August 3, 2020

FDA Missed Food Safety Modernization Act Deadlines

A little more than one year ago, President Obama signed the historic Food Safety Modernization Act (FSMA) into law. This law was the first major update to the United States food safety system since the 1906 Pure Foods Act was modified in 1938.

The FSMA set deadlines for the FDA to issue new rules, guidance documents, and strategies. January 4, 2012 was one of the big due dates, because many new changes were supposed to be implemented by that date. The FDA released a One Year Progress Report to Congress in early January.

Many of those changes have not taken place. These are the guidelines and strategies benchmarks that the FDA has missed:

1. Guidance documents on updated Good Agricultural Practices issued for producers and importers of fruits and vegetables.
2. Guidance documents about how to protect against and prevent intentional food adulteration.
3. National Agriculture and Food Defense Strategy prepared with the USDA and the Department of Homeland Security.
4. Issue guidelines, along with the Department of Education, to manage and control the risk of food allergy in schools and early childhood education programs.
5. Designate and list high risk foods that need additional record-keeping.
6. Set up five Integrated Food Safety Centers of Excellence through the Centers for Disease Control, headquartered at designated state health departments.
7. Develop posting requirements for grocery stores when recalls are announced, including a list of acceptable conspicuous locations.
8. Issue guidance for importers in developing their foreign supplier verification programs.
9. Complete a study about the need for a unique ID number for every food processing facility and import broker.
10. Publish guidance for small business exemptions from Hazard Analysis and Risk-Based Preventative Controls (HARCP) requirements.

The FDA has implemented these goals:

1. Issued interim final rules on criteria for administrative detention of tainted or adulterated food.
2. Issued guidance to the seafood industry on food safety hazards.
3. Issued guidance to the dietary supplement industry about new ingredients.
4. Conducted outreach to stakeholders for input about developing preventive control rules.
5. Established the Produce Safety Alliance.
6. Established the Food Safety Preventive Controls Alliance.
7. Met the mandate for foreign food safety inspections.
8. Continued to build state/federal and global partnerships.
9. Launched a consumer-friendly web page for food recalls.
10. Announced a fee schedule for FY 2012.
11. Launched product tracing pilots through the Institute of Food Technologists.

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