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Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Proposed Rules 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 proposed pest group.
Skin-applied insect repellent means a product intended to disrupt the hostseeking behavior of insects or other arthropods, driving or keeping them away from treated human skin. The repellent product, such as liquid, lotion, or spray, is intended to be applied directly to human skin. Efficacy of skinapplied 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 interbreed 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. The impact on the structural integrity of buildings can represent significant economic or safety concerns given the costs of remediation.
Vector means any organism capable of transmitting the causative agent of human and/or animal disease, including but not limited to mosquitoes and ticks.

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158.1703

Application categories.

The following terms are defined for purposes of this subpart.
Bait treatment means a pesticide product intended to be ingested by the target pest that kills or controls an invertebrate pest such as ants, cockroaches, or termites. This is normally through the insect feeding on the product directly, but may also include products which the target will contact and later ingest during grooming/cleaning. The attractiveness of these products is through the use of a palatable food base, however they may also incorporate an attractant e.g.
pheromone which is intended to attract the target pests over a greater distance.
Soil-applied termiticides means pesticide products that are applied to the soil beneath and/or adjacent to the structure, preor 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 wooddestroying pest activity in an entire structure as the result of an application of a pesticide product.
158.1704 Performance standards for data acceptability.

a General. The claim stated on the pesticide product labeling such as knockdown, control, mortality, or repellency determines the performance standard that must be met. In the absence of specific pest/labeling claims/
performance standards specified in 158.1708 through 158.1799, 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
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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 EPAs 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 158.1710 through 158.1786, for pesticides other than skin-applied insect repellents, the performance standard for a product performance claim against a pest must be greater than or equal to 90
percent, except for non-wearable spatial repellents where the performance standard is greater than or equal to 75
percent.
158.1705

Test guidelines.

EPA has published the Harmonized Test Guidelines, which set forth the recommended approach to generate the data required in this subpart. The Product Performance Guidelines Series 810, Group CInvertebrate Control Agent Test Guidelines are available on the Agencys website. These guidelines cover some, but not all, of the tests that would be used to generate data under this subpart. In instances where there is a conflict between one of the Harmonized Test Guidelines and the provisions of this subpart, this subpart will control.
158.1707 Data requirement modifications.

The data requirements including the performance standards associated with the data requirements specified in this subpart as applicable to a category of products will not always be appropriate for every product in that category. Data requirements may, on a case-by-case basis, be 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 the same manner as waiver requests submitted under 40 CFR 158.45. EPA

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