Federal Judge Orders FDA to Issue Overdue Food Safety Rules by November 2013

On Friday, June 21, a federal judge in California imposed concrete deadlines for the U.S. Food and Drug Administration (FDA) to publish and finalize all remaining overdue rules to implement provisions of the FDA Food Safety Modernization Act (FSMA).[1] 

FSMA set specific deadlines for FDA to publish proposed rules or guidance to implement certain provisions of the law; FDA has failed to meet several of these deadlines.  In August 2012, two consumer interest groups – the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) – sued FDA in the Northern District of California to compel the Agency to publish the overdue rules.

On April 22, 2013, the California court granted summary judgment to the consumer groups, ordering FDA to work with CFS and CEH to develop a mutually agreeable proposal setting forth deadlines for FDA’s issuance of the overdue rules.  FDA and the consumer groups could not reach agreement on an acceptable timeline; consequently, the parties submitted separate proposals to the court. 

The California court found FDA’s proposed “target timeframes” to be inadequate and the consumer groups’ proposed deadlines to be overly restrictive.  Thus, the court ordered FDA to publish all proposed regulations that have not yet been published in the Federal Register by November 30, 2013.  For each rule, the comment period must end by March 31, 2014.  FDA must publish all final regulations no later than June 30, 2015.

FDA now faces the task of publishing proposed rules to implement and address:

• The foreign supplier verification program (FSVP) (Section 301 of FSMA)
• Preventive controls for animal feed (Section 103 of FSMA)
• Protection against intentional adulteration (Section 106 of FSMA)
• Sanitary transportation of food (Section 111 of FSMA)
• Accreditation of third-party auditors (Section 307 of FSMA)

Of the proposed rules referenced above, the FSVP rules are the longest overdue.  Under FSMA, FDA should have issued FSVP implementing rules by January 5, 2012.  Foreign food manufacturers and distributors are still waiting to learn exactly how the Agency’s proposal will affect imports and trade.

Complying with the court order likely will prove challenging for FDA due to factors such as the complexity of the required rulemaking, the Agency’s need to consider and respond to public input on rules, limited Agency resources, and the requirement for the Office of Management and Budget (OMB) to review drafts of significant regulatory actions. 

Keller and Heckman LLP will continue to monitor FSMA-related developments and will keep clients and interested parties apprised.  We are available to answer any questions that you might have regarding FSMA and FDA’s implementation activities to date.  Please contact Melvin S. Drozen (drozen@khlaw.com) (202-434-4222), Evangelia C. Pelonis (pelonis@khlaw.com) (202-434-4106) or Alissa D. Jijon (jijon@khlaw.com) (202-434-4109) for further assistance.