Food Safety Modernization Act and Animal Food

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. Please go to the Safe Feed page for additional, specific information about the regulation of animal feed.

Recent News

Overview of FSMA
Fees
Imports
Inspection & Compliance
Preventive Standards
FSMA Reports & Studies
Small Business
Additional Information

Overview of FSMA

Compliance Dates

FDA-TRACK: Food Safety Dashboard

Fact Sheet – Enforcement Discretion for Certain FSMA Provisions

FSMA Inflation Adjusted Cut Offs

The major elements of the 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.
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.
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.

Back to the top

Fees

Although FSMA does not require a registration fee to be paid by registered facilities and there is no fee for an initial FDA inspection, FSMA authorizes FDA to assess and collect fees related to certain domestic food facility, foreign food facility, and importer reinspection. The fee for reinspection is to cover reinspection-related costs when an initial inspection has identified certain food safety problems.

These fees affect only those parties in the food and feed industry whose non-compliance results in the following activities:

Facility reinspection – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
- Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls
Importer reinspection - follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency.

FDA announced in a Federal Register notice the fiscal year 2021 (October 1, 2020 through September 30, 2021) fee schedule.

As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms. FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published.

For facility reinspection fees, FDA will invoice the responsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice.

More about Fees

Back to the top

Imports

The following are among FDA’s key new import authorities and mandates. Specific implementation dates specified in the law are noted in parentheses:

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. (Final regulation and guidance due 1 year following enactment)
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.
Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third-party certification or other assurance of compliance as a condition of entry into the United States.
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.
- FDA issued a final guidance for industry for a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. The final guidance is in a question-and-answer format to explain how this program will work.
- VQIP will benefit both industry and consumers. Expedited entry provides importers an incentive to adopt a robust system of supply chain management and will allow FDA to focus its resources on examining and sampling food imports that are more likely to present a potential risk to public health.
- Importers that are interested in VQIP can learn more about fees and access the application by visiting Voluntary Qualified Importer Program (VQIP).
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.
Supplier Evaluation Resources

Guidance for Industry: Prior Notice of Imported Foods Questions and Answers (Edition 3)

Guidance for Industry: FDA's Voluntary Qualified Importer Program

Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government

Back to the top

Inspection & Compliance

FSMA provides FDA with important new tools for inspection and compliance. Implementation dates are noted in parentheses:

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.
Records access: FDA will have access to records, including industry food safety plans and those required to be kept documenting implementation of the plans.
Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high-quality standards. (Establishment of accreditation program is due two years after enactment.)
- FSMA Proposed Rule on Laboratory Accreditation

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.

Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide

Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption; Final Rule

Registration

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)

Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration

Guidance for FDA Staff: Draft Compliance Guide Section 100.250 Food Facility Registration - Human and Animal Food (pdf - 9 pages)

Amendments to Registration of Food Facilities

Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories

Back to the top

Preventive Standards

For the first time, FDA will have 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.

Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

FSMA Final Rule for Preventive Controls for Animal Food

Guidance for Industry: Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency

Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program

Webinar on Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Draft Guidance

Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs

Guidance for Industry: Current Good Manufacturing Practice Requirements for Food for Animals

Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507

Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food

Draft Guidance for Industry: Human Food By-Products for Use as Animal Food

Final Qualitative Risk Assessment - Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (pdf - 68 pages)

Draft Qualitative Risk Assessment - Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (pdf - 67 pages)

External Peer Review of the FDA/CVM Draft Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (pdf - 45 pages)

Final Rule on Sanitary Transportation of Human and Animal Food

Qualified Facility Attestation

Back to the top

Small Business

The FDA Food Safety Modernization Act (FSMA) recognizes the role of small businesses in the food industry and provides for various ways to assist small businesses in meeting the food safety requirements of the law. For several provisions, the law mandates that they are written in “plain language” and that they have phased-in effective dates. These provisions are:

Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507