Document ID: EPA-HQ-OPP-2020-0124-0075
Agency: epa
Document Type: Rule
Title: Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests
Posted Date: 2022-04-15T04:00Z

[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Rules and Regulations]
[Pages 22464-22484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07963]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 158

[EPA-HQ-OPP-2020-0124; FRL-5331-05-OCSPP]
RIN 2070-AJ49

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is codifying 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: This final rule is effective on June 14, 2022.

ADDRESSES: The EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2020-0124. All documents 
in the docket are listed on the https://www.regulations.gov website. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available electronically through https://www.regulations.gov.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Sara Kemme, Mission Support Division 
(7101M), Office of Program Support, Office of Chemical Safety and 
Pollution Prevention, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-1217; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Does this action apply to me?

    You 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 codifying 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-

[[Page 22465]]

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 
will inform the data needed to substantiate pesticidal claim(s) made on 
the label of the pesticide products. The 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 codifying 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 final 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. Applicants 
must submit studies demonstrating their product's efficacy using 
specified test species and meeting specified performance standards. 
Numerical performance standards, such as the percent mortality, percent 
repellency, percent knockdown, or complete protection time, will need 
to be achieved to deem the data acceptable for the purpose of 
supporting a product making a claim against an invertebrate pest. 
Codifying essential elements relating to test species and performance 
standards will provide the regulated community a better understanding 
of the data necessary to support registration of a product that claims 
efficacy against invertebrate pests.
    This final rule:
     Codifies a new subpart R in 40 CFR part 158 entitled, 
``Product Performance for Products Claiming Effectiveness Against 
Invertebrate Pests;''
     Renames 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 new subpart R; 
and
     Revises 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, this final rule updates 40 CFR 158.1(c) to insert 
references to the subparts to categorize them under the ``scope of the 
subparts'' section. EPA is also updating subpart W at 40 CFR 
158.2200(b) to insert a cross reference to the newly created subpart R 
to clarify the status of a product that bears both an antimicrobial 
claim and a non-antimicrobial claim against one of the pests specified 
in proposed subpart R.

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

    This action is issued under the authority of sections 3, 5, 10, 12, 
and 25 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) (7 U.S.C. 136-136y), as amended. Under FIFRA section 
3(c)(2)(A), EPA is required to specify ``the kinds of information which 
will be required to support the registration of a pesticide and shall 
revise such guidelines from time to time.'' EPA's codification of these 
data requirements is in 40 CFR part 158.
    Additionally, the Pesticide Registration Improvement Extension Act 
of 2018 (PRIA 4) (7 U.S.C. 136 note, 133 Stat. 484) was enacted into 
law on March 8, 2019. PRIA was developed by a coalition of pesticide 
stakeholders representing seven different trade groups within the 
pesticide industry and public interest groups reflecting the 
environmental and farmworker safety communities. The result of this 
collaboration is that there are elements of PRIA 4 important to all the 
represented stakeholder entities in the coalition. PRIA 4 specifically 
establishes a new maintenance fee set-aside of up to $500,000/year to 
develop and finalize rulemaking and guidance for product performance 
data requirements for certain invertebrate pests of significant public 
health or economic importance. Specific to this rule, PRIA 4 requires 
EPA to finalize product performance data requirements by September 30, 
2021, for certain pesticides intended for preventing, destroying, 
repelling, or mitigating specified invertebrate pest of significant 
public health or economic importance.
    This final 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 final rule covers some invertebrate pests in addition 
to those specified in PRIA 4 due to their public health, economic, or 
ecological significance (e.g., wood destroying insects).

D. Why is EPA taking this action?

    The following objectives were considered by EPA in developing this 
rule:
    1. Obtaining reliable data to make the statutory finding. The data 
submitted to EPA for review and evaluation as a result of this final 
rule 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. This final rule 
identifies the specific data requirements that apply to pesticides 
making claims against certain categories of invertebrate pests. As with 
the original design of 40 CFR part 158 in 1984, and continued in 2007, 
given the variations in pesticide chemistry, exposure, and hazard, this 
final rule 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 rulemaking, EPA prepared an economic 
analysis entitled, ``Cost Analysis of the Final Product Performance 
Rule'' (Ref. 1) which presents an economic 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 finalized 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 or ecological 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. This final rule codifies data

[[Page 22466]]

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 covered pests.
    This final rule clarifies data requirements and therefore improves 
efficiency and effective use of resources by both the Agency and 
industry. Moreover, this final rule will serve the public by ensuring 
that appropriate efficacy data are available to substantiate the label 
claims on these products. 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 final rule will 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 158.30, 
158.45 and 40 CFR 158.1707, on a case-by-case basis the Agency may 
consider alternative information and data that are more appropriate 
than the final rule requirements, considering the intended purpose and 
pesticidal claims of a pesticidal product.
    EPA estimates that this final rule will result in cost savings of 
one million dollars annually across all registrants seeking label 
claims against invertebrate pests of significant public health 
importance, wood-destroying insects, and invasive invertebrate pests, 
equivalent to about $17,000 in savings per data package submitted to 
the Agency (Table 1). The average savings per registrant is $5,500 
annually, considering that registrants do not submit products for 
review every year. This impact is expected to remain consistent over 
the next ten years, with total cost savings to industry of $1 million 
annually using either a 3% or a 7% discount rate. Over ten years, this 
amounts to about $8.5 million in savings at a 3% discount rate or about 
$7 million in savings at a 7% discount rate. The most expansive 
estimate of registrant cost savings of the final 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. 
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--Summary of Benefits and Costs of the Final Rule
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                   Expected Benefits of the Final 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 Final Rule
------------------------------------------------------------------------
No increased risk to human health or the environment is expected from
 publication of the final rule. No increased costs to registrants or
 consumers are expected from publication of the final rule. Expected
 direction of costs for the Agency from the final rule is unknown.
------------------------------------------------------------------------
                              Other Impacts
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

II. Background

    The proposed rule (86 FR 15362, March 22, 2021) (FRL-10011-06) 
provided detailed background information on the pesticide registration 
process, the preexisting regulatory framework, why product performance 
data matter, and the relationship between this rulemaking and other 
guidance documents (see proposed rule pages 15365-15368). This section 
briefly summarizes that information.

A. Statutory Background

    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

[[Page 22467]]

     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.'' This 
final rule identifies the data requirements EPA has determined are 
typically necessary to determine whether the proposed claims of 
efficacy are warranted, along with the opportunity for waiver or 
modifications pursuant to 40 CFR 158.30 and 158.45 and newly codified 
40 CFR 158.1707.

B. Registration Regulatory Framework

    FIFRA section 3 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).
    The pre-existing regulatory data requirements for product 
performance for pesticides are contained in 40 CFR part 158, subpart E, 
which for the most part is specific to vertebrates (e.g., birds, 
rodents, etc.); 40 CFR part 158, subpart U, section 158.2070, which is 
specific to biochemicals; 40 CFR, subpart V section 158.2160, which is 
specific to microbials; and 40 CFR part 158, subpart W, 158.2220, which 
is specific to 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. 
This rulemaking creates a new subpart R for invertebrate product 
performance requirements to capture the updates to the product 
performance data requirements for pesticides, and makes conforming 
edits to subparts E, U, V, and W.

C. Why does product performance matter?

    The primary goal of this final rule 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. 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, (Refs. 2 
and 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 or economic 
importance. The preamble to the proposed rule provides a more detailed 
discussion of the consequence of ineffective control of these pests 
(see proposed rule at page 15366).

D. 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 EPA's product 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.

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

    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.
    As a general matter, this final regulation describes the product 
performance data requirements, and the guidelines give examples of how 
to conduct studies to generate those data. 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.

III. The Scope of Subpart R

    The proposed rule provided a detailed discussion of EPA's rationale 
for the scope of the rule, including EPA's reasoning for including the 
specified pests, EPA's methods for selecting the representative test 
species, and the reasoning behind the performance standards. (See 
proposed rule at pg. 15386). This section provides a summary of that 
discussion. Unit VII. of the preamble to this final rule discusses 
public comments related to the scope of the final rule and EPA's 
response to those comments. EPA selected three pest categories for this 
rule: Pests of significant public health importance, wood-destroying 
insects, and invasive species. The rationale for selection of these 
three categories follows.

[[Page 22468]]

A. Categories of Pests Covered by This Regulation

    The invertebrate species of significant public health importance 
identified in this rule as requiring submission of product performance 
data are derived from the invertebrate pest list identified in PR 
Notice 2002-1, a draft update which was released for comment in 2020 
(Ref. 2). These invertebrate pests pose a threat of injury, disease 
transmission and/or pathogen transfer, and allergen production. They 
can have venomous bites or stings, and can vector serious diseases such 
as Rocky Mountain Spotted Fever, Lyme Disease, Ehrlichiosis, West Nile 
Virus, Dengue Fever, Malaria, Encephalitis, Yellow Fever, Chikungunya 
Fever, and Zika Virus.
    Structural pests differ from pests of significant public health 
importance because health of individuals is not imperiled. However, the 
effectiveness of the treatment is not readily apparent to the 
applicator at the time of application or during the occupancy of the 
building or home, and a potential for significant financial loss to the 
property owner exists. EPA has generally required submission of product 
performance data for wood-destroying insects for over 40 years. 
Similarly, invertebrate invasive species can impose serious economic 
costs by causing or vectoring diseases against native species that have 
little or no natural defenses. 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.
    As proposed, EPA is not codifying a comprehensive list of all the 
specific invasive species for which product performance data might be 
deemed necessary. Currently, EPA is codifying product performance data 
submission requirements only for the emerald ash borer and the Asian 
longhorned beetle. However, 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.

B. 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. 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 a claim against the general group or 
subgroup. 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.
    To develop the 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.

C. General Requirements

    The provisions at 40 CFR 158.1700 contain the general requirements 
that are applicable to any pesticide product that is making a claim(s) 
against an invertebrate pest, and describes how to use the data tables 
in 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.
    In order to ensure consistent implementation of subpart R, EPA is 
finalizing definitions specific to the subpart. The provisions at 40 
CFR 158.1701 and 158.1703 contain the definitions pertaining to subpart 
R. The provisions at 40 CFR 158.1704 codify 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. The provisions at 40 CFR 158.1705 
codify a reference to EPA's Harmonized Test Guidelines, which set forth 
a recommended approach to generate the data required for product 
performance testing. The provisions at 40 CFR 158.1707 state that on a 
case-by-case basis, the data requirements identified in subpart R may 
need to be modified 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. Pursuant to 40 CFR 158.30 and 158.45, EPA has 
historically taken the position that data requirements can be modified 
or waived on a case-by-case basis. The provision at 40 CFR 158.1707 is 
not intended to supersede or alter those provisions, but rather to 
provide that the data requirements, including the performance 
standards, in subpart R may be modified using the procedures consistent 
with those in 40 CFR 158.45. The provisions at 40 CFR 158.1709, state 
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.
    The provisions at 40 CFR 158.1710 state 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.

D. Pest-Specific Claims

    EPA is codifying product performance data submission requirements 
for pest groups, sub-groups, and some specific species. 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. 
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

[[Page 22469]]

laboratory testing, ubiquity, and whether they are one of the primary 
drivers of the human health concerns within a grouping. For pests that 
are not listed as a ``pest-specific claim'' in subpart R, the data 
required to support a group (or subgroup) claim would also be 
sufficient to support pest-specific claims for species within that 
group. Consistent with EPA's current practices, EPA has added a 
provision at 40 CFR 158.1700(4)(b) that makes clear that for a pest-
specific claim against any pest that is listed as a representative test 
species for a group or subgroup claim, pest-specific data would need to 
be submitted even if the pest is not listed in a subpart R provision 
explicitly requiring a pest-specific claim. For example, the American 
house dust mite (Dermatophagoides farinae) is listed as an option for 
testing for a claim against dust mites, and accordingly submission of 
data on the American house dust mite (Dermatophagoides farinae) would 
be needed for a pest-specific claim against American house dust mite 
(Dermatophagoides farinae). In contrast, the pavement ant (Tetramorium 
caespitum), for example, is not listed as a pest-specific claim nor is 
it a representative test species for a group or subgroup claim, thus it 
does not require submission of pest-specific data.
    As noted in the preamble to the proposed rule, the provisions at 40 
CFR 158.75 and 40 CFR 158.1708 would 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. 
Additionally, as proposed, EPA is finalizing provisions that would 
require group testing for mosquitos and ticks in order to make a claim 
against pests within those groups.

E. Data Requirements for Subpart R

    The data requirements that EPA is finalizing 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. The product performance data 
needs being finalized in this rule 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, as 
explained elsewhere, are waivable under 40 CFR 158.45.

IV. Response to Public Comments

    The 60-day public comment for the proposed rule closed on May 22, 
2021. EPA received 16 unique submissions to the docket. Commenters 
included trade associations (5), industry groups (4), consulting groups 
(2), state government associations (1), public interest groups (1), and 
private citizens (3). In this unit, EPA provides a summary of the major 
issues raised by commenters and EPA's responses, as well as summaries 
of public comments that prompted changes to the proposed requirements 
for the final rule. All public comments and EPA's responses to comments 
received, including those that do not raise significant issues or 
substantially change the proposed requirements, are included in 
Response to Comments document (Ref. 4) that is available in the docket 
for this rule.
    Commenters were supportive of the rulemaking. Their concerns were, 
in large part, focused and technical (e.g., add XXX pest, change XXX 
performance standard and/or related to uncertainty around rule 
implementation). EPA also received several comments that are outside 
the scope of the rule (e.g., related to testing guidelines). While EPA 
is finalizing this rule substantially as proposed, EPA is making some 
discrete changes to the rule in response to public comments. Those 
changes, and the reasons behind them, are discussed further in this 
Unit and in the Response to Comments Document.

A. Technical Comments

    EPA received several technical comments on the proposed regulation, 
including suggestions to add categories of claims, add or remove 
representative tests species, add additional definitions, and 
reevaluate the listed performance standards.
    One commenter suggested that EPA add a ``general flies'' claim to 
the regulations and that testing house fly, a tabanid sp., blow fly 
sp., and Fannia sp. would warrant this claim. After review of this 
comment EPA has determined that it is appropriate to add a general fly 
label claim category to the regulatory provisions. However, Tabanids 
have been included and little house flies have been excluded because of 
their relative size. Therefore, a general flies label claim would 
require testing of the following five species: (1) House fly (Musca 
domestica), AND (2) (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)), AND (3) Stable fly (Stomoxys 
calcitrans), AND (4) (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.)), AND (5) (Black horse fly (Tabanus 
atratus) OR Deer fly (Chrysops sp.) OR Striped horse fly (Tabanus 
lineola)). For readability, EPA is combining the sections on ``Filth 
flies'' and ``Biting flies'' into one section for ``Flies.''
    A commenter suggested adding an option to test the Arizona bark 
scorpion (Centrurioides sculpturatus) as an alternative to Centruroides 
vittatus. After review of the comment's suggestion, EPA agrees that the 
Arizona bark scorpion is more venomous and thus a greater health 
concern. EPA also agrees that it is a suitable alternative for testing 
for a claim against scorpions. Another comment recommended that EPA 
list Anopheles hermsi as a test species, because it is a closely 
related sibling species of Anopheles freeborni. EPA agrees with the 
commenter and is adding Anopheles hermsi as a testing option for the 
Anopheles genus. Accordingly, another scorpion (Centrurioides 
sculpturatus) and mosquito species (Anopheles hermsi) were added to the 
list of representative species options in 40 CFR 158.1722 and 40 CFR 
158. 1756.
    EPA received other comments suggesting changes to the 
representative test species, including requiring testing for only 
conenose or kissing bugs to receive a claim for both, allowing either 
the tropical or common bed bug as representatives for a general bed bug 
claim, substituting any recluse or widow spider as a representative 
species, adding Aedes taeniorhynchus as an additional option for 
testing the Aedes genus, including the lesser house fly as a 
representative species, and providing that Formosan subterranean 
termites are adequate for the entire group of ``subterranean termites. 
EPA is not adopting these suggestions because the Agency has determined 
that they do not provide adequate representation to support the claim 
or because the Agency does not have data to establish that they are 
adequate representatives. Please see the Response to Comments Document 
for more information on EPA's rationale for declining to adopt these 
suggestions.
    Commenters requested that EPA confirm that for products wishing to 
claim efficacy against a single species of termite, testing on that 
species alone would be adequate. EPA proposed provisions for mosquitoes 
and ticks that specifically required group testing for an

[[Page 22470]]

individual species claim because they are high stakes disease vectors 
and because consumers have difficulty differentiating between species. 
This has also been the Agency's general practice for termiticides 
because, due to the cryptic nature of subterranean termites, it is not 
possible for an applicator to know which species are present at the 
site of application. Visual confirmation of only one genus or species 
does not negate the possibility of the presence of another species at 
the time of application or during the period over which the treatment 
is intended to provide protection. For subterranean termites, EPA did 
not propose regulatory text provisions analogous to those propose for 
mosquitoes and ticks because EPA does not generally receive requests 
for claims against a single species of subterranean termite and because 
EPA would intend to continue its current practice even absent the 
regulatory change in those rare cases a request for such claims is 
submitted.
    In response to the comment submitted, however, EPA realizes that 
clear text in the provisions for ticks and mosquitoes may create 
confusion as to the data need in this context. As discussed in more 
detail in the Response to Comments document, no data have been provided 
to support the claim that Coptotermes formosanus is a more robust 
species and that products and application concentrations that are 
efficacious against C. formosanus are universally efficacious against 
the other subterranean termite species in the United States. (Refs. 5 & 
6). As a result, EPA has generally concluded that products claiming 
efficacy against subterranean termites must demonstrate efficacy 
against both genera and EPA has generally required--for structural 
protection and wood preservative claims against subterranean termites--
field testing in areas of the U.S. that have both Reticulitermes and 
Coptotermes species. (See, e.g., the guidance provided in OPPTS 
Guideline 810.3800 (Ref. 7); see also Ref. 8). For this reason, in 
response to comment, EPA has added a provision to the final regulatory 
text specifying that for the structural protection and wood 
preservative claim categories, a claim against any specific genus of 
subterranean termite must be supported by data on that individual genus 
and all the required test genera for a subterranean termite claim must 
be tested and submitted.
    A commenter raised concerns with the proposed terminology. The 
commenter suggested that ``Nonstructural: Wood Preservative Treatment'' 
be deleted and replaced with ``No Structural Protection'' and the 
definition of ``No Structural Protection'' be added to 158.1701. The 
terms ``Structural'' and ``non-structural'' are used in other facets of 
construction and should not be used as it will cause confusion. The 
commenter also suggested that in Table 2 to Paragraph (c) in sections 
158.1782, 158.1784 and 158.1786, the column heading ``Application 
Category'' be changed to ``Label Claim'' as the criteria in each table 
are really related to claims.
    In response to the concerns that the commenter raised, in addition 
to the definition of ``structural protection'' which was included in 
the proposal, EPA is adding a definition for ``wood protectants and 
other non-structural protection'' in Sec.  158.1703, Application 
categories. With respect to the comment that in Table 2 to Paragraph 
(c) in sections 158.1782, 158.1784 and 158.1786, EPA should change the 
column heading ``Application Category'' to ``Label Claim,'' EPA is 
changing the column heading to ``Claim Category'' and reorganizing the 
table to clearly identify non-structural wood-preservative claims and 
structural protection claims. EPA chose ``Claim Category'' instead of 
the commenter's suggestion of ``Label Claim'' because a bait treatment 
is an application method not a label claim.
    One commenter noted that EPA agreed with the SAP's conclusion that 
an across-the-board 95 percent standard was impractical, and EPA 
generally adjusted that standard to 90 percent, but kept the 95 and 100 
percent performance standards for certain pests, including carpenter 
ants, termites, wood-destroying beetles, human mites and lice, wood-
destroying pests, and non-structural wood preservative treatments. 
Commenters recommended lowering the standard to no higher than 90 
percent for all covered pests because the commenters believe biological 
variability, scientific probabilities, and testing artifacts can affect 
the outcome of a study, and it is still difficult or impossible to rely 
on a performance standard greater than 90 percent. One commenter 
believes that a higher standard could impede the development of new 
chemistries.
    As the commenter recognizes, for the majority of pests, EPA 
proposed and is finalizing in this rule a performance standard of 90 
percent. However, for the limited instances where EPA proposed and is 
finalizing in this rule a performance standard above 90 percent, there 
are countervailing reasons why the lower standard is not appropriate. 
In those cases, EPA has determined that proposed performance standards 
are both attainable and prudent. Registrants can and have been meeting 
these standards for years. The studies are conducted under highly 
controlled field and/or laboratory conditions. EPA notes that the 100 
percent performance standard for the dog follicle mite is to ensure a 
product works and should not require repeat treatment. Because dogs 
that show symptoms have a weakened immune system and would continue to 
show symptoms if the mites are not eliminated from the animal, the 100 
percent standard is appropriate for efficacy against this pest. 
Additionally, for products that are intended to provide structural 
protection of homes and other occupied structures or prevention of 
damage to wood that is a critical element of a structure (e.g., 
bridges), reducing the performance level could result in dangerous or 
financially ruinous damage. In the case of lice, complete eradication 
of the infestation is necessary to prevent reinfestation of the host by 
remaining insects.
    With respect to the concern that performance standards of greater 
than 90 percent limit the development of novel products, EPA notes that 
provisions in the regulations give the Agency the flexibility to modify 
the data requirements, where appropriate (see 40 CFR 158.1707). 
Pursuant to that provision, data requirements may, on a case-by-case 
basis, be modified by EPA in response to written 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. The procedures for requesting a modification under 40 
CFR 158.1707 are the same as the procedures for requesting a waiver 
under 40 CFR 158.45.
    One commenter wrote that in section 158.1786 ``Termites'' table 2 
the 95% claim being would be difficult to obtain, and the commenter 
questioned whether the table implies wood consumption would be the only 
measurement for termite trial performance standard. There are several 
types of termite trials such as direct mortality of individuals and 
structural protection field trials that typically use other performance 
standards. In response EPA wishes to clarify that the percentage damage 
to wood (i.e., consumption of wood) is the endpoint in Table 2, as 
measured across all replicates, not within each replicate. Structural 
protection claims do not have direct mortality endpoints. Direct 
mortality endpoints would be appropriate for products that are intended 
to kill termites at the time of

[[Page 22471]]

application, but do not provide structural protection.
    EPA also adjusted the final regulatory text for clarity and to 
correct omissions. The proposed regulatory text for 40 CFR 158.1780 
singled out colony claims for Vespula spp. as having a 100% performance 
standard. In this final rule, EPA is clarifying that the 100% 
performance standard for colony claims applies to 40 CFR 158.1780 
(bees, wasps, yellowjackets, and hornets) and that the reference to 
Vespula spp. was intended to be an example. Additionally, EPA has added 
provisions for colony claims and for claims for baits products and 
products involving outdoor use to the Carpenter Ants section (40 CFR 
158.1782). In the proposal those provisions were included only in the 
Ants section (40 CFR 158.1776), but they are also applicable to 
carpenter ants. These changes are consistent with EPA's current 
practices and data needs.

B. Comments on the Implementation of the Rule

    EPA received several comments and questions regarding how the 
Agency intends to implement the regulations. These comments included 
suggestions for a more defined process for covering invasive exotic 
species, questions about waivers or modifications of these data 
requirements, and questions about the status of existing pesticide 
products.
    A commenter requested a transparent process for the addition of 
invasive species, beyond the emerald ash borer and the Asian longhorned 
beetle, which are currently the only invasive invertebrate species 
proposed. The commenter also requested clarity on the entity that can 
add invasive species that would require the submission of product 
performance data to the Agency to support efficacy claims--specifically 
including registrants if third parties are involved. The Agency did not 
propose to codify a process whereby additional invasive exotic species 
are added to a defined list of species requiring submission of efficacy 
data. 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 to support registration of the pesticide 
product. 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.
    A pest's status as an invasive exotic species is just one factor 
that may warrant submission of product performance data so that EPA can 
make the requisite statutory findings under FIFRA. EPA does not 
anticipate requiring data for invasive exotic species solely because 
they are invasive exotic species. EPA anticipates requiring submission 
of data for invasive exotic species when they are likely to have 
significant ecological or economic impacts, or when EPA determines they 
are pests of significant health importance. As with the emerald ash 
borer and Asian longhorned beetle, whether the efficacy of the products 
can be determined at the time of application is one factor EPA takes 
into consideration when determining if submission of efficacy data is 
necessary to make the requisite findings under FIFRA.
    Commenters asked questions about the flexibilities included in the 
proposed rule and in part 158 generally. One commenter indicated that 
40 CFR 158.1700, which states ``[t]he 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'' gives the reviewer too much discretion to require 
additional data. First, notwithstanding the provisions that EPA is 
finalizing in this action, registrants are required to generate, and 
make available to the Agency on request, data to support all pests for 
which claims are made on the label. Moreover, the provision cited by 
the commenter is merely intended to echo currently existing provisions 
(see, e.g., 40 CFR 158.30, 158.400(d), footnote 1) and allow EPA to 
maintain the flexibility it needs to make the requisite scientific 
findings under FIFRA in the face of emerging pests. Conversely, the 
provisions at 40 CFR 158.1707 and 40 CFR 158.45 allow entities to 
request a modification of data requirements or a waiver from those 
requirements that they believe are not appropriate for the unique 
circumstances of their products. In those cases, EPA has the discretion 
to grant such a modification request or waiver when the modified or the 
existing data available would be sufficient to permit EPA to evaluate 
the potential of the product to cause unreasonable adverse effects to 
man or the environment.
    One commenter asks that EPA clarify the requirements of the rule as 
they pertain to existing pesticides. The commenter states that there 
are many situations in which the historical efficacy data for an 
existing EPA approved pesticide has been sufficient to reliably 
substantiate the claims of the pesticide's effectiveness, even when the 
data do not meet the testing methods and documentation proposed by the 
rule. Applying the provisions of the proposed rule retroactively to 
these existing pesticides would be unnecessary, creating a financial 
burden for the registrant and additional cost to the end-user without 
added benefit. One commenter disagrees that the proposed regulatory 
requirements are consistent with EPA's current practices for wood 
preservatives and pressure-treated wood products.
    While EPA has the authority to issue a data call-in (DCI) for a 
particular product, because the provisions of this rule reflect the 
longstanding data-needs of the Agency, EPA expects that the Agency 
already has the necessary data for most of existing pesticide products 
covered by this rule. EPA notes that as part of the economic analysis 
conducted in support of this rulemaking, EPA looked at a sampling of 
more than 30 data package submissions and did not find any that did not 
meet the requirements as encompassed by the rule, although EPA did find 
some that had submitted extra data beyond what this rule requires.

C. Comments Outside the Scope of This Rule

    EPA received several comments on documents that are outside the 
scope of the proposed rule, but nonetheless of interest to 
stakeholders. EPA received comments on Pesticide Registration Notice 
(PRN) 2002-1: List of Pests of Significant Public Health Importance and 
on topics covered by the Series 810--Product Performance Test 
Guidelines. EPA did not propose to modify these guidance documents and 
is not doing so in this final rule. Likewise, EPA is not establishing 
or revisiting a process whereby these guidance documents may be 
modified. Because the topics raised may be of interest to stakeholders, 
EPA is summarizing these comments and providing clarifying information 
on the scope of these documents and how they are related to the final 
regulatory provisions.
    One commenter stated that pests of public health significance will 
evolve over time and requests clarity on how

[[Page 22472]]

the list of pests of significant public health importance will be 
updated to include emerging public health pests. The commenter requests 
a clear process for reviewing and, if needed, updating the list at 
least every five years. The commenter states that the addition of pests 
of public health significance, should be a collaborative process with 
stakeholder engagement.
    PRN 2002-1: List of Pests of Significant Public Health Importance 
is a guidance document published in accordance with section 28(d) of 
FIFRA which requires the EPA in coordination with the United States 
Department of Health and Human Services (HHS) and United States 
Department of Agriculture (USDA), to identify pests of significant 
public health importance and, in coordination with the Public Health 
Service, to develop and implement programs to improve and facilitate 
the safe and necessary use of chemical, biological and other methods to 
combat and control such pests of public health importance. The contents 
of the list are both over inclusive and under inclusive of the types of 
pests covered by this rulemaking. The list covers non-invertebrate 
pests of significant publish health importance such a fungi, bacteria 
and mammalian pests; but the list does not cover the wood-destroying 
insects covered by this action. This list is intended to be a reference 
document, and inclusion on the list does not affect the regulatory 
status of any registration or application for registration of any 
pesticide product.
    Because the list itself is outside the scope of this action, EPA is 
not modifying the list or codifying a new process for modifying the 
list. EPA acknowledges that changes in pest pressures brought about by 
climate change or other factors may necessitate seeking product 
performance data during the registration process to address concerns 
about efficacy of pesticides for use against a pest not listed in the 
PRN or in this rule. EPA agrees that it may be appropriate to update 
the PRN and the rule to include these new pests over time. In fact, in 
2020, EPA solicited comment on updating the PRN for the first time in 
roughly twenty years (see proposed rule at page 70146) and the Agency 
is currently in the process of developing the final guidance revisions.
    Updates of PRNs are done in accordance with PRN 2003-3: Procedural 
Guidance for EPA's Office of Pesticide Programs Procedures Concerning 
the Development, Modification, and Implementation of Policy Guidance 
Documents. EPA's Office of Pesticide Programs (OPP) thinks that public 
involvement in the development of all types of policy guidance 
documents is useful. Therefore, OPP's general practice is to provide 
notice and an opportunity for public comment as early as practicable 
and appropriate in the development of all significant new pesticide 
policy guidance documents or significant modifications to such policy 
guidance documents.
    Several commenters raised issues on topics covered by the Series 
810--Product Performance Test Guidelines (e.g., time to mortality, use 
of field versus semi-field tests, which sex to use, adults versus 
juveniles, etc.) and one commenter requested that EPA adopt separate 
industry developed testing protocols for wood-destroying insects. EPA 
did not propose to modify these guidance documents or to adopt new 
testing protocols and is not doing so in this final rule. While EPA 
encourages the use of these test guidelines, their use is not mandated 
by these regulations.
    With respect to the comment that EPA should reference Wood 
Protection Association (AWPA) standards, EPA acknowledges that the 
National Technology Transfer Advancement Act (NTTAA) directs federal 
agencies to use technical standards developed or adopted by voluntary 
consensus standards bodies if compliance would not be inconsistent with 
applicable law or otherwise impracticable. However, part 158 was never 
intended to mandate specific testing protocols. The purpose of part 158 
is to describe the minimum data and information EPA typically requires. 
Part 158 ``does not include study protocols, methodology, or standards 
for conducting or reporting test results'' (40 CFR 158.1(b)(3)). EPA is 
not deviating for this longstanding structure for part 158 in this 
action.
    The OCSPP test guidelines serve as a compendium of accepted 
scientific methodologies for research intended to provide data to 
inform regulatory decisions under TSCA, FIFRA, and/or the FFDCA. These 
documents provide guidance for conducting appropriate tests, and are 
also used by EPA, the public, and the companies that are required to 
submit data under FIFRA. The methods described in these guidelines are 
strongly recommended for generating the data that are the subject of 
the guidelines, but EPA recognizes that departures may sometimes be 
appropriate. Applicants may propose alternatives to the protocols 
described in the OCSPP test guidelines, with supporting rationale. The 
Agency assesses such proposals and does, where appropriate, accept data 
generated from protocols that deviate from OCSPP guidelines. The 
applicants may submit a protocol of their own devising for Agency 
review prior to conducting the study, and such submission is subject to 
a PRIA fee.

V. 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. U.S. EPA. Cost Analysis of the Final Product Performance Rule, 
prepared by the Biological and Economic Analysis Division, Office of 
Pesticide Programs, available in docket: EPA-HQ-OPP-2020-0124.
2. U.S. 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. U.S. EPA. PRN 96-7 Termiticide Labeling, available at https://www.epa.gov/pesticide-registration/prn-96-7-termiticide-labeling 
(accessed March 13, 2020).
4. U.S. EPA. Pesticide Product Performance Data Requirements Rule 
Response to Comments Document, available in docket: EPA-HQ-OPP-2020-
0124.
5. U.S. EPA. Mao, Gregg Henderson, Clay W. Scherer. 2011. Toxicity 
of Seven Termiticides on the Formosan and Eastern Subterranean 
Termites, Journal of Economic Entomology, Volume 104(3) pp. 1002-
1008, available at https://doi.org/10.1603/EC11005.
6. Su, N.Y., and R.H. Scheffrahn. 1991. Laboratory Evaluation of Two 
Slow-acting Toxicants Against Formosan and Eastern Subterranean 
Termites (isoptera: Thinotermitidae). Journal of Economic 
Entomology, Volume 84 (1) pp. 170-175. doi: 10.1093/jee/84.1.170.
7. U.S. EPA. OPPTS Guideline 810.3800--Methods for Efficacy Testing 
of Termite Baits (August 2004).
8. Association of Structural Pest Control Regulatory Officials 
(ASPCRO) Termiticide Standards Committee, Termiticide Performance 
Standards, August 5, 2010; available at https://aspcro.org/wp-content/uploads/2020/12/supdocStatementofPurposeTLRC20100829.pdf.
9. U.S. EPA. Supporting Statement for an Information Collection 
Request (ICR) Rule-related ICR Amendment for Pesticide Product 
Performance Data

[[Page 22473]]

Requirements for Products Claiming Efficacy Against Certain 
Invertebrate Pests (EPA ICR No.: 0277.23; OMB Control No.; 2070-
0060).

VI. FIFRA Review Requirements

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

VII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.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 rule have been 
submitted to OMB for approval under the PRA, 44 U.S.C. 3501 et seq. The 
Information Collection Request (ICR) document prepared by EPA is 
assigned EPA ICR No. 0277.23 and OMB Control No.: 2070-0060 (Ref. 9). 
You can find a copy of the ICR in the docket for this rule, and it is 
briefly summarized here. The information collection requirements are 
not enforceable until OMB approves them.
    The information collection activities in this 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. 0277.23). As such, this ICR is 
intended to amend that existing ICR at the final rule stage, 
incorporating the information collection activities attributable to 
this 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 potential respondent 
groups: 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: Mandatory. These data must be 
submitted for the applicant to receive the desired pesticide 
registration or label claim. Authorizing legislation is contained in 
Section 3 of FIFRA (7 U.S.C. 136). The implementing regulations 
specific to the product performance data requirements are contained in 
40 CFR part 158.
    Estimated number of respondents: EPA estimates that registrants of 
products covered by this rule 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: This 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 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 supporting statement (Ref. 5), 
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 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 supporting statement (Ref. 5), $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. When OMB approves 
this ICR, the Agency will announce that approval in the Federal 
Register and publish a technical amendment to 40 CFR part 9 to display 
the OMB control number for the approved information collection 
activities contained in this final rule.

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, EPA concludes that the 
impact of concern for this rule is any significant adverse economic 
impact on small entities and that the Agency is certifying that this 
rule will not have a significant economic impact on a substantial 
number of small entities because the rule relieves regulatory burden on 
the small entities subject to the rule. EPA's small entity analysis 
suggests that the greatest impact, and the most potential cost savings, 
will 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 will 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 this rule will 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 
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

[[Page 22474]]

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, as defined by the 
RFA will experience cost savings each year as a result of this rule.
    While not every element of the rule will result in savings for 
registrants, EPA conservatively estimates that the rule will 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 this 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. This rule will 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 
rule is not subject to the requirements of UMRA sections 202, 203, or 
205. The cost analysis for this action is summarized in Unit I.E. and 
is available in the docket.

E. Executive Order 13132: Federalism

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

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

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

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

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

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

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

I. National Technology Transfer Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations and 
Executive Order 14008: Tackling the Climate Crisis at Home and Abroad

    In accordance with Executive Order 12898 (59 FR 7629, February 16, 
1994) and Executive Order 14008 (86 FR 7619, January 27, 2021), EPA 
finds that this action will not result in disproportionately high and 
adverse human health, environmental, climate-related, or other 
cumulative impacts on disadvantaged communities because this action 
does not establish an environmental health or safety standard. Rather, 
it codifies existing practices in terms of the efficacy data that EPA 
will typically need to register a product with a claim for one of the 
covered pests. The Agency notes, that the requirements in this final 
rule 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.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and the 
EPA will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a ``major 
rule'' as defined by 5 U.S.C. 804(2).

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.

Michael S. Regan,
Administrator.

    For the reasons set forth in the preamble, 40 CFR chapter I is 
amended 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.

[[Page 22475]]

    (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 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 Flies.
158.1756 Mosquitoes.
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.

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. For pests listed as part of a group or subgroup, 
pest-specific data would also need to be submitted to support a pest-
specific 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.
    Introduction means the intentional or unintentional escape, 
release, dissemination, or placement of a species into an ecosystem as 
a result of human activity.
    Invasive species means with respect to a particular ecosystem, any 
species that is not native to that ecosystem, and whose introduction 
does or is likely to cause economic or environmental harm or harm to 
human health.
    Performance standard means a benchmark or reference against which 
the efficacy of the pesticide is compared (including, but not limited 
to, the ability of the pesticide product to control, kill, or repel an 
invertebrate pest species).
    Pest group labeling claim means a claim or statement on the 
labeling of the pesticide product that the product is effective against 
a group of related species or taxa demonstrating adequate similarity in 
basic biology and life history characteristics to permit identification 
of representative test species for the entire assemblage of taxa.
    Pest-specific labeling claim means a claim or statement on the 
labeling of the pesticide product that the product is effective against 
a particular arthropod species, such as German cockroach or house fly.
    Pest sub-group labeling claim means a claim or statement on the 
labeling of the pesticide product that the product is effective against 
a set of related species or taxa demonstrating adequate similarity in 
basic biology and life history characteristics to permit identification 
of representative test species and part of a larger identified 
taxonomic grouping (e.g., Biting flies) that includes other pest 
species, which may or may not have a specified 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 a 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 breed 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.
    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.

[[Page 22476]]

    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.
    Wood protectants and other non-structural protection means the 
prevention of termite or other wood-destroying pest activity only to 
the treated wood (or other treated material), whereas structural 
protectants, however applied, claim to prevent damage to the structure.

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 158.1786, 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.  158.1712 through 
158.1786, a minimum performance standard of 90 percent is required, 
except skin-applied insect repellents as specified in paragraph (b) of 
this section, and non-wearable spatial repellents, where a minimum 
performance standard of 75 percent is required.

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 modified 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 in the same manner as waiver requests submitted under 40 CFR 
158.45. EPA will respond in writing to those requests. The Agency may 
grant the request if it finds such modifications are appropriate for 
the pesticide in question, and 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 test 
data conducted with the species specific to the disease vector claim 
and meeting the specific performance standard for that species is 
required even if the disease vector species is not the test species 
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 to 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).

[[Page 22477]]

 
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, the 
performance standard is 100 percent.
    (2) For the human itch or scabies mite, the performance standard is 
100 percent.

Sec.  158.1714   Chiggers.

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

Sec.  158.1718   Ticks.

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

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

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

Sec.  158.1722   Scorpions.

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

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 to Paragraph (b)--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).
------------------------------------------------------------------------

[[Page 22478]]

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

Sec.  158.1736   Lice.

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

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

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

Sec.  158.1740   Fleas.

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

  Table 1 to Paragraph (b)--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.
    (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

[[Page 22479]]

pest-specific label claims appear in the following table.

  Table 1 to Paragraph (b)--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 to Paragraph (b)--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   Flies.

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

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                           Claim Against Flies
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Flies.............................  Testing of five species is required:
                                    House fly (Musca domestica) AND
                                     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) AND
                                     Stable fly (Stomoxys calcitrans)
                                     AND 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.) AND Black
                                     horse fly (Tabanus atratus) OR Deer
                                     fly (Chrysops sp.) OR Striped horse
                                     fly (Tabanus lineola).
------------------------------------------------------------------------
                          Pest Sub-Group Claims
------------------------------------------------------------------------
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).
Biting flies (excluding Sand        Testing is required on three
 flies).                             species:
                                    Stable fly (Stomoxys calcitrans)

[[Page 22480]]

 
                                    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.).
Large Biting Flies................  Testing is required on two species:
                                    Stable fly (Stomoxys calcitrans).
                                    AND one of the following species:
                                    Black horse fly (Tabanus atratus) OR
                                     Deer fly (Chrysops sp.) OR Striped
                                     horse fly (Tabanus lineola).
Small Biting Flies (excluding Sand  Testing is required on one of the
 flies).                             following species:
                                    Biting midge (punkie, granny nipper,
                                     no-see-um) (Culicoides sp.) OR
                                     Black fly (Simulium sp. OR
                                     Prosimulium sp.) OR Black gnat
                                     (Leptoconops sp.).
------------------------------------------------------------------------
                          Pest-Specific Claims
------------------------------------------------------------------------
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).
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.  158.1756  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 to Paragraph (b)--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 hermsi OR Anopheles
                                     punctipennis OR Anopheles
                                     quadrimaculatus OR Anopheles
                                     stephensi.
------------------------------------------------------------------------

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.

[[Page 22481]]

  Table 1 to Paragraph (b)--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 to Paragraph (b)--Required Test Species for Products Making a
                 Claim Against 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.
    (b) 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. The group and sub-group claims 
in this paragraph are for direct kill and residual surface application 
claims against foraging ants only (excluding colony claims).

  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).
------------------------------------------------------------------------
                          Pest 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 for each 
species listed or each representative species, in the case of a group. 
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 or each 
representative species, in the case of a group.

[[Page 22482]]

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 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. The group and sub-group claims in this paragraph are 
for direct kill and residual surface application claims against 
foraging ants only (excluding colony claims).

  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 and in paragraphs (d) and (e)of this section. The 
performance standards for labeling claims not covered in this section 
appear in Sec.  158.1704.

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

    (d) Colony Claims. For colony claims, testing must be done for each 
species listed or each representative species, in the case of a group.
    (e) 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 or each 
representative species, in the case of a group.

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.

[[Page 22483]]

  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
------------------------------------------------------------------------
             Claim category                    Performance standard
------------------------------------------------------------------------
Non-Structural Protection: Wood          100% prevention of damage to
 Preservative Treatment.                  wood for >=2 years.
Structural Protection, except Baits....  95% prevention of damage to
                                          wood >=5 years.
Structural Protection: Bait Treatment..  95% prevention of damage to
                                          wood >=3 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. For the structural protection and wood preservative claim 
categories, a claim against any specific genus of subterranean termite 
must be supported by data on that individual genus and all the required 
test genera for a subterranean termite claim must be tested and 
submitted.

  Table 1 to Paragraph (b)--Required Test Species for Products Making a
                         Claim Against Termites
------------------------------------------------------------------------
          Labeling claim                    Required test species
------------------------------------------------------------------------
                            Pest Group Claim
------------------------------------------------------------------------
Termites..........................  Testing on species from four genera
                                     of termites is required:
                                    Testing is required on the following
                                     Coptotermes termite:
                                    Coptotermes formosanus AND one of
                                     the following Reticulitermes
                                     species:
                                    Reticulitermes flavipes OR
                                     Reticulitermes hesperus OR
                                     Reticulitermes virginicus AND one
                                     of the following arboreal termite
                                     species:
                                    Nasutitermes corniger 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 corniger.
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 formosanusAND 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
------------------------------------------------------------------------
             Claim category                    Performance standard
------------------------------------------------------------------------
Non-Structural Protection: Wood          100% prevention of damage to
 Preservative Treatment.                  wood for >=2 years.
Structural Protection, except Baits....  95% prevention of damage to
                                          wood >=5 years.
Structural Protection: Bait Treatment..  95% prevention of damage to
                                          wood >=3 years.
------------------------------------------------------------------------

[[Page 22484]]

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 and performance standards 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. However, data 
requirements and the performance standards that determine the 
acceptability of data may be waived or modified on a case-by-case basis 
pursuant to the waiver provisions in Sec.  158.45 and modification 
provisions in Sec.  158.1707.
    (c) Product performance data for each product that bears a public 
health pest 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 and the performance standards 
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 Sec.  158.45 and the provisions in Sec.  
158.1707.
    (c) Product performance data for each product that bears a public 
health pest claim, excluding those covered under paragraph (b). Product 
performance data must be submitted with any application for 
registration or amended registration, if the product bears a claim to 
control public health pests, such as pest microorganisms infectious to 
humans in any area of the inanimate environment, or a claim to control 
vertebrates, including but not limited to, rodents, birds, bats, 
canids, and skunks.
0
7. In Sec.  158.2200, revise paragraph (b) to read as follows:

Sec.  158.2200  Applicability.

* * * * *
    (b) A product that bears both antimicrobial and non-antimicrobial 
uses or claims is subject to the data requirements for pesticides in 
subparts C through O, R, and U or V of this part with respect to its 
non-antimicrobial uses and claims, and to the requirements of this 
subpart with respect to its antimicrobial uses and claims.
* * * * *

[FR Doc. 2022-07963 Filed 4-14-22; 8:45 am]
BILLING CODE 6560-50-P