Did you hear that the USDA is close to releasing their Hemp Regulations? We have a copy of the draft. This draft affects the whole community. We have broken down the main portions for your convenience.
The interim final rule on hemp will be formally published in the Federal Register on Thursday, with a 60-day public comment period to follow. Once the rules are finalized, USDA will begin to evaluate states’ and tribes’ submitted regulations plans, and any jurisdictions that do not send proposals will fall under the department’s general guidelines for producing the crop.
The regulations cover the requirements for where hemp can be grown, THC testing standards, the disposal process for crops that don’t meet federal standards and licensing protocols.
The draft does not address whether smokable hemp flowers may be sold. The absence of specific rules doesn’t necessarily indicate that USDA is permitting smokable hemp but the lack of clarity on the issue leaves room for a solution by states.
USDA Hemp Regulations Sample & Testing
USDA is simultaneously issuing separate guidelines for sampling and testing procedures for hemp. Samples, which have to be collected up to 15 days prior to a crop’s anticipated harvest date. If farmers delay harvest beyond 15 days, the plant will likely have a higher THC level at harvest than the sample that is being tested.
Testing procedures must ensure the testing is completed by a DEA-registered laboratory using a reliable methodology for testing the THC level. The THC concentration of all hemp must meet the acceptable hemp THC level. Samples must be tested using post-decarboxylation or other similarly reliable analytical methods where the total THC concentration level reported accounts for the conversion of delta-9-tetrahydrocannabinolic acid (THCA) into THC.
Lab Testing Facilities
Testing procedures must ensure the testing is completed by a DEA-registered laboratory using a reliable methodology for testing the THC level.
We see this as farmers are not allowed to own a lab testing facility.
Laboratories should meet the AOAC International standard method performance requirements for selecting an appropriate testing method.
The interim rule requires that laboratories report the measurement of uncertainty as part of any hemp test results. The rule also includes a definition of “acceptable hemp THC level” to account for the uncertainty in the test results. The reported THC concentration level of a sample may not be the actual concentration level in the sample.
USDA is considering requiring all laboratories testing hemp to have ISO 17025 accreditation
The laboratories conducting hemp testing must be registered by the DEA to conduct chemical analysis of controlled substances (in accordance with 21 CFR 1301.13). Registration is necessary because laboratories could potentially handle cannabis that tests above the 0.3% the concentration of THC on a dry weight basis, which is, by definition, marijuana and a Schedule 1 controlled substance.
Instructions for laboratories to obtain DEA registration, along with a list of approved laboratories, will be posted on the USDA Domestic Hemp Production Program website at a later date.
“For example, if the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%, the measured delta-9 tetrahydrocannabinol content concentration level on a dry weight basis for this sample ranges from 0.29% to 0.41%, Because 0.3% is within the distribution or range, the sample is within the acceptable hemp THC level for the purpose of plan compliance.”USDA Statement
If the THC content is found to be unacceptable, however, it must be destroyed by someone authorized under the Controlled Substances Act to handle marijuana, such as a DEA registrant. A USDA official confirmed on a press call Thursday that hemp that falls outside of the acceptable THC level will not be covered by federal crop insurance.
Felony Drug Convictions
One topic of interest for advocates is the implementation of a 10-year ban on participation in the hemp industry by individuals with prior felony drug convictions.
State and Tribal plans also must prohibit any person convicted of a felony related to a controlled substance under State or Federal law before, on, or after the enactment of the 2018 Farm Bill from participating in the State or Tribal plan and from producing hemp for 10-years following the date of conviction. An exception applies to a person who was lawfully growing hemp under the 2014 Farm Bill before December 20, 2018, and whose conviction also occurred before that date.
To meet this requirement, the State or Indian Tribe will need to review criminal history reports for each applicant. When an applicant is a business entity, the State or Indian Tribe must review the criminal history report for each key participant in the business.
This does not include other management positions like farm, field or shift managers. USDA is requiring a criminal history records report for key participants because those persons are likely to have control over hemp production, whether production is owned by an individual, partnership, or a corporation.
The State and Tribe may determine the appropriate method for obtaining the criminal history report for their licensees in their plan. Finally, any person found by the USDA, State, or Tribal Government to have materially falsified any information submitted to this program will be ineligible to participate.
Licenses do not renew automatically and must be renewed every three years.
Once the regulations are finalized, hemp farmers will be eligible for a series of federal agriculture programs, including crop insurance.
All plans submitted for USDA approval must also have a certification stating the State or Tribe has the resources and personnel necessary to carry out the practices and procedures described in their plan.
During the plan development process, States and Tribes are encouraged to contact USDA so we may provide technical assistance in developing plan specifics. USDA will not review, approve or disapprove plans until after the effective date of this interim rule.
Once USDA formally receives a plan, USDA will have 60 days to review the submitted plan. USDA may approve plans which comply with the 2018 Farm Bill and with the provisions of this rule. If a plan does not comply with all requirements of the Act and this part it will be rejected.
All hemp produced outside of the United States must meet the requirements of the USDA. The USDA will begin accepting applications 30 days after the effective date of this interim rule.
USDA Hemp Seed Rules
Under the hemp pilot program authorized under the terms of the 2014 Farm Bill, various States developed seed certification programs to assist producers to identify hemp seed that would work well in their specific geographical areas. USDA will not include a seed certification program in this rule because the same seeds grown in different geographical locations and growing conditions can react differently.
For example, the same seed used in one State to produce hemp plants with THC concentrations less than 0.3%, can produce hemp plants with 10 THC concentrations of more than 0.3% when planted in a different State.
We have also found that the technology necessary to determine seed planting results in different locations is not advanced enough at this time to make a seed-certification scheme feasible. Additionally, we do not have accurate data at this time on the origin of most hemp seed planted in the U.S.
The department also clarified the rules on importing and exporting hemp seeds and plants this month. The interim rule states that it “does not affect the exportation of hemp” and notes that USDA will work with partners on an exportation plan if there’s sufficient interest.
The requirements for importing the full plant from Canada are different than for other countries. Plants from Canada are allowed if they’re “accompanied by a phytosanitary certificate from Canada’s [national plant protection organization” to verify the origin of the plant and to confirm no plant pests are detected.” For other countries, importers must fill out an additional permit application.
Companies can also import hemp seeds from Canada if they produce a “Federal Seed Analysis Certificate”.
In addition to a certificate, those who seek to import seeds from countries other than Canada are subject to a Custom and Border Protection inspection at the port of entry in order “ensure they meet [Animal and Plant Health Inspection Service] regulations, including certification and freedom from plant pests.”
Lawmakers are still pushing the FDA to issue rules for CBD products. The agency said their rulemaking process is complicated by the fact that CBD exists as an FDA-approved drug and hasn’t been previously added to the food supply.
Those interested in becoming producers or operating a testing facility can find guidance and forms here and here. USDA also published their updated FAQ on hemp. Click here to view and download the full regulations in PDF format.