Attachment II - Page 2 
50856 Federal Register / Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 
OFFICE OF SCIENCE AND 
TECHNOLOGY POLICY 
Proposal for a Coordinated 
Framework for Regulation of 
Biotechnology 
AGENCY: Executive Office of the 
President, Office of Science and 
Technology Policy. 
action: Notice for public comment. 
summary: The purpose of this Federal 
Register notice is to provide a concise 
index of U.S. laws Telated to 
biotechnology, to clarify the policies of 
the major regulatory agencies that will 
be involved in reviewing research and 
products of biotechnology, to describe a 
scientific advisory mechanism for 
assessment of biotechnology issues, and 
to explain how the activities of the 
Federal agencies in biotechnology will 
be coordinated. 
date: Comments must be received on or 
before April 1, 1985. 
Public Participation: The Cabinet 
Council Working Group on 
Biotechnology through the Office of 
Science and Technology Policy, is 
seeking the advice of individuals, public 
interest groups, industry and academia 
on all aspects of this publication. The 
Working Group welcomes candid 
assessments of the process and the 
policy as well as questions raised 
regarding the scope of the proposal. 
The intention of the Working Group is 
to republish this material in final form 
as soon as possible following the close 
of the comment period. This will assure 
that well understood regulatory policy 
and process are established in timely 
manner to enable a beneficial industry 
to proceed safely and efficiently. 
Information submitted as comments to 
EPA on this notice may be claimed 
confidential by marking any part or all 
of that information as “Confidential 
Business Information." Information so 
marked will not be disclosed except in 
accordance with procedures set forth in 
40 CFR Part 2. A sanitized copy of any 
material containing Confidential 
Business Information must be provided 
to EPA by the submitter for inclusion in 
the public record. Information not 
marked confidential may be disclosed 
publicly by EPA without prior notice. 
ADDRESS: Comments specific to the 
EPA, USDA, or FDA policy statements 
should be addressed to: 
EPA: Docket #OPTS 00049, Document 
Control Officer (TS-793), Office of 
Toxic Substances, Environmental 
Protection Agency, Room E-409, 401 
M Street, SW„ Washington, D.C. 
20460 
USDA: Docket # APHIS 00049, Ms. 
Karen Darling, Deputy Assistant 
Secretary, Marketing and Inspection 
Services, U.S. Department of 
Agriculture, Room 242-E, 
Administration Building, 12th and 
Independence Avenue, SW„ 
Washington, D.C. 20250 
FDA: Docket #84N-0431, Dockets 
Management Branch, Food and Drug 
Administration (HFA-305), Room 4- 
62, 5600 Fishers Lane. Rockville, MD 
20857 
Any other comments should be 
provided to the following address: Dr. 
Bemadine Healy Bulkley, Deputy 
Director, Office of Science and 
Technology Policy, Executive Office of 
the President, NEOB — Room 5005. 
Washington, D.C. 20506. 
Jerry D. Jennings, 
Executive Director, Office of Science and 
Technology Policy. 
December 21, 1984. 
Table of Contents 
I. Introduction 
II. Regulatory Matrix 
III. Statements of Proposed Policy 
A. Food and Drug Administration’s Policy 
for Regulating Biotechnology 
B. Environmental Protection Agency 
Statement of Policy Regarding Certain 
Microbial Products 
C. Statement of U.S. Department of 
Agriculture Policy for Regulating 
Biotechnology Processes and Products 
IV. Scientific Advisory Mechanism 
V. Glossary 
Introduction 
Only forty years ago, DNA was 
discovered to be the repository of 
genetic information. This discovery has 
been followed by an explosion in our 
understanding and ability to manipulate 
the gene as manifest by the new 
commercial biotechnology which has 
introduced a new and profound 
dimension into the field of classical 
genetics. Today, new techniques for 
manipulating genetic information offer 
exciting advances, as remarkable as the 
discovery of antibiotics or the computer 
chip. 
While some techniques of 
biotechnology are not new — the use of 
yeast in baking and brewing began 
around 6000 B.C. — the most recently 
developed techniques are far more 
sophisticated. Modern biotechnology 
promises to benefit many fields of 
human endeavor by offering new 
services and a wide variety of products 
superior to those currently available 
because they will be more effective, 
convenient, safer, or more economical. 
Biotechnology already has successfully 
produced new drugs and improved 
existing drugs such as human insulin. 
interferons and vaccines. Exciting 
research is underway in agricultural 
applications to enhance plant and 
animal productivity to help feed the 
world's people. Within reach of 
commercial applicability are products to 
diagnose, prevent and treat animal 
diseases, to improve animal breeds and 
to improve specific plant characteristics. 
Microorganisms have also been 
developed in research laboratories to 
degrade pollutants, enhance oil 
recovery, convert biomass to energy, 
leach minerals, and concentrate metals. 
With this diversity of applications, 
biotechnology will alleviate many 
problems of disease and pollution and 
increase the supply of food, energy, and 
raw materials. 
The United States is now the world 
leader in biotechnology. This leadership 
is derived from a strong science base, a 
vigorous entrepreneurial spirit and 
availability of venture capital. New uses 
of biotechnology have created intense 
domestic and international competition. 
Several other nations have elevated the 
development of biotechnology to a 
national priority. The tremendous 
potential of biotechnology to contribute 
to the nation’s economy in the near 
term, and to fulfill society's needs and 
alleviate its problems in the longer term, 
makes it imperative that progress in 
biotechnology be encouraged. 
While the potential benefits of 
biotechnology are widely 
acknowledged, legitimate concerns 
about safety have also been raised as 
additional products of biotechnology 
move from contained research 
laboratories into full contact with the 
public and the environment through 
commercial testing and applications in 
the environment. For example, concerns 
have been raised about the effect of 
genetic manipulations on the potential 
virulence of altered microorganisms, or 
the ability of new organisms tombtain a 
selective advantage. Certainly both the 
safety and effectiveness of new 
processes and products must be central 
issues in the design of new scientific 
developments or technological 
innovations. Accordingly, it is 
incumbent upon the government, the 
business community, and the public to 
take responsible and timely measures to 
insure that the public health and the 
environment are protected and that 
societal concerns are promptly 
addressed. 
The Administration, recognizing its 
responsibility to confront the special 
concerns that surround modem 
biotechnology .'formed an interagency 
working group under the White House 
Cabinet Council on Natural Resources 
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