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), which was signed into law on January 4, 2011. The Order Granting Injunctive Relief was issued June 21, 2013.
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 federal district court in California granted summary judgment to the consumer groups, ordering FDA to work with CFS and CEH to develop a mutually agreeable timetable 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 court found FDA's proposed "target timeframes" to be inadequate and the consumer groups' proposed deadlines to be overly restrictive. The court-ordered compromise requires FDA to issue all draft regulations that have not yet been published in the Federal Register by November 30, 2013. For each proposed rule, the comment period must end by March 31, 2014. FDA must finalize all 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 listed above, the FSVP rules are the most overdue. Under FSMA, FDA should have issued FSVP implementing rules by January 5, 2012. 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.
Potentially, FDA regulations concerning the sanitary transportation of food (Section 111 of FSMA) could include requirements for the transportation of food-contact materials. In addition, imported "food" possibly may be interpreted as including packaging materials; thus, in practice, the packaging materials would require third party certifications and manufacturers would be required to develop and maintain a HAACP program to satisfy the foreign supplier verification program (Section 301 of FSMA).