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March 16, 2012

EPA Announces Results of Inert Ingredient Test Orders Issued under the EDSP

Bergeson & Campbell, P.C.

On March 14, 2012, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice concerning the results from the inert ingredient test orders issued under the Endocrine Disruptor Screening Program (EDSP). In January and February 2010, EPA issued test orders for the following nine chemicals currently used as inert ingredients in pesticide products: acetone; isophorone, di-sec-octyl phthalate; toluene; methyl ethyl ketone; butyl benzyl phthalate; dibutyl phthalate; diethyl phthalate; and dimethyl phthalate. The test orders required recipients to submit specific screening data on hormonal effects under the EDSP and the Federal Food, Drug, and Cosmetic Act (FFDCA). As a result of responses (or lack of responses) received, EPA is: removing five of the inerts from its list of approved inert ingredients (and revoking tolerances for two of these five); informing companies about testing consortia formed to develop EDSP data for two of these inerts and resulting data compensation obligations; and issuing new test orders for two inerts that meet the criteria for EDSP testing under the Safe Drinking Water Act (SDWA). Comments are due May 14, 2012.

In response to the test orders, companies agreed to develop data and asserted data compensation rights for acetone and isophorone. Company consortia are conducting all eleven Tier 1 endocrine assays to screen for potential effects on the thyroid, estrogen, and androgen systems. The data were due January 21, 2012, for isophorone, and are due February 7, 2013, for acetone. EPA has determined that the data protection rights as given in Section 3(c)(1)(F) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and FFDCA Section 408(i) apply for all data submitted in support of the EDSP test orders. Importantly, to assist in enforcing these data compensation obligations, registrants of products containing acetone or isophorone must identify the source of these chemicals on their Confidential Statements of Formula (CSF). EPA states that, if a CSF lists a source of isophorone or acetone other than a consortia member, “EPA intends to take appropriate action to ensure that the registrant takes one of the following actions: (i) Changes the source to a consortia member; (ii) submits proof of an offer to pay the consortia to use their data; (iii) submits a commitment to generate the required data; (iv) reformulates; or (v) cancels.” Although EPA does not in the notice explain when or how it will review CSFs and take appropriate action, in its April 15, 2009, Federal Register notice announcing EDSP policies and procedures, EPA stated that it would require new registrants to identify the source of an inert for which EDSP testing has been submitted and would also “on a case-by-case basis… require current registrants to identify the source of a pesticide inert ingredient on which EDSP data have been submitted.” If necessary, EPA intends to issue a data call-in (DCI) or a product-specific test order to ensure one of these actions is taken.

According to EPA, no companies are developing data for the remaining seven inert ingredients. For di-sec-octyl phthalate and toluene, EPA states that it plans to issue new test orders as both chemicals meet the selection criteria for endocrine testing under the SDWA (i.e., the substances may occur in sources of drinking water to which a substantial population may be exposed). EPA plans to wait until the SDWA test orders are issued and it receives the responses before taking further action on these two chemicals. EPA has not yet issued any EDSP test orders for chemicals under its SDWA authority, although most of the substances that are candidates for EPA’s second list of chemicals for EDSP Tier 1 screening are under consideration because EPA believes the substances meet the SDWA criteria.

EPA states that it has no plans to issue further test orders for methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate; instead, it plans to no longer approve their use as inert ingredients in pesticide products. According to EPA, importers and manufacturers of these chemicals all elected to opt out of the pesticide market rather than conduct testing. Under the opt-out provision, these companies were required to cease, within six months of EPA issuing the test order, all sales and distribution of their chemical for use in pesticide formulations. EPA issued the last test orders for these chemicals on January 28, 2010. According to EPA, all sales and distribution of methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate for use in pesticide formulations were to have ceased as of July 28, 2010.

In a separate March 14, 2012, Federal Register notice, EPA proposed to revoke the existing tolerance exemptions for residues of diethyl phthalate and methyl ethyl ketone when used as inert ingredients. Comments on the proposed rule and commitments to develop the required data are due May 14, 2012.

For products already in the marketplace that include methyl ethyl ketone, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, and dimethyl phthalate, EPA intends to take appropriate action to ensure registrants either reformulate or cancel those products, including, if necessary, issuing test orders (product-specific DCIs). EPA reminds registrants that current regulations require them to amend any pesticide product registrations before selling a pesticide product with a composition different from that listed on the approved CSF. Although EPA believes that all sales and distribution should have ceased as of July 28, 2010, EPA states that the effective date for when EPA will no longer approve the use of these inert ingredients in pesticide registration applications will be the same date that EPA has proposed for revoking the tolerance exemptions for methyl ethyl ketone and diethyl phthalate; that is, six months after the date EPA publishes the tolerance revocation final rule. EPA believes its proposed timeline for no longer approving use of these chemicals as inert ingredients gives registrants sufficient time to take appropriate action.