Title of Regulation: 2VAC5-560. Rules and Regulations Pertaining to Labeling and Sale of Infant Formula (amending 2VAC5-560-50, 2VAC5-560-70).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: February 16, 2022.

Effective Date: March 3, 2022.

Agency Contact: Ryan Davis, Program Manager, Office of Dairy and Foods, Department of Agriculture and Consumer Services, P.O. Box 1163, Richmond, VA 23218, telephone (804) 786-8910, FAX (804) 371-7792, TDD (800) 828-1120, or email ryan.davis@vdacs.virginia.gov.

Basis: Section 3.2-109 of the Code of Virginia establishes the Board of Agriculture and Consumer Services as a policy board with the authority to adopt regulations in accordance with the provisions of Title 3.2 of the Code of Virginia. Section 3.2-5121 of the Code of Virginia grants the board authority to adopt regulations for the efficient enforcement of Article 3 (§ 3.2-5120 et seq.) of Chapter 51 of Title 3.2 of the Code of Virginia, which pertains to the adulteration, misbranding, and false advertising of food.

Purpose: The purpose of the proposed amendments is to ensure that the regulation and its references are accurate. The proposed amendments protect the health, safety, and welfare of Virginia's citizens in that they ensure that the regulation and the Code of Virginia references contained therein are current and enforceable. A current and enforceable infant formula regulation will ensure that infants receive and consume infant formula that is nutritious and capable of supporting the infant's growth, health, and wellbeing. The goal of the proposed amendments is to ensure a regulation with references to the Code of Virginia that are accurate, updated, and enforceable.

Rationale for Using Fast-Track Rulemaking Process: A periodic regulatory review of this regulation identified references to the Code of Virginia that are outdated and inaccurate. These sections needed to be amended to reflect an accurate reference. This rulemaking is expected to be noncontroversial and therefore appropriate for the fast-track rulemaking process because the proposed amendments simply ensure the regulation is accurate.

Substance: The misbranding provision in this regulation references a Code of Virginia section that was eliminated when Title 3.1 was recodified. The proposed amendment updates the reference to § 3.2-5123 A 1 of the Code of Virginia.

The section of this regulation pertaining to the sale of a product unfit for food also references an obsolete section of Title 3.1 of the Code of Virginia and will be updated to subdivision 3 of § 3.2-5122 of the Code Virginia.

Issues: The proposed amendments will ensure an accurate, updated, and enforceable regulation. The amended regulation will further ensure that infant formula is not sold beyond the scientifically determined expiration date and will further ensure that infants will consume nutritionally sound formula in order to ensure the infant's health, growth, and development.

The primary advantage to the agency and Commonwealth is that the agency can ensure an enhanced degree of public health protection by ensuring that infant formula consumed in the Commonwealth is nutritionally sound.

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

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. As the result of a 2021 periodic review,¹ the Board of Agriculture and Consumer Services (Board) is proposing to update two references to the Code of Virginia.

Background. This regulation requires that any container of infant formula manufactured or sold in the Commonwealth of Virginia conspicuously show the calendar month and year after which the product is not to be sold or used for human consumption. For many children, infant formula is the sole source of nutrition during the initial stages of life. Manufacturers must ensure scientifically that infant formula consumed contains the appropriate spectrum and quality of nutrients required for growth and development as long as the formula is consumed by the expiration date and retailers must ensure that expired infant formula is not sold to consumers.

The regulation provides that any infant formula manufacturer knowingly filing incorrect or unverifiable data with the Commissioner or placing an expiration date upon a shipping carton, container, or any consumer package that is inconsistent with the data filed with the Commissioner shall be considered to have misbranded the formula.

The regulation also states that any manufacturer, distributor, dealer, or other person who offers for sale or sells infant formula without an expiration date, or who offers for sale or sells infant formula after the expiration date shown, shall be deemed to be offering for sale a product that is unfit for food.

The misbranding provision in this regulation references a section of the Code of Virginia (Code) that addresses misbranding. The section of the Code that is referenced, § 3.1-396(a), no longer exists, as Title 3.1 of the Code was recodified in 2008.² The correct reference to the statue is now § 3.2-5123(a)(1). The proposed amendment updates the reference so that it refers to the correct section of the Code of Virginia.

Similarly, the section of this regulation pertaining to the sale of a product unfit for food references a section of the Code that addresses adulterated food products. This section of the Code that is referenced, § 3.1-395(a)(3), also no longer exists due the recodification of Title 3.1 in 2008. The regulation should reference § 3.2-5122(3). The proposed change updates the reference so that it refers to the correct section of the Code.

Estimated Benefits and Costs. The proposed changes simply update references to the Code of Virginia regarding misbranding and unfit food without any change in regulatory requirements. Therefore, no significant economic effect is expected other than improving the accuracy of the regulatory text.

Businesses and Other Entities Affected. This regulation applies to one manufacturer of infant formula in the Commonwealth and approximately 9,000 retail establishments that may be offering infant formula for sale. No adverse economic impact³ on any entity is indicated.

Small Businesses⁴ Affected. The proposed amendments do not adversely affect small businesses.

Localities⁵ Affected.⁶ The proposed amendments do not introduce costs for local governments and do not affect any particular locality.

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

Effects on the Use and Value of Private Property. No impact on the use and value of private property or on the real estate development costs is expected.

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¹https://townhall.virginia.gov/L/ViewPReview.cfm?PRid=1984

²https://lis.virginia.gov/cgi-bin/legp604.exe?ses=081&typ=bil&val=ch860

³Adverse 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.

⁴Pursuant 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."

⁵"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.

⁶§ 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 update citations to the Code of Virginia that changed due to the recodification of Title 3.1 to Title 3.2 pursuant to Chapter 860 of the 2008 Acts of Assembly.

2VAC5-560-50. Misbranding.

Knowingly filing incorrect or unverifiable data with the commissioner, or placing an expiration date upon a shipping carton, container, or any consumer package which that is inconsistent with the data filed with the commissioner, shall be considered to be misbranding under § 3.1-396(a) § 3.2-5123 A 1 of the Code of Virginia. However, it shall not be considered misbranded if the expiration date shown is an earlier date than the filed data could warrant.

2VAC5-560-70. Sale of a product unfit for food.

Any manufacturer, distributor, dealer, or other person who offers for sale or sells infant formula without an expiration date, or who offers for sale or sells infant formula after the expiration date shown, shall be deemed to be offering for sale a product unfit for food within the meaning of § 3.1-395(a)(3) as described in subdivision 3 of § 3.2-5122 of the Code of Virginia.

FORMS (2VAC5-560)

Inspection Report, Form VDACS-06017.