EPA Issues in Final Certain Pesticide Product Performance Data Requirements to Improve Clarity and Reduce Burden for Registrants

On April 15, 2022, the U.S. Environmental Safety Company (EPA) announced last product efficiency knowledge necessities for merchandise claiming efficacy in opposition to sure pests. 87 Fed. Reg. 22464. This motion formally incorporates EPA’s already present product performance standards requirements for sure invertebrate pests into the Code of Federal Laws (CFR).  EPA states this motion additionally will increase the effectivity of its approval course of and will save registrants time and cash.

Product efficiency requirements are meant to make it simpler for pesticide registrants to know the efficacy knowledge that EPA requires to display {that a} pesticide product works as claimed. By including these necessities into the CFR, EPA states that it intends to assist be certain that submitted knowledge meet EPA’s wants and scientific requirements and fulfill a requirement of the 2018 Pesticide Registration Enchancment Extension Act (PRIA 4). EPA notes as a part of the settlement between pesticide stakeholders and public curiosity teams reflecting the environmental and farmworker security communities in the event of PRIA, “PRIA 4 specifically establishes a new maintenance fee set-aside of up to $500,000/year to develop and finalize rulemaking and guidance for product performance data requirements for certain invertebrate pests of significant public health or economic importance. Specific to this rule, PRIA 4 requires EPA to finalize product performance data requirements by September 30, 2021, for certain pesticides intended for preventing, destroying, repelling, or mitigating specified invertebrate pest of significant public health or economic importance.”

This last rule consists of product efficiency knowledge necessities for the classes of invertebrate pests specified in PRIA 4, which EPA states it intends to fulfill the rulemaking requirement. EPA notes that this last rule covers some invertebrate pests in addition to these specified in PRIA 4 due to their public well being, financial, or ecological significance (e.g., wood-destroying bugs).

EPA states that it believes this last rule will save registrants roughly $17,000 per knowledge package deal submitted to EPA by lowering waste and pointless testing, and believes it can cut back burden hours by 4,683 yearly, together with 4,515 hours from diminished paperwork burden related to knowledge technology and 168 hours from diminished paperwork with the applying course of.

This last rule codifies product efficiency knowledge necessities to assist the registration of merchandise claiming efficacy in opposition to three classes of invertebrate pests: 

  • These recognized to be of serious public well being significance (e.g., ticks, mosquitoes, cockroaches);

  • Wooden-destroying bugs (e.g., termites); and

  • Certain invasive invertebrate species (e.g., Asian long-horned beetle).

EPA states that the latter two classes are pests thought-about to be of serious financial or ecological significance.

The ultimate rule is efficient on June 14, 2022.

Commentary

Codifying the product efficiency knowledge necessities for invertebrate pests ought to enhance transparency to registrants concerning the efficacy knowledge that they sometimes would wish to generate and submit for merchandise to make labeling claims in opposition to these particular pests. Registrants of the merchandise at concern ought to monitor these necessities intently.

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