The Food Safety Modernization Act (FSMA) was the most sweeping reform of our food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus to preventing contamination of the food supply, rather than responding to it. The law applies to human food as well as to food for animals, including pets. FDA’s FSMA page contains complete information about the implementation of the law, and the intent of this page is to highlight the FSMA content that will be of most interest to manufacturers and distributors of animal food. If you are interested in starting a new animal food business and learning about the regulatory requirements to manufacture, process, pack, hold, import, or export animal food, please go to the “How do I Start an Animal Food Business?” page. Please go to the Safe Feed page for additional, specific information about the regulation of animal food including premarket approval and labelling requirements.
- FDA Announces FY2024 User Fee Rates Under the Food Safety Modernization Act for the Voluntary Qualified Importer Program and the Accredited Third-Party Certification Program - July 2023
- FDA Updates Duration of Enforcement Discretion Policies in Two COVID-19 Era FSMA Guidances - July 2023
- FDA Issues the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Final Guidance - January 2023
- FDA Issues Final Guidance on Refusal of Inspection by a Foreign Food Establishment or Foreign Government - October 2022
- Now Available: Small Entity Compliance Guide for Laboratory Accreditation for Analyses of Foods Program - October 2022
- FDA Posts New FAQs for the FSMA Lab Accreditation for Analyses of Foods Final Rule - August 2022
The new FAQs review general requirements for test methods used under the LAAF program; clarify that FDA does not maintain a comprehensive list of test methods performed by LAAF-accredited laboratories; and describe the specific test methods that are required in certain circumstances covered by the LAAF final rule.
- Food Facilities Invited to Join “How To” Webinar on Registration and Renewal as Biennial Food Facility Registration Period Approaches - July 2022
- IMPORTANT 30-DAY NOTICE FOR FSVP IMPORTERS RE: “UNK” - Beginning July 24, 2022, the entity identification code “UNK” will no longer be accepted in the Entity Number field by U.S. Customs and Border Protection (CBP). - June 2022
- FDA Posts Answers to Frequently Asked Questions for the FSMA Lab Accreditation for Analyses of Foods Final Rule - June 2022
Overview of FSMA
The major elements of the FSMA law can be divided into five key areas:
- Preventive controls - For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. For animal food, these requirements were established in the Preventive Controls for Animal Food (PCAF) regulation.
- Inspection and Compliance - The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food; thus, the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches. You can find information on FDA’s efforts to inspect animal food at FDA-TRACK: Center for Veterinary Medicine - Animal Food Safety.
- Imported Food Safety - FDA has new tools to ensure that those imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
- Response - For the first time, FDA will have mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls.
- Enhanced Partnerships - The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, State, local, territorial, tribal and foreign--to achieve our public health goals. For example, it directs FDA to improve training of State, local, territorial and tribal food safety officials.
The following are among FDA’s key import authorities and mandates:
- Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. The Final Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals is the regulation that helps provide for this accountability by requiring that food human and animal food is, in part, produced in a manner that provides the same level of public health protection as those provided for in the FSMA Preventive Controls for Human and Animal Food regulations. More information on the FSVP rule, including pertinent guidance and frequently asked questions can be found on the FSMA FSVP page.
- Third Party Certification: FSMA established a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. The Accredited Third-Party Certification Program is a voluntary program in which FDA recognizes “accreditation bodies” that will have the responsibility of accrediting third-party “certification bodies.” Accreditation bodies recognized by FDA will have the authority to accredit third-party certification bodies, also known as third-party auditors. These certification bodies, once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods – both human and animal – that they produce. This certification may be used to facilitate the entry of imports.
- A Public Registry of Recognized Accreditation Bodies and Certification Bodies can be found on the Accredited Third-Party Certification Program data dashboard.
- Laboratory Accreditation for Analysis of Foods (LAAF): The FDA Food Safety Modernization Act (FSMA) final rule on Laboratory Accreditation for Analyses of Foods (LAAF) establishes a laboratory accreditation program for the testing of food in certain circumstances.
- A Public Registry of Recognized Accreditation Bodies and LAAF-Accredited Laboratories can be found on the Laboratory Accreditation for Analyses of Foods Program data dashboard.
- Voluntary Qualified Importer Program (VQIP): VQIP is a voluntary, fee-based program that allows importers to receive expedited review and importation of foods into the United States if they apply, and then achieve and maintain, a high level of control over the safety and security of their supply chains. The FDA was required to establish VQIP by the FDA FSMA. While VQIP can be a benefit for both industry and consumers, the VQIP program is currently not available for animal food.
- Guidance for Industry: FDA's Voluntary Qualified Importer Program
- Importers that are interested in VQIP can learn more about fees and access the application by visiting Voluntary Qualified Importer Program (VQIP).
- Supplier Evaluation Resources: FDA has provided a Supplier Evaluation Resource for Industry to help them fulfill the requirement in three FDA FSMA rules, including FSVP, to evaluate, among other things, a supplier’s compliance with FDA regulations, including whether the supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety.
Inspection & Compliance
FSMA provides FDA with important new tools for inspection and compliance.
- Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
- Information on inspections, including the current good manufacturing practice and preventive control requirements of the FSMA Preventive Controls for Animal Food can be found on the FDA-TRACK: FSMA Dashboards.
- Records access: FDA will have access to records, including industry food safety plans and those required to be kept documenting implementation of the plans.
- Administrative Detention: The changes made by FSMA to the criteria for administrative detention in the FD&C Act further strengthened FDA’s ability to prevent potentially unsafe food from entering commerce. Under the new criteria, FDA can order an administrative detention if the agency has reason to believe that an article of food is adulterated or misbranded. Prior to FSMA, FDA could order an administrative detention if it had credible evidence or information that the food presented a threat of serious adverse health consequences or death to humans or animals.
- Authority to deny entry: FDA can refuse entry into the United States of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located. Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
Animal food facilities are required to register with FDA if your company manufactures, process, packs, or stores an animal food in the United States unless an exemption applies to your business. The requirement to register is a factor in determining what facilities are subject to certain FSMA regulations, including the FSMA Preventive Controls for Animal Food Regulation. Information on registration can be found on CVM’S How to Start an Animal Food Business page.
Under FSMA, FDA was given a legislative mandate to require comprehensive, science-based preventive controls across the food supply, including mandatory preventive controls for food facilities. Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure that they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise.
FDA is expressly authorized to modify the preventive controls requirements for facilities that are solely engaged in the production of animal foods or to exempt those facilities entirely from the preventive controls requirements.
Preventive Controls for Animal Food
In September 2015, FDA published the final Current Good Manufacturing Practice and Risk-Based Preventive Controls for Food for Animals, also known as the Preventive Controls for Animal Food or PCAF rule. The PCAF rule established for the first time both current good manufacturing practice (CGMP) and hazard analysis and risk based preventive controls (PC) requirements for animal food. The CGMP requirements are baseline safety and sanitation requirements for the manufacturing, processing, packing and holding of animal food. Under the PC requirements, animal food facilities are required to have a food safety plan that includes an analysis of hazards to determine which ones need risk based preventive controls, preventive controls to significantly minimize or prevent the hazards, and a process to verify appropriate implementation of this controls. Information on the PCAF rule, including guidance documents and frequently asked questions can be found on the FSMA PCAF page.
The final Sanitary Transportation of Human and Animal Food (ST) rule advances FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food. The final rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. Information on the ST rule, including relevant guidance document and training for carriers, can be found on the FSMA Sanitary Transportation page.
- Frequently Asked Questions on FSMA
- FSMA Rules & Guidance for Industry
- How do I Start an Animal Food Business?