For the proposed 2VAC5-595-60.D, the information on how a manufacturer determines concentration of cannabinoids should be made publicly available, to the consumers. In addition, there should be a laboratory verification requirement. Alcohol manufacturers are required to list and test ABV, cannabis manufacturers should be required to do the same for cannabinoids for consumer safety and transparency. 

The proposed regulation has failed to address Delta 8. As written Delta 9 and Delta 10 are  addressed in such a manor that one can conclude theses two products as unique substances. How ever the absence of Delta 8 gives a wondering if the regulation is an effort to redefine Delta 8, a legal substance at the Federal level. Delta 8's properties are unique in such away that the Federal level has classified this substance as legal. As a result many small businesses use Delta 8 as a core source of there business revenues. This regulation as written makes inferences that could make Delta 8 illegal and eventually destroy small businesses. Go back to the table and leave Delta 8 alone.

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.

In this proposed regulation regarding industrial hemp extracts ...
The definition of “Cannabinoid” references CBD, CBDA, Delta 9 THC and Delta 9 THCa however, it does not reference Delta 8 THC whatsoever. Delta-8 THC has a very similar chemical formula as Delta 9 THC, with a slight difference in molecular structure. Therefore, they cannot be considered as “the same”. To suggest so is disingenuous. Delta 8 THC must be specially referenced and not tethered to Delta 9 THC or any other cannabinoid. Each MUST be respectfully defined and addressed.

Delta-8 THC is considered legal at the federal level because it is derived from the hemp plant, instead of marijuana. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated amounts of Delta 8 THC are typically manufactured from hemp-derived cannabidiol (CBD).

Further, NIH PMID: 34797727. DOI: 10.1089/can.2021.0124. Concludes that harm reduction is a central component of public health. Although the legal environment is becoming more restrictive for Delta 8 THC in comparison to Delta 9 THC, results suggest that Delta 8 THC may be equally effective for desired purposes of cannabis use and lower in undesirable or adverse effects.
With no mention of Delta 8 THC in the cannabinoid definition it brings to question if you intend to include it within the Delta 9 THC cannabinoids. Which is misleading. Wouldn't it be prudent to address them individually?

To outlaw Delta 8 THC, which is not identified or referenced anywhere in these proposed cannabis regulations, is to cut the lifeline of so many small businesses, like myself and others, in the newly emerging and lucrative industry in The Commonwealth of Virginia.

This regulation being proposed leaves a lot of room to ban currently legal molecules like Delta 8.  Which is still a hemp product as defined by federal law.  As a small farm and retail brand, the banning of D8 would hurt our business out of business as a good portion our sales are Delta 8 related products.  

If you want the billion dollar marijuana conglomerates to continue to dominate over small businesses, do not change a sentence from your proposed changes.  

 As regulators contemplate the legal status of the cannabinoid Delta 8 THC, officials with the Drug Enforcement Administration (DEA) are signaling that, at the federal level at least, it’s not a controlled substance at this time.

Officials with the DEA have indicated to state regulators that only products containing more than 0.3 percent Delta-9 THC—the most commonly known intoxicating cannabinoid—is controlled, but the 2018 Farm Bill that legalized hemp does not explicitly ban THC isomers like Delta 8 THC. 

Virginia is cutting off revenue from its own small business who live and thrive off the production and sale of Delta 8 THC. 

Changing definitions that are not consistent with the general understanding, universally accepted scientific meanings, or federal legal definitions is not right.  It is a slippery slope that can drastically change the industry for the worse.  For example, a cannabinoid is a chemical compound, regardless of structure or origin, that joins the cannabinoid receptors of the body and brain.  Albeit, most notably found in cannabis but also present in echinacea, electric daisy and black pepper.  Alcohol is a great example of many sources (grain, sugarcane, beets, coal ash) and forms (wine, beer, sake, etc) - all are consider alcoholic beverages. 

I do not understand the change in definitions unless the next steps were to regulate the new, popular and industry supporting novel cannabinoids like Delta 8 THC, CBN, etc.  The biggest flaw I see in regulating a chemical reaction is, that is the basis of the industry.  We take CBDa through an exothermic reaction to form CBD.  We can use light to change Delta 9 THC to CBN.  If Delta 8 reaction is going to be limited, will these other reactions suffer as a result?

Stay with the federal definitions!!!