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“FDA does consider any disease-causing strain of E. coli in food to be illegal”

A few days ago I posted – “The FDA and Revisionist History of its Position on non-O157 E. coli” about what seemed to be some juggling of words and sentences in a series of FDA Press Releases about the E. coli O104:H4 outbreak in Germany. This morning I got a response from the FDA clarifying that in fact the “FDA does consider any disease-causing strain of E. coli in food to be illegal.”  Here is the email chain (FDA in italics):

From: “DeLancey, Siobhan” <Siobhan.Delancey@fda.hhs.gov>

Date: Thu, 7 Jul 2011 11:34:45 -0400

To: Bill Marler <bmarler@marlerclark.com>

Subject: FDA statement on E. coli

Hi Bill,

A consumer notified me of your blog post on our press release on the E. coli O104 outbreak in Europe. As is often the case in these situations, there’s a simple and not very mysterious explanation.

Back on June 3, FDA posted an early [not finalized] draft of a press release titled “FDA statement on E. coli O104 outbreak in Europe.” Less than an hour later, we posted the final release, which was the same one that went to reporters via our distribution list.

As we have been stating since the outbreak in Europe, FDA does consider any disease-causing strain of E. coli in food to be illegal.

Hope that helps to clarify.

Siobhan DeLancey, RVT, MPH

Team Leader for Food, Veterinary and Cosmetic Products

FDA Office of Public Affairs

Office: 301-796-4668

BB: 202-510-4177

FDA Press Beat List:

http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default.htm

__________________

From: Bill Marler [mailto:bmarler@marlerclark.com]

Sent: Thursday, July 07, 2011 12:03 PM

To: DeLancey, Siobhan

Subject: Re: FDA statement on E. coli

You know I am a big supporter of the FDA’s mission (see, http://www.bloomberg.com/news/2011-07-06/fda-seeks-1-4-billion-for-food-safety-law-as-budget-faces-cuts.html) and worked my tail off on the FSMA, so I do not take to criticizing friends lightly. So, what you are saying is that the first version of the paragraph was a draft and was up for less than an 1 hour?

The original paragraph read (my emphasis):

“Food growers, manufacturers and distributors are responsible for marketing safe food and taking any steps necessary to ensure that their products are indeed safe,” said Donald Kraemer, deputy director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA considers any disease-causing strain of E. coli in food to be illegal. The FDA has provided scientific guidance to the produce industry on ways to minimize the risk of E. coli, and these methods will reduce the risk of the strain of E. coli causing the European outbreak as well as the more common strains.”

And, then was replaced with this new paragraph reads:

“Food growers, manufacturers and distributors are responsible for marketing safe food and taking any steps necessary to ensure that their products are indeed safe,” said Donald Kraemer, deputy director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA has provided scientific guidance to the produce industry on ways to minimize the risk of E. coli, and these methods will reduce the risk of the strain of E. coli causing the European outbreak as well as the more common strains.”

The only change being “The FDA considers any disease-causing strain of E. coli in food to be illegal.”

Yet you now say in your email to me “FDA does consider any disease-causing strain of E. coli in food to be illegal.”

No, that does not clarify things.

William D. Marler, Esq.

Marler Clark

The Food Safety Law Firm

1301 Second Avenue, Suite 2800

Seattle, WA 98101-3808

Direct Line: (206) 346-1890

Cell: (206) 794-5043

Main Line: (206) 346-1888

Toll Free: (800) 884-9840, ext. 1890

Main Facsimile: (206) 346-1898

Email: bmarler@marlerclark.com

Blog: www.marlerblog.com

Twitter: @bmarler

Facebook: MarlerClarkBlog

Website: www.marlerclark.com

____________________

From: “DeLancey, Siobhan” <Siobhan.Delancey@fda.hhs.gov>

Date: Thu, 7 Jul 2011 12:49:22 -0400

To: Bill Marler <bmarler@marlerclark.com>

Subject: RE: FDA statement on E. coli

That’s correct–the first version was up for less than an hour. As I said, it was an earlier draft that was posted inadvertently at 5:05 pm and then the final version (the same one issued to reporters) was posted at 6:01, back on June 3. I double-checked the time stamp on the web posting to be absolutely sure.

This was not the only change to the release–there were other edits as well, which is not unusual. Our releases go through several different versions before being finalized. Our stance, however, remains the same–pathogenic forms of E. coli in food are an adulteration if they are injurious to health, ergo “illegal.”

I do appreciate your support of our mission, and I’m sorry that this caused such consternation. In retrospect, we should have put up a note explaining that an earlier draft had been posted and was subsequently replaced with the final version. I’ll talk to my superiors about making that part of the SOP for the future.

Siobhan DeLancey, RVT, MPH

Team Leader for Food, Veterinary and Cosmetic Products

FDA Office of Public Affairs

Office: 301-796-4668

BB: 202-510-4177

FDA Press Beat List:

http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default.htm

__________________

From: Bill Marler [mailto:bmarler@marlerclark.com]

Sent: Thursday, July 07, 2011 12:55 PM

To: DeLancey, Siobhan

Subject: Re: FDA statement on E. coli

Since I have gotten swamped with calls and emails about it, can I post this explanation which makes perfect sense.

William D. Marler, Esq.

Marler Clark

The Food Safety Law Firm

1301 Second Avenue, Suite 2800

Seattle, WA 98101-3808

Direct Line: (206) 346-1890

Cell: (206) 794-5043

Main Line: (206) 346-1888

Toll Free: (800) 884-9840, ext. 1890

Main Facsimile: (206) 346-1898

Email: bmarler@marlerclark.com

Blog: www.marlerblog.com

Twitter: @bmarler

Facebook: MarlerClarkBlog

Website: www.marlerclark.com

___________________

From: “DeLancey, Siobhan” <Siobhan.Delancey@fda.hhs.gov>

Date: Thu, 7 Jul 2011 12:56:25 -0400

To: Bill Marler <bmarler@marlerclark.com>

Subject: RE: FDA statement on E. coli

Absolutely. I’ve already talked to a couple reporters as well.

Siobhan DeLancey, RVT, MPH

Team Leader for Food, Veterinary and Cosmetic Products

FDA Office of Public Affairs

Office: 301-796-4668

BB: 202-510-4177

FDA Press Beat List:

http://www.fda.gov/NewsEvents/Newsroom/MediaContacts/default.htm

___________________

I am sure glad this is cleared up.

  • Bix

    That was a courteous response!
    This was nice…
    “Our stance, however, remains the same–pathogenic forms of E. coli in food are an adulteration if they are injurious to health, ergo “illegal.” ”
    But you’re back to your original question regarding FSIS:
    “The FDA takes the position that it “considers any disease-causing strain of E. coli in food to be illegal.” FSIS does not. Why?”

  • Minkpuppy

    Bix–FSIS is under the thumb of the big 3 packers, that’s why they don’t consider any disease causing strain of E. coli illegal. God forbid FSIS or USDA should stand up to them. They effectively control an overwhelming majority of meat processing in this country, yet are somehow not considered a monopoly. How does that work?
    Lawsuits like the Supreme Beef fiasco made sure the Agency’s hands were effectively tied when it comes to enforcing performance standards and naming anything other than O157 as adulterants. When there’s no support from the White House or Congress, then chances are it’s not going to happen anytime soon.