[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR172.48]

[Page 265-266]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
   Subpart C--Notification for Certain Genetically Modified Microbial 
                               Pesticides
 
Sec. 172.48  Data requirements for a notification.

    This section identifies the data and information to be included in 
each Notification. When specific information is not submitted, an 
explanation of why it is not practical or necessary to provide the 
information is to be provided.
    (a) The identity of the microorganism which constitutes the 
microbial pesticide including:
    (1) Summary of data supporting the taxonomic designation and its 
interpretation.
    (2) Means and limit of detection using sensitive and specific 
methods (e.g., note the use of any markers that are used to distinguish 
the introduced population from native microorganisms). Introduction into 
the microbial pesticide of a unique genetic marker is encouraged.
    (b) Description of the natural habitat of the parental strain of the 
microbial pesticide including information on:
    (1) Physical and chemical features important to growth and survival 
of the parental strain.
    (2) Biological features of the parental strain that would have an 
impact on the microbial pesticide (e.g., presence of phages that infect 
the microorganism).
    (3) Competitors.
    (c) Information on the host range of the microbial pesticide, if 
any, with an assessment of infectivity and pathogenicity to nontarget 
organisms.
    (d) Information on survival and the ability of the microbial 
pesticide to increase in numbers (biomass) in the environment (e.g., in 
the environment into which the microbial pesticide will be introduced, 
and in substantially different environments that may be in the immediate 
vicinity). These data may be derived from the scientific literature or 
from tests conducted in a laboratory or other containment facility.
    (e) The identity of possible transmission vectors (e.g., insects).
    (f) Data on relative environmental competitiveness compared to the 
parental strain of the microbial pesticide.
    (g) Description of the methods used to genetically modify the 
microbial pesticide.
    (h) The identity and location of the gene segments that have been 
rearranged or inserted/deleted (host source, nature, and, for example, 
base sequence data, or restriction enzyme map of the genes).
    (i) Information on the control region of the genes, and a 
description of the new traits or characteristics that are expressed.
    (j) Data on potential for genetic transfer and exchange with other 
organisms and on genetic stability of any inserted sequences in the 
microbial pesticide.

[[Page 266]]

    (k) A description of the proposed testing program including:
    (1) The purpose or objectives of the proposed testing.
    (2) Designation of the pest organisms involved (common and 
scientific names).
    (3) The States in which the proposed program will be conducted.
    (4) The exact location of the test sites (including proximity to 
residences and human activities, surface water, etc.).
    (5) 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.
    (6) The total amount of pesticide product proposed for use in the 
testing.
    (7) The method of application.
    (8) A comparison of the natural habitat of the microbial pesticide 
with the proposed test site.
    (9) The number of acres, structural sites, or animals/plants by 
State, to be treated or included in the area of experimental use.
    (10) Procedures to be used to protect the test area from intrusion 
by unauthorized individuals.
    (11) The proposed dates or periods during which the testing program 
is to be conducted, and the manner in which supervision of the program 
will be accomplished.
    (12) Description of procedures for monitoring the microbial 
pesticide within and adjacent to the test site during the test.
    (13) The method of sanitation or disposal of plants, animals, soils, 
farm tools, machinery etc., that will be exposed to the microbial 
pesticide during or after the test.
    (14) Means of evaluating potential adverse effects and methods of 
controlling the microbial pesticide if detected beyond the test area.
    (l) A statement of composition for the formulation to be tested, 
giving:
    (1) The name and percentage by weight (or other suitable units) of 
each ingredient, active and inert.
    (2) Production methods.
    (3) Extraneous microorganisms present as contaminants.
    (4) Amount and potency of any toxin present.
    (5) 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.
    (m) Any additional factual information regarding the potential for 
unreasonable adverse effects on the environment.