product is exempt from registration requirements. Prior to registering
a pesticide product, EPA must first ensure that the pesticide, when
used according to label directions, can be used without posing
unreasonable risks to humans and the environment. The registration of a
pesticide product, whether it is an antimicrobial or other type of
pesticide product, is considered an ``action'' subject to the
Endangered Species Act (ESA). The ESA requires all Federal agencies to
ensure that any action they permit or authorize will not result in
likely jeopardy to the continued existence of endangered or threatened
species, or destroy or adversely modify habitat designated as critical
by the U.S. Fish and Wildlife Service (FWS) or National Marine
Fisheries Service (NMFS).
    In order to ensure EPA's actions are consistent with the ESA, the
Agency must assess the potential for both direct and indirect effects
to any potentially exposed threatened or endangered species and
critical habitat, independent of whether exposure results from a point-
source discharge or the slow release of a pesticide containing
material. If effects may occur, EPA consults with the FWS or NMFS to
determine whether there may be jeopardy to the species or destruction
or adverse modification to habitat designated as critical.

B. Method for Conducting Endangered Species Assessments

    1. Comment. A commenter claimed that EPA/OPP does not have a mature
program currently in place for antimicrobial environmental risk
assessment generally. More specifically, the commenter contended that
EPA does not have a program in place for assessing potential impacts on
endangered and threatened species relevant to antimicrobials and their
uses. The commenter argued that until EPA scientifically substantiates
data requirements to use in estimating antimicrobial environmental
exposures and modeling and the potential for risks from such exposures,
it will not be feasible to make any meaningful determinations on
potential impacts to endangered species. The commenter concluded that
it is thus premature for the EPA to determine how it should approach
antimicrobials with regard to endangered species.
    2. EPA's response. EPA disagrees with the commenter. EPA has a
robust program for completing antimicrobial environmental risk
assessments, as outlined in the preamble to the proposed rule (73 FR
59405). Environmental fate studies evaluate the mobility, distribution
and dissipation of a pesticide in various compartments of the
environment, such as water, soil, air, and sediment. Ecological effects
data are used by the Agency to determine the toxicological hazards of
pesticides to various nontarget organisms, such as birds, mammals,
fish, bees, terrestrial and aquatic invertebrates, and plants. The
required environmental fate studies and ecological effects (both plant
and animal) data provide the foundation for an environmental risk
assessment. EPA's environmental risk assessment for antimicrobials
combines environmental fate studies with ecological effects data to
determine the potential of the pesticide to cause harmful effects to
nontarget organisms and plants. The data requirements that will be
codified in the final rule will provide sufficient information for EPA
to perform an ecological risk assessment.
    EPA/OPP's process for assessing the potential risks of a pesticide
to federally-listed threatened or endangered species and their
designated critical habitat is described in the document titled
``Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs, U.S. Environmental Protection Agency--Endangered
and Threatened Species Effects Determinations'' (Ref. 13). Appendix A
to that document--``Overview of OPP's Screening-Level Ecological Risk
Assessment Process for Antimicrobial Pesticides''--explains both the
data needed and the process that would be used by EPA to assess
potential risks to endangered and threatened species from antimicrobial
pesticides.
    EPA's assessment of potential impacts on endangered and threatened
species begins with a screening level assessment to determine if there
is a potential concern. When the screening-level ecological risk
assessment raises potential concerns related to a listed species, EPA
then conducts a species-specific evaluation to refine the assessment.
The more refined assessment should involve clear delineation of the
action area associated with the proposed use of the pesticide and best
available information on the temporal and spatial co-location of the
listed species with respect to the action area. EPA notes that with the
publication of the proposed rule, the discussion in Appendix A is out
of date. In response to comments received on the proposed antimicrobial
data requirements, EPA indicated it is no longer relying on its
proposed approach classifying use patterns as high/low or minimal/
significant exposure uses with regard to ecological effects testing.
However, the Agency's basic approach to endangered species risk
assessments, which combine environmental fate studies with ecological
effects data to determine the potential of the pesticide to cause
harmful effects to endangered species, has not changed. In addition,
the Agency will conduct an assessment for antimicrobial pesticides with
down-the-drain uses, as described in response to comment 134.1 in the
Response to Comments Document in the docket. The codified data
requirements and the down-the-drain assessment will extend EPA's
Antimicrobial Division's ability to understand the potential impacts of
antimicrobial pesticides on endangered species.

    EPA cannot wait to comply with the ESA until newer, more advanced,
models are available or additional data needs are determined. Federal
agencies must comply with the ESA by performing their assessments and
analyses using the best scientific and commercial data available. As a
part of Registration Review, EPA is conducting species-specific
environmental risk assessments that will allow EPA to determine whether
the antimicrobial pesticide product has ``no effect'' or ``may affect''
federally-listed threatened or endangered species (listed species) or
their designated critical habitats. When an assessment concludes that a
pesticide product's use ``may effect'' a listed species or its
designated critical habitat, the Agency will consult with the FWS and/
or NMFS, as appropriate.

XX. Endocrine Disruption

    This unit summarizes the significant public comments and EPA's
response to those comments. A more detailed discussion can be found in
the Response to Comments Document available in the docket to this rule.
    1. Comment. The commenters noted that EPA did not include any
studies to assess endocrine disruption effects.
    2. EPA's response. The commenter is correct that EPA did not
include, within proposed part 158, subpart W, studies whose sole
purpose is to assess endocrine disruption effects in avian and aquatic
species. The Agency is also not including such studies in this final
rule.
    With regards to toxicology data requirements, as required by FIFRA
and FFDCA, EPA reviews a toxicological data base of numerous studies to
assess potential adverse outcomes from exposure to chemicals.
Collectively, these studies include acute, subchronic and chronic
toxicity, including assessments of carcinogenicity, neurotoxicity,
developmental, reproductive, and general or systemic toxicity. These
studies include endpoints which may be susceptible to endocrine
influence, including effects on endocrine target organ histopathology,
organ weights, estrus cyclicity, sexual maturation, fertility,
pregnancy rates, reproductive loss, and sex ratios in offspring. EPA
reviews these data and selects the most sensitive endpoints for
relevant risk assessment scenarios from the existing toxicological data
base.
    With regards to ecotoxicity data requirements, as required by FIFRA
and FFDCA, EPA reviews a nontarget organism data base of numerous
studies to assess potential adverse outcomes from exposure to
chemicals. For ecological hazard assessments, EPA evaluates acute tests
and chronic studies that assess growth, developmental and reproductive
effects in different taxonomic groups. EPA reviews these data and
selects the most sensitive endpoints for relevant risk assessment
scenarios from the existing nontarget organism database.
    Through a separate effort, the Agency has also developed a
screening battery to identify chemicals that may have effects on the
hormone systems of humans and wildlife. As required under FFDCA section
408(p), the Agency developed the Endocrine Disruptor Screening Program
(EDSP) to determine whether certain substances (including pesticide
active and other ingredients) may have an effect in humans or wildlife
similar to an effect produced by a ``naturally occurring estrogen, or
other such endocrine effects as the Administrator may designate.'' The
EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier I consists of a battery of 11 screening assays to
identify the potential of a chemical substance to interact with the
estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals
that go through Tier I screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next
stage of the EDSP where EPA will determine which, if any, of the Tier 2
tests are necessary based on the available data. Tier 2 testing is
designed to identify any adverse endocrine-related effects caused by
the substance, and establish a dose-response relationship between the
dose and the E, A, or T effect.
    Between October 2009 and February 2010, EPA issued test orders/data
call-ins for 58 pesticide active ingredients and 9 inert ingredients.
This list of chemicals was selected based on the potential for human
exposure through pathways such as food and water, residential activity,
and certain post-application agricultural scenarios. This list should
not be construed as a list of known or likely endocrine disruptors.
    Under FFDCA section 408(p) the Agency must screen all pesticide
chemicals, including antimicrobials. Accordingly, EPA anticipates
issuing future EDSP test orders/data call-ins for all pesticide active
ingredients.
    For further information on the EDSP including the status and test
guidelines, please visit the Web site: http://www.epa.gov/endo/.

XXI. Effective Date of Final Antimicrobial Data Requirements

    This unit summarizes the significant public comments and EPA's
response to those comments. A more detailed discussion can be found in
the Response to Comments Document available in the docket to this rule.
    1. Comment. Several commenters have expressed concern over when the
final rule would take effect. One commenter stated that compliance with
the Administrative Procedures Act requires EPA to apply any final
rulemaking on data requirements for antimicrobials only to applications
submitted after the effective date; otherwise, EPA would be
promulgating the final rule retroactively. The commenter also asserted
that EPA should be consistent in its implementation of effective dates,
noting that EPA did not impose new data requirements on pending
conventional pesticide registrants when the conventional pesticide
rules were revised. A second commenter suggested that registrations
pending at the time of the final rule publication be given conditional
registration under section 3(c)(7) of FIFRA or under section 3(c)(5) if
the requirements of part 161 have been met, and that implementation of
the part 158, subpart W data requirements occur at the time of periodic
registration review. Another commenter noted that EPA has provided
reasonable notice to registrants and recommends that EPA implement the
rule as soon as technically feasible. A different commenter questioned
whether additional Pesticide Registration Improvement Act (PRIA)
registration fees would be required for pending applications if the
registrant did not meet new data requirements and withdrew the
application, or if the Agency issued a determination that it cannot
grant the application.
    2. EPA's response. EPA will follow an approach similar to that used
for conventional pesticides following the promulgation of that portion
of 40 CFR part 158.
    As previously discussed, the final rule for antimicrobials contains
11 ``new'' data requirements. ``New'' means that the data requirement
has never been required, or has rarely been required on a case-by-case
basis and has not been routinely considered during the Agency's
evaluation of the data needed for the purpose of risk assessment. The
new data requirements being codified include eight that were proposed
and three that have been added based on public comments received about
the proposed rule.

    EPA recognizes that during early implementation of 40 CFR part 158,
subpart W not all application packages may have all of the newly-
required data. Therefore during early implementation of 40 CFR part
158, subpart W, EPA will accept for review and evaluation application
packages that may not have all of the newly required data in
appropriate cases supported by adequate justification. This early
implementation period could extend up to 2 years post-promulgation for
situations in which a more time-intensive new study is missing but
could be less for other situations, such as for less time-intensive new
studies. The applicant should address the issue of timing (i.e., why
the data are not yet submitted and when the data can be submitted) with
respect to any missing newly-required data, in their justification.
    EPA is statutorily required to evaluate the proposed pesticide
thoroughly to ensure that it will not unreasonably harm human health or
the environment. For pesticides needing FFDCA section 408 tolerances,
EPA is statutorily required to make a safety finding that the pesticide
can be used with ``reasonable certainty of no harm.'' In cases where
the application may not have all the required data, EPA would evaluate
whether a registration determination or a safety finding can be made
based on the available data or on the results of other studies in the
pesticide's data base. If there is insufficient information, and if the
data base does not provide information on the endpoints that would be
tested, or data provided by the applicant or information in the data
base shows evidence of effects, EPA may not be able to make a
registration decision or safety finding. In such cases, the application
may be denied or the applicant may choose to withdraw the application
pending completion of the needed data. In some cases, conditional
registrations may be appropriate for consideration. Among other things,
a determination that the proposed use will not significantly increase
the risk of unreasonable adverse effects on the environment will need
to be made. If EPA can make that determination and the other elements
for a conditional registration are met, then a conditional registration
may be appropriate and the new data required as a condition of
registration. If there is a basis for granting a conditional
registration, then the timeframe for conditioning the registration
would be determined based on factors such as the required studies
involved and the length of time required to conduct those studies.
    Importantly, it should be noted that acceptance of an application
for processing during early implementation of 40 CFR part 158, subpart
W, that does not result in a conditional registration, does not
permanently relieve the applicant from providing the newly required
data. Based on the particular case involved, the Agency will employ
appropriate mechanisms, for example, through a data call-in or through
the registration review process, to ensure the generation and
submission of any missing newly-required data.
    With respect to pending applications that are withdrawn, additional
Pesticide Registration Improvement Act (PRIA) registration fees will
generally only be required if the applicant seeks to pursue the action
again by submitting a new application (and addressing the deficiencies
in the original application). In withdrawal situations, the Agency
provides a refund for any work that the Agency did not perform on the
application following a withdrawal. Similarly, a determination that the
application cannot be granted does not require additional PRIA
registration fees. In that case, additional fees will only be incurred
if the application is subsequently withdrawn or denied, and the
applicant seeks to pursue the action again and submits a new
application.

XXII. Economic Analysis

    This unit summarizes the significant public comments and EPA's
response to those comments. A more detailed discussion can be found in
the Response to Comments Document available in the docket to this rule.

A. Comparing Estimates of Cost of the Proposed Rule

    1. Comment. A commenter performed an independent economic analysis
(EA) for the proposed rule. According to the commenter's analysis, the
cost of proposed part 158, subpart W is greater than that estimated by
the EPA. In addition, the unit test costs and frequency of tests used
in the commenter's analysis are different than EPA's.
    2. EPA's response. EPA reviewed the commenter's analysis and based
on that review revised the EA for the final rule. EPA's evaluation of
the commenter's EA indicated there were the following differences
between the two EAs:
     The cost estimates used for the studies,
     Overhead costs were included by the commenter, but not by
EPA,
     Costs for Registration Review (see Unit XXII.C.).

The differences between the cost of the proposed rule as estimated by
the commenter and the cost as assessed by the Agency for new
registrations are explained in the following subunits.
    i. How data requirement costs are calculated. The annual cost of a
data requirement is the product of three factors: Unit test cost,
probability of the test being required, and the number of registrations
in the industry per year for the registration type and use. That is:
``Industry cost of a data requirement = Unit test cost x test
probability x number of registrations.'' These costs are summed for all
data requirements, uses, and registration types to get the total annual
cost of the data requirements for the industry.
    ii. Differences in unit test costs. EPA acknowledges that there are
significant differences between the Agency's analysis and the
commenter's analysis regarding the unit test costs. According to the
commenter's EA, the costs were provided to them by their client's
technical consultants, and are ``based on quotes from laboratories,
actual experience, and professional judgment.'' The commenter did not
provide sufficient information with which to evaluate the commenter's
test cost estimates. Additionally, EPA notes that having all test cost
estimates ending in zero could be indicative of estimation.
    EPA's unit test costs for each data requirement were obtained by
contacting established contract research organizations (CROs) to assess
what the labs would charge to conduct studies according to specific
designs provided by EPA, or as specified in OPPTS guidelines (now OCSPP
guidelines). Upper and lower cost estimates were requested. For each
test, the upper cost estimates from each CRO were averaged to obtain a
high average estimate. A similar calculation was done for the lower
cost estimate. EPA's estimate is the average of the high and low
average estimates.
    iii. Test costs and overhead costs. The commenter added 30 percent
to their test cost estimates to account for the overhead of the
registrants managing and overseeing the tests they contract to the
labs. EPA acknowledges that there are costs other than test costs
associated with registering and maintaining the registrations of
pesticide products. Overhead is not a new cost, attributable to the
rule, and EPA does not believe that overhead costs will change
significantly as a result of codifying data requirements for
antimicrobials. EPA does not include overhead costs in its economic
analyses of data requirements rules because the Agency accounts for
other registration costs such as overhead

in the Information Collection Request (ICR) for FIFRA Section 3
Registration under the Paperwork Reduction Act.
    iv. Test probabilities. EPA's test probabilities (the probabilities
of tests being required for a registration action) were based on a
sample of 70 actual antimicrobial registration actions out of 90
relevant new registration actions during the 6 year period beginning
2000 and ending 2005, supplemented with EPA's scientific judgment. The
time period (2000-2005) was chosen for EPA's EA because the analysis in
the EA was started in 2006. The commenter claims to have based the test
probabilities used to make their estimates on a sample of 29
registration review cases (not new registrations) occurring between
2008 and 2010.
    v. Factors which drive costs for new registrations. To determine
the influence of the previously-discussed factors on the difference
between the commenter's and EPA's estimates, EPA performed the
following analysis on the data requirements costs and incremental costs
using the same unit test costs and test probabilities used in the
proposed rule:
     To account for the effect of the unit test costs on the
data requirements costs and incremental costs, EPA substituted the
commenter's unit test costs without overhead into EPA's analysis of the
proposed rule using EPA's test probabilities and number of
registrations. If there were no changes, this would indicate that the
test costs were not driving the differences in estimates.
     To account for the effect of test probabilities and number
of registrations, EPA substituted the commenter's unit test costs with
overhead into EPA's analysis. In this case, the difference between the
EPA's and the commenter's analysis is contained in the test
probabilities and number of registrations. If there were no changes,
this would indicate that the test probabilities and number of
registrations were not driving the differences between the two
analyses. Since the commenter includes overhead in their analysis,
overhead was included in this comparison to make other things equal so
that the differences in test probabilities and number of registrations
could be isolated.
    vi. Results. The results of the factor analysis are presented in
the following Table 1.

                 Table 1--Comparison of Data Requirement Costs and Factors for New Registrations
----------------------------------------------------------------------------------------------------------------
             Factors                       A                   B                   C                   D
----------------------------------------------------------------------------------------------------------------
Unit Test Costs according to:...  EPA Proposed Rule.  Commenter without   Commenter with 30   Commenter with 30
                                                       overhead.           percent overhead.   percent overhead.
Test Probabilities according to:  EPA...............  EPA...............  EPA...............  Commenter.
Number of Registrations           EPA...............  EPA...............  EPA...............  Commenter.
 according to:
Data Requirement Cost according   $15.0.............  $19.9.............  $25.5.............  $25.9.
 to Proposed Rule ($ millions).
Cost of Proposed Rule             $3.9..............  $7.6..............  $9.8..............  $9.2.
 (Incremental Costs) ($
 millions).
----------------------------------------------------------------------------------------------------------------

    Column A exhibits the data requirements and incremental costs from
EPA's EA of the proposed rule. In column B, the data requirements and
incremental costs are calculated using the commenter's unit test costs
without overhead costs, but EPA's test probabilities and number of
registrations. Column C is the same as column B, but with overhead
costs included. Finally, column D exhibits the data requirements and
incremental costs with overhead as calculated by the commenter.
    The result of the first factor analysis is demonstrated by
comparing column A to column B. In this case, the difference between
the two columns is the unit test costs. Inserting the commenter's unit
test costs, without overhead, into the cost estimates with EPA's test
probabilities and number of registrations leads to over a 30 percent
increase in data requirements cost and a nearly 100 percent increase in
incremental costs.
    The result of the second factor analysis is demonstrated by
comparing columns C and D. In this case, the difference between the two
columns is in the test probabilities and number of registrations. While
individual test probabilities may be different in EPA's and the
commenter's analyses, the overall effect of the products of test
probabilities and number of registrations, when summed with the unit
test costs, including overhead, are similar in both of these analyses.
The resulting differences in data requirements cost and incremental
costs are less than 2 percent and about 6 percent, respectively.
Therefore, EPA concludes that any differences in test probabilities and
number of registrations used as input parameters in the calculations do
not have a significant effect on the total data requirement cost of new
registrations.
    Comparisons across columns A, B, and C also provide information on
the portion of the cost difference accounted for by overhead costs.
Columns A, B, and C compare the cost of data requirements using the
unit test cost estimates of EPA and those of the commenter with and
without overhead. The overhead costs account for more than one-half of
the difference in the total cost of the data requirements, but less
than 40 percent of the difference in incremental costs (the incremental
cost is the increase in costs between the baseline (the existing data
requirements in part 161) and proposed part 158, subpart W).
    From this comparison, EPA makes the following conclusions. First,
differences in test probabilities and number of registrations do not
have a significant impact on the cost of the rule. Second, even if EPA
and the commenter used the same probabilities and test costs, inclusion
of overhead costs by the commenter would result in a 30 percent
difference in costs. Finally, when the overhead costs are removed from
the commenter's analysis, differences in unit test costs between EPA
and the commenter account for most of the differences in the estimates
of the cost of the rule for new registrations.
    vii. Revised test costs. In light of the results of the comparison
between EPA's and the commenter's EA, EPA sought to verify its unit
test cost estimates. To examine the costs submitted by ACC, EPA
resurveyed the cost of conducting studies for 30 data requirements: The
criteria for selecting which test's cost to update included how the
difference in estimates would impact on the cost of the rule, the
magnitude of the differences in estimates, and the age and source of
EPA's estimates. EPA's data gathering

methodology is reproducible, and based on actual data. EPA does not
adjust the lab's cost estimates, i.e., the costs are used as obtained
from the laboratory. Under the Information Quality Act (IQA), EPA must
ensure and maximize the quality, objectivity, utility, and integrity of
the data used in its analyses.
    The resurveyed test costs are used in the EA for the final rule.
EPA is using its cost estimates because it has revised its most
relevant and oldest unit test cost estimates. In addition, the
commenter did not provide a basis or sufficient explanation that would
meet the standards of the IQA to justify EPA's accepting the
commenter's costs. For additional information see response to comment
40.1 in the Response to Comments Document and the final economic
analysis, both in the docket.

B. Impact on Small Businesses

    1. Comment. A commenter claimed that EPA underestimated costs, is
not fully complying with the Regulatory Flexibility Act (RFA) and the
Small Business Regulatory Enforcement Fairness Act (SBREFA), and must
prepare an Initial Regulatory Flexibility Assessment (IRFA). In
addition, the commenter argued that small businesses will be adversely
affected, that there will be an ``increased disparity between
registrants and a more uneven playing field,'' and finally, that a
SBREFA analysis should have been conducted.
    2. EPA's response. EPA acknowledges that the cost of the data
requirements would likely be a larger percentage of a small business's
revenues, but did not find that the rule would have a significant
adverse economic impact on a substantial number of small firms.
    A regulatory flexibility analysis examines the type and number of
small entities potentially subject to the rule, recordkeeping and
compliance requirements, and significant regulatory alternatives, among
other things. RFA, as amended by SBREFA, requires EPA to consider the
economic impact of proposed rules on small entities. RFA requires EPA
to prepare an IRFA for each proposed rule, when the rule will have a
significant economic impact on a substantial number of small entities.
    To comply with RFA, EPA did a retrospective analysis of what the
additional costs would have been on actual new registrations if the
proposed rule had been in effect during 2000-2005. This analysis did
not indicate a significant impact on a substantial number of small
entities; instead, the analysis indicated that 5 percent of small firms
(25 out of 500) are likely to experience some impact and only 2.8
percent of small firms (14 out of 500) are likely to experience an
economic impact of 3 percent or more of gross sales. Based on this
analysis, EPA certified that the proposed rule would not have a
significant adverse economic impact on a substantial number of small
firms. As a result, EPA did not have to conduct an IRFA nor convene a
SBREFA Panel for the proposed part 158, subpart W rule.
    In the EA for the final rule, EPA reestimated the SBREFA analysis
with revised unit test costs and changes in data requirements.
     About 23 small firms (almost 5 percent) are likely to
experience an economic impact of 3 percent or more of gross sales, and
     About 26 small firms, (over 5 percent) are likely to
experience an economic impact of 1 percent or more of gross sales.
    Hence, had these results been estimated at the proposal stage, EPA
would still have concluded that there would not be a significant impact
on a substantial number of small entities.

C. Cost of New Data Requirements on Registration Review

    1. Comment. A commenter stated that EPA has not accurately stated
the potential costs and benefits, as required by Executive Order (EO)
12866. In particular, EPA has not included the impact of incremental
costs of new data requirements on registration review, or the cost of
consultations. The commenter also claims that under the Paperwork
Reduction Act (PRA), EPA should include the paperwork burden costs of
registration review for existing registrants.
    2. EPA's response. EO 12866 requires the Agency to submit to OMB
for review significant regulatory actions. EPA complied with EO 12866
during 2008 by submitting drafts of both the economic analysis and the
proposed rule to OMB. The changes that were made to the proposed rule
as the result of OMB's review were included in the docket for the
proposed rule. The Agency notes that one purpose of soliciting comments
on the economic analysis at the proposal stage is to get input on where
the Agency might improve the economic analysis.
    The commenter is not correct in asserting that EPA did not include
the impact of incremental costs. The Agency has captured the
anticipated costs necessary for complying with the regulations. See the
final Economic Analysis (Ref. 1) in the docket for a more detailed
discussion, particularly sections 5.3 and 5.5.
    The commenter is correct in that the costs of fulfilling the 11
``new'' data requirements during registration review were not
considered in the Agency's economic analysis of the proposed part 158,
subpart W data requirements. EPA agrees with the commenter that
registrants of existing antimicrobial products will incur costs during
registration review. In fact, EPA relied on the 2005 EA conducted for
the Registration Review Rule. When registration review was proposed,
EPA prepared an economic analysis of that program, which estimated the
cost of data requirements and paperwork burden according to what would
likely be required in registration review for existing registrants. The
2005 registration review EA estimate of data requirement costs for
existing antimicrobial pesticides was based on what would likely be
required for a sample of antimicrobial active ingredients. This would
have included all tests that would have been required at that time,
i.e., those in current practice whether or not in part 158.
    However, proposed part 158, subpart W included ``new'' tests, which
were not anticipated when the economic analysis of the registration
review process was completed. In a final economic analysis for part
158, subpart W, EPA addresses the additional registration review costs
for these 11 ``new'' studies, as well as other changes from the
proposed rule to the final rule, including changes made as a result of
the comments received. The incremental impact for Registration Review
is $ 6.8 million.
    The commenter is also correct that EPA did not include the cost of
consultation in its economic analysis. Consultations are longstanding,
commonly used, and valuable processes in EPA's Pesticide Program and
are beneficial to both EPA and the applicants. However, consultations
are not mandatory, and based on comments received EPA has removed all
references to consultations from the final data requirements tables.
See Unit V.C. for additional information on the use and purpose of
consultations.

XXIII. References

    As indicated under ADDRESSES, a docket has been established for
this rulemaking under docket ID number EPA-HQ-OPP-2008-0110. The
following is a listing of the documents that are specifically
referenced in this proposed rule. The docket includes these documents
and other information considered by EPA in developing this rule,
including documents that are referenced within the documents that are
included in the docket, even if the referenced document is not
physically

located in the docket. For assistance in locating documents, please
consult the technical contact listed under FOR FURTHER INFORMATION
CONTACT.

    1. USEPA, Final Economic Analysis of Changes in Data
Requirements for Antimicrobial Pesticides, (March 13, 2013).
    2. USEPA, ``Data Requirements for Pesticide Registration; Final
Rule'' (49 FR 42856, October 26, 2007)(FRL-8106-5).
    3. ACC Biocides Panel; ``Regulation of Antimicrobials that are
Indirect or Secondary Direct Food Additives;'' (February 2, 2006).
    4. CMA Biocides Panel; ``Comments on EPA's September 17, 1999
Proposed Rule on Registration Requirements for Antimicrobial
Pesticide Products and Other Pesticide Regulatory Changes for
Codification; (January 18, 2000).
    5. ACC Biocides Panel; Memorandum to Frank Sanders, ``EPA's
Current Interpretation of the Antimicrobial Reform Technical
Corrections Act and Section 2(bb) of FIFRA is Inconsistent with the
Statutes;'' (November 3, 2000).
    6. ACC Biocides Panel; ``EPA/FDA Jurisdiction for Food Contact
Antimicrobials;'' (July 17, 2003).
    7. Grizzle, Charles L.; representative of Albright & Wilson
Americas, Inc., letter to Lynn R. Goldman; (September 11, 1997).
    8. ChemReg International, L.L.C.; Tiered Testing for Risk
Assessment of Antimicrobial Pesticides; (September 12, 2002).
    9. Goldberg, Seth; ``Section 2(bb) of FIFRA; Dual Jurisdiction
Over Food Contact Antimicrobials; (April 27, 2001).
    10. ACC Biocides Panel; ``Comments on The Preliminary Risk
Assessment for 1,4-Bis(bromoacetoxy)-2-butene (BBAB);'' (August 6,
2001).
    11. ACC Biocides; Hasmukh C. Shah letter to Frank T. Sanders;
(August 3, 2000).
    12. Edwards, Deborah; OPP Response to CropLife letter of May 29,
2009; (June 26, 2009).
    13. Overview of the Ecological Risk Assessment Process in the
Office of Pesticide Programs, U.S. Environmental Protection Agency--
Endangered and Threatened Species Effects Determinations (January
2004) (see www.epa.gov/espp/consultation/ecorisk-overview.pdf).
    14. Portier; SAP Waiver; (April 4, 2011).

XXIV. FIFRA Review Requirements

    In accordance with FIFRA section 25(a), a draft of this final rule
was submitted to the FIFRA SAP. EPA requested the FIFRA SAP to waive
its review of the final rule based on the fact that the SAP, in 2008,
had waived review of the proposed rule. The final rule does not contain
any new scientific issues warranting additional review by the SAP. The
SAP waived its review on April 4, 2011, stating that ``[t]he final rule
does not contain scientific issues that the Panel has not previously
considered'' (Ref. 14).
    In accordance with FIFRA section 25(a), EPA has submitted a draft
of the final rule to the appropriate Congressional Committees and the
Secretary of the Department of Agriculture. There were no comments in
response to these submissions.
    In accordance with FIFRA section 21(b), EPA submitted a draft of
the final rule to the Secretary of Health and Human Services (HHS), and
their comments were reviewed and addressed in this final rule.

XXV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action'' because the Office of
Management and Budget (OMB) determined that this action might 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 action to OMB for review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any
changes made in response to OMB recommendations have been documented in
the docket for this action as required by Executive Order 12866.
    EPA has prepared an EA of the potential costs associated with this
action, entitled ``Final Economic Analysis of Changes in Data
Requirements for Antimicrobial Pesticides'' (Ref. 1), a copy of which
is in the docket. This final EA evaluates the potential benefits and
costs expected as a result of registrations and registration reviews.
The EA is briefly summarized here.
    In its analysis, the Agency considered the potential, additional
costs for the registration of new antimicrobial pesticides or new uses
of currently registered antimicrobial pesticides, as well as the
potential, additional costs incurred during the registration review of
existing antimicrobial pesticides.
    Based on comments received during the public comment period, the
following changes were made to the rulemaking, and are therefore
reflected in the final EA:
     One proposed data requirement will not be codified: Non-
dietary ingestion exposure. The test cost is $75,000. In the proposed
rule, EPA expected to receive the test 0.8 times per year, representing
an annual industry savings of $63,125.
     EPA revised certain of the data requirements from ``NR''
or ``CR'' to ``R,'' or vice-versa.
    Based on comments received, three new data requirements were added:
Simulation test to assess the biodegradability of chemicals discharged
in wastewater, simulation test--aerobic sewage treatment: Activated
sludge units, and nature of the residue on surfaces. The rationale for
these three new studies is described in Unit III.B.
    The estimated costs for both registration review and for a
registration action for the three newly-required data requirements are:
    1. Simulation tests to assess the biodegradability of chemicals in
discharged wastewater and simulation test--aerobic sewage treatment:
activated sludge units. Both of these studies are used as part of the
down-the-drain analysis for antimicrobials. The studies are
conditionally required for all use patterns, except for the aquatic
areas use pattern, for which the study is not required. EPA does not
have an estimate for the cost of either of these studies; instead, for
the EA, EPA used the value $33,000, which is the cost of the porous pot
test. The Agency expects, however, that the cost of the simulation
tests will be less than this amount. For registration review, EPA
expects to receive the porous pot test or one of the simulation tests
up to 8.5 times per year, for an annual industry cost of $280,500. For
new registrations, EPA expects to receive either of the studies up to
7.5 times per year, for an annual industry cost of $247,500. The total
annual cost is $528,000.
    2. Nature of residue on surfaces. This test is part of the residue
chemistry data requirements, and is conditionally required for all use
pattern categories. The test cost is $95,000. For registration review,
EPA expects to receive this test 1.3 times per year, for an annual
industry cost of $118,750. For new registrations, EPA expects to
receive this test up to 0.5 times per year, for an annual industry cost
of $44,333. The total annual cost is $163,083.
    Many test notes for data requirements were revised based on
comments received. Data requirements for certain use patterns were
changed from ``NR'' or ``CR'' to ``R,'' while others were changed from
``R'' to ``CR.'' Because the cost of the rule depends, in part, on the
probabilities of the tests being required, these revisions have
resulted in a modification of the cost of the rule. Instead of
estimating the cost of each change individually, the Agency reestimated
the potential cost of the regulation as a whole, taking into account
the changes discussed previously.
    Based on comments received, EPA has updated the unit test costs for
30

selected tests. The criteria for selecting which test's cost to update
included:
     How changing the cost estimates would impact on the cost
of the rule,
     The magnitude of the difference between EPA's cost
estimate and the commenters' cost estimate, and
     The length of time since EPA's cost estimate was last
updated.
    EPA estimated the annual cost of registering a new antimicrobial
pesticide or new use of currently-registered antimicrobial pesticides,
taking into account both the changes in data requirements and in unit
test costs. Both the total annual industry costs and the newly-imposed
costs were estimated. The updated test costs plus exposure and other
test costs revisions since the proposed rule increased the cost of the
rule by about 23 percent compared to the proposed rule. The estimated
total annual industry costs of the final rule is expected to be about
$19.3 million, which is approximately 29 percent higher than the cost
of the proposed rule. The difference between the baseline costs (the
existing data requirements that were codified in 1984) and the cost of
the Agency's current practices is about $1 million annually. The
difference between the baseline costs and the final rule costs, i.e.,
the incremental costs, is approximately $8.2 million annually. Under
the final rule, the average cost per registration action of a new
antimicrobial active ingredient is approximately $1 million to $5
million.
    For existing chemicals, data requirements in part 158, subpart W
are relevant to the registration review program which began to replace
the reregistration program in 2006 as a means of systematically
reevaluating existing registrations against the standards of FIFRA.
    EPA has evaluated the impact of the data requirements being
codified in this final rule on registrants of existing chemicals
undergoing registration review whose active ingredient data bases do
not contain all of the new data requirements. The average additional
cost of registration review as a result of the new data requirements is
estimated to be about $588,000 for wood preservatives, $284,000 for
food and indirect food uses, and $260,000 for all other uses. For
registration review, the total annual cost is $6.8 million.
    As required, EPA conducted an analysis of the impact of this final
rule on small businesses, as discussed in the Unit XXV.C.

B. Paperwork Reduction Act (PRA)

    The information collection requirements contained in this rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. At the time of the proposed rule, EPA prepared a supporting
statement for amending an ICR, entitled ``Data Requirements for
Antimicrobial Pesticides (Proposed Rule)'' and identified by EPA ICR
No. 2318.01, a copy of which is in the docket.
    Under 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.
    The information collection activities related to the submission of
data to EPA in order to register, amend or retain a new or existing
pesticide product or obtain a tolerance for that product are already
approved by OMB under PRA. As such, the supporting statement only
addresses the proposed changes to the data requirements that impact the
information collection activities related to antimicrobial pesticides.
The procedures for submitting data to EPA under FIFRA and FFDCA are not
changed in this proposal, and are already approved by OMB in the
following ICRs:
    1. Tolerance ICR. Data Submission Activities Associated with
Tolerance Actions (currently approved under OMB Control No. 2070-0024
(EPA ICR No. 0597));
    2. Registration ICR. Data Submission Activities Associated with the
Application for a New or Amended Registration of a Pesticide (currently
approved under OMB Control No. 2070-0060 (EPA ICR No. 0277)); and
    3. Reregistration, Special and Registration Review ICR. Data
Submission Activities Associated with the Generation of Data for
Special Review or Registration Review (currently approved under OMB
Control No. 2070-0174 (EPA ICR No. 2288)).
    These three program activities are an integral part of the Agency's
pesticide program, including antimicrobial pesticides, and the
corresponding ICRs are regularly renewed every 3 years as required by
PRA. The total estimated average annual public reporting burden
currently approved by OMB for these various activities range from 8
hours to approximately 3,000 hours per respondent, depending on the
activity and other factors surrounding the particular pesticide
product.
    In the supporting statement the Agency estimates that the typical,
current annual paperwork burden for registrants per antimicrobial
pesticide registration is 194 burden hours and $12,631. The total
annual registrant paperwork burden and costs for data submission
activities for antimicrobial pesticides applicants and registrants will
be updated accordingly in the ICRs specified in this discussion during
the next, appropriate ICR renewal cycle.
    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, or is otherwise required to submit
the specific information by a statute. The OMB control numbers for
EPA's regulations codified in Title 40 of the Code of Federal
Regulations, after appearing in the preamble of the final rule, are
further displayed either by publication in the Federal Register or by
other appropriate means, such as on the related collection instrument
or form, if applicable. The display of OMB control numbers for certain
EPA regulations is consolidated in a list at 40 CFR 9.1.

C. Regulatory Flexibility Act (RFA)

    The RFA, 5 U.S.C. 601 et seq., generally requires an Agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act, 5 U.S.C. 551-553, or any other statute unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small organizations and small governmental jurisdictions.
    For purposes of assessing the impacts of this final rule on small
entities, small entity is defined as:
    1. A small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR 121.201, which is based on
either the maximum number of employees or on the sales for small
businesses in each industry sector, as defined by a 6-digit NAICS code,
and for this rule is a producer of pesticide products (NAICS 32532),
antifoulants (NAICS 32551), antimicrobial pesticides (NAICS 32561) or
wood preservatives (NAICS 32519), importers of such products, or any
person or company who seeks to register an antimicrobial, antifoulant
coating, ballast water treatment, or wood preservative pesticide or to
obtain a tolerance for such a pesticide;
    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; or
    3. A small organization that is any not-for-profit enterprise which
is independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this final rule on small

entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. The factual
basis for the Agency's determination is presented in the small entity
impact analysis prepared as part of the Economic Analysis for this
final rule (Ref. 1), and is summarized in this unit.
    EPA has determined that this rulemaking does not impact any small
governmental jurisdictions or any small not-for-profit enterprise
because these entities are rarely pesticide applicants or registrants.
As such, EPA has assessed the impacts on small businesses. Some of the
small entities directly regulated by this rulemaking are in the
pesticide and other agricultural chemical manufacturing industry sector
(NAICS code 325320). Firms in this sector are considered small under
the SBA definition if they employ 500 or fewer people. The economic
analysis for the final rule specifies the NAICS code used for each of
the firms analyzed.
    EPA estimates that 750 unique parent companies constitute the total
universe of pesticide antimicrobial registrants. Of these, based on the
SBA definition of a small business and the available sales data for
these firms, EPA estimates that 500, or approximately 67 percent,
qualify as a small business. When considering both registration review
and new registrations, on average each year about 30 small businesses
would have incurred additional costs under this rule. EPA estimates
that:
     About 23 small firms (almost 5 percent of the 500 small
antimicrobial firms) subject to this regulation are likely to
experience an economic impact of 3 percent or more of gross sales,
     About 3 small firms (0.6 percent of the 500 small
antimicrobial firms) subject to this regulation are likely to
experience an economic impact of greater than 1 percent but less than 3
percent of sales revenues, and
     About 3 small firms (0.6 percent of the 500 small
antimicrobial firms) subject to this regulation are likely to
experience an economic impact of greater than 0 percent, but less than
1 percent of sales revenues.
    In addition, there are also opportunities for small entities to
lower their potential costs. The proposed data requirements in many
instances are tiered, with higher-tiered testing triggered on the
results of lower-tiered testing. EPA encourages registrants to consult
with the Agency to ensure that only the required data is submitted. If
available, open literature or the same tests on similar products, or
alternative means to meet data requirements, such as QSAR, can be
submitted for Agency consideration. Some firms may have surrogate data
or they may share the cost of generating data. These may present
opportunities for cost savings by small entities, and all other
applicants as well, while allowing the Agency to fulfill its role of
making pesticide regulatory decisions that protect the general
population, sensitive sub-populations, and the environment.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of UMRA, 2 U.S.C. 1531-1538, establishes requirements for
Federal agencies to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. EPA has
determined that this final rule 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 XXV.A., the incremental costs for this
final rule is estimated at approximately $8.3 million (for registration
actions) and $6.8 million (for registration review) per year for the
private sector, which is below the $100 million threshold. Since State,
local, and tribal governments are rarely pesticide applicants, this
rule is not expected to significantly or uniquely affect small
governments, nor does this rule contain any regulatory requirements
that might significantly or uniquely affect small governments.
Accordingly, this rule is not subject to the requirements of sections
202 and 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. As stated
previously, State, local, and tribal governments are rarely pesticide
applicants.

E. Executive Order 13132: Federalism

    This action does not have federalism implications, because it will
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 Executive Order 13132 (64 FR 43255, August 10, 1999).
Since States or local governments are rarely pesticide applicants or
registrants, this final rule would seldom affect a State or local
government. Thus, Executive Order 13132 does not apply to this rule.
    In the spirit of Executive Order 13132 and consistent with EPA
policy to promote communication between EPA, and State and local
governments, EPA specifically solicited comment on the proposed rule
from State and local officials. EPA did receive comments on substantive
parts from local sanitation districts and associations representing
their interests. Their comments are addressed in the Response to
Comments Document in the docket, and, as appropriate, revisions were
made for the final rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Government Implications

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). At present, no
tribal government holds, or has applied for, a pesticide registration.
Thus, Executive Order 13175 does not apply to this action. In the
spirit of the Order, and consistent with EPA policy to promote
communications between the Agency and Indian tribes, EPA specifically
solicited comment on the proposed rule from tribal officials. No
comments were received.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
final rule is not subject to Executive Order 13045 because it is not
economically significant as defined by Executive Order 12866, and
because the Agency does not have reason to believe the environmental
health or safety risks addressed by this action present a
disproportionate risk to children. This rule does not propose an
environmental standard that is intended to have a negatively
disproportionate effect on children. To the contrary, this rule is
intended to provide added protection to children from antimicrobial
pesticide risk. EPA will use the data and information obtained by this
action to carry out its mandate under FFDCA to give special attention
to the risks of pesticides to sensitive groups in early lifestages,
especially infants and children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This final rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001) because it is not likely to

have any adverse effect on the supply, distribution, or use of energy.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of 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 otherwise impractical.
Voluntary consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) 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 action does not involve
technical standards. Therefore, EPA did not consider the use of any
voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population.

XXVI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report to each House of the Congress and
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 158

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

40 CFR Part 161

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 19, 2013.
Bob Perciasepe,
Acting Administrator.

    Therefore, under the authority of 7 U.S.C. 136-136y and 21 U.S.C.
346a, 40 CFR Chapter I is amended as follows:

PART 158--[AMENDED]

0
1. The authority citation for part 158 continues to read as follows:

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

0
2. Revise Sec.  158.1(c)(4) to read as follows:

Sec.  158.1  Purpose and scope.

* * * * *
    (c) * * *
    (4) Antimicrobial pesticides. Subparts A, B, C, D, and W of this
part apply to antimicrobial pesticides.

0
3. In Sec.  158.100 revise the heading of paragraph (a); revise
paragraph (b); redesignate paragraph (c) as paragraph (e); revise newly
redesignated paragraph (e) and add new paragraphs (c) and (d), to read
as follows:

Sec.  158.100  Pesticide use patterns.

    (a) General use patterns for conventional, biochemical, and
microbial pesticides. * * *
    (b) Pesticide use site index for conventional, biochemical, and
microbial pesticides. The Pesticide Use Site Index for Conventional,
Biochemical, and Microbial Pesticides is a comprehensive list of
specific pesticide use sites. The index is alphabetized separately by
site for all agricultural and all nonagricultural uses. The Pesticide
Use Site Index associates each pesticide use site with one or more of
the 12 general use patterns. It may be used in conjunction with the
data tables to determine the applicability of data requirements to
specific uses. The Pesticide Use Site Index for Conventional,
Biochemical, and Microbial Pesticides will be updated periodically, and
is available from the Agency or may be obtained from the Agency's Web
site at http://www.epa.gov/pesticides.
    (c) Antimicrobial pesticide use patterns. The general use patterns
for antimicrobial pesticides are described in Sec.  158.2201.
    (d) Pesticide use site index for antimicrobial pesticides. The
Pesticide Use Site Index for Antimicrobial Pesticides is a
comprehensive list of specific antimicrobial use sites. The index is
alphabetized by antimicrobial use sites, and associates each
antimicrobial use site with one or more of the antimicrobial use
patterns. It may be used in conjunction with the data tables to
determine the applicability of data requirements to specific uses. The
Pesticide Use Site Index for Antimicrobial Pesticides will be updated
periodically, and is available from the Agency or may be obtained from
the Agency's Web site at http://www.epa.gov/pesticides.
    (e) Determination of use pattern. Applicants unsure of the correct
use pattern for their particular product should consult the Agency.

Sec.  158.400  [Amended]

0
4. In the table in Sec.  158.400(d) remove the heading ``Efficacy of
Antimicrobial Agents,'' and the entries 91-2 through 91-8 under that
category.
0
5. Add subpart W to read as follows:
Subpart W--Antimicrobial Pesticide Data Requirements
Sec.
158.2200 Applicability.
158.2201 Antimicrobial use patterns.
158.2203 Definitions.
158.2204 Public health and nonpublic health claims.
158.2210 Product chemistry.
158.2220 Product performance.
158.2230 Toxicology.
158.2240 Nontarget organisms.
158.2250 Nontarget plant protection.
158.2260 Applicator exposure.
158.2270 Post-application exposure.
158.2280 Environmental fate.
158.2290 Residue chemistry.

Subpart W--Antimicrobial Pesticide Data Requirements

Sec.  158.2200  Applicability.

    Part 158, subpart W establishes data requirements for any pesticide
product that is:
    (a) A pesticide that is intended for use as an ``antimicrobial
pesticide'' within the meaning of FIFRA sec. 2(mm)(1)(A), regardless of
whether it also meets the criterion of FIFRA sec. 2(mm)(1)(B).

That criterion excludes from the definition any antimicrobial product
that is intended for a food-use requiring a tolerance or exemption
under FFDCA sec. 408 or a food additive regulation or clearance under
FFDCA sec. 409. EPA will apply this subpart to all products intended
for an antimicrobial use, purpose or function; the exclusion in FIFRA
sec. 2(mm)(1)(B) does not exclude products from the data requirements
of this subpart.
    (b) A product that bears both antimicrobial and non-antimicrobial
uses or claims. Such a product is subject to the data requirements for
pesticides in subparts C through O, and U or V of this part with
respect to its non-antimicrobial uses and claims, and to the
requirements of this subpart with respect to its antimicrobial uses and
claims.
    (c) A wood preservative, including a product that is intended to
prevent wood degradation problems due to fungal rot or decay, sapstain,
or molds.
    (d) An antifoulant, including a product that is intended to kill or
repel organisms that can attach to underwater surfaces, such as boat
bottoms.

Sec.  158.2201  Antimicrobial use patterns.

    (a) Antimicrobial use patterns. The 12 general use patterns used in
the data tables in this subpart are:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises and equipment.
    (3) Commercial, institutional and industrial premises and
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Industrial processes and water systems.
    (9) Antifoulant paints and coatings.
    (10) Wood preservatives.
    (11) Swimming pools.
    (12) Aquatic areas.
    (b) Use site index. The Pesticide Use Site Index for Antimicrobial
Pesticides is a comprehensive list of specific antimicrobial use sites.
The Index associates antimicrobial use sites with one or more of the 12
antimicrobial use patterns. It is to be used in conjunction with the
data tables in this subpart to determine the applicability of data
requirements to specific uses. The Antimicrobial Pesticide Use Site
Index, which will be updated periodically, is available from the Agency
or may be obtained from the Agency's Web site at http://www.epa.gov/pesticides.

Sec.  158.2203  Definitions.

    The following terms are defined for the purposes of this subpart:
    Disinfectant means a substance, or mixture of substances, that
destroys or irreversibly inactivates bacteria, fungi and viruses, but
not necessarily bacterial spores, in the inanimate environment.
    Fungicide means a substance, or mixture of substances, that
destroys fungi (including yeasts) and fungal spores pathogenic to man
or other animals in the inanimate environment.
    Microbiological water purifier means any unit, water treatment
product or system that removes, kills or inactivates all types of
disease-causing microorganisms from the water, including bacteria,
viruses and protozoan cysts, so as to render the treated water safe for
drinking.
    Sanitizer means a substance, or mixture of substances, that reduces
the bacteria population in the inanimate environment by significant
numbers, but does not destroy or eliminate all bacteria. Sanitizers
meeting Public Health Ordinances are generally used on food contact
surfaces and are termed sanitizing rinses.
    Sterilant means a substance, or mixture of substances, that
destroys or eliminates all forms of microbial life in the inanimate
environment, including all forms of vegetative bacteria, bacterial
spores, fungi, fungal spores, and viruses.
    Tuberculocide means a substance, or mixture of substances, that
destroys or irreversibly inactivates tubercle bacilli in the inanimate
environment.
    Virucide means a substance, or mixture of substances, that destroys
or irreversibly inactivates viruses in the inanimate environment.

Sec.  158.2204  Public health and nonpublic health claims.

    (a) Public health claim. An antimicrobial pesticide is considered
to make a public health claim if the pesticide product bears a claim to
control pest microorganisms that pose a threat to human health, and
whose presence cannot readily be observed by the user, including but
not limited to, microorganisms infectious to man in any area of the
inanimate environment. A product makes a public health claim if one or
more of the following apply:
    (1) A claim is made for control of specific microorganisms that are
directly or indirectly infectious or pathogenic to man (or both man and
animals). Examples of specific microorganisms include, but are not
limited to: Mycobacterium tuberculosis, Pseudomonas aeruginosa,
Escherichia coli (E. coli), human immunodeficiency virus (HIV),
Streptococcus, and Staphylococcus aureus. Claims for control of
microorganisms infectious or pathogenic only to animals (such as canine
distemper virus or hog cholera virus) are not considered public health
claims.
    (2) A claim is made for the pesticide product as a sterilant,
disinfectant, virucide, sanitizer, or tuberculocide against
microorganisms that are infectious or pathogenic to man.
    (3) A claim is made for the pesticide product as a fungicide
against fungi infectious or pathogenic to man, or the product does not
clearly state that it is intended for use only against nonpublic health
fungi.
    (4) A claim is made for the pesticide product as a microbiological
water purifier or microbial purification system.
    (5) A non-specific claim is made that the pesticide product will
beneficially impact or affect public health at the site of use or in
the environment in which it is applied, and:
    (i) The pesticide product contains one or more ingredients that,
under the criteria in 40 CFR 153.125(a), is an active ingredient with
respect to a public health microorganism and there is no other
functional purpose for the ingredient in the product; or
    (ii) The pesticide product is similar in composition to a
registered pesticide product that makes antimicrobial public health
claims.
    (b) Nonpublic health claim. An antimicrobial pesticide is
considered to make a nonpublic health claim if the pesticide product
bears a claim to control microorganisms of economic or aesthetic
significance, where the presence of the microorganism would not
normally lead to infection or disease in humans. Examples of nonpublic
health claims include, but are not limited to: Algaecides, slimicides,
preservatives and products for which a pesticidal claim with respect to
odor sources is made.

Sec.  158.2210  Product chemistry.

    The product chemistry data requirements of subpart D of this part
apply to antimicrobial products covered by this subpart.

Sec.  158.2220  Product performance.

    (a) General--(1) Product performance requirement for all
antimicrobial pesticides. Each applicant must ensure through testing
that his product is efficacious when used in accordance with label
directions and commonly accepted pest control practices. The Agency may
require, on a case-by-case basis, submission of product

performance data for any pesticide product registered or proposed for
registration or amendment.
    (2) Product performance data for each product that bears a public
health claim. Each product that bears a public health claim, as
described in Sec.  158.2204(a), must be supported by product
performance data, as listed in the table in paragraph (c) of this
section. Product performance data must be submitted with any
application for registration or amended registration.
    (3) Product performance data for each product that bears a
nonpublic health claim. Each product that bears a nonpublic health
claim, as described in Sec.  158.2204(b), must be supported by product
performance data. Each registrant must ensure through testing that his
product is efficacious when used in accordance with label directions
and commonly accepted practices. The Agency reserves the right to
require, on a case-by-case basis, submission of product performance
data for any pesticide product registered or proposed for registration
or amendment.
    (4) Determination of data requirements. Subpart B of this part and
Sec.  158.2201 describe how to use the table in paragraph (c) of this
section to determine the product performance data requirements for
antimicrobial pesticide products.
    (b) Key. R = Required; EP = End-use product.
    (c) Antimicrobial product performance data requirements table. The
following table shows the data requirements for antimicrobial product
performance.

                           Table--Antimicrobial Product Performance Data Requirements
----------------------------------------------------------------------------------------------------------------
         Guideline No.               Data requirement          All use patterns             Test substance
----------------------------------------------------------------------------------------------------------------
810.2100.......................  Sterilants--Efficacy     R.........................  EP
                                  Data Recommendations.
810.2200.......................  Disinfectants for Use    R.........................  EP
                                  on Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2300.......................  Sanitizers for Use on    R.........................  EP
                                  Hard Surfaces--
                                  Efficacy Data
                                  Recommendations.
810.2400.......................  Disinfectants and        R.........................  EP
                                  Sanitizers for Use on
                                  Fabrics and Textiles--
                                  Efficacy Data
                                  Recommendations.
810.2500.......................  Air Sanitizers--         R.........................  EP
                                  Efficacy Data
                                  Recommendations.
810.2600.......................  Disinfectants for Use    R.........................  EP
                                  in Water--Efficacy
                                  Data Recommendations.
----------------------------------------------------------------------------------------------------------------

Sec.  158.2230  Toxicology.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (g) of this section to determine the
toxicology data requirements for an antimicrobial pesticide product.
Notes that apply to an individual test, including specific conditions,
qualifications, or exceptions are listed in paragraph (h) of this
section.
    (b) Uses. The applicant for registration must first determine
whether the use is likely to result in pesticide residues in food or
water and therefore consult the ``Food Use'' columns of the table in
paragraph (g) of this section. Generally, if the residues of the
antimicrobial result from an application to a surface or if
incorporated into a material that may come into contact with food or
feed, and residues may be expected to transfer to such food or feed,
then the ``Indirect Food Uses'' columns is to be consulted.
    (c) Tiering of data requirements. Applicants for registration of
antimicrobials may perform tests in a tiered fashion. After the
initially required tests are conducted, additional testing may be
required if results of the initial tests trigger the need for
additional data. Conditions that trigger the need for additional data
are given in the test notes in paragraph (h) of this section.
    (d) 200 parts per billion (ppb). The 200 ppb level was originally
used by the Food and Drug Administration with respect to the
concentration of residues in or on food for tiering of data
requirements for indirect food use biocides. The Agency has also
adopted this same residue level for determining toxicology data
requirements for indirect food uses of antimicrobial pesticides. The
200 ppb level is the concentration of antimicrobial residues in or on
the food item.
    (e) Use of OSHA standards. If EPA determines that industrial
standards, such as the workplace standards set by the Occupational
Safety and Health Administration (OSHA standards), provide adequate
protection for a particular pesticide or a particular use pattern,
additional toxicity data may not be required for that pesticide or the
use pattern.
    (f) Key. R = Required; CR = Conditionally required; NR = Not
required; MP = Manufacturing-use product; EP = End-use product; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product; PAI = Pure active ingredient; PAIRA = Pure active ingredient,
radiolabeled; Choice = choice of several test substances depending on
studies required.
    (g) Antimicrobial toxicology data requirements table. The following
table shows the data requirements for toxicology. The test notes
applicable to the data requirements in this table appear in paragraph
(h) of this section.

                                                                        Table--Antimicrobial Toxicology Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Food uses                                          Nonfood uses                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Swimming pools,
  Guideline No.     Data  requirement                                                                 aquatic areas, wood                                                          Test note No.
                                         Direct food uses    Indirect food uses   Indirect food uses     preservatives,     All other nonfood          MP               EP
                                                                 (>200 ppb)          (<=200 ppb)         metal working             uses
                                                                                fluids
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Acute Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100.........  Acute oral          R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            1, 2
                    toxicity--rat.

870.1200.........  Acute dermal        R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    toxicity.
870.1300.........  Acute inhalation    R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....            2, 4
                    toxicity--rat.
870.2400.........  Primary eye         R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation--rabbi
                    t.
870.2500.........  Primary dermal      R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....         1, 2, 3
                    irritation.
870.2600.........  Dermal              R..................  R..................  R..................  R..................  R..................  MP and TGAI....  EP and TGAI....      1, 2, 3, 5
                    sensitization.
870.2600.........  Acute               R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........           6, 11
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Subchronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100.........  90-Day oral         R..................  R..................  R..................  R..................  CR.................  TGAI...........  TGAI...........    8, 9, 15, 38
                    toxicity--rodent.
870.3150.........  90-Day oral         R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........          10, 15
                    toxicity--nonrode
                    nt.
870.3200.........  21/28-Day dermal    CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....          12, 13
                    toxicity.
870.3250.........  90-Day dermal       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  EP and TGAI....   7, 13, 14, 15
                    toxicity.
870.3465.........  90-Day inhalation   CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........   7, 15, 16, 17
                    toxicity--rat.
870.6200.........  90-Day              R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........            6, 8
                    neurotoxicity--ra
                    t.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Chronic Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100.........  Chronic oral        R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      18, 19, 20
                    toxicity--rodent.
870.4200.........  Carcinogenicity--t  R..................  R..................  CR.................  R..................  CR.................  TGAI...........  TGAI...........      19, 21, 22
                    wo rodent
                    species--rat and
                    mouse preferred.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Developmental Toxicity and Reproduction
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700.........  Prenatal            R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  23, 24, 25, 26
                    developmental
                    toxicity--rat and
                    rabbit preferred.
870.3800.........  Reproduction and    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........  26, 27, 28, 29
                    fertility effects.
870.6300.........  Developmental       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      28, 29, 30
                    neurotoxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Mutagenicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100.........  Reverse mutation    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 32
                    assay.
870.5300.........  In vitro mammalian  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 33
870.5375.........   gene mutation.
870.5385.........  In vivo             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........          31, 34
870.5395.........   cytogenetics.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Special Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
870.7485.........  Metabolism and      R..................  R..................  CR.................  R..................  CR.................  PAI or PAIRA...  PAI or PAIRA...          35, 39
                    pharmacokinetics.
870.7200.........  Companion animal    CR.................  CR.................  CR.................  CR.................  CR.................  NR.............  Choice.........              36
                    safety.
870.7600.........  Dermal penetration  CR.................  CR.................  CR.................  CR.................  CR.................  Choice.........  Choice.........           3, 37

870.7800.........  Immunotoxicity....  R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               8
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (h) Test notes. The following test notes apply to the data
requirements in the table to paragraph (g) of this section:
    1. Not required if test material is a gas or highly volatile
liquid.
    2. The six end-use product (EP) acute toxicity studies are required
using the product as formulated for sale and distribution. In addition,
if the EP label has directions for diluting the product, then, the
applicant may also need to conduct certain of the acute toxicity
studies using the highest concentration labeled for dilution (i.e., the
least diluted product). The end-use dilution testing is in addition to
the testing conducted on the EP.
    3. Not required if test material is corrosive to skin or has pH
less than 2 or greater than 11.5.
    4. Data are required when the product consists of, or under
conditions of use will result in, a respirable material (e.g., gas,
vapor, aerosol or particulates).
    5. Data are required if repeated dermal exposure is likely to occur
under conditions of use.
    6. For indirect food uses <= 200 ppb, and all other nonfood uses,
data are required if the neurotoxicity screen in the 90-day oral rodent
study or other data indicate neurotoxicity.
    7. The 90-day dermal toxicity study and/or 90-day inhalation
toxicity study are required if the Agency determines that dermal and/or
inhalation exposure is the primary route of exposure.
    8. All 90-day subchronic studies in the rodent can be designed to
simultaneously fulfill the requirements of the 90-day neurotoxicity
and/or immunotoxicity studies by adding separate groups of animals for
testing of neurotoxicity and/or immunotoxicity parameters.
    9. The 90-day study is required in the rodent for hazard
characterization (possibly endpoint selection) and dose-setting for the
chronic/carcinogenicity study. It is not required in the mouse, but the
Agency would encourage the applicant to conduct a 90-day range finding
study for the purposes of dose selection for the mouse carcinogenicity
study to achieve adequate dosing and an acceptable study.
    10. A 1-year non-rodent study (i.e., 1-year dog study) may be
required if the Agency finds that a pesticide chemical is highly
bioaccumulative and slowly eliminated. EPA may also require the
appropriate metabolism and pharmacokinetic studies to evaluate more
precisely bioavailability, half life, and steady state to determine if
a longer duration dog toxicity study is needed.
    11. Although the subchronic toxicity testing guidelines include
measurement of neurological endpoints, such screens do not meet the
requirement of the 90-day neurotoxicity study. For nonfood uses, if the
90-day study does not include a neurotoxicity screen, then the acute
neurotoxicity study will be required.
    12. Data are required if all of the following criteria are met:
    i. The intended use of the antimicrobial pesticide product is
expected to result in repeated dermal human exposure to the product.
    ii. Data from a 90-day dermal toxicity study are not available.
    iii. The 90-day dermal toxicity study has not been triggered.
    13. EP testing is required if the product or any component of the
product may increase dermal absorption of the active ingredient(s) or
increases its toxic or pharmacologic effects, as determined by testing
using the TGAI or based on available information about the toxic
effects of the product or its components.
    14. Data are required if the active ingredient in the product is
known or expected to be metabolized differently by the dermal route of
exposure than by the oral route, and a metabolite of the active
ingredient is the toxic moiety.
    15. A 90-day oral toxicity test is not required for heating,
ventilation, air conditioning, and refrigeration systems (collectively
referred to as HVAC&R). Instead, two 90-day toxicity tests, one by the
dermal route and one by the inhalation route are required.
    16. Data are required if there is the likelihood of significant
repeated inhalation exposure to the pesticide as a gas, vapor, or
aerosol.
    17. Based on estimates of the magnitude and duration of human
exposure, studies of shorter duration, e.g., 21- or 28-days, may be
sufficient to satisfy this requirement. The prime consideration in
determining the appropriateness of a shorter duration study is the
likely period of time for which humans will be exposed.
    18. Based on the positive results of the acute or 90-day
neurotoxicity studies, or on other data indicating neurotoxicity, a
chronic neurotoxicity study (i.e., a chronic study with additional
neurotoxicity evaluations) may be required to provide information about
potential neurotoxic effects from long-term exposures.
    19. Studies which are designed to simultaneously fulfill the
requirements of both the chronic oral and carcinogenicity studies
(i.e., a combined study) may be conducted.
    20. For indirect food uses <= 200 ppb, and all other nonfood uses,
data are required if either of the following criteria are met:
    i. The use of the pesticide is likely to result in repeated human
exposure over a considerable portion of the human lifespan; or
    ii. The use requires that a tolerance, tolerance exemption, or food
additive regulation or clearance be established.
    21. For indirect food uses <= 200 ppb, and all other nonfood uses,
data are required if any of the following criteria, are met:
    i. The use of the pesticide is likely to result in significant
human exposure over a considerable portion of the human life span which
is significant in terms of frequency, time, duration, and/or magnitude
of exposure.
    ii. The use requires that a tolerance, tolerance exemption, or food
additive regulation or clearance be established.
    iii. The active ingredient, metabolite, degradate, or impurity:
    A. Is structurally related to a recognized carcinogen;
    B. Causes mutagenic effects as demonstrated by in vitro or in vivo
testing; or
    C. Produces a morphologic effect in any organ (e.g., hyperplasia,
metaplasia) in subchronic studies that may lead to a neoplastic change.
    22. If the requirement for a carcinogenicity study in any species
is modified or waived for any reason, then

a subchronic 90-day oral study in the same species may be required.
    23. Testing in two species is required for all uses.
    24. The oral route, by oral intubation, is preferred, unless the
chemical or physical properties of the test substance, or the pattern
of human exposure, suggest a more appropriate route of exposure.
    25. Additional testing by other routes of exposure may be required
if the pesticide is determined to be a prenatal developmental toxicant
after oral dosing.
    26. The developmental toxicity study in rodents may be combined
with the two-generation reproduction study in rodents by using a second
mating of the parental animals in either generation. Protocols must be
approved by the Agency prior to the initiation of the study.
    27. A two-generation reproduction study is required.
    28. An information-based approach to testing is preferred, which
utilizes the best available knowledge on the chemical (hazard,
pharmacokinetic, or mechanistic data) to determine whether a standard
guideline study, an enhanced guideline study, or an alternative study
should be conducted to assess potential hazard to the developing
animal. Applicants must submit any alternative proposed testing
protocols and supporting scientific rationale to the Agency. Protocols
must be approved by the Agency prior to the initiation of the study.
    29. The use of a combined two-generation reproduction/developmental
neurotoxicity study that utilizes the two-generation reproduction study
in rodents as a basic protocol for the addition of other endpoints or
functional assessments in the immature animal is encouraged.
    30. A DNT study is required using a weight-of-evidence approach
when:
    i. The pesticide causes treatment-related neurological effects in
adult animal studies (i.e., clinical signs of neurotoxicity,
neuropathology, functional or behavioral effects).
    ii. The pesticide causes treatment-related neurological effects in
developing animals, following pre- or post-natal exposure (i.e.,
nervous system malformations or neuropathy, brain weight changes in
offspring, functional or behavioral changes in the offspring).
    iii. The pesticide elicits a causative association between
exposures and adverse neurological effects in human epidemiological
studies.
    iv. The pesticide evokes a mechanism that is associated with
adverse effects on the development of the nervous system (i.e.,
structure-activity-relationship (SAR) to known neurotoxicants, altered
neuroreceptor or neurotransmitter responses).
    31. To facilitate the weight-of-evidence determination for the
pesticide's mutagenicity, in addition to those specifically listed in
this table, the Agency requires submission of other mutagenicity test
results that may have been performed. A reference list of all studies
and papers known to the applicant concerning the mutagenicity of the
test chemical must be submitted with the required studies.
    32. Due to the nature of antimicrobials, if testing with bacterial
strains has not been conducted, then testing using a mammalian cell
assay such as the mouse lymphoma TK +/- assay is preferred. If reverse
mutation assay testing with bacterial strains has already been
conducted, and the testing was conducted at levels that did not cause
toxicity to the bacterial strains tested, then the applicant may submit
the study to fulfill this data requirement.
    33. For the in vitro mammalian gene mutation study, there is a
choice of assays using either mouse lymphoma L5178Y cell thymidine
kinase (tk) gene locus, maximizing assay conditions for small colony
expression and detection; Chinese hamster ovary (CHO) or Chinese
hamster lung fibroblast (v79) cells, hypoxanthine-guanine
phosphoribosyl transferase (hgprt) gene locus, accompanied by an
appropriate in vitro test for clastogenicity; or CHO cells strains
AS52, xanthine-guanine phosphoribosyl transferase (xprt) gene locus.
    34. There is a choice of assays, but the micronucleus rodent bone
marrow assay is preferred; the rodent bone marrow assays using
metaphase analysis (aberrations) are acceptable.
    35. Data are required when chronic toxicity or carcinogenicity
studies are also required.
    36. Data is required if the product label directs that it be
applied to domestic animals, such as cats, dogs, cattle, pigs, and
horses.
    37. In the absence of dermal absorption data or a repeated dose
dermal toxicity study, the assumption of 100 percent dermal absorption
would be used in a risk assessment to determine if a dermal penetration
study is required, and to identify the doses and duration of exposure
for which dermal absorption is to be quantified.
    38. Required for nonfood uses, if oral exposure could occur.
    39. Data may be required if significant adverse effects are seen in
available toxicology studies and these effects can be further
elucidated by metabolism and pharmacokinetics studies.

Sec.  158.2240  Nontarget organisms.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (c) of this section to determine the
terrestrial and aquatic nontarget organisms data requirements for a
particular antimicrobial pesticide product. Notes that apply to an
individual test, including specific conditions, qualifications, or
exceptions are listed in paragraph (d) of this section.
    (1) Terrestrial and aquatic nontarget organism data are required to
support the registration of most end-use and manufacturing-use
antimicrobial products.
    (2) Data are generally not required to support end-use products of
a gas, highly volatile liquid, highly reactive solid, or a highly
corrosive material.
    (3) Data on transformation/degradation products or leachate
residues of the parent compound are also required to support
registration, if the transformation/degradation/degradation products or
leachate residues meet one of the following criteria:
    (i) More toxic, persistent, or bioaccumulative than the parent;
    (ii) Have been shown to cause adverse effects in mammalian or
aquatic reproductive studies; or
    (iii) The moiety of concern (i.e., functional group in the parent
chemical molecule that imparts adverse effects) remains intact.
    (4) If an antimicrobial may be applied to a field crop,
horticultural crop, or turf, then the data requirements in Sec.
158.630 apply.
    (5) For the purpose of determining data requirements, the all other
use patterns category includes the following use patterns:
    (i) Agricultural premises and equipment.
    (ii) Food-handling/storage establishments, premises, and equipment.
    (iii) Commercial, institutional and industrial premises and
equipment.
    (iv) Residential and public access premises.
    (v) Medical premises and equipment.
    (vi) Human drinking water systems.
    (vii) Materials preservatives.
    (viii) Swimming pools.
    (b) Key. MP = Manufacturing use product; EP = End-use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product; PAIRA = Pure active ingredient radiolabeled; a.i. = active
ingredient.

    (c) Antimicrobial nontarget organism data requirements table. The
following table shows the data requirements for nontarget organisms.
The test notes appear in paragraph (d) of this section.

                                                                    Table--Antimicrobial Nontarget Organism Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use pattern                                                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement       Industrial                                                                                Test note No.
                                       processes and water      Antifoulant      Wood  preservatives     Aquatic areas        All other use            MP               EP
                                             systems        coatings and paints                                             patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Tier One Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100.........  Acute avian oral    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               1
                    toxicity.
850.1010.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               2
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........               3
                    fish toxicity.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Higher Tier Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian Testing...................................................................................................................................................................................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200.........  Avian dietary       CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........               4
                    toxicity.
850.2300.........  Avian reproduction  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            1, 6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Aquatic Organisms Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         2, 5, 7
                    invertebrates
                    toxicity.
850.1075.........  Acute freshwater    CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         3, 5, 7
                    fish toxicity.
850.1025.........  Acute estuarine     CR.................  R..................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........            8, 9
                    and marine
                    organisms
                    toxicity.
850.1035
850.1045
850.1055.........  Acute estuarine     CR.................  CR.................  CR.................  CR.................  CR.................  ...............  TEP............         5, 7, 8
                    and marine
                    organisms
                    toxicity.
850.1075
850.1400.........  Fish early-life     R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    stage.
850.1300.........  Aquatic             R..................  R..................  R..................  R..................  R..................  TGAI...........  TGAI...........              10
                    invertebrate life-
                    cycle.
850.1350
850.1500.........  Fish life-cycle...  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          11, 12
850.1710.........  Aquatic organisms,  CR.................  CR.................  CR.................  CR.................  CR.................  TGAI, PAI,       TGAI, PAI,                   13
                    bioavailability,                                                                                degradate.       degradate.
                    biomagnification,
                    toxicity tests.
850.1730
850.1850
850.1950.........  Simulated or        CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............      14, 15, 16
                    actual field
                    testing for
                    aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Sediment Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1735.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........          15, 17
                    acute freshwater
                    invertebrates.
850.1740.........  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 17, 19
                    acute marine
                    invertebrates.
None.............  Whole sediment;     CR.................  CR.................  CR.................  CR.................  CR.................  TGAI...........  TGAI...........      15, 18, 19
                    chronic
                    invertebrates
                    fresh-water and
                    marine.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                Insect Pollinator Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3020.........  Honeybee acute      NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TGAI...........              20
                    contact.
850.3030.........  Toxicity of         NR.................  NR.................  R..................  NR.................  CR.................  TGAI...........  TEP or treated           20, 21
                    residues to                                                                                wood.
                    honeybees.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     (d) Test notes. The following test notes apply to the data
requirements in the table to paragraph (c) of this section:
    1. For industrial processes and water systems, antifoulant paints
and coatings, wood preservatives, and aquatic areas, data are required
for two avian species: one waterfowl species and one upland game bird
species. For the all other use patterns category (as specified in Sec.
158.2240(a)(5)), data are required for one avian species.
    2. Data are required on one freshwater aquatic invertebrate
species.
    3. For the industrial processes and water systems, antifoulant
paints and coatings, wood preservatives, and aquatic use pattern areas,
data are required on two species of fish, one cold water species and
one warm water species. For the all other use patterns category (as
specified in Sec.  158.2240(a)(5)), data are required on one species of
fish, either one cold water species or one warm water species. Testing
on a second species is required if the active ingredient or principal
transformation products are stable in the environment and the
LC50 in the first species is less than or equal to 1 ppm or
1 mg/L.
    4. Data are required on one avian species, either one waterfowl
species or one upland game bird species, if the avian acute oral
LD50 (TGAI testing) is less than or equal to 100 mg/a.i./kg
and a.i. residues or its principal transformation products are likely
to occur in avian feed items. Data on the second species are required
if the avian dietary LC50 in the first species tested is
less than or equal to 500 ppm a.i. in the diet.
    5. If TEP testing cannot be conducted due to the physical
characteristics of the test substance (for example, a paint), then the
applicant should request a waiver.
    6. Data are required if one or more of the following criteria are
met:
    i. Birds may be subjected to repeated or continued exposure to the
pesticide or any of its transformation products, especially preceding
or during the breeding season.
    ii. The pesticide or any of its major metabolites or degradation
products are stable in the environment to the extent that a potentially
toxic amount may persist in avian feed.
    iii. The pesticide or any of its major metabolites or degradation
products are stored or accumulated in plant or animal tissues, as
indicated by the octanol/water partition coefficient (Kow is
greater than or equal to 1,000), accumulation studies, metabolic
release and retention studies, or as indicated by structural similarity
to known bioaccumulative chemicals.
    iv. Any other information, such as that derived from mammalian
reproduction studies, indicates that reproduction in terrestrial
vertebrates may be adversely affected by the anticipated use of the
pesticide product.
    7. TEP testing is required for any product which meets one or more
of the following conditions:
    i. When based on deterministic modeling results: If the Estimated
Environmental Concentration (EEC) in the aquatic environment is equal
to or greater than one-half the LC50/EC50 of the
TGAI.
    ii. When based on probabilistic modeling results: If the estimated
10th percentile 7Q10 Surface Water Concentration exceeds the acute
concentration of concern (i.e., one-half the LC50/
EC50).
    iii. If an ingredient in the end-use product other than the active
ingredient is expected to enhance the toxicity of the active ingredient
or to cause toxicity to aquatic organisms.
    iv. The end-use antimicrobial product will be applied directly into
an aquatic environment.
    8. Data are required on one estuarine/marine mollusk, one other
estuarine/marine invertebrate, and one estuarine/marine fish species.
    9. For the all other use patterns category (as specified in Sec.
158.2240(a)(5)), industrial processes and water systems, wood
preservatives, and aquatic areas, data are required if the pesticide
residues from the parent compound and/or transformation products are
likely to enter the estuarine/marine environment.
    10. Testing must be conducted with the most sensitive organism
(either freshwater or estuarine/marine vertebrates, or freshwater or
estuarine/marine invertebrates), as determined from the results of the
acute toxicity tests (acute EC50 freshwater invertebrates;
acute LC50/EC50 estuarine and marine organisms;
acute freshwater fish LC50).
    11. Data are required on estuarine/marine species if the product is
intended for direct application to the estuarine or marine environment,
or the product is expected to enter this environment in significant
concentrations because of its expected use or mobility patterns.
    12. Data are required on freshwater species if the end-use product
is intended to be applied directly to water, or is expected to be
transported to water from the intended use site, and when one or more
of the following conditions apply:
    i. When based on deterministic modeling results: If the Estimated
Environmental Concentration (EEC) in water is equal to or greater than
0.1 of the no-observed-adverse-effect concentration or no-observed-
adverse-effect level (NOAEC/NOAEL) in the fish early-life stage or
invertebrate life cycle tests.
    ii. When based on probabilistic modeling results: If the estimated
10th percentile 7Q10 Surface Water Concentration based on probabilistic
modeling exceeds for 20 days or more the chronic concentration of
concern (i.e., one-tenth the NOAEC or NOAEL) determined in the fish
early-life stage or invertebrate life cycle tests.
    iii. If studies of other organisms indicate that the reproductive
physiology of fish may be affected.
    13. Not required when:
    i. The octanol/water partition coefficients of the pesticide and
its major degradates are less than 1,000;
    ii. There are no potential exposures to fish and other nontarget
aquatic organisms; or

    iii. The hydrolytic half-life is less than 5 days at pH 5, 7, and
9.
    14. Environmental chemistry methods used to generate data
associated with this study must include results of a successful
confirmatory method trial by an independent laboratory. Test standards
and procedures for independent laboratory validation are available as
addenda to the guideline for this test requirement.
    15. Protocols must be approved by the Agency prior to the
initiation of the study.
    16. Data are required if the intended use pattern, and the
physical/chemical properties and environmental fate characteristics of
the antimicrobial indicate significant potential exposure, and, based
on the results of the acute and chronic aquatic organism testing,
significant impairment of nontarget aquatic organisms could result.
    17. Data are required if the half-life of the pesticide in the
sediment is equal to or less than 10 days in either the aerobic soil or
aquatic metabolism studies, and if one or more of the following
conditions are met:
    i. The soil partition coefficient (Kd) is equal to or
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    18. Data are required if the EEC in sediment is greater than 0.1 of
the acute LC50/EC50 values and if one or more of
the following conditions are met:
    i. The soil partition coefficient (Kd) is equal to or
greater than 50 L/kg.
    ii. The log Kow is equal to or greater than 3.
    iii. The Koc is equal to or greater than 1,000.
    19. Sediment testing with estuarine/marine test species is required
if the product is intended for direct application to the estuarine or
marine environment or the product is expected to enter this environment
in significant concentrations either by runoff or erosion, because of
its expected use or mobility pattern.
    20. For the all other use patterns category (as specified in Sec.
158.2240(a)(5)), data are required only for beehive applications when
the beehive (empty or occupied) may be treated.
    21. A study similar to ``Honey Bee Toxicity of Residues on
Foliage'' is required using treated wood instead of the foliage.
Protocols must be approved by the Agency prior to the initiation of the
study.

Sec.  158.2250  Nontarget plant protection.

    (a) Subpart B of this part and Sec.  158.2201 describe how to use
the table in paragraph (f) of this section to determine the nontarget
plant protection data requirements for a particular antimicrobial
pesticide product. Notes that apply to an individual test including
specific conditions, qualifications, or exceptions are listed in
paragraph (g) of this section.
    (b) Data on transformation/degradation products or leachate
residues of the parent compound are also required to support
registration, if the transformation/degradation products or leachate
residues meet one of the following criteria:
    (1) More toxic, persistent, or bioaccumulative than the parent;
    (2) Have been shown to cause adverse effects in mammalian or
aquatic reproductive studies; or
    (3) The moiety of concern (i.e., functional group in the parent
chemical molecule that imparts adverse effects) remains intact.
    (c) For the purpose of determining data requirements, the all other
use patterns category includes the following use patterns:
    (1) Agricultural premises and equipment.
    (2) Food-handling/storage establishments, premises, and equipment.
    (3) Commercial, institutional and industrial premises and
equipment.
    (4) Residential and public access premises.
    (5) Medical premises and equipment.
    (6) Human drinking water systems.
    (7) Materials preservatives.
    (8) Swimming pools.
    (d) If an antimicrobial may be applied to a field crop,
horticultural crop, or turf, then the data requirements in Sec.
158.660 apply.
    (e) Key. MP = Manufacturing use product; EP = End-use product; R =
Required; CR = Conditionally required; NR = Not required; TGAI =
Technical grade of the active ingredient; TEP = Typical end-use
product.
    (f) Nontarget plant protection data requirements table. The
following table shows the data requirements for nontarget plant
protection. The test notes appear in paragraph (g) of this section.

                                                                       Table--Nontarget Plant Protection Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use pattern                                                         Test substance
                                      -------------------------------------------------------------------------------------------------------------------------------------------
  Guideline No.     Data  requirement       Industrial                                                                                Test note No.
                                       processes and water      Antifoulant       Wood preservatives     Aquatic areas        All other use            MP               EP
                                             systems        coatings and paints                                             patterns  category
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225.........  Seedling            CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 2
                    emergence, Tier
                    II--dose response.
850.4250.........  Vegetative vigor,   CR.................  NR.................  CR.................  CR.................  CR.................  TEP............  TEP............            1, 3
                    Tier II--dose
                    response.
850.4400.........  Aquatic plant       R..................  R..................  R..................  R..................  CR.................  TGAI, TEP......  TGAI, TEP......           4, 10
                    growth (aquatic
                    vascular plant)
                    Tier II--dose
                    response.
850.5400.........  Aquatic plant       R..................  R..................  R..................  R..................  R..................  TGAI, TEP......  TGAI, TEP......         4, 5, 6
                    growth (algal)
                    Tier II (dose
                    response).
850.4300.........  Terrestrial field.  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
850.4450.........  Aquatic field.....  CR.................  CR.................  CR.................  CR.................  CR.................  TEP............  TEP............         7, 8, 9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (g) Test notes. The following test notes apply to the data
requirements in the table to paragraph (f) of this section:
    1. Data on only one plant species (rice, Oryza sativa) are
required.
    2. Data are required if the risk quotient from any aquatic plant
growth Tier II study exceeds a level of concern for aquatic plants.
    3. Not required when:
    i. There are no potential exposures to plants;
    ii. The hydrolytic half-life is less than 5 days at pH 5, 7, and 9;
or
    iii. The results of a biodegradation study indicate that the active
ingredient or principal degradation products are not biodegradable in
28 days, i.e., the biodegradation curve has not reached a plateau for
at least three determinations within the 28 days.
    4. For TEP testing, data are required for the applicant's end-use
product if an ingredient in the end-use product, other than the active
ingredient, is expected to enhance the toxicity of the active
ingredient.
    5. One Tier II (dose response) study, conducted with Selenastrum
capricornutum, is required for the all other use patterns category (as
specified in Sec.  158.2250(c)). If the results of this study exhibit
detrimental effects (EC50 less than 1.0 ppm or mg/L), then
additional Tier II (dose response) studies are required on three
species (Anabaena flos-aquae, Navicula pelliculosa, and Skeletonema
costatum).
    6. For industrial processes and water systems, antifoulant coatings
and paints, wood preservatives, and aquatic areas, Tier II (dose
response) studies are required on four species (Anabaena flos-aquae,
Navicula pelliculosa, Skeletonema costatum, and Selenastrum
capricornutum).
    7. Environmental chemistry methods used to generate data must
include the results of a successful confirmatory method trial by an
independent laboratory.
    8. Tests are required on a case-by-case basis based on the results
of lower tier plant protection studies, adverse incident reports,
intended use pattern, and environmental fate characteristics that
indicate potential exposure.
    9. Protocols must be approved by the Agency prior to the initiation
of the study.
    10. For the all other use patterns category (as specified in Sec.
158.2250(c)), data are required if the aquatic (algal) plant growth
Tier II study demonstrates detrimental effects at less than 1.0 ppm or
mg/L.

Sec.  158.2260  Applicator exposure.

    (a) General. Subpart B of this part and Sec.  158.2201 describe how
to use the table in paragraph (d) of this section to determine the
applicator exposure data requirements for antimicrobial pesticide
products. Notes that apply to an individual test including specific
conditions, qualifications, or exceptions are listed in paragraph (e)
of this section.
    (1) The Agency may accept surrogate exposure data estimations and/
or modeling estimations from other sources to satisfy exposure data
requirements. The surrogate data must meet the basic quality assurance,
quality control, good laboratory practice, and other scientific
requirements set by EPA. To be acceptable, the Agency must find that
the surrogate exposure data estimations have adequate information to
address the applicable exposure data requirements and contain adequate
monitoring events of acceptable quality. The data must reflect the