We use data generated by environmental degradation studies to: The proposed rule (86 FR 15362, March 22, 2021) (FRL-10011-06) provided detailed background information on the pesticide registration process, the existing legal framework, the importance of product performance data, and the relationship between these regulations and other guidelines (see proposed rule pages 15365-15368). This section briefly summarizes this information. (b) Transmission of product performance data. Any product that is the subject of a claim covered by this subsection must be supported by the submission of product performance data as set out in this subsection. This product performance data must be submitted with each amended application for registration or registration. For information specific to the pests listed in this subsection, data on the species indicated in support of the claim shall be available. For pests included in a group or subgroup, pest-specific data should also be provided in support of a pest-specific claim. The EPA is requesting the submission of acute oral inhalation toxicity and acute toxicity study data in conjunction with GHS calculations to support the evaluation of pesticide product formulations. The GHS dose additive mixture equation, which is used to classify the toxicity of mixtures based on available data on the individual ingredients they contain, could be an alternative to animal testing using pesticide formulations. The Ontario Provincial Police will use the submissions from this pilot project to assess the benefits and acceptance of the equation for ghsc dose additive mixtures as an alternative to oral and inhaled toxicity studies for pesticide formulations. For information on submitting data for the pilot and a sample submission template, see our Mixing Equations Pilot Program page.
Bait treatment refers to a pesticide to be ingested by the target pest, which kills or controls an invertebrate pest such as ants, cockroaches or termites. This is usually done by direct feeding insects from the product, but can also include products with which the target comes into contact and is then picked up during care/cleaning. The appeal of these products lies in the use of a tasty food base, but they can also be an attractant (for example, Pheromone), which is intended to attract target parasites over a greater distance. Another test is available for certain aspects of the chemical requirements of the product: if an application for registration or modified registration requires labelling specific to a disease vector (e.g. repels mosquitoes that may be carriers of West Nile virus), it is necessary to provide test data carried out with the species specific to the indication of the disease vector and the specific performance standard for that species, even if the disease vector species does not respond to the test types according to §§ 158.1712 to 158.1786. The EPA has developed pest groups and subgroups with the goal that product performance testing on a particular species can adequately represent a claim against the general group or subgroup. The Agency intends that these groups of pests reduce the burden of submitting data to applicants and the burden of verifying data for the Agency, and that they increase the consistency, reliability and integrity of data submitted to the EPO. (a) General. The table and test instructions in this section apply to hard ticks (including bovine ticks) and soft ticks. The indication on the pesticide label determines the types of tests required. The types of testing required for a particular type of tick indication are listed in point (b) of this section. The specific parameters applicable to individual tests are listed in point (c) of this Section.
For a claim against a particular type of “tick”, it is necessary to test these individual species and all representative species listed for “ticks”, but not the representative species for bovine ticks or soft ticks. Claims against ticks in relation to tick-borne diseases are also subject to the requirements of § 158.1709. (a) General. The tables and test instructions in this section apply to mosquitoes. The types of tests required for mosquito labelling are listed in point (b) of this section. For a claim against a particular mosquito species, these individual species and all required test genera must be tested. Claims against mosquitoes related to mosquito-borne diseases are also subject to the requirements of § 158.1709. Structural pests differ from pests of significant public health importance because the health of individuals is not endangered. However, the effectiveness of the treatment is not easily apparent to the applicator at the time of application or during the occupancy of the building or house, and there is a possibility of significant financial loss for the owner. The EPA has generally required the filing of product performance data for wood-destroying insects for more than 40 years. Similarly, invasive invertebrates can incur serious economic costs by causing or transmitting diseases against native species that have little or no natural defenses.
Invertebrates such as the emerald ash borer and the Asian longhorned beetle kill trees in very large geographical areas, which has a significant environmental and economic impact by destroying both urban cover and recreational forests and wood stands. The EPA requires applicator and user exposure data for all pesticides to assess potential risks to people who use the pesticide, that is, those who may be exposed to higher concentrations of the pesticide through handling, including mixing or application. (4) Data requirements. In order to determine the specific product performance data required to support the registration of each pesticide, the applicant shall refer to the relevant sections of this Subpart. Respondent`s obligation to respond: Mandatory. This data must be submitted in order for the applicant to receive registration or labelling of the desired pesticide. Permit legislation is contained in FIFRA Section 3 (7 U.S.C. 136). Implementation rules specific to product performance data requirements are contained in Part 158 of 40 CFR. A pest-specific labelling indication is an indication or statement on the labelling of the pesticide product indicating that the product is effective against a specific species of arthropod such as a German cockroach or a housefly. The invertebrate species of significant public health significance identified in this rule as carriers of product performance data are from the list of harmful invertebrates listed in PR Notice 2002-1, a draft update published for comment in 2020 (Ref. 2).
These harmful invertebrates pose a threat of injury, transmission of diseases and/or pathogens, and production of allergens. They can have toxic bites or bites and transmit serious diseases such as Rocky Mountain spotted fever, Lyme disease, ehrlichiosis, West Nile virus, dengue, malaria, encephalitis, yellow fever, chikungunya fever and Zika virus. Short-term acute and subacute laboratory tests provide basic toxicity information that serves as a starting point for risk assessment. This data will be used to: As noted in the preamble to the proposed rule, the provisions of 40 CFR 158.75 and 40 CFR 158.1708 would allow the EPA to request pest-specific data on a case-by-case basis if necessary to evaluate a pesticide product. These provisions allow the EPA to meet the Agency`s data needs in light of emerging concerns about invertebrates. In addition, as proposed, the EPA is finalizing provisions that would require group testing for mosquitoes and ticks in order to make a claim against parasites within these groups. This final rule sets out the product performance data requirements for the harmful invertebrate categories specified in PRIA 4 and is therefore intended to meet the above rule-making requirements. The EPA notes that this final rule covers certain invertebrate pests in addition to the pests specified in priA 4 because of its importance to health, the economy, or the environment (e.g., wood-destroying insects). CEPOL has published the harmonised test guidelines which define the recommended approach for generating the data required in this subsection.
Product performance guidelines (Series 810, Group C – Guidelines for Testing Invertebrate Control Agents) are available on the agency`s website. These guidelines cover some, but not all, tests that would be used to generate data under this subsection. In the event of any conflict between any of the harmonised test guidelines and the provisions of this Subsection, this Subsection shall prevail. The EPA has provided additional guidance on data requirements under Part 158W, including a letter to pesticide registrants describing how we implemented 158W.