Monday, June 20, 2011

In Re: Natural Res. Defense Council

Jun 17: In the U.S. Court of Appeals, D.C. Circuit, Case No. 10-1142. On Petition for Writ of Mandamus to the Food and Drug Administration. The appeal concerns whether this court or the district court has jurisdiction over matters relating to a citizen petition filed pursuant to Food and Drug Administration (FDA) regulations promulgated under the Food, Drug, and Cosmetic Act (the Act) , 21 U.S.C. §§ 301 et seq.
    The Appeals Court explains that because its citizen petition to revoke regulations permitting Bisphenol A (BPA) to be used as a food additive, see, e.g, 21 C.F.R. § 177.1555; id. § 177.1595, has been pending since October 21, 2008, the Natural Resources Defense Council (NRDC) seeks what amounts to a writ of mandamus directing the FDA to issue a final decision on its petition. The Appeals Court rules, "We hold that exclusive jurisdiction over citizen petitions lies in the district court, and accordingly we dismiss the petition." The Appeals Court says further, "Accordingly, because the NRDC cannot show that jurisdiction over its citizen petition lies exclusively in this court, or that all final FDA action on its petition would be directly and exclusively reviewable in this court, we dismiss the petition for lack of jurisdiction."
    In further explanation, the Appeals Court said, "during oral argument, counsel for the NRDC suggested that section 10.30(e)(1) of the regulations, providing that the FDA 'shall . . . rule upon each petition . . . taking into consideration . . . time requirements established by statute,' requires the FDA to comply with the statutory timeline in section 409(c)(2) of the Act, and thereby establishes that the citizen petition process is governed by the requirements of section 409 generally. Oral Arg. Recording at 3:02-3:23. The NRDC referred to section 10.30(e) in its Petition at 8, but only in the context of listing the three possible responses by the FDA to a citizen petition. This was insufficient to put the FDA on notice of the argument presented during oral argument. Ordinarily this would mean that the argument is forfeited. Cf. U.S. v. Southerland, 486 F.3d 1355, 1360 (D.C. Cir. 2007). Inasmuch as the NRDC's petition is filed as an original proceeding in this court and the issue goes to our jurisdiction, however, we reach the merits. See Shays v. FEC, 528 F.3d 914, 922–23 (D.C. Cir. 2008). The FDA correctly argued in its response that section 10.30(e)(1) does nothing more than make the statutory deadlines one of several factors that the FDA must consider and weigh in its discretion. This provision simply highlights the difference between the food additive petition review process, which is subject to the statutory timeline, and review of a citizen petition established by regulation, which treats the timeline as a guideline for the FDA to consider and allows for a "tentative response" by the FDA. The NRDC's reliance on section 10.30(e) is thus insufficient to support its position that section 409 applies generally to its citizen petition."
    Access the complete opinion (click here). [*Toxics, *CADC] (click here for information on getting the links and more information about eNewsUSA).

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