COMMENTS ON PROPOSED REGULATIONS

RELATED TO INDUSTRIAL HEMP EXTRACTS

Provided by

The Cannabis Business Association of Virginia

CannaBizVA^®

January 7, 2022

EXECUTIVE SUMMARY

The Cannabis Business Association of Virginia provides the following comments on the Proposed Regulation related to Industrial Hemp Extracts (“Proposed Regulations”).  The Association provides its comments to raise awareness of certain procedural and substantive provisions of the Proposed Regulations that it believes would benefit from additional review, discussion, and in some cases, redrafting.

The Association believes that certain Definitions set forth in Proposed Regulations 2VAC5-595-10 are vague, resulting in uncertainty as to their scope and reach.  For example, the proposed definitions for the terms “cannabinoid,” “extract,” “phytochemical,” all refer to “naturally occurring” chemical or phytochemical compounds.  However, because the Cannabis Sativa plant includes hundreds of such “naturally occurring” compounds, the Proposed Regulations should be more specific as to which of the compounds are impacted by the Proposed Regulations, and in particular with respect to certain cannabinoids that naturally occur in very low amounts.  

Notably, the terms:

1. “tetrahydrocannabinol” is not defined in the Proposed Regulations.
2. “Batch” needs more specificity regarding the “specified period of time” and would be better if written as:

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

3. “Cannabinoid” is incomplete and scientifically inaccurate and would be better if written as:

"Cannabinoid" means a naturally-occurring, biologically active, chemical constituents of Cannabis sativa, including but not limited to cannabidiol (CBD), cannabidiolic acid (CBDA), delta-9-tetrahydrocannabinol (THC), and delta-9-tetrahydrocannabinolic acid (THCA).

4. “0.3%” in the context of delta9-THC leaves the code vulnerable to change in federal law on that issue and, as such, is best replaced with:

the amount prohibited by federal lawThe Association understands and agrees with the need for mandatory Laboratory testing for contaminants and phytochemicals of an industrial hemp extract or a food containing an industrial hemp extract.  To that end, the Association notes that 2VAC5-595-50 § L. is I) redundant because the definition of “industrial hemp extract” already requires the delta-9 THC content not exceed that allowed by federal law per (see 2VAC5-595-10 above), II) in jeopardy upon any change in federal law. Consequently, it should be removed entirely. In the alternative, 2VAC5-595-50 § L. should be amended to I) apply only to a finished product or finished products per existing Federal law specifically allowing possession, transfer and transportation of Work-In-Progress-Hemp-Extract (WIPHE) and II) replace 0.3% with “the amount prohibited by federal law”

The Association is also concerned with respect to certain provisions of the Proposed Regulations regarding labeling and testing requirements.  For example, Proposed Regulation 2VAC5-595-60, subsection D, requires that if a manufacturer labels an extract or food as containing “a specific cannabinoid” the manufacturer must include on the label the milligram concentration of “each cannabinoid.”  It is therefore unclear whether this provision requires testing and labeling of all cannabinoids in the extract or food, or only those that the manufacturer chooses to list on the label. Proposed Regulation 2VAC5-595-50, subsection M, similarly requires the testing and documented support for any such cannabinoids listed on a manufacturer’s label.  Here again, it is unclear whether such testing and labeling is required for all cannabinoids contained within a product, or whether the manufacturer may choose to test for and maintain documented support for only those cannabinoids (or other phytochemicals such as terpenes, and flavonoids) listed on the label.

Similarly, proposed section 2VAC5-595-40, subsection C, denies exemptions from inspection of Virginia Code Section 3.2-5130, which negatively impacts a number of smaller “Private home” processors.

The Association has additional comments on a section-by-section basis and is prepared to provide same upon request.  These comments are not meant to be exhaustive, but rather are provided to demonstrate other sections of the Proposed Regulations that may benefit from addition discussion and comment.