The FDA has announced that it does not intend to enforce certain provisions in four of the rules that implement their Food Safety Modernization Act (FSMA). One of these provisions directly affects cotton gins. TCGA and other cotton organizations have been arguing for some time now that gins do not provide any food related processing activities in their operations. TCGA staff and representatives from NCC, NCGA, and other regional organizations met with FDA officials late last year in Alabama to tour a cotton gin and discuss this issue.
On Thursday, FDA issued guidance that included language specifically referencing cotton gins. In the guidance, they point out that cotton gins meet the definition of “secondary activities farms” if they are primarily owned by a farmer or farming operation. They further state that they will consider all cotton gins to be “secondary activities farms”, regardless of ownership structure, pending a final rule. They also state that their enforcement discretion has been extended to any operation that is dedicated to harvesting, packing and/or holding Raw Agricultural Commodities. In this discussion, they specifically list cotton gins in this group.
In this guidance, they discuss two different mechanisms by which they can fix our issue with the FDA rules. This is very good news, and while our issue will not be fully resolved until the final rule is issued, this guidance is a major statement by FDA that they are committed to fixing our issue.
In the final analysis, we believe this guidance means that we need to keep our registrations up to date with FDA, but we no longer have a deadline to implement the animal food preventative controls requirement. This is a big step from FDA, and we will keep you informed as this issue progresses.