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Michael Taylor, FDA’s associate commissioner for foods, gave a major speech yesterday at the George Washington University School of Public Health.

In it, he talked about the origin and effectiveness of HACCP (Hazard Analysis and Critical Control Point) controls for preventing food safety problems.  HACCP, he explained, works just like other aspects of public health practice.  It requires:

• understanding the specific food safety hazards that could affect a particular food production operation,

• devising and implementing scientifically validated controls to minimize the hazards,

• monitoring the implementation of preventive controls to verify effectiveness, and

• making corrections and adjustments as needed, based on experience.

He then went on to say how FDA plans to put the Food Safety Modernization Act into action:

We are well on our way to developing a proposed produce safety rule that addresses areas such as employee hygiene, water quality, soil amendments, and animals in the growing area, as FSMA mandates.

In food facilities, such as processing and packaging plants, we will be proposing rules that are grounded in the widely embraced principles of preventive process control for food safety, similar to HACCP.

The law requires each facility to… (1) evaluate the hazards that could affect food safety, (2) specify what preventive steps, or controls, to put in place to minimize or prevent these hazards, (3) specify how the facility will monitor these controls to ensure they are working, (4) maintain routine records of monitoring, and (5) specify what actions the facility will take to correct problems that arise.

For example, in a facility that produces peanut butter, factors such as  ingredient safety, sanitation, and cross contamination would have to be considered. After the outbreak of Salmonella typhimurium in peanut butter in 2008 and 2009, which caused 714 cases of illness, the company had to reevaluate the hazards in its facilities so this wouldn’t happen again.

Such review and correction – and a sharp focus on specific hazards – will become the norm under a system of preventive controls.

Taylor outlined FDA’s vision for preventive controls from farm to table.  Now, if Congress will just give it the resources to do all this, we might actually have a food safety system that functions.

FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point—the internationally recognized food safety management system—by conducting inspections of foreign seafood processors and importers each year.

These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms.

The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.

• Aquaculture assessments have been limited by FDA’s lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.
• FDA’s sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce.
• FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent.
• In fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues.
• FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.
• FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.

And Congress wants to cut FDA’s resources.  I have no doubt that the FDA could be more efficient but the scope of what it is expected to do with limited resources is beyond absurd.

From where I sit, the entire food safety system needs an overhaul and the problems with food imports are a good reason for doing that.

By this time, you must have heard about the study in Clinical Infectious Diseases sponsored by the Pew Charitable Trusts.  The study found nearly half of supermarket meat and poultry samples to be contaminated with Staphylococcus aureus. Half of the contaminated samples were resistant to multiple antibiotics.

Staph causes awful infections.  When I was a child, my mother had a Staph infection that kept her out of commission for what seemed like months in that pre-antibiotic era.  Antibiotics can keep Staph under control, but not if the Staph are antibiotic-resistant.   Staph resistant to multiple drugs are a clear-and-present danger.  No wonder this study got so much attention.

The study provides strong support for the idea that we ought to be reducing use of antibiotics as growth promoters in farm animals, an idea strongly supported by the CDC.

Even though 80% of U.S. antibiotic use is for farm animals, the meat industry strong opposes any proposal to change its practices.

The National Cattleman’s Beef Association responds by attacking the science:

Calling into question the safety of U.S. beef without conclusive scientific evidence is careless and misleads consumers. Pew Charitable Trusts, an agenda-driven organization on this issue, funded this study, which concludes that its extremely small sample size was ‘insufficient to accurately estimate prevalence rates’ and that ‘public health relevance of this finding is unclear.’ The study’s authors clearly call into question the validity of their own study. The bottom-line is U.S. beef is safe and is part of a healthy, well-balanced diet.

The American Meat Institute reassures the public that meat is safe.  After all, you are going to cook your meat, aren’t you?  In any case, the responsibility rests with you.

While the study claims that the many of the bacteria found were antibiotic resistant, it does note that they are not heat resistant.  These bacteria are destroyed through normal cooking procedures, which may account for the small percentage of foodborne illnesses linked to these bacteria.

As with any raw agricultural product, it is important to follow federal safe handling recommendations included on every meat and poultry package that urge consumers to wash hands and surfaces when handling raw meat and poultry and to separate raw from cooked foods to ensure that food is safe when served.

These sound like the arguments that the meat industry has made for years for Salmonella and E. coli O157:H7.

I see this study as another reason why we need better food safety regulation, and the sooner the better.

Postscript: Bill Marler reports that he had 100 samples of chicken tested from Seattle markets:

IEH Labs found S. aurea [sic], or staph, in 42 percent of the samples overall and Campylobacter in 65 percent. The supermarket chicken was contaminated with other pathogens as well: 19 percent of the samples tested positive for Salmonella, one tested positive for Listeria, and 10 percent showed the presence of the methicillin-resistant S. aureus (MRSA). In an unusual finding, one of the chicken samples tested positive for E. coli 0126, Shiga-toxin producing E. coli (STEC) bacteria more likely to be a contaminant of beef than poultry. Organic Chicken proved to be slightly less contaminated than nonorganic with 7 of the 13 (54%) testing positive for harmful bacteria.

As I said….

My monthly Food Matters column for the San Francisco Chronicle:

Food is cheap at market, but costs a lot elsewhere

Q: I pay a lot for food, and more each day, but then people like you say our food is cheap because its real costs are “externalized.” Huh? What’s that supposed to mean?

A: Food prices are indeed going up, and I can hardly keep track of the possible causes: natural disasters, crop failures, commodity speculation, corn used for biofuels, lack of research in agriculture, the declining value of the U.S. dollar and just plain greed.

But we Americans still pay relatively less for food than anywhere else because so many of the costs of industrialized food production are “externalized.” We pay for them, but not at the grocery store.

Human costs

I was reminded of externalized food costs when reading about the remarkable efforts of a Salinas teacher to educate children of itinerant farmworkers. The kids are trying to learn under disrupted, impoverished, crowded living conditions. If their parents were paid and housed better, we would pay more for food.

Last summer I visited fish canneries at the far end of the Alaskan peninsula. The fish packers were women from the Philippines, working round the clock for months to send money home to their children and families.

The canneries used to hire Alaskan high school students at wages high enough to put them through college. But to keep prices competitive, the companies reduced wages and imported labor. That money disappeared from the community.

The CEO of a large U.S. meat company told me that if he raised wages by $3, he could hire locals and not have to deal with immigrant labor. But then he would have to raise the price of his meat by 3 cents per pound (I’m not kidding). That amount, he claimed, would price him out of competitiveness.

Environmental costs

Twenty billion dollars of our tax money goes to subsidies for industrial food production every year. Additional tax money is required to clean up the mess created by that system – polluted drinking water, infertile soil, ocean dead zones and overall misery in the surrounding areas.

While driving to give a talk at a college in rural Minnesota last year, I passed within a mile or so of an industrial pig farm. The overpowering smell – an externalized cost – was still on my clothes hours later.

Safety costs

Food safety is one casualty of a food system devoted to low cost. Companies save money by cutting corners on oversight and overlooking safety violations. The Centers for Disease Control and Prevention (CDC) says food pathogens cause 48 million illnesses, 128,000 hospitalizations and 3,000 deaths each year.

Some experts say unsafe food costs Americans $152 billion annually – $1,850 for each case in health care and lost wages. Severe illnesses from E. coli O157:H7 can generate more than $1 million in health care costs alone, and ruin lives forever.

To these amounts must be added the costs to food producers of product recalls, continued loss of sales, lawsuits and ruined reputations. Sales of spinach, for example, are only now returning to levels reported before the huge E. coli outbreak in 2006.

Here again, the cost of prevention is minimal for large companies producing large volumes of food. Officials of one vegetable-packing company told me that the impressively comprehensive food safety system they instituted in the wake of recalls raised the cost of their products by only one penny a case (I’m not kidding about this, either).

Despite ample evidence from surveys that consumers are willing to pay more to guarantee safe food, large food producers perceive those few pennies as competitive barriers.

Health care costs

Let’s count obesity as another externalized result of a cheap food system. The cheapest foods are high in calories and low in nutritional value – “junk” foods. When food is cheap, people eat more of it.

Abundant cheap food leads companies to aggressively market their products to be eaten any time, any place and in very large amounts – all of which promote biologically irresistible overeating.

Current estimates of the costs of obesity and its consequent illnesses in health care and lost productivity approach $147 billion annually, almost the same as the cost of unsafe food.

Accurate or not, such numbers provide ample evidence for the need to bring agricultural policy in line with health policy.

To pick just one example: Dietary guidelines say to eat more fruits and vegetables, and cut down on sodas. But the indexed cost of fruits and vegetables has increased by about 40 percent since the early 1980s, whereas that of sodas has decreased by about 20 percent.

The high externalized cost of our present food system is a good reason to reconsider current policies when the Farm Bill comes up for renewal in 2012. Now is the time to start working toward food system policies that will better promote health, safety and human welfare.

Marion Nestle is the author of “Food Politics,” “Safe Food,” “What to Eat” and “Pet Food Politics,” and is a professor in the nutrition, food studies and public health department at New York University. E-mail her at food@sfchronicle.com, and read her previous columns at www.sfgate.com/food.

This article appeared on page H – 4 of the San Francisco Chronicle

Michael Osterholm writes in the current New England Journal of Medicine that despite claims that foodborne illness is declining in the United States, that is only part of the story. His editorial refers to the now-published study of Salmonella Saintpaul that I talked about in a previous post.  He says:

All these findings, however, must be interpreted with caution, since most of the decreases occurred between 1996 and 2000, and there has been little additional change since then.

When the 2009 incidence of infections with the eight primary bacterial and parasitic pathogens is compared with their incidence in the period from 2006 through 2008, no significant change can be seen for six pathogens; only the infection rates with shigella and STEC O157 show significant decreases (see graph).

In addition, recent studies have demonstrated a significant increase in the incidence of foodborne disease caused by emerging non-O157 STEC, suggesting that surveillance for O157 is no longer sufficient to determine the effect of foodborne STEC infections.

On the basis of FoodNet data for the past 14 years,we must conclude that the improvements made in the late 1990s in the safety of our food supply are still having a positive effect. But we’ve made little additional progress in the past decade.

The graph he refers to comes from Pathogen. It represents the percent change in laboratory-confirmed foodborne infections from 2006–2007 to 2009.  The horizontal line represents no change.

Thanks to FoodSafetyNews for the heads up on the latest Government Accountability Office(GAO) attempt to get Congress to consolidate federal food safety functions on one agency.

The GAO’s latest 345-page report on how the federal government can save money lists its proposals in alphabetical order by area.  Agriculture comes first and, therefore, so does food safety.  You have to love the way GAO titles its sections: “Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.”

GAO has been saying this for 20 years.  In 1990, for example, it published reports on who does what in the federal government about food safety and the inconsistencies in oversight.

As I wrote in Safe Food: The Politics of Food Safety (2010),

Today, an inventory of federal food safety activities reveals a system breathtaking in its irrationality: 35 separate laws administered by 12 agencies housed in six cabinet-level departments….

At best, a structure as fragmented as this one would require extraordinary efforts to achieve communication let alone coordination, and more than 50 interagency agreements govern such efforts.

Among the six agencies with the broadest mandates, all conduct inspections and collect and analyze samples, and at least three–though not necessarily the same ones–have something to do with regulating dairy products, eggs and egg products, fruits and vegetables, grains, and meat and poultry.

Until recently, the system had no mission statement (for whatever such statements are worth) and it still does not have consistent rules, clear lines of authority, a rational allocation of resources, or standards against which to measure success.

With such a system, some issues–such as use of animal manure to fertilize food crops—inevitably fall between the cracks and are governed by no rules whatsoever.

Not much has changed in the subsequent 20 years, as this new report attests.  As is inevitably the case, some of the areas of overlap are simply absurd:

The 2008 Farm Bill assigned USDA responsibility for catfish, thus splitting seafood oversight between USDA and FDA. In September 2009, GAO also identified gaps in food safety agencies’ enforcement and collaboration on imported food.

Specifically, the import screening system used by the Department of Homeland Security’s Customs and Border Protection (CBP) does not notify FDA’s or FSIS’s systems when imported food shipments arrive at U.S. ports.

But the worst is the situation with shell eggs, seemingly unfixable, given the 2010 recall of 500 million eggs:

FDA is generally responsible for ensuring that shell eggs, including eggs at farms such as those where the outbreak occurred, are safe, wholesome, and properly labeled and FSIS [USDA] is responsible for the safety of eggs processed into egg products.

In addition, while USDA’s Agricultural Marketing Service sets quality and grade standards for the eggs, such as Grade A, it does not test the eggs for microbes such as Salmonella.

Further, USDA’s Animal and Plant Health Inspection Service helps ensure the health of the young chicks that are supplied to egg farms, but FDA oversees the safety of the feed they eat.

I repeat.  This is not a new issue.  The hope was that the food safety act passed in January would pave the way to establish a single food safety agency.  The GAO report, while urging its creation, doubts that it will cut costs.

But it might save lives.

The New England Journal of Medicine has just published a CDC report bringing the Salmonella Saintpaul outbreak of 2008 to an apologetic close (for a quick rundown on the history of this incident, see my previous posts).

The investigation of this outbreak first implicated tomatoes, with devastating effects on the tomato industry.  As the paper concludes:

Although an epidemiologic association with raw tomatoes was identified early in this investigation, subsequent epidemiologic and microbiologic evidence implicated jalapeño and serrano peppers. This outbreak highlights the importance of preventing raw-produce contamination.

Yes it does.   Jalapeño and serrano peppers turn up in salsas and guacamoles.  These are mixtures of many ingredients that are often eaten with chips or prepared foods.  People have a hard time remembering whether they ate peppers or not, particularly when the peppers are chopped fine.  As the investigators explained:

This outbreak investigation highlights the recurring challenges of epidemiologic identification of ingredients in foods that are commonly consumed, rapid identification and investigation of local clusters, the need to continue exploring hypotheses during an ongoing outbreak, and produce tracing in the supply chain.

Traceback issues such as commingling, repacking, varying degrees of product documentation throughout the supply chain, difficulty in linking incoming with outgoing shipments to the next level in the distribution chain, and the complexity of the distribution chain continue to hinder product-tracing efforts….

In addition, an understanding of the mechanisms and ecologies that can lead to contamination of produce on farms and the institution of additional control measures from the source throughout the supply chain are critical for preventing similar outbreaks in the future.

In other words, we badly need farm-to-table safety controls for all foods, no exceptions.

But, as the accompanying editorial by Michael Osterholm explains,

The new law has a major shortcoming: dollars. There was no appropriation approved by the Congress for the act or authorization in the bill for the FDA to assess fees on the companies that it inspects. The Congressional Budget Office estimated that implementing this legislation would require $1.4 billion between 2011 and 2015….

Recent reports in the media calling this act “historic legislation” must be tempered by the reality that without the necessary resources, requiring the FDA to carry out the law’s required activities will be like trying to get blood out of a rock.

Blood out of a rock?  The House just passed a bill that would CUT the FDA’s food safety budget by $241 million.

Of course the FDA doesn’t need the funds.  After all, only 21% of the 1,500 people known to have gotten sick with Salmonella Saintpaul had to be hospitalized, and only 2 died.  And Salmonella Saintpaul is in foods that real Americans don’t eat anyway, like peppers with funny foreign names and alfalfa sprouts.

I used to say that Congress would never move on food safety until a close relative of a senior Senator became seriously ill with food poisoning.   Now I have to include a senior House member.

Michael Taylor, the FDA’s Deputy Commissioner for Foods, gave a talk in London yesterday at a meeting of the Global Food Safety Initiative (GSFI).

GSFI, for the policy wonks among you, is a project of the Paris-based Consumer Goods Forum (formerly CIES), which brings together CEO-level food industry executives to discuss topics of mutual interest—a World Economic Forum for food companies, as it were.

I’ve given several talks at these meetings over the years, presumably because the organizers like to stir up some controversy once in a while.

Mr. Taylor’s speech, which you can read here in its entirety, does not seem particularly controversial—unless you think that making business responsible for ensuring food safety is controversial:

For those of you who live and work in the European Union countries, imported food is a fact of daily life.

And many emerging economies recognize that food exports can help drive their economic growth.

It is for these reasons – high public expectations and expanding trade in food – that the effort to improve food safety and to build prevention in from farm to table is a global movement…and is good business.

It is a global movement that, very importantly, recognizes that the primary responsibility for prevention rests with business – with those who produce, process, import, and market food.

Consumers certainly have a role to play as food handlers and preparers.

And, of course, government plays a vital role in providing scientific leadership, setting standards for effective prevention of food safety problems, and ensuring through inspection and other means that those standards are understood and met.

But everything we do to improve food safety rests on the foundation of the food industry fulfilling its duty to do everything it reasonably can to make food safe.

FoodSafetyNews has more details on what the meeting was about.   Taylor’s speech is a sign that the FDA is on the job.