[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60414-60416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25325]
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SCIENCE AND TECHNOLOGY POLICY OFFICE
Clarifying Current Roles and Responsibilities Described in the
Coordinated Framework for the Regulation of Biotechnology and
Developing a Long-Term Strategy for the Regulation of the Products of
Biotechnology
AGENCY: National Science and Technology Council, Science and Technology
Policy Office.
ACTION: Notice of request for information.
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SUMMARY: On July 2, 2015, the Executive Office of the President (EOP)
issued a memorandum (Ref. 1) directing the primary agencies that
regulate the products of biotechnology--the U.S. Environmental
Protection Agency (EPA), the Food and Drug Administration (FDA), and
the U.S. Department of Agriculture (USDA)--to update the Coordinated
Framework for the Regulation of Biotechnology (51 FR 23302; June 26,
1986) (Ref. 2), develop a long-term strategy to ensure that the Federal
biotechnology regulatory system is prepared for the future products of
biotechnology, and commission an expert analysis of the future
landscape of biotechnology products to support this effort. The
memorandum's objectives are to ensure public confidence in the
regulatory system and to prevent unnecessary barriers to future
innovation and competitiveness by improving the transparency,
coordination, predictability, and efficiency of the regulation of
biotechnology products while continuing to protect health and the
environment.
The purpose of this Request for Information (RFI) is to solicit
relevant data and information, including case studies, that can assist
in the development of the proposed update to the Coordinated Framework
for the Regulation of Biotechnology (CF) to clarify the current roles
and responsibilities of the EPA, FDA, and USDA and the development of a
long-term strategy consistent with the objectives described in the July
2, 2015 EOP memorandum. In addition to this RFI, the update to the CF
will undergo public comment before it is finalized.
DATES: Responses must be received by November 13, 2015 at 5:00 p.m. EST
to be considered.
ADDRESSES: You may submit information by either of the following
methods (electronic is strongly preferred):
Federal eRulemaking Portal: http://www.regulations.gov.
Docket No. FDA-2015-N-3403. Follow the instructions for submitting
information. Information submitted electronically, including
attachments, to http://www.regulations.gov will be posted to the docket
unchanged.
Mail: National Science and Technology Council: Emerging
Technologies Interagency Policy Coordination Committee, Office of
Science and Technology Policy, 1650 Pennsylvania Avenue NW.,
Washington, DC 20504. If submitting a response by mail, please allow
sufficient time for mail processing. Written/paper information,
including attachments, will be posted to the docket unchanged.
Instructions: All submissions received must include Docket No. FDA-
2015-N-3403 for Clarifying Current Roles and Responsibilities Described
in the Coordinated Framework for the Regulation of Biotechnology and
Developing a Long-Term Strategy for the Regulation of the Products of
Biotechnology; Request for Information.
Disclaimer: All information received will be placed in the docket
and will be publicly viewable at http://www.regulations.gov. Responses
must be unclassified and should not contain any information that might
be considered proprietary, confidential, or personally identifying
(such as home address or social security number).
Responses to this RFI will not be returned. The National Science
and Technology Council is under no obligation to acknowledge receipt of
the information received, or provide feedback to respondents with
respect to any information submitted under this RFI. No requests for a
bid package or solicitation will be accepted; no bid package or
solicitation exists. This RFI is issued solely for information and
planning purposes and does not constitute a solicitation.
FOR FURTHER INFORMATION CONTACT: National Science and Technology
Council: Emerging Technologies Interagency Policy Coordination
Committee, Office of Science and Technology Policy, Executive Office of
the President, Eisenhower Executive Office Building, 1650 Pennsylvania
Ave., Washington DC 20504, Phone:
[[Page 60415]]
202-456-4444, Online: https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and
SUPPLEMENTARY INFORMATION:
Background Information
In 1986, the Office of Science and Technology Policy (OSTP) issued
the Coordinated Framework for the Regulation of Biotechnology (CF),
which outlined a comprehensive Federal regulatory policy for ensuring
the safety of biotechnology products. The CF sought to achieve a
balance between regulation adequate to ensure the protection of health
and the environment while maintaining sufficient regulatory flexibility
to avoid impeding innovation.
In 1992, OSTP issued an update to the CF that sets forth a risk-
based, scientifically sound basis for the oversight of activities that
introduce biotechnology products into the environment (57 FR 6753;
February 27, 1992) (Ref. 3). The update affirmed that Federal oversight
should focus on the characteristics of the product, the environment
into which it is being introduced, and the intended use of the product,
rather than the process by which the product is created.
On July 2, 2015 the Executive Office of the President (EOP) issued
a memorandum directing the primary Federal agencies that have oversight
responsibilities for the products of biotechnology--the U.S.
Environmental Protection Agency (EPA), the Food and Drug Administration
(FDA), and the U.S. Department of Agriculture (USDA)--to update the CF
to clarify the current roles and responsibilities of the agencies that
regulate the products of biotechnology, develop a long-term strategy to
ensure that the Federal biotechnology regulatory system is prepared for
the future products of biotechnology, and commission an independent,
expert analysis of the future landscape of biotechnology products.
These efforts will build on the regulatory principles described in the
CF and the 1992 update to the CF. The memorandum's objectives are to
ensure public confidence in the regulatory system and to prevent
unnecessary barriers to future innovation and competitiveness by
improving the transparency, coordination, predictability, and
efficiency of the regulation of biotechnology products while continuing
to protect health and the environment.
The July 2, 2015 EOP memorandum stated that the update to the CF
should clarify the current roles and responsibilities of the agencies
that regulate the products of biotechnology by accomplishing the
following four objectives:
(i) Clarifying which biotechnology product areas are within the
authority and responsibility of each agency;
(ii) clarifying the roles that each agency plays for different
product areas, particularly for those product areas that fall within
the responsibility of multiple agencies, and how those roles relate to
each other in the course of a regulatory assessment;
(iii) clarifying a standard mechanism for communication and, as
appropriate, coordination among agencies, while they perform their
respective regulatory functions, and for identifying agency designees
responsible for this coordination function; and
(iv) clarifying the mechanism and timeline for regularly reviewing,
and updating as appropriate, the CF to minimize delays, support
innovation, protect health and the environment and promote the public
trust in the regulatory systems for biotechnology products.
As noted in the July 2, 2015 EOP memorandum, ``biotechnology
products'' refers to products developed through genetic engineering or
the targeted or in vitro manipulation of genetic information of
organisms, including plants, animals, and microbes. It also covers some
of the products produced by such plants, animals, and microbes or their
derived products as determined by existing statutes and regulations.
Products such as human drugs and medical devices are not the focus of
the activities described in the memorandum.
The purpose of this RFI is to solicit relevant data and
information, including case studies, that can inform the development of
the proposed update to the CF and the development of a long-term
strategy consistent with the objectives described in the July 2, 2015
EOP memorandum. In addition to this RFI, the update to the CF will
undergo public comment before it is finalized.
Information Requested
The National Science and Technology Council requests relevant data
and information, including case studies, that can inform the update to
the CF by clarifying the current roles and responsibilities of the EPA,
FDA, and USDA and the development of the long-term strategy consistent
with the objectives described in the July 2, 2015 EOP memorandum. For
details on the current roles and responsibilities of these agencies,
refer to their Web sites.
Relevant FDA Web sites
http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm
Relevant EPA Web sites
http://www.epa.gov/pesticides/biopesticides/regtools/biotech-reg-prod.htm
http://www.epa.gov/biotech_rule/
Relevant USDA Web sites
https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology
A brief summary of these agencies' current roles follows.
The FDA regulates products of genetically engineered (GE) organisms
that fall within FDA's authority under the Federal Food, Drug, and
Cosmetic (FD&C) Act and other statutes. The FDA is responsible for
ensuring the safety of all plant-derived human and animal foods,
including those that are from genetically engineered sources. FDA also
regulates GE animals under the new animal drug provisions of the FD&C
Act, and FDA's regulations for new animal drugs. (The actual regulated
article is the recombinant DNA construct inserted into a specific site
in the genome of an animal; as a shorthand, the FDA refers to the
regulation of GE animals.)
Within USDA, the Animal and Plant Health Inspection Service (APHIS)
is responsible for protecting agriculture from pests and diseases.
Under the Plant Protection Act (PPA) and the Animal Health Protection
Act (AHPA), USDA-APHIS has regulatory oversight over products of modern
biotechnology that could pose a risk to plant and animal health. The
AHPA provides authority to prohibit or restrict imports or entry into
the United States or dissemination of any pest or disease of livestock.
GE animals and insects would be subject to import or transport
restrictions if there is a risk to animal health. The PPA, as amended,
provides authority to regulate the introduction (i.e., importation,
interstate movement, or release into the environment) of certain GE
organisms and products. A GE organism is considered a regulated article
if the donor organism, recipient organism, vector, or vector agent used
in engineering the organism belongs to one of the taxa listed in the
regulation and is also considered a plant pest. A GE organism is also
regulated when APHIS has reason to believe that the GE organism may be
a plant pest. A GE organism is no longer subject to the
[[Page 60416]]
plant pest provisions of the PPA or to regulatory requirements when
APHIS determines that it is unlikely to pose a plant pest risk.
The EPA under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the FD&C Act regulates the sale and distribution of all
pesticides, including those produced through genetic engineering. This
includes microorganisms, biochemicals isolated from organisms, and
plant-incorporated protectants (PIPs), a type of pesticide intended to
be produced and used in living plants. Under the Toxic Substances
Control Act (TSCA), EPA has oversight responsibilities for a wide range
of commercial, industrial, and consumer applications of microbial
biotechnology. New chemicals produced through those microbial
biotechnology applications are subject to premanufacturing review under
TSCA.
Questions
Keeping in mind the principles of the regulation of the products of
biotechnology as articulated in the CF and the 1992 update to the CF,
as well as the objectives of the July 2, 2015 EOP memorandum,
respondents are welcome to address one or more of the following
questions in regards to the proposed update to the CF and the
development of the long-term strategy. Respondents are asked to
indicate to which question responses are targeted.
1. What additional clarification could be provided regarding which
biotechnology product areas are within the statutory authority and
responsibility of each agency?
2. What additional clarification could be provided regarding the
roles that each agency plays for different biotechnology product areas,
particularly for those product areas that fall within the
responsibility of multiple agencies, and how those roles relate to each
other in the course of a regulatory assessment?
3. How can Federal agencies improve their communication to
consumers, industry, and other stakeholders regarding the authorities,
practices, and bases for decision-making used to ensure the safety of
the products of biotechnology?
4. Are there relevant data and information, including case studies,
that can inform the update to the CF or the development of the long-
term strategy regarding how to improve the transparency, coordination,
predictability, and efficiency of the regulatory system for the
products of biotechnology?
5. Are there specific issues that should be addressed in the update
of the CF or in the long-term strategy in order to increase the
transparency, coordination, predictability, and efficiency of the
regulatory system for the products of biotechnology?
References
These references are available electronically at http://www.regulations.gov. We have verified the Web site addresses, but we
are not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.
1. Executive Office of the President. Office of Science and
Technology Policy, Office of Management and Budget, United States
Trade Representative, and Council on Environmental Quality.
Modernizing the Regulatory System for Biotechnology Products, July
2, 2015. Available online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf.
2. Executive Office of the President. Office of Science and
Technology Policy. Coordinated Framework for Regulation of
Biotechnology. 51 FR 23302, June 26, 1986. Available online at:
http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf
3. Executive Office of the President. Office of Science and
Technology Policy. Exercise of Federal Oversight Within Scope of
Statutory Authority: Planned Introductions of Biotechnology Products
Into the Environment. 57 FR 6753, February 27, 1992. Available
online at: https://www.whitehouse.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf
Ted Wackler,
Deputy Chief of Staff and Assistant Director.
[FR Doc. 2015-25325 Filed 10-5-15; 8:45 am]
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