FSMA anticipated that differences among commodities, growing regions and practices would require some flexibility in application of appropriate regulatory standards.
While FDA attempts to address this need with sections proposing two specific avenues for “alternatives” and “variances” to the rule’s requirements, these opportunities are unnecessarily restricted and not likely to be effective as proposed.
United proposes revisions to allow science-based alternatives to address any of the risk factors, and variances that can be submitted by any knowledgeable body such as associations and commodity boards.
Definition of farm and farming
The two proposed rules include a new regulatory term, “farm mixed-type facility,” designating operations that would have to comply with the Produce Safety and Preventive Controls rules.
United thinks this designation is overly complicated and not risk-based, and would have severe economic consequences without enhancing public safety.
FDA has inadvertently grouped very low risk produce packing and warehouse facilities together with food processing facilities, which require very different food safety practices.
United submits that packing and holding raw, intact fresh produce is covered adequately by compliance with the Produce Safety rule, regardless of the size of the operation, the owners of the produce handled or the distance from where the produce was grown.
Revised proposed rule
United strongly supports the recommendation of the National Association of State Departments of Agriculture that FDA publish a second round of proposed rules so that all stakeholders can review and comment on these changes before they are finalized.
United Fresh strongly supports the public health mission of the FSMA law and we are dedicated to continue our work with FDA to ensure that these landmark regulations are implemented in the most practical and efficient way.
Tom Stenzel is president and chief executive officer of the Washington, D.C.-based United Fresh Produce Association. Read United’s complete comments to FDA on the Produce Rule and Preventive Controls Rule at www.unitedfresh.org/fsma.
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