Is 10 Years (or 37 years) Unreasonable Enough?

CSPI Brings an APA Action to Force FDA to Issue a Decision on Salt’s GRAS Status

Update: On December 16, 2015, FDA filed an unopposed motion for an extension of response date to CSPI’s complaint. Included in the motion are two important pieces of information: first, FDA states that it will aim to provide a substantive response to CSPI’s citizen petition submitted in 2005 by January 27, 2016. Second, if the agency cannot meet the deadline due to “unforeseen circumstances,” then it will file a response to CSPI’s complaint by February 12, 2016. It seems likely that FDA is preparing an actual response to the citizen petition, and that the case may become moot (or at least, no longer based on an unreasonable delay claim). Courts typically do not deny an unopposed motion, and the case is likely to proceed according to FDA’s proposed schedule. We will continue to closely track this case, and provide updates as needed.

On October 8, 2015, a prominent consumer group (Center for Science in the Public Interest – “CSPI”) known for its active participation in food-related issues brought a lawsuit in the District Court for the District of Columbia, asking the Court to order FDA to issue a decision on CSPI’s 2005 citizen petition regarding salt’s GRAS status.[1]

CSPI is a consumer group that focuses on “educat[ing] the public, advocat[ing] government policies that are consistent with scientific evidence . . . and counter[ing] industry’s powerful influence on public opinion and public policies.” The group has previously filed numerous citizen petitions to FDA on behalf of its members, requesting that FDA limit the amount of added sugars (including high fructose corn syrup) in beverages[2] and more strictly regulate the sale of caffeine-containing dietary supplements.[3]

In addition to the above efforts, for the past 30 years, CSPI has been requesting that FDA promulgate rules limiting sodium in foods – the subject of the current litigation. The history of this case dates back more than three decades, and is the second district court case to be brought by CSPI regarding FDA’s non-decision on the sodium issue. Below is a short summary of the case’s long history, and our brief comments on the case’s disposition.

Facts

In 1978, CSPI filed its first petition to FDA, requesting that the agency re-classify salt as a food additive, set salt tolerance in foods, and require sodium labeling on pre-packaged foods. In 1982, the agency announced that instead of re-classifying, it would give industry the opportunity to reduce salt voluntarily, and would consider additional regulatory action regarding salt only if that effort was unsuccessful.

CSPI challenged the agency’s deferral by suing the agency in 1983 in the D.C. District Court. However, the Court dismissed the lawsuit, holding that FDA had a rational basis for deferring its decision on salt’s GRAS status. In 2005, CSPI filed a mandamus action in D.C. Circuit to force FDA to make a decision. The appeals court dismissed the case on the basis that CSPI must first seek a remedy directly from the agency.[4]

After the dismissal, CSPI submitted another citizen petition to FDA, asserting that FDA must act as FDA’s hope for industry’s voluntary compliance had not been realized. FDA held a public hearing in 2007, and sought additional information in 2011 on this issue – however, the agency still has not issued a final decision.

Current Proceeding

Similar to the 1983 and 2005 lawsuits, the October 2015 APA lawsuit[5] requests the Court to hold that FDA has unreasonably delayed its decision on CSPI’s citizen petition, and to force FDA to make a decision on salt’s GRAS status.  Since 1978, CSPI has been requesting FDA’s action, and the consumer group has been building an administrative record for over 30 years. The current suit is a continuation of the consumer group’s prior attempts to get the agency to act.

But how will the D.C. District Court rule?  On its face, this seems like an easy case. A person may bring an APA action for unreasonable delay when an agency decision is required under the law (not committed to agency discretion by law);[6] FDA is bound under its own regulations to rule on citizen petitions within 180 days of receiving them;[7] section 706(1) says a court must compel an agency action if unreasonably delayed; certainly, a much longer time period than 180 days has passed since CSPI submitted its petition; therefore, after 37 years (or 10 years since the last petition), CSPI is entitled to FDA’s immediate decision on its petition – right?

Unfortunately, it is not so simple. The factors courts consider when deciding whether to compel an agency action in unreasonable delay cases, and courts’ general reluctance in forcing an agency action, make the disposition more difficult to predict.

Relevant Factors 

In an unreasonable delay case, a court will consider several factors to determine whether the delay is unreasonable.[8] The court is not, however, required to give certain weight to a particular factor; rather, this is a balancing test to be conducted on a case-by-case basis.

In Telecommunications Research and Action Center (TRAC) v. Federal Communications Commission, the issue was whether FCC had committed unreasonable delay by failing to make a determination for five years on whether AT&T had collected excessive rates of return (i.e., profits) on long distance telephone calls.[9] Plaintiffs had submitted a petition in 1979 requesting agency review, after which FCC issued a Notice of Inquiry. However, after five years following the Notice, the agency did not issue a final decision. The agency during this time also missed its self-declared deadlines for resolving this matter.

The TRAC court held that compelling FCC’s action was unnecessary because during the litigation, FCC “assured [the Court] that it is now moving expeditiously to resolve the pending overcharge claims.” There had been prior cases in which the D.C. Circuit had held delays shorter than one in TRAC to be unreasonable, and compelled an agency to act. Here, however, the Court found the FCC’s statement assuring the Court of the matter’s resolution to be sufficient, and that no compelled action was necessary.

In doing so, the Court provided several factors that future courts may consider when determining whether an unreasonable delay had occurred.[10] The TRAC court did not consider these factors because in the Court’s view, FCC’s assurance of timely resolution made application of the factors unnecessary. However, a review of these factors may shed some light on how the District Court will view the current CSPI case.

Under TRAC jurisprudence, first, a court in an unreasonable delay case should consider Congress’s desired expediency regarding the specific agency action. In particular, statutory deadlines are good indicators for Congressional expectation on expediency.[11] Second, a court should consider delays in health and human welfare regulation to be graver and requiring more immediate agency action than delays in economic regulation. Third, a court should consider the nature and extent of interests prejudiced by the delay. Fourth, a court should consider the impact of compelling an agency action on the agency’s own priorities.

Here, considering these factors and the TRAC court’s decision, the District Court reviewing CSPI’s petition may determine that compelling FDA’s action is not necessary.

First, there is no statutory indication provided by Congress on how soon an agency should rule on a citizen petition. The 180-day limitation outlined for citizen petitions is a self-imposed deadline FDA promulgated through regulations.[12] The FCC in TRAC had also missed its own self-declared deadlines; nonetheless, the TRAC court declined to compel FCC to act. FDA’s non-adherence to its own deadline will not necessarily lead a reviewing court to conclude that compelling an agency action is needed.

Second, that FDA has not taken any action since its 2011 call for further information on salt’s health effect does not necessarily mean there has been an unreasonable delay. The D.C. Circuit has previously noted that there is no per se rule for determining whether a delay is “unreasonable.”[13] In fact, FCC in TRAC had also not taken an action for five years; despite this, the Court did not compel the agency to act.[14]

Of course, salt regulation’s effect on health and human welfare and the fact that a high salt consumption level can affect public health negatively may result in the Court deciding in CSPI’s favor. Generally, however, courts are reluctant to compel an agency action because of judicial respect for an agency’s allocation of its own resources. While the case for unreasonable delay here is strong, the District Court may decide the balancing test favors letting the FDA continue on its own course.

So What Will the Court Do? 

Compelling an agency action is not necessarily warranted in this case because courts are reluctant to force agency actions, and they can choose from many remedies even when the courts determine there has been an unreasonable delay. These remedies range from compelling an agency to take an immediate action, to setting a deadline for the agency, to permitting the agency to set its own deadline.

Here, the CSPI Court may simply let FDA set its own schedule (as long as FDA’s schedule is reasonable), and perhaps retain the case under the Court’s jurisdiction. If so, FDA would still not be under much pressure to immediately complete its review of CSPI’s petition. Additionally, FDA can simply decide to issue a tentative response stating that its resources are currently limited; such a response would meet 21 C.F.R. 10.30(e)(1)’s response requirement. In short, even if the Court decides there has been unreasonable delay, it may take years for FDA to rule in CSPI’s petition.

Predicting the disposition of an APA unreasonable delay lawsuit is particularly difficult because courts rely on a balancing test. Courts consider and balance several factors, and one court may give more weight to a particular factor than another court. Even within the D.C. District Court, disposition of a case may differ depending on which district judge is presiding over the case, and which factor the judge decides to emphasize.

Regardless, whatever the outcome of the case, another interesting fight on merits is bound to follow the Court and FDA’s decision – whether salt should remain GRAS. The Court here will not issue a decision on the merits.  That fight will be left for another day.  After all, we can’t have all the fun in one day.

 

 

[1] Center for Science in the Public Interest v. FDA, 1:15-cv-01651-BAH (D.D.C. Oct. 8, 2015). We note that CSPI could have taken an alternative approach by submitting a food additive petition permitted under Section 409 of the Food, Drug, and Cosmetic Act (FDCA). Remedies for the agency’s non-action on a food additive petition, and procedural routes for seeking the remedy will differ between a food additive petition and a citizen petition based on 21 C.F.R. 10.30.

[2] https://cspinet.org/new/pdf/sugar_petition_2-12-13_final.pdf

[3] http://cspinet.org/new/Caffeine-petition-CSPI-12-9-2014.pdf

[4] See 5 U.S.C. § 704.

[5] See 5 U.S.C. §§ 702, 706. Section 702 of Administrative Procedure Act removes sovereign immunity, and grants any person the right to sue the government and seek remedies (other than monetary) if the person has suffered harm from an agency action. Section 706 specifically permits courts to compel an agency action, if the agency has unlawfully withheld or unreasonably delayed an agency action.

[6] See Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55 (2004); see 5 U.S.C. § 701(a)(2).

[7] 21 C.F.R. § 10.30.

[8] See Telecommunications Research & Action Center v. Federal Communications Commission, 750 F.2d 70 (1984).

[9] Such practice would have violated FCC’s regulations that capped rates of return on long-distance and international calls to 9.5 percent, with further 0.5 percent permitted for encouraging productivity and efficiency.

[10] See TRAC (“Because, in the instant case, the FCC has assured us that it is moving expeditiously on both overcharge claims, we need not test the delay here against the above standard to determine if it is egregious enough to warrant mandamus”).

[11] Some decisions from the Tenth Circuit have held that missing a statutory deadline precludes consideration of these factors. However, D.C. Circuit decisions (controlling in this case and many other APA cases) have held that missing a statutory deadline is still just one factor to be considered when deciding whether to compel an agency action.

[12] See 21 C.F.R. § 10.30; Statutory basis exists for other types of petitions such as ones based on section 409 (food additive petition), or 505(q) of FDCA (specifically for drug approvals). However, no such statutory basis exists for the general type citizen petition. See In Re Natural Resources Defense Council, 645 F.3d 400 (D.C. Cir. 2011) (“The FDA adopts this position in its Response to the Petition, maintaining that the citizen petition procedure is non-statutory . . .”) (emphasis added).

[13] In re International Chemical Workers Union, et al., 958 F.2d 1144 (D.C.Cir. 1992) (“Although there is no per se rule as to how long is too long, ‘inordinate agency delay would frustrate congressional intent by forcing a breakdown of regulatory processes’”) (emphasis added).

[14] Timelines alone are not reliable indicators for predicting whether a reviewing court will consider a delay to unreasonable. Court decisions vary widely on how long is too long; courts have held a ten-year delay to be reasonable, while an eight-year delay was held to be unreasonable.

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