Attachment II - Page 50 
50904 Federal Register / 
review of food animals resulting from 
the techniques of modem biotechnology 
consists, in general, of two phases. The 
first, an experimental phase, focuses on 
the experimental aspects of vector 
administration, gene transfer and gene 
expression. Since vectors used in animal 
genetic engineering may be considered 
as either animal drugs or animal 
biologies, their administration to food 
animals would be covered under the 
current regulations on experimental 
animals (9 CFR 309.17 and 381.75). The 
requirement that an animal carcass 
intended for use as human food not be 
adulterated may require that certain 
phenotypic and/or biochemical 
parameters not be exceeded before the 
animal can be slaughtered for human 
food. Depending of future developments, 
USDA may amend the research animal 
regulations to provide assurance that 
the products of animals genetically 
engineered by certain techniques are not 
adulterated. The second phase of FSIS's 
regulatory approach, a commercial 
phase, would be carried out under 
existing regulations (9 CFR 301 through 
381) and would be product oriented, 
focusing on commercial development, 
food production. Inspection and 
labeling. 
Additional Considerations 
The manner in which regulations for 
biotechnology are implemented in the 
United States will have a direct impact 
on the competitiveness of U.S. producers 
in both domestic and world markets. 
Inconsistent or duplicative domestic 
regulation will put U.S. producers at a 
competitive disadvantage. Certification 
systems which favor domestic products, 
if adopted by our trading partners, will 
create substantial nontariff barriers to 
trade and block market access. 
Therefore, during the development of the 
U.S. regulatory procedures for 
biotechnology products, attention is 
being paid to the need for achieving 
consistency in national regulation and 
international harmonization. With 
respect to international harmonization, 
the U.S. is seeking to promote sicentific 
cooperation, mutual understanding of 
regulatory approaches and international 
agreement on a range of common 
technical problems such as the 
development of consistent test 
guidelines, laboratory practices and 
principles for assessing potential risks. 
In achieving national consistency and 
international harmonization, regulatory 
decisions can be made in a socially 
responsible manner, protecting human 
health and the environment, while 
allowing U.S. producers to remain 
competitive. 
Vol. 49, No. 252 / Monday, December 31, 1964 / Notices 
Summary 
In summary, USDA anticipates that 
agriculture and forestry products 
developed by modem biotechnology will 
not differ fundamentally from 
conventional products. USDA believes 
that its existing regulatory framework, 
combined with the mandatory NIH 
Guidelines applicable to all research 
grants, is adequate and appropriate for 
regulating research, development, 
testing and evaluation, production, and 
application of these biotechnology 
products. The Department will, 
however, constantly reevaluate its 
regulatory position as the state of the art 
of biotechnology evolves. USDA will use 
a formal and logical process to ensure 
the continual integration of safety 
concepts and other principles for the 
evaluation of biotechnological processes 
and products in agriculture and forestry 
for licensing and granting of permits. 
Should any new processes or products 
be shown to require additional 
regulatory measures, USDA will amend 
its regulations or will request additional 
authority. 
Scientific Advisory Mechanism 
Regulatory decisions must be solidly 
based on the best available science. The 
expansion of commercial applications of 
biotechnology across many fields is a 
direct outgrowth of-a continuously* 
growing science base which draws upon 
the most fundamental understanding of 
molecular biology. Scientific assessment 
of risks associated with biotechnological 
innovation must draw heavily upon that 
sophisticated and changing body of 
knowledge. To supplement agency staff 
in this essential endeavor, the Cabinet 
Council Working Group recommends 
establishment of an independent 
scientific review mechanism, a two- 
tiered advisory structure consisting 
principally of distinguished scientists 
selected by each of five federal 
agencies: EPA, FDA, USDA, NIH, and 
NSF. 
The National Institutes of Health 
Recombinant DNA Advisory Committee 
(RAC), established in 1974, has 
performed well in providing scientific 
assessment of recombinant DNA 
research proposals submitted from 
institutions that receive federal funding 
and has reviewed on a voluntary basis 
experimental protocols submitted by 
industry. The current scientific review 
apparatus is, however, not designed to 
respond to all the scientific issues 
surrounding commercialization of 
biotechnology including the health and 
broad environmental effects of new 
commercial processes and products. 
Hence, the Working Group believes an 
expanded, coordinated scientific 
advisory structure is necessary to meet 
the increased and varied demands for 
scientific evaluation created by the 
needs of modem biotechnology. 
The objectives to be served by the 
proposed scientific advisory mechanism 
are: 
• To provide expert advice on 
scientific issues related to the approval 
of biotechnology products and research 
applications; 
• To provide a coordinating forum for 
addressing scientific problems, sharing 
information, and for consensus building; 
• To promote consistency in the 
development of agencies’ review 
procedures and assessments; 
• To promote continuing cooperation 
among Federal agencies on emerging 
scientific issues; 
• To identify gaps in knowledge. 
To accomplish these goals, a two- 
tiered structure composed of five 
agency-based scientific advisory 
committees under a coordinating parent 
board is proposed. 
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