Attachment II - Page 32 
50886 Federal Register / Vol. 49, No. 252 / Monday, December 31, 1984 / Notices 
Notification should include adequate 
information to allow the Agency to 
evaluate the sinall-scule field testing 
program. Each notification should 
include the following information, or, 
where specific information is not 
submitted, documentation of why it is 
not practicable or necessary to provide 
the information: 
1. Background information on the 
nonindigenous or genetically engineered 
microorganisms. 
a. Identity of the microbe and means 
of detection using the most sensitive and 
specific methods available. 
b. Description of the natural habitat of 
the nonindigenous or parental 
microorganism, including information on 
natural predators and parasites. 
c. Information on infectivity and 
pathogenicity to nontarget organisms. 
d. Information on the growth and 
survival of the microbe in the 
environment (e.g., laboratory or 
containment facility test data). 
e. If the microbe is genetically altered, 
the following information should be 
provided in addition to the information 
listed in numbers 1 through 4 above: 
(1) Information on the methods used 
to genetically alter the microbes, if any. 
(2) The identity of the inserted/ 
deleted gene segment in question (host 
source, nature, base sequence data, or 
enzyme restriction map of the gene). 
(3) Information on the control region 
of the genes, and a description of the 
new traits or characteristics that are 
intended to be expressed. 
(4) Information on genetic transfer and 
exchange with other organisms. 
2. Description of proposed test. 
a. The purpose or objectives of the 
proposed testing. 
b. A detailed description of the 
proposed testing program, including test 
parameters. 
c. A designation of the pest 
organism(s) involved (common and 
scientific names). 
d. A statement of composition for the 
formulation to be tested, giving the 
name and percentage by weight of each 
ingredient, active and inert, and where 
applicable the number of viable 
microorganisms per unit weight or 
volume of the product (or other 
appropriate system for designating the 
quantity of active ingredient). 
e. The amount of pesticide product 
proposed for use and the method of 
application. 
f. The States in which the proposed 
program will be conducted, and specific 
identification of the exact location of the 
test site(s). 
g. The crops, fauna, flora, 
geographical description of sites, modes, 
dosage rates, frequency, and situation of 
application on or in which the pesticide 
is to be used. 
h. A comparison of the natural habitat 
with the proposed test site. 
i. The number of acres, number of 
structural sites, or number of animals by 
State to be treated or included in the 
area of experimental use and the 
procedure to be used to protect the test 
from intrusion by unauthorized 
individuals. 
j. The proposed dates or period(s) 
during which the testing program is to 
be conducted, and the manner in which 
supervision of the program will be 
accomplished. 
k. A description of the program for 
monitoring and containment of the 
microorganism during the field test 
l. The method of disposal or sanitation 
of plants, animals, soils, etc., which 
were exposed during or after the field 
test. 
m. Means of evaluating potential 
adverse effects and methods of 
controlling the microorganism if 
detected beyond the test area. 
Upon notification, the Agency will 
have 90 days to evaluate the notice. 
Applicants would be free to perform 
their field test after that time period 
unless otherwise informed by the 
Agency. 
The Agency also considered two other 
options when developing the interim 
policy. First, the Agency could treat 
nonindigenous and genetically 
engineered microbial pesticides under 
existing regulations in,the same manner 
as indigenous microbial pesticides and 
chemical pesticides and not require an 
EUP or notification when the field test 
meets the criteria in S 172.3. This option 
would not impede innovation or product 
development of nonindigenous and 
genetically engineered microbial 
pesticides. However, it does not address 
the potential risks from direct 
environmental release of these 
microbes; it raises the question of 
whether the Agency is doing all that it 
should to prevent unreasonable adverse 
effects to humans or the environment; 
and it is inconsistent with the NIH RAC 
guidelines which require approval 
before rDNA altered microorganisms 
under its jurisdiction are tested in the 
environment. Second, the Agency could 
require an EUP for all field testing 
regardless of the acreage involved. 
While this option addresses the risk 
from direct environmental release, it 
could result in time delays and/or 
increased costs, which, in turn, would 
impede innovation, and impede the 
development of microbial pesticides 
which do not cause unreasonable 
adverse effects. The Agency believes 
that the notification procedures set out 
in the interim policy will allow EPA to 
evaluate the potential risks involved 
with field testing nonindigenous and 
genetically engineered microbial 
pesticides, while having only a minimal 
impact on the development of beneficial 
microbial pesticides for use in the 
environment. 
In issuing the interim procedures on 
October 17th, 1984, the Agency 
emphasized that it is an interim policy, 
subject to revision based on the 
comments received in response to that 
notice and the Agency's experiences in 
implementing the interim policy. In 
addition, comments received in 
response to this notice will be 
considered in formulating a final policy 
on small-scale field testing of 
nonindigenous and genetically 
engineered microbial pesticides. 
III. Applicability of TSCA to Products of 
Biotochnology 
A. General Scope of TSCA 
TSCA, which was enacted in 1976, 
provides the Federal Government with 
authority to address risks posed by a 
broad range of “chemical substances.” 
TSCA gives EPA authority to assess and 
control exposure to such substances 
through all phases of their commercial 
lifecycle — including research and 
development, commercial production, 
use, and disposal. A central feature of 
the Act is its focus on prevention and its 
emphasis on information development. 
By requiring EPA to review new 
substances before manufacture, and by 
giving it authority to require testing, 
TSCA makes it possible to act against 
risks before harm occurs, rather than 
after the damage has been done. 
1. Applicability to living organisms. 
TSCA provides EPA authority to review 
and regulate "chemical substances" In 
general commercial and other 
applications. As defined in section 3(2) 
of the Act, a “chemical substance" is 
“any organic or inorganic substance of a 
particular molecular identity, including 
(i) any combination of such substances 
occuring in whole or in part as a result 
of a chemical reaction or occurring in 
nature. . . ." EPA’s authority to review 
living organisms under TSCA is based 
on this definition. A living organism is a 
“combination of such substances 
occuring in whole or in part as a result 
of a chemical reaction or in part as a 
result of a chemical reaction or 
occurring in nature. . . .” Also, any 
DNA molecule, other nucleic acid, or 
other constituent of a cell, however 
created, is "an organic substance of a 
particular molecular identity." 
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