November 1, 2005
Broken Case Clarified
Previous editions of this newsletter have dealt with record keeping requirements in the context of food product recalls. Your editors have asked me to dig a little more deeply into some discrepancies in this area regarding meat and poultry products versus other food items, particularly from the perspective of the distributor who might be handling and breaking cases containing both types of product.
There are some important differences. As you know, issues of meat and poultry product safety, including recalls, are handled by USDA while problems with other foods are handled by the FDA. FDA’s recordkeeping requirements have recently been updated through regulations which implement the Bioterrorism Preparedness and Response Act of 2002. Among other things, these regulations require distributors to maintain records identifying the lot or code number or other identifier of foods that they release to subsequent recipients if that information exists. As a practical matter this means that a distributor opening a case of coded, FDA-regulated product will need to keep records documenting, through reference to the case code, the identity of all of the customers who have received the contents of the case.
The Bioterrorism Act, however, does not apply to the meat and poultry products regulated by the USDA. In fact, many of the major provisions of the law, such as the requirement for the registration of manufacturers, were thought to be unnecessary, given the existence of USDA’s more extensive inspection system.
The net result, however, is that USDA recordkeeping requirements have not been updated in a similar fashion. As a result, the USDA requirements remain more general and do not include any specific requirement that a distributor maintain code identity of the meat and poultry products he distributes once a case has been broken.
While maintaining this level of traceability is therefore not a specific regulatory requirement for meat and poultry handlers, there are still a number of good reasons why it might be a good idea to initiate the practice across the board. First of all, if you need to adjust your system to make sure it has such capability for other products, it is probably more efficient to do so for meat and poultry at the same time, particularly since there is a good chance that USDA will eventually adjust its own regulations in the same way. Second, in any future recall situations it is going to facilitate your dealings with regulators if you have this type of information available. And finally, above and beyond any regulatory questions, there is the more open ended issue of potential civil liability. Over time it could well be argued that the coding requirements in the FDA regulations have established a new basic norm for the food distribution industry. If I were a distributor facing a situation where someone had gotten sick after consuming a meat product I had distributed, I might be able to draw some of the same regulatory distinctions discussed in this article, but I am not sure how persuasive they might prove to be to the average member of a jury.
As in other parts of life, in recalls and other regulatory situations, first impressions matter. You want to put yourself in a position in any dealing with a regulator to demonstrate efficiency, cooperation, and full compliance as quickly as possible. The sooner you can do so, the sooner the process will be over and you can get back to your business.
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