When activists don’t get their way at the U.S. Food and Drug Administration.
Certain political activists and the peddlers of pseudo-science who support them have been in high dudgeon ever since the U.S. Food and Drug Administration issued its March 30 denial of a petition to ban bisphenol A (BPA) from food contact applications. BPA, a ubiquitous chemical, has been used safely for more than 50 years in polycarbonate plastics and in the lining of canned food to prevent bacterial contamination.
Research findings by federal government laboratory scientists, the results of which were announced last year, should have put the scare-mongering over BPA to rest. A human exposure study found that because of the way BPA is processed in the body, it would be virtually impossible for it to cause health effects in adults, children, or even fetuses. But the response from those who did not prevail in the FDA decision was sadly predictable: They smeared the agency and its scientific reviewers.
After more than two months of trashing the FDA, activists have taken a new tack to try to discredit the agency and its March decision. The argument, advanced by long-time BPA critic Frederick vom Saal and collaborator Patricia Hunt, claims there is a “Catch-22” imposed by the FDA on university researchers.
This disconnect is supposedly that the FDA rejected the conclusions of many experiments because researchers did not use enough laboratory animals due to federal restrictions on how many such animals may be used in experiments.
Vom Saal and his acolytes believe this to be the Silver Bullet that discredits the FDA’s decision. But vom Saal, notorious for his ridiculous claim that feeding an infant with a shatterproof baby bottle was akin to giving the child a birth control pill, contradicts his own argument.
While denouncing the FDA decision because of its protocols involving lab animals (in the same commentary appearing in two different publications on June 8 and June 10) , he states in both articles that “The FDA should know that the strength of conclusions that can be drawn from data is not directly dependent on the number of animals used.”
On this count, vom Saal is correct. The FDA rejected arguments to ban BPA because none of the studies purporting to show harm conducted by vom Saal or anyone else demonstrated relevance to human health and the regulatory process. This central point is conspicuously absent from vom Saal’s commentary because it does not mesh with his ideology. That’s not how science works.
Vom Saal also hauled out the old cliché about the unreliability of research funded by industry, but that’s another dog that won’t hunt.
Vom Saal should know that FDA’s various regulatory units routinely perform scientific reviews of industry-performed or funded research.
By implying an “industry-funding” conflict of interest, vom Saal neglects his own. Many university researchers, including vom Saal, are dependent to some degree on taxpayer-funded research grants. The formula among this cadre is simple: Find a way to show that something may cause harm and the tax dollars continue to flow for further research and for the care and feeding of the investigator. Research that shows no harm, on the other hand, runs the risk of turning off the spigot of grant money, and is seldom of interest to journal editors.
The FDA rejected the petition to ban BPA for a simple reason. There was no data that demonstrated harm or undue risk associated with normal consumer exposure to BPA. Recall the fundamental tenets of toxicology: Harm is a function of toxicity and exposure, and the dose makes the poison.
Scientists can and do disagree, but the incendiary approach of vom Saal and his collaborators coarsens the discussion and fails to advance either science or regulation. If there is anything toxic about BPA, it is the manner in which its ideological critics assault those with whom they disagree. Whether their unhappiness is driven by ignorance or self-interest, they have had their say and it is time to move on.
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Bill Hussein O'Stalin| 6.19.12 @ 6:24AM
Can you blame them for trying? Federal agencies have too much unregulated power which they use to throw their weight around.
I can't blame anyone who tries to influence the outcome. It's there for the taking.
Appleby| 6.19.12 @ 6:53AM
If Mommy wants a ban, Mommy wants a ban -- truth be damnd. The scream "Babies Will Die!" should be all the scientific evidence anybody will ever need -- true or false, it is Mommy's battle cry and nothing can change her mind. Hippie scum who want something harmless eliminated from American life -- stampede the Mommies, and your work is done.
The fact that this hasn't work this time is either a tribute to those who are actually able to prioritize, or that the scientists have finally gotten the ear of a smarter group of Mommies...or perhaps that people are simply sick and tired of being told that everything they eat, wear, breath or drive will kill somebody's baby.
Jack London| 6.19.12 @ 8:11AM
But the FDA and industry are phasing out BPA from baby bottles.
Also, Vom Saal has trashed the methodology of that 'human exposure study' effectively from what I can see - see here: http://toxsci.oxfordjournals.o.....1/318.full
Tom Kyba| 6.19.12 @ 11:30AM
Just as a related aside to this story, one of the main newspapers here in Winnpeg, Canada carries articles about BPA and similar subjects and virtually every one of them will quote The Center For Science in The Public Interest warning of dire consequences from whatever chemical is being discussed. A more ridiculous group of chicken littles crying havoc for their own interest you will find nowhere. My perhaps redundant point is please people, never trust a lazy self-satisfied liberal rag to actually do some investigative journalism. Anyone who has seen a list of warnings from CSPI will note that, according to them, virtually everything ever created by the hand of man is going to kill you. And thank you Mr. Miller for pointing out the phoniness of the "industry funding conflict of interest" meme these slugs keep preaching about. Simple rule of thumb:if someone these days is criticized for being in the pocket of industry regarding his or her research, said research is probably honest and well conducted.
Fast and Curious| 6.19.12 @ 11:50AM
Yes, any substance created by man can kill you. These studies are, for the most part, useless. Aspartame, if you ingest it by the gallon, can cause brain cancer in rats. Blah blah, blah. Water can kill you within an hour if you drink enough. Let's have water banned, or better yet, let's regulate the sale and packaging of water to prevent this very real possibility. Government agencies are out of control, they must be stopped.
Bill84728| 6.19.12 @ 5:21PM
John Locke, in his Second Treatise of Government, said that in a republic like ours, the government rules by the consent of the governed, through its elected lawmakers and executives.
Locke said that when our lawmakers delegate their lawmaking powers to people we did not elect, the laws (and rules and regulations) they make are not made by our consent.
Where a delegatee whose delegation of power was not consented to by us makes a rule that we didn't consent to, we don't have to obey it.
The U.S. Constitution contains no provision whatever for anyone other than Congress to make the laws that govern us, and our Congress-persons are all elected.
Period.