[Title 40 CFR ]
[Code of Federal Regulations (annual edition) - July 1, 2000 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

                    40


          Parts 150 to 189

                         Revised as of July 1, 2000

Protection of Environment





          Containing a Codification of documents of general 
          applicability and future effect
          As of July 1, 2000
          With Ancillaries
          Published by
          the Office of the Federal Register
          National Archives and Records
          Administration

As a Special Edition of the Federal Register



[[Page ii]]



                                      




                     U.S. GOVERNMENT PRINTING OFFICE
                            WASHINGTON : 2000



               For sale by U.S. Government Printing Office
 Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328



[[Page iii]]




                            Table of Contents



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

  Title 40:
          Chapter I--Environmental Protection Agency--
          (Continued)                                                3
  Finding Aids:
      Material Approved for Incorporation by Reference........     541
      Table of CFR Titles and Chapters........................     543
      Alphabetical List of Agencies Appearing in the CFR......     561
      Pesticide Tolerance Commodity/Chemical Index............     570
      Crop Grouping Commodities Index.........................     677
      Redesignation Table.....................................     683
      List of CFR Sections Affected...........................     685



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

                     Cite this Code:  CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus,  40 CFR 152.1 refers 
                       to title 40, part 152, 
                       section 1.

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

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    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, 2000), 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 
exercised by the user in determining the actual effective date. In 
instances where the effective date is beyond the cut-off date for the 
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, 1986, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, or 1973-1985, published in seven separate volumes. For 
the period beginning January 1, 1986, a ``List of CFR Sections 
Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
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.
    Properly approved incorporations by reference in this volume are 
listed in the Finding Aids at the end of this volume.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed in 
the Finding Aids of this volume as an approved incorporation by 
reference, please contact the agency that issued the regulation 
containing that incorporation. If, after contacting the agency, you find 
the material is not available, please notify the Director of the Federal 
Register, National Archives and Records Administration, Washington DC 
20408, or call (202) 523-4534.

CFR INDEXES AND TABULAR GUIDES

    A subject index to the Code of Federal Regulations is contained in a 
separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Statutory 
Authorities and Agency Rules (Table I). A list of CFR titles, chapters, 
and parts and an alphabetical list of agencies publishing in the CFR are 
also included in this volume.
    An index to the text of ``Title 3--The President'' is carried within 
that volume.
    The Federal Register Index is issued monthly in cumulative form. 
This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.

[[Page vii]]


REPUBLICATION OF MATERIAL

    There are no restrictions on the republication of material appearing 
in the Code of Federal Regulations.

INQUIRIES

    For a legal interpretation or explanation of any regulation in this 
volume, contact the issuing agency. The issuing agency's name appears at 
the top of odd-numbered pages.
    For inquiries concerning CFR reference assistance, call 202-523-5227 
or write to the Director, Office of the Federal Register, National 
Archives and Records Administration, Washington, DC 20408 or e-mail 
info@fedreg.nara.gov.

SALES

    The Government Printing Office (GPO) processes all sales and 
distribution of the CFR. For payment by credit card, call 202-512-1800, 
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Customer Service call 202-512-1803.

ELECTRONIC SERVICES

    The full text of the Code of Federal Regulations, The United States 
Government Manual, the Federal Register, Public Laws, Public Papers, 
Weekly Compilation of Presidential Documents and the Privacy Act 
Compilation are available in electronic format at www.access.gpo.gov/
nara (``GPO Access''). For more information, contact Electronic 
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Phone 202-512-1530, or 888-293-6498 (toll-free). E-mail, 
gpoaccess@gpo.gov.
    The Office of the Federal Register also offers a free service on the 
National Archives and Records Administration's (NARA) World Wide Web 
site for public law numbers, Federal Register finding aids, and related 
information. Connect to NARA's web site at www.nara.gov/fedreg. The NARA 
site also contains links to GPO Access.

                              Raymond A. Mosley,
                                    Director,
                          Office of the Federal Register.

July 1, 2000.



[[Page ix]]



                               THIS TITLE

    Title 40--Protection of Environment is composed of twenty-four 
volumes. The parts in these volumes are arranged in the following order: 
parts 1-49, parts 50-51, part 52 (52.01-52.1018), part 52 (52.1019-End), 
parts 53-59, part 60, parts 61-62, part 63 (63.1-63.1199), part 63 
(63.1200-End), parts 64-71, parts 72-80, parts 81-85, part 86, parts 87-
135, parts 136-149, parts 150-189, parts 190-259, parts 260-265, parts 
266-299, parts 300-399, parts 400-424, parts 425-699, parts 700-789, and 
part 790 to End. The contents of these volumes represent all current 
regulations codified under this title of the CFR as of July 1, 2000.

    Chapter I--Environmental Protection Agency appears in all twenty-
four volumes. A Pesticide Tolerance Commodity/Chemical Index and Crop 
Grouping Commodities Index appear in parts 150-189. A Toxic Substances 
Chemical--CAS Number Index appears in parts 700-789 and part 790 to End. 
Redesignation Tables appear in the volumes containing parts 50-51, parts 
150-189, and parts 700-789. Regulations issued by the Council on 
Environmental Quality appear in the volume containing part 790 to End. 
The OMB control numbers for title 40 appear in Sec. 9.1 of this chapter.

    For this volume, Bonnie J. Fritts was Chief Editor. The Code of 
Federal Regulations publication program is under the direction of 
Frances D. McDonald, assisted by Alomha S. Morris.

[[Page x]]





[[Page 1]]



                   TITLE 40--PROTECTION OF ENVIRONMENT




                  (This book contains parts 150 to 189)

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

chapter i--Environmental Protection Agency (Continued)......         152

[[Page 3]]



                   CHAPTER I--ENVIRONMENTAL PROTECTION






                           AGENCY--(Continued)




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

                    SUBCHAPTER E--PESTICIDE PROGRAMS

Part                                                                Page
150-151

[Reserved]  

152             Pesticide registration and classification 
                    procedures..............................           5
153             Registration policies and interpretations...          41
154             Special review procedures...................          42
155             Registration standards......................          50
156             Labeling requirements for pesticides and 
                    devices.................................          53
157             Packaging requirements for pesticides and 
                    devices.................................          69
158             Data requirements for registration..........          73
159             Statements of policies and interpretations..         125
160             Good laboratory practice standards..........         138
162             State registration of pesticide products....         150
163             Certification of usefulness of pesticide 
                    chemicals...............................         158
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........         161
166             Exemption of Federal and State agencies for 
                    use of pesticides under emergency 
                    conditions..............................         179
167             Registration of pesticide and active 
                    ingredient producing establishments, 
                    submission of pesticide reports.........         188
168             Statements of enforcement policies and 
                    interpretations.........................         190
169             Books and records of pesticide production 
                    and distribution........................         201
170             Worker protection standard..................         203
171             Certification of pesticide applicators......         231
172             Experimental use permits....................         248
173             Procedures governing the rescission of State 
                    primary enforcement responsibility for 
                    pesticide use violations................         264

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177             Issuance of food additive regulations.......         266
178             Objections and requests for hearings........         272
179             Formal evidentiary public hearing...........         275
180             Tolerances and exemptions from tolerances 
                    for pesticide chemicals in food.........         287
187-189

[Reserved]

[[Page 5]]





                    SUBCHAPTER E--PESTICIDE PROGRAMS



                        PARTS 150-151 [RESERVED]



PART 152--PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of Contents




                      Subpart A--General Provisions

Sec.
152.1  Scope.
152.3  Definitions.
152.5  Pests.
152.8  Products that are not pesticides because they are not for use 
          against pests.
152.10  Products that are not pesticides because they are not deemed to 
          be used for a pesticidal effect.
152.15  Pesticide products required to be registered.

                          Subpart B--Exemptions

152.20  Exemptions for pesticides regulated by another Federal agency.
152.25  Exemptions for pesticides of a character not requiring FIFRA 
          regulation.
152.30  Pesticides that may be transferred, sold, or distributed without 
          registration.

                   Subpart C--Registration Procedures

152.40  Who may apply.
152.42  Application for new registration.
152.43  Alternate formulations.
152.44  Application for amended registration.
152.46  Notification and non-notification changes to registrations.
152.50  Contents of application.
152.55  Where to send applications and correspondence.

Subpart D [Reserved]

  Subpart E--Procedures To Ensure Protection of Data Submitters' Rights

152.80  General.
152.81  Applicability.
152.83  Definitions.
152.84  When materials must be submitted to the Agency.
152.85  Formulators' exemption.
152.86  The cite-all method.
152.90  The selective method.
152.91  Waiver of a data requirement.
152.92  Submission of a new valid study.
152.93  Citation of a previously submitted valid study.
152.94  Citation of a public literature study or study generated at 
          government expense.
152.95  Citation of all studies in the Agency's files pertinent to a 
          specific data requirement.
152.96  Documentation of a data gap.
152.97  Rights and obligations of data submitters.
152.98  Procedures for transfer of exclusive use or compensation rights 
          to another person.
152.99  Petitions to cancel registration.

                Subpart F--Agency Review of Applications

152.100  Scope.
152.102  Publication.
152.104  Completeness of applications.
152.105  Incomplete applications.
152.107  Review of data.
152.108  Review of labeling.
152.110  Time for Agency review.
152.111  Choice of standards for review of applications.
152.112  Approval of registration under FIFRA sec. 3(c)(5).
152.113  Approval of registration under FIFRA sec. 3(c)(7)--Products 
          that do not contain a new active ingredient.
152.114  Approval of registration under FIFRA sec. 3(c)(7)--Products 
          that contain a new active ingredient.
152.115  Conditions of registration.
152.116  Notice of intent to register to original submitters of 
          exclusive use data.
152.117  Notification to applicant.
152.118  Denial of application.
152.119  Availability of material submitted in support of registration.

            Subpart G--Obligations and Rights of Registrants

152.122  Currency of address of record and authorized agent.
152.125  Submission of information pertaining to adverse effects.
152.130  Distribution under approved labeling.
152.132  Supplemental distribution.
152.135  Transfer of registration.

Subpart H [Reserved]

                 Subpart I--Classification of Pesticides

152.160  Scope.
152.161  Definitions.
152.164  Classification procedures.
152.166  Labeling of restricted use products.
152.167  Distribution and sale of restricted use products.
152.168  Advertising of restricted use products.
152.170  Criteria for restriction to use by certified applicators.

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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.

    Part 152 sets forth procedures, requirements and criteria concerning 
the registration and reregistration of pesticide products under FIFRA 
sec. 3, and for associated regulatory activities affecting registration. 
These latter regulatory activities include data compensation and 
exclusive use (subpart E), and the classification of pesticide uses 
(subpart I).

[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



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.
    (a) Act or FIFRA means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (7 U.S.C. 136-136y).
    (b) 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).
    (c) 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.
    (d) 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.
    (e) Acute oral LD50 means a statistically derived 
estimate of the single oral dose of a substance that would cause 50 
percent mortality to the test population under specified conditions.
    (f) Administrator means the Administrator of the United States 
Environmental Protection Agency or his delegate.
    (g) Agency means the United States Environmental Protection Agency 
(EPA), unless otherwise specified.
    (h) Applicant means a person who applies for a registration, amended 
registration, or reregistration, under FIFRA sec. 3.
    (i) 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.
    (j) 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.
    (k) 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.
    (l) Final printed labeling means the label or labeling of the 
product when

[[Page 7]]

distributed or sold. Final printed labeling does not include the package 
of the product, unless the labeling is an integral part of the package.
    (m) 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.
    (n) 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.
    (o) Manufacturing use product means any pesticide product that is 
not an end-use product.
    (p) New use, when used with respect to a product containing a 
particular active ingredient, means:
    (1) Any proposed use pattern that would require the establishment 
of, the increase in, or the exemption from the requirement of, a 
tolerance or food additive regulation under section 408 or 409 of the 
Federal Food, Drug and Cosmetic Act;
    (2) Any aquatic, terrestrial, outdoor, or forestry use pattern, if 
no product containing the active ingredient is currently registered for 
that use pattern; or
    (3) Any additional use pattern that would result in a significant 
increase in the level of exposure, or a change in the route of exposure, 
to the active ingredient of man or other organisms.
    (q) 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.
    (r) 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.
    (s) 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.
    (t) 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.
    (u) 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.



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

[[Page 8]]

order, and any plant part such as a root; or
    (d) Any fungus, bacterium, virus, or other microorganisms, except 
for those on or in living man or other living animals and those on or in 
processed food or processed animal feed, beverages, drugs (as defined in 
FFDCA sec. 201(g)(1)) and cosmetics (as defined in FFDCA sec. 201(i)).



Sec. 152.8  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 product intended for use only for the control of fungi, 
bacteria, viruses, or other microorganisms in or on living man or 
animals, and labeled accordingly.
    (b) A product intended for use only for control of internal 
invertebrate parasites or nematodes in living man or animals, and 
labeled accordingly.
    (c) A product of any of the following types, intended only to aid 
the growth of desirable plants:
    (1) A fertilizer product not containing a pesticide.
    (2) 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.
    (3) A plant inoculant product consisting of microorganisms applied 
to the plant or soil for the purpose of enhancing the availiability or 
uptake of plant nutrients through the root system.
    (4) A soil amendment product containing a substance or substances 
added to the soil for the purpose of improving soil characteristics 
favorable for plant growth.
    (d) A product intended to force bees from hives for the collection 
of honey crops.



Sec. 152.10  Products that are not pesticides because they are not deemed to be used for a pesticidal effect.

    A product that is not intended to prevent, destroy, repel, or 
mitigate a pest, or to defoliate, desiccate or regulate the growth of 
plants, is not considered to be a pesticide. The following types of 
products or articles are not considered to be pesticides unless a 
pesticidal claim is made on their labeling or in connection with their 
sale and distribution:
    (a) Deodorizers, bleaches, and cleaning agents;
    (b) Products not containing toxicants, intended only to attract 
pests for survey or detection purposes, and labeled accordingly;
    (c) Products that are intended to exclude pests only by providing a 
physical barrier against pest access, and which contain no toxicants, 
such as certain pruning paints to trees.



Sec. 152.15  Pesticide products required to be registered.

    No person may distribute or sell any pesticide product that is not 
registered under the Act, except as provided in Secs. 152.20, 152.25, 
and 152.30. A pesticide is any substance (or mixture of substances) 
intended for a pesticidal purpose, i.e., use for the purpose of 
preventing, destroying, repelling, or mitigating any pest or use as a 
plant regulator, defoliant, or desiccant. A substance is considered to 
be intended for a pesticidal purpose, and thus to be a pesticide 
requiring registration, if:
    (a) The person who distributes or sells the substance claims, 
states, or implies (by labeling or otherwise):
    (1) That the substance (either by itself or in combination with any 
other substance) can or should be used as a pesticide; or
    (2) That the substance consists of or contains an active ingredient 
and that it can be used to manufacture a pesticide; or
    (b) The substance consists of or contains one or more active 
ingredients 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.

[[Page 9]]



                          Subpart B--Exemptions

    Source: 53 FR 15977, May 4, 1988, unless otherwise noted.



Sec. 152.20  Exemptions for pesticides regulated by another Federal agency.

    The pesticides or classes of pesticide listed in this section are 
exempt from all requirements of FIFRA. The Agency has determined, in 
accordance with FIFRA sec. 25(b)(1), that they are adequately regulated 
by another Federal agency.
    (a) Certain biological control agents. (1) Except as provided by 
paragraph (a)(3) of this section, all biological control agents are 
exempt from FIFRA requirements.
    (2) If the Agency determines that an individual biological control 
agent or class of biological control agents is no longer adequately 
regulated by another Federal agency, and that it should not otherwise be 
exempted from the requirements of FIFRA, the Agency will revoke this 
exemption by amending paragraph (a)(3) of this section.
    (3) The following biological control agents are not exempt from 
FIFRA requirements:
    (i) Eucaryotic microorganisms, including protozoa, algae and fungi;
    (ii) Procaryotic microorganisms, including bacteria; and
    (iii) Viruses.
    (b) Certain human drugs. A pesticide product that is offered solely 
for human use and also is a new drug within the meaning of FFDCA sec. 
201(p) or is an article that has been determined by the Secretary of 
Health and Human Services not to be a new drug by a regulation 
establishing conditions of use for the article, is exempt from the 
requirements of FIFRA. Such products are subject to regulation in 
accordance with the Federal Food, Drug, and Cosmetic Act and 
implementing regulations.



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 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.

[[Page 10]]

    (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) Vitamin hormone products. Vitamin hormone horticultural products 
consisting of mixtures of plant hormones, plant nutrients, inoculants, 
or soil amendments, which meet the following criteria:
    (1) The product, in the undiluted package concentration at which it 
is distributed or sold, meets the criteria of Sec. 156.10(h)(1) 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.
    (e) Foods. Products consisting of foods and containing no active 
ingredients, which are used to attract pests.
    (f) 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.
    (g) Minimum risk pesticides--(1) Exempted products. Products 
containing the following active ingredients are exempt from the 
requirements of FIFRA, alone or in combination with other substances 
listed in this paragraph, provided that all of the criteria of this 
section are met.

Castor oil (U.S.P. or equivalent)
Cedar oil
Cinnamon and cinnamon oil
Citric acid
Citronella and citronella oil
Cloves and clove oil
Corn gluten meal
Corn oil
Cottonseed oil
Dried blood
Eugenol
Garlic and garlic oil
Geraniol
Geranium oil
Lauryl sulfate
Lemongrass oil
Linseed oil
Malic acid
Mint and mint oil
Peppermint and peppermint oil
2-Phenethyl propionate (2-phenylethyl propionate)
Potassium sorbate
Putrescent whole egg solids
Rosemary and rosemary oil
Sesame (includes ground sesame plant) and sesame oil
Sodium chloride (common salt)
Sodium lauryl sulfate
Soybean oil
Thyme and thyme oil
White pepper
Zinc metal strips (consisting solely of zinc metal and impurities)

    (2) Permitted inerts. A pesticide product exempt under paragraph 
(g)(1) of this section may only include inert ingredients listed in the 
most current List 4A. This list is updated periodically and is published 
in the Federal Register. The most current list may be obtained by 
writing to Registration Support Branch (4A Inerts List) Registration 
Division (7505C), Office of Pesticide Programs, Environmental Protection 
Agency, 401 M St., SW., Washington DC 20460.
    (3) Other conditions of exemption. All of the following conditions 
must be met for products to be exempted under this section:
    (i) Each product containing the substance must bear a label 
identifying the name and percentage (by weight) of each active 
ingredient and the name of each inert ingredient.
    (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

[[Page 11]]

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]



Sec. 152.30  Pesticides that may be transferred, sold, or distributed without registration.

    An unregistered pesticide, or a pesticide whose registration has 
been cancelled or suspended, may be dis-tributed or sold, or otherwise 
transferred, to the extent described by this section.
    (a) A pesticide transferred between registered establishments 
operated by the same producer. An unregistered pesticide may be 
transferred between registered establishments operated by the same 
producer. The pesticide as transferred must be labeled in accordance 
with part 156 of this chapter.
    (b) A pesticide transferred between registered establishments not 
operated by the same producer. An unregistered pesticide may be 
transferred between registered establishments not operated by the same 
producer if:
    (1) The transfer is solely for the purpose of further formulation, 
packaging, or labeling into a product that is registered;
    (2) Each active ingredient in the pesticide, at the time of 
transfer, is present as a result of incorporation into the pesticide of 
either:
    (i) A registered product; or
    (ii) A pesticide that is produced by the registrant of the final 
product; and
    (3) The product as transferred is labeled in accordance with part 
156 of this chapter.
    (c) A pesticide distributed or sold under an experimental use 
permit. (1) An unregistered pesticide may be distributed or sold in 
accordance with the terms of an experimental use permit issued under 
FIFRA sec. 5, if the product is labeled in accordance with Sec. 172.6 of 
this chapter.
    (2) An unregistered pesticide may be distributed or sold in 
accordance with the provisions of Sec. 172.3 of this chapter, pertaining 
to use of a pesticide for which an experimental use permit is not 
required, provided the product is labeled in accordance with part 156 of 
this chapter.
    (d) A pesticide transferred solely for export. An unregistered 
pesticide may be transferred within the United States solely for export 
if it meets the following conditions:
    (1) The product is prepared and packaged according to the 
specifications of the foreign purchaser; and
    (2) The product is labeled in accordance with part 156 of this 
chapter.
    (e) A pesticide distributed or sold under an emergency exemption. An 
unregistered pesticide may be distributed or sold in accordance with the 
terms of an emergency exemption under FIFRA sec. 18, if the product is 
labeled in accordance with part 156 of this chapter.
    (f) A pesticide transferred for purposes of disposal. An 
unregistered, suspended, or cancelled pesticide may be transferred 
solely for disposal in accordance with FIFRA sec. 19 or an applicable 
Administrator's order. The product must be labeled in accordance with 
part 156 of this chapter.
    (g) Existing stocks of a formerly registered product. A cancelled or 
suspended pesticide may be distributed or sold to the extent and in the 
manner specified in an order issued by the Administrator concerning 
existing stocks of the pecticide.



                   Subpart C--Registration Procedures

    Source: 53 FR 15978, May 4, 1988, unless otherwise noted.



Sec. 152.40  Who may apply.

    Any person may apply for new registration of a pesticide product. 
Any registrant may apply for amendment of the registration of his 
product.



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

[[Page 12]]

the Agency before the product may legally be distributed or sold, except 
as provided by Sec. 152.30.



Sec. 152.43  Alternate formulations.

    (a) A product proposed for registration must have a single, defined 
composition, except that EPA may approve a basic formulation and one or 
more alternate formulations for a single product.
    (b) An alternate formulation must meet the criteria listed in 
paragraph (b) (1) through (4) of this section. The Agency may require 
the submission of data to determine whether the criteria have been met.
    (1) The alternate formulation must have the same certified limits 
for each active ingredient as the basic formulation.
    (2) If the alternate formulation contains an inert ingredient or 
impurity of toxicological signficance, the formulation must have the 
same upper certified limit for that substance as the basic formulation;
    (3) The label text of the alternate formulation product must be 
identical to that of the basic formulation.
    (4) The analytical method required under Sec. 158.180 must be 
suitable for use on both the basic formulation and the alternate 
formulation.
    (c) Notwithstanding the criteria in this section, the Agency may 
determine that an alternate formulation must be separately registered. 
If EPA makes this determination, the Agency will notify the applicant of 
its determination and its reasons. Thereafter the application for an 
alternate formulation will be treated as an application for new 
registration, and the alternate formulation will be assigned a new 
registration number.



Sec. 152.44  Application for amended registration.

    (a) Except as provided by Sec. 152.46, any modification in the 
composition, labeling, or packaging of a registered product must be 
submitted with an application for amended registration. The applicant 
must submit the information required by Sec. 152.50, as applicable to 
the change requested. If an application for amended registration is 
required, the application must be approved by the Agency before the 
product, as modified, may legally be distributed or sold.
    (b) In its discretion, the Agency may:
    (1) Waive the requirement for submission of an application for 
amended registration;
    (2) Require that the applicant certify to the Agency that he has 
complied with an Agency directive rather than submit an application for 
amended registration; or
    (3) Permit an applicant to consolidate an amendment affecting a 
number of products into a single application.
    (4) Permit an applicant to modify a registration by notification or 
non-notification in accordance with Sec. 152.46.

[53 FR 15978, May 4, 1988, as amended at 61 FR 33041, June 26, 1996]



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

[[Page 13]]

minor modifications to registration having no potential to cause 
unreasonable adverse effects to the environment may be accomplished 
without notification to or approval by the Agency. If EPA so determines, 
it will issue procedures following an opportunity for public comment 
describing the types of amendments permitted without notification (also 
known as non-notification). A registrant may distribute or sell a 
product changed in a manner consistent with such procedures without 
notification to or approval by the Agency.
    (c) Effect of non-compliance. Notwithstanding any other provision of 
this section, if the Agency determines that a product has been modified 
through notification or without notification in a manner inconsistent 
with paragraphs (a) or (b) of this section and any procedures issued 
thereunder, the Agency may initiate regulatory and/or enforcement action 
without first providing the registrant with an opportunity to submit an 
application for amended registration.

[61 FR 33041, June 26, 1996]



Sec. 152.50  Contents of application.

    Each application for registration or amended registration must 
include the following information, as applicable:
    (a) Application form. An application form must be completed and 
submitted to the Agency. Application forms are provided by the Agency, 
with instructions as to the number of copies required and proper 
completion.
    (b) Identity of the applicant--(1) Name. The applicant must identify 
himself. An applicant not residing in the United States must also 
designate an agent in accordance with paragraph (b)(3) of this section 
to act on behalf of the applicant on all registration matters.
    (2) Address of record. The applicant must provide an address in the 
United States for correspondence purposes. The U.S. address provided 
will be considered the applicant's address of record, and EPA will send 
all correspondence concerning the application and any subsequent 
registration to that address. It is the responsibility of the applicant 
and any registrant under Sec. 152.122 to ensure that the Agency has a 
current and accurate address.
    (3) Authorized agent. An applicant may designate a person residing 
in the United States to act as his agent. If an applicant wishes to 
designate an agent, he must send the Agency a letter stating the name 
and United States address of his agent. The applicant must notify the 
Agency if he changes his designated agent. This relationship may be 
terminated at any time by the applicant by notifying the Agency in 
writing.
    (4) Company number. If an applicant has been assigned a company 
number by the Agency, the application must reference that number.
    (c) Summary of the application. Each application must include a list 
of the data submitted with the application, together with a brief 
description of the results of the studies. The list of data submitted 
may be the same as the list required by Sec. 158.32 of this chapter. The 
summary must state that is is releasable to the public after 
registration in accordance with Sec. 152.119.
    (d) Identity of the product. The product for which application is 
being submitted must be identified. The following information is 
required:
    (1) The product name;
    (2) The trade name(s) (if different); and
    (3) The EPA Registration Number, if currently registered.
    (e) Draft labeling. Each application for new registration must be 
accompanied by five legible copies of draft labeling (typescript or 
mock-up). Each application for amended registration that proposes to 
make any changes in the product labeling must be accompanied by five 
legible copies of draft labeling incorporating the proposed labeling 
changes. If the proposed labeling change affects only a portion of the 
labeling, such as the use directions, the applicant may submit five 
copies of that portion of the label which is the subject of the 
amendment. Upon request, an applicant for amended registration must 
submit a complete label to consolidate amendments.
    (f) Registration data requirements. (1) An applicant must submit 
materials to demonstrate that he has complied with the FIFRA sec. 
3(c)(1)(D) and subpart E of this part with respect to satisfaction of 
data requirements, to enable the

[[Page 14]]

Agency to make the determination required by FIFRA sec. 3(c)(5)(B). 
Required items are described in subpart E of this part.
    (2) An applicant must furnish any data specified in part 158 of this 
chapter which are required by the Agency to determine that the product 
meets the registration standards of FIFRA sec. 3(c) (5) or (7). Each 
study must comply with:
    (i) Section 158.30 of this chapter, with respect to times for 
submission;
    (ii) Section 158.32 of this chapter, with respect to format of 
submission;
    (iii) Section 158.33 of this chapter, with respect to studies for 
which a claim of trade secret or confidential business information is 
made;
    (iv) Section 158.34 of this chapter, with respect to flagging for 
potential adverse effects; and
    (v) Section 160.12 of this chapter, if applicable, with respect to a 
statement of whether studies were conducted in accordance with the Good 
Laboratory Practices of part 160.
    (3) An applicant shall furnish with his application any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on man or the environment, which would be required to 
be reported under FIFRA sec. 6(a)(2) if the product were registered.
    (g) Certification relating to child-resistant packaging. If the 
product meets the criteria for child-resistant packaging, the applicant 
must submit a certification that the product will be distributed or sold 
only in child-resistant packaging. Refer to part 157 of this chapter for 
the criteria and certification requirements.
    (h) Request for classification. If an applicant wishes to request a 
classification different from that established by the Agency, he must 
submit a request for such classification and information supporting the 
request.
    (i) Statement concerning tolerances. If the proposed labeling bears 
instructions for use of the pesticide on food or feed crops, or if the 
intended use of the pesticide results or may be expected to result, 
directly or indirectly, in pesticide residues in or on food or feed 
(including residues of any active ingredient, inert ingredient, 
metabolite, or degradation product), the applicant must submit a 
statement indicating whether such residues are authorized by a 
tolerance, exemption from the requirement of a tolerance, or food 
additive regulation issued under section 408 or 409 of the Federal Food, 
Drug and Cosmetic Act (FFDCA). If such residues have not been 
authorized, the application must be accompanied by a petition for 
establishment of appropriate tolerances, exemptions from the requirement 
of a tolerance, or food additive regulations, in accordance with part 
180 of this chapter.

[53 FR 15978, May 4, 1988, as amended at 58 FR 34203, June 23, 1993; 60 
FR 32096, June 19, 1995]



Sec. 152.55  Where to send applications and correspondence.

    Applications and correspondence relating to registration should be 
mailed to the Registration Division (TS-767C), U.S. Environmental 
Protection Agency, Washington, DC 20460. Persons who wish to hand-
deliver applications should contact the Registration Division to 
determine the location for delivery.

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 (Secs. 152.80 through 152.119)\1\ describes the 
information that an applicant must submit with his application for 
registration, amended registration, or reregistration to comply (and for 
the Agency to determine compliance) with the provisions of FIFRA section 
3(c)(1)(D). This subpart also describes the procedures by which data 
submitters may challenge registration actions which allegedly failed to 
comply with these procedures. If the Agency determines that an applicant

[[Page 15]]

has failed to comply with the requirements and procedures in this 
subpart, the application may be denied. If the Agency determines, after 
registration has been issued, that an applicant failed to comply with 
these procedures and requirements, the Agency may issue a notice of 
intent to cancel the product's registration.
---------------------------------------------------------------------------

    \1\ Editorial Note: Sections 152.116 and 152.119 were transferred to 
subpart F at 53 FR 15980, May 4, 1988.

[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.81  Applicability.

    (a) Except as provided in paragraph (b) of this section, 
Secs. 152.83 through 152.119 apply to:
    (1) Each application for registration of a new product;
    (2) Each application for an amendment of a registration; and
    (3) Each application for reregistration under FIFRA section 3(g).
    (b) This subpart E does not apply to:
    (1) Applications for registration submitted to States under FIFRA 
section 24(c);
    (2) Applications for experimental use permits under FIFRA section 5;
    (3) Applications for emergency exemptions under FIFRA section 18;
    (4) Applications to make only one or more of the following types of 
amendments to existing registrations, unless the Administrator or his 
designee finds that Agency consideration of scientific data would be 
necessary in order to approve the amendment under FIFRA section 3(c)(5):
    (i) An increase or decrease in the percentage in the product of one 
or more of its active ingredients or deliberately added inert 
ingredients;
    (ii) A revision of the identity or amount of impurities present in 
the product;
    (iii) The addition or deletion of one or more deliberately added 
inert ingredients;
    (iv) The deletion of one or more active ingredients;
    (v) A change in the source of supply of one or more of the active 
ingredients used in the product, if the new source of the active 
ingredient is a product which is registered under FIFRA section 3;
    (vi) Deletion of approved uses of claims;
    (vii) Redesign of the label format involving no substantive changes, 
express or implied, in the directions for use, claims, representations, 
or precautionary statements;
    (viii) Change in the product name or addition of an additional brand 
name, if no additional claims, representations, or uses are expressed or 
implied by the changes;
    (ix) Clarification of directions for use;
    (x) Correction of typographical errors;
    (xi) Changes in the registrant's name or address;
    (xii) Adding or deleting supplemental registrants;
    (xiii) Changes in the package or container size;
    (xiv) Changes in warranty, warranty disclaimer, or liability 
limitation statements, or addition to or deletion of such statements;
    (xv) ``Splitting'' a label for the sole purpose of facilitating the 
marketing of a product in different geographic regions with appropriate 
labels, where each amended label will contain previously approved use 
instructions (and related label statements) appropriate to a particular 
geographic region;
    (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:

[[Page 16]]

    (a) Data gap means the absence of any valid study or studies in the 
Agency's files which would satisfy a specific data requirement for a 
particular pesticide product.
    (b) Data Submitters List means the current Agency list, entitled 
``Pesticide Data Submitters by Chemical,'' of persons who have submitted 
data to the Agency.
    (c) Exclusive use study means a study that meets each of the 
following requirements:
    (1) The study pertains to a new active ingredient (new chemical) or 
new combination of active ingredients (new combination) first registered 
after September 30, 1978;
    (2) The study was submitted in support of, or as a condition of 
approval of, the application resulting in the first registration of a 
product containing such new chemical or new combination (first 
registration), or an application to amend such registration to add a new 
use; and
    (3) The study was not submitted to satisfy a data requirement 
imposed under FIFRA section 3(c)(2)(B);
    Provided that, a study is an exclusive use study only during the 10-
year period following the date of the first registration.
    (d) Original data submitter means the person who possesses all 
rights to exclusive use or compensation under FIFRA section 3(c)(1)(D) 
in a study originally submitted in support of an application for 
registration, amended registration, reregistration, or experimental use 
permit, or to maintain an existing registration in effect. The term 
includes the person who originally submitted the study, any person to 
whom the rights under FIFRA section 3(c)(1)(D) have been transferred, or 
the authorized representative of a group of joint data developers.
    (e) Valid study means a study that has been conducted in accordance 
with the Good Laboratory Practice standards of 40 CFR part 160 or 
generally accepted scientific methodology and that EPA has not 
determined to be invalid.



Sec. 152.84  When materials must be submitted to the Agency.

    All information required by this subpart should be submitted with 
the application, but may be submitted at any later time prior to EPA's 
approval of the application. The Agency will not approve any application 
until it determines either that the application is not subject to these 
requirements or that all required materials have been submitted and are 
acceptable.



Sec. 152.85  Formulators' exemption.

    (a) FIFRA section 3(c)(2)(D) excuses an applicant from the 
requirement to submit or cite data pertaining to the safety of any 
ingredient (or mixture of ingredients) contained in his product that is 
derived solely from one or more EPA-registered products which the 
applicant purchases from another producer.
    (b) If the product contains one or more ingredients eligible for the 
formulators' exemption, the applicant need not comply with the 
requirements of Secs. 152.90 through 152.96 with respect to any data 
requirements pertaining to the safety of any such ingredient, provided 
that he submits to the Agency a certification statement containing the 
following information (a form for this purpose is available from the 
Agency):
    (1) Identification of the applicant, and of the product by EPA 
registration number or file symbol;
    (2) Identification of each ingredient in the pesticide that is 
eligible for the formulators' exemption, and the EPA registration number 
of the product that is the source of that ingredient;
    (3) A statement that the listed ingredients meet the requirements 
for the formulators' exemption;
    (4) A statement that the applicant has submitted (either previously 
or with the current application) a complete, accurate and current 
Confidential Statement of Formula; and
    (5) The name, title and signature of the applicant or his authorized 
representative and the date of signature.
    (c) An applicant for amended registration is not required to submit 
a new formulators' exemption statement, if the current statement in 
Agency files is complete and accurate.

[49 FR 30903, Aug. 1, 1984, as amended at 58 FR 34203, June 23, 1993; 60 
FR 32096, June 19, 1995]

[[Page 17]]



Sec. 152.86  The cite-all method.

    An applicant may comply with this subpart by citing all data in 
Agency files that are pertinent to its consideration of the requested 
registration under FIFRA section 3(c)(5), in accordance with the 
procedures in this section, as applicable.
    (a) Exclusive use studies. The applicant must certify to the Agency 
that he has obtained, from each person listed on the Data Submitters 
List as an exclusive use data submitter for the chemical in question, a 
written authorization that contains at least the following information:
    (1) Identification of the applicant to whom the authorization is 
granted;
    (2) Authorization to the applicant to use all pertinent studies in 
satisfaction of data requirements for the application in question; and
    (3) The signature and title of the original data submitter or his 
authorized representative and date of the authorization.

If the Agency identifies any exclusive use data submitter not on the 
Data Submitters List, the applicant will be required prior to 
registration to obtain the necessary written authorization from such 
person.
    (b) Other studies. The applicant must certify to the Agency that, 
with respect to each other person on the Data Submitters List for the 
chemical in question:
    (1) He has obtained from that person a written authorization that 
contains the information required by paragraphs (a) (1) through (3) of 
this section; or
    (2) He has furnished to that person:
    (i) A notification of his intent to apply for registration, 
including the name of the proposed product, and a list of the product's 
active ingredients;
    (ii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(D) for any data on which the application 
relies;
    (iii) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for the use of any study; and
    (iv) His name, address and telephone number.
    (c) General offer to pay statement. The applicant must submit to the 
Agency the following general offer to pay statement:

    [Name of applicant] hereby offers and agrees to pay compensation to 
other persons, with regard to the approval of this application, to the 
extent required by FIFRA section 3(c)(1)(D) of the Federal Insecticide, 
Fungicide and Rodenticide Act.

    (d) Acknowledgement of reliance on data. Each application filed 
under this section shall include an acknowledgement that for purposes of 
FIFRA section 3(c)(1)(D) the application relies on the following data:
    (1) All data submitted with or specifically cited in the 
application; and
    (2) Each other item of data in the Agency's files which:
    (i) Concerns the properties or effects of the applicant's product, 
of any product which is identical or substantially similar to the 
applicant's product, or of one or more of the active ingredients in the 
applicant's product; and
    (ii) Is one of the types of data that EPA would require to be 
submitted if the application sought the initial registration under FIFRA 
section 3(c)(5) of a product with composition and intended uses 
identical or substantially similar to the applicant's product, under the 
data requirements in effect on the date EPA approves the applicant's 
present application.



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

[[Page 18]]

applicant need not list data requirements pertaining to any ingredient 
which qualifies for the formulator's exemption.
    (1) If a Registration Standard has been issued for any active 
ingredient, the applicant must list the applicable data requirements 
enumerated in that Standard for the active ingredient and, if end use 
products are covered by the Registration Standard, for such products 
containing that active ingredient.
    (2) If a Registration Standard has not been issued, or if an issued 
Registration Standard does not cover all data requirements for products 
containing the active ingredient in question, the applicant must list 
the applicable requirements as prescribed by 40 CFR part 158. All 
required (R) studies, and any studies that could be conditionally 
required (CR) based upon composition, use pattern, or the results of 
required studies, are to be listed. The applicant may demonstrate via 
the data gap procedures in Sec. 152.96 that a conditional requirement 
need not be satisfied by the submission or citation of data at the time 
of application.
    (b) Methods of demonstrating compliance. The applicant must state 
for each data requirement on the list required by paragraph (a) of this 
section which of the following methods of compliance with the 
requirement he is using, and shall provide the supporting documentation 
specified in the referenced section.
    (1) Existence of or granting of a data waiver. Refer to Sec. 152.91.
    (2) Submission of a new valid study. Refer to Sec. 152.92.
    (3) Citation of a specific valid study previously submitted to the 
Agency by the applicant or another person, with any necessary written 
authorizations or offers to pay. Refer to Sec. 152.93.
    (4) Citation of a public literature study. Refer to Sec. 152.94.
    (5) Citation of all pertinent studies previously submitted to the 
Agency, with any necessary written authorizations or offers to pay. 
Refer to Sec. 152.95.
    (6) Documentation of a data gap. Refer to Sec. 152.96.



Sec. 152.91  Waiver of a data requirement.

    The applicant may demonstrate compliance for a data requirement by 
documenting the existence of a waiver in accordance with paragraph (a) 
of this section, or by being granted a new waiver requested in 
accordance with paragraph (b) of this section.
    (a) Request for extension of an existing waiver. An applicant may 
claim that a waiver previously granted by the Agency also applies to a 
data requirement for his product. To document this claim, the applicant 
must provide a reference to the Agency record that describes the 
previously granted waiver, such as an Agency list of waivers or an 
applicable Registration Standard, and must explain why that waiver 
should apply to his product.
    (b) Request for a new waiver. An applicant who requests a waiver to 
satisfy a data requirement must submit the information specified in 40 
CFR 158.45.
    (c) Effect of denial of waiver request. If the request for a new 
waiver or extension of an existing waiver is denied by the Agency, the 
applicant must choose another method of satisfying the data requirement.



Sec. 152.92  Submission of a new valid study.

    An applicant may demonstrate compliance for a data requirement by 
submitting a valid study that has not previously been submitted to the 
Agency. A study previously submitted to the Agency should not be 
resubmitted but should be cited in accordance with Sec. 152.93.



Sec. 152.93  Citation of a previously submitted valid study.

    An applicant may demonstrate compliance for a data requirement by 
citing a valid study previously submitted to the Agency. The study is 
not to be submitted to the Agency with the application.
    (a) Study originally submitted by the applicant. If the applicant 
certifies that he is the original data submitter, no documentation other 
than the citation is necessary.
    (b) Study previously submitted by another person. If the applicant 
is not the original data submitter, the applicant may cite the study 
only in accordance with paragraphs (b) (1) through (3) of this section.

[[Page 19]]

    (1) Citation with authorization of original data submitter. The 
applicant may cite any valid study for which he has obtained the written 
authorization of the original data submitter. The applicant must obtain 
written authorization to cite any study that is an exclusive use study. 
The applicant must certify that he has obtained from the original data 
submitter a written authorization that contains at least the following 
information:
    (i) Identification of the applicant to whom the authorization is 
granted;
    (ii) Identification by title, EPA Accession Number or Master Record 
Identification Number, and date of submission, of the study or studies 
for which the authorization is granted;
    (iii) Authorization to the applicant to use the specified study in 
satisfaction of the data requirement for the application in question; 
and
    (iv) The signature and title of the original data submitter or his 
authorized representative, and date of the authorization.
    (2) Citation with offer to pay compensation to the original data 
submitter. The applicant may cite any valid study that is not subject to 
the exclusive use provisions of FIFRA section 3(c)(1)(D)(i) without 
written authorization from the original data submitter if the applicant 
certifies to the Agency that he has furnished to the original data 
submitter:
    (i) A notification of the applicant's intent to apply for 
registration, including the proposed product name and a list of the 
product's active ingredients;
    (ii) Identification of the specific data requirement involved and of 
the study for which the offer to pay is made (by title, EPA Accession 
Number or Master Record Identification Number, and date of submission, 
if possible);
    (iii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(D);
    (iv) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for the use of the study; and
    (v) The applicant's name, address and telephone number.
    (3) Citation without authorization or offer to pay. The applicant 
may cite any valid study without written authorization from, or offer to 
pay to, the original data submitter, if:
    (i) The study was originally submitted to the Agency on or before 
December 31, 1969; or
    (ii) The study was originally submitted to the Agency on or before 
the date that is 15 years before the date of the application for which 
it is cited, and the study is not an exclusive use study, as defined in 
Sec. 152.83(c).



Sec. 152.94  Citation of a public literature study or study generated at government expense.

    (a) An applicant may demonstrate compliance for a data requirement 
by citing, and submitting to the Agency, one of the following:
    (1) A valid study from the public literature.
    (2) A valid study generated by, or at the expense of, any government 
(Federal, State, or local) agency.
    (b) In no circumstances does submission of a public literature study 
or government-generated study confer any rights on the data submitter to 
exclusive use of data or compensation under FIFRA section 3(c)(1)(D).



Sec. 152.95  Citation of all studies in the Agency's files pertinent to a specific data requirement.

    An applicant normally may demonstrate compliance for a data 
requirement by citation of all studies in the Agency's files pertinent 
of that data requirement. The applicant who selects this cite-all option 
must submit to the Agency:
    (a) A general offer to pay statement having the same wording as that 
specified in Sec. 152.86(c) except that the offer to pay may be limited 
to apply only to data pertinent to the specific data requirement(s) for 
which the cite-all method of support has been selected;
    (b) A certification that:
    (1) For each person who is included on the Data Submitters List as 
an original data submitter of exclusive use data for the active 
ingredient in question, the applicant has obtained a written 
authorization containing the information required by Sec. 152.86(a) for 
the use the any exclusive use study that would be pertinent to the 
applicant's product; and

[[Page 20]]

    (2) For each person included on the current Data Submitters List as 
an original data submitter of data that are not exclusive use for the 
active ingredient in question, the applicant has furnished:
    (i) A notification of the applicant's intent to apply for 
registration, including the name of the proposed product, and a list of 
the product's active ingredients;
    (ii) Identification of the specific data requirement(s) for which 
the offer to pay for data is being made;
    (iii) An offer to pay the person compensation to the extent required 
by FIFRA section 3(c)(1)(D);
    (iv) An offer to commence negotiations to determine the amount and 
terms of compensation, if any, to be paid for use of any study; and
    (v) The applicant's name, address and telephone number; and
    (c) An acknowledgment having the same wording as that specified in 
Sec. 152.86(d), except that it may be limited to apply only to data 
pertinent to the specific data requirement(s) for which the cite-all 
method of support has been selected.



Sec. 152.96  Documentation of a data gap.

    Except as provided in paragraph (a) of this section, an applicant 
may defer his obligation to satisfy an applicable data requirement until 
the Agency requests the data if he can demonstrate, by the procedure in 
this section, that no other person has previously submitted to the 
Agency a study that would satisfy the data requirement in question.
    (a) When data gap procedures may not be used. (1) An applicant for 
registration of a product containing a new chemical may not defer his 
obligation by the procedure in this section, unless he can demonstrate 
to the Agency's satisfaction that the data requirement was imposed so 
recently that insufficient time has elapsed for the study to have been 
completed and that, in the public interest, the product should be 
registered during the limited period of time required to complete the 
study. Refer to FIFRA section 3(c)(7)(C).
    (2) An applicant for registration of a product under FIFRA section 
3(c)(7) (A) or (B) may not defer his obligation by the procedure in this 
section if the Agency requires the data to determine:
    (i) Whether the product is identical or substantially similar to 
another currently registered product or differs only in ways that would 
not substantially increase the risk of unreasonable adverse effects on 
the environment;
    (ii) If efficacy data are required, whether the product is 
efficacious; or
    (iii) Whether the new use would substantially increase the risk of 
unreasonable adverse effects on the environment, usually required when 
the application involves a new use of a product which is identical or 
substantially similar to a currently registered product.
    (b) Data gap listed in a Registration Standard. The applicant may 
rely on a data gap that is documented by a Registration Standard without 
submitting the certification required by paragraph (c) of this section. 
If the data gap listed in the Registration Standard has been filled 
since the issuance of the Standard, the Agency will notify the applicant 
and require him to choose another method of demonstrating compliance.
    (c) Certification of a data gap. Except as provided by paragraph (b) 
of this section, an applicant who wishes to claim that a data gap exists 
must certify to the Agency that:
    (1) The applicant has furnished, by certified mail, to each original 
data submitter on the current Data Submitters List for the active 
ingredient in question, a notice containing the following information:
    (i) The name and address of the applicant;
    (ii) The name of the product, and a statement that the applicant 
intends to apply for registration of that product;
    (iii) The name(s) of the active ingredient(s) in the procuct;
    (iv) A list of the data requirements for which the applicant intends 
to claim under this section that a data gap exists; and
    (v) A request that the data submitter identify, within 60 days of 
receipt of the notice, any valid study which he has submitted to the 
Agency that would fulfill any of the data requirement(s) listed.

[[Page 21]]

    (2) The applicant has, within that 60-day period, received no 
response, or has received a negative response, from each person 
notified; and
    (3) The applicant has no basis to believe that any data have been 
submitted to the Agency that would fulfill the data requirement, and is 
entitled to claim that a data gap exists.
    (d) Requirement to obtain permission or make offer to pay. In 
responding to a data gap letter, the original data submitter is not 
deemed to have given his authorization for the applicant to cite any 
study which the data submitter identifies in his response. The applicant 
must seek and obtain specific written authorization from, or make an 
offer to pay to, the original data submitter to cite the identified 
study in order to demonstrate compliance for the data requirement. 
Nothing, however, precludes the applicant from requesting written 
authorization or making an offer to pay at the same time that he 
requests confirmation of a data gap.



Sec. 152.97  Rights and obligations of data submitters.

    (a) Right to be listed on Data Submitters List. (1) Each original 
data submitter shall have the right to be included on the Agency's Data 
Submitters List.
    (2) Each original data submitter who wishes to have his name added 
to the current Data Submitters List must submit to the Agency the 
following information:
    (i) Name and current address;
    (ii) Chemical name and common name (if any) of the active 
ingredient(s), with respect to which he is an original data submitter;
    (iii) For each such active ingredient, the type(s) of study he has 
previously submitted (corresponding to Guidelines reference numbers 
given in tables in 40 CFR part 158, if applicable), the date of 
submission, and the EPA registration number, file symbol, or other 
identifying reference for which it was submitted.
    (3) Each applicant not already included on the Data Submitters List 
for a particular active ingredient must inform the Agency at the time of 
submission of a relevant study whether he wishes to be included on the 
Data Submitters List for that pesticide.
    (b) Obligation to respond to data gap letters. An applicant who 
chooses to defer his obligation by demonstrating the existence of a data 
gap must write to each original data submitter for confirmation that the 
data submitter has not submitted a valid study that would satisfy the 
requirement. The original data submitter is not required to respond to 
such letters. However, if he fails to respond, the applicant is entitled 
to assume (and the Agency will act on the assumption) that the original 
data submitter has not submitted a study to satisfy the requirement. The 
data submitter may thereby limit his right to later challenge the 
applicant's claim if he fails respond in writing delivered to the 
applicant within 60 days of receipt of the applicant's data gap letter.



Sec. 152.98  Procedures for transfer of exclusive use or compensation rights to another person.

    A person who possesses rights to exclusive use or compensation under 
FIFRA section 3(c)(1)(D) may transfer such rights to another person in 
accordance with this section.
    (a) The original data submitter must submit to the Agency a transfer 
document that contains the following information:
    (1) The name, address and state of incorporation (if any) of the 
original data submitter (the transferor);
    (2) The name, address and state of incorporation (if any) of the 
person to whom the data rights are being transferred (the transferee);
    (3) Identification of each item of data transferred including:
    (i) The name of the study or item of data;
    (ii) Whether the study is an exclusive use study, and, if so, when 
the period of exclusive use protection expires;
    (iii) The name of the person or laboratory that conducted the study;
    (iv) The date the study was submitted to the Agency;
    (v) The EPA document number assigned to the item of data (the Master 
Record Identification Number or Accession Number), if known. If not

[[Page 22]]

known, the EPA administrative number (such as the EPA Registration 
Number, petition number, file symbol, or permit number) with which the 
item of data was submitted, such that the Agency can identify the item 
of data.
    (vi) A statement that the transferor transfers irrevocably to the 
transferee all rights, titles, and interest in the items of data named;
    (vii) A statement that the transferor and transferee understand that 
any false statement may be punishable under 18 U.S.C. 1001; and
    (viii) The names, signatures and titles of the transferor and 
transferee, and the date signed.
    (b) In addition, the original data submitter must submit to the 
Agency a notarized statement affirming that:
    (1) The person signing the transfer agreement is authorized by the 
original data submitter to bind the data submitter;
    (2) No court order prohibits the transfer, and any required court 
approvals have been obtained; and
    (3) The transfer is authorized under Federal, State, and local law 
and relevant corporate charters, bylaws or partnership agreements.
    (c) The Agency will acknowledge the transfer of the data by 
notifying both transferor and transferee, and will state the effective 
date of the transfer. Thereafter the transferee will be considered to be 
the original data submitter of the items of data transferred for all 
purposes under FIFRA section 3(c)(1)(D), unless a new transfer agreement 
is submitted to the Agency.



Sec. 152.99  Petitions to cancel registration.

    An original data submitter may petition the Agency to deny or cancel 
the registration of a product in accordance with this section if he has 
submitted to the Agency a valid study which, he claims, satisfies a data 
requirement that an applicant purportedly has failed to satisfy.
    (a) Grounds for petition. (1) If an applicant has offered to pay 
compensation to an original data submitter of a study (either 
specifically or by filing a general offer to pay statement), the 
original data submitter may petition the Agency to deny or cancel the 
registration to which the offer related on any of the following grounds:
    (i) The applicant has failed to participate in an agreed-upon 
procedure for reaching an agreement on the amount and terms of 
compensation. The petitioner shall submit a copy of the agreed-upon 
procedure and describe the applicant's failure to participate in the 
procedure.
    (ii) The applicant has failed to comply with the terms of an 
agreement on compensation. The petitioner shall submit a copy of the 
agreement, and shall describe how the applicant has failed to comply 
with the agreement.
    (iii) The applicant has failed to participate in an arbitration 
proceeding. The petitioner shall submit evidence of such failure.
    (iv) The applicant has failed to comply with the terms of an 
arbitration decision. The petitioner shall submit a copy of the 
arbitration decision, and describe how the applicant has failed to 
comply with the decision.
    (2) When no offer to pay has been made, the petitioner shall state 
in his petition the basis for the challenge, and describe how the 
failure of the applicant to comply with the procedures of this subpart 
has deprived him of the rights accorded him under FIFRA section 
3(c)(1)(D). Possible grounds for challenge include, but are not limited 
to, the following:
    (i) The applicant has failed to list a data requirement applicable 
to his product, or has failed to demonstrate compliance with all 
applicable data requirements.
    (ii) The applicant has submitted or cited a study that is not valid.
    (iii) The applicant has submitted or cited a study that does not 
satisfy the data requirement for which it was submitted or cited.
    (iv) The applicant has failed to comply with the procedure for 
showing that a data gap exists.
    (v) The applicant has improperly certified that a data gap exists. 
An original data submitter who has failed without good cause to respond 
to an applicant's request for confirmation of a data gap may not 
petition the Agency for review on this basis.
    (vi) The applicant has submitted or cited a study originally 
submitted by

[[Page 23]]

the petitioner, without the required authorization or offer to pay.
    (b) Procedure for petition to the Agency--(1) Time for filing. A 
petition under paragraph (a)(1) of this section may be filed at any time 
that the circumstances warrant. A petition under paragraph (a)(2) of 
this section must be filed within one year after the Agency makes public 
the issuance of the registration.
    (2) Notice to affected registrant. At the same time that the 
petitioner files his petition with the Agency, he shall send a copy by 
certified mail to the affected applicant or registrant. The applicant or 
registrant shall have 60 days from the date of his receipt of the 
petition to submit written comments to the Agency.
    (c) Disposition of petitions. The Agency will consider the material 
submitted by the petitioner and the response, if any, by the affected 
applicant or registrant.
    (1) If the Agency determines that the petition is without merit, it 
will inform the petitioner and the affected applicant or registrant that 
the petition is denied. Denial of a petition is a final Agency action.
    (2) If the Agency determines that an applicant has acted in any way 
described by paragraph (a)(1) of this section, the Agency will notify 
the petitioner and the affected applicant or registrant that it intends 
to deny or cancel the registration of the product in support of which 
the data were cited. The affected applicant or registrant will have 15 
days from the date of delivery of this notice to respond. If the Agency 
determines, after considering any response, that the affected applicant 
or registrant has acted in the ways described by paragraph (a)(1) of 
this section, the Agency will deny or cancel the registration without 
further hearing. Refer to FIFRA section 3(c)(1)(D)(ii). Denial or 
cancellation of a registration is a final Agency action.
    (3) Except as provided in paragraph (c)(2) of this section, if the 
Agency determines that an applicant for registration of a product has 
acted in any way that deprives an original data submitter of rights 
under FIFRA section 3(c)(1)(D), the Agency will take steps to deny the 
application or cancel the registration, as appropriate. The procedures 
in FIFRA section 3(c)(6) or section 6(b) shall be followed. Denial or 
cancellation is a final Agency action.
    (d) Hearing. Any hearing will be conducted in accordance with the 
procedures in 40 CFR part 164. The only matter for resolution at the 
hearing shall be whether the registrant failed to comply with the 
requirements and procedures of FIFRA section 3(c)(1)(D) or of this 
subpart, in the manner described by the petitioner. A decision following 
a hearing shall be final.



                Subpart F--Agency Review of Applications

    Source: 53 FR 15980, May 4, 1988, unless otherwise noted.



Sec. 152.100  Scope.

    (a) The Agency will follow the procedures in this subpart for all 
applications for registration, except an application for registration of 
a pesticide that has been the subject of a previous Agency cancellation 
or suspension notice under FIFRA sec. 6.
    (b) The Agency will follow the procedures of subpart D of part 164 
of this chapter in evaluating any application for registration of a 
pesticide involving use of the pesticide in a manner that is prohibited 
by a suspension or cancellation order, to the extent required by subpart 
D of part 164.



Sec. 152.102  Publication.

    The Agency will issue in the Federal Register a notice of receipt of 
each application for registration of a product that contains a new 
active ingredient or that proposes a new use. After registration of the 
product, the Agency will issue in the Federal Register a notice of 
issuance. The notice of issuance will describe the new chemical or new 
use, summarize the Agency's regulatory conclusions, list missing data 
and the conditions for their submission, and respond to comments 
received on the notice of application.



Sec. 152.104  Completeness of applications.

    The applicant is responsible for the accuracy and completeness of 
all information submitted in connection with

[[Page 24]]

the application. The Agency will review each application to determine 
whether it is complete. An application is incomplete if any pertinent 
item specified in Sec. 152.50 has not been submitted, or has been 
incorrectly submitted (for example, data required by part 158 of this 
chapter not submitted in accordance with the requirements for format, 
claims of confidential business information, or flagging).



Sec. 152.105  Incomplete applications.

    The Agency will not begin or continue the review of an application 
that is incomplete. If the Agency determines that an application is 
incomplete or that further information is needed in order to complete 
the Agency's review, the Agency will notify the applicant of the 
deficiencies and allow the applicant 75 days to make corrections or 
additions to complete the application. If the applicant believes that 
the deficiencies cannot be corrected within 75 days, he must notify the 
Agency within those 75 days of the date on which he expects to complete 
the application. If, after 75 days, the applicant has not responded, or 
if the applicant subsequently fails to complete the application within 
the time scheduled for completion, the Agency will terminate any action 
on such application, and will treat the application as if it had been 
withdrawn by the applicant. Any subsequent submission relating to the 
same product must be submitted as a new application.



Sec. 152.107  Review of data.

    (a) The Agency normally will review data submitted with an 
application that have not previously been submitted to the Agency.
    (b) The Agency normally will review other data submitted or cited by 
an applicant only:
    (1) As part of the process of reregistering currently registered 
products;
    (2) When acting on an application for registration of a product 
containing a new active ingredient;
    (3) If such data have been flagged in accordance with Sec. 158.34 of 
this chapter; or
    (4) When the Agency determines that it would otherwise serve the 
public interest.
    (c) If the Agency finds that it needs additional data in order to 
determine whether the product may be registered, it will notify the 
applicant as early as possible in the review process.



Sec. 152.108  Review of labeling.

    The Agency will review all draft labeling submitted with the 
application. If an applicant for amended registration submits only that 
portion of the labeling proposed for amendment, the Agency may review 
the entire label, as revised by the proposed changes, in deciding 
whether to approve the amendment. The Agency will not approve final 
printed labeling, but will selectively review it for compliance.



Sec. 152.110  Time for Agency review.

    The Agency will complete its review of applications as expeditiously 
as possible. Applications involving new active ingredients, new uses, 
petitions for tolerance or exemptions, or consultation with other 
Federal agencies normally will take longer than applications for 
substantially similar products and uses.



Sec. 152.111  Choice of standards for review of applications.

    The Agency has discretion to review applications under either the 
unconditional registration criteria of FIFRA sec. 3(c)(5) or the 
conditional registration criteria of FIFRA sec. 3(c)(7). The type of 
review chosen depends primarily on the extent to which the relevant data 
base has been reviewed for completeness and scientific validity. EPA 
conducts data reviews needed to support unconditional registrations on a 
chemical-by-chemical basis, according to an established priority list. 
Except for applications for registration of a new active ingredient or 
in special cases where it finds immediate review to be warranted, the 
Agency will not commence a complete review of the existing data base on 
a given chemical in response to receipt of an application for 
registration. Instead the Agency will review the application using the 
criteria for conditional registration in FIFRA sec. 3(c)(7) (A) and (B).

[[Page 25]]



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 Secs. 152.107 and 152.111);
    (c) The Agency has determined that no additional data are necessary 
to make the determinations required by FIFRA sec. 3(c)(5) with respect 
to the pesticide product which is the subject of the application;
    (d) The Agency has determined that the composition of the product is 
such as to warrant the proposed efficacy claims for it, if efficacy data 
are required to be submitted by part 158 of this chapter for the 
product;
    (e) The Agency has determined that the product will perform its 
intended function without unreasonable adverse effects on the 
environment, and that, when used in accordance with widespread and 
commonly recognized practice, the product will not generally cause 
unreasonable adverse effects on the environment;
    (f) The Agency has determined that the product is not misbranded as 
that term is defined in FIFRA sec. 2(q) and part 156 of this chapter, 
and its labeling and packaging comply with the applicable requirements 
of the Act, this part, and parts 156 and 157 of this chapter;
    (g) If the proposed labeling bears directions for use on food, 
animal feed, or food or feed crops, or if the intended use of the 
pesticide results or may reasonably be expected to result, directly or 
indirectly, in pesticide residues (including residues of any active or 
inert ingredient of the product, or of any metabolite or degradation 
product thereof) in or on food or animal feed, all necessary tolerances, 
exemptions from the requirement of a tolerance, and food additive 
regulations have been issued under FFDCA sec. 408, sec. 409 or both; and
    (h) If the product, in addition to being a pesticide, is a drug 
within the meaning of FFDCA sec. 201(q), the Agency has been notified by 
the Food and Drug Administration (FDA) that the product complies with 
any requirements imposed by FDA.



Sec. 152.113  Approval of registration under FIFRA sec. 3(c)(7)--Products that do not contain a new active ingredient.

    (a) Except as provided in paragraph (b) of this section, the Agency 
may approve an application for registration or amended registration of a 
pesticide product, each of whose active ingredients is contained in one 
or more other registered peticide products, only if the Agency has 
determined that:
    (1) It possesses all data necessary to make the determinations 
required by FIFRA sec. 3(c)(7)(A) or (B) with respect to the pesticide 
product which is the subject of the application (including, at a 
minimum, data needed to characterize any incremental risk that would 
result from approval of the application);
    (2) Approval of the application would not significantly increase the 
risk of any unreasonable adverse effect on the environment; and
    (3) The criteria of Sec. 152.112(a), (d), and (f) through (h) have 
been satisfied.
    (b) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide under FIFRA sec. 3(c)(7)(A) unless the Agency has determined 
that the applicant's product and its proposed use are identical or 
substantially similar to a currently registered pesticide and use, or 
that the pesticide and its proposed use differ only in ways that would 
not significantly increase the risk of unreasonable adverse effects on 
the environment.
    (c) Notwithstanding the provisions of paragraph (a) of this section, 
the Agency will not approve the conditional registration of any 
pesticide product for a new use under FIFRA sec. 3(c)(7)(B) if:
    (1) The pesticide is the subject of a special review, based on a use 
of the product that results in human dietary exposure; and

[[Page 26]]

    (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.
    (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]

[[Page 27]]



Sec. 152.116  Notice of intent to register to original submitters of exclusive use data.

    (a) Except as provided in paragraph (c) of this section, at least 30 
days before registration of a product containing an active ingredient 
for which a previously submitted study is eligible for exclusive use 
under FIFRA sec. 3(c)(1)(D)(i), the Agency will notify the original 
submitter of the exclusive use study of the intended registration of the 
product. If requested by the exclusive use data submitter within 30 
days, the Agency will also provide the applicant's list of data 
requirements and method of demonstrating compliance with each data 
requirement.
    (b) Within 30 days after receipt of the Agency's notice, or of the 
applicant's list of data requirements, whichever is later, the exclusive 
use data submitter may challenge the issuance of the registration in 
accordance with the procedures in Sec. 152.99 (b) and (c). If the Agency 
finds that the challenge has merit, it will issue a notice of denial of 
the application. The applicant may then avail himself of the hearing 
procedures provided by FIFRA sec. 3(c)(6). If the Agency finds that the 
challenge is without merit, it will deny the petition and register the 
applicant's product. Denial of the petition is a final Agency action.
    (c) If an applicant has submitted to the Agency a certification from 
an exclusive use data submitter that he is aware of the applicant's 
application for registration, and does not object to the issuance of the 
registration, the Agency will not provide the 30-day notification 
described in paragraph (a) of this section to that exclusive use data 
submitter.



Sec. 152.117  Notification to applicant.

    The Agency will notify the applicant of the approval of his 
application by a Notice of Registration for new registration, or by a 
letter in the case of an amended registration.



Sec. 152.118  Denial of application.

    (a) Basis for denial. The Agency may deny an application for 
registration if the Agency determines that the pesticide product does 
not meet the criteria for registration under either FIFRA sec. 3(c)(5) 
or (7), as specified in Secs. 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.
    (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.

[[Page 28]]



            Subpart G--Obligations and Rights of Registrants

    Source: 53 FR 15983, May 4, 1988, unless otherwise noted.



Sec. 152.122  Currency of address of record and authorized agent.

    (a) The registrant must keep the Agency informed of his current name 
and address of record. If the Agency's good faith attempts to contact 
the registrant are not successful, the Agency will issue in the Federal 
Register a notice of intent to cancel all products of the registrant 
under FIFRA sec. 6(b). The registrant must respond within 30 days 
requesting that the registrations be maintained in effect, and providing 
his name and address of record. If no response is received, the 
cancellations will become effective at the end of 30 days without 
further notice to the registrant. The Agency may make provision for the 
sale and distribution of existing stocks of such products after the 
effective date of cancellation.
    (b) The registrant must also notify the Agency if he changes his 
authorized agent.



Sec. 152.125  Submission of information pertaining to adverse effects.

    If at any time the registrant receives or becomes aware of any 
factual information regarding unreasonable adverse effects of the 
pesticide on the environment that has not previously been submitted to 
the Agency, he shall, in accordance with FIFRA sec. 6(a)(2), provide 
such information to the Agency, clearly identified as FIFRA 6(a)(2) 
data.

[53 FR 15975, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



Sec. 152.130  Distribution under approved labeling.

    (a) A registrant may distribute or sell a registered product with 
the composition, packaging and labeling currently approved by the 
Agency.
    (b) A registrant may distribute or sell a product under labeling 
bearing any subset of the approved directions for use, provided that in 
limiting the uses listed on the label, no changes would be necessary in 
precautionary statements, use classification, or packaging of the 
product.
    (c) Normally, if the product labeling is amended on the initiative 
of the registrant, by submission of an application for amended 
registration, the registrant may distribute or sell under the previously 
approved labeling for a period of 18 months after approval of the 
revision, unless an order subsequently issued by the Agency under FIFRA 
sec. 6 or 13 provides otherwise. However, if paragraph (d) of this 
section applies to the registrant's product, the time frames established 
by the Agency in accordance with that paragraph shall take precedence.
    (d) If a product's labeling is required to be revised as a result of 
the issuance of a Registration Standard, a Label Improvement Program 
notice, or a notice concluding a special review process, the Agency will 
specify in the notice to the registrant the period of time that 
previously approved labeling may be used. In all cases, supplemental or 
sticker labeling may be used as an interim compliance measure for a 
reasonable period of time. The Agency may establish dates as follows 
governing when label changes must appear on labels:
    (1) The Agency may establish a date after which all product 
distributed or sold by the registrant must bear revised labeling.
    (2) The Agency may also establish a date after which no product may 
be distributed or sold by any person unless it bears revised labeling. 
This date will provide sufficient time for product in channels of trade 
to be distributed or sold to users or otherwise disposed of.



Sec. 152.132  Supplemental distribution.

    The registrant may distribute or sell his registered product under 
another person's name and address instead of (or in addition to) his 
own. Such distribution and sale is termed ``supplemental distribution'' 
and the product is referred to as a ``distributor product.'' The 
distributor is considered an agent of the registrant for all intents and 
purposes under the Act, and both the registrant and the distributor may 
be held liable for violations pertaining

[[Page 29]]

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;
    (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;

[[Page 30]]

    (2) No court order prohibits the transfer, and that any required 
court approvals have been obtained; and
    (3) The transfer is authorized under all relevant Federal, State and 
local laws and all relevant corporate charters, bylaws, partnerships, or 
other agreements.
    (d) If the required documents are submitted, and no information 
available to the Agency indicates that the information is incorrect, the 
Agency will approve the transfer without requiring that the transferee 
obtain a new registration. The Agency will notify the transferor and 
transferee of its approval.
    (e) The transfer will be effective on the date of Agency approval. 
Thereafter the transferee will be regarded as the registrant for all 
purposes under FIFRA.
    (f) Rights to exclusive use of data or compensation under FIFRA sec. 
3(c)(1)(D) are separate from the registration itself and may be retained 
by the transferor, or may be transferred independently in accordance 
with the provisions of Sec. 152.98. If the registrant as the original 
data submitter wishes to transfer data rights at the same time as he 
transfers the registration, he may submit a single transfer document 
containing the information required by this section for both the 
registration and the data.

[53 FR 15983, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]

Subpart H [Reserved]



                 Subpart I--Classification of Pesticides

    Source: 53 FR 15986, May 4, 1988, unless otherwise noted.



Sec. 152.160  Scope.

    (a) Types of classification. A pesticide product may be 
unclassified, or it may be classified for restricted use or for general 
use. The Agency does not normally classify products for general use; 
products that are not restricted remain unclassified.
    (b) Kinds of restrictions. The Agency may restrict a product or its 
uses to use by a certified applicator, or by or under the direct 
supervision of a certified applicator, as described in FIFRA sec. 
3(d)(1)(C). The Agency may also, by regulation, prescribe restrictions 
relating to the product's composition, labeling, packaging, uses, or 
distribution and sale, or to the status or qualifications of the user.



Sec. 152.161  Definitions.

    In addition to the definitions in Sec. 152.3, the following terms 
are defined for the purposes of this subpart:
    (a) Dietary LC50 means a statistically derived estimate 
of the concentration of a test substance in the diet that would cause 50 
percent mortality to the test population under specified conditions.
    (b) Outdoor use means any pesticide application that occurs outside 
enclosed manmade structures or the consequences of which extend beyond 
enclosed manmade structures, including, but not limited to, pulp and 
paper mill water treatments and industrial cooling water treatments.



Sec. 152.164  Classification procedures.

    (a) Grouping of products for classification purposes. In its 
discretion, the Agency may identify a group of products having common 
characteristics or uses and may classify for restricted use same or all 
of the products or uses included in that group. Such a group may be 
comprised of, but is not limited to, products that:
    (1) Contain the same active ingredients.
    (2) Contain the same active ingredients in a particular 
concentration range, formulation type, or combination of concentration 
range and formulation type.
    (3) Have uses in common.
    (4) Have other characteristics, such as toxicity, flammability, or 
physical properties, in common.
    (b) Classification reviews. The Agency may conduct classification 
reviews and classify products at any time, if it determines that a 
restriction on the use of a pesticide product is necessary to avoid 
unreasonable adverse effects on the environment. However, classification 
reviews normally will be conducted and products classified only in the 
following circumstances:

[[Page 31]]

    (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.
    (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

[[Page 32]]

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:
    (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

[[Page 33]]

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
    (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:

[[Page 34]]

    (i) The user, in order to follow label directions, would not be 
required to perform complex operations or procedures requiring 
specialized training and/or experience.
    (ii) The label directions do not call for specialized apparatus, 
protective equipment, or materials that reasonably would not be 
available to the general public.
    (iii) Failure to follow label directions in a minor way would result 
in few or no significant adverse effects.
    (iv) Following directions for use would result in few or no 
significant adverse effects of a delayed or indirect nature through 
bioaccumulation, persistence, or pesticide movement from the original 
application site.
    (v) Widespread and commonly recognized practices of use would not 
nullify or detract from label directions such that unreasonable adverse 
effects on the environment might occur.



Sec. 152.171  Restrictions other than those relating to use by certified applicators.

    The Agency may by regulation impose restrictions on a product or 
class of products if it determines that:
    (a) Without such restrictions, the product when used in accordance 
with warnings, cautions and directions for use or in accordance with 
widespread and commonly recognized practices of use may cause 
unreasonable adverse effects on the environment; and
    (b) The decrease in risks as a result of restricted use would exceed 
the decrease in benefits as a result of restricted use.



Sec. 152.175  Pesticides classified for restricted use.

    The following uses of pesticide products containing the active 
ingredients specified below have been classified for restricted use and 
are limited to use by or under the direct supervision of a certified 
applicator.

[[Page 35]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                Criteria influencing
          Active ingredient                     Formulation                 Use pattern            Classification \1\               restriction
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acrolein............................  As sole active ingredient. No   All uses...............  Restricted................  Inhalation hazard to humans.
                                       mixtures registered.                                                                 Residue effects on avian
                                                                                                                            species and aquatic
                                                                                                                            organisms.
Aldicarb............................  As sole active ingredient.....  Ornamental uses (indoor  ......do..................  Other hazards--accident
                                                                       and outdoor).                                        history.
                                      No mixtures registered........  Agricultural crop uses.  Under further evaluation..
Aluminum phosphide..................  As sole active ingredient. No   ......do...............  ......do..................  Inhalation hazard to humans.
                                       mixtures registered.
Azinphos methyl.....................  All liquids with a              ......do...............  ......do..................      Do.
                                       concentration greater than
                                       13.5 pct.
                                      All other formulations........  ......do...............  Under futher evaluation...
Carbofuran..........................  All concentrate suspensions     ......do...............  ......do..................  Acute inhalation toxicity.
                                       and wettable powders 40% and
                                       greater.
                                      All granular formulations.....  Rice...................  Under evaluation..........
                                      All granular and fertilizer     All uses except rice...  ......do..................
                                       formulations.
Chloropicrin........................  All formulations greater than   All uses...............  ......do..................  Acute inhalation toxicity.
                                       2%.
                                      All formulations..............  Rodent control.........  ......do..................  Hazard to non-target
                                                                                                                            organisms.
                                      All formulations 2% and less..  Outdoor uses (other      Unclassified..............
                                                                       than rodent control).
Clonitralid.........................  All wettable powders 70% and    All uses...............  Restricted................  Acute inhalation toxicity.
                                       greater.
                                      All granulars and wettable      Molluscide uses........  Restricted................  Effects on aquatic organisms.
                                       powders.
                                      Pressurized sprays 0.55% and    Hospital antiseptics...  Unclassified..............
                                       less.
Dicrotophos.........................  All liquid formulations 8% and  All uses...............  Restricted................  Acute dermal toxicity;
                                       greater.                                                                             residue effects on avian
                                                                                                                            species (except for tree
                                                                                                                            injections).
Disulfoton..........................  All emulsifiable concentrates   ......do...............  Restricted................      Do.
                                       65% and greater, all                                                                Acute inhalation 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 95% and    Commercial seed          Restricted................  Acute dermal toxicity.
                                       greater.                        treatment.
                                      Granular formulations 10% and   Indoor uses              ......do..................  Acute inhalation toxicity.
                                       greater.                        (greenhouse).
Ethoprop............................  Emulsifiable concentrates 40%   Aquatic uses...........  ......do..................  Acute dermal toxicity.
                                       and greater.
                                      All granular and fertilizer     All uses...............  Under evaluation..........
                                       formulations.
Ethyl parathion.....................  All granular and dust           ......do...............  Restricted................  Inhalation hazard to humans.
                                       formulations greater than 2                                                          Acute dermal toxicity.
                                       pct, fertilizer formulations,                                                        Residue effects on
                                       wettable powders,                                                                    mammalian, aquatic, avian
                                       emulsifiable concentrates,                                                           species.
                                       concentrated suspensions,
                                       concentrated solutions.
                                      Smoke fumigants...............  ......do...............  ......do..................  Inhalation hazard to humans.
                                      Dust and granular formulations  ......do...............  ......do..................  Other hazards--accident
                                       2 pct and below.                                                                     history.
Fenamiphos..........................  Emulsifiable concentrates 35%   ......do...............  ......do..................  Acute dermal toxicity.
                                       and greater.
Fonofos.............................  Emulsifiable concentrates 44%   ......do...............  ......do..................  Acute dermal toxicity.
                                       and greater.
                                      Emulsifiable concentrates       Tobacco................  Unclassified..............
                                       12.6% and less with pebulate
                                       50.3% and less.
Methamidophos.......................  Liquid formulations 40% and     ......do...............  Restricted................  Acute dermal toxicity;
                                       greater.                                                                             residue effects on avian
                                                                                                                            species.
                                      Dust formulations 2.5% and      ......do...............  ......do..................  Residue effects on avian
                                       greater.                                                                             species.

[[Page 36]]

 
Methidathion........................  All formulations..............  All uses except nursery  ......do..................      Do.
                                                                       stock, safflower and
                                                                       sunflower.
                                      All formulations..............  Nursery stock,           Unclassified..............
                                                                       safflower and
                                                                       sunflower.
Methomyl............................  As sole active ingredient in 1  Nondomestic outdoors-    Restricted................  Residue effects on mammalian
                                       pct to 2.5 baits (except 1      agricultural crops,                                  species.
                                       pct fly bait).                  ornamental and turf.
                                                                       All other registered
                                                                       uses.
                                      All concentrated solution       ......do...............  ......do..................  Other hazards-accident
                                       formulations.                                                                        history.
                                      90 pct wettable powder          ......do...............  ......do..................      Do.
                                       formulations (not in water
                                       soluble bags).
                                      90 pct wettable powder          ......do...............  Unclassified..............
                                       formulation in water soluble
                                       bags.
                                      All granular formulations.....  ......do...............  ......do..................
                                      25 pct wettable powder          ......do...............  ......do..................
                                       formulations.
                                      In 1.24 pct to 2.5 pct dusts    ......do...............  ......do..................
                                       as sole active ingredient and
                                       in mixtures with fungicides
                                       and chlorinated hydrocarbon,
                                       inorganic phosphate and
                                       biological insecticides.
Methyl bromide......................  All formulations in containers  All uses...............  Restricted................      Do.
                                       greater than 1.5 lb.
                                      Containers with not more than   Single applications      Unclassified..............
                                       1.5 lb of methyl bromide with   (nondomestic use) for
                                       0.25 pct to 2.0 pct             soil treatment in
                                       chloropicrin as an indicator.   closed systems.
                                      Container with not more than    All uses...............  Restricted................      Do.
                                       1.5 lb having no indicator.
Methyl parathion....................  All dust and granular           ......do...............  ......do..................  Other hazards-accident
                                       formulations less 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 toxicity.
                                       formulations 5 pct and                                                               Residue effects on mammalian
                                       greater and all wettable                                                             and avian species.
                                       powders and liquids.
Nicotine (alkaloid).................  Liquid and dry formulations     Indoor (greenhouse)....  ......do..................  Acute inhalation toxicity.
                                       14% and above.
                                      All formulations..............  Applications to          ......do..................  Effects on aquatic organisms.
                                                                       cranberries.
                                      Liquid and dry formulations     All uses (domestic and   Unclassified..............
                                       1.5% and less.                  nondomestic).
Paraquat (dichloride) and paraquat    All formulations and            All uses...............  Restricted................  Other hazards. Use and
 bis(methyl sulfate).                  concentrations except those                                                          accident history, human
                                       listed below.                                                                        toxicological data.
                                      Pressurized spray formulations  Spot weed and grass      ......do..................
                                       containing 0.44 pct Paraquat    control.
                                       bis(methyl sulfate) and 15
                                       pct petroleum distillates as
                                       active ingredients.

[[Page 37]]

 
                                      Liquid fertilizers containing   All uses...............  Unclassified..............
                                       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 65% and     ......do...............  Restricted................  Acute dermal toxicity.
                                       greater.                                                                            Residue effects on avian
                                                                                                                            species (applies to foliar
                                                                                                                            applications only).
                                                                                                                           Residue effects on mammalian
                                                                                                                            species (applies to foliar
                                                                                                                            application only).
                                      All granular formulations.....  Rice...................  ......do..................  Effects on aquatic organisms.
Phosphamidon........................  Liquid formulations 75% and     ......do...............  ......do..................  Acute dermal toxicity.
                                       greater.                                                                            Residue effects on mammalian
                                                                                                                            species.
                                                                                                                           Residue effects on avian
                                                                                                                            species.
                                      Dust formulations 1.5% and      ......do...............  ......do..................      Do.
                                       greater.                                                                            Residue effects on mammalian
                                                                                                                            species.
Picloram............................  All formulations and            ......do...............  ......do..................  Hazard to nontarget organisms
                                       concentrations except tordon                                                         (specifically nontarget
                                       101 R.                                                                               plants both crop and
                                                                                                                            noncrop).
                                      Tordon 101 R forestry           Control of unwanted      Unclassified..............
                                       herbicide containing 5.4 pct    trees by cut surface
                                       picloram and 20.9 pct 2.4-D.    treatment.
Sodium cyanide \3\..................  All capsules and ball           All uses...............  Restricted................  Inhalation hazard to humans.
                                       formulations.
Sodium fluoroacetate................  All solutions and dry baits...  ......do...............  ......do..................  Acute oral toxicity. Hazard
                                                                                                                            to nontarget organisms. Use
                                                                                                                            and accident history.
Strychnine..........................  All dry baits, pellets and      ......do...............  ......do..................  Acute oral toxicity. Hazard
                                       powder formulations greater                                                          to nontarget avain species.
                                       than 0.5 pct.                                                                        Use and accident history.
                                      All dry baits, pellets and      All uses calling for     ......do..................  Hazard to nontarget
                                       powder formulations.            burrow builders.                                     organisms.
                                      All dry baits, pellets and      All uses except subsoil  ......do..................      Do.
                                       powder formulations 0.5 pct
                                       and below.
                                      ......do......................  All subsoil uses.......  Unclassified..............
Sulfotepp...........................  Sprays and smoke generators...  All uses...............  Restricted................  Inhalation hazard to humans.
Zinc Phosphide......................  All formulations 2% and less..  All domestic uses and    Unclassified..............
                                                                       non-domestic uses in
                                                                       and around buildings.
                                      All dry formulations 60% and
                                       greater..
                                                                      All uses...............  Restricted................  Acute inhalation toxicity.
                                      All bait formulations.........  Non-domestic outdoor     ......do..................  Hazard to non-target
                                                                       uses (other than                                     organisms.
                                                                       around buildings).
                                      All dry formulations 10% and    Domestic uses..........  ......do..................  Acute oral toxicity.
                                       greater.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ ``Under evaluation'' means no classification decision has been made and the use/formulation in question is still under active review within EPA.
\2\ Percentages given are the total of dioxathion plus related compounds.
\3\ (Note-- M-44 sodium cyanide capsules may only be used by certified applicators who have also taken the required additional training.)

[43 FR 5790, Feb. 9, 1978, as amended at 44 FR 45132, Aug. 1, 1979; 46 
FR 5698, Jan. 19, 1981. Redesignated and amended at 53 FR 15988, May 4, 
1988; 60 FR 32096, June 19, 1995]

[[Page 38]]

Subparts J-T [Reserved]



                      Subpart U--Registration Fees

    Source: 53 FR 19114, May 26, 1988, unless otherwise noted.



Sec. 152.400  Purpose.

    Subpart U prescribes fees to be charged for the pesticide regulatory 
activities set forth in Sec. 152.403 as performed by the Environmental 
Protection Agency (as authorized by 31 U.S.C. 9701 and Pub. L. 100-202) 
and provisions regarding their payment.



Sec. 152.401  Inapplicability of fee provisions to applications filed prior to October 1, 1997.

    No fee required by this subpart U shall be levied with respect to 
any application filed during the period beginning on October 25, 1988, 
and ending on September 30, 1997. See FIFRA section 4(i)(7) (added to 
FIFRA by Pub. L. 100-532, October 25, 1988, 102 Stat. 2654).

[53 FR 11923, Mar. 22, 1989]



Sec. 152.403  Definitions of fee categories.

    (a) New chemical registration review means review of an application 
for registration of a pesticide product containing a chemical active 
ingredient which is not contained as an active ingredient in any other 
pesticide product that is registered under FIFRA at the time the 
application is made.
    (b) New biochemical and microbial registration review means review 
of an application for registration of a biochemical or microbial 
pesticide product containing a biochemical or microbial active 
ingredient not contained in any other pesticide product that is 
registered under FIFRA at the time the application is made. For purposes 
of this subpart, the definitions of biochemical and microbial pesticides 
contained in Sec. 158.65 (a) and (b) of this chapter shall apply.
    (c) New use pattern registration review means review of an 
application for registration, or for amendment of a registration 
entailing a major change to the use pattern of an active ingredient 
contained in a product registered under FIFRA or pending Agency decision 
on a prior application at the time of application. For purposes of this 
paragraph, examples of major changes include but are not limited to, 
changes from non-food to food use, outdoor to indoor use, ground to 
aerial application, terrestrial to aquatic use, and non-residential to 
residential use.
    (d) Old chemical registration review means review of an application 
for registration of a new product containing active ingredients and uses 
which are substantially similar or identical to those currently 
registered or for which an application is pending Agency decision.
    (e) Amendment review means review of any application requiring 
Agency approval to amend the registration of a currently registered 
product, or for which an application is pending Agency decision, not 
entailing a major change to the use pattern of an active ingredient.
    (f) Experimental use permit review means review of an application 
for a permit pursuant to section 5 of FIFRA to apply a limited quantity 
of a pesticide in order to accumulate information necessary to register 
the pesticide. The application may be for a new chemical or for a new 
use of an old chemical. The fee applies to such experimental uses of a 
single unregistered active ingredient (no limit on the number of other 
active ingredients, in a tank mix, already registered for the crops 
involved) and no more than three crops. This fee does not apply to 
experimental use permits required for small-scale field testing of 
microbial pest control agents (40 CFR 172.3).



Sec. 152.404  Fee amounts.

    The fee prescribed by the following table must be submitted with 
each application for registration, amended registration or experimental 
use permit. Fees will be adjusted annually in accordance with 
Sec. 152.410. The Agency may waive or refund fees in accordance with 
Sec. 152.412.

                        Table--Registration Fees
------------------------------------------------------------------------
                        Type of review                            Fee
------------------------------------------------------------------------
New chemical.................................................   $184,500
New biochemical or microbial.................................     64,000
New use pattern..............................................     33,800
Experimental use permit......................................      4,500
Old chemical.................................................      4,000

[[Page 39]]

 
Amendment....................................................        700
------------------------------------------------------------------------


[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.406  Submission of supplementary data.

    Applicants may submit data to supplement pending applications 
without incurring additional charges if the proper fee was paid with 
submission of the original application and subsequent submissions of 
supplementary data do not constitute a change in the type of 
registration action requested.

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.408  Special considerations.

    (a) If two or more applicants apply for a new chemical registration 
for products having the same active ingredient and each applicant 
provides a set of data in support of the registration developed 
independently of the other applicants' data, then each applicant 
submitting an independent set of data shall be charged the full new 
chemical registration review fee.
    (b) If two or more applicants apply for a new chemical registration 
for products having the same active ingredient and the applicants have 
jointly developed or paid for the joint development of a common set of 
data to support their applications for registration, then each applicant 
shall be charged an equal share of the total fee for review of the 
applications for all of the subject products. The total fee will include 
the sum of the new chemical registration review fee for one product and 
one old chemical registration review fee for each additional product.
    (c) If an application is received for registration of a product that 
contains two or more new chemical active ingredients and a different set 
of generic data is required by the Agency for each new chemical for the 
purpose of registration, the applicant will be required to pay the full 
new chemical registration review fee for each active ingredient.



Sec. 152.410  Adjustment of fees.

    (a) The fee schedule will be adjusted annually by the same 
percentage as the percent change in the Federal General Schedule (GS) 
pay scale. Such adjustments will be published in the Federal Register as 
a final rule and will be effective 30 days or more after promulgation.
    (b) Processing costs and fees will be reviewed periodically and 
changes will be made to the schedule as necessary. Such adjustments will 
be published for notice and comment in the Federal Register.



Sec. 152.412  Waivers and refunds.

    (a) Refunds. If an application is not accepted for processing 
because it is incomplete, the fee, less $1,200 for handling and initial 
review (or the amount of the fee, whichever is less), shall be returned. 
If an application is withdrawn by the applicant before significant 
Agency scientific review has begun, the fee, less $1,200, shall be 
returned. If an unacceptable or withdrawn petition is resubmitted, it 
shall be accompanied by the fee that would be required if it were 
submitted for the first time.
    (b) Waiver of fees for activities initiated by the Agency. The 
Agency may waive fees for amended registrations where the amendment has 
been initiated solely by the Agency. The Agency retains sole discretion 
in determining when this fee will be waived. The announcement of the fee 
waiver will accompany the EPA request for an amendment. The Agency will 
not approve any individual requests for waivers of EPA-initiated 
activity fees.
    (c) Waiver of fees for activities initiated by applicants. Upon 
request by an applicant, together with the supporting documentation or 
justification described in this paragraph, the Agency may waive or 
refund fees in whole or in part. A request for waiver must be submitted 
in accordance with Sec. 152.414(a). An application for which a waiver of 
fees has been requested will not be accepted for review until the waiver 
has been granted, or until the waiver has been denied and thereafter the 
proper fee has been submitted.
    (1) Minor use. Fees may be waived for applications limited to minor 
uses that

[[Page 40]]

lack commercial feasibility for the pesticide applicant. An applicant 
requesting a waiver on this basis must provide supporting information 
that demonstrates that anticipated revenues from the uses that are the 
subject of the application would be insufficient to pay back the cost of 
the fee. The burden of proof of the reasonableness of this estimate 
rests with the applicant.
    (2) IR-4. Fees will be waived for registration actions that are 
determined to be specifically associated with tolerance petitions 
submitted by the Inter-Regional Research Project Number 4 (IR-4 program) 
when such waiver is deemed by the Agency to be in the public interest.
    (3) Severe economic impact. The Agency may waive two-thirds of any 
cumulative registration fee payment in a 12-month period following 
completion of the applicant's most recent fiscal year that exceeds 3 
percent of the applicant's pesticide sales in its most recently 
completed fiscal year. An applicant requesting a waiver on this basis 
must provide documentation (e.g. copy of an annual report, or income tax 
forms filed with the Internal Revenue Service, or if needed, a notarized 
statement signed by a corporate officer regarding annual pesticide 
sales) demonstrating that:
    (i) The company applying had less than $40 million in gross revenue 
(including all revenue sources) in the most recently concluded fiscal 
year of operation, and a single fee would constitute more than 3 percent 
of the applicant's gross revenue from pesticide sales in the most 
recently completed fiscal year of operation, or
    (ii) The company applying had less than $40 million in gross revenue 
(including all revenue sources) in the most recently concluded fiscal 
year of operation, and the cumulative registration fees paid during the 
12 months following the applicant's most recently completed fiscal year, 
including any registration fees paid for the applicant for which a 
waiver is requested, constitute more than 3 percent of the applicant's 
gross revenue from pesticide sales in the most recently concluded fiscal 
year of operation.
    (iii) The Agency will not grant such a waiver if it determines that 
the entity submitting the application has been formed or manipulated to 
qualify for such a waiver.
    (4) Public interest. The Agency, in its discretion, may waive in 
whole or in part any of the fees established herein in the public 
interest. Examples include, but are not limited to, pesticides offering 
unique advantages for reducing public health risks, those that 
significantly reduce a current environmental risk, or a product with 
extraordinary utility for use in Integrated Pest Management (IPM).

[53 FR 19114, May 26, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 152.414  Procedures.

    (a) Procedures for requesting a waiver. (1) A request for a waiver 
must be submitted in writing at the time the application is submitted to 
the Environmental Protection Agency, Office of Pesticide Programs, 
Registration Division (TS-767C), 401 M. Street SW., Washington, DC 
20460.
    (2) A payment of $1,200 for processing the waiver or the amount of 
the actual fee, whichever is less, must be submitted simultaneously to 
the address set forth in paragraph (b) of this section. This fee will be 
refunded (or applied to any resulting partial fee) if the waiver is 
granted. Payment of fees for the registration activities, in contrast to 
the waiver fee, shall not be required until the Agency makes a 
determination on the waiver request. Since the actual fee is submitted 
to an address different than the one to which the waiver request is 
submitted, a copy of the payment document must be submitted with the 
waiver request that is submitted to the Washington, DC address set forth 
in paragraph (a)(1) of this section. No fee is required from a person 
who has no financial interest in the application.
    (b) Procedures for payment of fees. All fees required by this 
section must be paid by money order, bank draft, or certified check 
drawn to the order of the Environmental Protection Agency. All payment 
of fees must be forwarded to the Environmental Protection Agency, 
Headquarters Accounting Operations Branch, Office of Pesticide Programs 
(Registration Fees), P.O. Box

[[Page 41]]

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]

Subparts V-Y [Reserved]



                           Subpart Z--Devices



Sec. 152.500  Requirements for devices.

    (a) A device is defined as any instrument or contrivance (other than 
a firearm) intended for trapping, destroying, repelling, or mitigating 
any pest or any other form of plant or animal life (other than man and 
other than a bacterium, virus, or other microorganism on or in living 
man or living animals) but not including equipment used for the 
application of pesticides (such as tamper-resistant bait boxes for 
rodenticides) when sold separately therefrom.
    (b) A device is not required to be registered under FIFRA sec. 3. 
The Agency has issued a policy statement concerning its authority and 
activities with respect to devices, which was published in the Federal 
Register of November 19, 1976 (41 FR 51065). A device is subject to the 
requirements set forth in:
    (1) FIFRA sec. 2(q)(1) and part 156 of this chapter, with respect to 
labeling;
    (2) FIFRA sec. 7 and part 167 of this chapter, with respect to 
establishment registration and reporting;
    (3) FIFRA sec. 8 and part 169 of this chapter, with respect to books 
and records;
    (4) FIFRA sec. 9, with respect to inspection of establishments;
    (5) FIFRA sec. 12, 13, and 14, with respect to violations, 
enforcement activities, and penalties;
    (6) FIFRA sec. 17, with respect to import and export of devices;
    (7) FIFRA sec. 25(c)(3), with respect to child-resistant packaging; 
and
    (8) FIFRA sec. 25(c)(4), with respect to the Agency's authority to 
declare devices subject to certain provisions of the Act.

[53 FR 15990, May 4, 1988. Redesignated at 60 FR 32096, June 19, 1995]



PART 153--REGISTRATION POLICIES AND INTERPRETATIONS--Table of Contents




Subparts A-F [Reserved]

        Subpart G--Determination of Active and Inert Ingredients

Sec.
153.125  Criteria for determination of pesticidal activity.

          Subpart H--Coloration and Discoloration of Pesticides

153.140  General.
153.155  Seed treatment products.

Subparts I-M [Reserved]

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

Subparts A-F [Reserved]



        Subpart G--Determination of Active and Inert Ingredients

    Source: 53 FR 15989, May 4, 1988, unless otherwise noted.



Sec. 153.125  Criteria for determination of pesticidal activity.

    (a) An ingredient will be considered an active ingredient if it is 
contained in a pesticide product and:
    (1) The ingredient has the capability by itself, and when used as 
directed at the proposed use dilution, to function as a pesticide; or
    (2) The ingredient has the ability to elicit or enhance a pesticidal 
effect in another compound whose pesticidal activity is substantially 
increased due to the interaction of the compounds. Compounds which 
function simply to enhance or prolong the activity of an active 
ingredient by physical action, such as stickers and other adjuvants,

[[Page 42]]

are not generally considered to be active ingredients.
    (b) Normally the applicant will determine and state in his 
application whether an ingredient is active or inert with respect to 
pesticidal activity. The Agency, as part of its review of an application 
for registration, or in conjunction with the Registration Standard or 
Special Review process, may require any ingredient, to be designated as 
an active ingredient if the Agency finds that it meets the criteria in 
paragraph (a) of this section. Conversely, the Agency may determine that 
any ingredient designated as active by an applicant is an inert 
ingredient if it fails to meet those criteria.
    (c) If an ingredient is designated as an active ingredient, it must 
be identified in the label ingredients statement. If an ingredient is 
designated as an inert ingredient, it must be included as part of the 
total inert ingredients in the label ingredients statement.
    (d) Designation of a substance as a pesticidally inert ingredient 
does not relieve the applicant or registrant of other requirements of 
FIFRA with respect to labeling of inert ingredients or submission of 
data, or from the requirements of the Federal Food, Drug, and Cosmetic 
Act with respect to tolerances or other clearance of ingredients.

[53 FR 15989, May 4, 1988, as amended at 60 FR 32096, June 19, 1995]



          Subpart H--Coloration and Discoloration of Pesticides

    Source: 53 FR 15990, May 4, 1988, unless otherwise noted.



Sec. 153.140  General.

    Section 25(c)(5) of the Act authorizes the Administrator to 
prescribe regulations requiring coloration or discoloration of any 
pesticide if the Administrator determines that such requirements are 
feasible and necessary for the protection of health and the environment. 
This subpart describes those pesticide products which must be colored or 
discolored.

[60 FR 32096, June 19, 1995]



Sec. 153.155  Seed treatment products.

    (a) Pesticide products intended for use in treating seeds must 
contain an EPA-approved dye to impart an unnatural color to the seed, 
unless appropriate tolerances or other clearances have been established 
under the Federal Food, Drug and Cosmetic Act for residues of the 
pesticide.
    (b) The following products are exempt from the requirement of 
paragraph (a) of this section:
    (1) Products intended and labeled for use solely by commercial seed 
treaters, provided that the label bears a statement requiring the user 
to add an EPA-approved dye with the pesticide during the seed treatment 
process.
    (2) Products intended and labeled for use solely as at-planting or 
hopper box treatments.
    (3) Products which are gaseous in form or are used as fumigants.
    (c) EPA-approved dyes are those listed in Sec. 180.1001 (c) and (d) 
of this chapter. Upon written request additional dyes will be considered 
for inclusion in this listing.

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.

[[Page 43]]

154.34  Expedited procedures.
154.35  Finality of determinations.

    Authority: 15 U.S.C. 136a, d, and w.

    Source: 50 FR 49015, Nov. 27, 1985, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 154.1  Purpose and scope.

    (a) Purpose. The purpose of the Special Review process is to help 
the Agency determine whether to initiate procedures to cancel, deny, or 
reclassify registration of a pesticide product because uses of that 
product may cause unreasonable adverse effects on the environment, in 
accordance with sections 3(c)(6) and 6 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). The process is intended to 
ensure that the Agency assesses risks that may be posed by pesticides, 
and the benefits of use of those pesticides, in an open and responsive 
manner. The issuance of a Notice of Special Review means that the Agency 
has determined that one or more uses of a pesticide may pose significant 
risks and that, following completion of the Special Review process, the 
Agency expects to initiate formal proceedings seeking to cancel, deny, 
reclassify, or require modifications to the registration of the 
product(s) in question unless it has been shown during the Special 
Review that the Agency's initial determination was erroneous, that the 
risks can be reduced to acceptable levels without the need for formal 
proceedings, or that the benefits of the pesticide's use outweigh the 
risks. Following completion of the Special Review process, a pesticide 
in question may be returned to the registration process.
    (b) Scope. This part sets forth the substantive standards for 
initiating a Special Review of a pesticide product and the procedures 
for initiating and conducting the Special Review.



Sec. 154.3  Definitions.

    (a) Except as otherwise defined in this section, terms defined in 
section 2 of FIFRA shall have the same definitions for purposes of this 
part.
    (b) The term Act or FIFRA means the Federal Insecticide, Fungicide, 
and Rodenticide Act, as amended, 7 U.S.C. 136 et seq.
    (c) The term Administrator means the Administrator of the 
Environmental Protection Agency or any officer or employee thereof to 
whom authority has been delegated to act for the Administrator.
    (d) The term confidential business information means trade secrets 
or confidential commercial or financial information under FIFRA section 
10(b) or 5 U.S.C. 552(b) (3) or (4).
    (e) The term other significant evidence means factually significant 
information that relates to the uses of the pesticide and their adverse 
risk to man or to the environment but does not include evidence based 
only on misuse of the pesticide unless such misuse is widespread and 
commonly recognized practice.
    (f) The term person means an applicant, registrant, manufacturer, 
pesticide user, environmental group, labor union, or other individual or 
group of individuals interested in pesticide regulation.
    (g) The term pesticide use means a use of a pesticide (discribed in 
terms of the application site and other applicable identifying factors) 
that is included in the labeling of a pesticide product which is 
registered, or for which an application for registration is pending, and 
the terms and conditions (or proposed terms and conditions) of 
registration for the use.
    (h) Terms and conditions of registration means the terms and 
conditions governing lawful sale, distribution, and use approved in 
conjunction with registration, including labeling, use classification, 
composition, and packaging.
    (i) The term validated test means a test determined by the Agency to 
have been conducted and evaluated in a manner consistent with accepted 
scientific procedures



Sec. 154.5  Burden of persuasion in determinations under this part.

    In making determinations under this part the Administrator shall be 
guided by the principle that the burden of persuasion that a pesticide 
product is entitled to registration or continued registration for any 
particular use or under any particular set of terms and

[[Page 44]]

conditions of registration is always on the proponent(s) of 
registration.



Sec. 154.7  Criteria for initiation of Special Review.

    (a) The Administrator may conduct a Special Review of a pesticide 
use if he determines, based on a validated test or other significant 
evidence, that the use of the pesticide (taking into account the 
ingredients, impurities, metabolites, and degradation products of the 
pesticide):
    (1) May pose a risk of serious acute injury to humans or domestic 
animals.
    (2) May pose a risk of inducing in humans an oncogenic, heritable 
genetic, teratogenic, fetotoxic, reproductive effect, or a chronic or 
delayed toxic effect, which risk is of concern in terms of either the 
degree of risk to individual humans or the number of humans at some 
risk, based upon:
    (i) Effects demonstrated in humans or experimental animals.
    (ii) Known or predicted levels of exposure of various groups of 
humans.
    (iii) The use of appropriate methods of evaluating data and relating 
such data to human risk.
    (3) May result in residues in the environment of nontarget organisms 
at levels which equal or exceed concentrations acutely or chronically 
toxic to such organisms, or at levels which produce adverse reproductive 
effects in such organisms, as determined from tests conducted on 
representative species or from other appropriate data.
    (4) May pose a risk to the continued existence of any endangered or 
threatened species designated by the Secretary of the Interior or the 
Secretary of Commerce under the Endangered Species Act of 1973, as 
amended.
    (5) May result in the destruction or other adverse modification of 
any habitat designated by the Secretary of the Interior or the Secretary 
of Commerce under the Endangered Species Act as a critical habitat for 
any endangered or threatened species.
    (6) May otherwise pose a risk to humans or to the environment which 
is of sufficient magnitude to merit a determination whether the use of 
the pesticide product offers offsetting social, economic, and 
environmental benefits that justify initial or continued registration.
    (b) In making any determination that a pesticide use satisfies one 
of the criteria for issuance of a Special Review specified by paragraph 
(a) of this section, the Administrator shall consider available evidence 
concerning both the adverse effect in question and the magnitude and 
scope of exposure of humans and nontarget organisms associated with use 
of the pesticide.



Sec. 154.10  Petitions to begin the Special Review process.

    The Administrator may evaluate a pesticide use under the criteria of 
Sec. 154.7 either on his own initiative, or at the suggestion of any 
interested person.



Sec. 154.15  Docket for the Special Review.

    (a) Establishment of the docket. When the Agency first notifies 
registrants privately that it is considering issuance of a Notice of 
Special Review for a pesticide, it shall establish a docket concerning 
that particular pesticide.
    (b) Contents of the docket. For each pre-Special Review or Special 
Review, the docket shall contain:
    (1) The Notice of Special Review, any Notice of Preliminary 
Determination, and any Notice of Final Determination.
    (2) Any notice issued under Sec. 154.21 or Sec. 154.23.
    (3) Any documents (other than information claimed to be confidential 
business information) referred to by the Agency in those notices as 
relied upon by the Agency in reaching its determination.
    (4) Copies of all written comments or materials (other than 
information 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.

[[Page 45]]

    (7) A memorandum describing each meeting between Agency personnel 
and any person or party outside of government which concerns a pending 
pre-Special Review or Special Review decision. Each such memorandum 
shall be based on notes taken at the meeting and shall specify the date 
and time of the meeting, the participants and their affiliations, who 
requested the meeting, the subject matter of the meeting, and the person 
who prepared the memorandum. Except for information claimed to be 
confidential business information, each memorandum shall describe fully 
and accurately all significant positions taken, arguments made, and 
facts presented by each participant in the meeting, and shall identify 
all documents, proposals, or other materials distributed or exchanged at 
the meeting. Any discussion of claimed confidential business information 
shall be identified in meeting notes and referenced in the memorandum.
    (8) All comments, correspondence, or other materials concerning a 
pending pre-Special Review or Special Review decision provided to the 
Agency by a person or party outside of government (other than 
information claimed to be confidential business information).
    (9) All documents, proposals, or other materials concerning a 
pending pre-Special Review or Special Review decision, provided by the 
Agency to any person or party outside of government (other than 
information claimed to be confidential business information).
    (c) Assertion of confidential business information claims. (1) 
Information, comments, data, or other written material submitted to the 
Agency concerning a Special Review may be claimed by the submitter to be 
confidential business information. The burden of identifying claimed 
confidential business information rests with the submitter, or, in 
meetings, with the participants who wish to assert a claim of 
confidentiality.
    (2) To assert a claim of confidentiality for all or any part of a 
written submission concerning a Special Review, the submitter must 
furnish three copies of the material. Two copies must be complete, with 
claimed confidential business information clearly marked in the text. 
Items in the document that are claimed confidential should be numbered 
consecutively throughout the text. The third copy must have the claimed 
confidential business information excised from the text without closing 
up or paraphrasing the remaining text. The deletions should be 
consecutively numbered to correspond to the numbering of the complete 
copies. Each copy must be marked on the cover as to whether it contains 
claimed confidential business information.
    (3) Any written material concerning a Special Review received by the 
Agency that is not marked as confidential will be deemed to be 
nonconfidential, and may be made available through the public docket or 
otherwise disclosed without prior notice to the submitter.
    (d) Placement of materials in the docket. Any memorandum identified 
under paragraph (b)(7) of this section shall be placed in the docket 
within 10 working days of the subject meeting. Materials identified 
under paragraph (b)(8) of this section shall be placed in the docket 
within 10 working days of receipt by the Office of Pesticide Programs, 
or within 15 working days of receipt by the Office of Pesticide Programs 
if the submitter has asserted a confidential business information claim 
concerning the submittal. Materials identified under paragraph (b)(9) of 
this section shall be placed in the docket within 15 working days of 
transmittal to such person or party outside of government.
    (e) Index. The Agency shall prepare and maintain a current index of 
all materials included in the docket. The index will include a list 
identifying, for each meeting between Agency personnel and a person or 
party outside of government for which a memorandum 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

[[Page 46]]

issued a pre-Special Review notification under Sec. 154.21 will only be 
made available for public inspection and copying following issuance of a 
proposed decision not to start a Special Review under Sec. 154.23, a 
Notice of Special Review under Sec. 154.25(c), or as otherwise specified 
in Sec. 154.34.
    (ii) The docket and index will be available at the Program 
Management and Support Division, in Rm. 236, CM2, 1921 Jefferson Davis 
Highway, Arlington, VA, from 8 a.m. to 4 p.m. Monday through Friday, 
excluding legal holidays.
    (2) Information contained in the docket shall not be disclosed to 
the public to the extent that FIFRA or any other statute or regulation 
(including, but not limited to, 5 U.S.C. 552(b)(3) or (4)) prohibits its 
disclosure.
    (3) The Agency will distribute a compendium of indices for new 
materials in the public docket by mail, on a monthly basis, to those 
members of the public who have specifically requested such material. The 
Agency will announce the availability of docket indices both annually in 
the Federal Register and in each Federal Register Notice concerning pre-
Special Review or Special Review for specific pesticides. The Agency may 
also periodically require parties on the mailing list to renew their 
previous request for such materials.



                          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.

[[Page 47]]

    (4) An invitation to all interested persons to submit further 
information concerning the risks and benefits associated with each use 
of the pesticide subject to the Special Review.
    (5) A brief description of the Special Review process and a 
statement that registrants and applicants bear an affirmative burden of 
supporting registration of a pesticide product.
    (6) A date by which information in response to the Agency's request 
for further information must be submitted.
    (d) In his discretion, the Administrator may request that the 
Scientific Advisory Panel hold a public meeting to review the scientific 
issues related to the Special Review.



Sec. 154.26  Comment opportunity.

    After issuance of a Notice of Special Review that applies to a use 
of a pesticide product (or category of products), any person may submit 
to the Agency any information, argument, or both, pertinent to:
    (a) Whether the use of a pesticide product satisfies any of the 
Sec. 154.7 risk criteria, with respect to the composition, labeling, 
packaging, and restrictions on use of the product as currently 
registered.
    (b) Whether the use of a pesticide product would satisfy any of the 
Sec. 154.7 risk criteria if its composition, labeling, packaging, and 
restrictions on use were approved in accordance with an application for 
registration or amended registration pending before the Agency. For 
further information see Sec. 154.27(b).
    (c) Whether any risks posed by the use or proposed use of the 
product that satisfy the Sec. 154.7 risk criteria are unreasonable, 
taking into account the economic, social, and environmental costs and 
benefits of the use of the product.
    (d) What regulatory action, if any, the Agency should take with 
respect to the use of the product.



Sec. 154.27  Meetings with interested persons.

    (a) In the Special Review process, to assure openness and 
responsiveness, no person or party outside of government will be 
afforded special or preferential access to Agency Special Review 
decisionmakers or to the Agency's Special Review process. At the same 
time, however, Agency personnel are free to meet and otherwise 
communicate with persons or parties outside of government, including 
registrants and manufacturers, users, trade unions, environmental groups 
and other interested persons, to obtain information, exchange views, 
explore factual and substantive positions, or discuss regulatory options 
concerning Special Review decisions.
    (b) Meetings between EPA and any person or party outside of 
government will not result in undue delay in reaching Special Review 
decisions. During such meetings, the Agency will not commit to take any 
particular action concerning a pending decision. The Agency may receive 
and consider information and recommendations from persons or parties 
outside of government; however, the Agency will make the final 
administrative decision on a wholly independent basis and in accordance 
with law.
    (c) Any interested person may ask to meet with Agency officials to 
discuss factual information available to the Agency, to present any 
factual information, to respond to presentations by other persons, or to 
discuss what regulatory actions should be taken regarding a pesticide 
which is or may be the subject of a Special Review. If, at its 
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

[[Page 48]]

the issuance of the Notice of Special Review.
    (e) If the Agency meets with any person or party outside of 
government concerning a pending Special Review decision, the Agency will 
not issue a final Special Review decision until 30 days after inclusion 
of a memorandum concerning that meeting in the public docket. During 
those 30 days, any person or party may submit written comments to the 
Agency regarding the subject matter of the meeting in question. The 
Agency may issue a final Special Review decision without allowing this 
30-day period if expedited action is necessary to protect public health 
or the environment, or if the Agency has invited other parties with 
potentially opposing viewpoints to the meeting in question (e.g., 
registrants, users, labor, and environmental groups).
    (f) The Agency may decline to meet subsequently with any person or 
party who asserts unreasonable confidential business information claims 
pursuant to Sec. 154.15(c) for the purpose of circumventing the 
docketing procedures described in Sec. 154.15(b).



Sec. 154.29  Informal public hearings.

    (a) Timing. At any time after issuance of a Notice of Special Review 
and prior to issuance of a Notice of Final Determination, the 
Administrator may conduct an informal public hearing to gather relevant 
information or otherwise assist Agency decisionmaking.
    (b) Federal Register notice. The Administrator shall issue a notice 
for publication in the Federal Register of any informal public hearing 
to be held under this section. The notice shall contain the following 
information:
    (1) The time, date, and place of the hearing.
    (2) A brief description of the procedures governing participation in 
the hearing by interested persons.
    (3) The issues to be considered at the hearing.
    (c) Transcript. A verbatim transcript of the hearing shall be 
prepared and filed in the public docket.



Sec. 154.31  Notices of Preliminary Determination.

    The Administrator shall prepare a Notice of Preliminary 
Determination after the close of the comment period on a Notice of 
Special Review.
    (a) Contents of notice. The Notice of Preliminary Determination 
shall respond to all significant comments submitted in response to the 
Notice of Special Review. For each use of a pesticide product that was 
the subject of the Notice of Special Review, the Notice of Preliminary 
Determination shall also include, as appropriate:
    (1) A determination whether the use satisfies any of the risk 
criteria set forth in Sec. 154.7, and a discussion of the reasons for 
the determination.
    (2) A determination of whether any changes in the composition, 
packaging, labeling, or restrictions on use of a pesticide product that 
were proposed in an application for new or amended registration 
submitted after issuance of the Notice of Special Review would reduce 
the risk so that the use no longer would satisfy any of the risk 
criteria in Sec. 154.7.
    (3) If the use satisfies any of the risk criteria set forth in 
Sec. 154.7, a determination of whether the adverse effects posed by the 
use are unreasonable, taking into account the economic, social, and 
environmental costs and benefits of the use of the product, and a 
discussion of reasons for the determination.
    (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

[[Page 49]]

docket will be available for inspection and copying.
    (b) Referral to Secretary of Agriculture and Scientific Advisory 
Panel. If the Administrator proposes to cancel, deny, or change the 
classification of the registration of a pesticide product which is the 
subject of a Special Review, or to hold a hearing under FIFRA section 
6(b)(2) on whether to take any of those actions, he shall:
    (1) Prepare a proposed form of a Notice of Intent to Cancel, a 
Notice of Intent to Deny Registration, a Notice of Intent to Hold a 
Hearing, and/or a Notice of Intent to Change Classification, as 
appropriate.
    (2) Prepare an Agricultural Impact Analysis, analyzing the impact of 
the proposed action on production and prices of agricultural 
commodities, retail food prices, and otherwise on the agricultural 
economy.
    (3) Send the proposed notices and analysis to the Secretary of 
Agriculture and the Scientific Advisory Panel for comment, as provided 
by the Act.
    (4) Send the Notice of Preliminary Determination and the other 
notices and analysis prepared under this section to all registrants and 
applicants for registration of products that are subject to the Special 
Review.
    (c) Publication. The Agency shall issue the Notice of Preliminary 
Determination for publication in the Federal Register.



Sec. 154.33  Notice of Final Determination.

    (a) Publication and notice to registrants and applicants. The 
Administrator shall prepare a Notice of Final Determination after the 
close of the comment period on a Notice of Preliminary Determination. As 
necessary, the Administrator shall also prepare Notices of Intent to 
Cancel, Notices of Denial, Notices of Intent to Hold a Hearing under 
FIFRA section 6(b)(2), or Notices of Intent to Change Classification.
    (b) Contents. The Notice of Final Determination shall include:
    (1) For each pesticide use subject to the Notice of Preliminary 
Determination, the Agency's final determination with respect to each 
use, along with a discussion of the reasons for the determination.
    (2) Any comments submitted by the Secretary of Agriculture or the 
Scientific Advisory Panel, and the responses of the Administrator to 
these comments.
    (3) The response of the Administrator to any significant public 
comments submitted on the Notice of Preliminary Determination.
    (4) Instructions to registrants, applicants for registration, and 
other interested persons concerning the procedures which will be used to 
implement any regulatory action which the Administrator has decided 
upon, including instructions concerning how to request hearings, if 
hearings are available as of right under the Act or have been made 
available by the Administrator under the Act.
    (5) The location of the docket under Sec. 154.15 and the times 
during which the docket will be available for inspection and copying.
    (c) Publication and notification of registrants and applicants. The 
Notice of Final Determination and any Notice of Intent to Cancel, Notice 
of Denial, Notice of Intent to Hold a Hearing, or Notice of Intent to 
Change Classification shall be published in the Federal Register. If the 
Administrator issues a Notice of Intent to Cancel, Notice of Denial, 
Notice of Intent to Hold a Hearing, or Notice of Intent to Change 
Classification, such notice, along with the Notice of Final 
Determination, also shall be sent by certified mail to all affected 
registrants and applicants.



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).

[[Page 50]]



Sec. 154.35  Finality of determinations.

    (a) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposes registration of a product for a use 
which earlier had been the subject of a notice under Sec. 154.21(a);
    (2) After the Administrator issued the notice, he determined not to 
initiate a Special Review, because of a proposal by an applicant for 
registration or amended registration to change the terms and conditions 
of registration of the product in a way which would reduce the risk 
sufficiently to eliminate the need for a Special Review; and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions which served as the basis of the 
earlier determination be eliminated, or be modified in a way which might 
increase the risk which was the subject of the notice under 
Sec. 154.21(a).
    (b) The Administrator will not approve an application for 
registration or amended registration of a pesticide product except by 
use of the procedures specified in paragraph (c) of this section, if:
    (1) The application proposed registration of a product for a use 
which earlier had been the subject of a Notice of Special Review issued 
under Sec. 154.25;
    (2) After the Administrator issued that Notice, he determined not to 
issue a notice under FIFRA section 3(c)(6) or 6(b) because of a proposal 
by an applicant for registration or amended registration to change the 
terms and conditions of registration of the product in a way which would 
reduce the risk sufficiently to eliminate the need for issuance of a 
notice under FIFRA section 3(c)(6) or 6(b); and
    (3) The application for registration or amended registration now 
proposes that the terms and conditions of registration which served as 
the basis for the earlier determination now be eliminated or be modified 
in a way which might increase the risk which was the subject of the 
Notice of Special Review.
    (c) An application to which paragraph (a) or (b) of this section 
applies may not be approved until:
    (1) The Administrator issues a notice for publication in the Federal 
Register which describes why the application is subject to the 
provisions of this section, states that the Administrator proposes to 
approve the application and his reasons, solicits public comment on 
whether the application should be approved, and provides a period not 
less than 30 days for comments to be submitted; and
    (2) If any substantive comments are submitted in response to the 
notice, the Administrator issues a second notice for publication in the 
Federal Register responding to the comments.



PART 155--REGISTRATION STANDARDS--Table of Contents




Subpart A [Reserved]

        Subpart B--Docketing and Public Participation Procedures

Sec.
155.23  Definitions.
155.25  Schedule.
155.27  Agency review of data.
155.30  Meetings and communications.
155.32  Public docket.
155.34  Notice of availability.

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

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

Subpart A [Reserved]



        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 51]]

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 52]]

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 53]]

    (7) With respect to a Registration Standard for which the Agency has 
determined that a substantially complete chronic health and teratology 
data base exists, a copy of the Federal Register notice concerning 
availability of a proposed Registration Standard, and a copy of each 
comment received in response to that notice (within 10 working days 
after receipt by the Agency, or 15 working days if the submitter has 
asserted a confidential business information claim concerning the 
material).
    (8) A copy of the Federal Register notice announcing the issuance of 
the Registration Standard (within 10 working days after the publication 
of the notice).
    (c) Index of the docket. The Agency will establish and keep current 
an index to the docket for each Registration Standard. The index will 
include, but is not limited to:
    (1) A list of each meeting between the Agency and any person or 
party outside of government, containing the date and subject of the 
meeting, the names of participants and the name of the person requesting 
the meeting.
    (2) A list of each document in the docket by title, source or 
recipient(s), and the date the document was received or provided by the 
Agency.
    (d) Availability of docket and indices. (1) The Agency will make 
available to the public for inspection and copying the docket and index 
for any Registration Standard.
    (2) The Agency will establish and maintain a mailing list of persons 
who have specifically requested that they receive indices for 
Registration Standard dockets. On a quarterly basis, EPA will distribute 
the indices of new materials placed in the public docket to these 
persons. Annually, EPA will require that persons on the list renew their 
requests for inclusion on the list.
    (3) The Agency will issue annually in the Federal Register (in 
conjunction with the annual schedule notice specified in Sec. 155.25) a 
notice announcing the availability of docket indices.
    (4) Each Federal Register notice of availability of a Registration 
Standard will announce the availability of the docket index for that 
Standard.



Sec. 155.34  Notice of availability.

    (a) The Agency will issue in the Federal Register a notice 
announcing the issuance and availability of Registration Standard which:
    (1) Concerns a previously unregistered active ingredient; or
    (2) Concerns a previously registered active ingredient, and the 
Registration Standard states that registrants will be required (under 
FIFRA section 3(c)(2)(B)) to submit chronic health (including, but not 
limited to, chronic feeding, oncogenicity and reproduction) or 
teratology studies.
    (b) Interested persons may submit comments concerning any 
Registration Standard described by paragraph (a) of this section at any 
time.
    (c) The Agency will issue in the Federal Register a notice 
announcing the availability of, and providing opportunity for comment 
on, each proposed Registration Standard which concerns a previously 
registered active ingredient for which the Agency has determined that a 
substantially complete chronic health and teratology data base exists. 
Following the comment period and issuance of the Registration Standard, 
the Agency will issue in the Federal Register a notice of availability 
of the Registration Standard.



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




                      Subpart A--General Provisions

Sec.
156.10  Labeling requirements.

Subparts B-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.

[[Page 54]]



                      Subpart A--General Provisions



Sec. 156.10  Labeling requirements.

    (a) General--(1) Contents of the label. Every pesticide products 
shall bear a label containing the information specified by the Act and 
the regulations in this part. The contents of a label must show clearly 
and prominently the following:
    (i) The name, brand, or trademark under which the product is sold as 
prescribed in paragraph (b) of this section;
    (ii) The name and address of the producer, registrant, or person for 
whom produced as prescribed in paragraph (c) of this section;
    (iii) The net contents as prescribed in paragraph (d) of this 
section;
    (iv) The product registration number as prescribed in paragraph (e) 
of this section;
    (v) The producing establishment number as prescribed in paragraph 
(f) of this section;
    (vi) An ingredient statement as prescribed in paragraph (g) of this 
section;
    (vii) Warning or precautionary statements as prescribed in paragraph 
(h) of this section;
    (viii) The directions for use as prescribed in paragraph (i) of this 
section; and
    (ix) The use classification(s) as prescribed in paragraph (j) of 
this section.
    (2) Prominence and legibility. (i) All words, statements, graphic 
representations, designs or other information required on the labeling 
by the Act or the regulations in this part must be clearly legible to a 
person with normal vision, and must be placed with such conspicuousness 
(as compared with other words, statements, designs, or graphic matter on 
the labeling) and expressed in such terms as to render it likely to be 
read and understood by the ordinary individual under customary 
conditions of purchase and use.
    (ii) All required label text must:
    (A) Be set in 6-point or larger type;
    (B) Appear on a clear contrasting background; and
    (C) Not be obscured or crowded.
    (3) Language to be used. All required label or labeling text shall 
appear in the English language. However, the Agency may require or the 
applicant may propose additional text in other languages as is 
considered necessary to protect the public. When additional text in 
another language is necessary, all labeling requirements will be applied 
equally to both the English and other-language versions of the labeling.
    (4) Placement of Label--(i) General. The label shall appear on or be 
securely attached to the immediate container of the pesticide product. 
For purposes of this section, and the misbranding provisions of the Act, 
``securely attached'' shall mean that a label can reasonably be expected 
to remain affixed during the foreseeable conditions and period of use. 
If the immediate container is enclosed within a wrapper or outside 
container through which the label cannot be clearly read, the label must 
also be securely attached to such outside wrapper or container, if it is 
a part of the package as customarily distributed or sold.
    (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

[[Page 55]]

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
    (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

[[Page 56]]

deviation unavoidable in good manufacturing practice. Variation below a 
stated minimum is not permitted. In no case shall the average content of 
the packages in a shipment fall below the stated average content.
    (e) Product registration number. The registration number assigned to 
the pesticide product at the time of registration shall appear on the 
label, preceded by the phrase ``EPA Registration No.,'' or the phrase 
``EPA Reg. No.'' The registration number shall be set in type of a size 
and style similar to other print on that part of the label on which it 
appears and shall run parallel to it. The registration number and the 
required identifying phrase shall not appear in such a manner as to 
suggest or imply recommendation or endorsement of the product by the 
Agency.
    (f) Producing establishments registration number. The producing 
establishment registration number preceded by the phrase ``EPA Est.'', 
of the final establishment at which the product was produced may appear 
in any suitable location on the label or immediate container. It must 
appear on the wrapper or outside container of the package if the EPA 
establishment registration number on the immediate container cannot be 
clearly read through such wrapper or container.
    (g) Ingredient statement--(1) General. The label of each pesticide 
product must bear a statement which contains the name and percentage by 
weight of each active ingredient, the total percentage by weight of all 
inert ingredients; and if the pesticide contains arsenic in any form, a 
statement of the percentages of total and water-soluble arsenic 
calculated as elemental arsenic. The active ingredients must be 
designated by the term ``active ingredients'' and the inert ingredients 
by the term ``inert ingredients,'' or the singular forms of these terms 
when appropriate. Both terms shall be in the same type size, be aligned 
to the same margin and be equally prominent. The statement ``Inert 
Ingredients, none'' is not required for pesticides which contain 100 
percent active ingredients. Unless the ingredient statement is a 
complete analysis of the pesticide, the term ``analysis'' shall not be 
used as a heading for the ingredient statement.
    (2) Position of ingredient statement. (i) The ingredient statement 
is normally required on the front panel of the label. If there is an 
outside container or wrapper through which the ingredient statement 
cannot be clearly read, the ingredient statement must also appear on 
such outside container or wrapper. If the size or form of the package 
makes it impracticable to place the ingredient statement on the front 
panel of the label, permission may be granted for the ingredient 
statement to appear elsewhere.
    (ii) The text of the ingredient statement must run parallel with 
other text on the panel on which it appears, and must be clearly 
distinguishable from and must not be placed in the body of other text.
    (3) Names to be used in ingredient statement. The name used for each 
ingredient shall be the accepted common name, if there is one, followed 
by the chemical name. The common name 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:

[[Page 57]]

    (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) Warnings and precautionary statements. Required warnings and 
precautionary statements concerning the general areas of toxicological 
hazard including hazard to children, environmental hazard, and physical 
or chemical hazard fall into two groups; those required on the front 
panel of the labeling and those which may appear elsewhere. Specific 
requirements concerning content, placement, type size, and prominence 
are given below.
    (1) Required front panel statements. With the exception of the child 
hazard warning statement, the text required on the front panel of the 
label is determined by the Toxicity Category of the pesticide. The 
category is assigned on the basis of the highest hazard shown by any of 
the indicators in the table below:

----------------------------------------------------------------------------------------------------------------
                                                                Toxicity categories
        Hazard indicators        -------------------------------------------------------------------------------
                                           I                  II                  III                 IV
----------------------------------------------------------------------------------------------------------------
Oral LD50.......................  Up to and           From 50 thru 500    From 500 thru 5000  Greater than 5000
                                   including 50 mg/    mg/kg.              mg/kg.              mg/kg.
                                   kg.
Inhalation LC 50................  Up to and           From .2 thru 2 mg/  From 2. thru 20 mg/ Greater than 20 mg/
                                   including .2 mg/    liter.              liter.              liter.
                                   liter.
Dermal LD 50....................  Up to and           From 200 thru 2000  From 2,000 thru     Greater than
                                   including 200 mg/                       20,000.             20,000.
                                   kg.
Eye effects.....................  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 effects....................  Corrosive.........  Severe irritation   Moderate            Mild or slight
                                                       at 72 hours.        irritation at 72    irritation at 72
                                                                           hours.              hours.
----------------------------------------------------------------------------------------------------------------

    (i) Human hazard signal word--(A) Toxicity Category I. All pesticide 
products meeting the criteria of Toxicity Category I shall bear on the 
front panel the signal word ``Danger.'' In addition if the product was 
assigned to Toxicity Category I on the basis of its oral, inhalation or 
dermal toxicity (as distinct from skin and eye local effects) the word 
``Poison'' shall appear in red on a background of distinctly contrasting 
color and the skull and crossbones shall appear in immediate proximity 
to the word ``poison.''
    (B) Toxicity Category II. All pesticide products meeting the 
criteria of Toxicity Category II shall bear on the front panel the 
signal word ``Warning.''
    (C) Toxicity Category III. All pesticide products meeting the 
criteria of Toxicity Category III shall bear on the front panel the 
signal word ``Caution.''
    (D) Toxicity Category IV. All pesticide products meeting the 
criteria of Toxicity Category IV shall bear on the front panel the 
signal word ``Caution.''
    (E) Use of signal words. Use of any signal word(s) associated with a 
higher Toxicity Category is not permitted except when the Agency 
determines that such labeling is necessary to prevent unreasonable 
adverse effects on man or the environment. In no case shall more than 
one human hazard signal word appear on the front panel of a label.
    (ii) Child hazard warning. Every pesticide product label shall bear 
on the front panel the statement ``keep out of reach of children.'' Only 
in cases where the likelihood of contact with children during 
distribution, marketing, storage or use is demonstrated by the applicant 
to be extremely remote, or if the nature of the pesticide is such that 
it is approved for use on infants or small children, may the 
Administrator waive this requirement.
    (iii) Statement of practical treatment--(A) Toxicity Category I. A 
statement of

[[Page 58]]

practical treatment (first aid or other) shall appear on the front panel 
of the label of all pesticides falling into Toxicity Category I on the 
basis of oral, inhalation or dermal toxicity. The Agency may, however, 
permit reasonable variations in the placement of the statement of 
practical treatment is some reference such as ``See statement of 
practical treatment on back panel'' appears on the front panel near the 
word ``Poison'' and the skull and crossbones.
    (B) Other toxicity categories. The statement of practical treatment 
is not required on the front panel except as described in paragraph 
(h)(1)(iii)(A) of this section. The applicant may, however, include such 
a front panel statement at his option. Statements of practical treatment 
are, however, required elsewhere on the label in accord with paragraph 
(h)(2) of this section if they do not appear on the front panel.
    (iv) Placement and prominence. All the require 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 following table shows the minimum 
type size requirements for the front panel warning statements on various 
sizes of labels:

------------------------------------------------------------------------
                                                          Points
                                                 -----------------------
                                                   Required   ``Keep out
   Size of label front panel in square inches       signal     of reach
                                                   word, all      of
                                                   capitals   children''
------------------------------------------------------------------------
5 and under.....................................           6           6
Above 5 to 10...................................          10           6
Above 10 to 15..................................          12           8
Above 15 to 30..................................          14          10
Over 30.........................................          18          12
------------------------------------------------------------------------

    (2) Other required warnings and precautionary statements. The 
warnings and precautionary statements as required below shall appear 
together on the label under the general heading ``Precautionary 
Statements'' and under appropriate subheadings of ``Hazard to Humans and 
Domestic Animals,'' ``Environmental Hazard'' and ``Physical or Chemical 
Hazard.''
    (i) Hazard to humans and domestic animals. (A) Where a hazard exists 
to humans or domestic animals, precautionary statements are required 
indicating the particular hazard, the route(s) of exposure and the 
precautions to be taken to avoid accident, injury or damage. The 
precautionary paragraph shall be immediately preceded by the appropriate 
hazard signal word.
    (B) The following table depicts typical precautionary statements. 
These statements must be modified or expanded to reflect specific 
hazards.

------------------------------------------------------------------------
                      Precautionary statements by toxicity category
   Toxicity    ---------------------------------------------------------
   category     Oral, inhalation, or dermal
                          toxicity            Skin and eye local effects
------------------------------------------------------------------------
I.............  Fatal (poisonous) if         Corrosive, causes eye and
                 swallowed [inhaled or        skin damage [or skin
                 absorbed through skin]. Do   irritation]. Do not get in
                 not breathe vapor [dust or   eyes, on skin, or on
                 spray mist]. Do not get in   clothing. Wear goggles or
                 eyes, on skin, or on         face shield and rubber
                 clothing [Front panel        gloves when handling.
                 statement of practical       Harmful or fatal if
                 treatment required.].        swallowed. [Appropriate
                                              first aid statement
                                              required.]
II............  May be fatal if swallowed    Causes eye [and skin]
                 [inhaled or absorbed         irritation. Do not get in
                 through the skin]. Do not    eyes, on skin, or on
                 breathe vapors [dust or      clothing. Harmful if
                 spray mist]. Do not get in   swallowed. [Appropriate
                 eyes, on skin, or on         first aid statement
                 clothing. [Appropriate       required.]
                 first aid statements
                 required.].
III...........  Harmful if swallowed         Avoid contact with skin,
                 [inhaled or absorbed         eyes or clothing. In case
                 through the skin]. Avoid     of contact immediately
                 breathing vapors [dust or    flush eyes or skin with
                 spray mist]. Avoid contact   plenty of water. Get
                 with skin [eyes or           medical attention if
                 clothing]. [Appropriate      irritation persists.
                 first aid statement
                 required.].
IV............  [No precautionary            [No precautionary
                 statements required.].       statements required.]
------------------------------------------------------------------------

    (ii) Environmental hazards. Where a hazard exists to non target 
organisms excluding humans and domestic animals, precautionary 
statements are required stating the nature of the hazard and the 
appropriate precautions to avoid potential accident, injury or damage. 
Examples of the hazard statements and the circumstances under which they 
are required follow:
    (A) If a pesticide intended for outdoor use contains an active 
ingredient with

[[Page 59]]

a mammalian acute oral LD50 of 100 or less, the statement 
``This Pesticide is Toxic to Wildlife'' is required.
    (B) 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.
    (C) 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.
    (D) If either accident history or field studies demonstrate that 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.
    (E) For uses involving foliar application to agricultural crops, 
forests, or shade trees, or for mosquito abatement treatments, 
pesticides toxic to pollinating insects must bear appropriate label 
cautions.
    (F) For all outdoor uses 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.''
    (iii) Physical or chemical hazards. (A) Warning statements on the 
flammability or explosive characteristics of all pesticides are required 
as set out in Table 1 and Table 2 of this paragraph as follows:

                     Table 1--Pressurized Containers
------------------------------------------------------------------------
              Flash Point                         Required Text
------------------------------------------------------------------------
Flash point at or below 20  deg.F; if    Extremely flammable. Contents
 there is a flashback at any valve        under pressure. Keep away from
 opening                                  fire, sparks, and heated
                                          surfaces. Do not puncture or
                                          incinerate container. Exposure
                                          to temperatures above 130
                                          deg.F may cause bursting
 
Flash point above 20  deg.F and not      Flammable. Contents under
 over 80  deg.F or if the flame           pressure. Keep away from heat,
 extension is more than 18 inches long    sparks, and open flame. Do not
 at a distance of 6 inches from the       puncture or incinerate
 flame                                    container. Exposure to
                                          temperatures above 130  deg.F
                                          may cause bursting
 
All other pressurized containers         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.
------------------------------------------------------------------------


                   Table 2--Nonpressurized Containers
------------------------------------------------------------------------
              Flash Point                         Required Text
------------------------------------------------------------------------
At or below 20  deg.F                    Extremely flammable. Keep away
                                          from fire, sparks, and heated
                                          surfaces.
 
Above 20  deg.F and not over 80  deg.F   Flammable. Keep away from heat
                                          and open flame.
 
Above 80  deg.F and not over 150  deg.F  Do not use or store near heat
                                          or open flame.
------------------------------------------------------------------------

    (B) 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.
    (C)(1) If the 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:

    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.

    (2) 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.

[[Page 60]]

[GRAPHIC] [TIFF OMITTED] TR23FE98.000

    (i) Directions for Use--(1) General requirements--(i) Adequacy and 
clarity of directions. Directions for use must be stated in terms which 
can be easily read and understood by the average person likely to use or 
to supervise the use of the pesticide. When followed, directions must be 
adequate to protect the public from fraud and from personal injury and 
to prevent unreasonable adverse effects on the environment.
    (ii) Placement of directions for use. Directions may appear on any 
portion of the label provided that they are conspicuous enough to be 
easily read by the user of the pesticide product. Directions for use may 
appear on printed or graphic matter which accompanies the pesticide 
provided that:
    (A) If required by the Agency, such printed or graphic matter is 
securely attached to each package of the pesticide, or placed within the 
outside wrapper or bag;
    (B) The label bears a reference to the directions for use in 
accompanying leaflets or circulars, such as ``See directions in the 
enclosed circular:'' and
    (C) The Administrator determines that it is not necessary for such 
directions to appear on the label.
    (iii) Exceptions to requirement for direction for use. (A) Detailed 
directions for use may be omitted from labeling of pesticides which are 
intended for use only by manufacturers of products other than pesticide 
products in their regular manufacturing processes, provided that:
    (1) The label clearly shows that the product is intended for use 
only in manufacturing processes and specifies the type(s) of products 
involved.
    (2) Adequate information such as technical data sheets or bulletins, 
is available to the trade specifying the type of product involved and 
its proper use in manufacturing processes;
    (3) The product will not come into the hands of the general public 
except after incorporation into finished products; and
    (4) The Administrator determines that such directions are not 
necessary to prevent unreasonable adverse effects on man or the 
environment.
    (B) Detailed directions for use may be omitted from the labeling of 
pesticide products for which sale is limited to physicians, 
veterinarians, or druggists, provided that:
    (1) The label clearly states that the product is for use only by 
physicians or veterinarians;
    (2) The Administrator determines that such directions are not 
necessary 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

[[Page 61]]

product in a manner inconsistent with its labeling.''
    (iii) The site(s) of application, as for example the crops, animals, 
areas, or objects to be treated.
    (iv) The target pest(s) associated with each site.
    (v) The dosage rate associated with each site and pest.
    (vi) The method of application, including instructions for dilution, 
if required, and type(s) of application apparatus or equipment required.
    (vii) The frequency and timing of applications necessary to obtain 
effective results without causing unreasonable adverse effects on the 
environment.
    (viii) Worker protection statements meeting the requirements of 
subpart K of this part.
    (ix) Specific directions concerning the storage and disposal of the 
pesticide and its container, meeting the requirements of 40 CFR part 
165. These instructions shall be grouped and appear under the heading 
``Storage and Disposal.'' This heading must be set in type of the same 
minimum sizes as required for the child hazard warning. (See table in 
Sec. 162.10(h)(1)(iv))
    (x) Any limitations or restrictions on use required to prevent 
unreasonable adverse effects, such as:
    (A) Required intervals between application and harvest of food or 
feed crops.
    (B) Rotational crop restrictions.
    (C) Warnings as required against use on certain crops, animals, 
objects, or in or adjacent to certain areas.
    (D) For total release foggers as defined in paragraph (h)(2)(iii)(B) 
of this section, the following statements must be included in the 
``Directions for Use'':

    DO NOT use more than one fogger per room. DO NOT use in small, 
enclosed spaces such as closets, cabinets, or under counters or tables. 
Do not use in a room 5 ft. x 5 ft. or smaller; instead, allow fog to 
enter from other rooms. Turn off ALL ignition sources such as pilot 
lights (shut off gas valves), other open flames, or running electrical 
appliances that cycle off and on (i.e., refrigerators, thermostats, 
etc.). Call your gas utility or management company if you need 
assistance with your pilot lights.''
    (E) For restricted use pesticides, a statement that the pesticide 
may be applied under the direct supervision of a certified applicator 
who is not physically present at the site of application but nonetheless 
available to the person applying the pesticide, unless the Agency has 
determined that the pesticide may only be applied under the direct 
supervision of a certified applicator who is physically present.
    (F) Other pertinent information which the Administrator determines 
to be necessary for the protection of man and the environment.
    (j) Statement of Use Classification. By October 22, 1976, all 
pesticide products must bear on their labels a statement of use 
classification as described in paragraphs (j) (1) and (2) of this 
section. Any pesticide product for which 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

[[Page 62]]

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]

Subparts B-J [Reserved]



                 Subpart K--Worker Protection Statements

    Source: 57 FR 38146, Aug. 21, 1992, unless otherwise noted.



Sec. 156.200  Scope and applicability.

    (a) Scope. (1) This subpart prescribes statements that must be 
placed on the pesticide label and in pesticide labeling. These 
statements incorporate by reference the Worker Protection Standard, part 
170 of this chapter. The requirements addressed in these statements are 
designed to reduce the risk of illness or injury resulting from workers' 
and pesticide handlers' occupational exposures to pesticides used in the 
production of agricultural plants on agricultural establishments as 
defined in Sec. 170.3 of this chapter. These statements refer to 
specific workplace practices designed to reduce or eliminate exposure 
and to respond to emergencies that may arise from the exposures that may 
occur.
    (2) This subpart prescribes interim requirements that must be placed 
on the pesticide label and in pesticide labeling. These interim 
requirements pertain to restricted-entry intervals, personal protective 
equipment, and notification. On a case-by-case basis, these interim 
requirements will be reviewed and may be revised during reregistration 
or other agency review processes.
    (b) Applicability. (1) The requirements of this subpart apply to 
each pesticide product that bears directions for use in the production 
of any agricultural plant on any agricultural establishment as defined 
in Sec. 170.3 of this chapter, or whose labeling reasonably permits such 
use.
    (2) The requirements of this subpart do not apply to a product that 
bears directions solely for uses excepted by Sec. 170.202(b) of this 
chapter.
    (c) Effective dates. (1) The effective date of this subpart is 
October 20, 1992.
    (2) No pesticide product bearing labeling amended and revised as 
required by this subpart shall be distributed or sold by a registrant 
prior to April 21, 1993.
    (3) No product to which this subpart applies shall be distributed or 
sold without amended labeling by any registrant after April 21, 1994.
    (4) No product to which this subpart applies shall be distributed or 
sold without amended labeling by any person after October 23, 1995.



Sec. 156.203  Definitions.

    Terms in this subpart have the same meanings as they do in the 
Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In 
addition, the following terms, as used in this subpart, shall have the 
meanings stated below:
    Fumigant means any pesticide product that is a vapor or gas or forms 
a vapor or gas on application and whose method of pesticidal action is 
through the gaseous state.
    Restricted-entry interval means the time after the end of a 
pesticide application during which entry to the treated area is 
restricted.

[[Page 63]]



Sec. 156.204  Modification and waiver of requirements.

    (a) Modification on Special Review. If the Agency concludes in 
accordance with Sec. 154.25(c) of this chapter that a pesticide should 
be placed in Special Review because the pesticide meets or exceeds the 
criteria for human health effects of Sec. 154.7(a)(1)(2) or (6) of this 
chapter, the Agency may modify the personal protective equipment 
required for handlers or early-entry workers or both, the restricted-
entry intervals, or the notification to workers requirements.
    (b) Other modifications. The Agency, pursuant to this subpart and 
authorities granted in FIFRA sections 3, 6, and 12, may, on its 
initiative or based on data submitted by any person, modify or waive the 
requirements of this subpart, or permit or require alternative labeling 
statements. Supporting data may be either data required by Subdivisions 
U or K of the Pesticide Assessment Guidelines or data from medical, 
epidemiological, or health effects studies. The Pesticide Assessment 
Guidelines contain the standards for conducting acceptable tests, 
guidance on evaluation and reporting of data, definition of terms, 
further guidance on when data are required, and examples of acceptable 
protocols. They are available through the National Technical Information 
Service, 5285 Port Royal Rd., Springfield, VA 22161. A registrant who 
wishes to modify any of the statements required in Secs. 156.206, 
156.208, 156.210, or 156.212 must submit an application for amended 
registration unless specifically directed otherwise by the Agency.



Sec. 156.206  General statements.

    (a) Application restrictions. Each product shall bear the statement: 
``Do not apply this product in a way that will contact workers or other 
persons, either directly or through drift. Only protected handlers may 
be in the area during application.'' This statement shall be near the 
beginning of the DIRECTIONS FOR USE section of the labeling under the 
heading AGRICULTURAL USE REQUIREMENTS.
    (b) 40 CFR part 170 reference statement. (1) Each product shall bear 
the reference statement: ``Use this product only in accordance with its 
labeling and with the Worker Protection Standard, 40 CFR part 170.'' 
This statement shall be placed on the product label under the heading 
AGRICULTURAL USE REQUIREMENTS.
    (2) Each product shall bear the statement: ``This standard contains 
requirements for the protection of agricultural workers on farms, 
forests, nurseries, and greenhouses, and handlers of agricultural 
pesticides. It contains requirements for training, decontamination, 
notification, and emergency assistance. It also contains specific 
instructions and exceptions pertaining to the statements on this label 
[in this labeling] about [use any of the following that are applicable] 
personal protective equipment, restricted-entry interval, and 
notification to workers.'' These statements shall be placed immediately 
following the reference statement required by paragraph (b)(1) of this 
section, or they shall be placed in the supplemental product labeling 
under the heading AGRICULTURAL USE REQUIREMENTS.
    (3) If the statements in paragraph (b)(2) of this section are 
included in supplemental labeling rather than on the label of the 
pesticide container, the container label must contain this statement 
immediately following the statement required in paragraph (b)(1) of this 
section: ``Refer to supplemental labeling entitled AGRICULTURAL USE 
REQUIREMENTS in the DIRECTIONS FOR USE section of the labeling for 
information about this standard.''
    (4) If the statements in paragraph (b)(2) of this section are 
included in supplemental labeling, they must be preceded immediately by 
the statement in paragraph (b)(1) of this section under the heading 
AGRICULTURAL USE REQUIREMENTS in the labeling.
    (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

[[Page 64]]

the product name or product-type identification or shall be in the 
STATEMENT OF PRACTICAL TREATMENT or FIRST AID section of the label.
    (2) If the product is a fumigant, the label shall so state. The 
identification shall appear:
    (i) As part of the product name; or
    (ii) Close to the product name, as part of the product-type 
identification or as a separate phrase or sentence.
    (d) State restrictions. Each product shall bear the statement: ``For 
any requirements specific to your State, consult the agency in your 
State responsible for pesticide regulation.'' This statement shall be 
under the heading AGRICULTURAL USE REQUIREMENTS in the labeling.
    (e) Spanish warning statements. If the product is classified as 
toxicity category I or toxicity category II according to the criteria in 
Sec. 156.10(h)(1), the signal word shall appear in Spanish in addition 
to English followed by the statement, ``Si Usted no entiende la 
etiqueta, busque a alguien para que se la explique a Usted en detalle. 
(If you do not understand the label, find some one to explain it to you 
in detail.)'' The Spanish signal word ``PELIGRO'' shall be used for 
products in toxicity category I, and the Spanish signal word ``AVISO'' 
shall be used for products in toxicity category II. These statements 
shall appear on the label close to the English signal word.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]



Sec. 156.208  Restricted-entry statements.

    (a) Requirement. Each product with a restricted-entry interval shall 
bear the following statement: ``Do not enter or allow worker entry into 
treated areas during the restricted-entry interval (REI).'' This 
statement shall be under the heading AGRICULTURAL USE REQUIREMENTS in 
the labeling.
    (b) Location of specific restricted-entry interval statements. (1) 
If a product has one specific restricted-entry interval applicable to 
all registered uses of the product on agricultural plants, the 
restricted-entry interval for the product shall appear as a continuation 
of the statement required in paragraph (a) of this section and shall 
appear as follows: ``of X hours'' or ``of X days'' or ``until the 
acceptable exposure level of X ppm or mg/m3 is reached.''
    (2) If different restricted-entry intervals have been established 
for some crops or some uses of a product, the restricted-entry statement 
in paragraph (b)(1) of this section shall be associated on the labeling 
of the product with the directions for use for each crop each use to 
which it applies, immediately preceded or immediately followed by the 
words ``Restricted-entry interval'' (or the letters ``REI'').
    (c) Restricted-entry interval based on toxicity of active 
ingredient--(1) Determination of toxicity category. A restricted-entry 
interval shall be established based on the acute toxicity of the active 
ingredients in the product. For the purpose of setting the restricted-
entry interval, the toxicity category of each active ingredient in the 
product shall be determined by comparing the obtainable data on the 
acute dermal toxicity, eye irritation effects, and skin irritation 
effects of the ingredient to the criteria of Sec. 156.10(h)(1). The most 
toxic of the applicable toxicity categories that are obtainable for each 
active ingredient shall be used to determine the restricted-entry 
interval for that product. If no acute dermal toxicity data are 
obtainable, data on acute oral toxicity also shall be considered in this 
comparison. If no applicable acute toxicity data are obtainable on the 
active ingredient, the toxicity category corresponding to the signal 
word of any registered manufacturing-use product that is the source of 
the active ingredient in the end-use product shall be used. If no acute 
toxicity data are obtainable on the active ingredients and no toxicity 
category of a registered manufacturing-use product is obtainable, the 
toxicity category of the end-use product (corresponding to the signal 
word on its labeling) shall be used.
    (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 65]]

area where the average annual rainfall for the application site is less 
than 25 inches per year, the following statement shall be added to the 
restricted-entry interval statement: ``(72 hours in outdoor areas where 
average annual rainfall is less than 25 inches a year).''
    (ii) If the product contains only one active ingredient and it is in 
toxicity category II by the criteria in paragraph (c)(1) of this 
section, the restricted-entry interval shall be 24 hours.
    (iii) If the product contains only active ingredients that are in 
toxicity category III or IV by the criteria in paragraph (c)(1) of this 
section, the restricted-entry interval shall be 12 hours.
    (3) Restricted-entry interval for multiple active ingredient 
products. If the product contains more than one active ingredient, the 
restricted-entry interval (including any associated statement concerning 
use in arid areas under paragraph (c)(2)(i) of this section) shall be 
based on the active ingredient that requires the longest restricted-
entry interval as determined by the criteria in this section.
    (d) Exception for fumigants. The criteria for determining 
restricted-entry intervals in paragraph (c) of this section shall not 
apply to any product that is a fumigant. For fumigants, any existing 
restricted-entry interval (hours, days, or acceptable exposure level) 
shall be retained. Entry restrictions for fumigants have been or shall 
be established on a case-by-case basis at the time of registration, 
reregistration, or other Agency review process.
    (e) Existing product-specific restricted-entry intervals. (1) A 
product-specific restricted-entry interval, based on data collected in 
accordance with Sec. 158.390 of this chapter and Subdivision K of the 
Pesticide Assessment Guidelines, shall supersede any restricted-entry 
interval applicable to the product under paragraph (c) of this section.
    (2) Product-specific restricted-entry intervals established for 
pesticide products or pesticide uses that are not covered by part 170 of 
this chapter shall remain in effect and shall not be placed under the 
heading AGRICULTURAL USE REQUIREMENTS in the labeling.
    (f) Existing interim restricted-entry intervals. (1) An interim 
restricted-entry interval established by the Agency before the effective 
date of this subpart will continue to apply unless a longer restricted-
entry interval is required by paragraph (c) of this section.
    (2) Existing interim restricted-entry intervals established by the 
Agency for pesticide products or pesticide uses not covered by part 170 
of this chapter shall remain in effect and shall not be placed under the 
heading AGRICULTURAL USE REQUIREMENTS in the labeling.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]



Sec. 156.210  Notification-to-workers statements.

    (a) Requirement. Each product that meets the requirements of 
paragraph (b) of this section shall bear the posting and oral 
notification statements prescribed below. The statements shall be in the 
DIRECTIONS FOR USE section of the labeling under the heading 
AGRICULTURAL USE REQUIREMENTS.
    (b) Notification to workers of pesticide application. (1) Each 
product that contains any active ingredient classified as toxicity 
category I for either acute dermal toxicity or skin irritation potential 
under the criteria in Sec. 156.10(h)(1) shall bear the statement: 
``Notify workers of the application by warning them orally and by 
posting warning signs at entrances to treated areas.'' If no acute 
dermal toxicity data are obtainable, data on acute oral toxicity of the 
active ingredient shall be considered instead. If no data on acute 
dermal toxicity, skin irritation potential, or acute oral toxicity are 
obtainable on the active ingredient, the toxicity category corresponding 
to the signal word of any registered manufacturing-use product that is 
the source of the active ingredient in the end-use product shall be 
used. If none of the applicable acute toxicity data are obtainable on 
the active ingredient and no toxicity category of the registered 
manufacturing-use product is obtainable, the toxicity category of the 
end-use product corresponding to the product's signal word shall be 
used.
    (2) Each product that is a fumigant and is registered for use in a 
greenhouse (or whose labeling allows use in

[[Page 66]]

a greenhouse) shall bear the statement: ``For greenhouse applications, 
notify workers of the application by warning them orally and by posting 
warning signs outside all entrances to the greenhouse.''

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]



Sec. 156.212  Personal protective equipment statements.

    (a) Requirement. Each product shall bear the personal protective 
equipment statements prescribed in paragraphs (d) through (j) of this 
section.
    (b) Exceptions. (1) If personal protective equipment were required 
for a product before the effective date of this subpart, the existing 
requirements shall be retained on the labeling wherever they are more 
specific or more protective (as specified in EPA guidance materials) 
than the requirements in the table in paragraph (e) of this section.
    (2) Any existing labeling statement that prohibits the use of gloves 
or boots overrides the corresponding requirement in paragraph (e) of 
this section and must be retained on the labeling.
    (3) If the product labeling contains uses that are not covered by 
part 170 of this chapter, the registrant may adopt the personal 
protective equipment required in this section for those uses. However, 
if the personal protective equipment required in this section would not 
be sufficiently protective or would be onerously overprotective for uses 
not covered by part 170 of this chapter, the registrant must continue to 
apply the existing personal protective equipment requirements to those 
uses. The labeling must indicate which personal protective equipment 
requirements apply to uses covered by part 170 of this chapter and which 
personal protective equipment requirements apply to other uses.
    (c) Location of personal protective equipment statements--(1) 
Personal protective equipment statements for pesticide handlers. 
Personal protective equipment statements for pesticide handlers shall be 
in the HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) section of the labeling. 
The required statements may be combined to avoid redundancy as long as 
the requirements and conditions under which they apply are identified.
    (2) Personal protective equipment statements for early-entry 
workers. Personal protective equipment statements for early-entry 
workers shall be placed in the DIRECTIONS FOR USE section of the 
labeling under the heading AGRICULTURAL USE REQUIREMENTS and immediately 
after the restricted-entry statement required in Sec. 156.208(a).
    (d) Personal protective equipment statements for pesticide handlers. 
(1) The table in paragraph (e) of this section specifies minimum 
requirements for personal protective equipment (as defined in 
Sec. 170.240 of this chapter) and work clothing for pesticide handlers. 
This personal protective equipment requirement applies to any product 
that presents a hazard through any route of exposure identified in the 
table (acute dermal toxicity, skin irritation potential, acute 
inhalation toxicity, and eye irritation potential).
    (2) The requirement for personal protective equipment is based on 
the acute toxicity category of the end-use product for each route of 
exposure as defined by Sec. 156.10(h)(1). If data to determine the acute 
dermal toxicity or the acute inhalation toxicity are not obtainable, the 
acute oral toxicity shall be used as a surrogate to determine the 
personal protective equipment requirements for that route of exposure. 
If data to determine the acute toxicity of the product by a specific 
route of exposure (including acute oral toxicity in lieu of acute dermal 
or acute inhalation toxicity) are not obtainable, the toxicity category 
corresponding to the signal word of the end-use product shall be used to 
determine personal protective equipment requirements for that route of 
exposure. If the signal word is ``CAUTION,'' toxicity category III will 
be used.
    (3) The minimum personal protective equipment and work clothing 
requirements specified in this section shall be included in a statement 
such as the following: ``Applicators and other handlers must wear: (body 
protection statement); (glove statement, if applicable); (footwear 
statement, if applicable); (protective eyewear statement, if

[[Page 67]]

applicable); (respirator statement, if applicable).'' The format of 
statements given in this paragraph is optional, but it is recommended 
for clarity.
    (e) Summary of personal protective equipment requirements. The 
following table 1 summarizes the personal protective equipment 
requirements by route of exposure and toxicity category:

         Table 1--Minimum Personal Protective Equipment (PPE) and Work Clothing for Handling Activities
----------------------------------------------------------------------------------------------------------------
                                                       Toxicity Category of End-Use Product
        Route of Exposure        -------------------------------------------------------------------------------
                                           I                  II                  III                 IV
----------------------------------------------------------------------------------------------------------------
Dermal Toxicity or Skin           Coveralls worn      Coveralls worn      Long-sleeved shirt  Long-sleeved shirt
 Irritation Potential\1\           over long-sleeved   over short-         and long pants      and long pants
                                   shirt and long      sleeved shirt and
                                   pants               short pants
                                  Socks               Socks               Socks               Socks
                                  Chemical-resistant  Chemical-resistant  Shoes               Shoes
                                   footwear            footwear
                                  Chemical-resistant  Chemical-resistant  Chemical-resistant  No minimum\4\
                                   gloves\2\           gloves\2\           gloves\2\
 
Inhalation Toxicity               Respiratory         Respiratory         No minimum\4\       No minimum\4\
                                   protection          protection
                                   device\3\           device\3\
 
Eye Irritation Potential          Protective eyewear  Protective eyewear  No minimum\4\       No minimum\4\
----------------------------------------------------------------------------------------------------------------
\1\ If dermal toxicity and skin irritation potential are in different toxicity categories, protection shall be
  based on the more toxic (lower numbered) category.
\2\ For labeling language for chemical-resistant gloves, see paragraph (f) of this section.
\3\ For labeling language for respiratory protection device, see paragraphs (g) and (h) of this section.
\4\ Although no minimum PPE is required by this section for this toxicity category and route of exposure, the
  Agency may require PPE on a product-specific basis.

    (f) Chemical-resistant gloves labeling statements for pesticide 
handlers. If the table in paragraph (e) of this section indicates that 
chemical-resistant gloves are required, the glove statement shall be as 
specified in paragraph (f)(2), (3), (4), or (5) of this section.
    (1) Exception. The registrant shall specify a glove type other than 
that selected through the criteria in paragraphs (f)(2) through (5) of 
this section if information available to the registrant indicates that 
such a glove type is more appropriate or more protective than the glove 
type specified in this section. The statement must specify the 
particular types of chemical-resistant glove (such as nitrile, butyl, 
neoprene, and/or barrier-laminate).
    (2) Solid formulations. For products formulated and applied as 
solids or formulated as solids and diluted solely with water for 
application, the glove statement shall specify: ``waterproof gloves.''
    (3) Aqueous-based formulations. For products formulated and applied 
as a water-based liquid or formulated as a water-based liquid and 
diluted solely with water for application, the glove statement may 
specify: ``waterproof gloves'' instead of the statement in paragraph 
(f)(4) of this section.
    (4) Other liquid formulations. For products formulated or diluted 
with liquids other than water, the glove statement shall specify: 
``chemical-resistant (such as nitrile or butyl) gloves.''
    (5) Gaseous formulations and applications. For products formulated 
or applied as gases, any existing glove statement established before the 
effective date of this subpart, including any glove prohibition 
statement, will continue to apply. If no glove statement or glove 
prohibition now exists, the glove statement shall specify ``chemical-
resistant (such as nitrile or butyl) gloves.''
    (g) Existing respirator requirement for pesticide handlers on 
product labeling--(1) General requirement. If a statement placed on a 
product's labeling before the effective date of this subpart indicates 
that respiratory protection is required, that requirement for protection 
shall be retained. The statement must specify, or be amended to specify, 
one of the following respirator types and

[[Page 68]]

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--(1) General requirement. If the table in paragraph (e) of 
this section indicates a respiratory protection device is required, and 
existing product labeling

[[Page 69]]

has no respiratory protection requirement, the registrant shall add a 
respiratory protection statement that specifies a: ``dust/mist filtering 
respirator (MSHA/NIOSH approval number prefix TC-21C).''
    (2) Exception. The registrant shall specify a different type of 
respiratory protection device if information, such as vapor pressure 
value, is available to the registrant to indicate that the type of 
respiratory protection device required in paragraph (h)(1) of this 
section would not be adequately protective or might increase risks to 
the user unnecessarily.
    (i) Additional personal protective equipment requirements for 
pesticide handlers. In addition to the minimum personal protective 
equipment and work clothing requirements given in the table in paragraph 
(e) of this section, the labeling statement for any product in toxicity 
category I or II on the basis of dermal toxicity or skin irritation 
potential (or their surrogate as specified in paragraph (d)(2) of this 
section), shall include the following personal protective equipment 
instructions, additions, or substitutions as applicable:
    (1) If the product is not ready-to-use and there is no existing 
requirement for a chemical-resistant suit, the following statement shall 
be included: ``Mixers/Loaders: add a chemical-resistant apron.''
    (2) If the application of the product may result in overhead 
exposure to any handler (for example, applicator exposure during 
airblast spraying of orchards or flagger exposure during aerial 
application), the following statement shall be included: ``Overhead 
Exposure: wear chemical-resistant headgear.''
    (3) If any type of equipment other than the product container may be 
used to mix, load, or apply the product, and there is no requirement for 
a chemical-resistant protective suit, the following statement shall be 
included: ``For Cleaning Equipment: add a chemical-resistant apron.''
    (j) Personal protective equipment for early-entry workers. This 
paragraph specifies minimum requirements for personal protective 
equipment (as defined in Sec. 170.240 of this chapter) and work clothing 
for early-entry workers.
    (1) For all pesticide products, add the statement: ``For early entry 
to treated areas that is permitted under the Worker Protection Standard 
and that involves contact with anything that has been treated, such as 
plants, soil, or water, wear: (list the body protection, glove, 
footwear, protective eyewear, and protective headgear, if applicable, 
statements specified for applicators and other handlers, but omit any 
respiratory protection statement).''
    (2) If the body protection statement in the personal protective 
equipment requirement for handlers specifies a long-sleeved shirt and 
long pants, ``coveralls'' must be specified in the statement of personal 
protective equipment for early-entry workers.
    (3) If there is no statement requiring gloves and no prohibition 
against gloves for applicators and other handlers under the heading 
HAZARDS TO HUMANS (AND DOMESTIC ANIMALS) in the labeling, add a 
requirement for ``waterproof gloves'' in the statement of personal 
protective equipment for early-entry workers.

[57 FR 38146, Aug. 21, 1992, as amended at 58 FR 34203, June 23, 1993]



PART 157--PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES--Table of Contents




Subpart A [Reserved]

                  Subpart B--Child-Resistant Packaging

Sec.
157.20  General.
157.21  Definitions.
157.22  When required.
157.24  Exemptions.
157.27  Unit packaging.
157.30  Voluntary use of child-resistant packaging.
157.32  Standards.
157.34  Certification.
157.36  Recordkeeping.

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

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

Subpart A [Reserved]

[[Page 70]]



                  Subpart B--Child-Resistant Packaging



Sec. 157.20  General.

    This subpart prescribes requirements for child-resistant packaging 
of pesticide products and devices. The requirements are established 
under the authority of FIFRA section 25(a)(1), which authorizes the 
Administrator to issue regulations to carry out the purposes of the Act, 
and FIFRA section 25(c)(3), which authorizes the Administrator to 
establish standards with respect to the package, container or wrapping 
in which a pesticide or device is enclosed in order to protect children 
and adults from serious injury or illness resulting from accidental 
ingestion or contact with pesticides or devices regulated under the Act.



Sec. 157.21  Definitions.

    Terms used in this subpart shall have the following meanings:
    (a) Appropriate, when used with respect to child-resistant 
packaging, means that the packaging is chemically compatible with the 
pesticide contained therein.
    (b) Child-resistant packaging means packaging that is designed and 
constructed to be significantly difficult for children under 5 years of 
age to open or obtain a toxic or harmful amount of the substance 
contained therein within a reasonable time, and that is not difficult 
for normal adults to use properly.
    (c) Package or packaging means the immediate container or wrapping, 
including any attached closure(s), in which the pesticide is contained 
for distribution, sale, consumption, use or storage. The term does not 
include any shipping or bulk container used for transporting or 
delivering the pesticide unless it is the only such package.
    (d) Practicable, when used with respect to child-resistant 
packaging, means that the packaging can be mass produced and can be used 
in assembly line production.
    (e) Residential use means use of a pesticide or device:
    (1) Directly on humans or pets;
    (2) In, on, or around any structure, vehicle, article, surface or 
area associated with the household, including but not limited to areas 
such as non-agricultural outbuildings, non-commercial greenhouses, 
pleasure boats and recreational vehicles; or
    (3) In or around any preschool or day care facility.
    (f) Technically feasible, when applied to child-resistant packaging, 
means that the technology exists to produce the child-resistant 
packaging for a particular pesticide.
    (g) Unit packaging means a package that is labeled with directions 
to use the entire contents of the package in a single application.



Sec. 157.22  When required.

    Unless exempted under Sec. 157.24, a pesticide product must be 
distributed and sold in child-resistant packaging complying with 
Sec. 157.32 if it meets both of the following criteria:
    (a) Toxicity criterion. Based upon testing with an appropriate test 
species, the product meets any of the following toxicity criteria:
    (1) The pesticide has an acute oral LD50 of 1.5 g/kg or 
less;
    (2) The pesticide has an acute dermal LD50 of 2000 mg/kg 
or less;
    (3) The pesticide has an acute inhalation LC50 of 2 mg/
liter or less;
    (4) The pesticide is corrosive to the eye (causes irreversible 
destruction of ocular tissue) or causes corneal involvement or 
irritation persisting for 21 days or more;
    (5) The pesticide is corrosive to the skin (causes tissue 
destruction into the dermis and/or scarring) or causes severe skin 
irritation (severe erythema or edema) at 72 hours; or
    (6) The pesticide or device has such characteristics that, based 
upon human toxicological data, use history, accident data or such other 
evidence as is available, the Agency determines there is serious hazard 
of accidental injury or illness which child-resistant packaging could 
reduce; and
    (b) Use criterion. The product's labeling either directly recommends 
residential use or reasonably can be interpreted to permit residential 
use.



Sec. 157.24  Exemptions.

    (a) General exemptions. The Agency hereby exempts from the 
requirement

[[Page 71]]

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 an exemption 
will be issued in the Federal Register. In considering whether to grant 
an exemption, the Agency will

[[Page 72]]

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.



Sec. 157.34  Certification.

    (a) General. (1) The registrant of a pesticide product required to 
be in

[[Page 73]]

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 and 51 FR 36692, Oct. 15, 1986, as amended 
at 65 FR 39304, June 26, 2000]



PART 158--DATA REQUIREMENTS FOR REGISTRATION--Table of Contents




                      Subpart A--General Provisions

Sec.
158.20  Overview.
158.25  Applicability of data requirements.

[[Page 74]]

158.30  Timing of the imposition of data requirements.
158.32  Format of data submission.
158.33  Procedures for claims of confidentiality of data.
158.34  Flagging of studies for potential adverse effects.
158.35  Flexibility of the data requirements.
158.40  Consultation with the Agency.
158.45  Waivers.
158.50  Formulators' exemption.
158.55  Agricultural vs. non-agricultural pesticides.
158.60  Minor uses.
158.65  Biochemical and microbial pesticides.
158.70  Acceptable protocols.
158.75  Requirements for additional data.
158.80  Acceptability of data.
158.85  Revision of data requirements and guidelines.

                    Subpart B--How To Use Data Tables

158.100  How to determine registration data requirements.
158.101  Required vs. conditionally required data.
158.102  Distinguishing between what data are required and what 
          substance is to be tested.
158.108  Relationship of Pesticide Assessment Guidelines to data 
          requirements.

             Subpart C--Product Chemistry Data Requirements

158.150  General.
158.153  Definitions.
158.155  Product composition.
158.160  Description of materials used to produce the product.
158.162  Description of production process.
158.165  Description of formulation process.
158.167  Discussion of formation of impurities.
158.170  Preliminary analysis.
158.175  Certified limits.
158.180  Enforcement analytical method.
158.190  Physical and chemical characteristics.

                   Subpart D--Data Requirement Tables

158.202  Purposes of the registration data requirements.
158.240  Residue chemistry data requirements.
158.290  Environmental fate data requirements.
158.340  Toxicology data requirements.
158.390  Reentry protection data requirements.
158.440  Spray drift data requirements.
158.490  Wildlife and aquatic organisms data requirements.
158.540  Plant protection data requirements.
158.590  Nontarget insect data requirements.
158.640  Product performance data requirements.
158.690  Biochemical pesticides data requirements.
158.740  Microbial pesticides--Product analysis data requirements.

Appendix A to Part 158--Data Requirements for Registration: Use Pattern 
          Index.

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

    Source: 49 FR 42881, Oct. 24, 1984, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 158.20  Overview.

    (a) Legal authority. These requirements are promulgated under the 
authority of sections 3, 5, 12, and 25 of the Federal Insecticide, 
Fungicide and Rodenticide Act, as amended (FIFRA) (7 U.S.C. 136-136y).
    (b) Purposes of this part. (1) The primary purpose of this part is 
to specify the types and minimum amounts of data and information the 
Agency requires in order to make regulatory judgments about the risks 
and benefits of various kinds of pesticide products under the criteria 
set forth in FIFRA sections 3(c)(5) (C) and (D) and 3(c)(7).
    (2) This part also specifies the types and minimum amounts of data 
and information the Agency requires to decide whether to approve 
applications for experimental use permits under FIFRA section 5.
    (3) Finally, this part specifies the types and minimum amounts of 
data and information that an applicant for registration, amended 
registration, or reregistration must submit or cite in support of an 
application in order to satisfy the requirements of FIFRA section 
3(c)(1)(D) and sections 3(c)(5)(B) or 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

[[Page 75]]

evaluation, wildlife and aquatic organisms, plant protection, nontarget 
insects, product performance, and biochemical and microbial pesticides. 
The standards for conducting acceptable tests, guidance on evaluation 
and reporting of data, further guidance on when data are required, 
definition of most terms, and examples of protocols are not specified in 
this part. This information is available in advisory documents 
(collectively referred to as Pesticide Assessment Guidelines) through 
the National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161 (telephone: 703-487-4650).



Sec. 158.25  Applicability of data requirements.

    (a) Some kinds of data and information are specified in subparts C 
and D of this part as ``required'' (``R'') for the evaluation of some or 
all types of products. Other kinds of data and information are specified 
in those sections as ``conditionally required'' (``CR''), that is, they 
are required if the product's proposed pattern of use, results of other 
tests, or other pertinent factors meet the criteria specified in those 
sections. The terms ``required'' and ``conditionally required'' are 
further discussed in Secs. 158.100 and 158.101.
    (b) The Agency recognizes that certain data requirements may not be 
applicable to (or should be waived for) some products, and has made 
provisions for such cases in this part as specified in Sec. 158.35 
Flexibility of the data requirements, Sec. 158.40 Consultation with the 
Agency, Sec. 158.45 Waivers, and Sec. 158.60 Minor uses.

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



Sec. 158.30  Timing of the imposition of data requirements.

    This part establishes requirements for the types of data which are 
necessary to support the unconditional registration of a pesticide 
product under section 3(c)(5) of the Act. While every registered 
pesticide product must eventually be supported by the data required by 
part 158, when an applicant or registrant must initially satisfy these 
data requirements depends on the factors listed below in this section.
    (a) Existing Registrations. A registrant of a currently registered 
pesticide product is not obligated to satisfy any data requirement in 
part 158 with respect to that product until he receives a notice under 
section 3(c)(2)(B) of the Act that additional data are required to 
support the continued registration of the product, until he applies for 
an amendment to the registration, or until the product is subject to 
reregistration.
    (b) Applications. The amount of data required by the Agency to 
evaluate an application for initial or amended registration depends on 
whether the product is being reviewed under section 3(c)(5) of the Act 
(unconditional registration) or section 3(c)(7) of the Act (conditional 
registration). Refer to Sec. 152.111 of this chapter or consult with the 
appropriate EPA Product Manager to determine under which section of the 
Act the application will be reviewed. The following paragraphs identify, 
for each different type of application, the minimum amount of data that 
must be available for EPA review to permit EPA to make the statutory 
risk-benefit determinations required by section 3(c)(5) or 3(c)(7) of 
the Act. In addition to satisfying these minimum data requirements, 
applicants may be required to submit or cite additional data, either to 
permit EPA to assess the safety or efficacy of the product (refer to 
Sec. 158.75) or to comply with the statutory requirements of section 
3(c)(1)(D) of the Act, or both.
    (1) Applications for unconditional registration under section 
3(c)(5) of the Act. EPA will not approve an application for 
unconditional registration unless all data required by this part which 
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

[[Page 76]]

applicant has not had sufficient time to produce the data.
    (3) Applications for conditional registration of products which are 
identical or substantially similar to currently registered products 
under section 3(c)(7)(A) of the Act. EPA will not approve an application 
for conditional registration of a pecticide product which is identical 
or substantially similar to a currently registered pesticide unless the 
following data are available for EPA to review:
    (i) Product chemistry data, as required by subpart C of this part.
    (ii) Product performance data, to the extent required by 
Sec. 158.160.
    (4) Applications for conditional registration of new uses of 
currently registered products under section 3(c)(7)(B) of the Act. EPA 
will not approve an application for registration of a pesticide for a 
new use of a currently registered pesticide product unless the following 
data are available for EPA to review:
    (i) Product chemistry data, as required by subpart C of this part.
    (ii) Product performance data, to the extent required by 
Sec. 158.160.
    (iii) Other data pertaining solely to the new use. The applicant may 
generally determine which data pertain solely to the new use by 
comparing the data requirements for all existing uses of all currently 
registered products containing the same active ingredient(s) with those 
for all uses including the new use. Any differences are attributable to 
the new use and must be submitted with the application.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 
FR 34203, June 23, 1993]



Sec. 158.32  Format of data submission.

    (a) Transmittal document. All data submitted at the same time and 
for review in support of a single administrative action (e.g., an 
application for registration, reregistration, experimental use permit, 
or in response to a requirement for data under the authority of FIFRA 
sec. 3(c)(2)(B), must be accompanied by a single transmittal document 
including the following information:
    (1) The identity of the submitter, or the identity of each joint 
submitter and of the agent for joint submitters;
    (2) The date of the submission;
    (3) The identification of the Agency action in support of which the 
data are being submitted, such as the registration number or file 
symbol, petition number, experimental use permit number, or registration 
standard review; and
    (4) A bibliography of all specific documents included in the 
submission and covered by the transmittal.
    (b) Individual studies. (1) All data must be submitted in the form 
of individual studies. Unless otherwise specified by the Agency, each 
study should address a single data requirement, and be listed separately 
in the bibliography.
    (2) Each study must include the following elements in addition to 
the study itself:
    (i) A title page, as described in paragraph (c) of this section;
    (ii) A Statement of Data Confidentiality Claims and, if desired, a 
Supplemental Statement of Data Confidentiality Claims, in accordance 
with Sec. 158.33;
    (iii) A certification with respect to Good Laboratory Practice 
standards, if required by Sec. 160.12 of this chapter;
    (iv) If the original study is not in the English language, a 
complete and accurate English translation under the same cover; and
    (v) If the study is of a type listed in Sec. 158.34(b), the 
statement prescribed by paragraph (c) of that section.
    (3) Three identical copies of each study must be submitted. If the 
study is submitted in conjunction with a pending Special Review or 
Registration Standard under development, four copies must be submitted. 
Three copies must be identical and must conform to the requirements of 
Sec. 158.33 with respect to claims of confidentiality. The fourth copy 
will be placed in the public docket and must conform to the requirements 
of Sec. 154.15(c) of this chapter or Sec. 155.30(c) of this chapter with 
respect to claimed confidential business information.
    (4) All copies must be in black ink on uniform pages of white, 8\1/
2\  x  11 inch paper. Copies must have high contrast and good resolution 
for microfilming. Frayed or oversize pages and glued bindings are not 
acceptable.

[[Page 77]]

    (c) Contents of title page. Each individual study must have a title 
page bearing the following identifying information:
    (1) The title of the study, including identification of the 
substance(s) tested and the test name or data requirement addressed;
    (2) The author(s) of the study;
    (3) The date the study was completed;
    (4) If the study was performed in a laboratory, the name and address 
of the laboratory and any laboratory project numbers or other 
identifying codes;
    (5) If the study is a commentary on or supplement to another 
previously submitted study, full identification of the other study with 
which it should be associated in review; and
    (6) If the study is a reprint of a published document, all relevant 
facts of publication, such as the journal title, volume, issue, 
inclusive page numbers, and date of publication.
    (d) EPA identification number. EPA will assign each study an EPA 
Master Record Identification (MRID) number, and will promptly notify the 
submitter of the number assigned. This number should be used in all 
further communications with the Agency about the study.
    (e) Reference to previously submitted data. Data which previously 
have been submitted need not be resubmitted unless resubmission is 
specifically requested by the Agency. If an applicant or registrant 
wishes the Agency to consider such data in the review of an Agency 
action, he should cite the data by providing:
    (1) The title or adequate description of the study;
    (2) The transmittal information required by paragraph (a) (1), (2), 
and (3) of this section; and
    (3) The MRID number assigned in accordance with paragraph (d) of 
this section.

[53 FR 15991, May 4, 1988]



Sec. 158.33  Procedures for claims of confidentiality of data.

    (a) General. A data submitter must clearly identify any information 
which he claims is entitled to confidential treatment under FIFRA sec. 
10. The procedures in this section must be followed to assert a claim of 
confidentiality.
    (b) Claims of confidentiality for information described by FIFRA 
sec. 10(d)(1) (A), (B), and (C). Any information claimed to be 
confidential under FIFRA sec. 10(d)(1) (A) through (C) must be submitted 
in accordance with the following procedures:
    (1) The information must be contained in a separate attachment to 
the study. If any information is included in the body of the study 
rather than in the confidential attachment, the submitter waives a claim 
of confidentiality for such information under FIFRA sec. 10(d)(1) (A), 
(B), or (C).
    (2) The attachment must have a cover page which is clearly marked to 
indicate that the material contained in the attachment falls within the 
scope of FIFRA sec. 10(d)(1) (A), (B), or (C).
    (3) Each item in the attachment must be numbered. For each item, the 
submitter must cite the applicable portion of FIFRA sec. 10(d)(1) (A), 
(B), or (C) on which the claim of confidentiality is based. In addition, 
for each item, the submitter must provide a list of page numbers in the 
study where the item is cited (i.e., identified by number).
    (4) Each item in the attachment must be referenced in the body of 
the study by its number in the attachment.
    (5) The following statement must appear on the Statement of Data 
Confidentiality Claims:

    Information claimed confidential on the basis of its falling within 
the scope of FIFRA sec. 10(d)(1)(A), (B), or (C) has been removed to a 
confidential appendix, and is cited by cross-reference number in the 
body of the study.


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:


[[Page 78]]


    No claim of confidentiality is made for any information contained in 
this study on the basis of its falling within the scope of FIFRA sec. 
10(d)(1)(A), (B), or (C).


This statement must bear the name, title and signature of the submitter 
or his properly designated agent, and the date of signature.
    (d) Claim of confidentiality for information not described by FIFRA 
sec. 10(d)(1) (A), (B), or (C). Any information not described by FIFRA 
sec. 10(d)(1) (A), (B), or (C) for which a claim of confidentiality is 
made must be submitted in accordance with the following procedures:
    (1) The information must be clearly marked in the body of the study 
as being claimed confidential.
    (2) A separate Supplemental Statement of Data Confidentiality Claims 
must be submitted identifying by page and line number the location 
within the study of each item claimed confidential, and stating the 
basis for the claim.
    (3) The Supplemental Statement of Data Confidentiality Claims must 
bear the name, title, and signature of the submitter or his properly 
designated agent, and the date of signature.

[53 FR 15991, May 4, 1988]



Sec. 158.34  Flagging of studies for potential adverse effects.

    (a) Any person who submits a study of a type listed in paragraph (b) 
of this section to support an application for new or amended 
registration, or to satisfy a requirement imposed under FIFRA sec. 
3(c)(2)(B), must submit with the study a statement in accordance with 
paragraph (c) of this section.
    (b) The following table indicates that study types and the criteria 
to be applied to each. Column 1 lists the study types by name. Column 2 
lists the associated Pesticide Assessment Guideline number. Column 3 
lists the criteria applicable to each type of study. Column 4 lists the 
reporting code to be included in the statement specified in 
Sec. 158.34(c) when any criterion is met or exceeded.

                                            Table--Flagging Criteria
----------------------------------------------------------------------------------------------------------------
                                            Pesticide
                                            assessment                                                Reporting
             Toxicity studies               guidelines                    Criteria                       code
                                               No.
----------------------------------------------------------------------------------------------------------------
Oncogenicity [or combined oncogenicity/           83-2  Treated animals show any of the following:
 chronic feeding study]
      or
Subchronic feeding study.................         82-1  An incidence of neoplasms in male or female            1
                                                         animals which increases with dose;
                                                                  or
                                                        A statistically significant (p 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

[[Page 79]]

 
                                                        General (systemic) toxicity NOEL less than             8
                                                         100 times the current existing ADI.
 
----------------------------------------------------------------------------------------------------------------
Reproduction study.......................         83-4  Reproductive effects NOEL less than 100                9
                                                         times the current ADI.
 
----------------------------------------------------------------------------------------------------------------
Subchronic feeding study.................         82-1  Cholinesterase inhibition NOEL less than              10
                                                         100 times the current existing ADI.
                                                                  or
                                                        General (systemic) toxicity NOEL less than            11
                                                         1000 times the current existing ADI.
----------------------------------------------------------------------------------------------------------------

    (c) Identification of studies. For each study of a type identified 
in paragraph (b) of this section, the applicant (or registrant in the 
case of information submitted under FIFRA sec. 3(c)(2)(B)) shall include 
the appropriate one of the following two statements, together with the 
signature of the authorized representative of the company, and the date 
of signature:
    (1) ``I have applied the criteria of 40 CFR 158.34 for flagging 
studies for potential adverse effects to the results of the attached 
study. This study neither meets nor exceeds any of the applicable 
criteria.''
    (2) ``I have applied the criteria of 40 CFR 158.34 for flagging 
studies for potential adverse effects to the results of the attached 
study. This study meets or exceeds the criteria numbered [insert all 
applicable reporting codes.]''

[53 FR 15992, May 4, 1988, as amended at 58 FR 34203, June 23, 1993]



Sec. 158.35  Flexibility of the data requirements.

    Several provisions of this part provide EPA flexibility in requiring 
(or not requiring) data and information for the purposes specified in 
Sec. 158.20(b). These provisions are summarized in this section and 
discussed elsewhere in this part.
    (a) The Agency encourages each applicant, particularly a person 
applying for registration for the first time, to consult with the 
Product Manager for his product to resolve questions relating to the 
protocols or the data requirements before undertaking extensive testing 
under Sec. 158.40.
    (b) Any applicant who believes that a data requirement is 
inapplicable to a specific pesticide product may request a waiver of a 
data requirement under Sec. 158.45.
    (c) The Agency may require an applicant to provide additional data 
or information beyond that specified in subparts C and D of this part 
when these data are not sufficient to permit EPA to evaluate the 
applicant's product under Sec. 158.75.
    (d) Several policies are in effect that govern the data requirements 
for registration of products having minor uses. These policies reduce 
substantially the data requirements that need to be met on the basis of 
limited exposures and economic equity, and allow case-by-case decision 
making to determine the specific needs for each kind of use under 
Sec. 158.60.
    (e) The data requirements and guidelines are not static documents. 
Section 3(c)(2) of FIFRA states that the administrator ``shall revise 
such guidelines from time to time.'' Therefore, the data requirements 
and guidelines will be revised periodically to reflect new scientific 
knowledge, new trends in pesticide development, and new Agency policies 
under Sec. 158.80.

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



Sec. 158.40  Consultation with the Agency.

    This part establishes data requirements applicable to various 
general use patterns of pesticide products, but some unique or 
unanticipated aspect of a proposed product's use pattern or composition 
may result in the need for

[[Page 80]]

conferences between registration applicants and the Agency. Such 
conferences may be initiated by the Agency or by registration 
applicants. Applicants are expected to contact their respective Product 
Managers to arrange discussions. The Agency welcomes suggestions for 
changes to improve the clarity, accuracy, or some other aspect of the 
data requirements set forth in this part. Specific suggestions should be 
forwarded to the Director of the Hazard Evaluation Division.



Sec. 158.45  Waivers.

    (a) Rationale and policy. (1) The data requirements specified in 
this part as applicable to a category of products will not always be 
appropriate for every product in that category. Some products may have 
unusual physical, chemical, or biological properties or atypical use 
patterns which would make particular data requirements inappropriate, 
either because it would not be possible to generate the required data or 
because the data would not be useful in the Agency's evaluation of the 
risks or benefits of the product. The Agency will waive data 
requirements it finds are inappropriate, but will ensure that sufficient 
data are available to make the determinations required by the applicable 
statutory standards.
    (2) The Agency will waive data requirements on a case-by-case basis 
in response to specific written requests by applicants. Because of the 
wide variety of types and use patterns of pesticides, it is impossible 
to spell out all of the circumstances which might serve as a basis for 
waiving data requirements. The Agency, however, will take into account, 
as appropriate, the factors enumerated in sections 3(c)(2)(A) and 
25(a)(1) of FIFRA.
    (b) Procedure for requesting waiver. (1) An applicant should discuss 
his plans to request a waiver with the EPA Product Manager responsible 
for his product before developing and submitting extensive support 
information for the request.
    (2) To request a waiver, an applicant must submit a written request 
to the appropriate Product Manager. The request must specifically 
identify the data requirement for which a waiver is requested, explain 
why he thinks data requirement(s) should be waived, describe any 
unsuccessful attempts to generate the required data, furnish any other 
information which he believes would support the request, and when 
appropriate, suggest alternative means of obtaining data to address the 
concern which underlies the data requirement.
    (c) Notification of waiver decision. The Agency will review each 
waiver request and inform the applicant in writing of its decision. In 
addition, for decisions that could apply to more than a specific 
product, the Agency may choose to send a notice to all registrants or to 
publish a notice in the Federal Register announcing its decision. An 
Agency decision denying a written request to waive a data requirement 
shall constitute final Agency action for purposes of FIFRA section 
16(a).
    (d) Availability of waiver decisions. Agency decisions under this 
section granting waiver requests will be available to the public at the 
Office of Pesticide Programs Reading Room, Rm. 236, Crystal Mall 2, 
1921 Jefferson Davis Highway, Arlington, VA 22202 from 8:00 a.m. to 4:00 
p.m., Monday through Friday, except legal holidays. Any person may 
obtain a copy of any waiver decision by written request in the manner 
set forth in 40 CFR part 2.



Sec. 158.50  Formulators' exemption.

    (a) FIFRA section 3(c)(2)(D) provides that an applicant for 
registration of an end-use pesticide product need not submit or cite any 
data that pertain to the safety of another registered pesticide product 
which is purchased by the applicant and used in the manufacture or 
formulation of the product for which registration is sought.
    (b) This exemption applies only to data concerning safety of a 
product or its ingredients, not to efficacy data. Data concerning safety 
includes toxicity, metabolism, environmental fate, product chemistry, 
and residue chemistry data.
    (c) This exemption does not apply to data concerning the safety of 
the applicant's end-use product itself, unless the composition of the 
applicant's product and that of the purchased product are

[[Page 81]]

identical, i.e., data which this part indicates must be developed by 
tests using the end-use product for which registration is sought as the 
test substance. These requirements can be identified by the notation 
``EP*'' in the ``test substance'' column of the tables in subparts C and 
D of this part and these are the minimum data requirements that the 
applicant described in paragraph (a) of this section (i.e., the 
``formulator'') must satisfy.
    (d) The data to which this exemption applies usually will concern 
the safety of one or more of the end-use product's active ingredients, 
specifically, those active ingredients which are contained in the 
purchased product. These data requirements normally can be identified by 
the notations ``TGAI'' (technical grade of active ingredient), ``PAI'' 
(pure active ingredients), ``PAIRA'' (pure active ingredient, 
radiolabeled), or ``TEP'' (typical end-use product) in the ``test 
substance'' column of the tables in subparts C and D of this part.
    (e) EPA interprets FIFRA section 3(c)(2)(D) as allowing an applicant 
to use the formulator's exemption with respect to a data requirement 
concerning the safety of an ingredient of his product only if:
    (1) His application indicates that the ingredient's presence in his 
product is attributable solely to his purchase from another person of an 
identified, registered product containing that ingredient and his use of 
the purchased product in formulating his product; and
    (2) The purchased product is a registered manufacturing-use product 
whose label does not prohibit its use for making an end-use product with 
any use for which the applicant's product will be labeled; or
    (3) The purchased end-use product is a registered end-use product 
labeled for each use for which the applicant's product will be labeled.
    (f) Notwithstanding FIFRA section 3(c)(2)(D), EPA will not approve 
an application unless there is available to EPA for its review whatever 
data is necessary in order to make the required risk/benefit finding 
under FIFRA section 3(c)(5) or section 3(c)(7).

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



Sec. 158.55  Agricultural vs. non-agricultural pesticides.

    Section 25(a)(1) of FIFRA instructs the Administrator to ``take into 
account the difference in concept and usage between various classes of 
pesticides and differences in environmental risk and the appropriate 
data for evaluating such risk between agricultural and non-agricultural 
pesticides.'' This part distinguishes the various classes of pesticide 
use (e.g., crop vs. non-crop) and the corresponding data necessary to 
support registration under FIFRA. This information is present in each 
data requirement table. In addition, the Use Pattern Index (appendix A) 
is a comprehensive list of pesticide use patterns, cross-referenced to 
the general use patterns appearing in the tables; the index will further 
assist the reader in distinguishing agricultural versus non-agricultural 
uses of pesticides.

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



Sec. 158.60  Minor uses.

    (a) Minor use policy. A minor use of a pesticide is a use on a 
``minor crop'' (a crop which is planted on a small total amount of 
acreage) or a use which is otherwise limited such that the potential 
market volume of the product for that use is inherently small. EPA's 
policy concerning data requirements for minor uses of pesticides 
includes the following elements:
    (1) Since the market volume for a minor use of a pesticide is 
intrinsically 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.

[[Page 82]]

    (3) EPA will accept extrapolations and regional data to support 
establishment of individual minor use tolerances.
    (4) Group tolerances will be established to assist applicants for 
registration of products for minor uses as described in 40 CFR 180.34.
    (b) Advice on data requirements to support minor uses. Applicants 
for registration are advised to contact the appropriate EPA Product 
Manager of the Minor Use Officer for advice on developing data to 
support new applications for minor uses of pesticides.



Sec. 158.65  Biochemical and microbial pesticides.

    Biochemical and microbial pesticides are generally distinguished 
from conventional chemical pesticides by their unique modes of action, 
low use volume, target species specificity or natural occurrence. In 
addition, microbial pesticides are living entities capable of survival, 
growth reproduction and infection. Biochemical and microbial pesticides 
are subject to a different set of data requirements, as specified in 
Secs. 158.165 and 158.170, respectively.
    (a) Biochemical pesticides. Biochemical pesticides include, but are 
not limited to, products such as semichemicals (e.g. insect pheromones), 
hormones (e.g., insect juvenile growth hormones), natural plant and 
insect regulators, and enzymes. When necessary the Agency will evaluate 
products on an individual basis to determine whether they are 
biochemical or conventional chemical pesticides.
    (b) Microbial pesticides. (1) Microbial pesticides include microbial 
entities such as bacteria, fungi, viruses, and protozoans. The data 
requirements apply to all microbial pesticides, including those that are 
naturally-occurring as well as those that are genetically modified. Each 
``new'' variety, subspecies, or strain of an already registered 
microbial pest control agent must be evaluated, and may be subject to 
additional data requirements.
    (2) Novel microbial pesticides (i.e., genetically modified or non-
indigenous microbial pesticides) will be subject to additional data or 
information requirements on a case-by-case basis depending on the 
particular micro-organism, its parent microorganism, the proposed 
pesticide use pattern, and the manner and extent to which the organism 
has been genetically modified. Additional requirements may include 
information on the genetic engineering techniques used, the identity of 
the inserted or deleted gene segment (base sequence data or enzyme 
restriction map of the gene), information on the control region of the 
gene in question, a description of the ``new'' traits or characteristics 
that are intended to be expressed, tests to evaluate genetic stability 
and exchange, and/or selected Tier II environmental expression and 
toxicology tests.
    (3) Pest control organisms such as insect predators, nematodes, and 
macroscopic parasites are exempt from the requirements of FIFRA as 
authorized by section 25(b) of FIFRA and specified in Sec. 152.20 (a) of 
this chapter.

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



Sec. 158.70  Acceptable protocols.

    The Agency has published Pesticide Assessment Guidelines, as 
indicated in Sec. 158.20(d), which contain suggested protocols for 
conducting tests to develop the data required by this part.
    (a) General policy. Any appropriate protocol may be used provided 
that it meets the purpose of the test standards specified in the 
guidelines and provides data of suitable quality and completeness as 
typified by the protocols cited in the guidelines. Applicants should use 
the test procedure which is most suitable for evaluation of the 
particular ingredient, mixture, or product. Accordingly, failure to 
follow a suggested protocol will not invalidate a test if another 
appropriate methodology is used.
    (b) Organization for Economic Cooperation and Development (OECD) 
Protocols. Tests conducted in accordance with the requirements and 
recommendations of the applicable OECD protocols can be used to develop 
data necessary to meet the requirements specified in this part. Readers 
should note, however, that certain of the OECD recommended test 
standards, such as test duration and selection of test species, are less 
restrictive than those recommended by EPA. Therefore, when using the 
OECD protocols, care should be taken to observe

[[Page 83]]

the test standards in a manner such that the data generated by the study 
will satisfy the requirements of this part.
    (c) Procedures for requesting advice on protocols. Normally, all 
contact between the Agency and applicants or registrants is handled by 
the assigned Product Manager in the Registration Division of the Office 
of Pesticide Programs. Accordingly, questions concerning protocols 
should be directed, preferably in writing, to the Product Manager 
responsible for the registration or application which would be affected.



Sec. 158.75  Requirements for additional data.

    (a) General policy. The data routinely required by part 158 may not 
be sufficient to permit EPA to evaluate every pesticide product. If the 
information required under this part is not sufficient to evaluate the 
potential of the product to cause unreasonable adverse effects on man or 
the environment, additional data requirements will be imposed. However, 
EPA expects that the information required by this part will be adequate 
in most cases for an assessment of the properties of pesticide.
    (b) Policy on test substance. In general, where the technical grade 
of the active ingredient is specified as the substance to be tested, 
tests may be performed using a technical grade which is substantially 
similar to the technical grade used in the product for which 
registration is sought. In addition to or in lieu of the testing 
required in subparts C and D of this part the Administrator will, on a 
case-by-case basis, require testing to be conducted with:
    (1) An analytical pure grade of an active ingredient, with or 
without radioactive tagging.
    (2) The technical grade of an active ingredient.
    (3) The representative technical grade of an active ingredient.
    (4) An intentionally added inert ingredient in a pesticide product.
    (5) A contaminant or impurity of an active or inert ingredient.
    (6) A plant or animal metabolite or degradation product of an active 
or inert ingredient.
    (7) The end-use pesticide product.
    (8) The end-use pesticide product plus any recommended vehicles and 
adjuvants.
    (9) Any additional substance which could act as a synergist to the 
product for which registration is sought.
    (10) Any combination of substances in paragraphs (b) (1) through (9) 
of this section.

[49 FR 42881, Oct. 24, 1984, as amended at 53 FR 15999, May 4, 1988; 58 
FR 34203, June 23, 1993]



Sec. 158.80  Acceptability of data.

    (a) General policy. The Agency will determine whether the data 
submitted to fulfill the data requirements specified in this part are 
acceptable. This determination will be based on the design and conduct 
of the experiment from which the data were derived, and an evaluation of 
whether the data fulfill the purpose(s) of the data requirement. In 
evaluating experimental design, the Agency will consider whether 
generally accepted methods were used, sufficient numbers of measurements 
were made to achieve statistical reliability, and sufficient controls 
were built into all phases of the experiment. The Agency will evaluate 
the conduct of each experiment in terms of whether the study was 
conducted in conformance with the design, good laboratory practices were 
observed, and results were reproducible. The Agency will not reject data 
merely because they were derived from studies which, when initiated were 
in accordance with an Agency-recommended protocol, even if the Agency 
subsequently recommends a different protocol, as long as the data 
fulfill the purposes of the requirements as described in this paragraph.
    (b) Previously developed data. The Agency will consider that data 
developed prior to the effective date of this part would be satisfactory 
to support applications provided good laboratory practices were 
followed, the data meet the purposes of this part, and the data permit 
sound scientific judgments to be made. Such data will not be rejected 
merely because they were not developed in accordance with suggested 
protocols.
    (c) Data developed in foreign countries. The Agency considers all 
applicable data developed from laboratory and

[[Page 84]]

field studies anywhere to be suitable to support pesticide registrations 
except for data from tests which involved field test sites or a test 
material, such as a native soil, plant, or animal, that is not 
characteristic of the United States. When studies at test sites or with 
materials of this type are anticipated, applicants should take steps to 
assure that United States materials are used or be prepared to supply 
data or information to demonstrate the lack of substantial or relevant 
differences between the selected material or test site and the United 
States material or test site. Once comparability has been established, 
the Agency will assess the acceptability of the data as described in 
paragraph (a) of this section.
    (d) Data from monitoring studies. Certain data are developed to meet 
the monitoring requirements of FIFRA sections 5, 8 or 20. Applicants may 
wish to determine whether some of these data may meet the requirements 
of this part. In addition, data developed independently of FIFRA 
regulations or requirements may also satisfy data requirements in this 
part. Consultation with appropriate EPA Product Managers would be 
helpful if applicants are unsure about suitability of such data.



Sec. 158.85  Revision of data requirements and guidelines.

    (a) Data requirements will be revised from time to time to keep up 
with policy changes and technology. Revisions to this part will be made 
in accordance with the Administrative Procedure Act (5 U.S.C. 551 et 
seq.). Changes having a significant impact on the registration process, 
applicants, testers, or other parties, or on the outcome and evaluation 
of studies, will be made only after public notice and opportunity for 
comment. Until final rules reflecting a change have been promulgated, 
the Agency can implement changes in the data requirements on a case-by-
case basis.
    (b) The Agency invites registration applicants, registrants, and the 
general public to suggest changes in the data requirements or the 
Pesticide Assessment Guidelines. Suggestions may be submitted at any 
time. Those making suggestions are requested to contact, in writing, the 
Director of the Hazard Evaluation Division. When suggestions consist of 
new suggested methods, representative test results should accompany the 
submittals.



                    Subpart B--How To Use Data Tables



Sec. 158.100  How to determine registration data requirements.

    To determine the specific kinds of data needed to support the 
registration of each pesticide product, the registration applicant 
should:
    (a) Refer to subparts C and D (Secs. 158.150 through 158.740). These 
subparts describe the data requirements, including data tables for each 
subject area. The corresponding subdivisions in the Pesticide Assessment 
Guidelines are listed in Sec. 158.108.
    (b) Select the general use pattern(s) that best covers the use 
pattern(s) specified on the pesticide product label. Selection of the 
appropriate general use pattern(s) will usually be obvious. However, 
unique or ambiguous cases will arise occasionally. These situations may 
be clarified by reference to the Use Pattern Index presented in the 
appendix to the Data Requirements for Registration. The applicant can 
look up a specific use pattern in appendix A and it will be cross 
referenced to the appropriate general use patterns to be used in each 
Data Requirement table.
    (c) Proceed down the appropriate general use pattern column in the 
table and note which tests (listed along the left hand side of the 
table) are required (``R''), conditionally required (``CR'') or usually 
not required (``--''). After reading through each data requirement 
table, the applicant will have a complete list of required and 
conditionally required data for the pesticide product 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]

[[Page 85]]



Sec. 158.101  Required vs. conditionally required data.

    (a) Data designated as ``required'' (``R'') for products with a 
given general use pattern are needed by EPA to evaluate the risks or 
benefits of a product having that use pattern unless the data 
requirement has been waived under Sec. 158.45 for that particular 
product or unless the product is covered by a specific exception set 
forth in a note accompanying the requirement.
    (b) Data designated as ``conditionally required'' (``CR'') for 
products with a given general use pattern are needed by EPA to evaluate 
the risks or benefits of a product having that use pattern if the 
product meets the conditions specified in the corresponding notes 
accompanying the data requirements table. As indicated in the notes, the 
determination of whether the data must be submitted is based on the 
product's use pattern, physical or chemical properties, expected 
exposure of nontarget organisms, and/or results of previous testing 
(e.g., tier testing). Applicants must evaluate each applicable note to 
determine whether or not conditionally required data must be submitted 
as indicated by the conditions and criteria specified in the 
accompanying notes unless the Agency has granted a waiver request 
submitted by the registrant in accordance with Sec. 158.45.
    (c) For certain of the required or conditionally required data, the 
``R'' or ``CR'' designations and are enclosed in brackets (i.e., [R], 
[CR]). The brackets designate those data that are required or 
conditionally required to support a product when an experimental use 
permit is being sought. In all other situations (i.e., other than 
support of an experimental use permit), the brackets have no meaning and 
the designations R and CR are equivalent to [R] and [CR], respectively.

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



Sec. 158.102  Distinguishing between what data are required and what substance is to be tested.

    (a) Readers should be careful to distinguish between what data are 
required and what substance is to be tested, as specified in this part 
and in each corresponding section of the guidelines. Each data 
requirement table specifies whether a particular data requirement is 
required to support the registration of manufacturing-use products, end-
use products, or both. The test substance column specifies which 
substance is to be subjected to testing. Thus, the data from a certain 
kind of study may be required to support the registration of each end-
use product, but the test substance column may state that the particular 
test shall be performed using, for example, the technical grade of the 
active ingredient(s) in the end-use product.
    (b) Manufacturing-use products (MP) and end-use products (EP) 
containing a single active ingredient and no inert ingredients are 
identical in composition to each other and to the technical grade of the 
active ingredient (TGAI) from which they were derived, and therefore, 
the data from a test conducted using any one of these as the test 
substance (e.g., TGAI) is also suitable to meet the requirement (if any) 
for the same test to be conducted using either of the other substances 
(i.e., MP or EP).

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



Sec. 158.108  Relationship of Pesticide Assessment Guidelines to data requirements.

    The Pesticide Assessment Guidelines contain the standards for 
conducting acceptable tests, guidance on evaluation and reporting of 
data, definition of terms, further guidance on when data are required, 
and examples of acceptable protocols. They are available through the 
National Technical Information Service, 5285 Port Royal Road, 
Springfield, VA 22161 (703-487-4650). The following Subdivisions of the 
Pesticide Assessment Guidelines, referenced to the appropriate sections 
of this part, are currently available:

[[Page 86]]



----------------------------------------------------------------------------------------------------------------
                                                                                                Corresponding
       Subdivision                      Title                        NTIS order no.          section(s) in this
                                                                                                    part
----------------------------------------------------------------------------------------------------------------
            D             Product Chemistry................  PB83-153890                    Secs.  158.150-158.1
                                                                                                     90
            E             Hazard Evaluation: Wildlife and    PB83-153908                    Sec.  158.490
                           Aquatic Organisms.
            F             Hazard Evaluation: Humans and      PB83-153916                    Sec.  158.340
                           Domestic Animals.
            G             Product Performance..............  PB83-153924                    Sec.  158.640
            I             Experimental Use Permits.........  PB83-153932                    Secs.  158.20-158.74
                                                                                                      0
            J             Hazard Evaluation: Nontarget       PB83-153940                    Sec.  158.540
                           Plants.
            K             Reentry Protection...............  PB85-120962                    Sec.  158.390
            L             Hazard Evaluation: Nontarget       PB83-153957                    Sec.  158.590
                           Insect.
            M             Biorational Pesticides...........  PB83-153965                    Secs.  158.690-158.7
                                                                                                     40
            N             Environmental Fate...............  PB83-153973                    Sec.  158.290
            O             Residue Chemistry................  PB83-153961                    Sec.  158.240
            R             Spray Drift Evaluation...........  PB84-189216                    Sec.  158.440
----------------------------------------------------------------------------------------------------------------

[53 FR 15993, May 4, 1988]



             Subpart C--Product Chemistry Data Requirements

    Source: 53 FR 15993, May 4, 1988, unless otherwise noted.



Sec. 158.150  General.

    (a) Applicability. This subpart describes the product chemistry data 
that are required to support the registration of each pesticide product. 
The information specified in this subpart must be submitted with each 
application for new or amended registration or for reregistration, if it 
has not been submitted previously or if the previously submitted 
information is not complete and accurate. References in this subpart to 
the ``applicant'' include the registrant if the information is required 
for a registered product.
    (b) Purpose--(1) Product composition. (i) Data on product 
composition are needed to support the conclusions expressed in the 
statement of formula. These data include information on the starting 
materials, production or formulating process, possible formation of 
impurities, results of preliminary analysis of product samples, a 
description of analytical methods to identify and quantify ingredients 
and validation data for such methods. In addition, an applicant is 
required to certify the limits for ingredients of his product.
    (ii) Product composition data are compared to the composition of 
materials used in required testing under subpart D of this part. This 
comparison indicates which components of a pesticide product have been 
evaluated by a particular study, and might lead to a conclusion that 
another study is needed. Based on conclusions concerning the product's 
composition and its toxic properties, appropriate use restrictions, 
labeling requirements, or special packaging requirements may be imposed.
    (iii) Product composition data, including certified limits of 
components, are used to determine whether a product is ``identical or 
substantially similar'' to another product or ``differs only in ways 
that do not significantly increase the risk of unreasonable adverse 
effects on the environment'' (FIFRA sec. 3(c)(7)(A)). In nearly every 
case, this determination involves a comparison of the composition of an 
applicant's product with that of currently registered products.
    (2) Certified limits. Certified limits required by Sec. 158.175 are 
used in two ways. First, the Agency considers the certified limits in 
making the registration determination required by sections 3(c)(5), 
3(c)(7) and 3(d) of the Act and making other regulatory decisions 
required by the Act. Second, the Agency may collect commercial samples 
of the registered products and analyze them for the active 
ingredient(s), inert ingredients, or impurities determined by the Agency 
to be toxicologically significant. If, upon analysis the composition of 
such a sample is found to differ from that certified, the results may be 
used by the Agency in regulatory actions under FIFRA sec. 12(a)(1)(C) 
and other pertinent sections.
    (3) Nominal concentration. The nominal concentration required by 
Sec. 158.155 is the amount of active ingredient that is most likely to 
be present in the product when produced. Unlike the certified limits, 
which are the outer limits

[[Page 87]]

of the range of the product's ingredients and thus are present only in a 
small proportion of the products, the nominal concentration is the 
amount that typically is expected to result from the applicant's 
production or formulating process. The nominal concentration together 
with production process information is used to gauge the acceptability 
of the certified limits presented by the applicant. The nominal 
concentration is used by the Agency as the basis for enforceable 
certified limits if the applicant has chosen not to specify certified 
limits of his own (thereby agreeing to abide by the standard limits in 
Sec. 158.175).
    (4) Physical and chemical characteristics. (i) Data on the physical 
and chemical characteristics of pesticide active ingredients and 
products are used to confirm or provide supportive information on their 
identity. Such data are also used in reviewing the production or 
formulating process used to produce the pesticide or product. For 
example, data that indicate significant changes in production or 
formulation might indicate the need for additional information on 
product composition.
    (ii) Certain information (e.g., color, odor, physical state) is 
needed for the Agency to respond to emergency requests for 
identification of unlabeled pesticides involved in accidents or spills. 
Physicians, hospitals, and poison control centers also request this 
information to aid in their identification of materials implicated in 
poisoning episodes.
    (iii) Certain physical and chemical data are used directly in the 
hazard assessment. These include stability, oxidizing and reducing 
action, flammability, explodability, storage stability, corrosion, and 
dielectric breakdown voltage. For example, a study of the corrosion 
characteristics of a pesticide is needed to evaluate effects of the 
product formulation on its container. If the pesticide is highly 
corrosive, measures can be taken to ensure that lids, liners, seams or 
container sides will not be damaged and cause the contents to leak 
during storage, transport, handling, or use. The storage stability study 
provides data on change (or lack of change) in product composition over 
time. If certain ingredients decompose, other new chemicals are formed 
whose toxicity and other characteristics must be considered.
    (iv) Certain data are needed as basic or supportive evidence in 
initiating or evaluating other studies. For example, the octanol/water 
partition coefficient is used as one of the criteria to determine 
whether certain fish and wildlife toxicity or accumulation studies must 
be conducted. Vapor pressure data are needed, among other things, to 
determine suitable reentry intervals and other label cautions pertaining 
to worker protection. Data on viscosity and miscibility provide 
necessary information to support acceptable labeling for tank mix and 
spray applications.



Sec. 158.153  Definitions.

    The following terms are defined for the purposes of this subpart:
    (a) Active ingredient means any substance (or group of structurally 
similar substances, if specified by the Agency) that will prevent, 
destroy, repel or mitigate any pest, or that functions as a plant 
regulator, desiccant, or defoliant within the meaning of FIFRA sec. 
2(a).
    (b) End use product means a pesticide product whose labeling
    (1) Includes directions for use of the product (as distributed or 
sold, or after combination by the user with other substances) for 
controlling pests or defoliating, desiccating or regulating growth of 
plants, and
    (2) Does not state that the product may be used to manufacture or 
formulate other pesticide products.
    (c) Formulation means
    (1) The process of mixing, blending, or dilution of one or more 
active ingredients with one or more other active or inert ingredients, 
without an intended chemical reaction, to obtain a manufacturing use 
product or an end use product, or
    (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,

[[Page 88]]

side reaction products, contaminants, and degradation products.
    (e) Impurity associated with an active ingredient means:
    (1) Any impurity present in the technical grade of active 
ingredient; and
    (2) Any impurity which forms in the pesticide product through 
reactions between the active ingredient and any other component of the 
product or packaging of the product.
    (f) Inert ingredient means any substance (or group of structurally 
similar substances if designated by the Agency), other than an active 
ingredient, which is intentionally included in a pesticide product.
    (g) Integrated system means a process for producing a pesticide 
product that:
    (1) Contains any active ingredient derived from a source that is not 
an EPA-registered product; or
    (2) Contains any active ingredient that was produced or acquired in 
a manner that does not permit its inspection by the Agency under FIFRA 
sec. 9(a) prior to its use in the process.
    (h) Manufacturing use product means any pesticide product other than 
an end use product. A product may consist of the technical grade of 
active ingredient only, or may contain inert ingredients, such as 
stabilizers or solvents.
    (i) Nominal concentration means the amount of an ingredient which is 
expected to be present in a typical sample of a pesticide product at the 
time the product is produced, expressed as a percentage by weight.
    (j) Starting material means a substance used to synthesize or purify 
a technical grade of active ingredient (or the practical equivalent of 
the technical grade ingredient if the technical grade cannot be 
isolated) by chemical reaction.
    (k) Technical grade of active ingredient means a material containing 
an active ingredient:
    (1) Which contains no inert ingredient, other than one used for 
purification of the active ingredient; and
    (2) Which is produced on a commercial or pilot-plant production 
scale (whether or not it is ever held for sale).



Sec. 158.155  Product composition.

    Information on the composition of the pesticide product must be 
furnished. The information required by paragraphs (a), (b) and (f) of 
this section must be provided for each product. In addition, if the 
product is produced by an integrated system, the information on 
impurities required by paragraphs (c) and (d) must be provided.
    (a) Active ingredient. The following information is required for 
each active ingredient in the product:
    (1) If the source of any active ingredient in the product is an EPA-
registered product:
    (i) The chemical and common name (if any) of the active ingredient, 
as listed on the source product.
    (ii) The nominal concentration of the active ingredient in the 
product, based upon the nominal concentration of active ingredient in 
the source product.
    (iii) Upper and lower certified limits of the active ingredient in 
the product, in accordance with Sec. 158.175.
    (2) If the source of any active ingredient in the product is not an 
EPA-registered product:
    (i) The chemical name according to Chemical Abstracts Society 
nomenclature, the CAS Registry Number, and any common names.
    (ii) The molecular, structural, and empirical formulae, and the 
molecular weight or weight range.
    (iii) The nominal concentration.
    (iv) Upper and lower certified limits in accordance with 
Sec. 158.175.
    (v) The purpose of the ingredient in the formulation.
    (b) Inert ingredients. The following information is required for 
each inert ingredient (if any) in the product:
    (1) The chemical name of the ingredient according to Chemical 
Abstracts Society nomenclature, the CAS Registry Number, and any common 
names (if known). If the chemical identity or chemical composition of an 
ingredient is not known to the applicant because 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

[[Page 89]]

Agency may require that the applicant know the identity of a specific 
ingredient in such a mixture. If the Agency requires specific knowledge 
of an ingredient, it will notify the applicant in writing.
    (2) The nominal concentration in the product.
    (3) Upper and lower certified limits in accordance with 
Sec. 158.175.
    (4) The purpose of the ingredient in the formulation.
    (c) Impurities of toxicological significance associated with the 
active ingredient. For each impurity associated with the active 
ingredient that is determined to be toxicologically significant, the 
following information is required:
    (1) Identification of the ingredient as an impurity.
    (2) The chemical name of the impurity.
    (3) The nominal concentration of the impurity in the product.
    (4) A certified upper limit, in accordance with Sec. 158.175.
    (d) Other impurities associated with the active ingredient. For each 
other impurity associated with an active ingredient that was found to be 
present in any sample at a level equal to or greater than 0.1 percent by 
weight of the technical grade active ingredient, the following 
information is required:
    (1) Identification of the ingredient as an impurity.
    (2) Chemical name of the impurity.
    (3) The nominal concentration of the impurity in the final product.
    (e) Impurities associated with an inert ingredient. [Reserved]
    (f) Ingredients that cannot be characterized. If the identity of any 
ingredient or impurity cannot be specified as a discrete chemical 
substance (such as mixtures that cannot be characterized or isomer 
mixtures), the applicant must provide sufficient information to enable 
EPA to identify its source and qualitative composition.



Sec. 158.160  Description of materials used to produce the product.

    The following information must be submitted on the materials used to 
produce the product:
    (a) Products not produced by an integrated system.
    (1) For each active ingredient that is derived from an EPA-
registered product:
    (i) The name of the EPA-registered product.
    (ii) The EPA registration number of that product.
    (2) For each inert ingredient:
    (i) Each brand name, trade name, or other commercial designation of 
the ingredient.
    (ii) All information that the applicant knows (or that is reasonably 
available to him) concerning the composition (and, if requested by the 
Agency, chemical and physical properties) of the ingredient, including a 
copy of technical specifications, data sheets, or other documents 
describing the ingredient.
    (iii) If requested by the Agency, the name and address of the 
producer of the ingredient or, if that information is not known to the 
applicant, the name and address of the supplier of the ingredient.
    (b) Products produced by an integrated system. (1) The information 
required by paragraph (a)(1) of this section concerning each active 
ingredient that is derived from an EPA-registered product (if any).
    (2) The following information concerning each active ingredient that 
is not derived from an EPA-registered product:
    (i) The name and address of the producer of the ingredient (if 
different from the applicant).
    (ii) Information on each starting material used to produce the 
active ingredient, as follows:
    (A) Each brand name, trade name, or other commercial designation of 
the starting material.
    (B) The name and address of the person who produces the starting 
material or, if that information is not known to 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

[[Page 90]]

sheets, or other documents describing it.
    (3) The information required by paragraph (a)(2) of this section 
concerning each inert ingredient.
    (c) Additional information. On a case-by-case basis, the Agency may 
require additional information on substances used in the production of 
the product.



Sec. 158.162  Description of production process.

    If the product is produced by an integrated system, the applicant 
must submit information on the production (reaction) processes used to 
produce the active ingredients in the product. The applicant must also 
submit information on the formulation process, in accordance with 
Sec. 158.165.
    (a) Information must be submitted for the current production process 
for each active ingredient that is not derived from an EPA-registered 
product. If the production process is not continuous (a single reaction 
process from starting materials to active ingredient), but is 
accomplished in stages or by different producers, the information must 
be provided for each such production process.
    (b) The following information must be provided for each process 
resulting in a separately isolated substance:
    (1) the name and address of the producer who uses the process, if 
not the same as the applicant.
    (2) A general characterization of the process (e.g., whether it is a 
batch or continuous process).
    (3) A flow chart of the chemical equations of each intended reaction 
occurring at each step of the process, the necessary reaction 
conditions, and the duration of each step and of the entire process.
    (4) The identity of the materials used to produce the product, their 
relative amounts, and the order in which they are added.
    (5) A description of the equipment used that may influence the 
composition of the substance produced.
    (6) A description of the conditions (e.g., temperature, pressure, 
pH, humidity) that are controlled during each step of the process to 
affect the composition of the substance produced, and the limits that 
are maintained.
    (7) A description of any purification procedures (including 
procedures to recover or recycle starting materials, intermediates or 
the substance produced).
    (8) A description of the procedures used to assure consistent 
composition of the substance produced, e.g., calibration of equipment, 
sampling regimens, analytical methods, and other quality control 
methods.



Sec. 158.165  Description of formulation process.

    The applicant must provide information on the formulation process of 
the product (unless the product consists solely of a technical grade of 
active ingredient), as required by the following sections:
    (a) Section 158.162(b)(2), pertaining to characterization of the 
process.
    (b) Section 158.162(b)(4), pertaining to ingredients used in the 
process.
    (c) Section 158.162(b)(5), pertaining to process equipment.
    (d) Section 158.162(b)(6), pertaining to the conditions of the 
process.
    (e) Section 158.162(b)(8), pertaining to quality control measures.



Sec. 158.167  Discussion of formation of impurities.

    The applicant must provide a discussion of the impurities that may 
be present in the product, and why they may be present. The discussion 
should be based on established chemical theory and on what the applicant 
knows about the starting materials, technical grade of active 
ingredient, inert ingredients, and production or formulation process. If 
the applicant has reason to believe that an impurity that EPA would 
consider toxicologically significant may be present, the discussion must 
include an expanded discussion of the possible formation of the impurity 
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.

[[Page 91]]

    (2) Each other impurity which the applicant has reason to believe 
may be present in his product at any time before use at a level equal to 
or greater than 0.1 percent (1000 ppm) by weight of the technical grade 
of the active ingredient, based on what he knows about the following:
    (i) The composition (or composition range) of each starting material 
used to produce his product.
    (ii) The impurities which he knows are present (or believes are 
likely to be present) in the starting materials, and the known or 
presumed level (or range of levels) of those impurities.
    (iii) The intended reactions and side reactions which may occur in 
the production of the product, and the relative amounts of byproduct 
impurities produced by such reactions.
    (iv) The possible degradation of the ingredients in the product 
after its production but prior to its use.
    (v) Post-production reactions between the ingredients in the 
product.
    (vi) The possible migration of components of packaging materials 
into the pesticide.
    (vii) The possible carryover of contaminants from use of production 
equipment previously used to produce other products or substances.
    (viii) The process control, purification and quality control 
measures used to produce the product.
    (b) Products not produced by an integrated system. Each impurity 
associated with the active ingredient which the applicant has reason to 
believe may be present in the product at any time before use at a level 
equal to or greater than 0.1 percent (1000 ppm) by weight of the product 
based on what he knows about the following:
    (1) The possible carryover of impurities present in any registered 
product which serves as the source of any of the product's active 
ingredients. The identity and level of impurities in the registered 
source need not be discussed or quantified unless known to the 
formulator.
    (2) The possible carryover of impurities present in the inert 
ingredients in the product.
    (3) Possible reactions occurring during the formulation of the 
product between any of its active ingredients, between the active 
ingredients and inert ingredients, or between the active ingredients and 
the production equipment.
    (4) Post-production reactions between any of the product's active 
ingredients and any other component of the product or its packaging.
    (5) Possible migration of packaging materials into the product.
    (6) Possible contaminants resulting from earlier use of equipment to 
produce other products.
    (c) Expanded discussion. On a case-by-case basis, the Agency may 
require an expanded discussion of information of impurities:
    (1) From other possible chemical reactions;
    (2) Involving other ingredients; or
    (3) At additional points in the production or formulation process.



Sec. 158.170  Preliminary analysis.

    (a) If the product is produced by an integrated system, the 
applicant must provide a preliminary analysis of each technical grade of 
active ingredient contained in the product to identify all impurities 
present at 0.1 percent or greater of the TGAI. The preliminary analysis 
should be conducted at the point in the production process after which 
no further chemical reactions designed to produce or purify the 
substance are intended.
    (b) Based on the preliminary analysis, a statement of the 
composition of the technical grade of active ingredient must be 
provided. If the technical grade of active ingredient cannot be 
isolated, a statement of the composition of the practical equivalent of 
the technical grade of active ingredient must be submitted.



Sec. 158.175  Certified limits.

    The applicant must propose certified limits for the ingredients in 
the product. Certified limits become legally binding limits upon 
approval of the application. Certified limits will apply to the product 
from the date of production to date of use, unless the product label 
bears a statement prohibiting use after a certain date, in which case 
the certified limits will apply only until that date.

[[Page 92]]

    (a) Ingredients for which certified limits are required. Certified 
limits are required on the following ingredients of a pesticide product:
    (1) An upper and lower limit for each active ingredient.
    (2) An upper and lower limit for each inert ingredient.
    (3) If the product is a technical grade of active ingredient or is 
produced by an integrated system, an upper limit for each impurity of 
toxicological significance associated with the active ingredient and 
found to be present in any sample of the product.
    (4) On a case-by-case basis, certified limits for other ingredients 
or impurities as specified by EPA.
    (b) EPA determination of certified limits for active and inert 
ingredients. (1) Unless the applicant proposes different limits as 
provided in paragraph (c) of this section, the upper and lower certified 
limits for active and inert ingredients will be determined by EPA. EPA 
will calculate the certified limits on the basis of the nominal 
concentration of the ingredient in the product, according to the table 
in paragraph (b)(2) of this section.
    (2) Table of standard certified limits.

------------------------------------------------------------------------
                                      The certified limits for that
  If the nominal concentration        ingredient will be as follows:
   (N) for the ingredient is:   ----------------------------------------
                                     Upper limit          Lower limit
------------------------------------------------------------------------
N  1.0%.............  N + 10%N             N - 10%N
1.0%  N  20.0%......  N + 5%N              N - 5%N
20.0%  N  100.0%....  N + 3%N              N - 3%N
------------------------------------------------------------------------

    (c) Applicant proposed limits. (1) The applicant may propose a 
certified limit for an active or inert ingredient that differs from the 
standard certified limit calculated according to paragraph (b)(2) of 
this section.
    (2) If certified limits are required for impurities, the applicant 
must propose a certified limit. The standard certified limits may not be 
used for such substances.
    (3) Certified limits should:
    (i) Be based on a consideration of the variability of the 
concentration of the ingredient in the product when good manufacturing 
practices and normal quality control procedures are used.
    (ii) Allow for all sources of variability likely to be encountered 
in the production process.
    (iii) Take into account the stability of the ingredient in the 
product and the possible formation of impurities between production and 
sale of distribution.
    (4) The applicant may include an explanation of the basis of his 
proposed certified limits, including how the certified limits were 
arrived at (e.g., sample analysis, quantitative estimate based on 
production process), and its accuracy and precision. This will be 
particularly useful if the range of the certified limit for an active or 
inert ingredient is greater than the standard certified limits.
    (d) Special cases. If the Agency finds unacceptable any certified 
limit (either standard or applicant-proposed), the Agency will inform 
the applicant of its determination and will provide supporting reasons. 
EPA may also recommend alternative limits to the applicant. The Agency 
may require, on a case-by-case basis, any or all of the following:
    (1) More precise limits.
    (2) More thorough explanation of how the certified limits were 
determined.
    (3) A narrower range between the upper and lower certified limits 
than that proposed.
    (e) Certification statement. The applicant must certify the accuracy 
of the information presented, and that the certified limits of the 
ingredients will be maintained. The following statement, signed by the 
authorized representative of the company, is acceptable:

    I hereby certify that, for purposes of FIFRA sec. 12(a)(1)(C), the 
description of the composition of [product name], EPA Reg. No. [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.

[[Page 93]]



Sec. 158.180  Enforcement analytical method.

    An analytical method suitable for enforcement purposes must be 
provided for each active ingredient in the product and for each other 
ingredient or impurity that is determined to be toxicologically 
significant.



Sec. 158.190  Physical and chemical characteristics.

    (a) Table. Sections 158.50 and 158.100 through 158.102 describe how 
to use this table to determine the physical and chemical characteristics 
data requirements and the substance to be tested.

----------------------------------------------------------------------------------------------------------------
                                            All general use               Test substance
                                               patterns      ---------------------------------------- Guidelines
     Kind of data required         (b)     (requirements are                                           reference
                                  Notes   the same for every  Data to support MP  Data to support EP      No.
                                             use pattern)
----------------------------------------------------------------------------------------------------------------
Color..........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-2
Physical state.................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-3
Odor...........................  .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-4
Melting point..................  (\1\)    [R]...............  TGAI..............  TGAI..............     63-5
Boiling point..................  (\2\)    [R]...............  TGAI..............  TGAI..............     63-6
Density, bulk density, or        .......  [R]...............  MP and TGAI.......  EP* and TGAI......     63-7
 specific gravity.
Solubility.....................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-8
Vapor pressure.................  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......     63-9
Dissociation constant..........  .......  [R]...............  TGAI or PAI.......  TGAI or PAI.......    63-10
Octanol/water partition          (\3\)    [CR]..............  PAI...............  PAI...............    63-11
 coefficient.
pH.............................  (\4\)    [CR]..............  MP and TGAI.......  EP* and TGAI......    63-12
Stability......................  .......  [R]...............  TGAI..............  TGAI..............    63-13
Oxidizing or reducing action...  (\5\)    [CR]..............  ..................  ..................  ..........
Flammability...................  (\6\)    [CR]..............  MP................  EP*...............    63-15
Explodability..................  (\7\)    [R]...............  MP................  EP*...............    63-16
Storage stability..............  .......  [R]...............  MP................  EP*...............    63-17
Viscosity......................  (\8\)    [CR]..............  MP................  EP*...............    63-18
Miscibility....................  (\9\)    [CR]..............  MP................  EP*...............    63-19
Corrosion characteristics......  .......  [R]...............  MP................  EP*...............    63-20
Dielectric breakdown voltage...  (\10\)   [CR]..............  ..................  EP*...............    63-21
Other requirements: Submittal    (\11\)   [CR]..............  MP, TGAI, PAI.....  EP*, TGAI, PAI....     64-1
 of samples.
----------------------------------------------------------------------------------------------------------------
Key: R = Required; CR = Conditionally Required; [  ] = Brackets (i.e. [R],[CR]) indicate data requirements that
  apply when an experimental use permit is being sought; MP = Manufacturing Use Product, EP* = End Use Product;
  asterisk indicates those registrants that end-use applicants (i.e. formulators) need not satisfy, if their
  active ingredient(s) is (are) purchased from a registered source; TGAI = Technical Grade of the Active
  Ingredient; PAI = Pure Active Ingredient.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this
  section.
(\1\) Required if technical chemical is a solid at room temperature.
(\2\) Required if technical chemical is a liquid at room temparature.
(\3\) Required if technical chemical is organic and non-polar.
(\4\) Required if test substance is dispersible with water.
(\5\) Required if product contains an oxidizing or reducing agent.
(\6\) Required if product contains combustible liquids.
(\7\) Required if product is potentially explosive.
(\8\) Required if product is a liquid.
(\9\) Required if product is a emulsifiable liquid and is to be diluted with petroleum solvents.
(\10\) Required if end-use product is a liquid and is to be used around electrical equipment.
(\11\) Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a
  product produced by an integrated system when the new TGAI is first used as a formulating ingredient in
  products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical
  standard is also required at this time. Samples of end use products produced by an integrated system must be
  submitted on a case-by-case basis.


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



                   Subpart D--Data Requirement Tables



Sec. 158.202  Purposes of the registration data requirements.

    (a) General. The data requirements for registration are intended to 
generate data and information necessary to address concerns pertaining 
to the identity, composition, potential adverse effects and 
environmental fate of each pesticide.
    (b) [Reserved]
    (c) Residue chemistry. (1) Residue Chemistry Data are used by the 
Agency to estimate the exposure of the general population to pesticide 
residues in food and for setting and enforcing tolerances for pesticide 
residues in food or feed.

[[Page 94]]

    (2) Information on the chemical identity and composition of the 
pesticide product, the amounts, frequency and time of pesticide 
application, and results of test on the amount of residues remaining on 
or in the treated food or feed, are needed to support a finding as to 
the magnitude and identity of residues which result in food or animal 
feed as a consequence of a proposed pesticide usage.
    (3) Residue chemistry data are also needed to support the adequacy 
of one or more methods for the enforcement of the tolerance, and to 
support practicable methods for removing residues that exceed any 
proposed tolerance.
    (d) Environmental fate--(1) General. The data generated by 
environmental fate studies are used to: assess the toxicity to man 
through exposure of humans to pesticide residues remaining after 
application, either upon reentering treated areas or from consuming 
inadvertently-contaminated food; assess the presence of widely 
distributed and persistent pesticides in the environment which may 
result in loss of usable land, surface water, ground water, and wildlife 
resources; and, assess the potential environmental exposure of other 
nontarget organisms, such as fish and wildlife, to pesticides. Another 
specific purpose of the environmental fate data requirements is to help 
applicants and the Agency estimate expected environmental concentrations 
of pesticides in specific habitats where threatened or endangered 
species or other wildlife populations at risk are found.
    (2) Degradation studies. The data from hydrolysis and photolysis 
studies are used to determine the rate of pesticide degradation and to 
identify pesticides that may adversely affect nontarget organisms.
    (3) Metabolism studies. Data generated from aerobic and anaerobic 
metabolism studies are used to determine the nature and availability of 
pesticides to rotational crops and to aid in the evaluation of the 
persistence of a pesticide.
    (4) Mobility studies. These data requirements pertain to leaching, 
adsorption/desorption, and volatility of pesticides. They provide 
information on the mode of transport and eventual destination of the 
pesticide in the environment. This information is used to assess 
potential environmental hazards related to: contamination of human and 
animal food; loss of usable land and water resources to man through 
contamination of water (including ground water); and habitat loss of 
wildlife resulting from pesticide residue movement or transport in the 
environment.
    (5) Dissipation studies. The data generated from dissipation studies 
are used to assess potential environmental hazards (under actual field 
use conditions) related to: reentry into treated areas; hazards from 
residues in rotational crop and other food sources; and the loss of land 
as well as surface and ground water resources.
    (6) Accumulation studies. Accumulation studies indicate pesticide 
residue levels in food supplies that originate from wild sources or from 
rotational crops. Rotational crop studies are necessary to establish 
realistic crop rotation restrictions and to determine if tolerances may 
be needed for residues on rotational crops. Data from irrigated crop 
studies are used to determine the amount of pesticide residues that 
could be taken up by representative crops irrigated with water 
containing pesticide residues. These studies allow the Agency to 
establish label restrictions regarding application of pesticides on 
sites where the residues can be taken up by irrigated crops. These data 
also provide information that aids the Agency in establishing 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.

[[Page 95]]

    (1) Acute studies. Determination of acute oral, dermal and 
inhalation toxicity is usually the initial step in the assessment and 
evaluation of the toxic characteristics of a pesticide. These data 
provide information on health hazards likely to arise soon after, and as 
a result of, short-term exposure. Data from acute studies serve as a 
basis for classification and precautionary labeling. For example, acute 
toxicity data are used to calculate farmworker reentry intervals and to 
develop precautionary label statements pertaining to protective clothing 
requirements for applicators. They also: provide information used in 
establishing the appropriate dose levels in subchronic and other 
studies; provide initial information on the mode of toxic action(s) of a 
substance; and determine the need for child resistant packaging. 
Information derived from primary eye and primary dermal irritation 
studies serves to identify possible hazards from exposure of the eyes, 
associated mucous membranes and skin.
    (2) Subchronic studies. Subchronic tests provide information on 
health hazards that may arise from repeated exposures over a limited 
period of time. They provide information on target organs and 
accumulation potential. The resulting data are also useful in selecting 
dose levels for chronic studies and for establishing safety criteria for 
human exposure. These tests are not capable of detecting those effects 
that have a long latency period for expression (e.g., carcinogenicity).
    (3) Chronic studies. Chronic toxicity (usually conducted by feeding 
the test substance to the test species) studies are intended to 
determine the effects of a substance in a mammalian species following 
prolonged and repeated exposure. Under the conditions of this test, 
effects which have a long latency period or are cumulative should be 
detected. The purpose of long-term oncogenicity studies is to observe 
test animals over most of their life span for the development of 
neoplastic lesions during or after exposure to various doses of a test 
substance by an appropriate route of administration.
    (4) Teratogenicity and reproduction studies. The teratogenicity 
study is designed to determine the potential of the test substance to 
induce structural and/or other abnormalities to the fetus as the result 
of exposure of the mother during pregnancy. Two-generation reproduction 
testing is designed to provide information concerning the general 
effects of a test substance on gonadal function, estrus cycles, mating 
behavior, conception, parturition, lactation, weaning, and the growth 
and development of the offspring. The study may also provide information 
about the effects of the test substance on neonatal morbidity, 
mortality, and preliminary data on teratogenesis and serve as a guide 
for subsequent tests.
    (5) Mutagenicity studies. For each test substance a battery of tests 
are required to assess potential to affect the mammalian cell's genetic 
components. The objectives underlying the selection of a battery of 
tests for mutagenicity assessment are:
    (i) To detect, with sensitive assay methods, the capacity of a 
chemical to alter genetic material in cells.
    (ii) To determine the relevance of these mutagenic changes to 
mammals.
    (iii) When mutagenic potential is demonstrated, to incorporate these 
findings in the assessment of heritable effects, oncogenicity, and 
possibly, other health effects.
    (6) Metabolism studies. Data from studies on the absorption, 
distribution, excretion, and metabolism of a pesticide aid in the 
valuation of test results from other toxicity studies and in the 
extrapolation of data from animals 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

[[Page 96]]

spray drift are derived from studies of droplet size spectrum and spray 
drift field evaluations. These data contribute to development of the 
overall exposure estimate and along with data on toxicity for humans, 
fish and wildlife, or plants are used to assess the potential hazard of 
pesticides to these organisms. A purpose common to all these tests is to 
provide data which will be used to determine the need for (and 
appropriate wording for) precautionary labeling to minimize the 
potential adverse effect to nontarget organisms.
    (h) Hazard to nontarget organisms--(1) General. The information 
required to assess hazards to nontarget organisms are derived from tests 
to determine pesticidal effects on birds, mammals, fish, terrestrial and 
aquatic invertebrates, and plants. These tests include short-term acute, 
subacute, reproduction, simulated field, and full field studies arranged 
in a hierarchial or tier system which progresses from the basic 
laboratory tests to the applied field tests. The results of each tier of 
tests must be evaluated to determine the potential of the pesticide to 
cause adverse effects, and to determine whether further testing is 
required. A purpose common to all data requirements is to provide data 
which determines the need for (and appropriate wording for) 
precautionary label statements to minimize the potential adverse effects 
to nontarget organisms.
    (2) Short term studies. The short-term acute and subchronic 
laboratory studies provide basic toxicity information which serves as a 
starting point for the hazard assessment. These data are used: to 
establish acute toxicity levels of the active ingredient to the test 
organisms; to compare toxicity information with measured or estimated 
pesticide residues in the environment in order to assess potential 
impacts on fish, wildlife and other nontarget organisms; and to indicate 
whether further laboratory and/or field studies are needed.
    (3) Long term and field studies. Additional studies (i.e., avian, 
fish, and invertebrate reproduction, lifecycle studies and plant field 
studies) may be required when basic data and environmental conditions 
suggest possible problems. Data from these studies are used to: estimate 
the potential for chronic effects, taking into account the measured or 
estimated residues in the environment; and to determine if additional 
field or laboratory data are necessary to further evaluate hazards. 
Simulated field and/or field data are used to examine acute and chronic 
adverse effects on captive or monitored fish and wildlife populations 
under natural or near-natural environments. Such studies are required 
only when predictions as to possible adverse effects in less extensive 
studies cannot be made, or when the potential for adverse effects is 
high.
    (i) Product performance. Requirements to develop data on product 
performance provide a mechanism to ensure that pesticide products will 
control the pests listed on the label and that unnecessary pesticide 
exposure to the environment will not occur as a result of the use of 
ineffective products. Specific performance standards are used to 
validate the efficacy data in the public health areas, including 
disinfectants used to control microorganisms infectious to man in any 
area of the inanimate environment and those pesticides used to control 
vertebrates (such as rodents, birds, bats and skunks) that may directly 
or indirectly transmit diseases to humans.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
May 4, 1988]


[[Page 97]]


Sec. 158.240

Sec.  158.240  Residue chemistry data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
residue chemistry data requirements and the substances to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food corp    Nonfood   Food corp   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity.............        (1)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............       171-2
Directions for use............        (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        ................  ................       171-3
Nature of the residue:
    Plants....................      (13),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       PAIRA...........  PAIRA...........       171-4
                                     (14)
    Livestock.................       (3),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       [CR]       PAIRA and plant   PAIRA and plant        171-4
                                    (13),                                                                                                          metabloites.      metabolites.
                                     (14)
Residue analytical method.....       (4),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       TGAI and          TGAI and               171-4
                                    (13),                                                                                                          metabolites.      metabolites.
                                    (14),
                                     (15)
Magnitude of the residue:
    Crop field trials.........      (13),  [R]         ..........  [R]         ..........  [R]        .........  .........  [CR]       [CR]       TEP.............  TEP.............       171-4
                                     (14)
    Processed food/feed.......  (5), (14)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       EP..............  EP..............       171-4
    Meat/milk/poultry/eggs....  (6), (14)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       TGAI or plant     TGAI or plant          171-4
                                                                                                                                                   metabolites.      metabolites.
    Potable water.............        (7)  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Fish......................        (8)  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Irrigated crops...........        (9)  ..........  ..........  [CR]        [CR]        .........  .........  .........  .........  .........  EP..............  EP..............       171-4
    Food handling.............      (10),  ..........  ..........  ..........  ..........  .........  .........  .........  .........  [CR]       EP..............  EP..............       171-4
                                     (14)
Reduction of residue..........      (11),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       Residue of        Residue of             171-5
                                     (14)                                                                                                          concern.          concern.
Proposed tolerance............      (12),  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       Residue of        Residue of             171-6
                                     (14)                                                                                                          concern.          concern.
Reasonable grounds in support        (14)  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       ................  ................       171-7
 of the petition.
Submittal of analytical              (14)  [R]         ..........  [R]         ..........  [R]        .........  .........  .........  [CR]       PAIRA...........  PAIRA...........      171-13
 reference standards.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required data; CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; EP=End-use product; TEP=Typical end-use
  product; MP=Manufacturing-use product; [  ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(b) Notes.-- The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The same chemical identity data as required under subpart C of this part are required, with emphasis on impurities that could constitute a residue problem.
(2) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(3) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(4) A residue method for enforcement of tolerances is needed whenever a numeric tolerance is proposed. Exemptions from the requirement of a tolerance will also usually require an analytical
  method. Analytical methods used to enforce residue limits for emergency exemptions, temporary tolerances and permanent tolerances must be available for use by enforcement agencies and thus
  may not be claimed as confidential business information.
(5) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
  tolerance.

[[Page 98]]

 
(6) Livestock feeding studies are required whenever a pesticide occurs as a residue in a livestock feed. Use involving direct application to livestock, including poultry, will require animal
  treatment residue studies.
(7) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
  for drinking purpose, by man or animals.
(8) Data on residue in fish are required whenever a pesticide is to be applied directly to water inhabited by fish.
(9) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
  ditches.
(10) Data on residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments. Disinfectants and sanitizers used in
  food or feed handling establishment are exempt from this requirement if their residues are regulated by the Food and Drug Administration at 21 CFR 178.1010.
(11) Reduction of residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level. Data on the level of residue in food as
  consumed will be used to obtain a more precise estimate of potential dietary exposure. The Agency recommends that such data be generated to support all pesticides requiring a tolerance in
  case new data are revealed which indicates the pesticide is more toxic than initially determined.
(12) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry eggs.
(13) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerance was
  established.
(14) Required to support registration of an indoor use pesticide if such a use could result in residues in food or feed.
(15) For all food uses, data on whether the FDA/USDA multiresidue methodology would detect and identify the pesticide are required.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
15999, May 4, 1988; 58 FR 34203, June 23, 1993]



Sec. 158.290

Sec.  158.290  Environmental fate data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
environmental fate data requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
    Degradation studies-lab
 
Hydrolysis....................  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        .........  TGAI or PAIRA...  TGAI or PAIRA...       161-1
Photodegradation:
    In water..................  .........  R           R           R           R           .........  .........  R          .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-2
    On soil...................        (1)  CR          ..........  ..........  ..........  .........  .........  CR         .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-3
    In air....................        (2)  CR          ..........  ..........  ..........  .........  .........  .........  .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       161-4
 
    Metabolism studies-lab
 
    Aerobic soil..............  .........  [R]         [R]         ..........  ..........  R          R          [R]        R          .........  TGAI or PAIRA...  TGAI or PAIRA...       162-1
    Anaerobic aquatic.........  .........  ..........  ..........  R           R           .........  .........  R          .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       162-3
    Aerobic aquatic...........  .........  ..........  ..........  [R]         [R]         .........  .........  .........  .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       162-4
 

[[Page 99]]

 
       Mobility studies
 
Leaching and adsorption/        .........  [R]         [R]         R           R           R          R          [R]        R          .........  TGAI or PAIRA...  TGAI or PAIRA...       163-1
 desorption.
Volatility:
    (Lab).....................        (2)  CR          ..........  ..........  ..........  CR         CR         .........  .........  .........  TEP.............  TEP.............       163-2
    (Field)...................        (2)  CR          ..........  ..........  ..........  CR         CR         .........  .........  .........  TEP.............  TEP.............       163-3
 
   Dissipation studies-field
 
Soil..........................  .........  R           R           ..........  ..........  .........  .........  .........  R          .........  TEP.............  TEP.............       164-1
Aquatic (sediment)............  .........  ..........  ..........  R           R           .........  .........  .........  .........  .........  TEP.............  TEP.............       164-2
Forestry......................  .........  ..........  ..........  ..........  ..........  .........  .........  R          .........  .........  TEP.............  TEP.............       164-3
Combination and tank mixes....        (2)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       164-4
Soil, long-term...............        (4)  CR          ..........  CR          ..........  .........  .........  .........  .........  .........  TEP.............  TEP.............       164-5
 
     Accumulation studies
 
Rotational crops:
    (Confined)................        (5)  [CR]        ..........  [CR]        ..........  .........  .........  .........  .........  .........  PAIRA...........  PAIRA...........       165-1
    (Field)...................        (6)  CR          ..........  CR          ..........  .........  .........  .........  .........  .........  TEP.............  TEP.............       165-2
Irrigated crops...............        (7)  ..........  ..........  [CR]        CR          .........  .........  .........  .........  .........  TEP.............  TEP.............       165-3
In fish.......................        (8)  [CR]        [CR]        [CR]        [CR]        .........  .........  [CR]       .........  .........  TGAI or PAIRA...  TGAI or PAIRA...       165-4
In aquatic non-target            (8), (9)  ..........  ..........  ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       165-5
 organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required: CR=Conditionally required; [  ]=Brackets (ie. [R], [CR], indicate data requirements that apply when an experimental use permit is being sought; TGAI=Technical grade of the
  active ingredient, PAIRA=``Pure'' active ingredient-radio labeled; TEP=typical end use product; EP =End use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if use involves application to soils solely by injection of the product into the soil or by incorporation of the product into the soil upon application.
 AAA(2) Required on case by case basis depending on product use pattern and other pertinent factors.
 AAA(3) Not required if anaerobic aquatic metabolism study has been conducted.
 AAA(4) Required if pesticide residues do not readily dissipate in soil.
 AAA(5) Confined accumulation study is required when it is reasonably foreseeable that any food or feed crop may be subsequently planted on the site of pesticide application.
 AAA(6) Field accumulation study is required if significant pesticide residue is likely to be present in soil at time of plant crop, as evidenced by residue data obtained from confined
  accumulation study.
 AAA(7) Required if it is reasonably foreseeable that water at treated site may be used for irrigation purposes.
 AAA(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
  organisms.
 AAA(9) Required unless tolerance or action level for fish has been granted.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988]


Sec. 158.340

Sec.  158.340  Toxicology data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
toxicology data requirements and the substance to be tested.
 


[[Page 100]]


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
         Acute testing
 
Acute oral toxicity--rat......        (1)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP               81-1
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
Acute dermal toxicity.........   (1), (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP               81-2
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
Acute inhalation toxicity--rat       (16)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....        81-3
Primary eye irritation--rabbit        (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-4
Primary dermal irritation.....   (1), (2)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-5
Dermal sensitization..........        (3)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............        81-6
Acute delayed neurotoxicity--         (4)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............        81-7
 hen.
 
      Subchronic testing
 
90-day feeding studies--rodent       (17)  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        82-1
 and nonrodent.
21-day dermal.................       (18)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI and EP*....        82-2
90-day dermal.................  (5), (19)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-3
90-day inhalation--rat                (6)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-4
90-day neurotoxicity:
  Hen.........................        (7)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-5
  Mammal......................        (8)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............        82-5
 
        Chronic testing
 
Chronic feeding--2 spp. rodent       (9),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-1
 and nonrodent.                     (13),
                                     (20)
Oncogenicity study--2 Spp. rat  (9), (21)  R           CR          R           CR          R          CR         CR         CR         CR         TGAI............  TGAI............        83-2
 and mouse preferred.
Teratogenicity--2 species.....      (10),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-3
                                     (15)
Reproduction, 2-generation....      (11),  [R]         CR          [R]         CR          [R]        CR         CR         CR         CR         TGAI............  TGAI............        83-4
                                     (14)
 
     Mutagenicity testing
 
Gene mutation.................       (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-2
Structural chromosomal               (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-2
 aberration.
Other genotoxic effects.......       (22)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............        84-4
 

[[Page 101]]

 
        Special testing
 
General metabolism............       (23)  R           CR          R           CR          R          CR         CR         CR         CR         PAI or PAIRA....  PAI or PAIRA....        85-1
Dermal penetration............       (24)  CR          CR          CR          CR          CR         CR         CR         CR         CR         Choice..........  Choice..........        85-2
Domestic animal safety........       (12)  CR          CR          CR          CR          .........  .........  CR         CR         .........  Choice..........  Choice..........        86-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 AAAKey:  R=Required data; CR=Conditionally required; [  ]=Brackets (ie [R], [CR] indicate data requirements that apply when an experimental use permit is being sought; MP=manufacturing-use
  product; EP*=End-Use Product; (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must satisfy, provided that their active ingredient(s) is (are)
  purchased from a registered source); TGAI=Technical grade of the active ingredient; PAI=``Pure'' active ingredient; PAIRA=``Pure'' active ingredient, radio-labeled; Choice=choice of several
  test substances, depending on studies required.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if test material is a gas or highly volatile.
(2) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as toxicity category I on the basis of potential eye and
  dermal irritation effects.
(3) Required unless repeated dermal exposure does not occur under conditions of use.
(4) Not required unless test material, is an organophosphate, or a metabolite or degradation product thereof which causes acetyl cholinesterase depression or is structurally related to a
  substance that causes delayed neurotoxicity.
(5) Required if use involves purposeful dermal application to, or prolonged exposure of, human skin.
(6) Required if use may result in repeated inhalation exposure at a concentration likely to be toxic. A test with duration of 21 days is required if pesticide is used on tobacco.
(7) Required if acute delayed neurotoxicity test showed neuropathy or neurotoxicity or if closely related structural to a compound which can induce these effects.
(8) Required if acute oral, dermal, or inhalation studies showed neuropathy or neurotoxicity.
(9)(i) Studies designed to simultaneously meet the requirements of both the chronic feeding and oncogenicity studies (i.e., a combined study) can be conducted.
(ii) Minimum acceptable test durations for chronic feeding and oncogenicity studies are as follows:
(A) Chronic rodent feeding study (food use pesticides)--24 months.
(B) Chronic rodent feeding study (non-food pesticides)--12 months is usually sufficient.
(C) Chronic nonrodent (i.e., dog) feeding study--12 months.
(D) Mouse oncogenicity study--18 months.
(E) Rat oncogenicity study--24 months.
(10) Required to support products intended for food uses and to supoort products intended for non-food uses if significant exposure of human females of child bearing age may reasonably be
  expected.
(11) Required to support products intended for food uses and to support products intended for non-food uses if use of the product is likely to result in human exposure over a portion of the
  human lifespan which is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for example; pesticides used in treated fabrics for wearing
  apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives; constant-release indoor pesticides which are used in aerosol form).
(12) Required on a case by case basis.
(13) In most cases, where theoretical maximum residue contribution (TMRC) exceeds 50 percent of the maximum permitted intake (MPI), a one year (or longer) interim report on a chronic feed
  study is required to support a temporary tolerance.
(14) In most cases, where theoretical maxium residue contribution (TMRC) exceeds 50 percent of the maxium permitted intake (MPI), a first generation (or longer) interim report on a
  multigeneration reproduction study is required to support a temporary tolerance.
(15) A teratology study in one species is required to support a temporary tolerance.
(16) Required if the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas volatile substances, or aerosol/particulate).
(17) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via the oral route.
(ii) Expected human exposure is over a limited portion of the human lifespan, yet is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for
  example, products requiring a temporary tolerance to support an experimental use permit or emergency exemption).
(18) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via skin contact.
(ii) Expected human skin contact is not purposeful, and such exposure is of limited frequence and duration (for example, such exposure could result from use of certain disinfectant, liquid
  fumigant or agricultural or home/garden pesticide products, and other circumstances where the Agency determines that more than acute dermal exposure is involved).
(iii) Data from a subchronic 90-day dermal toxicity study are not required.
(19) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable human exposure to the product, (e.g., swimming pool algaecides, pesticides
  for impregnating clothing), and if either of the following criteria are met:
(i) Data from a subchronic oral study are not required.
(ii) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient
  is the toxic moiety.
(20) Required if either of the following criteria are met:
(i) Use of the pesticide product is likely to result in repeated human exposure to the product, over a significant portion of the human life-span (for example, products intended for use in and
  around residences, swimming pools, and enclosed working spaces or their immediate vicinity).

[[Page 102]]

 
(ii) The use requires a tolerance for the pesticide or an exemption from the requirement to obtain a tolerance, or requires issuance of a food additive regulation.
(21) Required if any of the following criteria are met:
(i) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities:
(A) Is structually related to a recognized carcinogen.
(B) Is a substance that cause mutagenic effect as demonstrated by in vitro or in vivo testing.
(C) Produces in subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia) in any organ that may lead to neoplastic change.
(ii) The use requires a tolerance for the pesticide or exemption from the requirement to obtain a tolerance, or requires the issuance of a food additive regulation.
(iii) Use of the pesticide product is likely to result in human exposure over a portion of the human lifespan which is significant in terms of either the time the exposure occurs or the
  duration of exposure (for example; pesticides used in treated fabrics for wearing apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives;
  constant-release indoor pesticides which are used in aerosol form).
(22)(i) The required battery of mutagenicity tests must include tests appropriate to address the following three categories in accordance with the objectives set forth in Sec.  158.202:
(A) Gene mutations.
(B) Structural chromosomal aberrations.
(C) Other genotoxic effects as appropriate for the test substance, e.g., numerical chromosome abberations, direct DNA damage and repair, mammalian cells transformation, target organ/cell
  analysis.
(ii) Currently recognized tests for each of these categories are listed with the National Technical Information Service (NTIS). Applicants shall explain their reasons for selecting specific
  tests from the battery of currently recognized tests. Because of the rapid improvements in this field, applicants are encouraged to discuss with the Agency: test selection, protocol design
  and results of preliminary testing.
(iii) Not required if the pesticide use pattern precludes human exposure (e.g., nonvolatile pesticides packaged and used in enclosed bait boxes).
(23) Required if chronic feeding or oncogenicity studies are required.
(24) Dermal absorption studies required for compounds having a serious toxic effect as identified by oral or inhalation studies, for which a significant route of human exposure is dermal and
  for which the assumption of 100 percent absorption does not produce an adequate margin of safety. Registrants should work closely with the Agency in developing an acceptable protocol and
  performing dermal absorption studies.

[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993, 
15999, May 4, 1988; 58 FR 34203, June 23, 1993]



Sec. 158.390

Sec.  158.390  Reentry protection data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the reentry protection data requirements and the
substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                     Test substance
                                          -------------------------------------------------------------------------------------------------------------------------------------------- Guideline
     Kind of data required      (b) Notes        Terrestrial               Aquatic               Greenhouse                                                                            reference
                                          -----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support     No.
                                            Food crop    Nonfood    Food crop    Nonfood    Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foliar dissipation............        (1)  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      132-1
Soil dissipation..............   (1), (4)  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      132-1
Dermal exposure...............  (1), (2),  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      133-3
                                      (3)
Inhalation exposure...........  (1), (2),  CR          CR          CR          CR          ..........  .........  CR         .........  .........  TEP.............  TEP.............      133-4
                                      (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end-use product.
(b) Notes.-- The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required if the following conditions are met:
(i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or
(B) The acute inhalation toxicity of the technical grade of active ingredient is less than 200 mg/m \3\ (for a one-hour exposure); or
(C) The acute oral toxicity of the technical grade of active ingredient is less than 50 mg/kg (body weight); or
(D) Neurotoxic, teratogenic, or oncogenic effects or other adverse effects as evidenced by subchronic, chronic, and reproduction studies would be expected from entry of persons into treated
  sites; or
(E) The Agency receives other scientifically validated toxicological or epidemiological evidence that a pesticide or residue of a pesticide could cause adverse effects on persons entering
  treated sites. In the last situation, reentry intervals and supporting data may be required on a case-by-case basis.
(ii) And if: end-use product is to be registered for:
(A) Application to growing crops, such as to or around horticultural and agronomic crops that are field- or orchard-grown.

[[Page 103]]

 
(B) Application to outdoor tree nursery and forestry operations.
(C) Application to turf crops and commercial applications to turf.
(D) Application to parks and arboretums; or (E) application to aquatic crops.
(iii) And if: human exposure to residues of the pesticide can be reasonably foreseen. This applies primarily to pesticides that will be used on crops where human tasks will involve substantial
  exposure to residues of the pesticide.
(2) Data required if appropriate surrogate data are not available.
(3) Data required if the applicant chooses to use the allowable exposure level method for proposal of a reentry interval.
(4) Soil dissipation data required if agricultural practice involves human tasks that would cause substantial exposure to residues sorbed to soil.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]



Sec. 158.440

Sec.  158.440  Spray drift data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the aerial spray drift data requirements and the
substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Droplet size spectrum.........        (1)  CR          CR          CR          CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       201-1
Drift field evaluation........        (1)  CR          CR          CR          CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       202-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end use product.
(b) Notes.-- The following are referenced in column two of the table contained in paragraph (a) of this section.
(1) This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental
  effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This
  requirement may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
(2) [Reserved]

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]



Sec. 158.490

Sec.  158.490  Wildlife and aquatic organisms data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
wildlife and aquatic organisms data requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food Crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian and mammalian testing
 
Avian oral LD50 (preferably           (1)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        71-1
 mallard or bobwhite).

[[Page 104]]

 
Avian dietary LC50 (preferably        (1)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        71-2
 mallard and bobwhite).
Wild mammal toxicity..........        (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        71-3
Avian reproduction (preferably        (3)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        71-4
 mallard and bobwhite).
Simulated and actual field            (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............        71-5
 testing--mammals and birds.
 
   Aquatic organism testing
 
Freshwater fish LC50             (1), (7)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        72-1
 (preferably rainbow and
 bluegill).
Acute LC50 freshwater            (1), (7)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............        72-2
 invertebrates (preferably
 Daphnia).
Acute LC50 estuarine and         (4), (7)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-3
 marine organisms.
Fish early life stage and             (5)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-4
 aquatic invertebrate life-
 cycle.
Fish--life-cycle..............        (6)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............        72-5
Aquatic organism accumulation.        (8)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI, PAI, or     TGAI, PAI, or           72-6
                                                                                                                                                   degradation       degradation
                                                                                                                                                   product.          product.
Simulated or actual field             (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP               TEP                     72-7
 testing--aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditonally required; [  ]=Brackets (ie. [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought; TGAI=Techical grade of the
  active ingredient; TEP=Typical end-use product; PAI=``Pure'' active ingredient.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1)(i) Data are required as follows to support manufacturing use products and those end-use products for indoor use for which there is no registered manufacturing use product:
(A) Solid formulation indoor use products require avian oral LD50 (bobwhite), avian dietary LC50 (bobwhite), freshwater fish LC50 (rainbow trout) and acute LC50 freshwater invertebrate
  (Daphnia).
(B) Liquid formulation indoors use products require all tests listed under (b)(1)(i) of this section except the avian oral LD50.
(ii) Data are not required to support:
(A) Indoor end-use products consisting of a gas/highly volatile liquid or a highly reactive solid.
(B) Indoor end-use products for which there is a manufacturing use product registration.
(2) Tests required on a case-by-case basis depending on the results of lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate
  characteristics.
(3) Data required if one or more of the following criteria are met:

[[Page 105]]

 
(i) Birds may be subjected to repeated or continued exposure to the pesticide or any of its major metabolite degradation products, especially preceding or during the breeding season.
(ii) The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in avian feed.
(iii) The pesticide or any of its major metalolites or degradation products is stored or accumulated in plant animal tissues, as indicated by its octanol/water partition coefficient,
  accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
(iv) Any other information, such as that derived from mammalian reproduction studies that indicates the reproduction in terrestrial vertebrates may be adversely affected by the anticipated use
  of the pesticide product.
Note: Prior to conducting this test to support the registration of an avicide, the applicant should consult the Agency.
(4) Data required if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations
  because of its expected use or mobility pattern.
(5) Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever species is most sensitive to the pesticide as determined from the results of the acute
  toxicity tests) are required if the product is applied directly to water or expected to be transported to water from the intended use site, and when any one or more of the following
  conditions apply:
(i) If the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity.
(ii) If any LC 50 or EC 50 value determined in acute toxicity testing is less than 1 mg/l; or
(iii) If the estimated environmental concentration in water is equal to or greater than 0.01 of any EC 50 or LC 50 determined in acute toxicity testing.
(iv) If the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any EC50 or LC50 determined in acute toxicity testing and any of the following
  conditions exist:
(A) Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
(B) Physiochemical properties indicate cumulative effects.
(C) The pesticide is persistent in water (e.g., half-life in water greater than 4 days).
(6) Data are required if end-use product is intended to be applied directly to water or expected to transport to water from the intended use site, and when any of the following conditions
  apply:
(i) if the estimated environmental concentration is equal to or greater than one-tenth of the no-effect level in the fish early life-stage or invertebrate life-cycle test.
(ii) If studies of other organisms indicate the reproductive physiology of fish may be affected. NOTE: The applicant should consult the Agency prior to these tests to support the registration
  of a pesticide.
(7) Data from testing with the applicant's end-use product or a typical end-use product is required to support the registration of each end-use product which meets any one of the following
  conditions:
(i) The end-use pesticide will be introduced directly not an aquatic environment when used as directed.
(ii) The LC50 or EC50 of the technical grade of active ingredient is equal to or less than the maximum expected environmental concentration (MEEC) or the estimated environmental concentration
  (EEC) in the aquatic environment when the end-use pesticide is used as directed.
(iii) An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
  organisms.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]



Sec. 158.540

Sec.  158.540  Plant protection data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
plant protection data requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Target area phytotoxicity.....        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  EP..............  EP..............       121-1
Nontarget area phytotoxicity..
Tier I:
    Seed germination/seedling         (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-1
     emergence.
    Vegetative vigor..........        (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-1

[[Page 106]]

 
    Aquatic plant growth......        (2)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............       122-2
Tier II:
    Seed germination/seedling         (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-1
     emergence.
    Vegetative vigor..........        (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-1
    Aquatic plant growth......        (4)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TGAI............  TGAI............       123-2
Tier III:
    Terrestrial field.........        (3)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       124-1
    Aquatic field.............        (4)  ..........  CR          ..........  CR          .........  .........  CR         .........  .........  TEP.............  TEP.............       124-2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TGAI=Technical grade of the active ingredient; EP=End-use product; TEP=Typical end-use product.
(b) Notes.-- The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required for Special Review and certain public health situations.
(2) Data are required for pesticides to be used in forests and natural grasslands. For herbicide used in forest site preparation; the acquatic plant growth tests will be required. Data are
  required to support products to be used in other locations when any of the following conditions are met:
(i) Phytotoxicity problems concerning the product arise and open literature data are not available to address the problems.
(ii) The product may pose hazards to endangered or threatened species.
(iii) Special Review has been initiated on the product.
(3) Required if a 25 percent or greater detrimental effect was found in 1 or more plant species in the corresponding test of the previous tier.
(4) Required if a 50 percent or greater detrimental effect was found on any plant species in the corresponding test of the previous tier.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]



Sec. 158.590

Sec.  158.590  Nontarget insect data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
nontarget insect data requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use pattern                                                     Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget insect testing--
          pollinators
 
Honey bee acute contact LD50..        (1)  [CR]        [CR]        [CR]        [CR]        .........  .........  [CR]       [CR]       .........  TGAI............  TGAI............       141-1
Honey bee--toxicity of           (1), (2)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............       141-2
 residues on foliage.
Honey bee subacute feeding            (3)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       141-4
 study.
Field testing for pollinators.        (4)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............       141-5
 

[[Page 107]]

 
  Nontarget insect testing--
        aquatic insects
Acute toxicity to aquatic             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-1
 insects.
Aquatic insect life-cycle             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-1
 study.
Simulated or actual field             (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       142-3
 testing for aquatic insects.
Nontarget insect testing--            (5)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................       143-1
 predators and parasites.                                                                                                                                                                   thru
                                                                                                                                                                                           143-3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; [  ]=Brackets (ie, [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; TGAI=Technical grade of the
  active ingredient; TEP=Typical end-use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Required only if proposed use will result in honey bee exposure.
(2) Required only when formulation contains one or more active ingredients having an acute LD50 of less than 1 microgram/bee.
(3) This requirement is reserved pending development of test methodology.
(4) May be required under the following conditions:
(i) Data from the honey bee subacute feeding study indicate adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.).
(ii) Data from residual toxicity studies indicate extended residual toxicity.
(iii) Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute toxicity, such as the ability to cause reproductive or chronic effects.
(5) This requirement is reserved pending further evaluation to determine what and when data should be required, and to develop appropriate test methods.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]



Sec. 158.640

Sec.  158.640  Product performance data requirements.
 
  (a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
product performance data requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (b) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
   Efficacy of antimicrobial
            agents
 
Products for use on hard              (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-2
 surfaces.
Products requiring                    (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-3
 confirmatory data.
Products for use on fabrics           (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-4
 and textiles.
Air sanitizers................        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-5
Products for control of               (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-7
 microbial pests associated
 with human and animal wastes.

[[Page 108]]

 
Products for treating water           (1)  ..........  ..........  [CR]        ..........  .........  .........  .........  .........  CR         ................  EP*.............        91-8
 systems.
 
  Efficacy of fungicides and
          nematicides
 
Products for control of               (1)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  ................  EP*.............       93-16
 organisms producing
 mycotoxins.
 
Efficacy of Vertebrate Control
            Agents
 
Avian toxicants...............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............        96-5
Avian repellents..............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............        96-6
Avian frightening agents......        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............        96-7
Bat toxicants and repellents..        (1)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  (R)......  ................  EP*.............        96-9
Commensal rodenticides........        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  TEP.............  EP*.............       96-10
Rodenticides on farm and              (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............       96-12
 rangelands.
Rodent fumigants..............        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............       96-13
Rodent reproductive inhibitors        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  (R)......  ................  EP*.............       96-16
Mammalian predacides..........        (1)  (R).......  (R).......  ..........  ..........  .........  .........  .........  (R)......  .........  ................  EP*.............       96-17
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; [  ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; EP=End-use
  product* (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must satisfy, provided that their active ingredient(s) is (are) purchased from a
  registered source); MP=Manufacturing use product; TEP=Typical end-use product.
(b) Notes: The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose
  presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates
  (such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are
  efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of
  efficacy data for any pesticide product registered or proposed for registration.
(2) [Reserved]

[49 FR 42881, Oct. 24, 1984, as amended at 50 FR 46766, Nov. 13, 1985. 
Redesignated at 53 FR 15993, May 4, 1988, and amended at 58 FR 34203, 
June 23, 1993]



Sec. 158.690

Sec.  158.690  Biochemical pesticides data requirements.
 
  (a) Biochemical pesticide product analysis data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the biochemical pesticides--product analysis data
requirements and the substance to be tested.
 


[[Page 109]]


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity                .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      151-10
Manufacturing process.........        (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-11
Discussion of formation of           (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-12
 unintentional ingredients.
Analysis of samples...........      (iii)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI.....  EP* and TGAI....      151-13
Certification of limits.......  .........  [R]         R           [R]         R           [R]        R          R          R          R          MP..............  EP*.............      151-15
Analytical methods............  .........  R           R           R           R           R          R          R          R          R          MP..............  EP*.............      151-16
Physical and chemical           .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-17
 properties.
Submittal of samples..........       (iv)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI, PAI  EP*, TGAI and         151-18
                                                                                                                                                                     PAI.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required CR=Conditionally required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
  satisfy, provided that their active ingredient(s) (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [  ]=Brackets (i.e., [R], [CR]) indicate data
  requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under full scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
  information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
  case-by-case basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.



  (b) Biochemical pesticides residue data requirements. (1) Table. Sections 158.50 and 158.100 though 158.102
describe how to use this table to determine the biochemical pesticides--residue data requirements and the
substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity.............       (i),  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       TGAI............  TGAI............       153-3
                                    (ii),
                                    (xiv)
Directions for use............       (i),  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       ................  ................       153-3
                                   (iii),
                                    (xiv)
Nature of the residue:
    Plants....................       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       .........  PAIRA...........  PAIRA...........       153-3
                                    (xiv)
    Livestock.................       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       .........  PAIRA and plant   PAIRA and plant        153-3
                                    (iv),                                                                                                          metabo- lites.    metabo- lites.
                                    (xiv)

[[Page 110]]

 
Residue analytical method.....  (i), (v),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       .........  TGAI and metabo-  TGAI and metabo-       153-3
                                    (xiv)                                                                                                          lites.            lites.
Magnitude of the residue:
    Crop field trials.........       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  [CR]       .........  TEP.............  TEP.............       153-3
                                    (xiv)
    Processed food/feed.......  (i), (vi)  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  EP..............  EP..............       153-3
    Meat/mild/poultry/eggs....       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  [CR]       TGAI or plant     TGAI or plant          153-3
                                    (vii)                                                                                                          metabo- lites.    metabo- lites.
    Potable water.............       (i),  ..........  ..........  [CR]        [CR]        .........  .........  .........  .........  .........  EP..............  EP..............       153-3
                                   (viii)
    Fish......................  (i), (ix)  ..........  ..........  [CR]        [CR]        .........  .........  .........  .........  .........  EP..............  EP..............       153-3
    Irrigated crops...........   (i), (x)  ..........  ..........  [CR]        [CR]        .........  .........  .........  .........  .........  EP..............  EP..............       153-3
    Food handling.............  (i), (xi)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  [CR]       EP..............  EP..............       153-3
Reduction of residue..........       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  Residue of        Residue of             153-3
                                    (xii)                                                                                                          concern.          concern.
Proposed tolerance............       (i),  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  Residue of        Residue of             153-3
                                   (xiii)                                                                                                          concern.          concern.
Reasonable grounds in support   .........  [CR]        ..........  [CR]        ..........  [CR]       .........  .........  .........  .........  ................  ................       153-3
 of the petition.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; TEP=typical end-use product, MP=Manufacturing-use product; [
  ]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue chemistry data requirements shall apply to biochemical pesticide products when any one or more of the following conditions apply:
(A) Tier II or III toxicology data are required, as specified for biochemical agents in (c)(1) of this section.
(B) The application rate of the product exceeds 0.7 ounces (20 grams) active ingredient per acre per application.
(C) The application rate of the product exceeds a level determined to be comparable to 0.7 ounces active ingredient per application but the application rate is not expressable in terms of
  ounces per acre per application.
(ii) The same chemical identity data as required in (a)(1) of this section are required, with emphasis on impurities that could constitute a residue problem.
(iii) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(iv) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(v) A residue method suitable for enforcement of tolerances is needed whenever a numeric tolerance is proposed Exemptions from the requirement of a tolerance will also usually require an
  analytical method.
(vi) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
  tolerance.
(vii) Livestock feeding studies are required whenever a pesticide occurs as a residue in an livestock feed. Direct application to livestock uses will require animal treatment residue studies.
(viii) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
  for drinking purpose, by man or animals.
(ix) Data on residues in fish are required whenever a pesticide is to be applied directly to water.
(x) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
  ditches.
(xi) Data or residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments.
(xii) Reduction of residue data are required when the assumption of tolerance level residues results in an unsafe level of exposure. Data on the level of residue in food as consumed will be
  used to obtain a more precise estimate of potential dietary exposure.
(xiii) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry/eggs.
(xiv) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerances were
  established.



[[Page 111]]


  (c) Biochemical pesticides toxicology data requirements--(1) Table. Sections 158.50 and 158.100 through
158.102 describe how to use this table to determine the biochemical pesticides--toxicology data requirements
and the substances to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Acute oral toxicity.......        (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-10
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
    Acute dermal toxicity.....  (i), (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-11
                                                                                                                                                                     dilution* and
                                                                                                                                                                     TGAI.
    Acute inhalation..........      (xiv)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      152-12
    Primary eye irritation....       (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP..............      152-13
    Primary dermal irritation.  (i), (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP..............      152-14
    Hypersensitivity study....      (iii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         MP..............  EP..............      152-15
    Hypersensitivity incidents       (iv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  ................      152-16
    Studies to detect                 (v)  [R]         [CR]        [R]         [CR]        [R]        [CR]       [CR]       [CR]       [CR]       TGAI............  TGAI............      152-17
     genotoxicity.
    Immune response...........  .........  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............      152-18
    90-day feeding (1 spp.)...       (vi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-20
    90-day dermal (1 spp.)....      (vii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-21
    90-day inhalation (1 spp.)     (viii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-22
    Teratogenicity (1 spp.)...       (ix)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-23
Tier II:
    Mammalian mutagenicity            (x)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-19
     tests.
    Immune response...........       (xi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-24
Tier III:
    Chronic exposure..........      (xii)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      152-26
    Oncogenicity..............     (xiii)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      152-29
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally Required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must
  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [  ]=Brackets (i.e., [R], [CR]] indicate data
  requirement that apply when an experimental use permit is being sought.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Not required if test material is a gas or is highly volatile.

[[Page 112]]

 
(ii) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified toxicity category I on the basis of potential eye and
  dermal irritation effects.
(iii) Required if repeated contact with human skin results under condition of use.
(iv) Incidents must be reported, if they occur.
(v) Required to support non-food uses if use is likely to result in significant human exposure; or the active ingredient or its metabolites is (are) structurally related to a known mutagen, or
  belongs(s) to any chemical class of compounds containing known mutagens.
(vi) Required if the use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires a food additive regulation; or the use of the product is otherwise
  likely to result in repeated human exposure by the oral route.
(vii) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable prolonged human exposure to the product, (e.g., swimming pool algaecides,
  pesticides for impregnating clothing), and if either of the following criteria are met:
(A) Data from a subchronic oral study are not required.
(B) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is
  the toxic moiety.
(viii) Required if pesticidal use may result in repeated inhalation exposure at a concentration which is likely to be toxic.
(ix) Required if any of the following criteria are met:
(A) Use of the product under widespread and recognized practice may reasonably be expected to result in significant exposure to female humans.
(B) Its use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires issuance of a food additive regulation.
(x) Required if results from any one of the Tier I mutagenicity tests were positive.
(xi) Required if adverse effects are observed in the Tier I immune response studies.
(xii) Required if the potential for adverse chronic effects are indicated based on:
(A) The subchronic effect levels established in the Tier I subchronic oral toxicity studies, the Tier I subchronic dermal toxicity studies or the Tier I subchronic inhalation toxicity studies.
(B) The pesticide use pattern (e.g., rate, frequency, and site of application).
(C) The frequency and level of repeated human exposure that is expected.
(xiii) Required if the product meets either of the following criteria:
(A) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia)
  in any organ that potentially could lead to neoplastic change.
(B) If adverse cellular effects suggesting oncogenic potential are observed in Tier I or Tier II immune response studies or in Tier II mammalian mutagenicity assays.
(xiv) Required if the product consists of, or under conditions of use results in, an inhalable material (e.g., gas, volatile substance, or aerosol/particulate).



  (d) Nontarget organism, fate and expression data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the biochemical pesticides non-target organism,
fate and expression data requirements and substances to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Avian acute oral..........  (i), (ii)  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............       154-6
    Avian dietary.............       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............       154-7
                                    (ii),
                                     (vi)
    Freshwater fish LC50......       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............       154-8
                                (ii), (v)
    Freshwater invertebrate          (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............       154-9
     LC50.                          (ii),
                                    (vii)
    Nontarget plant studies...      (iii)  ..........  R           ..........  R           .........  .........  R          .........  .........  TGAI............  TGAI............      154-10
    Nontarget insect testing..  (iv), (v)  CR          CR          CR          CR          CR         CR         CR         CR         .........  TGAI............  TGAI............      154-11
Tier II:
    Volatility................     (viii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............       155-4

[[Page 113]]

 
    Dispenser-water leaching..       (ix)  CR          CR          CR          CR          .........  .........  CR         CR         .........  EP..............  EP..............       155-5
    Adsorption-desorption.....        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       155-6
    Octanol/Water Partition...        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       155-7
    U.V. absorption...........       (xi)  CR          CR          CR          CR          .........  .........  CR         CR         .........  PAI.............  PAI.............       155-8
    Hydrolysis................        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       155-9
    Aerobic soil metabolism...        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      155-10
    Aerobic aquatic metabolism        (x)  CR          CR          CR          CR                     .........  CR         CR         .........  TGAI............  TGAI............      155-11
    Soil photolysis...........        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      155-12
    Aquatic photolysis........        (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      155-13
Tier III:
    Terrestrial wildlife            (xii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       15-12
     testing.
    Aquatic animal testing....     (xiii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-13
    Nontarget plant studies...      (xiv)  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  TGAI............  TGAI............      154-14
    Nontarget insect testing..       (xv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-15
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally reguired; [  ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
  MP=Manufacturing-use product; TEP=Typical end-Use product; TGAI=Technical grade of the active ingredient; EP=End-use product, PAI=``Pure'' active ingredient.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies: rainbow trout for freshwater fish studies; and Daphnia for freshwater invertebrate
  studies on biochemicals.
(iii) Data are required for pesticides to be used in forests and natural grasslands. For herbicides used in forest site preparation; the aquatic plant growth tests will be required. Data are
  required when to support products to be used in other locations when any of the following conditions are met.
(A) Phytotoxicity problems arise and open literature data are not available.
(B) The product may pose hazards to endangered or threatened species.
(C) A rebuttable presumption against registration Special Review has been initiated on the product.
(iv) Required depending on pesticide mode of action and results of any available product performance data.
(v) Biochemicals introduced directly into an aquatic environment when used as directed shall be tested as specified in Sec.  158.145.
(vi) Not required if pesticide is highly volatile (estimated volatility greater than 5 x 10-5 atm. m3/mol).
(vii) If the pesticide will be introduced directly into an aquatic environment when used as directed, then it must be tested as indicated in Sec.  158.145.
(viii) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land.
(ix) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land in a passive
  dispenser.
(x) Required on a case-by-case basis when results of Tier I tests indicate environmental fate data are needed.
(xi) Required when results of Tier I tests indicate potential adverse effects on beneficial insects and the intended route of exposure of the pesticide is through vapor phase contact.
(xii) Required if either of the following criteria are met:
(A) Environmental fate characteristics indicate that the estimated concentration of the biochemical pesticide in the terrestrial environment is equal to or greater than \1/5\ the avian dietary
  LC50 or the avian single dose oral LD50 (converted to ppm).
(B) The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian feed.
(xiii) Required if environmental fate characteristics indicate that the estimated environmental concentration of the biochemical agent in the aquatic environment is equal to or greater than
  0.01 of any EC50 or LC50 determined in testing required by Tier I aquatic tests.
(xiv) Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement will be determined by the Tier II environmental fate
  tests.
(xv) Required when results of Tier I tests indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]

[[Page 114]]



Sec. 158.740

Sec.  158.740  Microbial pesticides--Product analysis data requirements.
 
  (a) Microbial pesticides product analysis data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the microbial pesticides--product analysis data
requirements and the substance to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity manufacturing             [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      151-20
 process.
                                      (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-21
Discussion of formation of           (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-22
 unintentional ingredients.
Analysis of samples...........      (iii)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI.....  EP* and TGAI....      151-23
Certification of limits.......             [R]         R           [R]         R           [R]        R          R          R          R          MP..............  EP*.............      151-25
Analytical methods............             R           R           R           R           R          R          R          R          R          MP..............  EP*.............      151-25
Physical and chemical                      [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-26
 properties.
Submittal of samples..........       (iv)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI, PAI  EP* TGAI and PAI      151-27
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product: EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical grade of the active ingredient;  [  ]=Brackets (i.e., [R], [CR]) indicate data
  requirements that apply when an experimental use permit is being sought.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
  information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
  case-by-case basis. For pesticide in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
 AAA(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.



  (b) Microbial pesticides-residue data requirements--(1) Table. Sections 158.50 and 158.100 through 158.102
describe how to use this table to determine the microbial pesticides-residue data requirements and the
substances to be tested.
 


[[Page 115]]


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Residue data..................        (i)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       ................  ................       153-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; EP=End-use product; MP=Manufacturing-use product; [  ]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being
  sought.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue data requirements shall apply to microbial pesticides when Tier II or Tier III toxicology data are required, as specified for microbial pesticides in (c)(1) of this section.
(ii) [Reserved)



  (c) Microbial pesticides-toxicology data requirements--(1) Table. Sections 158.50 and 158.100 through
158.102 describe how to use this table to determine the microbial pesticides-toxicology data requirements and
the substances to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Acute oral................  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP*            152-30
                                                                                                                                                                     dilution and
                                                                                                                                                                     TGAI.
    Acute dermal..............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-31
                                                                                                                                                                     dilution and
                                                                                                                                                                     TGAI.
    Acute inhalation..........        (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-32
                                                                                                                                                                     Dilution* and
                                                                                                                                                                     TGAI.
    I.V., I.C., I.P. injection       (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............      152-33
    Primary dermal............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      152-34
    Primary eye...............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      152-35
    Hypersensitivity study....      (iii)  R           R           R           R           R          R          R          R          R          MP..............  EP*.............      152-36
    Hypersensitivity incidents       (iv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  ................      152-37
    Immune response...........  .........  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............      152-38
    Tissue culture............        (v)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............      152-39
Tier II:
    Acute oral................       (vi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         MP..............  EP*.............      152-40
    Acute inhalation..........      (vii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         MP..............  EP*.............      152-41
    Subchronic oral...........     (viii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-42
    Acute I.P., I.C...........       (ix)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-43
    Primary dermal............        (x)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  EP*.............      152-44
    Primary eye...............       (xi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  EP*.............      152-45

[[Page 116]]

 
    Immune response...........      (xii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-46
    Teratogenicity............     (xiii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-47
    Virulence enhancement.....      (xiv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-48
    Mammalian mutagenicity....       (xv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-49
Tier III:
    Chronic feeding...........      (xvi)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      152-50
    Oncogenicity..............     (xvii)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      151-51
    Mutagenicity..............    (xviii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-52
    Teratogenicity............      (xix)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-53
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product; EP*=End use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [  ]=Brackets (i.e., [R], [CR]) indicate data
  requirements that apply when an experimental use permit is being sought.
(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Required if 20 percent or more of the aerodynamic equivalent of the product (as registered or under conditions of use) is composed of particulates less than 10 microns in diameter.
(ii) Data required for products as follows:
(A) Intravenous (``IV'') infectivity study for bacterial, and viral agents;
(B) Intracerebral (``IC'') infectivity study for viral and protozoan agents; and
(C) Intraperitoneal (``IP'') infectivity study for fungal and protozoan agents.
(iii) Required if commonly recognized use practices will result in repeated human contact by inhalation or dermal routes.
(iv) Hypersensitivity incidents must be reported, if they occur.
(v) Data required for products whose active ingredient is a virus.
(vi) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the Tier I acute oral
  infectivity tests or the intraperitoneal or intracerebral injection test for protozoa.
(vii) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the comparable Tier I acute
  inhalation tests.
(viii) Required if there is evidence of survival, replication, infectivity, or persistence of the protozoan agent in the Tier I oral infectivity test.
(ix) Required if in Tier I acute oral infectivity testing, Tier I dermal toxicity/infectivity testing, or Tier I intraperitoneal or intracerebral injection testing, the test microorganism
  (bacteria, fungi, or protozoa) survived for more than 2 weeks, caused toxic effects, or caused a severe illness response in an experimental animal as evidenced by irreversible gross
  pathology, severe weight loss, toxemia, or death.
(x) Required if infectivity or if marked edema or broad erythema was observed in the Tier I dermal irritation study.
(xi) Required if infectivity or if severe ocular lesions are observed in the Tier I primary eye irritation study.
(xii) Required if results of the Tier I immune response test indicate abnormalities.
(xiii) Required when Tier I tests on viral agents show replication of the virus in mammalian hosts and significant damage to mammalian cells.
(xiv) Required when Tier I infectivity tests on bacteria or fungi indicate prolonged survival (including presence of viable microbial agents in test animal excreta) and/or multiplication
  (infectivity) of the bacteria or fungal agent, respectively.
(xv) Required if any of the following criteria are met:
(A) Acute infectivity tests are positive in Tier I studies.
(B) Adverse effects are observed in immune response studies.
(C) Positive results are obtained in tissue culture tests with viral agents.
(xvi) Required when the potential for chronic adverse effects (e.g., replication or persistence of viral or subviral constituents, protozoans, fungi, or bacteria) are demonstrated by any of
  the Tier II tests (except primary dermal, primary ocular, and mammalian mutagenicity tests).
(xvii) Required when the potential for oncogenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, or
  bacteria, fungi or protozoans; or mutagenic effects) by any of the Tier II tests except the primary dermal and primary ocular studies.
(xviii) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, bacteria,
  fungi or protozoa) by any of the Tier II tests except primary dermal or primary ocular studies.
(xix) Required when the potential for teratogenic effects is expected based on the presence of persistence of fungi, bacteria, viruses, or protozoa in mammalian species as a result of testing
  performed in Tier II, except primary dermal and primary ocular studies.



[[Page 117]]


  (d) Microbial pesticides non-target organism and environmental expression data requirements--(1) Table.
Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the microbial
pesticides non-target organism and environmental expression data requirements and substances to be tested.
 


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Avian oral................       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............      154-16
                                    (ii),
                                    (iii)
    Avian injection test......       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............      154-17
                                    (ii),
                                    (iii)
    Wild mammal testing.......       (iv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-18
    Freshwater fish testing...        (i)  [R]         [R]         [R]         [R]         CR         CR         [R]        CR         CR         TGAI............  TGAI............      154-19
    Freshwater aquatic                (i)  [R]         [R]         [R]         [R]         CR         CR         [R]        CR         CR         TGAI............  TGAI............      154-20
     invertebrate testing.
    Estuarine and marine              (v)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       154-2
     animal testing.
    Nontarget plant studies...  .........  [R]         [R]         [R]         [R]         .........  .........  [R]        [R]        CR         TEP.............  TEP.............       154-2
    Nontarget insect testing..  .........  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        .........  TGAI............  TGAI............      154-23
    Honey bee testing.........  .........  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        .........  TGAI............  TGAI............      154-24
Tier II:
    Terrestrial environmental        (vi)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-18
     testing.
    Freshwater environmental        (vii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-19
     expression tests.
    Marine or estuarine           (xiii),  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-20
     environmental expression        (ix)
     tests.
Tier III:
    Terrestrial wildlife and          (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      154-25
     aquatic organism testing.
    Avian pathogenicity/             (xi)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-26
     reproduction test.
    Definitive aquatic animal       (xii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-27
     tests.
    Aquatic embryo larvae and      (xiii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-28
     life cycle studies.
    Aquatic ecosystem test....      (xiv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-29

[[Page 118]]

 
    Special aquatic tests       .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-30
     (reserved).
    Nontarget plant studies...       (xv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TEP.............      154-31
Tier IV:                            (xvi)
    Simulated and actual field     (xiii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............      154-33
     tests (birds, mammals).
    Simulated and actual field    (xvii),  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............      154-34
     tests (aquatic organisms).   (xviii)
    Simulated and actual field  .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-35
     tests (insect predators,
     parasites) (reserved).
    Simulated and actual field  .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-36
     tests (insect
     pollinators) (reserved).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 AAAKey: R=Required; CR=Conditionally required; [  ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
  MP=Manufacturing-use Product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; EP=End-use product; PAI=``Pure'' active ingredient.
 AAA(2) Notes.-- The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
 AAA(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
 AAA(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies; rainbow trout for freshwater fish studies.
 AAA(iii) Data from either the avian acute oral or the avian injection study are required to support an experimental use permit.
 AAA(iv) Required on a case-by-case basis if results of tests required by paragraph (c)(1) of this section are inadequate or inappropriate for assessment of hazards to wild animals.
 AAA(v) Required when product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of
  expected use or mobility pattern.
 AAA(vi) Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
 AAA(A) Avian single dose oral toxicity and pathogenicity tests.
 AAA(B) Avian injection pathogenicity tests.
 AAA(C) Wild mammals toxicity and pathogenicity test.
 AAA(D) Plant studies--terrestrial.
 AAA(E) Honey bee toxicity/pathogenicity test.
 AAA(F) Testing for toxicity/pathogenicity to insect predators and parasites.
 AAA(vii) Required when toxic or pathogenic effects are observed in any of the following Tier I test for microbial pest control agents:
 AAA(A) Freshwater fish toxicity and pathogenicity testing.
 AAA(B) Freshwater aquatic invertebrate toxicity and pathogenicity test.
 AAA(C) Plant studies--aquatic.
 AAA(viii) Required if product is applied on land or in fresh water and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
 AAA(A) Estuarine and marine animal toxicity and pathogenicity test.
 AAA(B) Plant studies--estuarine or marine.
 AAA(ix) Required if product is applied in marine or estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests:
 AAA(A) Avian single dose oral toxicity and pathogenicity test.
 AAA(B) Avian injection pathogenicity test.
 AAA(C) Estuarine and marine animal toxicity and pathogenicity test.

[[Page 119]]

 
 AAA(x) Required when toxic effects on nontarget terrestrial wildlife or aquatic organisms are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the
  mocrobial agent to the affected nontarget terrestrial wildlife or aquatic organisms.
 AAA(xi) Required when:
 AAA(A) Pathogenic effects are observed in Tier I avian tests at a level equal to the adjusted host equivalent amount.
 AAA(B) Chronic, carcinogenic, or teratogenic effects are reported in tests required by paragraph (c)(1) of this section for evaluating hazard to humans and domestic animals.
 AAA(C) Tier II Environmental expression testing indicates that exposure of terrestrial animals to the microbial agent is likely.
 AAA(xii) Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I
  tests.
 AAA(xiii) Required when both of the following conditions are met:
 AAA(A) Pathogenic effects at actual or expected field residue exposure levels are reported in Tier III.
 AAA(B) The agency determines that quarantine methods will prevent the microbial pest control agent from contaminating areas adjacent to the test area.
 AAA(xiv) Required if, after an analysis of the microbial agent's properties, the individual use patterns, and the results of previous nontarget organism and environmental expression tests, it
  is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments, including those of the water column and bottom sediments. When
  a microbial pest control agent is used in or is expected to transport to water from the intended use site, major considerations for requiring these infectivity tests include, but are not
  limited to:
 AAA(A) Infectivity or pathogenicity demonstrated in previous testing.
 AAA(B) Viability of the microorganism in natural waters as demonstrated in Tier II tests.
 AAA(xv) Required if the product is transported from the site of application by air, soil, or water or transmission by other animals. The extent of movement will be determined by the
  environmental expression tests in Tier II.
 AAA(xvi) The Agency expects that Tier IV requirements would be imposed retrospectively--after product registration as post registration monitoring, since it is unlikely a registrant would
  pursue registration of a microbial agent posing potential hazards such that testing beyond Tier III is required.
 AAA(xvii) Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of
  available laboratory data, use patterns, and exposure rates.
 AAA(xviii) Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and
  growth of natural populations are observed) are required if laboratory data indicate adverse long-term, cumulative, or life-cycle effects may result from intended use.

[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]

[[Page 120]]

Appendix A to Part 158--Data Requirements for Registration: Use Pattern 
                                  Index

How to use this Index:
    1. Identify the Pesticide Use Site Group listed below (e.g., 
agricultural crops, forests, ornamental plants) that covers the specific 
use pattern of interest to you.
    2. Find your specific use pattern under the appropriate Pesticide 
Use Site Group.
    3. Identify the general use pattern that corresponds to your 
specific use pattern.
    4. Use the general use pattern in determining applicable data 
requirements on the Data Requirements tables presented in Secs. 158.120 
through 153.170.
Pesticide use site group
    1. Agricultural Crops.
    2. Ornamental Plants and Forest Trees.
    3. General Soil Treatment and Composting.
    4. Processed or Manufactured Products, and food or feed containers 
or dispensers.
    5. Pets and Domestic Animals.
    6. Agricultural Premises and Equipment.
    7. Household.
    8. Wood or Wood Structure Protection Treatments.
    9. Aquatic sites.
    10. Noncrop, wide area, and general indoor/outdoor treatments.
    11. Antifouling treatments.
    12. Commercial and Industrial Uses.
    13. Domestic and Human Use.
    14. Miscellaneous Indoor Uses.

------------------------------------------------------------------------
 Specific use patterns--listed according to    Corresponding general use
               use site group                           pattern
------------------------------------------------------------------------
            1. Agricultural crops
Small fruits                                  Terrestrial food crop
  Caneberries (e.g., raspberry, dewberry)
  Bushberries (e.g., blueberry, currant)
  Vine fruits (e.g., grape, kiwi fruit)
  Strawberry
  Cranberry
  Pome fruits (e.g., apple, quince)
  Stone fruits (e.g., peach, cherry)
  Nut crops--tree & shrub (e.g., pecan,
   filbert)
  Other temperate fruits (e.g., persimmon,
   pawpaw)
Tropical and subtropical fruits
  Citrus
  Banana and plantain
  Palm fruits and nuts (e.g., date, coconut)
  Pineapple
  Other fruits and nuts
Beverage crops
  Woody--cocoa, coffee, tea
  Herbaceous--chicory, mint
Flavoring and spice crops
  Woody--leaf/stem, root, seed and pod
  Herbac.--leaf/stem, root, seed and pod
Vegetables--leaf/stem, root, seed and pod,
 fruiting vegetables, cucurbits
  Commercial annual (e.g., tomato, bean)
  Commercial perennial (e.g., asparagus,
   rhubarb)
Greenhouse (commercial)                       Greenhouse food crop
  Mushrooms
  Nursery/seed crop/medical crop/tobacco      Greenhouse non-food crop
Fiber crops                                   Terrestrial food crop
  Cotton
  Others--(e.g., flax)
Forage crops
  Typical grasses--annual (e.g., sudan
   grass)
  Typical grasses--perennial (e.g.,
   bromegrass)
  Corn and sorghum
  Small grains for forage (e.g., rye)
  Perennial legumes (e.g., white clover)
Annual legumes (e.g., crotalaria, soybean)
Crop harvest residue (peanut vines, beet
 tops, etc.)
Grain and edible seed crops
  Corn
  Rice                                        Aquatic food crop
  Wheat, barley, rye, oats                    Terrestrial food crop
  Sorghum
  Alfalfa
  Other grains
  Other nongrains (e.g., squash, pumpkin)
  Buckwheat
  Sesame
  Peanut
  Sunflower
Seed sprout crops
  Mung bean, red clover, soybean, alfalfa,
   etc.
  Nonlegume crops (e.g., wheat, radish,
   black mustard)
Crops grown exclusively for seed for
 planting
Sugar crops
Stored raw agricultural commodities           Indoor
  Honey (principal nectar-producing crops)
  Sugar beet
  Sugar cane
  Sugar maple
  Sorghum (for sugar)
Crops for smoking and chewing                 Terrestrial nonfood crop
    --field
    --shade
    --storage
    --greenhouses
  Sapodilla (for chewing gum)                 Terrestrial food crop
Oil crops
  Annual herbaceous crops
  Perennial herbaceous crops
  Tropical/subtropical woody crops
Drug and medicinal crops                      Terrestrial nonfood crop
  Annual herbaceous crops
  Perennial herbaceous crops
  Temperate woody crops
  Tropical/subtropical wood crops

[[Page 121]]

 
    2. Ornamental plants and forest trees
Ornamental plants                             Terrestrial nonfood crop
  Annual garden plants
  Temperate perennial nonfood garden herbs
  Commercial greenhouse crops                 Greenhouse nonfood crop
  Houseplants                                 Indoor
  Home and retail greenhouse and
   conservatory plants
  Public display plantings                    Terrestrial nonfood crop
  Bulb, corm, and tuber ornamentals
  Subtropical/tropical garden evergreen
   plants (dry--e.g., agave)
  Subtropical/tropical garden evergreen
   plants (moist--e.g., ferns)
  Groundcovers
  Aquatic plants (e.g., waterlilies)          Aquatic nonfood use
Ornamental trees, shrubs, and vines (woody)   Terrestrial nonfood crop
  Deciduous temperate broadleaf
  Evergreen temperate broadleaf
  Deciduous temperate conifer
  Evergreen temperate conifer
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
  Tropical/subtropical miscellaneous (e.g.,
   cycad, tree fern, bamboo)
Lawn and turf grasses--ornamental             Terrestrial nonfood crop
                                               or domestic outdoor
  Cool season Winter grasses (bent,
   bluegrass, fescue, etc.)
  Summer grasses (zoysia, bermudagrass,
   etc.)
  Ornamental bunch grasses (pampasgrass,
   blue fescue)
Forest trees--nonornamental--trees forests,   Forestry
 plantings
  Deciduous temperate (broadleaf)
  Evergreen temperate (broadleaf)
  Deciduous and evergreen conifers
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
Forest tree nurseries--Temperate broadleaf
 trees
  Temperate conifer trees
Forest trees: dead trees/logs/stumps in the
 forest or in plantings
  3. General soil treatment and composting
General soil treatments                       Terrestrial nonfood crop
  Soil application with no mention of crops
   to be grown (potting soil, top soil).
  Manure
  Composts
  Cull piles
  Mulches
 4. Processed or manufactured products, and
    food or feed containers or dispensers
Processed vegetables, fruits, and nuts        Indoor
  Fruits
  Leafy vegetables
  Root vegetables
  Fruited vegetables
  Nuts
  Peanuts
  Seeds (sesame, sunflower)
Dried processed
  Fruits
  Vegetables
  Tobacco
  Beverages (tea, coffee)
  Herbs and spices
Animal Feeds
  Cattle (beef)
  Cattle (dairy)
  Goat (nondairy)
  Goat (dairy)
  Horse, mule, donkey
  Poultry (chicken, turkey, etc.)
  Sheep (meat)
  Sheep (wool)
  Swine
  Dog
  Cat
  Other pets (including birds)
  Fur-bearing stock
  Other meat-producing stock (e.g., rabbit)
  Fish food (commercial)
  Fish food (pet)
  Birdseed
Processed grain products for human
 consumption
  Corn
  Soybean
  Wheat
  Other grains (rice, barley, etc.)
  Cereal foods
  Flour
  Baked goods
  Farinaceous products
  Processed animal products for human
   consumption
  Cheese
  Egg yolks
  Meats, including fish and poultry
  Milk
Processed plant products for human
 consumption
  Chocolate
  Candy
  Sugar
  Yeast
  Citrus pulp
  Chewing gum
  Cigarettes, etc.
  Herbs and spices
  Pickles
  Glazed fruits
  Jellies
  Seed oils
  Fruit syrups (e.g., cola)
  Fruit juices
  Fermentation beverages (wine, beer,
   whiskey, vinegar)
  Processed or manufactured nonfood plant
   and animal products
  Textiles, fabrics, fibers
  Fur and hair products
  Leather products
Food and feed containers, dispensers, and
 processing equipment
  Airtight storages--large (empty/full)
  Airtight storages--small (empty/full)
  Fumigation chambers
  Bins
  Elevators
  Storage areas--(empty/full)

[[Page 122]]

 
  Processing or handling equipment and
   machinery (other than food processing)
  5. Pets and domestic animals--animals and
           their man-made premises
Dairy cattle--lactating                       Indoor
Dairy cattle--nonlactating
Dairy cattle--heifers, calves
Goats--lactating
Goats--nonlactating
Goats--young (kids)
Fur- and wool-bearing animals
  Goats
  Sheep
  Mink
  Chinchilla
  Rabbit
  Fox
  Nutria
Meat animals (mammals)
  Cattle (and calves)
  Goats (and kids)
  Horses
  Rabbits
  Sheep (and lambs)
  Swine
  Bison
  Reindeer
Poultry (meat, eggs)
  Chickens
  Turkeys
  Ducks, geese
  Guineas, pheasants, quail, etc.
Honey production
  Bees
  Beehives
  Honeycombs
Fish and shellfish production                 Aquatic food use
  Hatchery buildings
  Culture ponds, containers
Animals for labor, display, riding, racing,   Indoor
 lab use, etc.
  Dogs
  Horses, donkeys, mules
  Guinea pigs
  Mice
  Rats
  Gerbils
  Hamsters
  Monkeys
  Cats
  Chickens, birds
  Wild rodents
  Alfalfa leafcutting bee (pollinator)
  Alkaline bee (pollinator)
  Zoo ruminants
  Zoo ungulates
  Zoo canines
  Zoo felines
  Zoo primates
  Zoo reptiles
  Zoo amphibians
  Zoo birds
  Zoo--others
  Aquarium fish
Animals for pets, including their cages,
 bedding, nests, etc.
  Dogs
  Cats
  Birds
  Rodents
  Lagomorphs
  Fish
  Amphibians
  Reptiles
  Primates
  Other vertebrates
   6. Agricultural premises and equipment
Egg handling facilities and equipment         Indoor
  Egg washers
  Egg rooms
  Hatching egg treatments
  Hatching egg rooms
  Hatching egg equipment
  Egg packing plants and hatcheries
Milk handling facilities and equipment
  Milk storage rooms
  Milking stalls and parlors
  Milking machines, milk tanks, etc.
  Teat cups, liners, etc.
  Milk processing equipment
                7. Household
Non-food area and sites                       Indoor
  Closets, storage areas
  Basements, cellars
  Bedrooms
  Attics
  Recreation rooms
  Living rooms
  Baseboards, window sills, etc.
  Plumbing fixtures
  Sickrooms
Food-handling and food storage areas
  Kitchens
  Dining rooms
  Pantry and food storage shelving
Household contents and space
  Air
  Beds
  Rugs
  Book cases
  Furs, fabrics, blankets
  Play pens
  Sickroom utensils
  Filters for air vents, air conditioners,
   furnaces, etc.
Outdoor areas (Noncommercial homeowner use)   Domestic outdoor or
                                               terrestrial food crop
  Home garden, orchards
  Porches                                     Domestic outdoor
  Patios
  Foundations
  Steps
  Eaves
  Yards, lawn, turf
  Domestic ornamental plantings
    8. Wood or Wood Structure Protection
                 Treatments
Buildings (for termite, powderdust beetle     Domestic outdoor or indoor
 controls, etc.)
Unseasoned forest products
Seasoned forest products
Finished wood products
Wood pressure treatments
Plant-growing wood structures and containers
Wood containers for nonfood, nonfeed uses
              9. Aquatic sites
Food processing water systems                 Aquatic food crop
Poultry and livestock drinking water
Pulp and papermill systems                    Aquatic noncrop
Swimming pool water
Industrial disposal systems
Industrial ponds

[[Page 123]]

 
Human drinking water                          Aquatic food crop
Cooling water towers                          Aquatic noncrop
Agricultural irrigation water, and ditches    Aquatic food crop
Agricultural drainage water and ditches
Sewage systems and drainfields                Aquatic noncrop
Dishwashing water                             Indoor
Domestic and commercial nonpotable water      Aquatic noncrop
Lakes, ponds, impounded water
Streams, rivers, canals
Swamps, marshes, wetlands
Air conditioner water
  Humidifier water
Air washer water systems
Secondary oil recovery injection water
Heat exchange water system
Polluted water
Bait boards (floating--for vertebrate
 control)
Catch basins, puddles, tree holes
Estuaries, tidal marshes
Commercial and sport fish-bearing waters      Aquatic food crop
 10. Noncrop, wide area, and general indoor/
             outdoor treatments
Uncultivated agricultural areas (nonfood      Terrestrial noncrop
 producing)
  Farmyards
  Fuel storage areas
  Fence rows
  Rights-of-way
  Fallow land                                 Terrestrial food crop
  Soil bank land                              Terrestrial noncrop
  Barrier strips
Uncultivated nonagricultural areas (outdoor)
  Airports
Recreation areas, fairgrounds, race tracks,
 tennis courts, etc.
  Campgrounds
  Recreation area structures
  Highway rights-of-way
  Railroad rights-of-way
  Utility rights-of-way
  Sewage disposal areas
Industrial sites (lumberyards, tank farms,
 etc.)
Paved areas
  Private roads and walks
  Fencerows and hedgerows (nonagricultural)
Directed Pest Control to Pests' Nests, etc.,  Terrestrial noncrop or
 and for Traps                                 indoor
  Diseased beehives
  Nuisance bee nests
  Ant mounds, hills, dens
  Termite mounds
  Insect traps (chemical lures)
  Repellents and irritants to pests (when
   not covered by other sites)
Wide area and general indoor/outdoor
 treatments
  Rural areas (unspecified)
  Urban areas (unspecified)
  Public buildings and structures
  Animal burrow entrances, dens, tunnels
  Animal nests
  Animal trails
  Mammal feeding areas
  Nonagricultural areas for public health
   treatments
  Bird roosting, nesting areas
  Bird feeding areas
         11. Antifouling Treatments
Sites for marine exposures                    Aquatic noncrop
  Boat bottoms and other submersed
   structures
    Steel
    Fiberglass
    Aluminum
    Wood
    Plastic
    Other substances and materials
  Crab pots and lobster pots
Sites for fresh water exposures
Cooling tower influent conduits
     12. Commercial and Industrial Uses
Transportation Facilities                     Indoor
  Bus
  Truck and Trailer
  Containerized units
  Railroad cars
  Aircraft
  Ships/barges
  Auto, taxis
  Recreational vehicles
  Shipping containers
Food and feed processing plants
  Bakeries
  Bottlers
  Canneries
  Dairies, creameries, milk processing
   plants
  Feed mills, feed stores
  Fresh fruit packing and processing
  Meat processing
  Poultry processing
  Wineries, wine cellars
  Flour mills, machinery, warehouses, bins,
   elevators
  Egg processing
  Candy and confectionary plants
  Sugar processing, cane mills, etc.
  Cider mills
  Dry food products plants
  Tobacco processing
  Air treatment for processing and
   transportation of foods
  Beverage processing
  Nut processing
  Cereal processing
  Seafood processing
  Vegetable oil processing
  Spice mills
  Vinegar processing
  Farinaceous processing (noodles, etc.)
  Mushroom processing
  Dried fruit processing
  Pickle processing
  Ice plants
  Chocolate processing
  Fruit juice processing
Eating establishments (all)
  Food handling areas
  Food serving areas
  Eating establishment nonfood areas
  Air treatment for eating establishments
  Food storage equipment (coolers,
   refrigerators, etc.)
  Eating and serving utensils (spoons, etc.)
Food marketing, storage, and distribution

[[Page 124]]

 
  Food dispensing and vending equipment
  Food stores, markets, stands
  Meat and fish markets
  Food catering facilities
  Food marketing, storage, and distribution
   equipment and utensils
Hospitals and related institutions and
 facilities
  Critical premises (e.g., burn wards, etc.)
  Hospital patient premises (wards,
   emergency rooms, etc.)
  Noncritical premises (labs, lounges,
   lobbies, storage)
  Critical items (hypodermic needles, dental
   instruments, catheters, etc.)
  Noncritical items (bedpans, carpets,
   furniture, etc.)
  Air treatment (also to ambulances)
Janitorial equipment
Barber and beauty shop instruments and
 equipment
Morgues, mortuaries, and funeral homes
  Premises (embalming rooms, etc.)
  Equipment (tables, etc.)
  Instruments
  Burial vaults, mausoleums
  Air treatment
Commercial, institutional, and industrial
Maintenance, Buildings, and Structures
  Locker rooms, equipment
  Gyms, bowling alleys, and equipment
  Telephones and booths
  Shower rooms, mats, and equipment
  Cotton mill premises and equipment
  Auditoriums and stadiums
  Factories
  Rendering plants
  Loading areas, ramps
  School buildings and equipment
  Office buildings
  Laundries
Fuels from Crops (alcohol, methane)
  Fossil fuels (e.g., oils, jet fuel)
  Seed oils
  Paper
Pesticide materials preservation and
 protection
  Rodenticide baits (protection against
   insects)
  Dried plant parts (pyrethrum, red squill,
   rotenone, sabadilla)
  Paints
Preservatives and protectants
  Grains
  Hay, silage
  Adhesives
  Coatings (asphalt and lacquer)
  Fuels
  Leather and leather products
  Leather processing liquors
  Metalworking cutting fluids
  Oil recovery drilling muds and packer
   fluids
  Paints (latex)
  Paper and paper products
  Plastic products
  Resin emulsions
  Rubber (natural) products
  Specialty products (polishes, cleansers,
   dyes, etc.)
  Textiles, textile fibers, and cordage
  Wet-end additives, etc. (pulp sizing,
   alum, casein, printing pastes)
  Disposable diapers
  Wool, hair, mohair, furs, felt, feathers,
   etc.
  Electrical supplies, cables, and equipment
         13. Domestic and Human Use
Human Body and Hair                           Indoor
Fiber product protection (Moth,
    mildew-proofing)
  Clothing
  Upholstery
  Ornamental fabrics (draperies, tapestries)
  Ropes
  Sail cloth
Human articles and materials
  Bedding, blankets, mattresses
  (Treatments to) hair, body, clothing
   (while being worn)
  Clothing
  Face gear (goggles, face masks, etc.)
  Headgear (safety helmets, headphones,
   etc.)
  Wigs
  Contact lenses
  Dentures, toothbrushes, mouthpieces to
   musical instruments, etc.
  Brick, asbestos, etc.
  Wood surfaces
  Leather surfaces
  Fabric surfaces
  Paper/paperboard surfaces
Specialty uses
  Museum collectors (preserved animal and
   plant specimens)
  Military uses--not specified
  Quarantine uses--not specified
  DHHS/FDA uses--not specified
  Filters (air conditioning, air, and
   furnace)
  Biological specimens
  Underground cables
  Cuspidors, spittoons
  Vomitus
  Human wastes
  Air sanitizers
  Diapers
  Laundry equipment (carts, chutes, tables,
   etc.)
  Dust control--products and equipment
   (mops, etc.)
  Dry cleaning
  Carpets
  Upholstery
Bathrooms, toilets bowls, and related sites
  Bathroom premises
  Toilet bowls and urinals
  Toilet tanks
  Portable toilets, chemical toilets
  Vehicular holding tanks
  Bathroom air treatment
  Diaper pails
Refuse and soild waste
  Refuse and solid waste containers
  Refuse and solid waste transportation and
   handling equipment
  Garbage dumps
  Household trash compactors

[[Page 125]]

 
  Garbage disposal units, food disposals
  Incinerators
        14. Miscellaneous Indoor Uses
Surface Treatments                            Indoor
  Hard nonporous surfaces (painted, tile,
   plastic, metal, glass, etc.)
  Hard porous surfaces (cement, plaster)
  Camping equipment and gear
  Grooming instruments (brushes, clippers,
   razors, etc.)
Laundry, cleaning, and dry cleaning
------------------------------------------------------------------------



PART 159--STATEMENTS OF POLICIES AND INTERPRETATIONS--Table of Contents




Subparts A-C [Reserved]

     Subpart D--Reporting Requirements for Risk/Benefit Information

Sec.
159.152  What the law requires of registrants.
159.153  Definitions.
159.155  When information must be submitted.
159.156  How information must be submitted.
159.158  What information must be submitted.
159.159  Information obtained before promulgation of the rule.
159.160  Obligations of former registrants.
159.165  Toxicological and ecological studies.
159.167  Discontinued studies.
159.170  Human epidemiological and exposure studies.
159.178  Information on pesticides in or on food, feed, or water.
159.179  Metabolites, degradates, contaminants, and impurities.
159.184  Toxic or adverse effect incident reports.
159.188  Failure of performance information.
159.195  Reporting of other information.

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

    Source: 63 FR 49388, Sept. 19, 1997, unless otherwise noted.

Subparts A-C [Reserved]



     Subpart D--Reporting Requirements for Risk/Benefit Information



Sec. 159.152   What the law requires of registrants.

    (a) Section 6(a)(2) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) states: ``If at any time after the registration 
of a pesticide the registrant has additional factual information 
regarding unreasonable adverse effects on the environment of the 
pesticide, he shall submit such information to the Administrator.''
    (b) Section 152.50(f)(3) of this chapter requires applicants to 
submit, as part of an application for registration, any factual 
information of which he is aware regarding unreasonable adverse effects 
of the pesticide on humans or the environment, which would be required 
to be reported under section 6(a)(2) if the product were registered.
    (c) Compliance with this part will satisfy a registrant's 
obligations to submit additional information pursuant to section 6(a)(2) 
and will satisfy an applicant's obligation to submit additional 
information pursuant to Sec. 152.50(f)(3) of this chapter.



Sec. 159.153   Definitions.

    (a) For the purposes of reporting information pursuant to FIFRA 
section 6(a)(2), the definitions set forth in FIFRA section 2 and in 40 
CFR part 152 apply to this part unless superseded by a definition in 
paragraph (b) of this section.
    (b) For purposes of reporting information pursuant to FIFRA section 
6(a)(2), the following definitions apply only to this part:
    Established level means a tolerance, temporary tolerance, food 
additive regulation, action level, or other limitation on pesticide 
residues imposed by law, regulation, or other authority.
    Formal Review means Special Review, Rebuttable Presumption Against 
Registration (RPAR), FIFRA section 6(c) suspension proceeding, or FIFRA 
section 6(b) cancellation proceeding, whether completed or not.
    Hospitalization means admission for treatment to a hospital, clinic 
or other health care facility. Treatment as an out-patient is not 
considered to be hospitalization.
    Maximum contaminant level (MCL) means the maximum permissible level, 
established by EPA, for a contaminant in water which is delivered to any 
user of a public water system.
    Non-target organism means any organism for which pesticidal control 
was either not intended or not legally permitted by application of a 
pesticide.

[[Page 126]]

    Pesticide means a pesticide product which is or was registered by 
EPA, and each active ingredient, inert ingredient, impurity, metabolite, 
contaminant or degradate contained in, or derived from, such pesticide 
product.
    Qualified expert means one who, by virtue of his or her knowledge, 
skill, experience, training, or education, could be qualified by a court 
as an expert to testify on issues related to the subject matter on which 
he or she renders a conclusion or opinion. Under Rule 702 of the Federal 
Rules of Evidence, a person may be qualified as an expert on a 
particular matter by virtue of ``knowledge, skill, experience, training, 
or education.'' In general, EPA wants registrants to report information 
when a person has relevant expert credentials, e.g., a medical doctor 
giving a medical opinion, a plant pathologist giving an opinion on plant 
pathology, etc.
    Registrant includes any person who holds, or ever held, a 
registration for a pesticide product issued under FIFRA section 3 or 
24(c).
    Similar species means two or more species belonging to the same 
general taxonomic groups: The general taxonomic groups for purposes of 
this requirement are: mammals, birds, reptiles, amphibians, fish, 
aquatic invertebrates, insects, arachnids, aquatic plants (including 
macrophyte, floating, and submerged plants), and terrestrial (all non-
aquatic) plants.
    Water reference leve means the level specified in paragraph (1) or 
(2) of this definition, whichever is lower.
    (1) Ten percent of the maximum contaminant level (MCL) established 
by EPA, or if no MCL has been established by EPA, 10 percent of the most 
recent draft or final long-term health advisory level (HAL) established 
by EPA, or if EPA has not published or proposed an MCL or HAL, the 
lowest detectable amount of the pesticide.
    (2) The ambient water quality criteria for the protection of aquatic 
life, established by EPA pursuant to section 304(a) of the Clean Water 
Act.

[62 FR 49388, Sept. 19, 1997, as amended at 63 FR 33582, June 19, 1998]



Sec. 159.155   When information must be submitted.

    (a) The following reportable information must be received by EPA not 
later than the 30th calendar day after the registrant first possesses or 
knows of the information:
    (1) Scientific studies described in Sec. 159.165.
    (2) Information about discontinued studies described in 
Sec. 159.167.
    (3) Human epidemiological and exposure studies described in 
Sec. 159.170.
    (4) Detection of a pesticide in or on food or feed described in 
Sec. 159.178(a).
    (5) Detection of metabolites, degradates, contaminates, impurities 
described in Sec. 159.179.
    (6) Failure of performance studies described in Sec. 159.188(a)(2), 
(b)(2), and (c).
    (7) Other information described in Sec. 159.195.
    (b) Reportable information concerning detections of pesticides in 
water described in Sec. 159.178(b), adverse effects incidents described 
in Sec. 159.184(a), and efficacy failure incidents described in 
Sec. 159.188(a)(1) and (b)(1) must be reported according to the time 
frames set forth in Sec. 159.184(d).
    (c) EPA may, in its discretion, notify a registrant in writing of a 
different reporting period that will apply to specific types of 
reportable information or eliminate reporting requirements entirely. 
Such notification supersedes otherwise applicable reporting requirements 
set forth in this part.
    (d) For purposes of this part, a registrant possesses or knows of 
information at the time any officer, employee, agent, or other person 
acting for the registrant first comes into possession of, or knows of, 
such information; provided that, such person performs any activities for 
the registrant related to the development, testing, sale or registration 
of a pesticide or the person could be reasonably expected to come into 
possession of information otherwise reportable under this part. In the 
case of information known to or possessed by an agent or other person 
acting for the registrant, a registrant is responsible for such 
information only if the agent or other person acquired such information 
while acting for the registrant.

[63 FR 33582, June 19, 1998]

[[Page 127]]



Sec. 159.156   How information must be submitted.

    A submission under FIFRA section 6(a)(2) must be delivered as 
specified in either paragraph (a) or (b) of this section, and must meet 
the other requirements of this section:
    (a) Be mailed by certified or registered mail to the following 
address, or such other address as the Agency may subsequently specify in 
writing:

Document Processing Desk--6(a)(2), Office of Pesticide Programs--7504C, 
U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 
20460.

    (b) Be delivered in person or by courier service or by such other 
methods as the Agency deems appropriate to the following address, or to 
such other address as the Agency may subsequently specify in writing: 
Document Processing Desk--6(a)(2), Office of Pesticide Programs, Room 
266A, Crystal Mall 2, 1921 Jefferson Davis Highway, Arlington, Virginia 
22202.
    (c) Include a cover letter which contains the information requested 
in paragraphs (d) and (e) of this section, and a prominent statement 
that the information is being submitted in accordance with FIFRA section 
6(a)(2).
    (d) Contain the name of the submitter, registrant name and 
registration number, date of transmittal to EPA, the type of study or 
incident being reported under Secs. 159.165 through 159.195, and a 
statement of why the information is considered reportable under this 
part.
    (e) Identify the substance tested or otherwise covered by the 
information (including, if known, the EPA registration number(s) to 
which the information pertains, and if known, the CAS Registry Number).
    (f) In reporting incidents, provide the data listed in Sec. 159.184, 
to the extent such information is available.
    (g) In submitting scientific studies, follow the procedures set 
forth in Sec. 158.32 of this chapter.
    (h) If the information is part of a larger package being submitted 
in order to comply with another provision of FIFRA (e.g., sections 
3(c)(2)(B), 4(e)(1)(E)), identify in the transmittal the individual 
studies being submitted under this part.
    (i) If a claim of confidentiality is made under FIFRA section 10 for 
information relating to any part of a study or incident report contained 
in the submission, follow the procedures set forth in Sec. 158.33 of 
this chapter regarding the identification and segregation of information 
claimed to be confidential.
    (j) If a submission includes a study subject to the flagging 
requirements of Sec. 158.34 of this chapter, comply with the 
requirements of that section, and, if the flagging statement is 
positive, identify it as 6(a)(2) information in the transmittal.
    (k) If a submission is a follow-up to an earlier study or incident 
report submitted to EPA, the transmittal must state that fact, and must 
cite the earlier submission, as follows:
    (1) If the earlier submission was a study to which EPA assigned a 
Master Record Identifier number (MRID), cite the MRID.
    (2) If the previous submission was an incident report to which no 
MRID number was assigned, cite the date of the initial submission of the 
incident information or report.



Sec. 159.158   What information must be submitted.

    (a) General. Information which is reportable under this part must be 
submitted if the registrant possesses or receives the information, and 
the information is relevant to the assessment of the risks or benefits 
of one or more specific pesticide registrations currently or formerly 
held by the registrant. Information relevant to the assessment of the 
risks or benefits also includes conclusion(s) or opinion(s) rendered by 
a person who meets any of the following:
    (1) Who was employed or retained (directly or indirectly) by the 
registrant, and was likely to receive such information.
    (2) From whom the registrant requested the opinion(s) or 
conclusion(s) in question.
    (3) Who is a qualified expert as described in Sec. 159.153(b).
    (b)  Exceptions--(1) Clearly erroneous information. Information need 
not be submitted if before that date on which

[[Page 128]]

the registrant must submit such information if all of the following 
conditions are met:
    (i) The registrant discovers that any analysis, conclusion, or 
opinion was predicated on data that were erroneously generated, 
recorded, or transmitted, or on computational errors.
    (ii) Every author of each such analysis, conclusion, or opinion, or 
as many authors as can be contacted through the use of reasonable 
diligence, has acknowledged in writing that the analysis, conclusion, or 
opinion was improper and has either corrected the original analysis, 
conclusion, or opinion accordingly, or provided an explanation as to why 
it cannot be corrected.
    (iii) As a result of the correction, the information is no longer 
required to be reported under FIFRA section 6(a)(2), or if no correction 
was possible, the authors agree that the original analysis, conclusion 
or opinion has no scientific validity.
    (2) Previously submitted information. Information regarding an 
incident, study, or other occurrence need not be submitted if before the 
date on which the registrant must submit such information, the 
registrant is aware that the reportable information concerning that 
incident, study, or other occurrence is contained completely in one of 
the following:
    (i) Documents officially logged in by the EPA Office of Pesticide 
Programs.
    (ii) EPA publications, EPA hearing records, or publications cited in 
EPA Federal Register notices.
    (iii) Any other documents which are contained in the official files 
and records of the EPA Office of Pesticide Programs.
    (iv) Any documents officially logged in by the EPA Office of 
Pollution Prevention and Toxics under the provisions of section 8(e) of 
the Toxic Substances Control Act, provided that if the information 
pertains to a chemical compound which, subsequent to the submission of 
data under section 8(e), becomes the subject of an application for 
registration as a pesticide active ingredient, information is submitted 
to the Office of Pesticide Programs as required by 40 CFR 152.50(f)(3).
    (3) Publications. A published article or report containing 
information otherwise reportable under this part need not be submitted 
if it fits into either of the following categories:
    (i) Any scientific article or publication which has been abstracted 
in a recognized database of scientific and medical literature, such as 
Medline, ENBASE, Toxline or Index Medicus, if the abstract in question 
clearly identified the active ingredient or the registered pesticide(s) 
to which the information pertains. Otherwise reportable information 
received by or known to the registrant prior to publication of an 
abstract concerning the information must be reported and may not be 
withheld pending such publication.
    (ii) Reports or publications which have been made available to the 
public by any of the following Federal agencies: Centers for Disease 
Control and Prevention, Consumer Products Safety Commission, Department 
of Agriculture, Department of the Interior, Food and Drug Administration 
or any other agency or institute affiliated with the Department of 
Health and Human Services. Otherwise reportable information concerning 
research which was performed, sponsored, or funded by the registrant 
which may also appear in forthcoming Government reports or publications 
must be reported and may not be withheld pending publication.
    (4) Information concerning former inerts, contaminants or 
impurities. Notwithstanding any other provisions of this part, a 
registrant need not report information concerning a chemical compound 
that was at one time an inert ingredient or a contaminant or impurity of 
a pesticide product, and would otherwise be reportable under this part, 
if both of the following conditions are met:
    (i) The compound has been eliminated from its registered product due 
to changes in manufacturing processes, product formulation or by other 
means.
    (ii) The registrant has informed the appropriate product manager in 
the Office of Pesticide Programs in writing of the presence previously 
of the inert,

[[Page 129]]

contaminant or impurity in the product and its subsequent elimination 
from the product.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.159  Information obtained before promulgation of the rule.

    (a) Notwithstanding any other provision of this part, information 
held by registrants on August 17, 1998 which has not been previously 
submitted to the Agency, but which is reportable under the terms of this 
part, must be submitted to the Agency if it meets any of the following 
criteria:
    (1) Information is otherwise reportable under Sec. 159.184, and 
pertains to an incident that is alleged to have occurred on or after 
January 1, 1994, and to have involved any of the following:
    (i) A fatality or hospitalization of a human being.
    (ii) A fatality of a domestic animal.
    (iii) A fatality or fatalities to fish or wildlife, if the incident 
meets the criteria for the exposure type and severity category 
designation ``W-A'' set forth in Sec. 159.184(c)(5)(iii).
    (2) Submission of the information is requested by the Agency 
pursuant to Sec. 159.195(c).
    (b) If a registrant possesses information required to be submitted 
by paragraph (a)(1) of this section, the registrant must submit on or 
before June 16, 1999 in accordance with Sec. 159.156(c), (d), and (e) an 
inventory of the incidents that meet the requirements of paragraphs 
(a)(1) of this section. Such an inventory must include the separate 
number of incidents that meet the requirements of paragraphs (a)(1)(i), 
(a)(1)(ii), and (a)(1)(iii) of this section, and for each type of 
incident, the total numbers of fatalities or hospitalizations involved.
    (c) If a registrant possesses information required to be submitted 
by paragraph (a)(2) of this section, the information must be submitted 
in accordance with any schedule contained in the Agency's request for 
the information.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998, as amended at 
63 FR 41193, Aug. 3, 1998]



Sec. 159.160   Obligations of former registrants.

    (a) General. A former registrant is obliged to continue to submit 
information concerning the registration of a pesticide product 
previously held by the registrant and otherwise reportable under the 
provisions of this part for a period of 5 years after the registration 
of the pesticide product has been canceled or transferred to another 
registrant, with the exceptions provided by paragraph (b) of this 
section.
    (b) Exceptions. Notwithstanding the provisions of paragraph (a) of 
this section, a former registrant is not obligated to report information 
pursuant to this part if any of the following conditions are applicable:
    (1) The information is first obtained by the person more than 1 year 
after the date on which the person ceased to hold the registration of 
the product to which the information pertains, and the person holds no 
active pesticide registrations, or for some other reason cannot 
reasonably be expected to receive information concerning the formerly 
registered product.
    (2) The information is associated solely with an inert ingredient, 
contaminant, impurity, metabolite, or degradate contained in a product, 
and the information is first obtained by the person more than 1 year 
after the date upon which the person ceased to hold the registration of 
the product.
    (3) The information is associated with an active ingredient or a 
formerly registered product, and the active ingredient or every active 
ingredient contained in the formerly registered product has not been 
contained in any pesticide product registered in the United States for 
any part of the 3-year period preceding the date on which the person 
first obtained the information.
    (4) The information pertains solely to a formerly registered product 
that no longer meets the definition of ``pesticide'' in section 2(u) of 
FIFRA (7 U.S.C. section 136(u)).
    (c) Information arising from litigation. Notwithstanding any other 
provisions of this section, a former registrant is obliged to submit 
information otherwise reportable under this part concerning formerly-
registered pesticide

[[Page 130]]

products which arises in the course of litigation concerning the effects 
of such products, regardless of when the information is first acquired, 
provided that neither of the provisions of paragraphs (b)(3) or (b)(4) 
of this section are met. Such information shall be submitted in the same 
manner and according to the same schedules as it would have to be 
submitted by a current registrant of a pesticide product to which the 
information pertained.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.165  Toxicological and ecological studies.

    Adverse effects information must be submitted as follows:
    (a) Toxicological studies. (1) The results of a study of the 
toxicity of a pesticide to humans or other non-target domestic organisms 
if, relative to all previously submitted studies, they show an adverse 
effect under any of the following conditions:
    (i) That is in a different organ or tissue of the test organism.
    (ii) At a lower dosage, or after a shorter exposure period, or after 
a shorter latency period.
    (iii) At a higher incidence or frequency.
    (iv) In a different species, strain, sex, or generation of test 
organism.
    (v) By a different route of exposure.
    (2) Acute oral, acute dermal, acute inhalation or skin and eye 
irritation studies in which the only change in toxicity is a numerical 
decrease in the median lethal dose (LD50), median lethal 
concentration (LC50) or irritation indices, are not 
reportable under this part unless the results indicate a more 
restrictive toxicity category for labeling under the criteria of 40 CFR 
156.10(h).
    (b) Ecological studies. The results of a study of the toxicity of a 
pesticide to terrestrial or aquatic wildlife or plants if, relative to 
all previously submitted studies, they show an adverse effect under any 
of the following conditions:
    (1) At levels 50 percent or more lower than previous acute toxicity 
studies with similar species, including determinations of the median 
lethal dose (LD50), median lethal concentration 
(LC50), or median effective concentration (EC50).
    (2) At lower levels in a chronic study than previous studies with 
similar species.
    (3) In a study with a previously untested species the results 
indicate the chronic no observed effect level (NOEL) is 10 percent or 
less of the lowest LC50 or LD50 for a similar 
species.
    (4) For plants when tested at the maximum label application rate or 
less, if either of the following conditions is met:
    (i) More than 25 percent of terrestrial plants show adverse effects 
on plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (ii) More than 50 percent of aquatic plants show adverse effects on 
plant life cycle functions and growth such as germination, emergence, 
plant vigor, reproduction and yields.
    (c) Results from a study that demonstrates any toxic effect (even if 
corroborative of information already known to the Agency), must be 
submitted if the pesticide is or has been the subject of a Formal Review 
based on that effect within 5 years of the time the results are 
received. Within 30 calendar days of the publication of a Notice of 
Commencement of a Formal Review in the Federal Register, all information 
which has become reportable due to the commencement of the Formal Review 
must be submitted.
    (d) Incomplete studies. Information from an incomplete study of the 
toxicity to any organism of a registered pesticide product or any of its 
ingredients, impurities, metabolites, or degradation products which 
would otherwise be reportable under paragraphs (a), (b) or (c) of this 
section must be submitted if the information meets any one of the 
folowing three sets of criteria:
    (1) Short-term studies. A study using a test regimine lasting 90 
calendar days or less, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.

[[Page 131]]

    (iv) A reasonable period for completion of the final analysis not 
longer than 90 calendar days following completion of testing has 
elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (2) Long-term studies. A study using a test regimine lasting 90 
calendar days or less, and all of the following conditions are met:
    (i) All testing has been completed.
    (ii) A preliminary data analysis or gross pathological analysis has 
been conducted.
    (iii) Final analysis has not been completed.
    (iv) A reasonable period of completion of final analysis (not longer 
that 1 year following completion of testing) has elapsed.
    (v) Comparable information concerning the results of a completed 
study would be reportable.
    (3) Serious adverse effects. Any study in which testing or analysis 
of results is not yet complete but in which serious adverse effects have 
already been observed which may reasonably be attributed to exposure to 
the substances tested, because the effects observed in exposed organisms 
differ from effects observed in control organisms, are atypical in view 
of historical experience with the organism tested, or otherwise support 
a reasonable inference of causation, and 30 days have passed from the 
date the registrant first has the information.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.167   Discontinued studies.

    The fact that a study has been discontinued before the planned 
termination must be reported to EPA, with the reason for termination, if 
submission of information concerning the study is, or would have been, 
required under this part.



Sec. 159.170   Human epidemiological and exposure studies.

    Information must be submitted which concerns any study that a person 
described in Sec. 159.158(a) has concluded, or might reasonably 
conclude, shows that a correlation may exist between exposure to a 
pesticide and observed adverse effects in humans. Information must also 
be submitted which concerns exposure monitoring studies that indicate 
higher levels of risk or exposure than would be expected based on 
previously available reports, data, or exposure estimates. Such 
information must be submitted regardless of whether the registrant 
considers any observed correlation or association to be significant.



Sec. 159.178   Information on pesticides in or on food, feed or water.

    (a)  Food and feed. Information must be submitted if it shows that 
the pesticide is present in or on food or feed at a level in excess of 
established levels, except that information on excess residues resulting 
solely from studies conducted under authority of FIFRA section 5 or 
under other controlled research studies conducted to test a pesticide 
product need not be submitted, provided that the treated crop is not 
marketed as a food or feed commodity. The information to be submitted is 
the same as that required in Sec. 159.184(c)(1), (2), (3), and 
(4)(iv)(E), (F), (G), and (H).
    (b) Water. (1) Information must be submitted if it shows that a 
pesticide is present above the water reference level in any of the 
following instances:
    (i) Waters of the United States, as defined in Sec. 122.2 of this 
chapter, except paragraph (d) of Sec. 122.2.
    (ii) Ground water.
    (iii) Finished drinking water.
    (2) If the lowest detectable amount of the pesticide is reported, 
the detection limit must also be reported.
    (3) Information need not be submitted regarding the detection of a 
pesticide in waters of the United States or finished drinking water if 
the pesticide is registered for use in finished drinking water or 
surface water and the amount detected does not exceed the amounts 
reported by a registrant in its application for registration, as 
resulting in those waters from legal applications of the pesticide.
    (4) Information need not be submitted concerning detections of 
pesticides in waters of the United States, ground water or finished 
drinking water if the substance detected is an inert ingredient, or a 
metabolite, degradate, contaminant or impurity of

[[Page 132]]

a pesticide product, unless EPA has established or proposed a maximum 
contaminant level (MCL) or health advisory level (HAL) for that 
substance, or has estimated a health advisory level based on an 
established reference dose (RfD) for that substance, and notified 
registrants of that level.
    (5) Information to be submitted is the same as that required in 
Sec. 159.184(c)(1), (2), (3), (4)(iv) and (v), and (5)(vi).

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.179   Metabolites, degradates, contaminants, and impurities.

    (a) Metabolites and degradates. Information which shows the 
existence of any metabolite or degradate of a pesticide product must be 
submitted if either of the following conditions is met:
    (1) The metabolite or degradate may occur or be present under 
conditions of use of the pesticide product, and the existence of the 
metabolite or degradate or the association of the metabolite or 
degradate with the pesticide product has not been previously reported to 
EPA.
    (2) The metabolite or degradate has been previously reported, but it 
is detected at levels higher than any previously reported; and either of 
the following conditions is met:
    (i) Any person described in Sec. 159.158(a) has concluded that the 
metabolite or degradate may pose a toxicological or ecological risk 
based on any one or more of the following:
    (A) The physical or chemical properties of the metabolite or 
degradate.
    (B) Data regarding structurally analogous chemicals.
    (C) Data regarding chemical reactivity of the metabolite or 
degradate and structurally analogous substances.
    (D) Data on the metabolite or degradate.
    (ii) The registrant has concluded, or has been advised by any person 
described in Sec. 159.158(a) that the metabolite or degradate, or 
analogous chemicals, may have any experimentally determined half-life 
greater than 3 weeks as shown from laboratory aerobic soil metabolism 
studies or field dissipation studies, or may have any experimentally 
determined resistance to hydrolytic degradation, or photolytic 
degradation on soil or in water, under any conditions, resulting in 
degradation of less than 10 percent in a 30-day period.
    (b) Contaminants and impurities. The presence in any pesticide 
product of a contaminant or impurity not previously identified by the 
registrant as part of the pesticide product's approved composition must 
be reported pursuant to this part if the contaminant or impurity is 
present in the product in any of the following quantities:
    (1) Quantities greater than 0.1 percent by weight (1,000 parts per 
million).
    (2) Quantities that EPA considers, and so informs registrants, to be 
of toxicological significance.
    (3) Quantities that the registrant considers to be of toxicological 
significance.
    (4) Quantities above a level for which the registrant has 
information indicating that the presence of the contaminant or impurity 
may pose a risk to health or the environment.
    (5) Quantities that a person described in Sec. 159.158(a) has 
informed the registrant is likely to be of toxicological significance.

[62 FR 49388, Sept. 19, 1997; 63 FR 33582, June 19, 1998]



Sec. 159.184   Toxic or adverse effect incident reports.

    (a) General. Information about incidents affecting humans or other 
non-target organisms must be submitted if the following three conditions 
are met:
    (1) The registrant is aware, or has been informed that a person or 
non-target organism may have been exposed to a pesticide.
    (2) The registrant is aware, or has been informed that the person or 
non-target organism suffered a toxic or adverse effect, or may suffer a 
delayed or chronic adverse effect in the future.
    (3) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (b) Exceptions. Information regarding an incident need not be 
submitted if any of the following conditions are met:

[[Page 133]]

    (1) The registrant is aware of facts which clearly establish that 
the reported toxic effect, or reported exposure, did not or will not 
occur.
    (2) The registrant has been notified in writing by the Agency that 
the reporting requirement has been waived for this incident or category 
of incidents, and the registrant has not been notified in writing by the 
Agency that the waiver is rescinded.
    (3) It concerns a toxic effect to non-target plants, which were at 
the use site at the time the pesticide was applied, if the label 
provides adequate notice of such a risk.
    (4) It concerns non-lethal phytotoxicity to the treated crop if the 
label provides an adequate notice of such a risk.
    (5) It concerns a toxic effect to pests not specified on the label, 
provided that such pests are similar to pests specified on the label.
    (6) It concerns minor skin or eye irritation effects warned of on 
the label of a product which is registered for use in residential use 
sites, and the effects occurred as a result of use in a residential 
site.
    (c) Required information on individual incidents. To the extent that 
the registrant has any of the information listed in paragraphs (c)(1) 
through (c)(4) of this section, the registrant must supply the 
information on each pesticide incident that meets the requirements 
outlined in paragraph (a) of this section. If the registrant acquires 
additional information concerning an incident previously reported to the 
Agency under this part, such information shall be reported if it meets 
the criteria set forth in paragraph (f) of this section. In the future, 
the Agency may by notice specify a format for such submissions. The 
Administrative, Pesticide, Circumstance and Exposure Type(s) of 
information must be reported for individual incidents, except where the 
provisions of paragraph (e) of this section allow for aggregated summary 
forms of reporting, or if EPA in the future grants permission in writing 
for alternative reporting formats. The registrant must also provide one 
or more Exposure Type and Severity categories and their designations for 
each incident as set forth in paragraph (c)(5) of this section, 
depending on the applicability of the criteria listed below. The 
criteria listed should be used in assigning a category. For example, an 
incident which allegedly caused serious but non-fatal effects to human 
beings and domestic animals might be designated ``H-B: D-B.'' When a 
single incident involves multiple pesticides, the registrant need only 
report on their specific product. However, if a single incident involves 
more than one type of non-target organism--for example, both humans and 
domestic animals are involved--all appropriate available information 
dealing with each of the victims must also be reported. The 
informational items below are grouped by sections for ease in reporting 
pesticide incidents.
    (1) Administrative. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Name of reporter, address, and telephone number.
    (ii) Name, address, and telephone number of contact person (if 
different than reporter).
    (iii) Incident report status (e.g., new or update); if update, 
include the date of original submission.
    (iv) Date registrant became aware of the incident.
    (v) Date of incident (if appropriate, list start and end dates).
    (vi) Location of incident (city, county and state).
    (vii) Is incident part of a larger study.
    (viii) Source if different from reporting registrant.
    (2) Pesticide. Pesticide incident reports must be submitted for each 
pesticide that may have contributed to the incident, if the registrant 
possesses or receives any of the following information, and the incident 
meets the minimum requirements set forth in paragraph (a) of this 
section:
    (i) Product name.
    (ii) Active ingredient(s).
    (iii) EPA Registration Number.
    (iv) Diluted for use, or concentrate.
    (v) Formulation, if known.

[[Page 134]]

    (3) Circumstance. Pesticide incident reports must be submitted if 
the registrant possesses or receives any of the following information, 
and the incident meets the minimum requirements set forth in paragraph 
(a) of this section:
    (i) Evidence the label directions were not followed (e.g., yes, no, 
unknown).
    (ii) How exposed (e.g., spill, drift, equipment failure, container 
failure, mislabeling, runoff, etc.).
    (iii) Situation (e.g., household use, mixing/loading, application, 
reentry, disposal, transportation, other (describe)).
    (iv) Use site (e.g., home, yard, commercial turf, agricultural 
(specify crop), industrial, building/office, school, nursery, 
greenhouse, pond/lake/stream, well, forest/woods, other.
    (v) Applicator certified (yes, no, unknown).
    (vi) A brief description of the circumstances of the incident.
    (4) Other incident specific information. Pesticide incident reports 
must be submitted if the registrant possesses or receives any of the 
following information, and the incident meets the minimum requirements 
set forth in paragraph (a) of this section:
    (i) If the incident involves humans:
    (A) Route of exposure (skin, eye, respiratory, oral).
    (B) List signs/symptoms/adverse effects.
    (C) If laboratory tests were performed, list name of test(s) and 
results.
    (D) If available, submit laboratory report(s).
    (E) Time between exposure and onset of symptoms.
    (F) Was adverse effect the result of suicide/homicide or attempted 
suicide/homicide.
    (G) Type of medical care sought, (e.g., none, Poison Control Center, 
hospital emergency department, hospital inpatient, private physician, 
clinic, other).
    (H) Demographics (sex, age, occupation).
    (I) If female, pregnant?
    (J) Exposure data: amount of pesticide; duration of exposure; weight 
of victim.
    (K) Was exposure occupational; days lost due to illness.
    (L) Was protective clothing worn (specify).
    (ii) If domestic animal:
    (A) Type of animal (e.g., livestock, poultry, bird, fish, household 
pet e.g., dog/cat etc.).
    (B) List signs/symptoms/adverse effects.
    (C) Breed/species (name and number affected, per adverse effect).
    (D) Route of exposure (e.g., skin, eye, respiratory, oral).
    (E) Time between exposure and onset of symptoms.
    (F) If laboratory test(s) performed, list name of tests and results.
    (G) If available, submit laboratory report(s).
    (iii) If fish, wildlife, plants or other non-target organisms:
    (A) List species affected, and number of individuals per species.
    (B) List symptoms or adverse effects.
    (C) Magnitude of the effect (e.g., miles of streams, square area of 
terrestrial habitat).
    (D) Pesticide application rate, intended use site (e.g., corn, 
turf), and method of application.
    (E) Description of the habitat and the circumstances under which the 
incident occurred.
    (F) If plant, type of plant life (i.e., crop, forest, orchard, home 
garden, ornamental, forage).
    (G) Formulation of pesticide if not indicated by brand name 
(granular, flowable).
    (H) Distance from treatment site.
    (I) If laboratory test(s) performed, list name of test(s) and 
results.
    (J) If available, submit laboratory report(s).
    (iv) If surface water:
    (A) If raw water samples, water bodies sampled and approximate 
locations in each water body.
    (B) If raw water samples, proximity of sampling locations to 
drinking water supply intakes and identities of systems supplied.
    (C) If finished water samples, water supply systems sampled.
    (D) If finished water samples, percent surface water source by 
specific surface water sources to water supply system(s).
    (E) Sample type (grab, composite).
    (F) Sampling times/frequency.

[[Page 135]]

    (G) Pesticides and degredates analyzed for, the detection limits, 
and the amount detected.
    (H) Method of analysis.
    (v) If ground water:
    (A) Pesticides and degredates analyzed for, the analytical method 
used, the detection limits, and the amount detected.
    (B) Sample date.
    (C) Amount pesticide applied (lbs-ai/acre).
    (D) Date of last application.
    (E) Depth to water.
    (F) Latitude/longitude.
    (G) Soil series and texture (sand/silt/clay).
    (H) Frequency of applications per year.
    (I) Aquifer description (confined/unconfined).
    (J) Method of application.
    (K) Years pesticide used.
    (L) Well use and well identifier.
    (M) Screened interval.
    (N) Annual cumulative rainfall (inches).
    (O) Maximum rainfall and date.
    (P) Cumulative irrigation (inches).
    (Q) Hydrologic group.
    (R) Hydraulic conductivity.
    (S) pH.
    (T) Organic matter or organic carbon (percent).
    (vi) If property damage.
    (A) Provide description.
    (B) [Reserved]
    (5) Exposure types and severity category designations--(i) Humans. 
If an effect involves a human, provide the appropriate 2-letter exposure 
types and severity categories and their designations, based upon the 
following categories:
    (A) H-A: If the person died.
    (B) H-B: If the person alleged or exhibited symptoms which may have 
been life-threatening, or resulted in adverse reproductive effects or in 
residual disability.
    (C) H-C: If the person alleged or exhibited symptoms more 
pronounced, more prolonged or of a more systemic nature than minor 
symptoms. Usually some form of treatment of the person would have been 
Indicated. Symptoms were not life threatening and the person has 
returned to his/her pre-exposure state of health with no additional 
residual disability.
    (D) H-D: If the person alleged or exhibited some symptoms, but they 
were minimally traumatic. The symptoms resolved rapidly and usually 
involve skin, eye or respiratory irritation.
    (E) H-E: If symptoms are unknown, unspecified or are alleged to be 
of a delayed or chronic nature that may appear in the future.
    (ii) Domestic animals. If an effect involves a domestic animal, 
provide the appropriate 2-letter notation based upon the following 
categories:
    (A) D-A: If the domestic animal died or was euthanized.
    (B) D-B: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which may have been life-threatening or resulted in 
residual disability.
    (C) D-C: If the domestic animal exhibited or was alleged to have 
exhibited symptoms which are more pronounced, more prolonged or of a 
more systemic nature than minor symptoms. Usually some form of treatment 
would have been indicated to treat the animal. Symptoms were not life 
threatening and the animal has returned to its pre-exposure state of 
health with no additional residual disability.
    (D) D-D: If the domestic animal was alleged to have exhibited 
symptoms, but they were minimally bothersome. The symptoms resolved 
rapidly and usually involve skin, eye or respirator irritation.
    (E) D-E: If symptoms are unknown or not specified.
    (iii) Fish or wildlife. If an alleged effect involves fish or 
wildlife, label the incident W-A if any of the following criteria are 
met, or W-B if none of the criteria are met:
    (A) Involves any incident caused by a pesticide currently in Formal 
Review forecological concerns.
    (B) Fish: Affected 1,000 or more individuals of a schooling species 
or 50 or more individuals of a non-schooling species.
    (C) Birds: Affected 200 or more individuals of a flocking species, 
or 50 or moreindividuals of a songbird species, or 5 or more individuals 
of a predatory species.

[[Page 136]]

    (D) Mammals, reptiles, amphibians: Affected 50 or more individuals 
of a relatively common or herding species or 5 or more individuals of a 
rare or solitary species.
    (E) Involves effects to, or illegal pesticide treatment (misuse) of 
a substantial tract of habitat (greater than or equal to 10 acres, 
terrestrial or aquatic).
    (F) Involves a major spill or discharge (greater than or equal to 
5,000 gallons) of a pesticide.
    (G) Involves adverse effects caused by a pesticide, to federally 
listed endangered or threatened species.
    (iv) Plants. If an alleged effect involves damage to plants, label 
the incident P-A if the following criterion is met, or P-B if the 
criterion is not met:
    (A) The effect is alleged to have occurred on more than 45 percent 
of the acreage exposed to the pesticide.
    (B) [Reserved]
    (v) Other non-target organisms. If an alleged effect involves damage 
to non-target organisms other than fish, wildlife or plants (for 
example, beneficial insects), label the incident ONT.
    (vi) Water contamination. If a pesticide is alleged to have been 
detected in groundwater, surface water or finished drinking water, label 
the incident in accordance with the following criteria:
    (A) G-A: If the pesticide was detected at levels greater than the 
maximum contaminant level (MCL) or health advisory level (HAL) or an 
applicable criterion for ambient water quality.
    (B) G-B: If the pesticide was detected at levels greater than 10 
percent of the MCL, HAL or a criterion for ambient water quality but 
does not exceed the MCL or other applicable level.
    (C) G-C: If the pesticide was detected at levels less than 10 
percent of the MCL, HAL, or other applicable level, or there is no 
established level of concern.
    (vii) Property damage. If an incident involves alleged property 
damage the applicable term(s) shall be included along with any other 
applicable effect category label; for example, ``H-B: property damage.'' 
Label the incident in accordance with the following criteria:
    (A) PD-A: The product is alleged to have caused damage in a manner 
that could have caused direct human injury, such as fire or explosion.
    (B) PD-B: The product is alleged to have caused damage in excess of 
$5,000.
    (C) PD-C: Any allegation of property damage that does not meet the 
criteria of paragraphs (c)(5)(vii)(A) or (B) of this section, including 
cases in which the level of damages is not specified.
    (d) Time requirements for submitting incident information. 
Information concerning incidents reportable under this section must be 
submitted within the time frames listed for different exposure and 
severity categories, as follows:
    (1) For allegations involving human fatality (H-A), registrants must 
submit the required information, to the extent it is available, no later 
than 15 days after learning of an allegation.
    (2) Information concerning incidents which meet the criteria for the 
following exposure and severity category labels described in paragraph 
(c)(5) of this section, reports of detections of pesticides in water, 
and efficacy failure incidents may be described in Sec. 159.188(a)(1) 
and (b)(1), may be accumulated for a 30-day period, and submitted to the 
Agency within 30 days after the end of each 30-day accumulation period 
for: Humans, H-B, and H-C; Wildlife, W-A; Plants, P-A; Water, G-A; 
Property Damage, PD-A.
    (3) Incidents or reports of detections of pesticides in water 
meeting all other exposure and severity label categories, information 
may be accumulated by registrants for 90 days and submitted within 60 
days after the end of each 90-day accumulation period.
    (e) Aggregated reports. For incidents that are reportable under the 
schedule requirements of paragraph (d)(3) of this section, in lieu of 
individual reports containing the information listed in paragraphs 
(c)(1) through (c)(4) of this section, registrants must provide an 
aggregated report listing:
    (1) The time period covered by the report.
    (2) For each exposure and severity label category, a count of the 
number of incidents, listed by product registration number (if known) or 
active ingredient.
    (3) A count of domestic animal incidents in categories, other than 
D-A or

[[Page 137]]

D-B, which can be added together and reported as a single number.
    (f) Reporting additional information. If, after the submission of an 
incident report to the Agency, a registrant acquires additional 
information concerning that incident, the information should be 
submitted within the same time frame as applied to the original incident 
report, if any of the following conditions apply:
    (1) The information concerns an alleged human fatality (H-A), and 
the information consists of any of the elements listed in paragraphs 
(c)(1) through (c)(4) of this section.
    (2) The information concerns an incident originally reported as 
alleging a major human illness or injury (H-B), or fatality to a 
domestic animal (D-A), or wildlife (W-A), and the additional information 
consists of pesticide or circumstance information listed in paragraphs 
(c)(2) or (c)(3) of this section, or is a laboratory report concerning 
persons or animals involved in the incident.
    (3) The information concerns any incident not originally reported 
with one of the exposure and severity labels H-A, or H-B for human 
incidents, or at the ``A'' level of severity for any other exposure or 
incident type, and the new information would result in labeling the 
incident H-A or H-B for a human incident, or at the ``A'' level of 
severity for any other exposure or incident type listed in paragraph 
(c)(5) of this section.

[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]



Sec. 159.188   Failure of performance information.

    (a)  Microorganisms that pose a risk to human health. Information 
must be submitted which concerns either incidents described in paragraph 
(a)(1) of this section or a study described in paragraph (a)(2) of this 
section:
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed that a pesticide product may 
not have performed as claimed against target microorganisms.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against microorganisms which may pose a risk to human 
health.
    (iii) The pesticide product's use site is other than residential.
    (iv) The registrant has or could obtain information concerning where 
the incident occurred, the pesticide or product involved, and the name 
of a person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims made by the registrant regarding uses 
intended for control of microorganisms that may pose a risk to human 
health, including any of the public health antimicrobials identified in 
part 158 of this chapter.
    (b)  Animals that pose a risk to human health. For the purposes of 
this section, any animal (including insects) poses a risk to human 
health if it may cause disease in humans, either directly or as a 
disease vector; produce toxins that are harmful to humans; or cause 
direct physical harm to humans. Information must be submitted which 
concerns either incidents described in paragraph (b)(1) of this section 
or a study described in paragraph (b)(2) of this section.
    (1) Information which concerns an incident which meets all of the 
following conditions:
    (i) The registrant has been informed by municipal, State, or Federal 
public health officials that a pesticide product may not have performed 
as claimed against target animals.
    (ii) The possible failures of the pesticide to perform as claimed 
involved the use against animals that pose a risk to human health.
    (iii) The registrant has or could obtain information concerning 
where the incident occurred, the pesticide or product involved, and the 
name of a person to contact regarding the incident.
    (2) A study which indicates that the pesticide may not perform in 
accordance with one or more claims by the registrant regarding uses 
intended for control of animals that pose a risk to human health, 
including any of the public health pesticides identified in part 158 of 
this chapter.

[[Page 138]]

    (c) Development of pesticide resistance. Information must be 
submitted concerning substantiation of any incident of a pest having 
developed resistance to any pesticide (both public health and non-public 
health) that occurred under conditions of use, application rates and 
methods specified on the label if either of the following conditions is 
met:
    (1) The survival of the suspected pesticide-resistant pest was 
significantly higher than that of a known susceptible pest when both the 
suspected resistant and susceptible pests were treated with the 
pesticide under controlled conditions.
    (2) Biochemical tests or DNA sequencing indicate that the pest is 
resistant to the pesticide.



Sec. 159.195  Reporting of other information.

    (a) The registrant shall submit to the Administrator information 
other than that described in Secs. 159.165 through 159.188 if the 
registrant knows, or reasonably should know, that if the information 
should prove to be correct, EPA might regard the information alone or in 
conjunction with other information about the pesticide as raising 
concerns about the continued registration of a product or about the 
appropriate terms and conditions of registration of a product. Examples 
of the types of information which must be provided if not already 
reportable under some other provision of this Part include but are not 
limited to information showing:
    (1) Previously unknown or unexpected bioaccumulation of a pesticide 
by various life forms.
    (2) Greater than anticipated drift of pesticides to non-target 
areas.
    (3) Use of a pesticide may pose any greater risk than previously 
believed or reported to the Agency.
    (4) Use of a pesticide promotes or creates secondary pest 
infestations.
    (5) Any information which might tend to invalidate a study submitted 
to the Agency to support a pesticide registration.
    (b) A registrant is not obligated under paragraph (a) of this 
section to provide information to the Administrator if the registrant is 
aware of facts which establish that otherwise reportable information is 
not correct.
    (c) The registrant shall submit to the Administrator information 
other than that described in Secs. 159.165 through 159.188 if the 
registrant has been informed by EPA that such additional information has 
the potential to raise questions about the continued registration of a 
product or about the appropriate terms and conditions of registration of 
a product.

[62 FR 49388, Sept. 19, 1997; 63 FR 33583, June 19, 1998]



PART 160--GOOD LABORATORY PRACTICE STANDARDS--Table of Contents




                      Subpart A--General Provisions

Sec.
160.1  Scope.
160.3  Definitions.
160.10  Applicability to studies performed under grants and contracts.
160.12  Statement of compliance or non-compliance.
160.15  Inspection of a testing facility.
160.17  Effects of non-compliance.

                  Subpart B--Organization and Personnel

160.29  Personnel.
160.31  Testing facility management.
160.33  Study director.
160.35  Quality assurance unit.

                          Subpart C--Facilities

160.41  General.
160.43  Test system care facilities.
160.45  Test system supply facilities.
160.47  Facilities for handling test, control, and reference substances.
160.49  Laboratory operation areas.
160.51  Specimen and data storage facilities.

                          Subpart D--Equipment

160.61  Equipment design.
160.63  Maintenance and calibration of equipment.

                 Subpart E--Testing Facilities Operation

160.81  Standard operating procedures.
160.83  Reagents and solutions.
160.90  Animal and other test system care.

           Subpart F--Test, Control, and Reference Substances

160.105  Test, control, and reference substance characterization.

[[Page 139]]

160.107  Test, control, and reference substance handling.
160.113  Mixtures of substances with carriers.

             Subpart G--Protocol for and Conduct of a Study

160.120  Protocol.
160.130  Conduct of a study.
160.135  Physical and chemical characterization studies.

Subparts H-I [Reserved]

                     Subpart J--Records and Reports

160.185  Reporting of study results.
160.190  Storage and retrieval of records and data.
160.195  Retention of records.

    Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 
21 U.S.C. 346a, 348, 371, Reorganization Plan No. 3 of 1970.

    Source: 54 FR 34067, Aug. 17, 1989, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 160.1  Scope.

    (a) This part prescribes good laboratory practices for conducting 
studies that support or are intended to support applications for 
research or marketing permits for pesticide products regulated by the 
EPA. This part is intended to assure the quality and integrity of data 
submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (7 
U.S.C. 136a, 136c, 136f, 136q and 136v(c)) and sections 408 and 409 of 
the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 346a, 348).
    (b) This part applies to any study described by paragraph (a) of 
this section which any person conducts, initiates, or supports on or 
after October 16, 1989.



Sec. 160.3  Definitions.

    As used in this part the following terms shall have the meanings 
specified:
    Application for research or marketing permit includes:
    (1) An application for registration, amended registration, or 
reregistration of a pesticide product under FIFRA sections 3, 4 or 
24(c).
    (2) An application for an experimental use permit under FIFRA 
section 5.
    (3) An application for an exemption under FIFRA section 18.
    (4) A petition or other request for establishment or modification of 
a tolerance, for an exemption for the need for a tolerance, or for other 
clearance under FFDCA section 408.
    (5) A petition or other request for establishment or modification of 
a food additive regulation or other clearance by EPA under FFDCA section 
409.
    (6) A submission of data in response to a notice issued by EPA under 
FIFRA section 3(c)(2)(B).
    (7) Any other application, petition, or submission sent to EPA 
intended to persuade EPA to grant, modify, or leave unmodified a 
registration or other approval required as a condition of sale or 
distribution of a pesticide.
    Batch means a specific quantity or lot of a test, control, or 
reference substance that has been characterized according to 
Sec. 160.105(a).
    Carrier means any material, including but not limited to feed, 
water, soil, nutrient media, with which the test substance is combined 
for administration to a test system.
    Control substance means any chemical substance or mixture, or any 
other material other than a test substance, feed, or water, that is 
administered to the test system in the course of a study for the purpose 
of establishing a basis for comparison with the test substance for known 
chemical or biological measurements.
    EPA means the U.S. Environmental Protection Agency.
    Experimental start date means the first date the test substance is 
applied to the test system.
    Experimental termination date means the last date on which data are 
collected directly from the study.
    FDA means the U.S. Food and Drug Administration.
    FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 
U.S.C. 321 et seq).
    FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act 
as amended (7 U.S.C. 136 et seq).

[[Page 140]]

    Person includes an individual, partnership, corporation, 
association, scientific or academic establishment, government agency, or 
organizational unit thereof, and any other legal entity.
    Quality assurance unit means any person or organizational element, 
except the study director, designated by testing facility management to 
perform the duties relating to quality assurance of the studies.
    Raw data means any laboratory worksheets, records, memoranda, notes, 
or exact copies thereof, that are the result of original observations 
and activities of a study and are necessary for the reconstruction and 
evaluation of the report of that study. In the event that exact 
transcripts of raw data have been prepared (e.g., tapes which have been 
transcribed verbatim, dated, and verified accurate by signature), the 
exact copy or exact transcript may be substituted for the original 
source as raw data. ``Raw data'' may include photographs, microfilm or 
microfiche copies, computer printouts, magnetic media, including 
dictated observations, and recorded data from automated instruments.
    Reference substance means any chemical substance or mixture, or 
analytical standard, or material other than a test substance, feed, or 
water, that is administered to or used in analyzing the test system in 
the course of a study for the purposes of establishing a basis for 
comparison with the test substance for known chemical or biological 
measurements.
    Specimens means any material derived from a test system for 
examination or analysis.
    Sponsor means:
    (1) A person who initiates and supports, by provision of financial 
or other resources, a study;
    (2) A person who submits a study to the EPA in support of an 
application for a research or marketing permit; or
    (3) A testing facility, if it both initiates and actually conducts 
the study.
    Study means any experiment at one or more test sites, in which a 
test substance is studied in a test system under laboratory conditions 
or in the environment to determine or help predict its effects, 
metabolism, product performance (efficacy studies only as required by 40 
CFR 158.640), environmental and chemical fate, persistence and residue, 
or other characteristics in humans, other living organisms, or media. 
The term ``study'' does not include basic exploratory studies carried 
out to determine whether a test substance or a test method has any 
potential utility.
    Study completion date means the date the final report is signed by 
the study director.
    Study director means the individual responsible for the overall 
conduct of a study.
    Study initiation date means the date the protocol is signed by the 
study director.
    Test substance means a substance or mixture administered or added to 
a test system in a study, which substance or mixture:
    (1) Is the subject of an application for a research or marketing 
permit supported by the study, or is the contemplated subject of such an 
application; or
    (2) Is an ingredient, impurity, degradation product, metabolite, or 
radioactive isotope of a substance described by paragraph (1) of this 
definition, or some other substance related to a substance described by 
that paragraph, which is used in the study to assist in characterizing 
the toxicity, metabolism, or other characteristics of a substance 
described by that paragraph.
    Test system means any animal, plant, microorganism, chemical or 
physical matrix, including but not limited to soil or water, or subparts 
thereof, to which the test, control, or reference substance is 
administered or added for study. ``Test system'' also includes 
appropriate groups or components of the system not treated with the 
test, control, or reference substance.
    Testing facility means a person who actually conducts a study, i.e., 
actually uses the test substance in a test system. ``Testing facility'' 
encompasses only those operational units that are being or have been 
used to conduct studies.
    Vehicle means any agent which facilitates the mixture, dispersion, 
or solubilization of a test substance with a carrier.

[[Page 141]]



Sec. 160.10  Applicability to studies performed under grants and contracts.

    When a sponsor or other person utilizes the services of a consulting 
laboratory, contractor, or grantee to perform all or a part of a study 
to which this part applies, it shall notify the consulting laboratory, 
contractor, or grantee that the service is, or is part of, a study that 
must be conducted in compliance with the provisions of this part.



Sec. 160.12  Statement of compliance or non-compliance.

    Any person who submits to EPA an application for a research or 
marketing permit and who, in connection with the application, submits 
data from a study to which this part applies shall include in the 
application a true and correct statement, signed by the applicant, the 
sponsor, and the study director, of one of the following types:
    (a) A statement that the study was conducted in accordance with this 
part; or
    (b) A statement describing in detail all differences between the 
practices used in the study and those required by this part; or
    (c) A statement that the person was not a sponsor of the study, did 
not conduct the study, and does not know whether the study was conducted 
in accordance with this part.



Sec. 160.15  Inspection of a testing facility.

    (a) A testing facility shall permit an authorized employee or duly 
designated representative of EPA or FDA, at reasonable times and in a 
reasonable manner, to inspect the facility and to inspect (and in the 
case of records also to copy) all records and specimens required to be 
maintained regarding studies to which this part applies. The records 
inspection and copying requirements should not apply to quality 
assurance unit records of findings and problems, or to actions 
recommended and taken, except that EPA may seek production of these 
records in litigation or formal adjudicatory hearings.
    (b) EPA will not consider reliable for purposes of supporting an 
application for a research or marketing permit any data developed by a 
testing facility or sponsor that refuses to permit inspection in 
accordance with this part. The determination that a study will not be 
considered in support of an application for a research or marketing 
permit does not, however, relieve the applicant for such a permit of any 
obligation under any applicable statute or regulation to submit the 
results of the study to EPA.



Sec. 160.17  Effects of non-compliance.

    (a) EPA may refuse to consider reliable for purposes of supporting 
an application for a research or marketing permit any data from a study 
which was not conducted in accordance with this part.
    (b) Submission of a statement required by Sec. 160.12 which is false 
may form the basis for cancellation, suspension, or modification of the 
research or marketing permit, or denial or disapproval of an application 
for such a permit, under FIFRA section 3, 5, 6, 18, or 24 or FFDCA 
section 406 or 409, or for criminal prosecution under 18 U.S.C. 2 or 
1001 or FIFRA section 14, or for imposition of civil penalties under 
FIFRA section 14.



                  Subpart B--Organization and Personnel



Sec. 160.29  Personnel.

    (a) Each individual engaged in the conduct of or responsible for the 
supervision of a study shall have education, training, and experience, 
or combination thereof, to enable that individual to perform the 
assigned functions.
    (b) Each testing facility shall maintain a current summary of 
training and experience and job description for each individual engaged 
in or supervising the conduct of a study.
    (c) There shall be a sufficient number of personnel for the timely 
and proper conduct of the study according to the protocol.
    (d) Personnel shall take necessary personal sanitation and health 
precautions designed to avoid contamination of test, control, and 
reference substances and test systems.
    (e) Personnel engaged in a study shall wear clothing appropriate for 
the duties they perform. Such clothing shall be changed as often as 
necessary

[[Page 142]]

to prevent microbiological, radiological, or chemical contamination of 
test systems and test, control, and reference substances.
    (f) Any individual found at any time to have an illness that may 
adversely affect the quality and integrity of the study shall be 
excluded from direct contact with test systems, and test, control, and 
reference substances, and any other operation or function that may 
adversely affect the study until the condition is corrected. All 
personnel shall be instructed to report to their immediate supervisors 
any health or medical conditions that may reasonably be considered to 
have an adverse effect on a study.



Sec. 160.31  Testing facility management.

    For each study, testing facility management shall:
    (a) Designate a study director as described in Sec. 160.33 before 
the study is initiated.
    (b) Replace the study director promptly if it becomes necessary to 
do so during the conduct of a study.
    (c) Assure that there is a quality assurance unit as described in 
Sec. 160.35.
    (d) Assure that test, control, and reference substances or mixtures 
have been appropriately tested for identity, strength, purity, 
stability, and uniformity, as applicable.
    (e) Assure that personnel, resources, facilities, equipment, 
materials and methodologies are available as scheduled.
    (f) Assure that personnel clearly understand the functions they are 
to perform.
    (g) Assure that any deviations from these regulations reported by 
the quality assurance unit are communicated to the study director and 
corrective actions are taken and documented.



Sec. 160.33  Study director.

    For each study, a scientist or other professional of appropriate 
education, training, and experience, or combination thereof, shall be 
identified as the study director. The study director has overall 
responsibility for the technical conduct of the study, as well as for 
the interpretation, analysis, documentation, and reporting of results, 
and represents the single point of study control. The study director 
shall assure that:
    (a) The protocol, including any change, is approved as provided by 
Sec. 160.120 and is followed.
    (b) All experimental data, including observations of unanticipated 
responses of the test system are accurately recorded and verified.
    (c) Unforseen circumstances that may affect the quality and 
integrity of the study are noted when they occur, and corrective action 
is taken and documented.
    (d) Test systems are as specified in the protocol.
    (e) All applicable good laboratory practice regulations are 
followed.
    (f) All raw data, documentation, protocols, specimens, and final 
reports are transferred to the archives during or at the close of the 
study.



Sec. 160.35  Quality assurance unit.

    (a) A testing facility shall have a quality assurance unit which 
shall be responsible for monitoring each study to assure management that 
the facilities, equipment, personnel, methods, practices, records, and 
controls are in conformance with the regulations in this part. For any 
given study, the quality assurance unit shall be entirely separate from 
and independent of the personnel engaged in the direction and conduct of 
that study. The quality assurance unit shall conduct inspections and 
maintain records appropriate to the study.
    (b) The quality assurance unit shall:
    (1) Maintain a copy of a master schedule sheet of all studies 
conducted at the testing facility indexed by test substance, and 
containing the test system, nature of study, date study was initiated, 
current status of each study, identity of the sponsor, and name of the 
study director.
    (2) Maintain copies of all protocols pertaining to all studies for 
which the unit is responsible.
    (3) Inspect each study at intervals adequate to ensure the integrity 
of the study and maintain written and properly signed records of each 
periodic inspection showing the date of the inspection, the study 
inspected, the

[[Page 143]]

phase or segment of the study inspected, the person performing the 
inspection, findings and problems, action recommended and taken to 
resolve existing problems, and any scheduled date for reinspection. Any 
problems which are likely to affect study integrity found during the 
course of an inspection shall be brought to the attention of the study 
director and management immediately.
    (4) Periodically submit to management and the study director written 
status reports on each study, noting any problems and the corrective 
actions taken.
    (5) Determine that no deviations from approved protocols or standard 
operating procedures were made without proper authorization and 
documentation.
    (6) Review the final study report to assure that such report 
accurately describes the methods and standard operating procedures, and 
that the reported results accurately reflect the raw data of the study.
    (7) Prepare and sign a statement to be included with the final study 
report which shall specify the dates inspections were made and findings 
reported to management and to the study director.
    (c) The responsibilities and procedures applicable to the quality 
assurance unit, the records maintained by the quality assurance unit, 
and the method of indexing such records shall be in writing and shall be 
maintained. These items including inspection dates, the study inspected, 
the phase or segment of the study inspected, and the name of the 
individual performing the inspection shall be made available for 
inspection to authorized employees or duly designated representatives of 
EPA or FDA.
    (d) An authorized employee or a duly designated representative of 
EPA or FDA shall have access to the written procedures established for 
the inspection and may request testing facility management to certify 
that inspections are being implemented, performed, documented, and 
followed up in accordance with this paragraph.



                          Subpart C--Facilities



Sec. 160.41  General.

    Each testing facility shall be of suitable size and construction to 
facilitate the proper conduct of studies. Testing facilities which are 
not located within an indoor controlled environment shall be of suitable 
location to facilitate the proper conduct of studies. Testing facilities 
shall be designed so that there is a degree of separation that will 
prevent any function or activity from having an adverse effect on the 
study.



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.

[[Page 144]]

    (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 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

[[Page 145]]

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 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

[[Page 146]]

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.
    (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

[[Page 147]]

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 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

[[Page 148]]

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.
    (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.

[[Page 149]]

    (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 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

[[Page 150]]

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.
    (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 162--STATE REGISTRATION OF PESTICIDE PRODUCTS--Table of Contents




Subparts A-C [Reserved]

Subpart D--Regulations Pertaining to State Registration of Pesticides To 
                        Meet Special Local Needs

Sec.
162.150  General.
162.151  Definitions.
162.152  State registration authority.
162.153  State registration procedures.
162.154  Disapproval of State registrations.
162.155  Suspension of State registration authority.
162.156  General requirements.

Subpart E [Reserved]

Subparts A-C [Reserved]



Subpart D--Regulations Pertaining to State Registration of Pesticides To 
                        Meet Special Local Needs

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

[[Page 151]]


    Source: 46 FR 2014, Jan. 7, 1981, unless otherwise noted.



Sec. 162.150  General.

    (a) Scope. This subpart sets forth regulations governing the 
registration by any State of pesticide products, or uses thereof, 
formulated for distribution and use within the State to meet special 
local needs under sec. 24(c) of the Act. It also sets forth regulations 
governing the exercise by the Administrator of the power to disapprove 
specific State registrations and to suspend a State's registration 
authority under sec. 24(c). Unless otherwise indicated, any reference 
herein to registrations issued by a State includes amendments of 
registrations issued by States.
    (b) Applicability. This subpart applies only to State registration 
authority granted by sec. 24(c) of FIFRA. It does not apply to any 
authority granted, or procedures established, by State law with respect 
to registration, licensing, or approval required for use within the 
State of federally registered pesticide products.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 
32097, June 19, 1995]



Sec. 162.151  Definitions.

    Unless otherwise indicated, terms used in this subpart have the 
meanings set forth in FIFRA and in subpart A of this part. In addition, 
as used in this subpart, the following terms have the meanings set forth 
below:
    (a) Federally registered means currently registered under sec. 3 of 
the Act, after having been initially registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act of 1947 (Pub. L. 86-139; 73 
Stat. 286; June 25, 1947) by the Secretary of Agriculture or under FIFRA 
by the Administrator.
    (b) Manufacturing-use product means any pesticide product other than 
a product to be labeled with directions for end use. This term includes 
any product intended for use as a pesticide after re-formulation or 
repackaging.
    (c) New product means a pesticide product which is not a federally 
registered product.
    (d) Pest problem means (1) a pest infestation and its consequences, 
or (2) any condition for which the use of plant regulators, defoliants, 
or desiccants would be appropriate.
    (e) Product or pesticide product means a pesticide offered for 
distribution and use, and includes any labeled container and any 
supplemental labeling.
    (f) Similar composition refers to a pesticide product which contains 
only the same active ingredient(s), or combination of active 
ingredients, and which is in the same category of toxicity, as a 
federally registered pesticide product.
    (g) Similar product means a pesticide product which, when compared 
to a federally registered product, has a similar composition and a 
similar use pattern.
    (h) Similar use pattern refers to a use of a pesticide product 
which, when compared to a federally registered use of a product with a 
similar composition, does not require a change in precautionary labeling 
under Sec. 156.10(h) of this chapter, and which is substantially the 
same as the federally registered use. Registrations involving changed 
use patterns are not included in this term.
    (i) Special local need means an existing or imminent pest problem 
within a State for which the State lead agency, based upon satisfactory 
supporting information, has determined that an appropriate federally 
registered pesticide product is not sufficiently available.
    (j) State or State lead agency as used in this subpart means the 
State agency designated by the State to be responsible for registering 
pesticides to meet special local needs under sec. 24(c) of the Act.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988]



Sec. 162.152  State registration authority.

    (a) Statutory limitations. In accordance with sec. 24(c) of the Act, 
each State is authorized to register a new end use product for any use, 
or an additional use of a federally registered pesticide product, if the 
following conditions exist:
    (1) There is a special local need for the use within the State;
    (2) The use is covered by necessary tolerances, exemptions or other 
clearances under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 346 
et seq.), if the use is a food or feed use;

[[Page 152]]

    (3) Registration for the same use has not previously been denied, 
disapproved, suspended or cancelled by the Administrator, or voluntarily 
cancelled by the registrant subsequent to issuance by the Administrator 
of a notice of intent to cancel that registration, because of health or 
environmental concerns about an ingredient contained in the pesticide 
product, unless such denial, disapproval, suspension or cancellation has 
been superseded by subsequent action of the Administrator; and
    (4) The registration is in accord with the purposes of FIFRA.
    (b) Types of registrations--(1) Amendments to federal registrations. 
(i) Subject to the provisions of paragraphs (a) and (b)(1)(ii)(iv) of 
this section, States may register any new use of a federally registered 
pesticide product.
    (ii) A State may register any use of a federally registered product 
for which registration of other uses of the product was denied, 
disapproved, suspended, or cancelled by the Administrator, provided that 
the State may register a use not considered by the Administrator in 
reaching such a determination only after the State consults with 
appropriate EPA personnel.
    (iii) Except as provided in paragraph (a)(3) of this section, a 
State may register any use of a federally registered product for which 
registration of some or all uses has been voluntarily cancelled by the 
registrant, provided that a State may register such a use only after the 
State has consulted with appropriate EPA personnel.
    (iv) A State may not register an amendment to a federally registered 
manufacturing-use product.
    (2) New products. (i) Subject to the provisions of paragraph (a) and 
subparagraphs (b)(2) (ii) and (iii) of this section, a State may issue 
registrations to meet special local needs for the following types of new 
end-use products:
    (A) A product which is identical in composition to a federally 
registered product, but which has differences in packaging, or in the 
identity of the formulator.
    (B) A product which contains the same active and inert ingredients 
as a federally registered product, but in different percentages.
    (C) Subject to the requirements of paragraph (b)(2)(ii) of this 
section, a product containing a new combination of active, or active and 
inert, ingredients.
    (ii) A State may register a new product only if each of the active 
ingredients in the new product is present because of the use of one or 
more federally registered products and if each of the inert ingredients 
in the new product is contained in a federally registered product.
    (iii) A State may not register a new manufacturing-use product.
    (iv) A State may register any use of a new product containing an 
ingredient described in paragraph (a)(3) of this section, if the new 
product registration is for a formulation or a use not included in the 
denial, disapproval, suspension, or cancellation, or if the federally 
registered use was voluntarily cancelled without a prior notice of 
intent to cancel by the Administrator. However, a formulation or use of 
such a new product which was not considered by the Administrator during 
such proceedings, or which was not the subject of a notice of intent to 
cancel, may be registered by a State only after the State consults with 
appropriate EPA personnel regarding the registration application.
    (c) Effect of State registration. (1) A State registration issued 
under FIFRA sec. 24(c) which meets the conditions described in 
paragraphs (a) and (b) of this section, and which is not disapproved by 
the Administrator under Sec. 162.154, shall be considered a federal 
registration, but shall authorize distribution and use only within that 
State. Accordingly, such registrations are subject to all provisions of 
FIFRA which apply to currently registered products, including provisions 
for cancellation and suspension of registrations, and reregistration of 
products.
    (2) A State may require, as a condition of distribution or use of a 
pesticide product within the State, that the pesticide product be 
registered under State law as well as under FIFRA. Neither FIFRA sec. 
24(c) nor Secs. 162.150-162.156 affects a State's right under its own 
law to revoke, suspend,

[[Page 153]]

cancel, or otherwise affect such a registration issued under State law. 
However, the federal registration, whether issued under FIFRA sec. 3 or 
24(c), is not affected by such a State action.



Sec. 162.153  State registration procedures.

    (a) Application for registration. States shall require all 
applicants for registration to submit the following information:
    (1) Name and address of the applicant and any other person whose 
name will appear on the labeling or in the directions for use.
    (2) The name of the pesticide product, and, if the application is 
for an amendment to a federally registered product, the EPA registration 
number of that product.
    (3) A copy of proposed labeling, including all claims made for the 
product as well as directions for its use to meet the special local 
need, consisting of:
    (i) For a new product, a copy of the complete proposed labeling; or,
    (ii) For an additional use of a federally registered product, a copy 
of proposed supplemental labeling and a copy of the labeling for the 
federally registered product.
    (4) The complete formula of the product, if the application is for a 
new product registration.
    (5) Any other information which is required to be reviewed prior to 
registration under this section.
    (b) Special local need determination. In reviewing any application 
for registration, the State shall determine whether there is a special 
local need for the registration. Situations which a State may consider 
as not involving a special local need may include, but are not limited 
to, applications for registrations to control a pest problem present on 
a nationwide basis, or for use of a pesticide product registered by 
other States on an interregional or nationwide basis.
    (c) Unreasonable adverse effects determination. (1) Prior to issuing 
a registration in the following cases, the State shall determine that 
use of the product for which registration is sought will not cause 
unreasonable adverse effects on man or the environment, when used in 
accordance with labeling directions or widespread and commonly 
recognized practices:
    (i) For use of a product which has a composition not similar to any 
federally registered product.
    (ii) For use of a project involving a use pattern not similar to any 
federally registered use of the same product or of a product with a 
similar composition.
    (iii) For use of a product for which other uses of the same product, 
or of a product with a similar composition, have had registration 
denied, disapproved, suspended, or cancelled by the Administrator.
    (2) Determinations required by paragraph (c)(1) of this section 
shall be based on data and criteria consistent with those sections of 
part 152 of this chapter, applicable to the type of product or use under 
consideration. Such determinations may also involve consideration of the 
effect of the anticipated classification of the product or use under 
Sec. 162.153(h).
    (d) Efficacy determination. Prior to registration of any use of a 
product for public health purposes--that is, a use which could result in 
substantial harm to the public health if the product does not perform 
its intended function, the State shall determine that the product 
warrants the claims made for it in the registration application. Such 
determinations shall be based on criteria specified in applicable 
sections of part 152 of this chapter and on any additional criteria 
established by the State.
    (e) Labeling requirements. (1) Prior to issuing any registration, 
the State shall review the proposed labeling submitted with the 
application to determine compliance with this paragraph. In addition, 
the State shall review a copy of the final printed labeling as soon as 
practical after a registration is issued in order to verify compliance 
with this paragraph.
    (2) For a new product, the State must, as a condition of the 
registration, require that the product be accompanied from the time it 
enters the stream of commerce by labeling meeting all applicable 
criteria of Sec. 156.10 of this chapter. New product labeling must all 
contain:

[[Page 154]]

    (i) A statement identifying the State where registration is to be 
valid.
    (ii) The special local need registration number assigned by the 
State.
    (3) Except as provided in paragraph (e)(4) of this section, as a 
condition for a registration of an additional use of a federally 
registered product, the State must require that at the time of sale to 
users, labeling from the federally registered product be accompanied by 
supplemental labeling which contains:
    (i) A statement identifying the State where registration is valid.
    (ii) Directions for use to meet the special local need which satisfy 
the criteria of Sec. 156.10(i) of this chapter.
    (iii) The trade name of the product.
    (iv) The name and address of the section 24(c) registrant.
    (v) The EPA registration number of the federally registered product.
    (vi) The special local need registration number assigned by the 
State.
    (vii) A statement prohibiting use of the product in a manner 
inconsistent with all applicable directions, restrictions, and 
precautions found in the labeling of the federally registered product 
and accompanying supplemental labeling.
    (4) When a federally registered product is already in the stream of 
commerce at the time the State issues a registration for an additional 
use of that product, the State must ensure that supplemental labeling 
for the additional use, meeting the criteria of paragraph (e)(3) of this 
section, is made available to purchasers and users of the product within 
45 days of the date on which the State approves the final printed 
supplemental labeling.
    (5) If a State classifies for restricted use a product or use 
registered by the State, which is not required to be so classified by 
paragraph (g) of this section, then the State may require supplemental 
labeling for the product or use containing additional appropriate 
precautions, and a statement that the product or use is for restricted 
use within that State.
    (f) Packaging and coloration standards. All products registered by a 
State must meet all appropriate packaging standards prescribed by the 
Administrator under sec. 25(c)(3) of FIFRA. State registered products 
must also meet all appropriate standards for coloration, or 
discoloration, established by regulation under sec. 25(c) of FIFRA, 
including the standards contained in subpart H of part 153 of this 
chapter. Prior to issuing any registration, the State shall determine 
that the product will conform to these requirements.
    (g) Classification. (1) As part of the registration of any product 
or use, a State shall classify the product or use as a restricted use 
pesticide if:
    (i) The product is identical or similar in composition to a 
federally registered product:
    (A) For which all federally registered uses have been classified as 
restricted by the Administrator; or
    (B) For which a use similar to the State registered use has been 
classified as restricted by the Administrator; or
    (ii) The State registered product or use meets the criteria for 
classification as a restricted use pesticide under the applicable 
provisions of Sec. 152.170 of this chapter.
    (2) [Reserved]
    (h) Notification and Submission of Data. (1) Within ten working days 
from the date a State issues, amends, or revokes a registration, the 
State shall notify EPA, in writing, of the action. Notification of State 
registrations, or amendments thereto, shall include the effective date 
of the registration or amendment, a confidential statement of the 
formula of any new product, and a copy of the draft labeling reviewed 
and approved by the State, provided that labeling previously approved by 
the Administrator as part of a federal registration need not be 
submitted.
    (2) Notification of State registrations or amendments shall be 
supplemented by the State sending to EPA a copy of the final printed 
labeling approved by the State within 60 days after the effective date 
of the registration or amendment.
    (3) Notification of revocation of a registration by a State shall 
indicate the effective date of revocation, and shall state the reasons 
for revocation.
    (4) The Administrator or his designee may request, when appropriate, 
that a State submit to EPA any data used by the State to determine that 
unreasonable adverse effects will not be caused

[[Page 155]]

when the State registers any use described in paragraph (c)(1) of this 
section. Within 15 working days of receipt of such a request from EPA, 
the State shall submit two copies of the requested data.
    (i) Federal Register Publication. The Administrator shall publish in 
the Federal Register, on a regular basis, a summary of all State 
registrations made under sec. 24(c) during a previous reporting period 
established by the Administrator. For each product or use registered, 
the notice shall indicate:
    (1) The name of the product.
    (2) The name of the registrant.
    (3) The registered use(s) of the product.
    (4) The effective date of the State registration.
    (5) If the registration is for an additional use of a federally 
registered product, whether the State registration involves a changed 
use pattern.

[46 FR 2014, Jan. 7, 1981, as amended at 53 FR 15999, May 4, 1988; 60 FR 
32097, June 19, 1995]



Sec. 162.154  Disapproval of State registrations.

    (a) General disapprovals. (1) Except as provided in paragraph (b) of 
this section, the Administrator may disapprove, on any reasonable 
grounds, any state registration which, when compared to a federally 
registered product, does not have both a similar composition and a 
similar use pattern; provided that the Administrator may not disapprove 
such a registration solely because of a lack of essentiality. Grounds 
for disapproval of State registrations not involving similar products 
may include, but are not limited to:
    (i) Probable creation of unreasonable adverse effects on man or the 
environment by the registered use.
    (ii) Refusal of the registering State to submit information 
supporting the registration as required by Sec. 162.153(h).
    (iii) Failure of information submitted by the State to support the 
State's decision to issue the registration under standards established 
by Sec. 162.153.
    (2) Prior to disapproval of any State registration under this 
paragraph, the Administrator shall notify the registering State, in 
writing, of the Administrator's intent to disapprove, and of the reasons 
for disapproval. The notice of intent will provide a reasonable time, 
not less than ten days from the date the notice is received by the 
State, for the State to respond, and will invite the State to consult 
with the Administrator or his designee. If the grounds for disapproval 
are based on actions or omissions by the State, the notice will, if 
possible, also provide the State with a reasonable amount of time in 
which to take corrective action, not to exceed the time allowed for 
disapproval under paragraph (c) of this section.
    (3) The registering State may, within ten days of receipt of a 
notice of intent to disapprove, request that the Administrator, or his 
designee, consult with appropriate State officials prior to the 
Administrator's final decision on disapproval. The Administrator will 
consider any relevant information presented at such a consultation, or 
in any other timely and appropriate fashion, in deciding whether to 
withdraw the notice of intent to disapprove.
    (b) Special disapprovals. (1) The Administrator may disapprove any 
State registration, including a registration for a similar product, at 
any time, if the Administrator determines that use of the product under 
the State registration:
    (i) Would constitute an imminent hazard.
    (ii) May result in a residue on food or feed exceeding, or not 
covered by, a tolerance, exemption, or other clearance under the Federal 
Food, Drug and Cosmetic Act (21 U.S.C. 346a et seq.).
    (2) If the Administrator disapproves a registration under this 
paragraph, the Administrator shall provide the registering State with 
written notification of disapproval, in accordance with paragraph (c) of 
this section, as soon thereafter as practicable. Such notification will 
specify the grounds for disapproval and invite the State to comment on 
the decision.
    (3) If requested by the State within ten days of its receipt of a 
notice of disapproval, the Administrator, or his designee, will consult 
with appropriate State officials. The Administrator may consider any 
information presented at such a consultation, or in any other 
appropriate fashion, in determining

[[Page 156]]

whether the disapproval should be rescinded.
    (c) Decision and notification of disapproval. Except as provided in 
paragraph (b)(1) of this section, the Administrator will make a final 
decision on disapproval of a State registration, and provide written 
notification thereof to the State, within 90 days of the effective date 
of the registration; provided that, if the State does not notify the 
Agency of a registration within ten days of its effective date, then the 
Administrator will make a final decision on disapproval within 90 days 
of the date on which EPA receives notification of the State 
registration. The notice of disapproval will specify an appropriate date 
on which the disapproval will become effective. Disapproval may become 
effective immediately, or at anytime within the period allowed for the 
Administrator to make a final decision on disapproval. The notice of 
disapproval will also, when appropriate, give instructions for use or 
disposal of the pesticide. Each notice of disapproval will be published 
in the Federal Register.
    (d) Effect of disapproval. If a registration issued by a State is 
disapproved by the Administrator, that registration will not be valid 
for any purpose under FIFRA, as of the date the disapproval becomes 
effective. Thereafter, distribution or sale of the pesticide, in either 
interstate or intrastate commerce, for uses subject to the disapproval 
will be a violation of sec. 12(a)(1) of FIFRA.
    (e) Rescission of disapproval. If the Administrator determines, 
after consultation with the State lead agency, that a registration, 
previously issued by the State and disapproved by the Administrator, 
should not have been disapproved under FIFRA, then the Administrator 
shall rescind the disapproval. The Administrator shall send written 
notification of the rescission to the State. In addition, the 
Administrator shall publish notice of any rescission of disapproval in 
the Federal Register.
    (f) Notification of registrants. Any State that issues a 
registration which has been disapproved, or which is subject to a notice 
of intent to disapprove, shall be responsible for notifying the affected 
registrant of any such notice of intent or disapproval, and of any 
recession of disapproval by the Administrator.



Sec. 162.155  Suspension of State registration authority.

    (a) General. (1) If the Administrator finds that a State is not 
capable of exercising, or has failed to exercise, adequate control over 
its registration program, so that the State cannot ensure that 
registrations issued by it will be in accord with the purposes of FIFRA, 
then the Administrator may suspend the State's authority to register 
pesticides under sec. 24(c) of the Act. Registrations issued by the 
State after suspension of its authority will not be considered valid 
under FIFRA. Registrations issued by the State prior to suspension will 
not be affected by the suspension.
    (2) The Administrator may suspend all or any part of a State's 
registration authority, as appropriate.
    (b) Grounds for Suspension. (1) The Administrator may suspend a 
State's registration authority due to lack of, or failure to exercise, 
adequate control by the State over its sec. 24(c) registration program. 
Adequate control includes, but is not limited to, all of the following:
    (i) Access to appropriate scientific and technical personnel to 
review data and make determinations as required by Sec. 162.153.
    (ii) Registration procedures satisfying Sec. 162.153.
    (iii) Complete and accurate records of State registrations.
    (iv) Adequate legal authority. (A) To deny, suspend, revoke, or 
amend a State registration when the registration is not in compliance 
with FIFRA, this subpart, or State law, or when necessary to prevent 
unreasonable adverse effects on the environment.
    (B) To enter, at reasonable times, by consent, warrant, or other 
legal means, any establishment where pesticides are produced or held for 
distribution or sale, to inspect, sample, and observe whether pesticides 
are being produced or distributed in compliance with FIFRA, this 
subpart, State law, and the terms of any State registration.
    (2) The Administrator may suspend a State's registration authority 
if the

[[Page 157]]

State fails to exercise the controls specified in paragraph (b)(1) of 
this section, or if the State refuses to correct within a reasonable 
time any other significant deficiencies in its regulatory program, as 
specified by the Administrator in a notice of intent to suspend.
    (c) Procedures for Suspension. (1) Prior to suspending the 
registration authority of any State, the Administrator will notify the 
State lead agency, in writing, of the Administrator's intent to suspend, 
and of the specific grounds for suspension. The notice of intent will 
specify whether the suspension will be complete or partial, and will 
provide the State an opportunity to respond and a reasonable amount of 
time, not less than 30 days from the date the notice is received, in 
which to correct the deficiencies specified in the notice. If the State 
does not correct the specified deficiencies within the reasonable time 
allowed by the notice, or if the Administrator has not withdrawn the 
notice of intent before that time, the notice of intent will be 
published in the Federal Register, and the public given an opportunity 
to comment thereon.
    (2) If requested by the affected State lead agency within 30 days of 
receipt of the notice of intent to suspend, an informal consultation 
between appropriate State and EPA officials will be held to discuss the 
proposed suspension. In such a case, the Administrator shall not make a 
final decision on the proposed suspension until after the consultation. 
The Administrator shall consider all relevant information presented at 
the consultation, or in any other appropriate manner, in determining 
whether to suspend the State's authority. If the Administrator 
determines, on the basis of such information, that the deficiencies 
listed in the notice of intent no longer exist, or will be corrected in 
a reasonable time, then the Administrator will withdraw, in writing, the 
notice of intent to suspend.
    (3) Within ten days of the date a notice of intent to suspend is 
published in the Federal Register, a State may request a public hearing 
to consider the proposed suspension. If a hearing is requested, the 
Administrator will:
    (i) Schedule a public hearing to be held in that State.
    (ii) Publish in the Federal Register a notice announcing the date, 
time, and location of the hearing.
    (iii) Appoint a presiding officer who shall preside over the 
hearing.
    (iv) Prescribe additional, appropriate procedures for the conduct of 
the hearing, including procedures for the presentation of relevant 
material evidence from the State, EPA, or members of the public who 
would be affected by the outcome of the hearing. Evidence may be 
presented in either oral or written form, at the discretion of the 
Administrator.
    (4) Following the close of any hearing held under paragraph (c)(3) 
of this section, the presiding officer shall make a recommended decision 
that the State's authority to register pesticides under sec. 24(c) of 
FIFRA be suspended, in whole or in part, or that the State's authority 
not be suspended and that the notice of intent to suspend be withdrawn.
    (5) Any recommended decision made by a presiding officer under 
paragraph (c)(4) of this section may be appealed to the Administrator 
within 30 days after its issuance by the State or by EPA. Any 
recommended decision which is not appealed, or which the Administrator 
does not review on his own initiative, will become a final Agency action 
30 days after its issuance.
    (6) If no hearing is requested under paragraph (c)(3) of this 
section, or if a recommended decision is appealed to the Administrator 
under paragraph (c)(5) of this section, the Administrator shall issue a 
final order either suspending the State's authority to register 
pesticides under section 24(c) of FIFRA, in whole or in part, or 
withdrawing the notice of intent to suspend.
    (7) Any final order suspending State registration authority, issued 
under paragraph (c) (5) or (6) of this section, will specify the grounds 
therefor and an effective date for the suspension. If the suspension is 
merely partial, the notice of suspension will specify the types of 
registrations which will not be recognized as valid under sec. 24(c). 
All final orders issued under paragraph (c)

[[Page 158]]

(5) or (6) will be published in the Federal Register.
    (d) Termination of suspension. Suspension of a State's authority 
will be effective for the period specified in the notice of suspension, 
or if no period was specified, until such time as the Administrator is 
satisfied that the State can and will exercise adequate control over its 
program. In the latter case, the Administrator will notify the State 
that the suspension is terminated, or that it will be terminated on a 
specific date. In either case, the Administrator will publish a notice 
of the termination of suspension in the Federal Register.
    (e) Judicial review. Any State whose authority to register 
pesticides has been finally suspended by the Administrator may seek 
judicial review of the Administrator's decision under sec. 16 of FIFRA, 
at any time prior to termination of the suspension. Such suspension 
shall remain in effect during the period of judicial review unless 
otherwise ordered by the Administrator.



Sec. 162.156  General requirements.

    (a) Requirements for distribution and use. (1) Any product whose 
State registration has been issued in accordance with Secs. 162.152 and 
162.153 may be distributed and used in that State, subject to the 
following provisions of the Act and the regulations promulgated 
thereunder:
    (i) Sec. 12(a)(1) (A) through (E), in accordance with:
    (A) Sec. 2(q)(1) (A) through (G).
    (B) Sec. 2(q)(2) (A) through (D).
    (ii) Sec. 12(a)(2) (A) through (G) and (I) through (P).
    (2) A product or use classified by a State for restricted use under 
Sec. 162.153(g) may be used only by, or under the direct supervision of, 
an applicator certified under a plan approved by EPA in accordance with 
sec. 4 of FIFRA.
    (3) State registrations which are not issued in accordance with 
Sec. 162.152 (a) and (b)(2) (i), (ii) and (iii) are not authorized by 
section 24(c) and are not considered valid for any purposes under FIFRA. 
When the Administrator determines that a registration is invalid, the 
Administrator shall notify the registering State that the registration 
is invalid, and may specify the reason for the invalidity.
    (b) Establishment registration requirements. No person may produce 
any pesticide, including any pesticide registered by a State under 
section 24(c), unless the establishment in which it is produced is 
registered by the Administrator in accordance with sec. 7 of FIFRA and 
40 CFR part 167.
    (c) Books and records requirements. All producers of pesticides, 
including those producers of pesticides registered by States under sec. 
24(c), must maintain records in accordance with the requirements imposed 
under sec. 8 of FIFRA and 40 CFR part 169.

Subpart E [Reserved]



PART 163--CERTIFICATION OF USEFULNESS OF PESTICIDE CHEMICALS--Table of Contents




Sec.
163.1  Words in the singular form.
163.2  Definitions.
163.3  Administration.
163.4  Filing of requests for certification.
163.5  Material in support of the request for certification.
163.6  Certification limited to economic poison uses.
163.7  Factors considered in determining usefulness.
163.8  Basis for determination of usefulness.
163.9  Proposed certification; notice; request for hearing.
163.10  Withdrawal of request for certification pending clarification or 
          completion.
163.11  Registration under the Federal Insecticide, Fungicide, and 
          Rodenticide Act.
163.12  Opinion as to residue.

    Authority: 21 U.S.C. 346a.

    Source: 36 FR 22533, Nov. 25, 1971, unless otherwise noted.



Sec. 163.1  Words in the singular form.

    Words in this part in the singular form shall be deemed to import 
the plural, and vice versa, as the case may demand.



Sec. 163.2  Definitions.

    Unless the context otherwise requires, the following terms shall be 
construed, respectively, to mean:
    (a) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
301

[[Page 159]]

et seq.), as amended by Pub. L. 518, 83d Congress, 2d Session, ``An Act 
to amend the Federal Food, Drug, and Cosmetic Act with respect to 
residues of pesticide chemicals in or on raw agricultural commodities'' 
(68 Stat. 511).
    (b) Director means the Director of the Pesticides Regulation 
Division, Environmental Protection Agency, Washington, D.C.
    (c) Agency means the Environmental Protection Agency.
    (d) Pesticide chemical and raw agricultural commodity shall have the 
same meanings as they have in paragraphs (q) and (r), respectively, of 
section 201 of the Act.
    (e) Economic poison shall have the same meaning as it has under the 
Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135-135k) 
and the regulations issued thereunder.
    (f) Person means individuals, partnerships, corporations, and 
associations.
    (g) Certification means a certification by the Director that a 
pesticide chemical is useful for the purpose for which a tolerance or 
exemption is sought under the act.
    (h) Petition means a petition filed with the Administrator, 
Environmental Protection Agency pursuant to section 408(d)(1) of the 
Act.

[36 FR 22533, Nov. 25, 1971, as amended at 53 FR 15999, May 4, 1988]



Sec. 163.3  Administration.

    The Director is authorized to take such action as, in his 
discretion, may be necessary to carry out the provisions of sections 
408(i) and 408(l) of the Act and the regulations in this part.



Sec. 163.4  Filing of requests for certification.

    All requests for a certification shall be made in writing to the 
Director. Action upon such a request will not be undertaken unless (a) 
the person making the request has, pursuant to the provisions of the 
Federal Insecticide, Fungicide, and Rodenticide Act, registered or 
submitted an application for the registration of an economic poison 
consisting of or containing the pesticide chemical for which the 
certification is sought and (b) the request is accompanied by a copy of 
the petition. The person requesting certification may at any time 
withdraw such request for certification.



Sec. 163.5  Material in support of the request for certification.

    In addition to the data required by section 408(d)(1) of the Act to 
be included in the petition, the request for certification should be 
supported by the following material, to the extent it is relied upon by 
the petitioner:
    (a) A complete report of the results of any experimental work by the 
petitioner on the effectiveness of the pesticide chemical for the 
purposes intended;
    (b) Data relating to the usefulness of the pesticide chemical 
obtained by other qualified investigators;
    (c) Any other material which the petitioner believes will justify a 
finding of usefulness.

If such material is fully shown in the petition, it need not be set 
forth separately in the request for certification.



Sec. 163.6  Certification limited to economic poison uses.

    If the product for which a certification is sought is intended for 
both economic poison and noneconomic poison uses, any certification 
relative to the usefulness of such product will refer only to economic 
poison uses. No action will be taken with respect to the noneconomic 
poison uses of such product.



Sec. 163.7  Factors considered in determining usefulness.

    In determining whether a pesticide chemical is useful for the 
purposes for which a tolerance or exemption is sought, consideration 
will be given, among other things, to:
    (a) The results of any experimental work by the petitioner on the 
effectiveness of the pesticide chemical for the purposes intended.
    (b) Data relating to the usefulness of the pesticide chemical 
obtained by other qualified investigators.
    (c) Reports of other experimental work before the Director in 
publications, the official files of the Agency, or otherwise.
    (d) Opinions of experts qualified in the fields involved.

[[Page 160]]



Sec. 163.8  Basis for determination of usefulness.

    Usefulness of a pesticide chemical for the purposes intended will be 
determined upon the basis of its practical pesticidal, or biological, 
effectiveness. Pesticidal effectiveness may be established in terms of 
percentage reduction or control of pests or, when appropriate, increase 
in yield or quality of crop following application of the specified 
pesticide under the conditions prescribed, compared with the results 
from adequate controls. Consideration may also be given to other 
economic gain or practical benefit, including: Economy or ease of 
production, harvest, or storage of crop; flexibility as regards the time 
of planting or harvest, even at the possible sacrifice of yield; and 
general benefit to livestock, plants, or human welfare.



Sec. 163.9  Proposed certification; notice; request for hearing.

    (a) If, upon the basis of the data before him, it appears to the 
Director that the pesticide chemical is not useful for the purpose or 
purposes for which a tolerance or exemption is sought, or is useful for 
only some of the purposes for which a tolerance or exemption is sought, 
the Director shall notify the person requesting the certification of his 
proposal to so certify. Notice of such proposed certification will be 
given by registered mail.
    (b) Within one week after receipt of such notice of proposed 
certification the person requesting the certification may, by filing a 
request with the Director, (1) request that the certification be made on 
the basis of the proposed certification; (2) request a hearing on the 
proposed certification or the parts objected to; (3) request both such 
certification and such hearing; or (4) withdraw the request for 
certification as provided for in Sec. 163.10.

If no such request or withdrawal is filed with the Director within such 
time, the certification will be made as proposed.



Sec. 163.10  Withdrawal of request for certification pending clarification or completion.

    In some cases it may be necessary for the Director to notify the 
petitioner of his proposal to certify that the pesticide chemical does 
not appear to be useful for some or all of the purposes for which a 
tolerance or exemption is sought only because the data submitted by the 
petitioner are not sufficiently clear or complete to justify a finding 
of usefulness. In such cases the petitioner may withdraw his request for 
certification pending its clarification or the obtaining of additional 
data, and no further action will be taken with respect to the making of 
the certification until the request for certification is resubmitted. 
Upon the resubmission of the request for certification, the time 
limitation within which final certification is required to be made will 
begin to run anew from the date of the resubmission.



Sec. 163.11  Registration under the Federal Insecticide, Fungicide, and Rodenticide Act.

    (a) Since in most cases where a pesticide chemical may leave a 
residue in or on a raw agricultural commodity there can be no 
determination of the adequacy of the directions for use or the warning 
or caution statements appearing on the labeling of an economic poison 
until a tolerance or exemption has been established for the pesticide 
chemical which is, or is a part of, such economic poison, it will not 
ordinarily be possible to register the economic poison under the Federal 
Insecticide, Fungicide, and Rodenticide Act until such tolerance or 
exemption has been established.
    (b) Factors other than pesticidal, or biological, effectiveness are 
considered in the granting of registration under the Federal 
Insecticide, Fungicide, and Rodenticide Act. Therefore, the criteria for 
registration are not all applied in considering the certification of 
usefulness, and the fact that such a certification has been made does 
not mean that the economic poison can be registered for the uses 
concerned.



Sec. 163.12  Opinion as to residue.

    (a) In forming an opinion whether the tolerance or exemption 
proposed by the petitioner reasonably reflects the amount of residue 
likely to result when the pesticide chemical is used in the

[[Page 161]]

manner proposed, consideration will be given, among other things, to:
    (1) Data furnished by the petitioner showing (i) the results of 
tests to ascertain the amount of residue remaining, including a 
description of the analytical methods used, and (ii) practicable methods 
for removing residue which exceeds any proposed tolerance;
    (2) Reports of other experimental work before the Director in 
publications, the official files of the Agency, or otherwise;
    (3) Opinions of experts qualified in the fields involved.
    (b) If a tolerance proposed by the petitioner is reasonably to 
reflect the amount of residue likely to result when a pesticide chemical 
is used, it must be large enough to include all residue which is likely 
to result when the pesticide chemical is used in the manner proposed by 
the petitioner, but not larger than needed for this purpose. The 
tolerance proposed by the petitioner may take into account reduction of 
residue by washing, brushing, or other applicable method.
    (c) If there is insufficient information before the Director to 
support an opinion as to whether the tolerance proposed by the 
petitioner reasonably reflects the amount of residue likely to result, 
the opinion will so state.



PART 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--Table of Contents




                           Subpart A--General

Sec.
164.1  Number of words.
164.2  Definitions.
164.3  Scope and applicability of this part.
164.4  Arrangements for examining Agency records, transcripts, orders, 
          and decisions.
164.5  Filing and service.
164.6  Time.
164.7  Ex parte discussion of proceeding.
164.8  Publication.

Subpart B--General Rules of Practice Concerning Proceedings (Other Than 
                           Expedited Hearings)

                       Commencement of Proceeding

164.20  Commencement of proceeding.
164.21  Contents of a denial of registration, notice of intent to cancel 
          a registration, or notice of intent to change a 
          classification.
164.22  Contents of document setting forth objections.
164.23  Contents of the statement of issues to accompany notice of 
          intent to hold a hearing.
164.24  Response to the Administrator's notice of intention to hold a 
          hearing.
164.25  Filing copies of notification of intent to cancel registration 
          or change classification or refusal to register, and statement 
          of issues.

              Appearances, Intervention, and Consolidation

164.30  Appearances.
164.31  Intervention.
164.32  Consolidation.

                        Administrative Law Judge

164.40  Qualifications and duties of Administrative Law Judge.

                   Prehearing Procedures and Discovery

164.50  Prehearing conference and primary discovery.
164.51  Other discovery.

                                 Motions

164.60  Motions.

                       Subpoenas and Witness Fees

164.70  Subpoenas.
164.71  Fees of witnesses.

                              The Hearings

164.80  Order of proceeding and burden of proof.
164.81  Evidence.
164.82  Transcripts.

                     Initial or Accelerated Decision

164.90  Initial decision.
164.91  Accelerated decision.

                                 Appeals

164.100  Appeals from or review of interlocutory orders or rulings.
164.101  Appeals from or review of initial decisions.
164.102  Appeals from accelerated decisions.
164.103  Final decision or order on appeal or review.

[[Page 162]]

164.110  Motion for reopening hearings; for rehearing; for reargument of 
          any proceeding; or for reconsideration of order.
164.111  Procedure for disposition of motions.

       Subpart C--General Rules of Practice for Expedited Hearings

164.120  Notification.
164.121  Expedited hearing.
164.122  Final order and order of suspension.
164.123  Emergency order.

Subpart D--Rules of Practice for Applications Under Sections 3 and 18 To 
            Modify Previous Cancellation or Suspension Orders

164.130  General.
164.131  Review by Administrator.
164.132  Procedures governing hearing.
164.133  Emergency waiver of hearing.

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

    Source: 38 FR 19371, July 20, 1973, unless otherwise noted.



                           Subpart A--General



Sec. 164.1  Number of words.

    As used in this part, a word in the singular form shall be deemed to 
import the plural, and vice versa, as the case may require.



Sec. 164.2  Definitions.

    For the purposes of this part, the following terms shall be defined, 
as listed below:
    (a) The term Act means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (86 Stat. 973) and other legislation 
supplementary thereto and amendatory thereof.
    (b) The term Administrative Law Judge means an Administrative Law 
Judge appointed pursuant to 5 U.S.C. 3105 (see also 5 CFR part 930, as 
amended), and such term is synonymous with the term ``Hearing Examiner'' 
as used in the Act or in the United States Code.
    (c) The term Administrator means the Administrator of the United 
States Environmental Protection Agency.
    (d) The term Agency, unless otherwise specified, means the United 
States Environmental Protection Agency.
    (e) The term Applicant means any person who has made application to 
have a pesticide registered or classified pursuant to the provisions of 
the Act.
    (f) The term Committee means a group of qualified scientists 
designated by the National Academy of Sciences according to agreement 
under the Act to submit an independent report to the Administrative Law 
Judge on questions of scientific fact referred from a hearing under 
subpart B of this part.
    (g) Environmental Appeals Board shall mean the Board within the 
Agency described in Sec. 1.25 of this title. The Administrator delegates 
authority to the Environmental Appeals Board to issue final decisions in 
appeals filed under subparts B and C of this part. An appeal directed to 
the Administrator, rather than to the Environmental Appeals Board, will 
not be considered. This delegation does not preclude the Environmental 
Appeals Board from referring an appeal or a motion under subparts B and 
C to the Administrator when the Environmental Appeals Board, in its 
discretion, deems it appropriate to do so. When an appeal or motion is 
referred to the Administrator, all of the parties shall be so notified 
and the rules in subparts B and C referring to the Environmental Appeals 
Board shall be interpreted as referring to the Administrator.
    (h) The term Expedited Hearing means a hearing commenced as the 
result of the issuance of a notice of intention to suspend or the 
suspension of a registration of a pesticide by an emergency order, and 
is limited to a consideration as to whether a pesticide presents an 
imminent hazard which justifies such suspension.
    (i) The term Hearing means a public hearing which is conducted 
pursuant to the provisions of chapter 5, subchapter II of title 5 of the 
United States Code and the regulations of this part.
    (j) The term Hearing Clerk means the Hearing Clerk, Environmental 
Protection Agency, Washington, DC 20460.
    (k) The term Initial Decision means the decision of the 
Administrative Law Judge supported by findings of fact and conclusions 
regarding all material issues of law, fact, or discretion, as well as 
reasons therefor. Such decision shall become the final decision and 
order of the Administrator without further proceedings unless an appeal

[[Page 163]]

therefrom is taken or the Administrator orders review thereof as herein 
provided.
    (l) The term Judicial Officer means an officer or employee of the 
Agency designated as a judicial officer, pursuant to these rules, who 
shall meet the qualifications and perform functions as herein provided.
    (1) Office. There may be designated for the Agency one or more 
judicial officers, one of whom may be Chief Judicial Officer. As work 
requires, there may be a judicial officer designated to act for the 
purpose of a particular case. All prior designations of judicial officer 
shall stay in force until further notice.
    (2) Qualification. A judicial officer shall be a permanent or 
temporary employee or officer of the Agency who may perform other duties 
for the Agency. Such judicial officer shall not be employed by the 
Office of Hazardous Materials Control or have any connection with the 
preparation or presentation of evidence for a hearing.
    (3) Functions. The Administrator may delegate any or part of his 
authority to act in a given case under subparts B and C of this part to 
a judicial officer. The Administrator can separately delegate his 
authority to rule on interlocutory orders and motions, and may also 
delegate his authority to make findings of fact and draw conclusions of 
law in a particular proceeding, providing that this delegation shall not 
preclude the Judicial Officer from referring any motion or case to the 
Administrator when the Judicial Officer determines such referral to be 
appropriate. The Administrator, in deciding a case himself, may consult 
with and assign the preliminary drafting of conclusions of law and 
findings of fact to any judicial officer.
    (m) The term Party means any person, group, organization, or Federal 
agency or department that participates in a hearing.
    (n) The term Person includes any individual, partnership, 
association, corporation, and any organized group of persons, whether 
incorporated or not.
    (o) The term Petitioner means any person adversely affected by a 
notice of the Administrator who requests a public hearing.
    (p) The term Presiding Officer means any person designated by the 
Administrator to conduct an expedited hearing.
    (q) The term Recommended Decision means the recommended findings and 
conclusions of the Presiding Officer in an expedited hearing.
    (r) The term Registrant means any person who has registered a 
pesticide pursuant to the provisions of the Act.
    (s) The term Respondent means the Assistant Administrator of the 
Office of Hazardous Materials Control of the Agency.

Terms defined in the act and not explicitly defined herein are used 
herein with the meanings given in the act.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992; 57 
FR 30657, July 10, 1992]



Sec. 164.3  Scope and applicability of this part.

    The provisions of subpart B of this part shall govern proceedings, 
conducted pursuant to the provisions of the Act, concerning refusals to 
register, cancellations of registration, changes of classifications or 
hearings called by the Administrator; the provisions of subpart C of 
this part shall govern suspension proceedings conducted pursuant to the 
provisions of the Act.



Sec. 164.4  Arrangements for examining Agency records, transcripts, orders, and decisions.

    (a) Reporting of orders, decisions, and other signed documents. All 
orders, decisions, or other signed documents required by the rules in 
this part, whether issued by the Environmental Appeals Board or the 
Presiding Officer shall be made available to the public.
    (b) Establishment of an Agency repository. In addition, all 
transcripts and docket entries shall become part of the official docket 
and shall be retained by the hearing clerk. At least two copies of all 
final orders, decisions and a notification of any appeals taken 
therefrom shall be retained by the hearing clerk and filed 
chronologically and shall be periodically bound and indexed. All the 
above documents shall be made available to the public for reasonable 
inspections during Agency business hours.

[[Page 164]]

    (c) Whenever any information or data is required to be produced or 
examined and any party to the proceeding claims that such information is 
a trade secret or commercial or financial information, other than 
information relating to the formulas of a pesticide, the Administrative 
Law Judge, the Presiding Officer, or the Environmental Appeals Board may 
require production or testimony in camera and sealed to all but the 
parties.
    (d) All orders, decisions, or other documents made or signed by the 
Administrative Law Judge, the Presiding Officer, or the Environmental 
Appeals Board shall be filed with the hearing clerk. The hearing clerk 
shall immediately serve all parties with a copy of such order, decision, 
or other document.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.5  Filing and service.

    (a) All documents or papers required or authorized to be filed, 
shall be filed with the hearing clerk, except as provided otherwise in 
this part. At the same time that a party files documents or papers with 
the clerk, it shall serve upon all other parties copies thereof, with a 
certificate of service on each document or paper, including those filed 
with the hearing clerk. If filing is accomplished by mail addressed to 
the clerk, filing shall be deemed timely if the papers are postmarked on 
the due date except as to initial filings requesting a public hearing or 
responding to a notice of intent to hold a hearing, in which case such 
filings must be received by the hearing clerk either within the time 
required by statute or by the notice of intent to hold a hearing.
    (b) Each document filed, other than papers commencing a proceeding, 
shall contain the FIFRA docket number and, if the document affects less 
than all of the registrations included under that docket number, the 
registration number or file symbol of each product which is the subject 
of the document.
    (c) In addition to copies served on all other parties, each party 
shall file an original and two copies of all papers with the hearing 
clerk.



Sec. 164.6  Time.

    (a) Computation. In computing any period of time prescribed or 
allowed by these rules, except as otherwise provided, the day of the 
act, event, or default from which the designated period of time begins 
to run shall not be included. Saturdays, Sundays, and legal holidays 
shall be included in computing the time allowed for the filing of any 
document or paper, except that when such time expires on a Saturday, 
Sunday, or legal holiday, such period shall be extended to include the 
next following business day.
    (b) Enlargement. When by these rules or by order of the 
Administrative Law Judge, the Presiding Officer, or the Environmental 
Appeals Board, an act is required or allowed to be done at or within a 
specified time, the Administrative Law Judge (before his initial 
decision is filed), or the Presiding Officer (before his recommended 
decision is filed), or the Environmental Appeals Board (after the 
Administrative Law Judge's initial decision or the presiding officer's 
recommended decision is filed), for cause shown may at any time in their 
discretion: with or without motion or notice, order the period enlarged 
if request therefor, which may be made ex parte, is made before the 
expiration of the period originally prescribed or as extended by a 
previous order; or on motion made after the expiration of the specified 
period, permit the act to be done where the failure to act was the 
result of excusable neglect. In this connection, consideration shall be 
given to the fact that, under the provisions of the act, the 
Administrator must issue his order not later than 90 days after the 
completion of the hearing, unless all parties agree by stipulation to 
extend this period of time pursuant to Sec. 164.103.
    (c) Additional time after service by mail. A prescribed period of 
time within which a party is required or permitted to do an act shall be 
computed from the time of service, except that when the service is made 
by mail, 3 days shall be added to the prescribed period. Such addition 
for service by mail shall not apply in the case of filing initial 
requests for hearings or responding to a notice of intent to hold a 
hearing, in which cases statutory filing times will

[[Page 165]]

run from the date of the return receipt pursuant to Sec. 164.8.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.7  Ex parte discussion of proceeding.

    At no stage of a proceeding shall the Administrator, the members of 
the Environmental Appeals Board, the Presiding Officer, or the 
Administrative Law Judge discuss ex parte the merits of the proceeding 
with any party or with any person who has been connected with the 
preparation or presentation of the proceeding as an advocate, or in an 
investigative or expert capacity, or with any representative of such 
person, Provided, That the Environmental Appeals Board, the Presiding 
Officer, or the Administrative Law Judge may discuss the merits of the 
case with any such person if all parties to the proceeding, or their 
representatives, have been given reasonable notice and opportunity to be 
present. Any memorandum or other communication addressed to the 
Administrator, the Environmental Appeals Board, the Presiding Officer, 
or the Administrative Law Judge during the pendency of the proceeding, 
and relating to the merits thereof, by or on behalf of any party, shall 
be regarded as an argument made in the proceeding. The Administrator, 
the Environmental Appeals Board, the Presiding Officer, or the 
Administrative Law Judge shall cause any such communication to be filed 
with the hearing clerk and served upon all other parties to the 
proceeding who will be given the opportunity to file an answer thereto.

[57 FR 5342, Feb. 13, 1992]



Sec. 164.8  Publication.

    All notices of intention to cancel a registration, all notices of 
intention to change a classification, and all denials of registrations, 
all together with the reasons (including the factual basis therefor), 
and all notices of intention by the Administrator to hold a hearing, 
together with the statement of issues as provided by Sec. 164.20(b) 
shall be sent to the registrant or applicant by registered or certified 
mail (return receipt requested), and published by appropriate 
announcement in the Federal Register by the Administrator. The 
Administrative Law Judge shall cause to be published in the Federal 
Register by appropriate announcement, a notice of the filing of any 
objections, pursuant to Sec. 164.20(b) or responses pursuant to 
Sec. 164.24, and a notice of the public hearing as provided by 
Sec. 164.80 et seq. Said notice of public hearing shall designate the 
place where the hearing will be held and specify the time when the 
hearing will commence. The hearing shall convene at the place and time 
announced in the notice, unless amended by subsequent notice published 
in the Federal Register, but thereafter it may be moved to a different 
place and may be continued from day to day or recessed to a later day 
without other notice than announcement thereof at the hearing.



Subpart B--General Rules of Practice Concerning Proceedings (Other Than 
                           Expedited Hearings)

                       Commencement of Proceeding



Sec. 164.20  Commencement of proceeding.

    (a) A proceeding shall be commenced whenever a hearing is requested 
by any person adversely affected by a notice of the Administrator of his 
refusal to register or of his intent to cancel the registration or to 
change the classification of a pesticide. A proceeding shall likewise be 
commenced whenever the Administrator decides to call a hearing to 
determine whether or not the registration of a pesticide should be 
canceled or its classification changed. Such request or notice of intent 
to hold a hearing shall be timely filed with the hearing clerk, and the 
matter shall be docketed and assigned a FIFRA docket number.
    (b) If a request for a hearing is filed, the person filing the 
request shall, at the same time, file a document stating his objections 
to the Administrator's refusal to register or his intent to cancel the 
registration or to change the classification of a pesticide. If a notice 
of intent to hold a hearing is filed by the Administrator, he shall, at 
the same time, file a statement of issues.

[[Page 166]]

    (c) Upon the filing of any objections or notice of intent to hold a 
hearing, the proceeding shall be referred to the Chief Administrative 
Law Judge by the hearing clerk. The Chief Administrative Law Judge shall 
refer the proceeding to himself or another Administrative Law Judge who 
shall thereafter be in charge of all further matters concerning the 
proceedings, except as otherwise provided for by order of the Chief 
Administrative Law Judge, the Administrator, or the Environmental 
Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 
57 FR 5342, Feb. 13, 1992]



Sec. 164.21  Contents of a denial of registration, notice of intent to cancel a registration, or notice of intent to change a classification.

    (a) Contents. The denial of registration or a notice of intent to 
cancel a registration or to change a classification shall be accompanied 
by the reasons (including the factual basis) for the action.
    (b) Amendments to contents of denials and notices. Such documents 
under this section may be amended or enlarged by the Administrator at 
any time prior to the commencement of the public hearing. If the 
Administrative Law Judge determines that additional time is necessary to 
permit a party to prepare for matters raised by such amendments, the 
commencement of the hearing shall be delayed for an appropriate period.



Sec. 164.22  Contents of document setting forth objections.

    (a) Concise statement required. Any document containing objections 
to an order of the Administrator of his refusal to register, or his 
intent to cancel the registration, or change the classification of a 
pesticide, shall clearly and concisely set forth such objections and the 
basis for each objection, including relevant allegations of fact 
concerning the pesticide under consideration. The document shall 
indicate the registration number of the pesticide, if applicable, a copy 
of the currently accepted and/or proposed labeling and a list of the 
currently registered or proposed uses of said pesticide.
    (b) Amendments to objections byleave. Objections may be amended at 
any time prior to the commencement of the public hearing by leave of the 
Administrative Law Judge or by written consent of all parties. The 
Administrative Law Judge shall freely grant such leave when justice so 
requires. If the Administrative Law Judge determines that additional 
time is necessary to permit a party to prepare for matters raised by 
amendments to objections, the commencement of the hearing shall be 
delayed for an appropriate period. This subsection shall not permit the 
addition, beyond the statutory deadline, of registered pesticides which 
are not included in the objections filed pursuant to paragraph (a) of 
this section.
    (c) Amendments to objections as a matter of right. Objections may be 
amended as a matter of right within 30 days, or in such time as the 
Administrator shall designate, after the Administrator amends his notice 
of intent to cancel a registration, change a classification, or his 
refusal to register a pesticide.



Sec. 164.23  Contents of the statement of issues to accompany notice of intent to hold a hearing.

    (a) Concise statement required. The statement of issues by the 
Administrator shall set a time in which any person wishing to 
participate in the hearing shall file a written response to the 
statement of issues as provided by Sec. 164.24. The statement of issues 
shall include questions as to which evidence shall be taken at the 
hearing. Those questions may include questions concerning whether a 
pesticide's registration should be canceled or its classification 
changed, whether its composition is such as to warrant the claims for 
it, whether its labeling and other material submitted comply with the 
requirements of the Act, whether it will perform its intended function 
without unreasonable adverse effects on the environment, and whether, 
when used in accordance with widespread and commonly recognized 
practice, it will or will not generally cause unreasonable adverse 
effects on the environment.

[[Page 167]]

    (b) Amendment to statement of issues. The statement of issues may be 
amended or enlarged by the Administrator at any time prior to the 
commencement of the public hearing. If the Administrative Law Judge 
determines that additional time is necessary to permit a party to 
prepare for matters raised by amendments or enlargements to the 
statement of issues, the commencement of the hearing shall be delayed 
for an appropriate period.



Sec. 164.24  Response to the Administrator's notice of intention to hold a hearing.

    Any person wishing to participate in any proceeding commenced 
pursuant to any notice by the Administrator of intention to hold a 
hearing, shall file with the hearing clerk, within the time set by the 
Administrator in the notice (in no case less than 30 days from the date 
of the notice), a written response to the statement of issues which 
shall include the position and interest of such person with respect 
thereto. If any such person is a registrant or an applicant for 
registration, he shall also file the registration number of the 
pesticide, if applicable, a copy of the currently accepted and/or 
proposed labeling and a list of the currently registered or proposed 
uses of said pesticide.



Sec. 164.25  Filing copies of notification of intent to cancel registration or change classification or refusal to register, and statement of issues.

    After a copy of the document setting forth the objections and 
requesting a public hearing is filed with the hearing clerk or a 
response to the statement of issues is filed, the hearing clerk shall 
serve a copy of the document upon Respondent and the Office of the 
General Counsel of the Agency, Respondent shall, by counsel, thereupon 
file with the hearing clerk a copy of the appropriate notice of 
intention to cancel, the notice of intention to change the 
classification or the registration refusal order.

              Appearances, Intervention, and Consolidation



Sec. 164.30  Appearances.

    Representatives. Parties may appear in person or by counsel or other 
representative. Persons who appear as counsel or in a representative 
capacity must conform to the standards of ethical conduct required of 
practitioners before the courts of the United States.



Sec. 164.31  Intervention.

    (a) Motion. Any person may file a motion for leave to intervene in a 
hearing conducted under this subpart. A motion must set forth the 
grounds for the proposed intervention, the position and interest of the 
movant in the proceeding and the documents proposed to be filed pursuant 
to either Sec. 164.22 or Sec. 164.24.
    (b) When filed. A motion for leave to intervene in a hearing must 
ordinarily be filed prior to the commencement of the first prehearing 
conference. Any motion filed after that time must contain, in addition 
to the information set forth in paragraph (a) of this section, a 
statement of good cause for the failure to file the motion prior to the 
commencement of the first prehearing conference, and shall be granted 
only upon a finding (1) that extraordinary circumstances justify the 
granting of the motion, or (2) that the intervenor shall be bound by 
agreements, arrangements, and other matters previously made in the 
proceeding.
    (c) Disposition. Leave to intervene will be freely granted but only 
insofar as such leave raises matters which are pertinent to and do not 
unreasonably broaden the issues already presented. If leave is granted, 
the movant shall thereby become a party with the full status of the 
original parties to the proceedings. If leave is denied, the movant may 
request that the ruling be certified to the Environmental Appeals Board, 
pursuant to Sec. 164.100 for a speedy appeal.
    (d) Amicus curiae. Persons not parties to the proceedings wishing to 
file briefs may do so by leave of the Administrative Law Judge granted 
on motion. A

[[Page 168]]

motion for leave shall identify the interest of the applicant and shall 
state the reasons why the proposed amicus brief is desirable. Unless all 
parties otherwise consent, an amicus curiae shall file its brief within 
the time allowed the party whose position the brief will support. Upon a 
showing of good cause, the Administrator or Administrative Law Judge may 
grant permission for later filing.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992]



Sec. 164.32  Consolidation.

    The Chief Administrative Law Judge, by motion or sua sponte, may 
consolidate two or more proceedings whenever it appears that this will 
expedite or simplify consideration of the issues. Consolidation shall 
not affect the right of any party to raise issues that could have been 
raised if consolidation had not occurred. At the conclusion of 
proceedings consolidated under this section, the Administrative Law 
Judge shall issue one decision under Sec. 164.90 unless one or more of 
the consolidated proceedings have been dismissed pursuant to 
Sec. 164.91.

                        Administrative Law Judge



Sec. 164.40  Qualifications and duties of Administrative Law Judge.

    (a) Qualifications. The Administrative Law Judge shall have the 
qualifications required by statute. He shall not decide any matter in 
connection with a proceeding where he has a financial interest in any of 
the parties or a relationship with a party that would make it otherwise 
inappropriate for him to act.
    (b) Disqualification of the Administrative Law Judge. (1) Any party 
may, by motion made to the Administrative Law Judge, as soon as 
practicable, request that he disqualify himself and withdraw from the 
proceeding. The Administrative Law Judge shall then rule upon the motion 
and, upon request of the movant, shall certify an adverse ruling for 
appeal.
    (2) Withdrawal sua sponte. The Administrative Law Judge may at any 
time withdraw from any proceedings in which he deems himself 
disqualified for any reason.
    (c) Conduct. The Administrative Law Judge shall conduct the 
proceeding in a fair and impartial manner subject to the precepts of the 
Canons of Judicial Ethics of the American Bar Association.
    (d) Power. Subject to review, as provided elsewhere in this part, 
the Administrative Law Judge shall have power to take actions and 
decisions in conformity with statute or in the interests of justice. The 
Administrative Law Judge shall not interrupt the recording of the 
proceedings on the record over the objection of any party.
    (e) Absence or change of the Administrative Law Judge. In the case 
of the absence or unavailability of the Administrative Law Judge, or his 
inability to act, or his removal by disqualification or withdrawal, the 
powers and duties to be performed by him under this part in connection 
with a hearing assigned to him may, unless otherwise directed by the 
Administrator, be assigned to another Administrative Law Judge so 
designated to act by the Chief Administrative Law Judge, the 
Administrator or the Environmental Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 
57 FR 5342, Feb. 13, 1992]

                   Prehearing Procedures and Discovery



Sec. 164.50  Prehearing conference and primary discovery.

    (a) Purpose of the prehearing conference. Except as otherwise 
provided in paragraph (d) of this section, the Administrative Law Judge 
shall, prior to the commencement of the hearing and for the purpose of 
expediting the hearing, file with the hearing clerk an order for a 
prehearing conference. More than one such conference may be held. Such 
order or orders shall direct the parties or their counsel to appear at a 
specified time and place to consider:
    (1) The simplification of issues including listing of specific uses 
to be contested;
    (2) The necessity or desirability of amendments to the objections or 
statement of issues, or any document filed in response thereto;

[[Page 169]]

    (3) The possibility of obtaining stipulations of fact and documents 
which will avoid unnecessary delay;
    (4) Matters of which official notice may be taken;
    (5) The limitation of the number of expert and other witnesses;
    (6) Procedure at the hearing except as so provided in 
Sec. 164.80(a);
    (7) The use of verified written statements in lieu of oral direct 
testimony;
    (8) The intent of any party to request a scientific advisory 
committee as defined in Sec. 164.2(f);
    (9) The issuance of subpoenas and subpoenas duces tecum for 
discovery and hearing purposes;
    (10) A setting of a time and place for the public hearing, after 
giving careful consideration to the convenience of all the parties, the 
witnesses, the public interest and the necessity for notice in the 
Federal Register as provided by Sec. 164.8; and
    (11) Any other matter that may expedite the hearing or aid in the 
disposition of the proceeding.
    (b) Primary discovery (Exchange of witness lists and documents). At 
a prehearing conference or within some reasonable time set by the 
Administrative Law Judge prior to the hearing, each party shall make 
available to the other parties the names of the expert and other 
witnesses the party expects to call, together with a brief narrative 
summary of their expected testimony and a list of all documents and 
exhibits which the party expects to introduce into evidence. Thereafter, 
witnesses, documents, or exhibits may be added and narrative summaries 
of expected testimony amended upon motion by a party.
    (c) Record of the prehearing conference. No transcript of any 
prehearing conference shall be made unless a request therefor by one of 
the parties is granted by the Administrative Law Judge. Such party shall 
bear the cost of the taking of the transcript unless otherwise ordered 
by the Administrative Law Judge. The Administrative Law Judge shall 
prepare and file for the record a written report of the action taken at 
each conference, which shall incorporate any stipulations or agreements 
made by the parties at or as a result of such conference, all rulings 
upon matters considered at such conference and appropriate orders.
    (d) Unavailability of a prehearing conference. Upon a finding that 
circumstances render a prehearing conference unnecessary, or 
impracticable, or upon a finding that a prehearing conference would 
serve primarily to delay the proceedings rather than to expedite them, 
the Administrative Law Judge, on motion or sua sponte, may order that 
the prehearing conference not be held. In these circumstances he may 
request the parties to correspond with him for the purpose of 
accomplishing any of the objectives set forth in this section. Such 
correspondence shall not be made a part of the record, but the 
Administrative Law Judge shall submit a written summary for the record 
if any action is taken.
    (e) Submission of questions to an advisory committee--(1) General. 
At any prehearing conference, or if none is held prior to the public 
hearing, except as herein provided, the Administrative Law Judge shall 
determine whether any party desires that questions of scientific fact be 
referred to a committee designated by the National Academy of Sciences.
    (2) Preparation of questions. On determining an affirmative intent, 
the Administrative Law Judge shall direct all parties to file and serve, 
within a time period subject to his discretion, proposed questions of 
scientific fact accompanied by reasons supporting their submission to 
said committee. Within 10 days of the service of such proposed 
questions, together with their supporting reasons, any party may respond 
in writing to the proposed submission of the questions to the said 
committee. The Administrative Law Judge shall determine whether or not a 
reference of questions of scientific fact to said committee is necessary 
or desirable. In the event he decides such reference is necessary or 
desirable, he shall so inform the National Academy in writing, and shall 
prepare in his discretion appropriate questions. If any of the questions 
prepared are not in substance based upon the submissions of the parties, 
the Administrative Law Judge shall permit any party 10 days after their 
preparation to respond in writing to the proposed submission of

[[Page 170]]

said question or questions. He shall then determine whether such 
questions should be referred to the committee.
    (3) Reference and report. Not less than 30 days after he has 
informed the National Academy that questions of scientific fact will be 
referred to it, the Administrative Law Judge shall refer the questions 
of scientific fact as prepared. The committee shall report in writing to 
the Administrative Law Judge within 60 days after such referral on these 
questions of scientific fact and the report, its record and any other 
matter transmitted as provided for by the Administrator's agreement with 
the National Academy of Sciences shall be made public and considered as 
part of the hearing record.
    (4) Request and submission subsequent to prehearing conference. At 
any time before the hearing is closed, the Administrative Law Judge or a 
party by motion may request that questions of scientific fact not 
previously referred be referred, or that questions previously referred 
be amended or expanded. The Administrative Law Judge may refer such 
questions if he finds that good cause exists and that reference of such 
questions is necessary or desirable.

[38 FR 19371, July 20, 1973, as amended at 39 FR 11884, Apr. 1, 1974]



Sec. 164.51  Other discovery.

    (a) General. Except as so provided by Sec. 164.50(b) supra, further 
discovery, under this subpart, shall be permitted only upon 
determination by the Administrative Law Judge (1) that such discovery 
shall not in any way unreasonably delay the proceeding, (2) that the 
information to be obtained is not otherwise obtainable and (3) that such 
information has significant probative value. The Administrative Law 
Judge shall be guided by the procedures set forth in the Federal Rules 
of Civil Procedure, where practicable, and the precedents thereunder, 
except that no discovery shall be undertaken except upon order of the 
Administrative Law Judge or upon agreement of the parties.
    (b) Depositions upon oral questions. The Administrative Law Judge 
shall order depositions upon oral questions only upon a showing of good 
cause and upon a finding that (1) the information sought cannot be 
obtained by alternative methods, or (2) there is a substantial reason to 
believe that relevant and probative evidence may otherwise not be 
preserved for presentation by a witness at the hearing.
    (c) Procedure. (1) Any party to the proceeding desiring discovery 
shall make a motion or motions therefor. Such a motion shall set forth 
(i) the circumstances warranting the taking of the discovery, (ii) the 
nature of the information expected to be discovered and (iii) the 
proposed time and place where it will be taken.
    (2) If the Administrative Law Judge determines the motion should be 
granted, he shall issue an order and appropriate subpoenas, if 
necessary, for the taking of such discovery together with the conditions 
and terms thereof.

                                 Motions



Sec. 164.60  Motions.

    (a) General. All motions, except those made orally during the course 
of a public hearing or as otherwise provided by this part, shall be in 
writing and shall state with particularity the grounds therefor, shall 
set forth the relief or order sought, and shall be filed with the 
hearing clerk and served on all parties.
    (b) Response to motions. Within 10 days after service of any motion 
filed pursuant to this part, or within such other time as may be fixed 
by the Administrator, his designee, or the Administrative Law Judge, any 
party may serve and file an answer to the motion. The movant shall, if 
requested by the Administrator, his designee, or the Administrative Law 
Judge, serve and file reply papers within the time set by the request.
    (c) Decision. The Administrative Law Judge shall rule upon all 
motions filed or made prior to the filing of his initial or accelerated 
decision at the time of filing on ex parte motions or where the movant 
has stated that no party objects to the granting of such motion. 
Otherwise, such decision shall await the answering papers and reply 
papers if permitted. The Environmental Appeals Board shall rule upon all 
motions

[[Page 171]]

filed after the filing of the initial or accelerated decision. Oral 
argument of motions will be permitted only if the Administrative Law 
Judge or the Environmental Appeals Board deems it necessary.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]

                       Subpoenas and Witness Fees



Sec. 164.70  Subpoenas.

    (a) The attendance of witnesses or the production of documentary 
evidence may, by subpoena, be required at any designated place of 
hearing or place of discovery. Subpoenas may be issued by the 
Administrative Law Judge sua sponte or upon a showing by an applicant 
that evidence sought for hearing is relevant and material to the issues 
involved in the hearing or that the sought discovery pursuant to 
Sec. 164.51 meets the standards set forth therein. The Administrative 
Law Judge shall be guided by the principles of the Federal Rules of 
Civil Procedure in making any order for the protection of a witness or 
the content of the documents produced.
    (b) Motion for subpoena duces tecum. Subpoenas for the production of 
documentary evidence, unless issued by the Administrative Law Judge sua 
sponte, shall be issued only upon a written motion. Such motion shall 
specify, as exactly as possible, the documents desired.
    (c) Service of subpoenas. Subpoenas shall be served as provided by 
the Federal Rules of Civil Procedure.



Sec. 164.71  Fees of witnesses.

    Witnesses summoned before the Administrative Law Judge shall be paid 
the same fees and mileage that are paid witnesses in the courts of the 
United States, and persons whose depositions are taken, and the persons 
taking the same, shall be entitled to the same fees as are paid for like 
services in the courts of the United States. Fees shall be paid by the 
party at whose instance the witness appears or the deposition is taken.

                              The Hearings



Sec. 164.80  Order of proceeding and burden of proof.

    (a) At the hearing, the proponent of cancellation or change in 
classification has the burden of going forward to present an affirmative 
case for the cancellation or change in classification of the 
registration. In the case of the denial of an application for 
registration, the applicant shall have the burden of going forward. In 
the case of a hearing called by the Administrator, the Respondent has 
the burden of going forward to present an affirmative case as to the 
statement of issues. The party having the burden of going forward shall 
have the opportunity to submit evidence on rebuttal.
    (b) On all issues arising in connection with the hearing, the 
ultimate burden of persuasion shall rest with the proponent of the 
registration.
    (c) If any party, other than Respondent, after being duly notified, 
fails to appear at the hearing, he shall be deemed to have authorized 
the Administrative Law Judge to dismiss the proceeding with or without 
prejudice, as the Administrative Law Judge may determine, unless a 
motion excusing the failure to appear has been made and granted. In the 
event that a party appears at the hearing and no representative of the 
Agency appears, the Administrative Law Judge shall proceed ex parte to 
hear the evidence of the party: Provided, That failure on the part of 
Respondent to appear at a hearing shall not be deemed to be a waiver of 
Respondent's right to file proposed findings of fact, conclusions of law 
and orders, to be served with a copy of the Administrative Law Judge's 
initial or accelerated decision, and to file exceptions with and to 
submit argument before the Administrator with respect thereto.



Sec. 164.81  Evidence.

    (a) General. The Administrative Law Judge shall admit all relevant, 
competent and material evidence, except evidence that is unduly 
repetitious. Relevant, competent and material evidence may be received 
at any hearing even though inadmissible under the rules of evidence 
applicable to judicial

[[Page 172]]

proceedings. The weight to be given evidence shall be determined by its 
reliability and probative value. In all hearings the testimony of 
witnesses shall be taken orally, except as otherwise provided by these 
rules or by the Administrative Law Judge. Parties, however, shall have 
the right to cross-examine a witness who appears at the hearing, 
provided that such cross examination is not unduly repetitious.
    (b) Report of a committee of the National Academy of Sciences. If 
questions have been submitted to a committee designated by the National 
Academy pursuant to Sec. 164.50(e), the report of the committee, other 
material that may be required by the Administrator and a list of 
witnesses and evidence relied upon shall be received into evidence and 
made part of the record of the hearing. Objections to the report may 
also be made part of the record and go to the weight of its evidentiary 
value.
    (c) Objections. If a party objects to the admission or rejection of 
any evidence or the limitation of the scope of any examination or cross-
examination, he shall state briefly the grounds for such objection. The 
transcript shall include any argument or debate thereon, unless the 
Administrative Law Judge, with the consent of all parties, orders that 
such argument not be transcribed. The ruling and the reasons given 
therefor by the Administrative Law Judge on any objection shall be a 
part of the transcript. An automatic exception to that ruling will 
follow.
    (d) Exhibits. Except where the Administrative Law Judge finds that 
the furnishing of copies is impracticable, a copy of each exhibit filed 
with the Administrative Law Judge shall be furnished to each other 
party. A true copy of an exhibit may, in the discretion of the 
Administrative Law Judge, be substituted for the original.
    (e) Official Notice. Official notice may be taken of Agency 
proceedings, any matter judicially noticed in the Federal courts, and of 
other facts within the specialized knowledge and experience of the 
Agency. Any active party shall be given adequate opportunity to show 
that such facts are erroneously noticed by presenting evidence to the 
contrary.
    (f) Offer of proof. Whenever evidence is deemed inadmissible, the 
party offering such evidence may make an offer of proof, which shall be 
included in the transcript. The offer of proof for excluded oral 
testimony shall consist of a brief statement describing the nature of 
the evidence excluded. If the evidence consists of a document or 
exhibit, it shall be inserted in the record in total. In the event the 
Environmental Appeals Board decides that the Administrative Law Judge's 
ruling in excluding the evidence was erroneous and prejudicial, the 
hearings may be reopened to permit the taking of such evidence, or where 
appropriate, the Environmental Appeals Board may evaluate the evidence 
and proceed to a final decision.
    (g) Verified statements. With the approval of the Administrative Law 
Judge, a witness may insert into the record, as his testimony, 
statements of fact or opinion prepared by him or written answers to 
interrogatories of counsel, or may submit as an exhibit his prepared 
statement, provided that such statements or answers must not include 
legal argument. Before any such statement or answer is read or admitted 
into evidence the witness shall deliver to the Administrative Law Judge, 
the reporter, and opposing counsel a copy of such. The admissibility of 
the evidence contained in such statement shall be subject to the same 
rules as if such testimony were produced in the usual manner and the 
witness shall be subject to oral cross-examination on the contents of 
such statements. Approval for such a procedure may be denied when it 
appears to the Administrative Law Judge that the memory or the demeanor 
of the witness is of importance.

[38 FR 19371, July 20, 1973, as amended at 40 FR 25815, June 19, 1975; 
57 FR 5343, Feb. 13, 1992]



Sec. 164.82  Transcripts.

    (a) Filing and certification. Hearings shall be stenographically 
reported, transcribed and made available to the public as required by 
statute or Agency regulations. As soon as practicable after the taking 
of the last evidence, the Administrative Law Judge shall certify (1) 
that the original transcript

[[Page 173]]

is a true transcript of the testimony offered or received at the 
hearing, except in such particulars as he shall specify and (2) that the 
exhibits accompanying the transcript are all the exhibits introduced at 
the hearing, with such exceptions as he shall specify. A copy of such 
certificate shall be attached to each of the copies of the transcript.
    (b) [Reserved]

                     Initial or Accelerated Decision



Sec. 164.90  Initial decision.

    (a) Proposed findings of fact, conclusions, and order. Within 20 
days after the last evidence is taken in a hearing, each party may file 
with the hearing clerk proposed orders, findings of fact, and 
conclusions of law based solely on the record, and a brief in support 
thereof. Within 10 days thereafter, each party may file a reply brief. 
The Administrative Law Judge may, in his discretion, extend the total 
time period for filing any proposed findings, conclusions, orders or 
briefs for an additional 30 days. In such instances, briefs and replies 
shall be due at such time as the Administrative Law Judge may fix by 
order. The hearing shall be deemed closed at the conclusion of the 
briefing period.
    (b) Initial decision. The Administrative Law Judge, within 25 days 
after the close of the hearing, shall evaluate the record before him, 
and prepare and file his initial decision with the hearing clerk. A copy 
of the initial decision shall be served upon each of the parties, and 
the hearing clerk shall immediately transmit a copy to the Environmental 
Appeals Board. The initial decision shall become the decision of the 
Environmental Appeals Board without further proceedings unless an appeal 
is taken from it or the Environmental Appeals Board orders review of it, 
pursuant to Sec. 164.101.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.91  Accelerated decision.

    (a) General. The Administrative Law Judge, in his discretion, may at 
any time render an accelerated decision in favor of Respondent as to all 
or any portion of the proceeding, including dismissal without further 
hearing or upon such limited additional evidence such as affidavits as 
he may receive, under any of the following conditions:
    (1) Untimely or insufficient objections filed pursuant to 
Sec. 164.20;
    (2) Failure to comply with discovery orders;
    (3) Failure to comply with prehearing orders;
    (4) Failure to appear or to proceed at prehearing conferences;
    (5) Failure to appear at the hearing;
    (6) Failure to state a claim upon which relief can be granted, or 
direct or collateral estoppel.
    (7) Theat there is no genuine issue of any material fact and that 
the respondent is entitled to judgment as a matter of law; or
    (8) Such other and further reasons as are just.
    (b) Effect. A decision rendered under this section shall have the 
same force and effect as an initial decision entered under Sec. 164.90.

                                 Appeals



Sec. 164.100  Appeals from or review of interlocutory orders or rulings.

    Except as provided herein, appeals as a matter of right shall lie to 
the Environmental Appeals Board only from an initial or accelerated 
decision of the Administrative Law Judge. Appeals from other orders or 
rulings shall, except as provided in this section, lie only if the 
Administrative Law Judge certifies such orders or rulings for appeal, or 
otherwise as provided. The Administrative Law Judge may certify an order 
or ruling for appeal to the Environmental Appeals Board when: (a) The 
order or ruling involves an important question of law or policy about 
which there is substantial ground for difference of opinion; and (b) 
either (1) an immediate appeal from the order and ruling will materially 
advance the ultimate termination of the proceeding or (2) review after 
the final judgment is issued will be inadequate or ineffective. The 
Administrative Law Judge shall certify orders or rulings for appeal only 
upon the request of a party. If the Environmental Appeals Board 
determines that certification was improvidently

[[Page 174]]

granted, or takes no action within thirty (30) days of the 
certification, the appeal shall be deemed dismissed. When an order or 
ruling is not certified by the Administrative Law Judge, it shall be 
reviewed by the Environmental Appeals Board only upon appeal from the 
initial or accelerated decision except when the Environmental Appeals 
Board determines, upon request of a party and in exceptional 
circumstances, that delaying review would be deleterious to vital public 
or private interests. Except in extraordinary circumstances proceedings 
will not be stayed pending an interlocutory appeal; where a stay is 
granted, a stay of more than 30 days must be approved by the 
Environmental Appeals Board. Ordinarily, the interlocutory appeal will 
be decided on the basis of the submission made to the Administrative Law 
Judge, but the Environmental Appeals Board may allow further briefs and 
oral argument.

[57 FR 5343, Feb. 13, 1992]



Sec. 164.101  Appeals from or review of initial decisions.

    (a) Exceptions and request for oral argument. (1) Within 20 days 
after the filing of the Administrative Law Judge's initial decision, 
each party may take exception to any matter set forth in such decision 
or to any adverse order or ruling to which he objected during the 
hearing and may appeal such exceptions to the Environmental Appeals 
Board for decision by filing them in writing with the hearing clerk, 
including a section containing proposed findings of fact, conclusions, 
orders, or rulings. Within the same period of time each party filing 
exceptions and amicus curiae shall file with the hearing clerk a brief 
concerning each of the exceptions being appealed. The party shall 
include, in its brief, page references to the relevant portions of the 
record and to the Administrative Law Judge's initial decision.
    (2) Within 7 days of the service of exceptions, and of a brief under 
paragraph (a)(1) of this section, any other party or amicus curiae may 
file and serve a brief responding to exceptions or arguments raised by 
any other party. Such brief shall include references to the relevant 
portions of the record. Such brief shall not, however, raise additional 
exceptions.
    (3) Five copies of all material filed under this section shall be 
filed with the hearing clerk.
    (b) Review by Administrator when no exceptions are filed. If no 
exceptions are filed within the time provided, the hearing clerk shall 
notify the Administrator 30 days from the date of filing of the 
Administrative Law Judge's initial decision. Within 10 days after said 
notification, the Environmental Appeals Board shall issue an order 
either declining review of the initial decision or expressing its intent 
to review said initial decision. Such order may include a statement of 
issues to be briefed by the parties and a time schedule concerning 
service and filing of briefs adequate to allow the Environmental Appeals 
Board to issue a final order within 90 days from the close of the 
hearing.
    (c) Argument before the Environmental Appeals Board. (1) A party, if 
he files exceptions and a brief, shall state in writing whether he 
desires to make an oral argument thereon before the Environmental 
Appeals Board; otherwise, he shall be deemed to have waived such oral 
argument. The Environmental Appeals Board shall, however, on its own 
initiative, have the right to set an appeal for oral argument.
    (2) If the Environmental Appeals Board determines that additional 
exceptions should be argued, counsel for the parties shall be given 
reasonable written notice of such determination so as to permit 
preparation of adequate argument on all of the exceptions to be argued.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.102  Appeals from accelerated decisions.

    (a) Within 20 days after filing of an accelerated decision by the 
Administrative Law Judge, any party may file exceptions and a supporting 
brief with the hearing clerk, stating with particularity the grounds 
upon which he asserts that the decision is incorrect. The party shall 
include in its brief page references to the relevant portions of the 
record, if applicable.
    (b) Within 7 days of the service of exceptions and brief under 
paragraph (a)

[[Page 175]]

of this section, any other party or amicus curiae may file and serve a 
brief responding thereto, with appropriate page references to the 
relevant portions of the record, if applicable.
    (c) Ordinarily, the appeal from an accelerated decision will be 
decided on the basis of the submission of briefs, but the Environmental 
Appeals Board may allow additional briefs and oral argument.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.103  Final decision or order on appeal or review.

    Within 90 days after the close of the hearing or within 90 days from 
the filing of an accelerated decision, unless otherwise stipulated by 
the parties, the Environmental Appeals Board shall, on appeal or review 
from an initial or accelerated order of the Administrative Law Judge, 
issue its final decision and order, including its rulings on any 
exceptions filed by the parties; such final order may accept or reject 
all or part of the initial or accelerated decision of the Administrative 
Law Judge even if acceptable to the parties.

[57 FR 5343, Feb. 13, 1992]



Sec. 164.110  Motion for reopening hearings; for rehearing; for reargument of any proceeding; or for reconsideration of order.

    (a) Filing; service. A motion for reopening the hearing to take 
further evidence, or for rehearing or reargument of any proceeding or 
for reconsideration of the order, must be made by motion to the 
Environmental Appeals Board filed with the hearing clerk. Every such 
motion must state specifically the grounds relied upon.
    (b) Motion to reopen hearings. A motion to reopen a hearing to take 
further evidence may be filed at any time prior to the issuance of the 
Administrator's final order. Every such motion shall state briefly the 
nature and purpose of the evidence to be adduced, shall show that such 
evidence is not merely cumulative, and shall set forth good reason why 
such evidence was not adduced at a hearing.
    (c) Motions to rehear or reargue proceedings, or to reconsider final 
orders. A motion to rehear or reargue the proceeding or to reconsider 
the final order shall be filed within 10 days after the date of service 
of the final order. Every such motion must state specifically the 
matters claimed to have been erroneously decided, and alleged errors 
must be briefly stated. Motions to rehear or reargue proceedings or to 
reconsider final orders shall be directed to, and heard by, the 
Environmental Appeals Board. Motions under this section directed to the 
Administrator will not be considered, except in cases that the 
Environmental Appeals Board has referred to the Administrator pursuant 
to Sec. 164.2(g) and in which the Administrator has issued the final 
order. A motion for reconsideration shall not stay the effective date of 
the final order unless specifically so ordered by the Environmental 
Appeals Board.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992]



Sec. 164.111  Procedure for disposition of motions.

    Within 7 days following the service of any motion provided for in 
Sec. 164.110, any other party to the proceeding may file with the 
hearing clerk an answer thereto. As soon as practicable thereafter, the 
Environmental Appeals Board shall announce its decision whether to grant 
or to deny the motion. Unless the Environmental Appeals Board shall 
determine otherwise, operation of the order shall not be stayed pending 
the decision to grant or to deny the motion. In the event that any such 
motion is granted by the Environmental Appeals Board, the applicable 
rules of practice, as set out elsewhere herein, shall be followed.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



       Subpart C--General Rules of Practice for Expedited Hearings



Sec. 164.120  Notification.

    (a) Whenever the Administrator determines that action is necessary 
to prevent an imminent hazard during the time required for cancellation 
or change in classification proceedings, but that the hazard does not 
constitute

[[Page 176]]

an emergency, he shall notify the registrant of his intention to suspend 
registration of the pesticide at issue.
    (b) Such notice shall include findings pertaining to the question of 
imminent hazard and shall either be personally served on the registrant 
or be sent to the registrant by registered or certified mail, return 
receipt requested, and filed with the hearing clerk.



Sec. 164.121  Expedited hearing.

    (a) Request. (1) An expedited hearing shall be held whenever the 
Administrator has received from the registrant a timely request for such 
hearing in response to the Administrator's notice of intention to 
suspend.
    (2) A request for an expedited hearing is timely if made in writing 
or by telegram and filed with the office of the hearing clerk within 5 
days of the registrant's receipt of the notice of intention to suspend.
    (3) At the time of filing a request for an expedited hearing, the 
registrant shall also file a document setting forth objections to the 
Administrator's notice of intention to suspend and its findings 
pertaining to the question of imminent hazard. Such objections shall 
conform to the requirements of Sec. 164.21.
    (b) Presiding officer. (1) An expedited hearing shall be conducted 
by a presiding officer appointed by the Administrator, and such officer 
need not be an Administrative Law Judge.
    (2) The presiding officer shall not have the authority to make an 
initial decision on the merits but shall make a recommended decision 
only.
    (c) The issue. The expedited hearing shall address only the issue of 
whether an imminent hazard exists.
    (d) Time of hearing. The hearing shall commence within 5 days after 
the filing of the request with the office of the hearing clerk unless 
the registrant and respondent agree that it shall commence at a later 
time. As soon as possible, the presiding officer shall publish in the 
Federal Register notice of such hearing.
    (e) Intervention. Any person adversely affected by the 
Administrator's notice may move to intervene within 5 days after the 
receipt by the registrant of said notice or at any time prior to the 
conclusion of the presentation of the evidence, upon good cause found, 
except
    (1) Leave to intervene will be granted only if the motion to 
intervene meets the standards of Sec. 164.31 and, in addition, indicates 
that the movant would raise matters or introduce evidence pertinent to 
the issue of imminent hazard which would substantially assist in its 
resolution.
    (2) A movant denied permission to intervene under this section but 
who otherwise meets the standards of Sec. 164.31 and who is adversely 
affected may file proposed findings and conclusions and briefs in 
support thereof pursuant to paragraph (j) of this section. Any person 
filing under this subsection shall be deemed to have been a party to the 
proceeding, for all purposes of its further review.
    (3) When an ``emergency order'' is issued pursuant to Sec. 164.123, 
no person other than the respondent and the registrant shall participate 
in the hearing except that any person adversely affected may file 
proposed findings and conclusions and briefs in support thereof pursuant 
to paragraph (j) of this section. Any person filing under this 
subsection shall be deemed to have been a party to the proceeding for 
all purposes of its further review.
    (f) Appearances and consolidation. The provisions of Secs. 164.30 
and 164.32 apply to an expedited hearing insofar as may be practicable.
    (g) Order of proceeding and burden of proof. At the hearing, the 
proponent of suspension shall have the burden of going forward to 
present an affirmative case for the suspension. However, the ultimate 
burden of persuasion shall rest with the proponent of the registration.
    (h) Evidence. The provisions of Sec. 164.81, where applicable, apply 
to an expedited hearing.
    (i) Transcripts. The presiding officer shall make provision for 
daily transcripts and otherwise comply with the provisions of 
Sec. 164.82.
    (j) Proposed findings or conclusions; recommended decision. (1) 
Within 4 days of the conclusion of the presentation of evidence, the 
parties may propose findings and conclusions to the Presiding Officer. 
Such proposed findings and

[[Page 177]]

conclusions shall be accompanied by a brief with supporting reasons.
    (2) Within 8 days of the conclusion of the presentation of evidence, 
the Presiding Officer shall submit to the parties his proposed 
recommended findings and conclusions and a statement of the reasons on 
which they are based.
    (3) Within 10 days of the conclusion of the presentation of evidence 
the Presiding Officer shall submit to the Environmental Appeals Board 
his recommended findings and conclusions, together with the record.
    (4) Within 12 days of the conclusion of the presentation of evidence 
the parties shall submit to the Environmental Appeals Board their 
objections to the Presiding Officer's recommended findings and 
conclusions and written briefs in support thereof.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Sec. 164.122  Final order and order of suspension.

    (a) Final order. Within 7 days of receipt of the record and of the 
Presiding Officer's recommended findings and conclusions, the 
Environmental Appeals Board shall issue a final decision and order. Such 
final order may accept or reject in whole or in part the recommendations 
of the Presiding Officer.
    (b) Order of suspension. No final order of suspension shall be 
issued unless the Environmental Appeals Board has issued or at the same 
time issues a notice of its intention to cancel the registration or 
change the classification of the pesticide. Such notice shall be given 
as provided in Sec. 164.8.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Sec. 164.123  Emergency order.

    (a) Whenever the Environmental Appeals Board determines that an 
emergency exists that does not permit him to hold a hearing before 
suspension, the Environmental Appeals Board may issue a suspension order 
in advance of notification to the registrant.
    (b) The Environmental Appeals Board shall immediately notify the 
registrant of the suspension order. The registrant may then request a 
hearing in accordance with Secs. 164.121 and 164.122, but the suspension 
order shall remain in effect during the hearing pending the issuance of 
a final order on suspension.

[38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992]



Subpart D--Rules of Practice for Applications Under Sections 3 and 18 To 
            Modify Previous Cancellation or Suspension Orders

    Authority: Sec. 25(a) and 6 of the Federal Insecticide, Fungicide, 
and Rodenticide Act, as amended by the Federal Environmental Pesticide 
Control Act of 1972 (86 Stat. 997).

    Source: 40 FR 12265, Mar. 18, 1975, unless otherwise noted.



Sec. 164.130  General.

    EPA has determined that any application under section 3 or section 
18 of the Act to allow use of a pesticide at a site and on a pest for 
which registration has been finally cancelled or suspended by the 
Administrator constitutes a petition for reconsideration of such order. 
Because of the extensive notice and hearing opportunities mandated by 
FIFRA and the Administrative Procedures Act before a final cancellation 
or suspension order may be issued, EPA has determined that such orders 
may not be reversed or modified without affording interested parties--
who may in fact have participated in lengthy cancellation proceedings--
similar notice and hearing opportunities. The procedures set forth in 
this subpart D shall govern all such applications.



Sec. 164.131  Review by Administrator.

    (a) The Administrator will review applications subject to this 
subpart D and supporting data submitted by the applicant to determine 
whether reconsideration of the Administrator's prior cancellation or 
suspension order is warranted. The Administrator shall determine that 
such reconsideration is warranted when he finds that: (1) The applicant 
has presented substantial new evidence which may materially affect the 
prior cancellation or suspension order and which was not available to 
the Administrator at the time he

[[Page 178]]

made his final cancellation or suspension determination and (2) such 
evidence could not, through the exercise of due diligence, have been 
discovered by the parties to the cancellation or suspension proceeding 
prior to the issuance of the final order.
    (b) If after review of the application and other supporting data 
submitted by the applicant, the Administrator determines, in accordance 
with paragraph (a) of this section, that reconsideration of his prior 
order is not warranted, then the application will be denied without 
requirement for an administrative hearing. The Administrator shall 
publish notice in the Federal Register of the denial briefly describing 
the basis for his determination as soon as practicable. Such denial 
shall constitute final agency action.
    (c) If after review of the application and other supporting data 
submitted by the applicant, the Administrator determines, in accordance 
with paragraph (a) of this section, that reconsideration of his prior 
order is warranted, he will then publish notice in the Federal Register 
setting forth his determination and briefly describing the basis for the 
determination. Such notice shall announce that a formal public hearing 
will be held in accordance with 5 U.S.C. section 554. The notice shall 
specify: (1) The date on which the hearing will begin and end, (2) the 
issues of fact and law to be adjudicated at the hearing, (3) the date on 
which the presiding officer shall submit his recommendations, including 
findings of fact and conclusions, to the Administrator, and (4) the date 
on which a decision by the Administrator is anticipated.



Sec. 164.132  Procedures governing hearing.

    (a) The burden of proof in the hearing convened pursuant to 
Sec. 164.131 shall be on the applicant and he shall proceed first. The 
issues in the hearing shall be whether: (1) Substantial new evidence 
exists and (2) such substantial new evidence requires reversal or 
modification of the existing cancellation or suspension order. The 
determination of these issues shall be made taking into account the 
human and environmental risks found by the Administrator in his 
cancellation or suspension determination and the cumulative effect of 
all past and present uses, including the requested use, and uses which 
may reasonably be anticipated to occur in the future as a result of 
granting the requested reversal or modification. The granting of a 
particular petition for use may not in itself pose a significant risk to 
man or the environment, but the cumulative impact of each additional use 
of the cancelled or suspended pesticide may re-establish, or serve to 
maintain, the significant risks previously found by the Administrator.
    (b) The presiding officer shall make recommendations, including 
findings of fact and conclusions and to the extent feasible, as 
determined by the presiding officer, the procedures at the hearing shall 
follow the Rules of Practice, set forth in subparts A and B of this part 
164.



Sec. 164.133  Emergency waiver of hearing.

    (a) In the case of an application subject to this subpart D which is 
filed under section 18 of FIFRA, and regulations thereunder, and for 
which a hearing is required pursuant to Sec. 164.131, the Administrator 
may dispense with the requirement of convening such a hearing in any 
case in which he determines:
    (1) That the application presents a situation involving need to use 
the pesticide to prevent an unacceptable risk: (i) To human health, or 
(ii) to fish or wildlife populations when such use would not pose a 
human health hazard; and
    (2) That there is no other feasible solution to such risk; and
    (3) That the time available to avert the risk to human health or 
fish and wildlife is insufficient to permit convening a hearing as 
required by Sec. 164.131; and
    (4) That the public interest requires the granting of the requested 
use as soon as possible.
    (b) Notice of any determination made by the Administrator pursuant 
to paragraph (a) of this section shall be published in the Federal 
Register as soon as practicable after granting the requested use and 
shall set forth the basis for the Administrator's determination.

[[Page 179]]



PART 166--EXEMPTION OF FEDERAL AND STATE AGENCIES FOR USE OF PESTICIDES UNDER EMERGENCY CONDITIONS--Table of Contents




                      Subpart A--General Provisions

Sec.
166.1  Purpose and organization.
166.2  Types of exemptions.
166.3  Definitions.
166.7  User notification; advertising.

      Subpart B--Specific, Quarantine, and Public Health Exemptions

166.20  Application for a specific, quarantine, or public health 
          exemption.
166.22  Consultation with the Secretary of Agriculture and Governors of 
          the States.
166.24  Public notice of receipt of application and opportunity for 
          public comment.
166.25  Agency review.
166.28  Duration of exemption.
166.30  Notice of Agency decision.
166.32  Reporting and recordkeeping requirements for specific, 
          quarantine, and public health exemptions.
166.34  EPA review of information obtained in connection with emergency 
          exemptions.
166.35  Revocation or modification of exemptions.

                      Subpart C--Crisis Exemptions

166.40  Authorization.
166.41  Limitations.
166.43  Notice to EPA and registrants or basic manufacturers.
166.45  Duration of crisis exemption.
166.47  Notification of FDA, USDA, and State health officials.
166.49  Public notice of crisis exemptions.
166.50  Reporting and recordkeeping requirements for crisis exemption.
166.53  EPA review of crisis exemption and revocation of authority.

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

    Source: 51 FR 1902, Jan. 15, 1986, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 166.1  Purpose and organization.

    (a) Purpose and scope. Section 18 of the Act authorizes the 
Administrator to exempt State and Federal agencies from any provision of 
the Act, if he determines that emergency conditions exist which require 
an exemption. The regulations in this part establish procedures whereby 
the Administrator may exempt a Federal or State agency from the 
provisions of the Act which regulate the manner in which a pesticide is 
made available for use or is used.
    (b) Organization. (1) The provisions in subpart A of this part 
describe the four types of emergency exemptions authorized by the Agency 
and define terms used in this part.
    (2) Subpart B of this part establishes procedures and criteria for 
specific, quarantine, and public health exemptions.
    (3) Subpart C of this part establishes procedures and criteria for 
crisis exemptions.



Sec. 166.2  Types of exemptions.

    There are four types of emergency exemptions which may be 
authorized: specific, quarantine, public health, and crisis exemptions.
    (a) Specific exemption. A specific exemption may be authorized in an 
emergency condition to avert:
    (1) A significant economic loss; or
    (2) A significant risk to:
    (i) Endangered species,
    (ii) Threatened species,
    (iii) Beneficial organisms, or
    (iv) The environment.
    (b) Quarantine exemption. A quarantine exemption may be authorized 
in an emergency condition to control the introduction or spread of any 
pest new to or not theretofore known to be widely prevalent or 
distributed within and throughout the United States and its territories.
    (c) Public health exemption. A public health exemption may be 
authorized in an emergency condition to control a pest that will cause a 
significant risk to human health.
    (d) Crisis exemption. A crisis exemption may be utilized in an 
emergency condition when the time from discovery of the emergency to the 
time when the pesticide use is needed is insufficient to allow for the 
authorization of a specific, quarantine, or public health exemption.



Sec. 166.3  Definitions.

    Terms used in this part shall have the meanings established by the 
Federal Insecticide, Fungicide, and Rodenticide Act. In addition, as 
used in

[[Page 180]]

this part, the following terms shall also apply:
    (a) The term the Act means the Federal, Insecticide, Fungicide, and 
Rodenticide Act, as amended, 7 U.S.C. 136 et seq.
    (b) The terms the Agency and EPA mean the U.S. Environmental 
Protection Agency.
    (c) The term beneficial organism means any pollinating insect, or 
any pest predator, parasite, pathogen or other biological control agent 
which functions naturally or as part of an integrated pest management 
program to control another pest.
    (d) The term emergency condition means an urgent, non-routine 
situation that requires the use of a pesticide(s) and shall be deemed to 
exist when:
    (1) No effective pesticides are available under the Act that have 
labeled uses registered for control of the pest under the conditions of 
the emergency; and
    (2) No economically or environmentally feasible alternative 
practices which provide adequate control are available; and
    (3) The situation:
    (i) Involves the introduction or dissemination of a pest new to or 
not theretofore known to be widely prevalent or distributed within or 
throughout the United States and its territories; or
    (ii) Will present significant risks to human health; or
    (iii) Will present significant risks to threatened or endangered 
species, beneficial organisms, or the environment; or
    (iv) Will cause significant economic loss due to:
    (A) An outbreak or an expected outbreak of a pest; or
    (B) A change in plant growth or development caused by unusual 
environmental conditions where such change can be rectified by the use 
of a pesticide(s).
    (e) The term first food use refers to the use of a pesticide on a 
food or in a manner which otherwise would be expected to result in 
residues in a food, if no permanent tolerance, exemption from the 
requirement of a tolerance, or food additive regulation for residues of 
the pesticide on any food has been established for the pesticide under 
section 408 (d) or (e) or 409 of the Federal Food, Drug, and Cosmetic 
Act.
    (f) The term food means any article used for food or drink for man 
or animals.
    (g) The term new chemical means an active ingredient not contained 
in any currently registered pesticide.
    (h) The term significant economic loss means that, under the 
emergency conditions: for a productive activity, the profitability would 
be substantially below the expected profitability for that activity; or, 
for other types of activities, where profits cannot be calculated, the 
value of public or private fixed assets would be substantially below the 
expected value for those assets. Only losses caused by the emergency 
conditions, specific to the impacted site, and specific to the 
geographic area affected by the emergency conditions are included. The 
contribution of obvious mismanagement to the loss will not be considered 
in determining loss. In evaluating the significant of an economic loss 
for productive activities, the Agency will consider whether the expected 
reduction in profitability exceeds what would be expected as a result of 
normal fluctuations over a number of years, and whether the loss would 
affect the long-term financial viability expected from the productive 
activity. In evaluating the significance of an economic loss for 
situations other than productive activities, the Agency will consider 
reasonable measures of expected loss.
    (i) The term Special Review refers to any interim administrative 
review of the risks and benefits of the use of a pesticide conducted 
pursuant to the provisions of EPA's Rebuttable Presumption Against 
Registration rules, 40 CFR 162.11(a), or any subsequent version of those 
rules.
    (j) The term unreasonable adverse effects on the environment means 
any unreasonable risk to man or the environment, taking into account the 
economic, social, and environmental costs and benefits of the use of any 
pesticide.

[[Page 181]]



Sec. 166.7  User notification; advertising.

    (a) A State or Federal agency that obtains an exemption may notify 
eligible users of the availability of the exempted pesticide(s) through 
user groups, retail dealers, and other means. Notification may include 
distributing copies of the section 18 approval letter, labeling, or 
other information to eligible persons.
    (b) As set forth more fully in Sec. 168.22 of this chapter, EPA 
interprets FIFRA sections 12(a)(1) (A) and (B) as making it unlawful for 
any person who distributes, sells, offers for sale, holds for sale, 
ships, delivers for shipment, or receives and (having so received) 
delivers or offers to deliver any pesticide, to advertise the pesticide 
for any use authorized by an emergency exemption, except for 
advertisements that are placed in media that address only persons in the 
geographical area to which the exemption applies, state the name and 
address of one or more retail dealers where users may buy the pesticide, 
and contain a prominent notice of the limitations on use under the 
emergency exemption. EPA may withdraw an exemption if the use of the 
pesticide covered by the exemption is advertised unlawfully.

[54 FR 1125, Jan. 11, 1989]



      Subpart B--Specific, Quarantine, and Public Health Exemptions



Sec. 166.20  Application for a specific, quarantine, or public health exemption.

    (a) General information required in an application for a specific, 
quarantine or public health exemption. An application must be submitted 
in writing by the head of the Federal or State agency, the Governor of 
the State involved, or their official designee. If a designee has been 
delegated authority to request exemptions, written authorization of such 
delegation must accompany the request or be on file with the Agency. In 
addition, the application must contain all applicable information 
specified in paragraphs (a) (1) through (11) of this section.
    (1) Identity of contact persons. (i) Unless otherwise specified, the 
person who submits the application will be considered the contact person 
for all matters relating to administration of the emergency exemption.
    (ii) Requests should identify by name and telephone number one or 
more qualified experts who may be contacted in case any questions arise 
concerning the application.
    (2) Description of the pesticide. The application shall contain a 
description of the pesticide(s) proposed for use under the exemption. 
Such information shall include:
    (i) For a federally registered pesticide product:
    (A) The registration number and the name of the pesticide product if 
a specific product is requested; or the formulation(s) requested if a 
specific product is not desired; and
    (B) A copy of any additional labeling proposed for the emergency 
exemption; or
    (ii) For any other pesticide products:
    (A) A confidential statement of formula or reference to one already 
submitted to the Agency; and
    (B) Complete labeling to be used in connection with the proposed 
exemption use.
    (3) Description of the proposed use. The application shall identify 
all of the following:
    (i) Sites to be treated, including their locations within the State;
    (ii) The method of application;
    (iii) The rate of application in terms of active ingredient and 
product;
    (iv) The total acreage or other appropriate unit proposed to be 
treated;
    (v) The total amount of pesticide proposed to be used in terms of 
both active ingredient and product; and
    (vi) All applicable restrictions and requirements concerning the 
proposed use and the qualifications of applicators using the pesticide.
    (4) Alternative methods of control. The application shall contain:
    (i) A detailed explanation of why the pesticide(s) currently 
registered for the particular use proposed in the application is not 
available in adequate supplies and/or effective to the degree needed to 
control the emergency. If the applicant states that an available 
registered pesticide is ineffective for the given situation, the 
statement must be

[[Page 182]]

supported by field data which demonstrate ineffectiveness of registered 
pesticides, or, if such data are unavailable, statements by qualified 
agricultural experts, extension personnel, university personnel or other 
persons similarly qualified in the field of pest control; and
    (ii) A detailed explanation of why alternative practices, if 
available, either would not provide adequate control or would not be 
economically or environmentally feasible.
    (5) Effectiveness of proposed use. The application shall contain 
data, a discussion of field trials, or other evidence which provide the 
basis for the conclusion that the proposed pesticide treatment will be 
effective in dealing with the emergency.
    (6) Discussion of residues for food uses. If the proposed use is 
expected to result in residues of the pesticide in or on food, the 
application shall list the food likely to contain such residues and 
shall contain an estimate of the maximum amount of the residue likely to 
result from the proposed use, together with the information on which 
such estimates are based.
    (7) Discussion of risk information. The application shall address 
the potential risks to human health, endangered or threatened species, 
beneficial organisms, and the environment expected to result from the 
proposed use, together with references to data and other supporting 
information.
    (8) Coordination with other affected State or Federal agencies. If 
the proposed use of the pesticide is likely to be of concern to other 
Federal or State agencies, the application shall indicate that such 
agencies have been contacted prior to submission of the application, and 
any comments received from such agencies shall be submitted to EPA.
    (9) Notification of registrant or basic manufacturer. The 
application shall contain a statement that the registrants of all 
pesticide products proposed for use or, if appropriate, the basic 
manufacturer have been notified that a request has been made to the 
Agency for use of the pesticide under a specific, quarantine, or public 
health exemption.
    (10) Description of proposed enforcement program. Prior to approval, 
the applicant shall provide an explanation of the authority of the 
applicant or related State or Federal agencies for ensuring that use of 
the pesticide under the proposed exemption would comply with any special 
requirements imposed by the Agency and a description of the program and 
procedures for assuring such compliance.
    (11) Repeated uses. Applications for the use of a pesticide at a 
site for which the applicant has previously been exempted under section 
18 shall contain an interim report summarizing the results of the 
specific, quarantine, or public health exemption previously issued, if 
the application is submitted prior to the time the final report for the 
previous exemption is due. The interim report shall contain that 
information specified in Sec. 166.32 to the extent available at the time 
the application is made.
    (b) Information required for a specific exemption. An application 
for a specific exemption shall provide all of the following information, 
as appropriate, concerning the nature of the emergency:
    (1) The scientific and common name of the pest or pest complex;
    (2) A discussion of the events which brought about the emergency 
condition;
    (3) A discussion of the anticipated risks to endangered or 
threatened species, beneficial organisms, or the environment that would 
be remedied by the proposed use of the pesticide; and
    (4) A discussion of the anticipated significant economic loss, 
together with data and other information supporting the discussion, 
which addresses all of the following:
    (i) Historical net and gross revenues for the site;
    (ii) The estimated net and gross revenues for the site without the 
use of the proposed pesticide; and
    (iii) The estimated net and gross revenues for the site with use of 
the proposed pesticide.
    (c) Information required for a quarantine exemption. An application 
for a quarantine exemption shall provide all of the following 
information concerning the nature of the emergency:
    (1) The scientific and common name of pest;

[[Page 183]]

    (2) The origin of pest and the means of its introduction or spread 
if known; and
    (3) The anticipated impact of not controlling the pest.
    (d) Information required for a public health exemption. An 
application for a public health exemption shall provide all the 
following information concerning the nature of the emergency:
    (1) The scientific and common name of the pest to be controlled and, 
if the pest is a vector, a description of the disease it is expected to 
transmit;
    (2) A discussion of the magnitude of the health problems which are 
expected to occur without the pesticide use; and
    (3) Discussion of the availability of medical treatment for the 
health problem.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]



Sec. 166.22  Consultation with the Secretary of Agriculture and Governors of the States.

    The Agency, in determining whether or not such emergency conditions 
exist, shall consult with the Secretary of Agriculture and the Governor 
of any State concerned if they request such determination.



Sec. 166.24  Public notice of receipt of application and opportunity for public comment.

    (a) Publication requirement. The Administrator shall issue a notice 
of receipt in the Federal Register for a specific quarantine, or public 
health exemption and request public comment when any one of the 
following criteria is met:
    (1) The application proposes use of a new chemical;
    (2) The application proposes the first food use of an active 
ingredient;
    (3) The application proposes any use of a pesticide if the pesticide 
has been subject to a suspension notice under section 6(c) of the Act;
    (4) The application proposes use of a pesticide which:
    (i) Was the subject of a notice under section 6(b) of the Act and 
was subsequently cancelled, and
    (ii) Is intended for a use that poses a risk similar to the risk 
posed by any use of the pesticide which was the subject of the notice 
under section 6(b);
    (5) The application proposes use of a pesticide which:
    (i) Contains an active ingredient which is or has been the subject 
of a Special Review, and
    (ii) Is intended for a use that could pose a risk similar to the 
risk posed by any use of the pesticide which is or has been the subject 
of the Special Review;
    (6) The application proposes use of a pesticide for a specific or 
public health exemption, if:
    (i) An emergency exemption has been requested or granted for that 
use in any 3 previous years, and
    (ii) A complete application for registration of that use and/or a 
petition for tolerance for residues in or on the commodity has not been 
submitted to the Agency; or
    (7) The Administrator determines that publication of notice is 
appropriate.
    (b) Contents. The notice of receipt of an application for an 
emergency exemption shall contain the following information:
    (1) The name of the applicant;
    (2) The name of the active ingredient requested for use, including, 
if available, the common name and the Chemical Abstracts Service (CAS) 
number;
    (3) The total amount of product or active ingredient proposed for 
use;
    (4) The geographical location where treatment is proposed;
    (5) The proposed number of acres or other appropriate units proposed 
to be treated;
    (6) A summary of the applicant's description of the emergency 
conditions including the pest and the site or crop to be treated;
    (7) A description of the major conditions of use of the pesticide as 
proposed by the applicant;
    (8) If the pesticide proposed for use meets the criteria of 
paragraph (a) (3), (4), or (5) of this section, an identification of the 
types of risks that were the basis for EPA's regulatory action; and
    (9) The name, telephone number, and address of a person in the 
Agency who can provide further information.
    (c) Length of comment period. Normally, a notice of receipt shall 
give the

[[Page 184]]

public 15 days in which to file comments on the application. The 
Administrator may shorten or eliminate the comment period if he 
determines that the time available for a decision on the application 
requires it and shall state reasons for such action in a notice in the 
Federal Register. The Administrator may extend the comment period if 
additional time for comment is requested and such an extension would not 
interfere with a timely decision on the application.



Sec. 166.25  Agency review.

    (a) General. The Agency will review all requests as expeditiously as 
possible, making every attempt to respond to requests prior to the time 
when the proposed use is needed. The Agency will review the application 
and other available data necessary to make a determination with respect 
to all of the following:
    (1) Whether an emergency condition exists or will exist;
    (2) The level of residues in or on all food resulting from the 
proposed use;
    (3) The anticipated benefits to be derived from the proposed use; 
and
    (4) The potential risks to the human health, endangered or 
threatened species, beneficial organisms, and the environment from the 
proposed use.
    (b) Criteria for approval. The Administrator may authorize a 
specific, public health, or quarantine exemption, based on the 
information available to the Agency, after:
    (1) He determines that:
    (i) An emergency condition exists;
    (ii) The use of the pesticide under the exemption will not cause 
unreasonable adverse effects on the environment;
    (iii) Registration of the pesticide use for which the exemption is 
requested has not been suspended under section 6(c) of the Act or 
cancelled following a notice under section 6(b) of the Act, unless the 
use is authorized in accordance with the provisions of Secs. 164.130 
through 164.133 of this chapter;
    (2) Giving due consideration to:
    (i) Whether the pesticide is reasonably likely to be used in 
compliance with the requirements imposed by the Agency under the 
exemption; and
    (ii) The progress which has been made toward registration of the 
proposed use, if a repeated specific or public health exemption is 
sought. It shall be presumed that if a complete application for 
registration of a use, which has been under a specific or public health 
exemption for any 3 previous years, has not been submitted, reasonable 
progress towards registration has not been made.



Sec. 166.28  Duration of exemption.

    (a) Specific or public health exemptions. EPA shall allow use of a 
pesticide under a specific or public health exemption for as long a 
period as is reasonably expected to be necessary but in no case for 
longer than 1 year.
    (b) Quarantine exemption. EPA shall allow use of a pesticide under a 
quarantine exemption for as long a period as is deemed necessary but in 
no case for longer than 3 years. Quarantine exemptions may be renewed. 
Interim reports containing the information specified in Sec. 166.32(b) 
to the extent available shall be filed annually.



Sec. 166.30  Notice of Agency decision.

    (a) Notification of applicants. The Agency shall notify an applicant 
of its decision to approve or deny an application request for an 
emergency exemption in a timely manner.
    (1) Incomplete applications. The Agency may discontinue the 
processing of any application which does not contain all of the 
information required by Sec. 166.20 until such time the additional 
information is submitted by the applicant.
    (2) Complete applications--(i) Denials. The Agency shall provide the 
specific reasons and rationale for denying the exemption request. If the 
denial is based on a specific information gap, the decision shall be 
reconsidered in a timely manner when the information gap is filled.
    (ii) Approvals. The Agency shall provide the specific terms and 
conditions under which the exempted pesticide may be used.
    (b) Notification of FDA, USDA, and State health officials. If a use 
authorized under a specific, quarantine, or public health exemption will 
result in residues of the pesticide chemical in or on food, the Agency 
shall notify the Food

[[Page 185]]

and Drug Administration, U.S. Department of Health and Human Services, 
and the Food Safety and Inspection Service, U.S. Department of 
Agriculture, as appropriate, of the level of residues expected to 
result. Additionally, the Agency shall ensure that State health and food 
officials, as appropriate, are also provided with the information 
specified in this paragraph.
    (c) Federal Register publication. (1) At least quarterly, the 
Administrator shall issue a notice in the Federal Register announcing 
all approvals of specific, quarantine, and public health exemptions. The 
notice shall contain all of the following:
    (i) The name of the applicant;
    (ii) The pesticide authorized for use;
    (iii) The crop or site to be treated; and
    (iv) The name, address, and telephone number of a person in the 
Agency who can provide further information.
    (2) In addition, if EPA has issued a Notice of Receipt of an 
application for an exemption, it will issue a notice of its final 
decision and the reasons for that decision.



Sec. 166.32  Reporting and recordkeeping requirements for specific, quarantine, and public health exemptions.

    (a) Unexpected adverse effects information. Any unexpected adverse 
effects resulting from the use of a pesticide under a specific, 
quarantine, or public health exemption must be immediately reported to 
the Agency.
    (b) Final reports. A report summarizing the results of pesticide use 
under a specific, quarantine, and public health exemption must be 
submitted to the Agency within 6 months from the expiration of the 
exemption unless otherwise specified by the Agency. The information in 
this report shall include all of the following:
    (1) Total acreage, amount of commodity or other unit treated and the 
total quantity of the pesticide used;
    (2) A discussion of the effectiveness of the pesticide in dealing 
with the emergency condition;
    (3) A description of any unexpected adverse effects which resulted 
from use of the pesticide under the exemption;
    (4) The results of any monitoring required and/or carried out under 
the exemption;
    (5) A discussion of any enforcement actions taken in connection with 
the exemption;
    (6) Method(s) of disposition of a food crop, if required to be 
destroyed under an exemption; and
    (7) Any other information requested by the Administrator.
    (c) Records. Records for all treatments involving the first food use 
of a pesticide will be maintained by the agency to which the emergency 
exemption was granted for a minimum of 2 years following the date of 
expiration of the exemption. On request by the Agency these records 
shall be made available to the Administrator. Records will include all 
of the following:
    (1) Locations where the pesticide was applied;
    (2) Dates of application (range); and
    (3) Total quantity of the pesticide used.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]



Sec. 166.34  EPA review of information obtained in connection with emergency exemptions.

    EPA shall review information submitted in connection with emergency 
exemptions and, when applicable, use it in connection with other 
regulatory decisions under the Act.



Sec. 166.35  Revocation or modification of exemptions.

    (a) Grounds. The Administrator may revoke or modify the terms or 
conditions of a specific, quarantine, or public health exemption if he 
determines one of the following:
    (1) An emergency no longer exists;
    (2) Use of the pesticide under the exemption may cause unreasonable 
adverse effects on the environment;
    (3) The pesticide authorized under the exemption is not effective at 
controlling the pest or conditions causing the emergency; or
    (4) The terms and conditions established by the exemption and these 
regulations are not being complied with.
    (b) Implementation. The revocation or modification becomes effective 
as soon

[[Page 186]]

as the Administrator notifies the State or Federal agency which 
submitted the application. Upon notification, the applicant is required 
immediately to take all necessary steps to assure that further use 
complies with the terms and conditions of any modification or, if the 
exemption has been revoked, to stop further use.



                      Subpart C--Crisis Exemptions



Sec. 166.40  Authorization.

    The head of a Federal or State agency, the Governor of a State, or 
their official designee, may issue a crisis exemption in situations 
involving an unpredictable emergency situation when:
    (a) An emergency condition exists; and
    (b) The time element with respect to the application of the 
pesticide is critical, and there is not sufficient time either to 
request a specific, quarantine, or public health exemption or, if such a 
request has been submitted, for EPA to complete review of the request.



Sec. 166.41  Limitations.

    The crisis provisions may not be utilized to authorize a pesticide 
use if any of the following has occurred:
    (a) EPA has informed the head of the Federal or State agency, the 
Governor, or their official designee, not to issue such an exemption;
    (b) The pesticide use has been suspended under section 6(c) of the 
Act;
    (c) The pesticide use has been cancelled following a notice issued 
under section 6(b) of the Act;
    (d) The pesticide contains a new chemical; or
    (e) The application proposes the first food use of a pesticide.



Sec. 166.43  Notice to EPA and registrants or basic manufacturers.

    (a) Timing of notice. (1) When feasible, the State or Federal Agency 
issuing the crisis exemption must notify the Administrator at least 36 
hours in advance of utilization of the crisis provisions. In no case 
shall notice be given to the Agency later than 24 hours after the 
decision to avail itself of a crisis exemption.
    (2) The State or Federal agency issuing the crisis exemption shall 
notify the registrant(s) or, if appropriate, the basic manufacturer(s) 
of the pesticide(s) being used under the crisis exemption at the same 
time notice is given to EPA or as soon thereafter as possible.
    (b) Contents of notice. Information required to be provided in 
notices shall include all of the following:
    (1) The name of the active ingredient authorized for use, including, 
if available, the common name and the Chemical Abstracts Service (CAS) 
number;
    (2) The site on which the pesticide is to be used or is being used;
    (3) The use pattern;
    (4) The date on which the pesticide use is to begin or the date on 
which use of the pesticide began;
    (5) An estimate of the level of residues of the pesticide expected 
to result from use under the crisis exemption; and
    (6) Any other pertinent information available at the time.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]



Sec. 166.45  Duration of crisis exemption.

    A crisis exemption may be authorized for:
    (a) Only as long as is necessary to control the pest or conditions 
causing the emergency; and
    (b) No longer than 15 days, unless an application requesting a 
specific, quarantine, or public health exemption for this use has been 
submitted to the Agency.



Sec. 166.47  Notification of FDA, USDA, and State health officials.

    If a use authorized under a crisis exemption will result in residues 
of the pesticide chemical in or on food, the Agency will notify the 
authorizing agency, the Food and Drug Administration, U.S. Department of 
Health and Human Services and the Food Safety and Inspection Service, 
U.S. Department of Agriculture, as appropriate, of the level of residues 
expected to result and whether such residues pose an unacceptable risk 
to public health. This notice shall be provided as soon as the Agency 
makes its determination. Additionally, the Agency will ensure that

[[Page 187]]

State health and food officials, as appropriate, are also provided with 
this information.



Sec. 166.49  Public notice of crisis exemptions.

    (a) Periodic notices. At least quarterly, the Administrator shall 
issue a notice in the Federal Register announcing issuance of crisis 
exemptions. The notice shall contain all of the following:
    (1) The name of the State or Federal agency using a crisis 
exemption;
    (2) The name of the active ingredient authorized for use, including, 
if available, the common name and the Chemical Abstracts Service (CAS) 
number;
    (3) The site to be treated;
    (4) The name, telephone number, and address of a person in the 
Agency who can provide further information; and
    (5) Whether a specific, quarantine, or public health exemption has 
been requested.
    (b) Annual reports. Annually, the Agency shall issue a notice in the 
Federal Register that shall summarize:
    (1) The number of crisis exemptions declared; and
    (2) The number of crisis exemptions revoked.



Sec. 166.50  Reporting and recordkeeping requirements for crisis exemption.

    (a) Adverse effects information. Any adverse effects resulting from 
the use of a pesticide under a crisis exemption must be immediately 
reported to the Agency.
    (b) Final reports. (1) A report summarizing the results of treatment 
under a crisis exemption will be required to be submitted to the Agency 
within 3 months following the last date of treatment. If a specific, 
quarantine, or public health exemption has been approved while the 
crisis exemption is in effect, however, the crisis exemption report may 
be incorporated into the specific, quarantine, or public health 
exemption final report required under Sec. 166.32(b) and submitted at 
the time it is due.
    (2) Information to be included in the crisis exemption report 
includes the same information as required in Sec. 166.32(b) and an 
explanation as to why there was a need to utilize the crisis provisions.
    (c) Records. Records will be maintained for a minimum of 2 years 
following the date of expiration of the exemption. On request by the 
Agency, these records shall be made available to the Administrator. 
Records will include all of the following:
    (1) Location where the pesticide was applied;
    (2) Dates of application (range); and
    (3) Total quantity of the pesticide used.

[51 FR 1902, Jan. 15, 1986, as amended at 58 FR 34203, June 23, 1993]



Sec. 166.53  EPA review of crisis exemption and revocation of authority.

    (a) Review. When a crisis exemption is about to be or has already 
been declared by a State or Federal agency, EPA will undertake an 
expedited review of the pesticide to determine if use of the pesticide 
may result in such unreasonable health or environmental risks that the 
crisis authority should not be exercised or the crisis exemption should 
be revoked.
    (b) Revocation--(1) Individual crisis exemptions. A crisis exemption 
for the use of a specific pesticide may be revoked if the Administrator 
determines that:
    (i) There are insufficient data to determine the risks posed from 
the use;
    (ii) Such action is necessary to protect man or the environment; or
    (iii) The State or Federal agency is not complying with the 
requirements of this subpart C.
    (2) State or Federal agency authority. The Administrator may revoke 
the authority of a State or Federal agency to issue crisis exemptions 
for any pesticide if he determines that:
    (i) Such action is necessary to protect man or the environment; or
    (ii) The State or Federal agency is not complying with the 
requirements of this subpart C.
    (c) Reason for revocation. The Agency shall provide the specific 
reasons for revoking an agency's authority to issue a crisis exemption 
and for revoking an issued crisis exemption.

[[Page 188]]



PART 167--REGISTRATION OF PESTICIDE AND ACTIVE INGREDIENT PRODUCING ESTABLISHMENTS, SUBMISSION OF PESTICIDE REPORTS--Table of Contents




                      Subpart A--General Provisions

Sec.
167.3  Definitions.

                  Subpart B--Registration Requirements

167.20  Establishments requiring registration.

Subparts C-D [Reserved]

           Subpart E--Recordkeeping and Reporting Requirements

167.85  Reporting requirements.
167.90  Where to obtain and submit forms.

    Authority: 7 U.S.C. 136 (e) and (w).

    Source: 53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, 
unless otherwise noted.



                      Subpart A--General Provisions



Sec. 167.3  Definitions.

    Terms used in this part shall have the meanings set forth for such 
terms in the Federal Insecticide, Fungicide, and Rodenticide Act. In 
addition, when used in this part, the following terms shall have the 
meanings stated below:
    Act means the Federal Insecticide, Fungicide, and Rodenticide Act, 
as amended, 7 U.S.C. 136 et seq.
    Amount of pesticidal product means quantity, expressed in weight or 
volume of the product, and is to be reported in pounds for solid or 
semi-solid pesticides and active ingredients or gallons for liquid 
pesticides and active ingredients, or number of individual retail units 
for devices.
    Current production [sales or distribution] means amount of planned 
production in the calendar year in which the pesticides report is 
submitted, including new pesticidal products not previously sold or 
distributed.
    Custom blender means any establishment which provides the service of 
mixing pesticides to a customer's specifications, usually a 
pesticide(s)-fertilizer(s), pesticide-pesticide, or a pesticide-animal 
feed mixture, when: (1) The blend is prepared to the order of the 
customer and is not held in inventory by the blender; (2) the blend is 
to be used on the customer's property (including leased or rented 
property); (3) the pesticide(s) used in the blend bears end-use labeling 
directions which do not prohibit use of the product in such a blend; (4) 
the blend is prepared from registered pesticides; (b) the blend is 
delivered to the end-user along with a copy of the end-use labeling of 
each pesticide used in the blend and a statement specifying the 
composition of mixture; and (6) no other pesticide production activity 
is performed at the establishment.
    Device means any device or class of devices as defined by the Act 
and determined by the Administrator pursuant to section 25(c) to be 
subject to the provisions of section 7 of the Act.
    Establishment means any site where a pesticidal product, active 
ingredient, or device is produced, regardless of whether such site is 
independently owned or operated, and regardless of whether such site is 
domestic and producing a pesticidal product for export only, or whether 
the site is foreign and producing any pesticidal product for import into 
the United States.
    Past year means the calendar year immediately prior to that in which 
the report is submitted.
    Pesticidal product means a pesticide, active ingredient, or device.
    Pesticidal product report means information showing the types and 
amounts of pesticidal products which were: (1) Produced in the past 
calendar year; (2) produced in the current calendar year; and, (3) sold 
or distributed in the past calendar year. For active ingredients, the 
pesticidal product report must include information on the types and 
amounts of an active ingredient for which there is actual or 
constructive knowledge of its use or intended use as a pesticide. This 
pesticidal product report also pertains to those products produced for 
export only which must also be reported. A positive or a negative annual 
report is required in order to maintain registration for the 
establishment.
    Produce means to manufacture, prepare, propagate, compound, or 
process any pesticide, including any pesticide produced pursuant to 
section 5 of the

[[Page 189]]

Act, any active ingredient or device, or to package, repackage, label, 
relabel, or otherwise change the container of any pesticide or device.
    Producer means any person, as defined by the Act, who produces any 
pesticide, active ingredient, or device (including packaging, 
repackaging, labeling and relabeling).
    Sold or distributed means the aggregate amount of a pesticidal 
product released for shipment by the establishment in which the 
pesticidal product was produced.
    Type of pesticidal product refers to each individual product as 
identified by: the product name; EPA Registration Number (or EPA File 
Symbol, if any, for planned products, or Experimental Permit Number, if 
the pesticide is produced under an Experimental Use Permit); active 
ingredients; production type (technical, formulation, repackaging, 
etc.); and, market for which the product was produced (domestic, 
foreign, etc.). In cases where a pesticide is not registered, 
registration is not applied for, or the pesticide is not produced under 
an Experimental Use Permit, the term shall also include the chemical 
formulation.



                  Subpart B--Registration Requirements



Sec. 167.20  Establishments requiring registration.

    (a) Who must register. (1) Any establishment where a pesticidal 
product is produced must be registered with the Agency. This requirement 
does not apply to custom blenders as defined in this part.
    (2) Any establishment where a substance is produced must be 
registered with the Agency if the producer intends the substance to be 
used as an active ingredient of a pesticide, or has actual or 
constructive knowledge that the substance will be used by any person as 
an active ingredient of a pesticide.
    (3) Any domestic establishment producing a pesticidal product for 
export, or any unregistered pesticide, or any foreign establishment 
producing a pesticidal product for import into the United States must be 
registered. Also, any establishment, either foreign or domestic, which 
produces a pesticidal product for use under an Experimental Use Permit, 
FIFRA section 18 Emergency Exemption or section 24(c) Special Local 
Needs registration, must be registered.
    (b) Information required. An applicant for establishment 
registration must submit the following information:
    (1) Name and address of the company.
    (2) The type of ownership (individual, partnership, cooperative 
association, corporation, or any organized group of persons whether 
incorporated or not).
    (3) The name and address of each producing establishment for which 
registration is sought.
    (c) When to apply. An application for establishment registration 
must be submitted, and an establishment registration number must be 
assigned by the Agency, before any production may occur at an 
establishment. In the case of an establishment which has not previously 
been required to be registered and is not currently registered, the 
producer must apply for establishment registration by submitting an 
application within 180 days after the effective date of this regulation.
    (d) Assignment of establishment registration number. The Agency will 
return incomplete or inaccurately completed applications to the 
applicant. If the application is complete and accurate, the Agency will 
register the establishment and assign a registration number to the 
establishment. The establishment registration number will be entered on 
the application, and a copy of the application will be returned to the 
applicant.
    (e) Amendment. If at any time after the first report there is a 
change in the information required to be submitted under paragraph (b) 
of this section, that new information must be reported to EPA, in 
writing on letterhead stationery or on forms supplied by the Agency, 
within 30 days after such change occurs.
    (f) Duration of registration. Establishment registration will remain 
effective provided pesticide reports are submitted annually pursuant to 
the requirements of this part. Failure to submit a report may result in 
termination

[[Page 190]]

of establishment registration, civil and/or criminal penalty 
assessments.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 
FR 34203, June 23, 1993]

Subparts C-D [Reserved]



           Subpart E--Recordkeeping and Reporting Requirements



Sec. 167.85  Reporting requirements.

    (a) Who must report. Each producer operating an establishment must 
submit the reports required by this section concerning any pesticide, 
active ingredient, or device produced at each establishment. Custom 
blenders are not required to report production to the Agency.
    (b) Information required. The pesticide report shall include the 
following: (1) Name and address of the establishment; (2) amount of each 
pesticidal product: (i) Produced during the past year; (ii) sold or 
distributed during the past year; (iii) estimated to be produced during 
the current year. The report shall only include those pesticidal 
products actually produced at the reporting establishment. Reports 
submitted by foreign-producing establishments shall cover only those 
pesticidal products exported to the United States.
    (c) How to report. The reports required by this section must be made 
on forms supplied by the Agency. It is the ultimate responsibility of 
companies to obtain, complete, and submit the form each year.
    (d) When to report. A producer operating an establishment must 
submit an initial report no later than 30 days after the first 
registration of each establishment the producer operates. Thereafter, 
the producer must submit an annual report on or before March 1 of each 
year, even if the producer has produced no pesticidal product for that 
reporting year.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 58 
FR 34203, June 23, 1993]



Sec. 167.90  Where to obtain and submit forms.

    (a) Where to obtain forms. Any person may obtain blank forms for the 
applications and reports required by this part from any EPA Regional 
Office, or from the address listed in paragraph (b) of this section.
    (b) Where to submit applications and reports. Each producer 
operating an establishment, with the exception of those establishments 
not found at the same location as their company headquarters, must 
submit applications and reports required by this part to the EPA 
Regional Office which serves the area where the establishment is 
located. The list of Regional Office addresses is found in 40 CFR 1.7. 
Applications and reports for those establishments not found at the same 
location as their company headquarters to be submitted by the company 
headquarters to the Regional Office having jurisdiction over the State 
in which the company headquarters is located. A foreign producer who 
exports any pesticide product, device, or active ingredient to the 
United States must submit all applications and reports to:

U.S. Environmental Protection Agency, Office of Enforcement and 
Compliance Assurance, Office of Compliance, Agriculture and Ecosystems 
Division (2225A), Ariel Rios Building, 1200 Pennsylvania Avenue, N.W., 
Washington, DC 20460, ATTN: FIFRA Foreign Establishment Registration 
Contact.

[53 FR 35058, Sept. 8, 1988; 54 FR 32638, Aug. 9, 1989, as amended at 62 
FR 49620, Sept. 23, 1997; 65 FR 4577, Jan. 31, 2000]



PART 168--STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS--Table of Contents




Subpart A--General Provisions [Reserved]

                         Subpart B--Advertising

Sec.
168.22  Advertising of unregistered pesticides, unregistered uses of 
          registered pesticides and FIFRA section 24(c) registrations.

Subpart C [Reserved]

   Subpart D--Export Policy and Procedures for Exporting Unregistered 
                               Pesticides

168.65  Pesticide export label and labeling requirements.

[[Page 191]]

168.75  Procedures for exporting unregistered pesticides--purchaser 
          acknowledgement statements.
168.85  Other export requirements.

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

    Source: 54 FR 1125, Jan. 11, 1989.

Subpart A--General Provisions [Reserved]



                         Subpart B--Advertising



Sec. 168.22  Advertising of unregistered pesticides, unregistered uses of registered pesticides and FIFRA section 24(c) registrations.

    (a) FIFRA sections 12(a)(1) (A) and (B) make it unlawful for any 
person to ``offer for sale'' any pesticide if it is unregistered, or if 
claims made for it as part of its distribution or sale differ 
substantially from any claim made for it as part of the statement 
required in connection with its registration under FIFRA section 3. EPA 
interprets these provisions as extending to advertisements in any 
advertising medium to which pesticide users or the general public have 
access.
    (b) EPA regards it as unlawful for any person who distributes, 
sells, offers for sale, holds for sale, ships, delivers for shipment, or 
receives and (having so received) delivers or offers to deliver any 
pesticide, to place or sponsor advertisements which recommend or suggest 
the purchase or use of:
    (1) Any pesticide for a use authorized under a FIFRA section 5 
experimental use permit (EUP).
    (2) Any pesticide for a use authorized under a FIFRA section 18 
emergency exemption, except for advertisements that:
    (i) Are placed in media which address primarily persons in the 
geographical area to which the exemption applies.
    (ii) State the name and address of one or more retail dealers who 
stock the pesticide.
    (iii) Contain a prominent notice of the limitations on use under the 
section 18 emergency exemption.
    (3) Any pesticide for any use authorized only by a FIFRA section 
24(c) special local need registration, unless the advertisement contains 
a prominent notice of the limitations on use under the section 24(c) 
registrations.
    (4) Any unregistered pesticide for any use unless the advertisement 
is one permitted by paragraph (b) (2) or (3) of this section.
    (5) A registered pesticide product for an unregistered use, unless 
the advertisement is one permitted by paragraph (b) (2) or (3) of this 
section. However, as a matter of policy, the Agency will not regard as 
unlawful the advertisement of uses permitted by FIFRA section 2(ee) 
provided the product is not an antimicrobial pesticide targeted against 
human pathogens (see 51 FR 19174; May 28, 1986).
    (c) For purposes of paragraph (b) of this section, a ``prominent 
notice of the limitations on use'' is one which sets forth the 
limitations on use in a manner reasonably likely to be understood by 
persons to whom the advertisement is addressed. For printed advertising, 
this criterion will be met by a legend in 6-point or larger type.

Subpart C [Reserved]



   Subpart D--Export Policy and Procedures for Exporting Unregistered 
                               Pesticides

    Source: 58 FR 9085, Feb. 18, 1993, unless otherwise noted.



Sec. 168.65  Pesticide export label and labeling requirements.

    (a) General. This section describes how EPA interprets and will 
enforce the requirements of FIFRA section 17(a)(1). Every exported 
pesticide, device, and active ingredient used in producing a pesticide 
(see Sec. 152.3 of this chapter for the definition of ``active 
ingredient'' and ``pesticide'') must bear a label or labeling which 
meets the requirements of FIFRA section 17(a)(1). This requirement 
applies to all such pesticides, devices, or active ingredients, 
regardless of whether the export is for commercial or research use. In 
the case of unregistered pesticides, including research substances which 
are being exported for testing, the labeling requirements of this 
section continue to apply independently of whether the exporter must 
submit a purchaser acknowledgement statement under FIFRA section 
17(a)(2) as described at

[[Page 192]]

Sec. 168.75 of this chapter. In addition, information which will satisfy 
FIFRA section 2(q)(1)(E), (G), and (H) and section 2(q)(2)(A) and (D) 
must appear in English and in the appropriate foreign languages, on the 
label or labeling as described in paragraph (b)(4) of this section. The 
required label and labeling statements may be met through either 
immediate container labels, accompanying supplemental labeling as 
described in paragraph (c) of this section, or a combination of the two.
    (b) Specific requirements. The labels and labeling of any exported 
pesticides, devices, and active ingredients used in producing pesticides 
must meet the requirements regarding label and labeling content, correct 
representation, and understandability as stated in this paragraph.
    (1) Label contents. The term label means the written, printed, or 
graphic matter on or attached to the immediate container of the 
pesticide, device, or active ingredient used in producing a pesticide. 
In the case that the immediate container is enclosed in an outer 
container or wrapper through which the label cannot be read, the label 
must also be on such outer container or wrapper. Except as provided in 
paragraph (c) of this section, the immediate container of the pesticide, 
device, or active ingredient used in producing a pesticide must bear a 
conspicuous and readable label which includes:
    (i) EPA pesticide producing establishment number. The producing 
establishment registration number must be present but may appear 
anywhere on the label or immediate container in accordance with the 
establishment registration labeling requirements set forth in 
Sec. 156.10(f) of this chapter.
    (ii) Warning or caution statements. Warning or caution statements 
must appear on the label and must be adequate for the protection of 
persons handling the pesticide, device, or active ingredients including 
warnings regarding general toxicological hazards and environmental, 
physical, or chemical hazards. Warning and caution statements must 
appear in English and in the appropriate foreign languages, as described 
in paragraph (b)(4) of this section. Where the U.S. warning or caution 
statement, as translated, is obviously inappropriate to protect 
residents of the importing country, (for example, where a statement 
calls for a gas mask meeting the specification of the U.S. Bureau of 
Mines) an equivalent caution must be substituted.
    (iii) The statement ``Not Registered for Use in the United States of 
America.'' The labels of all pesticides, devices, and active ingredients 
which are not registered for use in the United States under FIFRA 
section 3 must prominently display the following statement: ``Not 
Registered for Use in the United States of America.'' The statement must 
appear in English and in appropriate foreign languages, as described in 
paragraph (b)(4) of this section. It is permissible to append 
explanatory text which qualifies the statement by pointing out the 
reasons for the unregistered status. Examples of possible additional 
statements are ``Not Registered for Use on...'', ``No Longer Registered 
for Use...'', or ``Not Registered...because...'' Such additions must not 
be misleading or misrepresent the registration status of the pesticide. 
The statement ``Not Registered For Use in the United States of America'' 
must also be present.
    (A) A pesticide is considered registered for the purposes of the 
section 17(a)(1) requirement only when:
    (1) A label and labeling approved under a current FIFRA section 3 
registration for the product is either attached to the immediate product 
container or accompanies the product at all times as supplemental 
labeling as provided in paragraph (c) of this section.
    (2) The formula of the exported product is the same as the formula 
of the U.S. registered product (within certified limits). In addition, a 
change in the color or fragrance of the export product will not affect 
the product's registration status, as long as the following conditions 
are met:
    (i) The change in color must result only from the addition of a dye 
included on the list of the chemicals exempted from the requirement of a 
tolerance at Sec. 180.1001, and the dye must not be a List 1 inert. 
(List 1 inerts are those inerts which the Agency has identified as 
presenting toxicological concerns. The classification of inerts is

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explained in EPA's Policy Statement on Inert Ingredients in Pesticide 
Products, which can be obtained from the Office of Pesticide Programs 
public docket, Room 1128, Crystal Mall 2, 1921 Jefferson Davis Highway, 
Arlington, Virginia 22202.)
    (ii) The change in fragrance must result only from the addition of a 
chemical included on the list of chemicals exempted from the requirement 
of a tolerance (Sec. 180.1001) and the chemical must not be a List 1 
inert.
    (iii) The change in fragrance must not result in a pesticide product 
containing a food or food-like fragrance. (See ``Food Fragrances in 
Pesticide Formulations,'' EPA's Office of Pesticide Programs Policy and 
Criteria Notice number 2155.1, November 20, 1975 which can be obtained 
from the Office of Pesticide Programs public docket, Room 1128, Crystal 
Mall 2, 1921 Jefferson Davis Highway, Arlington, Virginia 22202.).
    (iv) Any differences in color or fragrance of the export product in 
accordance with this section must be reflected in records which show the 
complete formula of the export product in accordance with the 
requirements of Sec. 169.2 and this policy.
    (3) No statements which appear on any of the product labels or 
labeling add new uses or claims or in any way contradict the approved 
FIFRA section 3 labeling. However, certain minor changes may be made to 
a product's labeling or packaging without affecting the registration 
status of the product, as specified in Sec. 152.46(b) of this chapter.
    (iv) The ingredient statement. The ingredient statement must appear 
on the label in English and in appropriate foreign languages (as 
described in paragraph (b)(4) of this section). If the English language 
description of the ingredients is easily identifiable and likely to be 
understood by the ordinary individual, the foreign language ingredient 
statement need not be included on the label. In the case of pesticide 
products, devices and active ingredients shipped solely for research and 
development purposes, it is permissible to use coded identification of 
ingredients on the label in order to protect confidentiality, in 
accordance with the requirements of Secs. 168.75(c) and 168.85(a).
    (v) Identity of parties. The name and address of the producer, 
registrant (if any), or the person for whom the pesticide was produced, 
must appear on the label.
    (vi) Weight or measure. The net weight must appear on the label in 
either English or metric units.
    (vii) Additional warning for highly toxic pesticides. If the 
pesticide, device or active ingredient is highly toxic to humans, the 
skull and crossbones, the word ``Poison'', and a statement of practical 
treatment must appear on the label. The word ``Poison'' and the 
statement of practical treatment shall be in English and in the 
appropriate foreign languages, as described in paragraph (b)(4) of this 
section. The skull and crossbones may be in red or black. For criteria 
on what pesticides are highly toxic, see Sec. 156.10(h) of this chapter.
    (2) Use classification statement. In addition to the label contents 
described in paragraph (b)(1) of this section, the labeling must include 
a use classification statement, if a use classification has been 
assigned under a FIFRA section 3 registration. The use classification 
shall accurately describe the use classification applicable to the U.S. 
registered use of the pesticide, device or active ingredient (e.g., 
``Restricted Use Pesticide''). Summary statements describing the use 
classification, e.g., ``For retail sale to and use only by Certified 
Applicators...'', or explaining what such terms mean are not required, 
but may be included if such statements do not result in false 
representation of the U.S. regulatory status of the pesticide. The use 
classification information may appear on the product label or on the 
labeling accompanying the pesticide product during shipment.
    (3) Misrepresentation. The labeling shall not make false or 
misleading representations or represent the product as an imitation of 
other products.
    (4) Understandability. The required statements must be expressed in 
such terms as to render them likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. To 
satisfy this

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section, certain information described in paragraph (b)(4)(i) of this 
section, which appears on the labeling of all exported pesticide 
products, devices and active ingredients must appear in English, in an 
acceptable language of the country of import as defined in paragraph 
(b)(4)(ii) of this section, and in an acceptable language of the country 
of final destination, if known or reasonably ascertainable by the 
exporter. When there are several official languages or dialects in a 
country, the language which is predominately spoken or written, or a 
language in which official government business is conducted, will be 
acceptable.
    (i) Information required to be multilingual. The following labeling 
information must be multilingual:
    (A) The warning and caution statements.
    (B) Where required, the statement ``Not Registered for Use in the 
United States of America.''
    (C) The ingredient statement.
    (D) Where required in accordance with paragraph (b)(1)(vii) of this 
section, the word ``Poison'' and the statement of practical treatment in 
case of poisoning.
    (ii) Acceptable languages. In all cases, English must be one of the 
languages used on the label or labeling. In addition, either the 
language which is used to conduct official government business, or the 
predominantly spoken or written language of the country of import must 
appear on the labeling. In each case where a country of final 
destination is known, the language which is used to conduct official 
government business or which is predominantly spoken in that country, if 
different from the language of the country of import, shall also appear 
on the labeling. In any case where English is predominantly spoken or 
written or is the language used to conduct official government business 
in a country, no other language need be included to meet the multiple 
language requirement of this paragraph.
    (c) Supplemental labeling. A pesticide, device or active ingredient 
intended for export will not be considered in violation of the labeling 
requirements of FIFRA when the label and/or labeling requirements stated 
in paragraph (b) of this section are met by supplemental labeling. 
Supplemental labeling must be attached to the immediate product 
container or the shipping container of the pesticide, device or active 
ingredient at all times when it is shipped or held for shipment to meet 
export label requirements. Supplemental labeling must meet all of the 
label requirements in paragraph (b) of this section which are not met by 
the immediate product labels. Supplemental labeling will satisfy the 
labeling requirements of FIFRA only if the following conditions are met:
    (1) Applicability. The use of supplemental labeling applies to any 
situation where the labeling requirements specified in this section are 
not met fully on the product label which is attached to the immediate 
product container. Any required label or labeling statement not met on 
the immediate container may be met through supplemental labeling.
    (2) Labeling contents and relation to shipment. If supplemental 
labeling is used to meet any of the labeling requirements of FIFRA 
section 17(a)(1), it must meet all of the requirements in paragraph (b) 
of this section which are not met by the label on the immediate product 
container. Thus, the supplemental labeling, together with the immediate 
product container label will meet all of the requirements of paragraph 
(b) of this section. Where used, supplemental labeling must be attached 
to or accompany the product shipping container of the pesticide, device, 
or active ingredient used in producing a pesticide at all times when 
shipped or held for shipment in the United States.



Sec. 168.75  Procedures for exporting unregistered pesticides--purchaser acknowledgement statements.

    This section describes how EPA interprets and will enforce 
requirements of FIFRA section 17(a)(2). Section 17(a)(2) provides that 
any person exporting a pesticide other than a pesticide registered for 
use under FIFRA section 3 or sold under FIFRA section 6(a)(1), shall 
obtain a statement signed by the foreign purchaser prior to export, 
acknowledging that the purchaser understands that such pesticide is not

[[Page 195]]

registered for use in the United States and cannot be sold in the United 
States. Section 17(a)(2) requires that a copy of the statement be 
transmitted to an appropriate official of the government of the 
importing country.
    (a) Products subject to the requirement. EPA will not consider an 
exporter of an unregistered pesticide to be in violation of FIFRA 
section 17(a)(2) if, prior to export of the pesticide, the exporter 
submits to EPA a statement signed by the foreign purchaser which affirms 
that the purchaser is aware that the pesticide is not registered for use 
in the United States and cannot be sold for use in the United States. 
The exporter must also include with the submission of the purchaser 
acknowledgement statement to EPA, a certification signed by the exporter 
affirming that the export did not occur until the statement signed by 
the foreign purchaser was obtained by the exporter. Except as provided 
in paragraph (b) of this section, all pesticide products produced for 
export which cannot be sold for use in the United States in the form 
that they are produced for export, are considered to be unregistered 
pesticides. This includes pesticides which are of a different 
formulation, including composition (except for variation within 
certified limits), or type of formulation, and pesticides which are 
packaged for use patterns for which they are not registered, which may 
be evidenced by package type or label use statements. This also includes 
unregistered products which are under development as pesticidal products 
and which are being exported for research testing.
    (b) Exceptions. Under the specific circumstances discussed below, 
EPA will not treat a registered product which has been modified slightly 
for export purposes, as unregistered for the purposes of the purchaser 
acknowledgement statement requirement. Any changes to the registered 
product for export purposes must be documented in accordance with the 
record-keeping requirements at Sec. 169.2 of this chapter and this 
policy.
    (1) Labeling on Immediate Product. EPA will not treat as 
unregistered for the purposes of section 17(a)(2), a registered 
pesticide product which cannot be sold or distributed for use in the 
United States because its immediate product container does not bear a 
label approved under a FIFRA section 3 registration, but which could be 
sold or distributed in the United States with the approved label 
attached to the immediate product container, provided that the label and 
labeling approved under a current FIFRA section 3 registration for the 
product is either attached to the immediate product container or 
accompanies the product at all times as supplemental labeling as 
provided in paragraph (c) of this section.
    (2) Packaging. (i) Certain changes may be made to a product's 
labeling or packaging without affecting the registration status of the 
product, as specified in Sec. 152.46(b) of this chapter and this policy. 
These changes include any changes in package size and label net 
contents, provided no change in use directions or requirement for child-
resistant packaging would be necessary for the product to be registered 
for use in the United States. For example, if child-resistant packaging 
is required for a particular pesticide product in the United States, and 
the product will be exported without child-resistant packaging, the 
product would be considered unregistered and therefore subject to all 
the requirements of FIFRA section 17(a), as described in Sec. 168.75 of 
this chapter including the requirement for a purchaser acknowledgement 
statement.
    (ii) If an exporter needed to repackage a product in a size to meet 
a foreign purchaser's specifications, that modification would not affect 
the registration status of the export product. Other modifications to 
the label used for export purposes which will not affect the export 
product's registration status are: the use of metric units for net 
contents, dosages, and other numeric expressions; the use of a different 
format for the label, provided that the information does not contradict 
the U.S. label; revision of non-mandatory U.S. label statements, 
consistent with 40 CFR part 156, including additions or changes required 
by other Federal statutes or regulations; a change of the name or 
address of the

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registrant, except for a change resulting from transfer of ownership, 
which requires that a registrant keep his name and address current with 
the Agency; and any correction of typographical or printing errors that 
appeared on the U.S. labeling. (See Sec. 152.46(b)).
    (3) Labeling statements. The following statements which appear on 
any of the product labels or labeling will not affect the status of the 
product, provided that they do not contradict the approved FIFRA section 
3 labeling:
    (i) It is permissible to add explanatory language which accurately 
explains the meaning of a use classification. For example, the statement 
``restricted use pesticide'' may be expanded to read: ``Restricted in 
the United States of America to use by certified applicators'' or 
``Restricted Use Pesticide. In The United States this product is 
restricted to use by applicators determined by each state to be 
competent in pesticide application and the human health and 
environmental consequences of misuse.'' If the explanatory language 
falsely represents or is misleading regarding the U.S. use 
classification, the product will be considered misbranded. In addition, 
a use classification can only be listed if one has been assigned 
pursuant to the U.S. registration.
    (ii) An exporter who is also the manufacturer of a U.S. registered 
pesticide may add new uses to the label of that product for export 
purposes, without triggering the requirements of section 17(a)(2), as 
long as the new uses are within the same general use patterns as those 
for the registered product. (Pesticide use patterns are listed in 
appendix A to 40 CFR part 158--Data Requirements for Registration: Use 
Pattern Index. The general pesticide use patterns are: terrestrial food 
crop and terrestrial nonfood crop; greenhouse food crop and greenhouse 
nonfood crop; aquatic food crop and aquatic nonfood crop; indoor use; 
and forestry use.) Adding new uses to the label which change the use 
pattern, such as changes from non-food to food use, outdoor to indoor 
use, or terrestrial to aquatic use, render the product unregistered and 
subject to the requirements of section 17 for unregistered products. If 
the new use added to the label is a food or feed use, a tolerance must 
already be established for the use of that pesticide in or on that 
commodity.
    (4) Composition. EPA will not treat a registered product as 
unregistered for the purposes of the purchaser acknowledgement statement 
requirement under the following specific circumstances:
    (i) The formula of the exported product is within certified limits 
of the formula of the U.S. registered product.
    (ii) An exporter, who is also the manufacturer of a U.S. registered 
pesticide, may decrease the percentage of the active ingredient(s) of 
that product by adding a List 4 inert ingredient, without causing the 
product to be treated as ``unregistered'' and triggering the requirement 
to obtain a purchaser acknowledgement statement as a condition for 
export. In EPA's Policy Statement on Inert Ingredients in Pesticide 
Products, EPA included inert ingredients on List 4-a list of inert 
ingredients posing minimal hazard or risk-if the inert ingredients were 
generally regarded as innocuous. The provisions of this paragraph do not 
apply to those pesticide products intended for public health uses which 
are required or conditionally required to submit efficacy data pursuant 
to Sec. 158.640 of this chapter. Any differences in formula or 
composition caused by adding a List 4 inert must be reflected in records 
which show the complete formula of the export product in accordance with 
the requirements of Sec. 169.2 and this policy.
    (iii) A change in the color or fragrance of the export product will 
not affect the product's registration status as long as the following 
conditions are met. The change in color must result only from the 
addition of a dye included on the list of the chemicals exempted from 
the requirement of a tolerance at Sec. 180.1001, and the dye must not be 
a List 1 inert. (List 1 inerts are those inerts which the Agency has 
identified as presenting toxicological concerns. The classification of 
inerts is explained in EPA's Policy Statement on Inert Ingredients in 
Pesticide Products. The change in fragrance must result only from the 
addition of a chemical included on the list of chemicals exempted from 
the requirement of a

[[Page 197]]

tolerance (Sec. 180.1001) and the chemical must not be a List 1 inert. 
The change in fragrance must not result in a pesticide product 
containing a food or food-like fragrance. (See ``Food Fragrances in 
Pesticide Formulations,'' EPA's Office of Pesticide Programs Policy and 
Criteria Notice number 2155.1, November 20, 1975.) Any difference in 
color or fragrance of the export product in accordance with this section 
must be reflected in records which show the complete formula of the 
export product in accordance with the requirements of Sec. 169.2 and 
this policy.
    (5) Research and development products. An unregistered pesticide 
product exported only for research and development purposes is subject 
to the notification requirements of this section, unless its use fits 
within the criteria described in this paragraph.
    (i) An unregistered pesticide product exported solely for research 
and development purposes will not be considered to be in violation of 
the notification requirements if the export of the research and 
development product:
    (A) Would not involve land uses of more than 10 acres (4.05 
hectares), or be used on or affect food or feed crops which are intended 
for consumption.
    (B) Would not involve aquatic uses of more than 1 acre (0.405 
hectares), or any aquatic uses which involve water used for irrigation, 
drinking or recreation, or be used on or affect plants or animals taken 
for food or feed from such waters.
    (C) Would not involve tests on animals intended for food or feed.
    (ii) Shipments to different purchasers, to different countries of 
final destination, or which occur more than a calendar year apart will 
be evaluated separately. When determining whether total shipments exceed 
the criteria described in this paragraph, EPA will evaluate the total 
amount of shipments by a single exporter during a calendar year for use 
in a particular country.
    (iii) An exporter bears the burden of demonstrating that the product 
meets these criteria before the research product is shipped. This may be 
met by documenting before the product is shipped and maintaining records 
for the time period required by Sec. 169.2(h) of this chapter from the 
date of the last shipment relevant to such records. The records to be 
maintained consist of:
    (A) The identity of the purchaser and country of intended use of the 
research product.
    (B) The amount shipped.
    (C) The intended research use by the purchaser, including the type 
of application site, rate of application, and measures taken for 
protection of humans from direct or dietary exposure.
    (c) Procedures. An exporter of an unregistered pesticide product 
must submit a purchaser acknowledgement statement to EPA containing the 
information stated in paragraph (c)(1) of this section, and a statement 
signed by the exporter certifying that the exportation did not occur 
until the signed acknowledgement statement had been obtained from the 
purchaser. If the foreign purchaser signs a purchaser acknowledgement 
statement in their own language, it must be accompanied by an English 
translation when it is submitted to EPA by the exporter. These 
statements shall be submitted in accordance with one of the two options 
for submission described in paragraph (c)(2) of this section.
    (1) Contents of the purchaser acknowledgement statements. The 
purchaser acknowledgement statement must include the following 
information in a format that is clearly understandable:
    (i) Name, address, and EPA identification number, if applicable, of 
the exporter.
    (ii) Name and address of the foreign purchaser.
    (iii) Identity of the product and the active ingredient(s), 
including:
    (A) The Chemical Abstract Services (CAS) Registry number for each 
active ingredient.
    (B) The chemical nomenclature for each active ingredient as used by 
the International Union of Pure and Applied Chemists (IUPAC).
    (C) Other known chemical or common names; or if the export involves 
a research product, a code name or identification number that can be 
used by EPA to identify the product from the exporter's records. If a 
code name or identification number is used, additional information must 
be attached to

[[Page 198]]

the certification statement submitted with the purchaser acknowledgement 
statement which will enable EPA to identify the product. This attached 
information may be claimed as confidential, and EPA will not forward 
this information with the purchaser acknowledgement statement to foreign 
governments.
    (iv) If known or reasonably ascertainable, the country or countries 
of final destination of the export shipment, i.e., where the exported 
pesticide is intended to be used, if different from the country of the 
foreign purchaser's address.
    (v) A statement that indicates that the foreign purchaser 
understands that the product is not registered for use in the United 
States and cannot be sold in the United States.
    (vi) The signature of the foreign purchaser.
    (vii) The date of the foreign purchaser's signature.
    (2) Reporting options. At the discretion of the exporter, the 
requirements of paragraph (c)(1) of this section may be met on a per-
shipment or annual basis, as stated in paragraphs (c)(2)(i) and 
(c)(2)(ii) of this section. If the procedures in paragraph (c)(2)(ii) of 
this section are not followed, EPA will consider paragraph (c)(2)(i) of 
this section, requiring pershipment purchaser acknowledgement 
statements, to be applicable in full. Where paragraph (c)(2)(i) of this 
section is applicable, each shipment which does not meet the 
requirements of that paragraph will be considered to be a separate 
violation of FIFRA.
    (i) Per-shipment purchaser acknowledgment statement. Unless the 
exporter chooses to follow the procedures described in paragraph 
(c)(2)(ii) of this section for the annual reporting procedures, the 
exporter must obtain and submit to EPA, a signed purchaser 
acknowledgement statement prior to each shipment of an unregistered 
pesticide according to the following procedures:
    (A) Prior to each shipment in a calendar year of an unregistered 
pesticide product to a particular purchaser in a foreign country, the 
exporter must provide the foreign purchaser with instructions about the 
required information on a purchaser acknowledgement statement, and 
inform the foreign purchaser that the pesticide product cannot be 
exported from the United States until the exporter has received from the 
foreign purchaser a properly completed, signed, and dated acknowledgment 
statement.
    (B) The exporter must obtain, prior to each shipment in a calendar 
year of an unregistered pesticide product to a particular purchaser in a 
foreign country, a signed purchaser acknowledgment statement which 
contains the information set forth in paragraph (c)(1) of this section.
    (C) The exporter must sign a statement certifying that export did 
not take place until a signed purchaser acknowledgement statement was 
received. The exporter must also specify the chemical identity of any 
research product which is referred to by code in the purchaser 
acknowledgement statement. The information regarding the specific 
identity of research products, which may be included in the statement or 
consist of an attachment to the certification, may be claimed as 
confidential.
    (D) The exporter must submit the signed acknowledgement statement 
from the foreign purchaser, and the accompanying certification by the 
exporter including attachments, to EPA within 7 working days of the 
exporter's receipt of the purchaser acknowledgement statement, or by the 
date of export, whichever occurs first. This information must be 
transmitted to the following address:

U.S. Environmental Protection Agency,
Office of Pesticide Programs, (H-7501C),
401 M Street, SW, Washington, DC 20460,
Attention: Purchaser Acknowledgement Statement.

    (ii) Annual reporting procedures. Unless the exporter chooses to 
follow the per-shipment reporting option described in paragraph 
(c)(2)(i) of this section, the exporter must follow the procedures for 
annual summary reporting which include the requirement of a purchaser 
acknowledgement statement for the first shipment each calendar year of 
an unregistered pesticide product to a particular purchaser, and an 
annual summary of shipments to that

[[Page 199]]

purchaser. The annual summary reporting procedures are as follows:
    (A) Prior to the first shipment each calendar year of an 
unregistered pesticide product to a particular purchaser in a foreign 
country, the exporter must provide the foreign purchaser with 
instructions about the required information on a purchaser 
acknowledgement statement, and inform the foreign purchaser that the 
pesticide product cannot be exported from the United States until the 
exporter has received from the foreign purchaser a properly completed, 
signed, and dated purchaser acknowledgement statement.
    (B) The exporter must obtain, prior to the first shipment each 
calendar year of an unregistered pesticide product to a particular 
purchaser in a foreign country, a signed purchaser acknowledgement 
statement which contains the information set forth in paragraph (c)(1) 
of this section.
    (C) The exporter must sign a statement certifying that export did 
not take place until a signed purchaser acknowledgement statement was 
received, indicating that this statement is for the first shipment to a 
particular purchaser in a specific country for that calendar year, and 
that the exporter will meet all the purchaser acknowledgement statement 
requirements as described in this paragraph (c)(2)(ii) of this section. 
The exporter must also specify the chemical identity of any research 
product which is referred to by code in the purchaser acknowledgement 
statement. The information regarding the specific identity of research 
products, which may be included in the statement or consist of an 
attachment to the certification, may be claimed as confidential.
    (D) The exporter must submit the signed acknowledgement statement 
from the foreign purchaser, and the accompanying certification by the 
exporter including attachments, to EPA within 7 working days of the 
exporter's receipt of the purchaser acknowledgement statement, or by the 
date of export, whichever occurs first. This information must be 
transmitted to the following address:

U.S. Environmental Protection Agency,
Office of Pesticide Programs, (H-7501C),
401 M Street, SW, Washington, DC 20460,
Attention: Purchaser Acknowledgement Statement.

    (E) The exporter, who has chosen to comply with the requirements of 
this paragraph instead of providing per-shipment purchaser 
acknowledgement statements in accordance with paragraph (c)(2)(i) of 
this section, must submit an annual summary report to EPA. An annual 
summary report is required for each unregistered pesticide exported 
within the preceding calendar year. The report must be in writing, 
signed by the exporter, and include the following information:
    (1) Name, address, and EPA identification number if applicable, of 
the exporter.
    (2) Name and address of the foreign purchaser, and the date the 
purchaser acknowledgement statement, submitted to EPA during the 
previous calendar year, was signed by the purchaser.
    (3) The identity of the product and the active ingredients, 
including: the Chemical Abstract Services (CAS) registry number for each 
active ingredient, the chemical nomenclature for each active ingredient 
used by the International Union of Pure and Applied Chemists (IUPAC), 
and other known chemical or common names, or if the export involves a 
research product, the code name or identification number that can be 
used by EPA to identify the product from the exporter's records.
    (4) The dates of each shipment of the pesticide exported to the 
foreign purchaser during that calendar year.
    (5) If known, or reasonably ascertainable, the country or countries 
of final destination of the export shipments, i.e., where the exported 
pesticide was intended to be used, if different from the foreign 
purchaser's address.
    (F) The exporter shall submit the annual summary no later than March 
1st of the following calendar year. The annual summary shall be sent to 
the following address:

U.S. Environmental Protection Agency,
Office of Pesticide Programs, H-7501C,
401 M Street, SW., Washington, DC 20460,
Attention: Annual Summary of Exports.

    (iii) Confidentiality claims. Persons submitting the information 
specified in

[[Page 200]]

the purchaser acknowledgement statement may assert a claim of business 
confidentiality by marking the information claimed confidential as 
``FIFRA Confidential Business Information.'' Information so claimed will 
not be disclosed, with the exception of disclosure to the foreign 
governments, except in accordance with the procedures set forth in 40 
CFR part 2, 7 U.S.C. 136(h), and this policy statement. If such claim is 
not asserted, EPA may disclose the information to the public without 
providing further notice prior to disclosure or an opportunity to 
object. Notwithstanding any claim of confidentiality, the purchaser 
acknowledgement statement will continue to be forwarded to the 
appropriate foreign government officials in its entirety, as required by 
section 17(a)(2).
    (3) Recordkeeping. Except as specifically stated, the requirement to 
retain records under part 169 of this chapter applies to all pesticide 
producers, regardless of whether a particular product is intended for 
export. All records shall be maintained in accordance with the time 
period required by Sec. 169.2(h) of this chapter. Producers must also 
maintain certain records pertaining to pesticide products intended for 
export. In addition to the requirement that a copy of the purchaser 
acknowledgement statement be kept, as stated at Sec. 169.2(h)(3) of this 
chapter, the following records must be maintained:
    (i) Copies of the instructions provided to foreign purchasers in 
accordance with paragraphs (c)(2)(i)(A) and (c)(2)(ii)(A) of this 
section.
    (ii) Copies of signed purchaser acknowledgement statements obtained 
according to paragraphs (c)(2)(i)(B) and (c)(2)(ii)(B) of this section.
    (iii) Copies of the certification from the exporter; and copies of 
any accompanying information regarding the identity of coded R&D 
products.
    (d) Agency transmission of purchaser acknowledgement statements. EPA 
will transmit a copy of each purchaser acknowledgement statement to the 
appropriate government official in each of the intended destination 
countries. After receipt of the Annual Summary the following calendar 
year, EPA will also transmit a copy of that document to the appropriate 
government official in each of the intended destination countries. In 
the case that no Annual Summary has been received within 30 days of the 
date at which such summary is required to be submitted, EPA will send 
written notification to the appropriate government official indicating 
that no summary was submitted, and may also take enforcement action 
against the exporter.



Sec. 168.85  Other export requirements.

    This section describes other requirements found in regulations that 
apply to exporters of pesticides, devices, and active ingredients used 
in producing a pesticide.
    (a) Recordkeeping and inspection. Exporters of pesticides, devices 
and active ingredients must keep records and permit inspections of those 
records in accordance with part 169 of this chapter. Exporters must keep 
records of the product labeling used, including the EPA registered 
labeling, any foreign labeling on or attached to the product when 
shipped, and, as applicable, any supplemental labeling used. Producers 
of pesticides for export shall maintain these records in a manner that 
shows exactly which labels and labeling accompanied each shipment of a 
pesticide product to a foreign country. As stated at Sec. 168.75(c), 
when research product identity information appears on the labeling in an 
encoded manner, information translating the code shall be maintained in 
records. These records shall be maintained for the time period required 
by Sec. 169.2(h) of this chapter following the last export of such 
pesticides. All records required by part 169 of this chapter shall be 
made available for inspection and copying by EPA or its duly authorized 
representatives.
    (b) Pesticide production establishment requirements. Exporters of 
pesticides, devices, and active ingredients must submit annual reports 
to EPA in accordance with part 167 of this chapter, concerning those 
products that are exported. All products required to be labeled ``Not 
Registered for Use in the United States of America'' must be reported as 
unregistered production regardless of whether a purchaser 
acknowledgement statement is required.

[[Page 201]]



PART 169--BOOKS AND RECORDS OF PESTICIDE PRODUCTION AND DISTRIBUTION--Table of Contents




Sec.
169.1  Definitions.
169.2  Maintenance of records.
169.3  Inspection.

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

    Source: 45 FR 54338, Aug. 15, 1980, unless otherwise noted.



Sec. 169.1  Definitions.

    Terms used in this part shall have the meanings set forth for such 
terms in the Federal Insecticide, Fungicide, and Rodenticide Act, as 
amended. In addition, as used in this part, the following terms shall 
have the meanings set forth below:
    (a) Amount of pesticide or active ingredient. The term ``amount of 
pesticide or active ingredient'' means the weight or volume of the 
pesticide or active ingredient used in producing a pesticide expressed 
as weight for solid or semi-solid products and as weight or volume of 
liquid products.
    (b) Batch. The term ``batch'' means a quantity of a pesticide 
product or active ingredient used in producing a pesticide made in one 
operation or lot or if made in a continuous or semi-continuous process 
or cycle, the quantity produced during an interval of time to be 
specified by the producer.
    (c) Device. The term ``device'' means any device or class of device 
as defined by the Act and determined by the Administrator to be subject 
to the provisions of the Act.
    (d) Inability. The term ``inability'' means the incapacity of any 
person to maintain, furnish or permit access to any records under this 
Act and regulations, where such incapacity arises out of causes beyond 
the control and without the fault or negligence of such person. Such 
causes may include, but are not restricted to acts of God or of the 
public enemy, fires, floods, epidemics, quarantine restrictions, 
strikes, and unusually severe weather, but in every case, the failure 
must be beyond the control and without the fault or negligence of said 
person.
    (e) Producer. The term ``producer'' means the person, as defined by 
the Act, who produces or imports any pesticide or device or active 
ingredient used in producing a pesticide.



Sec. 169.2  Maintenance of records.

    All producers of pesticides, devices, or active ingredients used in 
producing pesticides subject to this Act, including pesticides produced 
pursuant to an experimental use permit and pesticides, devices, and 
pesticide active ingredients produced for export, shall maintain the 
following records:
    (a) Records showing the product name, EPA Registration Number, 
Experimental Permit Number if the pesticide is produced under an 
Experimental Use Permit, amounts per batch and batch identification 
(numbers, letters, etc.) of all pesticides produced. In cases where the 
product is an active ingredient used in producing a pesticide or where 
the product is a pesticide which is not registered, is not the subject 
of an application for registration, or is not produced under an 
Experimental Use Permit, the records shall also show the complete 
formula. The batch identification shall appear on all production control 
records. These records shall be retained for a period of two (2) years.
    (b) Records showing the brand names and quantities of devices 
produced. These records shall be retained for a period of two (2) years.
    (c) Records showing the following information regarding the receipt, 
by the producer, of all pesticides, devices, and active ingredients used 
in producing pesticides:
    (1) Brand name of the pesticide or device, or common or chemical 
name of the pesticide active ingredient;
    (2) Name and address of shipper;
    (3) Name of delivering carrier;
    (4) Date received; and
    (5) Quantities received.

These records are not intended to cover receipt of pesticides used for 
in-plant maintenance, extermination, or sanitation programs, etc. 
Shipping and receiving documents such as invoices, freight bills, 
receiving tickets, etc., which provide the required information will be 
considered satisfactory for the purposes of this section. These records 
shall be retained for a period of two (2) years.

[[Page 202]]

    (d) Records showing the following information regarding the shipment 
of all pesticides, devices, and active ingredients used in producing 
pesticides:
    (1) Brand name of pesticide or device, or the common or chemical 
name of the pesticide active ingredient;
    (2) Name and address of consignee;
    (3) Where the pesticide is produced pursuant to an experimental use 
permit (FIFRA section 5), a special exemption (section 18), or a special 
local need (section 24), the information required under these sections 
and any regulations promulgated thereto regarding the distribution of 
such pesticides;
    (4) Name of originating carrier;
    (5) Date shipped or delivered for shipment; and
    (6) Quantities shipped or delivered for shipment.

Such records are required regardless of whether any shipment or receipt 
of shipment is between plants owned or otherwise controlled by the same 
person. Shipping and receiving documents such as invoices, freight 
bills, receiving tickets, etc., which provide the required information 
will be considered satisfactory for purposes of this section. These 
records shall be retained for a period of two (2) years.
    (e) Inventory records with respect to the types and amounts of 
pesticides or pesticide active ingredients, or quantities of devices in 
stock which he has produced. These records may be disposed of when a 
more current inventory record is prepared.
    (f) Copies of all domestic advertising of the restricted uses of any 
pesticide registered for restricted use which the producer caused to 
have prepared, including any radio or television scripts for all such 
pesticides. These records shall be retained for a period of two (2) 
years.
    (g) Copies of all guarantees given pursuant to section 12(a)(2)(C) 
of the Act. These records shall be retained for a period of one (1) year 
after expiration of the guarantee.
    (h) In the case of all pesticides, devices, and active ingredients 
used in producing pesticides intended solely for export to any foreign 
country:
    (1) Copies of the specification or directions of the foreign 
purchaser for the production of such pesticides, devices, or pesticide 
active ingredients;
    (2) Copies of labels or labeling required to comply with section 
17(a)(1) of the Act; and
    (3) For any pesticide other than a pesticide registered under 
section 3 or sold under section 6(a)(1) of the Act, copies of a 
statement signed by the foreign purchaser of the pesticide acknowledging 
that the purchaser understands that such pesticide is not registered for 
use in the United States and cannot be sold in the United States under 
this Act.

These records shall be retained for a period of 2 years after expiration 
of the contract.
    (i) Records on the method of disposal (burial, incineration, etc.) 
date or dates of disposal, location of the disposal sites, and the types 
and amounts of pesticides or pesticide active ingredients disposed of by 
the producer or his contractor. With regard to the disposal of 
containers accumulated during production, the Agency will consider 
satisfactory a statement, attested to by a responsible firm official, 
describing in general terms the method and location of disposal, e.g., 
all containers are taken periodically to a certain site. Records of 
deviations from normal practice must be maintained. In addition, any 
records on the disposal of pesticides or pesticide active ingredients 
and/or containers specified pursuant to section 19 of the Act and any 
regulations promulgated thereto shall also be maintained. The above 
requirements apply to those products bearing label instructions for 
disposal and to any other products specified under any regulations 
promulgated pursuant to section 19. These records shall be retained for 
twenty (20) years or may be forwarded after three (3) years to the 
Environmental Protection Agency Regional Administrator for maintenance. 
Notwithstanding these record keeping requirements, whenever any producer 
of pesticides or pesticide active ingredients is complying with a rule 
promulgated under the authority of the Resource Conservation and 
Recovery Act of 1976 (RCRA) (Pub. L. 94-580, 90 Stat. 2795, October 21, 
1976), for the handling

[[Page 203]]

or disposal of hazardous wastes, as defined by RCRA or any regulations 
promulgated thereunder, such producer will no longer be required to 
maintain records in accordance with this subsection.
    (j) Records of any tests conducted on human beings whether performed 
by the producer himself or authorized and/or paid for by the producer. 
Such records shall include: The names and addresses of subjects tested, 
dates of tests, types of tests, written consent of subjects to test, and 
all information and instructions given to the subjects regarding the 
nature and purpose of the tests and of any physical and mental health 
consequences which were reasonably foreseen therefrom, and any adverse 
effects of the test on the subjects, including any such effects coming 
to the attention of the producer after completion of the tests. These 
records shall be retained for twenty (20) years or may be forwarded 
after three (3) years to the Environmental Protection Agency Regional 
Administrator for maintenance.
    (k) Records containing research data relating to registered 
pesticides including all test reports submitted to the Agency in support 
of registration or in support of a tolerance petition, all underlying 
raw data, and interpretations and evaluations thereof, whether in the 
possession of the producer or in the possession of the independent 
testing facility or laboratory (if any) which performed such tests on 
behalf of the producer. These records shall be retained as long as the 
registration is valid and the producer is in business.

[45 FR 54338, Aug. 15, 1980, as amended at 58 FR 9090, Feb. 18, 1993]



Sec. 169.3  Inspection.

    (a) Producers. Any producer of any pesticide, device, or active 
ingredient used in producing a pesticide which is subject to this Act 
shall, upon request of any officer or employee of the Agency or of any 
State or political subdivision, duly designated by the Administrator, 
furnish or permit such person at all reasonable times to have access to 
and to copy all records required to be maintained by this part, 
including records in the possession of an independent testing facility 
or laboratory which performed tests on behalf of the producer. Such 
inspection will be conducted in accordance with procedures detailed in 
section 8(b) of the Act.
    (b) Distributors, carriers, dealers, etc. Any distributor, carrier, 
dealer, or any other person who sells or offers for sale, delivers or 
offers for delivery any pesticide, device, or active ingredient used in 
producing a pesticide which is subject to this Act, shall, upon request 
of any officer or employee of the Agency or of any State or political 
subdivision, duly designated by the Administrator, furnish or permit 
such person at all reasonable times to have access to and copy all 
records showing the delivery or holding of such pesticide, device, or 
active ingredient used in producing a pesticide, including the quantity, 
the date of shipment and receipt, and the name and address of the 
consignor and consignee, and any guarantee received pursuant to section 
12(b)(1) of the Act.
    (c) Confidentiality. Any record which is subject to the regulations 
under this part, and which may be confidential, shall be treated in 
accordance with the provisions of section 10 of the Act. The 
availability to the public of information provided to, or otherwise 
obtained by, the Administrator under this part shall be governed by part 
2 of this chapter.
    (d) Inability. (1) In the event of the inability of any person to 
produce records containing the information required to be maintained, 
furnished for inspection, or given access to, all other records and 
information regarding the same shall be provided.
    (2) Where no such inability exists and any such person fails to give 
access to and permit copying of such records as required, such failure 
shall be deemed a refusal to keep records required or a refusal to allow 
the inspection of any such records or both.



PART 170--WORKER PROTECTION STANDARD--Table of Contents




                      Subpart A--General Provisions

Sec.
170.1  Scope and purpose.
170.3  Definitions.
170.5  Effective date and compliance dates.
170.7  General duties and prohibited actions.

[[Page 204]]

170.9  Violations of this part.

                     Subpart B--Standard for Workers

170.102  Applicability of this subpart.
170.103  Exceptions.
170.104  Exemptions.
170.110  Restrictions associated with pesticide applications.
170.112  Entry restrictions.
170.120  Notice of applications.
170.122  Providing specific information about applications.
170.124  Notice of applications to handler employers.
170.130  Pesticide safety training for workers.
170.135  Posted pesticide safety information.
170.150  Decontamination.
170.160  Emergency assistance.

               Subpart C--Standard for Pesticide Handlers

170.202  Applicability of this subpart.
170.203  Exceptions.
170.204  Exemptions.
170.210  Restrictions during applications.
170.222  Providing specific information about applications.
170.224  Notice of applications to agricultural employers.
170.230  Pesticide safety training for handlers.
170.232  Knowledge of labeling and site-specific information.
170.234  Safe operation of equipment.
170.235  Posted pesticide safety information.
170.240  Personal protective equipment.
170.250  Decontamination.
170.260  Emergency assistance.

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

    Source: 57 FR 38151, Aug. 21, 1992, unless otherwise noted.



                      Subpart A--General Provisions



Sec. 170.1  Scope and purpose.

    This part contains a standard designed to reduce the risks of 
illness or injury resulting from workers' and handlers' occupational 
exposures to pesticides used in the production of agricultural plants on 
farms or in nurseries, greenhouses, and forests and also from the 
accidental exposure of workers and other persons to such pesticides. It 
requires workplace practices designed to reduce or eliminate exposure to 
pesticides and establishes procedures for responding to exposure-related 
emergencies.



Sec. 170.3  Definitions.

    Terms used in this part have the same meanings they have in the 
Federal Insecticide, Fungicide, and Rodenticide Act, as amended. In 
addition, the following terms, when used in this part, shall have the 
following meanings:
    Agricultural employer means any person who hires or contracts for 
the services of workers, for any type of compensation, to perform 
activities related to the production of agricultural plants, or any 
person who is an owner of or is responsible for the management or 
condition of an agricultural establishment that uses such workers.
    Agricultural establishment means any farm, forest, nursery, or 
greenhouse.
    Agricultural plant means any plant grown or maintained for 
commercial or research purposes and includes, but is not limited to, 
food, feed, and fiber plants; trees; turfgrass; flowers, shrubs; 
ornamentals; and seedlings.
    Chemigation means the application of pesticides through irrigation 
systems.
    Commercial pesticide handling establishment means any establishment, 
other than an agricultural establishment, that:
    (1) Employs any person, including a self-employed person, to apply 
on an agricultural establishment, pesticides used in the production of 
agricultural plants.
    (2) Employs any person, including a self-employed person, to perform 
on an agricultural establishment, tasks as a crop advisor.
    Crop advisor means any person who is assessing pest numbers or 
damage, pesticide distribution, or the status or requirements of 
agricultural plants. The term does not include any person who is 
performing hand labor tasks.
    Early entry means entry by a worker into a treated area on the 
agricultural establishment after a pesticide application is complete, 
but before any restricted-entry interval for the pesticide has expired.
    Farm means any operation, other than a nursery or forest, engaged in 
the outdoor production of agricultural plants.

[[Page 205]]

    Forest means any operation engaged in the outdoor production of any 
agricultural plant to produce wood fiber or timber products.
    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.
    Greenhouse means any operation engaged in the production of 
agricultural plants inside any structure or space that is enclosed with 
nonporous covering and that is of sufficient size to permit worker 
entry. This term includes, but is not limited to, polyhouses, mushroom 
houses, rhubarb houses, and similar structures. It does not include such 
structures as malls, atriums, conservatories, arboretums, or office 
buildings where agricultural plants are present primarily for aesthetic 
or climatic modification.
    Hand labor means any agricultural activity performed by hand or with 
hand tools that causes a worker to have substantial contact with 
surfaces (such as plants, plant parts, or soil) that may contain 
pesticide residues. These activities include, but are not limited to, 
harvesting, detasseling, thinning, weeding, topping, planting, sucker 
removal, pruning, disbudding, roguing, and packing produce into 
containers in the field. Hand labor does not include operating, moving, 
or repairing irrigation or watering equipment or performing the tasks of 
crop advisors.
    Handler means any person, including a self-employed person:
    (1) Who is employed for any type of compensation by an agricultural 
establishment or commercial pesticide handling establishment to which 
subpart C of this part applies and who is:
    (i) Mixing, loading, transferring, or applying pesticides.
    (ii) Disposing of pesticides or pesticide containers.
    (iii) Handling opened containers of pesticides.
    (iv) Acting as a flagger.
    (v) Cleaning, adjusting, handling, or repairing the parts of mixing, 
loading, or application equipment that may contain pesticide residues.
    (vi) Assisting with the application of pesticides.
    (vii) Entering a greenhouse or other enclosed area after the 
application and before the inhalation exposure level listed in the 
labeling has been reached or one of the ventilation criteria established 
by this part ( Sec. 170.110(c)(3)) or in the labeling has been met:
    (A) To operate ventilation equipment.
    (B) To adjust or remove coverings used in fumigation.
    (C) To monitor air levels.
    (viii) Entering a treated area outdoors after application of any 
soil fumigant to adjust or remove soil coverings such as tarpaulins.
    (ix) Performing tasks as a crop advisor:
    (A) During any pesticide application.
    (B) Before the inhalation exposure level listed in the labeling has 
been reached or one of the ventilation criteria established by this part 
(Sec. 170.110(c)(3)) or in the labeling has been met.
    (C) During any restricted-entry interval.
    (2) The term does not include any person who is only handling 
pesticide containers that have been emptied or cleaned according to 
pesticide product labeling instructions or, in the absence of such 
instructions, have been subjected to triple-rinsing or its equivalent.
    Handler employer means any person who is self-employed as a handler 
or who employs any handler, for any type of compensation.
    Immediate family includes only spouse, children, stepchildren, 
foster children, parents, stepparents, foster parents, brothers, and 
sisters.
    Nursery means any operation engaged in the outdoor production of any 
agricultural plant to produce cut flowers and ferns or plants that will 
be used in their entirety in another location. Such plants include, but 
are not limited to, flowering and foliage plants or trees; tree 
seedlings; live Christmas trees; vegetable, fruit, and ornamental 
transplants; and turfgrass produced for sod.
    Owner means any person who has a present possessory interest (fee, 
leasehold, rental, or other) in an agricultural establishment covered by 
this part. A person who has both leased

[[Page 206]]

such agricultural establishment to another person and granted that same 
person the right and full authority to manage and govern the use of such 
agricultural establishment is not an owner for purposes of this part.
    Restricted-entry interval means the time after the end of a 
pesticide application during which entry into the treated area is 
restricted.
    Treated area means any area to which a pesticide is being directed 
or has been directed.
    Worker means any person, including a self-employed person, who is 
employed for any type of compensation and who is performing activities 
relating to the production of agricultural plants on an agricultural 
establishment to which subpart B of this part applies. While persons 
employed by a commercial pesticide handling establishment are performing 
tasks as crop advisors, they are not workers covered by the requirements 
of subpart B of this part.



Sec. 170.5  Effective date and compliance dates.

    (a) Effective date. The effective date for this part, including 
Sec. 170.112(e), shall be October 20, 1992.
    (b) Accelerated provisions. The compliance date shall be April 21, 
1993, for:
    (1) Section 170.112(a) through (c)(3);
    (2) Section 170.112(d)(1) through (d)(2)(ii);
    (3) The requirement of Sec. 170.112(c)(3) as referenced in 
Sec. 170.112(d)(2)(iii);
    (4) The requirement of Sec. 170.112(c)(3) as referenced in 
Sec. 170.112(e)(5);
    (5) Section 170.120(a)(3); and
    (6) Section 170.120(b)(3).
    (c) All other provisions. The compliance date for all other 
provisions of this part shall be April 15, 1994.



Sec. 170.7  General duties and prohibited actions.

    (a) General duties. The agricultural employer or the handler 
employer, as appropriate, shall:
    (1) Assure that each worker subject to subpart B of this part or 
each handler subject to subpart C of this part receives the protections 
required by this part.
    (2) Assure that any pesticide to which subpart C of this part 
applies is used in a manner consistent with the labeling of the 
pesticide, including the requirements of this part.
    (3) Provide, to each person who supervises any worker or handler, 
information and directions sufficient to assure that each worker or 
handler receives the protections required by this part. Such information 
and directions shall specify which persons are responsible for actions 
required to comply with this part.
    (4) Require each person who supervises any worker or handler to 
assure compliance by the worker or handler with the provisions of this 
part and to assure that the worker or handler receives the protections 
required by this part.
    (b) Prohibited actions. The agricultural employer or the handler 
employer shall not take any retaliatory action for attempts to comply 
with this part or any action having the effect of preventing or 
discouraging any worker or handler from complying or attempting to 
comply with any requirement of this part.



Sec. 170.9  Violations of this part.

    (a) Under the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.) (FIFRA) section 12(a)(2)(G) it is unlawful for any 
person ``to use any registered pesticide in a manner inconsistent with 
its labeling.'' When this part is referenced on a label, users must 
comply with all of its requirements except those that are inconsistent 
with product-specific instructions on the labeling. For the purposes of 
this part, EPA interprets the term ``use'' to include:
    (1) Preapplication activities, including, but not limited to:
    (i) Arranging for the application of the pesticide;
    (ii) Mixing and loading the pesticide; and
    (iii) Making necessary preparations for the application of the 
pesticide, including responsibilities related to worker notification, 
training of handlers, decontamination, use and care of personal 
protective equipment, emergency information, and heat stress management.
    (2) Application of the pesticide.
    (3) Post-application activities necessary to reduce the risks of 
illness and

[[Page 207]]

injury resulting from handlers' and workers' occupational exposures to 
pesticide residues during the restricted-entry interval plus 30 days. 
These activities include, but are not limited to, responsibilities 
related to worker training, notification, and decontamination.
    (4) Other pesticide-related activities, including, but not limited 
to, providing emergency assistance, transporting or storing pesticides 
that have been opened, and disposing of excess pesticides, spray mix, 
equipment wash waters, pesticide containers, and other pesticide-
containing materials.
    (b) A person who has a duty under this part, as referenced on the 
pesticide product label, and who fails to perform that duty, violates 
FIFRA section 12(a)(2)(G) and is subject to a civil penalty under 
section 14. A person who knowingly violates section 12(a)(2)(G) is 
subject to section 14 criminal sanctions.
    (c) FIFRA section 14(b)(4) provides that a person is liable for a 
penalty under FIFRA if another person employed by or acting for that 
person violates any provision of FIFRA. The term ``acting for'' includes 
both employment and contractual relationships.
    (d) The requirements of this part, including the decontamination 
requirements, shall not, for the purposes of section 653(b)(1) of title 
29 of the U.S. Code, be deemed to be the exercise of statutory authority 
to prescribe or enforce standards or regulations affecting the general 
sanitary hazards addressed by the OSHA Field Sanitation Standard, 29 CFR 
1928.110, or other agricultural, nonpesticide hazards.



                     Subpart B--Standard for Workers



Sec. 170.102  Applicability of this subpart.

    Except as provided by Secs. 170.103 and 170.104, this subpart 
applies when any pesticide product is used on an agricultural 
establishment in the production of agricultural plants.

[60 FR 21952, May 3, 1995]



Sec. 170.103  Exceptions.

    Exceptions. This subpart does not apply when any pesticide is 
applied on an agricultural establishment in the following circumstances:
    (a) For mosquito abatement, Mediterranean fruit fly eradication, or 
similar wide-area public pest control programs sponsored by governmental 
entities;
    (b) On livestock or other animals, or in or about animal premises;
    (c) On plants grown for other than commercial or research purposes, 
which may include plants in habitations, home fruit and vegetable 
gardens, and home greenhouses;
    (d) On plants that are in ornamental gardens, parks, and public or 
private lawns and grounds that are intended only for aesthetic purposes 
or climatic modification;
    (e) By injection directly into agricultural plants. Direct injection 
does not include ``hack and squirt,'' ``frill and spray,'' chemigation, 
soil-incorporation, or soil-injection;
    (f) In a manner not directly related to the production of 
agricultural plants, including, but not limited to, structural pest 
control, control of vegetation along rights-of-way and in other noncrop 
areas, and pasture and rangeland use;
    (g) For control of vertebrate pests;
    (h) As attractants or repellents in traps;
    (i) On the harvested portions of agricultural plants or on harvested 
timber; and
    (j) For research uses of unregistered pesticides.

[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]



Sec. 170.104  Exemptions.

    The workers listed in this section are exempt from the specified 
provisions of this subpart.
    (a) Owners of agricultural establishments. (1) The owner of an 
agricultural establishment is not required to provide to himself or 
members of his immediate family who are performing tasks related to the 
production of agricultural plants on their own agricultural 
establishment the protections of:
    (i) Section 170.112(c)(5) through (9).
    (ii) Section 170.112(c)(5) through (9) as referenced in 
Secs. 170.112(d)(2)(iii) and 170.112(e).
    (iii) Section 170.120.

[[Page 208]]

    (iv) Section 170.122.
    (v) Section 170.130.
    (vi) Section 170.135.
    (vii) Section 170.150.
    (viii) Section 170.160.
    (2) The owner of the agricultural establishment must provide the 
protections listed in paragraph (a)(1)(i) through (viii) of this section 
to other workers and other persons who are not members of his immediate 
family.
    (b) Crop advisors. (1) Provided that the conditions of paragraph 
(b)(2) of this section are met, a person who is certified or licensed as 
a crop advisor by a program acknowledged as appropriate in writing by 
EPA or a State or Tribal lead agency for pesticide enforcement, and 
persons performing crop advising tasks under such qualified crop 
advisor's direct supervision, are exempt from the provisions of:
    (i) Section 170.150.
    (ii) Section 170.160.

A person is under the direct supervision of a crop advisor when the crop 
advisor exerts the supervisory controls set out in paragraphs 
(b)(2)(iii) and (iv) of this section. Direct supervision does not 
require that the crop advisor be physically present at all times, but 
the crop advisor must be readily accessible to the employees at all 
times.
    (2) Conditions of exemption. (i) The certification or licensing 
program requires pesticide safety training that includes, at least, all 
the information in Sec. 170.230(c)(4).
    (ii) Applies only when performing crop advising tasks in the treated 
area.
    (iii) The crop advisor must make specific determinations regarding 
the appropriate PPE, appropriate decontamination supplies, and how to 
conduct the tasks safely. The crop advisor must convey this information 
to each person under his direct supervision in a language that the 
person understands.
    (iv) Before entering a treated area, the certified or licensed crop 
advisor must inform, through an established practice of communication, 
each person under his direct supervision of the pesticide product and 
active ingredient(s) applied, method of application, time of 
application, the restricted entry interval, which tasks to undertake, 
and how to contact the crop advisor.
    (c) Grace period for persons performing crop advisor tasks who are 
not certified or licensed. (1) Provided that the conditions of paragraph 
(c)(2) of this section are met, a person who is neither certified nor 
licensed as a crop advisor and any person performing crop advising tasks 
under his direct supervision is exempt until May 1, 1996, from the 
requirements of:
    (i) Section 170.130.
    (ii) Section 170.150.
    (iii) Section 170.160.
    (2) Conditions of exemption. (i) Applies only when the persons are 
performing crop advising tasks in the treated area.
    (ii) The crop advisor must make specific determinations regarding 
the appropriate PPE, appropriate decontamination supplies, and how to 
conduct the tasks safely. The crop advisor must convey this information 
to each person under his direct supervision in a language that the 
person understands.
    (iii) Before entering a treated area, the crop advisor must inform, 
through an established practice of communication, each person under his 
direct supervision of the active ingredient, method of application, time 
of application, the restricted entry interval, which tasks to undertake, 
and how to contact the crop advisor.

[60 FR 21952, May 3, 1995]



Sec. 170.110  Restrictions associated with pesticide applications.

    (a) Farms and forests. During the application of any pesticide on a 
farm or in a forest, the agricultural employer shall not allow or direct 
any person, other than an appropriately trained and equipped handler, to 
enter or to remain in the treated area.
    (b) Nurseries. In a nursery, during any pesticide application 
described in column A of Table 1 of this paragraph, the agricultural 
employer shall not allow or direct any person, other than an 
appropriately trained and equipped handler, to enter or to remain in the 
area specified in column B of Table 1 of this paragraph. After the 
application is completed, until the end of any restricted-entry 
interval, the entry-restricted area is the treated area.

[[Page 209]]



      Table 1--Entry-Restricted Areas in Nurseries During Pesticide
                              Applications
------------------------------------------------------------------------
                                              B. Workers are Prohibited
   A. During Application of a Pesticide:                 in:
------------------------------------------------------------------------
(1)(a) Applied:                              Treated area plus 100 feet
                                              in all directions on the
                                              nursery
    (i) Aerially, or
    (ii) In an upward direction, or
    (iii) Using a spray pressure greater
     than 150 psi, or
  (b) Applied as a:
    (i) Fumigant, or
    (ii) Smoke, or
    (iii) Mist, or
    (iv) Fog, or
    (v) Aerosol.
(2)(a) Applied downward using:               Treated are plus 25 feet in
                                              all directions on the
                                              nursery
    (i) A height of greater than 12 inches
     from the planting medium, or
    (ii) A fine spray, or
    (iii) A spray pressure greater than 40
     psi and less than 150 psi.
  (b) Not as in 1 or 2(a) above but for
   which a respiratory protection device is
   required for application by the product
   labeling.
(3) Applied otherwise.                       Treated area
------------------------------------------------------------------------

    (c) Greenhouses. (1) When a pesticide application described in 
column A of Table 2 under paragraph (c)(4) of this section takes place 
in a greenhouse, the agricultural employer shall not allow or direct any 
person, other than an appropriately trained and equipped handler, to 
enter or to remain in the area specified in column B of Table 2 until 
the time specified in column C of Table 2 has expired.
    (2) After the time specified in column C of Table 2 under paragraph 
(c)(4) of this section has expired, until the expiration of any 
restricted-entry interval, the agricultural employer shall not allow or 
direct any worker to enter or to remain in the treated area as specified 
in column D of Table 2 under paragraph (c)(4) of this section, except as 
provided in Sec. 170.112.
    (3) When column C of Table 2 under paragraph (c)(4) of this section 
specifies that ventilation criteria must be met, ventilation shall 
continue until the air concentration is measured to be equal to or less 
than the inhalation exposure level the labeling requires to be achieved. 
If no inhalation exposure level is listed on the labeling, ventilation 
shall continue until after:
    (i) Ten air exchanges are completed; or
    (ii) Two hours of ventilation using fans or other mechanical 
ventilating systems; or
    (iii) Four hours of ventilation using vents, windows or other 
passive ventilation; or
    (iv) Eleven hours with no ventilation followed by 1 hour of 
mechanical ventilation; or
    (v) Eleven hours with no ventilation followed by 2 hours of passive 
ventilation; or
    (vi) Twenty-four hours with no ventilation.
    (4) The following Table 2 applies to paragraphs (c) (1), (2), and 
(3) of this section.

                  Table 2--Greenhouse Entry Restrictions Associated With Pesticide Applications
----------------------------------------------------------------------------------------------------------------
                                                                                         D. After the Expiration
                                                                                           of Time in Column C
                                            B. Workers are                                Until the Restricted-
   A. When a Pesticide is Applied:          Prohibited in:             C. Until:         Entry Interval Expires,
                                                                                           the Entry-Restricted
                                                                                                 Area is:
----------------------------------------------------------------------------------------------------------------
(1) As a fumigant                      Entire greenhouse plus   The ventilation          No entry restrictions
                                        any adjacent structure   criteria of paragraph    after criteria in
                                        that cannot be sealed    (c)(3) of this section   column C are met
                                        off from the treated     are met
                                        area
(2) As a                               Entire enclosed area     The ventilation          Entire enclosed area is
                                                                 criteria of paragraph    the treated area
                                                                 (c)(3) of this section
                                                                 are met
  (i) Smoke, or
  (ii) Mist, or
  (iii) Fog, or

[[Page 210]]

 
  (iv) Aerosol
(3) Not in 1 or 2 above, and for       Entire enclosed area     The ventilation          Treated area
 which a respiratory protection                                  criteria of paragraph
 device is required for application                              (c)(3) of this section
 by the product labeling                                         are met
(4) Not in 1, 2, or 3 above, and:      Treated area plus 25     Application is complete  Treated area
                                        feet in all directions
                                        in the enclosed area
  (i) From a height of greater than
   12 in. from the planting medium,
   or
  (ii) As a fine spray, or
  (iii) Using a spray pressure
   greater than 40 psi
(5) Otherwise                          Treated area             Application is complete  Treated area
----------------------------------------------------------------------------------------------------------------



Sec. 170.112  Entry restrictions.

    (a) General restrictions. (1) After the application of any pesticide 
on an agricultural employer shall not allow or direct any worker to 
enter or to remain in the treated area before the restricted-entry 
interval specified on the pesticide labeling has expired, except as 
provided in this section.
    (2) Entry-restricted areas in greenhouses are specified in column D 
in table 2 under Sec. 170.110(c)(4).
    (3) When two or more pesticides are applied at the same time, the 
restricted-entry interval shall be the longest of the applicable 
intervals.
    (4) The agricultural employer shall assure that any worker who 
enters a treated area under a restricted-entry interval as permitted by 
paragraphs (c), (d), and (e) of this section uses the personal 
protective equipment specified in the product labeling for early-entry 
workers and follows any other requirements on the pesticide labeling 
regarding early entry.
    (b) Exception for activities with no contact. A worker may enter a 
treated area during a restricted-entry interval if the agricultural 
employer assures that both of the following are met:
    (1) The worker will have no contact with anything that has been 
treated with the pesticide to which the restricted-entry interval 
applies, including, but not limited to, soil, water, air, or surfaces of 
plants; and
    (2) No such entry is allowed until any inhalation exposure level 
listed in the labeling has been reached or any ventilation criteria 
established by Sec. 170.110(c)(3) or in the labeling have been met.
    (c) Exception for short-term activities. A worker may enter a 
treated area during a restricted-entry interval for short-term 
activities if the agricultural employer assures that the following 
requirements are met:
    (1) No hand labor activity is performed.
    (2) The time in treated areas under a restricted-entry interval for 
any worker does not exceed 1 hour in any 24-hour period.
    (3) No such entry is allowed for the first 4 hours following the end 
of the application, and no such entry is allowed thereafter until any 
inhalation exposure level listed in the labeling has been reached or any 
ventilation criteria established by Sec. 170.110(c)(3) or in the 
labeling have been met.
    (4) The personal protective equipment specified on the product 
labeling for early entry is provided to the worker. Such personal 
protective equipment

[[Page 211]]

shall conform to the following standards:
    (i) Personal protective equipment (PPE) means devices and apparel 
that are worn to protect the body from contact with pesticides or 
pesticide residues, including, but not limited to, coveralls, chemical-
resistant suits, chemical-resistant gloves, chemical-resistant footwear, 
respiratory protection devices, chemical-resistant aprons, chemical-
resistant headgear, and protective eyewear.
    (ii) Long-sleeved shirts, short-sleeved shirts, long pants, short 
pants, shoes, socks, and other items of work clothing are not considered 
personal protective equipment for the purposes of this section and are 
not subject to the requirements of this section, although pesticide 
labeling may require that such work clothing be worn during some 
activities.
    (iii) When ``chemical-resistant'' personal protective equipment is 
specified by the product labeling, it shall be made of material that 
allows no measurable movement of the pesticide being used through the 
material during use.
    (iv) When ``waterproof'' personal protective equipment is specified 
by the product labeling, it shall be made of material that allows no 
measurable movement of water or aqueous solutions through the material 
during use.
    (v) When a ``chemical-resistant suit'' is specified by the product 
labeling, it shall be a loose-fitting, one- or two-piece, chemical-
resistant garment that covers, at a minimum, the entire body except 
head, hands, and feet.
    (vi) When ``coveralls'' are specified by the product labeling, they 
shall be a loose-fitting, one- or two-piece garment, such as a cotton or 
cotton and polyester coverall, that covers, at a minimum, the entire 
body except head, hands, and feet. The pesticide product labeling may 
specify that the coveralls be worn over a layer of clothing. If a 
chemical-resistant suit is substituted for coveralls, it need not be 
worn over a layer of clothing.
    (vii) Gloves shall be of the type specified by the product labeling. 
Gloves or glove linings made of leather, cotton, or other absorbent 
materials must not be worn for early-entry activities unless these 
materials are listed on the product labeling as acceptable for such use. 
If chemical-resistant gloves with sufficient durability and suppleness 
are not obtainable for tasks with roses or other plants with sharp 
thorns, leather gloves may be worn over chemical-resistant liners. 
However, once leather gloves have been worn for this use, thereafter 
they shall be worn only with chemical-resistant liners and they shall 
not be worn for any other use.
    (viii) When ``chemical-resistant footwear'' is specified by the 
product labeling, it shall be one of the following types of footwear: 
chemical-resistant shoes, chemical-resistant boots, or chemical-
resistant shoe coverings worn over shoes or boots. If chemical-resistant 
footwear with sufficient durability and a tread appropriate for wear in 
rough terrain is not obtainable for workers, then leather boots may be 
worn in such terrain.
    (ix) When ``protective eyewear'' is specified by the product 
labeling, it shall be one of the following types of eyewear: goggles; 
face shield; safety glasses with front, brow, and temple protection; or 
a full-face respirator.
    (x) When ``chemical-resistant headgear'' is specified by the product 
labeling, it shall be either a chemical-resistant hood or a chemical-
resistant hat with a wide brim.
    (5) The agricultural employer shall assure that the worker, before 
entering the treated area, either has read the product labeling or has 
been informed, in a manner that the worker can understand, of all 
labeling requirements related to human hazards or precautions, first 
aid, symptoms of poisoning, personal protective equipment specified for 
early entry, and any other labeling requirements related to safe use.
    (6) The agricultural employer shall assure that:
    (i) Workers wear the personal protective equipment correctly for its 
intended purpose and use personal protective equipment according to 
manufacturer's instructions.
    (ii) Before each day of use, all personal protective equipment is 
inspected for leaks, holes, tears, or worn places, and any damaged 
equipment is repaired or discarded.

[[Page 212]]

    (iii) Personal protective equipment that cannot be cleaned properly 
is disposed of in accordance with any applicable Federal, State, and 
local regulations.
    (iv) All personal protective equipment is cleaned according to 
manufacturer's instructions or pesticide product labeling instructions 
before each day of reuse. In the absence of any such instructions, it 
shall be washed thoroughly in detergent and hot water.
    (v) Before being stored, all clean personal protective equipment is 
dried thoroughly or is put in a well-ventilated place to dry.
    (vi) Personal protective equipment contaminated with pesticides is 
kept separately and washed separately from any other clothing or 
laundry.
    (vii) Any person who cleans or launders personal protective 
equipment is informed that such equipment may be contaminated with 
pesticides, of the potentially harmful effects of exposure to 
pesticides, and of the correct way(s) to handle and clean personal 
protective equipment and to protect themselves when handling equipment 
contaminated with pesticides.
    (viii) All clean personal protective equipment is stored separately 
from personal clothing and apart from pesticide-contaminated areas.
    (ix) Each worker is instructed how to put on, use, and remove the 
personal protective equipment and is informed about the importance of 
washing thoroughly after removing personal protective equipment.
    (x) Each worker is instructed in the prevention, recognition, and 
first aid treatment of heat-related illness.
    (xi) Workers have a clean place(s) away from pesticide-storage and 
pesticide-use areas for storing personal clothing not in use; putting on 
personal protective equipment at the start of any exposure period; and 
removing personal protective equipment at the end of any exposure 
period.
    (7) When personal protective equipment is required by the labeling 
of any pesticide for early entry, the agricultural employer shall assure 
that no worker is allowed or directed to perform the early-entry 
activity without implementing, when appropriate, measures to prevent 
heat-related illness.
    (8) During any early-entry activity, the agricultural employer shall 
provide a decontamination site in accordance with Sec. 170.150.
    (9) The agricultural employer shall not allow or direct any worker 
to wear home or to take home personal protective equipment contaminated 
with pesticides.
    (d) Exception for an agricultural emergency. (1) An ``agricultural 
emergency'' means a sudden occurrence or set of circumstances which the 
agricultural employer could not have anticipated and over which the 
agricultural employer has no control, and which requires entry into a 
treated area during a restricted-entry interval, when no alternative 
practices would prevent or mitigate a substantial economic loss. A 
substantial economic loss means a loss in profitability greater than 
that which would be expected based on the experience and fluctuations of 
crop yields in previous years. Only losses caused by the agricultural 
emergency specific to the affected site and geographic area are 
considered. The contribution of mismanagement cannot be considered in 
determining the loss.
    (2) A worker may enter a treated area under a restricted-entry 
interval in an agricultural emergency to perform tasks, including hand 
labor tasks, necessary to mitigate the effects of the agricultural 
emergency, if the agricultural employer assures that all the following 
criteria are met:
    (i) A State, Tribal, or Federal Agency having jurisdiction declares 
the existence of circumstances that could cause an agricultural 
emergency on that agricultural establishment.
    (ii) The agricultural employer determines the agricultural 
establishment is subject to the circumstances declared under paragraph 
(d)(2)(i) of this section that result in an agricultural emergency 
meeting the criteria of paragraph (d)(1) of this section.
    (iii) The requirements of paragraphs (c) (3) through (9) of this 
section are met.
    (e) Exception requiring Agency approval. The Agency may, in 
accordance with paragraphs (e) (1) through (3) of this section, grant an 
exception from the requirements of this section. An

[[Page 213]]

exception may be withdrawn in accordance with paragraph (e)(6) of this 
section.
    (1) Requesting an exception. A request for an exception must be 
submitted to the Director, Office of Pesticide Programs (H-7501C), 
Environmental Protection Agency, 401 M Street, SW., Washington, DC 20460 
and must be accompanied by two copies of the following information:
    (i) The name, address, and telephone number of the submitter.
    (ii) The time period for which the exception is requested.
    (iii) A description of the crop(s) and specific crop production 
task(s) for which the exception is requested. Such a description must 
include an explanation as to the necessity of applying pesticides of a 
type and at a frequency such that the restricted-entry interval would 
interfere with necessary and time-sensitive hand labor tasks for the 
period for which the exception is sought.
    (iv) A description of the geographic area for which the exception is 
requested. If the exception request is for a limited geographic area, 
the explanation must include a description as to why the circumstances 
of exposure or economic impact resulting from the prohibition of routine 
hand labor tasks during the restricted-entry interval are unique to the 
geographic area named in the exception.
    (v) An explanation as to why, for each requested crop-task 
combination, alternative practices would not be technically or 
financially viable. Such alternative practices might include: 
rescheduling the pesticide application or hand labor activity; using a 
non-chemical pest control alternative; using an alternative to the hand 
labor tasks, such as machine cultivation; or substituting a pesticide 
with a shorter restricted-entry interval. This information should 
include estimates or data on per acre revenue and cost of production for 
the crop and area for which the exception is requested. These estimates 
or data should include: the situation prior to implementation of this 
final rule, the situation after implementation of this final rule if the 
exception is not granted, the situation after implementation of this 
final rule if the exception is granted, and specific information on 
individual factors which cause differences in revenues and costs among 
the three situations.
    (vi) A description or documentation of the safety and feasibility of 
such an exception, including, but not limited to, the feasibility of 
performing the necessary hand labor activity while wearing the personal 
protective equipment required for early entry for the pesticide(s) 
expected to be applied, the means of mitigating heat-related illness 
concerns, the period of time required daily per worker to perform the 
hand labor activity, any suggested methods of reducing the worker's 
exposure, and any other mitigating factors, such as the availability of 
running water for routine and emergency decontamination and mechanical 
devices that would reduce the workers' contact with the treated 
surfaces. The information should include the costs associated with 
early-entry, such as decontamination facilities, special information and 
training for the workers, heat stress avoidance procedures, and 
provision, inspection, cleaning, and maintenance of personal protective 
equipment. EPA will not grant exceptions where the costs of early entry 
equal or exceed the expected loss in value of crop yield or quality.
    (2) Notice of receipt. (i) When a request for an exception is 
submitted to the Agency along with all of the information required in 
paragraph (e)(1) of this section, the Agency shall issue a notice in the 
Federal Register stating that an exception is being considered, 
describing the nature of the exception, and allowing at least 30 days 
for interested parties to comment.
    (ii) If a request for an exception is submitted to the Agency 
without all of the information required in paragraph (e)(1) of this 
section, the Agency shall return the request to the submitter.
    (3) Exception decision. EPA will publish in the Federal Register its 
decision whether to grant the request for exception. EPA will base its 
decision on whether the benefits of the exception outweigh the costs, 
including the value of the health risks attributable to the exception. 
If the exception is granted, the notice will state the nature of and 
reasons for the exception.

[[Page 214]]

    (4) Presumptive denial. (i) Except as provided in paragraph 
(e)(4)(ii) of this section, persons requesting an exception may assume 
that the exception has been denied if EPA has not issued its decision 
whether to grant the exception within 9 months from the comment-closure 
date specified in the Federal Register notice in which the Agency 
announced, in accordance with paragraph (e)(2) of this section, that it 
would consider the exception.
    (ii) Persons requesting an exception may not assume that the request 
has been denied as provided by paragraph (e)(4)(i) of this section if 
the Agency has taken action to extend its review period for a specified 
time interval due to the complexity of the exception request or to the 
number of exception requests concurrently under Agency review. EPA shall 
state the reason(s) for the delay in issuing a decision on the exception 
request. A notice of such an action may be published in the Federal 
Register or persons who requested the exception may be directly notified 
of the action.
    (5) Agricultural employer duties. When a worker enters a treated 
area during a restricted-entry interval under an exception granted under 
paragraph (e) of this section, the agricultural employer shall assure 
that the requirements of paragraphs (c) (3) through (9) of this section 
are met, unless the notice granting the exception specifically indicates 
otherwise.
    (6) Withdrawing an exception. An exception may be withdrawn by the 
Agency at any time if the Agency receives poisoning information or other 
data that indicate that the health risks imposed by this early-entry 
exception are unacceptable or if the Agency receives other information 
that indicates that the exception is no longer necessary or prudent. If 
the Agency determines that an exception should be withdrawn, it will 
publish a notice in the Federal Register, stating the basis for its 
determination. Affected parties would then have 30 days to request a 
hearing on the Agency's determination. The exception, however, would be 
discontinued as of the date specified by EPA in the notice, which may 
include any of the 30-day period and the time required for any 
subsequent hearing process. Thereafter the Agency will decide whether to 
withdraw the exception and will publish a notice in the Federal Register 
stating its decision.
    (7) List of exceptions granted by EPA. The following administrative 
exceptions from the requirements of this section have been granted by 
EPA. Each exception listed in paragraph (e)(7) of this section contains 
a reference to the Federal Register notice in which EPA has granted the 
exception and the effective dates of the exception. The terms and 
conditions of the exception appear in the referenced Federal Register 
notice.
    (i) Exception for hand labor to harvest greenhouse-grown cut roses 
published in the Federal Register of June 10, 1994, effective from June 
10, 1994, to June 10, 1996.
    (ii) Exception to perform irrigation tasks under specified 
conditions published in the Federal Register of May 3, 1995.
    (iii) Exceptions to perform limited contact tasks under specified 
conditions published in the Federal Register of May 3, 1995.
    (iv) Exception for hand labor to harvest greenhouse-grown roses 
under specified conditions published in the Federal Register of October 
3, 1997, effective December 18, 1996 to October 4, 1999.

[57 FR 38151, Aug. 21, 1992, as amended at 59 FR 30264, June 10, 1994; 
60 FR 21954, May 3, 1995; 62 FR 52003, Oct. 3, 1997]



Sec. 170.120  Notice of applications.

    (a) Notification to workers of pesticide applications in 
greenhouses. The agricultural employer shall notify workers of any 
pesticide application in the greenhouse in accordance with this 
paragraph.
    (1) All pesticide applications shall be posted in accordance with 
paragraph (c) of this section.
    (2) If the pesticide product labeling has a statement requiring both 
the posting of treated areas and oral notification to workers, the 
agricultural employer shall also provide oral notification of the 
application to the worker in accordance with paragraph (d) of this 
section.

[[Page 215]]

    (3) Notice need not be given to a worker if the agricultural 
employer can assure that one of the following is met:
    (i) From the start of the application until the end of the 
application and during any restricted-entry interval, the worker will 
not enter, work in, remain in, or pass through the greenhouse; or
    (ii) The worker applied (or supervised the application of) the 
pesticide for which the notice is intended and is aware of all 
information required by paragraphs (d)(1) through (3) of this section.
    (b) Notification to workers on farms, in nurseries, or in forests of 
pesticide applications. The agricultural employer shall notify workers 
of any pesticide application on the farm or in the nursery or forest in 
accordance with this paragraph.
    (1) If the pesticide product labeling has a statement requiring both 
the posting of treated areas and oral notification to workers, the 
agricultural employer shall post signs in accordance with paragraph (c) 
of this section and shall provide oral notification of the application 
to the worker in accordance with paragraph (d) of this section.
    (2) For any pesticide other than those for which the labeling 
requires both posting and oral notification of applications, the 
agricultural employer shall give notice of the application to the worker 
either by the posting of warning signs in accordance with paragraph (c) 
of this section or orally in accordance with paragraph (d) of this 
section, and shall inform the workers as to which method of notification 
is in effect.
    (3) Notice need not be given to a worker if the agricultural 
employer can assure that one of the following is met:
    (i) From the start of the application until the end of the 
application and during any restricted-entry interval, the worker will 
not enter, work in, remain in, or pass through on foot the treated area 
or any area within 1/4 mile of the treated area; or
    (ii) The worker applied (or supervised the application of) the 
pesticide for which the notice is intended and is aware of all 
information required by (d)(1) through (3) of this section.
    (c) Posted warning signs. The agricultural employer shall post 
warning signs in accordance with the following criteria:
    (1) The warning sign shall have a background color that contrasts 
with red. The words ``DANGER'' and ``PELIGRO,'' plus ``PESTICIDES'' and 
``PESTICIDAS,'' shall be at the top of the sign, and the words ``KEEP 
OUT'' and ``NO ENTRE'' shall be at the bottom of the sign. Letters for 
all words must be clearly legible. A circle containing an upraised hand 
on the left and a stern face on the right must be near the center of the 
sign. The inside of the circle must be red, except that the hand and a 
large portion of the face must be in a shade that contrasts with red. 
The length of the hand must be at least twice the height of the smallest 
letters. The length of the face must be only slightly smaller than the 
hand. Additional information such as the name of the pesticide and the 
date of application may appear on the warning sign if it does not 
detract from the appearance of the sign or change the meaning of the 
required information. A black-and-white example of a warning sign 
meeting these requirements, other than the size requirements, follows:

[[Page 216]]

[GRAPHIC] [TIFF OMITTED] TC01MY92.111

    (2) The standard sign shall be at least 14 inches by 16 inches with 
letters at least 1 inch in height. Farms and forests shall use the 
standard size sign unless a smaller sign is necessary because the 
treated area is too small to accommodate a sign of this size. In 
nurseries and greenhouses, the agricultural employer may, at any time, 
use a sign smaller than the standard size sign. Whenever a small sign is 
used on any establishment, there are specific posting distances 
depending on the size of the lettering and symbol on the sign. If a sign 
is used with DANGER and PELIGRO in letters at least \7/8\ inch in height 
and the remaining letters at least \1/2\ inch in height and a red circle

[[Page 217]]

at least 3 inches in diameter containing an upraised hand and a stern 
face, the signs shall be no further than 50 feet apart. If a sign is 
used with DANGER and PELIGRO in letters at least \7/16\ inch in height 
and the remaining letters at least \1/4\ inch in height and a red circle 
at least 1\1/2\ inches in diameter containing an upraised hand and a 
stern face, the signs shall be no further than 25 feet apart. A sign 
with DANGER and PELIGRO in letters less than \7/16\ inch in height or 
with any words in letters less than \1/4\ inch in height or a red circle 
smaller than 1\1/2\ inches in diameter containing an upraised hand and a 
stern face will not satisfy the requirements of the rule. All signs must 
meet the requirements of paragraph (c)(1) of this section.
    (3) The employer may replace the Spanish portion of the warning sign 
with a non-English language read by the largest group of workers who do 
not read English. The replacement sign must be in the same format as the 
original sign and be visible and legible.
    (4) On farms and in forests and nurseries, the signs shall be 
visible from all usual points of worker entry to the treated area, 
including at least each access road, each border with any labor camp 
adjacent to the treated area, and each footpath and other walking route 
that enters the treated area. When there are no usual points of worker 
entry, signs shall be posted in the corners of the treated area or in 
any other location affording maximum visibility.
    (5) In greenhouses, the signs shall be posted so they are visible 
from all usual points of worker entry to the treated area including each 
aisle or other walking route that enters the treated area. When there 
are no usual points of worker entry to the treated area, signs shall be 
posted in the corners of the treated area or in any other location 
affording maximum visibility.
    (6) The signs shall:
    (i) Be posted no sooner than 24 hours before the scheduled 
application of the pesticide.
    (ii) Remain posted throughout the application and any restricted-
entry interval.
    (iii) Be removed within 3 days after the end of the application and 
any restricted-entry interval and before agricultural-worker entry is 
permitted, other than entry permitted by Sec. 170.112.
    (7) The signs shall remain visible and legible during the time they 
are posted.
    (8) When several contiguous areas are to be treated with pesticides 
on a rotating or sequential basis, the entire area may be posted. Worker 
entry, other than entry permitted by Sec. 170.112, is prohibited for the 
entire area while the signs are posted.
    (d) Oral warnings. The agricultural employer shall provide oral 
warnings to workers in a manner that the worker can understand. If a 
worker will be on the premises during the application, the warning shall 
be given before the application takes place. Otherwise, the warning 
shall be given at the beginning of the worker's first work period during 
which the application is taking place or the restricted-entry interval 
for the pesticide is in effect. The warning shall consist of:
    (1) The location and description of the treated area.
    (2) The time during which entry is restricted.
    (3) Instructions not to enter the treated area until the restricted-
entry interval has expired.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33207, June 26, 1996]



Sec. 170.122  Providing specific information about applications.

    When workers are on an agricultural establishment and, within the 
last 30 days, a pesticide covered by this subpart has been applied on 
the establishment or a restricted-entry interval has been in effect, the 
agricultural employer shall display, in accordance with this section, 
specific information about the pesticide.
    (a) Location, accessibility, and legibility. The information shall 
be displayed in the location specified for the pesticide safety poster 
in Sec. 170.135(d) and shall be accessible and legible, as specified in 
Sec. 170.135 (e) and (f).
    (b) Timing. (1) If warning signs are posted for the treated area 
before an application, the specific application information for that 
application shall be posted at the same time or earlier.
    (2) The information shall be posted before the application takes 
place, if workers will be on the establishment

[[Page 218]]

during application. Otherwise, the information shall be posted at the 
beginning of any worker's first work period.
    (3) The information shall continue to be displayed for at least 30 
days after the end of the restricted-entry interval (or, if there is no 
restricted-entry interval, for at least 30 days after the end of the 
application) or at least until workers are no longer on the 
establishment, whichever is earlier.
    (c) Required information. The information shall include:
    (1) The location and description of the treated area.
    (2) The product name, EPA registration number, and active 
ingredient(s) of the pesticide.
    (3) The time and date the pesticide is to be applied.
    (4) The restricted-entry interval for the pesticide.



Sec. 170.124  Notice of applications to handler employers.

    Whenever handlers who are employed by a commercial pesticide 
handling establishment will be performing pesticide handling tasks on an 
agricultural establishment, the agricultural employer shall provide to 
the handler employer, or assure that the handler employer is aware of, 
the following information concerning any areas on the agricultural 
establishment that the handler may be in (or may walk within 1/4 mile 
of) and that may be treated with a pesticide or that may be under a 
restricted-entry interval while the handler will be on the agricultural 
establishment:
    (a) Specific location and description of any such areas; and
    (b) Restrictions on entering those areas.



Sec. 170.130  Pesticide safety training for workers.

    (a) General requirement--(1) Agricultural employer assurance. The 
agricultural employer shall assure that each worker, required by this 
section to be trained, has been trained according to this section during 
the last 5 years, counting from the end of the month in which the 
training was completed.
    (2) Requirement for workers performing early-entry activities. 
Before a worker enters a treated area on the agricultural establishment 
during a restricted-entry interval to perform early-entry activities 
permitted by Sec. 170.112 and contacts anything that has been treated 
with the pesticide to which the restricted-entry interval applies, 
including but not limited to, soil, water, or surfaces of plants, the 
agricultural employer shall assure that the worker has been trained.
    (3) Requirements for other agricultural workers--(i) Information 
before entry. As of January 1, 1996, and except as provided in paragraph 
(a)(2) of this section, before a worker enters any areas on the 
agricultural establishment where, within the last 30 days a pesticide to 
which this subpart applies has been applied or the restricted-entry 
interval for such pesticide has been in effect, the agricultural 
employer shall assure that the worker has been provided the pesticide 
safety information specified in paragraph (c), in a manner that 
agricultural workers can understand, such as by providing written 
materials or oral communication or by other means. The agricultural 
employer must be able to verify compliance with this requirement.
    (ii) Training before the 6th day of entry. Except as provided in 
paragraph (a)(2) of this section, before the 6th day that a worker 
enters any areas on the agricultural establishment where, within the 
last 30 days a pesticide to which this subpart applies has been applied 
or a restricted-entry interval for such pesticide has been in effect, 
the agricultural employer shall assure that the worker has been trained.
    (iii) Exceptions during interim period. Until December 31, 1995, and 
except as provided by paragraph (a)(2) of this section, before the 16th 
day that a worker enters any areas on the agricultural establishment 
where, within the last 30 days a pesticide to which this subpart applies 
has been applied or a restricted-entry interval has been in effect, the 
agricultural employer shall assure that the worker has been trained. 
After December 31, 1995 this exception no longer applies.
    (b) Exceptions. The following persons need not be trained under this 
section:
    (1) A worker who is currently certified as an applicator of 
restricted-use

[[Page 219]]

pesticides under part 171 of this chapter.
    (2) A worker who satisfies the training requirements of part 171 of 
this chapter.
    (3) A worker who satisfies the handler training requirements of 
Sec. 170.230(c).
    (4) A worker who is certified or licensed as a crop advisor by a 
program acknowledged as appropriate in writing by EPA or a State or 
Tribal lead agency for pesticide enforcement, provided that a 
requirement for such certification or licensing is pesticide safety 
training that includes all the information set out in 
Sec. 170.230(c)(4).
    (c) Pesticide safety information. The pesticide safety information 
required by paragraph (a)(3)(i) shall be presented to workers in a 
manner that the workers can understand. At a minimum, the following 
information shall be provided:
    (1) Pesticides may be on or in plants, soil, irrigation water, or 
drifting from nearby applications.
    (2) Prevent pesticides from entering your body by:
    (i) Following directions and/or signs about keeping out of treated 
or restricted areas.
    (ii) Washing before eating, drinking, using chewing gum or tobacco, 
or using the toilet.
    (iii) Wearing work clothing that protects the body from pesticide 
residues.
    (iv) Washing/showering with soap and water, shampoo hair, and put on 
clean clothes after work.
    (v) Washing work clothes separately from other clothes before 
wearing them again.
    (vi) Washing immediately in the nearest clean water if pesticides 
are spilled or sprayed on the body. As soon as possible, shower, 
shampoo, and change into clean clothes.
    (3) Further training will be provided within 5 days.
    (d) Training programs. (1) General pesticide safety information 
shall be presented to workers either orally from written materials or 
audiovisually. The information must be presented in a manner that the 
workers can understand (such as through a translator) using nontechnical 
terms. The presenter also shall respond to workers' questions.
    (2) The person who conducts the training shall meet at least one of 
the following criteria:
    (i) Be currently certified as an applicator of restricted-use 
pesticides under part 171 of this chapter; or
    (ii) Be currently designated as a trainer of certified applicators 
or pesticide handlers by a State, Federal, or Tribal agency having 
jurisdiction; or
    (iii) Have completed a pesticide safety train-the-trainer program 
approved by a State, Federal, or Tribal agency having jurisdiction; or
    (iv) Satisfy the training requirements in part 171 of this chapter 
or in Sec. 170.230(c).
    (3) Any person who issues an EPA-approved Worker Protection Standard 
worker training certificate must assure that the worker who receives the 
training certificate has been trained in accordance with (c)(4) of this 
section.
    (4) The training materials shall convey, at a minimum, the following 
information:
    (i) Where and in what form pesticides may be encountered during work 
activities.
    (ii) Hazards of pesticides resulting from toxicity and exposure, 
including acute and chronic effects, delayed effects, and sensitization.
    (iii) Routes through which pesticides can enter the body.
    (iv) Signs and symptoms of common types of pesticide poisoning.
    (v) Emergency first aid for pesticide injuries or poisonings.
    (vi) How to obtain emergency medical care.
    (vii) Routine and emergency decontamination procedures, including 
emergency eyeflushing techniques.
    (viii) Hazards from chemigation and drift.
    (ix) Hazards from pesticide residues on clothing.
    (x) Warnings about taking pesticides or pesticide containers home.
    (xi) Requirements of this subpart designed to reduce the risks of 
illness or injury resulting from workers' occupational exposure to 
pesticides, including application and entry restrictions, the design of 
the warning sign, posting of

[[Page 220]]

warning signs, oral warnings, the availability of specific information 
about applications, and the protection against retaliatory acts.
    (e) Verification of training. (1) Except as provided in paragraph 
(e)(2) of this section, if the agricultural employer assures that a 
worker possesses an EPA-approved Worker Protection Standard worker 
training certificate, then the requirements of paragraph (a) and (c) of 
this section will have been met.
    (2) If the agricultural employer is aware or has reason to know that 
an EPA-approved Worker Protection Standard worker training certificate 
has not been issued in accordance with this section, or has not been 
issued to the worker bearing the certificate, or the training was 
completed more than 5 years before the beginning of the current month, a 
worker's possession of that certificate does not meet the requirements 
of paragraph (a) of this section.

[57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21947, 21952, May 3, 
1995]



Sec. 170.135  Posted pesticide safety information.

    (a) Requirement. When workers are on an agricultural establishment 
and, within the last 30 days, a pesticide covered by this subpart has 
been applied on the establishment or a restricted-entry interval has 
been in effect, the agricultural employer shall display, in accordance 
with this section, pesticide safety information.
    (b) Pesticide safety poster. A safety poster must be displayed that 
conveys, at a minimum, the following basic pesticide safety concepts:
    (1) Help keep pesticides from entering your body. At a minimum, the 
following points shall be conveyed:
    (i) Avoid getting on your skin or into your body any pesticides that 
may be on plants and soil, in irrigation water, or drifting from nearby 
applications.
    (ii) Wash before eating, drinking, using chewing gum or tobacco, or 
using the toilet.
    (iii) Wear work clothing that protects the body from pesticide 
residues (long-sleeved shirts, long pants, shoes and socks, and a hat or 
scarf).
    (iv) Wash/shower with soap and water, shampoo hair, and put on clean 
clothes after work.
    (v) Wash work clothes separately from other clothes before wearing 
them again.
    (vi) Wash immediately in the nearest clean water if pesticides are 
spilled or sprayed on the body. As soon as possible, shower, shampoo, 
and change into clean clothes.
    (vii) Follow directions about keeping out of treated or restricted 
areas.
    (2) There are Federal rules to protect workers and handlers, 
including a requirement for safety training.
    (c) Emergency medical care information. (1) The name, address, and 
telephone number of the nearest emergency medical care facility shall be 
on the safety poster or displayed close to the safety poster.
    (2) The agricultural employer shall inform workers promptly of any 
change to the information on emergency medical care facilities.
    (d) Location. (1) The information shall be displayed in a central 
location on the farm or in the nursery or greenhouse where it can be 
readily seen and read by workers.
    (2) The information shall be displayed in a location in or near the 
forest in a place where it can be readily seen and read by workers and 
where workers are likely to congregate or pass by, such as at a 
decontamination site or an equipment storage site.
    (e) Accessibility. Workers shall be informed of the location of the 
information and shall be allowed access to it.
    (f) Legibility. The information shall remain legible during the time 
it is posted.



Sec. 170.150  Decontamination.

    (a)(1) Requirement. The agricultural employer must provide 
decontamination supplies for workers in accordance with this section 
whenever:
    (i) Any worker on the agricultural establishment is performing an 
activity in the area where a pesticide was applied or a restricted-entry 
interval (REI) was in effect within the last 30 days, and;
    (ii) The worker contacts anything that has been treated with the 
pesticide, including, but not limited to

[[Page 221]]

soil, water, plants, plant surfaces, and plant parts.
    (2) Exception. The 30-day time period established in paragraph 
(a)(1)(i) of this section shall not apply if the only pesticides used in 
the treated area are products with an REI of 4 hours or less on the 
label (but not a product without an REI on the label). When workers are 
in such treated areas, the agricultural employer shall provide 
decontamination supplies for not less than 7 days following the 
expiration of any applicable REI.
    (b) General conditions. (1) The agricultural employer shall provide 
workers with enough water for routine washing and emergency eyeflushing. 
At all times when the water is available to workers, the employer shall 
assure that it is of a quality and temperature that will not cause 
illness or injury when it contacts the skin or eyes or if it is 
swallowed.
    (2) When water stored in a tank is to be used for mixing pesticides, 
it shall not be used for decontamination or eyeflushing, unless the tank 
is equipped with properly functioning valves or other mechanisms that 
prevent movement of pesticides into the tank.
    (3) The agricultural employer shall provide soap and single-use 
towels in quantities sufficient to meet worker's needs.
    (4) To provide for emergency eyeflushing, the agricultural employer 
shall assure that at least 1 pint of water is immediately available to 
each worker who is performing early-entry activities permitted by 
Sec. 170.112 and for which the pesticide labeling requires protective 
eyewear. The eyeflush water shall be carried by the early-entry worker, 
or shall be on the vehicle the early-entry worker is using, or shall be 
otherwise immediately accessible.
    (c) Location. (1) The decontamination supplies shall be located 
together and be reasonably accessible to and not more than 1/4 mile from 
where workers are working.
    (2) For worker activities performed more than 1/4 mile from the 
nearest place of vehicular access:
    (i) The soap, single-use towels, and water may be at the nearest 
place of vehicular access.
    (ii) The agricultural employer may permit workers to use clean water 
from springs, streams, lakes, or other sources for decontamination at 
the remote work site, if such water is more accessible than the water 
located at the nearest place of vehicular access.
    (3) The decontamination supplies shall not be maintained in an area 
being treated with pesticides.
    (4) The decontamination supplies shall not be maintained in an area 
that is under a restricted-entry interval, unless the workers for whom 
the supplies are provided are performing early-entry activities 
permitted by Sec. 170.112 and involving contact with treated surfaces 
and the decontamination supplies would otherwise not be reasonably 
accessible to those workers.
    (d) Decontamination after early-entry activities. At the end of any 
exposure period for workers engaged in early-entry activities permitted 
by Sec. 170.112 and involving contact with anything that has been 
treated with the pesticide to which the restricted-entry interval 
applies, including, but not limited to, soil, water, air, or surfaces of 
plants, the agricultural employer shall provide, at the site where the 
workers remove personal protective equipment, soap, clean towels, and a 
sufficient amount of water so that the workers may wash thoroughly.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33212, June 26, 1996]



Sec. 170.160  Emergency assistance.

    If there is reason to believe that a person who is or has been 
employed on an agricultural establishment to perform tasks related to 
the production of agricultural plants has been poisoned or injured by 
exposure to pesticides used on the agricultural establishment, 
including, but not limited to, exposures from application, splash, 
spill, drift, or pesticide residues, the agricultural employer shall:
    (a) Make available to that person prompt transportation from the 
agricultural establishment, including any labor camp on the agricultural 
establishment, to an appropriate emergency medical facility.
    (b) Provide to that person or to treating medical personnel, 
promptly upon

[[Page 222]]

request, any obtainable information on:
    (1) Product name, EPA registration number, and active ingredients of 
any product to which that person might have been exposed.
    (2) Antidote, first aid, and other medical information from the 
product labeling.
    (3) The circumstances of application or use of the pesticide on the 
agricultural establishment.
    (4) The circumstances of exposure of that person to the pesticide.



               Subpart C--Standard for Pesticide Handlers



Sec. 170.202  Applicability of this subpart.

    Except as provided by Secs. 170.203 and 170.204, this subpart 
applies when any pesticide is handled for use on an agricultural 
establishment.

[60 FR 21952, May 3, 1995]



Sec. 170.203  Exceptions.

    Exceptions. This subpart does not apply when any pesticide is 
handled for use on an agricultural establishment in the following 
circumstances:
    (a) For mosquito abatement, Mediterranean fruit fly eradication, or 
similar wide-area public pest control programs sponsored by governmental 
entities.
    (b) On livestock or other animals, or in or about animal premises.
    (c) On plants grown for other than commercial or research purposes, 
which may include plants in habitations, home fruit and vegetable 
gardens, and home greenhouses.
    (d) On plants that are in ornamental gardens, parks, and public or 
private lawns and grounds and that are intended only for aesthetic 
purposes or climatic modification.
    (e) In a manner not directly related to the production of 
agricultural plants, including, but not limited to, structural pest 
control, control of vegetation along rights-of-way and in other noncrop 
areas, and pasture and rangeland use.
    (f) For control of vertebrate pests.
    (g) As attractants or repellents in traps.
    (h) On the harvested portions of agricultural plants or on harvested 
timber.
    (i) For research uses of unregistered pesticides.

[57 FR 38151, Aug. 21, 1992. Redesignated at 60 FR 21952, May 3, 1995]



Sec. 170.204  Exemptions.

    The handlers listed in this section are exempt from the specified 
provisions of this subpart.
    (a) Owners of agricultural establishments. (1) The owner of an 
agricultural establishment is not required to provide to himself or 
members of his immediate family who are performing handling tasks on 
their own agricultural establishment the protections of:
    (i) Section 170.210(b) and (c).
    (ii) Section 170.222.
    (iii) Section 170.230.
    (iv) Section 170.232.
    (v) Section 170.234.
    (vi) Section 170.235.
    (vii) Section 170.240(e) through (g).
    (viii) Section 170.250.
    (ix) Section 170.260.
    (2) The owner of the agricultural establishment must provide the 
protections listed in paragraphs (a)(1) (i) through (ix) of this section 
to other handlers and other persons who are not members of his immediate 
family.
    (b) Crop advisors. (1) Provided that the conditions of paragraph 
(b)(2) of this section are met, a person who is certified or licensed as 
a crop advisor by a program acknowledged as appropriate in writing by 
EPA or a State or Tribal lead agency for pesticide enforcement, and 
persons performing crop advising tasks under such qualified crop 
advisor's direct supervision, are exempt from the provisions of:
    (i) Section 170.232.
    (ii) Section 170.240.
    (iii) Section 170.250.
    (iv) Section 170.260.

A person is under the direct supervision of a crop advisor when the crop 
advisor exerts the supervisory controls set out in paragraphs (b)(2)(iv) 
and (v) of this section. Direct supervision does not require that the 
crop advisor be physically present at all times, but the crop advisor 
must be readily accessible to the employees at all times.

[[Page 223]]

    (2) Conditions of exemption. (i) The certification or licensing 
program requires pesticide safety training that includes, at least, all 
the information in Sec. 170.230(c)(4).
    (ii) No entry into the treated area occurs until after application 
ends.
    (iii) Applies only when performing crop advising tasks in the 
treated area.
    (iv) The crop advisor must make specific determinations regarding 
the appropriate PPE, appropriate decontamination supplies, and how to 
conduct the tasks safely. The crop advisor must convey this information 
to each person under his direct supervision in a language that the 
person understands.
    (v) Before entering a treated area, the certified or licensed crop 
advisor must inform, through an established practice of communication, 
each person under his direct supervision of the pesticide products and 
active ingredient(s) applied, method of application, time of 
application, the restricted entry interval, which tasks to undertake, 
and how to contact the crop advisor.
    (c) Grace period for persons performing crop advisor tasks who are 
not certified or licensed. (1) Provided that the conditions of paragraph 
(c)(2) of this section are met, a person who is neither certified nor 
licensed as a crop advisor and any person performing crop advising tasks 
under his direct supervision is exempt until May 1, 1996, from the 
requirements of:
    (i) Section 170.230.
    (ii) Section 170.232.
    (iii) Section 170.240.
    (iv) Section 170.250.
    (v) Section 170.260.
    (2) Conditions of exemption. (i) No entry into the treated area 
occurs until after application ends.
    (ii) Applies only when the persons are performing crop advising 
tasks in the treated area.
    (iii) The crop advisor must make specific determinations regarding 
the appropriate PPE, appropriate decontamination supplies, and how to 
conduct the tasks safely. The crop advisor must convey this information 
to each person under his direct supervision in a language that the 
person understands.
    (iv) Before entering a treated area, the crop advisor must inform, 
through an established practice of communication, each person under his 
direct supervision of the pesticide products and active ingredient(s) 
applied, method of application, time of application, the restricted 
entry interval, which tasks to undertake, and how to contact the crop 
advisor.

[60 FR 21953, May 3, 1995]



Sec. 170.210  Restrictions during applications.

    (a) Contact with workers and other persons. The handler employer and 
the handler shall assure that no pesticide is applied so as to contact, 
either directly or through drift, any worker or other person, other than 
an appropriately trained and equipped handler.
    (b) Handlers handling highly toxic pesticides. The handler employer 
shall assure that any handler who is performing any handling activity 
with a product that has the skull and crossbones symbol on the front 
panel of the label is monitored visually or by voice communication at 
least every 2 hours.
    (c) Fumigant applications in greenhouses. The handler employer shall 
assure:
    (1) That any handler who handles a fumigant in a greenhouse, 
including a handler who enters the greenhouse before the acceptable 
inhalation exposure level or ventilation criteria have been met to 
monitor air levels or to initiate ventilation, maintains continuous 
visual or voice contact with another handler.
    (2) That the other handler has immediate access to the personal 
protective equipment required by the fumigant labeling for handlers in 
the event entry into the fumigated greenhouse becomes necessary for 
rescue.



Sec. 170.222  Providing specific information about applications.

    When handlers (except those employed by a commercial pesticide 
handling establishment) are on an agricultural establishment and, within 
the last 30 days, a pesticide covered by this subpart has been applied 
on the establishment or a restricted-entry interval has been in effect, 
the handler employer shall display, in accordance with this section, 
specific information about the pesticide.

[[Page 224]]

    (a) Location, accessibility, and legibility. The information shall 
be displayed in the same location specified for the pesticide safety 
poster in Sec. 170.235(d) of this part and shall be accessible and 
legible, as specified in Sec. 170.235(e) and (f) of this part.
    (b) Timing. (1) If warning signs are posted for the treated area 
before an application, the specific application information for that 
application shall be posted at the same time or earlier.
    (2) The information shall be posted before the application takes 
place, if handlers (except those employed by a commercial pesticide 
handling establishment) will be on the establishment during application. 
Otherwise, the information shall be posted at the beginning of any such 
handler's first work period.
    (3) The information shall continue to be displayed for at least 30 
days after the end of the restricted-entry interval (or, if there is no 
restricted-entry interval, for at least 30 days after the end of the 
application) or at least until the handlers are no longer on the 
establishment, whichever is earlier.
    (c) Required information. The information shall include:
    (1) The location and description of the treated area.
    (2) The product name, EPA registration number, and active 
ingredient(s) of the pesticide.
    (3) The time and date the pesticide is to be applied.
    (4) The restricted-entry interval for the pesticide.



Sec. 170.224  Notice of applications to agricultural employers.

    Before the application of any pesticide on or in an agricultural 
establishment, the handler employer shall provide the following 
information to any agricultural employer for the establishment or shall 
assure that any agricultural employer is aware of:
    (a) Specific location and description of the treated area.
    (b) Time and date of application.
    (c) Product name, EPA registration number, and active ingredient(s).
    (d) Restricted-entry interval.
    (e) Whether posting and oral notification are required.
    (f) Any other product-specific requirements on the product labeling 
concerning protection of workers or other persons during or after 
application.



Sec. 170.230  Pesticide safety training for handlers.

    (a) Requirement. Before any handler performs any handling task, the 
handler employer shall assure that the handler has been trained in 
accordance with this section during the last 5 years, counting from the 
end of the month in which the training was completed.
    (b) Exceptions. The following persons need not be trained under this 
section:
    (1) A handler who is currently certified as an applicator of 
restricted-use pesticides under part 171 of this chapter.
    (2) A handler who satisfies the training requirements of part 171 of 
this chapter.
    (3) A handler who is certified or licensed as a crop advisor by a 
program acknowledged as appropriate in writing by EPA or a State or 
Tribal lead agency for pesticide enforcement, provided that a 
requirement for such certification or licensing is pesticide safety 
training that includes all the information set out in 
Sec. 170.230(c)(4).
    (c) Training programs. (1) General pesticide safety information 
shall be presented to handlers either orally from written materials or 
audiovisually. The information must be presented in a manner that the 
handlers can understand (such as through a translator). The presenter 
also shall respond to handlers' questions.
    (2) The person who conducts the training shall meet at least one of 
the following criteria:
    (i) Be currently certified as an applicator of restricted-use 
pesticides under part 171 of this chapter; or
    (ii) Be currently designated as a trainer of certified applicators 
or pesticide handlers by a State, Federal, or Tribal agency having 
jurisdiction; or
    (iii) Have completed a pesticide safety train-the-trainer program 
approved by a State, Federal, or Tribal agency having jurisdiction.
    (3) Any person who issues an EPA-approved Worker Protection Standard

[[Page 225]]

handler training certificate must assure that the handler who receives 
the training certificate has been trained in accordance with paragraph 
(c)(4) of this section.
    (4) The pesticide safety training materials must convey, at a 
minimum, the following information:
    (i) Format and meaning of information contained on pesticide labels 
and in labeling, including safety information such as precautionary 
statements about human health hazards.
    (ii) Hazards of pesticides resulting from toxicity and exposure, 
including acute and chronic effects, delayed effects, and sensitization.
    (iii) Routes by which pesticides can enter the body.
    (iv) Signs and symptoms of common types of pesticide poisoning.
    (v) Emergency first aid for pesticide injuries or poisonings.
    (vi) How to obtain emergency medical care.
    (vii) Routine and emergency decontamination procedures.
    (viii) Need for and appropriate use of personal protective 
equipment.
    (ix) Prevention, recognition, and first aid treatment of heat-
related illness.
    (x) Safety requirements for handling, transporting, storing, and 
disposing of pesticides, including general procedures for spill cleanup.
    (xi) Environmental concerns such as drift, runoff, and wildlife 
hazards.
    (xii) Warnings about taking pesticides or pesticide containers home.
    (xiii) Requirements of this subpart that must be followed by handler 
employers for the protection of handlers and other persons, including 
the prohibition against applying pesticides in a manner that will cause 
contact with workers or other persons, the requirement to use personal 
protective equipment, the provisions for training and decontamination, 
and the protection against retaliatory acts.
    (d) Verification of training. (1) Except as provided in paragraph 
(d)(2) of this section, if the handler employer assures that a handler 
possesses an EPA-approved Worker Protection Standard handler training 
certificate, then the requirements of paragraph (a) of this section will 
have been met.
    (2) If the handler employer is aware or has reason to know that an 
EPA-approved Worker Protection Standard handler training certificate has 
not been issued in accordance with this section, or has not been issued 
to the handler bearing the certificate, or the handler training was 
completed more than 5 years before the beginning of the current month, a 
handler's possession of that certificate does not meet the requirements 
of paragraph (a) of this section.

[57 FR 38151, Aug. 21, 1992, as amended at 60 FR 21953, May 3, 1995]



Sec. 170.232  Knowledge of labeling and site-specific information.

    (a) Knowledge of labeling information. (1) The handler employer 
shall assure that before the handler performs any handling activity, the 
handler either has read the product labeling or has been informed in a 
manner the handler can understand of all labeling requirements related 
to safe use of the pesticide, such as signal words, human hazard 
precautions, personal protective equipment requirements, first aid 
instructions, environmental precautions, and any additional precautions 
pertaining to the handling activity to be performed.
    (2) The handler employer shall assure that the handler has access to 
the product labeling information during handling activities.
    (b) Knowledge of site-specific information. Whenever a handler who 
is employed by a commercial pesticide handling establishment will be 
performing pesticide handling tasks on an agricultural establishment, 
the handler employer shall assure that the handler is aware of the 
following information concerning any areas on the agricultural 
establishment that the handler may be in (or may walk within 1/4 mile 
of) and that may be treated with a pesticide or that may be under a 
restricted-entry interval while the handler will be on the agricultural 
establishment:
    (1) Specific location and description of any such areas; and
    (2) Restrictions on entering those areas.

[[Page 226]]



Sec. 170.234  Safe operation of equipment.

    (a) The handler employer shall assure that before the handler uses 
any equipment for mixing, loading, transferring, or applying pesticides, 
the handler is instructed in the safe operation of such equipment, 
including, when relevant, chemigation safety requirements and drift 
avoidance.
    (b) The handler employer shall assure that, before each day of use, 
equipment used for mixing, loading, transferring, or applying pesticides 
is inspected for leaks, clogging, and worn or damaged parts, and any 
damaged equipment is repaired or is replaced.
    (c) Before allowing any person to repair, clean, or adjust equipment 
that has been used to mix, load, transfer, or apply pesticides, the 
handler employer shall assure that pesticide residues have been removed 
from the equipment, unless the person doing the cleaning, repairing, or 
adjusting is a handler employed by the agricultural or commercial 
pesticide handling establishment. If pesticide residue removal is not 
feasible, the handler employer shall assure that the person who repairs, 
cleans, or adjusts such equipment is informed:
    (1) That such equipment may be contaminated with pesticides.
    (2) Of the potentially harmful effects of exposure to pesticides.
    (3) Of the correct way to handle such equipment.



Sec. 170.235  Posted pesticide safety information.

    (a) Requirement. When handlers (except those employed by a 
commercial pesticide handling establishment) are on an agricultural 
establishment and, within the last 30 days, a pesticide covered by this 
subpart has been applied on the establishment or a restricted-entry 
interval has been in effect, the handler employer shall display, in 
accordance with this section, pesticide safety information.
    (b) Pesticide safety poster. A safety poster must be displayed that 
conveys, at a minimum, the following basic pesticide safety concepts:
    (1) Help keep pesticides from entering your body. At a minimum, the 
following points shall be conveyed:
    (i) Avoid getting on your skin or into your body any pesticides that 
may be on plants and soil, in irrigation water, or drifting from nearby 
applications.
    (ii) Wash before eating, drinking, using chewing gum or tobacco, or 
using the toilet.
    (iii) Wear work clothing that protects the body from pesticide 
residues (long-sleeved shirts, long pants, shoes and socks, and a hat or 
scarf).
    (iv) Wash/shower with soap and water, shampoo hair, and put on clean 
clothes after work.
    (v) Wash work clothes separately from other clothes before wearing 
them again.
    (vi) Wash immediately in the nearest clean water if pesticides are 
spilled or sprayed on the body. As soon as possible, shower, shampoo, 
and change into clean clothes.
    (vii) Follow directions about keeping out of treated or restricted 
areas.
    (2) There are Federal rules to protect workers and handlers 
including a requirement for safety training.
    (c) Emergency medical care information. (1) The name, address, and 
telephone number of the nearest emergency medical care facility shall be 
on the safety poster or displayed close to the safety poster.
    (2) The handler employer shall inform handlers promptly of any 
change to the information on emergency medical care facilities.
    (d) Location. (1) The information shall be displayed in a central 
location on the farm or in the nursery or greenhouse where it can be 
readily seen and read by handlers.
    (2) The information shall be displayed in a location in or near the 
forest in a place where it can be readily seen and read by handlers and 
where handlers are likely to congregate or pass by, such as at a 
decontamination site or an equipment storage site.
    (e) Accessibility. Handlers shall be informed of the location of the 
information and shall be allowed access to it.
    (f) Legibility. The information shall remain legible during the time 
it is posted.

[[Page 227]]



Sec. 170.240  Personal protective equipment.

    (a) Requirement. Any person who performs tasks as a pesticide 
handler shall use the clothing and personal protective equipment 
specified on the labeling for use of the product.
    (b) Definition. (1) Personal protective equipment (PPE) means 
devices and apparel that are worn to protect the body from contact with 
pesticides or pesticide residues, including, but not limited to, 
coveralls, chemical-resistant suits, chemical-resistant gloves, 
chemical-resistant footwear, respiratory protection devices, chemical-
resistant aprons, chemical-resistant headgear, and protective eyewear.
    (2) Long-sleeved shirts, short-sleeved shirts, long pants, short 
pants, shoes, socks, and other items of work clothing are not considered 
personal protective equipment for the purposes of this section and are 
not subject to the requirements of this section, although pesticide 
labeling may require that such work clothing be worn during some 
activities.
    (c) Provision. When personal protective equipment is specified by 
the labeling of any pesticide for any handling activity, the handler 
employer shall provide the appropriate personal protective equipment in 
clean and operating condition to the handler.
    (1) When ``chemical-resistant'' personal protective equipment is 
specified by the product labeling, it shall be made of material that 
allows no measurable movement of the pesticide being used through the 
material during use.
    (2) When ``waterproof'' personal protective equipment is specified 
by the product labeling, it shall be made of material that allows no 
measurable movement of water or aqueous solutions through the material 
during use.
    (3) When a ``chemical-resistant suit'' is specified by the product 
labeling, it shall be a loose-fitting, one- or two-piece chemical-
resistant garment that covers, at a minimum, the entire body except 
head, hands, and feet.
    (4) When ``coveralls'' are specified by the product labeling, they 
shall be a loose-fitting, one- or two-piece garment, such as a cotton or 
cotton and polyester coverall, that covers, at a minimum, the entire 
body except head, hands, and feet. The pesticide product labeling may 
specify that the coveralls be worn over another layer of clothing.
    (5) Gloves shall be of the type specified by the product labeling. 
Gloves or glove linings made of leather, cotton, or other absorbent 
material shall not be worn for handling activities unless such materials 
are listed on the product labeling as acceptable for such use.
    (6) When ``chemical-resistant footwear'' is specified by the product 
labeling, one of the following types of footwear must be worn:
    (i) Chemical-resistant shoes.
    (ii) Chemical-resistant boots.
    (iii) Chemical-resistant shoe coverings worn over shoes or boots.
    (7) When ``protective eyewear'' is specified by the product 
labeling, one of the following types of eyewear must be worn:
    (i) Goggles.
    (ii) Face shield.
    (iii) Safety glasses with front, brow, and temple protection.
    (iv) Full-face respirator.
    (8) When a ``chemical-resistant apron'' is specified by the product 
labeling, an apron that covers the front of the body from mid-chest to 
the knees shall be worn.
    (9) When a respirator is specified by the product labeling, it shall 
be appropriate for the pesticide product used and for the activity to be 
performed. The handler employer shall assure that the respirator fits 
correctly.
    (10) When ``chemical-resistant headgear'' is specified by the 
product labeling, it shall be either a chemical resistant hood or a 
chemical-resistant hat with a wide brim.
    (d) Exceptions to personal protective equipment specified on product 
labeling--(1) Body protection. (i) A chemical-resistant suit may be 
substituted for ``coveralls,'' and any requirement for an additional 
layer of clothing beneath is waived.
    (ii) A chemical-resistant suit may be substituted for ``coveralls'' 
and a chemical-resistant apron.
    (2) Boots. If chemical-resistant footwear with sufficient durability 
and a tread appropriate for wear in rough terrain is not obtainable, 
then leather boots may be worn in such terrain.

[[Page 228]]

    (3) Gloves. If chemical-resistant gloves with sufficient durability 
and suppleness are not obtainable, then during handling activities with 
roses or other plants with sharp thorns, leather gloves may be worn over 
chemical-resistant glove liners. However, once leather gloves are worn 
for this use, thereafter they shall be worn only with chemical-resistant 
liners and they shall not be worn for any other use.
    (4) Closed systems. If handling tasks are performed using properly 
functioning systems that enclose the pesticide to prevent it from 
contacting handlers or other persons, and if such systems are used and 
are maintained in accordance with that manufacturer's written operating 
instructions, exceptions to labeling-specified personal protective 
equipment for the handling activity are permitted as provided in 
paragraphs (d)(4)(i) and (ii) of this section.
    (i) Persons using a closed system to mix or load pesticides with a 
signal word of DANGER or WARNING may substitute a long-sleeved shirt, 
long pants, shoes, socks, chemical-resistant apron, and any protective 
gloves specified on the labeling for handlers for the labeling-specified 
personal protective equipment.
    (ii) Persons using a closed system to mix or load pesticides other 
than those in paragraph (d)(4)(i) of this section or to perform other 
handling tasks may substitute a long-sleeved shirt, long pants, shoes, 
and socks for the labeling-specified personal protective equipment.
    (iii) Persons using a closed system that operates under pressure 
shall wear protective eyewear.
    (iv) Persons using a closed system shall have all labeling-specified 
personal protective equipment immediately available for use in an 
emergency.
    (5) Enclosed cabs. If handling tasks are performed from inside a cab 
that has a nonporous barrier which totally surrounds the occupants of 
the cab and prevents contact with pesticides outside of the cab, 
exceptions to personal protective equipment specified on the product 
labeling for that handling activity are permitted as provided in 
paragraphs (d)(5) (i) through (iv) of this section.
    (i) Persons occupying an enclosed cab may substitute a long-sleeved 
shirt, long pants, shoes, and socks for the labeling-specified personal 
protective equipment. If a respiratory protection device is specified on 
the pesticide product labeling for the handling activity, it must be 
worn.
    (ii) Persons occupying an enclosed cab that has a properly 
functioning ventilation system which is used and maintained in 
accordance with the manufacturer's written operating instructions and 
which is declared in writing by the manufacturer or by a governmental 
agency to provide respiratory protection equivalent to or greater than a 
dust/mist filtering respirator may substitute a long-sleeved shirt, long 
pants, shoes, and socks for the labeling-specified personal protective 
equipment. If a respiratory protection device other than a dust/mist-
filtering respirator is specified on the pesticide product labeling, it 
must be worn.
    (iii) Persons occupying an enclosed cab that has a properly 
functioning ventilation system which is used and maintained in 
accordance with the manufacturer's written operating instructions and 
which is declared in writing by the manufacturer or by a governmental 
agency to provide respiratory protection equivalent to or greater than 
the vapor- or gas-removing respirator specified on pesticide product 
labeling may substitute a long-sleeved shirt, long pants, shoes, and 
socks for the labeling-specified personal protective equipment. If an 
air-supplying respirator or a self-contained breathing apparatus (SCBA) 
is specified on the pesticide product labeling, it must be worn.
    (iv) Persons occupying an enclosed cab shall have all labeling-
specified personal protective equipment immediately available and stored 
in a chemical-resistant container, such as a plastic bag. They shall 
wear such personal protective equipment if it is necessary to exit the 
cab and contact pesticide-treated surfaces in the treated area. Once 
personal protective equipment is worn in the treated area, it must be 
removed before reentering the cab.

[[Page 229]]

    (6) Aerial applications--(i) Use of gloves. Chemical-resistant 
gloves shall be worn when entering or leaving an aircraft contaminated 
by pesticide residues. In the cockpit, the gloves shall be kept in an 
enclosed container to prevent contamination of the inside of the 
cockpit.
    (ii) Open cockpit. Persons occupying an open cockpit shall use the 
personal protective equipment specified in the product labeling for use 
during application, except that chemical-resistant footwear need not be 
worn. A helmet may be substituted for chemical-resistant headgear. A 
visor may be substituted for protective eyewear.
    (iii) Enclosed cockpit. Persons occupying an enclosed cockpit may 
substitute a long-sleeved shirt, long pants, shoes, and socks for 
labeling-specified personal protective equipment.
    (7) Crop advisors. Crop advisors entering treated areas while a 
restricted-entry interval is in effect may wear the personal protective 
equipment specified on the pesticide labeling for early-entry activities 
instead of the personal protective equipment specified on the pesticide 
labeling for handling activities, provided:
    (i) Application has been completed for at least 4 hours.
    (ii) Any inhalation exposure level listed in the labeling has been 
reached or any ventilation criteria established by Sec. 170.110(c)(3) or 
in the labeling have been met.
    (e) Use of personal protective equipment. (1) The handler employer 
shall assure that personal protective equipment is used correctly for 
its intended purpose and is used according to the manufacturer's 
instructions.
    (2) The handler employer shall assure that, before each day of use, 
all personal protective equipment is inspected for leaks, holes, tears, 
or worn places, and any damaged equipment is repaired or discarded.
    (f) Cleaning and maintenance. (1) The handler employer shall assure 
that all personal protective equipment is cleaned according to the 
manufacturer's instructions or pesticide product labeling instructions 
before each day of reuse. In the absence of any such instructions, it 
shall be washed thoroughly in detergent and hot water.
    (2) If any personal protective equipment cannot be cleaned properly, 
the handler employer shall dispose of the personal protective equipment 
in accordance with any applicable Federal, State, and local regulations. 
Coveralls or other absorbent materials that have been drenched or 
heavily contaminated with an undiluted pesticide that has the signal 
word DANGER or WARNING on the label shall be not be reused.
    (3) The handler employer shall assure that contaminated personal 
protective equipment is kept separately and washed separately from any 
other clothing or laundry.
    (4) The handler employer shall assure that all clean personal 
protective equipment shall be either dried thoroughly before being 
stored or shall be put in a well ventilated place to dry.
    (5) The handler employer shall assure that all personal protective 
equipment is stored separately from personal clothing and apart from 
pesticide-contaminated areas.
    (6) The handler employer shall assure that when dust/mist filtering 
respirators are used, the filters shall be replaced:
    (i) When breathing resistance becomes excessive.
    (ii) When the filter element has physical damage or tears.
    (iii) According to manufacturer's recommendations or pesticide 
product labeling, whichever is more frequent.
    (iv) In the absence of any other instructions or indications of 
service life, at the end of each day's work period.
    (7) The handler employer shall assure that when gas- or vapor-
removing respirators are used, the gas- or vapor-removing canisters or 
cartridges shall be replaced:
    (i) At the first indication of odor, taste, or irritation.
    (ii) According to manufacturer's recommendations or pesticide 
product labeling, whichever is more frequent.
    (iii) In the absence of any other instructions or indications of 
service life, at the end of each day's work period.
    (8) The handler employer shall inform any person who cleans or 
launders personal protective equipment:
    (i) That such equipment may be contaminated with pesticides.

[[Page 230]]

    (ii) Of the potentially harmful effects of exposure to pesticides.
    (iii) Of the correct way(s) to clean personal protective equipment 
and to protect themselves when handling such equipment.
    (9) The handler employer shall assure that handlers have a clean 
place(s) away from pesticide storage and pesticide use areas where they 
may:
    (i) Store personal clothing not in use.
    (ii) Put on personal protective equipment at the start of any 
exposure period.
    (iii) Remove personal protective equipment at the end of any 
exposure period.
    (10) The handler employer shall not allow or direct any handler to 
wear home or to take home personal protective equipment contaminated 
with pesticides.
    (g) Heat-related illness. When the use of personal protective 
equipment is specified by the labeling of any pesticide for the handling 
activity, the handler employer shall assure that no handler is allowed 
or directed to perform the handling activity unless appropriate measures 
are taken, if necessary, to prevent heat-related illness.



Sec. 170.250  Decontamination.

    (a) Requirement. During any handling activity, the handler employer 
shall provide for handlers, in accordance with this section, 
decontamination supplies for washing off pesticides and pesticide 
residues.
    (b) General conditions. (1) The handler employer shall provide 
handlers with enough water for routine washing, for emergency 
eyeflushing, and for washing the entire body in case of an emergency. At 
all times when the water is available to handlers, the handler employer 
shall assure that it is of a quality and temperature that will not cause 
illness or injury when it contacts the skin or eyes or if it is 
swallowed.
    (2) When water stored in a tank is to be used for mixing pesticides, 
it shall not be used for decontamination or eye flushing, unless the 
tank is equipped with properly functioning valves or other mechanisms 
that prevent movement of pesticides into the tank.
    (3) The handler employer shall provide soap and single-use towels in 
quantities sufficient to meet handlers' needs.
    (4) The handler employer shall provide one clean change of clothing, 
such as coveralls, for use in an emergency.
    (c) Location. The decontamination supplies shall be located together 
and be reasonably accessible to and not more than \1/4\ mile from each 
handler during the handling activity.
    (1) Exception for mixing sites. For mixing activities, 
decontamination supplies shall be at the mixing site.
    (2) Exception for pilots. Decontamination supplies for a pilot who 
is applying pesticides aerially shall be in the airplaine or at the 
aircraft loading site.
    (3) Exception for handling pesticides in remote areas. When handling 
activities are performed more than 1/4 mile from the nearest place of 
vehicular access:
    (i) The soap, single-use towels, clean change of clothing, and water 
may be at the nearest place of vehicular access.
    (ii) The handler employer may permit handlers to use clean water 
from springs, streams, lakes, or other sources for decontamination at 
the remote work site, if such water is more accessible than the water 
located at the nearest place of vehicular access.
    (4) Decontamination supplies in treated areas. The decontamination 
supplies shall not be in an area being treated with pesticides or in an 
area under a restricted-entry interval, unless:
    (i) The decontamination supplies are in the area where the handler 
is performing handling activities;
    (ii) The soap, single-use towels, and clean change of clothing are 
in enclosed containers; and
    (iii) The water is running tap water or is enclosed in a container.
    (d) Emergency eyeflushing. To provide for emergency eyeflushing, the 
handler employer shall assure that at least 1 pint of water is 
immediately available to each handler who is performing tasks for which 
the pesticide labeling requires protective eyewear. The eyeflush water 
shall be carried by the handler, or shall be on the vehicle or aircraft 
the handler is using, or shall be otherwise immediately accessible.

[[Page 231]]

    (e) Decontamination after handling activities. At the end of any 
exposure period, the handler employer shall provide at the site where 
handlers remove personal protective equipment, soap, clean towels, and a 
sufficient amount of water so that the handlers may wash thoroughly.

[57 FR 38151, Aug. 21, 1992, as amended at 61 FR 33213, June 26, 1996]



Sec. 170.260  Emergency assistance.

    If there is reason to believe that a person who is or has been 
employed by an agricultural establishment or commercial pesticide 
handling establishment to perform pesticide handling tasks has been 
poisoned or injured by exposure to pesticides as a result of that 
employment, including, but not limited to, exposures from handling tasks 
or from application, splash, spill, drift, or pesticide residues, the 
handler employer shall:
    (a) Make available to that person prompt transportation from the 
place of employment or the handling site to an appropriate emergency 
medical facility.
    (b) Provide to that person or to treating medical personnel, 
promptly upon request, any obtainable information on:
    (1) Product name, EPA registration number, and active ingredients of 
any product to which that person might have been exposed.
    (2) Antidote, first aid, and other medical information from the 
product labeling.
    (3) The circumstances of handling of the pesticide.
    (4) The circumstances of exposure of that person to the pesticide.



PART 171--CERTIFICATION OF PESTICIDE APPLICATORS--Table of Contents




Sec.
171.1  General.
171.2  Definitions.
171.3  Categorization of commercial applicators of pesticides.
171.4  Standards for certification of commercial applicators.
171.5  Standards for certification of private applicators.
171.6  Standards for supervision of noncertified applicators by 
          certified private and commercial applicators.
171.7  Submission and approval of State plans for certification of 
          commercial and private applicators of restricted use 
          pesticides.
171.8  Maintenance of State plans.
171.9  Submission and approval of Government Agency Plan.
171.10  Certification of applicators on Indian Reservations.
171.11  Federal certification of pesticide applicators in States or on 
          Indian Reservations where there is no approved State or Tribal 
          certification plan in effect.

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

    Source: 39 FR 36449, Oct. 9, 1974, unless otherwise noted.



Sec. 171.1  General.

    This section deals with the certification of applicators of 
restricted use pesticides.



Sec. 171.2  Definitions.

    (a) General. Terms used in this subpart shall have the meanings set 
forth for such terms in the Act. In addition, the following definitions 
are applicable to all aspects of the certification of pesticide 
applicator program in this part:
    (1) The term accident means an unexpected, undesirable event, caused 
by the use or presence of a pesticide, that adversely affects man or the 
environment.
    (2) The term Act means the Federal Insecticide, Fungicide, and 
Rodenticide Act, as amended (86 Stat. 973), and other legislation 
supplementary thereto and amendatory thereof.
    (3) The term Administrator means the Administrator of the 
Environmental Protection Agency, or any office or employee of the Agency 
to whom authority has heretofore been delegated, or to whom authority 
may hereafter be delegated, to act in his stead.
    (4) The term Agency, unless otherwise specified, means the United 
States Environmental Protection Agency.
    (5) The term agricultural commodity means any plant, or part 
thereof, or animal, or animal product, produced by a person (including 
farmers, ranchers, vineyardists, plant propagators, Christmas tree 
growers, aquaculturists, floriculturists, orchardists, foresters, or 
other comparable persons) primarily for sale, consumption, propagation, 
or other use by man or animals.

[[Page 232]]

    (6) The term calibration of equipment means measurement of dispersal 
or output of application equipment and adjustment of such equipment to 
control the rate of dispersal, and droplet or particle size of a 
pesticide dispersed by the equipment.
    (7) The term certification means the recognition by a certifying 
agency that a person is competent and thus authorized to use or 
supervise the use of restricted use pesticides.
    (8) The term certified applicator means any individual who is 
certified to use or supervise the use of any restricted use pesticides 
covered by his certification.
    (9) The term commercial applicator means a certified applicator 
(whether or not he is a private applicator with respect to some uses) 
who uses or supervises the use of any pesticide which is classified for 
restricted use for any purpose or on any property other than as provided 
by the definition of ``private applicator.''
    (10) The term compatibility means that property of a pesticide which 
permits its use with other chemicals without undesirable results being 
caused by the combination.
    (11) The term competent means properly qualified to perform 
functions associated with pesticide application, the degree of 
capability required being directly related to the nature of the activity 
and the associated responsibility.
    (12) The term common exposure route means a likely way (oral, 
dermal, respiratory) by which a pesticide may reach and/or enter an 
organism.
    (13) The term environment means water, air, land, and all plants and 
man and other animals living therein, and the interrelationships which 
exist among them.
    (14) The term forest means a concentration of trees and related 
vegetation in non-urban areas sparsely inhabited by and infrequently 
used by humans; characterized by natural terrain and drainage patterns.
    (15) The term hazard means a probability that a given pesticide will 
have an adverse effect on man or the environment in a given situation, 
the relative likelihood of danger or ill effect being dependent on a 
number of interrelated factors present at any given time.
    (16) The term host means any plant or animal on or in which another 
lives for nourishment, development, or protection.
    (17) The term non-target organism means a plant or animal other than 
the one against which the pesticide is applied.
    (18) The term ornamental means trees, shrubs, and other plantings in 
and around habitations generally, but not necessarily located in urban 
and suburban areas, including residences, parks, streets, retail 
outlets, industrial and institutional buildings.
    (19) The term practical knowledge means the possession of pertinent 
facts and comprehension together with the ability to use them in dealing 
with specific problems and situations.
    (20) The term private applicator means a certified applicator who 
uses or supervises the use of any pesticide which is classified for 
restricted use for purposes of producing any agricultural commodity on 
property owned or rented by him or his employer or (if applied without 
compensation other than trading of personal services between producers 
of agricultural commodities) on the property of another person.
    (21) The term protective equipment means clothing or any other 
materials or devices that shield against unintended exposure to 
pesticides.
    (22) The term regulated pest means a specific organism considered by 
a State or Federal agency to be a pest requiring regulatory 
restrictions, regulations, or control procedures in order to protect the 
host, man and/or his environment.
    (23) The term restricted use pesticide means a pesticide that is 
classified for restricted use under the provisions of section 3(d)(1)(C) 
of the Act.
    (24) The term standard means the measure of knowledge and ability 
which must be demonstrated as a requirement for certification.
    (25) The term State means a State, the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Trust 
Territory of the Pacific Islands, and American Samoa.
    (26) The term susceptibility means the degree to which an organism 
is affected

[[Page 233]]

by a pesticide at a particular level of exposure.
    (27) The term toxicity means the property of a pesticide to cause 
any adverse physiological effects.
    (28) The term under the direct supervision of means the act or 
process whereby the application of a pesticide is made by a competent 
person acting under the instructions and control of a certified 
applicator who is responsible for the actions of that person and who is 
available if and when needed, even though such certified applicator is 
not physically present at the time and place the pesticide is applied.
    (b) Limited. The following definitions apply only to dealers, 
dealerships and transactions in States or on Indian Reservations where 
EPA conducts a Federal Pesticide Applicator Certification Program.
    (1) The term restricted use pesticide retail dealer means any person 
who makes available for use any restricted use pesticide, or who offers 
to make available for use any such pesticide.
    (2) The term make available for use means to distribute, sell, ship, 
deliver for shipment, or receive and (having so received) deliver, to 
any person. However, the term excludes transactions solely between 
persons who are pesticide producers, registrants, wholesalers, or retail 
sellers, acting only in those capacities.
    (3) The term dealership means any site owned or operated by a 
restricted use pesticide retail dealer where any restricted use 
pesticide is made available for use, or where the dealer offers to make 
available for use any such pesticide.
    (4) The term uncertified person means any person who is not holding 
a currently valid certification document indicating that he is certified 
under section 4 of FIFRA in the category of the restricted use pesticide 
made available for use.
    (5) The term principal place of business means the principal 
location, either residence or office, in the State in which an 
individual, partnership, or corporation applies pesticides.

[39 FR 36449, Oct. 9, 1974, as amended at 48 FR 53974, Nov. 1983]



Sec. 171.3  Categorization of commercial applicators of pesticides.

    (a) Procedure. Categories of applicators (other than private) using 
or supervising the use of restricted use pesticides are identified 
below. State systems of applicator identification shall adopt these 
categories as needed, along with such appropriate subcategories as are 
necessary to meet the particular requirements of the State.
    (b) Categories--(1) Agricultural pest control--(i) Plant. This 
category includes commercial applicators using or supervising the use of 
restricted use pesticides in production of agricultural crops, including 
without limiting the foregoing, tobacco, peanuts, cotton, feed grains, 
soybeans and forage; vegetables; small fruits; tree fruits and nuts; as 
well as on grasslands and non-crop agricultural lands.
    (ii) Animal. This category includes commercial applicators using or 
supervising the use of restricted use pesticides on animals, including 
without limiting the foregoing, beef cattle, dairy cattle, swine, sheep, 
horses, goats, poultry, and livestock, and to places on or in which 
animals are confined.

Doctors of Veterinary Medicine engaged in the business of applying 
pesticides for hire, publicly holding themselves out as pesticide 
applicators, or engaged in large-scale use of pesticides are included in 
this category.
    (2) Forest pest control. This category includes commercial 
applicators using or supervising the use of restricted use pesticides in 
forests, forest nurseries, and forest seed producing areas.
    (3) Ornamental and turf pest control. This category includes 
commercial applicators using or supervising the use of restricted use 
pesticides to control pests in the maintenance and production of 
ornamental trees, shrubs, flowers, and turf.
    (4) Seed treatment. This category includes commercial applicators 
using or supervising the use of restricted use pesticides on seeds.
    (5) Aquatic pest control. This category includes commercial 
applicators using or supervising the use of any restricted use pesticide 
purposefully applied to standing or running water, excluding applicators 
engaged in public health

[[Page 234]]

related activities included in category 8 below.
    (6) Right-of-way pest control. This category includes commercial 
applicators using or supervising the use of restricted use pesticides in 
the maintenance of public roads, electric powerlines, pipelines, railway 
rights-of-way or other similar areas.
    (7) Industrial, institutional, structural and health related pest 
control. This category includes commercial applicators using or 
supervising the use of restricted use pesticides in, on, or around food 
handling establishments, human dwellings, institutions, such as schools 
and hospitals, industrial establishments, including warehouses and grain 
elevators, and any other structures and adjacent areas, public or 
private; and for the protection of stored, processed, or manufactured 
products.
    (8) Public health pest control. This category includes State, 
Federal or other governmental employees using or supervising the use of 
restricted use pesticides in public health programs for the management 
and control of pests having medical and public health importance.
    (9) Regulatory pest control. This category includes State, Federal 
or other governmental employees who use or supervise the use of 
restricted use pesticides in the control of regulated pests.
    (10) Demonstration and research pest control. This category 
includes: (i) individuals who demonstrate to the public the proper use 
and techniques of application of restricted use pesticides or supervise 
such demonstration, and (ii) persons conducting field research with 
pesticides, and in doing so, use or supervise the use of restricted use 
pesticides. Included in the first group are such persons as extension 
specialists and county agents, commercial representatives demonstrating 
pesticide products, and those individuals demonstrating methods used in 
public programs. The second group includes: State, Federal, commercial 
and other persons conducting field research on or utilizing restricted 
use pesticides.
    (c) Other categories and subcategories. Any State submitting a plan 
pursuant to this section for the certification of applicators, as 
provided for below, may designate such subcategories within the above 10 
categories as it deems necessary. In addition, a State may delete a 
category not needed or may request the Administrator's approval of 
additional major categories.



Sec. 171.4  Standards for certification of commercial applicators.

    (a) Determination of competency. Competence in the use and handling 
of pesticides shall be determined on the basis of written examinations, 
and, as appropriate, performance testing, based upon standards set forth 
below and which are approved by the Administrator. Such examination and 
testing shall include the general standards applicable to all categories 
(Sec. 171.4(b)) and the additional standards specifically identified for 
each category or subcategory (if any) in which an applicator is to be 
classified (Sec. 171.4(c)). State standards must conform and be at least 
equal to those prescribed herein. In developing the details of standards 
at the State level and in structuring examinations, it is important to 
recognize and reflect the extent of competency appropriate and necessary 
to a particular category.
    (b) General standards for all categories of certified commercial 
applicators. (1) All commercial applicators shall demonstrate practical 
knowledge of the principles and practices of pest control and safe use 
of pesticides. Testing shall be based on examples of problems and 
situations appropriate to the particular category or subcategory of the 
applicator's certification and the following areas of competency:
    (i) Label & labeling comprehension. (a) The general format and 
terminology of pesticide labels and labeling;
    (b) The understanding of instructions, warnings, terms, symbols, and 
other information commonly appearing on pesticide labels;
    (c) Classification of the product, general or restricted; and
    (d) Necessity for use consistent with the label.
    (ii) Safety. Factors including:
    (a) Pesticide toxicity and hazard to man and common exposure routes;
    (b) Common types and causes of pesticide accidents;

[[Page 235]]

    (c) Precautions necessary to guard against injury to applicators and 
other individuals in or near treated areas;
    (d) Need for and use of protective clothing and equipment;
    (e) Symptoms of pesticide poisoning;
    (f) First aid and other procedures to be followed in case of a 
pesticide accident; and
    (g) Proper identification, storage, transport, handling, mixing 
procedures and disposal methods for pesticides and used pesticide 
containers, including precautions to be taken to prevent children from 
having access to pesticides and pesticide containers.
    (iii) Environment. The potential environmental consequences of the 
use and misuse of pesticides as may be influenced by such factors as:
    (a) Weather and other climatic conditions;
    (b) Types of terrain, soil or other substrate;
    (c) Presence of fish, wildlife and other non-target organisms; and
    (d) Drainage patterns.
    (iv) Pests. Factors such as: (a) Common features of pest organisms 
and characteristics of damage needed for pest recognition;
    (b) Recognition of relevant pests; and
    (c) Pest development and biology as it may be relevant to problem 
identification and control.
    (v) Pesticides. Factors such as:
    (a) Types of pesticides;
    (b) Types of formulations;
    (c) Compatibility, synergism, persistence and animal and plant 
toxicity of the formulations;
    (d) Hazards and residues associated with use;
    (e) Factors which influence effectiveness or lead to such problems 
as resistance to pesticides; and
    (f) Dilution procedures.
    (vi) Equipment. Factors including: (a) Types of equipment and 
advantages and limitations of each type; and
    (b) Uses, maintenance and calibration.
    (vii) Application techniques. Factors including:
    (a) Methods of procedure used to apply various formulations of 
pesticides, solutions, and gases, together with a knowledge of which 
technique of application to use in a given situation;
    (b) Relationship of discharge and placement of pesticides to proper 
use, unnecessary use, and misuse; and
    (c) Prevention of drift and pesticide loss into the environment.
    (viii) Laws and regulations. Applicable State and Federal laws and 
regulations.
    (c) Specific standards of competency for each category of commercial 
applicators. Some of the factors referenced in paragraph (b) of this 
section are of particular importance because of the different types of 
activities carried out by applicators in each category. Such factors 
must be especially stressed and specifically reflected in State 
certification standards, as appropriate. For example, practical 
knowledge of drift problems should be required of agricultural 
applicators but not of seed treatment applicators. The latter, however, 
should be particularly knowledgeable of the hazards of the misuse of 
treated seed and the necessary precautionary techniques. Many 
applicators in Sec. 171.3(b) (8), (9), and (10) will have had 
considerable formal education, training and experience in preparation 
for their positions. Their competency with respect to the use and 
handling of pesticides will have been determined by examining boards of 
their professional scientific societies utilizing standards which equal 
or exceed those prescribed herein. Such standards should be consulted by 
States in developing their State standards for certification of such 
applicators under these regulations. Commercial applicators in each 
category shall be particularly qualified with respect to the practical 
knowledge standards elaborated below:
    (1) Agricultural pest control--(i) Plant. Applicators must 
demonstrate practical knowledge of crops grown and the specific pests of 
those crops on which they may be using restricted use pesticides. The 
importance of such competency is amplified by the extensive areas 
involved, the quantities of pesticides needed, and the ultimate use of 
many commodities as food and feed. Practical knowledge is required 
concerning soil and water problems, pre-harvest intervals, re-entry 
intervals, phytotoxicity, and potential for environmental contamination, 
non-target

[[Page 236]]

injury and community problems resulting from the use of restricted use 
pesticides in agricultural areas.
    (ii) Animal. Applicators applying pesticides directly to animals 
must demonstrate practical knowledge of such animals and their 
associated pests. A practical knowledge is also required concerning 
specific pesticide toxicity and residue potential, since host animals 
will frequently be used for food. Further, the applicator must know the 
relative hazards associated with such factors as formulation, 
application techniques, age of animals, stress and extent of treatment.
    (2) Forest pest control. Applicators shall demonstrate practical 
knowledge of types of forests, forest nurseries, and seed production in 
their State and the pests involved. They should possess practical 
knowledge of the cyclic occurrence of certain pests and specific 
population dynamics as a basis for programming pesticide applications. A 
practical knowledge is required of the relative biotic agents and their 
vulnerability to the pesticides to be applied. Because forest stands may 
be large and frequently include natural aquatic habitats and harbor 
wildlife, the consequences of pesticide use may be difficult to assess. 
The applicator must therefore demonstrate practical knowledge of control 
methods which will minimize the possibility of secondary problems such 
is unintended effects on wildlife. Proper use of specialized equipment 
must be demonstrated, especially as it may relate to meteorological 
factors and adjacent land use.
    (3) Ornamental and turf pest control. Applicators shall demonstrate 
practical knowledge of pesticide problems associated with the production 
and maintenance of ornamental trees, shrubs, plantings, and turf, 
including cognizance of potential phytotoxicity due to a wide variety of 
plant material, drift, and persistence beyond the intended period of 
pest control. Because of the frequent proximity of human habitations to 
application activities, applicators in this category must demonstrate 
practical knowledge of application methods which will minimize or 
prevent hazards to humans, pets, and other domestic animals.
    (4) Seed-treatment. Applicators shall demonstrate practical 
knowledge of types of seeds that require chemical protection against 
pests and factors such as seed coloration, carriers, and surface active 
agents which influence pesticide binding and may affect germination. 
They must demonstrate practical knowledge of hazards associated with 
handling, sorting and mixing, and misuse of treated seed such as 
introduction of treated seed into food and feed channels, as well as 
proper disposal of unused treated seeds.
    (5) Aquatic pest control. Applicators shall demonstrate practical 
knowledge of the secondary effects which can be caused by improper 
application rates, incorrect formulations, and faulty application of 
restricted use pesticides used in this category. They shall demonstrate 
practical knowledge of various water use situations and the potential of 
downstream effects. Further, they must have practical knowledge 
concerning potential pesticide effects on plants, fish, birds, 
beneficial insects and other organisms which may be present in aquatic 
environments. These applicators shall demonstrate practical knowledge of 
the principles of limited area application.
    (6) Right-of-way pest control. Applicators shall demonstrate 
practical knowledge of a wide variety of environments, since rights-of-
way can traverse many different terrains, including waterways. They 
shall demonstrate practical knowledge of problems on runoff, drift, and 
excessive foliage destruction and ability to recognize target organisms. 
They shall also demonstrate practical knowledge of the nature of 
herbicides and the need for containment of these pesticides within the 
right-of-way area, and the impact of their application activities in the 
adjacent areas and communities.
    (7) Industrial, institutional, structural and health related pest 
control. Applicators must demonstrate a practical knowledge of a wide 
variety of pests, including their life cycles, types of formulations 
appropriate for their control, and methods of application that avoid 
contamination of food, damage and contamination of habitat, and exposure 
of people and pets. Since human exposure, including babies, children,

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pregnant women, and elderly people, is frequently a potential problem, 
applicators must demonstrate practical knowledge of the specific factors 
which may lead to a hazardous condition, including continuous exposure 
in the various situations encountered in this category. Because health 
related pest control may involve outdoor applications, applicators must 
also demonstrate practical knowledge of environmental conditions, 
particularly related to this activity.
    (8) Public health pest control. Applicators shall demonstrate 
practical knowledge of vector-disease transmission as it relates to and 
influences application programs. A wide variety of pests is involved, 
and it is essential that they be known and recognized, and appropriate 
life cycles and habitats be understood as a basis for control strategy. 
These applicators shall have practical knowledge of a great variety of 
environments ranging from streams to those conditions found in 
buildings. They should also have practical knowledge of the importance 
and employment of such non-chemical control methods as sanitation, waste 
disposal, and drainage.
    (9) Regulatory pest control. Applicators shall demonstrate practical 
knowledge of regulated pests, applicable laws relating to quarantine and 
other regulation of pests, and the potential impact on the environment 
of restricted use pesticides used in suppression and eradication 
programs. They shall demonstrate knowledge of factors influencing 
introduction, spread, and population dynamics of relevant pests. Their 
knowledge shall extend beyond that required by their immediate duties, 
since their services are frequently required in other areas of the 
country where emergency measures are invoked to control regulated pests 
and where individual judgments must be made in new situations.
    (10) Demonstration and research pest control. Persons demonstrating 
the safe and effective use of pesticides to other applicators and the 
public will be expected to meet comprehensive standards reflecting a 
broad spectrum of pesticide uses. Many different pest problems 
situations will be encountered in the course of activities associated 
with demonstration, and practical knowledge of problems, pests, and 
population levels occurring in each demonstration situation is required. 
Further, they should demonstrate an understanding of a pesticide-
organism interactions and the importance of integrating pesticide use 
with other control methods. In general, it would be expected that 
applicators doing demonstration pest control work possess a practical 
knowledge of all of the standards detailed in Sec. 171.4(b). In 
addition, they shall meet the specific standards required for paragraphs 
(c) (1) through (7) of this section as may be applicable to their 
particular activity.

Persons conducting field research or method improvement work with 
restricted use pesticides should be expected to know the general 
standards detailed in 171.4(b). In addition, they shall be expected to 
know the specific standards required for paragraphs (c) (1) through (9) 
of this section, applicable to their particular activity, or 
alternatively, to meet the more inclusive requirements listed under 
``Demonstration.''
    (d) Special standards. This space reserved for possible issuance of 
Special Standards.
    (e) The above standards do not apply to the following persons for 
purposes of these regulations. (1) Persons conducting laboratory type 
research involving restricted use pesticides; and
    (2) Doctors of Medicine and Doctors of Veterinary Medicine applying 
pesticides as drugs or medication during the course of their normal 
practice.



Sec. 171.5  Standards for certification of private applicators.

    (a) Competence in the use and handling of pesticides by a private 
applicator will be determined by procedures set forth below. State 
standards must conform and be at least equal to those prescribed herein. 
As a minimum requirement for certification, a private applicator must 
show that he possesses a practical knowledge of the pest problems and 
pest control practices associated with his agricultural operations; 
proper storage, use, handling and disposal of the pesticides and 
containers; and his related legal responsibility.

[[Page 238]]

This practical knowledge includes ability to:
    (1) Recognize common pests to be controlled and damage caused by 
them.
    (2) Read and understand the label and labeling information--
including the common name of pesticides he applied; pest(s) to be 
controlled, timing and methods of application; safety precautions; any 
pre-harvest or re-entry restrictions; and any specific disposal 
procedures.
    (3) Apply pesticides in accordance with label instructions and 
warnings, including the ability to prepare the proper concentration of 
pesticide to be used under particular circumstances taking into account 
such factors as area to be covered, speed at which application equipment 
will be driven, and the quantity dispersed in a given period of 
operation.
    (4) Recognize local environmental situations that must be considered 
during application to avoid contamination.
    (5) Recognize poisoning symptoms and procedures to follow in case of 
a pesticide accident.
    (b) Such competence of each private applicator shall be verified by 
the responsible State agency through the administration of a private 
applicator certification system which ensures that the private 
applicator is competent, based upon the standards set forth above, to 
use the restricted use pesticides under limitations of applicable State 
and Federal laws and regulations. A certification system shall employ a 
written or oral testing procedure, or such other equivalent system as 
may be approved as part of a State plan.
    (1) In any case where a person, at the time of testing for 
certification, is unable to read a label, the responsible State agency 
may employ a testing procedure, previously approved by the 
Administrator, which can adequately assess the competence of such person 
with regard to all of the above standards. Certification must be related 
and limited to the use and handling of each individual pesticide for 
which he desires certification at any time. Therefore, the applicator 
will be authorized to use only the pesticide(s) for which he has 
demonstrated competence. A specific procedure is required for 
Sec. 171.5(a)(2) relating to label comprehension, with testing designed 
to assure his knowledge of the following:
    (i) Understanding of the label and labeling information including 
those items indicated in that subsection.
    (ii) Sources of advice and guidance necessary for the safe and 
proper use of each pesticide related to his certification.
    (2) [Reserved]



Sec. 171.6  Standards for supervision of noncertified applicators by certified private and commercial applicators.

    (a) Certified applicators whose activities indicate a supervisory 
role must demonstrate a practical knowledge of Federal and State 
supervisory requirements, including labeling, regarding the application 
of restricted use pesticides by noncertified applicators.

The availability of the certified applicator must be directly related to 
the hazard of the situation. In many situations, where the certified 
applicator is not required to be physically present, ``direct 
supervision'' shall include verifiable instruction to the competent 
person, as follows: (1) Detailed guidance for applying the pesticide 
properly, and (2) provisions for contacting the certified applicator in 
the event he is needed. In other situations, and as required by the 
label, the actual physical presence of a certified applicator may be 
required when application is made by a noncertified applicator.
    (b) [Reserved]



Sec. 171.7  Submission and approval of State plans for certification of commercial and private applicators of restricted use pesticides.

    If any State, at any time, desires to certify applicators of 
restricted use pesticides, the Governor of that State shall submit a 
State plan for that purpose. The Administrator shall approve the plan 
submitted by any State, or any modification thereof, if the plan in his 
judgment--
    (a) Designates a State agency as the agency responsible for 
administering the plan throughout the State. Since several other 
agencies or organizations may also be involved in administering

[[Page 239]]

portions of the State plan, all of these shall be identified in the 
State plan, particularly any other agencies or organizations responsible 
for certifying applicators and suspending or revoking certification. In 
the extent that more than one governmental agency will be responsible 
for performing certain functions under the State plans, the plans shall 
identify which functions are to be performed by which agency and 
indicate how the program will be coordinated by the lead agency to 
ensure consistency of programs within the State. The lead agency will 
serve as the central contact point for the Environmental Protection 
Agency in carrying out the certification program. The numbers and job 
titles of the responsible officials of the lead agency and cooperating 
units shall be included.
    (b) Contains satisfactory assurances that such lead agency has or 
will have the legal authority and qualified personnel necessary to carry 
out the plan:
    (1) Satisfactory assurances that the lead agency or other 
cooperating agencies have the legal authority necessary to carry out the 
plans should be in the form of an opinion of the Attorney General or the 
legal counsel of the lead agency. In addition:
    (i) The lead agency should submit a copy of each appropriate State 
law and regulation.
    (ii) In those States where any requisite legal authorities are 
pending enactment and/or promulgation, the Governor (or Chief Executive) 
may request that a State plan be approved contingent upon the enactment 
and/or promulgation of such authorities. Plans approved on a contingency 
basis will be subject to such reasonable terms and conditions, 
concerning the duration of the contingency approval and other matters, 
as the Administrator may impose. During the period of the contingency 
approval, the State will have an approved certification program and may 
proceed to certify applicators, who will then be permitted to use or 
supervise the use of pesticides classified for restricted use under 
FIFRA, as amended.
    (iii) The State plan should indicate by citations to specific laws 
(whether enacted or pending enactment) and/or regulations (whether 
promulgated or pending promulgation) that the State has legal 
authorities as follows:
    (A) Provisions for and listing of the acts which constitute grounds 
for denying, suspending, and revoking certification of applicators, and 
for assessing criminal and/or civil penalties. Such grounds should 
include, at a minimum, misuse of a pesticide and falsification of any 
records required to be maintained by the certified applicator.
    (B) Provisions for reviewing an applicator's certification to 
determine whether suspension or revocation of the certification is 
appropriate in the event of criminal conviction under section 14(b) of 
the amended FIFRA, a final order imposing civil penalty under section 
14(a) of the amended FIFRA, or conclusion of a State enforcement action.
    (C) Provisions for right-of-entry by consent or warrant by 
appropriate State officials at reasonable times for sampling, 
inspection, and observation purposes.
    (D) Provisions making it unlawful for persons other than certified 
applicators or persons working under their direct supervision to use 
restricted use pesticides.
    (E) Provisions requiring certified commercial applicators to keep 
and maintain for the period of at least two years routine operational 
records containing information on kinds, amounts, uses, dates, and 
places of application of restricted use pesticides; and for ensuring 
that such records will be available to appropriate State officials.
    (2) Satisfactory assurances that the lead agency and any cooperating 
organizations have qualified personnel necessary to carry out the plan 
will be demonstrated by including the numbers, job titles and job 
functions of persons so employed.
    (c) Gives satisfactory assurances that the State will devote 
adequate funds to the administration of the plan.
    (d) Provides that the State agency will make reports to the 
Administrator in a manner and containing information that the 
Administrator may from time to time require, including:
    (1) An annual report to be submitted by the lead agency, at a time 
to be

[[Page 240]]

specified by the State, to include the following information:
    (i) Total number of applicators, private and commercial, by 
category, currently certified; and number of applicators, private and 
commercial, by category, certified during the last reporting period.
    (ii) Any changes in commercial applicator subcategories.
    (iii) A summary of enforcement activities related to use of 
restricted use pesticides during the last reporting period.
    (iv) Any significant proposed changes in required standards of 
competency.
    (v) Proposed changes in plans and procedures for enforcement 
activities related to use of restricted use pesticides for the next 
reporting period.
    (vi) Any other proposed changes from the State plan that would 
significantly affect the State certification program.
    (2) Other reports as may be required by the Administrator shall be 
submitted from time to time to meet specific needs.
    (e) Contains satisfactory assurances that the State standards for 
the certification of applicators of pesticides conform to those 
standards prescribed by the Administrator under Secs. 171.1 through 
171.6. Such assurances should consist of:
    (1) A detailed description of the State's plan for certifying 
applicators and a discussion of any special situations, problems, and 
needs together with an explanation of how the State intends to handle 
them. The State plan should include the following elements as a minimum:
    (i) For commercial applicators:
    (A) A list and description of categories and subcategories to be 
used in the State, such categories to be consistent with those defined 
in Sec. 171.3.
    (B) An estimate of the number of commercial applicators by category 
expected to be certified by the State.
    (C) The standards of competency elaborated by the State. These shall 
conform and be at least equal to those prescribed in Sec. 171.4 for the 
various categories of applicators utilized by the State. The standards 
shall also cover each of the points listed in the general standards in 
Sec. 171.4(b) and the points covered in the appropriate specific 
standards set forth in Sec. 171.4(c).
    (D) For each category and subcategory listed under 
Sec. 171.7(e)(1)(i)(A), either submission of examinations or a 
description of the types and contents of examinations (e.g., multiple 
choice, true-false) and submission of sample examination questions; and 
a description of any performance testing used to determine competency of 
applicators.
    (ii) For private applicators:
    (A) An estimate of the number of private applicators expected to be 
certified by the State.
    (B) The standards of competency elaborated by the State. These shall 
conform and be at least equal to those prescribed in Sec. 171.5(a), 
including the five requirements listed in Sec. 171.5(a) (1) through (5).
    (C) Types and contents of examinations and/or submission of detailed 
description of methods other than examination used to determine 
competency of private applicators.
    (D) A description of any special procedure of testing that a State 
develops to determine the competency of a private applicator who is 
unable to read the label as prescribed in Sec. 171.5(b)(1).
    (2) A provision for issuance by the State of appropriate credentials 
or documents verifying certification of applicators.
    (3) If appropriate, a description of any existing State licensing, 
certification or authorization programs for private applicators or for 
one or more categories of commercial applicators may be included. If 
these programs are determined by EPA to meet standards of competency 
prescribed by Secs. 171.1 through 171.6, States may certify applicators 
so licensed, certified or authorized without any additional 
demonstration of competency provided:
    (i) The commercial applicators who were licensed, certified, or 
authorized have demonstrated their competency based on written 
examinations and, as appropriate, performance testing, conforming to the 
standards set forth in Sec. 171.4, and
    (ii) The private applicators who were licensed, certified, or 
authorized have demonstrated their competency by written or oral testing 
procedures or other acceptable equivalent system,

[[Page 241]]

conforming to the standards set forth in Sec. 171.5.
    (4) A statement that the State accepts Federal employees qualified 
under the Government Agency Plan (GAP) as fully meeting the requirements 
for certification by that State; or a description of any additional 
requirements these employees must meet to apply restricted use 
pesticides in that State. Any such additional requirements shall be 
consistent with and shall not exceed standards established for other 
comparable applicators in that State.
    (i) Until such time as the GAP has been fully developed and approved 
by EPA, this statement (Sec. 171.7(e)(4)) is not required. However, 
within 60 days after final approval of the GAP, the State should forward 
such a statement for inclusion in its State plan.
    (5) A description of any cooperative agreements a State has made 
with any Indian Governing Body to certify or assist in the certification 
of applicators not subject to State jurisdiction. (Sec. 171.10).
    (6) A description of any arrangements that a State has made or plans 
to make relating to reciprocity with other States or jurisdictions for 
the acceptance of certified applicators from those States or 
jurisdictions. However, those arrangements should meet these conditions:
    (i) The State according reciprocity should provide for issuance of 
an appropriate document verifying certification based upon the 
certifying document issued by the other States or jurisdictions.
    (ii) The State according reciprocity should have enforcement 
procedures that cover out-of-State applicators determined to be 
competent and certified within the State or jurisdiction.
    (iii) The detailed State or jurisdiction standards of competency, 
for each category identified in