FOOD SAFETY

2010 proved to be a historic year for the food program at FDA. After a tumultuous ride through Congress, the Food Safety Modernization Act landed on the President’s desk in the last days of the year. It was the first full year that the Reportable Food Registry (RFR) was in operation and historically high numbers of food recalls continued.
The RFR was implemented in September 2009 as an “early warning system” with the goal of removing contaminated product from the market before illness occurs. The RFR requires that a company submit a report when there is a transfer of an FDA regulated food product outside the company and there is reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. In the first year of the registry, 2,240 reports were received. Of those, 229 were primary industry or regulatory reports, 139 were amended reports and 1,872 were secondary upstream or downstream reports. Interestingly, one event was a major contributor to the overall number of reports submitted. The initial report of Salmonella in hydrolyzed vegetable protein led to 1,001 reports across 11 commodity categories by upstream and downstream facilities. In the end, 177 products were removed from commerce and no illnesses were reported. In addition to recalls, RFR entries triggered two import alerts, six import bulletins, and four field assignments.

As depicted in the Figure, the number of Class I food product recalls, a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death, increased dramatically in both 2009 and 2010 compared to previous years. In 2008, there were 351 Class I recalls, compared with 1,779 in 2009 and 1,499 in 2010. The increase is largely due to a small number of recalls that had a wide-reaching impact, including the 2009 recalls of peanut products and pistachios due to potential contamination with Salmonella and the 2010 recalls of hydrolyzed vegetable protein and shell eggs due to potential contamination with Salmonella.Contamination of shell eggs with Salmonella enteritidis resulted in 1,939 reported illnesses between May and November of 2010, impacted 94 different products and resulted in over 500,000,000 eggs being recalled.
The emergence of expansive product recalls has impacted the trends surrounding the reason for the majority of Class I recalls. In 2008, 144 recalls, or 41 percent of Class I recalls were due to the presence of undeclared allergens and 135 recalls, or 38 percent of recalls were due to Salmonella. In 2010, 1,013 recalls or 90 percent of the Class I recalls were due to potential contamination with Salmonella and 201 recalls, or 17 percent of total class I recalls were due to undeclared allergens. While the number of recalls due to allergens has not changed significantly over the past three years, allergens have gone from being responsible for over 40 percent of all recalls to fewer than 20 percent of all recalls as a result of the massive increase in recalls due to Salmonella.
2010 saw a significant increase in the number of class II recalls. Class II recalls are defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” Interestingly, some products contaminated with Salmonella are classified as class II recalls according to the FDA weekly enforcement reports. For example, the October 20, 2010 Enforcement Report contains a class II recall of “pecan delights” and “milk chocolate pecan perk” products due to finished product testing positive for Salmonella. Some products implicated in the hydrolyzed vegetable protein recall were classified as class II while others were classified as class I. FDA’s criteria for classifying some Salmonella contaminations as a class II recall is not readily available and at first glance classifying Salmonella contaminated chocolate as class II appears to be an unusual decision. The rationale behind this is not obvious but it raises the question of whether this is a shift in FDA’s view of Salmonella contaminated products.
These massive recalls demonstrate the significant impact one contaminated ingredient can have on the entire food supply chain. Both the new reporting requirements under the RFR and new requirements for preventive controls under the new legislation will likely have a significant impact on what recall trends look like in upcoming years. There is an expectation in some that the new food safety legislation (the Food Safety Modernization Act) will reduce recalls. In reality it is probable that while 2009 and 2010 may be exceptions we will not see a reduction in recalls any time soon. Greater capacity to link foods with illness and the RFR will ensure that recalls will continue to stay at a high level, hopefully on a voluntary basis and not as part of the new mandatory recall authority.
Industry needs to review their ability to track ingredients to finished product to the consumer and trace back from product to ingredients. Beyond understanding the one-up, one-back requirements, there is an increased emphasis, both from FSIS and FDA on understanding one’s supply chain and ensuring that incoming product and ingredients are safe.
A critical message to the food industry is that as the supply chain increases in complexity and legislation places additional accountability on industry, it becomes increasingly more important for companies to manage their risk by knowing their suppliers. This strategy will help reduce the impacts of a recall and will allow firms to limit the extent of recalls to the greatest degree possible.
Author Credit Line: by David Acheson, Managing Director, Food and Import Safety Practice, at Leavitt Partners.  Leavitt Partners advises clients that invest in health care and food safety. Through partnerships and global connections, Leavitt Partners is able to address your food safety and food defense problems wherever they may be in

Source: globalfoodsafetyresource.com