The Food and Drug Administration, in the aftermath of stinging criticism from a subcommittee of its own Science Board and under pressure from consumer groups, expects to make a decision before February on whether to limit exposure from bisphenol A or ban its use in polycarbonate baby bottles and other feeding products for infants.
In addition, both FDA Science Board Chairwoman Barbara McNeil and FDA's principal deputy commissioner and chief scientist, Frank Torti, said at an Oct. 31 public hearing that the agency would launch an investigation of BPA exposure levels in blood-container products and intravenous tubing.
``We need to look at this in stages,'' McNeil said. ``This will be BPA 2.''
Medical products account for anywhere from 5-9 percent of the PC market compared with less than 1 percent for baby bottles and sippy cups, according to estimates from several research groups.
Polycarbonate typically is used to make housings, connectors, tubing, surgical skin stapler housings, syringe assemblies and filterware for labs, and to make blood collection devices such as high-pressure syringes. It is also used to make disposable dental instruments, surgical face shields, blood oxygenators, blood-collection reservoirs, blood-separation devices, surgical devices, kidney-dialysis equipment, intravenous components, and centrifuge bowls.
The additional investigation means yet another challenge for the chemical industry and plastic manufacturers that use BPA.
``We think FDA should make its decisions on the best available science,'' said Cal Dooley, president of the American Chemistry Council in Arlington, Va.
``Every regulatory agency has determined that current levels of exposure are safe and until there is a determination based on science, we think the FDA ought to make decisions consistent with current processes and procedures,'' he said.
FDA's decision to look at potentially adverse health effects of other products that contain BPA does not mean the agency is leaning one way or the other in its decision making. FDA consistently has maintained that adult exposure levels to BPA and current exposure levels of BPA in baby bottles, sippy cups and the liners of metal cans that contain infant formula are safe for children.
That assessment is shared by government agencies in Japan, the European Union and even Canada, even though officials there have begun a precautionary move to ban baby bottles that contain BPA.
While welcoming criticisms from the Science Board subcommittee that issued its evaluation Oct. 28, FDA Commissioner Andrew von Eschenbach emphasized the agency must base its decisions on sound science and not make rash judgments or change regulations based on each new study.
``New cutting-edge, discovery science is in flux and must be constantly evaluated,'' he said. ``But the doctrine of today may be refuted tomorrow. We are a regulatory agency that must make public-health decisions that are science-based, enforceable and can endure.
``We cannot short-circuit or avoid this process of rigorous analysis, critical assessment and stringent validation. Only if we do that will we have the strong scientific foundation upon which to make an enduring decision to approve a product, change a drug label or issue a call for change in removal of a product,'' von Eschenbach said. ``If the evidence suggests, based on critical analysis of scientific data, that change is needed, FDA will make the changes.''
Not everyone agreed with that approach, including FDA Science Board member Larry Sasish, a pharmacist and the board's only consumer representative. His suggestion that the subcommittee ``immediately examine'' the possibility of limiting BPA exposure to infants was rejected.
``The public is expecting us to come up with a solution, and if there is some kind of uncertainty, to take steps to limit exposure until we get evidence to make a decision one way or the other,'' said Sasish, who is also a faculty member at the Lake Erie College of Medicine's School of Pharmacy in Erie, Pa.
``I sense the public's frustration with what is going on,'' he said. ``We lose credibility if we don't take some definitive action. This is why the system is losing credibility. We say `here is the science,' but we don't give the public any guidance.''
The Environmental Working Group in Washington was among several organizations that also urged FDA to take immediate action. ``We only have one chance to get it right for a child born today and for the 4 million children who will be born this year,'' Olga Naidenko, a senior scientist with the group, told the FDA Science Board. ``There is a need for immediate action to reduce BPA levels in food containers.''
Among other things, the subcommittee's report criticized the board for not explaining why it used some studies and rejected others, using a limited sample of 14 cans of infant formulas, for its failure to look at the cumulative of exposure to BPA from a variety of products or how BPA migrates when bottles are warmed in a microwave, and for not examining more closely the different rate at which children and adults metabolize BPA.
``This approach creates a false sense of security about the information that is used in the assessment,'' the report said. ``The weight of evidence suggests establishment of a more conservative margin of safety for infants.''
John Rost, chairman of the North American Metal Packaging Alliance Inc. in Washington, encouraged FDA to ``re-examine the studies'' that it originally declined to review and to do that ``as quickly and transparently as possible.''
He further urged FDA to obtain from the authors of the research ``all raw data and related information'' so the agency can make a ``full and robust review,'' noting that other countries have reviewed and rejected the findings of those studies.
``It is critically important for consumers in the United States to have confidence in the products FDA reviews and allows for consumer use,'' Rost said.
The International Formula Council in Atlanta, which represents four makers of baby formula, agreed, and defended BPA, while supporting the scientific review of new information on it.
``Because questions about the use of BPA have been raised, we continued to work with our suppliers to identify opportunities for packaging without BPA,'' IFC Executive Vice President Marti Mountford told the FDA Science Board. ``As soon as a safe and viable alternative is identified by the chemical and container industries, we stand ready to bring those new containers to market, once they have been approved for use by FDA.''
However, Diane Zuckerman, president of the National Research Center for Women & Families in Washington, said alternatives exist, including glass and polypropylene bottles and cans lined with oleoresinous vinyl or PET film lamination.