FDA Releases Two More Rules Implementing the Food Safety and Modernization Act

Jan 11, 2013   

As we previously reported, President Obama signed the Food Safety and Modernization Act (“FSMA“) in January 2011 to help ensure the safety and security of foods in the United States.  On January 7, 2013, the U.S. Food and Drug Administration (“FDA“) issued two proposed rules implementing the FSMA. Generally, the first proposed rule would require food manufacturers to develop a formal plan for preventing their food products from causing foodborne illness. The second rule proposes enforceable safety standards for the production and harvesting of produce on farms. Interested persons may submit comments by May 16, 2013.

The first proposed rule, entitled “Preventive Control for Human Food,” would revise current good manufacturing practice (“cGMP”) regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (“FDCA”). If implemented, the proposed rule would establish hazard analysis and risk-based preventive controls for human food. Additionally, the proposed rule would require plans for correcting any problems that arise. These requirements are similar to Hazard Analysis and Critical Control Points (“HACCP”) systems required for juice and seafood. See 21 C.F.R. §§ 120 and 123.

The second proposed rule, “Standards for Produce Safety,” would establish science- and risk-based minimum standards for safe growing, harvesting, packing, and holding of domestic and imported produce in order to reduce the likelihood of microbial contamination. The proposed rule would establish standards in the following areas: worker training health and hygiene; agricultural water sanitation; treatment of biological soil of animal origin; equipment sanitation. Certain produce, however, are exempt under the proposed rule, such as commodities that are rarely consumed raw.

The Standards for Produce Safety rule also provides specific standards applicable only to sprouts. Notably, since 1996, there have been at least 30 reported outbreaks of foodborne illness associated with different types of raw and lightly cooked sprouts caused mostly by Salmonella and E. coli. As we previously reported, the International Sprout Growers Association (“ISGA“) urged the FDA to issue new safety standards for the production of sprouts.

The FDA press release assured that three other key draft rules that remain under review at the Office of Management and Budget (“OMB“) will be released soon. The additional rules include (1) requirements for new foreign supplier verification, (2) preventive controls for animal food facilities, and (3) third party audit certification.

Fuerst Ittleman David & Joseph PL will continue to monitor new rules issued by the FDA under the FSMA. For more information regarding the new rules, please contact us at contact@fidjlaw.com or (305) 350-5690.