[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: 40CFR172.4]

[Page 254-255]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 172--EXPERIMENTAL USE PERMITS--Table of Contents
 
         Subpart A--Federal Issuance of Experimental Use Permits
 
Sec. 172.4  Applications.

    (a) Time for submission. An application or request for amendment to 
an existing permit shall be submitted in triplicate to the Registration 
Division, Office of Pesticide Programs, Environmental Protection Agency, 
Washington, DC 20460, as far as possible in advance of the intended date 
of shipment or use. Applications will be processed as expeditiously as 
possible.
    (b) Contents of applications--(1) General requirements. (i) The name 
and address of the applicant;
    (ii) The registration number of the product, if registered;
    (iii) The purpose or objectives of the proposed testing; a 
description in detail of the proposed testing program including test 
parameters; a designation of the pest organism(s) involved; the amount 
of pesticide product proposed for use; the crops, fauna, flora, sites, 
modes, dosage rates, and situation of application on or in which the 
pesticide is to be used; the States in which the proposed program will 
be conducted; 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; 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;
    (iv) The name, street address, telephone number, and qualifications 
of all participants in the program (whether or not in the employ of the 
applicant). A permit must be amended to add or change participants;
    (v) The name and street address of all cooperators, if available at 
the time an application is submitted or as soon thereafter as available;
    (vi) A description and the specific results of any appropriate prior 
testing of the product conducted by the applicant to determine toxicity 
and effects in or on target organisms at the site of application; and to 
determine phytotoxicity and other forms of toxicity or effects on 
nontarget plants, animals, and insects at or near the site of 
application; and to determine adverse effects on the environment;
    (vii) The proposed method of storage and disposition of any unused 
experimental use pesticide and its containers; and
    (viii) Such other additional pertinent information as the 
Administrator may require.
    (2) Requirement for tolerance. If the experimental use pesticide is 
to be used in such a manner that any residue can reasonably be expected 
to result in or on food or feed, the applicant must:
    (i) Submit evidence that a tolerance or exemption from the 
requirement of a tolerance has been established for residues of the 
pesticide in or on such food or feed under section 408 of the Federal 
Food, Drug, and Cosmetic Act, or a regulation promulgated under section 
409 of that Act; or
    (ii) Submit a petition proposing establishment of a tolerance or an 
exemption from the requirement of a tolerance under section 408, or a 
regulation under section 409, of the Federal Food, Drug, and Cosmetic 
Act; or
    (iii) Certify that the food or feed derived from the experimental 
program

[[Page 255]]

will be destroyed or fed only to experimental animals for testing 
purposes, or otherwise disposed of in a manner which will not endanger 
man or the environment. The method of such destruction or disposition 
shall be provided in the application for the permit.
    (3) Additional requirements for unregistered pesticide products. (i) 
A complete confidential statement of composition for the formulation to 
be tested giving the name and percentage by weight of each ingredient, 
active and inert;
    (ii) Chemical and physical properties of each active ingredient of 
the formulation to be tested, including, but not limited to, the 
manufacturing or laboratory processes and analytical methods suitable 
for determining the active ingredients in the formulation;
    (iii) Appropriate date, if available, on the rate of decline of 
residues on the treated crop or environmental site or other information 
for determination regarding entry of persons into treated areas; and
    (iv) Results of toxicity tests and other data relevant to the 
product's potential for causing injury to the users or other persons who 
may be exposed, including any available epidemiological information as 
to man.
    (c) Fees. The payment of fees for experimental use permits shall 
apply as specified in subpart U of part 152 of the chapter.

[40 FR 18782, Apr. 30, 1975, as amended at 53 FR 19115, May 26, 1988]