Is It Safe? by Sarah A. Vogel

Author:Sarah A. Vogel
Language: eng
Format: epub
ISBN: 9780520954205
Publisher: University of California Press

DEFINING “LOW-DOSE”

The lack of replication of vom Saal’s work by industry studies and the very small body of research on BPA’s low-dose effects helped the FDA easily reject calls for a review of the chemical’s safety. “Until you can replicate something, you can’t interpret its significance,” the director of the FDA’s Division of Product Policy, George Pauli, stated in 1999. “Our conclusion is we should go with the track record. We have evaluated [food contact uses of BPA] in a thorough manner, and concluded its use is safe. We haven’t seen anything that would persuade us to change that.”37

While the FDA upheld the industry’s position that there was no significant evidence indicating a need to reevaluate BPA’s safety, the EPA, under its mandate to develop a testing and screening program for endocrine disruptors, kept the low-dose issue alive. In 2000, faced with profound uncertainty as to how to incorporate low doses into endocrine-disruption testing, the EPA requested that the NTP review the matter. In early 2000, the NTP announced its plan for a three-day workshop, organized by Ronald Melnick, director of Special Programs, to evaluate low-dose research on estrogenic compounds including BPA, DES, ethinylestradiol (estrogen used in birth control), nonylphenol (an industrial compound used in pesticides and plastics and found in drinking water), octylphenol, genistein (a derivative of soy), methoxychlor (a pesticide), estradiol (a natural estrogen), and vinclozolin (a pesticide).38

Having spent twenty years at the NTP, Melnick maintained an astute sense of how power, personality, bias, and influence could inform the outcomes of expert panels, and how the initial framing of a scientific question structured process and informed the results.39 While aware of how the scientific process could be politically manipulated, he held firmly to a commitment to rigorous scientific research and the need to manage distortion, bias, and conflict.40 Melnick effectively applied this insight to the design of the low-dose review process, which he recognized was already a highly contentious topic. Working with an organizing committee composed predominantly of scientists from the NTP and the EPA, as well as Lynn Goldman, who chaired the EDSTAC process while at the EPA, Melnick created a process that sought to maximize expert knowledge and minimize personal or political influence. For instance, the organizers invited key researchers whose data on BPA were at the center of the scientific controversy to present their research but not to sit on the workshop’s decision-making panel. These included vom Saal; Ashby from AstraZen-eca; Retha Newbold, who had twenty-five years of experience working with DES at the National Institute of Environmental Health Sciences; Rochelle Tyl, a researcher from Research Triangle Institute, a private laboratory, who conducted several large-scale studies on BPA under industry contracts; and several industry scientists, including Robert Chapin from DuPont Haskell Lab, John Waechter of Dow Chemical Company (a coauthor of several of the plastics industry–sponsored BPA studies), and Frank Welsh from the Chemical Industry Institute of Toxicology. The BPA panel members responsible for evaluating and interpreting the implications of the research included university researchers and government officials from the United States, Japan, and Canada.

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