Regulatory Impact Analysis: produce safety rule - The Packer

Regulatory Impact Analysis: produce safety rule

01/11/2013 03:19:00 PM
Tom Karst

Over the entire six year time horizon, we observe 15 outbreaks and 769 illnesses attributable to leafy greens. Additionally, there are 9 outbreaks and 1,194 illnesses associated with tomatoes. These two commodities represent the highest number of  average annual outbreaks and illnesses in our available data.

After these top two commodities, herbs, with 3 outbreaks and 730 illnesses; melons, with 7 outbreaks and 313 illnesses; and sprouts, with 9 outbreaks and 151 illnesses, represent the most prevalent commodities in our outbreak data. These commodities are also a likely source of a significant portion of the estimated average annual burden of illness that this proposed rule aims to mitigate.

There are also commodities that appear relatively infrequently in this outbreak data. These include: peppers, peas, green onions, nuts, and berries, each with only one associated outbreak over the six year time horizon. Although these commodities appear to be lower in risk than other types of produce (such as leafy greens), they are subject to the same types of hazards as other produce.

The fact that an outbreak did occur during this time period confirms FDA’s understanding that all produce is subject to sporadic and largely unpredictable outbreaks and illnesses without appropriate mitigation steps. These commodities and their associated outbreaks, show that a variety of produce, that is not typically cooked or receiving kill step processing, even if it is not typically associated with foodborne outbreak may be vulnerable to occasional contamination to a degree that produces a widespread or lethal outbreak.

It considerably more difficult to project the extent to which benefits will be derived from preventing these, since due to their nature, they are unpredictable in the commodity, when they will occur, and the root cause of the outbreak. Therefore, it is uncertain that a regular pattern of outbreaks associated with these products will emerge. We believe that the proposed rule will prevent some meaningful number of these sporadic outbreaks and lead to reductions in human illness.


TK: The sales threshold of what farms should be exempt will be hotly discussed by the industry and small farm advocates. This long document merits a careful reading by the industry.

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