Attachment II - Page 41 
Federal Register / Vol. 49, No. 252 / Monday, December 31. 1984 / Notices 50895 
purposes might be applicable to later 
uses of the organism for TSCA 
purposes). 
3. Conduct of review. The Agency 
recognizes the complex issues 
associated with the review of 
genetically engineered microorganisms, 
particularly when released to the 
environment. Because of the absence of 
formalized risk assessment 
methodologies and the limited data base 
in this area, expert judgment is critical 
in determining information needs and 
reviewing potential risks. The review of 
such organisms may require expertise in 
such areas as microbial, plant, and 
animal ecology and pathology; human 
health and environmental risk 
assessment of living organisms; and 
molecular and microbial genetics. 
Because of the range of expertise that 
may be required in any given case, OTS 
intends to supplement its expertise by 
drawing from other offices within EPA 
in the review of new microorganisms 
and to use expert consultants from other 
Government agencies and academia, 
where appropriate. The Agency also 
plans to rely on the federal 
Biotechnology Advisory Board and an 
EPA biotechnology advisory committee 
to provide expert advice and promote 
consistent review procedures. The 
details of this proposed advisory system 
are described in the preface to this FR 
notice. 
Because of the complexity of review 
issues, and the limited length of the 
PMN review period, OTS will encourage 
persons to consult with it before 
submitting a PMN on a new 
microorganism. OTS routinely offers 
manufacturers the opportunity for 
prenotice consultation concerning PMN 
submissions; this would be particularly 
important for biotechnology. During the 
period of prenotice consultation, OTS 
would be able to provide guidance on 
appropriate levels of information for a 
notice, and manufacturers would be 
able to describe the specifics of their 
situation. 
Within 5 days of receipt of a notice, 
OTS will, in accordance with section 
5(d)(2), issue a notice in the Federal 
Register stating the identity of the new 
chemical substance, the category of use, 
a summary of test data submitted in the 
notice, and the submitter’s identity. 
When information is claimed 
confidential, it will be shielded by a 
generic description. In addition, OTS 
will maintain a sanitized copy of the 
PMN in the OTS Public Information 
Office, at the address listed at the end of 
this notice. OTS will welcome comments 
from interested members of the public 
on the PMN. The public is generally 
given 30 days to comment on a PMN 
after publication of the section 5(d)(2) 
notice. 
IV. Intra- Agency, Interagency, and 
International Activities 
A. Coordination Within EPA 
Several EPA program offices in 
addition to OPTS have authority 
relevant to biotechnology (see the 
regulatory matrix elsewhere in this 
notice). The Office of Solid Waste and 
Emergency Response (OSWER), for 
example, will be responsible for 
regulating solid waste produced by 
companies using biotechnology and is 
exploring a variety of approaches for 
using genetically engineered 
microorganisms to degrade pollutants. 
The Office of Water has similar 
responsibility for process effluents, 
water pollution control, and other water- 
quality issues. In addition, since 1977 
ORD has supported research in the use 
of engineered organisms to degrade 
pollutants and in the development of 
testing protocols for microbial 
pesticides. This research has formed the 
basis of OPP’s testing guidelines for 
microbials, described in Unit II of this 
notice. Over the next several years. 
ORD will be increasing its research 
support to the program offices. A 
description of ORD’s research agenda in 
biotechnology is available as a support 
document to this notice. 
EPA is taking steps to ensure that the 
biotechnology activities of its program 
offices are coordinated and the 
expertise in each of the offices is shared. 
To achieve this end, EPA has organized 
an Agency-wide biotechnology 
committee, made up of senior staff from 
its various offices. This group will 
provide policy and scientific support to 
the different program offices. The panel 
will provide a mechanism for securing 
Agency experts for the review of 
nonindigenous and genetically 
engineered microorganisms and of 
technical documents prepared by the 
program offices. 
B. Interagency Coordination 
A number of other Federal agencies 
besides EPA have direct interest in the 
promotion or oversight of biotechnology. 
NIH, FDA, USDA, and OSHA have 
review and regulatory authorities over 
biotechnology. (USDA in fact has 
statutes which apply to some of the 
same organisms EPA regulates, as 
described in Unit I.B.4). In addition, 
NIH, USDA, the National Science 
Foundation, the Department of Defense, 
and the Department of Energy, among 
other agencies, have committed 
significant resources to biotechnology 
research. The Commerce Department — 
particularly through the Patent Office, 
the International Trade Administration, 
and the National Bureau of Standards — 
has a major interest in economic and 
trade aspects of the biotechnology 
industry. The State Department has also 
been involved in international policy, 
scientific, and trade issues. EPA will be 
cooperating with these agencies as they 
implement their respective mandates. 
EPA's particular concern for 
interagency coordination lies in the area 
of health and environmental risks. EPA 
representatives from ORD and OPTS 
serve as nonvoting liaison to the NIH 
RAC; EPA's biotechnology committee 
described above will be able to provide 
guidance to the Agency's RAC 
representatives on specific 
environmental issues under review by 
that committee. More broadly, EPA is 
participating with other Federal 
agencies in a review by the Cabinet 
Council on Natural Resources and the 
Environment on Federal procedures and 
regulations related to biotechnology. In 
addition, EPA is working with other 
agencies to address such issues as 
mechanisms for sharing Federal 
expertise and coordinating research and 
consistency of risk assessment methods 
and philosophies in the different 
agencies. 
C. International Activities 
Biotechnology raises issues of 
international as well as domestic 
coordination. Most of the U.S.' major 
trading partners, including the European 
Economic Community nations and 
Japan, are promoting the 
commercialization of genetic 
engineering techniques and are 
reviewing possible regulatory 
approaches. Because risks from 
organisms introduced into the 
environment may be international in 
scope, and because 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, 
international cooperation is essential. 
Inconsistent or duplicative domestic 
regulation will put U.S. producers at a 
competitive disadvantage. In addition, 
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 will be paid to the need for 
achieving consistency in national 
regulation and international 
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