80 FR 60414 - 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

SCIENCE AND TECHNOLOGY POLICY OFFICE

Federal Register Volume 80, Issue 193 (October 6, 2015)

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.

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60414-60416]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25325]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
 BILLING CODE 3270-F5-P