STATS ARTICLES 2011
The NRDC's Attack on Science: Will California Cave to Political Pressure in Regulating Bisphenol A (BPA)?
Jon Entine, July 8, 2011
What will California regulators do in choosing between science and politics when it comes to regulating chemicals in the crosshairs of advocacy groups, such as the ubiquitous plastic additive bisphenol A (BPA)?
When you can’t win on the evidence, invoke the law and pray the web mob will carry the water for you. Unfortunately, that has been the strategy of activists on the left and right when science policy is in play.
The US Chamber of Commerce has used this tactic to try to thwart regulatory responses to climate change. It’s become a mantra of mostly liberal anti-vaccine crusaders. And it’s emerged as the calling card of factions in the environmental movement that are bullying legislatures into banning the ubiquitous plastic additive bisphenol A. California is the latest battleground.
California, with the world’s 8th largest economy, is the Big Magilla when it comes to regulation. It often serves as a vanguard for environmental standards, smart and stupid alike. Under the state’s Proposition 65, the “The Safe Drinking Water and Toxic Enforcement Act of 1986”, chemicals officially listed by California as causing cancer, birth defects or other reproductive harm can be restricted and mandatory labeling can be required. That makes sense in theory but challenges to science can arise in its implementation.
Up until now, the state depended on its toxic investigatory committee to make that determination, and it has consistently determined BPA is safe. But because of a legal action from the National Resources Defense Council, a DC-based activist group, the state may be forced to list as dangerous a chemical that its own scientists believe does not pose a public danger. The mid-July meeting of California’s Office of Environmental Health Hazard Assessment (OEHHA) will provide some insight into just how far politics and legal maneuvering are infecting what’s supposed to be a science-driven process.
The chemical in the crosshairs, known as BPA, is used in electronics, thermal paper, car dashboards, eyeglass lenses and polycarbonate plastics, from microwavable containers to infant sippy cup, and added to epoxy resins to create dental sealants and line metal cans to prevent spoilage and botulism. It’s a multi-billion dollar industry. For many of those uses there are no cost-effective alternatives.
Over the past few years, the dominant narrative among campaigning organizations and select media is that BPA is dangerous to infants and pregnant women because it alters development. Its detractors call it an "endocrine disruptor." BPA does subtly alter the way hormones work. But so do phytoestrogens, the natural chemicals in soy, nuts, wheat, berries and other foods, to no serious affect. Scientists call this endocrine mediation but BPA opponents coined the term “endocrine disruptor” as a form of political labeling—much like “death tax” or “pro-life”—and it’s now used by activists to catalyze public opposition.
Despite what alarmist headlines and Internet chatter might suggest, no panel of regulatory scientists in the world recommends restricting BPA based on evidence of harm. The World Health Organization, the European Union risk assessment board, the US Food and Drug Administration and Health Canada, Japan, New Zealand and Australia have all rejected restrictions on BPA based on the science.
Regulators universally contend that the results from 200 or so studies cited by activists as “proof” of potential harm —almost all university-based studies—are contradictory and too small scale to be reliable. Scientists call them “exploratory” or “hypothesis driven” research, which focus on targeted questions designed to challenge existing paradigms. They are an important part of the research chain but in and of themselves are of limited value—they are not the kind of robust studies or meta-research that regulators utilize to establish “weight of evidence” or to do cost/benefit analysis to determine if a chemical should be restricted in the market place.
In January 2010, the FDA issued its second analysis of BPA in two years. Surprising activists but not scientists, the FDA rejected new restrictions. BPA "is not proven to harm children or adults" and the most reliable studies to date support "the safety of current low levels of human exposure to BPA," the FDA concluded.
It based its decision on a 2008 report by the National Toxicology Program that found BPA posed “negligible” or “minimal” concern for effects on the mammary gland and early puberty for fetuses, infants or pregnant women or for its impact on pregnant women and their offspring. The NTP concluded there was "some concern" for effects on the “brain, behavior and prostate glands in fetuses, infants, and children.” According to the NTP, “some concern” means “more research is needed to better understand their implications to for human health,” but regulators should not act precipitously on preliminary animal data from exploratory studies.
But in the case of BPA, precautionary politics has sometimes trumped science. Health Canada’s political arm and the Danish and French parliaments rejected their own scientists’ recommendations and imposed precautionary bans, acknowledging such actions were based on public fears, as the “[s]cience tells us that exposure levels are below those that could cause health effects”. Numerous states in the US have followed suit. But California has so far resisted. Last year, the state’s Senate rejected a House proposal to ban BPA in baby bottles and other feeding products for children. But the issue lives on despite legislative and regulatory rebukes.
Shifting Tactics in California
Recognizing that they might not win legislative approval, activists focused on trying to ban the chemical by forcing the state’s hand under Prop 65. But two years ago, California's Development and Reproductive Toxicant Identification Committee, consisting of a panel of seven top physicians, voted unanimously that BPA should not be classified as a dangerous toxicant because there was no persuasive evidence of harm to humans.
That did not sit well with the NRDC, which filed a petition to the implementing agency, OEHHA. The NRDC demanded that California ignore the DART-IC recommendations and impose restrictions regardless. The NRDC’s rationale? It cited the NTP report—the one used by the FDA in 2010 to reject imposing any new restrictions as the reason for restricting use in California.
In bringing its petition, the NRDC cherry-picked the NTP report, misleadingly stating that it “concludes that the chemical causes reproductive toxicity” in humans. It teased out studies of laboratory rodents which show that exposure to a “high level of bisphenol A during pregnancy and/or lactation can reduce survival, birth weight and growth of offspring early in life, and delay the onset of puberty in males and females.”
What the NRDC left out is that the highlighted studies focused on rats, which were continuously exposed to BPA at levels 100 to 10,000 times higher than what humans are exposed to. After weighing the evidence for humans, the NTP had concluded it had “negligible concern that exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects, or reduced weight and growth in their offspring”.
But the NTP’s conclusions, presented in context, may not mean much to the OEHHA, as Prop 65 has a loophole as big as the hole in NRDC’s scientific credibility. The act has what’s called “sufficiency criteria” that mandate listing if any authoritative body “formally identifies the chemical as causing reproductive toxicity”—even if the studies focused on rodents and the conclusions do not transfer to humans. The NRDC is lobbying to convict BPA on a technicality or a loosey-goosey interpretation of the sufficiency clause.
Scientists push back
The NRDC tries to suggest that those opposing restrictions are industry dupes willing to sacrifice pregnant women for profit. Industry is opposed as the cost to companies and ultimately to consumers in restricting BPA could be in the billions of dollars. But the key opposition to BPA restrictions is now coming from scientists in the field.
At first glance, a ban that supposedly would protect infants might sound like an appealing idea—taking reasonable precautions. But it’s questionable public policy that would actually hurt children. Regulators, who rely on science rather than public opinion, must weigh the potential consequences of switching to other products with less tested chemicals just to placate public fears. That would be akin to rolling the toxic dice. Moving to glass bottles could also result in direct injuries from breakage.
As David Coggon, Chairman of the Committee on Toxicity in the precautionary obsessed UK, said recently to the UK Food Safety Authority’s spring issue of Bite magazine, “BPA has estrogenic properties” but that does not imply a health risk. “As with all chemicals, risk depends on the extent to which a person is exposed. Thus, drinking a whole bottle of whisky at one sitting would have serious toxic effects, whereas no harm would be expected from the alcohol in a spoonful of sherry trifle. … The ban on BPA in baby-feed bottles is not based on scientific evidence of harm or even on a strong suspicion that it could be harmful.”
Independent scientists and regulators at the FDA take an equally dim view of activist demands. During the January 2010 news conference announcing the FDA’s decision opposing a ban, Joshua Sharfstein, M.D., then the agency's principal deputy commissioner, minced no words. "The FDA does support the use of bottles with BPA because the benefit of nutrition outweighs the potential risk of BPA,” he said. “If we thought it was unsafe, we would be taking strong regulatory action." The NRDC subsequently sued the FDA for allegedly failing to take timely action to ban BPA. The courts rejected the NRDC lawsuit in early June but that has not prevented the group from continuing its anti-BPA actions.
In science, it often takes time before old paradigms are abandoned, and that seems to be the case with activists who continue to cling to the narrative that BPA is a harmful endocrine disruptor. Over the past two years the science consensus has moved sharply away from the speculative hypothesis. The FDA has been joined by the European Food Safety Authority in summer 2010, a joint UN Food and Agriculture Organization/WHO expert panel on BPA in November 2010, and a special Advisory Committee of the German Society of Toxicology last spring in concluding that the collective evidence from thousands of studies demonstrates that BPA does not pose serious neurological dangers or cause cancer in humans, and has not been established as an “endocrine disruptor.” Other studies are in the works, but the new consensus on BPA is turning from yellow to green.
FDA/CDC study challenges activist claims
One by one the central contentions promoted by anti-BPA campaigners have fallen in the face of more robust studies. The latest revelation came just last month. It’s been widely reported to much alarm by campaigners that BPA shows up in the urine of more than 90 percent of subjects sampled. Are such levels dangerous, as the NRDC asserts? “Biomonitoring studies clearly show BPA is present in the human body at levels that are concerning for health impacts,” asserts NRDC senior scientist Sarah Janssen. “Therefore, the fetus is being exposed to a toxic form of BPA during extremely vulnerable periods of development.” Such claims have been widely displayed on activist web sites.
But the latest research, a state-of-the-art study co-sponsored by the FDA and the Centers for Disease Control and Prevention and published in Toxicological Sciences in June, directly contradict the NRDC’s blithe and incendiary claim. Rather than studying animals, this research involved human volunteers who were exposed to high levels of BPA by eating canned food and beverages from plastic bottles. Justin Teeguarden, a senior research scientist with the Pacific Northwest National Laboratory, and his team of government-funded researchers conclude that human exposure to BPA is extremely low and it’s highly unlikely that the chemical could cause health effects in humans as it is efficiently metabolized and excreted from the body.
Richard Sharpe, head of the Centre for Reproductive Biology at the Medical Research Institute in Edinburgh interpreted the results for a colleague, Trevor Butterworth, an editor at large at STATS and a Medialand columnist at Forbes.com. I quote it extensively, as it speaks to the shoddy science deployed by activists that has driven this debate. Sharpe calls the study “majestically scientific and cautious”:
Beautifully designed and executed and with clearcut results (that fit in well with the majority of published data)…. [T]he general population [is] essentially exposed internally (i.e. our working tissues and cells) to minute levels of BPA after we eat foods that are known to be the main source of our BPA exposure. Indeed the levels are so low that often they cannot be measured. …
It means that the majority of effects observed in animal studies are probably not relevant to humans because they involved much higher BPA exposures. … [T]he authors take one example from the literature of a high quality animal study … in which BPA exposure was measured and show that even in this scenario, one would have to conclude that such effects would not occur in humans unless we are 100 to 10,000 times more sensitive to BPA effects than are rats. [T]he take-home message is: BPA is highly unlikely to induce any effects in humans because we simply are not normally exposed to anywhere near enough BPA to cause such effects.…
As Sharpe notes, studies are continuing on possible other effects, but nothing definitive yet presents itself. His comments are particularly noteworthy as he has no industry ties and is a recognized pioneer on the effects on endocrine mediation. He was also an early believer in the “endocrine disruptor” thesis.
"Just apply common sense,” Sharpe commented recently. “If several studies using the human-relevant route of exposure show no effect but a small preliminary study does show effects, which would you believe? … The overwhelming scientific evidence says that bisphenol A is not a risk to human health."
A growing consensus of scientists are convinced that the “endocrine disruptor” hypothesis is dead, and precious research funds should be directed elsewhere. When or if dedicated anti-BPA campaigners yield to the emerging science remains to be seen. Let’s hope the OEHHA has the wisdom and courage to base its decision on science rather than on a narrow interpretation of Proposition 65.
Jon Entine, senior fellow at STATS and the Center for Health and Risk Communication at George Mason University, and director of the Genetic Literacy Project, is author of “Scared to Death: How Chemophobia Threatens Public Health.”