United States District Court, N.D. California, Oakland Division
GEORGE A. KIMBRELL (Pro Hac Vice), PAIGE M. TOMASELLI State Bar No. 237737, RACHEL A. ZUBATY State Bar No. 240785, Center for Food Safety, San Francisco, CA, Counsel for Plaintiffs.
STUART F. DELERY, Assistant Attorney General, MAAME EWUSI-MENSAH FRIMPONG, Deputy Assistant Attorney General, MICHAEL S. BLUME, Director, Consumer Protection Branch, GERALD C. KELL, Senior Trial Counsel Consumer Protection Branch U.S. Department of Justice, Washington, DC, Counsel for Defendant
PHYLLIS J. HAMILTON, District Judge.
WHEREAS on January 4, 2011, Congress enacted the Food Safety Modernization Act (FSMA) to address the ongoing epidemic of foodborne illness in our country, which strikes one in six Americans annually;
WHEREAS Congress set deadlines for the Food and Drug Administration (FDA) to promulgate and finalize FSMA's implementing regulations, and FDA did not meet those deadlines;
WHEREAS Plaintiffs Center for Food Safety and Center for Environmental Health (Plaintiffs) filed this action on August 29, 2012, alleging that FDA had violated FSMA and the Administrative Procedure Act (APA) by unlawfully withholding the FSMA regulations beyond the required statutory deadlines, and seeking declaratory and injunctive relief requiring FDA to issue the regulations pursuant to a court-ordered timeline;
WHEREAS the Court granted Plaintiffs' Motion for Summary Judgment and denied FDA's Motion for Summary Judgment, and held that declaratory and injunctive relief were appropriate, see Ctr. for Food Safety v. Hamburg , No. C 12-4529 PJH, 2013 WL 1741816 (N.D. Cal. Apr. 22, 2013);
WHEREAS the Court acknowledged "FDA's showing of the complexity of the task, which involves making major modifications to procedures for food inspections and food handling, and its showing of diligence in attempting to discharge its statutory duty to promulgate regulations, " Ctr. for Food Safety v. Hamburg , No. C 12-4529 PJH (N.D. Cal. June 21, 2013);
WHEREAS the Court nevertheless crafted a close-ended timeline for completion of the FSMA regulations, Ctr. for Food Safety v. Hamburg , No. C 12-4529 PJH (N.D. Cal. June 21, 2013);
WHEREAS the Court subsequently denied FDA's motions for reconsideration and a stay pending appeal, Ctr. for Food Safety v. Hamburg , No. C 12-4529 PJH, 2013 WL 4396563, (N.D. Cal. Aug. 13, 2013) and Ctr. for Food Safety v. Hamburg , No. C 12-4529, 2013 WL 5718339 (N.D. Cal. Oct. 21, 2013);
WHEREAS FDA appealed the decision;
WHEREAS the Ninth Circuit's Motions Panel denied in pertinent part FDA's emergency motion for a stay pending appeal, Center for Food Safety v. Hamburg , No. 13-16841, (9th Cir. Nov. 4, 2013);
WHEREAS the Parties agree that resolution of this matter without further litigation is in the best interest of the Parties and the public, and that entry of this Consent Decree is the most appropriate means of resolving this action.
NOW, THEREFORE, upon consent of the Parties, and upon consideration of the mutual promises contained herein,
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:
I. GENERAL TERMS
1. This Consent Decree applies to, is binding upon, and inures to the benefit of the Parties (and their successors, assigns, and designees).
2. The Parties to this Consent Decree understand that Margaret Hamburg was sued in her official capacity as Commissioner of the United States Food and Drug Administration, and that obligations arising under this Consent Decree are to be performed by FDA and not Margaret Hamburg in her individual capacity.
3. Whenever terms listed below are used in this Consent Decree, the following definitions shall apply:
a. "Complaint" means the complaint filed in this case by the Center for Food Safety and the Center for Environmental Health on August 29, 2012 to initiate the lawsuit titled above.
b. "Consent Decree" means this document.
c. "FDA" means the United States Food and Drug Administration and/or the Defendant in this action, Margaret Hamburg, Commissioner of the United States Food and Drug Administration, or her duly authorized representative.
d. "Plaintiffs" means the Center for Food Safety and the Center for Environmental Health.
e. "Party" means either Plaintiffs or FDA.
f. "Parties" shall collectively refer to ...