FDA Delays FSMA Rule for Gins – Indicates Rewrite Coming

Late last week the Food and Drug Administration (FDA) published a guidance document that further delayed the implementation of the Food Safety Modernization Act changes to FDA Rules for several types of businesses including cotton gins. In the guidance, the FDA said that businesses that would normally be considered a farm in the rule except for their ownership would have the rule delayed until a new rule can be written.

The current rules say that if a gin’s ownership bring more than half the cotton to the gin, it would be considered a ‘secondary activities farm’ but if the majority of the cotton came from producers that weren’t owners, they were not a farm and therefore would be subject to the rule. The guidance released last week indicates that the FDA will not be enforcing the FSMA rules on these facilities for the time being.

The guidance also goes on to discuss a number of other facilities that have similar issues to those that we had brought up and that they were exercising enforcement discretion for those facilities as well. The documents say a new rule is going to be promulgated but this enforcement discretion will give them plenty of time to write a proper rule. They indicated it was not their intent that some businesses be treated totally differently just because of the ownership or a insignificant activity that the business did.

In addition to the Guidance, FDA also published a Fact Sheet and Constituent Update. All this means that for the foreseeable future, we will not be subject to the FSMA rules.