Document ID: FDA-2016-S-0009-0003
Agency: fda
Document Type: Notice
Title: Statement of Principles on Industrial Hemp
Posted Date: 2016-08-12T04:00Z

[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Notices]
[Pages 53395-53396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19146]

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 Notices
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 This section of the FEDERAL REGISTER contains documents other than rules 
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  Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / 
Notices  

[[Page 53395]]

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

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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 and

[[Page 53396]]

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]
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