USEPA Endocrine Disruptor Screening Program (EDSP)

In case you may not have noticed, on October 21, 2009 the USEPA initiated the Endocrine Disruptor Screening Program (EDSP), in particular, the USEPA implemented the Tier 1 screening portion of the EDSP under section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA). On October 21, 2009, the USEPA identified 67 chemical compounds that are subject to a two-tier testing approach and issued Tier 1 screening test orders to manufacturers, users, and importers or testers of pesticide/agricultural chemicals. 

 

Under section 408(p)(1) of the FFCDA, the USEPA is required “to develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as EPA may designate.” Section 408(p)(3) specifically requires that the USEPA “shall provide for the testing of all pesticide chemicals.” As summarized in the Federal Register (Volume 74, No. 202, October 21, 2009, pages 54422 through 54428), the EDSP applies to the following potentially affected entities:

 

·     Chemical manufacturers, importers and processors (NAICS code 325).

·     Pesticide, fertilizer, and other agricultural chemical manufacturing (NAICS code 3253).

·     Scientific research and development services (NAICS code 5417), e.g., individuals who conduct testing of chemical substances for endocrine effects.

 

The first group of 67 chemicals to be screened consists of chemicals that section 408(p) of the FFDCA requires to be screened, i.e., “pesticide active ingredients and chemicals used as pesticide inert ingredients.” Each of the 67 chemicals and the order issuance dates are provided in the October 21, 2009 Federal Register Notice. Each Tier 1 test order recipient must respond to the USEPA within two years of issuance, and recipients have the option to cite or submit existing data in lieu of developing new bioassay test data. Existing data can include data that have been developed using USEPA approved bioassays (as cited in the Tier 1 test order) or use of other scientifically relevant information (OSRI). USEPA has provided guidance on the use of OSRI in a paper entitled “EPA’s Approach for Considering Other Scientifically Relevant Information (OSRI) under the EDSP” (see docket number EPA-HQ-OPPT-2007-1080-0032 at www.regulations.gov). It should also be noted that USEPA provides a procedure by which members of the public may also submit “scientifically relevant information related to one of the chemical-specific orders” to the USEPA in the October 21, 2009 Federal Register Notice. 

 

Finally, it should be noted that Tier 1 test orders may be issued for approximately 100 additional chemicals later this year. In addition to this concern, members of the regulated community have expressed concerns regarding what some of the options for responding to the USEPA actually mean, whether the Tier 1 screening bioassays are scientifically defensible, and what are the implications (e.g., public perception) of having certain chemicals identified as Tier 1 screening test substances, even if a chemical is subsequently determined not to be an endocrine disruptor.

 

To obtain additional information regarding the EDSP, the USEPA has established a docket under docket ID number EPA-HQ-QPP-2009-0634, which can be accessed through www.regulations.gov. The October 21, 2009 Federal Register Notice can be accessed electronically through the USEPA Internet under the “Federal Register” listings at www.epa.gov/fedrgstr. 

 

This article was authored by Greg Tieman, Acacia Environmental Group LLC. For more information on the author see here.