As part of its ongoing campaign to persuade government authorities to prohibit the use of bisphenol A (BPA), the Natural Resources Defense Council (NRDC) recently filed a lawsuit in the D.C. Circuit Court of Appeals seeking to force the Food and Drug Administration (FDA) to take action on a petition the organization filed in October 2008 requesting that the agency prohibit the chemical’s use in food packaging. In re: NRDC, Inc., No. 10-1142 (D.C. Cir., filed June 29, 2010).

One year ago, NRDC also submitted a petition to California EPA’s Office of Environmental Health Hazard Assessment, requesting that BPA be added to list of chemicals “known to the state to cause reproductive toxicity” under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Prop. 65).

In its lawsuit, NRDC notes that more than 600 days have passed since its FDA petition was filed, and the NRDC reiterates its contentions that (i) FDA has the authority to regulate food additives such as BPA; (ii) BPA in food packaging and food contact materials leaches into food products and can be found in the urine samples of 93 percent of Americans tested; and (iii) BPA exposure “at current levels presents a clear
risk to human health.”

The bulk of NRDC’s brief focuses on the organization’s standing to seek a writ of mandamus and how the matter meets relevant legal standards that support the grant of such writs. Among other matters, NRDC argues that FDA has no competing priorities justifying the delay in addressing its petition, citing FDA’s express concerns about BPA’s potential effects “on the brain, behavior, and prostate gland of fetuses, infants and children.”

Attached to the brief are affidavits, including one from a physician discussing the purported “health effects of endocrine-disrupting chemicals, including bisphenol A (BPA).” It outlines scientific research on this topic and refers to the governmental authorities that have taken action to prohibit the chemical’s use in products, such as baby bottles and sippy cups, to which infants and toddlers would be exposed.

The American Chemistry Council responded to news about the lawsuit by issuing a statement, saying that the industry trade group “believes that the scientific process and the public interest are both best served by allowing the FDA to complete its ongoing review of the science surrounding the safety profile of BPA.” The council also stated, “In an update in January, the U.S. Department of Health and Human Services and the FDA made it clear that BPA ‘is not proven to harm children or adults…’ This is consistent with a draft assessment issued by FDA in 2008, and the scientific conclusions of many other government regulatory agencies around the world.”

In a related development, the Australian government has reportedly reached an agreement with major retailers to phase out the sale of BPA containing baby bottles, beginning July 1, 2010. While Parliamentary Secretary for Health Mark Butler noted that “Food Standards Australia New Zealand (FSANZ) has evaluated the safety of BPA and plasticizers in baby bottles and concluded that levels of intake of BPA or plasticizers are very low and to not pose a risk to babies’ health,” he commented that the voluntary agreement was designed to allay public concerns about the chemical. See ACC Press Release, June 29, 2010; FoodProductionDaily.com, June 30, 2010.

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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