TITLE 12. HEALTH

STATE BOARD OF HEALTH

Fast-Track Regulation

Title of Regulation: 12VAC5-421. Food Regulations (amending 12VAC5-421-3460).

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: July 16, 2025.

Effective Date: July 31, 2025.

Agency Contact: Kristin Marie Clay, Hearings and Legal Services Officer, Office of Environmental Health Services, Virginia Department of Health, 109 Governor Street, Fifth Floor, Richmond, VA 23219, telephone (804) 864-7474, or email kristin.clay@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 governing restaurants.

Purpose: The amendments allow (i) properly trained food establishment employees to act as a first line of response to serious medical emergencies where time is of the essence and remain in compliance with the regulatory standards pertaining to storage of medication on the premises of a restaurant and (ii) day care centers with a license to operate as a food establishment to store the medications of the children within their care. Current regulatory sections are in conflict and the amendments will resolve this issue while protecting the health, safety, or welfare of individuals who may have an anaphylactic reaction in a restaurant.

Rationale for Using Fast-Track Rulemaking Process: Chapter 853 of the 2020 Acts of Assembly authorizes any employee of a licensed restaurant to possess and administer epinephrine on the premises of a restaurant at which the employee is employed, provided that such employee is authorized by a prescriber and is trained in the administration of epinephrine. Without a regulatory amendment, the possession or storage of epinephrine on the premises of a food establishment is prohibited. The amendments remove this conflict, allowing the storage of not only epinephrine, but other life-saving medications such as insulin, inhalers, and over-the-counter medication, in day care centers. For these reasons, the regulatory action is expected to be noncontroversial and appropriate for the fast-track rulemaking process.

Substance: The amendments allow the storage of (i) epinephrine on the premises of a food establishment and (ii) medication for children attending day care in a facility that also has a food establishment license.

Issues: The primary advantage of the amendments to the public is the accessibility of epinephrine to properly trained food establishment employees to assist facility patrons who are experiencing anaphylaxis due to an allergic reaction. In the event of an allergic reaction, food establishment staff can serve as the first response to administer aid until medical professionals arrive to further assist. In addition, the amendments allow the storage of epinephrine in a food refrigerator of a day care center. This is particularly advantageous when space is limited in a facility. There are no known disadvantages to the public.

The amendments provide clarity to agency staff during inspections of day cares and industry staff regarding when medication is allowed on site. Clarity in the administration of the regulations is an advantage to the agency. By having epinephrine on site, restaurants can enhance customer and employee safety, reduce the risk of severe reactions, and demonstrate a commitment to catering to individuals with allergies. Any change to regulatory language that is proactive in anaphylaxis prevention is advantageous to all citizens in the Commonwealth. There are no known disadvantages to the agency 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 12VAC5-421 Food Regulations to specify that food establishments may store epinephrine and medicines for the use of children in a day care center. The existing regulation contains an extensive definition of "food establishment" that is not being amended by this proposed action.²

Background. The current 12VAC5-421-3460 states³ "A. Except for medicines that are stored or displayed for retail sale, only those medicines that are necessary for the health of employees shall be allowed in a food establishment. B. Medicines that are in a food establishment for the employees' use shall be labeled as specified under 12VAC5-421-3320 and located to prevent the contamination of food, equipment, utensils, linens, and single-service and single-use articles." Amendments Pertaining to Epinephrine from Chapter 853 of the 2020 Acts of Assembly states "Pursuant to an order or a standing protocol issued by the prescriber within the course of his professional practice, and in accordance with policies and guidelines established by the Department of Health, such prescriber may authorize any employee of a restaurant⁴ licensed pursuant to Chapter 3 (§ 35.1-18 et seq.) of Title 35.1 to possess and administer epinephrine on the premises of the restaurant at which the employee is employed, provided that such person is trained in the administration of epinephrine." Consequently, the board proposes to amend 12VAC5-421-3460 to indicate that food establishments may store epinephrine. Amendments Pertaining to Medicines for the Use of Children in a Day Care Center 12VAC5-421-3470 states that "Medicines belonging to employees or to children in a day care center that require refrigeration and are stored in a food refrigerator shall be: 1. Stored in a package or container and kept inside a covered, leakproof container that is identified as a container for the storage of medicines; and 2. Located so they are inaccessible to children." This text indicates that medication belonging to children in a day care center can be stored in a food refrigerator on the premises of the day care food establishment.⁵ This could be interpreted to conflict⁶ with 12VAC5-421-3460, which states "Except for medicines that are stored or displayed for retail sale, only those medicines that are necessary for the health of employees shall be allowed in a food establishment. To eliminate the conflict, the board proposes to amend 12VAC5-421-3460 to state that food establishments may store medicines for the use of children in a day care center.

Estimated Benefits and Costs. According to the Mayo Clinic, epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.⁷ Anaphylaxis is a life-threatening type of allergic reaction.⁸ Thus, allowing food establishments to store epinephrine has the potential to save lives. Virginia Department of Health (VDH) staff are not aware of any incidences of food establishments associated with child day care centers having been found in violation for storing medication for children on the premises. Nevertheless, the proposal to amend 12VAC5-421-3460 to state that food establishments may store medicines for the use of children in a day care center may be beneficial in that food establishments associated with child day care centers could know with certainty that they may do so.

Businesses and Other Entities Affected. The proposed amendments would potentially affect the food establishments that choose to obtain and store epinephrine on the premises. VDH has issued permits to more than 30,000 food establishments.⁹ It is not known how many would choose to obtain and store epinephrine. There are approximately 1,500 food establishments that are associated with child day care centers.¹⁰ To the extent that some have refrained from storing medication for children on the premises due to uncertainty on the law, they may also be affected even if they do not have plans to store epinephrine. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.¹¹ An 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. The proposed amendments neither add cost nor reduce revenue. Thus, no adverse impact is indicated.

Small Businesses¹² Affected.¹³ The proposed amendments do not appear to adversely affect small businesses.

Localities¹⁴ Affected.¹⁵ The proposed amendments do not appear to disproportionally affect particular localities or increase costs for local governments.

Projected Impact on Employment. The proposed amendments do not appear to affect total employment.

Effects on the Use and Value of Private Property. The proposal to allow food establishments to store epinephrine would likely lead to some such entities doing so. It would not likely substantively affect the value of these businesses. The proposed amendments do not affect 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 Food establishment is defined in the regulation as an operation that (i) stores, prepares, packages, serves, 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. Further, the regulation states a 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. Lastly, the regulation states a 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.

³ The text in the regulation includes superscripts that are not pertinent to the analysis in this report and have thus been removed from the quoted language.

⁴ According to the Virginia Department of Health (VDH), restaurant is synonymous with food establishment in the regulation. The agency states that it uses the word food establishment to be consistent with U.S. Food and Drug Administration model Food Code terminology.

⁵ According to VDH, a day care center that provides food service beyond the provision of prepackaged items that do not require temperature control would be operating as a food establishment.

⁶ See the third paragraph of the Mandate and Impetus section of the Agency Background Document: https://townhall.virginia.gov/l/GetFile.cfm?File=58\5941\9619\AgencyStatement_VDH_9619_v1.pdf.

⁷ See https://www.mayoclinic.org/drugs-supplements/epinephrine-injection-route/proper-use/drg-20072429?p=1.

⁸ See https://medlineplus.gov/ency/article/000844.htm.

⁹ Data source: VDH.

¹⁰ Ibid.

¹¹ 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.

¹² 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."

¹³ 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.

¹⁴ "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.

¹⁵ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The State Board of Health concurs with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments (i) allow storage of epinephrine on the premises of a food establishment pursuant to subdivision A 17 of § 8.01-225 of the Code of Virginia and (ii) allow storage of medication for children attending day care in a facility that also has a food establishment license.

12VAC5-421-3460. Medicines - restriction and storage.

A. Except for No food establishment may display medicines that are stored or displayed other than medicines for retail sale, only those medicines that are necessary for the health of employees shall be allowed in a food establishment.^Pf

B. No food establishment may store medicines other than the following:

1. Medicines for the use of children in a day care center;^P

2. Medicines that are referenced in § 8.01-225 A 17 of the Code of Virginia;^P and

3. Medicines that are necessary for the health of employees.^P

C. Medicines that are stored or displayed in a food establishment for the employees' use shall be labeled as specified under 12VAC5-421-3320 and located to prevent the contamination of food, equipment, utensils, linens, and single-service and single-use articles.^P