                           UNITED STATES DISTRICT COURT
                           FOR THE DISTRICT OF COLUMBIA



CENTER FOR SCIENCE IN THE
PUBLIC INTEREST, et al.,

       Plaintiffs,
               v.                                         Civil Action No. 14-375 (JEB)
UNITED STATES FOOD AND DRUG
ADMINISTRATION, et al.,

       Defendants.


                                 MEMORANDUM OPINION

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

                                                 1
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



                                                 2
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 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

                                                  3
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, ¶ 12. To address this issue, starting in approximately 2006, FDA

began developing a methodology for assessing the net effects of fish consumption on

neurodevelopment, and in January 2009, after obtaining peer review, issued the draft

recommendations for public comment. Id., ¶¶ 13, 18, 19.

       On June 10, 2014, FDA published its Final Assessment, entitled “Quantitative

Assessment of the Net Effects on Fetal Neurodevelopment from Eating Commercial Fish (As

Measured by IQ and also by Early Age Verbal Development in Children).” See id., ¶ 15; id.,

Exh. 1 (Final Assessment). At the same time, FDA and EPA issued a draft updating its 2004

Advisory – the same advisory Plaintiffs had petitioned to be included in seafood labeling – and

solicited public comment on these updated recommendations. See id., ¶ 25; id., Exh. 3 (Draft



                                                   4
Advisory). The Draft Advisory represents FDA’s proposed position on how to maximize the

benefits of seafood consumption for the Target Group and was influenced by the Final

Assessment. See id., ¶ 25. According to the Administration, the next step in finalizing this draft

comes when FDA’s Risk Communication Advisory Committee meets this month to discuss it.

Id., ¶ 27. Moving forward, the comment period will then remain open for 30 days after this or

any other subsequent public meetings. Id. Before publishing a final advisory, FDA will consider

any comments together with the view of the Advisory Committee, and it will confer with EPA

regarding any changes to the Draft Advisory. See id.; 79 Fed. Reg. at 33559-02. According to

the agency, finalizing the Draft Advisory “may require further analysis and significant policy

discussion.” Landa Decl., ¶ 27.

       D. This Suit

       Plaintiffs filed this lawsuit on March 10, 2014, seeking an order compelling FDA to

respond to their petition. They principally allege that FDA’s delay is unreasonable and therefore

merits judicial intervention. The parties now cross-move for summary judgment.

II.    Legal Standard

       Summary judgment may be granted if “the movant shows that there is no genuine dispute

as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.

56(a); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986); Holcomb v.

Powell, 433 F.3d 889, 895 (D.C. Cir. 2006). A fact is “material” if it is capable of affecting the

substantive outcome of the litigation. See Liberty Lobby, 477 U.S. at 248; Holcomb, 433 F.3d at

895. A dispute is “genuine” if the evidence is such that a reasonable jury could return a verdict

for the nonmoving party. See Scott v. Harris, 550 U.S. 372, 380 (2007); Liberty Lobby, 477

U.S. at 248; Holcomb, 433 F.3d at 895. “A party asserting that a fact cannot be or is genuinely



                                                 5
disputed must support the assertion” by “citing to particular parts of materials in the record” or

“showing that the materials cited do not establish the absence or presence of a genuine dispute,

or that an adverse party cannot produce admissible evidence to support the fact.” Fed. R. Civ. P.

56(c)(1). The moving party bears the burden of demonstrating the absence of a genuine issue of

material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).

       A motion for summary judgment must generally be “accompanied by a statement of

material facts as to which the moving party contends there is no genuine issue . . . .”

LCvR7(h)(1). An opposition, likewise, must “be accompanied by a separate concise statement

of genuine issues setting forth all material facts as to which it is contended there exists a genuine

issue necessary to be litigated . . . .” Id. Plaintiffs fault FDA for not including such a statement

in its Opposition. See Pl. Opp. & Rep. at 1 n.1. This requirement, however, does “not apply to

cases in which judicial review is based solely on the administrative record. In such cases,

motions for summary judgment and oppositions thereto shall include a statement of facts with

references to the administrative record.” LCvR7(h)(2). Because this case falls under the APA, it

can be fairly interpreted as one that does not require a separate statement of material facts. FDA,

moreover, has included a Declaration to support its Motion, and it does not dispute the facts

included in Plaintiffs’ Statement. See Def. Rep. at 1 n.1. The Court, therefore, has a record

adequate to rule on the opposing Motions.

III.   Analysis

       The APA requires an agency to “proceed to conclude a matter presented to it” within “a

reasonable time,” 5 U.S.C. § 555(b), and directs courts to “compel agency action . . .

unreasonably delayed.” Id. § 706(1). Together, “[t]hese provisions give courts authority to

review ongoing agency proceedings to ensure that they resolve the questions in issue within a



                                                  6
reasonable time.” Pub. Citizen Health Research Group v. Comm’r, Food & Drug Admin., 740

F.2d 21, 32 (D.C. Cir. 1984). Plaintiffs invoke this authority in seeking an order compelling

FDA to respond to their petition. “In the context of a claim of unreasonable delay,” the Court

must consider whether the agency’s failure to respond is “so egregious” as to warrant relief. See

Telecommunications Research & Action Ctr. v. FCC, 750 F.2d 70, 79 (D.C. Cir. 1984) (TRAC).

In making this assessment, moreover, the Court bears in mind “the limits of [its] institutional

competence in the highly technical area at issue in this case.” Grand Canyon Air Tour Coal. v.

FAA, 154 F.3d 455, 476 (D.C. Cir. 1998).

       In determining whether FDA’s delay has been unreasonable, the parties agree that this

case is governed by the “hexagonal contours of a standard” identified in TRAC, 750 F.2d at 80.

In that case, the D.C. Circuit identified the following six considerations as relevant in evaluating

agency delay:

                (1) the time agencies take to make decisions must be governed by a
                rule of reason; (2) where Congress has provided a timetable or
                other indication of the speed with which it expects the agency to
                proceed in the enabling statute, that statutory scheme may supply
                content for this rule of reason; (3) delays that might be reasonable
                in the sphere of economic regulation are less tolerable when human
                health and welfare are at stake; (4) the court should consider the
                effect of expediting delayed action on agency activities of a higher
                or competing priority; (5) the court should also take into account
                the nature and extent of the interests prejudiced by delay; and (6)
                the court need not find any impropriety lurking behind agency
                lassitude in order to hold that agency action is unreasonably
                delayed.

Id. (citations and quotation marks omitted).

       These considerations cohere into three basic inquiries in this case. First, is there any

rhyme or reason – congressionally prescribed or otherwise – for FDA’s delay (factors one and

two)? Second, what are the consequences of delay if the Court does not compel the



                                                 7
Administration to act (factors three and five)? Finally, how might forcing the agency to act

thwart its ability to address other priorities (factor four)? In what follows, the Court finds that

the answers to these questions counsel against intervention at this time.

       A. Reasonableness

       The first TRAC factor asks whether FDA’s timeline in responding is “governed by a ‘rule

of reason,’” and the second provides that the content of such a rule may be found in a “timetable

or other indication . . . in the enabling statute.” TRAC, 750 F.2d at 80. In other words, these

factors get at whether the agency’s response time complies with an existing specified schedule

and whether it is governed by an identifiable rationale. Plaintiffs contend that FDA’s delay in

this case violates both precepts. First, they claim that the Administration’s three-year delay does

not comport with a rule of reason, because – among other things – it is well beyond the agency’s

own regulatory timetable for responding to citizen petitions. Second, they point to a similar

petition that FDA did deny and surmise from this that the agency has long been equipped to

respond to Plaintiffs’ petition as well. Neither argument, however, shows that the time FDA has

taken to respond in this case approaches an egregious standard.

       First, Plaintiffs highlight the fact that FDA has 180 days to “[a]pprove,” “[d]eny,” or

“[p]rovide a tentative response, indicating why the agency has been unable to reach a decision on

[a citizen] petition.” 21 C.F.R. § 10.30(e)(2). While they acknowledge that the Administration

has technically complied with this regulation, they nonetheless argue that, beyond its literal

application, this deadline also provides a framework within which to gauge FDA’s delay in

issuing a final response. In other words, the timeliness of the agency’s ultimate action should be

scaled to this regulatory scheme – especially when health and welfare are at stake. Congress has,

after all, charged FDA with “promot[ing] the public health by promptly and efficiently reviewing



                                                  8
clinical research and taking appropriate action on the marketing of regulated products in a timely

manner . . . .” 21 U.S.C. § 393(b)(1) (emphases added). A delay of years in the face of a six-

month regulatory timeline, Plaintiffs conclude, is unreasonable.

       The Court is unpersuaded. To begin with, Plaintiffs’ allusion to the regulatory timetable

is a false trail. While these regulations give 180 days for a tentative response, they say nothing

about how long FDA has to issue an ultimate response to a citizen petition. The only applicable

standard against which to measure that action is the APA’s requirement that FDA act “within a

reasonable time.” 5 U.S.C. § 555(b). Upon reflection, this makes sense. Whether the

Administration has unreasonably delayed its response to a petition can only be measured by

reference to the complexity of the task. The more complex the petition, the more time an agency

may need to adequately respond. See Mashpee Wampanoag Tribal Council, Inc. v. Norton, 336

F.3d 1094, 1102 (D.C. Cir. 2003) (whether delay is unreasonable “cannot be decided in the

abstract, by reference to some number of months or years beyond which agency inaction is

presumed to be unlawful, but will depend in large part . . . upon the complexity of the task at

hand, the significance (and permanence) of the outcome, and the resources available to the

agency”). Courts, moreover, routinely defer to the judgment of agencies when assessing

timelines that involve complex scientific and technical questions. See, e.g., In re United Mine

Workers of Am. Int’l Union, 190 F.3d 545, 555 (D.C. Cir. 1999) (“[I]t is difficult for us to

second-guess” the agency’s time projections “in light of the host of complex scientific and

technical issues involved.”); Sierra Club v. Thomas, 828 F.2d 783, 798-99 (D.C. Cir. 1987)

(“EPA must be afforded the amount of time necessary to analyze” “complex scientific,

technological, and policy questions.”). In the present case, the Court lacks the competence to

ascertain how long it might take to measure the risks of mercury on childhood development, to



                                                 9
gauge the effects any regulations might have on mercury consumption, or to predict the benefits

or detriments that might occur if mercury warnings are placed where seafood is sold. These are

tasks for FDA.

       The Administration, in fact, appears to be busy trying to address these very concerns. At

the time Plaintiffs petitioned FDA to initiate a rulemaking, in part based on the 2004 Advisory,

the agency was in the process of evaluating its overall approach to mercury in seafood.

According to FDA, substantial evidence had emerged that fish consumption by pregnant women

and young children can improve neurodevelopment despite mercury intake. See Landa Decl., ¶

12. For this reason, starting in 2006, FDA began developing a methodology for assessing the net

effects of fish consumption on neurodevelopment. See id., ¶¶ 15, 25. The Administration has

now published its Final Assessment, and, in light of its conclusions, FDA and EPA have issued a

draft to replace the 2004 Advisory, which they are working to finalize. See id., ¶ 27. The

Administration has not responded to Plaintiffs’ petition, it explains, because it is waiting on the

content of the revised advisory. See Def. Rep. at 4.

       That explanation makes sense. It is perfectly understandable that FDA would want to

wait on the final content of its revised recommendations before determining what point-of-sales

labeling might be required by law. Until this advice is finalized, FDA is not in a position to

determine what the content of any such recommendations might be. Contrary to Plaintiffs’

contentions, moreover, see Pl. Opp. & Rep. at 10, even at this stage, the Draft Advisory includes

small but possibly significant changes to the FDA’s approach to optimizing the benefits of

seafood consumption for the Target Group. As FDA points out, the 2004 Advisory recommends

against eating more than twelve ounces of low-mercury fish each week, but does not recommend

a minimum amount. See 2004 Advisory at 1. The Draft Advisory, on the other hand, suggests



                                                 10
eating at least eight ounces of fish in this category each week. See Draft Advisory. It would be

imprudent, FDA reasonably explains, to act on a petition requesting mandatory labeling based on

outdated advice when new advice is nearing completion.

       Plaintiffs, however, are not done. To support their position, they invoke the decision in

Muwekma Tribe v. Babbitt, 133 F. Supp. 2d 30 (D.D.C. 2000). In that case, too, there was no

“preemptory requirement in [the enabling] statute, regulations or guidelines that would require

[agency action] . . . within any predetermined time frame.” See id. at 38-39. The court

nonetheless concluded that Congress did not intend requests for agency action to “languish . . .

indefinitely.” Id. Plaintiffs urge that the Administration’s vague “hope” that it will complete its

review “in the near future” is exactly the kind of indefinite non-response considered

unreasonable in that case. See id. at 37 (agency’s “noncommittal estimate” for completing

review of petition supported finding of unreasonable delay).

       Plaintiffs’ reliance on Muwekma is misplaced. That case centered on a Native American

tribe’s petition for federal recognition. See id. at 31-32, 38. The tribe spent six years dealing

with the Bureau of Indian Affairs before its petition was considered “filed” and three more trying

to make its way onto a list of cases “ready for active consideration.” Id. at 36. Over a year after

finding out it had been placed on that list, the tribe learned it would take up to four more years

before the appropriate branch of the BIA would begin considering its petition. See id. at 37. The

court in that case found that the agency’s “noncommittal estimate coupled with the specific

history of interaction between th[e] parties [gave] rise to a finding of ‘unreasonable delay.’” Id.

In addition, the record there did not “support the notion that resources [were] being dispatched in

a manner consistent with mitigating unreasonable delay.” Id. at 40. Here, in contrast, FDA has

been at work reviewing the relevant scientific issues, has progressed in that work – evidenced by



                                                 11
the Final Assessment and Draft Advisory – and has done so in the context of a complex scientific

inquiry. Its explanation for delay also provides a general horizon over which it will be able to

act on Plaintiffs’ petition – namely, once it has finalized its Draft Advisory. This is not the kind

of egregious and unexplained delay that merits intervention.

        Plaintiffs’ second argument fares no better. They point to a petition involving similar

issues that FDA did respond to as evidence that the agency has been in a position to respond to

Plaintiffs’ petition for some time. The other petition was filed by GotMercury.org, a project of

the Turtle Island Restoration Network, and the Center for Biological Diversity. See Kupau-Odo

Decl., Exh. 11 (CBD Petition). Like Plaintiffs’, the CBD Petition requested that FDA “[r]equire

seafood distributors, retailers, restaurants and all institutions that sell seafood to post the [2004

Advisory] at ‘point-of-sale’ locations and/or label fish products that are known to be high in

mercury.” Id. at 3. Unlike its tentative response to Plaintiffs’ petition, however, the

Administration denied this one, concluding that it had “not provide[d] FDA with a basis to make

a determination that the information [it had] Request[ed] be included in the labeling of

commercial fish [was] ‘material’ with[in] the meaning of . . . the [FDCA].” See Kupau-Odo

Decl., Exh. 12 (CBD Denial Letter) at 17. According to Plaintiffs, the denial of what they

consider a substantially identical petition demonstrates that FDA has long had any and all

resources it might need to act on their request. If the Administration could deny the CBD

Petition, Plaintiffs conclude, it could deny theirs. See In re Am. Rivers & Idaho Rivers United,

372 F.3d 413, 420 (D.C. Cir. 2004) (noting an agency’s delay “uncharacteristic of the relatively

swift treatment it routinely gives similar petitions”).

        Plaintiffs’ contention, however, overlooks the significant differences between the

petitions. True, the CBD Petition included a request that the 2004 Advisory be posted where



                                                  12
seafood is sold, but this was a minor inclusion in a petition that dealt primarily with lowering

regulatory thresholds for mercury in seafood to 0.5 parts per million. See CBD Petition at 3.

Relatively little of the CBD Petition was dedicated to the issue of labeling, and in response to the

sparse support this request cited, FDA determined that the petition had “provide[d] no basis upon

which to conclude” that the 2004 Advisory “constitutes a ‘material fact’ with respect to

commercial fish,” such that nondisclosure would render labeling “false or misleading.” CBD

Denial Letter at 17.

       Plaintiffs’ petition, in contrast, was fully dedicated to point-of-sale labeling. Their

arguments dug deeper and reached more broadly than those found in the CBD petition. Plaintiffs

devoted pages to the issue of FDA’s legal authority to require the requested labeling and

provided the Administration with several alternative bases for their proposed action. See

Plaintiffs’ Petition at 19-34. These differences sufficiently answer Plaintiffs’ allegations of

inconsistent treatment. In other words, FDA’s rationale in denying the CBD Petition was that

petitioners there had not provided a basis for FDA to act. This response says nothing of whether

Plaintiffs here have done so. At bottom, FDA may deny a summary request like that found in the

CBD Petition yet refuse to act on a more developed request because the agency must conduct

further research to evaluate claims in the latter that were not forwarded in the former.

       Plaintiffs’ petition, moreover, went well beyond merely disseminating the 2004

Advisory. They requested several sets of labels, the inclusion of consumption recommendations

for seafood not otherwise listed in the 2004 Advisory, and the placement of placards near

unpackaged fish. See Plaintiffs’ Petition at 5-6. It is hardly a stretch that, as to these more

detailed requests, FDA would need to rely upon the conclusions of the Final Assessment and

potentially incorporate the language of the Draft Advisory in responding. See Def. Rep. at 7.



                                                 13
After all, the agency must draw both scientific and policy conclusions in deciding exactly what

action to take on Plaintiffs’ petition.

          In sum, FDA is addressing the mercury issue and will soon publish updated advice for the

Target Group on how best to consume seafood. It is not unreasonable for the agency to wait for

the results of this regulatory action before acting on Plaintiffs’ petition, which seeks

dissemination of that very advice. TRAC factors one and two, therefore, weigh against issuing

relief.

          B. Effects of Delay

          The third and fifth factors identified in TRAC run together in this case. The third looks

to whether “human health and welfare are at stake” – in which case compulsion is more justified

– and the fifth assesses the “nature and extent of the interests prejudiced by delay.” See 750 F.2d

at 80. Because Plaintiffs seek to compel FDA action principally out of a desire to protect human

health and welfare, the consequence of inaction for Plaintiffs and the public are one and the

same.

          Plaintiffs’ argument on this front makes sense. FDA admits that mercury is toxic, that

the young are the most susceptible to its effects, and that exposure to mercury can be reduced by

eating fish lower in mercury. Those at risk, however, can limit mercury exposure only if they

know how – yet many do not. See Pl. Opp. & Rep. at 6-9. Without a final response, Plaintiffs

are unable to alert this population to the risks of mercury either through FDA action or a court

order. See Pl. Mot. at 13-15. Plaintiffs conclude, therefore, that because FDA’s inaction

threatens health and welfare, it is unreasonable. See Pub. Citizen, 740 F.2d at 34 (evidence

suggested unreasonably dilatory decisionmaking where “[a]ll scientific evidence in the record

point[ed] to a link between salicylates and Reye’s Syndrome”); Pub. Citizen v. Heckler, 602 F.



                                                  14
Supp. 611, 612 (D.D.C. 1985) (ordering action where agency admitted in lawsuit “that the

consumption of certified raw milk [was] linked to the outbreak of serious disease” yet still had

not acted) (quotation marks, citations, and alterations omitted); Pub. Citizen Health Research

Grp. v. Auchter, 702 F.2d 1150, 1157 (D.C. Cir. 1983) (“Three years from announced intent to

regulate to final rule is simply too long given the significant risk of grave danger [ethylene

oxide] poses to the lives of current workers and the lives and well-being of their offspring.”).

        FDA counters that public safety is its raison d’être; its entire docket involves issues of

“human health and welfare.” TRAC, 750 F.2d at 80. The agency, consequently, constantly

faces difficult questions relating to food contamination, nutritional information, and epidemics.

See Def. Mot. & Opp. at 23. Because everything the Administration does involves health and

welfare, it contends, the fact that Plaintiffs’ petition also implicates these concerns is far less

significant than it might otherwise be. This is correct. As the D.C. Circuit has noted,

“[A]lthough this court has required greater agency promptness as to actions involving interests

relating to human health and welfare, . . . this factor alone can hardly be considered dispositive

when, as in this case, virtually the entire docket of the agency involves issues of this type.”

Thomas, 828 F.2d at 798.

        FDA also emphasizes the evidence that fish consumption may in fact be more beneficial

than harmful for the Target Group. Uncertainty on the exact balance of risk to reward in seafood

consumption distinguishes this case from those relied upon by Plaintiffs, where no one disputed

the dangers at issue. See Pub. Citizen, 740 F.2d at 34 (“All scientific evidence in the record

points to a link between salicylates and Reye’s Syndrome . . . .”); Heckler, 602 F. Supp. at 613

(“Officials at the highest levels of [the agency] have concluded that certified raw milk poses a

serious threat to the public health.”); Auchter, 702 F.2d at 1157 (noting the “[a]mple evidence in



                                                  15
the record indicat[ing] a significant risk that some workers, who [were] actually being exposed to

levels of [ethylene oxide] greater than the 10 ppm ‘average’” encountered “a potentially grave

danger to both their health and the health of their progeny”). The risk analysis here, on the other

hand, is made complex by the countervailing benefits of seafood consumption. In fact, FDA’s

Final Assessment estimates that for the vast majority of commercial fish, average or above

consumption levels will likely result in net benefits for fetal development. See Final Assessment

at 104-07. Based on these considerations, the Court is persuaded that the action FDA has

delayed here – namely, approving or denying Plaintiffs’ request – does not carry with it the

certain danger involved in the cases upon which Plaintiffs rely.

        The Court thus finds that TRAC factors three and five run against Plaintiffs.

        C. Competing Priorities

        Finally, the Court considers “the effect of expediting delayed action on agency activities

of a higher or competing priority.” TRAC, 750 F.2d at 80 (fourth factor). Plaintiffs’ central

argument here is that mercury in seafood is a high-priority action for FDA, and there is thus no

reason it cannot address their petition. The Administration, by its own admission, is “currently

evaluating whether it should promulgate regulations to require that consumers be provided with

additional information regarding mercury in fish and shellfish.” Pl. Mot. at 14 (citing Ans., ¶¶

16, 19, 52). Nothing stands in the way of addressing this priority, Plaintiffs maintain, because

the Final Assessment and Draft Advisory support, without qualification, FDA’s longstanding

conclusion that women and children should choose lower-mercury fish. Id. at 12-13. Plaintiffs

conclude, therefore, that acting on their request will do nothing to jeopardize FDA’s other

actions in this high-priority area.




                                                16
       In response, the Administration acknowledges that mercury is a high priority for the

agency. It explains, however, that rushing a decision on Plaintiffs’ detailed labeling

recommendations at this juncture would force it to take action without due deliberation and

would thereby draw resources from actually resolving issues related to mercury consumption.

See Def. Mot. & Opp. at 27. Again, the Court finds this a sensible reason to wait in responding,

considering that Plaintiffs’ petition seeks to disseminate recommendations that are in the process

of revision. The Court also notes that, by virtue of its very mission, FDA routinely faces

daunting decisions about how to prioritize safety initiatives. Recent issues the agency has

addressed include safety-oversight regulation in an increasingly globalized food industry,

implementation of a new regulatory framework for infant formula, and upgrades to nutrition

panels. See Landa Decl., ¶¶ 31-33. Due to its expertise, the Administration must be permitted

flexibility in navigating the tough choices that come along with its expansive safety docket. See

Sierra Club, 828 F.2d at 798 (noting EPA’s “very broad mandate” but “finite resources”). The

Court will, therefore, not second-guess FDA’s “unique – and authoritative – position to view its

projects as a whole, estimate the prospects for each, and allocate its resources in the optimal

way.” See In re Barr Laboratories, Inc., 930 F.2d 72, 76 (D.C. Cir. 1991) (refusing mandamus

relief even where FDA had violated a statutory deadline, because so doing, although beneficial to

the plaintiff, would likely impose offsetting burdens on other parties equally worthy of agency

action). The fourth TRAC factor, accordingly, gives the Court further reason not to intervene.

                                         *       *       *

       In conclusion, the Court finds that – given FDA’s contemporaneous efforts to address

mercury in seafood and because the agency has provided a general endpoint in the future at

which time it will be equipped to act on Plaintiffs’ petition – the agency’s delay does not warrant



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judicial intervention at this juncture. This calculus may change, of course, once FDA and EPA

finalize what is now their Draft Advisory on seafood consumption. At some point thereafter,

further delay could well become unreasonable. The Court will not provide a precise timeline for

action now, but it does urge FDA to act with alacrity once the task it has identified is completed.

IV.    Conclusion

       For the foregoing reasons, the Court will grant Defendants’ Motion for Summary

Judgment and deny Plaintiffs’. A separate Order so stating will issue this day.



                                                     /s/ James E. Boasberg
                                                     JAMES E. BOASBERG
                                                     United States District Judge
Date: November 21, 2014




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