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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.
2
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
3
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).
4
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
5
“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
6
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
7
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 non-
statutory 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
8
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.
9
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
10
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.
11
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
12
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
13
exclusively reviewable in this court, we dismiss the petition for
lack of jurisdiction.