Attachment II - Page 27 
Federal Register / 
Comments received on ths notice, 
except those containing confidential 
business information, will be available 
for review and copying from 8 a.m. to 4 
p.m. Monday through Friday, except 
legal holidays, in the TSCA Public 
Information Office, Rm. E-107 at the 
address given above. 
FOR FURTHER INFORMATION CONTACT: 
For general information including copies 
of the following EPA portion of this 
notice and related materials: Edward A. 
Klein, Director, TSCA Assistance Office 
(TS-799), Office of Toxic Substances, 
Environmental Protection Agency, Rm. 
E-543, 401 M St., SW., Washington, D.C. 
20460, Toll-free: (800-424-0065), In 
Washington, D.C.: (202-554-1404, 
Outside the USA: (Opera tor-202-554— 
1404). 
For technical information regarding 
the FIFRA sections of the EPA proposed 
policy: Frederick S. Betz, Hazard 
Evaluation Division (TS-769c), Office of 
Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., 
Washington, D.C. 20460. Office location 
and telephone number: Rm. 1123, Crystal 
Mall #2, 1921 Jefferson Davis Highway, 
Arlington. VA 22202, (703-557-9307). 
For technical information regarding 
the FIFRA sections of the EPA proposed 
policy: Anne K. Hollander, Office of 
Toxic Substances (TS-794), 
Environmental Protection Agency, Rm. 
E-511, 401 M St., SW., Washington, D.C 
20460, (202-382-3852). 
Index 
Following is an index to the EPA portion of 
this notice: 
I. Introdution. 
A. Scope of this Notice 
B. Common Issues under FIFRA and TSCA 
1. Risk assessment information needs 
2. Direct release of microorganisms to the 
environment 
3. Plants and animals 
4 . Coordination with other Federul agencies 
5. Need for balanced approach among safety, 
regulation, and innovation 
II. Applicability of FIFRA to Nonindigenous 
and Genetically Engineered Microbial 
Products. 
A. General Scope of FIFRA 
B. Scope of this Unit 
C. Background/History 
1. Past activities related to microbial 
pesticides 
2. Concerns related to microbial pesticides 
D. Current Regulatory Status of Microbial 
Pesticides 
E. Plan for Reviewing and Registering 
Nonindigenous and Genetically 
Engineered Microbial Pesticides Under 
FIFRA 
1. Proposed plan 
2. Long term strategy under FIFRA.f 
F. Small-Scale Field Testing 
1. Background Information on the 
Nonindigenous or Genetically 
Engineered Microorganisms 
Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 50881 
2. Description of Proposed Test 
III. Applicability of TSCA to products of 
Biotechnology. 
A. General Scope of TSCA 
1. Applicability to living organisms 
2. General types of products subject to TSCA 
3. Plants and animals 
B. Premanufacture Notice Requirements 
1. Description of authority 
2. Applicability of PMN requirements to 
certain products of biotechnology 
a. Summary of applicability 
b. “New" v. "naturally occuring” substances 
c. Discussion of specific processes 
3. Chemical substances produced by 
genetically engineered organisms 
4 . Research and development exemption 
5. Other TSCA PMN exemptions 
C. Significant New Use Authority 
D. Implementation Issues 
1. PMN requirements 
a. Effective date 
b. Status of substances now in commerce 
c. PMN rules and form 
2. Applicability to isolated nucleic acid 
fragments 
3. Confidentiality 
4 . Inventory and nomenclature issues 
5. Issues related to other TSCA authorities 
a. Section 8(c) 
b. Section 8(e) 
c. Section 13 
E. Nature of EPA’s PMN Review 
1. Authority to obtain Information 
2. Types of information required 
3. Conduct of review 
IV. Intra-agency, Interagency, and 
International Activities. 
A. Coordination within EPA 
B. Interagency Coordination 
C. International Activities 
V. References. 
VI. Public Record. 
I. Introduction 
A. Scope of This Notice 
The Federal Insecticide, Fungicide, 
and Rodenticide Act provides EPA 
authority over pesticidal products, 
including the authority to review and 
register new pesticides: the Toxic 
Substances Control Act provides EPA 
authority over non-pesticidal, non-food, 
and non-drug products, and requires 
EPA to review "new chemical 
substances" before commercial 
manufacture. These statutes will apply 
to certain commercial products of 
biotechnology, just as they already 
apply to chemical and biological 
products developed by more 
conventional methods. 
This notice describes how EPA plans 
to address certain microbial products 
under FIFRA and TSCA. It explains the 
scope of coverage and procedures for 
review under both statutes, and it 
highlights the similarities and 
differences between treatment or 
nonindigenous and genetically 
engineered microbial substances and 
other substances. In doing so, the 
following questions are addressed: 
1. Which products of biotechnology 
may be subject to review under FIFRA 
or TSCA? 
2. How does the Office of Pesticides 
and Toxic Substances (OPTS) propose 
to use its authority under FIFRA and 
TSCA to review products of 
biotechnology? 
3. Should the procedures used under 
FIFRA and TSCA to review 
conventional products be changed in the 
review of nonindigenous and genetically 
engineered microbial products used for 
environmental and consumer 
applications? 
4. What data requirements should be 
applied to microbial products under 
FIFRA and TSCA? 
This notice primarily addresses 
microorganisms used as commercial 
products, emphasizing those areas in 
which EPA believes its oversight will 
contribute most to human or 
environmental safety, and where the 
application of FIFRA and TSCA are 
most appropriate. Chemical products 
derived from microbes, plants and 
animals will also be discussed briefly in 
the respective units pertaining to FIFTIA 
and TSCA. 
Although the microorganisms 
discussed in this notice include 
naturally occurring, indigenous microbes 
as well as nonindigenous and 
genetically engineered microbes, 
emphasis has been placed on the latter 
groups. "Nonindigenous" or “exotic” 
microbes are natually occurring 
microorganisms placed in environments 
where they are not native. "Genetically 
engineered” organisms are defined in 
the glossary to this notice. 
In the approach discussed in this 
notice, nonindigenous and genetically 
engineered microbial pesticides may, on 
a case-by-case basis, be subject to 
greater data requirements under FIFRA 
than other microbial pesticides. 
Genetically engineered microorganisms 
used for non-drug, non-food, or non- 
pesticidal purposes (such as pollution 
control or enhanced oil recovery) would 
be subject to premanufacture review 
under TSCA. 
Proposed approaches under FIFRA 
and TSCA are discussed in detail in 
Units LI and III of this notice. Unit IV 
identifies intra-agency, interagency, and 
international activities, and references 
are found in Unit V. 
D. Common Issues Under FIFRA and 
TSCA 
FIFRA and TSCA provide authority to 
review certain products of 
biotechnology before commercial 
manufacture, including microbial 
products used in environmental and 
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