Attachment II - Page 31 
Federal Register / Vol. 49, No. 252 / Monday, December 31, 1964 / Notices 50885 
include ORD, OTS, the National 
Institutes of Health (NIH) Recombinant 
DNA Advisory Committee (RAC) and 
other departments and agencies as 
appropriate. Any consultation will be 
within the constraints of OFF’S 
Confidential Business Information (CBI) 
policies. 
h. As needed, OPP will request the 
FIFRA SAP to consider any significant 
questions/concems, the need for 
additional information/data, and/or to 
perform a technical review of OPP’s 
decision concerning the request for 
registration. It may be necessary to 
request that the SAP form a subpanel of 
experts to perform this review. This 
subpanel should include expert 
representatives from the NIH RAC, 
EPA’s Scientific Advisory Board (SAB), 
and ORD. 
i. OPP will announce the final 
decision in a Federal Register notice. 
Past experience indicates that the 
registration process for a new microbial 
pesticide may vary from 9 months to 
several years depending upon the 
particular product, its use pattern, and 
the completeness of the registration 
package submitted to EPA. 
2. Long term strategy under FIFRA. 
OPP will develop more explicit 
procedures and/or requirements for 
evaluating nonindigenous and 
genetically engineered microbial 
pesticides. Toward this end, OPP plans 
to take the following steps over the next 
few years: 
a. OPP will solicit the 
recommendations of various groups 
(e.g., government, academic, public 
interest, and industrial) regarding the 
evaluation of nonindigenous and 
genetically engineered microbial 
pesticides and the environment This 
will include further consultation with 
the participants of the ORD workshop 
held in 1982 at Gulf Breeze as well as 
consultation with NIH, USDA, FDA, 
National Institute for Occupational 
Safety and Health, and the 
biotechnology industry. Also, the 
recommendations from EPA's 
Biotechnology Workshops will be 
reviewed and evaluated. (See the Public 
Record for. further information on these 
Workshops.) 
b. Based on findings from the 
consultations described above, OPP 
should then be able to better identify 
additional potential hazards or risks 
posed by nonindigenous and genetically 
engineered microorganisms, and the 
testing or additional research that would 
be neeed to evaluate any potential 
nazards. 
c. EPA will evaluate the question of 
when and whether data developd on 
one microorganism can be used to 
support the registration of another, 
closely related microorganism (e.g., a 
closely related strain of the same 
species), within the constraints of the 
exclusive use and data compensation 
provisions of FIFRA. 
d. EPA will modify 40 CFR Part 158, 
Subdivision M, and its regulatory 
policies and procedures. Current 
indications are that, at a minimum, 
certain additional information will be 
required and perhaps some additional 
test data to address questions pertaining 
to host spectrum and stability of 
engineered agents. 
F. Small-ScaleField Testing 
Prior to obtaining a registration for a 
pesticide product, applicants generally 
need to conduct field studies in order to 
gather product performance, use, and 
other data necessary to support the 
registration of their product. Section 5 of 
FIFRA provides that a person may 
obtain an experimental use permit (EUP) 
authorizing limited use of an 
unregistered product or use of a 
registered product for an unregistered 
use before conducting field studies. 40 
CFR Part 172 sets forth the regulations 
pertaining to EUPs, and Part 158 
specifies the data required to be 
submitted to EPA before EPA will issue 
an EUP. 
The conditions under which an EUP is 
required are specified at 40 CFR Part 
172, which also provides guidance on 
how to determine whether an EUP must 
be obtained. Pursuant to § 172.3, when a 
chemical or indigenous microorganism is 
being field tested only to determine 
whether it has value for pesticide 
purposes or to determine its toxicity or 
other properties, and the person 
conducting the test does not expect to 
receive and benefit in pest control from 
its use, an experimental use permit has 
not normally been required. 
The Agency has, in the past, exercised 
considerable judgment and flexibility in 
determining when an EUP is required. 
As provided in $ 172.3, EPA now 
presumes that testing of a chemical or 
indigenous microorganism in small-scale 
field studies is for the purpose described 
above. Therefore, an EUP has not 
normally been required to support such 
testing. Small-scale field studies are 
described in § 172.3(a): in summary, they 
comprise (1) small-scale terrestrial field 
studies that involve less than 10 acres of 
land, provided that any food crops 
involved in or affected by such tests 
shall be destroyed or consumed only by 
experimental animals unless a tolerance 
or exemption from tolerance has been 
established; (2) small-scale aquatic field 
studies that involve less than one 
surface acre of water, provided that 
waters that are involved in or affected 
by such tests will not be used for 
irrigation purposes, drinking water 
supplies, or body-contact recreational 
activities. Also, no such test shall be 
conducted in waters that contain any 
fish, shellfish, or other plants or animal' 
taken for recreation or commercial 
purposes and used for food or feed 
unless a tolerance or exemption from 
tolerance has been established. 
In situations where even small-scale 
field studies posed a serious 
environmental or human health concern, 
EPA has required an EUP. Section 172-3 
explicitly recognizes that a wide variety 
of testing situations may arise, and that 
a flexible regulatory approach is needed 
to deal with these situations. 
Chemical pesticides have no 
independent mobility and reproductive 
capability and therefore when applied in 
small-scale field studies their potential 
for causing adverse effects outside the 
treated area is extremely limited. 
Microbial pesticides, however, may 
replicate and spread beyond the site of 
application. Further, nonindigenous and 
genetically engineered microbial 
pesticides may not be subject to natural 
control or dissipation mechanisms; they 
may be capable of spreading beyond the 
site of application with potential 
adverse effects. Therefore, small-scale 
field studies with nonindigenous and 
genetically engineered microbial 
pesticides would raise many of the same 
concerns as more extensive use of 
conventional pestiddea. 
The agency is considering a change in 
40 CFR 172.3 to require that applicants 
notify the Agency before they conduct 
small-scale field studies with 
nonindigenous and genetically 
engineered microbial pesticides and is 
interested in comments on the merits of 
this position. Until the Agency adopts a 
final approach to these pesticides, which 
will include the opportunity for public 
comment, notification is being required 
as an interim procedure for all small- 
scale field studies involving the direct 
release of nonindigenous and genetically 
engineered microbial pesticides into the 
environment. This interim procedure 
does not apply to studies conducted in 
contained laboratory, growth chamber, 
greenhouse, or other facilities where 
there is no direct release of the 
microbial pesticide into the 
environment Notice of this interim 
policy, with s request for comments, 
was published in the Federal Register of 
October 17, 1984 (49 FR 40659). Based on 
the information contained in the 
notification, the Agency will determine 
whether an EUP is required. 
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