PB83-153932
Pesticide Assessment Guidelines
Subdivision I: Experimental Use Permits
(U.S.) Environmental Protection Agency
Washington, DC
Oct 82
U.S. DEPARTMENT OF COMMERCE
National Technical Information Service
NTTS
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EPA 540/9-82-022
October, 1982
PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION I
EXPERIMENTAL USE PERMITS
by
Donald R. Stubbs
Registration Division
Office of Pesticide Programs
Guidelines Projects Managers
Robert K. Hitch
Hazard Evaluation Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
Office of Pesticides and Toxic Substances
Washington, D.C. 20460
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FREPORT DOCUMENTATION '....Kr.*w NO.
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Subdivision I - Experimental Use Permits
7. AuthOr(S!
i Donald R. Stubbs
9. Performing Or2ani:3tion N»r"e «nd Address
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
12. Sponsoring GrKjmrjtiori Nime and Address
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
15. SuDpi«men£jr> Hates
Guidelines Project Manager: Robert K. Hitch
Ifi. ABStMCt (Limit: 200 word)
October, 1982
10. P'r)|«c!/TaiV/Wor« Uni( ,-;o.
11. ConlrjctCC) or Cr.in:(G; :.').
(C!
(G)
13. Type of Resort /. Period Covered
As a guideline for the Federal Insecticide Fungicide and Rodenticide
Act (FIFRA), Subdivision I describes Experimental Use Permit Application
procedures. The reader will find formatting instructions for these appli-
cations and descriptions of the types of studies which can be conducted
under a permit. Discussions of the data required to support Experimental
Use Permit applications are also presented as a foundation for the
regulatory pesticide data requirements (40 CFR Part 158).
Subdivision I constitutes one volume of a twelve-part FIFRA guideline
series published by the National Technical Information Service.
17. Document Analysis a. Descriptors
;•-. Id«nti/ien/O^en-F.nded lerrm
C. COSATI r^lcl.'O.rouo
13. Availibiltty Statement
| 19. Security Class U>i-
!
I ____ .
.' SO. Security Clasi (Ih'i
O''T;iJf,'»L 'OIIU
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Foreword
Subdivision I describes procedures for applying for, and testing under,
the Experimental Use Permits required by the Federal Insecticide, Fungicide
and Rodenticide Act (FIFRA). It is a non-regulatory companion to 40 CFR
Part 158, Data Requirements for Registration. Public comment on Subdivi-
sion I has been taken in a series of public meetings the last of which
was held in July 1982. Data requirements established by 40 CFR Part 158
are discussed in Subdivision I so that it can be read as a complete
package and so that Experimental Use Permit application and testing
procedures can be explained in their proper context.
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SUBDIVISION I - EXPERIMENTAL USE PERMITS
TABLE OF CONTENTS »
DISCUSSION
I. Organization and Philosophy 1
II. -Issues Concerning Subdivision I Guidelines 7
GUIDELINES
Series 110: GENERAL
110-1 Scope and Intent 15
110-2 Definitions 16
110-3 Pesticide Uses for Which an Experimental
Permit is Required . 17
110-4 Instructions, Labeling, and Limitations for
Pesticides not Requiring a Permit 19
110-5 Experimental Use Permits for Pesticides Under
Intensive Review of Risks and Benefits, and
Cancelled or Suspended Pesticides 20
Series 111: PROCEDURES
111-1 General Requirements 22
111-2 Labeling 25
111-3 Experimental Program 29
111-4 Permit 32
111-5 Importation of Pesticides for Experimental
Use 34
111-6 Program Surveillance and Reporting of Data 34
111-7 Refusal to Issue and Revocation 35
111-8 Publication 36
Series 112: DATA IN SUPPORT OF AN EXPERIMENTAL PERMIT
112-1 General Requirements 39
112-2 Product Chemistry 41
112-3 Environmental Fate 41
112-4 Toxicity Data Requirements Concerning Humans
and Domestic Animal Hazards 43
112-5 Data Requirements Concerning Nontarget
Organism Hazards 47
112-6 Product Performance 48
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1
I. ORGANIZATION AND PHILOSOPHY OF SUBDIVISION I
Subdivision I has been organized into three series of sections.
The first section series (110) deals with general aspects of permits:
scope and intent, definitions, type of testing, and use of cancelled/
suspended pesticides. The second section series (111) outlines the
specific procedures pertaining to the issuance and use of permits.
This includes: labeling and permit requirements; information con-
cerning permit issuance; program surveillance; importation of pesti-
cides ; nonissuance and revocation of permits; and publication of
notices of permit issuance in the Federal Register. The third sec-
tion series (112) outlines data requirements (as found in the pro-
posed 40 CFR Part 158 which will be published in final form in 1983)
for obtaining a permit.
A. General.
1. Scope and intent. The scope of these guidelines covers
both the testing of a pesticide by any person for the purposes of
gathering data necessary to register it under FIFRA sec. 3, and the
testing of a pesticide by public or private research agencies or
educational institutions for the purpose of experimentation. This
experimentation may be agricultural or non-agricultural in nature.
The intent of these guidelines is to provide meaningful instructions
on the specific data requirements for obtaining an experimental use
permit, and to allow for the testing of experimental pesticides
while protecting the environment.
2. Definitions. Definitions of terms for these guidelines
are the same as those found in Part 172, with two additions: the
phrase "public or private research agency or educational institution"
and the term "experimental program" are defined for the first time.
3. Testing requiring a permit. Section 110-3 describes
those instances when an experimental use permit is required. It
also points out exceptions to the requirement for an experimental
use permit, with particular emphasis on a substance or mixture of
substances being field tested for pesticidal value.
4. Instructions, labeling, and limitations for pesticides not
requiring a permit. Section 110-4 provides labeling suggestions
for products which do not require a permit. Compliance with these
suggestions would help to ensure that substances being shipped for
purposes outlined in paragraph (b) of § 110-3 are not labeled in
such a way that they could become an object of enforcement action
for failure to comply with the requirements of FIFRA.
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5. Testing with cancelled and suspended pesticides. Section
110-5 describes the instances when cancelled or suspended pesticides
and pesticides which are under intensive Agency review for risks and
benefits can be used under a permit.
B. Procedures.
1. General. Section 111-1 details the format for submission
of an application for an experimental use permit as outlined on EPA
Form 8570-17, "Application for Experimental Use Permit," and clarifies
points often misunderstood in the past. In addition, it outlines
the review process for experimental use permits and the referencing
of data.
Paragraph (b) of § 111-1 explains the 120-day review period
mandated by sec. 5(a) of FIFRA. The Agency will attempt to review
all applications for experimental use permits within 120 days of
receipt. Requests which have been denied may be resubmitted when
deficiencies are corrected. Permit requests relying on a pesticide
petition for a tolerance, which takes longer than 120 days to review,
can be approved prior to the issuance of a tolerance or temporary
tolerance with the understanding that the crop will be destroyed if
for some reason the tolerance is not established.
Paragraph (d) of § 111-1 discusses how to reference data in
support of an experimental use permit. The time restraint placed on
the Agency in reviewing experimental use permits makes it mandatory
that referenced data be located as quickly as possible.
2. Labeling. Section 111-2 describes the types of labeling
which can be used under an experimental use permit. When labeling
requirements for registration are applicable to pesticides used under
experimental use permits, Subdivision H of the guidelines is referenced.
This section explains when supplemental labeling may be used and
points out the necessary information which is required to appear on
a supplemental label. It also outlines the use of the experimental
program as directions for use.
3. Experimental program. The types of information requested
in connection with an experimental program are delineated in greater
detail in Section 111-3.
4. Permit. Section 111-4 explains the requirements and proce-
dures governing permit issuance, amendment, extension, renewal, and
the maintenance of records. This paragraph also states that a
request for a time extension/renewal of a pesticide petition (no
additional quantity) does not require a fee.
5. Importation of pesticides. Section 111-5 explains
requirements relating to the importation of technical material and
formulated products for use under an experimental use permit.
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6. Program surveillance. The requirements in § 111-6 are
essentially the same as those in § 172.8 of the regulations, except
that the wording is more explicit. ."Ehis section points out who is
responsible for supervising an experimental program under a permit,
the types of information to be submitted; when the information is to
be submitted, and to whom it is to be submitted.
7. Refusal to issue, and revocation. Section 111-7 explains
the procedures to be followed when the Agency refuses to issue a
permit or revokes a permit. This section describes a new procedure
which allows the applicant the right to request that reasons put
forth in the refusal of a permit be modified or dismissed due to the
properties of the pesticide chemical, its proposed use pattern, or
other extenuating circumstances. In the event that an applicant
wishes to contest a refusal to issue a permit or to contest a revo-
cation of a permit, he is required, within twenty days after receipt
of such written notification, to file a written request with the
Administrator requesting an opportunity to confer with the Admini-
strator or his designee. The Administrator will then provide the
applicant with an opportunity to offer a written statement of
facts, explanations, and arguments relevant to the permit refusal
or revocation. Within twenty days after the conclusion of a con-
ference, the Administrator will notify the affected applicant of
his final decision.
8. Publication. Section 111-8 contains the same requirements
as appear in § 172.11 of the regulations, but with elaboration and
clarification. The Administrator will publish notice in the Federal
Register of receipt of those applications for permits which may be
of regional or national significance. He will give prompt notice in
the Federal Register of the issuance of an experimental use permit.
Determination of whether or not a permit is of regional or national
significance can be based on several factors. These include the
acreage which is requested under the permit, the amount of pesticide
product to be applied per acre, whether the chemical has been sus-
pended or cancelled in the past, and results of the data submitted
in connection with the permit.
C. Data in Support of an Experimental Use Permit.
The data requirements to support.experimental use permits have
been proposed in 40 CFR Part 158.. This rule will be published in
final form during 1983. These guidelines describe these data
requirements.
The Agency has tried to allow for as much flexibility in data
requirements as is feasible. The Agency plans to request only those
data necessary to evaluate whether the use of a product under a
permit would result in an: unreasonable adverse effect on humans or
the environment for the duration of the testing period.
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The Agency realizes that data requirements should be flexible;
that is, data requirements should vary depending on the proposed use
pattern and the sites to be tested. While the Agency must, out of
necessity, base general data .retirements on broad use categories,
it does intend to waive data required to support an experimental use
permit if the data would not be necessary in evaluating potential
hazards to man and the environment arising from use under the permit.
Similarly, the Agency may request data in addition to that described
in the guidelines, if such data are necessary to determine whether
a potential hazard to man or the environment may exist.
Studies which are required to support an application for a permit
are generally a subset of those necessary to support registration of
a product under sec. 3 of FIFRA. Therefore, in delineating data
requirements for experimental use permits, the Agency has chosen only
to propose a list of the required tests. Each proposed test is
referenced to the appropriate subdivision of the guidelines (Subdi-
visions D, E, F, G, J, L, and N) which specify the standards for
acceptable testing and the information required in the test reports.
To reprint the standards for each test would only unnecessarily
lengthen these registration guidelines.
1. General requirements. Section 112-1 identifies the
general classes of data necessary to support an application for an
experimental use permit. It also sets forth standards for data
requirements, waivers of data submittal requirements, status of
data reviews in connection with a permit, and the potential of
hazards to endangered and threatened species. This section clari-
fies the status of data submitted in connection with a permit
application. Since use of a pesticide under an experimental use
permit is generally limited and carefully controlled, the data
base needed to evaluate the acceptability of an experimental use
permit is less extensive than that needed to evaluate a registration
application. In some circumstances, data which would not be
sufficient to support a registration may be adequate to support a
permit. Therefore, an applicant should not assume that since the
data had been accepted in connection with an experimental use
permit, such data would also be sufficient to meet the requirements
for registration (although this will be the case in many instances).
When non-acceptance might be likely, the Agency will try to point out
those instances to individual applicants. Furthermore, due to the
120-day time restraint placed on the Agency in connection with per-
mit review, data submitted in connection with a permit which are
not required to support the permit might "not be reviewed. Accord-
ingly, an applicant should not assume that all data submitted in
connection with an experimental use permit have been reviewed and
found acceptable.
As stated in paragraph (c) of this section, the Agency, in
coordination with the U.S. Department of Interior, is likely to deny
application for any proposed testing of experimental pesticides
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unless available data or proposed use pattern clearly indicate minimal
potential threat) in areas where endangered or threatened species
or their critical habitats are known or expected to be present.
2. Product chemistry. Data requirements for product chemistry
(§ 112-2) have been divided into two groups: requirements for all
uses and requirements for food uses. The data requirements for
product chemistry are somewhat flexible. The Agency realizes that,
for new chemicals, a manufacturing process has usually not been
developed beyond the pilot plant stage. The Agency also realizes
that a declaration and certification of ingredient limits may not be
possible. Therefore, the data requirements are based, to some extent,
on the information available with respect to the product's stage of
development.
3. Environmental fate. Data requirements concerning the fate
of a pesticide in the environment (§ 112-3) have been divided into
six categories of products: those with terrestrial food crop and
noncrop uses; those with forestry uses; those with aquatic food crop
uses; those with aquatic noncrop uses; those likely to be discharged
directly into aquatic environments; and those likely to be discharged
by indirect means or to enter wastewater treatment systems. The data
requirements are generally the same as they have been for years, with
the exception of the deletion of data requirements for an activated
sludge metabolism study, and the requirement that criteria be reviewed
to determine the need for a laboratory fish accumulation study. The
need for submitting data on a laboratory fish accumulation study is
now contingent upon the criteria specified in § 165-4(b)(2) being met
or exceeded. These criteria relate to the likelihood of the pesticide
active ingredient and/or its principal degradation products reaching
water or having a half-life in water greater than 4 days, having an
octanol/water partition coefficient greater than 1000, or a having
a propensity to accumulate in the organs and tissues of mammals or
birds.
4. Human and domestic animal hazards. Section 112-4 describes
the toxicity data requirements relating to evaluation of human and
domestic animal hazards. These data requirements have been divided
into three groups: data required for the use of any pesticide; data
required for use of a pesticide which is likely to result in residues
on a raw agricultural commodity, food, or feed; and conditional
studies required depending on the nature of the pesticide, its use
pattern, and/or the results of previously-submitted toxicity data.
When an experimental use permit is accompanied by a petition
for a temporary tolerance or temporary exemption from a tolerance,
additional toxicity data as indicated in § 112-4(b)(2) are neces-
sary. These data are needed to insure that the public health is
protected during the marketing of commodities treated with an
experimental pesticide. If the theoretical maximal residue
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contribution ("TMRC") _!/ is equal to or greater than 50% of the
maximal permitted intake ("MPI") 2/, then additional toxicological
information described under § 112-4(b)(2)(iii) is ordinarily re-
quired. [The Agency recognizes, however, that this mathematical
expression may not have taken into account all relevant factors for
all pesticides. Accordingly, the sec. 3 regulations, at § 162.8(a)
(3), provide for a waiver of the additional data requirements upon
petition by the applicant.] Using this procedure should assure
that "adequate" safety data will be available for toxicological
assessment of experimental use pesticides whose uses result in
residues in or on food or feed. EPA intends to give special con-
sideration to minor uses when the TMRC will exceed 50% of the MPI.
The necessity of the additional data outlined in § 112-4(b)(2)(iii)
will be determined on a case-by-case basis.
5. Nontarget organism hazards. Section 112-5 outlines toxi-
cology data requirements with respect to nontarget organisms includ-
ing insects, fish, birds, and mammals. With the exception of the
nontarget insect studies, these requirements do not differ from
those that have been required over the past several years. The
Agency now requires the submission of a honey bee acute contact
LD50 and acute toxicity to aquatic insects [§ 112-5(b)(2)]. These
are laboratory studies often routinely carried out by basic pesti-
cide chemical manufacturers.
6. Product performance. Section 112-6 outlines product per-
formance data requirements. In general, efficacy data will not be
required to support issuance of a permit. Certain exceptions, such
as public health uses and uses of cancelled or suspended pesticides,
will be handled on a case-by-case basis.
Even though EPA will normally waive efficacy data requirements
under § 112-6, the Agency reserves the authority to request on a case-
by-case basis the summaries, as well as data, from product performance
tests to determine if an extension or renewal of an experimental use
permit involving a request for additional quantities of pesticide
would be warranted. .
I/ "TMRC" is the amount of a chemical residue which is calculated
to remain in an "average" adult human diet. The "average" diet
weighs 1.5 kg and is composed of different food items in an amount
equal to the calculated average intake for each food item. The
TMRC calculation is based on the assumption that the food item
contains the maximum level of residue authorized by existing and
pending tolerances.
2/ "MPI" is the allowable daily intake (ADI) times 60 kg
(average body weight of humans).
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7. Minor uses. EPA has developed several policies concerning
how it intends to handle minor uses and low-volume pesticides. While
..-f/these policies deal with registration procedures, they will also be
r^a.pplied to minor use permit applications to the extent that they are
." applicable. This includes giving priority to a minor use permit appli-
cation for development of data to support a minor use where no re-
gistered alternative is presently available.
II. ISSUES CONCERNING SUBDIVISION I GUIDELINES
This part of the discussion explains the major issues identified
in developing the individual guideline sections of Subdivision I.
A. Testing Without a Permit, §§ 110-3 and -4.
Over the past few years, many questions have been raised concerning
the need for a permit while testing a substance for pesticidal value.
Regulations established under 40 CFR Part 172 contain § 172.3(a)
which deals with this subject. In these regulations, a substance or
mixture of substances being put through laboratory tests, greenhouse
tests, or limited replicated field trials, in which the only purpose
is to determine its pesticidal value, is not considered a pesticide
within the meaning of FIFRA.
Many inquiries have been received concerning the 10-acre -limi-
tation established under these regulations with respect to pest/site
relationships. Under the old "Land Use" example [§ 172.3(a)(1)], the
term "a particular pest" caused confusion. It was not clear whether
this allowed for testing of 10 acres per pest per site or 10 acres
regardless of pest or site. These proposed guidelines have rewritten
this example, doing away with the term "a particular pest." The example
is now broken down into three aspects for better clarification: ter-
restrial uses, aquatic uses, and animal treatments. These guidelines,
as now stated, allow for testing against a pest or pests.occurring
on the same site, at the same time, and in the same locality on not
more than ten acres.
A.person planning to conduct tests against the same pest in
.several sites would request a determination from the Agency in accor-
dance with § 110-3(c). Such a request would set forth in writing
the reasons why the pesticide may not be efficacious against the same
pest when it occurs at two different sites.
Labeling suggestions for pesticides not requiring a permit have
been included in these guidelines (§ 110-4). Several commenters have
stated that labeling requirements for pesticide products not requiring
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a permit are unnecessary and outside the scope of the guidelines. The
Agency had contemplated listing label statements which must appear on
such labeling. However, the Agency feels that such labeling detail
may not be necessary due to the limited use and relatively tight
control of such chemicals.
In addition, labeling of such products must be in compliance with
Department of Transportation regulations as well as FIFRA sec. 2(q).
The Agency has instead listed phrases and statements which should not
appear on labels of these pesticides, to prevent confusion with
products being used or shipped under an experimental use permit.
Preventing this confusion would help preclude certain Agency regulatory
enforcement actions that should be directed only toward products that
are being moved illegally.
B. Cancelled or Suspended Pesticides, § 110-5
An experimental use permit is the only mechanism available to
an applicant or registrant to gather substantial new evidence in
connection with a prior cancellation or suspension order. It may
also be used to gather additional data in support of a rebuttal of
a presumption against registration or intent to suspend or cancel a
registration, when such data cannot be gathered through use in
accordance with currently registered labels. However, permits will
not be issued if the use involves treatment of a food or feed item
for which there are no permanent or temporary tolerances, unless
the food or feed item will be destroyed. Section 110-5 of this
subdivision allows for the testing of pesticide products which
have been suspended or cancelled and pesticide products which are
under intensive Agency review for a determination of rebuttable
presumption against registration (RPAR) or continued registration.
An experimental use permit will be issued for use of a cancelled
or suspended pesticide only when the program is designed to gather
substantial new evidence which may materially affect the prior can-
cellation or suspension order, or relative efficacy of alternatives,
and when the use will not be expected to cause an. unreasonable ad-
verse effect on man or the environment. A commenter has suggested
that food or feed treated with a cancelled or suspended pesticide,
while being tested under a permit, should always be destroyed. In
cases where a tolerance has not been established for the chemical
on the crop being tested or when Agency toxicologists believe that
treated foods would be unsafe for human or domestic animal consump-
tion, all treated crops will be required to be destroyed.
It is not the Agency's intention that new uses of any cancelled
or suspended pesticides fall within the scope of § 110-5. This is
because the cancellation or suspension of a pesticide is often based
on a use/site/pest relationship, and such a cancellation or
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suspension notice would then not apply to a new use. Likewise, the
Agency does not consider that new uses of any pesticides that have
been presumed against in registration (i.e., when the new use has
neither been registered nor previously submitted for registration)
fall within the scope of § 110-5. This is because § 162.11 of the
registration regulations is intended to cover only registrations
and registration applications, not experimental use permits. Appli-
cations for new uses of pesticides which have previously been can-
celled, suspended, or presumed against in registration, will be
handled under routine permit application procedures. However, the
Agency will, of course, carry out a careful review of all pertinent
data prior to deciding whether permits should be granted for the
new uses.
The Agency is aware that a cancellation, suspension, or pre-
sumption against registration can be based on data which would be
applicable to all uses of a pesticide chemical. In those instances,
permit applications for new uses of the pesticide would probably
be denied. However, in some cases, data on which a cancellation,
suspension, or presumption against registration is based does not
apply to all uses, and such uses must then be considered on their
own individual merits.
C. Labeling, § 111-2.
Several questions were raised in connection with the labeling
requirements in § 111-2(a). Commenters questioned the requirement
for an appropriate limitation on entry of persons into treated areas.
They also pointed out that the data necessary to establish reentry
intervals are generally not available for new pesticide chemicals at
the time of permit use, and thus compliance is impossible. In
addition, fields must often be entered to collect data required for
registration under FIFRA sec. 3; this activity can be in conflict
with the reentry limitations. The Agency has reviewed this aspect
and agrees that reentry information may not be available. EPA has
written this part to allow for adequate precautions concerning
protective clothing in lieu of a reentry interval. Due to the limited
and controlled use under a permit, such precautions should alleviate
potential problems associated with reentry while at the same time
allow for gathering of the necessary data for future registration.
See also part II.M. of this Discussion for further discussion on
reentry.
Under this same section, the requirements for a crop rotation
interval (the time interval between treatment of a crop with a
pesticide and the planting of a new food crop) were questioned. Some
commenters believe that crop rotation intervals are too restrictive.
They point out that such data are generally not available at this
stage of a product's development. The alternative, an 18-month
rotation restriction on the label, was considered unreasonable since
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most farmers will not allow land to stand idle for this length of
time. While the Agency understands the concern over such a labeling
restriction, it cannot ignore the possibility of illegal residues
occurring in crops rotated with treated crops. Lack of an appropriate
crop rotation restriction can result in such illegal residues of a
pesticide. Crops harvested with such illegal residues are subject
to confiscation and destruction under the Federal Food/ Drug, and
Cosmetic Act. The Agency points out that crop rotation data gathered
during the permit period may be submitted at any time. Upon assessment
of such data, a determination will be made as to whether the restriction
should be modified or deleted.
D. State Permit or License, § lll-4(a)(3)
With the exception of a Federal agency testing on Federal land,
the granting of a Federal permit to ship and use a pesticide would
not eliminate the need for a permittee to obtain individual state
permits or licenses from the states in which he will be conducting
testing. Failure or refusal to obtain a required State permit or
license would result in the modification of a Federal permit by
deletion of testing sites in any state where a permit or license has
not been obtained. Similarly, if a state refuses to grant a permit
or license for use of a pesticide product, such refusal would override
the Federal permit, with respect to that state.
E. Notification of Issuance of an Experimental Use Permit, § 111-8(c).
Under § 111-8, the Administrator will give prompt notice in the
Federal Register of the issuance of an experimental use permit.
Among other things, this notice will include a statement indicating
where the permit is available for public inspection. Due to FIFRA
sec. 10, the only information which will be made available to the
public is the labeling for the product and part of the letter of
permit issuance. Since the letter issuing a permit often contains
information concerning the product's development and may be proprietary
in nature, only that part of the letter dealing with effective dates,
quantity of product, tolerance establishment (if applicable), states
to which the product may be shipped, and statements concerning the
acceptability of the labeling are to be available for inspection.
All other information would have to be obtained through procedures
set forth in the Freedom of Information Act.
F. Data Requirements in General, Series 112.
Requirements for data to support a permit application vary,
depending on the proposed use. That is, agricultural uses generally
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require more data than indoor uses. However, indoor uses at times
may require types of toxicology or exposure data that are different
and more extensive than those for outdoor uses due to significant
potential exposure to humans. The data requirements are based on
potential exposure to man and/or the environment. Depending on this
potential exposure from the proposed use, additional data or different
types of data may be required.
G. Product Chemistry Data Requirements, § 112-2.
The Agency must have certain chemistry data to evaluate pesticide
products submitted for permits. However, since many products are in
an early stage of development when a permit is requested, data which
are generally required concerning the manufacturing process, uninten-
tional ingredients, ingredient limits, and product analytical methods
may not be available to the extent required for registration of such
a chemical. Commenters have suggested that certain allowances be
made in those cases when the data have not yet been developed for
new pesticide products.
The Agency understands that data concerning the manufacturing
process, unintentional ingredients, ingredient limits, and analytical
methods may not be available for new pesticide products at this stage
of their development. In such cases, the Agency believes that the
following information is sufficient, in connection with an experimental
use permit:
1. In lieu of a full description of the manufacturing'process,
a schematic diagram and brief description of the manufacturing process
should be submitted for a .pesticide product which is in the --development
stage. For registered pesticides, a full description of the manufactur-
ing process is required.
2. A discussion of unintentional ingredients, when available,
and declaration and certification of ingredient limits are required
for established pesticide products only.
3. In lieu of full product analytical methods and data, rudi-
mentary analytical methods and data are required. For established
pesticide chemicals, analytical methods and data would be required,
when available.
H. Ninety-Day Feeding Studies, § 112-4(b)(2).
The Agency has requested, for many years, two 90-day feeding
studies (one employing a rodent and one a nonrodent) which establish
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12
a "no observed effect level" (NOEL), in connection with permit
applications accompanied by a petition for temporary tolerance(s).
This requirement remains unchanged as set forth in § 112-4.
A commenter, however, has suggested that this requirement may
be excessive for the initial establishment of a temporary tolerance
in its first year. He believes that two 4-week studies should suffice
for the temporary tolerance and that, prior to an extension or renewal
of the tolerance, results of the two 90-day studies be submitted.
Whenever the use pattern of a pesticide results in repeated
human exposure to the product, its active ingredient, metabolites,
or degradation products, through an oral route of exposure, the Agency
believes that the minimum amount of subchronic toxicity data needed
to support such a use would still be two 90-day feeding studies from
which a NOEL can be established. These studies are generally conducted
on the active ingredient, but may be requested on major metabolites
or degradates in certain instances.
I. Acute Inhalation and Dermal Sensitization Studies, § 112-4(b)(3).
The Agency requires the submission of a dermal sensitization
study and an acute inhalation study in support of a permit when these
studies are required to support registration.
J. One-Year Interim Report on a Chronic Feeding Study, § 112-4(b)(2)
In the. past,, the .Agency has requested, in addition-to acute and
subchronic data, information from ongoing or completed*^^ chronic toxi-
city studies in support of a petition for temporary tolerance(s),
when residue levels of a product exceeded 0.1 parts per million (ppm)
in or on a raw agricultural commodity. This was because residues
higher than 0.1 ppm were expected to present a higher degree of risk
to man through oral ingestion of the treated commodity than would
residues of 0.1 ppm or less (an arbitrary breakpoint).
The Agency has decided to replace the 0.1 ppm criterion level.
In its place is a system which estimates potential risk to man based
on residue levels of the product in or on raw agricultural commodities
and on the toxicologic potency of the product. This more realistic
approach to estimating risk considers the independent nature of both
of these variables and the relative relationship between them. The
system involves use of the TMRC (theoretical maximal residue con-
tribution) and the MPI (maximal permitted intake). (These terms
are explained in part I.e.4. of this Discussion.) The higher degree
of potential risk ordinarily warrants submission of additional
toxicology data. Therefore, in such cases, a one-year interim report
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on a chronic feeding study and a first-generation interim report on
a reproductive study are required.
For products with established tolerances, the TMRC is calculated
from the cumulative total residues of the product in or on all treated
crops with existing and pending tolerances. The'MPI is ordinarily
derived from the NOEL (no observed effect level) determined in chronic
toxicity studies already submitted to the Agency in support of the
established tolerances. When the TMRC exceeds 50 percent of the MPI
and sufficient chronic data are not available, a judgment is made on
the adequacy of the entire toxicologic data base supporting the pro-
posed use. The judgment would include consideration of the incre-
mental increase in exposure resulting from the proposed use. Only
when sufficient toxicologic information is not available or the
increase in exposure is significant would additional data from chronic
studies be required.
For products without established tolerances, the TMRC is calcu-
lated from the proposed use and other pending tolerances. The MPI
is usually derived from the NOEL observed in chronic toxicity
studies. In the absence of chronic studies, the MPI may be derived
from a NOEL observed in subchronic studies and an appropriate
safety factor. When the TMRC exceeds 50 percent of the MPI and
the anticipated exposure resulting from the proposed use is signi-
ficant, interim reports on chronic feeding and reproductive studies
are required.
Following a careful review of toxicology studies required in the
past to support temporary tolerances, 50 percent of the MPI was
selected as the breakpoint that is most consistent with prior Agency
policy on toxicity data requirements. The intention of the new system
is not to appreciably alter the studies required, but rather to pro-
vide a more realistic and scientifically-supportable means for esti-
mating potential risk to man. Estimation of this risk necessitates
consideration of the inherent toxicity of the product as well as
residue levels of the product in or on raw agricultural commodities.
The Agency realizes that other relevant factors, particularly those
relating to exposure, must also be taken into account when determining
the need for additional toxicity information. Therefore, the Agency
considers the 50 percent limit to be a flexible guidepost subject to
reasonable variation on a case-by-case basis.
K. Product Performance, § 112-6.
Section 3(c)(5) of the amended FIFRA provides that the Admini-
strator may waive data requirements pertaining to efficacy. The
Agency intends to operate on a policy of requiring submittal of
efficacy data on a case-by-case basis for those products having
uses of known public health significance [as defined in § 162.18-2
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(d)(2) and (3) of the FIFRA regulations], and waiving efficacy
data submittal requirements in connection with all other uses.
(Refer to § 90-l(b) of Subdivision G for details concerning waiver
of efficacy data submittal requirements.)
In general, those uses for which product performance will be
waived for registration will also be waived in connection with
experimental use permits. Exceptions involve permit extensions,
renewals, or requests for additional quantities under a permit.
Registrants may also choose to apply for experimental use permits
to test for pesticidal efficacy in those cases when residue data
related to tolerance applications can be gathered simultaneously.
product performance data may be required on an exceptional case
basis so that an evaluation of the need for additional testing
under a permit can be made.
Maintenance of Records.
The Agency currently requires all producers of pesticides,
produced in connection with a permit, to maintain records in accor-
dance with 40 CFR Part 169. The Agency considers that such records,
if accepted later in connection with registration, would become
part of the history of an application and should be maintained for
as long as the registration is valid. Such records may be held as
microfilmed copies, however, provided that the recordkeeper certi-
fies that such microfilmed records are complete and legible.
M. Reentry Data.
Requirements for data on field residues, exposure, and toxicology
to establish reentry levels appear in Subdivision K, Exposure Data
Requirements: Reentry Protection. The Agency requested public comments
in the process of establishing reentry intervals (43 FR 37350; 8/22/78).
The Agency's position at present is not to designate any reentry data
requirements for a permit application, only for a registration
application.
N. Gene Mutation Tests.
Currently, the Agency requires, at § 112-4(b)(2)(ii)(C), a battery
of three mutagenicity studies to assess gene mutations, chromosome
aberrations, and primary DNA damage, in support of a permit where the
product will be used on food or feed.
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EXPERIMENTAL USE PERMITS
Series 110: GENERAL
§ 110-1 Scope and intent.
(a) Authority. The Administrator of EPA is authorized by
FIFRA sec. 5 (a) to issue an experimental use permit if he determines
that an applicant needs such a permit in order to accumulate
information required by FIFRA sec. 3. (This includes development
of efficacy information for the purpose of ensuring that labeling
submitted for registration contains directions for use which are
necessary and sufficient for the product user to achieve the expected
pest control results.) The Administrator is also authorized under
FIFRA sec. 5(g) to issue an experimental use permit to any public
or private agricultural research agency or educational institution
for purposes of experimentation.
(b) Purpose of sec. 5. The purpose of FIFRA sec. 5 is to
regulate the extensive testing of prospective pesticide products
when such testing is for the purpose of developing -data -to support
an anticipated product registration or label, or when such testing
is for the purpose of undertaking experimental field research
conducted by research agencies and educational institutions. The
law permits this pesticidal use of such products which have not
first been registered. Products covered by this regulation are
limited to those that require field testing in order to accumulate
the necessary information for prospective registration. Section
5(d) of FIFRA provides that, in the case of a pesticide containing
any chemical or combination of chemicals which has not been included
in any previously-registered pesticide, the Administrator may
specify that studies be conducted to determine whether the testing
of a pesticide, containing a chemical or combination of chemicals
not included in a, previously-registered pesticide, under a permit
may cause unreasonable adverse effects on humans or the environment.
(c) Intent. The intent of these guidelines is to amplify the
requirements set forth in the regulations (40 CFR Part 172) concerning
the procedures and basic data requirements for issuance of an
experimental use permit.
(d) Purposes. (1) Permit. The purpose of an experimental
use permit is to allow testers to use their prospective products
under extensive, controlled, field or actual use conditions, so
that they can develop data necessary to evaluate efficacy and
potential for safe use or adverse effects on humans and the
environment. Most of these data would eventually be used to support
applications for registration of the prospective products.
(2) Subdivision I. The purposes of this subdivision are:
(i) To provide pertinent information and instructions to both
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applicants for experimental use permits and the public, relative to
four major subjects:
(A) Current permit procedures;
(B) Data and labeling requirements for experimental use permits
(C) Acceptable test methods for the development of required
data; and . •-....
(D) .Information required in reports from testing under an
experimental use permit.
(ii) To enable applicants to improve the quality, completeness,
and consistency of permit applications, thus permitting an efficient
review of applications; and
(iii) To,assure that both data development and review are
based on a uniform set of standards.
(e) Distribution. Pesticides under experimental use permits
may not be sold or distributed other than through participants.
When sold or distributed through participants, such pesticides may
be used only at an application site of.a cooperator and in accordance
with the terms and conditions of the experimental use permit. Pre-
registration marketing programs for pesticides do not fall within
the scope of FIFRA sec. 5 nor do indefinite renewals of experimental
use permits as a substitute for full registration.
•/
§ 110-2 Definitions.
Terms used in this subdivision, except the term "applicant,"
shall have the meanings set forth in FIFRA, at § 162.3 of the FIFRA
sec. 3 regulations, and at § 60-2 of Subdivision D. In addition,
for the purposes of this subdivision:
(a) The term "applicant" means any person who applies for an
experimental use permit, pursuant to sec. 5 of the Act.
(b) The term "permittee" means any applicant to whom an
experimental use permit has been granted.
(c) The term "cooperator" means any person who grants permis-
sion 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.
(d) The term "participant" means any person acting as a
representative of the permittee.and responsible for making available
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for use, or supervising the use or evaluation of, an experimental
use pesticide.
(e) The phrase "value for pesticide purposes" means that
characteristic of a substance or mixture of substances which produces
an efficacious action on a pest.
(f) The phrase "public or private research agency or educational
institution" means any organization engaged in research pertaining
to the 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 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.
(g) The term "experimental program" means the plans and
procedures of all activities to be carried out under the auspices
of an experimental use permit.
(h) The term "residential areas" means those areas where an
application of a pesticide is to be made directly to humans or
pets or where application of a pesticide is to be made in, on, or
around all structures, vehicles, or areas associated with the
household, home life, or noncommercial areas where children spend
time. These areas include but are not limited to:
(1) Gardens, non-commercial greenhouses, yards, patios, houses,
pleasure marine craft, mobile homes, campers and recreational
vehicles, non-commercial camp sites, home swimming pools, and
kennels;
(2) Articles, objects, devices, or surfaces handled or con-
tacted by humans or pets in all structures,, vehicles, or areas
listed in paragraph (h)(l) of this section; and
(3) Educational, lounging, and recreational areas of pre-
schools, nurseries, schools, and day camps.
§ 110-3 Pesticide uses for which an experimental use permit is
required.
(a) General. Except as provided by paragraph (b) below, an
experimental use permit will be required for the use of: (1) An
unregistered pesticide; or (2) A registered pesticide when used
in a manner inconsistent with its labeling, as defined under FIFRA
sec. 2(ee).
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(b) Exceptions. (1) When a permit is not required. An
experimental use permit will not be required when:
(i) A pesticide is being used in accordance with an exemption
from requirements of the Act issued by the Administrator under
FIFRA sec. 18;
(ii) Testing of a pesticide is authorized by a state under
FIFRA sec.5(f) [testing of a pesticide under sec. 5(f) must be in
accordance with Subpart B of Part 172]; or
(iii) A pesticide is being put through laboratory or greenhouse
tests, or limited replicated field trials; and
(A) The purpose of the test(s) is only to determine the value
of the substance for pesticidal purposes or to determine its toxicity
or other properties;
(B) The producer, applicator, or any other person conducting
a test does not expect to receive any immediate benefit from the
pest control caused by the use of the substance in the test; and
(C) The product will not be used in residential areas where
it will be accessible to the general public, either in its packaged
form or after application.
(2) Examples of uses for which a permit is not required. For
purposes of paragraph (b)(l)(iii) of this section, the Agency will
presume that the following types of tests do not require an experi-
mental use permit. Tests outside the following categories do not
necessarily require an experimental use permit. However, with
respect to tests outside the scope of the categories described
below, the user must be prepared to show that the test falls within
the scope of paragraph (b)(l)(iii) of this section.
(i) Terrestrial use. (A) Tests which are conducted on a
cumulative total of not more than 10 acres, provided that:
CL) When more than one intended target pest occurs at the
same time in the same locality, the 10-acre test shall encompass
all of the intended target pests; and
(2) When more than one target pest is intended, and they do
not occur at the same time or in the same locality (or application
of the pesticide would not be at the same time), up to 10 acres
may be treated for each target pest.
(B) 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
such substance or mixture) shall be destroyed or consumed only by
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experimental animals; or
(C) A tolerance or exemption from a tolerance has been
established for residues of the substance on the food or feed crop
involved, and such tolerance will not be exceeded.
(ii) Aquatic use. Tests conducted on a total of not more
than one surface-acre of water, provided that:
(A) Waters which are involved in, or which are affected by,
such tests will not be used for irrigation purposes, drinking
water supplies, or body-contact aquatic recreational activities;
and
(B) No such test may be conducted in any waters which contain,
or which affect, any fish, shellfish, or other animals or plants
taken for recreation or commercial purposes and used for food or
feed unless a tolerance has been established and will not be exceeded,
or unless an exemption from the requirement for a tolerance has
been established.
(iii) Animal treatments. Tests shall be conducted only on
experimental animals that will not be used as food or feed .unless:
(A) A tolerance or exemption from a tolerance has been
established for any food (meat, fat, meat byproducts, eggs, and/or
milk) produced from the animal which is likely to contain residues;
and
(B) The tolerance will not be exceeded.
(C) Request for determination. Any person who is uncertain
as to whether testing may be conducted without a permit may submit
a request for determination to the Agency. Such a request shall
include all information pertinent to the proposed use and a summary
of all information known about the pesticide.
§ 110-4 Instructions, labeling, and limitations for pesticides not
requiring a permit.
1 (a) Instructions. (1) Pesticides which are exempt from the
requirement to obtain an experimental use permit under § 110-3(b)
(l)(iii) of this subdivision should contain instructions necessary
to carry out the intended testing. These instructions should be
provided separately from the label on the container.
(2) Instructions should not include pesticidal claims. For
example, one cannot say "To control (pest), apply..."; one can say
"To study effects of this product on (pest), apply..."
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(b) Labeling. Labeling of non-registered pesticidal chemicals
should not bear:
(1) Any pesticidal claims, either expressed or implied.
(2) A product identification (product name) which expresses
or implies pesticidal intent or value.
(3) Directions for use expressing or implying pesticidal intent.
(4) The words "For Experimental Use Only" (inferred association
with EPA Experimental Use Permit). However, the phrase "For research
purposes only" might be appropriate.
(c) Limitations. Unregistered pesticide products which do
not require an experimental use permit under § 110-3(b)(1)(iii) of
this subdivision:
(1) Are still subject to the Hazardous Materials Transportation
Act and the Endangered Species Act. Studies with pesticides shall
not be conducted in areas containing, or suspected of containing,
threatened or endangered plants or animals or their critical
habitats. When there is some question as to whether such organisms
may be affected by prospective testing, the appropriate staff in
the U.S. Department of Interior shall be notified.
(2) Are limited in use to such studies as are necessary to
support an experimental use permit and its labeling. This limitation
would not apply to public or private agricultural research agencies
or educational institutions.
§ 110-5 Experimental use permits for pesticides under intensive review
of risks and benefits, and for cancelled or suspended
pesticides.
(a) Pesticides under intensive review of risks and benefits.
An experimental use permit for use of a pesticide which is under
intensive evaluation due to a rebuttable presumption against
registration (RPAR) may be issued, provided that the proposed use
will not result in an unreasonable adverse effect on man or the
environment, and:
(1) The proposed use does not involve treatment of a raw
agricultural commodity or feed or food item; or
(2) The proposed use does involve treatment of a raw agricultural
commodity or feed or food item, and:
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(i) Treated raw agricultural commodities or feed or., food
items will be destroyed or used for research purposes only; or
,?~'r'.''
(ii) Treated raw agricultural commodities have permanen-t^pr.. .
temporary tolerances or exemptions from tolerances for residues 5f
the active ingredient in accordance with 40 CFR Part 180; treated
feed or food items have food additive regulations established for
residues of the active ingredient in accordance with 21 CFR Part
193 and/or 561; and all inert ingredients are cleared in accordance
with 40 CFR Part 180 Subpart D.
(b) Cancelled or suspended pesticides. An experimental use
permit may be issued for use of a pesticide at a site and on a pest
for which registration has been cancelled or suspended, provided
that this use satisfies the requirements of paragraph (a) of this
section, and the proposed experimental program is designed for the
purpose of gathering substantial new evidence which may materially
affect a prior cancellation or suspension order, or to establish
relative efficacy of alternatives.
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Series 111: PROCEDURES
§ 111-1 General requirements.
(a) Experimental use permit applications. An application for an
experimental use permit must be submitted in triplicate. Each of
the three copies must be set up in bound removable sections lettered
A through G with margin tabs. A completed experimental use permit
application shall consist of:
(1) Application form. A completed application form for an
experimental use permit, EPA Form 8570-17, or a more recent equivalent.
(i) If an EPA company number (item 2) has not been previously
assigned, indicate "none," and a number will be assigned.
(ii) Third party applicants (those who will be testing another
firm's registered product) need not complete item 11 on the form.
(iii) If a registered pesticide is.being tested and the material
will be purchased locally, items 5 and 10 on the form may be left
blank.
(iv) Item 8 "product" means pounds (avoirdupois weight) or
gallons of formulated product, and pounds of "active equivalent"
means pounds of active ingredients.
(v) Item 9 on the form "Proposed period of shipment/use."
Give time for shipment of material, and the actual anticipated use
season. Note: whenever possible, the Agency will use the earliest
date listed as the effective date for the permit.
(2) Product chemistry data. Section A of the application
shall contain the chemical and physical properties of the chemical
being tested, and a completed confidential statement of formula,
EPA Form 8570-4. Refer to § 112-2 for the types of information
required in this section.
(3) Labeling. Section B shall contain the product's labeling
to be used under the permit. Refer to § 111-2 for the types of
information required to appear on labeling, and the .types, of labels -
which may be used.
(4) Toxicology data. Section C shall contain pertinent
toxicity data with respect to human and domestic animal safety and
nontarget organism hazards. Section C shall consist of two parts:
Cl and C2. Part Cl shall contain data on the toxicity of the
pesticide to humans and domestic animals, and part C2 shall contain
data on the toxicity of the pesticide to nontarget organisms.
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Refer to §§ 112-4 (for part Cl data) and 112-5 (for part C2 data)
for the individual studies to be required.
(5) Residue and environmental data. Section D shall consist
of three parts: Dl, D2, and D3.
(i) Part Dl shall contain residue data for food or feed com-
modities [refer to paragraph (d) of this section]. If the permit
is accompanied by a pesticide petition, residue data on food/feed
commodities may be referenced to Section D of the pesticide tolerance
petition.
(ii) Part D2 shall consist of residue data on:
(A) Nonfood crops such as tobacco (refer to Subdivision O), and
(B) Foliage or other sites which may relate to worker hazards
or adverse effects on the environment (refer to Subdivisions K and N).
(iii) Part D3 shall consist of appropriate environmental fate
data on the effects of the chemical on the environment. Refer to
§ 112-2 for the types of environmental fate data required.
(6) Product performance data. Section E shall consist of:
(i) Information necessary to justify the proposed label con-
tained in Section B, program dosage rates, and quantity of material
requested; and
(ii) Phytotoxicity data, unless waived by the Agency in
accordance with § 120-l(b) of Subdivision J of these guidelines,
and data concerning adverse effects on inanimate articles or
surfaces.
(7) Tolerance proposal. Section F shall consist of:
(i) A statement to the effect that the use proposed is a non-
food use; or
(ii) A statement that the food or feed will be destroyed or
used for research purposes only, as well as the type of testing in
the case of research (the Agency will assume that the applicant is
aware of the cost involved in destroying a crop); or
(iii) Appropriate citation to:
(A) Appropriate temporary tolerance proposal, if the permit will
authorize use on a new food or feed crop [refer to paragraph (d) of
this section];
(B) 40 CFR Part 180, if the permit will authorize use on a raw
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agricultural commodity for which a tolerance has been established,
and the appropriate rationale to support the fact that the new use
pattern will not require an increase in the existing tolerance; or
(C) 21 CFR Part 193 or 561, if the permit will authorize a
use for which a food or feed additive tolerance has been established.
(8) Proposed testing program. Section G shall consist of a
full description of the proposed testing program to be carried out
under the experimental use permit. Refer to § 111-3 for the types
of information required in an experimental program.
(b) Experimental use permit review. (1) General. Upon
receipt of a complete application [refer to paragraph (a) of this
section] for an experimental use permit, the Agency will review the
submitted data and within 120 days notify the applicant of the
Agency's decision. A permit application that is accompanied by or
relying on a pesticide petition for a tolerance may necessarily be
granted on a crop destruct basis pending the completion of tolerance
review. The Agency will try to review the tolerance petition within
the 120-day period.
(2) Incomplete applications. The Agency will deny an
application for a permit which the Agency finds incomplete (refer
to § 111-7 of this subdivision). The Agency will hold the application
for a permit for 30 days after it has notified the applicant both
of its denial and its statement delineating the kinds the information
needed to complete the file for the permit. The application may
then be withdrawn by the applicant or returned to him by the Agency
unless:
(i) The information necessary to complete the application is
submitted; or
(ii) A letter is received from the applicant requesting that
the application be held by the Agency for a specified period of
time. This time period is not to exceed six months. At the expiration
of the specified time period, the application may be returned to
the applicant or withdrawn by the Agency.
(3) Resubmissions. Applications which are submitted, found
complete, reviewed, and refused for reasons outlined in § 111-7 may
be resubmitted.
(c) Petition for tolerance. (1) Pesticide petition. An
application for a permit to use an experimental pesticide on a raw
agricultural commodity must be accompanied by a petition for
temporary tolerance (or exemption from a tolerance) unless there is
a tolerance (for that pesticide on the commodity) which will not be
exceeded or unless the commodity will be destroyed or used only for
research purposes. A petition for a temporary tolerance shall be
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accompanied by an advance deposit to cover fees as provided by
40 CFR 180.33. Temporary tolerances are established under authority
of sec.' 408( j) of the Ee-de-ral Food, Drug and Cosmetic Act.
• . -^ • '
(2) Food additiv-e: petition. If the pesticide product will be
used in or on feed or food, it must be accompanied by a petition
for a food or feed additive tolerance. Food or feed additive
tolerances are established under authority of sec. 409 of the
Federal Food, Drug, and Cosmetic Act.
(3) Data in support of petition. A petition for a temporary
tolerance (or exemption from a tolerance) or a petition for a food
or feed additive tolerance shall contain such data as are available
on the subjects outlined in clauses (A), (B), (C), (D), (E), (F),
and (G) of 40 CFR 180.7(b).
(d) Referencing data. (1) Data that may be referenced. Data
required under Sections A, C, D, E, and F of an application for an
experimental use permit may be referenced if the data have previously
been submitted in connection with an experimental use permit, an
application for registration or amended registration, or a petition
for a pesticide tolerance.
(2) Information which shall not be referenced. Section B
(labeling) and G (experimental program) shall not be referenced.
(3) Information necessary to reference data. When referencing
previously-submitted data, the following information must be
included:
(i) Appropriate accession number(s) assigned by the Agency;
(ii) The number or file symbol of the experimental use permit,
registration, and/or petition with which the data are associated; and
(iii) The date the data were submitted.
(4) Referencing by public or private agencies. Public or
private research agencies and educational institutions need only
include the registration number of a product when referencing
data; however, if data are not referenced as indicated under paragraph
(d)(3) of this, section, the Agency's required 120-day limit for
review of an application may have to be extended.
§ 111-2 Labeling.
(a) General. Except as provided by paragraphs (b) and (c)
of this section and § 111-5 of this subdivision, every pesticide
product under an experimental use permit shall bear a label containing
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the following information. In addition, labeling must be in com-
pliance with §§ 100-3 through -9, and -11, Subdivision H, except
where negated byZ-the requirements of this section. The label
shall include.:,^; _.
(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."
(4) The name, brand, or trademark of the product [refer to
§ 100-7(a)(2)].
(5) The name and address of the permittee, producer, or
registrant [refer to § 100-7(c)].
(6) The net contents [refer to § 100-7(e)].
(7) An ingredients statement [refer to § 100-7{h)].
(8) Hazard Warnings and Precaution Statements.
(i) All labels under an experimental use permit must carry
the following:
(A) A signal word ("Danger," "Warning," or "Caution") based
on the acute toxicity of the product;
(B) The phrase "Keep Out of Reach of Children" (except in the
case of products that have no likelihood of coming in contact with
children during storage, handling, or application;
(C) A precautionary paragraph warning the user of hazards
which may be encountered in handling, storing, using, or disposing
of the pesticide based on the toxicity of the product and its
proposed use;
(D) Appropriate first aid treatments and antidotes, if avail-
able ; and
(E)- Environmental ..hazard statements.
(ii) The signal word and the phrase "Keep Out of Reach of
Children" must be in the proper type size and appear on the front
panel of the label. The precautionary and first aid statements may
appear elsewhere as long as they are referenced on the front panel.
(iii) Refer to § 100-8 of Subdivision H for additional
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information concerning hazard warnings and precaution statements.
(9) Appropriate limitations (if known) on entry of persons
into treated areas, or a label statement requiring adequate protective
clothing. (Refer to Subdivision K.)
(10) The establishment registration number, except in those
cases where:
(i) Application of the pesticide is made solely by the producer
[refer to § 167.2(a) of the regulations]; or
(ii) The establishment registration number is stamped on the
product container. [Refer to § 100-7(g) of Subdivision H.]
(11) Directions for use. Directions for use on an experimental
use permit label must contain the following information:
(i) Crop(s) or site(s) on which the product is to be used;
(ii) The pest(s) which the product is be used against, or
response the product is intended to induce;
(iii) The dilution and/or application rate(s) to be used;
(iv) The method(s) of application to be used, including types
of application equipment involved;
(v) The timing of application, including timing intervals;
(vi) Pre-harvest intervals when crops are to be treated;
(vii) A crop rotation interval unless data have been submitted
showing no pesticide residue carryover;
(viii) A statement concerning proper storage and disposal of
the pesticide and its container that incorporates the methods
specified in § 111-3(a)(8); and
(ix) Any other information necessary to assure safe and
effective use of the product for its intended purpose.
(12) A misuse statement. This consists of a statement that
use of the pesticide inconsistent with the terms of the experimental
use permit is a violation of Federal law.
(b) Experimental program as directions for use. When the
experimental program contains directions for use, the label shall
state that the product must be used according to the directions in
the experimental program. In addition, the program must accompany
the product and contain the following:
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(1) The statement "For Experimental Use Only";
(2) The statement "This program must be in the possession
of the user at the time of pesticide application"; and
(3) The EPA Experimental Use Permit Number.
(c) Supplemental labeling. Supplemental labeling (labeling
used in connection with a registered label) describing the prospective
use under a permit may be used only in connection with an already-
registered product and shall contain the following information:
(1) The prominent phrase "For Experimental Use Only";
(2) The statement "Supplemental Labeling for the Experimental
Use of (Product Name), EPA Reg. No. , on/in (crop)
(or site) )." (The name of the registered product, the
product's registration number, and the crop or site shall be filled
in.);
(3) The statement "For use only at an application site of
a cooperator and in accordance with the terms and conditions of
the Experimental Use Permit";
(4) Directions for use or a statement referring the user to
the experimental program for directions for use;
(5) The statement "All applicable directions, restrictions,
and precautions on the EPA-registered label are to be followed";
(6) The statement "This labeling must be in the possession of
the user at time of pesticide application";
(7) The EPA Experimental Use Permit Number; and
(8) The name and address of the permittee.
(d) Language. The language used on labeling shall be in
compliance with § 100-6(g) of Subdivision H.
(e) Prominence and legibility. With respect to prominence
and legibility of the print, all labeling shall be in compliance
with § 100-6(c) of Subdivision H.
(f) Point source discharge. Products under an experimental
use permit which are used in a manner that might result in a point
source discharge into a body of water must carry the following
precaution: "Do not discharge into lakes, streams, ponds, or public
waterways unless in accordance with an NPDES permit. For guidance,
contact your Regional Office of the EPA."
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(g) Department of Transportation labeling requirements. The
Department of Transportation (DOT) has labeling requirements for
the shipping containers of pesticide products. See 49 CFR
Parts 170-189. Registrants may incorporate the DOT hazard symbol
(commonly called a "DOT diamond") in their product label if they
so desire/ provided it remains separate and distinct from that
labeling required by EPA.
(h) Claims. (1) Since experimental use permits are issued,
in part, to gather efficacy data, claims such as "controls,"
"suppresses," or "repels" must be modified to reflect that the
product is being evaluated for such purposes, i.e., "to evaluate
control of," "to evaluate suppression of," or "to evaluate repellency
of" pest, growth, or behavior. Such modification of claims must
take place throughout the label.
(2) There may be no false or misleading statements on the
label. Refer to § 100-5(b) of Subdivision H for information concerning
false and misleading statements.
(i) (Reserved)
(j) Warranty. Statements expressing or implying that use of
a product is beyond the control of a permittee are not allowed.
The use of a pesticide under an experimental use permit must be
under the total control of a permittee. Refer to § 100-5(b)(l) of
Subdivision H for additional information concerning warranties.
§ 111-3 Experimental program.
(a) Required program information. The- experimental program
in support of an application for an experimental use permit shall
contain the following information:
(1) Participants and cooperators. (i) The names and
qualifications of the individual participants who will be supervising
the experimental work.
(ii) The names, addresses, and telephone numbers of cooperators
as they become available. Applicants must certify that the
cooperators and participants listed have been contacted and have
agreed to participate in the experimental testing.
(2) States and acreage. (i) The states and territories in
which the pesticide will be used, along with the approximate amount
of product, active ingredient, and acreage to be treated in each
state, and estimated number of test locations. When possible, give
the counties in each state where testing will take place. When
acreage does not apply, give the extent of testing per state in
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more appropriate terminology. States to which the product will be
shipped for further distribution must be identified.
(ii) EPA normally will advise proper officials in the affected
States within seven days of issuance of the permit and in any case
prior to the scheduled date of use.
(3) Program details. The details of the proposed program,
including:
(i) A general description of the procedures and types of data
planned to be collected during the test program. Note; submission
of a description of the pest control evaluation procedures to be
used in assessing the level of pest organism(s) or damage in test
plots is recommended, since the appropriate procedures and criteria
will vary for each use pattern.
(ii) The target pests or organisms the product is to be tested
against, or the type of plant regulator, desiccant, or defoliant;
(iii) The crops, animals, surfaces, materials, buildings, or
sites to be treated;
(iv) The approximate size and number of tests (including
replicates) per state; and
(v) For seasonal pests and crops, the desired months for
pesticide application(s), the use pattern, intended plot sizes,
number of replicates, dosage rates, method of application, season
of use, and timing of application (preplant, postemergence, multiple,
and similar information).
(vi) The proposed experimental program, including number of
years of proposed testing and the number of persons available to
supervise the program.
(4) Objectives. The specific and detailed objectives of the
proposed program (i.e., type(s) of data to be collected, such as
performance, yield, phytotoxicity, and environmental residues).
Indicate long-range testing plans, including how many years of
experimental testing are planned.
(5) Applications higher than label rate. Applications at a
higher-than-label rate, for such purposes as phytotoxicity and
residue testing, shall be delineated. This shall include rates,
acreages, and, for food uses, disposition of treated crops or
animals. (See § 121-l(b)(3) of Subdivision J for phytotoxicity
testing rates.)
(6) Quantity of product. The maximum quantity of product to
be authorized under an experimental use permit shall be sufficient
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to allow for the generation of all test results necessary to support
intended label claims. Requests for amounts that appear to be
excessive or that have no justifiable rationales will either be
denied or reduced by the Agency to amounts which are adequately
justified by the information submitted.
(i) The following criteria should be used by an applicant to
determine the quantity of pesticide needed for use under a permit:
(A) The label variables being proposed by the applicant, such
as dosages, pests, frequency of application, method(s) of application,
crop(s), site(s), use pattern, pest/crop/site distribution, and
cultural or industrial practices;
(B) The test plot size, replication, geographical distribution,
and number of plots per variable being considered; and
(C) Registration test standards and requirements.
(ii) It is recognized that not all studies attempted will
result in the development of data supportive of the product claims
due to invalid tests, failure to obtain cooperators, failure of
pest populations to appear in sufficient numbers, climatic consider-
ations, and other factors; limited overages may be incorporated to
cover such possibilities.
(iii) Limited experimental programs which may not lead to
registration in one or two years are acceptable. However, successive
extensions of permits which do not provide appropriate data or do
not make adequate progress toward registration may be 'denied by the
Agency.
(iv) As a result of reviews (such as in toxicology, environmental
fate, and fish and wildlife), the Agency may find it necessary to
reduce quantities below those necessary to develop product performance
test results or to deny issuance of a permit, whenever a sufficient
potential hazard would be expected to exist or whenever there are
insufficient data to determine the possible adverse impact of the
pesticide and its use on man or the environment.
(7) Duration. (i) A suitable duration for the permit which
is commensurate with the program should be proposed. Permit
applications which cover the entire period of proposed experimental
work are encouraged rather than applications seeking approval on
a year-to-year basis. If the permit period covers more than one
season, the applicant should ensure that the proposed testing
programs are outlined for each season.
(ii) Proposed programs, when testing is to be conducted over
several seasons, need only be outlined in a general manner (approximate
studies, acreage, and use rates). Specific details may be supplied
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as they become available but must be submitted before the field
testing tasks place.
(8) Disposal. (i) A statement describing the method of
disposition of any unused pesticide and unused pesticide containers
shall be provided. Disposition may include disposal in accordance
with 40 CFR Parts 165 and 257, or return of the product to the
permittee. The permittee may dispose of or store the unused pesticide
and containers in accordance with 40 CFR Parts 165 and 257 or, if
the product is currently registered, he may relabel it and use it
in accordance with the registered label.
(ii) It is the responsibility of the permittee to ensure that
pesticide containers are returned to the permittee for disposal or
that instructions are given to the participant and/or cooperator
for proper disposal. In the case of the latter, such instructions
shall also be stated in the program and shall be consistent with
criteria and standards issued pursuant to the Resource Conservation
and Recovery Act (P.L. 94-580) in 40 CFR Parts 165 and 257.
(b) Agency and institutional programs. Research agencies and
educational institutions may request an "experimental program"
under an experimental use permit to cover the testing of those
pesticides and use patterns which comprise the research program of
the agency or institution. Such a program should list the pesticide(s)
to be tested, the use pattern(s), and acreage or sites to be employed
for each use pattern.
(c) Inadequate programs. Programs submitted for Agency review
and found inadequate (e.g., lack of personnel to carry out the
program, or lack of detailed program) will be deemed unacceptable
and an experimental permit will not be granted.
§ 111-4 Permit.
(a) Issuance. A permit will be issued only after a review of
the data submitted or referenced in support of it has been completed
by the Agency and a determination has been made that conditions set
forth in all sections of this Subdivision have been met.
(1) A permit will be issued subject to such instructions as
necessary to ensure that:
(i) There is adequate control over the use of the experimental
compound;
(ii) The use will not result in an unreasonable adverse effect
on man or the environment; and
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(iii) Data necessary to register a compound or ensure that
labeling is in compliance with FIFRA sec. 2(q) will be gathered;
(2) Permits will be issued subject to: a specified time
period; a specified quantity of product; use in specified states;
use in accordance with acceptable labeling and experimental program;
and the condition that the specified studies requested are conducted
during the experimental program.
(3) Prior to shipment to or use in a state, a permittee
must consult with the pesticide regulatory officials of the state
and obtain a state permit or license if such is required.
(b) Amendments, extensions, and renewals. (1) Amendments.
prior to shipment to unauthorized states, shipment.of unauthorized
quantities of product, or use of a product contrary to accepted
labeling and/or program, an applicant must request in writing and
receive written permission to amend the permit.
(2) Extensions. Extensions of time for an experimental use
permit may be requested.
(i) A request to extend a permit shall be accompanied by
the proper application form and supporting data as outlined in
§ lll-l(a). Information previously submitted for sections A, C,
D, E, and F on the application form may be referenced to the original
permit if appropriate. Sections B and G may not be referenced.
(ii) All data pertaining to registration requirements which
have been collected to date under the original' permit must be
submitted. The request should be accompanied; by an up-to-date
report .detailing shipping and testing under the original permit.
(3) Renewals. A request for renewal of a permit will be
considered in the same manner as a request for extension.
(4) Unconducted programs. If an experimental program is not
conducted for any reason, approval of that same program for the
following year will be done on a pro forma basis without additional
review.
(5) Tolerance extension/renewal. A permit established in
connection with a temporary tolerance or temporary exemption from
a. tolerance and/or food or feed additive tolerance may be extended
or renewed only upon extension or renewal of the temporary tolerance
or temporary exemption from a tolerance and/or food or feed additive
tolerance (unless full tolerances or exemptions from a tolerance
have been established in the interim). Refer to 40 CFR 180.33(b)
for the fees involved. Note: if the extension/ renewal does not
involve any additional quantity of pesticide (i.e., a time extension
to utilize material unused from the original permit), a fee is not
required.
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(c) Maintenance of records. All producers of pesticides
produced pursuant to an experimental use permit shall maintain
records in accordance with 40 CFR Part 169.
§ 111-5 Importation of pesticides for experimental use.
(a) 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 applicant for
such permit states that such importation will occur. The labeling
of the technical material must comply with FIFRA sec. 2(q), and the
material must be imported in accordance with the regulations for
importing pesticides and devices, as delineated in 19 CFR 12.110.
(b) Formulated products imported without registration may not
be moved within the United States prior to being labeled with an
approved label from the Agency (refer to § 111-2 of this subdivision)
§ 111-6 Program surveillance and reporting of data.
(a) Program surveillance and reporting of adverse effects.
The permittee shall supervise the test program and evaluate the
results of testing at each site of application. The permittee
shall also report immediately to the Agency any adverse effects
resulting from use of, or exposure to;,, the pesticide.
(b) Reports to EPA. Reports submitted to the Agency shall
include the following:
(1) Name and street address of the shipper of any pesticide
covered by the permit, and place or places from which shipped;
(2) The names, addresses, and phone numbers of all consignees
and cooperators;
(3) Amount of each shipment;
(4) Total quantities of technical material imported, if any,
to formulate pesticides covered by the permit;
(5) List of states into which shipments were made;
(6) A description of the disposal action for all used pesticide
containers and any unused pesticides, including amount disposed of
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and the method and site of disposition (the disposal of pesticides
and their containers that are identified as hazardous waste pursuant
to 40 CFR Part 250 shall be reported to the Agency's Regional
Administrator in accordance with 40 CFR sees. 250.23 and 250.43-5.);
(7) The method of disposition of affected food and/or feed;
and
(8) A full accounting of all material allocated under the
permit/ e.g./ shipped, used, returned, or destroyed.
(c) Reports to USDA. In the case of any meat-producing
animals or birds that receive a direct application of any experimental
use pesticide and will not be destroyed, 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, D.C. 20250, at least 10 days before
the animals are to be shipped for slaughter. This requirement may
be waived, on request, by the U.S. Department of Agriculture.
These provisions do not exempt treated food-producing animals and
their products from compliance with other applicable inspection
requirements.
(d) Failure to submit reports. Failure to submit required
reports constitutes grounds for revocation of the permit, and may
constitute a violation of sec. 12(a)(2)(N) of FIFRA.
(e) Advance notification. 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
to EPA or the state of the intended dates, times, and sites on
which such experimental use pesticide will be applied.
(f) Entry and inspection. The permittee, participants, and
cooperators in the experimental use program shall permit any
authorized representative of the EPA or state enforcement personnel,
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.
§ 111-7 Refusal to issue and revocation.
(a) Refusal to issue. Whenever it is determined that issuance
of an experimental use permit is not justified, or that the issuance
of such a permit would cause unreasonable adverse effects on humans
or the environment, or that for any other reason provided under
the law a permit shall not be issued, the applicant shall be notified
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in writing. The applicant may then request a waiver of such conditions
within 30 days after receipt of a letter outlining the reasons for
refusal, or he may request that the permit application be placed in
abeyance while information necessary to correct the original
application and bring it into compliance with these regulations is
being obtained. [Refer to § lll-l(b)(2) of this subdivision.]
(b) Revocation. (1) The Administrator may revoke an experi-
mental use permit if:
(i) The terms or conditions of the permit are being violated;
(ii) The terms or conditions of the permit are inadequate to
avoid unreasonable adverse effects on man and the environment;
(iii) The tolerance or the exemption from the requirement for
a tolerance will be inadequate to protect the public health;
(iv) The labeling is not adequate to protect applicators,
users, or workers exposed to a pesticide; or
(v) The applicant has failed to meet any provision of §§ 110-1
through 113-1 of this subdivision.
(2) The Administrator will notify the permittee in writing •
of such revocation.
(3) The permittee shall notify all participants of such
revocation as soon as possible after he receives notice of revocation.
(4) The revocation of a permit shall not preclude the
Administrator from initiating civil or criminal sanctions for
violations of the permit conditions or as otherwise authorized by
law.
(c) Conference. In the event that an applicant for an experi-
mental use permit wishes to contest the refusal to issue an experi-
mental use permit, or a permittee wishes to contest the revocation
of a permit, he must, 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.
§ 111-8 Publication.
(a) Notice of receipt of application. The Administrator
shall publish a notice in the Federal Register of receipt of an
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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 name and address of the applicant; •
(2) The active ingredient(s);
(3) The use pattern(s);
(4) The quantity of pesticide requested;
(5) The total acreage (sites) to be treated;
(6) The location of area(s) of application(s);
(7) The proposed duration of the permit;
(8) A statement soliciting comments from any interested
persons regarding the application; and .. _ '-...-,-
(9) Any other information pertinent to the regional or national
significance of the .permit.
(b) Public hearing. The Administrator may hold a public
hearing in accordance with sec. 21(b) of FIFRA, 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 name and address of the permittee;
(2) The active ingredient(s);
(3) The use pattern(s);
(4) The quantity of pesticide authorized;
(5) The total acreage (or sites) to be treated;
(6) The states where application will take place;
(7) Effective dates of the permit; and
(8) A statement indicating where the experimental use permit
is available for public inspection.
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(d) Availability of permit information. In accordance with
sec. 10 of FIFRA, the only information which will be made available
to the public will be labeling for the product and that part of
the letter of issuance for the experimental use permit dealing -
with the items listed in (1) through (5) below. (All other information
must be obtained through procedures set forth in the Freedom of
Information Act; see 40 CFR Part 2.)
(1) Effective dates; .
(2) Quantity of product granted;
(3) Tolerances established (if any);
(4) States to which the product may be sent; and
(5) Statements concerning the accepted labeling.
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Series 112: DATA IN'SUPPORT OF AN EXPERIMENTAL USE PERMIT
§ 112-1 General requirements.
(a) Data requirements. (1) The following types of data are
required in the support of an application for an experimental use
permit:
(i) General chemistry information on the product; refer to
§ 112-2;
(ii) Environmental fate data; refer to § 112-3;
(iii) Toxicology data; refer to § 112-4;
(iv) Nontarget organisms data; refer to § 112-5; and
(v) Pesticide product performance data; refer to § 112-6.
(2) Data submitted in connection with an application for an
experimental use permit often point out possible problems with the
pesticide's use or disposal, and may therefore cause the Agency to
request additional data that are not routinely required. The Agency
intends to require data beyond those set forth in these guidelines
if such data are necessary for the Agency to determine whether the
proposed use(s) will result in any unreasonable hazards to man or
the environment.
(3) Data need not be submitted or referenced when testing
an EPA-registered product unless the testing involves:
(i) A new food use; or
(ii) A proposed use which might result in residues of the
active ingredient being present in food or feed at a level higher
than that of an established tolerance.
(4) Due to the limited time for reviewing permits mandated by
the Act and the limited exposure and controlled use conditions that
must exist during the permit period:
(i) Acceptance of data submitted in support of an experimental
use permit does not necessarily mean that these same data will be
acceptable in support of registration. The Agency will try, however,
to notify applicants if data are acceptable in support of an
experimental use permit but not for registration.
(ii) Data submitted in connection with an experimental use
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permit but which are not necessary to support the permit may not
have been reviewed. Applicants should not assume that all such
submitted data have been reviewed and found acceptable.
(5) If data required by this subdivision to obtain an
experimental use permit would not be required in order to obtain
a conditional registration under FIFRA sec. 3(c)(7) and 40 CFR
162.18-2, these data need not be submitted to support the application
for a permit.
(b) Waivers and deviations. (1) Waivers. Some studies
required in §§ 112-2 through -6 may not be necessary, depending on
the pesticide being tested, its proposed use, and the quantity of
pesticide to be tested. Section 5(a) of FIFRA allows an applicant
to request a waiver of the requirement to submit data if he feels
that such data are not pertinent to his particular product. It is
the responsibility of the applicant to decide which studies may not
be necessary and to submit an appropriate rationale to support his
decision. Such requests will be reviewed by the Agency on a case-
by-case basis.
(2) Deviations. The Agency fully realizes that the standards
for acceptable testing specified in these guidelines are not always
appropriate for every product. For certain products, some test
standards may be wholly inapplicable. At times, the standards for
conducting a test may have to be modified to accommodate unusual
products. In these cases, the Agency will review deviations from
test standards.
(c) Endangered/threatened species. The potential hazards,
due to proposed pesticide use(s) or disposal during an experimental
use permit, to endangered or threatened plants and animals, or
their critical habitats, will be considered by the Agency. In
coordination with the U.S. Department of Interior, the Agency will
evaluate all available information to determine if the permit
program should be approved, modified, or denied. The applicant
should carefully determine whether geographical areas selected for
the permit activities contain, or are suspected to contain, threatened
or endangered plants or animals or their critical habitats. It is
suggested that the applicant check with applicable State/Federal
agencies prior to filing application for an experimental use permit
to ensure that action under the permit will not result in adverse
effects on endangered or threatened species.
(d) New uses for registered pesticides. Agency policy intends
that, in no instance, will the data requirements to support an
application for a permit covering a new use of an already-registered
pesticide be more stringent than the data requirements to support
the conditional registration of that new use.
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§ 112-2 Product chemistry.
(a) General. All product chemistry studies required "by this
section, should be carried out as specified in Subdivision D of
these guidelines or by comparable protocols.
(b) Data requirements. Product chemistry requirements for
support of an experimental use permit shall include the following:
(1) For all uses:
(i) Product identity; refer to § 61-l(a) for required information.
(ii) Disclosure of ingredients; refer to § 61-l(b) for
required information.
(iii) A description of the manufacturing process; refer to § 61-2
for required information. For a pesticide chemical which is in
the development stage (not in full scale production), a schematic
diagram and/or brief description of the manufacturing process will
suffice.
(iv) Product analytical methods and data; refer to § 62-1 for
required information. For a pesticide chemical which is in the
developmental stage, a rudimentary product analytical method and
data are required.
(v) Physical and chemical properties; refer to §§ 64-1 through
21 for required information.
(vi) Submittal of samples; refer to § 65-1 for required
information.
(vii) A discussion of unintentional ingredients (refer to § 61-
3) shall be submitted to the extent that this information is available.
(2) In addition to those studies required in paragraph (b)(1) of
this section, a declaration and certification of ingredient limits
in accordance with § 62-2 will be required for products with food
uses, to the extent that this information is available.
§ 112-3 Environmental fate.
(a) General. All environmental fate studies required by this
section should be carried out as specified by Subdivision
N of these guidelines o'r comparable protocols.
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(b) Data requirements. Environmental fate data requirements
for support of an experimental use permit shall include the following
studies:
(1) Terrestrial (noncrop, orchard, field and vegetable crop)
uses. The following data are required for pesticides to be used
on orchard, field, and vegetable crops and in noncrop areas:
(i) ' A hydrolysis study; refer to § 161-1 for required information.
(ii) An aerobic soil metabolism study; refer to § 162-2 for
required information.
(iii) A confined accumulation study on rotational crops, for
uses involving crops that are rotated; refer to § 165-1 for required
information. In lieu of this study, a crop rotation restriction
may be placed on the label.
(iv) On a case-by-case basis, laboratory studies of pesticide
accumulation in fish (refer to § 165-4 for required information)
only when the criteria specified in paragraph (b)(2) of that section
are met or exceeded.
(2) Forestry uses. The following data are required for
pesti cides to be used in forests, forest tree nurseries, or in
reforestation sites:
(i) A hydrolysis study; refer to § 161-1.
(ii) An aerobic soil metabolism study; refer to § 162-2 for
required information.
(iii) On a case-by-case basis, laboratory studies of pesticide
accumulation in fish (refer to § 165-4 for required information)
only when the criteria specified in paragraph (b)(2) of that section
are met or exceeded.
(3) Aquatic uses (food crop). The following data are required
for pesticides to be used on aquatic or semiaquatic crops:
(i) A hydrolysis study; refer to § 161-1 for required
information;
(ii) An aerobic aquatic metabolism study; refer to § 162-4
for required information; and
(iii) A confined accumulation study on rotational crops, for
crops that are rotated; refer to § 165-1 for required information.
in lieu of this study; a crop rotation restriction may be placed on
the label.
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(iv) On a case-by-case basis, laboratory studies of pesticide
accumulation in fish (refer to § 165-4 for required information)
only when the criteria specified in paragraph (b)(2) of that section
are met or exceeded.
(4) Aquatic uses (non-crop). The following data are required
for pesticides to be used in or adjacent to any aquatic site other
than that used for production of human food or domestic animal
feed:
(i) A hydrolysis study; refer to § 161-1 for required
information.
(ii) An aerobic aquatic metabolism study; refer to § 162-4
for required information.
(iii) Laboratory studies of pesticide accumulation in fish
(refer to § 165-4 for required information) only when the criteria
specified in paragraph (b)(2) of that section are met or exceeded.
(5) Aquatic impact uses (direct discharge). The following
data are required for pesticides discharged directly into the
natural aquatic environment in association with their use or the
typical method of disposal of pesticide-treated water:
(i) A hydrolysis study; refer to § 161-1 for required
information.
(ii) An aerobic aquatic metabolism study; refer to § 162-4
for required information.
(iii) Laboratory studies of pesticide accumulation in fish
(refer to § 165-4 for required information) only when the criteria
specified in paragraph (b)(2) of that section are met or exceeded.
(6) Aquatic impact uses (indirect discharge and wastewater
treatments). The following data are required for pesticides which
would likely be discharged into aquatic environments by indirect
means or enter wastewater treatment systems: a hydrolysis study;
refer to § 161-1 for required information.
§ 112-4 Toxicity data requirements concerning human and domestic
animal hazards.
(a) General. All toxicology studies required by this section
concerning human and domestic animal hazards should be carried
out as specified in Subdivision F of these guidelines or other
comparable protocols. Specifically, comparable studies
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conducted in accordance with the toxicology guidelines developed
by the Organization for Economic Cooperation and Development (OECD)
may also be used to meet the data requirements
of this section.
(b) Data requirements. The following toxicity data, with
respect to hazards to humans and domestic animals, shall be submitted
in an application for an experimental use permit:
(1) All uses. The following are required for all pesticides:
(i) Acute oral LD50 in one species (rat) for the end-use
product; refer to § 81-1 for required information;
(ii) Acute dermal LD50 in one species (rabbit) for the end-
use product; refer to § 81-2 for required information;
(iii) Primary dermal irritation in one spscies (rabbit) for
the end-use product; refer to § 81-5 for required information;
(iv) Primary eye irritation on one species (rabbit) for the
end-use product, if not strongly acidic or strongly alkaline, or if
not deemed corrosive or a severe irritant in dermal tests; refer to
§ 81-4 for required information; and
(v) Other conditional studies as required by paragraph (b)(3)
of this section.
(2) Food uses. The following are required where pesticide
application will result in the possibility of residues of the
pesticide occurring in or on food or feed items.
(i) When all food or feed treated under the permit will be
destroyed or used for research purposes, only the toxicity data
listed in paragraph (b)(l) of this section will be required.
(ii) When permits are acconpanied by a temporary tolerance,
food additive tolerance, or exemption from the requirement for a
tolerance, the following studies employing the technical grade of
each active ingredient in the pesticide product are required:
(A) Two 90-day or longer subchronic oral dosing studies;
refer to § 82-1 for required information. A no observed effect
level (NOEL) must be demonstrated for one rodent (rat) and one
nonrodent species;
(B) A teratology study; refer to § 83-3 for required
information;
(C) A battery of three mutagenicity studies to assess gene
mutation, chromosome aberrations, and primary DMA damage;
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(1) A gene mutation test in bacteria with and without
metabolic activation; refer to § 84-2(b) for required information;
(2) An in vivo mammalian cytogenetic test; refer to § 84-3{b)
for required information; and
(3^) An unscheduled DNA repair synthesis study in mammalian
cells with and without metabolic activation, or a sister-chromatid
exchange study in mammalian cells with and without metabolic acti-
vation; refer to § 84-4(c) or (e), respectively, for required
information.
(iii) In cases where the total cumulative theoretical maximal
residue contribution ("TMRC" i/) of all treated crop(s), including
contributions from all crops with established and pending tolerances
exceeds 50 percent of the maximal permitted intake ("MPI" 2/), the
following toxicology studies conducted with the technical material
of each active ingredient in the pesticide product shall ordinarily
be required..3/ These studies are in addition to those stated in
paragraph (b)(2)(ii) of this section:
(A) A one-year (or longer) interim report on a chronic
feeding study being performed in accordance with § 83-1. However,
it is not required that animals in this study be sacrificed for
the sole purpose of satisfying this requirement. Data reporting
and evaluation of the information in this report should be in the
format specified in § 83-1. This interim report should include
the following:
i/ "TMRC" is the amount of a chemical residue which is
calculated to remain in an "average" adult human diet. The
"average" diet weighs 1.5 kg and is composed of different food
items in an amount equal to the calculated average intake for each
food item. The TMRC calculation is based on the assumption that
each food item contains the maximum level of residue authorized by
existing and pending tolerances.
2/ "MPI" is the acceptable allowable daily intake (ADI) times
60 kg (average body weight of humans).
!/ The Agency realizes that the 50 percent limit does not take
into account all relevant factors for. all proposed experimental
uses, particularly those relating to exposure. The Agency, therefore,
intends to consider the 50 percent limit as a flexible guidepost
subject to reasonable variation on a case-by-case basis.
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(1) A complete description of the test substance, the protocol,
and the results of all observations and determinations made to date;
(2) All available data on gross observations, body weights,
food consumptions, hematology determinations, blood chemistry
determinations, and additional tests (if any);
(2) The results of any gross necropsies and available
histopathologic data from animals that died or were sacrificed
(due to moribundity and/or planned interim sacrifice); and
(B) A first generation (or longer) interim report on a
reproduction study being performed in accordance with § 83-4.
Data reporting and evaluation of the information in this report
should be in the format specified in § 83-4. This interim report
should include:
(1) A complete description of the test substance, the protocol,
and the results of all observations and determinations made to date;
(2_) All available data on gross observations, body weights,
maternal data, paternal data, litter data, and additional tests
(if any);
(3^) All data and reproductive indices up through weaning of
all FI generation animals; and
(j4) The results of any gross necropsies and available histo-
pathologic data from animals that died or were sacrificed (due to
moribund!ty and/or planned sacrifice).
(iv) A permit for a new formulation containing an active
ingredient which is registered and for which a permanent tolerance,
tolerance exemption, or food additive regulation has been established
for the proposed use need only be accompanied by the toxicology
data required under paragraph (b)(l) of this section. This provision
is based, however, on the assumption that the new formulation is to
be used in such a manner as to not result in residues in excess of
the established levels or not be contrary to the provisions for
specific tolerances in 40 CFR Part 180.
(3) Conditional test requirements. The permit application
must contain the following toxicity data if those data will be
required to support the registration of the pesticide product:
(i) Acute inhalation toxicity study on the end-use product;
refer to § 81-3 for required information;
(ii) Acute delayed neurotoxicity study on the technical grade
of each active ingredient in the end-use product; refer to § 81-7
for required information; and
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(iii) Dermal sensitization study on the end-use product; refer
to § 81-6 for required information.
(4) Inert ingredients. If application will result in the
possibility of residues occurring in or on food or feed, inert
ingredients in the formulated product(s) should be exempted from
the requirement of a tolerance (40 CFR 180.1001) unless all
food or feed treated under the experimental use permit will be
destroyed or used only for experimental research purposes. Inert
ingredients which have not been exempted will be handled on a
case-by-case basis.
§ 112-5 Data requirements concerning nontarget organism hazards.
(a) General. All toxicity studies required by this section
concerning hazards to nontarget organisms should be carried out as
specified under Subdivisions E, F, J, and L of these Guidelines
or other comparable protocols.
(b) Data requirements. In general, data on hazards to non-
target organisms are not required for indoor uses and those outdoor
uses not involving contact with nontarget organisms. Permit appli-
cation data requirements for pesticides whose outdoor uses involve
likely contact with nontarget organisms shall include the following:
(1) Mammal and bird studies. (i) Mammalian LD50 study;
this test is generally satisfied by the acute oral toxicity study
required by § 112-4(b)(l) of this subdivision, and described in
detail in § 81-1 of Subdivision F;
.(ii) Avian single dose oral LD50; refer to § 71-1 of
Subdivision E for required information;
(iii) Avian dietary LC50 study on two avian species; refer to
§ 71-2 for required information;
(iv) Fish acute LC50 study on both a cold and warm water
species; refer to § 72-1 for required information; and
(v) Acute toxicity to fresh water aquatic invertebrates;
refer to § 72-2 for required information.
(2) Nontarget insect studies. (i) Honey bee acute contact
LD50 study; refer to § 141-1 of Subdivision L for required information.
(ii) Acute toxicity to aquatic insects study; refer to § 142-1
for required information.
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§ 112-6 Product performance.
(a) General. In general, efficacy data will not be required
to support the issuance of an experimental use permit.
(b) Exceptions. (1) Initial permits. Efficacy data may be
required, on a case-by-case basis/ for the following use categories:
(i) Public health uses dealing with microscopic organisms; and
(ii) Use of cancelled or suspended pesticides.
(2) Extensions/ renewals, and amendments. Summaries of product
performance .data collected under an experimental use permit may
be requested on a case-by-case basis by the Agency for purposes of
making:
(i) Determinations as to the need for additional quantities
of product requested by the applicant;
(ii) Evaluations of requests for permit extensions; and
(iii) Assessments of requests for permit renewals.
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