Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes. FDA is currently exploring the extent to which cotton ginners should be covered by FSMA. Cotton farmers and ginners, of course, produce the fabrics that we use every day, but they also produce food. After being separated from fibers in a process called ginning, cotton seeds and cotton plant parts are frequently used to feed livestock. Cotton seeds may also be further processed into cottonseed oil and cottonseed meal for animal food.  Because products derived from ginning enter the American food supply, the cotton industry has raised concerns about the impact of the new FSMA requirements on cotton ginners.

As background, cotton ginning has traditionally fallen under the general food adulteration provisions of the Federal Food, Drug, and Cosmetic Act.  With the implementation of FSMA, certain operations are now also subject to the FSMA-mandated preventive controls requirements, which applies to manufacturing facilities rather than farms. Most cotton ginning is done by farms, whose ginning operations do not fall under the new requirements.  But cotton gins that are not part of a farm are considered manufacturers subject to the preventive controls requirements, which include a hazard analysis and the implementation of controls to minimize hazards.

In August 2016, FDA extended the compliance date for cotton ginners subject to the Preventive Controls for Animal Food rule to allow for additional time to consider how best FSMA should be tailored to cotton ginners (81 FR 57784). Under the extension, regular businesses have until January 28, 2019 to comply, small business until January 27, 2020 and very small business until January 26, 2012.  In the meantime, to better understand industry’s concerns, FDA officials recently traveled to northern Alabama to visit a cotton farm, ginning operation and a cotton warehouse.  In a recent FDA blog post, Dr. Stephen Ostroff, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, indicated that the Agency wishes to further engage stakeholders “in pursuit of a solution that works for industry while protecting public health.”