Common use of Development of EPA’s Endocrine Disruptor Screening Program Clause in Contracts

Development of EPA’s Endocrine Disruptor Screening Program. Prior to the passage of the FQPA and SDWA, the Agency initiated several endocrine disruptors investigations including: the development of a special report and effects assessment (Ref. 6); a series of endocrine disruptor methods workshops funded by the World Wildlife Fund, Chemical Manufacturer’s Association, and the Agency (Refs. 1, 3, and 7); and co-sponsorship (with the National Institute of Environmental Health Sciences and Department of the Interior) of an independent critical analysis of the literature on hormonally active agents in the environment by the National Academy of Sciences (Ref. 5). The foregoing activities coincided with the establishment and deliberationsof the Endocrine Disruptor Screening and Testing Advisory Committee (Ref. 2). The complexity of the scientific and regulatory issues surrounding the endocrine disruptor issue led EPA to seek broad expert advice and counsel beyond the Agency. EPA held a public meeting in May of 1996 requesting advice on how to develop a scientifically defensible, pragmatic approach to endocrine disruptor screening and testing. The stakeholder feedback indicated that a broad based multi-sector stakeholder committee should be established under the Federal Advisory Committee Act. Following a second public meeting and analysis of stakeholder interests (Keystone Center Convening Report, see ▇▇▇.▇▇▇.▇▇▇/ scipoly/oscpendo), the Agency chartered the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). ▇▇▇▇▇▇ was charged with providing advice and recommendations to the Agency regarding a strategy for testing chemical substances to determine whether they may have an effect in humans similar to an effect produced by naturally occurring hormones. EDSTAC consisted of 39 representatives from industry, environmental and public health advocacy groups, state government, other Federal agencies, and academic scientists. Over a 2–year period, EDSTAC held eight meetings. To facilitate regional public comment on the process, the meetings were held in different parts of the country (Chicago, San Francisco, New York, Houston, Orlando, Baltimore and Washington) and provided opportunities for public comment. In its final report, EDSTAC (Ref. 2, available at ▇▇▇.▇▇▇.▇▇▇/ scipoly/oscpendo) provided 71 consensus recommendations regarding an endocrine disruptor screening program. Considering the EDSTAC’s diverse membership, EPA found its consensus recommendations compelling and scientifically rigorous. Therefore, EPA closely followed ▇▇▇▇▇▇’s advice and recommendations in developing its Endocrine Disruptor Screening Program (EDSP). EPA’s EDSP is outlined in the August 11, 1998 Federal Register (63 FR 42852) (FRL–6021–3), and further developed as a proposed statement of policy in the December 28, 1998 Federal Register (63 FR 71542) (FRL–6052–9), available at ▇▇▇.▇▇▇.▇▇▇/▇▇▇▇▇▇▇▇/▇▇▇-▇▇▇/▇▇▇▇/ December/Day-28/t34298.htm). The EDSP proposed statement of policy, including public comments, was subsequently reviewed by a joint panel of the FIFRA Scientific Advisory Panel (SAP) and the EPA Science Advisory Board (SAB) in May 1999. Like ▇▇▇▇ et al. (Ref. 3), EDSTAC (Ref. 2) and the NRC (Ref. 5), the SAP/SAB (Ref. 8) final report concluded that a tiered approach relying on a combination of in vivo and in vitro screens for Tier 1 and a set of reasonable. This conclusion was based upon each group’s assessment of the current state-of-the-science on the evaluation of agents impacting the endocrine system. Another consistent conclusion was the need to validate the individual screens and tests in EDSP. The validation and peer review are science-based process steps, which are prerequisite to the final development and approval of test guidelines for regulatory use (Ref. 4). EPA also received public comments on the proposed statement of policy which were considered by the SAP/SAB joint panel review. The Agency will respond to these public comments in a future Federal Register notice and final statement of policy prior to requiring regulatory testing.

Development of EPA’s Endocrine Disruptor Screening Program. Prior to the passage of the FQPA and SDWA, the Agency initiated several endocrine disruptors investigations including: the development of a special report and effects assessment (Ref. 6); a series of endocrine disruptor methods workshops funded by the World Wildlife Fund, Chemical Manufacturer’s Association, and the Agency (Refs. 1, 3, and 7); and co-sponsorship (with the National Institute of Environmental Health Sciences and Department of the Interior) of an independent critical analysis of the literature on hormonally active agents in the environment by the National Academy of Sciences (Ref. 5). The foregoing activities coincided with the establishment and deliberationsof the Endocrine Disruptor Screening and Testing Advisory Committee (Ref. 2). The complexity of the scientific and regulatory issues surrounding the endocrine disruptor issue led EPA to seek broad expert advice and counsel beyond the Agency. EPA held a public meeting in May of 1996 requesting advice on how to develop a scientifically defensible, pragmatic approach to endocrine disruptor screening and testing. The stakeholder feedback indicated that a broad based multi-sector stakeholder committee should be established under the Federal Advisory Committee Act. Following a second public meeting and analysis of stakeholder interests (Keystone Center Convening Report, see ▇▇▇.▇▇▇.▇▇▇/ scipoly/oscpendo), the Agency chartered the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC). ▇▇▇▇▇▇ EDSTAC was charged with providing advice and recommendations to the Agency regarding a strategy for testing chemical substances to determine whether they may have an effect in humans similar to an effect produced by naturally occurring hormones. EDSTAC consisted of 39 representatives from industry, environmental and public health advocacy groups, state government, other Federal agencies, and academic scientists. Over a 2–year period, EDSTAC held eight meetings. To facilitate regional public comment on the process, the meetings were held in different parts of the country (Chicago, San Francisco, New York, Houston, Orlando, Baltimore and Washington) and provided opportunities for public comment. In its final report, EDSTAC (Ref. 2, available at ▇▇▇.▇▇▇.▇▇▇/ scipoly/oscpendo) provided 71 consensus recommendations regarding an endocrine disruptor screening program. Considering the EDSTAC’s diverse membership, EPA found its consensus recommendations compelling and scientifically rigorous. Therefore, EPA closely followed ▇▇▇▇▇▇EDSTAC’s advice and recommendations in developing its Endocrine Disruptor Screening Program (EDSP). EPA’s EDSP is outlined in the August 11, 1998 Federal Register (63 FR 42852) (FRL–6021–3), and further developed as a proposed statement of policy in the December 28, 1998 Federal Register (63 FR 71542) (FRL–6052–9), available at ▇▇▇.▇▇▇.▇▇▇/▇▇▇▇▇▇▇▇/▇▇▇-▇▇▇/▇▇▇▇/ December/Day-28/t34298.htm). The EDSP proposed statement of policy, including public comments, was subsequently reviewed by a joint panel of the FIFRA Scientific Advisory Panel (SAP) and the EPA Science Advisory Board (SAB) in May 1999. Like ▇▇▇▇ et al. (Ref. 3), EDSTAC (Ref. 2) and the NRC (Ref. 5), the SAP/SAB (Ref. 8) final report concluded that a tiered approach relying on a combination of in vivo and in vitro screens for Tier 1 and a set of reasonable. This conclusion was based upon each group’s assessment of the current state-of-the-science on the evaluation of agents impacting the endocrine system. Another consistent conclusion was the need to validate the individual screens and tests in EDSP. The validation and peer review are science-based process steps, which are prerequisite to the final development and approval of test guidelines for regulatory use (Ref. 4). EPA also received public comments on the proposed statement of policy which were considered by the SAP/SAB joint panel review. The Agency will respond to these public comments in a future Federal Register notice and final statement of policy prior to requiring regulatory testing.