Establishment of a Domestic Hemp Production Program; Comment Period Reopened, 55363-55366 [2020-17659]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Rules and Regulations]
[Pages 55363-55366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17659]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 990

[Doc. No. AMS-SC-19-0042; SC19-990-2 IR]


Establishment of a Domestic Hemp Production Program; Comment 
Period Reopened

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Interim final rule; reopening of comment period.

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SUMMARY: The Agricultural Marketing Service (AMS) is providing an 
additional thirty (30) days for public comments on the interim final 
rule (IFR) that established the Domestic Hemp Production Program on 
October 31, 2019. Reopening the comment period gives interested persons 
an additional opportunity to comment on the IFR. Comments are solicited 
from all stakeholders, notably those who were subject to the regulatory 
requirements of the IFR during the 2020 production cycle.

DATES: The comment period for the interim final rule published on 
October 31, 2019, at 84 FR 58522, is reopened. Comments must be 
received by October 8, 2020.

ADDRESSES: Interested persons are invited to submit written comments 
concerning this Notice. 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 mailed to USDA/AMS/Specialty Crops 
Program Hemp Branch, 470 L'Enfant Plaza SW, P.O. Box 23192, Washington, 
DC 20026. Comments may also be sent via electronic mail to 
[email protected]. 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.

FOR FURTHER INFORMATION CONTACT: Bill Richmond, Branch Chief, U.S. 
Domestic Hemp Production Program, Specialty Crops Program, AMS, USDA; 
1400 Independence Avenue SW, Stop 0237, Washington, DC 20250-0237; 
Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email: 
[email protected] or Patty Bennett, Director, Marketing Order 
and Agreement Division, Specialty Crops Program, AMS, USDA at the same 
address and phone number above or Email: [email protected].
    Small businesses may request additional information on this Notice 
by contacting Richard Lower, Marketing Order and Agreement Division, 
Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 
0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 
720-8938, or Email: [email protected].

SUPPLEMENTARY INFORMATION: The IFR (84 FR 58522, October 31, 2019) was 
issued under Section 10113 of Public Law 115-334 December 20, 2018, the 
Agriculture Improvement Act of 2018 (2018 Farm Bill). Section 10113 
amended the Agricultural Marketing Act

[[Page 55364]]

of 1946 (AMA) by adding Subtitle G (sections 297A through 297D of the 
AMA). Section 297B of the AMA requires the Secretary of Agriculture 
(Secretary) to evaluate and approve or disapprove State or Tribal plans 
regulating the production of hemp. Section 297C of the AMA requires the 
Secretary to establish a Federal plan for producers in States and 
territories of Indian Tribes not covered by plans approved under 
section 297B. Lastly, section 297D of the AMA requires the Secretary to 
promulgate regulations and guidelines relating to the production of 
hemp in consultation with the U.S. Attorney General. USDA is committed 
to issuing the final rule expeditiously after reviewing public comments 
and obtaining additional information during the initial implementation.

Background

    The IFR established a domestic hemp production program pursuant to 
the Agriculture Improvement Act of 2018. The IFR outlines provisions 
for the U.S. Department of Agriculture (USDA) to approve plans 
submitted by States and Indian Tribes for the domestic production of 
hemp. It also establishes a Federal plan for producers in States or 
territories of Indian Tribes that do not have their own USDA-approved 
plan. The program includes provisions for maintaining information on 
the land where hemp is produced, testing the levels of total 
tetrahydrocannabinol, disposing of plants not meeting necessary 
requirements, licensing requirements, and ensuring compliance with the 
requirements of the new part. As a supplement to statutory and 
regulatory requirements, USDA made available additional guidance 
documents on sampling and laboratory testing. In addition, on February 
27, 2020, USDA delayed requirements for hemp testing laboratories to 
obtain Drug Enforcement Administration (DEA) registration and clarified 
allowable cannabis disposal methods.
    This document notifies the public of the reopening of the comment 
period from September 8, 2020 to October 8, 2020. Comments previously 
submitted to USDA by stakeholders during the initial sixty day public 
comment period [October 31, 2019-December 30, 2019] or during the 
thirty day extension period [December 31, 2019-January 29, 2020] need 
not be resubmitted, as these comments are already incorporated into the 
public record and will be considered in the final rule.

Public Comment Requested

    AMS received approximately 4,600 comments from stakeholders during 
the initial ninety-day public comment period. These comments represent 
the perspectives of various organizations and individuals within the 
stakeholder community and provided AMS additional context for decision 
making. AMS is reopening the public comment period for the IFR to 
encourage additional input on several topics identified by commenters 
during the initial ninety-day comment period. The reopening of the 
public comment period allows stakeholders to provide AMS with further 
insight gained from the 2020 hemp growing season. AMS is interested in 
this additional input for all aspects of the U.S. domestic hemp 
production program, and particularly interested in comments on the 
following topics:

1: Measurement of Uncertainty for Sampling

    The IFR addresses the measurement of uncertainty (MU) in laboratory 
activities by requiring labs to report the MU as part of any hemp test 
results. However, the IFR does not address or provide an MU to account 
for the variability that may occur prior to a sample arriving at a 
laboratory during cutting, bagging, sealing, transporting, handling, 
and other ``pre-laboratory'' activities. Multiple commenters suggested 
the establishment of an additional MU to account for this variability 
in addition to the MU provided in the IFR applicable to ``in-
laboratory'' activities. Commenters said that sampling uncertainty 
arises from the processes related to the collection and handling of the 
actual plant material to be tested, and the omission of sampling 
uncertainty in the MU will certainly result in inaccurate, incomplete, 
and otherwise invalid test results due to the nature of the hemp 
sampling. One potential way to address this, as presented in a comment, 
would add an additional MU for pre-laboratory activities (a), in 
addition to the measurement of uncertainty for in-laboratory activities 
(b), such that a total measurement of uncertainty (c) can be calculated 
as the square root of the sum of those squared values (a squared plus b 
squared = c squared). For example, if the in-laboratory measurement of 
uncertainty (b) is calculated as 0.0300 percent, and the pre-laboratory 
measurement of uncertainty (a) is estimated to be 0.0400 percent, then 
the total measurement of uncertainty (c) would be 0.0500 percent. AMS 
seeks additional information on this topic and alternative proposals on 
how to compute the MU for sampling. Numerical valuations or calculation 
formulas submitted with comments should clearly demonstrate how 
sampling uncertainty might be incorporated into the current THC 
tolerance threshold established by the IFR.

2: Liquid Chromatography Factor, 0.877

    The 2018 Farm Bill mandates that all cannabis be tested for THC 
concentration levels using ``postdecarboxylation'' or similar methods. 
As explained in the IFR, ``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 (``LC or ``HPLC''), 
which keeps the THCA intact, and requires a conversion calculation of 
THCA to calculate total potential THC. As explained in the IFR, the 
decarboxylated value is calculated using a conversion formula that sums 
delta-9-THC ([Delta]\9\-THC) and (87.7) percent of THC-A. Several 
commenters claim that this formula is inaccurate since it is based on a 
100 percent conversion factor, which is nearly impossible to achieve in 
a laboratory setting. In other words, commenters claim that since the 
conversion of the THCA to [Delta]\9\-THC is never perfectly complete 
without loss or degradation of starting material, the molar sum of 
[Delta]\9\-THC and THCA-A measured by LC is always higher than the 
total [Delta]\9\-THC measured by GC. To account for this, commenters 
presented several alternative computation methods, one of which would 
not multiply the THCA content by 87.7 percent, but rather by 52.62 
percent, which is 60 percent of 87.7 percent. Based on comments 
questioning the accuracy of this figure, AMS seeks additional 
information from stakeholders regarding the use of this conversion 
formula. Any alternative factors provided should be clearly quantified 
and explained.

3: Disposal and Remediation of Non-Compliant Plants

    The IFR requires non-compliant cannabis plants be disposed of 
through a DEA-registered reverse-distributor or other law enforcement 
personnel. Under

[[Page 55365]]

the IFR, no part of a non-compliant plant may be retained or 
``remediated'' for non-ingestible uses like fiber, seed, or pulp. Many 
comments on the IFR expressed concern about these disposal 
requirements. Because of this, in February 2020, AMS issued guidance 
relaxing the requirements for law enforcement-supervised disposal of 
non-compliant plants and provided examples of how disposal of non-
compliant plants may occur on a farm.\1\ AMS is now requesting 
additional comment on these disposal practices, including the potential 
for ``remediation'' of non-compliant plants. Commenters presented 
several ideas on how remediation might occur including separation of 
floral material, rendering plant material as ``non-consumable'', or 
``non-ingestible'', removing THC from non-compliant plants using 
methods like filtering or other further processing, or allowing States 
and Tribes the option to establish their own allowable remediation 
practices. AMS is also requesting input on whether the on-farm disposal 
methods provided in the guidance issued on February 27, 2020, (plowing 
under, mulching, disking, mowing, burying, or burning) is adequate. AMS 
encourages the submission of quantitative and qualitative data to 
identify and demonstrate alternative disposal and remediation 
activities that ensure non-compliant plant material does not enter the 
stream of commerce.
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    \1\ https://www.ams.usda.gov/rules-regulations/hemp/enforcement
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4: Negligence

    The 2018 Farm Bill establishes criteria to define certain negligent 
acts, including failing to provide a legal description of land where 
hemp is produced, not obtaining a license to produce hemp, or growing 
non-compliant plants. With regard to the production of non-compliant 
cannabis plants, the IFR states that ``hemp producers do not commit a 
negligent violation if they produce plants that exceed the acceptable 
hemp THC level and use reasonable efforts to grow hemp and the plant 
does not have a THC concentration of more than 0.5 percent on a dry 
weight basis.'' Commenters to the IFR suggested AMS increase the 
negligence threshold from 0.5 percent to 1.0 percent. AMS seeks 
additional stakeholder comments specific to this suggestion. Comments 
should include quantitative and qualitative data if available.

5: Interstate Commerce

    The 2018 Farm Bill and IFR indicate that no State or Indian Tribe 
may prohibit the transportation or shipment of legally produced hemp 
across State or Tribal boundaries. Based on comments to the IFR, we are 
seeking additional input on whether the IFR is sufficient, or if 
additional regulatory requirements are needed, to facilitate domestic 
interstate commerce and transactions, particularly the potential need 
for national, comprehensive, documentation requirements. Commenters 
presented several proposals on the kinds of documentation that should 
be required to accompany raw hemp during transport from a farm to a 
processing and/or a drying facility. For example, commenters suggested 
that producers be required to include certain documentation such as 
copies of the laboratory testing report(s), hemp grower license, 
invoice/bill of lading, and contact information of buyer and seller. 
AMS is requesting comments on whether documentation of this nature 
should be required to accompany all shipments of hemp throughout the 
U.S.

6: 15-Day Harvest Window

    The IFR requires that within 15 days prior to the anticipated 
harvest of cannabis plants, a producer shall have an approved Federal, 
State, or local law enforcement agency or other USDA-designated person 
collect samples from plants for the purpose of determining THC 
concentration. This requirement was established to ensure accuracy in 
THC testing, since THC concentration in cannabis increases the longer 
the plant is left in the ground. AMS received a significant number of 
comments on the 15-day requirement during the initial comment period. 
Commenters to the IFR suggested AMS increase the 15-day window to 30 
days. AMS is seeking additional comments on this suggestion as well as 
explanations on why a 30-day window may be more appropriate. Any 
quantitative and qualitative data provided by stakeholders should be 
specific and clarify alternative recommended time frames.

7: Hemp Seedlings, Microgreens, and Clones

    The 2018 Farm Bill and IFR established statutory and regulatory 
criteria for commercial hemp production, including sampling and testing 
of cannabis flower material from mature cannabis plants regardless of 
the intended final use of the plant. Based on comments submitted in 
response to the IFR, AMS now seeks additional information from 
stakeholders regarding agricultural operations that grow cannabis 
plants, but not to maturity, and without mature flowers. These 
facilities include seedling, seed, clone, microgreen, and other types 
of operations that do not grow hemp plants for harvesting mature hemp 
flowers, and are therefore unable to meet the sampling and testing 
requirements as described in the IFR. AMS is considering the inclusion 
of specific regulatory provisions to still require licensing but not 
subject licensees to the same sampling and testing criteria as required 
of traditional hemp growers that sell mature hemp into the stream of 
commerce. AMS is also requesting additional input on research 
associated with the THC concentration of immature hemp plants, and any 
other additional justification on why these types of facilities should 
not be subject to sampling and testing requirements.

8: Hemp Breeding and Research

    The 2018 Farm Bill and IFR identify the legal requirement to 
dispose of non-compliant cannabis plants produced at commercial hemp 
farming facilities. The IFR does not speak to the requirements for hemp 
breeding and research facilities, many of which are operated by States 
and land-grant research institutions. These types of facilities are 
engaged in a wide range of research efforts to develop new hemp 
cultivars. USDA encourages this type of research and wants to establish 
a regulatory framework for researchers that is flexible and not 
burdensome. Based on comments submitted to the IFR on the need for 
regulatory clarity for these types of facilities, AMS requests input on 
how the final rule might regulate breeding and/or research facilities. 
AMS is considering establishing certain regulatory provisions for 
researchers and research facilities. Specifically, AMS is requesting 
input on whether employees of research facilities should be required to 
obtain a license, and whether these types of facilities should have 
certain disposal protocols for non-compliant plants. AMS is also 
considering an exemption for researchers and research facilities from 
the sampling and testing requirements required of traditional hemp 
growers who sell hemp into the stream of commerce.

9: Sampling Methodology--Flower vs. Whole Plant

    Because THC is concentrated in the flower material of hemp plants, 
the IFR requires that hemp samples or ``cuttings'' be collected from 
the flowers of hemp plants. Comments received on

[[Page 55366]]

this topic suggested that samples should be collected from not only the 
flower material of the plant, but from a composite sample of the entire 
hemp plant, including flowers, stems, stalks, and potentially seeds. 
AMS is considering the inclusion of sampling provisions that allow for 
``whole-plant'' sampling, as well as a specific requirement for the 
length of a sample (ie. ``two inches'' or ``20 centimeters''), and is 
requesting input on these specific topics. AMS is also requesting input 
on specific requirements for ``milling'' or preparation of a hemp 
sample prior to laboratory analysis. One comment suggested AMS revise 
regulations conform more closely to the practices recommended by AOAC, 
particularly those methods pertaining to grinding specifications 
(2018.11 \2\) and moisture content (930.04 \3\), or consider the 
protocols developed by the Division of Regulatory Services within the 
University of Kentucky's College of Agriculture, Food and Environment, 
specifically SOP#HMP-LB-001 \4\ (Procedures for Receiving, Preparing 
and Releasing Hemp Samples), and SOP#HMP-LB-002 \5\ (Procedures for 
Measuring [Delta]-\9\ THC Content in Industrial Hemp by Gas 
Chromatography with Flame Ionization Detection).
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    \2\ AOAC Official Method of Analysis 2018.11.
    \3\ AOAC Official Method of Analysis 930.04.
    \4\ See https://www.kyagr.com/marketing/hemp-law.html.
    \5\ See: https://www.kyagr.com/marketing/hemp-law.html.
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10: Sampling Methodology--Homogenous Composition, Frequency, and Volume

    The IFR requires that sampling be conducted to ensure a 
representative sample of each lot. As part of this requirement, the 
number of samples collected must be sufficient so that, at a confidence 
level of 95 percent, no more than one percent of the plants in the lot 
would exceed the acceptable hemp THC level. The sampling requirements 
in the IFR do not take into account differences between varietals or 
different end uses of hemp plants.
    Many commenters explained that the sampling requirements imposed by 
the IFR are expensive, burdensome, and nearly impossible to meet by 
State Departments of Agriculture and Tribal governments. Based on this 
input, AMS is considering several changes to the sampling requirements; 
these changes would modify the number of samples required to be 
collected, and/or provide for the States and Tribes to establish 
sampling requirements based on end-use.
    AMS is considering establishing a specific number of plants to be 
sampled from every lot, regardless of the lot size, and is requesting 
input on how to establish these requirements. Specifically, AMS is 
requesting input on how to potentially establish a fixed sliding scale 
(for example, a lot of fewer than 10 acres requires a sample of five 
plants; a lot of between 10 and 20 acres requires six plants; etc.,) 
rather than leaving those calculations to each State and Tribe.
    AMS is also considering establishment of different sampling and 
testing requirements for hemp based on end use (i.e., risk-based.) AMS 
further seeks stakeholder comment on potential risk-based methods for 
hemp lot sampling for differing varietals intended for fiber, grain, 
seed, or biomass for extract. Methodology discussed should show 
quantitative and qualitative data and estimate potential risk levels 
(i.e., the expected likelihood of growing non-compliant hemp) for 
different varietals based on the plant's intended end use.

11: Sampling Agents

    The IFR requires that all hemp production must be sampled and 
tested for THC concentration levels, and that samples must be collected 
by a USDA-approved sampling agent or a Federal, State, or local law 
enforcement agent authorized by USDA to collect samples. Currently, 
sampling agents are required to complete a basic training module 
offered by AMS. AMS is now soliciting comment on the potential need for 
more rigorous training and/or certification requirements for sampling 
agents. For example, AMS is interested in whether sampling agents 
should be required to complete an online training module administered 
by AMS and pass an examination. Or, alternatively, whether States and 
Tribes should be able to develop and require the completion of specific 
training programs for sampling agents under their respective State or 
Tribal hemp programs. AMS is specifically requesting input on the 
content of sampling agent training, the frequency with which training 
should occur, and whether AMS should maintain a national list of 
trained sampling agents on the AMS website. The comments should clearly 
explain why additional requirements may be necessary and suggest what 
those additional requirements may entail.

12. DEA Laboratory Registration

    The IFR requires that laboratory testing of hemp for the purpose of 
determining compliance under the U.S. Domestic Hemp Product Program be 
conducted by laboratories appropriately registered with the Drug 
Enforcement Administration (DEA).
    On February 27, 2020, USDA announced guidance \6\ delaying the 
requirement to use laboratories registered with DEA for testing (7 CFR 
990.3(a)(3)(i) and 990.26(e)). Under this guidance, testing can be 
conducted by labs that are not yet DEA-registered until the final rule 
is published, or Oct. 31, 2021, whichever comes first. This change was 
intended to allow additional time to increase DEA-registered analytical 
lab capacity. AMS is now requesting additional input on whether the DEA 
laboratory registration requirement should be permanently removed, and 
if so, how lab disposal requirements of non-compliant hemp samples will 
adhere to the requirements of the Controlled Substances Act.
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    \6\ https://www.ams.usda.gov/rules-regulations/hemp/enforcement.

Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-17659 Filed 9-4-20; 8:45 am]
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