FDA Issues Food Safety Rules
FDA Issues Food Safety Rules
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I’m catching up with events that occurred while I was out of the country. One was the release by FDA of two of its long-awaited proposals for food safety rules.
These go into the Federal Register on January 16. But they were announced on January 4, perhaps to commemorate the two-year anniversary of President Obama’s signing the Food Safety Modernization Act authorizing these rules.
The two massive sets of proposed rules, 680 and 547 pages, respectively, are:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
- Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Still to come: proposed rules for
- Food importers
- Preventive controls for animal feed
- Accreditation of third-party auditors
Notice that all of these are proposals. Terrific as it is to have them released, no breath-holding is in order.
Once the proposals appear in the Federal Register, interested parties will have 120 days to comment. It will probably take a year for the FDA to write final rules. For the produce standards at least, larger farms get 2 years before implementation kicks in. Smaller farms get 3 or 4 more years to figure out how to comply.
Some farms, such as those bringing in less than $500,000 per year, are exempt. Chalk that up to successful lobbying by small farmers.
The FDA estimates that the new rules will cost large farms about $30,000 a year, and small farms $13,000. It says that following the rules will prevent 1.75 million cases of foodborne illness a year and save more than $1 billion in costs.
The rules for produce focus on prevention of contamination through:
- Agricultural water
- Biological soil amendments
- Poor worker hygiene
- Domesticated and wild animals
- Equipment, tools and buildings.
All food producers will need to develop, submit, and follow a written food safety plan that includes:
- A hazard analysis
- Preventive controls
- Monitoring procedures
- Corrective action procedures
- Verification procedures
- A recall plan
That’s the basic outline. The devil is in the details and in this case there are plenty of them (I have much sympathy for whoever has to write these things). The proposals devote hundreds of pages to definitions.



