                         Response to Comments Document
         Pesticide Product Performance Data Requirements Proposed Rule
                                  March 2022

On March 22, 2021, the Environmental Protection Agency's Office of Pesticide Programs (OPP) published a proposed rule entitled "Pesticide Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests." EPA proposed to codify the product performance data requirements for invertebrate pests that would need to be submitted to EPA to support labeling claims on a registered pesticide product. For products making claims against pests covered by proposed 40 CFR part 158 subpart R, the efficacy data would be submitted to EPA for review and evaluation as part of the application for registration. For products not making claims subject to subpart R, the efficacy data would be held in the applicant's files and submitted to EPA if there were concerns about the efficacy of the product and EPA requested the information for immediate submission.

EPA received 16 unique public comments on the proposal. These included comments from industry, non-governmental organizations, trade associations, state governments, consultants, and others. The public comments are available in Docket Number: EPA-HQ-OPP-2020-0124. 

The commenters (with docket identifier) included:
 Abacus Consulting (Docket ID EPA-HQ-OPP-2020-0124-0002)
 Association of Structural Pest Control Regulatory Officials (ASPCRO) (Docket ID EPA-HQ-OPP-2020-0124-0068) (comment document and MOU)
 BASF Corporation (Docket ID EPA-HQ-OPP-2020-0124-0066)
 Brassard Pesticide Regulatory Solutions LLC (Docket ID EPA-HQ-OPP-2020-0124-0071)
 Candace and David Brassard (Docket ID EPA-HQ-OPP-2020-0124-0073)
 Douglas Products (Docket ID EPA-HQ-OPP-2020-0124-0062)
 Household & Commercial Products Association (Docket ID EPA-HQ-OPP-2020-0124-0067)
 Joshua Kerzhner (Docket ID EPA-HQ-OPP-2020-0124-0060)
 National Pest Management Association (Docket ID EPA-HQ-OPP-2020-0124-0065)
 People for the Ethical Treatment of Animals (Docket ID EPA-HQ-OPP-2020-0124-0063)
 Responsible Industry for a Sound Environment (Docket ID EPA-HQ-OPP-2020-0124-0072)
 Syngenta Crop Protection LLC (Docket ID EPA-HQ-OPP-2020-0124-0064)
 Treated Wood Council (TWC) (Docket ID EPA-HQ-OPP-2020-0124-0061)
 Tyler Barnhart (Docket ID EPA-HQ-OPP-2020-0124-0059)
 Viance LLC (Docket ID EPA-HQ-OPP-2020-0124-0070)
 Wood Preservative Science Council (Docket ID EPA-HQ-OPP-2020-0124-0069)

EPA considered the public comments during the development of a final rule entitled, "Product Performance Data Requirements for Products Claiming Efficacy Against Certain Invertebrate Pests." In several instances, EPA made adjustments to the provisions of the rule based on feedback from public comments. Unit VII of the preamble of the final rule provides a description of how EPA considered public comments and the changes that were made to the final rule. This Response to Comments Document supplements the discussion in Unit IV of the preamble to the final rule. This document does not always cross-reference each response with each commenter(s) who raised a particular issue. However, in many cases where commenters provided particularly detailed comments that were used to frame EPA's overall response on an issue, those individual commenters are paraphrased. The responses presented in this document are intended to augment discussion that appears in the preamble to the final rule. Although portions of the preamble to the final rule are paraphrased in this document, to the extent such paraphrasing introduces any confusion or apparent inconsistency, the preamble itself remains the definitive statement of the rationale for the provisions included in the final rule. 
For this Response to Comments Document, EPA has only addressed comments directly applicable to the final rulemaking. Comments that were out-of-scope of the rulemaking were noted, but not addressed, in the document and may be used by EPA in developing science policies, revising the guidelines, or future rulemakings, as appropriate.
This Response to Comments Document is organized into the following topic areas: 

Unit 1: General Comments 
Unit 2: Comments Related to the Inclusion of Pests
      Species-specific Comments
      Pest Group Comments 
Unit 3: Performance Standards
Unit 4: Definitions
Unit 5: Invasive Species
Unit 6: Miscellaneous 
Unit 7: Representative Test Species
Unit 8: Guidelines/Guidance

Unit 1: General Comments

Comment 1-1: One commenter wrote that they were supportive of science-based data driven standards for product efficacy that will expedite decision making and reduce bureaucratic hurdles in the registration process. They believe in clear guidance on procedures for bringing the tools necessary to control public health, wood destroying, and invasive pests to market while providing flexibility for new formulations and technologies is vital. They encouraged the Agency to work closely with registrants and other stakeholders to continue to refine these data requirements. They also encouraged the Agency to engage and work closely with its state regulatory partners through the existing Memorandum of Understanding (MOU) between the Agency and the ASPCO and its Termiticide Label Review Committee (TLRC) and Termiticide Standards Committee (TSC). They also encouraged the Agency to maintain flexibility for registrants who intend to bring novel non-termite management technologies to market which may not easily conform to the existing product performance data guidelines published by EPA. Additionally, increased flexibility may be required when new invasive pests threaten public health, structures, food, or the environment, requiring the need for bridging of efficacy data or utilization of general pest claims to allow for rapid response to emergency situations. Ultimately, the Agency should periodically review and update the proposed guidelines with the input of stakeholder and subject matter experts to ensure that the guidelines are providing the most effective and efficient model for efficacy testing. 

      EPA's Response: Thank you for your comment. EPA notes that the regulations have provisions that allow waiver or modification of the product performance data requirements in situations where they are inappropriate for a particular product (40 CFR 158.30, 158.45, 158.1707). Data requirements may, on a case-by-case basis, be modified by EPA in response to requests for novel technologies or products that have unusual physical, chemical, or biological properties or atypical use patterns which would make a particular data requirement, or data performance standard, inappropriate. 
      
      To the extent the commenter is raising issues with EPA's Series 810 - Product Performance Test Guidelines, those guidelines are outside the scope of this rule. 

Comment 1-2: One commenter shared a concern that while it is understandable that an argument is to be made that a diluted product could be more cost-effective, if EPA codifies this performance/label claim relation, it is in fact discouraging deception to the product user. The balance between the health for human standards and the environment must be considered. This would be considered an all-around win. The commenter would like the Agency to consider that the importance of ensuring pesticide concentrations and resulting efficacy data is transparent between the manufacturer and user in order to attain the highest possible human health standards. 

      EPA's Response: Thank you for your comment. One of the benefits of codification is that it provides increased transparency to users regarding the efficacy data that typically needs to be submitted. 

Comment 1-3: One commenter shared their support for the proposed rule because verifying efficacy claims holds pesticide companies accountable and lowers their production costs, as well as making consumers feel safer about the food they purchase. The commenter would like to make one major change to this rule, and that is instead of companies voluntarily submitting their data packages for efficacy review, it should be mandatory. While the concern for products submitted to potentially decrease, this should not be a concern if EPA made it mandatory for all pesticides. Currently the Agency is working with "high-stake" products (e.g., ticks, mosquitoes, cockroaches, etc.), wood-destroying insects (e.g., termites), and certain invasive invertebrate species (e.g., Asian longhorned beetle). While this list is a "narrow set of pesticides" they are the type of products that must work effectively. 

The commenter also suggested that the EPA standard, "To ensure that labeling provides consumers with accurate information concerning how long and how well the product works, EPA reviews and evaluates product (efficacy) data," be expanded to include fertilizers and other products.

The commenter mentioned that the only opposition they see occurring against this proposed rule is from companies that currently rely on the Agency's loose guidelines for pesticide labeling and marketing and can "specifically get away with making claims based on cheaper testing that may not be up-to-standard." If the Agency does not pass this proposed rule, "they would believe the independent testing of approved high-stake pesticides, which effectively assumes that pesticides are safe until proven otherwise."

      EPA's Response: Thank you for your comment and your general support of the rule. The rule would require product performance data for pesticides intended for use against invertebrate pests of significant public health importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-destroying insects (e.g., termites), and certain invasive invertebrate species (e.g., Asian longhorned beetle), which is consistent with EPA's current practices to review efficacy data for these pests. EPA generally does not require that product performance data be submitted in support of claims against pests that are not pests of significant public health or economic importance. However, even if these data do not need to be submitted to EPA, the applicant is required to have efficacy data on file for all labeled pests, as per 40 CFR §158.400(e) note 1.
      
      To the extent the commenter is requesting that the rule be expanded to cover products that are fertilizers in addition to pesticides, fertilizers are outside the scope of this rule. EPA proposed product performance data requirements for the invertebrate pests described above, and EPA is not expanding the scope of the final rule. 
      
Unit 2: Comments Related to the Inclusion of Pests 

Species-specific Comments
Comment 2-1: One commenter believed that the mammalian-parasitic nematodes, e.g., skin-penetrating human threadworm Strongyloides stercoralis and hookworms Necator americanus and Ancylostoma caninum could be considered for inclusion. 

      EPA's Response: Products intended and labeled for use against mammalian-parasitic nematodes in or on humans are considered human drugs subject to regulation by the Food and Drug Administration and are excluded from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (40 CFR 152.6(c)). Additionally, even assuming a product is not intended and labeled for use to address nematodes in or on humans, the mammalian-parasitic nematodes are not included in the categories of pests covered by this rulemaking. However, even though these efficacy data do not need to be submitted to EPA, an applicant for registration of a pesticide is required to have efficacy data on file for all labeled pests, as per 40 CFR §158.400(e) note 1, and EPA may request submission of that data on a case-by-case basis. 
      
Comment 2-2: One commenter stated that it would be helpful to add the invertebrate pests of honeybees to the list of pests that the regulation applies to. Beekeeping is not a major industry in terms of dollar sales, but it is very important as a support for many significant crops, and invertebrate pests are the main challenge faced by beekeepers. Varroa mite (Varroa destructor Anderson and Trueman), Small hive beetle (Aethina tumida Murray) and Tracheal mite (Acarapis woodi, Rennie) are significant pests, and there are a number of other pests that could be considered.

      EPA's Response: While EPA agrees that beekeeping provides an important support for many significant crops, agricultural pests are generally outside the scope of this rulemaking. Thus, EPA did not propose, and is not finalizing, provisions specific to pests of honeybees. This rule is intended to codify existing practices in relation to the types of pest problems identified. This rule includes three categories of invertebrate pests: pests of significant public health importance (e.g., ticks, mosquitoes, cockroaches, etc.), wood-destroying insects (e.g., termites), and certain invasive invertebrate species (e.g., Asian longhorned beetle). However, even if the data do not need to be submitted to EPA, the applicant is required to have efficacy data on file for all labeled pests, as per 40 CFR §158.400(e) note 1, and EPA may, on a case-by-case basis, require that data to be submitted, e.g., for other similarly situated invasive exotic species. 
      
Comment 2-3: One commenter had concerns about the inclusion of certain requirements for specific pests within the proposed requirements. They added that it is important that EPA finalize efficacy standards that recognize common challenges in collecting test individuals and in testing pest species within a laboratory environment. They asked EPA to make accommodations for these challenges when appropriate.

Two commenters recommended removing Nasutitermes corniger as a required test species for a general termite claim, since it is only found in a small area of the United States. They added that the Florida Department of Agriculture and Consumer Services has an active eradication program for this species, so obtaining individuals for laboratory testing would be extremely difficult and ill advised. Conducting field tests of candidate formulations within the quarantine area while eradication projects continue would negate long-standing eradication efforts. 

A commenter also recommended revisiting the criteria used in the U.S. Forest Service concrete Slab field study given the development of modern non-repellent chemistries. As referenced in the document, the "Gulfport" scale makes a distinction between surface etching (1 rating) and penetration (2 rating). Whether termites respond by removing material from the surface of the wood or by tunneling is unpredictable, and observations of either behavior do not necessarily indicate product failure, especially for non-repellent chemistries. Some level of damage is expected when using non-repellent chemistries, and etching or penetration may occur in one year, even on multiple replicates, but never reoccur in subsequent years. If there are no repeated attacks, a single incidence of etching or penetration for any given replicate should not be considered failure. 

      EPA's Response: Regarding the request to remove Nasutitermes corniger as a required test species for a general termite claim since it is only found in a small area of the U.S., this species is only required for a general (all termites) or specific (Nasutitermes spp.) termite claim. Testing of Nasutitermes corniger is not required to support claims against Subterranean or Drywood termites. Furthermore, there are locations within the U.S. other than Florida (i.e., U.S. territories) that have this species for conducting tests.
      Regarding the recommendation to revisit the criteria used in the U.S. Forest Service concrete slab field study given the development of modern non-repellent chemistries, the Agency asserts that no level of damage should be expected. This is distinct from light surface etching, which does not include any penetration into the wood. Light surface etching may occur without being considered a product failure for non-repellent products. However, any activity on the bait/wood would constitute a failure for repellent termiticides, as it is an indicator that the repellent barrier was ineffective. 

Comment 2-4: Two commenters recommended allowing any widow spider species to qualify as a test species for a black widow claim. The proposed requirements only list three species of black widow spider (Latrodectus variolus, Latrodectus mactans, and Latrodectus hesperus) as test species to make a black widow spider claim. The brown widow (Latrodectus geometricus), for example, is more prevalent in some regions of the U.S., and individuals of this species would be easier to obtain for testing. They believe the brown widow should be an alternate test species for a black widow claim on the basis of this greater availability. 

      EPA's Response: Regarding the request to allow for testing of the brown widow spider to support all widow spider claims (including black widows), while the Agency agrees that the brown widow has an extensive range in the Southern U.S., the black widow spider is better suited to be the representative test species. Compared to brown widows, black widow spiders have larger bodies and a greater life expectancy. For efficacy testing, hardier species are often selected as the representative species. Furthermore, from a public health perspective, the brown widow spider is less aggressive, and the bite is less severe than that of black widow spiders. 
      
Comment 2-5: A commenter wrote that the proposed requirements list Rhipicephalus microplus and Rhipicephalus annulatus as test species for cattle ticks. The commenter stated that this species is only available for testing from three laboratories within the U.S., two of which are operated by the U.S. Department of Agriculture (USDA). Limited laboratory availability could result in a monopoly on testing within the United States. To accommodate this, we encourage EPA to accept data generated outside the U.S. as long as it is conducted according to good laboratory practice (GLP) or Organization for Economic Co-operation and Development guidelines.

Another commenter similarly requested changing the required test species, Cattle fever tick, because it is difficult to obtain and not widely available in testing labs. Changing this required test species would result in the more readily available Southern cattle ticks being the required test species for a cattle ticks labeling claim. Conversely, if cattle fever ticks remain a required test species for a cattle ticks labeling claim, the commenter requested that the Agency provide clarity on how registrants can more readily perform this efficacy study as this species of tick is not readily available.

      EPA's Response: Claims for cattle ticks require testing one of the two listed species, not both, therefore EPA did not make any changes.
      
      Regarding the request to allow for Rhipicephalus microplus and Rhipicephalus annulatus data to be generated outside of the U.S. due to lack of availability in U.S. laboratories, this may be acceptable on a case-by-case basis, depending on the type of test being performed. The Agency can be consulted prior to testing commencement. 

Comment 2-6: The commenter wrote that the Old house borer (Hylotrupes bajulus) is listed as a required test species to make claims against wood-destroying or wood-boring beetles. Hylotrupes bajulus is found in limited geographies across the U.S. and is very difficult to acquire. In order to obtain Hylotrupes bajulus for testing, researchers often must pull larvae out of the wood, which requires opening many logs, making it difficult to obtain a suitable sample size. Removing larvae from their habitat inside the wood also introduces another variable into the study that can affect their fitness and possibly mortality during testing. For these reasons, they recommended removing this species as a requirement for wood-destroying and wood-boring beetle claims. 

      EPA's Response: EPA is maintaining the Old house borer (Hylotrupes bajulus) as one of three required representative test species to make claims against wood-destroying or wood-boring beetles. EPA agrees that it is not appropriate to attempt to extract these larvae from wood and test them in the laboratory. It is more appropriate to test them under field conditions. While these may not be readily available for laboratory testing, they can and should be tested in field. EPA has received data on Old house borer and notes that data from field tests are typically provided for this claim.

Comment 2-7: Two commenters recommended adding an option to test the Arizona bark scorpion (Centrurioides sculpturatus) as an alternative to Centruroides vittatus. Though Centrurioides sculpturatus is slenderer than Centruroides vittatus, its sting can have a greater adverse medical impact than Centruroides vittatus, and some pest management professionals request data specifically for this species. It can also be difficult to collect the number of scorpions of a single species required to conduct a study; while these two species' territories overlap, a collection trip can sometimes result in the capture of more of one species or the other depending on local geography. 

      EPA's Response: Regarding the request to add an option to test the Arizona bark scorpion (Centrurioides sculpturatus) as an alternative to Centruroides vittatus, the Arizona bark scorpion is a suitable alternative for testing to obtain scorpion labeling claims and will be added to the rule.

Comment 2-8: The commenter recommended allowing the tropical bed bug (Cimex hemipterus) as an alternative test species for making a general bed bug claim. Since most research on tropical bed bugs is performed outside the U.S., they also recommended allowing this data (and data for other pests requiring efficacy data) to be generated abroad.
 	
      EPA's Response: The Agency does not support testing of the tropical bed bug in lieu of the common bed bug for a general bed bug claim, as the common bed bug is more widely distributed and is relatively easy to acquire for testing. If an applicant would like to have a labeling claim specific to the tropical bed bug, data generated abroad may be acceptable on a case-by-case basis, depending on the type of test being performed. The Agency can be consulted prior to testing commencement. 

Comment 2-9: One commenter wrote in support of the description used for chiggers which belong to the larval (6-legged juvenile stage) of mites in the family Trombiculidae and emphasizes that only the blood feeding/pestiferous is the life stage relevant for testing.
	
      EPA's Response: EPA thanks the commenter for their support for the description used for chiggers.

Comment 2-10: One commenter noted that several species of the Loxosceles genus are medically relevant in the U.S., and these species have distinct and sometimes overlapping ranges but only one species was listed in the proposed rule. The commenter recommended that testing of a Loxosceles sp. be representative of "brown recluse spider" consistent with the recently proposed draft list of pests of significant public health importance, which lists the broad group of `recluse spiders, including: Brown recluse'.

      EPA's Response: The brown recluse, Loxosceles reclusa, is the most widely distributed and medically relevant recluse spider in the United States. Other Loxosceles sp. are found only in limited geographic areas within the United States. Therefore, EPA has determined that the brown recluse to be the appropriate representative species and the rule was not changed. 

Comment 2-11. One commenter recommended that Fannia be added as an additional "OR" species as opposed to the listed Calliphoridae. Fannia sp. would generally be more economically significant than blow flies. The commenter recommended that a "general flies" claim be defined in the proposed rule and that testing house fly, a tabanid sp., blow fly sp., and Fannia sp. would warrant this claim. The distinction between large and small biting flies, and filth flies is largely not a scientific grouping, as stable flies routinely and horn flies obligatorily develop in feces. The commenter recommended updating the testing guidelines in 810.3200 Livestock to resolve these issues in the proposed rule.

      EPA's Response: In response to comments relating to "filth flies," the smaller size of Fannia spp. may make them more susceptible to insecticides and could result in an overestimations of product efficacy. For claims against filth flies, the Agency chose to require test species from two of the three families comprising the filth fly group (i.e., Musicade, Calliphoridae, and Sacrophagidae). Replacing test species from the family Calliphoridae with Fannia spp. could result in assaying species from only one filth fly family. Further, Fannia spp. are one-half the size of Sarcophagidae and two-thirds to one-half the size of Calliphoridae. Within the family Muscidae, the genus Fannia are approximately two-thirds the size of the house fly. The smaller size of Fannia spp. compared to other filth flies could make them more susceptible to insecticides resulting in inaccurate overestimations of product efficacy claims towards filth fly. Consequently, the house fly, Musca domestica, was chosen as the representative species in the family Muscidae and Fannia spp. are not suitable alternatives to Calliphoridae. 
      The distinguishing characteristic of "filth flies" is their ability to carry pathogens and cause food-borne illnesses and not necessarily where the flies breed. Further, the "filth fly" term is a well-established category in the pest control industry.
       
      The rule includes a "Biting Flies" group and "large" and "small" biting fly sub-groups. Although large and small categories for flies can be subjective, the Agency has proposed to split the "Biting Flies" pest group further into "Large Biting Flies" and "Small Biting Flies (excluding Sand flies)" in response to the fact that periodically, the Agency receives requests for claims against large biting flies or claims against small biting flies. This provides that flexibility in the codified data requirements.
       
      A general fly label claim category will be added to the rule as requested, however Tabanids have been included and little house flies have been excluded. Therefore, a general flies label claim would require testing of the following five species: (1) house fly (Musca domestica), AND (2) (Flesh fly (Sarcophaga sp., Wohlfahrtia sp., and other genera of flesh flies) OR Blow fly (Phaenicia sp., Calliphora sp., and other genera of blow flies)), AND (3) Stable fly (Stomoxys calcitrans), AND (4) (Biting midge (punkie, granny nipper, no-see-um) (any Culicoides sp.) OR Black fly (any Simulium sp. or Prosimulium sp.) OR Black gnat (any Leptoconops sp.)), AND (5) (Black horse fly (Tabanus atratus) OR Deer fly (Chrysops sp.) OR Striped horse fly (Tabanus lineola)).

Comment 2-12: One commenter recommended that Ae. taeniorhynchus be considered as an additional option along with Ae. albopictus and Ae. aegypti. The commenter expressed a concern that Culex sp. is effectively only represented by one hybrid complex, Cx. pipiens x quinquefasciatus, and one primarily western/western marsh species, Cx. tarsalis. Both the FIFRA Scientific Advisory Panel (SAP) report and proposed rule "(q)uestioned the suitability of Culex pipiens and C. quinquefasciatus in repellent studies" but did not provide a basis for the statements nor does current repellent research support Cx. pipens x quinquefasciatus behave in a manner that disallows data collection. In light of the proposed rule, the only acceptable species for Culex sp. Efficacy would effectively leave Cx. tarsalis as the only Culex sp. to be allowable for repellent testing. This is unnecessarily limiting and not representative of the U.S. wide picture of West Nile virus vector contact, which is majorly composed of Cx. pipiens x quinquefasciatus and includes a suite of abundant secondary and bridge vectors, such as Cx. salinarius and Cx. nigripalpus. The commenter recommended that additional Culex sp. should be added to have suitable representation and accessibility of vectors, or that Cx. pipiens x quinquefasciatus not be omitted from repellent testing unless clear evidence can be presented that supports them as ineffective for product measurements.

      EPA's Response: For mosquitoes, Aedes aegypti and Ae. albopictus are primary vectors of numerous human pathogens and are adapted to preferentially feed on humans and are therefore the most appropriate representative species. Although Ae. taeniorhynchus is common and can vector some human pathogens, it is not a primary vector for human pathogens and was not added as an alternative species for testing. For testing Culex spp., the proposed rule lists Cx. pipiens or Cx. quinquefasciatus or Cx. tarsalis as representative species that can be used for testing, no rationale was provided to remove any of these species, nor were additional alternative species suggested. Therefore, EPA is finalizing these provisions as proposed.

Comment 2-13: One commenter stated that the inclusion of only two species of Triatoma is arbitrary, as numerous other species are relevant in different geographic regions. The commenter believed either one of the proposed species would be a suitable representative species for a claim for both "conenose and kissing bugs". Furthermore, other species may exist that should be considered as useful proxies for this pest group, as some are routinely maintained in colonies and medically important.

      EPA's Response: No scientific justification was provided to support bridging data between the conenose and kissing bugs, nor were alternative species suggested for testing. Therefore, EPA is finalizing these provisions as proposed.

Comment 2-14: The commenter noted that §158.1776 Ants (excluding carpenter ants) Test Species is not properly designated with "(b)" in the body of the rule and should be corrected.
      
      EPA's Response: Regarding the comment on §158.1776 Ants (excluding carpenter ants) that the test species is not properly designated with "(b)" in the body of the rule and should be corrected, the Agency will revise §158.1776 to change "Test species" to "(b) Test species".
      
Comment 2-15: One commenter requested that Anopheles hermsi be included as a test species for mosquitoes. The proposed "Pesticide Product Performance Data Requirements Rule" does not list Anopheles hermsi, as a test species, but does include the closely related sibling species, Anopheles freeborni. Anopheles hermsi and Anopheles freeborni are closely related sibling species that are morphologically indistinguishable from each other. Anopheles hermsi is a competent vector of malaria and is responsible for causing malaria outbreaks in the United States. Historically, Anopheles hermsi populations were incorrectly identified as Anopheles freeborni. In Southern California, Arizona, Colorado, and New Mexico, Anopheles hermsi is the predominant vector of malaria. 

      EPA's Response: After review of the information provided by the commenter, EPA has determined it is appropriate to add Anopheles hermsi to the rule as an additional option  testing the Anopheles genus.

Comment 2-16: Two commenters suggested that if a registrant wishes to claim product efficacy for a single species [of termite], testing on that species alone would be acceptable. While the commenters believed that is the case, they would like a clarification. 

Furthermore, a commenter stated that efficacy proven against Formosan subterranean termites should be adequate for the entire group of "subterranean termites." In general, only the subterranean termite is of concern for preservative treated wood. It is well accepted in the industry and by organizations granting product certifications, e.g., the American Wood Protection Association (AWPA) or the International Code Council, that data on the hardest to control termite, in this case Coptotermes formosanus, can be used to fulfill efficacy requirements for other North American subterranean termite species. Standardized preservative retentions are set at concentrations that will control Formosan termites and thus are also effective at controlling the less voracious species. If a preservative proponent wishes to differentiate retentions or application rates amongst termite species, only then should they be required to provide data on multiple termite species. 

In regard to 158.1784 for wood-destroying beetles, in an informal anecdotal discussion with university researchers, it appears that few, if any, labs are equipped to conduct efficacy studies on beetles such as lyctids and old house borers. An additional complication to testing is that damage is caused by beetle larvae and not the adult, making beetle testing inconsistent with testing for termite efficacy. 

The commenter also recommended renaming the header "Application Category" to "Label Claim" in the tables for wood destroying insects. 
	
      EPA's Response: As discussed in Unit VI of the preamble to the final rule, EPA proposed provisions for mosquitoes and ticks that specifically required group testing for an individual species claim because they are high stakes disease vectors and because consumers have difficulty differentiating between species. This has also been the Agency's general practice for termiticides because, due to the cryptic nature of subterranean termites, it is not possible for an applicator to know which species are present at the site of application. For subterranean termites, EPA did not propose regulatory text provisions analogous to those proposed for mosquitoes and ticks because EPA does not generally receive requests for claims against a single species of subterranean termite and because EPA would intend to continue its current practice even absent the regulatory change in those rare cases a request for such claims is submitted. 
      In response to the comment submitted, however, EPA realizes that clear text in the provisions for ticks and mosquitoes may create confusion as to the data need in this context. For this reason, in response to comment, EPA has added a provision to the final regulatory text specifying that for the structural protection and wood preservative claim categories, a claim against any specific genus of subterranean termite must be supported by data on that individual genus and all the required test genera for a subterranean termite claim must be tested and submitted. 
      Coptotermes formosanus is generally regarded as having the capacity to do greater damage in a shorter amount of time than other subterranean termites found in the United States. However, no data have been provided to support the claim that Coptotermes formosanus is a more robust species and that products and application concentrations that are efficacious against C. formosanus are universally efficacious against the other subterranean termite species in the United States. In fact, EPA's experience indicates that different concentrations of a product may be required for efficacy against Reticulitermes spp. than C. formosanus. EPA would need to see a wide range of data across chemistries to demonstrate that the LD50 is consistently higher for C. formosanus than Reticulitermes spp.
      
      The commenter proposed changing "Application Category" to "Label Claim" in the column headers of some tables for structural pests. "Labeling Claim" is already used as a column heading in other tables. Instead of "Label Claim," EPA has changed the column heading to "Claim Category" and reorganized the table to clearly identify non-structural wood-preservative claims and structural protection claims, as presented below:
      
Claim Category
Performance Standard
 Non-Structural Protection: Wood Preservative Treatment
100% prevention of damage to wood for >= 2 years
 Structural Protection, except Baits
95% prevention of damage to wood >= 5 years
 Structural Protection: Bait Treatment
95% prevention of damage to wood >= 3 years
       
      With regards to the comment on old house borers, please see the response to Comment 2-6. 
Comment 2-17: A commenter provided comments on Proposed 158.1704 Data acceptability.
The commenter noted that EPA states "that what constitutes a 95% standard is dependent on the type of study being performed. For example, for the standard U.S. Forest Service Concrete Slab field study, the 95% would be calculated such that any damage greater than nibbles to surface etching would be considered a failure; if a single plot had more than one instance of nibbles to surface etching in any of the standard five evaluation periods, this would also be a failure." In any trial with 10 replications, one replication showing feeding damage  -  even if not related to the treatment, e.g., atypical weather or post-treatment disturbance of the soil, would result in a failure.
Furthermore, the EPA uses the phrase "combined data" in this context. They asked for greater detail for this term. Does it mean the average or median value across replications?
The commenter asked that the EPA consider a 90% success rate for the U.S. Forest Service Concrete Slab tests be determined by the combined data for a product by rate in a given year. If in the following year, no damage is observed, how are these data interpreted?
 For a structural protection claim, what data are needed? Are successful laboratory `kills' trials (i.e., >90% mortality) plus USFS Ground Board and Concrete slab data (also demonstrating 90% success over 5 years) sufficient to support a claim of structural protection? Or is a conventional Experimental Use Permit research program involving inhabited residences still required (realizing that `true' replication - treated vs. untreated  -  is not possible). The use of `Proxy' structures  -  essentially 8 ft x 8 ft sheds  -  is acceptable in semi-field testing programs according to the EPA/APSCRO guidance, but these data are not acceptable to Florida (where a 350 sq ft structure is the minimum). Again, greater clarity on the performance standard to achieve a structural protection claim would be much appreciated.

For bait treatment, EPA is proposing a performance standard of 95% prevention of damage to wood for >=3 years." Again, what testing program approach is needed  -  semi-field or large-scale trials?

EPA is proposing that the termite standards for "direct applications to pests, surface applications, and spatial applications" will be changed to a performance standard of 90%, consistent with proposed 40 CFR 158.1704 performance standards for data acceptability. To that end, providing some guidance on [non-preservative] termiticidal wood treatments would be useful. 

      EPA's Response: The percentage damage to wood is the endpoint in Table 2, as measured across all replicates, not within each replicate. Neither structural protection nor wood protection claims have direct mortality endpoints. Direct mortality endpoints would be appropriate for products that are intended to kill termites at the time of application, but such claims alone are not structural protection claims and would not be subject to the standards for structural applications.
      
      EPA did not use the term "combined mortality" in the draft rule. However, EPA calculates the percent failure as the number of replicates that failed in any year out of the total number of replicates over five years. A replicate can fail only once in each trial and each replicate counts only once, even though it may be in the study over multiple years.
      
      EPA is not reducing the performance standard to 90%. Each replicate is included until that replicate fails or the required duration of efficacy is demonstrated. A replicate that fails in 1 year is a failed replicate for the duration of the trial. A replicate cannot "recover."
      
      The data required to support claims for structural protection are those which demonstrate 95% prevention of damage to wood for >=5 years. The commenter correctly identified the performance standard for bait treatments as 95% prevention of damage of wood for >=3 years. The studies that EPA has used to evaluate structural protection claims for termite baits have also not changed. Guidance is available in Product Performance Guideline 810.3600: Structural Treatments and Product Performance Guideline 810.3800: Methods for Efficacy Testing of Termite Baits to aid in the development of appropriate protocols for testing structural protectant product efficacy. Alternative methodologies may also be used, but consultation with the Agency prior to initiation of tests is recommended.
      
      Treatments to kill termites at the time of application are distinct from wood preservative treatments or structural treatments. Performance standards for claims that a product kills termites at the time of application without claims relating to providing any protection of wood or structural protection claims would be subject to the 90% performance standard specified in 40 CFR 158.1704. EPA has a longstanding practice of allowing label language to inform consumers that products labeled for termites and carpenter ants that do not provide structural protection are only for localized spot treatment to kill insects and are not intended to provide structural protection.

Comment 2-18: Commenter had concerns about the proposed performance requirements for pressure treated wood as they do not reflect the performance expectations considered acceptable in the AWPA) standards. For example, under AWPA standards termite damage representing up 3% of the cross sectional area of the sample would be still considered structurally sound if it did not progress. In Table 2 of paragraph C the Agency has proposed that an acceptable result (that would support termite label claims) is 100 % prevention of damage to wood for ~2 years for non-structural applications and 95% prevention of damage to wood for ~5 years for structural applications. They recognized the fact that for barrier or soil treatments such performance criteria may be appropriate but wood preservatives in general do not function as deterrents. As such, it is not uncommon to observe surface grazing or "nibbling" on test samples which by definition would fail the 100% or 95% protection requirements the agency is proposing. In fact, in pressure treated wood termite tests surface nibbling that does not progress to more significant attack is seen as a positive outcome because it establishes that the termites have actually challenged the test material and found it to be unpalatable. In addition, it would be helpful to get clarity from the agency on whether the 95% performance criteria is based on a calculated average and thus whether or not more significant attack present in some samples is acceptable.

      EPA's Response: Damage is distinct from light surface etching, which does not include any penetration into the wood. Light surface etching may occur without being considered a product failure for non-repellent products. The 95% performance standard is across replicates in the trial, but it is calculated based on whether a replicate passed or failed the test.

Comment 2-19: The commenter wrote, to strengthen the efficacy program and to provide flexibility and predictability, they request that the Agency to build flexibility into this rule for the required test species when making disease vector claims. For invertebrate disease vector claims, they appreciate the Agency's goal to ensure that all disease vector claims are supported by the appropriate product performance data. However, the commenter believed that public health will be best served by flexibility in the required test species. Some of the species that transmit specific vector-borne diseases are challenging to locate for testing purposes and the tests, along with the collection of the data, must be performed in a laboratory setting to mitigate release of the species into the environment. Ultimately, obtaining the specific species will lower the registrant's ability to rapidly respond to public health emergencies, since according to this proposed rule, the specific species which transmits the vector-borne disease must be tested for that disease vector claim. An alternative approach is to allow data performed on species of the same family or genus, enabling citing or bridging to existing data to satisfy a claim for a disease vector by a specific specie(s). Another option is to list which vector-borne diseases are already supported by the species required for a general pest claim (e.g., "mosquito" claim or "tick" claim). Fundamentally, this rule should allow for the bridging of data when a particular species that transmits a vector-borne disease is difficult to obtain for efficacy studies. This approach would offer the needed flexibility so registrants could still establish efficacy and register products necessary in the protection against vector-borne diseases.

      EPA's Response: When considering a disease vector claim, the Agency is requiring testing on the specific species that vectors the disease-causing pathogen. Therefore, EPA is finalizing the rule as proposed. The Agency acknowledges that flexibility may be needed in unique situations to address the difficulty of obtaining particular vectors for testing to support claims against a specific disease vector species. In these unique situations, the Agency may consider bridging rationales on a case-by-case basis. EPA notes that provisions in the regulations give the Agency the flexibility to modify the data requirements, where appropriate (see 40 CFR 158.1707). These provisions give EPA adequate latitude to respond to situations where species that transmit specific vector-borne diseases are not available for testing and suitable surrogates exist. 

Pest Group Comments: 
Comment 2-20: One commenter stated that the mite category could be clarified with examples: The fowl mites of poultry: Northern foul mite Ornithonyssus sylviarum, Tropical fowl mite Ornithonyssus bursa, Red poultry mite Dermanyssus gallinae and the chicken mite (Dermanyssus gallinae). The chiggers mites (Tromiculid mites) could also be added. (Abacus Consulting)

      EPA's Response: Applicants are required to have efficacy data on file for all labeled pests, including the poultry pests mentioned above. As discussed in Unit VII.C.3 of the preamble to the proposed rule, the Agency is requiring the submission of data on some veterinary pests listed above because, although they may be pests primarily of livestock, the pests have also been shown to transfer pathogens to humans (e.g., face fly) or occasionally bite humans (e.g., horn fly). However, veterinary pests that are not also of significant human health importance are not included in this rulemaking. Even though these efficacy data do not need to be submitted to EPA, the applicant is required to have efficacy data on file for all labeled pests, as per 40 CFR §158.400(e) note 1, and EPA may request submission of that data on a case-by-case basis. 

Unit 3: Performance Standards

Comment 3-1: One commenter expressed concern with the proposed section 158.1786 for termites stating that the proposed performance requirements are unreasonable and inconsistent with standardized performance evaluation methods and criteria for factory treated wood. Performance criteria of 100% prevention for 2 years for non-structural wood and 95% prevention of damage for 5 years for structural wood have been proposed. It is not uncommon to see surface nibbles on treated wood samples. Many termiticides are not "contact insecticides" but deterrents, and require the termite to nibble or ingest small amounts of wood. Therefore, these treatments could never pass the 100% protection requirement. The performance rating outlined in the AWPA E26 Ground Proximity Termite test is industry accepted. Ratings between 8-10 are considered acceptable under these standards. AWPA E26 is a severe, accelerated test method and higher levels of attack, i.e., ratings between 8 and 9, are not uncommon in well performing and currently standardized samples. Therefore, it is suggested that the performance ratings for preservative treated wood be consistent with standardized testing rating schemes and that target performance criteria be more aligned with established guidelines.

The lack of EPA's reference to specific test methods and expertise in wood preservation could lead to inconsistencies in severity of test methods and data used to support preservative registrations. For example, the AWPA E26 ground proximity test may result in more severe termite attack than a decking or lap-joint test, but all could be used to provide termite efficacy data. The reviewer will need to align the test method with the intended use(s) of the wood.
The performance criteria on the current proposal are vague, and there is no specific testing protocol/standard to evaluate the termite efficacy for factory treated wood. There are a few well-known AWPA standards that have long been used for evaluating termite efficacy of pressure treated wood; for example, AWPA E1 "Laboratory Methods for Evaluating the Termite Resistance of Wood Based Materials," AWPA E7 "Standard Field Test for Evaluation of Wood Preservatives to be Used in Ground Contact," and AWPA E26 "Standard Field Test for Evaluation of Wood Preservatives Intended for Interior Applications (UC1 and UC2): Ground Proximity Termite Test." 
      EPA's Response: First, EPA notes that the purpose of part 158 is to describe the minimum data and information EPA typically requires to be submitted. Part 158 "does not include study protocols, methodology, or standards for conducting or reporting test results" (40 CFR 158.1(b)(3)). EPA is not deviating for this longstanding structure for part 158 in this action. 
      
      While both EPA data requirements and industry wood treatment standards are intended to ensure that pesticide treated wood is resistant to insect damage, they differ in that EPA requires pesticide registrants to submit data in support of their registrations to facilitate a regulatory decision, while industry wood treatment standards are in place to ensure building elements meet minimum established standards. EPA pesticide product performance standards will ensure that pesticides are not labeled with unsupported marketing claims against wood destroying insects and will not supplant industry standards. For the reasons described in Unit VI of the preamble to the final rule, EPA is not incorporating by reference AWPA test methods. 
      
      The commenter correctly identified the performance standard for wood preservative treatments as 100% prevention of damage of wood for >=2 years. The studies that EPA has used to evaluate wood preservatives have not changed. Guidance is available in Product Performance Guideline 810.3600: Structural Treatments to aid in the development of appropriate protocols for testing structural protectant product efficacy. Alternative methodologies may also be used, but consultation with the Agency prior to initiation of tests is recommended.

Comment 3-2: In section 158.1786 table 2 beside the 95% claim being difficult to obtain, does this table imply wood consumption would be the only measurement for termite trial
performance standard. There are several types of termite trials such as direct mortality
of individuals, structural protection field trial that typically use other performance
standards. The commenter recommended EPA describe in more detail the scientific basis for this product performance requirement and consider whether other approaches can more readily achieve the same outcome. 

      EPA's Response: The percentage damage to wood is the endpoint in Table 2, as measured across all replicates, not within each replicate. Structural protection claims do not have direct mortality endpoints. Direct mortality endpoints would be appropriate for products that are intended to kill termites at the time of application, but do not provide structural protection.

Comment 3-3: One commenter noted that the 2013 SAP believed that the 95 percent performance standard for products other than skin-applied insect repellents "would create a burden for unattainable results and would be cost prohibitive in most situations, particularly for large scale field trials, or in general, any field trial using a 100% standard expectation" and concluded that "a minimum 90% performance under controlled laboratory conditions would be adequate." EPA agreed with the SAP's conclusion that an across-the-board 95 percent standard was impractical and is "proposing performance standards of 90% or greater instead of 95%," but it kept 95 and 100 percent performance standards for certain pests, including carpenter ants, termites, wood-destroying beetles, human mites and lice, wood-destroying pests, and non-structural wood preservative treatments.

While they appreciated EPA's decision to adopt a 90 percent performance standard for some pests named in the proposed requirements, they recommended the Agency adopt this same standard for all pests, including those for which it proposes using a higher standard. The reasons for not adopting a 95 or 100 percent standard are valid regardless of the pest being tested; if biological variability, scientific probabilities, and testing artifacts can affect the outcome of a study, it is still difficult or impossible to rely on a performance standard greater than 90 percent. Using a 95 or 100 percent standard may also limit the development of new chemistries, including chemistries that pose lower risk to human health or the environment, that cannot perform to a such a standard during efficacy tests. In addition, control mortality could affect a product's ability to meet a 100 percent standard because, to meet statistical analysis requirements, all treatment replicates would need to reach 100 percent efficacy and all control replicates would need to be zero percent mortality in order to achieve 100 percent overall efficacy within the study. Adopting a 90 percent performance standard across the board for all pests would resolve these problems while still ensuring that products adequately demonstrate efficacy against pests. 

      EPA's Response: EPA disagrees that use of a 95 or 100 percent standard in the limited instances where EPA is requiring it would limit the development of new chemistries including those that pose lower risk to human health or the environment. Historically this has been an attainable performance standard. The data are required to demonstrate that the products will perform as intended when applied according to the directions for use on the label. The studies are conducted under highly controlled field and/or laboratory conditions. While lowering the standard for some pests is acceptable because trials can be established with adequate minimum pest pressure, wood destroying insects are cryptic or the treatments are tested under field conditions that may have variable pest pressure. Additionally, for products that are intended to provide structural protection of homes and other occupied structures or prevention of damage to wood that is a critical element of a structure (e.g., bridges), reducing the performance level could result in dangerous or financially ruinous damage. In the case of lice, complete eradication of the infestation is necessary to prevent reinfestation of the host by remaining insects.
      
      With respect to the comment regarding excessive control mortality, in order to make the requisite findings under FIFRA, EPA requires a study that is conducted in a scientifically sound manner, and if there is excessive control mortality they may not be able to demonstrate/have confidence in the efficacy of their product.
      
Comment 3-4: When laboratory studies are conducted on animals, the efficacy requirement must take into account the number of animals used to demonstrate the control level. For example, demonstrating 100% efficacy for the dog follicle mite could require a number of replicates that would not increase understanding of product efficacy, as indicated by the 2013 FIFRA SAP on data needs for products claiming efficacy against invertebrate pests.
      EPA's Response: The 100% performance standard for the dog follicle mite is to ensure a product works and should not require repeat treatment. Because dogs that show symptoms have a weakened immune system and would continue to show symptoms if the mites are not eliminated from the animal, the 100% standard is appropriate for efficacy against this pest. EPA is committed to minimizing the number of animals required for testing purposes, however, discussions regarding the number of animals used for testing are outside the scope of this rule.
Comment 3-5: The commenter recommended revision of the 100 percent performance standard for termites (application category of non-structural wood treatment for the prevention of damage to wood for >= 2 years), human itch or scabies mite, dog follicle mite, lice, and Vespula spp. (yellowjacket). In practical terms, the 100 percent performance standard is unattainable because if one organism survives in the treated sample, the data is deemed unacceptable. For any biological system, there are always outliers and significant variability, and there is the high probability that even effective products may not achieve the 100 percent standard, no matter how efficacious the product. Therefore, they recommended revision of the 100 percent performance standard to a performance standard of no greater than 95 percent, which would establish a rigorous standard for product efficacy.
      EPA's Response: This is an attainable performance standard that registrants have been able to meet for years. Comments provided no support for a claim that such a standard is or has not been attainable for the pest products listed. The data are required to demonstrate that the products will perform as intended when applied according to the directions for use on the label. The studies are conducted under highly controlled field and/or laboratory conditions.
      
Unit 4: Definitions

Comment 4-1: One commenter stated that having a common understanding is essential for registrants to satisfy EPA data requirements. 

Performance Standards:

 Kills vs. Controls - While it is not explicitly addressed in this rule, additional clarity on obtaining a `control' claim vs. `kills-only' claim (although this guidance may be better addressed in the specific Series 810 Guidelines, we thought it appropriate to raise the issue here also) would be greatly appreciated. 
   
 Use of Abbott's correction  -  if mortality in the untreated control is kept <10%, is the use of Abbott's necessary? If mortality in the untreated control exceeds 10%, should the trial be terminated and, if so, should data from the terminated trial be submitted to the EPA along with the successful trials (marked as `data not used')? 

 Additional Pest claims  -  if the target pests are controlled (>90% mortality), can additional pests be included on the label if mortality does not reach 90%, but is greater than some minimum threshold, e.g., 60%, as a `suppression' claim? Could it be evaluated as Supplemental (corroborating) data? 

 Speed of kill for fast-acting (contact) vs. slow-acting (ingested toxins)  -  registrants requested greater flexibility in designing performance trials for slower-acting active ingredients. Time periods for assessing the insect response need to be adjusted based on the mode of action and the resulting speed of kill of the product.

 Test subjects (mixed-sex and mixed-age populations, including resistant strains) - should test species populations always contain both sexes and both adults and juveniles to support a `control' claim? What standard would need to be met to support a "controls" or "suppresses" claim for resistant strains? 

 Retreatment intervals for both indoor and outdoor uses  -  guidance on how to determine retreatment intervals for indoor and outdoor residual activity, particularly for perishable food-based invertebrate (or vertebrate) baits, would be appreciated.

 The need for laboratory studies, semi-field/cage trials, and large-scale field studies  -  realizing that the needs for the various trial types is often species-specific and claim-dependent, some additional guidance would be helpful (particularly for flies, cockroaches and termites). 
      
      EPA's Response: Comments a, b, d, e, f, and g are related to guidelines/guidance and are outside the scope of this action.
      
      With respect to comment c, while EPA would consider all data submitted, for the pests covered by the rule, EPA generally does not approve "suppression" claims and therefore EPA did not propose performance standards for such a claim. As discussed in Unit VI of the preamble to the final rule the provisions at 40 CFR 158.1707 and 40 CFR 158.45 allow entities to request a modification of data requirements or a waiver from those requirements that they believe are not appropriate for the unique circumstances of their products.
      
      If product performance data demonstrate adequate control of the representative test species to support claims against the group, but the registrant has information that the label claims against other species in the pest group fail to meet the applicable performance standard, those data need to be reported under FIFRA 6(a)(2) reporting requirements.
      
      Registrants are still required to generate, and make available to the Agency on request, data to support all pest for which claims are made on the label. Pests not included in the product performance rule, thereby lacking identified performance standards, are included in this requirement, if they are claimed on the label. The Agency is not establishing performance standards for the invertebrate pests not included in the rule; however, claims against those pests not included in this rule should be supported by data demonstrating efficacy that is consistent with generally acceptable levels of efficacy against the pest to the extent that would be required to support a favorable FIFRA determination that the product when applied according to the label "will perform its intended function without unreasonable adverse effects on the environment."

Comment 4-2: With respect to proposed section 158.1786, wood can be treated in two separate scenarios. First, wood can be pressure treated or topically treated with a registered product in a factory ("factory lack treated") and the treated wood is then used in construction. This includes commodities such as dimensional lumber, laminated beams, glueline treated engineered wood and others. Second, wood can be treated in situ after the wood is in place. While not clear, it can be interpreted that pesticide products used for factory treated wood are subject to 158.1786, just as products used to treat wood on site. The commenter believed section 158.1786 does not specifically address factory treated wood products. Because the methods are so different, the proposed language under Table 2 can be confusing. To clarify, the commenter suggested that in Table 2 to Paragraph (c) in sections 158.1782, 158.1784 and 158.1786, the column heading "Application Category" be changed to "Label Claim" as the criteria in each table are really related to claims. The commenter also suggested "Non-structural: Wood Preservative Treatment" be deleted and replaced with "No Structural Protection" and the definition of "No Structural Protection" be added to 158.1701. The terms "Structural" and "non-structural" are used in other facets of construction and should not be used as it will cause confusion. To look at treated wood examples, then, a topically applied insecticide during or after construction, claiming total structural protection, would require 95% prevention of damage to wood five years or longer. A topical application product which does not provide total structural protection and does not claim structural protection would require 100% efficacy for at least two years. While not clear, it can be interpreted that registrations of products used for factory treated wood would fall under the two-year requirement category unless the claim is for total structural protection. 
 
      EPA's Response: Treated wood products can fall under the data requirements for structural protection or protection of treated wood only (i.e., non-structural) depending on the claims being made. The products are subject to the rule regardless of the classification of the active ingredient as a conventional, biopesticide, or antimicrobial pesticide. Industry standards, such as the AWPA, may also apply to products intended for use in the construction industry, but are neither required to be met nor sufficient to demonstrate efficacy for EPA registration. 
      EPA is adding a definition to the rule to help clarify the intended meaning of the requirements as applied to the distinct use patterns.
      Structural protection definition: For the purposes of product performance data against invertebrate pests, structural protection is defined as per 158.1703 as "the prevention of termite or other wood-destroying pest activity in an entire structure as the result of an application of a pesticide product." To add clarity, EPA is adding a definition for "Wood protectants and other non-structural protection" which means the prevention of termite or other wood-destroying pest activity only to the treated wood (or other treated material), whereas structural protectants, however applied, claim to prevent damage to the structure. See EPA's Response to Comment 2-16.
Unit 5: Invasive Species

Comment 5-1: One commenter wrote that the other consideration in invertebrate pest control is the need to allow for efficient responses to new and emerging pests such as the Tropilaelaps mite of honeybees which has not yet arrived in North America.

      EPA's Response: As discussed in the responses to Comment 2-2, this rule generally does not cover agricultural pests. However, EPA may, on a case-by-case basis require submission of efficacy data, including in situations where an invasive species could cause significant economic or ecological damage and the efficacy of products used against that species is not readily apparent at the time of application. 
      
      EPA agrees with the commenter that pesticide products are an important tool for managing the spread of an invertebrate invasive species and the related health concerns or significant economic impacts. This rule will not inhibit responses to emerging pests. EPA believes treating invasive species quickly and appropriately is critical. Existing efficacious products can be used against invasive species in accordance with FIFRA section 18 and 24(c), or, in cases where the proposed use pattern and use site is authorized by the label, pursuant to FIFRA section 2(ee).

Comment 5- 2: One commenter stated their concern that the invasive species portion of the proposed rule is not adequately explained and the process for inclusion is not transparent. They recommended that EPA develop a process for inclusion of invasive species and elicit
stakeholder feedback. 

      EPA's Response: EPA believes that treating invasive species quickly and appropriately is critical and does not intend to preclude use of a pesticide product pursuant to FIFRA 2(ee) to treat an invasive species. EPA believes that pesticide products are an important tool for managing the spread of an invertebrate invasive species and the related public health concerns or significant economic impacts. The availability of pesticide products with proven performance against an invasive species is important to slowing the spread of the invasive species.
      Due to the sudden appearance and often rapid spread of invasive species, except for the pests noted, EPA does not presently intend to list the specific invasive species for which product performance data might be deemed necessary to support registration of the pesticide product. Instead, the submission of product performance data to support claims for effectiveness against invasive invertebrate pests will be considered on a case-by-case basis. Given the expectation of infrequent submission of such an application, a "case-by-case" approach is the most suitable. EPA recommends that applicants consult with the Agency when first considering a submission to place an invasive species on the label of a pesticide product. As part of the consultation, EPA would be able to provide information on protocol development and selection of test species.
      As discussed in Unit VI of the preamble to the final rule, a pest's status as an invasive exotic species is just one factor that may warrant submission of product performance data so that EPA can make the requisite statutory findings under FIFRA. EPA does not anticipate requiring data for invasive exotic species solely because they are invasive exotic species. EPA anticipates requiring submission of data for invasive exotic species when they are likely to have significant ecological or economic impacts, or when EPA determines they are pests of significant health importance. As with the emerald ash borer and Asian longhorned beetle, whether the efficacy of the products can be determined at the time of application is one factor EPA takes into consideration when determining if submission of efficacy data is necessary to make the requisite findings under FIFRA.

Comment 5-3: Another commenter stated "Similarly for invasive species claims that require the submission of product performance data to the Agency, we request a transparent process for the addition of invasive species, beyond the emerald ash borer and the Asian longhorned beetle, which are currently the only invasive invertebrate species proposed. More specifically, we request clarity on the entity that can add invasive species that would require the submission of product performance data to the Agency to support efficacy claims. We believe this assessment must include registrants if third parties are involved." 

      EPA's Response: See EPA's Response to Comment 5-2. While USDA maintains a list of invasive species profiles, EPA is the entity that would require data to support efficacy claims against an invasive species on a product label. A pest's status as an invasive exotic species would not automatically trigger a requirement to submit efficacy data, but it is one factor that EPA would consider when determining whether submission of such data is necessary to evaluate the pesticide product. 
      
Unit 6: Miscellaneous

Comment 6-1: One commenter wrote that good laboratory practice (GLP; 40 CFR 160) should not be a requirement for efficacy studies conducted in support of products claiming efficacy on the invertebrate pests. The commenter stated that most University and Federal government (e.g., USDA) laboratories, with the permitting required to rear and test quarantine pests, and/or a recognized expertise in conducting efficacy trials on unique pesticides and/or the invertebrate pests addressed in this rule, are not GLP certified. A common opinion of lead researchers in these types of laboratories is that GLP research significantly increases the research cost without improving research quality and has unnecessary paperwork and procedural requirements that can limit research creativity and productivity. It is the experience of the commenter that when a laboratory is capable of conducting both GLP and non-GLP research, the quoted cost for a GLP protocol is at least 3-fold more than the identical non-GLP protocol due to increased paperwork required for GLP. Laboratories that are GLP-certified are often private, commercial laboratories that may not have the expertise or permitting required to handle the types of invertebrate pests addressed in this rule.

The commenter also wrote that there are alternative criteria to GLP for verifying research quality that should be considered, such as: the efficacy study on the pesticide for the required pest has been published in a peer-reviewed science journal; the researcher conducting the efficacy study has previously published efficacy research on the target pest or on the unique pesticide in peer-reviewed science journals; and the efficacy research was conducted using a protocol reviewed and approved by the EPA.

      EPA's Response: The provisions at 40 CFR part 160 describe good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits for pesticide products regulated by the EPA, and to assure the quality and integrity of data submitted pursuant to sections 3, 4, 5, 8, 18 and 24(c) of FIFRA, as amended, and section 408 or 409 of the FFDCA. The provisions at 40 CFR 160.12 require studies submitted in support of an application for registration to be accompanied by a statement of compliance or noncompliance with 40 CFR part 160. Where a study has not been conducted in accordance with good laboratory practices, the registrant is required to submit an explanation of the deviations. This does not preclude a study from being considered in support of an application for registration. 
      
      EPA did not propose changes to the applicability of 40 CFR part 160 and is not finalizing any such changes. This rule neither expands nor contracts that applicability of 40 CFR part 160.

Comment 6-2: One commenter asked that EPA clarify that the requirements of the rule as they pertain to existing pesticides. The commenter stated that there are many situations in which the historical efficacy data for an existing EPA approved pesticide has been sufficient to reliably substantiate the claims of the pesticide's effectiveness, even when the data do not meet the testing methods and documentation proposed by this rule. Applying the provisions of the proposed rule retroactively to these existing pesticides would be unnecessary, creating a financial burden for the registrant and additional cost to the end-user without added benefit. 

	The commenter states that the rule could clarify exemptions for existing pesticides such as: 
 The laboratory and/or researcher conducting the efficacy research had a recognized expertise in the target pest and/or the unique pesticide evaluated.
 Efficacy research was conducted and documented using methods in experimental design, and analysis and interpretation of the results that were acceptable at the time the research was conducted.
 Current pesticide quarantine treatment schedules, particularly for fumigants, should be exempt.

      EPA's Response: EPA is not adopting the specific exemptions suggested by the commenter. While EPA has the authority to issue a data call-in for a particular product, because the provisions of this rule reflect the longstanding data-needs of the Agency, EPA expects that the Agency already has the necessary data for most of existing pesticide products covered by this rule. EPA notes that as part of the economic analysis conducted in support of this rulemaking, EPA looked at a sampling of more than 30 data package submissions and did not find any that did not meet the requirements as encompassed by the rule, although EPA did find some that had extra data beyond what this rule requires. 
      
      With respect to the quarantine fumigants mentioned by the commenter, these products generally make no specific public health claims, and are typically targeting nuisance pests on food, so they may not be subject to the data submission requirements of this rule. 

Comment 6-3: One commenter wrote that while this rule is generally a codification of current practices, there are some efficacy studies currently underway; therefore, they requested a compliance date of at least one year from the effective date of this rule being finalized. 

      EPA's Response: The rule mainly codifies the Agency's current policies and, in some cases, allows for even more flexibility in testing (e.g., by the addition of more species options for testing in response to public comments). Without more detail from the commenter, it is difficult to determine what issues might be presented if applying the final rule to these studies. Furthermore, section 158.1707 of the rule allows the Agency to consider modification requests for the submission of alternative data on a limited, case-by-case basis. EPA must deem the modification acceptable and ultimately the data appropriate and sufficient to make the determinations required by the applicable statutory standards. Therefore, the Agency does not believe a compliance date of at least one year from the effective date is appropriate.

Comment 6-4: The commenter stated that "There are multiple ways in which the text of the Proposed Rule indicates that it does not apply to wood preservatives for pressure treatment or pressure-treated wood making claims against termites.... the economic impact analysis supporting the Proposed Rule contains no assessment of the substantial additional costs that would be imposed on registrants of pressure wood treatment products."
The commenter disagreed with EPA's assertion that "[f]or the most part, the data requirements that EPA is proposing for codification are consistent with EPA's current practices," as it pertains to wood preservatives and pressure-treated wood products, which, as explained above, currently are addressed through a system of consensus standards. In the event that EPA insists on changing current practices and imposing a new approach for efficacy requirements that applies to wood preservatives and treated wood products, the Agency should initiate a proceeding to do so. This will ensure that EPA obtains complete information on current tests and standards. It also will allow EPA to assess the economic impact of any new requirements it plans to impose. In the event EPA decides to impose additional regulation in this area the commenter urges EPA to consider incorporating existing tests and standards.

The commenter expressed concern that imposition of any new method will have economic and competitive impacts on a market that now functions well. EPA should seriously consider these impacts. It is particularly important that EPA make any new requirement applicable to all pressure treatment wood preservatives making covered claims at the same time. Requiring new tests going forward on a rolling basis for existing registrations could have dramatic competitive consequences, advantaging some products and disadvantaging others. Any future proposal must be applied equally to all wood preservatives at the same time in order to prevent any competitive disadvantages in the industry. Additionally, any future proposal must clearly seek comments for implementation so that EPA can understand the burdens and impacts it will be imposing on industry. 

      EPA's Response: The performance standards in the rule do apply to wood treatments (i.e., wood preservatives, including insecticidal pressure treatments). OPP has required data for wood destroying insects in support of pesticide products making claims against those pests regardless of the classification of the pesticide as a conventional or antimicrobial pesticide for more than a decade. Because there are no changes to the standards or the data requirements for claims made in support of these products, there are no new impacts specifically to the registrants of wood treatment products. 

Comment 6-5: A commenter wrote in support of the EPA's proposal to codify product performance data requirements to support registration of pesticidal products claiming efficacy and proposes escalating the voluntary nature of the MOU to a requirement to further strengthen the relationship between the EPA, TLRC, and the TSC. "Interaction between our agencies represents a critically important phase during the termiticide registration process for both conventional and unconventional (emerging technology) termiticides." 

      EPA's Response: EPA agrees that the MOU with the Association of Structural Pest Control Regulatory Officials (ASPCRO) has served an important role. EPA and States working with registrants and testing laboratories ahead of conducting complicated, multiyear studies has proven to be valuable for ensuring that data generated and submitted with an application are adequate in their design and execution and thus ultimately conform to the claims made for the pesticide. As a result, EPA strongly encourages applicants to continue to take advantage of the opportunity to consult with TLRC and/or TSC.
      
      To the extent the commenter is suggesting that EPA should regulatorily mandate this consultation, EPA did not propose such a provision and has not conducted an analysis sufficient to support such a mandate. Accordingly, this comment is outside the scope of this rulemaking. 

Comment 6-6: One commenter said that there is an opportunity in this rulemaking for the Agency to establish transparent performance standards on the use of "control" versus "kill" labeling claims. All labeling claims should be based on clear definitions; hence, we urge the Agency to establish a transparent regulatory framework for the claims of "control" versus "kill," so when used, are consistently applied.

      EPA's Response: EPA has determined that these terms are better defined in guidance documents, where they may be used in a situation-specific context.

Comment 6-7: One commenter stated "While registrants appreciate the ability to decrease the amount of testing using representative species, certain species may be important for specific markets so a claim such as "controls cockroaches, including Oriental and Brown-banded" would be of interest. To support this claim, efficacy data that demonstrates >90% mortality of American, German, Oriental and Brown-banded would be submitted. This allows flexibility in a registrant's testing program."
 
      EPA's Response: The Agency agrees with the commenter's interpretation.

Comment 6-8: The commenter wrote "At the bottom of the third paragraph of the Lyme disease discussion on page 15369 the preamble reports "Many of these symptoms will resolve, even without treatment." It is well documented that many of these symptoms do not resolve as is indicated." Tick-Borne Diseases are life altering and can cause death. Refer to https://lymediseaseassociation.org/, President Pat Smith, for more details on potential risks from a tick bite. It is also well documented that Lyme Disease can cause congestive heart failure which can lead to heart transplantation. See references below..."

      EPA's Response: EPA agrees with the commenter. The text cited by the commenter is not included in the preamble to the Final Rule.

Comment 6-9: The commenter stated that "There are multiple ways in which the text of the Proposed Rule indicates that it does not apply to wood preservatives for pressure treatment or pressure-treated wood making claims against termites.... Third, the proposal is issued by OPP's Registration Division, while wood preservatives for pressure treatment are registered by the Antimicrobial Division, which is not referred to at all in this proposal." The commenter requested that EPA clarify that the Proposed Rule is not intended for, and should not apply to, products for pressure treatment of wood, based on the text and intent of EPA's proposal. Additionally, the efficacy of treated wood is already subject to validation through consensus standards. 

      EPA's Response: See EPA's Response to Comment 6-4.

Comment 6-10: The commenter wrote that proposed Section 158.1700 states "The Agency may require, as specified herein and on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment." If the requirement for data is left to the reviewer, there is no guarantee of a consistent, across the board requirement and thus the requirements become arbitrary and at the whim of individual reviewer, defeating the consistency intent of the proposed rule. The parameters that will be used to determine when data are necessary for submission need to be clearly defined and transparent to industry. While these proposed regulations will somewhat negate 810.3600, nothing is proposed to replace a set protocol or procedure, especially for factory treated wood. As a result, further review and consultation with industry are warranted. 

      EPA's Response: The provision being established in 40 CFR§158.1700 allowing the Agency to require data for invertebrate product performance on a case-by-case basis is no different than the existing provision in 40 CFR§158.400(d) footnote 1. The rule, however, clearly establishes performance criteria for the species found in the U.S. that the Agency has generally required to support label claims. Furthermore, the rule does outline the pests for which the Agency is likely to require product performance data  -  those that pose a risk to human or companion animal health, cause structural damage, or could result in substantive ecological damage. Due to the nature of emerging pests, it is not possible to identify all potential taxa for which the submission of data may be required, but the rule is an effort to provide clarity with respect to both the species for which data are required and the performance level that must be achieved to support claims against specific pests or groups of pests.
      
      The Agency maintains a distinction between the data submission requirements and performance standards in the rule and the protocols used to demonstrate adequate product performance in the test guidelines. Guidelines are provided for the most common studies submitted. The guidelines provide information in addition to scientifically sound study design that is intended to aid registrants in designing studies that the Agency will find satisfactory for the purposes of supporting the registrants' label claims. Guidelines are not required protocols however, and registrants have the latitude to conduct scientifically sound non-guideline studies to demonstrate the performance of their products. The Agency will consider the test protocol and study results in light of scientific reliability in support of the desired label claims. Registrants are encouraged to consult with the Agency when registering novel technologies or considering nonguideline studies that may demand a unique protocol. Protocols may also be submitted to the Agency for review under the Pesticide Registration Improvement Act (PRIA). The Agency uses an internal peer review process and consultation between reviewers to maintain consistency and minimize the possibility of individual reviewers' "whims" impacts on regulatory decisions. EPA reviewers are typically in close communication with registrants, and registrants have the opportunity to voice any concerns that they may have about the review of their submission. 

Comment 6-11: 
The commenter noted that EPA states that "the applicant may submit a protocol of his own devising for the Agency to review. EPA notes that there is a PRIA fee category for submitting a protocol for EPA to review". The commenter stated that this is a concern of registrants. The commenter has found that a confirmation of data acceptability, or at least provisional approval of the means to generate that data, is needed prior to data submission (and, optimally, even before trial protocol development); approval could be in the form of an informal discussion with the EPA Product Manager or a formal protocol review (but a lower fee and a shorter PRIA review timeline  -  possibly, a separate PRIA category for Series 810 protocol reviews - would encourage a formal protocol review).

      EPA's Response: Thank you for the comment, however it is outside the scope of this action.

Comment 6-12: A commenter asked EPA to consider § 158.1707 Data requirement modifications. They wrote that EPA states that "data requirements (including the performance standards associated with the data requirements) specified in this subpart as applicable to a category of products will not always be appropriate for every product in that category. Data requirements may, on a case-by-case basis, be adjusted by EPA in response to requests for novel technologies or products that have unusual physical, chemical, or biological 
properties or atypical use patterns which would make a particular data requirement, or data performance standard, inappropriate. Requests for such data requirement modifications must be submitted in the same manner as waiver requests submitted under 40 CFR 158.45. If the waiver request is denied, will the EPA consider a conditional registration dependent on the registrant satisfying the data requirement within 12-18 months?" 

      EPA's Response: Under most circumstances, a conditional registration would not be appropriate if a request under 40 CFR 158.1707 is denied. In the absence of the required data that is the topic of this type of request, the Agency would not typically be able to make the determinations required by the applicable statutory standards. EPA notes that the data requirements codified by this rule are consistent with longstanding Agency practice and informed by years of experience regarding what data is sufficient to permit EPA to evaluate the potential of the product to cause unreasonable adverse effects to man or the environment. 

Procedural Requirements

Comment 6-13: A commenter noted that §158.1700(b) is clear with respect to new registrations in that "(t)his product performance data must be submitted with any application for registration or amended registration. For the pest-specific claims listed in this subpart, data must be for the species specified to support the claim." However, amendments or supplemental
registrations dependent upon a base registration would benefit from additional clarity.
For example, if a company were to submit an amendment to a currently registered product (e.g., to add marketing claims, or new applicators), would EPA re-review the data on file to ensure consistency with the new standard and/or require submission of new data to support new claims? It is also not clear how this will impact supplemental distributed product. Additionally, there is a lack of clarity of how this will apply to `me-too' registrations, were a registrant to submit a data matrix with the "me-to", and copy the basics claims, would EPA re-review the efficacy data to determine consistency with the new standard? They requested additional clarity be incorporated to address these procedural requirements.

      EPA's Response: These data requirements are mainly codifying current Agency practices. If the Agency determines there is an absence of acceptable data for a particular requirement as it continues to manage pesticide registrations, the affected registrants will be informed of the deficiency, but as a general rule, the Agency does not expect the need to reconsider the data used to support the existing registration when reviewing an application for an amendment that does not change the use instructions unless there is a need to confirm that the proposed claim is supported by the historical data. Requirements for supplemental distribution of a registered product will not be changed by the publication of this rule and can be found in Chapter 9 of the Pesticide Registration Manual (https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-9-supplemental-distribution-registered). Products are subject to the same data requirements regardless of whether they are submitting newly generated data or citing existing data. Me-too registrations are typically be supported by either method. 

Comment 6-14: The commenter stated that the proposed rule does not include timeframes for implementation which appears to indicate that the requirements will become effective with final adoption of the rule. Given that it often takes over six months to a year to rear and obtain several of the test species, along with the time necessary to perform the testing on additional test species, requests that inclusion of a phase-in period for both representative species and efficacy data. They also pointed out that there may not currently sufficient lab capacity to complete the additional testing due to continuing impacts associated with COVID-19 and urged EPA to consider additional flexibility as these requirements are implemented. 

      EPA's Response: The rule codifies the Agency's current policies and in some cases allows for even more flexibility in testing (e.g., by the addition of more species options for testing in response to public comments). The Agency acknowledges that COVID-19 may have affected lab capacity to complete efficacy testing. However, EPA notes that section 158.1707 of the rule allows the Agency to consider modification requests for the submission of alternative data on a limited, case-by-case basis. EPA must be able to find that the modification request is acceptable and ultimately that the data are appropriate and sufficient to make the determinations required by the applicable statutory standards. Like many Agency rules, the effective date for the final regulation will be 60 days after publication of the final rule.

Unit 7. Representative Pest Species

Comment 7-1: One commenter stated that the listing of representative species is very helpful to registrants and is much appreciated. The commenter suggested that this list be revisited and updated on a defined schedule, e.g., annually or biannually. The commenter agrees with the current list with the following exceptions: 

 Termites  -  having a general termite claim may not be appropriate as the application methods to control subterranean, drywood, dampwood, and arboreal termites are quite different, and this type of claim likely will be problematic for state registration. Also, the absence of desert subterranean termite will pose a challenge for registrations in the western U.S. (and the issue of having insufficient data for the western states is exacerbated by the loss of the AZ site for USFS Termiticide Trials). 

For a claim against subterranean termites, including formosan subterranean termites, EPA is proposing testing on Coptotermes formosanus; and one of the following Reticulitermes species: Reticulitermes flavipes, or Reticulitermes hesperus, or Reticulitermes virginicus"; the commenter agreed with these representatives, but also recommended the requirement for Heterotermes spp. 

Claims for dampwood or arboreal termites should be treated separately.

 Flies  -  The commenter appreciated the greater clarity regarding the sub-groups, which will help in the design of efficacy trials. 

 Fire Ants  -  the recently published guidance for this pest has posed many significant challenges in developing field protocols to test both broadcast and mound treatments; the commenter, in discussion with other registrants, requests whether this Series 810 guidance could be reevaluated. Plot size and separation of the plots, i.e., 56' between plots and areas with a history of no insecticide treatments, will make finding field sites for these trials difficult. 

 Cockroaches  -  see previous comments regarding developing label claims and test subjects (i.e., mixed age and sex populations and resistant strains). 

 Carpenter Ants (and other wood-destroying insects)  -  additional guidance is needed to understand the performance standards for both baits and sprayable treatments with regard to 3-year residual activity. 

 Ants  -  The commenter requested greater detail on colony-control claims: does the 90% control level also apply for field trials? Within what time period should control be achieved? And no reappearance of activity within `X' days? 

 Stinging pests  -  The species required for Claims against Bees, Wasps, Yellowjackets and Hornets lists the Bald-faced hornet, which is not a common species and likely will be hard to find for trialing. 

 Bed bugs  -  Can the Series 810 guidance be revisited? Obtaining field-collected populations (and assuming pesticide exposure and some level of resistance) are difficult to get to reproduce and require additional time and generations to build up a colony to sizes necessary to do the trialing. 

      EPA's Response: Comments c, d, and h are related to guidance, label claims, and test guidelines that are outside the scope of this action.
      
      In response to part "a" of the comment, a general claim would be appropriate if they have the data from each of the representative species required to support the general termite claim. EPA finds these species adequate for national registration, if states/territories do not want to register products they could choose to require additional data (e.g., Heterotermes) or not register the product in their state.
      
      Claims against dampwood and arboreal termites may be supported individually or as part of the general termite claim, therefore, no change is needed to the rule.

      With respect to part "e" of the comment, EPA has clarified the performance standards for carpenter ants as follows:
      
Claim Category
Performance Standard
 Non-Structural Protection: Wood Preservative Treatment
100% prevention of damage to wood for >= 2 years
 Structural Protection, except Baits
95% prevention of damage to wood >= 5 years
 Structural Protection: Bait Treatment
95% prevention of damage to wood >= 3 years
      
      In the part of the comment on ants, it was asked if 90% control level also apply for field trials. The same performance standard applies to both laboratory and field trials. The length of time required for control to be achieved and before reappearance of pest activity are both dependent on the claims on the product. 
      
      The commenter expressed concerns that the bald faced hornet is not a common species and it will be difficult to find the species for efficacy trials. The Agency has received data for these pests in the past and does not anticipate this to be an issue because the species is widely distributed. This was also not identified as a concern when representative species were evaluated by the SAP. See EPA's Response to Comment 2-16.
 
Comment 7-2: One commenter wrote that the recommendation to conduct testing for three species of ticks for products applied to dogs and products applied to cats, in addition to testing using specific species for any additional claims of efficacy, results in the use of a large number of dogs and cats in laboratory studies. To align with goals to reduce animal use in testing while protecting the health of animal companions, a comparison of efficacy data for different species of ticks should be undertaken. This evaluation would determine whether one species of tick is the least sensitive to ectoparsiticides, and therefore, if a product controls that species, testing on other species can be avoided. This analysis would consider how the modes of action of different active ingredients may affect the results. For products making claims for ticks and fleas, a retrospective analysis could determine whether one type of pest is less susceptible to pesticides and able to fulfill data needs. 
 
Similarly, the ability to extrapolate efficacy data from dogs to cats, or vice-versa, should be analyzed. The data would show whether a product that is effective in one species can predict efficacy in the other species, and, therefore, whether testing on one species could be waived. To inform testing guidelines, the EPA OPP has undertaken similar retrospective analyses previously. 

      EPA's Response: While the rule will include the testing of three tick species as proposed, EPA continues to be open to an analysis and comparison of susceptibility of the different species to inform the most efficient way for registrants to fulfill data requirements.

Comment 7-3: One commenter encouraged EPA to incorporate efforts to encourage the reduction and minimization of animal testing including statistical power, resources/cost, lab availability, bridging between species wherever possible. 

      EPA's Response: Thank you for the comment, however the Agency will continue to follow the current/revised guidelines while also considering any requests on bridging between species on a case-by-case basis.

Comment 7-4: A commenter stated in accordance with industry standards, treated wood products must be resistant to all threats, not just termites. In fact, the primary focus for the wood preservation industry is efficacy against fungal decay. EPA does not address fungi at all in the proposed rule, which further indicates that this rule is not intended for pressure treatment of wood. 

      EPA's Response: Fungus causing wood rot is not a pest covered by this rulemaking; however, this is not intended to imply the exclusion of pests causing damage to pressure treated wood. EPA notes that each registrant must ensure through testing that his product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration, as per 40 CFR §158.400. See EPA's Response to Comment 6-4.

Unit 8. Guidelines/Guidance

Comment 8-1: A commenter proposed that the Series 810 Guidelines be reviewed on a defined timetable, e.g., 3- to 5-year cycle. They added that this would allow EPA, ASPCRO, industry working groups, registrants and the public to reevaluate target pests and testing methods on an on-going basis using the best, most current science.

      EPA's Response: Thank you for your comment, however the process for reviewing test guidelines is outside the scope of this action.

Comment 8-2: A commenter wrote "EPA states that "the guidelines themselves do not impose requirements. Instead they provide recognized methods for conducting acceptable tests, guidance on reporting data, and definitions of terms. Since these are guidance, pesticide registrants are not required to use these guidelines to fulfill data requirements." The commenter has not found this to be the case. The preamble to the Rule continues and states that "applicants may instead seek to fulfill the data requirements by other appropriate means or by using a non-guideline protocol," The commenter added that their "experience is that any deviation from the guidelines is grounds for deeming the data generated Unacceptable". 

      EPA's Response: The Office of Chemical Safety and Pollution Prevention test guidelines serve as a compendium of accepted scientific methodologies for research intended to provide data to inform regulatory decisions under the Toxic Substances Control Act, FIFRA, and/or the FFDCA. These documents provide guidance for conducting appropriate tests, and are also used by EPA, the public, and the companies that are required to submit data under FIFRA. These guidelines are not binding on either EPA or any outside parties, and the EPA may depart from them were circumstances warrant and without prior notice. The methods described in these guidelines are strongly recommended for generating the data that are the subject of the guidelines, but EPA recognizes that departures may sometimes be appropriate. You may propose alternatives to the methods described in these guidelines, with supporting rationale. The Agency will assess them for appropriateness on a case-by-case basis. 
      
Comment 8-3: One commenter expressed concern about insufficient clarity between the guidance of PR-2002-1 (or the Draft Guidance for Pesticide Registrants on the List of Pests of Significant Public Health Importance, 85 FR 70146, November 4, 2020) and this proposal. The commenter requested that additional clarity or a formal process be included to foster public comment or stakeholder engagement.

A commenter wrote "For pests of public health importance, we are supportive of codifying the pests of public health importance and agree with the inclusion of pests from PRN 2002-1. However, we recognize that pests of public health significance will evolve over time so request clarity on how the list will be updated to include emerging public health pests. We request a clear process for reviewing and, if needed, updating the list at least every five years. The addition of pests of public health significance, should be a collaborative process with stakeholder engagement that includes a broad range of scientific expertise, public health stakeholders, and registrants."

The commenter expressed support for a public process for adding new pests to EPA's List of Pests of Significant Public Health Importance. They added that it is helpful to have a clear understanding of pests for which EPA requires data, and because new pests are constantly emerging, it is critical that EPA can add pests to this list quickly. The commenter also added that a public process that allows for stakeholder input into which pests should be added to the list will ensure they are comprehensive and reflective of current needs.

      EPA's Response: Thank you for your comment, however the process for updating the list to include emerging public health pests is outside the scope of this action. The Agency will continue to actively involve stakeholders and the public in the Agency public participation process when the list for pests of significant public health importance is updated. 
      
      EPA notes that an update of that list was recently made available for public comment and the Agency is currently reviewing the comments received. EPA does have the latitude to identify and request data not listed in subpart R when such data is necessary to make the requisite findings under FIFRA (see 40 CFR 158.30 and 40 CFR 158.1700). 

      EPA also notes that PR Notices are intended to provide guidance to EPA personnel and decisionmakers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, the PR Notice is not binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation. The pests identified in PR Notice 2002-1 are pests of significant public health importance. The list is derived from the review of the pesticide/pest combinations for which efficacy (product performance) data are required to be submitted and reviewed prior to registration. This should not be interpreted to mean that EPA has or would base any regulatory action solely on this list.
      
      Both the PR Notice and the proposed rule provided opportunities for formal comment and stakeholder engagement. PR Notices, which are published in the Federal Register, provided a 60-day public comment period and the proposed rule provided a 60-day public comment period.

Comment 8-4: One commenter encouraged the Agency to publish updated guidance for stakeholder comment to bring further refinement. In particular, guidance on data analysis,
including the type of statistical analysis that should be utilized when analyzing efficacy data, along with the ability to bridge data under this rule, would be helpful to registrants and likely to efficacy reviewers. The commenter wrote that additional guidance is needed on the development of efficacy protocols and the ability to use publicly available, peer-reviewed data and foreign studies to supplement efficacy claims. Overall, the development of practical and relevant guidance documents would contribute to enhanced comprehension of the rule's requirements and promote consistent application of the rule's requirements, which would be beneficial to both efficacy reviewers and registrants.

      EPA's Response: Thank you for your comment, however the process for updating or developing additional guidance is outside the scope of this action. Please note that these are the types of things that we are including in the revised guidelines.


