[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2009 Edition]
[From the U.S. Government Printing Office]



[[Page i]]



          40


          Parts 150 to 189

                         Revised as of July 1, 2009


          Protection of Environment




________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of July 1, 2009
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 40:
          Chapter I--Environmental Protection Agency 
          (Continued)                                                3
  Finding Aids:
      Table of CFR Titles and Chapters........................     701
      Alphabetical List of Agencies Appearing in the CFR......     721
      List of CFR Sections Affected...........................     731

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 40 CFR 150.17 refers 
                       to title 40, part 150, 
                       section 17.

                     ----------------------------

[[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

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, July 1, 2009), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
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Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
states a date certain for expiration, an appropriate note will be 
inserted following the text.

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 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
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 eleven separate 
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Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
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to materials already published elsewhere. For an incorporation to be 
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effect of incorporation by reference is that the material is treated as 
if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
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.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed 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

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separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
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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

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in the Code of Federal Regulations.

INQUIRIES

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    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    July 1, 2009.







[[Page ix]]



                               THIS TITLE

    Title 40--Protection of Environment is composed of thirty-two 
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 
of part 52), parts 53-59, part 60 (60.1-end of part 60, sections), part 
60 (Appendices), parts 61-62, part 63 (63.1-63.599), part 63 (63.600-
63.1199), part 63 (63.1200-63.1439), part 63 (63.1440-63.6175), part 63 
(63.6580-63.8830), part 63 (63.8980-end of part 63) parts 64-71, parts 
72-80, parts 81-84, part 85-Sec. 86.599-99, part 86 (86.600-1-end of 
part 86), 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, parts 790-999, and part 1000 to end. 
The contents of these volumes represent all current regulations codified 
under this title of the CFR as of July 1, 2009.

    Chapter I--Environmental Protection Agency appears in all thirty-two 
volumes. Regulations issued by the Council on Environmental Quality, 
including an Index to Parts 1500 through 1508, appear in the volume 
containing part 1000 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 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                   TITLE 40--PROTECTION OF ENVIRONMENT




                  (This book contains parts 150 to 189)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Environmental Protection Agency (Continued)......         150

[[Page 3]]



         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)




  --------------------------------------------------------------------


  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             General.....................................           5
151

[Reserved]

152             Pesticide registration and classification 
                    procedures..............................           5
153             Registration policies and interpretations...          44
154             Special review procedures...................          45
155             Registration standards and registration 
                    review..................................          53
156             Labeling requirements for pesticides and 
                    devices.................................          61
157             Packaging requirements for pesticides and 
                    devices.................................          83
158             Data requirements for pesticides............          88
159             Statements of policies and interpretations..         167
160             Good laboratory practice standards..........         181
161             Data requirements for registration of 
                    antimicrobial pesticides................         193
162             State registration of pesticide products....         233
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........         241
165             Pesticide management and disposal...........         259
166             Exemption of Federal and State agencies for 
                    use of pesticides under emergency 
                    conditions..............................         285
167             Registration of pesticide and active 
                    ingredient producing establishments, 
                    submission of pesticide reports.........         295
168             Statements of enforcement policies and 
                    interpretations.........................         298
169             Books and records of pesticide production 
                    and distribution........................         308

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170             Worker protection standard..................         311
171             Certification of pesticide applicators......         339
172             Experimental use permits....................         355
173             Procedures governing the rescission of State 
                    primary enforcement responsibility for 
                    pesticide use violations................         371
174             Procedures and requirements for plant-
                    incorporated protectants................         374
176             Time-limited tolerances for emergency 
                    exemptions..............................         383
178             Objections and requests for hearings........         384
179             Formal evidentiary public hearing...........         388
180             Tolerances and exemptions for pesticide 
                    chemical residues in food...............         400
181-189

[Reserved]

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                     SUBCHAPTER E_PESTICIDE PROGRAMS





PART 150_GENERAL--Table of Contents




    Authority: Reorganization Plan No. 3 of 1970 (5 U.S.C. App.).



Sec. 150.17  Addresses for applications and correspondence.

    The official addresses for all submissions directed to the Office of 
Pesticide Programs (OPP) of the Environmental Protection Agency are as 
follows:
    (a) United States Postal Service mailing address. Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington DC 20460-0001.
    (b) Hand/courier delivery address. Office of Pesticide Programs, 
Environmental Protection Agency, 2777 S. Crystal Dr., Arlington, VA 
22202-4501.
    (c) OPP Regulatory Public Docket address. OPP Regulatory Public 
Docket is physically located in Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202-4501. This is not a 
mailing address.

[71 FR 35545, June 21, 2006]

                           PART 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 intended 
          for a pesticidal purpose.
152.15 Pesticide products required to be registered.

                          Subpart B_Exemptions

152.20 Exemptions for pesticides adequately 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.

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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.
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.

    (a) Part 152 sets forth procedures, requirements and criteria 
concerning the registration of pesticide products under FIFRA section 3, 
including plant-incorporated protectants (PIPs). Unless specifically 
superseded by part 174, the regulations in part 152 apply to PIPs.
    (b) Part 152 also describes associated regulatory activities 
affecting registration, as described in this paragraph.
    (1) Data compensation and exclusive use of data in support of 
registration. Refer to subpart E of this part.
    (2) Rights and obligations of registrants. Refer to subpart G of 
this part.
    (3) Classification of pesticide uses. Refer to subpart I of this 
part.
    (4) Fees. Refer to subpart U of this part.
    (5) Requirements pertaining to pesticide devices. Refer to subpart Z 
of this part.

[73 FR 75594, Dec. 12, 2008]



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

[[Page 7]]

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 or amended 
registration 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 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.
    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 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.
    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.

[[Page 8]]

    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
    (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.
    Released for shipment. A product becomes released for shipment when 
the producer has packaged and labeled it in the manner in which it will 
be distributed or sold, or has stored it in an area where finished 
products are ordinarily held for shipment. Products stored in an area 
where finished products are ordinarily held for shipment, but which are 
not intended to be released for shipment must be physically separated 
and marked as not yet released for shipment. Once a product becomes 
released for shipment, the product remains in the condition of being 
released for shipment unless subsequent activities, such as relabeling 
or repackaging, constitute production.
    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; 73 
FR 64224, Oct. 29, 2008; 73 FR 75594, Dec. 12, 2008]



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 microorganism, 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.

[[Page 9]]

    (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'' are not 
excluded and are jointly regulated by EPA and FDA.
    (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

[[Page 10]]

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 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, as amended at 73 FR 75594, Dec. 12, 2008]



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 
intended for a pesticidal purpose.

    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):

[[Page 11]]

    (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 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 adequately 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) A eucaryotic microorganism including, but not limited to, 
protozoa, algae and fungi;
    (ii) A procaryotic microorganism including, but not limited to, 
Eubacteria and Archaebacteria; or
    (iii) A parasitically-replicating microscopic element, including, 
but not limited to, 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; 72 FR 61027, Oct. 26, 2007]



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 ingredient(s).
    (1) For the purposes of this paragraph, a pheromone is a compound 
produced by an arthropod which, alone or

[[Page 12]]

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 
compound 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 pheromone is not 
identical.
    (3) When a compound possesses many characteristics of a pheromone 
but 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 
(f)(1) of this section may only include inert ingredients listed in the 
most current List 4A. This list is updated periodically. The most 
current list may be obtained by contacting the Registration

[[Page 13]]

Division at the appropriate address as set forth in 40 CFR 150.17(a) or 
(b).
    (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.
    (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; 71 FR 35545, June 21, 
2006]



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.

[[Page 14]]



                    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.



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. 158.355 of this 
chapter 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.

[53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]



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]

[[Page 15]]



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.
    (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

[[Page 16]]

results of the studies. The list of data submitted may be the same as 
the list required by Sec. 158.32 or Sec. 161.32, as applicable, of 
this chapter. The summary must state that it 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.
    (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)(F) 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 or part 
161 of this chapter, as applicable, 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 158.32 of this chapter, with respect to format of data 
submission.
    (ii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made.
    (iii) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects.
    (iv) Section 160.12 of this chapter, with respect to a statement 
whether studies were conducted in accordance with 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. (1) 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 chemical 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 
or exemption from the requirement of a tolerance issued under section 
408 of the Federal Food, Drug and Cosmetic Act (FFDCA).
    (2) If such residues have not been authorized, the application must 
be accompanied by a petition for establishment of appropriate tolerances 
or exemptions from the requirement of a tolerance, in accordance with 
part 180 of this chapter.
    (j) Fees. (1) The applicant shall identify the appropriate fee 
category in the schedule provided for by FIFRA sec. 33,

[[Page 17]]

and shall submit the fee for that category as prescribed by the latest 
EPA notice of section 33 fees.
    (2) If FIFRA sec. 33 is not in effect, the applicant shall submit 
any fees required by subpart U of this part, if applicable.

[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 
FR 32096, June 19, 1995; 72 FR 61027, Oct, 26 2007; 73 FR 75594, Dec. 
12, 2008]



Sec. 152.55  Where to send applications and correspondence.

    Applications and correspondence relating to registration should be 
sent to the Office of Pesticide Programs' Document Processing Desk at 
the appropriate address as set forth in 40 CFR 150.17(a) or (b).

[71 FR 35545, June 21, 2006]

Subpart D [Reserved]



  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 describes the information that an applicant must 
submit with his application for registration or amended registration to 
comply (and for the Agency to determine compliance) with the provisions 
of FIFRA sec. 3(c)(1)(F). 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.

[73 FR 75594, Dec. 12, 2008]



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;

[[Page 18]]

    (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;
    (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:
    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.
    Data Submitters List means the current Agency list, entitled 
``Pesticide Data Submitters by Chemical,'' of persons who have submitted 
data to the Agency.
    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.
    Original data submitter means the person who possesses all rights to 
exclusive use or compensation under FIFRA section 3(c)(1)(F) 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)(F) have been transferred, or the authorized 
representative of a group of joint data developers.
    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.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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.

[[Page 19]]



Sec. 152.85  Formulators' exemption.

    (a) Statutory provision. FIFRA section 3(c)(2)(D) excuses an 
applicant from the requirement to submit or cite data pertaining to any 
pesticide contained in his product that is derived solely from one or 
more EPA-registered products which the applicant purchases from another 
person. This provision is commonly referred to as the formulators' 
exemption.
    (b) Applicability of the formulators' exemption. (1) The 
formulators' exemption applies only to data concerning the purchased 
product or its ingredients. These data may include, but are not limited 
to, product chemistry, toxicology, residue chemistry, exposure, 
environmental fate, and ecological effects.
    (2) The data to which the formulators' exemption applies usually 
will concern the safety of one or more of the product's active 
ingredients, specifically, those active ingredients which are contained 
in the purchased product. In general, data for which the required test 
substance is the technical grade of the active ingredient, the pure 
active ingredient, the radiolabeled pure active ingredient, or a typical 
end-use product are eligible for the formulators' exemption.
    (3) The formulators' exemption generally does not apply to data on 
the applicant's product itself, including the safety or efficacy of the 
product, unless the composition of the product is identical to the 
purchased product. In general, data for which the required test 
substance is the product proposed for registration are not eligible for 
the formulators' exemption.
    (c) Limitation of the formulators' exemption. EPA interprets FIFRA 
section 3(c)(2)(D) as allowing an applicant to use the formulators' 
exemption with respect to data concerning an ingredient of his product 
only if:
    (1) The application indicates that the ingredient's presence in the 
product is attributable solely to the purchase from another person of an 
identified, registered product containing that ingredient and the use of 
the purchased product in formulating the 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 
labeled for any use for which the applicant's product will be labeled; 
or
    (3) The purchased product is a registered end-use product labeled 
for each use for which the applicant's product will be labeled.
    (d) Claiming eligibility for the exemption. (1) 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 requirement 
pertaining to 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):
    (i) Identification of the applicant, and of the product by EPA 
registration number or file symbol.
    (ii) 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.
    (iii) A statement that the listed ingredients meet the requirements 
for the formulators' exemption.
    (iv) A statement that the applicant has submitted (either previously 
or with the current application) a complete, accurate and current 
Confidential Statement of Formula.
    (v) The name, title and signature of the applicant or his authorized 
representative and the date of signature.
    (2) 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.
    (e) Approval of registration. Notwithstanding FIFRA section 
3(c)(2)(D), EPA will not approve an application unless there are 
available to EPA for its review all data that are necessary to make the 
required risk/benefit finding under FIFRA section 3(c)(5) or section 
3(c)(7).

[72 FR 61027, Oct. 26, 2007]



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

[[Page 20]]

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)(F) 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)(F) 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)(F) 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.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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.

[[Page 21]]

    (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 or part 
161, as applicable. 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.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]



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 or 40 CFR 161.45.
    (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.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]



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 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

[[Page 22]]

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)(F)(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)(F);
    (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 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).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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)(F).

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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

[[Page 23]]

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)(F);
    (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.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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 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

[[Page 24]]

    (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 requirement(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 or part 161, as 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.

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]



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)(F) may transfer such rights to another person in 
accordance with this section.
    (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;

[[Page 25]]

    (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)(F), unless a new transfer agreement 
is submitted to the Agency.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



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 rights accorded him under FIFRA section 
3(c)(1)(F). 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.

[[Page 26]]

    (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)(F)(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)(F), 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)(F) or of this 
subpart, in the manner described by the petitioner. A decision following 
a hearing shall be final.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]



                 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 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

[[Page 27]]

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, or part 161 of this chapter, as 
applicable, and not submitted in accordance with the requirements for 
format, claims of confidential business information, or flagging).

[72 FR 61028, Oct. 26, 2007



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 
or 161.34 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.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007]



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 subject to specific timeframes under the fee 
schedule established by FIFRA section 33 will be reviewed within the 
timeframes established for the application or action type.

[73 FR 75595, Dec. 12, 2008]



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

[[Page 28]]

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 for the product by part 158 or part 161 of 
this chapter, as applicable.
    (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, 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.

[53 FR 15980, May 4, 1988, as amended at 72 FR 61028, Oct. 26, 2007; 73 
FR 75595, Dec. 12, 2008]



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
    (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

[[Page 29]]

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 
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.

[[Page 30]]

    (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)(F)(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.

[53 FR 15980, May 4, 1988, as amended at 73 FR 75595, Dec. 12, 2008]



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.



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.

[[Page 31]]

    (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, the registrant shall, in accordance with FIFRA section 
6(a)(2) and the requirements of part 159, subpart D of this chapter, 
provide such information to the Agency, clearly identified as FIFRA 
6(a)(2) data.

[73 FR 75595, Dec. 12, 2008]



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:
    (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

[[Page 32]]

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 other payment arrangement 
or executory promise, and that the registration(s) shall not revert to 
the transferor unless a new transfer agreement is submitted to and 
approved by the Agency;

[[Page 33]]

    (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 
section 3(c)(1)(F) 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; 73 
FR 75595, Dec. 12, 2008]

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 Agency may identify a group of products having common 
characteristics or

[[Page 34]]

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.



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.

[[Page 35]]

    (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.
    (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:

[[Page 36]]

    (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 
subchronic 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 50 mg/kg or less as determined by extrapolation from 
tests conducted with technical material or directly with the formulated 
product; and

[[Page 37]]

    (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.

----------------------------------------------------------------------------------------------------------------
                                                                                                    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..

[[Page 38]]

 
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.
                                 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.

[[Page 39]]

 
                                 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.
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.

[[Page 40]]

 
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]

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

[[Page 41]]

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. 158.2000 and Sec. 158.2100, respectively, 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).

[53 FR 19114, May 26, 1988, as amended at 72 FR 61028, Oct. 26, 2007]



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
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

[[Page 42]]

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 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

[[Page 43]]

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 Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (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 Office of Pesticide Programs' 
Document Processing Desk as described 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 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; 71 FR 35545, June 21, 2006]

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.

[[Page 44]]

    (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 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,

[[Page 45]]

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.

                          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: 7 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,

[[Page 46]]

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.

    Terms used in this part have the same meaning as in the Act. In 
addition, as used in this part, the following terms shall apply:
    Act or FIFRA means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended.
    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.
    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).
    Other significant evidence means factually significant information 
that relates to the uses of the pesticide and its 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.
    Person means an applicant, registrant, manufacturer, pesticide user, 
environmental group, labor union, or other individual or group of 
individuals interested in pesticide regulation.
    Pesticide use means a use of a pesticide (described 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.
    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.
    Validated test means a test determined by the Agency to have been 
conducted and evaluated in a manner consistent with accepted scientific 
procedures.

[73 FR 75595, Dec. 12, 2008]



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

[[Page 47]]

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 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

[[Page 48]]

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 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 OPP Regulatory 
Public Docket located as set forth in 40 CFR 150.17(c).
    (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

[[Page 49]]

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; 71 
FR 35545, June 21, 2006]



                          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. Registrant(s) and applicant(s) will be 
allowed 30 days from the receipt of notification to respond in writing 
to dispute the validity of the Agency's conclusions 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 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.

[[Page 50]]



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 
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

[[Page 51]]

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.
    (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.

[[Page 52]]

    (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.



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

[[Page 53]]

    (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 AND REGISTRATION REVIEW--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.

                Subpart C_Registration Review Procedures

155.40 General.
155.42 Registration review cases.
155.44 Establish schedules for registration review.
155.46 Deciding that a registration review is complete and additional 
          review is not needed.
155.48 Data Call-In.
155.50 Initiate a pesticide's registration review.
155.52 Stakeholder engagement.
155.53 Conduct of a pesticide's registration review.
155.56 Interim registration review decision.
155.57 Registration review decision.
155.58 Procedures for issuing a decision on a registration review case.

    Authority: 7 U.S.C. 136a and 136w.

    Source: 50 FR 49001, Nov. 27, 1985, unless otherwise noted.

Subpart A [Reserved]



         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

[[Page 54]]

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.
    (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

[[Page 55]]

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 nonconfidential, 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 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;

[[Page 56]]

    (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.



                Subpart C_Registration Review Procedures

    Source: 71 FR 45732, Aug. 9, 2006, unless otherwise noted.



Sec. 155.40  General.

    (a) Purpose. These regulations establish procedures for the 
registration review program required in FIFRA section 3(g). Registration 
review is the periodic review of a pesticide's registration to ensure 
that each pesticide registration continues to satisfy the FIFRA standard 
for registration. Under FIFRA section 3(g), each pesticide is required 
to be reviewed every 15 years.
    (1) Among other things, FIFRA requires that a pesticide generally 
will not cause unreasonable adverse effects on the environment. 
Registration review is intended to ensure that each

[[Page 57]]

pesticide's registration is based on current scientific and other 
knowledge regarding the pesticide, including its effects on human health 
and the environment.
    (2) If a product fails to satisfy the FIFRA standard for 
registration, the product's registration may be subject to cancellation 
or other remedies under FIFRA.
    (b) Applicability. This subpart applies to every pesticide product 
registered under FIFRA section 3 as well as all pesticide products 
registered under FIFRA section 24(c). It does not apply to products 
whose sale or distribution is authorized under FIFRA section 5 or 
section 18.
    (c) Limitations. (1) At any time, the Agency may undertake any other 
review of a pesticide under FIFRA, irrespective of the pesticide's past, 
ongoing, scheduled, or not yet scheduled registration review.
    (2) When the Agency determines that new data or information are 
necessary for a pesticide's registration review, it will require such 
data under FIFRA section 3(c)(2)(B).

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75595, Dec. 12, 2008]



Sec. 155.42  Registration review cases.

    (a) Establishing registration review cases. A registration review 
case will be composed of one or more active ingredients and all the 
products containing such ingredient(s). The Agency may group related 
active ingredients into a registration review case when the active 
ingredients are so closely related in chemical structure and 
toxicological profile as to allow common use of some or all required 
data for hazard assessment.
    (1) Existing pesticides. The Agency will assign each pesticide 
registered on or before the effective date of this regulation to a 
registration review case.
    (2) New pesticides. The Agency will assign each pesticide registered 
after the effective date of this regulation to an existing registration 
review case or to a new registration review case.
    (3) A pesticide product that contains multiple active ingredients 
will belong to the registration review cases for each of its active 
ingredients.
    (b) Modifying registration review cases. New data or information may 
suggest that a registration review case should be modified. The Agency 
may modify a registration review case in the following ways:
    (1) Add a new active ingredient to a registration review case. The 
Agency may determine that a new active ingredient is chemically and 
toxicologically similar to active ingredients in an existing 
registration review case and should be grouped with the ingredients in 
the existing registration review case.
    (2) Split a registration review case into two or more registration 
review cases. For example, new data or information may suggest that 
active ingredients in a registration review case are not as similar as 
previously believed and that they belong in two or more separate 
registration review cases.
    (3) Move an ingredient from one registration review case to another. 
For example, new data or information might suggest that an ingredient 
should not be grouped with the other ingredients in the registration 
review case and that it belongs in a different registration review case.
    (4) Merge two or more registration review cases into a single 
registration review case. For example, new data or information might 
suggest that the active ingredients in two or more registration review 
cases should be grouped together for registration review.
    (5) Delete an active ingredient from a registration review case. For 
example, the Agency will remove the ingredient from the case if the 
registrations of all products containing an active ingredient in a 
registration review case are canceled.
    (c) Closing a registration review case. The Agency will close a 
registration review case if all products in the case are canceled.
    (d) Establishing a baseline date for a registration review case. For 
the purpose of scheduling registration reviews, the Agency will 
establish a baseline date for each registration review case. In general, 
the baseline date will be the date of initial registration of the oldest 
pesticide product in the case or the date of reregistration, whichever 
is

[[Page 58]]

later. For the purpose of these procedures, the date of reregistration 
is the date on which the Reregistration Eligibility Decision or Interim 
Reregistration Decision was signed, whichever date the Agency determines 
to be more appropriate based on the comprehensiveness of the review.
    (1) The Agency generally will not change the baseline date for a 
registration review case when it modifies a case by adding or deleting 
ingredients or products.
    (2) When the Agency splits a registration review case into two or 
more cases, the new case(s) generally will have the baseline date of the 
original registration review case.
    (3) When the Agency merges two or more registration review cases 
into a single case, the Agency generally will use the earliest baseline 
date as the baseline date for the new case.
    (e) Announcing registration review cases and baseline dates. The 
Agency will maintain a list of registration review cases, including 
baseline dates, on its website.



Sec. 155.44  Establish schedules for registration review.

    The Agency will develop schedules for registration review that are 
generally based on the baseline date of the registration review case or 
on the date of the latest registration review of the registration review 
case. The Agency may also take into account other factors, such as 
achieving process efficiencies by reviewing related cases together, when 
developing schedules for registration review. The Agency will maintain 
schedules for the current year and at least two subsequent years on its 
website.



Sec. 155.46  Deciding that a registration review is complete and 
additional review is not needed.

    The Agency may determine that there is no need to reconsider a 
previous decision that a pesticide satisfies the standard of 
registration in FIFRA. In such cases, instead of establishing a 
pesticide registration review case docket as described in Sec. 155.50, 
the Agency may propose that, based on its determination that a pesticide 
meets the FIFRA standard for registration, no further review will be 
necessary. In such circumstances, the Agency will publish a notice in 
the Federal Register announcing the availability of the proposed 
decision and provide a comment period of at least 60 calendar days. The 
Agency will publish a notice in the Federal Register announcing the 
availability of a final version of the decision, an explanation of any 
changes to the proposed decision and its response to any comments. The 
date of the final notice of availability would be used as the date of 
the latest registration review for the purpose of scheduling subsequent 
registration reviews.



Sec. 155.48  Data Call-In.

    The Agency may issue a Data Call-In notice under FIFRA section 
3(c)(2)(B) at any time if the Agency believes that the data are needed 
to conduct the registration review. The provisions in FIFRA section 
3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, compensation, 
and exemption of data required to conduct a registration review.



Sec. 155.50  Initiate a pesticide's registration review.

    The Agency will initiate a pesticide's registration review by 
establishing a docket for each registration review case, except for 
cases covered under Sec. 155.46, and opening it for public review.
    (a) Contents of the registration review case docket. The Agency will 
place in this docket information that will assist the public in 
understanding the types of information and issues that the Agency may 
consider in the course of the registration review. The Agency may 
include information from its files including, but not limited to, the 
following information:
    (1) An overview of registration review case status;
    (2) A list of current registrations and registrants, any Federal 
Register notices regarding pending registration actions, and current or 
pending tolerances;
    (3) Risk assessment documents;
    (4) Bibliographies concerning current registrations;
    (5) Summaries of incident data; and

[[Page 59]]

    (6) Any other pertinent data or information.
    (b) Public review of the registration review case docket. The Agency 
will publish a notice in the Federal Register announcing the 
availability for public review of the information described in paragraph 
(a) of this section and establishing a comment period of at least 60 
days. During this comment period, interested persons may identify any 
additional information they believe the Agency should consider in the 
course of the registration review.
    (c) Submission of data and other information during the comment 
period. The Agency may identify, either in the notice published under 
paragraph (b) of this section, or at any other time, data or information 
that it does not have but which may be useful, if available, for 
consideration in the registration review. Any person may submit data or 
information in response to such identification. In order to be 
considered during a pesticide's registration review, the submitted data 
or information must meet the requirements listed below.
    (1) In order to ensure that the Agency will consider data or 
information in the conduct of a registration review, interested persons 
must submit the data or information during the comment period 
established in the notice described in paragraph (b) of this section. 
The Agency may, at its discretion, consider data or information 
submitted at a later date.
    (2) The data or information must be presented in a legible and 
useable form. For example, an English translation must accompany any 
material that is not in English and a written transcript must accompany 
any information submitted as an audiographic or videographic record. 
Written material may be submitted in paper or electronic form.
    (3) Submitters must clearly identify the source of any submitted 
data or information.
    (4) Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    (d) For the purposes of this subpart, the provisions of subpart B do 
not apply.



Sec. 155.52  Stakeholder engagement.

    In addition to the public participation opportunities described in 
Sec. 155.50 and Sec. 155.53(c), the Agency may meet with stakeholders 
regarding a forthcoming or ongoing registration review. For example, 
before conducting a pesticide's registration review, the Agency may 
consult with registrants or pesticide users regarding the use and usage 
of the pesticide. The Agency may consult with registrants, pesticide 
users, or other persons during a pesticide's registration review with 
regard to developing risk management options for a pesticide. The Agency 
may informally consult with officials of Federal, State or Tribal 
agencies regarding a forthcoming or ongoing registration review.
    (a) Minutes of meetings with persons outside of government. Subject 
to paragraph (c) of this section, if the Agency meets with one or more 
individuals that are not government employees to discuss matters 
relating to a registration review, the Agency will place in the docket a 
list of meeting attendees, minutes of the meeting, and any documents 
exchanged at the meeting, not later than the earlier of:
    (1) 45 days after the meeting; or
    (2) The date of issuance of the registration review decision.
    (b) Exchange of documents or other written material. In the course 
of a meeting with a person outside of government, the Agency or that 
person may provide the other with a copy of a document or other written 
material that has not yet been released to the public. The Agency will 
place a copy of any such document or other written material in the 
docket along with the minutes of the meeting where the materials were 
exchanged.
    (c) Confidential business information. The Agency will identify, but 
not include in the docket, any confidential business information whose 
disclosure is prohibited by FIFRA section 10.

[71 FR 45732, Aug. 9, 2006, as amended at 73 FR 75596, Dec. 12, 2008]

[[Page 60]]



Sec. 155.53  Conduct of a pesticide's registration review.

    The Agency will review data and information described in Sec. 
155.50(a), (b), and (c) or submitted in response to a Data Call-In 
notice that it believes should be considered in the pesticide's 
registration review.
    (a) Assess changes since a pesticide's last review. The Agency will 
assess any changes that may have occurred since the Agency's last 
registration decision in order to determine the significance of such 
changes and whether the pesticide still satisfies the FIFRA standard for 
registration. The Agency will consider whether to conduct a new risk 
assessment to take into account, among other things, any changes in 
statutes or regulations, policy, risk assessment procedures or methods, 
or data requirements. The Agency will consider whether any new data or 
information on the pesticide, including any data or information 
submitted under Sec. 155.50 or in response to a Data Call-In notice, 
warrant conducting a new risk assessment or a new risk/benefit 
assessment. The Agency will also consider whether any new data or 
information regarding an individual pesticide product, including any 
data or information submitted under Sec. 155.50 or in response to a 
Data Call-In notice, such as data or information about an inert 
ingredient in the pesticide product or other information or data 
relating to the composition, labeling or use of the pesticide product, 
warrant additional review of a pesticide product's registration.
    (b) Conduct new assessments as needed. (1) Active ingredient(s) in 
the registration review case. If the Agency finds that a new assessment 
of the pesticide is needed, it will determine whether it can base the 
new assessment on available data or information, including data or 
information submitted under Sec. 155.50 or in response to a Data Call-
In notice. If sufficient data or information are available, the Agency 
will conduct the new risk assessment or risk/benefit assessment. If the 
Agency determines that additional data or information are needed to 
conduct the review, the Agency will issue a Data Call-In notice under 
FIFRA section 3(c)(2)(B).
    (2) Individual product registrations. If the Agency finds that 
additional review of an individual product's registration is needed, it 
will review the pesticide product label, confidential statement of 
formula, product-specific data, or other pertinent data or information, 
as appropriate, to determine whether the registration of the individual 
product meets the FIFRA standard for registration. If the Agency 
determines that additional data or information are needed to conduct the 
review, the Agency will issue a Data Call-In notice under FIFRA section 
3(c)(2)(B).
    (c) Public participation during a pesticide's registration review. 
The Agency will generally make available for public review and comment a 
draft risk assessment for a pesticide if a new risk assessment has been 
conducted. The Agency will publish a notice in the Federal Register 
announcing the availability of the draft risk assessment and provide a 
comment period of at least 30 calendar days. The Agency will publish a 
notice in the Federal Register announcing the availability of a revised 
risk assessment, an explanation of any changes to the proposed document, 
and its response to comments. If the revised risk assessment indicates 
risks of concern, the Agency may, in the notice announcing the 
availability of the revised risk assessment, provide a comment period of 
at least 30 calendar days for the public to submit suggestions for 
mitigating the risk identified in the revised risk assessment.
    (1) The Agency might not request comments on a draft risk assessment 
in cases where the Agency's initial screening of a pesticide indicates 
that it has low use/usage, affects few if any stakeholders or members of 
the public, poses low risk, and/or requires little or no risk 
mitigation. In such cases, the Agency will make a draft risk assessment 
available for public review and comment when it issues a proposed 
decision on the registration review case.
    (2) If the Agency finds that it is not necessary to conduct a new 
risk assessment, it will issue a proposed decision on the registration 
review case as described in Sec. 155.58.

[[Page 61]]



Sec. 155.56  Interim registration review decision.

    The Agency may issue, when it determines it to be appropriate, an 
interim registration review decision before completing a registration 
review. Among other things, the interim registration review decision may 
require new risk mitigation measures, impose interim risk mitigation 
measures, identify data or information required to complete the review, 
and include schedules for submitting the required data, conducting the 
new risk assessment and completing the registration review. A FIFRA 
3(c)(2)(B) notice requiring the needed data or information may precede, 
accompany, or follow issuance of the interim registration review 
decision. The Agency will follow procedures in Sec. 155.58 when issuing 
an interim registration review decision.



Sec. 155.57  Registration review decision.

    A registration review decision is the Agency's determination whether 
a pesticide meets, or does not meet, the standard for registration in 
FIFRA.



Sec. 155.58  Procedures for issuing a decision on a registration review 
case.

    (a) The Agency will publish a notice in the Federal Register 
announcing the availability of a proposed registration review decision 
or a proposed interim registration review decision. At that time, the 
Agency will place in the pesticide's registration review docket the 
Agency's proposed decision and the bases for the decision. There will be 
a comment period of at least 60 calendar days on the proposed decision.
    (b) In its proposed decision, the Agency will, among other things:
    (1) State its proposed findings with respect to the FIFRA standard 
for registration and describe the basis for such proposed findings.
    (2) Identify proposed risk mitigation measures or other remedies as 
needed and describe the basis for such proposed requirements.
    (3) State whether it believes that additional data are needed and, 
if so, describe what is needed. A FIFRA 3(c)(2)(B) notice requiring such 
data may be issued in conjunction with a proposed or final decision on 
the registration review case or a proposed or final interim decision on 
a registration review case.
    (4) Specify proposed labeling changes; and
    (5) Identify deadlines that it intends to set for completing any 
required actions.
    (c) After considering any comments on the proposed decision, the 
Agency will issue a registration review decision or interim registration 
review decision. This decision will include an explanation of any 
changes to the proposed decision and the Agency's response to 
significant comments. The Agency will publish a notice in the Federal 
Register announcing the availability of a registration review decision 
or interim registration review decision. The registration review case 
docket will remain open until all actions required in the final decision 
on the registration review case have been completed.
    (d) If the registrant fails to take the action required in a 
registration review decision or interim registration review decision, 
the Agency may take appropriate action under FIFRA.



PART 156_LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table 
of Contents




                      Subpart A_General Provisions

Sec.
156.3 Definitions.
156.10 Labeling requirements.

Subparts B-C [Reserved]

           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-G [Reserved]

[[Page 62]]

                      Subpart H_Container Labeling

156.140 Identification of container types.
156.144 Residue removal instructions--general.
156.146 Residue removal instructions for nonrefillable containers--rigid 
          containers with dilutable pesticides.
156.156 Residue removal instructions for refillable containers.
156.159 Compliance date.

Subparts I-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. 156.3  Definitions.

    Terms used in this part have the same meaning as in the Act and part 
152 of this chapter. In addition, as used in this part, the following 
terms shall have the meanings set forth below.
    Dilutable means that the pesticide product's labeling allows or 
requires the pesticide product to be mixed with a liquid diluent prior 
to application or use.
    Transport vehicle means a cargo-carrying vehicle such as an 
automobile, van, tractor, truck, semitrailer, tank car or rail car used 
for the transportation of cargo by any mode.

[73 FR 64224, Oct. 29, 2008]



Sec. 156.10  Labeling requirements.

    (a) General--(1) Contents of the label. Every pesticide product 
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''

[[Page 63]]

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.
    (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,'' ``harmless'' 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

[[Page 64]]

    (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 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.
    (7) For a pesticide product packaged in a refillable container, an 
appropriately sized area on the label may be left blank to allow the net 
weight or measure of content to be marked in by the refiller according 
to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale of the 
pesticide. As required in paragraph (a)(1)(iii) of this section, the net 
contents must be shown clearly and prominently on the label.
    (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 establishment's 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. For a pesticide product 
packaged in a refillable container, an appropriately sized area on the 
label may be left blank after the phrase ``EPA Est.'' to allow the EPA 
establishment registration number to be marked in by the refiller 
according to 40 CFR 165.65(h) or 165.70(i) prior to distribution or sale 
of the pesticide.
    (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

[[Page 65]]

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 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

[[Page 66]]

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 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, residue removal and 
disposal of the pesticide and its container, in accordance with subpart 
H of this part. These instructions must 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. 156.60(b))
    (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 Sec. 156.78(d)(1), the 
following

[[Page 67]]

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. Any pesticide product for which 
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; 71 FR 47420, Aug. 16, 2006; 73 FR 75596, Dec. 12, 2008]

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

[[Page 68]]

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. 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

[[Page 69]]

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 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.''

[[Page 70]]

    (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 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

[[Page 71]]

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
 
--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

[[Page 72]]

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 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-G [Reserved]



                      Subpart H_Container Labeling

    Source: 71 FR 47420, Aug. 16, 2006, unless otherwise noted.



Sec. 156.140  Identification of container types.

    For products other than plant-incorporated protectants, the 
following statements, as applicable, must be placed on the label or 
container. The information may be located on any part of the container 
except the closure. If the statements are placed on the container, they 
must be durably marked on the container. Durable marking includes, but 
is not limited to etching, embossing, ink jetting, stamping, heat 
stamping, mechanically attaching a plate, molding, or marking with 
durable ink.
    (a) Nonrefillable container. For nonrefillable containers, the 
statements in paragraphs (a)(1) through (a)(4) of this section are 
required except as provided in paragraphs (a)(5), (c), (d), and (e) of 
this section. If placed on the label, the statements in paragraphs 
(a)(1) through (a)(3) of this section must be under an appropriate 
heading under the heading ``Storage and Disposal.'' If any of the 
statements in paragraphs (a)(1) through (a)(3) of this section are 
placed on the container, an appropriate referral statement such as ``See 
container for recycling [or other descriptive word] information.'' must 
be placed on the label under the heading ``Storage and Disposal.''
    (1) Statement identifying a nonrefillable container. The following 
phrase is required: ``Nonrefillable container.''
    (2) Reuse statement. One of the following statements is required. 
Products with labels that allow household/residential use must use the 
statement in paragraph (a)(2)(i) or (a)(2)(iii) of this section. All 
other products must

[[Page 73]]

use the statement in paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of 
this section.
    (i) ``Do not reuse or refill this container.''
    (ii) ``Do not reuse this container to hold materials other than 
pesticides or dilute pesticides (rinsate). After emptying and cleaning, 
it may be allowable to temporarily hold rinsate or other pesticide-
related materials in the container. Contact your state regulatory agency 
to determine allowable practices in your state.''
    (iii) The following statement may be used if a product is ``ready-
to-use'' and its directions for use allow a different product (that is a 
similar, but concentrated formulation) to be poured into the container 
and diluted by the end user: ``Do not reuse or refill this container 
unless the directions for use allow a different (concentrated) product 
to be diluted in the container.''
    (3) Recycling or reconditioning statement. One of the following 
statements is required:
    (i) ``Offer for recycling if available.''
    (ii) ``Once cleaned, some agricultural plastic pesticide containers 
can be taken to a container collection site or picked up for recycling. 
To find the nearest site, contact your chemical dealer or manufacturer 
or contact [a pesticide container recycling organization] at [phone 
number] or [web site]. For example, this statement could be ``Once 
cleaned, some agricultural plastic pesticide containers can be taken to 
a container collection site or picked up for recycling. To find the 
nearest site, contact your chemical dealer or manufacturer or contact 
the Ag Container Recycling Council (ACRC) at 1-877-952-2272 (toll-free) 
or www.acrecycle.org.''
    (iii) A recycling statement approved by EPA and published in an EPA 
document, such as a Pesticide Registration Notice.
    (iv) An alternative recycling statement that has been reviewed and 
approved by EPA.
    (v) ``Offer for reconditioning if appropriate.''
    (4) Batch code. A lot number, or other code used by the registrant 
or producer to identify the batch of the pesticide product which is 
distributed and sold is required.
    (5) Exemptions. Pesticide products in the following types of 
nonrefillable containers, and their packaging, are exempt from the 
requirements in paragraphs (a)(1) and (a)(2) of this section:
    (i) Aerosol cans.
    (ii) Devices as defined in Sec. 152.500 of this chapter.
    (iii) One-time use caulking tubes and other one-time use squeezable 
tube containers for paste, gel, or other similar substances.
    (iv) Foil packets for water soluble packaging, repellent wipes, and 
other one-time use products.
    (v) One-time use portion control packets, such as polyethylene 
sleeve packages, or rodenticide placepacks.
    (vi) One-time use bait stations.
    (vii) One-time use cages for repellent or trapping strips.
    (viii) Pet collars or animal ear tags, such as cattle ear tags.
    (ix) One-time use semiochemical dispersion devices.
    (x) Any container that is destroyed by the use of the product 
contained.
    (xi) Any container that would be destroyed if reuse of the container 
were attempted.
    (b) Refillable container. For refillable containers, one of the 
following statements is required, except as provided in paragraphs (c), 
(d), and (e) of this section. If placed on the label, the statement must 
be under the heading ``Storage and Disposal.'' If the statement is 
placed on the container, an appropriate referral statement, such as 
``Refilling limitations are on the container.'' must be placed under the 
heading ``Storage and Disposal.''
    (1) ``Refillable Container. Refill this container with pesticide 
only. Do not reuse this container for any other purpose.''
    (2) ``Refillable Container. Refill this container with [common 
chemical name] only. Do not reuse this container for any other 
purpose.''
    (c) Modification. EPA may, on its own initiative or based on data or 
information submitted by any person, modify or waive the requirements of 
this section or permit or require alternative labeling statements.
    (d) Exemption for articles. Pesticidal articles that are not 
exempted from FIFRA regulation by Sec. 152.25(a) of this

[[Page 74]]

chapter are exempt from the requirements of this section.
    (e) Exemption for transport vehicles. Transport vehicles are exempt 
from the requirements of this section.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]



Sec. 156.144  Residue removal instructions--general.

    (a) General. Except as provided by paragraphs (c) through (g) of 
this section, the label of each pesticide product must include the 
applicable instructions for removing pesticide residues from the 
container prior to container disposal that are specified in Sec. 
156.146 and Sec. 156.156. The residue removal instructions are required 
for both nonrefillable and refillable containers.
    (b) Placement of residue removal statements. All residue removal 
instructions must be placed under the heading ``Storage and Disposal.''
    (c) Exemption for residential/household use products. Residential/
household use pesticide products are exempt from the residue removal 
instruction requirements in this section through Sec. 156.156.
    (d) Modification. EPA may, on its own initiative or based on data 
submitted by any person, modify or waive the requirements of this 
section through Sec. 156.156, or permit or require alternative labeling 
statements.
    (e) Exemption for gases. Pesticide products that are gaseous at 
atmospheric temperature and pressure are exempt from the residue removal 
instruction requirements in this section through Sec. 156.156.
    (f) Exemption for articles. Pesticidal articles that are not 
exempted from FIFRA regulation by Sec. 152.25(a) of this chapter are 
exempt from the residue removal instruction requirements in this section 
through Sec. 156.156.
    (g) Exemption for transport vehicles. Transport vehicles are exempt 
from the requirements in this section through Sec. 156.156.

[71 FR 47420, Aug. 16, 2006, as amended at 73 FR 64224, Oct. 29, 2008]



Sec. 156.146  Residue removal instructions for nonrefillable 
containers--rigid containers with dilutable pesticides.

    The label of each dilutable (liquid or solid) pesticide product 
packaged in a rigid nonrefillable container must include the following 
residue removal instructions as appropriate.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraphs (b) and (c) of this section:
    (1) ``Clean container promptly after emptying.''
    (2) ``Triple rinse or pressure rinse container (or equivalent) 
promptly after emptying.''
    (3) ``Triple rinse container (or equivalent) promptly after 
emptying.''
    (b) Triple rinse instructions. The label of each dilutable pesticide 
product packaged in rigid nonrefillable containers must include one of 
the following sets of instructions.
    (1) For liquid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank and drain for 10 seconds after the flow begins to drip. Fill 
the container 1/4 full with water and recap. Shake for 10 seconds. Pour 
rinsate into application equipment or a mix tank or store rinsate for 
later use or disposal. Drain for 10 seconds after the flow begins to 
drip. Repeat this procedure two more times.''
    (2) For solid dilutable pesticide products in containers small 
enough to shake, use the following instructions: ``Triple rinse as 
follows: Empty the remaining contents into application equipment or a 
mix tank. Fill the container 1/4 full with water and recap. Shake for 10 
seconds. Pour rinsate into application equipment or a mix tank or store 
rinsate for later use or disposal. Drain for 10 seconds after the flow 
begins to drip. Repeat this procedure two more times.''
    (3) For containers that are too large to shake, use the following 
instructions: ``Triple rinse as follows: Empty remaining contents into 
application

[[Page 75]]

equipment or a mix tank. Fill the container 1/4 full with water. Replace 
and tighten closures. Tip container on its side and roll it back and 
forth, ensuring at least one complete revolution, for 30 seconds. Stand 
the container on its end and tip it back and forth several times. Turn 
the container over onto its other end and tip it back and forth several 
times. Empty the rinsate into application equipment or a mix tank or 
store rinsate for later use or disposal. Repeat this procedure two more 
times.''
    (c) Pressure rinse instructions. The label of each dilutable 
pesticide product packaged in rigid nonrefillable containers may include 
one of the following sets of instructions, and one of them must be used 
if the statement in paragraph (a)(2) of this section is used. If one of 
these statements is included on the label, it must immediately follow 
the triple rinse instructions specified in paragraph (b) of this 
section.
    (1) For liquid dilutable pesticide products, use the following label 
instruction: ``Pressure rinse as follows: Empty the remaining contents 
into application equipment or a mix tank and continue to drain for 10 
seconds after the flow begins to drip. Hold container upside down over 
application equipment or mix tank or collect rinsate for later use or 
disposal. Insert pressure rinsing nozzle in the side of the container, 
and rinse at about 40 PSI for at least 30 seconds. Drain for 10 seconds 
after the flow begins to drip.''
    (2) For solid dilutable pesticide products, use the following label 
instruction: ``Pressure rinse as follows: Empty the remaining contents 
into application equipment or a mix tank. Hold container upside down 
over application equipment or mix tank or collect rinsate for later use 
or disposal. Insert pressure rinsing nozzle in the side of the 
container, and rinse at about 40 PSI for at least 30 seconds. Drain for 
10 seconds after the flow begins to drip.''
    (d) Non-water diluent. (1) A registrant who wishes to require users 
to clean a container with a diluent other than water (e.g., solvents) 
must submit to EPA a written request to modify the residue removal 
instructions of this section. The registrant may not distribute or sell 
the pesticide with the modified residue removal instructions until EPA 
approves the request in writing.
    (2) The registrant must indicate why a non-water diluent is 
necessary for efficient residue removal, and must propose residue 
removal instructions and disposal instructions that are appropriate for 
the characteristics and formulation of the pesticide product and non-
water diluent. The proposed residue removal instructions must identify 
the diluent. If the Directions for Use permit the application of a 
mixture of the pesticide and the non-water diluent, the instructions may 
allow the rinsate to be added to the application equipment or mix tank. 
If the Directions for Use do not identify the non-water diluent as an 
allowable addition to the pesticide, the instructions must require 
collection and storage of the rinsate in a rinsate collection system.
    (3) EPA may approve the request if EPA finds that the proposed 
instructions are necessary and appropriate.



Sec. 156.156  Residue removal instructions for refillable containers.

    The label of each pesticide product packaged in a refillable 
container must include the residue removal instructions in this section. 
Instructions must be given for all pesticide products that are 
distributed or sold in refillable containers, including those that do 
not require dilution prior to application.
    (a) Timing of the residue removal procedure. One of the following 
statements must immediately precede the instructions required in 
paragraph (b) of this section and must be consistent with the 
instructions in paragraph (b) of this section:
    (1) ``Cleaning the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning before 
refilling is the responsibility of the refiller.''
    (2) ``Pressure rinsing the container before final disposal is the 
responsibility of the person disposing of the container. Cleaning before 
refilling is the responsibility of the refiller.''
    (b) Residue removal instructions prior to container disposal. (1) 
Instructions for cleaning each refillable container prior to disposal 
are required. The residue

[[Page 76]]

removal instructions must be appropriate for the characteristics and 
formulation of the pesticide product and must be adequate to protect 
human health and the environment.
    (2) Subject to meeting the standard in paragraph (b)(1) of this 
section, the statement on residue removal instructions could include any 
one of the following:
    (i) The refilling residue removal procedure developed by the 
registrant for the pesticide product.
    (ii) Standard industry practices for cleaning refillable containers.
    (iii) For pesticides that require dilution prior to application, the 
following statement: ``To clean the container before final disposal, 
empty the remaining contents from this container into application 
equipment or a mix tank. Fill the container about 10 percent full with 
water. Agitate vigorously or recirculate water with the pump for 2 
minutes. Pour or pump rinsate into application equipment or rinsate 
collection system. Repeat this rinsing procedure two more times.''
    (iv) Any other statement the registrant considers appropriate.



Sec. 156.159  Compliance date.

    Any pesticide product released for shipment by a registrant after 
August 16, 2010 must bear a label that complies with Sec. Sec. 
156.10(d)(7), 156.10(f), 156.10(i)(2)(ix), 156.140, 156.144, 156.146, 
and 156.156.

[73 FR 64224, Oct. 29, 2008]

Subparts I-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. No product to which this subpart applies shall 
be distributed or sold without amended labeling by any registrant after 
April 21, 1994, or by any person after October 23, 1995.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



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:
    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.

[[Page 77]]

    Restricted-entry interval or REI means the time after the end of a 
pesticide application during which entry to the treated area is 
restricted.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



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 conducted according to 
Subdivisions U or K of the Pesticide Assessments guidelines or data from 
medical, epidemiological, or health effects studies. 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.

[57 FR 38146, Aug. 21, 1992, as amended at 73 FR 75596, Dec. 12, 2008]



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.
    (c) Product-type identification. (1) If the product contains an 
organophosphate (i.e., an organophosphorus ester that inhibits 
cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic 
acid ester that inhibits cholinesterase), the label shall so state. The 
statement shall be associated with the product name or product-type 
identification or

[[Page 78]]

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. 156.62, 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; 
73 FR 75596, Dec. 12, 2008]



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/m\3\ 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. 156.62. 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.
    (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

[[Page 79]]

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. 158.1070 or Sec. 161.390 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; 
72 FR 61028, Oct. 26, 2007; 73 FR 75596, Dec. 12, 2008]



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. 156.62 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 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.

[[Page 80]]

    (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; 
73 FR 75596, Dec. 12, 2008]



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. 156.62. 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 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

[[Page 81]]

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 device   protection device
                                   \3\                 \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.''
    (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

[[Page 82]]

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 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--

[[Page 83]]

(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; 
73 FR 75596, Dec. 12, 2008]



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.

    Authority: 7 U.S.C. 136w.

    Source: 51 FR 21286, June 11, 1986; 51 FR 36692, Oct. 15, 1986, 
unless otherwise noted.

[[Page 84]]

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:
     Appropriate, when used with respect to child-resistant packaging, 
means that the packaging is chemically compatible with the pesticide 
contained therein.
     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 within a reasonable time, and that is not difficult 
for normal adults to use properly.
     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.
     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.
     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.
     Technically feasible, when applied to child-resistant packaging, 
means that the technology exists to produce the child-resistant 
packaging for a particular pesticide.
     Unit packaging means a package that is labeled with directions to 
use the entire contents of the package in a single application.

[51 FR 21286, June 11, 1986, as amended at 73 FR 75596, Dec. 12, 2008]



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
    (b) Use criterion. The product's labeling either directly recommends 
residential use or reasonably can be interpreted to permit residential 
use.

[[Page 85]]



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.
    (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

[[Page 86]]

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 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.

[[Page 87]]



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 
registration, 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).
    (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; 51 FR 36692, Oct. 15, 1986, as amended at 
65 FR 39304, June 26, 2000]

[[Page 88]]



PART 158_DATA REQUIREMENTS FOR PESTICIDES--Table of Contents




                      Subpart A_General Provisions

Sec.
158.1 Purpose and scope.
158.3 Definitions.
158.5 Applicability.
158.30 Flexibility.
158.32 Format of data submissions.
158.33 Confidential data.
158.34 Flagging of studies for potential adverse effects.
158.45 Waivers.
158.60 Minor use data policies.
158.70 Satisfying data requirements.
158.75 Requirements for additional data.
158.80 Use of other data.

                    Subpart B_How To Use Data Tables

158.100 Pesticide use patterns.
158.110 Required and conditionally required data.
158.120 Determining data requirements.
158.130 Purposes of the registration data requirements.

                   Subpart C_Experimental Use Permits

158.200 Experimental use permit data requirements tables.
158.210 Experimental use permit data requirements for product chemistry
158.220 Experimental use permit data requirements for product 
          performance.
158.230 Experimental use permit data requirements for toxicology.
158.240 Experimental use permit data requirements for ecological 
          effects.
158.243 Experimental use permit data requirements for terrestrial and 
          aquatic nontarget organisms.
158.250 Experimental use permit data requirements for human exposure.
158.260 Experimental use permit data requirements for environmental 
          fate.
158.270 Experimental use permit data requirements for residue chemistry.
158.280-158.290 [Reserved]

                       Subpart D_Product Chemistry

158.300 Definitions.
158.310 Product chemistry data requirements table.
158.320 Product identity and composition.
158.325 Description of materials used to produce the product.
158.330 Description of production process.
158.335 Description of formulation process.
158.340 Discussion of formation of impurities.
158.345 Preliminary analysis.
158.350 Certified limits.
158.355 Enforcement analytical method.

                      Subpart E_Product Performance

158.400 Product performance data requirements.

                          Subpart F_Toxicology

158.500 Toxicology data requirements table.
158.510 Tiered testing options for nonfood pesticides.

                      Subpart G_Ecological Effects

158.630 Terrestrial and aquatic nontarget organisms data requirements 
          table.
158.660 Nontarget plant protection data requirements table.

                         Subparts H	J [Reserved]

158.700-158.900 [Reserved]

                        Subpart K_Human Exposure

158.1000 Applicator exposure--general requirements.
158.1010 Applicator exposure--criteria for testing.
158.1020 Applicator exposure data requirements table.
158.1050 Post-application exposure--general requirements.
158.1060 Post-application exposure--criteria for testing.
158.1070 Post-application exposure data requirements table.

                          Subpart L_Spray Drift

158.1100 Spray drift data requirements table.

                          Subpart M [Reserved]

158.1200-158.1299 [Reserved]

                      Subpart N_Environmental Fate

158.1300 Environmental fate data requirements table.

                       Subpart O_Residue Chemistry

158.1400 Definitions.
158.1410 Residue chemistry data requirements table.

                         Subparts P	T [Reserved]

158.1500-158.1900 [Reserved]

                    Subpart U_Biochemical Pesticides

158.2000 Biochemical pesticides definition and applicability.
158.2010 Biochemical pesticides data requirements.
158.2030 Biochemical pesticides product chemistry data requirements 
          table.

[[Page 89]]

158.2040 Biochemical pesticides residue data requirements table.
158.2050 Biochemical pesticides human health assessment data 
          requirements table.
158.2060 Biochemical pesticides nontarget organisms and environmental 
          fate data requirements table.
158.2070 Biochemical pesticides product performance data requirements.
158.2080 Experimental use permit data requirements--biochemical 
          pesticides.
158.2081 Experimental use permit biochemical pesticides product 
          chemistry data requirements table.
158.2082 Experimental use permit biochemical pesticides residue data 
          requirements table.
158.2083 Experimental use permit biochemical pesticides human health 
          assessment data requirements table.
158.2084 Experimental use permit biochemical pesticides nontarget 
          organisms and environmental fate data requirements table.

                     Subpart V_ Microbial Pesticides

158.2100 Microbial pesticides definition and applicability.
158.2110 Microbial pesticides data requirements.
158.2120 Microbial pesticides product analysis data requirements table.
158.2130 Microbial pesticides residue data requirements table.
158.2140 Microbial pesticides toxicology data requirements table.
158.2150 Microbial pesticides nontarget organisms and environmental fate 
          data requirements table.
158.2160 Microbial pesticides product performance data requirements.
158.2170 Experimental use permit data requirements--microbial 
          pesticides.
158.2171 Experimental use permit microbial pesticides product analysis 
          data requirements table.
158.2172 Experimental use permit microbial pesticides residue data 
          requirements table.
158.2173 Experimental use permit microbial pesticides toxicology data 
          requirements table.
158.2174 Experimental use permit microbial pesticides nontarget 
          organisms and environmental fate data requirements table.

              Subpart W_Antimicrobial Pesticides [Reserved]

158.2200 [Reserved]

                         Subpart X	Z [Reserved]

158.2300-158.2500 [Reserved]

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a.

    Source: 72 FR 60957, Oct. 26, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec. 158.1  Purpose and scope.

    (a) Purpose. The purpose of this part is to specify the kinds of 
data and information EPA requires in order to make regulatory judgments 
under FIFRA secs. 3, 4, and 5 about the risks and benefits of pesticide 
products. Further, this part specifies the data and information needed 
to determine the safety of pesticide chemical residues under FFDCA sec. 
408.
    (b) Scope. (1) This part describes the minimum data and information 
EPA typically requires to support an application for pesticide 
registration or amendment; support the reregistration of a pesticide 
product; support the maintenance of a pesticide registration by means of 
the data call-in process, e.g., as used in the registration review 
program; or establish or maintain a tolerance or exemption from the 
requirements of a tolerance for a pesticide chemical residue.
    (2) This part establishes general policies and procedures associated 
with the submission of data in support of a pesticide regulatory action.
    (3) This part does not include study protocols, methodology, or 
standards for conducting or reporting test results; nor does this part 
describe how the Agency uses or evaluates the data and information in 
its risk assessment and risk management decisions, or the regulatory 
determinations that may be based upon the data.
    (c) Scope of individual subparts. (1) Conventional pesticides. 
Subparts A, B, C, D, F, G, K, L, N, and O apply to conventional 
pesticides.
    (2) Biochemical pesticides. Subparts A, B and U apply to biochemical 
pesticides.
    (3) Microbial pesticides. Subparts A, B and V apply to microbial 
pesticides.
    (4) Antimicrobial pesticides. [Reserved]



Sec. 158.3  Definitions.

    All terms defined in sec. 2 of the Federal Insecticide, Fungicide, 
and Rodenticide Act apply to this part and

[[Page 90]]

are used with the meaning given in the Act. Applicable terms from the 
Federal Food, Drug, and Cosmetic Act also apply to this part. Individual 
subparts may contain definitions that pertain solely to that subpart. 
The following additional terms apply to this part:
    Applicant means any person or entity, including for the purposes of 
this part a registrant, who submits, or is required to submit, to the 
Agency any application, petition, or submission 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. Such 
submissions may include, but are not limited to, the following:
    (1) An application for registration or amended registration of a 
pesticide product under FIFRA sec. 3 or 24.
    (2) A submission of data required in conjunction with reregistration 
of a currently registered product under FIFRA sec. 4.
    (3) An application for an experimental use permit under FIFRA sec. 
5.
    (4) A submission of data in response to a notice issued by EPA under 
FIFRA sec. 3(c)(2)(B).
    (5) A petition to establish or modify a tolerance or an exemption 
from the requirement of a tolerance for a pesticide chemical residue 
under FFDCA sec. 408.
    Registration includes a new registration, amended registration and 
reregistration, unless stated otherwise.



Sec. 158.5  Applicability.

    (a) The requirements of this part apply to the following 
submissions:
    (1) An application for new or amended registration under FIFRA sec. 
3 or 24.
    (2) An application for experimental use permit under FIFRA sec. 5.
    (3) A submission of data or information to support the continuation 
of a registration under FIFRA sec. 3, 4, or 24.
    (4) A petition to establish, modify or revoke a tolerance or 
exemption from a tolerance under FFDCA sec. 408.
    (b) The information specified in this part must be furnished with 
each submission described in paragraph (a) of this section if it has not 
been submitted previously, or if any previous submission is not accurate 
or complete.



Sec. 158.30  Flexibility.

    (a) FIFRA provides EPA flexibility to require, or not require, data 
and information for the purposes of making regulatory judgments for 
pesticide products. EPA has the authority to establish or modify data 
needs for individual pesticide chemicals. The actual data required may 
be modified on an individual basis to fully characterize the use and 
properties, characteristics, or effects of specific pesticide products 
under review. The Agency encourages each applicant to consult with EPA 
to discuss the data requirements particular to its product prior to and 
during the registration process.
    (b) The Agency cautions applicants that the data routinely required 
in this part may not be sufficient to permit EPA to evaluate the 
potential of the product to cause unreasonable adverse effects to man or 
the environment. EPA may require the submission of additional data or 
information beyond that specified in this part if such data or 
information are needed to appropriately evaluate a pesticide product.
    (c) This part will be updated as needed to reflect evolving program 
needs and advances in science.



Sec. 158.32  Format of data submissions.

    (a) General. (1) All data submitted under this part must be 
formatted in accordance with this section.
    (2) The requirements of this section do not apply to administrative 
materials accompanying a data submission, including forms, labeling, and 
correspondence.
    (b) Transmittal document. Each submission in support of a regulatory 
action must be accompanied by a transmittal document, which includes:
    (1) Identity of the submitter.
    (2) The transmittal date.
    (3) Identification of the regulatory action with which the 
submission is associated, e.g., the registration or petition number.
    (4) A list of the individual documents included in the submission.
    (c) Individual documents. Unless otherwise specified by the Agency, 
each

[[Page 91]]

submission must be in the form of individual documents or studies. 
Previously submitted documents should not be resubmitted unless 
specifically requested by the Agency, but should be cited with adequate 
information to identify the previously submitted document. Each study or 
document should include the following:
    (1) A title page including the following information:
    (i) The title of the study, including identification of the 
substance(s) tested and the test name or data requirement addressed.
    (ii) The author(s) of the study.
    (iii) The date the study was completed.
    (iv) If the study was performed in a laboratory, the name and 
address of the laboratory, project numbers or other identifying codes.
    (v) 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.
    (vi) 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.
    (2) The appropriate statement(s) regarding any data confidentiality 
claims as described in Sec. 158.33.
    (3) A statement of compliance or non-compliance with respect to Good 
Laboratory Practice Standards as required by 40 CFR 160.12, if 
applicable.
    (4) A complete and accurate English translation must be included for 
any information that is not in English.
    (5) A flagging statement as prescribed by Sec. 158.34, if 
applicable.



Sec. 158.33  Confidential data.

    (a) Definitions. For the purposes of this section:
    (1) Registered or previously registered pesticide means any 
pesticide containing an active ingredient contained in a product that 
is, or has ever been, an active ingredient in a product registered under 
sec. 3 of FIFRA. A registered pesticide that is the subject of an 
application for a new use falls within the category of ``registered or 
previously registered pesticide.''
    (2) Safety and efficacy information means information concerning the 
objectives, methodology, results, or significance of any test or 
experiment performed on or with a registered or previously registered 
pesticide or its separate ingredients, impurities, or degradation 
products, and any information concerning the effects of such pesticide 
on any organism or the behavior of such pesticide in the environment, 
including, but not limited to, data on safety to fish and wildlife, 
humans and other mammals, plants, animals, and soil, and studies on 
persistence, translocation and fate in the environment, and metabolism.
    (b) Applicability. (1) This section applies to information submitted 
pursuant to this part. It supplements the general confidentiality 
procedures in 40 CFR part 2, subpart B, including FIFRA confidentiality 
procedures at 40 CFR 2.307. To the extent that provisions in this 
section conflict with those in 40 CFR part 2, subpart B, the provisions 
in this section take precedence. The provisions of 40 CFR 2.308 do not 
apply to information to which this section applies. In addition to 
complying with the requirements of this section, any confidentiality 
claims for information subject to 40 CFR part 174 (plant-incorporated 
protectants) must be substantiated at the time of submission as 
described in Sec. 174.9 of this chapter.
    (2) FFDCA sec. 408(i) protects confidential information submitted in 
connection with an application for a tolerance or exemption to the same 
extent as FIFRA sec. 10. References in this section to FIFRA sec. 10 are 
deemed to apply equally to information submitted pursuant to FFDCA sec. 
408, pursuant to the authority in sec. 408(i).
    (c) Method of asserting business confidentiality claims--(1) Claim 
required. Information to which this section applies (and which is 
submitted on or after the effective date of this regulation) will be 
deemed as not subject to a confidentiality claim unless a claim for that 
information is made in accordance with the procedures specified in this 
paragraph. Information not subject to a confidentiality claim may be 
made available to the public without further notice, subject to the 
requirements of FIFRA sec. 10(g).

[[Page 92]]

    (2) Statement required. Upon submission to EPA, each document must 
be accompanied by a signed and dated document containing either the 
statements in paragraph (c)(2)(i) or (ii) of this section. No claims or 
markings on the document or any attachments, other than these statements 
and attachments submitted in accordance with paragraph (c)(3) of this 
section, will be recognized as asserting a claim of confidentiality. The 
format of data submissions is set forth in Sec. 158.32.
    (i) No claim of confidentiality.
    No claim of confidentiality, on any basis whatsoever, is made for 
any information contained in this document. I acknowledge that 
information not designated as within the scope of FIFRA sec. 
10(d)(1)(A), (B), or (C) and which pertains to a registered or 
previously registered pesticide is not entitled to confidential 
treatment and may be released to the public, subject to the provisions 
regarding disclosure to multinational entities under FIFRA sec. 10(g).
    (ii) Claim of confidentiality.
    Information claimed as confidential has been removed to a 
confidential attachment.
    (3) Confidential attachment. (i) All information claimed as 
confidential must be submitted in a separate confidential attachment to 
the document and cross referenced to the specific location in the 
document from which it was removed. The confidential attachment must 
have its own title page and be paginated separately from the non-
confidential document.
    (ii) All information in the confidential attachment that consists of 
(or whose disclosure would in turn disclose) manufacturing or quality 
control processes must be individually identified in the confidential 
attachment as a claim for information within the scope of FIFRA sec. 
10(d)(1)(A).
    (iii) All information in the confidential attachment that consists 
of (or whose disclosure would in turn disclose) the details of any 
methods for testing, detecting, or measuring the quantity of any 
deliberately added inert ingredient of a pesticide, must be individually 
identified in the confidential attachment as a claim for information 
within the scope of FIFRA sec. 10(d)(1)(B).
    (iv) All information in the confidential attachment that consists of 
(or whose disclosure would in turn disclose) the identity or percentage 
quantity of any deliberately added inert ingredient of a pesticide must 
be individually identified in the confidential attachment as a claim for 
information within the scope of FIFRA sec. 10(d)(1)(C).
    (v) Information in the confidential attachment that is designated in 
accordance with paragraphs (c)(3)(ii) - (iv) of this section must be on 
a separate page from information that is not so designated.
    (4) Voluntary release of information to States and foreign 
governments. (i) Submitters are encouraged to include with the statement 
required under paragraph (c)(2) of this section an additional statement 
to allow EPA to share information with State and foreign governments. 
EPA will not consider such a statement to be a waiver of confidentiality 
or proprietary claims for the information. The statement is as follows:
    I authorize the Environmental Protection Agency to release any 
information contained in this document to State or foreign governments, 
without relinquishing proprietary rights or any confidentiality claims 
asserted above.
    (ii) Information designated as releasable to state or foreign 
governments in accordance with this section may be released to such a 
government without further notice to the submitter. EPA will inform the 
State or foreign government of any of the confidentiality claims 
associated with the information.
    (d) Release of information. (1) Safety and efficacy information that 
was submitted to EPA on or after May 4, 1988 and that has not been 
designated by the submitter as FIFRA sec. 10(d)(1)(A), (B), or (C) 
information in accordance with the applicable requirements of this 
section is not entitled to confidential treatment and may be disclosed 
to the public without further notice to the submitter, in accordance 
with paragraph (d)(2) of this section. Safety and efficacy information 
which has been designated by the submitter as FIFRA sec. 10(d)(1) (A), 
(B), or (C) information is entitled to confidential treatment only to 
the extent provided by FIFRA sec. 10(b), this section, and 40 CFR 2.208.

[[Page 93]]

    (2) Information that is not entitled to be protected as confidential 
in accordance with FIFRA sec. 10(b), this section and with EPA 
confidentiality regulations at 40 CFR part 2, subpart B, may be released 
to the public without the affirmation of non-multinational status 
provided under FIFRA sec. 10(g), provided that the information does not 
contain or consist of any complete unpublished report submitted to EPA, 
or excerpts or restatements of any such report which reveal the full 
methodology and complete results of the study, test, or experiment, and 
all explanatory information necessary to understand the methodology or 
interpret the results.



Sec. 158.34  Flagging of studies for potential adverse effects.

    (a) Any applicant who submits a study of a type listed in paragraph 
(b) of this section must submit with the study a statement in accordance 
with paragraph (c) of this section.
    (b) The following table indicates the 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 paragraph 
(c) of this section when any criterion is met or exceeded.

                                            Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
                                                                    Criteria: Treated animals show     Criteria
                 Study Type(s)                    Guideline No.         any of the following:            No.
----------------------------------------------------------------------------------------------------------------
Carcinogenicity or combined carcinogenicity/           870.4200   An incidence of neoplasms in                 1
 chronic feeding study                                 870.4300    males or females which increases
                                                                   with dose (positive trend p<=
                                                                   0.05); or
 
                                                                  A statistically significant                  2
                                                                   (pairwise p<= 0.05) increase of
                                                                   any type of neoplasm in any test
                                                                   group, males or females at any
                                                                   dose level, compared to
                                                                   concurrent control animals of
                                                                   the same sex; or
 
                                                                  An increase in any type of                   3
                                                                   uncommon or rare neoplasms in
                                                                   any test group, males or females
                                                                   animals at any dose level,
                                                                   compared to concurrent controls
                                                                   of the same sex; or
 
                                                                  A decrease in the time to                    4
                                                                   development of any type of
                                                                   neoplasms in any test group,
                                                                   males or females at any dose
                                                                   level, compared to concurrent
                                                                   controls of the same sex.
----------------------------------------------------------------------------------------------------------------
Prenatal developmental toxicity                        870.3700   When compared to concurrent                  5
Reproduction and fertility.....................        870.3800    controls, treated offspring show
Developmental neurotoxicity....................        870.6300    a dose-related increase in
                                                                   malformations, pre- or post-
                                                                   natal deaths, or persistent
                                                                   functional or behavioral changes
                                                                   on a litter basis in the absence
                                                                   of significant maternal toxicity
                                                                   at the same dose level.
----------------------------------------------------------------------------------------------------------------
Neurotoxicity                                          870.6100   When compared to concurrent                  6
                                                       870.6200    controls, treated animals show a
                                                                   statistically or biologically
                                                                   significant increase in
                                                                   neuropathological lesions or
                                                                   persistent functional or
                                                                   behavioral changes.
----------------------------------------------------------------------------------------------------------------
Chronic feeding                                        870.4100   The no observed adverse effect               7
Carcinogenicity................................        870.4200    level (NOAEL) from one of these
Reproduction and fertility.....................        870.3800    studies is less than the NOAEL
Prenatal developmental toxicity................        870.3700    currently used by the Agency as
Developmental neurotoxicity....................        870.6300    the basis for either the acute
Acute or 90-day neurotoxicity..................        870.6200    or chronic reference dose.
----------------------------------------------------------------------------------------------------------------

    (c) Identification of studies. For each study of a type identified 
in paragraph (b) of this section, the applicant 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) Study does not meet or exceed criteria.
    I have applied the criteria of 40 CFR 158.34 for flagging studies 
for potential adverse effects to the results of the attached study.

[[Page 94]]

This study neither meets nor exceeds any of the applicable criteria.

    (2) Study meets or exceeds criteria.
    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].



Sec. 158.45  Waivers.

    (a) 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.
    (b)(1) Applicants are encouraged to discuss a data waiver request 
with the Agency before developing and submitting supporting data, 
information, or other materials.
    (2) All waiver requests must be submitted to the Agency in writing. 
The request must clearly identify the data requirement(s) for which a 
waiver is sought along with an explanation and supporting rationale why 
the applicant believes the data requirement should be waived. In 
addition, the applicant must describe any unsuccessful attempts to 
generate the required data, furnish any other information which the 
applicant(s) believe(s) would support the request, and when appropriate, 
suggest alternative means of obtaining data to address the concern which 
underlies the data requirement.
    (c) The Agency will review each waiver request and subsequently 
inform the applicant in writing of its decision. If the decision could 
apply to more than the requested product, the Agency, in its discretion, 
may choose to send a notice to all registrants or publish a notice in 
the Federal Register announcing the decision. An Agency decision denying 
a written request to waive a data requirement is a final Agency action.



Sec. 158.60  Minor use data policies.

    FIFRA sec. 2(ll) defines the term ``minor use''and FIFRA provides a 
number of statutory provisions concerning minor uses. In addition, EPA 
has established policies with respect to minor uses of pesticides, 
including, but not limited to, the following:
    (a) 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 registration.
    (b) EPA will accept appropriate and adequate extrapolations and 
regional data to support establishment of individual minor use 
tolerances.



Sec. 158.70  Satisfying data requirements.

    (a) General policy. The Agency will determine whether the data 
submitted or cited 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.
    (1) The provisions in this part 158 should be read in conjunction 
with the

[[Page 95]]

provisions in Sec. 152.85 to claim eligibility for the formulators' 
exemption.
    (2) [Reserved]
    (b) Good laboratory practices. Applicants must adhere to the good 
laboratory practice (GLP) standards described in 40 CFR part 160 when 
conducting studies. Applicants must also adhere to GLP standards when 
conducting a study in support of a waiver request of any data 
requirement which is within the scope of the GLP requirements.
    (c) Agency guidelines. EPA has published Test Guidelines that 
contain standards for conducting acceptable tests, guidance on the 
evaluation and reporting of data, definition of terms, and suggested 
study protocols. Copies of the Test Guidelines may be obtained by 
visiting the agency's website at www.epa.gov/pesticides.
    (d) Study protocols--(1) General. Any appropriate protocol may be 
used to generate the data required by this part, provided that it meets 
the purpose of the test standards specified in the pesticide assessment 
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.
    (2) Organization for Economic Co-Operation and Development (OECD) 
protocols. Tests conducted in accordance with the requirements and 
recommendations of the applicable OECD protocols can be used to develop 
data necessary to meet the requirements specified in this part. 
Applicants 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 
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.
    (e) Combining studies. Certain toxicology studies may be combined to 
satisfy data requirements. For example, carcinogenicity studies in rats 
may be combined with the rat chronic toxicity study. Combining 
appropriate studies may be expected to reduce usage of test animals as 
well as reduce the cost of studies. EPA encourages this practice by 
including standards for acceptable combined tests in the Pesticide 
Assessment Guidelines. Registrants and applicants are encouraged to 
consider combining other tests when practical and likely to produce 
scientifically acceptable results. Registrants and applicants, however, 
must consult with the EPA before initiating combined studies.



Sec. 158.75  Requirements for additional data.

    The data routinely required by this part 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 and effects of the 
pesticide.



Sec. 158.80  Use of other data.

    (a) Data developed in foreign countries. With certain exceptions, 
laboratory and field study data developed outside the United States may 
be submitted in support of a pesticide registration. Data generated in a 
foreign country which the Agency will not consider include, but are not 
limited to, 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. Applicants submitting foreign data 
must take steps to ensure that U.S. 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 
U.S. material or test site. Once submitted, the Agency will determine 
whether or not the data meet the data requirements.
    (b) Data generated for other purposes. Data developed for purposes 
other than satisfaction of FIFRA data requirements, such as monitoring 
studies,

[[Page 96]]

may also satisfy data requirements in this part. Consultation with the 
Agency should be arranged if applicants are unsure about suitability of 
such data.



                    Subpart B_How To Use Data Tables



Sec. 158.100  Pesticide use patterns.

    (a) General use patterns. There are six broad use categories used in 
the data tables. The six broad categories include terrestrial outdoor 
uses, aquatic outdoor uses, greenhouse uses, forestry uses, residential 
outdoor uses, and indoor uses of all types. The 6 broad use categories 
are further subdivided into 12 general use patterns which are the bases 
for data requirements established by use pattern. Within the data 
tables, general use patterns have been combined into single columns when 
the data requirements are the same for the combined uses. If there are 
no data requirements for a specific use, the column for that use is not 
included in the table. The 12 general use pattern groups used in the 
data table in this part are:
    (1) Terrestrial food crop use.
    (2) Terrestrial feed crop use.
    (3) Terrestrial nonfood crop use.
    (4) Aquatic food crop use.
    (5) Aquatic nonfood use.
    (6) Greenhouse food crop use.
    (7) Greenhouse nonfood crop use.
    (8) Forestry use.
    (9) Residential outdoor use.
    (10) Residential indoor use.
    (11) Indoor food use.
    (12) Indoor nonfood use.
    (b) Pesticide use site index. The Pesticide Use Site Index is a 
comprehensive list of specific pesticide use sites. The index is 
alphabetized separately by site for all agricultural and all 
nonagricultural uses. The Pesticide Use Site Index associates each 
pesticide use site with one or more of the 12 general use patterns. It 
may be used in conjunction with the data tables to determine the 
applicability of data requirements to specific uses. The Pesticide Use 
Site Index, which will be updated periodically, is available from the 
Agency or may be obtained from the Agency's website at http://
www.epa.gov/pesticides.
    (c) Applicants unsure of the correct use pattern for their 
particular product should consult the Agency.



Sec. 158.110  Required and conditionally required data.

    The tables in this part use the descriptors R (required), CR 
(conditionally required), and NR (not required) as a general indication 
of the applicability of a data requirement. In all cases, the test notes 
referred to in the table must be consulted to determine the actual 
applicability of the data requirement.
    (a) EPA requires data designated as ``required''(R) for products 
with a given use pattern in order to evaluate the risks or benefits of a 
product having that use pattern under any conditions established by the 
test notes.
    (b) Data designated as ``conditionally required'' (CR) for products 
with a given use pattern are required by EPA to evaluate the risks or 
benefits of a product having that use pattern if the product meets the 
conditions specified in the notes accompanying the requirement. 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 (for 
example, tier testing). Applicants must evaluate each applicable test 
note for the conditions and criteria to be considered in determining 
whether conditionally required data must be submitted.
    (c) Data not required for the Agency's assessment of the risks and 
benefits of a particular use pattern are designated ``not required'' 
(NR) in data tables.



Sec. 158.120  Determining data requirements.

    As with current practice, the actual data and studies required may 
be modified on an individual basis to fully characterize the use and 
properties of specific pesticide products under review. While EPA is 
attempting to assist the applicant in this subpart, it is important to 
emphasize that it is the applicant's obligation under FIFRA to 
demonstrate that an individual product meets the standard under FIFRA 
and/or FFDCA. Accordingly, applicants are

[[Page 97]]

encouraged to consult with the Agency on the appropriate data 
requirements as set forth here as they relate to their specific product 
prior to and during the registration process.
    (a) Finding the appropriate data table. (1) Pesticide data 
requirements for conventional chemical active ingredients and related 
substances are presented in subparts D, E, F, G, K, L, N, and O of this 
part in the form of a series of data tables, each addressing a 
particular scientific discipline or data topic. Data requirements for 
biochemical and microbial pest control agents are contained and are 
described separately within subparts U and V of this part, respectively.
    (2) Key to table notations. R = required data; CR = conditionally 
required data; NR = Not required; MP = manufacturing-use product; EP = 
end-use product; TEP = typical end-use product; TGAI = technical grade 
of the active ingredient; PAI = pure active ingredient; PAIRA = pure 
active ingredient, radiolabeled; Choice = choice of several test 
substances depending on studies required.
    (b) Identifying required studies. To determine the specific kinds of 
data needed to support the registration use of each pesticide product, 
the applicant may:
    (1) Refer to the applicable subpart(s) of this part. These subparts 
describe the data requirements including data tables for each subject 
area.
    (2) Select the general use pattern(s) that best cover the use 
pattern(s) specified on the pesticide product label as explained in 
Sec. 158.100. All applicable use patterns must be included.
    (3) Proceed down the appropriate general use pattern column in the 
table and note which tests are required (R), conditionally required 
(CR), or not required (NR). Required and conditionally required studies 
are described in Sec. 158.110.
    (4) Review the notes for each requirement to determine its 
applicability to the specific product proposed for registration.
    (5)(i) Proceed down the Test substance columns and determine the 
appropriate test substance needed for that study. If the data are 
intended to support a manufacturing-use product, use the MP column. If 
the data are intended to support an end-use product, use the EP column.
    (ii) The test substances columns specify which substance is to be 
used for testing. Applicants should note that the substance that must be 
used when performing the study may or may not be the product itself. For 
example, the data from a certain study may be required to support the 
registration of an end-use product, but the test substance column may 
state that the particular test shall be performed using the technical 
grade of the active ingredient(s) in the end-use product.
    (iii) Manufacturing-use products (MP) and end-use products (EP) 
containing a single active ingredient and no intentionally added inert 
ingredients are considered identical in composition to each other, and 
to the technical grade of the active ingredient (TGAI) from which they 
were derived. Therefore, the data from a test conducted using any one of 
these as the test substance is also suitable to meet the requirement (if 
any) for the same test to be conducted using either of the other 
substances.
    (6) Refer to the Pesticide Assessment Guideline reference number for 
each study located in the first column. See Sec. 158.70(c) for 
information pertaining to the guidelines and how to obtain copies.



Sec. 158.130  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) Product chemistry--(1) Product composition. Data on product 
composition are needed:
    (i) To support the conclusions expressed in the statement of 
formula;
    (ii) To compare to the composition of materials used in required 
testing under this part; and
    (iii) To determine whether a product is ``identical or substantially 
similar''to another product, a determination that involves the 
comparison of product composition.

[[Page 98]]

    (2) Nominal concentration and certified limits. The nominal 
concentration of a product, defined as that concentration that is 
expected to be present in a product as a result of the production or 
formulation process, is used to gauge the acceptability of the certified 
limits, which define the outer limits of the range of the product's 
ingredients. The certified limits are used to enforce the composition of 
the product and to ensure the accuracy of hazard assessments.
    (3) Physical and chemical characteristics. The physical and chemical 
characteristics of an active ingredient or product are used:
    (i) To confirm or provide supportive information on the identity and 
composition of the product;
    (ii) To assess the hazards of the ingredient or product; and
    (iii) To trigger or evaluate certain other studies required by this 
part.
    (c) Product performance. Requirements to develop data on product 
performance provide a mechanism to ensure that pesticide products will 
perform as intended 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.
    (d) Toxicology-humans and domestic animals. Data required to assess 
hazards to humans and domestic animals are derived from a variety of 
acute, subchronic 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 studies (usually conducted by 
feeding the test substance to the test species) 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 carcinogenicity 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) Developmental toxicity and reproduction studies. The 
developmental toxicity 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,

[[Page 99]]

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 prenatal developmental 
toxicity and serve as a guide for subsequent tests.
    (5) Mutagenicity studies. For each test substance a battery of tests 
is required to assess the 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, carcinogenicity, and, 
possibly, other health effects.
    (6) Metabolism studies. Data from studies on the absorption, 
distribution, metabolism, and excretion of a pesticide aid in the 
valuation of test results from other toxicity studies and in the 
extrapolation of data from animals to man. The main purpose of 
metabolism studies is to produce data which increases the Agency's 
understanding of the behavior of the chemical when considering the human 
exposure anticipated from intended uses of the pesticide.
    (e) Hazards to nontarget organisms--(1) General. The information 
required to assess hazards to nontarget organisms is 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 hierarchical or tier system which progresses from the basic 
laboratory tests to the applied field tests. The results of each tier of 
testing 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 determine 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, life cycle 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.
    (f) Applicator and post-application exposure. Data are used to 
evaluate exposures to persons in occupational and non-occupational 
settings, including agricultural, residential, commercial, institutional 
and recreational sites. Data include oral, dermal and inhalation 
exposure data, post-application residue data, post-application 
monitoring data, use information, and human activity information. These 
data, together with toxicology data, are used to determine whether 
application or post-application risks are of concern, and, where 
appropriate, to develop post-application restrictions such as reentry 
restrictions.
    (g) Pesticide spray drift evaluation. Data required to evaluate 
pesticide

[[Page 100]]

spray drift are derived from studies of droplet size spectrum and spray 
drift field evaluations. These data contribute to the 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) 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 
inadvertantly-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 crops and other food sources; and the loss of 
land as well as surface and ground water resources.
    (i) 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 the pesticide 
application, and results of tests 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.
    (4) 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.

[[Page 101]]

These data also provide information that aids the Agency in establishing 
any corresponding tolerances that would be needed for residues on such 
crops. Data from pesticide 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 shellfish. 
These residue data are also used to determine if a tolerance or action 
level is needed for residues in aquatic animals eaten by humans.



                   Subpart C_Experimental Use Permits



Sec. 158.200  Experimental use permit data requirements tables.

    Sections 158.200 through 158.270 describe how to use these tables to 
determine the experimental use permit data requirements for a particular 
pesticide product. Notes that apply to an individual test and include 
specific conditions, qualifications, or exceptions to the designated 
test are listed at the end of each table. Refer to 40 CFR part 172 for 
further information on experimental use permits.



Sec. 158.210  Experimental use permit data requirements for product 
chemistry.

    All product chemistry data, as described in Sec. 158.310, must be 
submitted to support a request for an experimental use permit.



Sec. 158.220  Experimental use permit data requirements for product
performance.

    All product performance data, as described in paragraph (c) of this 
section, must be submitted to support a request for an experimental use 
permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood crop. The greenhouse use pattern includes products 
classified under the general use patterns of greenhouse food crop and 
greenhouse nonfood crop. The indoor use pattern includes products 
classified under the general use patterns of indoor food and indoor 
nonfood use.
    (2) Data are also required for forestry and residential outdoor 
uses.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product.
    (c) Table. The following table shows the experimental use data 
requirements for product performance. The test notes are shown in 
paragraph (d) of this section.

[[Page 102]]



                                                                                                    Table--Experimental Use Permit Data Requirements for Product Performance
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                          Test substance to
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------         support
          Guideline No.             Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                           ------------------------  Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                                    No.
                                                            Food Crop           Nonfood Crop          Food Crop          Nonfood Crop          Food Crop         Nonfood Crop                              Outdoors                               MP          EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-8                             Products for         NR                   NR                   CR                   NR                  NR                  NR                  NR                  NR                  NR                        NR          EP           1
                                   treating water
                                   systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  93-16                            Products for         CR                   NR                   CR                   NR                  CR                  NR                  NR                  NR                  NR                        NR          EP           1
                                   control of
                                   organisms
                                   producing
                                   mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-5                             Avian toxicants      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-6                             Avian repellents     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-7                             Avian frightening    R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-9                             Bat toxicants and    NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  R                         NR          EP           1
                                   repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-10                            Commensal            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                        TEP          EP           1
                                   rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-12                            Rodenticides on      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   farm and
                                   rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-13                            Rodent fumigants     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-16                            Rodent               R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
                                   reproductive
                                   inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-17                            Mammalian            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 103]]

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. The Agency has waived the requirement 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 product is 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]

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.230  Experimental use permit data requirements for toxicology.

    All toxicology data, as described in paragraph (c) of this section, 
must be submitted to support a request for an experimental use permit.
    (a) Use patterns. (1) Food use patterns include products classified 
under the general use patterns of terrestrial food crop use, terrestrial 
feed crop use, aquatic food crop use, greenhouse food crop use, and 
indoor food use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use, aquatic nonfood 
crop use, aquatic nonfood outdoor use, greenhouse nonfood crop use, 
forestry use, residential outdoor use, indoor nonfood use, and indoor 
residential use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
EP=End-use product; MP=Manufacturing-use product; PAIRA=Pure active 
ingredient radio-labeled; TGAI=Technical grade of the active ingredient.
    (c) Table. The following table shows the experimental use data 
requirements for toxicology. The test notes are shown in paragraph (d) 
of this section.

                                                Table--Experimental Use Permit Toxicity Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Use Pattern                      Test substance to support
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------    Test Note No.
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1100                         Acute oral          R                   R                   MP and TGAI         TGAI, EP            1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1200                         Acute dermal        R                   R                   MP and TGAI         TGAI, EP            1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1300                         Acute inhalation    R                   R                   MP and TGAI         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2400                         Primary eye         R                   R                   MP                  TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2500                         Primary dermal      R                   R                   MP                  TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2600                         Dermal              R                   R                   MP                  TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                         Delayed             CR                  CR                  TGAI                TGAI                5
                                   neurotoxicity
                                   (acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3100                         90-day Oral -       R                   NR                  TGAI                TGAI               --
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3150                         90-day Oral - non-  R                   NR                  TGAI                TGAI                --
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 104]]

 
  870.4100                         Chronic oral -      R                   NR                  TGAI                TGAI                6
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3700                         Prenatal            R                   NR                  TGAI                TGAI                7, 8
                                   Developmental
                                   toxicity - rat
                                   and rabbit,
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3800                         Reproduction        R                   NR                  TGAI                TGAI                6
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5100                         Bacterial reverse   R                   NR                  TGAI                TGAI                9
                                   mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5300                         In vitro            R                   NR                  TGAI                TGAI                9, 10
  870.5375......................   mammalian cell
                                   assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5385                         In vivo             R                   NR                  TGAI                TGAI                9, 11
  870.5395......................   cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Not required if test material is a gas or a highly volatile 
liquid.
    2. Not required if test material is corrosive to skin or has a pH of 
less than 2 or greater than 11.5.
    3. Required if the product consists of, or under conditions of use 
will result in, a respirable material (e.g., gas, vapor, aerosol, or 
particulate).
    4. Required if repeated dermal exposure is likely to occur under 
conditions of use.
    5. Required if the test material is an organophosphorus substance, 
which includes uncharged organophosphorus esters, thioesters, or 
anhydrides of organophosphoric, organophosphonic, or 
organophosphoramidic acids, or of related phosphorothioic, 
phosponothioic, or phosphorothioamidic acids, or is structurally related 
to other substances that may cause the delayed neurotoxicity sometimes 
seen in this class of chemicals.
    6. These studies are seldom required to support EUPs. They may be 
required if the dietary exposure for these EUPs occupies a large part, 
e.g., greater than 50%, of the reference dose.
    7. The oral route, by oral intubation, is preferred unless the 
chemical or physical properties of the test substance or the pattern of 
exposure suggests a more appropriate route of exposure.
    8. May be combined with the 2-generation reproduction study in 
rodents by utilizing a second mating of the parental animals in either 
generation.
    9. At a minimum, an initial battery of mutagenicity tests with 
possible confirmatory testing is required. Other relevant mutagenicity 
tests that may have been performed, plus a complete reference list must 
also be submitted.
    10. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    11. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.240  Experimental use permit data requirements for ecological
effects.

    All data for terrestrial nontarget organisms and aquatic nontarget 
organisms as described in Sec. 158.243 must be submitted to support a 
request for an experimental use permit. No data for nontarget plant 
protection must be submitted to support a request for an experimental 
use permit.

[[Page 105]]



Sec. 158.243  Experimental use permit data requirements for terrestrial 
and aquatic nontarget organisms.

    All terrestrial and aquatic nontarget organism data, as described in 
paragraph (c) of this section, must be submitted to support a request 
for an experimental use permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood crop. The aquatic use 
pattern includes products classified under the general use patterns of 
aquatic food crop and aquatic nonfood. The greenhouse use pattern 
includes products classified under the general use patterns of 
greenhouse food crop and greenhouse nonfood crop. The indoor use pattern 
includes products classified under the general use patterns of indoor 
food and indoor nonfood use.
    (2) Data are also required for the general use patterns of forestry 
and residential outdoor use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
TEP=Typical end-use product; TGAI=Technical grade of the active 
ingredient; commas between the test substances (e.g. TGAI, TEP) indicate 
that data may be required on the TGAI or TEP depending on the conditions 
set forth in the test note.
    (c) Table. The following table shows the experimental use data 
requirements for terrestrial and aquatic nontarget organisms. The test 
notes are shown in paragraph (d) of this section.

                                                   Table--Experimental Use Permit Terrestrial and Aquatic Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
         Guideline No.          Data Requirement                                                           Residential                                         Test substance     Test Note No.
                                                     Terrestrial         Aquatic          Forestry           Outdoor         Greenhouse          Indoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2100                      Avian oral        R                 R                 R                 R                 CR                CR                TGAI              1, 2, 3
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2200                      Avian dietary     R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1075                      Freshwater fish   R                 R                 R                 NR                NR                NR                TGAI, TEP         1, 2, 5, 6, 11
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1010                      Acute toxicity    R                 R                 R                 NR                NR                NR                TGAI, TEP         1, 2, 6, 7, 11
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1300                      Aquatic           NR                R                 R                 NR                NR                NR                TGAI              1, 7, 8
                                 invertebrate
                                 life cycle
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   NR                R                 R                 NR                NR                NR                TGAI              1, 8, 9
                                 stage
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Accumulation Study
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1730                      Fish              CR                CR                CR                NR                NR                NR                TGAI or PAIRA     10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   850.3020                     Honeybee acute    R                 R                 R                 NR                NR                NR                TGAI              1
                                 contact
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Data using the TGAI are required to support all outdoor end-use 
product uses including, but not limited to, turf. Data are generally not 
required to support end-use products in the form of a gas, a highly 
volatile

[[Page 106]]

liquid, a highly reactive solid, or a highly corrosive material.
    2. For greenhouse and indoor end-use products, data using the TGAI 
are required to support manufacturing-use products to be reformulated 
into these same end-use products or to support end-use products when 
there is no registered manufacturing-use product. Avian acute oral data 
are not required for liquid formulations for greenhouse and indoor uses. 
The study is not required if there is no potential for environmental 
exposure.
    3. Data are required on one passerine species and either one 
waterfowl species or one upland game bird species for terrestrial, 
aquatic, forestry, and residential outdoor uses. Data are preferred on 
waterfowl or upland game bird species for indoor and greenhouse uses.
    4. Data are required on waterfowl and upland game bird species.
    5. Data are required on one coldwater fish and one warmwater fish 
for terrestrial, aquatic, forestry, and residential outdoor uses. For 
indoor and greenhouse uses, testing with only one of either fish species 
is required.
    6. EP or TEP testing is required for any product which meets any of 
the following conditions:
    i. The end-use pesticide will be introduced directly into an aquatic 
environment (e.g., aquatic herbicides and mosquito larvicides) when used 
as directed.
    ii. The maximum expected environmental concentration (MEEC) or the 
estimated environmental concentration (EEC) in the aquatic environment 
is >= one-half the LC50 or EC50 of the TGAI when 
the EP 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.
    7. Data are required on one freshwater aquatic invertebrate species.
    8. Data are generally not required for outdoor residential uses, 
other than turf, unless data indicate that pesticide residues from the 
proposed use(s) can potentially enter waterways.
    9. Data are required on one freshwater fish species. If the test 
species is different from the two species used for the freshwater fish 
acute toxicity tests, a 96 hour LC50 on that species must 
also be provided.
    10. Not required when:
    i. The octanol/water partition coefficients of the pesticide and its 
major degradates are < 1,000; or
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or
    iii. The hydrolytic half-life is < 5 days at pH 5, 7 and 9.
    11. The freshwater fish test species for the TEP testing is the most 
sensitive of the species tested with the TGAI. A freshwater invertebrate 
must also be tested with the EP or TEP using the same species tested 
with the TGAI.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.250  Experimental use permit data requirements for human 
exposure.

    No data for applicator exposure and post-application exposure must 
be submitted to support a request for an experimental use permit.



Sec. 158.260  Experimental use permit data requirements for 
environmental fate.

    All environmental fate data, as described in paragraph (c) of this 
section, must be submitted to support a request for an experimental use 
permit.
    (a) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes the general use patterns of aquatic food crop, aquatic nonfood 
residential, and aquatic nonfood outdoors. The greenhouse use pattern 
includes both food and nonfood uses. The indoor use pattern includes 
food, nonfood, and residential indoor uses.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (b) Key. CR=Conditionally required; NR=Not required; R=Required; 
PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the 
active ingredient.
    (c) Table. The following table shows the experimental use data 
requirements for environmental fate. The test notes are shown in 
paragraph (d) of this section.

[[Page 107]]



                                                               Table--Experimental Use Permit Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Use Pattern
                                                   -------------------------------------------------------------------------------------------------------------                      Test Note
         Guideline No.            Data Requirement                                                                                               Residential       Test substance        No.
                                                       Terrestrial        Aquatic        Greenhouse          Indoors            Forestry           Outdoors
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Degradation Study - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   835.2120                      Hydrolysis         R                            R   R                  NR                 R                  R                  TGAI or PAIRA                1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Metabolism Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   835.4100                      Aerobic soil       R                             CR NR                 NR                 R                  NR                 TGAI or PAIRA                2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4300                       Aerobic aquatic    NR                           R   NR                 NR                 NR                 NR                 TGAI or PAIRA               --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Mobility Study
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   835.1230                      Leaching and       R                           NR   NR                 NR                 R                  NR                 TGAI or PAIRA                3
  835.1240.....................   adsorption/
                                  desorption
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (c) of this section.
    1. Study is required for indoor uses in cases where environmental 
exposure is likely to occur. Such sites include, but are not limited to, 
agricultural premises, in or around farm buildings, barnyards, and 
beehives.
    2. Required for aquatic uses for aquatic sites that are 
intermittently dry. Such sites include, but are not limited to cranberry 
bogs and rice paddies.
    3. Adsorption and desorption using a batch equilibrium method is 
preferred. However, in some cases, for example, where the pesticide 
degrades rapidly, soil column leaching with unaged or aged columns may 
be more appropriate to fully characterize the potential mobility of the 
parent compound and major transformation products.

[72 FR 60957, Oct. 26, 2007, as amended at 73 FR 75596, Dec. 12, 2008]



Sec. 158.270  Experimental use permit data requirements for residue 
chemistry.

    All residue chemistry data, as described in Sec. 158.1410, are 
required for an experimental use permit for which a temporary tolerance 
under FFDCA section 408(r) is sought. Residue chemistry data are not 
required for an experimental use permit issued on a crop-destruct basis.



Sec. Sec. 158.280-158.290  [Reserved]



                       Subpart D_Product Chemistry



Sec. 158.300  Definitions.

    The following terms are defined for the purposes of this subpart:
    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, defoliant, or nitrogen stabilizer, within the 
meaning of FIFRA sec. 2(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, or as a nitrogen stabilizer, and
    (2) does not state that the product may be used to manufacture or 
formulate other pesticide products.
    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

[[Page 108]]

chemical reaction, to obtain a manufacturing-use product or an end-use 
product, or
    (2) The repackaging of any registered product.
    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.
    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.
    Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than the active 
ingredient, which is intentionally included in a pesticide product.
    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.
    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.
    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.
    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.
    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. 158.310  Product chemistry data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product chemistry data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (f) of the section.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use-specific.
    (c) Test substance. Data requirements that list only the 
manufacturing-use product as the test substance apply to products 
containing solely the technical grade of the active ingredient and 
manufacturing-use products to which other ingredients have been 
intentionally added.
    (d) Key. R=Required; CR=Conditionally required; MP=Manufacturing-use 
product; NR=Not required; EP=End-use product; TGAI=Technical grade of 
the active ingredient; PAI=Pure active ingredient.
    (e) Table. The following table shows the data requirements for 
product chemistry. The table notes are shown in paragraph (f) of this 
section.

                                       Product Chemistry Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                   Use Pattern       Test substance to support
       Guideline Number         Data Requirement --------------------------------------------------   Test Note
                                                       All             MP                EP              No.
----------------------------------------------------------------------------------------------------------------
Product Identity and Composition................................................................................
----------------------------------------------------------------------------------------------------------------
  830.1550                      Product identity            R   MP                EP                          1
                                 and composition
----------------------------------------------------------------------------------------------------------------

[[Page 109]]

 
   830.1600                     Description of              R   MP                EP                          2
                                 materials used
                                 to produce the
                                 product
----------------------------------------------------------------------------------------------------------------
   830.1620                     Description of              R   MP                EP                          3
                                 production
                                 process
----------------------------------------------------------------------------------------------------------------
   830.1650                     Description of              R   MP                EP                          4
                                 formulation
                                 process
----------------------------------------------------------------------------------------------------------------
   830.1670                     Discussion of               R   MP, and possibly  EP, and possibly            5
                                 formulation of                  TGAI              TGAI
                                 impurities
----------------------------------------------------------------------------------------------------------------
  830.1700                      Preliminary                  CR MP, and possibly  EP, and possibly     6, 9, 10
                                 analysis                        TGAI              TGAI
----------------------------------------------------------------------------------------------------------------
  830.1750                      Certified limits            R   MP                EP                          7
----------------------------------------------------------------------------------------------------------------
   830.1800                     Enforcement                 R   MP                EP                          8
                                 analytical
                                 method
----------------------------------------------------------------------------------------------------------------
   830.1900                     Submittal of                 CR MP, PAI and TGAI  EP, PAI, TGAI           9, 11
                                 samples
----------------------------------------------------------------------------------------------------------------
Physical and Chemical Properties................................................................................
----------------------------------------------------------------------------------------------------------------
  830.6302                      Color                       R   MP and TGAI       EP                          9
----------------------------------------------------------------------------------------------------------------
  830.6303                      Physical state              R   MP and TGAI       EP and TGAI                 9
----------------------------------------------------------------------------------------------------------------
   830.6304                     Odor                        R   MP and TGAI       EP                          9
----------------------------------------------------------------------------------------------------------------
   830.6313                     Stability to                R   MP and TGAI       EP                  9, 12, 26
                                 normal and
                                 elevated
                                 temperatures,
                                 metals, and
                                 metal ions
----------------------------------------------------------------------------------------------------------------
  830.6314                      Oxidation/                   CR MP                EP                         13
                                 reduction:
                                 chemical
                                 incompatibility
----------------------------------------------------------------------------------------------------------------
  830.6315                      Flammability                 CR MP                EP                         14
----------------------------------------------------------------------------------------------------------------
  830.6316                      Explodability                CR MP                EP                         15
----------------------------------------------------------------------------------------------------------------
  830.6317                      Storage                     R   MP                EP
                                 stability
----------------------------------------------------------------------------------------------------------------
  830.6319                      Miscibility                  CR MP                EP                         16
----------------------------------------------------------------------------------------------------------------
  830.6320                      Corrosion                   R   MP                EP
                                 characteristics
----------------------------------------------------------------------------------------------------------------
  830.6321                      Dielectric                   CR NR                EP                         17
                                 breakdown
                                 voltage
----------------------------------------------------------------------------------------------------------------
  830.7000                      pH                           CR MP and TGAI       EP and TGAI             9, 18
----------------------------------------------------------------------------------------------------------------
  830.7050                      UV/visible light            R   TGAI or PAI       NR                         --
                                 absorption
----------------------------------------------------------------------------------------------------------------
  830.7100                      Viscosity                    CR MP                EP                         19
----------------------------------------------------------------------------------------------------------------
  830.7200                      Melting point/              R   TGAI or PAI       TGAI or PAI             9, 20
                                 melting range
----------------------------------------------------------------------------------------------------------------
  830.7220                      Boiling point/              R   TGAI or PAI       TGAI or PA              9, 21
                                 boiling range
----------------------------------------------------------------------------------------------------------------
  830.7300                      Density/relative            R   MP and TGAI       EP and TGAI                 9
                                 density/bulk
                                 density
----------------------------------------------------------------------------------------------------------------
  830.7370                      Dissociation                R   TGAI or PAI       TGAI or PAI             9, 22
                                 constants in
                                 water
----------------------------------------------------------------------------------------------------------------
  830.7520                      Particle size,               CR TGAI or PAI       EP                         23
                                 fiber length,
                                 and diameter
                                 distribution
----------------------------------------------------------------------------------------------------------------
  830.7550                      Partition                   R   TGAI or PAI       TGAI or PAI                24
  830.7560....................   coefficient (n-
  830.7570....................   octanol/water)
----------------------------------------------------------------------------------------------------------------
  830.7840                      Water solubility            R   TGAI or PAI       TGAI or PAI                 9
  830.7860....................
----------------------------------------------------------------------------------------------------------------
   830.7950                     Vapor pressure              R   TGAI or PAI       TGAI or PAI             9, 25
----------------------------------------------------------------------------------------------------------------


[[Page 110]]

    (f) Test notes. The following test notes are applicable to the 
product chemistry data requirements in the table to paragraph (e) of 
this section:
    1. Data must be provided in accordance with Sec. 158.320.
    2. Data must be provided in accordance with Sec. 158.325.
    3. Data must be provided in accordance with Sec. 158.330.
    4. Data must be provided in accordance with Sec. 158.335.
    5. Data must be provided in accordance with Sec. 158.340.
    6. Data must be provided in accordance with Sec. 158.345.
    7. Data must be provided in accordance with Sec. 158.350.
    8. Data must be provided in accordance with Sec. 158.355.
    9. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI.
    10. Data are required if the product is produced by an integrated 
system.
    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.
    12. Data on the stability to metals and metal ions are required only 
if the TGAI is expected to come into contact with either material.
    13. Required when the product contains an oxidizing or reducing 
agent.
    14. Required when the product contains combustible liquids.
    15. Required when the product is potentially explosive.
    16. Required when the product is an emulsifiable liquid and is to be 
diluted with petroleum solvent.
    17. Required when the EP is a liquid and is to be used around 
electrical equipment.
    18. Required when the test substance is soluble or dispersible in 
water.
    19. Required when the product is a liquid.
    20. Required when the TGAI is solid at room temperature.
    21. Required when the TGAI is liquid at room temperature.
    22. Required when the test substance contains an acid or base 
functionality (organic or inorganic) or an alcoholic functionality 
(organic).
    23. Required for water insoluble test substances (>10-6 
g/l) and fibrous test substances with diameter of >=0.1 [micro]m.
    24. Required if technical chemical is organic and non-polar.
    25. Not required for salts.
    26. Data on stability of the MP and TGAI to storage at normal 
temperatures are required. Data on the stability of the TGAI to high 
temperatures are required if the TGAI is expected to be subjected to 
temperatures >50 [deg]C (122 [deg]F) during production or storage.



Sec. 158.320  Product identity and 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) of this section 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. 158.350.
    (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 (CAS) 
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 of the active ingredient in 
accordance with Sec. 158.350.
    (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

[[Page 111]]

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 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.
    (3) Upper and lower certified limits in accordance with Sec. 
158.350.
    (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 by EPA 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. 158.350.
    (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 >=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) The 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. 158.325  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, common 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 about each starting material used to produce the 
active ingredient, as follows:

[[Page 112]]

    (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 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. 158.330  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 about the formulation process, in accordance with 
Sec. 158.335.
    (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, and of 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. 158.335  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 158.330(b)(2), pertaining to characterization of the 
process.
    (b) Section 158.330(b)(4), pertaining to ingredients used in the 
process.
    (c) Section 158.330(b)(5), pertaining to process equipment.
    (d) Section 158.330(b)(6), pertaining to the conditions of the 
process.
    (e) Section 158.330(b)(8), pertaining to quality control measures.



Sec. 158.340  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

[[Page 113]]

would consider toxicologically significant may be present, the 
discussion must include an expanded discussion of the possible formation 
of the impurity and the amounts at which it might be present. The 
impurities which must also 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 registrant or applicant has reason 
to believe may be present in his product at any time before use at a 
level >=0.1 percent (1,000 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 the applicant 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 these 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 
>=0.1 percent (1,000 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 ingredient 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 on impurities:
    (1) From other possible chemical reactions.
    (2) Involving other ingredients.
    (3) At additional points in the production or formulation process.



Sec. 158.345  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 technical grade of the active 
ingredient. 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 substances are intended.
    (b) Based on the preliminary analysis, a statement of the 
composition of the technical grade of the active ingredient must be 
provided. If the technical grade of the active ingredient cannot

[[Page 114]]

be isolated, a statement of the composition of the practical equivalent 
of the technical grade of the active ingredient must be submitted.



Sec. 158.350  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. If the product label bears a 
statement prohibiting use after a certain date, 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 standard 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.

                        Standard Certified Limits
------------------------------------------------------------------------
If the nominal concentration (N)       The certified limits for that
     for the ingredient and           ingredient will be as follows:
  percentage by weight 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 applicants 
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 or 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 registrant or applicant of its determination and will provide 
supporting reasons. The Agency 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.

[[Page 115]]

    (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 [insert product name], EPA Reg. No. 
[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. 158.355  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 the Agency determines to be toxicologically 
significant.



                      Subpart E_Product Performance



Sec. 158.400  Product performance data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product performance data requirements for a 
particular pesticide product. Notes that apply to an individual test, 
including specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood. The greenhouse use pattern includes products classified 
under the general use patterns of greenhouse food crop and greenhouse 
nonfood crop. Data are also required for the general use patterns of 
forestry use, residential outdoor use, and indoor use, which includes 
both food and nonfood uses.
    (c) Key. CR=Conditionally required; NR=Not required; R=Required; 
EP=End-use product; MP=Manufacturing-use product; TEP=Typical end-use 
product.
    (d) Table. The following table lists the data requirements that 
pertain to product performance. The table notes are shown in paragraph 
(e) of this section.

[[Page 116]]



                                                                                                                  Table--Product Performance Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                          Test substance to
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------         support
        Guideline Number            Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                           ------------------------  Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor                                    No.
                                                            Food Crop           Nonfood Crop             Food               Nonfood            Food Crop         Nonfood Crop                               Outdoor                               MP          EP
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-2                             Products for use     NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
                                   on hard surfaces
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-3                             Products requiring   NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
                                   confirmatory data
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-4                             Products for use     NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
                                   on fabrics and
                                   textiles
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-5                             Air sanitizers       NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-7                             Products for         NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
                                   control of
                                   microbial pests
                                   associated with
                                   human and animal
                                   wastes
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  91-8                             Products for         NR                   NR                   CR                   NR                  NR                  NR                  NR                  NR                  CR                        NR          EP           1
                                   treating water
                                   systems
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of fungicides and nematicides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   93-16                           Products for        CR                    NR                   CR                   NR                  CR                  NR                  NR                  NR                  NR                        NR          EP           1
                                   control of
                                   organisms
                                   producing
                                   mycotoxins
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of vertebrate control agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   96-5                            Avian toxicants      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-6                             Avian repellents     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-7                             Avian frightening    R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   agents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-9                             Bat toxicants and    NR                   NR                   NR                   NR                  NR                  NR                  NR                  NR                  R                         NR          EP           1
                                   repellents
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-10                            Commensal            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                        TEP          EP           1
                                   rodenticides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  96-12                            Rodenticides on      R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   farm and
                                   rangelands
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 117]]

 
  95-13                            Rodent fumigants     R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-16                            Rodent               R                    R                    NR                   NR                  NR                  NR                  NR                  R                   R                         NR          EP           1
                                   reproductive
                                   inhibitors
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  95-17                            Mammalian            R                    R                    NR                   NR                  NR                  NR                  NR                  R                   NR                        NR          EP           1
                                   predacides
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 118]]

    (e) Test notes. The following notes appy to the data requirements 
table in paragraph (d) of this section.
    1. The Agency has waived the requirement to submit product 
performance 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 product is 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 product performance data for any pesticide product 
registered or proposed for registration.
    2. [Reserved]



                          Subpart F_Toxicology



Sec. 158.500  Toxicology data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
the data table in paragraph (d) of this section to determine the 
toxicology data requirements for a particular pesticide product. Notes 
that apply to an individual test and include specific conditions, 
qualifications, or exceptions to the designated test in the table are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Food use patterns include products classified 
under the general use patterns of terrestrial food crop use, terrestrial 
feed crop use, aquatic food crop use, greenhouse food crop use, and 
indoor food use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use, aquatic nonfood 
use, greenhouse nonfood crop use, forestry use, residential outdoor use, 
and indoor nonfood use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; 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 study required.
    (d) Table. The following table lists the toxicology data 
requirements. The table notes are shown in paragraph (e) of this 
section.

                                                           Table--Toxicology Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Use Pattern                      Test substance to support
        Guideline Number           Data Requirements --------------------------------------------------------------------------------    Test Note No.
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1100                        Acute oral          R                   R                    TGAI and MP        TGAI, EP, and       1, 2
                                   toxicity - rat                                                                  possibly diluted
                                                                                                                   EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1200                        Acute dermal        R                   R                   TGAI and MP         TGAI, EP            1, 2, 3
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.1300                        Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         4
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2400                        Primary eye         R                   R                   TGAI and MP         TGAI and EP         3
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2500                        Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 3
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.2600                        Dermal              R                   R                   TGAI and MP         TGAI and EP         3, 5
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                        Delayed             CR                  CR                  TGAI                TGAI                6
                                   neurotoxicity
                                   (acute) - hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6200                        Acute               R                   R                   TGAI                TGAI                7
                                   neurotoxicity -
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 119]]

 
Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3100                        90-day Oral -       R                   CR                  TGAI                TGAI                8, 9
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3150                        90-day Oral - non-  R                   CR                  TGAI                TGAI                36
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3200                        21/28-day Dermal    R                   NR                  TGAI                TGAI and EP          10, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3250                        90-day Dermal       CR                  R                   TGAI                TGAI and EP         11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3465                        90-day Inhalation - CR                  CR                  TGAI                TGAI                13, 14
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6100                        28-day Delayed      CR                  CR                  TGAI                TGAI                6, 15
                                   neurotoxicity-hen
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6200                        90-day              R                   R                   TGAI                TGAI                7, 16
                                   Neurotoxicity -
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.4100                        Chronic oral -      R                   CR                  TGAI                TGAI                17, 18, 19
                                   rodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.4200                        Carcinogenicity -   R                   CR                  TGAI                TGAI                9, 17, 18, 19, 20,
                                   two rodent                                                                                          21
                                   species - rat and
                                   mouse preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
Developmental Toxicity and Reproduction
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3700                        Prenatal            R                   R                   TGAI                TGAI                22, 23, 24, 25, 26
                                   Developmental
                                   toxicity - rat
                                   and rabbit,
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.3800                        Reproduction and    R                   R                   TGAI                TGAI                26, 27, 29
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.6300                        Developmental       CR                  CR                  TGAI                TGAI                27, 28, 29
                                   neurotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5100                        Bacterial reverse   R                   R                   TGAI                TGAI                30
                                   mutation assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5300                        In vitro mammalian  R                   R                   TGAI                TGAI                30, 31
  870.5375......................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.5385                        In vivo             R                   R                   TGAI                TGAI                30, 32
  870.5395......................   cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7485                        Metabolism and      R                   CR                  PAI or PAIRA        PAI or PAIRA        33
                                   pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7200                        Companion animal    CR                  CR                  NR                  TGAI or EP          34
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7600                        Dermal penetration  CR                  CR                  Choice              Choice              35
--------------------------------------------------------------------------------------------------------------------------------------------------------
  870.7800                        Immunotoxicity      R                   R                   TGAI                TGAI
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the requirements 
in the table to paragraph (d) of this section:
    1. Not required if test material is a gas or a highly volatile 
liquid.
    2. Diluted EP testing is required to support the end product 
registration if results using the EP meet the criteria for restricted 
use classification under Sec. 152.170(b) or special review 
consideration under Sec. 154.7(a)(1).
    3. Not required if the test material is corrosive to skin or has a 
pH of less than 2 or greater than 11.5.
    4. Required if the product consists of, or under conditions of use 
will result in, a respirable material (e.g., gas, vapor, aerosol, or 
particulate).

[[Page 120]]

    5. Required if repeated dermal exposure is likely to occur under 
conditions of use.
    6. Required if the test material is an organophosphorus substance, 
which includes uncharged organophosphorus esters; thioesters or 
anhydrides of organophosphoric, organophosphonic, or 
organophosphoramidic acids; or of related phosphorothioic, 
phosponothioic, or phosphorothioamidic acids; or is structurally related 
to other substances that may cause the delayed neurotoxicity sometimes 
seen in this class of chemicals.
    7. As determined by the Agency, additional measurements may also be 
required, such as cholinesterase activity for certain pesticides, e.g., 
organophosphates and some carbamates. The route of exposure must 
correspond with the primary route of exposure.
    8. Required for nonfood use pesticides if oral exposure could occur.
    9. The 90-day study is required in the rat for hazard 
characterization (possibly endpoint selection) and dose-setting for the 
chronic/carcinogenicity study. It is not required in the mouse, but the 
Agency would strongly encourage the registrant to conduct a 90-day range 
finding for the purposes of dose selection for the mouse carcinogenicity 
study to achieve adequate dosing and an acceptable study. The registrant 
is also encouraged to consult with the Agency on the results of the 90-
day mouse study prior to conducting the carcinogenicity study.
    10. Required for agricultural uses or if repeated human dermal 
exposure may occur. Not required if an acceptable 90-day dermal toxicity 
study is performed and submitted.
    11. EP testing is required if the product, or any component of it, 
may increase dermal absorption of the active ingredient(s) as determined 
by testing using the TGAI, or increase toxic or pharmacologic effects.
    12. Required for food uses if either of the following criteria is 
met:
    (i) The use pattern is such that the dermal route would be the 
primary route of exposure; or
    (ii) The active ingredient is known or expected to be metabolized 
differently by the dermal route of exposure than by the oral route, and 
a metabolite is the toxic moiety.
    13. Required if there is the likelihood of significant repeated 
inhalation exposure to the pesticide as a gas, vapor, or aerosol.
    14. Based on estimates of the magnitude and duration of human 
exposure, studies of shorter duration, e.g., 21- or 28-days, may be 
sufficient to satisfy this requirement. Registrants should consult with 
the Agency to determine whether studies of shorter duration would meet 
this requirement.
    15. Required if results of acute neurotoxicity study indicate 
significant statistical or biological effects, or if other available 
data indicate the potential for this type of delayed neurotoxicity, as 
determined by the Agency.
    16. All 90-day subchronic studies in rats can be designed to 
simultaneously fulfill the requirements of the 90-day neurotoxicity 
study using separate groups of animals for testing. Although the 
subchronic guidelines include the measurement of neurological endpoints, 
they do not meet the requirement of the 90-day neurotoxicity study.
    17. Required if either of the following are met:
    (i) The use of the pesticide is likely to result in repeated human 
exposure over a considerable portion of the human lifespan, as 
determined by the Agency;
    (ii) The use requires a tolerance or an exemption from the 
requirement of a tolerance.
    18. Based on the results of the acute and subchronic neurotoxicity 
studies, or other available data, a combined chronic toxicity and 
neurotoxicity study may be required.
    19. Studies which are designed to simultaneously fulfill the 
requirements of both the chronic oral and carcinogenicity studies (i.e., 
a combined study) may be conducted. Minimum acceptable study durations 
are:
    (i) Chronic rodent feeding study (food use) - 24 months.
    (ii) Chronic rodent feeding study (nonfood use) - 12 months.
    (iii) Mouse carcinogenicity study - 18 months.
    (iv) Rat carcinogenicity study - 24 months.
    20. Required if any of the following, as determined by the Agency, 
are met:
    (i) The use of the pesticide is likely to result in significant 
human exposure over a considerable portion of the human life span which 
is significant in terms of either frequency, duration, or magnitude of 
exposure;
    (ii) The use requires a tolerance or an exemption from the 
requirement of a tolerance; or
    (iii) The active ingredient, metabolite, degradate, or impurity (a) 
is structurally related to a recognized carcinogen, (b) causes mutagenic 
effects as demonstrated by in vitro or in vivo testing, or (c) produces 
a morphologic effect in any organ (e.g., hyperplasia, metaplasia) in 
subchronic studies that may lead to a neoplastic change.
    21. If this study is modified or waived, a subchronic 90-day oral 
study conducted in the same species may be required.
    22. Testing in two species is required for all uses.
    23. The oral route, by oral intubation, is preferred unless the 
chemical or physical properties of the test substance or the pattern of 
exposure suggests a more appropriate route of exposure.
    24. Additional testing by other routes may be required if the 
pesticide is determined to be a prenatal developmental toxicant after 
oral dosing.

[[Page 121]]

    25. May be combined with the 2-generation reproduction study in 
rodents by utilizing a second mating of the parental animals in either 
generation.
    26. Required to support products intended for food uses and to 
support products intended for nonfood uses if use of the product is 
likely to result in significant human exposure over a portion of the 
human life span in terms of frequency, magnitude or duration of 
exposure.
    27. An information-based approach to testing is preferred, which 
utilizes the best available knowledge on the chemical (hazard, 
pharmacokinetic, or mechanistic data) to determine whether a standard 
guideline study, an enhanced guideline study, or an alternative study 
should be conducted to assess potential hazard to the developing animal, 
or in some cases to support a waiver for such testing. Registrants 
should submit any alternative proposed testing protocols and supporting 
scientific rationale to the Agency prior to study initiation.
    28. Study required using a weight-of-evidence approach considering:
    (i) The pesticide causes treatment-related neurological effects in 
adult animal studies (i.e., clinical signs of neurotoxicity, 
neuropathology, functional or behavioral effects).
    (ii) The pesticide causes treatment-related neurological effects in 
developing animals, following pre- and postnatal exposure (i.e., nervous 
system malformations or neuropathy, brain weight changes in offspring, 
functional or behavioral changes in the offspring).
    (iii) The pesticide elicits a causative association between 
exposures and adverse neurological effects in human epidemiological 
studies.
    (iv) The pesticide evokes a mechanism that is associated with 
adverse effects on the development of the nervous system (e.g., SAR 
relationship to known neurotoxicants, altered neuroreceptor or 
neurotransmitter responses).
    29. The use of a combined study that utilizes the 2-generation 
reproduction study in rodents as a basic protocol for the addition of 
other endpoints or functional assessments in the immature animal is 
encouraged.
    30. At a minimum, an initial battery of mutagenicity tests with 
possible confirmatory testing is required. Other relevant mutagenicity 
tests that may have been performed, plus a complete reference list must 
also be submitted.
    31. Choice of assay using either:
    (i) Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    (ii) Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    (iii) CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    32. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.
    33. Required when chronic or carcinogenicity studies are required. 
May be required if significant adverse effects are seen in available 
toxicology studies and these effects can be further elucidated by 
metabolism studies.
    34. May be required if the product's use will result in exposure to 
domestic animals through, but not limited to, direct application.
    35. A risk assessment assuming that dermal absorption is equal to 
oral absorption must be performed to determine if the study is required, 
and to identify the doses and duration of exposure for which dermal 
absorption is to be quantified.
    36. A 1-year non-rodent study (i.e., 1-year dog study) would be 
required if the Agency finds that a pesticide chemical is highly 
bioaccumulating and is eliminated so slowly that it does not achieve 
steady state or sufficient tissue concentrations to elicit an effect 
during a 90-day study. EPA would require the appropriate tier II 
metabolism and pharmacokinetic studies to evaluate more precisely 
bioavailability, half-life, and steady state to determine if a longer 
duration dog toxicity study is needed.



Sec. 158.510  Tiered testing options for nonfood pesticides.

    For nonfood use pesticides only, applicants have two options for 
generating and submitting required toxicology (Sec. 158.500) and human 
exposure (Sec. 158.1020, Sec. 158.1070, and Sec. 158.1410) studies. 
Applicants are to select one of the following:
    (a) Acute, subchronic, chronic, and other toxicological studies on 
the active ingredient must be submitted together. The specific makeup of 
the set of toxicology study requirements is based on the anticipated 
exposure to the pesticide as determined by the Agency. If hazards are 
identified based upon review of these studies, specific exposure data 
will be required to evaluate risk.
    (b) Certain toxicological and exposure studies must be submitted 
simultaneously with the toxicology data submitted in a tiered system. 
Exposure data must be submitted along with

[[Page 122]]

first tier toxicology data. The requirement for additional second and 
third level toxicology testing will be determined by the Agency based on 
the results of the first tiered studies.
    (1) The required first-tier toxicology studies consist of:
    (i) Battery of acute studies.
    (ii) A subchronic 90-day dermal study or a subchronic 90-day 
inhalation study.
    (iii) An acute and subchronic neurotoxicity screening battery in the 
rat.
    (iv) Prenatal developmental toxicity studies in both the rat and 
rabbit.
    (v) Reproduction and fertility studies in rats.
    (vi) Battery of mutagenicity studies.
    (vii) Immunotoxicity study.
    (2) The conditionally required second-tier studies include:
    (i) Subchronic 90-day feeding studies in both the rodent and 
nonrodent.
    (ii) Dermal penetration study.
    (3) The conditionally required third-tier studies include:
    (i) Chronic feeding studies in the rodent.
    (ii) Carcinogenicity.
    (iii) Metabolism study.
    (iv) Additional mutagenicity testing.



                      Subpart G_ Ecological Effects



Sec. 158.630  Terrestrial and aquatic nontarget organisms data 
requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget data 
requirements for a particular pesticide product. Notes that apply to an 
individual test including specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of this 
section.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood crop. The aquatic use 
pattern includes products classified under the general use patterns of 
aquatic food crop and aquatic nonfood use patterns. The greenhouse use 
pattern includes products classified under the general use patterns of 
greenhouse food crop and greenhouse nonfood crop. The indoor use pattern 
includes products classified under the general use patterns of indoor 
food and indoor nonfood use.
    (2) Data are also required for the general use patterns of forestry 
and residential outdoor use.
    (3) In general, for all outdoor end-uses, including turf, the 
following studies are required: Two avian oral LD50, two 
avian dietary LC50, two avian reproduction studies, two 
freshwater fish LC50, one freshwater invertebrate 
EC50, one honeybee acute contact LD50, one 
freshwater fish early-life stage, one freshwater invertebrate life 
cycle, and three estuarine acute LC50/EC50 studies 
-- fish, mollusk and invertebrate. All other outdoor residential uses, 
i.e., gardens and ornamental will not usually require the freshwater 
fish early-life stage, the freshwater invertebrate life-cycle, and the 
acute estuarine tests.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product; PAI=Pure active ingredient; EP=end-use product. Commas between 
the test substances (i.e., TGAI, TEP) indicate that data may be required 
on the TGAI or the TEP depending on the conditions set forth in the test 
note.
    (d) Table. The following table shows the data requirements for 
nontarget terrestrial and aquatic organism. The table notes are shown in 
paragraph (e) of this section.

                                                                  Terrestrial and Aquatic Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data Requirement                                                           Residential                                         Test substance     Test Note No.
                                                     Terrestrial         Aquatic          Forestry           Outdoor         Greenhouse          Indoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and Mammalian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2100                      Avian oral        R                 R                 R                 R                 CR                CR                TGAI              1, 2, 3
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 123]]

 
  850.2200                      Avian dietary     R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2400                      Wild mammal       CR                CR                CR                CR                NR                NR                TGAI               5
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2300                      Avian             R                 R                 R                 R                 NR                NR                TGAI              1, 4
                                 reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.2500                      Simulated or      CR                CR                CR                CR                NR                NR                TEP               6, 7
                                 actual field
                                 testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1075                      Freshwater fish   R                 R                 R                 R                 CR                CR                TGAI, TEP         1, 2, 8, 9, 26
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1010                      Acute toxicity    R                 R                 R                 R                 CR                CR                TGAI, TEP         1, 2, 9, 10, 26
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1025                      Acute toxicity    R                 R                 R                 R                 NR                NR                TGAI, TEP         1, 9, 11, 12, 26
  850.1035....................   estuarine and
  850.1045....................   marine
  850.1055....................   organisms
  850.1075....................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1300                      Aquatic           R                 R                 R                  R                NR                NR                TGAI              1, 10, 12
                                 invertebrate
                                 life cycle
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1350                      Aquatic           CR                CR                CR                CR                NR                NR                TGAI              12, 14, 15
                                 invertebrate
                                 life cycle
                                 (saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   R                 R                 R                  R                NR                NR                TGAI              1, 12, 13
                                 stage
                                 (freshwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1400                      Fish early-life   CR                CR                CR                CR                NR                NR                TGAI              12, 15, 16
                                 stage
                                 (saltwater)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1500                      Fish life cycle   CR                CR                CR                CR                NR                NR                TGAI               17, 18
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1710                      Aquatic           CR                CR                CR                CR                NR                NR                TGAI, PAI,        19
  850.1730....................   organisms                                                                                                                     degradate
  850.1850....................   bioavailability
                                 ,
                                 biomagnificatio
                                 n, toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1950                      Simulated or      CR                CR                CR                CR                NR                NR                TEP               7, 20
                                 actual field
                                 testing for
                                 aquatic
                                 organisms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1735                      Whole sediment:   CR                CR                CR                CR                NR                NR                TGAI              21
                                 acute
                                 freshwater
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.1740                      Whole sediment:   CR                CR                CR                CR                NR                NR                TGAI              21, 23
                                 acute marine
                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 124]]

 
                                Whole sediment:   CR                CR                CR                 CR               NR                NR                TGAI              22, 23
                                 chronic
                                 invertebrates
                                 freshwater and
                                 marine
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3020                      Honeybee acute    R                 CR                R                 R                 NR                NR                TGAI              1
                                 contact
                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3030                      Honey bee         CR                CR                CR                CR                NR                NR                TEP                24
                                 toxicity of
                                 residues on
                                 foliage
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  850.3040                      Field testing     CR                CR                CR                CR                NR                NR                TEP                25
                                 for pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to terrestrial and 
aquatic nontarget organisms data requirements in the table to paragraph 
(d) of this section:
    1. Data using the TGAI are required to support all outdoor end-use 
product uses including, but not limited to turf. Data are generally not 
required to support end-use products in the form of a gas, a highly 
volatile liquid, a highly reactive solid, or a highly corrosive 
material.
    2. For greenhouse and indoor end-use products, data using the TGAI 
are required to support manufacturing-use products to be reformulated 
into these same end-use products or to support end-use products when 
there is no registered manufacturing-use product. Avian acute oral data 
are not required for liquid formulations for greenhouse and indoor uses. 
The study is not required if there is no potential for environmental 
exposure.
    3. Data are required on one passerine species and either one 
waterfowl species or one upland game bird species for terrestrial, 
aquatic, forestry, and residential outdoor uses. Data are preferred on 
waterfowl or upland game bird species for indoor and greenhouse uses.
    4. Data are required on waterfowl and upland game bird species.
    5. Tests are required based on the results of lower tier toxicology 
studies, such as the acute and subacute testing, intended use pattern, 
and environmental fate characteristics that indicate potential exposure.
    6. Higher tier testing may be required for a specific use pattern 
when a refined risk assessment indicates a concern based on laboratory 
toxicity endpoints and refined exposure assessments.
    7. Environmental chemistry methods used to generate data associated 
with this study must include results of a successful confirmatory method 
trial by an independent laboratory. Test standards and procedures for 
independent laboratory validation are available as addenda to the 
guideline for this test requirement.
    8. Data are required on one coldwater fish and one warmwater fish 
for terrestrial, aquatic, forestry, and residential outdoor uses. For 
indoor and greenhouse uses, testing with only one of either fish species 
is required.
    9. EP or TEP testing is required for any product which meets any of 
the following conditions:
    i. The end-use pesticide will be introduced directly into an aquatic 
environment (e.g., aquatic herbicides and mosquito larvicides) when used 
as directed.
    ii. The maximum expected environmental concentration (MEEC) or the 
estimated environmental concentration (EEC) in the aquatic environment 
is >= one-half the LC50 or EC50 of the TGAI when 
the EP 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.
    10. Data are required on one freshwater aquatic invertebrate 
species.
    11. Data are required on one estuarine/marine mollusk, one 
estuarine/marine invertebrate and one estuarine/marine fish species.
    12. Data are generally not required for outdoor residential uses, 
other than turf, unless data indicate that pesticide residues from the 
proposed use(s) can potentially enter waterways.

[[Page 125]]

    13. Data are required on one freshwater fish species. If the test 
species is different from the two species used for the freshwater fish 
acute toxicity tests, a 96-hour LC50 on that species must 
also be provided.
    14. Data are required on one estuarine/marine invertebrate species.
    15. Data are required on estuarine/marine species if the product 
meets any of the following conditions:
    i. Intended for direct application to the estuarine or marine 
environment.
    ii. Expected to enter this environment in significant concentrations 
because of its expected use or mobility patterns.
    iii. If the acute LC50 or EC50 < 1 milligram/
liter (mg/l).
    iv. If the estimated environmental concentration (EEC) in water is 
>= 0.01 of the acute EC50 or LC50 or if any of the 
following conditions exist:
    A. Studies of other organisms indicate the reproductive physiology 
of fish and/or invertebrates may be affected.
    B. Physicochemical properties indicate bioaccumulation of the 
pesticide.
    C. The pesticide is persistent in water (e.g., half-life in water > 
4 days).
    16. Data are required on one estuarine/marine fish species.
    17. Data are required on estuarine/marine species 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 patterns.
    18. Data are required on freshwater species if the end-use product 
is intended to be applied directly to water, or is expected to be 
transported to water from the intended use site, and when any of the 
following conditions apply:
    i. If the estimated environmental concentration (EEC) is >= 0.1 of 
the no-observed-effect level in the fish early-life stage or 
invertebrate life cycle test;
    ii. If studies of other organisms indicate that the reproductive 
physiology of fish may be affected.
    19. Not required when:
    i. The octanol/water partition coefficients of the pesticide and its 
major degradates are < 1,000; or
    ii. There are no potential exposures to fish and other nontarget 
aquatic organisms; or
    iii. The hydrolytic half-life is < 5 days at pH 5, 7 and 9.
    20. Data are required based on the results of lower tier studies 
such as acute and chronic aquatic organism testing, intended use 
pattern, and environmental fate characteristics that indicate 
significant potential exposure.
    21. Data are required if:
    i. The half-life of the pesticide in the sediment is <= 10 days in 
either the aerobic soil or aquatic metabolism studies and if any of the 
following conditions exist:
    A. The soil partition coefficient (Kd) is >= 50.
    B. The log Kow is >= 3.
    C. The Koc >= 1,000.
    ii. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.
    22. Data are required if:
    i. The estimated environmental concentration (EEC) in sediment is > 
0.1 of the acute LC50/EC50 values and
    ii. The half-life of the pesticide in the sediment is > 10 days in 
either the aerobic soil or aquatic metabolism studies and if any of the 
following conditions exist:
    A. The soil partition coefficient (Kd) is >= 50.
    B. The log Kow is >= 3.
    C. The Koc >= 1,000.
    iii. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.
    23. Sediment testing with estuarine/marine test species is 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 concentrations which the Agency believes to be significant, either by 
runoff or erosion, because of its expected use or mobility pattern.
    24. Data are required only when the formulation contains one or more 
active ingredients having an acute LD50 of < 11 micrograms 
per bee as determined in the honey bee acute contact study and the use 
pattern(s) indicate(s) that honey bees may be exposed to the pesticide.
    25. Required if any of the following conditions are met:
    i. Data from other sources (Experimental Use Permit program, 
university research, registrant submittals, etc.) indicate potential 
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 terrestrial arthropods other 
than bees indicate potential chronic, reproductive or behavioral 
effects.
    26. The freshwater fish test species for the TEP testing is the most 
sensitive of the species tested with the TGAI. Freshwater invertebrate 
and acute estuarine and marine organisms must also be tested with the EP 
or TEP using the same species tested with the TGAI.



Sec. 158.660  Nontarget plant protection data requirements table.

    (a) General. Sections 158.100 through158.130 describe how to use 
this table to determine the nontarget plant

[[Page 126]]

data requirements for a particular pesticide product. Notes that apply 
to an individual test and include specific conditions, qualifications, 
or exceptions to the designated test are listed in paragraph (e) of this 
section.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes only the general use patterns of aquatic food crops and aquatic 
nonfood.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; TEP=Typical end-use 
product.
    (d) Table. The following table shows the nontarget plant protection 
data requirements. The table notes are shown in paragraph (e) of this 
section.

                                                   Table--Nontarget Plant Protection Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Pattern
                                                     ------------------------------------------------------------
        Guideline Number           Data Requirement                                              Forestry and       Test substance       Test Note No.
                                                          Terrestrial           Aquatic           Residential
                                                                                                    Outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4100                         Seedling            R                   R                   R                   TEP                 1, 2, 7
                                   emergence
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4150                         Vegetative vigor    R                   R                   R                   TEP                 1, 2, 3, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4400                         Aquatic plant       R                   R                   R                   TEP or TGAI         1, 2, 7
  850.5400......................   growth (algal and
                                   aquatic vascular
                                   plant toxicity)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4100                         Seedling            CR                  CR                  CR                  TEP                 1, 4, 5, 7
                                   emergence
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4150                         Vegetative vigor    CR                  CR                  CR                  TEP                 1, 3, 4, 5, 7
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4400                         Aquatic plant       CR                  CR                  CR                  TEP or TGAI         1, 4, 6, 7
  850.5400......................   growth (algal and
                                   aquatic vascular
                                   plant toxicity)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget Area Phytotoxicity - Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4300                         Terrestrial field   CR                  CR                  CR                  TEP                 1, 7, 8, 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4450                         Aquatic field       CR                  CR                  CR                  TEP                 1, 7, 8, 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Target Area Phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  850.4025                         Target area         CR                  CR                  CR                  TEP                 1, 7, 9, 10
                                   phytotoxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the table in 
paragraph (d) of this section.
    1. Not required for contained pesticide treatments such as bait 
boxes and pheromone traps unless adverse effects reports are received by 
the Agency.
    2. Not required for known phytotoxicants.
    3. Generally not required for granular formulations. May be 
requested on a case-by-case basis.
    4. Required for known phytotoxicants such as herbicides, desiccants 
and defoliants.
    5. Required if a tested terrestrial species exhibits a 25 percent or 
greater detrimental effect in the Tier I study. When Tier II testing is 
required, the test species should be the species that showed detrimental 
effects in the Tier I testing.
    6. Required if the tested aquatic species exhibits a 50 percent or 
greater detrimental effect in the Tier I study. When Tier II testing is 
required, the test species should be the species that showed detrimental 
effects in the tier I testing.
    7. Not required for aquatic residential uses.
    8. Environmental chemistry methods used to generate data must 
include the results of a successful confirmatory method trial by an 
independent laboratory.

[[Page 127]]

    9. Tests are required on a case-by-case basis based on the results 
of lower tier phytotoxicity studies, adverse incident reports, intended 
use pattern, and environmental fate characteristics that indicate 
potential exposure.
    10. Registrants must consult with the Agency on appropriate test 
protocols prior to designing the study.



                         Subparts H	J [Reserved]



Sec. Sec. 158.700-158.900  [Reserved]



                        Subpart K_Human Exposure



Sec. 158.1000  Applicator exposure--general requirements.

    (a) If EPA determines that industrial standards, such as the 
workplace standards set by the Occupational Safety and Health 
Administration (OSHA), provide adequate protection from risk under FIFRA 
for a particular pesticide use pattern, exposure data may not be 
required for that use pattern. Applicants should consult with the Agency 
on appropriate testing prior to the initiation of studies.
    (b) The Agency may accept surrogate exposure data estimations from 
other sources to satisfy applicator exposure data requirements if the 
data meet the basic quality assurance, quality control, good laboratory 
practice, and other scientific requirements set by EPA. In order to be 
acceptable, the Agency must find that the surrogate exposure data 
estimations have adequate information to address applicator exposure 
data requirements and contain adequate replicates of acceptable quality 
data to reflect the specific use prescribed on the label and the 
applicator activity of concern, including formulation type, application 
methods and rates, type of activity, and other pertinent information. 
The Agency will consider using such surrogate data for evaluating human 
exposure on a case-by-case basis.



Sec. 158.1010  Applicator exposure--criteria for testing.

    Applicator exposure data described in paragraph (d) of this section 
are required based on toxicity and exposure criteria. Data are required 
if a product meets, as determined by the Agency, at least one of the 
toxicity criteria in paragraph (a) of this section and either or both of 
the exposure criteria in paragraph (b) of this section.
    (a) Toxicity criteria. (1) Evidence of potentially significant 
adverse effects have been observed in any applicable toxicity study.
    (2) Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from handling of 
the pesticide.
    (b) Exposure criteria. (1) Dermal exposure may occur during the 
prescribed use.
    (2) Respiratory exposure may occur during the prescribed use.



Sec. 158.1020  Applicator exposure data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the applicator exposure data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Occupational use patterns include products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, terrestrial nonfood crop, aquatic food, aquatic 
nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food 
use, and indoor nonfood use. Occupational use patterns also include 
commercial (``for hire'') applications to residential outdoor and indoor 
sites.
    (2) Residential use patterns include residential outdoor use and 
residential indoor use. These use patterns are limited to 
nonoccupational, i.e., nonprofessional, pesticide applications.
    (c) Key. R=Required; CR=Conditionally required; TEP=Typical end-use 
product.
    (d) Table. The data requirements listed pertain to pesticide 
products that meet the testing criteria outlined in Sec. 158.1010. The 
table notes are shown in paragraph (e) of this section.

[[Page 128]]



                                                      Table--Applicator Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use pattern
          Guideline Number              Data requirement    -----------------------------------------------     Test substance         Test Note No.
                                                                  Occupational            Residential
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                             Dermal outdoor          R                       R                      TEP                    1, 2, 3
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                             Dermal indoor exposure  R                       R                      TEP                    1, 2, 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                             Inhalation outdoor      R                       R                      TEP                    1, 2, 3
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                             Inhalation indoor       R                       R                      TEP                    1, 2, 4
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                             Biological monitoring   CR                      CR                     TEP                    1, 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1600                             Data reporting and      R                       R                      TEP                    5
                                      calculations
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1700                             Product use             R                       R                      TEP                    --
                                      information
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following notes apply to the data requirements 
in the table to paragraph (d) of this section:
    1. Protocols must be submitted for approval prior to the initiation 
of the study. Details for developing protocols are available from the 
Agency.
    2. Biological monitoring data may be submitted in addition to, or in 
lieu of, dermal and inhalation exposure data, provided the human 
pharmacokinetics of the pesticide and/or metabolite/analog compounds 
(i.e., whichever method is selected as an indicator of body burden or 
internal dose) allow for the back calculation to actual dose.
    3. Data are required if the product is applied outdoors.
    4. Data are required if the product is applied indoors.
    5. Data reporting and calculations are required when handler 
exposure data are submitted.



Sec. 158.1050  Post-application exposure--general requirements.

    (a) If EPA determines that industrial standards, such as the 
workplace standards set by the Occupational Safety and Health 
Administration, provide adequate protection for a particular pesticide 
use pattern, post-application exposure data may not be required for that 
use pattern. Applicants should consult with the Agency on appropriate 
testing before the initiation of studies.
    (b) The Agency may accept surrogate exposure data from other sources 
to satisfy post-application exposure data requirements if the data meet 
the basic quality assurance, quality control, good laboratory practice, 
and other scientific needs of EPA. In order to be acceptable, among 
other things, the Agency must find that the surrogate exposure data have 
adequate information to address post-application exposure data 
requirements and contain adequate replicates of acceptable quality data 
to reflect the specific use prescribed on the label and the post-
application activity of concern, including formulation type, application 
methods and rates, type of activity, and other pertinent information. 
The Agency will consider using such surrogate data for evaluating human 
exposure on a case-by-case basis.



Sec. 158.1060  Post-application exposure--criteria for testing

    Exposure data described in Sec. 158.1070(d) are required based upon 
toxicity and exposure criteria. Data are required if a product meets, as 
determined by the Agency, either or both of the toxicity criteria in 
paragraph (a) of this section and either or both of the exposure 
criteria in paragraph (b) of this section.
    (a) Toxicity criteria. (1) Evidence of potentially significant 
adverse health effects have been observed in any applicable toxicity 
study.
    (2) Scientifically sound epidemiological or poisoning incident data 
indicate that adverse health effects may have resulted from post-
application exposure to the pesticide.
    (b) Exposure criteria. The need for data from potential exposure 
resulting from situations not covered by this paragraph should be 
discussed with the Agency.
    (1) For outdoor uses. (i) Occupational human post-application 
exposure to

[[Page 129]]

pesticide residues on plants or in soil could occur as the result of 
cultivation, pruning, harvesting, mowing or other work-related activity. 
Such uses include agricultural food, feed, and fiber commodities, forest 
trees, ornamental plants, and turf grass.
    (ii) Residential human post-application exposure to pesticide 
residues on plants or in soil could occur. Such uses may include turf 
grass, fruits, vegetables, and ornamentals grown at sites, including, 
but not limited to, homes, parks, and recreation areas.
    (2) For indoor uses. (i) Occupational human post-application 
exposure to pesticide residues could occur following the application of 
the pesticide to indoor spaces or surfaces at agricultural or commercial 
sites, such as, but not limited to, agricultural animal facilities and 
industrial or manufacturing facilities.
    (ii) Residential human post-application exposure to pesticide 
residues could occur following the application of the pesticide to 
indoor spaces or surfaces at residential sites, such as, but not limited 
to homes, daycare centers, hospitals, schools, and other public 
buildings.



Sec. 158.1070  Post-application exposure data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the post-application data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Occupational use patterns include products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, terrestrial nonfood use, aquatic food, aquatic 
nonfood use, forestry, greenhouse food, greenhouse nonfood, indoor food, 
and indoor nonfood. Occupational use patterns also include commercial 
(``for hire'') applications to residential outdoor and indoor sites.
    (2) Residential use patterns include residential outdoor use and 
indoor residential use. These use patterns are limited to 
nonoccupational, i.e., nonprofessional, pesticide applications.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TEP=Typical end-use product.
    (d) Table. The data requirements listed in the following table 
pertain to pesticide products that meet the testing criteria outlined in 
Sec. 158.1060. The table notes are shown in paragraph (e) of this 
section.

                                                   Table--Post-Application Exposure Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Pattern
          Guideline Number              Data Requirement    -----------------------------------------------     Test Substance         Test Note No.
                                                                  Occupational            Residential
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2100                             Dislodgeable foliar     R                       R                      TEP                    1, 2, 3, 4, 5
                                      residue and turf
                                      transferable residues
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2200                             Soil residue            R                       CR                     TEP                    1, 2, 6, 7
                                      dissipation
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2300                             Indoor surface residue  R                       R                      TEP                    1, 2, 8, 9
                                      dissipation
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2400                             Dermal exposure         R                       R                      TEP                    1, 2, 10, 11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2500                             Inhalation exposure     R                       R                      TEP                    1, 10, 11, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2600                             Biological monitoring   CR                      CR                     TEP                    1, 12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2700                             Product use             R                       R                      TEP                    --
                                      information
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2800                             Description of human    R                       R                      TEP                    --
                                      activity
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.2900                             Data reporting and      R                       R                      TEP                    14
                                      calculations
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.3000                             Nondietary ingestion    NR                      R                      TEP                    1, 11, 15
                                      exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 130]]

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section:
    1. Protocols must be submitted for approval prior to the initiation 
of the study. Details for developing protocols are available from the 
Agency.
    2. Bridging applicable residue dissipation data to dermal exposure 
data is required.
    3. Turf grass transferable residue dissipation data are required 
when pesticides are applied to turf grass. Dislodgeable foliar residue 
dissipation data are required when pesticides are applied to the foliage 
of plants other than turf grass.
    4. Data are required for occupational sites if (i) there are uses on 
turf grass or other plant foliage, and (ii) the human activity data 
indicate that workers are likely to have post-application dermal contact 
with treated foliage while participating in typical activities.
    5. Data are required for residential sites if there are uses on turf 
grass or other plant foliage.
    6. Data are required for occupational sites, if (i) there are 
outdoor or greenhouse uses to or around soil or other planting media, 
and (ii) the human activity data indicate that workers are likely to 
have post-application dermal contact with treated soil or planting media 
while participating in typical activities.
    7. Data are required for residential sites if the pesticide is 
applied to or around soil or other planting media both outdoors and 
indoors, e.g., residential greenhouse or houseplant uses.
    8. Data are required for occupational sites if the pesticide is 
applied to or around on non-plant surfaces, e.g., flooring or 
countertops, and if the human activity data indicate that workers are 
likely to have post-application dermal contact with treated indoor 
surfaces while participating in typical activities.
    9. Data are required for residential sites if the pesticide is 
applied to or around non-plant surfaces, e.g., flooring and countertops.
    10. Data are required for occupational sites if the human activity 
data indicate that workers are likely to have post-application exposures 
while participating in typical activities.
    11. Data are required for residential sites if post-application 
exposures are likely.
    12. Biological monitoring data may be submitted in addition to, or 
in lieu of, dermal and inhalation exposure data provided the human 
pharmocokinetics of the pesticide and/or metabolite/analog compounds 
(i.e., whichever method is selected as an indicator of body burden or 
internal dose) allow for a back-calculation to the total internal dose.
    13. Data are required when passive dosimetry techniques are not 
applicable for a particular exposure scenario, such as a swimmer 
exposure to pesticides.
    14. Data reporting and calculations are required when any post-
application exposure monitoring data are submitted.
    15. The selection of a sampling method will depend on the nondietary 
pathway(s) of interest. Data must be generated to consider all potential 
pathways of nondietary ingestion exposure that are applicable (e.g., 
soil ingestion, hand-to-mouth transfer, and object-to-mouth transfer of 
surface residues).



                          Subpart L_Spray Drift



Sec. 158.1100  Spray drift data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the spray drift data requirements for a 
particular pesticide product. Notes that apply to an individual test, 
including specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop and 
terrestrial nonfood crop. The aquatic use pattern includes products 
classified under the general use patterns of aquatic food crop and 
aquatic nonfood. The greenhouse use pattern includes products classified 
under the general use patterns of greenhouse food crop and greenhouse 
nonfood crop. Data are also required for the general use patterns of 
forestry use, residential outdoor use, and indoor use.
    (c) Key. CR=Conditionally required; NR=Not required; TEP=Typical 
end-use product; MP=Manufacturing use product; EP=End-use product.
    (d) Table. The following table lists the data requirements that 
pertain to spray drift. The table notes are shown in paragraph (e) of 
this section.

[[Page 131]]



                                                                                                                      Table--Spray Drift Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Use Pattern                                                                                           Test substance
                                                      ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement                  Terrestrial                                Aquatic                                Greenhouse                                                                                                     Test Note
                                                      ---------------------------------------------------------------------------------------------------------------------------      Forestry           Residential           Indoor            MP          EP          No.
                                                            Food Crop           Nonfood Crop             Food               Nonfood            Food Crop         Nonfood Crop                               Outdoor
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  201-1                           Droplet size         CR                   CR                   CR                   CR                  NR                  NR                  CR                  NR                  NR                        TEP         TEP           1
                                   spectrum
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  202-1                           Droplet size         CR                   CR                   CR                   CR                  NR                  NR                  CR                  NR                  NR                        TEP         TEP           1
                                   spectrum
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 132]]

    (e) Test notes. The following notes apply to the requirements in the 
table to paragraph (d) 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.
    2. [Reserved]



                          Subpart M [Reserved]



Sec. Sec. 158.1200 -158.1299  [Reserved]



                      Subpart N_Environmental Fate



Sec. 158.1300  Environmental fate data requirements table.

    (a) General. All environmental fate data, as described in paragraph 
(c) of this section, must be submitted to support a request for 
registration.
    (b) Use patterns. (1) The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood. The aquatic use pattern 
includes the general use patterns of aquatic food crop, and aquatic 
nonfood. The greenhouse use pattern includes both food and nonfood uses. 
The indoor use pattern includes food, nonfood, and residential indoor 
uses.
    (2) Data are also required for the general use patterns of forestry 
use and residential outdoor use.
    (c) Key. CR=Conditionally required; NR=Not required; R=Required; 
PAIRA=Pure active ingredient radio-labeled; TGAI=Technical grade of the 
active ingredient; TEP=Typical end-use product.
    (d) Table. The following table shows the data requirements for 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                                           Table--Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                 ------------------------------------------------------------------------------------------------------------
       Guideline Number         Data Requirement                                                                                               Residential     Test substance     Test Note No.
                                                     Terrestrial         Aquatic         Greenhouse          Indoor           Forestry           Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2120                      Hydrolysis        R                 R                 R                 CR                R                 R                 TGAI or PAIRA     1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2240                      Photodegradation  R                 R                 NR                NR                R                 NR                TGAI or PAIRA     2
                                 in water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2410                      Photodegradation  R                 NR                NR                NR                R                 NR                TGAI or PAIRA     3
                                 on soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.2370                      Photodegradation  CR                NR                CR                NR                CR                CR                TGAI or PAIRA     4
                                 in air
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Metabolism Studies - Laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4100                      Aerobic soil      R                 CR                R                 NR                R                 R                 TGAI or PAIRA     5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4200                      Anaerobic soil    R                 NR                NR                NR                NR                NR                TGAI or PAIRA     --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4300                      Aerobic aquatic   R                 R                 NR                NR                R                 NR                TGAI or PAIRA     --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.4400                      Anaerobic         R                 R                 NR                NR                R                 NR                TGAI or PAIRA     --
                                 aquatic
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Mobility Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.1230                      Leaching and      R                 R                 R                 NR                R                 R                 TGAI or PAIRA     6
  835.1240....................   adsorption/
                                 desorption
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 133]]

 
  835.1410                      Volatility -      CR                NR                CR                NR                NR                NR                TEP               4
                                 laboratory
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.8100                      Volatility -      CR                NR                CR                NR                NR                NR                TEP               --
                                 field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Dissipation Studies - Field
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6100                      Terrestrial       R                 CR                NR                NR                CR                R                 TEP               5, 7, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6200                      Aquatic           CR                R                 NR                NR                NR                NR                TEP               7, 8
                                 (sediment)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6300                      Forestry          NR                NR                NR                NR                CR                NR                TEP               7, 9, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.6400                      Combination and   CR                CR                NR                NR                NR                NR                TEP               10
                                 tank mixes
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Ground Water Monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  835.7100                      Ground water      CR                NR                NR                NR                CR                CR                TEP               7, 9, 11
                                 monitoring
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the requirements 
in the table to paragraph (d) of this section:
    1. Study is required for indoor uses in cases where environmental 
exposure is likely to occur. Such sites include, but are not limited to, 
agricultural premises, in or around farm buildings, barnyards, and 
beehives.
    2. Not required when the electronic absorption spectra, measured at 
pHs 5, 7, and 9, of the chemical and its hydrolytic products, if any, 
show no absorption or tailing between 290 and 800 nm.
    3. Not required when the chemical is to be applied only by soil 
injection or is incorporated in the soil.
    4. Requirement based on use patterns and other pertinent factors 
including, but not limited to, the Henry's Law Constant of the chemical. 
In view of methodological difficulties with the study of 
photodegradation in air, prior consultation with the Agency regarding 
the protocol is recommended before the test is performed.
    5. Required for aquatic food and nonfood crop uses for aquatic sites 
that are intermittently dry. Such sites include, but are not limited to, 
cranberry bogs and rice paddies.
    6. Adsorption and desorption using a batch equilibrium method is 
preferred. However in some cases, for example, where the pesticide 
degrades rapidly, soil column leaching with unaged or aged columns may 
be more appropriate to fully characterize the potential mobility of the 
parent compound and major transformation products.
    7. Environmental chemistry methods used to generate data associated 
with this study must include results of a successful confirmatory method 
trial by an independent laboratory. Test standards and procedures for 
independent laboratory validation are available as addenda to the 
guideline for this test requirement.
    8. Requirement for terrestrial uses is based on potential for 
aquatic exposure and if pesticide residues have the potential for 
persistence, mobility, nontarget aquatic toxicity or bioaccumulation. 
Not required for aquatic residential uses. Field testing under the 
terrestrial field dissipation requirement may be more appropriate for 
some aquatic food crops, such as rice and cranberry uses, that are 
managed to have a dry-land period for production. The registrant is 
encouraged to consult with the Agency on protocols.
    9. Agency approval of a protocol is necessary prior to initiation of 
the study.
    10. This study may be triggered if there is specific evidence that 
the presence of one pesticide can affect the dissipation characteristics 
of another pesticide when applied simultaneously or serially.
    11. Required if the weight-of-evidence indicates that the pesticide 
and/or its degradates is likely to leach to ground water, taking into 
account other factors such as the toxicity of the chemicals(s), 
available monitoring data, and the vulnerability of ground water 
resources in the pesticide use area.
    12. If the terrestrial dissipation study cannot assess all of the 
major routes of dissipation, the forestry study will be required.

[[Page 134]]



                       Subpart O_Residue Chemistry



Sec. 158.1400  Definitions.

    The following terms are defined for the purposes of this subpart:
    Livestock, for the purposes of this section, includes all domestic 
animals that are bred for human consumption, including, but not limited 
to, cattle, swine, sheep, and poultry.
    Plant or animal metabolite means a pesticide chemical residue that 
is the result of biological breakdown of the parent pesticide within the 
plant or animal.
    Residue of concern means the parent pesticidal compound and its 
metabolites, degradates, and impurities of toxicological concern.
    Tolerance, for the purposes of this section, includes the 
establishment of a new tolerance or tolerance exemption, or amended 
tolerance or tolerance exemption.



Sec. 158.1410  Residue chemistry data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use.
    (2) Data may be required for nonfood uses if pesticide residues may 
occur in food or feed as a result of the use. Data requirements for 
these nonfood uses will be determined on a case-by-case basis. For 
example, most products used in or near kitchens require residue data for 
risk assessment purposes even though tolerances may not be necessary in 
all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
TGAI=Technical grade of the active ingredient; PAI=Pure active 
ingredient; PAIRA=Pure active ingredient radio-labeled; Residue of 
concern= the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; TEP=Typical end-use product.
    (d) Table. The following table list the data requirements for 
residue chemistry related to food uses. The table notes are shown in 
paragraph (e) of this section.

                                                                    Table--Residue Chemistry Data Requirements for Food Uses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                  Use Pattern
                                                     ----------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    Terrestrial Food                                                                   Residential       Test substance       Test Note No.
                                                            or Feed          Aquatic Food       Greenhouse Food       Indoor Food           Outdoor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                        Chemical identity   R                   R                   R                   R                   R                   TGAI                --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                        Directions for use  R                   R                   R                   R                   R                   --                  --
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                        Proposed tolerance  R                   R                   R                   CR                  NR                  --                  1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                        Reasonable grounds  R                   R                   R                   CR                  NR                  --                  1
                                   in support of
                                   petition
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                        Submittal of        R                   R                   R                   CR                  NR                  PAI and residue of  1, 2, 25
                                   analytical                                                                                                              concern
                                   reference
                                   standards
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                        Nature of the       R                   R                   R                   CR                  CR                  PAIRA               3, 4, 25
                                   residue in plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 135]]

 
  860.1300                        Nature of the       CR                  CR                  CR                  CR                  NR                  PAIRA or            1, 6, 25
                                   residue in                                                                                                              radiolabeled
                                   livestock                                                                                                               plant metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1850                        Confined            CR                  CR                  NR                  NR                  NR                  PAIRA               7
                                   rotational crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                        Residue analytical  R                   R                   R                   CR                  CR                  Residue of concern  1, 3, 8, 9, 10, 25
                                   methods
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                        Multiresidue        R                   R                   R                   CR                  NR                  Residue of concern  1, 11, 25
                                   method
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the residue
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1380                        Storage stability   R                   R                   R                   CR                  CR                  TEP or residue of   1, 3, 10, 12, 25
                                                                                                                                                           concern
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                        Crop field trials   R                   R                   R                   CR                  CR                  TEP                 3, 10, 14, 24, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                        Processed food or   CR                  CR                  CR                  CR                  NR                  TEP                 1, 15, 25
                                   feed
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                        Meat/milk/poultry/  CR                  CR                  CR                  CR                  NR                  TGAI or plant       1, 16, 17, 18, 25
                                   eggs                                                                                                                    metabolite
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Potable water       NR                  R                   NR                  NR                  NR                  TEP                 19, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Fish                NR                  R                   NR                  NR                  NR                  TEP                 5, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                        Irrigated crops     NR                  CR                  NR                  NR                  NR                  TEP                 20, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                        Food handling       NR                  NR                  NR                  CR                  NR                  TEP                 1, 21, 25
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                        Anticipated         CR                  CR                  CR                  CR                  NR                  Residue of concern  1, 13, 22, 26
                                   residues
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1900                        Field rotational    CR                  CR                  NR                  NR                  NR                  TEP                 23, 25
                                   crops
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data 
requirements in the table to paragraph (d) of this section.
    1. Required if indoor use could result in pesticide residues in or 
on food or feed.
    2. Material safety data sheets must accompany standards as specified 
by OSHA in 29 CFR 1910.1200.
    3. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    4. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    5. Data for fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited, by fish that may be caught 
or harvested for human consumption.

[[Page 136]]

    6. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed. If results from the plant metabolism study show 
differing metabolites in plants from those found in animals, an 
additional livestock metabolism study involving dosing with the plant 
metabolite(s) may also be required.
    7. Required when the Agency determines that it is reasonably 
foreseeable that a food or feed crop could be subsequently planted on 
the site of pesticide application after harvest or failure of the 
treated crop. Typically not required for pesticide uses in permanent 
food crops (e.g., various tree crops, vines) or semi-permanent crops 
(e.g., asparagus, pineapples).
    8. A residue analytical method suitable for enforcement purposes is 
required whenever a numeric tolerance (including temporary and time-
limited tolerances) is proposed.
    9. New analytical methods to be used for enforcement purposes must 
include results from an independent laboratory validation.
    10. A residue method, storage stability data, and crop field trials 
are required for the nonfood crop tobacco (green, freshly harvested). 
Depending on the level of residues found on the green tobacco, 
additional data may be required on cured/dried tobacco and pyrolysis 
products.
    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    12. Data are required for any magnitude of the residue study unless 
analytical samples are stored frozen for 30 days or less, and the active 
ingredient is not known to be volatile or labile.
    13. Studies using single serving samples of a raw agricultural 
commodity may be needed for acutely toxic pesticides and/or their 
metabolites. These residue studies must be conducted using a statistical 
design accepted by the Agency.
    14. Required for indoor uses which are direct postharvest treatments 
of raw agricultural commodities (e.g., fungicidal waxes or stored grain 
fumigants).
    15. Data on the nature and level of residues in processed food/feed 
are required if residues could potentially concentrate on processing 
thus requiring the establishment of a separate tolerance higher than 
that of the raw agricultural commodity.
    16. Required when the pesticide use is a direct application to 
livestock.
    17. Data are required if pesticide residues are present in or on 
livestock feed items or intentionally added to drinking water. These 
studies, however, may not be required in cases where the livestock 
metabolism studies indicate negligible transfer of the pesticide's 
residues of concern to tissues, milk, and eggs at the maximum expected 
exposure level for the animals.
    18. If results from the plant metabolism study show differing 
metabolites in plants from those found in animals, an additional 
livestock feeding study involving dosing with the plant metabolite(s) 
may also be required.
    19. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    20. Data 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.
    21. Data are required whenever a pesticide may be used in a food 
handling or feed handling establishment.
    22. Required when residues at the tolerance level may result in a 
risk of concern. These data may include washing, cooking, processing or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    23. Typically required if pesticide residues of concern greater than 
0.01 ppm are found in crops at the appropriate plant back intervals 
(taking into account plant back restrictions on product labels) in the 
confined rotational crop study. If residues of concern in the confined 
study are greater than 0.01 ppm but less than the limit of quantitation 
of the analytical method to be used on field trial samples, the Agency 
will consider not requiring, on a case-by-case basis, the limited field 
trials. If there are particular toxicological concerns with the parent 
pesticide or any metabolites, limited field studies may be needed if 
such residues are identified at levels below 0.01 ppm in the confined 
study.
    24. Crop field trials are required to establish tolerances on 
rotational crops when quantifiable residues of concern are observed in 
the field rotational crops study.
    25. Not required for an exemption from a tolerance provided that 
dietary exposure estimates are not needed due to low toxicity or that 
theoretical estimates of exposure are adequate to assess dietary risk.
    26. Not required for an exemption from a tolerance.



                         Subparts P	T [Reserved]



Sec. Sec. 158.1500-158.1900  [Reserved]



                    Subpart U_Biochemical Pesticides

    Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

[[Page 137]]



Sec. 158.2000  Biochemical pesticides definition and applicability.

    This subpart applies to all biochemical pesticides as defined in 
paragraphs (a), (b), and (c) of this section.
    (a) Definitions. The following terms are defined for the purposes of 
subpart U of this part.
    (1) A biochemical pesticide is a pesticide that:
    (i) Is a naturally-occurring substance or structurally-similar and 
functionally identical to a naturally-occurring substance;
    (ii) Has a history of exposure to humans and the environment 
demonstrating minimal toxicity, or in the case of a synthetically-
derived biochemical pesticides, is equivalent to a naturally-occurring 
substance that has such a history; and
    (iii) Has a non-toxic mode of action to the target pest(s).
    (2) A Pheromone is a compound produced by a living organism or is a 
synthetically derived substance that is structurally similar and 
functionally identical to a naturally-occurring pheromone, which, alone 
or in combination with other such compounds, modifies the behavior of 
other individuals of the same species.
    (i) An Arthropod Pheromone is a pheromone produced by a member of 
the taxonomic phylum Arthropoda.
    (ii) A Lepidopteran Pheromone is an arthropod pheromone produced by 
a member of the insect order Lepidoptera.
    (iii) A Straight Chain Lepidopteran Pheromone is a lepidopteran 
pheromone consisting of an unbranched aliphatic chain (between 9 and 18 
carbons) ending in an alcohol, aldehyde, or acetate functional group and 
containing up to three double bonds in the aliphatic backbone.
    (b) Examples. Biochemical pesticides include, but are not limited 
to:
    (1) Semiochemicals (insect pheromones and kairomones),
    (2) Natural plant and insect regulators,
    (3) Naturally-occurring repellents and attractants, and
    (4) Enzymes.
    (c) Applicability. The Agency may review, on a case-by-case basis, 
naturally-occurring pesticides that do not clearly meet the definition 
of a biochemical pesticide in an effort to ensure, to the greatest 
extent possible, that only the minimum testing sufficient to make 
scientifically sound regulatory decisions would be conducted. The Agency 
will review applications for registration of naturally-occurring 
pesticides to determine whether to review the pesticide under this 
subpart U.



Sec. 158.2010  Biochemical pesticides data requirements.

    (a) Sections 158.2030 through 158.2070 identify the data 
requirements that are required to support registration of biochemical 
pesticides. Sections 158.2080 through 158.2084 identify the data 
requirements that are required to support Experimental Use Permits 
(EUPs). Variations in the test conditions are identified within the test 
notes. Definitions that apply to all biochemical data requirements can 
be found in Sec. 158.2000.
    (b) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including food and nonfood 
uses for terrestrial and aquatic applications, greenhouse, indoor, 
forestry, and residential outdoor applications under certain 
circumstances.
    (c) The categories for each data requirement are ``R'', which stands 
for required, and ``CR'' which stands for conditionally required. 
Generally, ``R'' indicates that the data are more likely required than 
for those data requirements with ``CR.'' However, in each case, the 
regulatory text preceding the data table and the test notes following 
the data table must be used to determine whether the data requirement 
must be satisfied.
    (d) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or all of the above (All). 
Commas between the test substances (i.e., TGAI, EP) indicate that data 
may be required on the TGAI or

[[Page 138]]

EP or both depending on the conditions set forth in the test note.
    (e) The data requirements are organized into a tier-testing system 
with specified additional studies at higher tiers being required if 
warranted by adverse effects observed in lower tier studies. The lower 
tier studies are a subset of those required for conventional pesticides, 
and the studies overall are generally selected from those required for 
conventional pesticides.
    (f) Two sets of guideline numbers are provided for some of the 
environmental fate data requirements. For ease of understanding, the 
current guidelines will be used as an interim measure until the new 
guidelines (in parentheses) are finalized.



Sec. 158.2030  Biochemical pesticides product chemistry data 
requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular pesticide product. Notes that apply to an individual test 
and include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (e) of the section.
    (2) Definitions in Sec. 158.300 apply to data requirements in this 
section.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above.
    (d) Table. The following table shows the data requirements for 
biochemical pesticides product chemistry. The test notes are shown in 
paragraph (e) of this section.

                                            Table--Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 139]]

 
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are 
referenced in the last column of the table in paragraph (d) of this 
section.
    1. Data must be provided in accordance with Sec. 158.320.
    2. If the MP and EP are produced by an integrated formulation system 
(non-registered source), these data are also required on TGAI.
    3. Data must be provided in accordance with Sec. Sec. 158.325, 
158.330, and Sec. 158.335.
    4. Data must be provided in accordance with Sec. 158.340.
    5. Data must be provided in accordance with Sec. 158.345. Also, 
required to support the registration of each manufacturing-use product 
(including registered TGAIs) and end-use products produced by an 
integrated formulation system. Data on other end-use products would be 
required on a case-by-case basis.
    6. Data must be provided in accordance with Sec. 158.350.
    7. Data must be provided in accordance with Sec. 158.355.
    8. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI. EP testing may also be appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to be 
diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in 
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room 
temperature.
    14. Required when the technical chemical is a liquid at room 
temperature.
    15. Required for water insoluble test substances (>10-6g/
l) and fibrous test substances with diameter >=0.1 [micro]m.
    16. Required for organic chemicals unless they dissociate in water 
or are partially or completely soluble in water.
    17. Data on the stability to metals and metal ions is required only 
if the active ingredient is expected to come in contact with either 
material during storage.
    18. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs or EPs that are 
solid at room temperature.
    19. Not required for salts.



Sec. 158.2040  Biochemical pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e., naturally occurring insect repellents and

[[Page 140]]

attractants, semiochemicals (e.g., insect pheromones), natural and plant 
growth regulators. Notes that apply to an individual test and include 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may not 
be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data requirements table. The following table shows the data 
requirements for biochemical pesticides residue. The test notes are 
shown in paragraph (e) of this section.

                                             Table--Biochemical Residue Data Requirements for Specific Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Patterns
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test Notes
                                                ------------------------------------  Greenhouse Food    Indoor Food
                                                     Food/Feed           Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          CR                CR                CR                CR               TGAI             1, 2, 4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    CR                CR                CR                CR               --               1, 3, 4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI             1, 4, 5, 6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI or plant    1, 7, 8, 10, 13
                                residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                     Residue           CR                CR                R                 CR               Residue of       4, 9, 10
                                analytical                                                                               concern
                                method
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                     Multiresidue      CR                CR                R                 CR               Residue of       10, 11
                                method                                                                                   concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 15
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 141]]

 
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 10
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 16
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 10, 17
                                residues                                                                                 concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 18
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 10
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         10, 19
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are in the 
last column of the table contained in paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical human 
health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements, Sec. 158.2030, with an emphasis on 
impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest intervals, 
and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    5. Required unless it is an arthropod pheromone applied at a rate 
less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    7. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed.
    8. If results from the plant metabolism study show differing 
metabolites in plants from those found in animals, an additional 
livestock metabolism study involving dosing with the plant metabolite(s) 
may also be required.
    9. A residue analytical method suitable for enforcement of 
tolerances is required whenever a numeric tolerance (including temporary 
and time-limited tolerances) is proposed.
    10. Required if indoor use could result in pesticide residues in or 
on food or feed.
    11. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    12. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    13. Data on fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited by fish that may be caught 
or harvested for human consumption.
    14. Data 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.
    15. Data are required whenever a pesticide may be used in food/feed 
handling establishments.
    16. Data on the nature and level of residue in processed food/feed 
are required when detectible residues could potentially concentrate on 
processing thus requiring the establishment of a separate tolerance 
higher

[[Page 142]]

than that of the raw agricultural commodity.
    17. Required when residues at the tolerance level may result in risk 
of concern. These data may include washing, cooking, processing, or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    18. The proposed tolerance must reflect the maximum residue likely 
to occur in crops, in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.



Sec. 158.2050  Biochemical pesticides human health assessment data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the biochemical human health assessment data 
requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain 
lepidopteran pheromones when applied up to a maximum use rate of 150 
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include 
products classified under the following general uses: terrestrial food 
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse 
food crop use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood industrial 
use; greenhouse nonfood crop use; forestry use; residential outdoor use; 
residential indoor use; indoor food use; indoor nonfood use; indoor 
medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical pesticides human health assessment. The test notes are shown 
in paragraph (e) of this section.

                                         Table--Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600                          Dermal              R                   R                   TGAI and MP         TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 5
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   CR                  TGAI                TGAI                6
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 143]]

 
870.3250                          90-day dermal -     CR                  CR                  TGAI                TGAI                7
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation - CR                  CR                  TGAI                TGAI                8
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                9
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                10
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vitro mammalian  R                   CR                  TGAI                TGAI                10, 11
870.5375........................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          In vivo Mammalian   CR                  CR                  TGAI                TGAI                13
870.5895........................   Cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                9
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3550                          Immunotoxicity      CR                  CR                  TGAI                TGAI                12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Applicator/User Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                          Dermal outdoor      CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                          Dermal indoor       CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                          Inhalation outdoor  CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                          Inhalation indoor   CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                          Biological          CR                  CR                  TGAI                TGAI                15
                                   monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Chronic Testing/Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3800                          Immune response     CR                  CR                  TGAI                TGAI                14
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800                          Reproduction and    CR                  CR                  TGAI                TGAI                16
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100                          Chronic oral -      CR                  CR                  TGAI                TGAI                17
                                   rodent and
                                   nonrodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity -   CR                  CR                  TGAI                TGAI                18
                                   two species - rat
                                   and mouse
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5380                          Mammalian           CR                  CR                  TGAI                TGAI                19
                                   spermatogonial
                                   chromosome
                                   aberration test
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                          Companion animal    CR                  CR                  NR                  TGAI or EP          20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides human health assessment as 
referenced in the last column of the table in paragraph (d) of this 
section.

    1. Required unless the test material is a gas or highly volatile 
(vapor pressure >10-4torr (mm/Hg)).

[[Page 144]]

    2. Required unless the test material is corrosive to skin or has pH 
<2 or >11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or aerosol/
particulate), unless it is a straight chain lepidopteran pheromone.
    4. Required if repeated contact with human skin is likely to occur 
under conditions of use.
    5. Hypersensitivity incidents must be reported as adverse effects 
data.
    6. Required for non-food uses that are likely to result in repeated 
oral exposure to humans.
    7. Required to support uses involving purposeful application to the 
human skin or which would result in comparable prolonged human exposure 
to the product (e.g., insect repellents) and if any of the following 
criteria are met:
    i. Data from a 90-day oral study are not required.
    ii. The active ingredient is known or expected to be metabolized 
differently by the dermal route of exposure than by the oral route and 
the metabolite is of toxicological concern.
    iii. The use pattern is such that the dermal route would be the 
primary route of exposure.
    8. Required if there is a likelihood of significant levels of 
repeated inhalation exposure to the pesticide as a gas, vapor, or 
aerosol.
    9. Required if the use of the product under widespread and commonly 
recognized practice may reasonably be expected to result in significant 
exposure to female humans (e.g., occupational exposure or repeated 
application of insect repellents directly to the skin). Tier II data is 
required on a different test species from Tier I data when developmental 
effects are observed in the first study and information on species-to-
species extrapolation is needed.
    10. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of compounds 
containing a known mutagen. Additional mutagenicity tests that may have 
been performed plus a complete reference list must also be submitted. 
Subsequent testing may be required based on the available evidence.
    11. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vitro test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.
    12. Required if there are effects on hematology, clinical chemistry, 
lymphoid organ weights, and histopathology are observed in the 90-day 
studies.
    13. The micronucleus rodent bone marrow assay is preferred; however, 
rodent bone marrow assays using metaphase analysis (aberrations) are 
acceptable.
    14. Required if adverse effects are observed in the Tier II 
immunotoxicity study. The protocol for evaluating adverse effects to the 
immune response should be developed after evaluating the effects noted 
in the immunotoxicity study.
    15. These data are required when the data used for the human health 
assessment indicates that the biochemical may pose a potential hazard to 
the applicator/user.
    16. Required if there is evidence of:
    i. Endocrinological effects from the subchronic toxicity studies.
    ii. Developmental effects in the prenatal developmental toxicity 
study(s), or
    iii. Genotoxicity to mammals based on results from the mutagenicity 
tests.
The use of a combined study that utilizes the two-generation 
reproduction study in rodents (guideline 870.3800) as a basic protocol 
for the addition of other endpoints or functional assessments in the 
immature animal is encouraged.
    17. Required if the potential for adverse chronic effects is 
indicated based on any of the following:
    i. The subchronic effect level established in the following Tier I 
studies: 90-day oral toxicity study, 90-day dermal toxicity study, or 
90-day inhalation toxicity study.
    ii. The pesticide use pattern (e.g., rate, frequency, and site of 
application).
    iii. The frequency and level of repeated human exposure that is 
expected.
    18. Required if the product meets either of the following criteria:
    i. The active ingredient (or any of its metabolites, degradation 
products, or impurities) produce(s) in Tier I subchronic studies a 
morphologic effect (e.g., hyperplasia or metaplasia) in any organ that 
potentially could lead to neoplastic change.
    ii. Adverse cellular effects suggesting carcinogenic potential are 
observed in Tier II immunotoxicity and Tier III immune response study or 
in Tier II mammalian mutagenicity assays.
    In addition, a 90-day range finding study in both rats and mice is 
required to determine the dose levels if carcinogenicity studies are 
required. If the mouse carcinogenicity study is not required, the 90-day 
mouse subchronic study is likewise not required.

[[Page 145]]

    19. Required if results from lower tiered mutation or reproductive 
studies indicate there is potential for chromosomal aberration to occur.
    20. May be required if the product's use will result in exposure to 
domestic animals through, but not limited to, direct application or 
consumption of treated feed.



Sec. 158.2060  Biochemical pesticides nontarget organisms and 
environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, one acute freshwater invertebrate study, plant toxicity testing, 
and a honeybee acute contact study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be available 
to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include: forestry and residential outdoor use. Data are also required 
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
biochemical pesticides nontarget organisms and environmental fate. The 
test notes are shown in paragraph (e) of this section.

                                                   Table--Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   2, 3, 4, 5
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 146]]

 
850.1010                          Aquatic              R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........      2, 3, 5
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4100                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity, Seedling
                                   emergence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4150                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity,
                                   Vegetative vigor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Insect Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4350                          Nontarget Insect     R..................  R..................  R..................  R..................  NR.................  TGAI..............           14
                                   Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Environmental Fate Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1230)                  Sediment and soil    CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   adsorption/
                                   desorption for
                                   parent and
                                   degradates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1240)                  Soil column          CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-2 (835.1410)                  Laboratory           CR.................  NR.................  CR.................  CR.................  NR.................  TEP...............            7
                                   volatilization
                                   from soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.2120)                  Hydrolysis           CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.4100)                  Aerobic soil         CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-2 (835.2240)                  Photodegradation in  CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-3 (835.2410)                  Photodegradation on  CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-2 (835.4200)                  Anaerobic soil       CR.................  NR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-4 (835.4300)                  Aerobic aquatic      CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-3 (835.4400)                  Anaerobic aquatic    CR.................  CR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4425                          Dispenser - water    CR.................  NR.................  CR.................  CR.................  NR.................  EP................            8
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Seedling emergence   R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4250                          Vegetative vigor     R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Fauna Chronic, Life Cycle, and Field Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                          Freshwater fish/     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1400........................   invertebrate
850.1500........................   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 147]]

 
850.1025                          Marine/Estuarine     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1035........................   fish/invertebrate
850.1045........................   animal testing
850.1055........................
850.1350........................
850.1400........................
850.1500........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                          Aquatic field fish/  CR.................  CR.................  NR.................  CR.................  NR.................  EP................           10
                                   invertebrate
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Terrestrial Wildlife
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300                          Avian Reproduction   CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2400                          Wild mammal acute    CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                          Terrestrial field    CR.................  CR.................  NR.................  CR.................  NR.................  EP................           11
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Beneficial Insects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                          Field testing for    CR.................  CR.................  NR.................  CR.................  NR.................  TEP...............           12
                                   Pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Nontarget plant      CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           13
850.4250........................
850.4300........................
850.4450........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides nontarget organisms and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to support 
arthropod pheromones that would be available to avian wildlife, (e.g., a 
granular product).
    2. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern, physical/
chemical properties, production volume, and other pertinent factors.
    3. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility >5 X 10-5atm m\3\/mol).
    4. Preferred test species are Upland game, waterfowl, or passerine 
for avian acute oral toxicity studies; Upland game and waterfowl for 
avian dietary studies; and coldwater fish species for acute freshwater 
fish studies.
    5. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.
    6. Required on a case-by-case basis when results from Tier I studies 
indicate adverse effects.
    7. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied on land. In view 
of methdological difficulties with the study of photodegradation in air, 
prior consultation with the Agency regarding the protocol is recommended 
before the test is performed.
    8. Required when results of any one or more of the nontarget 
organism studies in Tier I indicate potential adverse effects on 
nontarget organisms and the pesticide is to be applied in a passive 
dispenser.
    9. Required to support registration of known phytotoxicants, i.e., 
herbicides, desiccants, defoliants, and plant growth regulators.
    10. Required if environmental fate characteristics indicate that the 
estimated environmental concentration of the pesticide in the aquatic 
environment is >0.01 of any EC50

[[Page 148]]

or LC50 determined in the aquatic nontarget organism testing.
    11. Required if either of the following criteria are met:
    i. Environmental fate characteristics indicate that the estimated 
concentration of the pesticide in the terrestrial environment is > 0.20 
the avian dietary LC50 or equal to > 0.20 the avian oral 
single dose LD50 (converted to ppm).
    ii. 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 or mammalian feed.
    12. Required when results of Tier I nontarget organism studies 
indicate potential adverse effects on nontarget insects and results of 
Tier II tests indicate exposure of nontarget insects. Additional insect 
species may have to be tested if necessary to address issues raised by 
use patterns and potential exposure of important nontarget insect 
species, (e.g., threatened or endangered species).
    13. Required if the product is expected to be transported from the 
site of application by air, soil, or water. The extent of movement would 
be determined by the results of the Tier II environmental fate studies.
    14. Required depending on pesticide mode of action, method and 
timing of application, and results of any available efficacy data. 
Typically the honeybee acute toxicity guideline (guideline 850.3020) 
satisfies this requirement, however, additional nontarget insect species 
may have to be tested if necessary to address issues raised by use 
patterns and potential exposure of important nontarget insect species, 
(e.g., endangered species.)



Sec. 158.2070  Biochemical pesticides product performance data 
requirements.

    Product performance data must be developed for all biochemical 
pesticides. However, the Agency typically does not require applicants to 
submit such efficacy data unless the pesticide product bears a claim to 
control public health pests, such as pest microorganisms infectious to 
man in any area of the inanimate environment or a claim to control 
vertebrates (including but not limited to: rodents, birds, bats, canids, 
and skunks) or invertebrates (including but not limited to: mosquitoes 
and ticks) 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.



Sec. 158.2080  Experimental use permit data requirements--biochemical
pesticides.

    (a) Sections 158.2081 through 158.2084 describe the experimental use 
permit (EUP) data requirements for biochemical pesticides. Variations in 
the test conditions are identified within the test notes. Definitions 
that apply to all biochemical data requirements can be found in Sec. 
158.2000.
    (b) For general information on the data requirement tables, see 
Sec. 158.2010(b)-(f).



Sec. 158.2081  Experimental use permit biochemical pesticides product
chemistry data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the product chemistry data requirements for 
a particular biochemical pesticide product. Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (e) of the 
section.
    (2) Depending on the results of the required product chemistry 
studies, appropriate use restrictions, labeling requirements, or special 
packaging requirements may be imposed.
    (b) Use patterns. Product chemistry data are required for all 
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental

[[Page 149]]

use permit biochemical pesticides product chemistry. The test notes are 
shown in paragraph (e) of this section.

                                          Table--EUP Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides product 
chemistry and are referenced in the last column of the table in 
paragraph (d) of this section.

[[Page 150]]

    1. Data must be provided in accordance with Sec. 158.320.
    2. If the MP and EP are produced by an integrated formulation system 
(non-registered source), these data are also required on TGAI.
    3. Data must be provided in accordance with Sec. 158.325, Sec. 
158.330, and Sec. 158.335.
    4. Data must be provided in accordance with Sec. 158.340.
    5. Data must be provided in accordance with Sec. 158.345. Also, 
required to support the registration of each manufacturing-use product 
(including registered TGAIs) and end-use products produced by an 
integrated formulation system. Data on other end-use products would be 
required on a case-by-case basis. For pesticides in the production 
stage, a preliminary product analytical method and data would suffice to 
support an experimental use permit.
    6. Data must be provided in accordance with Sec. 158.350.
    7. Data must be provided in accordance with Sec. 158.355.
    8. If the TGAI cannot be isolated, data are required on the 
practical equivalent of the TGAI. EP testing may also be appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to be 
diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in 
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room 
temperature.
    14. Required when the technical chemical is a liquid at room 
temperature.
    15. Required for water insoluble test substances (>10-6g/
l) and fibrous test substances with diameter >=0.1 [micro]m.
    16. Required for organic chemicals unless they dissociate in water 
or are partially or completely soluble in water.
    17. Data on the stability to metals and metal ions is required only 
if the active ingredient is expected to come in contact with either 
material during storage.
    18. True density or specific density are required for all test 
substances. Data on bulk density is required for MPs or EPs that are 
solid at room temperature.
    19. Not required for salts.



Sec. 158.2082  Experimental use permit biochemical pesticides residue 
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the biochemical pesticides residue data 
requirements for a particular pesticide product and the substance that 
needs to be tested. These data requirements apply to all biochemical 
pesticides, i.e., naturally occurring insect repellents and attractants, 
semiochemicals (e.g., insect pheromones), natural and plant growth 
regulators. Notes that apply to an individual test and include specific 
conditions, qualifications, or exceptions to the designated test are 
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required 
for all pesticides used in or on food and for residential outdoor uses 
where food crops are grown. Food use patterns include products 
classified under the general use patterns of terrestrial food crop use, 
terrestrial feed crop use, aquatic food crop use, greenhouse food crop 
use, and indoor food use. Data are also conditionally required for 
aquatic nonfood use if there is direct application to water that could 
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide 
residues may occur in food or feed as a result of the use. Data 
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require 
residue data for risk assessment purposes even though tolerances may not 
be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates,and 
impurities of toxicological concern. All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Data table. The following table shows the data requirements for 
biochemical pesticides residue. The test notes are shown in paragraph 
(e) of this section.

[[Page 151]]



                                               Table--EUP Biochemical Pesticides Residue Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Patterns
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test Notes
                                                ------------------------------------  Greenhouse Food    Indoor Food
                                                     Food/Feed           Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          CR                CR                CR                CR               TGAI             1, 2, 4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    CR                CR                CR                CR               --               1, 3, 4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI             1, 4, 5, 6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9, 13
                                residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 15
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 9, 16
                                residues                                                                                 concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 17
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 9
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         9, 18
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for biochemical pesticides product chemistry and are 
referenced referenced in the last column of the table contained in 
paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical 
pesticide products when Tier II or Tier III toxicology data are 
required, as specified for biochemical agents in the biochemical human 
health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical 
product chemistry data requirements,Sec. 158.2030 with an emphasis on 
impurities.
    3. Required information includes crops to be treated, rate of 
application, number and timing of applications, preharvest intervals, 
and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the 
corresponding agricultural use is not approved or the residential use is 
expected to produce higher residues based on the label directions.
    5. Required unless it is an arthropod pheromone applied at a rate 
less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied directly 
to food, in order to determine metabolites and/or degradates. Not 
required when only indirect contact with food would occur (e.g., crack 
and crevice treatments).
    7. Required when a pesticide is to be applied directly to livestock, 
to livestock premises, to livestock drinking water, or to crops used for 
livestock feed. If results from

[[Page 152]]

the plant metabolism study show differing metabolites in plants form 
those found in animals, an additional livestock metabolism study 
involving dosing with the plant metabolite(s) may also be required.
    8. Livestock feeding studies are required whenever a pesticide 
residue is present in livestock feed or when direct application to 
livestock uses occurs.
    9. Required if indoor use could result in pesticide residues in or 
on food or feed.
    10. Data are required to determine whether FDA/USDA multiresidue 
methodology would detect and identify the pesticides and any 
metabolites.
    11. Data are required whenever a pesticide may be applied directly 
to water, unless it can be demonstrated that the treated water would not 
be available for human or livestock consumption.
    12. Data on fish are required for all pesticides applied directly to 
water inhabited, or which will be inhabited, by fish that may be caught 
or harvested for human consumption.
    13. Data 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.
    14. Data are required whenever a pesticide may be used in food/feed 
handling establishments.
    15. Data on the nature and level of residue in processed food/feed 
are required when detectible residues could potentially concentrate on 
processing thus requiring the establishment of a separate tolerance 
higher than that of the raw agricultural commodity.
    16 Anticipated residue data are required when the assumption of 
tolerance level residues would result in predicted exposure at an unsafe 
level of exposure. Data, using single serving samples of a raw 
agricultural commodity, on the level or residue in food as consumed 
would be used to obtain a more precise estimate of potential dietary 
exposure. These data may also include washing, cooking, processing or 
degradation studies as well as market basket surveys for a more precise 
residue determination.
    17. The proposed tolerance must reflect the maximum residue likely 
to occur in crops, in meat, milk, poultry, or eggs.
    18. Required when a residue analytical method is required.



Sec. 158.2083  Experimental use permit biochemical pesticides human 
health assessment data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the human health assessment data 
requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain 
lepidopteran pheromones when applied up to a maximum use rate of 150 
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include 
products classified under the following general uses: terrestrial food 
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse 
food crop use.
    (2) Nonfood use patterns include products classified under the 
general use patterns of terrestrial nonfood crop use; aquatic nonfood 
residential use; aquatic nonfood outdoor use; aquatic nonfood industrial 
use; greenhouse nonfood crop use; forestry use; residential outdoor use; 
residential indoor use; indoor food use; indoor nonfood use; indoor 
medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides human health assessment. 
The test notes are shown in paragraph (e) of this section.

                                       Table--EUP Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 153]]

 
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 4
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   NR                  TGAI                TGAI                --
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                5
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                6
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vivo mammalian   R                   CR                  TGAI                TGAI                6, 7
                                   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                5
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides human 
health assessment as referenced in the last column of the table in 
paragraph (d) of this section.
    1. Required unless the test material is a gas or highly volatile 
(vapor pressure > 10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has pH 
<2 or >11.5.
    3. Required when the pesticide, under conditions of use, would 
result in respirable material (e.g., gas, volatile substance or aerosol/
particulate), unless it is a straight chain lepidopteran pheromone.
    4. Hypersensitivity incidents must be reported as adverse effects 
data.
    5. Required if the use of the product under widespread and commonly 
recognized practice may reasonably be expected to result in significant 
exposure to female humans (e.g., occupational exposure or repeated 
application of insect repellents directly to the skin). Tier II data is 
required on a different test species from Tier I data when developmental 
effects are observed in the first study and information on species-to-
species extrapolation is needed.
    6. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally 
related to a known mutagen or belongs to any chemical class of compounds 
containing a known mutagen.

    Additional mutagenicity tests that may have been performed plus a 
complete reference list must also be submitted. Subsequent testing may 
be required based on the available evidence.
    7. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene locus, 
maximizing

[[Page 154]]

assay conditions for small colony expression or detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung fibroblast 
(V79) cells, hypoxanthine-guanine phosphoribosyl transferase (hgprt) 
gene locus, accompanied by an appropriate in vivo test for 
clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl 
transferase (xprt) gene locus.



Sec. 158.2084  Experimental use permit biochemical pesticides nontarget
organisms and environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to 
use this table to determine the terrestrial and aquatic nontarget 
organisms and fate data requirements for a particular biochemical 
pesticide product. Notes that apply to an individual test including 
specific conditions, qualifications, or exceptions to the designated 
test are listed in paragraph (e) of this section. In general, for all 
outdoor end-use products including turf, the following studies are 
required: one avian acute oral, one avian dietary, one acute freshwater 
fish, and one acute freshwater invertebrate study.
    (2) The data in this section are not required for arthropod 
pheromones when applied at up to a maximum use rate of 150 grams active 
ingredient/acre/year except when the product is expected to be available 
to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products 
classified under the general use patterns of terrestrial food crop, 
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The 
greenhouse use pattern includes products classified under the general 
use patterns of greenhouse food crop and greenhouse nonfood crop. The 
indoor use pattern includes products classified under the general use 
patterns of indoor food and nonfood use. The remaining terrestrial uses 
include forestry and residential outdoor use. Data are also required for 
the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; Residue of 
concern=the active ingredient and its metabolites, degradates, and 
impurities of toxicological concern; All=All of the above. Specific 
conditions, qualifications, or exceptions to the designated test 
procedures appear in paragraph (e) of this section, and apply to the 
individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit biochemical pesticides nontarget organisms and 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                 Table--EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      2, 3, 4
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 155]]

 
850.1010                          Aquatic              R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........         2, 4
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit biochemical pesticides 
nontarget organisms and environmental fate as referenced in the last 
column of the table contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms or to support 
arthropod pheromones that would be available to avian wildlife, (e.g., a 
granular product).
    2. Not required for any use groups if the pesticide is highly 
volatile (estimated volatility >5 X 10-5atm m\3\/mol).
    3. Preferred test species are: upland game, waterfowl, or passerine 
for avian acute oral toxicity studies; upland game or waterfowl for 
avian dietary studies; and coldwater fish for acute freshwater fish 
studies.
    4. Required for the EP when the end-use formulation may contain 
other ingredients that may be toxic to nontarget organisms.



                     Subpart V_Microbial Pesticides

    Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.



Sec. 158.2100  Microbial pesticides definition and applicability.

    (a) This subpart applies to all living or dead microbial pesticides 
as described in paragraphs (b) and (c) of this section.
    (b) Definition. Microbial pesticide is a microbial agent intended 
for preventing, destroying, repelling, or mitigating any pest, or 
intended for use as a plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to, 
protozoa, algae, and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to, 
Eubacteria and Archaebacteria; or
    (3) Is a parasitically replicating microscopic element, including, 
but not limited to, viruses.
    (c) Applicability. (1) This part applies to microbial pesticides as 
specified in paragraphs (c)(2), (3) and (4) of this section.
    (2) Each new isolate of a microbial pesticide is treated as a new 
strain and must be registered independently of any similar registered 
microbial pesticide strain and supported by data required in this 
subpart.
    (3) Genetically modified microbial pesticides may be subject to 
additional data or information requirements on a case-by-case basis 
depending on the particular microbial agent and/or its parental strains, 
the proposed pesticide use pattern, and the manner and extent to which 
the organism has been genetically modified.
    (4) 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.



Sec. 158.2110  Microbial pesticides data requirements.

    (a) For all microbial pesticides. (1) The following Sec. 158.2120 
through Sec. 158.2150 identify the data requirements that are required 
to support registration of microbial pesticides. The variations in the 
test conditions are identified within the test notes.
    (2) Each data table includes ``use patterns'' under which the 
individual data are required, with variations including all use 
patterns, food and nonfood uses

[[Page 156]]

for terrestrial and aquatic applications, greenhouse, indoor, forestry, 
and residential outdoor applications under certain circumstances.
    (3) The categories for each data requirement are ``R,'' which stands 
for required, and ``CR'' which stands for conditionally required. If a 
bracket appears around the ``R'' or ``CR,'' the data are required for 
both the registration and experimental use permit requests. Generally, 
``R'' indicates that the data are more likely required than for those 
data requirements with ``CR.'' However, in each case, the regulatory 
text preceding the data table and the test notes following the data 
table must be used to determine whether the data requirement must be 
satisfied.
    (4) Each table identifies the test substance that is required to be 
tested to satisfy the data requirement. Test substances may include: 
technical grade active ingredient (TGAI), manufacturing-use product 
(MP), end-use product (EP), typical end-use product (TEP), residue of 
concern, and pure active ingredient (PAI) or all of the above (All). 
Commas between the test substances (i.e., TGAI, EP) indicate that data 
may be required on the TGAI or EP or both depending on the conditions 
set forth in the test note. Data requirements which list two test 
substances (i.e., TGAI and EP) indicate that both are required to be 
tested. Data requirements that list only MP as the test substance apply 
to products containing solely the technical grade of the active 
ingredient and manufacturing-use products to which other ingredients 
have been intentionally added. Data requirements listing the EP as the 
test substance apply to any EP with an ingredient in the end-use 
formulation other than the active ingredient that is expected to enhance 
the toxicity of the product.
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: 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 selected Tier II 
environmental expression and toxicology tests.



Sec. 158.2120  Microbial pesticides product analysis data requirements 
table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product analysis data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test are 
identified in paragraph (d) of this section, and the test notes appear 
in paragraph (e) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticides product analysis. The test notes are shown in 
paragraph (d) of this section.

                                             Table--Microbial Pesticides Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                     Test Substance
          Guideline Number               Data Requirement        All Use Patterns   ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                            Product Identity       R                        MP                    EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                            Manufacturing process  R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 157]]

 
                                      Deposition of a        R                       TGAI                   TGAI                   --
                                      sample in a
                                      nationally recognized
                                      culture collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1300                            Discussion of          R                       TGAI and MP            TGAI and EP            --
                                      formation of
                                      unintentional
                                      ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                            Analysis of samples    R                       TGAI and MP            TGAI and EP            1
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                            Certification of       R                       MP                     EP                     --
                                      limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                            Color                  R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6303                            Physical state         R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                            Odor                   R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                            Stability to normal    R                       TGAI                   TGAI                   --
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                            Storage stability      R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                            Miscibility            R                       MP                     EP                     2
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                            Corrosion              R                       MP                     EP                     3
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                            pH                     R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                            Viscosity              R                       MP                     EP                     4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                            Density/relative       R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides product analysis as referenced in 
the last column of the table contained in paragraph (c) of this section.
    1. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no potential 
for microbial contamination or microbial regrowth. For full 
registration, generally an analysis of samples is a compilation of 
batches, over a period of time, depending on the frequency of 
manufacturing.
    2. Only required for emulsifiable liquid forms of microbial 
pesticides.
    3. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    4. Only required for liquid forms of microbial pesticides.



Sec. 158.2130  Microbial pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test appear 
in paragraph (d) of this section, and the procedures appear in paragraph 
(e) of this section.
    (b) Key. R=required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:

[[Page 158]]

    (c) Table. The following table shows the data requirements for 
microbial pesticides residue. The test notes are shown in paragraph (d) 
of this section.

                              Table--Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test Substance
        Guideline Number            Data Requirement    All Use Patterns  Data to Support MP       Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                           Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                           Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                           Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                           Analytical          CR                  TGAI                1
                                   methods - plants
----------------------------------------------------------------------------------------------------------------
885.2350                           Analytical          CR                  TGAI                1
                                   methods - animals
----------------------------------------------------------------------------------------------------------------
885.2400                           Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                           Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                           Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                           Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data 
requirements for microbial pesticides residue as referenced in the last 
column of the table contained in paragraph (c) of this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects or 
the product characterization indicates the microbial pesticide has a 
significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or on 
food or feed crops.



Sec. 158.2140  Microbial pesticides toxicology data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular pesticide product. Notes that apply to an individual test and 
include specific conditions, qualifications, or exceptions to the 
designated test are listed in paragraph (d) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticides toxicology. The test notes are shown in paragraph 
(d) of this section.

                            Table--Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------
885.3050                           Acute oral         R                    TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                           Acute pulmonary    R                    TGAI               --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                           Acute injection    R                    TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                   Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                           Hypersensitivity   R                    All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                           Cell culture       R                    TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                           Acute oral         R                    MP , EP             1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                           Acute dermal       R                    MP , EP             5
                                   toxicity
----------------------------------------------------------------------------------------------------------------

[[Page 159]]

 
870.1300                           Acute inhalation   R                    MP , EP             5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                           Acute eye          R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                           Primary dermal     R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                           Acute toxicology    CR                  TGAI                7
----------------------------------------------------------------------------------------------------------------
885.3600                           Subchronic          CR                  TGAI                8
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                           Reproductive        CR                  TGAI                9, 13
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                           Carcinogenicity     CR                  TGAI                10, 13
----------------------------------------------------------------------------------------------------------------
870.7800                           Immunotoxicity      CR                  TGAI                11, 13
----------------------------------------------------------------------------------------------------------------
885.3000                           Infectivity/        CR                  TGAI                12, 13
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides toxicology as referenced in the 
last column of the table contained in paragraph (c) of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose portion 
of the acute oral toxicity study, with an EP or MP test material to 
fulfill the requirement for the TGAI and the MP or EP in a single study, 
if the new protocol is designed to address the endpoints of concern.
    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use of 
an intravenous injection, the intraperitoneal injection procedure may be 
employed.
    3. Hypersensitivity incidents, including immediate type and delayed-
type reactions of humans or domestic animals, occur during the testing 
or production of the TGAI, MP, or EP, or are otherwise known to the 
applicant must be reported if they occur.
    4. Data must be submitted only for products whose active ingredient 
is a virus.
    5. The 870 series studies for the MP and EP are intended to provide 
data on the acute toxicity of the product. Waivers for any or all of 
these studies may be granted when the applicant can demonstrate that the 
combination of inert ingredients is not likely to pose any significant 
human health risks. Where appropriate, the limit dose approach to 
testing is recommended.
    6. Required when the product consists of, or under conditions of use 
would result in, an inhalable material (e.g., gas, volatile substances, 
or aerosol particulate).
    7. Data required when significant toxicity, in the absence of 
pathogenicity and significant infectivity, is observed in acute oral, 
injection, or pulmonary studies (Tier I). Route(s) of exposure 
correspond to route(s) where toxicity was observed in Tier I studies. 
The toxic component of the TGAI is to be tested.
    8. Data required when significant infectivity and/or unusual 
persistence is observed in the absence of pathogenicity or toxicity in 
Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to 
routes in Tier I studies where adverse effects were noted. Data may also 
be required to evaluate adverse effects due to microbial contaminants or 
to toxic byproducts.
    9. Data are required when one or more of the following criteria are 
met:
    i. Significant infectivity of the microbial pest control agent 
(MPCA) was observed in test animals in the Tier II subchronic study and 
in which no significant signs of toxicity or pathogenicity were 
observed.
    ii. The microbial pesticide is a virus which can persist or 
replicate in mammalian cell culture lines.
    iii. The microbial pesticide is not amenable to thorough taxonomic 
classification, and is related to organisms known to be parasitic for 
mammalian cells.
    iv. The microbial pesticide preparation is not well purified, and 
may contain contaminants which are parasitic for mammals.
    10. Data may be required for products known to contain or suspected 
to contain carcinogenic viruses or for microbial components that are 
identified as having significant toxicity in Tier II testing.
    11. Data may be required for products known to contain or suspected 
to contain viruses that can interact in an adverse manner with 
components of the mammalian immune system.
    12. An analysis of human infectivity/pathogenicity potential using 
scientific literature, genomic analysis, and/or actual specific cell 
culture/animal data may be required for products known to contain or 
suspected of containing intracellular parasites of mammalian cells for 
products that exhibit pathogenic characteristics in Tier I and/or Tier 
II, for products which are closely related to known human pathogens 
based on the product analysis data, or for known human pathogens that 
have been ``disarmed'' or rendered non-pathogenic for humans.
    13. Test standards may have to be modified depending on the 
characteristics of the microorganism. Requirements may vary for

[[Page 160]]

these studies depending on the active ingredient being tested. 
Consultation with the Agency is advised before performing these Tier III 
studies.



Sec. 158.2150  Microbial pesticides nontarget organisms and 
environmental fate data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget organisms 
data requirements for a particular microbial pesticide product. Notes 
that apply to an individual test including specific conditions, 
qualifications, or exceptions to the designated test are listed in 
paragraph (e) of this section.
    (b) Use patterns. Aquatic uses include: food and feed, nonfood uses 
(e.g., outdoor, residential, and industrial). Terrestrial uses include: 
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food 
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
microbial pesticides nontarget organisms and environmental fate. The 
test notes are shown in paragraph (e) of this section.

                                                                        Table--Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                 Terrestrial
        Guideline Number         Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------   Test Substance      Test Notes
                                                                                                                                 Residential        Greenhouse          Indoor
                                                        Food/Feed           Nonfood          Food/Feed/          Forestry    ------------------------------------------------------     Industrial
                                                                                              Nonfood                              Outdoor         Food/Nonfood     Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                         Avian oral        R                   R                  R                  R                 R                 CR               CR                CR                TGAI              1, 2
                                 toxicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4100                        Avian inhalation    CR                CR                 CR                 CR                CR                CR                CR                CR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4150                        Wild mammal         CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 4
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish     R                  R                  R                  R                 CR               CR                CR                CR                TGAI or TEP       1, 2, 5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                   R                  R                  R                 CR               CR                CR                CR                TGAI or TEP       1, 2, 5
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4280                        Estuarine/Marine    CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              1, 6
                                 fish testing
                                Estuarine and
                                 marine
                                 invertebrate
                                 testing.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant     CR                CR                 CR                 R                  CR               NR                CR                CR                TEP                1, 7
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                   R                  R                  R                 R                 CR               NR                CR                TGAI              1, 8
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                   R                  R                 R                 CR               NR                CR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 161]]

 
885.5200                        Terrestrial         CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        9
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5300                        Freshwater          CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        10
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5400                        Marine or           CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        11, 12
                                 estuarine
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4600                        Avian chronic      CR                  CR                CR                 CR                CR                NR                NR                CR                TGAI              12, 13
                                 pathogenicity
                                 and reproduction
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4650                        Aquatic             CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 invertebrate
                                 range testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4700                        Fish life cycle     CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI              12, 14
                                 studies
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4750                        Aquatic ecosystem  CR                  CR                CR                 CR                CR                NR                NR                CR                TGAI              15
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier IV
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Field testing for   CR                CR                 CR                 CR                CR                NR                NR                CR                TGAI or TEP        11, 16
850.1950......................   terrestrial
                                 wildlife and
                                 Field testing
                                 for aquatic
                                 organisms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 17, 20
                                 actual field
                                 tests (birds,
                                 mammals)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 test (aquatic
                                 organisms)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 predators,
                                 parasites)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (insect
                                 pollinators)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                        Simulated or       CR                  CR                CR                 CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (plants)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 162]]

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian inhalation 
toxicity/pathogenicity study and the avian chronic toxicity/
pathogenicity study is the upland game. There is also the option to test 
the passerine if there is a concern. The coldwater fish is preferred for 
freshwater fish testing. However, two species (coldwater and warmwater 
fish species are the preferred species) must be tested for uses 
involving direct freshwater exposure. Freshwater invertebrate testing is 
also required.
    3. Data required when the nature of the microbial pesticide and/or 
its toxins indicates potential pathogenicity to birds.
    4. Required on a case-by-case basis if results of tests required by 
Sec. 158.2140 are inadequate or inappropriate for assessment of hazards 
to wild mammals.
    5. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    6. Required if the 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.
    7. Required if the microbial pesticide is taxonomically related to a 
known plant pathogen.
    8. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e., may 
create an epizootic condition in nontarget insects.
    9. Required if toxic or pathogenic effects are observed in one or 
more of the following tests for microbial pesticides:
    i. Avian acute oral or avian inhalation studies.
    ii. Wild mammal studies.
    iii. Nontarget plant studies (terrestrial).
    iv. Honey bee studies.
    v. Nontarget insect studies.
    10. Required when toxic or pathogenic effects are observed in any of 
the following Tier I tests for microbial pest control agents:
    i. Freshwater fish studies.
    ii. Freshwater invertebrate studies.
    iii. Nontarget plant studies (aquatic).
    11. Required if product is applied on land or in fresh water or 
marine/estuarine environments and toxic or pathogenic effects are 
observed in any of the following Tier I tests for microbial pesticides:
    i. Estuarine and marine animal toxicity and pathogenicity.
    ii. Plant studies - estuarine or marine species.
    12. An appropriate dose-response toxicity test is required when 
toxic effects on nontarget terrestrial wildlife or aquatic organisms 
(including plants) are reported in one or more Tier I tests and results 
of Tier II tests indicate exposure of the microbial agent to the 
affected nontarget terrestrial wildlife or aquatic organisms. The 
protocols for these tests may have to be modified in accordance with 
results from the nontarget organism and environmental expression 
studies.
    13. Required when one or more of the following are present:
    i. Pathogenic effects are observed in Tier I avian studies.
    ii. Tier II environmental expression testing indicate that long-term 
exposure of terrestrial animals is likely.
    14. 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 aquatic studies.
    15. Required if, after an analysis of the microbial pesticide's 
ability to survive and multiply in the environment and what ecological 
habitat it would occupy, the intended use patterns, and the results of 
previous nontarget organisms 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. Testing is to 
determine if applications of the microbial pest control would be 
expected to disrupt the balance of populations in the target ecosystem.
    16. Tier IV studies may be conducted as a condition of registration 
as post-registration monitoring if the potential for unreasonable 
adverse effects appears to be minimal during that period of use due to 
implementation of mitigation measures.
    17. Required when both of the following conditions occur:
    i. Pathogenic effects observed at actual or expected field residue 
exposure levels are reported in Tier III; and
    ii. The Agency determines that quarantine methods would not prevent 
the microbial pesticide from contaminating areas adjacent to the test 
area.
    18. 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.
    19. 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

[[Page 163]]

and growth of natural populations are observed) are required if 
laboratory data indicate that adverse long-term, cumulative, or life-
cycle effects may result from intended use.
    20. Since test standards would be developed on a case-by-case basis, 
consultation with the Agency and development of a protocol is advised 
before performing these Tier IV studies.



Sec. 158.2160  Microbial pesticides product performance data 
requirements.

    Product performance data must be developed for all microbial 
pesticides. However, the Agency has waived all requirements to submit 
efficacy data unless the pesticide product bears a claim to control 
public health pests, such as pest microorganisms infectious to man in 
any area of the inanimate environment or a claim to control vertebrates 
(including but not limited to: rodents, birds, bats, canids, and skunks) 
or invertebrates (including but not limited to: mosquitoes and ticks) 
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.



Sec. 158.2170  Experimental use permit data requirements--microbial
pesticides.

    (a) For all microbial pesticides. (1) The following Sec. 158.2171 
through Sec. 158.2174 identify the data requirements that are required 
to support experimental use permits for microbial pesticides. The 
variations in the test conditions are identified within the test notes.
    (2) For general information on the data requirement tables, see 
Sec. 158.2110(a)(2)-(4).
    (b) Additional data requirements for genetically modified microbial 
pesticides. Additional requirements for genetically modified microbial 
pesticides may include but are not limited to: 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 selected Tier II 
environmental expression and toxicology tests.



Sec. 158.2171  Experimental use permit microbial pesticides product 
analysis data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the product analysis data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test are 
identified in (d) of this section, and the test notes appear in 
paragraph (e) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
experimental use permit microbial pesticides product analysis. The test 
notes are shown in paragraph (d) of this section.

                                                 Table--EUP Microbial Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                               MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                           Product Identity        R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 164]]

 
  885.1200                           Manufacturing process   R                       TGAI and MP            TGAI and EP            1, 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                     Deposition of a sample  R                       TGAI                   TGAI                   --
                                      in a nationally
                                      recognized culture
                                      collection
                                    --------------------------------------------------------------------------------------------------------------------
  885.1300                           Discussion of           R                       TGAI and MP            TGAI and EP            2
                                      formation of
                                      unintentional
                                      ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                           Analysis of samples     R                       TGAI and MP            TGAI and EP            2, 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                           Certification of        R                       MP                     EP                     --
                                      limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                           Color                   R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6303                           Physical state          R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                           Odor                    R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                           Stability to normal     R                       TGAI                   TGAI                   --
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                           Storage stability       R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                           Miscibility             R                       MP                     EP                     4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                           Corrosion               R                       MP                     EP                     5
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                           pH                      R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                           Viscosity               R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                           Density/relative        R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit microbial pesticides product 
analysis as referenced in the last column of the table contained in 
paragraph (c) of this section.
    1. If an experimental use permit is being sought, and if the 
pesticide is not already under full-scale production, a schematic 
diagram and/or description of the manufacturing process suffices.
    2. If an experimental use permit is being sought, and if the product 
is not already under full-scale production, a discussion of 
unintentional ingredients is required to be submitted to the extent this 
information is available.
    3. Required to support registration of each manufacturing-use 
product and end-use product. This analysis must be conducted at the 
point in the production process after which there would be no potential 
for microbial contamination or microbial regrowth. For pesticides in the 
production stage, a preliminary product analytical method and data would 
suffice to support an experimental use permit. For full registration, 
generally an analysis of samples is a compilation of batches, over a 
period of time, depending on the frequency of manufacturing.
    4. Only required for emulsifiable liquid forms of microbial 
pesticides.
    5. Required when microbial pesticides are packaged in metal, 
plastic, or paper containers.
    6. Only required for liquid forms of microbial pesticides.



Sec. 158.2172  Experimental use permit microbial pesticides residue 
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the residue chemistry data requirements and the 
substance to be tested for a particular microbial pesticide. Specific 
conditions, qualifications, or exceptions to the designated test appear 
in (d) of this section, and

[[Page 165]]

the procedures appear in paragraph (e) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
experimental use permit microbial pesticides residue. The test notes are 
shown in paragraph (d) of this section.

                            Table--EUP Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                            Test Substance
        Guideline Number           Data Requirement    All Use Patterns   Data to Support MP      Test Notes
                                                                                 or EP
----------------------------------------------------------------------------------------------------------------
885.2100                          Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                          Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                          Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                          Analytical methods  CR                  TGAI                1
                                   - plants
----------------------------------------------------------------------------------------------------------------
885.2350                          Analytical methods- CR                  TGAI                1
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2400                          Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                          Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                          Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                          Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data 
requirements for experimental use permit microbial pesticides residue as 
referenced in the last column of the table contained in paragraph (c) of 
this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects or 
the product characterization indicates the microbial pesticide has a 
significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or on 
food or feed crops.



Sec. 158.2173  Experimental use permit microbial pesticides toxicology 
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the toxicology data requirements for a 
particular microbial pesticide product. Notes that apply to an 
individual test and include specific conditions, qualifications, or 
exceptions to the designated test are listed in paragraph (d) of this 
section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (d) of this section, and 
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for 
microbial pesticide toxicology. The test notes are shown in paragraph 
(d) of this section.

                          Table--EUP Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
885.3050                          Acute oral          R                   TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                          Acute pulmonary     R                   TGAI                --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                          Acute injection     R                   TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                  Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                          Hypersensitivity    R                   All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                          Cell culture        R                   TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   MP, EP              1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   MP, EP              5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   MP, EP              5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------

[[Page 166]]

 
870.2400                          Acute eye           R                   MP, EP              5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      CR                  MP, EP              5
                                   irritation
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data 
requirements for experimental use permit microbial pesticides toxicology 
as referenced in the last column of the table contained in paragraph (c) 
of this section:
    1. The acute oral toxicity/pathogenicity study is required to 
support the TGAI. However, it can be combined with the unit dose portion 
of the acute oral toxicity study, with an EP or MP test material to 
fulfill the requirement for the TGAI and the MP or EP in a single study, 
if the new protocol is designed to address the endpoints of concern.
    2. Data not required for products whose active ingredient is a 
virus. For test materials whose size or consistency may prevent use of 
an intravenous injection, the intraperitoneal injection procedure may be 
employed.
    3. Hypersensitivity incidents, including immediate type and delayed 
type reactions of humans or domestic animals occur during the testing or 
production of the TGAI, MP, or EP, or are otherwise known to the 
applicant must be reported if they occur.
    4. Data must be submitted only for products whose active ingredient 
is a virus.
    5. The 870 series studies for the MP and EP are intended to provide 
data on the acute toxicity of the product. Waivers for any or all of 
these studies may be granted when the applicant can demonstrate that the 
combination of inert ingredients is not likely to pose any significant 
human health risks. Where appropriate, the limit dose approach to 
testing is recommended.
    6. Required when the product consists of, or under conditions of use 
that would result in an inhalable material (e.g., gas, volatile 
substances, or aerosol particulate).



Sec. 158.2174  Experimental use permit microbial pesticides nontarget
organisms and environmental fate data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use 
this table to determine the terrestrial and aquatic nontarget organisms 
data requirements for a particular microbial pesticide product. Notes 
that apply to an individual test including specific conditions, 
qualifications, or exceptions to the designated test are listed in 
paragraph (e) of this section.
    (b) Use patterns. Aquatic uses include: food and feed, nonfood uses 
(e.g., outdoor, residential, and industrial). Terrestrial uses include: 
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food 
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required; 
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use 
product; TGAI=Technical grade of the active ingredient; All=All of the 
above. Specific conditions, qualifications, or exceptions to the 
designated test procedures appear in paragraph (e) of this section, and 
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for 
experimental use permit microbial pesticides nontarget organisms and 
environmental fate. The test notes are shown in paragraph (e) of this 
section.

                                                                      Table--EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                      Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                Terrestrial
       Guideline Number          Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------  Test Substance      Test Notes
                                                                                                                                 Residential       Greenhouse          Indoor
                                                       Food/Feed           Nonfood       Food/Feed/Nonfood      Forestry     ------------------------------------------------------    Industrial
                                                                                                                                   Outdoor        Food/Nonfood      Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                        Avian oral         NR                 R                  R                  R                 R                 NR                NR                NR                TGAI              1, 2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 167]]

 
885.4200                        Freshwater fish    NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant    NR                 NR                 NR                 R                 NR                NR                NR                NR                TEP               1, 4
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1, 5
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data 
requirements for microbial pesticides nontarget organism and 
environmental fate as referenced in the last column of the table 
contained in paragraph (d) of this section.
    1. Tests for pesticides intended solely for indoor application would 
be required on a case-by-case basis, depending on use pattern, 
production volume, and other pertinent factors. Tests to support EUP's 
are based on the application timing and acreage.
    2. The preferred species for the avian oral study is either the 
upland game or waterfowl. The preferred species for the avian inhalation 
toxicity/pathogenicity study and the avian chronic toxicity/
pathogenicity study is the upland game. There is also the option to test 
a passerine species if there is a concern. The coldwater fish is 
preferred for freshwater fish testing. However, two species (coldwater 
and warmwater fish are the preferred species) must be tested for uses 
involving direct freshwater exposure. Freshwater invertebrates are 
preferred for invertebrate testing.
    3. Required when there will be significant exposure to aquatic 
organisms (fish and invertebrates).
    4. Required if the microbial pesticide is taxonomically related to a 
known plant pathogen.
    5. Data are not required unless an active microbial ingredient 
controls the target insect pest by a mechanism of infectivity; i.e., may 
create an epizootic condition in nontarget insects.



              Subpart W_Antimicrobial Pesticides [Reserved]



Sec. 158.2200  [Reserved]



                         Subparts X	Z [Reserved]



Sec. Sec. 158.2300-158.2500  [Reserved]



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.

[[Page 168]]

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 subpart:
    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.
    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,

[[Page 169]]

and submerged plants), and terrestrial (all non-aquatic) plants.
    Water reference level 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; 
73 FR 75596, Dec. 12, 2008]



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]



Sec. 159.156  How information must be submitted.

    A submission under FIFRA section 6(a)(2) must be delivered to the 
Office of Pesticide Programs' Document Processing Desk at the 
appropriate address as set forth in 40 CFR 150.17(a) or (b).
    (a) 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).
    (b) 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.
    (c) 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).
    (d) In reporting incidents, provide the data listed in Sec. 
159.184, to the extent such information is available.
    (e) In submitting scientific studies, follow the procedures set 
forth in Sec. 158.32 or Sec. 161.32 of this chapter, as applicable.

[[Page 170]]

    (f) 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.
    (g) 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 or 
Sec. 161.33 of this chapter, as applicable regarding the identification 
and segregation of information claimed to be confidential.
    (h) If a submission includes a study subject to the flagging 
requirements of Sec. 158.34 or Sec. 161.34 of this chapter, as 
applicable, comply with the requirements of that section, and, if the 
flagging statement is positive, identify it as 6(a)(2) information in 
the transmittal.
    (i) 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; 
71 FR 35545, June 21, 2006; 72 FR 61028, Oct. 26, 2007]



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 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.

[[Page 171]]

    (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, 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.

[[Page 172]]

    (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.
    (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 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, as amended at 
73 FR 75596, Dec. 12, 2008]



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 
156.62.
    (b) Ecological studies. The results of a study of the toxicity of a 
pesticide to

[[Page 173]]

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 regimen 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 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 regimen lasting more 
than 90 calendar days, 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; 73 FR 75597, 
Dec. 12, 2008]



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

[[Page 174]]

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 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.

[[Page 175]]

    (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:
    (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.

[[Page 176]]

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.
    (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

[[Page 177]]

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.
    (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.

[[Page 178]]

    (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.
    (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

[[Page 179]]

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 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:

[[Page 180]]

    (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 tha may pose a risk to human 
health, including any of the public health antimicrobials identified in 
part 161 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.
    (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.

[63 FR 49388, Sept. 19, 1997, as amended at 72 FR 61029, Oct. 26, 2007]



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.

[[Page 181]]

    (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 and applicability.
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.
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, 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 and applicability.

    (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, as amended, and section 408 
or 409 of the Federal Food, Drug and Cosmetic Act.
    (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.

[73 FR 75597, Dec. 12, 2008]

[[Page 182]]



Sec. 160.3  Definitions.

    As used in this part the following terms shall have the meanings 
specified:
    Application for research or marketing permit means any of the 
following:
    (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 that was submitted prior to August 3, 1996.
    (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).
    Person means an individual, partnership, corporation, association, 
scientific or academic establishment, government agency or 
organizational unit thereof, or 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.
    Specimen 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;

[[Page 183]]

    (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 of 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 158.400 or 161.640, as applicable), 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.

[54 FR 34067, Aug. 17, 1989, as amended at 72 FR 61029, Oct. 26, 2007; 
73 FR 75597, Dec. 12, 2008]



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

[[Page 184]]

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 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.

[[Page 185]]

    (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 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

[[Page 186]]

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.



Sec. 160.43  Test system care facilities.

    (a) A testing facility shall have a sufficient number of animal 
rooms or other test system areas, as needed, to ensure: proper 
separation of species or test systems, isolation of individual projects, 
quarantine or isolation of animals or other test systems, and routine or 
specialized housing of animals or other test systems.
    (1) In tests with plants or aquatic animals, proper separation of 
species can be accomplished within a room or area by housing them 
separately in different chambers or aquaria. Separation of species is 
unnecessary where the protocol specifies the simultaneous exposure of 
two or more species in the same chamber, aquarium, or housing unit.
    (2) Aquatic toxicity tests for individual projects shall be isolated 
to the extent necessary to prevent cross-contamination of different 
chemicals used in different tests.
    (b) A testing facility shall have a number of animal rooms or other 
test system areas separate from those described in paragraph (a) of this 
section to ensure isolation of studies being done with test systems or 
test, control, and reference substances known to be biohazardous, 
including volatile substances, aerosols, radioactive materials, and 
infectious agents.
    (c) Separate areas shall be provided, as appropriate, for the 
diagnosis, treatment, and control of laboratory test system diseases. 
These areas shall provide effective isolation for the housing of test 
systems either known or suspected of being diseased, or of being 
carriers of disease, from other test systems.
    (d) Facilities shall have proper provisions for collection and 
disposal of contaminated water, soil, or other spent materials. When 
animals are housed, facilities shall exist for the collection and 
disposal of all animal waste and refuse or for safe sanitary storage of 
waste before removal from the testing facility. Disposal facilities 
shall be so provided and operated as to minimize vermin infestation, 
odors, disease hazards, and environmental contamination.
    (e) Facilities shall have provisions to regulate environmental 
conditions (e.g., temperature, humidity, photoperiod) as specified in 
the protocol.
    (f) For marine test organisms, an adequate supply of clean sea water 
or artificial sea water (prepared from deionized or distilled water and 
sea salt mixture) shall be available. The ranges of composition shall be 
as specified in the protocol.
    (g) For freshwater organisms, an adequate supply of clean water of 
the appropriate hardness, pH, and temperature, and which is free of 
contaminants capable of interfering with the study, shall be available 
as specified in the protocol.
    (h) For plants, an adequate supply of soil of the appropriate 
composition, as specified in the protocol, shall be available as needed.



Sec. 160.45  Test system supply facilities.

    (a) There shall be storage areas, as needed, for feed, nutrients, 
soils, bedding, supplies, and equipment. Storage areas for feed 
nutrients, soils, and bedding shall be separated from areas where the 
test systems are located and shall be protected against infestation or 
contamination. Perishable supplies

[[Page 187]]

shall be preserved by appropriate means.
    (b) When appropriate, plant supply facilities shall be provided. As 
specified in the protocol, these include:
    (1) Facilities for holding, culturing, and maintaining algae and 
aquatic plants.
    (2) Facilities for plant growth, including, but not limited to 
greenhouses, growth chambers, light banks, and fields.
    (c) When appropriate, facilities for aquatic animal tests shall be 
provided. These include, but are not limited to, aquaria, holding tanks, 
ponds, and ancillary equipment, as specified in the protocol.



Sec. 160.47  Facilities for handling test, control, and reference 
substances.

    (a) As necessary to prevent contamination or mixups, there shall be 
separate areas for:
    (1) Receipt and storage of the test, control, and reference 
substances.
    (2) Mixing of the test, control, and reference substances with a 
carrier, e.g., feed.
    (3) Storage of the test, control, and reference substance mixtures.
    (b) Storage areas for test, control, and/or reference substance and 
for test, control, and/or reference mixtures shall be separate from 
areas housing the test systems and shall be adequate to preserve the 
identity, strength, purity, and stability of the substances and 
mixtures.



Sec. 160.49  Laboratory operation areas.

    Separate laboratory space and other space shall be provided, as 
needed, for the performance of the routine and specialized procedures 
required by studies.



Sec. 160.51  Specimen and data storage facilities.

    Space shall be provided for archives, limited to access by 
authorized personnel only, for the storage and retrieval of all raw data 
and specimens from completed studies.



                           Subpart D_Equipment



Sec. 160.61  Equipment design.

    Equipment used in the generation, measurement, or assessment of data 
and equipment used for facility environmental control shall be of 
appropriate design and adequate capacity to function according to the 
protocol and shall be suitably located for operation, inspection, 
cleaning, and maintenance.



Sec. 160.63  Maintenance and calibration of equipment.

    (a) Equipment shall be adequately inspected, cleaned, and 
maintained. Equipment used for the generation, measurement, or 
assessment of data shall be adequately tested, calibrated, and/or 
standardized.
    (b) The written standard operating procedures required under Sec. 
160.81(b)(11) shall set forth in sufficient detail the methods, 
materials, and schedules to be used in the routine inspection, cleaning, 
maintenance, testing, calibration, and/ or standardization of equipment, 
and shall specify, when appropriate, remedial action to be taken in the 
event of failure or malfunction of equipment. The written standard 
operating procedures shall designate the person responsible for the 
performance of each operation.
    (c) Written records shall be maintained of all inspection, 
maintenance, testing, calibrating, and/or standardizing operations. 
These records, containing the dates of the operations, shall describe 
whether the maintenance operations were routine and followed the written 
standard operating procedures. Written records shall be kept of 
nonroutine repairs performed on equipment as a result of failure and 
malfunction. Such records shall document the nature of the defect, how 
and when the defect was discovered, and any remedial action taken in 
response to the defect.



                 Subpart E_Testing Facilities Operation



Sec. 160.81  Standard operating procedures.

    (a) A testing facility shall have standard operating procedures in 
writing setting forth study methods that management is satisfied are 
adequate to insure the quality and integrity of the data generated in 
the course of a study. All deviations in a study from standard operating 
procedures shall be

[[Page 188]]

authorized by the study director and shall be documented in the raw 
data. Significant changes in established standard operating procedures 
shall be properly authorized in writing by management.
    (b) Standard operating procedures shall be established for, but not 
limited to, the following:
    (1) Test system area preparation.
    (2) Test system care.
    (3) Receipt, identification, storage, handling, mixing, and method 
of sampling of the test, control, and reference substances.
    (4) Test system observations.
    (5) Laboratory or other tests.
    (6) Handling of test systems found moribund or dead during study.
    (7) Necropsy of test systems or postmortem examination of test 
systems.
    (8) Collection and identification of specimens.
    (9) Histopathology.
    (10) Data handling, storage and retrieval.
    (11) Maintenance and calibration of equipment.
    (12) Transfer, proper placement, and identification of test systems.
    (c) Each laboratory or other study area shall have immediately 
available manuals and standard operating procedures relative to the 
laboratory or field procedures being performed. Published literature may 
be used as a supplement to standard operating procedures.
    (d) A historical file of standard operating procedures, and all 
revisions thereof, including the dates of such revisions, shall be 
maintained.



Sec. 160.83  Reagents and solutions.

    All reagents and solutions in the laboratory areas shall be labeled 
to indicate identity, titer or concentration, storage requirements, and 
expiration date. Deteriorated or outdated reagents and solutions shall 
not be used.



Sec. 160.90  Animal and other test system care.

    (a) There shall be standard operating procedures for the housing, 
feeding, handling, and care of animals and other test systems.
    (b) All newly received test systems from outside sources shall be 
isolated and their health status or appropriateness for the study shall 
be evaluated. This evaluation shall be in accordance with acceptable 
veterinary medical practice or scientific methods.
    (c) At the initiation of a study, test systems shall be free of any 
disease or condition that might interfere with the purpose or conduct of 
the study. If during the course of the study, the test systems contract 
such a disease or condition, the diseased test systems should be 
isolated, if necessary. These test systems may be treated for disease or 
signs of disease provided that such treatment does not interfere with 
the study. The diagnosis, authorization of treatment, description of 
treatment, and each date of treatment shall be documented and shall be 
retained.
    (d) Warm-blooded animals, adult reptiles, and adult terrestrial 
amphibians used in laboratory procedures that require manipulations and 
observations over an extended period of time or in studies that require 
these test systems to be removed from and returned to their test system-
housing units for any reason (e.g., cage cleaning, treatment, etc.), 
shall receive appropriate identification (e.g., tattoo, color code, ear 
tag, ear punch, etc.). All information needed to specifically identify 
each test system within the test system-housing unit shall appear on the 
outside of that unit. Suckling mammals and juvenile birds are excluded 
from the requirement of individual identification unless otherwise 
specified in the protocol.
    (e) Except as specified in paragraph (e)(1) of this section, test 
systems of different species shall be housed in separate rooms when 
necessary. Test systems of the same species, but used in different 
studies, should not ordinarily be housed in the same room when 
inadvertent exposure to test, control, or reference substances or test 
system mixup could affect the outcome of either study. If such mixed 
housing is necessary, adequate differentiation by space and 
identification shall be made.
    (1) Plants, invertebrate animals, aquatic vertebrate animals, and 
organisms that may be used in multispecies tests need not be housed in 
separate rooms, provided that they are adequately segregated to avoid 
mixup and cross contamination.

[[Page 189]]

    (2) [Reserved]
    (f) Cages, racks, pens, enclosures, aquaria, holding tanks, ponds, 
growth chambers, and other holding, rearing and breeding areas, and 
accessory equipment, shall be cleaned and sanitized at appropriate 
intervals.
    (g) Feed, soil, and water used for the test systems shall be 
analyzed periodically to ensure that contaminants known to be capable of 
interfering with the study and reasonably expected to be present in such 
feed, soil, or water are not present at levels above those specified in 
the protocol. Documentation of such analyses shall be maintained as raw 
data.
    (h) Bedding used in animal cages or pens shall not interfere with 
the purpose or conduct of the study and shall be changed as often as 
necessary to keep the animals dry and clean.
    (i) If any pest control materials are used, the use shall be 
documented. Cleaning and pest control materials that interfere with the 
study shall not be used.
    (j) All plant and animal test systems shall be acclimatized to the 
environmental conditions of the test, prior to their use in a study.



            Subpart F_Test, Control, and Reference Substances



Sec. 160.105  Test, control, and reference substance characterization.

    (a) The identity, strength, purity, and composition, or other 
characteristics which will appropriately define the test, control, or 
reference substance shal1 be determined for each batch and shall be 
documented before its use in a study. Methods of synthesis, fabrication, 
or derivation of the test, control, or reference substance shall be 
documented by the sponsor or the testing facility, and the location of 
such documentation shall be specified.
    (b) When relevant to the conduct of the study the solubility of each 
test, control, or reference substance shall be determined by the testing 
facility or the sponsor before the experimental start date. The 
stability of the test, control, or reference substance shall be 
determined before the experimental start date or concomitantly according 
to written standard operating procedures, which provide for periodic 
analysis of each batch.
    (c) Each storage container for a test, control, or reference 
substance shall be labeled by name, chemical abstracts service number 
(CAS) or code number, batch number, expiration date, if any, and, where 
appropriate, storage conditions necessary to maintain the identity, 
strength, purity, and composition of the test, control, or reference 
substance. Storage containers shall be assigned to a particular test 
substance for the duration of the study.
    (d) For studies of more than 4 weeks experimental duration, reserve 
samples from each batch of test, control, and reference substances shall 
be retained for the period of time provided by Sec. 160.195.
    (e) The stability of test, control, and reference substances under 
storage conditions at the test site shall be known for all studies.



Sec. 160.107  Test, control, and reference substance handling.

    Procedures shall be established for a system for the handling of the 
test, control, and reference substances to ensure that:
    (a) There is proper storage.
    (b) Distribution is made in a manner designed to preclude the 
possibility of contamination, deterioration, or damage.
    (c) Proper identification is maintained throughout the distribution 
process.
    (d) The receipt and distribution of each batch is documented. Such 
documentation shall include the date and quantity of each batch 
distributed or returned.



Sec. 160.113  Mixtures of substances with carriers.

    (a) For each test, control, or reference substance that is mixed 
with a carrier, tests by appropriate analytical methods shall be 
conducted:
    (1) To determine the uniformity of the mixture and to determine, 
periodically, the concentration of the test, control, or reference 
substance in the mixture.
    (2) When relevant to the conduct of the study, to determine the 
solubility

[[Page 190]]

of each test, control, or reference substance in the mixture by the 
testing facility or the sponsor before the experimental start date.
    (3) To determine the stability of the test, control, or reference 
substance in the mixture before the experimental start date or 
concomitantly according to written standard operating procedures, which 
provide for periodic analysis of each batch.
    (b) Where any of the components of the test, control, or reference 
substance carrier mixture has an expiration date, that date shall be 
clearly shown on the container. If more than one component has an 
expiration date, the earliest date shall be shown.
    (c) If a vehicle is used to facilitate the mixing of a test 
substance with a carrier, assurance shall be provided that the vehicle 
does not interfere with the integrity of the test.



              Subpart G_Protocol for and Conduct of a Study



Sec. 160.120  Protocol.

    (a) Each study shall have an approved written protocol that clearly 
indicates the objectives and all methods for the conduct of the study. 
The protocol shall contain but shall not necessarily be limited to the 
following information:
    (1) A descriptive title and statement of the purpose of the study.
    (2) Identification of the test, control, and reference substance by 
name, chemical abstracts service (CAS) number or code number.
    (3) The name and address of the sponsor and the name and address of 
the testing facility at which the study is being conducted.
    (4) The proposed experimental start and termination dates.
    (5) Justification for selection of the test system.
    (6) Where applicable, the number, body weight range, sex, source of 
supply, species, strain, substrain, and age of the test system.
    (7) The procedure for identification of the test system.
    (8) A description of the experimental design, including methods for 
the control of bias.
    (9) Where applicable, a description and/or identification of the 
diet used in the study as well as solvents, emulsifiers and/or other 
materials used to solubilize or suspend the test, control, or reference 
substances before mixing with the carrier. The description shall include 
specifications for acceptable levels of contaminants that are reasonably 
expected to be present in the dietary materials and are known to be 
capable of interfering with the purpose or conduct of the study if 
present at levels greater than established by the specifications.
    (10) The route of administration and the reason for its choice.
    (11) Each dosage level, expressed in milligrams per kilogram of body 
or test system weight or other appropriate units, of the test, control, 
or reference substance to be administered and the method and frequency 
of administration.
    (12) The type and frequency of tests, analyses, and measurements to 
be made.
    (13) The records to be maintained.
    (14) The date of approval of the protocol by the sponsor and the 
dated signature of the study director.
    (15) A statement of the proposed statistical method to be used.
    (b) All changes in or revisions of an approved protocol and the 
reasons therefore shall be documented, signed by the study director, 
dated, and maintained with the protocol.



Sec. 160.130  Conduct of a study.

    (a) The study shall be conducted in accordance with the protocol.
    (b) The test systems shall be monitored in conformity with the 
protocol.
    (c) Specimens shall be identified by test system, study, nature, and 
date of collection. This information shall be located on the specimen 
container or shall accompany the specimen in a manner that precludes 
error in the recording and storage of data.
    (d) In animal studies where histopathology is required, records of 
gross findings for a specimen from postmortem observations shall be 
available to a pathologist when examining that specimen 
histopathologically.

[[Page 191]]

    (e) All data generated during the conduct of a study, except those 
that are generated by automated data collection systems, shall be 
recorded directly, promptly, and legibly in ink. All data entries shall 
be dated on the day of entry and signed or initialed by the person 
entering the data. Any change in entries shall be made so as not to 
obscure the original entry, shall indicate the reason for such change, 
and shall be dated and signed or identified at the time of the change. 
In automated data collection systems, the individual responsible for 
direct data input shall be identified at the time of data input. Any 
change in automated data entries shall be made so as not to obscure the 
original entry, shall indicate the reason for change, shall be dated, 
and the responsible individual shall be identified.



Sec. 160.135  Physical and chemical characterization studies.

    (a) All provisions of the GLP standards shall apply to physical and 
chemical characterization studies designed to determine stability, 
solubility, octanol water partition coefficient, volatility, and 
persistence (such as biodegradation, photodegradation, and chemical 
degradation studies) of test, control, or reference substances.
    (b) The following GLP standards shall not apply to studies, other 
than those designated in paragraph (a) of this section, designed to 
determine physical and chemical characteristics of a test, control, or 
reference substance:

Sec. 160.31 (c), (d), and (g)
Sec. 160.35 (b) and (c)
Sec. 160.43
Sec. 160.45
Sec. 160.47
Sec. 160.49
Sec. 160.81(b) (1), (2), (6) through (9), and (12)
Sec. 160.90
Sec. 160.105 (a) through (d)
Sec. 160.113
Sec. 160.120(a) (5) through (12), and (15)
Sec. 160.185(a) (5) through (8), (10), (12), and (14)
Sec. 160.195 (c) and (d)

Subparts H-I [Reserved]



                      Subpart J_Records and Reports



Sec. 160.185  Reporting of study results.

    (a) A final report shall be prepared for each study and shall 
include, but not necessarily be limited to, the following:
    (1) Name and address of the facility performing the study and the 
dates on which the study was initiated and was completed, terminated, or 
discontinued.
    (2) Objectives and procedures stated in the approved protocol, 
including any changes in the original protocol.
    (3) Statistical methods employed for analyzing the data.
    (4) The test, control, and reference substances identified by name, 
chemical abstracts service (CAS) number or code number, strength, 
purity, and composition, or other appropriate characteristics.
    (5) Stability and, when relevant to the conduct of the study the 
solubility of the test, control, and reference substances under the 
conditions of administration.
    (6) A description of the methods used.
    (7) A description of the test system used. Where applicable, the 
final report shall include the number of animals used, sex, body weight 
range, source of supply, species, strain and substrain, age, and 
procedure used for identification.
    (8) A description of the dosage, dosage regimen, route of 
administration, and duration.
    (9) A description of all circumstances that may have affected the 
quality or integrity of the data.
    (10) The name of the study director, the names of other scientists 
or professionals and the names of all supervisory personnel, involved in 
the study.
    (11) A description of the transformations, calculations, or 
operations performed on the data, a summary and analysis of the data, 
and a statement of the conclusions drawn from the analysis.
    (12) The signed and dated reports of each of the individual 
scientists or other professionals involved in the study, including each 
person who, at the request or direction of the testing facility or 
sponsor, conducted an analysis or evaluation of data or specimens

[[Page 192]]

from the study after data generation was completed.
    (13) The locations where all specimens, raw data, and the final 
report are to be stored.
    (14) The statement prepared and signed by the quality assurance unit 
as described in Sec. 160.35(b)(7).
    (b) The final report shall be signed and dated by the study 
director.
    (c) Corrections or additions to a final report shall be in the form 
of an amendment by the study director. The amendment shall clearly 
identify that part of the final report that is being added to or 
corrected and the reasons for the correction or addition, and shall be 
signed and dated by the person responsible. Modification of a final 
report to comply with the submission requirements of EPA does not 
constitute a correction, addition, or amendment to a final report.
    (d) A copy of the final report and of any amendment to it shall be 
maintained by the sponsor and the test facility.



Sec. 160.190  Storage and retrieval of records and data.

    (a) All raw data, documentation, records, protocols, specimens, and 
final reports generated as a result of a study shall be retained. 
Specimens obtained from mutagenicity tests, specimens of soil, water, 
and plants, and wet specimens of blood, urine, feces, and biological 
fluids, do not need to be retained after quality assurance verification. 
Correspondence and other documents relating to interpretation and 
evaluation of data, other than those documents contained in the final 
report, also shall be retained.
    (b) There shall be archives for orderly storage and expedient 
retrieval of all raw data, documentation, protocols, specimens, and 
interim and final reports. Conditions of storage shall minimize 
deterioration of the documents or specimens in accordance with the 
requirements for the time period of their retention and the nature of 
the documents of specimens. A testing facility may contract with 
commercial archives to provide a repository for all material to be 
retained. Raw data and specimens may be retained elsewhere provided that 
the archives have specific reference to those other locations.
    (c) An individual shall be identified as responsible for the 
archives.
    (d) Only authorized personnel shall enter the archives.
    (e) Material retained or referred to in the archives shall be 
indexed to permit expedient retrieval.



Sec. 160.195  Retention of records.

    (a) Record retention requirements set forth in this section do not 
supersede the record retention requirements of any other regulations in 
this subchapter.
    (b) Except as provided in paragraph (c) of this section, 
documentation records, raw data, and specimens pertaining to a study and 
required to be retained by this part shall be retained in the archive(s) 
for whichever of the following periods is longest:
    (1) In the case of any study used to support an application for a 
research or marketing permit approved by EPA, the period during which 
the sponsor holds any research or marketing permit to which the study is 
pertinent.
    (2) A period of at least 5 years following the date on which the 
results of the study are submitted to the EPA in support of an 
application for a research or marketing permit.
    (3) In other situations (e.g., where the study does not result in 
the submission of the study in support of an application for a research 
or marketing permit), a period of at least 2 years following the date on 
which the study is completed, terminated, or discontinued.
    (c) Wet specimens, samples of test, control, or reference 
substances, and specially prepared material which are relatively fragile 
and differ markedly in stability and quality during storage, shall be 
retained only as long as the quality of the preparation affords 
evaluation. Specimens obtained from mutagenicity tests, specimens of 
soil, water, and plants, and wet specimens of blood, urine, feces, and 
biological fluids, do not need to be retained after quality assurance 
verification. In no case shall retention be required for longer periods 
than those set forth in paragraph (b) of this section.

[[Page 193]]

    (d) The master schedule sheet, copies of protocols, and records of 
quality assurance inspections, as required by Sec. 160.35(c) shall be 
maintained by the quality assurance unit as an easily accessible system 
of records for the period of time specified in paragraph (b) of this 
section.
    (e) Summaries of training and experience and job descriptions 
required to be maintained by Sec. 160.29(b) may be retained along with 
all other testing facility employment records for the length of time 
specified in paragraph (b) of this section.
    (f) Records and reports of the maintenance and calibration and 
inspection of equipment, as required by Sec. 160.63 (b) and (c), shall 
be retained for the length of time specified in paragraph (b) of this 
section.
    (g) If a facility conducting testing or an archive contracting 
facility goes out of business, all raw data, documentation, and other 
material specified in this section shall be transferred to the archives 
of the sponsor of the study. The EPA shall be notified in writing of 
such a transfer.
    (h) Specimens, samples, or other non-documentary materials need not 
be retained after EPA has notified in writing the sponsor or testing 
facility holding the materials that retention is no longer required by 
EPA. Such notification normally will be furnished upon request after EPA 
or FDA has completed an audit of the particular study to which the 
materials relate and EPA has concluded that the study was conducted in 
accordance with this part.
    (i) Records required by this part may be retained either as original 
records or as true copies such as photocopies, microfilm, microfiche, or 
other accurate reproductions of the original records.



PART 161_DATA REQUIREMENTS FOR REGISTRATION OF ANTIMICROBIAL 
PESTICIDES--Table of Contents




                      Subpart A_General Provisions

Sec.
161.20 Overview.
161.25 Applicability of data requirements.
161.30 Timing of the imposition of data requirements.
161.32 Format of data submission.
161.33 Procedures for claims of confidentiality of data.
161.34 Flagging of studies for potential adverse effects.
161.35 Flexibility of the data requirements.
161.40 Consultation with the Agency.
161.45 Waivers.
161.55 Agricultural vs. non-agricultural pesticides.
161.60 Minor uses.
161.70 Acceptable protocols.
161.75 Requirements for additional data.
161.80 Acceptability of data.
161.85 Revision of data requirements and guidelines.

                    Subpart B_How To Use Data Tables

161.100 How to determine registration data requirements.
161.101 Required vs. conditionally required data.
161.102 Distinguishing between what data are required and what substance 
          is to be tested.
161.108 Relationship of Pesticide Assessment Guidelines to data 
          requirements.

              Subpart C_Product Chemistry Data Requirements

161.150 General.
161.153 Definitions.
161.155 Product composition.
161.160 Description of materials used to produce the product.
161.162 Description of production process.
161.165 Description of formulation process.
161.167 Discussion of formation of impurities.
161.170 Preliminary analysis.
161.175 Certified limits.
161.180 Enforcement analytical method.
161.190 Physical and chemical characteristics.

                    Subpart D_Data Requirement Tables

161.202 Purposes of the registration data requirements.
161.240 Residue chemistry data requirements.
161.290 Environmental fate data requirements.
161.340 Toxicology data requirements.
161.390 Reentry protection data requirements.
161.440 Spray drift data requirements.
161.490 Wildlife and aquatic organisms data requirements.
161.540 Plant protection data requirements.
161.590 Nontarget insect data requirements.
161.640 Product performance data requirements.

Appendix A to Part 161--Data Requirements for Registration: Use Pattern 
          Index.


[[Page 194]]


    Authority: 7 U.S.C. 136-136y.

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated at 72 FR 60253, Oct. 24, 2007.



                      Subpart A_General Provisions

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253, 60254, Oct. 24, 2007.



Sec. 161.20  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 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. 161.25  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. 161.100 and 161.101.
    (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. 161.35 
Flexibility of the data requirements, Sec. 161.40 Consultation with the 
Agency, Sec. 161.45 Waivers, and Sec. 161.60 Minor uses.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.30  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 161, 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 161 with respect to that product until he receives a notice under 
section 3(c)(2)(B) of the

[[Page 195]]

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. 161.75) 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 
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. 
161.160.
    (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. 
161.160.
    (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. 161.32  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

[[Page 196]]

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. 161.33;
    (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. 161.34(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 must be identical and must conform to the requirements of 
Sec. 161.33 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. 161.33  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)

[[Page 197]]

(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.


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. 161.34  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 paragraph 
(c) of this section when any criterion is met or exceeded.

[[Page 198]]



                                            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 <=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
----------------------------------------------------------------------------------------------------------------
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 161.34 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 161.34 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. 161.35  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. 161.20(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

[[Page 199]]

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. 161.40.
    (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. 161.45.
    (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. 161.75.
    (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. 
161.60.
    (e) The data requirements and guidelines are not static documents. 
Section 3(c)(2) of FIFRA states that the administrator ``shall revise 
such guidelines 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. 161.80.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988]



Sec. 161.40  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. 161.45  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.

[[Page 200]]

    (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 
OPP Regulatory Public Docket located as set forth in 40 CFR 150.17(c). 
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; 71 
FR 35545, June 21, 2006]



Sec. 161.55  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. 161.60  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 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. 161.70  Acceptable protocols.

    The Agency has published Pesticide Assessment Guidelines, as 
indicated in Sec. 161.20(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 requirements and 
recommendations of the applicable OECD protocols can be

[[Page 201]]

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. 161.75  Requirements for additional data.

    (a) General policy. The data routinely required by part 161 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. 161.80  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 part would be satisfactory 
to support applications provided good laboratory

[[Page 202]]

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. 161.85  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

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.100  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. 161.150 through 161.640). 
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. 161.108.
    (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

[[Page 203]]

required data for the pesticide product 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. 161.101  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. 161.45 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. 161.45.
    (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. 161.102  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. 161.108  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 (703-605-6000). The following Subdivisions of the 
Pesticide

[[Page 204]]

Assessment Guidelines, referenced to the appropriate sections of this 
part, are currently available:

----------------------------------------------------------------------------------------------------------------
                                                                                    Corresponding section(s) in
            Subdivision                      Title              NTIS order no.               this part
----------------------------------------------------------------------------------------------------------------
D                                    Product Chemistry      PB83-153890                       161.150 - 161.190
----------------------------------------------------------------------------------------------------------------
E                                    Hazard Evaluation:     PB83-153908                                 161.490
                                      Wildlife and Aquatic
                                      Organisms
----------------------------------------------------------------------------------------------------------------
F                                    Hazard Evaluation:     PB83-153916                                 161.340
                                      Humans and Domestic
                                      Animals
----------------------------------------------------------------------------------------------------------------
G                                    Product Performance    PB83-153924                                 161.640
----------------------------------------------------------------------------------------------------------------
I                                    Experimental Use       PB83-153932                        161.20 - 161.640
                                      Permits
----------------------------------------------------------------------------------------------------------------
J                                    Hazard Evaluation:     PB83-153940                                 161.540
                                      Nontarget Plants
----------------------------------------------------------------------------------------------------------------
K                                    Reentry Protection     PB85-120962                                 161.390
----------------------------------------------------------------------------------------------------------------
L                                    Hazard Evaulation:     PB83-153957                                 161.590
                                      Nontarget Insect
----------------------------------------------------------------------------------------------------------------
N                                    Environmental Fate     PB83-153973                                 161.290
----------------------------------------------------------------------------------------------------------------
O                                    Residue Chemistry      PB83-153961                                 161.240
----------------------------------------------------------------------------------------------------------------
R                                    Spray Drift            PB84-189216                                 161.440
                                      Evaluation
----------------------------------------------------------------------------------------------------------------


[72 FR 60255, Oct. 24, 2007]



              Subpart C_Product Chemistry Data Requirements

    Source: 53 FR 15993, May 4, 1988, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.150  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,

[[Page 205]]

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. 161.175 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 
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. 161.155 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. 161.175).
    (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. 161.153  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

[[Page 206]]

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
    (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. 161.155  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. 161.175.
    (2) If the source of any active ingredient in the product is not an 
EPA-registered product:

[[Page 207]]

    (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. 
161.175.
    (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 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. 
161.175.
    (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. 161.175.
    (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. 161.160  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.

[[Page 208]]

    (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 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. 161.162  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. 
161.165.
    (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. 161.165  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 161.162(b)(2), pertaining to characterization of the 
process.
    (b) Section 161.162(b)(4), pertaining to ingredients used in the 
process.
    (c) Section 161.162(b)(5), pertaining to process equipment.

[[Page 209]]

    (d) Section 161.162(b)(6), pertaining to the conditions of the 
process.
    (e) Section 161.162(b)(8), pertaining to quality control measures.



Sec. 161.167  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 
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. 161.170  Preliminary analysis.

    (a) If the product is produced by an integrated system, the 
applicant must

[[Page 210]]

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.



Sec. 161.175  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.

[[Page 211]]

    (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. [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. 161.180  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. 161.190  Physical and chemical characteristics.

    (a) Table. Sections 161.100 through 161.102 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.


[[Page 212]]


[49 FR 42881, Oct. 24, 1984, as amended at 58 FR 34203, June 23, 1993]



                    Subpart D_Data Requirement Tables

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted. 
Redesignated and amended at 72 FR 60253-60255, Oct. 24, 2007.



Sec. 161.202  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

[[Page 213]]

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 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, subchronic 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.

[[Page 214]]

    (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 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

[[Page 215]]

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 216]]



Sec. 161.240  Residue chemistry data requirements.

    (a) Table. Sections 161.100 through 161.102 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),                                                                                                          metaboli