81 FR 53395 - Statement of Principles on Industrial Hemp
DEPARTMENT OF AGRICULTURE
Office of the Secretary
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 156 (August 12, 2016)
Office of the Secretary
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Federal Register Volume 81, Issue 156 (August 12, 2016)
| Page Range | 53395-53396 | |
| FR Document | 2016-19146 |
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)] [Notices] [Pages 53395-53396] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19146] ======================================================================== Notices Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains documents other than rules or proposed rules that are applicable to the public. Notices of hearings and investigations, committee meetings, agency decisions and rulings, delegations of authority, filing of petitions and applications and agency statements of organization and functions are examples of documents appearing in this section. ======================================================================== 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 ----------------------------------------------------------------------- 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] BILLING CODE 3410-01-P
![53396 Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Notices
Export Act that the importation of viable Dated: July 22, 2016. room 1141 of the USDA South Building,
cannabis seeds must be carried out by Leslie Kux, 14th Street and Independence Avenue
persons registered with the DEA to do Associate Commissioner for Policy, Food and SW., Washington, DC. Normal reading
so. In addition, any USDA phytosanitary Drug Administration. room hours are 8 a.m. to 4:30 p.m.,
requirements that normally would apply [FR Doc. 2016–19146 Filed 8–11–16; 8:45 am] Monday through Friday, except
to the importation of plant material will BILLING CODE 3410–01–P holidays. To be sure someone is there to
apply to the importation of industrial help you, please call (202) 799–7039
hemp seed. before coming.
• Section 7606 did not amend the DEPARTMENT OF AGRICULTURE Supporting documents and any
Federal Food, Drug, and Cosmetic Act. comments we received regarding our
Animal and Plant Health Inspection determination of nonregulated status of
For example, section 7606 did not alter Service
the approval process for new drug the antecedent organisms (apple events
applications, the requirements for the [Docket No. APHIS–2016–0043] GD743 and GS784), can be found at
conduct of clinical or nonclinical http://www.regulations.gov/
Okanagan Specialty Fruits, Inc.; #!docketDetail;D=APHIS-2012-0025.
research, the oversight of marketing
Availability of Preliminary Finding of Supporting documents may also be
claims, or any other authorities of the
No Significant Impact, Preliminary found on the APHIS Web site for NF872
FDA as they are set forth in that Act.
Plant Pest Risk Similarity Assessment, ‘Arctic® Fuji apple’ (the organism under
• The Federal Government does not and Preliminary Determination for an evaluation) under APHIS Petition
construe section 7606 to alter the Extension of a Determination of Number 16–004–01p, and the
requirements of the Controlled Nonregulated Status for Non-Browning antecedent organisms (apple events
Substances Act (CSA) that apply to the Arctic® Apple Event NF872 Apple GD743 and GS784) under APHIS
manufacture, distribution, and Petition Number 10–161–01p.
dispensing of drug products containing AGENCY: Animal and Plant Health
Inspection Service, USDA. FOR FURTHER INFORMATION CONTACT: Dr.
controlled substances. Manufacturers,
ACTION: Notice. John Turner, Director, Biotechnology
distributors, dispensers of drug products
Risk Analysis Programs, Biotechnology
derived from cannabis plants, as well as SUMMARY: We are advising the public Regulatory Services, APHIS, 4700 River
those conducting research with such that the Animal and Plant Health Road Unit 147, Riverdale, MD 20737–
drug products, must continue to adhere Inspection Service has reached a 1236; (301) 851–3954, email:
to the CSA requirements. preliminary decision to extend our john.t.turner@aphis.usda.gov. To obtain
• Institutions of higher education and determination of nonregulated status of copies of the supporting documents,
other participants authorized to carry Okanagan Specialty Fruits’ (OSF) GS784 contact Ms. Cindy Eck at (301) 851–
out agricultural pilot programs under and GD743 apples to OSF NF872 3885, email: cynthia.a.eck@
section 7606 may be able to participate ‘Arctic® Fuji apple’. OSF’s NF872 apple aphis.usda.gov.
in USDA research or other programs to has been genetically engineered for
the extent otherwise eligible for enzymatic browning resistance using SUPPLEMENTARY INFORMATION: Under the
participation in those programs. the same mode of action as GS784 and authority of the plant pest provisions of
GD743 apples. We are making available the Plant Protection Act (PPA) (7 U.S.C.
2. Regulatory Requirements for public comment our preliminary 7701 et seq.), the regulations in 7 CFR
determination, preliminary plant pest part 340, ‘‘Introduction of Organisms
This Statement of Principles does not and Products Altered or Produced
establish any binding legal risk similarity assessment, and
preliminary finding of no significant Through Genetic Engineering Which
requirements. It is, therefore, exempt Are Plant Pests or Which There Is
from notice and comment rulemaking impact for the proposed determination
of nonregulated status. Reason to Believe Are Plant Pests,’’
requirements under the Administrative regulate, among other things, the
Procedure Act pursuant to 5 U.S.C. DATES: We will consider all comments
that we receive on or before September introduction (importation, interstate
553(b). Because no notice of proposed movement, or release into the
rulemaking is required, the Regulatory 12, 2016.
environment) of organisms and products
Flexibility Act does not require an ADDRESSES: You may submit comments
altered or produced through genetic
initial or final regulatory flexibility by either of the following methods:
engineering that are plant pests or that
analysis. 5 U.S.C. 603(a), 604(a). USDA • Federal eRulemaking Portal: Go to
there is reason to believe are plant pests.
has determined that this Statement of http://www.regulations.gov/
Such genetically engineered organisms
Principles does not impose any new or #!docketDetail;D=APHIS-2016-0043.
• Postal Mail/Commercial Delivery: and products are considered ‘‘regulated
revise any existing recordkeeping, articles.’’
reporting, or disclosure requirements on Send your comment to Docket No.
APHIS–2016–0043, Regulatory Analysis The regulations in § 340.6(a) provide
covered entities or members of the that any person may submit a petition
public that would be collections of and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118, to the Animal and Plant Health
information requiring OMB approval Inspection Service (APHIS) seeking a
under the Paperwork Reduction Act, 44 Riverdale, MD 20737–1238.
The Okanagan Specialty Fruits determination that an article should not
U.S.C. 3501, et seq. be regulated under 7 CFR part 340.
extension request, our preliminary
Dated: July 25, 2016. determination, preliminary plant pest Further, the regulations in § 340.6(e)(2)
mstockstill on DSK3G9T082PROD with NOTICES
Thomas J. Vilsack, risk similarity assessment, preliminary provide that a person may request that
Secretary of Agriculture. finding of no significant impact, and APHIS extend a determination of
any comments we receive on this docket nonregulated status to other organisms.
Dated: July 21, 2016. may be viewed at http:// Such a request must include
Louis J. Milione, www.regulations.gov/ information to establish the similarity of
Deputy Assistant Administrator, Drug #!docketDetail;D=APHIS-2016-0043 or the antecedent organism and the
Enforcement Administration. in our reading room, which is located in regulated article in question.
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Document Created: 2018-02-09 11:33:12
Document Modified: 2018-02-09 11:33:12
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice | |
| Dates | This Statement of Principles is applicable August 12, 2016. | |
| Contact | Michael Poe, Telephone Number: (202) 720-3257. | |
| FR Citation | 81 FR 53395 |
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