On May 26, Food Safety News published an article written by law student Brianna Leach titled “The meat industry’s grip on government—time for an overhaul?”

If this essay by a law student is “the best to be selected for publication in FSN” then I feel sorry for those who have to plow through those that don’t meet the mark.

In the essay Ms. Leach not only attacks the protein industry, but the three branches of the federal government of which she must know little about.

Legislative
She bemoans the fact that the meat industry employs lobbyists to build relationships with Congress. She implies that they control the Chairs of the Ag Appropriations Committees so nothing gets by them that they don’t want.

She obviously has never met Congresswoman Rosa DeLauro, D-CT, who was chair of the House Ag Appropriations Committee while I was Undersecretary for Food Safety at the USDA. She took her marching orders from consumer groups like Food and Water Watch, Consumer Federation of America, CSPI and the Consumer Union, not to mention the union representing USDA’s food inspectors.

She single handedly shot down my proposed Risk Based Inspection System that would have put more inspector hours in plants with bad food safety records and plants making riskier foods.   

She seems to be in favor of plants paying for inspection, a plan riddled with problems.

First of all, if the inspector is being paid by the plant vs. the government, is it not likely that favors will follow? Like; “clean up that mess before I get back and you won’t get a citation.”

Secondly, she would likely shutter many small plants already hanging by a thread and just compound the problem of monoliths producing even a higher percentage of products. 

Executive branch: USDA’s puppet master
She says industry workers will “learn the trade of identifying diseased and contaminated meat.”

Excuse me Ms. Leach, but even the best trained FSIS inspector cannot identify Salmonella or E coli on meat.  What the plant workers are doing is sorting out blemishes and broken bones, quality concerns to protect the brand. 

Remember, Ms. Leach, these are basically young, healthy animals. Old cull cows, steers and bulls still get FSIS inspection on the lines.

She mentions that FSIS employees are required to be in the facilities and some have contracted COVID. She does not clarify if they contracted the virus in the community or in the plant, but here is where her true agenda begins to shed some light.

If the inspectors don’t go to work because of COVID, we can’t kill animals.

She further sheds light on her agenda when she says instead of focusing on keeping meat producing plants open, the president singles out meat “without regard for the many alternative sources of protein including dairy and produce. . . .”

When I had the authority, I took away the authority for JBS Swift’s beef plant in Greeley, CO, to ship to Japan. 

I also shut down Tyson’s “raised without antibiotics” label because it was just not true. That was after they spent millions promoting and developing it. 

Ms. Leach, I was nobody’s puppet, and I take personal offense in your implying that I, along with the entire USD, was. 

Animal rights groups have claimed COVID came about because of inhumane handling of animals and because of factory farms. They are using the pandemic to line their pockets.

Ms. Leach suggests the pandemic “originated from a processing facility in China. . . .”

Once more with the anti-meat, not so subtle, agenda.

That is truly news to me. I have heard maybe wet fish markets, bats and even a contaminated worker from the virology lab located there; but a processing plant? 

That is a pretty big stretch for a law student to suggest as the source when experts, loaded with data, still cannot 100 percent identify the true source.

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Dr. Elisabeth Hagen left the USDA in December of 2013, leaving the position of the USDA’s Undersecretary for Food Safety vacant and President Obama chose not to fill it for the remainder of his term.

Trump got Ted McKinney in as the USDA’s Undersecretary for Agriculture Trade and Foreign Affairs and my old friend from Nebraska, Greg Ibach, as the Undersecretary for Marketing and Regulatory Affairs almost immediately after he put his left hand on a bible and raised his right.

He finally got around to nominating Dr. Mindy Brashears last Spring, more than two years after taking over the Oval Office, as the next Undersecretary for Food Safety at the USDA, the highest ranking food safety official in the federal government.

I guess if the title contains words like “Trade” and “Marketing” our President thinks they are more important than titles that include “Food Safety”.

The Senate Ag Committee drug its heels on her hearing while drafting and debating the Farm Bill, and by the time Dr. Brashears got her Senate confirmation hearing followed by a bipartisan vote to advance her nomination to the full Senate body the clock was ticking on the 2018 version of the U.S. Senate.

Plus the Senate was now preoccupied with trying to find a way to keep the government running.

The wall was much more important than having the top food safety position filled.

In some fairness to the Republican leadership of the Senate, if he had advanced her nomination to vote of the body, by law the Democrats can debate the vote for up to thirty hours, basically shutting the Senate down. 

Heck of a way to run a government.

So we get to 2019 and President Trump has to re-nominate Dr. Brashears. There is some debate as to whether or not she will have to go through the stress of another Senate Ag hearing.

So, while not quite declaring a national emergency, as his Boss has threatened if he does not get his way, Secretary Perdue has named Dr. Brashears as the USDA’s Deputy Undersecretary for Food Safety, a position not needing Senate confirmation. But also a position not carrying the political clout and importance of the Senate confirmed the version of the Undersecretary.

She started Jan. 29, the day of the announcement. It seems she had moved the family and personal belongings to the D.C. area some time ago, leaving her paying job at Texas Tech and feeling the pain of no paycheck along with 800,000 federal employees.

I think the early move had something to do with her youngest daughter enrolling for the second semester of her senior year of high school, but what a nerve-wracking mess. And she has less than two years to get something positive done.

Heck of a way to run a government.

Asians especially place great importance on titles, and a Deputy Undersecretary will not get seated at the “big table.” Heck, she might not even get invited to visit unless she promises to buy their chicken meat. But the Vice Minister for Food Safety in China knows that as a Deputy Undersecretary she does not have the clout to back up that promise — it has been made too many times already.

The Australians and New Zealanders will simply smile and say to themselves, again; “We are so much better organized and more efficient than the United States.”

Much of Asia will say a dictatorship gets things accomplished but democracy gets stuck in the mud trying to see which way the wind is blowing to secure the next election.

The EU still won’t buy our chickens and beef until a person that can speak for the U.S. is in the chair of the Undersecretary.

And until she gets that confirmation, she will not have the political clout necessary to Chair the U.S. government’s Codex Alimentarius steering and advisory committee.

That committee consists of the Food Safety and Inspection System, the Trade and Foreign Affairs Office, and the Marketing and Regulatory Affairs Office of the USDA.

But it also includes representatives from the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA, and representatives from State, Commerce, Treasury and the U.S. Trade Office among others.

Big Time Players.

How is a Deputy that is not Senate confirmed expected to butt heads with the likes of McKinney and Ibach who have been in place for two years and have learned the ropes and who their friends and enemies are, much less some career folks from State and Commerce?

The Undersecretary for Food Safety also co-chairs, along with the Director of CFSAN, the National Advisory Committee on Microbiological Criteria for Foods (NACMCF). 

So there are at least two Chair positions that have not had an Undersecretary fulfilling those important obligations for over five years now.   

Secretary Perdue made a good move to get Dr. Brashears inside the Jamie Whitten Building and in her temporary office two doors down from the Undersecretary’s office, and also at the weekly briefings in “The Cage.” 

At least she can start learning the players, and who will be on her side, who will quietly work against her agenda, and who will simply say “she has less than two years, we can wait her out”.

I was advised 13 years ago that there are two sayings in D.C. that you need to remember, and I am sure someone has so advised Dr. Brashears.

1. When two or more people are having a conversation it is a public meeting and may be reported in the Washington Post
2. You have no trustworthy friends in D.C. except your dog, and don’t be too sure about him or her.

Heck of a way to run a government.

Editor’s note: This opinion column was originally posted be Feedstuffs and is posted here with permission.

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First of all, remember these opinions are mine and mine only. I am certain many would challenge or disagree with what I think was the biggest development to improve food safety.

And before I begin to elaborate on my thinking, I will tell you why I picked 25 years as the timeline, since 25 years ago I was directing a family practice residency program in Omaha, NE, and my 18 residents and two high school age children pretty much occupied all of my time. Food safety was relegated to my wife.

Editor’s note: This column was originally published by Feedstuffs and is reprinted here with permission.

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Yes, let us count the ways the federal government has failed to keep us safe from a foodborne illness.

First is the current, growing E. coli O157:H7 outbreak linked to precut romaine lettuce. As of April 19, 53 persons have been reported ill from this bug, involving 16 states, with 31 hospitalized.

That is a 60 percent hospitalization rate, almost twice the normal, so this bacterium is an especially virulent strain. Maybe it could be called a super bug?

And what have the Food and Drug Administration and Center for Disease Control and Prevention to assure our safety? They have advised throwing out any romaine lettuce grown in Arizona.

That is a pretty big safety net. Why not name the brand and the stores it was sold in?

Oh, right, proprietary, confidential corporate information (CCI). Protect the companies, not the public.

The U.S. Department of Agriculture started naming retail outlets for meat and poultry products contaminated with E. coli O157:H7 and other pathogens in 2008. Industry was not happy, but it was the right thing to do to protect the public’s health. Ten years later FDA still refuses to inform us if we are at risk or not.

FDA’s top leafy greens scientist says this is no problem, as the Arizona growing season is coming to an end and the shelf-life of precut lettuce is very short. He is even quoted as saying the leaves will start turning brown after one week of being precut, so most of it will be discarded very shortly.

Boy howdy, that makes me feel really good about that romaine lettuce in my crisper right now.

And on the same day, April 19, I get an email from the Government Accountability Office (GAO) announcing a new report criticizing USDA for not doing enough to keep our meat and poultry free from bacterial contamination. Included in the report is a picture of an open refrigerator door. It shows ground beef on a shelf directly above fresh red peppers and a turkey breast next to the peppers.

Whatever happened to the recommendation that raw meat and poultry are kept in a separate compartment, below all other items, to keep any juices containing Salmonella or E. coli from dripping on to fresh vegetables that were not meant to be cooked?

Talk about a misleading public information visual.

Among the GAO recommendations to USDA was that it should have established standards for Salmonella levels on pork chops.

Readers, please help me out here. I have only been involved in the food safety arena for 20 years, so will someone with a longer history please advise me of when the last foodborne illness outbreak linked to Salmonella and pork chops occurred?

I mean, seriously, this is not like ground beef, with products from multiple sources blended together, or poultry with Salmonella migrating inward into muscle following a feather’s follicle, or even a blade or needle tenderized steak.

This is an intact cut of meat, sterilized by simply cooking it.

Another recommendation was for the administrator of the Food Safety and Inspection Service (FSIS) to provide information about on-farm practices to reduce pathogen contamination by “controlling Salmonella in hogs.”

Seriously, I cannot make something like this up.

FSIS has no control over on-farm practices. Maybe APHIS does, but not FSIS.

And, FSIS has not had an appointed administrator since President Donald Trump was inaugurated.

Hey, GAO the number one source of Salmonella foodborne illnesses is green leafy vegetables, not hogs.

Why not write recommendations as to how FDA, in conjunction with the much ballyhooed Food Safety Modernization Act, could reduce the contamination rates for green leafy vegetables that are not meant to have cooking as a final kill step?

Maybe GAO could write a report for FDA, urging for a clarification of the sources and retail outlets of green leafy vegetables when they are linked to a very serious and growing outbreak and leave the pig farmers alone.

If we want to reduce salmonellosis as a foodborne illness, the government needs to use its resources to attack the number one source, green leafy vegetables, and not some meat product, pork chops, that are basically one of the safest that we have.

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Lives were lost but because of the losses many more lives have subsequently been lived happily and disease free, at least free of diseases spread by contaminated food.

Twenty-five years ago, Riley Detwiler of Bellingham, WA, died, the last of the four children who passed away as a result of the 1993 Jack-in-the-Box E. coli O157:H7 outbreak, sometimes referred to by the Centers for Disease Control and Prevention as the Western states outbreak.

Riley had never eaten a hamburger. He was secondarily infected by a classmate in his preschool who had the infection but his parents did not know it yet.

There had been prior outbreaks from these bacteria, but none as extensive as this one which became infamous and made Bill Marler synonymous with foodborne illnesses.

But the past is behind us, and I want to take a few minutes on this unhappy anniversary to make note of the changes that came about in the world of food safety as a result of it. Lives were lost but because of the losses many more lives have subsequently been lived happily and disease free, at least free of diseases spread by contaminated food.

The industry and the regulators made changes, some of which, in no particular order, were:

1. Probably first and foremost, E. coli O157:H7 was declared an adulterant in ground beef, announced by Mike Taylor, then the acting undersecretary for food safety at the U.S. Department of Agriculture, at an annual meeting of the American Meat Institute, a move which took industry by total surprise. It also assured that the then acting undersecretary for food safety at USDA would never be Senate confirmed.
2. E. coli O157:H7 was upgraded to reportable disease status at all state health departments.
3. After losing a court battle to reverse Taylor’s decision, the meat industry declared that food safety and public health measures were not proprietary properties.
4. Hot steam vacuum treatment of carcasses was invented and refined by scientists at the Meat Animal Research Center in Clay Center, Neb., a very small town boasting more PhDs per capita than any other town in the U.S.
5. Pulse Field Gel Electrophoresis (PFGE) was developed by the Centers for Disease Control (CDC) and shortly became a part of every state health department laboratory performing testing of human specimens in suspected cases of foodborne illnesses. It is also used to fingerprint bacteria grown from meat and poultry samples. PFGE allows what used to appear to be isolated cases of foodborne illnesses to be developed into clusters, enabling investigators to more quickly isolate the cause of the outbreak and regulators to remove contaminated product from stores and hopefully kitchens.
6. Food & Drug Administration increased the recommended temperature for cooking ground beef from 140 degrees F to 155 degrees. The current USDA recommendation is to cook to 160 degrees using a digital thermometer.
7. In 1997, following the Hudson Foods recall, and at the request of Nebraska’s Gov. Ben Nelson, the NCBA created BIFSCo (Beef Industry Food Safety Council). BIFSCo coordinates a broad effort to solve pathogen issues, focusing on research prioritization and information dissemination.
8. Then in 2003, BIFSCo sponsored the first beef safety summit, an annual event since then. At the first summit attendees signed an industry food safety pledge and committed to openly share data and information.
9. The National Cattlemen’s Beef Assn. (NCBA) created a blue ribbon task force headed by old friend Bo Reagan, then with the National Live Stock & Meat Board, a predecessor organization to NCBA where he became vice president of research and knowledge management at NCBA, to fund research into ways to reduce E coli in cattle and slaughterhouses. Bo has since retired from NCBA and now lives just a few miles north of me.
10. The USDA’s Food Safety & Inspection System (FSIS) went from the nearly 100-year-old, sniff-and-poke inspection system to one designed to prevent contamination by invisible pathogens like E. coli O157:H7 called  HACCP, Hazards Analysis and Critical Control Points, that put more of the burden on the individual facilities.
11. FSIS also initiated testing for E coli O157:H7 in ground beef, later moving the testing to combo bins.
12. Industry also ramped up its own testing of ground beef in plants and could remove and cook or discard contaminated runs. Reporting of industry positives and presumptive positives has never been mandated, and few know what the exact contamination rate of ground beef is. FSIS only tests product after industry has tested and removed known problematic ground beef.
13. In spite of criticism from the industry, the FSIS introduced consumer education programs about the potential dangers in ground beef and safe handling and proper cooking instructions. Despite this effort many restaurants’ wait staff continue to this day to ask “How do you want your burger cooked” and my wife and daughter answer “medium.” AARGH!
14. Irradiation of ground beef was made routine by Schwann’s and Omaha Steaks and offered as an option at Wegman’s.
15. Safe Tables Our Priority, affectionately known as STOP, was formed representing mostly families who had lost a child to an E. coli O157:H7 infection but fighting to “prevent Americans from becoming ill and dying from foodborne illness.” The national organization is now known as STOP Foodborne Illness. Nancy Donley, who lost her only child to an E. coli infection, was the president of STOP when I was with the FSIS at USDA.
16. FSIS began identifying retail outlets where contaminated meat and poultry were sold in 2008 to help consumers be more aware if they had eaten contaminated product or still had it in their refrigerator or freezer.
17. Recently, FSIS has begun attempting to trace back to the source when a further downstream processor has a ground beef sample test positive for E. coli O157:H7
18. Six other non-O157 STECs have been added to the list of adulterants in recent years by FSIS.
19. Some packers now use a phage spray on cattle in holding pens, others use hide washes before the knock box to reduce fecal contamination.
20. E. coli vaccines have been developed and gained FDA approval, but are in limited use because of the added cost.

I am certain I have left out a few critical changes, as most were made well before my attention turned from delivering babies to food safety. Please add your thoughts in the comment section.

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The U.S. Codex Office is moving from USDA’s Food Safety and Inspection Service (FSIS) to USDA’s Trade and Foreign Affairs Office and that may not be such a good thing.

The Codex Alimentarius, aka the “Food Code”, is a set of standards, guidelines and codes designed to protect food quality and safety. One example is the safe level of veterinary drug residues in meat and poultry.

The Codex Alimentarius Commission (CAC) consists of 180+ countries, each with one vote, that make the decisions and set the standards that comprise the Codex Alimentarius.

The CAC is co-sponsored by the United Nation’s World Health Organization located in Geneva, and the Food and Agriculture Organization located in Rome. The annual gathering in early July is alternated between the two headquarter cities, but dozens of other sub-committee meetings are held around the world.

It’s a pretty big deal
It is about food safety for all nations, and it is about fair trade. But mostly, it is about public health, and that is not what the Trade and Foreign Affairs Office is going to have front and center on its plate.

I know the nominee to head up this newly created office, Ted McKinney, and he is a good man. But he is not all about public health; he is about marketing agricultural products.

Public health at the USDA is centered in FSIS, and that is where the handful of individuals who work full time on Codex issues are currently located.

The Undersecretary for Food Safety at the USDA chairs the U.S. Codex Policy Committee, a group of high ranking individuals from the EPA, U.S. Trade Office, FDA, Commerce, State and others, making that person the highest ranking food safety official in the U.S. government.

An FSIS employee, Karen Hulebak, was even elected as the chair of the CAC while I was in D.C., a real feather in the USDA’s Codex Office’s cap and an example of how much respect was given to the United States and FSIS, on an international food safety and public health level.

It is a long-standing belief that FSIS is strongly influenced by industry, and puts public health on the back burner. Having been there, I can try to reassure folks that is not the case; but talk only goes so far.

Now that the Secretary of Agriculture and his boss have said they are moving the Codex Office, which is a recognized force worldwide for food safety and protecting public health, over to the Trade Office, that belief will be further enhanced and U.S. leadership on controversial issues reduced.

Are we emphasizing trade goals over food safety? Was the new USDA undersecretary for trade and foreign agriculture affairs the first announced USDA nominee after Secretary Perdue?

The answer to both questions is yes, and is confirmed by the lack of an Undersecretary for food safety who might have advised against this move, and even campaigned in the halls of Congress to maintain the status quo, a status that had very high international respect.

Editor’s note: This column by Richard Raymond, a medical doctor and the former undersecretary for the USDA’s Food Safety and Inspection Service, was originally published by Feedstuffs FoodLink on March 22 and is posted here with permission of the author.

Unless you live under a rock, you probably know that there has been a huge cheese recall going on now for over two months, involving over 130 products and dozens of companies.

The recall began on Feb. 10, 2017, and has gradually expanded as more and more retailers and companies realize the offending product, processed by Deutch Kase Haus LLC in Middleburg, IN, may have been used in their own cheese production process.

The possible contamination is from Listeria monocytogenes, a bacteria found in the environment, not animals’ intestinal tracts, and one that can take 70 days for symptoms to show so, there is no way to know how many people may become ill from eating bad cheese.

Listeria infections are especially dangerous in pregnant women, often causing the death of the fetus.

Despite the huge, far flung recall, the Food and Drug Administration is saying they cannot release the names and locations of stores that sold the recalled products because that is considered “confidential corporate information.”

Says who?

When I was Nebraska’s chief medical officer it did me little to no good when I was informed that the USDA’s Food Safety and Inspection Service (FSIS) was recalling 100,000 pounds of ground beef distributed to grocery stores in Nebraska.

I wanted to know the names of the stores and the towns or cities they were located in so I could advise the local public health departments to go to work informing their residents and protecting their health.

When I was asked to move to D.C. to head up FSIS as its politically appointed undersecretary, I knew I wanted to change the mindset that would not allow FSIS to release “proprietary information,” as the agency referred to the excuse that prevented them from releasing helpful information, or “confidential corporate information” as FDA has labeled the bureaucracy they hide behind on this issue.

I went to D.C. in 2005. The FSIS revised rule on “proprietary information” was posted in the Federal Register in 2008. That is actually pretty fast for Washington D.C., a city of 12 square miles surrounded on all sides by sanity.

Naturally the Grocery Manufacturers Association (GMA) and the American Meat Institute were adamantly opposed to naming outlets possibly selling contaminated meat and poultry, along with many other associations and alliances, but common sense and sanity did actually prevail and now USDA does provide the stores’ names and locations when there is a recall.

Part of my argument for change was that people would not quit shopping at their favorite grocery store if a product was recalled due to contamination that was not the store’s fault. If they kept buying from the same supplier, and kept having recalls, then all bets on customers staying with them would be off.

But that in its self may be a good thing that could produce change in purchasing patterns and safer products.

My other argument was simple: Which is more important, the life of a child or the bottom line on a company’s financial report?

Even GMA did not have a good response to that question.

Of course to win this battle I first had to have the full support of then Secretary of Agriculture Mike Johanns. I had worked for Gov. Johanns in Nebraska as his chief medical officer for six years, so there was more than a little bit of trust built up.

Together we had to persuade the Office of Management and Budget (OMB) to allow the rule making process to proceed to fruition.

The moment that agreement occurred was actually on “a dark and stormy night” as the top OMB official and myself, along with many others, sat in a hanger at Andrews Air Force Base waiting for a thunderstorm to pass so we could fly to Belgium for high level talks with the European Union.

It is a long story that I won’t go into, but I doubt I would have ever gotten her undivided attention the way I was able to get it that evening without the lightening delaying the flight.

So what is the “clause in the Federal Code” that FDA says has them gagged, while others may actually be gagging on contaminated cheese?

Several reporters and writers have asked me that question, and I have no answer other than it seems to me that USDA/FSIS blazed the trail and FDA finds it easier to sit by the camp fire rather than follow the trail and the fights that come with it.

So I will close with a few questions for you to ponder:

• How can corporations claim confidentiality while potentially causing miscarriages and deaths?
• How can FDA, a federal agency housed within the Department of Health and Human Services, not fight for the right of the fetus to live a healthy life?

After all, it is Health and Human Services, not Commerce, right?

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For additional information on the related recalls, please see:

• “Another 130 cheese products recalled for Listeria; FDA gagged”
• “Saputa pulls gouda from stores in latest Listeria recall”
• “String of cheese recalls continues, as does Listeria probe”
• “Guggisberg Cheese recalls a dozen products because of Listeria”
• “Sara Lee recalls cheese; 3rd-party plant has history of Listeria”
• “Taylor Farms recalls Signature, HEB salads; Listeria in cheese”
• “UPDATED: Listeria in cheese; recalls by Sargento, Meijer, others”

1. Dual jurisdiction plants are those that fall under both FDA and USDA/FSIS regulatory authorities.
2. FSIS regulates the slaughter and further processing of meat, poultry and egg products and does this by daily, continuous inspection of these establishments as dictated by various statutes passed over the years.
3. FDA basically is responsible for almost everything else, including seafood, fish, dairy, shell eggs and produce. They rarely inspect a plant and may audit every five to 10 years or so.
4. There are two glaring exceptions to No. 2 and No. 3 that were created by Congress, not by the agencies. FSIS has catfish inspection but no other seafood or fish. FDA has authority for bison but no other four-legged animals. (In fairness to the bison industry, and so Dave Carter does not call me, bison producers can ask for federal inspection, but they have to pay for it.)

What happens in the dual jurisdiction plants is that some products are produced that contain meat and some do not. The ones with a minimum amount of meat get daily continuous FSIS inspection; those with no meat might be the subject of an every 10 year or so audit. Vegetarian pizza vs. pepperoni pizza Pea Soup vs. Chicken Noodle Soup Gerber carrot baby food vs. Gerber beef baby food But it is not that simple. Bagel Dogs vs. Corn Dogs Closed face, ready-to-eat turkey sandwich vs. open-faced turkey sandwich Same exact product and risk, yet one gets daily continuous inspection and the other gets none. And Congress wants a memorandum of understanding to prevent duplicative inspection oversight? It is not duplicative; it is almost all FSIS. You are not going to see FSIS and FDA inspectors hanging around together in these establishments. And Congress wants to be assured that inspection in dual jurisdiction facilities by FSIS meets the requirements of FDA? What FDA requirements, Congress? Maybe the one that is in the Food Safety Modernization Act and says FDA oversight must be risk-based? Well, Congress, if that is the FDA requirement you are thinking that FSIS must meet, then you must change a law you passed in 2008 that said FSIS could not spend one more tax dollar developing a risk-based inspection system. As U.S. Sen. Tom Coburn, (R-OK) said in 2011 regarding the dual jurisdiction issue, “First of all, it is stupid. Second of all, it is inefficient.” He was right. So why won’t Congress fix it? Three reasons:

1. The consumer and food safety advocates want FDA products in dual jurisdiction plants to get daily inspection also.
2. The meat and poultry industry wants to be exempted from daily inspection for things like soup, sandwiches and pizzas containing meat.
3. The bargaining unit wants nothing that would decrease their numbers.

FDA and FSIS held a joint public conference in Chicago on this issue on Dec. 15, 2005. Bob Brackett and I co-chaired it. In my naiveté, I thought this would be an easy fix. The conference showed me how polarized this issue is. Hence, Congress is not going to wade into this food fight but instead is telling the two agencies to play nicely together and take their lumps as they most surely will come from all sides. If I were king for a day and wanted to get rid of this embarrassing inspection situation, here is what I would do. First of all, give FSIS all animals, including fish, seafood, eggs, and, yes, bison. And give them all animal products such as milk and cheese. Give FDA all products that contain meat or poultry that has already been inspected in the pens, in the slaughter plants and in the further processing plants. After all, you can only inspect chicken meat so many times before you have to say “good to go out the door.” Adding chicken meat to a pizza crust that contains tomatoes from Mexico, spinach from California, onions from Guatemala and cheese from Wisconsin does not immediately turn that pizza into a killer dish. I think this would be near budget-neutral, cost no bargaining unit jobs, and make our food safer. At the very least, it would make the system look less “stupid” and be more “efficient.” Last shot and I am out of here. Farm Bill 2008 is the statute that actually moved catfish to FSIS with the help of U.S. Sen. Thad Cochran (R-MS). Six years later, and they are still not inspected. Seems the rule-makers are hung up over the definition of catfish. I would not hold your breath waiting for the mandated memorandum of understanding.

Last week, James H. Hodges, Executive Vice-President at the American Meat Institute (AMI), ostensibly penned an opinion piece for Food Safety News titled “Wrestling  With the Science of STEC”. You can read it here.  But in case you are not inclined to go back to the original article, let us enlighten you with some quotes from it and our thoughts.

Jim starts out with “When it comes to our nation’s Shiga toxin-producing Escherichia coli (STEC) policy, some people like to wrestle in the mud. I like to wrestle with the science.” Ouch.

Is he talking about previous OpEds that Food Safety News has published, or is he referring to Bill Marler and his petition for the USDA to declare non-O157 STECs to be adulterants in meat?

Or maybe he is accusing our Undersecretary for Food Safety at the U.S. Department of Agriculture, Elisabeth Hagen, a highly respected M.D. who has relied upon science to make informed decisions her entire professional life, of being a mud wrestler?

First of all, whenever meat industry representatives state that their policies and/or opposition to federal regulations are “based on science” we see more red flags than Khrushchev ever did.

And we are not alone. While we do not necessarily endorse every statement made by Marion Nestle, her book, “Safe Food: The Politics of Food Safety,” has some quotes that resonate with our thoughts:

Page 16: “This book explains how food companies use science as a political tool to oppose requirements to keep harmful microbes out of food.”

Page 22: “In this book, we will see how the failure of food companies, scientists and governmental agencies to recognize the need to address VALUES (emphasis added) as well as science in matters of food safety leads to widespread distrust of the food industry…”  

Mr. Hodges, we suggest that public health obtains, and the average consumer sees, intrinsic VALUE in not having poop in our meat.

Page 30: “We will see how food producers repeatedly deny responsibility for foodborne illness, invoke science to promote self-interest and divert public attention from harm caused by their products…” 

When AMI cannot defend its positions or policies, it simply tries to stifle debate or discussion by hiding behind its definition of “science,” while invoking that term to prematurely terminate any meaningful discussion.  Even the most constructive discussions of food safety rules, including microbial testing, are commonly attempted to be discredited by a default appeal to “science.”

It is our joint goal today to keep the discussion alive and ongoing regarding the testing for non-O157 STEC by FSIS. 

Mr. Hodges, in his piece invoking science, says that, despite the new knowledge that non-O157 STECs cause more illnesses per year than O157s, “most of those illnesses were actually sourced from foods other than beef.” Really, Mr. Hodges, do you have something based on science to defend this statement?

The Centers for Disease Control and Prevention, a highly respected science-based institution, is on record as saying that 80 percent of foodborne illnesses never have the source of the illnesses determined. And for non-O157 STECs that percentage is even higher, due to the simple science-based fact that these illnesses are tremendously underdiagnosed and underreported.

So seriously, Mr. Hodges, how can you say you know the majority of illnesses are “from foods other than beef” when the CDC itself cannot and will not make that statement? 

Nowhere in his submitted opinion piece does the AMI spokesperson acknowledge the outbreak of illnesses that sickened 100 and killed four in Japan, an outbreak caused by eating beef steak harboring one of the six STECs that FSIS has declared to be adulterants in ground beef.

Dr. Hagen has repeatedly said that she is all about prevention of foodborne illnesses, as opposed to reaction to illnesses. This is a laudable step to prevent illnesses and deaths like we saw in Japan.

And we feel we must remind Food Safety News readers that this is the same AMI that filed a lawsuit in 1994 to prevent FSIS from moving forward to take positive action to protect our health after Mike Taylor declared E. coli O157:H7 to be an adulterant in ground beef following the Jack in the Box outbreak.

We assume that lawsuit was based on their “science,” but can you imagine how many more children would have died between then and now from eating ground beef products if AMI had been successful and the industry had not rolled up their sleeves and attacked the problem with real science-based interventions?

By the way, in case you were wondering, yes, James H. Hodges was employed at AMI at the time the lawsuit was filed in 1994.

We can’t help ourselves. We must point out this quote Mr. Hodges offered up in support of his science-based approach to food safety: “As it is, the evidence suggests that contamination with these serotypes is prevented or eliminated by exactly the same interventions that are currently in place to prevent or eliminate O157 STEC contamination.”  The quote is from “Peer Reviewer 1, FSIS Draft Risk Profile:”

No name is even offered up for the quote, one of three in the opinion piece. But we would NEVER quote a source that says the current interventions in place “prevent or eliminate O157 STEC contamination.”  The interventions in place do reduce contamination, but they most certainly do not prevent or eliminate.

We are glad the industry has made such great strides in reducing our risk. But if the non-O157 STECs are actually “eliminated” by current interventions, then AMI members should have nothing to worry about from additional testing, right?

Semantics, yes, but if one wants to stand behind science as his shield, he had better be sure of his facts and state them clearly.

In conversations with directors of public health laboratories on the cutting edge, we hear that they are seeing at least as many positives for non-O157 STECs in specimen samples from humans suffering from foodborne infection as they are seeing for O157s. As more labs test, and as more cases are reported, we will find the move by FSIS to be truly prescient and an action that will have prevented illnesses and deaths without the need for a Jack in the Box or Japanese-like catalyst.

Jim says “we must remain valiant” in what we assume is a reference to AMI and its members. Valiant is described in the World Book Dictionary as: “having courage; brave; courageous.”

We think Undersecretary Hagen and FSIS Administrator Al Almanza are the ones who “must remain valiant” in the next few months.

Maybe the word he was searching for is “vigilant”?

In fairness to Mr. Hodges, we are assuming he did not actually write this opinion piece.  We do invite him to respond, to clarify its authorship.

———————–

John Munsell, who ran a USDA-inspected meat plant for 34 years, now oversees the Foundation for Accountability in Regulatory Enforcement, FARE. Dr. Richard Raymond is the former Undersecretary for Food Safety, U.S. Department of Agriculture (2005-2008) who now works as a food safety and public health consultant.

The General Accountability Office (GAO) released a 345-page report to Congress in March, 2011, that proposed changes in efficiencies in federal programs that would save us tax payers $200,000,000,000. I will confess I have not and will not read the entire report. My interests are limited to the 4-5 pages in the report on food safety.

In those few pages, the GAO calls for a single food safety agency at the federal level, but the $200 billion in savings is not impacted by this suggestion. Their proposal for a single food safety system is budget neutral.

And herein lies the rub. Meat and poultry plants must have daily, continuous inspection to operate. It is the law. If a single food safety agency combines employees, duties and dollars, FDA can do nothing more than it is currently doing. Nothing will change.

Food Safety News posted an op-ed by me on Monday, Jan. 16, that was in opposition to a single food safety agency. Since I have publicly professed to detest complainers who bring nothing to the table to solve problems, here are my thoughts on what real change could look like and still be budget neutral: 

The GAO report cites the massive Iowa-based Salmonella egg recall and outbreak as a perfect example of the fragmented food safety inspection system, and it is a great example.

But it does not take a single food safety system to place all eggs under the USDA. Congress “scrambled” the egg inspection system back in 1970 when it passed the Egg Products Inspection Act that gave egg products to the USDA and shell eggs to the FDA. They can unscramble this situation by putting all eggs under the USDA. Simple move, no mess, and it would address a problem that became elevated in the public’s eye in 2010.

They can also put all animals, including bison, fish and seafood, under the USDA and add all products from animals to the USDA list. That would bring all dairy products, eggs and even casings under USDA/FSIS daily continuous inspection.

Currently casings (animal intestines), all fish except catfish, and bison, unless they pay for FSIS inspection, are under FDA’s regulatory authority. Yes, by law FSIS has catfish but not bison. See, we don’t need a massive single food safety agency to correct these silly deficiencies. We just need some common sense.

Congress could also say that any meat or poultry product that has been inspected at least twice and cooked as a final kill step under FSIS inspection does not need to be inspected again when used to make soup, flavorings, baby food, packaged sandwiches, pizzas etc.

There is currently a system called dual jurisdiction at work in many facilities. Let’s look at pizza as just one example.

A company makes frozen vegetarian pizza and gets no inspection by FDA. Add shrimp and still no inspection. The tomatoes may come from Mexico, the peppers from Chile, the onions from Guatemala and the shrimp from Thailand.

Add a little pepperoni from an American plant, pepperoni with the USDA mark of inspection on it, and you add the need for daily, continuous FSIS inspection — but just for the conveyor belt carrying the pepperoni pizza.

Same goes for canned soup, baby food, etc. It is gross overkill to require inspection for chicken noodle soup but not for tomato soup, and it has nothing to do with protecting the public’s health.

The inspection system is totally arbitrary when it comes to corn dogs and bagel dogs, open-face and closed-face sandwiches. Exactly the same product, just different packaging, resulting in either no inspection or daily inspection.

I don’t know for certain, but I believe that if USDA removed all the inspectors at the dual jurisdiction plants and put them to work on fish and seafood, eggs and dairy products inspection, it would not only make those products safer, but would probably not increase the cost of food safety.

Nearly 80 percent of all the fish and seafood we consume is imported. Almost none is inspected as it arrives in this country, and certainly the number of countries exporting these products is not limited in any way.

If under USDA authority, these countries would first have to have an equivalent food safety system, including daily, continuous federal inspection. Then they would be subjected to annual audits, and the products they export to the U.S. would be re-inspected at an FSIS import house. Just like meat and poultry are today. Food safety would be improved, and the cost is covered by not having vegetable beef soup receive a level of inspection that is simply not needed.

Laws mandating daily, continuous inspection for meat and poultry were passed many decades ago, long before PulseNet (the national surveillance system for foodborne outbreaks) and improved epidemiology revealed that many foodborne illnesses are from produce and other sources, and that meat and poultry are not necessarily the most important carriers of pathogens that can kill us.

We need change, with this I agree, but we do not need change that substantially increases cost and does not increase efficiencies and effectiveness in the federal food safety system. 

We should not waste time and effort on a single food safety agency that Congress and many food safety experts simply will not support, but instead we should focus on who should do what and why and, as another Nebraskan is famous for saying,  just “git ‘er done.”

This possible move is not totally unexpected from this Administration, nor was the way the Office of Management and Budget’s (OMB) thinking was leaked to The Hagstrom Report by a consumer advocate a surprise. What is a surprise to me is that Food & Water Watch was the only consumer advocacy group quoted in the report, which basically fingers them as the leak.

The consumer advocate is reported to have said that the OMB wants to move the Food Safety and Inspection Service (FSIS), currently located in the U.S. Department of Agriculture on the nation’s Mall, north to Maryland to become part of the Food and Drug Administration (FDA), which is a branch of the Department of Health and Human Services.

Most consumer groups will support this move if it develops, although Food & Water Watch said it would  “urge against consolidating food safety functions” at this time.

A strong proponent of such a move will be Mike Taylor, a former acting Undersecretary for Food Safety at the USDA and the current Deputy Commissioner for Foods at the FDA. Mike and I appeared together on many panels debating food safety in 2007-2008 and at every opportunity he advocated for a single food safety agency located “anywhere but at the USDA.” 

Caroline Smith-DeWaal , Director of Food Safety at Center of Science in the Public Interest, also joined us in several panels and is another strong proponent for a single food safety agency. And the list goes on.

It is my sincere belief that a merger of the two food safety agencies would be an unmitigated disaster in the short term because the cultures are so very different. And unless megadollars flowed with the merger, nothing more could be accomplished than is currently done. 

And there are dozens of other valid reasons to “just say no” to the Administration’s thinking.

If you have not yet clicked on the link provided in the first paragraph, do so now to better understand why I am afraid of this proposal, as is Carol Tucker-Foreman, who responded to the article with an in-depth comment, a spot-on discussion of why this talk is so scary to those who know the players. 

FSIS regulates by inspection and enforcement. Their daily presence in nearly every single meat and poultry plant in this country is mandated by law and funded by Congress. They can shutter a plant simply by having the inspectors not show up for work.

FDA regulates by education and writing Good Manufacturing Practices and suggesting policies to follow when producing food. Foods like sprouts, cantaloupe, peanut butter and shell eggs come to mind. And FDA inspection is either by a state entity, a third-party auditor paid by the company or themselves when an outbreak is recognized.

The FDA has no mandate in inspection or audit frequency, and very little in funding to do so. And therefore they very rarely inspect or audit unless a disaster mandates it.

This is not to say one agency is better than the other. They are very different entities, and the laws that they follow are very different also. To blend them into one might be like mixing oil and water.

And that brings me to personalities. There has been some obvious tension and conflict between the two agencies and some of their leaders for decades. Those feelings will not disappear with a Presidential mandate.

A very simple example of this is the dual jurisdiction plants. It should be simple to decide if all pizza should be inspected daily, if no pizza needs inspection, or if we should just inspect pizza with meat on it. The same could be said for soups and baby foods. But alas, it is not simple. And a single food safety agency will not change the laws that allow this ridiculous situation to continue. 

It is often said by those wanting a single food safety agency that there are anywhere from 12-17 agencies involved in food safety. But in reality, 99.9 percent of what we eat is regulated by either FSIS or FDA.

Unless you count alcohol as one of your six basic food types, I do not know why the Bureau of Alcohol, Tobacco and Firearms keeps showing up on these lists. Or the EPA, which does have the ability to shut down Gulf Coast commercial fishing when there is an oil spill, but most of our fish comes from overseas anyway. 

The story in Food Safety News mentioned that Obama’s plan includes moving the National Oceanic and Atmospheric Administration, or NOAA, from the Commerce Department to Interior and bringing “all salmon regulation into one agency.”

I think NOAA just has marine authority for fishing regulations, certainly not commercial salmon farming, or fresh water salmon fishing. And it gets even more convoluted when Congress, in the 2008 Farm Bill, mandated that catfish inspection move from FDA to FSIS, but left all other fish and seafood at FDA.

The Food Safety New story also said that “Obama administration officials are said to favor the merger because it would make food safety independent of USDA, which primarily exists to market and promote American farm products.”

There are seven Mission Areas within the USDA. The five Undersecretaries for Food Safety; Food Nutrition and Consumer Services; Rural Development; Natural Resources and Environment;  and Research, Education and Economic will tell you they do not “primarily exist to market and promote American farm products.”

One might argue, based on prior observations, that the Food and Drug Administration primarily exists to regulate medicines and medical devices.

Single Food Safety Agency. Sounds good, but guess what? We had a single food safety agency from 1906, when the Federal Meat Inspection Act and the Pure Food and Drug Acts were passed. USDA had all the authority for food safety. 

The FDA was transferred out of the USDA in 1940. A single food safety agency must not have been perceived to be working out too well back then.

Some would say mega-bureaucracies lose the nimbleness necessary to respond to outbreaks and other emergencies. Agencies like the Department of Homeland Security come to mind.

Maybe the scariest thing about this whole idea of a single food safety agency, located at FDA is that Carol Tucker-Foreman and I agree that it is a bad idea. We don’t agree on too much, so when we do, it must be a really good idea (non-O157 STECs as adulterants in beef, for example) or a really bad idea (single food safety agency at FDA).

,

In recent weeks she has had two opinion pieces on the evil McDonald’s empire that is preying on kids by offering toys in their Happy Meals, and another piece on the cereal industry’s awful attempt to get kids to eat their product by adding sugar and using advertising catering to kids like Tony the Tiger.

Last week (Dec 19) in the opinion piece titled “Congress to Kids: Drop Dead” Michele added                     Kool-Aid to her list of “sugar atrocities.”

And in the same piece Ms. Simon attacked some Republican Presidents of the past as being an additional part of the evil empire that is in bed with “Big Food.”

I have had conversations with Michele, and I respect her right to have her own opinions, such as when I advised her that if everyone believed like she does that we should ban Concentrated Animal Feeding Operations (CAFOs), a lot of the world’s children would not be able to afford meat.

Her reply: “And that would be a good thing.”

So I know where she is coming from, and since I write several blogs a month, I know they can stir up the masses.  But I find myself today just having to respond to try and get some facts on the table. And maybe add an opinion or two of my own.

First of all, Kool-Aid was invented by Edward Perkins in his mother’s kitchen in Hastings, NE, in 1927. I was not alive then, but I did go to school in Hastings, as did my three sisters. We “drank the Kool-Aid” and we survived. 

And by the way, Michelle did not tell us that Kool-Aid does sell a sugar-free product that comes in many different flavors. It is usually the parent’s choice what product they buy. Kraft has provided them a choice.

Sugar Frosted Flakes and its mascot, Tony the Tiger, came into being in 1951. And the company put toys in the box to entice young children at the time to beg their moms to buy them. I did, and I survived.

Ray Kroc opened his first McDonald’s in 1955. But I never saw one in Nebraska until much later.

Fast foods, toys in the packaging and sugary cereals are not new, but the obesity epidemic is new.

What are newer than these foods and the marketing of them to kids are things like computers in the shapes of Lightning McQueen and Dora, DVDs playing Thomas the Train movies, hand held Game Boys and Facebook.

Talk about marketing to children. But one could argue that children are becoming more sedentary thanks to electronics.

A person’s body fat content is almost always a simple result of the difference between calories ingested and calories spent. I ate all those “sugar atrocities” growing up (still do) but I burned off enough calories to graduate from high school weighing 165 pounds.

So now on to subject of the “attack” on Republican Presidents in the Dec. 19 Simon opinion piece.

Michele is lamenting the fact that a cost/benefit analysis is needed before a final report can be released that will give the food industry “science-based nutrition guidelines for marketing to children.”

In the commentary, it is strongly implied that “a nasty right-wing deregulation policy that dates back (surprise!) to the Reagan administration” is what is holding up the process. The next sentence then blames the Office of Information and Regulatory Affairs (OIRA) for killing proposed rules over the years, implying that this is all Reagan’s fault.

Reading further, “Since Ronald Reagan opened the OIRA office in 1981, Republicans have used it to particular advantage to pursue anti-regulatory agenda….”

I am not a lawyer, nor a student of politics, but OIRA came about as a part of the Paperwork Reduction Act of 1980, passed by our 104th Congress, while Jimmy Carter was the sitting President. Reagan came into office in 1981, so he may have been there when OIRA first opened its doors, but the origination came under a Democratic administration.

OIRA is a part of the Office of Management and Budget (OMB), which is located within the Executive Office of the President of the United States.

Additionally, for readers who had never heard of OIRA until reading Michele’s story, or like me went to work in D.C. having never heard of it until I bumped up against it, the Administrator of OIRA is a presidential nominee, Senate-confirmed. Cass Sunstein currently sits in that chair, and works for the President himself. 

Simply put, if you are blaming OIRA for something, then you are blaming the President. You are blaming the current President, that is, not Ronald Reagan who inherited OIRA from President Carter.

Opinions are usually free, so here is mine for the day. Food safety is not and should not be political. Both Republican and Democratic Presidents and Congresses have attempted to make our food safer. They may have differing views of how to get to the next step, but we do not slip backwards under Republican Administrations as implied in many blogs and OpEd pieces.

On Dec. 22 a Food Safety News article by D.C. correspondent Helena Bottemiller told how the White House Food Safety Working Group had released a 28-page report touting “Progress on Food Safety.”

This is what White Houses do, especially as election time nears. It is an impressive 28-page document. What it does not do, however, is note that many of the claims made are actually the result of initiatives that began during the Bush Administration.

These are initiatives like the Salmonella Improvement Plan and the Public Health Information System. PulseNet started in 1996 and changed the world of food safety by identifying outbreaks much more quickly and much more accurately than ever before. If you did not know that, you might come to the conclusion after reading the report that it was initiated by this administration.

I can only hope that the next President voted into office in November, 2012, agrees that food safety is not political, and that he proves that point by asking Dr. Hagen to continue on as the Undersecretary for Food Safety at the U.S. Department of Agriculture under a Republican administration.

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.

Before pasteurization of milk (heating to a certain temperature designed to kill any organisms present) became more or less the norm in the 1930s in the U.S., milk in this country was linked to over 25 percent of food and water borne illness outbreaks and many infant deaths. Now milk is responsible for less than 1 percent of foodborne outbreaks. But it could and should be less than 0.1 percent because nearly all milk-related outbreaks are from raw milk and cheese made from raw milk.

The leading milk related human illnesses before pasteurization were brucellosis, diphtheria and bovine tuberculosis, three diseases now well-controlled or virtually eliminated in modern dairy herds in the U.S., but still present in some other countries. Because of the control of these organisms, some feel that pasteurization is no longer necessary to get good, wholesome, safe milk. But they are wrong. And their children are paying a price.

As I stated, the number of outbreaks linked to raw milk has been climbing recently. Between 1998 and 2008, the CDC identified 85 outbreaks from drinking raw milk. In 2010 alone, the number was over a dozen outbreaks. The great majority of raw milk victims are children under the age of 18.

Of course the illnesses today are not tuberculosis or diphtheria, but are caused by Salmonella, E. coli O157:H7 and Campylobacter, bacteria found in the intestines of many feed animals. No matter how hard the dairy farmer may try, cows and goats live in an environment loaded with manure and sterilization of the milking environment is one tough, impossible task.

There may be more than two reasons for this increase in outbreaks, but here are two that immediately come to my mind.

First, we have better attribution due to better epidemiology and the creation of PulseNet that can help link seemingly unrelated illnesses.

Secondly, we are seeing a push for buying locally and “knowing your local farmer” as a result of media stories about the dangers inherent in certain mass-produced foods, whether true or not. But whether buying locally is safer and healthier or not is a debate for another day.

My guess is that the 30 or more people poisoned in the 11th raw milk related outbreak in 2010, who “bought” goats’ milk from the Billy Goat Dairy in nearby Longmont, CO, and then became ill with Campylobacter and/or E. coli 0157:H7, including the two with hemolytic uremic syndrome, are probably questioning if “knowing your farmer” and buying “locally” is really safer or not.  The kids who were sickened might be questioning their parents’ intelligence.

In Colorado, it is illegal to sell raw, unpasteurized goats’ or cows’ milk, but the people who fell ill and the farmer got around this by what is called the Goat Share Program. You buy a share of a goat (or cow) for a set price and get a set amount of milk in return. And you pay a “boarding fee” on top of that to cover the farmers’ costs and labor. So it is technically your goat, I guess, and therefore you are not violating the law by “buying milk.”

Laws are written for a reason, usually to help keep us safe. Parents who find ways to circumvent the laws should be held responsible when their children suffer because of their actions.

That said, I do believe people should have the right to purchase what they want, as long as it is legal. But I also know that the CDC, the Food and Drug Administration and nearly every other public health organization do not endorse consuming raw milk.

But to buy this product and feed it to your children? Might as well lock them in your car on a 100 degree day while you stop by the casino to try and win the jackpot.

So why did I write this story about a person’s right to eat or drink what s/he wants? Two reasons.

First, the kids who fall ill — and they seem to be the ones always hit the hardest and hospitalized — did not really make an informed choice. Their parents made that choice for them.

Because parents and other adults do not always make the right choice for their kids, we have laws that protect children by requiring childhood immunizations, requiring child restraints in cars, requiring smoke-free public buildings and restaurants, and banning the purchase of liquor for consumption by children.

It should also be against the law to purchase unpasteurized milk for consumption by children.  Period.

Second, I want the same choice when I buy beef. I want to choose between pasteurized and unpasteurized. But I don’t have that choice because of the opposition by consumer groups to whole carcass, low dose, irradiation of beef.

For those who rely on the Internet, accurate nor not, for their informed sources, I suggest a milk related web site that is based on science and facts: www.realrawmilkfacts.com

There are those who say they might be just as likely to be stricken with a foodborne illness by eating spinach or ground beef. That may be true, but those products do not have a proven kill step yet, and milk does. To not use this technology to our advantage to protect our children from unnecessary suffering or death should be considered criminal.

Pasteurization of milk has saved thousands of infant lives, and despite the historical difficulty in getting pasteurization to be routine it is now accepted and demanded by over 97 percent of Americans. The increasing number of outbreaks linked to raw milk is a painful reminder of how successful pasteurization has been in preventing unnecessary foodborne illnesses.

Pasteurization of beef carcasses would also save thousands of lives and we should be demanding we have that choice. Some day our grandchildren will look back and wonder how we could have been so ignorant to drink unpasteurized milk and eat unpasteurized beef.

———————-

Dr. Richard Raymond is the former Undersecretary for Food Safety, U.S. Department of Agriculture (2005-2008) who works as a food safety and public health consultant.

That question seems to have been put out there for public debate in quotes attributed to Betsy Booren of the American Meat Institute (AMI) Foundation in a recent USA Today story by Elizabeth Weise that can be read here.
 

The story was about E. coli O157:H7 being the only deadly strain of E. coli to be declared an adulterant and therefore illegal. It also raised the question of why other strains were OK, even if they could make you sick or even kill you, as we recently saw happen in Japan and Europe.

Naturally Ms. Weise, in an effort to write a fair story, interviewed Ms. Booren of AMI. I think the statements she got in that interview bear a closer look.  I also think that regardless of where the reader stands on the issue of non-O157 STECs that can cause human illnesses being declared adulterants in ground beef, one really has to question the science behind the following quotes from USA Today:

“The meat industry says it’s too early to declare the various dangerous E. coli subtypes as adulterants.

‘We don’t have a true baseline determining the prevalence of these organisms in the beef supply,’ says Betsy Booren of the American Meat Institute (AMI) Foundation, the research arm of AMI. Without knowing how common they are, it’s impossible to say whether they should be considered adulterants, she says.

AMI believes that testing for E. coli O157:H7 in many ways takes the place of testing for a broader range of E. coli variants, because if you get a positive for E. coli O157:H7, you know there’s been fecal contamination and so other variants might be there as well.” 

Three small paragraphs, four very debatable and very puzzling statements. This type of PR work in the media really does not help the public image of the meat trade association that represents the majority of our largest meat packers and processors.

“Too early to declare” non-O157 STECs adulterants? Think Japan and Europe and this statement wilts away. What are we waiting for, the re-incarnation of the “Western States Outbreak” as CDC refers to the 1993 Jack in the Box event? 

“We don’t have a true baseline”? EIH laboratories have one, the USDA Meat Animal Research Center in Clay Center, NE, has one, and Texas Tech now has one. USDA/FSIS announced that they were going to test meat for non-O157 STECs in May, 2008, so they have a baseline. Maybe Ms. Booren meant the AMI Foundation has not done their testing yet?

Whose baseline to use may be debatable, but the next two statements really bother me when spoken by an AMI spokesperson supposedly representing the thinking of the meat industry.

“It’s impossible to say whether they should be adulterants, she says” unless we know how much meat is contaminated with them. What difference does it make if 2% or 20% of chubs are contaminated with non-O157 STECS? Do we really need another 700 people sickened and 4 killed to say we guess there is enough contamination to declare them to be adulterants? 

Any amount of bacteria that can kill you is enough to say that meat is adulterated and must not go to retail as fresh, raw ground product. 

The definition of adulteration can be found at 21 USC & 601 which clearly states:

“(m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(l) if it bears or contains any poisonous or deleterious substance which may render it injurious to health”

No mention of how many pathogens must be in a pound of ground beef, just if it is enough to make it injurious to my health. No mention of the need for a base line to determine prevalence rates for a poisonous substance, just the need to determine if it could be injurious to my health.

Does anyone else consider it strange that most of the recalls we are seeing are for undeclared allergens? I know it is important for persons with food allergies to know what they are eating, but how many illnesses are found to be due to allergens compared to non-O157 STECs?

But back to the USA Today story and the fourth statement attributed to Betsy Booren that really made me question her science background, or at least her Association’s promise to always put the public’s health first. The news story states that AMI believes you don’t need to test for non-O157 STECs because testing for O157:H7 is sufficient.

I agree with the logical statement attributed to Betsy that if meat is positive for O157 you know you have fecal contamination, and we all know that is not a good thing to have.

But having a negative for O157 cannot even assure you that your meat does not contain E. coli O157:H7, much less some other pathogens found in feces of cattle. WE ALL KNOW THAT. Well, maybe all except Ms. Booren.

We try and hammer home the message to consumers to handle and cook their meat according to recommendations because raw meat should never be considered sterile, no matter how much testing has been done.  AMI has said publicly many times that we cannot test our way to 100% safe ground beef.

Yet it is implied by the spokesperson for AMI that if the meat has tested negative for O157 we do not need to worry about contamination with non-O157 STECs. I thought this must be a typo, but have been reassured this is what AMI’s position is.

AMI, just because a cow did not have O157 in his or her gut does not mean the animal was not inhabited with E. coli O111, or O145, or maybe even O104. AMI, just because testing of the ground beef sample did not detect O157 does not mean there are not other fecal pathogens present.

This is really pretty simple stuff I am talking about here. If we don’t test, we won’t find lethal bacteria. And we won’t have to divert the contaminated and adulterated product to cooking, helping maintain its economic value.

But if we take Ms. Booren’s position about E. coli being a sentinel for fecal contamination and no other tests are needed, then why do we do both Salmonella and O157 testing in beef, and why are we establishing standards for both Campylobacter and Salmonella in poultry?

There might be one small positive from the story. Maybe FSIS can survive the projected food safety budget cuts by discontinuing the current policy of unnecessary and duplicative testing (as implied by Ms. Booren) for different fecal pathogens.  

One of the best reads on the subject, and a book I quote and refer to often, is John P. Kotter’s 1996 edition titled “Leading Change.”

Kotter lists eight necessities to “drive people out of their comfort zones.” He says the first necessity to create change, and without it he suggests you don’t even try, is that you must have or “create a sense of urgency.”

When the discussions of what to do about non-O157 STECs (Shiga-toxin producing E. coli) first began, there was no sense of urgency. In fact, we believed they were relatively uncommon and not nearly as virulent as the banned E coli O157:H7.

So we planned and held conferences to discuss the pathogens, and we began testing meat to get a better idea of the frequency. We began developing better tests for industry and regulators to rely on, and more public health laboratories began including tests for non-O157 STECs on specimens from persons thought to be suffering from a foodborne illness.

As the testing became better, and more frequent, we began to realize these pathogens were in our meat and were causing foodborne illnesses much more frequently than once thought. Carol Tucker-Foreman and I penned an OpEd piece for Food Safety News to bring everyone up to date (we thought) on these emerging pathogens. www.foodsafetynews.com/2011/05/its-time-to-move-the-needle-on-non-o157h7-stecs/ 

But still no “sense of urgency” existed. The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) sent a proposal to the President’s Office of Management and Budget (OMB)in January of 2011 on what to do about the Big Six non-O157 STECs, the Big Six at that time being the most prevalent of non-O157 STECs causing illnesses in the U.S.

I don’t know exactly what is in the proposal, but no one has denied that it will be to conduct rule making to declare the Big Six as adulterants, as defined by the Federal Meat Inspection Act. Rule making takes two years at the very least to become enforceable. Much longer if there is industry opposition or trade implications.

But FSIS has alternatives to the formal, transparent and drawn out rule making process.

In 1993 the Jack in the Box outbreak sickened hundreds and left four children dead from eating ground beef containing E. coli O157:H7. At the time, this was one of the largest outbreaks from E. coli ever. It created a “sense of urgency”.

Soon thereafter, in 1994, Mike Taylor, then Acting Undersecretary for Food Safety at the USDA, using the power of his office and the Federal Meat Inspection Act, declared E. coli O157:H7 to be an adulterant in ground beef. Creating this change to make our food safer took months, not years.

In December of 2003, when the Washington state cow was found to have “Mad Cow Disease”, FSIS wrote Interim Rules in weeks that defined how we would assure our international trade partners and our domestic consumers of beef that they were safe. Years later the official, open and transparent rule making process made these amended interim rules final rules.

 The industry had a “sense of urgency” even if the actual human health risk was extremely small.

Anyone not living on a deserted island knows Europe now has a “sense of urgency” regarding non-O157:H7 STECs, specifically O104:H4, and so did Japan with O111 a few weeks ago. In Germany we have been told there are thousands ill, hundreds with hemolytic uremic syndrome and dozens dead. Jack in the Box pales in comparison to what we are seeing right now.

But for some in the U.S., there still is no “sense of urgency.” The Centers for Disease Control, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture held a joint teleconference last Friday to discuss the situation in Europe with reporters and other selected individuals.

On that call, Don Kraemer, Deputy Director of the FDA’s Center for Food Safety and Applied Nutrition, said that they won’t be moving any faster to write new rules under the Food Safety Modernization Act because they were already working as fast as they could. A USDA spokesperson echoed that sentiment, saying it was a complex issue with lots of viewpoints to be considered.

If that outbreak had occurred In the States, I have no doubt both organizations would be working much harder and faster. You can always work faster, it is just a matter of “urgency” and prioritization.

Congressman Waxman and others are now asking for a Congressional hearing on the subject of the outbreak in Europe, and what we are going to do to protect Americans from a similar disaster. The last thing we need is for our high ranking food safety officials to have to take the time to prepare for a hearing, and then have Congress write food safety laws regarding non-O157 STECs.

Instead, these same food safety officials should seize the moment and do something right now to ensure the safety of our food supply.  They have been handed a “sense of urgency” at someone else’s expense. I hope they do not waste this rare opportunity to create change that has been handed to them. 

I assume she was referring to O157:H7, but many have taken those words to mean ANY E. coli outbreak. The rationale is that even if the food vector were produce or drinking water, the produce or water probably became contaminated by cow manure containing the E. coli pathogen, a reasonably safe conclusion. The contamination could occur through spreading manure as fertilizer, contaminated irrigation water, pathogens spread by furry animals, etc.

But an interesting report regarding the disaster occurring in Germany was just shared with me by one of the leading E. coli experts in the United States. You can read it yourself here, but I warn you that if your computer does not have the translate function, you will have to read German.

The home page for BfR (Bundesinstitut fur Risikobewertung) says “BfR is responsible in Germany for scientific risk assessments in consumer health protection.”  The home page also states they are heavily involved in the search for the source of the E. coli O104:H4 that is causing such devastation in Europe.

As we have heard before, the report cited above says that the current strain is probably a recombinant of two pathogenic E. coli types, and that “(B)ased on the strain analysis of the serotype O104:H4, BfR believes that it is likely that the transfer of the pathogen to the affected food could have been caused in the current outbreak event via humans or from humans via the environment.”

The BfR goes on to explain why in very scientific language, but in a very simplified version I will try and explain what I have digested from the BfR report.

STECs (Shiga toxin-producing E. coli) hosts are generally ruminants, cows being the most frequently mentioned. After a DNA sequence analysis carried out in a strain associated with the current outbreak, it was determined that the serovar EHEC O104:H4 has more commonalities with the enteroaggregative E. coli (EaggEC) than with the conventional Shiga toxin-forming E. coli (STEC).

The current pathogen in the limelight has 93% similarity with an EaggEC which has already been characterized. The reservoir for EaggEC is human, not ruminant, as far as the current knowledge states, but the report does state very clearly that “only a few EHEC O104 strains have been found all over the world.”

This EaggEC pathogen type has not been detected so far in animals. So, maybe in this case we will not “eventually bump into a cow” but will bump into a human–or two.

Just maybe we are now back to looking at the two workers at the sprouting establishment (rumored to  now be 3) who were sick from the E. coli O104:H4?

Like the familiar cell phone coverage commercial on television, we are beginning to wonder if the President and his appointees at the U.S. Department of Agriculture (USDA) and the Office of Management and Budget (OMB)  are getting any of the many messages being delivered daily about the danger of non-O157 Shiga toxin-producing E. coli (STECs) and the need to declare them adulterants in ground beef.  You would think the enormous, tragic outbreaks of E. coli illnesses caused by serotype O would be hard to miss.

Perhaps messages are getting through to the folks at OMB, but the ones having an impact come from U.S. trading partners.  Some of our partners haven’t had a problem with E. coli O157:H7, but do have evidence of other Shiga toxin-producing E. coli in their food supply.  They aren’t eager to have their exports tested. Those folks clearly have the ear of the U.S. Trade Representative and he, in turn, makes their case to the President.

We know the American Meat Institute, which went to court in 1994 trying to prevent FSIS from treating E. coli O157:H7 as an adulterant, has been to OMB to argue its case against declaring additional strains of E. coli as adulterants.  We don’t know what possible arguments they could make for inaction given recent developments showing these pathogens are both virulent and common in U.S. meat. 

We know, as well, whose advice the White House apparently does not take on food safety and the dangers of Shiga toxin-producing E. coli. The ones without influence would include the USDA’s Under Secretary for Food Safety and the Food Safety and Inspection Service. They are the people responsible for the safety of the meat, poultry and egg products (maybe catfish someday) in the U.S. In January of this year, they asked OMB to approve expanding the per se adulteration designation to several non-O157 STECs.

The list of those not being clearly heard also includes consumer organizations, some of whom went to OMB in April urging them to approve the FSIS proposal. Instead of moving forward, the OMB extended the review period. According to the FSIS staff, the Agency asked OMB to extend the review. That’s usually a sign they thought that was the only alternative to having the proposal rejected outright.

The bottom line is, however, that the USDA’s food safety staff read the literature, examined the data and sought action to reduce the chance of more people getting sick from pathogenic E. coli serotypes in addition to O157:H7.  They have been overruled by more powerful forces and Americans are subject to a greater risk than we should be.

Rulemaking takes at least two years, and usually more when the regulated industry is opposed to the action. If OMB reverses its current position and frees FSIS to move ahead, it will still be months or years before meat coming into the U.S. from other countries will be tested to be sure it is free of the pathogen that recently has caused over 2,000 illnesses in Europe.

By comparison, it only took weeks to get Interim Rules into effect after the U.S. found its first cow that had “Mad Cow Disease,” a necessary move so we could resume exporting beef to our trading partners. No one in the U.S. has ever become ill with variant CJD from eating meat from a U.S. cow.

 It is possible that the FDA will, as part of its rulemaking under the new FDA Food Safety Modernization Act, name E. coli O104:H4 as an adulterant in fresh produce before USDA is freed to require companies to keep it out of our meat supply. As public policy, that’s hard to support. The immediate vector in Europe may be produce but the original pathogenic E. coli was almost surely harbored in the intestine of an animal used for food, most likely a beef animal.

At the time we are writing this, news is coming that the culprit food may be sprouts. If so, they would have likely become contaminated by being exposed to water contaminated with animal waste. But regardless of the vector for this most recent disaster, the current issue on the table of OMB is what to do about these pathogens in our meat.

One month ago, May 2, 2011, to be exact, we joined forces to write an OpEd for Food Safety News trying to bring readers up to date on new developments regarding non-O157 STECs, and debunking some of the most commonly stated reasons for not declaring them adulterants in ground beef.

In the 30-plus days since we penned that opinion piece, we have seen two international outbreaks of epic proportions. 

Japan has nearly 100 ill from the non-O154 STEC known as O111. There are 23 victims with hemolytic uremic syndrome and 4 dead. All from eating beef. And it was steak, not ground beef.

Germany has been the country of origin for over 2,153 illnesses from a non-O157 STEC known as O104:H4, with over 625 cases of HUS and 22 deaths. It is the third largest E. coli outbreak in history, and probably the deadliest.

In our May 2 piece we noted that HUS cases in illnesses from the only banned E, coli, known as O157:H7, are usually in the 8 percent range of all victims. In these two international outbreaks, the HUS rate is near (Japan) or well over (Germany) 25 percent of all victims. For those who have long contended these pathogens are not as virulent as O157:H7 and can therefore be ignored, we say, as we did on May 2, tell that to the families of the deceased or those who will have life-long health issues from their kidney damage.

In these 30 short days, some more information regarding the frequency of non-O157 STECs in (or on) the beef we eat has come to light, helping to squelch another argument against taking any action at this time.

A graduate student at Texas Tech University, Jessie Vipham, working with world famous E. coli expert Dr. Guy Lonergan and others, bought beef and sampled whole muscle cuts and ground beef for E. coli and other pathogens. Her findings showed that 5.9 percent of all beef was contaminated with non-O157 STECs. She found the pathogens in 7 percent of ground beef, and 4.1 percent in whole muscle cuts.

She was looking for what is known as the Big Six, the six most prevalent non-O157s thought to cause human illnesses in the U.S. She found O26, O145, O103 and the afore-mentioned O111 that caused Japan’s outbreak. She did not find O121 or O45, the other two listed in the Big Six, and she did not test for O104:H4. 

The Big Six is important because these are the six pathogens we think FSIS will try to declare as adulterants. That will not help us with any new pathogens that mutate and become killers, like the O104:H4 bug found in so many victims in Germany and from recent travelers to Germany in 11 other countries. The Big Six would be a Big Start, but maybe we need to rethink this in light of the last 30 days of new information and just say any Shiga toxin-producing E. coli should be banned?

The Food and Drug Administration noted last Friday that “the FDA considers any disease causing strain of E. coli in food to be illegal.”

President Obama named Mike Taylor the food safety guru at the FDA. This is the same Mike Taylor who, as Acting Under Secretary for Food Safety, changed the landscape of meat and poultry safety by declaring E. coli O157:H7 to be an adulterant in ground beef in 1994. He did not go through the rule-making process to get there but based his decision on the language of existing law. You need a sense of urgency to create change and Taylor had the Jack in the Box disaster. We now have Germany dwarfing the Jack in the Box for
numbers.

It appears the FDA and Taylor are now ready to treat E. coli serotypes, in addition to O157:H7, as adulterants in FDA-regulated products. Does the Obama Administration apply different scientific standards to the FDA than it does to the FSIS? 

Secretary Vilsack, on the other hand, has publicly dismissed the urgency of expanding protection against other disease-causing E. coli strains.  At a press conference last week he said nothing in his prepared statement about the European E. coli outbreak and made no appeal to USDA to act on the rest of the more common and virulent species of E. coli in the U.S. Responding to a question, he allowed as how he has “no reason to believe what is specifically occurring in Europe is going to happen over here, because of what happened in Europe.”

Perhaps he should have consulted his scientists in FSIS and ARS. They could have told him about  Salmonella enteritidis, the serotype that began in European chickens and eggs, then skipped across the Atlantic and spread across the U.S. to become the most common form of Salmonella food poisoning. Our food system is global. Bugs mutate and travel. We have reason to believe this form of E. coli can, and probably will, happen here.

Robert Tauxe M.D., a foodborne illness expert with the Centers for Disease Control, perhaps put it better when he was quoted as saying: “It’s a wake-up call, around the world.” We hope the President has heard this “call” and the others mentioned above.

The President, his OMB officials, the Secretary of Agriculture and the House Ag Appropriations Committee need to wake up, recognize the danger, and heed the cries of pain emanating from Europe. The infectious disease experts at the CDC are obviously concerned and see the need for action.

We, two former public officials sworn to protect the public against illnesses caused by contaminated meat and poultry, add our appeal to those of the CDC infectious disease experts and the USDA’s current food safety leaders. Please, Mr. President, direct the USDA to declare that any meat product that shows evidence of any disease-causing E. coli organism is adulterated. Require FSIS to sample and test for the presence of these dangerous strains of E. coli.

Can’t we learn from Japan and Germany and act before more illnesses start to turn up in the U.S.?  Politics and trade must take a back seat to preventing serious illnesses and deaths. Go find any infected meat that is out there and get it off the market now. Make sure the  “USDA inspected and approved”  stamp applied to products that meet FSIS’s standards continues to mean someone cares and is acting to protect the public’s health.

Mr. President, can you hear us now?

—————————-

Carol L. Tucker-Foreman was USDA Assistant Secretary for Food and Consumer Services, 1977-81. Her responsibilities included the Food Safety and Inspection Service, the Food and Nutrition Service and elements of the Agricultural Marketing Service.  Richard A. Raymond, M.D., was USDA Undersecretary for Food Safety, 2005-2008.

It’s Time to Move the Needle on non-O157:H7 STECs

The massive 1993 Jack in the Box E. coli O157:H7 foodborne illness outbreak was a seismic event that moved the food safety needle toward greater public health protection. It caused over 650 illnesses and four deaths, introduced the public to the dangers of this previously little-known pathogen, proved foodborne illness was more than “just a stomach ache,” and resulted in the U.S. Department of Agriculture declaring that any amount of the pathogen in ground beef rendered the product adulterated.

E. coli O157:H7 is different from other common foodborne pathogens.  The powerful substance it exudes, called Shiga toxin, causes bloody diarrhea.  As few as 50 bacteria can be infective.  The illnesses  progress to Hemolytic Uremic Syndrome (HUS) in 8 percent of its victims and brings death to too many of our children and other vulnerable individuals.

The USDA’s Food Safety and Inspection Service (FSIS) quickly adjusted to the reality of this new pathogen and, in 1994, issued an interpretive rule  declaring that any amount of E. coli O157:H7 rendered ground beef adulterated.  The rule required that the adulterated product be removed from commerce and be diverted to cooked product or destroyed. The agency also began  testing for E. coli to assure process controls were effective. Industry invested time, money and creativity in the effort to find E. coli O157:H7 and keep it out of ground beef.   Together, industry and FSIS moved the needle toward safer meat.

But our ground beef is still not safe enough.  We now know that other species of E. coli also produce the powerful Shiga toxin, are similar to O157 in virulence, and are much more prevalent than we once thought. These newly emerging pathogens are known, collectively, as non-O157:H7 Shiga-toxin producing E. coli, or non-O157 STECs.  Six of them, O26, O111, O103, O45, O121 and O140, are responsible for foodborne illnesses that have developed into Hemolytic Uremic Syndrome (HUS). These are often referred to as “The Big Six”.

Like E. coli O157:H7 in 1993, the dangers presented by the “Big Six” STEC serotypes aren’t well-known.  Most Americans are completely unaware of them.

The Centers for Disease Control and Prevention (CDC) did not begin analyzing and reporting illnesses caused by the non-O157 serotypes in the Morbidity and Mortality Weekly Report (MMWR) until 2004.  Now that they are reported, it is increasingly clear that the non-O157 STECs contribute to a significant amount of foodborne illness.

The non-O157 STECs may be new and emerging pathogens, but it is also possible that they’ve been out there for years, causing people to get sick and die but were invisible because no scientists or laboratories were  looking for them.

What we do know now is that the CDC’s annual reports on the incidence of foodborne illness in the U.S., published in the Mortality and Morbidity Monthly Report (MMWR), reveal an increase in  non-O157 STEC illnesses in nearly every year from 2000 thru 2007, as follows :

INCREASE IN REPORTED CASES OF NON-O157 STECs (2)

Year   Number of illnesses  Rate of Illnesses per 100,000 population

2000           51                            0.12

2004         106                            0.23

2006         209                            0.46

2007         260                            0.57

The CDC report numbers reflect only the FoodNet catchment areas that represent 15 percent of the U.S. population. The total number of documented cases across the country is larger.  Unfortunately, the CDC estimates that, even now, fewer than 10 percent of laboratories test for these pathogens. As a result, most of the illnesses continue to go unrecognized.  It’s unlikely that the number of cases of non-O157 STECs will decline if there is no organized program to prevent and control them.

After Jack in the Box, we often referred to E. coli O157:H7 as “the rare but virulent” pathogen but once laboratories were required to test for it we found it was not so rare.

Still, many people, including author and attorney Shawn Stevens, have the misconception that non-O157 STEC illnesses are uncommon. He wrote recently in Meatingplace.com that the “other non-O157 strains such as O111 and O145 which, though rare, (emphasis added) can … cause illness” [3]

The evidence shows  these pathogens are far more common and cause more illness than previously recognized.

● The January 2011 CDC report updating data on foodborne illness in the U.S. illustrates that public perceptions lag behind reality.  The annual case rate for E. coli O157:H7 is 63,000 and for Listeria Monocytogenes, it is 1,591.  Both of these are far lower than the so-called rare non-O157 STECS that cause 113,000 cases of foodborne illness each year. [4]

●The most recent CDC FoodNet Report for the year 2009 reveals that, at several of the FoodNet sites, non-O157 STECs are found to cause illnesses more frequently than the declared adulterant E. coli O157:H7. [5]

●The rate of foodborne illnesses caused by non-O157 STECs and O157 is now about the same in children less than 4 years of age, perhaps our most vulnerable population. These are nasty pathogens, not to be taken lightly. And they are not rare.

In 2007, USDA’s Undersecretary for Food Safety was informed that some state public health labs were seeing as many non-O157 STEC infections as they were O157 illnesses. In response, FSIS, along with FDA and CDC, held a day-long information gathering session on the importance of non-O157 STECs and the public’s health. During that meeting, it became clear that two hurdles prevented FSIS from moving forward:  the agency had no solid numbers on the rate of non-O157:H7 STECs contaminating ground beef and  commercially available tests for these pathogens were not yet fully developed.

After this revelation, the FSIS immediately began joint efforts with the USDA’s Agricultural Research Service to speed the development of consistent and convenient testing methodologies for non-O157 STECs. The two agencies recently completed test development and testing kits and protocols are available for all of the Big Six non-O157 STECs.  They were preparing to move the needle toward more public health protection.

Soon aft
er the 2007 meeting, FSIS began testing ground beef for non-O157 contamination, but the agency has not  made the results public.

However,  Dr. Mansour Samadpour of IEH Laboratories and Consulting Group in Seattle reported at the “7th International Symposium on Shiga Toxin Producing E. coli” that his lab tested approximately 5,000 samples of ground beef purchased at retail stores and found non-O157 STECs in 1.9 percent of the samples. One positive out of every 50 packages sampled suggests a high rate of contamination. It is more proof that the pathogens exist in our food supply and make people sick.

The USDA Meat Animal Research Center, located in Clay Center, NE, has also done extensive testing not only for non-O157 STECs in ground beef but also on the relative virulence of the serotypes found.  Their most recent research results, published in March, 2011, can be found at: www.ncbi.nlm.nih.gov/pubmed/21257806.

We expected that, with the completion of the research and development work, the agency would be ready to move quickly to declare these pathogens to be adulterants and to begin testing for them, but there has been no further action.  We were encouraged in our belief by President Obama’s March 14, 2009 speech in which he pledged new attitudes and policies to address weaknesses in the national food safety system. “…there are certain things that we can’t do on our own,” he said. “There are certain things only a government can do. And one of those things is ensuring that the foods we eat, and the medicines we take  are safe and don’t cause us harm.

The FSIS  acted to carry out the President’s pledge. It prepared a rule declaring non-O157 STECs adulterants in ground beef and requiring  testing for them.  We’re confident that the kind of preventive action proposed by FSIS is far better than waiting until  problem with non-O157 STEC foodborne illness reaches seismic proportions, like another Jack in the Box.

The truth is that, if you don’t look for these pathogens, you will not find them until after they’ve already made people sick. The numbers cited earlier indicate at least the potential for another seismic event, a large outbreak and needless illnesses and deaths. The difference now, as compared to 1993, is that we are forewarned.

However, the FSIS’s effort to follow through on the President’s pledge has not been approved by the White House Office of Management and Budget.  It is opposed by the American Meat Institute and some of our trading partners.  In the case of AMI, its position is consistent with its opposition to declaring E. coli O157:H7 an adulterant.  The AMI strongly opposed testing for O157 when it began and now opposes requiring meat companies to test for the “Big Six” non-O157 STECs.

Some foreign countries may be concerned because, while they haven’t found much E. coli O157:H7 in ground beef and trim, they have had occasional findings of  Non-O157 STECs.

We think it is just good sense for anyone who has an interest in promoting the sale and use of ground beef to do everything possible to assure that it is free of pathogens, especially the virulent Shigatoxin producing E. coli serotypes. Anyone who opposes using every tool available to fight these virulent pathogens should try explaining their position of opposition to the parents of a child suffering kidney failure after contracting HUS from one of those strains of E. coli, or to the family of a Korean War veteran who lost their father to the poisoning.

There are real people whose lives have been tragically altered by the presence of virulent pathogens in meat that bears the USDA seal of inspection.  These pathogens are considered adulterants as defined by the Federal Meat Inspection Act. Currently, the U.S. government is not meeting either the letter of the law nor the societal expectation that our food will not make us sick.  We urge the President, his appointees and the industry to join us in supporting FSIS’s efforts to get non-O157 STECs out of our ground beef. 

——————————–

[1] Carol L. Tucker-Foreman was USDA Assistant Secretary for Food and Consumer Services, 1977-81. Her responsibilities included the Food Safety and Inspection Service, the Food and Nutrition Service and elements of the Agricultural Marketing Service.  Richard A. Raymond, M.D., was USDA Undersecretary for Food Safety, 2005-2008.

[2] CDC. 2010. Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food — 10 States, 2009 Report. Mortality and Morbidity Weekly Report (MMWR). Ap 16;59(14) 418-422. 

Accessed at www.cdc.gov/foodnet/reports.htm

[3] April 4, 2011, Meatingplace.com blog Accessed at  www.meatingplace.com/MembersOnly/blog/BlogDetail.aspx?blogID=37

[4] Scallon, et al. 2011. Foodborne Illness acquired in the U.S.–major pathogens. Emerging Infectious Disease

[5] CDC Ibid.

              USDA Announces Proposed Test and Hold Requirement

                              for Meat and Poultry Products

          Will enhance existing procedures, help reduce foodborne illnesses

There has been a lot of press and follow up discussions since that press conference about the need or lack thereof for this new requirement. Much emphasis has also been placed on the possible effect it will have on the very small processors who grind for local customers based on their order for the day. 

In Ms. Bottemiller’s story I was quoted as saying the requirement might be “onerous” for some of the smallest grinders. Doc Mudd tried to take me to task in the discussion following the story, but I will point out right now I did not say whether the required test and hold policy was a good one or not, simply that it might put some very small grinders out of business.

All the numbers you need for a discussion are right here in the Federal Register. These numbers need to come to light for further discussion about the accuracy of the headline that says this “will … help reduce foodborne illness.”

This discussion is especially important if one reads the transcript from the press conference where this proposed new policy was announced. During the Q and A, Secretary Vilsack is quoted as saying “our best estimate is this is going to help prevent 25,000 illnesses.” You can see this for yourself and not have to take my word for it.

If only that were true. If only 25,000 illnesses could be prevented then I might have embraced the AMI petition when they sent it to me as the Undersecretary for Food Safety in June of 2008. If it were true, I would not be worried about one or two very small grinders having to close if they cannot comply with the new test and hold proposal.

But it is not true. A three-year time frame, 2007-2009, was used by the USDA for their statement that 44 recalls happened because product was tested and shipped into commerce before a positive result came back. Of those recalls, 22 were for ground beef with an E coli O157:H7 positive, and 22 were for ready-to-eat products with positives for L. monocytogenes.

Of those 44 recalls, 43 had this statement in the recall notice: “no reports of illnesses associated with consumption of this product.” One recall did have two illnesses associated with it. So the headline that this action will “help reduce foodborne illnesses” is technically correct. But 25,000?

The proposed regulations in the Federal Register, written by FSIS staff, include this statement: “The FSIS model estimated the upper 95% confidence bound of averted E. coli O157:H7 illnesses to be approximately 2.6 for a three year period.”

It goes on to state that the estimated number of L. monocytogenes illnesses that would be averted over the same three year period of time would be 0.18.

These numbers are a long way from the 25,000 stated by the Secretary. That number impressed many in the media and they touted this as a great public health move in the right direction.

Furthermore, FSIS estimates the fiscal savings by avoiding these illnesses would be $7,464 annually, and I seriously question whether that minimal savings warrants the risk of losing some small grinders in rural America. I even question whether an annual savings of 7K warrants the amount of time, energy and money that went into writing the proposed regs in the Federal Register.

And I definitely question whether reducing foodborne illnesses by one case per year, when the CDC estimates there are 63,000 foodborne illnesses per year, warrants a press conference and the media hype.

I think the consensus of the responses I have been seeing echoes these thoughts. Test and hold is a good thing, and the great majority of the grinders already do it. The impact is not going to be a significant reduction of illness, but rather a reduction of negative messages being sent to consumers every time there is a recall. These messages remind them that raw ground beef cannot be considered pathogen free.

The AMI petitioned the Undersecretary back in 2008 because they wanted to improve public relations and all of their members already practiced test and hold, and had been doing so for years. I think another motive for the petition might have been that every time a small grinder needed to do a recall, people like John Munsell were quick to point out that the contamination probably did not occur at the very small grinder, but at the large packing house that they bought ground beef components from.

And the industry as a whole did not embrace mandatory test and hold at that time; the Federal Register points that out very clearly. To say it does now is another inaccuracy.

Looking for total transparency, here are a few more numbers that come from the USDA and FSIS web pages and might shed more light on the true impact of this action.

The total pounds of ground beef recalled as a result of FSIS testing in 2009 were 52,667. Ground beef produced and consumed in the United States, as estimated by the USDA, in 2009 was over 20 billion pounds. The recalled ground beef amounted to 0.00026% of the total produced in 2009.

Total samples tested for ground beef in 2009 amounted to 11,686, of which only 41 were positive, or 0.35% of samples. Of these, 33 were held and then destroyed or cooked and eight, as stated earlier, were out in commerce.

Remember, that is eight lots out of 11,686 lots that we are talking about here.

Lastly, these very small grinders are only subjected to testing for E coli O157:H7 approximately once every three months. That means they can grind and sell product that is not tested every other day of the quarter. How much of that product would test positive?

I don’t know, but I know test and hold is not going to make the ground beef I buy at the local store significantly safer.   

Well, I received a call last week informing me that I was probably wrong on the 64 figure and should check my facts. And it turns out I was wrong, and I hope everyone that read last week’s piece will also be reading this one. I want my stories to be trusted for factual truth, even if not everyone will agree with proposed policies, content, messaging etc.

I use figures to drive home messages, but I do not intentionally alter figures or lie. But for this story I did not double check my figures, and that was my mistake.

The fact is that the number 64 represents positive E coli tests in raw ground beef for all of 2009 and up to November 30 of 2010. I either did not get that information up front, or I may have inadvertently not written it down on my notes. If I would have gone to the Food Safety and Inspection Services’ (FSIS) web page, my error would have been detected. But I did not, so the mea culpa is mine to make.

The numbers for 2010 testing are not yet posted, so I cannot come completely clean and tell you what the total would be for the two years combined, but I can say, with 100 percent accuracy this time, that for 2009 there were only 36 positive test for E coli O157:H7 at the 1,400 federally inspected plants producing raw ground beef. 

To find those 36 positives, FSIS pulled 12,797 samples. The result is 0.30 percent of samples testing positive, compared to 0.44 percent in 2008. And for total transparency today, I feel compelled to add that this testing does not include the small amount of sampling at retail stores, the testing done by state inspection programs and the testing of imported ground beef.

In addition, industry itself tests tens of thousands of samples of trim and ground beef at their own expense, destroying or diverting to cooking all positives not included in the 36. 

Lastly, and surprisingly to me, by going to the FSIS web page on testing results, I saw that for the year to date, thru February 27, there have been 1,775 samples pulled at the federally inspected plants producing raw ground beef and zero samples have tested positive. None, nada, zip, zilch. And that is the best news I have seen in a long time and glad to share it with the readers of Food Safety News.

AMI “believes that it is a misuse of FSIS resources to subject ground beef that has been subjected to FSIS testing at the original production site to be retested by FSIS again, if no other ingredients are added to the ground beef.”

The story was about a simple move by FSIS to collect the names of suppliers at the time bench trim or ground beef was sampled at processing plants. Recent policy was that this information would be gathered only after a sample tested positive, or after an illness was linked to product. But this step appears simple only if you do not know the history.

A similar instruction was issued in 2002, only to be rescinded about three months later for “legal reasons.” I assume “legal reasons” means threatened lawsuits? Some who have been observing FSIS for many years tell me that when HACCP was being debated and discussed back in the 1990s, the issue of tracebacks was one of the major lobbying points. Some felt tracing back to the source just might put packers in a position of “double jeopardy.” I have tried, in vain, to determine if promises were made way back then about tracebacks.

Improvement on traceback efforts by the Food and Drug Administration are being mandated by the Food Safety Modernization Act and improving traceback efforts by FSIS are the subject of bills recently introduced by Senator Tester and Congresswoman DeLauro.

Let me try to explain the public health implications of not tracing back to the source. Left over products from the process of cutting beef into steaks and roasts are called trim. Trim is collected in boxes called combo bins, each usually weighing 2,000 pounds when full. Some trim is tested at the packing establishment for E coli O157:H7, but not all. Trim is often sold to further processors to be used in the production of ground beef and other products, as is boxed beef and other whole cuts, where FSIS may pull another sample of the finished product, ground beef, to test for E coli.

A combo bin may be divided into several components and sold to several processors for grinding. A positive sample at one of these grinders would result in a recall of only that plant’s product if that product had entered commerce, or cooking or destruction if the product was held at the plant. But no action would be taken regarding the other processors’ products made from the same contaminated combo bin products unless an outbreak was involved.

The explanation I received for this flawed policy when serving as the USDA’s Undersecretary for Food Safety was that most ground beef consisted of comingling of product from various sources, and that fact would most often prevent effective traceback.

But I have now learned that in 2010 there were 64 FSIS ground beef samples that tested positive at further processing plants. And of those 64 samples, 29 were from a single source with no comingling of product. None of the 29 positives came from an establishment that did any slaughter, so therefore the contamination had to occur elsewhere. And most, if not all, were very small plants, so they likely would not purchase an entire combo bin of product.

Or maybe they produced their own bench trim from boxed beef. But if that is the case, where did the rest of that contaminated carcass get sent for further processing? And who ate it?

Mr. Goltry says it is a “misuse of FSIS resources” to test product that already tested negative. I say it could help remove contaminated, maybe deadly, product from commerce, thus protecting the public’s health. I believe the statistics revealed in the recently disclosed FSIS data support my thoughts.

I know we can’t test our way to absolute safety in raw meat and poultry, and I support those who say we can’t. That is not my point today.

And I appreciate the millions of dollars industry spends on interventions and testing to protect my health because I love a good hamburger. But let’s look at this issue of retesting from a slightly different angle, going back to my roots as a physician.

Let’s consider that I go in for a physical, and have an electrocardiogram done that is interpreted as negative. A couple of days later I develop crushing chest pain while shoveling snow in 10-below-zero weather. I will not appreciate an American Medical Association or health insurance industry spokesperson saying it would be a “misuse of … resources” to retest again since a previous test was negative.

Decisions are often made using the information at hand. When that information changes, the decisions previously made need to be revisited. When I get chest pain, the normal-appearing EKG needs to be revisited. When a sample tests positive, the decision that was made to place the USDA Mark on the product and place it in commerce needs to be revisited.

I know Scott Goltry. I respect him and I know he does not want contaminated, adulterated product in commerce. I think the AMI that he works for needs to be just a little more open-minded on this issue, and remind themselves of their often-repeated statement that food safety is a non-competitive issue when it comes to protecting the public’s health.

If FSIS does not change its policy of no traceback for a positive ground beef sample, eventually we will have an outbreak that may involve a child’s death from ground beef that was produced at a second establishment that also purchased product from the same combo bin that caused a positive sample at the first grinder. This will be an embarrassment and disaster for FSIS, AMI and the establishments involved, not to mention the victims.

These new numbers have opened a lot of eyes, and we are seeing early action taken toward more effective and efficient traceback to protect the public’s health. The industry can cooperate or they can keep putting out statements that make them appear to be non-caring suits.

If I had a Food Safety Magic Wand … that would be a daunting development, so to make it less daunting and to stay more focused, I am going to assume my Magic Wand is to primarily make our meat and poultry products safer.  I will let the former FDA food safety leaders pen their own cures for what ails the food safety arena that FDA has responsibility for.

But before I focus primarily on the U.S Department of Agriculture’s (USDA) responsibility for meat, poultry and egg products safety, I want to repeat, briefly, what I said in an article for Food Safety News that was posted Jan. 3, 2011, and can be read in its entirety here.

I am going to use my Magic Wand to improve food safety by using its powers to give the USDA and its Food Safety and Inspection Service (FSIS) regulatory authority over all animals and animal products, including all fish and seafood, bison, dairy products and eggs, and to give FDA regulatory authority over all canned and bottled goods, and processed entities like frozen pizzas, sandwiches and flavoring.

The meat in these proposed FDA products has already been inspected and passed.  Adding pepperoni to a pizza that contains spinach, green onions, tomatoes, cheese, pepper and other products that have been linked to foodborne illnesses does not change the public health risk, nor does adding beef to the vegetables in vegetable beef soup increase risk.  But these additions of meat do add cost by now requiring daily inspection of the product. 

The savings produced by moving these very low risk products to the FDA could be used to increase the inspection of animals and animal products, such as eggs and oysters, that are now FDA responsibility and have been linked to foodborne illnesses by daily FSIS inspection.

The very next thing I would use my wand for is to declare whole carcass, low dose, non-penetrating irradiation to be a processing aid, not a food additive.  That done, the industry can now embrace the concept, explore its applications, and over the next few years begin to significantly decrease the pathogen load on carcasses prior to the application of other processing aids down the line, greatly reducing our risks of falling ill from consuming meat.

And, since industry will now have this very important tool to help it produce a safer product, I am now going to declare all non-O157:H7 Shigatoxin producing E coli strains to be adulterants.

At the same time, I am going to take personal risk using the Wand as my protective shield and establish a tolerance level for E coli.  Before you declare me clinically insane, think about the effectiveness of the current “zero tolerance” policy.  It is, at this time at least, unobtainable and non-enforceable.  Develop a realistic tolerance level that is reachable with today’s interventions, and then enforce it.  Allow FSIS to bring action against those few plants that provide the greatest risk to the public with their product.

And speaking of plants that impose a risk, I am also waving my wand at FSIS and mandating that they do trace back to the source of contamination to the very best of their ability.  For example, in the FSIS testing program for 2010, 64 ground beef samples were positive for E coli O157:H7.  Of those positives, 29 were found at plants that used only outside source material and did no slaughter of their own.  And, these 29 plants used only one source in the tested lot.  And that same product from that source was most likely sold to other processors as well.  Yet FSIS maintains that so much ground beef is a blended product from multiple sources that trace back is next to impossible.  Magic Wand, fix this.  Find the source and take action.

We have other products available to assist us in making our products safer, but sometimes the bureaucracy of having three agencies (Animal and Plant Health Inspection Service, FDA and FSIS) with overlapping oversight of these products produces little movement in the approval process, as we saw with the E. coli vaccine.  So I will use the powers of the Wand to declare that Phage treatments are a processing aid, not a food additive, and can therefore be used on primals and trim without labeling restrictions.

Before my Magic Wand’s powers weaken, I want to accelerate the research on the efficacy of the E coli vaccines.  One way I will do this is to provide tax incentives for those companies willing to spend their own resources in this effort.  Heck, I think I will provide tax incentives for any research into more effective ways to produce a safer product.  And then I will wave the wand again, and make FSIS a more cooperative partner with plants looking for new ways to improve safety, and become less of a hindrance to them.

Now that my wand has effectively provided me with the information to declare the E. coli vaccine to be a very effective pre-harvest tool in reducing E coli in beef, I am going to declare the pathogen to be an environmental hazard worthy of the government’s attention to reduce its presence.

Produce is accountable for 34 percent of all E. coli O157:H7 foodborne illnesses, ground beef being responsible for 33 percent, according to Robert Tauxe of the Centers for Disease Control and Prevention.  One-third of E. coli illnesses are not even related to food, but come from our drinking water, recreational water, petting zoos and person-to-person contact.  We need to get it out of the environment to save lives. T hat means reducing it in cattle.  The vaccine will help us get there.

But why should the rancher, feeder or packer bear this expense?  Ultimately it will be the purchaser of beef that pays the price.  So, Magic Wand, make the government develop and pay for a mandatory vaccination program for beef that will save children’s lives, just like they do for most childhood vaccines available now.  The federal government took positive steps to reduce or eliminate Bovine tuberculosis and brucellosis, it should do it for E. coli O157:H7.

It would truly have to be magical, but, when weather permits, washing cattle in the feed lots or on the farms, before loading into trucks and hauling to the holding pens, would effectively reduce the pathogen loads in and around the slaughter facilities.

And the Magic Wand is going to try to find out what truly causes “event days” in beef slaughter facilities so preventive measures can be introduced and implemented by all facilities.  And this just might include changes in facility design to reduce pathogens being introduced by measures other than just the cattle.

I think the Magic Wand, if it has any energy left after taking on the payment method for the E. coli vaccination program, will probably do the same thing for Salmonella vaccines in our poultry flocks.

And then the Wand is going to help me convene a high-level conference on antibiotic use in food animals, and the participants will come willing to listen and to learn, and to stop the non-productive claims that are so often repeated.  There is a middle ground here that can be reached but, if it is not, Co
ngress will come along and
create problems like it did with catfish inspection.

Speaking of Congress, the Magic Wand will give me the power to immediately rescind the actions of Congress that prohibit FSIS from moving forward with risk-based inspection.  This was a budget neutral process that would have increased inspection activities in plants with poor safety records and/or producing high risk products, and would have reduced inspection activities in plants with stellar safety records and plants producing extremely safe products.

The Wand holder feels this will be easier to accomplish now that Congress has mandated in the Food Safety Modernization Act that the FDA use risk as a key element in determining inspection levels and frequency.

While on the subject of high risk products, frozen ground beef patties are a special problem. When cooked in restaurants with validated and documented kill steps, frozen patties are not a problem.  But when cooked at tail gate parties, pool parties, camp grounds, etc, we have a problem.  I might lend the Magic Wand to someone else and let them decide whether to ban the sale of frozen GB patties at retail, or to require that the meat be irradiated with penetrating beams.

And lastly, while the Wand still has some energy left in it and powers to create change, I am going to try and make that final kill step in all homes and restaurants and institutions a reality. My plan will use the same energy and resources that the government used to educate us all about the switch to cable television  and the “dangers” of Y2K  to help the American public understand that raw meat and poultry should not be considered sterile.

As a result of this education effort, the majority of the American public will now know how to safely handle raw meats and poultry and, most importantly, how to measure the internal temperature for doneness.

Actually, this should probably have been the first action taken using the power of the Magic Wand.  It is by far the most important and will have most immediate effect on the safety of meat and poultry products.