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By James V. Aidala and Susan M. Kirsch

On October 31, 2019, as required by the 2018 Farm Bill, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service published its interim rule, “Establishment of a Domestic Hemp Production Program” (Interim Rule).  The Interim Rule proposal specifies rules and regulations governing hemp production in the U.S., including:

  • Requirements for state/tribal plans for states pursuing regulatory authority over hemp production;
  • Recordkeeping requirements;
  • Licensing requirements;
  • Delta-9 tetrahydrocannabinol (THC) testing;
  • Procedures for disposing of non-compliant plants; and
  • Compliance provisions and procedures for handling violations.

The Interim Rule does not alter the federal definition distinguishing hemp from marijuana, a distinction hinging on the levels of THC in the plant. Plants containing 0.3 percent or less THC on a dry weight basis are considered hemp, while plants exceeding this level of THC are marijuana. The Interim Rule introduces the term “acceptable hemp THC level” to account for a degree of uncertainty in testing results and explains how to interpret lab results with a measurement of uncertainty.  This is a critical clarification given that THC levels dictate whether a grower is engaged in the legal production of hemp or is growing marijuana -- prohibited federally and in the majority of states.

The USDA is not proposing a single uniform testing method and will accept numerous testing methods and protocols employed by states. The Interim Rule does not include a federal seed certification program. The Interim Rule makes clear that interstate transport of hemp is permissible regardless of whether the states the shipment passes through allow hemp production.

The publication of the Interim Rule initiates USDA’s implementation of the hemp program, which includes reviewing state/tribal plans and issuing licenses. USDA will accept public comments on the Interim Rule for 60 days through December 30, 2019.  Within two years of publication, USDA will publish a final rule.  Also relevant for hemp producers are forthcoming proposals from the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency (EPA) addressing the sale of cannabidiol (CBD) and pesticide approvals for application to hemp plants, respectively.

Commentary

For some, federal policies facilitating hemp production not only is a long-awaited policy goal, but a kind of “gateway drug” (pun intended) for renewing the debate about approval for pesticide products to be used on the legal production of marijuana crops.

To date, the federal government position is that since marijuana production is not allowed under federal law, attempts by states to permit pesticides for state use are forbidden.  Some states have argued that since their state law allows the production of marijuana crops, pesticide products should be subject to registration under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency use or FIFRA Section 24(c) special local needs.

Separate from any debate about marijuana production, residues of pesticides on hemp products intended for human consumption, such as CBD products, will force EPA to consider how such products should be reviewed.  Those policies, in time, will be relevant to any eventual evaluation of similar exposure and risk assessment questions regarding approval of pesticide products to be used in marijuana production.

Tags: USDA, hemp, THC, CBD

 

By Lisa M. Campbell and Timothy D. Backstrom

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the receipt of 10 applications to amend currently registered pesticide products to add hemp as a new use site.  The 10 application amendments are the result of the 2018 Farm Bill, signed in to law on December 20, 2018, that removed hemp from the Controlled Substances Act and legalized commercial use and production of hemp that contains less than 0.3% tetrahydrocannabinol (THC).

EPA states in the notice that Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(c)(4) does not require EPA to provide notice and opportunity to comment concerning these 10 applications because hemp falls within the terrestrial outdoor and residential outdoor use pattern previously approved for the pesticidal active ingredients in question, and approval of the applications would therefore not involve "a changed use pattern."  Instead, EPA states that it has decided to provide an opportunity to comment in this instance "because of the potential significant  interest from the public" and to be "completely transparent about these applications." EPA also states that it does not intend to provide notice or opportunity to comment for similar applications to add hemp that are likely to be submitted in the future.

EPA also states that the products with requested label amendments contain active ingredients for which EPA "has previously determined the residues will be safe under any reasonably foreseeable circumstances." Each active ingredient has an established tolerance exemption for residues on all raw agricultural or food commodities.

The 10 products for which EPA has received an application to add hemp are:

  1. Debug Turbo, EPA Registration No. 70310-5, active ingredients: azadirachtin and neem oil;
  2. Debug Optimo, EPA Registration No. 70310-7, active ingredients: azadirachtin and neem oil;
  3. Debug Trés, EPA Registration No. 70310-8, active ingredients: azadirachtin and neem oil;
  4. Debug-ON, EPA Registration No. 70310-11, active ingredient: neem oil;
  5. REGALIA Bioprotectant Concentrate, EPA Registration No. 84059-3, active ingredient: extract of Reynoutria sachalinensis;
  6. MBI-110 EP, EPA Registration No. 84059-28, active ingredient: Bacillus amyloliquefaciens strain F727;
  7. GH CMT, EPA Registration No. 91865-1, active ingredients: soybean oil, garlic, oil, and capsicum oleoresin extract;
  8. GH MPMT, EPA Registration No. 91865-2, active ingredient: potassium salts of fatty acids;
  9. GH DNMT, EPA Registration No. 91865-3, active ingredient: Bacillus amyloliquefaciens strain D747; and
  10. GH NAMT, EPA Registration No. 91865-4, active ingredient: azadirachtin.

Once public comments are received, EPA anticipates making its decision on adding hemp as a new use site on the specific products before the end of 2019, so that these products may be available for the 2020 growing season.

Commentary

Although the Federal government has legalized commercial production and use of hemp (as opposed to marijuana that contains higher levels of THC), not every State has changed its laws to conform to the new classification.  EPA took the unusual step of announcing receipt of the new amendment applications at Hemp Production Field Day at the University of Kentucky.  Senator Rand Paul of Kentucky has long been a proponent of commercial hemp production, and about 1,000 growers in Kentucky now have licenses to grow hemp for commercial use.

As hemp production increases, there will also be increased demand for pesticides to combat weeds, insects, and plant diseases that pose a potential threat to this crop.  Although hemp fiber and oil have many potential industrial uses, hemp also has potential medicinal uses because extracts containing cannabidiol (CBD) are now being widely marketed for their purported health benefits.  This use of hemp means that EPA will have to consider whether new tolerances may be required for some active ingredients before they can applied to hemp.  As EPA has noted, the active ingredients in the 10 products for which EPA announced that applications are pending to add labeling for hemp already have tolerance exemptions, and therefore do not present this issue.

Comments are due on or before September 23, 2019.  The public can submit comments at www.regulations.gov in Docket Number EPA-HQ-OPP-2019-0369.