did not believe it was necessary to require both when a ``true bug''
claim was still in consideration. Based on experience, EPA has since
opted to propose that they be separate pest-specific claims.
    16. Ants (excluding carpenter ants). In the proposed 40 CFR
158.1776, the EPA is proposing data requirements for pest group ``Ants
(excluding carpenter ants),'' for the pest sub-groups ``Fire and
Harvester ants,'' ``Fire and Harvester ant colonies,'' and ``Fire
ants,'' and for seven pest-specific claims in the absences of a pest
group or sub-group claim.
    For colony claims, testing must be done specific to the species
listed. For colony claims against the red and/or black imported fire
ants, testing may be done on the red imported fire ant (RIFA)
(Solenopsis invicta), the black imported fire ant (Solenopsis richteri)
or their hybrid.
    Data for the pharaoh ant (Monomorium pharaonis) and red imported
fire ant (Solenopsis invicta) would be required to support a general
claim against ants, except carpenter ants. EPA proposes RIFA to receive
a claim against fire and harvester ants for direct spray kill and
residual surface application claims against foraging ants only
(excluding colony claims). For bait products or claims involving
outdoor use, testing must be specific to the

species listed. For colony claims, testing must be specific to the
species listed. For colony claims against the red and/or black imported
fire ants, testing may be done on, S. invicta, S. richteri, or their
hybrid.
    Public comments on the 2013 SAP suggested that additional clarity
was needed for categories such as ``ants'' where only certain members
of the group would be considered pests of significant public health
importance. (See, e.g., Ref. 40). Similar to EPA's current practice for
spiders, EPA requires product performance data for certain species-
specific claims (e.g. ``fire ants'') and for general claims against
``ants'' or ``ants, unless certain species are expressly excluded,
i.e., fire, pharaoh, harvester, and carpenter ants.'' Fire and
harvester ants are considered pests of significant public health
importance, due to their painful stings that may result in anaphylaxis,
while pharaoh ants are considered pests of significant public health
importance because they can transfer numerous pathogens much like
cockroaches. As discussed separately in more detail in Unit VII.C.18 of
this proposal, Carpenter ants are structural pests which also require
the submission of efficacy data. As a result, if an applicant submits a
draft label with a claim against ``ants (excluding fire, pharaoh,
harvester, and carpenter ants),'' the applicant does not need to
provide product performance data to EPA. Instead, the applicant would
generate efficacy data to confirm that the product is effective against
these non-public health pests and then hold those data in their files.
However, a label claim against ``ants'' encompasses, pests of
significant public health importance and structural pests, and
therefore for a ``kills ants'' label claim, the applicant would need to
submit at least three product performance studies to EPA to verify this
claim, one study each for the fire ant (which can be bridged to cover
the harvester ant for a direct spray test), pharaoh ant, and carpenter
ant. For a more detailed discussion of the ``Carpenter ants'' claim,
see Unit VII.C.18 of this proposal.
    The SAP also suggested adding the following ants to the ``Ants
(except carpenter ants)'' group: European fire ant, odorous house ant,
red imported fire ant (RIFA), tropical fire ant, thief ant, dark rover
ant, hairy crazy ant, Caribbean crazy ant, yellow crazy ant, pavement
ant, and Crematogaster spp. Fire ants (Solenopsis spp.). Some of the
species suggested for inclusion are not pests of significant public
health importance (odorous house ant, thief ant, dark rover ant, hairy
crazy ant, Caribbean crazy ant, yellow crazy ant, and pavement ant),
and thus EPA is not proposing product performance data requirements
specific to these species.
    17. Bees, Wasps, Yellowjackets, and Hornets. For proposed 40 CFR
158.1780, EPA is proposing data requirement for a pest group claim
``Bees, Wasps, Yellowjackets, and Hornets'' and pest-specific claim for
bald-faced hornet, mud dauber wasp, paper wasp, and yellowjackets. For
the performance standards, EPA is proposing standards consistent with
proposed 40 CFR 158.1704. For colony claims against Vespula spp. EPA is
proposing a performance standard of 100%.
    For the pest group claim, EPA is proposing data on two yellowjacket
species (one Vespula sp. and the bald-faced hornet (Dolichovespula
maculata)) and one paper wasp (Polistes sp.). These required test
species were chosen based on their painful stings that may cause life-
threatening reactions. The SAP was supportive of the selection of these
species as representative to this pest group.
    For the pest-specific claims that were proposed, one commenter
indicated that stinging bees and wasps, solitary and ground nesting
Hymenoptera such as mud daubers, digger wasps/bees, and spider wasps
should not be included as pests of significant public health
importance. The commenter believed that these females use their
stingers for hunting, not defense, which means that it is unlikely such
a pest would pose a public health threat. (Ref. 40). Another commenter
added that they are also beneficial insects. (Ref. 41). However, these
insects can inflict painful stings that may cause life-threatening
allergic reactions and therefore are considered pests of significant
public health importance and incorporated into the pest-specific
claims.
    The Asian giant hornet, Vespa mandarinia, has recently been sighted
in the U.S. At the time EPA developed the pest grouping for ``Bees,
Wasps, Yellowjackets, and Hornets'', this species was not in the U.S.
EPA requests comment on whether there are data to suggest the
representative taxa should cover this species, or alternatively, data
to suggest the opposite.
    18. Carpenter Ants. Carpenter ants are structural pests which also
require the submission of efficacy data. For proposed 40 CFR 158.1782,
EPA is proposing data requirement for a pest group claim ``Carpenter
Ants.'' For the pest group claim, EPA is proposing requiring testing
data on one of the following carpenter ant species: Black carpenter ant
(Camponotus pennsylvanicus), or Florida carpenter ant (Camponotus
floridanus), or Western carpenter ant (Camponotus modoc).
    For bait treatment EPA is proposing a performance standard of 95%
prevention of damage to wood for >=3 years. For ``Non-Structural: Wood
Preservative Treatment,'' EPA is proposing a 100% performance standard
of prevention of damage to wood for >=2 years. And for structural
protection, EPA is proposing a performance standard of 95% prevention
of damage to wood >=5 years.
    For carpenter ants, the SAP suggested adding the carpenter ant
(Camponotus neracticus) as a test species. The Panel also indicated
that more test species might be needed on the list because laboratories
may experience hardship obtaining and maintaining colonies of some of
the species on the list provided. In response EPA notes that there are
three carpenter ant options for testing and that testing would need to
be done on only one of the species. EPA notes that the Camponotus
neracticus is significantly smaller than any of the three options.
Thus, EPA believes that the three proposed test species are better
choices for representative species.
    19. Wood-destroying beetles. For proposed 40 CFR 158.1784, EPA is
proposing data requirements for wood destroying beetles. For products
making a claim against wood-destroying beetles or wood-boring beetles,
EPA is proposing to require testing on three species: Anobiid beetle
(Anobiidae sp.), bostrichid beetle (Bostrichidae sp.), and old house
borer (Hylotrupes bajulus). For products making a claim against true
powderpost beetles, EPA is proposing to require testing on one species
from the Lyctinae subfamily.
    For bait treatment EPA is proposing a performance standard of 95%
prevention of damage to wood for >=3 years. For ``Non-Structural: Wood
Preservative Treatment,'' EPA is proposing a 100% performance standard
of prevention of damage to wood for >=2 years. And for structural
protection, EPA is proposing a performance standard of 95% prevention
of damage to wood >=5 years.
    One public commenter suggested that EPA consider adding a fourth
genus also known as the lyctid beetles (Lyctinae spp.) to represent the
major wood-destroying beetle genera while allowing flexibility to test
three of the four. (Ref. 43). The EPA does not believe that
substituting a lyctid beetle as a representative test species is
appropriate, as these beetles are not likely to cause structural
damage.
    20. Termites. For proposed 40 CFR 158.1786, EPA is proposing data

requirements for the subterranean termite, desert subterranean termite,
Formosan subterranean termite, drywood termite, and dampwood termite.
For products making a claim against termites, EPA is proposing testing
on species from four genera of termites. EPA is proposing to require
testing on:

 Coptotermes formosanus
 And one of the following Reticulitermes species:
Reticulitermes flavipes, or Reticulitermes hesperus, or Reticulitermes
virginicus
 And one of the following arboreal termite species:
Nasutitermes coringer (Motschulsky)
 And one of the following drywood termite species: Cryptotermes
brevis, or Cryptotermes cavifrons, or Incisitermes minor, or
Incisitermes snyderi

    For a claim against arboreal termites, EPA is proposing testing of
one arboreal termite species: Nasutitermes coringer (Motschulsky). For
a claim against dampwood termites, EPA is proposing testing of the
following dampwood termite: Zootermopsis sp. For a claim against
drywood termites, EPA is proposing testing of one of the following
drywood termites: Cryptotermes brevis, or Cryptotermes cavifrons, or
Incisitermes minor or Incisitermes snyderi. For a claim against
subterranean termites, including formosan subterranean termites, EPA is
proposing testing in two genera of termites. Specifically, EPA is
proposing testing on the following Coptotermes species: Coptotermes
formosanus; and one of the following Reticulitermes species:
Reticulitermes flavipes, or Reticulitermes hesperus, or Reticulitermes
virginicus.
    For bait treatment, EPA is proposing a performance standard of 95%
prevention of damage to wood for >=3 years. For ``Non-Structural: Wood
Preservative Treatment'' EPA is proposing a 100% performance standard
of prevention of damage to wood for >=2 years. And for structural
protection, EPA is proposing a performance standard of 95% prevention
of damage to wood >=5 years.
    The SAP suggested adding drywood termite (Incisitermes synderi) as
a test species. EPA is proposing to add Incisitermes snyderi to the
list of representative species for drywood termites. Additionally,
Cryptotermes cavifrons, a species endemic to Florida, would also be an
acceptable representative test species and EPA is proposing to add this
organism as well.
    The SAP and other commenters questioned the standard of ``100%
prevention of damage to wood'' and thought that the lesser 95% or 90%
would be more acceptable. EPA agrees with the comment and is proposing
a 95% prevention of damage to wood standard. However, EPA notes that
what constitutes a 95% standard is dependent on the type of study being
performed. For example, for the standard U.S. Forest Service Concrete
Slab field study, the 95% would be calculated such that any damage
greater than nibbles to surface etching would be considered a failure;
if a single plot had more than one instance of nibbles to surface
etching in any of the standard five evaluation periods, this would also
be a failure. A 95% success rate for the U.S. Forest Service Concrete
Slab (CS) tests would be determined by the combined data for a product,
by rate, in a given year. For non-structural wood preservative
treatments, EPA is proposing a standard of 100% prevention of damage to
wood for >=2 years. Additionally, to be consistent with the majority of
other pests, EPA is proposing the termite standards for direct
applications to pests, surface applications, and spatial applications
will be changed to a performance standard of 90%, consistent with
proposed 40 CFR 158.1704.
    21. Invasive Species. EPA believes treating invasive species
quickly and appropriately is critical, and EPA does not intend to
preclude use of a pesticide product pursuant to FIFRA 2(ee) to treat an
invasive species. EPA believes that pesticide products are an important
tool for managing the spread of an invertebrate invasive species and
the related public health concerns or significant economic impacts. The
availability of pesticide products with proven performance against an
invasive species is important to slowing the spread of the invasive
species.
    Due to the sudden appearance and often rapid spread of invasive
species, except for the pests noted, EPA does not presently intend to
list the specific invasive species for which product performance data
might be deemed necessary. Instead, the submission of product
performance data to support claims for effectiveness against invasive
invertebrate pests will be considered on a case-by-case basis. Given
the expectation of infrequent submission of such an application, a
``case-by-case'' approach is the most suitable. EPA recommends that
applicants consult with the Agency when first considering a submission
to place an invasive species on the label of a pesticide product. As
part of the consultation, EPA would be able to provide information on
protocol development and selection of test species. EPA generally
expects to require product performance data for invasive species that
are similar to the Asian longhorned beetle and emerald ash borer in
that they have the potential to cause significant economic or
ecological damage and the efficacy of products used against them cannot
readily be determined at the time of application.
    This proposal specifies that the Asian longhorned beetle and the
emerald ash borer are two invasive pests for which product performance
data must be submitted. The efficacy of the products used for their
control typically cannot be determined until the season after
application, and the EPA believes it appropriate to continue the
practice of reviewing efficacy data for these invasive species.

VIII. Updates to Subparts U and V

    In addition to the inclusion of product performance data
requirements under the new subpart R, EPA is also proposing to revise
and update the product performance data requirements language for
biochemical and microbial pesticides in subpart U, 40 CFR 158.2070 and
subpart V, 40 CFR 158.2160, in order to clarify the requirements for
products that would be subject to both proposed subpart R and also
subpart U or subpart V.
    Subpart U (biochemical pesticides) and subpart V (microbial
pesticides) currently require that product performance data be
developed, and that each applicant must ensure through testing that the
pesticide product is efficacious when used in accordance with label
directions and commonly accepted pest control practices. Both subparts
also state that EPA may require, on a case-by-case basis, submission of
product performance data for any pesticide product registered or
proposed for registration or amendment (see, 40 CFR 158.2070 and 40 CFR
158.2160). These requirements would not be modified by this proposal.
    Subpart U (biochemical pesticides) and subpart V (microbial
pesticides) also currently require that product performance data be
submitted for each biochemical and microbial pesticide product that
bears a claim to control public health pests, as the term is used in
subparts U and V. This requirement is followed by a non-exhaustive list
of public health pests. This includes pest microorganisms infectious to
humans in any area of the inanimate environment or a claim to control
vertebrates (including but not limited to: Rodents, birds, bats,
canids, and skunks) or invertebrates (including but not limited to:
Mosquitoes and ticks) that may

directly or indirectly transmit diseases to humans.
    This proposal adds additional clarity by including a provision in
subpart U (biochemical pesticides) and subpart V (microbial pesticides)
stating that product performance data must be submitted for each
product that bears a claim against an invertebrate pest that is covered
by subpart R. This provision is intended to be coextensive with the
requirements of subpart R, and broader than the currently existing
requirements in subparts U and V related to ``public health pests'' in
that it would also cover the wood-destroying beetles and invasive
exotic species claims covered by subpart R.
    Additionally, EPA notes that data requirements and the performance
standards that determine the acceptability of data may be modified on a
case-by-case pursuant to the provisions in 40 CFR 158.45 and 40 CFR
158.1707.

IX. Impact of This Proposal on Future and Existing Registrations

    This action, if finalized, will have no immediate effect on
existing registrations unless new information indicates an existing
registration includes claims that are not sufficiently supported. When
an application for registration or amended registration requests to put
a claim(s) on its pesticide product's labeling for effectiveness
against an invertebrate species that is covered by this action, the
application would generally include submission of product performance
data to support those claims for effectiveness.

X. Peer Review

A. Human Studies Review Board

    1. Background. Research with human subjects that is conducted or
supported by the U.S. government is subject to regulations for the
protection of human subjects. These regulations are referred to as the
Common Rule. EPA's codification of the Common Rule appears at 40 CFR
part 26, subpart A. On February 6, 2006 (71 FR 6138) (FRL-7759-8), EPA
published a final rule amending part 26 by adding new subparts (B-Q).
This amendment added, among other parts, Subpart K, which applies
standards similar to those in the Common Rule to third parties (i.e.,
those other than federal agencies and federally-funded researchers)
conducting research with human subjects. Additional amendments to part
26 have been made, most recently in 2019 (84 FR 35315, July 23, 2019)
(FRL-9996-48-ORD). Under EPA's regulation, if the research involves
intentional exposure of a human subject and if the sponsor or
investigator intends to submit the results of the research to EPA in
connection with any action that may be performed by EPA under the
pesticide laws (FIFRA or FFDCA), then the research must comply with the
provisions of 40 CFR part 26; the requirements of EPA's human studies
rule also apply to any research involving intentional exposure of a
human subject to a pesticide, when the results are intended to be
submitted in connection with a regulatory action under any other
statute EPA administers. In addition to establishing protections for
human subjects of research, EPA established the Human Studies Review
Board (HSRB or Board) to review both proposals for new research and
reports of covered human research on which EPA proposes to rely under
the pesticide laws. The HSRB is a federal advisory committee operating
in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C.
app. 2, section 9).
    The HSRB typically includes independent experts in toxicology,
exposure assessment, industrial hygiene, statistics, and bioethics, as
well as an entomologist consultant. The HSRB provides EPA with advice,
information, and recommendations on issues related to both the
scientific and ethical aspects of human subjects research. The major
objectives are to provide review and recommendations on the scientific
and ethical aspects of research proposals and protocols, and reports of
completed research with human subjects; and, when requested, advise on
how to strengthen EPA's programs for protection of human subjects of
research. EPA considers all recommendations from the HSRB before
finalizing its reviews of proposed or final research.
    The HSRB reports to the EPA Administrator through EPA's Science
Advisor. Since 2006, the rigorous independent reviews conducted by EPA
and the HSRB, as mandated by part 26, have resulted in research
protocols designed to result in scientifically-sound data and to ensure
the protection of human subjects involved in the research. In providing
for the establishment of the HSRB, the regulations have reassured the
public that all pesticide research involving intentional exposure to
human subjects undergoes thorough independent and expert review based
on scientific and ethical standards.
    Under 40 CFR part 26, subpart K, protocols for research subject to
the regulation's requirements must be submitted to EPA for review and
evaluation before initiation of the study. The relevant information
that must be included in the proposed research protocol is specified in
40 CFR 26.1125. EPA then evaluates the protocol and makes a
determination about the scientific validity and reliability of the
research as well as examining the ethical aspects of the research, in
accordance with the conditions in 40 CFR 26.1603. EPA submits the
protocol and supporting materials, as well as EPA's science and ethics
reviews of the proposed research to the HSRB for review and comment.
The members of the HSRB review the proposed research. Then in an open
and transparent manner at a public meeting, members of the HSRB ask
additional questions, provide their individual comments, and
participate in a discussion which is documented in meeting minutes.
Each final HSRB report contains the Board's responses to charge
questions posed by EPA, as well as the final, approved advice of the
HSRB. The research cannot be initiated until EPA approves the protocol,
following its consideration of the HSRB's input and recommendations.
The protocol will only be approved if EPA determines that the research
conducted according to the protocol would meet the standards of 40 CFR
26, Subparts K and L. Information on the HSRB, including materials
reviewed and recommendations can be found on the HSRB web page. (Ref.
44).
    Once the research has been conducted, then all of the records
relevant to the research, including raw data and records of ethical
review, are submitted to EPA. EPA examines all submitted materials,
considers the scientific and ethical conduct of the research, and
provides the completed research and its evaluation of the completed
research to the HSRB. The HSRB reviews the documents and discusses them
at a public meeting in the same open and transparent manner. The HSRB
issues a report of their findings following the meeting. EPA may rely
on the results of completed human research involving intentional
exposure of human subjects only if the research meets the standards
referenced in part 26, subpart Q.
    2. Review of EPA's draft guideline 810.3700. In October 2008, EPA
presented to the HSRB a draft guideline titled ``Insect Repellents to
be applied to Human Skin'' for review and evaluation. (Ref. 46). The
HSRB final report (Ref. 46) for that October 2008 meeting included the
HSRB's comments and concerns about the statistical analysis plan
included in the draft guideline.

    Based on the HSRB review and comments, EPA revised the guideline
and presented the revised guideline to the HSRB on June 23, 2010. EPA's
Senior Policy Advisor for the Pesticide Program made a presentation
titled, ``OPP Policy Decisions Regarding Insect Repellent Efficacy
Testing.'' (Ref. 31).
    The HSRB recommended several changes or clarifications for the
revised guideline in its final report, (Ref. 47) including:
     Removal of the maximum-likelihood method requirement in
the data analysis section;
     Clarification of recommendations regarding the use of
positive controls, particularly with respect to the number of controls
and the rationale for including them in the study;
     Careful consideration of recommendations regarding the
recruitment and inclusion of so-called `vulnerable' populations; and
     Encouraging the use of study designs that will enable
investigators to collect data that will allow quantitative measurement
of repellent efficacy in addition to determining the complete
protection time (CPT).
    On August 6, 2010 (75 FR 47592), EPA announced the availability of
the final guideline for Insect Repellents to be Applied to Human Skin
(Guideline 810.3700).
    3. Overall impact of HSRB review. As required by 40 CFR part 26,
the HSRB has reviewed and commented on all protocols for conducting
skin-applied insect repellents as well as the completed studies
conducted according to those protocols. In its final reports, the HSRB
provided recommendations to strengthen EPA's statistical approaches for
calculating CPTs. Additionally, the HSRB's feedback has resulted in
EPA's development of a model to calculate sample sizes for field and
lab testing with mosquitoes and lab testing with ticks, to support
results. At the recommendation of the HSRB, EPA also elected not to
require positive controls.

B. FIFRA Scientific Advisory Panel

    On March 19-20, 2013, EPA presented to the SAP a variety of issues
for their consideration and response concerning the Scientific Issues
Associated with Product Performance Data Needs for Pesticide Products
Claiming Efficacy against Invertebrate Pests of Significant Public
Health or Economic Importance. The meeting announcement, the Agency's
presentations and support documents, public comments, and the comments
by the SAP are available at regulations.gov using the docket identifier
EPA-HQ-OPP-2012-0574. Unit VII of this proposal discusses how comments
from the SAP and public comments informed the data requirements of
proposed subpart R.
    In separate actions EPA has developed and revised testing
guidelines and continues to do so. While this rule refers to these
guidelines, and recommends their use, they are not the subject of
today's proposal. For informational purposes, EPA is providing a
description of SAP meetings relevant to those guidelines.
    1. 1994 meeting. In 1994, EPA held a 2-day meeting of the SAP to
review the Agency's proposed amendments to the data requirements for
pesticide registrations contained in 40 CFR part 158. The SAP was asked
to comment on each data requirement and identify, in their opinion,
which ones were necessary to fully and thoroughly evaluate the
potential hazard of a chemical compound and which ones were not
intrinsically useful in providing practical scientific information. The
review included both comparative product performance data requirements
along with product performance data requirements for public health and
non-public health data requirements. A very complete discussion of the
1994 SAP was presented in the proposed rule for conventional pesticides
(March 11, 2005; 70 FR 12310) (FRL-6811-2).
    2. April 2000 meeting. In April 2000 the SAP was asked to comment
on a draft guideline regarding insect repellents for human skin and
outdoor premises. (Ref. 48).
    3. July 2002 meeting. On July 30-31, 2002, the SAP was asked to
review the design and scientific soundness of the draft guideline
entitled ``Termite Bait Testing.'' EPA's presentations, the draft
guideline, the charge questions, and the Panel's review of the
guideline are available at regulations.gov using the docket identifier
EPA-HQ-OPP-2002-0125.
    4. March 2012 meeting. On March 6-7, 2012, EPA presented to the
SAP, a draft guideline regarding bed bugs. The meeting announcement,
the Agency's presentations and support documents, public comments, and
the comments by the SAP are available at regulations.gov using the
docket identifier EPA-HQ-OPP-2011-1017. After taking the SAP's feedback
into consideration, EPA announced the availability of the final test
guideline, Laboratory Product Performance Testing Methods for Bed Bug
Pesticide Products; OCSPP Test Guideline 810.3900, on June 14, 2017 (82
FR 27254) (FRL-9959-78).
    5. May 2018 meeting. On May 8-10, 2018, EPA presented to the SAP
for their consideration and response scientific issues associated with
proposed revisions to two EPA Test Guidelines 810.3100 (Soil Treatment
for Imported Fire Ants), and Guideline 810.3500 (Premises Treatment),
for Red Imported Fire Ants (RIFA). These guidelines were originally
published in March 1998.
    The proposed premises treatment guideline revisions presented to
the SAP contained recommended test methodologies for a wide range of
products intended to kill, control, flush, and/or knockdown
invertebrate premises pests, such as cockroaches, ticks, mosquitoes,
flies, and wasps. The guideline did not cover treatment of livestock or
pets, wide area-mosquito control, or bed bug products. In addition to
guidance for testing efficacy of direct pesticide application to pests,
residual treatments, and cockroach and fly baits in the laboratory, the
proposed guideline also included field testing methods for outdoor
misting systems, Hymenoptera nest treatments, and outdoor foggers.
Methods for resistance ratio determination and characterization of pest
population strain susceptibility were also described.
    The proposed RIFA treatment guideline revisions contained
recommended test methodologies for evaluating the performance of
pesticide products for the treatment and control of red imported fire
ant colonies/mounds. The guideline did not cover premises treatments
for RIFA workers/foragers, such as direct application to pests. Field
tests for both mound- and area-applied pesticide products were
proposed, along with accompanying laboratory studies for baits, barrier
treatments, and insect growth regulators.
    The meeting announcement, the Agency's presentations and support
documents, and public comments are available at regulations.gov using
the docket identifier EPA-HQ-OPP-2017-0693. In September of 2019, EPA
published the final Product Performance Test Guidelines OCSPP 810.3500:
Premises Treatments; Background information, the draft guideline, and
charge questions developed by EPA are available at https://archive.epa.gov/scipoly/sap/meetings/web/html/040500_mtg.html.
    7. June 2019 meeting. On June 11-14, 2019, the SAP reviewed EPA's
proposed guidelines for Efficacy Testing of Topically Applied
Pesticides Used Against Certain Ectoparasitic Pests on Pets. The
meeting announcement, the Agency's presentations and support documents,
public comments, and the comments by the SAP are available at

regulations.gov using the docket identifier EPA-HQ-OPP-20190161.

XI. Request for Comments

    The Agency invites the public to provide comment on the proposed
requirements and their basis. Specifically included within the Agency's
requests for comments are suggestions which can be supported by
scientific data for the Agency to consider during the development of
the final rule. Specific comments are requested for:
    1. Definitions. The Agency welcomes comment on the proposed
definitions. The Agency also welcomes suggestions on additional
definitions that may be needed to help clarify what is required in the
regulations.
    2. Representative test species. The proposed rule includes
taxonomic categories of invertebrates which require more than one
species to be tested to support a general claim for that pest group.
The representative taxa were selected on the basis of vigor of the pest
species and the likely ability of the species to serve as an adequate
surrogate for other pests in the group. The selection of representative
taxa was informed by the 2013 SAP.
    3. Performance standards. The Agency welcomes specific comments on
performance standards. The Agency would need to see scientifically
sound data to support any recommendations for performance standards
that differ from those proposed. The Agency believes requiring data
showing the pesticide meets a specified threshold level (performance
standard) of efficacy is the best means of addressing potential
consequences which could occur through the use of ineffective
pesticides intended for use against pests that transmit disease.
    4. Economic analysis. The Agency also welcomes public comment on
its economic analysis of the proposed rule, as well as on its
underlying assumptions, economic data, and high and low-cost options
and alternatives. Describe any assumptions and provide any technical
information and data used in preparing your comments. Explain estimates
in sufficient detail to allow for it to be reproduced for validation.
EPA's underlying principle in developing the proposed revisions has
been to strike an appropriate balance between the need for adequate
data to make the statutorily mandated determinations and informed risk
management decisions, while minimizing data collection burdens on
regulated community required to support product performance data
requirements. In particular, EPA would appreciate public comment on the
magnitude of the savings in discovery costs discussed on page 29 of the
cost analysis.

XII. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, 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 these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.

1. US EPA. Cost Analysis of the Proposed Product Performance Rule,
prepared by the Biological and Economic Analysis Division, Office of
Pesticide Programs, available in docket: EPA-HQ-OPP-2020-0124.
2. US EPA. Pesticide Registration (PR Notice) Notice 2002-1,
available at https://www.epa.gov/sites/production/files/2014-04/documents/pr2002-1.pdf at 2 (accessed March 6, 2020); see also
Public Review Draft: Pesticide Registration (PR Notice) 2020-[X],
Draft List of Pests of Significant Public Health Importance--Revised
2020, docket EPA-HQ-OPP-2020-0260.
3. US EPA. PRN 96-7 Termiticide Labeling, available at https://www.epa.gov/pesticide-registration/prn-96-7-termiticide-labeling
(accessed March 13, 2020).
4. United States Public Health Service. Public Health Report. 1923
Aug 3; 38(31): 1747-1814.
5. Scott, Thomas and Willem Takken. Feeding strategies of
anthropophilic mosquitoes result in increased risk of pathogen
transmission. Trends in Parasitology March 2012, Vol. 28, No. 3.
6. Eisen, Lars. Pathogen transmission in relation to duration of
attachment by Ixodes scapularis ticks, Ticks and Tick-borne
Diseases.
7. US EPA. Bed Bugs, Get them out and Keep them Out, available at
https://www.epa.gov/bedbugs (accessed March 6, 2020).
8. US EPA and CDC. Joint statement on bed bug control in the United
States from the U.S. Centers for Disease Control and Prevention
(CDC) and the U.S. Environmental Protection Agency (EPA); available
at https://stacks.cdc.gov/view/cdc/21750/Email (accessed March 19,
2020).
9. Su N-Y, Scheffrahn RH (2000). Termites as pests of buildings. In:
Abe T, Bignell DE, Higashi M (eds) Termites: Evolution, sociality,
symbioses, ecology. Kluwer, Boston, pp 437-453.
10. Peterson CJ, Wagner TL, Shelton TG, Mulrooney JE (2008). A
historic pest: 90 years of USDA publications reveal changes in
termite management. Pest Manag Prof 76(2):25, 28-30, 32.
11. US EPA. Office of Pesticide Programs, Label Review Manual,
available at https://www.epa.gov/pesticide-registration/label-review-manual (accessed March 13, 2020).
12. US EPA. Product Performance Guideline 810.1000, Overview,
Definitions, and General Considerations, available at https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-810-product-performance-test-guidelines (accessed March 6, 2020).
13. CDC. Division of Vector Borne Infectious Diseases: West Nile
Virus Fact Sheet available at https://www.cdc.gov/westnile/resources/pdfs/wnvFactsheet_508.pdf, (accessed March 9, 2020).
14. CDC. Zika Virus, Statistics and Maps; available at https://www.cdc.gov/zika/reporting/index.html (accessed March 6, 2020); CDC,
Zika Virus, available at https://www.cdc.gov/zika/index.html
(accessed March 6, 2020).
15. CDC. Lyme Disease: Data and Surveillance, available at https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html (accessed March 19, 2020).
16. M.L. Wilson, J.F. Levine, and A. Spielman. Effect of deer
reduction on abundance of the deer tick (Ixodes dammini), Yale J
Biol Med. 1984 Jul-Aug; 57(4): 697-705.
17. David Cameron Duffy, Scott R. Campbell, Dara Clark, Chris
Dimotta, Susan Gurney. Ixodes scapularis (Acari: Ixodidae) Deer Tick
Mesoscale Populations in Natural Areas: Effects of Deer, Area, and
Location, Journal of Medical Entomology, Volume 31, Issue 1, 1
January 1994, Pages 152-158, https://doi.org/10.1093/jmedent/31.1.152.
18. CDC. Lyme Disease: Treatment, available at https://www.cdc.gov/lyme/treatment/index.html (accessed March 6, 2020).
19. CDC. Signs and Symptoms of Untreated Lyme Disease, available at
http://www.cdc.gov/lyme/signs_symptoms/index.html (accessed March 9,
2020).
20. CDC. Rocky Mountain Spotted Fever: Signs and Symptoms, available
at https://www.cdc.gov/rmsf/symptoms/index.html, (accessed March 6,
2020); CDC.
21. CDC. Rocky Mountain Spotted Fever: Information for Health Care
Providers, available at https://www.cdc.gov/rmsf/healthcare-providers/index.html (accessed March 6, 2020).
22. CDC. Lyme Disease: Preventing Tick Bites on People, available at
https://www.cdc.gov/lyme/prev/on_people.html (accessed March 6,
2020).
23. CDC. Division of Vector Borne Infectious Diseases: West Nile
Virus (WNV) Fact Sheet available at https://www.cdc.gov/westnile/resources/pdfs/wnvFactsheet_508.pdf (accessed March 6, 2020).
24. Emerald Ash Borer Information Network, available at http://www.emeraldashborer.info/about-eab.php (accessed March 9, 2020).
25. USDA. Emerald Ash Borer, available at https://
www.aphis.usda.gov/aphis/

ourfocus/planthealth/plant-pest-and-disease-programs/pests-and-
diseases/emerald-ash-borer (accessed March 9, 2020).
26. USDA. Asian Long-Horned Beetle, available at https://www.invasivespeciesinfo.gov/profile/asian-long-horned-beetle,
(accessed March 9, 2020).
27. NRS. Economic Impacts of Non-Native Forest Insects in the
Continental United States, available at https://www.nrs.fs.fed.us/pubs/38719 (accessed March 9, 2020).
28. US EPA. Technical Support Document Scientific Issues Associated
with Product Performance Data Needs for Pesticide Products Claiming
Efficacy against Invertebrate Pests of Significant Public Health or
Economic Importance Submitted to the FIFRA Scientific Advisory Panel
for Review and Comment March 19-21, 2013 (Hereinafter ``TSD''),
available in docket: EPA-HQ-OPP-2012-0574-0002, Appendix 1, Tables I
and II.
29. US EPA. FIFRA Scientific Advisory Panel, Meeting Minutes and
Final Report for the March 19-21, 2013 Scientific Advisory Panel,
available at https://www.epa.gov/sites/production/files/2015-06/documents/031913minutes.pdf (accessed April 9, 2020).
30. World Health Organization (WHO). Guidelines for Efficacy Testing
of Mosquito Repellents for Human Skin, available at http://whqlibdoc.who.int/hq/2009/WHO_HTM_NTD_WHOPES_2009.4_eng.pdf
(accessed March 23, 2020).
31. US EPA. OPP Policy Decisions Regarding Insect Repellent Efficacy
Testing, (prepared for June 23, 2010, Human Subjects Research Board
Meeting).
32. USDA. National Invasive Species Information Center, available at
https://www.invasivespeciesinfo.gov/ (accessed April 29, 2020).
33. Consumer and Specialty Products Association (CSPA). Comment
submitted by Beth Law, CSPA, March 15, 2013, EPA-HQ-OPP-2012-0574-
0014.
34. USDA. Victor Borne Diseases: Cattle Fever Ticks, available at
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information/cattle-disease-information/cattle-vector-borne-diseases (accessed March 9, 2020).
35. Bovine Babesiosis, available at cfsph.iastate.edu/factsheets/pdfs/bovine_babesiosis.pdf (accessed March 24, 2020).
36. S.C. Johnson & Son, Inc. Comment submitted by Jill Geyser, S.C.
Johnson & Son, Inc., March 9, 2013, EPA-HQ-OPP-2012-0574-0011.
37. UF IFAS. Featured Creatures: Human Bot Fly, available at http://entnemdept.ufl.edu/creatures/misc/flies/human_bot_fly.htm (accessed
March 9, 2020).
38. USDA. National Agricultural Library, New World Screwworms,
available at https://www.nal.usda.gov/exhibits/speccoll/exhibits/show/stop-screwworms--selections-fr/introduction (accessed March 9).
39. US EPA. EPA's Guideline 810.3700, entitled, ``Insect Repellents
to be Applied to Human Skin,'' available at https://www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-810-product-performance-test-guidelines (accessed July 1, 2020).
40. Comment submitted by Dudley Hoskins, Responsible Industry for a
Sound Environment, March 10, 2013, EPA-HQ-OPP-2012-0574-0009.
41. Comment submitted by Beth Law, Consumer and Specialty Products
Association, March 15, 2013, EPA-HQ-OPP-2012-0574-0014.
42. CDC. Parasites-Leishmaniasis, available at https://www.cdc.gov/parasites/leishmaniasis/index.html (accessed March 16, 2020).
43. Comment submitted by Brian Forschler, Termiticide Scientific
Review Panel, March 19, 2013, EPA-HQ-OPP-2012-0574-0016.
44. US EPA. Science Adviser Programs: Human Studies Review Board,
available at https://www.epa.gov/osa/human-studies-review-board
(accessed April 1, 2010).
45. US EPA. Draft Guideline 810.3700, Insect Repellents to be
applied to Human Skin https://archive.epa.gov/osa/hsrb/web/pdf/guidelines-for-performance-testing-of-skin-applied-insect-repellents-9.23.08.pdf (accessed April 1, 2020).
46. US EPA. October 21-22, 2008 EPA Human Studies Review Board
Meeting Report, available at https://archive.epa.gov/osa/hsrb/web/pdf/october2008hsrbbfinaldraftreport12808.pdf (accessed April 9,
2020).
47. US EPA. EPA Human Studies Review Board Meeting Report, June 23,
2010. Available at https://archive.epa.gov/osa/hsrb/web/pdf/june2010finalreport090910.pdf (accessed April 14, 2020).
48. US EPA. Background Information, the Draft Guideline, and Charge
Questions Developed by EPA, available at https://archive.epa.gov/scipoly/sap/meetings/web/html/040500_mtg.html.
49. US EPA. ``Proposed Rule-related ICR Amendment for Pesticide
Product Performance Data Requirements for Products Claiming Efficacy
Against Certain Invertebrate Pests'' (RIN 2070-AJ49), EPA ICR No.:
0277.20 and OMB Control No.: 2070-[tbd]. November 2020.

XIII. FIFRA Review Requirements

    Pursuant to FIFRA section 25(a), EPA submitted the draft proposed
rule to the Secretary of Agriculture (USDA) and the FIFRA SAP for
review. A draft of the proposed rule was also submitted to the
appropriate Congressional Committees.

XIV. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes made in response to OMB recommendations
have been documented in the docket. EPA prepared an analysis of the
potential costs and benefits associated with this action (Ref. 1) which
is summarized in more detail in Unit I.E. This analysis is available in
the docket.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et
seq. The Information Collection Request (ICR) document that EPA
prepared is assigned EPA ICR No. 0277.20 and OMB Control No.: 2070-0060
(Ref. 49). You can find a copy of the ICR in the docket and it is
briefly summarized here.
    The information collection activities in this proposed rule are
associated with the codification of efficacy data requirements against
certain invertebrate pests. These information collection activities are
activities associated with the application for a new or amended
registration of a pesticide and are currently approved by OMB under OMB
Control No. 2070-0060 (EPA ICR No. 0277). As such, this ICR is intended
to amend that existing ICR at the final rule stage, incorporating the
information collection activities attributable to this proposed rule,
including a reduction in transaction costs associated with a clear
codification of the product performance data requirements for certain
invertebrate pests.
    Respondents/affected entities: There are three groups impacted by
the rule. Chemical producers (NAICS 32532), colleges, universities, and
professional schools (NAICS code 611310), and research and development
labs and services (NAICS code 541712).
    Respondent's obligation to respond: These data must be submitted
for the applicant to receive the desired pesticide registration or
label claim. Authorizing legislation is contained in Section 3 of FIFRA
(7 U.S.C. 136). The implementing regulations specific to the product
performance data requirements are contained in 40 CFR part 158.

    Estimated number of respondents: EPA estimates that registrants
submit 60 data packages to the Agency annually for efficacy review.
Some registrants may submit multiple data packages per year. Under this
rule the number of submissions may decline--and therefore the number of
respondents may also decrease.
    Frequency of response: On occasion.
    Total estimated burden: The proposed rule is expected to reduce
burden hours by 4,683 annually, including 4,515 hours from reduced
paperwork burden associated with data generation and 168 hours from
reduced paperwork burden associated with the application process.
Burden is defined at 5 CFR 1320.3(b). EPA already accounts for the
activities associated with the proposed rule in the currently approved
ICR, which covers most activities associated with new and amended
registrations; EPA estimates a total annual respondent burden of 1.5
million hours for all these activities. As discussed in the Proposed
Rule-related ICR Amendment (Ref. 49), 483,000 of those hours are
paperwork burden from data generation for new products, and 102,000 of
those hours are paperwork burden from application for new and amended
products.
    Total estimated cost: The estimated burden reduction is expected to
reduce burden cost by $330,000 annually, including $315,000 from
reduced paperwork burden associated with data generation and $15,000
from reduced paperwork burden associated with the application process,
which includes $0 annualized capital or operation and maintenance
costs. EPA already accounts for the activities associated with the
proposed rule in the currently approved ICR, which covers most
activities associated with new and amended registrations; EPA estimates
a total annual respondent burden of $109 million for all these
activities. As discussed in the Proposed Rule ICR (Ref. 49), $33.7
million of that cost is paperwork burden from data generation for new
products, and $9.3 million of that cost is paperwork burden from
application for new and amended products.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on the Agency's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to the EPA using the docket identified at
the beginning of this rule. You may also send your ICR-related comments
to OMB's Office of Information and Regulatory Affairs via email to
<EMAIL_ADDRESS>Attention: Desk Officer for the EPA.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, the impact of concern
is any significant adverse economic impact on small entities. An agency
may certify that a rule will not have a significant economic impact on
a substantial number of small entities if the rule relieves regulatory
burden, has no net burden, or otherwise has a positive economic effect
on the small entities subject to the rule. EPA's small entity analysis
suggests that the greatest impact, and the most potential cost savings,
would accrue to small entities and new registrants. While large,
established registrants have experience with the registration process
and are aware of EPA's data requirements or have the means to determine
the appropriate studies, new and small registrants without that
experience may bear significant costs of acquiring this information.
The registrants would have easier access to the data requirements, and
the reduction in information acquisition costs would be largest for
those registrants with the greatest information acquisition needs.
Thus, EPA anticipates that the proposed rule would result in cost
savings, particularly for small and first-time registrants. While the
affected NAICS codes contain up to 5,438 small entities, EPA does not
expect all entities to experience cost savings in all years as a result
of this proposed rule. As the cost analysis (Ref. 1) describes, a
sample of 30 applications was selected at random. These applications
were submitted by 16 different firms, four of which EPA was able to
identify as small businesses according to the Small Business
Administration Employees or Revenue Thresholds. About 60 packages are
received annually by EPA for control claims. Therefore, EPA expects
that, on average, approximately ten small entities will experience cost
savings each year as a result of this proposed rule.
    While not every element of the proposed rule would result in
savings for registrants, EPA conservatively estimates that the rule
would result in $1 million in annual reductions in registrant
expenditures on the process of receiving label claims against public
health, wood destroying, and invasive species pests, equivalent to
about $17,000 in savings per data package submitted to the Agency and
about $5,500 per registrant in annual savings I have therefore
concluded that this action will relieve regulatory burden for all
directly regulated small entities. The basis for this determination is
presented in the small entity analysis prepared as part of the cost
analysis for the proposed rule (Ref. 1), which is summarized in Unit
I.E, and a copy is available in the docket for this rulemaking. We have
therefore concluded that this action will relieve regulatory burden for
all directly regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and will not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments. The proposed rule would primarily affect
the private sector, i.e., pesticide registrants. The rule is not
expected to result in expenditures by State, local, and Tribal
governments, in the aggregate, or by the private sector, of $100
million or more (when adjusted annually for inflation) in any one year.
Accordingly, this proposed rule is not subject to the requirements of
sections 202, 203, or 205 of UMRA. The cost analysis for this action is
summarized in Unit I.E. and is available in the docket.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), 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.

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

    This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on tribal governments, on the
relationship between the Federal government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
government and Indian tribes. At present, no Tribal governments hold,
or have applied for, a pesticide registration. Thus, Executive

Order 13175 does not apply to this action.

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

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not otherwise been designated as a significant
energy action by the Administrator of the Office of Information and
Regulatory Affairs.

I. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

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

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. The Agency notes, however,
that the proposed data requirements will provide data that will be used
to assure that pesticide products perform effectively if claiming
effectiveness against an invertebrate pest of significant public health
or economic importance, and to address both health concerns and
economic consequences stemming from pesticide products that might not
perform as claimed on the label, including consequences for sensitive
subpopulations and minority or low-income communities.

Lists of Subjects in 40 CFR Part 158

    Environmental protection, administrative practice and procedure,
agricultural and non-agricultural, pesticides and pests, reporting and
recordkeeping requirements.

Jane Nishida,
Acting Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend 40
CFR part 158 as follows:

PART 158--DATA REQUIREMENTS FOR PESTICIDES

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

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

0
2. In Sec.  158.1, revise paragraph (c) to read as follows:

Sec.  158.1  Purpose and scope.

* * * * *
    (c) Scope of individual subparts. (1) Conventional pesticides.
Subparts A, B, C, D, E, F, G, K, L, N, O, and R apply to conventional
pesticides.
    (2) Biochemical pesticides. Subparts A, B, E, R, and U apply to
biochemical pesticides.
    (3) Microbial pesticides. Subparts A, B, E, R, and V apply to
microbial pesticides.
    (4) Antimicrobial pesticides. Subparts A, B, C, D, E, R, and W of
this part apply to antimicrobial pesticides.
0
3. Revise the heading for subpart E to read as follows:

Subpart E--Product Performance for Products Claiming Effectiveness
Against Vertebrate Pests, Products With Prion-related Claims, and
Products for Control of Organisms Producing Mycotoxins

0
4. Add section subpart R to read as follows:
Subpart R--Product Performance for Products Claiming Effectiveness
Against Invertebrate Pests
Sec.
158.1700 General requirements.
158.1701 Definitions.
158.1703 Application categories.
158.1704 Performance standards for data acceptability.
158.1705 Test guidelines.
158.1707 Data requirement modifications.
158.1708 Invasive species claims.
158.1709 Invertebrate disease vector claims.
158.1710 Structural and wood-destroying pest claims.
158.1712 Mites (excluding chiggers).
158.1714 Chiggers.
158.1718 Ticks.
158.1722 Scorpions.
158.1726 Spiders.
158.1732 Centipedes.
158.1736 Lice.
158.1740 Fleas.
158.1744 Cockroaches.
158.1748 Keds, screwworms, and bot flies.
158.1752 Filth flies.
158.1756 Mosquitoes.
158.1760 Biting flies.
158.1768 Bed bugs.
158.1772 Conenose bugs and kissing bugs.
158.1776 Ants (excluding carpenter ants).
158.1780 Bees, wasps, yellowjackets, and hornets.
158.1782 Carpenter ants.
158.1784 Wood-destroying beetles.
158.1786 Termites.

Subpart R--Product Performance for Products Claiming Effectiveness
Against Invertebrate Pests

Sec.  158.1700  General requirements.

    (a) General. Each applicant must ensure through testing that their
product is efficacious when used in accordance with label directions
and commonly accepted pest control practices. The Agency may require,
as specified herein and on a case-by-case basis, submission of product
performance data for any pesticide product registered or proposed for
registration or amendment.
    (1) Test substance. All product performance testing is performed
using the end-use product.
    (2) Test organism. All product performance testing must report the
species tested.
    (3) Testing. All products are to be tested to support the claim(s)
made on the labeling of the pesticide product.
    (4) Data requirements. To determine the specific product
performance data required to support the registration of each pesticide
product, the applicant must refer to the applicable sections of this
subpart.
    (b) Product performance data submission. Each product that bears a
claim subject to this subpart, must be supported by submission of
product performance data, as listed in this subpart. This product
performance data must be submitted with any application for
registration or amended registration. For the pest-specific claims
listed in this subpart, data must be for the species specified to
support the claim.

Sec.  158.1701  Definitions.

    Definitions. The following terms are defined for purposes of this
subpart.
    Complete protection time (CPT) means the time from application of a
skin-applied insect repellent until efficacy failure, which is
described in Product Performance Test Guideline 810.3700--Insect
Repellents to be Applied to Human Skin.
    Introduction means the intentional or unintentional escape,
release, dissemination, or placement of a species into an ecosystem as
a result of human activity.

    Invasive species means with respect to a particular ecosystem, any
species that is not native to that ecosystem, and whose introduction
does or is likely to cause economic or environmental harm or harm to
human health.
    Performance standard means a benchmark or reference against which
the efficacy of the pesticide is compared (including, but not limited
to, the ability of the pesticide product to control, kill, or repel an
invertebrate pest species).
    Pest group labeling claim means a claim or statement on the
labeling of the pesticide product that the product is effective against
a group of related species or taxa demonstrating adequate similarity in
basic biology and life history characteristics to permit identification
of representative test species for the entire assemblage of taxa.
    Pest-specific labeling claim means a claim or statement on the
labeling of the pesticide product that the product is effective against
a particular arthropod species, such as German cockroach or house fly.
    Pest sub-group labeling claim means a claim or statement on the
labeling of the pesticide product that the product is effective against
a set of related species or taxa demonstrating adequate similarity in
basic biology and life history characteristics to permit identification
of representative test species and part of a larger identified
taxonomic grouping (e.g., Biting flies) that includes other pest
species, which may or may not have a proposed pest group.
    Skin-applied insect repellent means a product intended to disrupt
the host-seeking behavior of insects or other arthropods, driving or
keeping them away from treated human skin. The repellent product, such
as liquid, lotion, or spray, is intended to be applied directly to
human skin. Efficacy of skin-applied insect repellents is expressed as
complete protection time.
    Species means a group of organisms all of which have a high degree
of physical and genetic similarity, generally interbreed only among
themselves, and show persistent differences from members of allied
groups of organisms.
    Wood-destroying applies to pests that feed on or nest in wood, and
therefore are highly destructive to wood buildings or structures, and
stored lumber. The impact on the structural integrity of buildings can
represent significant economic or safety concerns given the costs of
remediation.
    Vector means any organism capable of transmitting the causative
agent of human and/or animal disease, including but not limited to
mosquitoes and ticks.

Sec.  158.1703  Application categories.

    The following terms are defined for purposes of this subpart.
    Bait treatment means a pesticide product intended to be ingested by
the target pest that kills or controls an invertebrate pest such as
ants, cockroaches, or termites. This is normally through the insect
feeding on the product directly, but may also include products which
the target will contact and later ingest during grooming/cleaning. The
attractiveness of these products is through the use of a palatable food
base, however they may also incorporate an attractant (e.g. pheromone)
which is intended to attract the target pests over a greater distance.
    Soil-applied termiticides means pesticide products that are applied
to the soil beneath and/or adjacent to the structure, pre- or post-
construction, to kill or control termites. Treatments can be preventive
(i.e., to provide structural protection before a termite infestation is
present) or remedial (i.e., to kill and control a termite infestation
when present).
    Spatial repellents include treatments of both indoor and outdoor
sites where the product is applied into the air rather than onto a
surface or the skin in order to drive away insects or other arthropods
from that space. They are intended to repel the target pest through the
dispersal of pesticide into the atmosphere of a room or other open
space.
    Structural protection means the prevention of termite or other
wood-destroying pest activity in an entire structure as the result of
an application of a pesticide product.

Sec.  158.1704  Performance standards for data acceptability.

    (a) General. The claim stated on the pesticide product labeling
(such as knockdown, control, mortality, or repellency) determines the
performance standard that must be met. In the absence of specific pest/
labeling claims/performance standards specified in Sec. Sec.  158.1708
through 158.1799, the performance standards of paragraphs (b) and (c)
of this section apply.
    (b) Skin-applied insect repellent labeling claims. (1) For skin-
applied insect repellent labeling claims, the performance standard must
be greater than or equal to 2-hours complete protection time.
    (2) Any testing required under this part which involves any human
subjects must comply with all applicable requirements under 40 CFR part
26. For example, 40 CFR part 26 requirements are pertinent to the part
158 testing requirement if the testing involves intentional exposure of
human subjects. Protocols for such testing must be submitted to EPA for
review prior to study initiation. Those protocols determined by EPA to
involve intentional exposure of human subjects also require review by
EPA's Human Studies Review Board (HSRB)) prior to study initiation. If
you are uncertain about the applicability of the 40 CFR part 26
requirements to this 40 CFR part 158 testing requirement or uncertain
about the nature of your planned testing (such as, for example, whether
the testing would involve intentional exposure of human subjects or
whether the testing would be an observational study), you should
contact the Agency prior to initiating the testing.
    (c) Labeling claims for products other than skin-applied insect
repellents. Unless otherwise specified in Sec. Sec.  158.1710 through
158.1786, for pesticides other than skin-applied insect repellents, the
performance standard for a product performance claim against a pest
must be greater than or equal to 90 percent, except for non-wearable
spatial repellents where the performance standard is greater than or
equal to 75 percent.

Sec.  158.1705  Test guidelines.

    EPA has published the Harmonized Test Guidelines, which set forth
the recommended approach to generate the data required in this subpart.
The Product Performance Guidelines (Series 810, Group C--Invertebrate
Control Agent Test Guidelines) are available on the Agency's website.
These guidelines cover some, but not all, of the tests that would be
used to generate data under this subpart. In instances where there is a
conflict between one of the Harmonized Test Guidelines and the
provisions of this subpart, this subpart will control.

Sec.  158.1707  Data requirement modifications.

    The data requirements (including the performance standards
associated with the data requirements) specified in this subpart as
applicable to a category of products will not always be appropriate for
every product in that category. Data requirements may, on a case-by-
case basis, be adjusted by EPA in response to requests for novel
technologies or products that have unusual physical, chemical, or
biological properties or atypical use patterns which would make a
particular data requirement, or data performance standard,
inappropriate. Requests for such data requirement modifications must be
submitted the same manner as waiver requests submitted under 40 CFR
158.45. EPA

will respond in writing to those requests. The Agency may modify data
requirements it finds are inappropriate for the pesticide in question,
but will ensure that sufficient data are available to make the
determinations required by the applicable statutory standards.

Sec.  158.1708  Invasive species claims.

    (a) General. In addition to those species specified in paragraph
(b) of this section, if an application for registration or amended
registration requests a labeling claim for effectiveness against an
invasive invertebrate species, then on a case-by-case basis, EPA may
require submission of product performance data and establish
performance standards for those data to support those claims for
effectiveness.
    (b) Specific. Applications for registration or amended registration
requests for a labeling claim for the emerald ash borer, Agrilus
planipennis, or Asian longhorned beetle, Anoplophora glabripennis, must
be accompanied by product performance data to support those claims for
effectiveness.

Sec.  158.1709  Invertebrate disease vector claims.

    If an application for registration or amended registration requests
a labeling claim specific to a disease vector (such as repels
mosquitoes that may carry West Nile virus), then submission of testing
conducted with the species specific to the disease vector claim and
subject to specific performance standards is required even if the test
species is not specifically required in Sec. Sec.  158.1712 through
158.1786.

Sec.  158.1710  Structural and wood-destroying pest claims.

    If an application for registration or amended registration requests
a labeling claim specific to a structural or wood-destroying pest not
identified in Sec. Sec.  158.1782 through 158.1786, EPA may require
submission of product performance data, with testing on that specific
pest and subject to specific performance standards, to support those
claims for effectiveness.

Sec.  158.1712  Mites (excluding chiggers).

    (a) General. The tables and test notes in this section apply to
dust, human itch or scabies, and dog follicle mites. The claim stated
on the pesticide product labeling determines the required test species.
The required test species for a specific type of mite claim appear in
paragraph (b) of this section and the required performance standards
appear in paragraph (c) of this section.
    (b) Test species. For pesticide products making a claim against
mites, the required test species appear in the following table.

Table 1 Paragraph (b)--Required Test Species for Products Making a Claim
                              Against Mites
                          [Excluding Chiggers]
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Dog Follicle Mite.................  Dog follicle mite (Demodex canis).
Dust Mite.........................  Testing on one of the following
                                     species is required:
                                    American house dust mite
                                     (Dermatophagoides farinae) OR
                                     European house dust mite
                                     (Dermatophagoides pteronyssinus).
Human Itch or Scabies Mite........  Human itch mite (Sarcoptes scabiei).
------------------------------------------------------------------------

    (c) Performance standards. (1) For the dog follicle mite, a
performance standard of 100 percent is required.
    (2) For the human itch or scabies mite, a performance standard of
100 percent is required.

Sec.  158.1714  Chiggers.

    If the pesticide product labeling makes a claim against chiggers,
then testing is required using the following test species: Chigger
(Trombicula alfreddugesi).

Sec.  158.1718  Ticks.

    (a) General. The table and test notes in this section apply to hard
ticks (including cattle ticks) and soft ticks. The claim stated on the
pesticide product labeling determines the required test species. The
required test species for a specific type of tick claim appear in
paragraph (b) of this section. Specific parameters that apply to
individual tests appear in paragraph (c) of this section. For a claim
against any specific species of ``ticks'' that individual species and
all the listed representative species for ``ticks'' must be tested, but
not the representative species for cattle ticks or soft ticks. Claims
against ticks in association with tick borne diseases are also subject
to the requirements in Sec.  158.1709.
    (b) Test species. For pesticide products making a claim against
ticks, the required test species appear in the following table.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                           Claim Against Ticks
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Ticks.............................  Testing on a total of three hard
                                     tick species is required:
                                    Blacklegged tick (Ixodes scapularis)
                                     AND Lone star tick (Amblyomma
                                     americanum)
                                    AND one of the following three
                                     species:
                                    American dog tick (Dermacentor
                                     variabilis) OR Brown dog tick
                                     (Rhipicephalus sanguineus) OR Rocky
                                     Mountain wood tick (Dermacentor
                                     andersoni).
Cattle Ticks......................  Testing on one of the following
                                     species is required:
                                    Southern cattle tick (Rhipicephalus
                                     microplus) OR Cattle fever tick
                                     (Rhipicephalus annulatus).
Soft Ticks........................  Soft tick (Ornithodoros hermsi).
------------------------------------------------------------------------

    (c) Specific parameters. The following parameters are required.
    1. For products applied to dogs, testing is required on three
species: Blacklegged tick (Ixodes scapularis), American dog tick
(Dermacentor variabilis), and Brown dog tick (Rhipicephalus
sanguineus).
    2. For products applied to cats, testing is required on three
species: Blacklegged tick (Ixodes scapularis), Lone star tick
(Amblyomma americanum), and American dog tick (Dermacentor variabilis).

Sec.  158.1722  Scorpions.

    If the pesticide product labeling makes a claim against scorpions,
then testing is required using the following test species: Striped bark
scorpion (Centruroides vittatus).

Sec.  158.1726  Spiders.

    (a) General. The table in this section applies to spiders. The
product labeling claim determines the required test species. The
required test species for spider labeling claims appear in paragraph
(b) of this section.
    (b) Test species. For products making a claim against spiders, the
test species for labeling claims appear in the following table.

 Table 1 of 158.1726--Required Test Species for Products Making a Claim
                             Against Spiders
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Spiders...........................  Testing on two species is required:
                                       Brown recluse spider (Loxosceles
                                        reclusa)
                                    AND one of the following species is
                                     required:
                                       Northern black widow spider
                                        (Latrodectus variolus) OR
                                        Southern black widow spider
                                        (Latrodectus mactans) OR Western
                                        black widow spider (Latrodectus
                                        hesperus).
------------------------------------------------------------------------
                          Pest Sub-Group Claims
------------------------------------------------------------------------
Black Widow Spiders...............  Testing on one of the following
                                     species is required:
                                       Northern black widow spider
                                        (Latrodectus variolus) OR
                                        Southern black widow spider
                                        (Latrodectus mactans) OR Western
                                        black widow spider (Latrodectus
                                        hesperus).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Brown recluse spider..............  Brown recluse spider (Loxosceles
                                     reclusa).
Brown widow spider................  Brown widow spider (Latrodectus
                                     geometricus).
Northern black widow spider.......  Northern black widow spider
                                     (Latrodectus variolus).
Southern black widow spider.......  Southern black widow spider
                                     (Latrodectus mactans).
Western black widow spider........  Western black widow spider
                                     (Latrodectus hesperus).
------------------------------------------------------------------------

Sec.  158.1732  Centipedes.

    (a) General. The table in this section applies to centipedes. The
product labeling claim determines the required test species. The
required test species for a labeling claim appears in paragraph (b) of
the section.
    (b) Test species. For products making a claim against centipedes,
the required test species for a labeling claim is set forth in the
following table.

 Table 1 of 158.1732--Required Test Species for Products Making a Claim
                           Against Centipedes
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Centipedes........................  Testing on one of the following
                                     species is required:
                                       House centipede (Scutigera
                                        coleoptrata) OR Florida blue
                                        centipede (Hemiscolopendra
                                        marginata) OR Scolopendra sp.
------------------------------------------------------------------------

Sec.  158.1736  Lice.

    (a) General. The table in this section applies to human lice. The
product labeling claim determines the required test species. The
required test species for a labeling claim appears in paragraph (b) of
this section. The required performance standards appear in paragraph
(c) of this section.
    (b) Test species. For products making a claim against lice, the
required test species for a labeling claim appear in the following
table.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                           Claim Against Lice
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Lice..............................  Testing on one of the following
                                     species is required:
                                       Head louse (Pediculus humanus
                                        capitis) OR Body louse
                                        (Pediculus humanus humanus).
------------------------------------------------------------------------

    (c) Performance standards. For labeling claims against lice, a
performance standard of 100 percent is required.

Sec.  158.1740  Fleas.

    (a) General. The table in this section applies to fleas. The
product labeling claim determines the required test species. The
required test species for a labeling claim appears in paragraph (b) of
this section.
    (b) Test species. For products making a claim against fleas, the
required test species for a labeling claim is set forth in the
following table.

 Table 1 of 158.1740--Required Test Species for Products Making a Claim
                              Against Fleas
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Fleas.............................  Testing on the following species is
                                     required:
------------------------------------------------------------------------
                                    Cat flea (Ctenocephalides felis)
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Cat flea..........................  Cat flea (Ctenocephalides felis).
Chigoe flea.......................  Chigoe flea (Tunga penetrans).
Dog flea..........................  Dog Flea (Ctenocephalides canis).
Hen flea..........................  Hen flea (Ceratophyllus gallinae).
Human flea........................  Human flea (Pulex irritans).
Oriental rat flea.................  Oriental rat flea (Xenopsylla
                                     cheopis).
------------------------------------------------------------------------

Sec.  158.1744  Cockroaches.

    (a) General. The table in this section applies to cockroaches. The
product labeling claim determines the required test species. The
required test species for a labeling claim appears in paragraph (b) of
this section. Specific parameters that apply to individual tests and
labeling claims appear in paragraph (c) of this section.
    (b) Test species. For products making a claim against cockroaches,
the required test species for a labeling claim for cockroaches and the
test species for pest-specific label claims appear in the following
table.

 Table 1 of 158.1744--Required Test Species for Products Making a Claim
                           Against Cockroaches
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claims
------------------------------------------------------------------------
Cockroaches.......................  Testing on two species is required:
                                       American cockroach (Periplaneta
                                        americana) AND German cockroach
                                        (Blattella germanica).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
American cockroach................  American cockroach (Periplaneta
                                     americana).
Australian cockroach..............  Australian cockroach (Periplaneta
                                     australasiae).
Brown cockroach...................  Brown cockroach (Periplaneta
                                     brunnea).
Brownbanded cockroach.............  Brownbanded cockroach (Supella
                                     longipalpa).
German cockroach..................  German cockroach (Blattella
                                     germanica).
Oriental cockroach................  Oriental cockroach (Blatta
                                     orientalis).
Smokybrown cockroach..............  Smokybrown cockroach (Periplaneta
                                     fuliginosa).
Turkestan cockroach...............  Turkestan cockroach (Blatta
                                     lateralis).
------------------------------------------------------------------------

Sec.  158.1748  Keds, screwworms, and bot flies.

    (a) General. The table in this section applies to keds, screwworms,
and bot flies. The product labeling claim determines the required test
species. The required test species for labeling claims appear in
paragraph (b) of this section.
    (b) Test species. For products making a claim against keds,
screwworms, and bot flies, the required test species for a labeling
claim appear in the following table.

 Table 1 of 158.1748--Required Test Species for Products Making a Claim
                 Against Keds, Screwworms, and Bot Flies
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Bot Flies (excluding Human bot      Testing is required on one of the
 fly).                               following species:
                                       Horse bot fly (Gasterophilus
                                        intestinalis) OR Throat bot fly
                                        (Gasterophilus nasalis) OR Nose
                                        bot fly (Gasterophilus
                                        haemorrhoidalis).
Human bot fly.....................  Human bot fly (Dermatobia hominis).
Keds..............................  Testing is required on the following
                                     species:
                                       Sheep ked (Melophagus ovinus).
Screwworms........................  Testing is required on one of the
                                     following species:
                                       Screwworm (Cochliomyia
                                        hominivorax) OR Secondary
                                        screwworm (Cochliomyia
                                        macellaria).
------------------------------------------------------------------------

Sec.  158.1752  Filth flies.

    (a) General. The table in this section applies to filth flies. The
product labeling claim determines the required test species. The
required test species for a labeling claim against filth flies or
specific species of filth flies appear in paragraph (b) of this
section.

    (b) Test species. For products making a claim against filth flies,
the required test species for a labeling claim against filth flies
appear in the following tables.

 Table 1 of 158.1752--Required Test Species for Products Making a Claim
                           Against Filth Flies
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Filth Flies.......................  Testing on two species is required:
                                       House fly (Musca domestica).
                                       AND one of the following species
                                        is required:
                                       Flesh fly (Sarcophaga sp.,
                                        Wohlfahrtia sp., and other
                                        genera of flesh flies) OR Blow
                                        fly (Phaenicia sp., Calliphora
                                        sp., and other genera of blow
                                        flies).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Blow fly..........................  Blow fly (Phaenicia sp., Calliphora
                                     sp., and other genera of blow
                                     flies).
Cluster fly.......................  Cluster fly (Pollenia rudis).
Face fly..........................  Face fly (Musca autumnalis).
Flesh fly.........................  Flesh fly (Sarcophaga sp.,
                                     Wohlfahrtia sp., and other genera
                                     of flesh flies).
House fly.........................  House fly (Musca domestica).
Little house fly..................  Little house fly (Fannia
                                     canicularis).
------------------------------------------------------------------------

Sec.  158.1756  Mosquitoes.

    (a) General. The tables and test notes in this section apply to
mosquitoes. The required test species for a labeling claim against
mosquitoes appears in paragraph (b) of this section. For a claim
against any specific species of mosquito, that individual species and
all the required test genera must be tested. Claims against mosquitos
in association with mosquito-borne diseases are also subject to the
requirements in Sec.  158.1709.
    (b) Test species. For products making a claim against mosquitoes,
the required test species for a labeling claim is set forth in the
following table.

 Table 1 of 158.1756--Required Test Species for Products Making a Claim
                           Against Mosquitoes
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Mosquitoes........................  Testing in three genera (Culex,
                                     Aedes, and Anopheles) of mosquitoes
                                     is required.
                                       One of the following Culex
                                        species:
                                       Culex pipiens OR Culex
                                        quinquefasciatus OR Culex
                                        tarsalis
                                       AND one of the following Aedes
                                        species:
                                       Aedes aegypti OR Aedes albopictus
                                       AND one of the following
                                        Anopheles species:
                                       Anopheles albimanus OR Anopheles
                                        freeborni OR Anopheles gambiae
                                        OR Anopheles punctipennis OR
                                        Anopheles quadrimaculatus OR
                                        Anopheles stephensi.
------------------------------------------------------------------------

Sec.  158.1760  Biting flies.

    (a) General. The tables in this section apply to biting flies,
which includes biting midges and black flies. The product labeling
claim determines the required test species. The required test species
for biting fly labeling claims and the test species for pest-specific
labeling claims appear in paragraphs (b) of this section.
    (b) Test species. For products making a claim against biting flies,
the required test species for a labeling claim and the test species for
pest-specific label claims appear in the following table.

 Table 1 of 158.1760--Required Test Species for Products Making a Claim
                          Against Biting Flies
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Biting flies (excluding Sand        Testing is required on three
 flies).                             species:
                                    Stable fly (Stomoxys calcitrans).
                                    AND one of the large biting fly
                                     species:
                                       Black horse fly (Tabanus atratus)
                                        OR Deer fly (Chrysops sp.) OR
                                        Striped horse fly (Tabanus
                                        lineola).
                                       AND one of the small biting fly
                                        species:
                                       Biting midge (punkie, granny
                                        nipper, no-see-um) (any
                                        Culicoides sp.) OR Black fly
                                        (any Simulium sp. or Prosimulium
                                        sp.) OR Black gnat (any
                                        Leptoconops sp.).
------------------------------------------------------------------------
                          Pest Sub-Group Claims
------------------------------------------------------------------------
Large Biting Flies................  Testing is required on two species:
                                       Stable fly (Stomoxys calcitrans).
                                       AND one of the following species:
                                       Black horse fly (Tabanus atratus)
                                        OR Deer fly (Chrysops sp.) OR
                                        Striped horse fly (Tabanus
                                        lineola).

Small Biting Flies (excluding Sand  Testing is required on one of the
 flies).                             following species:
                                    Biting midge (punkie, granny nipper,
                                     no-see-um) (Culicoides sp.) OR
                                     Black fly (Simulium sp. OR
                                     Prosimulium sp.) OR Black gnat
                                     (Leptoconops sp.).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Biting midges (punkie, granny       Biting midge (punkie, granny nipper,
 nipper, no-see-um).                 no-see-um) (Culicoides sp.).
Black flies.......................  Testing on one of the following
                                     species is required:
                                       Simulium sp. OR Prosimulium sp.
Black gnats.......................  Black gnat (Leptoconops sp.).
Deer flies........................  Deer fly (Chrysops sp.).
Greenhead.........................  Greenhead (Tabanus nigrovittatus).
Horn fly..........................  Horn fly (Haematobia irritans).
Horse flies.......................  Testing on one of the following
                                     species is required:
                                       Black horse fly (Tabanus
                                        atratus), OR Striped horse fly
                                        (Tabanus lineola).
Sand flies........................  Testing on one of the following
                                     species is required:
                                       Lutzomyia sp. OR Phlebotomus sp.
Stable fly........................  Stable fly (Stomoxys calcitrans).
------------------------------------------------------------------------

Sec.  158.1768  Bed bugs.

    (a) General. The table in this section applies to bed bugs. The
product labeling claim determines the required test species. The
required test species for a labeling claim appears in paragraph (b) of
this section.
    (b) Test species. For products making a claim against bed bugs, the
required test species for a labeling claim appear in the following
table.

 Table 1 of 158.1768--Required Test Species for Products Making a Claim
                            Against Bed Bugs
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Bed bugs..........................  Common bed bug (Cimex lectularius).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Common bed bug....................  Common bed bug (Cimex lectularius).
Tropical bed bug..................  Tropical bed bug (Cimex hemipterus).
------------------------------------------------------------------------

Sec.  158.1772  Conenose bugs and kissing bugs.

    (a) General. The table in this section applies to Conenose bugs and
Kissing bugs. The product labeling claim determines the required test
species. The required test species for a labeling claim appears in
paragraph (b) of this section.
    (b) Test species. For products making a claim against either the
conenose and/or kissing bugs, the required test species for a labeling
claim is set forth in the following table.

 Table 1 of 158.1772--Required Test Species for Products Making a Claim
                        Conenose and Kissing Bugs
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Conenose bug......................  Conenose bug (Triatoma sanguisuga).
Kissing bug.......................  Kissing bug (Triatoma protracta).
------------------------------------------------------------------------

Sec.  158.1776  Ants (excluding carpenter ants).

    (a) General. The table in this section applies to ants (excluding
carpenter ants). The product labeling claim determines the required
test species. The required test species for labeling claims appear in
paragraph (b) of this section.
    Test species. For products making a claim against ants (excluding
carpenter ants), the required test species for a labeling claim appear
in the following table, unless otherwise specified in paragraphs (c) or
(d) of this section.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                           Claim Against Ants
                       [Excluding Carpenter Ants]
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Ants (excluding carpenter ants)...  Testing is required on the following
                                     two species:
                                    Pharaoh ant (Monomorium pharaonis)
                                     AND Red imported fire ant
                                     (Solenopsis invicta).
------------------------------------------------------------------------
                          XPest Sub-Group Claim
------------------------------------------------------------------------
Fire and Harvester................  Testing is required on the following
                                     species:
                                       Red imported fire ant (Solenopsis
                                        invicta).
Fire ants.........................  Testing is required on the following
                                     species:
                                       Red imported fire ant (Solenopsis
                                        invicta).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
European fire ant.................  European fire ant (Myrmica rubra).
Harvester ant.....................  Harvester ant (Pogonomyrmex sp.).
Pharaoh ant.......................  Pharaoh ant (Monomorium pharaonis).
Red imported fire ant.............  Red imported fire ant (Solenopsis
                                     invicta).
Southern fire ant.................  Southern fire ant (Solenopsis
                                     xyloni).
Tropical fire ant.................  Tropical fire ant (Solenopsis
                                     geminata).
Black imported fire ant...........  Black imported fire ant (Solenopsis
                                     richteri).
------------------------------------------------------------------------

    (c) Colony Claims. For colony claims, testing must be done specific
to the species listed. For colony claims against the red and/or black
imported fire ants, testing may be done on, S. invicta, S. richteri, or
their hybrid.
    (d) Bait products or claims involving outdoor use. The group and
sub-group claims in paragraph (b) of this section are for direct kill
and residual surface application claims against foraging ants only
(excluding colony claims). For bait products or claims involving
outdoor use, testing must be specific to the species listed.

Sec.  158.1780  Bees, wasps, yellowjackets, and hornets.

    (a) General. The table in this section applies to bees, wasps,
yellowjackets, and hornets. The labeling claim determines the required
test species. The required test species for labeling claims appear in
paragraph (b) of this section.
    (b) Test species. For products making a claim against bees, wasps,
yellowjackets, and hornets, the required test species for a labeling
claim appear in the following table, unless otherwise specified in
paragraph (c) of this section.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
          Claim Against Bees, Wasps, Yellowjackets, and Hornets
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claims
------------------------------------------------------------------------
Bees, Wasps, Yellowjackets, and     Testing on three species is
 Hornets.                            required:
                                    Two Yellowjacket species (one
                                     Vespula sp. AND the Bald-faced
                                     hornet (Dolichovespula maculata))
                                     AND one Paper wasp (Polistes sp.).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
Bald-faced hornet.................  Bald-faced hornet (Dolichovespula
                                     maculata).
Mud dauber wasp...................  Mud dauber wasp (Sphecidae sp.).
Paper wasp........................  Paper wasp (Polistes sp.).
Yellowjackets.....................  Yellowjacket (Vespula sp.).
------------------------------------------------------------------------

    (c) Colony claims. For colony claims, except Vespula spp., testing
must be specific to the species listed. Acceptable data for any Vespula
species may support a yellowjacket colony claim for ground nesting
Vespula species; however, species-specific claims need to be supported
by data from testing of the specific species. Colony claims against
Vespula spp. have a performance standard of 100%.

Sec.  158.1782  Carpenter ants.

    (a) General. The table in this section applies to carpenter ants.
The product labeling claim determines the required test species. The
required test species for labeling claims appear in paragraph (b) of
this section. The required performance standards appear in paragraph
(c) of this section.
    (b) Test species. For products making a claim against carpenter
ants, the required test species for a labeling claim appear in the
following table.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                      Claim Against Carpenter Ants
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
Carpenter ants....................  Testing on one of the following
                                     carpenter ant species is required:
                                       Black carpenter ant (Camponotus
                                        pennsylvanicus) OR Florida
                                        carpenter ant (Camponotus
                                        floridanus) OR Western carpenter
                                        ant (Camponotus modoc).
------------------------------------------------------------------------

    (c) Performance standards. The performance standards for pesticide
products making certain claims against carpenter ants appear in the
following table. The performance standards for labeling claims that are
not specifically provided in the following table appear in Sec.
158.1704.

   Table 2 to Paragraph (c)--Performance Standards for Certain Claims
                         Against Carpenter Ants
------------------------------------------------------------------------
       Application category                 Performance standard
------------------------------------------------------------------------
Bait Treatment....................  95% prevention of damage to wood for
                                     >=3 years.
Non-Structural: Wood Preservative   100% prevention of damage to wood
 Treatment.                          for >=2 years.
Structural Protection.............  95% prevention of damage to wood >=5
                                     years.
------------------------------------------------------------------------

Sec.  158.1784  Wood-destroying beetles.

    (a) General. The tables and test notes in this section apply to
wood-destroying beetles. The labeling claim determines the required
test species. The required test species for a labeling claim appears in
paragraph (b) of this section. The required performance standards
appear in paragraph (c) of this section.
    (b) Test species. For products making a claim against wood-
destroying beetles, the required test species for a labeling claim is
set forth in the following table.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                  Claim Against Wood-Destroying Beetles
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
True powderpost beetles...........  Testing on one species from the
                                     Lyctinae subfamily is required.
Wood-destroying or wood-boring      Testing on three species is
 beetles.                            required:
                                    Anobiid beetle (Anobiidae sp.) AND
                                     Bostrichid beetle (Bostrichidae
                                     sp.) AND Old house borer
                                     (Hylotrupes bajulus).
------------------------------------------------------------------------

    (c) Performance standards. The performance standards for pesticide
products making certain claims against wood-destroying beetles appear
in the following table. The performance standards for labeling claims
that are not specifically provided in the following table appear in
Sec.  158.1704.

   Table 2 to Paragraph (c)--Performance Standards for Certain Claims
                     Against Wood-Destroying Beetles
------------------------------------------------------------------------
       Application category                 Performance standard
------------------------------------------------------------------------
Bait Treatment....................  95% prevention of damage to wood >=3
                                     years.
Non-Structural: Wood Preservative   100% prevention of damage to wood
 Treatment.                          for >=2 years.
Structural Protection.............  95% prevention of damage to wood >=5
                                     years.
------------------------------------------------------------------------

Sec.  158.1786  Termites.

    (a) General. The tables and test notes in this section apply to the
subterranean termite, desert subterranean termite, Formosan
subterranean termite, drywood termite, and dampwood termite. The
labeling claim determines the required test species. The required test
species for labeling claims appear in paragraph (b) of this section.
The required performance standards appear in paragraph (c) of this
section.
    (b) Test species. For products making a claim against termites, the
required test species for a labeling claim appear in the following
table.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                         Claim Against Termites
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Termites..........................  Testing on species from four genera
                                     of termites is required:
                                    Testing is required on the following
                                     Coptotermes termite:
                                       Coptotermes formosanus
                                    AND one of the following
                                     Reticulitermes species:

                                       Reticulitermes flavipes OR
                                        Reticulitermes hesperus OR
                                        Reticulitermes virginicus
                                    AND one of the following arboreal
                                     termite species:
                                       Nasutitermes coringer
                                        (Motschulsky)
                                    AND one of the following drywood
                                     termite species:
                                       Cryptotermes brevis OR
                                        Cryptotermes cavifrons OR
                                        Incisitermes minor OR
                                        Incisitermes snyderi.
------------------------------------------------------------------------
                          Pest Sub-Group Claim
------------------------------------------------------------------------
Arboreal Termites.................  Testing of one arboreal termite
                                     species is required:
                                       Nasutitermes coringer
                                        (Motschulsky).
Dampwood Termites.................  Testing of the following dampwood
                                     termite is required:
                                       Zootermopsis sp.
Drywood Termites..................  Testing of one of the following
                                     drywood termites is required:
                                       Cryptotermes brevis OR
                                        Cryptotermes cavifrons OR
                                        Incisitermes minor OR
                                        Incisitermes snyderi.
Subterranean Termites, including    Testing in two genera of termites is
 Formosan Subterranean Termites.     required:
                                    Testing on the following Coptotermes
                                     species is required:
                                       Coptotermes formosanus
                                    AND one of the following
                                     Reticulitermes species:
                                       Reticulitermes flavipes OR
                                        Reticulitermes hesperus OR
                                        Reticulitermes virginicus.
------------------------------------------------------------------------

    (c) Performance standards. The performance standards for pesticide
products making certain claims against termites appear in the following
table. The performance standards for labeling claims not provided in
the following table appear in Sec.  158.1704.

   Table 2 to Paragraph (c)--Performance Standards for Certain Claims
                            Against Termites
------------------------------------------------------------------------
       Application category                 Performance standard
------------------------------------------------------------------------
Bait Treatment....................  95% prevention of damage to wood >=3
                                     years.
Non-Structural: Wood Preservative   100% Prevention of damage to wood
 Treatment.                          for >=2 years.
Structural Protection.............  95% prevention of damage to wood >=5
                                     years.
------------------------------------------------------------------------

0
5. Revise Sec.  158.2070 to read as follows:

Sec.  158.2070  Biochemical pesticides product performance data
requirements.

    (a) General. Product performance data must be developed for all
biochemical pesticides. Each applicant must ensure through testing that
the 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.
    (b) Product performance data for each product that bears a claim
against an invertebrate pest that is covered by subpart R of this part.
The product performance data requirements of subpart R of this part
apply to biochemical products covered by this subpart. Product
performance data must be submitted with any application for
registration or amended registration. The performance standards
required in subpart R of this part also apply to biochemical pesticide
products. However, data requirements and the performance standards that
determine the acceptability of data may be modified on a case-by-case
basis pursuant to the waiver provisions in 40 CFR 158.45 and the
provisions in 40 CFR 158.1707.
    (c) Product performance data for each product that bears a public
health claim, excluding those covered under paragraph (b). Product
performance data must be submitted with any application for
registration or amended registration, if the product bears a claim to
control public health pests, such as pest microorganisms infectious to
humans in any area of the inanimate environment, or a claim to control
vertebrates, including but not limited to, rodents, birds, bats,
canids, and skunks.
0
6. Revise Sec.  158.2160 to read as follows:

Sec.  158.2160  Microbial pesticides product performance data
requirements.

    (a) General. Product performance data must be developed for all
microbial pesticides. Each applicant must ensure through testing that
the 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.
    (b) Product performance data for each product that bears a claim
against an invertebrate pest that is covered by subpart R of this part.
The product performance data requirements of subpart R of this part
apply to microbial products covered by this subpart. Product
performance data must be submitted with any application for
registration or amended registration. However, data requirements and
the performance standards that determine the acceptability of data may
be modified on a case-by-case basis pursuant to the waiver provisions
in 40 CFR 158.45 and the provisions in 40 CFR 158.1707.
    (c) Product performance data for each product that bears a public
health claim, excluding those covered under paragraph (b). Product
performance data must be submitted with any application for
registration or amended registration, if the product bears a claim to
control public health pests, such as

pest microorganisms infectious to humans in any area of the inanimate
environment, or a claim to control vertebrates, including but not
limited to, rodents, birds, bats, canids, and skunks.
0
7. In Sec.  158.2200, revise paragraph (b) to read as follows:

Sec.  158.2200  Applicability.

* * * * *
    (b) A product that bears both antimicrobial and non-antimicrobial
uses or claims is subject to the data requirements for pesticides in
subparts C through O, R, 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.
* * * * *
[FR Doc. 2021-05137 Filed 3-19-21; 8:45 am]
BILLING CODE 6560-50-P