[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR172.4]



[Page 253-254]

 

                   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; 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



[[Page 254]]



    (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]