Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 1 of 11
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`GEORGE A. KIMBRELL (Pro Hac Vice)
`RYAN D. TALBOTT (Pro Hac Vice)
`Center for Food Safety
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`Emails: gkimbrell@centerforfoodsafety.org
` rtalbott@centerforfoodsafety.org
`
`Counsel for Plaintiffs
`
`DANIEL K. CRANE-HIRSCH
`Trial Attorney
`Consumer Protection Branch
`U.S. Department of Justice, Civil Division
`PO Box 386
`Washington, DC 20044-0386
`Telephone: 202-616-8242
`Fax: 202-514-8742
`daniel.crane-hirsch@usdoj.gov
`
`Counsel for Defendants
`
`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
`
`Case No.: 4:18-cv-06299-YGR
`
`CONSENT DECREE
`
`CENTER FOR FOOD SAFETY and CENTER
`FOR ENVIRONMENTAL HEALTH,
`Plaintiffs,
`v.
`ALEX M. AZAR II, SECRETARY OF U.S.
`DEPARTMENT OF HEALTH AND HUMAN
`SERVICES; NORMAN E. SHARPLESS, M.D.,
`ACTING COMMISSIONER OF FOOD AND
`DRUGS;1 and U.S. DEPARTMENT OF
`HEALTH AND HUMAN SERVICES,
`Defendants.
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`1 Norman E. Sharpless, M.D. became Acting Commissioner of Food and Drugs on April
`5, 2019. By operation of Fed. R. Civ. P. 25(d), Dr. Sharpless is automatically substituted as a
`party for former Commissioner of Food and Drugs, Scott Gottlieb, M.D.
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 2 of 11
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`WHEREAS, this case comes before the Court upon the Joint Stipulation for Entry of
`Consent Decree (“Stipulation”) of Plaintiffs Center for Food Safety and Center for
`Environmental Health and Defendants Alex M. Azar II, Secretary of U.S. Department of Health
`and Human Services; Norman E. Sharpless, M.D., Acting Commissioner of Food and Drugs; and
`U.S. Department of Health and Human Services. Plaintiffs and Defendants are collectively
`referred to as the “Parties.”
`WHEREAS on January 4, 2011, Congress enacted the Food Safety Modernization Act,
`Pub. L. No. 111-353, 124 Stat. 3885 (2011) (FSMA). This statute set deadlines for the Food and
`Drug Administration (FDA) to (1) designate high-risk foods for which additional recordkeeping
`requirements are appropriate and necessary to protect the public health (Section 204(d)(2)(A) of
`FSMA), and (2) publish a notice of proposed rulemaking to establish recordkeeping
`requirements for facilities that manufacture, process, pack, or hold such foods (Section 204(d)(1)
`of FSMA). This statute also required FDA to publish the list of the foods designated as high-risk
`on the FDA’s website at the time the agency promulgates the final rule establishing
`recordkeeping requirements for facilities that manufacture, process, pack, or hold high-risk foods
`(Section 204(d)(2)(B) of FSMA). Plaintiffs filed this action on October 15, 2018, alleging that
`FDA violated FSMA and the Administrative Procedure Act (APA) by failing to meet the
`statutory deadlines and to complete the other actions identified in the previous two sentences,
`and seeking declaratory and injunctive relief requiring FDA to take the actions described in the
`statute pursuant to a court-ordered timeline;
`WHEREAS Defendants neither admit nor deny the allegations in the Complaint;
`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:
`
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 3 of 11
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`I.
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`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 Alex M. Azar II and Norman E.
`Sharpless, M.D., were sued in their official capacities as Secretary of the United States
`Department of Health and Human Services (HHS), and Acting Commissioner of Food and
`Drugs, respectively, and that obligations arising under this Consent Decree are to be performed
`by HHS and FDA, and not Alex M. Azar II or Norman E. Sharpless, M.D. in their individual
`capacities.
`
`II.
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`DEFINITIONS
`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 October 15, 2018, to initiate this case.
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`b. “Consent Decree” means this document.
`
`c. “FDA” means the United States Food and Drug Administration and/or Defendant in
`this action, Norman E. Sharpless, M.D., Acting Commissioner of Food and Drugs, or
`his duly authorized representative.
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`d. “HHS” means Defendant in this action, the United States Department of Health and
`Human Services and/or Defendant in this action, Alex M. Azar II, Secretary of the
`United States Department of Health and Human Services, or his duly authorized
`representative.
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`e. “Plaintiffs” means the Center for Food Safety and the Center for Environmental
`Health.
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`f. “Party” means either Plaintiffs or Defendants.
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`g. “Parties” shall collectively refer to Plaintiffs and Defendants.
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`III.
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`SCHEDULE FOR FDA ACTION
`4. The Parties agree to the following schedule for FDA action. Except as otherwise
`specified below, the dates provided are dates by which FDA will submit documents to the Office
`
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 4 of 11
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`of the Federal Register for publication, rather than the dates by which the documents will be
`published.
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`a. Designation of the list of high-risk foods required by FSMA Section 204(d)(2)(A)
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`September 8, 2020
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`b. Recordkeeping requirements for the designated high-risk foods as required by FSMA
`Section 204(d)(1)
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`Proposed rule: September 8, 2020
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`Final rule: November 7, 2022
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`c. Publication on the FDA website of the list of high-risk foods required by FSMA
`Section 204(d)(2)(B)
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`Upon publication of the Final rule in the Federal Register
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`IV.
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`SEEKING EXTENSIONS AND FAILURE TO COMPLY WITH SCHEDULE
`5. FDA agrees in good faith to complete the actions in the above schedule and shall
`make every effort to meet or precede these dates. Nothing in this Consent Decree shall be
`construed as precluding FDA from satisfying the above schedule by dates earlier than those set
`forth in this document.
`6. If despite FDA’s best efforts (meaning commitment of agency time, money, energy,
`and resources that FDA reasonably anticipates will result in meeting the schedule in this Consent
`Decree), FDA believes good cause exists to seek an extension of the schedule, any date in the
`schedule set forth above may be extended by written agreement of the Parties and notice to the
`Court. The Parties agree to negotiate in good faith to reach a mutually agreeable outcome with
`respect to any such extension of the schedule, as the circumstances may warrant.
`7. In the unlikely event that FDA believes an extension of the schedule set forth in this
`Consent Decree is necessary and the Parties are unable to agree to the terms of the extension, as
`a measure of last resort FDA may seek modification of the schedule in accordance with the
`procedure specified below.
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`a. FDA shall file a motion requesting modification of any date established by this
`Consent Decree at least thirty days before the date at issue. In such a motion, FDA
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 5 of 11
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`shall have the burden to show good cause and/or exceptional circumstances
`warranting the delay, and address the effect of the delay on the public health and
`safety, among other relevant considerations. Any motion to modify the schedule
`established in this Consent Decree shall be accompanied by a motion for expedited
`consideration. In the event that circumstances arise less than thirty days before the
`specific deadline that make compliance with that deadline unfeasible, FDA may move
`to shorten the time required by this paragraph and shall have the burden to show good
`cause and/or exceptional circumstances warranting the shortened time.
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`b. FDA shall provide notice to Plaintiffs of its intent to file a motion to modify any date
`established by this Consent Decree as soon as reasonably possible, and in any event
`no later than a week prior to the filing of its motion unless good cause and/or
`exceptional circumstances warrant a shortened notice period.
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`c. FDA bears the burden of demonstrating that modification of the schedule is
`warranted.
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`8. In the event that FDA has failed to meet the schedule established in this Consent
`Decree, Plaintiffs’ first remedy shall be a motion to enforce the terms of this Consent Decree.
`FDA retains all rights to defend against such a motion.
`
`V.
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`DISPUTE RESOLUTION AND MODIFICATIONS
`9. In the event of a disagreement among the Parties concerning the interpretation or
`performance of any aspect of this Consent Decree including compliance with the schedule as
`explained above, the dissatisfied Party shall provide the other Party or Parties with written notice
`of the dispute and a request for negotiations. The Parties shall confer within twenty-one days of
`the written notice, or such time thereafter as is mutually agreed, in order to attempt to resolve the
`dispute. In the event that the Parties are unable to resolve the dispute, a Party may file with the
`Court a motion to enforce the Agreement and/or to compel performance, or a motion to modify
`this Agreement in accordance with Federal Rule of Civil Procedure 60(b). Any modification
`shall be effective upon the filing and entry of an order granting such a motion with the Court.
`
`VI. CONTINUING JURISDICTION
`10. The Court shall retain jurisdiction for the purposes of overseeing compliance with
`the terms of this Consent Decree; resolving any disputes arising under this Consent Decree;
`resolving any motions to modify the terms of this Consent Decree; issuing such further orders or
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 6 of 11
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`directions as may be necessary or appropriate to construe, implement, modify, or enforce the
`terms of this Consent Decree; resolving all claims regarding attorneys’ fees and costs as they
`relate to the Consent Decree; and granting any further relief as the interests of justice may
`require. See Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375 (1994). Except as
`otherwise stated in this Consent Decree, the Parties retain all procedural and other rights related
`to such proceedings.
`
`VII. EFFECTIVE DATE
`11. This Consent Decree shall be effective upon the date of its entry by the Court. If for
`any reason the Court does not enter this Consent Decree as executed by the Plaintiffs and
`Defendants, all terms set forth herein are null and void.
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`VIII. TERMINATION OF CONSENT DECREE AND DISMISSAL OF CLAIMS
`12. This Consent Decree shall terminate without further judicial action upon the
`occurrence of the last FDA action under Paragraph 4 of this Consent Decree.
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`IX. NOTICE AND CORRESPONDENCE
`13. Any notice required or made with respect to this Consent Decree shall be in writing
`and shall be effective on the date that notice is delivered by electronic mail unless the sender
`learns that it did not reach the person to be served. For any matter relating to this Consent
`Decree, the contact persons are:
`
`
`
`
`
`George A. Kimbrell
`Center for Food Safety
`2009 NE Alberta St., Suite 207
`Portland, OR 97211
`gkimbrell@centerforfoodsafety.org
`(971) 271-7372
`
`Daniel K. Crane-Hirsch
`Consumer Protection Branch
`United States Department of Justice, Civil Division
`PO Box 386
`Washington, DC 20044-0386
`Daniel.Crane-Hirsch@usdoj.gov
`(202) 616-8242
`
`
`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 7 of 11
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`Julie B. Lovas
`Office of the General Counsel, Food & Drug Division
`United States Department of Health and Human Services
`10903 New Hampshire Avenue, WO 31-4520
`Silver Spring, MD 20993
`julie.lovas@fda.hhs.gov
`(301) 796-8575
`Upon written notice to the other Parties, any Party may designate a successor contact
`person for any matter relating to this Consent Decree.
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`X.
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`RELEASE BY PLAINTIFFS AND RESERVATION OF RIGHTS
`14. Plaintiffs agree that upon entry by the Court, this Consent Decree shall constitute full
`satisfaction and shall serve as a release of all their claims in Center for Food Safety v. Azar.
`15. Plaintiffs further release, discharge, and covenant not to assert any and all claims,
`causes of action, suits, or demands of any kind in law or in equity that they may have had, or
`may now have, against Defendants upon the same transactions or occurrences as those at issue in
`the Complaint.
`16. Nothing in this Consent Decree shall limit Plaintiffs’ rights to assert the claim
`pleaded in Plaintiffs’ Complaint and make any legal or factual assertions necessary to support a
`claim, in the event that the Parties are before the Court pursuant to Paragraphs 5–8 (“Extensions
`”) or Paragraph 9 (“Dispute Resolution and Modification”). Nor shall anything in this Consent
`Decree be construed to limit Defendants’ arguments in favor of modifying the schedule
`established in this Consent Decree or concerning any Dispute Resolution or Modification.
`17. Nothing in this Consent Decree shall waive or limit Plaintiffs’ rights to challenge, in
`a separate lawsuit, the merits of any final agency action taken by FDA pursuant to this Consent
`Decree (or any final agency action taken by FDA implementing FSMA), including but not
`limited to claims relating to whether FDA’s final action complies with FSMA, the
`Administrative Procedure Act, and other applicable laws.
`18. This release does not encompass any claims by Plaintiffs related to this action,
`pursuant to the Equal Access to Justice Act, for their fees and costs in this matter, which shall be
`resolved pursuant to a separate, concurrent agreement entered by this Court.
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 8 of 11
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`XI. MUTUAL DRAFTING AND CONSTRUCTION
`19. It is expressly understood and agreed that this Consent Decree was jointly drafted by
`the Parties. Accordingly, the Parties hereby agree that any and all rules of construction to the
`effect that ambiguity is construed against the drafting party shall be inapplicable in any dispute
`concerning the terms, meaning, or interpretation of this Consent Decree.
`
`XII. EFFECT OF CONSENT DECREE
`20. This Consent Decree shall not constitute an admission or evidence of any issue of
`fact or law, wrongdoing, misconduct, or liability on the part of any Party. The Parties agree that
`this Consent Decree was negotiated in good faith and that this Agreement constitutes a
`settlement of claims that were denied and disputed by the Parties.
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`XIII. SCOPE OF CONSENT DECREE
`21. Except as expressly provided in this Consent Decree, none of the Parties waives or
`relinquishes any legal rights, claims, or defenses it may have. Nothing in this Consent Decree
`shall be construed to confer upon the Court jurisdiction to review any decision, either procedural
`or substantive, to be made by FDA pursuant to this Consent Decree, except for the purposes of
`determining FDA’s compliance with this Consent Decree. Nothing in this Consent Decree shall
`be construed to make any non-Party a third-party beneficiary of this Consent Decree. Nothing in
`this Consent Decree alters or affects the standards for judicial review of any final FDA action.
`
`XIV. COUNTERPARTS
`22. This Consent Decree may be executed in any number of counterpart originals, each
`of which will be deemed to constitute an original agreement, and all of which shall constitute one
`agreement. The execution of one counterpart by any Party shall have the same force and effect as
`if that Party had signed all other counterparts.
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 9 of 11
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`XV. ENTIRE AGREEMENT
`23. This Consent Decree is the entire agreement between the Parties in this case. All
`prior conversations, meetings, discussions, drafts, and writings of any kind are specifically
`superseded by this Consent Decree.
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`XVI. APPLICABLE LAW
`24. This Consent Decree shall be governed by and construed under the laws of the
`United States.
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`XVII. COMPLIANCE WITH OTHER LAWS
`25. This Consent Decree requires FDA to take certain actions by a date certain, as
`described above. No provision of this Consent Decree shall constitute or be interpreted as
`permitting or requiring FDA to take any action in contravention of any law or regulation, either
`substantive or procedural.
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`XVIII. REPRESENTATIVE AUTHORITY
`26. Each undersigned representative of the Parties to this Consent Decree certifies that
`he or she is fully authorized by such Party to enter into and execute the terms and conditions of
`this Consent Decree and to legally bind such Party to this Consent Decree. By signature below,
`the Parties consent to entry of this Consent Decree. Signature on a counterpart or authorization of
`an electronic signature shall constitute a valid signature.
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 10 of 11
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`/s/ George Kimbrell
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`
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`
`
`GEORGE A. KIMBRELL (admitted Pro Hac
`Vice)
`RYAN D. TALBOTT (admitted Pro Hac Vice)
`Center for Food Safety
`2009 NE Alberta Street, Suite 207
`Portland, OR 97211
`T: (971) 271-7372
`Emails:
`gkimbrell@centerforfoodsafety.org
`rtalbott@centerforfoodsafety.org
`
`JOSEPH H. HUNT
`Assistant Attorney General
`DAVID M. MORRELL
`Deputy Assistant Attorney General
`GUSTAV W. EYLER
`Director
`ANDREW E. CLARK
`Assistant Director
`Consumer Protection Branch
`
`/s/ Daniel K. Crane-Hirsch
`DANIEL K. CRANE-HIRSCH
`Trial Attorney
`Consumer Protection Branch
`U.S. Department of Justice, Civil Division
`P.O. Box 386
`Washington, D.C. 20044-0386
`Telephone: 202-616-8242
`Fax: 202-514-8742
`daniel.crane-hirsch@usdoj.gov
`
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`For Plaintiffs:
`Date: June 7, 2019
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`For Defendants:
`Date: June 7, 2019
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`Of Counsel:
`ROBERT P. CHARROW
`General Counsel
`STACY CLINE AMIN
`Chief Counsel
`Food and Drug Administration
`Deputy General Counsel
`Department of Health and Human Services
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`CONSENT DECREE
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`Case 4:18-cv-06299-YGR Document 34 Filed 06/11/19 Page 11 of 11
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`ANNAMARIE KEMPIC
`Deputy Chief Counsel for Litigation
`JULIE B. LOVAS
`Senior Counsel
`Office of the Chief Counsel
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`White Oak 32, Room 4520
`Silver Spring, MD 20993-0002
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`ENTERED AND DATED this _____ day of ____________, 2019.
`
`________________________________
`United States District Court Judge
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`CONSENT DECREE
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`11
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`11th
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`June
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