Food Safety Recalls: A Tale of Two Agencies

FDA and USDA should learn from each other

On June 17th, ConAgra recalled "... all Marie Callender's brand Cheesy Chicken and Rice frozen meals in commerce..." after the frozen dinners were linked to an outbreak of Salmonella infections. One week later, USDA released a preliminary retail distribution list of recalled products, and has updated the list periodically on several occasions since then. The most recent updated list, released on July 9th, is 56 pages long.

On December 18, 2009, McNeil Consumer Healthcare recalled "... all available product lots of TYLENOL® Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP..." because of an "...unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea." The recall was expanded on January 15th, June 15th, and July 8th to include additional products manufactured at the same facility. McNeil also recalled, on April 30th, an extensive list of children's OTC medications, manufactured at a different location. No formal retail distribution lists have been released for any of these FDA-overseen recalls. Nor will they be.

On the other hand, FDA has released the reports of its inspection of McNeil's Puerto Rico production facility, as well as the Warning Letter issued to the company as a result of that inspection – something that USDA never does.

On the 1st anniversary of the establishment of the Food Safety Working Group, it's time for the Food and Drug Administration and USDA's Food Safety and Inspection Service to compare notes on their recall notification systems and develop a single, comprehensive and open approach to communicating recall and enforcement information to consumers.

Here are a few ideas to get things started:

1. Provide a retail distribution list for all recalls. The list should include food service outlets, restaurants, cafés, and institutional kitchens – not just retail stores.
2. Require retail stores to post a prominent recall notice on the store shelf or refrigerator/freezer where the recalled product is typically displayed. This is already done in some countries, including the United Kingdom.
3. Fine retailers who ignore recall notices and neglect to remove recalled products from sale. This has been done in Australia.
   
4. Post on FDA and USDA web sites in a timely fashion the reports for all inspections during which "significant violations" or "significant deviations" were noted (FDA does this selectively, based on its perception of the public's interest in the results of specific inspections).
5. Post on FDA and USDA web sites in a timely fashion all Warning Letters and other enforcement actions taken (FDA posts Warning Letters, although not always timely).

No recall notification process will ever be perfect. But that doesn't excuse FDA and USDA from striving to achieve a system that gets as much information into the hands of as many consumers as possible as quickly as possible. Let's develop a model that other countries will want to adopt.

And we don't need to pass a new omnibus Food Safety law in order to make it happen.


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"Food" Gets A Mention In State Of The Union Message

I must admit that political speeches tend to put me to sleep.

Last night's State of the Union presentation was no exception. I drifted in and out of consciousness for the duration of the President's address. The only thing that kept me going was the hope that "food safety" would rate a mention.

Alas, it was not to be.

This morning, I accessed the transcript of the speech on the White House web site. Eagerly, I used my Mac Find function to search for any mention of "food" – and found one sentence in which the word appeared.

President Obama said:

"As a result, millions of Americans had more to spend on gas and food and other necessities, all of which helped businesses keep more workers."

If there was ever any doubt of where food safety ranks on this Administration's priority list, that doubt has now been firmly and unequivocally put to rest. Even though we are in the midst of yet another nationwide outbreak of food-borne disease, food safety didn't rate a single, token mention in a speech that was more than 7,400 words long and ran for 1 hour and 9 minutes.

I agree that creating and saving jobs is important. I agree that fixing health care is important. I agree that repairing our broken financial regulatory system is important.

But so is ensuring a safe food supply.

According to the Centers for Disease Control and Prevention, 76 million Americans suffer an episode of food poisoning each year. Five thousand people die as a result; 325,000 are hospitalized. Some of the survivors must struggle with the aftereffects of their illnesses for the rest of their lives.

Unsafe food costs lives, resources, and millions of dollars each and every year. Surely, food safety rates more attention from this Administration.

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Obama Nominates USDA Food Safety Head

Elizabeth Hagen To Lead USDA's Food Safety and Inspection Service

One year after taking office, President Obama has finally named his choice to fill the position of Under Secretary for Food Safety – the senior food safety post within USDA.

Dr. Elizabeth Hagen joined USDA in 2006 and was named to the post of USDA Chief Medical Officer four months ago. Board-certified in infectious diseases, Dr. Hagen both taught and practiced medicine before joining USDA.

Hagen's nomination comes while USDA, FDA, CDC and state agencies are investigating yet another meat-related food-borne disease outbreak – a Salmonella outbreak that has sickened at least 187 people in 39 states. The outbreak, which was linked to ready-to-eat Italian-style cured meats produced by Daniele International, Inc., triggered a recall of 1.24 million pounds of meat last week.

Dr. Hagen wouldn't have been my first choice for this crucial food safety position – I would have preferred someone with more background and training in the relevant sciences. Nevertheless, I am relieved that the President has finally settled on a nominee.

With yesterday's announcement of a discretionary budget freeze, funding of food safety programs within both USDA and FDA will be squeezed. Dr. Hagen and Michael Taylor – the newly named Deputy Commissioner for Foods at FDA – will have to lobby hard, both within the Administration and with Congress, to preserve intact the existing programs in both agencies.

I wish them both well. The safety of our food supply rests in large part on their performance.

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US Food Safety - Rest In Peace

Obama Plans Freeze On "Discretionary Spending"

Targets domestic programs, including Agriculture and Health & Human Services

According to the Wall Street Journal, President Obama is set to announce a three-year spending freeze for all discretionary spending in his State of the Union Address, scheduled for Wednesday, January 27th.

Military, Veterans, International Affairs, Homeland Security, Social Security and Medicare are all exempted from the freeze, which will focus on the remaining 17% of the federal budget. Program areas that likely will be frozen include: Housing and Urban Development, Justice, Energy, Transportation, Agriculture, and Health and Human Services.

So much for Obama's promise last year to increase funding for food safety programs – overseen by the Department of Agriculture and the Food and Drug Administration (part of Health and Human Services).

I Should Have Voted For Hillary!

More than one year after Barack Obama won the presidential election, and nearly ten months after his inauguration, the current administration's efforts to improve our food safety system have stalled. For example:

• We are still waiting to hear who will fill the key post of Undersecretary for Food Safety at USDA.
• Food safety legislation, which passed the House on July 29th, is taking a back seat to health care reform and is unlikely to pass the Senate this year.
• FDA's backbone is as stiff as a strand of spaghetti, as shown by the Agency's cave-in last week over raw oyster safety policy.

President Obama and his "team" have given very little concrete direction to legislators working on food safety reform. His Administration apparently prefers to lead by wishing. The Food Safety Working Group, announced by Obama in March 2009, published its list of food safety principles on July 1st:

• Principle 1: Preventing harm to consumers is our first priority.
• Principle 2: Effective food safety inspections and enforcement depend upon good data and analysis.
• Principle 3: Outbreaks of foodborne illness should be identified quickly and stopped.

This took more than three months to figure out?

The President should have asked Secretary of State Hillary Clinton to join the Food Safety Working Group. She unveiled a detailed food safety policy agenda in February 2008 – one day after Hallmark/Westland Meat Packing Company recalled more than 143 million pounds of beef. Her program included:

• Immediately conduct a thorough audit of our nation's food safety systems to locate weaknesses and gaps.
• Increase USDA food safety funding by more than 50% so that our inspectors have the resources and staffing they need to do their jobs.
• Move toward a single Food Safety Administration responsible for all food products, with strong authorities to protect consumers.
• Give our safety agencies mandatory recall authority and direct them to create a national tracing system so we can determine the origin of tainted food.
• Find, prosecute, and punish food production facilities that abuse animals and allow unsafe food to enter our food supply.
• Ban the slaughter of downed animals.

If Hillary Clinton had won the Democratic Party nomination and the White House, she would not have relied on Congressional committees to draft legislation based on a wish list. Hillary would have sent a detailed draft Food Safety Modernization bill to Congress, and would have lobbied strenuously for its passage. Nor would she have allowed a key food safety position to remain vacant for 10 months.

I definitely should have voted for Hillary!

Cantaloupes, Cows and E. coli O157:H7

October 30, 2009

In the two minutes that it takes to read this article, at least six E. coli O157:H7-infected cows and steers will be slaughtered somewhere in the United States.

That's right. At least three per minute. More than 4,600 per day.

According to USDA statistics, 2.81 million head of cattle were slaughtered during the month of September 2009. If, on average, 5% of the cattle were infected with E. coli O157:H7 – a conservative estimate, based on recent published data – then 140,500 of those 2.81 million cattle were infected with E. coli O157:H7.

Assuming that slaughtering is carried on 24 hours per day, 7 days a week, an E. coli O157:H7-infected cow or steer is slaughtered every 20 seconds.

Is it any wonder that local, regional and national outbreaks of E. coli O157:H7 continue to erupt?

Last month, Guest Blogger Dr. James Marsden propounded his Cantaloupe Theory of meat safety on this site. Dr. Marsden pointed out that trying to control E. coli O157:H7 contamination in ground beef without controlling contamination of the intact animal carcass is akin to focussing on contamination of cut fruit without paying attention to the intact melon.

E. coli O157:H7 is here to stay. We can no longer ignore the simple fact that our current approach to controlling this pathogen in raw meat is not working. In my opinion, Dr. Marsden is on the right track.

We pasteurize milk before it is used to produce yogurts, cheeses, and ice creams. We pasteurize bulk egg before it is used in ready-to-eat foods.

Why don't we require slaughterhouses to pasteurize the surfaces of eviscerated carcasses?

The technology already exists. As Dr. Marsden mentioned, there are several ways to reduce or eliminate bacterial contamination on whole carcasses, including: irradiation, hydrogen peroxide vapor, ozone, or ammonia gas. Other possibilities might include either chemical or enzyme-based antibacterial rinses.

USDA must also encourage the cattle livestock industry to invest in ways of reducing the prevalence of E. coli O157:H7 in beef and dairy herds. Validation and, if appropriate, approval of cattle vaccines against this pathogen should be fast-tracked. In my opinion, if these vaccines reduce the incidence of E. coli O157:H7 significantly, their use should be mandatory.

E. coli O157:H7 has become as much of an issue in cattle as Salmonella has long been in poultry. Unless we change our strategy, the problem will only get worse.

Twenty or more students and chaperones from Lincoln Middle School in Rhode Island were the most recent victims of our failed approach. How many more illnesses and deaths will it take before USDA, cattlemen, and the meat industry adopt a new approach to ensuring a microbiologically safe meat supply?

I call on President Obama and Agriculture Secretary Vilsack to finally name a new Undersecretary of Agriculture for Food Safety, and to charge that person with developing and implementing a new strategy for meat safety.

Has The Senate Sent Food Safety To The Back Of The Bus?

October 4, 2009

We cheered in March when President Obama announced his commitment to reforming the US food safety system.

We applauded in June when the House of Representatives took up H.R. 2749: Food Safety Enhancement Act of 2009.

We saluted in July the Obama Administration's decision to implement a long-awaited set of regulations to address the problem of Salmonella contamination in shell eggs.

We thought we were seeing signs of real progress.

But the Senate – where S.510: FDA Food Safety Modernization Act (the companion legislation to the House bill) was introduced in March – has done nothing except to refer the bill to the Senate Health, Education, Labor, and Pensions Committee.

Yesterday, Michael Moss of the New York Times shared with his readers the story of Stephanie Smith, a dance instructor who was paralyzed as a result of an infection with E. coli O157 – an infection that she acquired by eating a hamburger. One month ago, the Washington Post published a similar story, tracing the travails of Linda Rivera, who almost died after consuming Nestlé raw cookie dough that was contaminated with E. coli O157:H7.

Senate Majority Leader Harry Reid has promised Ms. Rivera's family that the Senate will take up food safety legislation this fall, according to Food Safety News. But that was more than two weeks ago, and there has been no further sign of activity.

The fast action that we saluted earlier this year was prompted by a series of food-borne disease outbreaks and food recalls. Is it going to take another peanut-sized scandal to goad the Senate into action?

Food Safety Working Group Responds

July 29, 2009

I received a personal email letter today from Bruce G. Bundick, Director, Office of the Executive Secretariat, U.S. Department of Agriculture. The content of the letter, reproduced below, speaks for itself.

Dear Ms. Entis:

Thank you for your March 17, 2009, electronic message to the Department of Agriculture (USDA) providing information related to enhancing food safety and offering assistance, in an advisory capacity, to enhance our nation's food safety system. The Food Safety and Inspection Service (FSIS) has been asked to respond.

FSIS is the public health regulatory agency in the USDA responsible for ensuring that meat, poultry, and processed egg products are safe, wholesome, and accurately labeled. FSIS enforces the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, which require federal inspection and regulation of meat, poultry, and processed egg products prepared for distribution in commerce for use as human food.

President Obama has directed USDA and the Department of Health and Human Services (HHS) to develop a plan to improve and modernize the food safety system and ensure that federal agencies' food safety activities are integrated more effectively. As you may be aware, the President's new Food Safety Working Group (FSWG), is chaired by the USDA Secretary, along with the HHS Secretary, and includes other agencies and senior officials who will advise the President on ways to upgrade our food safety laws for the 21st century, foster coordination throughout government, and ensure that the laws that will keep the American people safe are enforced.

You may be interested to know that the FSWG has launched a Web site, www.foodsafetyworkinggroup.gov that allows for continuing comments from the public. We encourage you to use that tool to have a dialogue with the FSWG as the work of the group continues to evolve.

Thank you again for the information that you provided and your interest in enhancing food safety.

Sincerely,

Bruce G. Bundick

Director

Office of the Executive Secretariat

I would like to thank USDA and the Obama Administration for their timely and substantive response to my list of suggestions, which I submitted via the Food Safety Working Group website on March 17, 2009.

Oh Canada!

July 26, 2009

When I worked for Canada's Health Protection Branch ("HPB") in the 1970s, we were blessed with the same type of splintered national food safety regulatory system that the United States still enjoys today.

Agriculture Canada was responsible for meat and poultry. It also handled certification of exports, such as nonfat dry milk. Fisheries and Oceans oversaw fish and seafood. Consumer Affairs monitored labeling issues. Provincial Agriculture or Health departments had exclusive authority over food processors that did not ship products across provincial boundaries.

HPB – nominally responsible for all aspects of food, drug and cosmetics regulation – was not permitted to encroach on other departmental turf, unless invited. Even when another department uncovered a problem, such as Salmonella contamination in nonfat dry milk, HPB had to replicate the Salmonella-positive finding in a fresh set of samples before it could send an inspection team to the processing plant.

I was in charge of the microbiology group that provided lab support to HPB's Québec Region inspection team in 1976, when we learned – to our great delight – that Prime Minister Pierre Elliot Trudeau was planning to consolidate all federal food safety activities under a single department. Although we knew that Eugene Whelan, the Minister of Agriculture, was one of the most powerful cabinet members, my colleagues and I hoped that HPB would be that department.

In an unprecedented move, the Speech From The Throne (the annual unveiling of the government's plans for the coming year) was broadcast live through our building's public address system. All non-essential work halted that morning, as we listened for the short statement that would set the single-agency decision in motion. Imagine our dismay when The Speech ended without any mention of food safety – let alone the establishment of a single agency. At the last moment, Mr. Whelan had managed to torpedo the policy announcement.

Two decades later, the Canadian Food Inspection Agency ("CFIA") was born – and was delivered into the hands of the Minister of Agriculture and Agri-Food. All federal food inspection responsibilities, together with the supporting lab facilities, were transferred to CFIA. Risk assessment research, instead of being consolidated within CFIA, was shipped in the other direction – to Health Canada.

The splintering of responsibility and authority was described in CFIA's first Departmental Performance Report:

"The creation of the CFIA clearly reinforces the division of federal powers between the Minister of Agriculture and Agri-Food and the Minister of Health. The Minister of Agriculture and Agri-Food, through the CFIA, retains responsibility for establishing animal and plant health standards and providing related inspection activities. With regard to food, the CFIA conducts all federal food inspection activities while Health Canada establishes policies and standards relating to the safety and nutritional quality of food sold in Canada. In addition, Health Canada assesses the effectiveness of the Agency’s activities related to food safety."

Canada's single agency solution was the equivalent of turning over all US food inspection authority from FDA to USDA, while transferring all of the research and risk assessment activities to FDA. Responsibility for enforcement of Canada's food safety laws was handed to the same government department that was charged with promoting the country's agricultural and food industry. Instead of creating an independent food safety agency, the Canadian government gave the foxes a larger hen house to supervise.

The split personality inherent in Canada's food safety system was fingered last week as one of the elements that hamstrung the government's response to last year's deadly outbreak of Listeria monocytogenes. According to Sheila Weatherill, appointed by the Prime Minister to investigate the outbreak,

"The lack of a clear understanding about which organization or level of government was responsible for doing what – including which organization should lead the response to the crisis – contributed to the inconsistent management of the outbreak."

The US government is currently reexamining this country's food regulatory system, including the possible establishment of a single food safety agency. Before food safety reform is sent irretrievably down a specific pathway in the United States, members of Congress and the Administration's Food Safety Working Group should study the Canadian experience carefully. A regulatory agency must be free from any conflicting mandates, and must be given all of the research and investigative tools needed to do its job.

As a result of my own experiences while working at HPB in the 1970s, I strongly believe that a single, independent US federal food safety agency would be far preferable to the fragmented system that is currently in place. But it must be done right. Carving up areas of responsibility, authority and resources into bite-size pieces to placate politicians would be a recipe for disaster.

Guest Blog: Bill Marler on Dave Theno

Nearly two months ago, I proposed that Dave Theno – the man who transformed the food safety culture at Jack In The Box after a deadly E. coli O157:H7 outbreak in 1992 – be appointed as USDA's new Undersecretary for the Office of Food Safety. I've never met Dr. Theno, but Bill Marler has. The following Guest Blog by Bill Marler shows clearly why Dr. David Theno would be an excellent addition to the Obama Food Safety Team.

Dave Theno had it right - Secretaries Vilsack and Sebelius should pay attention

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection - Hemolytic Uremic Syndrome. She was only 6 years, 10 months, and 10 days old when she died. Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served at Jack in the Box restaurants on the West Coast during late 1992 and January 1993. Roni Rudolph, Lauren’s mom, I have known for 16 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the outbreak. I too have known Dave for 16 years. However, I only learned recently a significant fact about Dave – one that made me admire him even more – one that I think, not only that all leaders in corporate food safety should emulate, but one that both Secretaries Vilsack and Sebelius should pay attention too.

Dave and I shared the stage at the Nation Meat Association annual convention a few months ago. The NMA is an association representing meat processors, suppliers, and exporters. Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart. However, it was his story about Lauren Rudolph and his relationship with Roni that struck me. Dave told the quiet audience about Lauren’s death. Dave also told us that the death of Lauren and his friendship with Roni had changed him. He told us all that he had carried a picture of Lauren in his brief case everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate. I wonder if Secretaries Vilsack and Sebelius do anything similar when they do their work on President Obama’s Food Safety Working Group? If they do not, perhaps they should?

Secretaries Vilsack and Sebelius right now there are hundreds of families struggling right now due to illnesses and death related to food that you oversee that has been tainted with E. coli O157:H7.

Yesterday, I spent time with a family in South Carolina whose 4 year old ate cookie dough and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications. And, there is a woman in Nevada who is still hospitalized, who has lost a portion of her large intestine, was on dialysis until a few days ago. She faces months if not years of rehabilitation. Both ate cookie dough that was watch over by Secretary Sebelius’s FDA.

Today I sat across the kitchen table with a family who lost their only daughter because she died from an E. coli O157:H7 infection from meat inspected by Secretary Vilsack’s USDA/FSIS. I then visited families in a Cleveland hospital whose children are struggling in their battle against Hemolytic Uremic Syndrome – again E. coli O157:H7 tainted hamburger is to blame.

Secretaries Vilsack and Sebelius you should be like Dave Theno. Run your departments like Dave ran food safety at Jack in the Box. Go meet these families. Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart. It is hard, very hard, but it will give you a real reason to do your jobs.

William D. Marler, Esq.

About Bill Marler: Mr. Marler began litigating foodborne illness cases in 1993, when he represented Brianne Kiner, the most seriously injured survivor of the Jack in the Box E. coli O157:H7 outbreak. He is a committed international advocate for food safety, and has addressed bodies as diverse as the British House of Lords and the Annual China International Food Safety & Quality Conference. Bill Marler comments frequently on food safety issues on Marler Blog.

Transparency 101: A Primer for FDA

July 11, 2009

The new kids on the block in Washington, DC have made much of their intention to promote "transparency and openness in government". It seems, though, that FDA needs some help to figure out what "transparency" and "openness" mean.

transparency: characterized by visibility or accessibility of information especially concerning business practices (from Merriam-Webster Online Dictionary)

openness (derivative of open): completely free from concealment, exposed to general view or knowledge (from Merriam-Webster Online Dictionary)

For example, openness and transparency mean:

• Releasing the entire inspection report for Nestlé's Toll House cookie dough production facility, not just a one-page summary for an investigation that took two weeks to carry out
• Releasing the results of lab tests, including the genetic fingerprints of the strains of E. coli that were found in the cookie dough
• Explaining what additional steps FDA and Nestlé have taken – or plan to take – to find the source of the contamination (such as investigating all of suppliers of ingredients for Toll House cookie dough)
• Describing how Nestlé plans to change its procedures or processes in order to prevent a repeat of their contamination problem
• Releasing a full list of retail consignees of the recalled Toll House cookie dough (as USDA does for meat recalls) rather than relying solely on individual retailers to inform their customers of the recall

According to the one-page summary report released by FDA, inspectors found only two relatively minor deficiencies in the Toll House production plant during their two-week investigation. Yet raw cookie dough that was manufactured in that facility contained enough E. coli O157:H7 contamination to sicken 74 people in 32 states, and send 34 of the victims to hospital. Furthermore, the strain of E. coli o157:H7 that FDA recovered from a sample of cookie dough as part of its investigation did not match the outbreak strain found in all 74 outbreak victims, and a third E. coli strain (not O157:H7) was recovered from a sample of raw cookie dough obtained from an outbreak victim.

This doesn't add up. Multiple strains suggest either a recurring source of contamination – perhaps from a particular ingredient supplier – or a long-standing build-up of contaminants over time. What have Nestlé and FDA missed? What leads are they still following up? Or has the plug been pulled on this investigation? We won't know unless and until more information is released.

Consumers have the right to know what is being done to protect the safety of their food supply. But until FDA figures out how to follow through on this Administration's promise to provide the public with complete and timely information, "transparency" and "openness" will remain nothing more than words in the Merriam-Webster dictionary.

Food Safety Working Group: The First Fruits

July 7, 2009

Today's live briefing by Vice-President Biden, Health & Human Services Secretary Sibelius, and Agriculture Secretary Vilsack has revealed the extent of the Obama Administration's commitment to addressing the complex issue of food safety.

The Food Safety Working Group ("FSWG") – launched on March 14, 2009 – has made more progress on food safety in the last four months than the Bush Administration did in its last four years. The Key Findings document released by FSWG contains a "To Do" list of more than a dozen priority projects, including at least one shovel-ready program – Reducing Salmonella In Eggs.

On September 22, 2004 – nearly five years ago – FDA proposed a new regulation to address the presence of Salmonella Enteritidis ("SE") in intact shell eggs. The agency held three public meetings, and opened its proposed regulation to extensive comment periods. The final comment period closed four years ago, on July 25, 2005.

Today, FDA announced that it was, at last, moving ahead with this new regulation. The Final Rule, which will appear in the Federal Register, takes effect 60 days after publication and sets out requirements that most egg producers will have to follow (small producers will be exempt).

These new mandates – some of them already being followed on a voluntary basis – include,

• Developing and implementing a written SE prevention plan;
• Pullets (young hens that will be used as layers) are to be raised in an environment that is monitored for SE;
• Establishing an environmental control program to prevent cross-contamination between henhouses and farms;
• Using rodent and pest control programs;
• Cleaning and disinfecting henhouses after SE contamination is detected;
• Mandatory environmental testing for SE at specified stages during the life of a laying flock;
• Mandatory egg testing for SE when an environmental sample is SE-positive;
• Maintenance of appropriate records; and
• Registration with FDA.

Egg producers that maintain flocks of 50,000 or more hens must comply with this new regulation by July 9, 2010; smaller producers (with 3,000 - 50,000 hens) have an additional two years to bring their operations into compliance. Very small producers – those with 3,000 or fewer hens – are exempt from the provisions of this Final Rule.

The Food Safety Working Group announced ambitious targets for some of its other priority items, too:

• USDA will develop new standards to reduce Salmonella in poultry by the end of this year, and will work to have 90% industry compliance with the new standards by the end of 2010;
• FDA will issue draft guidance on preventing pathogen contamination on leafy green produce, melons and tomatoes by the end of this month;
• FDA and USDA will work with industry and state governments this year to build a national trackback system that will speed up the process of tracing the source of foodborne illness outbreaks;
• Government will begin, within 90 days, to enhance the www.foodsafety.gov website and introduce an individual alert system in order to deliver recall and alert messages into the hands of consumers more rapidly; and
• FDA will create a new position of Deputy Commissioner for Foods by the end of this month.

So far, the Administration's approach is garnering support from both industry and consumer advocacy groups. "Today's recommendations by the White House Food Safety Working Group," said Grocery Manufacturers Association President & CEO Pamela Bailey in a statement released today, "are another example of President Obama's commitment to strengthening and modernizing our nation's food safety system."

Tom Stenzel, president and CEO of the industry group United Fresh Produce Association, said in a written communiqué, "The administration's plan embraces several key recommendations advanced by United Fresh to help ensure that food safety initiatives address produce industry priorities." And Jim O'Hara, Director of the Produce Safety Project – a food safety advocacy group based at Georgetown University – released the following statement:

"The Obama administration's commitment today to a produce safety rule is a significant public health victory for American families and farmers. Fresh fruits and vegetables are critical to a healthy lifestyle. With this rule consumers can have greater confidence in their fresh fruits and vegetables and growers and producers will have a uniform and science based road map on safety standards."

If today's activities are an indicator of future performance, we should be seeing a lot more action within the next 3-6 months. And President Obama's team might even fulfill his predecessor's empty boast that the United States has the world's safest food supply.

Is The US Finally On The Road To Food Safety Reform?

June 5, 2009

The draft Food Safety Enhancement Act of 2009 lists a backlog of regulatory reforms that have accumulated in the desk drawers of Congressional legislators for a decade or more. And, with the backing of the Obama Administration, it has a good chance of becoming law.

The proposed Act provides for several key changes to the way the United States approaches food safety. What do some of these changes mean for the food industry and for consumers?

Mandatory Recall Authority

We, along with many others, have been advocating this change for a very long time. It will allow FDA to initiate a recall in those cases where a food company refuses the agency's request for a voluntary recall. The new authority will rarely need to be used. It's mere existence will be a stimulus to industry cooperation.

Universal HACCP

HACCP (Hazard Analysis and Critical Control Points) is a preventative approach to the production and processing of safe food. The meat and poultry industry adopted HACCP a decade ago at the insistence of USDA. FDA already requires some food industry sectors – seafood processors, for example – to operate under HACCP. Now, if the proposed bill becomes law, HACCP will be extended to the entire food industry. The program would be phased in, first in large companies – many of which already follow HACCP practices – then in smaller ones.

Annual Registration of All Food Operations, Including Warehouses, Food Brokers and Importers

The 2008/2009 Peanut Corporation of America fiasco was complicated by the apparent invisibility of the company's Texas facility. Although registered with FDA, the facility was not known to the Texas Department of State Health Services. As a result, it never was inspected by the State (which was operating under contract with FDA) until after the federal agency followed the evidence trail from Georgia to Texas. Annual registration may reduce the risk of this problem occurring again, but only if there is effective sharing of the registration information between FDA and state agencies. The $1,000 annual registration fee that is part of this mandate should help to defray the costs of information sharing.

Country of Origin Labeling

This already is a requirement for some foods (just check the labels on your supermarket fruits and veggies). If the proposed bill becomes law, all foods would need to be labeled with their country of origin. This is not, strictly speaking, a food safety issue – unless a food product or ingredient from a specific country has been fingered as the source of a problem (e.g., melamine adulteration). But many consumers want to be able to choose which countries they will support with their food dollars.

Reinspection and Recall Fees

Until now, FDA has been forced to swallow the entire cost of overseeing food safety recalls and of follow-up inspections needed to determine whether a food facility has corrected deficiencies noted during routine inspections. The proposed legislation will shift FDA's reinspection costs to the out-of-compliance facilities. And the extraordinary costs to FDA associated with product recalls also will be borne by the companies whose products have been recalled. Companies that cut corners on food safety will now risk paying a higher price for their mistakes. The Grocery Manufacturers Association has – not surprisingly – expressed its displeasure over what it described as an open-ended fee.

Whistleblower Protection

The draft bill offers protection to company employees who witness and report infractions or conditions at the workplace that might render a food product unsafe. The provision would prevent an employer from discriminating or retaliating against a whistleblower.

There is a lot more – 116 pages of draft legislation in all. Many of the provisions are long overdue. Many will be expensive to implement.

On June 3rd, the House of Representatives Sub-Committee on Health held an initial hearing on the draft bill. Witnesses included government, industry and consumer representatives. The last to testify was newly confirmed FDA Commissioner Margaret Hamburg.

After the hearing, Commissioner Hamburg was asked by reporters what she learned in her first Congressional appearance as FDA Commissioner. She replied, "That I have a lot to learn."

If passed, rapid and effective implementation of this monumental revamping of food safety laws will depend on Margaret Hamburg being a fast learner.

The Next Food Safety Czar: A Modest Proposal

May 21, 2009

One of Tom Vilsack’s first acts after being confirmed as Secretary of Agriculture was to name Ronald F. Hicks as Acting Deputy Undersecretary for Food Safety. In his memo announcing the appointment, Secretary Vilsack said of Mr. Hicks that his “… extensive experience will bring great benefit to the Agency as this administration shapes its vision for a productive transition.”

And what, exactly, does Ron Hicks bring to the food safety table? An academic background in veterinary science? In microbiology? In anything biological? Or, maybe, expertise in developing and implementing food safety programs – anywhere?

Not a chance! Ronald Hicks is an attorney by training and an administrator by temperament.  His previous position was Chief Operating Officer of FSIS, with emphasis on the “…design, operations and improvement of FSIS management systems.”  In short, Ron Hicks is a desk jockey with a law degree.

Hicks’ immediate boss was Elizabeth Johnson, the Acting Undersecretary for the Office of Food Safety (She left in December 2008). Johnson worked as a research dietitian within USDA, a nutritionist within the food labeling division of FDA, and as a consultant to government and the private sector on nutrition, farm credit and livestock issues. Food safety was not in her resumé.

Reporting to Hicks is Alfred Almanza, the present FSIS Administrator. Almanza began his career as an inspector with USDA 30 years ago, and has risen through the ranks. He is the only member of the senior USDA team who has direct training and experience in food safety issues.

Secretary Vilsack badly needs a senior team member with the knowledge and experience to guide USDA’s efforts to revamp food safety policies and enforcement. We have found the perfect candidate.

Dr. David Theno has all the necessary qualifications for the position of Undersecretary for the Office of Food Safety. After earning his degrees in animal sciences, he worked for large food companies, such as Armour Foods and Foster Farms. He has led his own independent consulting firm. In 1993, following a disastrous outbreak of E. coli O157:H7, Jack-In-The-Box recruited Dr. Theno to reinvent that organization’s tattered food safety program.

The program developed and implemented by David Theno earned awards both for the company and for him. Last year, Dr. Theno retired from Foodmaker (the parent of Jack-In-The-Box), and is now an independent consultant once again. 

Dr. Theno knows the meat industry, knows food safety, and knows how to get things done. Tom Vilsack needs him at the pinnacle of the food safety pyramid.

David Theno has the right stuff!

Who's Minding The [Food Safety] Store?

May 19, 2009

Yesterday, the Senate confirmed the appointment of Margaret Hamburg as the new FDA Commissioner. She joins HHS Secretary Kathleen Sibelius and Agriculture Secretary Tom Vilsack at the top of the US Food Safety triumvirate. 

Dr. David Acheson and Dr. Stephen Sundlof – holdovers from the Bush Administration – continue to fill supporting roles as FDA Associate Commissioner for Food, and Director of the Center for Food Safety and Applied Nutrition, respectively.

As usual, food safety is “tail-end Charlie” at USDA. The current FSIS Administrator, Alfred Almanza, is a holdover from the previous Administration. President Obama has yet to nominate a new Administrator for this most senior food safety position at USDA. Meanwhile, the positions of Undersecretary and Deputy Undersecretary of Agriculture for Food Safety also continue unfilled.

Vilsack, Sibelius and Hamburg most likely will guide US food safety policy for the remainder of President Obama’s first term. What do we know about them, and what do their appointments tell us about the President’s true commitment to revamping the US food safety infrastructure?

Secretary Tom Vilsack (Agriculture): Former Governor of Iowa. Secretary Vilsack was a supporter of biodiesel and ethanol production, health care reform and education reform during his tenure as Governor. He also led agricultural trade missions, promoting sales of his state’s agricultural products. The Secretary’s official biography makes no mention of his stance on food safety.

Secretary Kathleen Sibelius (Health and Human Services): Former Governor of Kansas; former Kansas Insurance Commissioner. The Secretary’s official biography does not even mention food safety. In her written testimony, submitted during her confirmation hearing, she stated, “… health reform would be my mission …”

FDA Commissioner Margaret “Peggy” Hamburg: Former Assistant Health Secretary in the Clinton Administration; Former New York City Health Commissioner. Dr. Hamburg is described as an expert in bio-terrorism. 

Secretaries Vilsack and Sibelius both were strong supporters of President Obama during his nomination campaign. Their appointments are highly political. Neither they, nor FDA Commissioner Hamburg, can claim any significant background or record regarding food safety. These are the people who now lead the President’s new Food Safety Working Group. 

The American consumer deserves – and should demand – the appointment of a Cabinet Secretary whose primary mission is food safety. This crucial public health sector must not continue to be a political football.

Food Safety Working Group: Stop The Insanity!

April 3, 2009

Insanity: doing the same thing over and over again and expecting different results.

- Albert Einstein

FDA and the California Department of Public Health held a teleconference for accredited journalists on March 30th to brief the media on the Setton Pistachio recall situation. The tone of this teleconference – a transcript is available on the FDA web site – was upbeat; the system was working properly, Setton and Kraft acted responsibly, FDA and California were ahead of the curve.

Since then, additional information has been released that is not as reassuring. According to Associated Press, FDA's investigations have expanded to include Setton's Commack, NY production facility, which uses pistachios from the Terra Bella (California) plant in its chocolate-covered and yogurt-covered nuts and dried fruit products. The New York State Department of Agriculture & Markets is assisting in that investigation.

More worrisome was the revelation reported by Elizabeth Weise of USA Today that Setton Pistachio's own lab tests had revealed a Salmonella contamination problem for several months before Kraft Foods blew the whistle on the situation. And Setton used the same machinery to handle both raw and roasted pistachios.   

While FDA believes that the Salmonella-positive pistachios were destroyed rather than distributed, a Setton spokesperson was unable to confirm the destruction when asked.

During its investigation of Peanut Corporation of America, FDA discovered that the company's Texas production facility had never registered with the Texas Department of State Health Services, and had never been inspected prior to the Salmonella outbreak investigation. Today, the Washington Post reported that FDA identified 20 previously unknown and unregistered peanut facilities as part of the PCA outbreak/recall activities. The agency is not releasing the names or locations of those unregistered facilities, but indicated that these 20 facilities would be visited "shortly".

The demands on FDA's inspection and lab resources during the peanut Salmonella outbreak were overwhelming. And the pistachio investigation has followed hard on the heels of the peanut outbreak. FDA is desperately in need of more trained inspectors, more experienced lab personnel, and more funding. And a better statutory framework for its programs.

If ever there was doubt about the urgency of the need to revamp the US regulatory approach to our food safety system, today's news should squelch any desire for foot-dragging on the part of the Obama Administration, Congress, and the Food Safety Working Group.

Those who don't know history are destined to repeat it.

- Edmund Burke

Food Safety Working Group: Modest Proposal #3 - UPDATE

Updated March 23, 2009

Original article posted March 21, 2009

The food safety system now in force in the United States is based on Voluntary Compliance. One question that the President Obama's new Food Safety Working Group must address is how well this approach is working – or whether it is working at all.

Voluntary Compliance is a widespread government tool. The Internal Revenue Service uses it to collect income taxes. Cities and states use it to control vehicle speeds and limit impaired driving. And USDA and FDA use it to procure industry compliance with food safety laws and regulations.

Central to the success of Voluntary Compliance is the existence of significant consequences to non-compliance. IRS imposes financial penalties for late payment or non-payment of income taxes. Drivers who exceed a speed limit risk fines – often adjusted to the magnitude of the speeding offense. Impaired drivers may have their licenses suspended, or even face a jail sentence.

What, then, are the consequences that confront a food processor who contravenes a federal or state food safety regulation?

The most likely consequence is that the processor will be asked to recall one or more production batches. If the processor agrees, the only consequence is the cost of the recall – including lost sales, returned product and temporary loss of consumer confidence. If the processor demurs, there is no recall – unless the situation is so dire that the FDA or USDA is prepared to go to court to seek a recall order. By this time, of course, the recall is often moot. Most of the recalled food will already have been consumed.

Consider, by comparison, the recent situation in Texas. The Texas Department of State Health Services (DSHS), on February 12th, ordered – that's right, ordered – Peanut Corporation of America to recall "... all products ever shipped from its Plainview plant." When Texas did not receive a response from the company, the state stepped in and took over the recall on February 20th. 

Texas law gives the State's health department mandatory recall authority – the power to demand a recall – when it believes that a situation presents "... an immediate and serious threat to human life or health." And the State can, in the absence of cooperation from the food company, step in and take over the recall. 

FDA does not have this power. Neither does USDA. 

These two federal agencies, responsible for ensuring the safety of all foods shipped interstate or imported into the United States, have less recall clout than the state of Texas and several other US state agencies.

Other countries have equipped their national food safety enforcement agencies with mandatory recall authority. The Canadian Food Inspection Agency has this tool in its enforcement arsenal. So does Food Standards Australia New Zealand. This tool is rarely used. Its mere existence is enough to ensure industry cooperation with a recall request.

For several years, members of Congress and food safety advocates have been urging the adoption of mandatory recall authority. The Food Safety Working Group should include this useful tool in its list of recommendations to President Obama. 

Voluntary Compliance works best when the risk of non-compliance outweighs the reward.

March 23, 2009 Update

In a further illustration of the need for mandatory recall authority at the federal level, FDA today warned consumers against eating peanuts and peanut products sold by Westco Fruit and Nuts Inc. This warning was issued after the company declined to issue a voluntary recall of products that contained peanuts supplied by the Blakely, GA facility of Peanut Corporation of America.

Food Safety Working Group: Modest Proposal #2

March 19, 2009

Two of the biggest food safety stories in 2008 concerned imported products – melamine-adulterated milk from China and Salmonella-contaminated Mexican peppers. 

These incidents shone an intense, albeit brief, spotlight on some of the gaps in our surveillance of imported food products. Inevitably, one of the priorities of the Food Safety Working Group will be to recommend improvements to bolster our protection against contaminated imports.

The existing FDA Import Program is in a state of chaos. We heard reports last year of inadequate computer systems for screening import data, and an overloaded staff that was unable to cope with the volume of imports. FDA's Import Program System Information web page, intended to provide readers with an overview of the system, is incomplete and under revision. 

Fortunately, there are some ready-made import program models that the Working Group can examine in preparing its recommendations for revamping the US Food Import Safety Program. One of these is Canada's. The other is the system used by Australia and New Zealand.

Food Standards Australia and New Zealand (FSANZ) has defined two categories – "risk" and "surveillance" –  for imported foods, and directs its surveillance activities accordingly. 

The surveillance category includes foods that are considered to be of low risk. These imports are subjected to a random selection for testing. Five percent of low risk import shipments are inspected at the port of entry and sampled for lab analysis, if appropriate, under a "test and release" program.

"Risk" category imports face a much more stringent "test and hold" entry barrier, as the following description from the Australian Quarantine and Inspection Service explains.

The Australian Customs Service refers 100% of risk category foods to AQIS for inspection and testing against a published list of potential hazards determined by FSANZ.

Risk category foods are initially inspected and tested at a rate of 100%. Once five consecutive consignments have passed inspection, the rate is reduced to 25%; after a further 20 consecutive passes, the rate is further reduced to 5%. Regardless of the manufacturer’s history of compliance, any consignments that fail will increase the rate of inspection and testing until a history of compliance is re-established.

The FSANZ program is supplier-based as well as country-based. It's not enough for consecutive consignments from a specific exporting country to pass these compliance criteria. Each individual exporting company must develop and maintain its own compliance history.

This approach to import screening has the great advantage of putting the onus directly onto the shoulders of each individual supplier to demonstrate the safety of its products. Conversely, a single "bad actor" from one country does not adversely impact the export capabilities of other suppliers from that country. 

One could argue that the sheer number of food consignments entering the United States every day would make a system such as Australia's too expensive and unwieldy for US purposes. But there are ways to make this work. We could, for example,

• Charge a user fee that would cover the cost of inspection and testing;
  
• Offer importers the option of an accelerated clearance if they pre-clear their shipments using a government-accredited lab; 
  
• Develop an importer-accessible computer database system that would allow the accredited labs to submit their reports directly to FDA; and
  
• Develop AND ENFORCE policies and rules that prevent an importer from "lab shopping".
  

No system of import surveillance can guarantee safety. But a functioning risk-based system that places the burden of proof where it belongs – on the shoulders of the manufacturers and importers – can limit the entry of contaminated food or beverages from outside the United States into the domestic food supply.

Food Safety Working Group: Modest Proposal #1

March 17, 2009

Certain food borne diseases are "reportable" illnesses; that is, a lab diagnosis of the illness must be reported by medical practitioners to health authorities. In 1998, CDC inaugurated a system known as PulseNet, which receives information, including genetic fingerprints, on all of the reported cases in the United States. Since its inception, PulseNet has gone international, sharing data and genetic fingerprints cooperatively with many countries around the world. 

US outbreaks of food borne diseases – Salmonella, Listeria monocytogenes, E. coli O157:H7, Campylobacter, and Shigella – are recognized when CDC spots one or more clusters of cases that have a common genetic fingerprint. CDC then works with health investigators in the affected states to determine whether an outbreak is underway and to find its source.

If the source of the outbreak appears to be a food that is regulated by the FDA, that agency is called in. Likewise, the USDA becomes involved if the suspect product is regulated by that department. State departments of health and agriculture in those states where outbreak cases have been detected also participate in the investigation.

There are several points at which this multi-layered system for spotting outbreaks can bog down.

• Food poisoning victims often do not seek medical attention. Most mild cases of illness never are reported.
  
• Doctors do not always ask their patients to provide stool samples for lab analysis. Without lab analysis, cases go unreported.
  
• Not all states are equally well equipped with facilities for genetic fingerprinting of pathogens. Clinical labs in these states may have to ship their cultures to another state for fingerprinting, causing reporting delays.
  
• There may be delays in reporting information to PulseNet.
  
• Overburdened staff at CDC (and its international partners) may not spot connections between individual cases from different geographic locations, until an outbreak has produced several illnesses from a single location.
  

Certain of these bottlenecks are difficult to remove. Someone with a mild case of gastroenteritis is unlikely to visit a doctor or clinic just to satisfy the needs of a national health surveillance system. But we would like to propose a couple of suggestions that might make a difference

1. Determine which states lack adequate facilities for carrying out full genetic fingerprint analysis of food borne pathogens, and provide federal funds to equip, staff, train, and maintain one such facility in each of these states. 
   
2. Review the procedures for submitting information to PulseNet and make any necessary adjustments so that the process is as simple and user-friendly as possible.
   
3. Share real-time access to PulseNet data with the food safety community outside of government agencies.
   

Data sharing would allow outside parties to help spot incipient outbreaks and flag them to CDC for more careful screening. Some college professors might use PulseNet as a teaching aid, or assign class projects based on the data base. And microbiology-savvy bloggers – including yours truly – could monitor PulseNet on a regular basis, supplementing the resources available for detecting outbreaks, without any additional cost to the CDC. 

In this age of instant information access, it would be wise for the Food Safety Working Group and CDC to examine ways to take advantage of outside expertise to supplement internal resources.

Food Safety Working Group: Recommended Reading

March 16, 2009

In order to achieve an effective, efficient food safety regulatory system – one that assures a safe food supply at a cost we can afford – the new Food Safety Working Group will need to do its homework.

Specifically, we would expect this interdepartmental committee to:

• Define the scope of the problem;
  
• Study past efforts taken to revamp the US food safety system;
  
• Study efforts made by other countries to reform their food safety systems; and
  
• Determine what worked – and what fell short – in past reform efforts, both domestic and international.
  

As a first step in this review process, we would suggest a Required Reading list for Working Group members that includes at least the following items:

• The Food Safety Strategic Plan issued by the President's Council on Food Safety, issued January 19, 2001 and shelved on President Bush's watch;
  
• The transcript of the February 11, 2009 House Subcommittee on Oversight and Investigations on The Salmonella Outbreak: The Continued Failure to Protect the Food Supply and associated documents;
  
• Ensuring Safe Food: From Production to Consumption, National Academy Press, 1998;
  
• US Government Accountability Office reports on food safety issues, including Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness, issued in June 2008;
  
• USDA Office of Inspector General Reports;
  
• H.R. 875: Food Safety Modernization Act of 2009; and, in a reminder that those who don't learn from history are bound to repeat it,
• Food Safety: Old Habits, New Perspectives, ASM Press, January 2007

Much of the leg work has already been carried out, especially by the President's Council on Food Safety. While some of the Council's observations and recommendations will need to be updated, most of its findings are still current. 

It should not take another seven years – and several more major outbreaks – before the Working Group submits its recommendations to President Obama for action.