Testing Orders for Endocrine Effects of Pesticide Inerts: EPA is Batting only 222

Date: Aug 17, 2010

As of August 5, 2010, no manufacturers or importers of methyl ethyl ketone, toluene, butyl benzyl phthalate, dibutyl phthalate, diethyl phthalate, dimethyl phthalate, or di-sec-octyl phthalate have volunteered to sponsor these inert pesticide ingredients under the Environmental Protection Agency's (EPA) Endocrine Disruptor Screening Program (EDSP).[1] Suppliers of these inert ingredients who received a Testing Order pursuant to the EDSP must subject all future sales to contract restrictions prohibiting the use of such inerts in pesticides (the last pesticidal sale date for toluene is August 28, 2010). Registrants of pesticide products containing these substances are free to continue producing their pesticide products, to the extent they have supplies on hand or are otherwise able to obtain these substances, notwithstanding the contract restrictions. EPA's zeal to force expensive testing on pesticide inert suppliers appears to have backfired as manufacturers commit to sponsor only 2 of 9 chemicals, a batting average of 222. As a practical matter, registrants will take steps to ensure their ability to continue to make pesticides by reformulating with "EDSP-free" components. Once all registrants have approvals for formulations that are free of EDSP components, there will be no incentive for anyone to generate the data EPA is seeking.

EPA created the EDSP pursuant to its authority under Section 408(p)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).[2] The purpose of the EDSP is to screen active and inert pesticide ingredients suspected to have an effect in humans similar to that of natural endocrine hormones, such as estrogen. The intent is to condition continued use of these chemicals in pesticide formulations on a commitment to submit data to EPA from a battery of in vitro and in vivo screening assays. According to EPA, the projected cost for conducting the screening assays for a single chemical is $404,315.[3] However, this is likely to be a significant underestimation because, among other shortcomings, EPA relied on a 2003 cost survey in preparing this estimate.[4]

Pursuant to Section 408(p)(5) of the FD&C Act, EPA issued individual Testing Orders to current pesticide inert ingredient manufacturers and importers, which required an initial response within 90 days. In its response, the inert supplier must indicate that it will undertake one of the following actions:

  • Individually Generate Data;
  • Submit or Cite Existing Data;
  • Form or Offer to Join a Task Force;
  • Claim not to be subject to the Order;
  • Discontinue the Manufacture or Import of the Chemical;
  • Stop Sales into the Pesticide Market;
  • Demonstrate the chemical is an endocrine disruptor and screening or testing is unnecessary; or
  • Claim the "chemical was used by EPA as a ‘positive control' to validate one or more of the screening assays."

If Order recipients choose not to provide the requested data, they may continue to market the inert substances for non-pesticidal use, but they must discontinue pesticidal sales within 6 months of the date of the Testing Order. Additionally, they must include in all contracts for the sale or distribution of the inert ingredient a provision proscribing the purchaser from using the substance to formulate a pesticide product. A manufacturer or importer who fails to comply with any of the requirements enumerated in a Testing Order is liable for penalties of up to $37,500 per violation, where each day of violation constitutes a separate violation.[5]

Despite several public comments pointing out that there would be no reason for inert ingredient manufacturers to invest in expensive testing since use in pesticides typically constitutes a small portion of total production,[6] EPA went forward with the same Testing Orders for inerts as it did for actives. In 2009, EPA announced that the first set of Testing Orders would apply to 67 chemicals, 58 active and 9 High Production Volume (HPV) inert pesticide ingredients.[7] EPA issued Testing Orders to manufacturers, processors and importers of several phthalates and methyl ethyl ketone in January 2010 (February 2010 for toluene). Any company responding that it would discontinue the sale of these chemicals for pesticide use was required to discontinue such sales in July 2010 (August 28, 2010 for toluene). Thus, manufacturers and importers of the phthalates and methyl ethyl ketone may no longer knowingly sell these substances for use in pesticides. EPA's failure to anticipate that no manufacturers would commit to support testing has put EPA in the position where market disruptions and urgent reformulation amendments are guaranteed, and EPA lost much of its leverage to ensure that the desired data are generated.

Nevertheless, EPA still wants data for these ingredients. EPA's Policies and Procedures for Initial Screening included a poorly developed contingency plan should no inert manufacturers or importers agree to conduct testing. Plan B is to issue a Federal Register notice "informing registrants that the pesticide inert ingredient will no longer be available for use in formulating pesticide products unless someone commits to generate the required data" within 6 months of publication.[8] It is not clear who EPA intends will generate the data, given that no inert suppliers have agreed to do so and, therefore, have ceased supplying the substances for pesticide use. Once all products have been reformulated so that these substances no longer appear in registered pesticide products, the substances will no longer meet the definition of pesticide chemicals.

Indeed, it is not clear that EPA can issue Testing Orders to registrants of products that still contain the listed components. Section 408(p)(5)(A) of the FD&C Act authorizes EPA to issue orders "to a registrant of a substance for which testing is required . . . or to a person who manufactures or imports a substance for which testing is required . . . ." Inert ingredients are listed with EPA by manufacturers and importers, but they are not registered as such, and in any event, inert ingredients are not registered by the owners of finished product registrations.

EPA's only recourse to get the desired data may be to conduct the testing itself or inspire voluntary efforts for the sake of documenting the value of endocrine screening tests.

For more information on the Endocrine Disruptor Screening Program and inert ingredients, please contact Adrienne M. Timmel (timmel@khlaw.com).

[1] Manufactures and importers of acetone and isophorone volunteered to generate data. See Status of EDSP Orders/DCIs as of Thursday, August 5, 2010, available at http://www.epa.gov/endo/pubs/edsp_orders_status_080510.pdf.

[2] 21 U.S.C. § 346a(p)(1).

[3] See Calculations for Paperwork Burden and Costs for Data Generation Activities (April 3, 2009), available at http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480954380

[4] See Response to Comments on the Public Review Draft of the Information Collection Request (ICR) entitled: "Tier 1 Screening of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)" (April 10, 2009), available at http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480954383

[5] See 21 U.S.C. § 346a(p)(5)(D) (invoking the penalty provisions of Section 16 of the Toxic Substances Control Act, codified at 15 U.S.C. § 2615). See also, EPA Civil Monetary Penalty Inflation Adjustment Rule, 74 Fed. Reg. 626, 627 (Jan. 7, 2009) (codified at 40 C.F.R. § 19.4).

[6] See EPA Response to Comments on the DRAFT Endocrine Disruptor Screening Program (EDSP): Policies & Procedures for Initial Screening and Testing (March 26, 2009), available at http://www.epa.gov/endo/pubs/pandp_r2c_041509.pdf (henceforth "EPA Response to Comments on the Draft Policy and Procedures").

[7] 21 U.S.C. § 346a(p); Final List of Initial Pesticide Active Ingredients and Pesticide Inert Ingredients to be Screened Under the Federal Food, Drug, and Cosmetic Act, 74 Fed. Reg. 17,579, 17,583-17,585 (April 15, 2009).

[8] EPA Response to Comments on the Draft EDSP Policy and Procedures, at 13.