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Salmonella outbreaks: Why was the FDA in the dark?

February 5, 2009

MinnPost
By Cynthia Dizikes
Thursday, Feb. 5, 2009

http://www.minnpost.com/stories/2009/02/05/6486/salmonella_outbreaks_why_was_the_fda_in_the_dark

WASHINGTON, D.C. -- So why, exactly, didn’t the FDA learn about repeat salmonella outbreaks at the now-infamous Georgia peanut-processing plant sooner?

It’s a question Sen. Amy Klobuchar (D-Minn.) wanted answered during a Senate committee hearing today because it arguably cost three Minnesotans their lives recently after they ingested contaminated peanut products from the plant.

“One victim was Shirley Mae Almer of Perham, a town in northern Minnesota. At the age of 72 she was still a strong lady but on December 21 she died and she died because every morning she liked to have toast with peanut butter,” Klobuchar told the food safety officials, who were asked to testify at the hearing. “I believe it’s shameful that a death like this could happen in America.”

Klobuchar then had this exchange with Dr. Stephen Sundlof, the director of the center for food safety and applied nutrition at the Food and Drug Administration:

Klobuchar: “Dr. Sundlof, I listened with some interest and a sort of shock that we now, it seems to me... that a company can repeatedly have a salmonella problem in their plant and the FDA never knows about it. [Raised eyebrows.] Is that correct?”

Sundlof: “Yes, that’s correct. Again, the law that has recently passed the Food and Drug Administration amendments act does give us some additional authority to require that information if they have already shipped the product from their facility.”

Klobuchar: “So you have to have the shipping, which obviously creates a much more hazardous possibility, before you can even find out. Do you think this is something the FDA should know about when you have repeated outbreaks of salmonella at a plant?”

Sundlof: “We would like to have as much information as we possibly can get. Yes.”

Klobuchar: “But right now you don’t have that information and if the states have it, if the states find out about it...then you automatically get it?”

Sundlof: “If they report it to us. The states do a lot of inspections on their own. We don’t necessarily have access to that.”

Klobuchar: “So they are not automatically required to give you the information.”

Sundlof: “They are not.”

Klobuchar: “So we have a situation where plants can have repeated salmonella discoveries, they’re not required to tell you, and then you have state departments in food and drug inspection that find this out and they’re not required to tell you?”

Pregnant pause (as they call it).

Klobuchar: “Is that correct?”

Sundlof: “I think so.”

Klobuchar: “Yet we have seen from these deaths across the country that this isn’t a single state issue. To me, it seems like it is a national issue.”

Sundlof: “That’s correct.”

Klobuchar: “All right.”

As Klobuchar implied in her line of questioning, it’s potentially a big problem that the FDA has limited access to the information coming out of inspections that are done on a state level, especially since many companies distribute their products across state lines.

In this case, it likely cost people their lives. As Sundlof testified, the company had received positive test results for traces of salmonella on at least 12 previous occasions. But, under current law, the plant was not required to report those results to the FDA.

Another hearing on the issue is scheduled for Wednesday.