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Marijuana Extract Rule Stifles Hemp Industry

USDA hemp rule needs big changes, more groups say

Several industry organizations suggested the interim final rule (IFR) governing hemp production in the U.S. has ample room for improvement.

A number of big-name hemp CBD groups have raised concerns over an interim hemp production rule adopted by the U.S. Department of Agriculture (USDA).

All of them are aligned with the overarching comment from the American Herbal Products Association (AHPA), which said the IFR has “significant room for improvement” for hemp farmers to realize the benefits of what could be America’s latest commodity crop.

The IFR outlines provisions for USDA to approve plans submitted by states and Native American tribes for the domestic production of hemp—the plant that is the source material for CBD.

While USDA says the IFR is in effect for two years, until all comments are reviewed and a final rule written, leading-edge states like Colorado, Oregon and Kentucky are operating under the 2014 farm bill rules because the new IFR is so onerous. 

“AHPA believes that there exists significant room for improvement in the IFR and the subsequent Final Rule,” AHPA Director of Program Development Jane Wilson stated in written comments filed with USDA.

AHPA’s comments included the following specifics, which the group filed in much greater detail and can be viewed here.

  • The requirement to test hemp for THC content within 15 days prior to harvest provides insufficient time to reliably complete THC compliance testing and harvest activities.
  • Analytical laboratories should not be required to be DEA-registered to perform THC compliance testing.
  • Law enforcement should not perform sampling of hemp plant material for pre-harvest testing.
  • The provision regarding interstate transportation of hemp should specify the controlling THC test result to avoid legal disputes.
  • Acceptable disposal of non-compliant plant material should include other methods besides crop destruction.
  • Setting the negligence threshold at 0.5% THC does not provide sufficient protection for hemp producers.

Other orgs follow suit

Vote Hemp, the nation’s longest-serving advocacy organization for federal policy regarding hemp farming and hemp product manufacturing, said USDA's rules “raise serious concerns for our stakeholders, hemp producers, processors and manufacturers.”

The group led with comments about the negligence threshold, and how allowing for natural variation is important, especially in this new age of testing a plant for a certain cannabinoidnamely the euphoric THC cannabinoid.

Vote Hemp is concerned that measuring of sampling uncertainty was not included in the IFR,” wrote the group to USDA“Hemp-testing laboratories will have insufficient insight into the crop sampling process to properly calculate total uncertainty. Sampling and genetics measurements of uncertainty must reasonably be factored into overall measure of uncertainty for a final determination on whether or not a crop falls within the acceptable hemp THC level range.”

A farmer that unwittingly produces a hemp crop above the 0.3% THC limit could lose the entire crop—a result more devastating than a hail storm since that would at least possibly be eligible for crop insurance. A “hot” crop (north of 0.3% THC) could also lead to a felony conviction if it exceeds USDA's "negligence" threshold of 0.5% THC. 

Vote Hemp noted the 2018 farm bill specifically did not create strict liability for producers of plants exceeding 0.3 percent THC, so it faults USDA for creating one.

“USDA erred in creating a numerical threshold to determine a negligent violation, as it does not provide nearly enough of a margin for unintentional and non-negligent error,” wrote Vote Hemp. “Although negligent violations are not criminally enforceable at any level of government under the 2018 farm bill provisions, the IFR tacitly permits civil action by law enforcement agencies.”

The group also opposes the sampling guidelines, specifically that samples can be taken from only the top one-third of the plant.

“This upper portion of the plant is not the only part of the plant that is used in the manufacturing of hemp products,” Vote Hemp stated in its written comments. “Moreover, the highest concentration of THC is found in this top portion of the plant, which will result in an inaccurate measurement of THC in the plant itself. In order to get a more accurate reading of hemp THC concentration, all flowering portions of the selected plant must be sampled and homogenized.”

Into the weeds

NSF International, an independent, non-profit standards-setting and testing organization, concurred. The total THC present in tests, NSF said, should be the sum of THC and delta-9 THCA.

The organization's comments to USDA went deep in the weeds—one comment questioned the need for testing labs to use screens no larger than 1.5 x 1.5 mm in order to remove stems and seeds.

“As stems, seeds and twigs are part of hemp biomass,” wrote Stan Hazan, senior director of science and regulatory affairs for NSF, “we are uncertain as to the purpose of removing this biomass.”

Vote Hemp echoed AHPA’s comments about the onerous 15-day testing window, the disposal of non-compliant crops, and the DEA registered labs proviso.

Specific to the sampling and testing guidelines issued by USDA, AHPA had these comments:

  • Hemp sample preparation procedures are overly burdensome for analytical laboratories.
  • Hemp sampling protocols should be designed to achieve a more representative compliance testing sample.
  • USDA's Agriculture Marketing Service (AMS) should clarify how it intends to evaluate if alternate testing protocols meet the requirements of the testing guidelines.
  • AMS should provide a public list of approved THC analytical methods.
  • Determination of moisture content during analytical process and calculation of measurement of uncertainty require clarification.

The Minnesota Department of Agriculture (MDA) also added its experience, specifically around the negligence threshold.

In its comments filed with USDA, MDA noted 13 percent of the hemp samples taken in 2019 tested over the THC limit. The average THC level in those failures was 1.07% delta-9 THC post-decarboxylation.

“Most of these cases show that hemp farmers are doing the best they can to select good seed with predictable genetics, and at times have been misled by seed companies,” wrote Thom Petersen, commissioner of the MDA. “Until hemp genetics and regulation of the hemp seed industry improve, this entirely puts the burden of testing high on the farmers.”

Minnesota officials also criticized USDA's interim regulation prohibiting a farmer from growing hemp for five years if he negligently violates a state or tribal plan three times in a five-year period.  

“The 0.5% THC level is far too low to be considered ‘negligent,’” MDA wrote. “This low threshold also discourages experimentation and research. During the pilot program, hemp farmers grew multiple varieties to see which ones performed best. If farmers are worried about receiving three negligent violations in five years, they will not risk growing new varieties, stifling innovation in this new industry.”

The newly created CBD Association (CBDA), headed by supplements industry veteran John Venardos, who ran global regulatory affairs at Herbalife for 17 years and more recently oversaw regulatory compliance at Bodybuilding.com, had 17 specific comments on the IFR.

Most were in accord with other comments, but the CBD Association also advocated for banking reform. 

“Numerous financial institutions previously viewed transactions with the industry as representing a legal or regulatory risk,” wrote Venardos. “CBDA hopes the IFR will clarify the situation with regards to banks, credit card companies and other financial institutions that can service the hemp and hemp-derived CBD industry, which operate in this sector as safe, legal enterprises.”

CBDA also advocated clarifying interstate commerce of hemp and hemp-derived products so that federal regulations would preempt state transportation laws that consider hemp to still be illegal.

 

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