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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.

Food politics in action: The CDC announced yesterday that its scientists had recalculated the extent of foodborne illnesses in the United States and cut the estimates by nearly half.

The old mantra (1999):

• 76 million cases of illness
• 325,000 hospitalizations
• 5,000 deaths

The new mantra (2010):

• 48 million illnesses
• 128,000 hospitalizations
• 3,000 deaths

But no, the new figures do not mean that the food supply is safer.  The reduction, says the CDC, is no cause for celebration.  Instead, it only means that tracking methods have improved.     As the editorial accompanying the CDC reports puts it,

Bottom line: with the exception of Vibrio spp., things don’t seem to be getting worse; however, after the initial decline since the USDA regulatory changes in 1995, one does not see evidence of sustained improvement.

The Politics

OK.  Very interesting.  The old estimates weren’t as good as the new estimates.  But why announce what appears to be a huge reduction in foodborne illness now, especially if it really isn’t a reduction?

Is the CDC unaware that a highly contentious food safety bill still lingers in Congress, with only days to go until the congressional term ends?

I sat in on the press conference call yesterday and heard CDC’s weak attempts to minimize the drop in numbers and maximize the fact that foodborne illnesses are still way too high (“one in six Americans”).

I’m not the only one concerned about the timing.  The headline and first sentence in Food Chemical News:

Lower CDC foodborne illness numbers could undercut food safety bill. Just as Congress seems to be on the edge of passing the biggest food safety bill in decades, the Centers for Disease Control and Prevention released today two new studies that reduce the previous estimates of people suffering from foodborne illness in the United States.

CDC officials must be worried.  I hear rumors that CDC press people are complaining to reporters who lead off their stories with the reduced numbers, as most did.

William Neuman in the New York Times, for example, correctly reported:

The federal government on Wednesday significantly cut its estimate of how many Americans get sick every year from tainted food.  But that does not mean that food poisoning is declining or that farms and factories are producing safer food. Instead, officials said, the government’s researchers are just getting better at calculating how much foodborne illness is out there.

And here is USA Today’s Beth Weise, also correctly:

Food isn’t making us as sick as we thought — almost 40% less, in fact. It’s not that the numbers of foodborne illnesses have suddenly decreased, but the Centers for Disease Control and Prevention says its methods for counting have become more precise.

Weise noted: “The new figures are long awaited in the food industry, which believed the previous numbers to be too high.”

Right.  That’s why the timing isn’t so good.

Why is the CDC doing this now?  Maybe this is just a matter of journal publication dates but it would be painfully ironic if CDC’s “better” numbers undercut enactment of the food safety bill.

The Science

That said, the CDC has done a splendid job of making the rationale for these estimates accessible on its main web page for this topic.  The page links to the two scientific papers, one on estimates of illnesses caused by  major pathogens, and the second on unspecified (unidentified) agents.

CDC also presents a detailed table comparing the 1999 and 2010 estimates.

But the 2010 estimates, like the 1999 estimates, are still guesses—just better ones based on methods that were not available in 1999.

Much remains uncertain about the extent of foodborne illness, because they are so difficult to  track:

• Many pathogenic organisms cause foodborne illness; some are characterized, some not.
• Gastrointestinal illness is not always due to food poisoning.
• Most people with foodborne illnesses do not report them to doctors.
• Doctors rarely take stool samples.
• Laboratories test stool samples for only the most frequent pathogens.
• Laboratory tests for pathogens are not always reliable.

Indeed, the CDC estimates that 80% of foodborne illnesses are due to unspecified causes, as are 56% of foodborne hospitalizations and deaths.

The CDC’s conclusion: the burden of foodborne illness is high and keeping pathogens out of the food system is still a good idea.

That, of course, is precisely why it is so important that Congress enact the food safety bill.   Its measures require preventive controls that should apply to pathogens, known and unknown.

Let’s hope Congress understands that foodborne illness is still a serious problem, does not misinterpret the CDC’s new numbers, and passes the legislation as its gift to the new year.

In case you missed it (and how could you?), the FDA Food Safety Modernization Act passed the Senate yesterday by a huge majority.  Thanks to Beth Bainbridge for sending me this link to a map of how the votes went—a graphic, interactive illustration of partisan politics in action.

If you would like to know what the bill really says as opposed to the mythology, you can read a short Summary , or take a look at the entire bill.  And here’s FoodSafetyNews on some of those details.

The next steps: (1) reconciliation with the House version passed a year ago July, and (2) submission of the joint version to President Obama for signature.  This has to be done before this session of Congress expires in just a few weeks.

By all reports, reconciliation will not be so easy.  FoodSafetyNews explains all the things that can derail the bill between now and then, and the list is long and weird (who ever heard of “blue-slipping,” for example?).

Some folks are happy about the Senate action, but some most definitely are not.  FoodSafetyNews summarizes the reactions, as does the New York Times account.

Time is short.  The stakes are high.  Keep fingers crossed.

Update 3:30 p.m.  Final Senate vote postponed until 9:00 a.m. tomorrow!

Today, the Senate is supposed to deal—at last—with S.510, the FDA Food Safety Modernization Act.  Here’s what I’m told is likely to happen (it gives me a headache just to think about it):

• 4:00 pm EST: Senate resumes discussion of S.510.
• 6:30 pm: Senate proceeds to cloture vote on the substitute amendment to S.510.
• Cloture is invoked.
• Post-cloture and upon the use or yielding back of the time allotted in the agreement (1 hour for motions re: 1099 and 4 hours for Coburn motions), the Senate will proceed to vote on the motions in the following order: (1) Johanns (1099 forms–the repeal on a tax burden on small businesses), (2) Baucus (1099 forms), (3) Coburn (earmarks), (4) Coburn (substitute)
• Once those are disposed of, Senate votes on passage of the bill, as amended.
• Observers expect all of this to last well into the night.
• Note: Because all of the amendments are offered as motions to suspend the rules, they require a 2/3rds vote. Final passage requires 51. Cloture requires 60.

And in case your mind is still not made up about how this should go, take a look at today’s commentaries:

Michael Pollan and Eric Schlosser have an op-ed in the New York Times: A Stale Food Fight:

In the last week, agricultural trade groups, from the Produce Marketing Association to the United Egg Producers, have come out against the bill, ostensibly on the grounds that the small farms now partially exempted would pose a food safety threat. (Note that these small farms will continue to be regulated under state and local laws.) It is hard to escape the conclusion that these industry groups never much liked the new rules in the first place. They just didn’t dare come out against them publicly, not when 80 percent of Americans support strengthening the F.D.A.’s authority to regulate food.

And FoodSafetyNews, ever on the job, has three pieces on the bill today (I’m referred to in a couple of them):

• A summary of where the bill stands to date
• An opinion piece by Chuck Jolley demolishing the myths about the bill
• An opinion piece, “Protect Small Farms,” by Roland McReynolds

With a little luck, the Senate will pass the bill tonight, large and small farms will comply with its provisions, and our food supply will be safer as a result.  One can always dream.

Additions: a few more editorial comments, all in favor of passing S.510.

The Sacramento Bee editorial (11-25)

The Minneapolis Star Tribune (11-27)

The Bemidji (MN) Pioneer (11-28)

The Baltimore Sun (11-28 and the 29^th in some editions)

New York Times editorial (11-16)

USA Today (11-23)

Las Vegas Sun (11-23)

Lexington (KY) Herald Leader (11-23)