On this page:
- New Registration Mandates under the FDA Food Safety Modernization Act
- Sections of the Law Relating to Registration
- Guidance, Rules, and Compliance Guides
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, 2011, enables FDA to better protect public health by strengthening the food safety system. It recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge.
Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.
FSMA amended section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350d], which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. The FSMA amendments to section 415 of the FD&C Act are described below. These amendments are focused on improving the agency's ability to respond to a food-related emergency quickly and efficiently.
- Proposed Rule: Amendments to Registration of Food Facilities
- Compliance Policy Guide: Sec. 100.250 Food Facility Registration – Human and Animal Food
- Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)
- Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories
- Guidance for FDA Staff: Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food