On October 29, 2019, the U.S. Department of Agriculture (USDA) released their draft interim final rule relating to the production and cultivation of hemp. This rule can be found here: https://www.ams.usda.gov/rules-regulations/hemp.

The interim final rule on hemp was officially published in the Federal Registrar on October 31, 2019 and will be finalized following a 60-day public comment period. After this period is complete, the interim rule will be in-place for a period of 2 years at which point the USDA will issue final regulations. Additionally, after the 60-day public comment period has commenced, the USDA will begin to evaluate regulatory plans for any jurisdictions (state or tribe) that wished to self-govern their hemp industry. Any state or tribe whose plans are rejected, or otherwise do not send in proposals related to self-governance, will be regulated directly under the USDA’s interim final rules. The USDA has stated that all determinations on state or tribal applications will be made within 60 days of their submission. If a jurisdiction opts to adopt the USDA interim final rules directly, the application will be reviewed within 30 days of submission.

The USDA also released separate, supporting guidelines related to sampling and testing procedures for hemp. These guidelines can be found through the following link: https://www.ams.usda.gov/rules-regulations/hemp/information-laboratories.

A summary of the key considerations for these processes is detailed below.

Sampling

Samples are intended to be representative of each “lot of hemp crop acreage identified by the producer”. A “lot” is defined by the USDA to refer to a single “contiguous area in a field, greenhouse, or indoor growing structure”, which contains the same variety or strain of cannabis throughout. Additionally, a “lot” refers to the batch of whole product being sold to “a single buyer at a single time”. This lot is mandated to be defined by the producer in terms of farm location (in GPS coordinates) and field acreage in documentation.

The most crucial difference between the current sampling process and the new rules proposed by the USDA is the requirement that all samples be taken by a “sampling agent”, which is classified as “an approved Federal, State, local, or Tribal law enforcement agency or other State or Tribal person”. This is in comparison with processes found in many state cannabis regulations where lab employees are required to perform the sampling directly.

All sampling must occur within 15 days prior to anticipated harvest of cannabis plants, in order to ensure that the sample taken is representative of the final product. At this point, the sample is sent to a “qualified, DEA-registered laboratory”.

Testing

All laboratories which wish to test hemp must be registered with the DEA to handle controlled substances under CSA and DEA regulations (specifically 21 CFR part 1301). Registration forms for this process can be found through the following link: https://www.deadiversion.usdoj.gov/drugreg/index.html. The related form for a new application is DEA Form 225 related to Analytical Laboratories.

The USDA is also considering requiring that all hemp compliance laboratories be approved by the USDA. This process would occur through the USDA, AMS, Laboratory Approval Service which is responsible for the Laboratory Approval Program (LAP). Most notably, this program would require ISO 17025 accreditation in addition to the USDA’s own accreditation process. These rules can be found here: https://www.ams.usda.gov/services/lab-testing/lab-approval.

Furthermore, while the rules do not currently require laboratories to be ISO 17025 accredited, the USDA is considering adding this provision directly to the interim final rules depending on feedback given during the public comment period. Public comments can be submitted here: https://www.regulations.gov/document?D=AMS_FRDOC_0001-1919. All comments must be submitted prior to December 30, 2019.

Laboratory testing is mandated to the following general procedure:

1. Laboratory receives sample.
2. Dry sample to remove the majority of water.
3. Mill and “manicure” sample though a wire screen no larger than 1.5 x 1.5mm to discard mature seeds and larger twigs and stems.
4. Separate sample into a test and retain specimens.
   1. Test specimen: go to step 5
   2. Retain specimen: package and store until needed. When needed go to step 5.
5. Determine moisture content or dry to a consistent weight (meeting criteria).
6. Perform chemical analysis.
7. Calculate total THC on a dry weight basis. Test results should be determined and reported on a dry weight basis.

The USDA mandates that laboratories test Total THC by using a post-decarboxylation or other similar method. Current techniques which are acceptable by the USDA for this purpose are gas chromatography and high-performance liquid chromatography, though acceptable methods are not limited to these. This is in order to ensure that the total THC concentration level takes into account any conversion of THCA into THC during the post-harvest period.

In order to select an appropriate method, all laboratories are required to meet the AOAC International standard method performance requirements (SMPR). These requirements can be found through the following link: https://www.aoac.org/resources/smpr-2019-003/.

Additionally, and concurrently, AOAC International has submitted a Call for Methods which are suitable and meet the performance requirements mandated by AOAC SMPR 2019.003. These methods can be submitted to AOAC prior to January 17^th 2020 through the following link: https://www.aoac.org/news/call-for-methods-cannabinoids-in-plant-materials-of-hemp/.

All test methods need to account for uncertainty, with a sample being labelled as a “Pass” if it is proven that, at a 95% confidence level, no more than 1% of the plants in the lot exceed 0.3% Total THC on a dry-weight basis.

Other Key Mandates

Below please find a list of other key mandates to consider:

• All Jurisdictions with approved hemp plans must report all contact information and licensee statuses (as well as a list of all nonconforming plants and the disposal statuses of these plants) to the USDA on the first of each month.
• No jurisdiction may prohibit the transportation of any hemp or hemp products that have been legally produced.
• All jurisdictional hemp plans must include regulations related to negligent violations by any producers, and the correction of these violations.
• States may enact more stringent requirements if they wish.

These regulations do not consider any unique requirements related to CBD and other hemp-derived cannabinoids in food, supplements, or other similar products. This is due to the wording of the 2018 Farm Bill, which puts these products under the authority of the U.S. Food and Drug Administration (FDA). The FDA is currently being pushed by key members of congress to develop these new regulations as swiftly as possible, but have not expressed a timeline for when these rules can be expected [4].

Citations and Resources

1. “Alerts & Updates.” Duane Morris LLP – USDA Releases Long-Awaited Federal Rules on Hemp Production, but State-by-State Regulatory Differences Remain, 2019, www.duanemorris.com/alerts/usda_releases_long_awaited_federal_rules_hemp_production_state_differences_remain_1019.html.
2. “Call for Methods: Cannabinoids in Plant Materials of Hemp.” AOAC International, www.aoac.org/news/call-for-methods-cannabinoids-in-plant-materials-of-hemp/.
3. “Establishment of a Domestic Hemp Production Program.” Regulations.gov, 2019, www.regulations.gov/document?D=AMS_FRDOC_0001-1919.
4. Jaeger, Kyle. “USDA Releases Proposed Hemp Regulations For Public Comment.” Marijuana Moment, 29 Oct. 2019, www.marijuanamoment.net/usda-releases-proposed-hemp-regulations-for-public-comment/.
5. “Laboratory Approval and Accreditation.” Laboratory Approval and Accreditation | Agricultural Marketing Service, www.ams.usda.gov/services/lab-testing/lab-approval.
6. “More Senators Are Demanding the FDA Speed up CBD Regulations – The Boston Globe.” BostonGlobe.com, The Boston Globe, 10 Oct. 2019, www.bostonglobe.com/news/marijuana/2019/10/10/more-senators-are-demanding-fda-speed-cbd-regulations/r1he975ngiz2P7itOESryI/story.html.
7. “REGISTRATION.” Registration, www.deadiversion.usdoj.gov/drugreg/index.html.
8. “SMPR 2019.003.” AOAC International, www.aoac.org/resources/smpr-2019-003/.
9. “Title 21 Code of Federal Regulations.” PART 1301 – Section 1301.13 Application for Registration; Time for Application; Expiration Date; Registration for Independent Activities; Application Forms, Fees, Contents and Signature; Coincident Activities, www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_13.htm.
10. “U.S. Domestic Hemp Production Program.” U.S. Domestic Hemp Production Program | Agricultural Marketing Service, 2019, www.ams.usda.gov/rules-regulations/hemp.