The EPA has taken final action to remove 72 entries from the list of inert ingredients approved for use in pesticide products. Inert ingredients on this list do not need further approval before inclusion in a pesticide formulation for a nonfood use.
 |
The Agency says it has no documentation showing that any of the inert ingredients removed from the approved list are being used in currently approved pesticide product formulations. Once an inert ingredient is removed from the approved list, an entity that wants to include that ingredient in a pesticide product would need to provide the EPA with the same information the Agency would require as part of a submission request to add a new inert ingredient to the approved list. That information may include studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, and genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.
Pesticide products contain both active ingredients and inert ingredients. An active ingredient acts to control pests. Inert ingredients typically facilitate the delivery of the active ingredient to the target organism. Inert ingredients include emulsifiers, solvents, carriers, aerosol propellants, fragrances, and dyes. Inert, as that word is used in pesticide regulations, can be a misleading term since many inert ingredients are toxic to people and animals and have adverse environmental impacts.
Petition for Disclosure
This final action responds to a 2006 petition sent to the EPA by several environmental groups and Kamala Harris, California’s attorney general, who will soon begin her first term as a U.S. senator. The petitioners requested that the EPA require that the identities of inert ingredients appear on pesticide labels. While the EPA was initially receptive to this request, the Agency ultimately decided that the effectiveness of such an action would be limited by the laws that protect trade secrets. The EPA told the petitioners that other voluntary and regulatory actions could be taken to address the risk posed by inert ingredients, including shrinking the list of approved ingredients.
The EPA proposed its removal list in October 2014 and requested public comment. In the preamble to the final action, the Agency says it received no specific information showing that any entry on the proposed list is currently being used in pesticide product formulations. The list of 72 inert ingredients being removed from the approved list is available at https://www.regulations.gov; docket EPA-HQ-OPP-2014-0558.
Cost of Reinstatement
In comments on the rulemaking, the American Chemistry Council (ACC) expressed concern that the EPA may be mistaken in its belief that none of the 72 inert ingredients are currently used in pesticide formulations. The ACC noted that the consequence of delisting an ingredient that is, in fact, in use is that the owner of the pesticide registration will need to complete studies at a cost of over $5 million to reinstate approval.
The ACC also noted that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), risk, not nonuse, should be the criterion for removing an inert ingredient from the approved list. The EPA disagreed.
“FIFRA does not state a standard for approval of an inert ingredient, specifying only the fee category and review time,” says the EPA. “While the statute incorporates the risk of unreasonable adverse effects on the environment as one of the factors in granting registration for an individual pesticide produce under FIFRA section 3, no such criteria apply to approval of an inert ingredient.”
The Agency’s final action was published in the December 14, 2016, FR.