-eat food that will not be subsequently cooked if the slash-resistant gloves have a smooth, durable, and nonabsorbent outer surface; or if the slash-resistant gloves are covered with a smooth, durable, nonabsorbent glove, or a single-use glove.

D. Cloth gloves may not be used in direct contact with food unless the food is subsequently cooked as required under 2VAC5-585-700 through 2VAC5-585-765 such as frozen food or a primal cut of meat.

2VAC5-585-590. Using clean tableware for second portions and refills.

A. Except for refilling a consumer's drinking cup or container without contact between the pouring utensil and the lip contact area of the drinking cup or container, food employees may not use tableware, including single-service articles, soiled by the consumer to provide second portions or refills.

B. Except as specified in subsection C of this section, self-service consumers may not be allowed to use soiled tableware, including single-service articles, to obtain additional food from the display and serving equipment.

C. Cups and glasses Drinking cups and containers may be reused by self-service consumers or food employees if refilling is a contamination-free process as specified under subdivisions 1, 2, and 4 of 2VAC5-585-1230.

2VAC5-585-600. Refilling returnables.

A. A take-home food container Except as specified in subsections B through E of this section, empty containers returned to a food establishment may not be refilled at a food establishment with a potentially hazardous food for cleaning and refilling with food shall be cleaned and refilled in a regulated food processing plant.^P

B. Except as specified in subsection C of this section, a A take-home food container refilled with food that is not potentially hazardous shall be cleaned as specified under 2VAC5-585-1870 B. returned to a food establishment may be refilled at a food establishment with food if the food container is:

1. Designed and constructed for reuse and in accordance with the requirements specified under 2VAC5-585-960 through 2VAC5-585-1435;^P

2. One that was initially provided by the food establishment to the consumer, either empty or filled with food by the food establishment, for the purpose of being returned for reuse;

3. Returned to the food establishment by the consumer after use;

4. Subject to the following steps before being refilled with food:

a. Cleaned as specified under 2VAC5-585-1770 through 2VAC5-585-1860;

b. Sanitized as specified under 2VAC5-585-1885 through 2VAC5-585-1900;^P and

c. Visually inspected by a food employee to verify that the container, as returned, meets the requirements specified under 2VAC5-585-960 through 2VAC5-585-1435^P.

C. Personal take-out beverage containers, such as thermally insulated bottles, nonspill coffee cups and promotional beverage glasses, may be refilled by employees or the consumer if refilling is a contamination-free process as specified under subdivisions 1, 2 and 4 of 2VAC5-585-1230. A take-home food container returned to a food establishment may be refilled at a food establishment with beverage if:

1. The beverage is not a time/temperature control for safety food;

2. The design of the container and of the rinsing equipment and the nature of the beverage, when considered together, allow effective cleaning at home or in the food establishment;

3. Facilities for rinsing before refilling returned containers with fresh, hot water that is under pressure and not recirculated are provided as part of the dispensing system;

4. The consumer-owned container returned to the food establishment for refilling is refilled for sale or service only to the same consumer; and

5. The container is refilled by:

a. An employee of the food establishment; or

b. The owner of the container if the beverage system includes a contamination-free transfer process as specified under subdivisions 1, 2, and 4 of 2VAC5-585-1230 that cannot be bypassed by the container owner.

D. Consumer-owned, personal take-out beverage containers, such as thermally insulated bottles, nonspill coffee cups, and promotional beverage glasses, may be refilled by employees or the consumer if refilling is a contamination-free process as specified under subdivisions 1, 2, and 4 of 2VAC5-585-1230.

E. Consumer-owned containers that are not food specific may be filled at a water vending machine or system.

2VAC5-585-620. Food storage; prohibited areas.

Food may not be stored:

1. In locker rooms;

2. In toilet rooms or their vestibules;

3. In dressing rooms;

4. In garbage rooms;

5. In mechanical rooms;

6. Under sewer lines that are not shielded to intercept potential drips;

7. Under leaking water lines, including leaking automatic fire sprinkler heads, or under lines on which water has condensed;

8. Under open stairwells; or

9. Under other sources of contamination.

2VAC5-585-630. Vended potentially hazardous time/temperature control for safety food; original container.

Potentially hazardous Time/temperature control for safety food dispensed through a vending machine shall be in the package in which it was placed at the food establishment or food processing plant at which it was prepared.

2VAC5-585-650. Food display.

Except for nuts in the shell and whole, raw fruits and vegetables that are intended for hulling, peeling, or washing by the consumer before consumption, food on display shall be protected from contamination by the use of packaging; counter, service line, or salad bar food guards; display cases; or other effective means.^P

2VAC5-585-660. Condiments; protection.

A. Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected food displays provided with the proper utensils, original containers designed for dispensing, or individual packages or portions.

B. Condiments at a vending machine location shall be in individual packages or provided in dispensers that are filled at a an approved location that is approved by the department, such as the food establishment that provides food to the vending machine location, a food processing plant that is regulated by the agency that has jurisdiction over the operation, or a properly equipped facility that is located on the site of the vending machine location.

2VAC5-585-670. Consumer self-service operations.*

A. Raw, unpackaged animal food, such as beef, lamb, pork, poultry, and fish may not be offered for consumer self-service.^P This subsection does not apply to:

1. Consumer self-service of ready-to-eat foods at buffets or salad bars that serve foods such as sushi or raw shellfish;

2. Ready-to-cook individual portions for immediate cooking and consumption on the premises such as consumer-cooked meats or consumer-selected ingredients for Mongolian barbecue; or

3. Raw, frozen, shell-on shrimp or lobster.

B. Consumer self-service operations for ready-to-eat foods shall be provided with suitable utensils or effective dispensing methods that protect the food from contamination.^Pf

C. Consumer self-service operations such as buffets and salad bars shall be monitored by food employees trained in safe operating procedures.^{N Pf}

2VAC5-585-680. Returned food and reservice of food.*

A. Except as specified under subsection B of this section, after being served or sold and in the possession of a consumer, food that is unused or returned by the consumer may not be offered as food for human consumption.^P

B. Except as specified in subdivision 8 7 of 2VAC5-585-950, a container of food that is not potentially hazardous (time/temperature time/temperature control for safety food) food may be re-served from one consumer to another if:

1. The food is dispensed so that it is protected from contamination and the container is closed between uses such as a narrow-neck bottle containing catsup, steak sauce, or wine; or

2. The food, such as crackers, salt, or pepper, is in an unopened original package and is maintained in sound condition.

Article 4
Destruction of Organisms of Public Health Concern

2VAC5-585-700. Raw animal foods.*

A. Except as specified in subsections B, C, and D of this section, raw animal foods such as eggs, fish, meat, poultry, and foods containing these raw animal foods shall be cooked to heat all parts of the food to a temperature and for a time that complies with one of the following methods based on the food that is being cooked:

1. 145°F (63°C) or above for 15 seconds for:^P

a. Raw shell eggs that are broken and prepared in response to a consumer's order and for immediate service;^P and

b. Except as specified under subdivisions A 2 and 3 and subsections B and C of this section, fish and meat including game animals commercially raised for food and under a voluntary inspection program as specified under 2VAC5-585-330 A 1 and game animals under a voluntary inspection program as specified under 2VAC5-585-330 A 2;^P

2. 155°F (68°C) for 15 seconds or the temperature specified in the following chart that corresponds to the holding time for ratites, mechanically tenderized, and injected meats; the following if they are comminuted: fish, meat, game animals commercially raised for food and under a voluntary inspection program as specified under 2VAC5-585-330 A 1, and game animals under a voluntary inspection program as specified under 2VAC5-585-330 A 2; and raw eggs that are not prepared as specified under subdivision A 1 a of this section:^P

Minimum
Temperature °F (°C)	Time
145 (63)	3 minutes
150 (66)	1 minute
158 (70)	<1 second (instantaneous)

3. 165°F (74°C) or above for 15 seconds for poultry, baluts, wild game animals as specified under 2VAC5-585-330 A 2 and 3, stuffed fish, stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites, or stuffing containing fish, meat, or poultry, or ratites.^P

B. Whole meat roasts including beef, corned beef, lamb, pork, and cured pork roasts such as ham shall be cooked:

1. In an oven that is preheated to the temperature specified for the roast's weight in the following chart and that is held at that temperature;^Pf and

Oven Type	Oven Temperature Based on Roast Weight
	Less than 10 lbs (4.5 kg)	10 lbs (4.5 kg) or more
Still Dry	350°F (177°C) or more	250°F (121°C) or more
Convection	325°F (163°C) or more	250°F (121°C) or more
High Humidity1	250°F (121°C) or less	250°F (121°C) or less
1Relative humidity greater than 90% for at least one hour as measured in the cooking chamber or exit of the oven; or in a moisture-impermeable bag that provides 100% humidity

2. As specified in the following chart, to heat all parts of the food to a temperature and for the holding time that corresponds to that temperature.^P

Temperature °F (°C)	Time1 in Minutes	Temperature °F (°C)	Time1 in Seconds
130 (54.4)	112	147 (63.9)	134
131 (55.0)	89	149 (65.0)	85
133 (56.1)	56	151 (66.1)	54
135 (57.2)	36	153 (67.2)	34
136 (57.8)	28	155 (68.3)	22
138 (58.9)	18	157 (69.4)	14
140 (60.0)	12	158 (70.0)	0
142 (61.1)	8
144 (62.2)	5
145 (62.8)	4
1Holding time may include postoven heat rise.

C. A raw or undercooked whole-muscle, intact beef steak may be served or offered for sale in a ready-to-eat form if:

1. The food establishment serves a population that is not a highly susceptible population;

2. The steak is labeled, as specified under 2VAC5-585-270 E, to indicate that it meets the definition of "whole-muscle, intact beef"; and

3. The steak is cooked on both the top and bottom to a surface temperature of 145°F (63°C) or above and a cooked color change is achieved on all external surfaces.

D. A raw animal food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare, or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, intact beef steaks as specified in subsection C of this section, may be served or offered for sale upon consumer request or selection in a ready-to-eat form if:

1. As specified under subdivisions 3 a and 3 b of 2VAC5-585-950, the food establishment serves a population that is not a highly susceptible population; and

2. The food, if served or offered for service by consumer selection from a children's menu, does not contain comminuted meat;^Pf and

2. 3. The consumer is informed as specified under 2VAC5-585-930 that to ensure its safety, the food should be cooked as specified under subsection A or B of this section; or

3. 4. The department grants a variance from subsection A or B of this section as specified in 2VAC5-585-3540 based on a HACCP plan that:

a. Is submitted by the operator and approved as specified under 2VAC5-585-3541;

b. Documents scientific data or other information that shows showing that a lesser time and temperature regimen results in a safe food; and

c. Verifies that equipment and procedures for food preparation and training of food employees at the food establishment meet the conditions of the variance.

2VAC5-585-710. Microwave cooking.*

Raw animal foods cooked in a microwave oven shall be:

1. Rotated or stirred throughout or midway during cooking to compensate for uneven distribution of heat;

2. Covered to retain surface moisture;

3. Heated to a temperature of at least 165°F (74°C) in all parts of the food;^P and

4. Allowed to stand covered for two minutes after cooking to obtain temperature equilibrium.

2VAC5-585-720. Plant food cooking for hot holding.

Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 135°F (57°C).^Pf

2VAC5-585-725. Noncontinuous cooking of raw animal foods.

Raw animal foods that are cooked using a noncontinuous cooking process shall be:

1. Subject to an initial heating process that is no longer than 60 minutes in duration;^P

2. Immediately after initial heating, cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food under 2VAC5-585-800 A;^P

3. After cooling, held frozen or cold as specified for time/temperature control for safety food under 2VAC5-585-820 A 2;^P

4. Prior to sale or service, cooked using a process that heats all parts of the food to a temperature and for a time as designated in 2VAC5-585-700 A through C;^P

5. Cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food under 2VAC5-585-800 A if not either hot held as specified under 2VAC5-585-820 A 1, served immediately, or held using time as a public health control as specified under 2VAC5-585-850 after complete cooking;^P and

6. Prepared and stored according to written procedures that:

a. Have obtained prior approval from the department;^Pf

b. Are maintained in the food establishment and are available to the department upon request;^Pf

c. Describe how the requirements specified under subdivisions 1 through 5 of this section are to be monitored and documented by the operator and the corrective actions to be taken if the requirements are not met;^Pf

d. Describe how the foods, after initial heating but prior to complete cooking, are to be marked or otherwise identified as foods that must be cooked as specified under subdivision 4 of this section prior to being offered for sale or service;^Pf and

e. Describe how the foods, after initial heating but prior to cooking as specified in subdivision 4 of this section, are to be separated from ready-to-eat foods as specified under 2VAC5-585-470 A.^Pf

2VAC5-585-730. Parasite destruction.*

A. Except as specified in subsection B of this section, before service or sale in ready-to-eat form, raw, raw-marinated, partially cooked, or marinated-partially cooked fish shall be:

1. Frozen and stored at a temperature of -4°F (-20°C) or below for a minimum of 168 hours (seven days) in a freezer;^P

2. Frozen at -31°F (-35°C) or below until solid and stored at -31°F (-35°C) or below for a minimum of 15 hours;^P or

3. Frozen at -31°F (-35°C) or below until solid and stored at -4°F (-20°C) or below for a minimum of 24 hours.^P

B. Subsection A of this section does not apply to:

1. Molluscan shellfish,;

2. A scallop product consisting only of the shucked abductor muscle;

3. Tuna of the species Thunnus alalunga, Thunnus albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii (Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or Thunnus thynnus (Bluefin, Northern); or

3. 4. Aquacultured fish, such as salmon, that:

a. If raised in open water, are raised in net pens, or

b. Are raised in land-based operations such as ponds or tanks, and

c. Are fed formulated feed, such as pellets, that contains no live parasites infective to the aquacultured fish. or

5. Fish eggs that have been removed from the skein and rinsed.

2VAC5-585-740. Records; creation and retention.

A. Except as specified in 2VAC5-585-730 B and subsection B of this section, if raw, marinated, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, the person in charge shall record the freezing temperature and time to which the fish are subjected and shall retain the records at the food establishment for 90 calendar days beyond the time of service or sale of the fish.^Pf

B. If the fish are frozen by a supplier, a written agreement or statement from the supplier stipulating that the fish supplied are frozen to a temperature and for a time specified under 2VAC5-585-730 may substitute for the records specified under subsection A of this section.

C. If raw, raw-marinated, partially cooked, or marinated-partially cooked fish are served or sold in ready-to-eat form, and the fish are raised and fed as specified in 2VAC5-585-730 B 3 4, a written agreement or statement from the supplier or aquaculturist stipulating that the fish were raised and fed as specified in 2VAC5-585-730 B 3 4 shall be obtained by the person in charge and retained in the records of the food establishment for 90 calendar days beyond the time of service or sale of the fish.^Pf

2VAC5-585-755. Preparation for immediate service.

Cooked and refrigerated food that is prepared for immediate service in response to an individual consumer order, such as a roast beef sandwich au jus, may be served at any temperature.

2VAC5-585-760. Reheating for hot holding.*

A. Except as specified under subsections B, C and E of this section, potentially hazardous food (time/temperature time/temperature control for safety food) food that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the food reach at least 165°F (74°C) for 15 seconds.^P

B. Except as specified under subsection C of this section, potentially hazardous food (time/temperature time/temperature control for safety food) food reheated in a microwave oven for hot holding shall be reheated so that all parts of the food reach a temperature of at least 165°F (74°C) and the food is rotated or stirred, covered, and allowed to stand covered for two minutes after reheating.^P

C. Ready-to-eat time/temperature control for safety food taken from a that has been commercially processed, hermetically sealed container, or from an intact package from and packaged in a food processing plant that is inspected by the food regulatory authority that has jurisdiction over the plant, shall be heated to a temperature of at least 135°F (57°C) when being reheated for hot holding.^P

D. Reheating for hot holding as specified under subsections A, B, and C of this section shall be done rapidly and the time the food is between the temperature specified under 2VAC5-585-820 A 2 41°F (5°C) and the temperatures specified under subsections A through, B and C of this section may not exceed two hours.^P

E. Remaining unsliced portions of meat roasts that are cooked as specified under 2VAC5-585-700 B may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified under 2VAC5-585-700 B.

2VAC5-585-765. Treating juice.

Juice packaged in a food establishment shall be:

1. Treated under a HACCP plan as specified in [ subdivisions 2 through 5 of 2VAC5-585-3610 2VAC5-585-3630 ] to attain a 5-log reduction, which is equal to a 99.999% reduction, of the most resistant microorganism of public health significance;^P or

2. Labeled, if not treated to yield a 5-log reduction of the most resistant microorganism of public health significance:^Pf

a. As specified under 2VAC5-585-900;^Pf and

b. As specified in 21 CFR 101.17(g), with the phrase, following: "WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems."^Pf

2VAC5-585-780. Potentially hazardous Time/temperature control for safety food, slacking.

Frozen potentially hazardous food (time/temperature time/temperature control for safety food) food that is slacked to moderate the temperature shall be held:

1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less, or at 45°F (7°C) or less as specified under 2VAC5-585-820 A 2 b; or

2. At any temperature if the food remains frozen.

2VAC5-585-790. Thawing.

A. Except as specified in subdivision 4 of this section subsection, potentially hazardous food (time/temperature time/temperature control for safety food) food shall be thawed:

1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less, or at 45°F (7°C) or less as specified under 2VAC5-585-820 A 2 b; or

2. Completely submerged under running water:

a. At a water temperature of 70°F (21°C) or below;

b. With sufficient water velocity to agitate and float off loose particles in an overflow; and

c. For a period of time that does not allow thawed portions of ready-to-eat food to rise above 41°F (5°C), or 45°F (7°C) as specified under 2VAC5-585-820 A 2 b; or

d. For a period of time that does not allow thawed portions of a raw animal food requiring cooking as specified under 2VAC5-585-700 A or B to be above 41°F (5°C), or 45°F (7°C) as specified under 2VAC5-585-820 A 2 b, for more than four hours including:

(1) The time the food is exposed to the running water and the time needed for preparation for cooking; or

(2) The time it takes under refrigeration to lower the food temperature to 41°F (5°C), or 45°F (7°C) as specified under 2VAC5-585-820 A 2 b;

3. As part of a cooking process if the food that is frozen is:

a. Cooked as specified under 2VAC5-585-700 A or B or 2VAC5-585-710; or

b. Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process; or

4. Using any procedure if a portion of frozen ready-to-eat food is thawed and prepared for immediate service in response to an individual consumer's order.

B. Reduced oxygen packaged fish that bears a label indicating that it is to be kept frozen until time of use shall be removed from the reduced oxygen environment:

1. Prior to its thawing under refrigeration as specified in subdivision A 1 of this section; or

2. Prior to, or immediately upon completion of, its thawing using procedures specified in subdivision A 2 of this section.

2VAC5-585-800. Cooling.*

A. Cooked potentially hazardous food (time/temperature time/temperature control for safety food) food shall be cooled:

1. Within two hours, from 135°F (57°C) to 70°F (21°C);^P and

2. Within a total of six hours, from 135°F (57°C) to 41°F (5°C) or less, or to 45°F (7°C) or less as specified under 2VAC5-585-820 A 2 b.^P

B. Potentially hazardous food (time/temperature Time/temperature control for safety food) food shall be cooled within four hours to 41°F (5°C) or less, or to 45°F (7°C) or less as specified under 2VAC5-585-820 A 2 b if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna.^P

C. Except as specified in subsection D of this section, a potentially hazardous food (time/temperature time/temperature control for safety food) food received in compliance with laws allowing a temperature above 41°F (5°C) during shipment from the supplier as specified in 2VAC5-585-340 B, shall be cooled within four hours to 41°F (5°C) or less, or 45°F (7°C) or less as specified under of 2VAC5-585-820 A 2 b.^P

D. Raw shell eggs shall be received as specified under 2VAC5-585-340 C and immediately placed in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

2VAC5-585-810. Cooling methods.

A. Cooling shall be accomplished in accordance with the time and temperature criteria specified under 2VAC5-585-800 by using one or more of the following methods based on the type of food being cooled:

1. Placing the food in shallow pans;^Pf

2. Separating the food into smaller or thinner portions;^Pf

3. Using rapid cooling equipment;^Pf

4. Stirring the food in a container placed in an ice water bath;^Pf

5. Using containers that facilitate heat transfer;^Pf

6. Adding ice as an ingredient;^Pf or

7. Other effective methods.^Pf

B. When placed in cooling or cold holding equipment, food containers in which food is being cooled shall be:

1. Arranged in the equipment to provide maximum heat transfer through the container walls; and

2. Loosely covered, or uncovered if protected from overhead contamination as specified under 2VAC5-585-610 A 2, during the cooling period to facilitate heat transfer from the surface of the food.

2VAC5-585-820. Potentially hazardous Time/temperature control for safety food; hot and cold holding.*

A. Except during preparation, cooking, or cooling, or when time is used as the public health control as specified under 2VAC5-585-850, potentially hazardous food (time/temperature and except as specified under subsections B and C of this section, time/temperature control for safety food) food shall be maintained:

1. At 135°F (57°C) or above, except that roasts cooked to a temperature and for a time specified in 2VAC5-585-700 B or reheated as specified in 2VAC5-585-760 E may be held at a temperature of 130°F (54°C) or above;^P or

2. At a temperature specified in the following:

a. 41°F (5°C) or less; or

b. 45°F (7°C) or between 45°F (7°C) and 41°F (5°C) in existing refrigeration equipment that is not capable of maintaining the food at 41°F (5°C) or less if:

(1) The equipment is in place and in use in the food establishment; and

(2) Before January 1, 2012, the equipment is upgraded or replaced to maintain food at a temperature of At 41°F (5°C) or less.

B. Shell eggs Eggs that have not been treated to destroy all viable Salmonellae shall be stored in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

C. Potentially hazardous food (time/temperature Time/temperature control for safety food) food in a homogenous liquid form may be maintained outside of the temperature control requirements, as specified in subsection A of this section, while contained within specially designed equipment that complies with the design and construction requirements as specified under subdivision 5 of 2VAC5-585-1230.

2VAC5-585-830. Ready to eat Ready-to-eat, potentially hazardous time/temperature control for safety food; date marking.*

A. Except when packaging food using a reduced oxygen packaging method as specified under 2VAC5-585-870 and except as specified in subsections D and E and F of this section, refrigerated, ready-to-eat, potentially hazardous food (time/temperature time/temperature control for safety food) food prepared and held in a food establishment for more than 24 hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded based on the temperature and time combinations specified below. The day of preparation shall be counted as Day 1.

1. 41°F (5°C) or less for a maximum of seven days; or

2. 45°F (7°C) or between 41°F (5°C) and 45°F (7°C) for a maximum of four days in existing refrigeration equipment that is not capable of maintaining the food at 41°F (5°C) or less if:

a. The equipment is in place and in use in the food establishment; and

b. Before January 1, 2012, the equipment is upgraded or replaced to maintain food at a temperature of 41°F (5°C) or less. when held at a temperature of 41°F (5°C) or less for a maximum of seven days. The day of preparation shall be counted as day one.^Pf

B. Except as specified in subsections D through E, F, and G of this section, refrigerated, ready-to-eat, potentially hazardous food (time/temperature time/temperature control for safety food) food prepared and packaged by a food processing plant shall be clearly marked, at the time the original container is opened in a food establishment and if the food is held for more than 24 hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in subsection A of this section and:^Pf

1. The day the original container is opened in the food establishment shall be counted as Day 1 day one;^Pf and

2. The day or date marked by the food establishment may not exceed a manufacturer's use-by date if the manufacturer determined the use-by date based on food safety.^Pf

C. A refrigerated, ready-to-eat potentially hazardous food (time/temperature, time/temperature control for safety food) food ingredient or a portion of a refrigerated, ready-to-eat, potentially hazardous food (time/temperature time/temperature control for safety food) food that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest-prepared or first-prepared ingredient.^Pf

D. A date marking system that meets the criteria specified stated in subsections A and B of this section may include:

1. Using a method approved by the regulatory authority department for refrigerated, ready-to-eat potentially hazardous food (time/temperature, time/temperature control for safety food) food that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft-serve mix or milk in a dispensing machine;

2. Marking the date or day of preparation, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified in subsection A of this section;

3. Marking the date or day the original container is opened in a food establishment, with a procedure to discard the food on or before the last date of or day by which the food must be consumed on the premises, sold, or discarded as specified under subsection B of this section; or

4. Using calendar dates, days of the week, color-coded marks, or other effective marking methods, provided that the marking system is disclosed to the regulatory authority department upon request.

E. Subsections A and B of this section do not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer's request.

F. Subsections A and B of this section do not apply to shellstock.

G. Subsection B of this section does not apply to the following foods prepared and packaged by a food processing plant inspected by a regulatory authority:

1. Deli salads, such as ham salad, seafood salad, chicken salad, egg salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR Part 110, Current good manufacturing practice in manufacturing, packing, or holding human food;

2. Hard cheeses containing not more than 39% moisture as defined in 21 CFR Part 133, Cheeses and related cheese products, such as cheddar, gruyere, parmesan and reggiano, and romano;

3. Semi-soft cheese containing more than 39% moisture, but not more than 50% moisture, as defined in 21 CFR Part 133, Cheeses and related cheese products, such as blue, edam, gorgonzola, gouda, and Monterey jack Jack;

4. Cultured dairy products as defined in 21 CFR Part 131, Milk and cream, such as yogurt, sour cream, and buttermilk;

5. Preserved fish products, such as pickled herring and dried or salted cod, and other acidified fish products as defined in 21 CFR Part 114, Acidified foods;

6. Shelf stable, dry fermented sausages, such as pepperoni and Genoa salami that are not labeled "Keep Refrigerated" as specified in 9 CFR Part 317, Labeling, marking devices, and containers, and which retain the original casing on the product; and

7. Shelf stable salt-cured products such as prosciutto and Parma (ham) that are not labeled "Keep Refrigerated" as specified in 9 CFR Part 317, Labeling, marking devices, and containers.

2VAC5-585-840. Ready-to-eat, potentially hazardous time/temperature control for safety food; disposition.*

A. A food specified in 2VAC5-585-830 A or B shall be discarded if it:

1. Exceeds either of the temperature and time combinations combination specified in 2VAC5-585-830 A, except time that the product is frozen;^P

2. Is in a container or package that does not bear a date or day;^P or

3. Is [ appropriately inappropriately ] marked with a date or day that exceeds a temperature and time combination as specified in 2VAC5-585-830 A.^P

B. Refrigerated, ready-to-eat, potentially hazardous time/temperature control for safety food prepared in a food establishment and dispensed through a vending machine with an automatic shutoff control shall be discarded if it exceeds a temperature and time combination as specified in 2VAC5-585-830 A.^P

2VAC5-585-850. Time as a public health control.*

A. Except as specified under subsection D of this section, if time without temperature control is used as the public health control for a working supply of potentially hazardous food (time/temperature time/temperature control for safety food) food before cooking, or for ready-to-eat potentially hazardous food (time/temperature, time/temperature control for safety food) food that is displayed or held for sale or service:

1. Written procedures shall be prepared in advance, maintained in the food establishment, and made available to the regulatory authority department upon request that specify:^Pf

a. Methods of compliance with subdivision subdivisions B 1 through 4, 2, and 3 or subsection C 1 through 5 of this section;^Pf and

b. Methods of compliance with 2VAC5-585-800 for food that is prepared, cooked, and refrigerated before time is used as a public health control.^Pf

B. If time without temperature control is used as the public health control up to a maximum of 4 hours:

1. The food shall have an initial temperature of 41°F (5°C) or less when removed from cold holding temperature control, or 135°F (57°C) or greater when removed from hot-holding temperature control;^P

2. The food shall be marked or otherwise identified to indicate the time that is four hours past the point in time when the food is removed from temperature control;^Pf

3. The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within four hours from the point in time when the food is removed from temperature control;^P and

4. The food in unmarked containers or packages or marked to exceed a four-hour limit shall be discarded.^P

C. If time without temperature control is used as the public health control up to a maximum of six hours:

1. The food shall have an initial temperature of 41°F (5°C) or less when removed from temperature control and the food temperature may not exceed 70°F (21°C) within a maximum time period of six hours;^P

2. The food shall be monitored to ensure the warmest portion of the food does not exceed 70°F (21°C) during the six-hour period, unless an ambient air temperature is maintained that ensures the food does not exceed 70°F (21°C) during the six-hour holding period;^Pf

3. The food shall be marked or otherwise identified to indicate:^Pf

a. The time when the food is removed from 41°F (5°C) or less cold holding temperature control;^Pf and

b. The time that is six hours past the point in time when the food is removed from 41°F (5°C) or less cold holding temperature control;^Pf

4. The food shall be:

a. Discarded if the temperature of the foods exceeds 70°F (21°C);^P or

b. Cooked and served, served at any temperature if ready-to-eat, or discarded within a maximum of six hours from the point in time when the food is removed from 41°F (5°C) or less cold holding temperature control;^P and

5. The food in unmarked containers or packages, or marked with a time that exceeds the six-hour limit shall be discarded.^P

D. A food establishment that serves a highly susceptible population may not use time as specified under subsections subsection A, B, or C of this section as the public health control for raw eggs.

2VAC5-585-860. Variance requirement.*

A food establishment shall obtain a variance from the department as specified in 2VAC5-585-3540 and 2VAC5-585-3541 before:^Pf

1. Smoking food as a method of food preservation rather than as a method of flavor enhancement;^Pf

2. Curing food;^Pf

3. Using food additives or adding components such as vinegar:^Pf

a. As a method of food preservation rather than as a method of flavor enhancement;^Pf or

b. To render a food so that it is not potentially hazardous time/temperature control for safety food;^Pf

4. Packaging time/temperature control for safety food using a reduced oxygen packaging method except as specified under 2VAC5-585-870 where a barrier to where the growth of and toxin formation by Clostridium botulinum in addition to refrigeration exists and the growth of Listeria monocytogenes are controlled as specified under 2VAC5-585-870;^Pf

5. Operating a molluscan shellfish life-support system display tank used to store and or display shellfish that are offered for human consumption;^Pf

6. Custom processing animals that are for personal use as food and not for sale or service in a food establishment;^Pf

7. Sprouting seeds or beans;^Pf or

8. Preparing food by another method that is determined by the regulatory authority department to require a variance.^Pf

2VAC5-585-870. Reduced oxygen packaging without a variance; criteria.*

A. Except for a food establishment that obtains a variance as specified under 2VAC5-585-860 and except as specified under subsections C and E of this section, a food establishment that packages potentially hazardous food (time/temperature time/temperature control for safety food) food using a reduced oxygen packaging method shall ensure that there are at least two barriers in place to control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.^P

B. A Except as specified in subsection F of this section, a food establishment that packages potentially hazardous food (time/temperature time/temperature control for safety food) food using a reduced oxygen packaging method shall have implement a HACCP plan that contains the following information specified under subdivision subdivisions [ 2 3 ] and 4 of 2VAC5-585-3630 and that:^Pf

1. Identifies food to be packaged;^Pf

2. Except as specified in subsections C and, D, and E and as specified in subsection D of this section, requires that the packaged food shall be maintained at 41°F (5°C) or less and meet at least one of the following criteria:^Pf

a. Has an A_w of 0.91 or less,^Pf

b. Has a pH of 4.6 or less,^Pf

c. Is a meat or poultry product cured at a food processing plant regulated by the USDA using substances specified in 9 CFR 424.21, Use of food ingredients and sources of radiation, and is received in an intact package,^Pf or

d. Is a food with a high level of competing organisms such as raw meat, or raw poultry, or raw vegetables;^Pf

3. Describes how the package shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:^Pf

a. Maintain the food at 41°F (5°C) or below,^Pf and

b. Discard the food within 14 30 calendar days of its packaging if it is not served for on-premises consumption, or consumed if served or sold for off-premises consumption;^Pf

4. Limits the refrigerated shelf life to no more than 14 30 calendar days from packaging to consumption, except the time the product is maintained frozen, or the original manufacturer's "sell by" or "use by" date, whichever occurs first;^P

5. Includes operational procedures that:

a. Prohibit contacting ready-to-eat food with bare hands as specified under 2VAC5-585-450 B;^Pf

b. Identify a designated work area and the method by which:^Pf

(1) Physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross contamination,^Pf and

(2) Access to the processing equipment is limited to responsible trained personnel familiar with the potential hazards of the operation;^Pf and

c. Delineate cleaning and sanitization procedures for food contact food-contact surfaces; and^Pf

6. Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:^Pf

a. Concepts required for safe operation;^Pf

b. Equipment and facilities;^Pf and

c. Procedures specified under subdivision 5 of this subsection and 2VAC5-585-3630 D. subdivisions [ 2 3 ] and 4 of 2VAC5-585-3630;^Pf and

7. Is provided to the department prior to implementation as specified under subsection B of 2VAC5-585-3620.

C. Except for fish that is frozen before, during, and after packaging, a food establishment may not package fish using a reduced oxygen packaging method.^P

D. Except as specified in subsection subsections C and F of this section, a food establishment may package that packages time/temperature control for safety food using a cook-chill or sous-vide sous vide process without obtaining a variance if shall:

1. The food establishment implements Provide to the department prior to implementation, a HACCP plan that contains the information as specified under 2VAC5-585-3630 D subdivisions [ 2 3 ] and 4 of 2VAC5-585-3630;^Pf

2. The Ensure the food is:

a. Prepared and consumed on the premises, or prepared and consumed off the premises but within the same business entity with no distribution or sale of the bagged packaged product to another business entity or the consumer;^Pf

b. Cooked to heat all parts of the food to a temperature and for a time as specified under 2VAC5-585-700 A, B, and C;^P

c. Protected from contamination before and after cooking as specified in 2VAC5-585-450 through 2VAC5-585-690 2VAC5-585-765;^P

d. Placed in a package or bag with an oxygen barrier and sealed before cooking, or placed in a package or bag and sealed immediately after cooking, and before reaching a temperature below 135°F (57°C);^P

e. Cooled to 41°F (5°C) in the sealed package or bag as specified under 2VAC5-585-800, and subsequently;^P

(1) Cooled to 34°F (1°C) within 48 hours of reaching 41°F (5°C) and held at that temperature until consumed or discarded within 30 days after the date of preparation packaging;^P

(2) Cooled to 34°F (1°C) within 48 hours of reaching 41°F (5°C), removed from refrigeration equipment that maintains a 34°F (1°C) food temperature and then held Held at 41°F (5°C) or less for no more than 72 hours seven days, at which time the food must be consumed or discarded;^P or

(3) Cooled to 38°F (3°C) or less within 24 hours of reaching 41°F (5°C) and held there for no more than 72 hours from packaging, at which time the food must be consumed or discarded; or

(4) (3) Held frozen with no shelf-life restriction while frozen until consumed or used;^P

f. Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily;^Pf

g. If transported off-site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation;^Pf and

h. Labeled with the product name and the date packaged;^Pf and

3. The Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP plan, are maintained and are:

a. Made Make such records available to the regulatory authority department upon request;^Pf and

b. Held Hold such records for at least six months;^Pf and

4. Written Implement written operational procedures as specified under subdivision B 5 of this section and a training program as specified under subdivision B 6 of this section are implemented.^Pf

E. A Except as specified under subsection F of this section, a food establishment may package that packages cheese using a reduced oxygen packaging method without obtaining a variance shall:

1. If it limits Limit the cheeses packaged to those that are commercially manufactured in a food processing plant with no ingredients added in the food establishment and that meet the Standards of Identity as specified in 21 CFR 133.150, Hard Cheeses, 21 CFR 133.169, Pasteurized process cheese, or 21 CFR 133.187, Semi-soft cheeses;^P

2. If it has Have a HACCP plan that contains the information specified in 2VAC5-585-3630 D subdivisions [ 2 3 ] and 4 of 2VAC5-585-3630 and as specified in subdivisions B 1, B 3 a, B 5, and B 6 of this section;^Pf

3. Except as specified under subdivisions B 2, B 3 b, and B 4, complies with subsection B of this section;

4. If it labels 3. [ Labels Label ] the package on the principal display panel with a "use by" date that does not exceed 30 days from its packaging or the original manufacturer's "sell by" or "use by" date, whichever comes occurs first;^Pf and

5. If it discards 4. [ Discards Discard ] the reduced oxygen packaged cheese if it is not sold for off-premises consumption or consumed within 30 calendar days of its packaging.^Pf

F. A HACCP plan is not required when a food establishment uses a reduced oxygen packaging method to package time/temperature control for safety food that is always:

1. Labeled with the production time and date;

2. Held at 41°F (5°C) or less during refrigerated storage; and

3. Removed from its packaging in the food establishment within 48 hours after packaging.

2VAC5-585-900. Food labels.

A. Food packaged in a food establishment shall be labeled as specified in law, including 21 CFR Part 101, Food Labeling, and 9 CFR Part 317, Labeling, Marking Devices, and Containers.

B. Label information shall include:

1. The common name of the food, or absent a common name, an adequately descriptive identity statement;

2. If made from two or more ingredients, a list of ingredients and subingredients in descending order of predominance by weight, including a declaration of artificial color or flavor colors, artificial flavors, and chemical preservatives, if contained in the food;

3. An accurate declaration of the net quantity of contents;

4. The name and place of business of the manufacturer, packer, or distributor;

5. The name of the food source for each major food allergen contained in the food unless the food source is already part of the common or usual name of the respective ingredient;^Pf

6. Except as exempted in the Federal Food, Drug, and Cosmetic Act 21 USC § 343(q) (3) through (5) 21 USC § 403(g)(3) through (5), nutrition labeling as specified in 21 CFR Part 101, Food Labeling, and 9 CFR Part 317, Subpart B, Nutrition Labeling; and

7. For any salmonid fish containing canthaxanthin or astaxanthin as a color additive, the labeling of the bulk fish container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin or astaxanthin.

C. Bulk food that is available for consumer self-dispensing shall be prominently labeled with the following information in plain view of the consumer:

1. The manufacturer's or processor's label that was provided with the food; or

2. A card, sign, or other method of notification that includes the information specified under subdivisions B 1, 2, and 5 6 of this section.

D. Bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification need not be labeled if:

1. A health, nutrient content, or other claim is not made;

2. There are no state or local laws requiring labeling; and

3. The food is manufactured or prepared on the premises of the food establishment or at another food establishment or a food processing plant that is owned by the same person and is regulated by the food regulatory agency that has jurisdiction.

2VAC5-585-930. Consumer advisory; consumption of animal foods that are raw, undercooked, or not otherwise processed to eliminate pathogens.*

A. Except as specified in 2VAC5-585-700 C and 2VAC5-585-700 D 3 4 and under subdivision 3 of 2VAC5-585-950, if an animal food such as beef, eggs, fish, lamb, milk, pork, poultry, or shellfish is served or sold raw, undercooked, or without otherwise being processed to eliminate pathogens, either in ready-to-eat form or as an ingredient in another ready-to-eat food, the person in charge operator shall inform consumers of the significantly increased risk of consuming such foods by way of a disclosure and reminder, as specified in subsections B and C of this section, using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means.^Pf

B. Disclosure shall include:

1. A description of the animal-derived foods, such as "oysters on the half shell (raw oysters)," "raw-egg Caesar salad," and "hamburgers (can be cooked to order)";^Pf or

2. Identification of the animal-derived foods by asterisking them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients.^Pf

C. Reminder shall include asterisking the animal-derived foods requiring disclosure to a footnote that states:

1. Regarding the safety of these items, written information is available upon request:;^Pf

2. Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness;^Pf or

3. Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions.^Pf

Article 7
Contaminated Food

2VAC5-585-940. Discarding or reconditioning unsafe, adulterated, or contaminated food.*

A. A food that is unsafe, adulterated, or not honestly presented as specified under 2VAC5-585-260 shall be discarded or reconditioned according to an approved procedure or discarded.^P

B. Food that is not from an approved source as specified under 2VAC5-585-270 through 2VAC5-585-330 shall be discarded.^P

C. Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under 2VAC5-585-90 shall be discarded.^P

D. Food that is contaminated by food employees, consumers, or other persons through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be discarded.^P

Article 8
Special Requirements for Highly Susceptible Populations

2VAC5-585-950. Pasteurized foods, prohibited reservice, and prohibited food.*

In a food establishment that serves a highly susceptible population:

1. The following criteria apply to juice:

a. For the purposes of subdivision 1 of this section only, children who are age 9 nine years or less younger and receive food in a school, day care setting, or similar facility that provides custodial care are included as highly susceptible populations;

b. Prepackaged juice or a prepackaged beverage containing juice, that bears a warning label as specified in 21 CFR 101.17(g), Food Labeling, or a packaged juice or beverage containing juice, that bears a warning label as specified under subdivision 2 of 2VAC5-585-765 may not be served or offered for sale;^P and

c. Unpackaged juice that is prepared on the premises for service or sale in a ready-to-eat form shall be processed under a HACCP plan that contains the information specified in subdivisions [ 2 3 ] through 5 of 2VAC5-585-3630 and as specified under in 21 CFR Part 120, Hazard Analysis And Critical Control Point (HACCP) Systems, Subpart B, Pathogen Reduction, 120.24, Process Controls.^P

2. Pasteurized shell eggs or egg products shall be substituted for raw shell eggs in the preparation of:^P

a. Foods such as Caesar salad, hollandaise or béarnaise sauce, mayonnaise, meringue, eggnog, ice cream, and egg-fortified beverages;^P and

b. Except as specified in subdivision 6 of this section, recipes in which more than one egg is broken and the eggs are combined.^P

3. The following foods may not be served or offered for sale in a ready-to-eat form:^P

a. Raw animal foods such as raw fish, raw-marinated fish, raw molluscan shellfish, and steak tartare;^P

b. A partially cooked animal food such as lightly cooked fish, rare meat, soft-cooked eggs that are made from raw shell eggs, and meringue;^P and

c. Raw seed sprouts.^P

4. Food employees may not contact ready-to-eat food as specified in 2VAC5-585-450 B and E.^P

5. Time only, as the public health control as specified under 2VAC5-585-850 D, may not be used for raw eggs.^P

6. Subdivision 2 b of this section does not apply if:

a. The raw eggs are combined immediately before cooking for one consumer's serving at a single meal, cooked as specified under 2VAC5-585-700 A 1, and served immediately, such as an omelet, soufflé, or scrambled eggs;

b. The raw eggs are combined as an ingredient immediately before baking and the eggs are thoroughly cooked to a ready-to-eat form, such as a cake, muffin, or bread; or

c. The preparation of the food is conducted under a HACCP plan that:

(1) Identifies the food to be prepared;

(2) Prohibits contacting ready-to-eat food with bare hands;

(3) Includes specifications and practices that ensure:

(a) Salmonella enteritidis Enteritidis growth is controlled before and after cooking; and

(b) Salmonella enteritidis Enteritidis is destroyed by cooking the eggs according to the temperature and time specified in 2VAC5-585-700 A 2;

d. Contains the information specified under subdivision 4 of 2VAC5-585-3630 including procedures that:

(1) Control cross contamination of ready-to-eat food with raw eggs; and

(2) Delineate cleaning and sanitization procedures for food-contact surfaces; and

e. Describes the training program that ensures that the food employee responsible for the preparation of the food understands the procedures to be used.

7. Except as specified in subdivision 8 of this section, food may be re-served as specified under 2VAC5-585-680 B 1 and 2.

8. Foods may not be re-served under the following conditions:

[ 1. a. ] Any food served to patients or clients who are under contact precautions in medical isolation or quarantine, or protective environment isolation may not be re-served to others outside.

[ 2. b. ] Packages of food from any patients, clients, or other consumers should not be re-served to persons in protective environment isolation.

Part IV
Equipment, Utensils, and Linens

Article 1
Materials for Construction and Repair

2VAC5-585-960. Multiuse, characteristics.*

Materials that are used in the construction of utensils and food-contact surfaces of equipment may not allow the migration of deleterious substances or impart colors, odors, or tastes to food and under normal use conditions shall be:^P

1. Safe;^P

2. Durable, corrosion-resistant, and nonabsorbent;^N

3. Sufficient in weight and thickness to withstand repeated warewashing;^N

4. Finished to have a smooth, easily cleanable surface;^N and

5. Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition.^N

2VAC5-585-980. Lead use limitation.

A. Ceramic, china, and crystal utensils, and decorative utensils such as hand-painted ceramic or china that are used in contact with food shall be lead-free or contain levels of lead not exceeding the limits of the following utensil categories:^P

Utensil Category	Ceramic Article Description	Maximum Lead (mg/L)
Beverage Mugs, Cups, Pitchers	Coffee Mugs	0.5
Large Hollowware (excluding pitchers)	Bowls >=1.1 Liter (1.16 Quart)	1.0
Small Hollowware (excluding cups and mugs)	Bowls <1.1 Liter (1.16 Quart)	2.0
Flat Tableware	Plates, Saucers	3.0

B. Pewter alloys containing lead in excess of 0.05% may not be used as a food contact food-contact surface.^P

C. Solder and flux containing lead in excess of 0.2% may not be used as a food contact food-contact surface.

2VAC5-585-990. Copper, use limitation.*

A. Except as specified in subsections B and C of this section, copper and copper alloys such as brass may not be used in contact with a food that has a pH below 6 6.0 such as vinegar, fruit juice, or wine or for a fitting or tubing installed between a backflow prevention device and a carbonator.^P

B. Copper and copper alloys may be used in contact with beer brewing ingredients that have a pH below 6 6.0 in the prefermentation and fermentation steps of a beer brewing operation such as a brewpub or microbrewery.

C. Copper and copper alloys may be used in contact with apple butter and molasses that have a pH below 6 6.0 during the typical processing times (i.e., mixing, cooking, and cooling) for these products, as long as laboratory analysis does not reveal excessive levels of copper or other heavy metals in the finished product. Apple butter and molasses may not be held or stored in copper or copper alloys for time periods any longer than the typical processing times for these products.

2VAC5-585-1000. Galvanized metal, use limitation.*

Galvanized metal may not be used for utensils or food-contact surfaces of equipment that are used in contact with acidic food.^P

2VAC5-585-1070. Single-service and single-use, characteristics.*

Materials that are used to make single-service and single-use articles:

1. May not:

a. Allow the migration of deleterious substances;^P or

b. Impart colors, odors, or tastes to food.^N

2. Shall be:

a. Safe;^P and

b. Clean.^N

2VAC5-585-1090. Food temperature measuring devices.*

Food temperature measuring devices may not have sensors or stems constructed of glass, except that thermometers with glass sensors or stems that are encased in a shatterproof coating such as candy thermometers may be used.^P

2VAC5-585-1100. Food-contact surfaces; cleanability.*

A. Multiuse food-contact surfaces shall be:

1. Smooth;^Pf

2. Free of breaks, open seams, cracks, chips, inclusions, pits, and similar imperfections;^Pf

3. Free of sharp internal angles, corners, and crevices;^Pf

4. Finished to have smooth welds and joints;^Pf and

5. Accessible Except as specified in subsection B of this section, accessible for cleaning and inspection by one of the following methods:

a. Without being disassembled;^Pf

b. By disassembling without the use of tools;^Pf or

c. By easy disassembling with the use of handheld tools commonly available to maintenance and cleaning personnel such as screwdrivers, pliers, open-end wrenches, and Allen wrenches.^Pf

B. Subdivision A 5 of this section does not apply to cooking oil storage tanks, distribution lines for cooking oils, or beverage syrup lines or tubes.

2VAC5-585-1110. CIP equipment.

A. CIP equipment shall meet the characteristics specified under 2VAC5-585-1100 and shall be designed and constructed so that:

1. Cleaning and sanitizing solutions circulate throughout a fixed system and contact all interior food-contact surfaces;^Pf and

2. The system is self-draining or capable of being completely drained of cleaning and sanitizing solutions.

B. CIP equipment that is not designed to be disassembled for cleaning shall be designed with inspection access points to ensure that all interior food-contact surfaces throughout the fixed system are being effectively cleaned.

2VAC5-585-1120. "V" threads, use limitation.

Except for hot oil cooking or filtering equipment, "V" type threads may not be used on food-contact surfaces. This section does not apply to hot oil cooking or filtering equipment.

2VAC5-585-1180. Temperature measuring devices; food.

A. Food temperature measuring devices that are scaled only in Fahrenheit or dually scaled in Fahrenheit and Celsius shall be scaled in 2°F increments and accurate to ±2°F in the intended range of use.^Pf

B. Food temperature measuring devices that are scaled only in Celsius shall be scaled in 1°C increments accurate to ±1°C in the intended range of use.^Pf

2VAC5-585-1190. Temperature measuring devices; ambient air and water.

A. Ambient air and water temperature measuring devices that are scaled in Fahrenheit or dually scaled in Fahrenheit and Celsius and shall be designed to be easily readable and scaled in 3°F increments and accurate to ±3°F in the intended range of use.^Pf

B. Ambient air and water temperature measuring devices that are scaled only in Celsius shall be scaled in 1.5°C increments and accurate to ±1.5°C in the intended range of use.^Pf

2VAC5-585-1230. Dispensing equipment, protection of equipment and food.

In equipment that dispenses or vends liquid food or ice in unpackaged form:

1. The delivery tube, chute, orifice, and splash surfaces directly above the container receiving the food shall be designed in a manner, such as with barriers, baffles, or drip aprons, so that drips from condensation and splash are diverted from the opening of the container receiving the food.

2. The delivery tube, chute, and orifice shall be protected from manual contact such as by being recessed.

3. The delivery tube or chute and orifice of equipment used to vend liquid food or ice in unpackaged form to self-service consumers shall be designed so that the delivery tube or chute and orifice are protected from dust, insects, rodents, and other contamination by a self-closing door if the equipment is:

a. Located in an outside area that does not otherwise afford the protection of an enclosure against the rain, windblown debris, insects, rodents, and other contaminants that are present in the environment; or

b. Available for self-service during hours when it is not under the full-time supervision of a food employee.

4. The dispensing equipment actuating lever or mechanism and filling device of consumer self-service beverage dispensing equipment shall be designed to prevent contact with the lip-contact surface of glasses or cups that are refilled.

5. Dispensing equipment in which potentially hazardous food (time/temperature time/temperature control for safety food) food in homogenous liquid form is maintained outside of the temperature control requirements as specified in 2VAC5-585-820 C A shall:

a. Be specifically designed and equipped to maintain the commercial sterility of aseptically packaged food in a homogenous liquid form for a specified duration from the time of opening the packaging within the equipment;^P and

b. Conform to the requirements for this equipment as specified in NSF/ANSI 18-2006 18-2012 Manual Food and Beverage Dispensing Equipment, 2012, (NSF International).^P

2VAC5-585-1240. Vending machine, vending stage closure.

The dispensing compartment of a vending machine including a machine that is designed to vend prepackaged snack food that is not potentially hazardous time/temperature control for safety food such as chips, party mixes, and pretzels shall be equipped with a self-closing door or cover if the machine is:

1. Located in an outside area that does not otherwise afford the protection of an enclosure against the rain, windblown debris, insects, rodents, and other contaminants that are present in the environment; or

2. Available for self-service during hours when it is not under the full-time supervision of a food employee.

2VAC5-585-1300. Molluscan shellfish tanks.

A. Except as specified under subsection B of this section, molluscan shellfish life support system display tanks may not be used to display shellfish that are offered for human consumption and shall be conspicuously marked so that it is obvious to consumers that the shellfish are for display only.^P

B. Molluscan shellfish life-support system display tanks that are used to store and or display shellfish that are offered for human consumption shall be operated and maintained in accordance with a variance granted by the department as specified in 2VAC5-585-3540 and a HACCP plan that:^Pf

1. Is submitted by the person in charge operator and approved as specified under 2VAC5-585-3541;^Pf and

2. Ensures that:

a. Water used with fish other than molluscan shellfish does not flow into the molluscan tank;^Pf

b. The safety and quality of the shellfish as they were received are not compromised by the use of the tank;^Pf and

c. The identity of the source of the shellstock is retained as specified under 2VAC5-585-440.^Pf

2VAC5-585-1310. Vending machines, automatic shutoff.*

A. A machine vending potentially hazardous food (time/temperature time/temperature control for safety food) food shall have an automatic control that prevents the machine from vending food:

1. If there is a power failure, mechanical failure, or other condition that results in an internal machine temperature that cannot maintain food temperatures as specified under Part III (2VAC5-585-260 et seq.) of this chapter;^P and

2. If a condition specified under subdivision 1 of this subsection occurs, until the machine is serviced and restocked with food that has been maintained at temperatures specified under Part III.^P

B. When the automatic shutoff within a machine vending potentially hazardous food (time/temperature time/temperature control for safety food) food is activated:

1. In a refrigerated vending machine, the ambient temperature may not exceed 41°F (5°C) or 45°F (7°C) as specified under 2VAC5-585-820 A 2 for more than 30 minutes immediately after the machine is filled, serviced, or restocked;^P or

2. In a hot holding vending machine, the ambient temperature may not be less than 135°F (57°C) for more than 120 minutes immediately after the machine is filled, serviced, or restocked.^P

2VAC5-585-1320. Temperature measuring devices.

A. In a mechanically refrigerated or hot food storage unit, the sensor of a temperature measuring device shall be located to measure the air temperature or a simulated product temperature in the warmest part of a mechanically refrigerated unit and in the coolest part of a hot food storage unit.

B. Except as specified in subsection C of this section, cold or hot holding equipment used for potentially hazardous time/temperature control for safety food shall be designed to include and shall be equipped with at least one integral or affixed temperature measuring device that is located to allow easy viewing of the device's temperature display.

C. Subsection B of this section does not apply to equipment for which the placement of a temperature measuring device is not a practical means for measuring the ambient air surrounding the food because of the design, type, and use of the equipment, such as calrod units, heat lamps, cold plates, bainmaries, steam tables, insulated food transport containers, and salad bars.

D. Temperature measuring devices shall be designed to be easily readable.

E. Food temperature measuring devices and water temperature measuring devices on warewashing machines shall have a numerical scale, printed record, or digital readout in increments no greater than 2°F or 1°C in the intended range of use.^Pf

2VAC5-585-1330. Warewashing machine, data plate operating specifications.

A warewashing machine shall be provided with an easily accessible and readable data plate affixed to the machine by the manufacturer that indicates the machine's design and operating operation specifications including the:

1. Temperatures required for washing, rinsing, and sanitizing;

2. Pressure required for the fresh water sanitizing rinse unless the machine is designed to use only a pumped sanitizing rinse; and

3. Conveyor speed for conveyor machines or cycle time for stationary rack machines.

2VAC5-585-1350. Warewashing machines, temperature measuring devices.

A warewashing machine shall be equipped with a temperature measuring device that indicates the temperature of the water:

1. In each wash and rinse tank;^Pf and

2. As the water enters the hot water sanitizing final rinse manifold or in the chemical sanitizing solution tank.^Pf

2VAC5-585-1360. Manual warewashing equipment, heaters and baskets.

If hot water is used for sanitization in manual warewashing operations, the sanitizing compartment of the sink shall be:

1. Designed with an integral heating device that is capable of maintaining water at a temperature not less than 171°F (77°C);^Pf and

2. Provided with a rack or basket to allow complete immersion of equipment and utensils into the hot water.^Pf

2VAC5-585-1370. Warewashing machines, automatic dispensing of detergents and sanitizers.

A. A warewashing machine that is installed after the adoption of this regulation by the board shall be equipped to:

1. Automatically dispense detergents and sanitizers;^Pf and

2. Incorporate a visual means to verify that detergents and sanitizers are delivered or a visual or audible alarm to signal if the detergents and sanitizers are not delivered to the respective washing and sanitizing cycles.^Pf

B. Before January 1, 2012, existing warewashing equipment shall be upgraded or replaced to meet the requirements of subsection A of this section.

2VAC5-585-1435. Food equipment, certification and classification.

Food equipment that is certified or classified for sanitation by an American National Standards Institute accredited certification program is deemed to comply with the requirements of Articles 1 (2VAC5-585-960 et seq.) and 2 (2VAC5-585-1080 et seq.) of this part.

Article 3
Numbers and Capacities

2VAC5-585-1450. Cooling, heating, and holding capacities.

Equipment for cooling and heating food, and holding cold and hot food, shall be sufficient in number and capacity and capable of providing to provide food temperatures as specified under Part III (2VAC5-585-260 et seq.) of this chapter.^Pf

2VAC5-585-1460. Manual warewashing, sink compartment requirements.

A. Except as specified in subsection C of this section, a sink with at least three compartments shall be provided for manually washing, rinsing, and sanitizing equipment and utensils.^Pf

B. Sink compartments shall be large enough to accommodate immersion of the largest equipment and utensils. If equipment or utensils are too large for the warewashing sink, a warewashing machine or alternative equipment as specified in subsection C of this section shall be used.^Pf

C. Alternative manual warewashing equipment may be used when there are special cleaning needs or constraints and its use is approved. Alternative manual warewashing equipment may include:

1. High-pressure detergent sprayers;

2. Low-pressure or line-pressure spray detergent foamers;

3. Other task-specific cleaning equipment;

4. Brushes or other implements;

5. Two-compartment sinks as specified under subsections D and E of this section; or

6. Receptacles that substitute for the compartments of a multicompartment sink.

D. Before a two-compartment sink is used:

1. The operator shall have its use approved; and

2. The person in charge operator shall limit the number of kitchenware items cleaned and sanitized in the two-compartment sink, and shall limit warewashing to batch operations for cleaning kitchenware such as between cutting one type of raw meat and another or cleanup at the end of a shift, and shall:

a. Make up the cleaning and sanitizing solutions immediately before use and drain them immediately after use; and

b. Use a detergent-sanitizer to sanitize and apply the detergent-sanitizer in accordance with the manufacturer's label instructions and as specified under 2VAC5-585-1710; or

c. Use a hot water sanitization immersion step as specified under subdivision 3 of 2VAC5-585-1860.

E. A two-compartment sink may not be used for warewashing operations where cleaning and sanitizing solutions are used for a continuous or intermittent flow of kitchenware or tableware in an ongoing warewashing process.

2VAC5-585-1500. Utensils, consumer self-service.

A food dispensing utensil shall be available for each container displayed at a consumer self-service unit such as a buffet or salad bar.^Pf

2VAC5-585-1510. Food temperature measuring devices.

A. Food temperature measuring devices shall be provided and readily accessible for use in ensuring attainment and maintenance of food temperatures as specified under Part III (2VAC5-585-260 et seq.) of this chapter.^Pf

B. A temperature measuring device with a suitable small-diameter probe that is designed to measure the temperature of thin masses shall be provided and readily accessible to accurately measure the temperature in thin foods such as meat patties and fish fillets.^Pf

2VAC5-585-1520. Temperature measuring devices, manual and mechanical warewashing.

A. In manual warewashing operations, a temperature measuring device shall be provided and readily accessible for frequently measuring the washing and sanitizing temperatures.^Pf

B. In hot water mechanical warewashing operations, an irreversible registering temperature indicator shall be provided and readily accessible for measuring the utensil surface temperature.^Pf

2VAC5-585-1530. Sanitizing solutions, testing devices.

A test kit or other device that accurately measures the concentration in mg/L (ppm) of sanitizing solutions shall be provided and readily accessible for use.^Pf

 [ 2VAC5-585-1535. Cleaning agents and sanitizers; availability.

A. Cleaning agents that are used to clean equipment and utensils as specified under Article 6 (2VAC5-585-1770 et seq.) of this part shall be provided and available for use during all hours of operation.

B. Except for chemical sanitizers that are generated on site at the time of use, chemical sanitizers that are used to sanitize equipment and utensils as specified under Article 7 (2VAC5-585-1885 et seq.) of this part shall be provided and available for use during all hours of operation. ]

Article 4
Location and Installation

2VAC5-585-1540. Equipment, clothes washers and dryers, and storage cabinets, contamination prevention.

A. Except as specified in subsection B of this section, equipment, cabinets a cabinet used for the storage of food, or cabinets a cabinet used to store cleaned and sanitized equipment, utensils, laundered linens, and single-service and single-use articles may not be located:

1. In locker rooms;

2. In toilet rooms or vestibules;

3. In garbage rooms;

4. In mechanical rooms;

5. Under sewer lines that are not shielded to intercept potential drips;

6. Under leaking water lines including leaking automatic fire sprinkler heads or under lines on which water has condensed;

7. Under open stairwells; or

8. Under other sources of contamination.

B. A storage cabinet used for linens or single-service or single-use articles may be stored in a locker room.

C. If a mechanical clothes washer or dryer is provided, it shall be located only where there is no exposed food; clean equipment, utensils, and linens; unwrapped single-service and single-use articles; and (i) so that the washer or dryer is protected from contamination and (ii) only where there is no exposed food; clean equipment, utensils, and linens; or unwrapped single-service and single-use articles.

2VAC5-585-1550. Fixed equipment, spacing or sealing.

A. Equipment that is fixed because it is not easily movable shall be installed so that it is:

1. Spaced to allow access for cleaning along the sides, behind, and above the equipment;

2. Spaced from adjoining equipment, walls, and ceilings a distance of not more than 1/32 inch or one millimeter; or

3. Sealed to adjoining equipment or walls, if the equipment is exposed to spillage or seepage.

B. Counter-mounted equipment that is not easily movable shall be installed to allow cleaning of the equipment and areas underneath and around the equipment by being:

1. Sealed to the table; or

2. Elevated on legs as specified under 2VAC5-585-1560 D.

2VAC5-585-1560. Fixed equipment, elevation or sealing.

A. Except as specified in subsections B and C of this section, floor-mounted equipment that is not easily movable shall be sealed to the floor or elevated on legs that provide at least a six-inch [ (15-centimeter) (15 centimeter) ] clearance between the floor and the equipment.

B. If no part of the floor under the floor-mounted equipment is more than six inches (15 centimeters) from the point of cleaning access, the clearance space may be only four inches (10 centimeters).

C. This section does not apply to display shelving units, display refrigeration units, and display freezer units located in the consumer shopping areas of a retail food store, if the floor under the units is maintained clean.

D. Except as specified in subsection E of this section, counter-mounted equipment that is not easily movable shall be elevated on legs that provide at least a four-inch [ (10-centimeter) (10 centimeter) ] clearance between the table and the equipment.

E. The clearance space between the table and counter-mounted equipment may be:

1. Three inches (7.5 centimeters) if the horizontal distance of the table top under the equipment is no more than 20 inches (50 centimeters) from the point of access for cleaning; or

2. Two inches (5 centimeters) if the horizontal distance of the table top under the equipment is no more than three inches (7.5 centimeters) from the point of access for cleaning.

Article 5
Maintenance and Operation

2VAC5-585-1570. Good repair and proper adjustment.

A. Equipment shall be maintained in a state of repair and condition that meets the requirements specified under Articles 1 (2VAC5-585-960 et seq.) and 2 (2VAC5-585-1080 et seq.) of this part. Unused or nonfunctioning equipment shall be removed from the premises.

B. Equipment components such as doors, seals, hinges, fasteners, and kick plates shall be kept intact, tight, and adjusted in accordance with manufacturer's specifications.

C. Cutting or piercing parts of can openers shall be kept sharp to minimize the creation of metal fragments that can contaminate food when the container is opened.

2VAC5-585-1630. Warewashing equipment, cleaning agents.

When used for warewashing, the wash compartment of a sink, mechanical warewasher, or wash receptacle of alternative manual warewashing equipment as specified in 2VAC5-585-1460 C, shall contain a wash solution of soap, detergent, acid cleaner, alkaline cleaner, degreaser, abrasive cleaner, or other cleaning agent according to the cleaning agent manufacturer's label instructions.^Pf

2VAC5-585-1650. Manual warewashing equipment, wash solution temperature.

The temperature of the wash solution in manual warewashing equipment shall be maintained at not less than 110°F (43°C) or the temperature specified on the cleaning agent manufacturer's label instructions.^Pf

2VAC5-585-1660. Mechanical warewashing equipment, wash solution temperature.

A. The temperature of the wash solution in spray type warewashers that use hot water to sanitize may not be less than:

1. For a stationary rack, single temperature machine, 165°F (74°C);^Pf

2. For a stationary rack, dual temperature machine, 150°F (66°C);^Pf

3. For a single tank, conveyor, dual temperature machine, 160°F (71°C);^Pf or

4. For a multitank, conveyor, multitemperature machine, 150°F (66°C).^Pf

B. The temperature of the wash solution in spray-type warewashers that use chemicals to sanitize may not be less than 120°F (49°C).^Pf

2VAC5-585-1670. Manual warewashing equipment, hot water sanitization temperatures.*

If immersion in hot water is used for sanitizing in a manual operation, the temperature of the water shall be maintained at 171°F (77°C) or above.^P

2VAC5-585-1680. Mechanical warewashing equipment, hot water sanitization temperatures.

A. Except as specified in subsection B of this section, in a mechanical operation, the temperature of the fresh hot water sanitizing rinse as it enters the manifold may not be more than 194°F (90°C), or less than:^Pf

1. For a stationary rack, single temperature machine, 165°F (74°C);^Pf or

2. For all other machines, 180°F (82°C).^Pf

B. The maximum temperature specified under subsection A of this section does not apply to the high pressure and temperature systems with wand-type, hand-held, spraying devices used for the in-place cleaning and sanitizing of equipment such as meat saws.

2VAC5-585-1700. Manual and mechanical warewashing equipment, chemical sanitization - temperature, pH, concentration, and hardness.*

A chemical sanitizer used in a sanitizing solution for a manual or mechanical operation at exposure contact times specified under subdivision 3 of 2VAC5-585-1900 shall be listed in 40 CFR 180.940, Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions), shall be used in accordance with the EPA-approved manufacturer's label use instructions, meet the criteria specified under 2VAC5-585-3380, shall be used in accordance with the EPA-registered label use instructions,^P and shall be used as follows:

1. A chlorine solution shall have a minimum temperature based on the concentration and pH of the solution as listed in the following chart;^P

Minimum Concentration	Minimum Temperature
mg/L (ppm)	pH 10 or less °F (°C)	pH 8 8.0 or less °F (°C)
25-49	120 (49)	120 (49)
50-99	100 (38)	75 (24)
100	55 (13)	55 (13)

2. An iodine solution shall have a:

a. Minimum temperature of 75°F (24°C) 68°F (20°C);^P

b. pH of 5.0 or less or a pH no higher than the level for which the manufacturer specifies the solution is effective;^P and

c. Concentration between 12.5 mg/L(ppm) and 25 mg/L (ppm);^P

3. A quaternary ammonium compound solution shall:

a. Have a minimum temperature of 75°F (24°C);^P

b. Have a concentration as specified under 2VAC5-585-3380 and as indicated by the manufacturer's use directions included in the labeling;^P and

c. Be used only in water with 500 mg/L hardness or less or in water having a hardness no greater than specified by the manufacturer's label EPA-registered label use instructions;^P

4. If another solution of a chemical specified under subdivisions 1 through 3 of this section is used, the person in charge operator shall demonstrate to the department that the solution achieves sanitization and the use of the solution shall be approved;^P or

5. If a chemical sanitizer other than chlorine, iodine, or a quaternary ammonium compound is used, it shall be applied in accordance with the manufacturer's use directions included in the labeling. EPA-registered label use instructions;^P and

6. If a chemical sanitizer is generated by a device located on site at the food establishment, it shall be used as specified in subdivisions 1 through 4 of this section and shall be produced by a device that:

a. Complies with regulation as specified in §§ 2(q)(1) and 12 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 USC § 136(q)(1) and 7 USC § 136j);^P

b. Complies with 40 CFR 152.500 and 40 CFR 156.10;^P

c. Displays the EPA device manufacturing facility registration number on the device;^Pf and

d. Is operated and maintained in accordance with manufacturer's instructions.^Pf

2VAC5-585-1720. Warewashing equipment, determining chemical sanitizer concentration.

Concentration of the sanitizing solution shall be accurately determined by using a test kit or other device.^Pf

2VAC5-585-1730. Good repair and calibration.

A. Utensils shall be maintained in a state of repair or condition that complies with the requirements specified under Articles 1 (2VAC5-585-960 et seq.) and 2 (2VAC5-585-1080 et seq.) of this part or shall be discarded.

B. Food temperature measuring devices shall be calibrated in accordance with manufacturer's specifications as necessary to ensure their accuracy.^Pf

C. Ambient air temperature, water pressure, and water temperature measuring devices shall be maintained in good repair and be accurate within the intended range of use.

2VAC5-585-1740. Single-service and single-use articles, required use.*

A food establishment without facilities specified under Articles 6 (2VAC5-585-1770 et seq.) and 7 (2VAC5-585-1880 (2VAC5-585-1885 et seq.) of this part for cleaning and sanitizing kitchenware and tableware shall provide only single-use kitchenware, single-service articles, and single-use articles for use by food employees and single-service articles for use by consumers.^P

Article 6
Cleaning of Equipment and Utensils

2VAC5-585-1770. Equipment, food-contact surfaces, nonfood-contact surfaces, and utensils.*

A. Equipment food-contact surfaces and utensils shall be clean to sight and touch.^Pf

B. The food-contact surfaces of cooking equipment and pans shall be kept free of encrusted grease deposits and other soil accumulations.^N

C. Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.^N

2VAC5-585-1780. Equipment food-contact surfaces and utensils.*

A. Equipment food-contact surfaces and utensils shall be cleaned:

1. Except as specified in subsection B of this section, before each use with a different type of raw animal food such as beef, fish, lamb, pork, or poultry;^P

2. Each time there is a change from working with raw foods to working with ready-to-eat foods;^P

3. Between uses with raw fruits and vegetables and with potentially hazardous time/temperature control for safety food;^P

4. Before using or storing a food temperature measuring device;^P and

5. At any time during the operation when contamination may have occurred.^P

B. Subdivision A 1 of this section does not apply if the food contact food-contact surface or utensil is in contact with a succession of different raw animal foods types of raw meat and poultry each requiring a higher cooking temperature as specified under 2VAC5-585-700 than the previous food, such as preparing raw fish followed by cutting raw poultry on the same cutting board type.

C. Except as specified in subsection D of this section, if used with potentially hazardous time/temperature control for safety food, equipment food-contact surfaces and utensils shall be cleaned throughout the day at least every four hours.^P

D. Surfaces of utensils and equipment contacting potentially hazardous time/temperature control for safety food may be cleaned less frequently than every four hours if:

1. In storage, containers of potentially hazardous time/temperature control for safety food and their contents are maintained at temperatures specified under Part III (2VAC5-585-260 et seq.) of this chapter and the containers are cleaned when they are empty;

2. Utensils and equipment are used to prepare food in a refrigerated room or area that is maintained at one of the temperatures in the following chart and:

a. The utensils and equipment are cleaned at the frequency in the following chart that corresponds to the temperature; and

Temperature	Cleaning Frequency
41°F (5.0°C) or less	24 hours
>41°F - 45°F (>5.0°C - 7.2°C)	20 hours
>45°F - 50°F (>7.2°C - 10.0°C)	16 hours
>50°F - 55°F (>10.0°C - 12.8°C)	10 hours

b. The cleaning frequency based on the ambient temperature of the refrigerated room or area is documented in the food establishment.

3. Containers in serving situations such as salad bars, delis, and cafeteria lines hold ready-to-eat potentially hazardous time/temperature control for safety food that is maintained at the temperatures specified under Part III, are intermittently combined with additional supplies of the same food that is at the required temperature, and the containers are cleaned at least every 24 hours;

4. Temperature measuring devices are maintained in contact with food, such as when left in a container of deli food or in a roast, held at temperatures specified under Part III;

5. Equipment is used for storage of packaged or unpackaged food such as a reach-in refrigerator and the equipment is cleaned at a frequency necessary to preclude accumulation of soil residues; or

6. The cleaning schedule is approved based on consideration of:

a. Characteristics of the equipment and its use;

b. The type of food involved;

c. The amount of food residue accumulation; and

d. The temperature at which the food is maintained during the operation and the potential for the rapid and progressive multiplication of pathogenic or toxigenic microorganisms that are capable of causing foodborne disease; or

7. In-use utensils are intermittently stored in a container of water in which the water is maintained at 135°F (57°C) or more and the utensils and container are cleaned at least every 24 hours or at a frequency necessary to preclude accumulation of soil residues.

E. Except when dry cleaning methods are used as specified under 2VAC5-585-1810, surfaces of utensils and equipment contacting food that is not potentially hazardous time/temperature control for safety food shall be cleaned:^N

1. At any time when contamination may have occurred;

2. At least every 24 hours for iced tea dispensers and consumer self-service utensils such as tongs, scoops, or ladles;

3. Before restocking consumer self-service equipment and utensils such as condiment dispensers and display containers; and

4. Equipment In equipment such as ice bins and beverage dispensing nozzles and enclosed components of equipment such as ice makers, cooking oil storage tanks and distribution lines, beverage and syrup dispensing lines or tubes, coffee bean grinders, and water vending equipment:

a. At a frequency specified by the manufacturer; or

b. Absent manufacturer specifications, at a frequency necessary to preclude accumulation of soil or mold.

2VAC5-585-1790. Cooking and baking equipment.

A. The food-contact surfaces of in-use cooking and baking equipment shall be cleaned at least every 24 hours. This section does not apply to hot oil cooking and filtering equipment if it is cleaned as specified in 2VAC5-585-1780 D 6.

B. The cavities and door seals of microwave ovens shall be cleaned at least every 24 hours by using the manufacturer's recommended cleaning procedure.

2VAC5-585-1810. Dry cleaning.

A. If used, dry cleaning methods such as brushing, scraping, and vacuuming shall contact only surfaces that are soiled with dry food residues that are not potentially hazardous time/temperature control for safety food.

B. Cleaning equipment used in dry cleaning food-contact surfaces may not be used for any other purpose.

2VAC5-585-1870. Returnables, cleaning for refilling.* (Repealed.)

A. Except as specified in subsections B and C of this section, returned empty containers intended for cleaning and refilling with food shall be cleaned and refilled in a regulated food processing plant.

B. A food-specific container for beverages may be refilled at a food establishment if:

1. Only a beverage that is not a potentially hazardous food is used as specified under 2VAC5-585-600 A;

2. The design of the container and of the rinsing equipment and the nature of the beverage, when considered together, allow effective cleaning at home or in the food establishment;

3. Facilities for rinsing before refilling returned containers with fresh, hot water that is under pressure and not recirculated are provided as part of the dispensing system;

4. The consumer-owned container returned to the food establishment for refilling is refilled for sale or service only to the same consumer; and

5. The container is refilled by:

a. An employee of the food establishment; or

b. The owner of the container if the beverage system includes a contamination-free transfer process that cannot be bypassed by the container owner.

C. Consumer-owned containers that are not food-specific may be filled at a water vending machine or system.

Article 7
Sanitization of Equipment and Utensils

2VAC5-585-1885. Food-contact surfaces and utensils.

Equipment food-contact surfaces and utensils shall be sanitized.

2VAC5-585-1890. Before use after cleaning.*

Utensils and food-contact surfaces of equipment shall be sanitized before use after cleaning.^P

2VAC5-585-1900. Hot water and chemical.*

After being cleaned, equipment food-contact surfaces and utensils shall be sanitized in:

1. Hot water manual operations by immersion for at least 30 seconds as specified under 2VAC5-585-1670;^P

2. Hot water mechanical operations by being cycled through equipment that is set up as specified under 2VAC5-585-1610, 2VAC5-585-1680, and 2VAC5-585-1690 and achieving a utensil surface temperature of 160°F (71°C) as measured by an irreversible registering temperature indicator;^P or

3. Chemical manual or mechanical operations, including the application of sanitizing chemicals by immersion, manual swabbing, brushing, or pressure spraying methods, using a solution as specified under 2VAC5-585-1700. Contact times shall be consistent with those on EPA-registered label use instructions by providing:

a. Except as specified under subdivision 3 b of this section, an exposure a contact time of at least 10 seconds for a chlorine solution specified under subdivision 1 of 2VAC5-585-1700;^P

b. An exposure A contact time of at least 7 seven seconds for a chlorine solution of 50 mg/L that has a pH of 10 or less and a temperature of at least 100°F (38°C) or a pH of 8 8.0 or less and a temperature of at least 75°F (24°C);^P

c. An exposure A contact time of at least 30 seconds for other chemical sanitizing solutions;^P or

d. An exposure A contact time used in relationship with a combination of temperature, concentration, and pH that, when evaluated for efficacy, yields sanitization as defined in 2VAC5-585-40.^P

2VAC5-585-1920. Specifications.

A. Linens that do not come in direct contact with food shall be laundered between operations if they become wet, sticky, or visibly soiled.

B. Cloth gloves used as specified in 2VAC5-585-580 D shall be laundered before being used with a different type of raw animal food such as beef, lamb, pork, and fish, or poultry.

C. Linens and napkins that are used as specified under 2VAC5-585-560 and cloth napkins shall be laundered between each use.

D. Wet wiping cloths shall be laundered daily.

E. Dry wiping cloths shall be laundered as necessary to prevent contamination of food and clean serving utensils.

Article 9
Protection of Clean Items

2VAC5-585-1960. Equipment and utensils, air-drying required.

After cleaning and sanitizing, equipment and utensils:

1. Shall be air dried or used after adequate draining as specified in 40 CFR 180.9401 the first paragraph of 40 CFR 180.940 before contact with food; and

2. May not be cloth dried except that utensils that have been air-dried may be polished with cloths that are maintained clean and dry.

2VAC5-585-2000. Equipment, utensils, linens, and single-service and single-use articles.

A. Except as specified in subsection D of this section, cleaned equipment and utensils, laundered linens, and single-service and single-use articles shall be stored:

1. In a clean, dry location;

2. Where they are not exposed to splash, dust, or other contamination; and

3. At least six inches (15 cm) centimeters) above the floor.

B. Clean equipment and utensils shall be stored as specified under subsection A of this section and shall be stored:

1. In a self-draining position that allows air drying; and

2. Covered or inverted.

C. Single-service and single-use articles shall be stored as specified under subsection A of this section and shall be kept in the original protective package or stored by using other means that afford protection from contamination until used.

D. Items that are kept in closed packages may be stored less than six inches (15 cm) centimeters) above the floor on dollies, pallets, racks, and skids that are designed as provided under 2VAC5-585-1420.

2VAC5-585-2010. Prohibitions.

A. Except as specified in subsection B of this section, cleaned and sanitized equipment, utensils, laundered linens, and single-service and single-use articles may not be stored:

1. In locker rooms;

2. In toilet rooms or vestibules;

3. In garbage rooms;

4. In mechanical rooms;

5. Under sewer lines that are not shielded to intercept potential drips;

6. Under leaking water lines including leaking automatic fire sprinkler heads or under lines on which water has condensed;

7. Under open stairwells; or

8. Under other sources of contamination.

B. Laundered linens and single-service and single-use articles that are packaged or in a facility such as a cabinet may be stored in a locker room.

2VAC5-585-2040. Preset tableware.

A. Tableware Except as specified in subsection B of this section, tableware that is preset shall be protected from contamination by being wrapped, covered, or inverted.

B. When tableware is preset, exposed, unused settings shall be:

1. Removed when a consumer is seated; or

2. Cleaned and sanitized before further use if the settings are not removed when a consumer is seated.

B. Preset tableware may be exposed if:

1. Unused settings are removed when a consumer is seated; or

2. Settings not removed when a consumer is seated are cleaned and sanitized before further use.

2VAC5-585-2045. Rinsing equipment and utensils after cleaning.

After being cleaned and sanitized, equipment and utensils shall not be rinsed before air drying or use unless:

1. The rinse is applied directly from a potable water supply by a warewashing machine that is maintained and operated as specified under 2VAC5-585-1210 through 2VAC5-585-1430 and 2VAC5-585-1570 through 2VAC5-585-1720; and

2. The rinse is applied only after the equipment and utensils have been sanitized by the application of hot water or by the application of a chemical sanitizer solution whose EPA-registered label use instructions call for rinsing off the sanitizer after it is applied in a commercial warewashing machine.

Part V
Water, Plumbing, and Waste

Article 1
Water

2VAC5-585-2050. Approved system.*

[ Drinking Pure ] water shall be obtained from an approved [ source that is water system defined as ]:

1. A [ public water system waterworks constructed, maintained, and operated in compliance with 12VAC5-590 ];^P or

2. A [ nonpublic water system that is constructed, maintained, and operated according to law private well constructed, maintained, and operated in compliance with 12VAC5-630 ].^P

2VAC5-585-2060. System flushing and disinfection.*

[ A drinking water An approved water ] system shall be flushed and disinfected [ before being placed in service ] after construction, repair, or modification and after an emergency situation, such as a flood, that may introduce contaminants to the system. [ A sample shall be collected from the water system and the results of the analysis shall be total coliform negative prior to placing the water system into service. ]^P

2VAC5-585-2070. Bottled drinking water.*

Bottled drinking water used or sold in a food establishment shall be obtained from approved sources in accordance with 21 CFR Part 129, Processing and Bottling of Bottled Drinking Water.^P

2VAC5-585-2080. [ Quality Pure water ] standards.*

Except as specified under 2VAC5-585-2090:

1. Water from a [ public water system waterworks ] shall meet [ the applicable water quality and quantity ] standards [ found in 40 CFR Part 141 and the Virginia Waterworks Regulations (12VAC5-590) in accordance with 12VAC5-590 ].^P

2. Water from a [ nonpublic water system private well ] shall meet state drinking water quality standards [ the bacteriological standards found in the Virginia Waterworks Regulations (12VAC5-590) water quality and quantity standards in accordance with 12VAC5-630-370 ].^P

2VAC5-585-2090. [ Nondrinking Nonpotable ] water.*

A. A [ nondrinking nonpotable ] water supply shall be used only if its use is approved.^P

B. [ Nondrinking Nonpotable ] water shall be used only for nonculinary purposes such as air conditioning, nonfood equipment cooling, and fire protection, and irrigation.^P

2VAC5-585-2100. Sampling.

[ Except when used as specified under 2VAC5-585-2090, water A. Water ] from a [ nonpublic water system private well ] shall be sampled and tested at least annually [ and as required by state water quality regulations for nitrate and total coliform ]. [ ^Pf ]

[ B. If nitrate, which is reported as "N" on the test results, exceeds 10 mg/L, the operator shall notify the department by the end of the day the operator is notified of the test result. Additional sampling may be required.^Pf

C. If a sample is total coliform positive, the positive culture medium shall be further analyzed to determine if E. coli is present.  The operator shall notify the department within two days from when the operator is notified of the coliform-positive test result. ^Pf

D. If E. coli is present, the operator shall notify the department by the end of the day the operator is notified of the test result.^Pf ]

[ 2VAC5-585-2110. Sample report.

The most recent All sample report reports for the nonpublic water system private well shall be retained on file in the food establishment or the report shall be maintained as specified by state water quality regulations for a minimum of five years and be made available to the department upon request. ]

2VAC5-585-2120. Capacity.*

A. The water source and system shall be of sufficient capacity to meet the [ peak maximum daily ] water demands [ and the peak hourly water demands ] of the food establishment.^Pf

B. Hot water generation and distribution systems shall be sufficient to meet the peak hot water demands throughout the food establishment.^Pf

2VAC5-585-2130. Pressure.

Water under pressure shall be provided to all fixtures, equipment, and nonfood equipment that are required to use water except that water supplied as specified under subdivisions 1 and 2 of 2VAC5-585-2160 to a temporary food establishment or in response to a temporary interruption of a water supply need not be under pressure.^Pf

2VAC5-585-2150. Distribution, delivery, and retention system.

Water shall be received from the source through the use of:

1. An approved public water main;^Pf or

2. One or more of the following that shall be constructed, maintained, and operated according to law:^Pf

a. Nonpublic water main, water pumps, pipes, hoses, connections, and other appurtenances;^Pf

b. Water transport vehicles; and^Pf or

c. Water containers.^Pf

2VAC5-585-2160. Alternative water supply.

Water meeting the requirements specified under 2VAC5-585-2050 through 2VAC5-585-2130 shall be made available for a mobile facility, for a temporary food establishment without a permanent water supply, and for a food establishment with a temporary interruption of its water supply through:

1. A supply of containers of commercially bottled drinking water;^Pf

2. One or more closed portable water containers;^Pf

3. An enclosed vehicular water tank;^Pf

4. An on-premises water storage tank;^Pf or

5. Piping, tubing, or hoses connected to an adjacent approved source.^Pf

Article 2
Plumbing System

2VAC5-585-2170. Approved materials.*

A. A plumbing system and hoses conveying water shall be constructed and repaired with approved materials according to law.^P

B. A water filter shall be made of safe materials.^P

2VAC5-585-2180. Approved system and cleanable fixtures.*

A. A plumbing system shall be designed, constructed, and installed according to law.^P

B. A plumbing fixture such as a handwashing lavatory sink, toilet, or urinal shall be easily cleanable.^N

2VAC5-585-2190. Handwashing sink, water temperature, and flow.

A. A handwashing sink shall be equipped to provide water at a temperature of at least 100°F (38°C) through a mixing valve or combination faucet.^Pf

B. A steam mixing valve may not be used at a handwashing sink.

C. A self-closing, slow-closing, or metering faucet shall provide a flow of water for at least 15 seconds without the need to reactivate the faucet.

D. If an automatic handwashing facility is installed, it shall be installed in accordance with manufacturer's instructions.

2VAC5-585-2200. Backflow prevention, air gap.*

An air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch (25 mm).^P

2VAC5-585-2210. Backflow prevention device, design standard.

A backflow or backsiphonage prevention device installed on a water supply system shall comply with the Virginia Uniform Statewide Building Code (13VAC5-63) for construction, installation, maintenance, inspection, and testing for that specific application and type of device.^P

2VAC5-585-2230. Handwashing sinks, numbers and capacities.*

A. Except as specified in subsections B and C of this section, at least one handwashing sink, or the number of handwashing sinks necessary for their convenient use by employees in areas specified under 2VAC5-585-2280, and not fewer than the number of handwashing sinks required by law shall be provided.^Pf

B. If approved and capable of removing the types of soils encountered in the food operations involved, automatic handwashing facilities may be substituted for handwashing sinks in a food establishment that has at least one handwashing sink.

C. If approved, when food exposure is limited and handwashing sinks are not conveniently available, such as in some mobile or temporary food establishments or at some vending machine locations, employees may use chemically-treated towelettes for handwashing.

2VAC5-585-2240. Toilets and urinals.*

At least one toilet and not fewer than the toilets required by law shall be provided. If authorized by law and urinals are substituted for toilets, the substitution shall be done as specified in law.

2VAC5-585-2250. Service sink.

A. At least one service sink or one curbed cleaning facility equipped with a floor drain shall be provided and conveniently located for the cleaning of mops or similar wet floor cleaning tools and for the disposal of mop water and similar liquid waste.

B. Toilets and urinals may not be used as a service sink for the disposal of mop water and similar liquid waste.

2VAC5-585-2260. Backflow prevention device, when required.*

A plumbing system shall be installed to preclude backflow of a solid, liquid, or gas contaminant into the water supply system at each point of use at the food establishment, including on a hose bibb (threaded faucet) if a hose is attached or on a hose bibb if a hose is not attached and backflow prevention is required by law by:

1. Providing an air gap as specified under 2VAC5-585-2200;^P or

2. Installing an approved backflow prevention device as specified under 2VAC5-585-2210.^P

2VAC5-585-2270. Backflow prevention device, carbonator.*

A. If not provided with an air gap as specified under 2VAC5-585-2200, a double check valve with an intermediate vent preceded by a screen of not less than 100 mesh to one inch (100 mesh to 25.4mm) shall be installed upstream from a carbonating device and downstream from any copper in the water supply line.^P

B. A single or double dual check valve attached to the carbonator need not be of the vented type if an air gap or vented backflow prevention device has been otherwise provided as specified under subsection A of this section.

2VAC5-585-2280. Handwashing sinks, locations.*

A handwashing sink shall be located:

1. To be readily accessible for allow convenient use by employees in food preparation, food dispensing, and warewashing areas;^Pf and

2. In, or immediately adjacent to, toilet rooms.^Pf

2VAC5-585-2310. Using a handwashing sink.

A. A handwashing sink shall be maintained so that it is accessible at all times for employee use.^Pf

B. A handwashing sink may not be used for purposes other than handwashing.^Pf

C. An automatic handwashing sink shall be used in accordance with manufacturer's instructions.^Pf

2VAC5-585-2320. Prohibiting a cross connection.*

A. Except as specified in 9 CFR 308.3(d) for firefighting, a A person may not create a cross connection by connecting a pipe or conduit between the drinking water system and a nondrinking water system or a water system of unknown quality.^P

B. The piping of a nondrinking water system shall be durably identified so that it is readily distinguishable from piping that carries drinking water.^{N Pf}

2VAC5-585-2330. Scheduling inspection and service for a water system device.

A device such as a water treatment device or backflow preventer shall be scheduled for inspection and service, in accordance with manufacturer's instructions and as necessary to prevent device failure based on local water conditions, and records demonstrating inspection and service shall be maintained by the person in charge.^Pf

2VAC5-585-2340. Water reservoir of fogging devices, cleaning.*

A. A reservoir that is used to supply water to a device such as a produce fogger shall be:

1. Maintained in accordance with manufacturer's specifications;^P and

2. Cleaned in accordance with manufacturer's specifications or according to the procedures specified under subsection B of this section, whichever is more stringent.^P

B. Cleaning procedures shall include at least the following steps and shall be conducted at least once a week:

1. Draining and complete disassembly of the water and aerosol contact parts;^P

2. Brush-cleaning the reservoir, aerosol tubing, and discharge nozzles with a suitable detergent solution;^P

3. Flushing the complete system with water to remove the detergent solution and particulate accumulation;^P and

4. Rinsing by immersing, spraying, or swabbing the reservoir, aerosol tubing, and discharge nozzles with at least 50 mg/L (ppm) hypochlorite solution.^P

2VAC5-585-2350. System maintained in good repair.*

A plumbing system shall be:

1. Repaired according to law;^P and

2. Maintained in good repair.^S

Article 3
Mobile Water Tank and Mobile Food Establishment Water Tank

2VAC5-585-2360. Approved materials.

Materials that are used in the construction of a mobile water tank, mobile food establishment water tank, and appurtenances shall be:

1. Safe;^P

2. Durable, corrosion resistant, and nonabsorbent; and

3. Finished to have a smooth, easily cleanable surface.

2VAC5-585-2420. Hose, construction and identification.

A hose used for conveying [ drinking potable ] water from a water tank shall be:

1. Safe;^P

2. Durable, corrosion resistant, and nonabsorbent;

3. Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decomposition;

4. Finished with a smooth interior surface; and

5. Clearly and durably identified as to its use if not permanently attached.

2VAC5-585-2430. Filter, compressed air.

A filter that does not pass oil or oil vapors shall be installed in the air supply line between the compressor and [ drinking potable ] water system when compressed air is used to pressurize the water tank system.^P

2VAC5-585-2460. System flushing and disinfection.*

A water tank, pump, and hoses shall be flushed and sanitized before being placed in service after construction, repair, modification, and periods of nonuse.^P

2VAC5-585-2490. Tank, pump, and hoses, dedication.

A. Except as specified in subsection B of this section, a water tank, pump, and hoses used for conveying drinking water shall be used for no other purpose.^P

B. Water tanks, pumps, and hoses approved for liquid foods may be used for conveying drinking water if they are cleaned and sanitized before they are used to convey water.

2VAC5-585-2505. Establishment drainage system.

Food establishment drainage systems, including grease traps, that convey sewage shall be designed and installed as specified under 2VAC5-585-2180 A.

2VAC5-585-2520. Backflow prevention.*

A. Except as specified in subsections B, C, and D of this section, a direct connection may not exist between the sewage system and a drain originating from equipment in which food, portable equipment, or utensils are placed.^P

B. Subsection A of this section does not apply to floor drains that originate in refrigerated spaces that are constructed as an integral part of the building.

C. If allowed by law, a warewashing machine may have a direct connection between its waste outlet and a floor drain when the machine is located within five feet (1.5 meters) of a trapped floor drain and the machine outlet is connected to the inlet side of a properly vented floor drain trap.

D. If allowed by law, a warewashing or culinary sink may have a direct connection.

2VAC5-585-2540. Conveying sewage.*

Sewage shall be conveyed to the point of disposal through an approved sanitary sewage system or other system, including use of sewage transport vehicles, waste retention tanks, pumps, pipes, hoses, and connections that are constructed, maintained, and operated according to law.^P

2VAC5-585-2550. Removing mobile food establishment wastes.

Sewage and other liquid wastes shall be removed from a mobile food establishment at an approved waste servicing area or by a sewage transport vehicle in such a way that a public health hazard or nuisance is not created.^Pf

2VAC5-585-2570. Approved sewage disposal system.*

Sewage shall be disposed through an approved facility that is:

1. A public sewage treatment plant;^P or

2. An individual sewage disposal system that is sized, constructed, maintained, and operated according to law in accordance with the regulations promulgated pursuant to Chapter 6 (§ 32.1-163 et seq.) of Title 32.1 of the Code of Virginia.^P

2VAC5-585-2595. Indoor storage area.

If located within the food establishment, a storage area for refuse, recyclables, and returnables shall meet the requirements specified under 2VAC5-585-2790, 2VAC5-585-2810 through 2VAC5-585-2880, 2VAC5-585-2930, and 2VAC5-585-2940.

2VAC5-585-2840. Floor carpeting, restrictions and installation.

A. A floor covering such as carpeting or similar material may not be installed as a floor covering in food preparation areas, walk-in refrigerators, warewashing areas, toilet room areas where handwashing lavatories sinks, toilets, and urinals are located, refuse storage rooms, or other areas where the floor is subject to moisture, flushing, or spray cleaning methods.

B. If carpeting is installed as a floor covering in areas other than those specified under subsection A of this section, it shall be:

1. Securely attached to the floor with a durable mastic, by using a stretch and tack method, or by another method; and

2. Installed tightly against the wall under the coving or installed away from the wall with a space between the carpet and the wall and with the edges of the carpet secured by metal stripping or some other means.

2VAC5-585-2930. Outer openings, protected.

A. Except as specified in subsections B through E of this section, outer openings of a food establishment shall be protected against the entry of insects and rodents by:

1. Filling or closing holes and other gaps along floors, walls and ceilings;

2. Closed, tight-fitting windows; and

3. Solid self-closing, tight-fitting doors.

B. Subsection A of this section does not apply if a food establishment opens into a larger structure, such as a mall, airport, or office building, or into an attached structure, such as a porch, and the outer openings from the larger or attached structure are protected against the entry of insects and rodents.

C. Exterior doors used as exits need not be self-closing if they are:

1. Solid and tight-fitting;

2. Designated for use only when an emergency exists, by the fire protection authority that has jurisdiction over the food establishment; and

3. Restricted Limited-use so they are not used for entrance or exit from the building for purposes other than the designated emergency exit use.

D. Except as specified in subsections B and E of this section, if the windows or doors of a food establishment, or of a larger structure within which a food establishment is located, are kept open for ventilation or other purposes, or a temporary food establishment is not provided with windows and doors as specified in subsection A of this section, the openings shall be protected against the entry of insects and rodents by:

1. 16 mesh to one-inch (16 mesh to 25.4-mm) screens;

2. Properly designed and installed air curtains to control flying insects; or

3. Other effective means.

E. Subsection D of this section does not apply if flying insects and other pests are absent due to the location of the establishment, the weather, or other limiting condition.

2VAC5-585-2990. Private homes and living or sleeping quarters, use prohibition.

A private home, a room used as living or sleeping quarters, or an area directly opening into a room used as living or sleeping quarters may not be used for conducting food establishment operations.^P

2VAC5-585-3000. Living or sleeping quarters, separation.

Sleeping Living or sleeping quarters located on the premises of a food establishment such as those provided for lodging registration clerks or resident managers shall be separated from rooms and areas used for food establishment operations by complete partitioning and solid self-closing doors.

2VAC5-585-3020. Handwashing cleanser, availability.

Each handwashing sink or group of two adjacent handwashing sinks shall be provided with a supply of hand cleaning liquid, powder, or bar soap.^Pf

2VAC5-585-3030. Hand drying provision.

Each handwashing sink or group of adjacent handwashing sinks shall be provided with:

1. Individual, disposable towels;^Pf

2. A continuous towel system that supplies the user with a clean towel; or ^Pf

3. A heated-air hand drying device;^Pf or

4. A hand-drying device that employs an air-knife system that delivers high velocity, pressurized air at ambient temperatures.^Pf

2VAC5-585-3040. Handwashing aids and devices, use restrictions.

A sink used for food preparation or utensil washing or a service sink or curbed cleaning facility used for the disposal of mop water or similar wastes may not be provided with the handwashing aids and devices required for a handwashing sink as specified under 2VAC5-585-2650 C, 2VAC5-585-3020, and 2VAC5-585-3030 and 2VAC5-585-2650 C.

2VAC5-585-3047. Disposable towels, waste receptacle.

A handwashing sink or group of adjacent handwashing sinks that is provided with disposable towels shall be provided with a waste receptacle as specified under 2VAC5-585-2650 C.

2VAC5-585-3070. Toilet tissue, availability.

A supply of toilet tissue shall be available at each toilet.^Pf

2VAC5-585-3130. Toilet rooms, convenience and accessibility.

Toilet rooms shall be conveniently located and accessible to employees during all hours of operation. Toilet rooms intended for use by customers shall not necessitate travel through food preparation or handling areas.

2VAC5-585-3150. Distressed merchandise, segregation and location.

Products that are held by the person in charge operator for credit, redemption, or return to the distributor, such as damaged, spoiled, or recalled products, shall be segregated and held in designated areas that are separated from food, equipment, utensils, linens, and single-service and single-use articles.^Pf

2VAC5-585-3210. Cleaning maintenance tools, preventing contamination.*

Food preparation sinks, handwashing lavatories sinks, and warewashing equipment may not be used for the cleaning of maintenance tools, the preparation or holding of maintenance materials, or the disposal of mop water and similar liquid wastes.^Pf

2VAC5-585-3240. Cleaning of plumbing fixtures.

Plumbing fixtures such as handwashing sinks, toilets, and urinals shall be cleaned as often as necessary to keep them clean and maintained and used as specified under 2VAC5-585-2310.

2VAC5-585-3250. Closing toilet room doors.

Toilet room doors as specified under 2VAC5-585-2920 shall be kept closed except during cleaning and maintenance operations unless otherwise required by other regulations or law. Except during cleaning and maintenance operations, toilet room doors as specified under 2VAC5-585-2920 shall be kept closed.

2VAC5-585-3270. Controlling pests.*

The presence premises shall be maintained free of insects, rodents, and other pests. The presence of insects, rodents, and other pests shall be controlled to minimize eliminate their presence on the premises by:

1. Routinely inspecting incoming shipments of food and supplies;^N

2. Routinely inspecting the premises for evidence of pests;^N

3. Using methods, if pests are found, such as trapping devices or other means of pest control as specified under 2VAC5-585-3360, 2VAC5-585-3440, and 2VAC5-585-3450;^Pf and

4. Eliminating harborage conditions.^N

2VAC5-585-3310. Prohibiting animals.*

A. Except as specified in subsections B and C of this section, live animals may not be allowed on the premises of a food establishment.^Pf

B. Live animals may be allowed in the following situations if the contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result:

1. Edible fish or decorative fish in aquariums, shellfish or crustacea on ice or under refrigeration, and shellfish and crustacea in display tank systems;

2. Patrol dogs accompanying police or security officers in offices and dining, sales, and storage areas, and sentry dogs running loose in outside fenced areas;

3. In areas that are not used for food preparation and that are usually open for customers, such as dining and sales areas, service animals that are controlled by the disabled employee or person, if a health or safety hazard will not result from the presence or activities of the service animal;

4. Pets in the common dining areas of institutional care facilities such as nursing homes, assisted living facilities, group homes, or residential care facilities at times other than during meals if:

a. Effective partitioning and self-closing doors separate the common dining areas from food storage or food preparation areas;

b. Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining areas when pets are present; and

c. Dining areas including tables, countertops, and similar surfaces are effectively cleaned before the next meal service; [ and ]

5. In areas that are not used for food preparation, storage, sales, display, or dining, in which there are caged animals or animals that are similarly restricted confined, such as in a variety store that sells pets or a tourist park that displays animals [ ; and

6. Dogs in outdoor dining areas if:

a. The outdoor dining area is not fully enclosed with floor to ceiling walls and is not considered a part of the interior physical facility.

b. The outdoor dining area is equipped with an entrance that is separate from the main entrance to the food establishment, and the separate entrance serves as the sole means of entry for patrons accompanied by dogs.

c. A sign stating that dogs are allowed in the outdoor dining area is posted at each entrance to the outdoor dining area in such a manner as to be clearly observable by the public.

d. A sign within the outdoor dining area stating the requirements as specified in subdivisions 6 e, f, and g of this subsection is provided in such a manner as to be clearly observable by the public.

e. Food and water provided to dogs is served using equipment that is not used for the service of food to a person or is served in single-use articles.

f. Dogs are not allowed on chairs, seats, benches, or tables.

g. Dogs are kept on a leash or within a pet carrier and under the control of an adult at all times.

h. The establishment provides effective means for cleaning up dog vomitus and fecal matter ].

C. Live or dead fish bait may be stored if contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result.

Part VII
Poisonous or Toxic Materials

Article 1
Labeling and Identification

2VAC5-585-3320. Original containers - identifying information, prominence.*

Containers of poisonous or toxic materials and personal care items shall bear a legible manufacturer's label.^Pf

2VAC5-585-3330. Working containers - common name.*

Working containers used for storing poisonous or toxic materials such as cleaners and sanitizers taken from bulk supplies shall be clearly and individually identified with the common name of the material.^Pf

Article 2
Operational Supplies and Applications

2VAC5-585-3340. Storage, separation.*

Poisonous or toxic materials shall be stored so they cannot contaminate food, equipment, utensils, linens, and single-service and single-use articles by:

1. Separating the poisonous or toxic materials by spacing or partitioning;^{S P} and

2. Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens, and single-service or single-use articles. This subsection does not apply to equipment and utensil cleaners and sanitizers that are stored in warewashing areas for availability and convenience if the materials are stored to prevent contamination of food, equipment, utensils, linens, and single-service and single-use articles; and.^P

3. Detergents, sanitizers, related cleaning or drying agents and caustics, acids, polishes and other chemicals shall be stored separately from insecticides and rodenticides.

2VAC5-585-3350. Presence and use restriction.*

A. Only those poisonous or toxic materials that are required for the operation and maintenance of a food establishment, such as for the cleaning and sanitizing of equipment and utensils and the control of insects and rodents, shall be allowed in a food establishment.^{S Pf}

B. Subsection A of this section does not apply to packaged poisonous or toxic materials that are for retail sale.

2VAC5-585-3360. Conditions of use.*

A. Poisonous or toxic materials shall be:

1. Used according to:

a. Law and this chapter;

b. Manufacturer's use directions included in labeling, and, for a pesticide, manufacturer's label instructions that state that use is allowed in a food establishment;^P

c. The conditions of certification, if certification is required, for use of the pest control materials;^P and

d. Additional conditions that may be established by the department; and

2. Applied so that:

a. A hazard to employees or other persons is not constituted;^P and

b. Contamination including toxic residues due to drip, drain, fog, splash or spray on food, equipment, utensils, linens, and single-service and single-use articles is prevented, and for a restricted-use pesticide, this is achieved by:^P

(1) Removing the items;^P

(2) Covering the items with impermeable covers;^P or

(3) Taking other appropriate preventive actions;^P and

(4) Cleaning and sanitizing equipment and utensils after the application.^P

B. A restricted use pesticide shall be applied only by an applicator certified as defined in 7 USC § 136(e); §§ 3.2-3929, 3.2-3930, and 3.2-3931 of the Code of Virginia (Virginia Pesticide Control Act); or a person under the direct supervision of a certified applicator.^Pf

2VAC5-585-3370. Poisonous or toxic material containers.*

A container previously used to store poisonous or toxic materials may not be used to store, transport, or dispense food.^P

2VAC5-585-3380. Sanitizers, criteria.*

Chemical sanitizers, including chemical sanitizing solutions generated on site, and other chemical antimicrobials applied to food-contact surfaces shall meet the requirements specified in 40 CRF 180.940.:

1. Meet the requirements specified in 40 CFR 180.940;^P or

2. Meet the requirements as specified in 40 CFR 180.2020.^P

2VAC5-585-3390. Chemicals for washing fruits and vegetables, criteria.*

A. Chemicals, including those generated on site, used to wash or peel raw, whole fruits and vegetables shall meet the requirements specified in 21 CFR 173.315 40 CFR Part 156 and shall:^P

1. Be an approved food additive listed for this intended use in 21 CFR Part 173;^P

2. Be generally recognized as safe for this intended use;^P or

3. Be the subject of an effective food contact notification for this intended use (only effective for the manufacturer or supplier identified in the notification).^P

B. Ozone as an antimicrobial agent used in the treatment, storage, and processing of fruits and vegetables in a food establishment shall meet the requirements specified in 21 CFR 173.368.^P

2VAC5-585-3400. Boiler water additives, criteria.*

Chemicals used as boiler water additives shall meet the requirements specified in 21 CFR 173.310.^P

2VAC5-585-3410. Drying agents, criteria.*

Drying agents used in conjunction with sanitization shall:

1. Contain only components that are listed as one of the following:

a. Generally recognized as safe for use in food as specified in 21 CFR Part 182, Substances Generally Recognized as Safe, or 21 CFR Part 184, Direct Food Substances Affirmed as Generally Recognized as Safe;^P

b. Generally recognized as safe for the intended use as specified in 21 CFR Part 186, Indirect Food Substances Affirmed as Generally Recognized as Safe;^P

c. Generally recognized as safe for the intended use as determined by experts qualified in scientific training and experience to evaluate the safety  of substances added, directly or indirectly, to food as described in 21 CFR 170.30;^P

d. Subject of an effective food contact notification as described in § 409(h) of the Federal Food, Drug, and Cosmetic Act (21 USC § 348(h));^P

e. Approved for use as a drying agent under a prior sanction specified in 21 CFR Part 181, Prior-Sanctioned Food Ingredients as described in § 201(s)(4) of the Federal Food, Drug, and Cosmetic Act (21 USC § 321(s)(4));^P

d. f. Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 CFR Parts 175-178 174-178;^P or

e. g. Approved for use as a drying agent under the threshold of regulation process established by 21 CFR 170.39, Threshold of Regulation for Substances Used in Food-Contact Articles;^P and

2. When sanitization is with chemicals, the approval required under subdivisions 1 c or subdivision 1 e or 1 g of this section or the regulation chapter as an indirect food additive required under subdivision 1 d f of this section, shall be specifically for use with chemical sanitizing solutions.^P

2VAC5-585-3420. Lubricants - incidental food contact, criteria.*

Lubricants shall meet the requirements specified in 21 CFR 178.3570 if they are used on food-contact surfaces, on bearings and gears located on or within food-contact surfaces, or on bearings and gears that are located so that lubricants may leak, drip, or be forced into food or onto food-contact surfaces.^P

2VAC5-585-3430. Restricted use pesticides, criteria.*

Restricted use pesticides specified under subsection B of 2VAC5-585-3360 shall meet the requirements specified in 40 CFR Part 152, Subpart I, Classification of Pesticides.^P

2VAC5-585-3440. Rodent bait stations.*

Rodent bait shall be contained in a covered, tamper-resistant bait station.^P

2VAC5-585-3450. Tracking powders, pest control and monitoring.*

A. A Except as specified in subsection B of this section, a tracking powder pesticide may not be used in a food establishment.^P

B. If used, a nontoxic tracking powder such as talcum or flour may not contaminate food, equipment, utensils, linens, and single-service and single-use articles.^N

2VAC5-585-3460. Medicines - restriction and storage.*

A. Except for medicines that are stored or displayed for retail sale, only those medicines that are necessary for the health of employees shall be allowed in a food establishment.^Pf

B. Medicines that are in a food establishment for the employees' use shall be labeled as specified under 2VAC5-585-3320 and located to prevent the contamination of food, equipment, utensils, linens, and single-service and single-use articles.^P

2VAC5-585-3470. Refrigerated medicines, storage.*

Medicines belonging to employees or to children in a day care center that require refrigeration and are stored in a food refrigerator shall be:

1. Stored in a package or container and kept inside a covered, leakproof container that is identified as a container for the storage of medicines;^P and

2. Located so they are inaccessible to children.^P

2VAC5-585-3480. First aid supplies, storage.*

First aid supplies that are in a food establishment for the employees' use shall be:

1. Labeled as specified under 2VAC5-585-3320;^{S Pf} and

2. Stored in a kit or a container that is located to prevent the contamination of food, equipment, utensils, and linens, and single-service and single-use articles.^{S P}

Article 3
Stock and Retail Sale

2VAC5-585-3500. Storage and display, separation.*

Poisonous or toxic materials shall be stored and displayed for retail sale so they cannot contaminate food, equipment, utensils, linens, and single-service and single-use articles by:

1. Separating the poisonous or toxic materials by spacing or partitioning;^{S P} and

2. Locating the poisonous or toxic materials in an area that is not above food, equipment, utensils, linens, and single-service or single-use articles.^P

Part VIII
Compliance and Enforcement

Article 1
Applicability of Chapter

2VAC5-585-3510. Public health protection.

A. The department shall apply this regulation chapter to promote its underlying purpose, as specified in 2VAC5-585-20, of safeguarding public health and ensuring that food is safe and, unadulterated, and honestly presented when offered to the consumer.

B. In enforcing the provisions of this regulation chapter, the department shall assess existing facilities or equipment that were in use before the effective date of this regulation chapter based on the following considerations:

1. Whether the facilities or equipment are in good repair and capable of being maintained in a sanitary condition;

2. Whether food-contact surfaces comply with 2VAC5-585-960 through 2VAC5-585-1060;

3. Whether the capacities of cooling, heating, and holding equipment are sufficient to comply with 2VAC5-585-1450; and

4. The existence of a documented agreement with the establishment operator that the facilities or equipment will be replaced or upgraded as specified in the following: subdivision 6 of 2VAC5-585-3660.

a. Except as specified under subdivision B 4 b of this section, replace existing facilities and equipment specified in this section with facilities and equipment that comply with this regulation if:

(1) The department directs the replacement because the facilities and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the facilities and equipment were accepted;

(2) The department directs the replacement of the facilities and equipment because of a change of ownership; or

(3) The facilities and equipment are replaced in the normal course of operation;

b. Upgrade or replace refrigeration equipment as specified under 2VAC5-585-820 A 2 b, if the circumstances specified under subdivision B 4 a of this section do not occur first.

2VAC5-585-3541. Documentation of proposed variance and justification.

Before a variance from a requirement of this regulation chapter is approved, the information that shall be provided by the person requesting the variance and retained in the department's file on the food establishment includes:

1. A statement of the proposed variance of the regulation requirement citing relevant regulation section numbers;^Pf

2. An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant regulation sections will be alternatively addressed by the proposal;^Pf and

3. A HACCP plan if required as specified under 2VAC5-585-3620 A that includes the information specified under 2VAC5-585-3630 as it is relevant to the variance requested.^Pf

2VAC5-585-3542. Conformance with approved procedures.*

If the department grants a variance as specified in 2VAC5-585-3540, or a HACCP plan is otherwise required as specified under 2VAC5-585-3620, the operator shall:

1. Comply with the HACCP plans and procedures that are submitted as specified under 2VAC5-585-3630 and approved as a basis for the modification or waiver;^P and

2. Maintain and provide to the department, upon request, records specified under subdivisions 4 and 5 [ c ] of 2VAC5-585-3630 that demonstrate that the following are routinely employed:

a. Procedures for monitoring critical control points;^Pf

b. Monitoring of the critical control points;^Pf

c. Verification of the effectiveness of an operation or process;^Pf and

d. Necessary corrective actions if there is failure at a critical control point.^Pf

Article 2
Plan Submission and Approval

2VAC5-585-3600. Facility and operating plans - when plans are required.

An operator shall submit to the department properly prepared plans and specifications for review and approval when appropriate or when requested by the department. Such instances shall include before:

1. The construction of a food establishment;^Pf

2. The conversion of an existing structure for use as a food establishment;^Pf or

3. The remodeling of a food establishment or a change of type of food establishment or food operation if the department determines that plans and specifications are necessary to ensure compliance with this regulation chapter.^Pf

2VAC5-585-3620. When a HACCP plan is required.

A. Before engaging in an activity that requires a HACCP plan, an operator shall submit to the department for approval a properly prepared HACCP plan as specified under 2VAC5-585-3630 and the relevant provisions of this chapter if:

1. Submission of a HACCP plan is required according to law;

2. A variance is required as specified under 2VAC5-585-700 D 4, 2VAC5-585-860, or 2VAC5-585-1300 B, or subdivision 2VAC5-585-700 D 3; or

3. The department determines that a food preparation or processing method requires a variance based on a plan submittal specified under 2VAC5-585-3610, an inspectional finding, or a variance request.

B. An operator shall have a properly prepared HACCP plan Before engaging in reduced oxygen packaging without a variance as specified under 2VAC5-585-870, an operator shall submit a properly prepared HACCP plan to the department.

2VAC5-585-3630. Contents of a HACCP plan.

For a food establishment that is required under 2VAC5-585-3620 to have a HACCP plan, the [ plan and specifications shall indicate operator shall submit to the department a properly prepared HACCP plan that includes ]:

1. [ General information such as the name of the operator, the food establishment address, and contact information;

2. ] A categorization of the types of potentially hazardous time/temperature control for safety foods that are [ specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the department to be controlled under the HACCP plan ];^Pf

[ 2. 3. ] A flow diagram [ by specific food or category type identifying critical control points and providing information on the following or chart for each specific food or category type that identifies ]:

a. [ Ingredients, materials, and equipment used in the preparation of that food Each step in the process ];^Pf [ and ]

b. [ Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved The hazards and controls for each step in the flow diagram or chart ];^Pf

[ c. The steps that are critical control points;^Pf

d. The ingredients, materials, and equipment used in the preparation of that food;^Pf and

e. The formulations or recipe that delineates methods and procedural control measures that address the food safety concerns involved;^Pf ]

[ 3. Food employee and supervisory training plan that addresses the food safety issues of concern;^Pf ]

4. [ A statement of standard operating procedures for the plan under consideration including clearly identifying A critical control points summary for each specific food category type that clearly identifies ]:

a. Each critical control point;^Pf

b. The critical limits for each critical control point;^Pf

c. The method and frequency for monitoring and controlling each critical control point by the [ designated ] food employee [ designated by or ] the person in charge;^Pf

d. The method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;^Pf

e. Action to be taken by the [ designated food employee or ] person in charge if the critical limits for each critical control point are not met;^Pf and

f. Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed;^Pf [ and ]

5. [ Additional scientific data or other information, as required by the department, supporting the determination that food safety is not compromised by the proposal.^Pf Supporting documents such as:

a. Food employee and supervisory training plan that addresses the food safety issues of concern;^Pf

b. Copies of blank record forms that are necessary to implement the HACCP plan;^Pf

c. Additional scientific data or other information, as required by the department, supporting the determination that food safety is not compromised by the proposal;^Pfand

6. Any other information required by the department. ]

2VAC5-585-3655. Responsibilities of the department.

A. At the time of the initial inspection, the department shall provide to the operator a copy of this chapter so that the operator is notified of the compliance requirements and the conditions of retention, as specified under 2VAC5-585-3660, that are applicable to the food establishment.

B. Failure to provide the information specified in subsection A of this section does not prevent the department from taking authorized action or seeking remedies if the operator fails to comply with this chapter or an order, warning, or directive of the department.

2VAC5-585-3660. Responsibilities of the operator.

The operator shall:

1. Comply with the provisions of this chapter including the conditions of a granted variance as specified under 2VAC5-585-3542 and approved plans as specified under 2VAC5-585-3610;

2. If a food establishment is required under 2VAC5-585-3620 to operate under a HACCP plan, comply with the plan as specified under 2VAC5-585-3542;

3. Immediately contact the department to report an illness of a food employee or conditional employee as specified under 2VAC5-585-80 B;

4. Immediately discontinue operations and notify the department if an imminent health hazard may exist as specified under 2VAC5-585-3910;

5. Allow authorized representatives of the commissioner access to the food establishment as specified under 2VAC5-585-3820;

6. Replace existing facilities and equipment specified in 2VAC5-585-3510 with facilities and equipment that comply with this chapter if:

a. The department directs the replacement because the facilities and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the facilities and equipment were accepted;

b. The department directs the replacement of the facilities and equipment because of a change of ownership; or

c. The facilities and equipment are replaced in the normal course of operation;

7. Comply with directives of the department including timeframes for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the department in regard to the operator's food establishment or in response to community emergencies;

8. Accept notices issued and served by the department according to law;

9. Be subject to the administrative, civil, injunctive, and criminal remedies authorized in law for failure to comply with this chapter or a directive of the department, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives; and

10. Notify customers that a copy of the most recent establishment inspection report is available upon request by posting a sign or placard in a location in the food establishment that is conspicuous to customers or by another method acceptable to the department.

Article 4
Inspection and Correction of Violations

2VAC5-585-3800. Frequency, establishing inspection interval.

Food establishments shall be inspected by the designee of the commissioner. Inspections of food establishments shall be performed as often as necessary for the enforcement of this part in accordance with the following:

1. A. Except as specified in subdivisions 2 and 3 subsections B and C of this section, the department shall inspect a food establishment at least once every six months.

2. B. The department may increase the interval between inspections beyond six months if:

a. 1. The food establishment is fully operating under an approved and validated HACCP plan as specified under 2VAC5-585-3630 and subdivisions 1 and 2 of 2VAC5-585-3542 and 2VAC5-585-3630.

b. 2. The food establishment is assigned a less frequent inspection frequency based on a written risk-based inspection schedule that is being uniformly applied throughout the jurisdiction.

c. 3. The establishment's operation involves only coffee service and other unpackaged or prepackaged food that is not potentially hazardous time/temperature control for safety food such as carbonated beverages and snack food such as chips, nuts, popcorn, and pretzels.

3. C. The department shall periodically inspect a temporary food establishment that prepares, sells, or serves unpackaged potentially hazardous time/temperature control for safety food and that:

a. 1. Has improvised rather than permanent facilities or equipment for accomplishing functions such as handwashing, food preparation and protection, food temperature control, warewashing, providing drinking water, waste retention and disposal, and insect and rodent control; or

b. 2. Has inexperienced food employees.

2VAC5-585-3810. Performance-based and risk-based inspections.

Within the parameters specified in 2VAC5-585-3800, the department shall prioritize, and conduct more frequent inspections based upon its assessment of a food establishment's history of compliance with this chapter and the establishment's potential as a vector of foodborne illness by evaluating:

1. Past performance for nonconformance with this chapter or HACCP plan requirements that are critical priority items or priority foundation items;

2. Past performance for numerous or repeat violations of this chapter or HACCP plan requirements that are noncritical core items;

3. Past performance for complaints investigated and found to be valid;

4. The hazards associated with the particular foods that are prepared, stored, or served;

5. The type of operation including the methods and extent of food storage, preparation, and service;

6. The number of people served; and

7. Whether the population served is a highly susceptible population.

[ 2VAC5-585-3815. Competency of personnel inspectors.

A. An authorized representative of the commissioner who inspects a food establishment or conducts plan review for compliance with this regulation shall have the knowledge, skills, and ability to adequately perform the required duties.

B. The department shall ensure that authorized representatives who inspect a food establishment or conduct plan review for compliance with this chapter have access to training and continuing education as needed to properly identify violations and apply the chapter. ]

2VAC5-585-3820. Access allowed at reasonable times.

After the authorized representative of the commissioner presents official credentials and identifies provides notice of the purpose of, and an intent to conduct, an inspection, the person in charge shall allow the authorized representative to determine if the food establishment is in compliance with this chapter by allowing access to the establishment, allowing inspection, and providing information and records specified in this chapter and to which the department is entitled according to law, during the food establishment's hours of operation and other reasonable times.

2VAC5-585-3830. Refusal, notification of right to access, and final request for access.

If a person denies access to the authorized representative of the commissioner, the authorized representative shall:

1. Inform the person that:

a. The person is required to allow access to the authorized representative as specified under 2VAC5-585-3820;

b. If access is denied, the The department will refer the matter to the Commonwealth's Attorney for handling in accordance with applicable sections of the Code of Virginia; and

2. Make a final request for access.

2VAC5-585-3840. Refusal, reporting.

If after the authorized representative of the commissioner presents credentials and identifies the purpose of and the intent to conduct an inspection provides notice as specified under 2VAC5-585-3820, explains the authority upon which access is requested, and makes a final request for access as specified in 2VAC5-585-3830, the person in charge continues to refuse access, the authorized representative shall provide details of the denial of access on an inspection report form.

2VAC5-585-3860. Documenting information and observations.

The authorized representative of the commissioner shall document on an inspection report form:

1. Administrative information about the food establishment's legal identity, street and mailing addresses, type of establishment and operation, inspection date, and other information such as type of water supply and sewage disposal, and personnel certificates that may be required; and

2. Specific factual observations of violative conditions or other deviations from this chapter that require correction by the establishment operator including:

a. Failure of the person in charge to demonstrate the knowledge of foodborne illness prevention, application of HACCP principles, and the requirements of this chapter specified under 2VAC5-585-60;

b. Failure of food employees, conditional employees, and the person in charge to demonstrate their knowledge of their responsibility to report a disease or medical condition as specified under 2VAC5-585-80 B and D;

c. Nonconformance with critical items priority items and priority foundation items of this chapter;

d. Failure of the appropriate food employees to demonstrate their knowledge of, and ability to perform in accordance with, the procedural, monitoring, verification, and corrective action practices required by the department as specified under 2VAC5-585-60 2VAC5-585-3542;

e. Failure of the person in charge to provide records required by the department for determining conformance with a HACCP plan as specified under subdivision 4 f of 2VAC5-585-3630; and

f. Nonconformance with critical limits of a HACCP plan.

2VAC5-585-3910. Imminent health hazard, ceasing operations and reporting.

A. Except as specified in subsection B of this section, an operator shall immediately discontinue operations and notify the department if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross insanitary occurrence or condition, or other circumstance that may endanger public health.^P

B. An operator need not discontinue operations in an area of an establishment that is unaffected by the imminent health hazard.

2VAC5-585-3930. Critical violation Priority or priority foundation item, timely correction.

A. Except as specified in subsection B of this section, an operator or person in charge shall at the time of inspection correct a critical violation of a priority item or priority foundation item of this chapter and implement corrective actions for a HACCP plan provision that is not in compliance with its critical limit.^Pf

B. Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the department may agree to or specify a longer time frame, not to exceed 10 calendar days after the inspection, for the operator or person in charge to correct critical violations or HACCP plan deviations.:

1. 72 hours after the inspection, for the operator to correct violations of a priority item; or

2. 10 calendar days after the inspection, for the operator to correct violations of a priority foundation item or HACCP plan deviations.

2VAC5-585-3940. Verification and documentation of correction.

A. After observing at the time of inspection a correction of a critical violation or of a priority item or priority foundation item or a HACCP plan deviation, the authorized representative of the commissioner shall enter the violation and information about the corrective action on the inspection report.

B. As specified under 2VAC5-585-3930 B, after receiving notification that the operator has corrected a violation of a priority item or priority foundation item or HACCP plan deviation, or at the end of the specified period of time, the authorized representative shall verify correction of the critical violation or deviation during the next scheduled inspection of the establishment and shall document the information on an inspection report, and enter the report in the department's records.

2VAC5-585-3950. Noncritical violation Core items, time frame for timely correction.

A. Except as specified in subsection B of this section, the operator or person in charge shall correct noncritical violations core items by a date and time agreed to or specified by the department but no later than 90 calendar days after the inspection.

B. The department may approve a compliance schedule that extends beyond the time limits specified under subsection A of this section if a written schedule of compliance is submitted by the operator and no health hazard exists or will result from allowing an extended schedule for compliance.

Article 5
Prevention of Foodborne Disease Transmission by Employees

2VAC5-585-4040. Investigation and control, obtaining information: personal history of illness, medical examination, and specimen analysis.

The department shall act when it has reasonable cause to believe that a food employee or conditional employee has possibly transmitted disease; may be infected with a disease in a communicable form that is transmissible through food; may be a carrier of infectious agents that cause a disease that is transmissible through food; or is affected with a boil, an infected wound, or acute respiratory infection, by:

1. Securing a confidential medical history of the food employee or conditional employee suspected of transmitting disease or making other investigations as deemed appropriate; and

2. Requiring appropriate medical examinations, including collection of specimens for laboratory analysis, of a suspected food employee and other employees or conditional employee.

2VAC5-585-4050. Restriction or exclusion of food employee.

Based on the findings of an investigation related to a food employee or conditional employee who is suspected of being infected or diseased, the department may request that issue an order to the suspected food employee, or conditional employee, or operator institute instituting one or more of the following control measures:

1. Restricting the food employee or conditional employee; or

2. Excluding the food employee or conditional employee; or

3. Closing the food establishment in accordance with law.

2VAC5-585-4060. Restriction or exclusion request: information required.

Based on the findings of the investigation as specified in 2VAC5-585-4040 and to control disease transmission, the department may make a request issue an order of restriction or exclusion to the suspected food employee or the operator regarding restriction or exclusion if the request without prior warning, notice of hearing, or a hearing if the order:

1. States the reasons for the restriction or exclusion that is requested ordered;

2. States the evidence that the food employee or operator shall provide in order to demonstrate that the reasons for the restriction or exclusion are eliminated;

3. States that the suspected food employee or the operator may request an appeal hearing by submitting a timely request as provided in law; and

4. Provides the name and address of the authorized representative of the commissioner to whom a request for appeal hearing be made.

FORMS (2VAC5-585)

Food Safety and Security Program, Inspection Report

Food Safety and Security Program, Record of Complaint

Food Safety and Security Program, Record of Complaint, FBI

Food Safety and Security Program, Sample Collection Report

Food Safety and Security Program, Retail Inspection Report, ODF-FSSP-10001 (rev. 9/14)

Food Safety and Security Program, Complaint Report, ODF-FSSP-10004 (rev. 12/13)

Food Safety and Security Program, Foodborne Illness Complaint Report, ODF-FSSP-10003 (rev. 12/13)

Food Safety and Security Program, Sample Collection Report, ODF-FSSP-10002 (rev. 12/13)

DOCUMENTS INCORPORATED BY REFERENCE (2VAC5-585)

Approved Drug Products with Therapeutic Equivalence Evaluations (updated daily), 25th Edition, available from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs at http://www.fda.gov/cder/ob/default.htm.

Grade "A" Pasteurized Milk Ordinance, 2003 Revision, published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Grade "A" Condensed and Dry Milk Ordinance, 1995 Revision, published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835

Approved Drug Products with Therapeutic Equivalence Evaluations, 34th Edition, 2014, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs at http://www.fda.gov/cder/ob/default.htm

Grade "A" Pasteurized Milk Ordinance, 2013 Revision, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, MD 20740-3835

Interstate Certified Shellfish Shippers List (updated monthly), published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Seafood (HFS-417), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish (2007), published by the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Seafood (HFS-417), 5100 Paint Branch Parkway, College Park, MD 20740-3835.

NSF/ANSI 18-2006 Manual Food and Beverage Dispensing Equipment, American National Standard, published by NSF International, 789 North Dixboro Road, P.O. Box 130140, Ann Arbor, Michigan 48113-0140.

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, [ 2011 2013 ] Revision, U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Office of Seafood (HFS-417), 5100 Paint Branch Parkway, College Park, MD 20740-3835

NSF/ANSI 18-2012 Manual Food and Beverage Dispensing Equipment, 2012, NSF International, 789 North Dixboro Road, P.O. Box 130140, Ann Arbor, MI 48113-0140, www.nsf.org

Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, Conference for Food Protection, 30 Elliott Court, Martinsville, IN 46151-1331

United States Standards, Grades, and Weight Classes for Shell Eggs, AMS-56, effective July 20, 2000, U.S. Department of Agriculture, Agricultural Marketing Service, Poultry Programs, STOP 0259, Room 3944-South, 1400 Independence Avenue, SW, Washington, DC 20250-0259