Development of EPA’s Endocrine Disruptor Screening Program Clause Samples

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 ...

Related to Development of EPA’s Endocrine Disruptor Screening Program

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in ▇▇▇▇▇, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in ▇▇▇▇ rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

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