Food and Drug Administration officials “say they are powerless to regulate BPA” because of a quirk in their rules, according to a story that ran Sunday in the Milwaukee Journal Sentinel. It comes from a reporter who has made an award-winning habit of documenting the politics that have helped make the hormone-mimicking bisphenol-A a chemical of choice for many manufacturers.
Meg Kissinger’s latest followup on BPA politics comes on the heels of a turnabout in FDA policy, last Friday, on the safety of this chemical, which is used widely as the basis of polycarbonate plastics, of food-can liners and of dental sealants. Oh yes, and let’s not forget: Handling cash-register receipts may prove the biggest source of BPA exposure.
Back in 1963, FDA’s regulators classified BPA as an indirect food additive that is GRAS — “generally regarded as safe.” Manufacturers get a bye when using a GRAS substance. They don’t even have to report its use in food-contact applications.
That’s why, Kissinger reports, despite there being hundreds of different BPA recipes for epoxy linings used to protect the interior of food cans and the lids on jars, “manufacturers are not required to disclose to FDA the existence or nature of these formulations.” Reassuring, huh?
She reports that e-mails her team at the Journal Sentinel pried out of FDA under the Freedom of Information Act show “industry scientists wrote sections of the FDA’s earlier draft declaring the chemical [BPA] to be safe for all uses. It later obtained e-mails that showed industry lobbyists were given priority treatment in scrutinizing studies and that FDA regulators looked to them for advice on how to deal with the media . . . [sometimes borrowing] the same tactics and some of the same people as the tobacco industry to downplay the health risks of their products.”
Bottom line: Once a substance is declared GRAS, regulators pretty much have their hands tied on ferreting out use data, and thereby analyses of likely public exposure. Unless Congress gets involved.
It shouldn’t take that. Worrisome health-effects studies should be sufficient for regulators to be able to reevaluate a chemical’s GRAS status. Especially when it comes to chemicals that exhibit effects through a mechanism (like endocrine disruption, for BPA) not yet on the radar screen when the materials were originally evaluated. Especially chemicals that make contact with babies and young children. Especially chemicals for which safer alternatives exist. Indeed, new safety reviews might actually prod the creation of greener alternatives or new markets for them.
Kissinger, M. 2010. FDA says it's unable to regulate BPA as 'indirect food additive,' substance is exempt from scrutiny. Milwaukee Journal Sentinel (Jan. 17). [Go to]
_____. 2009. BPA found in 90% of newborns. Milwaukee Journal Sentinel (Dec. 3). [Go to]
_____. 2009. FDA relied heavily on BPA lobby: Regulators actively reached out to industry, e-mails show. Milwaukee Journal Sentinel (May 16). [Go to]