Ever since the Food Safety Modernization Act was signed into law in 2011, there has been substantial uncertainty and anxiety around how FSMA regulations will affect produce businesses.

One key concern has been where the Food and Drug Administration will draw the line to determine which produce businesses are covered by the Produce Safety Rule and which will be covered by the Preventive Controls for Human Foods Rule.

Unfortunately, when the final regulations were published, we ended up in a strange situation where some produce packinghouse operations were regulated by the Produce Safety Rule, while others were regulated by the PC Rule based on who owned the packinghouse.

It's hard to understand how this can be risk- and science-based given that such businesses - regardless of who owns what - are performing exactly the same activities.

The FDA has done a great job listening to produce industry concerns. We have a lot of unique challenges in our food industry segment and have worked with FDA toward solutions.

Yet, the outstanding issue remains that the exact same activities are being subject to different rules purely based on location or ownership requirements.

FDA has tried hard to address this issue by constructing a broader definition of "farm" to accommodate as many produce businesses as possible in the Produce Safety Rule.

The Produce Marketing Association and the United Fresh Produce Association applaud these efforts.

Many produce businesses, however, find the revised "farm" definition so convoluted and unclear it's impossible to understand which rule applies to their operations and therefore implement the rule with confidence.

This inability to easily understand whether or not a produce business meets the FDA definition of "farm" - and hence determine which FSMA rule it falls under - has created fear and anxiety of regulatory jeopardy in the produce business community.

FDA recently published draft guidance to industry intended to clarify when specific activities do and do not fall within the FDA definition of "farm." The mere need for this guidance illustrates the complexity of the current "farm" definition.

Additionally, FDA guidance is still pending regarding key aspects of the definition of "farm," such as what is meant by "under one management" and "in one general (but not necessarily contiguous) physical location."

This complexity and lack of specificity means FDA will have to help produce businesses on a case-by-case basis figure out what rule they fall under.

Given the extraordinarily large number of firms involved, this approach is clearly unworkable for businesses and overly burdensome for FDA.

A simpler approach

More guidance to clarify complex rule definitions is only digging a deeper hole for FDA and the produce industry. In response to this recent draft guidance, PMA, United Fresh and other leading produce trade organizations have jointly filed comments on behalf of our members urging FDA to consider a simplified, alternative approach.

In our comments, we encouraged the agency to consider our proposal that foods meeting the definition of "produce" and "raw agricultural commodities" that remain the same product in commerce during postharvest handling be subject to coverage by the Produce Safety Rule, irrespective of where they are grown, harvested, packed or held.

This commonsense approach means if a whole tomato remains a whole tomato after going through a packinghouse operation, this operation would be covered by the Produce Safety Rule, irrespective of where that occurs.

If that whole tomato is sliced or diced into a fresh-cut product, it has been substantially changed, meaning it is a different item because of processing and would be subject to the PC Rule.

This clear distinction between coverage of the Produce Safety Rule and the PC Rule would strengthen enforcement and reduce confusion for produce businesses and regulators alike.

It would also provide uniform and effective regulation of all postharvest activities, irrespective of where those activities take place.

In the comments, we also expressed our readiness to work with FDA and Congress, if need be, on a solution should the problem stem from how the FSMA statute was written.

The split regulatory system FSMA unintentionally creates simply fails to reflect the realities of produce production and handling and, ultimately, fails to best serve public health.

PMA and United Fresh will continue to take every step we can to voice these concerns on behalf of our members. We remain committed to advancing produce safety in ways that are practical for the fresh produce industry.

You can bet the farm on it.

Jennifer McEntire is the United Fresh Produce Association's vice president of food safety and technology. Jim Gorny is the Produce Marketing Association's vice president of food safety and technology.

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