§ 172.48 - Data requirements for a notification.

§ 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.

(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.