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Key Development: FDA rejection of a petition to ban bisphenol A in food packaging is expected to reduce the likelihood of personal injury claims and class-action lawsuits.
Potential Impacts: The decision's impact on lawsuits is not expected to carry over to consumer marketing pressures to find alternatives to BPA.
What's Next: FDA now must decide whether to grant the American Chemistry Council's petition to ban particular uses of BPA to formally recognize that the marketplace has abandoned those uses.
By Pat Rizzuto
The Food and Drug Administration's recent decision to reject a requested ban on the use of bisphenol A in food packaging is likely to further dissuade people from filing personal injury claims and class-action lawsuits involving the chemical, attorneys told BNA April 4.
The decision is unlikely, however, to alter consumer marketing pressures that are encouraging manufacturers to find alternative chemicals for BPA, they said.
Leonard Kurfirst, Anthony Hopp, and Brent Austin, partners in the Litigation Department and Product Liability/Toxic Tort Practice Group at Edwards Wildman Palmer LLP, discussed judicial and commercial trends involving BPA and ways FDA's decision might affect those developments.
On March 30, FDA denied the Natural Resources Defense Council's 2008 petition to ban bisphenol A from food-contact materials. NRDC said many scientific studies show the chemical is causing a wide range of health problems.
FDA said NRDC failed to provide sufficient evidence that bisphenol A harms human health to persuade the agency to pursue a rulemaking to ban the chemical (36 CRR 385, 4/2/12).
FDA's decision is likely to further deter personal injury claims or class action lawsuits involving bisphenol A, Kurfirst, Hopp, and Austin told BNA. The attorneys have tracked BPA issues for several years, although they have not litigated any cases involving the chemical.
In 2008, more than a dozen putative class actions across the country were filed against the manufacturers of baby bottles and sports bottles containing BPA, Kurfirst said.
The U.S. District Court for the Western District of Missouri disallowed those claims, and unless some evidence emerges that bisphenol A clearly causes harm and that manufacturers knew that information and failed to disclose it, Kurfirst and his colleagues said they do not expect more cases to be filed.
Austin said it is expensive to file and pursue class actions, and since they have not been successful so far, parties considering filing new cases are likely to have second thoughts.
Most of these cases were consolidated before Judge Ortrie Smith in the U.S. District Court for the Western District of Missouri, Kurfirst said. Plaintiffs had argued they would not have purchased the bottles if the alleged hazards of BPA had been properly disclosed, he said.
In July, the judge refused to certify several proposed multi-state class actions, citing the plaintiffs' failure to demonstrate that common issues of law and fact controlled the litigation (In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liability Litigation, W.D. Mo., MDL No. 1967, 7/5/11).
Smith rendered a similar ruling in December regarding a proposed class that was limited to Missouri plaintiffs, Kurfirst said (36 CRR 33, 1/9/12).
“Consistent with [our] observations over the last four years, there is nothing to suggest that a significant number of personal injury lawsuits will be filed anytime soon,” he said.
“FDA's ruling last Friday makes it even more unlikely that this trend will change,” Kurfirst added.
“The medical literature has failed to demonstrate that any specific illness or disease is likely to develop in humans at the low levels of exposure that may occur from using food and beverage containers that contain BPA,” he said.
Mitchell Cheeseman, who joined Steptoe & Johnson LLP in 2010 after working at FDA for 20 years, where he was acting director of FDA’s Office of Food Additive Safety, told reporters April 5 that FDA has spent 10 staff years on BPA since 2007 and the federal government has spent more than $40 million to fund studies evaluating the safety of the chemical.
That effort has led the agency to conclude that current uses are safe, although it will obtain additional information over the next few years from ongoing studies, Cheeseman said during a press briefing organized by the International Food Information Council. The council is a nonprofit educational organization funded primarily by the food industry but also through grants from the government and private foundations.
Kurfirst said the documents FDA released explaining its decision laid out a well-supported, logical analysis explaining why the scientific evidence NRDC's petition relied on did not support a ban.
FDA's letter to NRDC essentially applied the “Bradford Hill criteria” to the human studies that the council cited, Kurfirst said. The criteria, developed by British epidemiologist Austin Bradford Hill in 1965, provide guidelines to evaluate the scientific strength of studies that suggest a causal relationship between exposures to a chemical or agent and a subsequent human illness or disease.
Courts apply the criteria via the Reference Manual on Scientific Evidence, which helps attorneys and judges understand when there is sufficient scientific evidence to support an allegation of harm, Kurfirst said.
As for the animal and in vitro studies cited by NRDC, FDA relied largely upon its Redbook 2000, or Guidance for Industry and Other Stakeholders Toxicological Principles for the Safety Assessment of Food Ingredients, which provides toxicological principles to assess the safety of food ingredients, Kurfirst said.
If the assessment by Kurfirst and his colleagues is correct, and the wave of litigation against BPA has crested, the possibility of other litigation remains.
On April 4, NRDC spokeswoman Suzanne Struglinski told BNA the council continues to evaluate its legal options.
NRDC is pressing FDA to divulge information that will help that evaluation, NRDC attorney Nicholas Morales said.
FDA is providing NRDC with exposure data, health effects information, regulatory cost projections, and other documents through a 2011 Freedom of Information Act challenge NRDC filed in federal district court, Morales told BNA (Natural Resources Defense Council v. FDA, S.D.N.Y., No. 11-cv-08662, order issued 2/21/12).
On Feb. 21, the court set a timelime by which FDA had to begin providing various types of documents. The first package of information was due April 2, with additional documents being provided through July 16.
By Aug. 15, NRDC must notify FDA whether it intends to challenge any withholdings or the adequacy of the agency's efforts to provide information authorized under FOIA.
The commercial implications of FDA's decision, meanwhile, are separate from its legal impact.
Kurfirst, Austin, and Hopp predicted that despite FDA's assurances concerning the safety of BPA, the chemical's use is likely to decline.
“BPA is being chased out of the marketplace by consumer advocates,” Hopp said.
Consumers are worried about bisphenol A, and retailers and other companies are pushing for alternatives, he said.
Four food-additive petitions filed with FDA ask the agency to ban various uses of bisphenol A, arguing that marketplace has already or is in the process of abandoning them.
Under regulations FDA issued to implement Section 409(i) of the Federal Food, Drug, and Cosmetic Act, a petitioner may propose that FDA amend a food additive regulation if the petitioner can demonstrate that there are “old uses” of the additive that the marketplace has “abandoned.”
The American Chemistry Council filed a petition in 2011 asking FDA to ban bisphenol A's use in “sippy cups” and baby bottles as a formal recognition that companies no longer use the chemical to make those products.
Rep. Edward Markey (D-Mass.) also used the marketplace abandonment argument in three food-additive petitions he filed March 16 that asked FDA to no longer allow the use of bisphenol A in:
As evidence, Markey's petitions described baby bottles and other food packages made with chemicals other than BPA that are available on the market (36 CRR 362, 3/26/12).
Eleven states have already passed legislation or issued administrative orders banning some uses of BPA, focusing primarily on baby bottles and sippy cups, according to SaferStates, a network of diverse environmental health coalitions and organizations.
FDA determined the American Chemistry Council's petition contained sufficient evidence that soliciting public comment on its proposed ban of particular BPA uses was warranted. FDA is accepting comment on that petition through April 17.
FDA was still reviewing Markey's petitions as of April 4, an agency spokesman told BNA. If the agency accepts the petitions for review, it would probably publish a notice in the Federal Register by mid-May, he said.
Lynn Bergeson, an attorney with Bergeson and Campbell P.C., offered thoughts on whether the approach FDA offered to release a decision on a controversial issue offered lessons for other federal agencies finding themselves in similar position.
“Regardless of whether you concur with the decision to deny NRDC's petition to revoke all regulations authorizing the use of BPA, FDA's rollout of its decision was well done,” Bergeson said.
“The decision itself is principled and well-written and the wording decisive and clear. FDA appears to have made a decision firmly to reject the petition and not be tempted to provide a little something for everyone to help ensure a softer landing,” she said.
She also praised the agency for providing notice of when it would release the decision. That enabled interested parties to prepare and “perhaps avoid some of the chaos that typically ensues when significant regulatory or policy issues seemingly drop from the sky with no warning,” Bergeson added.
By Pat Rizzuto
FDA has created a website with extensive information about bisphenol A, including the regulatory context in which it must review the chemical, at http://www.fda.gov/newsevents/publichealthfocus/ucm064437.htm.
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