https://www.federalregister.gov/documents/2016/08/12/2016-19146/statement-of-principles-on-industrial-hemp

AGENCY:

Office of the Secretary, USDA; Drug Enforcement Administration, DOJ; Food and Drug Administration, HHS.

ACTION:

Notice

SUMMARY:

The U.S. Department of Agriculture, in consultation with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, has developed a Statement of Principles on Industrial Hemp to inform the public how Federal law applies to activities associated with industrial hemp that is grown and cultivated in accordance with Section 7606 of the Agricultural Act of 2014. The purpose of this notice is to set forth the statement in its entirety.

DATES:

This Statement of Principles is applicable August 12, 2016.

FOR FURTHER INFORMATION CONTACT:

Michael Poe, Telephone Number:(202) 720-3257.

SUPPLEMENTARY INFORMATION:

1. Statement of Principles

With publication of this notice, the U.S. Department of Agriculture (USDA) issues, with the concurrence of the U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA), the following Statement of Principles regarding the applicability of Federal laws to activities associated with growing and cultivating industrial hemp:

Section 7606 of the Agricultural Act of 2014 legalized the growing and cultivating of industrial hemp for research purposes in States where such growth and cultivation is legal under State law, notwithstanding existing Federal statutes that would otherwise criminalize such conduct. The statutorily sanctioned conduct, however, was limited to growth and cultivation by an institution of higher education or State department of agriculture for purposes of agricultural or other academic research or under the auspices of a State agricultural pilot program for the growth, cultivation, or marketing of industrial hemp.

Section 7606 authorized State departments of agriculture to promulgate regulations to carry out these pilot programs but did not provide a specific delegation to the U.S. Department of Agriculture (USDA) or any other agency to implement the program. As well, the statute left open many questions regarding the continuing application of Federal drug control statutes to the growth, cultivation, manufacture, and distribution of industrial hemp products, as well as the extent to which growth by private parties and sale of industrial hemp products are permissible. Section 7606 did not remove industrial hemp from the controlled substances list. Therefore, Federal law continues to restrict hemp-related activities, to the extent that those activities have not been legalized under section 7606.

USDA, having consulted with and received concurrence from the U.S. Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA), therefore, is issuing this statement of principles to inform the public regarding how Federal law applies to activities involving industrial hemp so that individuals, institutions, and States that wish to participate in industrial hemp agricultural pilot programs can do so in accordance with Federal law.

• The growth and cultivation of industrial hemp may only take place in accordance with an agricultural pilot program to study the growth, cultivation, or marketing of industrial hemp established by a State department of agriculture or State agency responsible for agriculture in a State where the production of industrial hemp is otherwise legal under State law.
• The State agricultural pilot program must provide for State registration and certification of sites used for growing or cultivating industrial hemp. Although registration and certification is not further defined, it is recommended that such registration should include the name of the authorized manufacturer, the period of licensure or other time period during which such person is authorized by the State to manufacture industrial hemp, and the location, including Global Positioning System coordinates, where such person is authorized to manufacture industrial hemp.
• Only State departments of agriculture, and persons licensed, registered, or otherwise authorized by them to conduct research under an agricultural pilot program in accordance with section 7606, and institutions of higher education (as defined in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001)), or persons employed by or under a production contract or lease with them to conduct such research, may grow or cultivate industrial hemp as part of the agricultural pilot program.
• The term “industrial hemp” includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis. The term “tetrahydrocannabinols” includes all isomers, acids, salts, and salts of isomers of tetrahydrocannabinols.
• For purposes of marketing research by institutions of higher education or State departments of agriculture (including distribution of marketing materials), but not for the purpose of general commercial activity, industrial hemp products may be sold in a State with an agricultural pilot program or among States with agricultural pilot programs but may not be sold in States where such sale is prohibited. Industrial hemp plants and seeds may not be transported across State lines.
• Section 7606 specifically authorized certain entities to “grow or cultivate” industrial hemp but did not eliminate the requirement under the Controlled Substances Import andStart Printed Page 53396Export Act that the importation of viable cannabis seeds must be carried out by persons registered with the DEA to do so. In addition, any USDA phytosanitary requirements that normally would apply to the importation of plant material will apply to the importation of industrial hemp seed.
• Section 7606 did not amend the Federal Food, Drug, and Cosmetic Act. For example, section 7606 did not alter the approval process for new drug applications, the requirements for the conduct of clinical or nonclinical research, the oversight of marketing claims, or any other authorities of the FDA as they are set forth in that Act.
• The Federal Government does not construe section 7606 to alter the requirements of the Controlled Substances Act (CSA) that apply to the manufacture, distribution, and dispensing of drug products containing controlled substances. Manufacturers, distributors, dispensers of drug products derived from cannabis plants, as well as those conducting research with such drug products, must continue to adhere to the CSA requirements.
• Institutions of higher education and other participants authorized to carry out agricultural pilot programs under section 7606 may be able to participate in USDA research or other programs to the extent otherwise eligible for participation in those programs.

2. Regulatory Requirements

This Statement of Principles does not establish any binding legal requirements. It is, therefore, exempt from notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b). Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis. 5 U.S.C. 603(a), 604(a). USDA has determined that this Statement of Principles does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501, et seq.

 

https://www.gpo.gov/fdsys/pkg/FR-2016-08-12/pdf/2016-19146.pdf

Federal Register
53395
Vol. 81, No. 156
Friday, August 12, 2016

DEPARTMENT OF AGRICULTURE
Office of the Secretary
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Principles on Industrial
Hemp
AGENCY: Office of the Secretary, USDA;
Drug Enforcement Administration, DOJ;
Food and Drug Administration, HHS.
ACTION: Notice
SUMMARY: The U.S. Department of
Agriculture, in consultation with the
U.S. Drug Enforcement Administration
and the U.S. Food and Drug
Administration, has developed a
Statement of Principles on Industrial
Hemp to inform the public how Federal
law applies to activities associated with
industrial hemp that is grown and
cultivated in accordance with Section
7606 of the Agricultural Act of 2014.
The purpose of this notice is to set forth
the statement in its entirety.
DATES: This Statement of Principles is
applicable August 12, 2016.
FOR FURTHER INFORMATION CONTACT:
Michael Poe, Telephone Number:
(202) 720–3257.
SUPPLEMENTARY INFORMATION:
1. Statement of Principles
With publication of this notice, the
U.S. Department of Agriculture (USDA)
issues, with the concurrence of the U.S.
Drug Enforcement Administration
(DEA) and the U.S. Food and Drug
Administration (FDA), the following
Statement of Principles regarding the
applicability of Federal laws to
activities associated with growing and
cultivating industrial hemp:
Section 7606 of the Agricultural Act
of 2014 legalized the growing and
cultivating of industrial hemp for
research purposes in States where such
growth and cultivation is legal under
State law, notwithstanding existing
Federal statutes that would otherwise
criminalize such conduct. The
statutorily sanctioned conduct,
however, was limited to growth and
cultivation by an institution of higher
education or State department of
agriculture for purposes of agricultural
or other academic research or under the
auspices of a State agricultural pilot
program for the growth, cultivation, or
marketing of industrial hemp.
Section 7606 authorized State
departments of agriculture to
promulgate regulations to carry out
these pilot programs but did not provide
a specific delegation to the U.S.
Department of Agriculture (USDA) or
any other agency to implement the
program. As well, the statute left open
many questions regarding the
continuing application of Federal drug
control statutes to the growth,
cultivation, manufacture, and
distribution of industrial hemp
products, as well as the extent to which
growth by private parties and sale of
industrial hemp products are
permissible. Section 7606 did not
remove industrial hemp from the
controlled substances list. Therefore,
Federal law continues to restrict hemprelated
activities, to the extent that those
activities have not been legalized under
section 7606.
USDA, having consulted with and
received concurrence from the U.S.
Drug Enforcement Administration
(DEA) and the U.S. Food and Drug
Administration (FDA), therefore, is
issuing this statement of principles to
inform the public regarding how Federal
law applies to activities involving
industrial hemp so that individuals,
institutions, and States that wish to
participate in industrial hemp
agricultural pilot programs can do so in
accordance with Federal law.
• The growth and cultivation of
industrial hemp may only take place in
accordance with an agricultural pilot
program to study the growth,
cultivation, or marketing of industrial
hemp established by a State department
of agriculture or State agency
responsible for agriculture in a State
where the production of industrial
hemp is otherwise legal under State law.
• The State agricultural pilot program
must provide for State registration and
certification of sites used for growing or
cultivating industrial hemp. Although
registration and certification is not
further defined, it is recommended that
such registration should include the
name of the authorized manufacturer,
the period of licensure or other time
period during which such person is
authorized by the State to manufacture
industrial hemp, and the location,
including Global Positioning System
coordinates, where such person is
authorized to manufacture industrial
hemp.
• Only State departments of
agriculture, and persons licensed,
registered, or otherwise authorized by
them to conduct research under an
agricultural pilot program in accordance
with section 7606, and institutions of
higher education (as defined in section
101 of the Higher Education Act of 1965
(20 U.S.C. 1001)), or persons employed
by or under a production contract or
lease with them to conduct such
research, may grow or cultivate
industrial hemp as part of the
agricultural pilot program.
• The term ‘‘industrial hemp’’
includes the plant Cannabis sativa L.
and any part or derivative of such plant,
including seeds of such plant, whether
growing or not, that is used exclusively
for industrial purposes (fiber and seed)
with a tetrahydrocannabinols
concentration of not more than 0.3
percent on a dry weight basis. The term
‘‘tetrahydrocannabinols’’ includes all
isomers, acids, salts, and salts of
isomers of tetrahydrocannabinols.
• For purposes of marketing research
by institutions of higher education or
State departments of agriculture
(including distribution of marketing
materials), but not for the purpose of
general commercial activity, industrial
hemp products may be sold in a State
with an agricultural pilot program or
among States with agricultural pilot
programs but may not be sold in States
where such sale is prohibited. Industrial
hemp plants and seeds may not be
transported across State lines.
• Section 7606 specifically
authorized certain entities to ‘‘grow or
cultivate’’ industrial hemp but did not
eliminate the requirement under the
Controlled Substances Import and

Export Act that the importation of viable
cannabis seeds must be carried out by
persons registered with the DEA to do
so. In addition, any USDA phytosanitary
requirements that normally would apply
to the importation of plant material will
apply to the importation of industrial
hemp seed.
• Section 7606 did not amend the
Federal Food, Drug, and Cosmetic Act.
For example, section 7606 did not alter
the approval process for new drug
applications, the requirements for the
conduct of clinical or nonclinical
research, the oversight of marketing
claims, or any other authorities of the
FDA as they are set forth in that Act.
• The Federal Government does not
construe section 7606 to alter the
requirements of the Controlled
Substances Act (CSA) that apply to the
manufacture, distribution, and
dispensing of drug products containing
controlled substances. Manufacturers,
distributors, dispensers of drug products
derived from cannabis plants, as well as
those conducting research with such
drug products, must continue to adhere
to the CSA requirements.
• Institutions of higher education and
other participants authorized to carry
out agricultural pilot programs under
section 7606 may be able to participate
in USDA research or other programs to
the extent otherwise eligible for
participation in those programs.
2. Regulatory Requirements
This Statement of Principles does not
establish any binding legal
requirements. It is, therefore, exempt
from notice and comment rulemaking
requirements under the Administrative
Procedure Act pursuant to 5 U.S.C.
553(b). Because no notice of proposed
rulemaking is required, the Regulatory
Flexibility Act does not require an
initial or final regulatory flexibility
analysis. 5 U.S.C. 603(a), 604(a). USDA
has determined that this Statement of
Principles does not impose any new or
revise any existing recordkeeping,
reporting, or disclosure requirements on
covered entities or members of the
public that would be collections of
information requiring OMB approval
under the Paperwork Reduction Act, 44
U.S.C. 3501, et seq.
Dated: July 25, 2016.
Thomas J. Vilsack,
Secretary of Agriculture.
Dated: July 21, 2016.
Louis J. Milione,
Deputy Assistant Administrator, Drug
Enforcement Administration.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and
Drug Administration.
[FR Doc. 2016–19146 Filed 8–11–16; 8:45 am]
BILLING CODE 3410–01–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2016–0043]
Okanagan Specialty Fruits, Inc.;
Availability of Preliminary Finding of
No Significant Impact, Preliminary
Plant Pest Risk Similarity Assessment,
and Preliminary Determination for an
Extension of a Determination of
Nonregulated Status for Non-Browning
Arctic® Apple Event NF872 Apple
AGENCY: Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
SUMMARY: We are advising the public
that the Animal and Plant Health
Inspection Service has reached a
preliminary decision to extend our
determination of nonregulated status of
Okanagan Specialty Fruits’ (OSF) GS784
and GD743 apples to OSF NF872
‘Arctic® Fuji apple’. OSF’s NF872 apple
has been genetically engineered for
enzymatic browning resistance using
the same mode of action as GS784 and
GD743 apples. We are making available
for public comment our preliminary
determination, preliminary plant pest
risk similarity assessment, and
preliminary finding of no significant
impact for the proposed determination
of nonregulated status.
DATES: We will consider all comments
that we receive on or before September
12, 2016.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov/
#!docketDetail;D=APHIS-2016-0043.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2016–0043, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The Okanagan Specialty Fruits
extension request, our preliminary
determination, preliminary plant pest
risk similarity assessment, preliminary
finding of no significant impact, and
any comments we receive on this docket
may be viewed at http://
www.regulations.gov/
#!docketDetail;D=APHIS-2016-0043 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue
SW., Washington, DC. Normal reading
room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
Supporting documents and any
comments we received regarding our
determination of nonregulated status of
the antecedent organisms (apple events
GD743 and GS784), can be found at
http://www.regulations.gov/
#!docketDetail;D=APHIS-2012-0025.
Supporting documents may also be
found on the APHIS Web site for NF872
‘Arctic® Fuji apple’ (the organism under
evaluation) under APHIS Petition
Number 16–004–01p, and the
antecedent organisms (apple events
GD743 and GS784) under APHIS
Petition Number 10–161–01p.
FOR FURTHER INFORMATION CONTACT: Dr.
John Turner, Director, Biotechnology
Risk Analysis Programs, Biotechnology
Regulatory Services, APHIS, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 851–3954, email:
john.t.turner@aphis.usda.gov. To obtain
copies of the supporting documents,
contact Ms. Cindy Eck at (301) 851–
3885, email: cynthia.a.eck@
aphis.usda.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of the plant pest provisions of
the Plant Protection Act (PPA) (7 U.S.C.
7701 et seq.), the regulations in 7 CFR
part 340, ‘‘Introduction of Organisms
and Products Altered or Produced
Through Genetic Engineering Which
Are Plant Pests or Which There Is
Reason to Believe Are Plant Pests,’’
regulate, among other things, the
introduction (importation, interstate
movement, or release into the
environment) of organisms and products
altered or produced through genetic
engineering that are plant pests or that
there is reason to believe are plant pests.
Such genetically engineered organisms
and products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Further, the regulations in § 340.6(e)(2)
provide that a person may request that
APHIS extend a determination of
nonregulated status to other organisms.
Such a request must include
information to establish the similarity of
the antecedent organism and the
regulated article in question.