Food Safety Modernization Act and Animal Food
The Food Safety Modernization Act (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 the FSMA regulations, programs, guidance, and frequently asked questions. 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.
Recent News
- FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024 - September 2024
- FDA Announces FY2025 User Fees for VQIP and TPP - July 2024
- 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
Food Facility Registration
Preventive Standards
Inspection & Compliance
Imports
Sanitary Transportation of Human and Animal Food
Additional Information
Food Facility Registration
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 food facility registration can be found on CVM’S How to Start an Animal Food Business page.
Preventive Standards
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.
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 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.
Fact Sheet – Enforcement Discretion for Certain FSMA Provisions
FSMA Inflation Adjusted Cut Offs
Inspection & Compliance
FSMA provides FDA with important new tools for inspection and compliance.
- The FSMA 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.
- 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.
Imports
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 the voluntary, Accredited Third-Party Certification Program (TPP) through which FDA recognized “accreditation bodies” may accredit “certification bodies” to conduct food safety audits and issue certifications of foreign food facilities. This certification may be used to facilitate the entry of imports under the Voluntary Qualified Importer Program (VQIP).
- 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): FSMA established the Laboratory Accreditation for Analyses of Foods (LAAF) program through which FDA recognized “accreditation bodies” may accredit “LAAF-accredited laboratories” to conduct food testing 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.
- 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 the preFSVP, 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.
Sanitary Transportation of Human and Animal Food
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.