Attachment II - Page 3 
Federal Register / 
and the Environment The fundamental 
purpose of the Working Group is to 
insure that the regulatory process 
adequately considers health and 
environmental safety consequences of 
the products and processes of the new 
biotechnology as they move from the 
research laboratory to the marketplace. 
The Working Group recognises the need 
for a coordinated and sensible 
regulatory review process that will 
minimize the uncertainties and 
inefficiencies that can stifle innovation 
and impair the competitiveness of U.S. 
industry. It recognizes that not only 
should approaches be consistent from 
agency to agency end within each 
agency from application to application, 
but also that regulatory decisions should 
be based upon the best available 
science. 
The importance of addressing the 
emerging commercial aspects of 
biotechnology in a coordinated and 
timely fashion is captured in the recent 
report by the Congressional Office of 
Technology Assessment which warned: 
“Although the United States is currently 
the world leader in both basic science 
and commercial development of new 
biotechnology, continuation of the initial 
preeminence of American companies in 
the commercialization of new 
biotechnology is not assured.” 1 
The Working Group recognizes that 
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 and 
the future development of basic science. 
Thus, the Working Group has 
endeavored to develop a coherent and 
sensible regulatory process, one based 
on the best available scientific facts and 
intended to minimize uncertainties, 
delays, overlaps, and inconsistencies. 
Attention will be paid also to 
international harmonization. The United 
States is seeking to promote scientific 
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. 
The U.S. also is committed to reducing 
barriers to trade in biotechnology. U.S. 
regulatory agencies will provide similar 
treatment to domestic and foreign 
products with regard to their regulations 
and approval procedures. Barriers to 
trade of biotechnology products can 
only be avoided if the U.S. and other 
1 Commercial Biotechnology, “An International 
Analysis," Office of Technology Assessment, Pg. III.. 
19S4. 
VoL 49, No. 252 / Monday, December 31, 1984 / Notices 50857 
nations join together in working toward 
this goal. In achieving national 
consistency and international 
harmonization, regulatory decisions can 
be made in a socially responsible 
manner, protecting human health and 
the environment, allowing U.S. 
producers to remain competitive and, 
most importantly, assuring that 
everyone will reap the benefits of this 
exciting biological revolution. 
Regulation of Biotechnology Processes 
and Products 
In response to concerns of the 
scientific community in the early 1970s, 
the Federal Government sponsored a 
conference to explore the risks and 
benefits of recombinant DNA {rDNA) 
research. In 1974 the National Institutes 
of Health (NIH) chartered the 
Recombinant DNA Advisory Committee 
(RAC) to provide scientific advice and 
in 1976 developed the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules. It was reasoned that a 
cautious approach to this research was 
essential to assure safety while still 
fostering the advancement of this new 
technology. These guidelines have 
allowed research to flourish within 
appropriate constraints. Experience 
gained in rDNA laboratory research has 
mitigated many of the concerns about 
risk, thus allowing modification of the 
original guidelines and oversight 
mechanisms. 
Almost a decade later as the pace of 
commercial application has accelerated, 
this new initiative was undertaken to 
review' regulatory requirements and to 
articulate policy for biotechnology 
products. In April 1984, the Cabinet 
Council on Natural Resources and the 
Environment established en interagency 
working group to study and coordinate 
the government’s regulatory policy for 
these products. 2 The group was asked 
to: 
1. Review the regulatory requirements 
which have been applied to 
commercialized biotechnologies. 
2. Identify existing laws and 
regulations that may be applicable to 
biotechnology. 
3. Review the function of the NIH 
Recombinant DNA Advisory Committee 
and its role in biotechnology 
commercialization and safety regulation. 
* The member agencies Include: Departments of 
Interior, Justice, Slate, Agriculture, Commerce, 
Defense, Energy. Health and Human Services, and 
Labor Environmental Protection Agency: Council 
on Environmental Quality: Council of Economic 
Advisors: Office of Management and Budget; Office 
of Policy Development; the National Science 
Foundation; Office of the U.S. Trade Representative; 
and Ihe Office of Science and Technology Policy. 
4. Clarify the regulatory path that a 
company with a new product would 
follow to meet Federal health and safety 
requirements. 
5. Determine whether current 
regulatory requirements and Federal 
review are adequate for new products. 
6. Develop specific recommendations 
for administrative or legislative actions 
to provide additional regulatory review 
if warranted, while maintaining 
flexibility to accommodate new 
developments. 
7. Review court rulings regarding the 
granting of patents for biotechnology. 
8. Review other Federal actions such 
as support of basic research and 
training, US. patents and trade laws, 
and other policy issues which affects 
commercialization and U.S. competitive 
position vis-a-vis international firms. 
The results of the interagency effort to 
date are reflected in the publication of 
this notice for public review and 
comment. These include: (1) Regulatory 
matrix: a concise index of the current 
regulatory requirements that might be 
applicable to biotechnology, (2) Policy 
statements: a compilation of proposed 
statements of policy that describe how 
the U.S. Department of Agriculture, the 
Environmental Protection Agency and 
the Food and Drug Administration 
intend to apply their existing regulatory 
authorities to biotechnology products; 
(3) A Scientific Advisory Mechanism: a 
coordinated structure of scientific 
review to promote consistent risk 
assessment within statutory confines: 
and (4) Glossary: a glossary of terms 
used in the policy statements. 
Given the evolving nature of 
biotechnology, the Working Group will 
continue to meet to review the ongoing 
process- If regulatory gaps emerge and 
the process is not responding to public 
concerns, the Working Group will make 
recommendations for either 
administrative reform or additional 
legislative authority. 
1. Regulatory Matrix 
The matrix outlines laws, regulations 
and guidelines that may be applicable to 
biotechnology products at some point in 
research, development, marketing, 
shipment, use, or disposal. To aid in 
understanding current requirements, the 
matrix has been divided into seven 
parts which have been cross-referenced 
when necessary: 
I. Licensing and other premarketing 
requirements; 
II. Post-marketing requirements: 
III. Export controls: 
IV. Research and information 
gathering: 
V. Patents: 
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