John Block Reports: FDA – Coming to a Farm Near You

OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block on John Block Reports.

Just last week, marking the second anniversary of Congress’s passage of the Food Safety Modernization Act, FDA proposed comprehensive regulations for the growing, harvesting, packing, and holding of produce. FDA acknowledged this is the first effort by the agency to regulate the produce farming community. While not the first time FDA has been on the farm, the FSMA proposal represents the agency’s most ambitious and comprehensive effort to regulate the safety of farm produce.

The proposed rule covers only biological hazards – for example, pathogens. Chemical hazards will remain under the jurisdiction of EPA.

Not all produce will be covered. Produce not customarily eaten raw – for example, sweet corn, sweet potatoes, and white potatoes or frozen foods – and produce customarily sent for commercial processing, which would include canning, are exempt.

  • Grains are also exempt.
  • Sprouts are covered and subject to special production, testing, and recordkeeping requirements.

Significant new requirements imposed by the proposed FDA regulations include:

  1. Water sources would have to be tested periodically for pathogens, including listeria, salmonella, and E. coli O157:H7.
  2. Covered farms would be required to “monitor” for wild animal intrusions and not harvest in areas of the farm where there is evidence of such activity.
  3. Workers suffering from contagious diseases would be excluded from field or handling work.
  4. Farmers would be required to provide training to all workers, including seasonal workers, on principles of food safety, the importance of personal hygiene, and the requirements of FDA’s produce safety rule. Each farm would be required to have a supervisor who has received FDA-recognized (certified) training.
  5. There are specific requirements for equipment, tools, and buildings as well as record creation and record access provisions.

While clearly well-intended, FDA’s proposal could be a costly nightmare for covered farming operations. The “wild animal contamination” and “employee training requirements” will be quite difficult to implement, and costly. Many older or smaller farms will need to retrofit their operations to comply with the building, equipment, and tool requirements.

Another rule covering animal feed is expected soon.

The public is given 120 days – until mid-May – to comment. Farmers and farm groups should educate themselves on this proposal and make sure FDA hears from them before it’s too late.

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