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U.S. Department of Health and Human Services

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Resources for You

Timeline - FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) is an important piece of legislation with many requirements. FDA has prepared this timeline to help you find some of the specific deadlines for industry and/or the FDA.

This timeline is not a complete summary of the law.  It is very important to note that in order to understand the full context of each section described below, you must read the full text of the FSMA.

View an interactive version of the timeline.

DateAction
January 2011President Obama signed the FDA Food Safety Modernization Act into law
April 2011FDA Issues Guidance to Seafood Industry on Food Safety Hazards
As required under FSMA, FDA issued its updated guidance to the seafood industry. The guidance provides current information relating to hazards associated with fish and fishery products and appropriate controls for those hazards. FDA allows processors of fish and fishery products to use an alternative approach to control these hazards if such approach satisfies the requirements of the applicable statute and regulations. This is the fourth edition of the guidance, the FDA FSMA webpage also features a video introducing the guidance.
(SEC. 103)
April 2011Consumer-Friendly Web Search for Recalls Launched
As required under FSMA, FDA launched April 4 a more consumer-friendly recall search engine on the FDA website. To provide greater ease of use for consumers, the search results provide data from news releases and other recall announcements in the form of a table. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm. The table also provides a link to the news release on each recall for more detailed information. The news releases were chosen as the source of information for the table because they provide the most up-to-date and user-friendly information about any recall.
(SEC. 205)
April 2011HHS Sends Congress First Annual Report
As required under FSMA, HHS Secretary Sebelius submitted to Congress on April 6 the first annual “Report on Food Facilities, Food Imports, and FDA Foreign Offices.” The report briefly describes the scope of FDA’s responsibility and its activities in protecting the U.S. food supply under its jurisdiction. It also discusses how federal, state and local agencies cooperate with FDA in that effort. Baseline data are provided on the cost and number of domestic and foreign food facility inspections; the numbers of field samples analyzed to support FDA’s compliance actions; and FDA’s foreign posts and their staff who extend the international impact of FDA.
(SEC. 201)
May 2011Preventive Controls for Registered Human Food and Animal Food/Feed Facilities Docket Opens
On May 23, FDA announced the opening of a docket to obtain information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. FDA established this docket to provide an opportunity for interested parties to provide information and share views that will inform the development of guidance on preventive controls for food facilities that manufacture, process, pack, or hold human food or animal food/feed (including pet food.  Comments are due August 22, 2011.
(SEC. 103)
May 2011Interim Final Rule on Criteria for Administrative Detention Issued
On May 5, FDA issued an interim final rule on criteria used to order administrative detention of food for humans or animals.  The rule changes the criteria for ordering administrative detention of human or animal food. Under the new criteria, FDA can order administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This will further help FDA prevent potentially harmful food from reaching U.S. consumers.
(SEC. 207)
May 2011Interim Final Rule on Prior Notice of Imported Food Issued
On May 5, FDA issued an interim final rule requiring that a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.  The new information can help FDA make better informed decisions in managing potential risks of imported food into the United States.
(SEC. 304)
July 2011MOU Signed with USDA
On July 1, FDA and United States Department of Agriculture (USDA), National Institute of Food and Agriculture (NIFA), entered into an agreement to collaborate on the establishment of a competitive grant program for food safety training, and other projects, as part of a Memorandum of Understanding with USDA’s Research, Education and Economics Agencies.
(SEC. 209)

July 2011

Joint Anti-Smuggling Strategy Issued
On July 5, FDA issued an anti-smuggling strategy that was developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS).
(SEC. 309)

July 2011

Draft Guidance for the Dietary Supplement Industry Issued
On July 5, FDA issued draft guidance for the dietary supplement industry that clarifies for industry its expectations regarding new dietary ingredients.
(SEC. 113)

August 2011

2012 User Fees
On August 1, FDA published, through a Federal Register Notice, the fiscal year (FY) 2012 fee schedule for certain domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections.
(SEC. 107)
September 2011 

Report Published on the Food Emergency Response Laboratory Network (FERN)
This report to Congress describes coordination and capacity of 172 food-testing laboratories at the Federal, State, local, and tribal levels into a network as they respond to food safety emergencies involving biological, chemical or radiological contamination of food.  
(SEC. 202)

October 2011

FDA Provides Guidance on FSMA Fees
On October 6, 2011, FDA issues a Federal Register Notice guidance for industry entitled "Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act'' to provide guidance to industry on the implementation of the fee provisions of section 107 of the FDA FSMA.
(SEC. 107)

December 2011FDA Partners with Industry, Academia on Preventive Controls Alliance
FDA in cooperation with the Illinois Institute of Technology’s Institute for Food Safety and Health (IIT IFSH) creates the Food Safety Preventive Controls Alliance (FSPCA) to develop training courses and materials on preventing contamination for both human and animal food during production.
(SEC. 103)
February 2012Interim Final Rule and Guidance on Records Access
On February 22, 2012, FDA issues an Interim Final Rule and updated Guidance for Industry on records Access to be consistent with FDA's records access under sec. 414(a) of the FD&C Act, as expanded on Section 101 of the FSMA.
(SEC. 101)
June 2012

FDA’s Plan to Build Foreign Food Safety Capacity
FDA holds 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.
(SEC. 305)

August 2012

Updated Guidance for Registration
FDA releases an updated draft guidance to notify industry of additional food categories that may be included in the food facility registration as mandatory fields, as provided by FSMA, including food categories currently listed in the form as optional fields.
(SEC. 102)

August 2012

Report to Congress Released
The second Annual Report on Food Facilities, Food Imports and FDA Foreign Offices was submitted to Congress. The report briefly describes the scope of FDA’s responsibility and its activities in protecting the U.S. food supply under its jurisdiction.
(SEC. 201)

August 2012

Updated Guidance for Registration
FDA releases an updated draft guidance to notify industry of additional food categories that may be included in the food facility registration as mandatory fields, as provided by FSMA, including food categories currently listed in the form as optional fields.
(SEC. 102)

October 2012

Updated for Registration Guidance
Final version of the updated guidance, Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories is released. It represents conclusion on the necessity of food product categories in food facility registrations submitted under sec. 415 of the FD&C Act, as added by sec. 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by sec. 102 of the FSMA.
(SEC. 102)

December 2012

Updated Q&A on Facility Registration
The 5th edition of Guidance for Industry: Questions and Answers Regarding Food Facility Registration is released. It includes questions and answers relating to the FSMA amendments to section 415 of the FD&C Act and revisions to clarify, delete, and renumber the questions and answers in the 4th edition.
(SEC. 102)

December 2012

Updated Guidance for Registration
FDA releases updated guidance, What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide. 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.
(SEC. 102)