FDA’s second proposed rule – preventative controls for human food - would apply to facilities which manufacture, process, pack, or hold food grown in the U.S. and internationally for human consumption.

In general, this includes operations registered with the FDA under Section 415 of the federal Food, Drug, and Cosmetic Act.

The rule would require a hazard analysis and evaluation with risk-based preventive controls. The rule would tighten down on food allergen issues, sanitation, cross-contact and cross-contamination prevention, labeling, product recalls, and other areas.

Stenzel says many produce growers believe they would fall only under the produce rule, but in many cases would also have to follow the preventative controls regulations. If a farm has a packing shed or the produce is placed in a box, the grower must follow the preventative control regulations.

“This is a much more detailed and aggressive regulatory approach for our industry and for packing and warehouse-holding facilities,” Stenzel said.

“In the case of a packing shed for whole produce, these procedures are not necessary to protect public health. We will make this case to the FDA.”

Food manufacturing and processing facilities and the fresh-cut produce business already follow preventative control procedures as part of risk mitigation.