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EPA Announces Data Compensation Obligations and Tolerance Revocations for Pesticide Inert Ingredients (March 2012)

The first group of 67 chemicals identified for Tier 1 Endocrine Disruptor Screening Program (EDSP) includes 58 pesticide active ingredients and nine High Production Volume (HPV) chemicals used as pesticide inert ingredients. In January and February of 2010, EPA issue EDSP test orders to manufactures of acetone, isophorone, di-sec-octyl phthalate, toluene, methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate.

A Federal Registrar notice from March 14, 2012 explains how EPA will enforce data compensation obligations for the eleven screening assyas for two of the nine inerts (acetone and isophorone) and that EPA will remove five of the unsupported inerts from its list of approved inerts (methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate). A second Federal Register notice from March 14, 2012 proposes to revoke existing exemptions from the requirement of a tolerance for residues of two of the five unsupported inerts (diethyl phthalate and methyl ethyl ketone).

Pesticide registrants whose products contain acetone and isophorone as active ingredients should be conscious of their data compensation obligations to the two consortia if they source from a non-member. Additionally, all registrants should be aware that EPA is planning to remove the five unsupported pesticide inert ingredients from its list of approved inert ingredients and that the Agency is intending to repeal the FFDCA exemptions from tolerances for diethyl phthalate and methyl ethyl ketone.

Data Compensation Obligations Owing to Consortia for Their Generation of Tier 1 Screening Assays for the Pesticide Inert Ingredients Acetone and Isophorone: Assays are being developed for two of the nine inerts, acetone and isophorone, in response to the EDSP test orders. The Agency did not receive commitments to develop inerts for the other seven. EPA will issue new test orders for di-sec-octyl phthalate and toluene because these chemicals meet the criteria for endocrine testing under the Safe Drinking Water Act. However, there are no plans to issue further testing for the remaining five inerts: methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate. These will be removed from the lists of approved inert ingredients six months after the date EPA publishes as a final rule revoking the tolerances for diethyl phthalate and methyl ethyl ketone.

EPA’s Notice advises that if a Confidential Statement of Formula (CSF) lists a source of isophorone or acetone other than a consortia member, EPA will require the registrant to take one of the following actions:  i) change its source to a consortia member, (ii) submit proof of an offer to pay (“OTP”) to the consortia, (iii) submit a commitment to generate the required data, (iv) reformulate their formulation (presumably using another approved inert and for which there is an exemption from tolerance if a food use) or (v) cancel the registration. 

EPA’s Proposed Revocation of Tolerance for Diethyl Phthalate and Methyl Ethyl Ketone: EPA previously established exemptions from tolerance for two of the five unsupported inerts: diethyl phthalate and methyl ethyl ketone. As stated in the second Federal Register notice from March 14, 2012, because no manufacturer or importer committed to generate the Tier 1 EDSP screening assays for the two inerts, EPA is proposing to revoke their exemptions. This will become effective six months after the final revocation rule is published in the Federal Register.

The proposed rule is offering a final opportunity for any interested parties to commit to providing this data and explains that if any party anticipates rejecting the final revocation rules that they must raise their concerns in comments on this proposal.

Deadline for submitting comments is May 14, 2012.

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