Currently browsing posts about: FDA

I am a daily reader of FoodNavigator-USA.com, a newsletter aimed at the food industry.  Occasionally the site collects posts on one subject.   This collection deals with food safety since Congress passed the new law more than a year ago.  The Interactive Timeline is particularly useful.

• Interactive timeline: The Food Safety Modernization Act:  A year ago, President Obama signed the Food Safety Modernization Act into law. FoodNavigator-USA tracks its development and implementation – as well as all the controversy along the way – in our exclusive interactive timeline.
• Expect ‘considerable growing pains’ as FSMA kicks in, warns lawyer : While the Food Safety Modernization Act (FSMA) will undoubtedly “raise the floor” and increase confidence in the US food supply, experts are predicting “considerable growing pains” as the industry gets to grips with the new legislation.
• Life under the Food Safety Modernization Act: Tracing, tracking and brand protection:  The ability to track and trace ingredients is likely to be a major focus for food manufacturers as the Food Safety Modernization Act (FSMA) is rolled out – but the most important consideration for companies is brand reputation, according to a FSMA specialist at ADT Security Services.
• FDA: We’ll publish FSMA foreign supplier verification rules ‘soon’: The FDA has missed its January 4 deadline for publishing details of how it will regulate imported food under the Food Safety Modernization Act (FSMA), but says it will update the industry “soon”.
• FDA hails ‘significant progress’ under year-old food safety law:  The Food and Drug Administration claims it has made significant progress with regulatory developments related to the Food Safety Modernization Act since the bill was signed into law a year ago, according to its one-year progress report.

A study published online in the American Journal of Public Health fiddled around with red (avoid) and green (eat me) labels on items in a hospital cafeteria.

The investigators measured sales before the start of the intervention.  About a quarter of items sold were in the red category and 42% were green—these hospital workers were already making healthy choices.

The intervention took place in two 3-month phases.  The first phase just involved traffic light labels.  In the second phase, the investigators moved the items around to make the green-labeled products more visible and accessible.

The results: labels alone led to decreases in sales of red-labeled items and increases in sales of those with green labels.

For example, sales of red-labeled drinks decreased by 16.5%.  When the drinks were made less accessible, sales declined by an additional 11.4% (sales of bottled water increased).

No wonder the food industry in Great Britain fought so hard against traffic light front-of-package labeling.  No wonder the Grocery Manufacturers Association and Food Marketing Institute much prefer their own guaranteed-not-to-work system.

And data like these surely explain why the FDA is taking so long to do anything with the Institute of Medicine’s proposed labeling system—not exactly traffic lights, but pretty close.

This study provides further evidence for the value of such schemes for helping people make healthier choices.

FDA: get busy!

The food and chemical industries are lobbying hard against what is expected to be a tough report from the Environmental Protection Agency (EPA).

The report will set an upper limit for safe consumption of dioxins.

Most Americans consume dioxins at levels higher than this standard, mostly from food.

About 90% of dioxins come from foods, particularly high-fat animal foods.

Dioxins mainly enter the food chain as by-products of industrial processes.  To a lesser extent, they also come from natural processes such as volcanoes and forest fires.  They contaminate land and sea, are consumed in feed, move up the food chain, and end up in the fatty parts of meat, dairy products, and seafood.

Dioxins accumulate in fatty tissues.  They increase the risk of human cancer more than any other industrial chemical.

The EPA is expected to recommend an intake limit of 0.7 picograms of dioxin per kilogram body weight per day.  A picogram is one trillionth of a gram.  The World Health Organization and European Union limit is higher—from 1 to 4 picograms per kilogram per day.

The food and chemical industries argue that the proposed EPA limit is too low.

The EPA thinks less is better.  Dioxins are toxic and Americans typically consume amounts within the European range.   A single hot dog can contain more dioxin than the proposed limit for a 2-year-old.

Dioxin levels in the United States have been declining for the last 30 years due to reductions in man-made sources. But they break down slowly and persist for a long time in the environment.

How to avoid them?  The best way is to eat less high-fat meats, dairy foods, and seafood.

No wonder the food industry is alarmed.

A “Food Industry Dioxin Working Group” of trade associations such as the International Dairy Foods Association, the American Frozen Food Institute, and the National Chicken Council wrote to the White House:

Under EPA’s proposal…nearly every American – particularly young children – could easily exceed the daily RfD [reference dose] after consuming a single meal or heavy snack…The implications of this action are chilling.

Since the agency contends the primary route of human exposure to dioxin is through food, this could not only mislead and frighten consumers about the safety of their diets, but could have a significant negative economic impact on all US food producers.

These groups singled out the media for particular blame:

The media will inevitably report on this change and in all likelihood misinterpret the RFD as a ‘safe limit’. As a result, consumers may try to avoid any foods ‘identified’ as containing or likely to contain any dioxin.

Eat more fruits and vegetables anyone?

Congressman Ed Markey (Dem-MA) is urging the EPA to get busy and release its report:

The American public has been waiting for the completion of this dioxin study since 1985 and cannot afford any further delays…A baby born on the day the EPA completed its first draft health assessment would be 27 years old today. I’d like to see the final EPA analysis before it turns 28.

Let’s hope the EPA does not cave in to industry pressure and releases the report this month as promised.

Technical note:

“Dioxins” collectively refers to hundreds of chemical compounds that share certain structures and biological characteristics. They fall into three closely related groups: the chlorinated dibenzo-p-dioxins (CDDs), chlorinated dibenzofurans (CDFs) and certain polychlorinated biphenyls (PCBs). The most studied is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).  PCBs are no longer produced in the U.S.

References:

• EPA
• FDA
• Food Safety News
• Food Quality News

According to rumors passed along by Dan Flynn at Food Safety News via the Hagstrom Report (an agricultural subscription news service costing $999 a year), the Office of Management and Budget wants to merge federal agencies, among them the food safety components of FDA and USDA.

Rumors are that the Obama administration wants to do this to make “food safety independent of USDA, which primarily exists to market and promote American farm products.”

If this happens, it could be one major benefit of cost-cutting measures.  At the moment, USDA gets about three quarters of the total appropriation for food safety (for roughly one quarter of the food supply) whereas FDA gets one quarter of the appropriation for three quarters of the food supply.

This inequity is a result of the way Congress funds the FDA—through agricultural appropriations committees, not, as any sensible person might expect, through health committees (this too needs to change).

The merger also would eliminate the dysfunctional distinctions between regulations for meat and poultry (USDA) and practically all other foods (FDA).   A merged agency could deal with the unpleasant fact that animal waste is the cause of many food safety problems with fruits and vegetables.

The idea of a single food safety agency is not new.  The Government Accountability Office (GAO) has been calling for its creation since 1990 or earlier, most recently in 2011.

In the 2011 report, GAO said, as it has for years:

Fragmented food safety system has caused inconsistent oversight, ineffective coordination, and inefficient uses of resources…The Department of Agriculture’s (USDA) Food Safety and Inspection Service and the Food and Drug Administration are the primary food safety agencies, but 15 agencies are involved in some way.

These, GAO points out, administer at least 30 food-related laws.

In addition, GAO urges Congress to ask the National Academy of Science to consider several organizational structures that might work better than the current system:

• A single food safety agency, either housed within an existing agency or established as an independent entity, that assumes responsibility for all aspects of food safety at the federal level
• A single food safety inspection agency that assumes responsibility for food safety inspection activities, but not other activities, under an existing department, such as USDA or FDA
•  A data collection and risk analysis center for food safety that consolidates data collected from a variety of sources and analyzes it at the national level to support risk-based decision making
• A coordination mechanism that provides centralized, executive leadership for the existing organizational structure, led by a central chair who would be appointed by the president and have control over resources

The rumors do not say which of these options is favored.

Not everyone is as enthusiastic about a single food safety agency as I am, in part because this and other issues remain to be resolved: where the new agency would go and what its resources might be.

And, as food safety lawyer Bill Marler points out, legal matters are also at stake:

We can’t overlook the legal issues in food safety. Right now there are too few legal consequences for sickening or killing customers by selling contaminated food. We should impose stiff fines, and even prison sentences, for violators, and even stiffer penalties for repeat violators.

So, let’s make some progress in stopping food poisoning and then later pick out the new stationery.

Former USDA official Richard Raymond, writing in Food Safety News argues:

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

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

He suggests reading the comment posted on Dan Flynn’s article from Carol Tucker Foreman, also a former USDA official and a long-time food safety advocate.

The major point of her very long comment is that moving USDA’s meat and poultry inspection responsibilities to FDA

Would likely reduce the current level of health protection provided by food safety laws and curtail the progress that has been made in reducing foodborne illness.

The FDA, saddled by lack of funds, sufficient legal authority, and food safety leadership has been criticized…for its inability to provide a decent level of food safety protection in the domestic and imported food products it regulates.

…Today the FSIS [USDA] has surpassed the FDA in some areas. The agency has adequate resources and high official status in a relatively small Cabinet agency…FDA, despite its new law, is still strapped for funds, burdened by its low position at HHS and the need to manage multiple agendas…Reorganization would not address the continuing problems of either agency.

…We’re confident that trying to move other agencies to the FDA or HHS won’t save money. In fact we are confident it would reduce the effectiveness of the meat and poultry inspection program…leading to a potential increase in foodborne illness and the related costs. That makes it bad policy and a bad bargain.

But what if the new hypothetical single food safety agency does not go to FDA?  What if it goes someplace independent of either agency?   And what if the new entity started out with the highest possible safety standards, funded adequately?

If we are dealing with rumors, we can deal with dreams too, no?

Update, January 29:  Food SafetyNews says all rumors are false.  This isn’t going to happen because the meat industry doesn’t want it to happen.

Bacterial contamination of meat is an ongoing problem and everyone wishes for an easy fix—one that does not require meat producers and packers to prevent contamination.

Irradiation works, but raises feasibility and other concerns.

How about electrocution?

Food Production Daily reports that hitting meat with electrical current reduces toxic E. coli O157:H7 on meat surfaces by 2 log units.

The research report says researchers inoculated meat with the bacteria and then applied electrical current.  But by inoculation they must mean just on the surface, because they only counted surface bacteria.

Surface bacteria, alas, are not the problem.  Searing meat effectively kills surface bacteria.   Bacteria in the interior (of hamburger, for example) survive unless the meat is well cooked.

And 2 log units is unlikely to be good enough for bacteria that cause harm at low doses, as this kind does.  The FDA requires a 5 log reduction for fresh juices, for example.

I wish researchers would apply their talents to figuring out how to keep toxic bacteria from getting into and onto animals in the first place.  Then we wouldn’t have to worry about designing techno-fixes to deal with contaminated meat.

By this time everybody knows—or ought to—that the non-therapeutic use of antibiotics in farm animals is a threat to human health. 

Using antibiotics to promote animal growth or reduce feed requirements is a bad idea.  Widespread use of these drugs induces microbial resistance, making the antibiotics ineffective against human disease.

So you would think that public health agencies would be falling all over themselves trying to reduce antibiotic use in farm animals.  No such luck.  Proposals to restrict use of antibiotics for therapeutic purposes runs up against the interests of meat and poultry industries. 

The best the FDA can do falls far short of what is needed.  Witness its pussy footing on cephalosporin drugs.

On January 4, the FDA proposed a final rule on use of cephalosporin drugs in animal agriculture.

The rule bans some “extralabel” (i.e., unapproved) uses of cephalosporin antimicrobial drugs in some food animals—cattle, swine, chickens, and turkeys. 

As the FDA’s press release explains, it is banning use of cephalosporins:

• At unapproved dose levels, frequencies, durations, or routes of administration
• In forms that are not approved for use in cattle, swine, chickens, and turkeys because they are intended for humans or companion animals
• For disease prevention

These are all good things but should do much more. 

Cephalosporins are used in humans to treat pneumonia, skin and soft tissue infections, pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

If bacteria are resistant to cephalosporins, doctors have fewer options for treatment and these are less effective or more harmful.

 What is troubling is that the FDA proposed a more restrictive ban in 2008 but reversed the decision under pressure from industry veterinarians.

As Food Safety News reports, the new order, which is scheduled to go into effect in April, follows a couple of previous notices published last year. 

In November, the FDA turned down consumer petitions calling for a ban on the non-therapeutic use of a broader range of antibiotics in farm animals. 

In December, the FDA admitted that it had given up a plan first announced in 1977 to withdraw approval for penicillin and tetracyclines in animal feed.

Apparently, the FDA has decided to try to get drug companies and the meat and poultry industries to reduce the use of antibiotics voluntarily.

Good luck with that. 

Philip Brasher writes in the Des Moines Register that the new restrictions will hit hardest on the chicken industry, which uses the drugs for disease prevention. 

He says the FDA’s 2008  proposal would have blocked hog producers from treating illnesses that aren’t listed on the label.   He quotes the chief veterinarian for the National Pork Producers Council:

We are pleased that FDA balanced the need to protect animal health with their concerns about resistance.

This is not about animal health.  Nobody is trying to stop the use of antibiotics to treat animal disease.  At issue is their use as growth promoters or feed savers.

Congresswoman Louise Slaughter (Dem-NY) understandably views the FDA’s action as “tepid.”  She has introduced the  Preservation of Antibiotics for Medical Treatment Act to deal with the problem of non-therapeutic antibiotic use.  Of the FDA’s proposal, she said:

This is a modest first step by the FDA…but we’re really just looking at the tip of the iceberg. We don’t have time for the FDA to ploddingly take half-measures. We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs. We need to start acting with the swiftness and decisiveness this problem deserves.

We do indeed.  Her bill deserves much support.   Public health should not be left up to the meat, poultry, and drug industries to decide.

Addition, January 12: I missed the New York Times editorial on this issue:

It’s time for the F.D.A. to consider the public’s health as carefully as it considers the interests of intensive agriculture and pharmaceutical companies.

My monthly Food Matters (first Sunday) column in the San Francisco Chronicle takes out a crystal ball…

Q: What’s on the food politics agenda for 2012? Can we expect anything good to happen?

A: By “good,” I assume you mean actions that make our food system safer and healthier for consumers, farmers, farm workers and the planet.

Ordinarily, I am optimistic about such things. This year? Not so much. The crystal ball is cloudy, but seems to suggest:

Political leaders will avoid or postpone taking action on food issues that threaten corporate interests. Sometimes Congress acts in favor of public health, but 2012 is an election year. Expect calls for corporate freedom to take precedence over those for responsible regulations. Maybe next year.

Something will happen on the farm bill, but what? Last fall’s secret draft bill included at least some support for producing and marketing fruits and vegetables, and only minimal cuts to SNAP (food stamps). Once that process failed, Congress must now adopt that draft, start over from scratch or postpone the whole mess until after the election.

SNAP participation will increase, but so will pressure to cut benefits. With the economy depressed, wages low and unemployment high, demands on SNAP keep rising. In 2011, SNAP benefits cost $72 billion, by far the largest farm bill expenditure and a tempting target for budget cutters. While some advocates will be struggling to keep the program’s benefits intact, others will try to transform SNAP so it promotes purchases of more healthful foods. Both groups should expect strong opposition.

Childhood obesity will be the flash point for fights about limits on food marketing. The Lancet recently summarized the state of the science on successful obesity interventions: taxes on unhealthy foods and beverages, restrictions on marketing such items, traffic-light front-of-package food labels, and programs to discourage consumption of sugar-sweetened drinks and television viewing. Expect the food industry to continue to get Congress to block such measures, as it did with U.S. Department of Agriculture school nutrition standards (hence: pizza counts as a vegetable).

The Federal Trade Commission will postpone release of nutrition standards for marketing to children. Although Congress asked for such standards in the first place – and the standards are entirely voluntary – it just inserted a section in the appropriations bill requiring a cost-benefit analysis before the FTC can release them. Why does the food industry care about voluntary restrictions? Because they might work (see previous prediction).

The Food and Drug Administration will delay issuing front-of-package labeling guidelines as long as it can. The FDA asked the Institute of Medicine for advice about such labels. The institute recommended labels listing only calories, saturated and trans fat, sodium and sugars – all nutrients to avoid. Although the institute did not mention traffic-light labels, it did recommend check marks or stars, which come close. The food industry much prefers its own method, Facts Up Front, which emphasizes “good-for-you” nutrients. It is already using this system. Will the FDA try to turn the institute recommendations into regulations? Maybe later.

The FDA will (still) be playing catch-up on food safety. The FDA got through the 2011 appropriations process with an increase of about $50 million for its inspection needs. This is better than nothing but nowhere near what it needs to carry out its food safety mandates. The FDA currently inspects less than 2 percent of imported food shipments and 5 percent of domestic production facilities. The overwhelming nature of the task requires FDA to set priorities. Small producers think these priorities are misplaced. Is the FDA going after them because they are easier targets than industrial producers whose products have been responsible for some of the more deadly outbreaks? Time will tell.

On the bright side, the food movement will gather even more momentum. While the food industry digs in to fight public health regulations, the food movement will continue to attract support from those willing to promote a healthier and more sustainable food system. Watch for more young people going into farming (see Chronicle staff writer Amanda Gold’s Dec. 25 article) and more farmers’ markets, farm-to-school programs, school meal initiatives, and grassroots community efforts to implement food programs and legislate local reforms. There is plenty of hope for the future in local efforts to improve school meals, reduce childhood obesity, and make healthier food more available and affordable for all.

And on a personal note: In April, University of California Press will publish my co-authored book, “Why Calories Count: From Science to Politics.” I’m hoping it will inspire more thinking and action on how we can change our food system to one that is better for people and the planet.

Happy new year!

In preparation for the holiday season, Secretary of Health and Human Services Kathleen Sebelius and Agriculture Secretary Thomas Vilsack held a press conference  to promote the departments’ efforts on food safety.

They announced release of the administration’s progress report from its Food Safety Working Group.

They also highlighted additional places to get government information about food safety at home:

• Food Safety Blog
• FoodSafety.gov 
• Tips on Holiday Food Safety

I didn’t pay much attention to these announcements until I read the slightly snarky account in Food Chemical News (December 22). 

The Obama administration patted itself on the back today with a new report that both lists the accomplishments over the past three years of its Food Safety Working Group (FSWG) and identifies the group’s top priorities for the coming year.

Released just minutes before a short media call that served as more of a pep rally, The Federal Food Safety Working Group Progress Report, a 31-page document, summarizes for stakeholders a host of activities that have taken place at government agencies over the past three years related to detecting foodborne pathogens, enhancing surveillance, responding to food safety problems, improving food safety at the retail level and educating consumers.

The list of the administration’s food safety accomplishments is long and detailed, and many are impressive.

But what the report does not say is telling.  Neither the USDA nor FDA have the resources or power to require the industries they supposedly regulate to produce safe food.

As Mark Bittman explains in his Opinionator column in the New York Times, politics defeats even the most rational and thoroughly science-based safety measures, leaving the FDA unable to do much more than politely request “voluntary guidance” of industry.

Bittman focuses on the political barriers to doing what the FDA has been asking for since 1977:  a ban on the use of antibiotics for non-therapeutic purposes, in this case to make food animals grow faster.   The result: “Bacteria 1, FDA 0.”

Here’s the nut: The F.D.A. has no money to spare, but the corporations that control the food industry have all they need, along with the political power it buys.

That’s why we can say this without equivocation: public health, the quality of our food, and animal welfare  are all sacrificed to the profits that can be made by raising animals in factories….Animals move from farm to refrigerator case in record time; banning prophylactic drugs would slow this process down, and with it the meat industry’s rate of profit.

Lawmakers beholden to corporate money are not about to let that happen, at least not without a fight.

For more than 20 years, the Government Accountability Office has called for creation of a single food safety agency that unites the safety oversight functions of the FDA and USDA and has the authority to require food to be produced safely.

In this Congress?  Hopeless.

But Congress can be changed—and that’s a worthy thought for the new year.