H.R. 2749 would require FDA to issue regulations creating a “tracing system for food” to enable FDA to identify each person who grows, procures, manufactures, processes, packs, transports, holds or sells an article of food within two business days. S. 510 would require FDA to establish a product tracing system within FDA to improve the agency’s capacity to effectively and rapidly trace food.
The associations will continue to work with Congress to improve the potentially harmful provisions of the bill until it is voted on, which, at the time of this writing in late September, is predicted to be as late as sometime in early 2011. However, the U.S. legislative process is fluid in nature and at any point S. 510 may continue to move forward.
Sidebar: RFR Fails to Recognize Feed Industry Practices
Beginning in September of 2009 the FDA began requiring all food and feed facilities to report contamination incidences through its electronic portal, the Reportable Food Registry (RFR). The intent of the RFR is to further enhance food and feed safety by expediting the FDA’s ability to trace adulterated products that meet the reporting threshold of posing “serious adverse health consequences or death” to humans or animals.
Randy Gordon, National Grain & Feed Association vice president, communications and government relations, said as of early September, only 18 feed-related incidents have been reported. Seven of those involved microbial incidents, six involved physical hazards (such as metal, glass, etc.), and five involved formula or mixing errors.
However, certain definitions contained in the FDA’s draft guidance of the RFR are not practical in the context of a feed or grain operation. Its definitions of “transfer” and “microbial contamination” especially demonstrate the FDA’s lack of knowledge of common feed industry practices.
Feed associations have been working with FDA officials over the past several months to address their concerns over these issues. The American Feed Industry Association (AFIA) filed formal comments on July 21 and The National Grain & Feed Association (NGFA) and National Oilseed Processors Association (NOPA) submitted a joint on that same date suggesting several changes.statement suggesting several changes.
“Transfer:” NGFA noted that FDA’s current interpretation deems that a load of corn has been transferred to a feed mill once a rail car has been decoupled from a locomotive and is on the feed mill’s rail siding, even though the corn has not been inspected to determine if it conforms to contract specifications — included for product safety — and later may be rejected back to the supplier. Likewise, the agency has considered products to have been “transferred” to another party if they are moved via a common carrier (truck, rail car or barge) not owned by the shipper’s company, or if it is stored in a third-party warehouse, even though the company or facility has the ability to retrieve the product and prevent its distribution into commerce.
“FDA needs to change its thinking on what ‘transfer’ means,” said Sellers. “That definition must be predicated upon legal ownership and legal responsibility for the food product or ingredient in question,” he added.
“The feed industry, as well as most other parts of the food industry, routinely sample and test ingredients prior to taking legal ownership. To contend a trailer left by the ingredient supplier for testing shifts responsibility for reporting a contaminated load doesn’t recognize common feed/food industry quality/safety assurance practices, and is inconsistent with earlier FDA statements,” said Sellers.
Recognizing that its interpretation conflicted with industry practices, the FDA sought public comment on the meaning of “transfer.”
NGFA and NOPA urged FDA to change its interpretation as to when products are considered “transferred” to conform to common commercial trade practices. Specifically, they urged that transfer be deemed to have occurred when the receiving facility has “ownership, acceptance and control” of the product. The NGFA-NOPA position also was mirrored in comments submitted by the Grocery Manufacturers Association and Pet Food Institute.