Lecture 9_BisPhenol A Case Study_Sept 24

Lecture 9_BisPhenol A Case Study_Sept 24 - Bisphenol-A Case...

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Bisphenol-A Case Study in Risk Assessment Megan R. Schwarzman, MD, MPH PH 150B – September 24, 2009 University of California, Berkeley School of Public Health Center for Occupational & Environmental Health
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BPA Case Study Risk assessment overview Bisphenol-A (BPA) basics: exposure and effects Challenges for BPA risk assessment 1. Hazard identification: incorporating new science; testing for the right endpoint; association vs. causation 2. Dose-Response: low dose effects; extrapolation 3. Exposure Assessment: variability of exposure 4. Risk Characterization: association vs. causation; vulnerable populations and life stages; industry influence
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Bisphenol-A Timeline 1891 1891: bisphenol-A first synthesized 1930 1930: recognized as a synthetic estrogen 1940’s 1940’s: used to manufacture hard plastics 1988 1988: U.S. EPA sets “safe” exposure level 1997-1999 1997-1999: BPA found in baby bottles and canned formula; first studies show low-dose effects 2003-2006 2003-2006: NTP reviews evidence of BPA toxicity February, 2007 February, 2007: Congress launches conflict-of-interest investigation industry contractor doing NTP review April-June, 2007 April-June, 2007: NTP fires contractor; report unchanged; experts identify 297 flaws in report; January, 2008 January, 2008: Congress orders FDA review basis for “safety” of BPA in infant formula cans; FDA reveals reliance on 2 industry-funded studies April, 2008 April, 2008: Wal-Mart pulls BPA bottles off shelves September, 2008: September, 2008: NTP final report expresses "some concern" for BPA's effects on fetal development October, 2008 October, 2008: Canada restricts BPA; FDA starts re-assessing safety 2009: 2009: States propose BPA bans (CA, CT, MN, NY); Endocrine Society Statement
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Determinants of Risk Risk = Risk = f ( f ( hazard x exposure) hazard x exposure) Hazard: Toxicological properties Dose Vulnerable windows of development Exposure: Environmental medium Time course (chronic vs. acute) Potency Timing of exposure
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Used by Environmental Agencies Risk Assessment Step Outcome 1. Hazard Identification Level of evidence for disease endpoint (e.g. “likely human carcinogen”) 2. Dose-Response Assessment Disease incidence relative to exposure level; LOAEL/NOAEL 3. Exposure Assessment Human exposure estimates (e.g. mg/kg/day from food/air/skin)
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Lecture 9_BisPhenol A Case Study_Sept 24 - Bisphenol-A Case...

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