New FDA Food Safety Rules Proposed – Food Safety Modernization Act

By Taylor Reid

On Friday, January 4th 2013 the FDA issued two new proposed rules regarding “food safety standards“. The new rules are the first step in implementing the the controversial Food Safety Modernizaton Act, or FSMA, which was signed into law in January of 2011.

The first proposed rule regarding  “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food”  would require non-exempt* “facilities” Establish and implement a food safety system that includes a hazard analysis and risk-based and implement preventive controls.

This rule as proposed would establish requirements for: 1)A written food safety plan; 2)Hazard analysis; 3)Preventive controls for hazards that are reasonably likely to occur; 4)Monitoring; 5)Corrective actions; 6)Verification; and 7)Associated records.

Exempt “facilities would include” 1) Businesses with average annual sales of less than $500,000 per year for whom at lease half of all sales are direct to consumers or “local” retailers & restaurants. “Local is defined as within the state or within 275 miles or2) Low risk, on farm activities performed by a small business. For a more detailed description of these exemptions, and to read the rule in full, go to

The second proposed rule would “establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption”. This rule too would include exemptions. Farms that have an average annual value of food sold during the previous three-year period of $25,000 or less would be exempt. And there would be a “qualified exemption and modified requirements” for farms that: 1) have food sales averaging less than $500,000 per year during the last three years and 2) sell more than 50% of their products directly to consumers, or to “a restaurant or retail food establishment that is located in the same State as the farm or not more than 275 miles away” (Instead, these farms would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing or at the point-of-purchase. For detailed information on this rule see the Federal Register Notice for the Proposed Rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.

Comments about the proposed rules may be given by mail or electronic submission according to the guidelines in the Federal Register announcements/PDF’s above. You can also find the full text of FSMA itself here: FDA Food Safety Modernization Act (FSMA)

Contrary to much of they hype that surrounded the implementation of the Food Safety Modernization Act, these proposed rules do not make home gardening or organic agriculture illegal. But they do place new burdens on many food producers.

Below you can see more detailed analysis of the new proposed rules from the National Sustainable Agriculture Coalition:

For Immediate Release: NSAC Statement on FDA Release of Food Safety Rules – Today, the Food and Drug Administration released much-anticipated proposed rules detailing standards for produce safety and preventive controls for human food production.  Releasing these rules is a major step in the implementation of the Food Safety Modernization Act (FSMA), which President Obama signed into law two years ago.  The law is the first significant overhaul to our nation’s food safety laws since the 1930s.  Read more…

FDA Releases Food Safety Regulations – Today, the Food and Drug Administration (FDA) released two major proposed rules detailing standards for produce safety and preventive controls for human food production.  FDA is also requesting comments on its draft risk analysis on activities conducted in a facility co-located on a farm.  Read more…

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