--------------------------------------------------------------------------------------------------------------------------------------------------------
 Mutagenicity...........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                                     Reverse mutation assay                    R             R          TGAI          TGAI               31, 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                                     In vitro mammalian gene                   R             R          TGAI          TGAI               31, 33
870.5375...................................   mutation
--------------------------------------------------------------------------------------------------------------------------------------------------------

870.5380                                     In vivo cytogenetics                      R             R          TGAI          TGAI               31, 34
870.5385...................................
870.5395...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Special Testing........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7485                                     Metabolism and                            R              CR PAI or PAIRA  PAI or PAIRA                  35
                                              pharmacokinetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                                     Companion animal safety                    CR            CR          NR              Choice             36
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7600                                     Dermal penetration                         CR            CR            Choice        Choice             37
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7800                                     Immunotoxicity                            R             R          TGAI          TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
    1. Not required if test material is a gas or highly volatile
liquid.
    2. For the six acute toxicity studies conducted with the end-use
product, the test must be conducted using the product as formulated
for sale and distribution. However, if the end-use product is
labeled that the product is to be diluted for use, the applicant may
also conduct certain studies using the highest diluted concentration
(i.e. the least diluted product) permitted by the labeling. The end-
use dilution testing is in addition to the as- formulated-for-sale
testing and used only for labeling purposes. Consultation with the
Agency is highly suggested to assure that the appropriate product
and any appropriate dilutions are tested.
    3. Not required if test material is corrosive to skin or has pH
less than 2 or greater than 11.5.
    4. Data are required when the product consists of, or under
conditions of use will result in, a respirable material (e.g., gas,
vapor, aerosol or particulates).
    5. Data are required if repeated dermal exposure is likely to
occur under conditions of use.
    6. For low exposure uses, data are required if the neurotoxicity
screen in the 90-day oral rodent study or other data indicate
neurotoxicity.
    7. The 90-day dermal toxicity study or 90-day inhalation
toxicity study may be substituted for the 90-day oral toxicity study
if the Agency determines that dermal or inhalation exposure is a
major route of exposure.
    8. All 90-day subchronic studies in the rodent can be designed
to simultaneously fulfill the requirements of the 90-day
neurotoxicity study by adding separate groups of animals for
testing.
    9. The 90-day study is required in the rodent for hazard
characterization (possibly endpoint selection) and dose-setting for
the chronic/carcinogenicity study. It is not required in the mouse,
but the Agency would encourage the applicant to conduct a 90-day
range finding study for the purposes of dose selection for the mouse
carcinogenicity study to achieve adequate dosing and an acceptable
study. The applicant is also encouraged to consult with the Agency
on the results of the 90-day mouse study prior to conducting the
carcinogenicity study.
    10. A 1-year non-rodent study (i.e., 1-year dog study) may be
required if the Agency finds that a pesticide chemical is highly
bioaccumulating and is eliminated slowly. Thus it does not achieve
steady state or sufficient tissue concentrations to elicit an effect
during a 90-day study. EPA may require the appropriate tier II
metabolism and pharmacokinetic studies to evaluate more precisely
bioavailability, half life, and steady state to determine if a
longer duration dog toxicity study is needed.
    11. For low human exposure uses, data are required if any of the
following criteria are met:
    i. The use of the pesticide is likely to result in repeated
human exposure over a limited portion of the human lifespan, as
determined by the Agency.
    ii. The use is an indirect food use (less than 200 ppb).
    12. Data are required if the intended use of the antimicrobial
pesticide product is expected to result in human exposure to the
product, and the three following conditions are met:
    i. Human exposure is via skin contact.
    ii. Expected human exposure is not purposeful, and is over a
limited portion of the human lifespan; however, as determined by
EPA, the exposure is significant in terms of the frequency of
exposure, magnitude of exposure, or the duration of exposure.
    iii. Data from a subchronic 90-day dermal toxicity study are not
available and the 90-day dermal toxicity study has not been
triggered.
    13. EP testing is required if the product or any component of
the product may increase dermal absorption of the active
ingredient(s) or increase toxic or pharmacologic effects, as
determined by testing the TGAI or based on available information
about the toxic effects of the product or its components.
    14. Data are required if the use pattern is such that the dermal
route would be the major route of exposure or if 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.
    15. A 90-day oral toxicity test is not required for heating,
ventilation, air conditioning, and refrigeration systems
(collectively referred to as HVAC), and two 90-day toxicity tests,
one by the dermal route and one by the inhalation route are
required.
    16. Data are required if there is the likelihood of significant
repeated inhalation exposure to the pesticide as a gas, vapor, or
aerosol.
    17. Based on estimates of the magnitude and duration of human
exposure, studies of shorter duration, e.g., 21- or 28-days, may be
sufficient to satisfy this requirement. Applicants for registration
may consult with the Agency to determine whether studies of shorter
duration would meet this requirement.
    18. Based on the positive results of the acute and/or 90-day
neurotoxicity studies, or on other data indicating neurotoxicity, a
chronic/neurotoxicity study (i.e. a chronic study with additional
neurotoxicity evaluations) may be required to provide information
about potential neurotoxic effects from long-term exposures.
    19. Studies which are designed to simultaneously fulfill the
requirements of both the chronic oral and carcinogenicity studies
(i.e., a combined study) may be conducted.
    20. For low exposure, data are required if either of the
following criteria are met:
    i. The use of the pesticide is likely to result in repeated
human exposure over a limited portion of the human lifespan, as
determined by the Agency, or
    ii. The use requires that a tolerance or a tolerance exemption
be established.

    21. For low exposure, data are required if any of the following
criteria, as determined by the Agency, are met:
    i. The use of the pesticide is likely to result in significant
human exposure over a considerable portion of the human life span
which is significant in terms of frequency time, duration, and/or
magnitude of exposure.
    ii. The use requires that a tolerance or a tolerance exemption
be established.
    iii. The active ingredient, metabolite, degradate, or impurity
    A. is structurally related to a recognized carcinogen,
    B. causes mutagenic effects as demonstrated by in vitro or in
vivo testing, or
    C. produces a morphologic effect in any organ (e.g.,
hyperplasia, metaplasia) in subchronic studies that may lead to a
neoplastic change.
    22. If the requirement for a carcinogenicity study in any
species is modified or waived for any reason, then a subchronic 90-
day oral study in the same species may be required.
    23. Testing in two species is required for all uses.
    24. The oral route, by oral intubation, is preferred, unless the
chemical or physical properties of the test substance, or the
pattern of exposure, suggest a more appropriate route of exposure.
    25. Additional testing by other routes of exposure may be
required if the pesticide is determined to be a prenatal
developmental toxicant after oral dosing.
    26. The developmental toxicity study in rodents may be combined
with the two-generation reproduction study in rodents by using a
second mating of the parental animals in either generation.
Protocols must be approved by the Agency prior to the initiation of
the study. Details for developing protocols are available from the
Agency.
    27. A two-generation reproduction study is required.
    28. An information-based approach to testing is preferred, which
utilizes the best available knowledge on the chemical (hazard,
pharmacokinetic, or mechanistic data) to determine whether a
standard guideline study, an enhanced guideline study, or an
alternative study should be conducted to assess potential hazard to
the developing animal, or in some cases to support a waiver for such
testing. Applicants must submit any alternative proposed testing
protocols and supporting scientific rationale to the Agency.
Protocols must be approved by the Agency prior to the initiation of
the study. Details for developing protocols are available from the
Agency.
    29. The use of a combined two-generation reproduction/
developmental neurotoxicity study that utilizes the two-generation
reproduction study in rodents as a basic protocol for the addition
of other endpoints or functional assessments in the immature animal
is encouraged.
    30. A DNT study is required using a weight-of-evidence approach
when:
    i. The pesticide causes treatment-related neurological effects
in adult animal studies (i.e, clinical signs of neurotoxicity,
neuropathology, functional or behavioral effects).
    ii. The pesticide causes treatment-related neurological effects
in developing animals, following pre- or post-natal exposure (i.e.,
nervous system malformations or neuropathy, brain weight changes in
offspring, functional or behavioral changes in the offspring).
    iii. The pesticide elicits a causative association between
exposures and adverse neurological effects in human epidemiological
studies.
    iv. The pesticide evokes a mechanism that is associated with
adverse effects on the development of the nervous system (i.e.,
structure-activity-relationship (SAR) to known neurotoxicants,
altered neuroreceptor or neurotransmitter responses).
    31. To enhance the weight-of-evidence determination for the
pesticide's mutagenicity, the Agency requires submission of other
mutagenicity test results, besides those specifically listed in this
table, that may have been performed for other endpoints that may be
predictive of mutagenicity. A reference list of all studies and
papers known to the applicant concerning the mutagenicity of the
test chemical must be submitted with the required studies.
    32. Testing in Salmonella and E. coli may be acceptable, if the
testing can be conducted at high enough levels, as determined by the
Agency. If the testing cannot be conducted at high enough levels,
then the applicant must consult with the Agency to determine other
needed mutagenicity testing.
    33. For the in vitro mammalian gene mutation study, there is a
choice of assays using either mouse lymphoma L5178Y cell thymidine
kinase (tk) gene locus, maximizing assay conditions for small colony
expression and detection; Chinese hamster ovary (CHO) or Chinese
hamster lung fibroblast (v79) cells, hypoxanthine-guanine
phosphoribosyl transferase (hgprt) gene locus, accompanied by an
appropriate in vitro test for clastogenicity; or CHO cells strains
AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
    34. There is a choice of assays, but initial consideration
should be given to the rodent bone marrow assay. The micronucleus
rodent bone marrow assay is preferred; the rodent bone marrow assays
using metaphase analysis (aberrations) are acceptable.
    35. For low exposure, these data are required when chronic or
carcinogenicity studies are also required. These data may be
required if significant adverse effects are seen in available
toxicology studies and these effects can be further elucidated by
metabolism studies.
    36. These data may be required if the product's use will result
in exposure to domestic animals through, but not limited to, direct
application.
    37. A risk assessment assuming that dermal absorption is equal
to oral absorption must be performed to determine if the dermal
penetration study is required, and to identify the doses and
duration of exposure for which dermal absorption is to be
quantified.

Sec.  158.2240  Nontarget organisms.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (e) of this section to determine the
terrestrial and aquatic nontarget organisms and nontarget plant
protection data requirements for a particular antimicrobial pesticide
product. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (f)
of this section.
    (1) Terrestrial and aquatic nontarget organism data are required to
support the registration of most end-use and manufacturing-use
antimicrobial products.
    (2) Data are generally not required to support end-use products of
a gas, highly volatile liquid, highly reactive solid, or a highly
corrosive material.
    (3) If the Agency determines that the transformation products of
the parentcompound are more toxic, persistent, bioaccumulative, or have
been shown to cause adverse effects in mammalian or aquatic
reproductive studies, then data on those transformation products are
required to support registration.
    (4) For wood preservatives, the Agency may require data on both the
parent compound, which is incorporated into wood, and on
transformation/degradation products which occur in wood post-treatment
or occur as dislodgeable residues (such as hand contact with treated
wood) or leachate residues (such as from soil or water contact with
treated wood).
    (b) Low environmental exposures. For the purpose of determining
data requirements, the low environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (9) Recirculating industrial processes and water systems in which
the treated water is re-used repeatedly within the system.
    (c) High environmental exposures. For the purposes of determining
data requirements, the high environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Once-through industrial processes and water systems in which
the water is not re-used, and is released after a single cycle through
the system.

    (2) Antifoulant paints and coatings.
    (3) Wood preservatives.
    (4) Aquatic areas.
    (d) Key. MP = Manufacturing use product; EP = End use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product; PAIRA = Pure active ingredient radiolabeled; a.i. = active
ingredient.
    (e) Table. The following table shows the data requirements for
nontarget organisms. The test notes appear in paragraph (f) of this
section.

                                                                   Table -- Antimicrobial Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Pattern                                   Test Substance to
                                                                                -------------------------------------------------------------------------         Support
                                                                                High Environmental Exposure               ------------------------
                                                                                ----------------------------------------------------------                           Test Note
               Guideline Number                          Data Requirement               Low          Industrial                                                                          No.
                                                                                Environmental   Processes and    Antifoulant       Wood        Aquatic       MP          EP
                                                                                Exposure     Water Systems   Coatings and  Preservatives     Areas
                                                                                (Once-Through)     Paints
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier One Testing................................................................................................................................................................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                                        Acute avian oral toxicity                    R                 R             R              R           R        TGAI        TGAI             1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                                        Acute freshwater invertebrates               R                 R             R              R           R        TGAI        TGAI             2
                                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                                        Acute freshwater fish toxicity               R                 R             R              R           R        TGAI        TGAI             3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Higher Tier Testing.............................................................................................................................................................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                                        Avian dietary toxicity                        CR                CR            CR             CR         R        TGAI        TGAI          4, 5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300                                        Avian reproduction                            CR                CR            CR             CR         R        TGAI        TGAI          1, 6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                                        Acute freshwater invertebrates                CR               R            NR             NR           R         ---         TEP          2, 7
                                                 toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                                        Acute freshwater fish toxicity                CR               R            NR             NR           R         ---         TEP             7
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1025                                        Acute estuarine and marine                    CR                CR           R               CR          CR      TGAI        TGAI          8, 9
850.1035......................................   organisms toxicity
850.1045......................................
850.1055......................................
850.1075......................................
                                               -------------------------------------------------------------------------------------------------------------------------------------------------
                                                Acute estuarine and marine                    CR                CR          NR             NR            CR       ---         TEP          7, 8
                                                 organisms toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1400                                        Fish early-life stage                         CR               R             R               CR         R        TGAI        TGAI            10
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                                        Aquatic invertebrate life- cycle              CR               R             R               CR         R        TGAI        TGAI            10
850.1350......................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1500                                        Fish life-cycle                               CR                CR            CR             CR          CR      TGAI        TGAI        11, 12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

850.1710                                        Aquatic organisms,                            CR                CR            CR             CR          CR TGAI.PAI,   TGAI.PAI,            13
850.1730......................................   bioavailability,                                                                                degradate   degradate
850.1850......................................   biomagnification, toxicity tests
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                                        Simulated or actual field testing             CR                CR            CR             CR          CR       TEP         TEP    14, 15, 16
                                                 for aquatic organisms
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1735                                        Whole sediment; acute freshwater              CR                CR           R               CR          CR      TGAI        TGAI        15, 17
                                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1740                                        Whole sediment; acute marine                  CR                CR           R               CR          CR      TGAI        TGAI    15, 17, 19
                                                 invertebrates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
None                                            Whole sediment; chronic                       CR                CR            CR             CR          CR      TGAI        TGAI    15, 18, 19
                                                 invertebrates fresh-water and
                                                 marine
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3020                                        Honeybee acute contact                        CR              NR            NR               CR        NR        TGAI        TGAI            20
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3030                                        Toxicity of residues to honeybees             CR              NR            NR               CR        NR        TGAI      TEP or            21
                                                                                treated
                                                                                wood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (f) Test notes. The following test notes apply to the data
requirements in the table to paragraph (e) of this section:
    1. For low environmental exposures, data are required for one
avian species. For industrial processes and water systems (once-
through), antifoulant paints and coatings, wood preservatives, and
aquatic areas, data are required for one waterfowl species and one
upland game bird species.
    2. Data are required on one freshwater aquatic invertebrate
species.
    3. For low environmental exposures, data are required on one
species of fish, either one cold water species or a warm water
species. Testing on a second species is required if the active
ingredient or principal transformation products are stable in the
environment and the LC50 in the first species is greater
than 1 ppm or 1mg/L. For all other use patterns, data are required
on two species of fish, one cold water species and one warm water
species.
    4. For low environmental exposures, industrial processes and
water systems (once-through), antifoulant paints and coatings, and
wood preservatives, data are required for one waterfowl species, if
the avian acute oral LD50 (TGAI testing) is less than or
equal to 100 mg a.i./kg and a.i. residues or its principal
transformation products are likely to occur in avian feed items.
Data on one upland game bird species are required if the avian
dietary LC50 in the first species tested is less than or
equal to 500 ppm a.i. in the diet.
    5. For aquatic areas, data are required on one waterfowl species
and one upland game bird species.
    6. For low environmental exposures, industrial processes and
water systems (once-through), antifoulant paints and coatings, and
wood preservatives, data are required if one or more of the
following criteria are met:
    i. Birds may be subjected to repeated or continued exposure to
the pesticide or any of its transformation 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 a
potentially toxic amount may persist in avian feed.
    iii. The pesticide or any of its major metabolites or
degradation products are stored or accumulated in plant or animal
tissues, as indicated by the octanol/water partition coefficient
(Kow is greater than or equal to 1,000), 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 indicate that reproduction in terrestrial
vertebrates may be adversely affected by the anticipated use of the
pesticide product.

    7. TEP testing is required for any product which meets one or
more of the following conditions:
    i. The estimated environmental concentration (EEC) in the
aquatic environment is equal to or greater than one-half the
LC50/EC50 of the TGAI when the end-use product
is used as directed.
    ii. An ingredient in the end-use product other than the active
ingredient is expected to enhance the toxicity of the active
ingredient or to cause toxicity to aquatic organisms.
    8. Data are required on one estuarine/marine mollusk, one
estuarine/marine invertebrate, and one estuarine/marine fish
species.
    9. For low environmental exposures, industrial processes and
water systems (once-through), wood preservatives, and aquatic areas,
data are required if the pesticide residues from the parent compound
and/or transformation products are likely to enter the estuarine/
marine environment.
    10. For low environmental exposures, data are required if
pesticide residues from the parent compound or transformation
products are likely to enter freshwater or estuarine/marine
environments, as determined by the Agency. For wood preservatives,
data are required if pesticide residues from the parent compound,
transformation products, and/or leachates from preservative-treated
wood are likely to enter freshwater or estuarine/marine
environments, as determined by the Agency. Testing should be
conducted with the most sensitive organism (either freshwater or
estuarine/marine vertebrates, or freshwater or estuarine/marine
invertebrates), as determined from the results of the acute toxicity
tests (acute EC50 freshwater invertebrates; acute
LC50/EC50 estuarine and marine organisms;
acute freshwater fish LC50.)
    11. Data are required on estuarine /marine species if the
product is intended for direct application to the estuarine or
marine environment, or the product is expected to enter this
environment in significant concentrations (as determined by the
Agency) because of its expected use or mobility patterns.
    12. Data are required on freshwater species if the end-use
product is intended to be applied directly to water, or is expected
to be transported to water from the intended use site, and when one
or more of the following conditions apply:
    i. If the Estimated Environmental Concentration (EEC) in water
is equal to or greater than 0.1 of the no-observed-effect
concentration or no-observed-effect level (NOEC/NOEL) in the fish
early-life stage or invertebrate life-cycle tests.
    ii. If studies of other organisms indicate that the reproductive
physiology of fish may be affected.
    13. Not required when:
    i. The octanol/water partition coefficients of the pesticide and
its major degradates are less than 1,000; or
    ii.There are no potential exposures to fish and other nontarget
aquatic organisms; or
    iii. The hydrolytic half-life is less than 5 days at pH 5, 7,
and 9.
    14. Environmental chemistry methods used to generate data
associated with this study must include results of a successful
confirmatory method trial by an independent laboratory. Test
standards and procedures for independent laboratory validation are
available as addenda to the guideline for this test requirement.
    15. Protocols must be approved by the Agency prior to the
initiation of the study. Details for developing protocols are
available from the Agency.
    16. Data are required if the intended use pattern, and the
physical/chemical properties and environmental fate characteristics
of the antimicrobial indicate significant potential exposure and
based on the results of the acute and chronic aquatic organism
testing significant impairment of nontarget aquatic organisms could
result.
    17. Data are required if the half-life of the pesticide in the
sediment is equal to or less than 10 days in either the aerobic soil
or aquatic metabolism studies, and if one or more of the following
conditions are met:
    i. The soil partition coefficient (Kd) is equal to or
greater than 50.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    18. Data are required if the EEC in sediment is > 0.1 of the
acute LC50/EC50 values and if one or more of
the following conditions are met:
    i. The soil partition coefficient (Kd) is equal to or
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    19. Sediment testing with estuarine/marine test species is
required if the product is intended for direct application to the
estuarine or marine environment or the product is expected to enter
this environment in significant concentrations (as determined by the
Agency) either by runoff or erosion, because of its expected use or
mobility pattern.
    20. Data are required only for beehive applications when the
beehive (empty or occupied) is treated.
    21. If beehives are constructed of treated wood a study similar
to ``Honey Bee Toxicity of Residues on Foliage'' is required using
treated wood instead of the foliage. Protocols must be approved by
the Agency prior to the initiation of the study. Details for
developing protocols are available from the Agency.

Sec.  158.2250  Nontarget plant protection.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (e) of this section to determine the
nontarget plant protection data requirements for a particular
antimicrobial pesticide product. Notes that apply to an individual test
including specific conditions, qualifications, or exceptions are listed
in paragraph (f) of this section.
    (b) Low environmental exposures. For the purpose of determining
data requirements, the low environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (9) Recirculating industrial processes and water systems in which
the treated water is re-used repeatedly within the system.
    (c) High environmental exposures. For the purposes of determining
data requirements, the high environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Once-through industrial processes and water systems in which
the water is not re-used, and is released after a single cycle through
the system.
    (2) Antifoulant paints and coatings.
    (3) Wood preservatives.
    (4) Aquatic areas.
    (d) Key. MP = Manufacturing use product; EP = End use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product.
    (e) Table. The following table shows the data requirements for
nontarget plant protection. The test notes appear in paragraph (f) of
this section.

                                                                      Table -- Nontarget Plant Protection Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Pattern                                Test Substance to Support
                                                                               ----------------------------------------------------------------------------------------------------
                                                                                High Environmental Exposure
                                                                                ----------------------------------------------------
                                                                                Industrial                                                                        Test Note
               Guideline Number                        Data Requirement          Low Environmental   Processes                                                                           No.
                                                                                Exposure        and Water  Antifoulant       Wood        Aquatic        MP            EP
                                                                                Systems     Coatings   Preservatives     Areas
                                                                                (Once-     and Paints
                                                                                Through)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                                       Seedling emergence, Tier II -                     CR         R            R             R            R           TEP           TEP          1, 2
                                                dose response
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4250                                       Vegetative vigor, Tier II -                       CR          CR         NR             R            R           TEP           TEP          1, 3
                                                dose response
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4400                                       Aquatic plant growth (aquatic                     CR         R            R             R            R     TGAI, TEP     TGAI, TEP          2, 4
                                                vascular plant) Tier II - dose
                                                response
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.5400                                       Aquatic plant growth (algal)                     R           R            R             R            R     TGAI, TEP     TGAI, TEP       4, 5, 6
                                                Tier II (dose response)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                                       Terrestrial field                                 CR          CR           CR            CR           CR         TEP           TEP       7, 8, 9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4450                                       Aquatic field                                     CR          CR           CR            CR           CR         TEP           TEP       7, 8, 9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (f) Test notes. The following test notes apply to the data
requirements in the table to paragraph (e) of this section:
    1. Data on only one plant species (rice, Oryza sativa) are
required.
    2. For low environmental exposures, data are required if the
aquatic (algal) plant growth Tier II study demonstrates detrimental
effects at less than 1.0 ppm or mg/L.
    3. For low environmental exposures, and industrial processes and
water systems (once-through), data are required if one or more of
the following criteria are met:
    i. The octanol/water partition coefficient (Kow) for
the active ingredient or principal transformation products >= 1,000
for the active ingredient or principal transformation products;
    ii. The hydrolysis half-life of the active ingredient or
principal transformation products in water is > 4 days.
    iii. The results of the ready biodegradability study [Sec.
158.2280] indicate that the active ingredient or principal
degradation products are not biodegradable in 28 days, i.e. the
biodegradation curve has not reached a plateau for at least three
determinations within the 28 days.
    4. For TEP testing, data are required for the applicant's end-
use product if an ingredient in the end-use product, other than the
active ingredient, is expected to enhance the toxicity of the active
ingredient.
    5. One Tier II (dose response) study, conducted with Selenastrum
capricornutum, is required for the low environmental exposure
category grouping. If the results of this study exhibits detrimental
effects (is less than 1.0 ppm or mg/L), then additional Tier II
(dose response) studies are required on three species (Anabaena
flos-aquae, Navicula pelliculosa, and Skeletonema costatum.
    6. For industrial processes and water systems (once-through),
antifoulant coatings and paints, wood preservatives, and aquatic
areas, Tier II (dose response) studies are required on four species
(Anabaena flos-aquae, Navicula pelliculosa, Skeletonema costatum,
and Selenastrum capricornutum.
    7. Environmental chemistry methods used to generate data must
include the results of a successful confirmatory method trial by an
independent laboratory.
    8. Tests are required on a case-by-case basis based on the
results of lower tier plant protection studies, adverse incident
reports, intended use pattern(s), and environmental fate
characteristics that indicate potential exposure.
    9. Protocols must be approved by the Agency prior to the
initiation of the study. Details for developing protocols are
available from the Agency.

Sec.  158.2260  Applicator exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (d) of this section to determine the
applicator exposure data requirements for antimicrobial pesticide
products. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (e)
of this section.
    (1) If EPA determines that industrial standards, such as the
workplace standards set by the Occupational Safety and Health
Administration, provide adequate protection for a particular pesticide
or a particular use pattern, applicator exposure data may not be
required for that pesticide or the use pattern. Applicants should
consult with the Agency on appropriate testing before the initiation of
studies.
    (2) The Agency may accept surrogate exposure data estimations from
other sources to satisfy applicator exposure data requirements if the
data meet the

basic quality assurance, quality control, good laboratory practice, and
other scientific requirements set by EPA. In order to be acceptable,
the Agency must find that the surrogate exposure data estimations have
adequate information to address applicator exposure data requirements
and contain enough adequate replicates of acceptable quality to reflect
the specific use prescribed on the label and the applicator activity of
concern, including formulation type, application methods and rates,
type of activity, and other pertinent information. The Agency will
consider using such surrogate data for evaluating human exposure on a
case-by-case basis.
    (3) Occupational uses include not only handlers, mixers, loaders,
and applicators, but also commercial applications to residential sites.
Residential uses are limited to non-occupational, i.e., non-
professional, antimicrobial applications. Both occupational and
residential applicator data may be required for the same product.
    (b) Criteria for testing. Applicator exposure data described in
paragraph (d) of this section are required based on toxicity and
exposure criteria. Data are required if a product meets, as determined
by the Agency, at least one of the toxicity criteria in paragraph
(b)(1) of this section, and at least one of the exposure criteria in
paragraph (b)(2) of this section.
    (1) Toxicity criteria. i. Evidence of potentially significant
adverse effects have been observed in any applicable toxicity studies.
    ii. Scientifically sound epidemiological or poisoning incident data
indicate that adverse health effects may have resulted from handling of
the pesticide.
    (2) Exposure criteria. i. Dermal exposure may occur during use.
    ii. Respiratory exposure may occur during use.
    (c) Key. R = Required; CR = Conditionally required; TEP = Typical
end-use product.
    (d) Table. The following table shows the data requirements for
applicator exposure. The test notes appear in paragraph (e) of this
section.

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

    (e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
    1. Protocols must be approved by the Agency prior to the
initiation of the study. Details for developing protocols are
available from the Agency.
    2. Biological monitoring data may be submitted in addition to,
or in lieu of, dermal and inhalation passive dosimetry exposure
data, provided the human pharmacokinetics of the pesticide or
metabolite/analog compounds (i.e., whichever method is selected as
an indicator of body burden or internal dose) allow for the back
calculation to the total internal dose.
    3. For products with both indoor and outdoor uses, and similar
conditions of use, data are generally required for the indoor
applications only. However, data for outdoor uses are required if
the Agency expects outdoor uses to result in greater exposure than
indoor uses (e.g., higher use rates and application frequency, or
longer exposure duration, or application methods/equipment create
potential for increased dermal or inhalation exposure in outdoor
versus indoor use sites). In certain cases, when a pesticide is used
both indoors and outdoors under dissimilar conditions of use, the
Agency may require submission of applicator exposure data for both
use patterns.
    4. For metal working fluids (MWFs), the Agency can provide
written guidance concerning exposure, toxicity, and other data
requirements for ``open'' and ``closed'' MWF systems.
    5. Data reporting and calculations are required when handler
exposure data are required.

Sec.  158.2270  Post-application exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (d) of this section to determine the
post-application exposure data requirements for antimicrobial pesticide
products. The data generated during these studies are used to determine
the quantity of pesticide to which people may be exposed after
application. Notes that apply to an individual test, including specific
conditions, qualifications, or exceptions to the designated test, are
listed in paragraph (e) of this section.
    (1) For all end-use products, post-application exposure data are
required when certain toxicity criteria are met and the human
activities associated with the pesticide's use pattern can lead to
potential adverse exposures.
    (2) If EPA determines that industrial standards, such as the
workplace standards set by the Occupational Safety and Health
Administration, provide adequate protection for a particular pesticide
or a particular use pattern, post-application exposure data may not be
required for that pesticide or the use pattern. Applicants should
consult with the Agency on appropriate testing before the initiation of
studies.
    (3) The Agency may accept surrogate exposure data estimations from
other sources to satisfy applicator exposure data requirements if the
data meet the basic quality assurance, quality control, good laboratory
practice, and other scientific requirements set by EPA. In order to be
acceptable, the Agency must find that the surrogate exposure data
estimations have adequate information to address applicator exposure
data requirements and contain enough adequate replicates of acceptable
quality to reflect the specific use prescribed on the label and the
applicator activity of concern, including formulation type, application
methods and rates, type of activity, and other pertinent information.
The Agency will consider using such surrogate data for evaluating human
exposure on a case-by-case basis.

    (b) Criteria for Testing. Post-application exposure data described
in paragraph (d) of this section are required based on toxicity and
exposure criteria. Data are required if a product meets, as determined
by the Agency, at least one of the toxicity criteria in paragraph
(b)(1) of this section, and at least one of the exposure criteria in
paragraph (b)(2) of this section.
    (1) Toxicity criteria. (i) Evidence of potentially significant
adverse effects have been observed in any applicable toxicity studies.
    (ii) Scientifically sound epidemiological or poisoning incident
data indicate that adverse health effects may have resulted from
handling of the pesticide.
    (2) Exposure criteria. (i) Outdoor uses. (A) Occupational human
post-application exposure to residues of antimicrobial pesticides could
occur as the result of, but is not limited to, worker re-entry into
treatment sites, clean-up and equipment maintenance tasks, handling
wood preservative-treated wood, or other work-related activity.
    (B) Residential human post-application exposure to residues of
antimicrobial pesticides could occur following the application of
antimicrobials pesticides to outdoor areas and spaces at residential
sites, such as, but not limited to homes, daycare centers, and other
public buildings.
    (ii) Indoor uses. (A) Occupational human post-application exposure
to pesticide residues could occur following the application of the
antimicrobial pesticide to indoor spaces or surfaces.
    (B) Residential human post-application exposure to pesticide
residues could occur following the application of the antimicrobial
pesticide to indoor spaces or surfaces at residential sites, such as,
but not limited to homes, daycare centers, hospitals, schools, and
other public buildings.
    (c) Key. R = Required; CR = Conditionally required; NR = Not
required; TEP = Typical end-use product.
    (d) Table. The following table shows the data requirements for
post-application exposure. The test notes appear in paragraph (e) of
this section.

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

    (e) Test notes. The following test notes apply to the data
requirements in the table to paragraph (d) of this section:
    1. Protocols must be approved by the Agency prior to the
initiation of the study. Details for developing protocols are
available from the Agency.
    2. For residential wood preservative uses, data are required if
there is likely to be soil in contact with or adjacent to treated
wood, including but not limited to decks, play sets, and gazebos.
    3. The applicant must submit residue dissipation data in
conjunction with dermal exposure data, to establish chemical
transfer coefficients used to estimate transfer of residues to human
skin.
    4. For wood preservatives, data are required for treated wood
surfaces where post-application contact with treated wood is
anticipated.
    5. For occupational uses, data are required if the pesticide is
applied to or around surfaces, and if the human activity data
indicate that workers are likely to have post-application dermal
contact with treated indoor surfaces while participating in typical
activities.
    6. Data are required for residential sites. This includes but is
not limited to the following use patterns: commercial,
institutional, and industrial premises and equipment (including
residential school and daycare institutions); residential and public
access premises; material preservatives (including those used in
residential products including but not limited to paints and plastic
toys) and wood preservatives (when contact with treated wood is
likely to occur).
    7. Data are required for occupational and residential use sites
if the human activity data indicate the potential for post-
application dermal exposures while participating in typical
activities.
    8. Biological monitoring data may be submitted in addition to,
or in lieu of, dermal and inhalation passive dosimetry exposure data
provided the human pharmacokinetics of the pesticide or metabolite/
analog compounds (i.e., whichever method is selected as an indicator
of body burden or internal dose) allow for a back-calculation to the
total internal dose.
    9. Data are required for occupational sites if the vapor
pressure is greater than 1E-3 mmHg at 25[deg] C and there is the
potential for bystander exposure. Data are also required if aerosols
are generated where bystanders may be exposed.
    10. Biological monitoring data are required when passive
dosimetry techniques are not applicable for a particular exposure
scenario (such as a swimmer/spa exposure) and exposure estimates
from modeling techniques used in conjunction with the toxicity data
indicate a risk of concern.
    11. Data reporting and calculations are required when any post-
application exposure monitoring data are required.
    12. Data are required for residential sites if post-application
exposures, particularly those of children, are likely. The selection
of a sampling method will depend on the non-dietary pathway(s) of
interest. Data must be generated to consider all potential pathways
of non-dietary ingestion exposure that are applicable (e.g., soil
ingestion, hand-to-mouth transfer, and object-to-mouth transfer of
surface residues).

Sec.  158.2280  Environmental fate.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (e) of this section to determine the
environmental fate data requirements for antimicrobial pesticide
products. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (f)
of this section.
    (1) Environmental fate data are required to support the
registrations of all end-use and manufacturing-use antimicrobial
products.
    (2) If the Agency believes that the transformation products of the
parent compound are more toxic, persistent, or bioaccumulative than the
parent compound, or have been shown to cause adverse effects in
mammalian or aquatic reproductive studies, then data on those
transformation products are also required to support registration.
    (3) For wood preservatives, the Agency may require data on both the
parent compound that is incorporated into the wood, and on
transformation/degradation products that occur in wood post-treatment
or occur as dislodgeable residues (such as hand contact with treated
wood) or leachate residues (such as from soil or water contact with
treated wood).
    (b) Low environmental exposures. For the purpose of determining
data requirements, the low environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (9) Recirculating industrial processes and water systems in which
the treated water is re-used repeatedly within the system.
    (c) High environmental exposures. For the purposes of determining
data requirements, the high environmental exposure grouping of use
patterns includes the following use patterns or partial use patterns:
    (1) Once-through industrial processes and water systems in which
the water is not re-used, and is released after a single cycle through
the system.
    (2) Antifoulant paints and coatings.
    (3) Wood preservatives.
    (4) Aquatic areas.
    (d) Key. MP = Manufacturing use product; EP = End use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product; PAIRA = Pure active ingredient radiolabeled.
    (e) Table. The following table shows the data requirements for
environmental fate. The test notes appear in paragraph (f) of this
section.

                                                Table--Antimicrobial Environmental Fate Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Use Pattern                              Test Substance to Support
                                              -----------------------------------------------------------------------------------------------
                                                                          High Environmental Exposure
                                                             ----------------------------------------------------
                                    Data                      Industrial                                                                       Test Note
      Guideline Number          Requirement         Low       Pro-cesses                                                                          No.
                                               Environmental   and Water  Antifoulant       Wood        Aquatic        MP            EP
                                                  Exposure      Systems     Coatings   Preservatives     Areas
                                                                (Once-     and Paints
                                                               Through)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation Studies - Laboratory........................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.2120                      Hydrolysis                 R            R            R             R            R       TGAI or       TGAI or           1
                                                                                PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.2240                      Photodegradatio            R            R            R             R            R       TGAI or       TGAI or           2
                               n in water                                                                               PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.2410                      Photodegradatio           NR           NR           NR             R           NR       TGAI or       TGAI or          --
                               n in soil                                                                                PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Biodegradation Studies - Laboratory....................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.1110                      Activated                  R            R           NR            NR           NR          TGAI          TGAI          --
                               Sludge
                               Sorption
                               Isotherm
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.3110                      Ready                      R            R           NR            NR           NR          TGAI          TGAI           3
                               Biodegradabili
                               ty
--------------------------------------------------------------------------------------------------------------------------------------------------------
850.6800                      Modified                   R            R           NR            NR           NR          TGAI          TGAI          --
                               Activated
                               Sludge,
                               Respiration
                               Inhibition
                               Test
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.3220                      Porous Pot                  CR           CR         NR            NR           NR          TGAI          TGAI           4
                               Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Mobility Studies........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.1230                      Leaching and                CR          R            R             R            R       TGAI or       TGAI or        5, 7
835.1240....................   adsorption/                                                                              PAIRA         PAIRA
                               desorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metabolism Studies - Laboratory.........................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

835.4100                      Aerobic soil                CR           CR         NR             R             CR     TGAI or       TGAI or   5, 6, 8, 9
                               metabolism                                                                               PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.4200                      Anaerobic soil              CR         NR           NR              CR         NR       TGAI or       TGAI or    5, 8, 10
                               metabolism                                                                               PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.4300                      Aerobic aquatic             CR          R            R              CR          R       TGAI or       TGAI or    5, 8, 10
                               metabolism                                                                               PAIRA         PAIRA
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.4400                      Anaerobic                   CR          R            R              CR          R       TGAI or       TGAI or    5, 8, 10
                               aquatic                                                                                PAIRA         PAIRA
                               metabolism
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dissipation Studies -- Field............................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
835.6200                      Aquatic                     CR           CR           CR            CR          R           TEP           TEP   5, 11, 12,
                               (sediment)                                                                                13
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ground and Surface Water Monitoring.....................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
None                          Monitoring of               CR           CR           CR            CR           CR  residue of    residue of   11, 12, 14
                               representative                                                                         concern       concern
                               U.S. waters
--------------------------------------------------------------------------------------------------------------------------------------------------------
Special Studies.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
None                          Special                   NR           NR            R             R           NR          TGAI           TEP      15, 16
                               leaching
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (f) Test notes. The following test notes apply to the data
requirements in the table in paragraph (e) of this section:
    1. For testing antifoulant paints and coatings, testing is to be
performed with both sterile buffered distilled water and sterile
synthetic seawater at pH 5, 7, and 9.
    2. Not required when the electronic absorption spectra, measured
at pHs 5, 7 and 9, of the chemical and its hydrolytic products, if
any, show no absorption or tailing between 290 and 800 nm.
    3. The selection of the particular biodegradation study depends
on the physical and chemical properties of the test substance, and
the results of the activated sludge sorption isotherm and the
modified activated sludge studies.
    4. Required if the pass criteria for the ready biodegradation
study are not met. This means 70% or greater removal of dissolved
organic carbon and 60% or greater of theoretical oxygen demand or
theoretical carbon dioxide. These pass values must be reached in a
10-day window within the 28-day period of the test.
    5. For low environmental exposure uses, data are required based
on a weight-of-evidence evaluation of the results of the hydrolysis,
photodegradation in water, activated sludge sorption isotherm, ready
biodegradability, and modified activated sludge, respiration
inhibition tests.
    6. For industrial processes and water systems (once-through),
data are required based on a weight-of-evidence evaluation of the
results of the hydrolysis, photodegradation in water, activated
sludge sorption isotherm, ready biodegradability, and modified
activated sludge, respiration inhibition tests.
    7. Adsorption and desorption using a batch equilibrium method is
preferred. In some cases, as when the antimicrobial pesticide
degrades rapidly, soil column leaching with unaged or aged columns
may be more appropriate to fully characterize the potential mobility
of the parent compound and major transformation products.
    8. The environmental media (soil, water, hydrosoil, and biota)
to be utilized in these studies must be collected from areas
representative of potential use sites.
    9. For industrial processes and water systems (once-through),
and aquatic areas, data are required for use sites that are
intermittently dry.
    10. For wood preservatives, data are required if treated wood is
used in aquatic environments or in soils which may become flooded or
waterlogged.
    11. Environmental chemistry methods used to generate data
associated with this study must include results of a successful
confirmatory method trial by an independent laboratory.
    12. Protocols must be approved by the Agency prior to the
initiation of the study. Details for developing protocols are
available from the Agency.
    13. For industrial processes and water systems (once-through),
antifoulant paints and coatings, and wood preservatives, data are
required based on the potential for aquatic exposure and if the
weight-of-evidence indicates that the active ingredient or principal
transformation products are likely to have the potential for
persistence, mobility, nontarget aquatic toxicity, or
bioaccumulation.
    14. Data are required if the weight-of-evidence indicates that
the active ingredient or principal transformation products are
likely to occur in nontarget freshwater, estuarine, or marine waters
such that human or environmental exposures are likely to occur. The
Agency takes into account other factors such as the toxicity of the
chemical(s), available monitoring data and the vulnerability of the
freshwater, estuarine, or marine water resources in the
antimicrobial use area.
    15. For wood preservatives, an aquatic leaching study is
required. A soil leaching study is required if human or
environmental exposures are likely to occur from leachates that
contain the active ingredient or principal transformation products
from wood treated with a preservative product. For these studies,
the Agency accepts the following methods or their equivalents:
American Wood Preservers' Association (AWPA) Method E11-97 (aquatic
leaching), and AWPA Method E20-04 (soil leaching). Prior approval of
studies conducted according to E11-97 is not required. All other
protocols

must be approved by the Agency prior to the initiation of the study.
Details for developing protocols are available from the Agency.
    16. For antifoulant paints and coatings, a leaching study is
required. The Agency accepts the following method or its equivalent:
American Society for Testing and Materials (ASTM) Method D5108-90.
Prior approval of studies conducted according to D5108-90 is not
required. All other protocols must be approved by the Agency prior
to the initiation of the study. Details for developing protocols are
available from the Agency.

Sec.  158.2290  Residue chemistry.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (f) of this section to determine the
residue chemistry data requirements for antimicrobial pesticide
products.
    (b) Residue chemistry data are required for products described in
this paragraph.
    (1) Each end-use product bearing label directions for food-uses
that require a tolerance or tolerance exemption, including, but not
limited to the following:
    (i) Direct food uses such as antimicrobial products used to treat
animal or poultry drinking water, for egg washing, or fruit and
vegetable rinses.
    (ii) Indirect food uses such as antimicrobial products applied to a
surface or incorporated into a material that may contact food or feed.
Residues may be expected to transfer to such food or feed. Data are
required regardless of whether the antimicrobial is applied or
impregnated for the purpose of imparting antimicrobial protection to
external surfaces of the substance or article, or for the purpose of
protecting the substance or article itself.
    (iii) Aquatic uses that have the potential to result in residues in
potable water, or in water used for livestock and poultry drinking
water, irrigation of crops, or water containing fish that may be used
for human food.
    (iv) Wood preservative or antifoulant products intended for
treating wood that may be used for food purposes (e.g., lobster pots,
fish cages, or fish farms).
    (2) Each manufacturing-use product bearing directions for
formulation into an end-use product bearing food-uses described in
paragraph (b)(1) of this section.
    (c) Except as described in paragraph (b) of this section, residue
chemistry data are not required to support a tolerance exemption if
dietary exposure estimates are not needed due to low toxicity of the
active ingredient or theoretical (modeled) estimates of exposure are
adequate to assess dietary risk.
    (d) Key. R = Required; CR = Conditionally required; NR = Not
required; TGAI = Technical grade of the active ingredient; TEP =
Typical end-use product; PAI = Pure active ingredient; PAIRA = Pure
active ingredient radiolabeled; the residue of concern is determined by
the Agency.
    (e) Table. The following table shows the data requirements for
residue chemistry. The test notes appear in paragraph (f) of this
section.

                                               Table -- Antimicrobial Residue Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Pattern
                                                                 --------------------------------------------------
                                                                                Direct                                           Test Note
           Guideline Number                 Data Requirement      Agricultural   Indirect      Food       Aquatic        Test substance           No.
                                                                    Premises     Food Uses    Contact      Uses
                                                                                Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information..................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1100                                Chemical identity                  R            R           R           R   TGAI                             --
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1200                                Directions for use                 R            R           R           R   --                               --
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1550                                Proposed tolerance                 R            R           R           R   --                                1
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1560                                Reasonable grounds in              R            R           R           R   --                                1
                                         support of petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1650                                Submittal of analytical            R            R           R           R   PAI and residue of                2
                                         reference standards                                                         concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of the residue...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300                                Nature of the residue in            CR         NR           R           R   PAIRA                       3, 4, 5
                                         plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1300                                Nature of the residue in           R           NR            CR          CR PAIRA or radiolabeled       6, 7, 8
                                         livestock                                                                   plant metabolite
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analytical methods......................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1340                                Residue analytical                  CR           CR         R            CR Residue of concern                9
                                         methods for enforcement
                                         of tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1340                                Residue analytical                  CR           CR         R            CR Residue of concern               10
                                         methods for data
                                         collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1360                                Multiresidue method                 CR           CR         R            CR Residue of concern               11
                                         testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the residue................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1380                                Storage stability                  R            R           R           R   TEP or residue of                12
                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------

860.1500                                Crop field trials                   CR           CR         R           R   TEP                          13, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1520                                Processed food or feed            NR             CR          CR          CR TEP                              15
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1480                                Meat/milk/poultry/eggs              CR           CR          CR          CR TGAI or plant metabolite     16, 17
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400                                Potable water                      R           NR          NR           R   TEP                              18
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400                                Fish                              NR           NR          NR           R   TEP                              19
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1400                                Irrigated crops                   NR           NR          NR            CR TEP                              20
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1460                                Food-handling                     NR             CR         R          NR   TEP                              21
--------------------------------------------------------------------------------------------------------------------------------------------------------
860.1540                                Anticipated residues                CR           CR          CR          CR Residue of concern               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
None                                    Migration studies                 NR             CR        NR          NR   TGAI                             23
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (f) Test notes. The following test notes apply to the data
requirements in the table to paragraph (e) of this section:
    1. A petition proposing a numerical tolerance or a tolerance
exemption is required for any food or feed use subject to section
408 of the FFDCA if the use is not covered by an existing tolerance
or tolerance exemption.
    2. An analytical reference standard is required for any food or
feed use requiring a tolerance. Material safety data sheets must
accompany analytical standards as specified by OSHA in 29 CFR
1910.1200.
    3. For agricultural premises, data are required for postharvest
storage of plant commodities.
    4. Data are required for direct food contact uses, excluding egg
washes, to determine the transformation products in representative
foods.
    5. Data are required to support applications to water if any
residues could occur in irrigated crops, or to crops treated
directly in the field.
    6. Data are required when an antimicrobial pesticide is applied
directly to livestock, to livestock premises, to livestock drinking
water, to livestock feed, or to crops used for livestock feed.
    7. Data are required for aquatic uses if there is the potential
that the treated water could be used eventually for drinking
purposes by livestock.
    8. If results from the plant metabolism study show differing
metabolites in plants from those found in animals, then additional
livestock metabolism study(ies) involving dosing with the plant
metabolite(s) may be required.
    9. A residue analytical method suitable for enforcement purposes
is required whenever a numeric tolerance is proposed. Enforcement
methods must be supported by results of an independent laboratory
validation.
    10. A residue analytical method suitable for collecting data to
establish tolerances must quantitate all residues of concern, as
determined by the Agency.
    11. Data are required to determine whether the FDA/USDA
multiresidue methodology would detect and identify the antimicrobial
active ingredient and its metabolites.
    12. Data are required for any food or feed use requiring
magnitude of the residue studies unless analytical samples are
stored frozen for 30 days or less, and the active ingredient is not
known to be volatile or labile.
    13. Residue data are required if antimicrobial chemicals are to
be applied to mushroom houses, empty or occupied beehives, wood used
to construct beehives, or any use which could result in residues in
food or feed.
    14. If the antimicrobial chemical is applied to growing crops in
the field, then the requirements of 40 CFR part 158, subpart O
(terrestrial food or feed use pattern) apply.
    15. Data on the nature and level of residues in processed food
or feed are required if residues could potentially concentrate on
processing, thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity.
    16. Data are required when the pesticide use is a direct
application to livestock.
    17. Data are required if livestock premises are treated or if
pesticide residues are present in or on livestock feed items or
intentionally added to drinking water. These studies, however, may
not be required in cases where the livestock metabolism studies
indicate negligible transfer of pesticide residues of concern to
tissues, milk, and eggs at the maximum expected exposure level for
the animals.
    18. Data are required for antimicrobial pesticides applied
directly to water, if there is the potential that the treated water
could be used for drinking purposes by man or animals.
    19. For aquatic uses, data for fish are required for
antimicrobial pesticides applied directly to water inhabited, or
which will be inhabited, by fish that may be caught or harvested for
human consumption.
    20. Data are required for antimicrobial pesticides applied
directly to water that could be used for irrigation or to irrigation
facilities such as ditches.
    21. Data are required whenever a pesticide is to be used in a
food-handling or feed handling establishment unless theoretical
calculations, radiolabeled laboratory data, the nature of the
residue study, or other data show that residues will not occur in
food or feed. Use in a food-handling establishment also includes
fresh fruits and vegetables that undergo a rinse with either a
sanitizing solution, or with a disinfectant followed by a potable
water rinse.
    22. Data are required when estimates of risk using residues at
the tolerance level may result in a risk of concern. These data may
include washing, cooking, processing or degradation studies as well
as market basket surveys for a more precise residue determination.

    23. Migration of residue data are required for antimicrobial
pesticides applied to hard food surfaces or incorporated into
substrates (wood, plastic, paper, cloth, rubber or similar products)
intended for contact with food or feed when theoretical (modeled)
estimates of the amount of antimicrobial residue transferred to the
food or feed may result in a risk of concern. Protocols must be
approved by the Agency prior to the initiation of the study. Details
for developing protocols are available from the Agency.

PART 161--[AMENDED]

    6. The authority citation for part 161 continues to read as
follows:

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

Part 161  [Removed]

    7. Part 161 is removed:
[FR Doc. E8-23127 Filed 10-7-08; 8:45 am]

BILLING CODE 6560-50-S