Posted August 19, 2013
According to a recent federal district court ruling
issued by Judge Phyllis Hamilton of the U.S. District Court of Northern
California, the Food and Drug Administration (FDA) may not extend deadlines to
publish final rules in implementing the Food Safety Modernization Act (FSMA),
signed into law in 2011. The order is
available here.
The FSMA was passed by the 111th Congress in
December of 2010 in response to several multistate foodborne illness outbreaks
related to FDA-regulated foods including: bagged fresh spinach contaminated
with E.coli 0157:H7, Salmonella in Serrano peppers, melamine
in pet food, peanut butter and other peanut products contaminated with Salmonella Typhimurium, and a nationwide
recall of more than 500 million eggs due to contamination from Salmonella Enteritidis. This comprehensive food safety legislation focuses
on foods regulated by the FDA and amends FDA existing structure and
authorities, via the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et
seq.) and is the largest expansion in food safety since the 1930s. The FSMA is designed to increase the
frequency of inspections at food facilities, enhance record-keeping
requirements, mandate product recalls if a firm fails to voluntarily recall an
item, require comprehensive prevention-based controls throughout the food
supply, improve foodborne illness tracking systems, and increase scrutiny of
food imports.
For detailed information on the FSMA, please visit the National
Agricultural Law Center website here
and here.
In August of 2012, the Center for Food Safety
(CFS) filed a lawsuit against FDA over FSMA deadlines originally ordered by
Congress to be completed by July 2012, according to a Food
Safety News article and the CFS
press release. On April 22, 2013,
the court ruled that FDA violated the FSMA and the Administrative Procedures Act
when it failed to issue FSMA regulations by the FSMA-established deadlines. The April 2013 order granting CFS’s motion
for summary judgment is available here.
On June 21, the court issued an order for injunctive
relief which set deadlines for FDA to publish proposed regulations by November
30, 2013, close the comment periods by March 31, 2014, and publish the final
regulations in the Federal Register by June 30, 2015. The June order is available here.
FDA moved to amend the June order, which the court granted
in part and denied in part in its latest order on August 13, available here. In this ruling, the court extended the
deadline for the “proposed sanitary transport rule 60 days to January 31, 2014”
and extended the comment period for this rule 60 days to May 31, 2014. The court, however, did not extend the final
rule deadline and denied the extension requested by FDA for promulgation of the
intentional adulteration rule, stating that the “court understands the FDA’s
position, and is in sympathy with it, but remains of the opinion that the
dispute here is between the FDA and Congress.”
