[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2004 Edition]
[From the U.S. Government Printing Office]
[[Page i]]
40
Parts 150 to 189
Revised as of July 1, 2004
Protection of Environment
________________________
Containing a codification of documents of general
applicability and future effect
As of July 1, 2004
With Ancillaries
Published by
Office of the Federal Register
National Archives and Records
Administration
A Special Edition of the Federal Register
[[Page ii]]
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2004
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 40:
Chapter I--Environmental Protection Agency
(Continued) 3
Finding Aids:
Material Approved for Incorporation by Reference........ 583
Table of CFR Titles and Chapters........................ 585
Alphabetical List of Agencies Appearing in the CFR...... 603
List of CFR Sections Affected........................... 613
[[Page iv]]
----------------------------
Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 40 CFR 152.1 refers
to title 40, part 152,
section 1.
----------------------------
[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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To determine whether a Code volume has been amended since its
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EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
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of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in 11 separate
volumes. For the period beginning January 1, 2001, a ``List of CFR
Sections Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
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This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you find
the material is not available, please notify the Director of the Federal
Register, National Archives and Records Administration, Washington DC
20408, or call (202) 741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I). A list of CFR titles, chapters,
and parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ``Title 3--The President'' is carried within
that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ``Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
[[Page vii]]
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this
volume, contact the issuing agency. The issuing agency's name appears at
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Raymond A. Mosley,
Director,
Office of the Federal Register.
July 1, 2004.
[[Page ix]]
THIS TITLE
Title 40--Protection of Environment is composed of thirty volumes.
The parts in these volumes are arranged in the following order: parts 1-
49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-End), parts
53-59, part 60 (60.1-End), part 60 (Appendices), parts 61-62, part 63
(63.1-63.599), part 63 (63.600-1-63.1199), part 63 (63.1200-63.1439),
part 63 (63.1440-63.8830), part 63 (63.8980-End) parts 64-71, parts 72-
80, parts 81-85, part 86 (86.1-86.599-99) part 86 (86.600-1-End), parts
87-99, parts 100-135, parts 136-149, parts 150-189, parts 190-259, parts
260-265, parts 266-299, parts 300-399, parts 400-424, parts 425-699,
parts 700-789, and part 790 to End. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of July 1, 2004.
Chapter I--Environmental Protection Agency appears in all thirty
volumes. An alphabetical Listing of Pesticide Chemicals Index appears in
parts 150-189. Regulations issued by the Council on Environmental
Quality appear in the volume containing part 790 to End. The OMB control
numbers for title 40 appear in Sec. 9.1 of this chapter.
For this volume, Cheryl E. Sirofchuck was Chief Editor. The Code of
Federal Regulations publication program is under the direction of
Frances D. McDonald, assisted by Alomha S. Morris.
[[Page x]]
[[Page 1]]
TITLE 40--PROTECTION OF ENVIRONMENT
(This book contains parts 150 to 189)
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Part
chapter i--Environmental Protection Agency (Continued)...... 152
[[Page 3]]
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 65 FR
47324, 47325, Aug. 2, 2000, and at 66 FR 34375, 34376, June 28, 2001.
SUBCHAPTER E--PESTICIDE PROGRAMS
Part Page
150-151 [Reserved]
152 Pesticide registration and classification
procedures.............................. 5
153 Registration policies and interpretations... 43
154 Special review procedures................... 44
155 Registration standards...................... 52
156 Labeling requirements for pesticides and
devices................................. 55
157 Packaging requirements for pesticides and
devices................................. 73
158 Data requirements for registration.......... 78
159 Statements of policies and interpretations.. 131
160 Good laboratory practice standards.......... 144
162 State registration of pesticide products.... 156
163 Certification of usefulness of pesticide
chemicals............................... 164
164 Rules of practice governing hearings, under
the Federal Insecticide, Fungicide, and
Rodenticide Act, arising from refusals
to register, cancellations of
registrations, changes of
classifications, suspensions of
registrations and other hearings called
pursuant to section 6 of the Act........ 167
166 Exemption of Federal and State agencies for
use of pesticides under emergency
conditions.............................. 185
167 Registration of pesticide and active
ingredient producing establishments,
submission of pesticide reports......... 194
168 Statements of enforcement policies and
interpretations......................... 196
169 Books and records of pesticide production
and distribution........................ 207
170 Worker protection standard.................. 210
171 Certification of pesticide applicators...... 237
172 Experimental use permits.................... 254
[[Page 4]]
173 Procedures governing the rescission of State
primary enforcement responsibility for
pesticide use violations................ 270
174 Procedures and requirements for plant-
incorporated protectants................ 272
176 Time-limited tolerances for emergency
exemptions.............................. 277
177 Issuance of food additive regulations....... 279
178 Objections and requests for hearings........ 284
179 Formal evidentiary public hearing........... 288
180 Tolerances and exemptions from tolerances
for pesticide chemicals in food......... 300
181-189 [Reserved]
[[Page 5]]
SUBCHAPTER E_PESTICIDE PROGRAMS PARTS 150-151 [RESERVED]
PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES
--Table of Contents
Subpart A_General Provisions
Sec.
152.1 Scope.
152.3 Definitions.
152.5 Pests.
152.6 Substances excluded from regulation by FIFRA.
152.8 Products that are not pesticides because they are not for use
against pests.
152.10 Products that are not pesticides because they are not deemed to
be used for a pesticidal effect.
152.15 Pesticide products required to be registered.
Subpart B_Exemptions
152.20 Exemptions for pesticides regulated by another Federal agency.
152.25 Exemptions for pesticides of a character not requiring FIFRA
regulation.
152.30 Pesticides that may be transferred, sold, or distributed without
registration.
Subpart C_Registration Procedures
152.40 Who may apply.
152.42 Application for new registration.
152.43 Alternate formulations.
152.44 Application for amended registration.
152.46 Notification and non-notification changes to registrations.
152.50 Contents of application.
152.55 Where to send applications and correspondence.
Subpart D [Reserved]
Subpart E_Procedures To Ensure Protection of Data Submitters' Rights
152.80 General.
152.81 Applicability.
152.83 Definitions.
152.84 When materials must be submitted to the Agency.
152.85 Formulators' exemption.
152.86 The cite-all method.
152.90 The selective method.
152.91 Waiver of a data requirement.
152.92 Submission of a new valid study.
152.93 Citation of a previously submitted valid study.
152.94 Citation of a public literature study or study generated at
government expense.
152.95 Citation of all studies in the Agency's files pertinent to a
specific data requirement.
152.96 Documentation of a data gap.
152.97 Rights and obligations of data submitters.
152.98 Procedures for transfer of exclusive use or compensation rights
to another person.
152.99 Petitions to cancel registration.
Subpart F_Agency Review of Applications
152.100 Scope.
152.102 Publication.
152.104 Completeness of applications.
152.105 Incomplete applications.
152.107 Review of data.
152.108 Review of labeling.
152.110 Time for Agency review.
152.111 Choice of standards for review of applications.
152.112 Approval of registration under FIFRA sec. 3(c)(5).
152.113 Approval of registration under FIFRA sec. 3(c)(7)--Products that
do not contain a new active ingredient.
152.114 Approval of registration under FIFRA sec. 3(c)(7)--Products that
contain a new active ingredient.
152.115 Conditions of registration.
152.116 Notice of intent to register to original submitters of exclusive
use data.
152.117 Notification to applicant.
152.118 Denial of application.
152.119 Availability of material submitted in support of registration.
Subpart G_Obligations and Rights of Registrants
152.122 Currency of address of record and authorized agent.
152.125 Submission of information pertaining to adverse effects.
152.130 Distribution under approved labeling.
152.132 Supplemental distribution.
152.135 Transfer of registration.
Subpart H [Reserved]
Subpart I_Classification of Pesticides
152.160 Scope.
152.161 Definitions.
152.164 Classification procedures.
152.166 Labeling of restricted use products.
152.167 Distribution and sale of restricted use products.
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152.168 Advertising of restricted use products.
152.170 Criteria for restriction to use by certified applicators.
152.171 Restrictions other than those relating to use by certified
applicators.
152.175 Pesticides classified for restricted use.
Subparts J-T [Reserved]
Subpart U_Registration Fees
152.400 Purpose.
152.401 Inapplicability of fee provisions to applications filed prior to
October 1, 1997.
152.403 Definitions of fee categories.
152.404 Fee amounts.
152.406 Submission of supplementary data.
152.408 Special considerations.
152.410 Adjustment of fees.
152.412 Waivers and refunds.
152.414 Procedures.
Subparts V-Y [Reserved]
Subpart Z_Devices
152.500 Requirements for devices.
Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31
U.S.C. 9701.
Subpart A_General Provisions
Source: 53 FR 15975, May 4, 1988, unless otherwise noted.
Sec. 152.1 Scope.
Except as provided in part 174, part 152 sets forth procedures,
requirements, and criteria concerning the registration and
reregistration of pesticide products under FIFRA sec. 3, and for
associated regulatory activities affecting registration. These latter
regulatory activities include data compensation and exclusive use
(subpart E), and the classification of pesticide uses (subpart I). Part
152 also sets forth procedures, requirements, and criteria applicable to
plant-incorporated protectants. Unless specifically superceded by part
174, the regulations in part 152 apply to plant-incorporated
protectants.
[66 FR 37814, July 19, 2001]
Sec. 152.3 Definitions.
Terms used in this part have the same meaning as in the Act. In
addition, the following terms have the meanings set forth in this
section.
Act or FIFRA means the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended (7 U.S.C. 136-136y).
Active ingredient means any substance (or group of structurally
similar substances if specified by the Agency) that will prevent,
destroy, repel or mitigate any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA sec.
2(a), except as provided in Sec. 174.3 of this chapter.
Acute dermal LD50 means a statistically derived estimate
of the single dermal dose of a substance that would cause 50 percent
mortality to the test population under specified conditions.
Acute inhalation LC50 means a statistically derived
estimate of the concentration of a substance that would cause 50 percent
mortality to the test population under specified conditions.
Acute oral LD50 means a statistically derived estimate of
the single oral dose of a substance that would cause 50 percent
mortality to the test population under specified conditions.
Administrator means the Administrator of the United States
Environmental Protection Agency or his delegate.
Agency means the United States Environmental Protection Agency
(EPA), unless otherwise specified.
Applicant means a person who applies for a registration, amended
registration, or reregistration, under FIFRA sec. 3.
Biological control agent means any living organism applied to or
introduced into the environment that is intended to function as a
pesticide against another organism declared to be a pest by the
Administrator.
Distribute or sell and other grammatical variations of the term such
as ``distributed or sold'' and ``distribution or sale,'' means the acts
of distributing, selling, offering for sale, holding for sale, shipping,
holding for shipment, delivering for shipment, or receiving and (having
so received) delivering or offering to deliver, or releasing for
shipment to any person in any State.
End use product means a pesticide product whose labeling
(1) Includes directions for use of the product (as distributed or
sold, or after combination by the user with other
[[Page 7]]
substances) for controlling pests or defoliating, desiccating, or
regulating the growth of plants, and
(2) Does not state that the product may be used to manufacture or
formulate other pesticide products.
Final printed labeling means the label or labeling of the product
when distributed or sold. Final printed labeling does not include the
package of the product, unless the labeling is an integral part of the
package.
Genetic material necessary for the production means both: Genetic
material that encodes a substance or leads to the production of a
substance, and regulatory regions. It does not include noncoding,
nonexpressed nucleotide sequences.
In a living plant means inside the living plant, on the surface of
the living plant, or as an exudate from the living plant.
Inert ingredient means any substance (or group of structurally
similar substances if designated by the Agency), other than an active
ingredient, which is intentionally included in a pesticide product,
except as provided by Sec. 174.3 of this chapter.
Institutional use means any application of a pesticide in or around
any property or facility that functions to provide a service to the
general public or to public or private organizations, including but not
limited to:
(1) Hospitals and nursing homes.
(2) Schools other than preschools and day care facilities.
(3) Museums and libraries.
(4) Sports facilities.
(5) Office buildings.
Living plant means a plant, plant organ, or plant part that is
alive, viable, or dormant. Examples of plant parts include, but are not
limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
Manufacturing use product means any pesticide product that is not an
end-use product.
New use, when used with respect to a product containing a particular
active ingredient, means:
(1) Any proposed use pattern that would require the establishment
of, the increase in, or the exemption from the requirement of, a
tolerance or food additive regulation under section 408 or 409 of the
Federal Food, Drug and Cosmetic Act;
(2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if
no product containing the active ingredient is currently registered for
that use pattern; or
(3) Any additional use pattern that would result in a significant
increase in the level of exposure, or a change in the route of exposure,
to the active ingredient of man or other organisms.
Noncoding, nonexpressed nucleotide sequences means the nucleotide
sequences are not transcribed and are not involved in gene expression.
Examples of noncoding, nonexpressed nucleotide sequences include, but
are not limited to, linkers, adapters, homopolymers, and sequences of
restriction enzyme recognition sites.
Operated by the same producer, when used with respect to two
establishments, means that each such establishment is either owned by,
or leased for operation by and under the control of, the same person.
The term does not include establishments owned or operated by different
persons, regardless of contractural agreement between such persons.
Package or packaging means the immediate container or wrapping,
including any attached closure(s), in which the pesticide is contained
for distribution, sale, consumption, use, or storage. The term does not
include any shipping or bulk container used for transporting or
delivering the pesticide unless it is the only such package.
Pesticidal substance, when referring to a plant-incorporated
protectant only, means a substance that is intended to be produced and
used in a living plant, or in the produce thereof, for a pesticidal
purpose during any part of a plant's life cyle (e.g., in the embryo,
seed, seedling, mature plant).
Pesticide means any substance or mixture of substances intended for
preventing, destroying, repelling, or mitigating any pest, or intended
for use as a plant regulator, defoliant, or desiccant, other than any
article that:
(1) Is a new animal drug under FFDCA sec. 201(w), or
[[Page 8]]
(2) Is an animal drug that has been determined by regulation of the
Secretary of Health and Human Services not to be a new animal drug, or
(3) Is an animal feed under FFDCA sec. 201(x) that bears or contains
any substances described by paragraph (s) (1) or (2) of this section.
Pesticide product means a pesticide in the particular form
(including composition, packaging, and labeling) in which the pesticide
is, or is intended to be, distributed or sold. The term includes any
physical apparatus used to deliver or apply the pesticide if distributed
or sold with the pesticide.
Plant-incorporated protectant means a pesticidal substance that is
intended to be produced and used in a living plant, or in the produce
thereof, and the genetic material necessary for production of such a
pesticidal substance. It also includes any inert ingredient contained in
the plant, or produce thereof.
Produce thereof, when referring to plant-incorporated protectants
only, means a product of a living plant containing a plant-incorporated
protectant, where the pesticidal substance is intended to serve a
pesticidal purpose after the product has been separated from the living
plant. Examples of such products include, but are not limited to,
agricultural produce, grains, and lumber. Products such as raw
agricultural commodities bearing pesticide chemical residues are not
``produce thereof'' when the residues are not intended to serve a
pesticidal purpose in the produce.
Regulatory region means genetic material that controls the
expression of the genetic material that encodes a pesticidal substance
or leads to the production of a pesticidal substance. Examples of
regulatory regions include, but are not limited to, promoters,
enhancers, and terminators.
Residential use means use of a pesticide directly:
(1) On humans or pets,
(2) In, on, or around any structure, vehicle, article, surface, or
area associated with the household, including but not limited to areas
such as non-agricultural outbuildings, non-commercial greenhouses,
pleasure boats and recreational vehicles, or
(3) In any preschool or day care facility.
[53 FR 15975, May 4, 1988, as amended at 66 FR 37814, July 19, 2001]
Sec. 152.5 Pests.
An organism is declared to be a pest under circumstances that make
it deleterious to man or the environment, if it is:
(a) Any vertebrate animal other than man;
(b) Any invertebrate animal, including but not limited to, any
insect, other arthropod, nematode, or mollusk such as a slug and snail,
but excluding any internal parasite of living man or other living
animals;
(c) Any plant growing where not wanted, including any moss, alga,
liverwort, or other plant of any higher order, and any plant part such
as a root; or
(d) Any fungus, bacterium, virus, or other microorganisms, except
for those on or in living man or other living animals and those on or in
processed food or processed animal feed, beverages, drugs (as defined in
FFDCA sec. 201(g)(1)) and cosmetics (as defined in FFDCA sec. 201(i)).
Sec. 152.6 Substances excluded from regulation by FIFRA.
Products and substances listed in this section are excluded from
FIFRA regulation if they meet the specified conditions or criteria.
(a) Liquid chemical sterilants. A liquid chemical sterilant product
is not a pesticide under section 2(u) of FIFRA if it meets all of the
following criteria. Excluded products are regulated by the Food and Drug
Administration (FDA). Products excluded are those meeting all of the
following criteria:
(1) Composition. The product must be in liquid form as sold or
distributed. Pressurized gases or products in dry or semi-solid form are
not excluded by this provision. Ethylene oxide products are not liquid
products and are not excluded by this provision.
(2) Claims. The product must bear a sterilant claim, or a sterilant
plus subordinate level disinfection claim. Products that bear
antimicrobial claims solely at a level less than ``sterilant''
[[Page 9]]
are not excluded and are jointly regulated by EPA and FDA. ``Sterilant''
is defined in Sec. 156.441 of this chapter.
(3) Use site. (i) The product must be intended and labeled only for
use on ``critical or semi-critical devices.'' A ``critical device'' is
any device which is introduced directly into the human body, either into
or in contact with the bloodstream or normally sterile areas of the
body. A semi-critical device is any device which contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier or
otherwise enter normally sterile areas of the body.
(ii) Liquid chemical sterilants that bear claims solely for use on
non-critical medical devices are jointly regulated by EPA and FDA.
(iii) Liquid chemical sterilants that bear claims solely for use on
sites that are not medical devices, such as veterinary equipment, are
not excluded and are regulated solely by EPA.
(b) Nitrogen stabilizers. A nitrogen stabilizer is excluded from
regulation under FIFRA if it is a substance (or mixture of substances),
meeting all of the following criteria:
(1) The substance prevents or hinders the process of nitrification,
denitrification, ammonia volatilization, or urease production through
action affecting soil bacteria and is distributed and sold solely for
those purposes and no other pesticidal purposes. For purposes of this
section, living organisms are not considered to be substances, and the
actions of living organisms are not relevant to whether a substance is
deemed to be a nitrogen stabilizer.
(2) The substance was in ``commercial agronomic use'' in the United
States before January 1, 1992. EPA considers a substance to be in
commercial agronomic use if it is available for sale or distribution to
users for direct agronomic benefit, as opposed to limited research,
experimental or demonstration use.
(3) The substance was not registered under FIFRA before January 1,
1992.
(4) Since January 1, 1992, the distributor or seller has made no
claim that the product prevents or hinders the process of nitrification,
denitrification, ammonia volatilization or urease production. EPA
considers any of the following claims (or their equivalents) to be a
claim that the product prevents or hinders nitrification,
denitrification, ammonia volatilization or urease production:
(i) Improves crop utilization of applied nitrogen.
(ii) Reduces leaching of applied nitrogen or reduces groundwater
nitrogen contamination.
(iii) Prevents nitrogen loss.
(iv) Prolongs availability of nitrogen.
(v) Increases nitrogen uptake, availability, usage, or efficiency.
(5) A product will be considered to have met the criterion of
paragraph (b)(4) of this section that no nitrogen stabilization claim
has been made if:
(i) The nitrogen stabilization claim, in whatever terms expressed,
is made solely in compliance with a State requirement to include the
claim in materials required to be submitted to a State legislative or
regulatory authority, or in the labeling or other literature
accompanying the product; and
(ii) The State requirement to include the claim was in effect both
before the product bearing the claim was introduced into commercial
agronomic use, and before the effective date of this rule.
(6) A product that meets all of the criteria of this paragraph with
respect to one State is not thereby excluded from FIFRA regulation if
distributed and sold in another State whose nitrogen stabilization
statement requirement does not meet the requirements of paragraph
(b)(5)(ii) of this section.
(c) Human drugs. Fungi, bacteria, viruses or other microorganisms in
or on living man are not ``pests'' as defined in section 2(t) of FIFRA.
Products intended and labeled for use against such organisms are human
drugs subject to regulation by the FDA under the FFDCA.
(d) Animal drugs. (1) Fungi, viruses, bacteria or other
microorganisms on or in living animals are not ``pests'' under section
2(t) of FIFRA. Products intended for use against such organisms are
``animal drugs'' regulated by the FDA under the FFDCA.
(2) A ``new animal drug'' as defined in section 201(w) of the FFDCA,
or an animal drug that FDA has determined is
[[Page 10]]
not a ``new animal drug'' is not a pesticide under section 2(u) of
FIFRA. Animal drugs are regulated by the FDA under the FFDCA.
(e) Animal feeds. An animal feed containing a new animal drug is not
a pesticide under section 2(u) of FIFRA. An animal feed containing a new
animal drug is subject to regulation by the FDA under the FFDCA.
(f) Vitamin hormone products. A product consisting of a mixture of
plant hormones, plant nutrients, inoculants, or soil amendments is not a
``plant regulator'' under section 2(v) of FIFRA, provided it meets the
following criteria:
(1) The product, in the undiluted package concentration at which it
is distributed or sold, meets the criteria of Sec. 156.62 of this
chapter for Toxicity Category III or IV; and
(2) The product is not intended for use on food crop sites, and is
labeled accordingly.
(g) Products intended to aid the growth of desirable plants. A
product of any of the following types, intended only to aid the growth
of desirable plants, is not a ``plant regulator'' under section 2(v) of
FIFRA, and therefore is not a pesticide:
(1) A plant nutrient product, consisting of one or more
macronutrients or micronutrient trace elements necessary to normal
growth of plants and in a form readily usable by plants.
(2) A plant inoculant product consisting of microorganisms to be
applied to the plant or soil for the purpose of enhancing the
availability or uptake of plant nutrients through the root system.
(3) A soil amendment product containing a substance or substances
intended for the purpose of improving soil characteristics favorable for
plant growth.
[66 FR 64763, Dec. 14, 2001]
Sec. 152.8 Products that are not pesticides because they are not for use
against pests.
A substance or article is not a pesticide, because it is not
intended for use against ``pests'' as defined in Sec. 152.5, if it is:
(a) A fertilizer product not containing a pesticide.
(b) A product intended to force bees from hives for the collection
of honey crops.
[53 FR 15975, May 4, 1988, as amended at 66 FR 64764, Dec. 14, 2001]
Sec. 152.10 Products that are not pesticides because they are not deemed
to be used for a pesticidal effect.
A product that is not intended to prevent, destroy, repel, or
mitigate a pest, or to defoliate, desiccate or regulate the growth of
plants, is not considered to be a pesticide. The following types of
products or articles are not considered to be pesticides unless a
pesticidal claim is made on their labeling or in connection with their
sale and distribution:
(a) Deodorizers, bleaches, and cleaning agents;
(b) Products not containing toxicants, intended only to attract
pests for survey or detection purposes, and labeled accordingly;
(c) Products that are intended to exclude pests only by providing a
physical barrier against pest access, and which contain no toxicants,
such as certain pruning paints to trees.
Sec. 152.15 Pesticide products required to be registered.
No person may distribute or sell any pesticide product that is not
registered under the Act, except as provided in Sec. Sec. 152.20,
152.25, and 152.30. A pesticide is any substance (or mixture of
substances) intended for a pesticidal purpose, i.e., use for the purpose
of preventing, destroying, repelling, or mitigating any pest or use as a
plant regulator, defoliant, or desiccant. A substance is considered to
be intended for a pesticidal purpose, and thus to be a pesticide
requiring registration, if:
(a) The person who distributes or sells the substance claims,
states, or implies (by labeling or otherwise):
(1) That the substance (either by itself or in combination with any
other substance) can or should be used as a pesticide; or
(2) That the substance consists of or contains an active ingredient
and that it can be used to manufacture a pesticide; or
(b) The substance consists of or contains one or more active
ingredients
[[Page 11]]
and has no significant commercially valuable use as distributed or sold
other than (1) use for pesticidal purpose (by itself or in combination
with any other substance), (2) use for manufacture of a pesticide; or
(c) The person who distributes or sells the substance has actual or
constructive knowledge that the substance will be used, or is intended
to be used, for a pesticidal purpose.
Subpart B_Exemptions
Source: 53 FR 15977, May 4, 1988, unless otherwise noted.
Sec. 152.20 Exemptions for pesticides regulated by another Federal agency.
The pesticides or classes of pesticide listed in this section are
exempt from all requirements of FIFRA. The Agency has determined, in
accordance with FIFRA sec. 25(b)(1), that they are adequately regulated
by another Federal agency.
(a) Certain biological control agents. (1) Except as provided by
paragraphs (a)(3) and (a)(4) of this section, all biological control
agents are exempt from FIFRA requirements.
(2) If the Agency determines that an individual biological control
agent or class of biological control agents is no longer adequately
regulated by another Federal agency, and that it should not otherwise be
exempted from the requirements of FIFRA, the Agency will revoke this
exemption by amending paragraph (a)(3) of this section.
(3) The following biological control agents are not exempt from
FIFRA requirements:
(i) Eucaryotic microorganisms, including protozoa, algae and fungi;
(ii) Procaryotic microorganisms, including bacteria; and
(iii) Viruses.
(4) All living plants intended for use as biological control agents
are exempt from the requirements of FIFRA. However, plant-incorporated
protectants are not exempt pursuant to this section. Regulations,
including exemptions, for plant-incorporated protectants are addressed
in part 174 of this chapter.
(b) Non-liquid chemical sterilants. A non-liquid chemical sterilant,
except ethylene oxide, that meets the criteria of Sec. 152.6(a)(2) with
respect to its claims and Sec. 152.6(a)(3) with respect to its use
sites is exempted from regulation under FIFRA.
[53 FR 15977, May 4, 1988, as amended at 66 FR 37814, July 19, 2001; 66
FR 64764, Dec. 14, 2001]
Sec. 152.25 Exemptions for pesticides of a character not requiring FIFRA
regulation.
The pesticides or classes of pesticides listed in this section have
been determined to be of a character not requiring regulation under
FIFRA, and are therefore exempt from all provisions of FIFRA when
intended for use, and used, only in the manner specified.
(a) Treated articles or substances. An article or substance treated
with, or containing, a pesticide to protect the article or substance
itself (for example, paint treated with a pesticide to protect the paint
coating, or wood products treated to protect the wood against insect or
fungus infestation), if the pesticide is registered for such use.
(b) Pheromones and pheromone traps. Pheromones and identical or
substantially similar compounds labeled for use only in pheromone traps
(or labeled for use in a manner which the Administrator determines poses
no greater risk of adverse effects on the environment than use in
pheromone traps), and pheromone traps in which those compounds are the
sole active in gred i ent(s).
(1) For the purposes of this paragraph, a pheromone is a compound
produced by an arthropod which, alone or in combination with other such
compounds, modifies the behavior of other individuals of the same
species.
(2) For the purposes of this paragraph, a synthetically produced com
pound is identical to a pheromone only when their molecular structures
are identical, or when the only differences between the molecular
structures are between the stereochemical isomer ratios of the two
compounds, except that a synthetic compound found to have toxicological
properties significantly different from a pher o mone is not identical.
(3) When a compound possesses many characteristics of a pheromone
but
[[Page 12]]
does not meet the criteria in paragraph (a)(2) of this section, it may,
after review by the Agency, be deemed a substantially similar compound.
(4) For the purposes of this paragraph, a pheromone trap is a device
containing a pheromone or an identical or substantially similar compound
used for the sole purpose of attracting, and trapping or killing, target
arthropods. Pheromone traps are intended to achieve pest control by
removal of target organisms from their natural environment and do not
result in increased levels of pheromones or identical or substantially
similar compounds over a significant fraction of the treated area.
(c) Preservatives for biological specimens. (1) Embalming fluids.
(2) Products used to preserve animal or animal organ specimens, in
mortuaries, laboratories, hospitals, museums and institutions of
learning.
(3) Products used to preserve the integrity of milk, urine, blood,
or other body fluids for laboratory analysis.
(d) Foods. Products consisting of foods and containing no active
ingredients, which are used to attract pests.
(e) Natural cedar. (1) Natural cedar blocks, chips, shavings, balls,
chests, drawer liners, paneling, and needles that meet all of the
following criteria:
(i) The product consists totally of cedarwood or natural cedar.
(ii) The product is not treated, combined, or impregnated with any
additional substance(s).
(iii) The product bears claims or directions for use solely to repel
arthropods other than ticks or to retard mildew, and no additional
claims are made in sale or distribution. The labeling must be limited to
specific arthropods, or must exclude ticks if any general term such as
``arthropods,'' ``insects,'' ``bugs,'' or any other broad inclusive
term, is used. The exemption does not apply to natural cedar products
claimed to repel ticks.
(2) The exemption does not apply to cedar oil, or formulated
products which contain cedar oil, other cedar extracts, or ground cedar
wood as part of a mixture.
(f) Minimum risk pesticides--(1) Exempted products. Products
containing the following active ingredients are exempt from the
requirements of FIFRA, alone or in combination with other substances
listed in this paragraph, provided that all of the criteria of this
section are met.
Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon and cinnamon oil
Citric acid
Citronella and citronella oil
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic and garlic oil
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant) and sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc metal and impurities)
(2) Permitted inerts. A pesticide product exempt under paragraph
(g)(1) of this section may only include inert ingredients listed in the
most current List 4A. This list is updated periodically and is published
in the Federal Register. The most current list may be obtained by
writing to Registration Support Branch (4A Inerts List) Registration
Division (7505C), Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
(3) Other conditions of exemption. All of the following conditions
must be met for products to be exempted under this section:
(i) Each product containing the substance must bear a label
identifying the name and percentage (by weight) of each active
ingredient and the name of each inert ingredient.
[[Page 13]]
(ii) The product must not bear claims either to control or mitigate
microorganisms that pose a threat to human health, including but not
limited to disease transmitting bacteria or viruses, or claims to
control insects or rodents carrying specific diseases, including, but
not limited to ticks that carry Lyme disease.
(iii) The product must not include any false and misleading labeling
statements, including those listed in 40 CFR 156.10(a)(5)(i) through
(viii).
[53 FR 15977, May 4, 1988, as amended at 59 FR 2751, Jan. 19, 1994; 61
FR 8878, Mar. 6, 1996; 66 FR 64764, Dec. 14, 2001]
Sec. 152.30 Pesticides that may be transferred, sold, or distributed
without registration.
An unregistered pesticide, or a pesticide whose registration has
been cancelled or suspended, may be dis-tributed or sold, or otherwise
transferred, to the extent described by this section.
(a) A pesticide transferred between registered establishments
operated by the same producer. An unregistered pesticide may be
transferred between registered establishments operated by the same
producer. The pesticide as transferred must be labeled in accordance
with part 156 of this chapter.
(b) A pesticide transferred between registered establishments not
operated by the same producer. An unregistered pesticide may be
transferred between registered establishments not operated by the same
producer if:
(1) The transfer is solely for the purpose of further formulation,
packaging, or labeling into a product that is registered;
(2) Each active ingredient in the pesticide, at the time of
transfer, is present as a result of incorporation into the pesticide of
either:
(i) A registered product; or
(ii) A pesticide that is produced by the registrant of the final
product; and
(3) The product as transferred is labeled in accordance with part
156 of this chapter.
(c) A pesticide distributed or sold under an experimental use
permit. (1) An unregistered pesticide may be distributed or sold in
accordance with the terms of an experimental use permit issued under
FIFRA sec. 5, if the product is labeled in accordance with Sec. 172.6
of this chapter.
(2) An unregistered pesticide may be distributed or sold in
accordance with the provisions of Sec. 172.3 of this chapter,
pertaining to use of a pesticide for which an experimental use permit is
not required, provided the product is labeled in accordance with part
156 of this chapter.
(d) A pesticide transferred solely for export. An unregistered
pesticide may be transferred within the United States solely for export
if it meets the following conditions:
(1) The product is prepared and packaged according to the
specifications of the foreign purchaser; and
(2) The product is labeled in accordance with part 156 of this
chapter.
(e) A pesticide distributed or sold under an emergency exemption. An
unregistered pesticide may be distributed or sold in accordance with the
terms of an emergency exemption under FIFRA sec. 18, if the product is
labeled in accordance with part 156 of this chapter.
(f) A pesticide transferred for purposes of disposal. An
unregistered, suspended, or cancelled pesticide may be transferred
solely for disposal in accordance with FIFRA sec. 19 or an applicable
Administrator's order. The product must be labeled in accordance with
part 156 of this chapter.
(g) Existing stocks of a formerly registered product. A cancelled or
suspended pesticide may be distributed or sold to the extent and in the
manner specified in an order issued by the Administrator concerning
existing stocks of the pecticide.
Subpart C_Registration Procedures
Source: 53 FR 15978, May 4, 1988, unless otherwise noted.
Sec. 152.40 Who may apply.
Any person may apply for new registration of a pesticide product.
Any registrant may apply for amendment of the registration of his
product.
[[Page 14]]
Sec. 152.42 Application for new registration.
Any person seeking to obtain a registration for a new pesticide
product must submit an application for registration, containing the
information specified in Sec. 152.50. An application for new
registration must be approved by the Agency before the product may
legally be distributed or sold, except as provided by Sec. 152.30.
Sec. 152.43 Alternate formulations.
(a) A product proposed for registration must have a single, defined
composition, except that EPA may approve a basic formulation and one or
more alternate formulations for a single product.
(b) An alternate formulation must meet the criteria listed in
paragraph (b) (1) through (4) of this section. The Agency may require
the submission of data to determine whether the criteria have been met.
(1) The alternate formulation must have the same certified limits
for each active ingredient as the basic formulation.
(2) If the alternate formulation contains an inert ingredient or
impurity of toxicological signficance, the formulation must have the
same upper certified limit for that substance as the basic formulation;
(3) The label text of the alternate formulation product must be
identical to that of the basic formulation.
(4) The analytical method required under Sec. 158.180 must be
suitable for use on both the basic formulation and the alternate
formulation.
(c) Notwithstanding the criteria in this section, the Agency may
determine that an alternate formulation must be separately registered.
If EPA makes this determination, the Agency will notify the applicant of
its determination and its reasons. Thereafter the application for an
alternate formulation will be treated as an application for new
registration, and the alternate formulation will be assigned a new
registration number.
Sec. 152.44 Application for amended registration.
(a) Except as provided by Sec. 152.46, any modification in the
composition, labeling, or packaging of a registered product must be
submitted with an application for amended registration. The applicant
must submit the information required by Sec. 152.50, as applicable to
the change requested. If an application for amended registration is
required, the application must be approved by the Agency before the
product, as modified, may legally be distributed or sold.
(b) In its discretion, the Agency may:
(1) Waive the requirement for submission of an application for
amended registration;
(2) Require that the applicant certify to the Agency that he has
complied with an Agency directive rather than submit an application for
amended registration; or
(3) Permit an applicant to modify a registration by notification or
non-notification in accordance with Sec. 152.46.
(c) A registrant may at any time submit identical minor labeling
amendments affecting a number of products as a single application if no
data are required for EPA to approve the amendment (for example, a
change in the wording of a storage statement for designated residential
use products). A consolidated application must clearly identify the
labeling modification(s) to be made (which must be identical for all
products included in the application), list the registration number of
each product for which the modification is requested, and provide
required supporting materials (for example, labeling) for each affected
product.
[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996; 66
FR 64764, Dec. 14, 2001]
Sec. 152.46 Notification and non-notification changes to registrations.
(a) Changes permitted by notification. (1) EPA may determine that
certain minor modifications to registration having no potential to cause
unreasonable adverse effects to the environment may be accomplished by
notification to the Agency, without requiring that the registrant obtain
Agency approval. If EPA so determines, it will issue procedures
following an opportunity for public comment describing the types of
modifications permitted by notification and any conditions and
procedures for submitting notifications.
[[Page 15]]
(2) A registrant may modify a registration consistent with paragraph
(a)(1) of this section and any procedures issued thereunder and
distribute or sell the modified product as soon as the Agency has
received the notification. Based upon the notification, the Agency may
require that the registrant submit an application for amended
registration. If it does so, the Agency will notify the registrant and
state its reasons for requiring an application for amended registration.
Thereafter, if the registrant fails to submit an application the Agency
may determine that the product is not in compliance with the
requirements of the Act. Notification under this paragraph is considered
a report filed under the Act for the purposes of FIFRA section
12(a)(2)(M).
(b) Changes permitted without notification. EPA may determine that
certain minor modifications to registration having no potential to cause
unreasonable adverse effects to the environment may be accomplished
without notification to or approval by the Agency. If EPA so determines,
it will issue procedures following an opportunity for public comment
describing the types of amendments permitted without notification (also
known as non-notification). A registrant may distribute or sell a
product changed in a manner consistent with such procedures without
notification to or approval by the Agency.
(c) Effect of non-compliance. Notwithstanding any other provision of
this section, if the Agency determines that a product has been modified
through notification or without notification in a manner inconsistent
with paragraphs (a) or (b) of this section and any procedures issued
thereunder, the Agency may initiate regulatory and/or enforcement action
without first providing the registrant with an opportunity to submit an
application for amended registration.
[61 FR 33041, June 26, 1996]
Sec. 152.50 Contents of application.
Each application for registration or amended registration must
include the following information, as applicable:
(a) Application form. An application form must be completed and
submitted to the Agency. Application forms are provided by the Agency,
with instructions as to the number of copies required and proper
completion.
(b) Identity of the applicant--(1) Name. The applicant must identify
himself. An applicant not residing in the United States must also
designate an agent in accordance with paragraph (b)(3) of this section
to act on behalf of the applicant on all registration matters.
(2) Address of record. The applicant must provide an address in the
United States for correspondence purposes. The U.S. address provided
will be considered the applicant's address of record, and EPA will send
all correspondence concerning the application and any subsequent
registration to that address. It is the responsibility of the applicant
and any registrant under Sec. 152.122 to ensure that the Agency has a
current and accurate address.
(3) Authorized agent. An applicant may designate a person residing
in the United States to act as his agent. If an applicant wishes to
designate an agent, he must send the Agency a letter stating the name
and United States address of his agent. The applicant must notify the
Agency if he changes his designated agent. This relationship may be
terminated at any time by the applicant by notifying the Agency in
writing.
(4) Company number. If an applicant has been assigned a company
number by the Agency, the application must reference that number.
(c) Summary of the application. Each application must include a list
of the data submitted with the application, together with a brief
description of the results of the studies. The list of data submitted
may be the same as the list required by Sec. 158.32 of this chapter.
The summary must state that is is releasable to the public after
registration in accordance with Sec. 152.119.
(d) Identity of the product. The product for which application is
being submitted must be identified. The following information is
required:
(1) The product name;
(2) The trade name(s) (if different); and
(3) The EPA Registration Number, if currently registered.
[[Page 16]]
(e) Draft labeling. Each application for new registration must be
accompanied by five legible copies of draft labeling (typescript or
mock-up). Each application for amended registration that proposes to
make any changes in the product labeling must be accompanied by five
legible copies of draft labeling incorporating the proposed labeling
changes. If the proposed labeling change affects only a portion of the
labeling, such as the use directions, the applicant may submit five
copies of that portion of the label which is the subject of the
amendment. Upon request, an applicant for amended registration must
submit a complete label to consolidate amendments.
(f) Registration data requirements. (1) An applicant must submit
materials to demonstrate that he has complied with the FIFRA sec.
3(c)(1)(D) and subpart E of this part with respect to satisfaction of
data requirements, to enable the Agency to make the determination
required by FIFRA sec. 3(c)(5)(B). Required items are described in
subpart E of this part.
(2) An applicant must furnish any data specified in part 158 of this
chapter which are required by the Agency to determine that the product
meets the registration standards of FIFRA sec. 3(c) (5) or (7). Each
study must comply with:
(i) Section 158.30 of this chapter, with respect to times for
submission;
(ii) Section 158.32 of this chapter, with respect to format of
submission;
(iii) Section 158.33 of this chapter, with respect to studies for
which a claim of trade secret or confidential business information is
made;
(iv) Section 158.34 of this chapter, with respect to flagging for
potential adverse effects; and
(v) Section 160.12 of this chapter, if applicable, with respect to a
statement of whether studies were conducted in accordance with the Good
Laboratory Practices of part 160.
(3) An applicant shall furnish with his application any factual
information of which he is aware regarding unreasonable adverse effects
of the pesticide on man or the environment, which would be required to
be reported under FIFRA sec. 6(a)(2) if the product were registered.
(g) Certification relating to child-resistant packaging. If the
product meets the criteria for child-resistant packaging, the applicant
must submit a certification that the product will be distributed or sold
only in child-resistant packaging. Refer to part 157 of this chapter for
the criteria and certification requirements.
(h) Request for classification. If an applicant wishes to request a
classification different from that established by the Agency, he must
submit a request for such classification and information supporting the
request.
(i) Statement concerning tolerances. If the proposed labeling bears
instructions for use of the pesticide on food or feed crops, or if the
intended use of the pesticide results or may be expected to result,
directly or indirectly, in pesticide residues in or on food or feed
(including residues of any active ingredient, inert ingredient,
metabolite, or degradation product), the applicant must submit a
statement indicating whether such residues are authorized by a
tolerance, exemption from the requirement of a tolerance, or food
additive regulation issued under section 408 or 409 of the Federal Food,
Drug and Cosmetic Act (FFDCA). If such residues have not been
authorized, the application must be accompanied by a petition for
establishment of appropriate tolerances, exemptions from the requirement
of a tolerance, or food additive regulations, in accordance with part
180 of this chapter.
[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60
FR 32096, June 19, 1995]
Sec. 152.55 Where to send applications and correspondence.
Applications and correspondence relating to registration should be
mailed to the Registration Division (7505C), U.S. Environmental
Protection Agency, Washington, DC 20460. Persons who wish to hand-
deliver applications should contact the Registration Division to
determine the location for delivery.
[53 FR 15978, May 4, 1988, as amended at 69 FR 39864, July 1, 2004]
Subpart D [Reserved]
[[Page 17]]
Subpart E_Procedures To Ensure Protection of Data Submitters' Rights
Source: 49 FR 30903, Aug. 1, 1984, unless otherwise noted.
Sec. 152.80 General.
This subpart E (Sec. Sec. 152.80 through 152.119)\1\ describes the
information that an applicant must submit with his application for
registration, amended registration, or reregistration to comply (and for
the Agency to determine compliance) with the provisions of FIFRA section
3(c)(1)(D). This subpart also describes the procedures by which data
submitters may challenge registration actions which allegedly failed to
comply with these procedures. If the Agency determines that an applicant
has failed to comply with the requirements and procedures in this
subpart, the application may be denied. If the Agency determines, after
registration has been issued, that an applicant failed to comply with
these procedures and requirements, the Agency may issue a notice of
intent to cancel the product's registration.
---------------------------------------------------------------------------
\1\ Editorial Note: Sections 152.116 and 152.119 were transferred to
subpart F at 53 FR 15980, May 4, 1988.
[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993]
Sec. 152.81 Applicability.
(a) Except as provided in paragraph (b) of this section, Sec. Sec.
152.83 through 152.119 apply to:
(1) Each application for registration of a new product;
(2) Each application for an amendment of a registration; and
(3) Each application for reregistration under FIFRA section 3(g).
(b) This subpart E does not apply to:
(1) Applications for registration submitted to States under FIFRA
section 24(c);
(2) Applications for experimental use permits under FIFRA section 5;
(3) Applications for emergency exemptions under FIFRA section 18;
(4) Applications to make only one or more of the following types of
amendments to existing registrations, unless the Administrator or his
designee finds that Agency consideration of scientific data would be
necessary in order to approve the amendment under FIFRA section 3(c)(5):
(i) An increase or decrease in the percentage in the product of one
or more of its active ingredients or deliberately added inert
ingredients;
(ii) A revision of the identity or amount of impurities present in
the product;
(iii) The addition or deletion of one or more deliberately added
inert ingredients;
(iv) The deletion of one or more active ingredients;
(v) A change in the source of supply of one or more of the active
ingredients used in the product, if the new source of the active
ingredient is a product which is registered under FIFRA section 3;
(vi) Deletion of approved uses of claims;
(vii) Redesign of the label format involving no substantive changes,
express or implied, in the directions for use, claims, representations,
or precautionary statements;
(viii) Change in the product name or addition of an additional brand
name, if no additional claims, representations, or uses are expressed or
implied by the changes;
(ix) Clarification of directions for use;
(x) Correction of typographical errors;
(xi) Changes in the registrant's name or address;
(xii) Adding or deleting supplemental registrants;
(xiii) Changes in the package or container size;
(xiv) Changes in warranty, warranty disclaimer, or liability
limitation statements, or addition to or deletion of such statements;
(xv) ``Splitting'' a label for the sole purpose of facilitating the
marketing of a product in different geographic regions with appropriate
labels, where each amended label will contain previously approved use
instructions (and related label statements) appropriate to a particular
geographic region;
[[Page 18]]
(xvi) Any other type of amendment, if the Administrator or his
designee determines, by written finding, that the Agency consideration
of scientific data would not be necessary in order to approve the
amendment under FIFRA section 3(c)(5); and
(xvii) Compliance with Agency Regulations, adjudicatory hearing
decisions, notices, or other Agency announcements that unless the
registration is amended in the manner the Agency proposes, the product's
registration will be suspended or cancelled, or that a hearing will be
held under FIFRA section 6. (However, this paragraph does not apply to
amendments designed to avoid cancellation or suspension threatened under
FIFRA section 3(c)(2)(B) or because of failure to submit data.)
Sec. 152.83 Definitions.
As used in this subpart, the following terms shall have the meanings
set forth in this section:
(a) Data gap means the absence of any valid study or studies in the
Agency's files which would satisfy a specific data requirement for a
particular pesticide product.
(b) Data Submitters List means the current Agency list, entitled
``Pesticide Data Submitters by Chemical,'' of persons who have submitted
data to the Agency.
(c) Exclusive use study means a study that meets each of the
following requirements:
(1) The study pertains to a new active ingredient (new chemical) or
new combination of active ingredients (new combination) first registered
after September 30, 1978;
(2) The study was submitted in support of, or as a condition of
approval of, the application resulting in the first registration of a
product containing such new chemical or new combination (first
registration), or an application to amend such registration to add a new
use; and
(3) The study was not submitted to satisfy a data requirement
imposed under FIFRA section 3(c)(2)(B);
Provided that, a study is an exclusive use study only during the 10-
year period following the date of the first registration.
(d) Original data submitter means the person who possesses all
rights to exclusive use or compensation under FIFRA section 3(c)(1)(D)
in a study originally submitted in support of an application for
registration, amended registration, reregistration, or experimental use
permit, or to maintain an existing registration in effect. The term
includes the person who originally submitted the study, any person to
whom the rights under FIFRA section 3(c)(1)(D) have been transferred, or
the authorized representative of a group of joint data developers.
(e) Valid study means a study that has been conducted in accordance
with the Good Laboratory Practice standards of 40 CFR part 160 or
generally accepted scientific methodology and that EPA has not
determined to be invalid.
Sec. 152.84 When materials must be submitted to the Agency.
All information required by this subpart should be submitted with
the application, but may be submitted at any later time prior to EPA's
approval of the application. The Agency will not approve any application
until it determines either that the application is not subject to these
requirements or that all required materials have been submitted and are
acceptable.
Sec. 152.85 Formulators' exemption.
(a) FIFRA section 3(c)(2)(D) excuses an applicant from the
requirement to submit or cite data pertaining to the safety of any
ingredient (or mixture of ingredients) contained in his product that is
derived solely from one or more EPA-registered products which the
applicant purchases from another producer.
(b) If the product contains one or more ingredients eligible for the
formulators' exemption, the applicant need not comply with the
requirements of Sec. Sec. 152.90 through 152.96 with respect to any
data requirements pertaining to the safety of any such ingredient,
provided that he submits to the Agency a certification statement
containing the following information (a form for this purpose is
available from the Agency):
(1) Identification of the applicant, and of the product by EPA
registration number or file symbol;
[[Page 19]]
(2) Identification of each ingredient in the pesticide that is
eligible for the formulators' exemption, and the EPA registration number
of the product that is the source of that ingredient;
(3) A statement that the listed ingredients meet the requirements
for the formulators' exemption;
(4) A statement that the applicant has submitted (either previously
or with the current application) a complete, accurate and current
Confidential Statement of Formula; and
(5) The name, title and signature of the applicant or his authorized
representative and the date of signature.
(c) An applicant for amended registration is not required to submit
a new formulators' exemption statement, if the current statement in
Agency files is complete and accurate.
[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993; 60
FR 32096, June 19, 1995]
Sec. 152.86 The cite-all method.
An applicant may comply with this subpart by citing all data in
Agency files that are pertinent to its consideration of the requested
registration under FIFRA section 3(c)(5), in accordance with the
procedures in this section, as applicable.
(a) Exclusive use studies. The applicant must certify to the Agency
that he has obtained, from each person listed on the Data Submitters
List as an exclusive use data submitter for the chemical in question, a
written authorization that contains at least the following information:
(1) Identification of the applicant to whom the authorization is
granted;
(2) Authorization to the applicant to use all pertinent studies in
satisfaction of data requirements for the application in question; and
(3) The signature and title of the original data submitter or his
authorized representative and date of the authorization.
If the Agency identifies any exclusive use data submitter not on the
Data Submitters List, the applicant will be required prior to
registration to obtain the necessary written authorization from such
person.
(b) Other studies. The applicant must certify to the Agency that,
with respect to each other person on the Data Submitters List for the
chemical in question:
(1) He has obtained from that person a written authorization that
contains the information required by paragraphs (a) (1) through (3) of
this section; or
(2) He has furnished to that person:
(i) A notification of his intent to apply for registration,
including the name of the proposed product, and a list of the product's
active ingredients;
(ii) An offer to pay the person compensation to the extent required
by FIFRA section 3(c)(1)(D) for any data on which the application
relies;
(iii) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be paid for the use of any study; and
(iv) His name, address and telephone number.
(c) General offer to pay statement. The applicant must submit to the
Agency the following general offer to pay statement:
[Name of applicant] hereby offers and agrees to pay compensation to
other persons, with regard to the approval of this application, to the
extent required by FIFRA section 3(c)(1)(D) of the Federal Insecticide,
Fungicide and Rodenticide Act.
(d) Acknowledgement of reliance on data. Each application filed
under this section shall include an acknowledgement that for purposes of
FIFRA section 3(c)(1)(D) the application relies on the following data:
(1) All data submitted with or specifically cited in the
application; and
(2) Each other item of data in the Agency's files which:
(i) Concerns the properties or effects of the applicant's product,
of any product which is identical or substantially similar to the
applicant's product, or of one or more of the active ingredients in the
applicant's product; and
(ii) Is one of the types of data that EPA would require to be
submitted if the application sought the initial registration under FIFRA
section 3(c)(5) of a product with composition and intended uses
identical or substantially similar to the applicant's product, under the
data requirements in effect on the date EPA approves the applicant's
present application.
[[Page 20]]
Sec. 152.90 The selective method.
An applicant may comply with this subpart by listing the specific
data requirements that apply to his product, its active ingredients, and
use patterns, and demonstrating his compliance for each data requirement
by submitting or citing individual studies, or by demonstrating that no
study has previously been submitted to the Agency. This section
summarizes the procedures that an applicant must follow if he chooses
the selective method of demonstrating compliance. Sections 152.91
through 152.96 contain specific procedures for citing or submitting a
study or demonstrating a data gap.
(a) List of data requirements. Each applicant must submit a list of
the data requirements that would apply to his pesticide, its active
ingredients, and its use patterns, if the product were being proposed
for registration under FIFRA section 3(c)(5) for the first time. The
applicant need not list data requirements pertaining to any ingredient
which qualifies for the formulator's exemption.
(1) If a Registration Standard has been issued for any active
ingredient, the applicant must list the applicable data requirements
enumerated in that Standard for the active ingredient and, if end use
products are covered by the Registration Standard, for such products
containing that active ingredient.
(2) If a Registration Standard has not been issued, or if an issued
Registration Standard does not cover all data requirements for products
containing the active ingredient in question, the applicant must list
the applicable requirements as prescribed by 40 CFR part 158. All
required (R) studies, and any studies that could be conditionally
required (CR) based upon composition, use pattern, or the results of
required studies, are to be listed. The applicant may demonstrate via
the data gap procedures in Sec. 152.96 that a conditional requirement
need not be satisfied by the submission or citation of data at the time
of application.
(b) Methods of demonstrating compliance. The applicant must state
for each data requirement on the list required by paragraph (a) of this
section which of the following methods of compliance with the
requirement he is using, and shall provide the supporting documentation
specified in the referenced section.
(1) Existence of or granting of a data waiver. Refer to Sec.
152.91.
(2) Submission of a new valid study. Refer to Sec. 152.92.
(3) Citation of a specific valid study previously submitted to the
Agency by the applicant or another person, with any necessary written
authorizations or offers to pay. Refer to Sec. 152.93.
(4) Citation of a public literature study. Refer to Sec. 152.94.
(5) Citation of all pertinent studies previously submitted to the
Agency, with any necessary written authorizations or offers to pay.
Refer to Sec. 152.95.
(6) Documentation of a data gap. Refer to Sec. 152.96.
Sec. 152.91 Waiver of a data requirement.
The applicant may demonstrate compliance for a data requirement by
documenting the existence of a waiver in accordance with paragraph (a)
of this section, or by being granted a new waiver requested in
accordance with paragraph (b) of this section.
(a) Request for extension of an existing waiver. An applicant may
claim that a waiver previously granted by the Agency also applies to a
data requirement for his product. To document this claim, the applicant
must provide a reference to the Agency record that describes the
previously granted waiver, such as an Agency list of waivers or an
applicable Registration Standard, and must explain why that waiver
should apply to his product.
(b) Request for a new waiver. An applicant who requests a waiver to
satisfy a data requirement must submit the information specified in 40
CFR 158.45.
(c) Effect of denial of waiver request. If the request for a new
waiver or extension of an existing waiver is denied by the Agency, the
applicant must choose another method of satisfying the data requirement.
Sec. 152.92 Submission of a new valid study.
An applicant may demonstrate compliance for a data requirement by
submitting a valid study that has not previously been submitted to the
Agency. A study previously submitted to the
[[Page 21]]
Agency should not be resubmitted but should be cited in accordance with
Sec. 152.93.
Sec. 152.93 Citation of a previously submitted valid study.
An applicant may demonstrate compliance for a data requirement by
citing a valid study previously submitted to the Agency. The study is
not to be submitted to the Agency with the application.
(a) Study originally submitted by the applicant. If the applicant
certifies that he is the original data submitter, no documentation other
than the citation is necessary.
(b) Study previously submitted by another person. If the applicant
is not the original data submitter, the applicant may cite the study
only in accordance with paragraphs (b) (1) through (3) of this section.
(1) Citation with authorization of original data submitter. The
applicant may cite any valid study for which he has obtained the written
authorization of the original data submitter. The applicant must obtain
written authorization to cite any study that is an exclusive use study.
The applicant must certify that he has obtained from the original data
submitter a written authorization that contains at least the following
information:
(i) Identification of the applicant to whom the authorization is
granted;
(ii) Identification by title, EPA Accession Number or Master Record
Identification Number, and date of submission, of the study or studies
for which the authorization is granted;
(iii) Authorization to the applicant to use the specified study in
satisfaction of the data requirement for the application in question;
and
(iv) The signature and title of the original data submitter or his
authorized representative, and date of the authorization.
(2) Citation with offer to pay compensation to the original data
submitter. The applicant may cite any valid study that is not subject to
the exclusive use provisions of FIFRA section 3(c)(1)(D)(i) without
written authorization from the original data submitter if the applicant
certifies to the Agency that he has furnished to the original data
submitter:
(i) A notification of the applicant's intent to apply for
registration, including the proposed product name and a list of the
product's active ingredients;
(ii) Identification of the specific data requirement involved and of
the study for which the offer to pay is made (by title, EPA Accession
Number or Master Record Identification Number, and date of submission,
if possible);
(iii) An offer to pay the person compensation to the extent required
by FIFRA section 3(c)(1)(D);
(iv) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be paid for the use of the study; and
(v) The applicant's name, address and telephone number.
(3) Citation without authorization or offer to pay. The applicant
may cite any valid study without written authorization from, or offer to
pay to, the original data submitter, if:
(i) The study was originally submitted to the Agency on or before
December 31, 1969; or
(ii) The study was originally submitted to the Agency on or before
the date that is 15 years before the date of the application for which
it is cited, and the study is not an exclusive use study, as defined in
Sec. 152.83(c).
Sec. 152.94 Citation of a public literature study or study generated at
government expense.
(a) An applicant may demonstrate compliance for a data requirement
by citing, and submitting to the Agency, one of the following:
(1) A valid study from the public literature.
(2) A valid study generated by, or at the expense of, any government
(Federal, State, or local) agency.
(b) In no circumstances does submission of a public literature study
or government-generated study confer any rights on the data submitter to
exclusive use of data or compensation under FIFRA section 3(c)(1)(D).
[[Page 22]]
Sec. 152.95 Citation of all studies in the Agency's files pertinent to a
specific data requirement.
An applicant normally may demonstrate compliance for a data
requirement by citation of all studies in the Agency's files pertinent
of that data requirement. The applicant who selects this cite-all option
must submit to the Agency:
(a) A general offer to pay statement having the same wording as that
specified in Sec. 152.86(c) except that the offer to pay may be limited
to apply only to data pertinent to the specific data requirement(s) for
which the cite-all method of support has been selected;
(b) A certification that:
(1) For each person who is included on the Data Submitters List as
an original data submitter of exclusive use data for the active
ingredient in question, the applicant has obtained a written
authorization containing the information required by Sec. 152.86(a) for
the use the any exclusive use study that would be pertinent to the
applicant's product; and
(2) For each person included on the current Data Submitters List as
an original data submitter of data that are not exclusive use for the
active ingredient in question, the applicant has furnished:
(i) A notification of the applicant's intent to apply for
registration, including the name of the proposed product, and a list of
the product's active ingredients;
(ii) Identification of the specific data requirement(s) for which
the offer to pay for data is being made;
(iii) An offer to pay the person compensation to the extent required
by FIFRA section 3(c)(1)(D);
(iv) An offer to commence negotiations to determine the amount and
terms of compensation, if any, to be paid for use of any study; and
(v) The applicant's name, address and telephone number; and
(c) An acknowledgment having the same wording as that specified in
Sec. 152.86(d), except that it may be limited to apply only to data
pertinent to the specific data requirement(s) for which the cite-all
method of support has been selected.
Sec. 152.96 Documentation of a data gap.
Except as provided in paragraph (a) of this section, an applicant
may defer his obligation to satisfy an applicable data requirement until
the Agency requests the data if he can demonstrate, by the procedure in
this section, that no other person has previously submitted to the
Agency a study that would satisfy the data requirement in question.
(a) When data gap procedures may not be used. (1) An applicant for
registration of a product containing a new chemical may not defer his
obligation by the procedure in this section, unless he can demonstrate
to the Agency's satisfaction that the data requirement was imposed so
recently that insufficient time has elapsed for the study to have been
completed and that, in the public interest, the product should be
registered during the limited period of time required to complete the
study. Refer to FIFRA section 3(c)(7)(C).
(2) An applicant for registration of a product under FIFRA section
3(c)(7) (A) or (B) may not defer his obligation by the procedure in this
section if the Agency requires the data to determine:
(i) Whether the product is identical or substantially similar to
another currently registered product or differs only in ways that would
not substantially increase the risk of unreasonable adverse effects on
the environment;
(ii) If efficacy data are required, whether the product is
efficacious; or
(iii) Whether the new use would substantially increase the risk of
unreasonable adverse effects on the environment, usually required when
the application involves a new use of a product which is identical or
substantially similar to a currently registered product.
(b) Data gap listed in a Registration Standard. The applicant may
rely on a data gap that is documented by a Registration Standard without
submitting the certification required by paragraph (c) of this section.
If the data gap listed in the Registration Standard has been filled
since the issuance of the Standard, the Agency will notify the applicant
and require him to choose another method of demonstrating compliance.
(c) Certification of a data gap. Except as provided by paragraph (b)
of this
[[Page 23]]
section, an applicant who wishes to claim that a data gap exists must
certify to the Agency that:
(1) The applicant has furnished, by certified mail, to each original
data submitter on the current Data Submitters List for the active
ingredient in question, a notice containing the following information:
(i) The name and address of the applicant;
(ii) The name of the product, and a statement that the applicant
intends to apply for registration of that product;
(iii) The name(s) of the active ingredient(s) in the procuct;
(iv) A list of the data requirements for which the applicant intends
to claim under this section that a data gap exists; and
(v) A request that the data submitter identify, within 60 days of
receipt of the notice, any valid study which he has submitted to the
Agency that would fulfill any of the data re quirement(s) listed.
(2) The applicant has, within that 60-day period, received no
response, or has received a negative response, from each person
notified; and
(3) The applicant has no basis to believe that any data have been
submitted to the Agency that would fulfill the data requirement, and is
entitled to claim that a data gap exists.
(d) Requirement to obtain permission or make offer to pay. In
responding to a data gap letter, the original data submitter is not
deemed to have given his authorization for the applicant to cite any
study which the data submitter identifies in his response. The applicant
must seek and obtain specific written authorization from, or make an
offer to pay to, the original data submitter to cite the identified
study in order to demonstrate compliance for the data requirement.
Nothing, however, precludes the applicant from requesting written
authorization or making an offer to pay at the same time that he
requests confirmation of a data gap.
Sec. 152.97 Rights and obligations of data submitters.
(a) Right to be listed on Data Submitters List. (1) Each original
data submitter shall have the right to be included on the Agency's Data
Submitters List.
(2) Each original data submitter who wishes to have his name added
to the current Data Submitters List must submit to the Agency the
following information:
(i) Name and current address;
(ii) Chemical name and common name (if any) of the active
ingredient(s), with respect to which he is an original data submitter;
(iii) For each such active ingredient, the type(s) of study he has
previously submitted (corresponding to Guidelines reference numbers
given in tables in 40 CFR part 158, if applicable), the date of
submission, and the EPA registration number, file symbol, or other
identifying reference for which it was submitted.
(3) Each applicant not already included on the Data Submitters List
for a particular active ingredient must inform the Agency at the time of
submission of a relevant study whether he wishes to be included on the
Data Submitters List for that pesticide.
(b) Obligation to respond to data gap letters. An applicant who
chooses to defer his obligation by demonstrating the existence of a data
gap must write to each original data submitter for confirmation that the
data submitter has not submitted a valid study that would satisfy the
requirement. The original data submitter is not required to respond to
such letters. However, if he fails to respond, the applicant is entitled
to assume (and the Agency will act on the assumption) that the original
data submitter has not submitted a study to satisfy the requirement. The
data submitter may thereby limit his right to later challenge the
applicant's claim if he fails respond in writing delivered to the
applicant within 60 days of receipt of the applicant's data gap letter.
Sec. 152.98 Procedures for transfer of exclusive use or compensation
rights to another person.
A person who possesses rights to exclusive use or compensation under
FIFRA section 3(c)(1)(D) may transfer such rights to another person in
accordance with this section.
[[Page 24]]
(a) The original data submitter must submit to the Agency a transfer
document that contains the following information:
(1) The name, address and state of incorporation (if any) of the
original data submitter (the transferor);
(2) The name, address and state of incorporation (if any) of the
person to whom the data rights are being transferred (the transferee);
(3) Identification of each item of data transferred including:
(i) The name of the study or item of data;
(ii) Whether the study is an exclusive use study, and, if so, when
the period of exclusive use protection expires;
(iii) The name of the person or laboratory that conducted the study;
(iv) The date the study was submitted to the Agency;
(v) The EPA document number assigned to the item of data (the Master
Record Identification Number or Accession Number), if known. If not
known, the EPA administrative number (such as the EPA Registration
Number, petition number, file symbol, or permit number) with which the
item of data was submitted, such that the Agency can identify the item
of data.
(vi) A statement that the transferor transfers irrevocably to the
transferee all rights, titles, and interest in the items of data named;
(vii) A statement that the transferor and transferee understand that
any false statement may be punishable under 18 U.S.C. 1001; and
(viii) The names, signatures and titles of the transferor and
transferee, and the date signed.
(b) In addition, the original data submitter must submit to the
Agency a notarized statement affirming that:
(1) The person signing the transfer agreement is authorized by the
original data submitter to bind the data submitter;
(2) No court order prohibits the transfer, and any required court
approvals have been obtained; and
(3) The transfer is authorized under Federal, State, and local law
and relevant corporate charters, bylaws or partnership agreements.
(c) The Agency will acknowledge the transfer of the data by
notifying both transferor and transferee, and will state the effective
date of the transfer. Thereafter the transferee will be considered to be
the original data submitter of the items of data transferred for all
purposes under FIFRA section 3(c)(1)(D), unless a new transfer agreement
is submitted to the Agency.
Sec. 152.99 Petitions to cancel registration.
An original data submitter may petition the Agency to deny or cancel
the registration of a product in accordance with this section if he has
submitted to the Agency a valid study which, he claims, satisfies a data
requirement that an applicant purportedly has failed to satisfy.
(a) Grounds for petition. (1) If an applicant has offered to pay
compensation to an original data submitter of a study (either
specifically or by filing a general offer to pay statement), the
original data submitter may petition the Agency to deny or cancel the
registration to which the offer related on any of the following grounds:
(i) The applicant has failed to participate in an agreed-upon
procedure for reaching an agreement on the amount and terms of
compensation. The petitioner shall submit a copy of the agreed-upon
procedure and describe the applicant's failure to participate in the
procedure.
(ii) The applicant has failed to comply with the terms of an
agreement on compensation. The petitioner shall submit a copy of the
agreement, and shall describe how the applicant has failed to comply
with the agreement.
(iii) The applicant has failed to participate in an arbitration
proceeding. The petitioner shall submit evidence of such failure.
(iv) The applicant has failed to comply with the terms of an
arbitration decision. The petitioner shall submit a copy of the
arbitration decision, and describe how the applicant has failed to
comply with the decision.
(2) When no offer to pay has been made, the petitioner shall state
in his petition the basis for the challenge, and describe how the
failure of the applicant to comply with the procedures of this subpart
has deprived him of the
[[Page 25]]
rights accorded him under FIFRA section 3(c)(1)(D). Possible grounds for
challenge include, but are not limited to, the following:
(i) The applicant has failed to list a data requirement applicable
to his product, or has failed to demonstrate compliance with all
applicable data requirements.
(ii) The applicant has submitted or cited a study that is not valid.
(iii) The applicant has submitted or cited a study that does not
satisfy the data requirement for which it was submitted or cited.
(iv) The applicant has failed to comply with the procedure for
showing that a data gap exists.
(v) The applicant has improperly certified that a data gap exists.
An original data submitter who has failed without good cause to respond
to an applicant's request for confirmation of a data gap may not
petition the Agency for review on this basis.
(vi) The applicant has submitted or cited a study originally
submitted by the petitioner, without the required authorization or offer
to pay.
(b) Procedure for petition to the Agency--(1) Time for filing. A
petition under paragraph (a)(1) of this section may be filed at any time
that the circumstances warrant. A petition under paragraph (a)(2) of
this section must be filed within one year after the Agency makes public
the issuance of the registration.
(2) Notice to affected registrant. At the same time that the
petitioner files his petition with the Agency, he shall send a copy by
certified mail to the affected applicant or registrant. The applicant or
registrant shall have 60 days from the date of his receipt of the
petition to submit written comments to the Agency.
(c) Disposition of petitions. The Agency will consider the material
submitted by the petitioner and the response, if any, by the affected
applicant or registrant.
(1) If the Agency determines that the petition is without merit, it
will inform the petitioner and the affected applicant or registrant that
the petition is denied. Denial of a petition is a final Agency action.
(2) If the Agency determines that an applicant has acted in any way
described by paragraph (a)(1) of this section, the Agency will notify
the petitioner and the affected applicant or registrant that it intends
to deny or cancel the registration of the product in support of which
the data were cited. The affected applicant or registrant will have 15
days from the date of delivery of this notice to respond. If the Agency
determines, after considering any response, that the affected applicant
or registrant has acted in the ways described by paragraph (a)(1) of
this section, the Agency will deny or cancel the registration without
further hearing. Refer to FIFRA section 3(c)(1)(D)(ii). Denial or
cancellation of a registration is a final Agency action.
(3) Except as provided in paragraph (c)(2) of this section, if the
Agency determines that an applicant for registration of a product has
acted in any way that deprives an original data submitter of rights
under FIFRA section 3(c)(1)(D), the Agency will take steps to deny the
application or cancel the registration, as appropriate. The procedures
in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or
cancellation is a final Agency action.
(d) Hearing. Any hearing will be conducted in accordance with the
procedures in 40 CFR part 164. The only matter for resolution at the
hearing shall be whether the registrant failed to comply with the
requirements and procedures of FIFRA section 3(c)(1)(D) or of this
subpart, in the manner described by the petitioner. A decision following
a hearing shall be final.
Subpart F_Agency Review of Applications
Source: 53 FR 15980, May 4, 1988, unless otherwise noted.
Sec. 152.100 Scope.
(a) The Agency will follow the procedures in this subpart for all
applications for registration, except an application for registration of
a pesticide that has been the subject of a previous Agency cancellation
or suspension notice under FIFRA sec. 6.
(b) The Agency will follow the procedures of subpart D of part 164
of this
[[Page 26]]
chapter in evaluating any application for registration of a pesticide
involving use of the pesticide in a manner that is prohibited by a
suspension or cancellation order, to the extent required by subpart D of
part 164.
Sec. 152.102 Publication.
The Agency will issue in the Federal Register a notice of receipt of
each application for registration of a product that contains a new
active ingredient or that proposes a new use. After registration of the
product, the Agency will issue in the Federal Register a notice of
issuance. The notice of issuance will describe the new chemical or new
use, summarize the Agency's regulatory conclusions, list missing data
and the conditions for their submission, and respond to comments
received on the notice of application.
Sec. 152.104 Completeness of applications.
The applicant is responsible for the accuracy and completeness of
all information submitted in connection with the application. The Agency
will review each application to determine whether it is complete. An
application is incomplete if any pertinent item specified in Sec.
152.50 has not been submitted, or has been incorrectly submitted (for
example, data required by part 158 of this chapter not submitted in
accordance with the requirements for format, claims of confidential
business information, or flagging).
Sec. 152.105 Incomplete applications.
The Agency will not begin or continue the review of an application
that is incomplete. If the Agency determines that an application is
incomplete or that further information is needed in order to complete
the Agency's review, the Agency will notify the applicant of the
deficiencies and allow the applicant 75 days to make corrections or
additions to complete the application. If the applicant believes that
the deficiencies cannot be corrected within 75 days, he must notify the
Agency within those 75 days of the date on which he expects to complete
the application. If, after 75 days, the applicant has not responded, or
if the applicant subsequently fails to complete the application within
the time scheduled for completion, the Agency will terminate any action
on such application, and will treat the application as if it had been
withdrawn by the applicant. Any subsequent submission relating to the
same product must be submitted as a new application.
Sec. 152.107 Review of data.
(a) The Agency normally will review data submitted with an
application that have not previously been submitted to the Agency.
(b) The Agency normally will review other data submitted or cited by
an applicant only:
(1) As part of the process of reregistering currently registered
products;
(2) When acting on an application for registration of a product
containing a new active ingredient;
(3) If such data have been flagged in accordance with Sec. 158.34
of this chapter; or
(4) When the Agency determines that it would otherwise serve the
public interest.
(c) If the Agency finds that it needs additional data in order to
determine whether the product may be registered, it will notify the
applicant as early as possible in the review process.
Sec. 152.108 Review of labeling.
The Agency will review all draft labeling submitted with the
application. If an applicant for amended registration submits only that
portion of the labeling proposed for amendment, the Agency may review
the entire label, as revised by the proposed changes, in deciding
whether to approve the amendment. The Agency will not approve final
printed labeling, but will selectively review it for compliance.
Sec. 152.110 Time for Agency review.
The Agency will complete its review of applications as expeditiously
as possible. Applications involving new active ingredients, new uses,
petitions for tolerance or exemptions, or consultation with other
Federal agencies normally will take longer than applications for
substantially similar products and uses.
[[Page 27]]
Sec. 152.111 Choice of standards for review of applications.
The Agency has discretion to review applications under either the
unconditional registration criteria of FIFRA sec. 3(c)(5) or the
conditional registration criteria of FIFRA sec. 3(c)(7). The type of
review chosen depends primarily on the extent to which the relevant data
base has been reviewed for completeness and scientific validity. EPA
conducts data reviews needed to support unconditional registrations on a
chemical-by-chemical basis, according to an established priority list.
Except for applications for registration of a new active ingredient or
in special cases where it finds immediate review to be warranted, the
Agency will not commence a complete review of the existing data base on
a given chemical in response to receipt of an application for
registration. Instead the Agency will review the application using the
criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).
Sec. 152.112 Approval of registration under FIFRA sec. 3(c)(5).
EPA will approve an application under the criteria of FIFRA sec.
3(c)(5) only if:
(a) The Agency has determined that the application is complete and
is accompanied by all materials required by the Act and this part,
including, but not limited to, evidence of compliance with subpart E of
this part;
(b) The Agency has reviewed all relevant data in the possession of
the Agency (see Sec. Sec. 152.107 and 152.111);
(c) The Agency has determined that no additional data are necessary
to make the determinations required by FIFRA sec. 3(c)(5) with respect
to the pesticide product which is the subject of the application;
(d) The Agency has determined that the composition of the product is
such as to warrant the proposed efficacy claims for it, if efficacy data
are required to be submitted by part 158 of this chapter for the
product;
(e) The Agency has determined that the product will perform its
intended function without unreasonable adverse effects on the
environment, and that, when used in accordance with widespread and
commonly recognized practice, the product will not generally cause
unreasonable adverse effects on the environment;
(f) The Agency has determined that the product is not misbranded as
that term is defined in FIFRA sec. 2(q) and part 156 of this chapter,
and its labeling and packaging comply with the applicable requirements
of the Act, this part, and parts 156 and 157 of this chapter;
(g) If the proposed labeling bears directions for use on food,
animal feed, or food or feed crops, or if the intended use of the
pesticide results or may reasonably be expected to result, directly or
indirectly, in pesticide residues (including residues of any active or
inert ingredient of the product, or of any metabolite or degradation
product thereof) in or on food or animal feed, all necessary tolerances,
exemptions from the requirement of a tolerance, and food additive
regulations have been issued under FFDCA sec. 408, sec. 409 or both; and
(h) If the product, in addition to being a pesticide, is a drug
within the meaning of FFDCA sec. 201(q), the Agency has been notified by
the Food and Drug Administration (FDA) that the product complies with
any requirements imposed by FDA.
Sec. 152.113 Approval of registration under FIFRA sec. 3(c)(7)--Products
that do not contain a new active ingredient.
(a) Except as provided in paragraph (b) of this section, the Agency
may approve an application for registration or amended registration of a
pesticide product, each of whose active ingredients is contained in one
or more other registered peticide products, only if the Agency has
determined that:
(1) It possesses all data necessary to make the determinations
required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide
product which is the subject of the application (including, at a
minimum, data needed to characterize any incremental risk that would
result from approval of the application);
(2) Approval of the application would not significantly increase the
risk of any unreasonable adverse effect on the environment; and
[[Page 28]]
(3) The criteria of Sec. 152.112(a), (d), and (f) through (h) have
been satisfied.
(b) Notwithstanding the provisions of paragraph (a) of this section,
the Agency will not approve the conditional registration of any
pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined
that the applicant's product and its proposed use are identical or
substantially similar to a currently registered pesticide and use, or
that the pesticide and its proposed use differ only in ways that would
not significantly increase the risk of unreasonable adverse effects on
the environment.
(c) Notwithstanding the provisions of paragraph (a) of this section,
the Agency will not approve the conditional registration of any
pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
(1) The pesticide is the subject of a special review, based on a use
of the product that results in human dietary exposure; and
(2) The proposed new use involves use on a major food or feed crop,
or involves use on a minor food or feed crop for which there is
available an effective alternative registered pesticide which does not
meet the risk criteria associated with human dietary exposure. The
determination of available and effective alternatives shall be made with
the concurrence of the Secretary of Agriculture.
Sec. 152.114 Approval of registration under FIFRA sec. 3(c)(7)--Products
that contain a new active ingredient.
An application for registration of a pesticide containing an active
ingredient not in any currently registered product may be conditionally
approved for a period of time sufficient for the generation and
submission of certain of the data necessary for a finding of
registrability under FIFRA sec. 3(c)(5) if the Agency determines that:
(a) Insufficient time has elapsed since the imposition of the data
requirement for those data to have been developed;
(b) All other required test data and materials have been submitted
to the Agency;
(c) The criteria in Sec. 152.112(a), (b), (d), and (f) through (h)
have been satisfied;
(d) The use of the pesticide product during the period of the
conditional registration will not cause any unreasonable adverse effect
on the environment; and
(e) The registration of the pesticide product and its subsequent use
during the period of the conditional registration are in the public
interest.
Sec. 152.115 Conditions of registration.
(a) Substantially similar products and new uses. Each registration
issued under Sec. 152.113 shall be conditioned upon the submission or
citation by the registrant of all data which are required for
unconditional registration of his product under FIFRA sec. 3(c)(5), but
which have not yet been submitted, no later than the time such data are
required to be submitted for similar pesticide products already
registered. If a notice requiring submission of such data has been
issued under FIFRA sec. 3(c)(2)(B) prior to the date of approval of the
application, the applicant must submit or cite the data described by
that notice at the time specified by that notice. The applicant must
agree to these conditions before the application may be approved.
(b) New active ingredients. Each registration issued under Sec.
152.114 shall be conditioned upon the applicant's agreement to each of
the following conditions:
(1) The applicant will submit remaining required data (and interim
reports if required) in accordance with a schedule approved by the
Agency.
(2) The registration will expire upon a date established by the
Agency, if the registrant fails to submit data as required by the
Agency. The expiration date will be established based upon the length of
time necessary to generate and submit the required data. If the studies
are submitted in a timely manner, the registration will be cancelled if
the Agency determines, based on the data (alone, or in conjuction with
other data), that the product or one or more of its uses meets or
exceeds any of the risk criteria established by the Agency to initiate a
special review. If the Agency so determines, it will issue to the
registrant a Notice of Intent to Cancel under FIFRA sec. 6(e), and will
[[Page 29]]
specify any provisions for sale and distribution of existing stocks of
the pesticide product.
(3) The applicant will submit an annual report of the production of
the product.
(c) Other conditions. The Agency may establish, on a case-by-case
basis, other conditions applicable to registrations to be issued under
FIFRA sec. 3(c)(7).
(d) Cancellation if condition is not satisfied. If any condition of
the registration of the product is not satisfied, or if the Agency
determines that the registrant has failed to initiate or pursue
appropriate action towards fulfillment of any condition, the Agency will
issue a notice of intent to cancel under FIFRA sec. 6(e).
[53 FR 15980, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
Sec. 152.116 Notice of intent to register to original submitters of
exclusive use data.
(a) Except as provided in paragraph (c) of this section, at least 30
days before registration of a product containing an active ingredient
for which a previously submitted study is eligible for exclusive use
under FIFRA sec. 3(c)(1)(D)(i), the Agency will notify the original
submitter of the exclusive use study of the intended registration of the
product. If requested by the exclusive use data submitter within 30
days, the Agency will also provide the applicant's list of data
requirements and method of demonstrating compliance with each data
requirement.
(b) Within 30 days after receipt of the Agency's notice, or of the
applicant's list of data requirements, whichever is later, the exclusive
use data submitter may challenge the issuance of the registration in
accordance with the procedures in Sec. 152.99 (b) and (c). If the
Agency finds that the challenge has merit, it will issue a notice of
denial of the application. The applicant may then avail himself of the
hearing procedures provided by FIFRA sec. 3(c)(6). If the Agency finds
that the challenge is without merit, it will deny the petition and
register the applicant's product. Denial of the petition is a final
Agency action.
(c) If an applicant has submitted to the Agency a certification from
an exclusive use data submitter that he is aware of the applicant's
application for registration, and does not object to the issuance of the
registration, the Agency will not provide the 30-day notification
described in paragraph (a) of this section to that exclusive use data
submitter.
Sec. 152.117 Notification to applicant.
The Agency will notify the applicant of the approval of his
application by a Notice of Registration for new registration, or by a
letter in the case of an amended registration.
Sec. 152.118 Denial of application.
(a) Basis for denial. The Agency may deny an application for
registration if the Agency determines that the pesticide product does
not meet the criteria for registration under either FIFRA sec. 3(c)(5)
or (7), as specified in Sec. Sec. 152.112 through 152.114.
(b) Notification of applicant. If the Agency determines that an
application should be denied, it will notify the applicant by certified
letter. The letter will set forth the reasons and factual basis for the
determination with conditions, if any, which must be fulfilled in order
for the registration to be approved.
(c) Opportunity for remedy by the applicant. The applicant will have
30 days from the date of receipt of the certified letter to take the
specified corrective action. During this time the applicant may request
that his application be withdrawn.
(d) Notice of denial. If the applicant fails to correct the
deficiencies within the 30-day period, the Agency may issue a notice of
denial, which will be published in the Federal Register, and which will
set forth the reasons and the factual basis for the denial.
(e) Hearing rights. Within 30 days following the publication of the
notice of denial, an applicant, or any interested person with written
authorization of the applicant, may request a hearing in accordance with
FIFRA sec. 6(b). Hearings will be conducted in accordance with part 164
of this chapter.
[[Page 30]]
Sec. 152.119 Availability of material in support of registration.
(a) The information submitted to support a registration application
shall be part of the official Agency file for that registration.
(b) Within 30 days after registration, the Agency will make
available for public inspection, upon request, the materials required by
subpart E to be submitted with an application. Materials that will be
publicly available include an applicant's list of data requirements, the
method used by the applicant to demonstrate compliance for each data
requirement, and the applicant's citations of specific studies in the
Agency's possession if applicable.
(c) Except as provided by FIFRA sec. 10, within 30 days after
registration, the data on which the Agency based its decision to
register the product will be made available for public inspection, upon
request, in accordance with the procedures in 40 CFR part 2.
Subpart G_Obligations and Rights of Registrants
Source: 53 FR 15983, May 4, 1988, unless otherwise noted.
Sec. 152.122 Currency of address of record and authorized agent.
(a) The registrant must keep the Agency informed of his current name
and address of record. If the Agency's good faith attempts to contact
the registrant are not successful, the Agency will issue in the Federal
Register a notice of intent to cancel all products of the registrant
under FIFRA sec. 6(b). The registrant must respond within 30 days
requesting that the registrations be maintained in effect, and providing
his name and address of record. If no response is received, the
cancellations will become effective at the end of 30 days without
further notice to the registrant. The Agency may make provision for the
sale and distribution of existing stocks of such products after the
effective date of cancellation.
(b) The registrant must also notify the Agency if he changes his
authorized agent.
Sec. 152.125 Submission of information pertaining to adverse effects.
If at any time the registrant receives or becomes aware of any
factual information regarding unreasonable adverse effects of the
pesticide on the environment that has not previously been submitted to
the Agency, he shall, in accordance with FIFRA sec. 6(a)(2), provide
such information to the Agency, clearly identified as FIFRA 6(a)(2)
data.
[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
Sec. 152.130 Distribution under approved labeling.
(a) A registrant may distribute or sell a registered product with
the composition, packaging and labeling currently approved by the
Agency.
(b) A registrant may distribute or sell a product under labeling
bearing any subset of the approved directions for use, provided that in
limiting the uses listed on the label, no changes would be necessary in
precautionary statements, use classification, or packaging of the
product.
(c) Normally, if the product labeling is amended on the initiative
of the registrant, by submission of an application for amended
registration, the registrant may distribute or sell under the previously
approved labeling for a period of 18 months after approval of the
revision, unless an order subsequently issued by the Agency under FIFRA
sec. 6 or 13 provides otherwise. However, if paragraph (d) of this
section applies to the registrant's product, the time frames established
by the Agency in accordance with that paragraph shall take precedence.
(d) If a product's labeling is required to be revised as a result of
the issuance of a Registration Standard, a Label Improvement Program
notice, or a notice concluding a special review process, the Agency will
specify in the notice to the registrant the period of time that
previously approved labeling may be used. In all cases, supplemental or
sticker labeling may be used as an interim compliance measure for a
reasonable period of time. The Agency may establish dates as follows
governing when label changes must appear on labels:
[[Page 31]]
(1) The Agency may establish a date after which all product
distributed or sold by the registrant must bear revised labeling.
(2) The Agency may also establish a date after which no product may
be distributed or sold by any person unless it bears revised labeling.
This date will provide sufficient time for product in channels of trade
to be distributed or sold to users or otherwise disposed of.
Sec. 152.132 Supplemental distribution.
The registrant may distribute or sell his registered product under
another person's name and address instead of (or in addition to) his
own. Such distribution and sale is termed ``supplemental distribution''
and the product is referred to as a ``distributor product.'' The
distributor is considered an agent of the registrant for all intents and
purposes under the Act, and both the registrant and the distributor may
be held liable for violations pertaining to the distributor product.
Supplemental distribution is permitted upon notification to the Agency
if all the following conditions are met:
(a) The registrant has submitted to the Agency for each distributor
product a statement signed by both the registrant and the distributor
listing the names and addresses of the registrant and the distributor,
the distributor's company number, the additional brand name(s) to be
used, and the registration number of the registered product.
(b) The distributor product is produced, packaged and labeled in a
registered establishment operated by the same producer (or under
contract in accordance with Sec. 152.30) who produces, packages, and
labels the registered product.
(c) The distributor product is not repackaged (remains in the
producer's unopened container).
(d) The label of the distributor product is the same as that of the
registered product, except that:
(1) The product name of the distributor product may be different
(but may not be misleading);
(2) The name and address of the distributor may appear instead of
that of the registrant;
(3) The registration number of the registered product must be
followed by a dash, followed by the distributor's company number
(obtainable from the Agency upon request);
(4) The establishment number must be that of the final establishment
at which the product was produced; and
(5) Specific claims may be deleted, provided that no other changes
are necessary.
(e) Voluntary cancellation of a product applies to the registered
product and all distributor products distributed or sold under that
registration number. The registrant is responsible for ensuring that
distributors under his cancelled registration are notified and comply
with the terms of the cancellation.
[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
Sec. 152.135 Transfer of registration.
(a) A registrant may transfer the registration of a product to
another person, and the registered product may be distributed and sold
without the requirement of a new application for registration by that
other person, if the parties submit to the Agency the documents listed
in paragraphs (b) and (c) of this section, and receive Agency approval
as described in paragraph (d) of this section.
(b) Persons seeking approval of a transfer of registration must
provide a document signed by the authorized representative of the
registrant (the transferor) and of the person to whom the registration
is transferred (the transferee) that contains the following information:
(1) The name, address and State of incorporation (if any) of the
transferor;
(2) The name, address and State of incorporation of the transferee;
(3) The name(s) and EPA registration number(s) of the product(s)
being transferred;
(4) A statement that the transferor transfers irrevocably to the
transferee all right, title, and interest in the EPA registration(s)
listed in the document;
(5) A statement that the transferred registration(s) shall not serve
as collateral or otherwise secure any loan or
[[Page 32]]
other payment arrangement or executory promise, and that the reg is tra
tion(s) shall not revert to the transferor unless a new transfer
agreement is submitted to and approved by the Agency;
(6) A description of the general nature of the underlying
transaction, e.g., merger, spinoff, bankruptcy transfer (no financial
information need be disclosed);
(7) A statement that the transferor and transferee understand that
any false statement may be punishable under 18 U.S.C. 1001; and
(8) An acknowledgment by the transferee that his rights and duties
concerning the registration under FIFRA and this chapter will be deemed
by EPA to be the same as those of the transferor at the time the
transfer is approved.
(c) In addition, the transferor must submit to the Agency a
notarized statement affirming that:
(1) The person signing the transfer agreement is authorized by the
registrant to bind the transferor;
(2) No court order prohibits the transfer, and that any required
court approvals have been obtained; and
(3) The transfer is authorized under all relevant Federal, State and
local laws and all relevant corporate charters, bylaws, partnerships, or
other agreements.
(d) If the required documents are submitted, and no information
available to the Agency indicates that the information is incorrect, the
Agency will approve the transfer without requiring that the transferee
obtain a new registration. The Agency will notify the transferor and
transferee of its approval.
(e) The transfer will be effective on the date of Agency approval.
Thereafter the transferee will be regarded as the registrant for all
purposes under FIFRA.
(f) Rights to exclusive use of data or compensation under FIFRA sec.
3(c)(1)(D) are separate from the registration itself and may be retained
by the transferor, or may be transferred independently in accordance
with the provisions of Sec. 152.98. If the registrant as the original
data submitter wishes to transfer data rights at the same time as he
transfers the registration, he may submit a single transfer document
containing the information required by this section for both the
registration and the data.
[53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]
Subpart H [Reserved]
Subpart I_Classification of Pesticides
Source: 53 FR 15986, May 4, 1988, unless otherwise noted.
Sec. 152.160 Scope.
(a) Types of classification. A pesticide product may be
unclassified, or it may be classified for restricted use or for general
use. The Agency does not normally classify products for general use;
products that are not restricted remain unclassified.
(b) Kinds of restrictions. The Agency may restrict a product or its
uses to use by a certified applicator, or by or under the direct
supervision of a certified applicator, as described in FIFRA sec.
3(d)(1)(C). The Agency may also, by regulation, prescribe restrictions
relating to the product's composition, labeling, packaging, uses, or
distribution and sale, or to the status or qualifications of the user.
Sec. 152.161 Definitions.
In addition to the definitions in Sec. 152.3, the following terms
are defined for the purposes of this subpart:
(a) Dietary LC50 means a statistically derived estimate
of the concentration of a test substance in the diet that would cause 50
percent mortality to the test population under specified conditions.
(b) Outdoor use means any pesticide application that occurs outside
enclosed manmade structures or the consequences of which extend beyond
enclosed manmade structures, including, but not limited to, pulp and
paper mill water treatments and industrial cooling water treatments.
Sec. 152.164 Classification procedures.
(a) Grouping of products for classification purposes. In its
discretion, the
[[Page 33]]
Agency may identify a group of products having common characteristics or
uses and may classify for restricted use same or all of the products or
uses included in that group. Such a group may be comprised of, but is
not limited to, products that:
(1) Contain the same active ingredients.
(2) Contain the same active ingredients in a particular
concentration range, formulation type, or combination of concentration
range and formulation type.
(3) Have uses in common.
(4) Have other characteristics, such as toxicity, flammability, or
physical properties, in common.
(b) Classification reviews. The Agency may conduct classification
reviews and classify products at any time, if it determines that a
restriction on the use of a pesticide product is necessary to avoid
unreasonable adverse effects on the environment. However, classification
reviews normally will be conducted and products classified only in the
following circumstances:
(1) As part of the review of an application for new registration of
a product containing an active ingredient not contained in any currently
registered product.
(2) As part of the review of an application for a new use of a
product, if existing uses of that product previously have been
classified for restricted use. Review of a restricted use product at
this time is for the purpose of determining whether the new use should
also be classified for restricted use. Normally the Agency will not
conduct initial classification reviews for existing uses of individual
products in conjunction with an application for amended registration.
(3) As part of the process of developing or amending a registration
standard for a pesticide. The Agency normally will conduct
classification reviews of all uses of a currently registered pesticide
at this time.
(4) As part of any special review of a pesticide, in accordance with
the procedures of 40 CFR part 154.
(c) Classification procedures. (1) If the Agency determines that a
product or one or more of its uses should be classified for restricted
use, the Agency initially may classify the product by regulation. In
this case, within 60 days after the effective date of a final rule, each
registrant of a product subject to the rule must submit to the Agency
one of the following, as directed in the final rule:
(i) A copy of the amended label and any supplemental labeling to be
used as an interim compliance measure.
(ii) A statement, which the Agency considers a report under the Act,
that the registrant will comply with the labeling requirements
prescribed by the Agency within the timeframes prescribed by the
regulation.
(iii) An application for amended registration to delete the uses
which have been restricted, or to ``split'' the registration into two
registrations, one including only restricted or all uses, and the other
including only uses that have not been classified.
(2) Alternatively, EPA may notify the applicant or registrant of the
classification decision and require that he submit the information
required by paragraph (c)(1) of this section. The Agency may deny
registration or initiate cancellation proceedings if the registrant
fails to comply within the timeframes established by the Agency in its
notification.
Sec. 152.166 Labeling of restricted use products.
(a) Products intended for end use. A product whose labeling bears
directions for end use and that has been classified for restricted use
must be labeled in accordance with the requirements of Sec. 156.10 of
this chapter or other Agency instructions. The Agency will permit the
use of stickers or supplemental labeling as an interim alternative to
the use of an approved amended label, in accordance with Sec. 152.167.
(b) Products intended only for formulation. A product whose labeling
does not bear directions for end use (a product that is intended and
labeled solely for further formulation into other pesticide products) is
not subject to the labeling requirements of this subpart.
[[Page 34]]
Sec. 152.167 Distribution and sale of restricted use products.
Unless modified by the Agency, the compliance dates in this section
shall apply to restricted use products.
(a) Sale by registrant or producer. (1) No product with a use
classified for restricted use may be distributed or sold by the
registrant or producer after the 120th day after the effective date of
such classification unless the product:
(i) Bears an approved amended label which contains the terms of
restricted use imposed by the Agency and otherwise complies with part
156 of this chapter;
(ii) Bears a sticker containing the product name, EPA registration
number, and any terms of restricted use imposed by the Agency; or
(iii) Is accompanied by supplemental labeling bearing the
information listed in paragraph (a)(1)(ii) of this section.
(2) If the registrant chooses to delete the restricted uses from his
product label, that product may not be distributed or sold after the
180th day after the effective date of classification unless the product
bears amended labeling with the restricted uses deleted.
(3) Notwithstanding paragraphs (a) (1) and (2) of this section,
after the 270th day after the effective date of classification, no
registrant or producer may distribute or sell a product that does not
bear the approved amended label. After that date, stickers and
supplemental labeling described in paragraph (a)(1) (ii) and (iii) are
no longer acceptable.
(b) Sale by retailer. No product with a use classified for
restricted use by a regulation may be distributed or sold by a retailer
or other person after the 270th day after the effective date of the
final rule unless the product bears a label or labeling which complies
with paragraph (a)(1) of this section.
Sec. 152.168 Advertising of restricted use products.
(a) Any product classified for restricted use shall not be
advertised unless the advertisement contains a statement of its
restricted use classification.
(b) The requirement in paragraph (a) of this section applies to all
advertisements of the product, including, but not limited, to:
(1) Brochures, pamphlets, circulars and similar material offered to
purchasers at the point of sale or by direct mail.
(2) Newspapers, magazines, newsletters and other material in
circulation or available to the public.
(3) Broadcast media such as radio and television.
(4) Telephone advertising.
(5) Billboards and posters.
(c) The requirement may be satisfied for printed material by
inclusion of the statement ``Restricted Use Pesticide,'' or the terms of
restriction, prominently in the advertisement. The requirement may be
satisfied with respect to broadcast or telephone advertising by
inclusion in the broadcast of the spoken words ``Restricted use
pesticide,'' or a statement of the terms of restriction.
(d) The requirements of this section shall be effective:
(1) After 270 days after the effective date of restriction of a
product that is currently registered, unless the Agency specifies a
shorter time period;
(2) Upon the effective date of registration of a product not
currently registered.
Sec. 152.170 Criteria for restriction to use by certified applicators.
(a) General criteria. An end-use product will be restricted to use
by certified applicators (or persons under their direct supervision) if
the Agency determines that:
(1) Its toxicity exceeds one or more of the specific hazard criteria
in paragraph (b) or (c) of this section, or evidence described in
paragraph (d) of this section substantiates that the product or use
poses a serious hazard that may be mitigated by restricting its use;
(2) Its labeling, when considered according to the factors in
paragraph (e)(2) of this section, is not adequate to mitigate these
hazard(s);
(3) Restriction of the product would decrease the risk of adverse
effects; and
(4) The decrease in risks of the pesticide as a result of
restriction would exceed the decrease in benefits.
[[Page 35]]
(b) Criteria for human hazard--(1) Residential and institutional
uses. A pesticide product intended for residential or institutional use
will be considered for restricted use classification if:
(i) The pesticide, as diluted for use, has an acute oral
LD50 of 1.5 g/kg or less;
(ii) The pesticide, as formulated, has an acute dermal
LD50 of 2000 mg/kg or less;
(iii) The pesticide, as formulated, has an acute inhalation
LC50 of 0.5 mg/liter or less, based upon a 4-hour exposure
period;
(iv) The pesticide, as formulated, is corrosive to the eye (causes
irreversible destruction of ocular tissue) or results in corneal
involvement or irritation persisting for more than 7 days;
(v) The pesticide, as formulated, is corrosive to the skin (causes
tissue destruction into the dermis and/or scarring) or causes severe
irritation (severe erythema or edema) at 72 hours; or
(vi) When used in accordance with label directions, or widespread
and commonly recognized practice, the pesticide may cause significant
subchronic, chronic or delayed toxic effects on man as a result of
single or multiple exposures to the product ingredients or residues.
(2) All other uses. A pesticide product intended for uses other than
residential or institutional use will be considered for restricted use
classification if:
(i) The pesticide, as formulated, has an acute oral LD50
of 50 mg/kg or less;
(ii) The pesticide, as formulated, has an acute dermal
LD50 of 200 mg/kg or less;
(iii) The pesticide, as diluted for use, has an acute dermal
LD50 of 16 g/kg or less;
(iv) The pesticide, as formulated, has an acute inhalation
LC50 of 0.05 mg/liter or less, based upon a 4-hour exposure
period;
(v) The pesticide, as formulated, is corrosive to the eye or causes
corneal involvement or irritation persisting for more than 21 days;
(vi) The pesticide, as formulated, is corrosive to the skin (causes
tissue destruction into the dermis and/or scarring); or
(vii) When used in accordance with label directions, or widespread
and commonly recognized practice, the pesticide may cause significant
sub chron ic toxicity, chronic toxicity, or delayed toxic effects on
man, as a result of single or multiple exposures to the product
ingredients or residues.
(c) Criteria for hazard to non-target species--(1) All products. A
pesticide product intended for outdoor use will be considered for
restricted use classification if:
(i) When used according to label directions, application results in
residues of the pesticide, its metabolites, or its degradation products,
in the diet of exposed mammalian wildlife, immediately after
application, such that:
(A) The level of such residues equals or exceeds one-fifth of the
acute dietary LC50; or
(B) The amount of pesticide consumed in one feeding day (mg/kg/day)
equals or exceeds one-fifth of the mammalian acute oral LD50;
(ii) When used according to label directions, application results,
immediately after application, in residues of the pesticide, its
metabolites or its degradation products, in the diet of exposed birds at
levels that equal or exceed one-fifth of the avian subacute dietary
LC50;
(iii) When used according to label directions, application results
in residues of the pesticide, its metabolites or its degradation
products, in water that equal or exceed one-tenth of the acute
LC50 for non-target aquatic organisms likely to be exposed;
or
(iv) Under conditions of label use or widespread and commonly
recognized practice, the pesticide may cause discernible adverse effects
on non-target organisms, such as significant mortality or effects on the
physiology, growth, population levels or reproduction rates of such
organisms, resulting from direct or indirect exposure to the pesticide,
its metabolites or its degradation products.
(2) Granular products. In addition to the criteria of paragraph
(c)(1) of this section, a pesticide intended for outdoor use and
formulated as a granular product will be considered for restricted use
classification if:
(i) The formulated product has an acute avian or mammalian oral
LD50 of
[[Page 36]]
50 mg/kg or less as determined by extrapolation from tests conducted
with technical material or directly with the formulated product; and
(ii) It is intended to be applied in such a manner that significant
exposure to birds or mammals may occur.
(d) Other evidence. The Agency may also consider evidence such as
field studies, use history, accident data, monitoring data, or other
pertinent evidence in deciding whether the product or use may pose a
serious hazard to man or the environment that can reasonably be
mitigated by restricted use classification.
(e) Alternative labeling language. (1) If the Agency determines that
a product meets one or more of the criteria of paragraphs (b) or (c) of
this section, or if other evidence identified in paragraph (d) of this
section leads the Agency to conclude that the product should be
considered for restricted use classification, the Agency will then
determine if additional labeling language would be adequate to mitigate
the identified hazard(s) without restricted use classification. If the
labeling language meets all the criteria specified in paragraph (e)(2)
of this section, the product will not be classified for restricted use.
(2) The labeling will be judged adequate if it meets all the
following criteria:
(i) The user, in order to follow label directions, would not be
required to perform complex operations or procedures requiring
specialized training and/or experience.
(ii) The label directions do not call for specialized apparatus,
protective equipment, or materials that reasonably would not be
available to the general public.
(iii) Failure to follow label directions in a minor way would result
in few or no significant adverse effects.
(iv) Following directions for use would result in few or no
significant adverse effects of a delayed or indirect nature through
bioaccumulation, persistence, or pesticide movement from the original
application site.
(v) Widespread and commonly recognized practices of use would not
nullify or detract from label directions such that unreasonable adverse
effects on the environment might occur.
Sec. 152.171 Restrictions other than those relating to use by certified
applicators.
The Agency may by regulation impose restrictions on a product or
class of products if it determines that:
(a) Without such restrictions, the product when used in accordance
with warnings, cautions and directions for use or in accordance with
widespread and commonly recognized practices of use may cause
unreasonable adverse effects on the environment; and
(b) The decrease in risks as a result of restricted use would exceed
the decrease in benefits as a result of restricted use.
Sec. 152.175 Pesticides classified for restricted use.
The following uses of pesticide products containing the active
ingredients specified below have been classified for restricted use and
are limited to use by or under the direct supervision of a certified
applicator.
[[Page 37]]
----------------------------------------------------------------------------------------------------------------
Criteria
Active ingredient Formulation Use pattern Classification influencing
\1\ restriction
----------------------------------------------------------------------------------------------------------------
Acrolein....................... As sole active All uses.......... Restricted....... Inhalation hazard
ingredient. No to humans.
mixtures registered. Residue effects
on avian species
and aquatic
organisms.
Aldicarb....................... As sole active Ornamental uses ......do......... Other hazards--
ingredient. (indoor and accident
outdoor). history.
No mixtures Agricultural crop Under further
registered. uses. evaluation.
Aluminum phosphide............. As sole active ......do.......... ......do......... Inhalation hazard
ingredient. No to humans.
mixtures registered.
Azinphos methyl................ All liquids with a ......do.......... ......do......... Do.
concentration
greater than 13.5
pct.
All other ......do.......... Under futher
formulations. evaluation..
Carbofuran..................... All concentrate ......do.......... ......do......... Acute inhalation
suspensions and toxicity.
wettable powders 40%
and greater.
All granular Rice.............. Under evaluation.
formulations.
All granular and All uses except ......do.........
fertilizer rice.
formulations.
Chloropicrin................... All formulations All uses.......... ......do......... Acute inhalation
greater than 2%. toxicity.
All formulations..... Rodent control.... ......do......... Hazard to non-
target
organisms.
All formulations 2% Outdoor uses Unclassified.....
and less. (other than
rodent control).
Clonitralid.................... All wettable powders All uses.......... Restricted....... Acute inhalation
70% and greater. toxicity.
All granulars and Molluscide uses... Restricted....... Effects on
wettable powders. aquatic
organisms.
Pressurized sprays Hospital Unclassified.....
0.55% and less. antiseptics.
Dicrotophos.................... All liquid All uses.......... Restricted....... Acute dermal
formulations 8% and toxicity;
greater. residue effects
on avian species
(except for tree
injections).
Disulfoton..................... All emulsifiable ......do.......... Restricted....... Do.
concentrates 65% and Acute inhalation
greater, all toxicity.
emulsifiable
concentrates and
concentrate
solutions 21% and
greater with
fensulfothion 43%
and greater, all
emulsifiable
concentrates 32% and
greater in
combination with 32%
fensulfothion and
greater.
Non-aqueous solution Commercial seed Restricted....... Acute dermal
95% and greater. treatment. toxicity.
Granular formulations Indoor uses ......do......... Acute inhalation
10% and greater. (greenhouse). toxicity.
Ethoprop....................... Emulsifiable Aquatic uses...... ......do......... Acute dermal
concentrates 40% and toxicity.
greater.
All granular and All uses.......... Under evaluation.
fertilizer
formulations.
Ethyl parathion................ All granular and dust ......do.......... Restricted....... Inhalation hazard
formulations greater to humans. Acute
than 2 pct, dermal toxicity.
fertilizer Residue effects
formulations, on mammalian,
wettable powders, aquatic, avian
emulsifiable species.
concentrates,
concentrated
suspensions,
concentrated
solutions.
Smoke fumigants...... ......do.......... ......do......... Inhalation hazard
to humans.
Dust and granular ......do.......... ......do......... Other hazards--
formulations 2 pct accident
and below. history.
Fenamiphos..................... Emulsifiable ......do.......... ......do......... Acute dermal
concentrates 35% and toxicity.
greater.
Fonofos........................ Emulsifiable ......do.......... ......do......... Acute dermal
concentrates 44% and toxicity.
greater.
Emulsifiable Tobacco........... Unclassified.....
concentrates 12.6%
and less with
pebulate 50.3% and
less.
Methamidophos.................. Liquid formulations ......do.......... Restricted....... Acute dermal
40% and greater. toxicity;
residue effects
on avian
species.
[[Page 38]]
Dust formulations ......do.......... ......do......... Residue effects
2.5% and greater. on avian
species.
Methidathion................... All formulations..... All uses except ......do......... Do.
nursery stock,
safflower and
sunflower.
All formulations..... Nursery stock, Unclassified.....
safflower and
sunflower.
Methomyl....................... As sole active Nondomestic Restricted....... Residue effects
ingredient in 1 pct outdoors- on mammalian
to 2.5 baits (except agricultural species.
1 pct fly bait). crops, ornamental
and turf. All
other registered
uses.
All concentrated ......do.......... ......do......... Other hazards-
solution accident
formulations. history.
90 pct wettable ......do.......... ......do......... Do.
powder formulations
(not in water
soluble bags).
90 pct wettable ......do.......... Unclassified.....
powder formulation
in water soluble
bags.
All granular ......do.......... ......do.........
formulations.
25 pct wettable ......do.......... ......do.........
powder formulations.
In 1.24 pct to 2.5 ......do.......... ......do.........
pct dusts as sole
active ingredient
and in mixtures with
fungicides and
chlorinated
hydrocarbon,
inorganic phosphate
and biological
insecticides.
Methyl bromide................. All formulations in All uses.......... Restricted....... Do.
containers greater
than 1.5 lb.
Containers with not Single Unclassified.....
more than 1.5 lb of applications
methyl bromide with (nondomestic use)
0.25 pct to 2.0 pct for soil
chloropicrin as an treatment in
indicator. closed systems.
Container with not All uses.......... Restricted....... Do.
more than 1.5 lb
having no indicator.
Methyl parathion............... All dust and granular ......do.......... ......do......... Other hazards-
formulations less accident
than 5 pct. history. All
foliar
applications
restricted based
on residue
effects on
mammalian and
avian species.
Microencapsulated.... ......do.......... ......do......... Residue effects
on avian
species. Hazard
to bees.
All dust and granular ......do.......... ......do......... Acute dermal
formulations 5 pct toxicity.
and greater and all Residue effects
wettable powders and on mammalian and
liquids. avian species.
Nicotine (alkaloid)............ Liquid and dry Indoor ......do......... Acute inhalation
formulations 14% and (greenhouse). toxicity.
above.
All formulations..... Applications to ......do......... Effects on
cranberries. aquatic
organisms.
Liquid and dry All uses (domestic Unclassified.....
formulations 1.5% and nondomestic).
and less.
Paraquat (dichloride) and All formulations and All uses.......... Restricted....... Other hazards.
paraquat bis(methyl sulfate). concentrations Use and accident
except those listed history, human
below. toxicological
data.
Pressurized spray Spot weed and ......do.........
formulations grass control.
containing 0.44 pct
Paraquat bis(methyl
sulfate) and 15 pct
petroleum
distillates as
active ingredients.
Liquid fertilizers All uses.......... Unclassified.....
containing
concentrations of
0.025 pct paraquat
dichloride and 0.03
percent atrazine;
0.03 pct paraquat
dichloride and 0.37
pct atrazine, 0.04
pct paraquat
dichloride and 0.49
pct atrazine.
[[Page 39]]
Phorate........................ Liquid formulations ......do.......... Restricted....... Acute dermal
65% and greater. toxicity.
Residue effects
on avian species
(applies to
foliar
applications
only).
Residue effects
on mammalian
species (applies
to foliar
application
only).
All granular Rice.............. ......do......... Effects on
formulations. aquatic
organisms.
Phosphamidon................... Liquid formulations ......do.......... ......do......... Acute dermal
75% and greater. toxicity.
Residue effects
on mammalian
species.
Residue effects
on avian
species.
Dust formulations ......do.......... ......do......... Do.
1.5% and greater. Residue effects
on mammalian
species.
Picloram....................... All formulations and ......do.......... ......do......... Hazard to
concentrations nontarget
except tordon 101 R. organisms
(specifically
nontarget plants
both crop and
noncrop).
Tordon 101 R forestry Control of Unclassified.....
herbicide containing unwanted trees by
5.4 pct picloram and cut surface
20.9 pct 2.4-D. treatment.
Sodium cyanide \3\............. All capsules and ball All uses.......... Restricted....... Inhalation hazard
formulations. to humans.
Sodium fluoroacetate........... All solutions and dry ......do.......... ......do......... Acute oral
baits. toxicity. Hazard
to nontarget
organisms. Use
and accident
history.
Strychnine..................... All dry baits, ......do.......... ......do......... Acute oral
pellets and powder toxicity. Hazard
formulations greater to nontarget
than 0.5 pct. avain species.
Use and accident
history.
All dry baits, All uses calling ......do......... Hazard to
pellets and powder for burrow nontarget
formulations. builders. organisms.
All dry baits, All uses except ......do......... Do.
pellets and powder subsoil.
formulations 0.5 pct
and below.
......do............. All subsoil uses.. Unclassified.....
Sulfotepp...................... Sprays and smoke All uses.......... Restricted....... Inhalation hazard
generators. to humans.
Zinc Phosphide................. All formulations 2% All domestic uses Unclassified.....
and less. and non-domestic
uses in and
around buildings.
All dry formulations
60% and greater..
All uses.......... Restricted....... Acute inhalation
toxicity.
All bait formulations Non-domestic ......do......... Hazard to non-
outdoor uses target
(other than organisms.
around buildings).
All dry formulations Domestic uses..... ......do......... Acute oral
10% and greater. toxicity.
----------------------------------------------------------------------------------------------------------------
\1\ ``Under evaluation'' means no classification decision has been made and the use/formulation in question is
still under active review within EPA.
\2\ Percentages given are the total of dioxathion plus related compounds.
\3\ (Note--M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the
required additional training.)
[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46
FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4,
1988; 60 FR 32096, June 19, 1995]
[[Page 40]]
Subparts J-T [Reserved]
Subpart U_Registration Fees
Source: 53 FR 19114, May 26, 1988, unless otherwise noted.
Sec. 152.400 Purpose.
Subpart U prescribes fees to be charged for the pesticide regulatory
activities set forth in Sec. 152.403 as performed by the Environmental
Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202)
and provisions regarding their payment.
Sec. 152.401 Inapplicability of fee provisions to applications filed
prior to October 1, 1997.
No fee required by this subpart U shall be levied with respect to
any application filed during the period beginning on October 25, 1988,
and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to
FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).
[53 FR 11923, Mar. 22, 1989]
Sec. 152.403 Definitions of fee categories.
(a) New chemical registration review means review of an application
for registration of a pesticide product containing a chemical active
ingredient which is not contained as an active ingredient in any other
pesticide product that is registered under FIFRA at the time the
application is made.
(b) New biochemical and microbial registration review means review
of an application for registration of a biochemical or microbial
pesticide product containing a biochemical or microbial active
ingredient not contained in any other pesticide product that is
registered under FIFRA at the time the application is made. For purposes
of this subpart, the definitions of biochemical and microbial pesticides
contained in Sec. 158.65 (a) and (b) of this chapter shall apply.
(c) New use pattern registration review means review of an
application for registration, or for amendment of a registration
entailing a major change to the use pattern of an active ingredient
contained in a product registered under FIFRA or pending Agency decision
on a prior application at the time of application. For purposes of this
paragraph, examples of major changes include but are not limited to,
changes from non-food to food use, outdoor to indoor use, ground to
aerial application, terrestrial to aquatic use, and non-residential to
residential use.
(d) Old chemical registration review means review of an application
for registration of a new product containing active ingredients and uses
which are substantially similar or identical to those currently
registered or for which an application is pending Agency decision.
(e) Amendment review means review of any application requiring
Agency approval to amend the registration of a currently registered
product, or for which an application is pending Agency decision, not
entailing a major change to the use pattern of an active ingredient.
(f) Experimental use permit review means review of an application
for a permit pursuant to section 5 of FIFRA to apply a limited quantity
of a pesticide in order to accumulate information necessary to register
the pesticide. The application may be for a new chemical or for a new
use of an old chemical. The fee applies to such experimental uses of a
single unregistered active ingredient (no limit on the number of other
active ingredients, in a tank mix, already registered for the crops
involved) and no more than three crops. This fee does not apply to
experimental use permits required for small-scale field testing of
microbial pest control agents (40 CFR 172.3).
Sec. 152.404 Fee amounts.
The fee prescribed by the following table must be submitted with
each application for registration, amended registration or experimental
use permit. Fees will be adjusted annually in accordance with Sec.
152.410. The Agency may waive or refund fees in accordance with Sec.
152.412.
Table--Registration Fees
------------------------------------------------------------------------
Type of review Fee
------------------------------------------------------------------------
New chemical................................................. $184,500
New biochemical or microbial................................. 64,000
New use pattern.............................................. 33,800
Experimental use permit...................................... 4,500
Old chemical................................................. 4,000
[[Page 41]]
Amendment.................................................... 700
------------------------------------------------------------------------
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
Sec. 152.406 Submission of supplementary data.
Applicants may submit data to supplement pending applications
without incurring additional charges if the proper fee was paid with
submission of the original application and subsequent submissions of
supplementary data do not constitute a change in the type of
registration action requested.
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
Sec. 152.408 Special considerations.
(a) If two or more applicants apply for a new chemical registration
for products having the same active ingredient and each applicant
provides a set of data in support of the registration developed
independently of the other applicants' data, then each applicant
submitting an independent set of data shall be charged the full new
chemical registration review fee.
(b) If two or more applicants apply for a new chemical registration
for products having the same active ingredient and the applicants have
jointly developed or paid for the joint development of a common set of
data to support their applications for registration, then each applicant
shall be charged an equal share of the total fee for review of the
applications for all of the subject products. The total fee will include
the sum of the new chemical registration review fee for one product and
one old chemical registration review fee for each additional product.
(c) If an application is received for registration of a product that
contains two or more new chemical active ingredients and a different set
of generic data is required by the Agency for each new chemical for the
purpose of registration, the applicant will be required to pay the full
new chemical registration review fee for each active ingredient.
Sec. 152.410 Adjustment of fees.
(a) The fee schedule will be adjusted annually by the same
percentage as the percent change in the Federal General Schedule (GS)
pay scale. Such adjustments will be published in the Federal Register as
a final rule and will be effective 30 days or more after promulgation.
(b) Processing costs and fees will be reviewed periodically and
changes will be made to the schedule as necessary. Such adjustments will
be published for notice and comment in the Federal Register.
Sec. 152.412 Waivers and refunds.
(a) Refunds. If an application is not accepted for processing
because it is incomplete, the fee, less $1,200 for handling and initial
review (or the amount of the fee, whichever is less), shall be returned.
If an application is withdrawn by the applicant before significant
Agency scientific review has begun, the fee, less $1,200, shall be
returned. If an unacceptable or withdrawn petition is resubmitted, it
shall be accompanied by the fee that would be required if it were
submitted for the first time.
(b) Waiver of fees for activities initiated by the Agency. The
Agency may waive fees for amended registrations where the amendment has
been initiated solely by the Agency. The Agency retains sole discretion
in determining when this fee will be waived. The announcement of the fee
waiver will accompany the EPA request for an amendment. The Agency will
not approve any individual requests for waivers of EPA-initiated
activity fees.
(c) Waiver of fees for activities initiated by applicants. Upon
request by an applicant, together with the supporting documentation or
justification described in this paragraph, the Agency may waive or
refund fees in whole or in part. A request for waiver must be submitted
in accordance with Sec. 152.414(a). An application for which a waiver
of fees has been requested will not be accepted for review until the
waiver has been granted, or until the waiver has been denied and
thereafter the proper fee has been submitted.
(1) Minor use. Fees may be waived for applications limited to minor
uses that
[[Page 42]]
lack commercial feasibility for the pesticide applicant. An applicant
requesting a waiver on this basis must provide supporting information
that demonstrates that anticipated revenues from the uses that are the
subject of the application would be insufficient to pay back the cost of
the fee. The burden of proof of the reasonableness of this estimate
rests with the applicant.
(2) IR-4. Fees will be waived for registration actions that are
determined to be specifically associated with tolerance petitions
submitted by the Inter-Regional Research Project Number 4 (IR-4 program)
when such waiver is deemed by the Agency to be in the public interest.
(3) Severe economic impact. The Agency may waive two-thirds of any
cumulative registration fee payment in a 12-month period following
completion of the applicant's most recent fiscal year that exceeds 3
percent of the applicant's pesticide sales in its most recently
completed fiscal year. An applicant requesting a waiver on this basis
must provide documentation (e.g. copy of an annual report, or income tax
forms filed with the Internal Revenue Service, or if needed, a notarized
statement signed by a corporate officer regarding annual pesticide
sales) demonstrating that:
(i) The company applying had less than $40 million in gross revenue
(including all revenue sources) in the most recently concluded fiscal
year of operation, and a single fee would constitute more than 3 percent
of the applicant's gross revenue from pesticide sales in the most
recently completed fiscal year of operation, or
(ii) The company applying had less than $40 million in gross revenue
(including all revenue sources) in the most recently concluded fiscal
year of operation, and the cumulative registration fees paid during the
12 months following the applicant's most recently completed fiscal year,
including any registration fees paid for the applicant for which a
waiver is requested, constitute more than 3 percent of the applicant's
gross revenue from pesticide sales in the most recently concluded fiscal
year of operation.
(iii) The Agency will not grant such a waiver if it determines that
the entity submitting the application has been formed or manipulated to
qualify for such a waiver.
(4) Public interest. The Agency, in its discretion, may waive in
whole or in part any of the fees established herein in the public
interest. Examples include, but are not limited to, pesticides offering
unique advantages for reducing public health risks, those that
significantly reduce a current environmental risk, or a product with
extraordinary utility for use in Integrated Pest Management (IPM).
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]
Sec. 152.414 Procedures.
(a) Procedures for requesting a waiver. (1) A request for a waiver
must be submitted in writing at the time the application is submitted to
the Environmental Protection Agency, Office of Pesticide Programs,
Registration Division (7505C), 1200 Pennsylvania Ave., NW., Washington,
DC 20460.
(2) A payment of $1,200 for processing the waiver or the amount of
the actual fee, whichever is less, must be submitted simultaneously to
the address set forth in paragraph (b) of this section. This fee will be
refunded (or applied to any resulting partial fee) if the waiver is
granted. Payment of fees for the registration activities, in contrast to
the waiver fee, shall not be required until the Agency makes a
determination on the waiver request. Since the actual fee is submitted
to an address different than the one to which the waiver request is
submitted, a copy of the payment document must be submitted with the
waiver request that is submitted to the Washington, DC address set forth
in paragraph (a)(1) of this section. No fee is required from a person
who has no financial interest in the application.
(b) Procedures for payment of fees. All fees required by this
section must be paid by money order, bank draft, or certified check
drawn to the order of the Environmental Protection Agency. All payment
of fees must be forwarded to the Environmental Protection Agency,
Headquarters Accounting Operations Branch, Office of Pesticide Programs
(Registration Fees), P.O. Box
[[Page 43]]
360277M, Pittsburgh, PA 15251. The payments should be specifically
labeled ``Registration Fees'' and should be accompanied only by a copy
of the registration application form or the experimental use permit
application form, as appropriate. An application will not be accepted
for processing until the required fees have been submitted.
(c) Procedures for submitting application and supporting data. The
application, along with supporting data, shall be forwarded within 30
days of payment to the Washington DC address set forth in paragraph
(a)(1) of this section.
[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993; 69
FR 39864, July 1, 2004]
Subparts V-Y [Reserved]
Subpart Z_Devices
Sec. 152.500 Requirements for devices.
(a) A device is defined as any instrument or contrivance (other than
a firearm) intended for trapping, destroying, repelling, or mitigating
any pest or any other form of plant or animal life (other than man and
other than a bacterium, virus, or other microorganism on or in living
man or living animals) but not including equipment used for the
application of pesticides (such as tamper-resistant bait boxes for
rodenticides) when sold separately therefrom.
(b) A device is not required to be registered under FIFRA sec. 3.
The Agency has issued a policy statement concerning its authority and
activities with respect to devices, which was published in the Federal
Register of November 19, 1976 (41 FR 51065). A device is subject to the
requirements set forth in:
(1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to
labeling;
(2) FIFRA sec. 7 and part 167 of this chapter, with respect to
establishment registration and reporting;
(3) FIFRA sec. 8 and part 169 of this chapter, with respect to books
and records;
(4) FIFRA sec. 9, with respect to inspection of establishments;
(5) FIFRA sec. 12, 13, and 14, with respect to violations,
enforcement activities, and penalties;
(6) FIFRA sec. 17, with respect to import and export of devices;
(7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging;
and
(8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to
declare devices subject to certain provisions of the Act.
[53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]
PART 153_REGISTRATION POLICIES AND INTERPRETATIONS--Table of Contents
Subparts A-F [Reserved]
Subpart G_Determination of Active and Inert Ingredients
Sec.
153.125 Criteria for determination of pesticidal activity.
Subpart H_Coloration and Discoloration of Pesticides
153.140 General.
153.155 Seed treatment products.
Subparts I-M [Reserved]
Authority: 7 U.S.C. 136w.
Subparts A-F [Reserved]
Subpart G_Determination of Active and Inert Ingredients
Source: 53 FR 15989, May 4, 1988, unless otherwise noted.
Sec. 153.125 Criteria for determination of pesticidal activity.
(a) An ingredient will be considered an active ingredient if it is
contained in a pesticide product and:
(1) The ingredient has the capability by itself, and when used as
directed at the proposed use dilution, to function as a pesticide; or
(2) The ingredient has the ability to elicit or enhance a pesticidal
effect in another compound whose pesticidal activity is substantially
increased due to the interaction of the compounds. Compounds which
function simply to enhance or prolong the activity of an
[[Page 44]]
active ingredient by physical action, such as stickers and other
adjuvants, are not generally considered to be active ingredients.
(b) Normally the applicant will determine and state in his
application whether an ingredient is active or inert with respect to
pesticidal activity. The Agency, as part of its review of an application
for registration, or in conjunction with the Registration Standard or
Special Review process, may require any ingredient, to be designated as
an active ingredient if the Agency finds that it meets the criteria in
paragraph (a) of this section. Conversely, the Agency may determine that
any ingredient designated as active by an applicant is an inert
ingredient if it fails to meet those criteria.
(c) If an ingredient is designated as an active ingredient, it must
be identified in the label ingredients statement. If an ingredient is
designated as an inert ingredient, it must be included as part of the
total inert ingredients in the label ingredients statement.
(d) Designation of a substance as a pesticidally inert ingredient
does not relieve the applicant or registrant of other requirements of
FIFRA with respect to labeling of inert ingredients or submission of
data, or from the requirements of the Federal Food, Drug, and Cosmetic
Act with respect to tolerances or other clearance of ingredients.
[53 FR 15989, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]
Subpart H_Coloration and Discoloration of Pesticides
Source: 53 FR 15990, May 4, 1988, unless otherwise noted.
Sec. 153.140 General.
Section 25(c)(5) of the Act authorizes the Administrator to
prescribe regulations requiring coloration or discoloration of any
pesticide if the Administrator determines that such requirements are
feasible and necessary for the protection of health and the environment.
This subpart describes those pesticide products which must be colored or
discolored.
[60 FR 32096, June 19, 1995]
Sec. 153.155 Seed treatment products.
(a) Pesticide products intended for use in treating seeds must
contain an EPA-approved dye to impart an unnatural color to the seed,
unless appropriate tolerances or other clearances have been established
under the Federal Food, Drug and Cosmetic Act for residues of the
pesticide.
(b) The following products are exempt from the requirement of
paragraph (a) of this section:
(1) Products intended and labeled for use solely by commercial seed
treaters, provided that the label bears a statement requiring the user
to add an EPA-approved dye with the pesticide during the seed treatment
process.
(2) Products intended and labeled for use solely as at-planting or
hopper box treatments.
(3) Products which are gaseous in form or are used as fumigants.
(c) EPA-approved dyes for seed treatment are listed in:
(1) Sections 180.910, 180.920, and 180.950 if an exemption from the
requirement of a tolerance has been established.
(2) Section 180.2010 if EPA has determined that residues of the dye
will be present, if at all, at levels that are below the threshold of
regulation.
(3) Section 180.2020 if it has been determined that no tolerance or
exemption from the requirement of a tolerance is needed as a result of a
determination by EPA that the use is unlikely to result in residues in
food/feed.
[53 FR 15990, May 4, 1988, as amended at 66 FR 66772, Dec. 27, 2001; 69
FR 23117, Apr. 28, 2004]
Subparts I-M [Reserved]
PART 154_SPECIAL REVIEW PROCEDURES--Table of Contents
Subpart A_General Provisions
Sec.
154.1 Purpose and scope.
154.3 Definitions.
154.5 Burden of persuasion in determinations under this part.
154.7 Criteria for initiation of Special Review.
154.10 Petitions to begin the Special Review process.
154.15 Docket for the Special Review.
[[Page 45]]
Subpart B_Procedures
154.21 Preliminary notification to registrants and applicants for
registration.
154.23 Proposed decision not to initiate a Special Review.
154.25 Public announcement of final decision whether to initiate a
Special Review.
154.26 Comment opportunity.
154.27 Meetings with interested persons.
154.29 Informal public hearings.
154.31 Notices of Preliminary Determination.
154.33 Notice of Final Determination.
154.34 Expedited procedures.
154.35 Finality of determinations.
Authority: 15 U.S.C. 136a, d, and w.
Source: 50 FR 49015, Nov. 27, 1985, unless otherwise noted.
Subpart A_General Provisions
Sec. 154.1 Purpose and scope.
(a) Purpose. The purpose of the Special Review process is to help
the Agency determine whether to initiate procedures to cancel, deny, or
reclassify registration of a pesticide product because uses of that
product may cause unreasonable adverse effects on the environment, in
accordance with sections 3(c)(6) and 6 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA). The process is intended to
ensure that the Agency assesses risks that may be posed by pesticides,
and the benefits of use of those pesticides, in an open and responsive
manner. The issuance of a Notice of Special Review means that the Agency
has determined that one or more uses of a pesticide may pose significant
risks and that, following completion of the Special Review process, the
Agency expects to initiate formal proceedings seeking to cancel, deny,
reclassify, or require modifications to the registration of the
product(s) in question unless it has been shown during the Special
Review that the Agency's initial determination was erroneous, that the
risks can be reduced to acceptable levels without the need for formal
proceedings, or that the benefits of the pesticide's use outweigh the
risks. Following completion of the Special Review process, a pesticide
in question may be returned to the registration process.
(b) Scope. This part sets forth the substantive standards for
initiating a Special Review of a pesticide product and the procedures
for initiating and conducting the Special Review.
Sec. 154.3 Definitions.
(a) Except as otherwise defined in this section, terms defined in
section 2 of FIFRA shall have the same definitions for purposes of this
part.
(b) The term Act or FIFRA means the Federal Insecticide, Fungicide,
and Rodenticide Act, as amended, 7 U.S.C. 136 et seq.
(c) The term Administrator means the Administrator of the
Environmental Protection Agency or any officer or employee thereof to
whom authority has been delegated to act for the Administrator.
(d) The term confidential business information means trade secrets
or confidential commercial or financial information under FIFRA section
10(b) or 5 U.S.C. 552(b) (3) or (4).
(e) The term other significant evidence means factually significant
information that relates to the uses of the pesticide and their adverse
risk to man or to the environment but does not include evidence based
only on misuse of the pesticide unless such misuse is widespread and
commonly recognized practice.
(f) The term person means an applicant, registrant, manufacturer,
pesticide user, environmental group, labor union, or other individual or
group of individuals interested in pesticide regulation.
(g) The term pesticide use means a use of a pesticide (discribed in
terms of the application site and other applicable identifying factors)
that is included in the labeling of a pesticide product which is
registered, or for which an application for registration is pending, and
the terms and conditions (or proposed terms and conditions) of
registration for the use.
(h) Terms and conditions of registration means the terms and
conditions governing lawful sale, distribution, and use approved in
conjunction with registration, including labeling, use classification,
composition, and packaging.
(i) The term validated test means a test determined by the Agency to
have
[[Page 46]]
been conducted and evaluated in a manner consistent with accepted
scientific procedures
Sec. 154.5 Burden of persuasion in determinations under this part.
In making determinations under this part the Administrator shall be
guided by the principle that the burden of persuasion that a pesticide
product is entitled to registration or continued registration for any
particular use or under any particular set of terms and conditions of
registration is always on the proponent(s) of registration.
Sec. 154.7 Criteria for initiation of Special Review.
(a) The Administrator may conduct a Special Review of a pesticide
use if he determines, based on a validated test or other significant
evidence, that the use of the pesticide (taking into account the
ingredients, impurities, metabolites, and degradation products of the
pesticide):
(1) May pose a risk of serious acute injury to humans or domestic
animals.
(2) May pose a risk of inducing in humans an oncogenic, heritable
genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or
delayed toxic effect, which risk is of concern in terms of either the
degree of risk to individual humans or the number of humans at some
risk, based upon:
(i) Effects demonstrated in humans or experimental animals.
(ii) Known or predicted levels of exposure of various groups of
humans.
(iii) The use of appropriate methods of evaluating data and relating
such data to human risk.
(3) May result in residues in the environment of nontarget organisms
at levels which equal or exceed concentrations acutely or chronically
toxic to such organisms, or at levels which produce adverse reproductive
effects in such organisms, as determined from tests conducted on
representative species or from other appropriate data.
(4) May pose a risk to the continued existence of any endangered or
threatened species designated by the Secretary of the Interior or the
Secretary of Commerce under the Endangered Species Act of 1973, as
amended.
(5) May result in the destruction or other adverse modification of
any habitat designated by the Secretary of the Interior or the Secretary
of Commerce under the Endangered Species Act as a critical habitat for
any endangered or threatened species.
(6) May otherwise pose a risk to humans or to the environment which
is of sufficient magnitude to merit a determination whether the use of
the pesticide product offers offsetting social, economic, and
environmental benefits that justify initial or continued registration.
(b) In making any determination that a pesticide use satisfies one
of the criteria for issuance of a Special Review specified by paragraph
(a) of this section, the Administrator shall consider available evidence
concerning both the adverse effect in question and the magnitude and
scope of exposure of humans and nontarget organisms associated with use
of the pesticide.
Sec. 154.10 Petitions to begin the Special Review process.
The Administrator may evaluate a pesticide use under the criteria of
Sec. 154.7 either on his own initiative, or at the suggestion of any
interested person.
Sec. 154.15 Docket for the Special Review.
(a) Establishment of the docket. When the Agency first notifies
registrants privately that it is considering issuance of a Notice of
Special Review for a pesticide, it shall establish a docket concerning
that particular pesticide.
(b) Contents of the docket. For each pre-Special Review or Special
Review, the docket shall contain:
(1) The Notice of Special Review, any Notice of Preliminary
Determination, and any Notice of Final Determination.
(2) Any notice issued under Sec. 154.21 or Sec. 154.23.
(3) Any documents (other than information claimed to be confidential
business information) referred to by the Agency in those notices as
relied upon by the Agency in reaching its determination.
(4) Copies of all written comments or materials (other than
information
[[Page 47]]
claimed to be confidential business information) responding to any
notice furnished under Sec. 154.21 or Sec. 154.23 or submitted at any
time during the Special Review process by any person outside of
government.
(5) Any written response to the Notice of Preliminary Determination
from the Secretary of Agriculture or the Scientific Advisory Panel.
(6) A transcript of all public meetings held by the Scientific
Advisory Panel or conducted by the Agency for the purpose of gathering
information.
(7) A memorandum describing each meeting between Agency personnel
and any person or party outside of government which concerns a pending
pre-Special Review or Special Review decision. Each such memorandum
shall be based on notes taken at the meeting and shall specify the date
and time of the meeting, the participants and their affiliations, who
requested the meeting, the subject matter of the meeting, and the person
who prepared the memorandum. Except for information claimed to be
confidential business information, each memorandum shall describe fully
and accurately all significant positions taken, arguments made, and
facts presented by each participant in the meeting, and shall identify
all documents, proposals, or other materials distributed or exchanged at
the meeting. Any discussion of claimed confidential business information
shall be identified in meeting notes and referenced in the memorandum.
(8) All comments, correspondence, or other materials concerning a
pending pre-Special Review or Special Review decision provided to the
Agency by a person or party outside of government (other than
information claimed to be confidential business information).
(9) All documents, proposals, or other materials concerning a
pending pre-Special Review or Special Review decision, provided by the
Agency to any person or party outside of government (other than
information claimed to be confidential business information).
(c) Assertion of confidential business information claims. (1)
Information, comments, data, or other written material submitted to the
Agency concerning a Special Review may be claimed by the submitter to be
confidential business information. The burden of identifying claimed
confidential business information rests with the submitter, or, in
meetings, with the participants who wish to assert a claim of
confidentiality.
(2) To assert a claim of confidentiality for all or any part of a
written submission concerning a Special Review, the submitter must
furnish three copies of the material. Two copies must be complete, with
claimed confidential business information clearly marked in the text.
Items in the document that are claimed confidential should be numbered
consecutively throughout the text. The third copy must have the claimed
confidential business information excised from the text without closing
up or paraphrasing the remaining text. The deletions should be
consecutively numbered to correspond to the numbering of the complete
copies. Each copy must be marked on the cover as to whether it contains
claimed confidential business information.
(3) Any written material concerning a Special Review received by the
Agency that is not marked as confidential will be deemed to be
nonconfidential, and may be made available through the public docket or
otherwise disclosed without prior notice to the submitter.
(d) Placement of materials in the docket. Any memorandum identified
under paragraph (b)(7) of this section shall be placed in the docket
within 10 working days of the subject meeting. Materials identified
under paragraph (b)(8) of this section shall be placed in the docket
within 10 working days of receipt by the Office of Pesticide Programs,
or within 15 working days of receipt by the Office of Pesticide Programs
if the submitter has asserted a confidential business information claim
concerning the submittal. Materials identified under paragraph (b)(9) of
this section shall be placed in the docket within 15 working days of
transmittal to such person or party outside of government.
(e) Index. The Agency shall prepare and maintain a current index of
all materials included in the docket. The index will include a list
identifying, for each meeting between Agency personnel and a person or
party outside of government for which a memorandum
[[Page 48]]
has been prepared, the date, the subject, participants, and person who
requested the meeting. The index will also list any document included in
the docket by its title, its source, its recipient, and the date it was
received or provided by the Agency.
(f) Access to the docket. (1)(i) For each chemical in Special
Review, the docket shall be available for public inspection and copying
and its index kept current and made available to the public on request.
The docket and index for any pesticide for which the Agency has issued a
pre-Special Review notification under Sec. 154.21 will only be made
available for public inspection and copying following issuance of a
proposed decision not to start a Special Review under Sec. 154.23, a
Notice of Special Review under Sec. 154.25(c), or as otherwise
specified in Sec. 154.34.
(ii) The docket and index will be available at the Program
Management and Support Division, in Rm. 236, Crystal Mall 2,
1801 South Bell St., Arlington, VA, from 8 a.m. to 4 p.m. Monday through
Friday, excluding legal holidays.
(2) Information contained in the docket shall not be disclosed to
the public to the extent that FIFRA or any other statute or regulation
(including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its
disclosure.
(3) The Agency will distribute a compendium of indices for new
materials in the public docket by mail, on a monthly basis, to those
members of the public who have specifically requested such material. The
Agency will announce the availability of docket indices both annually in
the Federal Register and in each Federal Register Notice concerning pre-
Special Review or Special Review for specific pesticides. The Agency may
also periodically require parties on the mailing list to renew their
previous request for such materials.
[50 FR 49015, Nov. 27, 1985, as amended at 69 FR 39864, July 1, 2004]
Subpart B_Procedures
Sec. 154.21 Preliminary notification to registrants and applicants for
registration.
(a) Preliminary notification. If the Administrator decides that he
may initiate a Special Review of a pesticide use, he shall send written
notice by certified mail to the affected registrant(s) and applicant(s)
setting forth his decision and a general description of the information
which supports it.
(b) Comment opportunity. Reg is trant(s) and applicant(s) will be
allowed 30 days from the receipt of no ti fi ca tion to respond in
writing to dispute the validity of the Agency's con clu sions or to
present information in response to the notification.
Sec. 154.23 Proposed decision not to initiate a Special Review.
If the Administrator proposes not to initiate a Special Review after
having given notice under Sec. 154.21, he shall issue a proposed
decision for publication in the Federal Register. The proposal shall
include a description of the concerns which were the original basis for
placement of the pesticide in pre-Special Review status and the Agency's
rationale for its proposed decision, announce the availability of a
public docket, and provide a period generally not less than 30 days for
submission of comments. A notice under Sec. 154.25(b) may not be
published unless it has been preceded by a notice under this section. A
proposal under this section shall not be based on the benefits of use of
a pesticide product.
Sec. 154.25 Public announcement of final decision whether to initiate a
Special Review.
(a) The Administrator shall evaluate the available information and
the comments received in response to the notice under Sec. 154.21 and
any notice issued under Sec. 154.23, and shall issue for publication in
the Federal Register a notice under paragraph (b) or (c) of this
section.
(b) If the Administrator determines after having given notice under
Sec. 154.21 not to initiate a Special Review, he shall issue his
decision for publication
[[Page 49]]
in the Federal Register with a statement of reasons.
(c) If the Administrator determines after having given notice under
Sec. 154.21 that one or more of the risk criteria set forth in Sec.
154.7 have been satisfied, the Agency shall issue a notice for
publication in the Federal Register which shall include:
(1) Identification of the pesticide uses for which a Special Review
has been initiated and an identification of the criteria which have been
satisfied.
(2) A brief discussion of the Agency's reasons for determining that
the criteria have been satisfied.
(3) A statement indicating that EPA has established a docket for the
Special Review, the contents of the docket, the location of the docket,
and the times during which the docket will be available for inspection
and copying.
(4) An invitation to all interested persons to submit further
information concerning the risks and benefits associated with each use
of the pesticide subject to the Special Review.
(5) A brief description of the Special Review process and a
statement that registrants and applicants bear an affirmative burden of
supporting registration of a pesticide product.
(6) A date by which information in response to the Agency's request
for further information must be submitted.
(d) In his discretion, the Administrator may request that the
Scientific Advisory Panel hold a public meeting to review the scientific
issues related to the Special Review.
Sec. 154.26 Comment opportunity.
After issuance of a Notice of Special Review that applies to a use
of a pesticide product (or category of products), any person may submit
to the Agency any information, argument, or both, pertinent to:
(a) Whether the use of a pesticide product satisfies any of the
Sec. 154.7 risk criteria, with respect to the composition, labeling,
packaging, and restrictions on use of the product as currently
registered.
(b) Whether the use of a pesticide product would satisfy any of the
Sec. 154.7 risk criteria if its composition, labeling, packaging, and
restrictions on use were approved in accordance with an application for
registration or amended registration pending before the Agency. For
further information see Sec. 154.27(b).
(c) Whether any risks posed by the use or proposed use of the
product that satisfy the Sec. 154.7 risk criteria are unreasonable,
taking into account the economic, social, and environmental costs and
benefits of the use of the product.
(d) What regulatory action, if any, the Agency should take with
respect to the use of the product.
Sec. 154.27 Meetings with interested persons.
(a) In the Special Review process, to assure openness and
responsiveness, no person or party outside of government will be
afforded special or preferential access to Agency Special Review
decisionmakers or to the Agency's Special Review process. At the same
time, however, Agency personnel are free to meet and otherwise
communicate with persons or parties outside of government, including
registrants and manufacturers, users, trade unions, environmental groups
and other interested persons, to obtain information, exchange views,
explore factual and substantive positions, or discuss regulatory options
concerning Special Review decisions.
(b) Meetings between EPA and any person or party outside of
government will not result in undue delay in reaching Special Review
decisions. During such meetings, the Agency will not commit to take any
particular action concerning a pending decision. The Agency may receive
and consider information and recommendations from persons or parties
outside of government; however, the Agency will make the final
administrative decision on a wholly independent basis and in accordance
with law.
(c) Any interested person may ask to meet with Agency officials to
discuss factual information available to the Agency, to present any
factual information, to respond to presentations by other persons, or to
discuss what regulatory actions should be taken regarding a pesticide
which is or may be the subject of a Special Review. If, at its
[[Page 50]]
discretion, the Agency holds such meetings with any person outside of
government concerning a use of a pesticide product, the Agency will
prepare and file in the docket a memorandum of such meeting, meeting the
requirements specified in Sec. 154.15(b)(7).
(d) Meetings described in this section may include meetings held
after issuance of a Notice of Special Review with any registrant who
proposes to change voluntarily the composition, packaging, and labeling,
or other terms and conditions of registration of his pesticide product
in a way which he believes would reduce the risks of use of the product
so that it would no longer meet or exceed the risk criteria of Sec.
154.7. Meetings for this purpose will be most helpful and productive for
both registrants and the Agency if they are requested by registrants
shortly after the issuance of the Notice of Special Review.
(e) If the Agency meets with any person or party outside of
government concerning a pending Special Review decision, the Agency will
not issue a final Special Review decision until 30 days after inclusion
of a memorandum concerning that meeting in the public docket. During
those 30 days, any person or party may submit written comments to the
Agency regarding the subject matter of the meeting in question. The
Agency may issue a final Special Review decision without allowing this
30-day period if expedited action is necessary to protect public health
or the environment, or if the Agency has invited other parties with
potentially opposing viewpoints to the meeting in question (e.g.,
registrants, users, labor, and environmental groups).
(f) The Agency may decline to meet subsequently with any person or
party who asserts unreasonable confidential business information claims
pursuant to Sec. 154.15(c) for the purpose of circumventing the
docketing procedures described in Sec. 154.15(b).
Sec. 154.29 Informal public hearings.
(a) Timing. At any time after issuance of a Notice of Special Review
and prior to issuance of a Notice of Final Determination, the
Administrator may conduct an informal public hearing to gather relevant
information or otherwise assist Agency decisionmaking.
(b) Federal Register notice. The Administrator shall issue a notice
for publication in the Federal Register of any informal public hearing
to be held under this section. The notice shall contain the following
information:
(1) The time, date, and place of the hearing.
(2) A brief description of the procedures governing participation in
the hearing by interested persons.
(3) The issues to be considered at the hearing.
(c) Transcript. A verbatim transcript of the hearing shall be
prepared and filed in the public docket.
Sec. 154.31 Notices of Preliminary Determination.
The Administrator shall prepare a Notice of Preliminary
Determination after the close of the comment period on a Notice of
Special Review.
(a) Contents of notice. The Notice of Preliminary Determination
shall respond to all significant comments submitted in response to the
Notice of Special Review. For each use of a pesticide product that was
the subject of the Notice of Special Review, the Notice of Preliminary
Determination shall also include, as appropriate:
(1) A determination whether the use satisfies any of the risk
criteria set forth in Sec. 154.7, and a discussion of the reasons for
the determination.
(2) A determination of whether any changes in the composition,
packaging, labeling, or restrictions on use of a pesticide product that
were proposed in an application for new or amended registration
submitted after issuance of the Notice of Special Review would reduce
the risk so that the use no longer would satisfy any of the risk
criteria in Sec. 154.7.
(3) If the use satisfies any of the risk criteria set forth in Sec.
154.7, a determination of whether the adverse effects posed by the use
are unreasonable, taking into account the economic, social, and
environmental costs and benefits of the use of the product, and a
discussion of reasons for the determination.
[[Page 51]]
(4) If the use is determined to pose an unreasonable adverse effect,
a statement of the regulatory action, if any, which the Agency intends
to initiate with respect to the use, and a discussion of the reasons for
initiating that regulatory action.
(5) A statement that the Administrator is requesting comments from
the Secretary of Agriculture and the Scientific Advisory Panel on the
notices and analysis specified in paragraph (b) of this section, and
that the notices and analysis are available on request.
(6) Instructions to interested persons on how to submit comments
(including the deadline for submission of comments).
(7) The location of the docket under Sec. 154.15 and the times
during which the docket will be available for inspection and copying.
(b) Referral to Secretary of Agriculture and Scientific Advisory
Panel. If the Administrator proposes to cancel, deny, or change the
classification of the registration of a pesticide product which is the
subject of a Special Review, or to hold a hearing under FIFRA section
6(b)(2) on whether to take any of those actions, he shall:
(1) Prepare a proposed form of a Notice of Intent to Cancel, a
Notice of Intent to Deny Registration, a Notice of Intent to Hold a
Hearing, and/or a Notice of Intent to Change Classification, as
appropriate.
(2) Prepare an Agricultural Impact Analysis, analyzing the impact of
the proposed action on production and prices of agricultural
commodities, retail food prices, and otherwise on the agricultural
economy.
(3) Send the proposed notices and analysis to the Secretary of
Agriculture and the Scientific Advisory Panel for comment, as provided
by the Act.
(4) Send the Notice of Preliminary Determination and the other
notices and analysis prepared under this section to all registrants and
applicants for registration of products that are subject to the Special
Review.
(c) Publication. The Agency shall issue the Notice of Preliminary
Determination for publication in the Federal Register.
Sec. 154.33 Notice of Final Determination.
(a) Publication and notice to registrants and applicants. The
Administrator shall prepare a Notice of Final Determination after the
close of the comment period on a Notice of Preliminary Determination. As
necessary, the Administrator shall also prepare Notices of Intent to
Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under
FIFRA section 6(b)(2), or Notices of Intent to Change Classification.
(b) Contents. The Notice of Final Determination shall include:
(1) For each pesticide use subject to the Notice of Preliminary
Determination, the Agency's final determination with respect to each
use, along with a discussion of the reasons for the determination.
(2) Any comments submitted by the Secretary of Agriculture or the
Scientific Advisory Panel, and the responses of the Administrator to
these comments.
(3) The response of the Administrator to any significant public
comments submitted on the Notice of Preliminary Determination.
(4) Instructions to registrants, applicants for registration, and
other interested persons concerning the procedures which will be used to
implement any regulatory action which the Administrator has decided
upon, including instructions concerning how to request hearings, if
hearings are available as of right under the Act or have been made
available by the Administrator under the Act.
(5) The location of the docket under Sec. 154.15 and the times
during which the docket will be available for inspection and copying.
(c) Publication and notification of registrants and applicants. The
Notice of Final Determination and any Notice of Intent to Cancel, Notice
of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to
Change Classification shall be published in the Federal Register. If the
Administrator issues a Notice of Intent to Cancel, Notice of Denial,
Notice of Intent to Hold a Hearing, or Notice of Intent to Change
Classification, such notice, along with the Notice of Final
Determination, also shall be sent by certified mail to all affected
registrants and applicants.
[[Page 52]]
Sec. 154.34 Expedited procedures.
(a) The Agency may elect to issue a Notice of Special Review and a
Notice of Preliminary Determination simultaneously; or, to initiate
cancellation, suspension, or denial proceedings concerning a pesticide
or any of its uses without first conducting a Special Review or issuing
a Notice of Preliminary Determination.
(b) If the Agency elects to issue a simultaneous Notice of Special
Review and Notice of Preliminary Determination, the Agency will make the
docket for that decision available for public inspection no more than 3
months after the Agency privately notifies the registrant of its risk
concerns pursuant to Sec. 154.21(a).
Sec. 154.35 Finality of determinations.
(a) The Administrator will not approve an application for
registration or amended registration of a pesticide product except by
use of the procedures specified in paragraph (c) of this section, if:
(1) The application proposes registration of a product for a use
which earlier had been the subject of a notice under Sec. 154.21(a);
(2) After the Administrator issued the notice, he determined not to
initiate a Special Review, because of a proposal by an applicant for
registration or amended registration to change the terms and conditions
of registration of the product in a way which would reduce the risk
sufficiently to eliminate the need for a Special Review; and
(3) The application for registration or amended registration now
proposes that the terms and conditions which served as the basis of the
earlier determination be eliminated, or be modified in a way which might
increase the risk which was the subject of the notice under Sec.
154.21(a).
(b) The Administrator will not approve an application for
registration or amended registration of a pesticide product except by
use of the procedures specified in paragraph (c) of this section, if:
(1) The application proposed registration of a product for a use
which earlier had been the subject of a Notice of Special Review issued
under Sec. 154.25;
(2) After the Administrator issued that Notice, he determined not to
issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal
by an applicant for registration or amended registration to change the
terms and conditions of registration of the product in a way which would
reduce the risk sufficiently to eliminate the need for issuance of a
notice under FIFRA section 3(c)(6) or 6(b); and
(3) The application for registration or amended registration now
proposes that the terms and conditions of registration which served as
the basis for the earlier determination now be eliminated or be modified
in a way which might increase the risk which was the subject of the
Notice of Special Review.
(c) An application to which paragraph (a) or (b) of this section
applies may not be approved until:
(1) The Administrator issues a notice for publication in the Federal
Register which describes why the application is subject to the
provisions of this section, states that the Administrator proposes to
approve the application and his reasons, solicits public comment on
whether the application should be approved, and provides a period not
less than 30 days for comments to be submitted; and
(2) If any substantive comments are submitted in response to the
notice, the Administrator issues a second notice for publication in the
Federal Register responding to the comments.
PART 155_REGISTRATION STANDARDS--Table of Contents
Subpart A [Reserved]
Subpart B_Docketing and Public Participation Procedures
Sec.
155.23 Definitions.
155.25 Schedule.
155.27 Agency review of data.
155.30 Meetings and communications.
155.32 Public docket.
155.34 Notice of availability.
Authority: 7 U.S.C. 136 through 136y.
Source: 50 FR 49001, Nov. 27, 1985, unless otherwise noted.
Subpart A [Reserved]
[[Page 53]]
Subpart B_Docketing and Public Participation Procedures
Sec. 155.23 Definitions.
For the purposes of this part, confidential business information
means trade secrets or confidential commercial or financial information
under FIFRA sec. 10(b) or 5 U.S.C. 552(b) (3) or (4).
Sec. 155.25 Schedule.
EPA will issue annually in the Federal Register a notice listing the
pesticides (or groups of pesticides) for which Registration Standards
are currently being developed. The list will include pesticides for
which a Registration Standard is scheduled for issuance within the next
year, and the approximate sequence of issuance. The list may also
include pesticides for which a Registration Standard will be under
development during the upcoming year, but which are not scheduled for
issuance until the succeeding year. The notice will invite comment and
submission of information on the individual pesticides on the list.
Sec. 155.27 Agency review of data.
EPA will independently (or using the services of disinterested
contractors or consultants) review available data in preparation for the
development of a Registration Standard, and will be responsible for the
drafting of the Registration Standard based on such data reviews. The
Agency will not permit registrants to prepare, or assist in the
preparation of, data reviews or other Registration Standard documents.
The Agency may, however, meet with registrants to discuss its pending
reviews, decisions, or documents, in accordance with the meeting
procedures in Sec. 155.30, and the docketing procedures in Sec.
155.32.
Sec. 155.30 Meetings and communications.
EPA personnel may, upon their own initiative or upon request of any
interested person or party, meet or communicate with persons or parties
outside of government concerning a Registration Standard under
development. Such meetings or communications will conform to the
following policies and procedures:
(a) Purpose. Meetings and communications may be for the purpose of
receiving and considering information, exchanging views, exploring
factual and substantive positions, discussing regulatory options or for
any other purpose deemed appropriate by the Agency in its deliberations
concerning development of a Registration Standard. The Agency will not
commit to take any particular action concerning a Registration Standard
under development during discussions with any person or party outside of
government. The Agency will make its final administrative decision on a
wholly independent basis, and in accordance with law.
(b) Meetings with persons or parties outside of government. Requests
by responsible persons or parties outside of government to meet with
Agency personnel concerning a Registration Standard under development
should be directed in writing to the Registration Division. Reasonable
requests will ordinarily be granted on a timely basis. EPA will decide
the time and place of such meetings, and the Agency personnel who will
attend. EPA may decline to meet with persons or parties who assert
unreasonable claims of confidential business information for the purpose
of circumventing the docketing procedures in Sec. 155.32. EPA may also
decline to meet if the number or frequency of meetings would delay
unduly the issuance of the Registration Standard. Further, no person or
party outside government will be accorded special or preferential access
to Agency pesticide decisionmaking or to the Agency's decisional
process.
(c) Information submitted to the Agency concerning a Registration
Standard under development. (1) Information, comments, data, or other
written material submitted to the Agency at any time concerning a
Registration Standard under development may be claimed by the submitter
to be confidential business information. The burden of identifying
claimed confidential business information rests with the submitter, or,
in meetings, with the participants from outside of government who wish
to assert a claim of confidentiality.
[[Page 54]]
(2) To assert a claim of confidentiality for all or any part of a
written submission concerning a Registration Standard under development,
the submitter must furnish three copies of the material. Two copies must
be complete, with claimed confidential business information clearly
marked in the text. Items in the document that are claimed confidential
should be numbered consecutively throughout the document. The third copy
must have the claimed confidential business information excised from the
text without closing up or paraphrasing the remaining text. The
deletions should be consecutively numbered to correspond to the
numbering of the complete copies. Each copy must be marked on the cover
as to whether it contains claimed confidential business information.
(3) Any written material received by the Agency that is not marked
as confidential will be deemed to be non con fi den tial, and may be
made available through the public docket or otherwise disclosed without
prior notice to the submitter.
(d) Memorandum of meeting. For each meeting with a person or party
outside of government, the Agency will prepare, based on notes taken at
the meeting, a memorandum of the meeting. The memorandum will be
prepared within 10 working days of the meeting and will include all of
the following information:
(1) The date and time of the meeting.
(2) The name of the person who requested the meeting.
(3) The names and affiliations of the participants.
(4) The subject matter of the meeting.
(5) A full and accurate description of all significant positions
taken, facts presented, and arguments made by each participant (except
that any discussion of claimed confidential business information will be
identified in meeting notes, and referenced in the memorandum).
(6) Identification of all documents, proposals, or other materials
(other than information claimed to be confidential business information)
distributed or exchanged at the meeting.
(7) The name of the person who prepared the memorandum.
[50 FR 49001, Nov. 27, 1985, as amended at 58 FR 34203, June 23, 1993]
Sec. 155.32 Public docket.
(a) When created. (1) A docket will be created for each Registration
Standard under development when the Agency begins review of data for the
Registration Standard or upon publication of the notice described in
Sec. 155.25 setting out the list and sequence of Registration
Standards, whichever is earlier. The Agency will announce in its annual
schedule notice the dockets that are available for Registration
Standards under development.
(2) If the Agency notifies registrants privately in accordance with
40 CFR 154.21 that one or more risk criteria set forth in 40 CFR 154.7
(leading to a special review) may have been exceeded, that notification
and any subsequent communications concerning that notification will be
placed in a separate docket pertaining to possible special review in
accordance with the provisions of Sec. 154.15.
(b) Contents of docket. The docket will contain, within the time
frames indicated, all of the following documents and information (except
that information claimed to be confidential business information will
not be included):
(1) An index of its contents (refer to paragraph (c) of this
section).
(2) A copy of each comment received in response to the notice
described in Sec. 155.25 that pertains to a pesticide for which the
notice indicated a Registration Standard was under development (within
10 working days after receipt by the Agency, or 15 working days if the
submitter has asserted a confidential business information claim
concerning the material).
(3) A copy of each memorandum of a meeting between the Agency and
persons or parties outside of government, prepared in accordance with
Sec. 155.30(d) (within 10 working days after the meeting).
(4) A copy of each document, comment, item of correspondence or
other written material concerning the Registration Standard submitted to
the Agency by any person or party outside of government, whether in a
meeting
[[Page 55]]
or separately (within 10 working days after receipt, or 15 working days
if the submitter has asserted a confidential business information claim
concerning the material).
(5) A copy of each document, proposal, or other item of written
material concerning the Registration Standard provided by the Agency to
any person or party outside of government (within 15 working days after
the item is made available to such person or party).
(6) A copy of the Registration Standard;
(7) With respect to a Registration Standard for which the Agency has
determined that a substantially complete chronic health and teratology
data base exists, a copy of the Federal Register notice concerning
availability of a proposed Registration Standard, and a copy of each
comment received in response to that notice (within 10 working days
after receipt by the Agency, or 15 working days if the submitter has
asserted a confidential business information claim concerning the
material).
(8) A copy of the Federal Register notice announcing the issuance of
the Registration Standard (within 10 working days after the publication
of the notice).
(c) Index of the docket. The Agency will establish and keep current
an index to the docket for each Registration Standard. The index will
include, but is not limited to:
(1) A list of each meeting between the Agency and any person or
party outside of government, containing the date and subject of the
meeting, the names of participants and the name of the person requesting
the meeting.
(2) A list of each document in the docket by title, source or
recipient(s), and the date the document was received or provided by the
Agency.
(d) Availability of docket and indices. (1) The Agency will make
available to the public for inspection and copying the docket and index
for any Registration Standard.
(2) The Agency will establish and maintain a mailing list of persons
who have specifically requested that they receive indices for
Registration Standard dockets. On a quarterly basis, EPA will distribute
the indices of new materials placed in the public docket to these
persons. Annually, EPA will require that persons on the list renew their
requests for inclusion on the list.
(3) The Agency will issue annually in the Federal Register (in
conjunction with the annual schedule notice specified in Sec. 155.25) a
notice announcing the availability of docket indices.
(4) Each Federal Register notice of availability of a Registration
Standard will announce the availability of the docket index for that
Standard.
Sec. 155.34 Notice of availability.
(a) The Agency will issue in the Federal Register a notice
announcing the issuance and availability of Registration Standard which:
(1) Concerns a previously unregistered active ingredient; or
(2) Concerns a previously registered active ingredient, and the
Registration Standard states that registrants will be required (under
FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not
limited to, chronic feeding, oncogenicity and reproduction) or
teratology studies.
(b) Interested persons may submit comments concerning any
Registration Standard described by paragraph (a) of this section at any
time.
(c) The Agency will issue in the Federal Register a notice
announcing the availability of, and providing opportunity for comment
on, each proposed Registration Standard which concerns a previously
registered active ingredient for which the Agency has determined that a
substantially complete chronic health and teratology data base exists.
Following the comment period and issuance of the Registration Standard,
the Agency will issue in the Federal Register a notice of availability
of the Registration Standard.
PART 156_LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES
--Table of Contents
Subpart A_General Provisions
Sec.
156.10 Labeling requirements.
Subparts B-C [Reserved]
[[Page 56]]
Subpart D_Human Hazard and Precautionary Statements
156.60 General.
156.62 Toxicity Category.
156.64 Signal word.
156.66 Child hazard warning.
156.68 First aid statement.
156.70 Precautionary statements for human hazards.
156.78 Precautionary statements for physical or chemical hazards.
Subpart E_Environmental Hazard and Precautionary Statements
156.80 General.
156.85 Non-target organisms.
Subparts F-J [Reserved]
Subpart K_Worker Protection Statements
156.200 Scope and applicability.
156.203 Definitions.
156.204 Modification and waiver of requirements.
156.206 General statements.
156.208 Restricted-entry statements.
156.210 Notification-to-workers statements.
156.212 Personal protective equipment statements.
Authority: 7 U.S.C. 136-136y.
Subpart A_General Provisions
Sec. 156.10 Labeling requirements.
(a) General--(1) Contents of the label. Every pesticide products
shall bear a label containing the information specified by the Act and
the regulations in this part. The contents of a label must show clearly
and prominently the following:
(i) The name, brand, or trademark under which the product is sold as
prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or person for
whom produced as prescribed in paragraph (c) of this section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph (e)
of this section;
(v) The producing establishment number as prescribed in paragraph
(f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of this
section;
(vii) Hazard and precautionary statements as prescribed in subpart D
of this part for human and domestic animal hazards and subpart E of this
part for environmental hazards.
(viii) The directions for use as prescribed in paragraph (i) of this
section; and
(ix) The use classification(s) as prescribed in paragraph (j) of
this section.
(2) Prominence and legibility. (i) All words, statements, graphic
representations, designs or other information required on the labeling
by the Act or the regulations in this part must be clearly legible to a
person with normal vision, and must be placed with such conspicuousness
(as compared with other words, statements, designs, or graphic matter on
the labeling) and expressed in such terms as to render it likely to be
read and understood by the ordinary individual under customary
conditions of purchase and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text shall
appear in the English language. However, the Agency may require or the
applicant may propose additional text in other languages as is
considered necessary to protect the public. When additional text in
another language is necessary, all labeling requirements will be applied
equally to both the English and other-language versions of the labeling.
(4) Placement of Label--(i) General. The label shall appear on or be
securely attached to the immediate container of the pesticide product.
For purposes of this section, and the misbranding provisions of the Act,
``securely attached'' shall mean that a label can reasonably be expected
to remain affixed during the foreseeable conditions and period of use.
If the immediate container is enclosed within a wrapper or outside
container through which the label cannot be clearly read, the label must
also be securely attached to such outside wrapper or container, if it is
a part of the package as customarily distributed or sold.
[[Page 57]]
(ii) Tank cars and other bulk containers--(A) Transportation. While
a pesticide product is in transit, the appropriate provisions of 49 CFR
parts 170-189, concerning the transportation of hazardous materials, and
specifically those provisions concerning the labeling, marking and
placarding of hazardous materials and the vehicles carrying them, define
the basic Federal requirements. In addition, when any registered
pesticide product is transported in a tank car, tank truck or other
mobile or portable bulk container, a copy of the accepted label must be
attached to the shipping papers, and left with the consignee at the time
of delivery.
(B) Storage. When pesticide products are stored in bulk containers,
whether mobile or stationary, which remain in the custody of the user, a
copy of the label of labeling, including all appropriate directions for
use, shall be securely attached to the container in the immediate
vicinity of the discharge control valve.
(5) False or misleading statements. Pursuant to section 2(q)(1)(A)
of the Act, a pesticide or a device declared subject to the Act pursuant
to Sec. 152.500, is misbranded if its labeling is false or misleading
in any particular including both pesticidal and non-pesticidal claims.
Examples of statements or representations in the labeling which
constitute misbranding include:
(i) A false or misleading statement concerning the composition of
the product;
(ii) A false or misleading statement concerning the effectiveness of
the product as a pesticide or device;
(iii) A false or misleading statement about the value of the product
for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the pesticide
or device is recommended or endorsed by any agency of the Federal
Government;
(vi) The name of a pesticide which contains two or more principal
active ingredients if the name suggests one or more but not all such
principal active ingredients even though the names of the other
ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false or
misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as ``safe,'' ``nonpoisonous,''
``noninjurious,'' ``harm less'' or ``nontoxic to humans and pets'' with
or without such a qualifying phrase as ``when used as directed''; and
(x) Non-numerical and/or comparative statements on the safety of the
product, including but not limited to:
(A) ``Contains all natural ingredients'';
(B) ``Among the least toxic chemicals known''
(C) ``Pollution approved''
(6) Final printed labeling. (i) Except as provided in paragraph
(a)(6)(ii) of this section, final printed labeling must be submitted and
accepted prior to registration. However, final printed labeling need not
be submitted until draft label texts have been provisionally accepted by
the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly onto
glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or trademark
under which the pesticide product is sold shall appear on the front
panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through registration
or supplemental registration as an additional name pursuant to Sec.
152.132.
(c) Name and address of producer, registrant, or person for whom
produced. An unqualified name and address given on the label shall be
considered as the name and address of the producer. If the registrant's
name appears on the label and the registrant is not the producer, or if
the name of the
[[Page 58]]
person for whom the pesticide was produced appears on the label, it must
be qualified by appropriate wording such as ``Packed for * * *,''
``Distributed by * * *,'' or ``Sold by * * *'' to show that the name is
not that of the producer.
(d) Net weight or measure of contents. (1) The net weight or measure
of content shall be exclusive of wrappers or other materials and shall
be the average content unless explicitly stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement shall be
in terms of liquid measure at 68 [deg]F (20 [deg]C) and shall be
expressed in conventional American units of fluid ounces, pints, quarts,
and gallons.
(3) If the pesticide is solid or semisolid, viscous or pressurized,
or is a mixture of liquid and solid, the net content statement shall be
in terms of weight expressed as avoirdupois pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., ``1 pound 10 ounces'' rather than ``26
ounces.''
(5) In addition to the required units specified, net content may be
expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation unavoidable
in good manufacturing practice. Variation below a stated minimum is not
permitted. In no case shall the average content of the packages in a
shipment fall below the stated average content.
(e) Product registration number. The registration number assigned to
the pesticide product at the time of registration shall appear on the
label, preceded by the phrase ``EPA Registration No.,'' or the phrase
``EPA Reg. No.'' The registration number shall be set in type of a size
and style similar to other print on that part of the label on which it
appears and shall run parallel to it. The registration number and the
required identifying phrase shall not appear in such a manner as to
suggest or imply recommendation or endorsement of the product by the
Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase ``EPA Est.'',
of the final establishment at which the product was produced may appear
in any suitable location on the label or immediate container. It must
appear on the wrapper or outside container of the package if the EPA
establishment registration number on the immediate container cannot be
clearly read through such wrapper or container.
(g) Ingredient statement--(1) General. The label of each pesticide
product must bear a statement which contains the name and percentage by
weight of each active ingredient, the total percentage by weight of all
inert ingredients; and if the pesticide contains arsenic in any form, a
statement of the percentages of total and water-soluble arsenic
calculated as elemental arsenic. The active ingredients must be
designated by the term ``active ingredients'' and the inert ingredients
by the term ``inert ingredients,'' or the singular forms of these terms
when appropriate. Both terms shall be in the same type size, be aligned
to the same margin and be equally prominent. The statement ``Inert
Ingredients, none'' is not required for pesticides which contain 100
percent active ingredients. Unless the ingredient statement is a
complete analysis of the pesticide, the term ``analysis'' shall not be
used as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient statement
is normally required on the front panel of the label. If there is an
outside container or wrapper through which the ingredient statement
cannot be clearly read, the ingredient statement must also appear on
such outside container or wrapper. If the size or form of the package
makes it impracticable to place the ingredient statement on the front
panel of the label, permission may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel with
other text on the panel on which it appears, and must be clearly
distinguishable from and must not be placed in the body of other text.
(3) Names to be used in ingredient statement. The name used for each
ingredient shall be the accepted common name, if there is one, followed
by the chemical name. The common name
[[Page 59]]
may be used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case will the
use of a trademark or proprietary name be permitted unless such name has
been accepted as a common name by the Administrator under the authority
of section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients shall
be stated in terms of weight-to-weight. The sum of percentages of the
active and the inert ingredients shall be 100. Percentages shall not be
expressed by a range of values such as ``22-25%.'' If the uses of the
pesticide product are expressed as weight of active ingredient per unit
area, a statement of the weight of active ingredient per unit volume of
the pesticide formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given shall be
as precise as possible reflecting good manufacturing practice. If there
may be unavoidable variation between manufacturing batches, the value
stated for each active ingredient shall be the lowest percentage which
may be present.
(6) Deterioration. Pesticides which change in chemical composition
significantly must meet the following labeling requirements:
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear the
following statement in a prominent position on the label: ``Not for sale
or use after [date].''
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name of any
inert ingredient(s) to be listed in the ingredient statement if he
determines that such ingredient(s) may pose a hazard to man or the
environment.
(h) [Reserved]
(i) Directions for Use--(1) General requirements--(i) Adequacy and
clarity of directions. Directions for use must be stated in terms which
can be easily read and understood by the average person likely to use or
to supervise the use of the pesticide. When followed, directions must be
adequate to protect the public from fraud and from personal injury and
to prevent unreasonable adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear on any
portion of the label provided that they are conspicuous enough to be
easily read by the user of the pesticide product. Directions for use may
appear on printed or graphic matter which accompanies the pesticide
provided that:
(A) If required by the Agency, such printed or graphic matter is
securely attached to each package of the pesticide, or placed within the
outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as ``See directions in the
enclosed circular:'' and
(C) The Administrator determines that it is not necessary for such
directions to appear on the label.
(iii) Exceptions to requirement for direction for use. (A) Detailed
directions for use may be omitted from labeling of pesticides which are
intended for use only by manufacturers of products other than pesticide
products in their regular manufacturing processes, provided that:
(1) The label clearly shows that the product is intended for use
only in manufacturing processes and specifies the type(s) of products
involved.
(2) Adequate information such as technical data sheets or bulletins,
is available to the trade specifying the type of product involved and
its proper use in manufacturing processes;
(3) The product will not come into the hands of the general public
except after incorporation into finished products; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling of
pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(1) The label clearly states that the product is for use only by
physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary
[[Page 60]]
to prevent unreasonable adverse effects on man or the environment; and
(3) The product is also a drug and regulated under the provisions of
the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling of
pesticide products which are intended for use only by formulators in
preparing pesticides for sale to the public, provided that:
(1) There is information readily available to the formulators on the
composition, toxicity, methods of use, applicable restrictions or
limitations, and effectiveness of the product for pesticide purposes;
(2) The label clearly states that the product is intended for use
only in manufacturing, formulating, mixing, or repacking for use as a
pesticide and specifies the type(s) of pesticide products involved;
(3) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(4) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use shall
include the following, under the headings ``Directions for Use'':
(i) The statement of use classification as prescribed in paragraph
(j) of this section immediately under the heading ``Directions for
Use.''
(ii) Immediately below the statement of use classification, the
statement ``It is a violation of Federal law to use this product in a
manner inconsistent with its labeling.''
(iii) The site(s) of application, as for example the crops, animals,
areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for dilution,
if required, and type(s) of application apparatus or equipment required.
(vii) The frequency and timing of applications necessary to obtain
effective results without causing unreasonable adverse effects on the
environment.
(viii) Worker protection statements meeting the requirements of
subpart K of this part.
(ix) Specific directions concerning the storage and disposal of the
pesticide and its container, meeting the requirements of 40 CFR part
165. These instructions shall be grouped and appear under the heading
``Storage and Disposal.'' This heading must be set in type of the same
minimum sizes as required for the child hazard warning. (See table in
Sec. 162.10(h)(1)(iv))
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food or
feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) For total release foggers as defined in paragraph (h)(2)(iii)(B)
of this section, the following statements must be included in the
``Directions for Use'':
DO NOT use more than one fogger per room. DO NOT use in small,
enclosed spaces such as closets, cabinets, or under counters or tables.
Do not use in a room 5 ft.x5 ft. or smaller; instead, allow fog to enter
from other rooms. Turn off ALL ignition sources such as pilot lights
(shut off gas valves), other open flames, or running electrical
appliances that cycle off and on (i.e., refrigerators, thermostats,
etc.). Call your gas utility or management company if you need
assistance with your pilot lights.''
(E) For restricted use pesticides, a statement that the pesticide
may be applied under the direct supervision of a certified applicator
who is not physically present at the site of application but nonetheless
available to the person applying the pesticide, unless the Agency has
determined that the pesticide may only be applied under the direct
supervision of a certified applicator who is physically present.
(F) Other pertinent information which the Administrator determines
to be necessary for the protection of man and the environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j) (1) and (2) of this
section. Any pesticide product for which
[[Page 61]]
some uses are classified for general use and others for restricted use
shall be separately labeled according to the labeling standards set
forth in this subsection, and shall be marketed as separate products
with different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted use(s)
except that, if a product has both restricted use(s) and general use(s),
both of these uses may appear on a product labeled for restricted use.
Such products shall be subject to the provisions of paragraph (j)(2) of
this section.
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with the exact
words ``General Classification'' immediately below the heading
``Directions for Use.'' And reference to the general classification that
suggests or implies that the general utility of the pesticide extends
beyond those purposes and uses contained in the Directions for Use will
be considered a false or misleading statement under the statutory
definitions of misbranding.
(2) Restricted Use Classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements of
restricted use classification on the front panel as described below:
(i) Front panel statement of restricted use classification. (A) At
the top of the front panel of the label, set in type of the same minimum
sizes as required for human hazard signal words (see table in paragraph
(h)(1)(iv) of this section), and appearing with sufficient prominence
relative to other text and graphic material on the front panel to make
it unlikely to be overlooked under customary conditions of purchase and
use, the statement ``Restricted Use Pesticide'' shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition to
registration shall appear. If use is restricted to certified
applicators, the following statement is required: ``For retail sale to
and use only by Certified Applicators or persons under their direct
supervision and only for those uses covered by the Certified
Applicator's certification.'' If, however, other regulatory restrictions
are imposed, the Administrator will define the appropriate wording for
the terms of restriction by regulation.
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR 36571, Aug.
21, 1975, as amended at 43 FR 5786, Feb. 9, 1978. Redesignated and
amended at 53 FR 15991, 15999, May 4, 1988; 57 FR 38146, Aug. 21, 1992;
60 FR 32096, June 19, 1995; 63 FR 9082, Feb. 23, 1998; 66 FR 64764, Dec.
14, 2001]
Subparts B-C [Reserved]
Subpart D_Human Hazard and Precautionary Statements
Source: 66 FR 64764, Dec. 14, 2001, unless otherwise noted.
Sec. 156.60 General.
Each product label is required to bear hazard and precautionary
statements for humans and domestic animals (if applicable) as prescribed
in this subpart. Hazard statements describe the type of hazard that may
occur, while precautionary statements will either direct or inform the
user of actions to take to avoid the hazard or mitigate its effects.
(a) Location of statements--(1) Front panel statements. The signal
word, child hazard warning, and, in certain cases, the first aid
statement are required to appear on the front panel of the label, and
also in any supplemental labeling intended to accompany the product in
distribution or sale.
(2) Statements elsewhere on label. Hazard and precautionary
statements not required on the front panel may appear on other panels of
the label, and may be required also in supplemental labeling. These
include, but are not limited to, the human hazard and precautionary
statements, domestic animal statements if applicable, a Note to
Physician, and physical or chemical hazard statements.
(b) Placement and prominence--(1) Front panel statements. All
required front panel warning statements shall be grouped together on the
label, and shall appear with sufficient prominence relative to other
front panel text and graphic material to make them unlikely to be
overlooked under customary conditions of purchase and use.
[[Page 62]]
The table below shows the minimum type size requirements for the front
panel warning statements for various front panel sizes.
Type Sizes for Front Panel Warning Statements
------------------------------------------------------------------------
Point Size
------------------
Signal
Size of Label Front Panel (Square Inches) Word Child
(All Hazard
Capital Warning
Letters)
------------------------------------------------------------------------
5 and under.......................................... 6 6
Over 5 to 10......................................... 10 6
Over 10 to 15........................................ 12 8
Over 15 to 30........................................ 14 10
Over 30.............................................. 18 12
------------------------------------------------------------------------
(2) Other required statements. All other hazard and precautionary
statements must be at least 6 point type.
Sec. 156.62 Toxicity Category.
This section establishes four Toxicity Categories for acute hazards
of pesticide products, Category I being the highest toxicity category.
Most human hazard, precautionary statements, and human personal
protective equipment statements are based upon the Toxicity Category of
the pesticide product as sold or distributed. In addition, toxicity
categories may be used for regulatory purposes other than labeling, such
as classification for restricted use and requirements for child-
resistant packaging. In certain cases, statements based upon the
Toxicity Category of the product as diluted for use are also permitted.
A Toxicity Category is assigned for each of five types of acute
exposure, as specified in the table in this paragraph.
Acute Toxicity Categories for Pesticide Products
----------------------------------------------------------------------------------------------------------------
Hazard Indicators I II III IV
----------------------------------------------------------------------------------------------------------------
Oral LD50....................... Up to and 50 thru 500 5,000
including 50 mg/ 500 mg/kg thru 5,000 mg/kg mg/kg
kg
Dermal LD50..................... Up to and 200 2000 20,000
including 200 mg/ thru 2000 mg/kg thru 20,000 mg/kg mg/kg
kg
Inhalation LC50................. Up to and 0.2 2 thru 20 mg/
including 0.2 mg/ thru 2 mg/liter 20 mg/liter liter
liter
Eye irritation.................. Corrosive; corneal Corneal opacity No corneal No irritation
opacity not reversible within opacity;
reversible within 7 days; irritation
7 days irritation reversible within
persisting for 7 7 days
days
Skin irritation................. Corrosive Severe irritation Moderate Mild or slight
at 72 hours irritation at 72 irritation at 72
hours hours
----------------------------------------------------------------------------------------------------------------
Sec. 156.64 Signal word.
(a) Requirement. Except as provided in paragraph (a)(4), each
pesticide product must bear on the front panel a signal word, reflecting
the highest Toxicity Category (Category I is the highest toxicity
category) to which the product is assigned by any of the five routes of
exposure in Sec. 156.62. The signal word must also appear together with
the heading for the human precautionary statement section of the
labeling (see Sec. 156.70).
(1) Toxicity Category I. Any pesticide product meeting the criteria
of Toxicity Category I for any route of exposure must bear on the front
panel the signal word ``DANGER.'' In addition, if the product is
assigned to Toxicity Category I on the basis of its oral, inhalation or
dermal toxicity (as distinct from skin and eye irritation), the word
``Poison'' must appear in red on a background of distinctly contrasting
color, and the skull and crossbones symbol must appear in immediate
proximity to the word ``Poison.''
(2) Toxicity Category II. Any pesticide product meeting the criteria
of Toxicity Category II as the highest category by any route of exposure
must bear on the front panel the signal word ``WARNING.''
(3) Toxicity Category III. Any pesticide product meeting the
criteria of Toxicity Category III as the highest category by any route
of exposure must bear on the front panel the signal word ``CAUTION.''
(4) Toxicity Category IV. A pesticide product meeting the criteria
of Toxicity Category IV by all routes of exposure is not required to
bear a signal
[[Page 63]]
word. If a signal word is used, it must be ``CAUTION.''
(b) Use of signal words. In no case may a product:
(1) Bear a signal word reflecting a higher Toxicity Category than
indicated by the route of exposure of highest toxicity, unless the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment;
(2) Bear a signal word reflecting a lesser Toxicity Category
associated with a diluted product. Although precautionary statements for
use dilutions may be included on label, the signal word must reflect the
toxicity of the product as distributed or sold; or
(3) Bear different signal words on different parts of the label.
Sec. 156.66 Child hazard warning.
(a) Each pesticide product must bear on the front panel of the label
the statement ``Keep Out of Reach of Children.'' That statement, or any
alternative statement approved by EPA, must appear on a separate line in
close proximity to the signal word, if required. The statement is
required on Toxicity Category IV products that do not otherwise require
a signal word.
(b) In its discretion, EPA may waive the requirement, or require or
permit an alternative child hazard warning, if:
(1) The applicant can demonstrate that the likelihood of exposure of
children to the pesticide during distribution, marketing, storage or use
is remote (for example, an industrial use product); or
(2) The pesticide is approved for use on children (for example, an
insect repellent).
(c) EPA may approve an alternative child hazard warning that more
appropriately reflects the nature of the pesticide product to which
children may be exposed (for example, an impregnated pet collar). In
this case, EPA may also approve placement on other than the front panel.
Sec. 156.68 First aid statement.
(a) Product as sold and distributed. Each product must bear a first
aid statement if the product has systemic effects in Category I, II, or
III, or skin or eye irritation effects in Category I or II.
(b) Product as diluted for use. If the product labeling bears
directions for dilution with water prior to use, the label may also
include a statement describing how the first aid measures may be
modified for the diluted product. Such a statement must reflect the
Toxicity Category(ies) of the diluted product, based upon data for the
route of exposure (or calculations if appropriate). If the labeling
provides for a range of use dilutions, only that use dilution
representing the highest concentration allowed by labeling may be used
as the basis for a statement pertaining to the diluted product. The
statement for a diluted product may not substitute for the statement for
the concentrate, but augments the information provided for the
concentrate.
(c) Heading. The heading of the statement may be ``First Aid'' or
``Statement of Practical Treatment.''
(d) Location of first aid statement. The first aid statement must
appear on the front panel of the label of all products assigned to
Toxicity Category I by any route of exposure. Upon review, the Agency
may permit reasonable variations in the placement of the first aid
statement if a reference such as ``See first aid statement on back
panel'' appears on the front panel. The first aid statement for products
assigned to Toxicity Categories II or III may appear on any panel of the
label.
Sec. 156.70 Precautionary statements for human hazards.
(a) Requirement. Human hazard and precautionary statements as
required must appear together on the label or labeling under the general
heading ``Precautionary Statements'' and under appropriate subheadings
similar to ``Humans and Domestic Animals,'' ``Environmental Hazards''
(see subpart E of this part) and ``Physical or Chemical Hazards.'' The
phrase ``and Domestic Animals'' may be omitted from the heading if
domestic animals will not be exposed to the product.
(b) Content of statements. When data or other information show that
an acute hazard may exist to humans or domestic animals, the label must
bear
[[Page 64]]
precautionary statements describing the particular hazard, the route(s)
of exposure and the precautions to be taken to avoid accident, injury or
toxic effect or to mitigate the effect. The precautionary paragraph must
be immediately preceded by the appropriate signal word.
(c) Typical precautionary statements. The table below presents
typical hazard and precautionary statements. Specific statements
pertaining to the hazards of the product and its uses must be approved
by the Agency. With Agency approval, statements may be augmented to
reflect the hazards and precautions associated with the product as
diluted for use. Refer to Sec. 156.68(b) for requirements for use
dilution statements.
Typical Human Hazard and Precautionary Statements
----------------------------------------------------------------------------------------------------------------
Systemic effects (oral, Sensitizer (There are
Toxicity Category dermal, inhalation Irritation effects no categories of
toxicity) (skin and eye) sensitization.)
----------------------------------------------------------------------------------------------------------------
I Fatal (poisonous) if Corrosive, causes eye If product is a
swallowed [inhaled or and skin damage [or sensitizer: Prolonged
absorbed through skin irritation]. Do or frequently repeated
skin]. Do not breathe not get in eyes on skin contact may cause
vapor [dust or spray skin, or on clothing. allergic reactions in
mist]. Do not get in Wear goggles or face some individuals.
eyes, on skin, or on shield and rubber
clothing. [Front panel gloves when handling.
first aid statement Harmful or fatal if
required.] swallowed. [Front
panel first aid
statement required.]
----------------------------------------------------------------------------------------
II May be fatal if Causes eye [and skin]
swallowed, [inhaled or irritation. Do not get
absorbed through the in eyes, on skin, or
skin]. Do not breathe on clothing. Harmful
vapors [dust or spray if swallowed.
mist]. Do not get in [Appropriate first aid
eyes, on skin, or on statement required.]
clothing. [Appropriate
first aid statement
required.]
----------------------------------------------------------------------------------------
III Harmful if swallowed Avoid contact with
[inhaled or absorbed skin, eyes or
through the skin]. clothing.
Avoid breathing vapors
[dust or spray mist].
Avoid contact with
skin [eyes or
clothing].
[Appropriate first aid
statement required.]
----------------------------------------------------------------------------------------
IV No precautionary No precautionary
statements required statements required.
----------------------------------------------------------------------------------------------------------------
Sec. 156.78 Precautionary statements for physical or chemical hazards.
(a) Requirement. Warning statements on the flammability or explosive
characteristics of the pesticide product are required if a product meets
the criteria in this section. Warning statements pertaining to other
physical/chemical hazards (e.g., oxidizing potential, conductivity,
chemical reactions leading to production of toxic substances) may be
required on a case-by-case basis.
(b) Pressurized products. The table below sets out the required
flammability label statements for pressurized products.
Flammability Statements for Pressurized Products
------------------------------------------------------------------------
Flash point/flame extension of product Required labeling statement
------------------------------------------------------------------------
--Flash point at or below 20 [deg]F Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not puncture
or incinerate container.
Exposure to temperatures
above 130 [deg]F may cause
bursting.
OR
--Flashback at any valve opening
------------------------------------------------------------------------
--Flash point 20 [deg]F to 80 Flammable. Contents under
[deg]F pressure. Keep away from
heat, sparks and open
flame. Do not puncture or
incinerate container.
Exposure to temperatures
above 130 [deg]F may cause
bursting.
OR
[[Page 65]]
--Flame extension more than 18 in. long at
a distance of 6 in from the flame
------------------------------------------------------------------------
All other pressurized products Contents under pressure. Do
not use or store near heat
or open flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130
[deg]F may cause bursting.
------------------------------------------------------------------------
(c) Non-pressurized products. The table below sets out the required
flammability label statements for non-pressurized products.
Flammability Statements for Non-Pressurized Products
------------------------------------------------------------------------
Flash point Required labeling statement
------------------------------------------------------------------------
At or below 20 [deg]F Extremely flammable. Keep
away from fire, sparks and
heated surfaces.
------------------------------------------------------------------------
Greater than 20 [deg]F to 80 [deg]F Flammable. Keep away from
heat and open flame.
------------------------------------------------------------------------
Greater than 80 [deg]F to 150 [deg]F Combustible. Do not use or
store near heat or open
flame.
------------------------------------------------------------------------
(d) Total release fogger products. (1) A total release fogger is
defined as a pesticide product in a pressurized container designed to
automatically release the total contents in one operation, for the
purpose of creating a permeating fog within a confined space to deliver
the pesticide throughout the space.
(2) If a pesticide product is a total release fogger containing a
propellant with a flash point at or below 20 [deg]F, then the following
special instructions must be added to the ``Physical and Chemical
Hazards'' warning statement, in addition to any flammability statement
required by paragraph (b) of this section:
This product contains a highly flammable ingredient. It may cause a fire
or explosion if not used properly. Follow the Directions for Use on this
label very carefully.
(3) A graphic symbol depicting fire, such as illustrated in this
paragraph, or an equivalent symbol, must be displayed along with the
required language adjoining the ``Physical and Chemical Hazards''
warning statement. The graphic symbol must be no smaller than twice the
size of the first character of the human hazard signal word.
[GRAPHIC] [TIFF OMITTED] TR14DE01.011
Highly Flammable Ingredient
Ingrediente Altamente Inflamable
Subpart E_Environmental Hazard and Precautionary Statements
Source: 66 FR 64767, Dec. 14, 2001, unless otherwise noted.
Sec. 156.80 General.
(a) Requirement. Each product is required to bear hazard and
precautionary statements for environmental hazards, including hazards to
non-target organisms, as prescribed in this subpart. Hazard statements
describe the type of hazard that may be present, while precautionary
statements direct or inform the user of actions to take to avoid the
hazard or mitigate its effects.
(b) Location of statements. Environmental hazard and precautionary
statements may appear on any panel of the label and may be required also
in supplemental labeling. The environmental hazard statements must
appear together under the heading ``Environmental Hazards.'' Typically
the statements are grouped as a sub-category within the ``Precautionary
Statements'' section of the labeling.
(c) Type size. All environmental hazard and precautionary statements
must be at least 6 point type.
Sec. 156.85 Non-target organisms.
(a) Requirement. Where a hazard exists to non-target organisms, EPA
may require precautionary statements of the nature of the hazard and the
appropriate precautions to avoid potential accident, injury, or damage.
(b) Examples. The statements in this paragraph illustrate the types
of hazard statements that EPA may require and the circumstances under
which
[[Page 66]]
they are typically required. These statements are not comprehensive;
other statements may be required if more appropriate to the formulation
or use.
(1) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD50 of 100 mg/kg or
less, the statement, ``This pesticide is toxic to wildlife'' is
required.
(2) If a pesticide intended for outdoor use contains an active
ingredient with a fish acute LC50 of 1 ppm or less, the
statement, ``This pesticide is toxic to fish'' is required.
(3) If a pesticide intended for outdoor use contains an active
ingredient with an avian acute oral LD50 of 100 mg/kg or
less, or a subacute dietary LC50 of 500 ppm or less, the
statement, ``This pesticide is toxic to wildlife'' is required.
(4) If either accident history or field studies demonstrate that the
use of the pesticide may result in fatality to birds, fish or mammals,
the statement, ``This pesticide is extremely toxic to wildlife (fish)''
is required.
(5) If a product is intended for or involves foliar application to
agricultural crops, forests or shade trees, or mosquito abatement
treatments, and contains a pesticide toxic to pollinating insects, the
label must bear appropriate label cautions.
(6) If a product is intended for outdoor use other than aquatic
applications, the label must bear the caution, ``Keep out of lakes,
ponds or streams. Do not contaminate water by cleaning of equipment or
disposal of wastes.''
Subparts F-J [Reserved]
Subpart K_Worker Protection Statements
Source: 57 FR 38146, Aug. 21, 1992, unless otherwise noted.
Sec. 156.200 Scope and applicability.
(a) Scope. (1) This subpart prescribes statements that must be
placed on the pesticide label and in pesticide labeling. These
statements incorporate by reference the Worker Protection Standard, part
170 of this chapter. The requirements addressed in these statements are
designed to reduce the risk of illness or injury resulting from workers'
and pesticide handlers' occupational exposures to pesticides used in the
production of agricultural plants on agricultural establishments as
defined in Sec. 170.3 of this chapter. These statements refer to
specific workplace practices designed to reduce or eliminate exposure
and to respond to emergencies that may arise from the exposures that may
occur.
(2) This subpart prescribes interim requirements that must be placed
on the pesticide label and in pesticide labeling. These interim
requirements pertain to restricted-entry intervals, personal protective
equipment, and notification. On a case-by-case basis, these interim
requirements will be reviewed and may be revised during reregistration
or other agency review processes.
(b) Applicability. (1) The requirements of this subpart apply to
each pesticide product that bears directions for use in the production
of any agricultural plant on any agricultural establishment as defined
in Sec. 170.3 of this chapter, or whose labeling reasonably permits
such use.
(2) The requirements of this subpart do not apply to a product that
bears directions solely for uses excepted by Sec. 170.202(b) of this
chapter.
(c) Effective dates. (1) The effective date of this subpart is
October 20, 1992.
(2) No pesticide product bearing labeling amended and revised as
required by this subpart shall be distributed or sold by a registrant
prior to April 21, 1993.
(3) No product to which this subpart applies shall be distributed or
sold without amended labeling by any registrant after April 21, 1994.
(4) No product to which this subpart applies shall be distributed or
sold without amended labeling by any person after October 23, 1995.
Sec. 156.203 Definitions.
Terms in this subpart have the same meanings as they do in the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In
addition, the following terms, as used in this subpart, shall have the
meanings stated below:
[[Page 67]]
Fumigant means any pesticide product that is a vapor or gas or forms
a vapor or gas on application and whose method of pesticidal action is
through the gaseous state.
Restricted-entry interval means the time after the end of a
pesticide application during which entry to the treated area is
restricted.
Sec. 156.204 Modification and waiver of requirements.
(a) Modification on Special Review. If the Agency concludes in
accordance with Sec. 154.25(c) of this chapter that a pesticide should
be placed in Special Review because the pesticide meets or exceeds the
criteria for human health effects of Sec. 154.7(a)(1)(2) or (6) of this
chapter, the Agency may modify the personal protective equipment
required for handlers or early-entry workers or both, the restricted-
entry intervals, or the notification to workers requirements.
(b) Other modifications. The Agency, pursuant to this subpart and
authorities granted in FIFRA sections 3, 6, and 12, may, on its
initiative or based on data submitted by any person, modify or waive the
requirements of this subpart, or permit or require alternative labeling
statements. Supporting data may be either data required by Subdivisions
U or K of the Pesticide Assessment Guidelines or data from medical,
epidemiological, or health effects studies. The Pesticide Assessment
Guidelines contain the standards for conducting acceptable tests,
guidance on evaluation and reporting of data, definition of terms,
further guidance on when data are required, and examples of acceptable
protocols. They are available through the National Technical Information
Service, 5285 Port Royal Rd., Springfield, VA 22161. A registrant who
wishes to modify any of the statements required in Sec. Sec. 156.206,
156.208, 156.210, or 156.212 must submit an application for amended
registration unless specifically directed otherwise by the Agency.
Sec. 156.206 General statements.
(a) Application restrictions. Each product shall bear the statement:
``Do not apply this product in a way that will contact workers or other
persons, either directly or through drift. Only protected handlers may
be in the area during application.'' This statement shall be near the
beginning of the DIRECTIONS FOR USE section of the labeling under the
heading AGRICULTURAL USE REQUIREMENTS.
(b) 40 CFR part 170 reference statement. (1) Each product shall bear
the reference statement: ``Use this product only in accordance with its
labeling and with the Worker Protection Standard, 40 CFR part 170.''
This statement shall be placed on the product label under the heading
AGRICULTURAL USE REQUIREMENTS.
(2) Each product shall bear the statement: ``This standard contains
requirements for the protection of agricultural workers on farms,
forests, nurseries, and greenhouses, and handlers of agricultural
pesticides. It contains requirements for training, decontamination,
notification, and emergency assistance. It also contains specific
instructions and exceptions pertaining to the statements on this label
[in this labeling] about [use any of the following that are applicable]
personal protective equipment, restricted-entry interval, and
notification to workers.'' These statements shall be placed immediately
following the reference statement required by paragraph (b)(1) of this
section, or they shall be placed in the supplemental product labeling
under the heading AGRICULTURAL USE REQUIREMENTS.
(3) If the statements in paragraph (b)(2) of this section are
included in supplemental labeling rather than on the label of the
pesticide container, the container label must contain this statement
immediately following the statement required in paragraph (b)(1) of this
section: ``Refer to supplemental labeling entitled AGRICULTURAL USE
REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for
information about this standard.''
(4) If the statements in paragraph (b)(2) of this section are
included in supplemental labeling, they must be preceded immediately by
the statement in paragraph (b)(1) of this section under the heading
AGRICULTURAL USE REQUIREMENTS in the labeling.
[[Page 68]]
(c) Product-type identification. (1) If the product contains an
organ o phos phate (i.e., an organ o phos phorus ester that inhibits cho
lines ter ase) or an N-methyl car ba mate (i.e., an N-methyl car bamic
acid ester that inhibits cho lines ter ase), the label shall so state.
The statement shall be associated with the product name or product-type
identification or shall be in the STATEMENT OF PRACTICAL TREATMENT or
FIRST AID section of the label.
(2) If the product is a fumigant, the label shall so state. The
identification shall appear:
(i) As part of the product name; or
(ii) Close to the product name, as part of the product-type
identification or as a separate phrase or sentence.
(d) State restrictions. Each product shall bear the statement: ``For
any requirements specific to your State, consult the agency in your
State responsible for pesticide regulation.'' This statement shall be
under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
(e) Spanish warning statements. If the product is classified as
toxicity category I or toxicity category II according to the criteria in
Sec. 156.10(h)(1), the signal word shall appear in Spanish in addition
to English followed by the statement, ``Si Usted no entiende la
etiqueta, busque a alguien para que se la explique a Usted en detalle.
(If you do not understand the label, find some one to explain it to you
in detail.)'' The Spanish signal word ``PELIGRO'' shall be used for
products in toxicity category I, and the Spanish signal word ``AVISO''
shall be used for products in toxicity category II. These statements
shall appear on the label close to the English signal word.
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]
Sec. 156.208 Restricted-entry statements.
(a) Requirement. Each product with a restricted-entry interval shall
bear the following statement: ``Do not enter or allow worker entry into
treated areas during the restricted-entry interval (REI).'' This
statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in
the labeling.
(b) Location of specific restricted-entry interval statements. (1)
If a product has one specific restricted-entry interval applicable to
all registered uses of the product on agricultural plants, the
restricted-entry interval for the product shall appear as a continuation
of the statement required in paragraph (a) of this section and shall
appear as follows: ``of X hours'' or ``of X days'' or ``until the
acceptable exposure level of X ppm or mg/m3 is reached.''
(2) If different restricted-entry intervals have been established
for some crops or some uses of a product, the restricted-entry statement
in paragraph (b)(1) of this section shall be associated on the labeling
of the product with the directions for use for each crop each use to
which it applies, immediately preceded or immediately followed by the
words ``Restricted-entry interval'' (or the letters ``REI'').
(c) Restricted-entry interval based on toxicity of active
ingredient--(1) Determination of toxicity category. A restricted-entry
interval shall be established based on the acute toxicity of the active
ingredients in the product. For the purpose of setting the restricted-
entry interval, the toxicity category of each active ingredient in the
product shall be determined by comparing the obtainable data on the
acute dermal toxicity, eye irritation effects, and skin irritation
effects of the ingredient to the criteria of Sec. 156.10(h)(1). The
most toxic of the applicable toxicity categories that are obtainable for
each active ingredient shall be used to determine the restricted-entry
interval for that product. If no acute dermal toxicity data are
obtainable, data on acute oral toxicity also shall be considered in this
comparison. If no applicable acute toxicity data are obtainable on the
active ingredient, the toxicity category corresponding to the signal
word of any registered manufacturing-use product that is the source of
the active ingredient in the end-use product shall be used. If no acute
toxicity data are obtainable on the active ingredients and no toxicity
category of a registered manufacturing-use product is obtainable, the
toxicity category of the end-use product (corresponding to the signal
word on its labeling) shall be used.
[[Page 69]]
(2) Restricted-entry interval for sole active ingredient products.
(i) If the product contains only one active ingredient and it is in
toxicity category I by the criteria in paragraph (c)(1) of this section,
the restricted-entry interval shall be 48 hours. If, in addition, the
active ingredient is an organophosphorus ester that inhibits
cholinesterase and that may be applied outdoors in an area where the
average annual rainfall for the application site is less than 25 inches
per year, the following statement shall be added to the restricted-entry
interval statement: ``(72 hours in outdoor areas where average annual
rainfall is less than 25 inches a year).''
(ii) If the product contains only one active ingredient and it is in
toxicity category II by the criteria in paragraph (c)(1) of this
section, the restricted-entry interval shall be 24 hours.
(iii) If the product contains only active ingredients that are in
toxicity category III or IV by the criteria in paragraph (c)(1) of this
section, the restricted-entry interval shall be 12 hours.
(3) Restricted-entry interval for multiple active ingredient
products. If the product contains more than one active ingredient, the
restricted-entry interval (including any associated statement concerning
use in arid areas under paragraph (c)(2)(i) of this section) shall be
based on the active ingredient that requires the longest restricted-
entry interval as determined by the criteria in this section.
(d) Exception for fumigants. The criteria for determining
restricted-entry intervals in paragraph (c) of this section shall not
apply to any product that is a fumigant. For fumigants, any existing
restricted-entry interval (hours, days, or acceptable exposure level)
shall be retained. Entry restrictions for fumigants have been or shall
be established on a case-by-case basis at the time of registration,
reregistration, or other Agency review process.
(e) Existing product-specific restricted-entry intervals. (1) A
product-specific restricted-entry interval, based on data collected in
accordance with Sec. 158.390 of this chapter and Subdivision K of the
Pesticide Assessment Guidelines, shall supersede any restricted-entry
interval applicable to the product under paragraph (c) of this section.
(2) Product-specific restricted-entry intervals established for
pesticide products or pesticide uses that are not covered by part 170 of
this chapter shall remain in effect and shall not be placed under the
heading AGRICULTURAL USE REQUIREMENTS in the labeling.
(f) Existing interim restricted-entry intervals. (1) An interim
restricted-entry interval established by the Agency before the effective
date of this subpart will continue to apply unless a longer restricted-
entry interval is required by paragraph (c) of this section.
(2) Existing interim restricted-entry intervals established by the
Agency for pesticide products or pesticide uses not covered by part 170
of this chapter shall remain in effect and shall not be placed under the
heading AGRICULTURAL USE REQUIREMENTS in the labeling.
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]
Sec. 156.210 Notification-to-workers statements.
(a) Requirement. Each product that meets the requirements of
paragraph (b) of this section shall bear the posting and oral
notification statements prescribed below. The statements shall be in the
DIRECTIONS FOR USE section of the labeling under the heading
AGRICULTURAL USE REQUIREMENTS.
(b) Notification to workers of pesticide application. (1) Each
product that contains any active ingredient classified as toxicity
category I for either acute dermal toxicity or skin irritation potential
under the criteria in Sec. 156.10(h)(1) shall bear the statement:
``Notify workers of the application by warning them orally and by
posting warning signs at entrances to treated areas.'' If no acute
dermal toxicity data are obtainable, data on acute oral toxicity of the
active ingredient shall be considered instead. If no data on acute
dermal toxicity, skin irritation potential, or acute oral toxicity are
obtainable on the active ingredient, the toxicity category corresponding
to the signal word of any registered manufacturing-use product that is
the source of the active ingredient in the end-use
[[Page 70]]
product shall be used. If none of the applicable acute toxicity data are
obtainable on the active ingredient and no toxicity category of the
registered manufacturing-use product is obtainable, the toxicity
category of the end-use product corresponding to the product's signal
word shall be used.
(2) Each product that is a fumigant and is registered for use in a
greenhouse (or whose labeling allows use in a greenhouse) shall bear the
statement: ``For greenhouse applications, notify workers of the
application by warning them orally and by posting warning signs outside
all entrances to the greenhouse.''
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]
Sec. 156.212 Personal protective equipment statements.
(a) Requirement. Each product shall bear the personal protective
equipment statements prescribed in paragraphs (d) through (j) of this
section.
(b) Exceptions. (1) If personal protective equipment were required
for a product before the effective date of this subpart, the existing
requirements shall be retained on the labeling wherever they are more
specific or more protective (as specified in EPA guidance materials)
than the requirements in the table in paragraph (e) of this section.
(2) Any existing labeling statement that prohibits the use of gloves
or boots overrides the corresponding requirement in paragraph (e) of
this section and must be retained on the labeling.
(3) If the product labeling contains uses that are not covered by
part 170 of this chapter, the registrant may adopt the personal
protective equipment required in this section for those uses. However,
if the personal protective equipment required in this section would not
be sufficiently protective or would be onerously overprotective for uses
not covered by part 170 of this chapter, the registrant must continue to
apply the existing personal protective equipment requirements to those
uses. The labeling must indicate which personal protective equipment
requirements apply to uses covered by part 170 of this chapter and which
personal protective equipment requirements apply to other uses.
(c) Location of personal protective equipment statements--(1)
Personal protective equipment statements for pesticide handlers.
Personal protective equipment statements for pesticide handlers shall be
in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) section of the labeling.
The required statements may be combined to avoid redundancy as long as
the requirements and conditions under which they apply are identified.
(2) Personal protective equipment statements for early-entry
workers. Personal protective equipment statements for early-entry
workers shall be placed in the DIRECTIONS FOR USE section of the
labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately
after the restricted-entry statement required in Sec. 156.208(a).
(d) Personal protective equipment statements for pesticide handlers.
(1) The table in paragraph (e) of this section specifies minimum
requirements for personal protective equipment (as defined in Sec.
170.240 of this chapter) and work clothing for pesticide handlers. This
personal protective equipment requirement applies to any product that
presents a hazard through any route of exposure identified in the table
(acute dermal toxicity, skin irritation potential, acute inhalation
toxicity, and eye irritation potential).
(2) The requirement for personal protective equipment is based on
the acute toxicity category of the end-use product for each route of
exposure as defined by Sec. 156.10(h)(1). If data to determine the
acute dermal toxicity or the acute inhalation toxicity are not
obtainable, the acute oral toxicity shall be used as a surrogate to
determine the personal protective equipment requirements for that route
of exposure. If data to determine the acute toxicity of the product by a
specific route of exposure (including acute oral toxicity in lieu of
acute dermal or acute inhalation toxicity) are not obtainable, the
toxicity category corresponding to the signal word of the end-use
product shall be used to determine personal protective equipment
requirements for that route of exposure. If the signal
[[Page 71]]
word is ``CAUTION,'' toxicity category III will be used.
(3) The minimum personal protective equipment and work clothing
requirements specified in this section shall be included in a statement
such as the following: ``Applicators and other handlers must wear: (body
protection statement); (glove statement, if applicable); (footwear
statement, if applicable); (protective eyewear statement, if
applicable); (respirator statement, if applicable).'' The format of
statements given in this paragraph is optional, but it is recommended
for clarity.
(e) Summary of personal protective equipment requirements. The
following table 1 summarizes the personal protective equipment
requirements by route of exposure and toxicity category:
Table 1--Minimum Personal Protective Equipment (PPE) and Work Clothing for Handling Activities
----------------------------------------------------------------------------------------------------------------
Toxicity Category of End-Use Product
Route of Exposure -------------------------------------------------------------------------------
I II III IV
----------------------------------------------------------------------------------------------------------------
Dermal Toxicity or Skin Coveralls worn Coveralls worn Long-sleeved shirt Long-sleeved shirt
Irritation Potential\1\ over long-sleeved over short- and long pants and long pants
shirt and long sleeved shirt and
pants short pants
Socks Socks Socks Socks
Chemical-resistant Chemical-resistant Shoes Shoes
footwear footwear
Chemical-resistant Chemical-resistant Chemical-resistant No minimum\4\
gloves\2\ gloves\2\ gloves\2\
Inhalation Toxicity Respiratory Respiratory No minimum\4\ No minimum\4\
protection protection
device\3\ device\3\
Eye Irritation Potential Protective eyewear Protective eyewear No minimum\4\ No minimum\4\
----------------------------------------------------------------------------------------------------------------
\1\ If dermal toxicity and skin irritation potential are in different toxicity categories, protection shall be
based on the more toxic (lower numbered) category.
\2\ For labeling language for chemical-resistant gloves, see paragraph (f) of this section.
\3\ For labeling language for respiratory protection device, see paragraphs (g) and (h) of this section.
\4\ Although no minimum PPE is required by this section for this toxicity category and route of exposure, the
Agency may require PPE on a product-specific basis.
(f) Chemical-resistant gloves labeling statements for pesticide
handlers. If the table in paragraph (e) of this section indicates that
chemical-resistant gloves are required, the glove statement shall be as
specified in paragraph (f)(2), (3), (4), or (5) of this section.
(1) Exception. The registrant shall specify a glove type other than
that selected through the criteria in paragraphs (f)(2) through (5) of
this section if information available to the registrant indicates that
such a glove type is more appropriate or more protective than the glove
type specified in this section. The statement must specify the
particular types of chemical-resistant glove (such as nitrile, butyl,
neoprene, and/or barrier-laminate).
(2) Solid formulations. For products formulated and applied as
solids or formulated as solids and diluted solely with water for
application, the glove statement shall specify: ``waterproof gloves.''
(3) Aqueous-based formulations. For products formulated and applied
as a water-based liquid or formulated as a water-based liquid and
diluted solely with water for application, the glove statement may
specify: ``waterproof gloves'' instead of the statement in paragraph
(f)(4) of this section.
(4) Other liquid formulations. For products formulated or diluted
with liquids other than water, the glove statement shall specify:
``chemical-resistant (such as nitrile or butyl) gloves.''
(5) Gaseous formulations and applications. For products formulated
or applied as gases, any existing glove statement established before the
effective date of this subpart, including any glove prohibition
statement, will continue to apply. If no glove statement or glove
prohibition now exists, the glove statement shall specify ``chemical-
resistant (such as nitrile or butyl) gloves.''
[[Page 72]]
(g) Existing respirator requirement for pesticide handlers on
product labeling--(1) General requirement. If a statement placed on a
product's labeling before the effective date of this subpart indicates
that respiratory protection is required, that requirement for protection
shall be retained. The statement must specify, or be amended to specify,
one of the following respirator types and the appropriate MSHA/NIOSH
approval number prefix:
(i) Dust/mist filtering respirator with MSHA/NIOSH/ approval number
prefix TC-21C; or
(ii) Respirator with an organic-vapor-removing cartridge and a
prefilter approved for pesticides with MSHA/NIOSH approval number prefix
TC-23C or with a canister approved for pesticides with MSHA/NIOSH
approval number prefix TC-14G; or
(iii) Supplied-air respirator with MSHA/NIOSH approval number prefix
TC-19C or self-contained breathing apparatus (SCBA) with MSHA/NIOSH
approval number TC-13F.
(2) Respirator type already specified on labeling. If the existing
respiratory protection requirement specifies a respirator type, it shall
be retained. The respirator statement must be revised, if necessary, to
conform to the wording in paragraph (g)(1) of this section.
(3) Respirator type not already specified on labeling. If the
existing respiratory protection requirement on product labeling does not
specify a respirator type as listed in paragraph (g)(1) of this section,
the specific respirator type shall be that required in the criteria in
paragraphs (g)(3)(ii) through (vi) of this section.
(i) Exception. The registrant shall specify a different type of
respiratory protection device if information, such as vapor pressure
value, is available to the registrant to indicate that the type of
respiratory protection device selected through the criteria in
paragraphs (g)(3)(ii) through (vi) of this section would not be
adequately protective, or might increase risks to the user
unnecessarily.
(ii) Gases applied outdoors. For products that are formulated or
applied as a gas (space and soil fumigants) and that may be used
outdoors, the respiratory protection statement shall be: ``For handling
activities outdoors, use either a respirator with an organic-vapor-
removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH
approval number prefix TC-23C), or a canister approved for pesticides
(MSHA/NIOSH approval number prefix TC-14G).''
(iii) Gases used in enclosed areas. For products that are formulated
or applied as a gas (space and soil fumigants) and that may be used in
greenhouses or other enclosed areas, the respiratory protection
statement shall specify: ``For handling activities in enclosed areas,
use either a supplied-air respirator with MSHA/NIOSH approval number
prefix TC-19C, or a self-contained breathing apparatus (SCBA) with MSHA/
NIOSH approval number TC-13F.''
(iv) Solids. For products that are formulated and applied as solids,
the respiratory protection statement shall specify: ``dust/mist
filtering respirator (MSHA/NIOSH approval number prefix TC-21C).''
(v) Liquids in toxicity category I. For products that are formulated
or applied as liquids, and, as formulated, have an acute inhalation
toxicity (or its surrogate as specified in paragraph (d)(2) of this
section) in category I, the respiratory protection statement shall
specify: ``either a respirator with an organic-vapor-removing cartridge
with a prefilter approved for pesticides (MSHA/NIOSH approval number
prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval number prefix 14G).''
(vi) Liquids in toxicity category II. For products that are
formulated or applied as liquids, and, as formulated, have an acute
inhalation toxicity (or its surrogate as specified in paragraph (d)(2)
of this section) in category II, the respiratory protection statement
shall specify: ``For handling activities during (select uses applicable
to the product: airblast, mistblower, pressure greater than 40 p.s.i.
with fine droplets, smoke, mist, fog, aerosol or direct overhead)
exposures, wear either a respirator with an organic-vapor-removing
cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval
number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH
approval
[[Page 73]]
number prefix 14G). For all other exposures, wear a dust/mist filtering
respirator (MSHA/NIOSH approval number prefix TC-21C).''
(h) New respirator requirement established for pesticide handlers in
this part--(1) General requirement. If the table in paragraph (e) of
this section indicates a respiratory protection device is required, and
existing product labeling has no respiratory protection requirement, the
registrant shall add a respiratory protection statement that specifies
a: ``dust/mist filtering respirator (MSHA/NIOSH approval number prefix
TC-21C).''
(2) Exception. The registrant shall specify a different type of
respiratory protection device if information, such as vapor pressure
value, is available to the registrant to indicate that the type of
respiratory protection device required in paragraph (h)(1) of this
section would not be adequately protective or might increase risks to
the user unnecessarily.
(i) Additional personal protective equipment requirements for
pesticide handlers. In addition to the minimum personal protective
equipment and work clothing requirements given in the table in paragraph
(e) of this section, the labeling statement for any product in toxicity
category I or II on the basis of dermal toxicity or skin irritation
potential (or their surrogate as specified in paragraph (d)(2) of this
section), shall include the following personal protective equipment
instructions, additions, or substitutions as applicable:
(1) If the product is not ready-to-use and there is no existing
requirement for a chemical-resistant suit, the following statement shall
be included: ``Mixers/Loaders: add a chemical-resistant apron.''
(2) If the application of the product may result in overhead
exposure to any handler (for example, applicator exposure during
airblast spraying of orchards or flagger exposure during aerial
application), the following statement shall be included: ``Overhead
Exposure: wear chemical-resistant headgear.''
(3) If any type of equipment other than the product container may be
used to mix, load, or apply the product, and there is no requirement for
a chemical-resistant protective suit, the following statement shall be
included: ``For Cleaning Equipment: add a chemical-resistant apron.''
(j) Personal protective equipment for early-entry workers. This
paragraph specifies minimum requirements for personal protective
equipment (as defined in Sec. 170.240 of this chapter) and work
clothing for early-entry workers.
(1) For all pesticide products, add the statement: ``For early entry
to treated areas that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated, such as
plants, soil, or water, wear: (list the body protection, glove,
footwear, protective eyewear, and protective headgear, if applicable,
statements specified for applicators and other handlers, but omit any
respiratory protection statement).''
(2) If the body protection statement in the personal protective
equipment requirement for handlers specifies a long-sleeved shirt and
long pants, ``coveralls'' must be specified in the statement of personal
protective equipment for early-entry workers.
(3) If there is no statement requiring gloves and no prohibition
against gloves for applicators and other handlers under the heading
HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a
requirement for ``waterproof gloves'' in the statement of personal
protective equipment for early-entry workers.
[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]
PART 157_PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES
--Table of Contents
Subpart A [Reserved]
Subpart B_Child-Resistant Packaging
Sec.
157.20 General.
157.21 Definitions.
157.22 When required.
157.24 Exemptions.
157.27 Unit packaging.
157.30 Voluntary use of child-resistant packaging.
157.32 Standards.
157.34 Certification.
157.36 Recordkeeping.
[[Page 74]]
Authority: 7 U.S.C. 136w.
Source: 51 FR 21286, June 11, 1986 and 51 FR 36692, Oct. 15, 1986,
unless otherwise noted.
Subpart A [Reserved]
Subpart B_Child-Resistant Packaging
Sec. 157.20 General.
This subpart prescribes requirements for child-resistant packaging
of pesticide products and devices. The requirements are established
under the authority of FIFRA section 25(a)(1), which authorizes the
Administrator to issue regulations to carry out the purposes of the Act,
and FIFRA section 25(c)(3), which authorizes the Administrator to
establish standards with respect to the package, container or wrapping
in which a pesticide or device is enclosed in order to protect children
and adults from serious injury or illness resulting from accidental
ingestion or contact with pesticides or devices regulated under the Act.
Sec. 157.21 Definitions.
Terms used in this subpart shall have the following meanings:
(a) Appropriate, when used with respect to child-resistant
packaging, means that the packaging is chemically compatible with the
pesticide contained therein.
(b) Child-resistant packaging means packaging that is designed and
constructed to be significantly difficult for children under 5 years of
age to open or obtain a toxic or harmful amount of the substance
contained therein with in a reasonable time, and that is not difficult
for normal adults to use properly.
(c) Package or packaging means the immediate container or wrapping,
including any attached closure(s), in which the pesticide is contained
for distribution, sale, consumption, use or storage. The term does not
include any shipping or bulk container used for transporting or
delivering the pesticide unless it is the only such package.
(d) Practicable, when used with respect to child-resistant
packaging, means that the packaging can be mass produced and can be used
in assembly line production.
(e) Residential use means use of a pesticide or device:
(1) Directly on humans or pets;
(2) In, on, or around any structure, vehicle, article, surface or
area associated with the household, including but not limited to areas
such as non-agricultural outbuildings, non-commercial greenhouses,
pleasure boats and recreational vehicles; or
(3) In or around any preschool or day care facility.
(f) Technically feasible, when applied to child-resistant packaging,
means that the technology exists to produce the child-resistant
packaging for a particular pesticide.
(g) Unit packaging means a package that is labeled with directions
to use the entire contents of the package in a single application.
Sec. 157.22 When required.
Unless exempted under Sec. 157.24, a pesticide product must be
distributed and sold in child-resistant packaging complying with Sec.
157.32 if it meets both of the following criteria:
(a) Toxicity criterion. Based upon testing with an appropriate test
species, the product meets any of the following toxicity criteria:
(1) The pesticide has an acute oral LD50 of 1.5 g/kg or
less;
(2) The pesticide has an acute dermal LD50 of 2000 mg/kg
or less;
(3) The pesticide has an acute inhalation LC50 of 2 mg/
liter or less;
(4) The pesticide is corrosive to the eye (causes irreversible
destruction of ocular tissue) or causes corneal involvement or
irritation persisting for 21 days or more;
(5) The pesticide is corrosive to the skin (causes tissue
destruction into the dermis and/or scarring) or causes severe skin
irritation (severe erythema or edema) at 72 hours; or
(6) The pesticide or device has such characteristics that, based
upon human toxicological data, use history, accident data or such other
evidence as is available, the Agency determines there is serious hazard
of accidental injury or illness which child-resistant packaging could
reduce; and
[[Page 75]]
(b) Use criterion. The product's labeling either directly recommends
residential use or reasonably can be interpreted to permit residential
use.
Sec. 157.24 Exemptions.
(a) General exemptions. The Agency hereby exempts from the
requirement for child-resistant packaging the following classes of
products:
(1) Products classified for restricted use. (i) A product restricted
to use by or under the supervision of a certified applicator is not
required to be distributed and sold in child-resistant packaging.
(ii) Notwithstanding the exemption in paragraph (a)(1)(i) of this
section, the Agency may require the use of child-resistant packaging for
a product classified for restricted use by or under the direct
supervision of a certified applicator if the Agency determines that the
product poses a risk of serious accidental injury or illness which
child-resistant packaging could reduce. If the Agency makes such a
determination, it will notify the registrant in writing and provide a
short statement of the basis of its determination. The registrant will
then have 30 days to request a hearing on the Agency's determination.
Thereafter the Agency will decide whether to require the product to be
distributed only in child-resistant packaging and will notify the
registrant of its decision.
(2) Products packaged in large sizes. (i) Except as provided by
paragraph (a)(2)(ii) of this section, a product is not required to be in
child-resistant packaging if distributed and sold in the following
sizes:
(A) If the product is a solid product, regardless of pesticide type,
a size of 50 pounds or greater;
(B) If the product is a liquid product intended for use in swimming
pools, a size greater than 7.5 gallons by volume;
(C) If the product is a liquid product intended for any other
pesticide use, a size of 5 gallons or greater by volume;
(D) If the product is packaged as an aerosol (measured by weight),
regardless of pesticide type, a weight of 2 pounds or greater.
(ii) The Agency may require that a product packaged in a size
exceeding that listed in paragraphs (a)(2)(i) (A) through (D) of this
section be distributed and sold only in child-resistant packaging if the
Agency determines that the product is, or is intended to be, distributed
or sold to homeowners or other members of the general public. If the
Agency makes such a determination, it will notify the registrant in
writing and provide a short statement of the basis of its determination.
The registrant will then have 30 days to request a hearing on the
Agency's determination. Thereafter the Agency will decide whether to
require the product to be distributed only in child-resistant packaging
and will notify the registrant of its decision.
(b) Exemptions requiring Agency approval. The Agency may, in
accordance with paragraphs (b) (1) through (3) of this section, grant an
exemption from the requirements of this subpart. An exemption may be
withdrawn in accordance with paragraph (b)(4) of this section.
(1) Requesting an exemption. A request for an exemption must be
submitted to the Agency, and must be accompanied by two copies of the
following information:
(i) The name, address, and telephone number of the requester;
(ii) The name and registration number (or file symbol) of the
product(s) for which the exemption is requested;
(iii) A description of the package and the size(s) for which the
exemption is requested; and
(iv) Documentation supporting the request for exemption, including
the length of time for which the exemption is requested.
(2) Exemption based upon lack of toxicity. The Agency may grant an
exemption from the requirements of this subpart if the registrant or
applicant demonstrates to the Agency's satisfaction that the hazards
indicated by the toxicity criteria in Sec. 157.22(a) are not indicative
of the hazards to man. If granted, an exemption shall apply to other
products of substantially similar composition. A notice will be issued
in the Federal Register stating the nature of and reasons for the
exemption.
[[Page 76]]
(3) Exemption based upon technical factors. The Agency may grant an
exemption from the requirements of this subpart based upon technical
considerations. If granted, the exemption will be for a specified length
of time, and will apply to other products of substantially similar
composition and intended uses. A notice of the granting of an exemption
will be issued in the Federal Register. In considering whether to grant
an exemption, the Agency will consider, among other things, the
following:
(i) Whether the toxicity of the product is such that it should not
be allowed to be distributed or sold except in child-resistant
packaging.
(ii) Whether child-resistant packaging is technically feasible,
practicable, or appropriate. An exemption may be granted if the Agency
determines that any one of these criteria has not been met.
(iii) Whether the composition or use pattern of the product
necessitates a particular form of packaging for proper use.
(iv) Whether child-resistant packaging that is technically feasible,
practicable, and appropriate is available for the product or can
reasonably be made available to the registrant in sufficient quantities
to meet his packaging needs. This determination does not include a
consideration of whether the packaging would be adaptable to a
registrant's existing package type or packaging equipment.
(v) Whether the registrant has made a timely and good faith effort
to obtain child-resistant packaging for the product.
(vi) If child-resistant packaging which is technically feasible,
practicable, and appropriate is not yet available, when such packaging
is likely to be available.
(4) An exemption may be withdrawn by the Agency at any time if the
lack of child-resistant packaging results in serious illnesses or
injuries to children. If the Agency determines that an exemption should
be withdrawn, it will notify the registrant, stating the basis for its
determination. The registrant will then have 30 days to request a
hearing on the Agency's determination. Thereafter the Agency will decide
whether to withdraw the exemption, and will notify the registrant of its
decision.
Sec. 157.27 Unit packaging.
Pesticide products distributed or sold as an aggregate of one or
more unit packages and meeting the criteria of Sec. 157.22 must be
distributed or sold in child-resistant packaging either for each unit
package or for the outer retail container which contains the unit
packages. Child-resistant packaging is not required for both the outer
package and the unit packages unless the Agency determines, on a case-
by-case basis, that it is necessary for risk reduction.
Sec. 157.30 Voluntary use of child-resistant packaging.
A registrant whose product is not required to be in child-resistant
packaging may distribute or sell his pesticide product in child-
resistant packaging. If he does so, that packaging must meet the
standards for child-resistant packaging stated in Sec. 157.32. The
registrant must certify to this effect in accordance with Sec. 157.34,
and must retain the records required by Sec. 157.36.
Sec. 157.32 Standards.
(a) Effectiveness standard. The child-resistant packaging, when
tested by the protocol specified in 16 CFR 1700.20, shall meet the
effectiveness specifications in 16 CFR 1700.15(b).
(b) Compatibility standard. The child-resistant packaging must
continue to meet the effectiveness specifications of paragraph (a) of
this section when in actual use as a pesticide container. This
requirement may be satisfied by appropriate scientific evaluation of the
compatibility of the substance with the child-resistant packaging to
determine that the chemical and physical characteristics of the
pesticide will not compromise or interfere with the proper functioning
of the child-resistant packaging and that the packaging will not be
detrimental to the integrity of the product during storage and use.
(c) Durability standard. The child-resistant packaging must continue
to meet the effectiveness and compatibility standards of paragraphs (a)
and (b) of this section for the reasonably
[[Page 77]]
expected lifetime of the package, taking into account the number of
times the package is customarily opened and closed. This requirement may
be satisfied by appropriate technical evaluation based on physical wear
and stress factors of packaging, the force required for activation, and
other relevant factors.
Sec. 157.34 Certification.
(a) General. (1) The registrant of a pesticide product required to
be in child-resistant packaging shall certify to the Agency that the
package meets the standards of Sec. 157.32.
(2) Certification must be submitted with each application for new
reg istration, if applicable. If the Agency determines, in accordance
with Sec. 157.24(a)(1)(ii), (2)(ii), or (b)(4), that a currently
registered product is required to be packaged in child-resistant
packaging, a certification must be submitted within 6 months after the
Agency finally notifies the registrant of the requirement.
(b) Contents of certification. The certification must contain the
following information:
(1) The name and EPA registration number of the product to which the
certification applies, the registrant's name and address, the date, and
the name, title and signature of the company official making the
certification.
(2) A statement that the packaging that is being used for the
product will meet the standards of Sec. 157.32. The statement, ``I
certify that the packaging that will be used for this product meets the
standards of 40 CFR 157.32,'' will suffice for this purpose.
Sec. 157.36 Recordkeeping.
For as long as the registration of a pesticide product required to
be in child-resistant packaging is in effect, the registrant must retain
the records listed in this section. The registrant must, upon request by
the Agency, make them available to Agency representatives for inspection
and copying, or must submit them to the Agency.
(a) A description of the package, including a description of:
(1) The container and its dimensions and composition.
(2) The closure or child-resistant mechanism, including the name of
its manufacturer and the manufacturer's designation for the closure or
the physical working of the child-resistant packaging mechanism.
(b) A copy of the certification statement required by Sec. 157.34.
(c) One of the following types of records verifying that each
package for the product is child-resistant:
(1) Test data on the package based on the Consumer Product Safety
Commission protocol in 16 CFR 1700.20.
(2) Test data, not conforming to the protocol in 16 CFR 1700.20, or
a set of measurements on the package, together with an explanation as to
why such data or measurements demonstrate that the package is child-
resistant.
(3) Test data, whether or not conforming to the protocol in 16 CFR
1700.20, on a different package, together with an explanation of why
such data demonstrate that the package being used is child-resistant.
(4) Written evidence that verifies that testing on the package has
been conducted according to the protocol in 16 CFR 1700.20. Written
evidence may be one of the following:
(i) A letter or literature from the packaging supplier;
(ii) A letter from the facility that conducted the testing; or
(iii) A specification in the contract between the registrant or
applicant and the packaging supplier;
(5) When the container and closure are purchased separately by the
registrant:
(i) Information of the kinds described in paragraphs (c) (1) through
(4) of this section showing that the closure is child-resistant; and
(ii) A written explanation of why the container is child-resistant;
and
(iii) Information showing that the closure and container are
compatible with each other, and a written explanation of why the
resulting package is child-resistant.
(6) A combination of the records listed in paragraphs (c) (1)
through (5).
[[Page 78]]
(d) Records verifying that the package meets the compatibility and
durability standards of Sec. 157.32(b) and (c).
[51 FR 21286, June 11, 1986 and 51 FR 36692, Oct. 15, 1986, as amended
at 65 FR 39304, June 26, 2000]
PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
Subpart A_General Provisions
Sec.
158.20 Overview.
158.25 Applicability of data requirements.
158.30 Timing of the imposition of data requirements.
158.32 Format of data submission.
158.33 Procedures for claims of confidentiality of data.
158.34 Flagging of studies for potential adverse effects.
158.35 Flexibility of the data requirements.
158.40 Consultation with the Agency.
158.45 Waivers.
158.50 Formulators' exemption.
158.55 Agricultural vs. non-agricultural pesticides.
158.60 Minor uses.
158.65 Biochemical and microbial pesticides.
158.70 Acceptable protocols.
158.75 Requirements for additional data.
158.80 Acceptability of data.
158.85 Revision of data requirements and guidelines.
Subpart B_How To Use Data Tables
158.100 How to determine registration data requirements.
158.101 Required vs. conditionally required data.
158.102 Distinguishing between what data are required and what substance
is to be tested.
158.108 Relationship of Pesticide Assessment Guidelines to data
requirements.
Subpart C_Product Chemistry Data Requirements
158.150 General.
158.153 Definitions.
158.155 Product composition.
158.160 Description of materials used to produce the product.
158.162 Description of production process.
158.165 Description of formulation process.
158.167 Discussion of formation of impurities.
158.170 Preliminary analysis.
158.175 Certified limits.
158.180 Enforcement analytical method.
158.190 Physical and chemical characteristics.
Subpart D_Data Requirement Tables
158.202 Purposes of the registration data requirements.
158.240 Residue chemistry data requirements.
158.290 Environmental fate data requirements.
158.340 Toxicology data requirements.
158.390 Reentry protection data requirements.
158.440 Spray drift data requirements.
158.490 Wildlife and aquatic organisms data requirements.
158.540 Plant protection data requirements.
158.590 Nontarget insect data requirements.
158.640 Product performance data requirements.
158.690 Biochemical pesticides data requirements.
158.740 Microbial pesticides--Product analysis data requirements.
Appendix A to Part 158--Data Requirements for Registration: Use Pattern
Index.
Authority: 7 U.S.C. 136-136y.
Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted.
Subpart A_General Provisions
Sec. 158.20 Overview.
(a) Legal authority. These requirements are promulgated under the
authority of sections 3, 5, 12, and 25 of the Federal Insecticide,
Fungicide and Rodenticide Act, as amended (FIFRA) (7 U.S.C. 136-136y).
(b) Purposes of this part. (1) The primary purpose of this part is
to specify the types and minimum amounts of data and information the
Agency requires in order to make regulatory judgments about the risks
and benefits of various kinds of pesticide products under the criteria
set forth in FIFRA sections 3(c)(5) (C) and (D) and 3(c)(7).
(2) This part also specifies the types and minimum amounts of data
and information the Agency requires to decide whether to approve
applications for experimental use permits under FIFRA section 5.
(3) Finally, this part specifies the types and minimum amounts of
data and information that an applicant for registration, amended
registration, or reregistration must submit or cite in support of an
application in order to satisfy the requirements of FIFRA section
3(c)(1)(D) and sections 3(c)(5)(B) or
[[Page 79]]
3(c)(7). Use of the term ``registration'' in this part will pertain to
new registrations and amended registrations as well as reregistration
accomplished under section 3(g), unless stated otherwise.
(c) Availability of related guidelines. The data requirements for
pesticide registration specified in this part pertain to product
chemistry, residue chemistry, environmental fate, toxicology, reentry
protection, aerial drift evaluation, wildlife and aquatic organisms,
plant protection, nontarget insects, product performance, and
biochemical and microbial pesticides. The standards for conducting
acceptable tests, guidance on evaluation and reporting of data, further
guidance on when data are required, definition of most terms, and
examples of protocols are not specified in this part. This information
is available in advisory documents (collectively referred to as
Pesticide Assessment Guidelines) through the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161
(telephone: 703-487-4650).
Sec. 158.25 Applicability of data requirements.
(a) Some kinds of data and information are specified in subparts C
and D of this part as ``required'' (``R'') for the evaluation of some or
all types of products. Other kinds of data and information are specified
in those sections as ``conditionally required'' (``CR''), that is, they
are required if the product's proposed pattern of use, results of other
tests, or other pertinent factors meet the criteria specified in those
sections. The terms ``required'' and ``conditionally required'' are
further discussed in Sec. Sec. 158.100 and 158.101.
(b) The Agency recognizes that certain data requirements may not be
applicable to (or should be waived for) some products, and has made
provisions for such cases in this part as specified in Sec. 158.35
Flexibility of the data requirements, Sec. 158.40 Consultation with the
Agency, Sec. 158.45 Waivers, and Sec. 158.60 Minor uses.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.30 Timing of the imposition of data requirements.
This part establishes requirements for the types of data which are
necessary to support the unconditional registration of a pesticide
product under section 3(c)(5) of the Act. While every registered
pesticide product must eventually be supported by the data required by
part 158, when an applicant or registrant must initially satisfy these
data requirements depends on the factors listed below in this section.
(a) Existing Registrations. A registrant of a currently registered
pesticide product is not obligated to satisfy any data requirement in
part 158 with respect to that product until he receives a notice under
section 3(c)(2)(B) of the Act that additional data are required to
support the continued registration of the product, until he applies for
an amendment to the registration, or until the product is subject to
reregistration.
(b) Applications. The amount of data required by the Agency to
evaluate an application for initial or amended registration depends on
whether the product is being reviewed under section 3(c)(5) of the Act
(unconditional registration) or section 3(c)(7) of the Act (conditional
registration). Refer to Sec. 152.111 of this chapter or consult with
the appropriate EPA Product Manager to determine under which section of
the Act the application will be reviewed. The following paragraphs
identify, for each different type of application, the minimum amount of
data that must be available for EPA review to permit EPA to make the
statutory risk-benefit determinations required by section 3(c)(5) or
3(c)(7) of the Act. In addition to satisfying these minimum data
requirements, applicants may be required to submit or cite additional
data, either to permit EPA to assess the safety or efficacy of the
product (refer to Sec. 158.75) or to comply with the statutory
requirements of section 3(c)(1)(D) of the Act, or both.
(1) Applications for unconditional registration under section
3(c)(5) of the Act. EPA will not approve an application for
unconditional registration unless all data required by this part which
[[Page 80]]
have not been waived are available for EPA to review.
(2) Applications for conditional registration of a new chemical
under section 3(c)(7)(C) of the Act. EPA will not approve an application
for conditional registration of a pesticide containing an active
ingredient not contained in any currently registered product unless data
required by this part are available for EPA to review except for:
(i) Those data for which the requirement has been waived.
(ii) Those data for which the requirement was imposed so recently
that the applicant has not had sufficient time to produce the data.
(3) Applications for conditional registration of products which are
identical or substantially similar to currently registered products
under section 3(c)(7)(A) of the Act. EPA will not approve an application
for conditional registration of a pecticide product which is identical
or substantially similar to a currently registered pesticide unless the
following data are available for EPA to review:
(i) Product chemistry data, as required by subpart C of this part.
(ii) Product performance data, to the extent required by Sec.
158.160.
(4) Applications for conditional registration of new uses of
currently registered products under section 3(c)(7)(B) of the Act. EPA
will not approve an application for registration of a pesticide for a
new use of a currently registered pesticide product unless the following
data are available for EPA to review:
(i) Product chemistry data, as required by subpart C of this part.
(ii) Product performance data, to the extent required by Sec.
158.160.
(iii) Other data pertaining solely to the new use. The applicant may
generally determine which data pertain solely to the new use by
comparing the data requirements for all existing uses of all currently
registered products containing the same active ingredient(s) with those
for all uses including the new use. Any differences are attributable to
the new use and must be submitted with the application.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58
FR 34203, June 23, 1993]
Sec. 158.32 Format of data submission.
(a) Transmittal document. All data submitted at the same time and
for review in support of a single administrative action (e.g., an
application for registration, reregistration, experimental use permit,
or in response to a requirement for data under the authority of FIFRA
sec. 3(c)(2)(B), must be accompanied by a single transmittal document
including the following information:
(1) The identity of the submitter, or the identity of each joint
submitter and of the agent for joint submitters;
(2) The date of the submission;
(3) The identification of the Agency action in support of which the
data are being submitted, such as the registration number or file
symbol, petition number, experimental use permit number, or registration
standard review; and
(4) A bibliography of all specific documents included in the
submission and covered by the transmittal.
(b) Individual studies. (1) All data must be submitted in the form
of individual studies. Unless otherwise specified by the Agency, each
study should address a single data requirement, and be listed separately
in the bibliography.
(2) Each study must include the following elements in addition to
the study itself:
(i) A title page, as described in paragraph (c) of this section;
(ii) A Statement of Data Confidentiality Claims and, if desired, a
Supplemental Statement of Data Confidentiality Claims, in accordance
with Sec. 158.33;
(iii) A certification with respect to Good Laboratory Practice
standards, if required by Sec. 160.12 of this chapter;
(iv) If the original study is not in the English language, a
complete and accurate English translation under the same cover; and
(v) If the study is of a type listed in Sec. 158.34(b), the
statement prescribed by paragraph (c) of that section.
(3) Three identical copies of each study must be submitted. If the
study is submitted in conjunction with a pending Special Review or
Registration Standard under development, four copies must be submitted.
Three copies
[[Page 81]]
must be identical and must conform to the requirements of Sec. 158.33
with respect to claims of confidentiality. The fourth copy will be
placed in the public docket and must conform to the requirements of
Sec. 154.15(c) of this chapter or Sec. 155.30(c) of this chapter with
respect to claimed confidential business information.
(4) All copies must be in black ink on uniform pages of white, 8\1/
2\ x 11 inch paper. Copies must have high contrast and good resolution
for microfilming. Frayed or oversize pages and glued bindings are not
acceptable.
(c) Contents of title page. Each individual study must have a title
page bearing the following identifying information:
(1) The title of the study, including identification of the
substance(s) tested and the test name or data requirement addressed;
(2) The author(s) of the study;
(3) The date the study was completed;
(4) If the study was performed in a laboratory, the name and address
of the laboratory and any laboratory project numbers or other
identifying codes;
(5) If the study is a commentary on or supplement to another
previously submitted study, full identification of the other study with
which it should be associated in review; and
(6) If the study is a reprint of a published document, all relevant
facts of publication, such as the journal title, volume, issue,
inclusive page numbers, and date of publication.
(d) EPA identification number. EPA will assign each study an EPA
Master Record Identification (MRID) number, and will promptly notify the
submitter of the number assigned. This number should be used in all
further communications with the Agency about the study.
(e) Reference to previously submitted data. Data which previously
have been submitted need not be resubmitted unless resubmission is
specifically requested by the Agency. If an applicant or registrant
wishes the Agency to consider such data in the review of an Agency
action, he should cite the data by providing:
(1) The title or adequate description of the study;
(2) The transmittal information required by paragraph (a) (1), (2),
and (3) of this section; and
(3) The MRID number assigned in accordance with paragraph (d) of
this section.
[53 FR 15991, May 4, 1988]
Sec. 158.33 Procedures for claims of confidentiality of data.
(a) General. A data submitter must clearly identify any information
which he claims is entitled to confidential treatment under FIFRA sec.
10. The procedures in this section must be followed to assert a claim of
confidentiality.
(b) Claims of confidentiality for information described by FIFRA
sec. 10(d)(1) (A), (B), and (C). Any information claimed to be
confidential under FIFRA sec. 10(d)(1) (A) through (C) must be submitted
in accordance with the following procedures:
(1) The information must be contained in a separate attachment to
the study. If any information is included in the body of the study
rather than in the confidential attachment, the submitter waives a claim
of confidentiality for such information under FIFRA sec. 10(d)(1) (A),
(B), or (C).
(2) The attachment must have a cover page which is clearly marked to
indicate that the material contained in the attachment falls within the
scope of FIFRA sec. 10(d)(1) (A), (B), or (C).
(3) Each item in the attachment must be numbered. For each item, the
submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A),
(B), or (C) on which the claim of confidentiality is based. In addition,
for each item, the submitter must provide a list of page numbers in the
study where the item is cited (i.e., identified by number).
(4) Each item in the attachment must be referenced in the body of
the study by its number in the attachment.
(5) The following statement must appear on the Statement of Data
Confidentiality Claims:
Information claimed confidential on the basis of its falling within
the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the
body of the study.
[[Page 82]]
The statement must bear the name, title, and signature of the submitter
or his properly designated agent, and the date of signature.
(c) No claim of confidentiality under FIFRA sec. 10(d)(1)(A), (B),
or (C). If no claim of confidentiality is being made for information
described by FIFRA sec. 10(d)(1)(A), (B), or (C), or if such information
is not contained in the body of the study, the Statement of Data
Confidentiality Claims must include the following statement:
No claim of confidentiality is made for any information contained in
this study on the basis of its falling within the scope of FIFRA sec.
10(d)(1)(A), (B), or (C).
This statement must bear the name, title and signature of the submitter
or his properly designated agent, and the date of signature.
(d) Claim of confidentiality for information not described by FIFRA
sec. 10(d)(1) (A), (B), or (C). Any information not described by FIFRA
sec. 10(d)(1) (A), (B), or (C) for which a claim of confidentiality is
made must be submitted in accordance with the following procedures:
(1) The information must be clearly marked in the body of the study
as being claimed confidential.
(2) A separate Supplemental Statement of Data Confidentiality Claims
must be submitted identifying by page and line number the location
within the study of each item claimed confidential, and stating the
basis for the claim.
(3) The Supplemental Statement of Data Confidentiality Claims must
bear the name, title, and signature of the submitter or his properly
designated agent, and the date of signature.
[53 FR 15991, May 4, 1988]
Sec. 158.34 Flagging of studies for potential adverse effects.
(a) Any person who submits a study of a type listed in paragraph (b)
of this section to support an application for new or amended
registration, or to satisfy a requirement imposed under FIFRA sec.
3(c)(2)(B), must submit with the study a statement in accordance with
paragraph (c) of this section.
(b) The following table indicates that study types and the criteria
to be applied to each. Column 1 lists the study types by name. Column 2
lists the associated Pesticide Assessment Guideline number. Column 3
lists the criteria applicable to each type of study. Column 4 lists the
reporting code to be included in the statement specified in Sec.
158.34(c) when any criterion is met or exceeded.
Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
Pesticide
assessment Reporting
Toxicity studies guidelines Criteria code
No.
----------------------------------------------------------------------------------------------------------------
Oncogenicity [or combined oncogenicity/ 83-2 Treated animals show any of the following: ...........
chronic feeding study]
or
Subchronic feeding study................. 82-1 An incidence of neoplasms in male or female 1
animals which increases with dose;
........... or
........... A statistically significant (p [lE]0.05) 2
incidence of any type of neoplasm in any
test group (male or female animals at any
dose level) compared to concurrent control
animals of the same sex;
........... or
........... An increase in any type of uncommon or rare 3
neoplasms in any test group (male or
female animals at any dose level) compared
to concurrent control animals
........... or
........... A decrease in the time to development of 4
any type of neoplasms in any test group
(male or female animals at any dose level)
compared to concurrent control animals
------------------------------------------
[[Page 83]]
Teratogenicity........................... 83-3 When compared with concurrent controls, 5
treated animals show a dose-related
increase in malformations (or deaths) on a
litter basis in the absence of significant
maternal toxicity at the same dose levels
------------------------------------------
Neurotoxicity............................ 81-7 When compared with controls, treated 6
animals show a response indicative of
acute delayed neurotoxicity
------------------------------------------
Chronic feeding study or combined chronic 83-1 Cholinesterase inhibition NOEL less than 10 7
feeding/oncogenicity study times the current existing ADI.
........... or
........... General (systemic) toxicity NOEL less than 8
100 times the current existing ADI.
------------------------------------------
Reproduction study....................... 83-4 Reproductive effects NOEL less than 100 9
times the current ADI.
------------------------------------------
Subchronic feeding study................. 82-1 Cholinesterase inhibition NOEL less than 10
100 times the current existing ADI.
........... or
........... General (systemic) toxicity NOEL less than 11
1000 times the current existing ADI.
----------------------------------------------------------------------------------------------------------------
(c) Identification of studies. For each study of a type identified
in paragraph (b) of this section, the applicant (or registrant in the
case of information submitted under FIFRA sec. 3(c)(2)(B)) shall include
the appropriate one of the following two statements, together with the
signature of the authorized representative of the company, and the date
of signature:
(1) ``I have applied the criteria of 40 CFR 158.34 for flagging
studies for potential adverse effects to the results of the attached
study. This study neither meets nor exceeds any of the applicable
criteria.''
(2) ``I have applied the criteria of 40 CFR 158.34 for flagging
studies for potential adverse effects to the results of the attached
study. This study meets or exceeds the criteria numbered [insert all
applicable reporting codes.]''
[53 FR 15992, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]
Sec. 158.35 Flexibility of the data requirements.
Several provisions of this part provide EPA flexibility in requiring
(or not requiring) data and information for the purposes specified in
Sec. 158.20(b). These provisions are summarized in this section and
discussed elsewhere in this part.
(a) The Agency encourages each applicant, particularly a person
applying for registration for the first time, to consult with the
Product Manager for his product to resolve questions relating to the
protocols or the data requirements before undertaking extensive testing
under Sec. 158.40.
(b) Any applicant who believes that a data requirement is
inapplicable to a specific pesticide product may request a waiver of a
data requirement under Sec. 158.45.
(c) The Agency may require an applicant to provide additional data
or information beyond that specified in subparts C and D of this part
when these data are not sufficient to permit EPA to evaluate the
applicant's product under Sec. 158.75.
(d) Several policies are in effect that govern the data requirements
for registration of products having minor uses. These policies reduce
substantially the data requirements that need to be met on the basis of
limited exposures and economic equity, and allow case-by-case decision
making to determine the specific needs for each kind of use under Sec.
158.60.
(e) The data requirements and guidelines are not static documents.
Section 3(c)(2) of FIFRA states that the administrator ``shall revise
such guidelines
[[Page 84]]
from time to time.'' Therefore, the data requirements and guidelines
will be revised periodically to reflect new scientific knowledge, new
trends in pesticide development, and new Agency policies under Sec.
158.80.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.40 Consultation with the Agency.
This part establishes data requirements applicable to various
general use patterns of pesticide products, but some unique or
unanticipated aspect of a proposed product's use pattern or composition
may result in the need for conferences between registration applicants
and the Agency. Such conferences may be initiated by the Agency or by
registration applicants. Applicants are expected to contact their
respective Product Managers to arrange discussions. The Agency welcomes
suggestions for changes to improve the clarity, accuracy, or some other
aspect of the data requirements set forth in this part. Specific
suggestions should be forwarded to the Director of the Hazard Evaluation
Division.
Sec. 158.45 Waivers.
(a) Rationale and policy. (1) The data requirements specified in
this part as applicable to a category of products will not always be
appropriate for every product in that category. Some products may have
unusual physical, chemical, or biological properties or atypical use
patterns which would make particular data requirements inappropriate,
either because it would not be possible to generate the required data or
because the data would not be useful in the Agency's evaluation of the
risks or benefits of the product. The Agency will waive data
requirements it finds are inappropriate, but will ensure that sufficient
data are available to make the determinations required by the applicable
statutory standards.
(2) The Agency will waive data requirements on a case-by-case basis
in response to specific written requests by applicants. Because of the
wide variety of types and use patterns of pesticides, it is impossible
to spell out all of the circumstances which might serve as a basis for
waiving data requirements. The Agency, however, will take into account,
as appropriate, the factors enumerated in sections 3(c)(2)(A) and
25(a)(1) of FIFRA.
(b) Procedure for requesting waiver. (1) An applicant should discuss
his plans to request a waiver with the EPA Product Manager responsible
for his product before developing and submitting extensive support
information for the request.
(2) To request a waiver, an applicant must submit a written request
to the appropriate Product Manager. The request must specifically
identify the data requirement for which a waiver is requested, explain
why he thinks data requirement(s) should be waived, describe any
unsuccessful attempts to generate the required data, furnish any other
information which he believes would support the request, and when
appropriate, suggest alternative means of obtaining data to address the
concern which underlies the data requirement.
(c) Notification of waiver decision. The Agency will review each
waiver request and inform the applicant in writing of its decision. In
addition, for decisions that could apply to more than a specific
product, the Agency may choose to send a notice to all registrants or to
publish a notice in the Federal Register announcing its decision. An
Agency decision denying a written request to waive a data requirement
shall constitute final Agency action for purposes of FIFRA section
16(a).
(d) Availability of waiver decisions. Agency decisions under this
section granting waiver requests will be available to the public at the
Office of Pesticide Programs Reading Room, Rm. 236, Crystal Mall
2, 1801 South Bell St., Arlington, VA 22202 from 8 a.m. to 4
p.m., Monday through Friday, except legal holidays. Any person may
obtain a copy of any waiver decision by written request in the manner
set forth in 40 CFR part 2.
[49 FR 42881, Oct. 24, 1984, as amended at 69 FR 39864, July 1, 2004]
Sec. 158.50 Formulators' exemption.
(a) FIFRA section 3(c)(2)(D) provides that an applicant for
registration of an end-use pesticide product need not submit or cite any
data that pertain to the
[[Page 85]]
safety of another registered pesticide product which is purchased by the
applicant and used in the manufacture or formulation of the product for
which registration is sought.
(b) This exemption applies only to data concerning safety of a
product or its ingredients, not to efficacy data. Data concerning safety
includes toxicity, metabolism, environmental fate, product chemistry,
and residue chemistry data.
(c) This exemption does not apply to data concerning the safety of
the applicant's end-use product itself, unless the composition of the
applicant's product and that of the purchased product are identical,
i.e., data which this part indicates must be developed by tests using
the end-use product for which registration is sought as the test
substance. These requirements can be identified by the notation ``EP*''
in the ``test substance'' column of the tables in subparts C and D of
this part and these are the minimum data requirements that the applicant
described in paragraph (a) of this section (i.e., the ``formulator'')
must satisfy.
(d) The data to which this exemption applies usually will concern
the safety of one or more of the end-use product's active ingredients,
specifically, those active ingredients which are contained in the
purchased product. These data requirements normally can be identified by
the notations ``TGAI'' (technical grade of active ingredient), ``PAI''
(pure active ingredients), ``PAIRA'' (pure active ingredient,
radiolabeled), or ``TEP'' (typical end-use product) in the ``test
substance'' column of the tables in subparts C and D of this part.
(e) EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant
to use the formulator's exemption with respect to a data requirement
concerning the safety of an ingredient of his product only if:
(1) His application indicates that the ingredient's presence in his
product is attributable solely to his purchase from another person of an
identified, registered product containing that ingredient and his use of
the purchased product in formulating his product; and
(2) The purchased product is a registered manufacturing-use product
whose label does not prohibit its use for making an end-use product with
any use for which the applicant's product will be labeled; or
(3) The purchased end-use product is a registered end-use product
labeled for each use for which the applicant's product will be labeled.
(f) Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve
an application unless there is available to EPA for its review whatever
data is necessary in order to make the required risk/benefit finding
under FIFRA section 3(c)(5) or section 3(c)(7).
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.55 Agricultural vs. non-agricultural pesticides.
Section 25(a)(1) of FIFRA instructs the Administrator to ``take into
account the difference in concept and usage between various classes of
pesticides and differences in environmental risk and the appropriate
data for evaluating such risk between agricultural and non-agricultural
pesticides.'' This part distinguishes the various classes of pesticide
use (e.g., crop vs. non-crop) and the corresponding data necessary to
support registration under FIFRA. This information is present in each
data requirement table. In addition, the Use Pattern Index (appendix A)
is a comprehensive list of pesticide use patterns, cross-referenced to
the general use patterns appearing in the tables; the index will further
assist the reader in distinguishing agricultural versus non-agricultural
uses of pesticides.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.60 Minor uses.
(a) Minor use policy. A minor use of a pesticide is a use on a
``minor crop'' (a crop which is planted on a small total amount of
acreage) or a use which is otherwise limited such that the potential
market volume of the product for that use is inherently small. EPA's
policy concerning data requirements for minor uses of pesticides
includes the following elements:
(1) Since the market volume for a minor use of a pesticide is
intrinsically
[[Page 86]]
low, and the risk associated with the use often is also correspondingly
low, EPA will adjust the data requirements concerning the minor use
appropriately.
(2) A new data requirement pertinent to both an unregistered minor
use and a registered major use will not be applied to a minor use
applicant until it is applied to the major use registrations.
(3) EPA will accept extrapolations and regional data to support
establishment of individual minor use tolerances.
(4) Group tolerances will be established to assist applicants for
registration of products for minor uses as described in 40 CFR 180.34.
(b) Advice on data requirements to support minor uses. Applicants
for registration are advised to contact the appropriate EPA Product
Manager of the Minor Use Officer for advice on developing data to
support new applications for minor uses of pesticides.
Sec. 158.65 Biochemical and microbial pesticides.
Biochemical and microbial pesticides are generally distinguished
from conventional chemical pesticides by their unique modes of action,
low use volume, target species specificity or natural occurrence. In
addition, microbial pesticides are living entities capable of survival,
growth reproduction and infection. Biochemical and microbial pesticides
are subject to a different set of data requirements, as specified in
Sec. Sec. 158.165 and 158.170, respectively.
(a) Biochemical pesticides. Biochemical pesticides include, but are
not limited to, products such as semichemicals (e.g. insect pheromones),
hormones (e.g., insect juvenile growth hormones), natural plant and
insect regulators, and enzymes. When necessary the Agency will evaluate
products on an individual basis to determine whether they are
biochemical or conventional chemical pesticides.
(b) Microbial pesticides. (1) Microbial pesticides include microbial
entities such as bacteria, fungi, viruses, and protozoans. The data
requirements apply to all microbial pesticides, including those that are
naturally-occurring as well as those that are genetically modified. Each
``new'' variety, subspecies, or strain of an already registered
microbial pest control agent must be evaluated, and may be subject to
additional data requirements.
(2) Novel microbial pesticides (i.e., genetically modified or non-
indigenous microbial pesticides) will be subject to additional data or
information requirements on a case-by-case basis depending on the
particular micro-organism, its parent microorganism, the proposed
pesticide use pattern, and the manner and extent to which the organism
has been genetically modified. Additional requirements may include
information on the genetic engineering techniques used, the identity of
the inserted or deleted gene segment (base sequence data or enzyme
restriction map of the gene), information on the control region of the
gene in question, a description of the ``new'' traits or characteristics
that are intended to be expressed, tests to evaluate genetic stability
and exchange, and/or selected Tier II environmental expression and
toxicology tests.
(3) Pest control organisms such as insect predators, nematodes, and
macroscopic parasites are exempt from the requirements of FIFRA as
authorized by section 25(b) of FIFRA and specified in Sec. 152.20 (a)
of this chapter.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.70 Acceptable protocols.
The Agency has published Pesticide Assessment Guidelines, as
indicated in Sec. 158.20(d), which contain suggested protocols for
conducting tests to develop the data required by this part.
(a) General policy. Any appropriate protocol may be used provided
that it meets the purpose of the test standards specified in the
guidelines and provides data of suitable quality and completeness as
typified by the protocols cited in the guidelines. Applicants should use
the test procedure which is most suitable for evaluation of the
particular ingredient, mixture, or product. Accordingly, failure to
follow a suggested protocol will not invalidate a test if another
appropriate methodology is used.
(b) Organization for Economic Cooperation and Development (OECD)
Protocols. Tests conducted in accordance with the
[[Page 87]]
requirements and recommendations of the applicable OECD protocols can be
used to develop data necessary to meet the requirements specified in
this part. Readers should note, however, that certain of the OECD
recommended test standards, such as test duration and selection of test
species, are less restrictive than those recommended by EPA. Therefore,
when using the OECD protocols, care should be taken to observe the test
standards in a manner such that the data generated by the study will
satisfy the requirements of this part.
(c) Procedures for requesting advice on protocols. Normally, all
contact between the Agency and applicants or registrants is handled by
the assigned Product Manager in the Registration Division of the Office
of Pesticide Programs. Accordingly, questions concerning protocols
should be directed, preferably in writing, to the Product Manager
responsible for the registration or application which would be affected.
Sec. 158.75 Requirements for additional data.
(a) General policy. The data routinely required by part 158 may not
be sufficient to permit EPA to evaluate every pesticide product. If the
information required under this part is not sufficient to evaluate the
potential of the product to cause unreasonable adverse effects on man or
the environment, additional data requirements will be imposed. However,
EPA expects that the information required by this part will be adequate
in most cases for an assessment of the properties of pesticide.
(b) Policy on test substance. In general, where the technical grade
of the active ingredient is specified as the substance to be tested,
tests may be performed using a technical grade which is substantially
similar to the technical grade used in the product for which
registration is sought. In addition to or in lieu of the testing
required in subparts C and D of this part the Administrator will, on a
case-by-case basis, require testing to be conducted with:
(1) An analytical pure grade of an active ingredient, with or
without radioactive tagging.
(2) The technical grade of an active ingredient.
(3) The representative technical grade of an active ingredient.
(4) An intentionally added inert ingredient in a pesticide product.
(5) A contaminant or impurity of an active or inert ingredient.
(6) A plant or animal metabolite or degradation product of an active
or inert ingredient.
(7) The end-use pesticide product.
(8) The end-use pesticide product plus any recommended vehicles and
adjuvants.
(9) Any additional substance which could act as a synergist to the
product for which registration is sought.
(10) Any combination of substances in paragraphs (b) (1) through (9)
of this section.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58
FR 34203, June 23, 1993]
Sec. 158.80 Acceptability of data.
(a) General policy. The Agency will determine whether the data
submitted to fulfill the data requirements specified in this part are
acceptable. This determination will be based on the design and conduct
of the experiment from which the data were derived, and an evaluation of
whether the data fulfill the purpose(s) of the data requirement. In
evaluating experimental design, the Agency will consider whether
generally accepted methods were used, sufficient numbers of measurements
were made to achieve statistical reliability, and sufficient controls
were built into all phases of the experiment. The Agency will evaluate
the conduct of each experiment in terms of whether the study was
conducted in conformance with the design, good laboratory practices were
observed, and results were reproducible. The Agency will not reject data
merely because they were derived from studies which, when initiated were
in accordance with an Agency-recommended protocol, even if the Agency
subsequently recommends a different protocol, as long as the data
fulfill the purposes of the requirements as described in this paragraph.
(b) Previously developed data. The Agency will consider that data
developed prior to the effective date of this
[[Page 88]]
part would be satisfactory to support applications provided good
laboratory practices were followed, the data meet the purposes of this
part, and the data permit sound scientific judgments to be made. Such
data will not be rejected merely because they were not developed in
accordance with suggested protocols.
(c) Data developed in foreign countries. The Agency considers all
applicable data developed from laboratory and field studies anywhere to
be suitable to support pesticide registrations except for data from
tests which involved field test sites or a test material, such as a
native soil, plant, or animal, that is not characteristic of the United
States. When studies at test sites or with materials of this type are
anticipated, applicants should take steps to assure that United States
materials are used or be prepared to supply data or information to
demonstrate the lack of substantial or relevant differences between the
selected material or test site and the United States material or test
site. Once comparability has been established, the Agency will assess
the acceptability of the data as described in paragraph (a) of this
section.
(d) Data from monitoring studies. Certain data are developed to meet
the monitoring requirements of FIFRA sections 5, 8 or 20. Applicants may
wish to determine whether some of these data may meet the requirements
of this part. In addition, data developed independently of FIFRA
regulations or requirements may also satisfy data requirements in this
part. Consultation with appropriate EPA Product Managers would be
helpful if applicants are unsure about suitability of such data.
Sec. 158.85 Revision of data requirements and guidelines.
(a) Data requirements will be revised from time to time to keep up
with policy changes and technology. Revisions to this part will be made
in accordance with the Administrative Procedure Act (5 U.S.C. 551 et
seq.). Changes having a significant impact on the registration process,
applicants, testers, or other parties, or on the outcome and evaluation
of studies, will be made only after public notice and opportunity for
comment. Until final rules reflecting a change have been promulgated,
the Agency can implement changes in the data requirements on a case-by-
case basis.
(b) The Agency invites registration applicants, registrants, and the
general public to suggest changes in the data requirements or the
Pesticide Assessment Guidelines. Suggestions may be submitted at any
time. Those making suggestions are requested to contact, in writing, the
Director of the Hazard Evaluation Division. When suggestions consist of
new suggested methods, representative test results should accompany the
submittals.
Subpart B_How To Use Data Tables
Sec. 158.100 How to determine registration data requirements.
To determine the specific kinds of data needed to support the
registration of each pesticide product, the registration applicant
should:
(a) Refer to subparts C and D (Sec. Sec. 158.150 through 158.740).
These subparts describe the data requirements, including data tables for
each subject area. The corresponding subdivisions in the Pesticide
Assessment Guidelines are listed in Sec. 158.108.
(b) Select the general use pattern(s) that best covers the use
pattern(s) specified on the pesticide product label. Selection of the
appropriate general use pattern(s) will usually be obvious. However,
unique or ambiguous cases will arise occasionally. These situations may
be clarified by reference to the Use Pattern Index presented in the
appendix to the Data Requirements for Registration. The applicant can
look up a specific use pattern in appendix A and it will be cross
referenced to the appropriate general use patterns to be used in each
Data Requirement table.
(c) Proceed down the appropriate general use pattern column in the
table and note which tests (listed along the left hand side of the
table) are required (``R''), conditionally required (``CR'') or usually
not required (``--''). After reading through each data requirement
table, the applicant will have a complete list of required and
conditionally required data for the pesticide product
[[Page 89]]
and the substance to be tested in developing data to meet each
requirement. The data EPA must have available to review the registration
of a specific product consists of all the data designated as required
for that product and all the applicable data designated as conditionally
required for that product.
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15993, May 4, 1988]
Sec. 158.101 Required vs. conditionally required data.
(a) Data designated as ``required'' (``R'') for products with a
given general use pattern are needed by EPA to evaluate the risks or
benefits of a product having that use pattern unless the data
requirement has been waived under Sec. 158.45 for that particular
product or unless the product is covered by a specific exception set
forth in a note accompanying the requirement.
(b) Data designated as ``conditionally required'' (``CR'') for
products with a given general use pattern are needed by EPA to evaluate
the risks or benefits of a product having that use pattern if the
product meets the conditions specified in the corresponding notes
accompanying the data requirements table. As indicated in the notes, the
determination of whether the data must be submitted is based on the
product's use pattern, physical or chemical properties, expected
exposure of nontarget organisms, and/or results of previous testing
(e.g., tier testing). Applicants must evaluate each applicable note to
determine whether or not conditionally required data must be submitted
as indicated by the conditions and criteria specified in the
accompanying notes unless the Agency has granted a waiver request
submitted by the registrant in accordance with Sec. 158.45.
(c) For certain of the required or conditionally required data, the
``R'' or ``CR'' designations and are enclosed in brackets (i.e., [R],
[CR]). The brackets designate those data that are required or
conditionally required to support a product when an experimental use
permit is being sought. In all other situations (i.e., other than
support of an experimental use permit), the brackets have no meaning and
the designations R and CR are equivalent to [R] and [CR], respectively.
[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]
Sec. 158.102 Distinguishing between what data are required and what
substance is to be tested.
(a) Readers should be careful to distinguish between what data are
required and what substance is to be tested, as specified in this part
and in each corresponding section of the guidelines. Each data
requirement table specifies whether a particular data requirement is
required to support the registration of manufacturing-use products, end-
use products, or both. The test substance column specifies which
substance is to be subjected to testing. Thus, the data from a certain
kind of study may be required to support the registration of each end-
use product, but the test substance column may state that the particular
test shall be performed using, for example, the technical grade of the
active ingredient(s) in the end-use product.
(b) Manufacturing-use products (MP) and end-use products (EP)
containing a single active ingredient and no inert ingredients are
identical in composition to each other and to the technical grade of the
active ingredient (TGAI) from which they were derived, and therefore,
the data from a test conducted using any one of these as the test
substance (e.g., TGAI) is also suitable to meet the requirement (if any)
for the same test to be conducted using either of the other substances
(i.e., MP or EP).
[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]
Sec. 158.108 Relationship of Pesticide Assessment Guidelines to data
requirements.
The Pesticide Assessment Guidelines contain the standards for
conducting acceptable tests, guidance on evaluation and reporting of
data, definition of terms, further guidance on when data are required,
and examples of acceptable protocols. They are available through the
National Technical Information Service, 5285 Port Royal Road,
Springfield, VA 22161 (703-487-4650). The following Subdivisions of the
Pesticide
[[Page 90]]
Assessment Guidelines, referenced to the appropriate sections of this
part, are currently available:
----------------------------------------------------------------------------------------------------------------
Corresponding
Subdivision Title NTIS order no. section(s) in this
part
----------------------------------------------------------------------------------------------------------------
D Product Chemistry................ PB83-153890 Sec. Sec. 158.150-
158.190
E Hazard Evaluation: Wildlife and PB83-153908 Sec. 158.490
Aquatic Organisms.
F Hazard Evaluation: Humans and PB83-153916 Sec. 158.340
Domestic Animals.
G Product Performance.............. PB83-153924 Sec. 158.640
I Experimental Use Permits......... PB83-153932 Sec. Sec. 158.20-
158.740
J Hazard Evaluation: Nontarget PB83-153940 Sec. 158.540
Plants.
K Reentry Protection............... PB85-120962 Sec. 158.390
L Hazard Evaluation: Nontarget PB83-153957 Sec. 158.590
Insect.
M Biorational Pesticides........... PB83-153965 Sec. Sec. 158.690-
158.740
N Environmental Fate............... PB83-153973 Sec. 158.290
O Residue Chemistry................ PB83-153961 Sec. 158.240
R Spray Drift Evaluation........... PB84-189216 Sec. 158.440
----------------------------------------------------------------------------------------------------------------
[53 FR 15993, May 4, 1988]
Subpart C_Product Chemistry Data Requirements
Source: 53 FR 15993, May 4, 1988, unless otherwise noted.
Sec. 158.150 General.
(a) Applicability. This subpart describes the product chemistry data
that are required to support the registration of each pesticide product.
The information specified in this subpart must be submitted with each
application for new or amended registration or for reregistration, if it
has not been submitted previously or if the previously submitted
information is not complete and accurate. References in this subpart to
the ``applicant'' include the registrant if the information is required
for a registered product.
(b) Purpose--(1) Product composition. (i) Data on product
composition are needed to support the conclusions expressed in the
statement of formula. These data include information on the starting
materials, production or formulating process, possible formation of
impurities, results of preliminary analysis of product samples, a
description of analytical methods to identify and quantify ingredients
and validation data for such methods. In addition, an applicant is
required to certify the limits for ingredients of his product.
(ii) Product composition data are compared to the composition of
materials used in required testing under subpart D of this part. This
comparison indicates which components of a pesticide product have been
evaluated by a particular study, and might lead to a conclusion that
another study is needed. Based on conclusions concerning the product's
composition and its toxic properties, appropriate use restrictions,
labeling requirements, or special packaging requirements may be imposed.
(iii) Product composition data, including certified limits of
components, are used to determine whether a product is ``identical or
substantially similar'' to another product or ``differs only in ways
that do not significantly increase the risk of unreasonable adverse
effects on the environment'' (FIFRA sec. 3(c)(7)(A)). In nearly every
case, this determination involves a comparison of the composition of an
applicant's product with that of currently registered products.
(2) Certified limits. Certified limits required by Sec. 158.175 are
used in two ways. First, the Agency considers the certified limits in
making the registration determination required by sections 3(c)(5),
3(c)(7) and 3(d) of the Act and making other regulatory decisions
required by the Act. Second, the Agency may collect commercial samples
of the registered products and analyze them for the active
ingredient(s), inert ingredients, or impurities determined by the Agency
to be toxicologically significant. If, upon analysis the composition of
such a sample is found to differ from that certified, the results may be
[[Page 91]]
used by the Agency in regulatory actions under FIFRA sec. 12(a)(1)(C)
and other pertinent sections.
(3) Nominal concentration. The nominal concentration required by
Sec. 158.155 is the amount of active ingredient that is most likely to
be present in the product when produced. Unlike the certified limits,
which are the outer limits of the range of the product's ingredients and
thus are present only in a small proportion of the products, the nominal
concentration is the amount that typically is expected to result from
the applicant's production or formulating process. The nominal
concentration together with production process information is used to
gauge the acceptability of the certified limits presented by the
applicant. The nominal concentration is used by the Agency as the basis
for enforceable certified limits if the applicant has chosen not to
specify certified limits of his own (thereby agreeing to abide by the
standard limits in Sec. 158.175).
(4) Physical and chemical characteristics. (i) Data on the physical
and chemical characteristics of pesticide active ingredients and
products are used to confirm or provide supportive information on their
identity. Such data are also used in reviewing the production or
formulating process used to produce the pesticide or product. For
example, data that indicate significant changes in production or
formulation might indicate the need for additional information on
product composition.
(ii) Certain information (e.g., color, odor, physical state) is
needed for the Agency to respond to emergency requests for
identification of unlabeled pesticides involved in accidents or spills.
Physicians, hospitals, and poison control centers also request this
information to aid in their identification of materials implicated in
poisoning episodes.
(iii) Certain physical and chemical data are used directly in the
hazard assessment. These include stability, oxidizing and reducing
action, flammability, explodability, storage stability, corrosion, and
dielectric breakdown voltage. For example, a study of the corrosion
characteristics of a pesticide is needed to evaluate effects of the
product formulation on its container. If the pesticide is highly
corrosive, measures can be taken to ensure that lids, liners, seams or
container sides will not be damaged and cause the contents to leak
during storage, transport, handling, or use. The storage stability study
provides data on change (or lack of change) in product composition over
time. If certain ingredients decompose, other new chemicals are formed
whose toxicity and other characteristics must be considered.
(iv) Certain data are needed as basic or supportive evidence in
initiating or evaluating other studies. For example, the octanol/water
partition coefficient is used as one of the criteria to determine
whether certain fish and wildlife toxicity or accumulation studies must
be conducted. Vapor pressure data are needed, among other things, to
determine suitable reentry intervals and other label cautions pertaining
to worker protection. Data on viscosity and miscibility provide
necessary information to support acceptable labeling for tank mix and
spray applications.
Sec. 158.153 Definitions.
The following terms are defined for the purposes of this subpart:
(a) Active ingredient means any substance (or group of structurally
similar substances, if specified by the Agency) that will prevent,
destroy, repel or mitigate any pest, or that functions as a plant
regulator, desiccant, or defoliant within the meaning of FIFRA sec.
2(a).
(b) End use product means a pesticide product whose labeling
(1) Includes directions for use of the product (as distributed or
sold, or after combination by the user with other substances) for
controlling pests or defoliating, desiccating or regulating growth of
plants, and
(2) Does not state that the product may be used to manufacture or
formulate other pesticide products.
(c) Formulation means
(1) The process of mixing, blending, or dilution of one or more
active ingredients with one or more other active or inert ingredients,
without an intended chemical reaction, to obtain a manufacturing use
product or an end use product, or
[[Page 92]]
(2) The repackaging of any registered product.
(d) Impurity means any substance (or group of structurally similar
substances if specified by the Agency) in a pesticide product other than
an active ingredient or an inert ingredient, including unreacted
starting materials, side reaction products, contaminants, and
degradation products.
(e) Impurity associated with an active ingredient means:
(1) Any impurity present in the technical grade of active
ingredient; and
(2) Any impurity which forms in the pesticide product through
reactions between the active ingredient and any other component of the
product or packaging of the product.
(f) Inert ingredient means any substance (or group of structurally
similar substances if designated by the Agency), other than an active
ingredient, which is intentionally included in a pesticide product.
(g) Integrated system means a process for producing a pesticide
product that:
(1) Contains any active ingredient derived from a source that is not
an EPA-registered product; or
(2) Contains any active ingredient that was produced or acquired in
a manner that does not permit its inspection by the Agency under FIFRA
sec. 9(a) prior to its use in the process.
(h) Manufacturing use product means any pesticide product other than
an end use product. A product may consist of the technical grade of
active ingredient only, or may contain inert ingredients, such as
stabilizers or solvents.
(i) Nominal concentration means the amount of an ingredient which is
expected to be present in a typical sample of a pesticide product at the
time the product is produced, expressed as a percentage by weight.
(j) Starting material means a substance used to synthesize or purify
a technical grade of active ingredient (or the practical equivalent of
the technical grade ingredient if the technical grade cannot be
isolated) by chemical reaction.
(k) Technical grade of active ingredient means a material containing
an active ingredient:
(1) Which contains no inert ingredient, other than one used for
purification of the active ingredient; and
(2) Which is produced on a commercial or pilot-plant production
scale (whether or not it is ever held for sale).
Sec. 158.155 Product composition.
Information on the composition of the pesticide product must be
furnished. The information required by paragraphs (a), (b) and (f) of
this section must be provided for each product. In addition, if the
product is produced by an integrated system, the information on
impurities required by paragraphs (c) and (d) must be provided.
(a) Active ingredient. The following information is required for
each active ingredient in the product:
(1) If the source of any active ingredient in the product is an EPA-
registered product:
(i) The chemical and common name (if any) of the active ingredient,
as listed on the source product.
(ii) The nominal concentration of the active ingredient in the
product, based upon the nominal concentration of active ingredient in
the source product.
(iii) Upper and lower certified limits of the active ingredient in
the product, in accordance with Sec. 158.175.
(2) If the source of any active ingredient in the product is not an
EPA-registered product:
(i) The chemical name according to Chemical Abstracts Society
nomenclature, the CAS Registry Number, and any common names.
(ii) The molecular, structural, and empirical formulae, and the
molecular weight or weight range.
(iii) The nominal concentration.
(iv) Upper and lower certified limits in accordance with Sec.
158.175.
(v) The purpose of the ingredient in the formulation.
(b) Inert ingredients. The following information is required for
each inert ingredient (if any) in the product:
(1) The chemical name of the ingredient according to Chemical
Abstracts Society nomenclature, the CAS Registry Number, and any common
names (if known). If the chemical identity or chemical composition of an
ingredient is not known to the applicant because
[[Page 93]]
it is proprietary or trade secret information, the applicant must ensure
that the supplier or producer of the ingredient submits to the Agency
(or has on file with the Agency) information on the identity or chemical
composition of the ingredient. Generally, it is not required that an
applicant know the identity of each ingredient in a mixture that he uses
in his product. However, in certain circumstances, the Agency may
require that the applicant know the identity of a specific ingredient in
such a mixture. If the Agency requires specific knowledge of an
ingredient, it will notify the applicant in writing.
(2) The nominal concentration in the product.
(3) Upper and lower certified limits in accordance with Sec.
158.175.
(4) The purpose of the ingredient in the formulation.
(c) Impurities of toxicological significance associated with the
active ingredient. For each impurity associated with the active
ingredient that is determined to be toxicologically significant, the
following information is required:
(1) Identification of the ingredient as an impurity.
(2) The chemical name of the impurity.
(3) The nominal concentration of the impurity in the product.
(4) A certified upper limit, in accordance with Sec. 158.175.
(d) Other impurities associated with the active ingredient. For each
other impurity associated with an active ingredient that was found to be
present in any sample at a level equal to or greater than 0.1 percent by
weight of the technical grade active ingredient, the following
information is required:
(1) Identification of the ingredient as an impurity.
(2) Chemical name of the impurity.
(3) The nominal concentration of the impurity in the final product.
(e) Impurities associated with an inert ingredient. [Reserved]
(f) Ingredients that cannot be characterized. If the identity of any
ingredient or impurity cannot be specified as a discrete chemical
substance (such as mixtures that cannot be characterized or isomer
mixtures), the applicant must provide sufficient information to enable
EPA to identify its source and qualitative composition.
Sec. 158.160 Description of materials used to produce the product.
The following information must be submitted on the materials used to
produce the product:
(a) Products not produced by an integrated system.
(1) For each active ingredient that is derived from an EPA-
registered product:
(i) The name of the EPA-registered product.
(ii) The EPA registration number of that product.
(2) For each inert ingredient:
(i) Each brand name, trade name, or other commercial designation of
the ingredient.
(ii) All information that the applicant knows (or that is reasonably
available to him) concerning the composition (and, if requested by the
Agency, chemical and physical properties) of the ingredient, including a
copy of technical specifications, data sheets, or other documents
describing the ingredient.
(iii) If requested by the Agency, the name and address of the
producer of the ingredient or, if that information is not known to the
applicant, the name and address of the supplier of the ingredient.
(b) Products produced by an integrated system. (1) The information
required by paragraph (a)(1) of this section concerning each active
ingredient that is derived from an EPA-registered product (if any).
(2) The following information concerning each active ingredient that
is not derived from an EPA-registered product:
(i) The name and address of the producer of the ingredient (if
different from the applicant).
(ii) Information on each starting material used to produce the
active ingredient, as follows:
(A) Each brand name, trade name, or other commercial designation of
the starting material.
(B) The name and address of the person who produces the starting
material or, if that information is not known to
[[Page 94]]
the applicant, the name and address of each person who supplies the
starting material.
(C) All information that the applicant knows (or that is reasonably
available to him) concerning the composition (and if requested by the
Agency, chemical or physical properties) of the starting material,
including a copy of all technical specifications, data sheets, or other
documents describing it.
(3) The information required by paragraph (a)(2) of this section
concerning each inert ingredient.
(c) Additional information. On a case-by-case basis, the Agency may
require additional information on substances used in the production of
the product.
Sec. 158.162 Description of production process.
If the product is produced by an integrated system, the applicant
must submit information on the production (reaction) processes used to
produce the active ingredients in the product. The applicant must also
submit information on the formulation process, in accordance with Sec.
158.165.
(a) Information must be submitted for the current production process
for each active ingredient that is not derived from an EPA-registered
product. If the production process is not continuous (a single reaction
process from starting materials to active ingredient), but is
accomplished in stages or by different producers, the information must
be provided for each such production process.
(b) The following information must be provided for each process
resulting in a separately isolated substance:
(1) the name and address of the producer who uses the process, if
not the same as the applicant.
(2) A general characterization of the process (e.g., whether it is a
batch or continuous process).
(3) A flow chart of the chemical equations of each intended reaction
occurring at each step of the process, the necessary reaction
conditions, and the duration of each step and of the entire process.
(4) The identity of the materials used to produce the product, their
relative amounts, and the order in which they are added.
(5) A description of the equipment used that may influence the
composition of the substance produced.
(6) A description of the conditions (e.g., temperature, pressure,
pH, humidity) that are controlled during each step of the process to
affect the composition of the substance produced, and the limits that
are maintained.
(7) A description of any purification procedures (including
procedures to recover or recycle starting materials, intermediates or
the substance produced).
(8) A description of the procedures used to assure consistent
composition of the substance produced, e.g., calibration of equipment,
sampling regimens, analytical methods, and other quality control
methods.
Sec. 158.165 Description of formulation process.
The applicant must provide information on the formulation process of
the product (unless the product consists solely of a technical grade of
active ingredient), as required by the following sections:
(a) Section 158.162(b)(2), pertaining to characterization of the
process.
(b) Section 158.162(b)(4), pertaining to ingredients used in the
process.
(c) Section 158.162(b)(5), pertaining to process equipment.
(d) Section 158.162(b)(6), pertaining to the conditions of the
process.
(e) Section 158.162(b)(8), pertaining to quality control measures.
Sec. 158.167 Discussion of formation of impurities.
The applicant must provide a discussion of the impurities that may
be present in the product, and why they may be present. The discussion
should be based on established chemical theory and on what the applicant
knows about the starting materials, technical grade of active
ingredient, inert ingredients, and production or formulation process. If
the applicant has reason to believe that an impurity that EPA would
consider toxicologically significant may be present, the discussion must
include an expanded discussion of the possible formation of the impurity
[[Page 95]]
and the amounts at which it might be present. The impurities which must
be discussed are the following, as applicable:
(a) Technical grade active ingredients and products produced by an
integrated system. (1) Each impurity associated with the active
ingredient which was found to be present in any analysis of the product
conducted by or for the applicant.
(2) Each other impurity which the applicant has reason to believe
may be present in his product at any time before use at a level equal to
or greater than 0.1 percent (1000 ppm) by weight of the technical grade
of the active ingredient, based on what he knows about the following:
(i) The composition (or composition range) of each starting material
used to produce his product.
(ii) The impurities which he knows are present (or believes are
likely to be present) in the starting materials, and the known or
presumed level (or range of levels) of those impurities.
(iii) The intended reactions and side reactions which may occur in
the production of the product, and the relative amounts of byproduct
impurities produced by such reactions.
(iv) The possible degradation of the ingredients in the product
after its production but prior to its use.
(v) Post-production reactions between the ingredients in the
product.
(vi) The possible migration of components of packaging materials
into the pesticide.
(vii) The possible carryover of contaminants from use of production
equipment previously used to produce other products or substances.
(viii) The process control, purification and quality control
measures used to produce the product.
(b) Products not produced by an integrated system. Each impurity
associated with the active ingredient which the applicant has reason to
believe may be present in the product at any time before use at a level
equal to or greater than 0.1 percent (1000 ppm) by weight of the product
based on what he knows about the following:
(1) The possible carryover of impurities present in any registered
product which serves as the source of any of the product's active
ingredients. The identity and level of impurities in the registered
source need not be discussed or quantified unless known to the
formulator.
(2) The possible carryover of impurities present in the inert
ingredients in the product.
(3) Possible reactions occurring during the formulation of the
product between any of its active ingredients, between the active
ingredients and inert ingredients, or between the active ingredients and
the production equipment.
(4) Post-production reactions between any of the product's active
ingredients and any other component of the product or its packaging.
(5) Possible migration of packaging materials into the product.
(6) Possible contaminants resulting from earlier use of equipment to
produce other products.
(c) Expanded discussion. On a case-by-case basis, the Agency may
require an expanded discussion of information of impurities:
(1) From other possible chemical reactions;
(2) Involving other ingredients; or
(3) At additional points in the production or formulation process.
Sec. 158.170 Preliminary analysis.
(a) If the product is produced by an integrated system, the
applicant must provide a preliminary analysis of each technical grade of
active ingredient contained in the product to identify all impurities
present at 0.1 percent or greater of the TGAI. The preliminary analysis
should be conducted at the point in the production process after which
no further chemical reactions designed to produce or purify the
substance are intended.
(b) Based on the preliminary analysis, a statement of the
composition of the technical grade of active ingredient must be
provided. If the technical grade of active ingredient cannot be
isolated, a statement of the composition of the practical equivalent of
the technical grade of active ingredient must be submitted.
[[Page 96]]
Sec. 158.175 Certified limits.
The applicant must propose certified limits for the ingredients in
the product. Certified limits become legally binding limits upon
approval of the application. Certified limits will apply to the product
from the date of production to date of use, unless the product label
bears a statement prohibiting use after a certain date, in which case
the certified limits will apply only until that date.
(a) Ingredients for which certified limits are required. Certified
limits are required on the following ingredients of a pesticide product:
(1) An upper and lower limit for each active ingredient.
(2) An upper and lower limit for each inert ingredient.
(3) If the product is a technical grade of active ingredient or is
produced by an integrated system, an upper limit for each impurity of
toxicological significance associated with the active ingredient and
found to be present in any sample of the product.
(4) On a case-by-case basis, certified limits for other ingredients
or impurities as specified by EPA.
(b) EPA determination of certified limits for active and inert
ingredients. (1) Unless the applicant proposes different limits as
provided in paragraph (c) of this section, the upper and lower certified
limits for active and inert ingredients will be determined by EPA. EPA
will calculate the certified limits on the basis of the nominal
concentration of the ingredient in the product, according to the table
in paragraph (b)(2) of this section.
(2) Table of standard certified limits.
------------------------------------------------------------------------
The certified limits for that
If the nominal concentration ingredient will be as follows:
(N) for the ingredient is: ----------------------------------------
Upper limit Lower limit
------------------------------------------------------------------------
N <= 1.0%...................... N + 10%N N - 10%N
1.0% < N <= 20.0%.............. N + 5%N N - 5%N
20.0% < N <= 100.0%............ N + 3%N N - 3%N
------------------------------------------------------------------------
(c) Applicant proposed limits. (1) The applicant may propose a
certified limit for an active or inert ingredient that differs from the
standard certified limit calculated according to paragraph (b)(2) of
this section.
(2) If certified limits are required for impurities, the applicant
must propose a certified limit. The standard certified limits may not be
used for such substances.
(3) Certified limits should:
(i) Be based on a consideration of the variability of the
concentration of the ingredient in the product when good manufacturing
practices and normal quality control procedures are used.
(ii) Allow for all sources of variability likely to be encountered
in the production process.
(iii) Take into account the stability of the ingredient in the
product and the possible formation of impurities between production and
sale of distribution.
(4) The applicant may include an explanation of the basis of his
proposed certified limits, including how the certified limits were
arrived at (e.g., sample analysis, quantitative estimate based on
production process), and its accuracy and precision. This will be
particularly useful if the range of the certified limit for an active or
inert ingredient is greater than the standard certified limits.
(d) Special cases. If the Agency finds unacceptable any certified
limit (either standard or applicant-proposed), the Agency will inform
the applicant of its determination and will provide supporting reasons.
EPA may also recommend alternative limits to the applicant. The Agency
may require, on a case-by-case basis, any or all of the following:
(1) More precise limits.
(2) More thorough explanation of how the certified limits were
determined.
(3) A narrower range between the upper and lower certified limits
than that proposed.
(e) Certification statement. The applicant must certify the accuracy
of the information presented, and that the certified limits of the
ingredients will be maintained. The following statement, signed by the
authorized representative of the company, is acceptable:
I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the
description of the composition of [product name], EPA Reg. No.
[[Page 97]]
[insert registration number], refers to the composition set forth on the
Statement of Formula and supporting materials. This description includes
the representations that: (1) no ingredient will be present in the
product in an amount greater than the upper certified limit or in an
amount less than the lower certified limit (if required) specified for
that ingredient in a currently approved Statement of Formula (or as
calculated by the Agency); and (2) if the Agency requires that the
source of supply of an ingredient be specified, that all quantities of
such ingredient will be obtained from the source specified in the
Statement of Formula.
Sec. 158.180 Enforcement analytical method.
An analytical method suitable for enforcement purposes must be
provided for each active ingredient in the product and for each other
ingredient or impurity that is determined to be toxicologically
significant.
Sec. 158.190 Physical and chemical characteristics.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the physical and chemical characteristics
data requirements and the substance to be tested.
----------------------------------------------------------------------------------------------------------------
All general use Test substance
patterns ---------------------------------------- Guidelines
Kind of data required (b) (requirements are reference
Notes the same for every Data to support MP Data to support EP No.
use pattern)
----------------------------------------------------------------------------------------------------------------
Color.......................... ....... [R]............... MP and TGAI....... EP* and TGAI...... 63-2
Physical state................. ....... [R]............... MP and TGAI....... EP* and TGAI...... 63-3
Odor........................... ....... [R]............... MP and TGAI....... EP* and TGAI...... 63-4
Melting point.................. (\1\) [R]............... TGAI.............. TGAI.............. 63-5
Boiling point.................. (\2\) [R]............... TGAI.............. TGAI.............. 63-6
Density, bulk density, or ....... [R]............... MP and TGAI....... EP* and TGAI...... 63-7
specific gravity.
Solubility..................... ....... [R]............... TGAI or PAI....... TGAI or PAI....... 63-8
Vapor pressure................. ....... [R]............... TGAI or PAI....... TGAI or PAI....... 63-9
Dissociation constant.......... ....... [R]............... TGAI or PAI....... TGAI or PAI....... 63-10
Octanol/water partition (\3\) [CR].............. PAI............... PAI............... 63-11
coefficient.
pH............................. (\4\) [CR].............. MP and TGAI....... EP* and TGAI...... 63-12
Stability...................... ....... [R]............... TGAI.............. TGAI.............. 63-13
Oxidizing or reducing action... (\5\) [CR].............. .................. .................. ..........
Flammability................... (\6\) [CR].............. MP................ EP*............... 63-15
Explodability.................. (\7\) [R]............... MP................ EP*............... 63-16
Storage stability.............. ....... [R]............... MP................ EP*............... 63-17
Viscosity...................... (\8\) [CR].............. MP................ EP*............... 63-18
Miscibility.................... (\9\) [CR].............. MP................ EP*............... 63-19
Corrosion characteristics...... ....... [R]............... MP................ EP*............... 63-20
Dielectric breakdown voltage... (\10\) [CR].............. .................. EP*............... 63-21
Other requirements: Submittal (\11\) [CR].............. MP, TGAI, PAI..... EP*, TGAI, PAI.... 64-1
of samples.
----------------------------------------------------------------------------------------------------------------
Key: R = Required; CR = Conditionally Required; [ ] = Brackets (i.e. [R],[CR]) indicate data requirements that
apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product;
asterisk indicates those registrants that end-use applicants (i.e. formulators) need not satisfy, if their
active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active
Ingredient; PAI = Pure Active Ingredient.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this
section.
(\1\) Required if technical chemical is a solid at room temperature.
(\2\) Required if technical chemical is a liquid at room temparature.
(\3\) Required if technical chemical is organic and non-polar.
(\4\) Required if test substance is dispersible with water.
(\5\) Required if product contains an oxidizing or reducing agent.
(\6\) Required if product contains combustible liquids.
(\7\) Required if product is potentially explosive.
(\8\) Required if product is a liquid.
(\9\) Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.
(\10\) Required if end-use product is a liquid and is to be used around electrical equipment.
(\11\) Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a
product produced by an integrated system when the new TGAI is first used as a formulating ingredient in
products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical
standard is also required at this time. Samples of end use products produced by an integrated system must be
submitted on a case-by-case basis.
[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]
[[Page 98]]
Subpart D_Data Requirement Tables
Sec. 158.202 Purposes of the registration data requirements.
(a) General. The data requirements for registration are intended to
generate data and information necessary to address concerns pertaining
to the identity, composition, potential adverse effects and
environmental fate of each pesticide.
(b) [Reserved]
(c) Residue chemistry. (1) Residue Chemistry Data are used by the
Agency to estimate the exposure of the general population to pesticide
residues in food and for setting and enforcing tolerances for pesticide
residues in food or feed.
(2) Information on the chemical identity and composition of the
pesticide product, the amounts, frequency and time of pesticide
application, and results of test on the amount of residues remaining on
or in the treated food or feed, are needed to support a finding as to
the magnitude and identity of residues which result in food or animal
feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy
of one or more methods for the enforcement of the tolerance, and to
support practicable methods for removing residues that exceed any
proposed tolerance.
(d) Environmental fate--(1) General. The data generated by
environmental fate studies are used to: assess the toxicity to man
through exposure of humans to pesticide residues remaining after
application, either upon reentering treated areas or from consuming
inadvertently-contaminated food; assess the presence of widely
distributed and persistent pesticides in the environment which may
result in loss of usable land, surface water, ground water, and wildlife
resources; and, assess the potential environmental exposure of other
nontarget organisms, such as fish and wildlife, to pesticides. Another
specific purpose of the environmental fate data requirements is to help
applicants and the Agency estimate expected environmental concentrations
of pesticides in specific habitats where threatened or endangered
species or other wildlife populations at risk are found.
(2) Degradation studies. The data from hydrolysis and photolysis
studies are used to determine the rate of pesticide degradation and to
identify pesticides that may adversely affect nontarget organisms.
(3) Metabolism studies. Data generated from aerobic and anaerobic
metabolism studies are used to determine the nature and availability of
pesticides to rotational crops and to aid in the evaluation of the
persistence of a pesticide.
(4) Mobility studies. These data requirements pertain to leaching,
adsorption/desorption, and volatility of pesticides. They provide
information on the mode of transport and eventual destination of the
pesticide in the environment. This information is used to assess
potential environmental hazards related to: contamination of human and
animal food; loss of usable land and water resources to man through
contamination of water (including ground water); and habitat loss of
wildlife resulting from pesticide residue movement or transport in the
environment.
(5) Dissipation studies. The data generated from dissipation studies
are used to assess potential environmental hazards (under actual field
use conditions) related to: reentry into treated areas; hazards from
residues in rotational crop and other food sources; and the loss of land
as well as surface and ground water resources.
(6) Accumulation studies. Accumulation studies indicate pesticide
residue levels in food supplies that originate from wild sources or from
rotational crops. Rotational crop studies are necessary to establish
realistic crop rotation restrictions and to determine if tolerances may
be needed for residues on rotational crops. Data from irrigated crop
studies are used to determine the amount of pesticide residues that
could be taken up by representative crops irrigated with water
containing pesticide residues. These studies allow the Agency to
establish label restrictions regarding application of pesticides on
sites where the residues can be taken up by irrigated crops. These data
also provide information that aids the Agency in establishing
[[Page 99]]
any corresponding tolerances that would be needed for residues on such
crops. Data from pesticides accumulation studies in fish are used to
establish label restrictions to prevent applications in certain sites so
that there will be minimal residues entering edible fish or shell fish.
These residue data are also used to determine if a tolerance or action
level is needed for residues in aquatic animals eaten by humans.
(e) Hazard to humans and domestic animals. Data required to assess
hazards to humans and domestic animals are derived from a variety of
acute, sub chronic and chronic toxicity tests, and tests to assess
mutagenicity and pesticide metabolism.
(1) Acute studies. Determination of acute oral, dermal and
inhalation toxicity is usually the initial step in the assessment and
evaluation of the toxic characteristics of a pesticide. These data
provide information on health hazards likely to arise soon after, and as
a result of, short-term exposure. Data from acute studies serve as a
basis for classification and precautionary labeling. For example, acute
toxicity data are used to calculate farmworker reentry intervals and to
develop precautionary label statements pertaining to protective clothing
requirements for applicators. They also: provide information used in
establishing the appropriate dose levels in subchronic and other
studies; provide initial information on the mode of toxic action(s) of a
substance; and determine the need for child resistant packaging.
Information derived from primary eye and primary dermal irritation
studies serves to identify possible hazards from exposure of the eyes,
associated mucous membranes and skin.
(2) Subchronic studies. Subchronic tests provide information on
health hazards that may arise from repeated exposures over a limited
period of time. They provide information on target organs and
accumulation potential. The resulting data are also useful in selecting
dose levels for chronic studies and for establishing safety criteria for
human exposure. These tests are not capable of detecting those effects
that have a long latency period for expression (e.g., carcinogenicity).
(3) Chronic studies. Chronic toxicity (usually conducted by feeding
the test substance to the test species) studies are intended to
determine the effects of a substance in a mammalian species following
prolonged and repeated exposure. Under the conditions of this test,
effects which have a long latency period or are cumulative should be
detected. The purpose of long-term oncogenicity studies is to observe
test animals over most of their life span for the development of
neoplastic lesions during or after exposure to various doses of a test
substance by an appropriate route of administration.
(4) Teratogenicity and reproduction studies. The teratogenicity
study is designed to determine the potential of the test substance to
induce structural and/or other abnormalities to the fetus as the result
of exposure of the mother during pregnancy. Two-generation reproduction
testing is designed to provide information concerning the general
effects of a test substance on gonadal function, estrus cycles, mating
behavior, conception, parturition, lactation, weaning, and the growth
and development of the offspring. The study may also provide information
about the effects of the test substance on neonatal morbidity,
mortality, and preliminary data on teratogenesis and serve as a guide
for subsequent tests.
(5) Mutagenicity studies. For each test substance a battery of tests
are required to assess potential to affect the mammalian cell's genetic
components. The objectives underlying the selection of a battery of
tests for mutagenicity assessment are:
(i) To detect, with sensitive assay methods, the capacity of a
chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to
mammals.
(iii) When mutagenic potential is demonstrated, to incorporate these
findings in the assessment of heritable effects, oncogenicity, and
possibly, other health effects.
(6) Metabolism studies. Data from studies on the absorption,
distribution, excretion, and metabolism of a pesticide aid in the
valuation of test results from other toxicity studies and in the
extrapolation of data from animals
[[Page 100]]
to man. The main purpose of metabolism studies is to produce data which
increase the Agency's understanding of the behavior of the chemical in
its consideration of the human exposure anticipated from intended uses
of the pesticide.
(f) Reentry Protection. Data required to assess hazard to farm
employees resulting from reentry into areas treated with pesticides are
derived from studies on toxicity, residue dissipation, and human
exposure. Monitoring data generated during exposure studies are used to
determine the quantity of pesticide to which people may be exposed after
application and to develop reentry intervals.
(g) Pesticide Spray Drift Evaluation. Data required to evaluate
pesticide spray drift are derived from studies of droplet size spectrum
and spray drift field evaluations. These data contribute to development
of the overall exposure estimate and along with data on toxicity for
humans, fish and wildlife, or plants are used to assess the potential
hazard of pesticides to these organisms. A purpose common to all these
tests is to provide data which will be used to determine the need for
(and appropriate wording for) precautionary labeling to minimize the
potential adverse effect to nontarget organisms.
(h) Hazard to nontarget organisms--(1) General. The information
required to assess hazards to nontarget organisms are derived from tests
to determine pesticidal effects on birds, mammals, fish, terrestrial and
aquatic invertebrates, and plants. These tests include short-term acute,
subacute, reproduction, simulated field, and full field studies arranged
in a hierarchial or tier system which progresses from the basic
laboratory tests to the applied field tests. The results of each tier of
tests must be evaluated to determine the potential of the pesticide to
cause adverse effects, and to determine whether further testing is
required. A purpose common to all data requirements is to provide data
which determines the need for (and appropriate wording for)
precautionary label statements to minimize the potential adverse effects
to nontarget organisms.
(2) Short term studies. The short-term acute and subchronic
laboratory studies provide basic toxicity information which serves as a
starting point for the hazard assessment. These data are used: to
establish acute toxicity levels of the active ingredient to the test
organisms; to compare toxicity information with measured or estimated
pesticide residues in the environment in order to assess potential
impacts on fish, wildlife and other nontarget organisms; and to indicate
whether further laboratory and/or field studies are needed.
(3) Long term and field studies. Additional studies (i.e., avian,
fish, and invertebrate reproduction, lifecycle studies and plant field
studies) may be required when basic data and environmental conditions
suggest possible problems. Data from these studies are used to: estimate
the potential for chronic effects, taking into account the measured or
estimated residues in the environment; and to determine if additional
field or laboratory data are necessary to further evaluate hazards.
Simulated field and/or field data are used to examine acute and chronic
adverse effects on captive or monitored fish and wildlife populations
under natural or near-natural environments. Such studies are required
only when predictions as to possible adverse effects in less extensive
studies cannot be made, or when the potential for adverse effects is
high.
(i) Product performance. Requirements to develop data on product
performance provide a mechanism to ensure that pesticide products will
control the pests listed on the label and that unnecessary pesticide
exposure to the environment will not occur as a result of the use of
ineffective products. Specific performance standards are used to
validate the efficacy data in the public health areas, including
disinfectants used to control microorganisms infectious to man in any
area of the inanimate environment and those pesticides used to control
vertebrates (such as rodents, birds, bats and skunks) that may directly
or indirectly transmit diseases to humans.
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
May 4, 1988]
[[Page 101]]
Sec. 158.240 Residue chemistry data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the residue chemistry data requirements
and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food corp Nonfood Food corp Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity............. (1) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 171-2
Directions for use............ (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] ................ ................ 171-3
Nature of the residue:
Plants.................... (13), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] PAIRA........... PAIRA........... 171-4
(14)
Livestock................. (3), [CR] .......... [CR] .......... [CR] ......... ......... [CR] [CR] PAIRA and plant PAIRA and plant 171-4
(13), metabloites. metabolites.
(14)
Residue analytical method..... (4), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] TGAI and TGAI and 171-4
(13), metabolites. metabolites.
(14),
(15)
Magnitude of the residue:
Crop field trials......... (13), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] TEP............. TEP............. 171-4
(14)
Processed food/feed....... (5), (14) [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] EP.............. EP.............. 171-4
Meat/milk/poultry/eggs.... (6), (14) [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] TGAI or plant TGAI or plant 171-4
metabolites. metabolites.
Potable water............. (7) .......... .......... [R] [R] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Fish...................... (8) .......... .......... [R] [R] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Irrigated crops........... (9) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Food handling............. (10), .......... .......... .......... .......... ......... ......... ......... ......... [CR] EP.............. EP.............. 171-4
(14)
Reduction of residue.......... (11), [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] Residue of Residue of 171-5
(14) concern. concern.
Proposed tolerance............ (12), [R] .......... [R] .......... [R] ......... ......... ......... [CR] Residue of Residue of 171-6
(14) concern. concern.
Reasonable grounds in support (14) [R] .......... [R] .......... [R] ......... ......... ......... [CR] ................ ................ 171-7
of the petition.
Submittal of analytical (14) [R] .......... [R] .......... [R] ......... ......... ......... [CR] PAIRA........... PAIRA........... 171-13
reference standards.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required data; CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; EP=End-use product; TEP=Typical end-use
product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The same chemical identity data as required under subpart C of this part are required, with emphasis on impurities that could constitute a residue problem.
(2) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(3) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(4) A residue method for enforcement of tolerances is needed whenever a numeric tolerance is proposed. Exemptions from the requirement of a tolerance will also usually require an analytical
method. Analytical methods used to enforce residue limits for emergency exemptions, temporary tolerances and permanent tolerances must be available for use by enforcement agencies and thus
may not be claimed as confidential business information.
(5) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
tolerance.
[[Page 102]]
(6) Livestock feeding studies are required whenever a pesticide occurs as a residue in a livestock feed. Use involving direct application to livestock, including poultry, will require animal
treatment residue studies.
(7) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
for drinking purpose, by man or animals.
(8) Data on residue in fish are required whenever a pesticide is to be applied directly to water inhabited by fish.
(9) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
ditches.
(10) Data on residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments. Disinfectants and sanitizers used in
food or feed handling establishment are exempt from this requirement if their residues are regulated by the Food and Drug Administration at 21 CFR 178.1010.
(11) Reduction of residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level. Data on the level of residue in food as
consumed will be used to obtain a more precise estimate of potential dietary exposure. The Agency recommends that such data be generated to support all pesticides requiring a tolerance in
case new data are revealed which indicates the pesticide is more toxic than initially determined.
(12) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry eggs.
(13) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerance was
established.
(14) Required to support registration of an indoor use pesticide if such a use could result in residues in food or feed.
(15) For all food uses, data on whether the FDA/USDA multiresidue methodology would detect and identify the pesticide are required.
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
15999, May 4, 1988; 58 FR 34203, June 23, 1993]
Sec. 158.290 Environmental fate data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the environmental fate data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation studies-lab
Hydrolysis.................... ......... [R] [R] [R] [R] [R] [R] [R] [R] ......... TGAI or PAIRA... TGAI or PAIRA... 161-1
Photodegradation:
In water.................. ......... R R R R ......... ......... R ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-2
On soil................... (1) CR .......... .......... .......... ......... ......... CR ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-3
In air.................... (2) CR .......... .......... .......... ......... ......... ......... ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-4
Metabolism studies-lab
Aerobic soil.............. ......... [R] [R] .......... .......... R R [R] R ......... TGAI or PAIRA... TGAI or PAIRA... 162-1
Anaerobic aquatic......... ......... .......... .......... R R ......... ......... R ......... ......... TGAI or PAIRA... TGAI or PAIRA... 162-3
Aerobic aquatic........... ......... .......... .......... [R] [R] ......... ......... ......... ......... ......... TGAI or PAIRA... TGAI or PAIRA... 162-4
[[Page 103]]
Mobility studies
Leaching and adsorption/ ......... [R] [R] R R R R [R] R ......... TGAI or PAIRA... TGAI or PAIRA... 163-1
desorption.
Volatility:
(Lab)..................... (2) CR .......... .......... .......... CR CR ......... ......... ......... TEP............. TEP............. 163-2
(Field)................... (2) CR .......... .......... .......... CR CR ......... ......... ......... TEP............. TEP............. 163-3
Dissipation studies-field
Soil.......................... ......... R R .......... .......... ......... ......... ......... R ......... TEP............. TEP............. 164-1
Aquatic (sediment)............ ......... .......... .......... R R ......... ......... ......... ......... ......... TEP............. TEP............. 164-2
Forestry...................... ......... .......... .......... .......... .......... ......... ......... R ......... ......... TEP............. TEP............. 164-3
Combination and tank mixes.... (2) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 164-4
Soil, long-term............... (4) CR .......... CR .......... ......... ......... ......... ......... ......... TEP............. TEP............. 164-5
Accumulation studies
Rotational crops:
(Confined)................ (5) [CR] .......... [CR] .......... ......... ......... ......... ......... ......... PAIRA........... PAIRA........... 165-1
(Field)................... (6) CR .......... CR .......... ......... ......... ......... ......... ......... TEP............. TEP............. 165-2
Irrigated crops............... (7) .......... .......... [CR] CR ......... ......... ......... ......... ......... TEP............. TEP............. 165-3
In fish....................... (8) [CR] [CR] [CR] [CR] ......... ......... [CR] ......... ......... TGAI or PAIRA... TGAI or PAIRA... 165-4
In aquatic non-target (8), (9) .......... .......... .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 165-5
organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required: CR=Conditionally required; [ ]=Brackets (ie. [R], [CR], indicate data requirements that apply when an experimental use permit is being sought; TGAI=Technical grade of the
active ingredient, PAIRA=``Pure'' active ingredient-radio labeled; TEP=typical end use product; EP =End use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if use involves application to soils solely by injection of the product into the soil or by incorporation of the product into the soil upon application.
AAA(2) Required on case by case basis depending on product use pattern and other pertinent factors.
AAA(3) Not required if anaerobic aquatic metabolism study has been conducted.
AAA(4) Required if pesticide residues do not readily dissipate in soil.
AAA(5) Confined accumulation study is required when it is reasonably foreseeable that any food or feed crop may be subsequently planted on the site of pesticide application.
AAA(6) Field accumulation study is required if significant pesticide residue is likely to be present in soil at time of plant crop, as evidenced by residue data obtained from confined
accumulation study.
AAA(7) Required if it is reasonably foreseeable that water at treated site may be used for irrigation purposes.
AAA(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
organisms.
AAA(9) Required unless tolerance or action level for fish has been granted.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988]
Sec. 158.340 Toxicology data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the toxicology data requirements and the
substance to be tested.
[[Page 104]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Acute testing
Acute oral toxicity--rat...... (1) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 81-1
dilution* and
TGAI.
Acute dermal toxicity......... (1), (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 81-2
dilution* and
TGAI.
Acute inhalation toxicity--rat (16) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 81-3
Primary eye irritation--rabbit (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-4
Primary dermal irritation..... (1), (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-5
Dermal sensitization.......... (3) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-6
Acute delayed neurotoxicity-- (4) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 81-7
hen.
Subchronic testing
90-day feeding studies--rodent (17) [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 82-1
and nonrodent.
21-day dermal................. (18) CR CR CR CR CR CR CR CR CR TGAI............ TGAI and EP*.... 82-2
90-day dermal................. (5), (19) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-3
90-day inhalation--rat (6) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-4
90-day neurotoxicity:
Hen......................... (7) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-5
Mammal...................... (8) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-5
Chronic testing
Chronic feeding--2 spp. rodent (9), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-1
and nonrodent. (13),
(20)
Oncogenicity study--2 Spp. rat (9), (21) R CR R CR R CR CR CR CR TGAI............ TGAI............ 83-2
and mouse preferred.
Teratogenicity--2 species..... (10), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-3
(15)
Reproduction, 2-generation.... (11), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-4
(14)
Mutagenicity testing
Gene mutation................. (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-2
Structural chromosomal (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-2
aberration.
Other genotoxic effects....... (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-4
[[Page 105]]
Special testing
General metabolism............ (23) R CR R CR R CR CR CR CR PAI or PAIRA.... PAI or PAIRA.... 85-1
Dermal penetration............ (24) CR CR CR CR CR CR CR CR CR Choice.......... Choice.......... 85-2
Domestic animal safety........ (12) CR CR CR CR ......... ......... CR CR ......... Choice.......... Choice.......... 86-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AAAKey: R=Required data; CR=Conditionally required; [ ]=Brackets (ie [R], [CR] indicate data requirements that apply when an experimental use permit is being sought; MP=manufacturing-use
product; EP*=End-Use Product; (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must satisfy, provided that their active ingredient(s) is (are)
purchased from a registered source); TGAI=Technical grade of the active ingredient; PAI=``Pure'' active ingredient; PAIRA=``Pure'' active ingredient, radio-labeled; Choice=choice of several
test substances, depending on studies required.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if test material is a gas or highly volatile.
(2) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as toxicity category I on the basis of potential eye and
dermal irritation effects.
(3) Required unless repeated dermal exposure does not occur under conditions of use.
(4) Not required unless test material, is an organophosphate, or a metabolite or degradation product thereof which causes acetyl cholinesterase depression or is structurally related to a
substance that causes delayed neurotoxicity.
(5) Required if use involves purposeful dermal application to, or prolonged exposure of, human skin.
(6) Required if use may result in repeated inhalation exposure at a concentration likely to be toxic. A test with duration of 21 days is required if pesticide is used on tobacco.
(7) Required if acute delayed neurotoxicity test showed neuropathy or neurotoxicity or if closely related structural to a compound which can induce these effects.
(8) Required if acute oral, dermal, or inhalation studies showed neuropathy or neurotoxicity.
(9)(i) Studies designed to simultaneously meet the requirements of both the chronic feeding and oncogenicity studies (i.e., a combined study) can be conducted.
(ii) Minimum acceptable test durations for chronic feeding and oncogenicity studies are as follows:
(A) Chronic rodent feeding study (food use pesticides)--24 months.
(B) Chronic rodent feeding study (non-food pesticides)--12 months is usually sufficient.
(C) Chronic nonrodent (i.e., dog) feeding study--12 months.
(D) Mouse oncogenicity study--18 months.
(E) Rat oncogenicity study--24 months.
(10) Required to support products intended for food uses and to supoort products intended for non-food uses if significant exposure of human females of child bearing age may reasonably be
expected.
(11) Required to support products intended for food uses and to support products intended for non-food uses if use of the product is likely to result in human exposure over a portion of the
human lifespan which is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for example; pesticides used in treated fabrics for wearing
apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives; constant-release indoor pesticides which are used in aerosol form).
(12) Required on a case by case basis.
(13) In most cases, where theoretical maximum residue contribution (TMRC) exceeds 50 percent of the maximum permitted intake (MPI), a one year (or longer) interim report on a chronic feed
study is required to support a temporary tolerance.
(14) In most cases, where theoretical maxium residue contribution (TMRC) exceeds 50 percent of the maxium permitted intake (MPI), a first generation (or longer) interim report on a
multigeneration reproduction study is required to support a temporary tolerance.
(15) A teratology study in one species is required to support a temporary tolerance.
(16) Required if the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas volatile substances, or aerosol/particulate).
(17) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via the oral route.
(ii) Expected human exposure is over a limited portion of the human lifespan, yet is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for
example, products requiring a temporary tolerance to support an experimental use permit or emergency exemption).
(18) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via skin contact.
(ii) Expected human skin contact is not purposeful, and such exposure is of limited frequence and duration (for example, such exposure could result from use of certain disinfectant, liquid
fumigant or agricultural or home/garden pesticide products, and other circumstances where the Agency determines that more than acute dermal exposure is involved).
(iii) Data from a subchronic 90-day dermal toxicity study are not required.
(19) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable human exposure to the product, (e.g., swimming pool algaecides, pesticides
for impregnating clothing), and if either of the following criteria are met:
(i) Data from a subchronic oral study are not required.
(ii) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient
is the toxic moiety.
(20) Required if either of the following criteria are met:
(i) Use of the pesticide product is likely to result in repeated human exposure to the product, over a significant portion of the human life-span (for example, products intended for use in and
around residences, swimming pools, and enclosed working spaces or their immediate vicinity).
[[Page 106]]
(ii) The use requires a tolerance for the pesticide or an exemption from the requirement to obtain a tolerance, or requires issuance of a food additive regulation.
(21) Required if any of the following criteria are met:
(i) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities:
(A) Is structually related to a recognized carcinogen.
(B) Is a substance that cause mutagenic effect as demonstrated by in vitro or in vivo testing.
(C) Produces in subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia) in any organ that may lead to neoplastic change.
(ii) The use requires a tolerance for the pesticide or exemption from the requirement to obtain a tolerance, or requires the issuance of a food additive regulation.
(iii) Use of the pesticide product is likely to result in human exposure over a portion of the human lifespan which is significant in terms of either the time the exposure occurs or the
duration of exposure (for example; pesticides used in treated fabrics for wearing apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives;
constant-release indoor pesticides which are used in aerosol form).
(22)(i) The required battery of mutagenicity tests must include tests appropriate to address the following three categories in accordance with the objectives set forth in Sec. 158.202:
(A) Gene mutations.
(B) Structural chromosomal aberrations.
(C) Other genotoxic effects as appropriate for the test substance, e.g., numerical chromosome abberations, direct DNA damage and repair, mammalian cells transformation, target organ/cell
analysis.
(ii) Currently recognized tests for each of these categories are listed with the National Technical Information Service (NTIS). Applicants shall explain their reasons for selecting specific
tests from the battery of currently recognized tests. Because of the rapid improvements in this field, applicants are encouraged to discuss with the Agency: test selection, protocol design
and results of preliminary testing.
(iii) Not required if the pesticide use pattern precludes human exposure (e.g., nonvolatile pesticides packaged and used in enclosed bait boxes).
(23) Required if chronic feeding or oncogenicity studies are required.
(24) Dermal absorption studies required for compounds having a serious toxic effect as identified by oral or inhalation studies, for which a significant route of human exposure is dermal and
for which the assumption of 100 percent absorption does not produce an adequate margin of safety. Registrants should work closely with the Agency in developing an acceptable protocol and
performing dermal absorption studies.
[[Page 107]]
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
15999, May 4, 1988; 58 FR 34203, June 23, 1993]
[[Page 108]]
Sec. 158.390 Reentry protection data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the reentry protection data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
-------------------------------------------------------------------------------------------------------------------------------------------- Guideline
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
----------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foliar dissipation............ (1) CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 132-1
Soil dissipation.............. (1), (4) CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 132-1
Dermal exposure............... (1), (2), CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 133-3
(3)
Inhalation exposure........... (1), (2), CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 133-4
(3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required if the following conditions are met:
(i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or
(B) The acute inhalation toxicity of the technical grade of active ingredient is less than 200 mg/m \3\ (for a one-hour exposure); or
(C) The acute oral toxicity of the technical grade of active ingredient is less than 50 mg/kg (body weight); or
(D) Neurotoxic, teratogenic, or oncogenic effects or other adverse effects as evidenced by subchronic, chronic, and reproduction studies would be expected from entry of persons into treated
sites; or
(E) The Agency receives other scientifically validated toxicological or epidemiological evidence that a pesticide or residue of a pesticide could cause adverse effects on persons entering
treated sites. In the last situation, reentry intervals and supporting data may be required on a case-by-case basis.
(ii) And if: end-use product is to be registered for:
(A) Application to growing crops, such as to or around horticultural and agronomic crops that are field- or orchard-grown.
(B) Application to outdoor tree nursery and forestry operations.
(C) Application to turf crops and commercial applications to turf.
(D) Application to parks and arboretums; or (E) application to aquatic crops.
(iii) And if: human exposure to residues of the pesticide can be reasonably foreseen. This applies primarily to pesticides that will be used on crops where human tasks will involve substantial
exposure to residues of the pesticide.
(2) Data required if appropriate surrogate data are not available.
(3) Data required if the applicant chooses to use the allowable exposure level method for proposal of a reentry interval.
(4) Soil dissipation data required if agricultural practice involves human tasks that would cause substantial exposure to residues sorbed to soil.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.440 Spray drift data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the aerial spray drift data requirements
and the substance to be tested.
[[Page 109]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Droplet size spectrum......... (1) CR CR CR CR ......... ......... CR ......... ......... TEP............. TEP............. 201-1
Drift field evaluation........ (1) CR CR CR CR ......... ......... CR ......... ......... TEP............. TEP............. 202-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end use product.
(b) Notes. The following are referenced in column two of the table contained in paragraph (a) of this section.
(1) This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental
effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This
requirement may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
(2) [Reserved]
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.490 Wildlife and aquatic organisms data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the wildlife and aquatic organisms data
requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food Crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and mammalian testing
Avian oral LD50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-1
mallard or bobwhite).
Avian dietary LC50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-2
mallard and bobwhite).
Wild mammal toxicity.......... (2) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-3
Avian reproduction (preferably (3) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-4
mallard and bobwhite).
Simulated and actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 71-5
testing--mammals and birds.
[[Page 110]]
Aquatic organism testing
Freshwater fish LC50 (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-1
(preferably rainbow and
bluegill).
Acute LC50 freshwater (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-2
invertebrates (preferably
Daphnia).
Acute LC50 estuarine and (4), (7) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-3
marine organisms.
Fish early life stage and (5) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-4
aquatic invertebrate life-
cycle.
Fish--life-cycle.............. (6) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-5
Aquatic organism accumulation. (8) CR CR CR CR ......... ......... CR CR ......... TGAI, PAI, or TGAI, PAI, or 72-6
degradation degradation
product. product.
Simulated or actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP TEP 72-7
testing--aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditonally required; [ ]=Brackets (ie. [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought; TGAI=Techical grade of the active
ingredient; TEP=Typical end-use product; PAI=``Pure'' active ingredient.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1)(i) Data are required as follows to support manufacturing use products and those end-use products for indoor use for which there is no registered manufacturing use product:
(A) Solid formulation indoor use products require avian oral LD50 (bobwhite), avian dietary LC50 (bobwhite), freshwater fish LC50 (rainbow trout) and acute LC50 freshwater invertebrate
(Daphnia).
(B) Liquid formulation indoors use products require all tests listed under (b)(1)(i) of this section except the avian oral LD50.
(ii) Data are not required to support:
(A) Indoor end-use products consisting of a gas/highly volatile liquid or a highly reactive solid.
(B) Indoor end-use products for which there is a manufacturing use product registration.
(2) Tests required on a case-by-case basis depending on the results of lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate
characteristics.
(3) Data required if one or more of the following criteria are met:
(i) Birds may be subjected to repeated or continued exposure to the pesticide or any of its major metabolite degradation products, especially preceding or during the breeding season.
(ii) The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in avian feed.
(iii) The pesticide or any of its major metalolites or degradation products is stored or accumulated in plant animal tissues, as indicated by its octanol/water partition coefficient,
accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
(iv) Any other information, such as that derived from mammalian reproduction studies that indicates the reproduction in terrestrial vertebrates may be adversely affected by the anticipated use
of the pesticide product.
Note: Prior to conducting this test to support the registration of an avicide, the applicant should consult the Agency.
(4) Data required if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations
because of its expected use or mobility pattern.
(5) Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever species is most sensitive to the pesticide as determined from the results of the acute
toxicity tests) are required if the product is applied directly to water or expected to be transported to water from the intended use site, and when any one or more of the following
conditions apply:
[[Page 111]]
(i) If the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity.
(ii) If any LC 50 or EC 50 value determined in acute toxicity testing is less than 1 mg/l; or
(iii) If the estimated environmental concentration in water is equal to or greater than 0.01 of any EC 50 or LC 50 determined in acute toxicity testing.
(iv) If the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any EC50 or LC50 determined in acute toxicity testing and any of the following
conditions exist:
(A) Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
(B) Physiochemical properties indicate cumulative effects.
(C) The pesticide is persistent in water (e.g., half-life in water greater than 4 days).
(6) Data are required if end-use product is intended to be applied directly to water or expected to transport to water from the intended use site, and when any of the following conditions
apply:
(i) if the estimated environmental concentration is equal to or greater than one-tenth of the no-effect level in the fish early life-stage or invertebrate life-cycle test.
(ii) If studies of other organisms indicate the reproductive physiology of fish may be affected. NOTE: The applicant should consult the Agency prior to these tests to support the registration
of a pesticide.
(7) Data from testing with the applicant's end-use product or a typical end-use product is required to support the registration of each end-use product which meets any one of the following
conditions:
(i) The end-use pesticide will be introduced directly not an aquatic environment when used as directed.
(ii) The LC50 or EC50 of the technical grade of active ingredient is equal to or less than the maximum expected environmental concentration (MEEC) or the estimated environmental concentration
(EEC) in the aquatic environment when the end-use pesticide is used as directed.
(iii) An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
organisms.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.540 Plant protection data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the plant protection data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Target area phytotoxicity..... (1) .......... .......... .......... .......... ......... ......... ......... ......... ......... EP.............. EP.............. 121-1
Nontarget area phytotoxicity..
Tier I:
Seed germination/seedling (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-1
emergence.
Vegetative vigor.......... (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-1
Aquatic plant growth...... (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-2
Tier II:
Seed germination/seedling (3) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-1
emergence.
Vegetative vigor.......... (3) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-1
Aquatic plant growth...... (4) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-2
Tier III:
Terrestrial field......... (3) .......... CR .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 124-1
[[Page 112]]
Aquatic field............. (4) .......... CR .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 124-2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TGAI=Technical grade of the active ingredient; EP=End-use product; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required for Special Review and certain public health situations.
(2) Data are required for pesticides to be used in forests and natural grasslands. For herbicide used in forest site preparation; the acquatic plant growth tests will be required. Data are
required to support products to be used in other locations when any of the following conditions are met:
(i) Phytotoxicity problems concerning the product arise and open literature data are not available to address the problems.
(ii) The product may pose hazards to endangered or threatened species.
(iii) Special Review has been initiated on the product.
(3) Required if a 25 percent or greater detrimental effect was found in 1 or more plant species in the corresponding test of the previous tier.
(4) Required if a 50 percent or greater detrimental effect was found on any plant species in the corresponding test of the previous tier.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.590 Nontarget insect data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the nontarget insect data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use pattern Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget insect testing--
pollinators
Honey bee acute contact LD50.. (1) [CR] [CR] [CR] [CR] ......... ......... [CR] [CR] ......... TGAI............ TGAI............ 141-1
Honey bee--toxicity of (1), (2) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 141-2
residues on foliage.
Honey bee subacute feeding (3) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 141-4
study.
Field testing for pollinators. (4) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 141-5
Nontarget insect testing--
aquatic insects
Acute toxicity to aquatic (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-1
insects.
Aquatic insect life-cycle (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-1
study.
[[Page 113]]
Simulated or actual field (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-3
testing for aquatic insects.
Nontarget insect testing-- (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 143-1
predators and parasites. thru
143-3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; [ ]=Brackets (ie, [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; TGAI=Technical grade of the
active ingredient; TEP=Typical end-use product.
(b) Notes. The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Required only if proposed use will result in honey bee exposure.
(2) Required only when formulation contains one or more active ingredients having an acute LD50 of less than 1 microgram/bee.
(3) This requirement is reserved pending development of test methodology.
(4) May be required under the following conditions:
(i) Data from the honey bee subacute feeding study indicate adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.).
(ii) Data from residual toxicity studies indicate extended residual toxicity.
(iii) Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute toxicity, such as the ability to cause reproductive or chronic effects.
(5) This requirement is reserved pending further evaluation to determine what and when data should be required, and to develop appropriate test methods.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.640 Product performance data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how
to use this table to determine the product performance data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial
agents
Products for use on hard (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-2
surfaces.
Products requiring (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-3
confirmatory data.
Products for use on fabrics (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-4
and textiles.
Air sanitizers................ (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-5
Products for control of (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-7
microbial pests associated
with human and animal wastes.
Products for treating water (1) .......... .......... [CR] .......... ......... ......... ......... ......... CR ................ EP*............. 91-8
systems.
[[Page 114]]
Efficacy of fungicides and
nematicides
Products for control of (1) [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... ................ EP*............. 93-16
organisms producing
mycotoxins.
Efficacy of Vertebrate Control
Agents
Avian toxicants............... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-5
Avian repellents.............. (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-6
Avian frightening agents...... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-7
Bat toxicants and repellents.. (1) .......... .......... .......... .......... ......... ......... ......... ......... (R)...... ................ EP*............. 96-9
Commensal rodenticides........ (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... TEP............. EP*............. 96-10
Rodenticides on farm and (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-12
rangelands.
Rodent fumigants.............. (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-13
Rodent reproductive inhibitors (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-16
Mammalian predacides.......... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-17
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; EP=End-use
product* (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must satisfy, provided that their active ingredient(s) is (are) purchased from a
registered source); MP=Manufacturing use product; TEP=Typical end-use product.
(b) Notes: The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose
presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates
(such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are
efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of
efficacy data for any pesticide product registered or proposed for registration.
(2) [Reserved]
[49 FR 42881, Oct. 24, 1984, as amended at 50 FR 46766, Nov. 13, 1985.
Redesignated at 53 FR 15993, May 4, 1988, and amended at 58 FR 34203,
June 23, 1993]
Sec. 158.690 Biochemical pesticides data requirements.
(a) Biochemical pesticide product analysis data requirements--(1)
Table. Sections 158.50 and 158.100 through 158.102 describe how to use
this table to determine the biochemical pesticides--product analysis
data requirements and the substance to be tested.
[[Page 115]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 151-10
Manufacturing process......... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-11
Discussion of formation of (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-12
unintentional ingredients.
Analysis of samples........... (iii) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI..... EP* and TGAI.... 151-13
Certification of limits....... ......... [R] R [R] R [R] R R R R MP.............. EP*............. 151-15
Analytical methods............ ......... R R R R R R R R R MP.............. EP*............. 151-16
Physical and chemical ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-17
properties.
Submittal of samples.......... (iv) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI, PAI EP*, TGAI and 151-18
PAI.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required CR=Conditionally required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes.The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under full scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
case-by-case basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.
(b) Biochemical pesticides residue data requirements. (1) Table.
Sections 158.50 and 158.100 though 158.102 describe how to use this
table to determine the biochemical pesticides--residue data requirements
and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity............. (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 153-3
(ii),
(xiv)
Directions for use............ (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] ................ ................ 153-3
(iii),
(xiv)
Nature of the residue:
Plants.................... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA........... PAIRA........... 153-3
(xiv)
Livestock................. (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA and plant PAIRA and plant 153-3
(iv), metabo- lites. metabo- lites.
(xiv)
[[Page 116]]
Residue analytical method..... (i), (v), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TGAI and metabo- TGAI and metabo- 153-3
(xiv) lites. lites.
Magnitude of the residue:
Crop field trials......... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TEP............. TEP............. 153-3
(xiv)
Processed food/feed....... (i), (vi) [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... EP.............. EP.............. 153-3
Meat/mild/poultry/eggs.... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] TGAI or plant TGAI or plant 153-3
(vii) metabo- lites. metabo- lites.
Potable water............. (i), .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
(viii)
Fish...................... (i), (ix) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Irrigated crops........... (i), (x) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Food handling............. (i), (xi) .......... .......... .......... .......... ......... ......... ......... ......... [CR] EP.............. EP.............. 153-3
Reduction of residue.......... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xii) concern. concern.
Proposed tolerance............ (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xiii) concern. concern.
Reasonable grounds in support ......... [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... ................ ................ 153-3
of the petition.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; TEP=typical end-use product, MP=Manufacturing-use product; [
]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue chemistry data requirements shall apply to biochemical pesticide products when any one or more of the following conditions apply:
(A) Tier II or III toxicology data are required, as specified for biochemical agents in (c)(1) of this section.
(B) The application rate of the product exceeds 0.7 ounces (20 grams) active ingredient per acre per application.
(C) The application rate of the product exceeds a level determined to be comparable to 0.7 ounces active ingredient per application but the application rate is not expressable in terms of
ounces per acre per application.
(ii) The same chemical identity data as required in (a)(1) of this section are required, with emphasis on impurities that could constitute a residue problem.
(iii) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(iv) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(v) A residue method suitable for enforcement of tolerances is needed whenever a numeric tolerance is proposed Exemptions from the requirement of a tolerance will also usually require an
analytical method.
(vi) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
tolerance.
(vii) Livestock feeding studies are required whenever a pesticide occurs as a residue in an livestock feed. Direct application to livestock uses will require animal treatment residue studies.
(viii) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
for drinking purpose, by man or animals.
(ix) Data on residues in fish are required whenever a pesticide is to be applied directly to water.
(x) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
ditches.
(xi) Data or residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments.
(xii) Reduction of residue data are required when the assumption of tolerance level residues results in an unsafe level of exposure. Data on the level of residue in food as consumed will be
used to obtain a more precise estimate of potential dietary exposure.
(xiii) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry/eggs.
(xiv) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerances were
established.
[[Page 117]]
(c) Biochemical pesticides toxicology data requirements--(1) Table.
Sections 158.50 and 158.100 through 158.102 describe how to use this
table to determine the biochemical pesticides--toxicology data
requirements and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Acute oral toxicity....... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-10
dilution* and
TGAI.
Acute dermal toxicity..... (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-11
dilution* and
TGAI.
Acute inhalation.......... (xiv) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 152-12
Primary eye irritation.... (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-13
Primary dermal irritation. (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-14
Hypersensitivity study.... (iii) CR CR CR CR CR CR CR CR CR MP.............. EP.............. 152-15
Hypersensitivity incidents (iv) CR CR CR CR CR CR CR CR CR ................ ................ 152-16
Studies to detect (v) [R] [CR] [R] [CR] [R] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 152-17
genotoxicity.
Immune response........... ......... [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-18
90-day feeding (1 spp.)... (vi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-20
90-day dermal (1 spp.).... (vii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-21
90-day inhalation (1 spp.) (viii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-22
Teratogenicity (1 spp.)... (ix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-23
Tier II:
Mammalian mutagenicity (x) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-19
tests.
Immune response........... (xi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-24
Tier III:
Chronic exposure.......... (xii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-26
Oncogenicity.............. (xiii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-29
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally Required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]] indicate data
requirement that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Not required if test material is a gas or is highly volatile.
[[Page 118]]
(ii) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified toxicity category I on the basis of potential eye and
dermal irritation effects.
(iii) Required if repeated contact with human skin results under condition of use.
(iv) Incidents must be reported, if they occur.
(v) Required to support non-food uses if use is likely to result in significant human exposure; or the active ingredient or its metabolites is (are) structurally related to a known mutagen, or
belongs(s) to any chemical class of compounds containing known mutagens.
(vi) Required if the use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires a food additive regulation; or the use of the product is otherwise
likely to result in repeated human exposure by the oral route.
(vii) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable prolonged human exposure to the product, (e.g., swimming pool algaecides,
pesticides for impregnating clothing), and if either of the following criteria are met:
(A) Data from a subchronic oral study are not required.
(B) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is
the toxic moiety.
(viii) Required if pesticidal use may result in repeated inhalation exposure at a concentration which is likely to be toxic.
(ix) Required if any of the following criteria are met:
(A) Use of the product under widespread and recognized practice may reasonably be expected to result in significant exposure to female humans.
(B) Its use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires issuance of a food additive regulation.
(x) Required if results from any one of the Tier I mutagenicity tests were positive.
(xi) Required if adverse effects are observed in the Tier I immune response studies.
(xii) Required if the potential for adverse chronic effects are indicated based on:
(A) The subchronic effect levels established in the Tier I subchronic oral toxicity studies, the Tier I subchronic dermal toxicity studies or the Tier I subchronic inhalation toxicity studies.
(B) The pesticide use pattern (e.g., rate, frequency, and site of application).
(C) The frequency and level of repeated human exposure that is expected.
(xiii) Required if the product meets either of the following criteria:
(A) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia)
in any organ that potentially could lead to neoplastic change.
(B) If adverse cellular effects suggesting oncogenic potential are observed in Tier I or Tier II immune response studies or in Tier II mammalian mutagenicity assays.
(xiv) Required if the product consists of, or under conditions of use results in, an inhalable material (e.g., gas, volatile substance, or aerosol/particulate).
(d) Nontarget organism, fate and expression data requirements--(1)
Table. Sections 158.50 and 158.100 through 158.102 describe how to use
this table to determine the biochemical pesticides non-target organism,
fate and expression data requirements and substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Avian acute oral.......... (i), (ii) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-6
Avian dietary............. (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-7
(ii),
(vi)
Freshwater fish LC50...... (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-8
(ii), (v)
Freshwater invertebrate (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-9
LC50. (ii),
(vii)
Nontarget plant studies... (iii) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 154-10
Nontarget insect testing.. (iv), (v) CR CR CR CR CR CR CR CR ......... TGAI............ TGAI............ 154-11
Tier II:
Volatility................ (viii) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 155-4
Dispenser-water leaching.. (ix) CR CR CR CR ......... ......... CR CR ......... EP.............. EP.............. 155-5
[[Page 119]]
Adsorption-desorption..... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-6
Octanol/Water Partition... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-7
U.V. absorption........... (xi) CR CR CR CR ......... ......... CR CR ......... PAI............. PAI............. 155-8
Hydrolysis................ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-9
Aerobic soil metabolism... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-10
Aerobic aquatic metabolism (x) CR CR CR CR ......... CR CR ......... TGAI............ TGAI............ 155-11
Soil photolysis........... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-12
Aquatic photolysis........ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-13
Tier III:
Terrestrial wildlife (xii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 15-12
testing.
Aquatic animal testing.... (xiii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-13
Nontarget plant studies... (xiv) .......... .......... .......... .......... ......... ......... ......... ......... ......... TGAI............ TGAI............ 154-14
Nontarget insect testing.. (xv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-15
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally reguired; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
MP=Manufacturing-use product; TEP=Typical end-Use product; TGAI=Technical grade of the active ingredient; EP=End-use product, PAI=``Pure'' active ingredient.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies: rainbow trout for freshwater fish studies; and Daphnia for freshwater invertebrate
studies on biochemicals.
(iii) Data are required for pesticides to be used in forests and natural grasslands. For herbicides used in forest site preparation; the aquatic plant growth tests will be required. Data are
required when to support products to be used in other locations when any of the following conditions are met.
(A) Phytotoxicity problems arise and open literature data are not available.
(B) The product may pose hazards to endangered or threatened species.
(C) A rebuttable presumption against registration Special Review has been initiated on the product.
(iv) Required depending on pesticide mode of action and results of any available product performance data.
(v) Biochemicals introduced directly into an aquatic environment when used as directed shall be tested as specified in Sec. 158.145.
(vi) Not required if pesticide is highly volatile (estimated volatility greater than 5x10-5 atm. m3/mol).
(vii) If the pesticide will be introduced directly into an aquatic environment when used as directed, then it must be tested as indicated in Sec. 158.145.
(viii) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land.
(ix) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land in a passive
dispenser.
(x) Required on a case-by-case basis when results of Tier I tests indicate environmental fate data are needed.
(xi) Required when results of Tier I tests indicate potential adverse effects on beneficial insects and the intended route of exposure of the pesticide is through vapor phase contact.
(xii) Required if either of the following criteria are met:
(A) Environmental fate characteristics indicate that the estimated concentration of the biochemical pesticide in the terrestrial environment is equal to or greater than \1/5\ the avian dietary
LC50 or the avian single dose oral LD50 (converted to ppm).
(B) The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian feed.
(xiii) Required if environmental fate characteristics indicate that the estimated environmental concentration of the biochemical agent in the aquatic environment is equal to or greater than
0.01 of any EC50 or LC50 determined in testing required by Tier I aquatic tests.
(xiv) Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement will be determined by the Tier II environmental fate
tests.
(xv) Required when results of Tier I tests indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
[[Page 120]]
Sec. 158.740 Microbial pesticides--Product analysis data requirements.
(a) Microbial pesticides product analysis data requirements--(1)
Table. Sections 158.50 and 158.100 through 158.102 describe how to use
this table to determine the microbial pesticides--product analysis data
requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity manufacturing ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 151-20
process.
(i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-21
Discussion of formation of (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-22
unintentional ingredients.
Analysis of samples........... (iii) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI..... EP* and TGAI.... 151-23
Certification of limits....... ......... [R] R [R] R [R] R R R R MP.............. EP*............. 151-25
Analytical methods............ ......... R R R R R R R R R MP.............. EP*............. 151-25
Physical and chemical ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-26
properties.
Submittal of samples.......... (iv) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI, PAI EP* TGAI and PAI 151-27
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product: EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
case-by-case basis. For pesticide in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
AAA(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.
(b) Microbial pesticides-residue data requirements--(1) Table.
Sections 158.50 and 158.100 through 158.102 describe how to use this
table to determine the microbial pesticides-residue data requirements
and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Residue data.................. (i) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] ................ ................ 153-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; EP=End-use product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being
sought.
[[Page 121]]
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue data requirements shall apply to microbial pesticides when Tier II or Tier III toxicology data are required, as specified for microbial pesticides in (c)(1) of this section.
(ii) [Reserved)
(c) Microbial pesticides-toxicology data requirements--(1) Table.
Sections 158.50 and 158.100 through 158.102 describe how to use this
table to determine the microbial pesticides-toxicology data requirements
and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Acute oral................ ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP* 152-30
dilution and
TGAI.
Acute dermal.............. ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-31
dilution and
TGAI.
Acute inhalation.......... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-32
Dilution* and
TGAI.
I.V., I.C., I.P. injection (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 152-33
Primary dermal............ ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 152-34
Primary eye............... ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 152-35
Hypersensitivity study.... (iii) R R R R R R R R R MP.............. EP*............. 152-36
Hypersensitivity incidents (iv) CR CR CR CR CR CR CR CR CR ................ ................ 152-37
Immune response........... ......... [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-38
Tissue culture............ (v) [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-39
Tier II:
Acute oral................ (vi) CR CR CR CR CR CR CR CR CR MP.............. EP*............. 152-40
Acute inhalation.......... (vii) CR CR CR CR CR CR CR CR CR MP.............. EP*............. 152-41
Subchronic oral........... (viii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-42
Acute I.P., I.C........... (ix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-43
Primary dermal............ (x) CR CR CR CR CR CR CR CR CR ................ EP*............. 152-44
Primary eye............... (xi) CR CR CR CR CR CR CR CR CR ................ EP*............. 152-45
Immune response........... (xii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-46
Teratogenicity............ (xiii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-47
Virulence enhancement..... (xiv) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-48
Mammalian mutagenicity.... (xv) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-49
Tier III:
Chronic feeding........... (xvi) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-50
Oncogenicity.............. (xvii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 151-51
Mutagenicity.............. (xviii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-52
[[Page 122]]
Teratogenicity............ (xix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-53
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product; EP*=End use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Required if 20 percent or more of the aerodynamic equivalent of the product (as registered or under conditions of use) is composed of particulates less than 10 microns in diameter.
(ii) Data required for products as follows:
(A) Intravenous (``IV'') infectivity study for bacterial, and viral agents;
(B) Intracerebral (``IC'') infectivity study for viral and protozoan agents; and
(C) Intraperitoneal (``IP'') infectivity study for fungal and protozoan agents.
(iii) Required if commonly recognized use practices will result in repeated human contact by inhalation or dermal routes.
(iv) Hypersensitivity incidents must be reported, if they occur.
(v) Data required for products whose active ingredient is a virus.
(vi) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the Tier I acute oral
infectivity tests or the intraperitoneal or intracerebral injection test for protozoa.
(vii) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the comparable Tier I acute
inhalation tests.
(viii) Required if there is evidence of survival, replication, infectivity, or persistence of the protozoan agent in the Tier I oral infectivity test.
(ix) Required if in Tier I acute oral infectivity testing, Tier I dermal toxicity/infectivity testing, or Tier I intraperitoneal or intracerebral injection testing, the test microorganism
(bacteria, fungi, or protozoa) survived for more than 2 weeks, caused toxic effects, or caused a severe illness response in an experimental animal as evidenced by irreversible gross
pathology, severe weight loss, toxemia, or death.
(x) Required if infectivity or if marked edema or broad erythema was observed in the Tier I dermal irritation study.
(xi) Required if infectivity or if severe ocular lesions are observed in the Tier I primary eye irritation study.
(xii) Required if results of the Tier I immune response test indicate abnormalities.
(xiii) Required when Tier I tests on viral agents show replication of the virus in mammalian hosts and significant damage to mammalian cells.
(xiv) Required when Tier I infectivity tests on bacteria or fungi indicate prolonged survival (including presence of viable microbial agents in test animal excreta) and/or multiplication
(infectivity) of the bacteria or fungal agent, respectively.
(xv) Required if any of the following criteria are met:
(A) Acute infectivity tests are positive in Tier I studies.
(B) Adverse effects are observed in immune response studies.
(C) Positive results are obtained in tissue culture tests with viral agents.
(xvi) Required when the potential for chronic adverse effects (e.g., replication or persistence of viral or subviral constituents, protozoans, fungi, or bacteria) are demonstrated by any of
the Tier II tests (except primary dermal, primary ocular, and mammalian mutagenicity tests).
(xvii) Required when the potential for oncogenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, or
bacteria, fungi or protozoans; or mutagenic effects) by any of the Tier II tests except the primary dermal and primary ocular studies.
(xviii) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, bacteria,
fungi or protozoa) by any of the Tier II tests except primary dermal or primary ocular studies.
(xix) Required when the potential for teratogenic effects is expected based on the presence of persistence of fungi, bacteria, viruses, or protozoa in mammalian species as a result of testing
performed in Tier II, except primary dermal and primary ocular studies.
(d) Microbial pesticides non-target organism and environmental
expression data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the
microbial pesticides non-target organism and environmental expression
data requirements and substances to be tested.
[[Page 123]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Avian oral................ (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-16
(ii),
(iii)
Avian injection test...... (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-17
(ii),
(iii)
Wild mammal testing....... (iv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-18
Freshwater fish testing... (i) [R] [R] [R] [R] CR CR [R] CR CR TGAI............ TGAI............ 154-19
Freshwater aquatic (i) [R] [R] [R] [R] CR CR [R] CR CR TGAI............ TGAI............ 154-20
invertebrate testing.
Estuarine and marine (v) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-2
animal testing.
Nontarget plant studies... ......... [R] [R] [R] [R] ......... ......... [R] [R] CR TEP............. TEP............. 154-2
Nontarget insect testing.. ......... [R] [R] [R] [R] CR CR [R] [R] ......... TGAI............ TGAI............ 154-23
Honey bee testing......... ......... [R] [R] [R] [R] CR CR [R] [R] ......... TGAI............ TGAI............ 154-24
Tier II:
Terrestrial environmental (vi) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-18
testing.
Freshwater environmental (vii) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-19
expression tests.
Marine or estuarine (xiii), CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-20
environmental expression (ix)
tests.
Tier III:
Terrestrial wildlife and (x) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 154-25
aquatic organism testing.
Avian pathogenicity/ (xi) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-26
reproduction test.
Definitive aquatic animal (xii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-27
tests.
Aquatic embryo larvae and (xiii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-28
life cycle studies.
Aquatic ecosystem test.... (xiv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-29
Special aquatic tests ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-30
(reserved).
Nontarget plant studies... (xv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TEP............. 154-31
[[Page 124]]
Tier IV: (xvi)
Simulated and actual field (xiii) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 154-33
tests (birds, mammals).
Simulated and actual field (xvii), CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 154-34
tests (aquatic organisms). (xviii)
Simulated and actual field ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-35
tests (insect predators,
parasites) (reserved).
Simulated and actual field ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-36
tests (insect
pollinators) (reserved).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AAAKey: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
MP=Manufacturing-use Product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; EP=End-use product; PAI=``Pure'' active ingredient.
AAA(2) Notes. The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
AAA(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
AAA(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies; rainbow trout for freshwater fish studies.
AAA(iii) Data from either the avian acute oral or the avian injection study are required to support an experimental use permit.
AAA(iv) Required on a case-by-case basis if results of tests required by paragraph (c)(1) of this section are inadequate or inappropriate for assessment of hazards to wild animals.
AAA(v) Required when product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of
expected use or mobility pattern.
AAA(vi) Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
AAA(A) Avian single dose oral toxicity and pathogenicity tests.
AAA(B) Avian injection pathogenicity tests.
AAA(C) Wild mammals toxicity and pathogenicity test.
AAA(D) Plant studies--terrestrial.
AAA(E) Honey bee toxicity/pathogenicity test.
AAA(F) Testing for toxicity/pathogenicity to insect predators and parasites.
AAA(vii) Required when toxic or pathogenic effects are observed in any of the following Tier I test for microbial pest control agents:
AAA(A) Freshwater fish toxicity and pathogenicity testing.
AAA(B) Freshwater aquatic invertebrate toxicity and pathogenicity test.
AAA(C) Plant studies--aquatic.
AAA(viii) Required if product is applied on land or in fresh water and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
AAA(A) Estuarine and marine animal toxicity and pathogenicity test.
AAA(B) Plant studies--estuarine or marine.
AAA(ix) Required if product is applied in marine or estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests:
AAA(A) Avian single dose oral toxicity and pathogenicity test.
AAA(B) Avian injection pathogenicity test.
AAA(C) Estuarine and marine animal toxicity and pathogenicity test.
AAA(x) Required when toxic effects on nontarget terrestrial wildlife or aquatic organisms are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the
mocrobial agent to the affected nontarget terrestrial wildlife or aquatic organisms.
AAA(xi) Required when:
AAA(A) Pathogenic effects are observed in Tier I avian tests at a level equal to the adjusted host equivalent amount.
AAA(B) Chronic, carcinogenic, or teratogenic effects are reported in tests required by paragraph (c)(1) of this section for evaluating hazard to humans and domestic animals.
[[Page 125]]
AAA(C) Tier II Environmental expression testing indicates that exposure of terrestrial animals to the microbial agent is likely.
AAA(xii) Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I
tests.
AAA(xiii) Required when both of the following conditions are met:
AAA(A) Pathogenic effects at actual or expected field residue exposure levels are reported in Tier III.
AAA(B) The agency determines that quarantine methods will prevent the microbial pest control agent from contaminating areas adjacent to the test area.
AAA(xiv) Required if, after an analysis of the microbial agent's properties, the individual use patterns, and the results of previous nontarget organism and environmental expression tests, it
is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments, including those of the water column and bottom sediments. When
a microbial pest control agent is used in or is expected to transport to water from the intended use site, major considerations for requiring these infectivity tests include, but are not
limited to:
AAA(A) Infectivity or pathogenicity demonstrated in previous testing.
AAA(B) Viability of the microorganism in natural waters as demonstrated in Tier II tests.
AAA(xv) Required if the product is transported from the site of application by air, soil, or water or transmission by other animals. The extent of movement will be determined by the
environmental expression tests in Tier II.
AAA(xvi) The Agency expects that Tier IV requirements would be imposed retrospectively--after product registration as post registration monitoring, since it is unlikely a registrant would
pursue registration of a microbial agent posing potential hazards such that testing beyond Tier III is required.
AAA(xvii) Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of
available laboratory data, use patterns, and exposure rates.
AAA(xviii) Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and
growth of natural populations are observed) are required if laboratory data indicate adverse long-term, cumulative, or life-cycle effects may result from intended use.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
[[Page 126]]
Appendix A to Part 158--Data Requirements for Registration: Use Pattern
Index
How to use this Index:
1. Identify the Pesticide Use Site Group listed below (e.g.,
agricultural crops, forests, ornamental plants) that covers the specific
use pattern of interest to you.
2. Find your specific use pattern under the appropriate Pesticide
Use Site Group.
3. Identify the general use pattern that corresponds to your
specific use pattern.
4. Use the general use pattern in determining applicable data
requirements on the Data Requirements tables presented in Sec. Sec.
158.120 through 153.170.
Pesticide use site group
1. Agricultural Crops.
2. Ornamental Plants and Forest Trees.
3. General Soil Treatment and Composting.
4. Processed or Manufactured Products, and food or feed containers
or dispensers.
5. Pets and Domestic Animals.
6. Agricultural Premises and Equipment.
7. Household.
8. Wood or Wood Structure Protection Treatments.
9. Aquatic sites.
10. Noncrop, wide area, and general indoor/outdoor treatments.
11. Antifouling treatments.
12. Commercial and Industrial Uses.
13. Domestic and Human Use.
14. Miscellaneous Indoor Uses.
------------------------------------------------------------------------
Specific use patterns--listed according to Corresponding general use
use site group pattern
------------------------------------------------------------------------
1. Agricultural crops
Small fruits Terrestrial food crop
Caneberries (e.g., raspberry, dewberry)
Bushberries (e.g., blueberry, currant)
Vine fruits (e.g., grape, kiwi fruit)
Strawberry
Cranberry
Pome fruits (e.g., apple, quince)
Stone fruits (e.g., peach, cherry)
Nut crops--tree & shrub (e.g., pecan,
filbert)
Other temperate fruits (e.g., persimmon,
pawpaw)
Tropical and subtropical fruits
Citrus
Banana and plantain
Palm fruits and nuts (e.g., date, coconut)
Pineapple
Other fruits and nuts
Beverage crops
Woody--cocoa, coffee, tea
Herbaceous--chicory, mint
Flavoring and spice crops
Woody--leaf/stem, root, seed and pod
Herbac.--leaf/stem, root, seed and pod
Vegetables--leaf/stem, root, seed and pod,
fruiting vegetables, cucurbits
Commercial annual (e.g., tomato, bean)
Commercial perennial (e.g., asparagus,
rhubarb)
Greenhouse (commercial) Greenhouse food crop
Mushrooms
Nursery/seed crop/medical crop/tobacco Greenhouse non-food crop
Fiber crops Terrestrial food crop
Cotton
Others--(e.g., flax)
Forage crops
Typical grasses--annual (e.g., sudan
grass)
Typical grasses--perennial (e.g.,
bromegrass)
Corn and sorghum
Small grains for forage (e.g., rye)
Perennial legumes (e.g., white clover)
Annual legumes (e.g., crotalaria, soybean)
Crop harvest residue (peanut vines, beet
tops, etc.)
Grain and edible seed crops
Corn
Rice Aquatic food crop
Wheat, barley, rye, oats Terrestrial food crop
Sorghum
Alfalfa
Other grains
Other nongrains (e.g., squash, pumpkin)
Buckwheat
Sesame
Peanut
Sunflower
Seed sprout crops
Mung bean, red clover, soybean, alfalfa,
etc.
Nonlegume crops (e.g., wheat, radish,
black mustard)
Crops grown exclusively for seed for
planting
Sugar crops
Stored raw agricultural commodities Indoor
Honey (principal nectar-producing crops)
Sugar beet
Sugarcane
Sugar maple
Sorghum (for sugar)
Crops for smoking and chewing Terrestrial nonfood crop
--field
--shade
--storage
--greenhouses
Sapodilla (for chewing gum) Terrestrial food crop
Oil crops
Annual herbaceous crops
Perennial herbaceous crops
Tropical/subtropical woody crops
Drug and medicinal crops Terrestrial nonfood crop
Annual herbaceous crops
Perennial herbaceous crops
Temperate woody crops
Tropical/subtropical wood crops
[[Page 127]]
2. Ornamental plants and forest trees
Ornamental plants Terrestrial nonfood crop
Annual garden plants
Temperate perennial nonfood garden herbs
Commercial greenhouse crops Greenhouse nonfood crop
Houseplants Indoor
Home and retail greenhouse and
conservatory plants
Public display plantings Terrestrial nonfood crop
Bulb, corm, and tuber ornamentals
Subtropical/tropical garden evergreen
plants (dry--e.g., agave)
Subtropical/tropical garden evergreen
plants (moist--e.g., ferns)
Groundcovers
Aquatic plants (e.g., waterlilies) Aquatic nonfood use
Ornamental trees, shrubs, and vines (woody) Terrestrial nonfood crop
Deciduous temperate broadleaf
Evergreen temperate broadleaf
Deciduous temperate conifer
Evergreen temperate conifer
Tropical/subtropical broadleaf
Tropical/subtropical conifer
Tropical/subtropical miscellaneous (e.g.,
cycad, tree fern, bamboo)
Lawn and turf grasses--ornamental Terrestrial nonfood crop
or domestic outdoor
Cool season Winter grasses (bent,
bluegrass, fescue, etc.)
Summer grasses (zoysia, bermudagrass,
etc.)
Ornamental bunch grasses (pampasgrass,
blue fescue)
Forest trees--nonornamental--trees forests, Forestry
plantings
Deciduous temperate (broadleaf)
Evergreen temperate (broadleaf)
Deciduous and evergreen conifers
Tropical/subtropical broadleaf
Tropical/subtropical conifer
Forest tree nurseries--Temperate broadleaf
trees
Temperate conifer trees
Forest trees: dead trees/logs/stumps in the
forest or in plantings
3. General soil treatment and composting
General soil treatments Terrestrial nonfood crop
Soil application with no mention of crops
to be grown (potting soil, top soil).
Manure
Composts
Cull piles
Mulches
4. Processed or manufactured products, and
food or feed containers or dispensers
Processed vegetables, fruits, and nuts Indoor
Fruits
Leafy vegetables
Root vegetables
Fruited vegetables
Nuts
Peanuts
Seeds (sesame, sunflower)
Dried processed
Fruits
Vegetables
Tobacco
Beverages (tea, coffee)
Herbs and spices
Animal Feeds
Cattle (beef)
Cattle (dairy)
Goat (nondairy)
Goat (dairy)
Horse, mule, donkey
Poultry (chicken, turkey, etc.)
Sheep (meat)
Sheep (wool)
Swine
Dog
Cat
Other pets (including birds)
Fur-bearing stock
Other meat-producing stock (e.g., rabbit)
Fish food (commercial)
Fish food (pet)
Birdseed
Processed grain products for human
consumption
Corn
Soybean
Wheat
Other grains (rice, barley, etc.)
Cereal foods
Flour
Baked goods
Farinaceous products
Processed animal products for human
consumption
Cheese
Egg yolks
Meats, including fish and poultry
Milk
Processed plant products for human
consumption
Chocolate
Candy
Sugar
Yeast
Citrus pulp
Chewing gum
Cigarettes, etc.
Herbs and spices
Pickles
Glazed fruits
Jellies
Seed oils
Fruit syrups (e.g., cola)
Fruit juices
Fermentation beverages (wine, beer,
whiskey, vinegar)
Processed or manufactured nonfood plant
and animal products
Textiles, fabrics, fibers
Fur and hair products
Leather products
Food and feed containers, dispensers, and
processing equipment
Airtight storages--large (empty/full)
Airtight storages--small (empty/full)
Fumigation chambers
Bins
Elevators
Storage areas--(empty/full)
[[Page 128]]
Processing or handling equipment and
machinery (other than food processing)
5. Pets and domestic animals--animals and
their man-made premises
Dairy cattle--lactating Indoor
Dairy cattle--nonlactating
Dairy cattle--heifers, calves
Goats--lactating
Goats--nonlactating
Goats--young (kids)
Fur- and wool-bearing animals
Goats
Sheep
Mink
Chinchilla
Rabbit
Fox
Nutria
Meat animals (mammals)
Cattle (and calves)
Goats (and kids)
Horses
Rabbits
Sheep (and lambs)
Swine
Bison
Reindeer
Poultry (meat, eggs)
Chickens
Turkeys
Ducks, geese
Guineas, pheasants, quail, etc.
Honey production
Bees
Beehives
Honeycombs
Fish and shellfish production Aquatic food use
Hatchery buildings
Culture ponds, containers
Animals for labor, display, riding, racing, Indoor
lab use, etc.
Dogs
Horses, donkeys, mules
Guinea pigs
Mice
Rats
Gerbils
Hamsters
Monkeys
Cats
Chickens, birds
Wild rodents
Alfalfa leafcutting bee (pollinator)
Alkaline bee (pollinator)
Zoo ruminants
Zoo ungulates
Zoo canines
Zoo felines
Zoo primates
Zoo reptiles
Zoo amphibians
Zoo birds
Zoo--others
Aquarium fish
Animals for pets, including their cages,
bedding, nests, etc.
Dogs
Cats
Birds
Rodents
Lagomorphs
Fish
Amphibians
Reptiles
Primates
Other vertebrates
6. Agricultural premises and equipment
Egg handling facilities and equipment Indoor
Egg washers
Egg rooms
Hatching egg treatments
Hatching egg rooms
Hatching egg equipment
Egg packing plants and hatcheries
Milk handling facilities and equipment
Milk storage rooms
Milking stalls and parlors
Milking machines, milk tanks, etc.
Teat cups, liners, etc.
Milk processing equipment
7. Household
Non-food area and sites Indoor
Closets, storage areas
Basements, cellars
Bedrooms
Attics
Recreation rooms
Living rooms
Baseboards, window sills, etc.
Plumbing fixtures
Sickrooms
Food-handling and food storage areas
Kitchens
Dining rooms
Pantry and food storage shelving
Household contents and space
Air
Beds
Rugs
Book cases
Furs, fabrics, blankets
Play pens
Sickroom utensils
Filters for air vents, air conditioners,
furnaces, etc.
Outdoor areas (Noncommercial homeowner use) Domestic outdoor or
terrestrial food crop
Home garden, orchards
Porches Domestic outdoor
Patios
Foundations
Steps
Eaves
Yards, lawn, turf
Domestic ornamental plantings
8. Wood or Wood Structure Protection
Treatments
Buildings (for termite, powderdust beetle Domestic outdoor or indoor
controls, etc.)
Unseasoned forest products
Seasoned forest products
Finished wood products
Wood pressure treatments
Plant-growing wood structures and containers
Wood containers for nonfood, nonfeed uses
9. Aquatic sites
Food processing water systems Aquatic food crop
Poultry and livestock drinking water
Pulp and papermill systems Aquatic noncrop
Swimming pool water
Industrial disposal systems
Industrial ponds
[[Page 129]]
Human drinking water Aquatic food crop
Cooling water towers Aquatic noncrop
Agricultural irrigation water, and ditches Aquatic food crop
Agricultural drainage water and ditches
Sewage systems and drainfields Aquatic noncrop
Dishwashing water Indoor
Domestic and commercial nonpotable water Aquatic noncrop
Lakes, ponds, impounded water
Streams, rivers, canals
Swamps, marshes, wetlands
Air conditioner water
Humidifier water
Air washer water systems
Secondary oil recovery injection water
Heat exchange water system
Polluted water
Bait boards (floating--for vertebrate
control)
Catch basins, puddles, tree holes
Estuaries, tidal marshes
Commercial and sport fish-bearing waters Aquatic food crop
10. Noncrop, wide area, and general indoor/
outdoor treatments
Uncultivated agricultural areas (nonfood Terrestrial noncrop
producing)
Farmyards
Fuel storage areas
Fence rows
Rights-of-way
Fallow land Terrestrial food crop
Soil bank land Terrestrial noncrop
Barrier strips
Uncultivated nonagricultural areas (outdoor)
Airports
Recreation areas, fairgrounds, race tracks,
tennis courts, etc.
Campgrounds
Recreation area structures
Highway rights-of-way
Railroad rights-of-way
Utility rights-of-way
Sewage disposal areas
Industrial sites (lumberyards, tank farms,
etc.)
Paved areas
Private roads and walks
Fencerows and hedgerows (nonagricultural)
Directed Pest Control to Pests' Nests, etc., Terrestrial noncrop or
and for Traps indoor
Diseased beehives
Nuisance bee nests
Ant mounds, hills, dens
Termite mounds
Insect traps (chemical lures)
Repellents and irritants to pests (when
not covered by other sites)
Wide area and general indoor/outdoor
treatments
Rural areas (unspecified)
Urban areas (unspecified)
Public buildings and structures
Animal burrow entrances, dens, tunnels
Animal nests
Animal trails
Mammal feeding areas
Nonagricultural areas for public health
treatments
Bird roosting, nesting areas
Bird feeding areas
11. Antifouling Treatments
Sites for marine exposures Aquatic noncrop
Boat bottoms and other submersed
structures
Steel
Fiberglass
Aluminum
Wood
Plastic
Other substances and materials
Crab pots and lobster pots
Sites for fresh water exposures
Cooling tower influent conduits
12. Commercial and Industrial Uses
Transportation Facilities Indoor
Bus
Truck and Trailer
Containerized units
Railroad cars
Aircraft
Ships/barges
Auto, taxis
Recreational vehicles
Shipping containers
Food and feed processing plants
Bakeries
Bottlers
Canneries
Dairies, creameries, milk processing
plants
Feed mills, feed stores
Fresh fruit packing and processing
Meat processing
Poultry processing
Wineries, wine cellars
Flour mills, machinery, warehouses, bins,
elevators
Egg processing
Candy and confectionary plants
Sugar processing, cane mills, etc.
Cider mills
Dry food products plants
Tobacco processing
Air treatment for processing and
transportation of foods
Beverage processing
Nut processing
Cereal processing
Seafood processing
Vegetable oil processing
Spice mills
Vinegar processing
Farinaceous processing (noodles, etc.)
Mushroom processing
Dried fruit processing
Pickle processing
Ice plants
Chocolate processing
Fruit juice processing
Eating establishments (all)
Food handling areas
Food serving areas
Eating establishment nonfood areas
Air treatment for eating establishments
Food storage equipment (coolers,
refrigerators, etc.)
Eating and serving utensils (spoons, etc.)
Food marketing, storage, and distribution
[[Page 130]]
Food dispensing and vending equipment
Food stores, markets, stands
Meat and fish markets
Food catering facilities
Food marketing, storage, and distribution
equipment and utensils
Hospitals and related institutions and
facilities
Critical premises (e.g., burn wards, etc.)
Hospital patient premises (wards,
emergency rooms, etc.)
Noncritical premises (labs, lounges,
lobbies, storage)
Critical items (hypodermic needles, dental
instruments, catheters, etc.)
Noncritical items (bedpans, carpets,
furniture, etc.)
Air treatment (also to ambulances)
Janitorial equipment
Barber and beauty shop instruments and
equipment
Morgues, mortuaries, and funeral homes
Premises (embalming rooms, etc.)
Equipment (tables, etc.)
Instruments
Burial vaults, mausoleums
Air treatment
Commercial, institutional, and industrial
Maintenance, Buildings, and Structures
Locker rooms, equipment
Gyms, bowling alleys, and equipment
Telephones and booths
Shower rooms, mats, and equipment
Cotton mill premises and equipment
Auditoriums and stadiums
Factories
Rendering plants
Loading areas, ramps
School buildings and equipment
Office buildings
Laundries
Fuels from Crops (alcohol, methane)
Fossil fuels (e.g., oils, jet fuel)
Seed oils
Paper
Pesticide materials preservation and
protection
Rodenticide baits (protection against
insects)
Dried plant parts (pyrethrum, red squill,
rotenone, sabadilla)
Paints
Preservatives and protectants
Grains
Hay, silage
Adhesives
Coatings (asphalt and lacquer)
Fuels
Leather and leather products
Leather processing liquors
Metalworking cutting fluids
Oil recovery drilling muds and packer
fluids
Paints (latex)
Paper and paper products
Plastic products
Resin emulsions
Rubber (natural) products
Specialty products (polishes, cleansers,
dyes, etc.)
Textiles, textile fibers, and cordage
Wet-end additives, etc. (pulp sizing,
alum, casein, printing pastes)
Disposable diapers
Wool, hair, mohair, furs, felt, feathers,
etc.
Electrical supplies, cables, and equipment
13. Domestic and Human Use
Human Body and Hair Indoor
Fiber product protection (Moth,
mildew-proofing)
Clothing
Upholstery
Ornamental fabrics (draperies, tapestries)
Ropes
Sail cloth
Human articles and materials
Bedding, blankets, mattresses
(Treatments to) hair, body, clothing
(while being worn)
Clothing
Face gear (goggles, face masks, etc.)
Headgear (safety helmets, headphones,
etc.)
Wigs
Contact lenses
Dentures, toothbrushes, mouthpieces to
musical instruments, etc.
Brick, asbestos, etc.
Wood surfaces
Leather surfaces
Fabric surfaces
Paper/paperboard surfaces
Specialty uses
Museum collectors (preserved animal and
plant specimens)
Military uses--not specified
Quarantine uses--not specified
DHHS/FDA uses--not specified
Filters (air conditioning, air, and
furnace)
Biological specimens
Underground cables
Cuspidors, spittoons
Vomitus
Human wastes
Air sanitizers
Diapers
Laundry equipment (carts, chutes, tables,
etc.)
Dust control--products and equipment
(mops, etc.)
Dry cleaning
Carpets
Upholstery
Bathrooms, toilets bowls, and related sites
Bathroom premises
Toilet bowls and urinals
Toilet tanks
Portable toilets, chemical toilets
Vehicular holding tanks
Bathroom air treatment
Diaper pails
Refuse and soild waste
Refuse and solid waste containers
Refuse and solid waste transportation and
handling equipment
Garbage dumps
Household trash compactors
[[Page 131]]
Garbage disposal units, food disposals
Incinerators
14. Miscellaneous Indoor Uses
Surface Treatments Indoor
Hard nonporous surfaces (painted, tile,
plastic, metal, glass, etc.)
Hard porous surfaces (cement, plaster)
Camping equipment and gear
Grooming instruments (brushes, clippers,
razors, etc.)
Laundry, cleaning, and dry cleaning
------------------------------------------------------------------------
PART 159_STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents
Subparts A-C [Reserved]
Subpart D_Reporting Requirements for Risk/Benefit Information
Sec.
159.152 What the law requires of registrants.
159.153 Definitions.
159.155 When information must be submitted.
159.156 How information must be submitted.
159.158 What information must be submitted.
159.159 Information obtained before promulgation of the rule.
159.160 Obligations of former registrants.
159.165 Toxicological and ecological studies.
159.167 Discontinued studies.
159.170 Human epidemiological and exposure studies.
159.178 Information on pesticides in or on food, feed, or water.
159.179 Metabolites, degradates, contaminants, and impurities.
159.184 Toxic or adverse effect incident reports.
159.188 Failure of performance information.
159.195 Reporting of other information.
Authority: 7 U.S.C. 136-136y.
Source: 63 FR 49388, Sept. 19, 1997, unless otherwise noted.
Subparts A-C [Reserved]
Subpart D_Reporting Requirements for Risk/Benefit Information
Sec. 159.152 What the law requires of registrants.
(a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) states: ``If at any time after the registration
of a pesticide the registrant has additional factual information
regarding unreasonable adverse effects on the environment of the
pesticide, he shall submit such information to the Administrator.''
(b) Section 152.50(f)(3) of this chapter requires applicants to
submit, as part of an application for registration, any factual
information of which he is aware regarding unreasonable adverse effects
of the pesticide on humans or the environment, which would be required
to be reported under section 6(a)(2) if the product were registered.
(c) Compliance with this part will satisfy a registrant's
obligations to submit additional information pursuant to section 6(a)(2)
and will satisfy an applicant's obligation to submit additional
information pursuant to Sec. 152.50(f)(3) of this chapter.
Sec. 159.153 Definitions.
(a) For the purposes of reporting information pursuant to FIFRA
section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40
CFR part 152 apply to this part unless superseded by a definition in
paragraph (b) of this section.
(b) For purposes of reporting information pursuant to FIFRA section
6(a)(2), the following definitions apply only to this part:
Established level means a tolerance, temporary tolerance, food
additive regulation, action level, or other limitation on pesticide
residues imposed by law, regulation, or other authority.
Formal Review means Special Review, Rebuttable Presumption Against
Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA
section 6(b) cancellation proceeding, whether completed or not.
Hospitalization means admission for treatment to a hospital, clinic
or other health care facility. Treatment as an out-patient is not
considered to be hospitalization.
Maximum contaminant level (MCL) means the maximum permissible level,
established by EPA, for a contaminant in water which is delivered to any
user of a public water system.
Non-target organism means any organism for which pesticidal control
was either not intended or not legally permitted by application of a
pesticide.
[[Page 132]]
Pesticide means a pesticide product which is or was registered by
EPA, and each active ingredient, inert ingredient, impurity, metabolite,
contaminant or degradate contained in, or derived from, such pesticide
product.
Qualified expert means one who, by virtue of his or her knowledge,
skill, experience, training, or education, could be qualified by a court
as an expert to testify on issues related to the subject matter on which
he or she renders a conclusion or opinion. Under Rule 702 of the Federal
Rules of Evidence, a person may be qualified as an expert on a
particular matter by virtue of ``knowledge, skill, experience, training,
or education.'' In general, EPA wants registrants to report information
when a person has relevant expert credentials, e.g., a medical doctor
giving a medical opinion, a plant pathologist giving an opinion on plant
pathology, etc.
Registrant includes any person who holds, or ever held, a
registration for a pesticide product issued under FIFRA section 3 or
24(c).
Similar species means two or more species belonging to the same
general taxonomic groups: The general taxonomic groups for purposes of
this requirement are: mammals, birds, reptiles, amphibians, fish,
aquatic invertebrates, insects, arachnids, aquatic plants (including
macrophyte, floating, and submerged plants), and terrestrial (all non-
aquatic) plants.
Water reference leve means the level specified in paragraph (1) or
(2) of this definition, whichever is lower.
(1) Ten percent of the maximum contaminant level (MCL) established
by EPA, or if no MCL has been established by EPA, 10 percent of the most
recent draft or final long-term health advisory level (HAL) established
by EPA, or if EPA has not published or proposed an MCL or HAL, the
lowest detectable amount of the pesticide.
(2) The ambient water quality criteria for the protection of aquatic
life, established by EPA pursuant to section 304(a) of the Clean Water
Act.
[62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998]
Sec. 159.155 When information must be submitted.
(a) The following reportable information must be received by EPA not
later than the 30th calendar day after the registrant first possesses or
knows of the information:
(1) Scientific studies described in Sec. 159.165.
(2) Information about discontinued studies described in Sec.
159.167.
(3) Human epidemiological and exposure studies described in Sec.
159.170.
(4) Detection of a pesticide in or on food or feed described in
Sec. 159.178(a).
(5) Detection of metabolites, degradates, contaminates, impurities
described in Sec. 159.179.
(6) Failure of performance studies described in Sec. 159.188(a)(2),
(b)(2), and (c).
(7) Other information described in Sec. 159.195.
(b) Reportable information concerning detections of pesticides in
water described in Sec. 159.178(b), adverse effects incidents described
in Sec. 159.184(a), and efficacy failure incidents described in Sec.
159.188(a)(1) and (b)(1) must be reported according to the time frames
set forth in Sec. 159.184(d).
(c) EPA may, in its discretion, notify a registrant in writing of a
different reporting period that will apply to specific types of
reportable information or eliminate reporting requirements entirely.
Such notification supersedes otherwise applicable reporting requirements
set forth in this part.
(d) For purposes of this part, a registrant possesses or knows of
information at the time any officer, employee, agent, or other person
acting for the registrant first comes into possession of, or knows of,
such information; provided that, such person performs any activities for
the registrant related to the development, testing, sale or registration
of a pesticide or the person could be reasonably expected to come into
possession of information otherwise reportable under this part. In the
case of information known to or possessed by an agent or other person
acting for the registrant, a registrant is responsible for such
information only if the agent or other person acquired such information
while acting for the registrant.
[63 FR 33582, June 19, 1998]
[[Page 133]]
Sec. 159.156 How information must be submitted.
A submission under FIFRA section 6(a)(2) must be delivered as
specified in either paragraph (a) or (b) of this section, and must meet
the other requirements of this section:
(a) Be mailed by certified or registered mail to the following
address, or such other address as the Agency may subsequently specify in
writing:
Document Processing Desk--6(a)(2), Office of Pesticide Programs--7504C,
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
(b) Be delivered in person or by courier service or by such other
methods as the Agency deems appropriate to the following address, or to
such other address as the Agency may subsequently specify in writing:
Document Processing Desk-6(a)(2), Office of Pesticide Programs, Room
266A, Crystal Mall 2, 1801 South Bell St., Arlington, Virginia
22202.
(c) Include a cover letter which contains the information requested
in paragraphs (d) and (e) of this section, and a prominent statement
that the information is being submitted in accordance with FIFRA section
6(a)(2).
(d) Contain the name of the submitter, registrant name and
registration number, date of transmittal to EPA, the type of study or
incident being reported under Sec. Sec. 159.165 through 159.195, and a
statement of why the information is considered reportable under this
part.
(e) Identify the substance tested or otherwise covered by the
information (including, if known, the EPA registration number(s) to
which the information pertains, and if known, the CAS Registry Number).
(f) In reporting incidents, provide the data listed in Sec.
159.184, to the extent such information is available.
(g) In submitting scientific studies, follow the procedures set
forth in Sec. 158.32 of this chapter.
(h) If the information is part of a larger package being submitted
in order to comply with another provision of FIFRA (e.g., sections
3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual
studies being submitted under this part.
(i) If a claim of confidentiality is made under FIFRA section 10 for
information relating to any part of a study or incident report contained
in the submission, follow the procedures set forth in Sec. 158.33 of
this chapter regarding the identification and segregation of information
claimed to be confidential.
(j) If a submission includes a study subject to the flagging
requirements of Sec. 158.34 of this chapter, comply with the
requirements of that section, and, if the flagging statement is
positive, identify it as 6(a)(2) information in the transmittal.
(k) If a submission is a follow-up to an earlier study or incident
report submitted to EPA, the transmittal must state that fact, and must
cite the earlier submission, as follows:
(1) If the earlier submission was a study to which EPA assigned a
Master Record Identifier number (MRID), cite the MRID.
(2) If the previous submission was an incident report to which no
MRID number was assigned, cite the date of the initial submission of the
incident information or report.
[63 FR 49388, Sept. 19, 1997, as amended at 69 FR 39864, July 1, 2004]
Sec. 159.158 What information must be submitted.
(a) General. Information which is reportable under this part must be
submitted if the registrant possesses or receives the information, and
the information is relevant to the assessment of the risks or benefits
of one or more specific pesticide registrations currently or formerly
held by the registrant. Information relevant to the assessment of the
risks or benefits also includes conclusion(s) or opinion(s) rendered by
a person who meets any of the following:
(1) Who was employed or retained (directly or indirectly) by the
registrant, and was likely to receive such information.
(2) From whom the registrant requested the opinion(s) or
conclusion(s) in question.
(3) Who is a qualified expert as described in Sec. 159.153(b).
(b) Exceptions--(1) Clearly erroneous information. Information need
not be submitted if before that date on which
[[Page 134]]
the registrant must submit such information if all of the following
conditions are met:
(i) The registrant discovers that any analysis, conclusion, or
opinion was predicated on data that were erroneously generated,
recorded, or transmitted, or on computational errors.
(ii) Every author of each such analysis, conclusion, or opinion, or
as many authors as can be contacted through the use of reasonable
diligence, has acknowledged in writing that the analysis, conclusion, or
opinion was improper and has either corrected the original analysis,
conclusion, or opinion accordingly, or provided an explanation as to why
it cannot be corrected.
(iii) As a result of the correction, the information is no longer
required to be reported under FIFRA section 6(a)(2), or if no correction
was possible, the authors agree that the original analysis, conclusion
or opinion has no scientific validity.
(2) Previously submitted information. Information regarding an
incident, study, or other occurrence need not be submitted if before the
date on which the registrant must submit such information, the
registrant is aware that the reportable information concerning that
incident, study, or other occurrence is contained completely in one of
the following:
(i) Documents officially logged in by the EPA Office of Pesticide
Programs.
(ii) EPA publications, EPA hearing records, or publications cited in
EPA Federal Register notices.
(iii) Any other documents which are contained in the official files
and records of the EPA Office of Pesticide Programs.
(iv) Any documents officially logged in by the EPA Office of
Pollution Prevention and Toxics under the provisions of section 8(e) of
the Toxic Substances Control Act, provided that if the information
pertains to a chemical compound which, subsequent to the submission of
data under section 8(e), becomes the subject of an application for
registration as a pesticide active ingredient, information is submitted
to the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
(3) Publications. A published article or report containing
information otherwise reportable under this part need not be submitted
if it fits into either of the following categories:
(i) Any scientific article or publication which has been abstracted
in a recognized database of scientific and medical literature, such as
Medline, ENBASE, Toxline or Index Medicus, if the abstract in question
clearly identified the active ingredient or the registered pesticide(s)
to which the information pertains. Otherwise reportable information
received by or known to the registrant prior to publication of an
abstract concerning the information must be reported and may not be
withheld pending such publication.
(ii) Reports or publications which have been made available to the
public by any of the following Federal agencies: Centers for Disease
Control and Prevention, Consumer Products Safety Commission, Department
of Agriculture, Department of the Interior, Food and Drug Administration
or any other agency or institute affiliated with the Department of
Health and Human Services. Otherwise reportable information concerning
research which was performed, sponsored, or funded by the registrant
which may also appear in forthcoming Government reports or publications
must be reported and may not be withheld pending publication.
(4) Information concerning former inerts, contaminants or
impurities. Notwithstanding any other provisions of this part, a
registrant need not report information concerning a chemical compound
that was at one time an inert ingredient or a contaminant or impurity of
a pesticide product, and would otherwise be reportable under this part,
if both of the following conditions are met:
(i) The compound has been eliminated from its registered product due
to changes in manufacturing processes, product formulation or by other
means.
(ii) The registrant has informed the appropriate product manager in
the Office of Pesticide Programs in writing of the presence previously
of the inert,
[[Page 135]]
contaminant or impurity in the product and its subsequent elimination
from the product.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]
Sec. 159.159 Information obtained before promulgation of the rule.
(a) Notwithstanding any other provision of this part, information
held by registrants on August 17, 1998 which has not been previously
submitted to the Agency, but which is reportable under the terms of this
part, must be submitted to the Agency if it meets any of the following
criteria:
(1) Information is otherwise reportable under Sec. 159.184, and
pertains to an incident that is alleged to have occurred on or after
January 1, 1994, and to have involved any of the following:
(i) A fatality or hospitalization of a human being.
(ii) A fatality of a domestic animal.
(iii) A fatality or fatalities to fish or wildlife, if the incident
meets the criteria for the exposure type and severity category
designation ``W-A'' set forth in Sec. 159.184(c)(5)(iii).
(2) Submission of the information is requested by the Agency
pursuant to Sec. 159.195(c).
(b) If a registrant possesses information required to be submitted
by paragraph (a)(1) of this section, the registrant must submit on or
before June 16, 1999 in accordance with Sec. 159.156(c), (d), and (e)
an inventory of the incidents that meet the requirements of paragraphs
(a)(1) of this section. Such an inventory must include the separate
number of incidents that meet the requirements of paragraphs (a)(1)(i),
(a)(1)(ii), and (a)(1)(iii) of this section, and for each type of
incident, the total numbers of fatalities or hospitalizations involved.
(c) If a registrant possesses information required to be submitted
by paragraph (a)(2) of this section, the information must be submitted
in accordance with any schedule contained in the Agency's request for
the information.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at
63 FR 41193, Aug. 3, 1998]
Sec. 159.160 Obligations of former registrants.
(a) General. A former registrant is obliged to continue to submit
information concerning the registration of a pesticide product
previously held by the registrant and otherwise reportable under the
provisions of this part for a period of 5 years after the registration
of the pesticide product has been canceled or transferred to another
registrant, with the exceptions provided by paragraph (b) of this
section.
(b) Exceptions. Notwithstanding the provisions of paragraph (a) of
this section, a former registrant is not obligated to report information
pursuant to this part if any of the following conditions are applicable:
(1) The information is first obtained by the person more than 1 year
after the date on which the person ceased to hold the registration of
the product to which the information pertains, and the person holds no
active pesticide registrations, or for some other reason cannot
reasonably be expected to receive information concerning the formerly
registered product.
(2) The information is associated solely with an inert ingredient,
contaminant, impurity, metabolite, or degradate contained in a product,
and the information is first obtained by the person more than 1 year
after the date upon which the person ceased to hold the registration of
the product.
(3) The information is associated with an active ingredient or a
formerly registered product, and the active ingredient or every active
ingredient contained in the formerly registered product has not been
contained in any pesticide product registered in the United States for
any part of the 3-year period preceding the date on which the person
first obtained the information.
(4) The information pertains solely to a formerly registered product
that no longer meets the definition of ``pesticide'' in section 2(u) of
FIFRA (7 U.S.C. section 136(u)).
(c) Information arising from litigation. Notwithstanding any other
provisions of this section, a former registrant is obliged to submit
information otherwise reportable under this part concerning formerly-
registered pesticide
[[Page 136]]
products which arises in the course of litigation concerning the effects
of such products, regardless of when the information is first acquired,
provided that neither of the provisions of paragraphs (b)(3) or (b)(4)
of this section are met. Such information shall be submitted in the same
manner and according to the same schedules as it would have to be
submitted by a current registrant of a pesticide product to which the
information pertained.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]
Sec. 159.165 Toxicological and ecological studies.
Adverse effects information must be submitted as follows:
(a) Toxicological studies. (1) The results of a study of the
toxicity of a pesticide to humans or other non-target domestic organisms
if, relative to all previously submitted studies, they show an adverse
effect under any of the following conditions:
(i) That is in a different organ or tissue of the test organism.
(ii) At a lower dosage, or after a shorter exposure period, or after
a shorter latency period.
(iii) At a higher incidence or frequency.
(iv) In a different species, strain, sex, or generation of test
organism.
(v) By a different route of exposure.
(2) Acute oral, acute dermal, acute inhalation or skin and eye
irritation studies in which the only change in toxicity is a numerical
decrease in the median lethal dose (LD50), median lethal
concentration (LC50) or irritation indices, are not
reportable under this part unless the results indicate a more
restrictive toxicity category for labeling under the criteria of 40 CFR
156.10(h).
(b) Ecological studies. The results of a study of the toxicity of a
pesticide to terrestrial or aquatic wildlife or plants if, relative to
all previously submitted studies, they show an adverse effect under any
of the following conditions:
(1) At levels 50 percent or more lower than previous acute toxicity
studies with similar species, including determinations of the median
lethal dose (LD50), median lethal concentration
(LC50), or median effective concentration (EC50).
(2) At lower levels in a chronic study than previous studies with
similar species.
(3) In a study with a previously untested species the results
indicate the chronic no observed effect level (NOEL) is 10 percent or
less of the lowest LC50 or LD50 for a similar
species.
(4) For plants when tested at the maximum label application rate or
less, if either of the following conditions is met:
(i) More than 25 percent of terrestrial plants show adverse effects
on plant life cycle functions and growth such as germination, emergence,
plant vigor, reproduction and yields.
(ii) More than 50 percent of aquatic plants show adverse effects on
plant life cycle functions and growth such as germination, emergence,
plant vigor, reproduction and yields.
(c) Results from a study that demonstrates any toxic effect (even if
corroborative of information already known to the Agency), must be
submitted if the pesticide is or has been the subject of a Formal Review
based on that effect within 5 years of the time the results are
received. Within 30 calendar days of the publication of a Notice of
Commencement of a Formal Review in the Federal Register, all information
which has become reportable due to the commencement of the Formal Review
must be submitted.
(d) Incomplete studies. Information from an incomplete study of the
toxicity to any organism of a registered pesticide product or any of its
ingredients, impurities, metabolites, or degradation products which
would otherwise be reportable under paragraphs (a), (b) or (c) of this
section must be submitted if the information meets any one of the
folowing three sets of criteria:
(1) Short-term studies. A study using a test regimine lasting 90
calendar days or less, and all of the following conditions are met:
(i) All testing has been completed.
(ii) A preliminary data analysis or gross pathological analysis has
been conducted.
(iii) Final analysis has not been completed.
[[Page 137]]
(iv) A reasonable period for completion of the final analysis not
longer than 90 calendar days following completion of testing has
elapsed.
(v) Comparable information concerning the results of a completed
study would be reportable.
(2) Long-term studies. A study using a test regimine lasting 90
calendar days or less, and all of the following conditions are met:
(i) All testing has been completed.
(ii) A preliminary data analysis or gross pathological analysis has
been conducted.
(iii) Final analysis has not been completed.
(iv) A reasonable period of completion of final analysis (not longer
that 1 year following completion of testing) has elapsed.
(v) Comparable information concerning the results of a completed
study would be reportable.
(3) Serious adverse effects. Any study in which testing or analysis
of results is not yet complete but in which serious adverse effects have
already been observed which may reasonably be attributed to exposure to
the substances tested, because the effects observed in exposed organisms
differ from effects observed in control organisms, are atypical in view
of historical experience with the organism tested, or otherwise support
a reasonable inference of causation, and 30 days have passed from the
date the registrant first has the information.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]
Sec. 159.167 Discontinued studies.
The fact that a study has been discontinued before the planned
termination must be reported to EPA, with the reason for termination, if
submission of information concerning the study is, or would have been,
required under this part.
Sec. 159.170 Human epidemiological and exposure studies.
Information must be submitted which concerns any study that a person
described in Sec. 159.158(a) has concluded, or might reasonably
conclude, shows that a correlation may exist between exposure to a
pesticide and observed adverse effects in humans. Information must also
be submitted which concerns exposure monitoring studies that indicate
higher levels of risk or exposure than would be expected based on
previously available reports, data, or exposure estimates. Such
information must be submitted regardless of whether the registrant
considers any observed correlation or association to be significant.
Sec. 159.178 Information on pesticides in or on food, feed or water.
(a) Food and feed. Information must be submitted if it shows that
the pesticide is present in or on food or feed at a level in excess of
established levels, except that information on excess residues resulting
solely from studies conducted under authority of FIFRA section 5 or
under other controlled research studies conducted to test a pesticide
product need not be submitted, provided that the treated crop is not
marketed as a food or feed commodity. The information to be submitted is
the same as that required in Sec. 159.184(c)(1), (2), (3), and
(4)(iv)(E), (F), (G), and (H).
(b) Water. (1) Information must be submitted if it shows that a
pesticide is present above the water reference level in any of the
following instances:
(i) Waters of the United States, as defined in Sec. 122.2 of this
chapter, except paragraph (d) of Sec. 122.2.
(ii) Ground water.
(iii) Finished drinking water.
(2) If the lowest detectable amount of the pesticide is reported,
the detection limit must also be reported.
(3) Information need not be submitted regarding the detection of a
pesticide in waters of the United States or finished drinking water if
the pesticide is registered for use in finished drinking water or
surface water and the amount detected does not exceed the amounts
reported by a registrant in its application for registration, as
resulting in those waters from legal applications of the pesticide.
(4) Information need not be submitted concerning detections of
pesticides in waters of the United States, ground water or finished
drinking water if the substance detected is an inert ingredient, or a
metabolite, degradate, contaminant or impurity of
[[Page 138]]
a pesticide product, unless EPA has established or proposed a maximum
contaminant level (MCL) or health advisory level (HAL) for that
substance, or has estimated a health advisory level based on an
established reference dose (RfD) for that substance, and notified
registrants of that level.
(5) Information to be submitted is the same as that required in
Sec. 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]
Sec. 159.179 Metabolites, degradates, contaminants, and impurities.
(a) Metabolites and degradates. Information which shows the
existence of any metabolite or degradate of a pesticide product must be
submitted if either of the following conditions is met:
(1) The metabolite or degradate may occur or be present under
conditions of use of the pesticide product, and the existence of the
metabolite or degradate or the association of the metabolite or
degradate with the pesticide product has not been previously reported to
EPA.
(2) The metabolite or degradate has been previously reported, but it
is detected at levels higher than any previously reported; and either of
the following conditions is met:
(i) Any person described in Sec. 159.158(a) has concluded that the
metabolite or degradate may pose a toxicological or ecological risk
based on any one or more of the following:
(A) The physical or chemical properties of the metabolite or
degradate.
(B) Data regarding structurally analogous chemicals.
(C) Data regarding chemical reactivity of the metabolite or
degradate and structurally analogous substances.
(D) Data on the metabolite or degradate.
(ii) The registrant has concluded, or has been advised by any person
described in Sec. 159.158(a) that the metabolite or degradate, or
analogous chemicals, may have any experimentally determined half-life
greater than 3 weeks as shown from laboratory aerobic soil metabolism
studies or field dissipation studies, or may have any experimentally
determined resistance to hydrolytic degradation, or photolytic
degradation on soil or in water, under any conditions, resulting in
degradation of less than 10 percent in a 30-day period.
(b) Contaminants and impurities. The presence in any pesticide
product of a contaminant or impurity not previously identified by the
registrant as part of the pesticide product's approved composition must
be reported pursuant to this part if the contaminant or impurity is
present in the product in any of the following quantities:
(1) Quantities greater than 0.1 percent by weight (1,000 parts per
million).
(2) Quantities that EPA considers, and so informs registrants, to be
of toxicological significance.
(3) Quantities that the registrant considers to be of toxicological
significance.
(4) Quantities above a level for which the registrant has
information indicating that the presence of the contaminant or impurity
may pose a risk to health or the environment.
(5) Quantities that a person described in Sec. 159.158(a) has
informed the registrant is likely to be of toxicological significance.
[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]
Sec. 159.184 Toxic or adverse effect incident reports.
(a) General. Information about incidents affecting humans or other
non-target organisms must be submitted if the following three conditions
are met:
(1) The registrant is aware, or has been informed that a person or
non-target organism may have been exposed to a pesticide.
(2) The registrant is aware, or has been informed that the person or
non-target organism suffered a toxic or adverse effect, or may suffer a
delayed or chronic adverse effect in the future.
(3) The registrant has or could obtain information concerning where
the incident occurred, the pesticide or product involved, and the name
of a person to contact regarding the incident.
(b) Exceptions. Information regarding an incident need not be
submitted if any of the following conditions are met:
[[Page 139]]
(1) The registrant is aware of facts which clearly establish that
the reported toxic effect, or reported exposure, did not or will not
occur.
(2) The registrant has been notified in writing by the Agency that
the reporting requirement has been waived for this incident or category
of incidents, and the registrant has not been notified in writing by the
Agency that the waiver is rescinded.
(3) It concerns a toxic effect to non-target plants, which were at
the use site at the time the pesticide was applied, if the label
provides adequate notice of such a risk.
(4) It concerns non-lethal phytotoxicity to the treated crop if the
label provides an adequate notice of such a risk.
(5) It concerns a toxic effect to pests not specified on the label,
provided that such pests are similar to pests specified on the label.
(6) It concerns minor skin or eye irritation effects warned of on
the label of a product which is registered for use in residential use
sites, and the effects occurred as a result of use in a residential
site.
(c) Required information on individual incidents. To the extent that
the registrant has any of the information listed in paragraphs (c)(1)
through (c)(4) of this section, the registrant must supply the
information on each pesticide incident that meets the requirements
outlined in paragraph (a) of this section. If the registrant acquires
additional information concerning an incident previously reported to the
Agency under this part, such information shall be reported if it meets
the criteria set forth in paragraph (f) of this section. In the future,
the Agency may by notice specify a format for such submissions. The
Administrative, Pesticide, Circumstance and Exposure Type(s) of
information must be reported for individual incidents, except where the
provisions of paragraph (e) of this section allow for aggregated summary
forms of reporting, or if EPA in the future grants permission in writing
for alternative reporting formats. The registrant must also provide one
or more Exposure Type and Severity categories and their designations for
each incident as set forth in paragraph (c)(5) of this section,
depending on the applicability of the criteria listed below. The
criteria listed should be used in assigning a category. For example, an
incident which allegedly caused serious but non-fatal effects to human
beings and domestic animals might be designated ``H-B: D-B.'' When a
single incident involves multiple pesticides, the registrant need only
report on their specific product. However, if a single incident involves
more than one type of non-target organism--for example, both humans and
domestic animals are involved--all appropriate available information
dealing with each of the victims must also be reported. The
informational items below are grouped by sections for ease in reporting
pesticide incidents.
(1) Administrative. Pesticide incident reports must be submitted if
the registrant possesses or receives any of the following information,
and the incident meets the minimum requirements set forth in paragraph
(a) of this section:
(i) Name of reporter, address, and telephone number.
(ii) Name, address, and telephone number of contact person (if
different than reporter).
(iii) Incident report status (e.g., new or update); if update,
include the date of original submission.
(iv) Date registrant became aware of the incident.
(v) Date of incident (if appropriate, list start and end dates).
(vi) Location of incident (city, county and state).
(vii) Is incident part of a larger study.
(viii) Source if different from reporting registrant.
(2) Pesticide. Pesticide incident reports must be submitted for each
pesticide that may have contributed to the incident, if the registrant
possesses or receives any of the following information, and the incident
meets the minimum requirements set forth in paragraph (a) of this
section:
(i) Product name.
(ii) Active ingredient(s).
(iii) EPA Registration Number.
(iv) Diluted for use, or concentrate.
(v) Formulation, if known.
[[Page 140]]
(3) Circumstance. Pesticide incident reports must be submitted if
the registrant possesses or receives any of the following information,
and the incident meets the minimum requirements set forth in paragraph
(a) of this section:
(i) Evidence the label directions were not followed (e.g., yes, no,
unknown).
(ii) How exposed (e.g., spill, drift, equipment failure, container
failure, mislabeling, runoff, etc.).
(iii) Situation (e.g., household use, mixing/loading, application,
reentry, disposal, transportation, other (describe)).
(iv) Use site (e.g., home, yard, commercial turf, agricultural
(specify crop), industrial, building/office, school, nursery,
greenhouse, pond/lake/stream, well, forest/woods, other.
(v) Applicator certified (yes, no, unknown).
(vi) A brief description of the circumstances of the incident.
(4) Other incident specific information. Pesticide incident reports
must be submitted if the registrant possesses or receives any of the
following information, and the incident meets the minimum requirements
set forth in paragraph (a) of this section:
(i) If the incident involves humans:
(A) Route of exposure (skin, eye, respiratory, oral).
(B) List signs/symptoms/adverse effects.
(C) If laboratory tests were performed, list name of test(s) and
results.
(D) If available, submit laboratory report(s).
(E) Time between exposure and onset of symptoms.
(F) Was adverse effect the result of suicide/homicide or attempted
suicide/homicide.
(G) Type of medical care sought, (e.g., none, Poison Control Center,
hospital emergency department, hospital inpatient, private physician,
clinic, other).
(H) Demographics (sex, age, occupation).
(I) If female, pregnant?
(J) Exposure data: amount of pesticide; duration of exposure; weight
of victim.
(K) Was exposure occupational; days lost due to illness.
(L) Was protective clothing worn (specify).
(ii) If domestic animal:
(A) Type of animal (e.g., livestock, poultry, bird, fish, household
pet e.g., dog/cat etc.).
(B) List signs/symptoms/adverse effects.
(C) Breed/species (name and number affected, per adverse effect).
(D) Route of exposure (e.g., skin, eye, respiratory, oral).
(E) Time between exposure and onset of symptoms.
(F) If laboratory test(s) performed, list name of tests and results.
(G) If available, submit laboratory report(s).
(iii) If fish, wildlife, plants or other non-target organisms:
(A) List species affected, and number of individuals per species.
(B) List symptoms or adverse effects.
(C) Magnitude of the effect (e.g., miles of streams, square area of
terrestrial habitat).
(D) Pesticide application rate, intended use site (e.g., corn,
turf), and method of application.
(E) Description of the habitat and the circumstances under which the
incident occurred.
(F) If plant, type of plant life (i.e., crop, forest, orchard, home
garden, ornamental, forage).
(G) Formulation of pesticide if not indicated by brand name
(granular, flowable).
(H) Distance from treatment site.
(I) If laboratory test(s) performed, list name of test(s) and
results.
(J) If available, submit laboratory report(s).
(iv) If surface water:
(A) If raw water samples, water bodies sampled and approximate
locations in each water body.
(B) If raw water samples, proximity of sampling locations to
drinking water supply intakes and identities of systems supplied.
(C) If finished water samples, water supply systems sampled.
(D) If finished water samples, percent surface water source by
specific surface water sources to water supply system(s).
(E) Sample type (grab, composite).
(F) Sampling times/frequency.
[[Page 141]]
(G) Pesticides and degredates analyzed for, the detection limits,
and the amount detected.
(H) Method of analysis.
(v) If ground water:
(A) Pesticides and degredates analyzed for, the analytical method
used, the detection limits, and the amount detected.
(B) Sample date.
(C) Amount pesticide applied (lbs-ai/acre).
(D) Date of last application.
(E) Depth to water.
(F) Latitude/longitude.
(G) Soil series and texture (sand/silt/clay).
(H) Frequency of applications per year.
(I) Aquifer description (confined/unconfined).
(J) Method of application.
(K) Years pesticide used.
(L) Well use and well identifier.
(M) Screened interval.
(N) Annual cumulative rainfall (inches).
(O) Maximum rainfall and date.
(P) Cumulative irrigation (inches).
(Q) Hydrologic group.
(R) Hydraulic conductivity.
(S) pH.
(T) Organic matter or organic carbon (percent).
(vi) If property damage.
(A) Provide description.
(B) [Reserved]
(5) Exposure types and severity category designations--(i) Humans.
If an effect involves a human, provide the appropriate 2-letter exposure
types and severity categories and their designations, based upon the
following categories:
(A) H-A: If the person died.
(B) H-B: If the person alleged or exhibited symptoms which may have
been life-threatening, or resulted in adverse reproductive effects or in
residual disability.
(C) H-C: If the person alleged or exhibited symptoms more
pronounced, more prolonged or of a more systemic nature than minor
symptoms. Usually some form of treatment of the person would have been
Indicated. Symptoms were not life threatening and the person has
returned to his/her pre-exposure state of health with no additional
residual disability.
(D) H-D: If the person alleged or exhibited some symptoms, but they
were minimally traumatic. The symptoms resolved rapidly and usually
involve skin, eye or respiratory irritation.
(E) H-E: If symptoms are unknown, unspecified or are alleged to be
of a delayed or chronic nature that may appear in the future.
(ii) Domestic animals. If an effect involves a domestic animal,
provide the appropriate 2-letter notation based upon the following
categories:
(A) D-A: If the domestic animal died or was euthanized.
(B) D-B: If the domestic animal exhibited or was alleged to have
exhibited symptoms which may have been life-threatening or resulted in
residual disability.
(C) D-C: If the domestic animal exhibited or was alleged to have
exhibited symptoms which are more pronounced, more prolonged or of a
more systemic nature than minor symptoms. Usually some form of treatment
would have been indicated to treat the animal. Symptoms were not life
threatening and the animal has returned to its pre-exposure state of
health with no additional residual disability.
(D) D-D: If the domestic animal was alleged to have exhibited
symptoms, but they were minimally bothersome. The symptoms resolved
rapidly and usually involve skin, eye or respirator irritation.
(E) D-E: If symptoms are unknown or not specified.
(iii) Fish or wildlife. If an alleged effect involves fish or
wildlife, label the incident W-A if any of the following criteria are
met, or W-B if none of the criteria are met:
(A) Involves any incident caused by a pesticide currently in Formal
Review forecological concerns.
(B) Fish: Affected 1,000 or more individuals of a schooling species
or 50 or more individuals of a non-schooling species.
(C) Birds: Affected 200 or more individuals of a flocking species,
or 50 or moreindividuals of a songbird species, or 5 or more individuals
of a predatory species.
[[Page 142]]
(D) Mammals, reptiles, amphibians: Affected 50 or more individuals
of a relatively common or herding species or 5 or more individuals of a
rare or solitary species.
(E) Involves effects to, or illegal pesticide treatment (misuse) of
a substantial tract of habitat (greater than or equal to 10 acres,
terrestrial or aquatic).
(F) Involves a major spill or discharge (greater than or equal to
5,000 gallons) of a pesticide.
(G) Involves adverse effects caused by a pesticide, to federally
listed endangered or threatened species.
(iv) Plants. If an alleged effect involves damage to plants, label
the incident P-A if the following criterion is met, or P-B if the
criterion is not met:
(A) The effect is alleged to have occurred on more than 45 percent
of the acreage exposed to the pesticide.
(B) [Reserved]
(v) Other non-target organisms. If an alleged effect involves damage
to non-target organisms other than fish, wildlife or plants (for
example, beneficial insects), label the incident ONT.
(vi) Water contamination. If a pesticide is alleged to have been
detected in groundwater, surface water or finished drinking water, label
the incident in accordance with the following criteria:
(A) G-A: If the pesticide was detected at levels greater than the
maximum contaminant level (MCL) or health advisory level (HAL) or an
applicable criterion for ambient water quality.
(B) G-B: If the pesticide was detected at levels greater than 10
percent of the MCL, HAL or a criterion for ambient water quality but
does not exceed the MCL or other applicable level.
(C) G-C: If the pesticide was detected at levels less than 10
percent of the MCL, HAL, or other applicable level, or there is no
established level of concern.
(vii) Property damage. If an incident involves alleged property
damage the applicable term(s) shall be included along with any other
applicable effect category label; for example, ``H-B: property damage.''
Label the incident in accordance with the following criteria:
(A) PD-A: The product is alleged to have caused damage in a manner
that could have caused direct human injury, such as fire or explosion.
(B) PD-B: The product is alleged to have caused damage in excess of
$5,000.
(C) PD-C: Any allegation of property damage that does not meet the
criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including
cases in which the level of damages is not specified.
(d) Time requirements for submitting incident information.
Information concerning incidents reportable under this section must be
submitted within the time frames listed for different exposure and
severity categories, as follows:
(1) For allegations involving human fatality (H-A), registrants must
submit the required information, to the extent it is available, no later
than 15 days after learning of an allegation.
(2) Information concerning incidents which meet the criteria for the
following exposure and severity category labels described in paragraph
(c)(5) of this section, reports of detections of pesticides in water,
and efficacy failure incidents may be described in Sec. 159.188(a)(1)
and (b)(1), may be accumulated for a 30-day period, and submitted to the
Agency within 30 days after the end of each 30-day accumulation period
for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A;
Property Damage, PD-A.
(3) Incidents or reports of detections of pesticides in water
meeting all other exposure and severity label categories, information
may be accumulated by registrants for 90 days and submitted within 60
days after the end of each 90-day accumulation period.
(e) Aggregated reports. For incidents that are reportable under the
schedule requirements of paragraph (d)(3) of this section, in lieu of
individual reports containing the information listed in paragraphs
(c)(1) through (c)(4) of this section, registrants must provide an
aggregated report listing:
(1) The time period covered by the report.
(2) For each exposure and severity label category, a count of the
number of incidents, listed by product registration number (if known) or
active ingredient.
(3) A count of domestic animal incidents in categories, other than
D-A or
[[Page 143]]
D-B, which can be added together and reported as a single number.
(f) Reporting additional information. If, after the submission of an
incident report to the Agency, a registrant acquires additional
information concerning that incident, the information should be
submitted within the same time frame as applied to the original incident
report, if any of the following conditions apply:
(1) The information concerns an alleged human fatality (H-A), and
the information consists of any of the elements listed in paragraphs
(c)(1) through (c)(4) of this section.
(2) The information concerns an incident originally reported as
alleging a major human illness or injury (H-B), or fatality to a
domestic animal (D-A), or wildlife (W-A), and the additional information
consists of pesticide or circumstance information listed in paragraphs
(c)(2) or (c)(3) of this section, or is a laboratory report concerning
persons or animals involved in the incident.
(3) The information concerns any incident not originally reported
with one of the exposure and severity labels H-A, or H-B for human
incidents, or at the ``A'' level of severity for any other exposure or
incident type, and the new information would result in labeling the
incident H-A or H-B for a human incident, or at the ``A'' level of
severity for any other exposure or incident type listed in paragraph
(c)(5) of this section.
[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]
Sec. 159.188 Failure of performance information.
(a) Microorganisms that pose a risk to human health. Information
must be submitted which concerns either incidents described in paragraph
(a)(1) of this section or a study described in paragraph (a)(2) of this
section:
(1) Information which concerns an incident which meets all of the
following conditions:
(i) The registrant has been informed that a pesticide product may
not have performed as claimed against target microorganisms.
(ii) The possible failures of the pesticide to perform as claimed
involved the use against microorganisms which may pose a risk to human
health.
(iii) The pesticide product's use site is other than residential.
(iv) The registrant has or could obtain information concerning where
the incident occurred, the pesticide or product involved, and the name
of a person to contact regarding the incident.
(2) A study which indicates that the pesticide may not perform in
accordance with one or more claims made by the registrant regarding uses
intended for control of microorganisms that may pose a risk to human
health, including any of the public health antimicrobials identified in
part 158 of this chapter.
(b) Animals that pose a risk to human health. For the purposes of
this section, any animal (including insects) poses a risk to human
health if it may cause disease in humans, either directly or as a
disease vector; produce toxins that are harmful to humans; or cause
direct physical harm to humans. Information must be submitted which
concerns either incidents described in paragraph (b)(1) of this section
or a study described in paragraph (b)(2) of this section.
(1) Information which concerns an incident which meets all of the
following conditions:
(i) The registrant has been informed by municipal, State, or Federal
public health officials that a pesticide product may not have performed
as claimed against target animals.
(ii) The possible failures of the pesticide to perform as claimed
involved the use against animals that pose a risk to human health.
(iii) The registrant has or could obtain information concerning
where the incident occurred, the pesticide or product involved, and the
name of a person to contact regarding the incident.
(2) A study which indicates that the pesticide may not perform in
accordance with one or more claims by the registrant regarding uses
intended for control of animals that pose a risk to human health,
including any of the public health pesticides identified in part 158 of
this chapter.
[[Page 144]]
(c) Development of pesticide resistance. Information must be
submitted concerning substantiation of any incident of a pest having
developed resistance to any pesticide (both public health and non-public
health) that occurred under conditions of use, application rates and
methods specified on the label if either of the following conditions is
met:
(1) The survival of the suspected pesticide-resistant pest was
significantly higher than that of a known susceptible pest when both the
suspected resistant and susceptible pests were treated with the
pesticide under controlled conditions.
(2) Biochemical tests or DNA sequencing indicate that the pest is
resistant to the pesticide.
Sec. 159.195 Reporting of other information.
(a) The registrant shall submit to the Administrator information
other than that described in Sec. Sec. 159.165 through 159.188 if the
registrant knows, or reasonably should know, that if the information
should prove to be correct, EPA might regard the information alone or in
conjunction with other information about the pesticide as raising
concerns about the continued registration of a product or about the
appropriate terms and conditions of registration of a product. Examples
of the types of information which must be provided if not already
reportable under some other provision of this Part include but are not
limited to information showing:
(1) Previously unknown or unexpected bioaccumulation of a pesticide
by various life forms.
(2) Greater than anticipated drift of pesticides to non-target
areas.
(3) Use of a pesticide may pose any greater risk than previously
believed or reported to the Agency.
(4) Use of a pesticide promotes or creates secondary pest
infestations.
(5) Any information which might tend to invalidate a study submitted
to the Agency to support a pesticide registration.
(b) A registrant is not obligated under paragraph (a) of this
section to provide information to the Administrator if the registrant is
aware of facts which establish that otherwise reportable information is
not correct.
(c) The registrant shall submit to the Administrator information
other than that described in Sec. Sec. 159.165 through 159.188 if the
registrant has been informed by EPA that such additional information has
the potential to raise questions about the continued registration of a
product or about the appropriate terms and conditions of registration of
a product.
[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]
PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents
Subpart A_General Provisions
Sec.
160.1 Scope.
160.3 Definitions.
160.10 Applicability to studies performed under grants and contracts.
160.12 Statement of compliance or non-compliance.
160.15 Inspection of a testing facility.
160.17 Effects of non-compliance.
Subpart B_Organization and Personnel
160.29 Personnel.
160.31 Testing facility management.
160.33 Study director.
160.35 Quality assurance unit.
Subpart C_Facilities
160.41 General.
160.43 Test system care facilities.
160.45 Test system supply facilities.
160.47 Facilities for handling test, control, and reference substances.
160.49 Laboratory operation areas.
160.51 Specimen and data storage facilities.
Subpart D_Equipment
160.61 Equipment design.
160.63 Maintenance and calibration of equipment.
Subpart E_Testing Facilities Operation
160.81 Standard operating procedures.
160.83 Reagents and solutions.
160.90 Animal and other test system care.
Subpart F_Test, Control, and Reference Substances
160.105 Test, control, and reference substance characterization.
[[Page 145]]
160.107 Test, control, and reference substance handling.
160.113 Mixtures of substances with carriers.
Subpart G_Protocol for and Conduct of a Study
160.120 Protocol.
160.130 Conduct of a study.
160.135 Physical and chemical characterization studies.
Subparts H-I [Reserved]
Subpart J_Records and Reports
160.185 Reporting of study results.
160.190 Storage and retrieval of records and data.
160.195 Retention of records.
Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w;
21 U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.
Source: 54 FR 34067, Aug. 17, 1989, unless otherwise noted.
Subpart A_General Provisions
Sec. 160.1 Scope.
(a) This part prescribes good laboratory practices for conducting
studies that support or are intended to support applications for
research or marketing permits for pesticide products regulated by the
EPA. This part is intended to assure the quality and integrity of data
submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7
U.S.C. 136a, 136c, 136f, 136q and 136v(c)) and sections 408 and 409 of
the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a, 348).
(b) This part applies to any study described by paragraph (a) of
this section which any person conducts, initiates, or supports on or
after October 16, 1989.
Sec. 160.3 Definitions.
As used in this part the following terms shall have the meanings
specified:
Application for research or marketing permit includes:
(1) An application for registration, amended registration, or
reregistration of a pesticide product under FIFRA sections 3, 4 or
24(c).
(2) An application for an experimental use permit under FIFRA
section 5.
(3) An application for an exemption under FIFRA section 18.
(4) A petition or other request for establishment or modification of
a tolerance, for an exemption for the need for a tolerance, or for other
clearance under FFDCA section 408.
(5) A petition or other request for establishment or modification of
a food additive regulation or other clearance by EPA under FFDCA section
409.
(6) A submission of data in response to a notice issued by EPA under
FIFRA section 3(c)(2)(B).
(7) Any other application, petition, or submission sent to EPA
intended to persuade EPA to grant, modify, or leave unmodified a
registration or other approval required as a condition of sale or
distribution of a pesticide.
Batch means a specific quantity or lot of a test, control, or
reference substance that has been characterized according to Sec.
160.105(a).
Carrier means any material, including but not limited to feed,
water, soil, nutrient media, with which the test substance is combined
for administration to a test system.
Control substance means any chemical substance or mixture, or any
other material other than a test substance, feed, or water, that is
administered to the test system in the course of a study for the purpose
of establishing a basis for comparison with the test substance for known
chemical or biological measurements.
EPA means the U.S. Environmental Protection Agency.
Experimental start date means the first date the test substance is
applied to the test system.
Experimental termination date means the last date on which data are
collected directly from the study.
FDA means the U.S. Food and Drug Administration.
FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21
U.S.C. 321 et seq).
FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act
as amended (7 U.S.C. 136 et seq).
[[Page 146]]
Person includes an individual, partnership, corporation,
association, scientific or academic establishment, government agency, or
organizational unit thereof, and any other legal entity.
Quality assurance unit means any person or organizational element,
except the study director, designated by testing facility management to
perform the duties relating to quality assurance of the studies.
Raw data means any laboratory worksheets, records, memoranda, notes,
or exact copies thereof, that are the result of original observations
and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact
transcripts of raw data have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original
source as raw data. ``Raw data'' may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated instruments.
Reference substance means any chemical substance or mixture, or
analytical standard, or material other than a test substance, feed, or
water, that is administered to or used in analyzing the test system in
the course of a study for the purposes of establishing a basis for
comparison with the test substance for known chemical or biological
measurements.
Specimens means any material derived from a test system for
examination or analysis.
Sponsor means:
(1) A person who initiates and supports, by provision of financial
or other resources, a study;
(2) A person who submits a study to the EPA in support of an
application for a research or marketing permit; or
(3) A testing facility, if it both initiates and actually conducts
the study.
Study means any experiment at one or more test sites, in which a
test substance is studied in a test system under laboratory conditions
or in the environment to determine or help predict its effects,
metabolism, product performance (efficacy studies only as required by 40
CFR 158.640), environmental and chemical fate, persistence and residue,
or other characteristics in humans, other living organisms, or media.
The term ``study'' does not include basic exploratory studies carried
out to determine whether a test substance or a test method has any
potential utility.
Study completion date means the date the final report is signed by
the study director.
Study director means the individual responsible for the overall
conduct of a study.
Study initiation date means the date the protocol is signed by the
study director.
Test substance means a substance or mixture administered or added to
a test system in a study, which substance or mixture:
(1) Is the subject of an application for a research or marketing
permit supported by the study, or is the contemplated subject of such an
application; or
(2) Is an ingredient, impurity, degradation product, metabolite, or
radioactive isotope of a substance described by paragraph (1) of this
definition, or some other substance related to a substance described by
that paragraph, which is used in the study to assist in characterizing
the toxicity, metabolism, or other characteristics of a substance
described by that paragraph.
Test system means any animal, plant, microorganism, chemical or
physical matrix, including but not limited to soil or water, or subparts
thereof, to which the test, control, or reference substance is
administered or added for study. ``Test system'' also includes
appropriate groups or components of the system not treated with the
test, control, or reference substance.
Testing facility means a person who actually conducts a study, i.e.,
actually uses the test substance in a test system. ``Testing facility''
encompasses only those operational units that are being or have been
used to conduct studies.
Vehicle means any agent which facilitates the mixture, dispersion,
or solubilization of a test substance with a carrier.
[[Page 147]]
Sec. 160.10 Applicability to studies performed under grants and contracts.
When a sponsor or other person utilizes the services of a consulting
laboratory, contractor, or grantee to perform all or a part of a study
to which this part applies, it shall notify the consulting laboratory,
contractor, or grantee that the service is, or is part of, a study that
must be conducted in compliance with the provisions of this part.
Sec. 160.12 Statement of compliance or non-compliance.
Any person who submits to EPA an application for a research or
marketing permit and who, in connection with the application, submits
data from a study to which this part applies shall include in the
application a true and correct statement, signed by the applicant, the
sponsor, and the study director, of one of the following types:
(a) A statement that the study was conducted in accordance with this
part; or
(b) A statement describing in detail all differences between the
practices used in the study and those required by this part; or
(c) A statement that the person was not a sponsor of the study, did
not conduct the study, and does not know whether the study was conducted
in accordance with this part.
Sec. 160.15 Inspection of a testing facility.
(a) A testing facility shall permit an authorized employee or duly
designated representative of EPA or FDA, at reasonable times and in a
reasonable manner, to inspect the facility and to inspect (and in the
case of records also to copy) all records and specimens required to be
maintained regarding studies to which this part applies. The records
inspection and copying requirements should not apply to quality
assurance unit records of findings and problems, or to actions
recommended and taken, except that EPA may seek production of these
records in litigation or formal adjudicatory hearings.
(b) EPA will not consider reliable for purposes of supporting an
application for a research or marketing permit any data developed by a
testing facility or sponsor that refuses to permit inspection in
accordance with this part. The determination that a study will not be
considered in support of an application for a research or marketing
permit does not, however, relieve the applicant for such a permit of any
obligation under any applicable statute or regulation to submit the
results of the study to EPA.
Sec. 160.17 Effects of non-compliance.
(a) EPA may refuse to consider reliable for purposes of supporting
an application for a research or marketing permit any data from a study
which was not conducted in accordance with this part.
(b) Submission of a statement required by Sec. 160.12 which is
false may form the basis for cancellation, suspension, or modification
of the research or marketing permit, or denial or disapproval of an
application for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or
FFDCA section 406 or 409, or for criminal prosecution under 18 U.S.C. 2
or 1001 or FIFRA section 14, or for imposition of civil penalties under
FIFRA section 14.
Subpart B_Organization and Personnel
Sec. 160.29 Personnel.
(a) Each individual engaged in the conduct of or responsible for the
supervision of a study shall have education, training, and experience,
or combination thereof, to enable that individual to perform the
assigned functions.
(b) Each testing facility shall maintain a current summary of
training and experience and job description for each individual engaged
in or supervising the conduct of a study.
(c) There shall be a sufficient number of personnel for the timely
and proper conduct of the study according to the protocol.
(d) Personnel shall take necessary personal sanitation and health
precautions designed to avoid contamination of test, control, and
reference substances and test systems.
(e) Personnel engaged in a study shall wear clothing appropriate for
the duties they perform. Such clothing shall be changed as often as
necessary
[[Page 148]]
to prevent microbiological, radiological, or chemical contamination of
test systems and test, control, and reference substances.
(f) Any individual found at any time to have an illness that may
adversely affect the quality and integrity of the study shall be
excluded from direct contact with test systems, and test, control, and
reference substances, and any other operation or function that may
adversely affect the study until the condition is corrected. All
personnel shall be instructed to report to their immediate supervisors
any health or medical conditions that may reasonably be considered to
have an adverse effect on a study.
Sec. 160.31 Testing facility management.
For each study, testing facility management shall:
(a) Designate a study director as described in Sec. 160.33 before
the study is initiated.
(b) Replace the study director promptly if it becomes necessary to
do so during the conduct of a study.
(c) Assure that there is a quality assurance unit as described in
Sec. 160.35.
(d) Assure that test, control, and reference substances or mixtures
have been appropriately tested for identity, strength, purity,
stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment,
materials and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are
to perform.
(g) Assure that any deviations from these regulations reported by
the quality assurance unit are communicated to the study director and
corrective actions are taken and documented.
Sec. 160.33 Study director.
For each study, a scientist or other professional of appropriate
education, training, and experience, or combination thereof, shall be
identified as the study director. The study director has overall
responsibility for the technical conduct of the study, as well as for
the interpretation, analysis, documentation, and reporting of results,
and represents the single point of study control. The study director
shall assure that:
(a) The protocol, including any change, is approved as provided by
Sec. 160.120 and is followed.
(b) All experimental data, including observations of unanticipated
responses of the test system are accurately recorded and verified.
(c) Unforseen circumstances that may affect the quality and
integrity of the study are noted when they occur, and corrective action
is taken and documented.
(d) Test systems are as specified in the protocol.
(e) All applicable good laboratory practice regulations are
followed.
(f) All raw data, documentation, protocols, specimens, and final
reports are transferred to the archives during or at the close of the
study.
Sec. 160.35 Quality assurance unit.
(a) A testing facility shall have a quality assurance unit which
shall be responsible for monitoring each study to assure management that
the facilities, equipment, personnel, methods, practices, records, and
controls are in conformance with the regulations in this part. For any
given study, the quality assurance unit shall be entirely separate from
and independent of the personnel engaged in the direction and conduct of
that study. The quality assurance unit shall conduct inspections and
maintain records appropriate to the study.
(b) The quality assurance unit shall:
(1) Maintain a copy of a master schedule sheet of all studies
conducted at the testing facility indexed by test substance, and
containing the test system, nature of study, date study was initiated,
current status of each study, identity of the sponsor, and name of the
study director.
(2) Maintain copies of all protocols pertaining to all studies for
which the unit is responsible.
(3) Inspect each study at intervals adequate to ensure the integrity
of the study and maintain written and properly signed records of each
periodic inspection showing the date of the inspection, the study
inspected, the
[[Page 149]]
phase or segment of the study inspected, the person performing the
inspection, findings and problems, action recommended and taken to
resolve existing problems, and any scheduled date for reinspection. Any
problems which are likely to affect study integrity found during the
course of an inspection shall be brought to the attention of the study
director and management immediately.
(4) Periodically submit to management and the study director written
status reports on each study, noting any problems and the corrective
actions taken.
(5) Determine that no deviations from approved protocols or standard
operating procedures were made without proper authorization and
documentation.
(6) Review the final study report to assure that such report
accurately describes the methods and standard operating procedures, and
that the reported results accurately reflect the raw data of the study.
(7) Prepare and sign a statement to be included with the final study
report which shall specify the dates inspections were made and findings
reported to management and to the study director.
(c) The responsibilities and procedures applicable to the quality
assurance unit, the records maintained by the quality assurance unit,
and the method of indexing such records shall be in writing and shall be
maintained. These items including inspection dates, the study inspected,
the phase or segment of the study inspected, and the name of the
individual performing the inspection shall be made available for
inspection to authorized employees or duly designated representatives of
EPA or FDA.
(d) An authorized employee or a duly designated representative of
EPA or FDA shall have access to the written procedures established for
the inspection and may request testing facility management to certify
that inspections are being implemented, performed, documented, and
followed up in accordance with this paragraph.
Subpart C_Facilities
Sec. 160.41 General.
Each testing facility shall be of suitable size and construction to
facilitate the proper conduct of studies. Testing facilities which are
not located within an indoor controlled environment shall be of suitable
location to facilitate the proper conduct of studies. Testing facilities
shall be designed so that there is a degree of separation that will
prevent any function or activity from having an adverse effect on the
study.