United States District Court, D. Columbia.
[Copyrighted Material Omitted]
CENTER FOR FOOD SAFETY, Plaintiff: Peter T. Jenkins, LEAD
ATTORNEY, Center for Food Safety, Washington, DC; Cristina R.
Stella, Paige M. Tomaselli, PRO HAC VICE, CENTER FOR FOOD
SAFETY, San Francisco, CA.
SYLVIA M. BURWELL, Secretary of Health and Human Services,
STEPHEN OSTROFF, M.D., Acting Commissioner of Food and Drugs,
Defendants: Kerala Thie Cowart, LEAD ATTORNEY, U.S.
DEPARTMENT OF JUSTICE, Civil Division, Consumer Protection
Branch, Washington, DC.
Document No.: 17
CONTRERAS, United States District Judge.
Plaintiff'S Motion for Attorneys' Fees and
action, the Center for Food Safety (" CFS" ) seeks
from the U.S. Food and Drug Administration (" FDA"
), the Secretary of Health and Human Services, and the
Commissioner of Food and Drugs (collectively, the "
Defendants" ) an award of attorneys' fees and costs
incurred in litigating its claims under the Administrative
Procedure Act (" APA" ), see 5 U.S.C.
§ § 500 et seq. CFS contends that,
pursuant to the Equal Access to Justice Act, 28 U.S.C. §
2412(d)(1)(A), it is entitled to reasonable attorneys'
fees and costs because it was the " prevailing
party" in the litigation and because the Defendants'
position was not " substantially justified." The
Defendants dispute both contentions. Because the Court
concludes that the Defendants' position was substantially
justified, the Court denies CFS's motion for
attorneys' fees and costs.
1958, Congress enacted the Food Additives Amendment to the
Federal Food, Drug, and Cosmetic Act, see 21 U.S.C.
§ § 301 et seq. (" FFDCA" ),
requiring food manufacturers to submit to FDA evidence
demonstrating the safety of food additives before FDA
approves the additives for use in the marketplace. See
generally Substances Generally Recognized as Safe, 62
Fed.Reg. 18,938, 18,938-39 (proposed Apr. 17, 1997) (to be
codified at 21 C.F.R. § 170.36). Under this amendment,
" food additive" is defined to exclude substances
" generally recognized . . . to be safe under the
conditions of [their] intended use," which are often
referred to as " GRAS" substances. 21 U.S.C. §
321(s) (2009). Accordingly, if food manufacturers determine
independently that their substances are GRAS for a particular
use, they are permitted to bring these substances to the
marketplace without FDA's approval and without even
notifying FDA. See 62 Fed.Reg. at 18,939; Am. Compl.
7; Mem. Supp. Defs.' Mot. Dismiss 12. In the late
1960s, however, after new scientific information came to
light that cast doubt on a substance that FDA had previously
considered GRAS for its intended use, FDA promulgated
regulations establishing a " petition affirmation
process" by which food manufacturers could voluntarily
petition FDA for " official recognition" of their
substance's GRAS status. See 21 C.F.R. §
170.30-35; U.S. Gov't Accountability Office, GAO-10-246,
Food Safety: FDA Should Strengthen Its Oversight of Food
Ingredients Determined to Be Generally Recognized as Safe
(GRAS) 5 (2010) [hereinafter " GAO Report" ]; Am.
Compl. 7; Mem. Supp. Defs.' Mot. Dismiss 7. As part of
this voluntary process, food manufacturers would submit
scientific data as part of their initial petition.
See 21 C.F.R. § 170.35 (2011). FDA would then
proceed by comprehensively reviewing this scientific data,
publishing a notice in the Federal Register for comment, and
drafting an explanation of FDA's GRAS determination. GAO
Report at 5-6; Am. Compl. 8; Mem. Supp. Defs.' Mot.
1997, claiming that the previous GRAS " petition
affirmation process" was too cumbersome for both food
manufacturers and the agency, FDA issued a proposed rule (the
" Proposed Rule" ) changing this voluntary
procedure to permit food companies to merely "
notify" FDA of their GRAS determinations. See
62 Fed.Reg. at 18,938-41. Under the Proposed Rule, FDA no
longer conducts a comprehensive scientific investigation of
submitted data or " affirms" the GRAS status of a
substance. GAO Report at 6; Am. Compl. 9; Mem. Supp.
Defs.' Mot. Dismiss 9. Instead, once FDA reviews a
company's GRAS notice, it sends the company a letter with
one of three notifications: 1) FDA has " no
questions" about the company's independent GRAS
determination; 2) the company's GRAS notice does not
provide a sufficient basis for a GRAS determination; or 3)
FDA has ceased to evaluate the GRAS notice at the
company's request. GAO Report at 6. FDA stresses that
these letters are nonbinding and do not constitute a legal or
factual determination that a substance is or is not GRAS.
See Defs.' Resp. to Pl.'s Mot. Att'y
Fees 2, ECF No. 18.
Proposed Rule, FDA also announced an interim policy (the
" Interim Policy" ) permitting food manufacturers
to submit GRAS notices under the process described in the
Proposed Rule until FDA finalizes any rule based on the
proposal. See 62 Fed.Reg. at 18,954-55. Since 1997,
FDA has operated under the Interim Policy, though FDA has
sought comments during two different time periods.
See id. at 18,954; Substances Generally
Recognized as Safe, 75 Fed.Reg. 81,536, 81,536 (Dec. 28,
2010). FDA has neither responded to any of the comments nor
issued a final rule. See Am. Compl. 2; Mem. Supp.
Defs.' Mot. Dismiss 11-12.
February 2014, CFS brought this action against the
Defendants. See generally Compl. The amended
complaint alleged that FDA's failure to adopt a final
rule or respond to commenters after seventeen years "
deprive[s] the public of the vital procedural rights afforded
by the [APA]."  Am. Compl. 2. Because of the long
delay in finalizing the Proposed Rule and because FDA
currently operates under the Interim Policy, CFS argued that
the Proposed Rule " constitutes final agency action
within the meaning" of 5 U.S.C. § 704, and is thus
subject to judicial review.
Am. Compl. 22. After finding that FDA's action meets this
threshold test, the Court, CFS argued, should " hold
unlawful and set aside" the Proposed Rule under §
706(2)(A) as " arbitrary, capricious, an abuse of
discretion, or otherwise not in accordance with law,"
or, in the alternative, under § 706(2)(D) as "
without observance of procedure required by law."
Id.; see also 5 U.S.C. § 553(c) (requiring
agencies to " give interested parties an opportunity to
participate" in rulemaking). Accordingly, in its prayer
for relief, CFS requested that the Court vacate the Proposed
Rule and declare that the Defendants had violated and
continue to violate the APA " by failing to respond to
comments and properly promulgate a final GRAS rule." Am.
response, the Defendants filed a motion to dismiss, arguing
that CFS lacked standing to sue, that the Proposed Rule and
the Interim Policy are not final agency action and are thus
not subject to judicial review, and that CFS's challenge
was barred by the statute of limitations. See
generally Mem. Supp. Defs.' Mot. Dismiss. The
parties later agreed, however, that resolution of this matter
without further litigation was in their best interest.
See Consent Decree, ECF No. 15. Upon agreement
between CFS and the Defendants, the Court issued a Consent
Decree on October 20, 2014, requiring FDA to finalize the
Proposed Rule and submit the final rule to the Federal
Register for publication no later than August 31, 2016.
Id. at 2. The Court may grant FDA an extension of
this deadline only if 1) the Court obtains the written
consent of both CFS and FDA, or 2) FDA files a motion that
the Court finds successfully demonstrates " good cause
and/or exceptional circumstances warranting the
extension." Id. at 2-3. In that same Consent
Decree, CFS agreed to release all of its claims in the case.
Id. at 5.
before the Court is CFS's motion for attorneys' fees
and costs under the Equal Access to Justice Act. See
Pl.'s Mot. Att'y Fees, ECF No. 17. The motion is now
fully briefed and ripe for decision.