Establishment of a Domestic Hemp Production Program
| Citation | 86 FR 5596 |
| Published date | 19 January 2021 |
| Record Number | 2021-00967 |
| Section | Rules and Regulations |
| Court | Agricultural Marketing Service |
Federal Register, Volume 86 Issue 11 (Tuesday, January 19, 2021)
[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Rules and Regulations]
[Pages 5596-5691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00967]
[[Page 5595]]
Vol. 86
Tuesday,
No. 11
January 19, 2021
Part VIDepartment of Agriculture-----------------------------------------------------------------------Agricultural Marketing Service-----------------------------------------------------------------------7 CFR Part 990Establishment of a Domestic Hemp Production Program; Final Rule
Federal Register / Vol. 86 , No. 11 / Tuesday, January 19, 2021 /
Rules and Regulations
[[Page 5596]]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 990
[Doc. No. AMS-SC-19-0042; SC19-990-2 FR]
Establishment of a Domestic Hemp Production Program
AGENCY: Agricultural Marketing Service, Department of Agriculture
(USDA).
ACTION: Final rule.
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SUMMARY: This final rule supersedes the interim final rule that
established the Domestic Hemp Production Program, as mandated by the
Agriculture Improvement Act of 2018 (2018 Farm Bill). This rule
includes regulations used by the Department of Agriculture (USDA) to
approve plans submitted by States and Indian Tribes for the domestic
production of hemp. This rule also includes regulations on the Federal
hemp production plan for producers in States or territories of Indian
Tribes that do not have their own USDA-approved plans. The program
provides requirements for maintaining records about the land where hemp
is produced, testing the levels of total delta-9 tetrahydrocannabinol,
disposing of non-compliant plants, licensing hemp producers, and
ensuring compliance under the new program.
DATES: This rule is effective March 22, 2021.
FOR FURTHER INFORMATION CONTACT: Bill Richmond, Branch Chief, U.S.
Domestic Hemp Production Program, Specialty Crops Program, AMS, USDA;
1400 Independence Ave. SW, Stop 0237, Washington, DC, 20250-0237;
Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
[email protected].
SUPPLEMENTARY INFORMATION: This rule is issued under the authority of
section 10113 of the 2018 Farm Bill (Pub. L. 115-334; December 20,
2018), which amended the Agricultural Marketing Act of 1946, as
previously amended (7 U.S.C. 1621 et seq.) (AMA), by adding Subtitle G
(sections 297A through 297E). 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. Section 297D of the AMA
requires the Secretary to promulgate regulations and guidelines
relating to the production of hemp under sections 297B and 297C in
consultation with the U.S. Attorney General.
AMS issued an interim final rule (IFR) on October 31, 2019 (84 FR
58522), and began its initial implementation of the program. To date,
USDA has approved approximately 45 State and Tribal hemp plans.
However, not all of the States and Tribes have implemented their plans
for various reasons, including the need to take additional steps to
complete State legislative or rulemaking processes or to establish the
regulatory scheme as well as the extension of the 2014 Farm Bill
Program. Thus, as of November 2020, twenty States and nine Tribes have
submitted reports on their respective programs. Based on the reports
submitted by States and Tribes in 2020, producers have planted 6,166
acres under the 2018 Farm Bill hemp plans, of which approximately 730
acres were subject to disposal.
As of the effective date of this final rule, the interim final rule
is superseded. This final rule replaces the IFR at 7 CFR part 990,
effective March 22, 2021. The Agricultural Marketing Service (AMS),
which has been delegated authority to administer the U.S. Domestic Hemp
Production Program, provided multiple opportunities for public comment.
AMS accepted comments during an initial comment period from October 31,
2019, through December 31, 2019. This initial comment period was
extended for an additional 30 days on December 18, 2019 (84 FR 69295),
ending January 29, 2020. AMS reopened the comment period for 30
additional days on September 8, 2020 (85 FR 55363), ending October 8,
2020. A total of approximately 5,900 comments were received during all
comment periods from States; Indian Tribes; industry and agricultural
organizations; private citizens; members of Congress, the scientific
community; agencies; and individuals involved in the growing,
processing, transporting and marketing of hemp. A summary of the public
comments received and AMS's responses appear under ``Comment Analysis''
in section IX of this document.
I. Introduction
Hemp is a commodity with numerous industrial and horticultural uses
including fabric, paper, construction materials, food products,
cosmetics, production of cannabinoids (such as cannabidiol or CBD), and
other products.\1\ While hemp was produced previously in the United
States (U.S.) for hundreds of years, its use diminished in favor of
alternatives. Hemp fiber, for instance, which had been used to make
rope and clothing, was replaced by less expensive jute and abaca
imported from Asia. Rope made from these materials was lighter, more
buoyant, and more resistant to saltwater than hemp rope, which required
tarring. Improvements in technology further contributed to the decline
in hemp use. The cotton gin, for example, simplified the processing of
cotton, which replaced hemp in the manufacture of textiles.
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\1\ Section 297D(c) of the AMA explicitly preserved the
authority of the U.S. Food and Drug Administration (FDA) to
promulgate regulations and guidance related to the production of
hemp under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301
et seq.) (FD&C Act) and section 351 of the Public Health Service Act
(42 U.S.C. 262) (PHS Act). See section 297D(c)(1) (``Nothing in this
subchapter shall affect or modify . . . the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.); section 351 of the Public
Health Service Act (42 U.S.C. 262); or the authority of the
Commissioner of Food and Drugs and the Secretary of Health and Human
Services . . . '' under those Acts).
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The hemp industry continued in the U.S. until the Marihuana Tax Act
of 1938. This Act ended the legal production of hemp in the United
States, and hemp was added to Schedule I of the Controlled Substances
Act (CSA), 21 U.S.C. 801 et seq. Prior to the 2018 Farm Bill, all
Cannabis sativa L., regardless of delta-9 tetrahydrocannabinol (THC)
concentration level, fell within the CSA definition of ``marihuana''
unless the product fell under a narrow range of exceptions (e.g., the
``mature stalks'' of the plant).\2\ As a result, many aspects of
domestic production of what is now defined as hemp was limited to
persons registered under the CSA to do so.
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\2\ Although the statutory spelling is ``marihuana'' in the
Controlled Substances Act, this rule uses the more commonly used
spelling of marijuana.
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Under the Agricultural Act of 2014 (2014 Farm Bill), Public Law
113-79, State departments of agriculture and institutions of higher
education were permitted to produce hemp as part of a pilot program for
research purposes. The authority for hemp production provided in the
2014 Farm Bill was extended until January 1, 2022, by the Continuing
Appropriations Act, 2021, and Other Extensions Act (Pub. L. 116-260)
(2021 Continuing Appropriations Act).
Hemp production in the U.S. has seen a resurgence in the last
several years.
Since importation of seed is covered under USDA's Animal and Plant
Health Inspection Service (APHIS) regulations, this final rule does not
regulate hemp
[[Page 5597]]
seed imports. APHIS regulates the importation of all seeds for planting
to ensure safe agricultural trade. Hemp seeds can be imported into the
U.S. from Canada if accompanied by either: (1) A phytosanitary
certification from Canada's national plant protection organization to
verify the origin of the seed and confirm that no plant pests are
detected; or (2) a Federal Seed Analysis Certificate (SAC, PPQ Form
925) for hemp seeds grown in Canada. Hemp seeds imported into the U.S.
from countries other than Canada may be accompanied by a phytosanitary
certificate from the exporting country's national plant protection
organization to verify the origin of the seed and confirm that no plant
pests are detected.
This final rule does not address the exportation of hemp. Should
there be sufficient public interest in exporting hemp in the future,
USDA will work with industry and other Federal agencies to help
facilitate this process.
The 2018 Farm Bill requires USDA to promulgate regulations and
guidelines to establish and administer a program for the production of
hemp in the United States. Under this new authority, a State or Indian
Tribe that wants to have primary regulatory authority over the
production of hemp in that State or territory of that Indian Tribe may
submit, for the approval of the Secretary, a plan concerning the
monitoring and regulation of such hemp production. For States or Indian
Tribes without an approved plan, the Secretary is directed to establish
a Departmental plan to monitor and regulate hemp production in those
areas.
The 2018 Farm Bill specifies requirements that all hemp producers
must meet. These include licensing requirements; recordkeeping
requirements for maintaining information about the land where hemp is
produced; procedures for testing the THC concentration levels for hemp;
procedures for disposing of non-compliant plants; compliance
provisions; and procedures for handling violations.
For the purposes of 7 CFR part 990, and as defined in the 2018 Farm
Bill, the term ``hemp'' means 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.
Delta-9 tetrahydrocannabinol, or THC, is the primary intoxicating
component of cannabis. Cannabis with a THC level exceeding 0.3 percent
is considered marijuana, which remains classified as a Schedule I
controlled substance regulated by the Drug Enforcement Administration
(DEA) under the CSA.
The term ``State'' means 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 term ``Indian Tribe'' or ``Tribe'' has the same definition
as in section 4 of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 5304). This final rule also includes the
definition of ``territory of an Indian Tribe'' to provide clarity to
the term because the AMA does not define it. The final rule defines
``territory of the Indian Tribe'' as (a) all land within the limits of
any Indian reservation under the jurisdiction of the United States
Government, notwithstanding the issuance of any patent, including
rights-of-way running through the reservation; (b) all dependent Indian
communities within the borders of the United States whether within the
original or subsequently acquired territory thereof, and whether within
or without the limits of a state; (c) all Indian allotments, the Indian
titles to which have not been extinguished, including rights-of-way
running through the same; and (d) any lands title to which is either
held in trust by the United States for the benefit of any Indian Tribe
or individual or held by any Indian Tribe or individual subject to
restriction by the United States against alienation and over which an
Indian Tribe exercises jurisdiction. Under an approved Tribal plan, the
Indian Tribe will have regulatory authority over hemp production within
its Territory.\3\ A full list of terms and definitions relating to part
990 can be found under ``Definitions'' in section IV.
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\3\ We note that if an Alaskan Native Corporation wants to
produce hemp on land it owns in fee simple, it would need to have a
State or USDA license, whichever is applicable, because that land
does not qualify as Indian Country and the Corporation does not have
jurisdiction over that land.
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This rule is divided into several sections. The first section
provides a general introduction to the rule. This section does not go
into a detailed description of all parts of the rule or about the
provisions of the rule that are discussed later on in other sections.
Sections for State and Tribal plans as well as the USDA plan contain
general information on land use, tribal jurisdiction authority,
sampling, testing, disposal and remediation, compliance provisions,
information sharing, certification of resources, and State and Tribal
plan approvals. The USDA section also includes USDA hemp license
provisions and suspension. These two sections provide general
provisions that are discussed in more detail in the comment analysis
section. Sections containing definitions, severability and the
regulatory analysis are included before the regulatory language. The
reader may be best served by reading the comment section to determine
the changes made to this rule.
II. State and Tribal Plans
Section 297B (7 U.S.C. 1639p) of the AMA requires that States or
Indian Tribes seeking primary regulatory authority over the production
of hemp in that State or territory of that Indian Tribe, submit, for
the approval of the Secretary, a plan concerning the monitoring and
regulation of such hemp production. State or Tribal plans must be
submitted to USDA and approved prior to their implementation. Nothing
preempts or limits any law of a State or Tribe that regulates the
production of hemp and is more stringent than the provisions in
Subtitle G of the AMA.
AMS received extensive public input on the regulatory requirements
for State and Tribal hemp plans. Incorporating the input received, the
following sections explain the changes to the regulatory requirements
for State and Tribal hemp plans.
A. Land Used for Production
The 2018 Farm Bill and the IFR required that plans include a
process by which relevant information regarding the land used for hemp
production in their jurisdiction is collected and maintained. Certain
information on mailing addresses and hemp production sites must be
collected for each licensee covered by the State or Tribal plan.
The information required to be collected includes a legal
description of the land and geospatial location for each field,
greenhouse, or other site where hemp is produced. Geospatial location
is necessary because many rural locations do not have specific
addresses, and these coordinates will assist with the proper
identification of hemp production locations.
In addition to the land information required to be collected by the
appropriate State or Indian Tribe, AMS chose to require licensed
producers, including those under the USDA plan, to report their hemp
crop acreage to the Farm Service Agency (FSA). Although many commenters
opposed this requirement based on costs around the time and travel
expense necessary to physically visit the appropriate FSA County
Office, AMS has determined that maintaining the FSA reporting
[[Page 5598]]
requirement is essential for several reasons. AMS recognizes that in
some cases producers may travel to FSA offices miles away incurring
additional time and cost. These costs are incorporated in the expected
burden of this program.
First, USDA is statutorily required to provide law enforcement with
certain ``real-time'' information about who is growing hemp, whether
their license is in good standing with the regulatory body issuing the
license, and the location(s) where hemp is being grown. Having FSA
collect the necessary information enables USDA to provide the most
accurate and ``real-time'' information to law enforcement, as required
by Subtitle G of the AMA. Second, FSA offices serve as useful resources
to all farmers and, in collaboration with other USDA agencies, can
provide a wide range of insurance, risk management, and conservation
program guidance and information. These offices currently serve the
agricultural industry within their communities, where producers can
establish farm and producer records, record their licensing
information, and report crop acreage. The producer may also, with
supporting documentation, update their FSA farm records for leases,
sub-leases, or land ownership. Requiring farmers to visit the FSA
office ensures that they receive information on the availability of
these helpful tools and programs. This is particularly important for
new farmers, who may not be aware of the wide range of programs and
services offered by USDA.
Further, FSA maintains the technology necessary for data collection
and geographical land identification. These tools will provide easy
access to information needed for law enforcement and for other
agricultural programs. AMS has determined, for these reasons, to
continue to require the reporting of hemp crop acreage to FSA.
Based on input from commenters, USDA is also clarifying the
distinction between the term ``lot'' as defined in the IFR, and the
term ``subfield'' as it relates to FSA reporting. Although this final
rule uses the term ``lot'' to discuss the land where hemp is grown,
when a producer visits the FSA office to report hemp crop acreage, FSA
staff will help producers determine the applicable FSA-specific term
for designating the location(s) where hemp is being grown. The
terminology used by FSA to denote land areas include terms like
``farm,'' ``tract,'' ``field,'' and ``subfield,'' which are equivalent
to AMS's term ``lot.'' FSA staff will not provide a ``lot number'' to
producers as described in the IFR. FSA will use designations that they
currently use such as track, field, or subfield, depending on the
specific area. This designation does not change the requirements or the
information submitted for law enforcement. AMS will amend the form to
reflect these terms. When reporting to FSA, producers must provide
their State or Tribe-issued license or authorization number. A link to
FSA information on how to report hemp crop acreage to FSA is available
at https://www.fsa.usda.gov/Assets/USDA-FSA-Public/usdafiles/FactSheets/2019/crop-acreage-reporting-19.pdf and is available on the
USDA hemp production program website.
As described in the IFR, certain State hemp pilot programs
operating under the 2014 Farm Bill authority developed ``seed
certification'' programs to help producers identify hemp strains with
potentially lower THC concentrations. The term ``certification'' in
this context means tested or verified, but it does not necessarily mean
certified for varietal purity. USDA acknowledges that this remains a
significant hurdle to the hemp industry and is committed to assisting
with the research and development of compliant hemp varietals. Although
AMS encourages States and Tribes to develop seed-certification programs
if sufficient data is available, AMS has determined, at this time, that
requiring the use of certain ``compliant'' varietals or establishing
National rules for State-level certification programs is inappropriate.
AMS will look at best practices from States and Tribes to evaluate if a
program would be applicable to a USDA plan. If applicable, USDA may
develop a performance-based sampling program. Such a program will
require USDA to conduct rulemaking and comment procedures.
The term ``seed certification,'' as found in the Federal Seed Act
and its Regulations, refers to a third-party verification process that
assures seed customers that they are receiving pure varieties and high-
quality seed for planting purposes. The Federal Seed Act grants
authority to seed certifying agencies in each State to administer
varietal seed certification standards for all major agricultural crops,
including hemp. Recognized seed certifying agencies are members of the
Association of Official Seed Certifying Agencies (AOSCA), and they
administer uniform AOSCA standards and inspect crops being grown for
seed throughout the production process to maintain varietal purity.
These activities protect seed customers in both domestic and export
markets. Seed produced under these types of certification programs
ensure a distinct, recognized variety that is properly tested and
legally labeled. Seed certification under the Federal Seed Act is
concerned with many varietal characteristics, not solely THC
concentration. This enables farmers to confidently purchase seed of a
suitable variety, by purchasing seed certified as to variety. Using
certified seed, as described in the Federal Seed Act regulations and
AOSCA standards, is an option for states and tribes if they have the
data to support that the seed would work in their environment. While
varietal certification does not absolutely ensure a specific THC
content, the fact is that THC content (or at least a range) is a
reliable varietal characteristic. Therefore, if the farmer is able to
confidently purchase seed of a suitable variety by purchasing seed
certified to variety, they at least know what to expect from the
variety in their area.
For this reason, AMS recommends the use of hemp seed from varieties
that have undergone varietal certification, following the process
outlined in the Federal Seed Act Regulations, and produced following
AOSCA standards. This recommendation will assist hemp farmers to
purchase recognized hemp varieties that have been tested for purity and
are properly labeled.
Additionally, AMS administers the Plant Variety Protection Office
(PVPO) that is actively accepting applications of seed-propagated hemp
for plant variety protection. The PVPO provides intellectual property
protection to breeders of new varieties of seeds, tubers, and asexually
reproduced plants. Under the U.S. Plant Variety Protection Act, PVPO
examines new applications and grants certificates that protect
varieties for 20 years (25 years for vines and trees). Certificate
owners have rights to exclude others from marketing and selling their
varieties, manage the use of their varieties by other breeders, and
enjoy legal protection of their work. This work, however, does not
certify seeds for THC content.
B. Tribal Jurisdictional Authority
The final rule clarifies the extent of a Tribe's regulatory
authority over hemp production within its Territory. Several commenters
stated that language in the IFR raised uncertainty as to whether Indian
Tribes could regulate hemp production by non-Indians operating on fee
lands within a Tribe's Territory. To address this uncertainty, Sec.
990.4(b)(4) of the final rule now provides that ``[u]pon USDA approval
of a Tribal plan, a Tribe may exercise jurisdiction and therefore
primary regulatory authority over all production of hemp in its
Territory regardless of the extent of its inherent
[[Page 5599]]
regulatory authority.'' Thus, as long as the land at issue qualifies as
land within the territory of an Indian Tribe under Sec. 990.1 of the
final rule, an Indian Tribe with a USDA-approved plan may regulate all
hemp production on that land. USDA determined that this additional
language is consistent with Congressional intent in the 2018 Farm Bill
and best ensures that hemp production is managed consistently
throughout the Territory of an Indian Tribe.
If an Indian Tribe desires to have primary regulatory authority
over the production of hemp in its Territory, under the 2018 Farm Bill,
the Tribe may submit a plan to USDA. Section 297C of the AMA provides
that ``In the case of a State or Indian Tribe for which a State or
Tribal plan is not approved under section 297B, the production of hemp
in that State or the territory of that Indian Tribe shall be subject to
a plan established by the Secretary to monitor and regulate that
production.'' Hence if a Tribe does not regulate hemp production within
its Tribal Territory, USDA, not a State with an approved plan, will
regulate hemp production program within that Territory.
Sections 297B and C plainly show that Congress chose to take a
territorial approach to the Tribal regulation of hemp production under
the AMA. If Congress only wanted Indian Tribes to assume primary
regulatory authority over hemp production in areas within their
inherent jurisdictional authority it could have stated this. Instead,
Congress opted for a land-based approach and delegated to Tribes the
authority to assume hemp production regulatory authority throughout
their territories. In consideration of the statutory language and the
overall statutory scheme of the 2018 Farm Bill, USDA has determined
that an Indian Tribe with an approved plan may regulate hemp production
throughout its territory without regard to the Indian Tribe's ability
to demonstrate inherent regulatory authority under the factors set
forth in Montana v. United States, 450 U.S. 544 (1981). Because
Congress did not define Territory of the Indian Tribe in the AMA and
did not include discussion in the legislative history of the meaning of
this term, USDA is exercising its authority to issue regulations to
implement the provisions in the 2018 Farm Bill to define this term in
this manner.
USDA's decision is in-line with agency determinations where the
agency determined that Congress delegated a Tribe with authority to
exercise regulatory authority over non-Tribal fee land within
reservations. EPA Interpretive Rule: Revised Interpretation of Clean
Water Act Tribal Provision, 81 FR 30183 (May 16, 2016); EPA Final Rule:
Indian Tribes--Air Quality Planning and Management, 63 FR 7254 (Feb.
12, 1998); Arizona Public Serv. Co. v. EPA, 211 F.3d 1280 (D.C. Cir.
2000).
Moreover, USDA's decision is practicable and prevents piecemeal
licensing by Tribes and USDA within a single Tribal Territory. If a
Tribe was only able to exercise primary regulatory authority over hemp
production within its Territory when it could demonstrate the inherent
authority to do so, USDA could be required to regulate some hemp
production within the Territory--for example, it could foreseeably be
required to regulate hemp production by non-Indians operating on fee
lands in certain cases. Such a system would be confusing for producers
and regulators alike.
For the foregoing reasons, the final rule now clearly explains that
upon USDA approval of a Tribal plan, a Tribe may exercise primary
regulatory authority over all production of hemp in its Territory
regardless of the extent of its inherent regulatory authority, as
reflected in Sec. Sec. 990.2 and 990.4 of the final rule.
C. Sampling for Total THC
AMS is changing certain aspects of the sampling requirements. This
section addresses performance-based sampling, how to sample hemp
plants, sampling agents, and the harvest window after sampling takes
place.
Sampling Requirements
AMS received significant input from commenters on how hemp sampling
procedures and requirements should be changed. When referring to
``sampling,'' we mean the process of collecting cuttings from hemp
plants for purposes of compliance testing.
Performance Based Sampling
The IFR required State and Tribal hemp programs to collect samples
from the flower material of the cannabis plant. The IFR also required
State and Tribal hemp programs to collect enough samples to ensure at a
confidence level of 95 percent that no more than one percent (1%) of
the plants in the lot would exceed the acceptable hemp THC level.
Guidance issued concurrently with the IFR explained these requirements
in greater detail. The sampling requirements in the IFR did not
consider geography, environmental factors, State or Tribal level seed
certification programs, or other factors faced by States and Tribes
when developing sampling requirements for their hemp programs. AMS is
modifying the sampling provisions as presented in the IFR to allow
States and Tribes to develop performance-based sampling requirements.
Performance-based sampling achieves defined objectives and focuses on
results. It differs significantly from a prescriptive action in which
licensees are provided detailed direction on how those results are to
be obtained. A performance-based approach would simply set a
performance objective (e.g., reliability of 95 percent) and allow the
States and Tribes considerable freedom in how to achieve that
reliability objective with their sampling methodology.
Some State hemp regulators have successfully developed sampling
requirements that ensure adherence to State and Federal regulations,
while allowing for flexibilities due to limited State resources and
State and Tribal differences. States expressed extensive concerns about
the requirements in the IFR that all lots must be sampled and tested,
due to significant logistical and fiscal impacts. They explained that,
since most hemp in a given region is harvested at the same time,
sampling must be completed within a very short time frame by only a few
individuals. Several States also explained how sampling occurs under
established State programs and described the different ways that
perceived risk determines State requirements. Some States utilize
different sampling requirements for broad end-use categories like
``fiber/grain'' hemp versus ``cannabinoid'' hemp, while others base
their requirements on historical THC concentrations of certain
varietals or on the characteristics and growing history of a certain
farm or producer. While these States' plans have not been approved
under the 2018 Farm Bill regulations, we believe that providing States
and Tribes the flexibility to develop sampling plans based on data they
gather during an extended period of time may be an effective method at
ensuring the overall acceptable hemp THC level of hemp grown in the
State or Tribe. AMS agrees that sampling requirements should allow
States and Indian Tribes more flexibility in the management of their
hemp regulatory programs.
AMS agrees that requiring sampling from every lot may be burdensome
and expensive for State and Tribal regulatory entities and producers.
AMS also finds compelling the arguments presented by States' regulatory
agencies and other commenters that there are different risk factors for
hemp used for fiber and grain versus hemp used for cannabinoids. Data
submitted with
[[Page 5600]]
comments show that the THC levels of hemp used for cannabinoids are
frequently higher than those of hemp for fiber and grain. The FDA
authorizes the marketing of few types of cannabinoid products. This
final rule does not cover cannabinoid products.
AMS also acknowledges that research institutions face special
circumstances when conducting hemp research. Accordingly, this rule
provides sampling and testing flexibility to these institutions and
producers working with them to conduct hemp research. Producers that
produce hemp for research, along with the research institution itself,
must obtain a license from a State, Tribal Government, or USDA.
However, the hemp that is produced for research is not subject to the
same sampling requirements provided that the producer adopts and
carries out an alternative sampling method that has the potential to
ensure, at a confidence level of 95 percent, that the cannabis plant
species Cannabis sativa L. that will be subject to this alternative
method will not test above the acceptable hemp THC level. Research
institutions and producers growing hemp for research purposes shall
ensure the disposal of all non-compliant plants. Research institutions
and producers growing hemp for research purposes shall also comply with
the reporting requirements including reporting disposal of non-
compliant plants. Research institutions that handle ``hot'' hemp must
follow CSA requirements for handling marijuana.
States and Indian Tribes are allowed to develop performance-based
requirements for these institutions. However, the alternative method
must have the potential to ensure, at a confidence level of 95 percent,
that the cannabis plant species Cannabis sativa L. that will be subject
to the alternative method will not test above the acceptable hemp THC
level.
AMS views this flexibility as necessary to help support research
and development as it relates to hemp production. This decision allows
these types of research facilities and institutions to confidently
oversee the study of hemp through trialing and genetics research, which
AMS believes to be critical to the growth of industry, particularly in
its infancy. Over time, the flexibility provided by this final rule
will help to stabilize industry by providing greater understanding of
hemp genetics and how certain varietals respond differently to growing
conditions in various geographic locations. All producers are expected
to benefit from such knowledge as they will be made aware of the more
stable and consistently reliable hemp varietals. Any non-compliant
plants produced by research institutions as a result of research and
development will still need to be disposed and verified through
documentation. Research and development facilities are still required
to be licensed by States and Tribes. Research institutions must follow
licensing and reporting requirements.
In performance-based approaches, measurable or calculable
parameters are available to determine whether the performance standard
is met. These performance parameters are identified to provide measures
of performance and the opportunity to take corrective action if
performance is lacking. In the case of hemp, the performance parameter
is the 0.3 percent THC level and other measures are included in this
final rule if the parameter is not achieved such as disposal and
remediation.
USDA finds that in order to increase regulatory effectiveness, it
makes sense to allow States and Indian Tribes to consider performance-
based alternatives when developing sampling plans. If the objective or
intended result can be achieved by setting a readily measurable
standard that is enforceable, the proposed requirement should merely
specify the objective or result to be obtained rather than prescribe to
the licensee how the objective or result is to be attained. In other
words, requirements should be performance-based, and highly
prescriptive rules and requirements should be avoided absent good cause
to the contrary.
The sampling requirements for State and Tribal plans allow for
States and Indian Tribes to develop unique sampling protocols for hemp
growing facilities under their jurisdiction. Sampling protocols must be
sufficient at a confidence level of 95 percent that no more than one
percent of the plants in each lot would exceed the acceptable hemp THC
level and ensure that a representative sample is collected that
represents a homogeneous composition of the lot. Alternatively, the
final rule allows States and Indian Tribes to adopt a performance-based
sampling protocol. A performance-based protocol must have the potential
to ensure, at a confidence level of 95 percent, that the cannabis
plants will not test above the acceptable hemp THC level. USDA
encourages the alternative protocol to consider seed certification
processes or process that identifies varieties that have consistently
demonstrated to result in compliant hemp plants in that State or
territory of the Indian Tribe, whether the producer is conducting
research on hemp at an institution of higher learning, whether a
producer has consistently produced compliant hemp plants over an
extended period of time, and other similar factors. AMS believes this
will provide needed flexibility to States and Indian Tribes to develop
logical and enforceable sampling requirements that take into
consideration their unique circumstances. AMS will still require States
and Indian Tribes to submit their individual sampling requirements for
review as a component of the plan approval process. Sampling protocols
submitted by States and Indian Tribes must comply with the thresholds
established by the 2018 Farm Bill and this final rule. If performance-
based sampling requirements are not included in a State or Tribal plan,
the method used for sampling must be sufficient at a confidence level
of 95 percent that no more than one percent of the plants in each lot
would exceed the acceptable hemp THC level and ensure that a
representative sample is collected from every lot, and thereby every
producer must be sampled and tested. When evaluating sampling protocols
submitted by States and Indian Tribes, USDA will evaluate the risk of
producing non-compliant material to determine approval or disapproval.
In evaluating the risk, USDA will take into consideration whether the
performance-based factors the State or Indian Tribe used have the
potential to assure compliance at a 95 percent confidence level.
Since USDA cannot develop performance metrics that would be
applicable independently from where the producer is located, producers
licensed under the USDA plan are subject to the sampling requirements
in the rule. USDA guidelines provided on the USDA website at https://www.ams.usda.gov/rules-regulations/hemp/information-sampling describe
best practices for complying with those requirements.
USDA recognizes that several States and Tribes may include
performance-based sampling in their plans and that their experience
could demonstrate that their sampling procedures may be adaptable to
the USDA plan. If USDA finds this to be the case, USDA will explore a
performance-based sampling scheme for producers under the USDA plan in
the future through notice and comment rulemaking.
Where To Take Samples on the Hemp Plant
AMS will retain the requirement that pre-harvest samples be taken
from the flower material of hemp plants. However, this rule clarifies
the number
[[Page 5601]]
of inches of plant material needed for the sample and provides greater
detail as to where exactly on the plant to make a cutting. The IFR
required that samples be taken from the ``flower material'' of hemp
plants. Further, in guidance material issued concurrently with the IFR,
AMS explained in greater detail where exactly on the plant to make a
cutting by recommending samples be taken from the top third of the
plant, ``just underneath a flowering material.'' Many commenters argued
that samples should be taken from the ``whole plant'' or that a
``homogenized'' sample should be taken to include the stem, stalk,
leaves, and seeds along with flower material. Alternatively, some
commenters proposed that samples be taken post-harvest from shredded
whole plant material, otherwise known as ``biomass.'' Advocates of
these positions asserted that THC levels of the whole hemp plant are
better represented by samples collected from the entire plant, and not
just from floral material. Other commenters advocated for sampling of a
certain size or length of cutting. Such commenters advocated adoption
of the sampling methods they or others had used under pilot programs.
Many State agriculture departments suggested AMS continue to require
samples taken from flower material.
Even though many commenters felt that whole plant sampling should
be allowed, AMS is of the opinion that since THC is concentrated in the
flower material of the plant, the flower material is more appropriate
to test than the entire plant. AMS will modify the sampling requirement
to state that the sample shall be approximately five to eight inches
from the ``main stem'' (that includes the leaves and flowers),
``terminal bud'' (that occurs at the end of a stem), or ``central
cola'' (cut stem that could develop into a bud) of the flowering top of
the plant. This change is consistent with the sampling practices in
several States that established hemp programs pursuant to the 2014 Farm
Bill authority. AMS determined that this standard strikes an
appropriate balance between the need to collect a sufficiently large
portion of the plant's flower (where THC and other cannabinoids are at
their most concentrated), and the need to avoid cutting a portion that
is so large that it would be logistically difficult to transport, dry,
and prepare for lab testing. Based on the information discussed above
and the experience and expertise of States and other commenters already
engaged in hemp production pursuant to the 2014 Farm Bill authority,
AMS is including new requirements herein.
AMS is publishing updated sampling guidance concurrently with this
final rule. This guidance describes how to comply with this requirement
regarding where to take the sample from the plant as well as other
sampling requirements in the final rule. While the sampling guidance
provides best practices for meeting the requirements, States, Indian
Tribes, and USDA licensees may adopt sampling procedures that differ
from the guidance so long as those procedures meet the standards in
this final rule.
Sampling Agents
The IFR required a Federal, State, local, or Tribal law enforcement
agency or other Federal, State, or Tribal designated person to collect
hemp samples for the purposes of testing THC levels in hemp. Comments
in response to the IFR presented several concepts concerning how
sampling agents should be designated and/or trained. Comments mostly
suggested the need for enhanced training requirements for sampling
agents to promote consistency in the ways that samples are collected
nationwide. Based on comments received regarding sampling agents, AMS
will provide additional training resources for sampling agents. These
training documents will explain how sampling agents can meet the
sampling requirements of this regulation. States and Indian Tribes with
an approved plan may require the sampling agents used in their
jurisdiction to take the USDA training, or they may develop their own
custom training incorporating USDA requirements with additional State
or Tribal requirements. States and Tribes must maintain information,
available to producers, about trained sampling agents.
Other comments on the topic of sampling agents spoke to the strain
on State and Tribal resources of requiring agents to take samples
instead of producers. Commenters presented two proposals to alleviate
this strain--allowing producers to collect their own samples and
reducing the volume of farms and plants from which samples are
collected. AMS is retaining the requirement that only designated agents
can collect samples. This ensures that there is consistency in sampling
throughout the industry. The flexibilities provided to States and
Indian Tribes with primary regulatory authority over hemp in their
jurisdiction will likely reduce the number of samples required to be
collected and thus reduce the burden on designated sampling agents.
Harvest Window
The IFR required harvest within 15 days of sampling. AMS received
comments regarding the challenges presented by the 15-day harvest
requirement, including the logistical challenges to State and Tribal
agencies charged with overseeing the collection of samples in this
short timeframe, the logistical challenges to producers in harvesting
hemp crops in this short timeframe, and testing challenges faced by
laboratories in having to conduct compliance analyses in this short
timeframe. Commenters suggested lengthening the 15-day harvest
requirement to a longer period of time--with some asking for up to 60
days.
AMS agrees with the arguments presented by commenters and
recognizes the challenges imposed on the industry by the 15-day harvest
requirement. AMS must also balance the logistical challenges of a
harvest window requirement with the fact that THC concentration in hemp
generally increases the longer the plant is in the ground. AMS now
understands from data provided in comments that THC concentration does
not increase linearly and is impacted by a myriad of environmental
factors including moisture, wind, temperature, disease, sunlight, and
soil, as discussed in the Comment Analysis section of this rule. The
regulatory objective is to ensure, as best as possible, harmonization
of the THC levels in the pre-harvest sample and that of the harvested
material. Requiring that samples be taken prior to harvest is the best
way to judge the THC concentration of the plant and the lot the sample
represents. AMS recognizes that the most accurate measurement would be
at time of harvest, but also understands the logistical practicalities
discussed above and therefore has determined the most balanced approach
is 30 days. For these reasons, AMS is expanding the window within hemp
must be harvested after sampling to 30 days.
Under this final rule, no more than 30 days prior to the
anticipated harvest of cannabis plants, a ``sampling agent'' must
collect samples for compliance testing. If producers do not harvest
within 30 days of sampling, the plant will likely have a higher THC
level at harvest than the sample that is being tested. This requirement
balances the need for accuracy with the logistical realities faced in
the sampling and testing processes and will yield the most accurate
measurement of the THC level at the point of harvest. Increasing the
window within hemp must be harvested after sampling from 15 to 30 days
will
[[Page 5602]]
better allow for variables such as testing, weather, agricultural
practices, and equipment delays.
D. Testing Laboratories
The IFR introduced regulatory requirements for laboratories testing
hemp for compliance purposes. AMS also issued guidance with the IFR to
explain best practices for hemp testing laboratories (www.ams.usda.gov/rules-regulations/hemp). Based on comments to the IFR, AMS is changing
certain parts of these regulations and updating the accompanying
testing guideline. While the testing guidance provides best practices
for meeting the regulatory requirements, States, Indian Tribes, and
USDA licensees may use test procedures that differ from the guidance so
long as those procedures meet the standards in the final rule.
Registration With DEA
The IFR required all hemp testing laboratories to be registered
with the DEA in accordance with the CSA (21 U.S.C. 823(f)). On February
27, 2020, AMS announced a delay in enforcement of this requirement
until October 31, 2020, or the publication of a final rule, whichever
came first (USDA, DEA Provide Options for Labs, Disposal of Non-
Compliant Hemp Plants. Thursday, Feb. 27, 2020) \4\ AMS announced this
enforcement delay to allow additional time to increase DEA registered
analytical lab capacity and avoid potential delays to producers in
receiving test results. Although AMS received comments in opposition to
this requirement, AMS is retaining the requirement in this final rule
that any laboratory testing hemp for purposes of regulatory compliance
must be registered with DEA to conduct chemical analysis of controlled
substances in accordance with 21 CFR 1301.13. This requirement also
applies to any laboratory testing hemp throughout the growing season to
informally monitor THC concentration. Registration is necessary because
laboratories could potentially handle cannabis that tests above 0.3
percent THC on a dry weight basis, which is, by definition, marijuana
and a Schedule 1 controlled substance. Instructions for laboratories to
obtain DEA registration, along with a list of approved laboratories,
are available on the USDA Domestic Hemp Production Program website. AMS
is aware that there are still not enough DEA-registered hemp testing
facilities in some States or territories of Indian Tribes. However,
since the IFR was published, numerous laboratories have applied for
registration and DEA is working diligently to process these requests.
Given the limited number of DEA-registered labs available to hemp
producers, delay in enforcement of this requirement is continued until
December 31, 2022. AMS anticipates this delay will provide adequate
time for testing facilities to obtain DEA registration.
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\4\ www.ams.usda.gov/press-release/usda-dea-provide-options-labs-disposal-non-compliant-hemp-plants.
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Laboratory Testing Requirements
Section 297B(a)(2)(A)(ii) of the AMA requires that State and Tribal
plans for primary regulatory jurisdiction include a ``procedure for
testing, using post-decarboxylation or other similarly reliable
methods, delta-9 tetrahydrocannabinol concentration levels of hemp
produced in the State or territory of the Indian Tribe.'' Since not all
testing methods include decarboxylation, AMS is requiring that the
total THC, which includes the potential conversion of
tetrahydrocannabinolic acid (THCA) into THC, be reported and used for
purposes of determining the THC content of a hemp sample.
The IFR included requirements on how laboratories conduct hemp
testing for the purposes of regulatory compliance to assure that total
THC levels were measured. Commenters provided extensive input on
testing requirements, particularly the requirement to test for
``total'' THC instead of only ``delta-9'' THC. AMS is retaining this
requirement.
AMS looked at current testing methodologies that would meet the
decarboxylation requirement set in the 2018 Farm Bill. In gas
chromatography (GC) testing, heat is applied to the sample, which
decarboxylates THCA, producing delta-9 THC, so that the final delta-9
THC result is actually a total THC result. GC is the more traditional
technique used for THC testing and was the technique used by Dr. Small
\5\ in his research that derived the 0.3 percent threshold that was
used as a basis for the 2018 Farm Bill requirement and is used by law
enforcement as the threshold to differentiate hemp from marijuana. In
his research papers, the 0.3 percent threshold is based on total
available delta-9 THC, which is the sum of THCA and delta-9 THC in the
plant material.
---------------------------------------------------------------------------
\5\ Small, E.; Beckstead, H.D.; Chan, A. The Evolution of
Cannabinoid Phenotypes in Cannabis. Economic Botany, 29, 219-232,
1975.
---------------------------------------------------------------------------
Liquid chromatography (LC) testing does not involve the use of
significant heat, so that the THCA in a sample does not generally
decarboxylate. Results can be reported for THCA and delta-9 THC
separately. When LC is used, the total THC needs to be calculated post-
testing in order to report results as a ``post-decarboxylation'' delta-
9 THC value. The requirement to report the total THC value as the THC
content regardless of testing methodology used ensures testing
consistency across the program.
Samples must be tested using post-decarboxylation or other
similarly reliable analytical methods by which the total THC
concentration level reported accounts for the conversion of THCA into
THC. Acceptable testing methodologies currently include gas or liquid
chromatography with detection.
The total THC, derived from the sum of the THC and THCA content,
shall be determined and reported on a dry weight basis. In order to
provide flexibility to States and Tribes in administering their own
hemp production programs, alternative testing protocols will be
considered if they are comparable to and similarly reliable as the
baseline mandated by section 297B(a)(2)(A)(ii) of the AMA and
established under USDA regulations and procedures. Updated USDA
procedures for sampling and testing will be issued concurrently with
this rule and will be provided on the USDA website.
Reporting requirements for laboratories are discussed later in
Section X (Regulatory Analysis) of this final rule. To clarify these
requirements, laboratories conducting testing for purposes of
monitoring THC concentration throughout the growing season are not
subject to these reporting requirements. These tests are for the
producer to monitor his or her production as it grows and not to comply
with pre-harvest testing requirements in this rule. Only laboratories
conducting the ``final'' test that will be used to determine whether a
sample is compliant are subject to reporting requirements.
Measurement of Uncertainty
This final rule requires that laboratories calculate and include
the Measurement of Uncertainty (MU) when they report THC test results.
``Measurement of uncertainty'' is defined as ``the parameter,
associated with the result of a measurement, that characterizes the
dispersion of the values that could reasonably be attributed to the
particular quantity subject to measurement.'' This definition is based
on the definition of ``uncertainty (of measurement)'' in section 2.2.3
of the Joint Committee for
[[Page 5603]]
Guides in Metrology \6\ 100:800, Evaluation of measurement data--
``Guide to the Expression of Uncertainty in Measurement'' (JCGM Guide).
The National Institute of Standards and Technology (NIST) Technical
Note 1297, ``Guidelines for Evaluating and Expressing the Uncertainty
of NIST Measurement Results'' (TN 1297), is based on the JCGM Guide.
AMS also relied on the Eurachem/Co-Operation on International
Traceability in Analytical Chemistry's ``Guide on Use of Uncertainty
Information in Compliance Assessment, First Edition 2007''.
Colloquially, the measurement of uncertainty is similar to a margin of
error. When the measurement of uncertainty, normally expressed as a +/-
with a number (e.g. +/- 0.05), is combined with the reported
measurement, it produces a range, and the actual measurement has a
known probability of falling within that range (typically 95%).
Laboratories should meet the AOAC International \7\ standard method
performance requirements for selecting an appropriate method to
determine the MU.
---------------------------------------------------------------------------
\6\ The Joint Committee for Guides in Metrology is composed of
international organizations working in the field of metrology. Its
membership includes the Bureau International des Poids et Mesures,
the Organisation Internationale de M[eacute]trologie L[eacute]gale,
the International Organization for Standardization, the
International Electrotechnical Commission, the International Union
of Pure and Applied Chemistry, the International Union of Pure and
Applied Physics, the International Federation of Clinical Chemistry
and Laboratory Medicine, and the International Laboratory
Accreditation Cooperation.
\7\ USDA established the Association of Official Agricultural
Chemists in 1884. In 1965, it changed its name to the Association of
Official Analytical Chemists and became an independent organization
in 1979. In 1991, it adopted its current, legal name as AOAC
International.
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This final rule requires that laboratories report the MU as part of
any hemp test results. The rule also includes a definition of
``acceptable hemp THC level'' to account for the uncertainty in the
test results. The reported THC concentration of a sample may not be the
actual concentration level in the sample. However, the actual THC
concentration is expected to be within the distribution or range
calculated when the reported THC concentration is combined with the
measurement of uncertainty.
The use of MU for purposes of determining the acceptable hemp THC
level does not alter Federal law with regard to the definition of hemp
or marijuana. As stated above, the 2018 Farm Bill defines hemp 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 THC of not more than 0.3 percent on a dry weight basis.
Likewise, the Federal (CSA) definition of marijuana continues to
include those parts of the cannabis plant as specified in 21 U.S.C.
802(16) (and derivatives thereof) that contain more than 0.3 percent
THC on a dry weight basis. The foregoing provisions of Federal law
remain in effect for purposes of Federal criminal prosecutions, as well
as Federal, civil, and administrative proceedings arising under the
CSA.
The definition of ``acceptable hemp THC level'' is also retained in
this final rule. States and Indian Tribes shall adopt this concept in
their plans. This definition explains how to interpret test results
that include the MU with an example. The application of the MU to the
reported delta-9 tetrahydrocannabinol concentration on a dry weight
basis produces a distribution, or range. If 0.3 percent or less is
within the distribution or range, then the sample will be considered to
be hemp for the purpose of compliance with the requirements of State,
Tribal, or USDA hemp plans. For example, if a laboratory reports a
result as 0.35 percent with a measurement of uncertainty of +/-0.06,
the distribution or range is 0.29 percent to 0.41percent. Because 0.3
percent is within that distribution or range, the sample, and the lot
it represents, is considered hemp for the purpose of compliance with
the requirements of State, Tribal, or USDA hemp plans. However, if the
MU for that sample was 0.02 percent, the distribution or range is 0.33
percent to 0.37 percent. Because 0.3 percent or less is not within that
distribution or range, the sample is not considered hemp for the
purpose of plan compliance, and the lot it represents will be subject
to disposal. Thus the ``acceptable hemp THC level'' is the application
of the MU to the reported delta-9 tetrahydrocannabinol content on a dry
weight basis producing a distribution or range that includes 0.3
percent or less. As such, the regulatory definition of ``acceptable
hemp THC level'' describes how State, Tribal, and USDA plans must
account for uncertainty in test results in their treatment of cannabis.
This definition affects neither the statutory definition of hemp, 7
U.S.C. 1639o(1), in the 2018 Farm Bill nor the definition of
``marihuana,'' 21 U.S.C. 802(16), in the CSA.
Sections 297B(a)(2)(A)(iii) and 297C(a)(2)(C) of the AMA require
that cannabis plants that have a THC concentration level of greater
than 0.3 percent on a dry weight basis be disposed of in accordance
with the applicable State, Tribal, or USDA plan. Because of this
requirement, producers whose cannabis crop is not hemp will likely lose
most of the economic value of their investment. Thus, AMS believes that
there must be a high degree of certainty that the THC concentration
level is accurately measured and is in fact above 0.3 percent on a dry
weight basis before requiring disposal of the crop.
The NIST Reference on Constants, Units, and Uncertainty states that
``measurement result is complete only when accompanied by a
quantitative statement of its uncertainty. The uncertainty is required
in order to decide if the result is adequate for its intended purpose
and to ascertain if it is consistent with other similar results.'' \8\
Simply stated, knowing the measurement of uncertainty is necessary to
evaluate the accuracy of test results.
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\8\ https://physics.nist.gov/cuu/Uncertainty/international1.html.
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Comments to the IFR generally expressed support for requiring that
the measurement of uncertainty (MU) be accounted for when testing the
THC concentration of hemp, due to the variability in laboratory testing
equipment and complex mathematical principles involved. Comments also
provided several suggestions on ways to improve the calculation of MU.
Many comments advocated specifying an MU to create uniformity in
testing across the nation.
USDA does not recommend establishing an MU upper limit (maximum)
because (1) MU is typically not standardized, but is controlled using
standard test methods, and (2) USDA does not have the data to set an
upper limit so setting it would be arbitrary, not scientific. The hemp
and scientific industries are just beginning to discuss standard test
methods and the final rule does not establish an explicit test method.
Setting an upper limit or maximum MU does not resolve the core issue
and would not encourage or drive labs to improve accuracy and
precision.
Setting an upper limit would in effect be setting a maximum or
absolute MU. This may encourage labs to adopt the maximum MU as their
MU, rather than drive for a smaller uncertainty. USDA may allow for
establishing limits in the future, if needed, once methods are
established and USDA has access to Proficiency Testing results and the
reported MUs. We encourage States and Tribes to monitor, review and
evaluate MU to evaluate trends and outliers, which may indicate ``lab
shopping'' for higher MUs. The requirement for hemp
[[Page 5604]]
testing laboratories to incorporate a MU is being retained in this
regulation.
Laboratory Accreditation
In the IFR, AMS requested input on establishing a fee-for-service
hemp laboratory approval process or a requirement for laboratories to
obtain ISO 17025 accreditation for labs that wish to offer THC testing
services. Comments reflected a range of views across the industry, both
in support of and in opposition to additional laboratory certification
requirements. In general, commenters preferred more regulatory
flexibility to address the widespread concern of insufficient
laboratory capacity as a result of laboratory certification/
registration/accreditation requirements. Other commenters were opposed
to accreditation requirements due to the cost. While AMS strongly
encourages laboratories to be accredited to ISO/IEC 17025 (by an
International Laboratory Accreditation Cooperation Mutual Recognition
Agreement (ILAC MRA) signatory accreditation body), we also acknowledge
that ISO 17025 accreditation requires significant time and financial
commitment to pursue and maintain. The time and cost involved is most
challenging for smaller and start-up labs. The initial accreditation
can cost $5,000-$10,000 (and in some case more) and yearly ongoing
costs are $3,000-$8,000. Smaller labs may not have the resources to
pursue accreditation in a timely manner or they may have to spend
additional time and money for consultants to assist them in setting up
a quality management system and to navigate the application and audit
processes.
Based on insufficient laboratory capacity at this time and the cost
involved in adding this requirement, AMS will not provide an AMS
administered lab approval program or require ISO 17025 accreditation.
However, AMS remains committed to assisting the hemp laboratory testing
community and is available to assist in the development of a laboratory
approval program in the future. As explained in the IFR, if such hemp
laboratory approval program is developed by AMS, such process will be
conducted by USDA, AMS Laboratory Approval Service, which administers
the Laboratory Approval Program (LAP). State and Tribal plans are free
to include certain additional requirements for hemp testing
laboratories, including ISO accreditation or other proficiency schemes.
E. Disposal and Remediation of Non-Compliant Plants
State and Tribal plans are currently required to include procedures
for ensuring effective disposal or remediation of plants produced in
violation of part 990. Plants that are removed as a result of poor
plant health, pests, disease, or weather events, along with removal of
male or hermaphrodite plants as part of a cross-pollination prevention
plan, are not subject to the disposal requirements herein. This final
rule retains the disposal requirements explained in the IFR but
clarifies what ``disposal'' means and explains how the process must be
conducted. This final rule also includes remediation as an option to
remove non-compliant plants.
As explained in the IFR, if a producer grows cannabis exceeding the
legal 0.3 percent THC level, the material must be disposed of in
accordance with the CSA and DEA regulations because such material
constitutes marijuana, a Schedule I controlled substance under the CSA.
The material must be collected for disposal by a person authorized
under the CSA to handle marijuana, such as a DEA-registered reverse
distributor, or a duly authorized Federal, State, Tribal, or local law
enforcement officer. In the final rule, AMS is incorporating
flexibilities for disposal that were announced on February 27, 2020
(https://www.ams.usda.gov/rules-regulations/hemp/enforcement). Some of
these new options include, but are not limited to, plowing under non-
compliant plants, composting into ``green manure'' for use on the same
land, tilling, disking, burial, or burning. These methods are intended
to allow producers to apply common on-farm practices for the disposal
of non-compliant plants. One of the top considerations in making this
change was to minimize, to the extent possible, the resource impact to
State, Tribal, and local law enforcement in handling hemp that is out
of compliance. In addition, we are confident that any disposal options
make the product unusable and therefore is not at risk for entering any
streams of commerce. Based on comments received, AMS is permanently
retaining these on-farm disposal flexibilities.
AMS received comments on this requirement describing the expense
associated with destroying cannabis in accordance with the CSA,
primarily the requirement that disposal be conducted offsite by a
reverse distributor or other law enforcement officer. Based on this
input, AMS, in coordination with DEA partners, delayed enforcement of
the disposal requirements in the IFR. In the final rule, producers have
several options on how to handle non-compliant plants. Producers do not
need to use a DEA-registered reverse distributor or law enforcement to
dispose of non-compliant plants. Producers may dispose of the plants
using one or more of the means described by AMS at https://www.ams.usda.gov/rules-regulations/hemp/disposal-activities. It is the
Agency's intent that these methods allow producers to apply common on-
farm practices as a means of disposal while rendering the controlled
substance non-retrievable or non-ingestible. Under this final rule,
State and Tribal plans must still include procedures to verify
disposal. This may come in the form of in-person verification by State
or Tribal representatives, or alternative requirements the direct
growers to provide pictures, videos, or other proof that disposal
occurred successfully. Producers under the USDA plan must document the
disposal of all non-compliant plants. States and Indian Tribes
operating under approved hemp production plans and producers under the
USDA plan must notify USDA of any occurrence of non-conforming plants
or plant material and provide the disposal record of those plants and
materials monthly.
State and Tribal plans must include procedures to verify disposal,
whether through the use of in-person verification by State or Tribal
representatives, or requirements for producers to provide pictures,
videos, or other proof that disposal did in fact occur. State and
Tribal plans must also include requirements to submit to AMS the
monthly disposal and remediation report documenting any on-farm
disposals or remediations that occurred during the prior month. As of
November 2020, twenty States and nine Tribes operating under the 2018
Farm Bill reported 4,192 licensed producers representing 6,166 acres
planted. Of these acres planted, there were 231 disposals representing
730 acres disposed due to not meeting the 0.3 percent acceptable hemp
THC level.
AMS did not provide additional remediation options in the IFR. The
only remediation alternative was to completely dispose of the non-
compliant material. AMS is adding remediation to this final rule based
on comment. AMS received many comments suggesting the inclusion of
procedures to allow for non-compliant cannabis to be ``remediated.''
AMS agrees with this suggestion and is publishing remediation
techniques concurrently with this rule that can be
[[Page 5605]]
followed to remediate non-compliant plant material into compliant form.
As described in the IFR, hemp exceeding the acceptable THC level may
not be further handled, processed, or enter the stream of commerce. AMS
believes that hemp producers should have the opportunity to remediate
non-compliant crops in order to minimize financial risk associated with
the loss of investment in their hemp crop. For this reason, this final
rule allows remediation activities, either disposing of flower
materials and salvaging the remainder of the plant or blending the
entire plant into biomass plant material. Through both forms of
remediation, producers may be able to minimize losses, and in some
cases produce a return on investment while ensuring that non-compliant
material does not enter commerce.
If a producer elects to perform remediation activities as allowable
under this final rule's provisions (referenced above), an additional
sampling and testing of the post-remediated crop must occur to
determine THC concentration levels. Only those successfully remediated
crops will be allowed to enter the stream of commerce, and all other
remaining non-compliant crops must then be disposed.
AMS believes the inclusion of remediation and post-harvest sampling
into the final rule provides the additional flexibility requested by
commenters that expressed the need for producers to have greater
opportunity for success as established and beginning farmers entering
hemp production.
F. Compliance With Enforcement Procedures, Including Determination of
Negligence and Annual Inspection of Hemp Producers
The IFR required State and Tribal plans to include compliance
procedures to ensure hemp was being produced in accordance with the
requirements of this part. Comments to the IFR were generally opposed
to the compliance requirements, particularly as they relate to the
definition of negligence. Producers, along with State and Tribal
regulatory agencies, found the negligence requirements in the IFR
overly harsh and strict. This final rule changes these compliance
procedures, particularly how ``negligence'' is determined. In the
context of this regulation, negligence is defined as a failure to
exercise the level of care that a reasonably prudent person would
exercise in complying with the regulation. The definition employed in
this rule is derived from the definition of negligence in Black's Law
Dictionary. See BLACK'S LAW DICTIONARY (10th ed. 2014) (defining
negligence as ``[t]he failure to exercise the standard of care that a
reasonably prudent person would have exercised in a similar
situation'').
This final rule increases the negligence threshold from 0.5 to 1.0
percent THC and clarifies how States and Indian Tribes determine when
to suspend or revoke a producer's license. AMS believes that raising
the negligence threshold from 0.5 percent to 1.0 percent THC will
increase flexibility to farmers as they learn more about how to grow
compliant hemp and as the availability of stable hemp genetics
improves. In developing the compliance requirements for State and
Tribal plans, AMS recognizes that there may be significant differences
across States and Indian Tribes in how they will administer their
respective hemp programs. This final rule provides that a producer
shall not be subject to more than one negligent violation per calendar
year.
State and Tribal hemp plans must still include requirements to
conduct annual inspections of, at a minimum, a random sample of hemp
producers to verify hemp is not being produced in violation of this
rule, along with a procedure for handling violations.
In accordance with the 2018 Farm Bill, States and Indian Tribes
with their own hemp production plans have certain flexibilities in
determining whether hemp producers have violated their approved plans.
However, there are certain compliance requirements that all State and
Tribal plans must contain. This includes procedures to identify and
attempt to correct certain negligent acts, such as failing to provide a
legal description of the land on which the hemp is produced, not
obtaining a license or other required authorizations from the State or
Tribal government, or producing plants exceeding 0.3 percent total THC.
States and Indian Tribes may include additional requirements in their
plans.
This final rule specifies 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 1.0 percent on a dry
weight basis. AMS recognizes that hemp producers may take the necessary
steps and precautions to produce hemp, such as using certified seed,
using other seed that has reliably grown compliant plants in other
parts of the country, or engaging in other best practices, yet still
produce plants that exceed the acceptable hemp THC level. AMS believes
that a hemp producer in that scenario has exercised a level of care
that a reasonably prudent person would exercise if the plant does not
have a THC concentration of more than 1.0 percent on a dry weight
basis. AMS arrived at this increased tolerance based on input from
commenters, particularly State agriculture departments that operated
hemp research programs under the 2014 Farm Bill, along with data
provided by laboratories testing hemp subject to 2018 Farm Bill
requirements. The 0.5 percent was based on data from three states
participating in the 2014 Farm Bill pilot program. AMS believes raising
the negligent violation threshold from 0.5 percent to 1.0 percent in
the final rule provides a greater buffer and reduces farmers' exposure
to risk of violation accrual and license suspension.
AMS recognizes the violation threshold may incentivize (or
disincentivize) innovation by research institutions and producers. AMS
acknowledges more innovation and research across industry will bring
more stability to stakeholders. AMS believes the 1.0 percent threshold
incentivizes innovation across industry more so than a 0.5 percent
violation threshold. Further, comments addressed the negative impact of
the accrual of negligent violations on the financial stability of the
individual business. They described how a hemp grower's access to
credit and insurance is jeopardized when negligent violations
accumulate and lead to a determination of culpable negligence. Comments
explained that lending institutions and insurance providers look for
risk factors. They also raised questions about how the accrual of
negligent violations may be interpreted by lender or providers.
Comments said that many insurers will not cover crop losses if losses
are due to the growers' negligence.
AMS acknowledges institutional lenders view violations as risk
factors in decision making. AMS also notes that not all culpable
violations are derived from the accrual of negligent violations.
Culpable violations may be the result of producers violating other
parts of the 2018 Farm Bill. However, the 2018 Farm Bill explicitly
considers certain actions as constituting negligent violations. AMS's
intention is to provide a threshold between 0.3 percent THC level and
what would be considered a negligent violation so not all hemp that
tests over the 0.3 percent be considered a negligent violation. Because
a producer will not have committed a negligent violation every time he
or she grows hemp with a concentration of hemp above the 0.3 percent
level, this will assist producers when requesting loans or other
financial assistance.
[[Page 5606]]
Several comments suggested that a 0.5 percent negligence threshold
threatens the survival of farmers in an emerging industry. Comments
suggested that the low threshold is a barrier to entry for new farmers
or farmers with no experience growing hemp, who risk high initial
capital investments to establish operations. Comments argued that the
low threshold favors larger farms using industrialized hemp varieties
and production practices, and that the low negligence threshold in the
IFR would unnecessarily criminalize farmers working with a legal
agricultural commodity. Increasing this threshold to 1.0 percent
benefits producers, including small and new farmers, that intended to
grow hemp but whose crops tested ``hot'' even though they made
reasonable efforts to grow hemp.
In cases where a State or Indian Tribe determines a negligent
violation has occurred, a corrective action plan shall be established.
The corrective action plan must include a reasonable date by which the
producer will correct the negligent violation. Producers operating
under a corrective action plan must also periodically report to the
State or Tribal government, as applicable, on their compliance with the
plan for a period of not less than two calendar years following the
violation. A producer who negligently violates a State or Tribal plan
three times in a five-year period will be ineligible to produce hemp
for a period of five years from the date of the third violation.
Several comments explained how these requirements as written in the
IFR were confusing and difficult to administer. Particularly,
commenters explained how a producer could easily receive three
negligent violations during one growing season, which would lead to an
automatic licensing revocation for the following five years. For
example, a producer may grow hemp in three different locations. If the
hemp becomes non-compliant cannabis, all in one season, the producer
would lose the license in one season. Commenters described this as too
strict and too severe a penalty for honest mistakes that many first-
year hemp producers will certainly make. AMS agrees and wishes to
clarify that this is not the intent of the regulation. AMS acknowledges
that producers may have more than one production area and that they may
harvest at different times. Tests results may be over the allowable
limit on those production areas but the planting was performed at the
same time using the same seeds. Allowing for only one violation per
season would help minimize duplication of enforcement. This final rule
provides that a producer shall not be subject to more than one
negligent violation per calendar year. As it is customary in
agriculture, practices vary due to many factors such as weather,
availability of labor, transportation and storage capacity and more.
Due to many factors, producers make determinations about planting and
harvest cycles. In certain circumstances, producers may plant before
the first cycle has been harvested specially when they plant in
multiple locations. Calendar year is easier to administer and will
allow for various growing seasons.
Each geographical area has a growing season based on specific
temperature, weather, soil or other factors in that region, therefore
this rule is defining growing season as a calendar year. This will
allow flexibility, including a year-round season if States and Indian
Tribes have a warmer climate or greenhouse growing.
Negligent violations are still not subject to criminal enforcement
action by local, Tribal, State, or Federal government authorities under
this regulation.
State and Tribal plans also must contain provisions relating to
producer violations made with a culpable mental state greater than
negligence, meaning acts made intentionally, knowingly, or with
recklessness. This definition is derived from the definition of
negligence in Black's Law Dictionary. See BLACK'S LAW DICTIONARY (10th
ed. 2014) (giving as a definition of negligence ``[t]he failure to
exercise the standard of care that a reasonably prudent person would
have exercised in a similar situation''). If it is determined a
violation was committed with a culpable mental state greater than
negligence, the State agriculture department or Tribal government, as
applicable, shall immediately report the producer to the Attorney
General, USDA, and the chief law enforcement officer of the State or
Indian Tribe.
State and Tribal plans also must prohibit any person convicted of a
felony related to a controlled substance under State or Federal law
from participating in the State or Tribal plan and from producing hemp
for 10-years following the date of conviction. An exception applies to
a person who was lawfully growing hemp under the 2014 Farm Bill before
December 20, 2018, and whose conviction also occurred before that date.
This exemption language must be included in all State and Tribal hemp
plans, whether they administered a 2014 Farm Bill research pilot
program or not.
The 2018 Farm Bill does not define what it means to ``participate
in the [State or Tribal] program.'' AMS is not requiring States and
Indian Tribes to adopt a specific definition. Instead, they must define
who those persons are in their plan. The definition must include one
individual for whom a criminal history records check can be conducted
for each license or authorization that the State or Indian Tribe
issues. The final rule identifies and defines ``key participants'' as
those participating in the USDA plan. State and Tribes may, but are not
required, to adopt this definition for their plans.
The State or Indian Tribe will need to review criminal history
reports for each individual identified as participating in its program.
The final rules defines ``criminal history report'' as the Federal
Bureau of Investigation's Identity History Summary. The State or Indian
Tribe may review additional reports or checks to determine whether an
individual may participate in its plan. Finally, any person found by
the USDA, State, or Tribal government to have materially falsified any
information submitted to the program will be ineligible to participate.
G. Information Sharing
The IFR included requirements for State and Tribal plans to contain
procedures for reporting specific information to USDA. Limited comments
were received on these requirements. This information has been
transmitted already by many States and Tribes to USDA. This information
meets the requirements set in the 2018 Farm Bill. Therefore, the
following requirements are the same as required under the IFR and are
in subpart F of this final rule. This is separate from the requirement
to report hemp crop acreage with FSA as discussed above.
The information required includes contact information for each hemp
producer covered under the plan, including name, address, telephone
number, and email address (if available). If the producer is a business
entity, the information must include the full name of the business,
address of the principal business location, full name and title of each
employee for whom the entity is required to submit a criminal history
report, and an email address if available, and Employee Identification
Number (``EIN'') of the business entity. Producers must report the
legal description and geospatial location for each hemp production
area, including each field, greenhouse, or other site used by them, as
stated in section A of this preamble. The report also shall include the
status of the license or other
[[Page 5607]]
required authorization from the State or Tribal government, as
applicable, for each producer under a hemp production plan. States and
Indian Tribes will submit this information to USDA not later than 30
days after the date it is received using the appropriate reporting
requirements as determined by USDA.
These reporting requirements are found at Sec. 990.70 in this
final rule. Further explanation of the specific information to be
submitted, the appropriate format, and the specific due dates for the
information is discussed in Section X (Regulatory Analysis) of this
final rule. This information submitted from each State and Tribal plan,
along with the equivalent information collected from individuals
participating under the USDA plan, will be assembled and maintained by
USDA and made available in real time to Federal, State, Tribal, and
local law enforcement, as required by the 2018 Farm Bill. All
information supporting, verifying, or documenting the information
submitted to USDA must be maintained by the States and Indian Tribes
for at least three years.
Under Sec. 990.70(c), States and Indian Tribes must also submit
annual reports regarding the total planted, harvested, and disposed
acreage. Additionally, because the final rule provides for remediation
of plants, the final rule requires all remediated acreage to be
reported as well. Similarly, under Sec. 990.71(c), all USDA hemp plan
producers must submit annual reports to USDA detailing total planted
acreage, total acreage disposed and remediated, and total harvested
acreage.
H. Certification of Resources
All State and Tribal plans submitted for USDA approval must also
have a certification stating the State or Indian Tribe has the
resources and personnel necessary to carry out the practices and
procedures described in their plan. Section 297B of the AMA requires
this certification, and the information is important to USDA's approval
of State and Tribal plans, in that all such plans must be supported by
adequate resources to effectively administer them. This section has not
changed from the IFR.
I. State and Tribal Plan Approval, Technical Assistance and USDA
Oversight
Since the publication of the IFR, AMS has worked extensively with
States and Indian Tribes in developing hemp production plans. As States
and Indian Tribes begin the work of modifying their plans to
incorporate the changes herein, we encourage States and Indian Tribes
to continue working with and sharing information with AMS. States and
Tribes may need to change plans based on changes in this final rule
because their State or Tribal laws may no longer match the requirements
in this final rule. Even though some of the changes in this final rule
are less burdensome, State and Tribal plans must follow their own
legislations. Accordingly. They must amend their plans. During the plan
development and/or revision process, States and Indian Tribes are
encouraged to contact USDA so we may provide technical assistance in
developing plan specifics. Since the publication of the IFR, USDA
approved over 60 State and Tribal plans within the 60-day requirement.
USDA approved plans that comply with the 2018 Farm Bill and with the
provisions of the IFR. For the 2021 planting season, the 2018 Farm
Bill, amended by the Continuing Resolution (CR) (Agriculture
Improvement Act of 2018 (7 U.S.C. 5940 note; Pub. L. 116-260)),
provided that States and institutions of higher education can continue
operating under the authorities of the 2014 Farm Bill until January 1,
2022. AMS clarified the avenues for Tribal participation under
authorities in the 2014 Farm Bill to grow industrial hemp for research
purposes. This clarification is available on the AMS website: https://www.ams.usda.gov/content/usda-clarifies-industrial-hemp-production-indian-Tribes.
Due to this extension, many States decided to remain under the 2014
Farm Bill provisions and rescinded their previously approved plans. All
States are eligible to remain or start programs under the 2014 Farm
Bill provisions. As a result, USDA will oversee 20 State and 20 Tribal
plans under the 2018 Farm Bill until new States and Tribes submit more
plans under the 2018 Farm Bill provisions.
As of November 2020, States and Tribes operating under the 2018
Farm Bill reported 4,192 licensed producers representing 6,166 acres
planted. Of these acres planted, there were 231 disposals representing
730 acres disposed due to not meeting the 0.3 percent acceptable hemp
THC level. This data is limited because even though many States and
Tribes have approved plans, they have not all been fully implemented.
USDA expects more data will be available as the 2021 season begins and
States and Tribes implement their programs.
USDA will use the procedures in this rule, which are substantively
similar to those in the IFR, to review and approve State and Tribal
plans. If a plan does not comply with the requirements of the Act and
this regulation, it will not be approved. However, USDA has worked with
many States and Tribes submitting plans to assist them in meeting the
requirements and obtaining approval for their plans.
If a plan is not approved, USDA provides a letter of notification
outlining the deficiencies identified. The State or Tribal government
may then submit an amended plan for review. If the State or Tribe
disagrees with the determination made by USDA regarding the plan, a
request for reconsideration can be submitted to USDA using the appeal
process as outlined in section V of this document. Plans submitted by
States and Indian Tribes must be approved by USDA before they can be
implemented.
States and Indian Tribes can submit their plans to USDA through
electronic mail at [email protected] or by postal carrier to USDA.
The specific mailing address is provided on the USDA Domestic Hemp
Production Program website.
If the State or Tribal plan application is complete and meets the
criteria of this part, USDA issues an approval letter. Approved State
and Tribal plans, including their respective rules, regulations, and
procedures, are posted on USDA's hemp program website.
A USDA-approved State or Tribal plan will remain in effect, unless
approval is revoked by USDA pursuant to the revocation procedures
discussed in this section or unless the State or Tribe makes
substantive revisions to their plan or their laws that alter the way
the plan meets the requirements of this regulation. Additionally,
changes to the provisions or procedures under this rule or to the
language in the 2018 Farm Bill may require plan revision and
resubmission to USDA for approval. Changes to applicable Federal and
State or Tribal statutes may also require plan revision and
resubmission to USDA for approval and may lead to plan revocation if
the plan is not amended. Should States or Indian Tribes have questions
regarding the need to resubmit their plans, they should contact USDA
for guidance.
A State or Tribal government may submit an amended plan to USDA for
approval if: (1) The Secretary disapproves a State or Tribal plan; or
(2) the State or Tribe makes substantive revisions to their plan or to
their laws that alter the way the plan meets the requirements of this
regulation, or as necessary to bring the plan into compliance with
changes in other applicable law or regulations.
If the plan previously approved by USDA needs to be amended because
of
[[Page 5608]]
changes to the State's or Tribe's laws or regulations, such
resubmissions should be provided to USDA within 60 days from when the
new State or Tribal law or regulations are effective. Producers will be
held to the requirements of the previous plan until such modifications
are approved by USDA. If State or Tribal government regulations in
effect under the USDA-approved plan change, but the State or Tribal
government does not resubmit a modified plan within 60 days of the
effective date of the change, USDA will issue a notification to the
State or Tribal government that approval of its plan will be revoked.
The revocation will be effective no earlier than the beginning of the
next calendar year. If a plan is revoked, producers previously subject
to an approved plan would be eligible to apply to USDA for a license.
This is a change from the IFR that allowed for resubmission because of
a change in State or Tribal law or regulations within a calendar year.
This modification is due to USDA's need to know in a timelier manner,
since such laws and regulations are the foundations of the hemp plans.
The words of the plans do not have meaning if they are not aligned with
current authorities.
USDA has the authority to audit States and Tribes to determine if
they are in compliance with the terms and conditions of their approved
plans. If a State or Indian Tribe is noncompliant with their plan, USDA
will work with that State or Indian Tribe to develop a corrective
action plan. However, if additional instances of noncompliance occur,
USDA has the authority to revoke the approval of the State or Tribal
plan for one year or until the State or Tribe become compliant. AMS
still believes that one year is sufficient time for a noncompliant
State or Indian Tribe to evaluate problems with their plan and make the
necessary adjustments. Should USDA determine the approval of a State or
Tribal plan should be revoked, such a revocation would begin after the
end of the current calendar year, so producers will have the
opportunity to adjust their operations as necessary. This will allow
producers to apply for a license under the USDA plan so that their
operations do not become disrupted due to the revocation of the State
or Tribal plan.
III. Department of Agriculture Plan
The 2018 Farm Bill requires USDA to administer a hemp production
plan for producers in jurisdictions where hemp production is legal but
is not covered by an approved State or Tribal plan. The USDA licensing
remains available to producers in States and Tribal territories without
a USDA-approved hemp plan. All hemp produced in a jurisdiction without
an approved State or Tribal plan must meet the requirements of the USDA
plan. The requirements for producers operating under the USDA plan are
similar to those operating under approved State and Tribal plans.
Regulatory requirements for producers licensed under the USDA plan
in this final rule differ in some cases from corresponding requirements
in the IFR and are explained in the following section. Comments
submitted to the IFR generally did not address these requirements
specifically; rather they focused on the broader requirements around
sampling, testing, and disposal, to which all hemp producers are
subject, whether licensed by a State, a Tribe, or USDA.
A. USDA Hemp Producer License and Criminal History Report
To produce hemp under the USDA plan, producers must apply for and
be issued a license from USDA. USDA has been accepting applications
from producers since October 2019. Any license issued by USDA prior to
publication of this final rule will remain in effect and subject to the
original expiration date. As of the issuance of this final rule, USDA
has issued 380 licenses under the USDA plan.
While a State or Tribal government has a draft hemp production plan
pending for USDA approval, USDA will not issue USDA hemp production
licenses to individual producers located within that State or Tribal
territory. Once USDA approves a hemp production plan from a State or
Tribe, it will deny any license applications from individuals located
in the applicable State or Tribal territory. If USDA disapproves a
State or Tribal hemp production plan, individual producers located in
the State or Tribal territory may apply for a USDA hemp production
license, unless hemp production is illegal in the State or Tribal
territory where they intend to produce hemp.
Comments to the IFR described confusion around the application
window for when USDA would receive and process applications as
described in the IFR. The IFR said that for the first year after USDA
began to accept applications, applications could be submitted any time.
For all subsequent years, license applications and license renewal
applications would have to be submitted between August 1 and October
31. AMS requested input on this application window, and commenters were
generally opposed. Under this final rule, USDA will accept applications
for USDA hemp production licenses on a rolling basis to better
accommodate the needs of producers. AMS continues to encourage the
submission of applications well before the planting season so AMS has
adequate time to process the applications. All applications must comply
with the requirements as described below. The license application is
available online at the USDA Domestic Hemp Production Program website
at https://www.ams.usda.gov/rules-regulations/hemp/information-producers. Applications may be submitted electronically or by mail.
The producer license application requires contact information such
as name, address, telephone number, and email address (if available).
If the applicant represents a business entity, and that entity will be
the producer, the application will require the full name of the
business, address of the principal business location, full name and
title of the key participants on behalf of the entity, an email address
if available, and EIN of the business entity. All applications must be
accompanied by a completed criminal history report. Several comments to
the IFR expressed opposition to this requirement. AMS is retaining this
requirement since verification of compliance with the felony
restriction is a statutory requirement. If the application is for a
business entity, a completed criminal history report must be provided
for each key participant.
Some commenters expressed concern with the requirements pertaining
to ``key participants,'' particularly with the requirement that all key
participants undergo a background check. To the extent the commenters
equated a criminal history check with a background check, AMS is
retaining this requirement, since key participants are those
individuals responsible for ensuring compliance with the regulatory
requirements contained herein. If key participants are not subject to
criminal history checks, AMS cannot ensure statutory restrictions on
individuals with felony convictions related to controlled substances
are met per Section 297B(e)(3)(B)(i) of the AMA. AMS notes that it will
not conduct any other checks into the background of key participants.
Key participants are 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 a
person in a corporate entity at executive levels including the chief
executive officer, chief operating officer, and chief financial
officer. This does not
[[Page 5609]]
include other management positions like farm, field, or shift managers.
The final rule also specifies that the definition of key participant
does not include a member of the leadership of a Tribal government who
is acting in their capacity as a Tribal leader, except when that member
exercises executive managerial control over hemp production. AMS added
this specification to address concerns raised by Indian Tribes
regarding issues that can arise when a Tribal leader is also involved
in the production of hemp in their capacity as a Tribal leader. While
AMS understands the issues that can arise when a Tribal leader is
subject to the felony conviction restriction, AMS must also ensure that
all required entities operating under a USDA plan comply with Section
297B(e)(3)(B) of the AMA. Therefore, the definition of key participants
still encompasses Tribal leaders who exercise executive managerial
control over hemp production.
USDA will not accept criminal history reports completed more than
60 days before the submission of an application, because the 60-day
window provides USDA with an expectation that the findings of the
report are reasonably current and accurate.
The criminal history report must indicate the applicant has not
been convicted of a State or Federal felony related to a controlled
substance for the 10 years prior to the date of when the report was
completed. An exception applies to a person who was lawfully growing
hemp under the 2014 Farm Bill before December 20, 2018, and whose
conviction also occurred before that date.
In addition to providing the information specified, the application
will also require license applicants to certify they will adhere to the
provisions of the plan.
Once all the necessary information has been provided, applications
will be reviewed by USDA for completeness and to determine an
applicant's eligibility. USDA will approve or deny license applications
unless the applicant is intending to produce hemp in a jurisdiction
that has submitted a plan to USDA or has a plan approved by USDA, in
which case the application for a USDA license will be denied.
Applicants will be notified if they have been granted or denied a
license either by mail or email.
If an application is denied, the applicant will receive a
notification letter or email specifying why the application was denied.
If an application is denied because it is incomplete, the applicant
will have the option of resubmitting a revised application. If the
application was denied for other reasons, the applicant will have the
opportunity to appeal USDA's decision in accordance with the appeals
process outlined in the regulation in subpart D.
Once a license application has been approved, USDA will issue the
producer license. Licenses are not transferrable in any manner. An
applicant whose application has been approved will not be considered a
licensed producer under the USDA plan until the applicant receives
their producer license. Licenses do not renew automatically and must be
renewed every three years.
Applications for renewal will be subject to the same terms and
approved under the same criteria as initial applications unless there
has been an intervening change in the applicable law or regulations
since approval of the initial or last application. In such a case, the
subsequently enacted law or regulation shall govern renewal of the
license. Licenses will be valid until December 31 of the year that is
at least three years after the license is issued. This date is not tied
to the harvest and planting season. For example, if a producer applies
for a license on August 1, 2021, and is granted a license on September
15, 2021, the license would expire December 31, 2024. A December 31
expiration date will allow licensed producers time to apply for a
license renewal prior to their prior license's expiration and prevent a
gap in licensing.
A producer licensed by USDA must report their hemp crop acreage to
FSA. Producers must provide specific information to FSA, including, but
not limited to, USDA license number, the specific location where hemp
is produced and the acreage, greenhouse, building, or site where hemp
is produced. The specific location where hemp is produced must be
identified, to the extent practicable, by the geospatial location. FSA
will provide assistance in identifying the hemp growing location.
Please refer to the Section II of this document on State and Tribal
hemp production program requirements for further discussion on FSA
reporting requirements.
If at any time there is a change to the information submitted in
the license application, a license modification is required. A license
modification is required if, for example, the licensed business is sold
to a new owner or hemp will be produced in a new location not described
on the original application. Producers must notify USDA immediately
should there be any change in the information provided on the license
application.
B. Sampling for THC
The IFR stated that all hemp production must be sampled and tested
for THC concentration levels. It is the responsibility of the licensed
producer to pay any fees associated with sampling. AMS issued guidance
on sampling procedures that meet the sampling requirements to coincide
with publication of the IFR and will update the guidance with this
final rule. AMS is requiring that all samples tested for THC
concentration levels be conducted in DEA-registered laboratories.
However, this requirement will not be applicable until December 31,
2022.
Significant input was received on the IFR sampling requirements.
Please refer to section B under State and Tribal plans above and the
discussion of comments below for a summary of findings. Producers under
the USDA plan are subject to the sampling and testing requirements as
outlined in the USDA guidelines for sampling and testing. Since USDA
cannot develop a one size fits all performance-based sampling program,
all producers licensed under the USDA plan must comply with the USDA
sampling guidelines. USDA licensed producers are responsible for
obtaining the services of sampling agents and hemp testing laboratories
themselves. USDA is updating guidance on sampling procedures and
training for sampling agents with this rule. USDA does not provide
sampling or testing services and will not pay for those services.
State and Tribal hemp regulators have successfully developed
sampling requirements that ensure adherence to State and Federal
regulations, while allowing for flexibilities due to limited State
resources and State and Tribal differences. They explained that, since
most hemp in a given region is harvested at the same time, sampling
must be completed within a very short time frame by only a few
individuals. Several States also explained that perceived risk
determines State requirements. Some States utilize different sampling
requirements for broad end-use categories like ``fiber/grain'' hemp
versus ``cannabinoid'' hemp, while others base their requirements on
historical THC concentrations of certain varietals or on the
characteristics and growing history of a certain farm or producer. AMS
agrees that sampling requirements should allow States and Indian Tribes
more flexibility in the management of their hemp regulatory programs.
[[Page 5610]]
AMS agrees that requiring sampling from every lot may be burdensome
and expensive for State and Tribal regulatory entities and producers.
AMS finds that it makes sense to allow States and Indian Tribes to
consider performance-based alternatives when developing sampling plans
that take into account unique sampling protocols for hemp growing
facilities under their jurisdiction. The sampling requirements for
State and Tribal plans allow for States and Indian Tribes to develop
unique sampling protocols for hemp growing facilities under their
jurisdiction. Sampling protocols must be sufficient at a confidence
level of 95 percent that no more than one percent of the plants in each
lot would exceed the acceptable hemp THC level and ensure that a
representative sample is collected that represents a homogeneous
composition of the lot. Alternatively, States and Indian Tribes may
adopt a performance-based sampling protocol. A performance-based
protocol must have the potential to ensure, at a confidence level of 95
percent, that the cannabis plants will not test above the acceptable
hemp THC level. USDA encourages that the alternative protocol consider
seed certification processes or process that identifies varieties that
have consistently demonstrated to result in compliant hemp plants in
that State or territory of the Indian Tribe, whether the producer is
conducting research on hemp at an institution of higher learning or
that is funded by a Federal, State, or Tribal government, whether a
producer has consistently produced compliant hemp plants over an
extended period of time, and other similar factors. AMS believes this
will provide needed flexibility to States and Indian Tribes to develop
logical and enforceable sampling requirements that take into
consideration their unique circumstances. AMS will still require States
and Indian Tribes to submit their individual sampling requirements for
review as a component of the plan approval process. If a State or
Tribal plan lacks a sampling protocol, every lot, and thereby every
producer must be sampled and tested.
When evaluating sampling protocols submitted by States and Indian
Tribes, USDA will evaluate the risk of producing non-compliant material
to determine approval or disapproval. In evaluating the risk, USDA will
take into consideration whether the performance-based factors the State
or Tribe used have the potential to ensure compliance at a 95 percent
confidence level.
Since USDA cannot develop performance metrics that would be
applicable independently from where the producer is located, producers
licensed under the USDA plan are subject to the sampling requirements
in the rule. USDA guidelines provided on the USDA website at https://www.ams.usda.gov/rules-regulations/hemp/information-sampling describe
best practices for complying with those requirements. However, USDA
would consider a performance-based sampling scheme for producers under
the USDA plan, and amend the sampling requirements accordingly, if
information collected by USDA in the future is sufficient to make this
determination. Data must be reliable and able to be applicable across
the production areas in the U.S.
Samples must be collected by a USDA-approved sampling agent, or a
Federal, State, Tribal, or local law enforcement agent authorized by
USDA to collect samples. As explained above, USDA is expanding the
training requirements for sampling agents and will provide a list of
authorized sampling agents on the USDA website. It is the
responsibility of the licensed producer to pay any fees associated with
sampling and testing. Sampling and testing guideline documents are
being updated as part of this proceeding and are available on the USDA
website.
The sampling procedures are designed to produce a representative
sample for testing. They describe procedures for entering a growing
area and collecting the minimum number of plant specimens necessary to
accurately represent the THC content, through laboratory testing, of
the sample to be tested.
C. Testing Laboratories
The THC level in representative samples must be at or below the
acceptable hemp THC level. Testing must be conducted using post-
decarboxylation or other similarly reliable methods where the total THC
concentration level measured includes the potential to convert THCA
into THC. Further, test results should be determined and reported on a
dry weight basis, meaning the percentage of THC, by weight, in a
cannabis sample, after excluding moisture from the sample. The moisture
content is expressed as the ratio of the amount of moisture in the
sample to the amount of dry solid in the sample.
Based on AMS's review of scientific studies, internal research and
information gathered from the United Nations Office on Drugs and Crime:
``Recommended Methods for the Identification and Analysis of Cannabis
and Cannabis Products'' (ISBN 978-92-1-148242-3), AMS has determined
that testing methodologies meeting these requirements include gas or
liquid chromatography with detection. As discussed earlier and stated
in Sec. 990.25(g), if a testing laboratory utilizes alternative
testing methods, they must be reviewed and approved by USDA to assess
their reliability, accuracy, and compliance with the requirements.
As explained earlier in this document, AMS is requiring that all
testing of samples for THC concentration levels be conducted in DEA-
registered laboratories. Enforcement of this requirement has been
delayed until December 31, 2022. Non-DEA-registered labs can continue
testing hemp for THC concentration until that time. Labs testing hemp
for THC must meet standards of performance described in this
regulation. Standards of performance ensure the validity and
reliability of test results; that analytical method selection,
validation, and verification are appropriate (fit for purpose); and
that the laboratory can successfully perform the testing. Furthermore,
the standards ensure consistent, accurate, analytical performance and
that the analytical tests performed are sufficiently sensitive for the
purposes of the detectability requirements under this final rule.
Laboratories conducting THC testing must also be registered with
DEA to handle controlled substances under the CSA (21 U.S.C. 822 and 21
U.S.C. 844) and DEA regulations (21 CFR part 1301). USDA is adopting
this requirement because of the potential for these laboratories to
handle cannabis products testing above 0.3 percent THC. Such products
are, by definition, marijuana, and a controlled substance. DEA
registration requirements verify a laboratory's ability to properly
handle controlled substances.
As previously explained in the requirements for State and Tribal
plans, AMS is not adopting requirements that hemp testing laboratories
be approved under a USDA Laboratory Approval Program or undergo ISO
accreditation.
It is the responsibility of the licensed producer to select the
DEA-registered laboratory that will conduct the testing and to pay any
fees associated with testing. Laboratories performing THC testing for
hemp produced under this program are required to share test results
with the licensed producer and USDA. USDA will provide instructions to
all approved labs on how to electronically submit test results to USDA.
Laboratories may provide test results to licensed producers in whatever
manner best aligns with their business practices, but producers must
[[Page 5611]]
be able to produce a copy of test results. For this reason, providing
test results to producers through a web portal or through electronic
mail, so the producer will have ready access to print the results when
needed, is preferred.
Samples exceeding the acceptable hemp THC level are marijuana and
will be handled in accordance with the procedures discussed in section
C below.
Any licensee may request that the laboratory retest pre-harvest
samples, if it is believed the original THC concentration level test
results were in error. The licensee requesting the retest of the second
sample would pay the cost of the test. The retest results would be
issued to the licensee requesting the retest, and a copy would be
provided to USDA or its agent.
Research Institutions Sampling and Testing
AMS also acknowledges that research institutions face special
circumstances when conducting hemp research. Under the IFR, researchers
and research institutions were required to comply with the same
production requirements as commercial producers. Under this final rule,
and as described in detail below, research institutions and the
producers working with them are afforded greater sampling and testing
flexibility to facilitate continued hemp research. Producers that
produce hemp for research must obtain a USDA license. However, the hemp
that is produced for research is not subject to the same sampling
requirements provided that the producer adopts and carries out an
alternative sampling method that has the potential to ensure, at a
confidence level of 95 percent, that the cannabis plant species
Cannabis sativa L. that will be subject to this alternative method will
not test above the acceptable hemp THC level. The rule includes a
performance-based standard for sampling for all licensed producers in
section 990.24: ``at a confidence level of 95 percent that no more than
one percent (1%) of the plants in the lot would exceed the acceptable
hemp THC level.'' The performance-based standard for research is a
modification of that standard: ``the potential to ensure, at a
confidence level of 95 percent, that the cannabis plant species
Cannabis sativa L. that will be subject to this alternative method will
not test above the acceptable hemp THC level.'' We are comfortable with
this modification to recognize that researchers may need flexibility to
conduct their research and because the research hemp cannot enter the
stream of commerce. USDA will monitor researchers' compliance with this
standard as part of its normal oversight and compliance program.
USDA licensees shall ensure the disposal of all non-compliant
plants. USDA licensees shall also comply with the reporting
requirements including reporting disposal of non-compliant plants.
Research institutions that handle ``hot'' hemp must follow CSA
requirements for handling marijuana.
Performance based plans from research institutions where a State or
Tribal plan is not in place will be reviewed by USDA. Notice and
comment requirements under the PRA process will be followed before a
final determination is made by USDA to move forward with approving
performance-based plans for those producers under the USDA plan.
States and Indian Tribes are allowed to develop performance-based
requirements for these institutions. However, the alternative method
must have the potential to ensure, at a confidence level of 95 percent,
that the cannabis plant species Cannabis sativa L. that will be subject
to the alternative method will not test above the acceptable hemp THC
level.
The research institutions must follow reporting requirements. AMS
believes this exception is necessary to help support research and
development as it relates to hemp production. This decision allows
these types of research facilities and institutions to confidently
oversee the study of hemp plants through trialing and genetics
research. AMS believes this exception to be critical to the growth of
industry, particularly in its infancy. Over time, the exception
provided by this final rule will help to stabilize the industry by
providing greater understanding of hemp genetics and how certain
varietals respond differently to growing conditions in various
geographic locations. All producers are expected to benefit from such
knowledge as they will be made aware of the more stable and
consistently reliable hemp varietals. Any non-compliant plants produced
by research institutions as a result of research and development will
still need to be disposed and verified through documentation. Research
institutions must follow licensing and reporting requirements.
D. Disposal of Non-Compliant Product
Under the IFR, non-compliant product was required to be disposed of
by persons authorized to do so under the CSA and had to be destroyed.
As explained below, under this final rule, producers may handle non-
compliant product disposal on the farm, and they have greater
flexibility in remediating that product. USDA producers are required to
follow procedures for ensuring effective disposal of cannabis plants
produced in violation of this rule. Plants that are removed as a result
of poor plant health, pests, disease, weather events, along with
removal of male or hermaphrodite plants as part of a cross-pollination
prevention plans, are not subject to the disposal requirements herein.
This final rule retains the disposal requirements explained in the IFR,
but clarifies what ``disposal'' means and explains how the process must
be conducted. If a producer grew cannabis exceeding the acceptable hemp
THC level, the IFR required that the material be disposed of in
accordance with the CSA and DEA regulations because such material is
marijuana, a Schedule I controlled substance under the CSA. The IFR
required that material be collected for disposal by a person authorized
under the CSA to handle marijuana, such as a DEA-registered reverse
distributor, or a duly authorized Federal, State, Tribal, or local law
enforcement officer.
As explained earlier, AMS is now allowing the flexibility to
conduct on-farm disposals and also allowing for remediation options.
If the results of a test conclude that the THC levels exceed the
acceptable hemp THC level, the laboratory will promptly notify the
producer and USDA or its authorized agent. If a licensed producer is
notified that they have produced cannabis exceeding the acceptable hemp
THC level, the cannabis must be disposed of in accordance with the on-
farm disposal options described herein.
Licensed producers notified they have produced cannabis plants
exceeding the acceptable hemp THC level must arrange for disposal or
remediation of the lot represented by the sample in accordance with the
procedures as specified above and described on the USDA website at
https://www.ams.usda.gov/rules-regulations/hemp/disposal-activities.
Producers must document the disposal or remediation of all non-
compliant cannabis. This can be accomplished by providing USDA with a
copy of the documentation of disposal or remediation using the
reporting requirements established by USDA. These reports must be
submitted to USDA following the completion of the disposal or
remediation process.
E. Compliance
As described below, this final rule changes the THC threshold for a
negligent violation from 0.5 percent
[[Page 5612]]
under the IFR to 1.0 percent. Further, rather than being liable for
multiple negligent violations in each growing season as under the IFR,
this final rule provides that producers can only incur one negligent
violation in each growing season, which prevents producers from
accumulating multiple negligent violations and losing program
eligibility after a single growing season.
USDA will maintain oversight of USDA-licensed hemp producers by
conducting audits of USDA licensees and working with licensees with
negligent violations to establish corrective action plans. Negligent
violations by a producer may lead to suspension or revocation of a
producer's license.
While USDA has not yet conducted any random audits, the department
may conduct random audits of licensees to verify hemp is being produced
in accordance with Subtitle G of the AMA no more frequently than every
three years, based on available resources. The format of the audit will
vary and may include a ``desk-audit'' where USDA requests records from
a licensee, or the audit may be a physical visit to a licensee's
facility. When USDA visits a licensee's facility, the licensee must
provide access to any fields, greenhouses, storage facilities, or other
locations where the licensee produces hemp. USDA may also request
records from the licensee, to include production and planting data,
testing results, and other information as determined by USDA.
USDA will issue a summary of the audit to the licensee after the
completed audit. Licensees who are found to have a negligent violation
will be subject to a corrective action plan. Negligent violations
include: (1) Failure to provide a legal description of the land on
which the hemp is produced; (2) not obtaining a license before engaging
in production; or (3) producing plants exceeding the acceptable hemp
THC level. Similar to the requirements for State and Tribal plans, USDA
will not consider hemp producers as committing a negligent violation if
they produce plants exceeding the acceptable hemp THC level if they use
reasonable efforts to grow hemp and the cannabis plant does not have a
THC concentration of more than 1.0 percent on a dry weight basis. AMS
believes that increasing the negligence threshold from 0.5 percent to
1.0 percent will increase flexibility to farmers as they learn more
about how to grow compliant hemp and as the availability of stable hemp
genetics improves. Further, producers may only receive one negligent
violation per growing season, as determined by USDA based on a review
of producer records. USDA will use a calendar year as a growing season.
When USDA determines that a negligent violation has occurred, USDA
will issue a Notice of Violation. This Notice of Violation will include
a corrective action plan. The corrective action plan will include a
reasonable date by which the producer will correct the negligent
violation or violations and will require the producer to periodically
report to USDA on its compliance with the plan for a period of not less
than the next two calendar years. A producer who has negligently
violated the provisions of this rule three times in a five-year period
is ineligible to produce hemp for a period of five years from the date
of the third violation. Negligent violations are not subject to
criminal enforcement.
Hemp found to be produced in violation of this regulation, such as
hemp produced on a property not disclosed by the licensed producer or
without a license, would be subject to the same disposal provisions as
for cannabis testing above the acceptable hemp THC level. Further, if
it is determined a violation was committed with a culpable mental state
greater than negligence, USDA will report the violation to law
enforcement.
The 2018 Farm Bill limited the participation of certain convicted
felons in hemp production. A person with a State or Federal felony
conviction relating to a controlled substance is subject to a 10-year
ineligibility restriction on producing hemp under the Act. An exception
applies to a person who was lawfully growing hemp under the 2014 Farm
Bill before December 20, 2018, and whose conviction also occurred
before that date.
F. Suspension of a USDA License
There are no changes to the IFR provisions related to suspension of
USDA licenses in this final rule.
A USDA license may be suspended if USDA receives credible
information that a USDA licensee has either: (1) Engaged in conduct
violating a provision of this regulation; or (2) failed to comply with
a written order from the AMS Administrator related to a negligent
violation of this regulation. Examples of credible information are
information from local authorities of harvested plants without testing
or planting of hemp in non-licensed locations.
Any person whose license has been suspended shall not produce hemp
during the period of suspension. A suspended license may be restored
after a waiting period of one year. A producer whose license has been
suspended may be required to comply with a corrective action plan to
fully restore their license.
A USDA license shall be immediately revoked if the USDA licensee:
(1) Pleads guilty to, or is convicted of, any felony related to a
controlled substance; \9\ (2) made any materially false statement with
regard to this regulation to USDA or its representatives with a
culpable mental state greater than negligence; or (3) was found to be
growing cannabis exceeding the acceptable hemp THC level with a
culpable mental state greater than negligence or negligently violated
the provisions of this regulation three times in five years.
---------------------------------------------------------------------------
\9\ For a corporation, if a key participant has a disqualifying
felony conviction, the corporation may remove that person from a key
participant position. Failure to remove that person will result in a
license revocation.
---------------------------------------------------------------------------
If the licensed producer wants to appeal any suspension or
revocation decision made by USDA as described in this section, they can
do so using the appeal process explained in section V of this document.
G. Reporting and Recordkeeping
The 2018 Farm Bill requires USDA to develop a process to maintain
relevant information regarding the land where hemp is produced.
Reporting requirements under this final rule, particularly the
requirement to report hemp crop acreage to FSA, are discussed
extensively in Section B of the State and Tribal plan requirements and
the same requirements are applicable to USDA licensed producers.
In general, changes from the IFR allow producers more flexibility
in defining for FSA the areas (instead of ``lots'') they use for hemp
production. USDA hemp production licensees can apply for licenses on a
rolling basis under this final rule, in contrast to the limited period
provided under the IFR. Reporting requirements under this final rule
are revised slightly to allow producers to account for on-farm disposal
of non-compliant product.
USDA's FSA is well suited to collect this information for the
domestic hemp production program. FSA has staff throughout the United
States who are trained to work with farmers to verify land uses. Many
hemp producers are likely to be familiar with the FSA since they
already operate traditional farms, and therefore already provide data
to FSA on acres and crops planted. Producers may benefit from
information to participate in other USDA programs through FSA offices.
Licensed producers will be required to report their hemp crop acreage
with FSA, and to provide FSA with specific
[[Page 5613]]
information regarding field acreage, greenhouse, or indoor square
footage of hemp planted. This information must include street address,
geospatial location or other comparable identification method
specifying where the hemp will be produced, and the legal description
of the land. Geospatial location or other methods of identifying the
production locations are necessary, as not all rural locations have
specific addresses. This information is required for each field,
greenhouse, building, or site where hemp will be grown. USDA will use
this information to assemble and maintain the data USDA must make
available in real time to Federal, State, Tribal and local law
enforcement as required by the 2018 Farm Bill and as described in
section G below.
Specific procedures for reporting hemp acreage to FSA will be
posted on the USDA Domestic Hemp Production Program website. All
information will be maintained by USDA for at least three calendar
years. FSA will assist producers in identifying the hemp growing
locations since they have maps that allow for better identification.
This is a procedure that FSA employees are very familiar with since it
is used for other USDA programs. This rule also revises the definition
of ``lot'' to include other terms used by FSA with the same meaning.
FSA uses terms like ``farm,'' ``tract,'' ``field,'' and ``subfield.''
FSA staff will not provide a ``lot number'' to producers as described
in the IFR. Instead, FSA will assist producers to identify the area
where hemp is grown. More details are provided under the States and
Tribal plan Section B earlier in this final rule.
Licensed producers are required to maintain copies of all records
and reports necessary to demonstrate compliance with the program. These
records include those that support, document, or verify the information
provided in the forms submitted to USDA. Records and reports must be
kept for a minimum of three years. Because the final rule allows
producers to remediate plants, the final rule also requires producers
to maintain records on all remediated cannabis plants.
Under the USDA plan, there will be additional reporting
requirements for licensed producers. These include information
requested in the application for a license and the record and reporting
requirements needed to document disposal or remediation of cannabis
produced in violation of the provisions of this rule. Specific
reporting requirements are detailed in Sec. 990.71.
H. Information Sharing With Law Enforcement
USDA is working to develop and maintain a database of all relevant
and required information regarding hemp as specified by the 2018 Farm
Bill. This database will be accessible in real time to Federal, State,
local, and Tribal law enforcement officers through a Federal government
law enforcement system. USDA AMS will administer and populate this
database, which will include information submitted by States, Tribes,
laboratories, and USDA licensed producers and information submitted to
FSA. States and Tribes must provide information to USDA in a format
that is compatible with USDA's information sharing system. USDA will
work with States and Indian Tribes on system format and other
information necessary to share information.
USDA will use this information to create a comprehensive list of
all domestic hemp producers. USDA will also gather the information
related to the land used to produce domestic hemp. This information
will be comprehensive and include data from both State and Tribal plans
and will include a legal description of the land on which hemp is grown
by each hemp producer and the corresponding geospatial location or
other identifiable location. Finally, USDA will also gather information
regarding the status of all licenses issued under State and Tribal
government plans and under the USDA plan.
This information will be made available in real time to Federal,
State, local and Tribal law enforcement as required by the 2018 Farm
Bill.
IV. Definitions
The following terms are integral to implementing Subtitle G of the
AMA and establish the scope and applicability of the regulations of
this final rule.
The term ``Act'' refers to the Agricultural Marketing Act of 1946.
The 2018 Farm Bill amended the Agricultural Marketing Act of 1946 by
adding Subtitle G, which is a new authority for the Secretary of
Agriculture to administer a national hemp production program. Section
297D of Subtitle G authorizes and directs USDA to promulgate
regulations to implement this program.
The ``Agricultural Marketing Service'' or ``AMS'' is the
Agricultural Marketing Service of the U.S. Department of Agriculture is
the agency the Secretary of Agriculture has been charged with the
responsibility to oversee the administration of this new program.
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'' 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 are regulated. Because cannabis with
THC content concentration levels of higher than 0.3 percent is deemed
to be marijuana, a Schedule I controlled substance, its regulation
falls under 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 final
rule.
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 conducting criminal history record searches determine
disqualifying crimes.
A ``corrective action plan'' is a plan agreed to by a State, Tribal
government, or USDA for a licensed hemp producer, to correct a
negligent violation or non-compliance with a hemp production plan, its
terms, the applicable law(s) or this regulation. Corrective action
plans may also be a plan set forth by a State or Tribal government with
an approved
[[Page 5614]]
hemp production plan to correct a non-compliance of their program with
their USDA-approved plan. This term is defined in accordance with the
2018 Farm Bill, which mandates certain non-compliant 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 consequences. 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 THCA into delta-9 THC, the intoxicating
component of cannabis. The decarboxylated value is also calculated
using a molecular mass conversion ratio that sums delta-9 THC and
eighty-seven and seven tenths (87.7) percent of THC-acid ((delta-9 THC)
+ (0.877*THCA)).
``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.
The term ``disposal'' means the action or process of getting rid of
cannabis that is non-compliant.
``DEA'' is an acronym for the ``Drug Enforcement Administration,''
a United States Federal law enforcement agency under the United States
Department of Justice. The DEA is the lead agency for domestic
enforcement of the Controlled Substances Act. The DEA plays an
important role in the oversight of the disposal of marijuana, a
Schedule I controlled substance, under the regulations of this part.
The DEA is also instrumental in registering laboratories to legally
handle controlled substances, including cannabis samples that test
above the 0.3 THC concentration level.
``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 of 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, the term ``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.
The 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.
``Liquid chromatography (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, LC 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.
``Indian Tribe or Tribe'' is defined in the 2018 Farm Bill by
reference to section 4 of the Indian Self-Determination and Education
Assistance Act (25 U.S.C. 5304). The statutory definition is self-
explanatory, and USDA is adopting the same definition without change
for part 990.
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, including tribally-owned corporation
individuals, at executive levels, including chief executive officer,
chief operating officer, and chief financial officer. This does not
include such management personnel as farm, field, or shift managers.
This definition also does not include a member of the leadership of a
Tribal government who is acting in their capacity as a Tribal leader
except when that member exercises executive managerial control over
hemp production.
``Law enforcement agency'' refers to all Federal, State, Tribal, or
local law enforcement agencies. Under the 2018 Farm Bill, State and
Tribal 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
greater than negligence.'' To assist law enforcement in the fulfillment
of these duties, the 2018 Farm Bill also mandates information sharing
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 FSA. For FSA reporting purposes, FSA staff will
determine the appropriate designation for the specific location(s)
where hemp is being grown using FSA terminology such as ``farm,''
``tract,'' ``field,'' and ``subfield'' to mean ``lot'' for the purpose
of this rule.
``Marijuana,'' or, as defined in the CSA, ``marihuana,'' 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
[[Page 5615]]
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 THC concentration level
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 rule, 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 final rule.
Used in relation to the other terms and regulations in this part,
``phytocannabinoids'' are cannabinoid chemical compounds found in the
cannabis plant, two of which are Delta-9 tetrahydrocannabinol (delta-9
THC) and cannabidiol (CBD). Testing methodologies under this part will
refer to the presence of ``phytocannabinoids'' as either THC or CBD.
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.
The 2018 Farm Bill mandates that all cannabis be tested for THC
concentration levels using ``post-decarboxylation'' or similar methods.
In the context of this part, ``post-decarboxylation'' 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 post-decarboxylation 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 post-
decarboxylation value of THC, or total THC, can also be calculated by
using a liquid chromatograph technique, which keeps the THCA intact,
and requires a conversion calculation of that THCA to calculate total
potential THC. See also the definitions for decarboxylation and total
THC.
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.
``Producer'' means a producer as defined in 7 CFR 718.2
specifically of hemp. The 2018 Farm Bill mandates that USDA maintain a
real-time informational database that identifies registered hemp
production sites, whether under a State, Tribal, or USDA plan, for the
purposes of compliance and tracking with law enforcement. AMS will
maintain this system with the information collection assistance of FSA.
In order to maintain consistency and uniformity of hemp production
locations, USDA is using FSA to collect this information through their
crop acreage reporting system. In this context, a common use of the
term ``producer'' is essential to maintaining a substantive database.
For this reason, the definition of ``producer'' incorporates the FSA
definition of ``producer'' with the additional qualifier that they are
a producer specifically of hemp. All producers are required to be
licensed or authorized to produce hemp under the USDA Domestic Hemp
Production Program.
``Remediation'' refers to techniques utilized to transform non-
compliant cannabis into something useful and compliant while disposing
of non-compliant parts. Remediation can occur by removing and
destroying flower material, while retaining stalk, stems, leaf
material, and seeds. Remediation can also occur by shredding the entire
plant into a bio-mass like material, then re-testing the shredded
biomass material for compliance.
``Secretary'' means the Secretary of Agriculture of the United
States Department of Agriculture.
Section 297A of the Act defines ``State'' as 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 ``State department of agriculture'' is defined by the 2018
Farm Bill as the agency, commission, or department of a State
government responsible for agriculture in the State. The statutory
definition is self-explanatory, and USDA is adopting the same
definition without change for part 990.
The term ``store'' is related to 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.
The term ``Territory of the Indian Tribe'' means (a) all land
within the limits of any Indian reservation under the jurisdiction of
the United States Government, notwithstanding the issuance of any
patent, including rights-of-way running through the reservation, (b)
all dependent Indian communities within the borders of the United
States whether within the original or subsequently acquired territory
thereof, and whether within or without the limits of a State; (c) all
Indian allotments, the Indian titles to which have not been
extinguished, including rights-of-way running through the same; and (d)
any lands title to which is either held in trust by the United States
for the benefit of any Indian Tribe or individual or held by any Indian
Tribe or individual subject to restriction by the United States against
alienation and over which an Indian Tribe exercises jurisdiction.
The IFR defined the Territory of the Indian Tribe as ``Indian
Country'' in 18 U.S.C. 1151 because section 1151 is a commonly
acceptable approach to determine a Tribal government's jurisdiction.
The final rule retains the language of section 1151, but adds item (d)
to the definition of ``Territory of the Indian Tribe.'' This addition
does not significantly expand the definition because many of the lands
encompassed by item (d) were already considered as ``Territory of the
Indian Tribe'' under the IFR. For example, off-reservation trust land,
if not considered part of a reservation under section 1151(a), is
generally considered within a dependent Indian community under section
1151(b). See Club One Casino, Inc. v. Bernhardt, 959 F.3d 1142, 1149-50
(9th Cir. 2020); Felix Cohen, Cohen's Handbook of Federal Indian Law,
section 3.04 (Nell Jessup Newton ed. 2012). Also, restricted fee lands
outside of a reservation are often considered part of a dependent
Indian community, provided the lands satisfy the two requirements of a
dependent Indian community--lands that are (1) set aside by the Federal
Government for the use of the Indians and (2) under federal
superintendence. Citizens Against Casino Gambling in Erie Cty. v.
Chaudhuri, 802 F.3d 267, 281 (2d Cir. 2015).
[[Page 5616]]
However, because ``dependent Indian communities'' is an oft-
litigated term that is interpreted varyingly amongst the courts, USDA
decided to add item (d) to the definition of ``Territory of the Indian
Tribe'' to add clarity and ensure nationwide consistency regarding the
jurisdictional boundaries of regulatory authority over the production
of hemp.
``Total THC'' is the post-decarboxylation value of THC, either
after testing with gas chromatography or LC after using a conversion
factor. LC does not use decarboxylation as part of the process and this
addition is to account for the conversion of THCA into THC if
decarboxylation was part of the process. The addition of 87.7 percent
of THCA is applicable if the testing laboratory uses LC with detection
to measure the THC. Total THC is the measured THC plus 87.7 percent of
THCA.
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.
``USDA'' is an acronym that stands for the ``United States
Department of Agriculture.''
V. Appeals
The following paragraphs explain when and how to appeal a USDA
decision. State or Tribal plans may include similar appeal procedures.
No changes were made to this section based on comments.
An applicant for a USDA hemp production program license may appeal
a license denial to the AMS Administrator. USDA licensees can appeal
denials of license renewals, license suspensions, or license
revocations to the AMS Administrator. All appeals must be submitted in
writing and received within 30 days of the denial. Appeals may be
submitted by mail or electronic form. This submission deadline should
provide adequate time to prepare the necessary information required for
the appeal. The Administrator will take into account the applicant or
USDA licensee's justification for why the license should not be denied,
suspended, or revoked, and then issue a final determination.
Determinations made by the Administrator under the appeals process will
be final unless the applicant or USDA licensee requests a formal
adjudicatory proceeding to review the decision, which will be conducted
pursuant to the U.S. Department of Agriculture's Rules of Practice
Governing Formal Adjudicatory Proceedings, 7 CFR part 1, subpart H,
which USDA will amend to add the Domestic Hemp Production Program. If
the applicant or USDA licensee does not request that the Administrator
initiate a formal adjudicatory proceeding within 30 days of the
Administrator's adverse ruling, such ruling becomes final.
Appeals Under a State or Tribal Hemp Production Plan
A State or Tribe can appeal the denial of a proposed hemp
production plan, or the proposed suspension or revocation of a plan by
USDA. USDA will consult with States and Tribes to help ensure their
draft plans meet statutory requirements, and that existing plan
requirements are monitored and enforced by States and Indian Tribes.
If, however, a proposed State or Tribal plan is not approved, or an
existing plan is suspended or revoked the decision may be appealed.
If the AMS Administrator grants a State or Indian Tribe's appeal of
a disapproval of its hemp plan, the proposed State or Tribal hemp
production plan shall be approved as proposed. If the AMS Administrator
denies an appeal, prospective producers located in the State or Tribal
Territory can apply directly to USDA for a hemp license. Similarly, if
an appeal of a denied proposed State or Tribal plan is denied,
producers located in the impacted State or Tribal territory may apply
for licenses under the USDA plan.
A State or Tribe appealing the suspension or revocation of their
hemp production plan must explain the reasoning for the appeal and the
appeal must be filed within the time-period provided in the letter of
notification or within 30 business days from receipt of the
notification, whichever occurs later. This timeframe should be adequate
for the assembly of the information required to be submitted as part of
the appeal.
VI. Interstate Commerce
Nothing in this rule prohibits the interstate commerce of hemp. No
State or Indian Tribe may prohibit the transportation or shipment of
hemp produced in accordance with this part and with section 7606 of the
2014 Farm Bill (expires January 1, 2022) through the State or the
territory of the Indian Tribe, as applicable.\10\
---------------------------------------------------------------------------
\10\ See section 10114 of the 2018 Farm Bill and the USDA
General Counsel's Legal Opinion on the Authorities for Hemp
Production at https://www.ams.usda.gov/content/legal-opinion-authorities-hemp-production.
---------------------------------------------------------------------------
VII. Outreach
As part of this rulemaking process, AMS held numerous meetings with
State and Tribal governments and their representatives, industry
organizations, groups and individuals with experience in the hemp
industry, and representatives of law enforcement, as well as other
Federal agencies.
In addition, USDA also conducted a listening session on March 13,
2019, that had more than 2,100 participants, and included comments from
46 separate speakers representing States, Tribes, producers, end-users,
hemp organizations, and others. The recording of the listening session
is available on the USDA website at https://www.ams.usda.gov/rules-regulations/hemp. On May 1 and 2, 2019, USDA also participated in
Tribal consultation meetings for a total of 52 and 38 participants,
respectively. On September 24, 2020, AMS conducted another Tribal
Consultation with approximately 90 participants.
AMS published an interim final rule on October 31, 2019 (84 FR
58522), that established a temporary hemp production program and
invited public comments on the program's provisions. The initial 60-day
comment period was extended by 30 days on December 18, 2019 (84 FR
69295). The comment period was reopened for another 30 days on
September 8, 2020 (85 FR 55363). A total of approximately 5,900
comments were submitted by States, Tribes, farmers, industry
associations, and other interested groups and individuals during the
combined comment periods expressing their views on the provisions of
the IFR and suggesting modifications, many of which have been
incorporated into this final rule.
Finally, in November 2019, AMS posted an informational webinar
about the domestic hemp production program on its website (in English
and Spanish) at https://www.ams.usda.gov/rules-regulations/hemp. AMS
has also posted additional useful information for regulated entities
and other interested persons on its website at https://www.ams.usda.gov/rules-regulations/hemp.
As required by the Farm Bill, the Secretary developed this final
rule and related guidelines in consultation with the U.S. Attorney
General. In addition, USDA has submitted information to, and consulted
with, the Committee on Agriculture of the House of Representatives and
the Committee on Agriculture, Nutrition, and Forestry of the Senate
regarding updates on the
[[Page 5617]]
implementation of the hemp requirements in the Farm Bill.
VIII. Severability
This final rule includes a severability provision. This provision
helps address the status of the regulations should a court vacate a
particular provision. This section provides that if any provision of
part 990 is found to be invalid, the remainder of the part shall not be
affected.
IX. Comment Analysis
AMS accepted comments during an initial comment period from October
31, 2019 through December 31, 2019. On December 18, 2019 (84 FR 69295),
this initial comment period was extended for an additional 30 days,
ending January 29, 2020. AMS reopened the comment period for 30
additional days on September 8, 2020 (85 FR 55363), ending October 8,
2020. Comments may be accessed through Regulations.gov.\11\ Reopening
the comment period gave interested persons an additional opportunity to
comment on the IFR. Comments were solicited from all stakeholders,
notably those who were subject to the regulatory requirements of the
IFR during the 2020 production cycle.
---------------------------------------------------------------------------
\11\ https://www.regulations.gov/searchResults?rpp=25&po=0&s=AMS-SC-19-0042&fp=true&ns=true..
---------------------------------------------------------------------------
AMS specifically requested comments on the 15-day sampling and
harvest timeline; the possibility of establishing a fee-for-service
hemp laboratory approval process for labs that wish to offer THC
testing services; the possibility of requiring all laboratories testing
hemp to have ISO 17025 accreditation; the number of labs already ISO
17025 accredited; additional examples of reasonable efforts to
illustrate actions hemp producers can take in order to avoid committing
a negligent violation under the program; the sufficiency of the hemp
license application period; whether the information collection for the
program is necessary for the proper performance of the functions of the
agency, including whether the information will have practical utility;
the accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; the ways to enhance the quality, utility, and
clarity of the information to be collected; the ways to minimize the
burden of the collection of information on those who are to respond,
including the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology; whether there is information or data that may inform
whether or not the market will experience a significant shift, either
positive or negative, in the developing hemp market and on consumers;
any data or information on what impacts the regulation may have on
current and future innovation in the areas of industrial hemp usages
and how much such impacts on innovation may affect rural communities;
the potential for innovation and the uncertainty and its impact on the
hemp market vis a vis steady State; and additional reliable data
sources on the annual receipts of industrial hemp producers.
AMS received approximately 5,900 comments. Comments represented the
views of States, Indian Tribes, hemp farmers and processors,
universities, laboratories, trade associations, carriers, non-profit
associations, other Federal government agencies, consumers, and other
interested individuals. A summary of the comments and AMS's analysis
and response follows.
Extention of Comment Period
Several commenters urged AMS to extend the public comment period to
allow for small businesses to meaningfully participate in this
rulemaking process. One reason given was that the comment period fell
in the middle of the harvest season for much of the mid-Atlantic and
southern hemp growers, excluding those who grow indoors, and therefore
were too busy to comment. Other reasons given were the ongoing global
pandemic as well as many other ongoing natural disasters nation-wide
that have presented additional strains and unique challenges to
agricultural operations.
AMS Response: AMS provided an initial 60-day comment period and a
30-day extension and then reopened the comment period for 30 additional
days in order to receive feedback from stakeholders thus giving ample
time to interested parties to submit comments. In order to finalize the
Domestic Hemp Promotion Program before the 2021 production cycle
begins, AMS decided not to extend the comment period and to finalize
this rule.
Extension of 2014 Pilot Program
Under the 2014 Farm Bill, State departments of agriculture and
institutions of higher education were permitted to produce hemp as part
of a pilot program for research purposes. Congress extended this
authority under the 2021 Continuing Appropriations Act until January 1,
2022. After January 1, 2022, domestic hemp production must comply with
Subtitle G of the AMA and this final rule.
Comments: Numerous comments praised the hemp production regulatory
schemes established by States and Universities under the 2014 Farm Bill
authority. Many comments reflected on the perceived increase in
regulatory burden under the IFR, as opposed to the regulatory scheme
that has been applied to domestic hemp production until now. Many
comments, while making recommendations with regards to specific aspects
of the IFR provisions, also encouraged USDA to continue to regulate
domestic hemp production under the 2014 Farm Bill until satisfactory
resolution of industry concerns can be achieved. Further, several
comments stated that the extension of the pilot programs under the 2014
Farm Bill for another two to three years would give the industry time
to adjust to the new requirements and to develop hemp genetics to more
easily comply with the regulations.
A few comments opposed extension of the 2014 Farm Bill pilot
program, asserting that States now operating under the more restrictive
2018 Farm Bill provisions are placed at a disadvantage.
AMS response: The extension of the 2014 Farm Bill authority is not
within the authority of USDA. Congress only extended this authority
under the 2021 Continuing Appropriations Act (Pub. L. 116-260), until
January 1, 2022.
THC Limit
The IFR adopts the 2018 Farm Bill definition of hemp as the plant
species Cannabis sativa L. and any part of that plant with a delta-9
tetrahydrocannabinol concentration of not more than 0.3 percent on a
dry weight basis. Further, the IFR requires that THC levels in
representative samples test at or below the acceptable hemp THC level.
Testing must be conducted using post-decarboxylation or other similarly
reliable methods, where the total THC concentration level measured
includes the potential to convert THCA into THC. Finally, the IFR
provides that hemp testing higher than the acceptable hemp THC level is
considered a controlled substance and requires disposal.
Comments: Some comments supported the 2018 Farm Bill's hemp THC
level of 0.3 percent, and some explained that States had successfully
incorporated that limit into programs authorized under the 2014 Farm
Bill. Some comments thanked USDA for clearly defining the delta-9 THC
standard in the IFR, which commenters
[[Page 5618]]
said would foster uniformity across hemp production in all States.
However, a greater number of comments from various stakeholder
groups, including producers, States, Indian Tribes, and hemp
organizations, asserted that the 0.3 percent threshold is too low and
impractical in a program intended for multiple end uses of hemp.
Comments argued that individuals interested in obtaining cannabis for
intoxication purposes are unlikely to be interested in material
containing 1.0 percent THC--or perhaps higher, and that setting the
threshold at even 1.0 percent THC would give farmers, breeders, and
researchers a lot more flexibility and confidence in producing
compliant crops. One commenter reported that their State recognizes
hemp with THC concentrations of up to 0.39 percent, with most crops
testing between 0.31 and 0.39 percent THC, and no end products testing
higher than 0.3 percent THC. The comment suggested USDA should raise
the THC limit to at least 0.39, if not up to 0.5 percent. Other
comments recommended revising the threshold to a higher level,
asserting that there is no scientific evidence that supports use of the
0.3 percent level. Some comments recommended increasing the threshold
to 0.8 or 1.0 percent, while some suggested 2.0 percent and others as
much as 5.0 percent. Comments explained that a THC concentration of 5
percent is not viable for recreational marijuana markets and that USDA
should consider the end-use potential when determining a threshold. One
comment recommending a THC threshold of at least 2.0 percent included a
news story reporting that marijuana plants confiscated by law
enforcement routinely have THC concentrations of 12 percent or
higher.\12\
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\12\ McCullough, Jolie. ``Marijuana Prosecutions in Texas Have
Dropped by More than Half Since Lawmakers Legalized Hemp.'' The
Texas Tribune, 3 January 2020; www.texastribune.org/2020/01/03/texas-marijuana-prosecution-drop-testinghemp/.
---------------------------------------------------------------------------
Several comments suggested that the IFR's level of 0.3 percent
delta-9 THC on a dry-weight basis is ``more aspirational than
practical.'' Comments explained that THC levels vary with plant
maturity and other factors. Comments urged USDA to build greater
flexibility into the rule so producers don't unwittingly become illegal
marijuana farmers as a result of factors beyond their control. One
comment suggested USDA establish a wider gap between the THC levels
that define controlled substances and agricultural commodities such as
hemp to create an environment where hemp producers are presumed
innocent until proven guilty of intentionally producing a controlled
substance. Several comments recommended that university and other
research programs be given more leeway as they work toward developing
more compliant, regionally appropriate varieties through breeding.
Some comments noted that hemp containing more than 0.3 percent THC
is not eligible for crop loss or replant payments under USDA Risk
Management Agency regulations. Comments said further that if USDA is
not certifying seed because of the regional effects of growing
conditions on genetics, farmers are at risk and should be able to
obtain comprehensive insurance coverage for crops with negligible
overage above the acceptable THC level.
Comments explained that while the genetics of most U.S. crops have
been developed over many years, hemp has not enjoyed that history, and
it will take time to develop compliant but commercially viable crops
with marketable CBD content for different regions. Comments asserted
farmers will have fewer planting options because of the lack of a
national hemp seed certification protocol and limited agronomic
research on hemp varietals and production practices. Comments inferred
that the 0.3 percent THC threshold would effectively demand that
farmers plant a nationwide monoculture with little genetic diversity,
which they said would leave U.S. hemp crops vulnerable to pests and
diseases.
Many comments questioned the selection by Congress of the 0.3
percent THC threshold to legally distinguish hemp from marijuana.\13\
Comments frequently referenced a 1976 publication, A Practical and
Natural Taxonomy for Cannabis, in which horticulturalists Dr. Ernest
Small and Arthur Cronquist used 0.3 percent THC as a threshold to
distinguish hemp from marijuana in their scientific study on
cannabis.\14\ Comments highlighted statements made by Small and
Cronquist, saying the researchers openly acknowledged that they
``arbitrarily adopt a concentration of 0.3 percent delta-9 THC (dry
weight basis) in young, vigorous leaves of relatively mature plants as
a guide to discriminating two classes of plants,'' and that the number
was never intended to define hemp from a legal perspective. According
to the comment, Small and Cronquist made no conclusionary statement on
the use of the 0.3 percent THC threshold.
---------------------------------------------------------------------------
\13\ Johnson, Renee. ``Hemp as an agricultural commodity.''
Congressional Research Service (2014).
\14\ Small, Ernest, and Arthur Cronquist. ``A practical and
natural taxonomy for Cannabis.'' Taxon (1976): 405-435.
---------------------------------------------------------------------------
Several comments reported that countries determined to compete in
the global marketplace, including Switzerland, Australia, Thailand,
Uruguay, and Ecuador, recognize an acceptable hemp THC limit of 1.0
percent. According to comments, the international market settled on the
1.0 percent THC limit after numerous countries tested hemp over many
years. Comments recommended the IFR incorporate the same standard.
Comments asserted that the rights of Indian Tribes and small Tribal
farmers should be protected by allowing greater flexibility in the hemp
production regulations overall, consistent with Tribal self-government.
For example, comments said that Indian nations should be recognized to
have authority to grow hemp with up to 1.5 percent THC and should not
be restricted to 0.3 percent.
One comment explained that their company has focused on breeding
efforts to develop genetics that produce CBD-rich hemp with the lowest
possible THC concentrations. The commenter claimed their company has
harvested millions of pounds of hemp compliant with the 0.3 percent
total THC standard since 2017. The comment said they produced 25
million rooted cuttings this spring--enough, according to the comment,
to produce biomass for the entire country, and the commenter assumed
they were not the only ones who had done so. The comment asserted
further that the global standard for THC concentration is 0.2 percent
and that to be competitive, U.S. production must adhere to a similarly
strict standard.
Although asserting that the IFR hemp THC level of 0.3 percent is
not commercially reasonable, some comments acknowledged that only
Congress could change the statute to allow a higher limit, and some
commenters offered to serve as resources in that effort. Other comments
urged USDA to work with Congress to raise the THC threshold.
AMS response: Congress defined hemp in the 2018 Farm Bill as
Cannabis sativa L. with a delta-9 tetrahydrocannabinol concentration of
not more than 0.3 percent on a dry weight basis. Any change to the
statutorily established threshold of THC concentration requires an
amendment to the statute. The CSA defines marijuana as cannabis that is
over the 0.3 percent THC level. AMS has no discretion to change the THC
level or to treat States and Tribes differently as the 2018 Farm Bill
applies to all production of hemp in
[[Page 5619]]
the U.S. Tribes do not have the authority to grow hemp with up to 1.5
percent THC as this would violate the 2018 Farm Bill and the CSA.
Tribes' powers of self-government may be constrained by acts of
Congress in accordance with Congress' constitutional authority to
regulate commerce with Indian Tribes.
AMS notes that there seems to be confusion amongst some commenters
on the THC level stated in the 2018 Farm Bill and the IFR's definition
of acceptable hemp THC level. The acceptable hemp THC level in this
final rule includes the 0.3 percent established in the Farm Bill plus
any measure of uncertainty due to laboratory testing.
Regarding the comment citing the news story, AMS believes the
commenter misconstrued the article's meaning. The article cited by the
commenter explained that following passage of Texas's law that
legalized hemp in early 2019, the number of marijuana prosecutions in
the State plummeted, due in part to the lack of adequate and affordable
criminal laboratory resources. According to the article, prosecutors
were less likely to expend resources on low-level marijuana charges
where the likelihood of conviction is low. The article described
anticipated release of a new lab testing method that only determines
whether THC concentration is above or below 2 percent for criminal
testing purposes. According to the article, even though 2 percent is
higher than the State's legal hemp limit of 0.3 percent, such testing
would nevertheless be adequate for Texas law enforcement purposes,
since nearly all marijuana plant prosecutions in the State involve THC
concentrations of 12 percent or more. AMS believes neither the article
nor the State are advocating legalization of hemp THC concentrations of
up to 2 percent, but that Texas law enforcement is merely using that
limit as a convenient way to determine whether to pursue criminal
prosecution.
In response to concerns that producers could unwittingly become
illegal marijuana farmers without greater flexibility in the rule, AMS
has modified the negligent violation threshold as explained in the
section responding to comments on the negligent violation threshold.
AMS also notes, however, that it does not have any authority over how
the DEA chooses to enforce compliance with the CSA.
In the final rule, AMS is implementing a nation-wide domestic hemp
production program as contemplated by the 2018 Farm Bill. It is not
amending Risk Management Agency's regulations regarding crop loss or
repayment payments. Thus, comments regarding those regulations are
outside the scope of this rule.
Testing for Total THC
The IFR requires that when hemp THC levels are measured using post-
decarboxylation or other similarly reliable methods, the total THC
concentration level measured must include the potential to convert THCA
into THC.
Comments: Some comments agreed that the measurement of delta-9 THCA
should be added to the measurement of delta-9 THC and reported as total
THC used for determining compliance with the hemp program requirements,
as this is what many hemp producing States are already doing under
State programs. A comment from an association of Departments of
Agriculture reported that many States responding to their survey
supported testing for total THC in this manner.
Other commenters disagreed. According to one comment, only 22 of 47
States with State-level hemp programs test for total THC. The comment
said that 18 States do not currently test for total THC, and that 7
States' rules are ambiguous on this point. Other comments reported that
State programs currently testing for only delta-9 THC are confident
that producers are not selling ``hot'' crops.
One comment said it is irrational to subject hemp biomass to
decarboxylation when most biomass harvested for processing into
increasingly popular consumer goods or industrial products will never
even be decarboxylated.
Another comment explained how USDA cannot alter the definition of
hemp as set forth in the 2018 Farm Bill. The comment said that there
should not be a ``total'' THC mandate and, rather, the plain reading of
the 2018 Farm Bill establishes that delta-9 THC is actually the
determinative factor. The comment went on to explain how other State
and Federal agencies also rely only on delta-9 THC when making critical
distinctions with respect to hemp, such as the DEA and the FDA, to
determine whether a substance is controlled and subject to criminal
penalties. The comment presented an alternative testing methodology
where testing methods must be able to determine the potential for THCA
to convert into delta-9 THC, and the test result must reflect that
ability as well as the aggregate computation, but the controlling
factor whether a crop meets the definition of hemp and is within the
``acceptable hemp THC level'' relies only upon the delta-9 THC element.
Thus, for compliance purposes, delta-9 THC is the standard, and the lab
report must at least reflect THCA, delta-9 THC, and the Total THC
results, but Total THC should not be determinative in whether a farmer
has to destroy his crop.
Industry impacts. Commenters asserted that testing for THCA
concentration, a component they argued which is not psychoactive, would
vastly undermine the efficient production of hemp and the growth of the
industry. Some comments supported the 0.3 percent THC standard, but
said requiring testing for total THC goes beyond what is statutorily
required, to the detriment of producers. Commenters argued that the
difference between levels of delta-9 THC and total THC in hemp is
significant, and that crops that would otherwise be compliant measuring
only for delta-9 THC would not be compliant when measuring for Total
THC. Comments asserted that testing for total THC with a threshold of
0.3 percent effectively lowers the allowable hemp THC level to an even
lower limit.
Comments also described the correlation between total CBD and total
THC production and explained that producers trying to maximize CBD
production will not be able to do so successfully if total THC levels
are restricted to 0.3 percent. One comment claimed that a farmer can
produce hemp plants with up to 25 percent cannabinoid content while
staying under 0.3 percent delta-9 THC limit, but that the farmer would
have to plant twice as many acres of a less potent hemp variety to
produce the same amount of CBD end product and stay compliant under the
IFR's Total THC limit.
Several comments reported that some CBD hemp processors reject
product with CBD amounts of less than 8 percent. According to comments,
breeders have worked years to develop cultivars that meet the 0.3
percent delta-9 THC threshold, but many cultivars would not be
compliant under the total THC limit. Comments predicted that with a
standard of 0.3 percent total THC, growers will stop growing hemp for
CBD because the risk is too high that their hemp crops will exceed the
limit and be destroyed, defeating the purpose for growing crops for the
potential high returns related to CBD production. Comments further
lamented that the industry would lose investments they've already made.
According to comments, many States that have only been measuring
delta-9 THC under 2014 Farm Bill pilot programs have developed
companion
[[Page 5620]]
marketing programs that have been tailored to complement State hemp
production programs. Comments asserted the total THC limit in the IFR
would significantly impact these new and emerging markets and cripple
the industry in those States, preventing them from selling their
product.
Some comments claimed that common industry practice is to measure
THC and THCA independently. Comments recommended USDA treat THC and
THCA as two separate molecules and only be concerned with the amount of
THC in a sample, rather than total available THC.
One comment recommended that if USDA wants to test for total THC,
the limit should be raised to 0.694 percent, with negligence set at
1.094 percent, and that growers whose samples measure between the two
limits should be allowed to retest samples with up to two certified
labs of their choice at a cost of $500 each. Another comment
recommended that samples be tested for THC and THCA separately, with
limits of 0.3 and 1.0 percent, respectively.
AMS response: The 2018 Farm Bill requires that State and Tribal
plans provide a procedure for testing, using post-decarboxylation or
other similarly reliable methods, delta-9 tetrahydrocannabinol
concentration levels of hemp. In order to use post-decarboxylation, the
sample must be heated or a conversion made to account for the lack of
heating process. This means that the total THC must account for THCA
and delta-9 THC.
Currently, some States and Indian Tribes use gas chromatography
(GC) to test hemp. In GC testing, heat is applied to the sample which
THCA, producing delta-9 THC (a psychoactive compound), so that the
final delta-9 THC result is actually a total THC result. GC is the more
traditional technique used for THC testing and GC results are typically
reported as ``delta-9 THC'' without distinguishing that the reported
delta-9 THC is actually total THC.
Liquid chromatography (LC) testing typically does not involve the
use of heat, so the THCA in a sample does not decarboxylate. In LC,
results for THCA and delta-9 THC are obtained separately and can be
reported separately. Cannabis naturally contains more THCA than delta-9
THC; if the THCA concentration is ignored while testing by LC, it is
improbable to correctly distinguish hemp varietals from drug varietals.
A total THC needs to be calculated post-testing in order to determine
the ``post-decarboxylation'' delta-9 THC value as required by the 2018
Farm Bill. In this way, all testing methodologies report the same
information.
AMS acknowledges that some States do not currently test for total
THC and that switching to testing for total THC may have a negative
impact on those State programs. Most laboratories that use LC obtain
THCA results and delta-9 THC results in the same analysis, so the
information should be readily available to incorporate a calculation
for Total THC. The opposite is also true. If USDA was to ignore the
statutory requirement of using post-decarboxylation or other similarly
reliable methods and allow for THC levels that do not account for
decarboxylation, States and Tribes that currently require testing for
total THC could experience a negative impact. When States or Tribes use
different methods to measure THC, it impacts commerce because producers
are not all on the same playing field. Also, since total THC at 0.3
percent is harder to obtain, those States and Tribes currently using
total THC have been potentially selling less or destroying more hemp.
Further, many in the industry have already made the switch to total THC
since the IFR was published, diminishing the impact.
AMS consulted with the Departments of Justice and Health and Human
Services to develop the IFR. The Drug Enforcement Administration's
Analysis of Drugs Manual cites GC methodology, initially labeling
results as delta-9 THC and then defining total THC and instructing how
to determine compliance using total THC.
In order to provide flexibility to States and Indian Tribes
administering their own hemp production programs, alternative testing
protocols will be considered by AMS if they are comparable and
similarly reliable to the baseline mandated by section 297B(a)(2)(ii)
of the AMA and established under the USDA plan and procedures. Updated
USDA procedures for sampling and testing will be issued concurrently
with this rule and will be provided on the USDA website.
This final rule covers hemp production. Hemp products are regulated
under the Food and Drug Administration and its various statutes.\15\
---------------------------------------------------------------------------
\15\ The 2018 Farm Bill explicitly preserved the authority of
the U.S. Food and Drug Administration (FDA) to regulate hemp
products under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
and section 351 of the Public Health Service Act (PHS Act).
---------------------------------------------------------------------------
Statutory Compliance and Congressional Intent: Several comments
expressed concern about regulatory inconsistency between the 2018 Farm
Bill language testing methods and the IFR requirements. Commenters
urged USDA to reconsider the legislative record and Congress's intent
in passing the 2014 and 2018 Farm Bills. According to numerous
comments, the plain language of the 2018 Farm Bill statute does not
support the IFR's requirement to test for total THC. Commenters
asserted that if Congress had intended samples to be tested for total
THC, they would have so specified, rather than making the specific
reference to delta-9 THC in the statute. Comments concluded that
concentrations of THCA in hemp should be irrelevant to its legal status
under the regulations. One comment characterized ``decarboxylated
value'' as a new legal term and questioned USDA's authority under the
2018 Farm Bill to create such a term. One comment went on to say that
the term ``potential conversion'' as appearing in the IFR is offensive
because Federal criminal law does not convert a legal substance into an
illegal one simply because the substance has the ``potential'' to be
converted.
Several comments cited a letter from Senators Merkley and
Wyden,\16\ authors of the Hemp Farming Act of 2018 that was included in
the 2018 Farm Bill, as evidence that the IFR wrongly requires testing
of Total THC. In that letter, Senators Merkley and Wyden asserted that
requiring hemp samples to be tested using methods by which the reported
THC concentration accounts for the conversion of THCA to THC ``is a
complete reversal of the Congressional intent expressed in that law and
requires testing that Congress specifically did not include.'' Comments
also asserted that the Farm Bill definition of hemp is clear in that
``all derivatives, extracts, cannabinoids, isomers, acids, salts, and
salts of isomers, whether growing or not'' of the hemp plant are
expressly lawful so long as the pant does not contain a delta-9 THC
concentration of above 0.3 percent. Thus, according to these comments,
the IFR required measurement of a lawful plant-based acid when
distinguishing between hemp and marijuana under the Controlled
Substances Act, and such a requirement contradicts the plain language
of the Farm Bill and the spirit of the law.
---------------------------------------------------------------------------
\16\ https://www.merkley.senate.gov/news/press-releases/wyden-
merkley-to-dea-interim-rule-on-hemp-contradicts-congressional-
intent-by-criminalizing-intermediate-steps-in-hemp-processing-
2020#:~:text=Authors%20of%20the%20provision%20in,by%20seriously%20mis
understanding%20hemp%20processing. See https://beta.regulations.gov/comment/AMS-SC-19-0042-0884.
---------------------------------------------------------------------------
[[Page 5621]]
One comment asserted that requiring test reports of THC
concentration to account for conversion of THCA into THC effectively
mandates that only test methods relying on post-decarboxylation be
used, nullifying Congressional intent that other similarly reliable
methods that don't require conversion of THCA to THC should be
authorized. The comment recommended revising the rule to comply with
the Congressional mandate to allow testing through other similarly
reliable methods.
AMS response: AMS is not making a determination of Congressional
intent when passing the 2018 Farm Bill provision for hemp. Instead, AMS
is following the plain statutory language that states that a State or
Tribal plan shall be required to include ``a procedure for testing,
using post-decarboxylation or other similarly reliable methods, delta-9
tetrahydrocannabinol concentration levels of hemp produced in the State
or territory of the Indian Tribe''.
International Impact: Some comments asserted that the average
global delta-9 THC limit is 1.0 percent. Others claimed that Europe has
adopted a 0.3 percent THC limit, but that it applies only to delta-9
THC and not total THC. Comments contend that American hemp production
required to comply with at 0.3 percent total THC limit will be
disadvantaged in the international marketplace. Comments proposed that
matching a global standard by establishing a higher delta-9 THC
threshold or total THC limit would strengthen U.S. producers' market
competitiveness. Other comments warned that reducing the domestic hemp
supply by imposing the IFR's 0.3 percent total THC limit will
incentivize importation of hemp biomass and hemp derivatives produced
in countries with lower labor costs and less restrictive regulatory
regimes, and that domestic hemp and hemp derivatives will be priced out
of the market.
AMS response: The 2018 Farm Bill authorizes USDA to issue
regulations to regulate the production of hemp and defines hemp in
terms of the concentration of THC in a Cannabis sativa L. plant. A
Cannabis sativa L. plant is considered hemp, and therefore not a
controlled substance, if the THC concentration is not more than 0.3
percent on a dry weight basis. AMS does not have the discretion to
change this threshold in the definition of hemp even if this threshold
could impact the global competitiveness of U.S.-produced hemp.
Calculating Total THC
The 2018 Farm Bill and IFR identified and described the procedure
for testing THC concentration using post-decarboxylation or other
similarly reliable methods. The term decarboxylated was defined in the
IFR as 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
THC-acid. The term decarboxylated is also commonly used in science and
is the precursor to the term ``post-decarboxylation,'' which appears in
the 2018 Farm Bill's mandate on the acceptable cannabis testing
methodologies for identifying THC concentration levels. AMS adopted
this definition in this final rule.
Conversion Efficiency: Many stakeholders opposed USDA's conversion
formula described in the IFR. Comments claimed the IFR was based on 100
percent conversion efficiency, which is only achievable under
controlled laboratory testing conditions and is not possible outside of
a laboratory environment. One comment stated the IFR failed to account
for the inefficiency of the decarboxylation process. Numerous other
comments characterized the USDA formula as theoretical and explained
that the realistic conversion efficiency is between 30 and 75 percent.
For example, several commenters cited a peer reviewed study which found
72 percent to be a viable efficiency factor and provided the
calculation formula: Total Potential THC = (0.72) x [(0.877 x THCA) x
delta-9THC)]. Additionally, a commenter suggested USDA utilize three
different conversion factor tiers (0, 30, or 70 percent) depending on
the end-use varietal because the THC concentration varies by varietal.
The commenter argued that the conversion factors should reflect the
different end-uses.
One comment said the calculation for ``Total Potential THC'' should
be defined and incorporated into the final rule because the
decarboxylation percentage definition is critical for standardization
and uniformity in the industry. Otherwise, according to the comment,
States could adopt different decarboxylation percentages in their
equations, causing confusion for growers. The comment gave the
following formulas as examples: (Total potential THC = 0.877 x percent
THCA + percent delta-9 THC) as compared to (Total Potential THC = 0.877
x 0.70 x percent THCA + percent delta-9 THC), assuming a 70 percent
THCA decarboxylation to delta-9 THC rate.
Another comment explained the need to include delta-8 THC into any
calculation for the future state delta-9 THC.
AMS response: Delta-8 THC only exists in a trace amount in
marijuana which has a high Delta-9 THC concentration. The Delta-9 THC
amount is already low in hemp, so the concentration of Delta-8 THC
would be basically undetectable in hemp. A quote from the ``WHO Expert
Committee on Drug Dependence Critical Review--Isomers of THC''
regarding the relative amount of Delta-8 THC to Delta-9 THC that can be
found at https://www.who.int/medicines/access/controlled-substances/IsomersTHC.pdf?ua=1.
The above range means that Delta-8 THC occurs at a level that is
roughly 1000 times less than Delta-9 THC. So, if Delta-9 THC was
observed at 0.3 percent in hemp, then the Delta-8 THC concentration
would be roughly around 0.0003 percent. This contribution is completely
negligible and contributes nothing significant to the total THC
content. The trace amount of Delta-8 THC is about 100 times less than
the uncertainty (MU) of the test method, further demonstrating that it
is insignificant and not worthy of consideration in the final
assessment of THC for hemp compliance.
AMS is adopting the calculation provided in the IFR for determining
total THC. However, the calculation has been clarified to explain the
use of the molar conversion ratio to mathematically convert THCA to
delta-9 THC. As written in the IFR, the calculation may have been
misunderstood as containing a conversion efficiency factor, which is
not the case. THCA cannot be added to delta-9 THC without accounting
for the difference in molecular mass. Using stoichiometry, a molar
conversion ratio (0.877) is used to mathematically convert THCA in
terms of delta-9 THC. The molar mass of THCA is 358.47 g/mol and the
molar mass of delta-9 THC is 314.45 g/mol. In other words, the mass of
THCA has to be adjusted or multiplied by 0.877 to be comparable to the
mass of delta-9 THC.
The 2018 Farm Bill requires that the THC content be expressed post-
decarboxylation, which means that the conversion of THCA into delta-9
THC to account for the potential total THC in a sample must be taken
into account. The term ``potential'' is used because it is not possible
to readily, consistently, and reliably calculate the precise extent of
[[Page 5622]]
the conversion of THCA to THC under any and all circumstances.
Therefore, the calculation for total THC assumes 100 percent conversion
efficiency and is hereby retained in this regulation. The calculation
for total THC [total THC = (0.877 x THCA) + (delta-9 THC)] assumes that
100 percent of the THCA is decarboxylated, producing to delta-9 THC,
meaning that it gives the maximum (or potential, or theoretical) total
THC. The final rule includes a definition for total THC to provide more
specificity on this issue. This is standard procedure for how
theoretical yield is calculated in chemistry. The issue is that
theoretical yield does not always equal actual yield. Just because a
maximum total THC can be calculated does not mean that the maximum is
always obtained; however, there is potential for this maximum to be
obtained. The amount of THCA that actually decarboxylates, producing
delta-9 THC, is dependent on multiple variables; primarily, the amount
of heat it is exposed to and the amount of time it is exposed to that
heat. These variables, in turn, depend on what is being done to a
cannabis sample (tested via LC, tested via GC, used for smoking, used
for extraction, etc.).
Incorporating the use of a conversion efficiency factor into the
calculation is problematic due to these variables. Designating
different conversion efficiency factors based on intended end use is
not practical as the factors can still vary. For example, if an end-use
of extraction is intended, there are many different types of extraction
processes and even within one specific process there are still many
different variables that will affect the conversion efficiency.
Ultimately, there is no way to standardize a conversion efficiency
factor based on end-use, methodology, or processing. The infrastructure
does not currently exist to measure and monitor conversion efficiency.
In terms of conversion during instrumental analysis, many
commenters referenced a study conducted by Dussy \17\ that determined a
conversion efficiency factor for a specific GC setup. The author of the
study recommends determining THCA and delta-9 THC separately and
calculating total THC (using the equation the IFR stated to use). The
author says that ``every total [Delta]9 THC value determined after
decarboxylation [by using GC] gives a minimal content rather than an
exact value''. Therefore, the author proposes that labs using GC should
calculate their own method's conversion efficiency and then apply their
efficiency to their result to increase their total THC value to make it
comparable to LC. This is the opposite of what many commenters are
proposing in that they wanted LC methods to incorporate conversion
efficiency into their LC results to make total THC lower. The further
complication of this ``opposite'' approach is that it is impossible
without having a single conversion efficiency which, as stated
previously, cannot be agreed upon and can vary widely. Furthermore, no
matter how the conversion efficiency was to be applied, requiring each
lab to determine their own method's efficiency would require
significant effort.
---------------------------------------------------------------------------
\17\ Dussy F.E.; Hamberg, C.; Luginb[uuml]hl, M.; Schwerzmann,
T.; Briellmann, T.A. Isolation of [Delta]9 THCA-A from hemp and
analytical aspects concerning the determination of [Delta]9 THC in
cannabis products. Forensic Science International, 149, 3-10, 2005.
---------------------------------------------------------------------------
Delta-8 THC is a cannabinoid that can be formed from delta-9 THC.
It is typically only found in very small quantities in plants, if it is
found at all, and is more often obtained by growing a plant with high
delta-9 THC and then converting the delta-9 THC into delta-8 THC
through an extraction and conversion process in a lab to make a
distillate product. It is rarely included in total THC calculations and
many labs do not test for it. Delta-8 THC is unrelated to the 0.3
percent delta-9 THC limit or the ``post-decarboxylation delta-9 THC''
that are defined and required in this final rule.
Similarly Reliable Testing Methods
The 2018 Farm Bill states that State, Tribal, or USDA plans shall
include ``a procedure for testing, using post-decarboxylation or other
similarly reliable methods, delta-9 tetrahydrocannabinol concentration
levels of hemp.''
The IFR included two examples of standard industry post-
decarboxylation testing methods that meet 2018 Farm Bill requirements:
Gas and liquid chromatography with detection. AMS selected these
standard methods of chromatography as the best options for testing but
also provided flexibility for alternative sampling and testing
protocols if they are comparable and similarly reliable to the baseline
mandated by the 2018 Farm Bill and established under the USDA plan and
procedures.
Comments: Some comments expressed support for the use of post-
decarboxylation. One comment described liquid chromatography as a
preferable testing method over gas chromatography because there are no
published methods for gas chromatography that show 100 percent
conversion of THCA to THC. Comments suggested liquid chromatography is
more accurate and representative than gas chromatography. USDA received
a comment that because Tribes often do not have ready access to gas
chromatography and may only be able to access liquid chromatography,
the rules need to allow for a more lenient formula.
Many more comments opposed the IFR requirement to use post-
decarboxylation testing methods on the grounds that the IFR too
strictly interpreted or unnecessarily developed regulatory requirements
that are not consistent with the statutory language of the 2018 Farm
Bill. Comments stated that USDA should be flexible and allow for
measuring THC levels with ``similarly reliable methods,'' as provided
in the statute. Comments claimed that the IFR's exclusive endorsement
of gas or liquid chromatography methods ignores this statutory
flexibility. Comments further asserted that these two methods may
overstate THC levels in hemp samples and that USDA should approve
alternative reliable methods that may produce more accurate results.
According to some comments, reliable testing methods have emerged
that do not necessitate decarboxylation to accurately measure THC
concentrations. For example, comments claimed that some States
recognize genetic testing that measures the ratio of cannabidiol to THC
in a sample or that confirms a stable cultivar's taxonomic
determination in lieu of post-decarboxylation testing to verify
compliance with THC limits. Comments explained that genetic testing
could include testing seed or testing during early plant growth stages,
instead of depending on chemical analyses to measure THC levels in
mature plants, which may be inconsistent under unpredictable growing
conditions or dependent upon the time of sampling or the specific part
of the plant that is sampled.
Comments advocated removing the Total THC testing requirement and
recommended USDA work with scientific and agricultural communities to
ensure testing standards are established and similarly reliable methods
are developed that will accurately identify and measure THC without the
forced conversion of other cannabinoids, isomers, and/or acids.
States Operating under 2014 Farm Bill Authority: Comments said that
USDA should recognize that States have been effectively regulating hemp
production using approved testing methods under 2014 Farm Bill pilot
[[Page 5623]]
programs. Comments argued that by applying the IFR's new testing
standard, certain hemp plants that are legally grown under one or more
of the existing pilot programs are converted into plants that violate
the 2018 Farm Bill. Comments contended that while USDA will argue that
States and Tribes can propose a testing method other than post
decarboxylation, the alternative method still has to measure potential
conversion of THCA into THC.
Comments said further that the IFR must consider that hemp testing
is an evolving science and that THC testing methods are likely to
change over time. They stated that imposing new testing requirements is
adding costs for growers, marketers, and regulators, and is limiting
the number of labs that can perform these tests, for unnecessary and
possibly impermissible reasons. Finally, comments questioned whether
USDA has the authority to impose new testing requirements when the
statute spells out the testing standards to be applied in granting
approval to State and Tribal plans.
A comment cited case law that held that under the Administrative
Procedure Act (APA), agency decisions must be reasonable and based on
factors and evidence that support the decision, divergent views
notwithstanding. It suggested the IFR is arbitrary and capricious under
the APA because USDA (1) ``has relied on factors which Congress has not
intended it to consider, '' (2) ``entirely failed to consider an
important aspect of the problem,'' (3) ``offered an explanation for its
decision that runs counter to the evidence before the agency,'' and (4)
has made a decision that ``is so implausible that it could not be
ascribed to a difference in view or the product of agency expertise.''
It further claimed that a court must sustain an agency's action unless
it determines that the agency committed a ``clear error in judgment.''
The commenter asked that their comment be considered within the context
of these legal standards, and argued that THCA is not psychoactive; but
can be converted into delta-9 THC through a chemical reaction, and that
such a reaction may cause otherwise lawful hemp plants to test ``hot.''
The comment projected further that such ``hot'' plants will require
disposal, causing a significant and unnecessary loss of hemp
production, which will in turn reduce economic development and job
growth in many rural communities.
The comment said post-decarboxylation testing was not required
under the 2014 Farm Bill pilot program and the same plants that are
legal under 2014 Farm Bill could be illegal under the IFR. The comment
recognized that the pilot program will not be authorized after 2021 but
said current disparate treatment under the two laws is problematic.
AMS response: The 2014 Farm Bill included a 0.3 percent THC level
but did not include the requirement for this measurement to account for
decarboxylation. Thus States have the flexibility to determine testing
methodologies. The 2018 Farm Bill states that procedures for testing
use post-decarboxylation or other similarly reliable methods to
determine delta-9 tetrahydrocannabinol concentration levels in hemp.
AMS stated in the IFR and further adopts the language in this final
rule that at this time two methods meet this requirement for
decarboxylation. The current acceptable testing methods include gas and
liquid chromatography, including LC with UV detection. As other testing
methods and alternatives are developed by industry, AMS will review and
evaluate their compliance with the 2018 Farm Bill. At this time,
genetic testing has not been determined to be a similarly reliable
testing methodology.
This final rule provides States and Indian Tribes the option to
develop different sampling methodologies based on end use, including
grain and fiber, to better account for differences in these plants.
Biomass only needs to be tested after remediation to ensure that the
sample that represented the plant that once tested above the acceptable
THC level did not result in the plant being a controlled substance.
This final rule does not set requirements for testing final products--
but hemp plants, regardless of their end use, must still use the same
testing procedures.
Although the USDA plan does not allow for sampling based on end
use, AMS will study the experience of States and Tribes that adopt
methodologies based on end use. If it appears that the data and
experience of those States and Tribe suggest that their methodologies
may be adaptable to the USDA plan, AMS may explore a sampling scheme
based on end use for producers under the USDA plan in the future
through notice and comment rulemaking.
License Application Period
AMS received comments on the timeframe established in the IFR for
submitting applications for a USDA license. The application period
extends between August 1 and October 31.
Comments: Several comments opposed the August-through-October
window for USDA license applications and renewals. They explained that
many outdoor hemp crops are harvested in September and October and that
farmers are busy with harvest activities related to other crops as well
during that time of year. Comments noted that farmers typically
finalize decisions about the coming crop year during the winter, after
having time to attend industry and trade conferences, enter into
production contracts, and obtain crop loans and insurance. Thus,
according to comments, a longer application window or a later
application window would give farmers time to plan for the coming year
and submit hemp production license applications as appropriate.
Comments also noted that a longer application period would give
producers time to complete the mandatory background check. Some
comments recommended the application period be extended to December 31.
Others recommended a winter application period of January 1 to March
15.
Other comments recommended even greater flexibility in application
periods. Comments explained that harvest cycles for hemp growers may
vary regionally and by operation type. They said a significant number
of hemp operations involve year-round cultivation, maintenance of
mother clones, clone propagation, indoor cultivation, and/or tissue
culture. Time and resources to gather and submit paperwork would not
coincide with the down-cycles in productivity and would strain these
types of operations. Some recommended USDA adopt a year-round, rolling
application period with different deadlines for different operation
types or sizes. One comment said it was unclear in the IFR whether
State and Tribal plans were required to adhere to the same window
provided for under USDA's plan. Several comments urged USDA to provide
greater regulatory flexibility at the State and Tribal levels to
determine the appropriate application and renewal timeframes for their
jurisdictions. An example was given of a State's agriculture department
transitioned enrollment from a restricted to an unrestricted timeframe
to better manage the logistical challenges related to the enrollment
period.
AMS response: AMS agrees with the commenters opposed to a limited
USDA license application window and will allow for applications to be
submitted for a USDA license year-round. This will provide greater
flexibility to hemp producers to determine when to apply for a license
or renew their license. This decision recognizes the different regional
harvest timetables and production types used by hemp producers, and how
flexible timetables
[[Page 5624]]
may allow producers to prepare applications during lower level periods
of production activity thereby reducing some of producers' burden on
time and resources when the producer is planning the next planting
cycle(s). States and Tribes can determine their license application
window as it best meets their programs.
FSA Reporting and Information Sharing
AMS received comments on the IFR requirement that hemp producers
report acreage and provide licensing information to USDA's Farm Service
Agency (FSA). Hemp producers must provide FSA information about their
hemp crop acreage, such as its location and size, and must provide the
producer license or authorization number issued under the hemp
production plan under which they operate. States, Indian Tribes, and
USDA must collect the same information, as well as other producer
information, under their respective plans. USDA then assembles and
maintains FSA and plan information and makes it available to law
enforcement agencies, as required under the 2018 Farm Bill.
Comments: Several comments expressed strong support for FSA
programs generally, acknowledging that FSA programs provide farmers
valuable access to Federal programs and funding, and that registering
crop acreage with FSA would help mainstream hemp production within
agricultural communities. Comments noted that requiring hemp growers to
register with FSA is similar to registration requirements for growers
of other commodities and that FSA already compiles reports about other
crops. However, many commenters opposed the requirement to register
with FSA when they are already required to provide the same information
to their licensing authority. Comments argued that the duplicative
reporting requirement is unnecessarily burdensome to farmers, could be
confusing, and could discourage farmers from seeking hemp production
licenses or from growing hemp. One comment speculated that confusion
about the duplicative requirement could lead to unintended violations
by growers who don't comply. Other comments speculated that lower
program participation would inhibit industry growth and deprive States
and Indian Tribes of licensing fees that enable them to fund their
respective production plans.
Comments noted that the statute does not specify dual reporting of
crop acreage to both FSA and the plan authorities under which they
operate.
Several comments took exception with the IFR's assumption that most
hemp farmers are already registered and familiar with FSA and its
programs. Comments from some State agriculture departments asserted
that within their jurisdictions most farmers in general do not already
work with FSA.
One comment asserted that participation in FSA programs is
voluntary and that hemp growers should not be precluded from
participating in the commenter's State program because they forego FSA
registration. Other comments suggested that farmers growing hemp for
personal use and hemp farmers also growing medical marijuana may be
hesitant to register crop acreage with Federal agencies.
One comment expressed concern about FSA staffing in rural areas and
asked USDA to increase funding to support additional reporting
obligations. Another comment suggested USDA develop and fund one
standardized reporting program for all plans and growers that would
decrease program reporting burdens for all entities. Some comments
encouraged streamlining collection of crop acreage information by
allowing the use of open-source GIS mapping instead of FSA data and
reporting tools. Comments also suggested USDA could rely on States and
Tribes to provide grower crop acreage and registration information
since they already collect it. Several comments recommended eliminating
the FSA registration requirement altogether.
AMS response: AMS acknowledges the FSA reporting requirement may
present a hurdle for certain hemp producers, particularly new and
beginning farmers, farmers in rural locations, and farmers located in
Tribal territories. However, AMS determined that the FSA reporting
requirement is essential for two key reasons: Real-time data collection
and field-based resources.
First, USDA is required under the 2018 Farm Bill to provide law
enforcement with certain ``real-time'' information about who is growing
hemp, whether their license is in good standing with the regulatory
body issuing the license, and the location(s) of where hemp is being
grown. The daily collection of this information through FSA county
offices enables USDA to easily transmit the required information to law
enforcement. FSA maintains the technology necessary for data collection
and geographical land identification. These tools will provide easy
access to information needed for law enforcement and for other
agricultural programs. This information is compiled in one system,
using an information sharing mechanisms currently used by law
enforcement and which they are familiar with, and transmitted to law
enforcement in a safe manner, which otherwise would not be as readily
available through State and Tribal reporting. States and Tribes must
provide information to USDA in a format that is compatible with USDA's
information sharing system. USDA will work with States and Tribes on
system format and other information necessary to share information.
Secondly, FSA's county network is expansive with over 2,000 field
office locations. FSA offices provide services both in person and
virtually to accommodate the needs of producers.
Its mission runs parallel to other USDA agencies including Risk
Management Agency, Natural Resources and Conservation Service, and
Rural Development, each of which provide a wide range of benefits and
services to local communities. AMS noted that in many cases, FSA is co-
located with other Federal, State and county-level government offices
which means a variety of services are provided through one central
location. These services frequently include information on insurance
and risk management programs, conservation and irrigation technical
expertise, agricultural credit for operating or marketing, and rural
housing loans. As such, the requirement is considered by AMS to be
particularly important to new and beginning farmers who traditionally
are not familiar with the wide range of programs and services offered
by Farm Service Agency and the other USDA agencies.
Definition of ``Lot''
AMS received comments on the definition of ``lot'' for providing
geographical determination of hemp production and for sampling
purposes. One comment explained that nursery operators and their field
operating counterparts may need to file hundreds of permits for a
single greenhouse under the IFR. The comment described as an example
one greenhouse at a nursery, which may have upwards of 36 benches, in
which each bench could have 20 different hemp varieties growing at any
one time. The comment said that the IFR would require that single
greenhouse to have 720 ``lots,'' and based on most States' current
rules, 720 containment plans, destruction plans, and transportation
notices when any plants are moved--all possibly requiring agency
approval prior to any action
[[Page 5625]]
being taken. It further explained that the growing cycle for nursery
stock could be as short as five to six weeks, and different varieties
could take their place. The comment said a nursery with five or six
greenhouses on a relatively small acreage may have to register
thousands of lots and submit thousands of associated plans. It
recommended that such a nursery should only be required to designate
the actual greenhouse or indoor growing structure itself as used for
the cultivation of hemp generally, and the term ``lot'' should not be
defined to include any restriction or limitation to the same hemp
varietal. The comment proposed revising the definition of ``lot'' to
mean a contiguous area in a field, greenhouse, or indoor growing
structure used for the cultivation of hemp.
AMS response: In this final rule, AMS is clarifying that the term
``lot'' has the same meaning as other terms used by FSA, as found in 7
CFR 718.2, to mean the same production area, such as ``farm,''
``tract,'' ``field,'' and ``subfield.'' AMS uses the term ``lot'' to
help growers and oversight officials identify farm locations, field
acreage, and variety (i.e., cultivar). Although a hemp producer must
report their ``lot'' information to FSA, when a producer visits the FSA
office to report hemp crop acreage, FSA staff will determine the
appropriate designation for the specific location(s) where hemp is
being grown. FSA staff will not provide a ``lot number'' to producers
as described in the IFR, but instead designate either a ``field'' or
``subfield'' as the unique identifying number. This number is
considered equivalent to a ``lot number.''
A lot must always contain the same variety or strain of cannabis
throughout the area because the final rule requires lot-based testing.
Certified Seed
The IFR explains that under the 2014 Farm Bill, various States
developed seed certification programs to help producers identify hemp
seed that would work well in their specific geographic areas.
Comments: Some comments concurred with USDA's decision not to
introduce a hemp seed certification program with the IFR. Numerous
commenters said that such a program would not be appropriate, that it
would be too difficult to regulate, or that it would be premature now.
Other comments said a federal hemp seed certification program is not
necessary because some States and Indian Tribes had already developed
such programs for their jurisdictions or are capable of doing so.
Numerous comments said they recognized the difficulty of developing a
hemp seed certification program but nonetheless urged USDA to pursue
what they characterized as an important effort to allow for consistency
among hemp producers when resources permit.
One comment asserted that seed certification is key to a regulated
hemp industry and explained that certification is a common practice in
the international seed industry. Several comments contended that USDA
must develop a seed certification program to prevent hemp growers from
purchasing and planting seed of unproven quality--or of the wrong
varieties for their purposes--and risking unnecessary financial loss
and regulatory violations. Comments claimed that hemp farmers already
have difficulty verifying the origin, genetics, and reliability of hemp
varieties currently on the market, and that a seed certification
program would help farmers know whether seed they purchase is
appropriate for their growing conditions or intended hemp product end-
use. Numerous comments inferred that a seed certification program would
identify hemp varieties that had been tested and proven to reliably
produce compliant hemp plants in specific geographic areas.
Some comments argued USDA should not engage in hemp seed
certification because plant genetic expression is influenced by
environmental conditions and seed certifiers cannot guarantee plants
will have THC concentrations within the acceptable range. Other
comments countered that assertion and referenced a comment that
reported on the analysis of cannabis genome trials and concluded that
cannabinoid concentration is 80 percent or more controlled by genetics
rather than environmental conditions.
Comments claimed that hemp varieties developed under proper
breeding programs and certified in the European Union and Canada had
been proven to have stable cannabinoid profiles across multiple
regions. They suggest that comparable results could be achieved under a
USDA seed certification program.
A comment claimed that the lists of acceptable/approved varieties
provided by the processor and/or the governing authority in the State
in which the hemp is grown needs to be updated soon and regularly. The
policy language may be acceptable, but these lists need attention
quickly so that ill-suited varieties are not planted and insured when
planted outside of the area and not likely to perform as well.
Some comments asserted it is not necessary for USDA to develop a
seed certification program now because the Association of Official Seed
Certifying Agencies (AOSCA) has already established national standards
for hemp field crop cultivars and is reviewing issues related to the
development of certification standards for feminized seed and clones of
CBD hemp. Other comments recommended USDA adopt AOSCA standards in the
development of a Federal seed certification system, and several
comments said that some States have already adopted AOSCA protocols for
production of certified seed for commercial sale to farmers. For
example, a comment stated that a state currently recognizes 17 hemp
seed varieties that have been certified for use in that state in
accordance with AOSCA standards. The comment said the state encourages
farmers to use certified seed when possible and the state intends to
rely on certified seed to streamline the hemp testing program in the
future.
A comment clarified that there is a difference between seed that
has been certified according to AOSCA standards (or an international
equivalent standard) for varietal purity, and seed that has been tested
for THC or other compounds. It asserted that some State programs have
confused the terminology and urged USDA to clarify the difference and
promote use of certified seed for varietal purity. The comment said the
hemp industry has access to numerous proven varieties and that plant
breeders are making strides to develop more varieties with specific
characteristics.
Numerous other comments reinforced the need for seed certification
programs that ensure hemp seed meets high standards for proper
labeling, reliable germination rates, purity, and the ability to
produce healthy plants. Some comments supported seed certification
under State or Tribal programs, claiming such localized programs have
proven successful in areas where they've been developed and used, and
saying that such programs promote crop predictability and reduce
uncertainty for farmers. One comment asserted that not only seed, but
clone certification is a must, to ensure that growers are getting what
they think they are when they purchase clones from nurseries. Some
comments asserted confidence in certified seed could be extended to
crop insurers, who could provide coverage at prices that reflect
reduced risk. Some comments suggested growers using seed certified
under a Federal certification program should be indemnified against
legal liability or financial losses related to production of hemp that
tests higher than the acceptable THC level. Some comments suggested
States and Tribes that adopt seed certification programs
[[Page 5626]]
for cultivars reliably producing compliant plants should be authorized
to exempt such cultivars from hemp sampling and testing requirements or
to employ random, risk-based sampling schemes supported by data about
those cultivars.
AMS Responses: AMS is not establishing a seed certification program
for hemp. The IFR explained USDA's decision to not establish a seed
certification program was due to a lack of accurate data and the
advanced technology necessary to develop such a program. The term
``certification,'' as used here, means tested or verified and does not
necessarily mean certified for seed varietal purity or genetics. AMS
understands that some seed certification-related studies are already
under way in different locations and that results of these studies are
helpful in production risk mitigation. AMS recommends the use of hemp
seed from varieties that have undergone a variety review, following the
process outlined in the Federal Seed Act and associated regulations, (7
U.S.C. 1551-1611 and 7 CFR part 201), and produced according to AOSCA
standards. These types of seed have been screened and tested for purity
and are properly labeled. This final rule maintains flexibility for
stakeholders to continue with trials of seed varietals and does not
prohibit the use of any hemp varietals by industry. Updating the
varieties list is a State and Tribal issue, as they developed them.
This final rule does not address seed certification. However, USDA will
consider such a program in the future if enough information is
available. If there is sufficient data to support a program, USDA will
explore adopting one through rulemaking under the APA.
Separately from this hemp production regulation, AMS administers
the Plant Variety Protection Office (PVPO). This office actively
accepts applications of seed-propagated hemp for plant variety
protection. Under the U.S. Plant Variety Protection Act, PVPO examines
new applications and grants certificates that protect varieties for 20
years (25 years for vines and trees). PVPO provides intellectual
property protection to breeders of new varieties of seeds and tubers.
Certificate owners have rights to exclude others from marketing and
selling their varieties, manage the use of their varieties by other
breeders, and enjoy legal protection of their work.
Regulations for Different Operations
The 2018 Farm Bill requires any producer growing hemp to be
licensed either by their applicable State or Tribal authority or USDA.
The IFR further required that an authorized sampling agent collect
samples from floral material for THC concentration testing in order to
determine compliance with the Federally established THC threshold. Some
operations growing hemp do not grow to the stage where flower material
is present and as such cannot test the floral material.
Clones and Cloning: Comments noted there are a significant number
of grower operations that cultivate and produce hemp plants year-round.
Some of these operations grow hemp varietals and maintain mother clones
and/or grow plants for clonal propagation or tissue culture propagation
purposes. Comments explained that hemp varietals grown in these types
of production systems do not usually reach full maturity. According to
comments, before achieving the floral stage of development, many of
these hemp varietals are sold and enter the stream of commerce as
starter plants that other licensed hemp growers may transplant to a
field or greenhouse to be raised to full maturity and harvest. Comments
questioned how immature or juvenile hemp plants with no floral material
to test can demonstrate regulatory compliance under the IFR.
Microgreens: Comments raised similar concerns about hemp raised and
marketed as microgreens or other types of immature plants intended for
human consumption, noting that these plants cannot be tested for
regulatory compliance because they have no floral material to test.
Comments encouraged USDA to develop a regulatory process in which THC
concentration testing may occur for immature, non-flowering hemp
varietals so that operations like those producing clones or microgreens
can support the development of the hemp industry.
One comment representing a hemp cultivation and distribution
corporation in several states provided a pre harvest test on a
microgreen variety grown in two different States. One State test
reported 0.17 percent total cannabinoids and the other test reported
0.0193 percent total cannabinoids. Based on these tests, commenter
indicated that hemp leaf greens/microgreens and related crops are not
in danger of excess THC.
Hemp Research: Numerous comments stated the need for a separate
regulatory scheme to support hemp research. Comments explained that the
plant breeding process by its nature requires breeders to bring
multiple varieties of plants to maturity in order to evaluate their
characteristics and potential use in ongoing hybridization projects.
They said, for example, that plants with desirable characteristics such
as frost and drought tolerance or pest resistance must be identified
and preserved, while plants with unwanted genetic traits or diseases
must be separated and destroyed in order to stabilize the genetics for
THC expression and other desirable traits and understand how
environmental factors, disease, and insect pressure affect the
expression of those traits. According to comments, the THC
concentration in such plants could exceed the acceptable THC level in
the IFR and plant breeders could find themselves in violation of the
law. As well, they explained that the IFR's disposal requirement could
force breeders to destroy valuable plant material and waste years of
work, as well as funding.
Other comments asked USDA to support research into hemp pollination
and drift. Comments reported industry concern that cross pollination
could reduce the value of neighboring CBD flower crops. They asked USDA
to focus on grain producing geographic areas and varieties to provide
the science to support large acreage growers.
Comments explained that the IFR's THC threshold of 0.3 percent
reduces the incentive to conduct hemp variety research because of the
likelihood that many plants will exceed that threshold. For example,
comments suggested the THC limit for hemp plants in licensed breeding
programs could be raised to 0.6 percent or 1.0 percent or higher. They
suggested breeders be allowed to raise plants to maturity, collect data
and save seed for further research, and be required to destroy
noncompliant plant material at the end of the growing season. Other
comments suggested that breeders and researchers should not have to
wait for hemp plants to flower and undergo testing before they can
remove and destroy those plants with undesirable traits.
Comments asserted that hemp strains used in genetic studies
authorized by the 2014 Farm Bill and compliant with other program
regulations may now be in jeopardy due to the uniform application of
the IFR's 0.3 percent THC threshold and plant disposal requirements.
They noted how a regulation that requires the disposal of what was
previously compliant hemp will undermine the efforts and millions of
dollars invested by farmers and researchers. Other comments indicated
that not having the ability to replicate certain genetic traits from a
plant that is noncompliant can slow the development of industry.
Comments from and about university research programs suggested that
USDA make land grant universities eligible for special research carve-
outs or regulatory
[[Page 5627]]
exemptions to allow them to continue research efforts. Other comments
suggested USDA define criteria under which researchers and other plant
breeders could be eligible for special research program exemptions.
They suggested USDA develop criteria for certification or qualification
of hemp researches and breeders, and some suggested those meeting
specified criteria could be exempt from the IFR's crop destruction and
reporting requirements, provided they adhere to other restrictions,
such as prohibiting research material from entering the chain of
commerce, disposing of non-compliant plant material, and limiting plot
size. Some commenters noted that without such allowances their
university administrators would not allow them to continue research
with any form of cannabis, including hemp, due to concerns about
Federal grant disqualification.
One commenter requested an exemption for Tribal research facilities
so that they will not have to destroy all non-compliant plants.
Comments noted that USDA's National Institute of Food and
Agriculture had not issued requests for applications on hemp research
and that hemp was not listed for funding under the Specialty Crop
Research Initiative. Comments suggested more agronomic research is
needed to address current gaps in knowledge related to hemp production
and management and to standardize seed.
AMS response: Due to the variability in immature plants across
producers, States, and Tribes, and the lack of consistency across
varietals, USDA is unable to establish or standardize an approach to
dealing with immature plants for USDA licensees. However, AMS
acknowledges operations that grow hemp for certain purposes that do not
bring plants to their flowering stage like clones and microgreens, may
not need to meet the same sampling and testing requirements as
operations that grow flowering hemp. The final rule provides States and
Tribes the flexibility to consider performance-based sampling protocols
to address these concerns. As allowed under the AMA, States and Indian
Tribes can be more restrictive and may impose sampling and testing
requirements on these producers.
USDA also acknowledges that research institutions face special
circumstances when conducting hemp research. Accordingly, this rule
provides sampling and testing flexibility to these institutions and
producers working with them to conduct hemp research under the USDA
plan. Producers that produce hemp for research must obtain a USDA
license or a State or Tribal license. However, the hemp that is
produced for research is not subject to the same sampling requirements
or the requirements pertaining to non-compliant plants, provided that
the producer adopts and carries out an alternative sampling method that
has the potential to ensure, at a confidence level of 95 percent, that
the cannabis plant species Cannabis sativa L. that will be subject to
this alternative method will not test above the acceptable hemp THC
level. USDA licensees will need to submit an alternative sampling
method to USDA for approval and shall ensure the disposal of all non-
compliant plants. USDA licensees shall also comply with the reporting
requirements including reporting disposal of non-compliant plants.
AMS views this flexibility as necessary to help support research
and development as it relates to hemp production by industry,
particularly in its infancy. This decision allows these types of
research facilities and institutions to oversee the study of hemp
plants through trialing and genetics research. Over time, the
flexibility provided by this final rule will help to stabilize industry
by providing greater understanding of hemp genetics and how certain
varietals respond differently to growing conditions in various
geographic locations. All producers are expected to benefit from such
knowledge as information about more stable and consistently reliable
hemp varietals becomes available. Any non-compliant plants produced by
research institutions as a result of research and development will
still need to be disposed and disposal will need to be verified with
documentation. Research institutions that handle ``hot'' hemp must
follow CSA requirements for handling marijuana.
Sampling Agents
This final rule reiterates that samples of hemp collected for
purposes of testing THC must be collected by sampling agents, or by
Federal, State, Tribal or local law enforcement agents authorized by
USDA to collect samples. Requirements and training materials for
sampling agents are provided on USDA's website.
Third-party Sampling Agents: Some comments supported the use of
third-party sampling agents to help offset the cyclical demand for hemp
sample collection and to ensure integrity in the sampling process.
Comments noted that some State agriculture departments have relied on
in-house personnel to perform sampling activities and that these States
did not use or require third-party sampling agents during piloting.
One comment reported use of third-party certified samplers for the
2020 season, and as of the date of their comment, had employed 74
certified sampling agents. The commenter said the State recommends
producers make appointments with sampling agents 30 days in advance
prior to intended harvests, and that they had not received any feedback
regarding unavailability of sampling agents based on the 15-day window.
The comment went on to report that the State had received numerous
anecdotes of next-day availability for sampling, which the comment
suggested would not be possible without the use of third-party sampling
agents.
Resources: Several commenters worried that there would be
insufficient numbers of appropriately trained, USDA-approved sampling
agents available during harvest periods to ensure that all crops could
be sampled, tested, and harvested within the 15-day window specified in
the IFR. They asserted that sampling backlogs and delayed testing and
harvesting would cause crops to mature beyond the acceptable hemp THC
content concentration, resulting in crop disposals and financial losses
for farmers. Several comments said producers in rural and remote
mountainous areas would be particularly impacted, since sampling agent
travel into those areas would require extra time and expense.
Comments described how some States developed sustainable hemp
oversight programs using risk-based sampling methodology to support
regulatory monitoring of hemp growers. They asserted these same States
would find it difficult to meet the IFR's sampling requirement because
of a limited budget to hire and train additional personnel for sampling
all hemp production. Comments reported having to make appointments for
sample collection a week in advance under risk-based sampling plans and
predicted it would be even harder to arrange for sample collection on a
timely basis under the IFR's requirement that all hemp lots be sampled
and tested.
Commenters presented two proposals to alleviate this strain--
allowing producers to collect their own samples and reducing the volume
of farms and plants from which samples are collected.
Some commenters requested that USDA compile a publicly available
national list of sampling agents.
[[Page 5628]]
Sampling Agent Training: Comments highlighted the importance of
providing robust training for sampling agents and recommended
subsequent annual, documented refresher training be required. Some
comments recommended USDA develop and implement a sampling agent
certification scheme, while others suggested States and Tribes retain
the authority to develop sampling agent training. Other comments
suggested including a sampling agent training application on the USDA
website.
Other Comments on Sampling Agents: Other comments objected to the
IFR's provision that sampling agents be given unlimited access to all
areas listed in the producer's license. Comments claimed that this
provision, in addition to the fact that default sampling agents may
also be law enforcement representatives, seems to associate the now
legal hemp industry with potential illegal activity. Comments stated
further that while State, Tribal, and USDA personnel may require such
access for audits or other purposes, broad access is not necessary for
sampling hemp, and that sampling access should be limited to cannabis
plant material being cultivated as hemp.
Other commenters suggested that sampling agents should be
agricultural specialists rather than law enforcement specialists in
order to alleviate possible tension between Indian Tribes and law
enforcement, and would ensure that the sampling agents have an
understanding of the agricultural product they are working with.
AMS response: AMS agrees with the many commenters that sampling
agent training should be enhanced. Standardized training for sampling
agents will help achieve regulatory consistency. As such, AMS will
provide training documents for sampling concurrently with publication
of this final rule. The revised sampling agent training will establish
uniform and standardized criteria, including sampling processes and
procedures, to ensure the sampling agents understand regulatory
provisions of this final rule and the appropriate processes associated
with sampling activities. This will help ensure that sampling done by
different agents will be conducted similarly. AMS anticipates this will
minimize variances in sampling practices that may affect the samples
and ultimately the test results.
Training documents will explain how sampling agents can meet the
sampling requirements of this final rule. States and Indian Tribes with
an approved plan may require the sampling agents used by their licensed
producers to take the USDA training, or they may develop their own
custom training. This decision does not change the requirement that
designated agents collect samples. We are retaining the requirement
from the IFR that the use of third-party agents is acceptable.
Requiring sample collection by trained agents ensures that samples are
collected consistently throughout the industry and no conflict of
interest exists between the sampler and grower.
Further, AMS has addressed commenters' concerns about adequate
resources by allowing for States and Indian Tribes to design a sampling
plan in accordance with the AMA and this final rule that suits their
needs and resources. Additional discussion of sampling methodologies
and flexibilities is included elsewhere in this final rule.
AMS agrees with the concerns that sampling agents be given
unlimited access to all areas listed in the producer's license and is
clarifying that sampling agents need access only to areas where the
hemp is grown and stored so they can perform their sampling work.
AMS agrees with comments that allowing third-party individuals to
become certified hemp sampling agents creates jobs, gives producers
greater flexibility during the harvest season, and allows the States
and Tribes to reallocate resources. The final rule does not limit
sampling agents to law enforcement officers and does not prevent
agricultural specialists operating as sampling agents. Because States
and Indian Tribes with approved plans may approve their own sampling
agents, USDA encourages States and Tribes to maintain their own lists
of sampling agents.
Sampling Methodology
AMS posted supplemental Sampling Guidelines for Hemp Growing
Facilities on its website. The guidelines describe sampling procedures,
including the number of cuttings to take for sampling each lot and how
to pace a hemp field when sampling. A few comments addressed the
Sampling Guidelines and recommended alternative sample volumes and
field sampling patterns.
End-use/risk-based sampling: Comments asserted that hemp sampling
requirements should differ based on the crop's end-use, primarily
whether the crop is used for grain and fiber production or for
cannabinoid extraction. They contended that the IFR requirement to
sample every hemp lot, regardless of the crop's end-use, is expensive
and burdensome for States, Indian Tribes, and individual growers.
Comments generally discouraged requiring sampling and testing every lot
for THC since THC concentration is significantly lower in male plants
and grain/fiber varietals. Comments from State agriculture departments
that administer pilot programs under the 2014 Farm Bill also explained
how risk-based sampling requirements under their programs function.
Comments emphasized that a ``one-size-fits-all'' regulation is
inappropriate and discourages innovation as there are different risk-
profiles for hemp based on its end-use.
Comments maintained that grain and fiber varietals are less likely
than cannabinoid crops to exceed the THC threshold and argued that
assessing all hemp by the same standard may result in strained
oversight resources and inefficiencies. One comment asserted that THC
concentration in varietals grown for grain is reduced dramatically by
the production of seeds in the flower and, therefore, hemp grown for
grain is at lower risk of exceeding the THC limit. Comments also noted
that the flower parts, where a majority of the THC is concentrated, do
not fairly represent the THC content of the entire plant, which is used
in biomass and fiber production.
One State agriculture department noted that many of the seed and
fiber varietals being grown in their State were originally bred in
Canada and have been selected for low THC content as part of Canada's
hemp program for many years. Several trade association comments noted
that hemp grain/seed is not a source of cannabinoids, and that grain
and fiber varietals are largely developed from certified, pedigreed
seed that meets all THC testing standards. Commenters contrasted that
with hemp crops grown for cannabinoids, and that the latter show higher
phenotypic variability and lack of uniformity in the field because they
have received less focus in breeding programs. One comment stated that
hemp varietals grown for cannabinoid production often have questionable
origins and are at a greater risk of producing higher THC than
varieties grown for grain or fiber. Another comment claimed there are
currently no certified varieties of hemp for CBD production.
Many comments agreed that hemp grown for cannabinoid production is
more likely to exceed acceptable THC limits. Data from 2019 submitted
with a comment showed that 13 percent of hemp samples tested exceeded
0.3 percent THC, and all were CBD varietals. The comment further
recommends that certified seed varieties should be sampled and tested
from a random selection of hemp grain and
[[Page 5629]]
fiber fields 30 days prior to harvest. For uncertified varieties, it
recommends requiring a post-harvest test, as well as a pre-harvest test
of a random selection of fields within 30 days of harvest. According to
comments, those hemp crops being grown for cannabinoids should be
subject to higher scrutiny and more frequent testing.
Another commenter cited data from the Midwestern Hemp Database \18\
showing that many publicly available varieties are exhibiting a linear
(or curvilinear) relationship between Total CBD (%) and Total THC (%).
Given this presumed relationship, Total CBD percentages are often not
able to exceed 8 percent without exceeding the regulatory threshold of
0.3 percent THC. The commenter said these moderate levels of CBD
production can have significant impacts on profitability as growers and
therefore a whole plant testing methodology would help to mitigate this
linear relationship.
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\18\ https://farmdoc.illinois.edu/field-crop-production/hemp/midwestern-hemp-database-a-new-tool-for-hemp-growers.html.
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Comments identified States and other institutions where they think
risk-based oversight modeling works to ensure hemp is at 0.3%
acceptable hemp THC level. For example, the Kentucky Department of
Agriculture publishes a ``Varieties List'' to track THC content across
hemp varieties. Comments characterized this as a useful tool for hemp
farmers when planning production cycles and selecting hemp varietals.
Several comments also described how, at the State level, other measures
support risk-based oversight, like randomized sampling crops of a
percentage of the total grower population or the use of risk criteria
to identify ``high risk'' growers. Commenters credited these types of
practices and activities with allowing states to efficiently oversee
hemp production under pilot programs. Other comments described how
financial institutions routinely incorporate risk-based modeling into
the risk assessment of lending decisions, and that similar modeling
should be adopted by USDA for sampling and testing.
Comments argued that subjecting all varietals to the same
regulatory requirements under the final rule will compound logistical
challenges to oversight bodies, strain resources, and increase costs
for low-risk farmers. They said testing based on hemp's end-use created
a more flexible approach to oversight while benefiting the farmer.
Two state department of agriculture comments supported end use or
risk-based sampling methods in order to account for producers using
certified seed, producing hemp for industrial use purposes, fiber,
grain, seed, extraction of biomass, and indoor producers growing plants
only in vegetative state for research or resale that pose a low risk
for detectable THC content.
Several other comments suggested ways USDA could incorporate risk-
based sampling into the domestic hemp production program. Comments
recommended USDA evaluate and consider allowing greater regulatory
flexibility for States and Tribes to develop and use risk-based
modeling to guide their sampling and testing activities. According to
comments, this approach would help offset the anticipated strain on
resources during peak sampling that would otherwise result under the
IFR requirements.
Two State agriculture departments recommended that crops produced
from AOSCA-certified seed, which they said currently only include grain
and fiber varietals, be considered low-risk for testing and compliance
purposes. Comments said that as more CBD hemp varietals are developed
and certified, they could also be subject to less stringent testing
protocols.
A few comments suggested the adoption of a random risk-based
sampling and testing scheme to reduce grower costs and relieve pressure
on approved labs by reducing the number and volume of required tests.
One comment indicated State hemp regulators have successfully developed
sampling requirements for end-use that ensure adherence to State and
Federal regulations, while allowing for flexibilities around State
resources. Other comments sought requirements establishing a minimum
number of cuttings per lot (e.g., ``5'' cuttings per lot regardless of
size.) For example, one comment suggested that when sampling lots of
less than 1 acre, taking cuttings of one plant will not allow for a
representative sample, so a minimum of 5 plants be identified for
cuttings. Another comment said that the sampling requirements in the
IFR, as applied to a 170-acre field, could require the sampling of as
many as 110 plants from that field which would be impossible for a
state department of agriculture to meet. As an alternative, USDA might
provide a fixed sliding scale (for example, a lot of less than 10 acres
requires 5 plants; a lot between 10 acres and 20 acres requires 6
plants; and so on) rather than leaving those calculations to each
state. Alternatively, another comment explained how their state
sampling protocol currently utilizes the parameters of a minimum of 6
cuttings per lot or acre, whichever is smaller, with the option for
producers to increase the quantity of cuttings collected as they see
fit (up to 150 cuttings per lot). Another comment described how
contracted labs for their state have requested at least 40 grams of wet
material and up to 60 grams if the licensee is also needing additional
testing such as heavy metals, pesticides and mycotoxins.
One comment reported the results of a 2019 controlled study where
the top 12 inches of the plant and the top 2 inches of flowering
material were collected from each of 83 plants, for a total of 166
samples. The samples were tested using gas chromatography with flame
ionization detection. Test results showing total delta-9 THC of the 2-
inch cuttings were, on average, 0.0273 percent higher than results for
the 12-inch cuttings. The comment interpreted the results to suggest
that including vegetation from the entire plant yields lower THC
results, and that all parts of hemp plants should be sampled because
producers generally harvest the entire plant.
One comment reported that their State requires samples for any size
lot to include 30 buds (subsamples) to insure there is large enough
volume of material to provide for adequate sample testing. Another
comment reported that State staff are directed to look at a cultivar
and evaluate it for uniformity with respect to maturation, height,
color, and basic plant architecture. According to the comment,
uniformity within a cultivar results in fewer plants sampled than a
cultivar exhibiting greater phenotypic diversity for the same acreage.
The comment supported providing States with authority to establish
sampling protocols, given the significant variation in plant counts
between fields (on a per acre basis) and phenotypic diversity within
and between cultivars. The comment also recommended that AMS provide
guidance on a recommended number of plants to be sampled per unit area,
including the plant density for each sample number recommendation.
One comment advocated revisions to USDA's sampling guidelines. The
commenter said the State has had to deviate from USDA's sampling table,
specifically for smaller lots. According to the comment, taking a
sample from one plant does not provide enough material for lab testing,
and the State has had to bear the cost of taking a second sample. The
comment mentioned that some of the State-contracted labs have requested
at least 40 grams of wet material and up to 60 grams, if the licensee
is also requesting additional testing, such as for heavy
[[Page 5630]]
metals, pesticides, and mycotoxins. The comment also explained that to
keep from delivering excess material from large lots to labs,
inspectors take the required number of cuttings, then homogenize the
sample, keep the required 40 to 60 grams, and leave the remaining
sample material in the field. The comment supported a sampling protocol
that would provide adequate testing material without unnecessarily
overcutting plants material.
One comment reported results of a poll they conducted among States
after the end of the 2018 growing season. According to the comment,
three States--New York, Pennsylvania, and Minnesota--reported they had
analyzed the THC content in microgreens, and none were found to be
above 0.3 percent total THC.
One comment reported that their State has tested every hemp lot
produced in Minnesota in the past five years, and that hemp grown for
grain and fiber has never tested above the 0.3 percent total THC limit.
According to the comment, varieties grown in Minnesota are certified
varieties found either on the Health Canada List of Approved Cultivars
or the European Union's Organization for Economic Co-operation and
Development List of Varieties Eligible for Seed Certification.
One comment reported their State has implemented a risk-based
sampling frequency schedule, under authorities provided for in the 2014
Farm Bill, using end-use and certified seed as guidance. According to
the comment, official total THC results collected from regulatory
samples and formal research samples showed that hemp grown from
certified seed have a low risk of testing above 0.3 percent.
Additionally, the grain or stalk components of hemp have zero to
negligible levels of total THC. The comment recognizes that more
research is needed in this area but is confident that the utilization
of hemp variety categories to determine the department's sampling
frequency has been successful to date.
AMS response: AMS agrees that States and Indian Tribes need more
flexibility in developing sampling methodologies. For States and Indian
Tribes with primary regulatory authority, USDA is altering the sampling
requirements in this final rule to allow performance-based sampling
methodologies. Information submitted by States that participated in the
2014 pilot program show various ways these States are already using
performance-based sampling. Some States are using a list of varieties
that work in their geographical area while others rely on evaluation on
what they consider high risk producers. USDA finds the data submitted
by commenters to be reliable because these States have been growing
hemp since the 2014 pilot program started and they have sufficient data
to develop their sampling plans. AMS agrees with commenters that the
performance-based concept is the same method that financial
institutions use. Further, performance-based programs are also used by
other scientific and Federal agencies such as USDA's Food Safety and
Inspection Service and FDA.
AMS finds that it makes sense to encourage States and Indian Tribes
to consider performance-based alternatives when developing sampling
plans. The final rule provides the standard; however, States and Indian
Tribes have the flexibility to determine how to achieve that standard
tailored to their specific needs.
The sampling requirements for State and Tribal plans allow for
States and Indian Tribes to develop unique sampling protocols for hemp
licensees under their jurisdiction. State and Tribal plans must include
a procedure for accurate and effective sampling of hemp that meets the
requirements of the final rule. The method used for sampling must be
sufficient at a confidence level of 95 percent that no more than one
percent of the plants in each lot would exceed the acceptable hemp THC
level. Alternatively, States and Indian Tribes may design a sampling
method that is performance-based that ensures, at a confidence level of
95 percent, that plants will not test above the acceptable hemp THC
level. This plan must be part of the State or Tribal plan. A
performance-based method may consider: (1) A seed certification process
or process that identifies varieties that have consistently
demonstrated to result in compliant hemp plants in that State or
territory of the Indian Tribe; (2) whether a producer is conducting
research at an institution of higher learning or that is funded by a
Federal, State, or Tribal government; (3) whether a producer has
consistently produced compliant hemp plants over several years or
several seasons; and other similar factors. USDA believes this will
provide needed flexibility to States and Indian Tribes to develop
logical and enforceable sampling requirements that take into
consideration their unique circumstances. AMS will still require States
and Indian Tribes to submit their individual sampling requirements for
review as a component of the plan approval process. Sampling protocols
submitted by States and Indian Tribes must comply with the thresholds
established by the 2018 Farm Bill and this final rule. If performance-
based sampling requirements are not included in a State or Tribal plan,
every lot, and thereby every producer must be sampled and tested.
When evaluating sampling protocols submitted by States and Indian
Tribes, USDA will take into consideration whether the performance-based
factors the State or Indian Tribe used have the potential to ensure
compliance at a 95 percent confidence level. USDA licensed producers
are required to comply with the sampling requirements in this final
rule. Additional guidance on sampling for USDA licensees or States and
Indian Tribes that decide to use these guidelines is available on the
USDA website at https://www.ams.usda.gov/rules-regulations/hemp/information-sampling. USDA may develop a performance-based sampling in
the future if data is available and if it deems appropriate. Separate
rulemaking and comment process will be necessary to establish a
performance-based sampling plan by USDA.
USDA plans to audit State and Tribal activities to assess program
compliance with all Federal requirements, which includes review of the
performance-based sampling implemented by States and Indian Tribes.
Sampling Guidance: A comment noted that although the sampling
protocol was issued as a guideline, it appears to be binding with
regard to how hemp must be sampled. The comment said AMS should clarify
that there may be other acceptable sampling procedures that would meet
the IFR's sampling requirement. The comment explained further that some
States operating hemp programs under the 2014 Farm Bill have
established detailed hemp sampling protocols that producers are used to
and should be allowed to continue.
Another comment appreciated the IFR's provision that the AMS
Sampling Guidelines may need continual updating and refinement as
industry, academia, and government discover new evidence, science,
products, and innovations.
A comment described the hemp field sampling plan they adopted from
Florida's nematode sampling plan. The plan recognizes that nematodes
are unlikely to be evenly distributed throughout an orchard or field,
which would also allow for accurate detection of THC fluctuation within
a hemp field. The comment said Florida's sampling plan is accepted by
every State and country to whom they send citrus plant material that
has been screened for nematodes and recommended AMS
[[Page 5631]]
revise the hemp Sampling Guidelines to incorporate Florida's sampling
plan.
A comment said Kentucky requires cuttings from five plants per lot,
believing this standard provides a reasonably representative sampling
of the plants in each lot. It opposed the sliding scale in AMS's
Sampling Guidelines, saying the sliding-scale calculation relies upon a
decades-old pesticide residue sampling regime that may or may not be
appropriate for calculating confidence levels in a hemp plant's THC
levels. The comment asserted the sliding scale formula, which depends
on a variable factor based on historical data, is likely to create
state-to-state variations in the number of samples that must be
collected, and would require States with historically lower rates of
non-compliant THC test results to take more samples per lot than those
States with historically higher rates of non-compliance, which the
comment found to be illogical. The comment explained that applying the
Sampling Guidelines' sliding scale calculation to a 170-acre field
could require the sampling of as many as 110 plants from that field. It
went on to say that sampling a single field under that scenario would
overburden available sampling and laboratory staff, make transporting
sample material difficult, and make grinding sample material an
impossible workload. The comment recommended AMS specify a single
number of plants to be sampled from every lot, regardless of the lot's
size, or publish a fixed sliding scale for industry-wide use, rather
than leaving those calculations to each State. This comment was
supported by several state departments of agriculture.
A comment noted the importance of moisture content consistency in
compliance sampling and recommends 8-12 percent moisture content
standardization. They also noted the need for best practices to be
identified for drying sample material.
Several comments said USDA's sliding scale sampling protocol
results in too little a sample for small acreages and too large a
sample for large acreages. Comments asserted, for example, that one
cutting for four acres or less would not be suitable to collect a
representative sample and could put small acreage farmers at a higher
risk of being violative or not might be sufficient to capture
uncertainty related to population variability in a newly established
crop. Another comment said that a true representative sample needs to
entail multiple subsamples collected spatially across a field and
pooled into an average sample. Further, according to the comment, since
cannabinoids tend to increase along the height of the plant, floral
material should be sampled at random heights from plants rather than
all from the tops of plants to be representative.
Another comment recommended revisions to the Sampling Guidelines to
provide that sampling agents should sample fields in a zig-zag pattern.
The comment further recommended that AMS revise the Sampling Guidelines
to provide that three cuttings should be taken from every plant
sampled, and that the three cuttings should be taken of floral, stem,
leaf and stalk material at three different points on the plant. It
argued that floral material makes up only 25 to 30 percent of hemp
plants and that, to be truly representative of the sampled plant, the
sample should consist of cuttings of all plant materials from
throughout the plant.
One comment recommended requiring that samples consist of a minimum
of 4 ounces of material to provide an adequate amount for testing.
Another comment suggested USDA research and review multiple sampling
protocols and select the best among them.
AMS response: AMS agrees that establishing clear and standardized
Sampling Guidelines is important for all hemp producers and States and
Indian Tribes with primary regulatory authority over hemp. AMS issued
Sampling Guidelines and is updating that guidance to reflect the
changes from the IFR to this final rule. States and Indian Tribes with
USDA-approved hemp production plans may develop their own sampling
procedures that take into account regional and other differences and
are performance-based, so long as those procedures meet the
requirements in the regulations at Sec. 990.3. The entirety of the
State or Tribal sampling plan, including any guidelines, must be
included in the State or Tribal plan submitted to USDA for approval.
When developing such plans the State or Indian Tribe must follow the
requirements of this final rule that relate to where the cutting takes
place including only flower material, and the number of inches
necessary for sampling. Specific to sample size or weight of a cutting,
AMS does not agree that establishing a specific volume is prudent given
the variances in flower size and densities, and different scales of
hemp production. It would be difficult to consistently sample at an
exact weight of plant material across the spectrum of producers and
therefore is not included in this final rule. Rather, AMS specifies a
length (approximately five to eight inches) from the ``main stem''
(that includes the leaves and flowers), ``terminal bud'' (that occurs
at the end of a stem), or ``central cola'' (cut stem that could develop
into a bud) of the flowering top of the plant.
This is considered appropriate and fair to balance the collection
of sufficient plant material necessary for compliance laboratory
testing while avoiding the need to cut excessive and unreasonable
amounts of plant material.
Further, AMS determined this final rule must provide some
additional degree of flexibility for States and Indian Tribes in the
development of their sampling plans, which is why as an alternative,
this final rule allows for performance-based sampling methodologies in
State and Tribal plans.
Flexibilities afforded to States and Indian Tribes developing their
own hemp production plans will allow them to incorporate best
practices, as those change and develop over time. For example, States
and Indian Tribes can adapt field-walking patterns to various sized and
shaped hemp grower operations. AMS believes that a national standard
would be difficult to consistently apply given the various grower
operations and that standard ``zig-zag,'' or letters ``M'' or ``Z''
walk patterns may not be feasible for sample collection of micro-
acreage producers, very large scale producers or those with polygonal
hemp lots.
As an alternative option, AMS has updated the Sampling Guidelines
and Protocols in conjunction with the publication of this final rule.
This resource document is available online and offers guidance States
or Indian Tribes can adopt and incorporate into their own USDA-approved
sampling procedures.
Flower Versus Whole Plant Sampling
The IFR requires the collection of samples from the flower material
of hemp plants for laboratory testing.
Comments: Several comments expressed support for sampling only hemp
flowers, as provided in the IFR, although many recommended changes to
the overall flower material sampling requirements. Those
recommendations and commenters' explanations for them are addressed in
another section of the comment analysis. Numerous comments opposed the
IFR's floral material sampling requirement, preferring instead
composite sampling of the flowers, stems, stalks, and seeds, and
asserting such samples would be more truly representative of the entire
plant and lot. Numerous comments agreed that cannabinoid concentrations
are higher in the flower than in other parts of the plant, and many
comments
[[Page 5632]]
argued that sampling only floral material would cause more samples to
inappropriately and unfairly test ``hot'' and lead to unwarranted and
costly crop disposals.
Several comments said that sampling only the flowering material of
the hemp plant is inconsistent with the definition of industrial hemp,
as amended by the 2018 Farm Bill, which refers to the whole hemp plant.
Comments asserted that the statute did not limit sampling to floral
material and challenged USDA's interpretation of the statutory sampling
requirement. As well, comments argued that requiring sampling of only
flowering material could lead to legal challenges from producers who
would be forced to destroy hemp that may be statutorily compliant, but
not compliant with the IFR. They recommended that the regulations
provide for sampling the whole plant and that USDA define the term
``whole plant'' to include the flower, stalk, and leaves.
Some comments stated that sampling only flower material ignores the
hemp grown for seed and stalk end-uses, and not for cannabinoids.
Comments claimed that sampling and testing only flowering material
would limit industry diversification in terms of producing hemp for
biomass intended for uses other than THC production. To address this,
several recommendations for revisions to the IFR's sampling
requirements were offered. Some comments recommended taking larger
samples from prescribed parts of hemp plants that would include other
than flowering material. For example, both State departments of
agriculture and Indian Tribes recommended taking branch samples from
two or more specified parts of plants that would include flowers,
stems, stalks, and seeds, and proposed a range of sample lengths they
considered appropriate, from 4 to 18 inches. Some recommended taking
samples of the lower part of branches as well as flowering tips from
the same plant. Several comments urged USDA to adopt risk-based
sampling requirements that would better align with the intended end-use
of hemp crops, like grain and fiber. Other comments recommended
revising the IFR to allow States and Indian Tribes to design sampling
requirements to meet the particular needs of producers in their
jurisdictions, like producers who are well experienced with growing
hemp and understand the potential to grow a non-compliant crop.
Commenters expressed the widely shared view that cuttings for hemp
samples must come from various locations on the plant, not just the top
third as indicated by the Sampling Guidelines. They explained that
marketable hemp product comes from a composite of the entire plant, not
just the top, and asserted that flower material samples should likewise
come from the entire plant to ensure the sample accurately reflects the
lot from which it is taken. Comments also voiced the need for greater
regulatory clarity on the size of the floral cuttings due to concerns
that no regulatory requirements address floral collection by authorized
sampling agents, and variances in types of materials collected may
affect test results.
Cannabinoid Concentrations: Comments described phytochemical
characteristics of Cannabis sativa L and argued that samples taken from
only one part of the plant are not representative of the whole plant.
Some comments contended that flowers at the top of the plant have
higher concentrations of THC and other cannabinoids--by as much as 30
percent, according to some--than flowers elsewhere on the plant. One
comment cited a study \19\ that found that top-only sampling, as
prescribed in many State testing programs, leads to an overestimation
of THC content by nearly 37 percent. The study stated that to better
represent total crop THC levels, samples should be taken from the top,
middle, and bottom of plants in equal quantities. Commenters asserted
that sampling flowers from only the top of the plant could lead to
incorrect conclusions about the lot's compliance and lead to
inappropriate and costly lot disposals.
---------------------------------------------------------------------------
\19\ ``THC Distribution in Field Grown Hemp Prior to Harvest,''
J. Scott Lowman, Jack He, Mike Clark, and Mark Gignac; The Institute
for Advanced Learning and Research (IALR), Danville, Virginia.
---------------------------------------------------------------------------
Other comments contended that THC concentrations are not
necessarily higher at the top of the hemp plant. One comment used data
to show that the distribution of THC concentrations throughout hemp
plants is not consistent between varieties. It cited a 2019 comparison
study in which 4-inch cuttings of floral material from two hemp
varieties were taken from the top, middle, and bottom sections of
plants. In one variety, total THC was highest in samples taken at the
top, and lowest in samples taken from the bottom of plants. In the
other variety, total THC varied little between samples from plant top,
middle, and bottom positions. The comment said the data refutes the
belief that THC levels are highest at the top of the plant and supports
sampling from all parts of the plant to obtain an accurate
representation of each lot's composite marketable hemp product.
Sampling technique: Some comments cautioned that inconsistent
potency measurements may be the result of divergent sampling approaches
and recommended that USDA provide regulatory clarity as to the proper
sampling process.
A comment encouraged USDA to establish clear numeric designations
of how much floral material is taken from each plant. Comments varied
in their suggestions on sample cut including: 12 inches per plant; cuts
from the top and bottom 18 inches of a terminal branch of the plant to
achieve a more representative sample; cutting from the top twenty
centimeters from the main stem of the female plant; eight to ten inches
of the plant's primary stem; whole plant sampling whereby the top 1/
3rd, middle 1/3rd and bottom 1/3rd are each sampled; and to ground the
whole plant--not only the top 1/3rd--as that is not representative of
the delta-9 THC level of the plant.
AMS response: The IFR required the collection of samples from the
flower material of hemp plants for laboratory testing. Following the
publication of the IFR, AMS made available at www.ams.usda.gov/rules-regulations/hemp a supplemental document addressing Sample Guidelines
as a reference resource to industry. This resource document indicates
that hemp samples are comprised of cuttings from just underneath a
flower material located at the top one-third of the plant. Following
review of public comment from various stakeholders, AMS determined this
final rule will allow for additional sampling methodologies for
determining the sample size from the lot as described previously under
the ``Sample Size'' discussion. However, since THC is concentrated in
the flower material of the plant, the flower material is more
appropriate to test than the entire plant. The final rule specified
pre-harvest samples shall be approximately five to eight inches from
the ``main stem'' (that includes the leaves and flowers), ``terminal
bud'' (that occurs at the end of a stem), or ``central cola'' (cut stem
that could develop into a bud) of the flowering top of the plant. This
aligns provisions of this final rule with the common practices of
several States that significantly participated in the 2014 Farm Bill
hemp pilot programs. This decision further balances the need to collect
a sufficiently large portion of the plant's flower, where THC and other
cannabinoids are at their most concentrated, and the need to avoid
cutting a portion of the hemp plant that
[[Page 5633]]
poses logistical challenges to shipment, drying and preparing for
laboratory tests. AMS believes this provision will help standardize
sampling across the nation.
AMS considered the differences of pre-harvest vs. post-harvest
sampling and determined the most practicable way to identify THC
concentrations of the plant is through pre-harvest sampling since the
floral material is still intact. Floral material must be intact to
assure the material submitted for testing is in fact the flower part of
a hemp plant and it has not been compromised or mixed with other plant
parts. AMS also considered the many commenters who endorsed ``whole
plant'' sampling. AMS concluded that measuring THC concentration
through floral material testing is more appropriate and practicable
than testing the entire plant because testing the entire plant will
dilute the THC concentration in the sample, except as allowable under
remediation, as discussed elsewhere in this final rule. Further, the
study cited by a commenter that shows THC concentrations throughout
hemp plants are not consistent between varieties does not support the
use of whole plant sampling because it compares different plant
varieties, not the THC level on different parts of the same plant
variety where the sample is taken. Accordingly, sampling the top part
of the plant will provide the most accurate results.
Since THC is concentrated in the flower material of the plant, the
flower material is more appropriate to test than the entire plant. AMS
will modify the sampling requirement to state that the sample shall be
approximately five to eight inches from the ``main stem'' that includes
the leaves and flowers, ``terminal bud'' that occurs at the end of a
stem, ''or ``central cola'' (cut stem that could develop into a bud) of
the flowering top of the plant. AMS believes this consistency will help
establish a level playing field for all U.S. hemp producers. The
Sampling Guidelines issued concurrently with this rule includes
additional details.
AMS also includes additional flexibilities for disposal and
remediation of ``hot'' hemp that would reduce the costs to producers.
These are discussed later in this final rule and in separate guidelines
published concurrently.
Measurement of Uncertainty (MU)--Field Sampling
The IFR did not address the subject of uncertainty when conducting
field samples and only speaks to the measurement of uncertainty in
performing laboratory tests for regulatory compliance.
Comments: Several comments noted that not accounting for MU in
sampling is a potential oversight that should be addressed in the final
rule. Several comments note that field sampling is the largest source
of variability in any testing process, due to the choices individual
sampling agents make and field condition variability. Comments argued
that there is a wide degree of variability among individual plants in a
hemp crop and that this contributes to further uncertainty in field
sampling. Due to this uncertainty in the field during sample
collection, commenters suggested that an MU for field sampling be
included in the final rule.
Several State agriculture departments argued that the MU value
should account for variability in the steps that occur before a sample
reaches the laboratory. Comments noted the various steps in the field
sampling process, such as cutting, bagging, sealing, transporting, and
handling, and explained that each increases uncertainty in the THC
testing results before the sample even arrives at the laboratory for
compliance testing. Commenters asserted that uncertainty related to
each step in the field sampling collection process should be accounted
for in the MU.
Several comments argued that, without a standardized MU for field
sampling, some hemp crops with specific end-uses would be
disproportionately impacted. According to comments, hemp crops grown
for cannabinoids show the most phenotypic variability and lack of
uniformity in the field. Comments said this variability should be
accounted for before the sample reaches the laboratory.
One comment suggested following the ISO 15189 standards that take
into account uncertainty sources during the analytical phase where the
measurement actually occurs. Several comments requested that USDA
establish a standardized method of calculating uncertainty resulting
from sample collection procedures and for uncertainty in laboratory
testing methods. One comment noted that USDA's Sampling Guidelines do
not require the USDA-approved sampling agent to communicate to the
laboratory anything related to crop variations or the agent's sampling
methodologies that may contribute to uncertainty in testing the hemp
crop for compliance.
A comment suggested a method for calculating MU that would include
pre- and post-laboratory activities: MU would be calculated as the
square root of the sum of squared values for pre- and post-laboratory
activities, or, (a) squared plus (b) squared = (c) squared, where (a)
is field sampling activities and (b) is laboratory MU. The comment
offered this example: If the in-laboratory measurement of uncertainty
(b) is calculated as 0.0300 percent, and the field sampling measurement
of uncertainty (a) is estimated to be 0.0400 percent, then the total
measurement of uncertainty (c) would be 0.0500 percent.
An institute that commented discussed research which found that
sampling from the whole plant more accurately reflected what was
observed in a field. The comment explained how the current USDA method,
which analyzes only the top \1/3\ of the plant, generates data that is
error-prone and results that likely do not represent the actual THC
levels that are present in the hemp plants in the field as a whole. It
said, for example, in one research field, THC levels ranged from 0.06
percent to 2.46 percent in the top \1/3\ plant samples when individual
plants were evaluated separately.
The research also found significant variation in THC concentration
across plants, which the commenter attributed to the lack of ability of
the sampling procedure to generate a consistent, reproducible sample
from any given hemp field. The research found if the field contains
plants that are not completely uniform in their THC levels relative to
each other, it is possible that this small subsample in any given
analysis could over-represent plants that have higher levels of THC,
thereby leading to failure of the field. On the other hand, equally
possible, that analysis could over-represent plants that have lower
levels of THC, leading to passing the field. The research stated that
the most likely result of a sampling test is an inaccurate assessment
of the total THC levels based on the method used to sample the plants
in the field and then prepare them for extraction.
A comment from a private laboratory noted that when field sampling
and pre-analysis handling and processing is done properly and
uniformly, the pre-analysis measurement uncertainty can be reduced to
5-10 percent. The comment suggested that test results might be more
consistent and uniform when collecting samples in a ``W'' pattern with
a minimum of 10-15 individual cuttings taken from the top and middle
third of the plant.
Some comments recommended USDA conduct or fund a study to determine
appropriate requirements for calculating sampling uncertainty.
AMS response: AMS appreciates the different suggestions submitted
by commenters on ways to handle potential
[[Page 5634]]
variability and uncertainty associated with sampling. AMS recognizes
that a variability in sampling may contribute to the overall
uncertainty of the final result. For reasons explained below, AMS in
unable to adopt a national standard for calculating the MU for
sampling. However, States and Indian Tribes, may include one in their
State or Tribal plan as part of their performance-based alternative
method for sampling under Sec. 990.3(a)(2)(iii).
In order to develop a standardized approach to sampling MU, a
sampling plan must first be well-established, standardized, and studied
to accurately account for uncertainty differences in sampling
methodologies. To measure uncertainty of the complete process, from
primary sampling through analytical determination, all steps in the
process must be included. There are many intermediary steps that must
be measured, such as sampling conditions, sample preparation, sample
preservation, and transportation, all of which are not always present
and/or completed the same each time sampling occurs. States producing
hemp under the 2014 Farm Bill have developed sampling plans that vary
widely; sampling MU is not something that can be easily studied,
calculated, or broadly standardized. Due to the variability in sampling
across producers, States, and Indian Tribes, and the lack of available
data, USDA is unable to establish or standardize a specific MU value or
boundaries (upper or lower) for general use.
In the future, standards organizations, such as ASTM International
through their Committee (D37) on Cannabis, will be establishing
sampling standards that States, Indian Tribes, and producers could use
to improve or help control sampling uncertainty. USDA also recognizes
that States and Indian Tribes may have or will conduct their own study
of the sampling uncertainty within their States or territories taking
into account the conditions that may affect sampling. Those States and
Indian Tribes may be able to calculate or standardize the MU for
sampling within their States and territories. For those reasons, States
and Indian Tribes may incorporate a sampling MU as part of an
alternative method for sampling under Sec. 990.3(a)(2)(iii).
Post-Sample Harvest Window
The IFR required testing for total delta-9 tetrahydrocannabinol
concentration levels and sampling for such testing was required to
occur within 15 days prior to the anticipated harvest of cannabis
plants. The IFR required sampling to be conducted by a Federal, State,
local, or Tribal law enforcement agency or their designee.
Comments: Numerous comments expressed opposition to the 15-day
post-sample harvest window. Comments argued that a 15-day window is too
short and urged AMS to make it longer, providing several examples of
anticipated difficulties with the 15-day window.
According to comments, the 15-day sampling window in the IFR did
not allow enough flexibility to reckon with adverse weather conditions
that could delay or preempt field sampling and harvest activities.
Comments said that isolated producers and others with limited access to
harvest machinery might not be able to complete harvests within 15 days
of sampling if weather prevents them from getting into the fields.
Comments also noted that in some hemp production areas, climate changes
are trending toward wetter harvest seasons, with frequent and
catastrophic flooding in recent years. Other comments provided examples
of climate variations across the U.S. and explained that the 15-day
window is not uniformly suitable for all regions, some of which may be
more prone to early freezes and other conditions that could forestall a
timely harvest or force producers to harvest before receiving test
results in order to save their crops.
Comments also pointed out that a 15-day window does not adequately
accommodate a commonly employed two-phase harvest technique, wherein
farmers first harvest the seeds and flowers and then the plant's
stalks.
Comments additionally stated logistical challenges related to
sampling on larger hemp farms or farms with several varietals. They
asserted that the number of required samples greatly increased under
the IFR from what was required under most State administered pilot
programs, and that collecting, drying, and submitting samples for those
additional lots will be very difficult within the 15-day window. A
commenter stated that, in 2019, Colorado sampled only 23 percent of all
registered hemp lots within a 30-day sampling window under the pilot
program, while under the IFR requirements, they would need to collect
more than four times as many samples in half the time.
Many commenters--from producers, state departments of agriculture,
and Tribal governments--anticipated bottlenecking delays at laboratory
testing facilities due to the limited number of DEA-registered
laboratories available to provide testing. Comments from laboratories
agreed that the increased demand for hemp testing would strain existing
resources and make it difficult to return results to farmers in time to
complete harvesting within the 15-day window. One commenter from a
private laboratory also noted the strain on human resources this would
create to oversight activities because laboratory employees are
required to accompany sampling agents through the sampling process
within the window. Other comments noted a possible shortage of
available farm workers during a tight harvest window.
Comments from Indian Tribes stated that the requirement to test
within 15 days prior to harvest by DEA registered laboratories is not
practical for Indian Tribes, explaining that many Indian Tribes were
moved to desolate lands where growing crops is hampered by location,
quality of the land, available water and infrastructure, and access to
ready transportation. Further, Indian Tribes said growers are hampered
by the economies of size. Comments suggested that in much of the Indian
Tribe territories, Tribes will not be able to develop large farms that
reduce risk.
Many comments recommended increasing the sampling window to 30
days. Some suggested that producers be allowed to harvest before the
return of laboratory results, but not be allowed to release product
until test results are obtained. One comment added that allowing post-
harvest testing would incentivize farmers to monitor their crops prior
to harvest in order to minimize the need to destroy crops. Another
comment recommended that all hemp testing labs be required to return
results to growers within 15 days of receiving samples. Other comments
proposed revising the regulations to require only that harvest
commence, rather than be completed, within the specified period
following sampling.
Data on compliance testing from North Carolina \20\ cited a recent
study showed an average of 12.65 days taken to receive test results,
with a range of between 2 days and 41 days. It estimates that 50
percent of growers would begin to harvest before receiving the results
of their THC compliance test and 22.5 percent would complete their
harvest without receiving their results.
---------------------------------------------------------------------------
\20\ https://beta.regulations.gov/comment/AMS-SC-19-0042-5294.
---------------------------------------------------------------------------
Another State department of agriculture said it has been operating
their pilot program utilizing a 25-day harvest window but noted that 25
days has proved an insufficient amount of time in their experience
managing their pilot program. They recommend the
[[Page 5635]]
final rule utilize, at minimum, a 30-day sampling window.
A State extension service cited data from the Midwestern Hemp
Database and reports from Rock River Laboratory which shows that 68
percent of the requests for THC compliance testing were submitted
during the period of September 8th-October 1st and note this will
create a tight peak window during which samples will be submitted. Due
to this peak timeframe of compliance testing needs, several State
departments of agriculture note that during these peak times there will
be staffing shortages, delays in sampling, delays in analyzing
material, delays in the reporting of results and delays due to
unsuitable harvest conditions.
Another State department of agriculture recommends that certified
seed varieties should be sampled and tested from a random selection of
hemp grain and fiber fields 30 days prior to harvest. For uncertified
varieties, it recommends requiring a post-harvest test, as well as a
pre-harvest test of a random selection of fields within 30 days of
harvest.
One commenter discussed data showing that different cultivars
accumulate cannabinoids at different rates and at different times.
Given the rapid changes in cannabinoid levels, the comment said its
data highlights the challenges of scheduling pre[hyphen]harvest
regulatory samples and harvest dates.
Finally, a few comments asked for clarification about the 15-day
window. Some said it was unclear whether harvest must commence or be
completed within the window. Others asked whether a producer is
prohibited from harvesting before testing is completed. One comment
stated that the 2018 Farm Bill does not contain a timing requirement.
One comment reported that their current sample-to-harvest window is
25 days, and that it does not appear to be long enough to sample all
the State's outdoor hemp crops maturing concurrently.
One comment reported that the IFR's 15-day harvest window is not
feasible to implement and puts incredible stress on the developing
State's hemp industry. According to the comment, the State applied a
30-day sample-to-harvest window during the four years it participated
under the 2014 pilot program. During the 2020 growing season, the State
reported it has struggled to sample and test the 5,809 acres and 1.46
million indoor square feet that comprise the fields and facilities of
the State's 700 licensed growers within 20 days. The comment claims
that the State does not have the financial capability or staff
resources to ensure sampling can be achieved at every field within the
optimal and correct time.
Data analysis provided by North Carolina State University \21\
evaluated the 2018-2020 turnaround times for labs reporting THC test
results to growers on 3,317 lots. The analysis found that in 22.5
percent of cases, growers would have had to commence harvest with no
knowledge of their test results to meet the 15-day harvest window
requirement in the IFR. The comment asserted that in reality, growers
would need lab results in 10 days or less in order to make informed
harvest decisions, in which case they assumed approximately 50 percent
of the state growers would have had to start harvesting without knowing
their test results. The comment referenced NCSU farm cost studies that
showed farmers with some equipment at their disposal will spend
approximately $14,000 per acre on hemp cultivation. Noting that of
those costs, seed/plant acquisition and labor are the greatest
expenses, the comment asserted that harvest is the most labor-intensive
activity, and that requiring farmers to harvest without knowing whether
their hemp crop is compliant or marketable puts them at great financial
risk. The comment recommended extending the post sampling harvest
window to 30 days to reduce financial risk for farmers.
---------------------------------------------------------------------------
\21\ Ibid.
---------------------------------------------------------------------------
A comment from another state noted that given the State's size and
geography, distances between hemp production sites could be greater
than 2000 miles, making the 15-day sample-to-harvest window impractical
for them. The comment recommended allowing States and Tribes, who are
better aware of their geographies and resources, to determine their own
windows, up to 30 days.
One comment reported the State has three inspectors geographically
dispersed throughout the State, servicing approximately 200 farms
harvesting within the same 8-week time period. The comment advocated
extending the harvest window to 30 days to cope with unforeseen weather
events, extended travel, lab turnaround, resampling and testing, and
other delays.
One comment contained preliminary findings from an ongoing 2020
study \22\ conducted by a state and a state university that showed
different cultivars of hemp accumulate cannabinoids at different rates
and at different times in plant maturity. Study data showed that some
cultivars can rapidly accumulate THC and CBD, with weekly changes of as
much as 0.1 percent THC and 1.5 percent CBD in some cases. The study
found that the rates of THC and CBD accumulation were parallel in the
four cultivars studied, with the CBD:THC ratio staying consistent
around 24:1. The study concluded that given the rapid rate of change in
cannabinoid levels, samples taken 2, 3, or 4 weeks prior to harvest may
not accurately reflect the cannabinoid profile of the harvested
material. The study further concluded that a larger harvest window
increases the likelihood that non-compliant plant material will be
harvested and potentially rejected at market, costing the grower the
additional expense of harvesting.
---------------------------------------------------------------------------
\22\ Pearce, Bob et al. Sequential Sampling of Four Hemp
Cultivars for Cannabinoids--2020; University of Kentucky, College of
Agriculture, Food, and Environment and Kentucky Department of
Agriculture. https://beta.regulations.gov/comment/AMS-SC-19-0042-5762.
---------------------------------------------------------------------------
AMS response: AMS recognizes weather and climate-related factors
affect all cycles of agricultural production including pre-planting,
planting, management, and harvest. AMS also understands these factors
may vary by region from year to year, and that certain conditions might
cause some farmers to alter their normal harvest timeframe as a result
of factors beyond their control as mentioned in several comments. It is
common agricultural practice to harvest crops taking into consideration
weather patterns such as rain, wind or freezes. Producers also harvest
crops based on the availability of labor and transportation, crop
rotation and market demand among many factors. A 15-day harvest window
may not allow producers the flexibility needed to take all these
factors into consideration.
AMS considered the impact of the 15-day window on resources needed
for sampling and testing activities. We acknowledge that sample
collection may require an authorized sampling agent to visit multiple
farms of varying sizes over a very short period of time. AMS further
understands that in some places, the sampling agent may visit a farm on
multiple occasions due to the size and harvest cycle of the farm. AMS
also considered the turnround time for producers to receive results
from laboratory testing.
This final rule allows farmers to commence harvests before
receiving test results, as did the IFR. However, crops may not be
released in commerce or further processed until tests confirm that the
lots in question are compliant with the regulations. Harvests must be
completed within the 30-day timeframe
[[Page 5636]]
provided by the final rule. AMS does not believe harvests should occur
after that time because, generally, total THC levels continue to
increase with time and there is too great a risk that the levels would
increase after 30 days and thus the sample that was tested would not be
an accurate reflection of the total THC of the harvested crop.
Regarding comments on laboratory resources, AMS considered input
from our Science and Technology Program, which conducts laboratory
testing for numerous agricultural commodities and oversees our third-
party laboratory approval program. AMS assessed testing activities,
which include the receiving, selection, drying, processing (through
liquid or gas chromatography), analysis, storage, and reporting of hemp
test results. AMS considered the time necessary to ship samples to the
laboratory and to issue test results back to the grower, recognizing
that not all farms have readily available internet to expedite receipt
of electronic laboratory notifications. Standard mail may be the
primary means of communication for rural populations in certain regions
and Tribal lands. AMS also considered the level of routine work at
testing facilities across the nation and their capacity to efficiently
process hemp samples while continuing unrelated, non-hemp laboratory
activities. AMS agrees that it may be difficult at the peak of the
season for high-volume laboratories to consistently issue timely
results to growers, as producers experienced and DEA acknowledged,
impacting growers' ability to make harvest decisions.
Based on comments received and knowledge of agricultural practices,
AMS determined that the post-sampling harvest window should be extended
to allow hemp harvests to be completed within 30 days after sampling.
AMS believes allowing the additional time will provide flexibility for
dealing with unforeseen weather events and other agricultural factors,
and better accommodate complicated harvest processes. AMS also believes
this will reduce strain on testing resources and ensure test results
can be returned to growers on a timely basis.
Laboratory Accreditation--Laboratory Approval Program (LAP) and
International Standards Organization (ISO)
The IFR required hemp growers to obtain testing from DEA-registered
laboratories to ensure proper handling, disposal, and reporting of
samples that exceed allowable THC limits for hemp and may therefore be
controlled substances. As part of the IFR, AMS asked stakeholders
whether laboratory accreditation should also be required for hemp
testing labs. Specifically, AMS asked about accreditation through AMS's
LAP, through the ISO standards (ISO 17025), or through both, and if so,
which would be preferable.
Comment: Comments reflected a range of views across the industry,
both in support of and opposition to additional laboratory
certification requirements. In general, commenters preferred more
regulatory flexibility to address the widespread concern of
insufficient laboratory capacity as a result of laboratory
certification/registration/accreditation requirements imposed by USDA
regulation.
Supportive of LAP and ISO: Some comments supported requiring
additional accreditation through both LAP and ISO. Comments explained
that LAP accreditation imposes analytical standards and limits that
ensure reliable and consistent results across hemp labs, while ISO
17025 accreditation ensures that labs adhere to their own established
protocols. Comments asserted that additional accreditation is essential
to ensure that laboratories, government entities, and farmers comply
with regulations. One comment that supported requiring both
accreditations said the scope of the ISO 17025 standards should include
hemp testing methods.
One comment said requiring LAP and/or ISO accreditation in
conjunction with DEA registration is a step in the right direction
because current standards are subpar and do the industry a disservice,
while adding LAP and/or ISO accreditation would provide a baseline
standard that benefits all stakeholders, including consumers.
Either LAP or ISO: Other comments advocated requiring additional
accreditation through either LAP or ISO, but not both. Comments said
that requiring one or the other would be adequate to provide testing
integrity, but that requiring both would unnecessarily overburden labs
and create a testing bottleneck as labs worked toward accreditation.
One comment said that since hemp products are consumable, public health
and safety should be of paramount concern when choosing a lab
accreditation program.
Comments supporting LAP accreditation specifically said such
accreditation would improve grower access to qualified labs and would
improve the efficiencies and protect the competitive interests of non-
DEA labs. Comments favoring LAP accreditation pointed out that LAP
already incorporates ISO 17025 standards and includes regular audits
and records management requirements. Comments added that incorporating
ISO standards into LAP accreditation lends confidence in testing
procedures and results, which in turn creates a fair marketplace for
hemp. They asserted that the benefits of LAP accreditation outweigh the
costs because they emphasize quality controls and accurate analytical
performance by knowledgeable and trained staff. One comment suggested
that using LAP-approved labs would facilitate USDA's hemp program
oversight and the development of an evidence-based data tracking
system. Another comment pointed out that LAP offers growers a complete
online listing of qualified labs from which to choose.
Some comments argued against adopting LAP accreditation, saying the
accreditation process is expensive and burdensome for laboratories, and
that the user-fee program benefits only USDA. One comment said that it
is unclear from the IFR how LAP differs from ISO and whether LAP
accreditation offers more confidence in test results than ISO
accreditation. Another comment said that LAP accreditation would be
redundant to ISO accreditation and is not necessary.
Some comments favored the use of laboratories with ISO 17025
accreditation in addition to or instead of DEA-registration. Comments
noted that hemp laboratories in many States already have ISO
accreditation, although some are not DEA-registered. They suggested use
of those labs should be grandfathered into approved hemp production
plans. Some comments asserted that between LAP- and ISO-accreditation,
ISO is the best alternative for the hemp industry because it meets the
needs of the hemp industry, and at a reported cost of $25,000, it
reduces unnecessary expense and regulatory burden for labs and growers.
One comment recommended that USDA specify that the most current ISO
17025 standard be required for accreditation--the 2017 version.
Neither LAP nor ISO: Several comments opposed requiring additional
laboratory accreditation on top of DEA-registration. Some comments
called it ``overkill,'' and said requiring additional accreditation
would put an undue strain on laboratories and delay testing and
reporting results for growers.
None of the Above: Several comments opposed specifying any
particular laboratory registration or accreditation and recommended
instead that States and Indian Tribes be authorized to determine
appropriate standards for hemp testing laboratories under their
respective production plans. Comments said that allowing States and
Indian Tribes to determine their own lab
[[Page 5637]]
certification schemes would allow them to maintain appropriate testing
capability while finding the best fit for the economic profile of their
regulated jurisdictions. One comment suggested USDA encourage
laboratories to participate in the Hemp Proficiency Testing Program
established by the University of Kentucky, rather than building an
accreditation program from scratch through LAP.
Other Alternatives: One comment asked USDA to clarify why any
additional accreditation should be required. Another comment suggested
that if laboratory accreditation is necessary, AMS should explore the
most cost-effective choice from among LAP, ISO, or other commercial
accreditations to minimize costs for growers. A comment suggested that
DEA-registered labs not be required by the rule but be allowed as
backups for labs with other accreditations. Another comment speculated
that if only LAP or ISO accreditation were required, and DEA
registration was not, growers would test their crops more frequently.
Some comments recommended that no specific accreditation be required
because the process is too costly and time consuming and would
discourage labs from participating in the program. One comment
suggested that USDA encourage labs to adhere to ISO 17025 standards,
but not require accreditation.
Some comments suggested that LAP accreditation would be beneficial
to the industry, but that such a program should be developed
incorporating the expertise of former DEA or other chemists with
experience testing cannabis. Other comments supported using ISO-
accredited labs until LAP accreditation can be fully developed and used
on a trial basis to gather adequate experience and data. One comment
suggested allowing States, Tribes, and USDA to contract with commercial
labs or use private labs that adhere to ISO standards.
AMS response: AMS noted that commenters generally preferred more
regulatory flexibility to address the widespread concern of
insufficient laboratory capacity as a result of laboratory registration
requirements outlined in DEA regulations. Adding ISO 17025 or other
accreditation requirement to laboratories would decrease the number of
laboratories available to perform hemp tests. AMS also noted some
commenters opposed accreditation requirements due to cost implications
and additional burden. While we strongly encourage laboratories to be
accredited to ISO/IEC 17025 (by an International Laboratory
Accreditation Cooperation Mutual Recognition Agreement (ILAC MRA)
signatory accreditation body), because it will help ensure lab results
are more accurate, ISO 17025 accreditation requires significant time
and financial commitment to pursue and maintain. This it is most
challenging for smaller and start-up labs. The initial accreditation
can cost $5,000-$10,000 (and in some case more) and yearly ongoing
costs are $3,000-$8,000. Smaller labs may not have the resources to
pursue accreditation in a timely manner or they may have to spend more
time and money for consultants to assist them in setting up a quality
management system and to navigate the application and audit processes.
Based on this input, AMS will not require USDA administered lab
approval program or require ISO 17025 accreditation because doing so
would increase the financial burden on producers and reduce the
availability of laboratories that can test for THC level in hemp. AMS
is committed to continue looking into this option.
DEA Laboratory Registration Requirement
The IFR required that laboratory testing of hemp for the purpose of
determining compliance under the program be conducted by laboratories
appropriately registered with DEA. However, on February 27, 2020, USDA
announced guidance delaying the requirement to use laboratories
registered with DEA for testing. 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 deadline
was later extended to December 31, 2022. This change was intended to
allow additional time to increase DEA-registered analytical lab
capacity.
Comments: A few comments supported the DEA-registration
requirement. Some comments favored dual laboratory accreditation (e.g.,
DEA and ISO 17025 accreditation or DEA and AMS LAP accreditation)
saying that such combinations would assure technically competent,
unbiased testing and results reporting. One comment agreed with DEA lab
registration but said that labs that have applied for DEA registration
by Nov 1, 2020, should be allowed to continue testing (as under pilot
programs) as the certification process takes so long. It further
observed that while the IFR seemed settled on HPCL as the testing
method, the rule does not specify the detection method as it should.
The comment recommended mass spectrometry as the most accurate.
Another comment agreed with DEA lab registration, saying that
otherwise, any lab could be handling controlled substances without
observing stringent DEA requirements. The comment argued that allowing
any lab to test hemp creates an unfair business advantage for non-DEA
labs that do not have to pay high costs of maintaining DEA
registrations. Further, those non-DEA labs would be handling controlled
substances inconsistent with Federal law.
More commonly, comments opposed the DEA-registration requirement
for hemp testing laboratories. Commenter concerns were as follows:
Logistics: Numerous comments stated there are not enough DEA-
registered labs to handle the volume of samples required under the
IFR's sampling and testing regulations. Comments predicted that such
limited capacity would exacerbate existing bottlenecks, greatly
increasing the likelihood that THC levels in sampled crops would
continue to rise while farmers wait for test results. Several comments
noted that the IFR allowed farmers to harvest sampled crops before
receiving test results, however many prefer not to expend time and
money harvesting a crop that might not be marketable. Comments also
anticipated growers' testing fees would increase to cover the addition
of testing resources at existing DEA-registered labs.
Some comments noted that not all States or Tribal lands have DEA-
registered labs within or near their boundaries. According to comments,
where DEA labs do exist, they are generally located in urban areas at
some distance from rural farms. They explained that the scarcity of
DEA-registered labs in reasonable proximity to farms will increase
costs for transporting samples and increase the turnaround time for
obtaining test results. Some comments submitted by Indian Tribes also
asserted that the DEA had failed to consult with Tribes about its
accreditation process and that it failed to timely respond to Tribes'
requests for lab results.
Accreditation: Comments said that DEA-registration is costly and
time consuming for laboratories and that such expenses would discourage
existing labs from seeking DEA registration. One comment said that DEA
accreditation is too expensive to be required for ``low-level THC
testing.'' Comments suggested alternatives, including:
Allow testing by labs accredited under ISO 17025
Allow testing by labs approved under AMS's LAP
[[Page 5638]]
Allow testing by labs accredited by States or Tribes
Allow testing by labs accredited under other accreditation
programs
Allow testing by labs with dual accreditation (e.g. DEA and
ISO, or DEA and LAP)
Allow continued testing by labs approved to do so under the
2014 Farm Bill
Allow for a transition period to allow labs time to work
toward registration
One comment suggested that allowing for alternative laboratory
accreditation would increase competition between labs, reduce costs for
growers, and reduce the potential bottleneck created by allowing for
only DEA-registered lab testing.
Another comment argued that although accreditation is costly,
relying on it could help enforce strict standards and ensure less
variability between testing labs. Some comments suggested USDA fund
accreditation of private labs to help offset the cost of expensive
accreditations and encourage more labs to seek necessary accreditation.
Other comments suggested DEA expedite its lab approval process and
make it easier for existing labs to obtain DEA registration.
Other commenters stated that the DEA lab accreditation process
requires State approval and not Tribe approval and that this is
unworkable because of occasionally difficult relationships between some
Tribes and States and because hemp is prohibited in a couple of States.
Finally, several comments recommended AMS provide a phase-in period
of as much as two years to allow existing labs to continue hemp testing
while they work toward DEA registration so the industry will have
access to adequate testing options during its development.
DEA and Controlled Substances: Comments expressed concern about
many aspects of DEA's involvement with the hemp program. Comments
argued that hemp is a legal agricultural commodity under the 2018 Farm
Bill and requiring testing by DEA labs insinuates hemp is a controlled
substance regulated under the Controlled Substance Act. Commenters
asserted that treating hemp as a controlled substance exceeds the
intent of the 2018 Farm Bill. Comments also suggested USDA's IFR
impeded Congressional intent to foster the development of a new
agricultural sector.
One commenter representing a processor of hemp, specifically for
CBD products, said they were concerned about an IFR published by DEA
and that the rule by DEA could inadvertently criminalize hemp at
various stages of its production process. They encouraged USDA to
eliminate DEA's involvement.
Comments also said DEA involvement in USDA's program discourages
participation by laboratories and by growers, neither of whom may care
to risk prosecution for inadvertent criminal acts if a test result
indicates they raised or possess a controlled substance. Some comments
said private labs with ISO or other accreditation don't want to obtain
DEA accreditation, fearing the tension it will cause between themselves
and their grower customers because of the requirement to report
potential criminal activity. Other comments said growers fear
repercussions related to possible felony prosecution for growing crops
considered illegal, including loss of chemical application permits that
allow them to manage other crops. One comment argued that it isn't
necessary to involve DEA in hemp testing, that it distracts that agency
from other vital Federal work.
According to some comments, most DEA-registered laboratories are
crime labs that do not offer commercial testing services. As reported
by a State, the DEA may be reluctant to even visit--let alone approve--
certain laboratories because of the handling and testing of marijuana,
although considered legal by the State. Other States with legal medical
and/or recreational marijuana provisions commented that their labs may
not want to seek DEA registration because they choose to focus on
marijuana testing. Some comments said labs that handle marijuana may
not in fact obtain DEA registration, thus laboratory capacity to
process hemp samples at the volume and speed required by the IFR may
not materialize.
One comment assumed DEA-registered labs might test only for
cannabinoids, while other commercial labs would be able to perform
additional testing, for instance for microbes, heavy metals, and
pesticide residues, saving growers the additional expense of multiple
tests.
Some comments recommended USDA waive the requirement to use DEA-
registered labs in States where recreational marijuana is legal, thus
increasing the number of labs available for hemp testing. Other
comments recommended DEA change its standards to allow labs that handle
legal marijuana to also handle hemp.
Cost Management: A few comments suggested that restricting hemp
testing to DEA-registered labs creates a monopoly among labs that
already have such accreditation or have the financial backing of large,
vertically integrated companies to enable them to do so. Comments
recommended that existing State, Indian Tribe, university, or other
Federal labs with demonstrated ability to perform testing according to
USDA standards be allowed to do so, thus providing opportunities for
more interested participants and keeping testing costs down for
growers. Some comments suggested USDA contract with State, Tribe, or
Federal labs to provide required testing. Other comments recommended
capping costs for DEA-registered lab testing at $25-$50 per test.
Alternatives: One comment asked USDA to clarify whether all
independent labs must be DEA-registered to test hemp or whether only
State labs needed to obtain that accreditation.
AMS response: In consultation with the Department of Justice, AMS
determined it must retain the provisional requirement that laboratories
testing hemp for the purposes of regulatory compliance be registered
with DEA. This requirement further extends to any laboratory testing
hemp throughout the growing season to informally monitor THC
concentration. The basis for this determination is rooted to the
statutory requirements of the Controlled Substances Act (CSA), which
requires any laboratory that might potentially handle a controlled
substance to undergo the DEA registration process. The CSA states that
it is unlawful to possess a controlled substance (21 U.S.C 844) and
requires any laboratory that might potentially handle a controlled
substance to undergo the DEA registration process (21 U.S.C. 822) with
a few specific exemptions. Further, 21 CFR 1301.13 includes categories
that require registration with DEA, including chemical analysis where
laboratories fall.
AMS is aware through stakeholder comment that many stakeholders
oppose the DEA registration requirement. AMS is also aware of widely
held concern among stakeholders, especially Indian Tribes, that an
insufficient number of DEA-registered laboratories exist and have
limited accessibility to those in rural or regional locations away from
metropolitan areas. AMS understands how this combination of variables
leads to delays in sample processing by DEA-registered laboratories and
how this affects producers' harvest timetables. AMS also knows that
since the IFR was published, numerous laboratories have applied for
registration and DEA is
[[Page 5639]]
working diligently to process these requests. For this reason, DEA is
delaying enforcement of this requirement until December 31, 2022. AMS
anticipates this delay will provide adequate time for testing
facilities to obtain DEA registration.
While we understand the commenters' concern about DEA involvement,
the 2018 Farm Bill distinguishes hemp from marijuana, a controlled
substance under DEA's regulatory authority, based on the THC
concentration level in the cannabis plant. Although a producer may have
intended to cultivate hemp, it is possible that the plant is marijuana
because of the THC concentration level. If that is the case, the
producer would then be subject to DEA regulations and jurisdiction.
USDA coordinated with DEA so that producers that inadvertently produce
marijuana may be able to take remediation steps consistent with DEA's
regulations to avoid potential criminal liability. Additionally, the
2018 Farm Bill makes clear that negligent production of hemp will not
subject the producer to criminal enforcement activity. See 7 U.S.C.
1639p(e)(2)(C).
AMS also acknowledges that some laboratories believe the DEA-
registered laboratories are crime labs that do not offer commercial
testing services and DEA may be reluctant to approve laboratories
because of the handling and testing of marijuana, although considered
legal by the State. However, AMS does not have any information that
would support this belief. AMS is aware that DEA continues to add
laboratories to their approved list.
Accordingly, any laboratory testing hemp for purposes of regulatory
compliance must be registered by DEA to conduct chemical analysis of
controlled substances (in accordance with 21 CFR 1301.13). Registration
is necessary because laboratories could potentially handle cannabis
that tests above the 0.3 percent concentration of THC on a dry weight
basis, which is, by definition, marijuana and a Schedule 1 controlled
substance. Instructions for laboratories to obtain DEA registration,
along with a list of approved laboratories, are available on the USDA
Domestic Hemp Production Program website.
Laboratory accreditation options are discussed earlier in this
rule. USDA does not have any authority over the DEA's laboratory
accreditation process.
DEA's IFR published August 21, 2020, (85 FR 51639) is out of the
scope of this final rule.
Measurement of Uncertainty (MU)--Laboratory Testing
The IFR required that laboratories calculate and include the
measurement of uncertainty (MU) when they report THC test results.
Comments: Several comments expressed support for requiring that the
MU be accounted for when testing the THC concentration of hemp due to
the variability in laboratory testing equipment and complex
mathematical principles involved. Comments generally emphasized that
the inclusion of a standardized MU was needed for the industry to
develop, as hemp farmers should not be exposed to risks of economic
loss that are created by mathematical inconsistencies within an
individual laboratory's computations. Several comments emphasized the
importance of USDA clarifying the method for MU calculation in the rule
because it is part of what determines whether hemp must be disposed.
One commenter cited a study \23\ that found that test results on
samples from each field sent to five different labs deviated
significantly, ranging from a low of 22 percent deviation to a high of
41 percent depending on the field.
---------------------------------------------------------------------------
\23\ Evaluation of methods used to sample hemp for regulatory
compliance testing;'' Gang, David R. and Anna Berim; Washington
State University, Pullman, WA; 2020.
---------------------------------------------------------------------------
Some comments expressed the need for a standard, specific MU in the
final rule to prevent licensees from ``shopping around'' for
laboratories with the most lenient testing. Comments noted there is no
universally accepted way to calculate MU, so differences in MU values
used by various laboratories are just as likely to result from
differences in calculation method as they are from differences in
instrument quality or use. Several comments explained that the lack of
a standardized MU in the rule incentivizes inaccuracy by potentially
driving customers to laboratories willing to use MUs with greater
ranges.
Many comments advocated specifying an MU to create uniformity in
testing across the nation. One comment noted that variation in MU
values could be problematic for interstate commerce and result in a
hemp crop that is compliant in one state being shipped to another state
where it would be considered noncompliant. Other comments argued that
it may be too soon in the scientific process for USDA to include a
standard MU because laboratories, particularly in States that didn't
previously have cannabis programs, haven't had time to do the research
necessary to determine an appropriate MU.
Comments from States that administered pilot programs under the
2014 Farm Bill offered several suggestions on approaches to MU
calculations. A comment recommended using laboratories participating in
the University of Kentucky--Division of Regulatory Services' Hemp
Proficiency Testing Program to establish an MU through a set of
guidelines rather than in the rule. The commenter concluded that the
Hemp Proficiency Testing Program could be tasked with calculating and
announcing an MU that would be used for compliance testing purposes on
a nationwide basis. The comment added that including the MU in the
guidelines rather in the rule would allow it to be refined over time as
instrumentation and calculations develop, rather than having to modify
the hemp regulation.
Some comments advocated having multiple testing methodologies to
choose from and including requirements for calculating MU for each
method. Other comments recommended that instead of requiring a specific
MU, USDA should determine a maximum threshold for allowable MU value.
Comments argued that a maximum threshold would prevent forum shopping
by consumers looking for laboratories with the most lenient MU ranges,
but still allow laboratories to use their own calculations. One comment
recommended revising the MU provision of the IFR to include a maximum
uncertainty level that laboratories cannot exceed and suggested the
maximum uncertainty value should be one-third or less of the target
uncertainty. Another comment suggested USDA use guidelines from the
United States Pharmacopeia for determining THC concentration, which
include calculations for significant figures such as MU.
A comment asked USDA to clarify the role of significant figures in
using MU to determine total THC concentration because, they argued, in
both of the IFR's examples for determining compliance, the lower end of
the range can be written as 0.3 percent, if rounding to match
significant figures. It suggested requiring the lower value of the THC
calculation distribution range, which accounts for uncertainty, to be
less than or equal to 0.30 percent rather than 0.3 percent.
One commenter stated that for the cannabis plants exceeding the
acceptable THC levels, USDA should incorporate a MU for laboratory
deviation of .0500 percent for the many different variable ways that a
sample arriving at a laboratory could result in an inaccurate test.
This includes cutting,
[[Page 5640]]
bagging, sealings, transporting, handling, and other pre-laboratory
activities.
One comment cited guidance from the National Institute of Standards
and Technology providing that assigned uncertainty should be small
relative to the total uncertainty targeted for test samples. The
comment asserted that, as a rule of thumb, assigned uncertainties
should be about one-third or less of the target uncertainty to ensure
that uncertainty in the certified value will have negligible influence
on the results of measurements. According to the comment, laboratories
with well-developed processes will provide the most accurate and
precise results and their uncertainty will be very small. The comment
advocated that USDA provide an uncertainty range that cannot be
exceeded by participating laboratories, thereby reducing the risk that
producers will shop for laboratories with the widest uncertainty. The
comment asserted that such a provision would also improve data
comparability across the hemp industry.
AMS response: AMS appreciates the different suggestions submitted
by commenters on ways to improve the calculation of MU and also
acknowledges the variability in laboratory testing equipment that may
exist. However, based on the input received and limited data available
at the time of its review, AMS will only require that hemp testing
laboratories complete a MU calculation as part of the mathematical test
result for THC concentration. This final rule does not establish or
standardize an upper or lower boundary for general use by laboratories
to calculate a measurement of uncertainty. MU is typically not
standardized, but rather is controlled using test methods controlled by
performance standards (e.g., AOAC Standard Method Performance
Requirements 2019.003 that can be found at https://www.aoac.org/resources/smpr-2019003/).
USDA does not recommend establishing a MU upper limit (maximum)
because (1) MU is typically not standardized, but is controlled using
standard test methods, and (2) USDA does not have the data to set an
upper limit, so setting it would be arbitrary, not scientific. The hemp
and scientific industries are just beginning to discuss standard test
methods, and the final rule does not establish an explicit test method.
Setting an upper limit or maximum MU does not resolve the core issue
and would not encourage or drive labs to improve accuracy and
precision.
Setting an upper limit would in effect be setting a maximum or
absolute MU. This may encourage labs to adopt the maximum MU as their
MU, rather than drive for a smaller uncertainty. USDA may allow for
establishing limits in the future, if needed, once methods are
established and USDA has access to Proficiency Testing results and the
reported MUs.
Additionally, this rule retains the flexibility for State and
Tribal Departments of Agriculture to include specific requirements
regarding MU for laboratories conducting hemp regulatory testing under
their specific state or Tribal hemp programs if they meet the minimum
standard set in this final rule. AMS encourages State and Tribal
regulatory agencies to coordinate in developing proficiency and testing
methods, similar to the program administered by the University of
Kentucky, but participation in these types of programs is not required
by this regulation.
Disposal
The IFR stipulated that cannabis exceeding an acceptable THC level
must be disposed of in accordance with the CSA and DEA regulations
because such material constitutes marijuana, a Schedule I controlled
substance under the CSA, rather than hemp.
Destruction vs. Disposal: Several comments noted that the 2018 Farm
Bill specifies only ``disposal,'' of hemp testing above the acceptable
THC level, yet the IFR required ``destruction'' of such material.
Comments argued that the IFR's destruction requirement is an overreach.
Comments asked USDA to revise the regulations to require only disposal
of non-compliant plants or plant parts, and to provide either general
parameters or specific provisions regarding acceptable methods of
disposal. Several comments asked AMS to provide or expand the
requirements for disposal of non-compliant material.
Although a few comments supported destroying non-compliant hemp
crops, most comments that addressed the topic argued against total crop
destruction if alternative disposal methods are available and
practical. Comments explained that crop loss is financially devastating
to growers--and doubly punitive if the grower must pay to destroy the
crop--as well as a waste of valuable resources that could be repurposed
and provide at least some return to growers. Comments explained that
crop destruction can be a drain on limited official resources,
depending on the availability of law enforcement personnel and
equipment for the potential need to collect, transport, and oversee the
destruction of non-compliant plant material. Further, a comment from an
Indian Tribe noted that requiring crop destruction is culturally
offensive to indigenous people that traditionally use every part of
every animal and plant that can be utilized.
Disposal Methods: Several comments asserted that the only disposal
methods available under DEA regulations are incineration or chemical
digestion and argued that the current rules under the CSA are designed
for disposal of pharmaceuticals and chemical-based illegal drugs, not
for the disposal of agricultural crops. Comments asserted that
incineration by DEA is not efficient or environmentally sound, and in
some places may not be allowed. They noted that burning crops releases
harmful carbon dioxide and other pollutants into the air, contributes
to the risk of wildfires, and wastes valuable plant nutrients that
could be used elsewhere.
Numerous comments stated that the rule should provide alternative
methods of disposal for non-complaint hemp plants to protect growers
against total crop loss and preserve valuable resources. Several
comments recommended USDA adopt disposal rules established under their
various State and Tribal regulations. Comments suggested growers be
allowed to mulch or disc the non-compliant crop into the soil at the
farm, which would build up soil nutrients, improve soil water holding
capacity, and improve soil tilth. Other comments suggested growers
could recuperate some of their investment by marketing non-compliant
crops for other non-ingestible or non-consumable products like fiber,
building materials, biofuel, biochar, bioplastics, and animal bedding.
A few comments suggested growers should be permitted to export or ship
non-compliant hemp to countries or States that have legalized
recreational or medical marijuana. Numerous comments recommended a
surgical approach to disposing of non-compliant plants by allowing for
the removal and disposal of only the plant parts testing over the
acceptable THC level, while allowing growers to market the remaining
parts. One comment suggested the Federal Government could buy non-
compliant crops for no less than 50 percent of the market value and use
them to manufacture paper, plastics, and fuel for government and
military uses. Other comments proposed remediation as an alternative to
crop destruction; comments on remediation are discussed in another
section of this comment analysis. One comment suggested further
research be conducted to identify appropriate alternatives for crop
disposal, and one comment
[[Page 5641]]
suggested that industry stakeholders, governments, regulators, and law
enforcement officials work together to develop disposal options under
the program.
Disposal Oversight: Several comments recommended that States,
Indian Tribes, or local authorities be allowed to determine appropriate
crop disposal methods for their jurisdictions. Comments further
recommended that State, Tribal, or local regulatory officials be
authorized to oversee disposal of non-compliant hemp, as several have
done prior to the establishment of the Domestic Hemp Production
Program. One comment recommended further that hemp disposals handled by
the State should not imply criminal intent on the part of growers.
Comments said that allowing for local oversight would reduce strain on
DEA and other law enforcement resources and ensure disposals can be
handled on a timely basis. One comment from a State agriculture
department said that when law enforcement officers have been invited to
attend crop disposals in their jurisdiction, officers are typically
unavailable. Other comments argued that growers should automatically
become DEA-registered reverse distributors if their test results exceed
acceptable hemp THC levels so they can dispose of the non-compliant
crops themselves and provide acceptable evidence (e.g., photo or video)
that they have done so, or so they can do so in the presence of
regulatory officials. Some said USDA should pay for official oversight
of crop disposal or there should be no charge for that service.
Comments noted that AMS had not yet posted disposal guidelines on
its website at the time those comments were submitted, although the IFR
had committed AMS to doing so. Some comments said interested entities
were unable to complete applications for program participation because
AMS had not yet provided disposal requirements.
Several comments asserted that DEA regulations do not mandate
specific disposal methods, so long as the ``desired result'' is
achieved. Comments asked for more specifics on DEA disposal procedures,
including what disposal methods or processes were allowed under the
IFR, what the timeline is for disposal, and what results are desired.
One comment asked whether all of a grower's crops would be disposed
if one of the lots tested above the acceptable hemp THC level. Others
asked whether marketing non-compliant crops for non-ingestible and non-
consumable products would be considered a form of disposal. One comment
asked whether USDA would consider providing crop insurance for losses
due to disposal of ``hot'' crops. One comment asked whether stored hemp
product produced under previous programs that allowed for higher THC
levels would be disposed under the new program, or could be
``grandfathered'' in.
One comment contended that certain language in the IFR was
inconsistent, and as a result, the IFR could be interpreted to require
disposal of hemp that does not meet the IFR's definition of hemp,
rather than the disposal of hemp that does not meet the acceptable hemp
THC level.
AMS response: AMS received significant comments on this requirement
from State and Tribal regulatory agencies, producers, and other hemp
industry stakeholders and based on this input, AMS determined it
necessary to include specific on-farm hemp disposal activities and to
provide oversight flexibilities.
As explained in the IFR, State and Tribal plans are required to
include procedures for ensuring effective disposal of plants produced
in violation of this Part. As part of its review, AMS noted the
cultural implication of the use of the term `destruction' and
accordingly amended the regulatory provision to clarify the disposal
activities required of growers in cases when a sample tests above the
acceptable total THC level.
AMS also determined that producers benefit from greater regulatory
flexibility to control on-farm disposal activities according to
production schedules that are not dictated by the availability of
reverse distributors to physically witness disposal activity. State and
Tribal plans must still include procedures to verify disposal. This may
come in the form of in-person verification by State or Tribal
representatives, or alternative requirements the direct growers to
provide pictures, videos, or other proof that disposal occurred
successfully. State and Tribal plans must also include requirements to
submit to AMS the monthly disposal report documenting any on-farm
disposals that occurred during the prior month. Additional information
on specific disposal methods is available to producers, State, and
Tribal oversight agencies is available on the AMS website.
Disposal through the agricultural practices appearing in this final
rule reflected those allowable under the IFR, and previously published
to the AMS web page in February 2020. These included plowing under,
mulching/composting, disking, bush mower/chopper, deep burial, and
burning. These activities align with normal and routine production
actions by farmers. AMS believes specifying these activities help hemp
growers determine which activity best supports their operation to
transition non-compliant crop into a non-retrievable or non-ingestible
form. These methods also allow recycling non-compliant plant materials
back into the earth, a viewpoint AMS learned through public comment to
be especially relevant for producers practicing cultural conservation
practices. AMS recognized that controlled burning is the closest farm
practice to incineration but controlled burns may not be a viable
option for producers in some places due to wildfire risk or state
prohibition against using controlled burns.
Remediation
The IFR stipulated that cannabis exceeding the acceptable THC level
must be disposed of in accordance with the CSA and DEA regulations
because such material constitutes marijuana, a Schedule I controlled
substance under CSA, rather than hemp. In addition, the IFR stated that
noncompliant plants may not be further handled, processed, or enter the
stream of commerce, and that the licensee shall ensure the lot is
disposed. The IFR did not stipulate any provisions to allow for
remediation activities that reduce the THC concentration to levels
within the acceptable limit.
Remediation of non-compliant crops into compliant plant biomass:
Numerous comments expressed support for remediation of non-compliant
plants to help farmers mitigate against financial loss. Comments
claimed that not having remediation options would be a barrier to
industry growth because farmers would be unable to bear the financial
risk of losing crops. One commenter used 2019 production and economic
data to project that applying the IFR to 2019 statewide non-compliant
test rates (17 percent), farmgate losses due to crop destruction could
have totaled $842.6 million in Colorado.\24\ According to the comment,
adding losses related to lost processing and manufacturing due to the
same crop destruction could have brought the economic cost to
approximately $1.2 billion. It suggested that allowing for remediation
of non-compliant crops testing between 0.3 and 1.0 percent THC in the
same scenario would preserve
[[Page 5642]]
about $798 million in direct farmgate value, or $1.1 billion of total
economic value for the State.
---------------------------------------------------------------------------
\24\ Polis, Jared; Phillip J. Weiser; and Kate Greenwood: State
of Colorado Comments in Response to USDA Establishment of a Domestic
Hemp Production Program; https://beta.regulations.gov/comment/AMS-SC-19-0042-3358.
---------------------------------------------------------------------------
Numerous comments explained that non-compliant plants can be
remediated by chemical processes that either remove and destroy THC or
dilute THC concentrations, thereby transitioning the remaining material
into biomass blends which then test at or below the Federally allowable
THC threshold of 0.3 percent. Thus, according to comments, crop
remediation through one of these processes is a viable alternative to
total crop loss. Some comments suggested processors could be registered
with DEA to handle such remediation processes to ensure THC is
extracted, handled, and disposed or marketed legally. Other comments
suggested that USDA could issue processor permits to allow them to
handle hot crops to bridge the perceived legal gap between farmer and
consumer. Some comments further suggested growers could bear processing
costs then retake possession of the remaining biomass for use or sale
elsewhere. Several comments suggested growers themselves could be
allowed to merge ``hot'' lots with lots testing below allowable hemp
THC limits to create a compliant, homogenized blend.
Some comments suggested non-compliant crops could be remediated by
removing the only flowers and retaining the seeds and stalks for other
use. Other comments argued that the IFR testing provisions conflict
with CSA provisions that exempt seeds and stalks of plant material from
the definition of marijuana, and several comments urged USDA to modify
the IFR to require only that the parts of the plant exceeding the THC
limit be destroyed.
One comment advocated that States be allowed to remediate non-
compliant crops through milling and blending the harvest lot to include
the entire plant to a homogenized state, then retesting the lot. The
comment included the results of a comparative analysis based on crops
that initially tested over the legal threshold of 0.3 percent total THC
during Arizona's 2019-2020 growing season.\25\ According to the
comment, producers opted to attempt remediation as described for a
total of 25 lots representing 568.6 acres of hemp. Of the 25, 19 lots
representing 507 acres successfully reduced the total THC amount to be
compliant, for an 89.71 percent recovery of acres that would otherwise
have required disposal. The comment reported that the average amount of
THC was reduced by 31.61 percent, and suggested that while this
remediation process might not be successful for crops that are
significantly over the legal threshold, and while the market value of
the resulting biomass may be reduced, the process may allow growers to
recover some of their losses.
---------------------------------------------------------------------------
\25\ Caravetta, John: Arizona Department of Agriculture
Additional Comments on USDA Interim Final Rules on Domestic Hemp
Production; https://beta.regulations.gov/comment/AMS-SC-19-0042-5645.
---------------------------------------------------------------------------
One comment \26\ reported on a survey of all Minnesota hemp growers
who had experienced lot failures since the beginning of their pilot
program in 2016. According to the comment, reported losses varied
greatly, ranging between $22,000 and $70,000 per year. The comment
further described the State's analysis of 1,492 hemp lot samples from
2016 through September 2020, which showed that 10.3 percent tested at
or above 4.0 percent total delta-9 THC, although there was no
indication of non-compliance with program rules or of illegal drug
activity on the part of growers. The comment recommended that States
and Tribes be allowed to develop remediation plans to salvage non-
compliant crops.
---------------------------------------------------------------------------
\26\ Petersen, Thom: Minnesota Department of Agriculture
Comments on USDA Interim Rule: Establishment of a Domestic Hemp
Production Program; https://beta.regulations.gov/comment/AMS-SC-19-0042-5548.
---------------------------------------------------------------------------
Post-harvest sampling and retesting: Several comments suggested
retesting post-harvest samples to confirm THC levels. Comments provided
examples of some State agriculture departments that implemented post-
harvest sampling and testing processes under the 2014 Pilot Programs.
For instance, one comment cited results from the 2018 season in which
they allowed post-harvest retesting of hemp plots that originally
tested between 0.4 and 1.0 percent THC. The comment said under Kentucky
rules, farmers were allowed to choose between immediate destruction of
the leaf and floral material of the crop, without additional testing,
or paying the $250 fee for a post-harvest retest of harvested and
ground up hemp material, in which the THC concentration was diluted. It
stated that of 29 growers whose lots tested between 0.4 and 1.0 percent
THC, 22 chose retesting and none of those returned a second measurement
above 0.3999 percent THC. Thus, those growers were able to realize a
return on their investment. The remaining seven cases did not elect to
retest--five elected to destroy the entire plant and 2 destroyed only
floral and leaf materials, salvaging the stalks. The data showed the
acreage destroyed represented approximately one percent of total
acreage. The comment concluded that post-harvest grinding and retesting
offers a viable economic solution for farmers seeking to recuperate
their investment on crops that initially test non-compliant. Other
comments urged USDA to provide for retesting provisions, including
remediation activities, that more favorably support farmers who seek to
salvage crop value. Some of these comments requested that USDA clarify
retesting procedures if a harvest has already occurred.
Statutory implications: Comments from Tribes and other stakeholders
expressed concern that the 2018 Farm Bill only requires ``procedure for
effective disposal,'' and urged USDA to allow producers greater
regulatory leniency as they become familiar with growing a new crop by
permitting alternative remediation methods that do not require crop
destruction.
AMS Response: This final rule covers testing of the hemp plant to
determine acceptable THC levels as required by the 2018 Farm Bill. This
final rule does not cover testing for seeds and stalks individually nor
does it cover processing or the licensing of processors.
As described in the IFR, hemp exceeding the acceptable THC level
may not be further handled, processed, or enter the stream of commerce.
The licensee shall ensure the disposal of the noncompliant crop. Before
such disposal occurs, AMS believes it important and necessary that hemp
growers be provided the opportunity to remediate THC from non-compliant
crops in order to stave off financial risk associated with the loss of
investment in their hemp crop.
AMS agrees with comments that consider remediation as a viable
activity for farmers to minimize crop loss and to salvage the value of
remaining compliant plant material. For this reason, the final rule
provides regulatory flexibility that allows remediation activities--
either disposing of flower materials and salvaging the remainder of the
plant or blending the entire plant into biomass plant material. Through
both forms of remediation, the farmer may be able to minimize losses
and, in some case, produce a return on investment. A guidance document
will be published with this rule to illustrate approved remediation
techniques. USDA will also finalize the guidance document on disposal
techniques.
Additionally, AMS determined that pre-harvest sampling and testing
yield the truest measurement of THC concentration at the point of
harvest. AMS further maintains this position in this final rule. AMS
notes that if the test results show the original THC
[[Page 5643]]
concentration exceeded the Federally allowable limit, the licensee may
request the laboratory retest the pre-harvest sample. This retest would
not entail the use of post-harvest plant material. However, if the
farmer elects to perform remediation activities under a USDA, State or
Tribal plan, an additional sampling and testing of the remediated crop
must occur to determine THC concentration levels. Only those crops
testing below the acceptable hemp THC level limit will be considered
successfully remediated and thus allowed to enter the stream of
commerce. All other remaining non-compliant crops must then be properly
disposed.
AMS believes the inclusion in the final rule of remediation and
post-harvest sampling after remediation provides the additional
flexibility requested by commenters that expressed the need for farmers
to have greater opportunity of success entering the hemp production
industry.
Reverse Distributors
The IFR requires the collection and destruction of noncompliant
material by a person authorized under the CSA to handle marijuana, such
as a DEA-registered reverse distributor, or a duly authorized Federal,
State, or local law enforcement officer or their designee.
Comments: Comments largely opposed the use of DEA-registered
reverse distributors to dispose of noncompliant material. Comments
asserted that many States and producers operating under the 2014 Farm
Bill have implemented policies related to disposal of non-compliant
material that do not require DEA involvement. Comments argued there are
relatively few registered reverse distributors on DEA's 2019 list and
pointed out that some of the major hemp production States have very few
or no registered reverse distributors. Comments claimed existing DEA-
registered reverse distributors haven't the resources or training to
oversee destruction of large plots of agricultural crops in remote
areas, and that such limitations would create a compliance bottleneck.
Comments asked USDA to clarify who would be responsible for paying DEA
reverse distributors for crop disposal services.
One comment asserted that DEA regulations prohibit reverse
distributors from accepting controlled substances from other than DEA
registrants, making it impossible for hemp farmers to release non-
compliant hemp directly to DEA reverse distributors. One comment
suggested that hemp growers could automatically become reverse
distributors if their hemp samples test above acceptable THC levels so
growers could legally manage crop destruction on their own. Another
comment asked whether DEA would allow for a waiver from the current
limitation on reverse distributors to allow reverse distributors to
accept cannabis material for disposal from individuals or entities who
cultivate hemp in accordance with their state's approved plan, but who
do not hold a Schedule I DEA registration.
Numerous other comments expressed concern that alternative law
enforcement agencies (non-DEA) will face the same resource constraints
as the DEA. Comments described how State law enforcement officials are
typically unwilling or unavailable to participate in the disposal of
noncompliant crops and suggested this is due to the lower
prioritization of hemp compliance oversight in light of more pressing
public safety and crime intervention responsibilities. For example, a
comment representing rural counties said this conflict in priorities is
particularly acute in rural areas where resources are already stretched
too thin. The comment asserted that while preventing serious violations
of controlled substances laws is a priority for law enforcement
agencies, hemp with slightly elevated THC levels is unlikely to be sold
as marijuana. The comment advocated formulating hemp disposal
procedures entirely outside the scope of law enforcement. One comment
worried about the stress and stigma on growers having law enforcement
personnel descend upon their farms in connection with hemp disposals.
Other comments supported allowing State regulatory authorities to
oversee or authorize disposal of non-compliant material, asserting that
States can safely and efficiently complete the process at a much lower
cost to producers and States.
Some comments supported disposal of non-compliant material by law
enforcement. Some suggested that States, rather than Federal agencies,
work with State and local law enforcement to handle disposals. One
comment suggested that the definition of ``duly authorized Federal,
State, or local law enforcement officer'' be modified to include
disposal under the authority of State or local law enforcement in order
to address the anticipated increase in required disposals. Finally,
comments from Indian Tribes urged USDA to expand the definition of law
enforcement in the final rule to include Tribal law enforcement.
AMS response: AMS acknowledges the many stakeholders who expressed
through comment concerns about the collection of non-compliant plants
by DEA-registered reverse distributors, or duly authorized Federal,
State, or local law enforcement. AMS notes that law enforcement
policies and priorities are not set by USDA and the 2018 Farm Bill does
not provide this authority. To address public comment, this final rule
will retain disposal requirements stated in the IFR but will further
clarify what ``disposal'' means relative to the role of reverse
distributors.
AMS relaxed the disposal requirements enacted under the IFR in
February 2020. This decision followed consultation with DEA. This
provided growers the added flexibility to conduct on-farm disposal
activities themselves, without required onsite law-enforcement
supervision. Based on positive feedback received from State and Tribal
oversight agencies and producers following the relaxation of disposal
requirements, AMS is permanently allowing for on-farm disposal
flexibility in the final rule.
Under this final rule producers do not need to use a DEA-registered
reverse distributor or law enforcement to dispose of non-compliant
plants (7 CFR 990.3(a)(3)(iii)(E) and 990.27) if the producer disposes
of the plants using one or more of the means described by USDA at
https://www.ams.usda.gov/rules-regulations/hemp/disposal-activities. It
is the agency's intent that these methods allow producers to apply
common on-farm practices as a means of disposal while rendering the
controlled substance non-retrievable or non-ingestible. Producers must
document the disposal of all non-compliant plants in accordance with
Sec. 990.27. Reporting can be accomplished by providing USDA with a
completed: ``USDA Hemp Plan Producer Disposal Form.''
Cannabis with a THC level of over 0.3 percent on a dry weight basis
is a controlled substance, that must be disposed of onsite according to
the disposal methods approved by USDA. The State, Indian Tribe or the
state's department of agriculture wishing to have primary regulatory
responsibility have the responsibility for establishing protocols and
procedures to ensure non-compliant plants are appropriately disposed of
in compliance with applicable State, Tribal, and Federal law. States
and Indian Tribes operating under approved hemp production plans must
notify USDA of any occurrence of non-conforming plants or plant
material and provide the disposal record of those plants and materials
monthly. There is a similar requirement for producers operating under
the USDA plan. Additionally, USDA will conduct
[[Page 5644]]
random audits of licensees to verify hemp is being produced in
accordance with the provisions of the rule.
State and Tribal plans must still include procedures to verify
disposal but would have the additional flexibility to use in-person
verification where deemed necessary or, when practicable, require
producers provide pictures, videos, or other proof of disposal. AMS
believes this decision will further alleviate the strain to oversight
resources and allow State and Tribal authorities to more efficiently
and autonomously monitor hemp production in their jurisdictions.
Additionally, the final rule expands the definition of ``law
enforcement'' to include Tribal law enforcement.
Negligent Violation Threshold
The IFR specified that a producer commits a negligent violation
when a reasonable effort to grow hemp is made and the total THC dry
weight concentration exceeds 0.5 percent.
Supporting an increase of negligent violation threshold: Most
comments that addressed negligent violations opposed the 0.5 percent
total THC threshold in the IFR, and many advocated raising the
threshold to 1.0 percent or higher, offering suggestions ranging
between 0.99 and 5.0 percent total THC. Comments said the 0.5 percent
threshold can be too easily breached by prudent farmers for any number
of environmental or genetic factors that are beyond grower control. One
comment supported the 0.5 percent negligence threshold, and others
noted it but signaled neither support for nor opposition to the
threshold particularly.
Some comments suggested that a 1.0 percent threshold would provide
a safe environment in which both new and veteran farmers can operate
comfortably. Comments in favor of a 1.0 percent negligence threshold
noted that several States and other countries have established a 1.0
percent threshold for their jurisdictions that seems reasonable and
achievable in most situations. A few comments pointed out that a 1.0
percent threshold is relatively low compared to the THC levels in
marijuana, which commenters said typically range from 10 to 15 percent.
Other comments advocated higher thresholds that they claim would give
farmers the peace of mind to continue building an industry that is just
taking off. Finally, one comment asked whether an MU was figured into
the IFR's negligent violation threshold and advocated setting the
threshold at 1.5 percent THC and specifying that that threshold
includes the MU.
A state department of agriculture estimates that 42 licenses would
need to be revoked at 0.5 percent stated in the IFR. They further
estimate that this number would shrink to only about 12 licenses were
the threshold increased to 1.0 percent under the final rule.
A state hemp steering committee commented that a 0.5 percent
threshold will deter the experimentation of different varietals and
that this research is essential to discovering which varietals work
best in different climate zones and soil types as well as for the
development of better genetics.
Another state department of agriculture explained that 13 percent
of the hemp samples taken in 2019 tested over the THC limit. The
average THC level in those failures was 1.07 percent Delta-9 THC post-
decarboxylation. A hemp association within the state agreed with the
commenter's recommendation that the level defined for negligence should
be increased to 1 percent THC.
One comment reported that more than 5.5 percent of the pre-harvest
samples collected under the State's plan in 2019 were found to have a
THC concentration of greater than 0.5 percent. Another comment reported
that 13 percent of hemp samples taken in 2019 tested over the THC
limit. According to the comment, data for all years through September
2020 show that most hemp lot failures occur between 0.4 percent and 1.0
percent THC.
Data submitted with a comment from a State University researcher
showed that 8.5 percent of 3,508 samples tested during 2018-2020
exceeded the IFR's negligent violation threshold of 0.5 percent THC.
The comment said that 65 percent of those would not be considered
negligent violations if the threshold were raised to 1.0 percent.
Framing study results another way, the comment explained that at a
negligence threshold of 0.5 percent, the State would have revoked 42
producer licenses, whereas at a 1.0 percent threshold, the State would
have revoked only 12 licenses, given three negligent violations in a
five-year period, a reduction of 72 percent in revocations by changing
the threshold to 1.0 percent.
One comment reported that based on test results they'd seen this
year, 1.0 or 1.5 percent would be a more appropriate threshold for
negligence, due to the heterogeneity of the plant and the awareness of
the industry.
Implementation timeframe: Some comments suggested that it is too
early in the industry's development to determine a realistic numeric
threshold, and they recommended USDA delay fixing a uniform standard
until the industry has more experience and better understanding of the
relationship between all the hemp production factors. Still other
comments asserted that negligence should not be determined numerically
at all, but by a determination about the farmer's intent. Several
comments said that ``negligence is a state of mind, not a number.''
General comments on 0.5 percent threshold: Several comments argued
USDA arbitrarily determined the 0.5 percent negligence threshold. One
comment asked USDA to provide the research reports used to inform the
selection of the 0.5 percent negligence threshold. Another questioned
whether USDA used test results based on the total THC standard
established in the IFR to set the negligence threshold, since it was
the commenter's experience that producers routinely report difficulty
meeting that standard. One comment reported anecdotally that its farm
sends three samples from the same composite lot sample to three testing
laboratories and gets three different results, which the comment
ascribes to the variation in lab procedures. Another comment said that
there are no established uniform standards for cannabinoid testing,
such that even from reputable labs it will not be entirely clear what
the results mean.
The impact of the 0.5 percent threshold on production: Several
comments said the 0.5 percent negligence threshold in the IFR provided
very little buffer (at 0.2 percent) between the 0.3 percent THC allowed
under the program and the 0.5 percent threshold for determining a
negligible violation. What several comments called a ``safe harbor''
for growers was nevertheless considered too narrow by many, saying that
it left virtually no room for error. Comments argued that requiring
growers to both exercise reasonable care and produce crops with only
0.5 percent THC or less is too stringent a standard and does not really
offer the ``safe harbor'' intended. One comment argued that USDA cannot
provide a ``safe harbor'' for violations of the 0.3 percent THC cap
because that cap is enforced by other Federal and State agencies. A few
comments said that the THC levels in 2014 DEA confiscations averaged
11.84 percent THC and argued that the negligence level under USDA hemp
program rules should be closer to the average DEA culpability level.
A comment from a state department of agriculture used 2019
production and testing data to demonstrate that raising the IFR's
threshold from 0.5 percent to 1.0 percent could theoretically reduce
[[Page 5645]]
the number of its farmers exceeding the negligent violation threshold
by more than 75 percent. Several comments advocated a 2.0 percent
threshold, while others suggested the elimination of the negligence
threshold altogether.
Comments highlighted uncertainty in the genetic variation of hemp
varietals and other factors like weather conditions, soil type, plant
disease, and pest pressures that may further exacerbate the risk of
exceeding the 0.5 percent threshold. As well, comments explained that
hemp plants mature rapidly just before harvest. One commenter described
seeing plants go from 0.18 to 0.62 percent total THC in one week.
Comments suggested that enforcing the 0.5 percent negligence threshold
on growers who truly do not intend to grow marijuana is excessive
penalization when THC levels can change that rapidly. Comments argued
that it is not appropriate to add further penalties to hot crop
destruction. Other comments suggested that administrative and
logistical factors beyond the grower's control, such as bottlenecks in
sampling and testing, can likewise create compliance risks for growers
under the 0.5 percent threshold.
AMS response: Based on these comments, AMS is increasing the
negligent violation to a 1.0 percent threshold. AMS acknowledges that a
lower total THC threshold will result in a higher number of negligent
violations. AMS also understands that factors beyond the control of
farmers may cause an increase in total THC-levels, such as seed
genetic, weather and climate, and may contribute to crops exceeding the
negligent violation threshold. AMS believes that the data provided in
the comments clearly showed that increasing the negligent violation
threshold to 1.0 percent would diminish the risk that producers would
incur negligent violations without adding a greater risk of non-
compliant material reaching channels of commerce.
AMS also reviewed the test results of certified hemp varieties
planted in Kentucky in 2017 and 2018 under its 2014 Farm Bill program.
Kentucky has a certified seed program that it believes will yield hemp.
The plants from the certified varieties tested below 0.8 percent THC
concentration level. Additionally, AMS reviewed the test results of
varieties that were eligible to be cultivated under the Nevada 2014
Farm Bill program in 2018. The plants from those varieties tested below
0.9 percent THC concentration level. Given those test results based on
varieties that those two states believed would yield hemp, AMS
determined that a 1 percent THC concentration level for negligence
would account for the fact that a reasonable reliance on certified or
eligible varieties may still yield a plant that tests above the
acceptable hemp THC level.
The impact of the 0.5 percent threshold on crop research: Comments
described the IFR's 0.5 percent negligent violation threshold as a rate
limiting factor to industry innovation and hemp research. One comment
said that hemp farmers, growing under pilot authorization of the 2014
Farm Bill, routinely planted multiple varieties of hemp to see which
performed best. According to the comment, the low negligence threshold
in the IFR discourages such hemp trialing and innovation because
farmers face greater risk of receiving three negligent violations in
one or two seasons and losing eligibility to grow hemp for another five
years. Comments from research universities found the IFR's negligent
violation provisions unworkable for institutions testing numerous
varieties and production variables each season for the same reason.
Comments suggested a higher threshold for negligent violation would
give industry the regulatory flexibility to conduct research with
reduced risk of violating regulatory requirements.
AMS response: AMS recognizes the violation threshold may
incentivize (or disincentivize) innovation by research institutions and
producers. AMS acknowledges more innovation and research across
industry will bring more stability to stakeholders. The 1.0 percent
negligent violation threshold provides new and existing producers
across States and Indian Tribes additional flexibility to innovate and
research with reduced risk for noncompliance. AMS believes the 1.0
percent threshold incentivizes innovation across industry more so than
a 0.5 percent violation threshold.
Statutory implications: Some comments argued that establishment of
the 0.5 percent negligence threshold in the IFR was arbitrary and
capricious under the APA and asked USDA to provide more information
about how the threshold for negligence was determined. Some comments
asserted that negligence is a well-established legal doctrine, and they
argued that USDA cannot artificially and arbitrarily declare a
threshold for negligence. A couple of comments suggested that putting
farmers on probation, suspending them from program participation, and
requiring them to destroy their crops based on an arbitrary number
rather than on court findings is a violation of due process under the
U.S. Constitution's Fifth Amendment.
AMS response: Congress established the definition of hemp and
defined the threshold of THC concentration at 0.3 percent dry weight.
The statute did not define negligent violation. USDA derived the
definition of negligence from the definition of negligence in Black's
Law Dictionary (10th ed. 2014). USDA set the level of total THC
concentration at 0.5 percent for a negligent violation to establish a
clear buffer so that any crop testing out of compliance would not
automatically trigger a violation. The 0.5 percent was based on data
from three states participating in the 2014 Farm Bill pilot program.
AMS believes raising the negligent violation threshold from 0.5 percent
to 1.0 percent in the final rule provides a greater buffer and reduces
farmers' exposure to risk of violation accrual and license suspension.
Oversight Authority: Several comments suggested the government
should have the ability to determine negligence and culpability based
on facts and circumstances surrounding violations and not solely on a
numeric threshold. Other comments asserted that the 2018 Farm Bill's
language leaves room for an Indian Tribe to apply its own negligence
standard. Similarly, other comments from the industry said that States
should be allowed to evaluate potentially negligent violations of State
plans.
AMS response: With regard to violations and culpability
determination, AMS seeks to establish a regulatory framework that
ensures consistency in oversight activities of hemp production.
Variations of criteria or the use of subjectivity in oversight could
result in bias against or leniency to some hemp farmers simply based on
location. Leaving the decision of what constitutes a negligent
violation to abstract factors rather than objective metrics may result
in differences between States and Indian Tribes. Because farmers may
grow hemp in different locations, and in some cases are subject to
multiple oversight authorities, it is important the thresholds for
violations are consistent across oversight authority jurisdictions to
which the grower is responsible. Having a threshold that is well
established and transparent provides a minimum framework to producers.
In developing the compliance requirements for State and Tribal
plans, USDA recognizes that there may be significant differences across
States and Indian Tribes in how they will administer their respective
hemp programs. Accordingly, if, at a minimum, the requirements of the
2018 Farm Bill and applicable parts of this
[[Page 5646]]
regulation are met, States and Indian Tribes are free to determine
whether or not a licensee under their applicable plan has taken
reasonable steps to comply with plan requirements. As previously
stated, this final rule provides that a producer shall not be subject
to more than one negligent violation per calendar year. State and
Tribal plans may tailor the timing around this requirement to align
with their growing season or other applicable dates.
Financial and business risk: Several comments linked the 0.5
percent THC threshold with a greater likelihood of producers committing
negligent violations, receiving corrective action plans, and even
committing culpable negligent violations. Comments stressed that a low
negligence threshold puts farmers at higher risk of accumulating
negligent violations, even when growers take reasonably prudent steps
to mitigate against the production of noncompliant plants. According to
comments, this, in addition to the loss of the crop, jeopardizes
farmers' access to crop insurance and business loans.
Comments addressed the negative impact of the accrual of negligent
violations on the financial stability of the individual business. They
described how a hemp grower's access to credit and insurance is
jeopardized when negligent violations accumulate and lead to a
determination of culpable negligence. Comments explained that lending
institutions and insurance providers look for risk factors. They also
raised questions about how the accrual of negligent violations may be
interpreted by lender or providers. Comments said that many insurers
will not cover crop losses if losses are due to the growers'
negligence. Commenters implored USDA to explain how violations can lead
to determinations of culpable negligence and to provide guidance about
how a reasonable farmer can avoid growing noncompliant hemp.
AMS response: AMS acknowledges institutional lenders view
violations as risk factors in decision making. AMS also notes that not
all culpable violations are derived from the accrual of negligent
violations. Culpable violations may be the result of producers
violating other parts of the 2018 Farm Bill. However, the 2018 Farm
Bill explicitly considers certain actions as constituting negligent
violations. AMS's intention is to provide a threshold between 0.3
percent THC level and what would be considered a negligent violation so
not all hemp that tests over the 0.3 percent be considered a negligent
violation. Because a producer will not have committed a negligent
violation every time he or she grows hemp with a concentration of hemp
above the 0.3 percent level, this will assist producers when requesting
loans or other financial assistance. AMS will provide risk mitigation
activities such as remediation and disposal provisions as well as
increasing the negligent violation threshold to 1.0 percent to diminish
the number of violations that are considered negligent.
Some producers have more than one field or farm in a state or
across state boundaries. Assigning more than one negligent violation
might be detrimental to these producers. For example, if a producer
uses the same seed in multiple locations, and that seed results in a
THC level over 0.3 percent, all of that production must be disposed or
remediated. All of these locations could be determined a separate
violation. However, AMS wants to clarify that a producer may not be
found to have committed more than one negligent violation per year.
Barriers to entry: Several comments suggested that a 0.5 percent
negligence threshold threatens the survival of farmers in an emerging
industry. Comments suggested that the low threshold is a barrier to
entry for new farmers or farmers with no experience growing hemp, who
risk high initial capital investments to establish operations. Comments
argued that the low threshold favors larger farms using industrialized
hemp varieties and production practices, and that the low negligence
threshold in the IFR would unnecessarily criminalize farmers working
with a legal agricultural commodity.
AMS response: All persons interested in growing hemp must meet the
eligibility criteria established in the 2018 Farm Bill and this final
rule. Negligent violations document instances when the statue or rule
are violated such as when a grower fails to report a legal description
of land on which hemp is grown or fails to dispose of a noncompliant
crop. All farmers, regardless of the size of their operations, face the
same set of requirements. Even though the 2018 Farm Bill sets the THC
concentration level at 0.3 percent, it does not define what THC level
in cannabis will give rise to a negligent violation. Left undefined,
this lack of definition is troublesome as it could make enforcement
uneven among States and Indian Tribes. The IFR provided that hemp
producers do not commit a negligent violation if they make reasonable
efforts to grow hemp and the marijuana does not have a THC
concentration of more than 0.5 percent. Increasing this threshold to
1.0 percent benefits producers, including small and new farmers, that
intended to grow hemp but whose crops tested ``hot'' even though they
made reasonable efforts to grow hemp.
Resources and enforcement: One State commented that it currently
enforces a 1.0 percent negligence threshold. According to the comment,
lowering the threshold to 0.5 percent would significantly increase the
rate of negligent violations in that State, require more State and
Federal resources to enforce the regulation, and be financially
burdensome to novice farmers. It stated that the 0.5 percent negligence
threshold is lower than the threshold DEA designates as the upper THC
limit for ``inconclusive marijuana/hemp.'' The comment found the IFR's
0.5 percent threshold inconsistent with some laboratories' testing
capabilities and suggests raising the rule's threshold to 1.0 percent.
AMS response: AMS anticipates that the closer the negligent
violation threshold is to 0.3 percent total THC, the greater the
likelihood that oversight authorities issue more negligent violations.
Moreover, whenever a producer commits a negligent violation, the
oversight authorities must also establish a corrective action plan as
required by regulation. AMS believes that increasing the negligent
violation threshold to 1.0 percent would therefore reduce some burden
to oversight authorities by reducing the number of negligent violations
and corrective action plans that oversight authorities must issue and
administer. AMS notes that regardless of the negligent violation
threshold, any crop exceeding the Federal allowable total THC
concentration must be disposed of according to regulatory requirements.
AMS disagrees that the DEA's enforcement program for marijuana should
affect how AMS manages its compliance program for hemp.
State and Tribal Resources
The IFR required States and Tribal governments to certify they have
the resources and personnel to carry out the practices and procedures
of their respective plans. Further, the IFR provided for audits of
State and Tribal plans to include review of the resources and personnel
employed to administer and oversee its approved plan. Finally, the IFR
specified audit reporting requirements and remediation steps for States
and Tribal governments found to be non-compliant with USDA
requirements.
Comments: Comments from many States expressed enthusiasm for
partnering with USDA in the regulation
[[Page 5647]]
of domestic hemp production. The comments were supportive of
establishing a national regulatory framework that would bring clarity
and consistency to the regulation of hemp production across the U.S.
They emphasized that many States have enacted legislation to facilitate
the regulation of hemp production. No comments received from the States
demonstrated a reluctance to work with USDA in establishing
regulations.
The requirement for States and Indian Tribes to certify to USDA
that they have the capacity to administer a domestic hemp program was
not addressed explicitly in any of States' comments. However, many of
the comments from the States and Indian Tribes registered concerns with
some aspects of the IFR. Most of the comments from States and Indian
Tribes delineated areas where the burden of regulatory oversight might
be reduced, or efficiencies realized, by revisions to the regulations.
Several comments expressed concern that State and Tribal
governments would not be able to perform their responsibilities under
the program as currently established. One comment said the lack of
appropriate personnel, training, and protocol would lead to an
untenable backlog in the collection and testing of samples. Many
comments focused on the sheer number of samples that must be collected,
processed, and tested under the program. The shortage of DEA-registered
labs in the States and the new sample collection protocols were also
areas of concern, although that was addressed shortly after the IFR
went into effect with the announcement of enforcement discretion.\27\
Points of potential weakness in the States' and Tribal governments'
implementation of the IFR were raised by many commenters, both
explicitly and in implied remarks. Many of the comments referenced
State and Tribal government infrastructures being strained under the
new regulatory requirements, especially during peak harvest intervals,
and that those factors could contribute to the failure of the States
and Indian Tribes to fulfill their oversight obligations. A number of
comments alluded to the burden of any breakdown in the regulatory
scheme being borne by hemp producers directly, as with samples that are
not timely collected by State inspectors and the samples then testing
``hot'' without any remediation options, or labs that are not able to
process samples due to capacity issues.
---------------------------------------------------------------------------
\27\ https://www.ams.usda.gov/rules-regulations/hemp/enforcement.
---------------------------------------------------------------------------
Numerous comments made recommendations to address the increased
regulatory burden on States and Tribal governments. Many recommended
changing the 15-day post-sample harvest period to 30 days to allow more
time for States and Tribal governments to collect and process samples,
balance workloads, and alleviate potential backlogs. In addition,
several comments contended that the increased sampling requirements in
the proposal (i.e. requiring sampling of every lot) would burden the
process and contribute to delays in growers receiving results. Those
comments recommended revising the sampling protocol (reducing number of
samples required per producer) to help relieve the strain on government
resources. Lastly, comments suggested that allowing labs that are ISO
17025 accredited to process samples, as opposed to only allowing labs
with DEA registration, would enhance the State's ability to provide
validated, accurate, and timely testing.
One commenter said they had talked with a number of States that
expressed strong concerns over the additional burdens as a result of
the IFR. The commenter further stated that some states they are
considering whether to ``opt-out'' of administering a hemp production
plan themselves in favor of USDA administering a plan.
Lastly, one comment stated that if there was a bureaucratic slow
down or insufficient resources on the part of USDA, a farm should be
allowed to have some recourse to be able to harvest. That comment, and
others that were similar in spirit, effectively questioned what
mitigation efforts would be undertaken for producers in the short run
if a State or Indian Tribe ultimately lacks the necessary resources and
personnel to administer its plan and fails to perform the obligations
it certified it could undertake.
AMS Response: The issues raised in these comments are mostly
addressed under other sections in this rule (e.g., 15-day harvest
window, laboratory accreditation). AMS agrees that there are regulatory
burdens of this program, which are discussed in this rule. States and
Indian Tribes have multiple options that would allow producers in their
States or territories to grow hemp. States and Indian Tribes can
develop their own plan, send their producers to grow under the USDA
plan, or States can continue under the 2014 Farm Bill pilot program.
Many States and Indian Tribes assess fees on producers to cover their
expenses for sampling, oversight and other costs of this program. These
options provide producers different alternatives to grow hemp under
different regulatory schemes. Additionally, USDA has decreased the risk
of the regulatory burden on States and Indian Tribes being borne by
hemp producers by addressing various issues commenters identified that
could cause States and Indian Tribes to be unable to timely fulfill
their responsibilities such as by modifying the sampling protocol and
changing the 15-day post-sample harvest period to 30 days. Other
burdens associated with this final rule that the producer must cover
should be considered by producers, as in any agricultural business,
before a decision to grow hemp is made.
Appeals--Denial of Application and Appeal of Test Results
The IFR addressed the denial of applications to grow hemp in Part
V. APPEALS. The IFR also provided an option to appeal test results in
which producers can request that a second test be performed if they
disagree with the first test results.
Comments: A comment recommended that USDA establish a clear
deadline for applicants who wish to appeal the denial of their grower
applications. The comment noted that the IFR already required a State
or Indian Tribe appealing the suspension or revocation of a hemp
production plan to file an appeal ``within the time-period provided in
the letter of notification or within 30 business days from receipt of
the notification, whichever occurs later.'' The commenter noted that no
such similar deadline is identified for applicants who have been denied
USDA hemp grower licenses.
One comment asserted that denials of ``licensure'' may occur for
``whatever reason.'' Two other commenters submitted examples of State
regulatory language from California and Ohio, each of which include
provisions for the denial of applications for license.
Several comments suggested USDA establish an appeals process
through which someone with a felony conviction may demonstrate
completion of appropriate steps to become eligible hemp producers.
AMS response: This rule retains the IFR provision that an applicant
for a USDA hemp production program license may appeal a license denial
to the AMS Administrator. USDA licensees may appeal denials of a
license, renewals, license suspensions, or license revocations to the
AMS Administrator must be submitted in writing and received within 30
days of the receipt of notification of the denial or within the time-
period provided in the letter of notification, whichever occurs later.
State and Tribal plans reviewed and approved by USDA are
[[Page 5648]]
required to include an appeal process for producers to appeal licensure
decisions. In response to the comment that USDA should establish an
appeals process through which someone with a relevant felony conviction
may demonstrate completion of appropriate steps to become eligible hemp
producers, it is important to note that limitations as a result of
relevant felonies are set in the 2018 Farm Bill.
Appeals--Technical
The IFR stated that producers can request a second test be
performed if they disagree or have doubts about the original test
results.
Comments: One comment indicated that if there is a discrepancy
between compliance testing for THC concentration, there needs to be a
process for farmers to appeal. Another comment noted that no
administrative appeal process exists for producers who wish to
challenge a decision they believe adversely affects them, such as test
result. Another commenter cited personal experience with one State
agriculture department and described as ``unfair'' a regulatory system
that does not allow for an appeal process through which a farmer may
contest test results.
AMS response: USDA is maintaining its position that producers under
a USDA plan are able to request a second test be conducted when they do
not agree or have questions about a test result. This rule provides
flexibility to allow States and Indian Tribes to provide for retesting
if the State or Indian Tribe chooses to do so.
Transportation and Shipping Documents
Under the 2018 Farm Bill and the IFR, neither States nor Indian
Tribes may interfere with the transportation of lawfully produced hemp
through States or Tribal territories, even if hemp production is
prohibited within a particular State or Tribal territory. Public
comments related to transporting hemp focused primarily on facilitating
the interstate transportation of hemp.
Interstate commerce: Many comments applauded the IFR's reiteration
of the statutory provision that allows for interstate shipments of
lawfully produced hemp and hemp products without interference by State
or Tribal law enforcement. Some asked USDA to clarify that prohibited
interference includes that from State, Tribal, or Federal law
enforcement, including DEA. Other comments wanted confirmation that
interstate commerce includes entry into and egress from Tribal
territories and that Tribal hemp production licenses be honored for
purposes of interstate commerce transport and commerce.
Commenters stated they had already encountered situations where
States passed temporary regulations conflicting with the 2018 Farm Bill
and impeding interstate commerce. For example, comments noted an Idaho
Executive Order--Transportation of Hemp--issued in 2019, that they
claimed would ``excessively frustrate interstate hemp transportation
and growth of the hemp industry.'' One airline carrier comment
explained that under this Order, ``transporters may have to stop, get
inspected, and be subject to detention each time they cross
jurisdictional boundaries'' and that airlines would avoid carrying hemp
if this issue is not remedied.
Comments from Indian Tribes expressed concern that despite the 2018
Farm Bill, Tribes transporting hemp through States have a bias against
Tribal hemp production. There were suggestions of the use of a USDA
form or stamp authorizing transportation to address these obstacles.
One commenter also requested that USDA provide for recourse for Indian
Tribes that are prohibited from moving hemp through neighboring States.
AMS Response: At this time, USDA recommends that transporters carry
a copy of the producer's license or authorization, as well as any other
information the governing State or Indian Tribe recommends or requires
that will validate that the transporter is transporting legally-grown
hemp. As allowed under the 2018 Farm Bill, States and Indian Tribes can
be more restrictive, which includes possible transportation paperwork
requirements by States or Indian Tribes. USDA is not adding
transportation paperwork requirements to this rule because it does not
have jurisdiction over common carriers or other types of transporters.
Comment: A comment asserted that intrastate commerce of hemp that
does not meet all the requirements of the IFR should remain under the
State's authority, and farmers producing hemp compliant with the 2018
Farm Bill but not the IFR should be allowed to do so, as long as that
hemp is not transported across State lines. The comment advocated for
no Federal preemption, citing to section 297B(a) of the 2018 Farm Bill,
which provides that ``nothing in this subsection preempts or limits any
law of a State or Indian Tribe that (i) regulates the production of
hemp; and (ii) is more stringent than this subtitle.''
AMS Response: The 2018 Farm Bill does not preempt State law
provided that the State adopts a plan that is approved by USDA and the
plan may provide for more stringent requirements. A State has the
responsibility for enforcing the requirements of its plan. Thus, hemp
that is produced under a State's plan should meet the requirements of
the final rule.
Shipping Documentation: Several comments encouraged USDA to
facilitate the unimpeded flow of hemp in interstate commerce by
implementing identity preservation or tracking systems or requiring the
use of standardized shipping labels, packaging, or other documentation
to certify to stakeholders and law enforcement authorities that the
cargo in transport is Federally legal hemp. Comments suggested the use
of USDA-issued stamps or forms that are recognizable, understood, and
accepted by all law enforcement authorities. Several Indian Tribes made
this suggestion because they are concerned about law enforcement
transportation issues, particularly in Idaho, South Dakota, Maine, New
York and Wisconsin. According to comments, such forms could verify that
cargo hemp is compliant with USDA-approved production plans. Other
comments suggested the use of a standardized bill of lading across the
industry that sets out essential information about the shipment for
easy reference by transporters, regulators, processors, and law
enforcement officials to ensure all loads have been lawfully produced
in accordance with Federal, State, or Tribal law. A comment from an
association of county agriculture commissioners and sealers suggested
USDA require the officially certified lab report to accompany shipments
of hemp product during interstate shipment.
Comments suggested various commercial systems for recognizing
legally produced hemp in transport. Other comments asked USDA to devise
a standard documentation system for hemp carriers that would more
easily absolve them of legal liability related to transporting hemp.
Comments recommended that USDA coordinate with the hemp industry;
Federal agencies such as DEA, the Department of Transportation, and the
Department of Justice; and State agencies, including law enforcement
and transportation departments, to develop such documentation.
Some comments additionally recommended adopting specific hemp
packaging and labeling requirements on the basis that they would
support compliance and enforcement tasks. Some comments advised USDA to
provide specific regulations for testing hemp in transit so that such
testing, if
[[Page 5649]]
necessary, be conducted in a standard manner, consistent with the
requirement that all pre-harvest Total THC testing be conducted by DEA-
registered laboratories. Other comments recommended that hemp loads be
sealed to ensure their integrity and mitigate the interference of
illicit products.
Comments advocated that USDA host a central hemp database for
reporting data applicable to all phases of hemp production that would
be ``read only'' to law enforcement, saying such a system would be
particularly beneficial in resolving questions related to interstate
commerce. One comment advocated for the use of a centralized hemp
clearinghouse to capture hemp flower transfer to processors or
manufacturers for CBD extraction, including information on the licensed
producers and receivers of raw materials, the total weight of materials
being transferred, testing certificates indicating THC levels of the
materials being transferred, and other State-mandated criteria, as well
as information on the vehicles being used to transport the materials.
It further recommended USDA evaluate methods to physically identify and
segregate products containing hemp-derived CBD to differentiate
legitimate from potentially illicit products.
AMS response: AMS understands the importance of ensuring safe
passage of hemp across states and Tribal jurisdictions. Section 10114
of the 2018 Farm Bill specifically states that ``Nothing in this title
or an amendment made by this title prohibits the interstate commerce of
hemp.'' USDA issued a memorandum addressing this issue.\28\ Several
States already identified documents to facilitate transportation of
hemp across states. AMS strongly encourages producers of hemp and
carriers providing transportation services to provide the following
documentation accompanying the hemp cargo: Copies of the laboratory
testing report(s), hemp grower license, invoice/bill of lading, and
contact information of buyer and seller. The 2018 Farm Bill does not
provide specific authority to USDA to This final rule does not adopt
any requirement for interstate transportation of hemp. As required by
the 2018 Farm Bill, USDA is developing a database that will share
information about hemp production with law enforcement. The database
will identify the contact information for the producer, a legal
description of the land on which hemp is produced, and status of the
producer's license or other required authorization from the State or
Indian Tribe.
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\28\ Memorandum from Stephen Vaden, Office of General Counsel to
Sonny Perdue, Secretary of Agriculture, Legal Opinion on Certain
Provisions of the Agriculture Improvement Act of 2018 Relating to
Hemp (May 29, 2019).
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``In-Process'' Material
Comments: Several comments mentioned ``in-process material,''
described as material made from otherwise qualifying hemp plant
material, such as crude CBD oil and distillate, or as any hemp material
that is compounded, blended, ground, extracted, sifted, sterilized,
derived by chemical reaction, or processed in any way for use in the
manufacture of hemp products. Commenters asked USDA to clarify that
once hemp has been tested and allowed to enter commerce, it should be
considered legal material thereafter. One comment suggested the
establishment of specifications or guidance for any part in the ``in-
process material'' manufacturing record where control is necessary to
help ensure that specifications are met for the identity, purity,
strength, and composition of the hemp products and, as necessary, for
limits on those types of contamination that may adulterate or may lead
to adulteration of the finished batch of the hemp product.
One comment explained the perception that in-process materials are
not allowed to transfer freely between processors, causing bottlenecks
in product processing. According to the comment, some hemp processors
may be limited to performing only one step of a multi-step process to
derive hemp products, such as distilling CBD oil and isolating the CBD
molecule. It said processor-to-processor transfers of in-process hemp
materials should be authorized between U.S. States with valid hemp
programs, which would open a processing bottleneck and allow both hemp
materials and cash to flow more freely. The comment asserted such
authorization would improve prices for CBD end-products, which would
trickle down to hemp growers.
Some commenters stated that it is commonly known that THC levels in
initially compliant hemp may rise above the 0.3 percent delta-9 THC
limit during subsequent processing. Commenters expressed concern that
some jurisdictions believe the ``in-process material'' should be
diluted to always maintain the level below 0.3 percent delta-9 THC,
even during transportation to another processor. However, several
comments argued that ``in-process material'' is neither consumer ready
nor a ``finished'' product and that dry-weight measurements related to
hemp THC levels are calculated on the initial plant material and not
the finished product to ensure compliance with the threshold.
AMS response: The 2018 Farm Bill directed USDA to establish a
national regulatory framework for hemp production in the U.S., and the
final rule outlines provisions for this mandate. The IFR and this final
rule do not cover hemp or its products beyond production. Further, DEA
has issued regulations covering some of these products or ``in-process
materials''.\29\ Accordingly, this final rule does not address ``in-
process materials,'' processors, end-products, processing of CBD or
other cannabinoids or anything that may contain hemp or hemp
byproducts.
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\29\ https://www.govinfo.gov/content/pkg/FR-2020-08-21/pdf/2020-17356.pdf.
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Equal Treatment for Tribes
Comments: Some commenters said that final rule should provide
Indian Tribes at least as many opportunities regarding hemp production
and regulation as those granted to States and that the final rule
should allow Indian Tribes to catch up quickly with States that have
been allowed to develop production methods and markets under the 2014
Farm Bill provisions.
AMS Response: This final rule does not distinguish between States
and Indian Tribes. USDA recognizes that both State and Tribal
governments have the ability to authorize and to regulate the
production of hemp within their States or territories consistent with
the 2018 Farm Bill and the final rule.
Psychoactive Effects of Cannabinoids
Delta 9 THC or THC is the primary psychoactive component of
cannabis. As mandated by the 2018 Farm Bill, hemp must be verified as
having THC concentration levels of 0.3 percent or below on a dry weight
basis.
Comments: Several comments referenced different studies to support
conflicting positions regarding the psychoactive effects of THC and
used study findings to argue that the IFR's THC limit should be
revised. Many comments cited the ``Defining Hemp: A Fact Sheet'' from
the Congressional Research Service, updated March 22, 2019, that said a
level of about 1 percent THC is considered the threshold for cannabis
to have a psychotropic effect or an intoxicating potential. Other
commenters argued THC levels of 5 percent or more are necessary for
marijuana to have a psychoactive impact or commercial value. Comments
noted that hemp is generally characterized as plants that are low in
delta-9 THC and high in levels of CBD,
[[Page 5650]]
the primary non-psychotropic compound. Many comments stated that
research shows that CBD affects the ability of THC to bind to CB1
receptor in cells, thus blocking the psychoactive effects of THC.
Other comments representing health organizations stated that
research is challenging the widely accepted premise that CBD is not
intoxicating. They further stated that the THC found in CBD products
can be intoxicating and has caused significant and serious consequences
in terms of job loss, health, and exposure to pediatric populations.
Some comments provided personal testimony that while using CBD for
health benefits they had not experienced psychoactive or intoxicating
effects.
Other comments reported that the United Nations standard STR/NAR/40
uses a ratio of ([THC] + [CBN])/[CBD] to determine whether a plant is
likely to have a psychoactive effect.
AMS response: AMS appreciates understanding different views on the
psychoactive effects of THC. However, this topic is outside the scope
of the final rule, and AMS made no revisions to the program based on
these comments. The 2018 Farm Bill defined hemp as having a THC
concentration of 0.3 percent or less. Medicinal use of hemp or CBD is
covered under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ch.
9, sec. 301, et seq. and under the FDA's jurisdiction.
Miscellaneous Comments
Comments: One comment pointed out that the IFR's hemp definition
did not include the application of an MU, but that the definition of
acceptable hemp THC level does. The comment said references to the
definition of hemp should be changed to refer to acceptable hemp THC
level so there is uniformity across the final rule.
AMS Response: USDA has made references to acceptable hemp levels
when appropriate. The acceptable hemp levels include the MU to account
for differences in laboratory conditions or environments. There is no
intention to change the definition of hemp that is stated by the 2018
Farm Bill.
Comments: Another comment recommended improving the clarity of the
final rule by deleting the words ``or THC'' from the definition of
delta-9 THC, as well as deleting the sentence ``For the purposes of
this part, delta-9 THC and THC are interchangeable.'' The comment
further recommended that the definition of Total delta-9 THC be
expanded to clarify that it includes delta-9 THC combined with delta-9
THCA to account for the conversion of delta-9 THCA into delta-9 THC
when the plant material is dried. Finally, the comment recommended that
in all cases where ``THC'' is referenced throughout the final rule
document with no further clarification, ``THC'' should be changed to
``delta-9 THC.'' The comment said these clarifications will be helpful
in administration of the rule.
AMS Response: AMS is adding a definition of ``Total THC'' to
clarify the use of the term in this rule. Total THC accounts for the
conversion of THCA into THC. We believe using THC and delta-9 THC
interchangeably is appropriate.
Comment: One comment claimed that making the IFR effective
immediately gave farmers preparing for imminent harvest no time to
comply with the new testing and threshold requirements, increasing
their risk of producing plants that were legal under the 2014 and 2018
Farm Bill statutes but potentially illegal under the IFR.
AMS response: USDA's decision to make the IFR effective immediately
was to provide a framework for the 2020 growing season. However, States
had the option to continue operating under the 2014 Farm Bill. States
and Indian Tribes were provided time to develop plans on time for their
planting and harvest season.
Comment: USDA should work with other agencies, including DEA and
DOJ, to develop cohesive information and guidance regarding enforcement
related to hemp.
AMS response: AMS has worked with DEA and other agencies in
developing these regulations to assure that the intent of the 2018 Farm
Bill provisions for hemp are met. USDA is responsible for the
regulatory oversight of hemp production and DEA and other law
enforcement agencies are responsible for enforcing the law regarding
marijuana.
Miscellaneous Comments--Out of Scope
In addition to addressing specific provisions of the IFR, comments
also addressed other topics related to the hemp industry.
Comments: One comment advocated the creation of a USDA commodity
checkoff program for one or more categories of hemp (e.g. grain, fiber,
CBD) and recommended that USDA work with hemp industry trade
organizations and stakeholders to administer checkoff funds to support
hemp agronomic and market development. Another comment included a
newsletter item quoting USDA as saying that such a program could be
developed.
One comment asked USDA to support the hemp industry by adding hemp
seed foods to those offered through school lunch and other government
feeding programs.
One comment said that hemp extracts and concentrates and byproducts
from hemp should be afforded the same legal status and protections as
the hemp from which they originated.
One comment suggested that the IFR did not consider compliant hemp
topical products that make up a large portion of the market or other
applications that cannot be inhaled or ingested.
One comment advocated that hemp and CBD should be covered and
protected under the Perishable Agricultural Commodities Act (7 U.S.C.
499 et seq.).
Some comments said farmers should only be allowed to sell hemp to
licensed brokers, handlers, and processors, and not directly to the
public. They further advocated requiring license information to be part
of the documentation that accompanies hemp shipments.
A couple of comments urged USDA to establish good manufacturing
practices for CBD manufacture.
One comment claimed that chemical and seed providers have developed
aggressive tactics which may be used to hamper hemp producers.
One comment requested updating banking regulations to allow banks
to do business with entities whose income is derived from hemp and/or
legal cannabis. Another comment requested an examination on how bonding
could protect hemp farmers against companies and contracts that have
not been honored, causing financial harm to the grower.
One commenter suggested to discontinue the program totally or at
least discontinue the CBD portion because there is too much potential
for abuse and waste of taxpayer dollars. The commenter stated that it
could be okay to continue the coverage for the seed and fiber. They
also stated that USDA should not be in the marijuana business.
AMS received comments on the impact of the current statutory and
regulatory structure on banking and insurance related to hemp
production. Commenters expressed concern that the 0.3 percent THC
ceiling and the required disposal of cannabis testing above 0.3 percent
THC would hinder the ability of hemp producers to obtain insurance,
loans, or other financial services. One commenter also urged AMS to
clarify if the preemption language in section 10114(a) of the 2018 Farm
Bill encompasses interstate banking, financial services, and
[[Page 5651]]
insurance transactions and if USDA intends to supersede, coordinate, or
adopt guidance issued by other Federal agencies related to hemp
production.
A comment suggested banks could offer insurance for crop losses if
the hemp had a THC concentration that was greater than 0.3 percent but
less than or equal to 0.5 percent, similar to offering coverage for
losses due to factors beyond the grower's control, depending on various
USDA culpability findings. Another comment advocated that crop
insurance be available for hot hemp.
A comment stated that Non-Irrigated (NI) acreage should be
uninsurable because good producers who are serious about growing the
crop would not bother with NI acreage. Another comment discussed
establishment of ``Earliest Plant Dates'' (EPD), Late Plant Period
(LPP), and Final Plant Date (FPD), and references sections of what may
be a State or Tribe plan and the difficulty of finding farmers growing
hemp in comparable environments for determining such dates and
insurance coverage. It also recommended developing a Replant
Endorsement (with premium associated) to insure 50 to 75 percent of
seed costs for replant. Finally, a commenter stated that germination
tests should be required before the crop is planted and set a minimum
standard of 85 percent germination--and those under that standard would
be uninsurable. Several commenters argued that USDA should (1) ban hemp
and hemp related products imported into the United States; (2)
establish import limits on the number of clone material; (3) eliminate
all imported hemp and concentrates into the U.S. for the next 2 years,
except for trades to the Canadian marketplace, but exportation must
still be open for our country and product markets outside the United
States; and (4) establish clear rules on how imported hemp and hemp
products will be regulated.
One commenter expressed concern about the current regulation of CBD
as a prescription drug arguing that the prescription-only status for
CBD is unwarranted and will facilitate the illegal market that
continues to exist for these products. One commenter noted that the
regulatory ambiguity resulting from the FDA's lack of guidance on CBD
negatively impacts hemp producers and requires greater clarity.
One commenter raised concerns about the ability of farm workers
seeing U.S. naturalization to be able to participate in hemp production
based on a fear that U.S. Immigration and Customs Enforcement will view
work in hemp production as an ``exclusionary activity'' that would be a
barrier to naturalization.
Several commenters expressed concern regarding hemp production in
close proximity to other agricultural crops. Commenters also expressed
concern regarding drying and processing of hemp near other crops and
residential areas. One commenter suggested that AMS support research on
pollination and drift related to hemp production.
One comment asked USDA to clarify whether section 10114(a) of the
2018 Farm Bill extends to interstate banking, insurance, or financial
services involving hemp and hemp products. According to the comment, it
is not clear whether interstate commerce in hemp and hemp products
necessarily includes the payment for any hemp and hemp products through
various methods, such as wires, checks, automated clearinghouse
transactions, credit card or other financial transactions, including
loan proceeds.
One comment advocated the use of their company's blockchain
technology to address industry and law enforcement concerns about
chain-of-custody in sampling, transporting, and testing hemp.
One comment requested that a clear statement be included in the
final rule that USDA concurs that the exportation of hemp and hemp
products is legal. It noted that the 2018 Farm Bill does not prohibit
exports, and stated, without providing any empirical evidence, that
there is sufficient interest in exporting hemp and hemp products from
the U.S. It also suggested that a dedicated tariff code for hemp and
hemp-derived products be established to facilitate export trade.
AMS Response: These comments all address issues that are beyond the
scope of the rule. This rule only covers the production of hemp. Issues
such as promotion of hemp under a research and promotion program;
adding this product to other programs including feeding programs or
PACA; importing or exporting of hemp; who can produce hemp in the U.S.;
processing the commodity; insurance and banking; research or setting
production boundaries; requirements on further products such as CBD; or
other subjects mentioned above, are not the subject of this rulemaking
or within other USDA or federal, State, Tribal, or private industry
responsibilities and authorities.
Comments on the IFR's Regulatory Analyses
Civil Rights Review
The IFR included a Civil Rights review that found the rule would
not have adverse effects on protected persons or groups, deny them
program benefits, or subject them to discrimination.
Comments: One comment indicated that small farmers face challenges
related to costs of seed. Another commenter associated the destruction
of non-compliant hemp as posing a great risk of economic hardship on
hemp farmers, especially the small minority farmers.
Several comments from Indian Tribes explained that certain
provisions of the IFR, for example laboratory DEA-registration
requirements, the definition of key participants, and Tribal law
enforcement availability, did not sufficiently account for the specific
circumstances and challenges facing Indian Tribes across the nation
such as the remote location of many Indian Tribes, the limited economic
resources of Indian Tribes, and Tribal decision-making structures.
Comments pointed out that this final rule must ensure Tribal civil
regulatory authority to help Tribal nations build and implement
successful plans. Other Tribal comments identified the requirements for
the complete destruction of the plant as, ``disproportionately
economically disastrous for our small Native American farmers,''
explaining that Native American farmers tend to be significantly
smaller and operate on very small margins.
One commenter suggested that AMS reconsider the potential civil
rights implications of this rule on the convicted felons because the
IFR, if unchanged, will have a disproportionate negative impact on both
Black and Latino Americans, who according to DOJ data, represent 38.8
percent and 37.2 percent (respectively) of the total population of
Federally sentenced drug offenders. The commenter compares this data to
the data from U.S. Department of Health and Human Services' rates of
illicit drug use among White Americans (9.5%), Black Americans (10.5%,)
and Latino American (8.8%).
Another commenter claimed that using ``flawed/inaccurate science
with lower standards is a direct example of failing to preserve the
protection of the public at large,'' and ``USDA cannot legally
implement their proposed rules without violating the mission statement
of the agency.''
[[Page 5652]]
AMS response: AMS considered the potential civil rights
implications of this rule on minorities, women, and persons with
disabilities to ensure that no person or group shall be discriminated
against on the basis of race, color, national origin, gender, religion,
age, disability, sexual orientation, marital or family status,
political beliefs, parental status, or protected genetic information.
Additionally, this rule would not deny any persons or groups the
benefits of the program or subject any persons or groups to
discrimination. This rule is neutral and of general applicability.
We also note that some of the burdens or hardship described in the
comments are required by the 2018 Farm Bill. First, the 10-year
ineligibility restriction applicable to persons convicted of a State or
Federal felony is a requirement of the 2018 Farm Bill. Also, as stated
previously the basis for the DEA lab registration is rooted to the
statutory requirements of the Controlled Substances Act, that requires
any laboratory that might potentially handle a controlled substance to
undergo the DEA registration process and thus cannot be eliminated.
Additionally, the 2018 Farm requires effective disposal of non-
compliant plants.
Moreover, AMS conducted a Civil Rights Impact Analysis in
accordance with USDA's Departmental Regulation 4300-004: Civil Rights
Impact Analysis.\30\ AMS's analysis did not find any evidence that the
final rule would adversely or disproportionality impact hemp producers
in protected groups, regions or Tribes as compared to the general
population of hemp producers or State Departments of Agriculture.
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\30\ https://www.ocio.usda.gov/sites/default/files/docs/2012/CRIA%20DR%204300-004-final.pdf.
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Regulatory Impact Analysis
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives when an action
is deemed to have significant impacts. If regulation is necessary, then
agencies must select the action that maximizes net benefits, including
potential economic, environmental, public health and safety effects,
and equity. Executive Order 13771 mandates that agencies provide the
best approximation of total costs associated with a new or repealed
regulation. AMS prepared a Regulatory Impact Analysis (RIA) with the
purpose of accomplishing these objectives.
Comments: Very few comments addressed the RIA specifically, but we
received many comments with information related to assumptions that fed
into the RIA such as percent of hot hemp, testing burdens, lab
registration burdens. AMS addressed these comments in the general
comment section and took into consideration information provided for
the RIA.
One comment acknowledged that USDA's economic analysis was based on
sound and reasonable methodology but said that its expectations were
not confirmed by actual market events in 2019. The commenter compiled
production data provided in other comments in an effort to present a
more current analysis of the hemp market. The comment pointed out that
the RIA underestimated the number of hemp production licenses that
would be issued and hemp acres that would be planted in the 2019
growing season. According to the comment, while the RIA called only for
a doubling of licenses beyond the 2018 benchmark, the actual rate of
licenses increased by 476 percent in 2019. Similarly, the comment
reported actual planted hemp acreage in 2019 to be close to 230,000
acres, well over the 155,000 acres assumed by the RIA. The comment went
on to say that the rate of growth for new licenses outpaced the rate of
growth for consumer sales by 3:1, while the RIA had assumed a 1:1 rate
over the next four years. The comment explained that supply growth has
outstripped demand and created significant market imbalance and, as a
result, market prices have dropped and driven down revenues to hemp
producers.
The comment cited the gross revenue for floral material estimated
in Table 1 of the RIA, which ranges from $2,333 to $24,000 per acre
under the assumption that two-thirds of an acre is planted for floral
material. Based on market data published in November 2019, after the
IFR's publication, the comment suggested that the actual range of gross
revenue for floral material per two-thirds of an acre was $2,728 to
$17,261. The comment then applied the variable cost of planting one
full acre of floral material estimated in the RIA, $28,638 per acre, to
this range of gross revenue. This calculation resulted in a loss of
$11,377 to $25,910 per acre, which the comment said is incorrect given
that the variable cost per acre of floral material was deducted from
the gross revenue per two-thirds of an acre. For an accurate estimate
of net revenue, it stated that gross revenue and costs must be
represented in terms of the same unit of measurement.
The comment suggested that the downstream effects of an unbalanced
economic supply equation would further disrupt the profitability of
sectors that are intended to support the transportation, processing,
and retail sales of the product. It cited sales data reporting a 50
percent decline in the price of CBD extracts and concentrates from
April 2019, stating that the oversupply of hemp has affected the entire
commercial supply chain.
The commenter disagreed with the methodology used to project the
net social benefit of hemp per acre in the IFR, saying that methodology
assumed social benefit is a static figure. The commenter asserted
instead that social benefit is ``a fluid figure that is heavily
influenced by time and supply and demand economics'' and that it will
likely fall over time.\31\
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\31\ https://beta.regulations.gov/comment/AMS-SC-19-0042-1490.
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Further, it argued that the estimated 2019 societal willingness to
pay of $2,650 per acre, which was calculated in the RIA using Kentucky
grower sales and planted acreage, is not representative of the rest of
the United States. Based on the hemp product sales in Chart 1 of the
RIA, the estimated return to producers of processor sales of 31
percent, which was calculated in the RIA by comparing Kentucky grower
and processor sales, and total U.S. planted acres estimated in Table 3
of the RIA, the comment calculates a 2019 national societal willingness
to pay of $2,325 per acre. This result indicates that the societal
willingness to pay based on Kentucky data is 14 percent higher than the
estimate for the United States as a whole. The comment also calculates
a national societal willingness to pay for 2018 of $4,047, which
illustrates that a decline in societal willingness to pay of 42.5
percent occurred in 2019.
The comment cautioned that the net social benefit calculated in the
IFR was over inflated because it represents a point in time during the
industry's infancy. The comment argued that the industry faces a market
depression and recommended a quota system for licensing classified by
intended use. In this recommendation, the comment offered a detailed
approach to estimating acreage required to meet demand for hemp grown
for use in the CBD market. The analysis resulted in an estimated 44,509
acres required to meet demand in 2020, 83,336 acres for 2021, 188,558
acres for 2022, 255,899 acres for 2023, and 309,773 acres for 2024. The
comment expanded upon its recommendation of a quota licensing system,
suggesting that a number of licenses be granted by range of acreage,
thereby ensuring that a share of licenses is reserved for small
farmers.
Another comment asserted that unless the IFR definition of hemp is
revised to include cannabis with a total THC level
[[Page 5653]]
of not more than 1.0 percent on a dry weight basis, it will not be
economically viable to grow hemp for flower in the U.S. According to
the comment, if the THC limits of the IFR are maintained in the final
rule, the RIA should be revised to reflect the impact of the rule on
total yield and CBD concentration of harvestable flowers, reduced value
of CBD hemp seed, and the unknowable market value of CBD. The comment
predicted that although the value of hemp seed for flower might be
reduced marginally, other input costs would remain very high.
One comment recommended differentiation between hemp biomass and
hemp flowers in the IFR's analysis of market prices for floral
material. The comment said that hemp biomass refers to full plant
material, including stems, leaves, and flowers, while hemp flower
refers to the part of the plant that contains trichomes which houses
richly and densely populated cannabinoid content. The comment said the
prices in the RIA are consistent with prices for hemp biomass, and
suggested prices for hemp flowers ranging from $25 to $800 per pound,
depending on the percentage of CBD present.
Two comments asserted that USDA grossly underestimated the sampling
time and cost in the IFR. Comments were concerned that readers might
assume hemp sampling and testing costs fees are preset. The comments
suggested that hemp sampling is a more complex logistical problem than
contemplated in the IFR because of the geography and scope of sampling
on farms. The comments encouraged USDA to calculate anticipated
sampling costs to include a minimum number of hours for each step in
the sampling process, and to consider factors such as travel time and
coordination of supplies and personnel for the sampling effort.
One comment disagreed with the IFR statement that the new hemp
production program would expand production and sales of domestic hemp,
benefitting U.S. growers and consumers. The commenter said that
production costs for his CBD hemp farm were approximately $16,000 per
acre, but because of the IFR's restrictiveness and his resulting
inability to bring the crop to full maturity, the crop would likely
only return $9,000 per acre. The commenter said they were unwilling to
make that kind of risky investment and was unwilling to decide whether
to plan for future crops until USDA finalizes its rule.
AMS response: AMS is aware that the number of licenses and amount
of acreage that were estimated in the RIA of the IFR were
underestimated. Entrance of producers into the market spiked at an
unexpected rate in 2019, driving up acreage along with licenses. AMS
utilized the most current data available to it in its analysis of the
hemp market in the IFR and the final rule.
Regarding the estimate in one comment of net loss ranging from
$11,377 to $25,910 per acre, it is important for gross revenue and
costs to be represented in the same unit of measure for an accurate net
revenue calculation, which, in this case, they are not. The variable
cost per one acre of floral material was deducted from the gross
revenue per two-thirds of one acre of floral material, resulting in a
larger loss than if calculated using the same unit of measurement. AMS
has adjusted the calculation of net revenue in the table below using
the market price data cited by the comment. AMS appreciates the
comment's citation of its sources and utilized similar sources in the
RIA of this final rule.
----------------------------------------------------------------------------------------------------------------
Planted acres Yield Price Gross revenue Variable cost Net revenue
----------------------------------------------------------------------------------------------------------------
Low estimate
----------------------------------------------------------------------------------------------------------------
2/3............................. 1,000 $4.09 $2,727 $19,092 $(16,365)
1............................... 1,000 4.09 4,090 28,638 (24,548)
----------------------------------------------------------------------------------------------------------------
High estimate
----------------------------------------------------------------------------------------------------------------
2/3............................. 1,200 21.58 17,264 19,092 (1,828)
1............................... 1,200 21.58 25,896 28,638 (2,742)
----------------------------------------------------------------------------------------------------------------
Furthermore, AMS understands and appreciates the commenter's
argument that net social benefit andsocietal willingness to pay are
over inflated in the IFR. Due to the relative scarcity of industry
data, AMS made many assumptions in its analysis in the IFR, some of
which were not realized. In order to caution industry stakeholders of
the volatility of the hemp market, however, AMS used variable cost
estimates to calculate net returns to producers, which ranged from a
loss of nearly $17,000 to a gain of $6,240. In the single year since
publication of the IFR, a greater amount of data has become available
to AMS, which allows the analysis in the final rule to rely less on
assumptions that may not be actualized.
AMS only has the authority regarding hemp regulation granted to it
by the 2018 Farm Bill. The recommendations to establish a quota system
for issuing licenses based on intended use and to revise the definition
of hemp such that it includes cannabis with up to 1.0 percent total THC
on a dry weight basis are outside of the authority of USDA. The 2018
Farm Bill provided USDA no authority to regulate production volume.
Additionally, USDA cannot adjust the statutory definition of hemp.
AMS has also reviewed the sampling procedures and costs
characterized in approved state and Tribal plans to better estimate the
time and resultant fees that will be charged to producers for sampling
in the hemp program.
Small Business Impacts
AMS performed a Regulatory Flexibility Analysis (RFA) in
conjunction with the IFR that considered the effects of the rule on
small businesses particularly.
Comments: One organization that represents the views of small
entities stated that small hemp producers have significant startup
costs that affect their ability to be competitive in the hemp industry.
The comment notes that hemp production is labor-intensive and has
licensing and regulatory costs that are not typically incurred by
producers of other agricultural crops. Small entities indicated that
only those businesses with adequate capital and large-scale operations
would be able to survive and comply with the requirements of this rule.
Further, comments conveyed that this rule will raise real barriers to
entry for small and disadvantaged producers and could prevent these
critically important producer groups from even entering the hemp
industry.
Other comments stated that the negative effects of the regulatory
incongruence in the IFR
[[Page 5654]]
disproportionately affect farmers, in particular new and small
farmers--and small or already disadvantaged hemp farmers will face
additional risks if the IFR is not changed.
One comment claimed the 2014 and 2018 Farm Bills presented an
innate prejudice for institutional research, including State
departments of agriculture and institutions of higher education and
this prejudice continued in the IFR. The commenter says this is similar
to the bias of California's draft State plan, where individuals
permitted to be grower or breeders, but the program's compliance
burdens are effectively beyond the reach of most individuals.
Commenters stated that this rule will disrupt small producers who
were successfully producing hemp under prior pilot programs. One
organization reported that hemp producers have stopped growing hemp
altogether until they can be certain about what the requirements for
producing hemp. Comments also reported that some hemp buyers have not
renewed their contracts. Comments stated that several of the provisions
of this rule impose unnecessary burdens on small entities. Comments
suggested that many of the sampling and testing requirements should be
revisited and alternatives should be considered and analyzed to
minimize the burden to small producers. In addition, comments said that
small business are very concerned about the risk of losing their
economic investment due to mandatory disposal, the lack of control over
growing conditions, genetics of neighboring crops, and timing and
precision of the testing.
Comments from State departments of agriculture expressed strong
concern as to the additional burdens they would incur as a result of
the rule. These burdens may be directly passed to small producers in
the form of delayed responses to license applications, renewals, and
appeals; testing backlogs; duplicative reporting requirements; new
license fees; and other programmatic issues.
One comment claimed that, based on six years of administering their
hemp program, many of the most rigid requirements of the IFR are not
only unnecessary, but also likely to have a disproportionately adverse
impact on new farmers and farmers with smaller operations. According to
the comment, these farmers already face great risk in the current
marketplace, and need regulatory help, rather than impediments, in
order to grow and thrive. The comment urged AMS to provide a more
sensible, flexible, and practical regulatory scheme to encourage
industry growth.
AMS response: AMS understands that there is a great deal of
uncertainty in the hemp industry currently and has made efforts to
minimize any burden which may befall producers as a result of this
rule. To that end, USDA is not charging producers any fees for
licensing or collecting any fees from producers to support AMS'
administration of the hemp program. The fee structure developed by
States and Indian Tribes to administer their hemp programs lies outside
of the purview of USDA. On average, AMS anticipates total fees paid by
producers under a State or Tribal Plan to amount to $800 per grower.
This amount includes licensing and other fees intended to generally
fund the operations of States or Tribal Programs. Fees for sampling and
testing, on average, amount to about $300 per lot. The cost for an
annual background check for three key participants is $54. AMS
estimates an annual reporting and recordkeeping burden of $129 per
grower. Altogether, these costs total $1,283 per grower, assuming one
lot requires sampling and testing. This total cost is 0.1 percent of $1
million, which is the largest amount in annual receipts that a grower
may receive to be considered to be a ``small business'' under the Small
Business Size Standards of the U.S. Small Business Administration
(SBA).
In response to comments, AMS has revised its sampling and testing
methodology to allow for performance-based sampling, which should
reduce the burden on all producers, large and small. Section 990.3
details this revised methodology. In addition, AMS has modified its
disposal requirements, and allows for remediation of noncompliant
crops. These remediation options are described in Sec. 990.27.
AMS understands the concerns raised by state departments of
agriculture regarding the requirements of administering a commercial
hemp program. For this reason, AMS has made every effort to provide
States and Indian Tribes flexibility to administer their hemp programs,
including whether they charge for fees or other costs or cover those
expenses from other State or Tribal resources. If the burden for a
State or Indian Tribe to administer its own hemp program remains too
great, however, the State or Indian Tribe may elect to participate in
the Federal plan and allow AMS to administer the program. By providing
this flexibility, USDA believes it is less likely that the burdens on
State and Tribal resources will be passed on to small businesses.
Tribal Matters
The IFR provided that States and Indian Tribes may submit hemp
production plans to USDA for approval. Individual producers from States
or Tribal territories that do not have USDA-approved plans may file
separate applications for hemp production licenses under the general
USDA hemp production plan. Below are several comments and AMS's
responses regarding matters of particular concern to Indian Tribes and
Tribal members.
Comments: Comments said the regulations fail to treat Indian Tribes
on an equal basis with States by repeatedly failing to include the term
``Tribe'' when referring to the State and local jurisdictions.
According to comments, by doing so, the regulations fail to respect
Tribal sovereignty and self-government.
AMS response: USDA agrees that Indian Tribes must be treated the
same as States under the regulations. There were a few occasions where
USDA mistakenly left out ``Tribe'' from the language in the regulation.
USDA is correcting these mistakes in the IFR by revising the language
of the final rule to insert ``Tribe'' after ``State'' in the definition
of Law Enforcement Agency in Sec. 990.1; insert ``Tribe'' after
``State'' in Sec. 990.24(a); and revise Sec. 990.40(d), which
incorrectly referred to ``States and territories of Indian Tribes,'' to
refer to ``States and Indian Tribes''.
Comments: Several comments asserted that USDA should not define
``territory of an Indian Tribe'' and claimed that by doing so, USDA
violates Tribal treaty rights to farm on Tribal territories. Comments
argued that such a definition should be left up to each Indian Tribe.
Further, comments contended that the definition of ``territory of an
Indian Tribe'' at Sec. 990.1 inappropriately refers to a criminal
statute, 18 U.S.C. 1151, to define an Indian Tribe's territory and
regulatory jurisdiction. Other comments supported the use of the Indian
country definition, but asked for the removal of the requirement that
the lands must be within the Indian Tribe's jurisdiction, primarily
because it causes uncertainty as to whether Indian Tribes may regulate
hemp production on non-Indian owned fee lands within a Tribe's
territorial boundaries. Comments also asked that AMS clarify that
States cannot interfere with hemp production within the territory of an
Indian Tribe.
AMS Response: If an Indian Tribe does not assume primary
jurisdiction over the Tribe's Indian territory, USDA has jurisdiction
over the hemp production on an Indian Tribe's
[[Page 5655]]
territory pursuant to the 2018 Farm Bill. USDA, therefore, must know
the limits of its jurisdiction over such Indian territory, just as it
must know its jurisdiction over lands ordinarily within State
jurisdiction.
The IFR defined ``territory of the Indian Tribe'' at 7 CFR 990.1 as
having the same meaning as ``Indian Country'' in 18 U.S.C. 1151. Upon
consideration of comments submitted by Indian Tribes, USDA concurs that
reference to the criminal law definition of Indian country could be
confusing.
Therefore, in the final rule USDA revised the definition of
``territory of the Indian Tribe'' to incorporate language from other
Federal statutes, but without explicitly cross-referencing such
statutes. Specifically, the final rule defines ``territory of the
Indian Tribe'' to mean (a) all land within the limits of any Indian
reservation under the jurisdiction of the United States Government,
notwithstanding the issuance of any patent, including rights-of-way
running through the reservation; (b) all dependent Indian communities
within the borders of the United States whether within the original or
subsequently acquired territory thereof, and whether within or without
the limits of a state; (c) all Indian allotments, the Indian titles to
which have not been extinguished, including rights-of-way running
through the same; and (d) any lands title to which is either held in
trust by the United States for the benefit of any Indian Tribe or
individual or held by any Indian Tribe or individual subject to
restriction by the United States against alienation and over which an
Indian Tribe exercises jurisdiction.
In the 2018 Farm Bill, Congress provided authority for any Indian
Tribe to seek USDA approval to become the primary regulator of hemp
production within the ``territory of the Indian Tribe.'' The 2018 Farm
Bill did not provide a definition of the term territory of the Indian
Tribe, and there is no universally accepted definition of that term, or
similar terms, within the field of Federal Indian law. In describing
jurisdictional boundaries associated with Indian Tribes, various
Federal statutes use several terms, including Indian country, Indian
lands, Federal Indian reservations, and areas within the Indian Tribe's
jurisdiction, among others.
Thus, by its very nature and history, the statutory term
``territory of the Indian Tribe'' is ambiguous. According to the Indian
canon of construction, ``statutes are to be construed liberally in
favor of the Indians, with ambiguous provisions interpreted to their
benefit. . . .'' Montana v. Blackfeet Tribe of Indians, 471 U.S. 759,
766 (1985) (citations omitted). In addition, USDA may address
ambiguities in a statute that it administers, with any reasonable
interpretation of the ambiguous term entitled to judicial deference.
Chevron U.S.A. Inc. v. Nat. Res. Defense Council, Inc., 467 U.S. 837,
842-43 (1984). In this case, Congress provided no indication that the
term ``territory of the Indian Tribe'' should apply more narrowly than
similar terms that have been defined and interpreted in other Federal
statutes and programs. Moreover, a narrow interpretation that excluded
nontribal fee lands within reservations would perpetuate the problem of
checkerboard jurisdiction over lands within Indian reservations, adding
unnecessary confusion and uncertainty to the challenges of implementing
the hemp program in Indian country. Therefore, the USDA includes a
regulatory definition of the term ``territory of the Indian Tribe''
that is based on the definition of Indian country in 18 U.S.C. 1151 and
the definition of Indian lands in the Indian Gaming Regulatory Act, 25
U.S.C. 2703(4).
The definition includes all lands within the limits of any Indian
reservation under the jurisdiction of the United States Government,
notwithstanding the issuance of any patent, which encompasses on-
reservation parcels held in fee simple by non-members of the Indian
Tribe. Similar provisions are found in the criminal jurisdiction
definition of Indian country, 18 U.S.C. 1151; in the Clean Water Act,
33 U.S.C. 1377(h); the Clean Air Act, 42 U.S.C. 7601(d)(2)(B).
The U.S. Environmental Protection Agency (``EPA'') interpreted the
statutes that it administers as providing authority to Indian Tribes
over non-Tribal fee lands within Indian reservations. EPA Final Rule:
Indian Tribes--Air Quality Planning and Management, 63 FR 7254 (Feb.
12, 1998); EPA Interpretive Rule: Revised Interpretation of Clean Water
Act Tribal Provision, 81 FR 30,183 (May 16, 2016). EPA found that the
Clean Water Act and Clean Air Act provided a delegation of authority to
Indian Tribes over non-Tribal fee land within reservations. See Arizona
Public Serv. Co. v. EPA, 211 F.3d 1280 (D.C. Cir. 2000). The agency
found legislative intent and a common-sense reasoning to treat Indian
reservations holistically for purposes of environmental regulation.
Similarly, USDA interprets the 2018 Farm Bill as authorizing Indian
Tribes to become--with USDA's approval of a hemp plan--the primary
regulators of hemp production within their territories, including on
nontribal fee lands within reservations. This authority applies without
regard to the Indian Tribe's ability to demonstrate inherent regulatory
authority over non-Indians under the factors set forth in Montana v.
United States, 450 U.S. 544 (1981). Additionally, this definition will
make clear the area over which USDA will have regulatory authority
including licensing if the Indian Tribe does not have an approved plan
or a plan submitted to USDA for approval.
Comment: Some comments said Indian Tribes did not have the benefit
of operating under the 2014 Farm Bill and, consequently, have not
developed the farming techniques and regulatory systems that States
have. Therefore, according to comments, Indian Tribes should be given a
grace period while they develop best practices.
AMS response: Not all States operated under the 2014 Farm Bill, and
some Indian Tribes did enter into Tribal--State agreements under the
2014 Farm Bill. Therefore, establishing a regulatory grace period for
Indian Tribes only is not workable. Indian Tribes may take advantage of
training and technical assistance offered by the USDA and other
entities to ensure that they implement the best systems possible.
Comments: Some comments claimed that negligent violations by Indian
Tribes under Sec. 990.6 may cause Indian Tribes to be ineligible for
other programs.
AMS response: The 2018 Farm Bill describes three types of negligent
violations under State and Tribal plans. The negligent violations
detailed in Sec. 990.6 are required to be included in State and Tribal
plans pursuant to the 2018 Farm Bill.
Comment: A comment contended that the requirement for a geospatial
site identification at Sec. 990.3(a)(1)(ii) is too expensive for
Indian Tribes, unnecessary, and not readily available. Comments said
the Department of the Interior has land records that could be used to
obtain necessary information.
AMS response: A legal description of the land where hemp is grown
is required by the 2018 Farm Bill. Geospatial location is one form of
meeting such requirement. Producers are required to provide information
to FSA on the geographical location of hemp production. FSA offices
will provide assistance in identifying such location at no cost to
producers.
Comments: Some comments said USDA should conduct more Tribal
consultations and provide USDA and DEA training for hemp producers. One
Indian Tribe requested more time to
[[Page 5656]]
allow Indian Tribes to organize a Tribal Advisory Council of Tribal
Leaders to continue with the development and implementation of federal
hemp policy.
AMS Response: In addition to previous Tribal consultations and
extending and reopening the IFR's comment period, USDA added a
September 2020 Tribal consultation to receive additional information,
particularly from 2020 growing season producers. See the section on
E.O. 13175 Consultation and Coordination with Indian Tribal Governments
in this document for further discussion about the consultations. If
Indian Tribes organize a Tribal Advisory Council of Tribal Leaders,
USDA would appreciate any future feedback. Additionally, USDA is
available to provide technical assistance when requested, including
training. USDA is adding training for sampling to its website.
Comments: Comments said that Indian Tribes and individuals within
the territory of the Indian Tribe should not have to be regulated by
States, but should be able to go directly to USDA for licensing if the
Indian Tribe opts out of developing its own Tribal plan and the Indian
Tribe does not otherwise prohibit hemp production.
AMS Response: Subpart C, the USDA Hemp Production Plan, governs
hemp producers in the absence of a Tribal plan. Therefore, any Indian
Tribes or individuals wishing to produce hemp must comply with those
regulations if not covered under a State or Tribal plan. If an Indian
Tribe decides not to develop its own hemp plan, a producer may directly
apply for a USDA license. States were not delegated authority under the
2018 Farm Bill to regulate hemp production within the territory of an
Indian Tribe.
Comment: Indian Tribes should be allowed to implement their Tribal
preference laws.
AMS Response: Nothing in the IFR or the final rule prevents Indian
Tribes from implementing their Tribal preference laws.
Comment: A comment said that Tribal ordinances and interstate
commerce regulations need to address price gouging in seeds and input.
AMS Response: This comment is outside the scope of this rule.
Comment: A comment said the Bureau of Indian Affairs and USDA
should review 25 CFR part 162 governing agriculture and business leases
to ensure that the hemp regulations here do not conflict with that part
or cause additional regulatory hurdles.
AMS response: 25 CFR part 162 establishes certain requirements for
leasing trust or restricted Indian lands. USDA conferred with the
Department of the Interior, the agency regulating Indian land, and did
not identify any conflicts between the two sets of regulations.
Comment: A comment suggested USDA hire an Indian law expert to
assist with development of the final rule.
AMS response: USDA agreed and hired a consultant with 40 years-
experience as an Indian law attorney to assist with the development of
the final regulations and the review of Tribal plans.
Comment: Comments said the criminal history checks required by the
IFR should be expanded to include the Department of Justice Tribal
Access Program (TAP). According to comments, those using TAP would then
be able to directly access criminal history checks. Comments also said
the regulations need to clarify whether the criminal history check can
be a name check or a finger-print check.
AMS Response: USDA conferred with the DOJ Office of Tribal Justice
and was informed that Indian Tribes can use the TAP program to access
the FBI Identity History Summaries. The FBI Identity History Summaries
may be based on name check or a finger-print check.
Comment: Comments noted that the term ``key participant'' is
defined at Sec. 990.1 in a manner that is not necessarily consistent
with an Indian Tribe's unique organization and methods of doing
business. Comments explained, for example, that an Indian Tribe may be
the owner of a hemp farm. Comments asserted that although the Indian
Tribe's governing council may be the ultimate decision-maker as the
owner, it would not be appropriate to include them in the felony and
background investigations. Therefore, comments said Indian Tribes
should be permitted to identify their own ``key participants'' if they
are operating under a USDA plan and the requirements of Sec. 990.22.
AMS Response: USDA understands the concerns raised by Indian Tribes
regarding the application of the criminal history report requirement
and the felony conviction restriction on Tribal leaders. However, USDA
must ensure that entities operating under a USDA plan comply with the
felony conviction restriction in the AMA. For reasons explained in the
IFR, USDA believes that the appropriate approach in determining who
participates in the program, and therefore subject to the felony
conviction restriction, is to focus on those who exercise executive
managerial control over hemp production. USDA also believes that this
focus should be consistent across the USDA plan regardless of the
person who is applying for a license. For the foregoing reasons, USDA
has clarified the definition of key participants in the final rule to
provide that the definition ``does not include a member of the
leadership of a Tribal government who is acting in their capacity as a
Tribal leader except when that member exercises executive managerial
control over hemp production.'' AMS notes that an Indian Tribe may
adopt its own hemp plans subject to USDA approval. When adopting a hemp
plan, the Indian Tribe can determine who participates in its plan and
will be subject to a criminal history check.
Comment: USDA received a comment that it should affirm Tribal
sovereignty by not allowing other federal agencies, such as the DEA, to
interfere with Tribal hemp remediation.
AMS Response: USDA does not have the authority to control the
actions of other federal agencies acting properly within their
authority.
Comment: USDA received comments that USDA owes a trust
responsibility to Indian Tribes. According to commenters, that trust
responsibility requires acknowledging the unique challenges that Indian
Tribes face including that (1) most tillable land was taken from Indian
Tribes during homesteading; (2) Tribes' participation in the farm
program results in only a 60 percent yield of their non-Indian
counterparts; (3) the finance system is usurious as financiers discount
the value of Tribal assets or refuse to consider them at all; and (4)
American Indian producers will be disproportionately disadvantaged
because their farms are significantly smaller and are generally run
with only one crop by families with small margins.
AMS Response: USDA acknowledges that it has a special government-
to-government relationship with Indian Tribes, and believes that, in
preparing and issuing this final rule it has acted in accordance with
that relationship. In response to concerns regarding the unique
challenges Indian Tribes face, as explained in the Civil Rights Review
of this final rule, AMS conducted a ``Civil Rights Impact Analysis''
and did not find any evidence that the final rule would adversely or
disproportionality impact Indian Tribes or Tribal members producing
hemp as compared to the general population of hemp producers or State
Departments of Agriculture. Indian Tribes may take advantage of
training and technical assistance offered by the USDA to ensure that
they
[[Page 5657]]
implement the best systems possible. Additionally, USDA is available to
provide technical assistance when requested.
State and Tribal vs. Federal Regulation
The preamble of the IFR stated that ``[n]othing preempts or limits
any law of a State or Indian Tribe that regulates the production of
hemp and is more stringent than the provisions in the 2018 Farm Bill.''
Further, Section 297B of the AMA expressly states that it does not
preempt a State or Indian Tribe's ability to adopt more stringent
requirements or to prohibit the production of hemp. This was codified
in the IFR in Sec. 990.3(b)(1), which provides that nothing in the
part preempts or limits any law of a State or Indian Tribe that
regulates the production of hemp and is more stringent than this part
or Subtitle G of the Act.
Comments: Many of the comments received stated that the provisions
of the IFR were more stringent than the regulations of pilot programs
established by States under the authority of the 2014 Farm Bill. In
fact, the majority of all comments received either took exception to
the perceived increase in regulatory requirements for hemp production
under the IFR, or presented recommendations for alternative
requirements under the final rule that would not be as restrictive or
burdensome as the provisions in the IFR.
No comments were received that either affirmed or opposed the
rights of States and Indian Tribes to promulgate more stringent
regulations for their jurisdictions. However, one comment said rather
than using the flexibility allowed in the law to let states develop
sensitive state plans, the IFR had rigid controls not required by law
or correlated to the relatively low-level risk of non-compliant hemp.
The comment further said USDA should establish baseline requirements
but provide States flexibility to consider the dynamics of agricultural
production that depend on farm and field conditions, weather, and the
timing appropriate for planting, harvesting, the varieties being
cultivated and the marketing of crops. Other comments agreed with
recommendations to allow States and Indian Tribes to determine certain
provisions that are not central to the minimum regulatory requirements
of the IFR, such as application windows and reporting.
AMS response: The 2018 Farm Bill expressly preserved the ability
for State and Tribal hemp production plans to establish additional
provisions stricter than the baseline regulations required by the 2018
Farm Bill. These baseline regulations require all State and Tribal
plans to include certain minimum requirements for licensing, sampling,
testing, disposal, and information collection. These requirements could
certainly be considered ``more burdensome'' than certain State hemp
production plans operated under 2014 Farm Bill pilot program
provisions, but they are intended to provide consistency and
transparency among the U.S. hemp industry as it matures. Prior to the
passage of the 2018 Farm Bill, States operating hemp pilot programs
could administer these programs with minimal Federal oversight, and
without baseline requirements around sampling, testing, and other
program requirements because the 2014 Farm Bill programs are for
research. The 2018 Farm Bill established baseline requirements for hemp
production for hemp production across the U.S. regardless of the
purpose of the production.
Preemption
Comment: AMS received comments asserting that the IFR did not abide
by the mandate of the 2018 Farm Bill that there be no preemption of
state or Tribal laws that regulate the production of hemp and are more
stringent than the hemp provisions in the federal statute.
AMS response: Section 297B(a)(3) of the AMA provides that for
States and Indian Tribes with primary regulatory jurisdiction over the
production of hemp, there is no preemption if that State or Indian
Tribe both regulates the production of hemp and that regulation is more
stringent than the 2018 Farm Bill or the implementing regulations.
Thus, the no preemption provision of the 2018 Farm Bill is to make
clear that more stringent requirements are not preempted. AMS finds
that the 2018 Farm Bill requires the implementation of federally
mandated minimum standards, which all jurisdictions must follow,
allowing for certain further restrictions by States and Indian Tribes.
Recordkeeping Requirement
Comment: One commenter argued that the recordkeeping requirements
of the IFR violated the 4th Amendment's prohibition against
unreasonable search and seizure and was ``arbitrary and capricious''
and a violation of the APA.
AMS Response: The 2018 Farm Bill established a hemp production
program in the U.S. subject to oversight from the Secretary of
Agriculture. Part of that congressional mandate is for the Department
of Agriculture to establish a plan by which it collects information
from producers to ensure compliance. While hemp is no longer a Schedule
1 drug, USDA can only make the determination of whether the crop is
legal hemp (which it regulates) or illegal marihuana (which it does not
regulate) through the mechanisms Congress has authorized. Recordkeeping
requirements are paramount to that determination, which is required by
Congress. AMS is retaining the recordkeeping requirements of the IFR.
APA Notice and Comment Concerns
Comment: Some commenters claimed that in issuing an IFR, AMS acted
arbitrarily and capriciously in violation of the APA. Commenters argued
that the good cause statement included in the IFR was not adequate to
support its issuance rather than going through notice and comment
rulemaking.
AMS Response: AMS does not agree with these comments and believes
that there was good cause to issue the IFR. AMS has encouraged public
input on the IFR since its issuance and has provided many opportunities
for public comment.
Criminal Background Checks and Definition of Key Participants
Comment: Several commenters argued that the restrictions on
participation in hemp production for people with criminal convictions
related to a violation of a state or Federal controlled substance law
are not necessary and that hemp should be treated the same as all other
commodities, which do not have similar restrictions. Commenters argued
that there should be an exception for people with disqualifying
criminal convictions who could demonstrate rehabilitation and that this
restriction conflicts with state statutory requirements in some states.
One commenter argued that USDA should conduct all criminal background
checks rather than States or Indian Tribes.
AMS Response: AMS acknowledges various stakeholders' advocacy for
reduced restrictions to entry in hemp production. However, the
restriction on participation-based on a criminal conviction for
violation of a state or Federal law related to controlled substances is
a requirement established by statute and AMS does not have the
authority to change to waive this restriction.
Definition of Key Participants
Comment: Some commenters requested that AMS change the definition
of key participants to more clearly state which individuals within a
business entity would be required to submit a criminal history report.
One commenter requested that AMS align the definition of key
participant with
[[Page 5658]]
the definitions of ``legal entities'' and ``beneficial owners'' in
Department of Treasury regulations. Another commenter suggested that
AMS define who must submit a criminal history report in States and
Indian Tribes that have an approved plan for primary regulatory
authority over hemp in their jurisdiction.
AMS Response: AMS acknowledges various stakeholders' advocacy for a
single definition of ``key participants'' for all hemp producers.
However, AMS will not require that States or Indian Tribes with an
approved plan for primary regulatory authority over the production of
hemp in their jurisdiction adopt the USDA definition of ``key
participants.'' States and Indian Tribes are free to incorporate the
AMS definition of key participants into their plan but they are not
required to do so. They must, however, define who participates in their
plan and, for each license or authorization they issue, must identify
at least one individual who will be subject to a criminal history
check. The Department of Treasury definitions of ``legal entities'' and
``beneficial owners,'' while similar to the definition of ``key
participants'' adopted herein apply broadly to the corporate structure
of a business entity. USDA finds the ``key participant'' definition to
best describe those individuals responsible for compliance with this
program or ``leadership structure of a business entity.''
X. Regulatory Analyses
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Domestic Hemp Production
Program's information collection requirements have been previously
approved by Office of Management and Budget (OMB) and assigned OMB No.
0581-0318. The 60-day public comment period was imbedded in the interim
final rule (IFR) which was published on October 31, 2019, and ended on
December 30, 2019. Because of the very tight timeline for publishing
the IFR, OMB granted conditional emergency approval of these seven
forms on December 3, 2019. The USDA Office of Chief Information Officer
(OCIO) published the 30-day Notice for the three-year renewal at 85 FR
36828 on Thursday, June 18, 2020.
While writing the IFR there was very limited data available to make
the initial burden calculations under the Paperwork Reduction Act
(PRA). Since the IFR was published, USDA has been able to gather much
more accurate data on the number of producers, disposal rates, and time
burdens for completing the forms. Because of this new information, AMS
is updating the burden calculations currently approved by OMB. AMS will
submit an updated Information Collection to align the new calculations
in the FR with the 0581-0318 package.
AMS received over 4,600 comments in the first public comment period
and 1,100 during the second comment period on the overall regulation. A
specific analysis of each topic area in the comment analysis section of
the final rule. AMS did not receive public comments specifically on the
PRA nor on the time burden hour calculations to complete any of the
forms. One comment from the Alabama Department of Agriculture wrote
that 10 minutes for a State or Tribal producer license application was
too low, so that has been increased to 20 minutes.
AMS used an initial estimate of 9,000 total producers for the IFR.
This was based on the limited data from State Departments of
Agriculture and the hemp advocacy group, Vote Hemp. Based on a review
of hemp production data from State Departments of Agriculture, and the
data reporting services from Hemp Benchmarks and Vote Hemp, AMS now
estimates 20,000 producers as a yearly average to use for the purposes
of reporting calculations. These numbers will be updated every three
years. While the current percent of hemp growers licensed under USDA is
drastically smaller than this, AMS assumes approximately 20 percent or
4,000 producers will be licensed under the USDA plan, and the other 80
percent or 16,000 producers licensed under State and Tribal USDA-
approved programs.
The description and function of the seven reporting forms remains
the same from the IFR and initial OMB approval. These forms require
specific information be submitted by States and Tribes operating their
own domestic hemp plans, from producers participating in the USDA Plan,
and from laboratories testing for THC content. Reporting and
recordkeeping burdens reflecting revised reporting hours and the
projected additional producers are described in the following sections.
All time and cost figures have been approximated to the nearest whole
number. The table below explains these changes numerically.
Costs of Reporting and Recordkeeping
The initial estimate of 100 State and Tribal plans remains accurate
since the majority of States and Indian Tribes will have their own
programs. As of the Fall of 2020, USDA has already approved 65
individual State and Tribal programs, with more to come. The amount of
State approved programs will also increase once the 2014 Farm Bill
pilot authority expires and those additional States submit plans.
States and Indian Tribes with approved plans are required to report
certain information to USDA through three Forms: The ``State and Tribal
Hemp Producer Report'', the ``State and Tribal Hemp Disposal Report'',
and the ``State and Tribal Hemp Annual Report''. USDA collects
information from all hemp producers under a State, Tribal or USDA
program through the FSA report form ``Report of Acreage''. USDA
collects information from USDA producers through the ``USDA Producer
Application'', the ``USDA Annual Report'' and the ``USDA Disposal
Report''. Laboratories provide information on the ``Laboratory Test
Report''.
AMS has updated PRA calculations using the Occupational Employment
Statistics Survey of the Bureau of Labor and Statistics \32\ using the
2019 data. The mean hourly wage of a compliance officer, as reported in
May 2019, was $35 per hour. This is the same numerical value as the May
2018 report. Assuming 39 percent of total compensation accounts for
benefits, the total compensation of a compliance officer is $57 per
hour. This $57 per hour will be used throughout the PRA section.
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\32\ https://www.bls.gov/oes/home.htm.
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Respondents: States or Tribes With Approved Plans
AMS initially estimated that the time required for States and
Indian Tribes to fill in the information for each of these forms will
be 20 minutes or 0.33 hours with a 5 minute or 0.08 hours record
keeping burden. This estimate has been updated from 20 minutes to 60
minutes or one hour. The ``State and Tribal Hemp Producer Report'' and
the ``State and Tribal Hemp Disposal Report'' are due to USDA every
month. The ``State and Tribal Hemp Annual Report'' form must be
submitted to USDA once per year. Similar to the other two State and
Tribal forms, the annual time burden was initially 20 minutes but has
been updated to 60 minutes. The time burden for each State and Indian
Tribe to complete and maintain these three forms is now 12 hours for
each monthly form and 1 hour for the annual report, for a total of 25
hours per State and Tribe with an approved plan. Given the estimated
number of approved State and Tribal plans is 100, the total cost is 250
hours and $14,250.
[[Page 5659]]
Respondents: Producers Under State or Tribal Plans (Information Only,
Not Completing the Forms)
The time required of producers to supply the information for the
``State and Tribal Hemp Disposal Report'' and the ``State and Tribal
Hemp Annual Report'' will stay the same at 10 minutes for reporting and
5 minutes for recordkeeping burden for each producer for these two
forms. The ``State and Tribal Hemp Producer Report'' time estimate is
now increased to 20 minutes with a 5 minute record keeping burden for
each producer, per the suggestion from the Alabama Department of
Agriculture.
In the IFR, AMS originally estimated that the majority of States
and Indian Tribes would have three-year producer licenses, and
producers would only submit this information once every three years.
Since approving 60 State and Tribal plans, the majority of State and
Tribal licenses are issued on a yearly basis instead. AMS estimates
that the 16,000 State and Tribal producers will submit license
information each year for State and Tribal programs. In addition to
obtaining a license, all hemp producers are required to prove that they
do not have prior drug related convictions that would disqualify them
from participation in the program. States have some flexibility in what
they require of applicants to make this demonstration. However, for
purposes of this analysis, AMS will use the cost of the FBI Identify
Summary, $18, as a proxy cost for all background reports, and 3 key
participants for each license each year, although if we were to take
into account comments, it is likely there will be more than 3 key
participants each year. In the chart below is a cost breakdown of the
application and background check for producers under a State or Tribal
program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost of Plus burden
FBI Identity Summary Number of Number of Total annual * 3 Key background cost of Total cost
respondents responses resposes participants check ($18) application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost for State and Tribal producers (3 16,000 1.0000 16,000.00 48,000.00 $864,000.00 $379,666.00 $1,243,666.00
key participants every year)...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the IFR, AMS estimated that 20 percent of lots will need to be
disposed even though the current rate of disposal is closer to 12%.
This assumption is based on the increased number of new entrants to the
market who may not be successful in their first year or two. AMS is
introducing a new performance-based method to sampling, which will
decrease the amount of testing and noncompliant tests. Therefore, AMS
estimates that 1,600 lots will be disposed under State and Tribal
programs. The producers under a State or Tribal program will provide
their disposal information to their individual regulatory body. The
States and Indian Tribes will then use that information to complete the
monthly ``State and Tribal Hemp Disposal Report''.
These are just the costs and burden of collecting and maintain the
information associated with the disposal, not the actual disposal. The
actual cost of disposing of the non-compliant ``hot'' hemp is discussed
in the RIA.
In total, producers under a State or Tribal program provide
information and hold records for three forms. The total time burden for
these producers providing and maintaining this information is estimated
at 11,061 total hours and $630,466.
Respondents: Producers Participating in the USDA Plan
To produce hemp under the USDA Plan, a producer, which may be an
individual producer or a business, completes the ``USDA Hemp Plan
Producer Licensing Application'' and an FBI Identity Summary. If all
parts of the application and summary are valid, AMS issues a license.
The total burden per respondent of this form will maintain the same as
in the IFR; 10 minutes for the time and 5 minutes for record keeping
for a total of 15 minutes, or .25 hours. Licenses under the USDA Plan
must be renewed every three years, so each producer only submits this
information once every three years. In the IFR, AMS initially estimated
that there will be 1,000 participants in the USDA Plan. AMS has now
updated this estimate to be 20 percent of the total hemp producers, or
4,000 producers each year. Because the USDA license is valid for three
years, approximately 1,332 producers will complete this form each year.
The total annual burden for this form is 544 hours and $31,603.
In addition to the ``USDA Hemp Plan Producer Licensing
Application'' submitted once every three years, producers must submit
criminal history reports for each of their key participants. AMS
estimates each producer to have three key participants submit criminal
history reports to USDA. The cost of a criminal history report is $18
apiece, so three key participates would cost $54 per participant. As
stated previously, AMS estimates that it will receive 1,332 license
renewals in each year. Each of these 1,332 renewals will include a
background summary for three key participates. Adding the cost of 1,332
renewals at $71,928 with the cost of the background check is $31,603
for the renewals and means there is an annual cost of $103,531.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Cost of Plus burden
FBI Identity Summary Number of responses per Total annual * 3 Key background cost of Total cost
respondents respondents resposes participants check ($18) application
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost for USDA producers (3 key 4,000 0.3330 1,332.00 3,996.00 $71,928.00 $31,603.00 $103,531.00
participants every three years)........
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 5660]]
Similar to the required annual report submitted by States and
Indian Tribes to USDA, producers operating under the USDA Plan must
submit the ``USDA Hemp Plan Producer Annual Report'' to USDA each year.
AMS estimates the time burden of submitting this form will maintain the
same, at 25 minutes, or 0.42 hours, per respondent. AMS has updated the
initial estimate of 1,000 participants in the USDA Plan, to 4,000
producers. Therefore, the total burden of this form has increased from
416 hours to 1,665 hours, costing $94,916 annually.
When a hemp sample tests above the acceptable hemp THC level, the
material from the specific lot must be disposed. The producer and
disposal agent must complete the ``USDA Hemp Plan Producer Disposal
Form''. The burden for this form will stay at 25 minutes, or 0.42
hours, per respondent.
Using the same assumptions regarding the prevalence of non-
compliant crops and the costs of disposal that were used in generating
the estimates of hemp disposal reporting (and disposal) for State and
Tribal programs, the 4,000 producers that will participate in the USDA
Plan will generate 400 samples that test high for THC content. The
total reporting burden of this form will amount to 167 hours and cost
$9,492 annually.
Altogether, the annual burden for the USDA producers completing and
maintain the three USDA forms ``USDA Hemp Plan Producer Licensing
Application'', the ``USDA Hemp Plan Producer Disposal Form'', and the
``USDA Hemp Plan Producer Annual Report'' amounts to an annual total of
2,386 hours and a cost of $136,011.
Respondents: Laboratories
The 2018 Farm Bill requires that all domestically produced hemp be
tested for total THC content on a dry-weight basis, whether produced
under a State or Tribal Plan or the USDA Plan. Using data from FSA the
initial estimate of two lots of hemp per producer remains accurate.
However, the new performance-based sampling process will decrease the
number of total samples that are collected and tested.
AMS requires all laboratories testing hemp for THC to submit all
test results, whether passing or failing, via the ``Laboratory Test
Results Report''. AMS maintains the estimated reporting and
recordkeeping burden for this form at 35 minutes, or .58 hours. AMS
originally estimated that 7,700 total hemp producers would submit
15,400 samples to test. AMS has updated this estimate to 8,000 total
tests annually. Therefore, the total annual burden of these tests and
the accompanying ``Laboratory Test Results Report'' form decreased from
8,399 hours to 4,664 hours, and costs $265,848.
Respondents: All Producers
The FSA collects information on crop acreage through the ``Report
of Acreage'' form. Hemp producers under all plans are required to fill
in the information for this form once they receive their license or
authorization from USDA, a State, or Indian Tribe and have planted the
crop. AMS will keep the initial reporting burden and record keeping
burden at 35 minutes, or 0.58 hours. AMS has added 60 minutes or one
hour for the travel time to and from the FSA office, for a total of 90
minutes. With the increased number of producers and the addition of
travel time, AMS estimates the burden for the 20,000 producers will be
31,660 hours and cost $1,804,620.
Total Reporting and Recordkeeping Costs for All Respondents
Altogether, the annual burden for reporting and recordkeeping for
all respondents is 52,296 hours, costing a total of $2,980,864 per
year. This is the sum of the annual burden of reporting and
recordkeeping to States and Indian Tribes operating their own plans, to
producers participating in the State and Tribal Plans, to producers
participating in the USDA Plan, including the cost of a criminal
history report for three key participants, and to laboratories testing
samples for THC content.
[[Page 5661]]
Table
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total Annual hours
Name Form Number of responses per Total annual Hours per reporting Number of per record Total record Total hours x $57
respondents respondent responses response hours record keepers keeper keeping hours
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State and tribal forms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
State and Tribal Hemp Producer Report AMS-23........................ 100 12.0000 1,200.00 0.3333 399.96 100 0.083 8.30 408.26 $23,270.82
(Old).
State and Tribal Hemp Producer Report AMS-23........................ 100 12.0000 1,200.00 1.0000 1,200.00 100 0.083 8.30 1,208.30 68,873.10
(Update).
State and Tribal Producer Responses information only.............. 8,000 0.3330 2,664.00 0.1670 444.89 2,664.00 0.083 221.11 666.00 37,962.00
(Old).
State and Tribal Producer Responses information only.............. 16,000 1.0000 16,000.00 0.3333 5,332.80 16,000 0.083 1,328.00 6,660.80 379,665.60
(Update).
State and Tribal Hemp Disposal Report AMS-24........................ 100 12.0000 1,200.00 0.3333 399.96 100 0.083 8.30 408.26 23,270.82
(Old).
State and Tribal Hemp Disposal Report AMS-24........................ 100 12.0000 1,200.00 1.0000 1,200.00 100 0.083 8.30 1,208.30 68,873.10
(Update).
State and Tribal Producer Disposal information only.............. 2,680 1.0000 2,680.00 0.1670 447.56 2,680 0.083 222.44 670.00 38,190.00
Responses (20% then x 2 for 2 lots/
producer) (Old).
State and Tribal Producer Disposal information only.............. 1,600 1.0000 1,600.00 0.1670 267.20 1,600 0.083 132.80 400.00 22,800.00
Responses (25% of lot from 80% of
producers) (Update).
State and Tribal Hemp Annual Report AMS-25........................ 100 1.0000 100.00 0.3333 33.33 100 0.083 8.30 41.63 2,372.91
(Old).
State and Tribal Hemp Annual Report AMS-25........................ 100 1.0000 100.00 1.0000 100.00 100 0.083 8.30 108.30 6,173.10
(Update).
State and Tribal Hemp Annual Report information only.............. 6,700 1.0000 6,700.00 0.1670 1,118.90 6,700 0.083 556.10 1,675.00 95,475.00
Response (Old).
State and Tribal Hemp Annual Report information only.............. 16,000 1.0000 16,000.00 0.1670 2,672.00 16,000 0.083 1,328.00 4,000.00 228,000.00
Response (Update).
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
USDA Producer Forms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
USDA Hemp Plan Producer Licensing AMS-26........................ 1,000 0.3330 333.00 0.1670 55.61 333 0.083 27.64 83.25 4,745.25
Application (Old).
USDA Hemp Plan Producer Licensing AMS-26........................ 4,000 0.3330 1,332.00 0.1670 222.44 4,000.00 0.083 332.00 554.44 31,603.31
Application (Update).
USDA Hemp Plan Producer Disposal Form AMS-27........................ 400 1.0000 400.00 0.3333 133.32 400 0.083 33.20 166.52 9,491.64
(20% x 2 lots for 2 lots/producer)
(Old).
USDA Hemp Plan Producer Disposal Form AMS-27........................ 400 1.0000 400.00 0.3333 133.32 400 0.083 33.20 166.52 9,491.64
(25% x lots from 20% of all producers)
(Update).
[[Page 5662]]
USDA Hemp Plan Producer Annual Report AMS-28........................ 1,000 1.0000 1,000.00 0.3333 333.30 1,000 0.083 83.00 416.30 23,729.10
(Old).
USDA Hemp Plan Producer Annual Report AMS-28........................ 4,000 1.0000 4,000.00 0.3333 1,333.20 4,000 0.083 332.00 1,665.20 94,916.40
(Update).
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
All Producer Forms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Report of Acreage (Old)................. FSA-578....................... 7,700 1.0000 7,700.00 0.5000 3,850.00 7,700 0.083 639.10 4,489.10 255,878.70
Report of Acreage (Update + 60 min FSA-578....................... 20,000 1.0000 20,000.00 1.5000 30,000.00 20,000 0.083 1,660.00 31,660.00 1,804,620.00
travel time).
Laboratory Test Results Report (2 lots/ AMS-22........................ 7,700 2.0000 15,400.00 0.5000 7,700.00 7,700 0.083 639.10 8,339.10 475,328.70
all producers) (Old).
Laboratory Test Results Report (100% of AMS-22........................ 8,000 1.0000 8,000.00 0.5000 4,000.00 8,000 0.083 664.00 4,664.00 265,848.00
CBD; 50% of fiber; 50% of grain)
(Update).
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total for Updates................... .............. .............. .............. .............. .............. .............. .............. .............. 52,295.86 2,980,864.25
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Each column is a section of the burden estimate, with the cost of $57 per hour calculated in the last column. Each row represents the old or the new reporting calculations.
[[Page 5663]]
E-Government Act
AMS is committed to complying with the E-Government Act, to promote
the use of the internet and other information technologies to provide
increased opportunities for citizen access to Government information
and services, and for other purposes. We recognize using an electronic
system will promote efficiencies in developing and implementing the new
USDA Domestic Hemp Production Program. Since this is a new program, AMS
is working to make this process as effective and user-friendly as
possible.
Civil Rights Review
AMS has considered the potential civil rights implications of this
rule on minorities, women, and persons with disabilities to ensure that
no person or group shall be discriminated against on the basis of race,
color, national origin, gender, religion, age, disability, sexual
orientation, marital or family status, political beliefs, parental
status, or protected genetic information. This review included persons
that are employees of the entities who are subject to these
regulations. This final rule does not require affected entities to
relocate or alter their operations in ways that could adversely affect
such persons or groups. Further, this rule does not deny any persons or
groups the benefits of the program or subject any persons or groups to
discrimination.
This final rule reflects AMS's response to public comment and input
provided by stakeholders. The final rule provides States and Indian
Tribes the regulatory authority over hemp production in their
jurisdictions. It also establishes a Federal plan for hemp producers
located in States or territories of Indian Tribes that do not have
their own USDA-approved hemp oversight plan. There is no evidence that
the final rule will potentially adversely or disproportionality impact
hemp producers in protected groups, regions or Indian Tribes
differently than the general population of hemp producers or State
Departments of Agriculture.
Executive Order 13132--Federalism
AMS has examined the effects of provisions in this final rule on
the relationship between the Federal Government and the States, as
required by Executive Order 13132 on ``Federalism.'' Our conclusion is
that this rule does have federalism implications because the rule has
substantial and direct effects on States, on the relationship between
the National Government and States, and on the distribution of power
and responsibilities among the various levels of government. The
federalism implications of the rule, however, flow from and are
consistent with the underlying statute. Section 297B of the AMA, 7
U.S.C. 1639p, directs USDA to review and approve State plans that meet
statutory requirements and to audit a State's compliance with its State
plans. Overall, the final rule attempts to balance both the autonomy of
the States with the necessity to create a Federal framework for the
regulation of hemp production.
Section 3(b) of E.O. 13132 recognizes that national action limiting
the policymaking discretion of States will be imposed ``. . . only
where there is constitutional and statutory authority for the action
and the national activity is appropriate in light of the presence of a
problem of national significance.'' Section 297B of the AMA is the
statutory authority underlying the rules for USDA to review, approve,
disapprove, or revoke State plans for hemp production. Until the
passage of the 2018 Farm Bill, hemp was a Schedule I controlled
substance as it fell within the CSA definition of marijuana. When hemp
was exempted from the definition of marijuana as part of the 2018 Farm
Bill, in connection with removing it from that list, Congress
established a national regulatory framework for the production of hemp.
Because cannabis plants with a THC level higher than 0.3 are marijuana
and on the Federal controlled substances list, ensuring that hemp
produced under this program is not marijuana is of national
significance.
In addition to establishing a national regulatory framework for
hemp production, Congress expressly preempted State law with regard to
the interstate transportation of hemp. Section 10114 of the 2018 Farm
Bill States that ``[n]o State or Indian Tribe shall prohibit the
transportation or shipment of hemp or hemp products produced in
accordance with subtitle G of the Agricultural Marketing Act of 1946
(as added by section 10113) through the State or the territory of the
Indian Tribe, as applicable.'' Thus, States and Indian Tribes may not
prevent the movement of hemp through their States or territories even
if they prohibit its production. Congress also expressly preempted a
State's ability to prosecute negligent violations of its plan as a
criminal act in section 297B(e)(2)(c). That preemption is incorporated
into this rule.
Section 3(d)(2) of the E.O. 13132 requires the Federal Government
to defer to the States to establish standards where possible. Section
4(a), however, expressly contemplates preemption when there is a
conflict between exercising State and Federal authority under Federal
statute. Section 297B of the AMA requires State plans to include six
practice and procedures and a certification. It also expressly states
that it does not preempt a State's ability to adopt more stringent
requirements or to prohibit the production of hemp. Section 297D of the
AMA requires USDA to promulgate regulations to implement subtitle G of
the AMA, which includes section 297B. Subpart B of the final rule
repeats those requirements, providing more detail where necessary.
States have wide latitude to develop the required practice and
procedures. Subpart B includes more details on the testing and sampling
of hemp plants to establish a national standard to determine whether
the plants meet the statutory definition of hemp. Likewise, the final
rule requires States to follow DEA requirements for disposal of
marijuana for cannabis plants exceeding the acceptable hemp THC level.
Finally, the final rule also reaffirms that States may adopt more
stringent standards and prohibit hemp production within their
jurisdiction.
Section 6 of E.O. 13132 requires consultation with State officials
in development of the regulations. AMS conducted significant outreach
with State officials including individual meetings, participation in
conferences with State officials, and listening sessions where State
officials from all States were invited. During our consultation with
the States, representatives from various State agencies and offices
expressed the following concerns about sampling and testing procedures.
Most requested that USDA adopt uniform, national requirements to
facilitate the marketing of hemp. Some States advocated that USDA defer
to each State to determine the appropriate procedures for its plan.
USDA recognizes the value of a national standard to promote consistency
while allowing States the flexibility to adopt procedures that fit
their circumstances. As explained above, USDA is adopting performance
standards for sampling and testing. As long as the procedures in the
State plans meet those standards, AMS will find those procedures
acceptable.
As AMS implements this new program, we will continue to consult
with State officials to obtain their feedback on implementation.
Finally, we have considered the cost burden that this rule would
impose on States as discussed in the Regulatory Impact Analysis of this
document.
AMS has assessed this final rule in light of the principles,
criteria, and
[[Page 5664]]
requirements in Executive Order 13132. We conclude that this final
rule: Is not inconsistent with that E.O.; will not impose significant
additional costs and burdens on the States; and will not affect the
ability of the States to discharge traditional State governmental
functions.
Executive Order 13175 Consultation and Coordination With Indian Tribal
Governments
AMS examined the effects of provisions in the final rule on the
relationship between the Federal Government and Tribal governments, as
required by E.O. 13175 on ``Consultation and Coordination with Indian
Tribal Governments.'' We concluded that the final rule does have
substantial direct effects on Tribal governments, on the relationship
between the National Government and Tribal governments, and on the
distribution of power and responsibilities among the various levels of
government. The effects of the rule, however, flow from and are
consistent with the underlying statute. Section 297B of the AMA, 7
U.S.C. 1639p, directs USDA to review and approve Tribal plans that meet
statutory requirements and to audit a Tribal government's compliance
with its Tribal plans. Overall, the final rule attempts to balance both
the autonomy of the Tribal governments with the necessity to create a
Federal framework for the regulation of hemp production.
As with States, Tribal governments will have wide latitude in
adopting procedures including adopting requirements that are more
stringent than the statutory ones. For reasons stated in the federalism
analysis, AMS is adopting national standards for sampling, testing, and
disposal of non-compliant plants that Tribal plans must also
incorporate.
AMS conducted extensive outreach to Tribal governments through
individual discussions with Tribal representatives, by extending the
regulatory comment periods and through the following more formal
consultations.
Tribal Consultation May 2019: On May 1 and 2, 2019, USDA held a
formal Tribal consultation on the 2018 Farm Bill including a session on
hemp production. This consultation occurred at the National Museum of
the American Indian located in Washington DC. In addition to listening
sessions for the general public, USDA hosted a listening session for
Tribal governments following the formal Tribal consultation on May 2,
2019. USDA officials attended meetings with representatives of Tribal
governments. On December 11, 2019, roughly 41 days after the
publication of the domestic hemp production program interim final rule,
USDA held a second formal Tribal consultation. This consultation
provided information on the interim final rule. This consultation
occurred in Las Vegas, Nevada, and attendees included USDA officials,
Tribal leaders, Tribal proxies, non-consulting Tribal members, non-
profit representatives, businesses, law firms, private individuals, and
other government employees. On September 24, 2020, USDA held a third
formal Tribal consultation and provided information on the interim
final rule. This consultation occurred virtually and attendees included
USDA officials, Tribal leaders, Tribal proxies, non-consulting Tribal
members, non-profits representatives, Businesses, law firms, private
individuals, and other government employees.
During the May 2019 consultation, Tribal representatives from
several Tribal Governments expressed their opinions that the 2018 Farm
Bill permitted the USDA Secretary to allow AMS to approve Tribal plans
ahead of issuing regulations of the USDA plan. Indian Tribes stated
that approving hemp plans immediately would allow those Indian Tribes
(and States) with a plan to begin planting for the commercial
production of hemp in 2019. The USDA Secretary released a Notice to
Trade (NTT) on February 27, 2019, to explain that Tribal and State
plans would not be reviewed or approved until AMS finalized regulations
ahead of the 2020 planting season. Additionally, the NTT stated that
until regulations were in place, States, Indian Tribes, and
institutions of higher education could continue operating under
authorities of the 2014 Farm Bill. The 2018 Farm Bill extension of the
2014 authority expired 12 months after USDA had established the plan
and regulations required under the 2018 Farm Bill. Congress extended
this expiration until January 1, 2022. After the May Tribal
consultation, USDA issued a second NTT on May 27, 2019, to clarify that
Tribal governments through the authorities in the 2014 Farm Bill are
permitted to grow industrial hemp for research purposes during the 2019
growing season. USDA appreciates the urgency in which the Indian Tribes
wish to engage in this new economic opportunity. We worked
expeditiously to develop and promulgate the IFR so that States and
Indian Tribes could submit their plans in time for the 2020 season.
Tribal Consultation December 2019: During this consultation Indian
Tribes expressed how some provisions of the interim final rule are too
rigid and that USDA did not consider practical problems and potential
economic harm faced by Indian Tribes under the program.
Indian Tribes requested more extensive Tribal consultation and the
inclusion of other agencies involved in hemp production and
enforcement. In response, USDA extended the public comment date by
thirty additional days to January 29, 2020 and agreed to conduct an
additional consultation after the first growing season. AMS also
reopened the public comment period for thirty days in the Fall of 2020.
Tribal Consultation September 2020: Consultation also occurred on
September 24, 2020.
Based on the comments and consultations received, we made changes
to the final regulations. Although Indian Tribes will still incur costs
in complying with final rule, those costs should be outweighed by the
benefits that the Indian Tribes realize in commercial hemp production
occurring within their territories.
Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. Executive Order 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
The USDA's Office of Tribal Relations (OTR) has assessed the impact
of this rule on Indian tribes and determined, in agreement with AMS,
that this rule has substantial direct tribal implications that require
continued outreach efforts to determine if tribal consultation under
E.O. 13175 is required. Based on AMS outreach efforts to date, OTR does
not believe that tribal consultation is necessary at this time. If a
tribe requests consultation AMS will work with the OTR to ensure
meaningful consultation is provided where changes, additions, and
modifications identified herein are not expressly mandated by Congress.
[[Page 5665]]
Executive Orders 12866, 13563, and 13771
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives when an action
is deemed to have significant impacts. If regulation is necessary, then
agencies must select the action that maximizes net benefits, including
potential economic, environmental, public health and safety effects,
and equity. This rule meets the definition of an economically
significant regulatory action under Executive Order 12866, as it is
likely to result in an annual effect on the economy of $100 million or
more. USDA considers this to be a deregulatory action as it allows the
development of a niche market that cannot exist under the state pilot
programs authorized under the Agricultural Act of 2014 (2014 Farm
Bill). This action finalizes the interim final rule published on
October 31, 2019, that expanded production options and enabled
interested farmers to grow hemp.
Executive Order 13771 mandates that agencies provide the best
approximation of total costs associated with a new or repealed
regulation. AMS has prepared this Regulatory Impact Analysis with the
purpose of accomplishing these objectives. USDA considers this to be a
deregulatory action under Executive Order 13771 as it allows for the
development of a niche market that cannot exist under current
regulation. This rule removes barriers to entry and enables domestic
farmers to grow hemp.
Regulatory Impact Analysis
Regulations must be designed in the most cost-effective manner
possible to obtain the regulatory objective while imposing the least
burden on society. This rule finalizes and updates the interim final
rule that established a national regulatory oversight program for the
production of hemp. This program is necessary to effectuate the mandate
in the Agriculture Improvement Act of 2018, known as the 2018 Farm
Bill, to coordinate State and Tribal government hemp production
regulations with the newly established federal regulations for hemp
production in States and Indian Tribes not regulated by State or Tribal
plans. This program is intended to provide consistency in production,
sampling and testing of hemp product to ensure compliance with the
acceptable hemp THC level.
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform, and is not intended to have retroactive effect. The
discussions on Executive Orders 13132 (Federalism) and 13179
(Consultation and Coordination with Tribal Governments), above, address
the extent to which the rule preempts State law, and the impacts of the
rule to Tribal governments. The discussion above regarding appeals
under new part 990, subpart D, describes the administrative procedures
that must be exhausted prior to a judicial challenge.
Introduction
On October 31, 2019, USDA promulgated an interim final rule
establishing a national program for the production of industrial hemp.
A regulatory analysis was performed in support of that regulation and
published as part of the preamble to that rule. This analysis is
intended to update the previous analysis to reflect additional
information gained through the first year of operation of that program
and to assess whether any of the modifications to the program made in
response to public comment have significant impacts on the estimated
costs or benefits of the final program.
In the IFR, AMS estimated lower and upper bounds to calculate the
total net benefits of the rule to society at large. These net benefits
were calculated for 2020 through 2022 only due to lack of data for
future years. In the IFR, 2020 estimated net benefits ranged from a
loss of nearly $4 million to a gain of $17.6 million; for 2021, a net
benefit of $23 million to $46 million; and, for 2022, a net benefit of
nearly $49 million to $74 million. In this final rule, the estimated
net benefits, as shown in Table 12, are $46 million in 2020; $87
million in 2021; $135 million in 2022; $190 million in 2023; $226
million in 2024; and, $351 million in 2025.
The estimates of net benefits resulting from this final rule differ
from those in the IFR due to a variety of factors. First of these is
the large increase in planted acreage and market entrants in 2019, the
scale of which was unexpected. (There may be other unexpected changes
due to the pandemic, but we cannot estimate those at this time.)
Changes in other variables, as well, contributed to the increase in net
benefits in the final rule over the IFR. A comparison of the variables
that are assumed constant (across years 2020 through 2025) in the IFR
and the final rule is shown in Table 1 below. In the year between
publication of the IFR and this final rule, additional information
regarding the hemp industry has emerged to the benefit of this
analysis. AMS believes that the modifications to the analysis from the
IFR to the final rule represent the state of the hemp industry to the
greatest extent practicable. The modifications in this final rule are
intended to further support the hemp marketplace and provide the
greatest flexibility possible while still ensuring the program complies
with the 2018 Farm Bill.
AMS suspects that this rule, compared to the IFR, will incentivize
participation in the market and allow for more farmers to be
successful. In particular, AMS attributes this to two policies. First,
AMS anticipates that the flexibilities in disposal and remediation of
non-compliant hemp will help minimize the risk to farmers, therefore
increasing participation in the industry. Second, AMS anticipates that
the increased threshold for negligent hemp (from 0.5 percent to 1.0
percent) will also reduce risk to farmers and allow for more
innovation.
AMS received numerous comments providing data on the different
aspects of the hemp industry, that while informative, could not be
incorporated in the RIA due to such factors as they were too regionally
focused, small in sample size, or lacked the depth of data points to be
representative of the national hemp market. An example of this is the
portion of retests performed on hemp samples that initially tested
higher than 0.3 percent THC.
[[Page 5666]]
[GRAPHIC] [TIFF OMITTED] TR19JA21.031
The 2014 Farm Bill defined hemp as the plant Cannabis sativa L. and
any part of that plant with concentrations of THC no greater than 0.3
percent on a dry weight basis. While belonging to the same species as
the plant that produces marijuana, hemp is distinctive from marijuana
in its chemical makeup. The marijuana plant contains high levels of the
cannabinoid delta-9 tetrahydrocannabinol (THC), which is the chemical
that produces psychoactive effects. Hemp may contain no greater than
0.3 percent THC on a dry weight basis.
Prior to the 2014 Farm Bill, hemp had never been designated in a
Federal law as different from cannabis generally. The first regulation
of hemp occurred in 1937 with the Marihuana Tax Act, which required all
producers of the species Cannabis sativa to register with and apply for
a license from the Federal government. The ``Hemp for Victory''
Campaign during World War II promoted production of hemp for rope to be
used by U.S. military forces. At the end of the war, however, the
requirements in the Marihuana Tax Act resumed. In 1970, Congress passed
the Controlled Substances Act, granting the Attorney General the
authority to regulate production of cannabis, including hemp.
The 2014 Farm Bill authorized pilot programs, as permitted by State
law, for hemp cultivation for research purposes to be administered by
academic institutions and State departments of agriculture. By 2019
approximately half of the states had developed such a pilot program.
The research under these pilot programs included market research, which
allowed cultivated hemp to enter the stream of commerce as inputs into
various consumer products. For example, in Kentucky, one of the first
states to enact a pilot program, producer sales to processors totaled
$1.6 million in 2016, $7.5 million in 2017, $17.7 million in 2018, and
$51.3 million in 2019.\33\ Hemp biomass contains concentrations of the
cannabinoid cannabidiol, known as CBD. High prices for hemp harvested
for cannabinoids, relative to those of other agricultural commodities,
have fueled producer interest in hemp production since 2014.
---------------------------------------------------------------------------
\33\ Kentucky Department of Agriculture.
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2018 Farm Bill
The 2018 Farm Bill allowed the production and sale of industrial
hemp either under a State or Tribal program approved by the USDA or
under a Federal license for producers in areas with no approved plan
and no explicit State or Tribal statute prohibiting the production of
hemp. The 2018 Farm Bill explicitly preserved the authority of the U.S.
Food and Drug Administration (FDA) to regulate hemp products under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the
Public Health Service Act (PHS Act). Accordingly, products containing
cannabis and cannabis-derived compounds are subject to the same
authorities and requirements as FDA-regulated products containing any
other substance. The 2018 Farm Bill removed hemp from the list of
controlled substances, decontrolling hemp production in all U.S.
States, territories, and lands belonging to Indian Tribes, unless
prohibited by State or Tribal
[[Page 5667]]
Law. This action eliminates the uncertain legal status at the Federal
level of hemp production and allows the U.S. Department of Agriculture
(USDA) to provide hemp producers with crop insurance programs,
potentially reducing risk to producers and providing easier access to
capital. The statute also prohibits interference in the interstate
transport of hemp by States, including those States that prohibit hemp
production and sales. As a result, hemp producers will have access to
nationwide markets.
Need for Regulation
The rule is necessary to facilitate the domestic cultivation of
hemp for sale into the market for hemp products by creating a set of
minimum standards to ensure that hemp being produced under this program
meets all statutory requirements. The rule establishes minimum
requirements for States and Indian Tribes to obtain program approval
and, for producers operating under the Federal program to obtain a
license and meet operating requirements under that license. Without
these provisions, it would not be possible to grow hemp legally.
Both the declassification of hemp, and the prohibition on
interference with interstate transportation apply to hemp that is grown
under an approved State or Tribal plan, or under a Federal license. As
a result, this regulation facilitates provisions of the 2018 Farm Bill
that would otherwise be self-implementing.
Overview of the Action
The 2018 Farm Bill granted regulatory authority of domestic hemp
production to the State departments of agriculture, Tribal governments,
and USDA. States and Indian Tribes wishing to operate their own
programs must submit to USDA plans that include provisions for
maintaining information regarding the land on which hemp is produced,
for testing the levels of THC, for disposal of plants that do not meet
necessary requirements, and for procedures to ensure compliance with
the requirements of the new part, including background checks of all
key participants. State and Tribal Plans must be approved by USDA. This
rule outlines requirements by which the USDA would approve plans
submitted by States and Tribal governments for oversight of hemp
production. The 2018 Farm Bill also directs USDA to develop a plan for
use by hemp producers in States or Indian Tribes where no State or
Tribal Plan has been approved and that do not prohibit the cultivation
of hemp. These actions will promote consistency in regulations
governing the legal production of hemp across the country.
Baseline Definition
The 2014 Farm Bill authorized hemp research pilot programs to be
administered by states and universities. The 2018 Farm Bill repealed
these pilot programs beginning one year from the publication of a USDA
rule; however, the 2021 Continuing Appropriations Act extended the
authorization of the 2014 pilot programs until January 1, 2022. From
2014 to 2018, planted acreage tripled in every year, reaching nearly
63,500 acres in 2018. In the year following the signing of the 2018
Farm Bill, planted acreage increased by more than 400 percent to
327,600 acres in 2019.\34\ The surge of entrants into the hemp market
in 2019 left many producers with unsold inventory. In Kentucky alone,
more than $100 million of hemp material went unsold due to lack of
buyers in 2019. The large number of entrants into the market in 2019
caused a surplus of hemp production, which in turn caused prices to
fall and revenue losses to producers.
---------------------------------------------------------------------------
\34\ Sources include the following: State Departments of
Agriculture; Vote Hemp. 2016-2019 Crop Reports; and, Mark, Tyler,
Jonathan Shepherd, David Olson, William Snell, Susan Proper, and
Suzanne Thornsbury. February 2020. Economic Viability of Industrial
Hemp in the United States: A Review of State Pilot Programs, EIB-
217, U.S. Department of Agriculture, Economic Research Service.
---------------------------------------------------------------------------
Despite the producer excitement that ensued in 2019 following the
signing of the 2018 Farm Bill, only 17 states opted to participate in
the new hemp programs in time for the 2020 growing season. These 17
states accounted for about 20 percent of the total estimated planted
acreage in 2020. Given the apparent affinity by states for the 2014
pilot programs, AMS assumes that in the absence of the 2018 Farm Bill,
the 2014 Farm Bill pilot programs would have continued indefinitely.
Indeed, the 2014 Farm Bill offered no sunset date for these programs.
In order to capture the impacts of this rule on affected entities, AMS
attributes 20 percent of the estimated planted acreage from 2020
through 2025 to the 2018 Farm Bill and this rule which enables its
prescriptions. This 20 percent reflects the amount of planted acreage
in the 17 states that opted to participate in the 2018 Farm Bill hemp
programs for the 2020 growing season. The 2020 growing season was the
final opportunity for producers to cultivate hemp under the 2014 pilot
programs until the 2021 Continuing Appropriations Act extended the
authorization of the 2014 pilot programs to January 1, 2022. By
enrolling in the new hemp programs, these 17 states expressed a
preference for the hemp programs authorized by the 2018 Farm Bill over
the 2014 Farm Bill pilot programs. The remaining 80 percent of planted
acreage estimated from 2020 through 2025 will be treated as
attributable to the 2014 pilot programs under the assumption that they
would have continued in the absence of the 2018 Farm Bill which
terminated them.
In the interim final rule (IFR), AMS attributed 50 percent of the
growth in producer sales from 2020 through 2022 to the 2018 Farm Bill
and this enabling rule. In deriving this assumption, AMS considered the
rate at which hemp acreage had increased in recent years, the number of
States whose hemp pilot programs produced a crop in recent years, and
the number of States that passed legislation following the signing of
the 2018 Farm Bill in anticipation of this rule's enactment in time for
the 2020 growing season. In the time between publication of the IFR on
October 31, 2019, and the beginning of the 2020 growing season, 17
states representing 20 percent of planted acreage opted to participate
in the hemp programs mandated by the 2018 Farm Bill. This portion of
enrollment is less than AMS anticipated in the IFR.
Affected Entities
As of July 2020, States, Indian Tribes, and USDA had issued 19,121
producer licenses. This figure represents licenses issued in 44 States
and one Tribe. About 70 percent of states reported at the time that
they were still accepting applications, which indicates that the number
of 2020 producer licenses issued is likely to grow. For this reason,
AMS estimates that up to 20,000 producer licenses will be issued in
2020. Based on the slowed pace in growth of producer licenses from 2019
to 2020, AMS assumes an annual growth rate in producer licenses of 10
percent from 2020 through 2025, for the purposes of this analysis. The
result is shown in Table 2. AMS is unaware of any estimates that exist
regarding the number of producer licenses that will be issued in the
coming years; however, the novelty of hemp as a commercial agricultural
commodity, the resolutions of uncertainty surrounding regulations, the
expected growth in demand for existing and new hemp products, and the
effective establishments of State, Tribal, and Federal hemp programs
may
[[Page 5668]]
continue to draw producers into the market.
Table 2--Estimated Projection of Number of Producer Licenses Issued
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Growers........................................... 20,000 22,000 24,200 26,620 29,282 32,210
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources and notes:
2020 figure based on July 2020 National Industrial Hemp Regulators conference call.
2021-2025 figures based on assumed annual growth rate of 10% in producer licenses.
As of the writing of this analysis, three states had opted to
participate in the USDA Federal Plan authorizing producers to cultivate
hemp. These states are Hawaii, Mississippi, and New Hampshire.
Together, they represent more than 300 producers in 2020. The number of
licensed producers participating in the Federal Plan is likely to grow
over time due to both greater entrance of producers into the market in
these three states and additional states, Indian Tribes, and
territories opting to participate in the USDA Plan. At the end of 2020,
less than 2 percent of the total number of producers were licensed by
USDA. The extension of the 2014 pilot programs to 2022, which was
included in the 2021 Continuing Appropriations Act published October 1,
2020, resulted in fewer producers participating in the USDA Plan. Prior
to the extension of the 2014 pilot programs, the portion of
participants under the USDA Plan was about 10 percent of the total
number of 2020 producers, with the expectation for further enrollment.
For the purposes of this analysis, therefore, AMS assumes that 20
percent of the total number of licensed producers will be participants
of the USDA Plan, and the remaining 80 percent will be participants of
a State or Tribal Plan.
In addition to hemp producers, this rule will impact state
departments of agriculture, Tribal governments, and USDA as these
entities will bear the responsibility to ensure that hemp producers
abide by the State and Tribal Plans and the USDA Plan for regulating
hemp. At the time this document was written, more than 40 Indian
Tribes, at least 40 states, and two U.S. territories had plans approved
by USDA or were in the process of submitting plans for USDA approval.
At least three states have opted to participate in the USDA plan, and
one state and one territory await legislation authorizing hemp
production. AMS anticipates receiving further interest in both the
Federal Plan and the plans administered by states, Indian Tribes, and
territories in the coming months when the provisions of the 2014 Farm
Bill expire and States and Tribes start implementing their programs.
For the purposes of this analysis, AMS assumes that 100 states, Indian
Tribes, and territories will administer their own plans in every year
from 2020 through 2025. AMS acknowledges that this number is likely to
change from year to year, depending on market conditions, which affect
the ability of a state, tribe, or territory to manage its own hemp
program. Because AMS has no way to predict future market or state
political conditions, for simplicity, it assumes a constant of 100
states, Indian Tribes, and territories administering their own plans
from 2020 through 2025.
Finally, this rule will impact laboratories that will provide
testing services to producers and program administrators. As of the
writing of this analysis, there were 67 laboratories that test hemp
that are registered with the DEA. USDA is requiring that all samples
tested for THC concentration levels be conducted in DEA-registered
laboratories; however, enforcement of this requirement has been delayed
until December 31, 2022.
Expected Costs and Benefits of the Rule
The 2018 Farm Bill grants authorization for production of hemp to
all states and Indian Tribes, unless prohibited by State or Tribal Law.
This rule enables states, Indian Tribes, and USDA to regulate this
authorization. This rule is expected to generate benefits and costs to
hemp producers, state departments of agriculture, Tribal governments,
USDA, and laboratories. The benefits of this rule are expected to
outweigh the costs, however, and the burden on the impacted entities is
anticipated to be minimal.
Producers
Using figures from Hemp Industry Daily and the Brightfield Group,
AMS estimates retailer sales of hemp products to range from $2.5
billion in 2020 to nearly $17 billion in 2025. Based on price spreads
from farm to consumer, published by the Economic Research Service
(ERS), AMS assumes a pass-through rate of 20 percent from retailer to
producer.\35\ AMS also assumes that import values account for 15
percent of the producer share of retail sales. This estimate was
derived using 2019 and 2020 import data from the Foreign Agricultural
Service (FAS) of USDA. At the time of this analysis, import data for
2020 was only available for the months of January through August. In
order to gauge what total 2020 imports might be, AMS applied to the
figure of total imports for January through August 2020 ($55 million)
the average percentage change that occurred in the four months from
August through December of recent years (40 percent). Applying the
assumptions of 20 percent price pass-through from retailer to producer
and import values of 15 percent of the producer share of retail sales
to the estimates of retailer sales results in estimated total producer
sales of $432 million in 2020 to $2.9 billion in 2025, shown in Table
3.
---------------------------------------------------------------------------
\35\ ERS. Price Spreads from Farm to Consumer. September 2020.
Table 3--Estimated Retailer and Producer Hemp Product Sales
[Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total retailer sales \1\................................ $2,540 $4,485 $6,740 $9,310 $10,995 $16,800
[[Page 5669]]
Producer share of retail sales \2\...................... 508 897 1,348 1,862 2,199 3,360
Imports \3\............................................. 76 135 202 279 330 504
Total producer sales \4\................................ 432 762 1,146 1,583 1,869 2,856
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Retailer sales estimates based on the following stores: 2020-2024 estimates from Hemp & CBD Industry Facebook 2019, Hemp Industry Daily, ``Annual
U.S. Hemp-Derived CBD Retail Sales Estimates.'' Published October 16, 2019. 2025 estimate from Brightfield Group. ``US CBD Market Forecast Reduced Due
to Health Consolidation.'' Published July 31, 2020.
\2\ Product of total retailer sales and 20% share of retail sales passed to producers; estimate of 20% share of retailer prices based on Economic
Research Service publications of ``Price Spreads from Farm to Consumer''.
\3\ Assumes imports account for 15% sales at the producer level; source for assumption is FAS 2015-2019 import data, HTS codes 1207990320 and
5302100000.
\4\ Difference of producer share of retail sales and imports.
The estimates in Table 3 reflect total producer sales in aggregate.
AMS is unaware of any data that currently exists that would indicate
sales by individual producer. Given the varied nature of the hemp
industry, producer sizes are anything but uniform; therefore, AMS has
not attempted to project sales by individual producer as it would
likely result in false conclusions and misleading information.
Similarly, data comparing sales by producers under the 2018 Farm Bill
and what sales under the 2014 Farm Bill may have been in the absence of
the 2018 Farm Bill does not currently exist. Further, AMS believes that
this estimate would not differ greatly given the greater access to
nationwide markets and flexibilities provided to producers under the
2018 Farm Bill.
In addition, AMS acknowledges that raw harvested hemp product may
take years to enter the retail market after it passes through the
supply chain. For instance, product sold at the retail level in 2021
may include hemp that was harvested in 2019. In acknowledging this, AMS
understands that the estimated producer sales for a given year in Table
3 may not represent actual producer sales for that year, but rather,
sales from prior years. AMS is unaware of any data that exists that
would identify when a harvested hemp crop is sold into the retail
market. For the purposes of this analysis, therefore, and for
simplicity, AMS assumes that the producer sales estimated in Table 2
represent sales at the producer level for the same year as the retail
sales from which they are derived.
As discussed in the ``Baseline Definition'' section of this
analysis, AMS estimates that 20 percent of the producer planted acreage
from 2020 through 2025 will be attributable to the 2018 Farm Bill and
this rule which enables its prescriptions. This 20 percent reflects the
amount of planted acreage in the 17 states that opted to participate in
the 2018 Farm Bill hemp programs in time for the 2020 growing season.
The 2020 growing season was the final opportunity for producers to
cultivate hemp under the 2014 pilot programs. By enrolling in the new
hemp programs, these 17 states expressed a preference for the hemp
programs authorized by the 2018 Farm Bill over the 2014 Farm Bill pilot
programs. The remaining 80 percent of producer planted acreage
estimated from 2020 through 2025 will be treated as attributable to the
2014 pilot programs under the assumption that they would have continued
in the absence of the 2018 Farm Bill which terminated them. In Table 4,
AMS has calculated total planted acreage inclusive of all domestic
producers, using the estimates of total producer sales in Table 3 and
assumptions that are stated and cited in the table. From the estimates
of total planted acreage in Table 4, AMS calculated the planted acreage
due to the rule in Table 5, along with the estimate of sales
attributable to the rule. These estimates of sales due to the rule will
be referenced as the benefits of the rule to producers in the
calculation of net benefits in Table 10.
BILLING CODE P
[[Page 5670]]
[GRAPHIC] [TIFF OMITTED] TR19JA21.032
BILLING CODE C
To calculate total planted acreage nationwide in Table 4, from
which planted acreage due to this rule will be estimated in Table 5,
AMS assumed the following to remain constant in each year from 2020
through 2025: Portion of total sales by intended use; yields by
intended use; prices per pound by intended use; portions of harvested
volume sold by intended use; and the portion of planted acreage that is
typically harvested. Using 2019 producer data from the Kentucky
Department of Agriculture, AMS estimates that of total sales of hemp
products, cannabinoids accounts for 99 percent, and fiber and grain
each account for 0.5 percent. Also based on data from the Kentucky
Department of Agriculture, AMS estimates that 65 percent of the
harvested volume of hemp for cannabinoids is sold, 90 percent of hemp
harvested for fiber is sold, and 95 percent of hemp harvested for grain
is sold.\36\ This assumption is also referenced in Table 5. AMS
compared the hemp enterprise budgets published by seven different
academic institutions for yield estimates which
[[Page 5671]]
represent the growing conditions across the country. Aside from these
seven, AMS is unaware of any other hemp enterprise budgets published by
an academic institution.
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\36\ The Kentucky Department of Agriculture is widely recognized
as a reliable source for hemp market data as it has collected data
from its producers since the inception of its hemp program in 2014.
Much of this data is publicly available and was cited by many
commenters.
---------------------------------------------------------------------------
Based on 2019 and 2020 prices published by the Jacobsen, AMS
assumes constant per-pound prices for cannabinoids, fiber, and grain of
$3.90, $0.09, and $0.53, respectively.\37\ AMS acknowledges that prices
are unlikely to remain constant from year to year, particularly for
cannabinoids; however, AMS has considered 68 weeks of cannabinoids
prices in determining its estimate of $3.90 per pound. This price
assumes 6 percent CBD at $0.65 per CBD percentage per pound. Using
these prices and yield estimates, AMS calculated a price per acre for
each intended use of hemp. Finally, the assumption that 75 percent of
planted acreage is harvested was estimated using data from multiple
state departments of agriculture. The assumed constants of the portion
of planted acreage that is harvested, yield by intended use, portion of
harvested volume that is sold, and prices by intended use are also
utilized in Table 5.
---------------------------------------------------------------------------
\37\ The Jacobsen Publishing Company. Weekly hemp prices from
July 2019 through August 2020.
[GRAPHIC] [TIFF OMITTED] TR19JA21.033
[[Page 5672]]
In addition to the assumptions already identified in reference to
Table 4, AMS assumes constant the portion of planted acreage due to the
rule and portions of planted acreage by intended use. As described in
the ``Baseline Definition'' section, AMS assumes that 20 percent of
total planted acreage can be considered as attributable to the rule.
This proportion represents the amount of planted acreage of the states
that had plans approved by USDA for a hemp production program, as
authorized by the 2018 Farm Bill, in time for the 2020 growing season.
The 2020 growing season was the final opportunity for producers to
cultivate hemp under the 2014 pilot programs. By enrolling in the new
hemp programs, these states expressed a preference for the hemp
programs authorized by the 2018 Farm Bill over the 2014 Farm Bill pilot
programs.
The Jacobsen estimated that of total planted acreage in 2020, 80
percent was for cannabinoids, 3 percent was for fiber, and 17 percent
was for grain. AMS acknowledges that planted acreage by intended use is
likely to change from year to year as a result of market conditions.
The portion of acreage intended for cannabinoids has, indeed, decreased
from its levels in 2019, with grain and fiber gaining greater consumer
attention. AMS is unaware of any data that forecasts planted acreage by
intended use in years beyond 2020. For the purposes of this analysis,
and for simplicity, therefore, AMS assumes constant the portions of
planted acreage by intended use as reported for 2020.
To reiterate, AMS is aware that raw hemp product at the producer
level may take years to enter the retail market. The analysis in Tables
4 and 5 is meant to show potential consumer demand for hemp products at
the producer level in years 2020 through 2025, and not necessarily the
producer sales of hemp cultivated in these specific years. These
estimates are sensitive to changes in price. Because planted acreage is
derived from total sales, a change in price causes an inverse change in
the estimate of planted acreage; however, the relationship between
price and sales is, of course, positive.
Many states reported to AMS that the land on which hemp is
currently grown was previously utilized for cultivation of corn. Using
data from the National Agricultural Statistics Service (NASS) on the
production value of corn for grain and acres harvested, AMS determines
a value per harvested acre of corn of $630. This value is a national
average of the three-year period of 2017 through 2019, which are the
most recent years for which data is available.\38\ For the purposes of
this analysis, this value of $630 per acre will serve as the
opportunity cost to hemp producers. The opportunity cost is the
potential returns that are foregone in pursuit of an alternative. The
potential foregone returns, in this case, are $630 per acre for corn
cultivation; and, the alternative is hemp cultivation. Applying this
value to the estimates of acreage required to meet estimated producer
sales as calculated in Table 5 results in the total opportunity cost to
producers in years 2020 through 2025 as shown in Table 6.
---------------------------------------------------------------------------
\38\ NASS. Quick Stats. Variable ``Corn, grain--production,
measured in $'' divided by variable ``Corn, grain--acres
harvested''.
Table 6--Calculation of Opportunity Cost of Hemp Cultivation Under Rule
------------------------------------------------------------------------
------------------------------------------------------------------------
2017-2019 average returns per acre of corn for grain \1\ $630
------------------------------------------------------------------------
Year 2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Planted acres due to rule \2\........................... 31,820 56,187 84,437 116,633 137,742 210,465
Opportunity cost (millions) \3\......................... $20 $35 $53 $73 $87 $133
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources and notes:
\1\ National Agriculural Statistics Service (NASS).
\2\ See Table 5 estimate calculation.
\3\ Product of 2017-2019 average retunns per acre of corn for grain and acres worth of hemp sold.
In the IFR, AMS calculated an opportunity cost of $591 per acre,
using an average of returns per acre for all cropland, weighted by area
planted or bearing. This estimate utilized NASS crop totals for fruits,
vegetables, and traditional field crops. At the time of the writing of
the IFR, AMS had little information as to the prior uses of land
currently being cultivated for hemp. To address this in the final rule,
AMS sought input from state departments of agriculture, most of which
reported that the land on which hemp is currently grown was previously
utilized for cultivation of corn.
AMS has modified its sampling and testing requirements, which are
described in the section in this rule titled ``Sampling for total
THC'', to allow for ``performance-based sampling''. A performance-based
protocol must have the potential to ensure at a confidence level of 95
percent that no more than one percent of the plants in each lot would
exceed the acceptable hemp THC level. Performance-based sampling
achieves defined objectives and focuses on results. It differs
significantly from a prescriptive action in which licensees are
provided detailed direction on how those results are to be obtained. A
performance-based approach would simply set a performance objective
(e.g., reliability of 95 percent) and allow the States and Indian
Tribes considerable freedom in how to achieve that reliability
objective with their sampling methodology.
To estimate the number of lots to be sampled in each year, AMS
employs the Cochran Formula:
[GRAPHIC] [TIFF OMITTED] TR19JA21.034
where n0 is the sample size, Z is the z-value associated
with a confidence interval, p is the estimated proportion of the
population that has the attribute in question, and e is the margin of
error or the desired level of precision.
Inserting the z-value that corresponds to a 95 percent confidence
interval, assuming maximum variability for p at 50 percent, and
applying the margin of error of one percent results in the following
sample size:
[[Page 5673]]
[GRAPHIC] [TIFF OMITTED] TR19JA21.035
The Cochran Formula assumes an unlimited population size; however,
the formula can be modified to return a smaller sample size for a
finite population:
[GRAPHIC] [TIFF OMITTED] TR19JA21.036
where n is the modified sample size, n0 is the Cochran
Formula sample size, and N is the population size.
Table 7 shows the number of sampled lots, n, required for a 95
percent confidence interval and one percent margin of error for each
year's total number of lots, N. The total annual cost of sampling and
testing borne by producers is calculated using a cost per lot of $565,
which was estimated using hourly rates for inspectors and for
laboratory services of $75 and $98, respectively; two hours, apiece,
spent sampling, driving, and testing; 120 miles driven; and, $0.58 per
mile compensation. In its calculation of total number of lots from
total planted acreage, AMS utilized the portions of planted acreage by
intended use, introduced in Table 5, and data from the Farm Service
Agency (FSA) from which average lot sizes for hemp by intended use were
derived.
[[Page 5674]]
[GRAPHIC] [TIFF OMITTED] TR19JA21.037
Some portion of tested lots are likely to return results with THC
concentrations greater than 0.3 percent. To estimate this percentage,
AMS utilized data, specific to this very question, collected by the
National Industrial Hemp Regulators during a November 2019 meeting. The
average portion of tests that would return results of THC
concentrations greater than 0.3 percent, weighted by the number of
tests administered in each state, was 25 percent. In Table 8, AMS
applies this percentage to estimate total noncompliant lots in each
year and the cost to dispose of noncompliant acreage. AMS is aware of
other estimates of THC concentration failure rates. As of November
2020, States and Tribes operating under the 2018 Farm Bill reported
4,192 licensed producers representing 6,166 acres planted. Of these
acres planted, approximately 12 percent were destroyed due to THC
levels exceeding 0.3 percent. This data, however, is limited because
many approved plans have not all been fully
[[Page 5675]]
implemented. USDA expects more data will be available as the 2021
season begins and States and Tribes implement their programs.
[GRAPHIC] [TIFF OMITTED] TR19JA21.038
AMS has issued guidance on approved methods for disposal of
noncompliant hemp material, including plowing under, mulching or
composting, disking, bush mowing or chopping, deep burial, and burning.
AMS requires disposal of noncompliant hemp using one of these methods.
Discussion with state departments of agriculture and producers led AMS
to estimate an average of 15 minutes per acre required to dispose of
noncompliant material. This 15-minute estimate is an average across all
disposal methods. According to the May 2019 Occupational Employment
Statistics Survey of the Bureau of Labor and Statistics, the mean
hourly wage of a compliance officer is $35. Assuming 39 percent of
total compensation accounts for benefits, then total compensation of a
compliance officer is $57 per hour. This is described in the Paperwork
Reduction Act (PRA) section of this
[[Page 5676]]
rule. Applying the total hourly salary of a compliance officer to the
disposal time per acre of hemp results in a per acre cost of $14.25 for
disposal of noncompliant hemp acreage.
The PRA section details the burdens of reporting and recordkeeping
and their associated costs. Table 9 shows the calculations of the
reporting and recordkeeping costs to producers that will be imposed by
this rule. All assumptions in this table have been previously
introduced. The PRA section describes how each estimate of time was
calculated per required form.
[GRAPHIC] [TIFF OMITTED] TR19JA21.039
In order to obtain a producer license, AMS requires that each
producer, or key participant of a business entity, submit to a
background check, or criminal history report, at least every three
years. A key participant is a person with a direct or indirect
financial interest in the hemp-producing entity, including a chief
executive officer, a chief operating officer, and a chief financial
officer. The cost of a criminal history report conducted by the Federal
Bureau of Investigation (FBI) is $18 per record. For the purposes of
this analysis, AMS assumes each producer license to represent three key
participants. The total annual cost of a background check for three key
participants every three years at minimum is $18 per producer.
The producer net benefits of this rule to society are shown in
Table 10. Subtracted from producer sales due to the rule are the
opportunity costs of the land on which hemp is currently grown;
sampling and testing costs; disposal of noncompliant acreage; reporting
and recordkeeping burdens; and, annual background checks. The producer
net benefits of this rule to society range from $49 million in 2020 to
$357 million in 2025.
Table 10--Producer Net Benefits to Society
[Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grower sales due to rule................................ $75.51 $133.34 $200.38 $276.78 $326.88 $499.46
Opportunity cost........................................ (20.05) (35.40) (53.20) (73.48) (86.78) (132.59)
Sampling & testing...................................... (3.20) (3.89) (4.30) (4.56) (4.67) (4.91)
Disposal of noncompliant material....................... (0.30) (0.36) (0.40) (0.42) (0.43) (0.46)
Reporting & recordkeeping............................... (2.56) (2.82) (3.10) (3.41) (3.75) (4.12)
Background checks....................................... (0.36) (0.40) (0.44) (0.48) (0.53) (0.58)
-----------------------------------------------------------------------------------------------
Net benefits........................................ 49.05 90.47 138.95 194.43 230.72 356.80
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 5677]]
States, Indian Tribes, and USDA
States and Indian Tribes have the authority to establish fee
structures to fund their hemp programs. As of the writing of this
analysis, about half of the states with plans approved by USDA reported
their programs as being full funded through user-fees. To estimate the
cost of administering a hemp program, AMS calculated an average of the
total fees charged to producers by these states, which reported as
fully user-fee funded, to use as a proxy for the per producer cost of
hemp program administration. The fees used to calculate this average
included those with such designations as application fee, site
registration fee, licensing fee, and others. The average did not
include fees associated with sampling and testing as these were
calculated separately in Table 7. AMS estimates an average cost per
producer of hemp program administration of $800 annually. AMS has no
reason to believe that Indian Tribes or USDA will be any more or any
less efficient than states in program administration. AMS believes,
therefore, that this figure is a suitable proxy for the cost of program
administration to states, Indian Tribes, and USDA per producer who
cultivates hemp as a result of this rule.
As discussed in the ``Baseline Definition'' section, 17 states
opted to participate in the new hemp programs authorized by the 2018
Farm Bill in time for the 2020 growing season. These states represented
20 percent of both planted acreage nationwide and the number of
producers nationwide. By applying this percentage to the total number
of producers in each year, as shown in Table 2, AMS estimates the
number of producers that will cultivate hemp due to this rule. The
product of the number of producers due to this rule and the $800 per
grower proxy for administration costs results in program administration
costs to States, Indian Tribes, and USDA of $3 million in 2020 to $5
million in 2025.
This rule places a reporting and recordkeeping burden on states and
Indian Tribes as detailed in the PRA section of this rule. The total
time required per state or tribe for reporting and recordkeeping is
25.25 hours annually. AMS assumes constant the number of states and
Indian Tribes that will operate their own hemp programs at 100 in total
from 2020 through 2025. In total, the time required of 100 states and
Indian Tribes for 25.25 hours of reporting and recordkeeping is 2,525
hours. Applying the hourly salary of a compliance officer of $57 to
this total results in an annual cost to all states and Indian Tribes of
reporting and recordkeeping of $143,919, or $1,439 per state or tribe.
The total administration costs to states, Indian Tribes, and USDA
are calculated in Table 11. They include the costs to all three
entities of program administration, and the costs of reporting and
recordkeeping to states and Indian Tribes. Total administration costs
to states, Indian Tribes, and USDA range from $3 million in 2020 to $5
million in 2025.
Table 11--Total Costs to States, Indian Tribes, and USDA
[Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Program administration.................................. $(3.20) $(3.52) $(3.87) $(4.26) $(4.69) $(5.15)
Reporting & recordkeeping............................... (0.14) (0.14) (0.14) (0.14) (0.14) (0.14)
-----------------------------------------------------------------------------------------------
Total costs......................................... (3.34) (3.66) (4.02) (4.40) (4.83) (5.30)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Laboratories
This rule also places a reporting and recordkeeping burden on
laboratories as they will be required to report on the results of
samples tested for THC content to the entities administering the hemp
programs. The PRA section of this rule estimates an annual reporting
and recordkeeping requirement for laboratories of 0.58 hours per
sampled and tested lot. As calculated in Table 7, the total number of
lots to be sampled and tested in each year is 5,659 in 2020; 6,886 in
2021; 7,606 in 2022; 8,069 in 2023; 8,272 in 2024; and, 8,688 in 2025.
Multiplying the total number of lots to be sampled and tested in each
year by the annual reporting and recordkeeping requirement of 0.58
hours per sampled and tested lot and by the hourly salary of a
compliance officer of $57 results in the total annual costs to
laboratories as shown in Table 12.
Table 12--Total Costs to Laboratories
[Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting & recordkeeping......................... $(0.19) $(0.23) $(0.25) $(0.27) $0.27) $(0.29)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Net Benefit
Producers, states, Indian Tribes, and USDA, and laboratories are
the entities most likely to be impacted by this rule. For this reason,
the net benefits or costs of this rule to these entities have been
evaluated in this analysis. The total net benefits to society as a
whole and their present values by year are shown in Table 13. The rule
has a positive net benefit in every year, ranging from $46 million in
2020 to $351 million in 2025.
Table 13--Total Net Benefits to Society
[Millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Entity 2020 2021 2022 2023 2024 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
Producers............................................... $49.05 $90.47 $138.95 $194.43 $230.72 $356.80
States, Tribes & USDA................................... (3.34) (3.66) (4.02) (4.40) (4.83) (5.30)
[[Page 5678]]
Laboratories............................................ (0.19) (0.23) (0.25) (0.27) (0.27) (0.29)
-----------------------------------------------------------------------------------------------
Total............................................... 45.52 86.58 134.68 189.76 225.61 351.21
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present values of net benefits annualized at the given discount rates
--------------------------------------------------------------------------------------------------------------------------------------------------------
Discount rates 2020 2021 2022 2023 2024 2024
--------------------------------------------------------------------------------------------------------------------------------------------------------
3%...................................................... $45.52 $84.06 $126.95 $173.66 $200.45 $302.96
7%...................................................... 45.52 80.92 117.63 154.90 172.12 250.41
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternatives
In developing this final rule, AMS considered several alternatives
to the policies that were adopted. The first of these was related to
methodologies for sampling. The methodologies considered include
sampling and testing of all lots, as mandated in the IFR, sampling and
testing based on risk, and sampling and testing based on performance.
The latter of these was the sampling methodology that was chosen for
the final rule as it results in the lowest total cost to producers.
Performance-based sampling also grants flexibility to States and Indian
Tribes in the development of sampling methodologies. In the IFR, AMS
required sampling of every hemp lot, regardless of intended use;
however, AMS has determined that compliance to this method would too
greatly burden producers as well as program administrators, whose
responsibility it would be to enforce it. AMS also considered requiring
risk-based sampling, which would mandate minimum portions of sampling
of lots by intended use. The portions of lots to be sampled by intended
use that were considered were 50 percent of lots for cannabinoids, 10
percent of lots for fiber, and 10 percent of lots for grain. AMS
currently lacks sufficient data to successfully carry out a risk-based
sampling methodology that would be applicable to the varying growing
regions nationwide; therefore, the risk-based sampling methodology was
not chosen for this final rule. An analysis of these sampling
methodologies is illustrated in Table 14.
[GRAPHIC] [TIFF OMITTED] TR19JA21.040
[[Page 5679]]
Secondly, AMS considered retaining at 0.5 percent the limit for
total THC content that would result in a negligent violation, as
required in the IFR. Based on comments, however, AMS has determined
this requirement to too greatly burden producers as factors beyond the
control of the producer, such as seed genetics, weather and climate,
may cause an increase in total THC-levels. By increasing the negligent
violation threshold to 1.0 percent, AMS diminishes the risk to
producers of incurring a negligent violation, which results in time and
cost savings to producers and to program-administering entities.
Finally, AMS considered mandating a post-sample harvest window of
15 days, as required in the IFR. Based on comments and in consideration
of the time required to complete sampling and testing activities, AMS
has determined that requiring a 15-day post-sample harvest window would
place undue strain on resources. AMS believes that the extension of the
post-sample harvest window to 30 days will provide producers with a
beneficial flexibility to adjust to unforeseen weather events and will
accommodate complicated harvest processes.
Regulatory Flexibility Analysis
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (5 U.S.C. 601-612), AMS has considered the economic
impact of this action on small entities. AMS prepared an initial
regulatory flexibility act analysis presented with the interim final
rule, and has now prepared this Final Regulatory Flexibility Act
Analysis. AMS has determined that this rule will have a significant
economic impact on a substantial number of small businesses because
many small businesses will not be able to participate in the hemp
market without this rule.
Need for Regulation
The rule is necessary to facilitate the domestic cultivation of
hemp for sale into the market for hemp products by creating a set of
minimum standards to ensure that hemp being produced under this program
meets all statutory requirements. The rule establishes minimum
requirements for States and Indian Tribes to obtain program approval
and, for producers operating under the Federal program to obtain a
license and meet operating requirements under that license. Without
these provisions, it would not be possible to grow hemp legally.
Both the declassification of hemp, and the prohibition on
interference with interstate transportation apply to hemp that is grown
under an approved State or Tribal plan, or under a Federal license. As
a result, this regulation facilitates provisions of the 2018 Farm Bill
that would otherwise be self-implementing.
Overview of the Action
The 2018 Farm Bill granted regulatory authority of domestic hemp
production to the State departments of agriculture, Tribal governments,
and USDA. States and Indian Tribes wishing to operate their own
programs must submit to USDA plans that include provisions for
maintaining information regarding the land on which hemp is produced,
for testing the levels of THC, for disposal of plants that do not meet
necessary requirements, and for procedures to ensure compliance with
the requirements of the new part, including background checks of all
key participants. State and Tribal Plans must be approved by USDA. This
rule outlines requirements by which the USDA would approve plans
submitted by States and Tribal governments for oversight of hemp
production. The 2018 Farm Bill also directs USDA to develop a plan for
use by hemp producers in States or Indian Tribes where no State or
Tribal Plan has been approved and that do not prohibit the cultivation
of hemp. These actions will promote consistency in regulations
governing the legal production of hemp across the country.
Potentially Affected Small Entities
The Small Business Administration (SBA) defines, in 13 CFR part
121, small agricultural producers as those having annual receipts of no
more than $1 million. Unfortunately, very little data exists on hemp
grower sales receipts. To conduct this analysis, however, AMS estimated
prices per acre by intended use of hemp to find the acreage equivalent
of $1 million per intended use. AMS encountered data limitations due to
the lack of reporting by States and Tribes that have not started
implementing the 2018 Farm Bill provisions and the extension of the
2014 Farm Bill provisions which do not require reporting from States.
To this end, AMS utilized data on acreage by intended use from the
Kentucky Department of Agriculture and the Montana Department of
Agriculture. Together, Kentucky and Montana make up a large amount of
domestic acreage and represent diversity in hemp planted by intended
use. For the purpose of this analysis, therefore, AMS assumes that the
combined planted acreage by intended use in Kentucky and Montana
adequately represent the planted acreage by intended use across the
United States.
For yield estimates, AMS compared the hemp enterprise budgets
published by seven different academic institutions that represent the
growing conditions across the country. Aside from these seven, AMS is
unaware of any other hemp enterprise budgets published by an academic
institution. AMS sourced 2019 and 2020 prices from the Jacobsen to
estimate per-pound prices for cannabinoids, fiber, and grain of $3.90,
$0.09, and $0.53, respectively. The price for cannabinoids assumes 6
percent CBD content at $0.65 per CBD percentage per pound.
Using these prices and yield estimates, AMS calculated a price per
acre for each intended use of hemp, as shown in Table 15. From the
estimates of price per acre by intended use, AMS calculated the
equivalent of $1 million in acres of hemp product per intended use. Of
the 922 unique producers in the combined data from the Kentucky and
Montana Departments of Agriculture, 97 percent reported acreage no
greater than the amounts necessary to reach $1 million, based on the
estimated prices per acre. Assuming that these data are representative
of the U.S. as a whole, then 97 percent of domestic producers of hemp
would meet the SBA size standard of a small business of annual receipts
of no greater than $1 million.
[[Page 5680]]
[GRAPHIC] [TIFF OMITTED] TR19JA21.041
Alternatives Considered To Minimize Impacts of the Rule
In developing this final rule, due to comments received and
experiences from the 2020 season, AMS considered several alternatives
to the policies that were adopted. The first of these was related to
methodologies for sampling. The methodologies considered include
sampling and testing of all lots, as mandated in the IFR, sampling and
testing based on risk, and sampling and testing based on performance.
The latter of these was the sampling methodology that was chosen for
the final rule as it results in the lowest total cost to producers.
Performance-based sampling also grants flexibility to States and Indian
Tribes in the development of sampling methodologies. Some States
currently have considered performance-based sampling under the 2014
Farm Bill. However, this information is not available and will need to
be evaluated and approved by USDA as part of State and Tribal plans
before it can be implemented under the 2018 Farm Bill program if States
and Tribes decide to utilize this option. In the IFR, AMS required
sampling of every hemp lot, regardless of intended use; however, AMS
has determined that compliance to this method would too greatly burden
producers as well as program administrators, whose responsibility it
would be to enforce it. AMS also considered requiring risk-based
sampling, which would mandate minimum portions of sampling of lots by
intended use. The portions of lots to be sampled by intended use that
were considered were 50 percent of lots for cannabinoids, 10 percent of
lots for fiber, and 10 percent of lots for grain. AMS currently lacks
sufficient data to successfully carry out a risk-based sampling
methodology that would be applicable to the varying growing regions
nationwide; therefore, the risk-based sampling methodology was not
chosen for this final rule.
Secondly, AMS considered retaining at 0.5 percent the limit for
total THC content that would result in a negligent violation, as
required in the IFR. Based on comments, however, AMS has determined
this requirement to too greatly burden producers as factors beyond the
control of the producer, such as seed genetics, weather and climate,
may cause an increase in total THC-levels. By increasing the negligent
violation threshold to 1.0 percent, AMS diminishes the risk to
producers of incurring a negligent violation, which results in time and
cost savings to producers and to program-administering entities.
Finally, AMS considered mandating a post-sample harvest window of
15 days, as required in the IFR. Based on comments and in consideration
of the time required to complete sampling and testing activities, AMS
has determined that requiring a 15-day post-sample harvest window would
place undue strain on resources. AMS believes that the extension of the
post-sample harvest window to 30 days will provide producers with a
beneficial flexibility to adjust to unforeseen weather events and will
accommodate complicated harvest processes.
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as ``major,'' as defined by 5 U.S.C. 804(2).
List of Subjects in 7 CFR Part 990
Acceptable hemp THC level, Agricultural commodities, Cannabis,
Corrective action plan, Delta-9 tetrahydrocannabinol, Drugs, Dry weight
basis, Hemp, Liquid chromatography, Laboratories, Marijuana.
0
For the reasons stated in the preamble, AMS revises 7 CFR part 990 to
read as follows:
[[Page 5681]]
PART 990--DOMESTIC HEMP PRODUCTION PROGRAM
Subpart A--Definitions
Sec.
990.1 Meaning of terms.
Subpart B--State and Tribal Hemp Production Plans
990.2 State and Tribal plans; General authority.
990.3 State and Tribal plans; Plan requirements.
990.4 USDA approval of State and Tribal plans.
990.5 Audit of State or Tribal plan compliance.
990.6 Violations of State and Tribal plans.
990.7 Establishing records with USDA Farm Service Agency.
990.8 Production under Federal law.
Subpart C--USDA Hemp Production Plan
990.20 USDA requirements for the production of hemp.
990.21 USDA hemp producer license.
990.22 USDA hemp producer license approval.
990.23 Reporting hemp crop acreage with USDA Farm Service Agency.
990.24 Responsibility of a USDA licensee prior to harvest.
990.25 Standards of performance for detecting total delta-9
tetrahydrocannabinol (THC) concentration levels.
990.26 Responsibility of a USDA producer after laboratory testing is
performed.
990.27 Non-compliant cannabis plants.
990.28 Compliance.
990.29 Violations.
990.30 USDA producers; License suspension.
990.31 USDA licensees; Revocation.
990.32 Recordkeeping requirements.
Subpart D--Appeals
990.40 General adverse action appeal process.
990.41 Appeals under the USDA hemp production plan.
990.42 Appeals under a State or Tribal hemp production plan.
Subpart E--Administrative Provisions
990.60 Agents.
990.61 Severability.
990.62 [Reserved]
990.63 Interstate transportation of hemp.
Subpart F--Reporting Requirements
990.70 State and Tribal hemp reporting requirements.
990.71 USDA plan reporting requirements.
Authority: 7 U.S.C. 1639o note, 1639p, 1639q, 1639r.
Subpart A--Definitions
Sec. 990.1 Meaning of terms.
Words used in this subpart in the singular form shall be deemed to
impart the plural, and vice versa, as the case may demand. For the
purposes of provisions and regulations of this part, unless the context
otherwise requires, the following terms shall be construed,
respectively, to mean:
Acceptable hemp THC level. When a laboratory tests a sample, it
must report the total delta-9 tetrahydrocannabinol content
concentration level on a dry weight basis and the measurement of
uncertainty. The acceptable hemp THC level for the purpose of
compliance with the requirements of State or Tribal hemp plans or the
USDA hemp plan is when the application of the measurement of
uncertainty to the reported total delta-9 tetrahydrocannabinol content
concentration level on a dry weight basis produces a distribution or
range that includes 0.3 percent or less. For example, if the reported
total delta-9 tetrahydrocannabinol content concentration level on a dry
weight basis is 0.35 percent and the measurement of uncertainty is
0.06 percent, the measured total delta-9
tetrahydrocannabinol content concentration level on a dry weight basis
for this sample ranges from 0.29 percent to 0.41 percent. Because 0.3
percent is within the distribution or range, the sample is within the
acceptable hemp THC level for the purpose of plan compliance. This
definition of ``acceptable hemp THC level'' affects neither the
statutory definition of hemp, 7 U.S.C. 1639o(1), in the 2018 Farm Bill
nor the definition of ``marihuana,'' 21 U.S.C. 802(16), in the CSA.
Act. Agricultural Marketing Act of 1946.
Agricultural Marketing Service or AMS. The Agricultural Marketing
Service of the U.S. Department of Agriculture.
Applicant. (1) A State or Indian Tribe that has submitted a State
or Tribal hemp production plan to USDA for approval under this part; or
(2) A producer in a State or territory of an Indian Tribe that is
not subject to a State or Tribal hemp production plan and who has
submitted an application to USDA for a license under the USDA hemp
production plan under this part.
Audit. An official inspection of an individual's or organization's
accounts and paperwork or documentation by an independent body. An
audit also refers to a compliance audit of States and Indian Tribes
with approved hemp production plans by USDA to determine compliance
with their approved plan, the regulations in this part, and the Act.
For this part, audit relates to documentation related to authorities
under the 2018 Farm Bill to produce hemp.
Cannabis. 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. Cannabis refers to any form of the
plant in which the total delta-9 tetrahydrocannabinol concentration on
a dry weight basis has not yet been determined.
Controlled Substances Act (CSA). The Controlled Substances Act as
codified in 21 U.S.C. 801 et seq.
Conviction. Means any plea of guilty or nolo contendere, or any
finding of guilt, except when the finding of guilt is subsequently
overturned on appeal, pardoned, or expunged. For purposes of this part,
a conviction is expunged when the conviction is removed from the
individual's criminal history record and there are no legal
disabilities or restrictions associated with the expunged conviction,
other than the fact that the conviction may be used for sentencing
purposes for subsequent convictions. In addition, where an individual
is allowed to withdraw an original plea of guilty or nolo contendere
and enter a plea of not guilty and the case is subsequently dismissed,
the individual is no longer considered to have a conviction for
purposes of this part.
Corrective action plan. A plan proposed by a licensed hemp producer
and approved by the governing entity for correcting a negligent
violation or non-compliance with the applicable State, Tribal, or USDA
hemp production plan, its terms, the applicable law(s), and/or this
part. Also, a plan proposed by a State or Tribal government for
correcting violations or non-compliances with USDA-approved State or
Tribal hemp programs.
Criminal history report. The Federal Bureau of Investigation's
Identity History Summary.
Culpable mental state greater than negligence. To act
intentionally, knowingly, willfully, or recklessly.
Decarboxylated. 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
molecular mass conversion ratio that sums delta-9 THC and eighty-seven
and seven tenths (87.7) percent of THC-acid ((delta-9 THC) + (0.877 *
THCA)).
Decarboxylation. The removal or elimination of carboxyl group from
a molecule or organic compound.
Disposal. An activity that transitions the non-compliant product
into a non-retrievable or non-ingestible form. Such activities include
plowing, tilling, or disking plant material into the soil; mulching,
composting, chopping, or bush mowing plant material into green
[[Page 5682]]
manure; burning plant material; burying plant material into the earth
and covering with soil.
Delta-9 tetrahydrocannabinol or THC. Delta-9 THC is the primary
psychoactive component of cannabis. For the purposes of this part,
delta-9 THC and THC are interchangeable.
Drug Enforcement Administration or DEA. The United States Drug
Enforcement Administration.
Dry weight basis. The ratio of the amount of moisture in a sample
to the amount of dry solid in a sample. A basis for expressing 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.
Entity. A corporation, joint stock company, association, limited
partnership, limited liability partnership, limited liability company,
irrevocable trust, estate, charitable organization, or other similar
organization, including any such organization participating in the hemp
production as a partner in a general partnership, a participant in a
joint venture, or a participant in a similar organization.
Farm Service Agency or FSA. An agency of the United States
Department of Agriculture.
Gas chromatography or GC. A type of chromatography in analytical
chemistry used to separate, identify, and quantify each component in a
mixture. GC relies on heat for separating and analyzing compounds that
can be vaporized without decomposition.
Geospatial location. A location designated through a global system
of navigational satellites used to determine the precise ground
position of a place or object.
Handle. To harvest or store hemp plants or hemp plant parts prior
to the delivery of such plants or plant parts for further processing.
``Handle'' also includes the disposal of cannabis plants that are not
hemp for purposes of chemical analysis and disposal of such plants.
Hemp. 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 total delta-9 tetrahydrocannabinol concentration
of not more than 0.3 percent on a dry weight basis.
Immature plants. A cannabis plant that is not flowering.
Indian Tribe or Tribe. As defined in section 4 of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 5304).
Information sharing system. The database that allows USDA to share
information collected under State, Tribal, and USDA plans with Federal,
State, Tribal, and local law enforcement.
Key participants. A sole proprietor, a partner in partnership, or a
person with executive managerial control in a corporation. A person
with executive managerial control includes persons such as a chief
executive officer, chief operating officer, and chief financial
officer. This definition does not include non-executive managers such
as farm, field, or shift managers. This definition also does not
include a member of the leadership of a Tribal government who is acting
in their capacity as a Tribal leader except when that member exercises
executive managerial control over hemp production.
Law enforcement agency. Any Federal, State, Tribal, or local law
enforcement agency.
Liquid chromatography or LC. A type of chromatography technique in
analytical chemistry used to separate, identify, and quantify each
component in a mixture. LC relies on pumps to pass a pressurized liquid
solvent containing the sample mixture through a column filled with a
solid absorbent material to separate and analyze compounds.
Lot. A contiguous area in a field, greenhouse, or indoor growing
structure containing the same variety or strain of cannabis throughout
the area. The term lot also means the terms ``farm,'' ``tract,''
``field,'' and ``subfield'' as these are terms used by FSA in 7 CFR
718.2 to define lot.
Marijuana. Or ``marihuana'', as defined in the CSA, 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). ``Marihuana'' means
all cannabis that tests as having a THC concentration level of higher
than 0.3 percent on a dry weight basis.
Measurement of Uncertainty (MU). The parameter, associated with the
result of a measurement, that characterizes the dispersion of the
values that could reasonably be attributed to the particular quantity
subject to measurement.
Negligence. Failure to exercise the level of care that a reasonably
prudent person would exercise in complying with the regulations set
forth under this part.
Phytocannabinoid. Cannabinoid chemical compounds found in the
cannabis plant, two of which are delta-9 tetrahydrocannabinol (delta-9
THC) and cannabidiol (CBD).
Plan. A set of criteria or regulations under which a State or
Tribal government, or USDA, monitors and regulates the production of
hemp.
Post-decarboxylation. In the context of testing methodologies for
THC concentration levels in hemp, means a value determined after the
process of decarboxylation that determines the potential total delta-9
tetrahydrocannabinol content derived from the sum of the THC and THCA
content and reported on a dry weight basis. The post-decarboxylation
value of THC can be calculated by using a chromatograph technique using
heat, gas chromatography, through which THCA is converted from its acid
form to its neutral form, THC. Thus, this test calculates the total
potential THC in a given sample. The post-decarboxylation value of THC
can also be calculated by using a liquid chromatograph technique, which
keeps the THCA intact. This technique requires the use of the following
conversion: [Total THC = (0.877 x THCA) + THC] which calculates the
potential total THC in a given sample. See the definition for
decarboxylation.
Produce. To grow hemp plants for market, or for cultivation for
market, in the United States.
Producer. A producer as defined in 7 CFR 718.2 specifically of
hemp.
Remediation. Remediation refers to the process of rendering non-
compliant cannabis, compliant. Remediation can occur by removing and
destroying flower material, while retaining stalk, stems, leaf
material, and seeds. Remediation can also occur by shredding the entire
plant into a biomass like material, then re-testing the shredded
biomass material for compliance.
Reverse distributor. A person who is registered with the DEA in
accordance with 21 CFR 1317.15 to dispose of
[[Page 5683]]
marijuana under the Controlled Substances Act.
Secretary. The Secretary of Agriculture of the United States
Department of Agriculture.
State. Any 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.
State department of agriculture. The agency, commission, or
department of a State government responsible for agriculture in the
State.
Territory of the Indian Tribe. (1) All land within the limits of
any Indian reservation under the jurisdiction of the United States
Government, notwithstanding the issuance of any patent, including
rights-of-way running through the reservation;
(2) All dependent Indian communities within the borders of the
United States whether within the original or subsequently acquired
territory thereof, and whether within or without the limits of a State;
(3) All Indian allotments, the Indian titles to which have not been
extinguished, including rights-of-way running through the same; and
(4) Any lands title to which is either held in trust by the United
States for the benefit of any Indian Tribe or individual or held by any
Indian Tribe or individual subject to restriction by the United States
against alienation and over which an Indian Tribe exercises
jurisdiction.
Total THC. Total THC is the value determined after the process of
decarboxylation, or the application of a conversion factor if the
testing methodology does not include decarboxylation, that expresses
the potential total delta-9 tetrahydrocannabinol content derived from
the sum of the THC and THCA content and reported on a dry weight basis.
This post-decarboxylation value of THC can be calculated by using a
chromatograph technique using heat, such as gas chromatography, through
which THCA is converted from its acid form to its neutral form, THC.
Thus, this test calculates the total potential THC in a given sample.
The total THC can also be calculated by using a liquid chromatograph
technique, which keeps the THCA intact. This technique requires the use
of the following conversion: [Total THC = (0.877 x THCA) + THC] which
calculates the potential total THC in a given sample.
Tribal government. The governing body of an Indian Tribe.
USDA licensee. A person, partnership, or corporation licensed under
the USDA planto grow hemp under the terms established in this part and
who produces hemp.
Subpart B--State and Tribal Hemp Production Plans
Sec. 990.2 State and Tribal plans; General authority.
States or Indian Tribes desiring to have primary regulatory
authority over the production of hemp in the State or territory of the
Indian Tribe shall submit to the Secretary for approval, through the
State department of agriculture (in consultation with the Governor and
chief law enforcement officer of the State) or the Tribal government,
as applicable, a plan under which the State or Indian Tribe monitors
and regulates that production.
Sec. 990.3 State and Tribal plans; Plan requirements.
(a) General requirements. A State or Tribal plan submitted to the
Secretary for approval must include the practice and procedures
described in this paragraph (a).
(1) A State or Tribal plan must include a practice to collect,
maintain, and report to the Secretary relevant, real-time information
for each producer licensed or authorized to produce hemp under the
State or Tribal plan regarding:
(i) Contact information as described in Sec. 990.70(a)(1);
(ii) A legal description of the land on which the producer will
produce hemp in the State or territory of the Indian Tribe including,
to the extent practicable, its geospatial location; and
(iii) The status and number of the producer's license or
authorization in a format prescribed by USDA.
(2) A State or Tribal plan must include a procedure for accurate
and effective sampling of hemp that includes the requirements in this
paragraph (a)(2).
(i) Samples from cannabis plants must be collected within 30 days
prior to the anticipated harvest, for total delta-9
tetrahydrocannabinol concentration level testing. Samples must be
collected by a sampling agent. Producers may not collect samples from
their own growing facilities.
(ii) Samples shall be obtained from the flowering tops of plants
when flowering tops are present, and shall be approximately five to
eight inches in length from the ``main stem'' (that includes the leaves
and flowers), ``terminal bud'' (that occurs at the end of a stem), or
``central cola'' (cut stem that could develop into a bud) of the
flowering top of the plant.
(iii) The method used for sampling must be sufficient at a
confidence level of 95 percent that no more than one percent of the
plants in each lot would exceed the acceptable hemp THC level and
ensure that a representative sample is collected that represents a
homogeneous composition of the lot. Alternatively, States and Tribes
may adopt a performance-based method that meets the requirements in
paragraphs (a)(2)(iii)(A) and (B) of this section.
(A) The alternative method must be part of the State or Tribe's
hemp plan and is subject to USDA approval.
(B) The alternative method must have the potential to ensure, at a
confidence level of 95 percent, that the cannabisplant species Cannabis
sativa L. that will be subject to the alternative method will not test
above the acceptable hemp THC level. The alternative method may
consider one or more of the following factors:
(1) Seed certification process or process that identifies varieties
that have consistently demonstrated to result in compliant hemp plants
in that State or territory of the Indian Tribe;
(2) Whether the producer is conducting research on hemp;
(3) Whether a producer has consistently produced compliant hemp
plants over an extended period of time; and
(4) Factors similar to those in this paragraph (a)(2)(iii)(B).
(iv) During a scheduled sample collection, the producer or an
authorized representative of the producer shall be present at the
growing site if possible.
(v) Sampling agents shall be provided with complete and
unrestricted access during business hours to all hemp and other
cannabis plants (whether growing or harvested), to areas where hemp is
grown and stored, and to all land, buildings, and other structures used
for the cultivation, handling, and storage of all hemp and other
cannabis plants, and all locations listed in the producer license.
(vi) A producer shall not harvest the cannabis crop prior to
samples being taken.
(vii) Sampling agents must be trained using USDA, State, or Tribal
training procedures. States and Indian Tribes must maintain
information, available to producers, about trained sampling agents.
(3) A State or Tribal plan must include a procedure for testing
that is able to accurately identify whether the sample contains a total
delta-9 tetrahydrocannabinol content concentration level that exceeds
the acceptable hemp THC level. The procedure must include a validated
testing methodology that uses post-
[[Page 5684]]
decarboxylation or other similarly reliable methods. The testing
methodology must consider the potential conversion of THCA in hemp into
THC and the test result must report the total available THC derived
from the sum of the THC and THCA content. Testing methodologies meeting
the requirements of this paragraph (a)(3) include, but are not limited
to, gas or liquid chromatography with detection. The total THC
concentration level shall be determined and reported on a dry weight
basis.
(i) Any test of a representative sample resulting in higher than
the acceptable hemp THC level shall be conclusive evidence that the lot
represented by the sample is not in compliance with this part and shall
be disposed of or remediated in accordance with Sec. 990.27.
(ii) Samples of hemp plant material from one lot shall not be
commingled with hemp plant material from other lots.
(iii) Laboratories conducting analytical testing for purposes of
detecting the concentration levels of Total THC shall meet the
following requirements:
(A) Laboratory quality assurance must ensure the validity and
reliability of test results;
(B) Analytical method selection, validation, and verification must
ensure that the testing method used is appropriate (fit for purpose),
and that the laboratory can successfully perform the testing;
(C) The demonstration of testing validity must ensure consistent,
accurate analytical performance;
(D) Method performance specifications must ensure analytical tests
are sufficiently sensitive for the purposes of the detectability
requirements of this part; and
(E) Effective disposal procedures for non-compliant samples that do
not meet the requirements of this part.
(F) Measurement of uncertainty (MU) must be estimated and reported
with test results. Laboratories shall use appropriate, validated
methods and procedures for all testing activities and evaluate
measurement of uncertainty.
(G) Sample preparation of pre- or post-harvest samples shall
require grinding of sample to ensure homogeneity of plant material
prior to testing. Sample preparation may follow a procedure described
by USDA.
(H) After December 31, 2022, States and Indian Tribes shall require
that only laboratories registered with the DEA may conduct testing
under this section.
(4) A State or Indian Tribe shall require testing laboratories to
comply with USDA reporting requirements in subpart F of this part.
Laboratories shall only submit test results used to determine
compliance with this part. Test results from informal testing conducted
throughout the growing season shall not be reported to USDA.
(5) A State or Tribal plan must include a procedure to comply with
the enforcement procedures in Sec. 990.6.
(6) A State or Tribal plan must include a procedure for the
disposal or remediation of cannabis plants if the sample representing
that plant tests above the acceptable hemp THC level.
(i) The disposal must be conducted either by using a DEA-registered
reverse distributor or law enforcement; or on site at the farm or hemp
production facility.
(ii) The State or Tribal plan must include procedures to verify the
disposal or remediation of the cannabis plant. This may come in the
form of in-person verification by State or Tribal representatives, or
alternative requirements that direct growers to provide pictures,
videos, or other proof that disposal or remediation occurred
successfully. Disposal and remediation means are described at AMS's
website.
(iii) If a producer elects to perform remediation activities, an
additional sampling and testing of the post-remediated crop must occur
to determine THC concentration levels.
(7) A State or Tribal plan must include a procedure for conducting
annual inspections of, at a minimum, a random group of producers to
verify that hemp is not produced in violation of this part.
(8) A State or Tribal plan must include a procedure for submitting
the report described in Sec. 990.70 to the Secretary by the first of
each month. If the first of the month falls on a weekend or holiday,
the report is due by the first business day following the due date. All
such information must be submitted to the USDA in a format that is
compatible with USDA's information sharing system.
(9) The State or Tribal government must certify that the State or
Indian Tribe has the resources and personnel to carry out the practices
and procedures described in paragraphs (a)(1) through (9) of this
section.
(10) The State or Tribal plan must include a procedure to collect
and share information with USDA to support the information sharing
requirements in 7 U.S.C. 1639q(d). The State or Tribal government is
responsible for reporting the information identified in paragraphs
(a)(10)(i) through (iii) of this section with AMS. The State or Tribal
hemp production plan must include the following:
(i) A requirement that producers report their hemp crop acreage to
the FSA, consistent with the requirement in Sec. 990.7.
(ii) Assignment of a license or authorization identifier for each
producer in a format prescribed by USDA.
(iii) A requirement that producers report the total acreage of hemp
planted, harvested, and, if applicable, disposed or remediated. The
State or Tribal government shall collect this information and report it
to AMS.
(b) Relation to State and Tribal law. A State or Tribal plan may
include any other practice or procedure established by a State or
Indian Tribe, as applicable; Provided, That the practice or procedure
is consistent with this part and Subtitle G of the Act.
(1) No preemption. Nothing in this part preempts or limits any law
of a State or Indian Tribe that:
(i) Regulates the production of hemp; and
(ii) Is more stringent than this part or Subtitle G of the Act.
(2) References in plans. A State or Tribal plan may include a
reference to a law of the State or Indian Tribe regulating the
production of hemp, to the extent that the law is consistent with this
part.
Sec. 990.4 USDA approval of State and Tribal plans.
(a) General authority. No later than 60 calendar days after the
receipt of a State or Tribal plan for a State or Tribal territory in
which production of hemp is legal, the Secretary shall:
(1) Approve the State or Tribal plan only if the State or Tribal
plan complies with this part; or
(2) Disapprove the State or Tribal plan if the plan does not comply
with this part. USDA shall provide the State or Tribe with written
notification of the disapproval and the cause for the disapproval.
(b) Amended plans. A State or Tribal government, as applicable,
must submit to the Secretary an amended plan if:
(1) The Secretary disapproves a State or Tribal plan and the State
or Indian Tribe wishes to have primary regulatory authority over hemp
production within its State or territory of the Indian Tribe; or
(2) The State or Indian Tribe makes substantive revisions to its
plan or its laws which alter the way the plan meets the requirements of
this part. If this occurs, the State or Tribal government must re-
submit the revised plan for USDA approval. Such re-submissions should
be provided to USDA within 60 days from the date that the State or
[[Page 5685]]
Tribal laws and regulations are effective. Producers shall continue to
comply with the requirements of the existing plan while such
modifications are under consideration by USDA. If State or Tribal
government laws or regulations in effect under the USDA-approved plan
change but the State or Tribal government does not submit a revised
plan within 60 days from the effective date of the new law or
regulation, the existing plan is revoked.
(3) USDA approval of State or Tribal government plan shall remain
in effect unless an amended plan must be submitted to USDA because of a
substantive revision to a State's or Tribe's plan, a relevant change in
State or Tribal laws or regulations, or approval of the plan is revoked
by USDA.
(4) Upon USDA approval of a Tribal plan, an Indian Tribe may
exercise jurisdiction and therefore primary regulatory authority over
all production of hemp in its Territory regardless of the extent of its
inherent regulatory authority.
(c) Technical assistance. The Secretary may provide technical
assistance to help a State or Indian Tribe develop or amend a plan.
This may include the review of draft plans or other informal
consultation as necessary.
(d) Approved State or Tribal plans. If the Secretary approves a
State or Tribal plan, the Secretary shall notify the State or Indian
Tribe by letter or email.
(1) In addition to the approval letter, the State or Indian Tribe
shall receive their plan approval certificate either as an attachment
or via website link.
(2) The USDA shall post information regarding approved plans on its
website.
(3) USDA approval of State or Tribal government plans shall remain
in effect unless:
(i) The State or Tribal government's laws and regulations in effect
under the USDA-approved plan change, thus requiring such plan to be
revised and re-submitted for USDA approval.
(ii) A State or Tribal plan must be amended in order to comply with
future amendments to Subtitle G the Act and this part.
(e) Producer rights upon revocation of State or Tribal plan. If
USDA revokes approval of a State or Tribal plan due to noncompliance as
defined in paragraph (b)(2) of this section and Sec. 990.5, producers
licensed or authorized to produce hemp under the revoked State or
Tribal plan may continue to produce for the remainder of the calendar
year in which the revocation became effective. Producers operating in a
State or Tribal territory with a revoked plan would have to apply to
USDA for a license to continue producing.
Sec. 990.5 Audit of State or Tribal plan compliance.
The Secretary may conduct an audit to determine a State or Indian
Tribe's compliance with their approved plan.
(a) Frequency of audits. Compliance audits may be scheduled, no
more frequently than every three years, based on available resources.
Audits may include an onsite-visit, a desk-audit, or both. The USDA may
adjust the frequency of audits if deemed appropriate based on program
performance, compliance issues, or other relevant factors identified
and provided to the State or Tribal governments by USDA.
(b) Scope of audit review. The audit may include, but is not
limited to, a review of the following:
(1) The resources and personnel employed to administer and oversee
its approved plan;
(2) The process for licensing and systematic compliance review of
hemp producers;
(3) Sampling methods and laboratory testing requirements and
components;
(4) Disposal and/or remediation of non-compliant hemp plants or
hemp plant material practices, to ensure that correct reporting to the
USDA has occurred;
(5) Results of and methodology used for the annual inspections of
producers; and
(6) Information collection procedures and information accuracy
(i.e., geospatial location, contact information reported to the USDA,
legal description of land).
(c) Audit reports. (1) Audit reports will be issued to the State or
Tribal government no later than 60 days after the audit concludes. If
the audit reveals that the State or Tribal government is not in
compliance with its USDA approved plan, USDA will advise the State or
Indian Tribe of non-compliances and the corrective measures that must
be completed to come into compliance with the Act and regulations in
this part. The USDA will require the State or Indian Tribe to develop a
corrective action plan, which must be reviewed and approved by the
USDA. The corrective action plan must include a reasonable date by
which the State or Indian Tribe will correct make corrections. USDA
will approve or deny the corrective action plan within 60 days of its
receipt. USDA will conduct a second audit to determine if the State or
Indian Tribe is in compliance with the corrective action plan and has
corrected the non-compliances.
(2) If the USDA determines that the State or Indian Tribe is not in
compliance after the second audit, the USDA may revoke its approval of
the State or Tribal plan for one year or until the State or Indian
Tribe becomes compliant whichever occurs later. USDA will not approve a
State or Indian Tribe's plan until the State or Indian Tribe
demonstrates upon inspection that it is in compliance with all
regulations in this part.
Sec. 990.6 Violations of State and Tribal plans.
(a) Producer violations. Producer violations of USDA-approved State
and Tribal hemp production plans shall be subject to enforcement in
accordance with the terms of this section.
(b) Negligent violations. Each USDA-approved State or Tribal plan
shall contain provisions relating to negligent producer violations as
defined under this part. Producers shall not receive more than one
negligent violation per growing season. Negligent violations shall
include:
(1) Failure to provide a legal description of land on which the
producer produces hemp;
(2) Failure to obtain a license or other required authorization
from the State department of agriculture or Tribal government, as
applicable; or
(3) Production of cannabis with a total delta-9
tetrahydrocannabinol concentration exceeding the acceptable hemp THC
level. Hemp producers do not commit a negligent violation under this
paragraph (b)(3) if they make reasonable efforts to grow hemp and the
cannabis (marijuana) does not have a total delta-9 tetrahydrocannabinol
concentration of more than 1.0 percent on a dry weight basis.
(c) Corrective action for negligent violations. Each USDA-approved
State or Tribal plan shall provide for the correction of negligent
violations. Each corrective action plan shall include, at a minimum,
the following terms:
(1) A reasonable date by which the producer shall correct the
negligent violation.
(2) A requirement that the producer periodically report to the
State department of agriculture or Tribal government, as applicable, on
its compliance with the State or Tribal plan and corrective action plan
for a period of not less than the next 2 years from the date of the
negligent violation.
(3) A producer that negligently violates a State or Tribal plan
approved under this part shall not as a result of that violation be
subject to any criminal
[[Page 5686]]
enforcement action by the Federal, State, Tribal, or local government.
(4) A producer that negligently violates a State or Tribal plan
three times during a 5-year period shall be ineligible to produce hemp
for a period of 5 years beginning on the date of the third violation.
(5) The State or Indian Tribe shall conduct an inspection to
determine if the corrective action plan has been implemented as
submitted.
(d) Culpable violations. Each USDA-approved State or Tribal plan
shall contain provisions relating to producer violations made with a
culpable mental state greater than negligence, including that:
(1) If the State or Tribal government determines that a producer
has violated the plan with a culpable mental state greater than
negligence, the State or Tribal government, as applicable, shall
immediately report the producer to:
(i) The U.S. Attorney General; and
(ii) The chief law enforcement officer of the State or Indian
Tribe, as applicable.
(2) Paragraphs (b) and (c) of this section shall not apply to
culpable violations.
(e) Felonies. Each USDA-approved State or Tribal plan shall contain
provisions relating to felonies. Such provisions shall state that:
(1) A person with a State or Federal felony conviction relating to
a controlled substance may not participate in the plan and may not
produce hemp under the State or Tribal plan for 10 years from the date
of the conviction. An exception applies to a person who was lawfully
growing hemp under section 7606 of the Agricultural Act of 2014 (7
U.S.C. 5940) before December 20, 2018, and whose conviction also
occurred before that date.
(2) The State or Tribal plan shall define who is participating in
the plan or program and is subject to the felony conviction restriction
for purposes of paragraph (e)(1) of this section. To determine whether
a person is subject to the felony conviction restriction, the State or
Tribe much obtain a criminal history report for that person. The State
or Indian Tribe may require additional reports or checks as it deems
necessary.
(3) For each license or authorization that the State or Indian
Tribe issues, its plan must identify at least one individual as
participating in the plan and for whom it will obtain a criminal
history report to determine eligibility under paragraph (e)(1) of this
section.
(f) False statement. Each USDA-approved State or Tribal plan shall
state that any person who materially falsifies any information
contained in an application to participate in such program shall be
ineligible to participate in that program.
(g) Appeals. For States and Indian Tribes who wish to appeal an
adverse action, subpart D of this part will apply.
Sec. 990.7 Establishing records with USDA Farm Service Agency.
All producers licensed to produce hemp under an USDA-approved State
or Tribal plan shall report hemp crop acreage to FSA and shall provide,
at minimum, the following information:
(a) Street address and, to the extent practicable, geospatial
location for each lot or greenhouse where hemp will be produced. If an
applicant operates in more than one location, or is producing under
multiple licenses, production information shall be provided for each
location.
(b) Acreage dedicated to the production of hemp, or greenhouse or
indoor square footage dedicated to the production of hemp.
(c) License or authorization identifier in a format prescribed by
USDA.
Sec. 990.8 Production under Federal law.
Nothing in this subpart prohibits the production of hemp in a State
or the territory of an Indian Tribe for which a State or Tribal plan is
not approved under this subpart if produced in accordance with subpart
C of this part, and if the production of hemp is not otherwise
prohibited by the State or Indian Tribe.
Subpart C--USDA Hemp Production Plan
Sec. 990.20 USDA requirements for the production of hemp.
(a) General hemp production requirements. The production of hemp in
a State or territory of an Indian Tribe where there is no USDA approved
State or Tribal plan must be conducted in accordance with this subpart,
provided that the production of hemp is not prohibited by the State or
territory of an Indian Tribe where production will occur.
(b) Convicted felon ban. A person with a State or Federal felony
conviction relating to a controlled substance is subject to a 10-year
ineligibility restriction on participating in and producing hemp under
the USDA plan from the date of the conviction. An exception applies to
a person who was lawfully growing hemp under section 7606 of the
Agricultural Act of 2014 (7 U.S.C. 5940) before December 20, 2018, and
whose conviction also occurred before that date.
(c) Falsifying material information on application. Any person who
materially falsifies any information contained in an application for a
license under the USDA plan shall be ineligible to participate in the
USDA plan.
Sec. 990.21 USDA hemp producer license.
(a) General application requirements--(1) Requirements and license
application. Any person producing or intending to produce hemp must
have a valid license prior to producing hemp. A valid license means the
license is unexpired, unsuspended, and unrevoked.
(2) Application dates. Applicants may submit an application for a
license at any time.
(3) Required information on application. The applicant shall
provide the information requested on the application form, including:
(i) Contact information. Full name, residential address, telephone
number, and email address. If the applicant is a business entity, the
full name of the business, the principal business location address,
full name and title of the key participants, title, email address (if
available), and employer identification number (EIN) of the business;
and
(ii) Criminal history report. A current criminal history report for
an individual, or if the applicant is a business entity, all key
participants, dated within 60 days of the application submission date.
A license application will not be considered complete without all
required criminal history reports.
(4) Submission of completed application forms. Completed
application forms shall be submitted to USDA.
(5) Incomplete application procedures. Applications missing
required information shall be returned to the applicant as incomplete.
The applicant may resubmit a completed application.
(6) License expiration. USDA-issued hemp producer licenses shall be
valid until December 31 of the year three years after the year in which
license was issued.
(b) License renewals. USDA hemp producer licenses must be renewed
prior to license expiration. Licenses are not automatically renewed.
Applications for renewal shall be subject to the same terms,
information collection requirements, and approval criteria as provided
in this subpart for initial applications unless there has been an
amendment to the regulations in this part or the law since approval of
the initial or last application.
(c) License modification. A license modification is required if
there is any
[[Page 5687]]
change to the information submitted in the application including, but
not limited to, sale of a business, the production of hemp in a new
location, or a change in the key participants under a license.
(d) Licensing for research. (1) Producers that produce hemp for
research must obtain a USDA license. However, the hemp that is produced
for research and does not enter the stream of commerce is not subject
to the sampling requirements in Sec. Sec. 990.24 and 990.26; provided
that the producer adopts and carries out a USDA approved alternative
sampling method that has the potential to ensure, at a confidence level
of 95 percent, that the cannabis plant species Cannabis sativa L. that
will be subject to this alternative method will not test above the
acceptable hemp THC level.
(2) USDA licensees shall ensure the disposal of all non-compliant
plants in accordance with Sec. 990.27. Only research institutions
registered with DEA to handle marijuana can keep hemp that tests over
the 0.3 acceptable hemp THC level until the end of the study.
(3) USDA licensees shall comply with the reporting requirements in
Sec. 990.71 including reporting disposal of non-compliant plants.
Sec. 990.22 USDA hemp producer license approval.
(a) A license shall not be issued unless:
(1) The application submitted for USDA review and approval is
complete and accurate.
(2) The criminal history report(s) submitted with the license
application confirms that all key participants to be covered by the
license have not been convicted of a felony, under State or Federal
law, relating to a controlled substance within the past ten (10) years
unless the exception in Sec. 990.20(b) applies.
(3) The applicant, if the applicant was previously or is currently
licensed, submitted all reports required as a participant in the hemp
production program by this part.
(4) The application contains no materially false statements or
misrepresentations and the applicant has not previously submitted an
application with any materially false statements or misrepresentations.
(5) The applicant's license is not currently suspended, if the
applicant is currently licensed.
(6) The applicant is not applying for a license as a stand-in for
someone whose license has been suspended, revoked, or is otherwise
ineligible to participate.
(7) The State or territory of the Indian Tribe where the person
produces or intends to produce hemp does not have a USDA-approved plan
or has not submitted a plan to USDA for approval and is awaiting USDA's
decision.
(8) The State or territory of the Indian Tribe where the person
produces or intends to produce hemp does not prohibit the production of
hemp.
(b) USDA shall provide written notification to applicants whether
the application has been approved or denied. USDA shall provide written
notification to applicants in a State or territory of an Indian Tribe
that has submitted a plan to USDA and is awaiting USDA approval that
their application is being returned.
(1) If an application is approved, a license will be issued.
(2) Licenses will be valid until December 31 of the year three
after the year in which the license was issued.
(3) Licenses may not be sold, assigned, transferred, pledged, or
otherwise disposed of, alienated or encumbered.
(4) If a license application is denied, the notification from USDA
will explain the reason for denial. Applicants may appeal the denial in
accordance with subpart D of this part.
(c) If the applicant is producing in more than one State or
territory of an Indian Tribe, the applicant may have more than one
license to grow hemp. If the applicant has operations in a location
covered under a State or Tribal plan, that operation must be licensed
under the State or Tribal plan, not the USDA plan.
Sec. 990.23 Reporting hemp crop acreage with USDA Farm Service
Agency.
All USDA licensees shall report hemp crop acreage to FSA within 30
days of hemp been planted and shall provide, at a minimum, the
following information:
(a) Street address and, to the extent practicable, geospatial
location of the lot, greenhouse, building, or site where hemp will be
produced. All locations where hemp is produced must be reported to FSA.
(b) Acreage dedicated to the production of hemp, or greenhouse or
indoor square footage dedicated to the production of hemp.
(c) The hemp license number.
Sec. 990.24 Responsibility of a USDA licensee prior to harvest.
USDA licensees must:
(a) No more than 30 days prior to the anticipated harvest of
cannabis plants, have a sampling agent collect samples from the
cannabis plant for total delta-9 tetrahydrocannabinol concentration
level testing.
(b) Have samples collected from the flowering tops of the plant by
cutting the top five to eight inches from the ``main stem'' (that
includes the leaves and flowers), ``terminal bud'' (that occurs at the
end of a stem), ''or ``central cola'' (cut stem that could develop into
a bud) of the flowering top of the plant. Sampling guidelines and
training requirements for sampling agents are available from USDA. The
method used for sampling must be sufficient at a confidence level of 95
percent that no more than one percent (1%) of the plants in the lot
would exceed the acceptable hemp THC level. The method used for
sampling must ensure that a representative sample is collected that
represents a homogeneous composition of the lot.
(c) Have an authorized representative of the USDA licensee present
at the growing site during a scheduled sample collection, if possible.
(d) Ensure that sampling agents are provided with complete and
unrestricted access during business hours to all hemp and other
cannabis plants, (whether growing or harvested), all hemp production
and storage areas, all land, buildings, and other structures used for
the cultivation, handling, and storage of all hemp and other cannabis
plants, and all locations listed in the producer license.
(e) Not harvest the cannabis crop prior to samples being taken.
(f) Use post-harvest samples only for remediated biomass.
Sec. 990.25 Standards of performance for detecting total delta-9
tetrahydrocannabinol (THC) concentration levels.
Analytical testing for purposes of determining total THC in
cannabis plants shall meet the standards in this section.
(a) Laboratory quality assurance must ensure the validity and
reliability of test results.
(b) Analytical method selection, validation, and verification must
ensure that the testing method used is appropriate (fit for purpose),
and that the laboratory can successfully perform the testing.
(c) The demonstration of testing validity must ensure consistent,
accurate analytical performance.
(d) Method performance specifications must ensure analytical tests
are sufficiently sensitive for the purposes of the detectability
requirements of this part.
(e) Laboratory must have an effective disposal procedure for non-
compliant samples that do not meet the requirements of this part.
(f) Measurement of uncertainty (MU) must be estimated and reported
with
[[Page 5688]]
test results. Laboratories shall use appropriate, validated methods and
procedures for all testing activities and evaluate measurement of
uncertainty.
(g) At a minimum, analytical testing of samples for total THC must
use post-decarboxylation or other similarly reliable methods approved
by the Secretary. The testing methodology must consider the potential
conversion of THCA in hemp into THC and the test result must reflect
the total available THC derived from the sum of the THC and THCA
content. Testing methodologies meeting the requirements of this
paragraph (g) include, but are not limited to, gas or liquid
chromatography with detection.
(1) The total THC shall be determined and reported on a dry weight
basis. Additionally, measurement of uncertainty (MU) must be estimated
and reported with test results. Laboratories shall use appropriate,
validated methods and procedures for all testing activities and
evaluate measurement of uncertainty.
(2) Any sample test result exceeding the acceptable hemp THC level
shall be conclusive evidence that the lot represented by the sample is
not in compliance with this part.
(3) After December 31, 2022, USDA licensees may only use
laboratories registered with the DEA to conduct testing under this
section.
Sec. 990.26 Responsibility of a USDA producer after laboratory
testing is performed.
(a) The producer shall harvest the crop no later than thirty (30)
days after the date of sample collection.
(b) If the producer fails to complete harvest within thirty (30)
days of sample collection, a second pre-harvest sample of the lot shall
be required to be submitted for testing.
(c) Harvested lots of hemp plants shall not be commingled with
other harvested lots or other material.
(d) Lots that meet the acceptable hemp THC level may enter the
stream of commerce.
(e) Lots that do not meet the acceptable hemp THC level are subject
to Sec. 990.27.
(f) Any producer may request additional pre-harvest testing if it
is believed that the original total delta-9 tetrahydrocannabinol
concentration level test results were in error. Additional testing may
be conducted by the laboratory that conducted the initial test, or
another laboratory.
Sec. 990.27 Non-compliant cannabis plants.
(a) Cannabis plants exceeding the acceptable hemp THC level
constitute marijuana, a schedule I controlled substance under the
Controlled Substances Act (CSA), 21 U.S.C. 801 et seq., and producers
must either use a DEA-registered reverse distributor or law enforcement
to dispose of non-compliant plants or ensure the disposal of such
cannabis plant on site at the farm or hemp production facility.
(b) Producers must notify USDA of their intent to dispose of or
remediate non-conforming plants and verify disposal or remediation by
submitting required documentation.
(c) If a producer elects to perform remediation activities, an
additional sampling and testing of the post-remediated crop must occur
to determine THC concentration levels.
Sec. 990.28 Compliance.
(a) Audits. USDA licensees may be audited by the USDA. The audit
may include a review of records and documentation, and may include site
visits to farms, fields, greenhouses, storage facilities, or other
locations affiliated with the producer's hemp operation. The audit may
include the current crop year, as well as any previous crop year(s).
The audit may be performed remotely or in person.
(b) Frequency of audit verifications. Audit verifications may be
performed once every three (3) years unless otherwise determined by
USDA. If the results of the audit find negligent violations, a
corrective action plan may be established.
(c) Assessment of producer's hemp operations for conformance. The
producer's operational procedures, documentation, recordkeeping, and
other practices may be verified during the audit verification. The
auditor may also visit the production, cultivation, or storage areas
for hemp listed on the producer's license.
(1) Records and documentation. The auditor shall assess whether
required reports, records, and documentation are properly maintained
for accuracy and completeness.
(2) [Reserved]
(d) Audit reports. Audit reports will be issued to the producer no
later than 60 days after the audit is concluded. If USDA determines
through an audit that the producer is not compliant with the Act or
this part, USDA shall require a corrective action plan. The corrective
action plan must include a reasonable date by which the producer will
correct the negligent violation. USDA will approve or deny the
corrective action plan within 60 days of its receipt. Producers
operating under a corrective action plan must also periodically report
to USDA on their compliance with the plan for a period of not less than
two calendar years following the violation. The producer's
implementation of a corrective action plan may be reviewed by USDA
during a future site visit or audit. If additional instances of
noncompliance occur, USDA may revoke the producer's USDA license for
one year or until the producer becomes compliant whichever occurs
later.
Sec. 990.29 Violations.
Violations of this part shall be subject to enforcement in
accordance with the terms of this section.
(a) Negligent violations. Hemp producers are not subject to more
than one negligent violation per calendar year. A hemp producer shall
be subject to enforcement for negligently:
(1) Failing to provide an accurate legal description of land where
hemp is produced;
(2) Producing hemp without a license; and
(3) Producing cannabis exceeding the acceptable hemp THC level.
Hemp producers do not commit a negligent violation under this paragraph
(a) if they make reasonable efforts to grow hemp and the cannabis does
not have a total THC concentration of more than 1.0 percent on a dry
weight basis.
(b) Corrective action for negligent violations. For each negligent
violation, USDA will issue a Notice of Violation and require a
corrective action plan from the producer. The producer shall comply
with the corrective action plan to cure the negligent violation.
Corrective action plans will be in place for a minimum of two (2) years
from the date of their approval. Corrective action plans will, at a
minimum, include:
(1) The date by which the producer shall correct each negligent
violation;
(2) Steps that will be taken to correct each negligent violation;
and
(3) A description of the procedures that will demonstrate
compliance must be submitted to USDA.
(c) Negligent violations and criminal enforcement. A producer who
negligently violates this part shall not, as a result of that
violation, be subject to any criminal enforcement action by any
Federal, State, Tribal, or local government.
(d) Subsequent negligent violations. If a subsequent negligent
violation occurs while a corrective action plan is in place, a new
corrective action plan must be submitted with a heightened level of
quality control, staff training, and quantifiable action measures.
(e) Negligent violations and license revocation. A producer that
negligently violates the license 3 times in a 5-year
[[Page 5689]]
period shall have their license revoked and be ineligible to produce
hemp for a period of 5 years beginning on the date of the third
violation.
(f) Culpable mental state greater than negligence. If USDA
determines that a licensee has violated the terms of the license or of
this part with a culpable mental state greater than negligence:
(1) USDA shall immediately report the licensee to:
(i) The U.S. Attorney General; and
(ii) The chief law enforcement officer of the State or Indian
territory, as applicable, where the production is located; and
(2) Paragraphs (a) and (b) of this section shall not apply to
culpable violations.
Sec. 990.30 USDA producers; License suspension.
(a) USDA may issue a notice of suspension to a producer if USDA or
its representative receives some credible evidence establishing that a
producer has:
(1) Engaged in conduct violating a provision of this part; or
(2) Failed to comply with a written order from the USDA-AMS
Administrator related to negligence as defined in this part.
(b) Any producer whose license has been suspended shall not handle
or remove hemp or cannabis from the location where hemp or cannabis was
located at the time when USDA issued its notice of suspension, without
prior written authorization from USDA.
(c) Any person whose license has been suspended shall not produce
hemp during the period of suspension.
(d) A producer whose license has been suspended may appeal that
decision in accordance with subpart D of this part.
(e) A producer whose license has been suspended and not restored on
appeal may have their license restored after a waiting period of one
year from the date of the suspension. If the license was issued more
than three years prior to the date of restoration, the producer shall
submit a new application and criminal history report to USDA.
(f) A producer whose license has been suspended may be required to
provide, and operate under, a corrective action plan to fully restore
their license.
Sec. 990.31 USDA licensees; Revocation.
USDA shall immediately revoke the license of a USDA licensee if
such licensee:
(a) Pleads guilty to, or is convicted of, any felony related to a
controlled substance; or
(b) Made any materially false statement with regard to this part to
USDA or its representatives with a culpable mental state greater than
negligence; or
(c) Is found to be growing cannabis exceeding the acceptable hemp
THC level with a culpable mental state greater than negligence or
negligently violated this part three times in five years.
Sec. 990.32 Recordkeeping requirements.
(a) USDA licensees shall maintain records of all hemp plants
acquired, produced, handled, disposed of, or remediated as will
substantiate the required reports.
(b) All records and reports shall be maintained for at least three
years.
(c) All records shall be made available for inspection by USDA
inspectors, auditors, or their representatives during reasonable
business hours. The following records must be made available:
(1) Records regarding acquisition of hemp plants;
(2) Records regarding production and handling of hemp plants;
(3) Records regarding storage of hemp plants; and
(4) Records regarding disposal and remediation of all cannabis
plants that do not meet the definition of hemp.
(d) USDA inspectors, auditors, or their representatives shall have
access to any premises where hemp plants may be held during reasonable
business hours.
(e) All reports and records required to be submitted to USDA as
part of participation in the program in this part which include
confidential data or business information, including but not limited to
information constituting a trade secret or disclosing a trade position,
financial condition, or business operations of the particular licensee
or their customers, shall be received by, and at all times kept in the
custody and control of, one or more employees of USDA or their
representatives. Confidential data or business information may be
shared with applicable Federal, State, Tribal, or local law enforcement
or their designee in compliance with the Act.
Subpart D--Appeals
Sec. 990.40 General adverse action appeal process.
(a) Persons who believe they are adversely affected by the denial
of a license application under the USDA hemp production program may
appeal such decision to the AMS Administrator.
(b) Persons who believe they are adversely affected by the denial
of a license renewal under the USDA hemp production program may appeal
such decision to the AMS Administrator.
(c) Persons who believe they are adversely affected by the
revocation or suspension of a USDA hemp production license may appeal
such decision to the AMS Administrator.
(d) States and Indian Tribes that believe they are adversely
affected by the denial of a proposed State or Tribal hemp plan may
appeal such decision to the AMS Administrator.
Sec. 990.41 Appeals under the USDA hemp production plan.
(a) Appealing a denied USDA-plan license application. A license
applicant may appeal the denial of a license application.
(1) If the AMS Administrator grants an applicant's appeal of a
licensing denial, the applicant will be issued a USDA hemp production
license.
(2) If the AMS Administrator denies an appeal, the applicant's
license application will be denied. The applicant may request a formal
adjudicatory proceeding within 30 days to review the decision. Such
proceeding shall be conducted pursuant to the U.S. Department of
Agriculture's Rules of Practice Governing Adjudicatory Proceedings, 7
CFR part 1, subpart H.
(b) Appealing a denied USDA-plan license renewal. A producer may
appeal the denial of a license renewal.
(1) If the AMS Administrator grants a producer's appeal of a
licensing renewal denial, the applicant's USDA hemp production license
will be renewed.
(2) If the AMS Administrator denies the appeal, the applicant's
license will not be renewed. The denied producer may request a formal
adjudicatory proceeding within 30 days to review the decision. Such
proceeding shall be conducted pursuant to the U.S. Department of
Agriculture's Rules of Practice Governing Formal Adjudicatory
Proceedings, 7 CFR part 1, subpart H.
(c) Appealing a USDA-plan license termination or suspension. A USDA
hemp plan producer may appeal the revocation or suspension of a
license.
(1) If the AMS Administrator grants the appeal of a license
termination or suspension, the producer will retain their license.
(2) If the AMS Administrator denies the appeal, the producer's
license will be terminated or suspended. The producer may request a
formal adjudicatory proceeding within 30 days to review the decision.
Such proceeding shall be conducted pursuant to the U.S. Department of
Agriculture's Rules of Practice Governing Formal Adjudicatory
Proceedings, 7 CFR part 1, subpart H.
[[Page 5690]]
(d) Filing period. The appeal of a denied license application,
denied license renewal, suspension, or revocation must be filed within
the time-period provided in the letter of notification or within 30
business days from receipt of the notification, whichever occurs later.
The appeal will be considered ``filed'' on the date received by the AMS
Administrator. The decision to deny an appeal of a license application
or renewal, or suspend or terminate a license, is final unless a formal
adjudicatory proceeding is requested within 30 days to review the
decision. Such proceeding shall be conducted pursuant to the U.S.
Department of Agriculture's Rules of Practice Governing Adjudicatory
Proceedings, 7 CFR part 1, subpart H.
(e) Where to file. Appeals to the Administrator must be filed in
the manner as determined by AMS.
(f) What to include. All appeals must include a copy of the adverse
decision and a statement of the appellant's reasons supporting why the
decision was not proper or made in accordance with applicable program
regulations in this part, policies, or procedures.
Sec. 990.42 Appeals under a State or Tribal hemp production plan.
(a) Appealing a State or Tribal hemp production plan application. A
State or Indian Tribe may appeal the denial of a proposed State or
Tribal hemp production plan by the USDA to the AMS Administrator.
(1) If the AMS Administrator grants a State or Indian Tribe's
appeal of a denied hemp plan application, the proposed State or Tribal
hemp production plan shall be established as proposed.
(2) If the AMS Administrator denies an appeal, the proposed State
or Tribal hemp production plan shall not be approved. Prospective
producers located in the State or territory of the Indian Tribe may
apply for hemp licenses under the terms of the USDA plan. The State or
Indian Tribe may request a formal adjudicatory proceeding be initiated
within 30 days to review the decision. Such proceeding shall be
conducted pursuant to the U.S. Department of Agriculture's Rules of
Practice Governing Adjudicatory Proceedings, 7 CFR part 1, subpart H.
(b) Appealing the suspension or termination of a State or Tribal
hemp production plan. A State or Tribe may appeal the revocation by
USDA of an approved State or Tribal hemp production plan.
(1) If the AMS Administrator grants a State or Indian Tribe's
appeal of a State or Tribal hemp production plan suspension or
revocation, the associated hemp production plan will remain in place
and effective.
(2) If the AMS Administrator denies an appeal, the State or Tribal
hemp production plan will be suspended or revoked as applicable.
Producers located in that State or territory of the Indian Tribe may
continue to produce hemp under their State or Tribal license until the
end the calendar year in which the State or Tribal plan's disapproval
was effective or when the State or Tribal license expires, whichever is
earlier. Producers may apply for a USDA license under subpart C of this
part unless hemp production is otherwise prohibited by the State or
Indian Tribe. The State or Indian Tribe may request a formal
adjudicatory proceeding be initiated to review the decision. Such
proceeding shall be conducted pursuant to the U.S. Department of
Agriculture's Rules of Practice Governing Formal Adjudicatory
Proceedings, 7 CFR part 1, subpart H.
(c) Filing period. The appeal of a State or Tribal hemp production
plan suspension or revocation must be filed within the time-period
provided in the letter of notification or within 30 business days from
receipt of the notification, whichever occurs later. The appeal will be
considered ``filed'' on the date received by the AMS Administrator. The
decision to deny a State or Tribal plan application or suspend or
revoke approval of a plan, is final unless the decision is appealed in
a timely manner.
(d) Where to file. Appeals to the Administrator must be filed in
the manner as determined by AMS.
(e) What to include in appeal. All appeals must include a copy of
the adverse decision and a statement of the appellant's reasons
supporting why the decision was not proper or made in accordance with
applicable program regulations in this part, policies, or procedures.
Subpart E--Administrative Provisions
Sec. 990.60 Agents.
As provided under 7 CFR part 2, the Secretary may name any officer
or employee of the United States or name any agency or division in the
United States Department of Agriculture, to act as their agent or
representative in connection with any of the provisions of this part.
Sec. 990.61 Severability.
If any provision of this part is declared invalid or the
applicability thereof to any person or circumstances is held invalid,
the validity of the remainder of this part or the applicability thereof
to other persons or circumstances shall not be affected thereby.
Sec. 990.62 [Reserved]
Sec. 990.63 Interstate transportation of hemp.
No State or Indian Tribe may prohibit the transportation or
shipment of hemp lawfully produced under a State or Tribal plan
approved under subpart B of this part, under a license issued under
subpart C of this part, or under 7 U.S.C. 5940 through the State or
territory of the Indian Tribe, as applicable.
Subpart F--Reporting Requirements
Sec. 990.70 State and Tribal hemp reporting requirements.
(a) State and Tribal hemp producer report. Each State and Indian
Tribe with a plan approved under this part shall submit to USDA, by the
first of each month, a report providing the contact information and the
status of the license or other authorization issued for each producer
covered under the applicable State and Tribal plans. If the first of
the month falls on a weekend or holiday, the report is due by the first
business day following the due date. The report shall be submitted
using a digital format compatible with USDA's information sharing
systems, whenever possible. The report shall contain the information
described in this paragraph (a).
(1)(i) For each new producer who is an individual and is licensed
or authorized under the State or Tribal plan, the report shall include
the full name of the individual, license or authorization identifier,
Employee Identification Number (``EIN'') of the business entity,
business address, telephone number, and email address (if available).
(ii) For each new producer that is an entity and is licensed or
authorized under the State or Tribal plan, the report shall include
full name of the entity, the principal business location address,
license or authorization identifier, and the full name, title, and
email address (if available) of each employee for whom the entity is
required to submit a criminal history report.
(iii) For each producer that was included in a previous report and
whose reported information has changed, the report shall include the
previously reported information and the new information.
(2) The status of each producer's license or authorization.
(3) The period covered by the report.
(4) Indication that there were no changes during the current
reporting cycle, if applicable.
[[Page 5691]]
(b) State and Tribal hemp disposal or remediation report. If a
producer has produced cannabis exceeding the acceptable hemp THC level,
the cannabis must be disposed of or remediated. States and Tribes with
plans approved under this part shall submit to USDA, by the first of
each month, a report notifying USDA of any occurrence of non-conforming
plants or plant material and providing a disposal or remediation record
of those plants and materials. This report would include information
regarding name and contact information for each producer subject to a
disposal or remediation during the reporting period, and date disposal
or remediation was completed. If the first of the month fall on a
weekend or holiday, reports are due by the first business day following
the due date. The report shall contain the information described in
this paragraph (b).
(1) Name and address of the producer.
(2) Producer license or authorization identifier.
(3) Location information, such as lot number, location type, and
geospatial location or other location descriptor for the production
area subject to disposal or remediation.
(4) Disposal or remediation completion date.
(5) Total acreage.
(c) Annual report. Each State or Indian Tribe with a plan approved
under this part shall submit an annual report to USDA. The report form
shall be submitted by December 15 of each year and contain the
information described in this paragraph (c).
(1) Total planted acreage.
(2) Total harvested acreage.
(3) Total acreage disposed and remediated.
(d) Test results report. Each producer must ensure that the
laboratory that conducts the test of the sample(s) from its lots
reports the test results to USDA. Informal testing conducted throughout
the growing season for purposes of monitoring THC concentration do not
need to be reported to USDA. The test results report shall contain:
(1) Producer's license or authorization identifier.
(2) Name of producer.
(3) Business address of producer.
(4) Lot identification number for the sample.
(5) Name of laboratory and, no later than December 31, 2022, the
DEA registration number of laboratory for testing.
(6) Date of test and report.
(7) Identification of a pre-harvest or post-harvest retest.
(8) Test result.
Sec. 990.71 USDA plan reporting requirements.
(a) USDA licensing application. USDA will accept applications on a
rolling basis. Licenses will be valid until December 31 of the year
three years after the license is issued. The license application will
be used for both new and renewal applicants. The application shall
include:
(1) Contact information. (i) For an applicant who is an individual,
the application shall include full name of the individual, Employee
Identification Number (``EIN'') of the business entity, business
address, telephone number, and email address (if available).
(ii) For an applicant that is an entity, the application shall
include full name of the entity, the principal business location
address, and the full name, title, and email address (if available) of
each key participant of the entity.
(2) Criminal history report. As part of a complete application,
each applicant shall provide a current Federal Bureau of
Investigation's Identity History Summary. If the applicant is a
business entity, a criminal history report shall be provided for each
key participant.
(i) The applicant shall ensure the criminal history report
accompanies the application.
(ii) The criminal history report must be dated within 60 days of
submission of the application submittal.
(3) Consent to comply with program requirements. All applicants
submitting a completed license application, in doing so, consent to
comply with the requirements of this part.
(b) USDA licensee disposal and remediation form. USDA licensee
conducts a disposal or remediation activity, that licensee must report
the activity on the appropriate form to USDA no later than 30 days
after the date of completion of disposal or remediation activity. The
report shall contain the information described in this paragraph (b).
(1) Name and address of the producer.
(2) The USDA licensee's USDA license number.
(3) Geospatial location, or other valid land descriptor, for the
production area subject to disposal or remediation.
(4) Date of completion of disposal or remediation.
(5) Signature of the USDA licensee or authorized representative.
(c) USDA licensee annual report. Each USDA licensee shall submit an
annual report to USDA. The report form shall be submitted by December
15 of each year and contain the information described in this paragraph
(c).
(1) USDA licensee 's license number.
(2) USDA licensee 's name.
(3) USDA licensee's address.
(4) Lot, location type, geospatial location, total planted acreage,
total acreage disposed and remediated, and total harvested acreage.
(d) Test results report. Each USDA licensee must ensure that the
laboratory that conducts the test of the sample(s) from its lots
reports the test results for all samples tested to USDA. Informal
testing conducted throughout the growing season for purposes of
monitoring THC concentration do not need to be reported to USDA. The
test results report shall contain the information described in this
paragraph (d) for each sample tested.
(1) USDA licensee 's license number.
(2) Name of the USDA licensee.
(3) Business address of the USDA licensee.
(4) Lot identification number for the sample.
(5) Name of testing laboratory.
(6) Date of test and report.
(7) Identification of a pre-harvest or post-harvest retest.
(8) Test result.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2021-00967 Filed 1-15-21; 8:45 am]
BILLING CODE P
