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Parties Involved:
Natural Resources Defense Council
Petitioner

Document Text:

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United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued April 14, 2011 Decided June 17, 2011

No. 10-1142

IN RE: NATURAL RESOURCES DEFENSE COUNCIL,

PETITIONER

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.

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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

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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 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

1

 The Secretary has redelegated authority under the Act to the

FDA. See FDA Staff Manual Guide § 1410.10 (2005); 69 Fed. Reg.

17,285 (Apr. 2, 2004). 

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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

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“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 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 when the FDA intended to

respond and noting that under the Act “the FDA’s final

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determination of this petition was due within 90 days, and is

now several months overdue.” Letter from Aaron Colangelo,

NRDC, to Lyle D. Jaffe, Division of Dockets Management,

FDA (Apr. 20, 2009). Two weeks later, on May 6, 2009, the

Office of Food Additive Safety provided a “tentative response”

pursuant to 21 C.F.R. § 10.30(e), listing the “limited availability

of resources and other agency priorities” as reasons for not

reaching a final decision on the citizen petition. Letter from

Laura Tarantino, Director, Office of Food Additive Safety,

FDA, to Sarah Janssen & Aaron Colangelo, NRDC (May 6,

2009). Thirteen months passed and the NRDC received no

further response to its citizen petition. 

III.

The NRDC filed in this court on June 29, 2010, a petition

seeking to have the court establish “an enforceable deadline” by

which the FDA “must respond . . . with either a denial or a

responsive rulemaking.” Petition at 22. The FDA responded by

maintaining that this court lacks jurisdiction over the petition

because the FDA’s final action on the citizen petition is

reviewable in the district court and that court can also entertain

an Administrative Procedure Act (“APA”) claim for

unreasonable delay.

In Cutler v. Hayes, 818 F.2d 879 (D.C. Cir. 1987), this court

observed that the Act “contains no single, overarching provision

governing judicial review. Instead, discrete agency actions are

subject to specialized review provisions.” Id. at 887 n.61. 

Although the Act has been amended since then, section 409 of

the Act continues to vest exclusive jurisdiction over challenges

to orders of the FDA, “including any order thereunder with

respect to amendment or repeal of a regulation issued under this

section . . . in the United States Court of Appeals for the circuit

wherein [the “adversely affected”] person resides or has his

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principal place of business, or in the United States Court of

Appeals for the District of Columbia Circuit.” 21 U.S.C.

§ 348(g)(1). Because “courts of appeals have only such

jurisdiction as Congress has chosen to confer upon them,”

Cutler, 818 F.2d at 887 n.61 (citations omitted), this court

instructed that where a regulation is not based on a statutory

provision vesting exclusive jurisdiction in the courts of appeals,

jurisdiction lies in the district courts, id.; see Wellife Products v.

Shalala, 52 F.3d 357, 358 (D.C. Cir. 1995); 28 U.S.C. § 1331. 

The only exception is when the final agency action will be

exclusively reviewable in the courts of appeals and the court is

acting to protect its future jurisdiction. Telecomms. Research &

Action Ctr. v. FCC (“TRAC”), 750 F.2d 70, 78–79 (D.C. Cir.

1984). This is a narrow exception, however. This court will not

“assert jurisdiction on the basis of hypothetical scenarios,” and

the exception “is not properly extended to cases where the basis

of prospective jurisdiction is a speculative chain of events.”

Moms Against Mercury v. FDA, 483 F.3d 824, 827 (D.C. Cir.

2007); see also Nat’l Mining Ass’n v. Mine Safety and Health

Admin., 599 F.3d 662, 672–73 (D.C. Cir. 2010).

The FDA adopts this position in its Response to the

Petition, maintaining that the citizen petition procedure is nonstatutory and that judicial review of final agency action on a

citizen petition is through APA review in the district court. It

further maintains the TRAC exception does not apply because

jurisdiction over its final action on the NRDC’s citizen petition

may well lie in the district court. It notes, as this court recently

reaffirmed: “If judicial review of an FDA action or inaction is

not provided for in the Act, challenges to such actions may be

brought only in the district court.” Moms Against Mercury, 483

F.3d at 827.

In reply, the NRDC argues that section 409 governs the

FDA’s response to its citizen petition. Although acknowledging

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that its petition requesting the repeal of regulations allowing the

use of BPA as a food additive was filed as a citizen petition

under section 10.30 of the regulations, and not as a food additive

petition under section 171.1, the NRDC nonetheless maintains

that because the citizen petition regulation must conform to the

requirements of section 409 of the Act, this court has

jurisdiction. In particular, the NRDC maintains that because

sections 171.130 and 189.1, which regulations were

promulgated under section 409 of the Act, direct petitioners to

“Part 10” of the regulations, and Part 10 contains the citizen

petition provision, “[a] citizen petition seeking repeal of food

additive regulations is authorized by [section 409(i),] 21 U.S.C.

§ 348(i)[,] and subject to the requirements of [section 409].” 

Reply Br. 5. 

This argument fails for a number of reasons. First, it

ignores the requirement in section 171.130(b) that a food

additive petition must be filed when new data is presented to

support a request for repeal of an existing regulation. Had the

NRDC done so, then section 409 of the Act would apply. 

Second, the NRDC’s argument overreads section 189.1(c),

which provides only that a petition to “establish, amend, or

repeal a regulation . . . shall include an adequate scientific basis

to support the petition, pursuant to part 10 of this chapter”; it

does not indicate that a citizen petition may be used to repeal a

food additive regulation or ban a particular food additive. Third,

the NRDC inaccurately states that Part 10 “relates to citizen

petitions,” Reply Br. 4, when section 10.25 in Part 10 recognizes

food additive petitions as one way to request FDA action and

Part 10 otherwise covers all administrative practices and

procedures under the Act. There is, then, nothing in the

regulations identified by the NRDC to support its position that

the citizen petition process, which can be used for any type of

petition under the Act (not just one relating to food additives),

is governed by section 409 of the Act.

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Further, as the FDA points out, lawsuits involving citizen

petitions are regularly heard in the district courts. See, e.g., Teva

Pharm., USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008);

Action on Smoking and Health v. Harris, 655 F.2d 236 (D.C.

Cir. 1980). Much as the NRDC seeks through its current

petition, this court has held that in cases brought under APA

§ 706(1) seeking to “compel agency action unlawfully withheld

or unreasonably delayed,” 5 U.S.C. § 706(1), when the agency

has failed to act within a “reasonable time,” id. § 555(b),

jurisdiction lies in the district court. Mashpee Wampanoag

Tribal Council, Inc. v. Norton, 336 F.3d 1094, 1099–1100 (D.C.

Cir. 2003). Community Nutrition Institute v. Novitch, 583 F.

Supp 294 (D.D.C. 1984), upon which the NRDC relies, is not to

the contrary; there the district court ruled this court had

jurisdiction “because the FDA has issued final orders with

respect to all of [plaintiffs’] requests,” id. at 296, unlike in the

instant case. To the extent the district court there suggested that

if the plaintiffs sought reconsideration of the challenged

regulation and the agency denied reconsideration, then the

“plaintiffs may be able to seek review in the court of appeals at

that time,” id. (emphasis added), this hypothetical presumes the

existence of a final agency order. The FDA’s “tentative

response” of May 6, 2009 is, by its plain terms, not such an

order.

The TRAC exception, as the FDA suggests, is inapplicable

because exclusive jurisdiction over any final agency action on

the NRDC’s citizen petition will not necessarily be in this court. 

The NRDC maintains that because submission of a citizen

petition must invoke the regulatory process that section 409

mandates, any final order by the FDA would be exclusively

reviewable in the courts of appeals. But the NRDC ignores the

option that the FDA has to provide a tentative response to a

citizen petition, see 21 C.F.R. § 10.30(e)(2)(iii), as occurred

here. This does no more than set off a “speculative chain of

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events,” Moms Against Mercury, 483 F.3d at 827, that might or

might not result in promulgation of a final regulation subject to

this court’s exclusive jurisdiction and as such does not give rise

to jurisdiction under TRAC. Indeed, if the FDA were to deny the

NRDC’s citizen petition, then “no part of the statutory food

additive petition process would be invoked and the denial would

be reviewable only in district court.” Respondent’s Br. 21. It is

true, as the NRDC points out, that in DiCola v. FDA, 77 F.3d

504 (D.C. Cir. 1996), the court suggested in the context of a

TRAC type action in which final review would necessarily be in

the courts of appeals, that if the petitioner submitted a citizen

petition and the FDA unreasonably delayed its response, then

the petitioner could file a mandamus petition in this court. See

id. at 509–10. But here, where judicial review of the FDA’s

final action on the NRDC’s citizen petition might be in the

district court, the TRAC exception does not apply. 

None of the NRDC’s other arguments that section 409 of

the Act governs the citizen petition process in section 10.30 of

the FDA regulations is any more persuasive. Contrary to the

NRDC’s claim, the FDA has not “concede[d] that other

provisions in [section 409] do apply to its consideration of

NRDC’s petition.” Reply Br. 5 (emphasis in the original). 

Rather, the FDA acknowledged that were it to determine that a

citizen petition warrants initiation of a rulemaking, then certain

provisions of section 409 would apply. See Respondent’s Br. 8,

20. This is but one of three possible responses to the filing of a

citizen petition, and other responses – denial or “tentative

response” – would not lead to a food additive regulation

established under section 409. See id. 20–21. There is no

inconsistency, much less concession by the FDA, between the

FDA’s acknowledgment that one possible response comes

within section 409 of the Act while others do not. 

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Neither is the FDA’s position that the NRDC was required

to submit a food additive petition in order to obtain exclusive

review in this court undercut by the NRDC’s claim that the food

additive petition seeks information only a food additive

manufacturer would have. The regulations provide that petitions

to amend food additive regulations “may omit statements made

in the original petition concerning which no change is

proposed.” 21 C.F.R. § 171.1(c). Under section 171.130(b), a

petitioner is to provide “an assertion of facts, supported by data,

showing that new information exists with respect to the food

additive or that new uses have been developed or old uses

abandoned, that new data are available as to toxicity of the

chemical, or that experience with the existing regulation or

exemption may justify its amendment or repeal,” but nothing

requires petitioners to provide information that only the

manufacturer would have.

Although this court has at times expressed the view that

“bifurcated jurisdiction between District Court and Court of

Appeals over identical litigation is not favored,” Environmental

Defense Fund v. Gorsuch, 713 F.2d 802, 813 (D.C. Cir. 1983)

(quoting Oljato Chapter of Navajo Tribe v. Train, 515 F.2d 654,

660 (D.C. Cir. 1975)), that concern is not implicated here,

contrary to the NRDC’s suggestion. The FDA’s regulations

require that new data presented with the aim of amending or

repealing a food additive regulation must be presented as a food

additive petition, 21 C.F.R. § 171.130(b), and, consequently,

exclusive jurisdiction over challenges relating to properly

submitted food additive petitions will be in the courts of appeals

pursuant to section 409(g) of the Act. The district courts will

have jurisdiction over citizen petitions that do not request repeal

or amendment of a food additive regulation based on new data.

So far as the NRDC elaborates that such a bifurcation creates a

conflict between the courts and “does not make sense,” Reply

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Br. 8, it fails to come to grips with the workings of the food

additive process under the regulations.

Finally, 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.

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

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exclusively reviewable in this court, we dismiss the petition for

lack of jurisdiction. 

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