[Pharmwaste] FDA adding reseacher to guide research/regulation of
drugs w/ Estrogenic, Androgenic, or Thyroid Activity
EGottlieb at cityofithaca.org
Tue Sep 1 14:28:33 EDT 2015
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. To comply, FDA implements 21 CFR Part 25, which includes a requirement for an environmental assessment (EA) if “extraordinary circumstances” indicate that the specific proposed action may significantly affect the quality of the human environment.
The new EA draft guidence, Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity, informs drug applicants that recent research indicates that some drugs with hormonal activity in the environment may exhibit “extraordinary circumstances” and that the Agency may require additional ecotoxicity testing for applications submitted for drugs with hormonal activity. In addition, antimicrobial, additivity/synergism, nanotechnology, and other properties have been implicated for possible adverse environment effects, as well as human effects through environmental pathways. Also, other Centers (e.g., CVM), agencies (e.g., EPA), and regions (e.g., EU) have begun addressing these issues through research, guidance, and regulatory development. The EA Staff requires support for research and implementation to address these issues.
Rhetorically, I wonder how big the FDA research staff is that they are only adding one temporary position to help cover the huge range of tasks spelled out in the job announcement (link above)? Who would take on such a daunting task, knowing they have to do it in only one year? And, as a consultant, they have to provide their own health insurance.
Chair, Coalition for Safe Medication Disposal
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY 14850
fax: (607) 273-8433
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