Analysis & Commentary on the USDA Interim Hemp Rules 

 

as published by the USDA on the Federal Register - October, 31st 2019

This is a general analysis and breakdown of the interim hemp rules as published on the Federal Register in October 2019. This is not legal advice or any form of legal analysis, it is, however, some analysis and commentary of the implications as they impact the hemp industry. Separate guidelines for sampling and testing were also provided by the USDA and published on their website. These guidelines are worth reading, are written plainly, and in a format so as not to warrant a separate overview. For reference, we have linked to those published guidelines as we offer some commentary on those as well. 


Supporting documents: 

Official Federal Register publication of the USDA Hemp Production Interim Hemp Rules

USDA Hemp Sampling Guidelines  

USDA Hemp Testing Guidelines 

USDA Information for Hemp Producers 


USDA Hemp Program FAQ 

At the end of this page is a condensed list of definitions as published by the USDA. We highly recommend reading through some of those definitions, considering the implications they have. 

Use the following links to skip to any portion of this page:
OVERVIEW
- REGULATION PLANS
- LICENSING

- REGULATORY COMPLIANCE
- TESTING AND SAMPLING
- SEEDS

ANALYSIS AND COMMENTARY
- REGULATION PLANS

- LICENSING
- REGULATORY COMPLIANCE
- TESTING AND SAMPLING
- SEEDS
- OTHER VITAL ANALYSIS AND COMMENTARY

DEFINITIONS

DISCLAIMER

Overview - Key Points

 

HEMP REGULATION PLANS

  • The USDA has set provisions for States and Tribes to create their own hemp regulation plans, if they wish to do so. 

  • These plans must be approved by the USDA through a submission process. The State or Tribal plans can be more strict or stringent than the USDA rules, but cannot be less restrictive.

  • Even if a State or Tribe bans the sale or production of hemp within their territory, they may NOT ban the transportation of hemp. 

  • The USDA will implement their own plan for States and Tribes that don't have their own approved plan.

  • Any plan submitted to the USDA must include a process for gathering information on State or Tribal license applications including criminal background and full contact information of a producer or business and its key officers, as well as all land planned for use in cultivating hemp such as legal description, geospatial location, and proposed hemp crop acreage of the land to be used. These reports must be kept for at least 3 years by any State or Indian Tribe.  

  • State and Tribal plans must include procedures for reporting to the USDA the full contact information about applicants including license or permit number and status, full business information, EIN number, names and titles of principal officers of a business. These records must be kept for at least 3 years.  

  • State or Tribal plans must include provisions for intentional, knowing, or reckless (culpable mental state) violations. The State or Tribal government must immediately report the producer to the USDA, the Attorney General, and the chief law enforcement officer for that State or Indian Tribe. The USDA plan will also have this provision. 

  • A State or Tribal government must report to the USDA certification that they have enough resources and personnel to carry out a proposed plan.  

  • States and Tribes can contact the USDA for guidance in creating a plan. The USDA will provide information about any deficiencies or issues with a plan that is rejected. A plan may be reconsidered by an appeal.  

  • An approved plan will stay in effect until is either revoked by the USDA, or a State or Tribe substantively changes or alters their plan or their laws such that would alter the way the plan meets these regulations. A plan must be amended and resubmitted for approval within 1 calendar year from any changes to State or Tribal law. Producers are held liable to be compliant with a previous plan until the USDA approves a new plan.  

  • All USDA approved State and Tribal plans will be published on the USDA website.  

  • The USDA can audit any approved State or Tribal plan for compliance. Upon the first issue of non-compliance with the approved plan, the USDA will work with that State or Tribe to develop corrective measures. Upon further non-compliance, the USDA may revoke that State or Tribe plan for one year, providing sufficient time for the State or Tribe to evaluate problems make changes.  

  • If a plan is revoked, it will be effective at the end calendar year to give producers time to adjust their business operations and have time to apply for a USDA hemp production license.  

  • Higher education States and institutions can continue to operate under the authority of the 2014 Farm Bill rules for 12 months from the effective date of this rule.  

  • The USDA will collect and aggregate information to share with other governmental agencies. 


LICENSING

  • If a State or Tribe has an approved plan in place, then a producer (grower/farmer/processor) within that State or Tribe can ONLY apply for a license to produce hemp or hemp products through the State or Tribe.

  • If a State or Tribe does NOT have an approved plan, a producer can apply for a license directly from the USDA.

  • No applications will be accepted by the USDA for the first 30 days of this ruling. States and Tribes will have this time to submit their own plans for approval by the USDA. Initially, the application process will be open for a year. After that, the application process will be from August 1st to October 31st on each subsequent year.

  • The license will be granted for a 3 year term and will NOT auto-renew. So, every 3 years, a processor must apply for a renewal.

  • Hemp producers must submit a report of hemp crop acreage, including a legal description and geolocation of any land or structures where hemp will be produced in their application for USDA, State or Tribal hemp license application.

  • All applications must include full contact details for individuals. For businesses, it must include full contact details for the business as well as details for each key officer of the business. This excludes management and only pertains to people who have key control over the business operations.  

  • The USDA, State, or Tribal plan must include provisions for conducting a criminal background check for all applicants. Anyone with a felony conviction relating to controlled substances in the past 10 years is barred from being able to produce hemp within a 10-year period starting from the date of conviction. An exemption occurs for someone who was legally growing hemp under the 2014 Farm Bill and before Dec 20, 2018 and who’s conviction was also prior to Dec 20, 2018. This also relates to any KEY position in any company or business producing hemp, meaning people who have key control over the business operations and as such, excludes management positions or below.

  • Criminal history reports run 60 days prior to an application will not be accepted. The report must show that any individual or key officer of a company has no State or Federal felony convictions related to controlled substances for a period of 10 years prior to the date of the report.  

  • If an application is denied, the USDA will inform the applicant specifically why it was denied and the applicant can appeal that decision within 30 days. If the application was denied for being incomplete, the applicant can resubmit the application. Applications can be resubmitted after Oct 31st as long as the original application was between Aug 1st and Oct 31st.  

  • Once an application is approved, no one can produce hemp without having first received their license. The license is non-transferable and is valid for 3 years. They do not automatically renew. The producer must submit an application for renewal at the end of their license term, subject to the same rules and reports as the original application.  

  • Anyone found by the USDA, State, or Tribal government to have materially falsified information during the application process will be barred from participation.  

  • If any of application information changes after it is approved, a license modification is required. This includes business ownership, geolocation, building changes, etc. Any such changes must be immediately reported to the USDA.

  • If there has been a change to the law or regulations after the approval of a license, that license will be valid til Dec 31st of the year that is at least 3 years after the approval of the original license. At that point, the new regulations or laws will govern the application for renewal. 

  • A license may be suspended for a period of one year if the USDA believes the producer has violated these provisions or failed to comply with a corrective action plan or written order from AMS. Examples being hemp grown outside of an approved location or harvested plants that were not tested.  

  • A suspended license may be restored after 1 year and the producer may be required to comply with a corrective action plan in order to restore their license.  

  • A USDA license may be immediately revoked if a producer pleads guilty to a felony related to controlled substances, was found to have made materially false statements to the USDA or its representatives with a culpable mental state, or willfully produced hemp that was above the acceptable THC limits, or had 3 negligent violations in 5 years.

  • License suspensions and revocations can be appealed within 30 days through the USDA or ruling authority (State or Indian Tribe).

 


REGULATORY COMPLIANCE

  • Federal law classifies hemp as cannabis that has a total Delta-9 THC concentration of 0.3% or less by dry weight.- 

  • This law states that ANY part of the plant or derivative thereof (tincture, oil, distillate, salt, acid, etc), growing or not, that has a total THC concentration above 0.3% is considered marijuana, and is therefore, a Schedule 1 controlled substance. This law excludes the mature stalk. 

  • The USDA further defines this by stating that total THC concentration will include the decarboxylation conversion of THCA into Delta-9 THC. 

  • In order to show compliance with this law, all hemp produced must be tested for THC concentration by a USDA approved lab. 

  • Any crop or product that has a THC concentration above 0.3% must be disposed of in accordance with the USDA approved State or Indian Tribal plan. Before disposal, there must be a degree of certainty that the THC concentration is accurately measured.  

  • A producer must use best practices and reasonably prudent efforts to ensure the hemp produced doesn’t exceed the acceptable THC levels. If hemp produced has a THC concentration of above 0.3% but is at 0.5% or below, the producer will not be considered negligent. While the hemp product or crop will still be considered as a Schedule I Controlled substance, it will still need to be disposed of, according to the ruling authority (USDA, State, or Tribal plan).  

  • Negligent violations include failure to provide legal description of the land or facility where hemp is produced, producing hemp prior to obtaining a license, producing hemp plants that exceed the acceptable levels and is above 0.5% THC concentration.  

  • If a producer is found to have committed a negligent violation, then the ruling authority (USDA, State, or Indian Tribe) will establish a corrective action plan. This plan must include a date by which the negligent violation will be corrected by the producer. During this plan, the producer must periodically report back to the ruling authority (USDA, State, or Indian Tribe) with compliance for no less than 2 years following that violation. 

  • Hemp produced in a negligent manner is subject to mandatory disposal.  

  • Disposal must be done according to CSA (Controlled Substances Act) and DEA regulations.

  • If a producer is found to have committed a negligent violation 3 times within 5 years, that producer will be barred from producing any hemp products for a term of no less than 5 years from the date of the 3rd violation. 

  • Sampling and testing violations will be considered for the entire harvest from a unique lot. So, if 5 samples from distinct lots are above 0.5%, then that is only one violation. Producing hemp without a license is one violation.  

  • No criminal enforcement action will be taken by any local, municipal, State, Tribal, or Federal governmental agency against producers for negligent violations. 

  • To ensure compliance, the USDA may conduct an audit of any licensed hemp producer. The USDA will conduct an audit of all USDA licensed producers no more often than every 3 years. And the USDA will issue a summary of that audit to the producer.  

  • Violations done in a willful or intentional (in a culpable mental state greater than negligence) such as producing hemp without a license, will be reported to the Attorney General and chief law enforcement agency of the State or Tribe.  

  • USDA producers with a notice of suspension may not handle or remove cannabis from their location at the time of said suspension without written authorization by the USDA. They are also prohibited from producing hemp for the duration of the suspension. 

  • All licensed producers must submit a report of hemp crop acreage, including a legal description and geolocation of any land or structures where hemp will be produced to the FSA along with their hemp license or authorization number. 

  • All licensed producers must retain records and reports for at least 3 years. This includes all FSA reports as well as demonstrated compliance with plans or programs, and documented disposal. 


TESTING and SAMPLING

  • All THC concentration compliance testing must be done by a USDA approved lab. 

  • In order for a lab to be USDA approved to perform THC concentration testing, it must have DEA registration, as the lab may be handling materials that may contain THC concentrations greater than 0.3% and would, thusly, be considered marijuana, a Schedule 1 controlled substance. 

  • The USDA is considering implementing either a Laboratory Approval Program or a rule that any lab testing hemp be ISO 17025 certified.

  • The USDA is also considering a fee-for-service hemp laboratory approval process for labs that wish to test for THC concentration. The lab would then be approved by the USDA, AMS, Laboratory Approval Program. The USDA would then have oversight on these labs. 

  • Lab testing must use an analytic method that accounts for a total delta-9 THC concentration that is post-decarboxylation or accounts for the conversion of THCa into delta-9 THC. Currently, this includes HPLC or GC, but other analytical methods and protocols may be considered if they meet the same criteria. Any method used must meet the AOAC international standard method performance criteria.

  • A lab must report THC concentration testing to the producer and the USDA and State or Tribal authority (if a State or Tribe has an approved plan under the USDA). 

  • A lab must include a measure of uncertainty and moisture content in the results sent. 

  • If a concentration of 0.3% falls within the measurement uncertainty range, it is considered hemp. If the concentration of 0.3% falls outside of the measurement uncertainty range and is found to be higher than 0.3%, it is then considered marihuana and is a DEA Schedule I Controlled Substance.  

  • Samples collected of hemp flower for THC concentration testing must be done by a Federal, State, or Tribal law enforcement agency (or authorized representative). This process is outlined in the sampling guidelines linked above. Sampling must be done within 15 days prior to harvest. There is also a grace period of 15 days after a harvest to allow for certain circumstances.

  • Sampling procedures must ensure the cannabis grown does not exceed the acceptable THC levels. Samples should be representative of the entire hemp production. A breakdown of sampling is found in the sampling guidelines linked above.

  • The producer is responsible for the fees and costs associated with THC concentration testing. If secondary testing is required, they are also responsible for the cost associated.  

  • Tests results may be disputed or appealed. A second test may also be done, at the cost of the producer. 

  • Licensed producers notified of hemp exceeding the accepted levels must arrange for the disposal of the LOT represented by that sample in accordance with CSA and DEA regulations. The producer must document this disposal and report it to the USDA and ruling authority.  

SEEDS

  • There will be no USDA seed certification program. States and Tribes can have their own, should they choose. 

  • Hemp seeds MAY be imported from Canada with a Canadian phytosanitary certificate OR a Federal seed analysis certificate, ensuring the origin of the seeds and that no pests are present. Seeds may be imported from countries other than Canada, if accompanied by a phytosanitary certificate from that country’s ruling authority ensuring the origin of the seeds and that no pests are present. 

  • The US Animal and Plant Health Inspection Service (APHIS) will have authority over any pest issues if they arise in the importation of hemp plant material (including seeds). 

 

 

 

 

 

Analysis and Commentary

 

HEMP REGULATION PLANS

  • The determination that no state may outlaw the transportation of hemp will ultimately help producers gain access to materials and free up the industry to allow for much more interstate and international commerce. It may also open up the ability for compensation in the courts if material is unlawfully seized.

  • By not creating a certified seed program, the USDA is placing undue burden on the producers as far as liability for the crop is concerned. 

  • States already strapped for funding and resources to administer a plan will be tempted to drop their current plans and allow the USDA to take up the burden.
     

LICENSING

  • The requirement for a 10-year ban of any individual convicted of a felony related to controlled substances from acting as a producer or key officer of a company producing hemp needs more nuance. There’s a distinct difference between El Chapo and a college student convicted of possession. This regulation creates an unnecessary barrier of entry into this legal industry that will further negatively impact people who have already served time for any crime they may have committed. Furthermore, there is much documented evidence that shows minorities are disproportionately convicted for such crimes. A s such, this may impact the “civil rights” analysis the USDA conducted in forming these rules. We would recommend further definition to only include felony charges that are related to intent to distribute or involve large quantities of controlled substances, or alternately, remove felony convictions for cannabis related crimes and only include convictions for narcotics or other drugs, as an interim rule. Furthermore, such a lengthy amount of time is also directly counter to the direction towards which much state legislation is moving. This is more burdensome than most states with medical and recreational marijuana programs. Michigan, for example, only requires a background check of 7 years to get a marijuana permit.

  • The application period does NOT coincide with the post-harvest, planning phase of the following year. It coincides with the actual time of harvest. This is an extremely stressful and busy time for producers. Changing the application period to October 1st through December 31st would be much more appropriate.  

  • These rules allow for grace periods for a producer to adapt to changes in local, State, Tribal or Federal regulations and plans. This may be beneficial to producers so that they are not arbitrarily put in a position of being in violation of new rules without time to adjust.  
     

REGULATORY COMPLIANCE

  • THC Concentrations for the definition of hemp or marijuana cannot be changed by the USDA. This definition is in the 2018 Farm Bill itself, referencing the Agricultural Marketing act of 1946. Any changes to this definition would require separate legislation or an amendment to this law. Many growers, producers, processors and other entities feel this definition is outdated, arbitrary, and unjustly burdens hemp producers who act in good faith. If Federal marijuana legalization is enacted, this will become a moot point, however, in the mean time, pushing for a more relaxed legislation to pushing that concentration to 1% (such as is proposed by the EU currently) would ease the strain on producers while still maintaining a safety measure for ensuring no psychoactive effects of THC are found in hemp products.  

  • In line with the statement above, the arbitrary delineation of 0.5% THC concentration as the measure by which a violation of this act is found to be either negligible or not, is, in kind, not acceptable. Pushing that percentage to 1% would be a much more appropriate measure of whether there was or was not negligence.  

  • There is little to no clarity on what disposal methods are required/allowed, even on the DEA/CSA law as it is written. 

  • Requiring the producer to bear the disposal costs places undue burden to a producer who, either by negligence (as defined in these rules) or by good faith, produces hemp that tests above 0.3% THC.  

  • The rule stating that negligent violation cannot be prosecuted is helpful in alleviating some of the legal challenges facing the hemp industry. Although, as stated above, the markers for said negligent and good-faith growing is arbitrary and incongruent with the current status of hemp crops. To help ensure this is properly handled, clear communication and education from the USDA to ALL law enforcement agencies is needed so that farmers and producers aren't unnecessarily targeted by those agencies. 

  • These rules outline a way for negligent violations to be corrected prior to the suspension or revocation of a license. This can have a benefit by allowing producers to take corrective action instead of losing the potential to participate in the industry.  

  • The mandatory disposal of hemp as defined by these rules does not account for any of the environmental implications of said disposal. As hemp is a soil remediator, it is very powerful in removing heavy metals and contaminants from soil and keeping them. The current disposal methods often involve burning a crop, thereby not only pushing carbon into the atmosphere, but also releasing those previously mentioned compounds into the atmosphere. We recommend further study and experimentation into alternative disposal methods, avenues of remediation of THC concentration, as well as review and amendment to current definitions of cannabis.  
     

TESTING and SAMPLING

  • There is a significant lack of clarity on the part of the USDA with regards to the testing sector of the industry. The regulations as published currently do not specify if the proposed considerations for lab restrictions and regulations apply only to labs testing for official THC concentration compliance reporting, or to all 3rd party testing labs that test hemp for anything else such as THC concentration strictly for the purpose of monitoring crops through the growth cycle, testing for contaminants, terpenes, seed germination, nutrient uptake, etc. These rules need specificity and clarity on this point immediately and without delay. If these rules are to apply to all 3rd party labs, then there needs to be a timeline established for those labs to conform to these rules that is both reasonable and clearly defined. For example, the ISO 17025 certification and accreditation can take a year or more. 

  • There is, potentially, an additional burden placed upon labs who are testing for THC concentration. These burdens include a fee-for-service approval by the USDA, the requirement to be registered by the DEA, the requirement to be ISO 17025 certified, and the requirement to record and report THC concentration testing results to the USDA. While most of these restrictions will ultimately prove to be beneficial for the industry in establishing widespread standards for this testing and increase the quality of lab results, they will also place a financial burden and legal risk on a new lab. Mandatory reporting, for example, may prove to have a negative effect on an industry, as producers may be reluctant to work on and develop new strains when an entire field will be destroyed with a test result of greater than 0.5% THC  even when only one of the "development plants tested high.  

  • Hemp is known to produce variances from plant to plant. The report alludes to that fact in citing a reason for not having a certified seed program through the USDA. Such thinking must be also applied to the testing process and consequences thereof. If one plant in a field is testing at 0.6% THC and the one next to it is testing at 0.2%, the current regulations dictate that ALL plants in that lot must be disposed of. This practice and regulation is incredibly wasteful, costly, and ultimately detrimental to the industry as a whole. It will force many producers into unnecessary losses.  

  • Given the above statement, the current guidelines for sampling are lacking for accurately and appropriately determining the THC concentration of a crop. 1 plant sample will is not be an appropriate measure of what an entire acre of plants will produce. We recommend at least 5 small samples be collected for every acre, then homogenized and tested as a representative sample, OR, that 5 small samples are collected per acre, tested individually and that the results be averaged together to create a truly representative sample of what a crop or lot is producing. This should be the bare minimum, considering the variety of compounds and concentrations 2 identical plants from the same strain can produce while growing right next to each other. This would be akin to evaluating an entire school based on one child’s test scores.  This guideline should be amended to something closer to 25 samples for every 5 acres to give a much more certain result. This would give a 90% certainty +/- 20%. This doesn't even begin to address the variation in a single plant that will add to the uncertainty.

  • In line with these statements above, the tolerance range defined for "dried weight" of 5-12% provides too much of a variance of moisture content for a sample. This variance can make a huge difference in the outcome of a THC concentration analysis. If a sample is testing at 0.3% at a 12% moisture content, it will surely test higher than 0.3% (including margin of error and distribution range) if the moisture content is 5%. This will create a large amount of inter-lab variability in how samples are prepared and in any single lab, create a large “measurement of uncertainty” for every sample. The recommendation is that a benchmark formula for counting this variance be created through testing, experimentation, and data analysis. If we can determine that THCA will decarboxylate to Delta-9 THC at a rate of 87.7%, than surely, we can come up with a statistically and measured formula to account for moisture variances and the effect they will have on the THC concentration measurements through HPLC, GC, or other testing methods. Alternately, a separate margin of error should be expanded to include the variances in moisture content or labs can simply dry to 0% moisture before testing, as is the case in some states already. The allowed variances outlined currently in the testing guidelines are completely unacceptable if the strict adherence to the 0.3% THC threshold is enforced and calculated using any margin of error. To not include a margin of error for the moisture content is, again, placing an unfair burden on the producers and lacking in proper guidance for labs that are, in essence, creating a legal standpoint for a plant to be considered hemp or marijuana. 
     

SEEDS

  • By not having a seed certification system, the USDA is placing the majority of the burden and responsibility of compliance on the farmer without any policing of seed stocks by the USDA.
     

OTHER VITAL ANALYSIS AND COMMENTARY

  • There are currently no rules or provisions for the consumer safety of hemp that is produced for consumption. Other crops are tested for consumer safety, why not hemp? As previously stated, the cannabis plant will take in many contaminants from the soil and environment. As such, the plant and its products may have elevated levels heavy metals, biological toxins, pesticides and other chemicals that may be harmful to humans and animals. We recommend mandatory testing of any hemp and associated products intended for human consumption for safety. It may be prudent for the USDA to work with the FDA and CDC to formulate these provisions. 

  • There are no guidelines or provisions for remediation of excess THC above 0.3% even though such technology and methodology exists. Without providing said pathway, there is an overwhelming amount of hemp produced that will be destroyed and lost. We strongly recommend adding provisions for remediation of THC concentrations prior to any determination of a violation or determination that hemp be disposed.  

  • With the USDA publishing the new regulations, this should open the door to federal crop insurance becoming available to hemp farmers.

  • While not published in these rules or in the supporting documents, the Plant Variety Protection act does apply to hemp. As such, a varietal or strain may be subject to intellectual property protections.  

  • There is no provision for providing clarity on how hemp grown by the previous regulations should be handled now. This is essential, as much of that hemp is now going to market or in line to be processed further.  For example, a producer has a "fit for sale" certificate from the State for their crop. Is that crop now subject to these new rules as published after said certificate was issued? There needs to be a mention of a timeframe by which producers have to conform to these rules. 

 

 

 

 

 

 

Definitions

 

We have condensed the definitions as published by the USDA to only include the most relevant definitions to this overview and analysis. We feel that this section, while expurgated, is representative of the most important definitions outlined in the rules and our analysis.  
 

  • The term ‘‘applicant’’ means any State or Indian Tribe that has applied for USDA approval of a State or tribal hemp production plan for the State or Indian Tribe they represent. This term also applies to any person or business in a State or territory of an Indian Tribe not subject to a State or tribal plan, who applies for a hemp production license under the USDA plan established under this part.  

  • The term ‘‘cannabis’’ is the Latin name of the plant that, depending on its THC concentration level, is further defined as either ‘‘hemp’’ or ‘‘marijuana.’’ Cannabis is a genus of flowering plants in the family Cannabaceae of which Cannabis sativa is a species, and Cannabis indica and Cannabis ruderalis are subspecies thereof. For the purposes of this part, Cannabis refers to any form of the plant where the delta-9 tetrahydrocannabinol concentration on a dry weight basis has not yet been determined. This term is important in describing regulations that apply to plant production, sampling or handling prior to determining its THC content.  

  • The Controlled Substances Act (CSA) is the statute, codified in 21 U.S.C. 801– 971, establishing Federal U.S. drug policy under which the manufacture, importation, exportation, possession, use, and distribution of certain substances is regulated. Because cannabis containing THC concentration levels of higher than 0.3 percent is deemed to be marijuana, a schedule I controlled substance, its regulation falls under the authorities of the CSA. Therefore, for compliance purposes, the requirements of the CSA are relied upon for the disposal of cannabis that contains THC concentrations above the stated limit of this part.  

  • The rule includes a definition of ‘‘conviction’’ to explain what is considered a conviction and what is not. Specifically, a plea of guilty or nolo contendere or any finding of guilt is a conviction. However, if the finding of guilt is subsequently overturned on appeal, pardoned, or expunged, then it is not considered a conviction for purposes of part 990. This definition of ‘‘conviction’’ is consistent with how some other agencies who conduct criminal history record searches determine disqualifying crimes.  

  • A ‘‘corrective action plan’’ is a plan set forth by a State, tribal government, or USDA for a licensed hemp producer to correct a negligent violation of or non-compliance with a hemp production plan, its terms, or any other regulation set forth under this part. This term is defined in accordance with the 2018 Farm Bill, which mandates certain non-compliance actions to be addressed through corrective action plans.  

  • ‘‘Culpable mental state greater than negligence’’ is a term used in the 2018 Farm Bill to determine when certain actions would be subject to specific compliance actions. This term means to act intentionally, knowingly, willfully, recklessly, or with criminal negligence.  

  • The term ‘‘decarboxylated’’ refers to the completion of the chemical reaction that converts THC-acid (THCA) into delta-9–THC, the intoxicating component of cannabis. The decarboxylated value is also calculated using a conversion formula that sums delta-9-THC and eighty-seven and seven tenths (87.7) percent of THCA. This term, commonly used in scientific references to laboratory procedures, is the precursor to the term ‘‘post- decarboxylation,’’ a term used in the 2018 Farm Bill’s mandate over cannabis testing methodologies to identify THC concentration levels. This definition is based on the regulations administered by the Kentucky Department of Agriculture as part of the Kentucky industrial hemp research pilot program.  

  • ‘‘Delta-9 tetrahydrocannabinol,’’ also referred to as ‘‘Delta-9 THC’’ or ‘‘THC’’ is the primary psychoactive component of cannabis, and its regulation forms the basis for the regulatory action of this part. As mandated by the Act, legal hemp production must be verified as having THC concentration levels of 0.3 percent on a dry weight basis or below. For the purposes of this part, delta-9 THC and THC are interchangeable.  

  • ‘‘Dry weight basis’’ refers to a method of determining the percentage of a chemical in a substance after removing the moisture from the substance. Percentage of THC on a dry weight basis means the percentage of THC, by weight, in a cannabis item (plant, extract, or other derivative), after excluding moisture from the item.  

  • The Farm Service Agency (FSA) is an agency of the U.S. Department of Agriculture, that provides services to farm operations including loans, commodity price supports, conservation payments, and disaster assistance. For the purposes of this program, FSA will assist in information collection on land being used for hemp production.  

  • ‘‘Gas chromatography’’ or GC, is a scientific method (specifically, a type of chromatography technique) used in analytical chemistry to separate, detect, and quantify each component in a mixture. It relies on the use of heat for separating and analyzing compounds that can be vaporized without decomposition. Under the terms of this part, GC is one of the valid methods by which laboratories may test for THC concentration levels.  

  • For the purposes of this part, ‘‘geospatial location’’ means a location designated through a global system of navigational satellites used to determine the precise ground position of a place or object.  

  • This term ‘‘handle’’ is commonly understood by AMS and used across many of its administered programs. For the purposes of this part, ‘‘handle’’ refers to the actions of cultivating or storing hemp plants or hemp plant parts prior to the delivery of such plant or plant part for further processing. In cases where cannabis plants exceed the acceptable hemp THC level, handle may also refer to the disposal of those plants.  

  • ‘‘Hemp’’ is defined by the 2018 Farm Bill as ‘‘the plant species Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.’’ The statutory definition is self-explanatory, and USDA is adopting the same definition without change for part 990.  

  • ‘‘High-performance liquid chromatography (HPLC) or (LC)’’ is a scientific method (specifically, a type of chromatography) used in analytical chemistry used to separate, identify, and quantify each component in a mixture. It relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material to separate and analyze compounds. Under the terms of this part, HPLC is one of the valid methods by which laboratories may test for THC concentration levels. Ultra- Performance Liquid Chromatography (UPLC) is an additional method that may also be used as well as other liquid or gas chromatography with detection.  

  • A ‘‘key participant’’ is a person or persons who have a direct or indirect financial interest in the entity producing hemp, such as an owner or partner in a partnership. A key participant also includes persons in a corporate entity at executive levels including chief executive officer, chief operating officer and chief financial officer. This does not include such management as farm, field or shift managers.  

  • ‘‘Law enforcement agency’’ refers to all Federal, State, or local law enforcement agencies. Under the 2018 Farm Bill, State submissions of proposed hemp production plans to USDA must be made in consultation with their respective Governors and chief law enforcement officers. Moreover, the 2018 Farm Bill contemplates the involvement of law enforcement in compliance actions related to offenses identified as being made under a ‘‘culpable mental state.’’ To assist law enforcement in the fulfillment of these duties, the 2018 Farm Bill also mandates an information sharing system that provides law enforcement with real-time data.  

  • The term ‘‘lot’’ refers to a contiguous area in a field, greenhouse, or indoor growing structure containing the same variety or strain of cannabis throughout. In addition, ‘‘lot’’ is a common term in agriculture that refers to the batch or contiguous, homogeneous whole of a product being sold to a single buyer at a single time. Under the terms of this part, ‘‘lot’’ is to be defined by the producer in terms of farm location, field acreage, and variety (i.e., cultivar) and to be reported as such to the FSA.  

  • As defined in the CSA, ‘‘marihuana’’ (or ‘‘marijuana’’) means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. The term ‘marihuana’ does not include hemp, as defined in section 297A of the Agricultural Marketing Act of 1946, and does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination (7 U.S.C. 1639o(1)). ‘‘Marihuana’’ also means all cannabis that tests as having a concentration level of THC on a dry weight basis of higher than 0.3 percent.  

  • ‘‘Negligence’’ is a term used in the 2018 Farm Bill to describe when certain actions are subject to specific compliance actions. For the purposes of this part, the term means failure to exercise the level of care that a reasonably prudent person would exercise in complying with the regulations set forth under this part.  

  • Under the terms of this program, ‘‘plan’’ refers to a set of criteria or regulations under which a State or tribal government, or USDA, monitors and regulates the production of hemp. ‘‘Plan’’ may refer to a State or Tribal plan, whether approved by USDA or not, or the USDA hemp production plan.  

  • In the context of this part, ‘‘postdecarboxylation’’ means testing methodologies for THC concentration levels in hemp, where the total potential delta-9-tetrahydrocannabinol content, derived from the sum of the THC and THCA content, is determined and reported on a dry weight basis. The postdecarboxylation value of THC can be calculated by using a chromatograph technique using heat, known as gas chromatography, through which THCA is converted from its acid form to its neutral form, THC. The result of this test calculates total potential THC. The postdecarboxylation value of THC can also be calculated by using a high- performance liquid chromatograph technique, which keeps the THCA intact, and requires a conversion calculation of that THCA to calculate total potential THC. See also the definition for decarboxylation.  

  • The term ‘‘produce,’’ when used as a verb, is a common agricultural term that is often used synonymously with ‘‘grow’’ and means to propagate plants for market, or for cultivation for market, in the United States. In the context of this part, ‘‘produce’’ refers to the propagation of cannabis to produce hemp.  

  • Section 297A of the Act defines ‘‘State’’ to mean any of one of the fifty States of the United States of America, the District of Columbia, the Commonwealth of Puerto Rico, and any other territory or possession of the United States. The statutory definition is self-explanatory, and USDA is adopting the same definition without change for part 990. 

  • The term ‘‘store’’ is part of the term ‘‘handle’’ under this part and means to deposit hemp plants or hemp plant product in a storehouse, warehouse or other identified location by a producer for safekeeping prior to delivery to a recipient for further processing.  

  • As defined by the 2018 Farm Bill, the term ‘‘tribal government’’ means the governing body of an Indian Tribe. The statutory definition is self-explanatory, and USDA is adopting the same definition without change for part 990.  

  • The ‘‘U.S. Attorney General’’ is the Attorney General of the United States.  

  • In the context of this part, ‘‘licensee’’ or ‘‘USDA licensed hemp producer’’ means a person or business authorized by USDA to grow hemp under the terms established in this part and who produces hemp. 

 

Disclaimer

 

This document was created and published by Premium CBD Labs for educational purposes only. This document should not be considered legal advice or as a form of any type of amendment or addendum to the rules as outlined by the USDA. The analysis contained in this document are the opinion held by Premium CBD Labs and is not a legal standpoint or challenge to the rules as published by the USDA. Some of the analysis and points made in this document may be submitted as comment to the USDA Hemp Program Interim Rules at the discretion of Premium CBD Labs and its officers. Premium CBD Labs has prepared and published this document in good faith towards the hemp/cannabis industry and cannot be held liable for any action taken by any individual or company outside of Premium CBD Labs as any other entity is entitled to their own interpretation of the information presented here. While the written contents and analysis of this document are the intellectual property Premium CBD Labs, it is published openly and with permission to share freely only in its entirety (including this paragraph).  


We, at Premium CBD Labs, are committed to promoting the ideas of proper regulation and safety for all hemp and CBD products. As part of that commitment, we endeavor to increase the transparency of this industry by offering expertise and analysis of rules and regulations as they are proposed and adopted, especially if those rules are open to being amended through a process of comment and petition. We feel that this industry is best served by having clearly defined, fair, and accurate sampling and testing methodologies. As a scientific business, we maintain that safety regulations are a must when dealing with any product that is meant for human consumption. We also feel that regulations should not unfairly place a producer in a position of unknowingly committing criminal acts. Simply put, we feel these rules, as they stand, are beneficial in some ways and are rather detrimental in others. While they are open to a comment period and are meant to be amended, we offer this document to help educate and offer perspective on these rules. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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