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Who Controls The Hazard?


Who Controls The Hazard?

At core of the Food Safety Modernization Act is the requirement to control hazards through preventive means. However, who or where in the supply chain those controls are implemented can have substantial implications, especially on distributors, that even FDA hadn’t anticipated. I’m referring to 21 C.F.R. 117.136, a section of FDA’s Hazard Analysis and Preventive Controls rule that provides a manufacturer the ability to rely on their customers, such as distributors, to obtain and maintain certain records regarding preventive controls not implemented by the manufacturer. 

What this Section provides is an exemption for food manufacturers from the requirement to implement a preventive control for an identified hazard, if the manufacturer can demonstrate and document that the identified hazard will be controlled by another entity downstream in its distribution chain – meaning the receiving facility or downstream customer. So, in effect, the exemption allows the manufacturer to delegate control of the hazard to someone else further down the supply chain.

To implement this exemption, a manufacturer must do two things: (1) notify foodservice distributors that they have not processed the food to control an identified hazard – such as a disclosure in the shipping documents accompanying the food that the product is not processed to control identified hazards; and (2) annually obtain from each distributor a written assurance that the distributor will (a) disclose that the food is not processed to control the hazard, and (b) will only sell the food to entities that agree in writing that they will control the hazard or will obtain similar written assurances from their customers.

Since most distributors are not engaged in processes that would control a hazard other than temperature control, the distributor would then have to obtain promises or guarantees from the restaurants they supply that their processes will eliminate the hazards, such as cooking to proper temperatures to kill bacteria.

I believe that most restaurants would not sign such documents nor would distributors want to maintain the records that would be associated with such annual written assurances. We strongly recommend that if distributors receive such requests or disclosures from manufacturers, they not sign-off to accept that responsibility. I am happy to assist any distributor in addressing this issue with their manufacturers if faced with this burden, as we believe that existing labeling laws already instruct customers on how to control food hazards such as in the declaration of allergens, handling and cooking instructions, etc.  

The overall impact of this section has huge implications for distributors, but has gone relatively unnoticed since these provisions were not part of the proposed rules and were only added after the comment period. Apparently FDA feared that product that might have originally been intended for one purpose that would include a control could wind up being used for another purpose that may not include a control. And, although FDA’s intentions to strengthen the rule may have merit, the burden placed on downstream customers was not anticipated.    

Industry associations, such as IFDA and GMA, who did not get the opportunity to comment on these provisions are now actively engaged with FDA to seek an industry acceptable resolution. Fortunately, FDA is listening and is examining how to best address this issue. Without a more practical solution, 21 C.F.R. 117.136 as currently written will create significant challenges for foodservice distributors. In the interim, we urge you to resist taking on this responsibility and support industry associations working on our behalf.  

Provided by Bob Salo, UniPro Departmental Vice President Food Safety & Quality Assurance

- Written Assurances under 21 CFR 117.136 - August 8, 2016 

For more specifics about section 117.136 see: