Tom Stenzel, United Fresh Produce Association
Tom Stenzel, United Fresh Produce Association

What would you do to make the Food and Drug Administration’s draft rules under the Food Safety Modernization Act most effective in protecting public health and most workable for your business?

That’s the enormous question that United Fresh and our members have been grappling with since January.

It hasn’t been easy as these are complex rules intended for a very diverse industry, but there is nothing more important than food safety for fresh produce.

On Nov. 15, United submitted nearly 100 pages of comments on FDA’s first two proposed FSMA rules: the Produce Safety Rule and the Preventive Controls Rule.

Our comments were developed through extensive meetings and discussions among two expert working groups representing members from every segment of the industry.

Our goal was to provide FDA with real-world information about produce industry practices and how the proposed regulations can help enhance public health without creating unnecessary burdens for the industry.

United Fresh raised several key issues.

One-size-fits-all approach

While FDA has shown a willingness to recognize different risk profiles by proposing exemptions for thermally processed fruits and vegetables and certain commodities rarely consumed raw, FDA fails to take into account the potential for substantive differences in risks inherent in different produce commodities.

By applying the same standards to all crops without allowing for commodity differences, FDA unnecessarily adds significant economic burdens on some producers with no impact on risk reduction.

United recommends that FDA move all quantitative metrics into accompanying FDA guidance documents.

This has been a successful approach with the Seafood HACCP rule, in which one regulation must cover a wide diversity of products.

Irrigation water testing

The Produce Safety Rule proposes specific arbitrary metrics, target organisms and testing intervals for irrigation water that are not based on sound science and differ from other world regulatory standards.

United’s comments communicate the scientific uncertainty underlying such requirements, and emphasize that the risks and appropriate standards for irrigation water differ significantly among fruit and vegetable commodities.

Therefore, such metrics should be addressed in companion guidance that can be tailored to specific commodities as needed and updated when science is better informed.

Alternatives and variances

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

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