[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
[Notices]
[Pages 54360-54361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21977]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0188]
RIN 0579-AC37


Genetically Engineered Animals

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Request for information.

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

SUMMARY: The Animal and Plant Health Inspection Service (APHIS) is 
seeking public comment and scientific and technical empirical data and 
information concerning ongoing and future research on genetically 
engineered animals. APHIS' interest is to ensure that genetically 
engineered animals imported into the United States or moved interstate 
do not present risks to U.S. livestock health. We also seek comment on 
what types of actions and approaches APHIS should consider in 
addressing any such risks that would complement the Food and Drug 
Administration's (FDA's) oversight, described in draft guidance 
elsewhere in this issue of the Federal Register.

DATES: We will consider all comments that we receive on or before 
November 18, 2008.

ADDRESSES: You may submit comments by either of the following methods:
    <bullet> Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0188 to submit or view comments and 
to view supporting and related materials available electronically.
    <bullet> Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2006-0188, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2006-0188.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room 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) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Biotechnology Regulatory Services, 
APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; 301-734-
5720.

SUPPLEMENTARY INFORMATION:

Background

    In 1986, the Office of Science and Technology Policy (OSTP) under 
the Executive Office of the President published a policy document known 
as the Coordinated Framework for the Regulation of Biotechnology (the 
Coordinated Framework).\1\ This policy document describes the system 
for coordinating the activities of the Federal agencies responsible for 
regulating all GE organisms:\2\ The Environmental Protection Agency 
(EPA), the U.S. Department of Health and Human Services' (HHS) Food and 
Drug Administration (FDA), and the U.S. Department of Agriculture 
(USDA), specifically the Animal and Plant Health Inspection Service 
(APHIS). The foundation of the Coordinated Framework is that existing 
health and safety laws administered by these Federal agencies provide a 
sound network of agency authorities for the regulation of GE organisms 
and products.
---------------------------------------------------------------------------

    \1\ Coordinated Framework for the Regulation of Biotechnology: 
June 26, 1986; 51 FR 23302; http://usbiotechreg.nbii.gov/CoordinatedFrameworkForRegulationOfBiotechnology1986.pdf.
    \2\ In addition to discussing the regulatory responsibilities of 
these agencies for GE organisms and other products, the Coordinated 
Framework also discusses the responsibilities of agencies with 
jurisdiction over GE research (the National Institutes of Health, 
the National Science Foundation, EPA, and USDA's Agricultural 
Research Service).
---------------------------------------------------------------------------

Roles of APHIS and Other Agencies in the Regulation of GE Animals

    USDA and FDA both have authorities relevant to the oversight of GE 
animals. FDA has authority over new animal drugs under the Federal 
Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 321 et seq.). Elsewhere 
in the issue of the Federal Register, FDA is announcing the 
availability of draft guidance for public comment clarifying its 
oversight of GE animals under the new animal drug provisions of the 
FFDCA. The draft guidance explains that where a recombinant DNA 
construct in a GE animal is intended to affect the structure or 
function of the body of the GE animal, that construct is a new animal 
drug \3\ regardless of the intended use of products that may be 
produced by the GE animal. The FFDCA requires that each new animal drug 
be approved through a new animal drug application (NADA) based on a 
demonstration that it is safe and effective for its intended use. FDA 
has been working with developers of GE animals for almost 20 years and 
the draft guidance is intended to clarify requirements and 
recommendations for producers and developers of GE animals and their 
products.
---------------------------------------------------------------------------

    \3\ In accordance with the definition of ``new animal drug'' in 
21 U.S.C. 321(v).

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

[[Page 54361]]

    The USDA has provided Federal leadership in protecting U.S. 
livestock health for more than 120 years. APHIS is authorized, under 
the Animal Health Protection Act (AHPA) (7 U.S.C. 8301 et seq.), to 
protect the health of U.S. livestock by preventing the introduction and 
spread of livestock diseases and pests into and within the United 
States. Based on that authority, APHIS may broadly consider the 
potential effects of animals with GE traits on the health of the 
overall U.S. livestock population, while FDA is more focused on the 
direct effects of genetic engineering on individual animals based on 
their authority under the FFDCA. Given these complementary authorities, 
APHIS and FDA have been discussing their respective roles in overseeing 
GE animals for some time. FDA's release for public comment of its draft 
guidance on GE animals provides an excellent opportunity for APHIS to 
solicit public comment on the potential effects of animals with GE 
traits on U.S. livestock health.
    APHIS particularly seeks the following information:
    1. What research on GE animals is currently being conducted or 
planned for the future?
    2. What, if any, implications would activities such as the 
importation and interstate movement of such animals have for the health 
of the U.S. livestock population?
    3. What, if any, activities should APHIS consider with respect to 
U.S. livestock health under the AHPA that would complement the 
requirements and recommendations described in FDA's draft guidance?
    APHIS welcomes comments and scientific and technical information 
and data relevant to these issues. We will consider all comments and 
information we receive in determining the appropriate role for APHIS 
with regard to GE animals and will continue to collaborate closely with 
FDA.
    This action has been determined to be significant for the purposes 
of Executive Order 12866 and, therefore, has been reviewed by the 
Office of Management and Budget.

    Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.

    Done in Washington, DC, this 16th day of September 2008.
Bruce Knight,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. E8-21977 Filed 9-18-08; 8:45 am]
BILLING CODE 3410-34-P