The Food Safety Modernization Act (“FSMA”) grants the FDA broad powers to make and enforce regulations aimed at preventing microbial contamination of produce and other food products at all points in the chain of distribution, from “farm to fork.” The statute, passed in 2011, has generated massive debate within the agricultural community about how best to protect consumers from food-borne illnesses without imposing unnecessary burdens on small farms, organic farming operations, community farming cooperatives, and other small agricultural businesses.
In response to an unprecedented outpouring of public comment on its initial draft rules, the FDA issued revised draft rules concerning key provisions of the FSMA in September 2014. The comment period for those revised proposed rules closed on Monday, December 15, 2014, drawing more than 110,000 comments from interested parties. The revised proposed rules made significant changes important to organic farmers and small farming businesses, but the many comments submitted concerning these revisions suggest that these interest groups feel there is still significant work to do.
One major point of contention in the initial rulemaking was the FDA’s requirement of a minimum interval between the application of compost or raw manure to produce as fertilizer and the harvesting of the fertilized produce. The minimum application interval rules drew criticism from organic farming operations, who asserted the intervals were not supported by scientific data and would discourage sustainable, “green” farming practices. In response, the FDA’s revised rule wholly eliminates the proposed 45-day minimum application interval for produce fertilized with composted manure, and defers any final decision on the proposed 9-month minimum application interval for untreated manure fertilizer until the FDA can collect additional scientific data on this issue. Overall, these revisions were applauded by organic farmers and consumers.
But small farmers and farming co-ops remain unconvinced that the FDA has gone far enough in its revision of another key regulation. The “Preventive Controls Rule” applies to facilities that process food for distribution. The FDA allows an exemption for farms that engage in minimal packing or direct retail activities. The original proposed rule only extended this exemption to farms that handled their own produce. In response to criticism from farming cooperatives and other small farmers who did “packing” activities for produce owned by another entity, the FDA revised its proposed rule to clarify that it does not matter who the owner of the produce being packaged is; the activities a farm can perform include packing and labeling raw produce.
Advocacy groups say this clarification does not go far enough because it fails to eliminate geographic limitations on the definition of the term “farm” that do not reflect the realities of cooperative farming and other common arrangements between small local growers. As revised, the definition of “farm” remains limited to “an establishment under one ownership in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.” Proposed 21 C.F.R. § 112.3(c). The FDA has received many comments to the revised proposed rule, requesting that the “one general physical location” requirement be eliminated or modified to clarify that many farms are not contiguous and that many farming operations rent or borrow space offsite to perform packing and other traditional farming activities.