In re Natural Res. Def. Council, No. 10–1142.

• Court: United States Courts of Appeals. United States Court of Appeals (District of Columbia)
• Writing for the Court: Before: HENDERSON, ROGERS and KAVANAUGH, Circuit Judges.
• Citation: 645 F.3d 400
• Parties: In re NATURAL RESOURCES DEFENSE COUNCIL, Petitioner.
• Docket Number: No. 10–1142.
• Decision Date: 17 June 2011

645 F.3d 400

In re NATURAL RESOURCES DEFENSE COUNCIL, Petitioner.

No. 10–1142.

United States Court of Appeals, District of Columbia Circuit.

Argued April 14, 2011.Decided June 17, 2011.

[645 F.3d 402]

On Petition for Writ of Mandamus to the Food and Drug Administration.Aaron Colangelo argued the cause for petitioner. With him on the briefs were Levi Jones and Avinash Kar.Anne Murphy, Attorney, U.S. Department of Justice, argued the cause for respondent. With her on the brief were Tony West, Assistant Attorney General, Douglas N. Letter, Attorney, Eric M. Blumberg, Deputy Chief Counsel, Food & Drug Administration, and Karen E. Schifter, Senior Counsel, Department of Health and Human Services.Before: HENDERSON, ROGERS and KAVANAUGH, Circuit Judges.Opinion for Court by Circuit Judge ROGERS.ROGERS, Circuit Judge:

This 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. 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. We hold that exclusive jurisdiction over citizen petitions lies in the district court, and accordingly we dismiss the petition.

I.

Section 409 of the Act on “food additives” provides that “[a]ny person may, with respect to any intended use of a food additive, file with the Secretary [of the Department of Health and Human Services] a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.” 21 U.S.C. § 348(b)(1). The petition must include specified information and data, id. § 348(b)(2), and the Secretary must issue an order adopting a regulation or denying the petition within 180 days after the petition is filed, id. § 348(c)(2). Within 30 days of publication of such order, “any person adversely affected ... may file objections,” and the Secretary “shall, after due notice, as promptly as possible hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections” and “[a]s soon as practicable after completion of the hearing ... shall by order act upon such objections....” Id. § 348(f)(1). Judicial review of an order amending or repealing a regulation is in the U.S. Court of Appeals, in the circuit where the adversely affected petitioner resides or has his principal place of business, or in this court. Id. § 348(g).

Section 409 directs the Secretary by regulation to “prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations.” Id. § 348(i). Pursuant to this authority, FDA regulations provide two options for seeking repeal or amendment of a food additive regulation.¹ The first is a food additive petition. See 21 C.F.R. § 171.1. When a food additive petition

[645 F.3d 403]

seeks promulgation of a new regulation, the petitioner bears the burden of showing that the additive will have its “intended physical or other technical effect,” id. § 171.1(c), and “will be safe for its intended use,” id. The petitioner is required to submit a considerable amount of supporting data, including the additive's chemical properties, and data on quantity and proposed use. See id. When a food additive petition seeks to amend an existing regulation, the petitioner must include “full information on each proposed change,” but may rely on statements in the original petition where no change is proposed. Id. The FDA must grant or deny a food additive petition in accordance with the statutory timeline in section 409(c)(2) of the Act. See id. § 171.100.

The second method to request amendment or repeal of a food additive regulation is by citizen petition. This is addressed in section 10.30 of Part 10, which contains the general administrative practices and procedures for the Act. A citizen petition is required to include far less supporting data than the food additive petition, and the petitioner does not bear the burden of establishing that an additive is safe or unsafe. Compare 21 C.F.R. § 10.30, with id. § 171.1. While the Act provides that a food additive petition can only be granted or denied, see 21 U.S.C. § 348(c), the regulation allows the FDA to grant or to deny a citizen petition or to “[p]rovide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information,” 21 C.F.R. § 10.30(e)(2). In ruling on a citizen petition, the FDA is to take into consideration: “(i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute.” Id. § 10.30(e)(1). The FDA is required to respond within 180 days of receipt of the petition, id. § 10.30(e)(2).

The provisions on citizen petitions apply “except to the extent that other sections of this chapter apply different requirements to a particular matter.” Id. § 10.30(a). Thus, a petitioner submitting new data to support the amendment or repeal of a regulation must do so through a food additive petition. Id. § 171.130(b). When seeking to ban a substance from use in food, a petition must include “an adequate scientific basis.” Id. § 189.1(c). In any event, the FDA can “publish a proposal to establish, amend, or repeal a regulation ... on the basis of new scientific evaluation or information.” Id.; see id. § 171.130(a); see also id. § 10.30(h).

II.

On October 21, 2008, the NRDC submitted a “Citizen Petition” to the FDA “under section 409 of [the Act], and pursuant to 21 C.F.R. §§ 10.30, 171.130, and 189.1.” Citizen Petition 1 (Oct. 21, 2008). The petition asked the FDA to “establish a regulation prohibiting the use of BPA ... in human food and [to] revoke all regulations permitting the use of a food additive that results in BPA becoming a component of food.” Id. The petition did not challenge the FDA's original decision to permit BPA to be used as a food additive; rather, it sought a change in the regulations based on new data. See id. at 6, 10. In support of its request, the NRDC relied on section 409(c)(3) and (c)(5) of the Act, which require that the safety of a food additive must be established before its use can be sanctioned by the FDA, id. at 5–6 (citing 21 U.S.C. § 348(c)(3), (5)), and on scientific data to show the dangers of BPA. For example, it pointed to animal and human

[645 F.3d 404]

tissue studies indicating that “levels of BPA ranging from 5 to 10 ppb leach[ ] from baby bottles heated with water,” id. at 7–8, and otherwise indicating that humans are “widely exposed to BPA” at “levels ... well within the range of concern based on animal studies.” Id. at 8. In citing new studies, it noted the association of BPA exposure and disruption of female and male reproductive toxicity (even across generations), various forms of cancer, and interference with the thyroid hormone, as well as an association between BPA and diseases such as diabetes, cardiovascular disease, and obesity. Id. at 10–13. The NRDC asserted that “[t]he weight of the scientific evidence now shows that human exposure to BPA can not [sic] be confirmed safe,” id. at 9, and, based on the studies by different laboratories unaffiliated with BPA manufacturers or users, “strongly disagree[d]” with the two studies on which the FDA relied in concluding that “an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.” Id. at 14 (internal quotation marks omitted).

The FDA acknowledged receipt of the NRDC's citizen petition shortly after receiving it. When five months had passed without further response, the NRDC wrote to the Division of Dockets Management, inquiring...