[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: 40CFR172.3]

[Page 286-287]
 
                   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

[[Page 287]]

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 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]