The proposed rules are detailed and complex, but they ultimately provide little practical guidance to farmers and food processors. Instead, the rules give FDA broad discretion to make case-by-case determinations as to whether a business has adequately controlled food safety risks.

For example, the proposed rules include provisions to prevent contamination of produce by waste from wild and domesticated animals. The rules state that if there is a “reasonable probability” that grazing domesticated animals will contaminate crops, then a farmer must implement an “adequate waiting period” before harvest. See Proposed Sec. 112.82. The rule does not define “adequate waiting period,” but FDA’s commentary on the proposed rules states that FDA “would not expect it to be necessary” for the waiting period to exceed nine months. The proposed rules therefore give FDA discretion to dictate grazing and harvest schedules on farms utilizing both livestock and planted crops. This could be particularly problematic on organic farms that utilize chickens or goats for weed control.

Another related issue concerns discrepancies between FDA’s explanation of its rules and the actual text of the rules. For example, the proposed rules forbid the distribution of “produce that drops to the ground before harvest” unless the produce is subsequently treated to prevent contamination. Sec. 112.114. FDA asserts that this rule does not apply to tree nuts and other crops that are “dropped to the ground as a part of the harvesting practice.” The dropped produce rule, however, plainly applies to any produce that hits the ground before it is harvested. Unless amended, therefore, this rule could force changes in the production of crops such as Oregon hazelnuts that are harvested from the orchard floor after the nuts have naturally dropped to the ground.

Finally, the proposed rules contain intensive monitoring requirements and harsh consequences for the discovery of perceived food safety risks. For example, the proposed rules regulate all irrigation water that could come into direct contact with produce. Farmers using such water must test the water for E.coli bacteria every three months during the growing season and must immediately discontinue water use if any E.coli is found in the water. This requirement applies even when a growing crop will be subsequently washed or processed to eliminate bacterial contamination. A farmer may not resume irrigation until the farmer treats the water source or can prove that E.coli is no longer present in the water and is not likely to return. See Sec. 112.44-45.

The Portland meeting will provide an important forum for Northwest farm businesses to provide feedback to FDA on the proposed rules. FDA has little experience with agriculture and needs information about how its ideas will affect actual farms and farm businesses. Those unable to attend the public meeting may submit written comments to the FDA by May 16, 2013.