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Small Business Panel on Reconsideration of Exemptions for Insect Repellents

What is the Proposed Modification to the Insect Repellents Exemption?

EPA is developing a proposal to modify the current exemption from registration under 40 CFR 152.25(f) to remove skin-applied insect repellent products from the exemption. The current exemption was established by EPA in March 1996 under FIFRA §25(b) authority. 40 CFR 152.25(f) exempts from FIFRA pesticide products that pose minimum risks to humans and the environment, provided - among other considerations - that the pesticide product is composed of certain specific ingredients and that the product label does not claim effectiveness against insects or other pests that carry specific diseases.

The changes under consideration are intended to safeguard public health by assuring that minimum risk skin-applied insect repellent products perform effectively, and users receive protection from insects or ticks that may transmit serious diseases. EPA is evaluating options for how to register and review these products.

What is a Small Business Advocacy Panel?

EPA has initiated a Small Business Advocacy Review (SBAR) Panel for the development of a proposed rulemaking to modify exemptions from regulation for minimum risk skin-applied insect repellents for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The Regulatory Flexibility Act as amended by the Small Business Regulatory Enforcement Fairness Act (RFA/SBREFA) requires EPA to convene a SBAR Panel for a proposed rule unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The Panel process offers an opportunity for small entities that are directly affected by a proposed rule to provide input into the rulemaking process in order to ensure that small entity concerns are carefully considered by the agency. Small entities that participate in the Panel process are referred to as Small Entity Representatives.

How Can I Learn More?

If you are a small manufacturer of skin-applied minimum risk insect repellents currently exempted under 40 CFR 152.25(f), you may potentially be affected by this rulemaking. While the opportunity to participate in this Panel has passed, you will have the chance to submit comments concerning this rulemaking during the standard public comment period commencing after publication of the notice of proposed rulemaking in the Federal Register.

Semiannual updates about the development status of the rulemaking are available on both:

Regular updates to pesticide-related activities are available on EPA's Pesticides page.

 

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