Food Safety Modernization Act (FSMA)

FSMA Overview

For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

FSMA Resources

Use these FSMA resources to learn more about the rules and for guidance. For more information about the food safety rules, contact Bryan Hitchcock, Senior Director Food Chain & Executive Director of the Global Food Traceability Center.

Disclaimer: The materials on this website are provided for informational purposes only and do not constitute legal advice. IFT does not advise on the application of law to an individual’s or company’s specific circumstances.

Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense)
Final Status: May 27, 2016
This rule is intended to protect food from intentional acts of adulteration where there is an intent to cause wide scale public health harm. This rule applies to both domestic and foreign facilities that are required to register under section 415 of the FD&C Act.

Sanitary Transportation of Human and Animal Food (Sanitary Transportation)
Final Status: April 6, 2016
This rule is intended to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.

Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (Accredited Third-Party Certification)
Final Status: November 27, 2015
This rule is intended to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA).

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs (FSVP)
Final Status: November 27, 2015
This rule is intended to require importers to verify that food they import into the United States Is produced in compliance with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FDA&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety)
Final Status: November 27, 2015
This rule is intended to minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, by establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food)
Final Status: September 17, 2015
The rule is intended to modernize requirements for current good manufacturing practices (cGMPs) and for domestic and foreign facilities that are subject to Registration of Food Facilities to establish and implement hazard analysis and risk-based preventive controls for human food.

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Food for Animals)
Final Status: September 17, 2015
This rule is intended to establish requirements for the current good manufacturing practice (cGMP) for food for animals and for certain domestic and foreign animal food facilities to establish and implement hazard analysis and risk-based preventive controls for food for animals.

FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act
Final Status: April 4, 2014
The draft guidance provides updated information pertaining to FDA's authority to access and copy records relating to food. It is a revision of FDA's November 2005 guidance entitled “Guidance for Industry and FDA Staff: Guidance for Records Access Authority Provided in Title III, Subtitle A, of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Final Guidance.”

Questions and Answers Regarding Food Facility Registration (Sixth Edition)
Final Status: November 19, 2014
The guidance provides updated information pertaining to registration of human and animal food facilities under the FD&C Act, as amended by FSMA on January 4, 2011.

Questions and Answers Regarding Establishment and Maintenance of Records by Persons who Manufacture, Process, Pack, Transport, Distribute, Receive, Hold, or Import Food (Edition 5)
Final Status: February 23, 2012
The guidance provides updated information pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FSMA of January 4, 2011.

What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide
Final Status: October 25, 2011
The guidance restates the legal requirements in section 304(h) of the FD&C Act 21 U.S.C. 334(h), as amended by section 207 of FSMA.

Full Text of the Food Safety Modernization Act (FSMA)
The full text of 111 Congress Public Law 353, Food Safety Modernization Act (FSMA), as provided by the FDA.

FDA Food Safety Modernization Act (FSMA) Main Page
FDA published information about FSMA. Includes up-to-date announcements and implementation activity.

Background on the FDA Food Safety Modernization Act (FSMA)
FDA background document on purpose and history of the FSMA. Available in multi-language translation and PDF.

Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)
This strategy document is intended to guide the next phase of FSMA implementation by outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change, as mandated and empowered by FSMA.

FSMA Training
Training and outreach programs to assist companies in complying with the FSMA rules.

Frequently Asked Questions on Food Safety Modernization Act (FSMA)
This page addresses questions related to FSMA.

IFT offers several webcasts on the final and proposed FSMA rules. Free to IFT Premiere Members, login required. Network & Engagement member discount and non-member pricing also available.

FSMA Final Rule for Produce Safety: Significant Provisions of the Rule

FSMA Final Rule for Foreign Supplier Verification Programs (FSVP)

FSMA Requirements: Validation of the Kill Step in Bakery Products – AIB Supplier Solutions Webcast

FSMA Final Rule for Preventative Controls for human Food Webcast