Surprise: United, PMA on the rarely raw exclusion

11/18/2013 12:32:00 PM
Tom Karst

 

From the United Fresh comment:

Exemptions Based on Processing/Consumer Cooking

We are also uncomfortable with the concept of any fruits and vegetables being wholly exempt from the rule, under the same philosophy that the public expects FDA has provided for appropriate regulatory oversight of ALL fruits and vegetables. Rather, we propose an approach similar to 21 CFR part 123, the Seafood HACCP rule, which provides for regulatory oversight of the diversity of all seafood, coupled with companion Guidance that addresses specific variability appropriate to different products. This approach would provide for the comprehensive regulatory oversight of all commodities that both FDA and industry desire, with the ability to target appropriate specific practices and metrics to individual commodities or commodity groupings as contemporaneous science and experience mandates. In fact, this approach to combine broad regulatory oversight with specific guidance that can better differentiate risk management needs among different commodities is the approach that United Fresh recommends FDA take overall. We will discuss this in more depth later in these comments.

Within the context of Guidance, United Fresh would support modified requirements for fruits and vegetables intended to be thermally processed foods, or with another validated kill step sufficient to eliminate pathogens reasonably likely to occur. Such modified requirements should only be allowed if producers and processors can provide assurance that fruits and vegetables not grown according to standards in the rule cannot enter the fresh produce supply chain. This could require specific processing contracts that provide for control of raw products, and significant penalties to any person who diverts fruits and vegetables grown for processing into the fresh market.

Similarly, an “exhaustive” list of fresh fruits and vegetables being exempted because they are “rarely consumed raw” is not acceptable in the rule, but may be addressed appropriately in Guidance. While we agree that produce that is cooked by the consumer can achieve the same level of public health protection as any validated kill step, dietary practices and eating norms change. FDA is well aware of its mistake proposing that kale could be exempt as rarely consumed raw, when today it is the fastest growing vegetable in the United States often eaten raw in salads and in “healthy” beverages. Given that such a list in the regulation would be onerous for the Agency to amend, we believe such a list should be addressed as part of Guidance, allowing fresh fruits and vegetables to be added or deleted from the list as warranted by future information, without the necessity of rulemaking procedures. Further, consistent with our recommendations in the paragraph above, we believe that such a list be accompanied by a caution to handlers of such commodities that an exemption from the requirements of growing practices would be invalidated if the produce is marketed for fresh consumption.



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