[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR172.4]

[Page 287-288]
 
                   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 as far as possible in advance of 
the intended date of shipment or use to the Office of Pesticide 
Programs' Document Processing Desk at the appropriate address as set 
forth in 40 CFR 150.17(a) or (b).
    (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;

[[Page 288]]

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 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; 71 
FR 35546, June 21, 2006]