Posted February 27, 2014
The U.S. Food and Drug Administration (FDA) recently
agreed to new deadlines for final rules for the Food Safety Modernization Act
(FSMA), according to an article by Food Navigator-USA available here. National Law Review also reported on the
story here.
The agreement is part of a settlement between FDA and
the Center for Food Safety in Center for
Food Safety, et al., v. Hamburg, filed against the FDA in August 2012. The U.S.
District Court for the Northern District of California set deadlines and ruled
in August of last year that the FDA may not extend those deadlines on the final
rules. The FDA will drop its
appeal in that case as part of the agreement.
The consent decree is available here.
The new deadlines for issuing final rules are staggered
for different rules: August 30, 2015 for preventative controls for human and
animal food; October 31, 2015 for imported food and foreign suppliers; October
31, 2015 for produce safety; March 31, 2016 for food transportation; and May
31, 2016 for intentional adulteration of food.
The FSMA, Pub. L. No. 111-353, 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, and peanut butter and other peanut products
contaminated with Salmonella Typhimurium.
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 will 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’s website here
and here.
