Title of Regulation: 2VAC5-595. Regulations Governing the Manufacturing and Sale of Products that Contain Industrial Hemp Extracts Intended for Human Consumption (adding 2VAC5-595-10 through 2VAC5-595-60).

Statutory Authority: § 3.2-5145.5 of the Code of Virginia.

Effective Date: August 15, 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) 786-8899, FAX (804) 371-7792, TDD (800) 828-1120, or email ryan.davis@vdacs.virginia.gov.

Summary:

Pursuant to Chapters 659 and 660 of the 2020 Acts of Assembly, which created a new article in the Virginia Food and Drink Law establishing requirements for the production, distribution, and sale of industrial hemp extracts intended for human consumption, this new regulation establishes a regulatory framework and standards for industrial hemp extract manufacturers. The regulation (i) identifies specific potential contaminants of industrial hemp extract or a food containing an industrial hemp extract and establishes tolerances for these contaminants; (ii) establishes labeling requirements for an industrial hemp extract or a food containing an industrial hemp extract; and (iii) provides testing requirements for industrial hemp extracts and criteria for independent testing laboratories that conduct required batch testing of industrial hemp extracts.

Amendments to the proposed regulation are in response to comments received during the required public comment period and language included in the 14th enactment clause of Item 4-14 of the 2022 Appropriation Act in § 3.2-5145.5 C of the Code of Virginia. The proposed regulation underwent a 60-day public comment period from November 8, 2021, through January 7, 2022, during which the agency received approximately 10 comments, with the primary concerns being the definition of "cannabinoid" and the regulation of delta-8 tetrahydrocannabinol (THC) products. The 2022 Appropriation Act mandates that this regulation address additional labeling requirements, which have been incorporated into the final regulation. Therefore the amendments to the proposed regulation include (i) clarifying the definition of "cannabinoid"; (ii) replacing language specifying contaminant limits for microbiological, mycotoxins, and heavy metals and pesticide chemical residue tolerances with references to identical limits for these contaminants established in the Board of Pharmacy's regulation that pertains to cannabis products produced by permitted pharmaceutical processors; and (iii) adding requirements for the package label of an industrial hemp extract that contains THC or food containing an industrial hemp extract that contains THC to reflect the mandatory labeling requirements established by the language in Item 4-14 of the 2022 Appropriation Act.

Chapter 595

Regulations Governing the Manufacturing and Sale of Products that Contain Industrial Hemp Extracts Intended for Human Consumption

2VAC5-595-10. Definitions.

The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Approved source" means a manufacturer of an industrial hemp extract or food containing an industrial hemp extract that operates (i) under inspection by the responsible food regulatory agency in the location in which such manufacturing occurs and (ii) in compliance with the laws, regulations, or criteria that pertain to the manufacturer of an industrial hemp extract or food containing an industrial hemp extract in the location in which such manufacturing occurs.

"Batch" means a specific quantity of an industrial hemp extract that is uniform and is produced during a specified period of time under similar conditions and identified by a specific code that allows traceability.

"Cannabinoid" means a naturally-occurring, biologically active, chemical constituent of Cannabis sativa [ , including cannabidiol (CBD), cannabidiolic acid (CBDA), delta-9-tetrahydrocannabinol (THC), and delta-9-tetrahydrocannabinolic acid (THCA) ].

"Consumer" means a person who (i) purchases an industrial hemp extract or a food containing an industrial hemp extract for personal use, (ii) is not functioning in the capacity of an operator of a food establishment or food processing plant, and (iii) does not offer the industrial hemp extract or food containing an industrial hemp extract for resale.

"Consumption" means oral ingestion.

"Contaminant" means any substance not intended to be an ingredient in a food and that is potentially harmful to the consumer.

"Department" means the Virginia Department of Agriculture and Consumer Services.

"Extract" means a naturally occurring phytochemical produced by the industrial hemp plant that has been removed from the inert structural material of the plant.

"Food" means any article that is intended for human consumption and introduction into commerce, whether the article is simple, mixed, or compound, and all substances or ingredients used in the preparation thereof. "Food" does not mean a drug as defined in § 54.1-3401 of the Code of Virginia. "Food" includes a dietary supplement.

"Industrial hemp" means any part of the plant Cannabis sativa with a concentration of tetrahydrocannabinol that is no greater than that allowed by federal law.

"Industrial hemp extract" means an extract (i) of a Cannabis sativa plant that has a concentration of tetrahydrocannabinol that is no greater than that allowed for hemp by federal law and (ii) that is intended for human consumption.

"Manufacturer" means a person that (i) produces a packaged food or a food intended to be used as an ingredient in a food and (ii) offers the food for sale directly to consumers or for wholesale distribution. "Manufacturer" does not include a person that adds an industrial hemp extract to food for immediate consumption by consumers in a retail food establishment or at a farmers' market, if that person did not produce the industrial hemp extract.

"Phytochemical" means any naturally occurring chemical compound in a plant.

"Processor" means a person registered pursuant to subsection A of § 3.2-4115 of the Code of Virginia to process industrial hemp.

"Production field" means the land or area on which a grower is growing or intends to grow industrial hemp.

"Retail food establishment" means a food business regulated under and operating in compliance with the Retail Food Establishment Regulations (2VAC5-585) and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia.

"Retail sale" means the sale of a product directly to a consumer.

"Total delta-9 tetrahydrocannabinol concentration" means the post-decarboxylation delta-9 tetrahydrocannabinol concentration, which can be determined using the following equation [delta-9 tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]).

"Wholesale distribution" means the sale of a product to an intermediate entity that intends to further distribute that product for retail sale.

2VAC5-595-20. Regulated articles.

Industrial hemp extracts and foods containing an industrial hemp extract are subject to the provisions of this chapter.

2VAC5-595-30. Inspection required.

A. A person that manufactures an industrial hemp extract in Virginia and introduces that industrial hemp extract into commerce shall first be inspected by the department for compliance with the requirements in 2VAC5-595-50.

B. To apply for an inspection to manufacture an industrial hemp extract or to introduce an industrial hemp extract into commerce, a person must:

1. Submit an application on a form provided by the [ commissioner department ]; and

2. Provide documentation of an unexpired Industrial Hemp Processor Registration issued pursuant to subsection A of § 3.2-4115 of the Code of Virginia.

2VAC5-595-40. General requirements.

A. A manufacturer shall produce an industrial hemp extract in compliance with Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia and Regulations Pertaining to Food for Human Consumption (2VAC5-600), including 21 CFR Part 117.

B. Notwithstanding subsection A of this section, a manufacturer shall produce an industrial hemp extract or food containing an industrial hemp extract in compliance with 21 CFR Part 111 if the industrial hemp extract or food containing an industrial hemp extract is:

1. Produced in a tablet, capsule, powder, softgel, or gel cap form;

2. Labeled with a panel titled "Supplement Facts"; or

3. Labeled with a statement that describes the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or ingredient acts to maintain such structure or function.

C. The manufacture or sale of food that contains an industrial hemp extract is not eligible for the exemption from inspection provided in § 3.2-5130 of the Code of Virginia.

D. A person offering for sale a food containing an industrial hemp extract shall obtain the industrial hemp extract from an approved source.

2VAC5-595-50. Laboratory testing required for contaminants and phytochemicals of an industrial hemp extract or a food containing an industrial hemp extract.

A. If an industrial hemp extract is used as an ingredient in a food and that industrial hemp extract was produced by a manufacturer that is an approved source pursuant to § 3.2-5145.3 of the Code of Virginia, that food containing an industrial hemp extract is not subject to the testing requirements prescribed in this section. However, a food containing an industrial hemp extract that contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section is adulterated.

B. A manufacturer of an industrial hemp extract shall submit for laboratory analysis a sample from each batch of industrial hemp extract the manufacturer produces. Such laboratory analysis shall only be performed by a laboratory that meets the requirements prescribed in subsection E of this section.

C. A batch whose sample contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section is adulterated. A manufacturer of an industrial hemp extract may not offer for sale or sell any industrial hemp extract from a batch whose sample contains any contaminant in an amount that exceeds an acceptable criteria or tolerance established in this section.

D. A manufacturer of an industrial hemp extract may not offer for sale or sell any industrial hemp extract from a batch whose sample does not contain the cannabinoid or phytochemical concentration claimed on the label for the industrial hemp extract.

E. The laboratory analysis required in subsection B of this section shall be performed by a laboratory that:

1. Has no direct or indirect financial interest in a manufacturer of an industrial hemp extract or in any other entity that may benefit from the production, manufacture, sale, purchase, or use of an industrial hemp extract or product containing an industrial hemp extract. Additionally, no person with a direct or indirect financial interest in the laboratory shall have a direct or indirect financial interest in a manufacturer of an industrial hemp extract or in any other entity that may benefit from the production, manufacture, sale, purchase, or use of an industrial hemp extract or product containing an industrial hemp extract.

2. Employs at least one person to oversee and be responsible for the laboratory testing who has earned from a college or university accredited by a national or regional certifying authority at least (i) a master's degree in chemical or biological sciences and a minimum of two years of post-degree laboratory experience or (ii) a bachelor's degree in chemical or biological sciences and a minimum of four years of post-degree laboratory experience.

F. The microbiological content in a sample from a batch of industrial hemp extract shall [ not exceed the following acceptable criteria:

meet the standard for the microbiological test established in 18VAC110-60-300. ]

G. The mycotoxin content in a sample from a batch of industrial hemp extract shall [ not exceed the following acceptable criteria:

meet the standard for the mycotoxin test established in 18VAC110-60-300. ]

H. The heavy metal content in a sample from a batch of industrial hemp extract shall [ not exceed the following acceptable criteria:

meet the standard for the heavy metal test established in 18VAC110-60-300. ]

I. The residual solvent content in a sample from a batch of industrial hemp extract shall not exceed the following acceptable criteria:

J. Any pesticide applied to industrial hemp or during the processing of industrial hemp must be done so in accordance with the label of that pesticide and in compliance with the Virginia Pesticide Control Act (§ 3.2-3900 et seq. of the Code of Virginia) and regulations adopted thereunder. For at least three years, the manufacturer of an industrial hemp extract shall maintain pesticide application records for the industrial hemp from which it produces the industrial hemp extract.

K. The pesticide chemical residue content in a sample from a batch of industrial hemp extract shall [ not exceed the most stringent tolerance for a pesticide chemical residue in any food item as set forth by the U.S. Environmental Protection Agency's regulations for Tolerances and Exemptions for Pesticide Chemical Residues in Food in 40 CFR Part 180, Subpart C meet the standard for the pesticide chemical residue test established in 18VAC110-60-300 ]. Pesticide chemical residue testing shall include testing for carbamates, organochlorines, and [ organophophates organophosphates ].

L. The total delta-9 tetrahydrocannabinol concentration of a sample from a batch of industrial hemp extract shall not exceed 0.3%.

M. If a manufacturer labels an industrial hemp extract as having any amount of a cannabinoid, a sample from a batch of the industrial hemp extract shall be tested and shall have the claimed amount of the cannabinoid. If a manufacturer labels an industrial hemp extract as having any amount of phytochemical, including a terpene or flavonoid, a sample from a batch of the industrial hemp extract shall be tested and shall have the claimed amount of the phytochemical.

N. If batch testing of industrial hemp extracts from industrial hemp grown in a specific production field consistently shows that levels of contaminants do not exceed the limits established in this chapter, the frequency of batch testing by the manufacturer may be adjusted after consultation with the department. The manufacturer shall retain documentation of the reasoning for adjustment of batch testing frequency and the recommendation of the department and make such available to the department on request.

O. The manufacturer shall maintain industrial hemp extract testing records for at least three years.

2VAC5-595-60. Labeling of industrial hemp extracts and foods containing an industrial hemp extract.

A. For the purpose of this chapter, label or labeling includes the label on the packaging of an industrial hemp extract or food containing an industrial hemp extract as well as any brochure, advertisement, information on social media or on any website, or any other form of product marketing.

B. An industrial hemp extract or food containing an industrial hemp extract shall be labeled in accordance with 21 CFR Part 101 and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia.

C. Notwithstanding subsection B of this section, a manufacturer shall label an industrial hemp extract or food containing an industrial hemp extract in compliance with the labeling provisions for dietary supplements in 21 CFR Part 101 and Chapter 51 (§ 3.2-5100 et seq.) of Title 3.2 of the Code of Virginia if the industrial hemp extract or food containing an industrial hemp extract is:

1. Produced in a tablet, capsule, powder, softgel, or gel cap form;

2. Labeled with a panel titled "Supplement Facts"; or

3. Labeled with a statement that describes the role of a nutrient or ingredient intended to affect the structure or function in humans or that characterizes the documented mechanism by which a nutrient or ingredient acts to maintain such structure or function.

D. If a manufacturer labels an industrial hemp extract or food containing an industrial hemp extract as containing a specific cannabinoid or concentration thereof, the number of milligrams of [ each such ] cannabinoid must be declared on the product label. The manufacturer must make and maintain records verifying the declared amount of cannabinoid. Such records may include a recipes, formulation, or batch record.

E. The label of an industrial hemp extract or food containing an industrial hemp extract shall not contain a claim indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, which shall render the product a drug, as that term is defined in 21 USC § 321(g)(1). An industrial hemp extract or food containing an industrial hemp extract with a label that contains a claim indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease is not a food and shall be considered misbranded.

F. A manufacturer shall identify each batch of an industrial hemp extract or a food containing an industrial hemp extract with a unique code for traceability. Julian date coding or any other system developed and documented by the manufacturer for assigning a unique code to a batch may be used. The batch identification shall appear and be legible on the industrial hemp extract label.

G. The label of an industrial hemp extract [ or a food containing an industrial hemp extract shall include a statement that the product contains a total delta-9-tetrahydrocannabinol concentration that does not exceed 0.3% or shall state the specific total delta-9-tetrahydrocannabinol concentration of the product that contains tetrahydrocannabinol or a food containing an industrial hemp extract that contains tetrahydrocannabinol must be equipped with a label that states:

1. That the industrial hemp extract or food containing an industrial hemp extract contains tetrahydrocannabinol and may not be sold to a person younger than 21 years of age;

2. All ingredients contained in the industrial hemp extract or food containing an industrial hemp extract;

3. The amount of such industrial hemp extract or food containing an industrial hemp extract that constitutes a single serving; and

4. The total percentage and milligrams of tetrahydrocannabinol included in the industrial hemp extract or food containing an industrial hemp extract and the number of milligrams of tetrahydrocannabinol that are contained in each serving ].

FORMS (2VAC5-595)

[ Application for Manufacturer of an Industrial Hemp-Derived Extract Intended for Human Consumption, ODF-FSP-10595 (eff. 12/2020)

Application for Manufacturer of an Industrial Hemp-Derived Extract Intended for Human Consumption, VDACS-FSP-APPIH (rev. 6/2022) ]