(a) General. Each applicant must ensure through testing that their product is efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency may require, as specified herein and on a case-by-case basis, submission of product performance data for any pesticide product registered or proposed for registration or amendment.

(1) Test substance. All product performance testing is performed using the end-use product.

(2) Test organism. All product performance testing must report the species tested.

(3) Testing. All products are to be tested to support the claim(s) made on the labeling of the pesticide product.

(4) Data requirements. To determine the specific product performance data required to support the registration of each pesticide product, the applicant must refer to the applicable sections of this subpart.

(b) Product performance data submission. Each product that bears a claim subject to this subpart, must be supported by submission of product performance data, as listed in this subpart. This product performance data must be submitted with any application for registration or amended registration. For the pest-specific claims listed in this subpart, data must be for the species specified to support the claim. For pests listed as part of a group or subgroup, pest-specific data would also need to be submitted to support a pest-specific claim.

Definitions. The following terms are defined for purposes of this subpart.

Complete protection time (CPT) means the time from application of a skin-applied insect repellent until efficacy failure, which is described in Product Performance Test Guideline 810.3700.

Introduction means the intentional or unintentional escape, release, dissemination, or placement of a species into an ecosystem as a result of human activity.

Invasive species means with respect to a particular ecosystem, any species that is not native to that ecosystem, and whose introduction does or is likely to cause economic or environmental harm or harm to human health.

Performance standard means a benchmark or reference against which the efficacy of the pesticide is compared (including, but not limited to, the ability of the pesticide product to control, kill, or repel an invertebrate pest species).

Pest group labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a group of related species or taxa demonstrating adequate similarity in basic biology and life history characteristics to permit identification of representative test species for the entire assemblage of taxa.

Pest-specific labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a particular arthropod species, such as German cockroach or house fly.

Pest sub-group labeling claim means a claim or statement on the labeling of the pesticide product that the product is effective against a set of related species or taxa demonstrating adequate similarity in basic biology and life history characteristics to permit identification of representative test species and part of a larger identified taxonomic grouping (e.g., Biting flies) that includes other pest species, which may or may not have a specified pest group.

Skin-applied insect repellent means a product intended to disrupt the host-seeking behavior of insects or other arthropods, driving or keeping them away from treated human skin. The repellent product, such as a liquid, lotion, or spray, is intended to be applied directly to human skin. Efficacy of skin-applied insect repellents is expressed as complete protection time.

Species means a group of organisms all of which have a high degree of physical and genetic similarity, generally breed only among themselves, and show persistent differences from members of allied groups of organisms.

Wood-destroying applies to pests that feed on or nest in wood, and therefore are highly destructive to wood buildings or structures, and stored lumber.

Vector means any organism capable of transmitting the causative agent of human and/or animal disease, including but not limited to mosquitoes and ticks.

The following terms are defined for purposes of this subpart.

Bait treatment means a pesticide product intended to be ingested by the target pest that kills or controls an invertebrate pest such as ants, cockroaches, or termites. This is normally through the insect feeding on the product directly, but may also include products which the target will contact and later ingest during grooming/cleaning. The attractiveness of these products is through the use of a palatable food base, however they may also incorporate an attractant (e.g., pheromone) which is intended to attract the target pests over a greater distance.

Soil-applied termiticides means pesticide products that are applied to the soil beneath and/or adjacent to the structure, pre- or post-construction, to kill or control termites. Treatments can be preventive (i.e., to provide structural protection before a termite infestation is present) or remedial (i.e., to kill and control a termite infestation when present).

Spatial repellents include treatments of both indoor and outdoor sites where the product is applied into the air rather than onto a surface or the skin in order to drive away insects or other arthropods from that space. They are intended to repel the target pest through the dispersal of pesticide into the atmosphere of a room or other open space.

Structural protection means the prevention of termite or other wood-destroying pest activity in an entire structure as the result of an application of a pesticide product.

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

(a) General. The claim stated on the pesticide product labeling (such as knockdown, control, mortality, or repellency) determines the performance standard that must be met. In the absence of specific pest/labeling claims/performance standards specified in §§ 158.1708 through 158.1786, the performance standards of paragraphs (b) and (c) of this section apply.

(b) Skin-applied insect repellent labeling claims. (1) For skin-applied insect repellent labeling claims, the performance standard must be greater than or equal to 2-hours complete protection time.

(2) Any testing required under this part which involves any human subjects must comply with all applicable requirements under 40 CFR part 26. For example, 40 CFR part 26 requirements are pertinent to the part 158 testing requirement if the testing involves intentional exposure of human subjects. Protocols for such testing must be submitted to EPA for review prior to study initiation. Those protocols determined by EPA to involve intentional exposure of human subjects also require review by EPA's Human Studies Review Board (HSRB)) prior to study initiation. If you are uncertain about the applicability of the 40 CFR part 26 requirements to this 40 CFR part 158 testing requirement or uncertain about the nature of your planned testing (such as, for example, whether the testing would involve intentional exposure of human subjects or whether the testing would be an observational study), you should contact the Agency prior to initiating the testing.

(c) Labeling claims for products other than skin-applied insect repellents. Unless otherwise specified in §§ 158.1712 through 158.1786, a minimum performance standard of 90 percent is required, except skin-applied insect repellents as specified in paragraph (b) of this section, and non-wearable spatial repellents, where a minimum performance standard of 75 percent is required.

EPA has published the Harmonized Test Guidelines, which set forth the recommended approach to generate the data required in this subpart. The Product Performance Guidelines (Series 810, Group C—Invertebrate Control Agent Test Guidelines) are available on the Agency's website. These guidelines cover some, but not all, of the tests that would be used to generate data under this subpart. In instances where there is a conflict between one of the Harmonized Test Guidelines and the provisions of this subpart, this subpart will control.

The data requirements (including the performance standards associated with the data requirements) specified in this subpart as applicable to a category of products will not always be appropriate for every product in that category. Data requirements may, on a case-by-case basis, be modified by EPA in response to requests for novel technologies or products that have unusual physical, chemical, or biological properties or atypical use patterns which would make a particular data requirement, or data performance standard, inappropriate. Requests for such data requirement modifications must be submitted in the same manner as waiver requests submitted under 40 CFR 158.45. EPA will respond in writing to those requests. The Agency may grant the request if it finds such modifications are appropriate for the pesticide in question, and will ensure that sufficient data are available to make the determinations required by the applicable statutory standards.

(a) General. In addition to those species specified in paragraph (b) of this section, if an application for registration or amended registration requests a labeling claim for effectiveness against an invasive invertebrate species, then on a case-by-case basis, EPA may require submission of product performance data and establish performance standards for those data to support those claims for effectiveness.

(b) Specific. Applications for registration or amended registration requests for a labeling claim for the emerald ash borer, Agrilus planipennis, or Asian longhorned beetle, Anoplophora glabripennis, must be accompanied by product performance data to support those claims for effectiveness.

If an application for registration or amended registration requests a labeling claim specific to a disease vector (such as repels mosquitoes that may carry West Nile virus), then submission of test data conducted with the species specific to the disease vector claim and meeting the specific performance standard for that species is required even if the disease vector species is not the test species required in §§ 158.1712 through 158.1786.

If an application for registration or amended registration requests a labeling claim specific to a structural or wood-destroying pest not identified in §§ 158.1782 through 158.1786, EPA may require submission of product performance data, with testing on that specific pest and subject to specific performance standards, to support those claims for effectiveness.

(a) General. The tables and test notes in this section apply to dust, human itch or scabies, and dog follicle mites. The claim stated on the pesticide product labeling determines the required test species. The required test species for a specific type of mite claim appear in paragraph (b) of this section and the required performance standards appear in paragraph (c) of this section.

(b) Test species. For pesticide products making a claim against mites, the required test species appear in the following table.

(c) Performance standards. (1) For the dog follicle mite, the performance standard is 100 percent.

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

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

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

(b) Test species. For pesticide products making a claim against ticks, the required test species appear in the following table.

(c) Specific parameters. The following parameters are required.

1. For products applied to dogs, testing is required on three species: Blacklegged tick (Ixodes scapularis), American dog tick (Dermacentor variabilis), and Brown dog tick (Rhipicephalus sanguineus).

2. For products applied to cats, testing is required on three species: Blacklegged tick (Ixodes scapularis), Lone star tick (Amblyomma americanum), and American dog tick (Dermacentor variabilis).

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

(a) General. The table in this section applies to spiders. The product labeling claim determines the required test species. The required test species for spider labeling claims appear in paragraph (b) of this section.

(b) Test species. For products making a claim against spiders, the test species for labeling claims appear in the following table.

(a) General. The table in this section applies to centipedes. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of the section.

(b) Test species. For products making a claim against centipedes, the required test species for a labeling claim is set forth in the following table.

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

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

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

(a) General. The table in this section applies to fleas. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section.

(b) Test species. For products making a claim against fleas, the required test species for a labeling claim is set forth in the following table.

(a) General. The table in this section applies to cockroaches. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section.

(b) Test species. For products making a claim against cockroaches, the required test species for a labeling claim for cockroaches and the test species for pest-specific label claims appear in the following table.

(a) General. The table in this section applies to keds, screwworms, and bot flies. The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section.

(b) Test species. For products making a claim against keds, screwworms, and bot flies, the required test species for a labeling claim appear in the following table.

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

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

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

(b) Test species. For products making a claim against mosquitoes, the required test species for a labeling claim is set forth in the following table.

(a) General. The table in this section applies to bed bugs. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section.

(b) Test species. For products making a claim against bed bugs, the required test species for a labeling claim appear in the following table.

(a) General. The table in this section applies to Conenose bugs and Kissing bugs. The product labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section.

(b) Test species. For products making a claim against either the conenose and/or kissing bugs, the required test species for a labeling claim is set forth in the following table.

(a) General. The table in this section applies to ants (excluding carpenter ants). The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section.

(b) Test species. For products making a claim against ants (excluding carpenter ants), the required test species for a labeling claim appear in the following table, unless otherwise specified in paragraphs (c) or (d) of this section. The group and sub-group claims in this paragraph are for direct kill and residual surface application claims against foraging ants only (excluding colony claims).

(c) Colony Claims. For colony claims, testing must be done for each species listed or each representative species, in the case of a group. For colony claims against the red and/or black imported fire ants, testing may be done on, S. invicta, S. richteri, or their hybrid.

(d) Bait products or claims involving outdoor use. The group and sub-group claims in paragraph (b) of this section are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). For bait products or claims involving outdoor use, testing must be specific to the species listed or each representative species, in the case of a group.

(a) General. The table in this section applies to bees, wasps, yellowjackets, and hornets. The labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section.

(b) Test species. For products making a claim against bees, wasps, yellowjackets, and hornets, the required test species for a labeling claim appear in the following table, unless otherwise specified in paragraph (c) of this section.

(c) Colony claims. For colony claims, except Vespula spp., testing must be specific to the species listed. Acceptable data for any Vespula species may support a yellowjacket colony claim for ground nesting Vespula species; however, species-specific claims need to be supported by data from testing of the specific species. Colony claims have a performance standard of 100%.

(a) General. The table in this section applies to carpenter ants. The product labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section.

(b) Test species. For products making a claim against carpenter ants, the required test species for a labeling claim appear in the following table. The group and sub-group claims in this paragraph are for direct kill and residual surface application claims against foraging ants only (excluding colony claims).

(c) Performance standards. The performance standards for pesticide products making certain claims against carpenter ants appear in the following table and in paragraphs (d) and (e)of this section. The performance standards for labeling claims not covered in this section appear in § 158.1704.

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

(e) Bait products or claims involving outdoor use. The group and sub-group claims in paragraph (b) of this section are for direct kill and residual surface application claims against foraging ants only (excluding colony claims). For bait products or claims involving outdoor use, testing must be specific to the species listed or each representative species, in the case of a group.

(a) General. The tables and test notes in this section apply to wood-destroying beetles. The labeling claim determines the required test species. The required test species for a labeling claim appears in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section.

(b) Test species. For products making a claim against wood-destroying beetles, the required test species for a labeling claim is set forth in the following table.

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

(a) General. The tables and test notes in this section apply to the subterranean termite, desert subterranean termite, Formosan subterranean termite, drywood termite, and dampwood termite. The labeling claim determines the required test species. The required test species for labeling claims appear in paragraph (b) of this section. The required performance standards appear in paragraph (c) of this section.

(b) Test species. For products making a claim against termites, the required test species for a labeling claim appear in the following table. For the structural protection and wood preservative claim categories, a claim against any specific genus of subterranean termite must be supported by data on that individual genus and all the required test genera for a subterranean termite claim must be tested and submitted.

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