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FDA Issues Massive Food Safety Regulations -- Holds Stakeholder Meeting

January 4, 2013

On the same day the Food and Drug Administration (FDA) released pre-publication versions of two of its major food safety proposed regulations under the Food Safety Modernization Act (FSMA), the agency held an industry stakeholder meeting to discuss the rules’ science-based standards for the prevention of foodborne illnesses.  During the call, key FDA representatives--Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor, and Donald Kraemer, Senior Advisor at the Center for Food Safety and Applied Nutrition--gave overviews of the Preventative Controls and Produce Safety proposed rules. 

During the call Taylor and Kraemer did not directly address the massive cost burden estimates in the proposed rule but emphasized that the rules followed the Congressional mandates of FSMA and that both rules will have staggered dates for implementation and compliance based on whether the industry would fall into a category of large, small or very small facility or farm.  Mr. Kramer spoke primarily as to the highlights of both of the rules but also addressed the proposed rules’ coverage by stating that the Preventative Controls proposed rule applies to all registered food facilities other than  facilities already subject to standing hazard analysis and critical control points (HACCP) requirements for seafood, juice and low acid canned foods. Dietary supplement facilities and raw agricultural commodity facilities such as grain storage and warehouses that store packed foods that are not exposed to the environment, are also exempt.  The Produce Safety proposed rule applies to both domestic and imported foods with an exemption for small farms (average sales that on a rolling basis, average annual monetary value of food sold during the previous three-year period is less than $25,000).

The Preventative Controls proposed rule would require makers of food to be sold in the United States, whether produced at a foreign or domestic based facility to develop a formal plan for preventing their food products from causing foodborne illness as well as develop a corrective action plan when problems arise.  During the conference call Mr. Kramer specified that this proposed rule is primarily risk-based and that industry will need to draft food safety plans that adjust to the nature of the hazard as different food types have different hazards associated with their production.   The Preventative Controls proposed rule focuses heavily on updates for both HACCP and GMP requirements. In terms of HACCP the list has become broader to include sanitation controls while the good manufacturing practice (GMP) requirements were updated to take into account allergens by paying greater attention to not only cross contamination but also cross contact.  The FDA is proposing that large food manufacturers be in compliance with the new preventative controls rules one year after the final rule is published but small and very small businesses would be given two and three additional years respectively to comply.

The Produce Safety rule would require farms that grow, harvest, pack or hold fruits and vegetables to follow standards that are aimed at preventing contamination. The FDA defines produce to mean any fruit or vegetable (including mixes of intact fruits and vegetables), mushrooms, sprouts (irrespective of seed source), peanuts, tree nuts and herbs, though produce for personal on-farm consumption would not be covered.  Leafy greens, oddly enough, are also not covered by produce safety rule, but will be covered by the Preventative Controls proposed rule. Included in the proposed rule are several suggested water testing standards that are risk based on the manner in which the water is applied.  Mr. Kramer explained that in cases where irrigation is applied directly to the edible portion of a crop such as spray irrigation, there is a suggested standard but in cases where irrigation is applied in a drip on method the water would need to meet a more general requirement that addresses basic safety and overall quality.  He went onto state that the FDA is still proposing definitions for small and very small farms in terms of compliance dates but that the implementation dates will be staggered for the date of the final rule to two years for large farms, three years for small farms and four years for very small farms.

The issuance of these proposed rules marks the start of what will be a lengthy and challenging rulemaking proceeding.  Public comments will be due 120 days after publication in the Federal Register.  Wiley Rein’s Food & Drug Practice includes seasoned attorneys with FDA experience, including in the development, implementation, and enforcement of FDA’s food safety policies.  We will be issuing detailed analyses and recommendations based on the proposed rules and invite affected companies to confer with us regarding options for ensuring your views are fully considered by the FDA as it works to finalize the regulations.