However, the Agency is updating the guideline numbers. As a result
guideline 850.2300 through 850.2500 apply to various terrestrial data
requirements (avian and mammal), guideline 850.1025 through 850.1500
for aquatic animal data requirements (freshwater and marine fish and
invertebrate species), and guideline 850.4225 through 850.4450 for
nontarget plant studies.
    The Agency currently conditionally (CR) requires Tier III nontarget
insect testing depending on the results of the lowered testing for
nontarget insects. The Agency proposes to conditionally require (CR)
field pollinator testing (to address risks to bees) data (guideline
850.3040) as Tier III, if the product is expected to be transported
during application to air, soil, or water, which is determined in the
Tier II environmental fate studies. Based on industry information, and
fate data indication potential for exposure, we

might then require some type of Tier III testing. This testing would
have to be preceded by consultation with OPP, because it would be
directed at the problem identified earlier. We would need to consider
the species at risk, route of exposure, etc. Additional insect species
may have to be tested if necessary to address issues raised by use
patterns and potential exposure of important insect species, e.g.,
beneficial insects, endangered species. The guideline number is
guideline 850.4030.
    m. Product performance. Currently the Agency relies on Sec.
158.640 for product performance data requirements for biochemicals and
microbial pesticides. The Agency is proposing to include product
performance in the regulatory text for both biochemicals and microbial
pesticides to improve transparency. Product performance verification
can be important, especially for public health pests, for some of the
biochemical and microbial pesticides since we have seen independent
reports that some do not work as well as the conventional pesticide
products.

VIII. Microbial Pesticides Data Requirements (Subpart M)

A. Definition of Microbial Pesticide

    Amendment to part 158. The Agency is proposing a revision in the
definition of a microbial pesticide. The current definition at Sec.
158.65 of microbial pesticides is:
    Biochemical and microbial pesticides are generally distinguished
from conventional pesticides by their unique modes of action, low use
volume, target species specificity or natural occurrence. In addition,
microbial pesticides are living entities capable of survival, growth
reproduction and infection. ... Microbial pesticides include microbial
entities such as bacteria, fungi, viruses, and protozoans. The data
requirements apply to all microbial pesticides, including those that
are naturally-occurring as well as those that are genetically modified.
Each ``new'' variety of subspecies, or strain of an already registered
microbial pest control agent must be evaluated, and may be subject to
additional data requirements.
    The definition of a microbial pesticide in the proposed rule is as
follows:
    Microbial pesticide means a microorganism intended for
preventing, destroying, repelling, or mitigating any pest, or
intended for use as a plant regulator, defoliant, or desiccant,
that: (1) Is a eucaryotic microorganism including, but not limited
to, protozoa, algae, and fungi; (2) Is a procaryotic microorganism,
including, but not limited to, bacteria; or (3) Is an autonomous
replicating microscopic element, including, but not limited to,
viruses.
    This proposed definition of microbial pesticide is based on the
language in the current definition of microbial pesticide at Sec.
158.65 and the class of nonexempt biological control agents in Sec.
152.20(a)(2), but uses a structure for defining microbial pesticide
similar to that at 40 CFR 172.43. Specifically, the proposed definition
replicates the structure used in Sec.  172.43 that identifies the
intent of the microbial pesticide, for example, as the prevention or
destruction of a pest. The proposed definition also combines the
structure and examples at Sec.  152.20 with the current regulatory
structure to clarify the intended scope of the current regulatory
definition and relationship to Sec.  152.20. For example, the proposed
definition includes references to eucaryotic and procaryotic
microorganisms, terms not found in the current definition at Sec.
158.65 but found in Sec.  152.20(a)(3). The proposed definition also
clarifies that microbial pesticides include viruses and other similar
infective elements, while the ''autonomous replicating`` language is
intended to exclude pesticide components of microscopic cells that are
not able to replicate as separate entities, such as genetic constructs
inserted intentionally into the cells. None of these proposed
amendments are intended to change the scope of the current regulatory
definitions of microbial pesticide at Sec.  158.65 or of the exemption
provision at Sec.  152.20(a)(3).
    EPA is also proposing not to include in the definition of microbial
pesticide the phrase from current Sec.  158.65 distinguishing microbial
pesticides from conventional pesticides because the original definition
was more of a description of those characteristics that might be shared
by both biochemical pesticides and microbial pesticides. In this rule,
we have described biochemical pesticides separately and we can now be
more specific in defining microbial pesticides.
    EPA notes that microorganisms are known to produce many pesticidal
substances. These pesticidal substances, when used independently of the
microorganism, are considered to be biochemical pesticides,
conventional chemical pesticides, or antimicrobial pesticides,
depending on the mode of action and the use. The microorganism would
then usually be considered part of the manufacturing process. For
example, streptomycin, an antibiotic produced by a bacterium,
Streptomyces griseus, is registered as a conventional chemical
fungicide.

B. Applicability of Microbial Pesticide Data Tables

    EPA is proposing to create a new applicability provision expressly
providing that the microbial pesticide data tables apply to microbial
pesticides, as described previously, and to add to that paragraph
specifics on the types of microbials subject to the subpart M data
requirements.
    First, the language in current Sec.  158.65 states that ``each new
variety of subspecies, or strain of an already registered microbial
pest control agent must be evaluated, and may be subject to additional
data requirements.'' The proposed refinement now reads ``each new
isolate of a microbial pesticide is treated as a new strain and must be
registered independently of any similar registered microbial pesticide
strain and supported by data required in this subpart.'' This
refinement is simply intended to clarify the intent of the current
regulatory language.
    The second sentence added to the applicability provision states
that genetically modified microbial pesticides may be subject to
additional data or information requirements on a case-by-case basis
depending on the particular microorganism and/or its parent
microorganism(s), the proposed pesticide use pattern, and the manner
and extent to which the organism has been genetically modified. That
language is moved from current Sec.  158.65.
    The final sentence reads ``pest control organisms such as insect
predators, nematodes, and macroscopic parasites are exempt from the
requirements of FIFRA as authorized by section 25 (b) of FIFRA and
specified in Sec.  152.20 (a) of this chapter.'' That sentence is moved
from current Sec.  158.65 as well.
    In addition, the current regulatory text at Sec.  158.65 specifies
that the microbial ``data requirements apply to all microbial
pesticides, including those that are naturally-occurring as well as
those that are genetically modified.'' This language is not needed in
the definition; the use of the data requirements for microbial
pesticides is fully described in the section immediately following the
definition.
    Other portions of the current text at Sec.  158.65 are proposed to
be moved to the applicability subsection of subpart M, Sec.  158.1000,
or the other provision that seems generic Sec.  158.1010 to avoid
confusion on the definition of microbial pesticide. Specifically, EPA
is proposing to move current Sec.  158.65(b)(2) to proposed Sec.
159.1010.
    EPA is also proposing to use table descriptors NR (not required), R

(required), and CR (conditionally required) to be used as markers along
a spectrum of the likelihood that a data requirement applies. In other
words, it should be assumed that a required (R) data requirement is
required typically all the time. There may be some narrow or rare
conditions identified in test notes when data are not required. For
example, acute injection toxicity (intraperitoneal or intravenous) not
required when the microbial pesticide is a virus. In contrast, a
conditionally required (CR) data requirement is less likely to be
triggered compared to a required (R) data requirement, but more likely
include test notes indicating conditions when data are typically
required. For example, the primary dermal irritation is currently
conditionally required (CR) for microbial pesticides. The test note
indicates it is required (R) when dermal irritation is reported from
the acute dermal toxicity study. Specific criteria are identified with
the test note.

C. Amendment of Part 172

    The Agency is also proposing to replace the definition for a
microbial pesticide at 40 CFR 172.43 with the definition proposed here.
The proposed definition is broader than the definition at Sec.  172.43
in that it uses the term ``includes'' rather than ``means'' and
identifies a category for autonomous replicating microscopic elements,
rather than just including viruses. EPA is proposing a broader
definition because it has been EPA's experience that there are
microorganisms other than viruses that could be used as a pesticide but
that would otherwise be excluded by the definition at Sec.  172.43.

D. Product Analysis Data Requirements

    1. General. The Agency uses product analysis information to
determine whether impurities of toxicological or environmental concern
are present in the pesticide and formulated products. Product analysis
data requirements include product identity and composition data,
physical and chemical characteristics of a pesticide, plus any
intentionally added ingredients and impurities in the final pesticide
product. Included in this category are the specific, detailed
requirements for product identity and chemical analysis. The title of
the data requirements, ``microbial pesticides product chemistry data
requirements,'' is proposed to be revised to ``microbial pesticides
product analysis data requirements'' to better reflect the extra
identification procedures necessary to analyze living organisms. The
following discussion addresses the proposed data requirements.
    2. Product analysis data requirements. Currently, the Agency groups
all the physical and chemical properties studies under one section. The
Agency proposes instead to list the individual studies that are
included in the category of data requirements to support registration
(guideline 830.6302 through 830.7300). The Agency currently requires
(R) all product chemistry data to support registration, except for
analysis of samples and submittal of samples, which is proposed to be
required under residue chemistry data requirements.
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. a. Product identity,
manufacturing process, and deposition of a sample in a nationally
recognized culture collection. Currently these data are required as
guideline numbers 151-20, 151-21, and 151-22. The Agency proposes that
these data requirements would remain the same as before. However, we
are proposing to list each as a separate study: product identity;
manufacturing process; and, discussion of formation of unintentional
ingredients. The Agency proposes to list them as follows: product
identity (guideline 885.1100), manufacturing process and deposition of
a sample in a nationally recognized culture collection (guideline
885.1200), and discussion of formation of unintentional ingredients
(guideline 885.1300).
    b. Physical and chemical characteristics. The Agency currently
requires (R) physical and chemical characteristics data. The Agency
proposes to require (R) that the same studies and same endpoints be
evaluated, however the Agency is trying to be more clear by identifying
the individual pieces of the data requirement and separately identify
each in the data table. Specifically the studies are identified as:
color, physical state, odor, stability, storage stability, miscibility,
corrosion characteristics, pH, viscosity, and density (guidelines
830.6302 through 870.7300).
    c. Analysis of samples. This study (guideline 885.1400) is
currently conditionally required (CR) for EUPs and registrations. The
Agency proposes to revise this data requirement to be required (R),
since it is critical to have an analysis of samples to understand the
composition of the microbial pesticide and the potential for
contamination with other microorganisms.
    d. Certification of limits. This study is currently required (R)
except for nonfood uses. The Agency is proposing to expand this data
requirement to be required (R) for all uses. These studies are needed
to confirm the claims made on the label and to validate the
confidential statement of formula.
    e. Analytical methods. The analytical methods would typically
assure that you could quantify the confidential statement of formula.
This study is currently required (R), and the Agency proposes to
continue to require (R) these data, but under product identity and
discussion of unintentional ingredients data requirements, which
provide these data.
    f. Submittal of samples. This provision is typically intended to
enable EPA to identify the active ingredient and provide standards to
governmental agencies needing to monitor chemical pesticide residues
and is conditionally required (CR). The Agency proposes to require (R)
these data as a product analysis requirement to be deposited in a
nationally recognized culture collection to allow EPA to validate
strain identity if issues arise (guideline 885.1200).
    Since the Agency does not have capacity to store the variety of
microbial pesticides that may be submitted, EPA did not set up a
nationally recognized culture collection. There are several nationally
recognized culture collections in this country (and abroad) such as the
American Type Culture Collection and a microbial collection maintained
in Peoria, Ill., by the USDA. These facilities have a vast number of
microbial and cell cultures that are dedicated to transferring,
maintaining and identifying. Rather than duplicate this effort, EPA
chose to refer microbial pesticide producers to these facilities who
have the routine expertise to keep and distribute (or protect)
microbial cultures. There is a certain element of required expertise
but really the cost and small number of our microbial pesticides would
make it prohibitively expensive for the Agency to do this collection
rather than direct the companies to these specialized facilities.

E. Residue Chemistry Data Requirements

    1. General. The Agency uses residue chemistry information to
determine the potential bioavailability of pesticide residues on food.
Included in this subpart are the detailed requirements for chemical
identity, analytical methods for plants and animals, nature of residue,
stability, and magnitude of residue.
    2. Residue chemistry data requirements. The residue chemistry

data table currently requires residue data under one data requirement.
The Agency is proposing to delineate the residue data to clearly
identify the endpoints being measured. In other words, there is only
one data requirement, and in the proposed rule there are several data
requirements listed (guideline 885.2000 through 885.2350), but no more
additional data are actually required. In addition, the current test
note in part 158 delays the residue study requirement until Toxicology
Tier II and Tier III data are required (R). The Agency is proposing the
data requirement not be dependent on the Tier Data in II and III, but
to conditionally require (CR) these data when the results of testing
(indicated in test note).
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. Part 158 currently
requires residue data (153-4) for microbial pesticides, but does not
lay out clearly the various underlying studies for fulfilling the
actual requirement. EPA proposes the following be listed to provide
greater clarity and transparency of the data that are actually required
(R) to support registration: Background for residue analysis of
microbial pest control agents (guideline 885.2000), chemical identity
(guideline 885.2100), nature of residue (guideline 885.2200, 885.2250),
analytical methods (guideline 885.2300,885.2350), storage stability,
magnitude of residue (guideline 885.2500, 885.2550, 885.2600). These
data are currently required (R), therefore there is no revision in the
proposed rule.

F. Toxicology Data Requirements

    1. General. Toxicology data requirements encompass studies expected
to improve the Agency's understanding of the potential pesticide hazard
to humans, including subpopulations such as infants and children, and
domestic animals, for all microbial pesticides. These data requirements
include acute toxicity/infectivity studies (oral, dermal, inhalation,
pulmonary injection), a cell culture study, and hypersensitivity
incidents (guideline 885.3050 through 885.3500) to be submitted. In
addition, acute toxicity studies (oral, dermal, and inhalation) and the
primary eye and dermal irritation studies (guidelines 870.1100 through
870.2500) are also required. The Agency wants to specially note that we
are inviting public comment as to whether or not hypersensitivity
incidents (guideline 885.4300) is addressed adequately via the Sec.
152.125, FIFRA section 6 (a)(2) data requirement, also discussed in the
preamble for biochemical pesticides.
    The following identifies the revisions to the current Sec.  158.740
for microbial toxicology data requirements. Revisions include name
changes, test note clarifications, revisions under which use pattern
data are triggered (e.g., food use versus non-food use), and
clarification of other circumstances under which data are required.
    2. Toxicology data requirements. The Agency generally discourages a
registrant from pursuing registration of a microbial pesticide that is
a known human pathogen, even one reported to be an opportunistic human
pathogen, because it would be difficult to support a risk assessment
that would show no unreasonable risk to humans. However, in some cases,
a candidate microbial pesticide may:
    (a) Be very closely related to a human pathogen but lack the toxins
or invasive factors responsible for that disease;
    (b) Be taxonomically distinct from known human pathogens, but may
have picked up a toxin or other factor that could cause mammalian
disease as detected by Tier I and II studies; or,
    (c) Provide significant benefits that would offset some risk that
might additionally be mitigated by certain use/exposure considerations.
    The Agency has encountered several cases where microbial pesticides
are a member of a taxonomic group containing mammalian toxins. In these
instances, data gathering beyond the codified data requirements may be
required to account for potential human health risks. For most
applications, this kind of testing is not needed.
    Generally, toxicology data from Tier I is sufficient to address the
hazards related to the human health risk assessment for pathogenicity
and infectivity of microbial pesticides. The most common reason for
needing Tier II or higher tests is the appearance of unexplained
toxicity, unusual persistence, lethality, or adverse effects related to
treatment with the microbial pesticide in the Tier I studies.
    Some microbial products may be lethal to rodents at the Tier I and/
or Tier II levels, where the mode of action may not be sufficiently
clear to allow for specific toxin or other infectivity factors to be
analyzed. Furthermore, due to the nature of some microorganisms, the
possibility exists that rodents may not be a truly representative test
animal for determining effects on humans of a microbial pesticide.
    The Agency proposes to conditionally require (CR) Infectivity/
pathogenicity as a Tier III data requirement. This requirement allows
for the possible use of alternative test species, including primates as
described in the testing guidelines.
    In addition, there are ten revisions, primarily name changes to the
data requirements.
    i. New requirements--Infectivity/pathogenicity. Currently this
study is not required. The Agency is proposing to conditionally require
(CR) a Tier III infectivity/pathogenicity analysis (guideline 885.3000)
when the microbial pesticide appears to be a mammalian pathogen that
might sufficiently affect humans or nontarget mammals. While it is
possible that the registrant would not want to pursue a microbial
registration if such testing were triggered, the Agency believe it is
appropriate to establish a Tier III toxicity study requirement to
evaluate the microbial pesticides potential effects in higher animals.
The Agency believes this type of data would rarely be required.
However, if all criteria established in the revised test notes has been
exceeded, it is appropriate to require the data.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements-- a. Acute oral toxicity/
pathogenicity. Currently this study is required (R) with no test notes.
For clarity, the Agency is proposing a name change to the more
descriptive one used in the updated guidelines (guideline 885.3050).
EPA also proposes a reduction in the number of test substances required
to be tested. Currently, part 158 requires both MP or EP and TGAI. The
proposed rule would only require (R) the TGAI to be tested. TGAI is
only required for the acute oral toxicity/pathogenicity and can be done
with MP or EP to avoid the ``normal'' acute oral toxicity for the EP if
all endpoints and dosing are confirmed. The endpoint examined in the
toxicity/pathogenicity include clearance and immune functioning of the
test rodent. These endpoints, once determined, are not necessary for
more than the TGAI. The MP and the EP are not expected to dramatically
alter the pathogenicity character of the microbe so the extra testing
does not add to the safety assessment. The Agency is also proposing to
add a test note, indicating the acute oral study toxicity/pathogenicity
can be combined with the unit dose portion of acute oral toxicity study
(guideline 870.1100) if the new protocol is designed to address the
endpoints of concern.
    b. Acute pulmonary toxicity/pathogenicity. The Agency currently
requires (R) the acute inhalation study

(152-31) under Tier I. The Agency is proposing acute pulmonary
toxicity/pathogenicity (guideline 885.3150) to be required in lieu of
the acute inhalation study. EPA also proposes a reduction in number of
test substances required to be tested, currently both MP or EP and TGAI
are required. The proposed rule would only require (R) the TGAI to be
tested. These endpoints, once determined, are not needed for more than
the TGAI. As discussed previously, the MP and the EP are not expected
to dramatically alter the pathogenicity character of the microbe so the
extra testing does not add to the safety assessment.
    c. Acute injection toxicity/pathogenicity (Intravenous or
Intraperitoneal). The Agency currently requires (R) I.V., I.C., I.P.
injection study. The Agency is proposing acute injection toxicity/
pathogenicity (either intraperitoneal or intravenous) to also be
required (R), with the test note indicating the pathway under what
conditions the intravenous or intraperitoneal would be required.
Intracerebral is no longer required since it has been determined that
exposure would most likely result in intravenous or intraperitoneal
exposure. Under this revised data requirement, the data would not be
required if the active ingredient of the pesticide product is a virus.
    d. Primary dermal irritation. The Agency currently requires (R)
this data under Tier I. The Agency is proposing to conditionally
require (CR) these data as Tier I, with proposed test notes better
defining the conditions when the data requirement would apply. This
study would be conditionally required (CR) only if dermal irritation
was indicated in the acute dermal toxicity study, since it would be
evident in the results of the acute dermal toxicity study if primary
dermal toxicity effects could occur.
    e. Acute inhalation toxicity. Currently the Agency conditionally
requires (CR) an acute inhalation study (151-41) in Tier II on MP or EP
product when data in a Tier I acute inhalation study indicate potential
adverse effects (e.g., survival, replication, infectivity, toxicity).
The Agency is proposing to require (R) the acute inhalation toxicity
study (guideline 870.1300) as a Tier I, limiting it to testing MP or
EP, no longer requiring TGAI testing, but with a test note indicating
data are required only if the product can be inhaled.
    f. Hypersensitivity study and hypersensitivity incidents. Currently
the Agency requires (R) the hypersensitivity study and conditionally
requires (CR) hypersensitivity incidents. The Agency is proposing to
not require (NR) the hypersensitivity study and to require (R)
hypersensitivity incident reporting data. The hypersensitivity study
are currently submitted as part of product characterization on known
microbial hazards such as toxins and allergens.
    As indicated, the Agency proposes to revise hypersensitivity
incidents from the current conditionally required (CR) to proposed
required (R), even under conditions of EUP's. While these types of data
are already required under Sec.  152.125, FIFRA 6(a)(2), the status of
hypersensitivity incidents reporting is unclear for microbial products
that have not been registered or are under an EUP. Therefore, the
Agency included a requirement for hypersensitivity incident reporting
for EUP's in lieu of the hypersensitivity study. As previously
indicated, EPA is inviting comment as to whether or not this study is
needed, since the data must already be submitted to the Agency as
6(a)(2) data.
    g. Cell culture. The Agency proposes to rename the currently
required (R) tissue culture study for all viruses to the cell culture
data requirement (guideline 885.3500), since this study is a more
appropriate name for the tissue culture study and would only be
required when the product's active ingredient is a virus.
    h. Reproductive fertility effects. The Agency currently
conditionally requires (CR) teratogenicity data. The Agency is
proposing to conditionally require (CR) reproductive and fertility
effects data (guideline 885.3650). This study replaces both guidelines
152-47 and 152-53. This is actually a replacement, since the data are
basically assessing the same endpoints. The Agency is also proposing to
not require these data as Tier II, but as Tier III since the triggers
for this study rely on toxicity endpoints which are collected in Tier
II studies, i.e., guideline 885.3600.

G. Nontarget Organisms and Environmental Fate Data Requirements

    1. General. The Agency uses a tiered system of ecological effects
testing to assess the potential risks of pesticides to nontarget
aquatic and terrestrial vertebrates, invertebrates, and plants. These
tests include studies arranged in a hierarchy from basic laboratory
tests to applied field tests. The results of each tier are evaluated to
determine the potential impacts on fish, wildlife, and other nontarget
organisms, and to indicate whether further laboratory and/or field
studies are needed. These data requirements provide the Agency with
ecological effects information, which, in turn, allows the Agency to
determine if precautionary statements concerning toxicity or potential
adverse effects to nontarget organisms are necessary, or whether the
pesticide should be registered for certain use patterns at all.
    Higher tiered nontarget organisms and environmental fate studies
may be required when basic human health assessment data and predicted
exposure levels or environmental conditions suggest the potential for
adverse effects. Field data are used to examine acute and chronic
adverse effects on captive or monitored populations under natural or
near-natural environments. Such studies would be required only when the
potential for adverse effects is indicated by the results of lower tier
studies, or to confirm the need for mitigation measures. In some cases,
the results of field studies may also give rise to the need for further
testing.
    2. Nontarget organisms and environmental fate data requirements.
The proposed nontarget organisms and environmental fate data table
reflects the data that are currently required to support registration
of new microbials. Conditions under which data may be required are
stipulated in the test notes. In addition, there are a few studies that
would be replaced by more appropriate studies to measure the endpoint
of concern, and other studies would be deleted. These data revisions
are not be expected to substantively increase the nature or burden of
the existing data requirements.
    i. New requirements. None.
    ii. Newly codified requirements. None.
    iii. Revisions to existing requirements. a. Avian Inhalation
Toxicity/Pathogenicity. The Agency currently requires (R) an avian
injection test. The Agency proposes to replace the avian injection test
(154-17) with the avian inhalation test (guideline 885.4100) to provide
a more appropriate endpoint to assess risks to avian species. The
Agency is also proposing to conditionally require (CR) this data only
when the microbial pesticide appears to have toxins that indicate
potential pathogenicity. The inhalation study models a more realistic
route of exposure in the wild than intraperitoneal injection.
    b.  Fish life-cycle study and aquatic invertebrate range testing.
The Agency proposes to replace conditionally required (CR) aquatic
embryo larvae and life cycle studies (154-28) with conditionally
required (CR) fish life-cycle studies (guideline 885.4700) and
definitive aquatic animal tests (154-27) with aquatic invertebrate
range testing (guideline 885.4650) to provide more appropriate
endpoints for assessing risks to aquatic species (fish and

invertebrates). The ``fish'' life cycle study is more appropriate
because it identifies a particular taxonomic class to be tested as
opposed to ``aquatic embryo and life cycle studies'' which do not
identify the taxonomic class or species to be tested. ``Definitive
aquatic animal tests'' does not say what animal group (species) is to
be tested and does not say what test is to be done (``definitive'' is
not a test name), whereas ``aquatic invertebrate range testing'' is
more appropriate because it specifically instructs the registrant to
determine which aquatic invertebrate species are susceptible to the
pesticide and which are not susceptible. In summary, the Agency is
proposing to revise the titles of the data requirements in order to
account for species and life cycles being tested.
    c. Simulated or actual field testing for plants (guideline
850.2500). The Agency currently conditionally requires (CR) nontarget
plant studies (154-31) as Tier III when data in Tier II indicate there
is a concern. The Agency proposes to rename the data requirement to
simulated or actual field testing for plants (guideline 850.2500),
which is currently conditionally required (CR) on a case-by-case basis.
The test notes associated with the proposed requirement are more
explicit as to when the conditions would be met. In addition, these
data are proposed to be conditionally required (CR) as Tier IV.
    d. Product performance. Currently the Agency relies on Sec.
158.640 for product performance data requirements for biochemicals and
microbial pesticides. The Agency is proposing to include product
performance in the regulatory text for both biochemicals and microbial
pesticides to improve transparency. Product performance verification
can be important for some of the biochemical and microbial pesticides
since we have seen independent reports that some do not work as well as
the conventional pesticide products. It is particularly useful to have
product performance data for those products that want to be considered
as presenting less risk than a conventional pesticide product.
    e. Subchronic toxicity/pathogenicity. The Agency proposes to change
the name of the subchronic oral toxicity study (152-42) to correspond
with the current name of the test guideline.
    f. Carcinogenicity. The Agency proposes to change the name of the
oncogenicity study to carcinogenicity study (guideline 870.4200) to
correspond with the current name of the test guideline.

IX. Peer Review

A. National Research Council Recommendations

    As discussed in Unit V.A.3, the National Academy of Sciences issued
a report in 1993 entitled, ``Pesticides in the Diets of Infants and
Children.'' The study, conducted by the National Research Council, was
initiated to address the question of whether the current regulatory
system adequately protected infants and children from pesticide
residues in food. The Council reviewed current EPA practices and data
requirements related to dietary risk assessment as well as testing
modifications planned by the Agency. The panel of experts concluded
that, at that time, EPA approaches to data requirements and risk
assessments emphasized the evaluation of the effects of pesticides in
mature animals and, in general, there was a lack of data on pesticide
toxicity in developing organisms. The Council also expressed the need
to investigate the effects of pesticide exposure on immunotoxic
responses in infants and children (Ref. 3).

B. FIFRA Scientific Advisory Panel

    1. 1994 SAP Review. In 1994, EPA held a two day meeting of the SAP
to review the Agency's proposed amendments to the data requirements for
pesticide registrations contained in 40 CFR part 158. The SAP was asked
to comment on each data requirement and identify, in their opinion,
which ones were necessary to fully and thoroughly evaluate the
potential hazard of a chemical compound and which ones were not
intrinsically useful in providing practical scientific information.
While these data requirements were presented to SAP to support
conventional pesticides, the majority of changes to the data
requirements presented in this notice were submitted for review as
subpart M: Microbial and Biochemical Pesticides Data Requirements.
These revisions were generally endorsed by the SAP (Ref. 4). A copy of
the 1994 SAP final report can be found in the docket for this
rulemaking (docket ID number EPA-HQ-OPP-2004-0415).
    The limited issues that were addressed in1994 Panel's specific
comments are as follows:
     Intraperitoneal study. The issue revolved around whether
an intraperitoneal study is appropriate to use when microbial size or
physical properties preclude the use of intravenous study. At that
time, SAP believed the intraperitoneal study was appropriate to use
when microbial size or physical properties preclude the use of
intravenous study. This option is included in the proposed rule.
     Bird species. The issue revolved around whether the second
bird study gives significant additional information for microbial
effects, i.e., are the two birds species likely to respond differently
to typical biocontrol microbials. At the time, SAP suggested that it
was appropriate to use only the more sensitive bird species (the quail)
for data requirements. This recommendation has been included in the
test note.
     Fish species. The issue revolved around whether the second
fish study was likely to provide significant information for
microbials. At the time, SAP suggested that it was appropriate to use
the more sensitive fish species (trout) for data requirements. The SAP
recommendation was incorporated into the test note.
    Additionally, SAP encouraged the Agency to carefully evaluate the
data requirements for genetically engineered microbials. The SAP
believed this emerging technology was still, in many respects, an
unknown entity. In the future, EPA will develop data requirements for
plant-incorporated protectants.
    2. 1987 SAP Review--Immunotoxicity testing of biochemical pest
control agents (BPCAs) (Ref. 7). Proposed Guidelines for Immunotoxicity
Testing of Biochemical Pest Control Agents were presented to the SAP.
In particular the issues revolved around the use of a single sex of
test animal in the lower tiered studies. At that time, the 1987 SAP
decided that there was no scientific rationale for examining both male
and female animals, though this may not apply to compounds that
demonstrate estrogenic activity. In this case females may be the sex of
choice since they would be more sensitive to immunotoxic effects than
males by this class of compounds. A second issue raised at this meeting
was the inclusion of a limit test in Tier I, in which no adverse
immunological effects are observed at a single high dose, then no
further testing is required. The Agency was seeking advice on the
scientific criteria that would support the inclusion or exclusion of a
limit test in Tier I studies. At that time, the SAP deemed it
appropriate for all assays in Tier I to be included since no single
test can fully evaluate all cellular or functional components of the
immune system. A dose that produces a large amount of general toxicity
would be of concern since the general toxicity might indirectly
contribute to the immunotoxicity. Immunotoxicity data

should be cautiously evaluated in this context.
    3. 1986 SAP Review--Applicator/user exposure monitoring guidelines.
The Series 875, Group A, Applicator/User Exposure Monitoring Guidelines
were presented to SAP in January 1986. After EPA addressed SAP
comments, the guidelines were finalized. The guidelines were published
by the National Technical Information Service (NTIS) in 1987 (Ref. 10).
    A comprehensive listing of data requirements and the year that each
specific data requirement was reviewed by SAP is available in the
docket for this proposed rule (Ref. 11). Additionally, copies of
documents reviewed by SAP and the final reports can be found on EPA's
website at http:// www.epa.gov/scipoly/sap.

X. Animal Welfare Concerns

    The Agency is committed to the development and use of alternative
approaches to animal testing. The Agency understands many people's
concern about the use of animals for research and data development
purposes. EPA has received comments concerning the use of new and
revised test methods which would reduce the number of test animals in
studies, or refine procedures to make them less stressful to animals.
The Agency believes it has taken steps, based on current scientific
knowledge and experience, to minimize testing on biochemical and
microbial pesticides. With respect to these types of pesticides, the
Agency has implemented a tiered testing approach, thereby potentially
reducing the number of studies required for registration. Where testing
is needed to develop scientifically adequate data, the Agency is
committed to reducing or replacing, wherever possible, the number of
animals used for testing by incorporating in vitro (non-animal) test
methods or other alternative approaches that have been scientifically
validated and have received regulatory acceptance. EPA considers these
goals and commitments to be important considerations in developing
health effects data, consistent with the essential need to conduct
scientifically sound pesticide hazard/risk assessments in support of
the Agency's mission.
    Taking into consideration principles of sound science and the
requirements of FIFRA to protect humans (including sensitive
subpopulations) and the environment from unreasonable uncertainty of no
harm from pesticide exposure, the Agency is committed to avoiding
unnecessary or duplicative animal testing. For example, currently EPA
accepts data on the pH of a pesticide as a screen to judge whether the
pesticide may be corrosive to the eye or skin. Making this
determination avoids actual testing on animals. Many long-term studies
can be combined so that several toxicological end-points can be
discerned from fewer studies. The Agency already has bridging and
batching policies in place to allow the use of acute toxicity,
sensitization, or irritation test data on products to be used to
support other products.
    The Agency plays an important role in the Federal Interagency
Coordinating Committee on the Validation of Alternative Methods
(ICCVAM) (http://iccvam.niehs.nih.gov/home.htm). ICCVAM, a standing

committee made up of 15 Federal agencies and established through the
National Institute of Environmental Health Sciences, which works to (1)
encourage the reduction of the number of animals used in testing; (2)
seek opportunities to replace test methods requiring animals with
alternative test methods when acceptable alternative methods are
available; and (3) refine existing test methods to optimize animal use
when there is no substitute for animal testing. ICCVAM convenes
independent peer review panels to evaluate specific proposed test
methods and has developed consensus criteria for judging the validation
status of test methods.
    Guideline 870.1100 references the use of appropriate alternative
test protocols as a means of reducing the number of animals used to
evaluate acute effects of pesticide exposure. Yet the Agency and the
scientific community also recognize that test guidelines are designed
to be updated and supplemented frequently. As new tests and test
batteries are validated, the Agency presents them to the SAP. The
Agency considers the SAP's determination of the reliability of the test
guidelines and their applicability to meeting its regulatory needs
under FIFRA. After SAP review, the Agency is planning to incorporate
validated in vitro screening data for skin corrosion to its test
guidelines. As other appropriate alternative or in vitro methods become
available, they would continue to be added to the test guidelines.

XI. Data Requirements Specific to Endangered Species Assessments and
Determinations

    Over the last several years, the Agency has been requiring, on a
case-by-case basis for certain pesticides (mostly conventional chemical
pesticides), data demonstrating specific geographic location(s) of
threatened and endangered species (listed species), which can then be
compared with areas of potential pesticide use. These data have been
required when EPA determined that the estimated environmental
concentration of the pesticide when applied according to the labeling
appears to exceed the Agency's numeric concern levels for listed
species. The specific species for which location information was
needed, has been determined on a case-by-case basis based upon the use
pattern of the pesticide and the site on which it was authorized to be
used.
    In general, a biochemical pesticide is not expected to pose
endangered species concerns because it is a naturally-occurring
chemical or a synthetically-derived equivalent; has a history of
exposure to humans and the environment demonstrating minimal toxicity;
and has a non-toxic mode of action to the target pest(s). However, the
Agency has occasionally required such data for microbial pesticides
(e.g., Metarhizium anisopliae). The microbial pesticides typically have
a limited host range and affect only certain species limiting the
potential of such pesticides to pose endangered species concerns. The
Agency anticipates that these data could be requested in the future in
connection with other registration and reregistration actions for both
biochemical and microbial pesticides if lower tier studies show
potential adverse effects to nontarget organisms.
    In response to a Data Call-In notice on certain conventional
pesticides for data on the location of all listed species, an industry
taskforce is working to develop a database that may partly fulfill
Agency needs, i.e., geographic locations where potentially affected
species are thought to occur. Access to the task force data by other
registrants who may be required to provide such data in the future
would be made available through appropriate data sharing mechanisms.
Although the anticipated expanded burden on registrants is not large
since it does not entail experimental or laboratory procedures, it is
nevertheless not likely to be inconsequential. Thus, the Agency is
requesting comment on its utility and appropriateness.
    While EPA is using the best available scientific and commercial
information to assess risks to listed species, uncertainties still
exist. Further research and investigation might help to develop
improved risk assessment approaches. The Agency recognizes that such
research also could lead, in the long run, to additional data
requirements for registration. Accordingly, the Agency seeks input on
research areas that may be necessary to effectively characterize
potential risks to listed endangered

species from pesticide use. These include research to address the
following types of uncertainties:
     Product use information by geographic location below the
state and county levels.
     Toxicity data and environmental fate measurements/exposure
model predictions with end use products.
     Toxicity data from surrogate species that quantify dose-
response relationships for effects relevant to critical life stages of
endangered species.
     Measured or estimated values of physiological,
biochemical, and morphological characteristics of endangered species
and surrogate species to refine chemical-specific interspecies toxicity
extrapolations.
     Toxicity, exposure, uptake, and elimination data to better
determine any differences in interspecies sensitivity of nontarget and
endangered plant species exposed to herbicides.
     Toxicity data to characterize potential effects to aquatic
invertebrates (i.e., freshwater mussels).
     Toxicity data to characterize potential effects to
reptiles and amphibians.
    The Agency seeks comment on:
    1. The relative value of each of these research areas in better
refining assessments of potential risks to listed species.
    2. Input on specific research directions in these areas, including
methodologies, protocols etc., that would be appropriate and useful in
assessing the potential risks to listed species.
    3. Other types of research that would be of value in refining
potential risks of a pesticide to a listed species.
    4. The extent to which potential research areas reflect
uncertainties that apply to pesticides generically; to chemical
stressors generically, or to types of pesticides or chemicals
stressors.

XII. Research Involving Human Subjects

    This proposed rule (see proposed Sec.  158.950) would establish
data requirements for applicator/user exposure studies for biochemical
pesticides proposed as insect repellents. This data requirement is
consistent with Sec.  158.500 of the proposed rule for conventional
pesticides (70 FR 12275, March 11, 2005).
    On January 26, 2006, the EPA Administrator signed a final rule
entitled Protections for Humans Subjects in Research (71 FR 6138,
February 6, 2006), (Ref. 23) that significantly strengthens and expands
the protections for subjects of ``third-party'' human research (i.e.,
research that is not conducted or supported by EPA) by (1) prohibiting
new research involving intentional exposure of pregnant women or
children that is intended for submission to EPA under the pesticide
laws; (2) extending the provisions of the Federal Policy for the
Protection of Human Subjects of Research (the ``Common Rule'') to other
human research involving intentional exposure of non-pregnant adults
that is intended for submission to EPA under the pesticide laws; (3)
requiring submission to EPA of protocols and related information about
covered human research before it is initiated; and (4) establishing an
independent Human Studies Review Board to review both proposals for new
research and reports of covered human research on which EPA proposes to
rely under the pesticide laws.
    This rule forbids EPA to rely, in its actions under the pesticide
laws, on intentional-exposure human research that either involves
pregnant women or children as subjects or is otherwise considered
unethical, except in narrowly defined circumstances. Some studies
required under this part will also be subject to subparts K, L, and M
of 40 CFR part 26--the newly promulgated final rule for the protection
of human subjects of research. Subpart K extends the substantive
provisions of the ``Common Rule''--the ethical standard that governs
research with human subjects conducted or supported by EPA and other
Federal departments and agencies to third-party research that involves
intentional exposure of non-pregnant adults as subjects, and that is
intended for submission to EPA under the pesticide laws. Subpart K also
requires submission to EPA of proposals for any covered research, at
least 90 days before it is initiated, for review by EPA staff and the
Human Studies Review Board. Subpart L categorically prohibits any
third-party research that involves intentional exposure of pregnant
women, fetuses, or children as subjects, and that is intended for
submission to EPA. Subpart M specifies the range of information
required to be submitted along with reports of completed research with
human subjects to document the ethical conduct of the research.

XIII. Summary of Proposed Changes

    The Agency has prepared a document, entitled Summary of the
Proposed Changes (Ref. 1), to compare the current data requirements to
support the registration of biochemicals and microbials, respectively,
with the revised data requirements presented in this proposed rule. The
changes include: revision in test notes, revision in guideline names,
revisions in tiering the various data requirements, etc. Along with the
proposed changes to the data required, the Agency also proposes to
revise the definitions of biochemical pesticides and microbial
pesticides and to add definitions of pheromones, arthropod pheromones,
and straight chain lepidopteran pheromones.

XIV. Summary of Options

    What Options did the Agency Evaluate?
    The Agency evaluated three regulatory options to revising the
existing data requirements. The three options are generally
characterized by estimated annual cost or regulatory burden reduction
and frequency of requiring data. The options as presented are intended
to reflect broad conceptual approaches, and within each broad option
there are other options for requiring or reducing data requirements. In
addition, whether considered broadly or more narrowly, EPA's approach
is based on the primary need for sufficient information to make the
FIFRA/FFDCA findings while at the same time being mindful of
opportunities to reduce burden and testing where data is not value
added. Again, as noted previously, the point is to emphasize first the
need to meet statutory mandates.
    This section will briefly cover these three options. The specific
cost differences between these three regulatory options are discussed
in the executive summary of the Economic Analysis for this rulemaking
(Ref. 6). Overviews of estimated annual cost or regulatory burden
reduction for the proposed rulemaking as a whole may be found in Unit
XVI., Regulatory Assessment.
    1. Option 1 (reduced regulatory burden, potential risk). This low-
cost approach was designed to maximize burden reduction based upon the
specific nature of biochemical and microbial pesticides. Based on the
non-toxic mode of action and naturally-occurring characteristics of
many of these compounds, the Agency could perform a complete risk
assessment based on a minimal amount of nontarget organisms and
environmental fate data. For biochemical pesticides, the Agency would
not require Tier I nontarget organisms and Tier II environmental fate
data. For example, under this approach, the Agency would not receive
any exposure or infectivity/pathogenicity data for biochemical
pesticides. For microbial pesticides, the Agency would significantly
reduce the

frequency of time (up to 50 percent) that proposed Tier I nontarget
organisms and Tier II environmental fate data are required. The
nontarget organism tests monitor the effects of proposed pesticides on
nontarget birds, wild mammals, fish, insects and plants. The
environmental fate tests are used to assess the persistence of
biochemicals and microbial pesticides in the environment. This option
would only minimally reduce the regulatory burden as compared to the
changes being proposed today (described in Option 3). The Agency does
not believe the decrease in burden outweighs the loss in benefits to
public health and the environment from reduced availability of data for
assessing environmental hazard and risk through registration decisions.
The cost savings realized in this option are only marginally lower than
the savings realized in the proposed option.
    2. Option 2 (significant regulatory burden, adequate risk
assessment). This high-cost approach was evaluated based on an Agency
approach of maximizing the completeness of the database. Under this
approach, the Agency would require Tier I human health and
environmental data requirements 100 percent of the time. For example,
under this approach, the Agency would receive all exposure and
infectivity/pathogenicity data, with immunotoxicity required as Tier II
and Tier III data. This approach would result in significantly higher
costs to pesticide registrants and increased burden to the Agency
compared to the proposed approach. Additionally, unlike Option 1 and
the proposed option, EPA believes that this high-cost approach would
substantially raise the cost of registering a biochemical or microbial
pesticide, resulting in fewer products being registered and reducing
the potential for these biopesticides (generally lower risk) to compete
in the marketplace to provide alternatives to conventional pesticides
(generally higher risk). The extra cost and time required to register a
biochemical or microbial pesticide under this option may discourage use
of these safer pesticides, resulting in more, not less environmental
risk.
    3. Option 3 (proposed option). The proposed option provides the
Agency with flexibility and is a middle ground between Option 1,
representing a minimal cost but potentially significant loss of
environmental hazard information, and Option 2, representing the
maximum availability of information, but at significantly higher cost.
The Agency would require, under certain conditions, human health and
environmental data from all tiering levels (I, II, III, IV). The
frequency that data is required would be based on current scientific
knowledge and conditions specific to the active ingredient and use
patterns. For example, the Agency proposes to require immunotoxicity as
Tier II and Tier III data, conditionally require infectivity/
pathogenicity data, and conditionally require exposure data for insect
repellents. The proposed option is a codification of current practice,
and is a balance that provides sufficient data for Agency to complete
an environmental risk assessment while ensuring the lowest feasible
cost and burden to applicants and the Agency.
    The Agency believes the changes proposed today best serve to
protect human health and the environment and allow for a complete and
accurate assessment of risks, while benefitting a large number of
parties, including the regulated industry, pesticide users, the general
public, other Federal, State, and foreign governments, and others who
are affected by or interested in pesticide use or regulation.
Additionally, the net benefit of the proposed changes is expected to
include a cost savings for existing and future biochemical and
microbial pesticide registrants versus the current codified
requirements.
    Comparing the proposed option to Option 1 (low cost option), EPA
believes that the modified and newly-imposed nontarget organisms and
environmental fate Tier I data requirements contained in the proposed
approach are needed to ensure informed risk assessment and risk
management decisions on biochemical and microbial pesticide
registrations.
    Comparing the proposed option to Option 2 (high cost option), EPA
believes that the cost and burden of requiring the Tier I human health
and environmental data for all biochemical and microbial registrations
would not warrant the modest benefits of marginally valuable
information. EPA believes that Option 2 would reduce the adverse
externalities of pesticides and unknown risks to consumers only
slightly more than the proposed approach. However, the benefits of this
additional data are speculative. Based on the specific nature and
scientific knowledge of biochemical and microbial pesticides, these
additional data (over and above what the proposed option requires)
would most likely inform registration decisions very little.

XV. References

    The Agency has established a docket for this rulemaking under
docket ID number EPA-HQ-OPP-2004-0415. The following is a listing of
the documents that are specifically referenced in this proposed rule.
These documents, and other supporting materials, are included in the
docket. Please note that the official docket includes the documents
located in the docket as well as the documents that are referenced in
those documents. As indicated previously, not all docket materials are
available electronically, but all publicly available docket materials
are available as described under ADDRESSES.
    1. U.S. EPA, 2005. ``Summary of Proposed Changes to Biochemical and
Microbial Pesticide Data Requirements.'' FEAD/OPP/U.S. EPA, Washington,
D.C.
    2. U.S. EPA, 2003. ``OPPTS Test Guidelines.'' OPP/U.S. EPA,
Washington, D.C.
    3. National Research Council, ``Pesticides in the Diets of Infants
and Children,'' National Academy Press, Washington, D.C., 1993. Excerpt
pp. 152-156.
    4. FIFRA Scientific Advisory Panel (SAP). 1994 SAP Final, November
29, 1994 FIFRA Scientific Advisory Panel Meeting, November 29-30, 1994,
held in Arlington, Virginia.
    5. U.S. EPA. 2005. Part II. Environmental Protection Agency.
Pesticides; Data Requirements for Conventional Pesticides; Proposed
Rule. (70 FR 12276, March 11, 2005).
    6. U.S. EPA, 2005. ``Economic Analysis of the Proposed Rule
Changing Data Requirements for Biochemical and Microbial Pesticides.''
FEAD/OPP/U.S. EPA, Washington, D.C.
    7. FIFRA Scientific Advisory Panel (SAP). ``A Set of Scientific
Issues Being Considered by the Agency in Connection with Proposed
Revision to Subdivision M, Immunotoxicity Testing of Biochemical Pest
Control Agents (BPCA's).'' Review from open meeting on March 24, 1987
in Arlington, Virginia.
    8. U.S. EPA, 1989. ``Subdivision M of the Pesticide Testing
Guidelines, Microbial and Biochemical Pest Control Agents.'' EFED/OPP/
U.S. EPA, Washington, D.C.
    9. U.S. EPA, 1982. ``Pesticide Assessment Guidelines, Subdivision
M, Biorational Pesticides.'' HED/OPP/U.S. EPA, Washington, D.C.
    10. U.S. EPA, 1986. ``Series 875, Group A, Applicator/user Exposure
Monitoring Guidelines.'' Presented to the FIFRA Scientific Advisory
Panel (SAP), January, 1986. OPP/U.S. EPA, Washington, D.C.
    11. U.S. EPA, 2005. ``Overview of Proposed Data Requirements and
FIFRA SAP Review.'' FEAD/OPP/U.S. EPA, Washington, D.C.
    12. U.S. EPA, 2005. ``Analysis of Data Requirements for Biochemical
and

Microbial Pesticides from 1997-2004.'' FEAD/OPP/U.S. EPA, Washington,
D.C.
    13. U.S. EPA, 2005. ``Data Requirements for Biochemical and
Microbial Pesticides; Proposed Rule; Consultations.'' FEAD/OPP/U.S.
EPA, Washington, D.C.
    14. U.S. EPA, 2005. ``Comparison between Current Conventional
Pesticides Data Requirements and Proposed Biochemical and Microbial
Pesticide Data Requirements.'' FEAD/OPP/U.S. EPA, Washington, D.C.
    15. OECD [2002-a] Guidance for Registration Requirements for
Pheromones and Other Semiochemicals Used for Arthropod Pest Control.
OECD Series on Pesticides, Number 12. Organization for Economic
Cooperation and Development. February 26, 2002.
    16. U.S. EPA, 2000. ``p-Menthane-3,8-diol (011550) Biopesticide
Registration Eligibility Document.'' BPPD/OPP/U.S. EPA, Washington,
D.C. Issued May, 2000.
    17. OECD [2002-b] Registration of Agricultural Pesticides,
Biological Pesticides--Progress on Development of Dossier/Monograph
Guidance for Microbials and Pheromones. Working Group on Pesticides.
Organization for Economic Cooperation and Development. January 3, 2002.
    18. U.S. EPA, 2002. ``Supporting Statement for an Information
Collection Request: Tolerance Petitions for Pesticides on Food/Feed
Crops and New Inert Ingredients.'' OMB Control No. 2070-0024, EPA ICR
No. 0597. OPP/U.S. EPA, Washington, D.C.
    19. U.S. EPA, 2002. ``Supporting Statement for an Information
Collection Request: Application for New or Amended Pesticide
Registration.'' OMB Control No. 2070-0060, EPA ICR No. 0277. OPP/U.S.
EPA, Washington, D.C.
    20. U.S. EPA, 2001. ``Supporting Statement for an Information
Collection Request: ''Data Generation for Reregistration; Phase 4 and 5
Reregistration.`` OMB Control No. 2070-0107, EPA ICR No. 1504. OPP/U.S.
EPA, Washington, D.C.
    21. U.S. EPA, 2001. ``Supporting Statement for an Information
Collection Request: Data Call-Ins for the Special Review and
Registration Review Programs.'' OMB Control No. 2070-0057, EPA ICR No.
0057. OPP/U.S. EPA, Washington, D.C.
    22.U.S. EPA, 2004. ``Supporting Statement for an Information
Collection Request: Plant- Incorporated Protectants; CBI Substantiation
and Adverse Effects Reporting.'' OMB Control No. 2070-0142, EPA ICR No.
1693, Washington, D.C.
    23. U.S. EPA, 2005. Protections for Subjects in Human Research:
Final Rule. (71 FR 6138, February 6, 2006). Document ID No. OPP-2003-
0132.

XVI. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), the Agency submitted a
draft of this proposed regulation to the FIFRA SAP, the USDA, the
Committee on Agriculture in the House of Representatives, and the
Committee on Agriculture, Nutrition, and Forestry in the United States
Senate.
    The FIFRA SAP waived its review of this proposal because the
significant scientific issues involved have already been reviewed by
the SAP and additional review isn't necessary. USDA participated fully
in the interagency review process under Executive Order 12866, during
which EPA and USDA discussed the registration process of microbial
pesticides and the need for a coordination process when an APHIS
movement permit under 7 CFR part 340 is required by USDA. As a part of
related comments, USDA suggested that the Agency consider requiring the
registrants to submit a copy of the applicable APHIS permits as part of
the registration application for a microbial pesticide because it would
facilitate coordination and improve compliance with the applicable USDA
requirements. As discussed in Unit IIX., the Agency is specifically
seeking public comment on the most appropriate method to ensure APHIS
permitting and EPA registrations are properly coordinated.

XVII. Regulatory Assessment

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this proposed rule is a ``significant
regulatory action'' because the proposed revision of the existing
regulation to update the data requirements may raise novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
Accordingly, EPA submitted this proposed rulemaking to OMB for review
under Executive Order 12866 and any changes made in response to OMB
comments have been documented in the docket for this rulemaking as
required by sec. 6(a)(3)(E) of the Executive Order.
    In addition, EPA has prepared an economic analysis of the potential
costs, benefits, and impacts associated with this proposed action,
which is contained in a document entitled Economic Analysis of the
Proposed Rule Changing Data Requirements for Biochemical and Microbial
Pesticides (Ref. 6). A copy of this Economic Analysis is available in
the docket for this action, and is briefly summarized here.
    The economic analysis considered the incremental effects between
the baseline and future biochemical and microbial pesticide
registration activity based on the proposed rule and two alternatives.
All costs associated with presently codified 40 CFR part 158 data
requirements applicable to biochemical and microbial pesticides were
considered in the baseline. Future biochemical and microbial
registration activity and associated costs were calculated based on a
historical examination of actual pesticide registration actions between
1997 and 2004 combined with anticipated effects of new, revised, or
modified 40 CFR part 158 subparts L and M data requirements. Review of
1997 to 2004 registration activity considered the type and frequency of
the various biochemical and microbial pesticide registration actions
that occurred, the related applicability of the various data
requirements for those actions, the type and regularity of waivers
granted by EPA for certain data requirements, and information about the
applicants involved in those actions. Where applicable, these trends
and patterns were used to predict future registration activity.
Additional effects of the proposed rule due to newly proposed, revised,
or modified 40 CFR part 158 subparts L and M data requirements were
estimated based on EPA experience and best judgment.
    Most of the data requirements contained in this proposal have been
applied on a case-by-case basis over the years to reflect the evolution
of scientific understanding and concerns. The proposed revisions
include newly codified data requirements (i.e., data requirements that
are not currently in part 158, but have been, in practice, required on
a case-by-case basis), changes to existing requirements (i.e., a change
in frequency with which a currently codified data requirement would be
imposed. For example, a change from conditionally-required to required,
or visa versa, or a change in use pattern for an existing requirement),
and newly imposed data requirements (i.e., data requirement have never
been previously imposed).
    To calculate the potential costs associated with this proposal, EPA
first identified the tests necessary to generate the data required, and
then gathered information on the prices that laboratories typically
charge a firm to conduct these tests. The prices varied

depending on conditions specific to the substance tested. Variations
can be related to differences in the assumptions about the test
performed (e.g., protocol, species used), or can simply be a difference
in the price charged by the laboratory. Average, high, and low cost
estimates were obtained for each test where possible. EPA assumed that
the data required would always need to be newly generated, but often
the data are already available because the registrant generated it for
its own use. In such cases, the firm would simply need to submit those
data to EPA, which involves less burden than generating it.
    EPA then used historical data on pesticide registration actions
that occurred over an eight year period (1997-2004) to identify the
entities that sought pesticide registration actions in the past (Ref.
12). The data required for each registration action depends on several
factors, including the type of registration action (e.g., registration
of a new active ingredient food use, registration of a new active
ingredient non-food use, registration and amendments to registrations
involving a major new use) and use pattern (how the product will be
used). To estimate the average incremental cost of a new registration,
a baseline testing rate (i.e., the percentage of time a particular test
was historically required under the current rule) was estimated by EPA
scientists based on their past experience with biochemical and
microbial pesticide registrations and their involvement in developing
the new data requirements. This baseline data requirement rate was
compared with the percentage of time each test was required for
registrations between 1997 and 2004. EPA assumes that under the
proposed rule, data requirements would be imposed at the same frequency
they have been required from 1997 to 2004. Additionally, EPA scientists
estimated the frequency that newly imposed data requirements would be
required.
    Part of the Economic Analysis included preparation of an industry
profile using the same historical data on pesticide registration
actions to identify the companies involved in those actions, and based
it on public information gathered about those companies. EPA also used
this industry profile to analyze the potential impacts of the proposed
rule on small businesses, the results of which are summarized in Unit
XVII.C. The incremental costs and a more detailed discussion of the
estimating methodology employed in the analysis are presented in the
economic impact analysis prepared for this proposed rule (Ref. 6).
    Using the currently codified requirements as the baseline for the
impact analysis, the total annual impact to the pesticide industry is
estimated to be a regulatory compliance cost reduction of about $3.04
million per year, with an estimated average cost reduction of $60,000
per firm per year.
    EPA also considered a low cost alternative and a high cost
alternative to the proposed rule. The low cost alternative would waive
certain data requirements for biochemical pesticides and reduce the
rate at which certain data requirements are required for microbial
pesticides. The estimated impact of the low cost alternative is
estimated to be a regulatory compliance cost reduction approximately
$3.20 million, with an estimated average cost reduction of $63,000 per
firm per year. The high cost alternative would require certain groups
of data requirements 100 percent of the time, removing the discretion
of Agency scientists to decide if the data are needed for a specific
registration. This alternative would result in an estimated annual cost
increase over current rule requirements of approximately $3.44 million
per year, or an estimated cost increase of $67,000 per firm.
    The estimated potential costs of the proposed rule acknowledges
registrant is likely to request that the Agency waive certain data
requirements if the registrant believes that the data are not necessary
for determining the effects of a pesticide on human health and the
environment. EPA estimated the annual cost savings due to waived data
requirements based on both the historical rate and type of waivers
granted for the period from 1997-2004, and on an analysis of how the
proposed rule is expected to modify the rate at which waivers are
granted. EPA estimated that the annual cost savings due to waived data
requirements based on the historic waiver rates to be approximately
$29.6 million, or $580,000 per firm per year. At the modified waiver
rates predicted under the proposed rule, EPA estimated an annual cost
savings of $23.96 million, or $470,000 per firm per year.
    Since the likely impact of the proposed rule on businesses overall
is expected to be mostly beneficial, the Agency believes that the rule
would have no effect on the availability of pesticides to users. On
balance, the Agency believes that cost savings resulting from the
proposed changes to 40 CFR part 158 subparts L and M can be realized
without compromising the protection of human health and the
environment.

B. Paperwork Reduction Act

    This proposed rule does not contain any information collection
requirements that require additional approval by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. Pursuant to the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person
is not required to respond to an information collection request unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations contained in Title 40 of the CFR, after
appearing in the preamble of the final rule, may be listed in 40 CFR
part 9, and included on the related collection instrument (e.g., form
or survey).
    Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to: review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
    EPA has determined that this proposed rule imposes no additional
information collection and paperwork burden. The information collection
requirements, i.e., the paperwork collection activities, contained in
this proposal related to the new data necessary to register a pesticide
product are already approved by OMB under several existing information
collection requests (ICR). Specifically, the program activities which
would generate a paperwork burden under this proposal are covered by
the following ICRs:
    The activities associated with the establishment of a tolerance are
currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597)
(Ref. 18);
    The activities associated with the application for a new or amended
registration of a pesticide are currently approved under OMB Control
No. 2070-0060 (EPA ICR No. 0277) (Ref. 19);
    The activities associated with the generation of data for
reregistration are currently approved under OMB Control

No. 2070-0107 (EPA ICR No. 1504) (Ref. 20);
    The activities associated with the generation of data for special
review or registration review are currently approved under OMB Control
No. 2070-0057 (EPA ICR No. 0922) (Ref. 21); and
    Notification of genetically modified microbial pesticides. OMB
Control No. 2070-0142 (EPA ICR No. 1693) (Ref. 22).
    These existing ICRs cover the paperwork activities contained in
this proposal because these activities already occur as part of
existing program activities. These program activities are an integral
part of the Agency pesticide program and the corresponding ICRs are
regularly renewed as required under the PRA, such that these OMB
Control Nos. are maintained valid. The approved burden in these ICRs
were increased in 1996 to accommodate the potential increased burden
related to the implementation of the new safety standard imposed in
1996 by FQPA and additional burden revisions related to the proposed
rule are not necessary.
    Based on these existing approvals, the Agency estimates that the
total average annual public reporting burden currently approved by OMB
for these various activities ranges from 8 hours to approximately 3,000
hours per respondent, depending on the activity and other factors
surrounding the particular pesticide product. Additional information
about this estimate is provided in the Economic Analysis for this
rulemaking.
    Direct your comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, to EPA using the docket that has been
established for this proposed rule (docket ID number EPA-HQ-OPP-2004-
0415) at http://www.epa.gov/edocket/.

    The Agency will consider and address comments received on the
information collection requirements contained in this proposal when it
develops the final rule.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., after considering the potential economic impacts
of today's proposed rule on small entities, the Agency hereby certifies
that this proposal will not have a significant adverse economic impact
on a substantial number of small entities. This determination is based
on the Agency's economic analysis performed for this rulemaking, which
is summarized in Unit XVII.A., and a copy of which is available in the
docket for this rulemaking. The following is a brief summary of the
factual basis for this certification.
    Small entities include small businesses, small organizations, and
small governmental jurisdictions. For purposes of assessing the impacts
of today's proposed rule on small entities, small entity is defined in
accordance with the RFA as: (1) A small business as defined by the
Small Business Administration's (SBA) regulations at 13 CFR 121.201;
(2) a small governmental jurisdiction that is a government of a city,
county, town, school district, or special district with a population of
less than 50,000; and (3) a small organization that is any not-for-
profit enterprise which is independently owned and operated and is not
dominant in its field.
    Based on the industry profile that EPA prepared using historical
data as part of the Economic Analysis prepared for this rulemaking, EPA
has determined that this proposed rule is not expected to impact any
small not-for-profit organizations or small governmental jurisdictions.
As such, the small entity impacts analysis prepared as part of the
economic analysis evaluated potentially impacted businesses that could
be considered small businesses as defined by the Small Business
Administration, which uses the maximum number of employees or sales for
businesses in each industry sector, as that sector is defined by NAICS.
For example, entities defined as Pesticide and Other Agricultural
Chemical Manufacturing (325320) are considered to be a small business
if they employ 500 or fewer people.
    EPA then used historical data to estimate the impacts of the
proposed rule on these small businesses. Out of 51 firms with
biochemical or microbial registration actions between 1997 to 2004,
financial data for determining company size was available for 40 firms,
with 23 of those firms classified as small businesses. According to the
analysis, all of these small entities would have realized a reduction
in costs based on the proposed rule changes compared to the current
part 158 data requirements. Given these estimated impacts on small
businesses, EPA concluded that the proposed revisions may benefit and
would not likely have a significant adverse economic impact on a
substantial number of small entities.
    Nonetheless, EPA is particularly interested in receiving comment
from small businesses as to the estimated cost savings, expected
benefits, and overall impacts of this proposed rule. Any comments
regarding the economic impacts that this proposed regulatory action may
impose on small entities should be submitted to the Agency in the
manner specified in the ADDRESSES section.

D. Unfunded Mandates Reform Act

    Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and tribal governments, in the
aggregate, or the private sector in any one year. As described in Unit
XVII, the total annual impact to the pesticide industry is estimated to
be a regulatory compliance cost reduction of about $3.04 million per
year. In addition, since State, local, and tribal governments are
rarely a pesticide applicant or registrant, the proposed rule is not
expected to significantly or uniquely affect small governments.
    Accordingly, this action is not subject to the requirements of
sections 202 and 205 of UMRA.

E. Federalism Implications

    Pursuant to Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999), EPA has determined that this proposed rule
does not have ``federalism implications,'' because it would not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in the Order. Because instances where a State is a registrant
are extremely rare, this proposed rule may seldom affect a State
government. Thus, Executive Order 13132 does not apply to this proposed
rule. In the spirit of the Order, and consistent with EPA policy to
promote communications between the Agency and State and local
governments, EPA specifically solicits comment on this proposed rule
from State and local officials.

F. Tribal Implications

    As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000), EPA has determined that this proposed rule does not have tribal
implications because it would not have substantial direct effects on
tribal governments, on the relationship between the Federal government
and the Indian tribes, or on the distribution

of power and responsibilities between the Federal government and Indian
tribes, as specified in the Order. At present, no tribal governments
hold, or have applied for, a pesticide registration. Thus, Executive
Order 13175 does not apply to this proposed rule. In the spirit of the
Order, and consistent with EPA policy to promote communications between
the Agency and tribal governments, EPA specifically solicits comment on
this proposed rule from tribal officials.

G. Protection of Children

    Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) does not apply to this proposed rule because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XVII.A.). Further, this
proposal does not establish an environmental standard that is intended
to have a negatively disproportionate effect on children. To the
contrary, this action would provide added protection for children from
pesticide risk. The proposed data requirements are intended to address
risks that, if not addressed, could have a disproportionate negative
impact on children. EPA would use the data and information obtained by
this proposed rule to carry out its mandate under FFDCA to give special
attention to the risks of pesticides to sensitive subpopulations,
especially infants and children.

H. Energy Implications

    This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001) because it is not
likely to have any significant adverse effect on the supply,
distribution, or use of energy.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures, etc.) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This regulation
proposes the types of data to be required to support conventional
pesticide registration but does not propose to require specific methods
or standards to generate those data. Therefore, this proposed
regulation does not impose any technical standards that would require
Agency consideration of voluntary consensus standards. The Agency
invites comment on its conclusion regarding the applicability of
voluntary consensus standards to this rulemaking.

J. Environmental Justice

    This proposed rule does not have an adverse impact on the
environmental and health conditions in low-income and minority
communities. Therefore, under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994), the Agency has
not considered environmental justice-related issues.

List of Subjects

40 CFR Part 158
    Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Reporting and recordkeeping requirements.
40 CFR Part 172
    Confidential business information, Pesticides and pests, Reporting
and recordkeeping requirements, Administrative practice and procedure,
Agricultural commodities, Intergovernmental relations, Labeling.

    Dated: March 1, 2006.
Stephen L. Johnson,
Administrator.
    Therefore, it is proposed that 40 CFR chapter I, parts 158 and 172
be amended as follows:

PART 158--[AMENDED]

    1. By revising the authority citation for part 158 to read as
follows:

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

    2. By adding Sec.  158.3 to part 158, subpart A to read as follows:

Sec.  158.3  Definitions.

    All terms defined in sec. 2 of the Federal Insecticide, Fungicide,
and Rodenticide Act apply to this part and are used with the meaning
given in the Act. Applicable terms from the Federal Food, Drug, and
Cosmetic Act also apply to this part. Individual subparts may contain
definitions that pertain solely to that subpart. The following
additional terms apply to this part:
     Active ingredient means any substance (or group of structurally
similar substances, if specified by the Agency) that would prevent,
destroy, repel or mitigate any pest, or that functions as a plant
regulator, desiccant, defoliant, or nitrogen stabilizer, within the
meaning of FIFRA section 2(b).
    End-use product means a pesticide product whose labeling:
    (1) Includes directions for use of the product (as distributed or
sold, or after combination by the user with other substances) for
controlling pests or defoliating, desiccating or regulating growth of
plants, or as a nitrogen stabilizer, and
    (2) Does not state that the product may be used to manufacture or
formulate other pesticide products.
    Formulation means: (1) The process of mixing, blending, or dilution
of one or more active ingredients with one or more other active or
inert ingredients, without an intended chemical reaction, to obtain a
manufacturing-use product or an end-use product, or
    (2) The repackaging of any registered product.
     Impurity means any substance (or group of structurally similar
substances if specified by the Agency), in a pesticide product other
than an active ingredient or an inert ingredient, including unreacted
starting materials, side reaction products, contaminants, and
degradation products.
     Impurity associated with an active ingredient means:
    (1) Any impurity present in the technical grade of active
ingredient; and
    (2) Any impurity which forms in the pesticide product through
reactions between the active ingredient and any other component of the
product or packaging of the product.
     Inert ingredient means any substance (or group of structurally
similar substances if designated by the Agency), other than the active
ingredient, which is intentionally included in a pesticide product.
     Integrated system means a process for producing a pesticide
product that:
    (1) Contains any active ingredient derived from a source that is
not an EPA-registered product; or
    (2) Contains any active ingredient that was produced or acquired in
a manner that does not permit its inspection by the Agency under FIFRA
sec. 9(a) prior to its use in the process.
    Manufacturing-use product means any pesticide product other than an
end-use product. A product may consist of the technical grade of active

ingredient only, or may contain inert ingredients, such as stabilizers
or solvents.
    Starting material means a substance used to synthesize or purify a
technical grade of active ingredient (or the practical equivalent of
the technical grade ingredient if the technical grade cannot be
isolated) by chemical reaction.
     Technical grade of active ingredient means a material containing
an active ingredient:
    (1) Which contains no inert ingredient, other than one used for
purification of the active ingredient; and
    (2) Which is produced on a commercial or pilot plant production
scale (whether or not it is ever held for sale).

Sec.  158.65  [Removed]

    3. By removing Sec.  158.65.
    4. By adding subparts L and M to part 158 to read as follows:
Subpart L--Biochemical Pesticides
Sec.
158.900 Biochemical pesticides subject to subpart L.
158.910 Biochemical pesticides data requirements.
158.930 Product chemistry data requirements table.
158.940 Residue data requirements table.
158.950 Human health assessment data requirements table.
158.960 Nontarget organisms and environmental fate data requirements
table.
158.970 Biochemical pesticides product performance data
requirements.
Subpart M-- Microbial Pesticides
Sec.
158.1000 Definition and applicability.
158.1010 Microbial pesticide data requirements.
158.1020 Product analysis data requirements table.
158.1030 Residue data requirements table.
158.1040 Toxicology data requirements table.
158.1050 Nontarget organisms and environmental fate data
requirements table.
158.1060 Microbial pesticides product performance data requirements.

Subpart L--Biochemical Pesticides

Sec.  158.900  Biochemicalpesticides subject to subpart L.

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

Sec.  158.910   Biochemicalpesticides data requirements.

    (a) Sections 158.930 through 158.970 identify the data requirements
that are required to support registration of biochemical pesticides.
Variations in the test conditions are identified within the test notes.
Definitions that apply to all biochemical data requirements can be
found inSec.  158.930.
    (b) Each data table includes ``use patterns'' under which the
individual data are required, with variations including food and
nonfood uses for terrestrial and aquatic applications, greenhouse,
indoor, forestry, and residential outdoor applications under certain
circumstances.
    (c) The categories for each data requirement are ``R'', which
stands for required, and ``CR'' which stands for conditionally
required. If a bracket appears around the R or CR, the data are
required for both the registration and experimental use permit
requests. Generally, ``R'' indicates that the data are more likely
required than forthose data requirements with CR. However, in each
case, the regulatory text preceding the data table and the test notes
following the data table must be used to determine whether the data
requirement must be satisfied.
    (d) Each table identifies the test substance that is required to be
tested to satisfy the data requirement. Test substances may include:
technical grade active ingredient (TGAI), manufacturing-use product
(MP), end-use product (EP), typical end-use product (TEP), residue of
concern, and pure active ingredient (PAI) or (All) indicating all of
the above. Commasbetween the test substances (i.e., TGAI, EP) indicate
that data may be required on the TGAI or EP or both depending on the
conditions set forth in the test note. Data requirements which list two
test substances (i.e., TGAI and EP) indicate that both are required to
be tested. Data requirements that list only the manufacturing product
(MP) as the test substance apply toproducts containing solely the
technical grade of the active ingredient and manufacturing-use products
to which other ingredients have been intentionally added. Data
requirements listing the EP as the test substance apply to any EP with
an ingredient in the end-use formulation other than the active
ingredient that is expected to enhance the toxicity of the product.
    (e) The data requirements are organized into a tier-testing system
with specified additional studies at higher tiers being required if
warranted by adverse effects observed in lower tier studies. The lower
tier studies are a subset of those required for conventional
pesticides, and the studies overall are generally selected from those
required for conventional pesticides.
    (f) Two sets of guideline numbers are provided for some of the
environmental fate data requirements. For ease of understanding, the
current guidelines will be used as an interim measure until the new
guidelines (in parentheses) are finalized.

Sec.  158.930   Product chemistrydata requirements table.

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

                                                 Table--Biochemical Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Test Substance  to support
          Guideline Number               Data Requirement       All Use  Patterns   ----------------------------------------------       Test notes
                                                                                MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                              Product identity and   [R]                      TGAI, MP               TGAI, EP               1,2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
 880.1200                             Description of         [R]                      TGAI, MP               TGAI, EP               2,3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
 880.1400                             Discussion of          [R]                      TGAI and MP            TGAI and MP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1700                             Preliminary analysis   [CR]                     TGAI and MP            TGAI and MP            5,8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1750                             Certified limits       [R]                      MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.1800                             Enforcement            [R]                      MP                     EP                     7
                                      analytical method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6302                             Color                  [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6303                             Physical state         [R]                      TGAI                   TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6304                             Odor                   [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6313                             Stability to normal    [R]                      TGAI                   TGAI                   8,17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6315                             Flammability           [CR]                     MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6317                             Storage stability      [R]                      MP                     EP                    --
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6319                             Miscibility            [CR]                     MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.6320                             Corrosion              [R]                      MP                     EP                    --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7000                             pH                     [CR]                     TGAI and MP            TGAI and EP            8,11
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7050                             UV/Visible light       [R]                      TGAI                   TGAI                  --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7100                             Viscosity              [CR]                     MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7200                             Melting point/melting  [CR]                     TGAI                   TGAI                   8,13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7220                             Boiling point/boiling  [CR]                     TGAI                   TGAI                   8,14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------

 830.7300                             Density/relative       [R]                      TGAI and MP            TGAI and EP            8,18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7520                             Particle size, fiber   [CR]                     TGAI                   TGAI                   8,15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7550                             Partition coefficient  [CR]                     TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7840                             Water solubility       [R]                      TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
 830.7950                             Vapor pressure         [R]                      TGAI                   TGAI                   8,19
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

Sec.  158.940  Residue datarequirements table.

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

                                             Table--Biochemical Residue Data Requirements for Specific Uses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Use patterns containing data requirements
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test notes
                                                ------------------------------------  Greenhouse Food     Indoor Food
                                                     Food/Feed            Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          [CR]              [CR]              [CR]              [CR]             TGAI             1,2,4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    [CR]              [CR]              [CR]              [CR]             TGAI             1,3,4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     [CR]              [CR]              [CR]              [CR]             TGAI             1,4,5,6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     [CR]              [CR]              [CR]              [CR]             TGAI             1,7,8,10
                                residue in
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                     Residue           CR                CR                R                 [CR]             Residue of       4,9,10
                                analytical                                                                               concern
                                method- plants
                               Residue
                                analytical
                                method-
                                livestock.
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                     Multiresidue      CR                CR                R                 CR               Residue of       10,11
                                method                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                [CR]              NR                NR               TGAI             1,12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                [CR]              NR                NR               TGAI             1,13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                [CR]              NR                NR               TGAI             1,14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                [CR]             TGAI             1,15
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        [CR]              [CR]              [CR]              [CR]             TGAI or plant    1,7,8,10
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        [CR]              [CR]              [CR]              [CR]             TGAI             1,3,4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   [CR]              [CR]              [CR]              [CR]             TGAI             1,16
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       [CR]              [CR]              [CR]              [CR]             Residue of       1,10,17
                                residues                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          [CR]              [CR]              [CR]              [CR]             Residue of       1,18
                                tolerances                                                                               concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        [CR]              [CR]              [CR]              [CR]             Residue of       1,10
                                grounds in                                                                               concern
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      [CR]              [CR]              [CR]              [CR]             TGAI             10,19
                                analytical
                                reference
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical residue for specific uses as referenced in
the last column of the table contained in paragraph (d) of this
section.
    1. Residue chemistry data requirements apply to biochemical
pesticide products when Tier II or Tier III toxicology data are
required, as specified for biochemical agents in the biochemical
human health assessment data requirements, Sec.  158.950.
    2. The same chemical identity data are required for biochemical
product chemistry data requirements,Sec.  158.930 with an emphasis
on impurities.
    3. Required information includes crops to be treated, rate of
application, number and timing of applications, preharvest
intervals, and relevant restrictions.
    4. Residue data for outdoor residential uses are required if
home gardens are to be treated and the home garden use pattern is
different from use patterns where tolerances have been established.
    5. Required unless it is an arthropod pheromone applied at a
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied
directly to food, in order to determine metabolites and/or
degradates.
    7. Data on metabolism in livestock are required when residues
occur on a livestock feed or if the pesticide is to be applied
directly to livestock. If results from the plant metabolism study
show differing metabolites in plants from those found in animals, an
additional livestock metabolism study involving dosing with the
plant metabolite(s) may also be required.
    8. Livestock feeding studies are required whenever a pesticide
residue is present in livestock feed or when direct application to
livestock uses occurs.
    9. A residue method suitable for enforcement of tolerances is
required whenever a numeric tolerance is proposed.
    10. Required for indoor uses if the indoor use could result in
pesticide residues in or on food or feed.

    11. Data are required to determine whether FDA/USDA multiresidue
methodology would detect and identify the pesticides and any
metabolites.
    12. Data on residues in potable water are required whenever a
pesticide is to be applied directly to water, unless it can be
determined that the treated water would not be used (eventually) for
drinking purposes, by man or animals.
    13. Data on residues in fish are required whenever a pesticide
is to be applied directly to water inhabited, or that will be
inhabited, by fish that may be caught or harvested for human
consumption.
    14. Data on residues in irrigated crops are required when a
pesticide is to be applied directly to water that could be used for
irrigation or to irrigation facilities such as irrigation ditches.
    15. Data on residues in food/feed in food handling
establishments are required whenever a pesticide is to be used in
food/feed handling establishments.
    16. Data on the nature and level of residue in processed food/
feed are required when detectible residues could concentrate on
processing.
    17. Anticipated residue data are required when the assumption of
tolerance level residues would result in predicted exposure at an
unsafe level of exposure. Data on the level or residue in food as
consumed would be used to obtain a more precise estimate of
potential dietary exposure.
    18. The proposed tolerance must reflect the maximum residue
likely to occur in crops in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.

Sec.  158.950  Human healthassessment data dequirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the human health assessment data
requirements for a particular pesticide product.
    (2) The data in this section (158.950) are not required for
straight chain lepidopteran pheromones when applied up to a maximum use
rate of 150 grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include
products classified under the following general uses: terrestrial food
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse
food crop use.
    (2) Nonfood use patterns include products classified under the
general use patterns of terrestrial nonfood crop use; aquatic nonfood
residential use; aquatic nonfood outdoor use; aquatic nonfood
industrial use; greenhouse nonfood crop use; forestry use; residential
outdoor use; residential indoor use; indoor food use; indoor nonfood
use; indoor medical use.
    (c) Key. R=Required; [R]=Required for registrations and
experimental use permits; CR=Conditionally required; [CR]=Conditionally
required for registrations and experimental use permits; NR=Not
required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical
end-use product; TGAI=Technical grade of the active ingredient; Residue
of concern= the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All= all of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
biochemical human health assessment. The test notes are shown in
paragraph (e) of this section.

                                              Table--Biochemical Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                      Test substance to support
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          [R]                 [R]                 TGAI and MP>        TGAI and EP         1
                                   toxicity-rat
--------------------------------------------------------------------------------------------------------------------------------------------------------