Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests, 15362-15396 [2021-05137]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Proposed Rules]
[Pages 15362-15396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05137]



[[Page 15361]]

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

[[Page 15362]]


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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 https://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 https://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 protected].

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

[[Page 15363]]

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

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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.
------------------------------------------------------------------------

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 https://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

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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

[[Page 15366]]

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

[[Page 15367]]

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).

[[Page 15368]]

 
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

[[Page 15369]]

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

[[Page 15370]]

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

[[Page 15371]]

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.

[[Page 15372]]

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

[[Page 15373]]

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

[[Page 15374]]

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

[[Page 15375]]

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

[[Page 15376]]

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

[[Page 15377]]

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

[[Page 15378]]

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

[[Page 15379]]

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

[[Page 15380]]

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

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

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

VIII. Updates to Subparts U and V

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

[[Page 15381]]

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

IX. Impact of This Proposal on Future and Existing Registrations

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

X. Peer Review

A. Human Studies Review Board

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

[[Page 15382]]

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

B. FIFRA Scientific Advisory Panel

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

[[Page 15383]]

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

XI. Request for Comments

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

XII. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

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

[[Page 15384]]

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

XIII. FIFRA Review Requirements

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

XIV. Statutory and Executive Order Reviews

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

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

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

B. Paperwork Reduction Act (PRA)

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

[[Page 15385]]

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

C. Regulatory Flexibility Act (RFA)

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

D. Unfunded Mandates Reform Act (UMRA)

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

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have substantial direct effects on the states, on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government.

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

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

[[Page 15386]]

Order 13175 does not apply to this action.

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

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

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

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

I. National Technology Transfer Advancement Act (NTTAA)

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

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

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

Lists of Subjects in 40 CFR Part 158

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

Jane Nishida,
Acting Administrator.

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

PART 158--DATA REQUIREMENTS FOR PESTICIDES

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

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

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


Sec.  158.1  Purpose and scope.

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

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

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

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


Sec.  158.1700  General requirements.

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


Sec.  158.1701  Definitions.

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

[[Page 15387]]

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


Sec.  158.1703  Application categories.

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


Sec.  158.1704  Performance standards for data acceptability.

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


Sec.  158.1705  Test guidelines.

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


Sec.  158.1707  Data requirement modifications.

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

[[Page 15388]]

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


Sec.  158.1708  Invasive species claims.

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


Sec.  158.1709  Invertebrate disease vector claims.

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


Sec.  158.1710  Structural and wood-destroying pest claims.

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


Sec.  158.1712  Mites (excluding chiggers).

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

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

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


Sec.  158.1714  Chiggers.

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


Sec.  158.1718  Ticks.

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

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

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

[[Page 15389]]

Sec.  158.1722  Scorpions.

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


Sec.  158.1726  Spiders.

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

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

Sec.  158.1732  Centipedes.

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

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

Sec.  158.1736  Lice.

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

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

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


Sec.  158.1740  Fleas.

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

[[Page 15390]]



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

Sec.  158.1744  Cockroaches.

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

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

Sec.  158.1748  Keds, screwworms, and bot flies.

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

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

Sec.  158.1752  Filth flies.

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

[[Page 15391]]

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

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

Sec.  158.1756  Mosquitoes.

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

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

Sec.  158.1760  Biting flies.

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

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

[[Page 15392]]

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

Sec.  158.1768  Bed bugs.

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

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

Sec.  158.1772  Conenose bugs and kissing bugs.

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

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

Sec.  158.1776  Ants (excluding carpenter ants).

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

[[Page 15393]]



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

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


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

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

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

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


Sec.  158.1782  Carpenter ants.

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

[[Page 15394]]



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

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

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

Sec.  158.1784  Wood-destroying beetles.

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

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

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

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

Sec.  158.1786  Termites.

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

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

[[Page 15395]]

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

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

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

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


Sec.  158.2070  Biochemical pesticides product performance data 
requirements.

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


Sec.  158.2160  Microbial pesticides product performance data 
requirements.

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

[[Page 15396]]

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


Sec.  158.2200  Applicability.

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