TITLE 12. HEALTH

STATE BOARD OF HEALTH

Fast-Track Regulation

Title of Regulation: 12VAC5-421. Food Regulations (amending 12VAC5-421-3966, 12VAC5-421-3970).

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: December 18, 2024.

Effective Date: January 2, 2025.

Agency Contact: Olivia McCormick, Director, Division of Food and General Environment, Virginia Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8146, FAX (804) 864-7475, or email olivia.mccormick@vdh.virginia.gov.

Basis: Section 35.1-11 of the Code of Virginia requires the State Board of Health to make, adopt, promulgate, and enforce regulations necessary to protect the public health and safety, including the use of precautions to prevent the transmission of communicable diseases, hygiene, sanitation, safety, and physical plant management. Section 35.1-14 of the Code of Virginia authorizes the board to promulgate regulations that governing restaurants, including repealing or amending any regulation adopted pursuant to this subsection.

Purpose: The proposed changes are intended to clear up a potential inaccuracy with a document that is currently incorporated by reference in the regulatory text but should have been removed per a past regulatory action, so benefits the public by clarifying the regulation. The availability of more options for regulatory enforcement informal conferences and administrative efficiency ensures fair and expedient application of the regulation, which benefits the public welfare.

Rationale for Using Fast-Track Rulemaking Process: These changes are not expected to be controversial because expanding the options for a presiding officer for informal conferences is expected to provide greater expediency for a regulant and generally provides benefit to the public as Health Directors may be more involved in decisions without concern for a potential need for future recusal. Additionally, removing the document incorporated by reference (DIBR) is not controversial, as without reference to it in the regulation, it currently holds no force of administrative law and is only potentially confusing to the public.

Substance: The changes (i) update the requirements for who can preside over an informal conference or proceeding, (ii) clarify the allowance for the presiding officer to release impounded food after an informal conference, and (iii) remove a DIBR that has no corresponding reference in the text of the regulation.

Issues: Both changes provide advantages to the public and the agency. The presiding officer and impoundment release changes allow greater flexibility to both the agency and the public in scheduling informal conferences, potentially reducing the regulatory burden on citizens and businesses, and the DIBR removal eliminates confusion on the part of the public and agency staff as it is currently not in effect. There are no disadvantages to the public or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. The State Board of Health (board) proposes to amend the existing Food Regulations to (i) allow other representatives of the Virginia Department of Health (VDH), not just the local health director, to act as presiding officer over an informal conference or proceeding; (ii) allow presiding officers, not just the local health director, to affirm a hold order on food; and (iii) remove the name of a document from 12VAC5-421 Documents Incorporated by Reference that is not otherwise referenced in the text of the regulation.

Background. The Food Regulations establish minimum sanitary standards for the operation of the Commonwealth food establishments,² which include traditional restaurants, mobile food units, temporary food vendors, hospital and nursing facility food service, and school food service. Under the current regulation, only the local health director may preside over informal fact-finding conferences. The board proposes to amend the regulation so that other representatives of VDH may act as presiding officers. Upon written notice to the owner, permit holder, or person in charge, VDH may place a hold order on food that (i) originated from an unapproved source; (ii) may be unsafe, adulterated, or not honestly presented; or (iii) is not otherwise in compliance with the regulation. Food that is 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. Under the current regulation, VDH may direct that food under a hold order be brought into compliance with this regulation, or that the food be destroyed or denatured, if "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". The board proposes to change "director" to "department," so that representatives of the agency in addition to local health directors may act as the presiding officer who affirms the order. Pursuant to the Administrative Process Act (§ 2.2-4000 of the Code of Virginia), an agency may incorporate a document into the text of the regulation by, in part, including in the regulatory text the complete name of the document. When that occurs, the text of the document becomes part of the text of the regulation. Such a document is listed in the Documents Incorporated by Reference section of a regulation.

Estimated Benefits and Costs. According to VDH, the current approach of restricting the options for a presiding officer to one individual increases the chances of delay in scheduling. Additionally, at times, it may be best for local health directors to recuse themselves from presiding due to prior involvement in the case. Thus, allowing other representatives of VDH to act as presiding officers over informal fact-finding conferences, and to also affirm hold orders, may be beneficial. Additionally, according to the agency, "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," which is listed in 12VAC5-421-9999 Documents Incorporated by Reference but not otherwise referenced in the text of the regulation, should have been stricken in a prior regulatory action. The agency states that its inclusion is erroneous and misleading. Removing the name of this document from 12VAC5-421 may be beneficial in that it may reduce the possibility of confusion amongst readers of the regulation pertaining to its relevance.

Businesses and Other Entities Affected. The proposed amendments potentially affect approximately 31,000 permitted food establishments in the Commonwealth.³ The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁴ An adverse impact is indicated if there is any increase in net cost or reduction in net benefit for any entity, even if the benefits exceed the costs for all entities combined.⁵ As described, the proposed amendments neither increase costs nor reduce benefits for any entity. Thus, an adverse impact not indicated.

Small Businesses⁶ Affected.⁷ The proposed amendments do not appear to adversely affect small businesses.

Localities⁸ Affected.⁹ The proposed amendments neither disproportionally affect any particular localities nor directly affect costs for local governments.

Projected Impact on Employment. The proposed amendments are not likely to have a substantive impact on total employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to have a substantive impact on the use and value of private property and real estate development costs.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² The regulation defines food establishment as an operation that (i) stores, prepares, packages, serves, vends food directly to the consumer, or otherwise provides food for human consumption such as a market, restaurant, satellite or catered feeding location, catering operation if the operation provides food directly to a consumer or to a conveyance used to transport people, vending location, conveyance used to transport people, institution, or food bank and (ii) relinquishes possession of a food to a consumer directly, or indirectly through a delivery service such as home delivery of grocery orders or restaurant takeout orders, or delivery service that is provided by common carriers.

³ Data source: VDH.

⁴ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁵ Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation. As a result, DPB has adopted a definition of adverse impact that assesses changes in net costs and benefits for each affected Virginia entity that directly results from discretionary changes to the regulation.

⁶ Pursuant to § 2.2-4007.04, 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."

⁷ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

⁸ "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.

⁹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

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

Summary:

The amendments (i) update the requirements for who can preside over an informal conference or proceeding, (ii) clarify the allowance for the presiding officer to release impounded food after an informal conference, and (iii) remove a document incorporated by reference that has no corresponding reference in the text of the regulation.

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 department 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. The department is responsible for the implementation and enforcement of shall implement and enforce this chapter.

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 an 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 this chapter.

C. The commissioner may act as the agent of the board to enforce all effective orders and this chapter. Should any an 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 requirements listed in subdivisions 1, 2, or 3 of this subsection.

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.

E. Proceedings before the commissioner or his a designee shall include any of the following forms types depending on the nature of the controversy and the interests of the parties involved.:

1. Informal fact-finding conferences. An informal fact-finding conference proceeding, which is a meeting with a district or local health an informal conference between the department with the director presiding and the named party held in conformance accordance with § 2.2-4019 of the Code of Virginia.

2. Adjudicatory hearing. The An adjudicatory hearing, which 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.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-421)

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