22464 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Rules and Regulations 

Dated: April 11, 2022. 

Meghan A. McCollister, 

Regional Administrator, Region 7. 

For the reasons stated in the 

preamble, the EPA amends 40 CFR part 

52 as set forth below: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart Q—Iowa 

■ 2. In § 52.820, the table in paragraph 

(e) is amended by adding the entry 

‘‘(55)’’ in numerical order to read as 

follows: 

§ 52.820 Identification of plan. 

* * * * * 

(e) * * * 

EPA-APPROVED IOWA NONREGULATORY PROVISIONS

Name of non 

regulatory SIP 

provision 

Applicable 

geographic or nonattainment 

area 

State 

submittal 

date 

EPA approval date Explanation 

*******

(55) Transport SIP for 

the 2015 Ozone 

Standard.

Statewide ..................... 11/30/2018 April 15, 2022, [insert 

Federal Register citation].

[EPA–R07–OAR–2021–0870; EPA–HQ–OAR– 

2021–0663; FRL–9468–02–R7]. This transport SIP shows that Iowa does not significantly contribute to ozone nonattainment or 

maintenance in any other state. This submittal is approved as meeting the requirements of Clean Air Act section 

110(a)(2)(D)(i)(I). 

[FR Doc. 2022–08028 Filed 4–14–22; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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.), wooddestroying insects (e.g., termites), and 

certain invasive invertebrate species 

(e.g., Asian longhorned beetle). The 

latter two categories are pests 

considered to be of significant economic 

or ecological importance. Product 

performance data (efficacy studies) 

document how well the pesticide 

performs the intended function, such as 

killing or repelling, against an 

invertebrate pest. 

DATES: This final rule is effective on 

June 14, 2022. 

ADDRESSES: The EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2020–0124. All documents in the 

docket are listed on the https://

www.regulations.gov website. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available electronically 

through https://www.regulations.gov. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and Reading Room is 

open to visitors by appointment only. 

For the latest status information on 

EPA/DC services and docket access, 

visit https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Sara 

Kemme, Mission Support Division 

(7101M), Office of Program Support, 

Office of Chemical Safety and Pollution 

Prevention, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW, 

Washington, DC 20460–0001; telephone 

number: (202) 566–1217; email address: 

kemme.sara@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be affected by this action if 

you are a producer or registrant of 

pesticide products making claims 

against the specified categories of 

invertebrate pests. The North American 

Industrial Classification System 

(NAICS) codes are provided to assist 

you and others in determining if this 

action might apply to certain entities. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

regulated by this action. Other types of 

entities not listed could also be affected. 

Potentially affected entities may 

include, but are not limited to, 

• Chemical Producers (NAICS 32532), 

e.g., pesticide manufacturers or 

formulators of pesticide products, 

pesticide importers or any person or 

company who seeks to register a 

pesticide. 

• Research and Development in the 

Physical, Engineering, and Life Sciences 

(NAICS code 541712), e.g., research and 

development laboratories or services 

that perform efficacy testing for 

invertebrate pests. 

• Colleges, universities, and 

professional schools (NAICS code 

611310), e.g., establishments of higher 

learning which are engaged in 

development and marketing of products 

for invertebrate pest control. 

B. What action is the Agency taking? 

EPA is codifying product performance 

data requirements for pesticide products 

claiming efficacy against three 

categories of invertebrate pests: Those 

identified to be of significant public 

health importance (e.g., ticks, 

mosquitoes, cockroaches, etc.), woodVerDate Sep<11>2014 15:57 Apr 14, 2022 Jkt 256001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\15APR1.SGM 15APR1

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Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Rules and Regulations 22465 

destroying insects (e.g., termites), and 

certain invasive invertebrate species 

(e.g., Asian longhorned beetle). The 

latter two categories are considered to 

be of significant economic and/or 

ecological importance. 

Product performance data (efficacy 

studies) document how well the product 

performs the intended function, such as 

killing or repelling, against an 

invertebrate pest. The product 

performance data requirements will 

inform the data needed to substantiate 

pesticidal claim(s) made on the label of 

the pesticide products. The numerical 

performance standards specify the level 

of efficacy that would need to be 

achieved for EPA to deem the submitted 

data as acceptable for a product bearing 

the specified claim(s) against the 

invertebrate pest. For the most part, the 

data requirements that EPA is codifying 

are consistent with EPA’s current 

practices in data supporting 

applications for registration of a 

pesticide product that bears a pesticidal 

claim against one or more of these pests. 

This final rule presents the data 

requirements in tabular format. These 

tables link the efficacy claim on the 

label of a pesticide product with the 

data needed to substantiate that claim. 

Applicants must submit studies 

demonstrating their product’s efficacy 

using specified test species and meeting 

specified performance standards. 

Numerical performance standards, such 

as the percent mortality, percent 

repellency, percent knockdown, or 

complete protection time, will need to 

be achieved to deem the data acceptable 

for the purpose of supporting a product 

making a claim against an invertebrate 

pest. Codifying essential elements 

relating to test species and performance 

standards will provide the regulated 

community a better understanding of 

the data necessary to support 

registration of a product that claims 

efficacy against invertebrate pests. 

This final rule: 

• Codifies a new subpart R in 40 CFR 

part 158 entitled, ‘‘Product Performance 

for Products Claiming Effectiveness 

Against Invertebrate Pests;’’ 

• Renames 40 CFR part 158, subpart 

E to ‘‘Product Performance for Products 

Claiming Effectiveness Against 

Vertebrate Pests, Products with Prionrelated Claims, and Products for Control 

of Organisms Producing Mycotoxins’’ in 

order to add specificity to the title and 

reduce the potential for confusion with 

the new subpart R; and 

• Revises the data requirements for 

biochemicals in 40 CFR 158.2070 and 

microbials in 40 CFR 158.2160 to clarify 

the requirements for claims that would 

be subject to both subpart R and either 

subpart U or V. 

Additionally, this final rule updates 

40 CFR 158.1(c) to insert references to 

the subparts to categorize them under 

the ‘‘scope of the subparts’’ section. EPA 

is also updating subpart W at 40 CFR 

158.2200(b) to insert a cross reference to 

the newly created subpart R to clarify 

the status of a product that bears both 

an antimicrobial claim and a nonantimicrobial 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 


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22466 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Rules and Regulations 

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

Expected Benefits of the Final Rule 

Cost savings per data package submitted ......... • Average impact per submitted data package of $17,000. 

Cost savings per registrant submitting data 

packages.

• Average annual impact per registrant of $5,500. 

Annualized Cost Savings .................................... • $1 million at both 3% and 7% discount rates. 

• This projection assumes 60 data packages submitted annually to the Agency. 

Qualitative Effects ............................................... • For registrants: Quicker label changes, lower discovery costs, lower barriers to innovation. 

• For consumers: Ensuring product efficacy and label consistency; increased consumer confidence in product efficacy; reduced search costs for effective products; and reduction in 

damage from covered pests. 

Expected Costs of the Final Rule 

No increased risk to human health or the environment is expected from publication of the final rule. No increased costs to registrants or consumers are expected from publication of the final rule. Expected direction of costs for the Agency from the final rule is unknown. 

Other Impacts 

Small Business Impacts ..................................... • No significant impact on a substantial number of small entities. 

• Affected NAICS codes contain up to 5,438 small entities. 

No increased costs to small entities expected, and cost savings may be relatively larger for 

small firms who do not have experience with the registration process for invertebrate pests 

of public health importance, invertebrate wood destroying pests, and invertebrate invasive 

pests. 

II. Background 

The proposed rule (86 FR 15362, 

March 22, 2021) (FRL–10011–06) 

provided detailed background 

information on the pesticide registration 

process, the preexisting regulatory 

framework, why product performance 

data matter, and the relationship 

between this rulemaking and other 

guidance documents (see proposed rule 

pages 15365–15368). This section 

briefly summarizes that information. 

A. Statutory Background 

As a general matter, no person may 

distribute or sell an unregistered 

pesticide in the U.S. (FIFRA section 

3(a)). The process for obtaining a 

registration for a pesticide so that it may 

be distributed or sold begins with 

submission to EPA of an application 

with the necessary data to review the 

application request. Taking into account 

the information submitted, EPA must 

grant the requested registration, if it 

concludes, when considered with any 

restrictions imposed, that: 

• Composition of the proposed 

pesticide is such as to warrant the 

proposed claims for it; 

• Labeling for the proposed pesticide 

and other material required to be 

submitted comply with the 

requirements of FIFRA; 

• The proposed pesticide will 

perform its intended function without 

unreasonable adverse effects on the 

environment; and 


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• 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 caseby-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. 


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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 enduse 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 


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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-seeum) (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 


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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 § 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 woodpreservative 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 


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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 


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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 noninvertebrate pests of significant publish 

health importance such a fungi, bacteria 

and mammalian pests; but the list does 

not cover the wood-destroying insects 

covered by this action. This list is 

intended to be a reference document, 

and inclusion on the list does not affect 

the regulatory status of any registration 

or application for registration of any 

pesticide product. 

Because the list itself is outside the 

scope of this action, EPA is not 

modifying the list or codifying a new 

process for modifying the list. EPA 

acknowledges that changes in pest 

pressures brought about by climate 

change or other factors may necessitate 

seeking product performance data 

during the registration process to 

address concerns about efficacy of 

pesticides for use against a pest not 

listed in the PRN or in this rule. EPA 

agrees that it may be appropriate to 

update the PRN and the rule to include 

these new pests over time. In fact, in 

2020, EPA solicited comment on 

updating the PRN for the first time in 

roughly twenty years (see proposed rule 

at page 70146) and the Agency is 

currently in the process of developing 

the final guidance revisions. 

Updates of PRNs are done in 

accordance with PRN 2003–3: 

Procedural Guidance for EPA’s Office of 

Pesticide Programs Procedures 

Concerning the Development, 

Modification, and Implementation of 

Policy Guidance Documents. EPA’s 

Office of Pesticide Programs (OPP) 

thinks that public involvement in the 

development of all types of policy 

guidance documents is useful. 

Therefore, OPP’s general practice is to 

provide notice and an opportunity for 

public comment as early as practicable 

and appropriate in the development of 

all significant new pesticide policy 

guidance documents or significant 

modifications to such policy guidance 

documents. 

Several commenters raised issues on 

topics covered by the Series 810— 

Product Performance Test Guidelines 

(e.g., time to mortality, use of field 

versus semi-field tests, which sex to use, 

adults versus juveniles, etc.) and one 

commenter requested that EPA adopt 

separate industry developed testing 

protocols for wood-destroying insects. 

EPA did not propose to modify these 

guidance documents or to adopt new 

testing protocols and is not doing so in 

this final rule. While EPA encourages 

the use of these test guidelines, their use 

is not mandated by these regulations. 

With respect to the comment that EPA 

should reference Wood Protection 

Association (AWPA) standards, EPA 

acknowledges that the National 

Technology Transfer Advancement Act 

(NTTAA) directs federal agencies to use 

technical standards developed or 

adopted by voluntary consensus 

standards bodies if compliance would 

not be inconsistent with applicable law 

or otherwise impracticable. However, 

part 158 was never intended to mandate 

specific testing protocols. The purpose 

of part 158 is to describe the minimum 

data and information EPA typically 

requires. Part 158 ‘‘does not include 

study protocols, methodology, or 

standards for conducting or reporting 

test results’’ (40 CFR 158.1(b)(3)). EPA is 

not deviating for this longstanding 

structure for part 158 in this action. 

The OCSPP test guidelines serve as a 

compendium of accepted scientific 

methodologies for research intended to 

provide data to inform regulatory 

decisions under TSCA, FIFRA, and/or 

the FFDCA. These documents provide 

guidance for conducting appropriate 

tests, and are also used by EPA, the 

public, and the companies that are 

required to submit data under FIFRA. 

The methods described in these 

guidelines are strongly recommended 

for generating the data that are the 

subject of the guidelines, but EPA 

recognizes that departures may 

sometimes be appropriate. Applicants 

may propose alternatives to the 

protocols described in the OCSPP test 

guidelines, with supporting rationale. 

The Agency assesses such proposals and 

does, where appropriate, accept data 

generated from protocols that deviate 

from OCSPP guidelines. The applicants 

may submit a protocol of their own 

devising for Agency review prior to 

conducting the study, and such 

submission is subject to a PRIA fee. 

V. References 

The following is a listing of the 

documents that are specifically 

referenced in this document. The docket 

includes these documents and other 

information considered by EPA, 

including documents that are referenced 

within the documents that are included 

in the docket, even if the referenced 

document is not physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

1. U.S. EPA. Cost Analysis of the Final 

Product Performance Rule, prepared by 

the Biological and Economic Analysis 

Division, Office of Pesticide Programs, 

available in docket: EPA–HQ–OPP– 

2020–0124. 

2. U.S. EPA. Pesticide Registration (PR 

Notice) Notice 2002–1, available at 

https://www.epa.gov/sites/production/ 

files/2014-04/documents/pr2002-1.pdf at 

2 (accessed March 6, 2020); see also 

Public Review Draft: Pesticide 

Registration (PR Notice) 2020–[X], Draft 

List of Pests of Significant Public Health 

Importance—Revised 2020, docket EPA– 

HQ–OPP–2020–0260. 

3. U.S. EPA. PRN 96–7 Termiticide Labeling, 

available at https://www.epa.gov/ 

pesticide-registration/prn-96-7- 

termiticide-labeling (accessed March 13, 

2020). 

4. U.S. EPA. Pesticide Product Performance 

Data Requirements Rule Response to 

Comments Document, available in 

docket: EPA–HQ–OPP–2020–0124. 

5. U.S. EPA. Mao, Gregg Henderson, Clay W. 

Scherer. 2011. Toxicity of Seven 

Termiticides on the Formosan and 

Eastern Subterranean Termites, Journal 

of Economic Entomology, Volume 104(3) 

pp. 1002–1008, available at https://

doi.org/10.1603/EC11005. 

6. Su, N.Y., and R.H. Scheffrahn. 1991. 

Laboratory Evaluation of Two Slowacting Toxicants Against Formosan and 

Eastern Subterranean Termites (isoptera: 

Thinotermitidae). Journal of Economic 

Entomology, Volume 84 (1) pp. 170–175. 

doi: 10.1093/jee/84.1.170. 

7. U.S. EPA. OPPTS Guideline 810.3800— 

Methods for Efficacy Testing of Termite 

Baits (August 2004). 

8. Association of Structural Pest Control 

Regulatory Officials (ASPCRO) 

Termiticide Standards Committee, 

Termiticide Performance Standards, 

August 5, 2010; available at https://

aspcro.org/wp-content/uploads/2020/12/ 

supdocStatementofPurpose

TLRC20100829.pdf. 

9. U.S. EPA. Supporting Statement for an 

Information Collection Request (ICR) 

Rule-related ICR Amendment for 

Pesticide Product Performance Data 


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Requirements for Products Claiming 

Efficacy Against Certain Invertebrate 

Pests (EPA ICR No.: 0277.23; OMB 

Control No.; 2070–0060). 

VI. FIFRA Review Requirements 

Pursuant to FIFRA section 25(a), EPA 

submitted the draft final rule to the 

Secretary of Agriculture (USDA) and the 

FIFRA SAP for review. A draft of the 

final rule was also submitted to the 

appropriate Congressional Committees. 

VII. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulations 

and Regulatory Review 

This action is a significant regulatory 

action that was submitted to the Office 

of Management and Budget (OMB) for 

review under Executive Orders 12866 

(58 FR 51735, October 4, 1993) and 

13563 (76 FR 3821, January 21, 2011). 

Any changes made in response to OMB 

recommendations have been 

documented in the docket. EPA 

prepared an analysis of the potential 

costs and benefits associated with this 

action (Ref. 1) which is summarized in 

more detail in Unit I.E. This analysis is 

available in the docket. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this rule have been submitted to OMB 

for approval under the PRA, 44 U.S.C. 

3501 et seq. The Information Collection 

Request (ICR) document prepared by 

EPA is assigned EPA ICR No. 0277.23 

and OMB Control No.: 2070–0060 (Ref. 

9). You can find a copy of the ICR in the 

docket for this rule, and it is briefly 

summarized here. The information 

collection requirements are not 

enforceable until OMB approves them. 

The information collection activities 

in this rule are associated with the 

codification of efficacy data 

requirements against certain 

invertebrate pests. These information 

collection activities are activities 

associated with the application for a 

new or amended registration of a 

pesticide and are currently approved by 

OMB under OMB Control No. 2070– 

0060 (EPA ICR No. 0277.23). As such, 

this ICR is intended to amend that 

existing ICR at the final rule stage, 

incorporating the information collection 

activities attributable to this rule, 

including a reduction in transaction 

costs associated with a clear 

codification of the product performance 

data requirements for certain 

invertebrate pests. 

Respondents/affected entities: There 

are three potential respondent groups: 

Chemical producers (NAICS 32532); 

colleges, universities, and professional 

schools (NAICS code 611310); and 

research and development labs and 

services (NAICS code 541712). 

Respondent’s obligation to respond: 

Mandatory. These data must be 

submitted for the applicant to receive 

the desired pesticide registration or 

label claim. Authorizing legislation is 

contained in Section 3 of FIFRA (7 

U.S.C. 136). The implementing 

regulations specific to the product 

performance data requirements are 

contained in 40 CFR part 158. 

Estimated number of respondents: 

EPA estimates that registrants of 

products covered by this rule submit 60 

data packages to the Agency annually 

for efficacy review. Some registrants 

may submit multiple data packages per 

year. Under this rule the number of 

submissions may decline—and therefore 

the number of respondents may also 

decrease. 

Frequency of response: On occasion. 

Total estimated burden: This rule is 

expected to reduce burden hours by 

4,683 annually, including 4,515 hours 

from reduced paperwork burden 

associated with data generation and 168 

hours from reduced paperwork burden 

associated with the application process. 

Burden is defined at 5 CFR 1320.3(b). 

EPA already accounts for the activities 

associated with the rule in the currently 

approved ICR, which covers most 

activities associated with new and 

amended registrations; EPA estimates a 

total annual respondent burden of 1.5 

million hours for all these activities. As 

discussed in the supporting statement 

(Ref. 5), 483,000 of those hours are 

paperwork burden from data generation 

for new products, and 102,000 of those 

hours are paperwork burden from 

application for new and amended 

products. 

Total estimated cost: The estimated 

burden reduction is expected to reduce 

burden cost by $330,000 annually, 

including $315,000 from reduced 

paperwork burden associated with data 

generation and $15,000 from reduced 

paperwork burden associated with the 

application process, which includes $0 

annualized capital or operation and 

maintenance costs. EPA already 

accounts for the activities associated 

with the rule in the currently approved 

ICR, which covers most activities 

associated with new and amended 

registrations; EPA estimates a total 

annual respondent burden of $109 

million for all these activities. As 

discussed in the supporting statement 

(Ref. 5), $33.7 million of that cost is 

paperwork burden from data generation 

for new products, and $9.3 million of 

that cost is paperwork burden from 

application for new and amended 

products. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. The OMB control 

numbers for EPA’s regulations in 40 

CFR are listed in 40 CFR part 9. When 

OMB approves this ICR, the Agency will 

announce that approval in the Federal 

Register and publish a technical 

amendment to 40 CFR part 9 to display 

the OMB control number for the 

approved information collection 

activities contained in this final rule. 

C. Regulatory Flexibility Act (RFA) 

I certify that this action will not have 

a significant economic impact on a 

substantial number of small entities 

under the RFA, 5 U.S.C. 601 et seq. In 

making this determination, EPA 

concludes that the impact of concern for 

this rule is any significant adverse 

economic impact on small entities and 

that the Agency is certifying that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities because the 

rule relieves regulatory burden on the 

small entities subject to the rule. EPA’s 

small entity analysis suggests that the 

greatest impact, and the most potential 

cost savings, will accrue to small 

entities and new registrants. While large 

established registrants have experience 

with the registration process and are 

aware of EPA’s data requirements or 

have the means to determine the 

appropriate studies, new and small 

registrants without that experience may 

bear significant costs of acquiring this 

information. The registrants will have 

easier access to the data requirements, 

and the reduction in information 

acquisition costs would be largest for 

those registrants with the greatest 

information acquisition needs. Thus, 

EPA anticipates that this rule will result 

in cost savings, particularly for small 

and first-time registrants. While the 

affected NAICS codes contain up to 

5,438 small entities, EPA does not 

expect all entities to experience cost 

savings in all years as a result of this 

rule. As the cost analysis (Ref. 1) 

describes, a sample of 30 applications 

was selected at random. These 

applications were submitted by 16 

different firms, four of which EPA was 

able to identify as small businesses 

according to the Small Business 


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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, climaterelated, 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 lowincome 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 

■ 1. The authority citation for part 158 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; 21 U.S.C. 

346a. 

■ 2. In § 158.1, revise paragraph (c) to 

read as follows: 

§ 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. 


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(4) Antimicrobial pesticides. Subparts 

A, B, C, D, E, R, and W of this part apply 

to antimicrobial pesticides. 

■ 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 

■ 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. 

§ 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. 

§ 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 hostseeking 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. 

§ 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. 


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Structural protection means the 

prevention of termite or other wooddestroying pest activity in an entire 

structure as the result of an application 

of a pesticide product. 

Wood protectants and other nonstructural protection means the 

prevention of termite or other wooddestroying pest activity only to the 

treated wood (or other treated material), 

whereas structural protectants, however 

applied, claim to prevent damage to the 

structure. 

§ 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 

§§ 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 

§§ 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 nonwearable spatial repellents, where a 

minimum performance standard of 75 

percent is required. 

§ 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. 

§ 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. 

§ 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. 

§ 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 §§ 158.1712 through 

158.1786. 

§ 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 wooddestroying pest not identified in 

§§ 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. 

§ 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). 


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TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST MITES—Continued 

[Excluding chiggers] 

Labeling claim Required test species 

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. 

§ 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). 

§ 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 § 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). 

§ 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). 

§ 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). 


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TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST SPIDERS—Continued 

Labeling claim Required test species 

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). 

§ 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. 

§ 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. 

§ 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). 

§ 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 


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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). 

§ 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 fly) Testing is required on one of the 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). 

§ 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 flies) .... Testing is required on three species: 

Stable fly (Stomoxys calcitrans) 


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TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST FLIES—Continued 

Labeling claim Required test species 

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 

flies).

Testing is required on one of the 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 nipper, no-see-um).Biting midge (punkie, granny nipper, 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). 

§ 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 § 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. 

§ 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. 


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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). 

§ 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). 

§ 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. 


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§ 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 

Hornets.

Testing on three species is 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%. 

§ 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 § 158.1704. 

TABLE 2 TO PARAGRAPH (c)—PERFORMANCE STANDARDS FOR CERTAIN CLAIMS AGAINST CARPENTER ANTS

Claim category Performance standard 

Non-Structural Protection: Wood 

Preservative Treatment.

100% prevention of damage to 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. 

(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. 

§ 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. 


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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 

beetles.

Testing on three species is 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 § 158.1704. 

TABLE 2 TO PARAGRAPH (c)—PERFORMANCE STANDARDS FOR CERTAIN CLAIMS AGAINST WOOD-DESTROYING BEETLES

Claim category Performance standard 

Non-Structural Protection: Wood Preservative Treatment ....................... 100% prevention of damage to 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. 

§ 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 

Formosan Subterranean Termites.

Testing in two genera of termites is 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 § 158.1704. 

TABLE 2 TO PARAGRAPH (c)—PERFORMANCE STANDARDS FOR CERTAIN CLAIMS AGAINST TERMITES

Claim category Performance standard 

Non-Structural Protection: Wood Preservative Treatment ....................... 100% prevention of damage to 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. 


jspears on DSK121TN23PROD with RULES1
22484 Federal Register / Vol. 87, No. 73 / Friday, April 15, 2022 / Rules and Regulations 

■ 5. Revise § 158.2070 to read as 

follows: 

§ 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 

§ 158.45 and modification provisions in 

§ 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. 

■ 6. Revise § 158.2160 to read as 

follows: 

§ 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 § 158.45 and the 

provisions in § 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. 

■ 7. In § 158.2200, revise paragraph (b) 

to read as follows: 

§ 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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 217 

[Docket No. 220407–0086] 

RIN 0648–BJ87 

Takes of Marine Mammals Incidental to 

Specified Activities; Taking Marine 

Mammals Incidental to Lighthouse 

Repair and Tour Operations at 

Northwest Seal Rock, California 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule; notification of 

issuance. 

SUMMARY: NMFS Office of Protected 

Resources, upon request from the St. 

George Reef Lighthouse Preservation 

Society (Society), hereby issues 

regulations to govern the unintentional 

taking of marine mammals incidental to 

conducting aircraft operations, 

lighthouse renovation, light 

maintenance activities, and tour 

operations on the St. George Reef 

Lighthouse Station (Station) on 

Northwest Seal Rock (NWSR) over the 

course of five years (2022–2027). These 

regulations, which allow for the 

issuance of Letters of Authorization 

(LOA) for the incidental take of marine 

mammals during the described activities 

and specified timeframes, prescribe the 

permissible methods of taking and other 

means of effecting the least practicable 

adverse impact on marine mammal 

species or stocks and their habitat, as 

well as requirements pertaining to the 

monitoring and reporting of such taking. 

We are also issuing a Letter of 

Authorization to cover the first year of 

these activities. 

DATES: Effective from May 15, 2022 

through May 14, 2027. 

FOR FURTHER INFORMATION CONTACT: 

Amy Fowler, Office of Protected 

Resources, NMFS, (301) 427–8401. 

Electronic copies of the application and 

supporting documents, as well as a list 

of the references cited in this document, 

may be obtained online at: https://

www.fisheries.noaa.gov/permit/ 

incidental-take-authorizations-undermarine-mammal-protection-act. In case 

of problems accessing these documents, 

please call the contact listed above. 

SUPPLEMENTARY INFORMATION: 

Purpose and Need for Regulatory 

Action 

This final rule establishes a 

framework under the authority of the 

MMPA (16 U.S.C. 1361 et seq.) to allow 

for the authorization of take of marine 

mammals incidental to the Society 

conducting aircraft operations, 

lighthouse renovation, light 

maintenance activities, and tour 

operations on the Station on NWSR 

approximately 8 miles (12.9 km) 

northwest of Crescent City, CA. 

We received an application from the 

Society requesting 5-year regulations 

and authorization to take multiple 

species of marine mammals. Take 

would occur by Level B harassment 

incidental to acoustic and visual 

disturbance of pinnipeds during 

helicopter operations, lighthouse repair, 

and tour operations. Please see 

Background section below for 

definitions of harassment. 


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