The Hemp Mine's Response to the USDA Interim Final Rule

The Hemp Mine's Response to the USDA Interim Final Rule

In the months since hemp was federally legalized under the 2018 Farm Bill, the USDA (United States Department of Agriculture) crafted a 43-page document of proposed regulations.  These regulations include aspects of hemp cultivation such as testing, harvest, destruction protocols, etc.  Some of these proposed regulations are very much in line with states currently cultivating under the 2014 Farm Bill Regulations and some are much more restrictive.  These rules will be in effect for the next two years.

The USDA is officially accepting public comments on its proposed regulations for hemp.  Though it sometimes feels our voice is small when it comes to government regulations and choices, nonetheless, we must participate.  Understanding these rules to the fullest extent, teaching each other how to maneuver in a newly regulated state, and voicing our opinions when things need changed is how we can make the most out of our industry.

We ask you to please submit comments!  Turn in your own thoughts and experiences, copy and paste these below, or only pick a few- we encourage you to submit something to show the support of us in the industry. 

Comments should be submitted via the Federal eRulemaking portal at www.regulations.gov. Comments may also be filed with Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; or Fax: (202) 720-8938. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours or can be viewed at: www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public.

DUE January 29th 2020

 

General Reading and Links

Status of State and Tribal Hemp Production Plans for USDA Approval:

This link summarizes the status of State and Tribal hemp production plans that are pending approval or have been approved.

https://www.ams.usda.gov/rules-regulations/hemp/state-and-tribal-plan-review

 

USDA Hemp Making Rule Documents:

The link below contains pdfs of Interim Final Rule, Testing/Sampling Guidelines, etc.

https://www.ams.usda.gov/rules-regulations/hemp/rulemaking-documents

 

What is “TOTAL THC” and how does it differ from Delta-9 THC?

In this link the difference between Total THC and Delta-9 THC is explained in detail.  This might seem very long and boring but if you are in this industry to any extent you need to read and understand it.  The devil is in the details- education is power.

https://cannabusiness.law/what-is-total-thc-and-does-it-matter/

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The Hemp Mine’s Comments to the USDA/FDA

To whom it may concern:

We realize the effort and thought put behind making rules to establish the domestic hemp program and we thank you.  Guidelines by Federal Lawmakers are exactly what America needs to unite American Hemp farmers, chemists, families, and businesses of all types.  Many states have been in operation for years while others are just getting started.  The states which have been in operation for multiple years have experienced first-hand some of the difficulties which are addressed in the new regulations.  While we find the rules in general as necessary, we find some to be overly restrictive.  Please see our concerns listed below:

HARVEST WINDOW

Because of the visual similarity between hemp and marijuana, we agree there should be strict protocols around testing.   Although, because this is an everchanging living organism growing in the mercy of mother nature, such strict regulations that may look feasible on paper, may not be in practice.  In the proposed regulations it states, “Within 15 days prior to the anticipated harvest of cannabis plants, a producer shall have an approved Federal, State, local law enforcement agency or other USDA designated person collect samples from the flower material of such cannabis material for delta-9 tetrahydrocannabinol concentration level testing.”  Harvest is one of the most difficult and costly portions of growing hemp.  Small farmers struggle as this is done manually and many times by only a small team.  For large farmers this may be done with the assistance of equipment, yet even more so at the mercy of a dry season for equipment field entry. 

Please consider this scenario: A farmer calls the Department of Ag to request sampling one month prior to an expected harvest date to get on the sampling schedule.  It is a very busy season for the testing agency due to all of the new hemp farmers, so the Rep is not able to visit and collect samples until 9 days before harvest, as this is within the 15 day window.  The agency collects samples on day 9 before harvest and the farmer is legally allowed to begin harvest on day 8 prior to harvest.  This season is unexpectedly rainy and a downpour starts at day 8 and lasts two full days.  After the rain stops, the farmer needs to allow the field to drain well enough (3-4 days) to get the tractor and trailers into the field.   Now the farmer has only two days to harvest his 200 acre lot of ‘Baox’.  This is an impossible feat ultimately resulting in failure for the farmer due to circumstances out of reach.   This can be avoided by the suggestions below.

  •    The farmer must alert the testing agency within a 45 day window. 
  •     The testing agency is allotted 15 days to complete testing after the submitted request, this equates to a full 30 days for harvesting.

    We need to remember that this is a living plant with many different cultivars.  Each cultivar will grow differently, and the progression of cannabinoids will be different for that cultivar over time.  Some cultivars will spike in THC early throughout flower, meaning this would be detected at a 15 day harvest, while some progress later in flower–potentially the last two weeks of flower.  For example, if a farmer tests 15 days prior to harvest and is compliant at 0.3% Total THC and then during those last two weeks the THC grows to 0.4%, there could be serious repercussion after harvest.   Problems could occur during transport or for admission into a processing facility even though a farmer had abided by all regulations set forth by the Federal Government.  We need to get ahead of these problems by implementing lenience for the biology of this plant.  Our suggestion:

    • Allow an increase of up to 0.1% THC content for post-harvest testing in batches that were compliant during pre-harvest testing.

    SAMPLING NUMBER

    There are two ways to plant hemp in the field: seed and vegetative liner (aka. Clone).  Vegetative liners are exact genetic replicates from a mother plant.  If this mother plant has been tested, one could expect the liners to be very homogeneous and test similar to the mother plant and certainly to each other. Because of the youth of this industry, there has not been time for seed to become truly stable and consistent.  Thus, for most seed lots, multiple phenotypes are observed.  These phenotypes are not only different in appearance but also chemotypical expression.  If only one plant per acre is tested, this does not give a true representation of the seed lot.  For example, if a seed crop has one phenotype at 0.2% THC representing 50% of the lot and another phenotype representing 0.4% THC of the lot, there is a 50:50 chance that the farmer will fail due to testing procedures, not due to the true representation of the crop. This can be avoided by the suggestions below.

    • Sampling should be conducted to represent a statistically true representation of the crop. For crops under 10 acres sampling is a percentage.  Perhaps, 0.2% of plants should be tested per acre.  If 3000 plants are in one acre (3000x0.002=6) this results in testing 6 plants which should be homogenized and then tested.

    SAMPLING LOCATION ON PLANT

    The proposed regulations state, “The cut shall be made just underneath a flowering material, meaning inflorescence (the flower or bud of a plant), located at the top one-third (1/3) of the plant.”  Hemp, whether grown for fiber, seed or cannabinoids, is not utilized only for the top 1/3 of the plant.  Testing should occur to represent what the processor, the next person in the production line, would receive.  For example, in cannabinoid cultivation, floral portions from the whole plant are removed and processed.  Because of the bulk of flower that is processed, leaves, small stems, and flowers from every area of the plant are blended and processed.  This blend is what should be tested and regulated.  Apical floral portions of the hemp plant are not a true representation of the plant.  These apical flowers are receiving the highest light levels which converts to higher cannabinoid production.  Testing in this region only represents the highest potential of a small amount of the plant, not the homogenized biomass that the processor would receive.  This can be avoided by the suggestions below.

    • Samples should be taken from the top, middle, and bottom of plant to yield a true representation of the plant’s THC potential.

      GENERAL HORTICULTURAL SUGGESTIONS

    Please note the plant in the sampling picture is male and does not provide a good representation to the testing agency on the type of plant to recognize.  See below:

    The word “cutting” is frequently used to describe the piece of plant that should be taken for sampling.  This word in most other realms of horticulture/agriculture indicates an explant that is used for vegetative propagation.  In this scenario it indicates something much different and could cause confusion.  The suggested word is “floral sample”.

     

    GENERAL SAMPLE PREPARATION AND TESTING PROCEDURES

     Point 3 of General Sample Preparation and Testing Procedures states the following, “Mill and “manicure” sample through a wire screen no larger than 1.5 x 1.5mm to discard mature seeds and larger twigs and stems.”  The twigs and stems are a portion of the plant which the processor will not remove prior to extraction.  These also serve as a diluting agent as they contain little to no cannabinoids. This method allows for interpretive bias by a laboratory employee potentially leading to crop failure.  This can be avoided by the suggestions below.

    • All plant material sampled should be milled, homogenized and tested.

    Variance for the measurement of THC is so strict yet the allowance for dilution is so great.  In the proposed regulations it suggests a moisture content of 5-12%. This range is much too large and can lead to inconsistent results within samples. The range allows for inconsistency in laboratory sample treatment which can lead to highly variable results. Regulations with a wide range of interpretation can lead to unfair crop failure and laboratory “shopping”. See theoretical graph below:

    Graph created by Pat Jack

    As you can see in the graph above, water acts as a dilutant.  Depending on the drying methods individual labs choose, this could lead to a pass or fail on the same sample all within permitted regulation. This can be avoided by the suggestions below.

    • Regulate all labs to test at a moisture content of 8-10%.

    The new proposed regulations suggest a measure of uncertainty granted by laboratories.  This is a fantastic idea but should be standardized.  All farmers will want to pursue methods and partners to succeed.  If one laboratory reports a higher measure of uncertainty, this lab will be priority.  With no implementation of standardized testing costs, these labs will take advantage of the farmer because of the language in regulation. This can be avoided by the suggestion  below.

    • Standardize the measure of uncertainty at +/- 0.1%.

    Total THC versus THC Delta-9

    There are few cannabis varieties which reach maturity and stay under the 0.3% THC threshold at full maturity.  The varieties which do, also contain low CBD.  In South Carolina for example, the 2018 and 2019 years were regulated under 0.3% Delta 9 rules.  In a study by Dr. Marion Snyder looking at 380 samples submitted to an ISO accredited lab, 370 passed legal limits (Figure 1).  This is a 97.3% success rate.  If we look at the same Total THC for these same samples, only 230 of 380 pass, giving a 40% rate of failure (Figure 2).  Additionally, all samples submitted would be able to pass a 1% total THC regulation.  There is an obvious trend that shows the increase of THC gives rise to an increase in CBD, specifically 0.1% increase in Total THC for every 2% increase in Total CBD across the more than 50 strains.

    Figure 1.

    Figure 2.

    There is no difference between hemp that is grown to 0.3% total THC verses 0.6% in terms of public safety.  What this small number DOES equate to is millions of dollars lost due to destroyed crops, limited genetic selection, and reduced potency potential.  For example, if a farmer spends $10K/acre on labor and genetics and is limited by genetic selection (potency) the profit difference is ginormous, see below:

    Limiting the cultivation of a hemp variety yielding 0.3% versus 0.6% (or even 1%) Total THC is absurd when we consider what happens post processing.  No matter the type of extraction (CO2, butane, ethanol, etc.), a floral product which is 0.1 or 0.8 % total THC, will always become illegal in the primary crude stage (2- 4% total THC).  This product must be diluted or have the THC removed prior to distribution to the public.  This new regulation will also increase the need for testing which is already a financial burden on the farmer.  Finally, many crops will be harvested early from fear of regulators destroying crops- this will decrease profits for the farmer even greater.

    • Suggestion: Federal regulation should continue to use Delta 9 THC OR 1% Total THC for hemp regulation.

    Reference:

    https://cannabusiness.law/total-thc-and-the-usda-rule-a-data-driven-analysis/

    In conclusion, we’d again like to thank the USDA for assisting the United States farmers, chemists, and all persons involved in the hemp industry.  We hope that together we can grow this to be a profitable and fair journey.  We greatly thank you for taking time to read our comments and would be happy to help in any fashion or answer questions.

    Gratefully,

    Dr. Allison Justice & The Hemp Mine Team