EPA Targets 72 Inert Pesticide Ingredients for Removal
On October 22, 2014, the U.S. Environmental Protection Agency (EPA) issued a Federal Register Notice proposing to remove 72 chemicals from the list of currently approved inert pesticide ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. (“Proposed Removal of Certain Inert Ingredients From Approved Chemical Substance List for Pesticide Products,” 79 Fed. Reg. 63,120.) According to the Notice, EPA has selected these chemicals in response to petitions filed in 2006 requesting that the Agency require disclosure of 371 inert ingredients on the labels of pesticide products in which they are present on the basis that they are hazardous. Comments are due to EPA on the notice by November 21, 2014. If any of the ingredients on EPA’s list are in your registered product, you need to file comments by the deadline.
EPA issued a partial response to these petitions on May 22, 2014, stating that it would not initiate a rulemaking to require disclosure “in the absence of data or information clearly indicating that a rule requiring disclosure, but not otherwise affecting the composition or use of a pesticide product, would result in a significant reduction in the human health or environmental risks posed by the presence of inert ingredients in pesticide products.” (Letter from James Jones, EPA Assistant Administrator, to the Honorable Kamala Harris, Attorney General of the State of California, et al., dated May 22, 2014.) EPA is, however, considering a variety of other actions to reduce the presence of potentially hazardous inert ingredients in pesticide products. One such action is the October 22, 2014, proposal to delist 72 chemicals identified in the petitions, which EPA believes are no longer in use as part of approved pesticide formulations.
Under FIFRA, once an inert ingredient has been approved for use in a pesticide, additional uses in non-food applications are not subject to any registration requirements. Accordingly, once delisted, any future use of the chemical as an inert ingredient in a pesticide would require the submission and review of data prior to EPA approval. “The type of data needed to evaluate a new inert ingredient may include, among others, studies to evaluate potential carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity as well as environmental effects associated with any chemical substance that is persistent or bioaccumulative.” (79 Fed. Reg. 63,121.) These data requirements can be costly and for this reason, companies should examine the list closely to ensure their products do not contain any of the listed ingredients. Indeed, we believe that EPA does not have a master list of all the ingredients in currently approved confidential statements of formula (CSFs), so there is no easy way to determine whether these inert ingredients are inactive, approved pesticide products. Thus, EPA’s belief that the substances are not being used simply means that no one with a role in producing the list recalled seeing any of the substances in recent CSF submissions.
The substances on the list include some common organic solvents like methyl ethyl ketone and tetrahydrofuran, a number of phthalate derivatives, nonylphenol, and some inorganic compounds. Some of these compounds may still find uses in specialty pesticides like antifouling coatings.
Other actions EPA is considering include risk assessments on high-priority, non-food use inert ingredients. EPA is focusing on non-food use inert ingredients because it completed a statutorily-mandated reassessment of the tolerances established for food-use inert ingredients in August 2006. EPA would evaluate each high-priority inert ingredient on a case-by-case basis to determine what combination of voluntary and/or regulatory actions would be most appropriate to reduce potential risks.
Related Article:
EPA Office of Pesticide Programs – Removal of Certain Inert Ingredients from Approved Chemical Substance List – Extension of Comment Period
Keller and Heckman LLP is available to assist registrants that may be affected by this Notice. You can review the list of chemicals available here, or by visiting Regulations.gov, and searching for docket “EPA-HQ-OPP-2014-0558.” If a registrant has any inert ingredient proposed for removal in a current formulation, the Registrant should notify EPA in writing not later than November 21, 2014. Notices should be sent to EPA’s designated contact, Kerry B. Leifer, Registration Division, Office of Pesticide Programs, at (703) 308-8811or leifer.kerry@epa.gov. In addition, Keller and Heckman LLP’s Pesticides Practice Group is available to counsel clients on FIFRA compliance and can be reached at 202-434-4100.