NTP Director Turns Spotlight on Endocrine Disruptors

March 20, 2012

By Ricardo Carvajal
Linda Birnbaum, Director of the National Institute of Environmental Health Sciences and the National Toxicology Program, published an editorial discussing the most recent evidence that certain environmental chemicals, including suspected endocrine disruptors such as BPA, “can have effects that would not necessarily be predicted from their effects at high doses” – referred to as the “low dose hypothesis.”  As the editorial puts it, “the question is no longer whether nonmonotonic dose responses are ‘real’ and occur frequently enough to be a concern; clearly these are common phenomena with well-understood mechanisms.”  The upshot is that “chemicals with hormonal activity can have effects at external doses that are often considered safe by the regulatory community.”

With regard to BPA specifically, FDA is expected to announce later this month whether the agency will act to amend or rescind BPA’s approved food additive uses – a move compelled in part by a lawsuit filed by the Natural Resources Defense Council.  It will be interesting to see whether evidence of nonmonotonic dose responses plays any part in FDA’s decision.

REMINDER: HP&M is hosting FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies, a webinar on March 21, 2012, 12:30 – 2:00 p.m. ET.  Click here to register.