Currently browsing posts about: Food-safety

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.

Michael Taylor, deputy commissioner for food at FDA and long a proponent of food safey, gave a speech on January 27 outlining the FDA’s plans for implementing the new food safety law.

He pointed out that the new law says:

• Food producers and processors must institute preventive controls.
• FDA has new legal powers to ensure that they do.
• FDA can focus efforts on riskiest foods.
• Food importers must meet accountability requirements.

Taylor got right to the point:

So, let me give you a sense of what you can expect from FDA.

First, we’ll hit the ground running…So we embark on implementation with considerable momentum.  

Second, the vast workload that comes with the new law – over 50 new regulations, guidances, programs and reports to Congress – means we have to set priorities for our work…you can expect timely completion of the rulemakings required to set standards for produce safety, preventive controls, and intentional adulteration…And you can count on us giving high priority to building the new import oversight system.

Third, we are absolutely committed to full, transparent engagement with all stakeholders – industry, consumers, public health experts, and other government colleagues – to take advantage of their expertise and diverse perspectives.   

Finally, you can count on FDA to maintain its strong commitment to public health and to achieving the new law’s public health goal in a manner that is in keeping with the consensus that gave rise to the legislation. 

As for the vexing question of how the beleaguered FDA is going to be able to pay for all this?

And, in a world of finite resources, we’ll change how we work to make the best use of every resource we have…Make no mistake, resources will be a continuing issue as we work to build the new food safety system. 

As I hope I’ve made clear there is a lot FDA can and will do to put the new law into action and build the foundation for a new system, but completing the system – fulfilling the Congressional vision embedded in the new law – will require new resources and investment.  

We look forward to working on this issue with our colleagues in industry and the consumer community, and with leaders in Congress. 

Well, good luck with that last one. Members of agricultural appropriations committees have already threatened no new resources for FDA.

Recall: FDA, an agency of the public health service (like NIH or CDC), gets its funding from agricultural appropriations committees—not health committees.  Nobody talks about this bizarre historical anomaly very much but I see it as a huge problem for FDA and one that badly needs fixing.

The fix isn’t likely to happen in this administration but without adequate resources, FDA is severely constrained in what it can do.  Taylor is telling the industry that FDA is not going to wait for resources to get started on its new legal authority to protect public health. 

Let’s hope this works.

 Bill Marler, the food safety lawyer in Seattle, is asking for responses to the question, “if you had a magic wand, how would you fix the food safety system?” 

I’ve been mulling over his question in light of the recent enactment of the food safety bill, as yet unfunded.  Magic wand in hand, here’s what I’d do:

Create a single food safety agency: the new law is designed to fix the FDA.  It does nothing to fix the USDA’s food safety functions.  These remain divided between the two agencies, with USDA responsible for the safety of meat and poultry, and FDA responsible for everything else.  This division pretends that animal wastes have nothing to do with the safety of fruits and vegetables which, alas, they do. 

Require safety control systems for all foods.  Everyone who produces food should do it safely using proven methods for identifying where hazards can occur, taking steps to prevent those hazards, monitoring to make sure the steps were taken, and—when appropriate— testing to make sure the system is working. 

Apply safety controls from farm to table.  The new law does this for FDA-regulated foods.  But USDA safety regulations begin at the slaughterhouse after animals have already been contaminated in feedlots or in transport.  Everyone involved in food production, even farmers large and small, should be actively engaged in food safety efforts.

Fund food safety through congressional health committees.  For irrational reasons of history, the FDA gets its funding through agricultural committees, not health—even though FDA is an agency of the Public Health Service within the Department of Health and Human Services.   As a consequence, the FDA is at the mercy of appropriations committees whose mandate is to protect agricultural interests.  This anomaly explains why 80% of food safety funding goes to USDA, and only20% to FDA.  The new chair of the House agricultural appropriations committee has made it clear that he does not believe FDA needs any more funding.   Health appropriations committees might view FDA’s role in food safety in a more favorable light.

Fund food safety adequately.  To protect the domestic food supply—and to ensure the safety of imported foods—more money is needed to pay for inspection, testing, and research. 

Give the food agency cabinet-level status.  Everyone eats.  Food safety affects everyone.  Food has critically important economic and food security dimensions, domestically and internationally.   

Require election campaigns to be publicly funded, with no loopholes. This is the only way we will be able to remove corruption from our political system and elect officials who care more about public health than corporate health.

Require Wall Street to rate corporations on long-term sustainability.  Wall Street pressures on corporations to report growth every quarter are at the root of corner-cutting on food safety.  Food corporations should be valued for excellent food safety records and for maintaining high ethical standards in every aspect of their business.

Even a magic wand may not be enough to do this.  It will take more than a magic wand to do this, I fear.  Hey, I can dream.

I listened in on yesterday’s White House conference call announcing that President Obama would sign the Food Safety Modernization Act today.

Speakers said the new bill will give the FDA the tools and authority it needs to help prevent the CDC’s new estimates of the annual burden of foodborne illness: 48 million cases,  180,000 hospitalizations, and 3,000 deaths.

But they barely mentioned the elephant in the room: funding.  The estimated cost of the new provisions is $1.4 billion, which will certainly require new appropriations at a time when Republican lawmakers balk at the mere thought.

Fortunately, reporters pressed hard on this issue.  Where, asked Sheryl Gay Stolberg of the New York Times, is the money coming from?

The FDA’s not-quite-satisfactory answer: the agency already has resources available from increased funding over the last several years and it “will work closely with industry in partnership.”

As reporters for the Washington Post explain today:

Rep. Jack Kingston, who hopes to become chairman of the agriculture subcommittee of the House Appropriations Committee, said that “our food supply is 99.999 percent safe”….He questioned giving the agency more money.

“I think we’ll look very carefully at the funding before we support $1.4 billion,” he told The Associated Press in an interview Monday, speaking of Republicans who will control the House when Congress comes back into session Wednesday.

Lyndsey Layton of the Washington Post noted that Republicans say we already have the safest food supply in the world and don’t need more money.  What, she asked, can FDA do without additional funds?  And when?

But nobody talked about the timing.  New laws require the FDA to engage in interminable rulemaking procedures: writing rules, opening them for public comment, commenting on the comments, re-writing rules, opening them for public comment, and, eventually, arriving at final rules.

What is FDA supposed to do in the meantime?  It can move more quickly by issuing “guidance” or “interim final rules.”

I’m hoping that the FDA is ready for this and will issue such things soon.

My first San Francisco Chronicle “Food Matters” column for the new year deals with some predictions:

Q: Whatever you used as a crystal ball last year turned out to be a pretty good predictor of the most prominent food issues of 2010. How about trying again: What food matters will we be hearing about in 2011?

A: It doesn’t take a crystal ball to figure out what’s coming up with food issues. I’m happy to make predictions, especially since most seem fairly safe.

Dietary guidelines will be released this month. By law, they were due last year and are already late. What will they say? The 2010 guidelines advisory committee recommended eating more fruits, vegetables and whole grains, but introduced a new euphemism – SOFAs, or Solid Fats and Added Sugars – for the “eat less” advice. SOFAs really mean “cut down on fatty meat and dairy products” and “avoid sugary sodas.”

Will government agencies have the nerve to say so? Let’s hope.

The U.S. Department of Agriculture will issue a new food guide. The 2005 pyramid’s rainbow stripes proved impossible to teach and useless to anyone without a computer. I’ve heard a rumor that I will love the new design. I’m skeptical. I liked the original 1992 pyramid. It showed that bottom-of-the-pyramid foods were healthiest, making it unpopular with companies selling top-of-the-pyramid products. But it is healthier to eat some foods than others (see: dietary guidelines).

Will the USDA improve on the 1992 design? We will soon find out.

The fights over food safety will continue. At the last possible moment, Congress passed the food safety bill by a large majority. Now the fights really begin.

Funding will be most contentious, with the actual regulations not far behind. The Congressional Budget Office absurdly considered the bill’s provisions to be “budget neutral.” They are anything but.

The bill’s provisions require the Food and Drug Administration to hire more inspectors just at a time when Republican lawmakers have sworn to cut domestic spending. The FDA also must translate the bill’s requirements and exemptions for small farmers into regulations.

Rule-making is a lengthy process subject to public comment and, therefore, political maneuvering. Watch the lobbying efforts ratchet up as food producers, large and small, attempt to head off safety rules they think they won’t like.

Expect more lawsuits over the scientific basis of health claims. The Federal Trade Commission just settled a $21 million claim against Dannon for advertising that yogurt protects against the flu. The agency also has gone after scientifically unsubstantiated claims that omega-3s in kiddie supplements promote brain development and that pomegranate juice protects against prostate problems. POM Wonderful has already countersued the FTC on grounds that the First Amendment protects commercial speech. I’ll be watching this case carefully.

The FDA will issue new front-of-package label regulations. The FDA has promised to propose an at-a-glance symbol to indicate the overall nutritional value of food products. Food companies like the Guideline Daily Amount spots they are using in the upper corners of food packages because the symbols are factual but nonjudgmental. The FDA, however, is considering red, yellow and green traffic-light symbols that do convey judgments. Food companies say they will not voluntarily use a symbol that tells people to eat less of their products.

Will the FDA have the courage to make traffic lights mandatory? It will need courage. The new British government dealt with the traffic-light idea by summarily dismantling the food agency that suggested it.

Corporations will seek new ways to co-opt critics. Under the guise of corporate social responsibility, food companies have been making large donations to organizations that might otherwise criticize their products. The most recent example is the decision by Save the Children, formerly a staunch advocate of soda taxes, to drop that cause coincidentally at a time when its executives were negotiating funding from Coca-Cola.

Such strategies remind me of how the Philip Morris cigarette company distributed grants to leading arts groups. Expect food companies to use generosity to neutralize critics and buy silence.

School meals will make front-page news. Congress passed the Healthy, Hunger-Free Kids Act last month. Now the USDA must implement it by setting nutrition standards, adding fresh fruits and vegetables (some locally grown) and expanding eligibility.

President Obama has promised to restore the $4.5 billion “borrowed” from the SNAP (food stamp) program to fund this act. The scrambling over the regulations and financing should make excellent spectator sport.

Farm bill advocates will be mobilizing. You might think it too early to be worrying about the 2012 Farm Bill, but I’ve already gotten position papers analyzing commodity and food-assistance issues from groups gearing up to lobby Congress to bring agricultural policy in line with nutrition and public health policy.

I have a personal interest in such papers. I will be teaching a course on the Farm Bill at New York University next fall. Please get busy and write more of them!

Happy new year, and let’s see how my guesses play out.