Minnesota Hemp Association's Comments on the U.S. Department of Agriculture Interim Final Rule on on Establishment of a Domestic Hemp Production Program
Bill Richmond, U.S. Domestic Hemp Production Program
United States Department of Agriculture
1400 Independence Ave SW
Washington, D.C. 20228
Dear Mr. Richmond:
The Minnesota Hemp Association (MHA) is Minnesota’s largest member-based association representing hemp farmers, processors, manufacturers, retailers, distributors, and service providers. MHA’s priorities are to (1) mitigate risks, (2) expand markets, and (3) build capacity to support the growth and vitality of Minnesota’s hemp industry from seed to sale.
Under the auspices of the Minnesota Department of Agriculture (MDA), Minnesota’s Industrial Hemp Pilot Program has developed over the last four years to include over 340 licensed hemp growers cultivating more than 8,000 acres of hemp in 80 out of 87 Minnesota counties. MDA received over 700 additional applications to the Program in 2019, up from 65 in 2018. The growth of Minnesota’s hemp sector has been widely embraced, especially in regions of the state looking to diversify their economies and create jobs beyond extractive and other stagnating industries.
Current Pilot Program licensees and those whose applications to the Program will be accepted in the near term bear the aggregate of the considerable risks that are endemic to the uncertainties of being early entrants to any emergent industry and to the cultivation of any agricultural commodity compounded with the risks that are associated with producing and selling a material only recently removed from Schedule I of the Controlled Substances Act. The long-term viability and success of the hemp industry both in Minnesota and nationally depends in great part on the development of oversight systems that protect public health and safety while reducing uncertainties that hamper innovation and growth.
MHA elicited feedback and input from our members about the anticipated impacts of the USDA’s Interim Final Rule on Establishment of a Domestic Hemp Production Program (hereinafter, “IFR”) with respect to their businesses’ planning and operations, as well as investments, risks, and other market factors that are determinants of industry viability. That information from our members is the basis for our comments on the IFR, presented below.
Sampling and Testing Procedures
a. 15 Day Pre-Harvest Window
The IFR’s requirement that sampling occur within a 15 day window prior to harvest is unreasonable, impractical, and unsupported by any scientific or policy rationale. In fact, requiring farmers to predict and commit to a 15 day pre-harvest window is problematic not just for hemp but for any crop, especially when grown outdoors. Inclement weather can and regularly does force farmers to harvest crops early, without 15 days advance notice. The IFR’s requirement has the effect of forcing hemp growers to choose between risking the loss of their crops to an adverse weather event or risking the loss of their crops’ entire value due to non-saleability for failure to comply with the pre-harvest testing requirement. Furthermore, even when such pre-harvest planning is possible, virtually every state, including Minnesota, lacks the capacity to collect samples, test them, and return results to growers within a 15 day window.
Recommendation: USDA should revise the IFR to permit states to establish their own requirements for pre- or post-harvest sampling and testing so long as those requirements comply with the mandates of the 2018 Farm Bill.
As a less preferred alternative, the USDA should revise the IFR to expand the pre-harvest sampling window to 30 days and provide authorization for growers to harvest their crops once a sample has been taken even if testing has not yet been completed.
b. Lot Requirements
The requirement that every lot be sampled and tested is also unreasonable and unsupported by any scientific or policy rationale, and presents a deviation from comparable regulatory norms and, most importantly, is counterproductive to the ability of states to provide adequate oversight.
The 2018 Farm Bill explicitly authorizes the use of random, risk-based sampling, which is the normal approach authorized and used under most federal and state regulatory frameworks that require compliance testing and inspections including for products and activities that have significantly more salient health and safety risks than cultivation of industrial hemp. Requiring states to sample and test every lot will tie up and limit state agencies’ administrative capacity and resources and compromise their ability to provide more comprehensive and proactive oversight of the industry through such activities as providing technical assistance to growers to support their compliance with regulations or generating and disseminating knowledge and information to growers about best practices and plant varieties to ensure THC concentrations below 0.3%.
Furthermore, states’ capacity to conduct sampling and testing should not be burdened when other controls exist to provide reasonable certainty of compliance with the federal THC threshold. There already exist hemp seed varieties for grain, fiber, and oil production that are well established and internationally certified as reliably producing plants with a THC content under 0.3% and such seed varieties will also be commercially available soon for CBD producing plants.
The requirement for sampling and testing every lot will be particularly burdensome for nurseries and indoor cultivation operations that have continuous planting and harvesting cycles and, as such, would also require continuous sampling and testing. Indeed, plants that are cultivated indoors are considerably more stable and reliable with respect to their THC content because of the ability to control environmental factors that can affect THC production in plants that are grown outdoors.
Recommendation: The USDA should revise the IFR to authorize the use of random, risk-based sampling supported by data. The IFR should also be revised to authorize states that adopt seed certification programs for cultivars that reliably produce a THC content under 0.3% to exempt such cultivars from sampling and testing requirements.
c. Sampling Guidance
The guidance documents issued by the USDA regarding sampling procedures specify that only floral material from the top third of the plant should be collected as a sample. Because THC is concentrated most in the flowers and buds of a plant, this approach will result in resting results that misrepresent the THC content of the plant and the marketable products that are to be produced from it because such products are almost always made from a composite of all plant parts.
Recommendation: USDA’s guidance on sampling procedures should specify the collection of a whole plant sample that includes flower, stalk, and leaves.
d. THC Testing Procedures
The 2018 Farm Bill explicitly authorizes testing for delta-9 THC using “post-decarboxylation or other similarly reliable methods,” yet the IFR mandates the use of methods for which “THC concentration levels reported accounts for the conversation of delta-9-[THCA] into THC.” As such, the IFR mandates that only testing methods that rely on post-decarboxylation be used, effectively nullifying the statutory language and Congressional intent that other similarly reliable methods of testing that do not require the conversion of THCA to THC be authorized.
Recommendation: USDA should revise the IFR to authorize the use post-decarboxylation or other similarly reliable testing methods as is the Congressional mandate under the 2018 Farm Bill.
e. DEA-registered Testing Lab Requirement
Among the most problematic and concerning requirements in the IFR is the requirement that only DEA-registered labs are authorized to test hemp plant samples to determine their THC content. There is a grossly insufficient amount of DEA-registered lab capacity available to meet the testing burden that exists even under most states’ industrial hemp pilot programs, not to mention the massively larger testing burden created under the IFR’s requirements. The requirement for DEA-registered lab testing in combination with the IFR’s other requirements for sampling and testing every lot within a 15 day pre-harvest window is a guaranteed to create a bottleneck that can bring the entire industrial hemp industry in the United States to a screeching halt.
The requirement for testing of hemp by a DEA-registered lab is also problematic because it violates both the letter and the spirit of the law established by the 2018 Farm Bill. In passing the 2018 Farm Bill, Congress acted specifically and enacted explicit statutory language to remove hemp from under the regulatory authority of the DEA and delegate sole regulatory authority over industrial hemp production to the USDA and FDA. The DEA has no statutory authority under the Controlled Substances Act or any other statute to regulate any legal agricultural commodity, including hemp. DEA’s authority is only triggered after a plant or product has been tested and established as meeting the statutory definition for marijuana based on its THC content. The public policy intent of Congress in removing industrial hemp from the auspices of the Controlled Substances Act and the DEA was to establish it as a licit agricultural commodity from which to grow a new, robust, and competitive industrial sector serving existing and new markets for licit products and services. Under the IFR, the USDA runs afoul of its regulatory obligation under the 2018 Farm Bill because it prioritizes the DEA’s goal of diverting illicit marijuana production ahead of Congress’ goal to establish an adequate regulatory framework to support the development of industrial hemp.
Recommendation: USDA should revise the IFR to use ISO 17025 accreditation as the qualifying technical benchmark for testing labs.
a. Negligent and Criminal Violations
The 2018 Farm Bill defines two types of violations and related enforcement actions: (1) negligent violations for which corrective actions are available and which are not subject to any criminal enforcement actions and (2) violations “with a culpable mental state greater than negligence” which must be reported to law enforcement for possible criminal enforcement. The IFR adopts an uncertainty measure that raises the THC content threshold for a negligent violation to 0.5% “if the hemp producer has made reasonable efforts to grow hemp.” (emphasis added) This is a small but insufficient step in the right direction for shielding growers from regulatory enforcement actions for violations that are not the result of their negligence, but it is a huge step in the wrong direction for shielding growers from criminal enforcement actions for violations that are not the result of their intent to violate the law.
With respect to shielding growers from invalid negligent violations, there is no statutory, policy, or scientific basis for capping that uncertainty measure and the resulting THC threshold for negligence at 0.5%. Data reported from across states with industrial hemp pilot programs establish that the vast majority of hemp samples that are tested and found noncompliant contain less than 1% THC which is well within the range of variance attributable to environmental and production factors that are beyond the control of any intentional or negligent acts or omissions by the grower.
The bigger problem, however, is that the IFR leaves not only the possibility but, rather, supports the inference that hemp with a THC content that tests above 0.5% may be the product of a grower who is attempting to grow illicit marijuana intentionally. Congress’ intent as expressed in the Farm Bill is clear--its goals are (a) to incentivize licensed hemp growers with good intentions to exercise due care for compliance with the regulatory requirements for hemp production and (b) to stop licensed hemp growers with insidious intentions from growing illegal marijuana under the guise of legal hemp production. This latter goal is best served by setting the THC threshold for possible criminal enforcement to a level of potency that corresponds at least somewhat reasonably to the THC potency of marketable illicit marijuana which, based on the DEA’s own testing data from illegal marijuana they have seized, is around 11% at the lowest end.
Setting THC thresholds that track more accurately to what the actual data show as the thresholds for negligent and intentional acts is critical to the ability of hemp producers, who inherently face a high risk of loss, to attract and maintain investments by mitigating at least some of that risk through insurance, which typically will not cover losses that are the result of negligence or criminal action.
Recommendation: The USDA should revise the IFR to set the THC content threshold for negligent violations to at least 1% and for reporting to law enforcement to at least 11%.
b. Destruction, Disposal, and Mitigation
IFR calls for the “destruction” of plants in excess of 0.3% THC while the 2018 Farm Bill only calls for the “disposal” of such plants. Both under its dictionary definition and as defined in other federal and state statutes and regulations, “disposal” encompasses throwing away or transforming unwanted waste or byproducts. Considering, as stated above, that the majority of noncompliant hemp samples test under 1% THC and that the THC potency of illicitly grown and marketed marijuana is 11% at a minimum, the requirement to destroy noncompliant hemp plants with absolutely no psychoactive properties is an enormous waste of human, capital, financial, and resource investment with no legal or public policy justification. Noncompliant hemp plants can be utilized or their THC content mitigated such that all or some of their value is retained. For example, such plants could be tilled into mulch, blended with lower THC plants to reduce aggregate THC content to acceptable levels, or processed to remove excess THC that then can be separately disposed of, transferred to a DEA-registered research facility, or otherwise dealt with in accordance with state and/or federal law.
Recommendation: The USDA should accept a state’s plan for mitigating noncompliant plants subject to the 2018 Farm Bill’s requirement for “disposal.”
3. Hemp Seed Genetics and Plant Breeding
Consistent with the merits of risk-based sampling explained in section 1(a) above, states’ capacity to conduct sampling and testing should not be burdened when other controls exist to provide reasonable certainty of compliance with the federal THC threshold. Indeed, the greatest certainty of compliance will come from the innovation of more hemp plant varieties with a reliable THC content below 0.3% (such as those that already exist for grain, fiber, and oil) through seed genetics and plant breeding. Unfortunately, all of the challenges and problems that the IFR creates for hemp growers generally are especially salient for producers who grow hemp specifically for the purposes of plant breeding and seed genetics. The process of developing seeds and plants that produce specific desirable properties involves continuously growing and harvesting a large number of plants of many different varieties, each of which constitutes a separate lot that must be sampled and tested at a pace that is often accelerated due to the lack of a necessity for plants to reach maturity before being harvested for use.
Additionally, the process of innovating new plant varieties that have desirable traits like pest-, disease-, or drought-resistance combined with a THC content below 0.3% is likely to produce some intermediary parent varieties that incidentally have a high THC content. The considerably high risk of facing regulatory and, especially, criminal enforcement actions for knowingly growing potentially hot plants may well have a chilling effect on the innovation of plant varieties with desirable traits and, as a consequence, result in monoculture farming of plants with particularly high pest and disease risks.
Recommendation: The USDA should develop a set of regulatory provisions specifically for hemp plants that are grown exclusively for the purpose of developing new plant varieties through breeding and genetics and will not ever enter the stream of commerce or be converted into any products that enter the stream of commerce.
We thank you for your consideration of these comments. We hope that the issues we have identified and our recommendations for their resolution provide value and are reflected in changes to the IFR and, ultimately, in the promulgation of the Final Rule.