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

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15362 Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Proposed Rules

ENVIRONMENTAL PROTECTION Environmental Protection Agency, 1200 The proposed numerical performance AGENCY Pennsylvania Ave. NW, Washington, DC standards specify the level of efficacy 20460–0001; telephone number: (703) that would need to be achieved for EPA 40 CFR Part 158 347–8533; email address: kemme.sara@ to deem the submitted data as [EPA–HQ–OPP–2020–0124; FRL–10011–06] epa.gov. acceptable for a product bearing the SUPPLEMENTARY INFORMATION: specified claim(s) against the RIN 2070–AJ49 invertebrate pest. For the most part, the I. Executive Summary data requirements that EPA is proposing Pesticide Product Performance Data A. Does this action apply to me? for codification are consistent with Requirements for Products Claiming EPA’s current practices in data Efficacy Against Certain Invertebrate You potentially may be affected by supporting applications for registration Pests this action if you are a producer or of a pesticide product that bears a registrant of pesticide products making pesticidal claim against one or more of AGENCY: Environmental Protection claims against the specified categories of Agency (EPA). these pests. invertebrate pests. The North American This proposed rule presents the data ACTION: Proposed rule. Industrial Classification System requirements in tabular format. These SUMMARY: The Environmental Protection (NAICS) codes are provided to assist tables link the efficacy claim on the Agency (EPA) is proposing to codify you and others in determining if this label of a pesticide product with the product performance data requirements action might apply to certain entities. data needed to substantiate that claim. to support registration of pesticidal This listing is not intended to be EPA is proposing that the studies products claiming efficacy against three exhaustive, but rather provides a guide submitted by an applicant demonstrate categories of invertebrate pests: Those for readers regarding entities likely to be the product’s efficacy in studies using identified to be of significant public regulated by this action. Other types of specified test species and with results health importance (e.g., ticks, entities not listed could also be affected. demonstrating that the product achieved mosquitoes, cockroaches, etc.), wood- Potentially affected entities may a specified level of performance, called include, but are not limited to, a performance standard. Numerical destroying insects (e.g., termites), and • certain invasive invertebrate species Chemical Producers (NAICS 32532), performance standards, such as the (e.g., Asian longhorned beetle). The e.g., pesticide manufacturers or percent mortality, percent repellency, latter two categories are pests formulators of pesticide products, percent knockdown, or complete considered to be of significant economic pesticide importers or any person or protection time would need to be or ecological importance. Product company who seeks to register a achieved to deem the data acceptable for performance data (efficacy studies) pesticide. the purpose of supporting a product • Research and Development in the document how well the pesticide making a claim against an invertebrate Physical, Engineering, and Life Sciences performs the intended function, such as pest. The Agency believes that codifying (NAICS code 541712), e.g., research and killing or repelling, against an essential elements relating to test development laboratories or services invertebrate pest. species and performance standards will that perform efficacy testing for provide the regulated community a DATES: Comments must be received on invertebrate pests. or before May 21, 2021. better understanding of the data EPA • Colleges, universities, and believes to be necessary to support ADDRESSES: Submit your comments, professional schools (NAICS code registration of a product that claims identified by docket identification (ID) 611310), e.g., establishments of higher efficacy against invertebrate pests. number EPA–HQ–OPP–2020–0124, learning which are engaged in EPA is proposing to: through the Federal eRulemaking Portal development and marketing of products • Codify a new subpart R in 40 CFR at http://www.regulations.gov. Follow for invertebrate pest control. part 158 entitled, ‘‘Product Performance the online instructions for submitting B. What action is the Agency taking? for Products Claiming Effectiveness comments. Do not submit electronically Against Invertebrate Pests;’’ any information you consider to be EPA is proposing to codify product • Rename 40 CFR part 158, subpart E Confidential Business Information (CBI) performance data requirements for to ‘‘Product Performance for Products or other information whose disclosure is pesticide products claiming efficacy Claiming Effectiveness Against restricted by statute. To make special against three categories of invertebrate Vertebrate Pests, Products with Prion- arrangements for hand delivery or pests: Those identified to be of related Claims, and Products for Control delivery of boxed information, please significant public health importance of Organisms Producing Mycotoxins’’ in follow the instructions at http:// (e.g., ticks, mosquitoes, cockroaches, order to add specificity to the title and www.epa.gov/dockets/contacts.html. etc.), wood-destroying insects (e.g., reduce the potential for confusion with Please note that due to the public termites), and certain invasive the proposed subpart R; and health emergency the EPA Docket invertebrate species (e.g., Asian • Revise the data requirements for Center (EPA/DC) and Reading Room longhorned beetle). The latter two biochemicals in 40 CFR 158.2070 and was closed to public visitors on March categories are considered to be of microbials in 40 CFR 158.2160 to clarify 31, 2020. Our EPA/DC staff will significant economic and/or ecological the requirements for claims that would continue to provide customer service importance. be subject to both subpart R and either via email, phone, and webform. For Product performance data (efficacy subpart U or V. further information on EPA/DC services, studies) document how well the product Additionally, EPA proposes to update docket contact information and the performs the intended function, such as 40 CFR 158.1(c) to insert references to current status of the EPA/DC and killing or repelling, against an the subparts to categorize them under Reading Room, please visit https:// invertebrate pest. The product the ‘‘scope of the subparts’’ section. EPA www.epa.gov/dockets. performance data requirements being is also proposing to update subpart W FOR FURTHER INFORMATION CONTACT: Sara proposed would inform the data needed at 40 CFR 158.2200(b) to insert a cross Kemme, Mission Support Division to substantiate pesticidal claim(s) made reference to the proposed subpart R to (7101M), Office of Program Support, on the label of the pesticide products. clarify the status of a product that bears

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both an antimicrobial claim and a non- D. Why is EPA taking this action? too slowly to remove ineffective antimicrobial claim against one of the The following objectives were products. The proposal, once final, pests specified in proposed subpart R. considered by EPA in developing this would codify data requirements for proposed rule: support of label claims that have, to C. What is EPA’s authority for taking date, been necessary, as determined on this action? 1. Obtaining reliable data to make the statutory finding. The data submitted to a case-by-case basis, to conduct This action is issued under the EPA for review and evaluation as a assessments of product performance. authority of sections 3, 5, 10, 12, and 25 result of this rule, once final, are This will provide needed clarity to firms of the Federal Insecticide, Fungicide, expected to improve the Agency’s seeking to develop and market products to control invertebrate pests of public and Rodenticide Act (FIFRA) (7 U.S.C. understanding of the effectiveness of health importance, invertebrate wood 136–136y), as amended. Under FIFRA pesticides that make claims against destroying pests, and invertebrate section 3(c)(2)(A), EPA is required to pests of public health or significant invasive pests. specify ‘‘the kinds of information which economic importance. This rule, when finalized, will clarify will be required to support the 2. Provide clear and transparent data data requirements and therefore registration of a pesticide and shall requirements. Once final, the regulatory improve efficiency and effective use of revise such guidelines from time to text proposed in this rule is intended to resources by both the Agency and time.’’ EPA’s codification of these data identify the specific data requirements industry. Moreover, this rule-making requirements is in 40 CFR part 158. that apply to pesticides making claims measure will serve the public by Additionally, the Pesticide against certain categories of invertebrate ensuring that appropriate efficacy data Registration Improvement Extension Act pests. As with the original design of part are available to substantiate public of 2018 (PRIA 4) (7 U.S.C. 136 note, 133 158 in 1984, and continued in 2007, health pest claims. While experience given the variations in pesticide Stat. 484) was enacted into law on over time has led to a fairly chemistry, exposure, and hazard, this March 8, 2019. PRIA was developed by standardized set of data requirements proposal for product performance data a coalition of pesticide stakeholders for invertebrate pests of significant requirements is intended to be clear and representing seven different trade public health importance, wood- transparent while retaining sufficient groups within the pesticide industry destroying insects, and invasive pests, flexibility to account for special and public interest groups reflecting the codifying these data needs will ensure circumstances. environmental and farmworker safety that new entrants to the field are clear communities. The result of this E. What are the estimated incremental about the information necessary to collaboration is that there are elements impacts? support registration. As a result, this of PRIA 4 important to all the rule, when finalized, would help In conjunction with this proposed alleviate uncertainties in the regulatory represented stakeholder entities in the rulemaking, EPA prepared an economic coalition. PRIA 4 specifically establishes process and enhance transparency for analysis entitled, ‘‘Cost Analysis of the stakeholders. The Agency is specifying a new maintenance fee set-aside of up Proposed Product Performance Rule’’ to $500,000/year to develop and finalize data requirements for invertebrate pests (Ref. 1) which presents an analysis of of significant public health importance, rulemaking and guidance for product the effects of codifying data performance data requirements for wood-destroying insects, and invasive requirements for product performance, invertebrate pests to better indicate certain invertebrate pests of significant as well as the effects of changes to label public health or economic importance. when certain data are needed or not. claim data requirements published Consistent with 40 CFR 158.45 and Specific to this rule, PRIA 4 requires simultaneously. EPA to finalize product performance proposed 40 CFR 158.1707, on a case- As noted previously, FIFRA mandates by-case basis the Agency may consider data requirements by September 30, the Agency to register pesticides, 2021. Specifically, the Act states that, alternative data that are more including those used against appropriate than the proposed ‘‘The Administrator shall, not later than invertebrate pests of public health September 30, 2021, issue regulations requirements considering the intended importance, invertebrate wood purpose and pesticidal claims of a prescribing product performance data destroying pests, and invasive requirements for any pesticide intended pesticidal product. invertebrate pests, under conditions of EPA estimates that the proposed rule for preventing, destroying, repelling, or use such that the pesticide is of a would result in cost savings of one mitigating any invertebrate pest of composition to warrant the proposed million dollars annually across all significant public health or economic claims. To make this finding, the registrants seeking label claims against importance specified in clauses (i) Agency requires that registrants submit invertebrate pests of significant public through (iv) of paragraph (B) [bed bugs; data demonstrating product efficacy health importance, wood-destroying premise (including crawling insects, against invertebrate pests of public insects, and invasive invertebrate pests, flying insects, and baits), pests of pets health importance, invertebrate wood equivalent to about $17,000 in savings (including pet pests controlled by spot- destroying pests, and invasive per data package submitted to the ons, collars, shampoos, powders, or invertebrate pests. The product Agency (Table 1). The average savings dips), and fire ants].’’ performance data requirements per registrant is $5,500 annually, This proposed rule includes product historically sought by the EPA and those considering that registrants do not performance data requirements for the being proposed in the rule are for claims submit products for review every year. categories of invertebrate pests specified against pests that either pose a threat to This impact is expected to remain in PRIA 4 and, thus, is intended to human health (e.g., mosquitoes and consistent over the next ten years, with satisfy the aforementioned rulemaking cockroaches) or have significant total cost savings to industry of $1 requirement. EPA notes that this economic impacts, against which the million annually using either a 3% or a proposed rule covers some invertebrate efficacy of a pesticide cannot be readily 7% discount rate. Over ten years, this pests in addition to those specified in determined by the user (e.g., termites amounts to about $8.5 million in PRIA 4 due to their public health, and emerald ash borers). In those savings at a 3% discount rate or about economic, or ecological significance. situations, market forces may operate $7 million in savings at a 7% discount

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

TABLE 1—BENEFITS AND COSTS OF THE PROPOSED RULE

Expected Benefits of the Proposed Rule

Cost savings per data package submitted ...... • Average impact per submitted data package of $17,000. Cost savings per registrant submitting data • Average annual impact per registrant of $5,500. packages. 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 Proposed Rule

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

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.

F. What should I consider as I prepare pesticide in the U.S. (FIFRA section pesticide’s composition is such as to my comments for EPA? 3(a)). The process for obtaining a warrant proposed claims of efficacy.’’ 1. Submitting Confidential Business registration for a pesticide so that it may The proposed regulations identify the Information (CBI). Do not submit this be distributed or sold begins with data requirements EPA believes are information to EPA through submission to EPA of an application necessary to determine whether the regulations.gov or email. Clearly mark with the necessary data to review the proposed claims of efficacy are the part or all of the information that application request. Taking into account warranted, the opportunity for waiver is you claim to be CBI. For CBI the information submitted, EPA must covered by 40 CFR 158.45 and proposed information in a disk or CD–ROM that grant the requested registration, if it 40 CFR 158.1707. you mail to EPA, mark the outside of the concludes, when considered with any EPA notes that ‘‘unreasonable adverse disk or CD–ROM as CBI and then restrictions imposed, that: effects on the environment’’ means ‘‘any • identify electronically within the disk or Composition of the proposed unreasonable risk to man or the CD–ROM the specific information that pesticide is such as to warrant the environment, taking into account the is claimed as CBI. In addition to one proposed claims for it; economic, social, and environmental • complete version of the comment that Labeling for the proposed pesticide costs, and benefits of the use of any includes information claimed as CBI, a and other material required to be pesticide . . .’’ as described in FIFRA copy of the comment that does not submitted comply with the section 2(bb). That definition was contain the information claimed as CBI requirements of FIFRA; amended in 1998 as part of the Food • must be submitted for inclusion in the The proposed pesticide will Quality Protection Act, requiring EPA to public docket. Information so marked perform its intended function without consider ‘‘the risks and benefits of will not be disclosed except in unreasonable adverse effects on the public health pesticide separate from accordance with procedures set forth in environment; and the risks and benefits of other • 40 CFR part 2. When used in accordance with pesticides. In weighing any regulatory 2. Tips for preparing your comments. widespread and commonly recognized action concerning a public health When preparing and submitting your practice, the proposed pesticide will not pesticide under this Act, the comments, see the commenting tips at generally cause unreasonable adverse administrator shall weigh any risks of http://www.epa.gov/dockets/ effects on the environment. the pesticide against the health risks comments.html. FIFRA section 3(c)(5) further provides such as the disease transmitted by the that EPA ‘‘may waive data requirements vector to be controlled by the II. Statutory Framework pertaining to efficacy, in which event pesticide.’’ While this rule proposes to As a general matter, no person may the Administrator may register the codify product performance data distribute or sell an unregistered pesticide without determining that the requirements for invertebrate pests of

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significant public health importance, over time. The registration review performance data requirements for (Ref. 2) this rule does not address program was implemented via a biochemical and microbial pesticides in classification of pesticides as ‘‘public regulation promulgated on August 9, 40 CFR 158.2070 and 158.2160, subparts health pesticides’’ as that term is 2006 (71 FR 45719) (FRL–8080–4). U and V, respectively (72 FR 60934, defined in FIFRA section 3(nn). The Therefore, starting in 2006, registration October 26, 2007) (FRL–8106–5). That data requirements proposed in this rule review began to replace EPA’s final rule adopted the requirement for will be used to make appropriate reregistration program as the applicants to submit product determinations under the FIFRA mechanism for systematic review of performance data to support registration ‘‘unreasonable adverse effects’’ existing pesticides. The registration of biochemical and microbial products standard. review process begins by reviewing the claiming effectiveness against To determine whether the proposed available information in the possession invertebrate species. use of the pesticide will not cause of the Agency and then determining if This rulemaking proposes to create a unreasonable adverse effects, EPA and what data are needed to assess the new subpart R for invertebrate product generally considers the maximum current risks of a particular pesticide. performance requirements to capture proposed use of a new pesticide to Thus, as with registration, the data the updates to the product performance estimate the maximum exposure needed and the scope and depth of the data requirements for pesticides, and to potential, evaluates the hazard data on Agency’s review for registration review make conforming edits to subparts E, U, the pesticide, and compares the rates at continue to be tailored to the specific V, and W. which effects are found based on well circumstances and use of the registered IV. Background conducted studies with the maximum pesticide. Section 3(g)(2)(A) of FIFRA exposure estimate. However, for authorizes EPA to require generation Since the early years of the pesticides intended for use against pests and submission of additional data registration program, EPA has waived of public health or economic necessary for registration review the need for product performance data importance, EPA has for some time pursuant to its authority under FIFRA for many pesticides, consistent with the considered whether the pesticide may section 3(c)(2)(B). congressional authority in FIFRA cause human health, environmental or section 3(c)(5), to waive such data and economic harm if its use as proposed III. Regulatory Framework to not make the finding that a proposed will not work as intended or claimed. The existing regulatory data pesticide’s ‘‘composition is such as to Data on the pesticide’s performance requirements for product performance warrant the proposed claims for it.’’ (44 under the conditions of use proposed for pesticides are contained in 40 CFR FR 27932, May 11, 1979) (FRL–2767–8). are essential to make this determination. part 158, subpart E, and for the most However, EPA did not codify its early part the table in 40 CFR 158.400(d) is intent not to waive product performance A. Registration specific to vertebrates (e.g., birds, data for pesticides intended for use Section 3 of FIFRA contains the rodents, etc.); 40 CFR part 158 subpart against certain invertebrate pests. requirements for granting and W also contains pesticide data Specifically, in May of 1979, EPA maintaining registration. FIFRA section requirements for antimicrobials. initially announced the need for 3(c)(2) provides EPA broad authority, However, subpart E does not product performance data for before and after registration, to require specifically require submission of ‘‘[i]nvertebrate control products scientific testing and submission of the product performance data for those intended for use in or on humans (or in resulting data to the Agency. Under this pesticide products claiming or on pets for control of pests which authority, EPA requires such testing and effectiveness against invertebrate pests attack humans) to control pests such as submission of data through rulemaking, (e.g., insects, spiders, etc.). Instead, the fleas, mites, lice, ticks, biting flies, and see, 40 CFR part 158 or, for existing test note in 40 CFR 158.400(e)(1) mosquitoes’’ and for‘‘[i]nvertebrate registrations, through issuance of a contemplates requiring the submission control products intended for use either ‘‘data call-in.’’ (See, FIFRA section of product performance data on a case- in premises or in the environment to 3(c)(2)(B)). EPA may also request further by-case basis, consistent with the control pests of sanitary or public health data if the data submitted fail to general authority in 40 CFR 158.75 to significance such as mosquitoes, biting adequately address an issue necessary require additional data as part of the flies, ticks, fleas, houseflies, for making the requisite statutory registration process, if the information cockroaches, fire ants, hornets, wasps, findings. (See, 40 CFR 158.75). that is required and submitted for poisonous spiders, scorpions, Consistent with the requirements EPA registration is not sufficient to make the centipedes, and bedbugs.’’ (44 FR has imposed and the data that have been requisite statutory findings. EPA has 27932, May 11, 1979) (FRL–2767–8). In identified as needed to review relied on these authorities for some contrast, in other subsequent applications for registration of years to obtain needed product rulemaking actions, EPA announced its pesticides of significant health or performance data for conventional intent to require product performance economic importance, an applicant for pesticides intended for use against data only for products ‘‘where lack of registration must furnish EPA with data certain invertebrate pests of public control would clearly result in adverse on the pesticide, its composition, health or economic significance. health effects’’ (47 FR 40659, September toxicity, potential human exposure, Although the updating of 40 CFR part 15, 1982) (FRL–2138–1) or where environmental properties and ecological 158 regulations began years ago, EPA ‘‘control cannot reasonably be observed effects, as well as its product made no changes to the product by the user . . .’’ (47 FR 40659, 40661) performance (efficacy). performance data requirements at 40 because other pests were more of an CFR part 158, subpart E, as they relate aesthetic and nuisance problem rather B. Registration Review to the invertebrate pests covered in this than one of public health. FIFRA section 3(g) mandates that the action. (72 FR 60934, October 26, 2007) Ultimately, EPA’s final part 158 rule registrations of all pesticides are to be (FRL–8106–5). However, EPA did make announced that EPA had ‘‘decided to periodically reviewed. Periodic review some changes to the data requirements rescind the proposed efficacy data is needed as changes in science, public for biochemical and microbial waiver with respect to vertebrate control policy, and pesticide use practices occur pesticides by codifying product agents intended for control of pests that

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directly or indirectly transmit disease to A. Why does product performance Consequences can also include both humans’’ and included a test note matter? health and economic impacts. For indicating that EPA waived product The primary goal of this proposal is example, the common bed bug (Cimex performance data ‘‘unless the pesticide to assure that pesticide products lectularius) has long been a pest, feeding product bears a claim to control pest claiming effectiveness against an on blood, causing itchy bites and microorganisms that pose a threat to invertebrate pest of significant public generally irritating their human hosts. human health and whose presence health or economic importance perform EPA, CDC, and the USDA all consider cannot readily be observed by the user effectively. This action addresses both bed bugs a pest of significant public including, but not limited to, health concerns and economic health importance. Bed bugs can cause microorganisms infectious to man in consequences stemming from pesticide a variety of negative physical health, any area of the inanimate environment, products that might not perform as mental health, and economic consequences. Effects can include: or a claim to control vertebrates (such as claimed on the label. EPA acknowledges • Allergic reactions to the bed bug that use of the term arthropod would rodents, birds, bats, canids, and skunks) bites, which can range from no reaction include all the pests identified in this that may directly or indirectly transmit to a small bite mark to, in rare cases, diseases to humans. However, each document. However, product anaphylaxis (severe, whole-body registrant must ensure through testing performance data for additional reaction). that his/her product is efficacious when invertebrate species, such as (but not • Secondary infections of the skin, used in accordance with label directions limited to) gastropods (snails and slugs) such as impetigo, ecthyma, and and commonly accepted pest control that serve as intermediate parasite hosts lymphangitis. practices. The Agency reserves the right or invasive mussels of ecological • Mental health impacts on people to require, on a case-by-case basis, concern could be needed in the future. living in infested homes. Reported submission of product performance data To account for the potential for future effects include anxiety, insomnia and for any pesticide product registered or data needs, EPA will use the terms systemic reactions. (Refs. 7 and 8). proposed for registration.’’ (49 FR invertebrates or invertebrate pests in Bed bug infestations are also an 42856, 42875, October 24, 1984) (FRL– reference to pests in all three categories economic burden on society. The 2591–5); 40 CFR 158.400(e)(1). That (pests of significant public health economic losses from health care, lost importance, invasive species, and wood- provision remains largely unchanged wages, lost revenue and reduced destroying insects). productivity can be substantial. The cost today, although in the subsequent Consistent with the regulatory text in updates to the data requirements for of effectively eliminating bed bugs may 40 CFR 158.400(e)(1) and as noted in be significantly more than the cost of microbial and biochemical pesticides, PRN 2002–1 and PRN 96–7: Termiticide eliminating other pests because bed bug EPA made clear that the submission of Labeling, (Ref. 3). EPA has regularly control usually requires multiple visits efficacy data would be required if ‘‘the exercised its discretion to require by a licensed pest control operator and pesticide product bears a claim to submission of product performance data diligence on the part of those who are control . . . invertebrates (including but for pesticides intended for use against experiencing the infestation. Control in not limited to: mosquitoes and ticks) invertebrate pests of significant public multi-family homes is much more that may directly or indirectly transmit health importance and of product difficult than in single family homes diseases to humans.’’ (40 CFR performance data on pesticides because bed bugs frequently travel 158.2160). Thus, existing EPA intended for use against invertebrate between units, either by direct transport regulations for conventional pesticides pests of significant economic by humans or through voids in the continue to presume the waiver of importance. Since 1984, particularly for walls. Thus, there are additional costs product performance data for insect repellents, the awareness of the and complexities associated with invertebrate pests unless EPA exercises incidence and severity of mosquito- and coordinating and encouraging its discretion to require on a case-by- tick-borne diseases in the U.S. has participation from multiple residents. case basis submission of the data to changed. Mosquitoes and ticks are not Also, if the pesticide product claiming support claims against pests, including merely nuisance pests: The Centers for to treat bed bugs is not effective and pests of significant public health Disease Control and Prevention (CDC) families are forced into repeated (and importance. has determined that a single bite can expensive) cycles of re-treatment, then transmit sufficient infectious material, In 2002, EPA issued Pesticide serious health and economic impacts i.e., a sufficient amount of pathogen, to can occur. Registration Notice (PRN) 2002–1 in cause serious, and sometimes fatal, While wood-destroying insects/ compliance with the requirement in disease. (Ref. 4). This is true for both structural pests are not pests of FIFRA section 28(d) to coordinate with mosquito-borne diseases such as West significant public health importance, United States Department of Health and Nile Virus, St. Louis Encephalitis, and they are similar in that the Human Services (HHS) and United the Zika virus, and tick-borne diseases consequences of ineffective treatments States Department of Agriculture such as Lyme Disease. (Refs. 5 and 6). can be severe. Unfortunately, the (USDA) in identifying pests of If a person can become ill because of effectiveness of a treatment to protect a significant public health importance. a single insect bite, a person using an wooden structure is not readily The list of pests identified in that PRN ineffective insect repellent may not have apparent to the applicator at the time of was ‘‘derived in large part from review the opportunity to realize that the insect application or during the occupancy of of the pesticide/pest combinations for repellent did not work as expected and the building or home. It is only after the which efficacy (product performance) then correct the situation by purchasing damage becomes apparent that the data are generally required to be another product. Given the nature of extent of needed repairs is determined. submitted and reviewed prior to these and other mosquito- and tick- There is a potential for significant registration.’’ (Ref. 2). EPA is the process borne diseases, an ineffective insect financial loss to the property owner. of updating this document and has repellent can have serious and Thus, demonstrating the efficacy of recently made an updated draft sometimes fatal consequences to a pesticides intended to control structural available for public comment (Ref. 2). person’s health. pests has a unique importance. Data on

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the level of economic damage caused by consistent with the results of the scientific organizations. New or revised structural pests on an annual basis are supporting product performance data. guidelines are typically presented to difficult to obtain but several authors EPA believes that having reliable SAP for peer review. The purpose for have attempted to quantify it. The information concerning the harmonizing these guidelines into a economic costs of termite property effectiveness of pesticide products that single set of OCSPP guidelines is to damage, preventative treatments, and claim effectiveness against invertebrate standardize testing procedures that structural repairs can be quite severe, pests results in sound regulatory should be performed to meet the with estimated cost at approximately $5 decisions and accurate information on Agency’s data requirements under billion annually. (Refs. 9 and 10). While the labeling. Accurate labeling claims FIFRA and TSCA. EPA’s Invertebrate these estimates are indicative of the cost provide consumers with information Control Agents, Product Performance nationwide, the costs borne by an they need concerning the effectiveness Guidelines are listed in Table 2. individual property owner can be of the pesticide. The guidelines themselves do not significant in their own right, up to and 2. Label Review Manual. Consistently, impose requirements. Instead, they including, loss of the structure. the Agency has in the Label Review provide recognized methods for Manual explained the historical need B. Labels conducting acceptable tests, guidance for product performance data for on reporting data, and definitions of 1. Label requirements. Pesticide products intended for invertebrate terms. Since these are guidance, product labeling provides information control. The Label Review Manual has pesticide registrants are not required to to users on, among other things, the for some time summarized the Agency’s use these guidelines to fulfill data product’s intended uses, and how to current practice of requiring product requirements. Applicants may instead handle and apply the produEPA’s performance data to support claims for seek to fulfill the data requirements by labeling regulations are contained in 40 pesticides intended for use in or on other appropriate means or by using a CFR part 156. EPA reviews pesticide humans (or in or on pets for control of non-guideline protocol. The applicant pests which attack humans such as labels to determine whether the labeling may submit a protocol of his own fleas, ticks, mosquitoes, and biting flies) is consistent with EPA’s regulations, devising for the Agency to review. EPA and in premises or in the environment and is accurate, clear and enforceable. notes that there is a PRIA fee category to control pests of sanitary or significant The accuracy of the information on the for submitting a protocol for EPA to public health importance such as labeling is of particular importance for review. termites, wasps, scorpions, poisonous products making a claim to kill or repel spiders, fire ants, cockroaches, The guidelines identify thresholds for pests of significant public health centipedes, and bedbugs. (Ref. 11). determining whether a product is importance and wood-destroying pests. effective. Since these thresholds are in Such pests, if uncontrolled, can transmit C. EPA’s Harmonized Test Guidelines guidance (not codified requirements), disease pathogens, thus posing a widely for Invertebrate Product Performance they are considered recommendations recognized and significant risk to 1. Existing Guidelines. EPA has and not mandatory. EPA also human health, and can result in established a unified library for test acknowledges that the older (1998) significant economic impacts. guidelines issued by the Office of guidelines, in particular, generally lack Consumers purchase products that Chemical Safety and Pollution adequate, up-to-date guidance on claim effectiveness against a pest of Prevention (OCSPP) for use in testing efficacy data development, test significant public health importance chemical substances to develop data for protocols, and representative test precisely to avoid the harm these pests submission to EPA under the Toxic species. can cause. Consumers have a reasonable Substances Control Act (TSCA) and EPA notes that the Product expectation that the claims on the FIFRA. This library of test guidelines Performance Guideline 810.1000 pesticide label have a scientific basis, represents an Agency effort that began entitled, ‘‘Overview, Definitions, and i.e., are based on valid evidence, and are in 1991 to harmonize the test guidelines General Considerations,’’ discusses that neither false nor misleading. Such within OCSPP, as well as to harmonize product performance data are needed claims should be expressed using the OCSPP test guidelines with those of for any product that ‘‘bears a claim to wording or graphics that are easily the Organization for Economic control pests that may pose a threat to understood and require little or no Cooperation and Development, which human health.’’ This is specifically interpretation by the consumer. To includes representation of countries, stated to include: ensure that labeling provides consumers including the U.S., throughout the Public health uses of invertebrate with accurate information concerning world. The process for developing and control agents including, but not limited how long and how well the product amending the test guidelines includes to, agents intended to control the works, EPA reviews and evaluates several opportunities for public following: Mosquitoes, biting flies, ticks, product performance (efficacy) data. participation and extensive involvement fleas, houseflies, cockroaches, fire ants, Once the data have been reviewed and of the scientific community, including hornets, wasps, poisonous spiders, evaluated, then the Agency works to peer review by the FIFRA Scientific scorpions, biting midges, centipedes, ensure that the labeling use directions Advisory Panel (SAP), the Science bedbugs, human lice, and dust mites. and labeling claims are clear and Advisory Board (SAB), and other expert (Ref. 12).

TABLE 2—EPA’S SERIES 810, GROUP C—INVERTEBRATE CONTROL AGENTS, PRODUCT PERFORMANCE GUIDELINES

OCSPP guideline No. Guideline Title (Date)

810.3000 ...... General Considerations for Efficacy of Invertebrate Control Agents (1998). 810.3100 ...... Soil Treatments for Imported Fire Ants (1998). 810.3200 ...... Livestock, Poultry, Fur- and Wool-Bearing Animal Treatment (1998). 810.3300 ...... Treatments to Control Pests of Humans and Pets (March 1998). 810.3400 ...... Mosquito, Black Fly, and Biting Midge (Sand Fly) Treatments (1998). 810.3500 ...... Premise Treatments (2019).

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TABLE 2—EPA’S SERIES 810, GROUP C—INVERTEBRATE CONTROL AGENTS, PRODUCT PERFORMANCE GUIDELINES— Continued

OCSPP guideline No. Guideline Title (Date)

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

D. Guideline Modifications Needed for 2), which presented the ‘‘List of Pests of EPA takes this approach when only the Future Significant Public Health Importance.’’ certain members of a taxonomic group Those guidelines from 2004 and This document is currently under may be of public health significance before require revision to remove any revision within the Agency. The 2002 because labels usually do not identify stated performance standards. Until the list was derived in large part from specific individual species. However, revisions can be made, this rule would review of the pesticide/pest even if the label did identify a specific supersede any species requirements or combinations for which product species, most product users are not able performance standards stated, or performance data have been required on to distinguish among the members of a implied, in the guidelines applicable to a case-by-case basis to be submitted and taxonomic group (i.e., identifying one invertebrate pests. EPA intends that any reviewed prior to registration. This list tick species from another). inconsistency that may exist between was developed cooperatively by the U.S. The invertebrate species of significant the guidelines and this rule should be Department of Housing and Urban public health importance identified in resolved in favor of the regulations, Development, USDA, and EPA, with this proposed rule as requiring once those regulations are finalized. input from some non-governmental submission of product performance data entities. EPA’s Office of Pesticide are derived from the invertebrate pest V. Selection of Pest Categories for Programs coordinated the review by list identified in PR Notice 2002–1. Subpart R experts in public health and/or Differences that exist between the EPA has selected three pest categories pesticide use patterns to compile this species identified in the PR Notice and for this proposed rule: Pests of list. this proposed rulemaking represent the significant public health importance, As indicated in PRN 2002–1 (page 1), evolution of our understanding of the wood-destroying insects, and invasive the criteria for inclusion on the list were testing required to support claims species. The rationale for selection of defined ‘‘broadly, to include pests that against pests of public health concern. these three categories follows. pose a widely recognized risk to These invertebrate pests pose a threat of significant numbers of people.’’ injury, disease transmission and/or A. Pests of Significant Public Health The listing of invertebrate pests (pages pathogen transfer, and allergen Importance. 6–9) is specified by the taxonomic production. Table 3 provides the 1. Background. As previously noted, name, as not all members of a particular rationale for inclusion in this rule of an in 2002, EPA issued Pesticide taxon may be considered a pest of invertebrate pest as a pest of significant Registration Notice (PRN) 2002–1 (Ref. significant public health importance. public health importance.

TABLE 3—PESTS OF SIGNIFICANT PUBLIC HEALTH IMPORTANCE FROM PRN 2002–1

Invertebrate pest (common species name) Rationale for inclusion

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

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

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

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during the occupancy of the building or human health impacts that invasive serious situation/crisis exists in New home, and a potential for significant species cause . . . .’’ The Executive England, and USDA has established an financial loss to the property owner Order directed each federal agency to extensive eradication program. EPA has exists. EPA has generally required use relevant programs and authorities also registered several products for use submission of product performance data to: against the Asian longhorned beetle. • for wood-destroying insects for over 40 Prevent the introduction of invasive Invertebrates such as the emerald ash years. USDA registered pesticides prior species; • borer and the Asian longhorned beetle to establishment of the EPA and also Detect and respond rapidly to and kill trees over very large geographic required product performance data in control populations of such species in a areas, thus, having substantial support of wood-destroying insects. The cost-effective and environmentally ecological and economic impacts by Agency issued PRN 96–7, entitled sound manner; destroying both urban cover and forests • Monitor invasive species ‘‘Termiticide Labeling,’’ (October 1, used for recreation purposes and timber populations accurately and reliably; 1996) (Ref. 3) to provide guidance on stands. According to a 2011 analysis • Provide for restoration of native label statements and minimum levels of (Ref. 26) entitled, ‘‘Economic Impacts of species and habitat conditions in product performance for soil treatment Non-Native Forest Insects in the ecosystems that have been invaded; use of termiticide products. According • Continental United States,’’ the to the PRN: Conduct research on invasive species and develop technologies to following five categories of expenditures The Agency believes that registration of a prevent introduction and provide for and losses can be used to illustrate [termiticide] product demonstrating less than impacts on forests. five (5) years of efficacy for control of environmentally sound control of invasive species; and • Federal government expenditures termites is generally not appropriate from a • safety or efficacy standpoint, considering the Promote public education on (survey, research, regulation, costs of treatment and the potential damage invasive species and the means to management, and outreach), that could occur. The Agency does not address them. • Local government expenditures believe that the homeowner should be Invertebrate invasive species can (tree removal, replacement, and subjected to such costly protection as would impose serious economic costs by treatment), occur with products that are only efficacious causing or vectoring diseases against • Household expenditures (tree for one year. Such products could, quite native species that have little or no possibly, pose unreasonable adverse effects removal, replacement, and treatment), natural defenses. For example, an to the environment and/or humans because • Residential property value losses, invasive species of significant note is of higher risks than longer-acting and the emerald ash borer, a wood boring alternatives. The more frequent treatments • required could result in greater exposure and beetle that is native to Asia. The Timber value losses to forest risk, or lower benefits, because of being less emerald ash borer kills ash trees. Its landowners. effective if not retreated, or more expensive presence was reported in southeast Within the 2011 analysis were cost if retreated. Michigan and Windsor, Ontario in 2002. estimates using the five previously * * * * * Since then it has spread to at least 35 described categories of the damage EPA has always required efficacy data to be states and five Canadian provinces. caused by three types of invasive submitted by registrants to demonstrate that Infested areas are under quarantine and insects: Borers, sap feeders, and foliage termiticides perform their intended function feeders. Since some of the economic as claimed. EPA has reviewed such data prior restrictions have been imposed on to registration to assure that the benefits of moving fire wood. EPA has registered categories overlap, the total sum of all the use would outweigh the potential risks. several pesticide products for use economic categories would include against the emerald ash borer after some double counting. However, the C. Invasive Species reviewing submitted efficacy data. (Ref. total of the insect types can be summed On February 8, 1999, President 24) without double counting, which means Clinton signed The Executive Order Another invasive invertebrate species, that it is appropriate to sum the 13112 (64 FR 6183) (February 8. 1999), the Asian longhorned beetle, is also columns, but not the rows. Table 4 which is intended to ‘‘. . . to prevent native to Asia and was first discovered shows that most of the costs are borne the introduction of invasive species and in New York in 1996. The Asian by local governments and households, provide for their control and to longhorned beetle kills maple trees and and the total damage is several billion minimize the economic, ecological, and other hardwoods. (Ref. 25). A very dollars.

TABLE 4—ANNUALIZED INVASIVE SPECIES DAMAGES IN THE U.S. [$ millions]

Federal Local Residential Forest government government Household property landowner expenditures expenditures expenditures value loss timber costs

Borers ...... $92 $1,700 $760 $830 $130 Sap Feeder ...... 14 170 130 260 4 Foliage Feeders ...... 110 170 160 410 18

Total ...... 216 2,040 1,050 1,500 152

Pesticide products are an important The availability of pesticide products circumstances necessitate the tool for managing the spread of an with proven performance against an submission or citation of reliable data to invertebrate invasive species and the invasive species is important to slowing support claims for controlling invasive related significant economic impacts. the spread of the invasive species. When

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species, EPA has the authority to require VII. Introduction to Part 158, Subpart R registration is sought. This includes referring to all parts of subpart R, such product performance data. A. General Due to the sudden appearance and identifying the claims intended to be EPA is proposing to codify product made on the product labeling, reviewing often rapid spread of invasive species, performance data requirements and understanding the performance EPA does not presently propose to pertaining to registration of pesticide standards that must be met or exceeded codify a comprehensive list of all the products claiming efficacy against for the identified claims against the specific invasive species for which certain invertebrate pests. The proposed target pests, and understanding all product performance data might be data requirements are consistent with applicable test notes. deemed necessary. At this time, EPA is the Agency’s current practices 2. Definitions. In order to ensure specifically proposing to codify product concerning the data needed to register a consistent implementation of proposed performance data submission pesticide product that claims subpart R, EPA is proposing definitions requirements for the emerald ash borer effectiveness against invertebrate pests. specific to the subpart. Proposed 40 CFR and the Asian longhorned beetle. The The proposed data requirements are 158.1701 and 158.1703 contain the submission of product performance data presented, as appropriate, in table definitions pertaining to subpart R. In to support claims for effectiveness formats, with the needed data specified particular, proposed 40 CFR 158.1701 against other invasive invertebrate pests according to the claim on the label, the defines many of the terms that are will be considered on a case-by-case species to be tested, and the needed to assure a common basis. performance standards to be met. Once understanding of the requirements and final, the regulations will provide the performance standards being proposed VI. Development of Invertebrate Pest regulated community and other for codification under subpart R. Groups and Subgroups interested parties a better understanding During the 2013 SAP, EPA received of the data required to support public comments and feedback from the EPA has identified pest groupings on registration of a pesticide product SAP on the proposed definitions in the the basis of the biology and life history making a claim against an invertebrate Technical Support Document (TSD) characteristics of the pests identified as pest identified to be a public health provided to the SAP. (Ref. 28). In public health or wood destroying pests. concern (e.g., ticks, mosquitoes, addition, the SAP recommended several (Ref. 28). The groupings are cockroaches, etc.), a wood-destroying additional definitions that should be taxonomically based. ‘‘Pest groups’’ and insect (e.g. termites), or an invasive considered under this proposed ‘‘pest sub-groups’’ are designations invertebrate species (e.g. Asian rulemaking. After considering the simply intended to convey the fact that longhorned beetle). comments provided, and based on the some pests groups are part of larger The Agency is proposing to title the data requirements being proposed in groups. Therefore, when practical, ‘‘pest new subpart R in part 158, ‘‘Product this rulemaking, the proposed sub-groups’’ have been identified to Performance for Products Claiming definitions represent those that are most define a meaningful subset of the larger Effectiveness Against Invertebrate essential for understanding the group. Pests.’’ The existing product requirements and regulatory text of the performance data requirements in proposed subpart R. For those EPA developed the pest groups and subpart E will be renamed ‘‘Product definitions that the SAP and public pest sub-groups with the intention that Performance for Products Claiming commenters provided feedback on or product performance testing performed Effectiveness Against Vertebrate Pests, that were recommended then, but not on a particular species can adequately Products with Prion-related Claims, and included in this proposal, EPA intends represent all members of the pest group Products for Control of Organisms to consider the utility of those (or pest sub-group). The Agency intends Producing Mycotoxins.’’ Additionally, definitions and will consider these pest groupings to decrease data EPA is proposing conforming edits to incorporating them into future guidance submission burdens on applicants and subparts U, V, and W. and rulemakings. The SAP and public data review burden on the Agency as comments on definitions associated well as increasing the consistency, B. Contents of Proposed Subpart R with product performance data reliability, and integrity of data 1. General requirements. Proposed 40 requirements are available in the docket submitted to EPA. In some cases, EPA CFR 158.1700 contains the general for the SAP [EPA–HQ–OPP–2012– is proposing pest-specific claims, in requirements that would be applicable 0574]. EPA’s response to those addition to group and sub-group claims. to any pesticide product that is making comments are discussed in this a claim(s) against an invertebrate pest, To develop these groupings, EPA document and associated docket. Other and describes how to use the data tables considered species sensitivity. In certain definitions included in the TSD have in proposed subpart R. These general since been adopted in testing cases, one member of a pest grouping is requirements describe when product guidelines. known to be significantly harder to kill, performance data may be required, Where applicable, EPA derived the control, or repel than other members of specifically for products that bear a proposed subpart R definitions from the grouping. If product performance claim against a pest of significant public existing guidelines. The definition for testing is performed using the species health importance or a pest of economic Complete protection time is very similar that is harder to kill, control, or repel, significance. The required tests must be to the one found in Guideline 810.3700. then logically, it can be assumed that conducted using the end-use product to The proposed definition of Skin-applied the results of this testing can be ensure that the product’s claims are insect repellent is taken from Guideline extrapolated to other members of the supported in the form in which the user 810.3700. The proposed definitions for grouping. Additional considerations will be using the product. Soil-applied termiticides, and Bait included the availability of species in a Additionally, proposed 40 CFR treatment were derived from laboratory setting, the occurrence of 158.1700 provides a set of instructions information in Guidelines 810.3600 and species over wide areas and/or those on how to determine the product 810.3800. For example, the Bait species most commonly associated with performance data required to support treatment proposed definition is similar transmission of diseases to humans. the pesticide product use for which to Termite bait in Guideline 810.3800.

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The definition of Vector is very similar mosquitoes and ticks transmit disease to to in the portions of the proposed to that in FIFRA 2(oo). man. Or, a claim is made to kill bedbugs. regulatory text for the wood-destroying In the TSD presented to the 2013 SAP, Bedbugs are injurious to man. invertebrate pests. EPA explained a pesticide for use —The pesticide product is used in public 4. Performance Standards. In against invertebrates and meeting one of health programs for vector control or for proposed 40 CFR 158.1704, EPA is other recognized health protection uses to the following circumstances might be prevent or mitigate threats to public health. proposing a set of performance characterized as making a public health —The pesticide product contains one or standards that, in the absence of pest claim requiring submission of more ingredients that, under the criteria in performance standards specified product performance data: 40 CFR 153.125(a), is an active ingredient elsewhere in subpart R, will apply • A claim is made to control, kill, with respect to a public health organism generally and must be met for data cited knockdown, and/or repel specific and there is no other functional purpose to be considered acceptable in support invertebrate organisms that are directly for the ingredient in the product. of a specific labeling claim on the or indirectly infectious or pathogenic or —The pesticide product is similar in product’s labeling. composition to a registered pesticide a. Performance standards for skin- injurious to humans (or both humans product that makes explicit public health and animals). For example: A claim is claims for control of invertebrate applied insect repellents: EPA is made to repel mosquitoes and/or ticks. organisms. (Ref. 28) proposing that for skin-applied insect Both mosquitoes and ticks transmit repellent labeling claims, the EPA believes that the circumstances disease to humans. Or, a claim is made performance standard must be greater presented in the 2013 TSD, in principle, to kill bed bugs. Bed bugs are injurious than or equal to 2-hours complete identify the kinds of pesticides for to humans. protection time. • The pesticide product is used in which product performance data may be Complete protection time (CPT) is public health programs for vector necessary. EPA also notes that existing defined in Guideline 810.3700 as ‘‘the control or for other recognized health regulations at 40 CFR 158.2204 provides time from application of a repellent protection uses to prevent or mitigate definitions for a ‘‘public health claim’’ until efficacy failure as it is defined in threats to public health. and a ‘‘nonpublic health claim’’ as they each study—for example, the time from • The pesticide product contains one pertain to antimicrobial pesticide application until the first efficacy failure or more ingredients that, under the claims. EPA is not proposing to make event confirmed within 30 minutes by criteria in 40 CFR 153.125(a), is an any modifications to that provision, and a second similar event.’’ CPT has been active ingredient with respect to a any definition for a ‘‘public health pest the existing practice for determining public health organism and there is no claim’’ added to subpart R would be efficacy of skin-applied insect repellents other functional purpose for the applicable only within proposed since the guideline was finalized in ingredient in the product. subpart R. 2010. EPA presented this concept, along • The pesticide product is similar in 3. Application Categories. In proposed with a proposed minimum protection composition to a registered pesticide 40 CFR 158.1703, EPA is proposing to time of 2-hours, to the SAP in the TSD, product that makes explicit public define a set of application categories to as a means of ensuring that a skin- health claims for control of invertebrate assist in defining the data needed to applied repellency product protects for organisms. support registration. This section would a minimum amount of time given the EPA still agrees that these only define application categories to the potential variability of product results circumstances, in principle, identify the extent the terms appear in the proposed across different people. kinds of pesticides for which product regulatory text and EPA believes they The Agency believes that establishing performance data may be necessary. require definition. For example, the a minimum CPT for skin-applied However, EPA is not proposing to terms ‘‘bait treatments’’ and ‘‘spatial repellency products should be required codify the term ‘‘public health pest repellents’’ are defined. This section because of the large variability in claim’’ as a means of identifying when does not provide a listing of all protection times experienced by data are required. Such a term is not application categories that would be susceptible individuals in the necessary given the proposed regulatory covered by the proposed subpart R data population. The SAP agreed that this text includes sections that specify the submission requirements. was a reasonable standard, stating that invertebrate pests and invertebrate pest Application categories describe how ‘‘[i]f CPT is to be used, a minimum CPT groups/subgroups that would be subject and/or where the product is intended to of 2 hours was suggested by the Panel to the proposed product performance be applied or used. The proposed as a minimal criterion for product data requirements if the pesticide is application categories were derived after registration . . . A repellent of shorter intended for use against those pests. consideration of current practices and duration may not provide sufficient, EPA requests comment on whether review of the application sites included useful protection in practical terms and there is utility in codifying an in the Harmonized Test Guidelines will give consumers a false sense of overarching definition of a ‘‘public (810.3000 through 810.3900). protection.’’ (Ref. 29). health pest claim’’ for the purposes of Oftentimes, these application categories Additionally, EPA is proposing subpart R, and if so, whether the will be used on pesticide product regulatory text for skin-applied products definition presented to the SAP is labeling, and, therefore, may be that reinforces that any testing required appropriate. identified as a product performance under part 158 which involves any In the 2013 TSD EPA wrote that: labeling claim within the data human subjects must comply with all requirement tables. Similar to the applicable requirements under 40 CFR A public health claim is asserted if one or definitions in 40 CFR 158.1701, EPA part 26. For example, 40 CFR part 26 more of the following apply: received SAP feedback on some of the requirements are pertinent to 40 CFR —A claim is made to control, kill, application category definitions. (Ref. part 158 testing requirements if the knockdown, and/or repel specific invertebrate organisms that are directly or 29). The application categories proposed testing involves intentional exposure of indirectly infectious or pathogenic or in 40 CFR 158.1703 represent EPA’s human subjects. Protocols for such injurious to man (or both man and responses to that feedback for the testing must be submitted to EPA for animals). For example: A claim is made to application categories as applicable. review prior to study initiation. Those repel mosquitoes and/or ticks. Both These application categories are referred protocols determined by EPA to involve

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intentional exposure of human subjects level of control. Human mites and lice used as guidance. (Ref. 32). EPA is also require review by EPA’s Human will retain a 100% standard, while the specifically proposing to codify product Studies Review Board (HSRB)) prior to wood-destroying pests will have a 95% performance data submission study initiation. or greater standard for prevention of requirements for the emerald ash borer b. Performance standards for products damage to wood, except for non- and the Asian longhorned beetle. The other than skin-applied insect structural wood preservative treatments, submission of product performance data repellents. Unless otherwise specified in which will have a standard of 100%. to support claims for effectiveness the proposed 40 CFR 158.1700– The standards for human mites, lice, against other invasive invertebrate pests 158.1786, EPA proposes that the and wood-destroying pests will be will be considered on a case-by-case performance standard for a product discussed in more detail in other basis. performance claim against a pest must sections of this proposed rule. EPA notes that the Agency currently be greater than or equal to 90 percent. 5. Test Guidelines. In proposed 40 has authority to require data submission For non-wearable spatial repellents, the CFR 158.1705, EPA is codifying a on a case-by-case basis when necessary proposed performance standard is reference to EPA’s Harmonized Test to evaluate a pesticide product (see 40 greater than or equal to 75%. Guidelines, which set forth a CFR 158.75). This provision is intended In the TSD presented to the SAP, EPA recommended approach to generate the to clarify that whether or not a claim is was considering performance standards data required for product performance against an invasive species is a factor in of 95% for all other pest claims, with testing. determining whether product the exception of mites, lice, carpenter 6. Data Requirement Modifications. In performance data is necessary to ants, wood destroying beetles, and proposed 40 CFR 158.1707, EPA is evaluate a pesticide. termites. The 95% performance proposing to state that on a case-by-case 8. Invertebrate Disease Vector Claims. standards were initially chosen because basis, the data requirements identified In proposed 40 CFR 158.1709, EPA is they represented widely accepted in subpart R may need to be adjusted for proposing that if a registrant requests a standards at the time. (Refs. 28, 29, 30 novel technologies or because a labeling claim specific to a disease and 31). EPA proposed these standards product’s unusual physical, chemical, vector, additional testing conducted as a way to ‘‘define the levels of product or biological properties or atypical use with the species specific to that disease performance that would need to be met patterns would make particular data vector claim is required if that species in order for the studies to support requirements inappropriate, either is not already required under subpart R product registration and labeling,’’ and because it would not be possible to as part of the pest group tested. For that proposing a specified threshold generate the required data or because example, if a product claims to repel level or performance standard would be the data would not be useful in the Asian longhorned ticks that may carry the ‘‘best means to assure that the Agency’s evaluation of the risks or Japanese spotted fever, caused by products used to control invertebrate benefits of the product. EPA Rickettsia japonica, then the registrant species are effective under conditions of recommends that registrants of novel must generate data using the species use.’’ (Ref. 28). technologies contact the Agency prior to that is known to carry the disease In response to the proposal, both the conducting product performance indicated, the Asian longhorned tick in SAP and public commenters believed testing. It should be noted that EPA has this case. This requirement will ensure that a 95% performance standard would historically taken the position that data that all disease vector claims are create a burden for unattainable results requirements can be adjusted or waived supported by appropriate product and would be cost prohibitive in most on a case-by-case basis per the performance data demonstrating the situations, particularly for large scale procedures described in 40 CFR 158.45. required performance standard should field trials, or in general, any field trial This provision is not intended to an unknown public health threat emerge using a 100% standard expectation. supersede or alter the provisions at 40 in the future. They argued that a minimum 90% CFR 158.45, but rather to clarify that 9. Structural and Wood-destroying performance under controlled EPA is proposing that the data Pest Claims. In proposed 40 CFR laboratory conditions would be requirements, including the 158.1710, EPA is proposing that if an adequate. (Refs. 28 and 29). While they performance standards, in subpart R application for registration or amended made this recommendation, the SAP may also be adjusted using the registration requests a labeling claim stated that in special cases, EPA should procedures consistent with those in 40 specific to a structural or wood- retain the authority to overrule these CFR 158.45. destroying pest that is not identified in standards if proper justification is 7. Invasive Species Claims. In 40 CFR 158.1782 through 158.1786, EPA provided by the applicants with regard proposed 40 CFR 158.1708, EPA is may require submission of product to why the standards should not be proposing that when an application for performance data to support those applicable to a particular product. registration or amended registration claims for effectiveness. This Additionally, the SAP stated that requests to put a claim(s) on its requirement will ensure that any claim registrants should be allowed to pesticide product’s labeling for against structural and wood-destroying compete by achieving higher than effectiveness against an invasive pests that have not been accounted for required performance standards, invertebrate species, then on a case-by- at this time are supported by product proving the superiority of their case basis, EPA may require submission performance data in the event that a products. of product performance data to support new threat emerges. After considering the SAP and public those claims for effectiveness. Due to 10. Pest Specific Claims. EPA is comments, with the exception of pests the sudden appearance and often rapid proposing to codify product such as human mites, carpenter ants, spread of invasive species, EPA does not performance data submission termites, and wood-destroying beetles, presently intend to codify a requirements for pest groups, sub- EPA is proposing performance comprehensive list of the specific groups, and some specific species. EPA standards of 90% or greater instead of invasive species for which product uses the term ‘‘Pest group labeling 95%. EPA believes that this standard performance data might be deemed claim’’ to mean a claim or statement on will enable acceptance of registrations necessary. USDA maintains a list of the labeling of the pesticide product that for products that provide a satisfactory invasive species profiles, which can be the product is effective against a group

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of related species or taxa demonstrating addition to any data submitted to Dust mites pose no direct threat of adequate similarity in basic biology and support the group claim against ‘‘filth injury, disease transmission, or life history characteristics to permit flies.’’ EPA also notes that the discomfort. However, dust mites are identification of representative test provisions at 40 CFR 158.75 and included as a pest of significant public species for the entire assemblage of taxa. proposed 40 CFR 158.1708 would also health importance because they produce The term ‘‘Pest sub-group labeling permit the EPA to require pest-specific allergens in their feces and cast claim’’ means a claim or statement on data on a case-by-case basis when exoskeleton that can result in asthma the labeling of the pesticide product that necessary to evaluate a pesticide and allergic reactions. EPA believes that the product is effective against a set of product. These provisions allow EPA to it is impractical to expect complete related species or taxa demonstrating address the Agency’s data needs in the elimination of the dust mite population adequate similarity in basic biology and face of emergent invertebrate pest in a structure. The focus should be to life history characteristics to permit concerns. reduce the agent of concern (i.e., the identification of representative test EPA requests comment on the pest- allergen) to acceptable levels. This can species and part of a larger identified specific claims covered by this proposed be achieved through a reduction in the taxonomic grouping (e.g., Biting flies) rule and whether there should be target pest that is less than is generally that includes other pest species, which additional pest-specific claims added to necessary for a pest that acts directly may or may not have a proposed pest subpart R, or if some of the ones against its host. EPA initially proposed group. The term ‘‘Pest-specific labeling included in the rule are unnecessary. a 75% performance standard to the SAP claim’’ means a claim or statement on for surface and fabric treatments, and a the labeling of the pesticide product that C. Data Requirements for Subpart R 95% performance standard for direct the product is effective against a The data requirements that EPA is application to dust mites. However, particular arthropod species, such as proposing for codification are consistent after considering the responses received German cockroach or house fly. with the Agency’s current practices through the SAP and public comment, In addition to the group and sub- when considering the product EPA is proposing a 90% performance group claims, EPA is proposing to performance data needed to register a standard for dust mites to be consistent codify requiring product performance pesticide product that bears a pesticidal with the recommendations provided on data for a number of pest-specific claim against one or more of these pests the performance standards for other claims. As previously noted, the or pest groups/sub-groups. FIFRA species testing. representative test species were selected section 3(c)(2) directs EPA to specify the During the SAP, one commenter on the basis of vigor of the pest species kinds of data that applicants and indicated that for mites, the proposed and the likely ability of the species to registrants must submit to EPA to performance standard of 100%, as serve as an adequate surrogate for other support regulatory determinations considered by EPA, was too high. pests in the group, as well as other under FIFRA. The data requirements for Instead the commenter advocated for factors including their availability for pesticide products are codified in 40 90%, while indicating that 95% would laboratory testing, ubiquity, and CFR part 158. be achievable. (Ref. 33). The 90% whether they are one of the primary standard is being proposed for some Product performance data (efficacy drivers of the human health concerns labeling claims for the dog follicle and studies) document how well the product within a grouping. (Ref. 1). The 2013 dust mites, but for human itch or performs the intended function (such as TSD envisioned that in many cases ‘‘[i]f scabies mites, EPA disagrees with killing or repelling) against an representative taxa are provided, species lowering the performance standard invertebrate pest. The product specific data may not be required, as the since scabies mites directly infect and group and any/all individual species performance data needs being are easily transferred among hosts. A within the group can be supported by considered in this rule would link the human skin-applied topical repellent supporting the general claim.’’ (Ref. 28). labeling claim for pesticide products performance standard of ≥2-hour For pests that are not listed as a ‘‘pest- claiming efficacy against an invertebrate complete protection time is also being specific claim’’ in proposed subpart R, pest with the data needed to proposed. EPA proposes that the data required to substantiate that claim. EPA views these EPA also notes that any testing support a group claim would also be standards as performance standards for conducted with human subjects must sufficient to support pest-specific claims the acceptability of data, and thus EPA comply with all applicable requirements for species within that group. For views them as waivable under 40 CFR under 40 CFR part 26. example, the pavement ant 158.45. 2. Chiggers. In the proposed 40 CFR (Tetramorium caespitum) is not listed as 1. Mites (excluding Chiggers). In 40 158.1714, EPA is proposing to require a pest-specific claim in proposed CFR 158.1712, EPA is proposing the testing for labeling claims against subpart R because it is not a pest of required test species and performance chiggers. Chiggers are being proposed in significant public-health importance standards in order to make a labeling the rulemaking due to their bites (nor is it a wood-destroying insect) and claim against dog follicle mites, dust causing itching and skin irritation with no pest-specific product performance mites, and the human itch or scabies the risk of a secondary infection. data would need to be submitted to add mite. EPA is proposing to list chiggers, Additionally, EPA is proposing the a claim against pavement ants to a label. which are mites, in a separate section. performance standards established In contrast, cluster flies (Pollenia rudis) As indicated in the TSD presented to under 40 CFR 158.1704 to apply to are listed as a pest-specific claim in this the SAP, dog follicle mite infestations testing for chiggers. proposed rule because of their are typically commensal in nature, but During the SAP, the Panel noted that significant public health importance. can cause demodectic mange in Trombicula alfreddugesi (as presented These pest-specific claims are consistent susceptible animals. This can pose a in the TSD) is now renamed as with EPA’s current practices. Thus, serious risk to stricken individuals, Eutrombicula cinnibars. EPA was consistent with the Agency’s current which typically have pre-existing unable to verify this and has maintained practices, pest-specific data would need immune system issues. For this reason, Trombicula alfreddugesi as was to be submitted to add a pest-specific a 100% performance standard is being presented in the TSD. EPA requests claim against cluster flies to a label in considered for these applications. comment on whether this is correct, and

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

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

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testing with the house fly is needed. The mosquitoes, as the SAP response better inform the decisions that EPA commenter suggested that testing with covered both required test species as needs to make. more than one species should only be well as how one arrives at conducting For testing of skin-applied insect needed for more specialized claims, the tests to collect the data. These repellents, EPA’s Guideline 810.3700, such as fly baits. (Ref. 36). comments are, as follows: entitled, ‘‘Insect Repellents to be In response, EPA included house flies • Suggested having separate tables for Applied to Human Skin’’ provides and the option to select between blow killing and repelling and for field and specific guidance (page 27) on the flies and flesh flies because these types lab testing choice of field testing sites. (Ref. 39). of flies move bacteria around from • Questioned the suitability of Culex According to the Guidance, ‘‘Field tests place-to-place when they land. This pipiens and C. quinquefasciatus in for mosquito repellency should be takes place by touching surfaces, as repellent studies conducted in at least two distinct these flies generally do not bite. ‘‘Filth • Suggested using Culex spp. instead of habitats (e.g., forest, grassland, salt flies’’ is a large grouping and testing on hybrids C. pipiens and C. marsh, wetland, beach, barns, or urban two species provides greater assurance quinquefasciatus environments) where the predominant that the product would be effective • Indicated Anopheles freeborni and A. mosquito species differ.’’ against most members of the pest group. punctipennis are suitable for field In field testing, a wide variety of House flies are generally the smallest in testing and not lab testing species are encountered. Thus, for field size of these three groups and therefore • Indicated Anopheles quadrimaculatus testing, the applicant’s submission will may be more susceptible to insecticides. is not suitable for indoor repellent provide information on the species Testing against the larger filth flesh/ testing captured during the testing. EPA will blow flies reduces the likelihood of • Suggested adding Anopheles review the data submitted to determine overestimating efficacy. albimanus and Anopheles stephensi if a sufficient number and type of Additionally, the SAP suggested the • Indicated Psorophora is acceptable for species were present. Generally, EPA cluster fly (Pollenia rudis) be deleted as field testing expects three different genera to be a test species. Instead, flies in the genus present: Culex, Aedes, and Anopheles. Fannia can be included since they can The SAP also noted that for field Claims against specific vector/disease be relatively easy to rear in laboratory testing of mosquitoes, certain species combinations must be supported by conditions. Fannia benjamini complex provided in EPA’s list could not readily testing of the specified vector. and Fannia scalaris (canyon fly and be obtained in a field test in the U.S. Additionally, because mosquitoes are latrine fly) were specifically mentioned. In response, EPA agrees that a listing high stakes vectors and because of the In response, the cluster fly was not of specific mosquito test species as difficulty consumers have in listed as a required test species for a provided in the TSD was confusing differentiating between species, for a claim against ‘‘Filth Flies’’ in the TSD. when considered in the context of field claim against any specific species of The cluster fly was specified as a test testing. With lab testing and semi-field mosquito, all the required test genera species if an applicant makes a pest- or ‘‘caged’’ testing a particular test must be tested. specific claim against the cluster fly. species can be selected. The particular EPA also agrees that certain species of Because house flies, blow flies, and species selected for testing could the mosquitoes specified in the TSD flesh flies are considered better depend on the colonies maintained by might not be obtained in a field test. representative species for the pest group the laboratory, as well as the type of However, the purpose of providing claim against ‘‘Filth Flies,’’ flies in the product being tested, and EPA believes multiple species is to offer flexibility in genus Fannia are not considered a providing a list of representative species how one complies with the data representative alternative to cluster that is comprehensive means that an requirements. In the proposal, EPA has flies. appropriate species could be identified not differentiated between what species 12. Mosquitoes. In proposed 40 CFR for a wide variety of product types or may be more obtainable in a field versus 158.1756, EPA is proposing data claims. laboratory test. requirements for a pest group claim With regards to Culex pipiens and Additionally, two commenters against ‘‘Mosquitoes.’’ For the Culex quinquefasciatus, EPA is aware provided other comments about how to performance standards, EPA is that these are now considered to be a obtain mosquito data, particularly in proposing standards consistent with hybrid mosquito complex. However, relation to using foreign data and proposed 40 CFR 158.1704. For the EPA believes that retaining the foreign species as surrogate data. One required test species, EPA is proposing historical names of the Culex species commenter, for example, suggested that that testing be required on at least one provides more appropriate context, foreign data be considered acceptable as mosquito species from three different given the possibility of more name long as the study is conducted genera (i.e., one out of three proposed changes over time. according to the 810.3700 guidelines. Culex spp.; one out of two proposed With regards to Anopheles (Ref. 40). Another commenter indicated Aedes spp.; and one out of six proposed mosquitoes, EPA has provided several that foreign species could be useful if Anopheles spp.). species for the applicant to consider sufficient colonies of domestic species One public commenter during the because some Anopheles mosquitoes are not available (e.g., declining SAP asked why the species Anopheles may not be appropriate for all types of colonies of US anopheline mosquito stephensi was missing from the list of testing, or colonies of some Anopheles species). (Ref. 41). EPA would like to species for mosquito testing in the TSD, mosquitoes may be difficult to maintain note that conducting studies according as it is a common, representative lab in a laboratory. Additionally, EPA is to EPA guidelines is always insect. (Ref. 36). EPA agrees that the proposing to add Anopheles albimanus recommended, but is not enough to Anopheles stephensi could be used for and A. stephensi. show that a foreign species is an testing, and has added Anopheles EPA agrees that Psorophora might be acceptable surrogate for a domestic stephensi to the list of species for reported in a field study. Even though species. However, the Agency mosquito testing in EPA’s proposal. this is another genus of mosquito, acknowledges that situations may arise Additionally, the SAP comments were Psorophora is not a major vector of where data showing efficacy of a much more extensive regarding diseases in the U.S. Other species may product against foreign species can be

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useful. Therefore, the Agency will The SAP suggested adding consistent with proposed 40 CFR consider bridging data from foreign Leptoconops kereszi complex and L. 158.1704. species to domestic species on a case- torrens (black gnats) to pest sub-group Initially proposed as ‘‘True bugs by-case basis. With this in mind, EPA is biting midges in the TSD. For claims (excluding bed bugs)’’ in the TSD, EPA seeking comment on whether other against biting midges, the Agency was is proposing to focus primarily on the species should be considered as part of proposing testing against one Culicoides two required test species, the conenose the required test species. species and one Leptoconops species. bug and the kissing bug. This proposal 13. Biting Flies. In proposed 40 CFR The specific species of Leptoconops has now separated them as pest-specific 158.1765, EPA is proposing data required are not specified; therefore claims since experience has shown that requirements for the pest group ‘‘Biting EPA would consider the species labeling and data are usually submitted flies (excluding Sand flies),’’ the pest suggested by the commenter with the intent of labeling for the sub-groups ‘‘Large Biting Flies’’ and (Leptoconops kereszi complex and L. specific pest. ‘‘Small Biting Flies (excluding Sand torrens) to be acceptable. The biting During the SAP, one commenter flies),’’ and nine pest-specific claims of midges pest sub-group has since been asked why the common stink bug biting flies. For the performance revised to be represented as the ‘‘Small species is missing from ‘‘true bugs.’’ standards, EPA is proposing standards Biting Flies (excluding Sand flies)’’ pest (Ref. 36). In response, the common stink consistent with proposed 40 CFR sub-group claim. Both biting midges and bug is not a disease vector or otherwise 158.1704. black gnats are listed separately under a pest of significant public health Since the SAP, the Agency has the pest-specific claims. importance, and therefore EPA did not revised the proposed data requirements 14. Bed Bugs. In proposed 40 CFR include it as a test species in the TSD to be clearer than initially presented to 158.1768, EPA is proposing data presented to the SAP. Since the ‘‘true the SAP. EPA proposed the pest group requirements for the pest group claim bug’’ claims have changed in this group, ‘‘Biting flies (excluding Sand flies)’’ to ‘‘Bed bugs’’ and pest-specific claims for stink bugs are no longer relevant to this be consistent with experience on how both the Common bed bug and the group. the Agency receives labeling requests. Tropical bed bug. For the performance Similarly, the SAP suggested that both Sand flies are vectors for Leishmaniasis, standards, EPA is proposing standards the conenose and the kissing bug be a parasitic disease that is found in parts consistent with proposed 40 CFR required test species. Both the kissing of the tropics, subtropics, and southern 158.1704. bug and the conenose bug (Triatoma Europe which can either cause skin For ‘‘Bed bugs,’’ one commenter protracta and Triatoma sanguisuga, sores or affect several internal organs indicated that only one species is respectively) are in the same genus and (usually spleen, liver, and bone important to the vast majority of are both vectors of Chagas disease. marrow). (Ref. 42). This differentiation consumers and thus only one species Given these similarities and to reduce improves the clarity and is consistent needs to be tested to support this kind the number of studies to be submitted, with how products have typically been of product registration. For this EPA did not believe it was necessary to labeled. proposal, EPA agrees that testing to require both when a ‘‘true bug’’ claim The Agency is also proposing to split include only the common bed bug, was still in consideration. Based on the pest sub-groups further into ‘‘Large Cimex lectularius, is appropriate as the experience, EPA has since opted to Biting Flies’’ and ‘‘Small Biting Flies lone required bed bug test species. propose that they be separate pest- (excluding Sand flies).’’ This is in In the TSD, the EPA initially specific claims. response to the fact that periodically, proposed a 95% performance standard 16. Ants (excluding carpenter ants). In the Agency receives requests for claims for bed bug products. One commenter the proposed 40 CFR 158.1776, the EPA against large biting flies or claims stated that the performance standard for is proposing data requirements for pest against small biting flies. This proposal bed bug control products that claim group ‘‘Ants (excluding carpenter is to provide that flexibility in the residual control and ovicidal control ants),’’ for the pest sub-groups ‘‘Fire and codified data requirements. should be 90% rather the 95% standard Harvester ants,’’ ‘‘Fire and Harvester ant During the SAP, the Panel suggested in the TSD. Additionally, the colonies,’’ and ‘‘Fire ants,’’ and for that the stable fly (Stomoxys calcitrans) commenter indicated that bed bug seven pest-specific claims in the and the horn fly (Haematobia irritans) products need to have residual activity, absences of a pest group or sub-group be included in the filth fly category. The because control of bed bugs is not claim. Panel also questioned why both species possible via direct contact. They For colony claims, testing must be need to be tested. In response, EPA indicated that there must be residual done specific to the species listed. For considers both the stable fly and the activity in order for the product to claim colony claims against the red and/or horn fly to be biting flies. The Agency ‘‘control’’ and if the product does not black imported fire ants, testing may be is proposing stable flies as one of the have residual activity, then this done on the red imported fire ant (RIFA) three representative species for the statement should be on the product (Solenopsis invicta), the black imported ‘‘Biting Fly (excluding sand flies)’’ pest label. The commenter also stated that a fire ant (Solenopsis richteri) or their group claim and one of the two required performance standard applicable to bed hybrid. test species the ‘‘Large Biting Flies’’ pest bug products that claim to kill bed bugs Data for the pharaoh ant sub-group claim. Testing of both species when bed bugs come into contact with (Monomorium pharaonis) and red as described in the TSD to obtain a a treated surface is needed. Therefore, imported fire ant (Solenopsis invicta) claim against stable flies was an error. EPA has decided to propose a would be required to support a general Instead, in the absence of an appropriate performance standard of 90%, instead of claim against ants, except carpenter pest group or pest sub-group the 95% in the TSD. ants. EPA proposes RIFA to receive a representation, the Agency is proposing 15. Conenose Bugs and Kissing Bugs. claim against fire and harvester ants for to require testing against stable flies for For proposed 40 CFR 158.1772, EPA is direct spray kill and residual surface a pest-specific efficacy claim against proposing data requirements for labeling application claims against foraging ants stable flies and testing against horn flies claims against conenose bugs and only (excluding colony claims). For bait for a pest-specific claim against horn kissing bugs. For the performance products or claims involving outdoor flies. standards, EPA is proposing standards use, testing must be specific to the

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

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requirements for the subterranean prevention of damage to wood’’ and and selection of test species. EPA termite, desert subterranean termite, thought that the lesser 95% or 90% generally expects to require product Formosan subterranean termite, would be more acceptable. EPA agrees performance data for invasive species drywood termite, and dampwood with the comment and is proposing a that are similar to the Asian longhorned termite. For products making a claim 95% prevention of damage to wood beetle and emerald ash borer in that against termites, EPA is proposing standard. However, EPA notes that what they have the potential to cause testing on species from four genera of constitutes a 95% standard is dependent significant economic or ecological termites. EPA is proposing to require on the type of study being performed. damage and the efficacy of products testing on: For example, for the standard U.S. used against them cannot readily be • Coptotermes formosanus Forest Service Concrete Slab field study, determined at the time of application. • And one of the following the 95% would be calculated such that This proposal specifies that the Asian Reticulitermes species: Reticulitermes any damage greater than nibbles to longhorned beetle and the emerald ash flavipes, or Reticulitermes hesperus, surface etching would be considered a borer are two invasive pests for which or Reticulitermes virginicus failure; if a single plot had more than product performance data must be • And one of the following arboreal one instance of nibbles to surface submitted. The efficacy of the products termite species: Nasutitermes coringer etching in any of the standard five used for their control typically cannot (Motschulsky) evaluation periods, this would also be a be determined until the season after • And one of the following drywood failure. A 95% success rate for the U.S. application, and the EPA believes it termite species: Cryptotermes brevis, Forest Service Concrete Slab (CS) tests appropriate to continue the practice of or Cryptotermes cavifrons, or would be determined by the combined reviewing efficacy data for these Incisitermes minor, or Incisitermes data for a product, by rate, in a given invasive species. snyderi year. For non-structural wood VIII. Updates to Subparts U and V preservative treatments, EPA is For a claim against arboreal termites, proposing a standard of 100% In addition to the inclusion of product EPA is proposing testing of one arboreal prevention of damage to wood for ≥2 performance data requirements under termite species: Nasutitermes coringer years. Additionally, to be consistent the new subpart R, EPA is also (Motschulsky). For a claim against with the majority of other pests, EPA is proposing to revise and update the dampwood termites, EPA is proposing proposing the termite standards for product performance data requirements testing of the following dampwood direct applications to pests, surface language for biochemical and microbial termite: Zootermopsis sp. For a claim applications, and spatial applications pesticides in subpart U, 40 CFR against drywood termites, EPA is will be changed to a performance 158.2070 and subpart V, 40 CFR proposing testing of one of the following standard of 90%, consistent with 158.2160, in order to clarify the drywood termites: Cryptotermes brevis, proposed 40 CFR 158.1704. requirements for products that would be or Cryptotermes cavifrons, or 21. Invasive Species. EPA believes subject to both proposed subpart R and Incisitermes minor or Incisitermes treating invasive species quickly and also subpart U or subpart V. snyderi. For a claim against appropriately is critical, and EPA does Subpart U (biochemical pesticides) subterranean termites, including not intend to preclude use of a pesticide and subpart V (microbial pesticides) formosan subterranean termites, EPA is product pursuant to FIFRA 2(ee) to treat currently require that product proposing testing in two genera of an invasive species. EPA believes that performance data be developed, and termites. Specifically, EPA is proposing pesticide products are an important tool that each applicant must ensure through testing on the following Coptotermes for managing the spread of an testing that the pesticide product is species: Coptotermes formosanus; and invertebrate invasive species and the efficacious when used in accordance one of the following Reticulitermes related public health concerns or with label directions and commonly species: Reticulitermes flavipes, or significant economic impacts. The accepted pest control practices. Both Reticulitermes hesperus, or availability of pesticide products with subparts also state that EPA may Reticulitermes virginicus. proven performance against an invasive require, on a case-by-case basis, For bait treatment, EPA is proposing species is important to slowing the submission of product performance data a performance standard of 95% spread of the invasive species. for any pesticide product registered or prevention of damage to wood for ≥3 Due to the sudden appearance and proposed for registration or amendment years. For ‘‘Non-Structural: Wood often rapid spread of invasive species, (see, 40 CFR 158.2070 and 40 CFR Preservative Treatment’’ EPA is except for the pests noted, EPA does not 158.2160). These requirements would proposing a 100% performance standard presently intend to list the specific not be modified by this proposal. of prevention of damage to wood for ≥2 invasive species for which product Subpart U (biochemical pesticides) years. And for structural protection, performance data might be deemed and subpart V (microbial pesticides) EPA is proposing a performance necessary. Instead, the submission of also currently require that product standard of 95% prevention of damage product performance data to support performance data be submitted for each to wood ≥5 years. claims for effectiveness against invasive biochemical and microbial pesticide The SAP suggested adding drywood invertebrate pests will be considered on product that bears a claim to control termite (Incisitermes synderi) as a test a case-by-case basis. Given the public health pests, as the term is used species. EPA is proposing to add expectation of infrequent submission of in subparts U and V. This requirement Incisitermes snyderi to the list of such an application, a ‘‘case-by-case’’ is followed by a non-exhaustive list of representative species for drywood approach is the most suitable. EPA public health pests. This includes pest termites. Additionally, Cryptotermes recommends that applicants consult microorganisms infectious to humans in cavifrons, a species endemic to Florida, with the Agency when first considering any area of the inanimate environment would also be an acceptable a submission to place an invasive or a claim to control vertebrates representative test species and EPA is species on the label of a pesticide (including but not limited to: Rodents, proposing to add this organism as well. product. As part of the consultation, birds, bats, canids, and skunks) or The SAP and other commenters EPA would be able to provide invertebrates (including but not limited questioned the standard of ‘‘100% information on protocol development to: Mosquitoes and ticks) that may

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directly or indirectly transmit diseases if the research involves intentional submitted to EPA for review and to humans. exposure of a human subject and if the evaluation before initiation of the study. This proposal adds additional clarity sponsor or investigator intends to The relevant information that must be by including a provision in subpart U submit the results of the research to EPA included in the proposed research (biochemical pesticides) and subpart V in connection with any action that may protocol is specified in 40 CFR 26.1125. (microbial pesticides) stating that be performed by EPA under the EPA then evaluates the protocol and product performance data must be pesticide laws (FIFRA or FFDCA), then makes a determination about the submitted for each product that bears a the research must comply with the scientific validity and reliability of the claim against an invertebrate pest that is provisions of 40 CFR part 26; the research as well as examining the covered by subpart R. This provision is requirements of EPA’s human studies ethical aspects of the research, in intended to be coextensive with the rule also apply to any research accordance with the conditions in 40 requirements of subpart R, and broader involving intentional exposure of a CFR 26.1603. EPA submits the protocol than the currently existing requirements human subject to a pesticide, when the and supporting materials, as well as in subparts U and V related to ‘‘public results are intended to be submitted in EPA’s science and ethics reviews of the health pests’’ in that it would also cover connection with a regulatory action proposed research to the HSRB for the wood-destroying beetles and under any other statute EPA review and comment. The members of invasive exotic species claims covered administers. In addition to establishing the HSRB review the proposed research. by subpart R. protections for human subjects of Then in an open and transparent Additionally, EPA notes that data research, EPA established the Human manner at a public meeting, members of requirements and the performance Studies Review Board (HSRB or Board) the HSRB ask additional questions, standards that determine the to review both proposals for new provide their individual comments, and acceptability of data may be modified research and reports of covered human participate in a discussion which is on a case-by-case pursuant to the research on which EPA proposes to rely documented in meeting minutes. Each provisions in 40 CFR 158.45 and 40 CFR under the pesticide laws. The HSRB is final HSRB report contains the Board’s 158.1707. a federal advisory committee operating responses to charge questions posed by in accordance with the Federal EPA, as well as the final, approved IX. Impact of This Proposal on Future Advisory Committee Act (FACA) (5 and Existing Registrations advice of the HSRB. The research U.S.C. app. 2, section 9). cannot be initiated until EPA approves This action, if finalized, will have no The HSRB typically includes the protocol, following its consideration immediate effect on existing independent experts in toxicology, of the HSRB’s input and registrations unless new information exposure assessment, industrial recommendations. The protocol will indicates an existing registration hygiene, statistics, and bioethics, as well only be approved if EPA determines that includes claims that are not sufficiently as an entomologist consultant. The the research conducted according to the supported. When an application for HSRB provides EPA with advice, protocol would meet the standards of 40 registration or amended registration information, and recommendations on CFR 26, Subparts K and L. Information requests to put a claim(s) on its issues related to both the scientific and on the HSRB, including materials pesticide product’s labeling for ethical aspects of human subjects reviewed and recommendations can be effectiveness against an invertebrate research. The major objectives are to found on the HSRB web page. (Ref. 44). species that is covered by this action, provide review and recommendations on the scientific and ethical aspects of Once the research has been the application would generally include conducted, then all of the records submission of product performance data research proposals and protocols, and reports of completed research with relevant to the research, including raw to support those claims for data and records of ethical review, are effectiveness. human subjects; and, when requested, advise on how to strengthen EPA’s submitted to EPA. EPA examines all X. Peer Review programs for protection of human submitted materials, considers the scientific and ethical conduct of the A. Human Studies Review Board subjects of research. EPA considers all recommendations from the HSRB before research, and provides the completed 1. Background. Research with human finalizing its reviews of proposed or research and its evaluation of the subjects that is conducted or supported final research. completed research to the HSRB. The by the U.S. government is subject to The HSRB reports to the EPA HSRB reviews the documents and regulations for the protection of human Administrator through EPA’s Science discusses them at a public meeting in subjects. These regulations are referred Advisor. Since 2006, the rigorous the same open and transparent manner. to as the Common Rule. EPA’s independent reviews conducted by EPA The HSRB issues a report of their codification of the Common Rule and the HSRB, as mandated by part 26, findings following the meeting. EPA appears at 40 CFR part 26, subpart A. have resulted in research protocols may rely on the results of completed On February 6, 2006 (71 FR 6138) (FRL– designed to result in scientifically- human research involving intentional 7759–8), EPA published a final rule sound data and to ensure the protection exposure of human subjects only if the amending part 26 by adding new of human subjects involved in the research meets the standards referenced subparts (B–Q). This amendment added, research. In providing for the in part 26, subpart Q. among other parts, Subpart K, which establishment of the HSRB, the 2. Review of EPA’s draft guideline applies standards similar to those in the regulations have reassured the public 810.3700. In October 2008, EPA Common Rule to third parties (i.e., those that all pesticide research involving presented to the HSRB a draft guideline other than federal agencies and intentional exposure to human subjects titled ‘‘Insect Repellents to be applied to federally-funded researchers) undergoes thorough independent and Human Skin’’ for review and evaluation. conducting research with human expert review based on scientific and (Ref. 46). The HSRB final report (Ref. subjects. Additional amendments to part ethical standards. 46) for that October 2008 meeting 26 have been made, most recently in Under 40 CFR part 26, subpart K, included the HSRB’s comments and 2019 (84 FR 35315, July 23, 2019) (FRL– protocols for research subject to the concerns about the statistical analysis 9996–48–ORD). Under EPA’s regulation, regulation’s requirements must be plan included in the draft guideline.

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Based on the HSRB review and proposal discusses how comments from their consideration and response comments, EPA revised the guideline the SAP and public comments informed scientific issues associated with and presented the revised guideline to the data requirements of proposed proposed revisions to two EPA Test the HSRB on June 23, 2010. EPA’s subpart R. Guidelines 810.3100 (Soil Treatment for Senior Policy Advisor for the Pesticide In separate actions EPA has Imported Fire Ants), and Guideline Program made a presentation titled, developed and revised testing 810.3500 (Premises Treatment), for Red ‘‘OPP Policy Decisions Regarding Insect guidelines and continues to do so. Imported Fire Ants (RIFA). These Repellent Efficacy Testing.’’ (Ref. 31). While this rule refers to these guidelines were originally published in The HSRB recommended several guidelines, and recommends their use, March 1998. changes or clarifications for the revised they are not the subject of today’s The proposed premises treatment guideline in its final report, (Ref. 47) proposal. For informational purposes, guideline revisions presented to the including: EPA is providing a description of SAP SAP contained recommended test • Removal of the maximum- meetings relevant to those guidelines. methodologies for a wide range of likelihood method requirement in the 1. 1994 meeting. In 1994, EPA held a products intended to kill, control, flush, data analysis section; 2-day meeting of the SAP to review the and/or knockdown invertebrate • Clarification of recommendations Agency’s proposed amendments to the premises pests, such as cockroaches, regarding the use of positive controls, data requirements for pesticide ticks, mosquitoes, flies, and wasps. The particularly with respect to the number registrations contained in 40 CFR part guideline did not cover treatment of of controls and the rationale for 158. The SAP was asked to comment on livestock or pets, wide area-mosquito including them in the study; each data requirement and identify, in control, or bed bug products. In addition • Careful consideration of their opinion, which ones were to guidance for testing efficacy of direct recommendations regarding the necessary to fully and thoroughly pesticide application to pests, residual recruitment and inclusion of so-called evaluate the potential hazard of a treatments, and cockroach and fly baits ‘vulnerable’ populations; and chemical compound and which ones in the laboratory, the proposed • Encouraging the use of study were not intrinsically useful in guideline also included field testing designs that will enable investigators to providing practical scientific methods for outdoor misting systems, collect data that will allow quantitative information. The review included both Hymenoptera nest treatments, and measurement of repellent efficacy in comparative product performance data outdoor foggers. Methods for resistance addition to determining the complete requirements along with product ratio determination and characterization protection time (CPT). performance data requirements for of pest population strain susceptibility On August 6, 2010 (75 FR 47592), public health and non-public health were also described. EPA announced the availability of the data requirements. A very complete The proposed RIFA treatment final guideline for Insect Repellents to discussion of the 1994 SAP was guideline revisions contained be Applied to Human Skin (Guideline presented in the proposed rule for recommended test methodologies for 810.3700). conventional pesticides (March 11, evaluating the performance of pesticide 3. Overall impact of HSRB review. As 2005; 70 FR 12310) (FRL–6811–2). products for the treatment and control required by 40 CFR part 26, the HSRB 2. April 2000 meeting. In April 2000 of red imported fire ant colonies/ has reviewed and commented on all the SAP was asked to comment on a mounds. The guideline did not cover protocols for conducting skin-applied draft guideline regarding insect premises treatments for RIFA workers/ insect repellents as well as the repellents for human skin and outdoor foragers, such as direct application to completed studies conducted according premises. (Ref. 48). pests. Field tests for both mound- and to those protocols. In its final reports, 3. July 2002 meeting. On July 30–31, area-applied pesticide products were the HSRB provided recommendations to 2002, the SAP was asked to review the proposed, along with accompanying strengthen EPA’s statistical approaches design and scientific soundness of the laboratory studies for baits, barrier for calculating CPTs. Additionally, the draft guideline entitled ‘‘Termite Bait treatments, and insect growth HSRB’s feedback has resulted in EPA’s Testing.’’ EPA’s presentations, the draft regulators. development of a model to calculate guideline, the charge questions, and the The meeting announcement, the sample sizes for field and lab testing Panel’s review of the guideline are Agency’s presentations and support with mosquitoes and lab testing with available at regulations.gov using the documents, and public comments are ticks, to support results. At the docket identifier EPA–HQ–OPP–2002– available at regulations.gov using the recommendation of the HSRB, EPA also 0125. docket identifier EPA–HQ–OPP–2017– elected not to require positive controls. 4. March 2012 meeting. On March 6– 0693. In September of 2019, EPA 7, 2012, EPA presented to the SAP, a published the final Product Performance B. FIFRA Scientific Advisory Panel draft guideline regarding bed bugs. The Test Guidelines OCSPP 810.3500: On March 19–20, 2013, EPA meeting announcement, the Agency’s Premises Treatments; Background presented to the SAP a variety of issues presentations and support documents, information, the draft guideline, and for their consideration and response public comments, and the comments by charge questions developed by EPA are concerning the Scientific Issues the SAP are available at regulations.gov available at https://archive.epa.gov/ Associated with Product Performance using the docket identifier EPA–HQ– scipoly/sap/meetings/web/html/ Data Needs for Pesticide Products OPP–2011–1017. After taking the SAP’s 040500_mtg.html. Claiming Efficacy against Invertebrate feedback into consideration, EPA 7. June 2019 meeting. On June 11–14, Pests of Significant Public Health or announced the availability of the final 2019, the SAP reviewed EPA’s proposed Economic Importance. The meeting test guideline, Laboratory Product guidelines for Efficacy Testing of announcement, the Agency’s Performance Testing Methods for Bed Topically Applied Pesticides Used presentations and support documents, Bug Pesticide Products; OCSPP Test Against Certain Ectoparasitic Pests on public comments, and the comments by Guideline 810.3900, on June 14, 2017 Pets. The meeting announcement, the the SAP are available at regulations.gov (82 FR 27254) (FRL–9959–78). Agency’s presentations and support using the docket identifier EPA–HQ– 5. May 2018 meeting. On May 8–10, documents, public comments, and the OPP–2012–0574. Unit VII of this 2018, EPA presented to the SAP for comments by the SAP are available at

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regulations.gov using the docket magnitude of the savings in discovery 11. US EPA. Office of Pesticide Programs, identifier EPA–HQ–OPP–20190161. costs discussed on page 29 of the cost Label Review Manual, available at analysis. https://www.epa.gov/pesticide- XI. Request for Comments registration/label-review-manual The Agency invites the public to XII. References (accessed March 13, 2020). 12. US EPA. Product Performance Guideline provide comment on the proposed The following is a listing of the 810.1000, Overview, Definitions, and requirements and their basis. documents that are specifically General Considerations, available at Specifically included within the referenced in this document. The docket https://www.epa.gov/test-guidelines- Agency’s requests for comments are includes these documents and other pesticides-and-toxic-substances/series- suggestions which can be supported by 810-product-performance-test-guidelines information considered by EPA, scientific data for the Agency to (accessed March 6, 2020). including documents that are referenced consider during the development of the 13. CDC. Division of Vector Borne Infectious within the documents that are included final rule. Specific comments are Diseases: West Nile Virus Fact Sheet in the docket, even if the referenced available at https://www.cdc.gov/ requested for: document is not physically located in westnile/resources/pdfs/wnvFactsheet_ 1. Definitions. The Agency welcomes 508.pdf, (accessed March 9, 2020). comment on the proposed definitions. the docket. For assistance in locating these other documents, please consult 14. CDC. Zika Virus, Statistics and Maps; The Agency also welcomes suggestions available at https://www.cdc.gov/zika/ FOR FURTHER on additional definitions that may be the person listed under reporting/index.html (accessed March 6, needed to help clarify what is required INFORMATION CONTACT. 2020); CDC, Zika Virus, available at in the regulations. 1. US EPA. Cost Analysis of the Proposed https://www.cdc.gov/zika/index.html 2. Representative test species. The Product Performance Rule, prepared by (accessed March 6, 2020). proposed rule includes taxonomic the Biological and Economic Analysis 15. CDC. Lyme Disease: Data and categories of invertebrates which require Division, Office of Pesticide Programs, Surveillance, available at https:// www.cdc.gov/lyme/datasurveillance/ more than one species to be tested to available in docket: EPA–HQ–OPP– _ _ 2020–0124. index.html?CDC AA support a general claim for that pest refVal=https%3A%2F%2Fwww.cdc.gov group. The representative taxa were 2. US EPA. Pesticide Registration (PR Notice) Notice 2002–1, available at https:// %2Flyme%2Fstats%2Findex.html selected on the basis of vigor of the pest www.epa.gov/sites/production/files/ (accessed March 19, 2020). species and the likely ability of the 2014-04/documents/pr2002-1.pdf at 2 16. M.L. Wilson, J.F. Levine, and A. Spielman. Effect of deer reduction on species to serve as an adequate surrogate (accessed March 6, 2020); see also Public abundance of the deer tick (Ixodes for other pests in the group. The Review Draft: Pesticide Registration (PR dammini), Yale J Biol Med. 1984 Jul– selection of representative taxa was Notice) 2020–[X], Draft List of Pests of Aug; 57(4): 697–705. Significant Public Health Importance— informed by the 2013 SAP. 17. David Cameron Duffy, Scott R. Campbell, 3. Performance standards. The Revised 2020, docket EPA–HQ–OPP– Dara Clark, Chris Dimotta, Susan Agency welcomes specific comments on 2020–0260. Gurney. Ixodes scapularis (Acari: performance standards. The Agency 3. US EPA. PRN 96–7 Termiticide Labeling, Ixodidae) Deer Tick Mesoscale would need to see scientifically sound available at https://www.epa.gov/ Populations in Natural Areas: Effects of pesticide-registration/prn-96-7- Deer, Area, and Location, Journal of data to support any recommendations termiticide-labeling (accessed March 13, for performance standards that differ Medical Entomology, Volume 31, Issue 2020). 1, 1 January 1994, Pages 152–158, from those proposed. The Agency 4. United States Public Health Service. Public believes requiring data showing the https://doi.org/10.1093/jmedent/ Health Report. 1923 Aug 3; 38(31): 1747– 31.1.152. pesticide meets a specified threshold 1814. 18. CDC. Lyme Disease: Treatment, available level (performance standard) of efficacy 5. Scott, Thomas and Willem Takken. at https://www.cdc.gov/lyme/treatment/ is the best means of addressing potential Feeding strategies of anthropophilic index.html (accessed March 6, 2020). consequences which could occur mosquitoes result in increased risk of 19. CDC. Signs and Symptoms of Untreated through the use of ineffective pesticides pathogen transmission. Trends in Lyme Disease, available at http:// Parasitology March 2012, Vol. 28, No. 3. intended for use against pests that www.cdc.gov/lyme/signs_symptoms/ 6. Eisen, Lars. Pathogen transmission in index.html (accessed March 9, 2020). transmit disease. relation to duration of attachment by 4. Economic analysis. The Agency 20. CDC. Rocky Mountain Spotted Fever: Ixodes scapularis ticks, Ticks and Tick- Signs and Symptoms, available at also welcomes public comment on its borne Diseases. https://www.cdc.gov/rmsf/symptoms/ economic analysis of the proposed rule, 7. US EPA. Bed Bugs, Get them out and Keep index.html, (accessed March 6, 2020); as well as on its underlying them Out, available at https:// CDC. assumptions, economic data, and high www.epa.gov/bedbugs (accessed March 21. CDC. Rocky Mountain Spotted Fever: and low-cost options and alternatives. 6, 2020). Information for Health Care Providers, Describe any assumptions and provide 8. US EPA and CDC. Joint statement on bed available at https://www.cdc.gov/rmsf/ any technical information and data used bug control in the United States from the healthcare-providers/index.html U.S. Centers for Disease Control and in preparing your comments. Explain (accessed March 6, 2020). Prevention (CDC) and the U.S. 22. CDC. Lyme Disease: Preventing Tick Bites estimates in sufficient detail to allow for Environmental Protection Agency (EPA); on People, available at https:// it to be reproduced for validation. EPA’s available at https://stacks.cdc.gov/view/ www.cdc.gov/lyme/prev/on_people.html underlying principle in developing the cdc/21750/Email (accessed March 19, (accessed March 6, 2020). proposed revisions has been to strike an 2020). 23. CDC. Division of Vector Borne Infectious appropriate balance between the need 9. Su N–Y, Scheffrahn RH (2000). Termites Diseases: West Nile Virus (WNV) Fact for adequate data to make the statutorily as pests of buildings. In: Abe T, Bignell Sheet available at https://www.cdc.gov/ mandated determinations and informed DE, Higashi M (eds) Termites: Evolution, westnile/resources/pdfs/wnvFactsheet_ risk management decisions, while sociality, symbioses, ecology. Kluwer, 508.pdf (accessed March 6, 2020). Boston, pp 437–453. minimizing data collection burdens on 24. Emerald Ash Borer Information Network, 10. Peterson CJ, Wagner TL, Shelton TG, available at http:// regulated community required to Mulrooney JE (2008). A historic pest: 90 www.emeraldashborer.info/about- support product performance data years of USDA publications reveal eab.php (accessed March 9, 2020). requirements. In particular, EPA would changes in termite management. Pest 25. USDA. Emerald Ash Borer, available at appreciate public comment on the Manag Prof 76(2):25, 28–30, 32. https://www.aphis.usda.gov/aphis/

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ourfocus/planthealth/plant-pest-and- screwworms--selections-fr/introduction found at https://www.epa.gov/laws- disease-programs/pests-and-diseases/ (accessed March 9). regulations/laws-and-executive-orders. emerald-ash-borer (accessed March 9, 39. US EPA. EPA’s Guideline 810.3700, 2020). entitled, ‘‘Insect Repellents to be A. Executive Order 12866: Regulatory 26. USDA. Asian Long-Horned Beetle, Applied to Human Skin,’’ available at Planning and Review and Executive available at https:// https://www.epa.gov/test-guidelines- Order 13563: Improving Regulations www.invasivespeciesinfo.gov/profile/ pesticides-and-toxic-substances/series- and Regulatory Review asian-long-horned-beetle, (accessed 810-product-performance-test-guidelines March 9, 2020). (accessed July 1, 2020). This action is a significant regulatory 27. NRS. Economic Impacts of Non-Native 40. Comment submitted by Dudley Hoskins, action that was submitted to the Office Forest Insects in the Continental United Responsible Industry for a Sound of Management and Budget (OMB) for States, available at https:// Environment, March 10, 2013, EPA–HQ– review under Executive Orders 12866 www.nrs.fs.fed.us/pubs/38719 (accessed OPP–2012–0574–0009. (58 FR 51735, October 4, 1993) and March 9, 2020). 41. Comment submitted by Beth Law, 13563 (76 FR 3821, January 21, 2011). 28. US EPA. Technical Support Document Consumer and Specialty Products Any changes made in response to OMB Scientific Issues Associated with Product Association, March 15, 2013, EPA–HQ– recommendations have been Performance Data Needs for Pesticide OPP–2012–0574–0014. documented in the docket. EPA Products Claiming Efficacy against 42. CDC. Parasites-Leishmaniasis, available at Invertebrate Pests of Significant Public https://www.cdc.gov/parasites/ prepared an analysis of the potential Health or Economic Importance leishmaniasis/index.html (accessed costs and benefits associated with this Submitted to the FIFRA Scientific March 16, 2020). action (Ref. 1) which is summarized in Advisory Panel for Review and Comment 43. Comment submitted by Brian Forschler, more detail in Unit I.E. This analysis is March 19–21, 2013 (Hereinafter ‘‘TSD’’), Termiticide Scientific Review Panel, available in the docket. available in docket: EPA–HQ–OPP– March 19, 2013, EPA–HQ–OPP–2012– 2012–0574–0002, Appendix 1, Tables I 0574–0016. B. Paperwork Reduction Act (PRA) and II. 44. US EPA. Science Adviser Programs: The information collection activities 29. US EPA. FIFRA Scientific Advisory Human Studies Review Board, available in this proposed rule have been Panel, Meeting Minutes and Final Report at https://www.epa.gov/osa/human- submitted for approval to OMB under for the March 19–21, 2013 Scientific studies-review-board (accessed April 1, Advisory Panel, available at https:// the PRA, 44 U.S.C. 3501 et seq. The 2010). Information Collection Request (ICR) www.epa.gov/sites/production/files/ 45. US EPA. Draft Guideline 810.3700, Insect 2015-06/documents/031913minutes.pdf Repellents to be applied to Human Skin document that EPA prepared is assigned (accessed April 9, 2020). https://archive.epa.gov/osa/hsrb/web/ EPA ICR No. 0277.20 and OMB Control 30. World Health Organization (WHO). pdf/guidelines-for-performance-testing- No.: 2070–0060 (Ref. 49). You can find Guidelines for Efficacy Testing of of-skin-applied-insect-repellents- a copy of the ICR in the docket and it Mosquito Repellents for Human Skin, 9.23.08.pdf (accessed April 1, 2020). is briefly summarized here. available at http://whqlibdoc.who.int/hq/ 46. US EPA. October 21–22, 2008 EPA The information collection activities _ _ _ _ 2009/WHO HTM NTD WHOPES Human Studies Review Board Meeting _ in this proposed rule are associated with 2009.4 eng.pdf (accessed March 23, Report, available at https:// the codification of efficacy data 2020). archive.epa.gov/osa/hsrb/web/pdf/ 31. US EPA. OPP Policy Decisions Regarding requirements against certain october2008hsrbb invertebrate pests. These information Insect Repellent Efficacy Testing, finaldraftreport12808.pdf (accessed (prepared for June 23, 2010, Human April 9, 2020). collection activities are activities Subjects Research Board Meeting). 47. US EPA. EPA Human Studies Review associated with the application for a 32. USDA. National Invasive Species Board Meeting Report, June 23, 2010. new or amended registration of a Information Center, available at https:// Available at https://archive.epa.gov/osa/ pesticide and are currently approved by www.invasivespeciesinfo.gov/ (accessed hsrb/web/pdf/june2010 OMB under OMB Control No. 2070– April 29, 2020). finalreport090910.pdf (accessed April 0060 (EPA ICR No. 0277). As such, this 33. Consumer and Specialty Products 14, 2020). ICR is intended to amend that existing Association (CSPA). Comment submitted 48. US EPA. Background Information, the by Beth Law, CSPA, March 15, 2013, ICR at the final rule stage, incorporating Draft Guideline, and Charge Questions the information collection activities EPA–HQ–OPP–2012–0574–0014. Developed by EPA, available at https:// 34. USDA. Victor Borne Diseases: Cattle archive.epa.gov/scipoly/sap/meetings/ attributable to this proposed rule, Fever Ticks, available at https:// web/html/040500_mtg.html. including a reduction in transaction www.aphis.usda.gov/aphis/ourfocus/ 49. US EPA. ‘‘Proposed Rule-related ICR costs associated with a clear animalhealth/animal-disease- Amendment for Pesticide Product codification of the product performance information/cattle-disease-information/ Performance Data Requirements for data requirements for certain cattle-vector-borne-diseases (accessed Products Claiming Efficacy Against invertebrate pests. March 9, 2020). Certain Invertebrate Pests’’ (RIN 2070– Respondents/affected entities: There 35. Bovine Babesiosis, available at AJ49), EPA ICR No.: 0277.20 and OMB are three groups impacted by the rule. cfsph.iastate.edu/factsheets/pdfs/ Control No.: 2070-[tbd]. November 2020. bovine_babesiosis.pdf (accessed March Chemical producers (NAICS 32532), 24, 2020). XIII. FIFRA Review Requirements colleges, universities, and professional 36. S.C. Johnson & Son, Inc. Comment schools (NAICS code 611310), and submitted by Jill Geyser, S.C. Johnson & Pursuant to FIFRA section 25(a), EPA research and development labs and Son, Inc., March 9, 2013, EPA–HQ–OPP– submitted the draft proposed rule to the services (NAICS code 541712). 2012–0574–0011. Secretary of Agriculture (USDA) and the Respondent’s obligation to respond: 37. UF IFAS. Featured Creatures: Human Bot FIFRA SAP for review. A draft of the These data must be submitted for the Fly, available at http:// proposed rule was also submitted to the applicant to receive the desired entnemdept.ufl.edu/creatures/misc/flies/ appropriate Congressional Committees. pesticide registration or label claim. human_bot_fly.htm (accessed March 9, 2020). XIV. Statutory and Executive Order Authorizing legislation is contained in 38. USDA. National Agricultural Library, Reviews Section 3 of FIFRA (7 U.S.C. 136). The New World Screwworms, available at implementing regulations specific to the https://www.nal.usda.gov/exhibits/ Additional information about these product performance data requirements speccoll/exhibits/show/stop- statutes and Executive Orders can be are contained in 40 CFR part 158.

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Estimated number of respondents: the beginning of this rule. You may also species pests, equivalent to about EPA estimates that registrants submit 60 send your ICR-related comments to $17,000 in savings per data package data packages to the Agency annually OMB’s Office of Information and submitted to the Agency and about for efficacy review. Some registrants Regulatory Affairs via email to OIRA_ $5,500 per registrant in annual savings may submit multiple data packages per [email protected], Attention: I have therefore concluded that this year. Under this rule the number of Desk Officer for the EPA. action will relieve regulatory burden for submissions may decline—and therefore C. Regulatory Flexibility Act (RFA) all directly regulated small entities. The the number of respondents may also basis for this determination is presented decrease. I certify that this action will not have in the small entity analysis prepared as Frequency of response: On occasion. a significant economic impact on a part of the cost analysis for the proposed Total estimated burden: The proposed substantial number of small entities rule (Ref. 1), which is summarized in rule is expected to reduce burden hours under the RFA, 5 U.S.C. 601 et seq. In Unit I.E, and a copy is available in the by 4,683 annually, including 4,515 making this determination, the impact docket for this rulemaking. We have hours from reduced paperwork burden of concern is any significant adverse therefore concluded that this action will associated with data generation and 168 economic impact on small entities. An relieve regulatory burden for all directly hours from reduced paperwork burden agency may certify that a rule will not regulated small entities. associated with the application process. have a significant economic impact on Burden is defined at 5 CFR 1320.3(b). a substantial number of small entities if D. Unfunded Mandates Reform Act EPA already accounts for the activities the rule relieves regulatory burden, has (UMRA) associated with the proposed rule in the no net burden, or otherwise has a This action does not contain an currently approved ICR, which covers positive economic effect on the small unfunded mandate as described in most activities associated with new and entities subject to the rule. EPA’s small UMRA, 2 U.S.C. 1531–1538, and will entity analysis suggests that the greatest amended registrations; EPA estimates a not significantly or uniquely affect small impact, and the most potential cost total annual respondent burden of 1.5 governments. The action imposes no savings, would accrue to small entities million hours for all these activities. As enforceable duty on any state, local or discussed in the Proposed Rule-related and new registrants. While large, tribal governments. The proposed rule ICR Amendment (Ref. 49), 483,000 of established registrants have experience would primarily affect the private those hours are paperwork burden from with the registration process and are sector, i.e., pesticide registrants. The data generation for new products, and aware of EPA’s data requirements or rule is not expected to result in 102,000 of those hours are paperwork have the means to determine the expenditures by State, local, and Tribal burden from application for new and appropriate studies, new and small governments, in the aggregate, or by the amended products. registrants without that experience may Total estimated cost: The estimated bear significant costs of acquiring this private sector, of $100 million or more burden reduction is expected to reduce information. The registrants would have (when adjusted annually for inflation) burden cost by $330,000 annually, easier access to the data requirements, in any one year. Accordingly, this including $315,000 from reduced and the reduction in information proposed rule is not subject to the paperwork burden associated with data acquisition costs would be largest for requirements of sections 202, 203, or generation and $15,000 from reduced those registrants with the greatest 205 of UMRA. The cost analysis for this paperwork burden associated with the information acquisition needs. Thus, action is summarized in Unit I.E. and is application process, which includes $0 EPA anticipates that the proposed rule available in the docket. annualized capital or operation and would result in cost savings, E. Executive Order 13132: Federalism maintenance costs. EPA already particularly for small and first-time accounts for the activities associated registrants. While the affected NAICS This action does not have federalism with the proposed rule in the currently codes contain up to 5,438 small entities, implications as specified in Executive approved ICR, which covers most EPA does not expect all entities to Order 13132 (64 FR 43255, August 10, activities associated with new and experience cost savings in all years as a 1999), because it will not have amended registrations; EPA estimates a result of this proposed rule. As the cost substantial direct effects on the states, total annual respondent burden of $109 analysis (Ref. 1) describes, a sample of on the relationship between the national million for all these activities. As 30 applications was selected at random. government and the states, or on the discussed in the Proposed Rule ICR These applications were submitted by distribution of power and (Ref. 49), $33.7 million of that cost is 16 different firms, four of which EPA responsibilities among the various paperwork burden from data generation was able to identify as small businesses levels of government. for new products, and $9.3 million of according to the Small Business F. Executive Order 13175: Consultation that cost is paperwork burden from Administration Employees or Revenue and Coordination With Indian Tribal application for new and amended Thresholds. About 60 packages are Governments products. received annually by EPA for control An agency may not conduct or claims. Therefore, EPA expects that, on This action does not have tribal sponsor, and a person is not required to average, approximately ten small implications as specified in Executive respond to, a collection of information entities will experience cost savings Order 13175 (65 FR 67249, November 9, unless it displays a currently valid OMB each year as a result of this proposed 2000), because it will not have control number. The OMB control rule. substantial direct effects on tribal numbers for EPA’s regulations in 40 While not every element of the governments, on the relationship CFR are listed in 40 CFR part 9. proposed rule would result in savings between the Federal government and Submit your comments on the for registrants, EPA conservatively the Indian tribes, or on the distribution Agency’s need for this information, the estimates that the rule would result in of power and responsibilities between accuracy of the provided burden $1 million in annual reductions in the Federal government and Indian estimates and any suggested methods registrant expenditures on the process of tribes. At present, no Tribal for minimizing respondent burden to receiving label claims against public governments hold, or have applied for, the EPA using the docket identified at health, wood destroying, and invasive a pesticide registration. Thus, Executive

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Order 13175 does not apply to this agricultural and non-agricultural, 158.1748 Keds, screwworms, and bot flies. action. pesticides and pests, reporting and 158.1752 Filth flies. recordkeeping requirements. 158.1756 Mosquitoes. G. Executive Order 13045: Protection of 158.1760 Biting flies. Children From Environmental Health Jane Nishida, 158.1768 Bed bugs. Risks and Safety Risks Acting Administrator. 158.1772 Conenose bugs and kissing bugs. 158.1776 Ants (excluding carpenter ants). EPA interprets Executive Order 13045 For the reasons set forth in the 158.1780 Bees, wasps, yellowjackets, and (62 FR 19885, April 23, 1997) as preamble, EPA proposes to amend 40 hornets. applying only to those regulatory CFR part 158 as follows: 158.1782 Carpenter ants. actions that concern environmental 158.1784 Wood-destroying beetles. health or safety risks that the EPA has PART 158—DATA REQUIREMENTS 158.1786 Termites. reason to believe may FOR PESTICIDES disproportionately affect children, per Subpart R—Product Performance for ■ the definition of ‘‘covered regulatory 1. The authority citation for part 158 Products Claiming Effectiveness action’’ in section 2–202 of the continues to read as follows: Against Invertebrate Pests Authority: 7 U.S.C. 136–136y; 21 U.S.C. Executive Order. This action is not § 158.1700 General requirements. subject to Executive Order 13045 346a. (a) General. Each applicant must because it does not concern an ■ 2. In § 158.1, revise paragraph (c) to environmental health risk or safety risk. ensure through testing that their product read as follows: is efficacious when used in accordance H. Executive Order 13211: Actions § 158.1 Purpose and scope. with label directions and commonly Concerning Regulations That * * * * * accepted pest control practices. The Significantly Affect Energy Supply, (c) Scope of individual subparts. (1) Agency may require, as specified herein Distribution or Use Conventional pesticides. Subparts A, B, and on a case-by-case basis, submission This action is not a ‘‘significant C, D, E, F, G, K, L, N, O, and R apply of product performance data for any energy action’’ as defined in Executive to conventional pesticides. pesticide product registered or proposed Order 13211 (66 FR 28355, May 22, (2) Biochemical pesticides. Subparts for registration or amendment. 2001) because it is not likely to have a A, B, E, R, and U apply to biochemical (1) Test substance. All product significant adverse effect on the supply, pesticides. performance testing is performed using distribution or use of energy and has not (3) Microbial pesticides. Subparts A, the end-use product. otherwise been designated as a B, E, R, and V apply to microbial (2) Test organism. All product significant energy action by the pesticides. performance testing must report the Administrator of the Office of (4) Antimicrobial pesticides. Subparts species tested. Information and Regulatory Affairs. A, B, C, D, E, R, and W of this part apply (3) Testing. All products are to be to antimicrobial pesticides. tested to support the claim(s) made on I. National Technology Transfer ■ 3. Revise the heading for subpart E to the labeling of the pesticide product. Advancement Act (NTTAA) read as follows: (4) Data requirements. To determine This action does not involve technical the specific product performance data standards that would require Agency Subpart E—Product Performance for required to support the registration of consideration under NTTAA section Products Claiming Effectiveness each pesticide product, the applicant 12(d), 15 U.S.C. 272. Against Vertebrate Pests, Products must refer to the applicable sections of With Prion-related Claims, and this subpart. J. Executive Order 12898: Federal Products for Control of Organisms (b) Product performance data Actions To Address Environmental Producing Mycotoxins submission. Each product that bears a Justice in Minority Populations and claim subject to this subpart, must be Low-Income Populations ■ 4. Add section subpart R to read as follows: supported by submission of product The EPA believes that this action is performance data, as listed in this not subject to Executive Order 12898 (59 Subpart R—Product Performance for subpart. This product performance data FR 7629, February 16, 1994) because it Products Claiming Effectiveness Against must be submitted with any application does not establish an environmental Invertebrate Pests for registration or amended registration. health or safety standard. The Agency Sec. For the pest-specific claims listed in this notes, however, that the proposed data 158.1700 General requirements. subpart, data must be for the species requirements will provide data that will 158.1701 Definitions. specified to support the claim. be used to assure that pesticide products 158.1703 Application categories. 158.1704 Performance standards for data § 158.1701 Definitions. perform effectively if claiming acceptability. effectiveness against an invertebrate 158.1705 Test guidelines. Definitions. The following terms are pest of significant public health or 158.1707 Data requirement modifications. defined for purposes of this subpart. economic importance, and to address 158.1708 Invasive species claims. Complete protection time (CPT) both health concerns and economic 158.1709 Invertebrate disease vector claims. means the time from application of a consequences stemming from pesticide 158.1710 Structural and wood-destroying skin-applied insect repellent until products that might not perform as pest claims. efficacy failure, which is described in claimed on the label, including 158.1712 Mites (excluding chiggers). Product Performance Test Guideline consequences for sensitive 158.1714 Chiggers. 810.3700—Insect Repellents to be 158.1718 Ticks. Applied to Human Skin. subpopulations and minority or low- 158.1722 Scorpions. income communities. 158.1726 Spiders. Introduction means the intentional or unintentional escape, release, Lists of Subjects in 40 CFR Part 158 158.1732 Centipedes. 158.1736 Lice. dissemination, or placement of a species Environmental protection, 158.1740 Fleas. into an ecosystem as a result of human administrative practice and procedure, 158.1744 Cockroaches. activity.

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Invasive species means with respect § 158.1703 Application categories. intentional exposure of human subjects. to a particular ecosystem, any species The following terms are defined for Protocols for such testing must be that is not native to that ecosystem, and purposes of this subpart. submitted to EPA for review prior to whose introduction does or is likely to Bait treatment means a pesticide study initiation. Those protocols cause economic or environmental harm product intended to be ingested by the determined by EPA to involve or harm to human health. target pest that kills or controls an intentional exposure of human subjects Performance standard means a invertebrate pest such as ants, also require review by EPA’s Human benchmark or reference against which cockroaches, or termites. This is Studies Review Board (HSRB)) prior to the efficacy of the pesticide is compared normally through the insect feeding on study initiation. If you are uncertain (including, but not limited to, the ability the product directly, but may also about the applicability of the 40 CFR of the pesticide product to control, kill, include products which the target will part 26 requirements to this 40 CFR part or repel an invertebrate pest species). contact and later ingest during 158 testing requirement or uncertain Pest group labeling claim means a grooming/cleaning. The attractiveness of about the nature of your planned testing claim or statement on the labeling of the these products is through the use of a (such as, for example, whether the pesticide product that the product is palatable food base, however they may testing would involve intentional effective against a group of related also incorporate an attractant (e.g. exposure of human subjects or whether species or taxa demonstrating adequate pheromone) which is intended to attract the testing would be an observational similarity in basic biology and life the target pests over a greater distance. study), you should contact the Agency history characteristics to permit Soil-applied termiticides means prior to initiating the testing. identification of representative test pesticide products that are applied to (c) Labeling claims for products other species for the entire assemblage of taxa. the soil beneath and/or adjacent to the than skin-applied insect repellents. Pest-specific labeling claim means a structure, pre- or post-construction, to Unless otherwise specified in claim or statement on the labeling of the kill or control termites. Treatments can §§ 158.1710 through 158.1786, for pesticide product that the product is be preventive (i.e., to provide structural pesticides other than skin-applied insect effective against a particular arthropod protection before a termite infestation is repellents, the performance standard for species, such as German cockroach or present) or remedial (i.e., to kill and a product performance claim against a house fly. control a termite infestation when pest must be greater than or equal to 90 Pest sub-group labeling claim means a present). percent, except for non-wearable spatial claim or statement on the labeling of the Spatial repellents include treatments repellents where the performance pesticide product that the product is of both indoor and outdoor sites where standard is greater than or equal to 75 effective against a set of related species the product is applied into the air rather percent. or taxa demonstrating adequate than onto a surface or the skin in order similarity in basic biology and life to drive away insects or other § 158.1705 Test guidelines. history characteristics to permit arthropods from that space. They are EPA has published the Harmonized identification of representative test intended to repel the target pest through Test Guidelines, which set forth the species and part of a larger identified the dispersal of pesticide into the recommended approach to generate the taxonomic grouping (e.g., Biting flies) atmosphere of a room or other open data required in this subpart. The that includes other pest species, which space. Product Performance Guidelines (Series may or may not have a proposed pest Structural protection means the 810, Group C—Invertebrate Control group. prevention of termite or other wood- Agent Test Guidelines) are available on Skin-applied insect repellent means a destroying pest activity in an entire the Agency’s website. These guidelines product intended to disrupt the host- structure as the result of an application cover some, but not all, of the tests that seeking behavior of insects or other of a pesticide product. would be used to generate data under arthropods, driving or keeping them this subpart. In instances where there is away from treated human skin. The § 158.1704 Performance standards for data a conflict between one of the repellent product, such as liquid, lotion, acceptability. Harmonized Test Guidelines and the or spray, is intended to be applied (a) General. The claim stated on the provisions of this subpart, this subpart directly to human skin. Efficacy of skin- pesticide product labeling (such as will control. applied insect repellents is expressed as knockdown, control, mortality, or complete protection time. repellency) determines the performance § 158.1707 Data requirement Species means a group of organisms standard that must be met. In the modifications. all of which have a high degree of absence of specific pest/labeling claims/ The data requirements (including the physical and genetic similarity, performance standards specified in performance standards associated with generally interbreed only among §§ 158.1708 through 158.1799, the the data requirements) specified in this themselves, and show persistent performance standards of paragraphs (b) subpart as applicable to a category of differences from members of allied and (c) of this section apply. products will not always be appropriate groups of organisms. (b) Skin-applied insect repellent for every product in that category. Data Wood-destroying applies to pests that labeling claims. (1) For skin-applied requirements may, on a case-by-case feed on or nest in wood, and therefore insect repellent labeling claims, the basis, be adjusted by EPA in response to are highly destructive to wood buildings performance standard must be greater requests for novel technologies or or structures, and stored lumber. The than or equal to 2-hours complete products that have unusual physical, impact on the structural integrity of protection time. chemical, or biological properties or buildings can represent significant (2) Any testing required under this atypical use patterns which would make economic or safety concerns given the part which involves any human subjects a particular data requirement, or data costs of remediation. must comply with all applicable performance standard, inappropriate. Vector means any organism capable of requirements under 40 CFR part 26. For Requests for such data requirement transmitting the causative agent of example, 40 CFR part 26 requirements modifications must be submitted the human and/or animal disease, including are pertinent to the part 158 testing same manner as waiver requests but not limited to mosquitoes and ticks. requirement if the testing involves submitted under 40 CFR 158.45. EPA

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will respond in writing to those or Asian longhorned beetle, claim specific to a structural or wood- requests. The Agency may modify data Anoplophora glabripennis, must be destroying pest not identified in requirements it finds are inappropriate accompanied by product performance §§ 158.1782 through 158.1786, EPA may for the pesticide in question, but will data to support those claims for require submission of product ensure that sufficient data are available effectiveness. performance data, with testing on that to make the determinations required by specific pest and subject to specific the applicable statutory standards. § 158.1709 Invertebrate disease vector performance standards, to support those claims. claims for effectiveness. § 158.1708 Invasive species claims. If an application for registration or (a) General. In addition to those amended registration requests a labeling § 158.1712 Mites (excluding chiggers). species specified in paragraph (b) of this claim specific to a disease vector (such (a) General. The tables and test notes section, if an application for registration as repels mosquitoes that may carry in this section apply to dust, human itch or amended registration requests a West Nile virus), then submission of or scabies, and dog follicle mites. The labeling claim for effectiveness against testing conducted with the species claim stated on the pesticide product an invasive invertebrate species, then on specific to the disease vector claim and labeling determines the required test a case-by-case basis, EPA may require subject to specific performance species. The required test species for a submission of product performance data standards is required even if the test specific type of mite claim appear in and establish performance standards for species is not specifically required in paragraph (b) of this section and the those data to support those claims for §§ 158.1712 through 158.1786. required performance standards appear effectiveness. in paragraph (c) of this section. (b) Specific. Applications for § 158.1710 Structural and wood-destroying (b) Test species. For pesticide registration or amended registration pest claims. products making a claim against mites, requests for a labeling claim for the If an application for registration or the required test species appear in the emerald ash borer, Agrilus planipennis, amended registration requests a labeling following table.

TABLE 1 PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST MITES [Excluding Chiggers]

Labeling claim Required test species

Dog Follicle Mite ...... Dog follicle mite (Demodex canis). Dust Mite ...... Testing on one of the following species is required: American house dust mite (Dermatophagoides farinae) OR European house dust mite (Dermatophagoides pteronyssinus). Human Itch or Scabies Mite ...... Human itch mite (Sarcoptes scabiei).

(c) Performance standards. (1) For the § 158.1718 Ticks. specific species of ‘‘ticks’’ that dog follicle mite, a performance (a) General. The table and test notes individual species and all the listed standard of 100 percent is required. in this section apply to hard ticks representative species for ‘‘ticks’’ must (2) For the human itch or scabies (including cattle ticks) and soft ticks. be tested, but not the representative mite, a performance standard of 100 species for cattle ticks or soft ticks. percent is required. The claim stated on the pesticide product labeling determines the Claims against ticks in association with § 158.1714 Chiggers. required test species. The required test tick borne diseases are also subject to If the pesticide product labeling species for a specific type of tick claim the requirements in § 158.1709. makes a claim against chiggers, then appear in paragraph (b) of this section. (b) Test species. For pesticide testing is required using the following Specific parameters that apply to products making a claim against ticks, test species: Chigger (Trombicula individual tests appear in paragraph (c) the required test species appear in the alfreddugesi). of this section. For a claim against any 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 American dog tick (Dermacentor tick (Ixodes scapularis), Lone star tick parameters are required. variabilis), and Brown dog tick (Amblyomma americanum), and 1. For products applied to dogs, (Rhipicephalus sanguineus). American dog tick (Dermacentor testing is required on three species: 2. For products applied to cats, testing variabilis). Blacklegged tick (Ixodes scapularis), is required on three species: Blacklegged

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§ 158.1722 Scorpions. § 158.1726 Spiders. spider labeling claims appear in If the pesticide product labeling (a) General. The table in this section paragraph (b) of this section. makes a claim against scorpions, then applies to spiders. The product labeling (b) Test species. For products making testing is required using the following a claim against spiders, the test species claim determines the required test test species: Striped bark scorpion for labeling claims appear in the species. The required test species for (Centruroides vittatus). following table.

TABLE 1 OF 158.1726—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST SPIDERS

Labeling claim Required test species

Pest Group Claim

Spiders ...... Testing on two species is required: Brown recluse spider (Loxosceles reclusa) AND one of the following species is required: Northern black widow spider (Latrodectus variolus) OR Southern black widow spider (Latrodectus mactans) OR Western black widow spider (Latrodectus hesperus).

Pest Sub-Group Claims

Black Widow Spiders ...... Testing on one of the following species is required: Northern black widow spider (Latrodectus variolus) OR Southern black widow spider (Latrodectus mactans) OR Western black widow spider (Latrodectus hesperus).

Pest-Specific Claims

Brown recluse spider ...... Brown recluse spider (Loxosceles reclusa). Brown widow spider ...... Brown widow spider (Latrodectus geometricus). Northern black widow spider ...... Northern black widow spider (Latrodectus variolus). Southern black widow spider ...... Southern black widow spider (Latrodectus mactans). Western black widow spider ...... Western black widow spider (Latrodectus hesperus).

§ 158.1732 Centipedes. test species. The required test species (b) Test species. For products making (a) General. The table in this section for a labeling claim appears in a claim against centipedes, the required applies to centipedes. The product paragraph (b) of the section. test species for a labeling claim is set labeling claim determines the required forth in the following table.

TABLE 1 OF 158.1732—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST CENTIPEDES

Labeling claim Required test species

Centipedes ...... Testing on one of the following species is required: House centipede (Scutigera coleoptrata) OR Florida blue centipede (Hemiscolopendra marginata) OR Scolopendra sp.

§ 158.1736 Lice. for a labeling claim appears in (b) Test species. For products making (a) General. The table in this section paragraph (b) of this section. The a claim against lice, the required test applies to human lice. The product required performance standards appear species for a labeling claim appear in labeling claim determines the required in paragraph (c) of this section. the following table. test species. The required test species

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 § 158.1740 Fleas. labeling claim appears in paragraph (b) labeling claims against lice, a (a) General. The table in this section of this section. (b) Test species. For products making performance standard of 100 percent is applies to fleas. The product labeling a claim against fleas, the required test required. claim determines the required test species for a labeling claim is set forth species. The required test species for a in the following table.

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TABLE 1 OF 158.1740—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST FLEAS

Labeling claim Required test species

Pest Group Claim

Fleas ...... Testing on the following species is required:

Cat flea (Ctenocephalides felis)

Pest-Specific Claims

Cat flea ...... Cat flea (Ctenocephalides felis). Chigoe flea ...... Chigoe flea (Tunga penetrans). Dog flea ...... Dog Flea (Ctenocephalides canis). Hen flea ...... Hen flea (Ceratophyllus gallinae). Human flea ...... Human flea (Pulex irritans). Oriental rat flea ...... Oriental rat flea (Xenopsylla cheopis).

§ 158.1744 Cockroaches. paragraph (b) of this section. Specific required test species for a labeling claim (a) General. The table in this section parameters that apply to individual tests for cockroaches and the test species for applies to cockroaches. The product and labeling claims appear in paragraph pest-specific label claims appear in the labeling claim determines the required (c) of this section. following table. test species. The required test species (b) Test species. For products making for a labeling claim appears in a claim against cockroaches, the

TABLE 1 OF 158.1744—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST COCKROACHES

Labeling claim Required test species

Pest Group Claims

Cockroaches ...... Testing on two species is required: American cockroach (Periplaneta americana) AND German cockroach (Blattella germanica).

Pest-Specific Claims

American cockroach ...... American cockroach (Periplaneta americana). Australian cockroach ...... Australian cockroach (Periplaneta australasiae). Brown cockroach ...... Brown cockroach (Periplaneta brunnea). Brownbanded cockroach ...... Brownbanded cockroach (Supella longipalpa). German cockroach ...... German cockroach (Blattella germanica). Oriental cockroach ...... Oriental cockroach (Blatta orientalis). Smokybrown cockroach ...... Smokybrown cockroach (Periplaneta fuliginosa). Turkestan cockroach ...... Turkestan cockroach (Blatta lateralis).

§ 158.1748 Keds, screwworms, and bot determines the required test species. (b) Test species. For products making flies. The required test species for labeling a claim against keds, screwworms, and (a) General. The table in this section claims appear in paragraph (b) of this bot flies, the required test species for a applies to keds, screwworms, and bot section. labeling claim appear in the following flies. The product labeling claim table.

TABLE 1 OF 158.1748—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST KEDS, SCREWWORMS, AND BOT FLIES

Labeling claim Required test species

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

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

TABLE 1 OF 158.1752—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST FILTH FLIES

Labeling claim Required test species

Pest Group Claim

Filth Flies ...... Testing on two species is required: House fly (Musca domestica). AND one of the following species is required: Flesh fly (Sarcophaga sp., Wohlfahrtia sp., and other genera of flesh flies) OR Blow fly (Phaenicia sp., Calliphora sp., and other genera of blow flies).

Pest-Specific Claims

Blow fly ...... Blow fly (Phaenicia sp., Calliphora sp., and other genera of blow flies). Cluster fly ...... Cluster fly (Pollenia rudis). Face fly ...... Face fly (Musca autumnalis). Flesh fly ...... Flesh fly (Sarcophaga sp., Wohlfahrtia sp., and other genera of flesh flies). House fly ...... House fly (Musca domestica). Little house fly ...... Little house fly (Fannia canicularis).

§ 158.1756 Mosquitoes. any specific species of mosquito, that (b) Test species. For products making (a) General. The tables and test notes individual species and all the required a claim against mosquitoes, the required in this section apply to mosquitoes. The test genera must be tested. Claims test species for a labeling claim is set required test species for a labeling claim against mosquitos in association with forth in the following table. against mosquitoes appears in paragraph mosquito-borne diseases are also subject (b) of this section. For a claim against to the requirements in § 158.1709.

TABLE 1 OF 158.1756—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST MOSQUITOES

Labeling claim Required test species

Mosquitoes ...... Testing in three genera (Culex, Aedes, and Anopheles) of mosquitoes is required. One of the following Culex species: Culex pipiens OR Culex quinquefasciatus OR Culex tarsalis AND one of the following Aedes species: Aedes aegypti OR Aedes albopictus AND one of the following Anopheles species: Anopheles albimanus OR Anopheles freeborni OR Anopheles gambiae OR Anopheles punctipennis OR Anopheles quadrimaculatus OR Anopheles stephensi.

§ 158.1760 Biting flies. required test species. The required test (b) Test species. For products making (a) General. The tables in this section species for biting fly labeling claims and a claim against biting flies, the required apply to biting flies, which includes the test species for pest-specific labeling test species for a labeling claim and the biting midges and black flies. The claims appear in paragraphs (b) of this test species for pest-specific label claims product labeling claim determines the section. appear in the following table.

TABLE 1 OF 158.1760—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST BITING FLIES

Labeling claim Required test species

Pest Group Claim

Biting flies (excluding Sand flies) .... Testing is required on three species: Stable fly (Stomoxys calcitrans). AND one of the large biting fly species: Black horse fly (Tabanus atratus) OR Deer fly (Chrysops sp.) OR Striped horse fly (Tabanus lineola). AND one of the small biting fly species: Biting midge (punkie, granny nipper, no-see-um) (any Culicoides sp.) OR Black fly (any Simulium sp. or Prosimulium sp.) OR Black gnat (any Leptoconops sp.).

Pest Sub-Group Claims

Large Biting Flies ...... Testing is required on two species: Stable fly (Stomoxys calcitrans). AND one of the following species: Black horse fly (Tabanus atratus) OR Deer fly (Chrysops sp.) OR Striped horse fly (Tabanus lineola).

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TABLE 1 OF 158.1760—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST BITING FLIES—Continued

Labeling claim Required test species

Small Biting Flies (excluding Sand Testing is required on one of the following species: flies). Biting midge (punkie, granny nipper, no-see-um) (Culicoides sp.) OR Black fly (Simulium sp. OR Prosimulium sp.) OR Black gnat (Leptoconops sp.).

Pest-Specific Claims

Biting midges (punkie, granny nip- Biting midge (punkie, granny nipper, no-see-um) (Culicoides sp.). per, no-see-um). 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).

§ 158.1768 Bed bugs. test species. The required test species (b) Test species. For products making (a) General. The table in this section for a labeling claim appears in a claim against bed bugs, the required applies to bed bugs. The product paragraph (b) of this section. test species for a labeling claim appear labeling claim determines the required in the following table.

TABLE 1 OF 158.1768—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST BED BUGS

Labeling claim Required test species

Pest Group Claim

Bed bugs ...... Common bed bug (Cimex lectularius).

Pest-Specific Claims

Common bed bug ...... Common bed bug (Cimex lectularius). Tropical bed bug ...... Tropical bed bug (Cimex hemipterus).

§ 158.1772 Conenose bugs and kissing determines the required test species. (b) Test species. For products making bugs. The required test species for a labeling a claim against either the conenose and/ (a) General. The table in this section claim appears in paragraph (b) of this or kissing bugs, the required test species applies to Conenose bugs and Kissing section. for a labeling claim is set forth in the bugs. The product labeling claim following table.

TABLE 1 OF 158.1772—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM CONENOSE AND KISSING BUGS

Labeling claim Required test species

Conenose bug ...... Conenose bug (Triatoma sanguisuga). Kissing bug ...... Kissing bug (Triatoma protracta).

§ 158.1776 Ants (excluding carpenter The required test species for labeling labeling claim appear in the following ants). claims appear in paragraph (b) of this table, unless otherwise specified in (a) General. The table in this section section. paragraphs (c) or (d) of this section. applies to ants (excluding carpenter Test species. For products making a ants). The product labeling claim claim against ants (excluding carpenter determines the required test species. ants), the required test species for a

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TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST ANTS [Excluding Carpenter Ants]

Labeling claim Required test species

Pest Group Claim

Ants (excluding carpenter ants) ...... Testing is required on the following two species: Pharaoh ant (Monomorium pharaonis) AND Red imported fire ant (Solenopsis invicta).

XPest Sub-Group Claim

Fire and Harvester ...... Testing is required on the following species: Red imported fire ant (Solenopsis invicta). Fire ants ...... Testing is required on the following species: Red imported fire ant (Solenopsis invicta).

Pest-Specific Claims

European fire ant ...... European fire ant (Myrmica rubra). Harvester ant ...... Harvester ant (Pogonomyrmex sp.). Pharaoh ant ...... Pharaoh ant (Monomorium pharaonis). Red imported fire ant ...... Red imported fire ant (Solenopsis invicta). Southern fire ant ...... Southern fire ant (Solenopsis xyloni). Tropical fire ant ...... Tropical fire ant (Solenopsis geminata). Black imported fire ant ...... Black imported fire ant (Solenopsis richteri).

(c) Colony Claims. For colony claims, only (excluding colony claims). For bait The required test species for labeling testing must be done specific to the products or claims involving outdoor claims appear in paragraph (b) of this species listed. For colony claims against use, testing must be specific to the section. the red and/or black imported fire ants, species listed. (b) Test species. For products making testing may be done on, S. invicta, S. a claim against bees, wasps, richteri, or their hybrid. § 158.1780 Bees, wasps, yellowjackets, (d) Bait products or claims involving and hornets. yellowjackets, and hornets, the required outdoor use. The group and sub-group (a) General. The table in this section test species for a labeling claim appear claims in paragraph (b) of this section applies to bees, wasps, yellowjackets, in the following table, unless otherwise are for direct kill and residual surface and hornets. The labeling claim specified in paragraph (c) of this application claims against foraging ants determines the required test species. section.

TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST BEES, WASPS, YELLOWJACKETS, AND HORNETS

Labeling claim Required test species

Pest Group Claims

Bees, Wasps, Yellowjackets, and Testing on three species is required: Hornets. 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, specific species. Colony claims against for labeling claims appear in paragraph except Vespula spp., testing must be Vespula spp. have a performance (b) of this section. The required specific to the species listed. Acceptable standard of 100%. performance standards appear in data for any Vespula species may § 158.1782 Carpenter ants. paragraph (c) of this section. support a yellowjacket colony claim for (a) General. The table in this section (b) Test species. For products making ground nesting Vespula species; applies to carpenter ants. The product a claim against carpenter ants, the however, species-specific claims need to labeling claim determines the required required test species for a labeling claim be supported by data from testing of the test species. The required test species appear in the following table.

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

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

Application category Performance standard

Bait Treatment ...... 95% prevention of damage to wood for ≥3 years. Non-Structural: Wood Preservative 100% prevention of damage to wood for ≥2 years. Treatment. Structural Protection ...... 95% prevention of damage to wood ≥5 years.

§ 158.1784 Wood-destroying beetles. test species for a labeling claim appears (b) Test species. For products making (a) General. The tables and test notes in paragraph (b) of this section. The a claim against wood-destroying beetles, in this section apply to wood-destroying required performance standards appear the required test species for a labeling beetles. The labeling claim determines in paragraph (c) of this section. claim is set forth in the following table. the required test species. The required

TABLE 1 TO PARAGRAPH (b)—REQUIRED TEST SPECIES FOR PRODUCTS MAKING A CLAIM AGAINST WOOD-DESTROYING BEETLES

Labeling claim Required test species

True powderpost beetles ...... Testing on one species from the Lyctinae subfamily is required. Wood-destroying or wood-boring Testing on three species is required: beetles. Anobiid beetle (Anobiidae sp.) AND Bostrichid beetle (Bostrichidae sp.) AND Old house borer (Hylotrupes bajulus).

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

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

Application category Performance standard

Bait Treatment ...... 95% prevention of damage to wood ≥3 years. Non-Structural: Wood Preservative 100% prevention of damage to wood for ≥2 years. Treatment. Structural Protection ...... 95% prevention of damage to wood ≥5 years.

§ 158.1786 Termites. termite. The labeling claim determines (b) Test species. For products making (a) General. The tables and test notes the required test species. The required a claim against termites, the required in this section apply to the subterranean test species for labeling claims appear in test species for a labeling claim appear termite, desert subterranean termite, paragraph (b) of this section. The in the following table. Formosan subterranean termite, required performance standards appear drywood termite, and dampwood in paragraph (c) of this section.

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:

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

Labeling claim Required test species

Reticulitermes flavipes OR Reticulitermes hesperus OR Reticulitermes virginicus AND one of the following arboreal termite species: Nasutitermes coringer (Motschulsky) AND one of the following drywood termite species: Cryptotermes brevis OR Cryptotermes cavifrons OR Incisitermes minor OR Incisitermes snyderi.

Pest Sub-Group Claim

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

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

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

Application category Performance standard

Bait Treatment ...... 95% prevention of damage to wood ≥3 years. Non-Structural: Wood Preservative 100% Prevention of damage to wood for ≥2 years. Treatment. Structural Protection ...... 95% prevention of damage to wood ≥5 years.

■ 5. Revise § 158.2070 to read as performance standards that determine Agency may require, on a case-by-case follows: the acceptability of data may be basis, submission of product modified on a case-by-case basis performance data for any pesticide § 158.2070 Biochemical pesticides product pursuant to the waiver provisions in 40 product registered or proposed for performance data requirements. CFR 158.45 and the provisions in 40 registration or amendment. (a) General. Product performance data CFR 158.1707. must be developed for all biochemical (b) Product performance data for each (c) Product performance data for each product that bears a claim against an pesticides. Each applicant must ensure product that bears a public health through testing that the product is invertebrate pest that is covered by claim, excluding those covered under subpart R of this part. The product efficacious when used in accordance paragraph (b). Product performance with label directions and commonly performance data requirements of data must be submitted with any subpart R of this part apply to microbial accepted pest control practices. The application for registration or amended Agency may require, on a case-by-case products covered by this subpart. registration, if the product bears a claim Product performance data must be basis, submission of product to control public health pests, such as performance data for any pesticide submitted with any application for pest microorganisms infectious to registration or amended registration. product registered or proposed for humans in any area of the inanimate registration or amendment. However, data requirements and the environment, or a claim to control performance standards that determine (b) Product performance data for each vertebrates, including but not limited to, product that bears a claim against an the acceptability of data may be rodents, birds, bats, canids, and skunks. modified on a case-by-case basis invertebrate pest that is covered by ■ 6. Revise § 158.2160 to read as pursuant to the waiver provisions in 40 subpart R of this part. The product follows: performance data requirements of CFR 158.45 and the provisions in 40 subpart R of this part apply to § 158.2160 Microbial pesticides product CFR 158.1707. biochemical products covered by this performance data requirements. (c) Product performance data for each subpart. Product performance data must (a) General. Product performance data product that bears a public health be submitted with any application for must be developed for all microbial claim, excluding those covered under registration or amended registration. pesticides. Each applicant must ensure paragraph (b). Product performance The performance standards required in through testing that the product is data must be submitted with any subpart R of this part also apply to efficacious when used in accordance application for registration or amended biochemical pesticide products. with label directions and commonly registration, if the product bears a claim However, data requirements and the accepted pest control practices. The to control public health pests, such as

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pest microorganisms infectious to § 158.2200 Applicability. uses and claims, and to the humans in any area of the inanimate * * * * * requirements of this subpart with environment, or a claim to control (b) A product that bears both respect to its antimicrobial uses and vertebrates, including but not limited to, antimicrobial and non-antimicrobial claims. rodents, birds, bats, canids, and skunks. uses or claims is subject to the data * * * * * requirements for pesticides in subparts ■ 7. In § 158.2200, revise paragraph (b) [FR Doc. 2021–05137 Filed 3–19–21; 8:45 am] C through O, R, and U or V of this part to read as follows: BILLING CODE 6560–50–P with respect to its non-antimicrobial

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