Food Safety Modernization Act and Animal Food
The Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, 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 from responding to contamination of the food supply to preventing 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.
What's New - FDA Finalizes Guidance to Help Facilities Determine Their Business Size Under FSMA Preventive Controls Regulations
June 20, 2019
The U.S. Food and Drug Administration has finalized guidance to help facilities determine their business size under the Preventive Controls for Human Food (PC Human Food) and Preventive Controls for Animal Food (PC Animal Food) rules issued in response to the FDA Food Safety Modernization Act (FSMA).
Under the PC Human Food and PC Animal Foods rules, a facility that is a “small business” may have a later compliance date and certain activities performed by a farm mixed-type facility that is a “small business” are exempt from the preventive controls requirements of the PC rules.
A “small business” is defined in the rules as a business (including any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees. The limit of 500 employees includes all employees of the business and is not limited to the employees at a particular facility. But what does “full-time equivalent employee” mean? And if you have a business with subsidiaries or affiliates how should you go about determining your number of employees?
The final guidance issued today is designed to answer these questions. The guidance explores key definitions such as “subsidiary,” “affiliate” and “full-time equivalent employee.” It also offers a method for calculating full-time equivalent employees, and examples of the types of situations facilities might experience when trying to decide which employees to count to determine whether they are a small business.
For More Information
- Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
- FSMA Final Rule for Preventive Controls for Animal Food
Overview of FSMA
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.
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.
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 2019 (October 1, 2018 through September 30, 2019) 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.
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)
- Final Rule for Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
- Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
- Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507
- Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation
- Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs Regulation
- 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.
- More information, including a Public Registry of Recognized Accreditation Bodies can be found on the Accredited Third-Party Certification Program web page.
- Accredited Third-Party Certification Program Portal Electronic User Guide
- Public Registry of Recognized Accreditation Bodies
- Final Rule on Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
- Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards
- 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
Inspection & Compliance
FSMA provides FDA with important new tools for inspection and compliance. Specific implementation dates specified in the law 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 the records firms will be required to keep documenting implementation of their 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 due two years after enactment)
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.
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 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.
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)
- Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule
- Guidance for Industry: Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation - Small Entity Compliance Guide
- Training for Carriers covered by the Sanitary Transportation of Human and Animal Food Rule
- Guidance for Industry: Determination of Status as a Qualified Facility
- Instructions for Submitting Qualified Facility Attestation
- Qualified Facility Attestation for Animal Food Facility (Form 3942b)
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 new food safety requirements of the law. Specifically, for several key provisions, the law mandates “plain language” guidance documents and phased-in effective dates. These include:
- Registration - FDA will issue “plain language” guidance on registration procedures for small entities within six months of issuing registration rule. (Section 102 of FSMA)
- Hazard Analysis and Preventive Controls
FDA issued a small entity compliance guidance to assist small and very small businesses with the implementation of the Preventive Controls for Animal Food rule.
- Small businesses, those with fewer than 500 full-time employees, must comply with the animal food rule by September 18, 2017.
- Very small businesses, generally those averaging less than $2.5 million per year in animal food sales, are required to maintain records supporting Qualified Facility status as of January 1, 2016.
- Qualified facilities need to come into compliance with the animal food rule by September 17, 2018.
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide
- Guidance for Industry: The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide
- Tracking and Tracing
- FDA will issue “plain language” guidance for small businesses within six months of issuing rule on tracking and tracing food and recordkeeping. (Section 204 of FSMA)
- Rule on recordkeeping takes effect for small business one year after effective date, and for very small businesses two years after effective date. (Section 204 of FSMA)
- Guidance for Industry: What You Need to Know About Establishment and Maintenance of Records
- Guidance for Industry: FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act
- Final Rule: Record Availability Requirements: Establishment, Maintenance, and Availability of Records
- Training and Education - FDA will enter into agreement with USDA to establish competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to farmers, small food processors and small fruit and vegetable merchant wholesalers. (Section 209 of FSMA)
- Frequently Asked Questions on FSMA
- FSMA Rules & Guidance for Industry
- Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)