Attachment II - Page 30 
50884 Federal Register / 
Many of the same types of concerns 
apply to both indigenous (naturally 
occurring) microbial pesticides end to 
nonindigenous and genetically 
engineered microbial pesticides, namely; 
infectivity, pathogenicity, toxicity, host 
range, virulence, and survivability. 
However, the Agency recognizes that 
potentially greater risks may exist from 
the use of nonindigenous and genetically 
engineered microoganisms as pesticides. 
For example, they could exhibit a 
broader host range, a new toxin, 
enhanced virulence, greater 
survivability, or greater competitiveness 
than their indigenous "parent” 
microorganisms. This could be 
accomplished by using techniques which 
alter or manipulate a naturally occurring 
microorganism’s genetic make up (for 
example, using recombinant DNA 
(rDNA) techniques). 
One of the Agency's major concerns Is 
that risks which are specific to 
nonindigenous and genetically 
engineered microbial pesticides would 
not be identified by the currently 
established testing scheme for naturally 
occuring (indigenous) microbial 
pesticides. Similarly, the Agency is 
concerned about the stability of the 
genetic material in a genetically 
modified microbial pesticide and about 
the specificity of an inserted gene 
segment. For example, our current data 
requirements would yield no 
information about the characteristics 
that the inserted genes are intended to 
express, and the potential for other 
characteristics to be unknowingly 
inserted and expressed. A related 
concern is the potential for transfer of 
genes from the genetically modified 
microbial pesticide to naturally 
occurring microorganisms, and thereby 
generating new potential risks. This 
phenomenon is known to occur with the 
transfer of genes controlling antibiotic 
resistance to organisms without known 
contact to antibiotics. 
D. Current Regulatory Status of 
Microbial Pesiticides 
The pesticide data requirements, 
codified at 40 CFR 158.170, are 
applicable to microbial pesticides, both 
naturally occurring and otherwise. The 
Agency believes that these requirements 
are adequate for the assessment of 
indigenous microbial pesticides, and 
provide a basis for evaluating 
nonindigenous and genetically 
engineering microbial pesticides as well. 
However, the Agency believes that 
additional data or information, on a 
case-by-case basis, may be necessary to 
evaluate certain properties of 
nonindigenous and genetically 
engineered microbial pesticides. Part 158 
Vol. 49, No. 252 / Monday, December 31. 1984 / Notices 
explicitly provides the necessary 
flexibility to require additional data in 
this situation (§ 158.65) as well as the 
flexibility to waive data requirements 
that are not applicable (5 158.45). 
Nonindigenous and genetically 
engineered microbial pesticides would 
be subject to additional data 
requirements or information 
requirements as needed, depending on 
the particular microorganism, its parent 
microorganism, the proposed pesticide 
use pattern, and the manner and extent 
to which the organism has been altered 
or modified. Other requirements could 
include information on the genetic 
modification techniques used, the 
identity of the inserted gene segment 
(base sequence data or enzyme 
restriction map of the gene), information 
on the control region of the genes, a 
description of the new traits or 
characteristics that are Intended to be 
expressed, tests to evaluate genetic 
stability and exchange, and/or selected 
Tier II environmental fate and 
toxicology tests. 
OPP has broadened its definition of 
genetic engineering beyond that 
presented in Subdivision M of the 
Pesticide Assessment Guidelines to 
include more than just microbial 
pesticides modified by rDNA 
techniques. Therefore, microorganisms 
modifed by rRNA techniques as well as 
by cell fusion, conjugation, 
microencapsulation, microinjection, 
directed or undirected mutagenesis, 
plasmid transfer, transformation, etc., 
are Included. 
E. Plan for Reviewing and Registering 
Nonindigenous and Genetically 
Engineered Microbial Pesticides Under 
FIFRA 
This Unit describes the Agency’s plar 
for reviewing and registering 
nonindigenous and genetically 
engineered microbial pesticides in order 
to estimate or predict potential human 
or ecological effects and the 
environmental fate of such mircrobial 
pesticides after their release into the 
environment. The Agency is seeking 
public comments on the merits of this 
plan. Appropriate revisions in the plan 
will be made by the Agency after review 
and evaluation of the comments. 
1. Proposed plan. The Agency has 
developed the following strategy for 
considering the scientific and regulatory 
issues pertaining to nonindigenous and 
genetically engineered microbial 
pesticides: 
a. The established procedures and 
policies for registering pesticides as 
specified under 40 CFR Parts 150 
through 189 will apply to nonindigenous 
and genetically engineered microbial 
pesticides. 
b. Upon receipt of the application for 
registration, a Federal Register notice 
will be prepared to announce the receipt 
publicly. The fact that the submission is 
for a nonindigenous or genetically 
engineered microbial pesticide will be 
highlighted In the notice. The notice will 
be mailed to interested groups and 
public comment will be solicited. 
c. The data and information 
requirements specified in 40 CFR 158.65 
and 158.170 will apply to nonindigenous 
and genetically engineered microbial 
pesticides. 
d. Any additional data requirements 
will be determined on a case-by-case 
basis depending on the particular 
microorganism, its parent 
microorganism, the pesticide use 
pattern, and the manner and extent to 
which the microorganism has been 
altered/manipulated. These additional 
requirements could include: 
i. Information on natural predators 
and parasites. 
ii. Description of the natural habitat of 
the microorganism. 
iii. A comparison of the natural 
habitat with the proposed use site. 
iv. Information on the methods used to 
genetically alter the microbe. 
v. The identity of the engineering 
techniques used. 
vi. Information on the control region 
of the genes. 
vii. A description of the new traits or 
characteristics that are intended to be 
expressed. 
viii. Tests to evaluate genetic stability, 
transfer, and exchange. 
ix. Selected Tier II environmental fate 
tests. 
x. Selected Tier II toxicology tests. 
e. Requests for waivers of any of the 
requirements of Part 158.170 will be 
evaluated on a case-by-case basis 
depending on the particular 
microorganism, its parent 
microorganism, the pesticide use 
pattern, and the manner and extent to 
which the microorganism has been 
altered or manipulated. 
f. OPP will encourage potential 
registration applicants to meet with 
representatives of the Registration 
Division and the Hazard Evaluation 
Division (HED) prior to submission of 
their application to discuss their product 
and determine whether additional data 
beyond that specified in Part 158 would 
be necessary to evaluate the product 
and whether a waiver is warranted for 
any of the requirements in Part 158. 
g. OPP will seek informal scientific 
consultation during the pesticide 
application review process. This may 
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