OK, I admit it – Did I miss if the FDA deemed Peanut Butter a “High-Risk” food yet?

Following the tragedy of the PCA Salmonella peanut outbreak in 2008-2009, that sickened over 700 and killed nine, Dr. Stephen Sundlof of the Food and Drug Administration told lawmakers that agency inspectors will start to routinely collect samples for bacterial testing whenever they go into a peanut butter manufacturing facility.

“We are changing that now as a result of this (outbreak),” Sundlof, head of the FDA’s food safety center, told the House Energy and Commerce investigations subcommittee. The panel is looking for ways to prevent another outbreak like the one that has sickened some 600 people and is being linked to nine deaths. More than 1,900 products have been recalled.

Peanut butter may also be singled out for special attention. Sundlof said the government is weighing whether to designate it as a high-risk food. That means producers would be required to follow written food safety plans to prevent contamination.

Also in 2009, the US Food and Drug Administration (FDA) issued two sets of recommendations for reducing the risk of Salmonella contamination in peanut products, one aimed at the food industry and the other at food service establishments and retail stores.

The FDA’s action follows a 2-month investigation of a nationwide Salmonella Typhimurium outbreak linked to peanut butter, peanut paste, and other items made by Peanut Corporation of America (PCA) that has sickened 683 people in 46 states and has led to the recall of more than 2,833 products. The FDA published the documents on its Web site.

In its guidance for the food industry, the FDA said the document isn’t a set of guidelines, but rather its current thinking on addressing the risk of Salmonella contamination in foods that contain peanut products. It pointed out that Salmonella can become heat resistant as the water activity of a food becomes lower, conditions found in peanut butter and peanut paste.

The effectiveness of processing methods to reduce Salmonella in food products may depend on if and how much an ingredient with low water activity is rehydrated. Processing methods are more effective at killing the pathogen when the peanut ingredient is completely mixed into a high–water activity food, given time to fully rehydrate, and heated or acidified adequately. However, the pathogen may remain when lumps or swirls of peanut butter remain in the food product.

The FDA recommends that food manufacturers obtain peanut products only from suppliers that have validated procedures to reduce Salmonella contamination.

In instances when manufacturers must use raw shelled or blanched peanuts or when Salmonella concerns have been raised about a particular lot or lots of peanut ingredients, the FDA recommends that manufacturers:

• Ensure that their own manufacturing processes adequately reduce Salmonella contamination
• Adjust processing conditions to account for the food’s specific characteristics
• Keep in mind that the most reliable way to gauge if a manufacturing process reduces Salmonella in a peanut-containing food is to conduct microbiological challenge studies
• Avoid depending on negative tests by themselves in finished products to measure the efficacy of processes that reduce Salmonella

Following the passage of the Food Safety Modernization Act (FSMA) in 2011, the FSMA requires FDA to designate high-risk foods for which the proposed additional recordkeeping requirements “are appropriate and necessary to protect the known safety risks of a particular food, including the history and severity of the public health.” The high-risk food designation must be based on the following factors:

• Foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention (CDC)
• The likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce the food
• The point in the manufacturing process of the food where contamination is most likely to occur
• The likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination
• The likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food
• The likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

Did that ever happen?

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.