FDA presents position on Salmonella Heidelberg in layer houses

John Sheehan, director, division of plant and dairy safety, U.S. Food and Drug Administration, presented the agency’s position regarding Salmonella Heidelberg on egg farms at the Future of the American Egg Industry Conference, which was held in conjunction with the 2013 International Production & Processing Expo in Atlanta.

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trans961. Image from BigStockPhoto.com | The FDA says that egg producers must take action to prevent the sale of adulterated eggs if house environmental samples are found to contain either Salmonella Heidelberg or Salmonella typhimurium.
trans961. Image from BigStockPhoto.com | The FDA says that egg producers must take action to prevent the sale of adulterated eggs if house environmental samples are found to contain either Salmonella Heidelberg or Salmonella typhimurium.

John Sheehan, director, division of plant and dairy safety, U.S. Food and Drug Administration, presented the agency’s position regarding Salmonella Heidelberg on egg farms at the Future of the American Egg Industry Conference, which was held in conjunction with the 2013 International Production & Processing Expo in Atlanta. Sheehan, who communicated via telephone, said, “The agency's position is really rather straight forward. Salmonella Heidelberg is a human pathogen as are all Salmonellae. It is not a new issue.” He went on to explain, “The Healthy People 2000 progress report mentioned Salmonella Heidelberg as a major challenge.”

Egg producers did not see the FDA’s position regarding Salmonella Heidelberg as being clear or straight forward, and this uncertainty prompted a December 3, 2012, letter from the United Egg Producers to the agency. The letter, and the questions it raised, ultimately led to an invitation for agency personnel to address egg producers at the conference in January.

Egg Safety Rule

Sheehan said, “The Egg Safety Rule is about Salmonella enteritidis. Our goal, and the goal of the rule, is to essentially eliminate Salmonella enteritidis as a cause of foodborne illness as far as eggs are concerned. The focus of the agency is on Salmonella enteritidis, and we are looking for Salmonella enteritidis when we do investigations on farms; we are not looking for Salmonella Heidelberg. However, if we do learn about Salmonella Heidelberg being present on a premise, either in the production environment or on the eggs themselves, we as agency cannot safely ignore that fact; we have to do something about it.

“Now if Salmonella Heidelberg is found in the environment, we consider that to be a 402 A4 situation, which refers to a section of the Food, Drug and Cosmetic Act indicating that foods that are prepared, packed or held in conditions whereby they may be rendered injurious to health are considered to be adulterated,” Sheehan continued. “If you have Salmonella Heidelberg in your environment, we would consider that you have an A4 situation in your environment. If you have Salmonella Heidelberg in your eggs, then you have an A1 situation.” Sheehan said that an “A1” situation is when a pathogen or other harmful or deleterious substance is present in the food.

Transovarian transfer

“Our position with Salmonella Heidelberg is the same as Salmonella typhimurium. The reason is that both of these have shown the potential for transovarian transfer to eggs,” said Sheehan. “If you are doing your own environmental monitoring and find Salmonella Heidelberg or Salmonella typhimurium, then this creates an A4 situation. The expectation is that you would act immediately to remedy the situation. You have an affirmative duty to act once you have information.” 

It was not stated by Sheehan, who is an attorney, how the egg producer would be expected to act, but it seems apparent that if either Salmonella Heidelberg or Salmonella typhimurium is found in an environmental sample, the producer would be expected to hold and test eggs or divert them to the breaker until the eggs are found to be negative. It would also seem that the producer would be expected to take the same steps outlined in their Egg Safety plan that they would if Salmonella enteritidis was found in an environmental sample.

Indisputable facts

Dr. Gerardo A. Ramirez, Center for Food Safety & Applied Nutrition, Office of Food Safety, FDA, said, “There are three indisputable facts. First, Salmonella Heidelberg is capable of vertical transmission, albeit not to the level of Salmonella enteritidis, but it is capable. Second, Salmonella Heidelberg is a human pathogen; it is well documented that it can lead to illness and even death. The third fact is that eggs are a risk factor for Salmonella Heidelberg. I would say the same thing for any Salmonella.”

“If we have an organism that we know can be transmitted vertically, know can make people sick and sometimes kills people, and we know that eggs can be a source of that, then we can’t ignore that, and we won’t ignore that.”

Ramirez said that the FDA will look for Salmonella Heidelberg or Salmonella typhimurium in a trace-back investigation, and the agency will look for it if they have prior knowledge of Salmonella Heidelberg or Salmonella typhimurium on that farm. He cited the inspection of an egg farm that was previously linked to an egg recall on which Salmonella Heidelberg had been found in the trace-back investigation as an example of when the agency would look for Salmonella Heidelberg in environmental samples taken in future inspections.

Moving forward

Sheehan said that he has been asked a number of times if the FDA had plans to amend the Salmonella enteritidis rule to include other Salmonella serotypes. He said, “Is the FDA going to amend the Salmonella enteritidis rule? The short answer is no. We aren’t considering this at all.”

If an egg producer tests environmental samples for the presence of Salmonella serotypes in addition to the required test for Salmonella enteritidis, the agency says this producer has a responsibility to act if a sample is positive. Based on this, an egg producer in the audience asked if the agency was telling egg producers not to test for Salmonella Heidelberg.

“We are not telling you not to look for it [Salmonella Heidelberg],” said Sheehan. “You have to do everything that is prudent to not introduce adulterated food into commerce. You may reach the conclusion that you need to look for Salmonella Heidelberg and Salmonella typhimurium, or you may not. We will be looking for Salmonella Heidelberg and Salmonella typhimurium if there is an outbreak investigation.”

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