[Federal Register Volume 59, Number 52 (Thursday, March 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6240]
[[Page Unknown]]
[Federal Register: March 17, 1994]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 93-019N]
Update on Livestock and Poultry Connected With Biotechnology
Research
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: This notice (1) reaffirms an earlier policy statement,
published on June 26, 1986, concluding that livestock and poultry
involved in biotechnology experiments are subject to current
regulations relating to eligibility for slaughter at official
establishments, (2) reaffirms an earlier policy statement, published on
December 27, 1991, concluding that livestock and poultry involved in
biotechnology experiments are transgenic research animals and,
therefore, are subject to existing regulations for livestock and
poultry used for research, (3) advises that the Food Safety and
Inspection Service (FSIS) will inspect for human food use livestock and
poultry which were involved in biotechnology experiments, and (4)
announces the availability of a document prepared by FSIS entitled
``Points to Consider for the Evaluation of Transgenic Animals from
Transgenic Animal Research'' (Points to Consider).\1\
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\1\Copies of this document may be obtained from Dr. Pat Basu,
Director, Technology Transfer and Coordination Staff, Science and
Technology, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250; (202) 720-8623.
FOR FURTHER INFORMATION CONTACT:
Dr. Pat Basu, Director, Technology Transfer and Coordination Staff,
Science and Technology, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250; (202) 720-8623.
SUPPLEMENTARY INFORMATION: FSIS is responsible for ensuring the safety,
wholesomeness, and accurate labeling of all meat, meat food products,
and poultry products under the Federal Meat Inspection Act (FMIA), 21
U.S.C. 601 et seq., and the Poultry Products Inspection Act (PPIA), 21
U.S.C. 451 et seq. Livestock and poultry involved in biotechnology
experiments to introduce genetic improvements by transgenesis, i.e.,
transgenic research animals, may be offered for slaughter for food
purposes in official establishments. Agency review and approval in
accordance with 9 CFR 309.17 and 381.75 are required before these
transgenic research animals may be slaughtered for human food use at
official establishments. In addition, persons who intend to slaughter
transgenic research animals or their progeny for human food use at
official establishments may obtain a copy of the Points to Consider
document, and follow the voluntary guidelines set forth in that
document. Persons who follow both the applicable regulations cited
above and the Points to Consider document should note that the
inspector in charge (IIC) may still deny or withdraw the approval to
slaughter transgenic research animals for human food use when the IIC
deems it necessary to assure that products prepared at the official
establishment are not adulterated, in accordance with the FMIA and the
PPIA. The approval to slaughter commercially produced, nonresearch
transgenic animals will be handled separately at a later date.
Currently, trangenesis is usually conducted by injecting
deoxyribonucleic acid (DNA) into fertilized eggs to achieve desired
genetic and/or physical changes. This procedure results in only a small
proportion of animals being born with genetic changes. Animals born
without genetic change may be used for human food under current
policies set forth in the U.S. Department of Agriculture's (USDA's)
June 26, 1986, policy statement published in the Federal Register (51
FR 23336) which states that existing regulations would be applied to
food animals involved in biotechnology experiments. Also, USDA's policy
for the inspection for human food use of livestock and poultry which
are involved in biotechnology research but which are not genetically
modified products of biotechnology, published in the Federal Register
(56 FR 67054) on December 27, 1991, concerns transgenic research
livestock and poultry in which genetic change has not occurred. Due to
the small number of transgenic research animals produced in
biotechnology experiments, such transgenic research animals have not
been presented for slaughter in the past. However, FSIS anticipates
that production of such transgenic animals will increase. This notice
reaffirms USDA's June 26, 1986, and December 27, 1991, notices,
specifically with regard to animals involved in biotechnology
experiments.
Because of the high level of public and Congressional interest in
biotechnology, FSIS is advising in this notice the actions it will take
to ensure that meat, meat food products, and poultry products derived
from livestock and poultry involved in biotechnology experiments are
safe, wholesome, and accurately labeled. This document also provides
guidance to those using biotechnology to produce genetic changes in
livestock and poultry and offering the same for slaughter at official
establishments.
This notice announces the availability of the Points to Consider
document, which discusses FSIS policy for the food safety assessment of
transgenic animals and their progeny and sets forth voluntary
guidelines regarding the presentation of transgenic research animals
and their progeny for slaughter for human food use at official
establishments. For the purpose of this Points to Consider document,
which may be updated as needed, without notice, transgenic animals are
animals whose genetic composition has been changed by introducing
selective genes (e.g., recombinant DNA), whether or not the change
physically manifests itself. This definition includes animals developed
by antisense, amplification, and deletion technologies. Individuals
interested in performing transgenic animal research and presenting such
animals for slaughter may obtain the most recent copy of the Points to
Consider document from the address identified in footnote 1 in this
notice prior to starting his or her research.
Under 9 CFR 309.17 and 9 CFR 381.75, an investigator interested in
presenting transgenic research animals for slaughter should submit data
or a summary evaluation of the data to FSIS. When assessing the human
food safety of meat, meat food products, and poultry products from
transgenic research animals. FSIS may utilize the recommendations
adopted by the Transgenic Animal Working Group of the USDA's
Agricultural Biotechnology Research Advisory Committee. These
recommendations are described in the Points to Consider document.
Upon receipt of all the data or the summary evaluation of data,
FSIS will review and assess the data or summary evaluation of the data.
The data or summary of the data must demonstrate that the research
conducted on the transgenic research animals will not result in the
products of the transgenic research animals or their progeny being
adulterated. Further, the Administrator of FSIS, or the Administrator's
designee, must approve the slaughter of transgenic research animals at
official establishments prior to slaughter. Transgenic research animals
approved for slaughter at an official establishment are subject to the
same inspection procedures as other animals offered for slaughter at
official establishments.
Done at Washington, DC on: March 11, 1994.
Terry L. Medley,
Acting Administrator, Food Safety & Inspection Service.
[FR Doc. 94-6240 Filed 3-16-94; 8:45 am]
BILLING CODE 3410-DM-M
