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.