September 13, 2011, will go down in the history of food safety as a very significant day.


It will be remembered by many as the day that Secretary Tom Vilsack of the U.S. Department of Agriculture (USDA) announced that the USDA and its Food Safety and Inspection Service (FSIS)  moved forward with the rule-making process to get the Big Six non-O157 Shiga toxin-producing E. coli (STECs) declared as adulterants in ground beef.

The proposed rule was sent to the Office of Management and Budget in January and has now evidently received OMB’s blessing.


The USDA announced Tuesday that the proposed rule will be posted in the Federal Register and public comments will be received for 60 days. It is the USDA’s goal to have the rule in effect and begin testing in March, 2012.


The Big Six is a phrase commonly used to indicate six sub-types of E. coli that cause over 80% of human foodborne illnesses attributed to non-O157 STECs each year in the U.S. The Big Six include O26, O111, O121, O103, O145 and O45. They do not include the deadly O104 strain that caused the recent outbreak in Europe.

There will be some who will say this is not enough, that O104 and all non-O157 STECs that can cause human illness should be considered adulterants, rather than naming each individual strain and then having to expand the list to include more strains in the future.

I would disagree at this time. The testing is just not there yet for every single strain of E. coli, and industry needs to be able to test before it can reasonably be held responsible for producing the safest product possible.

There will be some who will say that the rule-making process should have been avoided, and that the Undersecretary for Food Safety at the USDA, Dr. Elisabeth Hagen, has the legal authority to simply declare these pathogens adulterants and dispense with the long rule-making process.

Again, I would disagree. When Mike Taylor declared E. coli O157:H7 to be an adulterant in ground beef in 1994, he was responding to the Jack in the Box outbreak that sickened hundreds and killed four. He had the sense of a crisis on his hands.

In his book, “Creating Change”, John Kotter says the first thing you need to have to create change is a sense of crisis. Taylor had that, Dr. Hagen does not.

To learn the detailed history of this event that occurred in 1993, and to better understand the events that followed, one can read Jeff Benedict’s book, “Poisoned.”


The recent European outbreak served notice that these pathogens are not only equal at times in pathogenicity, some of them are even more deadly than the feared O157. But the offending food in the Germany-centered outbreak was sprouts, not beef, and it was an ocean away from us.

While the often-heard argument that these strains are not as potent as O157 waned after the Europe experience, there was no sense of crisis yet in the States.


Another outbreak an ocean away also occurred this year when E. coli O111 sickened over 100 and killed 4 in Japan. And this was from beef, but it was raw beef. But no crisis if we would all “just cook it.”


These two outbreaks, while increasing awareness about these pathogens and their deadly potential, did not create a sense of crisis in this country. We are not seeing Americans become ill in large numbers from eating beef that contains the non-O157 STECs, and therefore the open and transparent rule-making process is entirely appropriate.


There is a bit of history surrounding the non-O157 STECs that perhaps bears repeating one last time as FSIS moves forward, creating history. The decision to take the next step we heard about today was not made overnight. It was made after much thought and deliberation and increasing knowledge about the prevalence and lethality of the Big Six.

While I was serving as the Undersecretary for Food Safety at the USDA, a good friend advised me in 2007 that his laboratory was seeing at least an equal number of non-O157 STECs as O157 when testing stool specimens for possible foodborne illnesses.

That laboratory was the Public Health Lab in NE, and the good friend was Steve Hinrichs, MD, the director of the lab at the time.


A little research revealed most labs were not testing for non-O157s back then, but those that were had similar findings.

About the same time, an FSIS employee, working in the Office of Public Health and Science at the USDA, informed me that non-O157 STECs were an emerging infectious disease not generally recognized or appreciated by those with the power to create change.

That employee was Elisabeth Hagen, MD, an infectious disease expert and now the current Undersecretary for Food Safety at the USDA. Standing beside Secretary Vilsack as he made the announcement, Dr. Hagen should be recognized, for I know this positive development came from her efforts and may well be her food safety legacy.

With this new information on hand back in 2007, I asked Dr. Hagen to put together a conference on the public health significance of non-O157 STECs. That conference was held on the campus of George Mason University on Oct. 17, 2007.

We heard presentations on the epidemiology and human health burden of these pathogens, and we heard the latest on research in the U.S. and from Europe. Industry and consumer advocacy groups delivered other presentations.

The take-home message in 2007 was pretty simple. We did not have adequate testing available for ground beef, few labs were testing human specimens so we did not have an accurate assessment of the frequency of foodborne illnesses from non-O157 STECs, and we did not know the prevalence of the pathogens in ground beef.

FSIS and the Agriculture Research Service (ARS) at the USDA started the wheels in motion to correct these deficiencies and today they cannot be used as an excuse to do nothing to further protect our food supply.

Since October 2007, we have also seen petitions filed to declare the Big Six as adulterants and law suits threatened. In addition to the two previously mentioned outbreaks in Japan and Europe, we have also identified an increasing number of outbreaks and illnesses in the U.S.


Private citizens have funded ground beef testing, research universities have performed their own testing of beef, and the Meat Animal Research Center of the USDA, located in Clay Center, NE, has also contributed to the growing knowledge of non-O157 STEC prevalence.

ARS has produced the necessary testing protocols to allow Dr. Hagen to move forward. The testing will only improve during the rule-making process.

And the Centers for Disease Control adjusted their estimates for non-O157 STEC foodborne illnesses in the January, 2011, edition of Emerging Infectious Diseases. That number now stands at 113,000 cases per year, making these pathogens the sixth leading cause of foodborne illnesses in the U.S. and double that credited to E coli O157:H7.

Some in industry have been preparing for this day, and Costco and BPI are already testing their products for non-O157s. Others will now follow.

And still some opponents have already said the probable added cost of beef is a reason to not endorse this action.

The USDA has estimated the industry cost to be around $10 million. There are 300 million of us in this country, most of whom eat beef on a regular basis. My mathematics puts this extra cost at about 3 cents per American per year.

For 3 cents, I will supp
ort the USDA’s efforts to
protect myself and my grandchildren. Heck, I will even pay the extra cost for those kids myself.


Phages are being developed that will help packers keep the pathogens out of their plants, and vaccines and probiotics will surely follow.


Perhaps now that the consumer advocates have seen their non-O157 STEC dream fulfilled, they will adjust their stance on whole carcass, low-dose irradiation. Talk about a win-win.

We need to give industry this vital and critical processing aid to make our meat even safer than it already is. And, yes, to protect their bottom line.

Meat is considered adulterated “if it bears or contains any poisonous or deleterious substance which may render it injurious to health.” It is amazing to me that this will be only the second time a bacteria has been labeled an adulterant in the meat we eat.

Dr. Hagen has repeatedly said that she wants more in the way of prevention, as opposed to reaction. This step would have been much easier if she had waited until we had an outbreak that matched Europe’s or Japan’s, creating a sense of crisis.


But she did not.  She moved toward prevention. She will save lives, maybe mine or my grandchildren’s. But she will never know. That is public health, and she is a Public Health Champion in my book.


Great job USDA, FSIS and Dr. Hagen. May your compasses stay true to the cause as you weather some stormy seas ahead.

Richard A. Raymond, MD, was USDA Undersecretary for Food Safety, 2005-2008.