Surprise: United, PMA on the rarely raw exclusion

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

Tom KarstNever been this blue, never knew the meaning of a heartache.”

Never, that is, until the Chiefs fell painfully short against the hated Denver Broncos on Sunday night.

Now back to the real, non-delusional produce world.

Specifically, let’s look at the public comments that have been received on the produce safety rule. At www.regulations.gov,  the FDA says it has received 11,978 comments so far. The produce safety rule  comment period has been extended by a week, to Nov. 22.

Oddly, though the site says it has received nearly 12,000 comments, only 300 or so have been published on the site.

Meanwhile, the preventive controls rule docket  shows that 5,400 plus comments have been received so far, but displays only about 259 comments. Like the produce safety rule, the comment period for the preventive controls rule was extended through Nov. 22.

The United Fresh FSMA page provides the United Fresh comments on the produce safety rule and the preventive controls rule for food facilities. The full United Fresh comments on the produce safety rule can be found here while the United Fresh comments on the preventive controls rule can be found here.

The Produce Marketing Association also furnished links to their comments about the food safety and preventive controls rule. The full comments from PMA on the produce safety rule can be found here, with the PMA’s comments on the preventive controls rule here.

One element of the comments from both groups that somewhat surprised me was the approach the industry associations took toward the FDA’s proposed exemption for commodities rarely consumed raw. In the proposed rule, the FDA exempted (from the produce safety rule) 37 commodities that are rarely consumed raw, including asparagus, potatoes and artichokes. That was a no go.

 

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.

 

From PMA’s executive summary of the produce rule, agreement:

 Produce rarely consumed raw exclusion: PMA opposes the use of a list of exempted commodities based on consumer preparation for consumption and recommends that this exemption be eliminated. PMA does not support the approach of using a commodity-specific list of exempt products based on currently likely means of consumer preparation and consumption for produce commodities.

 

 

 

I have to say I’m surprised with the comments from the national association on this point, though I understand their argument generally against exemptions and exclusions. I haven’t seen comments from the National Potato Council yet on the FDA’s proposed produce rule, but I have to believe those comments will differ in substance from what we hear from PMA and United Fresh.



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