[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Proposed Rules]
[Pages 15362-15396]
[FR Doc No: 2021-05137]

Vol. 86

Monday,

No. 53

March 22, 2021

Part III

Environmental Protection Agency

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40 CFR Part 158

Pesticide Product Performance Data Requirements for Products Claiming
Efficacy Against Certain Invertebrate Pests; Proposed Rule

Federal Register / Vol. 86 , No. 53 / Monday, March 22, 2021 /
Proposed Rules

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2020-0124; FRL-10011-06]
RIN 2070-AJ49

Pesticide Product Performance Data Requirements for Products
Claiming Efficacy Against Certain Invertebrate Pests

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
codify product performance data requirements to support registration of
pesticidal products claiming efficacy against three categories of
invertebrate pests: Those identified to be of significant public health
importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-
destroying insects (e.g., termites), and certain invasive invertebrate
species (e.g., Asian longhorned beetle). The latter two categories are
pests considered to be of significant economic or ecological
importance. Product performance data (efficacy studies) document how
well the pesticide performs the intended function, such as killing or
repelling, against an invertebrate pest.

DATES: Comments must be received on or before May 21, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2020-0124, through the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. To make special
arrangements for hand delivery or delivery of boxed information, please
follow the instructions at http://www.epa.gov/dockets/contacts.html.
    Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room was closed to public visitors on March
31, 2020. Our EPA/DC staff will continue to provide customer service
via email, phone, and webform. For further information on EPA/DC
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sara Kemme, Mission Support Division
(7101M), Office of Program Support, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(703) 347-8533; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You potentially may be affected by this action if you are a
producer or registrant of pesticide products making claims against the
specified categories of invertebrate pests. The North American
Industrial Classification System (NAICS) codes are provided to assist
you and others in determining if this action might apply to certain
entities. This listing is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be regulated
by this action. Other types of entities not listed could also be
affected. Potentially affected entities may include, but are not
limited to,
     Chemical Producers (NAICS 32532), e.g., pesticide
manufacturers or formulators of pesticide products, pesticide importers
or any person or company who seeks to register a pesticide.
     Research and Development in the Physical, Engineering, and
Life Sciences (NAICS code 541712), e.g., research and development
laboratories or services that perform efficacy testing for invertebrate
pests.
     Colleges, universities, and professional schools (NAICS
code 611310), e.g., establishments of higher learning which are engaged
in development and marketing of products for invertebrate pest control.

B. What action is the Agency taking?

    EPA is proposing to codify product performance data requirements
for pesticide products claiming efficacy against three categories of
invertebrate pests: Those identified to be of significant public health
importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-
destroying insects (e.g., termites), and certain invasive invertebrate
species (e.g., Asian longhorned beetle). The latter two categories are
considered to be of significant economic and/or ecological importance.
    Product performance data (efficacy studies) document how well the
product performs the intended function, such as killing or repelling,
against an invertebrate pest. The product performance data requirements
being proposed would inform the data needed to substantiate pesticidal
claim(s) made on the label of the pesticide products. The proposed
numerical performance standards specify the level of efficacy that
would need to be achieved for EPA to deem the submitted data as
acceptable for a product bearing the specified claim(s) against the
invertebrate pest. For the most part, the data requirements that EPA is
proposing for codification are consistent with EPA's current practices
in data supporting applications for registration of a pesticide product
that bears a pesticidal claim against one or more of these pests.
    This proposed rule presents the data requirements in tabular
format. These tables link the efficacy claim on the label of a
pesticide product with the data needed to substantiate that claim. EPA
is proposing that the studies submitted by an applicant demonstrate the
product's efficacy in studies using specified test species and with
results demonstrating that the product achieved a specified level of
performance, called a performance standard. Numerical performance
standards, such as the percent mortality, percent repellency, percent
knockdown, or complete protection time would need to be achieved to
deem the data acceptable for the purpose of supporting a product making
a claim against an invertebrate pest. The Agency believes that
codifying essential elements relating to test species and performance
standards will provide the regulated community a better understanding
of the data EPA believes to be necessary to support registration of a
product that claims efficacy against invertebrate pests.
    EPA is proposing to:
     Codify a new subpart R in 40 CFR part 158 entitled,
``Product Performance for Products Claiming Effectiveness Against
Invertebrate Pests;''
     Rename 40 CFR part 158, subpart E to ``Product Performance
for Products Claiming Effectiveness Against Vertebrate Pests, Products
with Prion-related Claims, and Products for Control of Organisms
Producing Mycotoxins'' in order to add specificity to the title and
reduce the potential for confusion with the proposed subpart R; and
     Revise the data requirements for biochemicals in 40 CFR
158.2070 and microbials in 40 CFR 158.2160 to clarify the requirements
for claims that would be subject to both subpart R and either subpart U
or V.
    Additionally, EPA proposes to update 40 CFR 158.1(c) to insert
references to the subparts to categorize them under the ``scope of the
subparts'' section. EPA is also proposing to update subpart W at 40 CFR
158.2200(b) to insert a cross reference to the proposed subpart R to
clarify the status of a product that bears

both an antimicrobial claim and a non-antimicrobial claim against one
of the pests specified in proposed subpart R.

C. What is EPA's authority for taking this action?

    This action is issued under the authority of sections 3, 5, 10, 12,
and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7 U.S.C. 136-136y), as amended. Under FIFRA section
3(c)(2)(A), EPA is required to specify ``the kinds of information which
will be required to support the registration of a pesticide and shall
revise such guidelines from time to time.'' EPA's codification of these
data requirements is in 40 CFR part 158.
    Additionally, the Pesticide Registration Improvement Extension Act
of 2018 (PRIA 4) (7 U.S.C. 136 note, 133 Stat. 484) was enacted into
law on March 8, 2019. PRIA was developed by a coalition of pesticide
stakeholders representing seven different trade groups within the
pesticide industry and public interest groups reflecting the
environmental and farmworker safety communities. The result of this
collaboration is that there are elements of PRIA 4 important to all the
represented stakeholder entities in the coalition. PRIA 4 specifically
establishes a new maintenance fee set-aside of up to $500,000/year to
develop and finalize rulemaking and guidance for product performance
data requirements for certain invertebrate pests of significant public
health or economic importance. Specific to this rule, PRIA 4 requires
EPA to finalize product performance data requirements by September 30,
2021. Specifically, the Act states that, ``The Administrator shall, not
later than September 30, 2021, issue regulations prescribing product
performance data requirements for any pesticide intended for
preventing, destroying, repelling, or mitigating any invertebrate pest
of significant public health or economic importance specified in
clauses (i) through (iv) of paragraph (B) [bed bugs; premise (including
crawling insects, flying insects, and baits), pests of pets (including
pet pests controlled by spot-ons, collars, shampoos, powders, or dips),
and fire ants].''
    This proposed rule includes product performance data requirements
for the categories of invertebrate pests specified in PRIA 4 and, thus,
is intended to satisfy the aforementioned rulemaking requirement. EPA
notes that this proposed rule covers some invertebrate pests in
addition to those specified in PRIA 4 due to their public health,
economic, or ecological significance.

D. Why is EPA taking this action?

    The following objectives were considered by EPA in developing this
proposed rule:
    1. Obtaining reliable data to make the statutory finding. The data
submitted to EPA for review and evaluation as a result of this rule,
once final, are expected to improve the Agency's understanding of the
effectiveness of pesticides that make claims against pests of public
health or significant economic importance.
    2. Provide clear and transparent data requirements. Once final, the
regulatory text proposed in this rule is intended to identify the
specific data requirements that apply to pesticides making claims
against certain categories of invertebrate pests. As with the original
design of part 158 in 1984, and continued in 2007, given the variations
in pesticide chemistry, exposure, and hazard, this proposal for product
performance data requirements is intended to be clear and transparent
while retaining sufficient flexibility to account for special
circumstances.

E. What are the estimated incremental impacts?

    In conjunction with this proposed rulemaking, EPA prepared an
economic analysis entitled, ``Cost Analysis of the Proposed Product
Performance Rule'' (Ref. 1) which presents an analysis of the effects
of codifying data requirements for product performance, as well as the
effects of changes to label claim data requirements published
simultaneously.
    As noted previously, FIFRA mandates the Agency to register
pesticides, including those used against invertebrate pests of public
health importance, invertebrate wood destroying pests, and invasive
invertebrate pests, under conditions of use such that the pesticide is
of a composition to warrant the proposed claims. To make this finding,
the Agency requires that registrants submit data demonstrating product
efficacy against invertebrate pests of public health importance,
invertebrate wood destroying pests, and invasive invertebrate pests.
The product performance data requirements historically sought by the
EPA and those being proposed in the rule are for claims against pests
that either pose a threat to human health (e.g., mosquitoes and
cockroaches) or have significant economic impacts, against which the
efficacy of a pesticide cannot be readily determined by the user (e.g.,
termites and emerald ash borers). In those situations, market forces
may operate too slowly to remove ineffective products. The proposal,
once final, would codify data requirements for support of label claims
that have, to date, been necessary, as determined on a case-by-case
basis, to conduct assessments of product performance. This will provide
needed clarity to firms seeking to develop and market products to
control invertebrate pests of public health importance, invertebrate
wood destroying pests, and invertebrate invasive pests.
    This rule, when finalized, will clarify data requirements and
therefore improve efficiency and effective use of resources by both the
Agency and industry. Moreover, this rule-making measure will serve the
public by ensuring that appropriate efficacy data are available to
substantiate public health pest claims. While experience over time has
led to a fairly standardized set of data requirements for invertebrate
pests of significant public health importance, wood-destroying insects,
and invasive pests, codifying these data needs will ensure that new
entrants to the field are clear about the information necessary to
support registration. As a result, this rule, when finalized, would
help alleviate uncertainties in the regulatory process and enhance
transparency for stakeholders. The Agency is specifying data
requirements for invertebrate pests of significant public health
importance, wood-destroying insects, and invasive invertebrate pests to
better indicate when certain data are needed or not. Consistent with 40
CFR 158.45 and proposed 40 CFR 158.1707, on a case-by-case basis the
Agency may consider alternative data that are more appropriate than the
proposed requirements considering the intended purpose and pesticidal
claims of a pesticidal product.
    EPA estimates that the proposed rule would result in cost savings
of one million dollars annually across all registrants seeking label
claims against invertebrate pests of significant public health
importance, wood-destroying insects, and invasive invertebrate pests,
equivalent to about $17,000 in savings per data package submitted to
the Agency (Table 1). The average savings per registrant is $5,500
annually, considering that registrants do not submit products for
review every year. This impact is expected to remain consistent over
the next ten years, with total cost savings to industry of $1 million
annually using either a 3% or a 7% discount rate. Over ten years, this
amounts to about $8.5 million in savings at a 3% discount rate or about
$7 million in savings at a 7% discount

rate. The most expansive estimate of registrant cost savings of the
proposed rule, including all likely impacts of the publication of the
rule and the impact of changes in data requirements published
concurrently with the rule, is $1.7 million annually. The estimated
worst case is a cost increase to registrants of $600,000 annually.
    EPA's registration program and efficacy review has substantial
benefits for consumers. It ensures product efficacy and label
consistency across products, increases consumer confidence in product
efficacy, and reduces consumer search costs for effective products.
This may help reduce the incidence of vector-borne diseases and damage
from wood-destroying and invasive pests. Clarity in data requirements
would enhance the efficiency of the registration process and aid new
products to market, providing consumers with more product choices.

            Table 1--Benefits and Costs of the Proposed Rule
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                 Expected Benefits of the Proposed Rule
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Cost savings per data package   Average impact per submitted
 submitted.                     data package of $17,000.
Cost savings per registrant     Average annual impact per
 submitting data packages.      registrant of $5,500.
Annualized Cost Savings......   $1 million at both 3% and 7%
                                discount rates.
                                This projection assumes 60 data
                                packages submitted annually to the
                                Agency.
Qualitative Effects..........   For registrants: Quicker label
                                changes, lower discovery costs, lower
                                barriers to innovation.
                                For consumers: Ensuring product
                                efficacy and label consistency;
                                increased consumer confidence in product
                                efficacy; reduced search costs for
                                effective products; and reduction in
                                damage from covered pests.
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                   Expected Costs of the Proposed Rule
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No increased risk to human health or the environment is expected from
 publication of the proposed rule. No increased costs to registrants or
 consumers are expected from publication of the proposed rule. Expected
 direction of costs for the Agency from the proposed rule are unknown.
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                              Other Impacts
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Small Business Impacts.......   No significant impact on a
                                substantial number of small entities
                                Affected NAICS codes contain up
                                to 5,438 small entities. No increased
                                costs to small entities expected, and
                                cost savings may be relatively larger
                                for small firms who do not have
                                experience with the registration process
                                for invertebrate pests of public health
                                importance, invertebrate wood destroying
                                pests, and invertebrate invasive pests.
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F. What should I consider as I prepare my comments for EPA?

    1. Submitting Confidential Business Information (CBI). Do not
submit this information to EPA through regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Statutory Framework

    As a general matter, no person may distribute or sell an
unregistered pesticide in the U.S. (FIFRA section 3(a)). The process
for obtaining a registration for a pesticide so that it may be
distributed or sold begins with submission to EPA of an application
with the necessary data to review the application request. Taking into
account the information submitted, EPA must grant the requested
registration, if it concludes, when considered with any restrictions
imposed, that:
     Composition of the proposed pesticide is such as to
warrant the proposed claims for it;
     Labeling for the proposed pesticide and other material
required to be submitted comply with the requirements of FIFRA;
     The proposed pesticide will perform its intended function
without unreasonable adverse effects on the environment; and
     When used in accordance with widespread and commonly
recognized practice, the proposed pesticide will not generally cause
unreasonable adverse effects on the environment.
    FIFRA section 3(c)(5) further provides that EPA ``may waive data
requirements pertaining to efficacy, in which event the Administrator
may register the pesticide without determining that the pesticide's
composition is such as to warrant proposed claims of efficacy.'' The
proposed regulations identify the data requirements EPA believes are
necessary to determine whether the proposed claims of efficacy are
warranted, the opportunity for waiver is covered by 40 CFR 158.45 and
proposed 40 CFR 158.1707.
    EPA notes that ``unreasonable adverse effects on the environment''
means ``any unreasonable risk to man or the environment, taking into
account the economic, social, and environmental costs, and benefits of
the use of any pesticide . . .'' as described in FIFRA section 2(bb).
That definition was amended in 1998 as part of the Food Quality
Protection Act, requiring EPA to consider ``the risks and benefits of
public health pesticide separate from the risks and benefits of other
pesticides. In weighing any regulatory action concerning a public
health pesticide under this Act, the administrator shall weigh any
risks of the pesticide against the health risks such as the disease
transmitted by the vector to be controlled by the pesticide.'' While
this rule proposes to codify product performance data requirements for
invertebrate pests of

significant public health importance, (Ref. 2) this rule does not
address classification of pesticides as ``public health pesticides'' as
that term is defined in FIFRA section 3(nn). The data requirements
proposed in this rule will be used to make appropriate determinations
under the FIFRA ``unreasonable adverse effects'' standard.
    To determine whether the proposed use of the pesticide will not
cause unreasonable adverse effects, EPA generally considers the maximum
proposed use of a new pesticide to estimate the maximum exposure
potential, evaluates the hazard data on the pesticide, and compares the
rates at which effects are found based on well conducted studies with
the maximum exposure estimate. However, for pesticides intended for use
against pests of public health or economic importance, EPA has for some
time considered whether the pesticide may cause human health,
environmental or economic harm if its use as proposed will not work as
intended or claimed. Data on the pesticide's performance under the
conditions of use proposed are essential to make this determination.

A. Registration

    Section 3 of FIFRA contains the requirements for granting and
maintaining registration. FIFRA section 3(c)(2) provides EPA broad
authority, before and after registration, to require scientific testing
and submission of the resulting data to the Agency. Under this
authority, EPA requires such testing and submission of data through
rulemaking, see, 40 CFR part 158 or, for existing registrations,
through issuance of a ``data call-in.'' (See, FIFRA section
3(c)(2)(B)). EPA may also request further data if the data submitted
fail to adequately address an issue necessary for making the requisite
statutory findings. (See, 40 CFR 158.75). Consistent with the
requirements EPA has imposed and the data that have been identified as
needed to review applications for registration of pesticides of
significant health or economic importance, an applicant for
registration must furnish EPA with data on the pesticide, its
composition, toxicity, potential human exposure, environmental
properties and ecological effects, as well as its product performance
(efficacy).

B. Registration Review

    FIFRA section 3(g) mandates that the registrations of all
pesticides are to be periodically reviewed. Periodic review is needed
as changes in science, public policy, and pesticide use practices occur
over time. The registration review program was implemented via a
regulation promulgated on August 9, 2006 (71 FR 45719) (FRL-8080-4).
Therefore, starting in 2006, registration review began to replace EPA's
reregistration program as the mechanism for systematic review of
existing pesticides. The registration review process begins by
reviewing the available information in the possession of the Agency and
then determining if and what data are needed to assess the current
risks of a particular pesticide. Thus, as with registration, the data
needed and the scope and depth of the Agency's review for registration
review continue to be tailored to the specific circumstances and use of
the registered pesticide. Section 3(g)(2)(A) of FIFRA authorizes EPA to
require generation and submission of additional data necessary for
registration review pursuant to its authority under FIFRA section
3(c)(2)(B).

III. Regulatory Framework

    The existing regulatory data requirements for product performance
for pesticides are contained in 40 CFR part 158, subpart E, and for the
most part the table in 40 CFR 158.400(d) is specific to vertebrates
(e.g., birds, rodents, etc.); 40 CFR part 158 subpart W also contains
pesticide data requirements for antimicrobials. However, subpart E does
not specifically require submission of product performance data for
those pesticide products claiming effectiveness against invertebrate
pests (e.g., insects, spiders, etc.). Instead, the test note in 40 CFR
158.400(e)(1) contemplates requiring the submission of product
performance data on a case-by-case basis, consistent with the general
authority in 40 CFR 158.75 to require additional data as part of the
registration process, if the information that is required and submitted
for registration is not sufficient to make the requisite statutory
findings. EPA has relied on these authorities for some years to obtain
needed product performance data for conventional pesticides intended
for use against certain invertebrate pests of public health or economic
significance.
    Although the updating of 40 CFR part 158 regulations began years
ago, EPA made no changes to the product performance data requirements
at 40 CFR part 158, subpart E, as they relate to the invertebrate pests
covered in this action. (72 FR 60934, October 26, 2007) (FRL-8106-5).
However, EPA did make some changes to the data requirements for
biochemical and microbial pesticides by codifying product performance
data requirements for biochemical and microbial pesticides in 40 CFR
158.2070 and 158.2160, subparts U and V, respectively (72 FR 60934,
October 26, 2007) (FRL-8106-5). That final rule adopted the requirement
for applicants to submit product performance data to support
registration of biochemical and microbial products claiming
effectiveness against invertebrate species.
    This rulemaking proposes to create a new subpart R for invertebrate
product performance requirements to capture the updates to the product
performance data requirements for pesticides, and to make conforming
edits to subparts E, U, V, and W.

IV. Background

    Since the early years of the registration program, EPA has waived
the need for product performance data for many pesticides, consistent
with the congressional authority in FIFRA section 3(c)(5), to waive
such data and to not make the finding that a proposed pesticide's
``composition is such as to warrant the proposed claims for it.'' (44
FR 27932, May 11, 1979) (FRL-2767-8). However, EPA did not codify its
early intent not to waive product performance data for pesticides
intended for use against certain invertebrate pests. Specifically, in
May of 1979, EPA initially announced the need for product performance
data for ``[i]nvertebrate control products intended for use in or on
humans (or in or on pets for control of pests which attack humans) to
control pests such as fleas, mites, lice, ticks, biting flies, and
mosquitoes'' and for``[i]nvertebrate control products intended for use
either in premises or in the environment to control pests of sanitary
or public health significance such as mosquitoes, biting flies, ticks,
fleas, houseflies, cockroaches, fire ants, hornets, wasps, poisonous
spiders, scorpions, centipedes, and bedbugs.'' (44 FR 27932, May 11,
1979) (FRL-2767-8). In contrast, in other subsequent rulemaking
actions, EPA announced its intent to require product performance data
only for products ``where lack of control would clearly result in
adverse health effects'' (47 FR 40659, September 15, 1982) (FRL-2138-1)
or where ``control cannot reasonably be observed by the user . . .''
(47 FR 40659, 40661) because other pests were more of an aesthetic and
nuisance problem rather than one of public health.
    Ultimately, EPA's final part 158 rule announced that EPA had
``decided to rescind the proposed efficacy data waiver with respect to
vertebrate control agents intended for control of pests that

directly or indirectly transmit disease to humans'' and included a test
note indicating that EPA waived product performance data ``unless the
pesticide product bears a claim to control pest microorganisms that
pose a threat to human health and whose presence cannot readily be
observed by the user including, but not limited to, microorganisms
infectious to man in any area of the inanimate environment, or a claim
to control vertebrates (such as rodents, birds, bats, canids, and
skunks) that may directly or indirectly transmit diseases to humans.
However, each registrant must ensure through testing that his/her
product is efficacious when used in accordance with label directions
and commonly accepted pest control practices. The Agency reserves the
right to require, on a case-by-case basis, submission of product
performance data for any pesticide product registered or proposed for
registration.'' (49 FR 42856, 42875, October 24, 1984) (FRL-2591-5); 40
CFR 158.400(e)(1). That provision remains largely unchanged today,
although in the subsequent updates to the data requirements for
microbial and biochemical pesticides, EPA made clear that the
submission of efficacy data would be required if ``the pesticide
product bears a claim to control . . . invertebrates (including but not
limited to: mosquitoes and ticks) that may directly or indirectly
transmit diseases to humans.'' (40 CFR 158.2160). Thus, existing EPA
regulations for conventional pesticides continue to presume the waiver
of product performance data for invertebrate pests unless EPA exercises
its discretion to require on a case-by-case basis submission of the
data to support claims against pests, including pests of significant
public health importance.
    In 2002, EPA issued Pesticide Registration Notice (PRN) 2002-1 in
compliance with the requirement in FIFRA section 28(d) to coordinate
with United States Department of Health and Human Services (HHS) and
United States Department of Agriculture (USDA) in identifying pests of
significant public health importance. The list of pests identified in
that PRN was ``derived in large part from review of the pesticide/pest
combinations for which efficacy (product performance) data are
generally required to be submitted and reviewed prior to
registration.'' (Ref. 2). EPA is the process of updating this document
and has recently made an updated draft available for public comment
(Ref. 2).

A. Why does product performance matter?

    The primary goal of this proposal is to assure that pesticide
products claiming effectiveness against an invertebrate pest of
significant public health or economic importance perform effectively.
This action addresses both health concerns and economic consequences
stemming from pesticide products that might not perform as claimed on
the label. EPA acknowledges that use of the term arthropod would
include all the pests identified in this document. However, product
performance data for additional invertebrate species, such as (but not
limited to) gastropods (snails and slugs) that serve as intermediate
parasite hosts or invasive mussels of ecological concern could be
needed in the future. To account for the potential for future data
needs, EPA will use the terms invertebrates or invertebrate pests in
reference to pests in all three categories (pests of significant public
health importance, invasive species, and wood-destroying insects).
    Consistent with the regulatory text in 40 CFR 158.400(e)(1) and as
noted in PRN 2002-1 and PRN 96-7: Termiticide Labeling, (Ref. 3). EPA
has regularly exercised its discretion to require submission of product
performance data for pesticides intended for use against invertebrate
pests of significant public health importance and of product
performance data on pesticides intended for use against invertebrate
pests of significant economic importance. Since 1984, particularly for
insect repellents, the awareness of the incidence and severity of
mosquito- and tick-borne diseases in the U.S. has changed. Mosquitoes
and ticks are not merely nuisance pests: The Centers for Disease
Control and Prevention (CDC) has determined that a single bite can
transmit sufficient infectious material, i.e., a sufficient amount of
pathogen, to cause serious, and sometimes fatal, disease. (Ref. 4).
This is true for both mosquito-borne diseases such as West Nile Virus,
St. Louis Encephalitis, and the Zika virus, and tick-borne diseases
such as Lyme Disease. (Refs. 5 and 6).
    If a person can become ill because of a single insect bite, a
person using an ineffective insect repellent may not have the
opportunity to realize that the insect repellent did not work as
expected and then correct the situation by purchasing another product.
Given the nature of these and other mosquito- and tick-borne diseases,
an ineffective insect repellent can have serious and sometimes fatal
consequences to a person's health.
    Consequences can also include both health and economic impacts. For
example, the common bed bug (Cimex lectularius) has long been a pest,
feeding on blood, causing itchy bites and generally irritating their
human hosts. EPA, CDC, and the USDA all consider bed bugs a pest of
significant public health importance. Bed bugs can cause a variety of
negative physical health, mental health, and economic consequences.
Effects can include:
     Allergic reactions to the bed bug bites, which can range
from no reaction to a small bite mark to, in rare cases, anaphylaxis
(severe, whole-body reaction).
     Secondary infections of the skin, such as impetigo,
ecthyma, and lymphangitis.
     Mental health impacts on people living in infested homes.
Reported effects include anxiety, insomnia and systemic reactions.
(Refs. 7 and 8).
    Bed bug infestations are also an economic burden on society. The
economic losses from health care, lost wages, lost revenue and reduced
productivity can be substantial. The cost of effectively eliminating
bed bugs may be significantly more than the cost of eliminating other
pests because bed bug control usually requires multiple visits by a
licensed pest control operator and diligence on the part of those who
are experiencing the infestation. Control in multi-family homes is much
more difficult than in single family homes because bed bugs frequently
travel between units, either by direct transport by humans or through
voids in the walls. Thus, there are additional costs and complexities
associated with coordinating and encouraging participation from
multiple residents. Also, if the pesticide product claiming to treat
bed bugs is not effective and families are forced into repeated (and
expensive) cycles of re-treatment, then serious health and economic
impacts can occur.
    While wood-destroying insects/structural pests are not pests of
significant public health importance, they are similar in that the
consequences of ineffective treatments can be severe. Unfortunately,
the effectiveness of a treatment to protect a wooden structure is not
readily apparent to the applicator at the time of application or during
the occupancy of the building or home. It is only after the damage
becomes apparent that the extent of needed repairs is determined. There
is a potential for significant financial loss to the property owner.
Thus, demonstrating the efficacy of pesticides intended to control
structural pests has a unique importance. Data on

the level of economic damage caused by structural pests on an annual
basis are difficult to obtain but several authors have attempted to
quantify it. The economic costs of termite property damage,
preventative treatments, and structural repairs can be quite severe,
with estimated cost at approximately $5 billion annually. (Refs. 9 and
10). While these estimates are indicative of the cost nationwide, the
costs borne by an individual property owner can be significant in their
own right, up to and including, loss of the structure.

B. Labels

    1. Label requirements. Pesticide product labeling provides
information to users on, among other things, the product's intended
uses, and how to handle and apply the produEPA's labeling regulations
are contained in 40 CFR part 156. EPA reviews pesticide labels to
determine whether the labeling is consistent with EPA's regulations,
and is accurate, clear and enforceable. The accuracy of the information
on the labeling is of particular importance for products making a claim
to kill or repel pests of significant public health importance and
wood-destroying pests. Such pests, if uncontrolled, can transmit
disease pathogens, thus posing a widely recognized and significant risk
to human health, and can result in significant economic impacts.
    Consumers purchase products that claim effectiveness against a pest
of significant public health importance precisely to avoid the harm
these pests can cause. Consumers have a reasonable expectation that the
claims on the pesticide label have a scientific basis, i.e., are based
on valid evidence, and are neither false nor misleading. Such claims
should be expressed using wording or graphics that are easily
understood and require little or no interpretation by the consumer. To
ensure that labeling provides consumers with accurate information
concerning how long and how well the product works, EPA reviews and
evaluates product performance (efficacy) data. Once the data have been
reviewed and evaluated, then the Agency works to ensure that the
labeling use directions and labeling claims are clear and consistent
with the results of the supporting product performance data.
    EPA believes that having reliable information concerning the
effectiveness of pesticide products that claim effectiveness against
invertebrate pests results in sound regulatory decisions and accurate
information on the labeling. Accurate labeling claims provide consumers
with information they need concerning the effectiveness of the
pesticide.
    2. Label Review Manual. Consistently, the Agency has in the Label
Review Manual explained the historical need for product performance
data for products intended for invertebrate control. The Label Review
Manual has for some time summarized the Agency's current practice of
requiring product performance data to support claims for pesticides
intended for use in or on humans (or in or on pets for control of pests
which attack humans such as fleas, ticks, mosquitoes, and biting flies)
and in premises or in the environment to control pests of sanitary or
significant public health importance such as termites, wasps,
scorpions, poisonous spiders, fire ants, cockroaches, centipedes, and
bedbugs. (Ref. 11).

C. EPA's Harmonized Test Guidelines for Invertebrate Product
Performance

    1. Existing Guidelines. EPA has established a unified library for
test guidelines issued by the Office of Chemical Safety and Pollution
Prevention (OCSPP) for use in testing chemical substances to develop
data for submission to EPA under the Toxic Substances Control Act
(TSCA) and FIFRA. This library of test guidelines represents an Agency
effort that began in 1991 to harmonize the test guidelines within
OCSPP, as well as to harmonize the OCSPP test guidelines with those of
the Organization for Economic Cooperation and Development, which
includes representation of countries, including the U.S., throughout
the world. The process for developing and amending the test guidelines
includes several opportunities for public participation and extensive
involvement of the scientific community, including peer review by the
FIFRA Scientific Advisory Panel (SAP), the Science Advisory Board
(SAB), and other expert scientific organizations. New or revised
guidelines are typically presented to SAP for peer review. The purpose
for harmonizing these guidelines into a single set of OCSPP guidelines
is to standardize testing procedures that should be performed to meet
the Agency's data requirements under FIFRA and TSCA. EPA's Invertebrate
Control Agents, Product Performance Guidelines are listed in Table 2.
    The guidelines themselves do not impose requirements. Instead, they
provide recognized methods for conducting acceptable tests, guidance on
reporting data, and definitions of terms. Since these are guidance,
pesticide registrants are not required to use these guidelines to
fulfill data requirements. Applicants may instead seek to fulfill the
data requirements by other appropriate means or by using a non-
guideline protocol. The applicant may submit a protocol of his own
devising for the Agency to review. EPA notes that there is a PRIA fee
category for submitting a protocol for EPA to review.
    The guidelines identify thresholds for determining whether a
product is effective. Since these thresholds are in guidance (not
codified requirements), they are considered recommendations and not
mandatory. EPA also acknowledges that the older (1998) guidelines, in
particular, generally lack adequate, up-to-date guidance on efficacy
data development, test protocols, and representative test species.
    EPA notes that the Product Performance Guideline 810.1000 entitled,
``Overview, Definitions, and General Considerations,'' discusses that
product performance data are needed for any product that ``bears a
claim to control pests that may pose a threat to human health.'' This
is specifically stated to include:
    Public health uses of invertebrate control agents including, but
not limited to, agents intended to control the following: Mosquitoes,
biting flies, ticks, fleas, houseflies, cockroaches, fire ants,
hornets, wasps, poisonous spiders, scorpions, biting midges,
centipedes, bedbugs, human lice, and dust mites. (Ref. 12).

Table 2--EPA's Series 810, Group C--Invertebrate Control Agents, Product
                         Performance Guidelines
------------------------------------------------------------------------
                                                       Guideline Title
                OCSPP guideline No.                        (Date)
------------------------------------------------------------------------
810.3000..........................................  General
                                                     Considerations for
                                                     Efficacy of
                                                     Invertebrate
                                                     Control Agents
                                                     (1998).
810.3100..........................................  Soil Treatments for
                                                     Imported Fire Ants
                                                     (1998).
810.3200..........................................  Livestock, Poultry,
                                                     Fur- and Wool-
                                                     Bearing Animal
                                                     Treatment (1998).
810.3300..........................................  Treatments to
                                                     Control Pests of
                                                     Humans and Pets
                                                     (March 1998).
810.3400..........................................  Mosquito, Black Fly,
                                                     and Biting Midge
                                                     (Sand Fly)
                                                     Treatments (1998).
810.3500..........................................  Premise Treatments
                                                     (2019).

810.3600..........................................  Structural
                                                     Treatments (1998).
810.3700..........................................  Insect Repellents to
                                                     Be Applied to Human
                                                     Skin (2010).
810.3800..........................................  Methods for Efficacy
                                                     Testing of Termite
                                                     Baits (2004).
810.3900..........................................  Laboratory Product
                                                     Performance Testing
                                                     Methods for Bed Bug
                                                     Pesticide Products
                                                     (2017).
------------------------------------------------------------------------

D. Guideline Modifications Needed for the Future

    Those guidelines from 2004 and before require revision to remove
any stated performance standards. Until the revisions can be made, this
rule would supersede any species requirements or performance standards
stated, or implied, in the guidelines applicable to invertebrate pests.
EPA intends that any inconsistency that may exist between the
guidelines and this rule should be resolved in favor of the
regulations, once those regulations are finalized.

V. Selection of Pest Categories for Subpart R

    EPA has selected three pest categories for this proposed rule:
Pests of significant public health importance, wood-destroying insects,
and invasive species. The rationale for selection of these three
categories follows.

A. Pests of Significant Public Health Importance.

    1. Background. As previously noted, in 2002, EPA issued Pesticide
Registration Notice (PRN) 2002-1 (Ref. 2), which presented the ``List
of Pests of Significant Public Health Importance.'' This document is
currently under revision within the Agency. The 2002 list was derived
in large part from review of the pesticide/pest combinations for which
product performance data have been required on a case-by-case basis to
be submitted and reviewed prior to registration. This list was
developed cooperatively by the U.S. Department of Housing and Urban
Development, USDA, and EPA, with input from some non-governmental
entities. EPA's Office of Pesticide Programs coordinated the review by
experts in public health and/or pesticide use patterns to compile this
list.
    As indicated in PRN 2002-1 (page 1), the criteria for inclusion on
the list were defined ``broadly, to include pests that pose a widely
recognized risk to significant numbers of people.''
    The listing of invertebrate pests (pages 6-9) is specified by the
taxonomic name, as not all members of a particular taxon may be
considered a pest of significant public health importance. EPA takes
this approach when only certain members of a taxonomic group may be of
public health significance because labels usually do not identify
specific individual species. However, even if the label did identify a
specific species, most product users are not able to distinguish among
the members of a taxonomic group (i.e., identifying one tick species
from another).
    The invertebrate species of significant public health importance
identified in this proposed rule as requiring submission of product
performance data are derived from the invertebrate pest list identified
in PR Notice 2002-1. Differences that exist between the species
identified in the PR Notice and this proposed rulemaking represent the
evolution of our understanding of the testing required to support
claims against pests of public health concern. These invertebrate pests
pose a threat of injury, disease transmission and/or pathogen transfer,
and allergen production. Table 3 provides the rationale for inclusion
in this rule of an invertebrate pest as a pest of significant public
health importance.

                     Table 3--Pests of Significant Public Health Importance From PRN 2002-1
----------------------------------------------------------------------------------------------------------------
             Invertebrate pest  (common species name)                         Rationale for inclusion
----------------------------------------------------------------------------------------------------------------
Mites............................................................  Produces allergens, Triggers asthma, Scabies,
                                                                    Itching and skin irritation with risk of
                                                                    secondary infection.
Chiggers.........................................................  Itching and skin irritation with risk of
                                                                    secondary infection.
Ticks............................................................  Rocky Mountain Spotted Fever, Lyme Disease,
                                                                    Ehrlichiosis.
Scorpions........................................................  Venomous sting.
Spiders..........................................................  Venomous bite.
Centipedes.......................................................  Venomous bite.
Lice.............................................................  Skin irritation and rashes, Epidemic typhus,
                                                                    Trench fever.
Fleas............................................................  Annoying bites, allergic reactions, and rash,
                                                                    Plague.
Cockroaches......................................................  Allergies, Transmission of Salmonella, Fecal
                                                                    contamination, Hepatitis.
Bot Flies........................................................  Infest host and live under the skin with risk
                                                                    of secondary infection.
Filth Flies......................................................  Carry pathogens, Food-borne illness.
Mosquitoes.......................................................  West Nile Virus, Dengue Fever, Malaria,
                                                                    Encephalitis, Yellow Fever, Chikungunya
                                                                    Fever, Zika.
Biting Flies.....................................................  Painful or annoying bites with allergic
                                                                    reactions.
Sand Flies.......................................................  Leishmaniasis.
Triatomine Bugs..................................................  Allergic reactions, Chagas disease.
Bed Bugs.........................................................  Bites and allergic reactions
Ants.............................................................  Stings to painful stings;, May be accompanied
                                                                    by severe or life-threatening reactions.
Bees.............................................................  Painful stings that may cause life-
                                                                    threatening reactions
Wasps, Hornets, and Yellowjackets................................  Painful stings that may cause life-
                                                                    threatening reactions
----------------------------------------------------------------------------------------------------------------

    2. Disease Pressures. EPA's proposal to establish product
performance data requirements for pesticide products claiming to
control invertebrate pests reflects the most up-to-date science and is
responsive to the improved

understanding of the diseases being transmitted by invertebrates and
the prevalence of these diseases. Since 1984, additional vector borne
diseases have emerged. Mosquitoes and ticks can no longer be considered
as merely annoying insects.
    West Nile Virus was first identified in the U.S. in New York in
1999. Since then, West Nile Virus spread throughout the country and
cases have been reported in the 48 contiguous states. West Nile Virus
is carried by common mosquitoes (primarily species of Culex, though
Aedes and Anopheles can also carry the virus).
     Serious Symptoms in a Few People--Approximately one in 150
people infected with West Nile Virus will develop severe illness. The
severe symptoms can include high fever, headache, neck stiffness,
stupor, disorientation, coma, tremors, convulsions, muscle weakness,
vision loss, numbness and paralysis. These symptoms may last several
weeks, and neurological effects may be permanent. This is referred to
as neuroinvasive West Nile disease and may result in death.
     Milder Symptoms in Some People--Up to 20 percent of the
people who become infected have symptoms such as fever, headache, and
body aches, nausea, vomiting, and sometimes swollen lymph glands or a
skin rash on the chest, stomach and back. Symptoms can last for as
short as a few days, though even healthy people have become sick for
several weeks. This is referred to as West Nile Fever.
     No Symptoms in Most People--Approximately 80 percent of
people (about 4 out of 5) who are infected with West Nile Virus will
not show any symptoms at all.
    Today, experts believe West Nile Virus is established as a seasonal
epidemic in North America that flares up in the summer and continues
into the fall. Persons over 50 years of age have the highest risk of
severe disease. (Ref. 13).
    The Zika virus spreads to people primarily through the bite of an
infected Aedes species mosquito (Ae. aegypti and Ae. albopictus). Zika
can be passed from a pregnant woman to her fetus, which can cause
certain birth defects. There is no vaccine for Zika. In 2015 and 2016,
large outbreaks of Zika virus occurred in the Americas, resulting in an
increase in travel-associated cases in the U.S., including widespread
transmission in Puerto Rico and the U.S. Virgin Islands, and limited
local transmission in Florida and Texas. In 2018 and 2019, there were
no reports of Zika virus transmission by mosquitoes in the continental
U.S. (Ref. 14).
    In the past 20-25 years, Lyme Disease has increased in geographical
distribution and in number of cases. The disease is carried by
blacklegged (deer) ticks (Ixodes scapularis and Ixodes pacificus). The
number and distribution of Lyme Disease cases correlates with the
number and distribution of white tail deer, among other animal hosts.
(Ref. 15). Deer populations have risen steadily in the last two
decades, especially in suburban areas. (Refs. 16 and 17).
    The first sign of infection is usually a circular rash, occurring
in approximately 70 to 80% of infected persons. It begins at the site
of a tick bite after a delay of 3-30 days and may gradually expand over
a period of several days. The center of the rash may clear as it
enlarges, resulting in a bull's-eye appearance. Patients also
experience symptoms of fatigue, chills, fever, headache, and muscle and
joint aches, and swollen lymph nodes. In some cases, these may be the
only symptoms of infection.
    Untreated, the infection may spread to other parts of the body
within a few days to weeks, producing an array of discrete symptoms.
These include loss of muscle tone on one or both sides of the face
(called facial or Bell's palsy), severe headaches and neck stiffness
due to meningitis, shooting pains that may interfere with sleep, heart
palpitations and dizziness due to changes in heartbeat, and pain that
moves from joint to joint. Many of these symptoms will resolve, even
without treatment.
    After several months, approximately 60 percent of patients with
untreated infection will begin to have intermittent bouts of arthritis,
with severe joint pain and swelling. Large joints are most often
affected, particularly the knees. In addition, up to 5 percent of
untreated patients may develop chronic neurological complaints months
to years after infection. These include shooting pains, numbness or
tingling in the hands or feet, and problems with concentration and
short-term memory.
    Most cases of Lyme Disease can be cured with antibiotics,
especially if treatment is begun early in the course of illness.
However, a small percentage of patients with Lyme disease have symptoms
that last months to years after treatment with antibiotics. (Refs. 18
and 19).
    Rocky Mountain Spotted Fever is the most severe tick-borne
rickettsial illness in the U.S. This disease is caused by infection
with the bacterial organism Rickettsia rickettsii; it is carried
primarily by dog ticks (Dermacentor variabilis) and wood ticks
(Dermacentor andersoni). The initial symptoms of Rocky Mountain Spotted
Fever include fever, nausea, vomiting, muscle pain, lack of appetite,
and severe headache. Later symptoms include rash, abdominal pain, joint
pain, and diarrhea. Pain and fluid loss can be so severe that
hospitalization may be required. (Refs. 20 and 21).
    EPA believes that tick and mosquito repellents have roles in
disease prevention. Today, there is renewed interest in methods of
preventing transmission of these diseases. CDC and other public health
authorities have determined that efficacious insect repellents have a
primary role in a multi-barrier approach in protecting the public from
insect or tick-borne diseases. CDC recommends several personal
protective practices to prevent tick and mosquito bites: One of the
most prominent and consistent messages is to use an insect repellent
containing an EPA-registered active ingredient. (Refs. 22 and 23).
    2. Bed Bugs. The U.S. has experienced a resurgence in the
population of bed bugs. Bed bugs can impact people's physical and
mental health. Physical impacts can include mild and severe allergic
reactions to the bites, and secondary infections of the skin. Reported
mental effects include anxiety and insomnia. (Refs. 7 and 8).
    Both the EPA and the CDC believe that an integrated pest management
program that combines both chemical and non-chemical treatments is the
most effective way to control bed bugs. Among the integrated pest
management methods, use of an effective pesticide product, labeled for
use against bed bugs, applied according to the label directions is
often necessary to control the population of bed bugs. (Ref. 8).
    3. Other pests of significant public health importance. Other
invertebrate pests cause painful bites and stings, provoke allergic
responses, and transmit serious diseases. As discussed in PRN 2002-1,
``cockroaches are controlled to halt the spread of asthma, allergy, and
food contamination'' and lice are controlled to prevent the
``occurrence of louse-borne diseases such as epidemic typhus, trench
fever, and epidemic relapsing fever in the United States.'' (Ref. 2).

B. Wood-Destroying Insects

    As previously explained, structural pests differ from pests of
significant public health importance because health of individuals is
not imperiled. However, the effectiveness of the treatment is not
readily apparent to the applicator at the time of application or

during the occupancy of the building or home, and a potential for
significant financial loss to the property owner exists. EPA has
generally required submission of product performance data for wood-
destroying insects for over 40 years. USDA registered pesticides prior
to establishment of the EPA and also required product performance data
in support of wood-destroying insects. The Agency issued PRN 96-7,
entitled ``Termiticide Labeling,'' (October 1, 1996) (Ref. 3) to
provide guidance on label statements and minimum levels of product
performance for soil treatment use of termiticide products. According
to the PRN:

    The Agency believes that registration of a [termiticide] product
demonstrating less than five (5) years of efficacy for control of
termites is generally not appropriate from a safety or efficacy
standpoint, considering the costs of treatment and the potential
damage that could occur. The Agency does not believe that the
homeowner should be subjected to such costly protection as would
occur with products that are only efficacious for one year. Such
products could, quite possibly, pose unreasonable adverse effects to
the environment and/or humans because of higher risks than longer-
acting alternatives. The more frequent treatments required could
result in greater exposure and risk, or lower benefits, because of
being less effective if not retreated, or more expensive if
retreated.
* * * * *
    EPA has always required efficacy data to be submitted by
registrants to demonstrate that termiticides perform their intended
function as claimed. EPA has reviewed such data prior to
registration to assure that the benefits of the use would outweigh
the potential risks.

C. Invasive Species

    On February 8, 1999, President Clinton signed The Executive Order
13112 (64 FR 6183) (February 8. 1999), which is intended to ``. . . to
prevent the introduction of invasive species and provide for their
control and to minimize the economic, ecological, and human health
impacts that invasive species cause . . . .'' The Executive Order
directed each federal agency to use relevant programs and authorities
to:
     Prevent the introduction of invasive species;
     Detect and respond rapidly to and control populations of
such species in a cost-effective and environmentally sound manner;
     Monitor invasive species populations accurately and
reliably;
     Provide for restoration of native species and habitat
conditions in ecosystems that have been invaded;
     Conduct research on invasive species and develop
technologies to prevent introduction and provide for environmentally
sound control of invasive species; and
     Promote public education on invasive species and the means
to address them.
    Invertebrate invasive species can impose serious economic costs by
causing or vectoring diseases against native species that have little
or no natural defenses. For example, an invasive species of significant
note is the emerald ash borer, a wood boring beetle that is native to
Asia. The emerald ash borer kills ash trees. Its presence was reported
in southeast Michigan and Windsor, Ontario in 2002. Since then it has
spread to at least 35 states and five Canadian provinces. Infested
areas are under quarantine and restrictions have been imposed on moving
fire wood. EPA has registered several pesticide products for use
against the emerald ash borer after reviewing submitted efficacy data.
(Ref. 24)
    Another invasive invertebrate species, the Asian longhorned beetle,
is also native to Asia and was first discovered in New York in 1996.
The Asian longhorned beetle kills maple trees and other hardwoods.
(Ref. 25). A very serious situation/crisis exists in New England, and
USDA has established an extensive eradication program. EPA has also
registered several products for use against the Asian longhorned
beetle.
    Invertebrates such as the emerald ash borer and the Asian
longhorned beetle kill trees over very large geographic areas, thus,
having substantial ecological and economic impacts by destroying both
urban cover and forests used for recreation purposes and timber stands.
According to a 2011 analysis (Ref. 26) entitled, ``Economic Impacts of
Non-Native Forest Insects in the Continental United States,'' the
following five categories of expenditures and losses can be used to
illustrate impacts on forests.
     Federal government expenditures (survey, research,
regulation, management, and outreach),
     Local government expenditures (tree removal, replacement,
and treatment),
     Household expenditures (tree removal, replacement, and
treatment),
     Residential property value losses, and
     Timber value losses to forest landowners.
    Within the 2011 analysis were cost estimates using the five
previously described categories of the damage caused by three types of
invasive insects: Borers, sap feeders, and foliage feeders. Since some
of the economic categories overlap, the total sum of all economic
categories would include some double counting. However, the total of
the insect types can be summed without double counting, which means
that it is appropriate to sum the columns, but not the rows. Table 4
shows that most of the costs are borne by local governments and
households, and the total damage is several billion dollars.

                            Table 4--Annualized Invasive Species Damages in the U.S.
                                                  [$ millions]
----------------------------------------------------------------------------------------------------------------
                                      Federal          Local                        Residential       Forest
                                    government      government       Household    property value     landowner
                                   expenditures    expenditures    expenditures        loss        timber costs
----------------------------------------------------------------------------------------------------------------
Borers..........................             $92          $1,700            $760            $830            $130
Sap Feeder......................              14             170             130             260               4
Foliage Feeders.................             110             170             160             410              18
                                 -------------------------------------------------------------------------------
    Total.......................             216           2,040           1,050           1,500             152
----------------------------------------------------------------------------------------------------------------

    Pesticide products are an important tool for managing the spread of
an invertebrate invasive species and the related 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. When circumstances necessitate the submission or
citation of reliable data to support claims for controlling invasive

species, EPA has the authority to require such product performance
data.
    Due to the sudden appearance and often rapid spread of invasive
species, EPA does not presently propose to codify a comprehensive list
of all the specific invasive species for which product performance data
might be deemed necessary. At this time, EPA is specifically proposing
to codify product performance data submission requirements for the
emerald ash borer and the Asian longhorned beetle. The submission of
product performance data to support claims for effectiveness against
other invasive invertebrate pests will be considered on a case-by-case
basis.

VI. Development of Invertebrate Pest Groups and Subgroups

    EPA has identified pest groupings on the basis of the biology and
life history characteristics of the pests identified as public health
or wood destroying pests. (Ref. 28). The groupings are taxonomically
based. ``Pest groups'' and ``pest sub-groups'' are designations simply
intended to convey the fact that some pests groups are part of larger
groups. Therefore, when practical, ``pest sub-groups'' have been
identified to define a meaningful subset of the larger group.
    EPA developed the pest groups and pest sub-groups with the
intention that product performance testing performed on a particular
species can adequately represent all members of the pest group (or pest
sub-group). The Agency intends these pest groupings to decrease data
submission burdens on applicants and data review burden on the Agency
as well as increasing the consistency, reliability, and integrity of
data submitted to EPA. In some cases, EPA is proposing pest-specific
claims, in addition to group and sub-group claims.
    To develop these groupings, EPA considered species sensitivity. In
certain cases, one member of a pest grouping is known to be
significantly harder to kill, control, or repel than other members of
the grouping. If product performance testing is performed using the
species that is harder to kill, control, or repel, then logically, it
can be assumed that the results of this testing can be extrapolated to
other members of the grouping. Additional considerations included the
availability of species in a laboratory setting, the occurrence of
species over wide areas and/or those species most commonly associated
with transmission of diseases to humans.

VII. Introduction to Part 158, Subpart R

A. General

    EPA is proposing to codify product performance data requirements
pertaining to registration of pesticide products claiming efficacy
against certain invertebrate pests. The proposed data requirements are
consistent with the Agency's current practices concerning the data
needed to register a pesticide product that claims effectiveness
against invertebrate pests.
    The proposed data requirements are presented, as appropriate, in
table formats, with the needed data specified according to the claim on
the label, the species to be tested, and the performance standards to
be met. Once final, the regulations will provide the regulated
community and other interested parties a better understanding of the
data required to support registration of a pesticide product making a
claim against an invertebrate pest identified to be a public health
concern (e.g., ticks, mosquitoes, cockroaches, etc.), a wood-destroying
insect (e.g. termites), or an invasive invertebrate species (e.g. Asian
longhorned beetle).
    The Agency is proposing to title the new subpart R in part 158,
``Product Performance for Products Claiming Effectiveness Against
Invertebrate Pests.'' The existing product performance data
requirements in subpart E will be renamed ``Product Performance for
Products Claiming Effectiveness Against Vertebrate Pests, Products with
Prion-related Claims, and Products for Control of Organisms Producing
Mycotoxins.'' Additionally, EPA is proposing conforming edits to
subparts U, V, and W.

B. Contents of Proposed Subpart R

    1. General requirements. Proposed 40 CFR 158.1700 contains the
general requirements that would be applicable to any pesticide product
that is making a claim(s) against an invertebrate pest, and describes
how to use the data tables in proposed subpart R. These general
requirements describe when product performance data may be required,
specifically for products that bear a claim against a pest of
significant public health importance or a pest of economic
significance. The required tests must be conducted using the end-use
product to ensure that the product's claims are supported in the form
in which the user will be using the product.
    Additionally, proposed 40 CFR 158.1700 provides a set of
instructions on how to determine the product performance data required
to support the pesticide product use for which registration is sought.
This includes referring to all parts of subpart R, identifying the
claims intended to be made on the product labeling, reviewing and
understanding the performance standards that must be met or exceeded
for the identified claims against the target pests, and understanding
all applicable test notes.
    2. Definitions. In order to ensure consistent implementation of
proposed subpart R, EPA is proposing definitions specific to the
subpart. Proposed 40 CFR 158.1701 and 158.1703 contain the definitions
pertaining to subpart R. In particular, proposed 40 CFR 158.1701
defines many of the terms that are needed to assure a common
understanding of the requirements and performance standards being
proposed for codification under subpart R.
    During the 2013 SAP, EPA received public comments and feedback from
the SAP on the proposed definitions in the Technical Support Document
(TSD) provided to the SAP. (Ref. 28). In addition, the SAP recommended
several additional definitions that should be considered under this
proposed rulemaking. After considering the comments provided, and based
on the data requirements being proposed in this rulemaking, the
proposed definitions represent those that are most essential for
understanding the requirements and regulatory text of the proposed
subpart R. For those definitions that the SAP and public commenters
provided feedback on or that were recommended then, but not included in
this proposal, EPA intends to consider the utility of those definitions
and will consider incorporating them into future guidance and
rulemakings. The SAP and public comments on definitions associated with
product performance data requirements are available in the docket for
the SAP [EPA-HQ-OPP-2012-0574]. EPA's response to those comments are
discussed in this document and associated docket. Other definitions
included in the TSD have since been adopted in testing guidelines.
    Where applicable, EPA derived the proposed subpart R definitions
from existing guidelines. The definition for Complete protection time
is very similar to the one found in Guideline 810.3700. The proposed
definition of Skin-applied insect repellent is taken from Guideline
810.3700. The proposed definitions for Soil-applied termiticides, and
Bait treatment were derived from information in Guidelines 810.3600 and
810.3800. For example, the Bait treatment proposed definition is
similar to Termite bait in Guideline 810.3800.

The definition of Vector is very similar to that in FIFRA 2(oo).
    In the TSD presented to the 2013 SAP, EPA explained a pesticide for
use against invertebrates and meeting one of the following
circumstances might be characterized as making a public health pest
claim requiring submission of product performance data:
     A claim is made to control, kill, knockdown, and/or repel
specific invertebrate organisms that are directly or indirectly
infectious or pathogenic or injurious to humans (or both humans and
animals). For example: A claim is made to repel mosquitoes and/or
ticks. Both mosquitoes and ticks transmit disease to humans. Or, a
claim is made to kill bed bugs. Bed bugs are injurious to humans.
     The pesticide product is used in public health programs
for vector control or for other recognized health protection uses to
prevent or mitigate threats to public health.
     The pesticide product contains one or more ingredients
that, under the criteria in 40 CFR 153.125(a), is an active ingredient
with respect to a public health organism and there is no other
functional purpose for the ingredient in the product.
     The pesticide product is similar in composition to a
registered pesticide product that makes explicit public health claims
for control of invertebrate organisms.
    EPA still agrees that these circumstances, in principle, identify
the kinds of pesticides for which product performance data may be
necessary. However, EPA is not proposing to codify the term ``public
health pest claim'' as a means of identifying when data are required.
Such a term is not necessary given the proposed regulatory text
includes sections that specify the invertebrate pests and invertebrate
pest groups/subgroups that would be subject to the proposed product
performance data requirements if the pesticide is intended for use
against those pests. EPA requests comment on whether there is utility
in codifying an overarching definition of a ``public health pest
claim'' for the purposes of subpart R, and if so, whether the
definition presented to the SAP is appropriate.
    In the 2013 TSD EPA wrote that:

    A public health claim is asserted if one or more of the
following apply:

--A claim is made to control, kill, knockdown, and/or repel specific
invertebrate organisms that are directly or indirectly infectious or
pathogenic or injurious to man (or both man and animals). For
example: A claim is made to repel mosquitoes and/or ticks. Both
mosquitoes and ticks transmit disease to man. Or, a claim is made to
kill bedbugs. Bedbugs are injurious to man.
--The pesticide product is used in public health programs for vector
control or for other recognized health protection uses to prevent or
mitigate threats to public health.
--The pesticide product contains one or more ingredients that, under
the criteria in 40 CFR 153.125(a), is an active ingredient with
respect to a public health organism and there is no other functional
purpose for the ingredient in the product.
--The pesticide product is similar in composition to a registered
pesticide product that makes explicit public health claims for
control of invertebrate organisms. (Ref. 28)

    EPA believes that the circumstances presented in the 2013 TSD, in
principle, identify the kinds of pesticides for which product
performance data may be necessary. EPA also notes that existing
regulations at 40 CFR 158.2204 provides definitions for a ``public
health claim'' and a ``nonpublic health claim'' as they pertain to
antimicrobial pesticide claims. EPA is not proposing to make any
modifications to that provision, and any definition for a ``public
health pest claim'' added to subpart R would be applicable only within
proposed subpart R.
    3. Application Categories. In proposed 40 CFR 158.1703, EPA is
proposing to define a set of application categories to assist in
defining the data needed to support registration. This section would
only define application categories to the extent the terms appear in
the proposed regulatory text and EPA believes they require definition.
For example, the terms ``bait treatments'' and ``spatial repellents''
are defined. This section does not provide a listing of all application
categories that would be covered by the proposed subpart R data
submission requirements.
    Application categories describe how and/or where the product is
intended to be applied or used. The proposed application categories
were derived after consideration of current practices and review of the
application sites included in the Harmonized Test Guidelines (810.3000
through 810.3900). Oftentimes, these application categories will be
used on pesticide product labeling, and, therefore, may be identified
as a product performance labeling claim within the data requirement
tables. Similar to the definitions in 40 CFR 158.1701, EPA received SAP
feedback on some of the application category definitions. (Ref. 29).
The application categories proposed in 40 CFR 158.1703 represent EPA's
responses to that feedback for the application categories as
applicable. These application categories are referred to in the
portions of the proposed regulatory text for the wood-destroying
invertebrate pests.
    4. Performance Standards. In proposed 40 CFR 158.1704, EPA is
proposing a set of performance standards that, in the absence of
performance standards specified elsewhere in subpart R, will apply
generally and must be met for data cited to be considered acceptable in
support of a specific labeling claim on the product's labeling.
    a. Performance standards for skin-applied insect repellents: EPA is
proposing that for skin-applied insect repellent labeling claims, the
performance standard must be greater than or equal to 2-hours complete
protection time.
    Complete protection time (CPT) is defined in Guideline 810.3700 as
``the time from application of a repellent until efficacy failure as it
is defined in each study--for example, the time from application until
the first efficacy failure event confirmed within 30 minutes by a
second similar event.'' CPT has been the existing practice for
determining efficacy of skin-applied insect repellents since the
guideline was finalized in 2010. EPA presented this concept, along with
a proposed minimum protection time of 2-hours, to the SAP in the TSD,
as a means of ensuring that a skin-applied repellency product protects
for a minimum amount of time given the potential variability of product
results across different people.
    The Agency believes that establishing a minimum CPT for skin-
applied repellency products should be required because of the large
variability in protection times experienced by susceptible individuals
in the population. The SAP agreed that this was a reasonable standard,
stating that ``[i]f CPT is to be used, a minimum CPT of 2 hours was
suggested by the Panel as a minimal criterion for product registration
. . . A repellent of shorter duration may not provide sufficient,
useful protection in practical terms and will give consumers a false
sense of protection.'' (Ref. 29).
    Additionally, EPA is proposing regulatory text for skin-applied
products that reinforces that any testing required under part 158 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 40 CFR part 158 testing requirements 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.
    b. Performance standards for products other than skin-applied
insect repellents. Unless otherwise specified in the proposed 40 CFR
158.1700-158.1786, EPA proposes that the performance standard for a
product performance claim against a pest must be greater than or equal
to 90 percent. For non-wearable spatial repellents, the proposed
performance standard is greater than or equal to 75%.
    In the TSD presented to the SAP, EPA was considering performance
standards of 95% for all other pest claims, with the exception of
mites, lice, carpenter ants, wood destroying beetles, and termites. The
95% performance standards were initially chosen because they
represented widely accepted standards at the time. (Refs. 28, 29, 30
and 31). EPA proposed these standards as a way to ``define the levels
of product performance that would need to be met in order for the
studies to support product registration and labeling,'' and that
proposing a specified threshold level or performance standard would be
the ``best means to assure that the products used to control
invertebrate species are effective under conditions of use.'' (Ref.
28).
    In response to the proposal, both the SAP and public commenters
believed that a 95% performance standard would create a burden for
unattainable results and would be cost prohibitive in most situations,
particularly for large scale field trials, or in general, any field
trial using a 100% standard expectation. They argued that a minimum 90%
performance under controlled laboratory conditions would be adequate.
(Refs. 28 and 29). While they made this recommendation, the SAP stated
that in special cases, EPA should retain the authority to overrule
these standards if proper justification is provided by the applicants
with regard to why the standards should not be applicable to a
particular product. Additionally, the SAP stated that registrants
should be allowed to compete by achieving higher than required
performance standards, proving the superiority of their products.
    After considering the SAP and public comments, with the exception
of pests such as human mites, carpenter ants, termites, and wood-
destroying beetles, EPA is proposing performance standards of 90% or
greater instead of 95%. EPA believes that this standard will enable
acceptance of registrations for products that provide a satisfactory
level of control. Human mites and lice will retain a 100% standard,
while the wood-destroying pests will have a 95% or greater standard for
prevention of damage to wood, except for non-structural wood
preservative treatments, which will have a standard of 100%. The
standards for human mites, lice, and wood-destroying pests will be
discussed in more detail in other sections of this proposed rule.
    5. Test Guidelines. In proposed 40 CFR 158.1705, EPA is codifying a
reference to EPA's Harmonized Test Guidelines, which set forth a
recommended approach to generate the data required for product
performance testing.
    6. Data Requirement Modifications. In proposed 40 CFR 158.1707, EPA
is proposing to state that on a case-by-case basis, the data
requirements identified in subpart R may need to be adjusted for novel
technologies or because a product's unusual physical, chemical, or
biological properties or atypical use patterns would make particular
data requirements inappropriate, either because it would not be
possible to generate the required data or because the data would not be
useful in the Agency's evaluation of the risks or benefits of the
product. EPA recommends that registrants of novel technologies contact
the Agency prior to conducting product performance testing. It should
be noted that EPA has historically taken the position that data
requirements can be adjusted or waived on a case-by-case basis per the
procedures described in 40 CFR 158.45. This provision is not intended
to supersede or alter the provisions at 40 CFR 158.45, but rather to
clarify that EPA is proposing that the data requirements, including the
performance standards, in subpart R may also be adjusted using the
procedures consistent with those in 40 CFR 158.45.
    7. Invasive Species Claims. In proposed 40 CFR 158.1708, EPA is
proposing that when an application for registration or amended
registration requests to put a claim(s) on its pesticide product's
labeling for effectiveness against an invasive invertebrate species,
then on a case-by-case basis, EPA may require submission of product
performance data to support those claims for effectiveness. Due to the
sudden appearance and often rapid spread of invasive species, EPA does
not presently intend to codify a comprehensive list of the specific
invasive species for which product performance data might be deemed
necessary. USDA maintains a list of invasive species profiles, which
can be used as guidance. (Ref. 32). EPA is specifically proposing to
codify product performance data submission requirements for the emerald
ash borer and the Asian longhorned beetle. The submission of product
performance data to support claims for effectiveness against other
invasive invertebrate pests will be considered on a case-by-case basis.
    EPA notes that the Agency currently has authority to require data
submission on a case-by-case basis when necessary to evaluate a
pesticide product (see 40 CFR 158.75). This provision is intended to
clarify that whether or not a claim is against an invasive species is a
factor in determining whether product performance data is necessary to
evaluate a pesticide.
    8. Invertebrate Disease Vector Claims. In proposed 40 CFR 158.1709,
EPA is proposing that if a registrant requests a labeling claim
specific to a disease vector, additional testing conducted with the
species specific to that disease vector claim is required if that
species is not already required under subpart R as part of the pest
group tested. For example, if a product claims to repel Asian
longhorned ticks that may carry Japanese spotted fever, caused by
Rickettsia japonica, then the registrant must generate data using the
species that is known to carry the disease indicated, the Asian
longhorned tick in this case. This requirement will ensure that all
disease vector claims are supported by appropriate product performance
data demonstrating the required performance standard should an unknown
public health threat emerge in the future.
    9. Structural and Wood-destroying Pest Claims. In proposed 40 CFR
158.1710, EPA is proposing that if an application for registration or
amended registration requests a labeling claim specific to a structural
or wood-destroying pest that is not identified in 40 CFR 158.1782
through 158.1786, EPA may require submission of product performance
data to support those claims for effectiveness. This requirement will
ensure that any claim against structural and wood-destroying pests that
have not been accounted for at this time are supported by product
performance data in the event that a new threat emerges.
    10. Pest Specific Claims. EPA is proposing to codify product
performance data submission requirements for pest groups, sub-groups,
and some specific species. EPA uses the term ``Pest group labeling
claim'' to mean 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. The term
``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. The term
``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.
    In addition to the group and sub-group claims, EPA is proposing to
codify requiring product performance data for a number of pest-specific
claims. As previously noted, the representative test species 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, as well as other factors including their
availability for laboratory testing, ubiquity, and whether they are one
of the primary drivers of the human health concerns within a grouping.
(Ref. 1). The 2013 TSD envisioned that in many cases ``[i]f
representative taxa are provided, species specific data may not be
required, as the group and any/all individual species within the group
can be supported by supporting the general claim.'' (Ref. 28).
    For pests that are not listed as a ``pest-specific claim'' in
proposed subpart R, EPA proposes that the data required to support a
group claim would also be sufficient to support pest-specific claims
for species within that group. For example, the pavement ant
(Tetramorium caespitum) is not listed as a pest-specific claim in
proposed subpart R because it is not a pest of significant public-
health importance (nor is it a wood-destroying insect) and no pest-
specific product performance data would need to be submitted to add a
claim against pavement ants to a label. In contrast, cluster flies
(Pollenia rudis) are listed as a pest-specific claim in this proposed
rule because of their significant public health importance. These pest-
specific claims are consistent with EPA's current practices. Thus,
consistent with the Agency's current practices, pest-specific data
would need to be submitted to add a pest-specific claim against cluster
flies to a label in addition to any data submitted to support the group
claim against ``filth flies.'' EPA also notes that the provisions at 40
CFR 158.75 and proposed 40 CFR 158.1708 would also permit the EPA to
require pest-specific data on a case-by-case basis when necessary to
evaluate a pesticide product. These provisions allow EPA to address the
Agency's data needs in the face of emergent invertebrate pest concerns.
    EPA requests comment on the pest-specific claims covered by this
proposed rule and whether there should be additional pest-specific
claims added to subpart R, or if some of the ones included in the rule
are unnecessary.

C. Data Requirements for Subpart R

    The data requirements that EPA is proposing for codification are
consistent with the Agency's current practices when considering the
product performance data needed to register a pesticide product that
bears a pesticidal claim against one or more of these pests or pest
groups/sub-groups. FIFRA section 3(c)(2) directs EPA to specify the
kinds of data that applicants and registrants must submit to EPA to
support regulatory determinations under FIFRA. The data requirements
for pesticide products are codified in 40 CFR part 158.
    Product performance data (efficacy studies) document how well the
product performs the intended function (such as killing or repelling)
against an invertebrate pest. The product performance data needs being
considered in this rule would link the labeling claim for pesticide
products claiming efficacy against an invertebrate pest with the data
needed to substantiate that claim. EPA views these standards as
performance standards for the acceptability of data, and thus EPA views
them as waivable under 40 CFR 158.45.
    1. Mites (excluding Chiggers). In 40 CFR 158.1712, EPA is proposing
the required test species and performance standards in order to make a
labeling claim against dog follicle mites, dust mites, and the human
itch or scabies mite. EPA is proposing to list chiggers, which are
mites, in a separate section.
    As indicated in the TSD presented to the SAP, dog follicle mite
infestations are typically commensal in nature, but can cause
demodectic mange in susceptible animals. This can pose a serious risk
to stricken individuals, which typically have pre-existing immune
system issues. For this reason, a 100% performance standard is being
considered for these applications.
    Dust mites pose no direct threat of injury, disease transmission,
or discomfort. However, dust mites are included as a pest of
significant public health importance because they produce allergens in
their feces and cast exoskeleton that can result in asthma and allergic
reactions. EPA believes that it is impractical to expect complete
elimination of the dust mite population in a structure. The focus
should be to reduce the agent of concern (i.e., the allergen) to
acceptable levels. This can be achieved through a reduction in the
target pest that is less than is generally necessary for a pest that
acts directly against its host. EPA initially proposed a 75%
performance standard to the SAP for surface and fabric treatments, and
a 95% performance standard for direct application to dust mites.
However, after considering the responses received through the SAP and
public comment, EPA is proposing a 90% performance standard for dust
mites to be consistent with the recommendations provided on the
performance standards for other species testing.
    During the SAP, one commenter indicated that for mites, the
proposed performance standard of 100%, as considered by EPA, was too
high. Instead the commenter advocated for 90%, while indicating that
95% would be achievable. (Ref. 33). The 90% standard is being proposed
for some labeling claims for the dog follicle and dust mites, but for
human itch or scabies mites, EPA disagrees with lowering the
performance standard since scabies mites directly infect and are easily
transferred among hosts. A human skin-applied topical repellent
performance standard of >=2-hour complete protection time is also being
proposed.
    EPA also notes that any testing conducted with human subjects must
comply with all applicable requirements under 40 CFR part 26.
    2. Chiggers. In the proposed 40 CFR 158.1714, EPA is proposing to
require testing for labeling claims against chiggers. Chiggers are
being proposed in the rulemaking due to their bites causing itching and
skin irritation with the risk of a secondary infection. Additionally,
EPA is proposing the performance standards established under 40 CFR
158.1704 to apply to testing for chiggers.
    During the SAP, the Panel noted that Trombicula alfreddugesi (as
presented in the TSD) is now renamed as Eutrombicula cinnibars. EPA was
unable to verify this and has maintained Trombicula alfreddugesi as was
presented in the TSD. EPA requests comment on whether this is correct,
and

if the name has changed, EPA requests a reference to the revised name.
    3. Ticks. In the proposed 40 CFR 158.1718, EPA is proposing to
require the test species and performance standards to labeling claims
against ticks, cattle ticks, and soft ticks. EPA is proposing several
tick species due to their potential to transmit diseases, such as Rocky
Mountain Spotted Fever, Lyme disease, and ehrlichiosis. For performance
standards, EPA is proposing standards consistent with 40 CFR 158.1704.
    To make a claim against ``ticks,'' EPA is proposing to require a
total of three hard tick species as representative of ticks in general.
As presented in the TSD and based on recommendations from the SAP,
products claiming ``ticks'' must test for the blacklegged tick (Ixodes
scapularis) and lone star tick (Amblyomma americanum), and a third
species tested must be either the American dog tick (Dermacentor
variabilis), the brown dog tick (Rhipicephalus sanguineus), or, as
suggested by the SAP, the Rocky Mountain wood tick (Dermacentor
andersoni). Because ticks are high stakes disease vectors and because
consumers have difficulty differentiating between species, for a claim
against any specific species of ``ticks'' all the representative
species for the ``ticks'' claim must be tested. In addition, because
these are pests of significant public health importance that the public
strongly associates with the diseases they vector, EPA would also
require submission of data on the specific pest claimed. EPA does not
typically receive pest-specific claims for ticks other than those that
are representative species for ticks. However, the Asian longhorn tick
is an emergent pest in this category and EPA would require pest-
specific data for a pest-specific claim against the Asian longhorn tick
or any other pest specific tick claim. This would be in addition to
testing on the representative species.
    In addition to the required test species for a ``tick'' labeling
claim, EPA is also proposing specific parameters regarding required
species for ``ticks'' under certain testing circumstances. These
specific parameters include:
    i. For products intended to be applied to dogs, testing is required
on three species: Blacklegged tick (Ixodes scapularis), American dog
tick (Dermacentor variabilis), and brown dog tick (Rhipicephalus
sanguineus).
    ii. For products intended to be applied to cats, testing is
required on three species: Blacklegged tick (Ixodes scapularis), lone
star tick (Amblyomma americanum), and American dog tick (Dermacentor
variabilis).
    The species identified under each of these circumstances were
identified as a result of their occurrence on dogs and cats and the
biology/behavior of the ticks.
    For a claim against cattle ticks, EPA is proposing testing on
either the Southern cattle tick (Rhipicephalus microplus) or the cattle
fever tick (Rhipicephalus annulatus). When presented to the SAP, the
SAP noted that if pests of veterinary importance are not the primary
objective for this proposal, then pests such as cattle ticks should be
removed from the tables. While the emphasis is on pests of significant
public health importance and wood-destroying insects due to their
significant economic impacts, EPA maintains that cattle ticks should be
included in this proposal because of the potential for these ticks to
carry diseases such as Texas cattle fever, which can result in
significant economic losses to the cattle industry. (Ref. 34)
Additionally, the cattle fever tick poses a risk to a small, but highly
vulnerable population of humans. Specifically, those people that have
had splenectomies are susceptible to a potentially fatal bovine
babesiosis infection from an infected cattle fever tick. (Ref. 35).
    For a claim against soft ticks, EPA is proposing testing on the
species Ornithodoros hermsi. Humans typically come into contact with
soft ticks when they sleep in rodent infested cabins. The ticks emerge
at night and feed briefly while the person is sleeping. The bites are
painless, and most people are unaware that they have been bitten. These
ticks may transmit tick-borne relapsing fever (Borrelia hermsii, B.
parkerii, or B. turicatae).
    4. Scorpions. In proposed 40 CFR 158.1722, EPA is proposing to
require data for a ``scorpion'' labeling claim due to their venomous
sting. In the TSD to the SAP, EPA proposed to only require the striped
bark scorpion (Centruroides vittatus). For scorpions, EPA is proposing
the performance standards under proposed 40 CFR 158.1704.
    One public commenter during the SAP questioned why EPA provided
only one species for testing, stating that they believed this to be too
restrictive. (Ref. 36). EPA chose the striped bark scorpion as the
required test species because it is a larger species of scorpion, and
larger species can be harder to kill. Using such a species as the
required test species means greater certainty that testing on one
species would be representative of testing on other species. The
commenter did not provide the name of a species that they consider
suitable for testing. The Agency would welcome information to better
inform the decision on selection of a suitable test species for
scorpions.
    5. Spiders. In proposed 40 CFR 158.1726, EPA is proposing data
requirements for one pest group (Spiders), one pest sub-group (black
widow spiders), and five pest-specific spider claims. EPA's current
practice for spiders is to require product performance data to be
submitted with certain species-specific claims (e.g. ``Northern black
widow spider''), certain pest-subgroup claims (e.g., ``black widow
spiders''), or pest-group claims for either ``spiders'' or ``spiders
unless the label expressly excludes black widow or brown recluse
spiders.'' The black widow and the brown recluse spiders can deliver
bites with potentially serious medical implications, and therefore are
considered pests of significant public health importance. Thus, if an
applicant submits a draft label with a labeling claim for ``spiders
(excluding black widow or brown recluse),'' the applicant does not need
to submit product performance data to EPA with an application for
registration. Instead, the applicant would generate product performance
data to confirm that the product is effective against these pests and
hold those data in their files. In contrast, a general ``kill spiders''
claim encompasses pests of significant public health importance, i.e.,
the black widow and brown recluse spiders, and therefore, the applicant
would need to submit two product performance studies to EPA to verify
this claim, one study each for the brown recluse spider and black widow
spider (either Northern black widow spider, the Southern black widow
spider, or Western black widow spider).
    For the performance standards, EPA is proposing standards
consistent with proposed 40 CFR 158.1704.
    6. Centipedes. In proposed 40 CFR 158.1732, EPA is proposing data
requirements for centipedes. EPA proposes testing on either the house
centipede, the Florida blue centipede, or on one species from the
Scolopendra genus. For the performance standards, EPA is proposing
standards consistent with proposed 40 CFR 158.1704.
    The SAP noted that centipedes are generally harmless and considered
beneficial insects, behaving as active predators of other arthropod s
within structures. Although a species such as the Florida blue
centipede (Hemicolopendra marginata) can inflict a painful bite, the
SAP questioned whether it was sufficient to include

centipedes as a pest of significant public health importance. While
some species of centipedes may be ``harmless,'' species such as the
Florida blue centipede can envenomate with painful bites, which can be
categorized as similar to that of a bee sting. Effects can include
anaphylactic shock in some individuals. EPA believes that these types
of effects are sufficient to be considered as a pest of significant
public health importance, and are thus included in this proposed
rulemaking.
    7. Lice. In proposed 40 CFR 158.1736, EPA is proposing data
requirements on either the Head louse or the Body louse in order to
make a labeling claim against lice. EPA is also proposing a performance
standard of 100% for all efficacy claims made against lice. The SAP did
not express any opinions on the proposed required test species or
performance standards.
    8. Fleas. In proposed 40 CFR 158.1740, EPA is proposing data
requirements for one pest group (Fleas) and six pest-specific claims
(cat flea, chigoe flea, dog flea, hen flea, human flea, and oriental
rat flea). For the performance standards, EPA is proposing standards
consistent with proposed 40 CFR 158.1704.
    Historically, EPA has only required testing on the cat flea in
order to make a ``flea'' claim. The cat flea is common and easy to rear
in the laboratory. Additionally, because the cat flea is the most
common species that infests pets, most of the available pesticide
products target the cat flea.
    In the SAP response to the TSD, the Panel suggested adding the
oriental rat flea (Xenopsylla cheopis) in addition to the cat flea for
a ``flea'' labeling claim. The oriental rat flea (also known as the
tropical rat flea) is a vector for bubonic plague (caused by Yersinia
pestis), which is extremely rare in the U.S. EPA does not believe
requiring this additional species provides immediate benefits at this
time and would be an additional cost and burden on applicants to
provide such data. EPA notes that 40 CFR 158.1709 would cover
invertebrate diseases vector claims. In the future, if the plague
becomes a significant issue in the U.S., then EPA would consider
requiring the submission of data on the oriental rat flea in addition
to the cat flea. Since the risk of the oriental rat flea is rare, EPA
intends to continue with its existing practice to only require the
larger cat flea for a ``flea'' claim, and is therefore proposing it as
the only required test species at this time.
    9. Cockroaches. In proposed 40 CFR 158.1744, EPA is proposing data
requirements for one pest group (cockroaches) and seven pest-specific
claims (American cockroach, Australian cockroach, brown cockroach,
brownbanded cockroach, German cockroach, oriental cockroach, and the
smokybrown cockroach). For the performance standards, EPA is proposing
standards consistent with proposed 40 CFR 158.1704.
    For the ``Cockroach'' pest group claim, EPA has historically
required testing on both the American cockroach and the German
cockroach, and is proposing to codify this requirement. These are the
most common cockroaches requested on product labels and are commonly
controlled to halt the spread of asthma, allergy, and food
contamination. The SAP was supportive of these species as the required
test species for this pest group claim.
    The SAP suggested adding Periplaneta fuliginosa and P. brunnea
(smokybrown and brown cockroach, respectively) to the cockroach pest
group. EPA is proposing these pests as a pest-specific labeling claims.
Even with these additions, EPA continues to believe that for a general
cockroach claim, the German and American cockroach are appropriate
representative test species for the overarching pest group.
    The Turkestan cockroach (Blatta lateralis) is thought to be
displacing the Oriental cockroach in the southwestern U.S. and, like
other cockroaches, can transfer food-borne pathogens. Because of this
development, EPA is adding a pest-specific claim for the Turkestan
cockroach to 40 CFR 158.1744.
    10. Keds, Screwworms, and Bot Flies. In proposed 40 CFR 158.1748,
EPA is proposing data requirements for bot flies (excluding human bot
fly), the human bot fly, keds, and screwworms. For the performance
standards, EPA is proposing standards consistent with proposed 40 CFR
158.1704.
    For bot flies (excluding human bot fly), EPA is proposing to
require testing on one of the three following species: Horse bot fly,
throat bot fly, or the nose bot fly. The SAP suggested specifying the
test species as Gasterophilus spp. instead of listing three specific
Gasterophilus species, as specified in the TSD. EPA continues to
believe that testing on either the horse bot fly, throat bot fly, or
the nose bot fly were the most appropriate for efficacy testing because
they are large and can be found throughout the U.S. While they are
primarily pests of horses, larvae of these three species may
occasionally parasitize humans.
    For the human bot fly, EPA is proposing testing on the human bot
fly (Dermatobia hominis). The human bot fly is not known to vector
disease, but the larvae will infest the skin of mammals and live out
the larval stage in the subcutaneous layer, causing painful pustules
that secrete fluids. The infestation of any fly larvae inside the body
is known as myiasis. (Ref. 37). Under bot flies, the SAP stated that
human bot fly should be retained as this is frequently introduced by
travelers.
    In addition to the three proposed options for bot flies, the SAP
also suggested EPA consider the Hypoderma spp. and Oestrus ovis (the
sheep bot fly) as additional options. EPA is not proposing to include
these species since the Agency has not historically required or
received data on these pests. However, EPA requests public comment on
whether there is a need to codify product performance data requirements
for Hypoderma spp. and Oestrus ovis.
    For screwworms, EPA is proposing to require testing on either the
screwworm (Cochliomyia hominivorax) or the secondary screwworm
(Cochliomyia macellaria). The SAP indicated that Cochliomyia
hominivorax is an eradicated species in the U.S. While EPA acknowledges
that the sterile insect eradication program was a success, the species
was recently found in Florida. If, in the future, an applicant wanted
to make a label claim against screwworms, then Cochliomyia hominivorax
would be the appropriate test species. Providing this option provides
flexibility to the pesticide registrant. (Ref. 38).
    For keds, EPA is proposing to require testing on the sheep ked. The
sheep ked has historically been the representative species for a
``keds'' claim, and the SAP expressed general support of the Sheep ked
as the required test species. Therefore, EPA is proposing to maintain
this practice.
    11. Filth Flies. In proposed 40 CFR 158.1752, EPA is proposing data
requirements for one pest group claim against ``Filth flies'' and six
pest-specific claims (blow fly, cluster fly, face fly, flesh fly, house
fly, and little house fly). For the performance standards, EPA is
proposing standards consistent with proposed 40 CFR 158.1704.
    For a ``Filth Flies'' pest group claim, EPA is proposing to require
testing on the house fly (Musca domestica) and either one species of
flesh fly (Sarcophaga spp., Wohlfahrtia spp., and other genera of flesh
fly) or one species of blow fly (Phaenicia spp., Calliphora spp., and
other genera of blow fly). One public commenter during the SAP
questioned why EPA asked for testing in two species. The commenter
indicated that for a direct spray application, only

testing with the house fly is needed. The commenter suggested that
testing with more than one species should only be needed for more
specialized claims, such as fly baits. (Ref. 36).
    In response, EPA included house flies and the option to select
between blow flies and flesh flies because these types of flies move
bacteria around from place-to-place when they land. This takes place by
touching surfaces, as these flies generally do not bite. ``Filth
flies'' is a large grouping and testing on two species provides greater
assurance that the product would be effective against most members of
the pest group. House flies are generally the smallest in size of these
three groups and therefore may be more susceptible to insecticides.
Testing against the larger filth flesh/blow flies reduces the
likelihood of overestimating efficacy.
    Additionally, the SAP suggested the cluster fly (Pollenia rudis) be
deleted as a test species. Instead, flies in the genus Fannia can be
included since they can be relatively easy to rear in laboratory
conditions. Fannia benjamini complex and Fannia scalaris (canyon fly
and latrine fly) were specifically mentioned. In response, the cluster
fly was not listed as a required test species for a claim against
``Filth Flies'' in the TSD. The cluster fly was specified as a test
species if an applicant makes a pest-specific claim against the cluster
fly. Because house flies, blow flies, and flesh flies are considered
better representative species for the pest group claim against ``Filth
Flies,'' flies in the genus Fannia are not considered a representative
alternative to cluster flies.
    12. Mosquitoes. In proposed 40 CFR 158.1756, EPA is proposing data
requirements for a pest group claim against ``Mosquitoes.'' For the
performance standards, EPA is proposing standards consistent with
proposed 40 CFR 158.1704. For the required test species, EPA is
proposing that testing be required on at least one mosquito species
from three different genera (i.e., one out of three proposed Culex
spp.; one out of two proposed Aedes spp.; and one out of six proposed
Anopheles spp.).
    One public commenter during the SAP asked why the species Anopheles
stephensi was missing from the list of species for mosquito testing in
the TSD, as it is a common, representative lab insect. (Ref. 36). EPA
agrees that the Anopheles stephensi could be used for testing, and has
added Anopheles stephensi to the list of species for mosquito testing
in EPA's proposal.
    Additionally, the SAP comments were much more extensive regarding
mosquitoes, as the SAP response covered both required test species as
well as how one arrives at conducting the tests to collect the data.
These comments are, as follows:

 Suggested having separate tables for killing and repelling and
for field and lab testing
 Questioned the suitability of Culex pipiens and C.
quinquefasciatus in repellent studies
 Suggested using Culex spp. instead of hybrids C. pipiens and
C. quinquefasciatus
 Indicated Anopheles freeborni and A. punctipennis are suitable
for field testing and not lab testing
 Indicated Anopheles quadrimaculatus is not suitable for indoor
repellent testing
 Suggested adding Anopheles albimanus and Anopheles stephensi
 Indicated Psorophora is acceptable for field testing

    The SAP also noted that for field testing of mosquitoes, certain
species provided in EPA's list could not readily be obtained in a field
test in the U.S.
    In response, EPA agrees that a listing of specific mosquito test
species as provided in the TSD was confusing when considered in the
context of field testing. With lab testing and semi-field or ``caged''
testing a particular test species can be selected. The particular
species selected for testing could depend on the colonies maintained by
the laboratory, as well as the type of product being tested, and EPA
believes providing a list of representative species that is
comprehensive means that an appropriate species could be identified for
a wide variety of product types or claims.
    With regards to Culex pipiens and Culex quinquefasciatus, EPA is
aware that these are now considered to be a hybrid mosquito complex.
However, EPA believes that retaining the historical names of the Culex
species provides more appropriate context, given the possibility of
more name changes over time.
    With regards to Anopheles mosquitoes, EPA has provided several
species for the applicant to consider because some Anopheles mosquitoes
may not be appropriate for all types of testing, or colonies of some
Anopheles mosquitoes may be difficult to maintain in a laboratory.
Additionally, EPA is proposing to add Anopheles albimanus and A.
stephensi.
    EPA agrees that Psorophora might be reported in a field study. Even
though this is another genus of mosquito, Psorophora is not a major
vector of diseases in the U.S. Other species may better inform the
decisions that EPA needs to make.
    For testing of skin-applied insect repellents, EPA's Guideline
810.3700, entitled, ``Insect Repellents to be Applied to Human Skin''
provides specific guidance (page 27) on the choice of field testing
sites. (Ref. 39). According to the Guidance, ``Field tests for mosquito
repellency should be conducted in at least two distinct habitats (e.g.,
forest, grassland, salt marsh, wetland, beach, barns, or urban
environments) where the predominant mosquito species differ.''
    In field testing, a wide variety of species are encountered. Thus,
for field testing, the applicant's submission will provide information
on the species captured during the testing. EPA will review the data
submitted to determine if a sufficient number and type of species were
present. Generally, EPA expects three different genera to be present:
Culex, Aedes, and Anopheles.
    Claims against specific vector/disease combinations must be
supported by testing of the specified vector. Additionally, because
mosquitoes are high stakes vectors and because of the difficulty
consumers have in differentiating between species, for a claim against
any specific species of mosquito, all the required test genera must be
tested.
    EPA also agrees that certain species of the mosquitoes specified in
the TSD might not be obtained in a field test. However, the purpose of
providing multiple species is to offer flexibility in how one complies
with the data requirements. In the proposal, EPA has not differentiated
between what species may be more obtainable in a field versus
laboratory test.
    Additionally, two commenters provided other comments about how to
obtain mosquito data, particularly in relation to using foreign data
and foreign species as surrogate data. One commenter, for example,
suggested that foreign data be considered acceptable as long as the
study is conducted according to the 810.3700 guidelines. (Ref. 40).
Another commenter indicated that foreign species could be useful if
sufficient colonies of domestic species are not available (e.g.,
declining colonies of US anopheline mosquito species). (Ref. 41). EPA
would like to note that conducting studies according to EPA guidelines
is always recommended, but is not enough to show that a foreign species
is an acceptable surrogate for a domestic species. However, the Agency
acknowledges that situations may arise where data showing efficacy of a
product against foreign species can be

useful. Therefore, the Agency will consider bridging data from foreign
species to domestic species on a case-by-case basis. With this in mind,
EPA is seeking comment on whether other species should be considered as
part of the required test species.
    13. Biting Flies. In proposed 40 CFR 158.1765, EPA is proposing
data requirements for the pest group ``Biting flies (excluding Sand
flies),'' the pest sub-groups ``Large Biting Flies'' and ``Small Biting
Flies (excluding Sand flies),'' and nine pest-specific claims of biting
flies. For the performance standards, EPA is proposing standards
consistent with proposed 40 CFR 158.1704.
    Since the SAP, the Agency has revised the proposed data
requirements to be clearer than initially presented to the SAP. EPA
proposed the pest group ``Biting flies (excluding Sand flies)'' to be
consistent with experience on how the Agency receives labeling
requests. Sand flies are vectors for Leishmaniasis, a parasitic disease
that is found in parts of the tropics, subtropics, and southern Europe
which can either cause skin sores or affect several internal organs
(usually spleen, liver, and bone marrow). (Ref. 42). This
differentiation improves the clarity and is consistent with how
products have typically been labeled.
    The Agency is also proposing to split the pest sub-groups further
into ``Large Biting Flies'' and ``Small Biting Flies (excluding Sand
flies).'' This is in response to the fact that periodically, the Agency
receives requests for claims against large biting flies or claims
against small biting flies. This proposal is to provide that
flexibility in the codified data requirements.
    During the SAP, the Panel suggested that the stable fly (Stomoxys
calcitrans) and the horn fly (Haematobia irritans) be included in the
filth fly category. The Panel also questioned why both species need to
be tested. In response, EPA considers both the stable fly and the horn
fly to be biting flies. The Agency is proposing stable flies as one of
the three representative species for the ``Biting Fly (excluding sand
flies)'' pest group claim and one of the two required test species the
``Large Biting Flies'' pest sub-group claim. Testing of both species as
described in the TSD to obtain a claim against stable flies was an
error. Instead, in the absence of an appropriate pest group or pest
sub-group representation, the Agency is proposing to require testing
against stable flies for a pest-specific efficacy claim against stable
flies and testing against horn flies for a pest-specific claim against
horn flies.
    The SAP suggested adding Leptoconops kereszi complex and L. torrens
(black gnats) to pest sub-group biting midges in the TSD. For claims
against biting midges, the Agency was proposing testing against one
Culicoides species and one Leptoconops species. The specific species of
Leptoconops required are not specified; therefore EPA would consider
the species suggested by the commenter (Leptoconops kereszi complex and
L. torrens) to be acceptable. The biting midges pest sub-group has
since been revised to be represented as the ``Small Biting Flies
(excluding Sand flies)'' pest sub-group claim. Both biting midges and
black gnats are listed separately under the pest-specific claims.
    14. Bed Bugs. In proposed 40 CFR 158.1768, EPA is proposing data
requirements for the pest group claim ``Bed bugs'' and pest-specific
claims for both the Common bed bug and the Tropical bed bug. For the
performance standards, EPA is proposing standards consistent with
proposed 40 CFR 158.1704.
    For ``Bed bugs,'' one commenter indicated that only one species is
important to the vast majority of consumers and thus only one species
needs to be tested to support this kind of product registration. For
this proposal, EPA agrees that testing to include only the common bed
bug, Cimex lectularius, is appropriate as the lone required bed bug
test species.
    In the TSD, the EPA initially proposed a 95% performance standard
for bed bug products. One commenter stated that the performance
standard for bed bug control products that claim residual control and
ovicidal control should be 90% rather the 95% standard in the TSD.
Additionally, the commenter indicated that bed bug products need to
have residual activity, because control of bed bugs is not possible via
direct contact. They indicated that there must be residual activity in
order for the product to claim ``control'' and if the product does not
have residual activity, then this statement should be on the product
label. The commenter also stated that a performance standard applicable
to bed bug products that claim to kill bed bugs when bed bugs come into
contact with a treated surface is needed. Therefore, EPA has decided to
propose a performance standard of 90%, instead of the 95% in the TSD.
    15. Conenose Bugs and Kissing Bugs. For proposed 40 CFR 158.1772,
EPA is proposing data requirements for labeling claims against conenose
bugs and kissing bugs. For the performance standards, EPA is proposing
standards consistent with proposed 40 CFR 158.1704.
    Initially proposed as ``True bugs (excluding bed bugs)'' in the
TSD, EPA is proposing to focus primarily on the two required test
species, the conenose bug and the kissing bug. This proposal has now
separated them as pest-specific claims since experience has shown that
labeling and data are usually submitted with the intent of labeling for
the specific pest.
    During the SAP, one commenter asked why the common stink bug
species is missing from ``true bugs.'' (Ref. 36). In response, the
common stink bug is not a disease vector or otherwise a pest of
significant public health importance, and therefore EPA did not include
it as a test species in the TSD presented to the SAP. Since the ``true
bug'' claims have changed in this group, stink bugs are no longer
relevant to this group.
    Similarly, the SAP suggested that both the conenose and the kissing
bug be required test species. Both the kissing bug and the conenose bug
(Triatoma protracta and Triatoma sanguisuga, respectively) are in the
same genus and are both vectors of Chagas disease. Given these
similarities and to reduce the number of studies to be submitted, EPA