Title of Regulation: 2VAC5-585. Retail Food Establishment Regulations (amending 2VAC5-585-20, 2VAC5-585-30, 2VAC5-585-40, 2VAC5-585-50, 2VAC5-585-65, 2VAC5-585-67, 2VAC5-585-80, 2VAC5-585-180, 2VAC5-585-255, 2VAC5-585-300, 2VAC5-585-310, 2VAC5-585-330, 2VAC5-585-400, 2VAC5-585-410, 2VAC5-585-440, 2VAC5-585-470, 2VAC5-585-540, 2VAC5-585-700, 2VAC5-585-720, 2VAC5-585-730, 2VAC5-585-740, 2VAC5-585-790, 2VAC5-585-820, 2VAC5-585-850, 2VAC5-585-870, 2VAC5-585-880, 2VAC5-585-950, 2VAC5-585-980, 2VAC5-585-1180, 2VAC5-585-1190, 2VAC5-585-1230, 2VAC5-585-1300, 2VAC5-585-1310, 2VAC5-585-1430, 2VAC5-585-1435, 2VAC5-585-1535, 2VAC5-585-1620, 2VAC5-585-1700, 2VAC5-585-1780, 2VAC5-585-1900, 2VAC5-585-2100, 2VAC5-585-2120, 2VAC5-585-2190, 2VAC5-585-2200, 2VAC5-585-2230, 2VAC5-585-2270, 2VAC5-585-2320, 2VAC5-585-2520, 2VAC5-585-2570, 2VAC5-585-2750, 2VAC5-585-2790, 2VAC5-585-3390, 2VAC5-585-3510, 2VAC5-585-3520, 2VAC5-585-3540, 2VAC5-585-3541, 2VAC5-585-3542, 2VAC5-585-3630, 2VAC5-585-3800, 2VAC5-585-3815, 2VAC5-585-3820, 2VAC5-585-3860, 2VAC5-585-3910, 2VAC5-585-3940, 2VAC5-585-9998, 2VAC5-585-9999; adding 2VAC5-585-235, 2VAC5-585-3740, 2VAC5-585-3750; repealing 2VAC5-585-3655, 2VAC5-585-3660).

Statutory Authority: § 3.2-5121 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: June 9, 2021.

Effective Date: June 24, 2021.

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, TDD (800) 828-1120, or email ryan.davis@vdacs.virginia.gov.

Basis: Section 3.2-109 of the Code of Virginia establishes the Board of Agriculture and Consumer Services as a policy board with the authority to adopt regulations in accordance with the provisions of Title 3.2 of the Code of Virginia. Section 3.2-5121 of the Code of Virginia provides the legal basis for the promulgation and modification of this regulation.

Purpose: This regulation is essential to the protection of the health and welfare of citizens in that it sets the necessary standards of operation for the retail segment of Virginia's food industry to (i) provide a system of prevention and overlapping safeguards designed to minimize foodborne illness; (ii) ensure employee health; industry manager knowledge; safe food; equipment that is used, easily cleaned, and kept in a sanitary condition; and acceptable levels of sanitation for food establishments; and (iii) promote fair dealings with the consumer. The regulation is essential in order to provide a regulatory framework necessary to educate the industry and protect the public.

The first goal of the regulation and the proposed amendments is to maintain a scientifically sound basis for regulation of the retail food industry. The modifications proposed to the existing regulation are necessary to ensure appropriate measures are in place to address emerging and ongoing food safety concerns that exist within an evolving food industry.

The second goal is to facilitate the shared responsibility of the food industry and the government in ensuring that food provided to the consumer is safe and does not become a vehicle in a disease outbreak or in the transmission of communicable disease. Foodborne disease in the United States is a major cause of personal distress, preventable death, and avoidable economic burden. The U.S. Centers for Disease Control and Prevention estimate that foodborne diseases cause approximately 48 million people to become ill, 128,000 hospitalizations, and 3,000 deaths each year in the United States. Epidemiological outbreak data repeatedly identify five major risk factors related to employee behaviors and preparation practices in retail and food service establishments as contributing to foodborne illness. Those risk factors include (i) improper holding temperatures; (ii) inadequate cooking, such as undercooking raw eggs; (iii) contaminated equipment; (iv) food from unsafe sources; and (v) poor personal hygiene. The amendments address controls for these risk factors. The regulation also provides the necessary guidance to the retail food industry relative to controlling risk factors and implementing appropriate intervention strategies.

The third goal of the proposed regulation is to ensure a regulatory approach that is uniform throughout the retail segment of Virginia's food industry by administering standards that are equivalent to those administered by the Virginia Department of Health (VDH) in restaurants and food service establishments. This regulatory uniformity also extends throughout the nation, as most states have adopted versions of Food and Drug Administration (FDA) Food Code.

Rationale for Using Fast-Track Rulemaking Process: This regulatory action will update the existing regulation, which is based on FDA's 2013 Food Code and the 2015 Food Code Supplement, so that it is consistent with FDA's 2017 Food Code and the 2019 Food Code Supplement as well as the regulations adopting FDA's Food Code that VDH enforces. The proposed amendments are necessary to address changes that have occurred in the food industry and emerging science relating to the prevention of foodborne illnesses. The new regulations will assist in optimizing public health protection. This regulatory action is expected to be noncontroversial because the proposed amendments were generated from the Conference for Food Protection, which provides a formal process whereby members of industry, regulatory, academia, consumer, and professional organizations are afforded equal input in the modification of the FDA Food Code.

Substance: The proposed changes would: (i) allow an exception for providing a person in charge for certain types of food establishments; (ii) require that the person in charge be a certified food protection manager (CFPM), including exemptions for certain low risk establishments; (iii) require, if used, an impermeable cover such as a bandage located on the wrist, hand, or finger of a food employee be covered with a single-use glove; (iv) add information regarding labeling requirements for commercially slaughtered or processed rabbits; (v) harmonize cooking time/temperature parameters for intact and non-intact meat and poultry in accordance with guidance from U.S. Department of Agriculture (USDA) and add cooking time/temperature for commercially slaughtered rabbits; and (vi) allow the regulatory authority to agree to continuing operation in the event of an extended interruption of electrical or water service if certain conditions are met.

Issues: The primary advantage of the proposed amendments to this regulation for the public is that they will further enhance the safety of food products sold through the retail segment of the food industry. The regulation and the proposed amendments are based on the most current sound science available. Consumers purchasing food products from retail establishments should develop greater confidence in the safety of the retail food supply.

There do not appear to be any disadvantages to the public.

The advantage for regulated business is that the benefits of well-written, scientifically sound, and up-to-date retail food safety requirements have long been recognized by industry and regulatory officials. Industry conformance with acceptable procedures and practices is far more likely where regulatory officials speak with one voice about what is required to protect public health, why it is important, and which alternatives for compliance may be accepted. With both the Virginia Department of Agriculture and Consumer Services (VDACS) and VDH administering equivalent food safety requirements in each agency's respective portion of the retail segment of the food industry, Virginia's regulatory officials will be speaking with one voice, greatly enhancing the uniform application of retail standards and requirements. This will in turn prevent the retail food industry from adhering to separate standards, which will ultimately eliminate confusion and additional costs relative to compliance with two different regulations and will further enhance the industry's ability to comply with existing food safety standards. The standards and requirements of this proposal can also be used by the retail segment of the food industry in training and quality assurance programs.

The requirement that each retail food establishment have a person in charge who is a certified food protection manager (CFPM) may pose an initial disadvantage in that it may require some level of effort by them to ensure the presence of a CFPM at the establishment. However, the designation of a person in charge within each retail food establishment who is knowledgeable regarding food safety will ultimately provide an advantage to each establishment, as taking additional steps to further ensure that food products produced and offered for sale should enhance consumer confidence and ultimately food product sales.

The advantage to the agency and the Commonwealth is that the proposed changes will further ensure the safety of the food supply. This will, in turn, engender a greater level of confidence by the public that both the agency and the Commonwealth are taking the necessary steps to provide an appropriate level of public health protection. This confidence in the food supply should ultimately enhance Virginia's economy via enhanced food product sales.

There do not appear to be any disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

The Board of Agriculture and Consumer Services (Board) proposes numerous amendments to 2VAC5-585, Retail Food Establishment Regulations, mostly for consistency with the latest U.S. Food and Drug Administration (FDA) model regulations, (i.e., the FDA's 2017 Food Code and the 2019 Food Code Supplement).

Background.

The Retail Food Establishment Regulations 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; procedures for vector and pest control; requirements for toilet and hand washing 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 FDA's 2013 Food Code and the 2015 Food Code Supplement.

The FDA describes its Food Code as "a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer." It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service.¹ The FDA encourages states to adopt the latest version of the FDA Food Code,² but it is not federal law.

Conforming to 2017 FDA Food Code and 2019 Food Code Supplement. The following proposed amendments to the regulation conform to requirements in the 2017 FDA Food Code or the 2019 Food Code Supplement:

• Require that the person in charge be a certified food protection manager (CFPM).

• Add an exception to the requirement that a person in charge³ is present at the food establishment during all hours of operation. The exception is proposed for food establishments deemed by the Virginia Department of Agriculture and Consumer Services (VDACS) to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and the extent of the food preparation.

• Require that if used, an impermeable cover such as a bandage, finger cot, or finger stall located on the wrist, hand or finger of the food employee working with exposed food shall be covered with a single-use glove.

• Require that food establishments have written 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 must 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.

• Require the protection of prewashed fruits and vegetables from cross contamination by separating them from raw animal foods during storage, preparation holding and display.

• Increase the minimum required cooking time from 15 to 17 seconds (at 155°F) for certain raw animal foods.⁴

• Reduce the minimum required cooking time from 15 seconds to less than one second (165°F or above) for certain raw animal foods.⁵

• Include timelines for required reporting of nitrate and E. coli positive lab results to VDACS.

• Permit VDACS to allow the continuing operation of food establishments in the event of an extended interruption of electrical or water service if certain conditions are met.

When inspectors find violations of any of the regulation's requirements, the food establishment must correct the deficiencies within specified time periods. All requirements are delineated as priority, priority foundation, or core. Priority items must be remedied within 72 hours, priority foundation items within 10 calendar days, and core items within 90 days. In order to conform to the 2017 FDA Food Code, the Board proposes to decrease the length of time in which certain violations of requirements must be corrected, as follows:

Priority instead of Core (requiring correction within 72 hours instead of 90 calendar days):

• Except during preparation, cooking, or cooling, or when time is used as the public health control,^6,7 time/temperature control for safety food must be maintained at 41°F (5°C) or less.

• Priority Foundation instead of Core (requiring correction within 10 calendar days instead of 90 calendar days):

• Water from a private well must be sampled and tested at least annually for nitrate and total coliform.

• Various specifications for thawing of food.

• Cleaning agents and chemical sanitizer must be provided and available for use during all hours of operation.

Other Proposed Changes. The following proposed amendments to the regulation are not related to the 2017 FDA Food Code or the 2019 Food Code Supplement:

• Specify that shucked shellfish from one tagged or labeled container are not commingled with shellstock⁸ or shucked shellfish 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.

• Require that labels for commercially slaughtered or processed rabbits that are offered for sale or service contain certain specified information, including a producer number, safe handling instructions, identifying code, and a warning statement.

Estimated Benefits and Costs.

Conforming to 2017 FDA Food Code and 2019 Food Code Supplement. The current regulation requires food establishments to employ a CFPM; however, they are not required to be onsite at all times of operation. The proposed regulation expands this time requirement, and effectively requires that a CFPM be onsite at all times of operation. More specifically, the person in charge of the open food establishment would have to be a CFPM. The regulation defines "person in charge" as "the individual present at a food establishment who is responsible for the operation at the time of inspection." Since most food establishments are unlikely to have one person who works 100% of open hours, many would likely need to get one or more additional employees certified.

Under both the existing and proposed regulations, proficiency as a CFPM is established through passing a test, not completing a program. Certification costs (for the test) are approximately $100 per individual⁹ and renewal is required every five years. Tests are available via six accredited programs and take approximately two hours. Those persons who elect to take training (not required) may sign up for a training course via an accredited provider, and the training time varies from self-pace to approximately sixteen hours. Training and tests are available both online and in person.¹⁰ The total cost of requiring that a CFPM be onsite at all times of operation would therefore be: a) the test fees for each additional needed CFPM, b) fees for training if needed to pass the test, and c) the value of the staff time spent preparing for and taking the test. For example, if a CFPM candidate spends eight hours preparing for the test and two hours taking the test, the ten hours of staff time represents a cost that has to be covered by another employee. However, having a CFPM always present in the open operation, who is certified to be knowledgeable about food protection, would likely reduce the probability that unsafe food practices would occur.

The proposal to provide an exception for certain food establishments to the requirement that a person in charge be present during all hours of operation could potentially reduce costs for such establishments; this exception would apply to food establishments deemed by VDACS to pose minimal risk of causing, or contributing to, foodborne illness. For example, such minimal risk establishments would not need incur the cost of additional staff becoming a CFPM. Since by definition these establishments pose minimal risk, the absence of having a CFPM always present in the open operation would not likely substantively affect the probability of unsafe food practices occurring.

The current regulation only requires the use of a single-use glove when "a lesion containing pus such as a boil or infected wound that is open or draining and is on the hands or wrists." The proposed regulation would require that "If used, an impermeable cover such as a bandage, finger cot, or finger stall located on the wrist, hand or finger of the food employee working with exposed food shall be covered with a single use glove." This would include band aids for simple uninfected cuts. Thus, single use gloves would need to be purchased and used more often under the proposed regulation. Single-use gloves are available for about five cents a glove when purchasing in bulk (100 gloves).¹¹

The current regulation requires that food establishments 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 must 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. The Board proposes to specify that those procedures be written. This would help ensure that those procedures are consistent, regardless of whoever is in charge at a given time. VDACS has a template that can be made available to food establishments to use for their written procedures. Thus, it should not be costly for the businesses to produce written procedures that satisfy the department.

The FDA believes that certain requirements would protect food safety: a) protecting prewashed fruits and vegetables from cross contamination by separating them from raw animal foods during storage, preparation holding and display, and b) increasing the minimum required cooking time from 15 to 17 seconds (at 155°F) for certain raw animal foods.¹² For any food establishments that do not already protect prewashed fruits and vegetables from cross contamination in the above manner, there may be some cost in finding additional space to keep these items separated. For establishments that already keep such separation, neither of these two proposals appear to be particularly costly. For other raw animal foods,¹³ which must be cooked at 165°F or above, the FDA believes that it is safe to reduce the minimum required cooking time from 15 seconds to less than one second (instantaneous). The Board's proposal to make this amendment would cumulatively moderately reduce the time necessary to prepare such food without apparently increasing health risks.

The current regulation requires that water from a private well be sampled and tested at least annually for nitrate and total coliform. If nitrate exceeds 10 milligrams per liter, the operator must notify VDACS. If a sample is total coliform positive, the positive culture medium must be further analyzed to determine if E. coli is present. The operator must notify VDACS within two days from when the operator is notified of the coliform positive test result. If E. coli is present, the operator must notify VDACS. The current regulation does not specify deadlines for notification for positive results of either nitrate exceeding 10 mg/L or the presence of E. coli. The Board proposes to specify that notification must be within 24 hours. This would be beneficial in that it would enable VDACS to take faster action regarding a potential health threat.

The proposal to permit VDACS to allow food establishments to continue operating in the event of an extended interruption of electrical or water service if certain conditions are met, would give greater flexibility to retail food establishments to continue operations if they have a written emergency operation plan that has been approved by the department.

Other Proposed Changes. The current regulation specifies that shellstock from one tagged or labeled container are not to be 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. "Shellstock" is defined as "raw, in-shell molluscan shellfish," and thus does not include shucked shellfish. The Board proposes to mandate that shucked shellfish from one tagged or labeled container not be commingled with shellstock or shucked shellfish 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. To the extent that this is not already done by food establishments with shucked shellfish, this proposal would be beneficial in that it would likely reduce the probability that spoiled shellfish is mistakenly sold.

The proposal to require that the labels for commercially slaughtered or processed rabbits that are offered for sale or service contain certain specified information, including a producer number, safe handling instructions, identifying code, and a warning statement may effectively require the size of labels used for such rabbits to be larger (or the use of a smaller font) for those that are not already providing this information. The potential cost for larger labels would not likely be large. The provision of information such as safe handling instructions may reduce the likelihood of illness.

Businesses and Other Entities Affected. The proposed amendments would affect the approximate 9,411 retail food stores in the Commonwealth¹⁴ and the six accredited CFPM programs.¹⁵ As described in the Estimated Benefits and Costs section, the proposal to require that there be a CFPM on the premises of the food establishment at all times of operation would likely increase costs for most food establishments. The proposal to mandate that single-use gloves be worn whenever there is an impermeable cover such as a bandage, finger cot, or finger stall located on the wrist, hand, or finger of the food employee would also modestly increase costs for most food establishments.

Adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. While the benefits to public health may be large, there would likely be some increases in net costs for some of the affected entities as described in the Estimated Benefits and Costs section.

Small Businesses¹⁶ Affected:

Types and Estimated Number of Small Businesses Affected. VDACS estimates that 4,705 of the retail food stores in the Commonwealth are small businesses. The sizes of the six accredited CFPM programs are unknown.

Costs and Other Effects. Costs for small food establishments would be affected by the proposed amendments as described in the Estimated Benefits and Costs section. The proposal to require that there be a CFPM on the premises of the food establishment at all times of operation would very likely increase revenue for at least some of the six accredited CFPM programs.

Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both reduce adverse impact and meet the intended policy goals.

Localities¹⁷ Affected.¹⁸ The proposed amendments would affect food establishments in all localities, not disproportionately affecting any particularly. The proposed amendments do not appear to introduce additional costs for local governments.

Projected Impact on Employment. The proposal to require that there be a CFPM on the premises of the food establishment at all times of operation would very likely increase demand for the services of the six accredited CFPM programs, which may moderately increase their employment.

Effects on the Use and Value of Private Property. The proposals to require that there be a CFPM on the premises of the food establishment at all times of operation and that single-use gloves be worn whenever there is an impermeable cover on the wrist, hand, or finger of the food employee would likely increase costs for most food establishments. These cost increases would likely moderately reduce the value of affected firms commensurately.

The proposal to require that there be a CFPM on the premises of the food establishment at all times of operation would very likely increase demand for the services of the six accredited CFPM programs, which may moderately increase their value.

The proposed amendments do not appear to affect real estate development costs.

____________________

¹See https://www.fda.gov/food/fda-food-code/food-code-2017

²Ibid

³"Person in charge" is defined as the individual present at a food establishment who is responsible for the operation at the time of inspection.

⁴See 2VAC5-585-700 A 2 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14682&replace=yes

⁵See 2VAC5-585-700 A 3 for affected raw animal foods.

⁶See 2VAC5-585-850 for time is used as the public health control https://law.lis.virginia.gov/admincode/title2/agency5/chapter585/section850/

⁷The situations described in 2VAC5-585-820 B and C would also be excepted: https://law.lis.virginia.gov/admincode/title2/agency5/chapter585/section820/

^8"Shellstock" is defined as "raw, in-shell molluscan shellfish."

⁹Source: VDACS

¹⁰Data and other information source: Virginia Department of Health (VDH)

¹¹Source: Amazon.com accessed on March 13, 2020.

¹²See 2VAC5-585-700 A 2 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14682&replace=yes

¹³See 2VAC5-585-700 A 3 for affected raw animal foods.

¹⁴Source: VDACS

¹⁵Source: VDH

¹⁶Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

¹⁷"Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹⁸§ 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency's Response to the Economic Impact Analysis: The agency concurs with the economic impact analysis of the Department of Planning and Budget.

Summary:

The amendments update the current regulation so that it is consistent with the Food and Drug Administration's 2017 Food Code and the 2019 Food Code Supplement. Many of the changes simply refine and clarify provisions in the existing regulation. Substantive amendments include (i) providing an exemption from the requirement that a food establishment have a person in charge present during all hours of operation for certain types of food establishments; (ii) requiring that the person in charge be a Certified Food Protection Manager and providing exemptions for certain low risk establishments; (iii) requiring an impermeable cover, such as a bandage, that is located on the wrist, hand, or finger of a food employee be covered with a single-use glove; (iv) labeling requirements for commercially slaughtered or processed rabbits; (v) harmonizing cooking time/temperature parameters for intact and non-intact meat and poultry in accordance with guidance from the U.S. Department of Agriculture and adding cooking time/temperature for commercially slaughtered rabbits; and (vi) allowing the regulatory authority to allow the continued operation of a food establishment in the event of an extended interruption of electrical or water service if certain conditions are met.

2VAC5-585-20. Food safety, illness prevention, and honest presentation.

The purpose of this regulation chapter is to safeguard public health and provide to consumers food that is safe, unadulterated, and honestly presented.

2VAC5-585-30. Statement.

This regulation chapter establishes definitions; sets standards for management and personnel, food operations, and equipment and facilities; and provides for inspection, food establishment plan review, and employee restriction.

2VAC5-585-40. Definitions.

The following words and terms when used in this 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 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 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 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" 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.

"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 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.

"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 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 (SSOPs), 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 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 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, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

"Dry storage area" means a room or area designated for the storage of packaged or containerized bulk food that is not 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.

"EPA" means the U.S. Environmental Protection Agency.

"Equipment" means an article that is used in the operation of a food establishment, 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 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 an employee in a food establishment or entering a food establishment as an employee.

"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;, and all mollusks, if such animal life is intended for human consumption; and includes any an 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" means an operation that (i) stores, prepares, packages, serves, vends food directly to the consumer, or otherwise 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 takeout orders, or delivery service that is provided by common carriers.

"Food establishment" 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 unless the vending or satellite feeding location is inspected by the regulatory authority 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" does not include:

1. An establishment that offers only prepackaged foods that are not 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."

"Game animal" means an animal, the products of which are food, that is not classified as (i) livestock, sheep, swine, goat, horse, mule, or other equine in 9 CFR 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.

"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 Grade "A" Pasteurized Milk Ordinance, 2013 2017 Revision, (U.S. Food and Drug Administration) with which certain fluid and dry milk and milk products comply.

"HACCP plan" means a written document that delineates the formal procedures for following the Hazard Analysis and 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 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 manipulating meat to which a solution has been introduced into its interior by processes such as that are referred to as "injecting," "pump marinating," or "stitch pumping."

"Intact meat" means a cut of whole muscle meat that has not undergone comminution, vacuum tumbling with solutions, mechanical tenderization, or reconstruction.

"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).

"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.

"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. by piercing with a set of needles, pins, blades, or any mechanical device that breaks up muscle fiber and tough connective tissue to increase tenderness. This includes injection, scoring, and processes that may be referred to as "blade tenderizing," "jaccarding," "pinning," or "needling."

"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, bagged, or wrapped, whether packaged in a food establishment or a food processing plant. "Packaged" does not include 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 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.

"Poultry" means any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs), whether live or dead, as defined in 9 CFR 381.1 and any migratory waterfowl, game bird, pheasant, partridge, quail, grouse, or pigeon, whether live or dead, as defined in 9 CFR 362.1.

"Premises" means the physical facility, its contents, and the contiguous land or property under the control of the operator 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 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," which looks like this: ^Pf.

"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," which looks like this: ^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.

"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 2VAC5-585-700 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 2VAC5-585-700 D 1 and D 3; or (iii) is prepared in accordance with a variance that is granted as specified under 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 Plant food that are is cooked for hot holding as specified under 2VAC5-585-720;

4. All 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 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 as specified in 21 CFR Part 113.

"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;

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 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, 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 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 of the Federal Food, Drug, and Cosmetic Act (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 surfaces that, when evaluated for efficacy, is sufficient to yield a 5-log reduction, 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 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. "Sewage" includes water-carried and non-water-carried human excrement or kitchen, laundry, shower, bath, or lavatory waste separately or together with such underground surface, storm, or other water and liquid industrial wastes as may be present from residences, buildings, vehicles, industrial establishments, or other places.

"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" or "STEC" means any E. coli capable of producing Shiga toxins (also called 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: 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 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 electronic transaction or 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 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.

"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 pure 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.

2VAC5-585-50. Assignment.

A. Except as specified in subsection B or C 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

C. This section does not apply to certain types of food establishments deemed by the department to pose minimal risk of causing, or contributing to, foodborne illness based on the nature of the operation and the extent of the food preparation.^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. The person in charge 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. For purposes of enforcing this subsection, this requirement will take effect on June 24, 2023.

C. This section does not apply to certain types of food establishments deemed by the regulatory authority department 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 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 Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs, April 2012 2018, (Conference for Food Protection) is deemed to comply with subdivision 2 of 2VAC5-585-60.

B. A food establishment that has an employee a person in charge 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 Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs, April 2012, 2018, (Conference for Food Protection) is deemed to comply with 2VAC5-585-65.

2VAC5-585-80. Responsibility of operator, person in charge, and conditional employees.

A. The 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. Shiga toxin-producing Escherichia coli; ^P

e. Typhoid fever (caused by Salmonella typhi);^P or

f. Salmonella (nontyphoidal);^P

3. Had typhoid fever, diagnosed by a health practitioner, within the past three months due to Salmonella 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. Shiga toxin-producing Escherichia coli, or Shigella spp. within the past three days of the last exposure;^P

c. 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. Shiga toxin-producing Escherichia coli or Shigella spp. within the past three days of the last exposure;^P

c. 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 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 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 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 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 subsection A of this section is:

1. Excluded as specified under subdivisions 1 through 3 and 4 a, 5 a, 6 a, 7, or 8 a of 2VAC5-585-90 and in compliance with the provisions specified under subdivisions 1 through 8 of 2VAC5-585-100;^P or

2. Restricted as specified under subdivision 4 b, 5 b, 6 b, 8 b, 9, or 10 of 2VAC5-585-90 and in compliance with the provisions specified under subdivisions 4 through 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, 7, or 8 a of 2VAC5-585-90, and with the provisions specified under subdivisions 1 through 8 of 2VAC5-585-100;^P or

2. Comply with a restriction specified under subdivision 4 b, 5 b, 6 b, 7, or 8 b of 2VAC5-585-90 or under subdivision 8, 9, or 10 of 2VAC5-585-90 and comply with the provisions specified under subdivisions 4 through 10 of 2VAC5-585-100.^P

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 "Approved Drug Products with Therapeutic Equivalence Evaluations, 34th 39th Edition," 2014, 2019 (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) 82 FR 60474 (December 20, 2017) as an antiseptic handwash;^Pf

2. Consist only of components that the intended use of each complies with one of the following:

a. A threshold of regulation exemption under 21 CFR 170.39; ^Pf

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 mg/l (ppm) chlorine.^Pf

2VAC5-585-235. Use of bandages, finger cots, or finger stalls.

If used, an impermeable cover such as a bandage, finger cot, or finger stall located on the wrist, hand, or finger of a food employee working with exposed food shall be covered with a single-use glove.

2VAC5-585-255. Clean-up of vomiting and diarrheal events.

A. A food establishment shall have written 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

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 National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2013 2017 Revision, (U.S. Food and Drug Administration).^P

B. Molluscan shellfish shall be from sources that are listed in the "Interstate Certified Shellfish Shippers List," updated monthly List" (U.S. Food and Drug Administration).^P

2VAC5-585-330. Game animals.

A. If game animals are received for sale or service they shall be:

1. Commercially raised for food and raised, slaughtered, and processed under a voluntary inspection program that is conducted by the state agency that has animal health jurisdiction or under a voluntary inspection program administered by the USDA for game animals such as exotic animals (i.e., reindeer, elk, deer, antelope, water buffalo, or bison) that are "inspected and approved" in accordance with 9 CFR Part 352;^P

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

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; ^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.

C. The requirements of subsection A of this section shall not apply to commercially slaughtered or processed rabbits that are offered for sale or service.

D. Commercially slaughtered or processed rabbits that are offered for sale or service shall be packaged with a label that complies with 2VAC5-585-900 B and includes the following information:

1. Producer number;

2. Safe handling instructions, as required by 9 CFR 317.2(l) and 9 CFR 381.125(b);

3. An identifying code that is permanently visible to the naked eye to aid in traceback throughout sale and distribution; and

4. The statement: "WARNING: EXEMPT FROM CARCASS INSPECTION. PREPARED IN COMPLIANCE WITH THE VIRGINIA RABBIT PROGRAM." on the principal display panel.

E. An entity commercially slaughtering or processing rabbits that are offered for sale or service may elect to participate in a voluntary inspection program that is conducted by the state agency that has animal health jurisdiction or a voluntary inspection program that is administered by USDA. The requirements of subsection D of this section shall not apply to commercially slaughtered or processed rabbits that are offered for sale or service that bear a mark of inspection and that are under a voluntary inspection program that is conducted by the state agency that has animal health jurisdiction or that is administered by USDA.

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, 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 64 fluid ounces (1.89 L) or the date shucked for packages with a capacity of one-half gallon 64 fluid ounces (1.89 L) or more.^Pf

B. A package of raw shucked shellfish that does not bear a label or 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).

2VAC5-585-410. Shellstock identification.

A. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by the dealer that depurates, ships, or reships the shellstock, as specified in the National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 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. The dealer's name and address, and the certification number assigned by the shellfish control authority;^Pf

2. The original shipper's certification number assigned by the shellfish control authority;^Pf

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;^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 or country of harvest;^Pf

6. The type and quantity of shellstock;^Pf

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" "THIS TAG (or LABEL) IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR IS RETAGGED AND THEREAFTER KEPT ON FILE IN CHRONOLOGICAL ORDER FOR 90 DAYS." "RETAILERS: DATE WHEN LAST SHELLFISH FROM THIS CONTAINER SOLD OR SERVED (INSERT DATE)";^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) and § 28.2-801 of the Code of Virginia.

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 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 or shucked shellfish from one tagged or labeled container are not commingled with shellstock or shucked shellfish 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

2VAC5-585-470. Packaged and unpackaged food - separation, packaging, and segregation.

A. Food shall be protected from cross contamination by:

1. Except as specified in subdivision 1 c of this subsection, subsection C of this section, 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;^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 Fruits or vegetables before they are washed;

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; ^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.

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.

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 2VAC5-585-1860 and sanitized as specified under 2VAC5-585-1885, 2VAC5-585-1890, and 2VAC5-585-1900; ^P

2. Single-service and single-use articles;^P 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

2VAC5-585-700. 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 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 intact meat, including game animals commercially raised for food and under a voluntary inspection program as specified under 2VAC5-585-330 A 1;^P

2. 155°F (68°C) for 15 17 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 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 less than one second (instantaneous) for poultry, baluts, wild game animals as specified under 2VAC5-585-330 A 2 and 3, commercially raised rabbits as specified under 2VAC5-585-330 C, stuffed fish, stuffed meat, stuffed pasta, stuffed poultry, stuffed ratites, or stuffing containing fish, meat, 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 As specified in the following chart and that is held at chart, to heat all parts of the food to a temperature and for the holding time that corresponds to that temperature;^{Pf P} and

	Oven Temperature Based on Roast Weight
Oven Type	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

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.

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.

If cooked in an oven, use 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

	Oven Temperature Based on Roast Weight
Oven Type	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

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, whole-muscle, intact beef"; 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;

2. The food, if served or offered for service by consumer selection from a children's menu, does not contain comminuted meat;^Pf and

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

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 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.

2VAC5-585-720. Plant food cooking for hot holding.

Fruits and vegetables Plant foods that are cooked for hot holding shall be cooked to a temperature of 135°F (57°C).^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 adductor 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 tuna, Northern);

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 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 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

2VAC5-585-790. Thawing.

A. Except as specified in subdivision 4 of this subsection, time/temperature control for safety food shall be thawed:

1. Under refrigeration that maintains the food temperature at 41°F (5°C) or less;^Pf

2. Completely submerged under running water:

a. At a water temperature of 70°F (21°C) or below;^Pf

b. With sufficient water velocity to agitate and float off loose particles in an overflow;^Pf 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);^Pf 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) 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;^Pf or

(2) The time it takes under refrigeration to lower the food temperature to 41°F (5°C);^Pf

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;^Pf or

b. Thawed in a microwave oven and immediately transferred to conventional cooking equipment, with no interruption in the process;^Pf 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.

2VAC5-585-820. 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, and except as specified under subsections B and C of this section, time/temperature control for safety 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 41°F (5°C) or less.^P

B. 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. Time/temperature control for safety 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.

2VAC5-585-850. 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 time/temperature control for safety food before cooking, or for ready-to-eat, time/temperature control for safety food that is displayed or held for sale or service. Written, written procedures shall be prepared in advance, maintained in the food establishment, and made available to the department upon request that specify:^Pf

1. Methods of compliance with subdivisions B 1, 2, and 3 or subsection B or C of this section;^Pf and

2. 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 four hours:

1. The Except as specified in subdivision B 2 of this section, 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 may have an initial temperature of 70°F (21°C) or less if:

a. It is a ready-to-eat (i) fruit or vegetable that, upon cutting, is rendered a time/temperature control for safety food or (ii) hermetically sealed food that, upon opening, is rendered a time/temperature control for safety food;

b. The food temperature does not exceed 70°F (21°C) within a maximum time period of four hours from the time it was rendered a time/temperature control for safety food; and

c. The food is marked or otherwise identified to indicate the time that is four hours past the point in time when the food is rendered a time/temperature control for safety food as specified in subdivision B 2 a of this section.

3. The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within four hours from marked or otherwise identified to indicate the time that is four hours past (i) the point in time when the food is removed from temperature control;^P and or (ii) the time that the food becomes a time/temperature control for safety food;^Pf

4. The food in unmarked containers or packages or marked to exceed a four-hour limit shall be discarded.^P 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

5. 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 subsection A, B, or C of this section as the public health control for raw eggs.

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, a food establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.^P

B. Except as specified in subsection F E of this section, a food establishment that packages time/temperature control for safety food using a reduced oxygen packaging method shall implement a HACCP plan that contains the information specified under subdivisions 3 and 4 of 2VAC5-585-3630 and that:^Pf

1. Identifies food to be packaged;^Pf

2. Except as specified in subsections C, D, and E 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 and is received in an intact package,^Pf or

d. Is a food with a high level of competing organisms such as raw meat, raw poultry, or raw vegetables;^Pf or

e. Is a cheese that is commercially manufactured in a food processing plant with no ingredients added in the food establishment and that meets the Standards of Identity as specified in 21 CFR 133.150, 21 CFR 133.169, or 21 CFR 133.187;^P

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 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. 2. Limits the refrigerated shelf life to no more than 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. 3. 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 surfaces; ^Pf and

d. Describe 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

(1) Maintain the food at 41°F (5°C) or below,^Pf and

(2) Discard the food if, within 30 calendar days of its packaging, it is not served for on-premises consumption or consumed, if served or sold for off-premises consumption; ^Pf

6. 4. 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 3 of this subsection and subdivisions 3 and 4 of 2VAC5-585-3630;^Pf and

7. 5. 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 and that bears a label indicating that it is to be kept frozen until time of use, a food establishment may not package fish using a reduced oxygen packaging method.^P

D. Except as specified in subsections C and F E of this section, a food establishment that packages time/temperature control for safety food using a cook-chill or sous vide process shall:

1. Provide to the department prior to implementation, a HACCP plan that contains the information as specified under subdivisions 3 and 4 of 2VAC5-585-3630;^Pf

2. 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 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 2VAC5-585-765;^P

d. Placed in a package with an oxygen barrier and sealed before cooking, or placed in a package 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 ^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 calendar days after the date of packaging;^P

(2) Held at 41°F (5°C) or less for no more than seven calendar days, at which time the food must be consumed or discarded;^P or

(3) 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 at 41°F (5°C) or less for no more than seven calendar days, not to exceed 30 calendar days from its date of packaging, at which time the food must be consumed or discarded;^P or

(4) 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. Maintain the records required to confirm that cooling and cold holding refrigeration time/temperature parameters are required as part of the HACCP plan and:

a. Make such records available to the department upon request;^Pf and

b. Hold such records for at least six months;^Pf and

4. Implement written operational procedures as specified under subdivision B 5 3 of this section and a training program as specified under subdivision B 6 4 of this section.^Pf

E. Except as specified under subsection F of this section, a food establishment that packages cheese using a reduced oxygen packaging method shall:

1. 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, 21 CFR 133.169, or 21 CFR 133.187;^P

2. Have a HACCP plan that contains the information specified in subdivisions 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. 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 occurs first;^Pf and

4. 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. E. 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.

2VAC5-585-880. Standards of identity.

Packaged food shall comply with standard of identity requirements in 21 CFR Parts 131-169 and 9 CFR Part 319, Definitions and Standards of Identity or Composition, and the general requirements in 21 CFR Part 130, Food Standards: General, and 9 CFR Part 319, Subpart A, General.

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 nine years or 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) 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 3 through 5 of 2VAC5-585-3630 and as specified in 21 CFR 120.24.^P

2. Pasteurized eggs or egg products shall be substituted for raw 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 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 growth is controlled before and after cooking; and

(b) Salmonella Enteritidis is destroyed by cooking the eggs according to the temperature and time specified in 2VAC5-585-700 A 2;

d. (4) Contains the information specified under subdivision 4 5 of 2VAC5-585-3630 including procedures that:

(1) (a) Control cross contamination of ready-to-eat food with raw eggs; and

(2) (b) Delineate cleaning and sanitization procedures for food-contact surfaces; and

e. (5) 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 Food may not be re-served under the following conditions:

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.

b. Packages of food from any patients, clients, or other consumers should not be re-served to persons in protective environment isolation.

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) (ppm)
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 surface.^P

C. Solder and flux containing lead in excess of 0.2% may not be used as a food-contact surface.

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 ± plus or minus 2°F in the intended range of use.^Pf

B. Food temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius and Fahrenheit shall be scaled in 1°C increments accurate to ± plus or minus 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 only 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 ± plus or minus 3°F in the intended range of use.^Pf

B. Ambient air and water temperature measuring devices that are scaled only in Celsius or dually scaled in Celsius and Farenheit shall be scaled in 1.5°C increments designed to be easily readable and accurate to ± plus or minus 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 time/temperature control for safety food in homogenous liquid form is maintained outside of the temperature control requirements as specified in 2VAC5-585-820 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 18-2012 18-2016 Manual Food and Beverage Dispensing Equipment, 2012 2016, (NSF International).^P

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 store or 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 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 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 time/temperature control for safety 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 (2VAC5-585-260 et seq.) of this chapter.^P

B. When the automatic shutoff within a machine vending time/temperature control for safety food is activated:

1. In a refrigerated vending machine, the ambient temperature may not exceed 41°F (5°C) 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

2VAC5-585-1430. Vending machine doors and openings.

A. Vending machine doors and access opening covers to food and container storage spaces shall be tight-fitting so that the space along the entire interface between the doors or covers and the cabinet of the machine, if the doors or covers are in a closed position, is no greater than one-sixteenth inch or 1.5 millimeters by:

1. Being covered with louvers, screens, or materials that provide an equivalent opening of not greater than one-sixteenth inch or 1.5 millimeters. Screening of 12 mesh to one inch (12 or more mesh to 2.5 centimeters) meets this requirement;

2. Being effectively gasketed;

3. Having interface surfaces that are at least one-half inch wide or 13 millimeters; or

4. Jambs or surfaces used to form an L-shaped entry path to the interface.

B. Vending machine service connection openings through an exterior wall of a machine shall be closed by sealants, clamps, or grommets so that the openings are no larger than 1.5 millimeters or one-sixteenth inch or 1.5 millimeters.

2VAC5-585-1435. Food equipment, certification and classification.

Food equipment that is certified or classified for sanitation in conformance to a recognized American National Standard 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.

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.^Pf

B. Except for chemical sanitizers those 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.^Pf

2VAC5-585-1620. Warewashing sinks, use limitation.

A. A warewashing sink may not be used for handwashing as specified under 2VAC5-585-170.

B. If a warewashing sink is used to wash wiping cloths, wash produce, or thaw food, the sink shall be cleaned as specified under 2VAC5-585-1600 before and after each time it is used to wash wiping cloths or wash produce or thaw food. Sinks used to wash or thaw food shall be sanitized as specified under Article 7 (2VAC5-585-1880 et seq.) (2VAC5-585-1885 et seq.) of this part before and after using the sink to wash produce or thaw food.

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 contact times specified under subdivision 3 of 2VAC5-585-1900 shall 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 8.0 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 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) 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 (ppm) hardness or less or in water having a hardness no greater than specified by the 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 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 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

2VAC5-585-1780. 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 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 surface or utensil is in contact with a succession of different types of raw meat and poultry each requiring a higher cooking temperature as specified under 2VAC5-585-700 than the previous type.

C. Except as specified in subsection D of this section, if used with 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 time/temperature control for safety food may be cleaned less frequently than every four hours if:

1. In storage, containers of 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 that hold ready-to-eat 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;

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 time/temperature control for safety food shall be cleaned:

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. 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.

2VAC5-585-1900. 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, a contact time of at least 10 seconds for a chlorine solution specified under subdivision 1 of 2VAC5-585-1700;^P

b. A contact time of at least seven seconds for a chlorine solution of 50 mg/L (ppm) that has a pH of 10 or less and a temperature of at least 100°F (38°C) or a pH of 8.0 or less and a temperature of at least 75°F (24°C);^P

c. A contact time of at least 30 seconds for other chemical sanitizing solutions;^P or

d. 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

2VAC5-585-2100. Sampling.

A. Water from a private well shall be sampled and tested at least annually for nitrate and total coliform.^Pf

B. If nitrate, which is reported as "N" on the test results, exceeds 10 mg/L (ppm), the operator shall notify the department by the end of the day within 24 hours from when the operator is notified of the nitrate positive 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 calendar 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 within 24 hours from when the operator is notified of the E. coli positive test result.^Pf

2VAC5-585-2120. Capacity.

A. The water source and system shall be of sufficient capacity to meet the 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

2VAC5-585-2190. 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 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 outlet 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 outlet and may not be less than one inch (25 mm).^P

2VAC5-585-2230. Handwashing sinks, numbers and capacities.

A. Except as specified in subsections subsection 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.

2VAC5-585-2270. Backflow prevention device, carbonator.

A. If not provided with an air gap as specified under 2VAC5-585-2200, a double dual 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 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.

2VAC5-585-2320. Prohibiting a cross connection.

A. A person may not create a cross connection by connecting a pipe or conduit between the drinking pure water system and a nondrinking nonpotable water system or a water system of unknown quality.^P

B. The piping of a nondrinking nonpotable water system shall be durably identified so that it is readily distinguishable from piping that carries drinking pure water. ^Pf

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.

2VAC5-585-2570. 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 in accordance with the regulations promulgated pursuant to Chapter 6 (§ 32.1-163 et seq.) of Title 32.1 of the Code of Virginia or in accordance with the related local ordinance.^P

2VAC5-585-2750. Cleaning receptacles.

A. Receptacles and waste handling units for refuse, recyclables, and returnables shall be thoroughly cleaned in a way that does not contaminate food, equipment, utensils, linens, or single-service and single-use articles, and waste water shall be disposed of as specified under 2VAC5-585-2550 2VAC5-585-2540.

B. Soiled receptacles and waste handling units for refuse, recyclables, and returnables shall be cleaned at a frequency necessary to prevent them from developing a buildup of soil or becoming attractants for insects and rodents.

2VAC5-585-2790. Indoor areas; surface characteristics.

A. Except as specified in subsection B of this section, materials for indoor floor, wall, and ceiling surfaces under conditions of normal use shall be:

1. Smooth, durable, and easily cleanable for areas where food establishment operations are conducted;

2. Closely woven and easily cleanable carpet for carpeted areas; and

3. Nonabsorbent for areas subject to moisture such as food preparation areas, walk-in refrigerators, warewashing areas, toilet rooms, mobile food establishment servicing areas, and areas subject to flushing or spray cleaning methods.

B. In a temporary food establishment:

1. A floor may be concrete, if If graded to drain, a floor may be concrete, machine-laid asphalt, or dirt or gravel if it is covered with mats, removable platforms, duckboards, or other approved materials that are effectively treated to control dust and mud; and

2. Walls and ceilings may be constructed of a material that protects the interior from the weather and windblown dust and debris.

2VAC5-585-3390. Chemicals for washing, treating, storing, and processing fruits and vegetables, criteria.

A. Chemicals, including those generated on site, used to wash or peel raw, whole fruits and vegetables or used in the treatment, storage, and processing of fruits and vegetables shall meet the requirements specified in 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

2VAC5-585-3510. Public health protection.

A. The department shall apply this chapter to promote its underlying purpose, as specified in 2VAC5-585-20, of safeguarding public health and ensuring that food is safe, unadulterated, and honestly presented when offered to the consumer.

B. In enforcing the provisions of this chapter, the department shall assess existing facilities or equipment that were in use before the effective date of this 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 subdivision 6 of 2VAC5-585-3660 2VAC5-585-3750.

2VAC5-585-3520. Preventing health hazards, provision for conditions not addressed.

A. If necessary to protect against public health hazards or nuisances, the department may impose specific requirements in addition to the requirements contained in this regulation chapter that are authorized by law.

B. The department shall document the conditions that necessitate the imposition of additional requirements and the underlying public health rationale. The documentation shall be provided to the establishment operator or person in charge and a copy shall be maintained in the department's file for the food establishment.

2VAC5-585-3540. Variances, modifications and waivers.

The department may grant a variance by modifying or waiving the requirements of this regulation chapter if, in the opinion of the department, a health hazard or nuisance will not result from the variance. If a variance is granted, the department shall retain the information specified under 2VAC5-585-3541 in its records for the food establishment.

2VAC5-585-3541. Documentation of proposed variance and justification.

Before a variance from a requirement of this chapter is approved, the information that shall be provided by the person requesting the variance and retained by the food establishment and in the department's file on the food establishment includes:

1. A statement of the proposed variance of the regulation chapter requirement citing relevant regulation chapter section numbers;^Pf

2. An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant regulation chapter 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. Maintain the approved variance at the food establishment;^Pf

2. 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. 3. Maintain and provide to the department, upon request, records specified under subdivisions 4 5 and 5 6 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 the operation or process;^Pf and

d. Necessary corrective actions if there is failure at a critical control point.^Pf

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 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 time/temperature control for safety foods that are to be controlled under the HACCP plan;^Pf

3. A flow diagram or chart for each specific food or category type that identifies:

a. Each step in the process;^Pf and

b. 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. 4. The ingredients, recipes, or formulations; or recipe that delineates materials and equipment used in the preparation of each specific food or category type; and methods and procedural control measures that address the food safety concerns involved;^Pf

4. 5. A critical control points summary for each specific food category type that clearly identifies:

a. Each critical control point;^Pf

b. The significant hazards for each critical control point;^Pf

c. The critical limits for each critical control point;^Pf

c. d. The method and frequency for monitoring and controlling each critical control point by the designated food employee 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. 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 and

g. Records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed;^Pf

5. 6. Supporting documents such as:

a. Food employee and supervisory training plan and operating procedures that addresses address 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;^Pf and

6. 7. Any other information required by the department.

Article 3

(Reserved) Conditions to Operate

2VAC5-585-3655. Responsibilities of the department. (Repealed.)

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. (Repealed.)

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 timeframes 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.

2VAC5-585-3740. 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 2VAC5-585-3750, 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.

2VAC5-585-3750. 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 timeframes 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.

2VAC5-585-3800. Frequency, establishing inspection interval.

A. Except as specified in subsections B and C of this section, the department shall inspect a food establishment at least once every six months.

B. The department may increase the interval between inspections beyond six months if:

1. The food establishment is fully operating under an approved and validated HACCP plan as specified under subdivisions 1 2 and 2 3 of 2VAC5-585-3542 and 2VAC5-585-3630.;

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.; or

3. The establishment's operation involves only coffee service and other unpackaged or prepackaged food that is not time/temperature control for safety food such as carbonated beverages and snack food such as chips, nuts, popcorn, and pretzels.

C. The department shall periodically inspect a temporary food establishment that prepares, sells, or serves unpackaged time/temperature control for safety food and that:

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

2. Has inexperienced food employees.

2VAC5-585-3815. Competency of inspectors.

A. An authorized representative of the commissioner who inspects a food establishment or conducts plan review for compliance with this regulation chapter 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 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.

2VAC5-585-3860. 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 report a disease or medical condition as specified under 2VAC5-585-80 B and D;

c. Nonconformance with 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 2VAC5-585-3542;

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 5 g 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 subsections B and C 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.

C. Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the department may agree to continuing operations in the event of an extended interruption of electrical or water service if:

1. A written emergency operating plan has been approved by the department;

2. Immediate corrective action is taken to eliminate, prevent, or control any food safety risk and imminent health hazard associated with the electrical or water service interruption; and

3. The department is informed upon implementation of the written emergency operating plan.

2VAC5-585-3940. Verification and documentation of correction.

A. After observing at the time of inspection a correction of a violation 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 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.

FORMS (2VAC5-585)

Retail Inspection Report, ODF-FSP-10001 (rev. 7/2016)

Foodborne Illness Complaint Report, ODF-FSP-10003 (rev. 6/2016)

Complaint Form, ODF-FSP-10004 (rev. 6/2016)

Retail Inspection Report, ODF-FSP-10001 (rev. 7/2018)

DOCUMENTS INCORPORATED BY REFERENCE (2VAC5-585)

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

Approved Drug Products with Therapeutic Equivalence Evaluations, 39th Edition, 2019, 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

Conference for Food Protection Standards for Accreditation of Food Protection Manager Certification Programs, April 2018, Conference for Food Protection, 30 Elliott Court, Martinsville, IN 46151-1331

Grade "A" Pasteurized Milk Ordinance, 2017 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 (NSSP) Guide for the Control of Molluscan Shellfish, 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

National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish, 2017 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 18-2016 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

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