Attachment C

wreier-aviles on DSK5TPTVN1PROD with CFR

Environmental Protection Agency

Pt. 172

by a certified applicator, and he maintains the records required in this subsection. Each restricted use pesticide
retail dealer shall maintain records at
each individual dealership of each
transaction where a restricted use pesticide was made available to an
uncertified person for use by a certified
applicator. Records of each such transaction shall be maintained for a period
of 24 months after the date of the
transaction, and shall include the following information:
(A) The name and address of the residence or principal place of business of
the uncertified person to whom the restricted use pesticide is made available
for use by a certified applicator.
(B) The name and address of the residence or principal place of business of
the certified applicator who will use
the restricted use pesticide.
(C) The certified applicator’s certification number, the State (or other governmental unit) that issued his certification document, the expiration date
of the certification, and the categories
in which the applicator is certified, if
appropriate.
(D) The product name, EPA registration number, and the State special
local need registration number, granted under section 24(c) of the FIFRA (if
any) on the label of the pesticide.
(E) The quantity of the pesticide
made available for use in the transaction.
(F) The date of the transaction.
(G) At the time of each transaction,
EPA recommends that the dealer obtain the information required in paragraph (g)(2)(ii) (A) through (C) of this
section and assure himself that the restricted use pesticide is made available
for use by a certified applicator by examining one of the following sets of
documents:
(1) The original of the certified applicator’s certification document, and a
driver’s license or other State, county,
or Tribal identification document
issued to the uncertified person to
whom the restricted use pesticide is
made available.
(2) A photocopy or facsimile of the
certified applicator’s certification document, together with a statement
signed by the certified applicator authorizing the uncertified person to pur-

chase the restricted use pesticide on
his behalf, and a driver’s license or
other State, county, or Tribal identification document issued to the
uncertified person to whom the restricted use pesticide is made available.
(3) A photocopy or facsimile of the
certified applicator’s certification document, together with a copy of a
signed contract or agreement, between
the uncertified person to whom the restricted use pesticide is being made
available for use and the identified certified applicator, which provides for
the use of the restricted use pesticide
by the identified certified applicator,
and a driver’s license or other State,
county, or Tribal identification document issued to the uncertified person
to whom the restricted use pesticide is
made available.
(3) Availability of required records.
Each pesticide dealer shall, upon request of any officer or employee of
EPA duly designated by the Administrator, furnish or permit such person
at all reasonable times to have access
to and copy all records required to be
maintained under this section.
(4) Failure to comply. Any person who
fails to comply with the provisions of
this rule may be subject to civil or
criminal sanctions, under section 14 of
the Act, or 18 U.S.C. 1001. Violations include failure to submit or falsification
of any report required under this paragraph, failure to maintain or falsification of records as required under this
section, and making available for use
any pesticide classified for restricted
use to a person who is not a certified
commercial applicator other than in
accordance with these regulations and
section 3(d) of the amended FIFRA or
rules promulgated thereunder.
[43 FR 24837, June 8, 1978, as amended at 48
FR 29855, June 29, 1983; 48 FR 53974, Nov. 29,
1983; 49 FR 17759, Apr. 25, 1984; 58 FR 34203,
June 23, 1993; 77 FR 39642, July 5, 2012]

PART 172—EXPERIMENTAL USE
PERMITS
Subpart A—Federal Issuance of
Experimental Use Permits
Sec.
172.1

Definitions.

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§ 172.1

40 CFR Ch. I (7–1–13 Edition)

172.2 General.
172.3 Scope of requirement.
172.4 Applications.
172.5 The permit.
172.6 Labeling.
172.7 Importation of technical material.
172.8 Program surveillance and reporting of
data.
172.9 Renewals.
172.10 Refusals to issue and revocation.
172.11 Publication.

Subpart B—State Issuance of Experimental
Use Permits
172.20 Scope.
172.21 Definitions.
172.22 General.
172.23 State plans.
172.24 State issuance of permits.
172.25 Administration of State programs.
172.26 EPA review of permits.

[73 FR 75599, Dec. 12, 2008]

§ 172.2

Subpart C—Notification for Certain
Genetically Modified Microbial Pesticides
172.43 Definitions.
172.45 Requirement for a notification.
172.46 Submission of a notification.
172.48 Data requirements for a notification.
172.50 Response to a notification.
172.52 Notification exemption process.
172.57 Submission of information regarding
potential unreasonable adverse effects.
172.59 Enforcement.
AUTHORITY: 7 U.S.C. 136c, 136w. Section
172.4 is also issued under 31 U.S.C. 9701.
SOURCE: 40 FR 18782, Apr. 30, 1975, unless
otherwise noted.

Subpart A—Federal Issuance of
Experimental Use Permits

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and used solely for research purposes.
The term does not include animals intended to be used for any food purposes
Participant means any person acting
as a representative of the permittee
and responsible for making available
for use, or supervising the use or evaluation of, an experimental use pesticide to be applied at a specific application site.
Permittee means any applicant to
whom an experimental use permit has
been granted.
Value for pesticide purposes means
that characteristic of a substance or
mixture of substances which produces
an efficacious action on a pest.

§ 172.1 Definitions.
Terms used in this part have the
same meaning as in the Act. In addition, as used in this part, the following
terms shall apply:
Act means the Federal Insecticide,
Fungicide and Rodenticide Act, as
amended.
Applicant means any person who applies for an experimental use permit
pursuant to section 5 of the Act.
Cooperator means any person who
grants permission to a permittee or a
permittee’s designated participant for
the use of an experimental use pesticide at an application site owned or
controlled by the cooperator.
Experimental animals means individual animals or groups of animals,
regardless of species, intended for use

General.

(a) Pursuant to section 5 of the Federal
Insecticide,
Fungicide,
and
Rodenticide Act, as amended (86 Stat.
983), and except as herein provided by
§ 172.3, any person wishing to accumulate information necessary to register
under section 3 of the Act and the regulations thereunder (1) a pesticide not
registered with this Agency or (2) a
registered pesticide for a use not previously approved in the registration of
the pesticide may apply to the Administrator at any time for an experimental use permit.
(b) Pesticides under experimental use
permits may not be sold or distributed
other than through participants and, if
sold or distributed through participants, may be used only at an application site of a cooperator and in accordance with the terms and conditions of
the experimental use permit.
§ 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:

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Environmental Protection Agency

§ 172.3

(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 pur-

poses 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. 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
§ 172.4(b)(1)(ii) and (b)(1)(iii) and in the
case of an unregistered product, the information in § 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).

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§ 172.4

40 CFR Ch. I (7–1–13 Edition)

(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.

wreier-aviles on DSK5TPTVN1PROD with CFR

[59 FR 45611, Sept. 1, 1994, as amended at 71
FR 35546, June 21, 2006; 73 FR 75599, Dec. 12,
2008]

§ 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
(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
(ii) Submit a petition proposing establishment of a tolerance or an exemption from the requirement of a tolerance under section 408 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

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§ 172.7

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; 73 FR 75599, Dec. 12, 2008]

wreier-aviles on DSK5TPTVN1PROD with CFR

§ 172.5

The permit.

(a) Issuance. The Experimental Use
Permit shall be issued when the Administrator determines that the conditions of section 5 of the Act, and the
regulations thereunder, have been met
subject to such terms and conditions as
the Administrator determines are warranted.
(b) Duration. Permits will be effective
for a specified period of time, normally
one year, depending upon the crop or
site to be tested and the requirements
of the testing program submitted. The
applicant should propose a suitable duration of the permit commensurate
with the program submitted. Permits
and associated temporary tolerances
may be renewed, extended, or amended
upon request if circumstances warrant.
(c) Limitations. The quantity of a pesticide allowed by a permit may be less
than requested if it is determined that
the available information on efficacy,
toxicity or other hazards, the need for
data, or the adequacy of program supervision does not justify the quantity
of the pesticide requested. Other limitations may also be placed in the permit if necessary for the protection of
the public health and the environment.
(d) Additions. With respect to an experimental use pesticide containing
any chemical or combination of chemicals not included in any previously registered pesticides, the Administrator
may require that additional studies be
conducted during the permit period to
gather data to support the establishment of tolerances and/or registration.
To the extent practicable, the applicant will be notified of any such re-

quirements before or at the time an experimental use permit is issued.
(e) Maintenance of records. All producers of pesticides produced pursuant
to an experimental use permit shall
maintain records in accordance with
part 169.
§ 172.6

Labeling.

(a) Contents. Except as provided by
paragraph (b) of this section, all pesticides shipped or used under an experimental use permit shall be labeled with
directions and conditions for use which
shall include the following:
(1) The prominent statement, ‘‘For
Experimental Use Only’’;
(2) The Experimental Use Permit
number;
(3) The statement, ‘‘Not for sale to
any person other than a participant or
cooperator of the EPA-approved Experimental Use Program’’;
(4) The name, brand, or trademark;
(5) The name and address of the permittee, producer, or registrant;
(6) The net contents;
(7) An ingredient statement;
(8) Warning or caution statements;
(9) Any appropriate limitations on
entry of persons into treated areas;
(10) The establishment registration
number, except in those cases where
application of the pesticide is made
solely by the producer; and
(11) The directions for use, except
that the Administrator may approve
the use of the experimental program as
labeling provided that such program is
to be distributed with the product.
(b) Supplemental labeling. In the case
of a registered pesticide, the Administrator may, at his discretion, permit a
pesticide to be used under an experimental use permit with supplemental
labeling as approved by him.
§ 172.7 Importation of technical material.
Technical materials may be imported
without registration in sufficient quantities to formulate a pesticide for
which an Experimental Use Permit has
been requested if the application for
such permit states that such importation will occur.

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§ 172.8

40 CFR Ch. I (7–1–13 Edition)

§ 172.8 Program surveillance and reporting of data.
(a) The permittee shall supervise the
test program and evaluate the results
of testing at each site of application. It
will further be the responsibility of the
permittee to report immediately to the
Administrator, or to any person designated by him, any adverse effects
from use of, or exposure to, the pesticide.
(b) The permittee shall submit the
following reports to the Registration
Division during the experimental program.
(1) [Reserved]
(2) A final report shall be submitted
within 180 days after the expiration of
the permit, unless a request for extension of time is approved, and shall include:
(i) All data gathered during the testing program; field notes need not be
submitted but must be maintained and
submitted upon request;
(ii) A description of the disposition of
any pesticide containers and any unused pesticides including amounts disposed of and the method and site of disposition; and
(iii) The method of disposition of affected food and/or feed.
The data under paragraph (b)(2)(i) of
this section above may be submitted as
part of an application for registration
submitted within 180 days after the expiration of the permit, provided that
the final report shall include a statement that such application has been
made, and the date of such application.
(c) In addition to the reporting requirements provided for elsewhere in
this part, in the case of any meat-producing animals or birds that receive a
direct treatment or application of any
experimental use pesticide, the name
and location of the packing plant
where the animals will be processed
shall be sent to the U.S. Department of
Agriculture, Animal and Plant Health
Inspection Service, Washington, DC
20250, at least 10 days before the animals are to be shipped for slaughter.
This requirement may be waived, on
request, by the USDA. These provisions
do not exempt treated food-producing
animals and their products from compliance with other applicable inspection requirements.

(d) Failure to submit required reports
may constitute grounds for revocation
of the permit.
(e) For the purpose of supervising the
use of experimental use pesticides, the
Agency may require the permittee or
any participant to give reasonable advance notification of the intended
dates, times, and sites on which such
experimental use pesticide will be applied.
(f) The permittee or participants in
the experimental use program will permit any authorized representative of
the Agency, upon presentation of official identification, entry, at any reasonable time, to any premises involved
in the testing program to inspect and
to determine whether there has been
compliance with the terms and conditions of the permit.
[40 FR 18782, Apr. 30, 1975, as amended at 60
FR 32097, June 19, 1995]

§ 172.9 Renewals.
Applications for renewal of experimental use permits and temporary tolerances, to provide for additional testing, shall be submitted prior to expiration of the permit. Requirements for
renewals are the same as for applications under § 172.4, except that information previously submitted may be incorporated by reference.
§ 172.10 Refusals to issue and revocation.
(a) Refusal. At any time that the Administrator determines that an experimental use permit is not justified, or
that the issuance of such a permit
would cause unreasonable adverse effects on the environment, or that for
any other reason provided for under
the law a permit shall not be issued, he
shall notify the applicant in writing.
(b) Revocation. The Administrator
may revoke an experimental use permit if he finds that its terms or conditions are being violated or that its
terms or conditions are inadequate to
avoid unreasonable adverse effects on
the environment, or if new evidence is
obtained which demonstrates that the
tolerance will be inadequate to protect
the public health, or for failure to meet
any other provision of this part 172.
The Administrator will notify the permittee in writing of such revocation.

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§ 172.22

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The permittee shall notify all participants of such revocation as soon as
possible after he receives notice of revocation. The revocation of a permit
shall not preclude the Administrator
from initiating civil or criminal sanctions for the violations of the permit
conditions or otherwise as authorized
by law.
(c) Hearing. In the event that an applicant for an experimental use permit
wishes to contest the refusal to issue
an experimental use permit, or an experimental use permittee wishes to
contest the revocation of any such permit, he shall, within twenty days after
receipt of notice of such refusal or revocation, file with the Administrator a
written request for an opportunity to
confer with the Administrator or his
designee. Within twenty days after
such conference, the applicant or permittee will be notified of the Administrator’s final decision.
§ 172.11 Publication.
(a) Notice of receipt of an experimental
use permit application. The Administrator shall publish notice in the FEDERAL REGISTER of receipt of an application for an experimental use permit
upon finding that issuance of the experimental use permit may be of regional or national significance. This
notice shall include:
(1) The active ingredients,
(2) Use pattern(s),
(3) Quantity of pesticide,
(4) Total acreage,
(5) Location of area of application,
(6) A statement soliciting comments
from any interested persons regarding
the application.
(b) Public hearing. The Administrator
may hold a public hearing, and publish
notice in the FEDERAL REGISTER of the
date and location of the hearing, when
he determines that there is sufficient
interest in the application to warrant a
hearing, based upon the comments received in response to the Notice of Receipt of an Application, or that a hearing would otherwise be in the public interest.
(c) Issuance of experimental use permit.
The Administrator shall give prompt
notice in the FEDERAL REGISTER of the
issuance of an experimental use permit. The notice shall include:

(1) The active ingredients,
(2) Use pattern(s),
(3) Quantity of pesticide,
(4) Total acreage,
(5) Location of area of application,
(6) A statement indicating where the
experimental use permit is available
for public inspection.

Subpart B—State Issuance of
Experimental Use Permits
SOURCE: 44 FR 41787, July 18, 1979, unless
otherwise noted.

§ 172.20 Scope.
This subpart sets forth regulations
governing State issuance of experimental use permits pursuant to section
5(f) of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA). It also sets forth regulations governing authorization by the
Administrator of State experimental
use permit programs.
§ 172.21 Definitions.
Terms used in this subpart shall have
the meaning set forth in FIFRA and in
§ 172.1.
Designated State agency means the
State agency designated by State law
or other authority to be responsible for
registering pesticides to meet special
local needs.
Public or private agricultural research
agency or educational institution means
any organization engaged in research
pertaining to the agricultural use of
pesticides, or any educational institution engaged in pesticide research. Any
research agency or educational institution whose principal function is to promote, or whose principal source of income is directly derived from, the sale
or distribution of pesticides (or their
active ingredients) does not come within the meaning of this term.
[73 FR 75599, Dec. 12, 2008]

§ 172.22 General.
(a) Experimental use permits are not
required under this rule in those situations described in § 172.3 of subpart A
pertaining to Federal experimental use
permits.
(b) Subpart B is not applicable to experimental use permits issued by a

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§ 172.23

40 CFR Ch. I (7–1–13 Edition)

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State, as required by State law, to a
permittee who already holds a valid
Federal experimental use permit issued
under subpart A for the same purpose,
or who is not required to obtain a permit under this rule.
(c) Pesticide products used under experimental use permits may not be sold
or distributed other than through participants, and, if sold or distributed
through participants, may be used only
at an application site of a cooperator
and in accordance with the terms and
conditions of the experimental use permit.
(d) Establishments in which pesticide
products under State experimental use
permits are produced shall be registered as required by 40 CFR 167.2(a)
and producers of such products shall
maintain books and records as required
by 40 CFR 169.2.
(e) Pesticide products and their containers used under this rule must also
be packaged, stored, transported, used,
and disposed of in accordance with all
applicable Federal laws and regulations, including the Resource Conservation and Recovery Act of 1976 as
amended (Pub. L. 94–580; 90 Stat. 2795;
42 U.S.C. 6901 et seq.) (RCRA), and rules
thereunder.
§ 172.23 State plans.
(a) Submission. (1) A State may, by
submitting a State plan, request the
Administrator to authorize the designated State agency to issue experimental use permits under section 5(f)
of FIFRA.
(2) A State shall request authorization to issue experimental use permits
by having the Governor or Chief Executive Officer or his designated agent
submit a State plan in writing to the
Administrator.
(b) Contents. A State plan shall include—
(1) A designation of the State agency
responsible for the administration of
the State experimental use permit program.
(2) An opinion of the State attorney
general or the legal counsel of the designated State agency that the State
has the requisite legal authorities as
set forth in paragraph (c)(1)(i) of this
section, accompanied by copies of the
applicable State laws and regulations.

(3) A description of procedures that
the designated State agency will follow:
(i) To review experimental use permit applications, to ensure that experimental use permits will be issued in accordance with the terms and conditions
of the authorization, FIFRA, and this
subpart; and
(ii) To supervise use pursuant to the
permits, and to ensure that permits are
used in accordance with their terms
and conditions, FIFRA, and this subpart.
(c) Criteria for EPA acceptance of State
plan. (1) The Administrator shall grant
authorization to issue experimental
use permits if the State plan establishes that the designated State agency—
(i) Has adequate legal authority
under State law to implement the plan,
including authority:
(A) To issue experimental use permits, subject to limitations necessary
for the protection of public health and
the environment;
(B) To supervise the use of a pesticide
pursuant to an experimental use permit, as provided in § 172.25(c);
(C) To deny an experimental use permit if it determines that a permit is
not justified, or that the issuance of
the permit would cause unreasonable
adverse effects on the environment;
(D) To amend or revoke an experimental use permit, if the designated
State agency finds that:
(1) The terms and conditions of the
permit are being violated, or are inadequate to avoid unreasonable adverse
effects on the environment;
(2) Any required tolerance under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301 et seq.) has been revoked
by EPA, or any exemption from the requirement for tolerance has been withdrawn by EPA; or
(3) A failure by the permittee or any
cooperator to meet any other provision
of FIFRA or this subpart has occurred;
(E) To enter, by consent or by warrant or by other legal means, in connection with an experimental use permit, a permittee’s or cooperator’s
premises at reasonable times in order
to sample or inspect any pesticides
used or property treated, to inspect
any equipment or records kept, or to

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§ 172.24

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observe any activities conducted, as
necessary to enforce compliance with
State law, the terms of the permit, and
this subpart;
(F) To comply in all other respects
with the requirements of this subpart,
including labeling requirements; and
(ii) Utilizes procedures for the review
of each permit which are adequate to
ensure that the State program will be
administered in accordance with the
purposes of FIFRA and this subpart.
(2) After receiving a State plan, EPA
shall publish a FEDERAL REGISTER notice announcing the fact and inviting
interested parties to comment thereon.
(d) Approval, rejection, and revocation.
(1) EPA shall approve or reject the
State plan within 90 days after receipt
of all information necessary for final
review of the plan, including copies of
effective statutes and regulations
which satisfy the requirements of this
subpart.
(2) The Administrator may at any
time revoke the authorization of a
State to issue experimental use permits if he determines that the designated State agency has not complied
with the requirements of this subpart
or with the terms and conditions of
such authorization. State experimental
use permits issued prior to the revocation of authority shall remain valid
until they expire or until three years
from the date of revocation of the
State’s authority, whichever comes
first, unless sooner revoked by EPA
under § 172.26(c) of this subpart.
(3) Notices of approval, rejection, and
revocation shall be published in the
FEDERAL REGISTER, as well as the basis
for such approval, rejection, or revocation.
(4) Prior to rejecting or revoking authorization, the Administrator shall
notify the State in writing of his intention to take such action, along with
the basis for such action, and shall afford the State the opportunity for a
hearing, and time to take corrective
action.
§ 172.24 State issuance of permits.
(a) General. Upon approval of a State
plan by the Administrator under
§ 172.23, the designated State agency is
authorized to issue, amend, renew,
deny or revoke experimental use per-

mits subject to the terms of the authorization and these regulations.
(b) Authority. A designated State
agency may issue an experimental use
permit—
(1) To any person for the purpose of
gathering the data necessary to support the State registration of a pesticide to meet special local needs under
section 24(c), FIFRA.
(2) To any agricultural research
agency or educational institution conducting work within the State for the
purpose of experimentation:
(i) Which is done within the State;
and
(ii) Which is not directly intended to
result in the registration of a specific
pesticide product.
(3) For use of a restricted use pesticide only if the pesticide is to be used
by, or under the direct supervision of,
an applicator certified in accordance
with section 11 of FIFRA.
(c) Limitations. (1) In the case of applicants who need to gather data required to register a pesticide product
to meet a special local need under section 24(c) of FIFRA, a State may only
issue experimental use permits for the
types of pesticide products and uses
which it has authority to register
under section 24(c).
(2) A State may not issue an experimental use permit under § 172.24(b)(1) or
§ 172.24(b)(2) for any of the following:
(i) A product containing an active or
inert ingredient not contained in any
EPA-registered product;
(ii) A product containing an active or
inert ingredient which is currently subject to an EPA cancellation or suspension of registration order, or which is
currently subject to an EPA notice of
intent to suspend or cancel registration because of human health, environmental or efficacy considerations; except that the State may issue a permit
for such a product for a purpose or in a
formulation—
(A) Which was not specifically considered in, or which is not subject to,
such suspension or cancellation proceedings, after consultation with appropriate EPA officials; or
(B) Which was specifically considered
during such proceedings but not suspended, cancelled, or subjected to a notice of intent to suspend or cancel;

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§ 172.25

40 CFR Ch. I (7–1–13 Edition)

(iii) A use of a product which has
been the subject of a notice of denial of
registration published in the FEDERAL
REGISTER pursuant to section 3(c)(6) of
FIFRA and part 154 of this chapter; or
(iv) A use of a product which may involve use in or on food or feed other
than as authorized under § 172.24(d), Requirement of tolerance.
(3) A State may not issue an experimental use permit for use of a pesticide
product in an area or in an amount in
excess of that necessary to accomplish
the purposes for which the permit was
issued under paragraph (b) of this section.
(d) Requirement of tolerance. If the experimental use pesticide is to be used
in or on food or feed, the applicant
must—
(1) Submit evidence that:
(i) 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; and
(ii) The proposed program would not
reasonably be expected to result in residues of the pesticide in or on such food
or feed in excess of that authorized
under section 408 of the Federal Food,
Drug and Cosmetic Act; and
(iii) All inert ingredients in the pesticide are exempted from the requirement of a tolerance under the appropriate section of 40 CFR part 180, subpart D; or
(2) 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 destruction
or disposal shall be described in the application for the permit.
[44 FR 41787, July 18, 1979, as amended at 50
FR 49020, Nov. 27, 1985; 73 FR 75599, Dec. 12,
2008]

wreier-aviles on DSK5TPTVN1PROD with CFR

§ 172.25 Administration of State programs.
(a) General. State experimental use
permit programs shall be consistent
with the Federal experimental use permit program, as set forth in subpart A
of 40 CFR part 172.

(b) Procedures leading to issuance. An
application for an experimental use
permit shall be made in writing, and
shall contain sufficient information,
including a confidential statement of
formula for any new product, to enable
the State to determine whether use
pursuant to the permit would be in accordance with the purposes of FIFRA
and this subpart.
(c) Labeling. (1) New products shall
bear labeling satisfying the requirements of § 172.6(a), except that the
prominent statement ‘‘For Distribution and Experimental Use Only Within
(State)’’ shall be used in place of ‘‘For
Experimental Use Only’’. The designated State agency may approve, as
directions for use on labeling, the experimental program, provided such program is to be distributed with the product.
(2) The designated State agency may
permit an EPA or State registered pesticide to be used under an experimental
use permit with supplemental labeling
as approved by the State agency. In exercising this discretion, the designated
State agency shall ensure that the supplemental labeling and the registered
label together satisfy the requirements
of § 172.6(a).
(d) Duration. State experimental use
permits shall be issued for a specified
period of time, not to exceed three
years, depending upon the nature of
the pest problem and the requirements
of the testing program submitted. The
designated State agency may renew,
extend or amend the stated duration of
a permit, if circumstances warrant.
(e) Limitations. The designated State
agency shall impose such limitations
in the permit as are necessary to protect health and the environment, including limitations on quantity, sites,
area, disposal, and other aspects of pesticide use.
(f) Program surveillance and reporting
of data. (1) The permittee shall supervise the test program and evaluate the
results of testing at each site of application. The designated State agency
shall require the permittee to report to
it immediately any adverse effects resulting from use of, or exposure to, the
pesticide.

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§ 172.26

(2) During the course of the program,
the designated State agency shall require the permittee to submit such reports (both special and periodic) as are
necessary to supervise effectively the
progress of the program to prevent unreasonable adverse effects on man or
the environment. The designated State
agency shall also require the permittee
to submit a final report at the conclusion of the program. Where applicable,
such reports shall also be made available to the U.S. Department of Agriculture, Food Service and Quality
Service
(FSQS),
as
required
by
§ 172.8(c).
(g) Disposal. All pesticides and pesticide containers, whether disposed of
during the course of a State permit or
remaining at the termination of a permit, must either be:
(1) Disposed of in accordance with a
disposal plan approved as part of the
experimental program; or
(2) Returned to the permittee for
storage or disposal in accordance with
the requirements of RCRA and rules
there under; or
(3) If the product is currently registered, used in accordance with the
registered label.

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[44 FR 41787, July 18, 1979, as amended at 60
FR 32097, June 19, 1995]

§ 172.26 EPA review of permits.
(a) Notification of State action. (1)
Within 10 days after the issuance of an
experimental use permit, the designated State agency shall notifiy EPA
of the action by forwarding to the appropriate EPA Regional Office a copy
of the permit, a description of the experimental program to be conducted
under the terms of the permit, a copy
of the approved labeling, and a copy of
the confidential statement of formula
for any new product.
(2) Within 10 days after amendment
or revocation of an experimental use
permit by a State, the designated State
agency shall notify the appropriate
EPA Regional Office in writing of the
amendment or revocation. The notice
shall include a brief explanation of the
reason for the amendment or revocation. If amendments to permits include
changes in the approved labeling, the
designated State agency shall also forward a copy of the amended labeling.

(3) EPA shall give notice in the FEDREGISTER of State issuance of experimental use permits.
(b) Reports. The designated State
agency shall submit the following reports to EPA:
(1) An annual report covering the
number of permits issued, the names
and addresses of permittees, the names
of the products covered by permits, and
the State permit numbers issued;
(2) Reports, as requested by EPA,
containing any information that EPA
may determine necessary to ensure
that a State has acted in compliance
with provisions of FIFRA and this subpart; and
(3) Reports of any serious adverse effect(s), as soon thereafter as possible,
from use of, or exposure to, a pesticide
used pursuant to an experimental use
permit.
(c) Revocation by EPA. (1) The Administrator may revoke an experimental
use permit issued under this subpart if
he finds:
(i) That its terms and conditions are
being violated;
(ii) That its terms and conditions are
inadequate to avoid unreasonable adverse effects on the environment;
(iii) That new evidence demonstrates
that any tolerance upon which the permit is based will be inadequate to protect the public health, or that any exemption from the requirement for a
tolerance is no longer appropriate; or
(iv) That a failure by the permittee
to meet any other provisions of FIFRA
or this subpart has occurred.
(2) The Administrator shall, prior to
revoking a State experimental use permit, consult with the State agency
which issued the permit, except in
cases where continued use of the pesticide under the permit would create
an imminent hazard to man or the environment.
(3) The Administrator shall notify
the designated State agency, in writing, of the revocation, and the State
agency shall notify the permittee, also
in writing, of the revocation.
(4) The permittee shall notify all participants of the revocation within 10
days after he receives notice of revocation.
(5) The revocation of a permit shall
not preclude the Administrator from
ERAL

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40 CFR Ch. I (7–1–13 Edition)

initiating civil or criminal sanctions
for violations of the permit conditions
or other violations, as authorized by
law.
(6) If a permittee wishes to contest
the revocation of a State experimental
use permit, he shall, within 30 days
after receipt of notice of such revocation, file with the Administrator a
written request for an opportunity to
confer with the Administrator or his
designee. The revocation of the permit
shall remain effective pending the outcome of any conference requested
under this paragraph.
(7) If a permittee requests a conference under paragraph (c)(6) of this
section, the Administrator shall provide the permittee:
(i) With information as to the time,
place and nature of the conference, and
of the matters of fact and law asserted
by the Agency as grounds for the revocation action;
(ii) An opportunity to offer a written
statement of facts, explanations, and
arguments relevant to the revocation
action;
(iii) All other procedural opportunities to which the permittee may be entitled by law.
(8) The Administrator shall notify
the affected permittee and State Agency, in writing, of his final decision on
the revocation matter as expeditiously
as possible and shall attempt to do so
within 30 days after the conclusion of a
conference conducted under paragraph
(c)(7). The Administrator shall also
provide the permittee and the State
agency with a written statement of the
reasons for his decision, which shall
take into account the evidence presented pursuant to paragraph (c)(7)(ii)
of this section.
(9) A decision to revoke a permit
under paragraph (c)(8) of this section is
a final Agency action subject to judicial review as provided by law.

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[44 FR 41787, July 18, 1979, as amended at 73
FR 75599, Dec. 12, 2008]

Subpart C—Notification for Certain
Genetically Modified Microbial Pesticides
SOURCE: 59 FR 45612, Sept. 1, 1994, unless
otherwise noted.

§ 172.43

Definitions.

Terms used in this subpart shall,
with the exception of those defined
below, have the meaning set forth in
the Act and in § 172.1.
Containment and inactivation controls
means any combination of mechanical,
procedural, or biological controls designed and operated to restrict environmental release of viable microorganisms from a facility.
Deliberately modified means the directed addition, rearrangement, or removal of nucleotide sequences to or
from genetic material.
Introduction of genetic material means
the movement of nucleotide sequences
into a microorganism, regardless of the
technique used.
Inversions of genetic material means
the replacement of an internal section
of a chromosome in the reverse orientation.
Microbial pesticide means a microbial
agent intended for preventing, destroying, repelling, or mitigating any pest,
or intended for use as a plant regulator, defoliant, or desiccant, that:
(1) Is a eucaryotic microorganism including, but not limited to, protozoa,
algae and fungi;
(2) Is a procaryotic microorganism,
including,
but
not
limited
to,
Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including, but not
limited to, viruses.
Microbial pesticides resulting from rearrangements means a microbial pesticide resulting from translocations or
inversions of genetic material.
Microorganism means a bacterium,
fungus, alga, virus, or protozoan.
Nonindigenous
microbial
pesticide
means a microbial pesticide brought
into one of the following geographic
areas from outside that area:
(1) The continental United States, including Alaska, and the immediately
adjoining countries (i.e., Canada and
Mexico).
(2) The Hawaiian Islands.
(3) The Caribbean Islands including
Puerto Rico and the U.S. Virgin Islands.

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§ 172.45

Pesticidal property means a characteristic exhibited by a microorganism that contributes to the intentional use of the microorganism to prevent, destroy, repel, or mitigate a pest
or to act as a plant regulator, defoliant, or desiccant.
Single genome means the sum total of
chromosomal and extrachromosomal
genetic material of an isolate and any
descendants derived under axenic culture conditions from that isolate.
Small-scale test means the experimental use of a microbial pesticide in a
facility such as a laboratory or greenhouse, or use in limited replicated field
trials or other tests as described in
§ 172.3(c).
Test or testing means any use of a microbial pesticide consistent with section 5 of the Act, including limited replicated field trials and associated activities.
Translocations of genetic material
means a chromosomal configuration in
which part of a chromosome becomes
attached to a different chromosome, or
inserts in a different location on the
same chromosome.

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[59 FR 45612, Sept. 1, 1994, as amended at 72
FR 61029, Oct. 26, 2007]

§ 172.45 Requirement for a notification.
(a) Who must submit a Notification.
Notwithstanding § 172.3, any person
who plans to conduct small-scale testing of a type of microbial pesticide
identified in paragraph (c) of this section must submit a Notification to
EPA and obtain prior approval for either of the following tests:
(1) Small-scale tests that involve an
intentional environmental introduction of that microbial pesticide.
(2) Small-scale tests performed in a
facility without adequate containment
and inactivation controls as provided
in paragraph (e) of this section.
(b) Alternative to Notification. In lieu
of a Notification, any person required
to submit a Notification under paragraph (a) of this section may submit an
application for an experimental use
permit (EUP) to EPA for approval.
(c) Small-scale testing that requires a
Notification. As provided in paragraph
(a) of this section, and notwithstanding
any other approval by any govern-

mental entity, EPA review and approval are required prior to the initiation of any small-scale test involving
either of the following microbial pesticides:
(1) Microbial pesticides whose pesticidal properties have been imparted
or enhanced by the introduction of genetic material that has been deliberately modified.
(2) Nonindigenous microbial pesticides that have not been acted upon
by the U.S. Department of Agriculture
(i.e., either by issuing or denying a permit or determining that a permit is unnecessary; or a permit is not pending
with the USDA).
(d) Small-scale testing that does not require a Notification. (1) Testing conducted with microbial pesticides identified in paragraph (c) of this section,
but made exempt pursuant to § 172.52,
does not require a Notification. The
following microbial pesticides (or
classes of pesticides) are exempt from
the notification requirement in paragraph (a) of this section:
(i) Microbial pesticides resulting
from deletions or rearrangements within a single genome that are brought
about by the introduction of genetic
material that has been deliberately
modified.
(ii) [Reserved]
(2) Testing conducted in a facility
with adequate containment and inactivation controls, as provided in paragraph (e) of this section, does not require a Notification.
(e) Selection and use of containment
and inactivation controls. (1) Selection
and use of containment and inactivation controls for a particular microbial
pesticide shall take into account the
following:
(i) Factors relevant to the microbial
pesticide’s ability to survive in the environment.
(ii) Potential routes of release in air,
solids, and liquids; in or on waste materials and equipment; in or on people
(including maintenance and custodial
personnel); and in or on other organisms such as insects and rodents.
(iii) Procedures for transfer of materials between facilities.
(iv) Plans for routine or emergency
clean-up and test termination.

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40 CFR Ch. I (7–1–13 Edition)

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(2) For purposes of paragraph (e)(1) of
this section, EPA will presume that
compliance with the containment provisions of the National Institutes of
Health (NIH) ‘‘Guidelines for Research
Involving Recombinant DNA Molecules’’ (51 FR 16958, May 7, 1986) constitutes selection and use of adequate
containment and inactivation controls.
(3) The selection of containment and
inactivation controls shall be approved
by an authorized official of the organization that is conducting the test prior
to commencement of the test.
(4) Records shall be developed and
maintained describing the selection
and use of the containment and inactivation controls, including contingency plans for emergency clean-up
and test termination, that will be used
during the test. These records shall be
available for inspection at the test facility. In addition, these records shall
be submitted to EPA at EPA’s request
and within the time frame specified in
EPA’s request.
(5) Subsequent to any EPA review of
the containment/inactivation controls
selected under paragraph (e)(1) of this
section, changes to the controls necessary to prevent unreasonable adverse
effects must be made upon EPA request. Failure to comply with EPA’s
request shall result in automatic revocation of the exemption from the requirement to submit a Notification.
§ 172.46 Submission of a notification.
(a) When to submit a Notification. A
Notification shall be submitted for approval at least 90 days prior to the initiation of the proposed test.
(b) Where to submit a notification. A
notification shall be submitted to the
Office of Pesticide Programs’ Document Processing Desk at the appropriate address as set forth in 40 CFR
150.17(a)
or
(b),
Attention:
Biotechnology Notification Review.
(c) How to format a Notification. A Notification submitted under this section
must comply with the following procedures, but is not required to comply
with the format and other provisions
governing submission of data in
§§ 158.32 and 158.33 or §§ 161.32 and 161.33
of this chapter. However, because data
submitted with the Notification may
subsequently be used to support other

regulatory actions (e.g., used in EUP or
registration applications), it is recommended that such data comply with
EPA requirements in §§ 158.32 and 158.33
of this chapter.
(1) Each Notification must be accompanied by a transmittal document that
clearly identifies the EPA action supported as a Biotechnology Notification
Review.
(2) Five copies of each Notification
must be submitted to EPA.
(3) Any claims of confidentiality for
information submitted in the Notification must be made as described in paragraph (d) of this section.
(d) How to make confidential business
information (CBI) claims in a Notification. Although it is strongly recommended that the submitter minimize the amount of data and other information claimed as CBI, a submitter
may assert a claim of confidentiality
for all or part of the information submitted to EPA in a Notification (See
part 2, subpart B of this chapter). To
assert such a claim, the submitter
must comply with the following procedures:
(1) Any claim of confidentiality must
accompany the information at the time
the information is submitted to EPA.
Failure to assert a claim at that time
will be considered a waiver of confidentiality for the information submitted,
and the information may be made
available to the public, subject to section 10(g) of the Act, with no further
notice to the submitter.
(2) Of the five copies of the Notification required by paragraph (c) of this
section, four copies must be complete
with the information that is claimed
confidential clearly marked in the
manner described in § 2.203(b) of this
chapter. All information claimed as
confidential must be deleted from the
fifth copy, but it must be otherwise
complete. The first page of the fifth
copy must be marked ‘‘Contains no information claimed as confidential.’’
EPA may include the fifth copy in a
public file without further notice. EPA
will consider incomplete a Notification
containing information claimed as CBI
that is not submitted in accordance
with this paragraph and will suspend
the review period on the Notification
until such procedures are followed.

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§ 172.48

(3) Any claim of confidentiality must
be accompanied, at the time the claim
is made, by comments substantiating
the claim and explaining why the submitter believes that the information
should not be disclosed. The submitter
should refer to § 2.204(e)(4) of this chapter for points to address in the substantiation. If such comments are themselves claimed confidential and are
marked confidential when submitted to
EPA, they will be treated as such in accordance with § 2.205(c) of this chapter.
EPA will consider incomplete all Notifications
containing
information
claimed as CBI that are not accompanied by substantiation, and will suspend the review period on such Notifications until the required substantiation is provided.
(4) EPA will disclose information
that is subject to a claim of confidentiality asserted under this section only
to the extent and by means of the procedures set forth in section 10 of the
Act, in this subpart, and in part 2 of
this chapter.

wreier-aviles on DSK5TPTVN1PROD with CFR

[59 FR 45612, Sept. 1, 1994, as amended at 71
FR 35546, June 21, 2006; 72 FR 61029, Oct. 26,
2007; 73 FR 75600, Dec. 12, 2008]

§ 172.48 Data requirements for a notification.
This section identifies the data and
information to be included in each Notification. When specific information is
not submitted, an explanation of why
it is not practical or necessary to provide the information is to be provided.
(a) The identity of the microorganism which constitutes the microbial
pesticide including:
(1) Summary of data supporting the
taxonomic designation and its interpretation.
(2) Means and limit of detection
using sensitive and specific methods
(e.g., note the use of any markers that
are used to distinguish the introduced
population from native microorganisms). Introduction into the microbial
pesticide of a unique genetic marker is
encouraged.
(b) Description of the natural habitat
of the parental strain of the microbial
pesticide including information on:
(1) Physical and chemical features
important to growth and survival of
the parental strain.

(2) Biological features of the parental
strain that would have an impact on
the microbial pesticide (e.g., presence
of phages that infect the microorganism).
(3) Competitors.
(c) Information on the host range of
the microbial pesticide, if any, with an
assessment of infectivity and pathogenicity to nontarget organisms.
(d) Information on survival and the
ability of the microbial pesticide to increase in numbers (biomass) in the environment (e.g., in the environment
into which the microbial pesticide will
be introduced, and in substantially different environments that may be in the
immediate vicinity). These data may
be derived from the scientific literature or from tests conducted in a
laboratory or other containment facility.
(e) The identity of possible transmission vectors (e.g., insects).
(f) Data on relative environmental
competitiveness compared to the parental strain of the microbial pesticide.
(g) Description of the methods used
to genetically modify the microbial
pesticide.
(h) The identity and location of the
gene segments that have been rearranged or inserted/deleted (host source,
nature, and, for example, base sequence
data, or restriction enzyme map of the
genes).
(i) Information on the control region
of the genes, and a description of the
new traits or characteristics that are
expressed.
(j) Data on potential for genetic
transfer and exchange with other organisms and on genetic stability of any
inserted sequences in the microbial
pesticide.
(k) A description of the proposed
testing program including:
(1) The purpose or objectives of the
proposed testing.
(2) Designation of the pest organisms
involved
(common
and
scientific
names).
(3) The States in which the proposed
program will be conducted.
(4) The exact location of the test
sites (including proximity to residences and human activities, surface
water, etc.).

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§ 172.50

40 CFR Ch. I (7–1–13 Edition)

(5) The crops, fauna, flora, geographical description of sites, modes,
dosage rates, frequency, and situation
of application on or in which the pesticide is to be used.
(6) The total amount of pesticide
product proposed for use in the testing.
(7) The method of application.
(8) A comparison of the natural habitat of the microbial pesticide with the
proposed test site.
(9) The number of acres, structural
sites, or animals/plants by State, to be
treated or included in the area of experimental use.
(10) Procedures to be used to protect
the test area from intrusion by unauthorized individuals.
(11) The proposed dates or periods
during which the testing program is to
be conducted, and the manner in which
supervision of the program will be accomplished.
(12) Description of procedures for
monitoring the microbial pesticide
within and adjacent to the test site
during the test.
(13) The method of sanitation or disposal of plants, animals, soils, farm
tools, machinery etc., that will be exposed to the microbial pesticide during
or after the test.
(14) Means of evaluating potential adverse effects and methods of controlling the microbial pesticide if detected
beyond the test area.
(l) A statement of composition for
the formulation to be tested, giving:
(1) The name and percentage by
weight (or other suitable units) of each
ingredient, active and inert.
(2) Production methods.
(3)
Extraneous
microorganisms
present as contaminants.
(4) Amount and potency of any toxin
present.
(5) Where applicable, the number of
viable microorganisms per unit weight
or volume of the product or other appropriate system for designating the
quantity of active ingredient.
(m) Any additional factual information regarding the potential for unreasonable adverse effects on the environment.
§ 172.50 Response to a notification.
(a) EPA will review and evaluate
each Notification as expeditiously as

possible and will make a determination
no later than 90 days after receipt of
the complete Notification; however,
under no circumstances shall the proposed test proceed until the submitter
has received notice from EPA of its approval of such test.
(b) For each Notification, EPA may
make the following determinations:
(1) Require additional information
from the submitter to assess the proposed test adequately.
(2) Approve the proposed test.
(3) Approve the proposed test provided that the submitter makes certain
modifications to the test proposal.
(4) Require an EUP for the test.
(5) Disapprove the proposed test because of the potential for unreasonable
adverse effects. Such disapproval by
EPA shall be considered the equivalent
of denial of an EUP and the remedies
for such denial provided by § 172.10 are
available to the submitter.
(c) If the proposed test is approved by
EPA, then the submitter shall perform
the test in the same manner described
in the Notification, subject to any requirements imposed under paragraph
(b)(3) of this section.
§ 172.52 Notification exemption process.
(a) Initiation of the exemption process.
Pesticides may be added to the list of
exemptions in § 172.45(d) by rule at
EPA’s initiative or in response to a petition submitted in accordance with
paragraph (b) of this section.
(b) Petitions for exemption from the requirement for a Notification—(1) Who
may submit a petition. Any person may
submit a petition requesting an exemption from the notification requirements of this subpart for a specific microbial pesticide or class of microbial
pesticides.
(2) Where to submit a petition. All petitions shall be submitted to the Office
of Pesticide Programs’ Document Processing Desk at the appropriate address
as set forth in 40 CFR 150.17(a) or (b).
(3) Content of petition. Each petition
shall contain the following:
(i) Name and address of petitioner
and name, address, and telephone number of a person who may be contacted
for further information.

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Environmental Protection Agency

§ 172.59

(ii) Description of the exemption requested, including the specific microbial pesticide or class of microbial pesticides to be tested under the petition
for exemption.
(iii) Basis for the petitioner’s contention that the specific microbial pesticide or class of microbial pesticides
meet the criteria of § 172.3 for smallscale tests of pesticides that do not require an EUP.
(iv) Discussion of the extent to which
the microbial pesticide or class of microbial pesticides covered by the petition differ from microbial pesticides
that are already registered or subject
to an EUP under the Act.
(4) Administrative action on a petition.
EPA will review and evaluate petitions
as expeditiously as possible and may
request further information from the
petitioner to assess the proposed exemption adequately. No later than 180
days after the submission of a petition,
or 90 days after the last submission of
additional information by the petitioner, whichever is later, EPA will
take one of the following actions with
respect to the petition:
(i) Grant the petition and publish a
notice of proposed rulemaking in the
FEDERAL REGISTER for a 45–day comment period proposing the exemption
requested by the petitioner.
(ii) Grant the petition and publish a
notice of proposed rulemaking in the
FEDERAL REGISTER for a 45–day comment period proposing an exemption
under such terms and conditions as
EPA deems appropriate.
(iii) Deny the petition and provide
the petitioner with a written explanation of EPA’s decision.
(5) Confidential business information
(CBI) claims. To assert a claim of confidentiality, the petitioner must comply with the applicable procedures in
§ 172.46(d).
(6) Supplements, amendments, and
withdrawals. The petitioner may supplement, amend, or withdraw his or her
petition in writing without EPA approval at any time prior to the granting or denial of the petition under
paragraph (b)(4) of this section. The
withdrawal of a petition shall be with-

out prejudice to the resubmission of
the petition at a later date.
[59 FR 45612, Sept. 1, 1994, as amended at 71
FR 35546, June 21, 2006]

§ 172.57 Submission of information regarding potential unreasonable adverse effects.
Any person using a microbial pesticide in small-scale testing covered by
this subpart who obtains information
regarding potential unreasonable adverse effects on health or the environment must within 30 days of receipt of
such information submit the information to EPA, unless the person has actual knowledge that EPA has been adequately informed of such information.
The requirement to submit information applies both to those microbial
pesticides subject to the notification
requirements under § 172.45(c) and those
that are exempt under § 172.45(d).
§ 172.59

Enforcement.

(a) Imminent threat of substantial harm
to health or the environment. The use of
a microbial pesticide in small-scale
testing covered by this subpart (whether subject to the notification requirements of § 172.45(c) or exempt under
§ 172.45(d)) in a manner that creates an
imminent threat of substantial harm
to health or the environment is prohibited, and is considered a violation of
section 12(a)(2)(S) of the Act.
(b) EPA response to violations. Under
section 14 of the Act, EPA may seek
civil or criminal penalties for violations of the Act. Failure to comply
with the regulations in this part could
result in civil or criminal penalties.
Moreover, under sections 14 and 16(c) of
the Act, EPA may at any time take appropriate action against violators to
prevent or otherwise restrain use of a
microbial pesticide in small-scale testing if it is determined that:
(1) Such use would create an imminent threat of substantial harm to
health or the environment that is prohibited under paragraph (a) of this section; or
(2) The terms or conditions on which
approval of the testing was granted
under this subpart C are violated.

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