The Food Safety Modernization Act (FSMA) 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. Implementation of FSMA is ongoing, although many of the significant parts are already implemented.
Foreign Supplier Verification Program (FSVP)
The first compliance date for FSVP implementation was May 30, 2017. FDA developed guidance documents and FAQs on FSVP, which are available here. Additional Guidance documents on FSVP are available on the FDA Website here.
Additional FSMA Resources
FDA also released guidance documents on:
- Preventive Controls
- Accredited Third Party Certification
- What’s New in FSMA
- Intentional Adulteration
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.
FSMA Inspections are beginning now that many compliance dates have passed. Below are resources that ASTA members may find helpful when it comes to FSMA.
Inspection Tools for FSMA
- Appendix 1-Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry
- FSPCA trainings
- IOM: Inspectors Manual
FDA guidance on the Voluntary Qualified Importers Program is available here: