Currently browsing posts about: FDA

Apparently as a result of a need to cut costs, the USDA is changing the way its inspectors oversee chicken processing.

As Dana Milbank of the Washington Post puts it, this is

a proposal to allow chicken slaughterhouses to inspect themselves — eliminating those pesky federal monitors who have the annoying habit of taking diseased birds out of the food supply.

Even if the Obama administration were inclined to bring down capitalism with an orgy of overregulation, there isn’t enough money in the budget to enforce the rules on the books.  That’s what the chicken fight is about: Spending cuts…are a form of de facto deregulation (my emphasis).

The New York Times account of this policy change notes that inspectors:

had observed numerous instances of poultry plant employees allowing birds contaminated with fecal matter or other substances to pass. And even when the employees try to remove diseased birds, they face reprimands….

The Agriculture Department proposal allows poultry plants to speed up their assembly lines to about 200 birds per minute from 140, hampering any effort to examine birds for defects.

But that’s not all.  The Center for Livable Future at Johns Hopkins  reports that meal made from chicken by-products (in this case, feathers) contains arsenic and antibiotics such as fluoroquinolones that have been banned by the FDA for use in poultry.

A study published in Environmental Science & Technology found fluoroquinolone antibiotics in 8 of 12 samples of feather meal collected from six states and China.

A second study found arsenic in every sample of feather meal tested.

These findings indicate that poultry producers are using these drugs, even though they are not allowed to.

The U.S. poultry industry raises about 9 billion chickens and 80 million turkeys for human consumption each year.  Meal made from their feathers is commonly added to feed for chickens, pigs, cattle, and fish.  This could be a reentry route into the human food supply for such drugs.

Nicholas Kristof explains in the New York Times that these studies also found feather meal to contain

an antihistamine that is the active ingredient of Benadryl…[and] acetaminophen, the active ingredient in Tylenol.  And feather-meal samples from China contained an antidepressant that is the active ingredient in Prozac.

Poultry-growing literature has recommended Benadryl to reduce anxiety among chickens, apparently because stressed chickens have tougher meat and grow more slowly. Tylenol and Prozac presumably serve the same purpose.

Such findings indicate some of the worst problems with industrial poultry production.  They result from pressures to produce chickens cheaply.  The faster chickens can be pushed to grow, the less feed they consume and the cheaper they are to raise.

I don’t know what the best system for inspection might be, but I’m quite sure that leaving food safety oversight to the discretion of the packers is not a good idea.  Neither is speeding up the line.  And neither is feeding chickens drugs that can affect human health.

Here is even more evidence for the need for an overhaul of our food safety system.

A single food safety system anyone?

Today’s New York Times has a long investigative piece on White House interference with FDA decision-making.

The FDA is supposed to make regulatory decisions on the basis of science. When President Obama came into office, he pledged to make decisions based on science and facts rather than ideology:

The truth is that promoting science isn’t just about providing resources—it’s about protecting free and open inquiry…It’s about ensuring that facts and evidence are never twisted or obscured by politics or ideology. It’s about listening to what our scientists have to say, even when it’s inconvenient—especially when it’s inconvenient.

The Times article documents instances in which the administration failed to keep that pledge.  Most of the instances concerned FDA-regulated drugs and devices, but one involves calorie labeling on restaurant menus.

Recall that when President Obama signed the health care reform act in 2010, he signed menu labeling into law.  This required chain restaurants and vending machines to post calorie labels.

The F.D.A.’s first draft of the guidelines — approved by the Department of Health and Human Services and the White House — included rules for movie theaters, lunch wagons, trains and airlines.

But when the FDA released its proposed regulations a year ago, these venues were exempted.

As I said at the time, “Uh oh. Food is sold everywhere these days as anyone who has been to a drug store lately can attest.”

According to the Times’ account, a White House health adviser insisted on these exemptions out of fear that Fox News might view labels on movie popcorn

as an especially silly example of the government intrusions that conservatives often mocked as the nanny state… This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state.

That’s bad enough but I noticed other key omissions in the FDA’s proposed rules.  For one thing, they allow impossibly large ranges such as the 200-to-800 calories that Chipotle posts, for example.

For another, they say nothing about alcoholic beverages.  As I explain in Why Calories Count, alcohol calories count and alcohol is almost as calorie as fat (7 per gram).  The FDA is ducking this ostensibly because it does not have jurisdiction over alcohol (the Treasury Department does).

The FDA needs to take a good hard look at these issues.

It has not yet propose final rules.  Maybe the Times’ article will give the FDA some breathing room and allow it to do the right thing this time.

And the FDA needs to get the rules out fast.  If the Supreme Court strikes down health care reform, will that mean the end of menu labeling as well?

FoodNavigator.com has issued a collection of its recent articles on “natural” and processing.  At issue is the meaning of “natural,” which many people perceive as equivalent to organic or healthy.  As I’ve said before, it isn’t.

Natural has no regulatory meaning.  The FDA merely says (note obfuscating double negatives):

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth.

That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

One thing is clear: “natural” sells food products.

Selling processed foods in a whole food world? Authenticity is key: Consumers increasingly are choosing whole and unprocessed foods – so is it the end of the line for processed food manufacturers? Not if they move with the times, say ingredient suppliers.

Who is driving the clean label agenda, and what does ‘clean’ really mean? Attempts to link clean-labeling policies with the healthy eating agenda have been so successful that research now shows shoppers equate ‘healthy’ with ‘natural’ or ‘minimally processed’ foods.

‘Natural’: The most meaningless word on your food label?  Consumers, the marketers all tell us, want foods that are ‘wholesome’, ‘authentic’, and above all ‘natural’, although few of them can articulate what this means.

‘Processed’ foods are often high in sodium – but what’s a processed food? About 75% of the sodium in our diets comes from processed foods. It’s a regularly cited figure – but what exactly is a ‘processed’ food? Consumers might be surprised.

Processing is a dirty word – but we’ll need more of it to feed the world. Processing has become a dirty word, but we are going to need more processing, not less, in order to feed a growing population, according to professor and head of food science at Penn State University John Floros.

FDA: get to work!

USA Today has picked up the various Internet petitions—SignOn, FoodDemocracyNow, CredoAction, etc— to fire Mike Taylor, the head food safety person at the FDA. 

When the FDA hired Mike Taylor nearly three years ago, I wrote a long post reviewing his complicated employment history: Monsanto, FDA, USDA, Monsanto, private sector, university, FDA—a classic example of the “revolving door.”.    

He was at FDA, although recused, when the agency approved GM foods and denied labeling. 

But at USDA, he was a public health hero to food safety advocates.  He was responsible for installing food safety oversight systems that have greatly reduced contamination outbreaks from meat and poultry.

 He was hired at FDA to do the same thing, which is why I thought his appointment made sense at the time.  I thought he ought to be given a chance.

 He has now become the flashpoint for public anger at FDA over issues that include GM foods but go well beyond them:

• Failure to require labeling of GM foods
• Failure to recognize the scaled-down safety needs of small farmers
• Failure to enforce and punish food safety violations by large producers
• Unfair enforcement of food safety procedures against small producers
• Clamping down on raw milk producers

As I explained to USA Today, I’m a big fan of MoveOn and grass-roots political action, and I’ve been advocating for GM labeling since I was on the FDA Food Advisory Committee in 1994 (if only they had listened to me).

But I don’t exactly get where the “fire Monsanto Mike” movement is coming from nearly three years after he was hired.   Why make the political so personal?

As I told USA Today,

What would firing Mike Taylor do? It would show the muscle of the anti-corporate food movement, says Nestle, “and there’s much to be said for that.” However, she questions whether Taylor leaving would do anything to advance the goals of this loose coalition of activists. “Will it make the FDA listen more carefully to demands that it keep its priorities where the most serious food safety problems are? I don’t know.”

All of the issues mentioned in the petitions are important.  All are complicated.  All deserve serious thought and attention to political goals.  Will firing Mike Taylor advance those goals? 

I don’t see how.

What am I missing here?

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.