Rule2022-07963
Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 15, 2022
Effective
June 14, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 73 (Friday, April 15, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#a6cdc3cbcbc388d5c7d4c7e6c3d6c788c1c9d0"><span class="__cf_email__" data-cfemail="88e3ede5e5eda6fbe9fae9c8edf8e9a6efe7fe">[email protected]</span></a>.
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,
<bullet> 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.
<bullet> 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.
<bullet> 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:
<bullet> Codifies a new subpart R in 40 CFR part 158 entitled,
``Product Performance for Products Claiming Effectiveness Against
Invertebrate Pests;''
<bullet> 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
<bullet> 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 <bullet> Average impact per submitted
submitted. data package of $17,000.
Cost savings per registrant <bullet> Average annual impact per
submitting data packages. registrant of $5,500.
Annualized Cost Savings...... <bullet> $1 million at both 3% and 7%
discount rates.
<bullet> This projection assumes 60 data
packages submitted annually to the
Agency.
Qualitative Effects.......... <bullet> For registrants: Quicker label
changes, lower discovery costs, lower
barriers to innovation.
<bullet> 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
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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.
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Other Impacts
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Small Business Impacts....... <bullet> No significant impact on a
substantial number of small entities.
<bullet> Affected NAICS codes contain up
to 5,438 small entities.
No increased costs to small entities
expected, and cost savings may be
relatively larger for small firms who do
not have experience with the
registration process for invertebrate
pests of public health importance,
invertebrate wood destroying pests, and
invertebrate invasive pests.
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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:
<bullet> Composition of the proposed pesticide is such as to
warrant the proposed claims for it;
<bullet> Labeling for the proposed pesticide and other material
required to be submitted comply with the requirements of FIFRA;
<bullet> The proposed pesticide will perform its intended function
without unreasonable adverse effects on the environment; and
[[Page 22467]]
<bullet> 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 <a href="https://www.epa.gov/sites/production/files/2014-04/documents/pr2002-1.pdf">https://www.epa.gov/sites/production/files/2014-04/documents/pr2002-1.pdf</a> 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 <a href="https://www.epa.gov/pesticide-registration/prn-96-7-termiticide-labeling">https://www.epa.gov/pesticide-registration/prn-96-7-termiticide-labeling</a>
(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 <a href="https://doi.org/10.1603/EC11005">https://doi.org/10.1603/EC11005</a>.
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 <a href="https://aspcro.org/wp-content/uploads/2020/12/supdocStatementofPurposeTLRC20100829.pdf">https://aspcro.org/wp-content/uploads/2020/12/supdocStatementofPurposeTLRC20100829.pdf</a>.
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 <a href="http://www2.epa.gov/laws-regulations/laws-and-executive-orders">http://www2.epa.gov/laws-regulations/laws-and-executive-orders</a>.
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
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