The Food Safety Modernization Act (FSMA), passed by the 111th US Congress, is the most sweeping reform of food safety laws in our lifetime. It was signed into law by President Obama on January 4, 2011 and shifts food safety in the United States to a preventive focus as opposed to responding to contamination and outbreaks.
How will FSMA be implemented?
The U.S. Food and Drug Administration (FDA) is required to issue a number of new rules including: preventive controls for human food, preventive controls for animal feed, produce safety, and a foreign supplier verification program.
How does the rule-making process work?
Step 1: FDA Proposes a Rule and Requests Comments – FDA issues a proposed rule, also known as a Notice of Proposed Rulemaking (NPRM). This proposal is published in the Federal Register (FR) so that members of the public can review and comment on it.
Step 2: FDA Considers Comments and Issues a Final Rule – FDA considers the comments received during the comment period on the proposed rule and will consider revising the rule based on review of the comments. A final rule is then issued.
Step 3: Companies Comply with the Rule Based on the “Effective Date” – When a final rule is published, it has an effective or compliance date which may be in the future. This date is sometimes established in the law. The amount of time before a rule goes into effect can vary. It may be six months from publication of the final rule or it may be a year from publication. In addition, sometimes a final rule provides accommodations for small businesses.
FDA Resource for Specific FSMA Questions
FDA has developed the Technical Assistance Network (TAN) to answer industry questions on FSMA implementation. Submit your question on-line and provide as much detail as possible to allow FDA to evaluate the specific situation and provide answers to your FSMA questions. FDA subject matter experts will answer questions as soon as possible although they caution response times may vary due to the complexity of the question and the volume of inquiries. Industry questions will be used to assist FDA in developing guidance and training programs as well as Frequently Asked Questions (FAQs) to be posted on FDA’s website.
Want to learn more about FSMA?
For an up-to-date timeline on the progress of FSMA implementation or to find more information on FSMA, you can visit the FDA Website.
FSMA Compliance Information
Food Safety Preventive Controls Alliance (Technical Assistance Network TAN Webform Info) – technical questions
For technical questions that may arise, the FSPCA Technical Assistance Network (TAN) provides technical assistance to industry, academia and others regarding training and scientific/technical questions related to FDA’s Preventive Controls human food and animal food regulations.
FDA FSMA Technical Assistance Network
For regulatory interpretation or specific regulatory questions related to FSMA, the following link is available to receive input from FDA subject matter experts.
FDA guidance on the Voluntary Qualified Importers Program is available here: