USDA’s Hemp Regulations Create Challenges for Hemp and CBD Producers – Lexology

On October 31, 2019, the United States Department of Agriculture (USDA) unveiled the interim final rule for its U.S. Domestic Hemp Production Program, and may now proceed with review and approval of state and tribal hemp plans. The release commenced a public comment period that has recently been extended through January 29, 2020, and the USDA will publish finalized rules within two years. Although hemp may continue to be cultivated pursuant to authority granted by the 2014 Farm Bill, that authority sunsets on October 31, 2020, one year after the publication of the interim rule.

Initial public reaction to the interim regulations has been generally pessimistic. Producers of hemp complain that the testing and compliance requirements are too strict and that if implemented the interim rule may stunt industry growth. In particular, many are concerned with the USDA’s definition of the 0.3% THC limit for legal hemp, restrictive testing methodologies under a new federal testing standard, and a new requirement that all testing labs be DEA-certified, which may result in inadequate testing capacity to meet demand.

USDA Hemp Producer License

The USDA will begin accepting applications 30 days after the effective date of its interim rule. It will not accept applications from licensed hemp producers (producers) whose states have already submitted a plan, which thus far includes Arizona, Georgia, Kentucky, Montana, North Dakota, Oregon, Pennsylvania, Tennessee, Texas and Wyoming.

During the first year, applications can be submitted at any time. Afterward, license applications and license renewal applications must be submitted between August 1 and October 31. All applications will require basic contact information and a completed criminal history report for each key participant. Applicants who are rejected may appeal. Applicants who have been convicted of a felony related to a controlled substance in the past 10 years will not be granted a license.

Licenses do not renew automatically and must be renewed every three years. Licenses will be valid until December 31 in the final year before the producer’s license expires. Producers are required to immediately report their crop acreage to the USDA Farm Service Agency (FSA) and provide the specific geospatial location where the hemp is produced. Producers must notify the USDA immediately following any change to the information provided on the license application.

State and Tribal Hemp Plans

The USDA has reiterated that the 2018 Farm Bill preempts any state law designed to restrict hemp in interstate commerce. The 2018 Farm Bill specifically “allows for the interstate transportation and shipment of hemp in the United States.” The new regulations, however, contain no explicit language or direction for what documents or information should be included within shipping manifests for hemp or hemp-derived products that are transported in interstate commerce.

States and tribes are allowed to submit their own hemp regulatory plans for USDA approval so long as the plans are more stringent than the USDA’s rule. State plans must include procedures for documenting where each Producer grows its hemp; sampling, testing and disposal of noncompliant plants; and compliance. The USDA has 60 days to approve a state’s plan after submission. If a plan is approved, it will remain in effect unless revoked by the USDA at a later date. If a plan is rejected, the USDA will provide a letter outlining the plan’s deficiencies. States have the option to submit an amended plan upon rejection. If an approved plan later requires amendment because of a state’s legislative or regulatory changes, the amended plan must be submitted for approval.

A state that initially elects to authorize hemp production pursuant to the USDA plan may submit its own plan at a later time. Once a state begins to issue its own licenses, any previously granted USDA license becomes invalid.

Documenting Where Hemp Is Cultivated

Each plan must contain a process to track the land where hemp is cultivated. All information regarding hemp production sites must be collected and stored for three years. Producers must disclose a description of their land and provide geospatial locations for each field, site or greenhouse where the producer intends to grow hemp. Producers also must report their hemp crop acreage to the FSA.

Sampling, Testing and Disposal

State plans must include procedures for sampling and testing to ensure that each harvest does not exceed a THC concentration of 0.3% on a dry weight basis. Producers must deliver their samples to a DEA-registered lab for testing 15 days before the anticipated harvest date. For crops on less than one acre, producers are required to provide a cutting from a single plant as a sample. For crops on between two and 10 acres, producers must provide one plant per acre, take cuttings of each selected plant and combine the cuttings to form a composite sample. For crops over 10 acres, the USDA has supplied a complex formula to determine an appropriate sample size for testing. Designated federal or state inspectors will personally collect a representative sample from each producer’s crop 15 days before the anticipated harvest.

Samples must be tested using “post-decarboxylation” or “similar analytical methods” such as gas or liquid chromatography with detection. Each method is designed to report the total THC concentration level after its conversion from delta-9 tetrahydrocannabinol THCA to THC. The total THC derived from the sum of the THC and THCA content shall be reported on a dry weight basis.

The rule’s total THC requirement is expected to cause widespread disruption for many current participants in the industry. A majority of the state hemp regulations currently in place require only a delta-9 THC concentration. Total THC concentration is an entirely different standard that will limit the hemp varieties that farmers may legally grow. Many hemp varieties that are currently being cultivated pursuant to the authority of the 2014 Farm Bill, and which test below 0.3% THC concentration using test methods that only measure delta-9 tetrahydrocannabinol, will no longer be legal under the 2018 Farm Bill as a result of the total THC requirement for determining THC concentration.

The gas chromatography test recommended under the rule also has been criticized by the hemp industry because it tends to increase the THC concentration in hemp samples and can raise the concentration over the 0.3% limit. A sample that originally contains a compliant THC concentration may ultimately test above the limit because the gas chromatography test is designed to heat the sample at temperatures high enough to alter its molecular structure. An inaccurate result can trigger mandatory immediate disposal of an entire crop, especially if the concentration is revealed to be 0.5% or higher, and could lead to the suspension and possible revocation of a producer’s license.

The USDA will require that all testing labs be registered by the DEA. The USDA’s website will contain a list of approved DEA-registered labs. The labs are required to report the combination of each sample’s total THC concentration level and the “measurement of uncertainty” when reporting THC test results. The measurement of uncertainty will create a distribution range that will help determine if the sample is 0.3% or lower. So long as the sample’s distribution range contains 0.3% or less THC content, the sample will be acceptable. Any test result that shows a 95% confidence that the sample’s THC content is higher than 0.3% shall be conclusive evidence that one or more plants are noncompliant. A producer may request a retest at the producer’s expense if it believes the original test results were in error. Any hemp that exceeds the acceptable THC level must be disposed of in accordance with DEA regulations. Labs are required to share test results from the producer with the USDA.

Compliance and Audits

Producers in different states are scrambling to adjust and comply with the interim federal regulations. Compliance with the allowable THC concentration in hemp will be the biggest challenge for the industry as a whole. Many states already have established their own acceptable THC concentrations. For example, in Vermont, the allowable THC concentration is 1%, which is more than three times the allowable limit under the federal law and 50% higher than the 0.5% negligent violation threshold. The 0.5% threshold is especially worrisome because it could lead to the suspension and possible revocation of a producer’s license.

How a particular cannabis plant reaches certain THC concentration levels is not totally understood and the science remains in its infancy. Although the USDA acknowledges the difficulty with growing hemp within the requisite THC concentration levels, the current interim compliance rules and regulations seem to have been drafted with a heavy emphasis on external enforcement with bright-line levels of acceptable THC.

The USDA has divided compliance into two separate categories: general audits to ensure compliance and corrective plans for those licensees who have been issued negligent violations. It is important to note that while negligent violations will not result in criminal prosecution, they can lead to a suspension or revocation of a license.

The new rules also establish two types of audits: a desk-audit and an on-site visit to the licensee’s facility to ensure compliance. The USDA explicitly states that “USDA will conduct an audit of all USDA licensees no more than every three years based on available resources.” Interestingly, the USDA did not provide any guidance as to which facilities will be audited in person and which will simply receive a desk-audit.

Desk-Audit As

its name suggests, a desk-audit gives the USDA authority to request records kept by the licensee. The requested records will include production and planting data, testing results and the catch-all category of “other information as determined by USDA.”

On-Site or Inspection Audits

The interim rules state that the USDA is granted access to “any fields, greenhouses, storage facilities, or other locations where the licensee produces hemp.” What has not been established is the duration of the on-site audits or any notice provided to the licensee before the onsite audit.

Violations and Corrective Action Plans

As stated above, a producer can be issued a negligent violation if the THC concentration of the plant exceeds 0.5%. In determining whether a violation occurred, the interim rules state that a failed test from a distinct lot may invalidate the entire harvest. The rules do not state what defines a “distinct lot.”

The USDA is aware that determining THC concentration is not an exact science and that uncertainty exists prior to testing. In response, the USDA has established corrective action plans for those producers who are issued violations. The violating producer will receive a notice of violation that will include a corrective action plan. Although it is yet to be determined how intensive these correction action plans will be, the interim rules state that the plan will include a reasonable date by which the producer shall correct the violation. The producer may be required to report “periodically” to the USDA on its compliance with the plan for a period of not less than the next two calendar years. Habitual violators are subject to being ineligible to produce hemp for a period of time. For example, three negligent violations in a time span of five years will result in a five-year moratorium on hemp production for that producer.

Failure to comply with the corrective action plan may lead to a suspension or revocation of a producer’s license. The USDA has set a bright-line rule that a producer’s license will be revoked if the producer is convicted or pleads guilty to a felony for possession of a controlled substance, knowingly makes false statements to USDA officials, knowingly grows cannabis exceeding the acceptable THC level, or negligently violates the acceptable THC level three times in a five-year period.

The USDA also reserves the right to report violating producers of THC levels above 0.5% to the attorney general and state law enforcement.

Duty to Report to Farm Service Agency

Similar to more traditional farming, hemp producers are required to provide data to FSA regarding hemp crop acreage, and specific information regarding field acreage, greenhouse or indoor square footage of hemp planted. The USDA intends to use this information to assemble and maintain a database for hemp production throughout the country.

What Comes Next?

While the initial reaction to the interim rules has been generally negative, the 60-day public comment period may result in the loosening of some of the regulations. The USDA readily admits that testing for THC concentration is susceptible to error, which is currently managed under the proposed regulations by a margin of error allowance. The individual states should work with the USDA during the public comment period to determine what acceptable testing and sampling procedures should be implemented in the final interim rule. Another question that demands clarity is whether the requirement of all testing to be performed by DEA-certified labs will create inadequate testing capacity to meet anticipated demand.

Note: This article appeared in the December 19, 2019, edition of PropertyCasualty360 Daily News.

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