FDA to Re-Examine Bisphenol A Data; Congress Concerned About Industry Involvement in Safety Debate
Food and Drug Administration (FDA) Commissioner Margaret Hamburg has reportedly indicated that the agency will review its 2008 decision that bisphenol A (BPA) in children’s food and beverage containers is, for the most part, safe. An agency spokesperson has apparently indicated that a new decision on the chemical, which is also used to seal canned food containers, will be released within “weeks not months.”
The action comes after House Energy and Commerce Committee Chair Henry Waxman (D-Calif.) asked the commissioner to reconsider the agency’s decision in light of “longstanding questions about the scientific data relied on by FDA under the previous Administration, as well as new press accounts detailing the influence of industry lobbyists on FDA’s scientific analyses.”
Waxman cites several Milwaukee Journal-Sentinel articles, based on agency emails and a leaked industry report of a public relations strategy meeting, apparently indicating that (i) “when FDA conducted its review of BPA, it ‘relied on chemical industry lobbyists to examine bisphenol A’s risk, track legislation to ban it, and even monitor press coverage’”; (ii) “FDA regulators sought information from [an industry trade group] to discredit a Japanese study that found [BPA] caused miscarriages”; (iii) “industry representatives discussed ‘using fear tactics [e.g. “Do you want to have access to baby food anymore?”]’”; and (iv) “industry officials ‘hammered out’ a public relations strategy they hoped would include the ‘holy grail’ of ‘showcasing a pregnant woman to talk about the chemical’s benefits.’”
According to Waxman’s June 2, 2009, letter, “These new press accounts raise serious questions about the extent to which FDA relied on the industry for independent scientific advice under the previous Administration.” In addition to asking the agency to reconsider its position on BPA, Waxman calls for the agency to “examine its processes to determine whether its interaction with and reliance on industry groups was appropriate in this case, and whether changes are needed going forward.”
The same day, Waxman wrote to the chair of the North American Metal Packaging Alliance, Inc. (NAMPA) raising the issue of the purported joint trade association meeting “during which industry officials discussed a public relations strategy to counter efforts to regulate BPA.” He requested that NAMPA provide to the committee by June 16 all materials relating to BPA meetings in April and May 2009, a list of all attendees and a list of all members of the “BPA Joint Trade Association.”
While several NAMPA spokespersons have reportedly confirmed that the industry meeting took place and that the leaked memo accurately summarized some of the points made during this “brainstorming session,” NAMPA Chair John Rost also indicated that the summary was incomplete and did not accurately reflect all of the discussions held over a five-hour period. NAMPA continued to accuse the media of selectively reporting only negative findings, reportedly stating that “BPA’s use in metal packaging is critical to protecting food contents from microbiological contamination by enabling high temperature sterilization.” According to one news source, NAMPA dismissed the leaked meeting memo as “blatantly inaccurate and fabricated,” but defended the meeting’s rationale, asking whether it should “come as a surprise that our industry seeks to defend the legitimate scientific process that has concluded BPA is safe to use in food contact applications?”
A spokesperson for the Environmental Working Group, which advocates banning the chemical, reportedly responded to news about the leaked memo by saying, “The BPA industry has adopted the tactics of tobacco and asbestos—when they had no science to make their case, they resorted to scare tactics and public relations. It seems pretty desperate.”
Meanwhile, the European Food Safety Authority (EFSA) and the UK Food Standards Agency (FSA) have reportedly confirmed their approval of BPA’s use in food-contact materials like hard, clear food containers and sealants in the linings of food and beverage cans. EFSA was quoted as saying, “None of the studies which have so far been published have brought into question EFSA’s previous findings on BPA.”
According to an FSA spokesperson, “The view of the FSA on the chemical has not changed. We do not believe that UK consumers are exposed to levels of BPA that would be considered a danger.”
And in related developments, Connecticut’s House and Senate have apparently approved legislation by veto-proof majorities that would prohibit bisphenol A in products marketed for use by children younger than age 3, while California’s Senate has approved a bill that calls the chemical a “known hormone disruptor” and would limit BPA to 0.1 ppb in any liquid, food or beverage intended primarily for infants or children ages 3 or younger. A similar proposal reportedly failed in the California Assembly in 2008 where it faced stiff industry opposition.
The American Chemistry Council has apparently criticized the California bill as “not based on science” and one that “will not improve public health.” ACC accuses the state’s legislators of bowing “to pressure from vocal special interest groups,” claiming, “If this bill becomes law, it will do nothing to enhance product safety; it will, however, result in reduced product choice for consumers and needlessly more expensive food products.” See Milwaukee Journal-Sentinel, May 29, 2009; The Washington Post, May 31, 2009; Product Liability Law 360, May 29 and June 3, 2009; FoodQualityNews.com, June 1, 2009; and FoodProductionDaily.com, June 2 and 3, 2009.
