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Estimated Total Load: This rule is expected to reduce effort by 4,683 hours per year, including 4,515 hours due to reduced paperwork associated with data generation and 168 hours due to reduced paperwork associated with the application process. The load is defined in 5 CFR 1320.3(b). CEPOL already takes into account the activities related to the rule in the currently approved CI, which covers most activities related to new and amended registrations; The LFS estimates the total annual burden of respondents at 1.5 million hours for all of these activities. As noted in the supporting statement (Ref. 5), 483,000 of these hours are records from data generation for new products, and 102,000 of these hours are records from the application for new and modified products. Additional studies (i.e. reproduction of birds, fish and invertebrates; Life cycle studies and plant field studies) may be required if baseline data and environmental conditions indicate potential problems. Data from these studies will be used to: If an application for registration or amended registration requires a label specific to a disease vector (e.g. repel mosquitoes that may carry West Nile virus), it is necessary to provide test data performed with the species specific to the indication of the disease vector and meeting the specific performance standard for that species, even if the type of disease vector is not the type of test required in §§ 158.1712 until 158.1786. The EPA received several comments and questions about how the Agency intends to implement the rules. These comments included proposals for a more defined procedure to cover invasive alien species, questions about exemptions or changes to these data requirements, and questions about the status of existing pesticide products.

(b) product performance data for each device that is the subject of a claim against an invertebrate pest referred to in Subdivision R of this Part. The product performance data and performance standard requirements in Subsection R of this Part apply to biochemicals covered by this Subsection. Product performance data must be submitted with each amended application for registration or registration. However, the data requirements and performance standards that determine the acceptance of the data may be waived or amended on a case-by-case basis in accordance with the waiver provisions of § 158.45 and the amending provisions of § 158.1707. While not all elements of the rule result in savings for registrants, the EPA cautiously estimates that the rule will result in an annual reduction of $1 million in registrants` expenses to obtain label claims against public health, wood destruction and harmful invasive species, resulting in savings of approximately $17,000 per data package submitted to the agency and approximately $5,500 per registrant. in annual savings. Compliant. I have therefore concluded that this measure will reduce the administrative burden on all directly regulated small businesses. The basis for this determination is presented in the analysis of small entities (ref. 1) prepared as part of the cost analysis of this rule, which is summarized in Unit I.E., and a copy is available in the file for the development of this rule. We therefore concluded that this measure will reduce the regulatory burden on all directly regulated small businesses. As mentioned above, FIFRA requests the Agency to register pesticides, including those used against invertebrates of public health importance, invertebrate wood-destroying pests and invasive pests of invertebrates, under conditions of use such that the pesticide has a composition that justifies the proposed claims.

To make this decision, the Agency requires registrants to submit data demonstrating the effectiveness of the product against harmful invertebrates of public health importance, invertebrate wood-destroying pests and invasive invertebrate pests. Product performance data requirements that have been requested by the EPA in the past and are usually finalized relate to claims against pests that pose a threat to human health (e.g., mosquitoes and cockroaches) or that have significant economic or environmental impacts against which the use of a pesticide cannot be easily determined by the user (e.g., termites and emerald ash drills). In these situations, market forces may act too slowly to eliminate ineffective products. This final rule codifies the Start Printed data page 22466 Requirements for the support of labelling claims, which were previously established on a case-by-case basis to conduct product performance evaluations. This will provide the necessary clarity for companies that want to develop and market products to control detected pests. You may be affected by this measure if you are a manufacturer or registrant of pesticide products that makes claims against the specified categories of harmful invertebrates. North American Industry Classification System (NAICS) codes are provided to help you and others determine if this promotion may apply to certain businesses. This list does not purport to be exhaustive, but provides readers with a guide to the businesses that may be regulated by this measure. Other types of entities that are not listed could also be affected. Potentially affected companies may include the request for comments on the preliminary draft science policy “Using Alternative Approaches to Skin Sensitization as a Substitute for Laboratory Animal Testing”.

This draft strategy paper describes the science behind humane alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization. The EPA currently needs this data to support pesticide registration. Given the extensive scientific knowledge and international activities in support of new methods of skin sensitization screening, the EPA will immediately begin accepting these approaches under the conditions outlined in the draft policy document. Comments may be submitted until June 9, 2018 by www.regulations.gov in file # EPA-HQ-OPP-2016-0093. (b) Specific. Applications for registration or amended applications for registration of a marking claim for the emerald ash borer, Agrilus planipennis, or the Asian longhorn beetle, Anoplophora glabripennis, shall be accompanied by product performance data to support these efficacy claims. In parallel with this regulation, the EPO has prepared an economic analysis entitled “Cost analysis of the final product performance rule” (ref. 1), which includes an economic analysis of the impact of the codification of data requirements on product performance, as well as the impact of changes to data requirements on labelling claims published at the same time. 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. Section 3 of FIFRA sets out the requirements for granting and maintaining registration. Section 3(c)(2) of FIFRA gives the EPO extensive power before and after registration to require scientific testing and the transmission of the resulting data to the Agency.

As part of this authority, the EPA requires such review and transmission of data through rule-making, see 40 CFR Part 158 or, for existing records, by issuing a “call for data.” (See section 3(c)(2)(B) of FIFRA). The EPA may also request additional data if the data transmitted does not adequately resolve a problem necessary for the necessary legal conclusions. (See 40 CFR 158.75). In accordance with the requirements imposed by the EPA and the data deemed necessary for the review of applications for pesticides of significant health or economic importance, the EPA applicant must provide data on the pesticide, its composition, toxicity, potential exposure to humans, environmental characteristics and impacts, as well as the performance (efficacy) of the product.