Attachment II - Page 4 
50858 Federal Register / 
VI. Air and water emissions 
standards; and 
VII. Requirements for Federal 
agencies. 
The matrix will be reviewed annually 
and updated as necessary. 
2. Policy Statements 
Individual “Statements of Proposed 
Policy" have been developed by the 
three regulatory agencies — FDA, USDA 
and EPA — that will be involved most 
extensively in oversight of research and 
industrial engaged in product 
development. These statements do not 
describe detailed regulatory 
requirements, but rather the general 
policy framework within which 
regulatory decisions will be made. They 
attempt to provide a clear understanding 
of how regulatory agencies will 
approach this evolving technology. At 
present the regulatory authorities that 
are in place appear to accommodate 
these new products. 
The responsibilities of EPA, FDA and 
USDA are determined by statute (see 
the Matrix of Federal Authorities 
elsewhere in this notice), and are 
generally based upon key 
characteristics or uses of the end 
products. When new types of products 
are developed, such as will be the case 
with biotechnology, each agency must 
develop and apply certain rules for 
determining whether its statutes apply 
with possible modification of existing 
rules. For example, FDA must determine 
whether products containing genetically 
engineering microorganisms constitute 
food additives, drugs, or other products 
subject to FDA approval, EPA whether 
they are pesticides or industrial 
products, and USDA whether they are 
plant pests, animals biologicals, or other 
agricultural products subject to its 
authority. These decisions must be 
consistent with the statutory 
requirements of the laws each agency 
administers. 
Regardless of the criteria used to 
determine whether a product is within 
the responsibility of a given agency, all 
three agencies will approach the review 
of biotechnology products and processes 
in similar ways. All conduct their 
assessments on a case-by-case basis. 
Vol. 49, No. 252 / Monday, December 
employing internal staff, consultants, 
and expert advisory committees 
(described below). Each considers the 
ultimate safety of the product as a 
primary concern; other issues, such as 
efficacy, may also be considered. Also, 
each agency develops product review 
criteria and procedures which are 
consistent with its historical experience 
and scientific data bases developed 
from reviewing other products with 
similar uses. 
EPA, FDA and USDA are committed 
to working together and with other 
members of the Cabinet Council 
Working Group to coordinate and 
improve the development of appropriate 
and useful scientific evaluation methods 
and administrative procedures for 
genetically engineered organisms and 
their products. All are striving for a 
balanced approach supported by sound 
science and incorporating the latest 
scientific and technological information. 
The statements of proposed policy 
which each has prepared and which are 
issued in this notice are viewed as 
among the first steps toward that goal. 
3. Scientific Advisory Mechanism 
The importance of the highest caliber 
scientific advice to the decision-making 
process for oversight of biotechnology is 
undisputed. NIH’s experience with its 
RAC is an example of the value-of using 
distinguished scientists to participate in 
the assessment of risk of new projects or 
proposals involving genetic 
manipulation. The experience of the 
RAC over the past ten years serves as a 
valuable model to the Working Group in 
structuring the proposed scientific 
review coordinating mechanism. 
With the evolution of biotechnology 
and its increasing commercialization, 
the complexity and scope of scientific 
review broadens and the existing 
mechanisms for scientific review must 
be expanded. The Working Group 
proposes an adjunctive scientific 
advisory mechanism that will 
accommodate the needs of individual 
agencies and provide a central focus for 
scientific advice on biotechnology 
issues. It affords maximal opportunity to 
achieve scientific consensus and retains 
the flexibility in scientific policy 
guidance that has characterized the 
31, 1984 / Notices 
existing NIH RAC. In addition, it can *■*» 
implemented in a short time. 
4. Glossary 
The glossary included at the end of 
this notice is intended to provide 
definitions for terms appearing in the 
policy statements to assist the reader in 
reviewing the notice. The definitions are 
not to be considered legally binding on 
any Federal agency and may be revise' 
as needed. 
Interagency Coordination of Risk 
Management and Regulation in 
Biotechnology 
In addition to coordination of 
scientific review, the Working Group 
recognizes the need for coordination of 
the regulatory activities of the federal 
government. An interagency committee 
is needed to foster timely and 
coordinated decision making via 
interagency communication on matters 
of regulation; discuss matters of 
jurisdiction among agencies; serve as a 
mechanism by which agencies can raise 
public and concerns; and consider 
generic approaches for translating risk 
industry assessment information into 
policy decisions. 
The Cabinet Council Working Group 
also recognizes the need for this 
continuing coordinated mechanism also 
to address the broader issues within the 
regulatory process itself. Although at the 
present time existing statutes seem 
adequate to deal with the emerging 
processes and products of modem 
biotechnology, there are always 
potential problems and deficiencies in 
the regulatory apparatus in a fast 
moving field. We believe this 
interagency coordinating committee 
should monitor the changing scene of 
biotechnology and serve as a means of 
identifying potential gaps in regulation 
in a timely fashion, making appropriate 
recommendations for either 
administrative or legislative action. 
For the time being the Cabinet Council 
Working Group can serve these needs. 
When its activities are concluded, an 
interagency coordinating committee for 
Biotechnology would, if still needed, be 
established to continue this effort. 
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