[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Notices]
[Page 54360-54361]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se08-24]
-----------------------------------------------------------------------
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Administration's (FDA's) oversight, described in draft guidance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:
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.
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