Tom Stenzel, United Fresh Produce AssociationWhat 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.
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