Title of Regulation: 12VAC5-421. Food Regulations (amending 12VAC5-421-10, 12VAC5-421-30, 12VAC5-421-40, 12VAC5-421-55, 12VAC5-421-60, 12VAC5-421-70, 12VAC5-421-80, 12VAC5-421-90, 12VAC5-421-100, 12VAC5-421-180, 12VAC5-421-190, 12VAC5-421-255, 12VAC5-421-260, 12VAC5-421-270, 12VAC5-421-295, 12VAC5-421-300, 12VAC5-421-310, 12VAC5-421-340, 12VAC5-421-350, 12VAC5-421-400, 12VAC5-421-410, 12VAC5-421-440, 12VAC5-421-450, 12VAC5-421-470, 12VAC5-421-540, 12VAC5-421-660, 12VAC5-421-700, 12VAC5-421-720, 12VAC5-421-725, 12VAC5-421-730, 12VAC5-421-740, 12VAC5-421-760, 12VAC5-421-830, 12VAC5-421-850, 12VAC5-421-860, 12VAC5-421-870, 12VAC5-421-900, 12VAC5-421-930, 12VAC5-421-940, 12VAC5-421-950, 12VAC5-421-1180, 12VAC5-421-1190, 12VAC5-421-1300, 12VAC5-421-1380, 12VAC5-421-1520, 12VAC5-421-1535, 12VAC5-421-1550, 12VAC5-421-1620, 12VAC5-421-1700, 12VAC5-421-1920, 12VAC5-421-2090, 12VAC5-421-2100, 12VAC5-421-2110, 12VAC5-421-2140, 12VAC5-421-2270, 12VAC5-421-2330, 12VAC5-421-2350, 12VAC5-421-2570, 12VAC5-421-2720, 12VAC5-421-2750, 12VAC5-421-3040, 12VAC5-421-3310, 12VAC5-421-3360, 12VAC5-421-3390, 12VAC5-421-3410, 12VAC5-421-3510, 12VAC5-421-3520, 12VAC5-421-3570, 12VAC5-421-3580, 12VAC5-421-3600 through 12VAC5-421-3750, 12VAC5-421-3770, 12VAC5-421-3780, 12VAC5-421-3800 through 12VAC5-421-3840, 12VAC5-421-3860 through 12VAC5-421-3950, 12VAC5-421-3970, 12VAC5-421-4020, 12VAC5-421-4040, 12VAC5-421-4050, 12VAC5-421-4060; adding 12VAC5-421-235, 12VAC5-421-2505, 12VAC5-421-3595, 12VAC5-421-3961 through 12VAC5-421-3966; repealing 12VAC5-421-3550, 12VAC5-421-3560, 12VAC5-421-3960, 12VAC5-421-4010, 12VAC5-421-4035).

Statutory Authority: §§ 35.1-11 and 35.1-14 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: May 26, 2021.

Effective Date: June 10, 2021.

Agency Contact: Julie Henderson, Director of Food and General Environmental Services, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7455, FAX (804) 864-7475, TDD (800) 828-1120, or email julie.henderson@vdh.virginia.gov.

Basis: Sections 35.1-11 and 35.1-14 of the Code of Virginia authorize and require the State Board of Health to promulgate and enforce regulations governing restaurants in accordance with the provisions of Title 35.1 of the Code of Virginia. Section 35.1-14 provides the legal basis for the promulgation and modification of this regulation when the board elects to adopt any edition of the Food and Drug Administration (FDA) Food Code, or any portion thereof. The authority to adopt the FDA Food Code is discretionary; the authority to regulate food establishments is not.

Purpose: 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 in the United States each year. This translates into one in six Virginians who become ill. The purpose of this regulation is to prevent foodborne illness by ensuring that foods prepared and served at food establishments in Virginia are safe, unadulterated, and prepared under sanitary conditions. This is accomplished by ensuring the regulation reflects current science and technology regarding minimum sanitary standards for food establishments to protect the dining public. These standards include approved sources for foods used in food establishments; specifications for safe handling, storage, preparation, and serving of food; personal hygiene of employees; precautions to prevent the transmission of diseases communicable through food; and the general sanitation of the facility. When followed, these minimum standards protect the public health, safety, and welfare. In addition, amending the Food Regulations to conform to the 2017 FDA Food Code will ensure the regulation promotes uniformity in administration of the food safety program. The benefits of adopting and implementing uniform standards have shown to lead to higher compliance, consistent training of public health staff, and an increased shared responsibility of the food industry and the government in ensuring food provided to the consumer is safe and does not become a vehicle for a disease outbreak or for the transmission of communicable disease.

Rationale for Using Fast-Track Rulemaking Process: The Virginia Department of Health is initiating this regulatory action to amend its regulations to comport the Food Regulations with the current FDA Food Code and to ensure clarity and uniform application. The FDA Food Code, revised approximately every four years, serves as a model document to assist state and local agencies with regulatory authority over food safety by creating a regulatory scheme that reflects the most current science available to reduce the risk of food borne illnesses associated with food establishments. VDH has revised the Food Regulations to reflect updates to the FDA Food Code, which include updates to effective controls as a means to reduce the risk of foodborne illness that contribute to financial losses and have dire health consequences. This regulatory action is best suited for the fast-track rulemaking process as it is expected to be noncontroversial. The proposed changes ensure the Food Regulations reflect changes made to the 2017 FDA Food Code, complement current Virginia law, and provide minimal burdens on regulants while protecting public health.

Substance: The proposed changes to the Food Regulations revise the regulations to incorporate the 2017 FDA Food Code and the 2017 FDA Food Code Annex I, in part. The proposed changes also ensure that the regulations complement current Virginia law and provide minimal burdens on regulants while protecting public health. Substantive changes include (i) the removal, addition, and revision of definitions; (ii) language amended to require the person in charge to be a certified food protection manager, (iii) language added to include standards for the use of bandages, finger cots, or finger stalls, (iv) language added to require written procedures for the clean-up of vomiting and diarrheal events, (v) language added to require the separation of raw animal foods from fruits and vegetables in certain instances, (vi) language amended to reflect new cooking time for raw animal foods, (vii) the removal of the Food Service Advisory Committee to reflect changes within the Food and Drug Administration, and (viii) language added to provide clarity to enforcement procedures when impounding food.

Issues: The primary advantage of the regulation to the public is the establishment of modern science-based standards that support the prevention of foodborne illness risk factors and ensure the safety of food service within the Commonwealth. The revisions will also make the regulation more understandable and align them with best practices. The primary advantage to the agency is that the regulation will be based on current food science and clarify ambiguous areas relating to enforcement and inspection standards. Staff who better understand the regulatory scheme of food safety provide enhanced communication to the public and regulant community on how to prevent food borne illness. The primary advantage to the regulated community, particularly chains and franchises that operate in other states as well as in multiple jurisdictions across the Commonwealth that have adopted the current version of the FDA Food Code, will be more consistent regulatory application. There are no known disadvantages to the public or the Commonwealth with the adoption of this regulation.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health proposes numerous amendments to 12VAC5-421 Food Regulations, many of which conform to the latest U.S. Food and Drug Administration (FDA) model regulations.

Background. 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

The following proposed amendments to the regulation conform to requirements in the 2017 FDA Food Code:

• Require that that there be a certified food protection manager (CFPM) on the premises of the food establishment³ at all times of operation.
• 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 the Virginia Department of Health (VDH).
• Require that food establishments notify customers that a copy of the most recent establishment inspection report is available upon request by either: a) posting a sign or placard in a location in the food establishment that is conspicuous to customers, or b) by another method acceptable to the department.

When inspectors find violations of any of the regulations 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 change times in which violations of requirements must be corrected as follows:

Core to Priority (90 calendar days to 72 hours):

• When a food employee is excluded from the food establishment as required due to being diagnosed with an infection from Salmonella (nontyphoidal), the exclusion for the food employee who is symptomatic should be retained until either of the following are met: a) the excluded food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Salmonella (nontyphoidal) infection based on test results showing two consecutive negative stool specimen cultures that are taken, or b) the food employee was restricted after symptoms of vomiting or diarrhea are resolved, and more than 30 days have passed since the food employee became asymptomatic.
• In a food establishment that serves a highly susceptible population,⁶ unpackaged juice that is prepared on the premises for service or sale in a ready-to-eat form must be processed under a Hazard Analysis and Critical Control Point (HACCP) plan⁷ and as specified in 21 CFR 120.24.

Priority Foundation to Priority (10 calendar days to 72 hours):

• Food must be safe, unadulterated, and honestly presented.⁸
• Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory must, if individually cut in a food establishment, be cut from whole-muscle intact beef that is labeled by a food processing plant.

Core to Priority Foundation (90 calendar days to 10 calendar days):

• In manual warewashing⁹ operations, a temperature measuring device must be provided and readily accessible for frequently measuring the washing and sanitizing temperatures.
• In hot water mechanical warewashing operations, an irreversible registering temperature indicator must be provided and readily accessible for measuring the utensil surface temperature.
• Water from a private well must be sampled and tested at least annually for nitrate and total coliform.
• For a food establishment that is required to have a HACCP plan, the HACCP plan must include general information such as the name of the permit applicant or permit holder, the food establishment address, and contact information.

Priority to Priority Foundation (72 hours to 10 calendar days):

• If time without temperature control is used as the public health control up to a maximum of four hours, the food must 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;
• If time without temperature control is used as the public health control up to a maximum of six hours, the food shall be monitored to ensure the warmest portion of the food does not exceed 70ºF (21ºC) during the six-hour period, unless an ambient air temperature is maintained that ensures the food does not exceed 70ºF (21ºC) during the six-hour holding period.

Other Proposed Changes

The following proposed amendments to the regulation are not related to the 2017 FDA Food Code:

• Specify that shucked shellfish from one tagged or labeled container are not commingled with shellstock¹⁰ 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.
• Specify that records demonstrating inspection and service of water treatment devices and backflow preventers be maintained by the person in charge for a minimum of five years.
• Require that any food establishment permit applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan.
• Require that existing food establishments notify VDH in writing of a change of legal ownership or when business operations have terminated. Such notice must be submitted, in writing, to VDH at least 30 days prior to the legal ownership transfer or termination of business operation.
• Eliminate the option for Bed & Breakfast operations to have a food establishment permit.

Estimated Benefits and Costs

Conforming to 2017 FDA Food Code

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, and 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 do not have one person who works 100 percent of open hours, most would need to get one or more additional employees certified.

Under both the existing and proposed regulations, proficiency as a certified food protection manager is established through passing a test, not completing a program. According to VDH, certification costs (for the test) range from $28 to $100 per individual and requires renewal 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 where the training time various from self-pace to approximately sixteen hours. Training and tests are available both online and in person.¹¹ The total cost of requiring that a CFPM be onsite at all times of operation would 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. If say a CFPM candidate spends eight hours preparing for the test and two hours taking the test, there is the cost of ten hours of staff time that has to be covered by another employee. Having a CFPM always present in the open operation who is knowledgeable on food protection as guaranteed through certification, would likely reduce 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 requires 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).¹²

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 are written. This would help ensure that those procedures are consistent, regardless of whoever is in charge at a given time. VDH has a template that it can make 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: a) requiring the protection of 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,¹³ would increase food safety. For any food establishments that do not already separate prewashed fruits and vegetables from raw animal foods during storage, preparation holding and display, 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,¹⁴ 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 owner must notify VDH. If a sample is total coliform positive, the positive culture medium must be further analyzed to determine if E. coli is present. The owner must notify VDH within two days from when the owner is notified of the coliform positive test result. If E. coli is present, the owner must notify VDH. 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 VDH to take faster action regarding a potential health threat.

The Board proposes to require that food establishments notify customers that a copy of the most recent establishment inspection report is available upon request by either: a) posting a sign or placard in a location in the food establishment that is conspicuous to customers, or b) by another method acceptable to department. According to VDH, the food establishment would not need to have the report on hand. The customers could be referred to VDHs online portal that publicly displays the reports, as well as the local health department. Thus, there would only be the minimal cost of posting the sign or placard.

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 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. 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 served to patrons.

The current regulation states that records demonstrating inspection and service of water treatment devices and backflow preventers be maintained by the person in charge. The Board proposes to specify that the records be maintained for a minimum of five years. Since the current language implies that the records must be kept indefinitely, the proposal for a five-year minimum reduces the burden in that the records could be disposed of after five years.

The Board proposes to state that any food establishment permit applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan. This is valuable for the department in that relevant information that was already submitted might have changed such that the application would no longer be appropriate for approval. The applicant would have to pay an additional $40 application fee, and if a new plan review is deemed necessary, an additional $40 plan review fee. The applicant would also incur the time needed to produce the new application and plan.

The current regulation does not specify that existing food establishments notify VDH in writing of a change of legal ownership or when business operations have terminated. The Board proposes to specify that such notice be submitted, in writing, to VDH at least 30 days prior to the legal ownership transfer or termination of business operation. To the extent that it is followed, this proposal would help the department maintain contact with those actually serving food to the public and help ensure food safety.

Bed & Breakfasts are not required to have a food establishment permit. Under the current regulation these businesses may optionally apply for such a permit, which does not provide them with any privileges that they would not possess without the permit. It is likely that the permit is used for marketing purposes.¹⁵ The Board proposes to eliminate the option for Bed & Breakfasts to have a food establishment permit. This would not prevent any Bed & Breakfast from operating, but to the extent that the permit helped garner demand for some, it may reduce revenue. According to VDH, allowing voluntary permitting has created issues for its staff when these facilities are found in violation and then elect to deregulate to avoid corrections.

Businesses and Other Entities Affected. The proposed amendments affect the approximate 38,000 food establishments in the Commonwealth, the six accredited CFPM programs, and Bed & Breakfasts¹⁶ that have or might wish to have a food establishment permit. 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 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 increase costs for most food establishments. The proposal to state that any food establishment permit applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan would increase cost for applicants in such a situation. The proposal to eliminate the option for Bed & Breakfasts to have a food establishment permit may reduce revenue for those Bed & Breakfasts that have had a permit.

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 Businesses¹⁷ Affected:

Types and Estimated Number of Small Businesses Affected. VDH estimates that 95% to 100% of the approximate 38,000 food establishments 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 are 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.

Localities¹⁸ Affected¹⁹. The proposed amendments 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 increase costs for most food establishments. The proposal to state that any food establishment permit applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan would increase cost for applicants in such a situation. The proposal to eliminate the option for Bed & Breakfasts to have a food establishment permit may reduce revenue for those Bed & Breakfasts that have had a permit. These cost increases and potential revenue reduction would likely moderately reduce the value of affected firms commensurately.

The proposal to specify that records demonstrating inspection and service of water treatment devices and backflow preventers must only be maintained for five years would moderately reduce recordkeeping costs, producing a potential small commensurate increase in firm value. 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"Food establishment" is defined as "an operation that (i) stores, prepares, packages, serves, or vends food directly to the consumer, or otherwise provides food to the public for human consumption, such as a 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, market, vending location, conveyance used to transport people, institution, or food bank, and (ii) relinquishes possession of 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."

⁴See 12VAC5-421-700 A 2 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14169&replace=yes

⁵See 12VAC5-421-700 A 3 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14169&replace=yes

⁶"Highly susceptible population" is defined as "persons who are more likely than other people in the general population to experience foodborne disease because they are: 1. immunocompromised, preschool age children, or older adults; and 2. 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."

⁷"Hazard Analysis and Critical Control Point plan" is defined as "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."

⁸Pursuant to 12VAC5-421-890, honestly presented is: a) food shall be offered for human consumption in a way that does not mislead or misinform the consumer, and b) food or color additives, colored overwraps, or lights shall not be used to misrepresent the true appearance, color, or quality of a food.

⁹"Warewashing" is defined as "the cleaning and sanitizing of utensils and food-contact surfaces of equipment."

¹⁰"Shellstock" is defined as "raw, in-shell molluscan shellfish."

¹¹Data and other information source: VDH

¹²Source: Amazon.com accessed on March 13, 2020.

¹³See 12VAC5-421-700 A 2 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14169&replace=yes

¹⁴See 12VAC5-421-700.A 3 for affected raw animal foods. https://townhall.virginia.gov/l/viewXML.cfm?textid=14169&replace=yes

¹⁵VDH does not have data on the number of Bed & Breakfasts with permits.

¹⁶Ibid

¹⁷Pursuant 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."

¹⁸"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.

¹⁹§2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

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

Summary:

The amendments comport (12VAC5-421) Food Regulations with the current 2017 Food and Drug Administration (FDA) Food Code and the Supplement to the 2017 FDA Food Code Annex I, increase clarity, and ensure uniform application. The FDA Food Code, revised approximately every four years, serves as a model document to assist state and local agencies with regulatory authority over food safety by creating a regulatory scheme that reflects the most current science available to reduce the risk of food borne illnesses associated with food establishments. Changes to the FDA Food Code reflected in the amendments to 12VAC5-421 include updates to effective controls as a means to reduce the risk of foodborne illness that contribute to financial losses and have dire health consequences. Substantive changes include (i) the removal, addition, and revision of definitions; (ii) a requirement that the person in charge be a certified food protection manager; (iii) standards for the use of bandages, finger cots, or finger stalls; (vi) written procedures requirements for the clean-up of vomiting and diarrheal events; (v) requirements for the separation of raw animal foods from fruits and vegetables in certain instances; (vi) new cooking time requirements for raw animal foods; (vii) removal of the Food Service Advisory Committee to reflect changes within the Food and Drug Administration; and (viii) clarifying enforcement procedures when impounding food.

12VAC5-421-10. Definitions.

A. Section 35.1-1 of the Code of Virginia provides definitions of the following terms and phrases as used in this chapter.

"Board"

"Commissioner"

"Department"

B. For the purposes of implementing this chapter, the term "food establishment" as defined herein is equivalent to the term "restaurant" as defined in 35.1-1 of the Code of Virginia.

C. 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 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, § 201(s) and 21 CFR 170.3(e)(1) or (ii) "color additive" having the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 201(t) and 21 CFR 70.3(f).

"Adulterated" has the meaning stated in the Federal Food, Drug, and Cosmetic Act, § 402.

"Agent" means a legally authorized representative of the owner.

"Agent of the commissioner" means the district or local health director, unless otherwise stipulated.

"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, Waterworks Regulations; or a private well constructed, maintained, and operated pursuant to 12VAC5-630, Private Well Regulations.

"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.

"Bed and breakfast operation" means a residential-type establishment that provides (i) two or more rental accommodations for transient guests and food service to a maximum of 18 transient guests on any single day for five or more days in any calendar year or (ii) at least one rental accommodation for transient guests and food service to a maximum of 18 transient guests on any single day for 30 or more days in any calendar year.

"Beverage" means a liquid for drinking, including water.

"Board" means the State Board of Health.

"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.

"Building official" means a representative of the Department of Housing and Community Development.

"Casing" means a tubular container for sausage products made of either natural or artificial (synthetic) material.

"Catering operation" means a person who contracts with a client to prepare a specific menu and amount of food in an approved and a permitted food establishment for service to the client's guests or customers at a service location different from the permitted food establishment. Catering may also include cooking or performing final preparation of food at the service location.

"Catering operation" does not include:

1. A private chef or cook who, as the employee of a consumer, prepares food solely in the consumer's home.

2. Delivery service of food by an approved and permitted food establishment to an end consumer.

"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 number, such as 40 CFR 180.194 refers to Title 40, Part 180, Section 194.

"Clean in Place" or "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 "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.

"Commissary" means a catering establishment, food establishment, or any other place in which food, food containers, or supplies are kept, handled, prepared, packaged, or stored for distribution to satellite operations.

"Commissioner" means the State Health Commissioner, his duly designated officer, or his agent.

"Commonwealth" means the Commonwealth of Virginia.

"Conditional employee" means a potential food employee to whom a job offer is made with employment dependent upon, conditional on responses to subsequent medical questions or examinations designed to identify potential food employees who may be suffering from a disease that can be transmitted through food and done in compliance with Title 1 of the Americans with Disabilities Act of 1990.

"Confirmed disease outbreak" means a foodborne disease outbreak in which laboratory analysis of appropriate specimens identifies a causative organism or chemical agent and epidemiological analysis implicates the food as the source of the illness.

"Consumer" means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food establishment or food processing plant, and does not offer the food for resale.

"Core item" means a provision in this chapter that is not designated as a priority item or a priority foundation item. Core item includes an item that usually relates to general sanitation, operational controls, sanitation standard operating procedures (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 and is listed in the U.S. Food and Drug Administration's Interstate Certified Shellfish Shippers List, updated monthly (U.S. Food and Drug Administration).

"Delicatessen" means a store where ready to eat products such as cooked meats, prepared salads, etc. are sold for off-premises consumption.

"Department" means the Virginia Department of Health.

"Director" means the district or local health director.

"Disclosure" means a written statement that clearly identifies the animal derived foods that are, or can be ordered, raw, undercooked, or without otherwise being processed to eliminate pathogens in their entirety, or items that contain an ingredient that is raw, undercooked, or without otherwise being processed to eliminate pathogens.

"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, ratite, 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 permit holder, 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. "Equipment" includes items such as a freezer, grinder, hood, ice maker, meat block, mixer, oven, reach-in refrigerator, scale, sink, slicer, stove, table, temperature measuring device for ambient air, vending machine, or warewashing machine. Equipment does not include 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.

"°F" means degrees Fahrenheit.

"FDA" means the U.S. Food and Drug Administration.

"Fish" means fresh or saltwater finfish, crustaceans, and other forms of aquatic life (including alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, 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, or vends food directly to the consumer, or otherwise provides food to the public for human consumption, such as a 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, market, vending location, conveyance used to transport people, institution, or food bank, and (ii) relinquishes possession of 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 feeding location is permitted under this chapter; 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 and regardless of whether there is a charge for the food; and (iii) a facility that does not meet the exemption criteria identified in subdivision 6 of this definition or a facility that meets the exemption requirements but chooses to be regulated under this chapter.

For the purpose of implementing this chapter, the following places are also included in the definition of a "food establishment" as defined in § 35.1-1 of the Code of Virginia:

1. Any place where food is prepared for service to the public on or off the premises, or any place where food is served, including lunchrooms, short order places, cafeterias, coffee shops, cafes, taverns, delicatessens, dining accommodations of public or private clubs, kitchen facilities of hospitals and nursing homes, dining accommodations of public and private schools and colleges, and kitchen areas of local correctional facilities subject to standards adopted under § 53.1-68 of the Code of Virginia.

2. Any place or operation that prepares or stores food for distribution to persons of the same business operation or of a related business operation for service to the public, including operations preparing or storing food for catering services, push cart operations, hotdog stands, and other mobile points of service.

3. Mobile points of service to which food is distributed by a place or operation described in subdivision 2 of this definition, unless the point of service and of consumption is in a private residence.

"Food establishment" does not include:

1. An establishment that offers only prepackaged food that is not time/temperature control for safety food;

2. A produce stand that only offers whole, uncut fresh fruits and vegetables; or

3. A food processing plant, including those that are located on the premises of a food establishment;.

4. A kitchen in a private home if only food that is not time/temperature control for safety food is prepared for sale or service at a function such as a religious or charitable organization's bake sale if allowed by law and if the consumer is informed by a clearly visible placard at the sales or service location that the food is prepared in a kitchen that is not subject to regulation and inspection by the regulatory authority;

5. An area where food that is prepared as specified in subdivision 4 of this definition is sold or offered for human consumption;

6. A kitchen in a private home, such as, but not limited to, a family day-care provider or a home for adults, serving 12 or fewer recipients;

7. A private home that receives catered or home-delivered food; or

8. Places manufacturing packaged or canned foods that are distributed to grocery stores or other similar food retailers for sale to the public.

For the purpose of implementing this chapter, the following are also exempt from the definition of a "food establishment" in this chapter, as defined in §§ 35.1-25 and 35.1-26 of the Code of Virginia:

1. Boarding houses that do not accommodate transients;

2. Cafeterias operated by industrial plants for employees only;

3. Churches, fraternal, school and social organizations and volunteer fire departments and rescue squads that hold dinners and bazaars not more than one time per week and not in excess of two days duration at which food prepared in homes of members or in the kitchen of the church or organization and is offered for sale to the public;

4. Grocery stores, including the delicatessen that is a part of a grocery store, selling exclusively for off-premises consumption and places manufacturing or selling packaged or canned goods;

5. Churches that serve meals for their members as a regular part of their religious observance;

6. Convenience stores or gas stations that are subject to the State Board of Agriculture and Consumer Services' Retail Food Establishment Regulations (2VAC5-585) or any regulations subsequently adopted and that (i) have 15 or fewer seats at which food is served to the public on the premises of the convenience store or gas station and (ii) are not associated with a national or regional restaurant chain. Notwithstanding this exemption, such convenience stores or gas stations shall remain responsible for collecting any applicable local meals tax; and

7. Any bed and breakfast operation that prepares food for and offers food to guests, regardless of the time the food is prepared and offered, if (i) the premises of the bed and breakfast operation is a home that is owner occupied or owner-agent occupied, (ii) the bed and breakfast operation prepares food for and offers food to transient guests of the bed and breakfast only, (iii) the number of guests served by the bed and breakfast operation does not exceed 18 on any single day, and (iv) guests for whom food is prepared and to whom food is offered are informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the food is prepared in a kitchen that is not licensed as a restaurant and is not subject to the regulations governing restaurants.

"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.

"Game animal" includes mammals such as reindeer, elk, deer, antelope, water buffalo, bison, rabbit, squirrel, opossum, raccoon, nutria, or muskrat and nonaquatic reptiles such as land snakes.

"Game animal" does not include ratites such as ostrich, emu, and rhea.

"General use pesticide" means a pesticide that is not classified by EPA for restricted use as specified in 40 CFR 152.175.

"Grade A standards" means the requirements of the 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 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.

"Hazard Analysis and Critical Control Point" or "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.

"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:

1. Immunocompromised, preschool age children, or older adults; and

2. 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 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, injection, 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 any highly refined oil derived from a major food allergen in this definition and any ingredient derived from such highly refined oil or 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 12VAC5-421-330 A 2 and A 3.

"Mechanically tenderized" means manipulating meat with deep penetration by processes which may be referred to as "blade tenderizing," "jaccarding," "pinning," "needling," or using blades, pins, needles, or any mechanical device. "Mechanically tenderized" does not include processes by which solutions are injected into meat.

"mg/L" means milligrams per liter, which is the metric equivalent of parts per million (ppm).

"Mobile food unit" means a food establishment mounted on wheels (excluding boats in the water) readily moveable from place to place at all times during operation and shall include pushcarts, trailers, trucks, or vans. The unit, all operations, and all equipment must be integral to and be within or attached to the unit.

"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.

"Occasional" means not more than one time per week, and not in excess of two days duration.

"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.

"Permit" means a license issued by the regulatory authority department that authorizes a person to operate a food establishment.

"Permit holder" means the entity person that is legally responsible for the operation of the food establishment such as the owner, the owner's agent, or other person, and possesses a valid permit to operate a food establishment.

"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 7 indicate acidity and values between 7.0 7 and 14 indicate alkalinity. The value for pure distilled water is 7.0 7, 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, that include cleaning and sanitizing agents and agents such as caustics, acids, drying agents, polishes, and other chemicals;

2. Pesticides, except sanitizers, that include substances such as insecticides and rodenticides;

3. Substances necessary for the operation and maintenance of the establishment such as nonfood grade lubricants, paints, and personal care items that may be deleterious to health; and

4. Substances that are not necessary for the operation and maintenance of the establishment and are on the premises for retail sale, such as petroleum products and paints.

"Potable water" means water fit for human consumption that is obtained from an approved water supply and that is (i) sanitary and normally free of minerals, organic substances, and toxic agents in excess of reasonable amounts and (ii) adequate in quantity and quality for the minimum health requirements of the persons served (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia). 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 permit holder; or the physical facility, its contents, and the land or property which are under the control of the permit holder and may impact food establishment personnel, facilities, or operations, if a food establishment is only one component of a larger operation such as a health care facility, hotel, motel, school, recreational camp, or prison.

"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 record keeping, and labeling and is denoted in this regulation with a superscript Pf-^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-^p.

"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 (see §§ 32.1-167 and 32.1-176.1 of the Code of Virginia and 12VAC5-590, Waterworks Regulations and 12VAC5-630-370). 12VAC5-630, Private Well Regulations. Potable water is traditionally known as drinking water, and excludes such nonpotable forms as "boiler water," "mop water," "rainwater," "wastewater," and "nondrinking water."

"Pushcart" means any wheeled vehicle or device other than a motor vehicle or trailer that may be moved with or without the assistance of a motor and that does not require registration by the department of motor vehicles.

"Ratite" means a flightless bird such as an emu, ostrich, or rhea.

"Ready-to-eat food" means food that:

1. Is in a form that is edible without additional preparation to achieve food safety, as specified under 12VAC5-421-700 A, B, and C, 12VAC5-421-710 or 12VAC5-421-730;

2. Is a raw or partially cooked animal food and the consumer is advised as specified under 12VAC5-421- 700 D 1 and 3; or

3. Is prepared in accordance with a variance that is granted as specified under 12VAC5-421-700 D 4.

Ready-to-eat food "Ready-to-eat food" 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 12VAC5-421-700, or 12VAC5-421-710 or frozen as specified under 12VAC5-421-730;

2. Raw fruits and vegetables that are washed as specified under 12VAC5-421-510;

3. Fruits and vegetables that are cooked for hot holding as specified under 12VAC5-421-720;

4. All time/temperature control for safety food that is cooked to the temperature and time required for the specific food under 12VAC5-421-700 Article 4 (12VAC5-421-700 et seq.) of Part III and cooled as specified in 12VAC5-421-800;

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 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 a process as specified in 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 psychrotrophic 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 psychrotrophic psychotropic pathogens.

"Refuse" means solid waste not carried by water through the a sewage system.

"Regulatory authority" means the Virginia Department of Agriculture and Consumer Services, the Virginia Department of Health or their authorized representative having jurisdiction over the food establishment. local, state, or federal enforcement body or 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" "Re-service" means the transfer of food that is unused and returned by a consumer after being served or sold and in the possession of the consumer, to another person.

"Restrict" means to limit the activities of a food employee so that there is no risk of transmitting a disease that is transmissible through food and the food employee does not work with exposed food, clean equipment, utensils, linens, and or unwrapped single-service or single-use articles.

"Restricted egg" means any check, dirty egg, incubator reject, inedible, leaker, or loss as defined in 9 CFR Part 590.

"Restricted use pesticide" means a pesticide product that contains the active ingredients specified in 40 CFR 152.175 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 shall 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 FDA.

"Sanitization" means the application of cumulative heat or chemicals on cleaned food-contact surfaces that, when evaluated for efficacy, is sufficient to yield a reduction of five logs, which is equal to a 99.999% reduction, of representative disease microorganisms of public health importance.

"Sealed" means free of cracks or other openings that permit allow the entry or passage of moisture.

"Service animal" means an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.

"Servicing area" means an operating base location to which a mobile food establishment or transportation vehicle returns regularly for such things as vehicle and equipment cleaning, discharging liquid or solid wastes, refilling water tanks and ice bins, and boarding food.

"Sewage" means liquid waste containing animal or vegetable matter in suspension or solution and may include liquids containing chemicals in solution. 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 such as the Virginia Department of Health Division of Shellfish Sanitation.

"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 0157:H7, E. coli 0157:NM, E. coli 026:H11; E. coli 0145NM E. Coli 0145:NM, E. coli 0103:H2, and E. coli 0111: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 which that do not meet the materials, durability, strength, and cleanability specifications contained in 12VAC5-421-960, 12VAC5-421-1080, and 12VAC5-421-1100 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 non-food-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.

"Substantial compliance" means equipment or structure design or construction; food preparation, handling, storage, transportation; or cleaning procedures that will not substantially affect health consideration or performance of the facility or the employees.

"Tableware" means eating, drinking, and serving utensils for table use such as flatware including forks, knives, and spoons; hollowware including bowls, cups, serving dishes, 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 food" means a food that requires time/temperature control for safety to limit pathogenic microorganism growth or toxin formation:

1. TCS 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 food 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 food means time/temperature control for safety food **PA means product assessment required

2. TCS 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 regulatory authority department that authorizes a modification or waiver of one or more requirements of this chapter if, in the opinion of the regulatory authority 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, electronic transaction, or by optional manual operation, dispenses unit servings of food in bulk or in packages without the necessity of replenishing the device between each vending operation.

"Vending machine location" means the room, enclosure, space, or area where one or more vending machines are installed and operated and includes the storage 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 (see Article 2 (§ 32.1-167 et seq.) of Chapter 6 of Title 32.1 of the Code of Virginia).

"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.

12VAC5-421-30. Purpose.

This chapter has been promulgated by the State Board of Health board to specify the following requirements to protect public health:

1. A procedure for obtaining a license (permit);

2. Criteria for assuring the safe preparation, handling, protection and/or temperature control for food;

3. Criteria for the safe and sanitary maintenance, storage, operation and use of equipment;

4. Requirements that food establishments be connected to, and use utilize an approved water supply and sewage disposal system;

5. Requirements for toilet and cleansing facilities for employees and customers;

6. Criteria for vector and pest control;

7. Requirements for the sanitary maintenance and use of food establishment's physical plant;

8. Requirements for appropriate lighting and ventilation not otherwise provided for in the Uniform Statewide Building Code; and

9. A classification system for food establishments.

12VAC5-421-40. Administration of regulation.

This chapter is administered by the following:

1. The State Board of Health, hereinafter referred to as the board, board has responsibility to promulgate, amend and repeal regulations necessary to protect the public health.

2. The State Health Commissioner, hereinafter referred to as the commissioner, commissioner is the chief executive officer of the State Department of Health department. The commissioner has the authority to act within the scope of regulations promulgated by the board and for the board when it is not in session.

3. The district or local health director, hereinafter referred to as the director, is responsible for the permitting and inspection of food establishments located within the director's district and for assuring compliance with this part chapter. The director is the duly designated officer or agent of the commissioner.

12VAC5-421-55. Certified food protection manager.

A. At least one employee with supervisory and management responsibility and the authority to direct and control food preparation and service The person in charge shall be a certified food protection manager, demonstrating who has shown proficiency of required knowledge and information through passing a test that is part of an accredited program.

B. This section does not apply to food establishments that serve only non-temperature non-time/temperature control for safety food and food establishments where food handling does not exceed reheating, cold holding, and hot holding of commercially processed and packaged ready-to-eat foods that store and prepare food only to the extent that they reheat or cold hold commercially processed, fully cooked time/temperature control for safety foods. Food establishments exempt from the certified food protection manager requirement may not cool time/temperature control for safety foods.

C. For purposes of enforcement, this section will take effect on July 1, 2018 June 10, 2023.

12VAC5-421-60. Demonstration of knowledge.

Based on the risks of foodborne illness inherent to the food operation, during inspections and upon request the person in charge shall demonstrate to the regulatory authority department knowledge of foodborne disease prevention, and the requirements of this chapter. The person in charge shall demonstrate this knowledge by:

1. Complying with this chapter by having no violations of priority items during the current inspection;^Pf

2. Being a certified food protection manager who has shown proficiency of required information through passing a test that is part of an accredited program;^Pf or

3. Responding correctly to the environmental health specialist's questions as they relate to the specific food operation. The areas of operation may include:

a. Describing the relationship between the prevention of foodborne disease and the personal hygiene of a food employee;^Pf

b. Explaining the responsibility of the person in charge for preventing the transmission of foodborne disease by a food employee who has a disease or medical condition that may cause foodborne disease;^Pf

c. Describing the symptoms associated with the diseases that are transmissible through food;^Pf

d. Explaining the significance of the relationship between maintaining the time and temperature of time/temperature control for safety food and the prevention of foodborne illness;^Pf

e. Explaining the hazards involved in the consumption of raw or undercooked meat, poultry, eggs, and fish;^Pf

f. Stating the required food temperatures and times for safe cooking of time/temperature control for safety food including meat, poultry, eggs, and fish;^Pf

g. Stating the required temperatures and times for the safe refrigerated storage, hot holding, cooling, and reheating of time/temperature control for safety food;^Pf

h. Describing the relationship between the prevention of foodborne illness and the management and control of the following:

(1) Cross contamination,;^Pf

(2) Hand contact with ready-to-eat foods,;^Pf

(3) Handwashing,;^Pf and

(4) Maintaining the food establishment in a clean condition and in good repair;^Pf

i. Describing the foods identified as major food allergens and the symptoms that a major food allergen could cause in a sensitive individual who has an allergic reaction;^Pf

j. Explaining the relationship between food safety and providing equipment that is:

(1) Sufficient in number and capacity,;^Pf and

(2) Properly designed, constructed, located, installed, operated, maintained, and cleaned;^Pf

k. Explaining correct procedures for cleaning and sanitizing utensils and food-contact surfaces of equipment;^Pf

l. Identifying the source of water used and measures taken to ensure that the water supply remains protected from contamination such as providing protection from backflow and precluding the creation of cross connections;^Pf

m. Identifying poisonous or toxic materials in the food establishment and the procedures necessary to ensure that they are safely stored, dispensed, used, and disposed of according to law;^Pf

n. Identifying critical control points in the operation from purchasing through sale or service that when not controlled may contribute to the transmission of foodborne illness and explaining steps taken to ensure that the points are controlled in accordance with the requirements of this chapter;^Pf

o. Explaining the details of how the person in charge and food employees comply with a HACCP plan if such a plan is required by the law, this chapter, or a voluntary an agreement between the regulatory authority department and the food establishment; ^Pf

p. Explaining the responsibilities, rights, and authorities assigned by this chapter to the:

(1) Food employee,;^Pf

(2) Conditional employee,;^Pf

(3) Person in charge,;^Pf and

(4) Regulatory authority Department;^Pf and

q. Explaining how the person in charge, food employees, and conditional employees comply with reporting responsibilities and the exclusion or restriction of food employees.^Pf

12VAC5-421-70. Duties of person in charge.

The person in charge shall ensure that:

1. Food establishment operations are not conducted in a private home or in a room used as living or sleeping quarters as specified under 12VAC5-421-2990;^Pf

2. Persons unnecessary to the food establishment operation are not allowed in the food preparation, food storage, or warewashing areas, except that brief visits and tours may be authorized by the person in charge if steps are taken to ensure that exposed food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles are protected from contamination;^Pf

3. Employees and other persons such as delivery and maintenance persons and pesticide applicators entering the food preparation, food storage, and warewashing areas comply with this chapter;^Pf

4. Employees are effectively cleaning their hands, by routinely monitoring the employees' handwashing;^Pf

5. Employees are visibly observing foods as they are received to determine that they are from approved sources, delivered at the required temperatures, protected from contamination, unadulterated, and accurately presented, by routinely monitoring the employees' observations and periodically evaluating foods upon their receipt;^Pf

6. Employees are verifying that foods delivered to the food establishment during non-operating hours are from approved sources and are placed into appropriate storage locations such that they are maintained at the required temperatures, protected from contamination, unadulterated, and accurately presented;^Pf

7. Employees are properly cooking time/temperature control for safety food, being particularly careful in cooking those foods known to cause severe foodborne illness and death, such as eggs and comminuted meats, through daily oversight of the employees' routine monitoring of the cooking temperatures using appropriate temperature measuring devices properly scaled and calibrated as specified under 12VAC5-421-1180 and 12VAC5-421-1730 B;^Pf

8. Employees are using proper methods to rapidly cool time/temperature control for safety food that is not held hot or is not for consumption within four hours, through daily oversight of the employees' routine monitoring of food temperatures during cooling;^Pf

9. Employees are properly maintaining the temperatures of time/temperature control for safety food during hot and cold holding through daily oversight of the employees routine monitoring of food temperatures;^Pf

10. Consumers who order raw or partially cooked ready-to-eat foods of animal origin are informed as specified under 12VAC5-421-930 that the food is not cooked sufficiently to ensure its safety;^Pf

11. Employees are properly sanitizing cleaned multiuse equipment and utensils before they are reused, through routine monitoring of solution temperature and exposure time for hot water sanitizing, and chemical concentration, pH, temperature, and exposure time for chemical sanitizing;^Pf

12. Consumers are notified that clean tableware is to be used when they return to self-service areas such as salad bars and buffets as specified in 12VAC5-421-590;^Pf

13. Except when approval is obtained from the regulatory authority department as specified in 12VAC5-421-450 E, employees are preventing cross-contamination of ready-to-eat food with bare hands by properly using suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment; ^Pf

14. Employees are properly trained in food safety, including food allergy awareness, as it relates to their assigned duties;^Pf

15. Food employees and conditional employees are informed in a verifiable manner of their responsibility to report in accordance with law, to the person in charge, information about their health and activities as they relate to diseases that are transmissible through food, as specified under 12VAC5-421-80;^Pf and

16. Written procedures and plans, where specified by this chapter and as developed by the food establishment, are maintained and implemented as required.^Pf

12VAC5-421-80. Responsibility of permit holder, person in charge, and conditional employees.

A. The permit holder 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 Typhoid fever, diagnosed by a health practitioner, within the past three months, 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 (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 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, and 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 regulatory authority department when a food employee is:

1. Jaundiced;^Pf or

2. Diagnosed with an illness due to a pathogen as specified under subdivisions A 2 a through 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, 2, and 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 12VAC5-421-100;^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 12VAC5-421-100.^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 history of exposure as specified under subdivisions A 1 through 5 of this section is:

1. Excluded as specified under subdivisions 1, 2, and 3 of 12VAC5-421-90, and subdivisions 4 a, 5 a, 6 a, 7, or 8 a of 12VAC5-421-90 and in compliance with the provisions specified under subdivisions 1 through 8 of 12VAC5-421-100;^P or

2. Restricted as specified under subdivision 4 b, 5 b, 6 b, or 8 b of 12VAC5-421-90, or subdivision 9 or 10 of 12VAC5-421-90 and in compliance with the provisions specified under subdivisions 4 through 10 of 12VAC5-421-100.^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, 2, and 3 of 12VAC5-421-90 and subdivision 4 a, 5 a, 6 a, 7, or 8 a of 12VAC5-421-90 and with the provisions specified under subdivisions 1 through 8 of 12VAC5-421-100;^P or

2. Comply with a restriction as specified under subdivisions subdivision 4 b, 5 b, 6 b, 7, or 8 b of 12VAC5-421-90, or subdivision 8, 9, or 10 of 12VAC5-421-90 and comply with the provisions specified under subdivisions 4 through 10 of 12VAC5-421-100.^P

12VAC5-421-90. Exclusions and restrictions.

The person in charge shall exclude or restrict a food employee from a food establishment in accordance with the following:

1. Except when the symptom is from a noninfectious condition, exclude a food employee if the food employee is:

a. Symptomatic with vomiting or diarrhea;^P or

b. Symptomatic with vomiting or diarrhea and diagnosed with an infection from Norovirus, Shigella spp., Salmonella (nontyphoidal), or Shiga toxin-producing Escherichia coli.^P

2. Exclude a food employee who is:

a. Jaundiced and the onset of jaundice occurred within the last seven calendar days, unless the food employee provides to the person in charge written medical documentation from a health practitioner specifying that the jaundice is not caused by Hepatitis A virus or other fecal-orally transmitted infection;^P

b. Diagnosed with an infection from Hepatitis A virus within 14 calendar days from the onset of any illness symptoms, or within seven calendar days of the onset of jaundice;^P or

c. Diagnosed with an infection from Hepatitis A virus without developing symptoms.^P

3. Exclude a food employee who is diagnosed with typhoid Typhoid fever, or reports having had typhoid Typhoid fever within the past three months as specified in 12VAC5-421-80 A 3.^P

4. If a food employee is diagnosed with an infection from Norovirus and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

5. If a food employee is diagnosed with an infection from Shigella spp. and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

6. If a food employee is diagnosed with an infection from Shiga toxin-producing Escherichia coli, and is asymptomatic:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

7. If a food employee is diagnosed with an infection from Salmonella (nontyphoidal) and is asymptomatic, restrict the food employee who works in a food establishment:

a. Serving a highly susceptible population,^P or

b. Not serving a highly susceptible population.^P

8. If a food employee is ill with symptoms of acute onset of sore throat with fever:

a. Exclude the food employee who works in a food establishment serving a highly susceptible population;^P or

b. Restrict the food employee who works in a food establishment not serving a highly susceptible population.^P

9. If a food employee is infected with a skin lesion containing pus such as a boil or infected wound that is open or draining and not properly covered as specified under 12VAC5-421-80 A 1 e, restrict the food employee.^P

10. If a food employee is exposed to a foodborne pathogen as specified under 12VAC5-421-80 A 4 or 5, restrict the food employee who works in a food establishment serving a highly susceptible population.^P

12VAC5-421-100. Removal, adjustment, or retention of exclusions and restrictions.

The person in charge shall adhere to the following conditions when removing, adjusting, or retaining the exclusion or restriction of a food employee:

1. Except when a food employee is diagnosed with typhoid Typhoid fever or an infection from Hepatitis A virus:

a. Reinstate a food employee who was excluded as specified under subdivision 1 a of 12VAC5-421-90 if the food employee:

(1) Is asymptomatic for at least 24 hours;^P or

(2) Provides to the person in charge written medical documentation from a health practitioner that states the symptom is from a noninfectious condition.^P

b. If a food employee was diagnosed with an infection from Norovirus and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 4 a or b of this section are met.^P

c. If a food employee was diagnosed with an infection from Shigella spp. and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic, for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 5 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 5 a or b, or 5 a and 1 c (1) of this section are met.^P

d. If a food employee was diagnosed with an infection from Shiga toxin-producing Escherichia coli and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee, who is asymptomatic for at least 24 hours and works in a food establishment not serving a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b of this section are met;^P or

(2) Retain the exclusion for the food employee, who is asymptomatic for at least 24 hours and works in a food establishment that serves a highly susceptible population, until the conditions for reinstatement as specified in subdivision 6 a or b are met.^P

e. If a food employee was diagnosed with an infection from Salmonella (nontyphoidal) and excluded as specified under subdivision 1 b of 12VAC5-421-90:

(1) Restrict the food employee who is asymptomatic for at least 30 days until conditions for reinstatement as specified under subdivision 7 a or 7 b of this section are met;^P or

(2) Retain the exclusion for the food employee who is symptomatic, until conditions for reinstatement as specified under subdivision 7 a or 7 b of this section are met. ^P

2. Reinstate a food employee who was excluded as specified under subdivision 2 of 12VAC5-421-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The food employee has been jaundiced for more than seven calendar days;^P

b. The anicteric food employee has been symptomatic with symptoms other than jaundice for more than 14 calendar days;^P or

c. The food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Hepatitis A virus infection.^P

3. Reinstate a food employee who was excluded as specified under subdivision 3 of 12VAC5-421-90 if:

a. The person in charge obtains approval from the regulatory authority department;^P and

b. The food employee provides to the person in charge written medical documentation from a health practitioner that states the employee is free from typhoid Typhoid fever.^P

4. Reinstate a food employee who was excluded as specified under subdivision 1 b or 4 a of 12VAC5-421-90, who was restricted under subdivision 4 b of 12VAC5-421-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Norovirus infection;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than 48 hours have passed since the food employee became symptomatic asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than 48 hours have passed since the food employee was diagnosed.^P

5. Reinstate a food employee who was excluded as specified under subdivision 1 b or 5 a of 12VAC5-421-90 or who was restricted under subdivision 5 b of 12VAC5-421-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Shigella spp. infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics,^P and

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved, and more than seven calendar days have passed since the food employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than seven calendar days have passed since the food employee was diagnosed.^P

6. Reinstate a food employee who was excluded or restricted as specified under subdivision 1 b or 6 a of 12VAC5-421-90 or who was restricted under subdivision 6 b of 12VAC5-421-90 if the person in charge obtains approval from the regulatory authority department and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of an infection from Shiga toxin-producing Escherichia coli based on test results that show two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after the discontinuance of antibiotics;^P and

(2) At least 24 hours apart;^P

b. The food employee was excluded or restricted after symptoms of vomiting or diarrhea resolved and more than seven calendar days have passed since the employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than seven days have passed since the employee was diagnosed.^P

7. Reinstate a food employee who was excluded as specified under subsection 1 ab of 12VAC5-421-90 or who was restricted as specified under subsection 7 of 12VAC5-421-90 if the person in charge obtains approval from the regulatory authority^P department^P and one of the following conditions is met:

a. The excluded or restricted food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee is free of a Salmonella (nontyphoidal) infection based on test results showing two consecutive negative stool specimen cultures that are taken:

(1) Not earlier than 48 hours after discontinuance of antibiotics;^P and

(2) At least 24 hours apart;^P

b. The food employee was restricted after symptoms of vomiting or diarrhea resolved, and more than 30 days have passed since the food employee became asymptomatic;^P or

c. The food employee was excluded or restricted and did not develop symptoms and more than 30 days have passed since the food employee was diagnosed.^P

8. Reinstate a food employee who was excluded or restricted as specified under subdivision 8 a or b of 12VAC5-421-90 if the food employee provides to the person in charge written medical documentation from a health practitioner stating that the food employee meets one of the following conditions:

a. Has received antibiotic therapy for Streptococcus pyogenes infection for more than 24 hours;^P

b. Has at least one negative throat specimen culture for Streptococcus pyogenes infection;^P or

c. Is otherwise determined by a health practitioner to be free of Streptococcus pyogenes infection.^P

9. Reinstate a food employee who was restricted as specified under subdivision 9 of 12VAC5-421-90 if the skin, infected wound, cut, or pustular boil is properly covered with one of the following:

a. An impermeable cover such as a finger cot or stall and a single-use glove over the impermeable cover if the infected wound or pustular boil is on the hand, finger, or wrist;^P

b. An impermeable cover on the arm if the infected wound or pustular boil is on the arm;^P or

c. A dry, durable, tight-fitting bandage if the infected wound or pustular boil is on another part of the body.^P

10. Reinstate a food employee who was restricted as specified under subdivision 10 of 12VAC5-421-90 and was exposed to one of the following pathogens as specified under 12VAC5-421-80 A 4 or 5:

a. Norovirus and one of the following conditions is met:

(1) More than 48 hours have passed since the last day the food employee was potentially exposed;^P or

(2) More than 48 hours have passed since the food employee's household contact became asymptomatic.^P

b. Shigella spp. or Shiga toxin-producing Escherichia coli and one of the following conditions is met:

(1) More than three calendar days have passed since the last day the food employee was potentially exposed;^P or

(2) More than three calendar days have passed since the food employee's household contact became asymptomatic.^P

c. Typhoid fever (caused by Salmonella typhi) and one of the following conditions is met:

(1) More than 14 calendar days have passed since the last day the food employee was potentially exposed;^P or

(2) More than 14 calendar days have passed since the food employee's household contact became asymptomatic.^P

d. Hepatitis A virus and one of the following conditions is met:

(1) The food employee is immune to Hepatitis A virus infection because of prior illness from Hepatitis A;^P

(2) The food employee is immune to Hepatitis A virus infection because of vaccination against Hepatitis A;^P

(3) The food employee is immune to Hepatitis A virus infection because of IgG administration;^P

(4) More than 30 calendar days have passed since the last time the food employee was potentially exposed;^P

(5) More than 30 calendar days have passed since the food employee's household contact became jaundiced;^P or

(6) The food employee does not use an alternative procedure that allows bare hand contact with ready-to-eat food until at least 30 days after the potential exposure, as specified in subdivisions 10 d (4) and (5) of this section, and the food employee receives additional training about:

(a) Hepatitis A symptoms and preventing the transmission of infection;^P

(b) Proper handwashing procedures;^P and

(c) Protecting ready-to-eat food from contamination introduced by bare hand contact.^P

12VAC5-421-180. Hand antiseptics.

A. A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall:

1. Comply with one of the following:

a. Be an approved drug that is listed in the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations," 34th Edition, 2014, 39th Edition, 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 monograph for OTC (over the counter) Health-Care Antiseptic Drug Products as an antiseptic handwash;^Pf

2. Consist only of components which 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 184, or 21 CFR Part 186 for use in contact with food and in FDA's Inventory of GRAS Notices;^Pf

d. A prior sanction listed under 21 CFR 181;^Pf or

e. A Food Contact Notification food contact notification that is effective;^Pf and

3. Be applied only to hands that are cleaned as specified under 12VAC5-421-140.^Pf

B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in subdivision A 2 of this section, use shall be:

1. Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves;^Pf or

2. Limited to situations that involve no direct contact with food by the bare hands.^Pf

C. A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 ppm (mg/l) chlorine or above.^Pf

12VAC5-421-190. Maintenance of fingernails.

A. Food employees shall keep their fingernails trimmed, filed, and maintained so the edges and surfaces are cleanable and not rough.^Pf

B. Unless wearing intact gloves in good repair, a food employee shall not wear fingernail polish or artificial nails when working with exposed food.^Pf

12VAC5-421-235. 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 the food employee working with exposed food shall be covered with a single-use glove.

12VAC5-421-255. Clean-up of vomiting and diarrheal events.

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. 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

12VAC5-421-260. Safe and, unadulterated, and honestly presented.

Food shall be safe, and unadulterated, and, as specified in 12VAC5-421-890, honestly presented.^PfP

12VAC5-421-270. Compliance with food law.

A. Food shall be obtained from sources that comply with law.^P

B. Food prepared in a private home shall not be used or offered for human consumption in a food establishment unless the home kitchen is inspected and regulated by the Virginia Department of Agriculture and Consumer Services.^P

C. Packaged food shall be labeled as specified in law, including 21 CFR Part 101, 9 CFR Part 317, and Subpart N of 9 CFR Part 381, and as specified under 12VAC5-421-400 and 12VAC5-421-410.^Pf

D. Fish, other than those specified in 12VAC5-421-730 B, that are intended for consumption in raw or undercooked form and allowed as specified in 12VAC5-421-700 D, may be offered for sale or service if they are obtained from a supplier that freezes fish as specified under 12VAC5-421-730 A; or if they are frozen on premises as specified under 12VAC5-421-730 A and records are retained as specified under 12VAC5-421-740.

E. Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory as specified in 12VAC5-421-700 C shall be:

1. Obtained from a food processing plant that, upon request by the purchaser, packages the steaks and labels them to indicate that they meet the definition of whole-muscle, intact beef;^Pf or

2. Deemed acceptable by the regulatory authority department based on other evidence, such as written buyer specifications or invoices, that indicates that the steaks meet the definition of whole-muscle, intact beef;^Pf and

3. If individually cut in a food establishment:

a. Cut from whole-muscle intact beef that is labeled by a food processing plant as specified in subdivision 1 of this subsection or identified as specified in subdivision 2 of this subsection;^PfP

b. Prepared so they remain intact;^Pf and

c. If packaged for undercooking in a food establishment, labeled as specified in subdivision 1 of this subsection or identified as specified in subdivision 2 of this subsection.^Pf

F. Meat and poultry that are is not a ready-to-eat food and are is in a packaged form when offered for sale or otherwise offered for consumption shall be labeled to include safe handling instructions as specified in law, including 9 CFR 317.2(l) and 9 CFR 381.125(b).

G. Shell eggs Eggs that have not been specifically treated to destroy all viable Salmonellae shall be labeled to include safe handling instructions as specified in law, including 21 CFR 101.17(h).

12VAC5-421-295. Juice treated.

Prepackaged juice shall:

1. Be obtained from a processor with a HACCP system as specified in 21 CFR Part 120;^Pf and

2. Be obtained pasteurized or otherwise treated to attain a five-log reduction of the most resistant microorganism of public health significance as specified in 21 CFR 120.24.^P

12VAC5-421-300. 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 agency of competent jurisdiction.^P

B. Molluscan shellfish that are recreationally caught shall not be received for sale or service.^P

12VAC5-421-310. Molluscan shellfish.

A. Molluscan shellfish shall be obtained from sources according to law and the requirements specified in the U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, National Shellfish Sanitation Program (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 (U.S. Food and Drug Administration).^P

12VAC5-421-340. Temperature.

A. Except as specified in subsection B of this section, refrigerated, time/temperature control for safety food shall be at a temperature of 41°F (5°C) or below when received.^P

B. If a temperature other than 41°F (5°C) for a time/temperature control for safety food is specified in law governing its distribution, such as laws governing milk and molluscan shellfish, the food may be received at the specified temperature.

C. Raw shell eggs shall be received in refrigerated equipment that maintains an ambient air temperature of 45°F (7°C) or less.^P

D. t Time/temperature control for safety food that is cooked to a temperature and for a time specified under 12VAC5-421-700, 12VAC5-421-710, and 12VAC5-421-720 and received hot shall be at a temperature of 135° (57°C) or above.^P

E. A food that is labeled frozen and shipped frozen by a food processing plant shall be received frozen.^Pf

F. Upon receipt, time/temperature control for safety food shall be free of evidence of previous temperature abuse.^Pf

12VAC5-421-350. Additives.

Food shall not contain unapproved food additives or additives that exceed amounts allowed specified in 21 CFR Parts 170-180 relating to food additives; generally recognized as safe (GRAS) or prior sanctioned substances that exceed amounts allowed in 21 CFR Parts 181-186; substances that exceed amounts specified in 9 CFR 424.21(b), Subpart C; or pesticide residues that exceed provisions specified in 40 CFR Part 185 180 and exceptions.^P

12VAC5-421-400. 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 The 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 (1.89 L) 64 fluid ounces (1.89L) or the date shucked for packages with a capacity of one-half gallon (1.89 L) 64 fluid ounces (1.89L) or more.^Pf

B. A package of raw shucked shellfish that does not bear a label or that bears a label which does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D.

12VAC5-421-410. Shellstock identification.

A. Shellstock shall be obtained in containers bearing legible source identification tags or labels that are affixed by a 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 2017 Revision, (U.S. Food and Drug Administration), and that include the following information:^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, as applicable, country of harvest.;^Pf

6. The type and quantity of shellstock.;^Pf

7. The following statement in bold, capitalized type: "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. All shellstock intended for raw consumption shall include a consumer advisory using the statement from 12VAC5-421-930 C, or an equivalent statement.

B. A container of shellstock that does not bear a tag or label or that bears a tag or label that does not contain all the information as specified under subsection A of this section shall be subject to a hold order, as allowed by law, or seizure and destruction in accordance with 21 CFR 1240.60(d), Subpart D.

12VAC5-421-440. 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 C 1 of this section,^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

12VAC5-421-450. Preventing contamination from hands.

A. Food employees shall wash their hands as specified under 12VAC5-421-140.

B. Except when washing fruits and vegetables as specified under 12VAC5-421-510 or as specified in subsections D and E of this section, food employees shall not contact exposed, ready-to-eat food with their bare hands and shall use suitable utensils such as deli tissue, spatulas, tongs, single-use gloves, or dispensing equipment.^P

C. Food employees shall minimize bare hand and arm contact with exposed food that is not in a ready-to-eat form.^Pf

D. Subsection B of this section does not apply to a food employee who contacts exposed, ready-to-eat food with bare hands at the time the ready-to-eat food is being added as an ingredient to food that:

1. Contains a raw animal food and is to be cooked in the food establishment to heat all parts of the food to the minimum temperatures specified in subsection A or B of 12VAC5-421-700 or in 12VAC5-421-710; or

2. Does not contain a raw animal food but is to be cooked in the food establishment to heat all parts of the food to a temperature of at least 145°F (63°C).

E. Food employees not serving a highly susceptible population may contact exposed, ready-to-eat food with their bare hands if:

1. The permit holder obtains prior approval from the regulatory authority department;

2. Written procedures are maintained in the food establishment and made available to the regulatory authority department upon request that include:

a. For each bare hand contact procedure, a listing of the specific ready-to-eat foods that are touched by bare hands;

b. Diagrams and other information showing that handwashing facilities, installed, located, equipped, and maintained as specified under 12VAC5-421-2230, 12VAC5-421-2280, 12VAC5-421-2310, 12VAC5-421-3020, 12VAC5-421-3030, and 12VAC5-421-3045 are in an easily accessible location and in close proximity to the work station where the bare hand contact procedure is conducted;

3. A written employee health policy that details how the food establishment complies with 12VAC5-421-80, 12VAC5-421-90, and 12VAC5-421-100 including:

a. Documentation that the food employees and conditional employees acknowledge that they are informed to report information about their health and activities as they relate to gastrointestinal symptoms and diseases that are transmittable through food as specified under 12VAC5-421-80 A;

b. Documentation that food employees and conditional employees acknowledge their responsibilities as specified under 12VAC5-421-80 E and F; and

c. Documentation that the person in charge acknowledges the responsibilities as specified under 12VAC5-421-80 B, C, and D, and 12VAC5-421-90 and 12VAC5-421-100;

4. Documentation that the food employees acknowledge that they have received training in:

a. The risks of contacting the specific ready-to-eat foods with their bare hands;

b. Proper handwashing as specified under 12VAC5-421-140;

c. When to wash their hands as specified under 12VAC5-421-160;

d. Where to wash their hands as specified under 12VAC5-421-170;

e. Proper fingernail maintenance as specified under 12VAC5-421-190;

f. Prohibition of jewelry as specified under 12VAC5-421-200; and

g. Good hygienic practices as specified under 12VAC5-421-220 and 12VAC5-421-230;

5. Documentation that hands are washed before food preparation and as necessary to prevent cross-contamination by food employees as specified under 12VAC5-421-130 through 12VAC5-421-170 during all hours of operation when the specific ready-to-eat foods are prepared;

6. Documentation that food employees contacting ready-to-eat food with bare hands use two or more of the following control measures to provide additional safeguards to hazards associated with bare hand contact:

a. Double handwashing;

b. Nail brushes;

c. A hand antiseptic after handwashing as specified under 12VAC5-421-180;

d. Incentive programs such as paid sick leave that assist or encourage food employees not to work when they are ill; or

e. Other control measures approved by the regulatory authority department; and

7. Documentation that corrective action is taken when subdivisions 1 through 6 of this subsection are not followed.

12VAC5-421-470. 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 d of this subsection, separating raw animal foods during storage, preparation, holding, and display from:

a. Raw ready-to-eat food including other raw animal food such as fish for sushi or molluscan shellfish, or other raw ready-to-eat food such as fruits and vegetables,;^P and

b. Cooked ready-to-eat food.;^P

c. Fruits and vegetables before they are washed;^P and

c. d. Frozen, commercially processed, and packaged raw animal food may be stored or displayed with or above frozen, commercially processed and packaged, ready-to-eat food;

2. Except when combined as ingredients, separating types of raw animal foods from each other such as beef, fish, lamb, pork, and poultry during storage, preparation, holding, and display by:

a. Using separate equipment for each type,;^P or

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 12VAC5-421-1780 A and sanitizing as specified under 12VAC5-421-1900;

4. Except as specified in subsection B of this section and 12VAC5-421-810 B 2, 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 12VAC5-421-3150; and

8. Separating fruits and vegetables, before they are washed as specified under 12VAC5-421-510 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 12VAC5-421-810 B 2; or

5. Shellstock.

12VAC5-421-540. Food contact with equipment and utensils.

Food shall only contact surfaces of:

1. Equipment and utensils that are cleaned as specified under 12VAC5-421-1770 through 12VAC5-421-1870 12VAC5-421-1860 and sanitized as specified under 12VAC5-421-1885, 12VAC5-421-1890 and 12VAC5-421-1900;^P

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

3. Linens, such as cloth napkins, as specified under 12VAC5-421-560 that are laundered as specified under 12VAC5-421-1920 C.^P

12VAC5-421-660. Condiments; protection.

A. Condiments shall be protected from contamination by being kept in dispensers that are designed to provide protection, protected food displays provided with the proper utensils, original containers designed for dispensing, or individual packages or portions.

B. Condiments at a vending machine location shall be in individual packages or provided in dispensers that are filled at a location that is approved by the regulatory authority department, such as the food establishment that provides food to the vending machine location, a food processing plant that is regulated by the agency that has jurisdiction over the operation, or a properly equipped facility that is located on the site of the vending machine location.

12VAC5-421-700. 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 game animals under a voluntary inspection program as specified under 12VAC5-421-330 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 and, mechanically tenderized meats, and injected meats; the following if they are comminuted: fish, meat, game animals commercially raised for food and game animals under a voluntary inspection program as specified under 12VAC5-421-330 A 1; and raw eggs that are not prepared as specified under subdivision 1 a of this subsection:^P

	Minimum
	Temperature °F (°C)	Time
	145 (63)	3 minutes
	150 (66)	1 minute
	158 (70)	<1 second (instantaneous)

; or

3. 165°F (74°C) or above for 15 seconds less than one second (instantaneous) for poultry, baluts, wild game animals as specified under 12VAC5-421-330 A 2, 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. 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.

; and

1. In 2. 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 and

^f

	Oven Type	Oven Temperature Based on Roast Weight
		Less than 10 lbs (4.5 kg)	10 lbs (4.5 kg) or more
	Still Dry	350°F (177°C) or more	250°F (121°C) or more
	Convection	325°F (163°C) or more	250°F (121°C) or more
	High Humidity1	250°F (121°C) or less	250°F (121°C) or less
	1Relative humidity greater than 90% for at least one hour as measured in the cooking chamber or exit of the oven; or in a moisture-impermeable bag that provides 100% humidity.

2. As specified in the following chart, to heat all parts of the food to a temperature and for the holding time that corresponds to that temperature.^P

	Temperature °F (°C)	Time1 in Minutes	Temperature °F (°C)	Time1 in Seconds
	130 (54.4)	112	147 (63.9)	134
	131 (55.0)	89	149 (65.0)	85
	133 (56.1)	56	151 (66.1)	54
	135 (57.2)	36	153 (67.2)	34
	136 (57.8)	28	155 (68.3)	22
	138 (58.9)	18	157 (69.4)	14
	140 (60.0)	12	158 (70.0)	0
	142 (61.1)	8
	144 (62.2)	5
	145 (62.8)	4
	1Holding time may include postoven heat rise.

C. A raw or undercooked whole-muscle, intact beef steak may be served or offered for sale in a ready-to-eat form if:

1. The food establishment serves a population that is not a highly susceptible population;

2. The steak is labeled, as specified under 12VAC5-421-270 E, to indicate that it meets the definition of "whole-muscle, intact beef"; and

3. The steak is cooked on both the top and bottom to a surface temperature of 145°F (63°C) or above and a cooked color change is achieved on all external surfaces.

D. A raw animal food such as raw egg, raw fish, raw-marinated fish, raw molluscan shellfish, or steak tartare, or a partially cooked food such as lightly cooked fish, soft cooked eggs, or rare meat other than whole-muscle, intact beef steaks as specified in subsection C of this section, may be served or offered for sale upon request or consumer selection in a ready-to-eat form if:

1. As specified under subdivisions 3 a and b of 12VAC5-421-950 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 12VAC5-421-930 that to ensure its safety, the food should be cooked as specified under subsection A or B of this section; or

4. The regulatory authority department grants a variance from subsection A or B of this section as specified in 12VAC5-421-3570 based on a HACCP plan that:

a. Is submitted by the permit holder and approved as specified under 12VAC5-421-3570;

b. Documents scientific data or other information that shows 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.

12VAC5-421-720. 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

12VAC5-421-725. Noncontinuous cooking.

Raw animal foods that are cooked using a noncontinuous cooking process shall be:

1. Subject to an initial heating process that is no longer than 60 minutes in duration;^P

2. Immediately after initial heating, cooled according to the time and temperature requirements specified for cooked time/temperature control for safety food under 12VAC5-421-800 A;^P

3. After cooling, held frozen or cold, as specified for time/temperature control for safety food under 12VAC5-421-820 A 2;^P

4. Prior to sale or service, cooked using a process that heats all parts of the food to a temperature and for a time as designated in 12VAC5-421-700 A, B, and C;^P

5. Cooled according to the time and temperature parameters specified for cooked time/temperature control for safety food under 12VAC5-421-800 A if not either hot held as specified under 12VAC5-421-820 A 1, served immediately, or held using time as a public health control as specified under 12VAC5-421-850 after complete cooling;^P and

6. Prepared and stored according to written procedures that:

a. Have obtained prior approval from the regulatory authority department;^Pf

b. Are maintained in the food establishment and are made available to the regulatory authority department upon request;^Pf

c. Describe how the requirements specified under subdivisions 1 through 5 of this section are to be monitored and documented by the permit holder and the corrective actions to be taken if the requirements are not met;^Pf

d. Describe how the foods, after initial heating, but prior to complete cooking, are to be marked or otherwise identified as foods that must be cooked as specified under subdivision 4 of this section prior to being offered for sale or service;^Pf and

e. Describe how the foods, after initial heating but prior to cooking as specified in subdivision 4 of this section, are to be separated from ready-to-eat foods as specified under 12VAC5-421-470 A.^Pf

12VAC5-421-730. 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, including the shucked adductor muscle of scallops;

2. A scallop product consisting only of the shucked 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);

3. 4. Aquacultured fish, such as salmon, that:

a. If raised in open water, are raised in net-pens; or

b. Are raised in land-based operations such as ponds or tanks; and

c. Are fed formulated feed, such as pellets, that contains no live parasites infective to the aquacultured fish, or

4. 5. Fish eggs that have been removed from the skein and rinsed.

12VAC5-421-740. Records, creation and retention.

A. Except as specified in 12VAC5-421-730 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 12VAC5-421-730 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 12VAC5-421-730 B 3 4, a written agreement or statement from the supplier or aquaculturist stipulating that the fish were raised and fed as specified in 12VAC5-421-730 B 3 4 shall be obtained by the person in charge and retained in the records of the food establishment for 90 calendar days beyond the time of service or sale of the fish.^Pf

12VAC5-421-760. Reheating for hot holding.

A. Except as specified under subsections B, C, and E of this section, time/temperature control for safety food that is cooked, cooled, and reheated for hot holding shall be reheated so that all parts of the food reach at least 165°F (74°C) for 15 seconds.^P

B. Except as specified under subsection C of this section, time/temperature control for safety food reheated in a microwave oven for hot holding shall be reheated so that all parts of the food reach a temperature of at least 165°F (74°C) and the food is rotated or stirred, covered, and allowed to stand covered two minutes after reheating.^P

C. Ready-to-eat time/temperature control for safety food that has been commercially processed and packaged in a food processing plant that is inspected by the regulatory authority department that has jurisdiction over the plant shall be heated to a temperature of at least 135°F (57°C) when being reheated for hot holding.^P

D. Reheating for hot holding as specified under subsections A, B, and C of this section shall be done rapidly and the time the food is between 41°F (5°C) and the temperatures specified under subsections A, B, and C of this section may not exceed two hours.^P

E. Remaining unsliced portions of meat roasts that are cooked as specified under 12VAC5-421-700 B may be reheated for hot holding using the oven parameters and minimum time and temperature conditions specified under 12VAC5-421-700 B.

12VAC5-421-830. Ready-to-eat, time/temperature control for safety food; date marking.

A. Except when packaging food using a reduced oxygen packaging method as specified under 12VAC5-421-870, and except as specified in subsections D and E and F of this section, refrigerated ready-to-eat time/temperature control for safety food prepared and held in a food establishment for more than 24 hours shall be clearly marked to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded when held at a temperature of 41°F (5°C) or less for a maximum of seven days. The day of preparation shall be counted as day 1.^Pf

B. Except as specified in subsections D, E, F, and F G of this section, refrigerated ready-to-eat, time/temperature control for safety food prepared and packaged by a food processing plant shall be clearly marked at the time the original container is opened in a food establishment and if the food is held for more than 24 hours, to indicate the date or day by which the food shall be consumed on the premises, sold, or discarded, based on the temperature and time combinations specified in subsection A of this section and:^Pf

1. The day the original container is opened in the food establishment shall be counted as day 1;^Pf and

2. The day or date marked by the food establishment shall not exceed a manufacturer's "use by" date if the manufacturer determined the "use by" date based on food safety.^Pf

C. A refrigerated, ready-to-eat, time/temperature control for safety food ingredient or a portion of a refrigerated, ready-to-eat, time/temperature control for safety food that is subsequently combined with additional ingredients or portions of food shall retain the date marking of the earliest-prepared or first-prepared ingredient.^Pf

D. A date marking system that meets the criteria specified in subsections A and B of this section may include:

1. Using a method approved by the regulatory authority department for refrigerated, ready-to-eat time/temperature control for safety food that is frequently rewrapped, such as lunchmeat or a roast, or for which date marking is impractical, such as soft-serve mix or milk in a dispensing machine;

2. Marking the date or day of preparation, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified in subsection A of this section;

3. Marking the date or day the original container is opened in a food establishment, with a procedure to discard the food on or before the last date or day by which the food must be consumed on the premises, sold, or discarded as specified under subsection B of this section; or

4. Using calendar dates, days of the week, color-coded marks, or other effective marking methods, provided that the marking system is disclosed to the regulatory authority department upon request.

E. Subsections A and B of this section do not apply to individual meal portions served or repackaged for sale from a bulk container upon a consumer's request.

F. Subsections A and B of this section do not apply to shellstock.

G. Subsection B of this section does not apply to the following foods prepared and packaged by a food processing plant inspected by a regulatory authority:

1. Deli salads, such as ham salad, seafood salad, chicken salad, egg salad, pasta salad, potato salad, and macaroni salad, manufactured in accordance with 21 CFR Part 110;

2. Hard cheeses containing not more than 39% moisture as defined in 21 CFR Part 133, such as cheddar, gruyere, parmesan and reggiano, and romano;

3. Semi-soft cheese containing more than 39% moisture, but not more than 50% moisture, as defined in 21 CFR Part 133, such as blue, edam, gorgonzola, gouda, and monterey jack;

4. Cultured dairy products as defined in 21 CFR Part 131, such as yogurt, sour cream, and buttermilk;

5. Preserved fish products, such as pickled herring and dried or salted cod, and other acidified fish products as defined in 21 CFR Part 114;

6. Shelf stable, dry fermented sausages, such as pepperoni and Genoa salami; and

7. Shelf stable salt-cured products such as prosciutto and Parma (ham).

12VAC5-421-850. 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 procedures shall be prepared in advance, maintained in the food establishment, and made available to the regulatory authority department upon request that specify:^Pf

1. Methods of compliance with subdivisions subsection B 1, 2, and 3 or C 1 through 5 of this section;^Pf and

2. Methods of compliance with 12VAC5-421-800 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 four hours:

1. The food shall have an initial temperature of 41°F (5°C) or less when removed from cold holding temperature control or 135°F (57°C) or greater when removed from hot holding temperature control;^P

2. The food shall be marked or otherwise identified to indicate the time that is four hours past the point in time when the food is removed from temperature control;^{P Pf}

3. The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within four hours from the point in time when the food is removed from temperature control;^P and

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

C. If time without temperature control is used as the public health control up to a maximum of six hours:

1. The food shall have an initial temperature of 41ºF (5ºC) or less when removed from temperature control and the food temperature may not exceed 70ºF (21ºC) 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 70ºF (21ºC) during the six-hour period, unless an ambient air temperature is maintained that ensures the food does not exceed 70ºF (21ºC) during the six-hour holding period;^PPf

3. The food shall be marked or otherwise identified to indicate:^Pf

a. The time when the food is removed from 41ºF (5ºC) 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 41ºF (5ºC) or less cold-holding temperature control;^Pf

4. The food shall be:

a. Discarded if the temperature of the foods exceeds 70ºF (21ºC);^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 41ºF (5ºC) 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.

12VAC5-421-860. Variance requirement.

A food establishment shall obtain a variance from the regulatory authority department as specified in 12VAC5-421-3570 and 12VAC5-421-3580 before:^Pf

1. Smoking food as a method of food preservation rather than as a method of flavor enhancement; ^Pf

2. Curing food;^Pf

3. Using food additives or adding components such as vinegar:^Pf

a. As a method of food preservation rather than as a method of flavor enhancement;^Pf or

b. To render a food so that it is not a time/temperature control for safety food; ^Pf

4. Packaging time/temperature control for safety food using a reduced oxygen packaging method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under 12VAC5-421-870;^Pf

5. Operating a molluscan shellfish life-support system display tank used to store or display shellfish that are offered for human consumption;^Pf

6. Custom processing animals that are for personal use as food and not for sale or service in a food establishment;^Pf

7. Sprouting seeds or beans;^Pf or

8. Preparing food by another method that is determined by the regulatory authority department to require a variance.^Pf

12VAC5-421-870. Reduced oxygen packaging without a variance, criteria.

A. Except for a food establishment that obtains a variance as specified under 12VAC5-421-860, 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 under subsection F of this section, a food establishment that packages time/temperature control for safety food using a reduced oxygen method shall have implement a HACCP plan that contains the following information specified under subdivisions 3 and 4 of 12VAC5-421-3630 and that:^Pf

1. Identifies food to be packaged;^Pf

2. Except as specified in subsections C, D, and E of this section and as specified in subsection D of this section, requires that the packaged food shall be maintained at 41°F (5°C) or less and meet at least one of the following criteria:^Pf

a. Has an A_w of 0.91 or less,;^Pf

b. Has a pH of 4.6 or less,;^Pf

c. Is a meat or poultry product cured at a food processing plant regulated by the USDA using substances specified in 9 CFR 424.21 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

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 food at 41°F (5°C) or below,;^Pf and

b. 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

4. 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. Includes operational procedures that:

a. Prohibit contacting ready-to-eat food with bare hands as specified in 12VAC5-421-450 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

6. Describes the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:^Pf

a. Concepts required for safe operation,;^Pf

b. Equipment and facilities,;^Pf and

c. Procedures specified under subdivision B 5 of this section and subdivisions 3 and 4 of 12VAC5-421-3630; ^Pf and

7. Is provided to the regulatory authority department prior to implementation as specified under 12VAC5-421-3620 B.

C. Except for fish that is frozen before, during, and after packaging and 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 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 regulatory authority department prior to implementation a HACCP plan that contains the information as specified under subdivisions 3 and 4 of 12VAC5-421-3630;^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 bagged 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 subsections A, B, and C of 12VAC5-421-700;^P

c. Protected from contamination before and after cooking as specified in 12VAC5-421-450 through 12VAC5-421-765;^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 as specified under 12VAC5-421-800,; 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 days after the date of packaging;^P

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

(3) Held frozen with no shelf-life restriction while frozen until consumed or used;^P

f. Held in a refrigeration unit that is equipped with an electronic system that continuously monitors time and temperature and is visually examined for proper operation twice daily;^Pf

g. If transported off site to a satellite location of the same business entity, equipped with verifiable electronic monitoring devices to ensure that times and temperatures are monitored during transportation;^Pf and

h. Labeled with the product name and the date packaged; ^Pf and

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

a. Made available to the regulatory authority department upon request,;^Pf and

b. Held for six months;^Pf and

4. Implement written operational procedures as specified under subdivision B 5 of this section and a training program as specified under subdivision B 6 of this section.^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 12VAC5-421-3630 and as specified under 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. 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.

12VAC5-421-900. Food labels.

A. Food packaged in a food establishment, shall be labeled as specified in accordance with all applicable laws and regulations, including 21 CFR Part 101 and 9 CFR Part 317.

B. Label information shall include:

1. The common name of the food, or absent a common name, an adequately descriptive identity statement;

2. If made from two or more ingredients, a list of ingredients and sub-ingredients in descending order of predominance by weight, including a declaration of artificial colors, artificial flavors, and chemical preservatives, if contained in the food;

3. An accurate declaration of the net quantity of contents;

4. The name and place of business of the manufacturer, packer, or distributor; and

5. The name of the food source for each major food allergen contained in the food unless the food source is already part of the common or usual name of the respective ingredient;^Pf

6. Except as exempted in the Federal Food, Drug, and Cosmetic Act § 403(Q)(3) through (5), nutrition labeling as specified in 21 CFR Part 101 and 9 CFR Part 317, Subpart B; and

7. For any salmonid fish containing canthaxanthin or astaxanthin as a color additive, the labeling of the bulk fish container, including a list of ingredients, displayed on the retail container or by other written means, such as a counter card, that discloses the use of canthaxanthin or astaxanthin.

C. Bulk food that is available for consumer self-dispensing shall be prominently labeled with the following information in plain view of the consumer:

1. The manufacturer's or processor's label that was provided with the food; or

2. A card, sign, or other method of notification that includes the information specified under subdivisions B 1, 2, and 5 6 of this section.

D. Bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification need not be labeled if:

1. A health, nutrient content, or other claim is not made;

2. There are no state or local laws requiring labeling; and

3. The food is manufactured or prepared on the premises of the food establishment or at another food establishment or a food processing plant that is owned by the same person and is regulated by the food regulatory agency that has jurisdiction.

12VAC5-421-930. Consumer advisory: consumption of animal foods that are raw, undercooked, or not otherwise processed to eliminate pathogens.

A. Except as specified in 12VAC5-421-700 C and D 4 and under subdivision 3 of 12VAC5-421-950, if an animal food such as beef, eggs, fish, lamb, pork, poultry, or shellfish is served or sold raw, undercooked, or without otherwise being processed to eliminate pathogens, either in ready-to-eat form or as an ingredient in another ready-to-eat food, the permit holder shall inform consumers of the significantly increased risk of consuming such foods by way of a disclosure and reminder, as specified in subsections B and C of this section, using brochures, deli case or menu advisories, label statements, table tents, placards, or other effective written means.^Pf

B. Disclosure shall include:

1. A description of the animal-derived foods, such as "oysters on the half shell (raw oysters)," "raw-egg Caesar salad," and "hamburgers (can be cooked to order)";^Pf or

2. Identification of the animal-derived foods by asterisking them to a footnote that states that the items are served raw or undercooked, or contain (or may contain) raw or undercooked ingredients.^Pf

C. Reminder shall include asterisking the animal-derived foods requiring disclosure to a footnote that states:

1. "Regarding the safety of these items, written information is available upon request";^Pf

2. "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness";^Pf or

3. "Consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase your risk of foodborne illness, especially if you have certain medical conditions."^Pf

12VAC5-421-940. Discarding or reconditioning unsafe, adulterated, or contaminated food.

A. A food that is unsafe, adulterated, or not from an approved source as specified under 12VAC5-421-270 through 12VAC5-421-330 honestly presented as specified in 12VAC5-421-260 shall be rendered unusable and discarded or reconditioned according to an approved procedure.^P

B. Food that is not from an approved source as specified under 12VAC5-421-270 through 12VAC5-421-330 shall be discarded.^P

C. Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under 12VAC5-421-90 shall be rendered unusable and discarded.^P

C. D. Food that is contaminated by food employees, consumers, or other persons through contact with their hands, bodily discharges, such as nasal or oral discharges, or other means shall be rendered unusable and discarded.^P

12VAC5-421-950. 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 this paragraph only, children who are age nine or less 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) (Juices that have not been specifically processed to prevent, reduce or eliminate the presence of pathogens) or a packaged juice or beverage containing juice that bears a warning label as specified under subdivision 2 of 12VAC5-421-765 may not be served or offered for sale;^P and

c. Unpackaged juice that is prepared on the premises for service or sale in a ready-to-eat form shall be processed under a HACCP plan that contains the information specified in subdivisions 2 through 3, 4, and 5 of 12VAC5-421-3630 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 bearnaise bèarnaise 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 shall 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 shall not contact ready-to-eat food as specified in 12VAC5-421-450 B and E.^P

5. Time only, as the public health control as specified under 12VAC5-421-850 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 12VAC5-421-700 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 12VAC5-421-700 A 2;

d. (4) Contains the information specified under subdivision 4 of 12VAC5-421-3630 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 12VAC5-421-680 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.

12VAC5-421-1180. Temperature measuring devices; food.

A. Food temperature measuring devices that are scaled only in Fahrenheit Celsius or dually scaled in Fahrenheit and Celsius and Fahrenheit shall be scaled in 2°F increments and accurate to ±2°F plus or minus 1°C in the intended range of use.^Pf

B. Food temperature measuring devices that are scaled only in Celsius Fahrenheit shall be scaled in 1°C increments accurate to ±1°C plus or minus 2°F in the intended range of use.^Pf

12VAC5-421-1190. Temperature measuring devices; ambient air and water.

A. Ambient air and water temperature measuring devices that are scaled in Fahrenheit Celsius or dually scaled in Fahrenheit and Celsius and Fahrenheit shall be designed to be easily readable and scaled in 3°F increments and accurate to ±3°F plus or minus 1.5°C in the intended range of use.^Pf

B. Ambient air and water temperature measuring devices that are scaled only in Celsius Fahrenheit shall be scaled in 1.5°C increments and accurate to ±1.5°C plus or minus 3°F in the intended range of use.^Pf

12VAC5-421-1300. Molluscan shellfish tanks.

A. Except as specified under subsection B of this section, molluscan shellfish life support system display tanks shall 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 and or display shellfish that are offered for human consumption shall be operated and maintained in accordance with a variance granted by the regulatory authority department as specified in 12VAC5-421-3570 and a HACCP plan that:^Pf

1. Is submitted by the permit holder and approved as specified under 12VAC5-421-3580 12VAC5-421-3620;^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 12VAC5-421-440.^Pf

12VAC5-421-1380. Warewashing machines, flow pressure device.

A. Warewashing machines that provide a fresh hot water sanitizing rinse shall be equipped with a pressure gauge or similar device such as a transducer that measures and displays the water pressure in the supply line immediately before entering the warewashing machine.; and

B. If the flow pressure measuring device is upstream of the fresh hot water sanitizing rinse control valve, the device shall be mounted in a one-fourth inch or 6.4 millimeter Iron Pipe Size (IPS) valve.

C. Subsections A and B of this section do not apply to a machine that uses only a pumped or recirculated sanitizing rinse.

D. Subsections A and B of this section shall not apply to home model dishwashers used in bed and breakfast operations serving 18 or fewer guests.

12VAC5-421-1520. Temperature measuring devices, manual and mechanical warewashing.

A. In manual warewashing operations, a temperature measuring device shall be provided and readily accessible for frequently measuring the washing and sanitizing temperatures.^Pf

B. In hot water mechanical warewashing operations, an irreversible registering temperature indicator shall be provided and readily accessible for measuring the utensil surface temperature. ^Pf

12VAC5-421-1535. Cleaning agents and sanitizers, availability.

A. Cleaning agents that are used to clean equipment and utensils as specified under Article 6 (12VAC5-421-1770 et seq.) of this part shall be provided and available for use during all hours of operation.

B. Except for chemical sanitizers that are generated on site at the time of use, chemical sanitizers that are used to sanitize equipment and utensils as specified under Article 6 7 shall be provided and available for use during all hours of operation.

12VAC5-421-1550. Fixed equipment, spacing or sealing.

A. Equipment that is fixed because it is not easily movable shall be installed so that it is:

1. Spaced to allow access for cleaning along the sides, behind, and above the equipment;

2. Spaced from adjoining equipment, walls, and ceilings a distance of not more than 1/32 inch or 1 millimeter; or

3. Sealed to adjoining equipment or walls, if the equipment is exposed to spillage or seepage.

B. Counter-mounted equipment that is not easily movable shall be installed to allow cleaning of the equipment and areas underneath and around the equipment by being:

1. Sealed to the table; or

2. Elevated on legs as specified under 12VAC5-421-1560 D.

12VAC5-421-1620. Warewashing sinks, use limitation.

A. A warewashing sink shall not be used for handwashing.

B. If a warewashing sink is used to wash wiping cloths, wash produce, or thaw food, the sink shall be cleaned as specified under 12VAC5-421-1600 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 (12VAC5-421-1880 et seq.) (12VAC5-421-1885 et seq.) of this part before and after using the sink to wash produce or thaw food.

12VAC5-421-1700. 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 12VAC5-421-1900 shall be listed in 40 CFR 180.940, shall meet the criteria as specified under 12VAC5-421-3380, 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 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) 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 40 CFR 180.940 12VAC5-421-3380 and as indicated by the manufacturer's use directions included in the labeling;^P and

c. Be used only in water with 500 mg/L hardness or less or in water having a hardness no greater than specified by the manufacturer's label;^P

4. If another solution of a chemical specified under subdivisions 1, 2 and 3 of this section is used, the permit holder shall demonstrate to the regulatory authority department that the solution achieves sanitization and the use of the solution shall be approved;^P

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 (FIFRA),^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

12VAC5-421-1920. Laundering frequency for linens, cloth gloves, napkins, and wiping cloths.

A. Linens that do not come in direct contact with food shall be laundered between operations if they become wet, sticky, or visibly soiled.

B. Cloth gloves used as specified in 12VAC5-421-580 D shall be laundered before being used with a different type of raw animal food such as beef, fish, lamb, pork, and fish poultry.

C. Linens and napkins that are used as specified under 12VAC5-421-560 and cloth napkins shall be laundered between each use.

D. Wet wiping cloths shall be laundered daily.

E. Dry wiping cloths shall be laundered as necessary to prevent contamination of food and clean serving utensils.

12VAC5-421-2090. Nonpotable water.

A. A nonpotable water supply shall be used only if its use is approved by the regulatory authority department.^P

B. Nonpotable water shall be used only for nonculinary purposes such as air conditioning, nonfood equipment cooling, and fire protection, and irrigation.^P

12VAC5-421-2100. Sampling.

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

1. If nitrate, which is reported as "N" on the test results, exceeds 10 mg/L (ppm), the owner shall notify the regulatory authority department within 24 hours from when the owner is notified of the nitrate positive test result.^Pf

2. If a sample is total coliform positive, the positive culture medium shall be further analyzed to determine if E. coli is present. The owner shall notify the regulatory authority department within two calendar days from when the owner is notified of the coliform positive test result.^Pf

3. If E. coli is present, the owner shall notify the regulatory authority department within 24 hours from when the owner is notified of the E. coli positive test result.^Pf

12VAC5-421-2110. Sample report.

All sample reports for the private well shall be retained on file in the food establishment for a minimum of five years and be made available to the regulatory authority department upon request.

12VAC5-421-2140. [Reserved] Water System.

Water shall be received from the source through the use of:

1. An approved public water main;^Pf or

2. One or more of the following that shall be constructed, maintained, and operated according to law: ^Pf

a. Nonpublic water main, water pumps, pipes, hoses, connections, and other appurtenances;^Pf

b. Water transport vehicles;^Pf or

c. Water containers.^Pf

12VAC5-421-2270. Backflow prevention device, carbonator.

A. If not provided with an air gap as specified under 12VAC5-421-2200, a double dual check valve with an intermediate vent preceded by a screen of not less than 100 mesh to 1 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 approved provided as specified under subsection A of this section.

12VAC5-421-2330. Scheduling inspection and service for a water system device.

A device such as a water treatment device or backflow preventer shall be scheduled for inspection and service, in accordance with manufacturer's instructions and as necessary to prevent device failure based on local water conditions, and records demonstrating inspection and service shall be maintained by the person in charge for a minimum of five years and made available to the department upon request.^Pf

12VAC5-421-2350. System maintained in good repair.

A plumbing system shall be (i) repaired:

1. Repaired according to law;^P and (ii) maintained

2. Maintained in good repair.

12VAC5-421-2505. Establishment drainage system.

Food establishment drainage systems, including grease traps, that convey sewage shall be designed and installed as specified under 12VAC5-421-2180 A.

12VAC5-421-2570. Approved sewage disposal system.

Sewage shall be disposed through an approved facility that is:

1. A public sewage treatment plant;^P or

2. An individual sewage disposal system that is sized, constructed, maintained, and operated according to the State Board of Health's regulations promulgated pursuant to Chapter 6 (§ 32.1-163 et seq.) of Title 32 of the Code of Virginia, including 12VAC5-610, Sewage Handling and Disposal Regulations, 12VAC5-613, and 12VAC5-640 Regulations for Alternative Onsite Sewage Systems, or otherwise according to law.^P

12VAC5-421-2720. Covering receptacles.

1. Inside the food establishment if the receptacles and units (i) contain:

a. Contain food residue and are not in continuous use; or (ii) after

b. After they are filled; and

2. With tight-fitting lids or doors if kept outside the food establishment.

12VAC5-421-2750. 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 12VAC5-421-2550 12VAC5-421-2540.

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.

12VAC5-421-3040. Handwashing aids and devices, use restrictions.

A sink used for food preparation or utensil washing, or a service sink or curbed cleaning facility used for the disposal of mop water or similar wastes, shall not be provided with the handwashing aids and devices required for a handwashing sink as specified under 12VAC5-421-3020 and, 12VAC5-421-3030, and 12VAC5-421-2650 C.

12VAC5-421-3310. Prohibiting animals.

A. Except as specified in subsections B and C of this section, live animals shall not be allowed on the premises of a food establishment.^Pf

B. Live animals may be allowed in the following situations if the contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result:

1. Edible fish or decorative fish in aquariums, shellfish or crustacea on ice or under refrigeration, and shellfish and crustacea in display tank systems;

2. Patrol dogs accompanying police or security officers in offices and dining, sales, and storage areas, and sentry dogs running loose in outside fenced areas;

3. In areas that are not used for food preparation and that are usually open for customers, such as dining and sales areas, service animals that are controlled by the disabled employee or person if a health or safety hazard will not result from the presence or activities of the service animal;

4. Pets in the common dining areas of institutional care facilities such as nursing homes, assisted living facilities, group homes, residential care facilities, and bed and breakfast operations at times other than during meals if:

a. Effective partitioning and self-closing doors separate the common dining areas from food storage or food preparation areas;

b. Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining areas when pets are present; and

c. Dining areas including tables, countertops, and similar surfaces are effectively cleaned before the next meal service;

5. In areas that are not used for food preparation, storage, sales, display, or dining, in which there are caged animals or animals that are similarly restricted, such as in a variety store that sells pets or a tourist park that displays animals; and

6. Dogs in outdoor dining areas if:

a. The outdoor dining area is not fully enclosed with floor to ceiling walls and is not considered a part of the interior physical facility.;

b. The outdoor dining area is equipped with an entrance that is separate from the main entrance to the food establishment and the separate entrance serves as the sole means of entry for patrons accompanied by dogs.;

c. A sign stating that dogs are allowed in the outdoor dining area is posted at each entrance to the outdoor dining area in such a manner as to be clearly observable by the public.;

d. A sign within the outdoor dining area stating the requirements as specified in subdivisions 6 e, 6 f, and 6 g of this subsection is provided in such a manner as to be clearly observable by the public.;

e. Food and water provided to dogs is served using equipment that is not used for service of food to persons or is served in single-use articles.;

f. Dogs are not allowed on chairs, seats, benches, or tables.;

g. Dogs are kept on a leash or within a pet carrier and under the control of an adult at all times.; and

h. Establishment provides effective means for cleaning up dog vomitus and fecal matter.

C. Live or dead fish bait may be stored if contamination of food; clean equipment, utensils, and linens; and unwrapped single-service and single-use articles cannot result.

D. In bed and breakfast operations serving 18 or fewer guests, live animals shall be allowed in the facility but shall not be fed using the same equipment or utensils that are used to feed humans.

12VAC5-421-3360. Conditions of use.

Poisonous or toxic materials shall be:

1. Used according to:

a. Law and this chapter;

b. Manufacturer's use directions included in labeling, and, for a pesticide, manufacturer's label instructions that state that use is allowed in a food establishment;^P

c. The conditions of certification, if certification is required, for use of the pest control materials;^P and

d. Additional conditions that may be established by the regulatory authority.^P department; and

2. Applied so that:

a. A hazard to employees or other persons is not constituted;^P and

b. Contamination including toxic residues due to drip, drain, fog, splash, or spray on food, equipment, utensils, linens, and single-service and single-use articles is prevented, and for a restricted-use pesticide, this is achieved by:^P

(1) Removing the items, covering;^P

(2) Covering the items with impermeable covers,;^P or taking

(3) Taking other appropriate preventive actions;^P and

(2) (4) Cleaning and sanitizing equipment and utensils after the application.^P

A restricted use pesticide shall be applied only by an applicator certified as defined in 7 USC § 136(e) (Federal Insecticide, Fungicide and Rodenticide Act), or a person under the direct supervision of a certified applicator.^Pf

12VAC5-421-3390. Chemicals for washing, treatment, storage, 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:

1. Be an approved food additive listed for this intended use in 21 CFR Part 173,;^P or

2. Be generally recognized as safe (GRAS) 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 and

4. Meet the requirements in the 40 CFR Part 156.^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

12VAC5-421-3410. Drying agents, criteria.

Drying agents used in conjunction with sanitization shall:

1. Contain only components that are listed as one of the following:

a. Generally recognized as safe (GRAS) for use in food as specified in 21 CFR Part 182 or 21 CFR Part 184,^P

b. Generally recognized as safe GRAS for the intended use as specified in 21 CFR Part 186,^P

c. Generally recognized as safe GRAS for the intended use as determined by experts qualified in scientific training and experience to evaluate the safety of substances added, directly or indirectly, to food as described in 21 CFR 170.30, ^P

d. Subject of an effective Food Contact Notification as described in the Federal Food Drug and Cosmetic Act (FFDCA) § 409(h),^P

e. Approved for use as a drying agent under a prior sanction specified in 21 CFR Part 181 as specified in the Federal Food Drug and Cosmetic Act (FFDCA) § 201(s)(4),^P

f. Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 CFR Parts 175 174 through 178,^P or

g. Approved for use as a drying agent under the threshold of regulation process established by 21 CFR 170.39;^P and

2. When sanitization is with chemicals, the approval required under subdivision 1 e or g of this section or the regulation as an indirect food additive required under subdivision 1 f of this section, shall be specifically for use with chemical sanitizing solutions.^P

12VAC5-421-3510. Public health protection.

A. The regulatory authority department shall apply this regulation chapter to promote its underlying purpose, as specified in 12VAC5-421-30, of safeguarding public health and ensuring that food is safe and, unadulterated and honestly presented when offered to the consumer.

B. In enforcing the provisions of this regulation, the regulatory authority department shall assess existing facilities or equipment that were in use before March 1, 2002 June 10, 2021, 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 12VAC5-421-960 through 12VAC5-421-1060; and

3. Whether the capacities of cooling, heating, and holding equipment are sufficient to comply with 12VAC5-421-1450.

12VAC5-421-3520. Preventing health hazards, provision for conditions not addressed.

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

B. The regulatory authority 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 permit applicant or permit holder and a copy shall be maintained in the regulatory authority's department's file for the food establishment.

12VAC5-421-3550. Food Service Advisory Committee. (Repealed.)

The commissioner shall appoint a Food Service Advisory Committee (FSAC). He shall appoint to the FSAC as many members as he wishes, but a minimum of one individual each from the following: Department of Agriculture and Consumer Services, Department of Housing and Community Development, Department of Social Services, Virginia Hospitality and Travel Association, Virginia Retail Merchants Association, public at large, Virginia Public Health Association, Virginia Environmental Health Association, Virginia Caterers Association, Virginia Food Dealers Association, a consumer and/or civic organization representative, and an environmental health specialist.

Ex-officio members shall be the Director of the Division of Food and General Environmental Services and the Director of Health Facilities Regulation.

Appointed members of the FSAC shall serve at the discretion of the commissioner and shall make recommendation to the commissioner regarding food service policies, procedures and other food program operations. The FSAC shall meet at least annually.

12VAC5-421-3560. Exemptions to regulations. (Repealed.)

A. The following are exempt from this chapter as defined in §§ 35.1-25 and 35.1-26 of the Code of Virginia.

1. Boarding houses that do not accommodate transients;

2. Cafeterias operated by industrial plants for employees only;

3. Churches, fraternal, school and social organizations and volunteer fire departments and rescue squads which hold dinners and bazaars of not more than one time per week and not in excess of two days duration at which food prepared in homes of members or in the kitchen of the church or organization and is offered for sale to the public;

4. Grocery stores, including the delicatessen that is a part of a grocery store, selling exclusively for off-premises consumption and places manufacturing or selling packaged or canned goods;

5. Churches that serve meals for their members as a regular part of their religious observance;

6. Convenience stores or gas stations that are subject to the State Board of Agriculture and Consumer Services' Retail Food Establishment Regulations (2VAC5-585) or any regulations subsequently adopted and that (i) have 15 or fewer seats at which food is served to the public on the premises of the convenience store or gas station and (ii) are not associated with a national or regional restaurant chain. Notwithstanding this exemption, such convenience stores or gas stations shall remain responsible for collecting any applicable local meals tax; and

7. Any bed and breakfast operation that prepares food for and offers food to guests, regardless of the time the food is prepared and offered, if (i) the premises of the bed and breakfast operation is a home that is owner occupied or owner-agent occupied, (ii) the bed and breakfast operation prepares food for and offers food to transient guests of the bed and breakfast only, (iii) the number of guests served by the bed and breakfast operation does not exceed 18 on any single day, and (iv) guests for whom food is prepared and to whom food is offered are informed by statements contained in published advertisements, mailed brochures, and placards posted at the registration area that the food is prepared in a kitchen that is not licensed as a restaurant and is not subject to regulations governing restaurants.

B. The governing body of any county, city or town may provide by ordinance that this chapter shall not apply to food booths at fairs and youth athletic activities if such booths are promoted or sponsored by any political subdivision of the Commonwealth or by any charitable nonprofit organization or group thereof. The ordinance shall provide that the director of the county, city, or town in which the fair and youth athletic activities are held, or a qualified person designated by the director, shall exercise such supervision of the sale of food as the ordinance may prescribe.

12VAC5-421-3570. Variances.

A. The commissioner or his designee may grant a variance to this chapter by following the appropriate procedures set forth in this section and 12VAC5-421-3580.

B. The commissioner or the commissioner's designee may grant a variance if he finds that the hardship imposed, which may be economic, outweighs the benefits that may be received by the public and that granting such a variance does not subject the public to unreasonable health risks or environmental pollution.

C. Any owner or permit holder who seeks a variance shall apply in writing within the time period specified in 12VAC5-421-4000. The request should shall be sent to the local health department. The application shall include:

1. A citation to the regulation from which a variance is requested;

2. The nature and duration of the variance requested;

3. Any relevant analytical results including result of relevant tests conducted pursuant to the requirements of these regulations;

4. Statements or evidence which establishes that the public health, welfare and environment would not be adversely affected if the variance were granted;

5. Suggested conditions that might be imposed on the granting of a variance that would limit the detrimental impact on the public health and welfare;

6. A HACCP plan if required as specified under 12VAC5-421-3620 A that includes the information specified under 12VAC5-421-3630 as it is relevant to the variance requested.

7. Other information believed pertinent by the applicant; and

8. Such other information as the district or local health department or commissioner may require.

12VAC5-421-3580. Evaluation of a variance application.

A. The commissioner shall act on any variance request submitted pursuant to 12VAC5-421-3570 B C within 60 days of receipt of the request.

B. In evaluating a variance application, the commissioner shall consider such factors as the following:

1. The effect that such a variance would have on the operation of the food establishment.

2. The cost and other economic considerations imposed by this requirement;

3. The effect that such a variance would have on protection of the public health, safety, welfare and the environment;

4. Such other factors as the commissioner, deputy commissioner, or director of the office of environmental health services may deem appropriate.

12VAC5-421-3595. Conformance with approved procedures.

If the commissioner or the commissioner's designee grants a variance as specified in 12VAC5-421-3570, or a HACCP plan is otherwise required as specified under 12VAC5-421-3620, the permit holder shall:

1. Comply with the HACCP plans and procedures that are submitted as specified under 12VAC5-421-3630 and approved as a basis for the variance;^P and

2. Maintain and provide to the department, upon request, records specified under subdivisions 4 and 5 c of 12VAC5-421-3630 that demonstrate that the following are routinely employed:

a. Procedures for monitoring the critical control points;^PF

b. Monitoring of the critical control points;^PF

c. Verification of the effectiveness of the operation or process;^PF and

d. Necessary corrective actions if there is failure at the critical control point. ^PF

12VAC5-421-3600. Facility and operating plans.

A permit applicant or permit holder shall submit to the regulatory authority department properly prepared plans and specifications for review and approval before:

1. The construction of a food establishment;^Pf

2. The conversion of an existing structure for use as a food establishment;^Pf or

3. The remodeling of a food establishment or a change of type of food establishment or food operation as specified under subdivision 3 of 12VAC-421-3700 12VAC5-421-3700 if the regulatory authority department determines that plans and specifications are necessary to ensure compliance with this chapter.^Pf

12VAC5-421-3610. Contents of the plans and specifications.

The plans and specifications for a food establishment, including a food establishment specified under 12VAC5-421-3620, shall include, as required by the regulatory authority department based on the type of operation, type of food preparation, and foods prepared, the following information to demonstrate conformance with the provisions of this chapter:

1. Intended menu;

2. Anticipated volume of food to be stored, prepared, and sold or served;

3. Proposed layout, mechanical schematics, construction materials, and finish schedules;

4. Proposed equipment types, manufacturers, model numbers, locations, dimensions, performance capacities, and installation specifications;

5. Evidence that standard procedures ensuring compliance with the requirements of this chapter are developed or are being developed; and

6. Other information that may be required by the regulatory authority department for the proper review of the proposed construction, conversion or modification, and procedures for operating a food establishment.

12VAC5-421-3620. When a HACCP plan is required.

A. Before engaging in an activity that requires a HACCP plan, a permit applicant or permit holder shall submit to the regulatory authority department for approval a properly prepared HACCP plan as specified under 12VAC5-421-3630 and the relevant provisions of this chapter if:

1. Submission of a HACCP plan is required according to law;

2. A variance is required as specified under 12VAC5-421-700 D 4,12VAC5-421-860, or 12VAC5-421-1300 B, or 12VAC5-421-700 D 4; or

3. The regulatory authority department determines that a food preparation or processing method requires a variance based on a plan submittal specified under 12VAC5-421-3610, an inspectional finding, or a variance request.

B. Before engaging in reduced oxygen packaging without a variance as specified under 12VAC5-421-870, a permit applicant or permit holder shall submit a properly prepared HACCP plan to the regulatory authority. department.

12VAC5-421-3630. Contents of a HACCP plan.

For a food establishment that is required under 12VAC5-421-3620 to have a HACCP plan, the permit applicant or permit holder shall submit to the regulatory authority department a properly prepared HACCP plan that includes:

1. General information such as the name of the permit applicant or permit holder, the food establishment address, and contact information;^Pf

2. A categorization of the types of time/temperature control for safety food that is to be controlled under the HACCP plan;^Pf

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

a. Each step in the process,^Pf

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. Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved;.^Pf

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

a. Each critical control point;^Pf

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

c. The method and frequency for monitoring and controlling each critical control point by the food employee designated by 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 person in charge if the critical limits for each critical control point are not met;^Pf and

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

5. Supporting documents such as;:

a. Food employee and supervisory training plan addressing food safety issues;^Pf

b. Copies of blank records forms that are necessary to implement a the HACCP plan;^Pf

c. Additional scientific data or other information, as required by the regulatory authority department supporting the determination that food safety is not compromised by the proposal;^Pf and

6. Any other information required by the regulatory authority department.

12VAC5-421-3640. Confidentiality -- trade secrets.

The regulatory authority department shall treat as confidential in accordance with law, information that meets the criteria specified in law for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified under 12VAC5-421-3610 and 12VAC5-421-3630.

12VAC5-421-3650. Preoperational inspections.

The regulatory authority department shall conduct one or more preoperational inspections to verify that the food establishment is constructed and equipped in accordance with the approved plans and approved modifications of those plans, has established standard operating procedures as specified under subdivision 5 of 12VAC5-421-3610 and is in compliance with law and this chapter.

12VAC5-421-3660. Permits.

A. No person shall own, establish, conduct, maintain, manage, or operate any food establishment in this Commonwealth unless the food establishment is permitted as provided in this section. All permits shall be in the name of the owner or lessee. Permits shall not be issued to newly constructed or extensively remodeled food establishments until a certificate of occupancy has been issued by the Building Official. Only a person who complies with the requirements of this part shall be entitled to receive or retain such a permit.

B. Permits issued shall not be transferable from one person to another or from one location to another. A new owner shall be required to make a written application for a permit. The application forms are obtainable at all local health departments.

C. Any person operating a food establishment with a valid permit who desires to expand or modify the establishment, shall notify the director local health department in the jurisdiction where the food establishment is located, and the director local health department shall determine whether such expansion, modification, or reclassification is in compliance with the applicable sections of this chapter.

D. The permit shall be posted in every food establishment in a place where it is readily observable by the public transacting business with the establishment.

E. Permits shall expire annually otherwise not to exceed 12 months from the date of issuance.

12VAC5-421-3670. Application procedure, submission before proposed opening.

A. An applicant seeking to operate a nontemporary food establishment shall submit an application for a permit at least 30 calendar days before the date planned for opening a food establishment or at least 30 calendar days before the expiration date of the current permit for an existing facility.

B. An applicant seeking to operate a temporary food establishment shall submit an application for a permit at least 10 calendar days before the date planned for opening the temporary food establishment.

C. Any applicant who fails to complete the application process within 12 months of receipt of the application by the local health department's office may be required to submit a new application and plan.

12VAC5-421-3680. Form of submission.

A person desiring to operate a food establishment shall submit to the regulatory authority department a written application for a permit on a form provided by the regulatory authority. department.

12VAC5-421-3690. Qualifications and responsibilities of applicants.

To qualify for a permit, an applicant shall:

1. Be an owner of the food establishment or an officer of the legal ownership;

2. Comply with the requirements of this regulation chapter; and

3. As specified under 12VAC5-421-3820, agree to allow access to the food establishment and to provide required information.

12VAC5-421-3700. Contents of the application.

The application shall include:

1. The name, mailing address, telephone number, and signature of the person applying for the permit and the name, mailing address, and location of the food establishment;

2. Information specifying whether the food establishment is owned by an association, corporation, individual, partnership, or other legal entity;

3. A statement specifying whether the food establishment:

a. Is mobile or stationary, and temporary or permanent; and

b. Is an operation that includes one or more of the following:

(1) Prepares, offers for sale, or serves time/temperature control for safety food:

(a) Only to order upon a consumer's request;

(b) In advance in quantities based on projected consumer demand and discards food that is not sold or served at an approved frequency; or

(c) Using time as the public health control as specified under 12VAC5-421-850;

(2) Prepares time/temperature control for safety food in advance using a food preparation method that involves two or more steps which may include combining time/temperature control for safety food ingredients; cooking; cooling; reheating; hot or cold holding; freezing; or thawing;

(3) Prepares food as specified under subdivision 3 b (2) of this section for delivery to and consumption at a location off the premises of the food establishment where it is prepared;

(4) Prepares food as specified under subdivision 3 b (2) of this section for service to a highly susceptible population;

(5) Prepares only food that is not time/temperature control for safety food; or

(6) Does not prepare, but offers for sale only prepackaged food that is not time/temperature control for safety food;

4. The name, title, address, and telephone number of the person directly responsible for the food establishment;

5. The name, title, address, and telephone number of the person who functions as the immediate supervisor of the person specified under subdivision 4 of this section such as the zone, district, or regional supervisor;

6. The names, titles, and addresses of:

a. The persons comprising the legal ownership as specified under subdivision 2 of this section including the owners and officers; and

b. The local resident agent if one is required based on the type of legal ownership;

7. A statement signed by the applicant that:

a. Attests to the accuracy of the information provided in the application; and

b. Affirms that the applicant will:

(1) Comply with this chapter; and

(2) Allow the regulatory authority department access to the establishment as specified under 12VAC5-421-3820 and to the records specified under 12VAC5-421-440 and 12VAC5-421-2330 and subdivision 4 of 12VAC5-421-3630; and

8. Other information required by the regulatory authority. department.

12VAC5-421-3710. New, converted, or remodeled establishments.

For food establishments that are required to submit plans as specified under 12VAC5-421-3600 the regulatory authority department shall issue a permit to the applicant after:

1. A properly completed application is submitted;

2. Any required fee is submitted;

3. The required plans, specifications, and information are reviewed and approved; and

4. A preoperational inspection as specified in 12VAC5-421-3650 shows that the establishment is built or remodeled in accordance with the approved plans and specifications and that the establishment is in compliance with this chapter.

12VAC5-421-3720. Existing establishments, permit renewal, and change of ownership, or termination.

A. The regulatory authority department may renew a permit for an existing food establishment or may issue a permit to a new owner of an existing food establishment after a properly completed application is submitted, reviewed, and approved, any fees are paid, and an inspection shows that the establishment is in compliance with this chapter.

B. An existing food establishment shall notify the department in writing of a change of legal ownership or when business operations have terminated. Such notice shall be submitted in writing to the department at least 30 days prior to the legal ownership transfer or termination of business operation.

12VAC5-421-3730. Denial of application for permit, notice.

If an application for a permit to operate is denied, the regulatory authority department shall provide the applicant with a notice that includes:

1. The specific reasons and chapter citations for the permit denial;

2. The actions, if any, that the applicant must take to qualify for a permit; and

3. Advisement of the applicant's right of appeal and the process and time frames for appeal that are provided in law.

12VAC5-421-3740. Responsibilities of the regulatory authority department.

A. At the time a permit is first issued, the regulatory authority department shall provide to the permit holder a copy (or opportunity to obtain a copy) of this chapter so that the permit holder is notified of the compliance requirements and the conditions of retention, as specified under 12VAC5-421-3750, that are applicable to the permit.

B. Failure to provide the information specified in subsection A of this section does not prevent the regulatory authority department from taking authorized action or seeking remedies if the permit holder fails to comply with this chapter or an order, warning, or directive of the regulatory authority department.

12VAC5-421-3750. Responsibilities of the permit holder.

Upon acceptance of the permit issued In order to retain a permit issued by the regulatory authority department, the permit holder in order to retain the permit shall:

1. Post the permit in a location in the food establishment that is conspicuous to consumers;

2. Comply with the provisions of this chapter including the conditions of a granted variance as specified under 12VAC5-421-3590 and 12VAC5-421-3595, and approved plans as specified under 12VAC5-421-3610;

3. If a food establishment is required under 12VAC5-421-3620 to operate under a HACCP plan, comply with the plan as specified under 12VAC5-421-3590 12VAC5-421-3595;

4. Immediately contact the regulatory authority department to report an illness of a food employee or conditional employee as specified under 12VAC5-421-80 B;

5. Immediately discontinue operations and notify the regulatory authority department if an imminent health hazard may exist as specified under 12VAC5-421-3910;

6. Allow representatives of the regulatory authority department access to the food establishment as specified under 12VAC5-421-3820;

7. Replace existing facilities and equipment specified in 12VAC5-421-3510 with facilities and equipment that comply with this chapter if:

a. The regulatory authority 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 regulatory authority 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;

8. Comply with directives of the regulatory authority department including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the regulatory authority department in regard to the permit holder's food establishment or in response to community emergencies;

9. Accept notices issued and served by the regulatory authority department according to law; and

10. 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 regulatory authority department, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives.

11. Notify customers that a copy of the most recent establishment inspection report is available upon request by:

a. Posting a sign or placard in a location in the food establishment that is conspicuous to customers; or

b. By another method acceptable to the department.

12VAC5-421-3770. Summary suspension of a permit.

The director may summarily suspend a permit to operate a restaurant food establishment if the director finds the continued operation constitutes a substantial and imminent threat to the public health, except the director may summarily suspend the permit of a temporary restaurant as addressed under 12VAC5-421-3870. Upon receipt of such notice that a permit is suspended, the permit holder shall cease food operations immediately and begin corrective action.

Whenever a permit is suspended, the holder of the permit or the person in charge shall be notified in writing by certified mail or by hand delivery. Upon service receipt of notice that the permit is immediately suspended, the former permit holder shall be given an opportunity for an informal fact-finding conference in accordance with § 2.2-4019 of the Code of Virginia. The request for an informal fact-finding conference shall be in writing. The written request shall be filed with the local department by the former holder of the permit. If written request for an informal fact-finding conference is not filed within 10 working days, the suspension is sustained. Each holder of a suspended permit shall be afforded an opportunity for an informal fact-finding conference, within three working days of receipt of a request for the informal fact-finding conference. The director may end the suspension at any time if the reasons for the suspension no longer exist.

12VAC5-421-3780. Revocation of a permit.

The director may, after providing an opportunity for conducting an informal fact-finding conference in accordance with § 2.2-4019 of the Code of Virginia, revoke a permit for flagrant or continuing violation of any of the requirements of this part.

12VAC5-421-3800. Periodic inspection.

Food establishments shall be inspected by the designee of the director department. Inspections of the food establishments shall be performed as often as necessary for the enforcement of this part chapter in accordance with the following:

1. Except as specified in subdivisions 2 and 3 of this section, the regulatory authority department shall inspect a food establishment at least once every six months.

2. The regulatory authority department may increase the interval between inspections beyond six months if:

a. The food establishment is fully operating under an approved and validated HACCP plan as specified under 12VAC5-421-3595 and 12VAC5-421-3630;

b. The food establishment is assigned a less frequent inspection frequency based on an established risk-based inspection schedule uniformly applied throughout the Commonwealth and updated annually upon reissuance of the annual permit; or

c. 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.

3. The regulatory authority department shall inspect a temporary food establishment during its permit period, unless the Virginia Department of Health department develops a written risk-based plan for adjusting the frequency of inspections of temporary food establishments that is uniformly applied throughout the Commonwealth.

12VAC5-421-3810. Performance-based and risk-based inspections.

Within the parameters specified in 12VAC5-421-3800, the regulatory authority department shall prioritize, and conduct the conducting of more frequent inspections based upon its assessment of a food establishment's history of compliance with this chapter and the establishment's potential as a vector of foodborne illness by evaluating:

1. Past performance for nonconformance with this chapter or HACCP plan requirements that are priority items or priority foundation items;

2. Past performance for numerous or repeat violations of this chapter or HACCP plan requirements that are core items;

3. Past performance for complaints investigated and found to be valid;

4. The hazards associated with the particular foods that are prepared, stored, or served;

5. The type of operation including the methods and extent of food storage, preparation, and service;

6. The number of people served; and

7. Whether the population served is a highly susceptible population.

12VAC5-421-3815. Competency of environmental health specialists.

A. An authorized representative of the commissioner who inspects a food establishment or conducts plan review for compliance with this chapter shall have the knowledge, skills, and ability to adequately perform the required duties. For the purposes of this section, competency shall be demonstrated when an environmental health specialist meets the training and standardization requirements specified in the Virginia Department of Health Procedures for Certification and Standardization of Retail Food Protection Staff, 2014, (VDH, Division of Food and Environmental Services) as determined by the department.

B. The regulatory authority 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 this chapter.

12VAC5-421-3820. Access allowed at reasonable times after due notice.

After the regulatory authority department presents official credentials and provides notice of the purpose of, and an intent to conduct, an inspection, the person in charge shall allow the regulatory authority department 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 regulatory authority department is entitled according to law, during the food establishment's hours of operation and other reasonable times.

12VAC5-421-3830. Refusal, notification of right to access, and final request for access.

If a person denies access to the regulatory authority department, the regulatory authority department shall:

1. Inform the person that:

a. The permit holder is required to allow access to the regulatory authority department as specified under 12VAC5-421-3820,

b. Access is a condition of the acceptance and retention of a food establishment permit to operate as specified under subdivision 6 of 12VAC5-421-3750 F, and

c. If access is denied, the commissioner or his designee may apply to an appropriate circuit court for an inspection warrant authorizing such inspection, testing, or taking samples for testing as provided in Chapter 24 (§ 19.2-393 et seq.) of Title 19.2 of the Code of Virginia; and

2. Make a final request for access.

12VAC5-421-3840. Refusal, reporting.

If after the regulatory authority department presents credentials and provides notice as specified under 12VAC5-421-3820, explains the authority upon which access is requested, and makes a final request for access as specified in 12VAC5-421-3830, the person in charge continues to refuse access, the regulatory authority department shall provide details of the denial of access on an inspection report form.

12VAC5-421-3860. Documenting information and observations.

The regulatory authority department 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 as specified under 12VAC5-421-3700, inspection date, and other information such as type of water supply and sewage disposal, status of the permit, 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 permit holder 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 12VAC5-421-60;

b. Failure of food employees, conditional employees, and the person in charge to report a disease or medical condition as specified under 12VAC5-421-80 B and D;

c. Nonconformance with priority items or, priority foundation, or core 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 regulatory authority department as specified under 12VAC5-421-60;

e. Failure of the person in charge to provide records required by the regulatory authority department for determining conformance with a HACCP plan as specified under subdivision 4 f of 12VAC5-421-3630; and

f. Nonconformance with critical limits of a HACCP plan.

12VAC5-421-3870. Specifying time frame for corrections.

The regulatory authority department shall specify on the inspection report form the time frame for correction of the violations as specified under 12VAC5-421-3910, 12VAC5-421-3930, and 12VAC5-421-3950. In the case of temporary food establishments, all violations shall be corrected within a maximum of 24 hours or the permit shall be suspended. The establishment shall immediately cease food service operations until authorized to resume by the director.

12VAC5-421-3880. Issuing report and obtaining acknowledgment of receipt.

At the conclusion of the inspection and according to law, the regulatory authority department shall provide a copy of the completed inspection report and the notice to correct violations to the permit holder or to the person in charge, and request a signed acknowledgment of receipt.

12VAC5-421-3890. Refusal to sign acknowledgment.

The regulatory authority department shall:

1. Inform a person who declines to sign an acknowledgment of receipt of inspectional findings as specified in 12VAC5-421-3880 that:

a. An acknowledgment of receipt is not an agreement with findings,

b. Refusal to sign an acknowledgment of receipt will not affect the permit holder's obligation to correct the violations noted in the inspection report within the time frames specified, and

c. A refusal to sign an acknowledgment of receipt is noted in the inspection report and conveyed to the regulatory authority's department's historical record for the food establishment; and

2. Make a final request that the person in charge sign an acknowledgment receipt of inspectional findings.

12VAC5-421-3900. Public records.

Except as specified in 12VAC5-421-3640, the regulatory authority department shall treat the inspection report as a public record and shall make it available for disclosure to a person who requests it as provided in law.

12VAC5-421-3910. Imminent health hazard, ceasing operations and reporting.

A. Except as specified in subsection subsections B and C of this section, a permit holder shall immediately discontinue operations and notify the regulatory authority 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. A permit holder 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.

12VAC5-421-3920. Resumption of operations.

If operations are discontinued as specified under 12VAC5-421-3910 or otherwise according to law, the permit holder shall obtain approval from the regulatory authority department before resuming operations.

12VAC5-421-3930. Timely correction.

A. Except as specified in subsection B of this section, a permit holder shall at the time of inspection correct a priority item or priority foundation item in this chapter and implement corrective actions for a HACCP plan provision that is not in compliance with its critical limit. ^Pf

B. Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the regulatory authority department may agree to or specify a longer timeframe, not to exceed:

1. 72 hours after the inspection for the permit holder to correct priority items; or

2. 10 calendar days after the inspection for the permit holder to correct priority foundation items or HACCP plan deviations.

C. In the case of temporary food establishments, priority items shall be corrected within a maximum of 24 hours after inspection.

12VAC5-421-3940. Verification and documentation of correction.

A. After observing at the time of inspection a correction of a priority item or, priority foundation item, or a HACCP plan deviation, the regulatory authority department shall enter the observation and information about the corrective action on the inspection report.

B. As specified under 12VAC5-421-3930 B, after receiving notification that the permit holder has corrected a priority item, or priority foundation item, or a HACCP plan deviation, or at the end of the specified period of time, the regulatory authority department shall verify correction, document the information on an inspection report, and enter the report in the regulatory authority's department records.

12VAC5-421-3950. Core item, timeframe for correction.

A. Except as specified in subsection B of this section, the permit holder shall correct core items by a date and time agreed to or specified by the regulatory authority department but no later than 90 calendar days after the inspection.

B. The regulatory authority department may approve a compliance schedule that extends beyond the time limits specified under subsection A of this section if a written schedule of compliance is submitted by the permit holder and no health hazard exists or will result from allowing an extended schedule for compliance.

12VAC5-421-3960. Examination for condemnation of food. (Repealed.)

Food may be examined or sampled by the department as often as necessary for enforcement of this chapter. Also, the department may, upon written notice to the owner or permit holder or person in charge impound any food which it believes is in violation of Part III (12VAC5-421-260 et seq.) or any other section of this chapter. The department shall tag, label, or otherwise identify any food subject to impoundment. No food under conditions specified in the impoundment shall be used, served or moved from the establishment. The department shall permit storage of the food under conditions specified in the impoundment unless storage is not possible without risk to the public health in which case immediate destruction shall be accomplished by the owner or permit holder or person in charge. The impoundment shall state that a request for an informal fact-finding conference may be filed within 10 days and that if no conference is requested, the food shall be destroyed by the owner or permit holder or person in charge. The department shall hold an informal fact-finding conference if so requested, and on the basis of evidence produced at the hearing, the impoundment may be vacated, or the owner or permit holder or person in charge of the food may be directed in writing by the director to denature or destroy such food or to bring it into compliance with the provisions of this chapter.

12VAC5-421-3961. Hold order, justifying conditions, and removal of food.

Upon written notice to the owner, permit holder, or person in charge, the department may place a hold order on food that:

1. Originated from an unapproved source;

2. May be unsafe, adulterated, or not honestly presented; or

3. Is not otherwise in compliance with this chapter.

12VAC5-421-3962. Hold order, contents.

The hold order notice shall:

1. State food subject to the order may not be used, sold, moved from the food establishment, or destroyed without a written release of the order from the department;

2. State the specific reasons for placing the food under the hold order with reference to the applicable provisions of this chapter and the hazard or adverse effect created by the observed condition;

3. Sufficiently identify the food subject to the hold order by the common name, the label information, a container description, quantity, department's tag or identification information, and location; and

4. Notify the permit holder of the right to request an informal fact-finding conference pursuant to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) within 10 calendar days of receipt of the hold order notice. Otherwise, the food under the hold order shall be destroyed by the owner, permit holder, or the person in charge.

12VAC5-421-3963. Hold order, official tagging of food.

A. The department shall securely place an official tag or label on the food or containers or otherwise conspicuously identity food subject to the hold order.

B. The tag or label used to identify a food subject to a hold order shall include a summary of the provisions specified in 12VAC5-421-3962 and shall be signed and dated by the department.

C. Only the department may remove hold order tags, labels, or other identification from food subject to a hold order.

12VAC5-421-3964. Hold order, food may not be used or moved.

A. Except as specified in subsection B of this section, food placed under a hold order may not be used, sold, served, or moved from the food establishment.

B. The department may allow the permit holder to store the food in an area of the food establishment if the food is protected from subsequent deterioration.

12VAC5-421-3965. Appeals, releasing hold order.

A. Any appeal of a hold order must be made in writing and received by the department within 10 calendar days of receipt of the hold order.

B. The department shall issue a notice of release from a hold order and shall remove hold tags, labels, or other identification from the food if the hold order is lifted.

12VAC5-421-3966. Destroying or denaturing food.

The department may order the permit holder to bring food under a hold order into compliance with this chapter or to destroy or denature food if:

1. Following an informal fact-finding conference held pursuant to the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia) the director affirms the hold order; or

2. The permit holder fails to file an appeal within 10 calendar days of receipt of the hold order notice.

12VAC5-421-3970. Enforcement of regulation.

A. This chapter shall be enforced by the State Board of Health and the State Health Commissioner, as executive officer of the board.

B. A. The directors are appointed by the board and commissioner as duly designated officers and are department is responsible for the implementation and enforcement of this chapter.

C. All food establishments shall operate in compliance with the requirements set forth in this chapter and shall not operate without a valid permit.

D. The commissioner shall be vested with all the authority of the board when it is not in session, subject to such rules and regulations as may be prescribed by the board.

E. B Pursuant to the authority granted in §§ 32.1-26 and 35.1-6 of the Code of Virginia, the commissioner may issue orders to require any owner or permit holder or other person to comply with the provisions of this chapter. The order may require the following:

1. The immediate cessation and correction of the violation;

2. Appropriate remedial action to ensure that the violation does not continue or recur;

3. The submission of a plan to prevent future violations;

4. The submission of an application for a variance; and

5. Any other corrective action deemed necessary for proper compliance with the regulations.

F. C. The commissioner may act as the agent of the board to enforce all effective orders and this chapter. Should any owner or permit holder fail to comply with any effective order or this chapter, the commissioner may:

1. Institute a proceeding to revoke the owner's or permit holder's permit in accordance with 12VAC5-421-3780;

2. Request the attorney for the Commonwealth to bring a criminal action;

3. Request the Attorney General to bring an action for civil penalty, injunction, or other appropriate remedy; or

4. Do any combination of the above.

G. Not exclusive means of enforcement. D. Nothing contained in this section shall be interpreted to require the commissioner to issue an order prior to seeking enforcement of any regulations or statute through an injunction, mandamus or criminal prosecution.

H. E. Proceedings before the commissioner or his designee shall include any of the following forms depending on the nature of the controversy and the interests of the parties involved.

1. Informal fact-finding conferences. An informal fact-finding conference is a meeting with a district or local health department with the district or local health director presiding and held in conformance with § 2.2-4019 of the Code of Virginia.

2. Adjudicatory hearing. The adjudicatory hearing is a formal, public adjudicatory proceeding before a hearing officer as defined by § 2.2-4001 of the Code of Virginia, and held in conformance with § 2.2-4020 of the Code of Virginia.

12VAC5-421-4010. Penalties, injunctions, civil penalties and charges for violations. (Repealed.)

1. Any person willfully violating, or refusing, failing, or neglecting to comply with any regulations or order of the board or commissioner, or any provision of this title, shall be guilty of a Class 3 misdemeanor unless a different penalty is specified. Each day of violation shall constitute a separate offense.

2. Any person violating, or failing, neglecting, or refusing to obey any order of the board or commissioner, or any provision of this part may be compelled, in a proceeding instituted in an appropriate court by the board or commissioner, to obey and comply with such regulations, order, or any applicable provision of Title 35.1 of the Code of Virginia. The proceeding may be by injunction, mandamus, or other appropriate remedy.

3. Without limiting the remedies which may be obtained pursuant to the above subsection, any person violating or failing, neglecting, or refusing to obey any injunction, mandamus, or other remedy obtained pursuant to the above subsection shall be subject, in the discretion of the court. to a civil penalty not to exceed ten thousand dollars for each violation. Each day of violation shall constitute a separate offense.

4. With the consent of any person who has violated or failed, neglected or refused to obey any regulation or order of the board or commissioner or any applicable provision of Title 35.1, the board may provide, in an order issued by the board against such person, for the payment of civil charges for past violations in specific sums not to exceed the limit set forth in the above subsection. Such civil charges shall be in place of any appropriate civil penalty which could be imposed under the above subsection.

12VAC5-421-4020. Compliance with the Uniform Statewide Building Code.

All buildings or structures utilized as restaurants food establishments constructed prior to. the effective date of the Virginia Uniform Statewide Building Code shall be maintained in conformance with the Virginia Fire Safety Law or other code in effect at the time of construction.

12VAC5-421-4035. Exempt facilities that choose to be regulated. (Repealed.)

Exempt facilities, as defined in subdivision 6 of 12VAC5-421-10 of the definition of a "food establishment" and subdivision A 7 of 12VAC5-421-3560, that choose to be regulated by this chapter, shall be exempt from the following requirements:

1. In lieu of 12VAC5-421-1200, home model dishwashers may be used in lieu of manual cleaning and drying of utensils;

2. 12VAC5-421-1340, the requirement for internal baffles in warewashing machines does not apply to home model dishwashers;

3. 12VAC5-421-1350, the requirement for temperature measuring devices does not apply to home model dishwashers;

4. 12VAC5-421-1360, manual warewashing equipment, heaters and baskets are not required but manual warewashing shall include, as a minimum, thorough washing with adequate soap or detergent, thorough rinsing, and drying before storage or use. Drying may be by clean towels used for no other purpose;

5. 12VAC5-421-1370, the requirement for a sanitizer level indicator does not apply to home model dishwashers;

6. 12VAC5-421-1380, the requirement for flow pressures device does not apply to home model dishwashers;

7. 12VAC5-421-1460, the requirement for sink compartments does not apply to exempt facilities. It shall include thorough washing with adequate soap or detergent, thorough rinsing, and drying before storage or use. Drying may be by clean towels used for no other purpose;

8. 12VAC5-421-1520, temperature measuring devices for manual warewashing are not required;

9. 12VAC5-421-1530, sanitizing solutions testing devices are not required;

10. 12VAC5-421-1620, warewashing sinks in exempt facilities may be used for handwashing, however, approved dispensers, soap, and single-use paper towels are provided;

11. 12VAC5-421-1640, clean solutions in warewashing equipment is not required for exempt facilities. It shall include, as a minimum, thorough washing with adequate soap or detergent, thorough rinsing, and drying before storage or use. Drying may be by clean towels used for no other purpose;

12. 12VAC5-421-1660, minimum wash solution temperature for mechanical warewashing equipment shall not be required for home model dishwashers;

13. 12VAC5-421-1670, minimum hot water sanitization temperatures for manual warewashing equipment shall not be required;

14. 12VAC5-421-1680, minimum hot water sanitization temperatures for mechanical warewashing equipment shall not be required for home model dishwashers;

15. 12VAC5-421-1690, sanitization pressure for mechanical warewashing equipment shall not be required;

16. 12VAC5-421-1700, minimum and maximum pressure, pH, sanitizer concentration, and hardness levels shall not be required for home model dishwashers;

17. 12VAC5-421-1710, chemical sanitization for manual warewashing using detergent sanitizers shall not be required;

18. 12VAC5-421-1720, determination of chemical sanitizer concentration shall not be required;

19. 12VAC5-421-1885, food-contact surfaces and utensils shall not be required to be sanitized;

20. 12VAC5-421-1890, before use after cleaning, utensils and food-contact surfaces shall not be required to be sanitized;

21. 12VAC5-421-1900, hot water and chemical sanitizing shall not be required;

22. 12VAC5-421-2790, floors, walls, and ceilings shall be in good repair and kept clean;

23, 12VAC5-421-2810, floors, walls, and ceilings in exempt facilities shall not be required to meet the cleanability requirements but shall be in good repair and kept clean;

24. 12VAC5-421-2820, the prohibition of exposed utility service lines and pipes shall not apply;

25. 12VAC5-421-2840, floor carpeting in exempt facilities may be installed in food preparation areas, walk-in refrigerators, warewashing areas, toilet rooms, refuse storage rooms or other areas, however they shall be kept in good repair and kept clean;

26. 12VAC5-421-2850, floor covering, mats and duckboards may be used in exempt facilities, however, they shall be kept clean and in good repair.

27. 12VAC5-421-2870, attachments to walls and ceilings in exempt facilities shall be kept in good repair and kept clean;

28. 12VAC5-421-3130, approved dispensers, soap and single-use paper towels shall be made available to accommodate hand washing;

29. 12VAC5-421-3310, live animals may be allowed in the facility but shall not be fed using the same equipment or utensils that are used to feed humans.

12VAC5-421-4040. Investigation and control, obtaining information: personal history of illness, medical examination, and specimen analysis.

The regulatory authority department shall act when it has reasonable cause to believe that a food employee or conditional employee has possibly transmitted disease; may be infected with a disease in a communicable form that is transmissible through food; may be a carrier of infectious agents that cause a disease that is transmissible through food; or is affected with a boil, an infected wound, or acute respiratory infection, by:

1. Securing a confidential medical history of the employee suspected of transmitting disease or making other investigations as deemed appropriate; and

2. Requiring appropriate medical examinations, including collection of specimens for laboratory analysis, of a suspected food employee and other employees or conditional employee.

12VAC5-421-4050. Restriction or exclusion of food employee, or summary suspension of permit.

Based on the findings of an investigation related to a food employee or conditional employee who is suspected of being infected or diseased, the regulatory authority department may issue an order to the suspected food employee, conditional employee, or permit holder instituting one or more of the following control measures:

1. Restricting the food employee or conditional employee;

2. Excluding the food employee or conditional employee; or

3. Closing the food establishment by summarily suspending a permit to operate in accordance with law.

12VAC5-421-4060. Restriction or exclusion order: warning or hearing not required, information required in order.

Based on the findings of the investigation as specified in 12VAC5-421-4040 and to control disease transmission, the regulatory authority department may issue an order of restriction or exclusion to a suspected food employee or the permit holder without prior warning, notice of a hearing, or a hearing if the order:

1. States the reasons for the restriction or exclusion that is ordered;

2. States the evidence that the food employee or permit holder shall provide in order to demonstrate that the reasons for the restriction or exclusion are eliminated;

3. States that the suspected food employee or the permit holder may request an appeal hearing by submitting a timely request as provided in law; and

4. Provides the name and address of the regulatory authority department representative to whom a request for an appeal hearing may be made.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-421)

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, 40th Edition, 2020, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of General Drugs

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

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

VDH Procedures for Certification and Standardization of Food Inspection Staff, 2017, Virginia Department of Health, Division of Food and Environmental Services, 109 Governor Street, 5th Floor, Richmond, VA 23219