Big Changes in Final FDA Food Safety Rules

The Following is a reprint from the Texas Cotton Ginners Association newsletter written by Kelley Green. It is the most succinct summary of what we’re facing with the recently adopted FDA Food Safety Modernization Act rules.

As this final rule was just released last week, we are still trying to get our heads around the 400+ pages of the Food and Feed rules.


Big Changes in Final FDA Food Safety Rules

Cotton gins have been subject to the enhanced FDA food safety rules for some time now, but under an interpretation in the final rules, our requirements under this set of regulations just increased significantly.  As we have historically read the rule, we were covered as a facility that is “solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing.” 

Grain elevators are also covered under this section.  For these types of facilities, you have to register with FDA and keep track of your suppliers and your customers, but that is about it.  Unfortunately, when the final rule was issued, FDA inserted some clarifying language, and in that language they stated that cotton gins, like nut shelling operations, did not solely engage in the storage, but also performed a processing role.  If this interpretation holds, then we will have significant additional requirements.

This change was first brought to our attention through an NFGA contact, and the National Cotton Council Folks are working to get this clarified.  Our position is that we do not do any food processing.  We are processors of fiber for non-food purposes, and simply remove the fiber from the cottonseed for non-food purposes.  Cotton Ginning is an extension of the harvest, and there is no food or feed processing conducted at a cotton gin.  Gins perform a service of separating the lint from the seed while maintaining the inherent quality of both raw agricultural commodities.  Gins store the seed as a raw agricultural commodity for animal feed purposes.  The only food related portion of our business relates to the storage of cottonseed for further distribution.  We sometimes use aeration fans to cool the seed, as does a grain elevator, but that is the only type of seed processing that would ever occur at a gin.

If we are successful at making this argument, then we are back to our original position with FDA – that is gins have to register as a food facility but only keep track of their upstream and downstream customers.  If FDA’s current guidelines hold, then we are now subject to Subparts C and E of the rule.

Under Subpart C of the rule, each facility must prepare a Food Safety Plan.  This will include:  1) a written hazard analysis, 2) The written preventative controls required under this rule.  3) The written supply-chain program, 4) the written recall plan, 5) Written procedures for monitoring the implementation of the plan, 6) The written corrective action procedures, and 7) The written verification procedures.

Under the regulations, a facility is required to implement preventative controls to control a hazard as defined:  “A known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.”

As you can see, this plan may be quite complex, and it may be that a specialists will need to be hired to implement the plan.  The plan will have to be re-evaluated every three years.

Under Subpart E of this rule, you have to establish a supply-chain program for any ingredient for which the facility has identified a hazard requiring a supply-chain-applied control. This section should not be applicable to our facilities.

This rule will go into effect on September 19, 2016 for larger businesses.  Businesses with less than 500 employees have an additional year to implement the rule, and some very small businesses have two more years.

As you can see, this rule may become significant for cotton gin operations.  We are still working through the requirements of the rule, and we will keep you all informed as we dig through the details in this rule.