[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: 40CFR172.3]



[Page 252-253]

 

                   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.  172.3  Scope of requirement.



    (a) An experimental use permit (EUP) is generally required for 

testing of any unregistered pesticide or any registered pesticide being 

tested for an unregistered use. However, as described in paragraph (b) 

of this section, certain of such tests are presumed not to involve 

unreasonable adverse effects and, therefore, do not require an EUP.

    (b) Except as provided in subpart C of this part or as specifically 

determined by the Environmental Protection Agency (EPA), it may be 

presumed that EUPs are not required when:

    (1) The experimental use of the pesticide is limited to:

    (i) Laboratory or greenhouse tests,

    (ii) Limited replicated field trials as described in paragraph (c) 

of this section to confirm such tests, or

    (iii) Other tests as described in paragraph (c) of this section 

whose purpose is only to assess the pesticide's potential efficacy, 

toxicity, or other properties.

    (2) The producer, applicator, or any other person conducting the 

test does not expect to receive any benefit in pest control from the 

pesticide's use.

    (c) For purposes of paragraphs (b)(1)(ii) and (b)(1)(iii) of this 

section, the following types of experimental tests are presumed not to 

need an EUP:

    (1) A small-scale test involving use of a particular pesticide that 

is conducted on a cumulative total of no more than 10 acres of land per 

pest, except that:

    (i) When testing for more than one target pest occurs at the same 

time and in the same locality, the 10 acre limitation shall encompass 

all of the target pests.

    (ii) Any food or feed crops involved in, or affected by, such tests 

(including, but not limited to, crops subsequently grown on such land 

which may reasonably be expected to contain residues of the tested 

pesticides) shall be destroyed or consumed only by experimental animals 

unless an appropriate tolerance or exemption from a tolerance has been 

established under the Federal Food, Drug, and Cosmetic Act (FFDCA) for 

residues of the pesticide.

    (2) A small-scale test involving the use of a particular pesticide 

that is conducted on a cumulative total of no more than 1 surface acre 

of water per pest, except that:

    (i) When the testing for more than one target pest occurs at the 

same time and in the same locality, the 1 acre limitation shall 

encompass all of the target pests.

    (ii) Waters which are involved in or affected by such tests are not 

used for irrigation purposes, drinking water supplies, or body contact 

recreational activities.

    (iii) Testing shall not be conducted in any waters which contain or 

affect fish, shellfish, plants, or animals taken for recreational or 

commercial purposes and used for food or feed, unless an appropriate 

tolerance or exemption from a tolerance has been established under the 

FFDCA for residues of the pesticide.

    (3) Animal treatment tests involving the use of a particular 

pesticide that are conducted only on experimental animals which will not 

be used for food or feed, unless an appropriate tolerance or an 

exemption from a tolerance has been established for animal products and 

byproducts under the FFDCA for residues of the pesticide.

    (d) The examples in paragraphs (c)(1), (c)(2), and (c)(3) of this 

section are not all-inclusive and do not preclude testing in larger 

areas or larger numbers of



[[Page 253]]



units if the intended use meets the criteria of paragraph (a) of this 

section. However, tests which do not come within the examples in 

paragraphs (c)(1), (c)(2), and (c)(3) of this section, absent a specific 

determination by EPA to the contrary, require an EUP. Subdivision I of 

the Pesticide Assessment Guidelines provides guidance on the procedures, 

data requirements, and general aspects pertaining to the issuance and 

use of EUPs. Persons intending to conduct tests who are uncertain 

whether the testing may be conducted without a permit may submit a 

request for determination to the Office of Pesticide Programs' Document 

Processing Desk at the appropriate address as set forth in 40 CFR 

150.17(a) or (b). Such a request shall include the information listed in 

Sec.  172.4(b)(1)(ii) and (b)(1)(iii) and in the case of an unregistered 

product, the information in Sec.  172.4(b)(3)(i).

    (e) Notwithstanding paragraphs (b) through (d) of this section, EPA 

may, on a case-by-case basis, require that certain testing of a 

particular pesticide or class of pesticides be carried out under an EUP, 

if it is determined that such EPA oversight is warranted. If EPA 

determines that an EUP is required, it will notify the developer of the 

pesticide of the need for an EUP and provide opportunity for comment or 

objections before imposing the requirement.

    (f) No EUP is required for a substance or mixture of substances 

being put through tests for the sole purpose of gathering data required 

for approval of such substance or mixture under the FFDCA (21 U.S.C. 301 

et seq.) as:

    (1) A ``new drug'' (21 U.S.C. sec. 321(p) and sec. 355).

    (2) A ``new animal drug'' (21 U.S.C. sec. 321(w) and sec. 360(b)), 

or

    (3) An ``animal feed'' (21 U.S.C. sec. 321 (x)) containing a ``new 

animal drug'' (21 U.S.C. sec. 360(b)).

    (g) Paragraph (f) of this section shall not apply when a purpose of 

such test is to accumulate information necessary to register a pesticide 

under section 3 of the Act.



[59 FR 45611, Sept. 1, 1994, as amended at 71 FR 35546, June 21, 2006]