2012 FDA Progress Report on Implementing the Food Safety Modernization Act
The FDA intends to provide regular updates to inform the public and Congress on its progress in implementing the FDA Food Safety Modernization Act (FSMA). This summary does not reference all actions taken by FDA. For a summary of accomplishments during the first year, see FSMA One-Year Progress Report and FSMA 2011 Progress Reports.
First-year anniversary of enactment of the Food Safety Modernization Act.
Sprouts Safety Alliance Established
FDA has embraced a strategy of creating alliances for various foods aimed at education, training and technical assistance for industry and government food safety officials. The latest alliance is the Sprouts Safety Alliance, announced February 28, 2012. Housed at the Illinois Institute of Technology’s Institute for Food Safety and Health, the alliance will develop a core curriculum on sprout safety as well as training and outreach programs.
FDA Issues Interim Final Rule and Guidance on FDA’s Access to Records
Because the records access provisions of FSMA became effective on passage, FDA decided to issue an interim final rule to expedite industry’s understanding of and compliance with records access provisions. In addition to the interim final rule, FDA also published draft guidance and questions and answers for industry. The FSMA amendment simply expands FDA’s former records access beyond records related to the specific suspect article of food which FDA reasonably believes is adulterated and presents a threat of serious adverse health consequences or death to humans or animals to now include records relating to any article of food that is reasonably likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records related to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animal. Once either of the above mentioned circumstances are met, FDA may request all existing records needed to assist the agency in determining whether the circumstances, which gave rise to the records request, exist.
- Draft Guidance: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
- Guidance for Industry: Questions and Answers Regarding Establishment and Maintenance of Records By Persons Who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)
Report to Congress on FDA Foreign Offices
FSMA requires FDA to issue a number of reports to Congress on various topics. FDA issued its latest report, “Report to Congress on FDA Foreign Offices,” in February, 2012. The report describes the Agency’s progress in establishing its foreign offices – 13 to date – as well as their accomplishments and the challenges faced by FDA in the increasingly globalized marketplace it oversees.
Food Safety Collaboration in a Global Food System
Michael R. Taylor, Deputy Commissioner for Foods, presented remarks at the Global Food Safety Conference, Orlando, Florida, February 16, 2012
FDA Announces Foods for Product Tracing Pilots
In a series of Frequently Asked Questions and blog by Sherri McGarry, Senior Advisor, Coordinated Outbreak Response and Evaluation Network, FDA announced the types of foods that will be part of the pilot projects on product tracing.
Identifying High-Risk Facilities
A Frequently Asked Question and fact sheet describe how FDA identifies a high-risk facility and how this approach will be updated.
Ensuring Produce Safety in a Global Food System
Michael R. Taylor, Deputy Commissioner for Foods, presented remarks at the America Trades Produce Conference, Tubac, Arizona, March 22, 2012
Deputy Commissioner Blogs on Produce Safety
On April 17, Deputy Commissioner for Foods Michael R. Taylor posted the blog, “Succeeding on Produce Safety,” to discuss what he heard from stakeholders from the U.S. and Mexico at the America Trades produce conference in Tubac, Arizona.
Deputy Commissioner Speaks on Pet Food Safety
On April 4, Deputy Commissioner for Foods Michael R. Taylor addressed the Pet Food Forum on what FSMA principles mean for the manufacturing of safe pet food.
FDA To Survey State and Local Government Agencies on Food Safety Capacity
On May 31, FDA announced that it had submitted to the Office of Management and Budget for review a survey it intends to field of 1,400 state and local agencies to assess state and local food safety capacity. FDA is required under FSMA to make a report to Congress on the needs for enhancement in the areas of staffing levels, laboratory capacities and information technologies at the state and local levels. View the
Federal Register Notice on the survey of State and Local Government Agencies on Food Safety Capacity.
FDA Provides Information on Food Facility Registration and Categorization
In May, FDA updated the FSMA webpage with a number of new Frequently Asked Questions on risk characterization for domestic food facilities and the registration process for food facilities.
FDA’s Plan to Build Foreign Food Safety Capacity
On June 19, FDA held a public meeting for stakeholders to discuss FDA's comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States. FDA is also establishing a docket to collect comments, data, and information relevant to the capacity-building plan. Transcript and Video of the Public Meeting on Food Safety Capacity Building are available
Webcast and Transcript of the International Capacity Building with Respect to Food Safety Public Meeting Made Available
In June, FDA held a public meeting to discuss FDA's comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States. The transcript and archived webcast of the meeting are now available.
Report to Congress on Food Facilities, Imports and FDA Foreign Offices
On August 15, FDA announced that the second Annual Report on Food Facilities, Food Imports and FDA Foreign Offices was submitted to Congress by HHS Secretary Sebelius in response to Section 201 (b) of the Act. The report briefly describes the scope of FDA’s responsibility and its activities in protecting the U.S. food supply under its jurisdiction.
FDA Updates Guidance for Food Facility Registration
On August 15, FDA released an updated draft guidance, Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories, to notify industry of additional food categories that may be included in the food facility registration form as mandatory fields, as provided by FSMA, including food categories currently listed in the form as optional fields.
FDA Announces FSMA Domestic and Foreign Facility Reinspection, Recall and Importer Reinspection Fee Rates for Fiscal Year 2013
On August 1, FDA announced the availability of the FSMA domestic and foreign facility reinspection, recall and importer reinspection fee rates. These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013.
Deputy Commissioner for Foods Speaks on Progress of FSMA Implementation
On September 11, Deputy Commissioner for Foods, Michael R. Taylor, delivered remarks at the 2012 FDA Science Writers Symposium on the topic of food safety. Specifically, he addressed progress in implementing the FSMA, including new strategies for how FDA will work internally and with our stakeholders and partners to achieve the law’s goals.
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.