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Center for Science In the Public Interest v. United States Food and Drug Administration

United States District Court, D. Columbia.

November 21, 2014



For UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG in her official capacity as Commissioner, United States Food and Drug Administration, Defendants: Lauren Hash Bell, Lauren Elizabeth Fascett, LEAD ATTORNEYS, U.S. DEPARTMENT OF JUSTICE, Washington, DC; Andrew E. Clark, U.S. DEPARTMENT OF JUSTICE, Washington, DC.

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JAMES E. BOASBERG, United States District Judge.

Mercury is toxic, especially to young children and developing fetuses. Because

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seafood contains mercury, the Environmental Protection Agency and the Food and Drug Administration have posted online recommendations for seafood consumption targeted at young children and women of child-bearing age. Plaintiffs Center for Science in the Public Interest and Mercury Policy Project, concerned that these recommendations were not reaching at-risk members of the public, petitioned FDA in 2011 to initiate a rulemaking that would require versions of the online recommendations to be included in seafood labels and posted where seafood is sold. The agency has neither approved nor denied the petition.

At the time Plaintiffs petitioned the Administration, it was in the midst of a large-scale scientific inquiry designed to reevaluate its approach to mercury. The problem FDA faces is that, although mercury found in seafood has a deleterious effect on early neurodevelopment, the seafood itself provides nutrients that promote healthy growth. The agency, accordingly, has long been working to develop a method to accurately assess potential risks posed by mercury, balanced against the known benefits of eating fish. That project has now drawn to a close, and, as a result, FDA and EPA are currently drafting new recommendations to replace those currently posted online.

In the meantime, several years have passed since Plaintiffs petitioned FDA. On March 10, 2014, they brought this suit, seeking an order compelling the Administration to act on their petition. The parties now cross-move for summary judgment. Because the Court finds that FDA's delay in responding to Plaintiffs is not so egregious as to warrant intervention at this time, it will grant Defendants' Motion for Summary Judgment and deny Plaintiffs'.

I. Background

A. 2004 Advisory

Airborne mercury, emitted from sources like coal-fired power plants, is deposited into the ocean, is converted into methylmercury, and enters the human body through our consumption of seafood. See Compl., ¶ ¶ 37-38. Methylmercury -- which the Court will for convenience refer to simply as " mercury" -- is toxic. See id. It is particularly harmful to fetuses and young children, for whom it can impair neurodevelopment. See id., ¶ 38. In 2004, due to these risks, FDA and EPA issued an online advisory entitled, " What You Need to Know About Mercury in Fish and Shellfish." See id., ¶ 39; Pl. Mot., Declaration of Summer Kupau-Odo, Exh. 4 (2004 Advisory).

The 2004 Advisory informs consumers that " some fish and shellfish contain higher levels of mercury that may harm an unborn baby or young child's developing nervous system." See 2004 Advisory at 1. Noting that the health " risks from mercury in fish and shellfish depend on the amount . . . eaten and the levels of mercury in the fish," id., FDA and EPA issued three recommendations for women who might become pregnant, pregnant women, women who are nursing, and children (" Target Group" ): (1) do not eat shark, swordfish, tilefish, or king mackerel; (2) limit albacore tuna consumption to six ounces per week; and (3) eat up to twelve ounces of low-mercury seafood per week. Id. at 2; Compl., ¶ 39. The advisory suggests the same for young children, but with reduced portions. See 2004 Advisory at 2.

B. Plaintiffs' Citizen Petition

On July 5, 2011, relying on studies showing that many consumers still did not know about the risks posed by mercury in seafood, Plaintiffs petitioned FDA to initiate a

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rulemaking to better disseminate the 2004 Advisory, which could otherwise only be found online. See Kupau-Odo Decl., Exh. 7 (Plaintiffs' Petition) at 15. They asked FDA to consider regulations that would:

a. " Provide for informational labeling on packaged seafood to generally reflect the [2004 Advisory]" ;
b. " Require grocery stores to post the seafood consumption recommendations [contained in the 2004 Advisory] at the point of sale of unpackaged, fresh seafood, simplified into a user-friendly chart that is aimed at the TARGET GROUP" ; and
c. " Provide for informational mercury level and consumption limit labeling, on packaging and/or at the point of sale, for seafood species with moderate and high mercury content that are not otherwise listed in the [2004 Advisory], to specify the level of mercury content and/or the recommended consumption limit for the TARGET GROUP . . . ."

Id. at 5-6 (footnote omitted); Compl., ¶ 45.

FDA has the power to compel this type of labeling on commercial fish by authority set out in the Federal Food, Drug, and Cosmetic Act (FDCA). Specifically, the Administration may require information to appear in food labels if it determines that, absent that information, the labels would be false or misleading. See 21 U.S.C. § § 371(a), 343(a)(1), 321(n).

It is undisputed that citizens may petition FDA to issue regulations and orders in this manner. See 21 C.F.R. § § 10.30, 10.25(a)(2). In this case, the Administration acknowledged receipt of the petition, but Plaintiffs did not receive any further communication for the next six months. See Compl., ¶ 49. On January 26, 2012, Plaintiffs alerted the agency to its failure to respond. See id. Six months later, on August 8, 2012, FDA sent Plaintiffs a tentative response letter, stating that it " had not yet reached a decision on [the P]etition because . . . the ongoing review and analysis of the science [was] not yet completed." See id., ¶ 50; Kupau-Odo Decl., Exh. 10 (Tentative Response). In the letter, the agency noted that it " hope[d] to be able to complete this review in the near future," that it was " actively considering the issues raised by [the] citizen petition," and that it " intend[ed] to issue a final response as soon as possible after this review is completed." See Tentative Response.

C. FDA Action on Mercury

At the time Plaintiffs petitioned FDA, it was in the process of evaluating its approach to mercury in seafood. According to the Administration, since publishing the 2004 Advisory, substantial evidence has emerged that fish consumption by pregnant women and young children can improve neurodevelopment even though fish contain mercury. See Def. Mot. & Opp., Declaration of Michael Landa, ΒΆ 12. To address this issue, starting in approximately 2006, FDA began developing a methodology for assessing the net effects of fish consumption on ...

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