FDA Food Safety Modernization Act (FSMA) October-December 2012 Update
FDA Updated Guidance Improves Food Facility Registration
On October 19, FDA released an updated Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories. This guidance represents FDA’s conclusion on the necessity of food product categories in food facility registrations submitted to the FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act, as added by section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by section 102 of the FDA FSMA.
Updated Food Facility Registration System Available for Registration Renewal
On October 22, FDA announced its updated food facility registration system is available for biennial registration renewal. Registrants can submit registration renewals to FDA using the online food facility registration module or paper Form FDA 3537. The agency is offering technical assistance online and through the help desk.
Deputy Commissioner for Foods Speaks on Food Safety and Consumer Confidence in the Global Food System in Shanghai, China
On November 7, Deputy Commissioner for Foods and Veterinary Medicine, Michael R. Taylor, delivered remarks at the China International Food Safety and Quality Conference and Expo in Shanghai, China. He addressed the need to modernize and ensure consumer confidence in the global food safety system and cited the work being accomplished in the U.S. under the FSMA.
FDA Suspends Food Facility Registration of Sunland
On November 26, FDA announced that to protect the public health, it had suspended the food facility registration of Sunland Inc., a producer of nuts, and nut and seed spreads. The fact that peanut butter made by the company had been linked to an outbreak of Salmonella Bredeney that sickened more than 41 people in 20 states, coupled with Sunland’s history of violations, led FDA to make the decision to suspend the company’s registration. This was FDA’s first use of its registration suspension authority under section 102 of FSMA. View a copy of Suspension Order and links to Sunland’s inspection history.
FDA Issues Updated Guidance for Food Facility Registration
On December 12, FDA issued updated Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide, to reflect the FSMA amendments to the FD&C Act. It contains information regarding: who is required to register and who may be exempt; how often facilities must register and renew registrations; when FDA may suspend a registration; and how facilities may submit their registrations and registration renewals to FDA.
FDA Updates Q&A on Food Facility Registration
On December 12, FDA released the fifth edition of Guidance for Industry: Questions and Answers Regarding Food Facility Registration. Updates to this new edition are based on the FSMA amendments. At the same time, FDA indicated that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012, FDA will exercise enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.
FDA Announces Partnership with New Zealand
On December 10, FDA and New Zealand’s Ministry for Primary Industries signed an arrangement recognizing each other’s food safety systems as comparable to each other. This arrangement complements the expanded import tool kit mandated under FSMA and leads the way to a new level of regulatory cooperation to enhance food safety while facilitating trade between the two countries. This is the first time that FDA has recognized a foreign food safety system as comparable. Deputy Commissioner for Global Regulatory Operations and Policy, Deborah Autor, and Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, co-authored a blog post on this new partnership. View a blog post on the Partnership with New Zealand.