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 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 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 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:

Residual solvent

Acceptable criteria

1,2-Dichloroethene

5 ppm

1,1-Dichloroethene

8 ppm

Acetone

5,000 ppm

Acetonitrile

410 ppm

Benzene

2 ppm

Butane

2,000 ppm

Chloroform

60 ppm

Ethanol

5,000 ppm

Ethyl Acetate

5,000 ppm

Ethyl Ether

5,000 ppm

Ethylene Oxide

5 ppm

Heptane

5,000 ppm

Hexane

290 ppm

Isopropyl Alcohol

500 ppm

Methanol

3,000 ppm

Methylene Chloride

600 ppm

Pentane

5,000 ppm

Propane

2,100 ppm

Toluene

890 ppm

Trichloroethylene (1,1,2-Trichloroethene)

80 ppm

Xylenes, Total (ortho-, meta-, para-)

2,170 ppm

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 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 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.