Attachment II - Page 29 
Federal Register / Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 50683 
microorganisms, when used as 
pesticides, are regulated under F1FRA. 
As indicated in Unit I.B.4 above, the 
Agency has determined that certain non- 
microbial living organisms which fall 
within the definition of biological 
control agents are already addressed by 
other agencies, specifically USDA and 
the Department of the Interior (DOI). 
Examples of these biological control 
agents are vertebrates, insect predators, 
nematodes, and macroscopic parasites. 
Therefore, pursuant to section 25(b) of 
FIFRA and 40 CFR 162-5(c)(4), these non- 
microbial biological control agents have 
been exempted from regulation under 
FIFRA. However, if EPA, in cooperation 
with other agencies, determines that 
certain biological control agents 
exempted by $ 162.5(c)(4) are not being 
adequately regulated, these organisms 
would be referred to the attention of the 
appropriate agency, or would be added 
to the exceptions in { 162.5(c)(4) by 
amendment. In the latter case, those 
organisms would no longer be 
considered exempt from the provisions 
of FIFRA. 
This unit of the notice does not 
address any chemical pesticide product, 
or chemical byproduct produced by 
microorganisms. Such chemicals are 
covered under current pesticide 
regulations, registration procedures, 
data requirements, and testing 
guidelines (see 40 CFR Parts 158 through 
180; and Subdivisions D through O of the 
Pesticide Assessment Guidelines). 
C. Background /History 
1. Past activities related to microbial 
pesticides. The first microbial pesticide 
[Bacillus popilliae ) was registered in 
1948. This pesticide was made of 
naturally occurring bacteria. However, it 
was not until the late 1960s and early 
19708 that interest in microbial 
pesticides began to increase. As of 1983, 
there were 14 microbial pesticides used 
in about 100 separate products 
registered for use in agriculture, forestry, 
mosquito control, and homeowner 
situations. 
In recognition of the growing interest 
and concern about microbial pesticides, 
the Agency began (in 1974) sponsoring a 
variety of workshops, symposia, and 
panel discussions aimed at identifying 
the relevant safety concerns for 
microbial pesticides. As early as 1978, at 
an EPA symposium title “Viral 
Pesticides; Present Knowledge and 
Potential Effect on Public and 
Environmental Health," the need for 
sensitive identification and detection 
methods as well as quality assurance 
provisions were clearly identified. In the 
same year, intramural and extramural 
research on developing methods for 
molecular characterization and genetic 
mapping of entromopathogenic viruses 
was initiated. 
OPP issued a Policy Statement on 
Diorational Pesticides which was 
published in the Federal Register of May 
14, 1979, (44 FR 23994). In it, OPP 
recognized microbial pesticides as 
distinct from conventional chemical 
pesticides, and committed OPP to 
developing appropriate testing 
guidelines within 2 years. In 1979, OPP 
commissioned an American Institute of 
Biological Sciences’ expert panel to 
develop a “Human Hazard Evaluation 
Scheme for Biorational Pesticides." The 
final report of this expert panel formed 
the basis for the human toxicology unit 
of the testing guidelines for microbial 
pesticides. The next year. OPP formally 
requested the EPA Offices of Research 
and Development (ORD) to develop and 
validate test methods for evaluating the 
safety of microbial pesticides to humans 
and the environment. 
OPP completed draft testing 
guidelines for Microbial and 
Biochemical Pesticides in 1980. The 
biochemical pest control agents include 
pheromones, hormones, natural insect 
and plant growth regulators, and 
enzymes, and the microbial pest control 
agents include bacteria, viruses, fungi, 
and protozoa. After review by the 
FIFRA Scientific Advisory Panel (SAP) 
and public comment, these guidelines 
were published as Subdivision M of the 
Pesticides Assessment Guidelines 
through theNTIS in 1983. 
The microbial pesticide portion of the 
Subdivision M guidelines applies to both 
naturally occurring and genetically 
modified microbial pesticides. However, 
the specific data that would be required 
for the registration of genetically 
modified microorganisms would be 
determined on a case-by-case basis by 
EPA. This approach was supported in 
the final report (September 1983) of the 
Biorational Workshop (September 15-17, 
1982) that was sponsored by ORD at the 
request of OPP. The Workshop was 
designed primarily to evaluate and 
review Subdivision M and the status of 
testing for the safety of microbial and 
biochemical pesticides to nontarget, 
nonhuman organisms; however, safety 
concerns relating to all nontargets, 
including humans were addressed. The 
workshop final report made a number of 
recommendations for improving the 
guidelines, but concurred with the 
philosophy and with the tiered testing 
scheme, and generally agreed with the 
safety testing proposed for registering 
naturally occurring microorganisms. 
Concerning genetically modified 
microbial pesticides, the report stated in 
part that 
. . . each situation (application for 
registration) wifi require a case-by-caae 
determination of test requirements for 
registration. . . The consensus was that any 
undesirable effects of genetically engineered 
agents could be detected in Tier 1 level 
testing or any specially designed tests 
appropriate for the agent to be evaluated. 
The Data Requirements for Pesticide 
Registration, 40 CFR Part 158. contain 
data requirements for microbial 
pesticides (including genetically 
engineered microbial pesticides) at 
§ 158.170. These data requirements were 
previously reviewed by the FIFRA SAP 
as part of Subdvision M of the Pesticide 
Assessment Guidelines. 
In 1983, OPP received its first inquiry 
regarding the applicability of FIFRA to a 
genetically modified substance, a 
bacterium to control ice nncleation on 
certain kinds of crops. The applicability 
of FIFRA to a naturally occurring non- 
ice nucleating bacterium was also 
considered at that time. The Agency 
concluded that bacteria which inhibit 
ice nucleation, whether naturally 
occurring or genetically engineered, are 
pesticides and fall under FIFRA 
jurisdiction (Ref. 1). 
Recently, the Agency has addressed 
the issue of small-scale field testing of 
nonindigenous and genetically 
engineered microbial pesticides. As an 
Interim policy, EPA is requiring 
notification under FIFRA prior to these 
activities in order to determine the need 
for experimental use permits. This 
interim policy, published in the Federal 
Register of October 17, 1984 (49 FR 
40659), is discussed in detail in Unit U.F 
of this notice. 
2. Concerns related to microbial 
pesticides. Microbial pesticides, when 
naturally occurring and indigenous to 
the area of intended use, generally raise 
fewer risk concerns than conventional 
chemical pesticides. With regard to 
indigenous microbial pesticides, the 
Agency has already identified a basis 
for concern and hence, the need for 
adequate regulation under FIFRA. 
When a microbe is applied as a pesticide in 
the environment, great numbers of the 
microbes are released outside (apart from) 
their host, at a discrete point, in time (day of 
application), and spread over the biotic and 
abiotic components of the environment as 
well as adjacent areas (due to drift); hence, in 
terms of the number of nontarget organisms 
exposed, the number of different species 
exposed (both humans and non-human), and 
the degree of exposure (number of microbes 
per nontarget organism), exposure (to the 
microbe as a pesticide] would probably be 
greater than under natural conditions. 
(Pesticide Assessment Guidelines, 
Subdivision M, p. 45.) 
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