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.
April 25, 2014
April 3, 2014 - FDA Issues Final Rule on Record Access Requirements for Food Firms and Announces Guidance for Industry
The major elements of the law can be divided into five key areas:
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 reinspections. 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:
See the Assessment of Reinspection and Recall Fees by the FDA for more information.
FDA announced in a Federal Register notice the fiscal year FY 2014 (October 1, 2013 through September 30, 2014) fee schedule. The rates are as follows: $237 an hour if no foreign travel is required and $302 an hour if foreign travel is required.
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. FDA is extending the comment period on the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals and the Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications proposed rules until January 27, 2014. Specific implementation dates specified in the law are noted in parentheses:
FSMA provides FDA with important new tools for inspection and compliance. Specific implementation dates specified in the law are noted in parentheses:
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.
Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of the FSMA
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)
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: