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B&C® Consortia Management, L.L.C. (BCCM) is assisting companies with forming testing consortia to fulfill regulatory requirements under the U.S. Environmental Protection Agency's (EPA) Endocrine Disruptor Screening Program (EDSP).
On June 14, 2013, EPA issued the final second list of chemicals and substances for Tier 1 screening under the EDSP. Our memorandum regarding this development is provided below. EPA has indicated that it will issue test orders for the Group 2 chemicals in batches, with the first batch to be issued as early as September 2013.
The EDSP has an extremely short deadline, with only two years allowed for completion of the required tests, some of which take as long as 15 months. Companies that manufacture or import chemicals on the Group 2 list are urged to be proactive and work to establish a testing consortium NOW -- before a test order is issued. In addition to addressing the administrative organization issues prior to issuance of a test order, consortium members will have time to identify potential scientifically relevant information to submit to EPA in lieu of testing. It will also allow members to identify potential testing facilities, and even begin some testing -- if so desired -- before the order is issued. This permits companies to ease the financial burden of intense testing costs over the short two-year window provided by the EDSP.
BCCM can assist in identification and outreach to potential consortium members. Once the consortium is established, BCCM will work with the members to set up a budget, establish cost sharing agreements, outline testing schedules, and request bids. BCCM will manage all the administrative and financial issues associated with the consortium, including meetings/conference calls, bank accounts, tax accounting, and more. If desired by consortium members, BCCM can also offer toxicological expertise from experienced scientists with respect to placement and monitoring of the testing programs. This option may be of interest to companies that lack staff resources or expertise in toxicology testing. Complete information on BCCM staff and services is available at www.bc-cm.com.
In addition to the services offered by BCCM, because of its affiliation with Bergeson & Campbell, P.C. (B&C), BCCM has access to highly-trained, sophisticated attorneys and other professionals with significant expertise in regulatory law, data compensation, and EPA policy guidance. Test programs such as EDSP often present substantial risk information reporting questions, the answers to which experienced counsel may be needed. B&C is one of the few law firms in the country with a comprehensive domestic and international pesticide and industrial chemical practice group.
For more information or to discuss joining or forming an EDSP testing consortium, please contact Kathleen M. Roberts.
From Bergeson & Campbell, P.C.'s June 14, 2013, Clients and Friends Memorandum:
EPA Publishes Final EDSP Policies And Procedures And Final Second List Of Chemicals And Substances For Tier 1 Screening: On June 14, 2013, EPA published a Federal Register notice describing its final policies and procedures for requiring Tier 1 screening under the Endocrine Disruptor Screening Program (EDSP) of chemicals for which EPA may issue EDSP test orders pursuant to Section 1457 of the Safe Drinking Water Act (SDWA) and Section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA). 78 Fed. Reg. 35909. FFDCA Section 408(p) directed EPA to develop a chemical screening program using appropriate validated test systems and other scientifically relevant information (OSRI) to determine whether certain chemicals may have hormonal effects. These final policies and procedures supplement the EDSP policies and procedures that were published in the Federal Register on April 15, 2009. According to EPA, the 2009 policies and procedures were originally developed for screening pesticide chemicals and relied, in part, on a regulatory context that is specific to pesticide chemicals. EPA states that "the presumptions applicable in that context are not necessarily applicable to this larger universe of chemicals," which include chemicals used in pharmaceuticals and personal-care products, among others. In a separate Federal Register notice, also published June 14, 2013, EPA announced the final second list of 109 chemicals identified for Tier 1 screening under the EDSP. 78 Fed. Reg. 35922. The EDSP consists of a two-tiered approach to screen and test chemicals for potential endocrine disrupting effects. EPA states that the purpose of Tier 1 screening is to identify substances having the potential to interact with the endocrine system. Substances that have the potential to interact with estrogen, androgen or thyroid systems may proceed to Tier 2, which is designed to identify any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that endocrine effect. EPA notes that the second list "should not be construed as a list of known or likely endocrine disruptors." More information regarding the EDSP is available online.