by Marion Nestle

Currently browsing posts about: FDA

Jun 13 2011

The FDA’s excellent move on arsenic drugs in chickens

For years, as Tom Philpott recounts on his new food and agriculture blog for Mother Jones, public health advocates have fretted about the use of arsenic-containing drugs to kill intestinal parasites and promote growth in chickens.

One such drug is roxarsone, made by Pfizer. Its arsenic is in the organic (carbon-containing) form, which is less toxic than the inorganic form.

But, as the New York Times explained, evidence has been accumulating that the organic form can change into the more toxic, inorganic form, a known carcinogen.

As reported in Food Safety News,  the Center for Food Safety, the Institute for Agriculture and Trade Policy, and several other consumer and agriculture groups petitioned FDA to ban the drug three years ago.

Last week, the FDA announced that the agency had done its own feeding tests.  Chickens fed organic roxarsone had higher levels of inorganic arsenic in their tissues.  The FDA got Pfizer to “voluntarily” withdraw the drug from the market.

The surprise here is not the FDA’s delay in dealing with this drug.  The big surprise is that the FDA did its own testing.  As the Times put it:

The F.D.A. once routinely conducted its own studies of animal and human drugs, but limited budgets led the agency to eliminate much of its scientific and laboratory capacity over the years. The roxarsone study is a triumph for agency scientists but one unlikely to be repeated very often. The agency asked for $183 million in additional funds for food safety efforts next year, but House Republicans have instead proposed cutting $87 million.

Drug companies cannot be expected to do their own testing if there is any chance that the tests will show something not in their best interest.  If independent federal agencies don’t do these kinds of studies, who will?

I can remember when the FDA housed a group of researchers doing outstanding work on food allergies in the 1990s.  The FDA closed down that lab when it was given additional responsibilities by Congress with no additional funding.

The FDA is a public health agency.  Its job is to protect the public against unsafe food contaminated with bacteria or antibiotics such as roxarsone.  The agency gets high marks for taking this on.  And Congress needs to support the FDA’s research mission.

 

Jun 11 2011

The science and politics of E. coli in sprouts

German authorities now say that  sprouts grown on an organic farm in Lower Saxony are the source of their E. coli O104:H4 outbreak, now responsible for more than 30 deaths and 3,000 illnesses, 750 of them severe kidney disease.

The epidemiological studies point to sprouts after all.

Sprouts, as I mentioned in an earlier post, are a prime suspect in microbial outbreaks.   They have been implicated in many outbreaks in the United States.  This is because sprouts are sprouted from minute seeds that are hard to clean, as shown in this microscopic view:

 

 

 

As Food Safety News explains in a long discussion of this problem, the seeds need to be dumped in bleach to kill bacteria.  It’s also a really good idea to test the wash water to make sure it is free of pathogens.

The seeds are sprouted in water at room temperature, “a warm, moist climate — just perfect for a bacteria’s social life and subsequent reproduction.”

The FDA has been aware of this problem for a long time, as shown by this brief chronology:

The Food Safety Modernization act passed last year finally gives FDA the authority to require food safety controls for sprouts.

The German outbreak ought to be a wakeup call for this industry in the United States.  Sellers of bean sprouts market them as health foods but say little about how unsafe they are if eaten raw.

It also ought to be a wakeup call for consumers.  If you aren’t absolutely sure the seeds come from a clean source, cook your sprouts.

Jun 6 2011

The German E. coli outbreak: now it’s sprouts?

I haven’t said anything about the E. coli 0104 crisis in Germany up to now because I’ve been waiting for the evidence.  Without evidence, the source of the outbreak remains uncertain.

Yesterday, the German minister of agriculture announced that sprouts are the cause.  But are they?

What  is known without question is that the outbreak is deadly serious.  Bill Marler reports these shocking numbers as of June 5:

Deaths = 22 (21 in Germany, 1 in Sweden)

Illnesses = 2,243 (2,153 in Germany, and 90 more in 10 other European nations and the U.S.)

Cases of Hemolytic Uremia Syndrome (HUS) = 627

Why shocking?  This is a devastating disease, excruciatingly painful, with a high probability of causing lifelong complications.  And the disease is almost entirely preventable by following standard food safety procedures.

The idea that the cause is sprouts, and German sprouts at that, comes as a surprise.  Why?  First, sprouts are a frequent cause of foodborne illness and should have been high on the list of suspected foods.  Second, sprouts did not turn up in the case-control studies.

Instead, investigators examined cucumbers, lettuce, and tomatoes (and, in the process, put Spanish cucumber producers out of business).  As Marler explains, the German authorities didn’t want to take a chance, given the results of their investigation.

The case-control investigation was conducted by the Robert Koch Institute, the German equivalent of our CDC.

  • The cases: From May 29 to June 2, investigators interviewed 46 affected patients from Bremen, Hamburg and Lübeck about the foods they had eaten.
  • The controls: They interviewed 2,100 people who were not sick but were of similar age group, sex and region of residence.
  • The results:

Food Reported Eaten         % By Cases     % By Controls

Lettuce                                        84                           47

Cucumbers                                 75                           50

Tomatoes                                   80                            63

95% of the Cases had eaten at least one of the three vegetables.

This evidence strongly implicates these vegetables.  But did they not look for sprouts?

In another related study of people from a Frankfurt business company who had become ill, those who had eaten from the salad bar in the company cafeteria had a 7-fold increased risk of developing bloody diarrhea than those who had not.  No such association was seen for other foods investigated, such as dessert, fruit and asparagus.  Sprouts are not mentioned.  How come?

In trying to figure out what’s going on here, a BBC World News report raises even more questions (my emphasis):

The agriculture minister for Lower Saxony, Gert Lindemann, said there was a clear trail of evidence pointing to a plant nursery south of Hamburg [as the source of the contaminated sprouts].

The nursery has been closed, though officials say the outbreak’s source cannot yet be definitively confirmed.

…Mr Lindemann said epidemiological studies all seemed to point to the plant nursery in Uelzen in the state of Lower Saxony, about 100km (62m) south of Hamburg – though official tests had not yet shown the presence of the bacteria there.

“Further evidence has emerged which points to a plant nursery in Uelzen as the source of the EHEC cases, or at least one of the sources,” he said.  [What evidence?]

…Gert Hahne, a spokesman for the Lower Saxony agriculture ministry, earlier told the Associated Press news agency that many restaurants in which people ate before becoming ill had recently taken delivery of the sprouts. [Guilt by association]

He said authorities would still maintain a warning against eating tomatoes, cucumbers or lettuce.

The health ministry in Berlin said it was still waiting for results from tests on the beansprouts, Germany’s DPA news agency reported.

And the head of the Robert Koch Institute (RKI), Germany’s national disease centre, was also reported as saying that the cause of the outbreak could not yet be confirmed.

So: are sprouts the cause?

By this time, the outbreak is slowing down as the contaminated foods make their way through the food supply.

Could this happen here?  You bet.

If ever there was a time to give the FDA more resources, now is it.  The FDA now has the authority to impose standard food safety procedures on food producers and to require safety measures for the foods we import.   But Congress wants to cut the agency’s budget, and badly.

Now would be a good time to let congressional representatives know that we need a stronger FDA.   And while you are at it, let the USDA know that you think it would be a good idea to regulate other forms of toxic E. coli as adulterants in the same way they regulate E. coli 0157:H7. There is plenty government could do right now to protect us from outbreaks like this one.

A word about sprouts:

How come sprouts are such frequent sources of food safety problems?

Sprouts are grown from tiny seeds that are impossible to wash thoroughly enough to ensure that they are free of harmful bacteria.  The seeds are sprouted in water that must be changed several times a day.  This water is an excellent growth medium for bacteria.  That is why FDA guidance says sprout producers ought to test the wash water for harmful bacteria.

Under the new legislation, the FDA has the authority to enforce this guidance.  But does it have adequate personnel?  Unlikely, given the current stance in Congress.

This just in:  No, it’s not sprouts, according to this bulletin from Food Chemical News:

The latest news, reported this morning by both the Associated Press and BBC, is that 23 of 40 samples of organic sprouts taken from the Gaetnerhof farm in the Lower Saxony region of Germany have tested negative for the bacteria. Tests on the other samples have yet to be returned.

May 28 2011

Redesign the Nutrition Facts label? Here’s your chance!

Utne reader has just announced the most interesting contest: redesign the food label.

The contest is sponsored by Good magazine and the UC Berkeley Graduate School of Journalism’s News21 program.  It is called the Rethink the Food Label project.

Anyone can enter.  Just think of some way that would make the label more useful.

The FDA is currently working on doing just that, and for good reason.  The label is so hard to use that the FDA devotes a lengthy website to explaining how to understand and use it.

This too is understandable.  The Nutrition Facts label is the result of regulations in response to the Nutrition Labeling and Education Act of 1990.  When the FDA started writing regulations to implement the Act, it tested consumer understanding of a bunch of potential designs.

The result?  Nobody understood any of them.  The FDA, under pressure to complete the regulations by the congressional deadline, chose the option that was least poorly understood–the best of a bad lot.

Surely someone will come up with something better than this?  The deadline for submission: July 1. One of the judges is Michael Pollan. Give it a try!

 

May 26 2011

That pesky GMO issue again

The L.A. Times has one of the better stories I’ve seen lately about genetically modified (GM) foods.  I don’t usually write much about this topic because there is so little new to say about it.

I’ve been writing about GM foods for 20 years now and I’d call it a stalemate.  The industry says:

  • GM foods are absolutely necessary to feed the world.
  • Farmers love them.
  • They are harmless.

Farmers do like using them because they do not have to do as many pesticide applications or worry as much about weeds.

But the first and third points are highly debatable, as the article discusses.

I worry most about two aspects of GM foods:

  • They encourage corporate control of the food supply and monoculture (never good ideas)
  • They do not give consumers choices because they aren’t labeled.

The LA Times illustrates both points in one terrific graphic:

 

The states are starting to act, but this is really the FDA’s issue.  It’s time to get the FDA to reverse its 1994 decision not to label GM foods.

 

 

May 24 2011

Do you want calories listed for alcoholic drinks? Tell FDA by July 5

In April, the FDA released proposed rules for listing calories on menu labels (see previous post).  One surprising omission was an exemption for alcoholic beverages.  The surprise was that FDA had included alcoholic beverages in earlier versions.

The FDA’s reason for omitting alcohol is that these drinks are regulated by the Treasury Department, which proposed rules for calories on the labels of such drinks.  Yes it did, but that was at least four years ago and Treasury has done nothing since.  And Treasury has never said a word about menu boards.

Jurisdiction cannot be the real reason.  FDA does not regulate meat and poultry (USDA does) but its proposed regulations cover those foods.

If you think the FDA should require restaurants to display calories for alcoholic beverages, now is the time to say so.

I think consumers’ right to know is a sufficient reason for demanding calorie labeling on alcoholic beverages, but if you want more, the Marin Institute  lists useful talking points.

  • Alcoholic beverages contain calories and few nutrients.
  • It is difficult for drinkers to calculate the number of calories contained in a specific alcoholic beverage on their own.
  • Congress did not explicitly exclude alcoholic beverages from food labeling requirements.
  • The FDA has jurisdiction over the regulation of alcoholic beverages for health purposes.
  • The TTB [Treasury Department agency] continually fails to act regarding the labeling of alcoholic beverages.
  • Exempting small alcohol producers can remove burden of obtaining nutritional information.

If you are convinced by these arguments, or have others of your own, be sure to share them with FDA.  Do it right away.  The deadline is July 5.

May 20 2011

FDA’s focus on preventing food safety problems

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

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

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

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

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

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

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

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

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

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

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

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

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

May 18 2011

FDA’s limited ability to regulate food imports

The congressional watchdog agency, the Government Accountability Office (GAO), has just published a new report comparing the way the FDA deals with inspections of imported foods to methods used by the European methods.  The title says it all: “FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources.”
GAO says:
FDA’s program is generally limited to enforcing the Hazard Analysis and Critical Control Point—the internationally recognized food safety management system—by conducting inspections of foreign seafood processors and importers each year.
These inspections involve FDA inspectors reviewing records to ensure the processors and importers considered significant hazards, including those resulting from drug residues if the seafood they receive are from fish farms.
The inspectors generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.
Here are some of GAO’s more disturbing conclusions:
  • Aquaculture assessments have been limited by FDA’s lack of procedures, criteria, and standards. In contrast, the EU reviews foreign government structures, food safety legislation, the foreign country’s fish farm inspection program, and visits farms to ensure that imported seafood products come from countries with seafood safety systems equivalent to that of the EU.
  • FDA’s sampling program does not generally test for drugs that some countries and the EU have approved for use in aquaculture. Consequently, seafood containing residues of drugs not approved for use in the United States may be entering U.S. commerce.
  • FDA’s sampling program is ineffectively implemented. For example, for fiscal years 2006 through 2009, FDA missed its assignment plan goal for collecting import samples by about 30 percent.
  • In fiscal year 2009, FDA tested about 0.1 percent of all imported seafood products for drug residues.
  • FDA’s reliance on 7 of its 13 laboratories to conduct all its aquaculture drug residue testing raises questions about the agency’s use of resources.
  • FDA has inspected 1.5 percent of Chinese seafood processing facilities in the last 6 years.

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

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

 

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