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EPA Announces Proposed Changes for Minimum Risk Pesticides

Beveridge & Diamond, P.C., January 28, 2013

On December 31, 2012, the U.S. Environmental Protection Agency announced a proposal to make several important changes to the exemption for “minimum risk” pesticide products under Section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act.  See EPA, “Pesticides; Revisions to Minimum Risk Exemption,” 77 Fed. Reg. 76979 (Dec. 31, 2012).  Public comments on the proposed changes are due on or before April 1, 2013.

This would be the first set of revisions to EPA’s minimum risk pesticide regulations since the Agency first promulgated them in 1996.  As briefly summarized below, the proposed changes would include more detailed EPA listings of the active and inert ingredients that may be used in minimum risk pesticides, as well as new labeling requirements that would become mandatory two years after the effective date of the final rule.  Although EPA is not proposing to add or subtract any ingredients from its lists of eligible minimum risk product ingredients, the Agency suggests that as many as half of the minimum risk pesticides now marketed may not comply with its current regulations, and acknowledges that the more detailed listings included in its proposal may in effect require manufacturers who currently distribute pesticides under the minimum risk exemption to reformulate their products to achieve compliance.   

If you would like to discuss EPA’s new proposal or if you have any questions about the regulation of minimum risk pesticides more generally, please contact Kathy Szmuszkovicz at Beveridge & Diamond, P.C. (kes@bdlaw.com or (202) 789-6037) or Alan Sachs, Independent Consultant Attorney to Beveridge & Diamond, P.C. (ajs@bdlaw.com or (410) 230-1345). 

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Background

EPA first promulgated 40 CFR Section 152.25(f) in 1996, using its authority under FIFRA Section 25(b) to exempt from FIFRA’s registration requirements pesticide products that contain specific active and inert ingredients that EPA determined pose minimum risk to humans and the environment.  As explained in EPA’s new proposal, determining whether an ingredient on a pesticide label is the same substance referred to in EPA’s regulations has proven time-consuming and confusing over the years -- particularly given the numerous chemical, common, or Latin names that may be associated with a particular substance.

According to EPA’s analysis, nearly half of the subset of 135 personal insect repellent products currently distributed as minimum risk pesticides and reviewed by the Agency contain ingredients not permitted by EPA’s regulations.  Moreover, EPA notes that products that may be exempt from Federal registration as minimum risk pesticides under FIFRA Section 25(b) still face state registration requirements in approximately 37 states and the District of Columbia.  EPA explains that the confusion surrounding which ingredients are permitted in minimum risk pesticide products has also led to inconsistent and ineffective enforcement.

EPA’s Proposal

EPA is proposing to replace the current list of active ingredients found at 40 CFR Section 152.25(f) with a table that would show for each permitted active ingredient:

  1. A specified label display name (the common chemical name that would be required to be used on labels of any products containing these ingredients);
  2. A specific chemical name (as determined by the Chemical Abstract Services, or “CAS”);
  3. Any specifications associated with a substance (as originally included in the Agency’s 1996 regulations);
  4. The associated CAS Registration Number.

EPA also is proposing to codify its list of permitted inert ingredients in a separate table at 40 CFR Section 152.25(f)(2) (currently, permitted inert ingredients may be found in “List 4A” and by reference to other EPA regulations).  In its request for comments, EPA acknowledges that it is “unclear” how the new lists of active and inert ingredients may affect the composition of products; it expresses special interest “in learning of any products that would need to be reformulated as a result of these proposed changes.”  77 Fed. Reg. at 76987.  

Finally, EPA’s proposal includes several new labeling requirements for minimum risk products.  Manufacturers would be required to use the “label display name” of a substance as provided in the new tables, eliminating some of the confusion currently caused by the display on product labels of chemical names derived from a variety of sources.  In addition, EPA proposes requiring labels to provide the producer’s company name and contact information.  If a company name appears on the label and that company is not the producer, EPA further proposes that the text indicate that the product was “packed for,” “distributed by,” or “sold by” the company, to show that the company selling the product is not the producer.  EPA proposes that compliance with these label changes become mandatory two years from the effective date of the final rule.  As explained in the proposal, EPA also considered but decided against a new requirement for labels to include a disclaimer signaling a product’s exempt status.