Attachment II - Page 28 
50882 Federal Register / Vol. 49. No. 252 / Monday, December 31, 1984 / Notices 
consumer applications. These two 
statutes, both of which ere administered 
by EPA through OPTS, have numerous 
similarities, even though they entail 
different responsibilities and apply to 
different classes of products. One goal 
of the two OPTS offices responsible for 
administering these statutes — the Office 
of Pesticide Programs (OPP) and the 
Office of Toxic Substances (OTS) — is to 
develop a consistent program within the 
constraints of the two statutes. 
In developing this program. OPP and 
OTS are addressing a number of 
common issues. These issues are 
identified here and discussed more fully 
in Subsequent units of this notice. 
1. Risk assessment information needs. 
A major common issue is the need to 
determine what information is 
necessary for assessing the risks posed 
by nonindigenous and genetically 
engineered microorganisms. Although 
OPP has experience with regulating 
naturally occurring microbial pesticides, 
there is concern about potential human 
or environmental risks specific to 
nonindigenous and engineered 
microbes. As a result, the type and 
amount of information needed to assess 
any special risks of these microbial 
products will be determined on a case- 
by-case basis, as discussed in Units II. F 
and III.E. 
(2) Direct release of microorganisms 
to the environment. A second common 
issue is at what stage EPA should 
review certain microbial products before 
any direct release to the environment, 
such as small-scale field testing. The 
Agency believes that review of small- 
scale field testing of nonindigenous and 
genetically engineered products is 
necessary in order to provide adequate 
protection to human health and the 
environment. Comments are requested 
on this issue, which is discussed in Units 
II. F and HI.B.5. 
3. Plants and animals. A third 
common issue is whether it is necessary 
or appropriate for OPTS to address 
genetically engineered plants and 
animals. Currently, OPP has exempted 
plants and animals used as pesticides 
from review under FIFRA because they 
are addressed by other Federal 
agencies. EPA also believes that other 
statutes and regulations are likely to be 
more appropriate for regulating 
engineered plants and animals used for 
purposes potentially subject to TSCA 
(e.g., production of fiber or lumber). 
Therefore, EPA docs not propose that 
plants and animals be subject to TSCA 
review. This issue is discussed in Units 
II. D and III.A.3 of the notice. 
4. Coordination with other Federal 
agencies. A fourth common goal of OTS 
and OPP i." *o coordinate with other 
Federal agencies with interests in 
biotechnology, including the U.S. 
Department of Agriculture (USDA), the 
Occupational Health and Safety 
Administration (OSHA), the Department 
of Health and Human Services (HHS), 
the Department of Commerce, and 
others. Such coordination can eliminate 
regulatory overlaps, achieve a clear 
delineation of each agency’s 
responsibility, and insure a consistent 
Federal approach in coordinating 
Federal research sharing information on 
risk assessment methods for products of 
biotechnology. 
Coordination with the USDA is 
particularly important to the EPA 
because USDA has jurisdiction over 
some of the same organisms which EPA 
regulates. The fact that a plant- 
associated microorganism may be 
subject to an EPA law does not exempt 
it from any applicable statutes 
administered by the USDA. For 
example, ah microbes which are plant 
pathogens are subject to the USDA Plant 
Pest Act, and all microbes ased as 
pesticides are subject to FIFRA. 
Therefore if a microbe is a plant 
pathogen and a pesticide, it is subject to 
both USDA and EPA laws. Similarly, 
microbes which are sold ia Conjunction 
with seeds fall under various seed 
certification programs, even though they 
may also be subject to FIFRA or TSCA 
because of their intended uses. 
EPA and USDA will work 
cooperatively and simultaneously in the 
evaluation of genetically engineered 
products which fall under the 
jurisdiction of both agencies. For further 
information on the applicable 
authorities of EPA and USDA, refer to 
the EPA policy statements on TSCA and 
FIFRA, and to the USDA Statement of 
Policy elsewhere in this notice. 
Interagency coordination is discussed 
further in Unit IY..IL 
5. Need far a balanced approach 
among safety* regulation. and 
innovation. The potential benefits of 
biotechnology are enormous, both to 
consumers who will enjoy new, 
enhanced, or less expensive products, 
and to the economy as a whole. Despite 
this potential, biotechnology is still in its 
commercial infancy, and innovation and 
commercial development in the field is 
extremely sensitive to regulatory 
uncertainty. 
Both FIFRA and TSCA are risk- 
balancing statutes, drafted by the 
Congress to require a balance between 
the restrictions and higher costs created 
by a regulation and the lower risks to 
public health and the environment. 
Under both statutes, therefore, EPA 
plans to develop a policy for 
biotechnology that addresses this 
balance, is supported by sound science, 
and incorporates new information as it 
becomes available. 
II. Applicability of FIFRA To 
Nonindigenous and Genetically 
Engineered Microbial Products 
A. General Scope of FIFRA 
FIFRA establishes the Agency’s 
authority over the distribution and use 
of pesticide products. Before the Agency 
can register a pesticide, FIFRA requires 
the Agency to have sufficient data to 
determine that the pesticide, when used 
in accordance with widespread and 
commonly recognized practice, will not 
cause (or significantly increase the risk 
of) unreasonable adverse effects to 
humans or the environment (see section 
3(c)(5) and (7) of FIFRA). Such data are 
also specifically required in the 
regulations promulgated pursuant to 
FIFRA at 40 CFR 162.8 and 162.18-2. 
The Agency has issued a final 
regulation, 40 CFR Part 158, published in 
the Federal Register of October 24, 1984 
(40 CFR 42856), specifying the kinds of 
data and information that must be 
submitted to EPA to support the 
registration of each pesticide under 
FIFRA. The Agency has also published 
the Pesticide Assessment Guidelines for 
microbial pesticides. This is an advisory 
document which is available through the 
National Technical Information Service 
(NTIS). The guidelines specify the 
standards for conducting acceptable 
tests, and provide guidance on 
evaluation and reporting of data, further 
guidance on when data are required, 
and examples of recommended testing 
protocols. The Agency must conduct a 
complete evaluation and review of the 
data submitted to support a pesticide 
registration prior to the Agency's 
determination of the registerability of 
the product with respect Ur the criteria 
set forth in 40 CFR 162.7(d) arid (e) and 
162.18-4. 
More recently, the Ageney has issued 
a statement of interim policy on small- 
scale field testing of nonindigenous and 
genetically engineered microbial 
pesticides. This policy, published in the 
Federal Register of Octoberl7, 1984 (49 
FR 40659), is discussed in detail in Unit 
II. F. of this notice. 
D. Scope of This Unit 
This unit of the notice addresses those 
nonindigenous and genetically 
engineered microorganisms which are 
considered pesticides under FIFRA 
section 2(u) and which are defined as 
biological control agents. 40 CFR 
162.5(c)(4) currently specifies that 
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