November 2010

That is not meant as a slam against the Democrats now or when the Republicans took us in year’s past from a surplus to tax breaks for the weathly, medicare drug benefits and two wars.

Screen shot 2010-11-30 at 10.10.13 PM.pngI was having a relaxing evening for a change until I received an email from John Stanton of Roll Call noting that “[a] food safety bill that has burned up precious days of the Senate’s lame-duck session appears headed back to the chamber because Democrats violated a constitutional provision requiring that tax provisions originate in the House. Section 107 of the bill includes a set of fees that are classified as revenue raisers, which are technically taxes under the Constitution.” Section 107 states:

Directs the Secretary to assess and collect fees related to: (1) food facility reinspection; (2) food recalls; (3) the voluntary qualified importer program; and (4) importer reinspection.

Per Mr. Stanton, “[a]ccording to a House GOP leadership aide, that section has ruffled the feathers of Ways and Means Committee Democrats, who are expected to use the “blue slip process” to block completion of the bill.”

However, this possible squabble may well have an elegant, possible solution to funding for food safety legislation. As you might already know, in the House version of its food safety bill, H. R. 2749, lies Sec., 743. FACILITY REGISTRATION FEE.

(b) Fee Amounts-

(1) IN GENERAL- The registration fee under subsection (a) shall be–

(A) for fiscal year 2010, $500;

So, if the House is already charging $500 per year, per facility, why can not the House and Senate in conference agree that the $500 fee, (that S. 510 did not have in the first place) would replace S. 510 Sec. 107?

It is late and I simply do not know the answer.  And, I have not even talked about issues that the House may well have over the Tester/Hagen Amendment which at this point the House needs to leave alone.

I got up really early to watch the vote of CSpan and still can not quite beleive it passed and with a margin of 73 in favor and 25 against.  The Bill that in large part will do:

  • food-safety-rating-system.jpgAllow the FDA to order a recall of tainted foods;
  • Require larger food processors and manufacturers to register with the Food and Drug Administration and create detailed food safety plans (Tester/Hagen Amendment excluded most small farmers from FDA regulatory oversight) ;
  • Require the FDA to create new produce safety regulations for producers of the highest-risk fruits and vegetables;
  • Require CDC and State Health Departments to coordinate Foodborne Illness surveillance;
  • Establish stricter standards for the safety of imported food;
  • Increase inspections of domestic and foreign food facilities, directing the most resources to those operations with the highest risk profiles.

From a pro legislation perspective, I am pleased that it has passed the Senate, but I wonder how it will be able to get through the House and to the President’s desk before years end. I am most heartened that passage was one of the most bi-partisan votes we have seen in a very long time. It is good to see R’s and D’s coming together to actually try and doing something good for the American people. Perhaps this means we can work together to solve the budget deficit, two wars, unemployment – Sorry, I got caught up in the moment. I’ll leave the comments on the cons to this email I got this morning:

This Bill is a disgusting breech of democracy. It does the opposite of what it claims. It’s nearly impossible to get natural healthy food in the market. I hate this. It’s evil. I want to eat unprocessed food. food that actually tastes goodand is chemical and cruelty free. This is fascist. I don’t tell you what to eat! Get out of this kind of bullying. You only serve corperate interest not the people.

We clearly have more work to do.

I know it is a bit odd for a foodborne illness trial lawyer to act as publisher (think of me as a good Rupert Murdoch) of an online newspaper, but I a very proud of what the staff, interns, freelancers and contributing writers have accomplished over the last year, and look forward to FSN’s continued opperation. Having people in D.C., Denver and Seattle has allowed FSN quick access to several of the major foodborne illness outbreaks in the last year (FSN was on the ground during the Gulf Oil Spill, the Wright County Egg Recall, etc.), as well as second by second coverage (via twitter) of what is, or is not happening in DC.  Here is some of the story of FSN:

Food Safety News encourages contributed articles and Op-eds.  Take the time to let your voice be heard.  Also, thanks the subscribers and readers.  Although small by New York Times standards, FSN is catching up.

Screen shot 2010-11-30 at 11.27.56 AM.pngFor those that recall back to August 2010, Cargill Meat Solutions Corp., recalled approximately 8,500 pounds of ground beef products that may be contaminated with E. coli O26. The product subject to recall included: 42-pound cases of “GROUND BEEF FINE 90/10,” containing three (3) – approximately 14 pound chubs each. These products have a “use/freeze by” date of “07/01/10,” and an identifying product code of “W69032.”  FSIS became aware of the problem on August 5, 2010 when the agency was notified by the Maine Department of Agriculture, Food and Rural Resources of an E. coli O26 cluster of illnesses. In conjunction with the Maine Department of Health and Human Services, Maine Department of Agriculture, Food and Rural Resources, the New York State Department of Health, and New York State Department of Agriculture & Markets, two (2) case-patients have been identified in Maine, as well as one (1) case-patient in New York with a rare, indistinguishable PFGE pattern as determined by PFGE subtyping in PulseNet.

Now, FSIS has issued Notice 70-10 today. Is says in pertinent part:

In the event of a sample positive for either E. coli O157:H7 or E. coli O26, FSIS would request a recall for product that entered commerce.

As those who follow my blog (and can stand the too frequent updates) know, the CDC estimates that “non-O157 STECs (like O26, O45, 0103, O111, O121, and O145) cause 36,700 illnesses, 1,100 hospitalizations and 30 deaths in America each year.”

We have Petitioned FSIS to list the above six STECs as adulterants, it is good to see that FSIS has moved forward on one – five to go.  I also sent a letter to FSIS today:

In light of FSIS Notice 70-10 issued on today’s date, I respectfully request that FSIS issue an interpretive ruling declaring enterohemorrhagic Shiga Toxin-producing Serotypes Escherichia coli O45, O103, O111, O121, and O145 (in addition to O26), to be Adulterants within the meaning of 21 U.S.C. § 601(m)(1).


“This is like déjà vu all over again” by Yogi Berra is what I was thinking as a read the below article from the REVUE CANADIENNE DE SANTÉ PUBLIQUE as I was researching the FDA’s “60 day rule.”

An Outbreak of E. coli O157:H7 Hemorrhagic Colitis Associated with Unpasteurized Gouda Cheese

Yogi Berra.jpgLance Honish, BSc, Gerry Predy, MD, Nyall Hislop, BSc, Linda Chui, MSc, Kinga Kowalewska-Grochowska, MD, Larry Trottier, BSc, Cornelia Kreplin, DVM, Ingrid Zazulak, CPHI(C)

Background: A cluster of E. coli O157:H7 hemorrhagic colitis was identified in metro Edmonton, Alberta through notifiable disease surveillance in late 2002.

Methods: Environmental health officers collected food histories and clinical information from cases in the cluster. The provincial public health laboratory conducted pulsed field gel electrophoresis (PFGE) analysis on E. coli O157:H7 isolates from cluster cases. Public health and food regulatory agencies conducted an investigation when a food source (unpasteurized gouda cheese) was implicated.

Screen shot 2010-11-28 at 4.55.41 PM.pngResults: PFGE analysis revealed an “outbreak” profile in 13 cases. Onset dates for the outbreak cases ranged between October 2002 and February 2003. Two cases, aged 22 months and 4 years, developed hemolytic uremic syndrome as a result of their infection. Consumption of unpasteurized Gouda cheese produced at a local dairy farm was reported by 12 of 13 outbreak cases in the 2 to 8 days prior to illness. E. coli O157:H7 was isolated from 2 of 26 cheese samples manufactured by the implicated producer. The cheese isolates had indistinguishable PFGE profiles as compared with outbreak case isolates. Implicated cheese was found to be contaminated with E. coli O157:H7 104 days after production, despite having met regulated microbiological and aging requirements.

Conclusion: To our knowledge, this is the first confirmed outbreak of E. coli O157:H7 infection in Canada associated with raw milk hard cheese. A review of federal legislation vis-à-vis raw milk hard cheese may be in order.

It is going to make it a bit hard for Bravo to complain that the recent E. coli O157:H7 outbreak was something that could not be anticipated. And, in this 2002-2003 outbreak the Gouda had aged 104 days! Makes the FDA’s “60 day rule” seem more than a bit beside the point.

Boy do I know how to have fun; cleaning up the yard after a wind and snowstorm (that carried sub-freezing temperatures), and doing the bi-weekly chicken house cleaning (sorry, no eggs yet). Between those tasks, I have been reading up on the genesis of the 60-day aging of cheese (21 CFR 133 et seq.). I plan on doing a longer piece, yet I still find it odd that the “60 day rule” has been around so long (over ½ a century) without a lot of apparent recent thought to it.

raw-milk-cheeses-590.jpgIn a nutshell, the FDA generally requires that cheese be aged for a minimum of 60 days at a temperature of not less than 35°F made from pasteurized or raw milk. This requirement was put in place because it was believed that such an aging process acted to reduce the level of pathogens present in the cheese, thus making it safer for consumption.

However, apparently, several years ago, researchers at South Dakota State University published a study showing that 60-day aging was largely ineffectual in reducing levels of E. coli O157:H7 in certain cheese. Since then, research by Dr. Joseph Schlesser of the National Center for Food Science and Technology in Summit-Argo, Illinois, also has supported the finding that 60-day aging is largely ineffectual as a means of reducing levels of certain pathogens in cheeses.

So, FDA, why does it take several years, and the recent E. coli O157:H7 outbreak in Gouda cheese, to start a real dialogue on the “60-day rule?’

Screen shot 2010-11-26 at 6.29.21 PM.pngAccording to Derek Demo of KHSL TV 12 in Chico-Redding E. coli O157:H7 victim Olivia Henderson is out of the hospital, but not out of the woods.

“It’s just hard to put into words. You hear of people having E. coli, but you never think of it actually happening to a member of your family” said Sue Henderson. Unfortunately, that’s exactly what happened to Sue’s 10-year old granddaughter. Olivia Henderson was air lifted to U.C. Davis on October 1st after she was diagnosed with E. coli. After spending four weeks (likely with Hemolytic Uremic Syndrome – HUS) in the hospital, she is now home, but her fight is far from over. “All around it’s been very, very difficult” Henderson said.

The Corning Volunteer Fire Department is stepping in to lend a helping hand. The department has organized a spaghetti feed fundraiser for December 4th and is also collecting donations to help the family with growing hospital bills. Community members are also putting on an all you can eat tri-tip and crab feed which will be held December 11th.

And, what will the numbers be in 2011 when the CDC releases new estimates of foodborne disease?

In 1999 the CDC using FoodNet estimated that foodborne diseases caused approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year. These numbers are cited as frequently as we also hear the phrase: “We have the safest food supply in the world.”

In 1999 known pathogens accounted for an estimated 14 million illnesses, 60,000 hospitalizations, and 1,800 deaths. Three pathogens, Salmonella, Listeria, and Toxoplasma, were responsible for 1,500 deaths each year, more than 75% of those caused by known pathogens, while unknown agents accounted for the remaining 62 million illnesses, 265,000 hospitalizations, and 3,200 deaths.

Screen shot 2010-11-26 at 5.39.16 PM.png

The CDC qualified the above estimates by noting that the analysis suggested unknown agents account for approximately 81% of foodborne illnesses and hospitalizations and 64% of deaths. The CDC also noted several assumptions that were used to quantify the data. The first assumption concerned the degree of underreporting of bacterial and viral disease. The second assumption concerned the frequency of foodborne transmission for individual pathogens. And, the third assumption concerned the frequency of acute gastroenteritis in the general population.

In 2009 the CDC using FoodNet found a total of 17,468 laboratory-confirmed cases of infection were identified. In comparison with the first 3 years of surveillance (1996-1998), sustained declines in the reported incidence of infections caused by Campylobacter, Listeria, Salmonella, Shiga toxin-producing Escherichia coli (STEC) O157, Shigella, and Yersinia were observed. The incidence of Vibrio infection continued to increase. Compared with the preceding 3 years (2006–2008), significant decreases in the reported incidence of Shigella and STEC O157 infections were observed.

Screen shot 2010-11-26 at 5.15.51 PM.png

The coming 2011 estimates are expected to be more refined – primarily due to ten more years of FoodNet data. The numbers are also expected to be adjusted downward – possibly limiting, or eliminating norovirus – as norovirus accounted to a large percentage of the previous estimates. In addition, the continued decease in actual bacterial illnesses, as shown in the 2009 FoodNet data, should also show additional declining numbers.

It will be most interesting to see which groups claim victory over the numbers or how the data is explained – 2011 should be interesting.