Tag: fda

FDA and Food Safety: Failing Grade

  • Another scare came a few years ago, when spinach was found to be tainted with E. Coli (Photo courtesy of the USDA)

In the wake of this year’s tainted peanut butter scare, Congress is getting ready to approve changes to the Food and Drug Administration. Lawmakers want to give the American public more confidence in the safety of the food supply system. But some people doubt they will be able to
make real change. Julie Grant reports:

Transcript

In the wake of this year’s tainted peanut butter scare,
Congress is getting ready to approve changes to the Food
and Drug Administration. Lawmakers want to give the
American public more confidence in the safety of the food
supply system. But some people doubt they will be able to
make real change. Julie Grant reports:

Gwen Rosenberg is a mom. She has four boys to feed. So
she’d like to be able to trust that the food supply is safe.

But when Rosenberg heard that 8 people died after eating
peanut products earlier this year, and hundreds more got
sick, it confirmed her beliefs: that the Food and Drug
Administration isn’t making sure food is safe.

“There shouldn’t be stories that come out that reveal that the
peanut plant hasn’t been inspected for years. Or when it
was inspected, there was rat feces. They’re not doing their
job.”

Rosenberg wants the FDA to crack down on food
manufacturers. She says they need inspect more – and shut
down facilities when they find dangerous conditions. She
was appalled when she realized the FDA has no authority to
recall tainted foods.

“The fact that they don’t have recall authority essentially
neuters the FDA. I mean, how are we supposed to take
anything they say or do seriously if they end result is, ‘well,
we can’t force you to do this?’ Well, thanks for the
community service message not to eat the tainted peanut
butter, but you’re not actually making me any safer.”

In the case of the Peanut Corporation of America, a test
found salmonella in its products. It retested. When the test
came out negative, it went ahead and shipped out the
products.

And the FDA had no recall authority. Congressman Bart
Stupak says that’s just wrong. He’s co-sponsoring a food
safety bill that would give the FDA some authority in cases
like this.

“What the FDA can do, shut ‘er down. Prove to me that you
cleaned it up. Prove to me, where did you destroy this
product. Give me the facts. They can’t give you the facts,
shut ‘er down right now. Let’s not wait ten days.”

But leaders in the FDA don’t think recall authority would
have made much difference in the tainted peanut product
case.

David Acheson is Associate Commissioner for foods at the
FDA. Once people started getting sick, he says most
companies using the Peanut Corporation of America’s
products voluntarily recalled their cookies and crackers.

“There’s no suggestion that having mandatory recall is a
panacea to solving food safety problems. It’s one more tool
that would be used from time to time when the situation
warrants it, but it’s not the answer to modernizing food
safety.”

Acheson says the real problem is that the FDA is so busy
reacting to public health threats – to putting out fires – that it
can’t get ahead of the problems and fix the food safety
system.

He says the food system needs preventive controls.

There are a lot of points in the food supply chain where
hazards can creep in: when the food is being grown,
processed, distributed, or sold in a store. Acheson says the
food industry needs to identify control points for each food –
where they are most at risk at becoming unsafe.

“Is it a wild animal in a field, is it the water supply for the
spinach, is it the temperature in my freezer in a retail store.
And all these things in between where things can go wrong
and food can either become contaminated or if there is a low
level of contamination then bacteria can grow.”

Once those control points are identified, Acheson says the
FDA needs to do more inspections – to make sure food is
being handlled safely from farms fields to grocery stores.

But that’s going to cost money.

So Congress is considering charging companies fees to pay
for those inspections.

Food manufacturers don’t like that idea. We contacted
several companies, but none of them, not even the Grocery
Manufacturers Association, would comment for this story.

For The Environment Report, I’m Julie Grant.

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Fda Says “Eat More Fish”

  • A catfish farmer in Mississippi (Photo by Stephen Ausmus, courtesy of the USDA)

The Food and Drug Administration
has once again opened the debate about
how much fish pregnant women can safely
eat. Lester Graham reports the FDA might
abandon guidelines it issued less than
five years ago:

Transcript

The Food and Drug Administration
has once again opened the debate about
how much fish pregnant women can safely
eat. Lester Graham reports the FDA might
abandon guidelines it issued less than
five years ago:

In early 2004 the FDA suggested pregnant women or women planning to become
pregnant should avoid fish with higher levels of mercury such as swordfish or shark.
And limit all other fish to a couple of meals a week.

Now, a proposed FDA recommendation indicates fish is too healthful to worry about
the mercury, and suggests instead of avoiding fish altogether, pregnant women
should eat more.

Sonya Lunder is with the advocacy organization, The Environmental Working Group.
She says the recommendation won’t hold up to scrutiny.

“And all the flaws in it will come to light. My concern is that the headlines that come
out that there’s a debate about the toxicity of fish or what pregnant women should
eat cause a lot of confusion.”

The FDA’s proposal comes after years of lobbying by the seafood industry.

For The Environment Report, this is Lester Graham.

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New Standards for Organic Fish

  • Farmed fish, such as salmon, eat a lot of wild fish that happen to swim into their pens. And that means they could be eating over-fished species. (Photo courtesy of the US Fish & Wildlife Service)

To be labeled organic, animals
have to be fed all organic food. But
under the new proposal that won’t be
the case for fish. Julie Grant reports
that in the recommendations for organic
fish, the standard is much lower:

Transcript

To be labeled organic, animals
have to be fed all organic food. But
under the new proposal that won’t be
the case for fish. Julie Grant reports
that in the recommendations for organic
fish, the standard is much lower:

Some fish is raised in huge net-pens in the ocean. Farmed
fish, such as salmon, eat a lot of wild fish that happen to
swim into their pens. And that means they could be eating
over-fished species.

New recommendations by the National Organic Standards
Board would go ahead and allow farmed fish to eat up to
25% wild food – as long as it’s not from endangered species.

George Leonard is director of aqua-culture with the Ocean
Conservancy. He says these standards would weaken the
organic label.

“You don’t change the organic standard to be consistent with
current practices, you hold the organic standard steady and
you allow or you incentive the industry to change their
practices to reach that standard.”

The new “organic fish” recommendations still need final
approval from the USDA.

For The Environment Report, I’m Julie Grant.

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Toxins in Antibacterial Soap Found in Fertilizer

An ingredient in many anti-bacterial soaps is ending up in fertilizer for food crops. The ingredient is toxic when ingested and scientists are worried it will migrate from the fertilizer into the food we eat. The GLRC’s Lester Graham reports:

Transcript

An ingredient in many anti-bacterial soaps is ending up in fertilizer for
food crops. The ingredient is toxic when ingested and scientists are
worried it will migrate from the fertilizer into the food we eat. The
GLRC’s Lester Graham reports:


The ingredient, triclocarban, is used in anti-bacterial soaps. It’s washed
down the drain and to the local sewer plant. Most of it is removed from
the wastewater before it flows back into rivers and lakes, but as reported
in the journal Environmental Science and Technology, researchers at
Johns Hopkins found triclocarban does not degrade in the wastewater
treatment and ends up concentrated in the sewer sludge. That sludge is
often hauled away and used as fertilizer for crops.


The researchers noted that the Food and Drug Administration has
determined that regular use of anti-bacterial soap is no more beneficial
than regular soap, but we keep using it.


The researchers say they’ll next test to see of triclocarban is migrating
from the fertilizer into the foods we eat and whether it poses a human
health risk.


For the GLRC, this is Lester Graham.

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Feds Want Control of Food Labeling

A bill that would pre-empt states’ rights to label food is making its way through Congress. Most of the states’ Attorneys General have signed a petition opposing the law. The GLRC’s Lester Graham reports:

Transcript

A bill that would pre-empt states’ rights to label food is making its way
through Congress. Most of the states’ Attorneys General have signed a
petition opposing the law. The GLRC’s Lester Graham reports:


The sponsor, Michigan Republican Mike Rogers, says the National
Uniformity for Food Act is an appropriate extension of national
standards protecting food. But if it becomes law it will prohibit states
from telling people about chemicals or additives approved by the FDA,
but likely to be of concern when you buy your groceries.


For example, in California any food that contains chemicals known to
cause cancer or birth defects is required to carry a label saying so.


Another additive – recently approved by the FDA – is carbon monoxide
to help keep the meat looking red. Labels warning about that would not
be allowed under the proposal.


37 state attorneys general have signed a petition opposing the law, saying
the states should be allowed to warn against such chemicals. Opponents
say the bill puts special interests in the food industry before public’s right
to know what’s in their food.


For the GLRC, this is Lester Graham.

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Legislation Dividing Organic, Biotech Farmers

  • Organic farms are concerned about nearby farms that produce genetically modified crops. They fear that the genetically modified crops will cross with and alter the genes of their own crops. (Photo by Rene Cerney)

The nation’s agricultural seed companies are fighting local restrictions on their genetically engineered products. They say it’s the federal government’s job to regulate food safety. But critics say federal agencies aren’t doing a good job of testing genetically modified food for safety. They’re backing the right of local governments to regulate genetically engineered crops themselves. The Great Lakes Radio Consortium’s Sarah Hulett reports:

Transcript

The nation’s agricultural seed companies are fighting local restrictions on
their genetically engineered products. They say it’s the federal
government’s job to regulate food safety, but critics say federal agencies
aren’t doing a good job of testing genetically modified food for safety.
They’re backing the right of local governments to regulate genetically
engineered crops themselves. The Great Lakes Radio Consortium’s
Sarah Hulett reports:


Genetically engineered crops are created when genes from other plants,
animals or bacteria are used to alter their DNA.


Critics call them “Franken-foods,” and two years ago, three California
counties banned farmers from growing genetically altered crops. That
alarmed the agribusiness industry, and now it’s fighting to keep that from
happening elsewhere.


So far, the industry successfully lobbied 14 states to pass laws preventing
their local governments from putting restrictions on engineered crops.
Four other states are considering similar measures.


Jim Byrum is with the Michigan Agri-Business Association.


“Frankly, it’s pretty frustrating for us to look at some of the rumors that
are floating around about what happens with new technology. It’s
reduced pesticide use; it’s reduced producer expense in production. It’s
done all sorts of things.”


Genetically engineered seeds are created in the laboratories of big seed
companies like Monsanto and DuPont. The modified plants can produce
higher-yield crops that make their own insecticides, or tolerate crop-
killing problems such as drought or viruses.


Proponents of the technology say genetically altered crops have the
potential to feed the world more efficiently, and they say it’s better for
the environment. That’s because the crops can be grown with fewer
polluting pesticides, but critics say not enough is known yet about
engineered crops’ long-term ecological impact, or on the health of
people who eat them.


(Sound of farm)


Michelle Lutz is among the skeptics. She and her husband run an 80-
acre organic farm north of Detroit. She’s watching about a dozen head of
the beef cattle she’s raising. They’re feeding on cobs of organic corn
grown several yards away.


“I’m surrounded by conventional farmers. The farmers right over here to
my east – they’re good people, and I don’t think they would intentionally
do anything to jeopardize me, but they are growing genetically modified
corn.”


Lutz worries that pollen from genetically modified corn from those
nearby fields could make its way to her corn plants – and contaminate
her crop by cross-breeding with it. Lutz says people buy produce from
her farm because they trust that it’s free from pesticides, because it’s
locally grown, and because it has not been genetically altered. She says
she shares her customers’ concerns about the safety of engineered foods.


Lutz says letting local governments create zones that don’t allow
genetically engineered crops would protect organic crops from
contamination.


But Jim Byrum of the Michigan Agri-Business Association says no
township or county should be allowed to stop farmers from growing
genetically modified crops. He says every engineered seed variety that’s
on the market is extensively tested by federal agencies.


“Frankly, that evaluation system exists at the federal level. There’s
nothing like that at the state level, and there’s certainly nothing like that
at the local level. We want to have decisions on new technology, new
seed, based on science as opposed to emotion.”


Critics say the federal government’s evaluation of genetically modified
crops is not much more than a rubber stamp. The FDA does not approve
the safety of these crops. That’s just wrong.


Doug Gurian-Sherman is a former advisor on food biotechnology for the
Food and Drug Administration.


“It’s a very cursory process. At the end of it, FDA says we recognize that
you, the company, has assured us that this crop is safe, and remind you
that it’s your responsibility to make sure that’s the case, and the data is
massaged – highly massaged – by the company. They decide what tests
to do, they decide how to do the tests. It’s not a rigorous process.”


Gurian-Sherman says local governments obviously don’t have the
resources to do their own safety testing of engineered foods, but he says
state lawmakers should not allow the future of food to be dictated by
powerful seed companies. He says local governments should be able to
protect their growers and food buyers from the inadequacies of federal
oversight.


For the GLRC, I’m Sarah Hulett.

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Maggots: Reviving an Ancient Medical Treatment

  • Maggots can be used as a medical treatment. Specifically, to help treat wounds. (Courtesy of the National Institutes of Health)

An ancient medical treatment is starting to be used again to treat wounds. But for many people, just the thought of the treatment is stomach-turning. The Great Lakes Radio Consortium’s Melissa Ingells has the story:

Transcript

An ancient medical treatment is starting to be used again to treat wounds,
but for many people, just the thought of the treatment is stomach turning.
The Great Lakes Radio Consortium’s Melissa Ingells has the story:


Ray Peterson has already lost one leg to diabetes. On his remaining foot
there’s a deep wound, and it’s not healing. It’s not getting better because
of the diabetes. He could lose his second leg.


His doctor is taking the dressing off Peterson’s wound. The wound…is
ugly. It looks like someone drilled a quarter-sized hole deep into
Peterson’s foot. The wound smells bad, and then the doctor finds
maggots. The blowfly larvae are squirming around in there. The doctor
is not surprised, though. He put the maggots there a few days ago. It’s
part of the treatment to save Ray Peterson’s leg.


They’re not exactly the kind of maggots you’d find in your garbage can,
but they’re similar. Last summer the FDA approved maggots as medical
devices.


The maggots eat the dead tissue, not the live flesh. In a process
researchers don’t completely understand… the maggots actually clean
and disinfect the wound much better than a surgeon could. Apparently,
they’re attracted to the bacteria in the dead tissue.


Ray Peterson is in his doctor’s office, trading in some big, full maggots
for some new hungry ones.


The old, fat maggots are washed off with saline. The doctor has to dig around
with the tweezers to get a few strays out.


Ray Peterson says he doesn’t mind seeing the process.


“I enjoy watching them, truthfully.”


The doctor cleans the wound a bit more and then places tiny, new maggots on
it with a small spatula.


(Sound of office)


There are plenty of maggot jokes as Dr. Dowling and the nurses work on
Peterson’s foot. Dowling says that his staff has become comfortable with
the maggots, but many health care professionals are not.


“Actually the patients react much better than the doctors. Every patient
I’ve done it on has been very excited and enthusiastic. I can’t say that’s
always the case for the medical community at large. I’ve had some
doctors tell patients if you have maggots on your foot, don’t come in my
office, but I think that will go away with time the more it’s accepted.


The new maggots start moving around as soon as they feel warmth and smell
food. Dr. Dowling and his nurses quickly contain them with a bandage.


“We build a cage around the wound to hold the maggots in, we’ll put the
maggots in, cover up the cage, and leave it there for two to three days,
and during that time the maggots will increase in size two to three times.
And then, when they come in we’ll take the cage off and wash the maggots out
with saline solution, and look at the wound and decide if it needs another
application or not.”


Several clinical studies have been conducted on the maggot treatment.
The results have been overwhelmingly good, but because the idea is so
repulsive to many patients or their doctors, the practice is still not
widespread.


Robert Root Bernstein is a professor of physiology at Michigan State
University. He co-wrote the book “Honey, Mud, Maggots and other Medical Marvels.”


“Taking a maggot or a bunch of maggots and putting them in a wound and watching
them crawl around in there is not something that most people find appealing, and
usually okay for the patient – the patient doesn’t actually have to look. It’s the
practitioners who have to deal with these squirmy little things and have to put
them in and take them out who seem to have most of the problem with the therapy.”


Root Bernstein says maggot therapy might catch on. That’s because doctors are seeing
more and more diabetic wounds as the rate of diabetes keeps going up in the U.S.
When medicines such as antibiotics don’t work on the stubborn wounds,
patients and doctors sometimes turn to the maggot therapy as their last hope for
recovery.


Ray Peterson found out about maggot therapy when his daughter saw an
article in a local newspaper. He says at first his friends were a little put
off, but then started kidding him about the procedure.


“They call me maggot man. Just for a joke. I go along with them. You’re a pretty
good sport about this. You gotta be.”


And Peterson says the good-natured ribbing is sure a lot better than the
alternative. Peterson also thinks if people can get past the “ick” factor…
more people’s limbs might be saved by maggot therapy.


For the GLRC, I’m Melissa Ingells.

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Genetically Modified Salmon on the Market?

A biotech company is hoping to cash in on a genetically modified salmon. If the F-D-A approves the fish, it would be the first transgenic animal species available for human consumption. The Great Lake Radio Consortium’s Nancy Cohen reports:

Transcript

A biotech company is hoping to cash in on a genetically modified
salmon. If the FDA approves the fish, it would be the first transgenic
animal species available for human consumption. The Great Lake Radio
Consortium’s Nancy Cohen reports:


Aquaculture firms are developing fish that are resistant to disease,
consume low-cost diets and grow faster. The Massachusetts-based Aqua
Bounty Technologies took part of the genetic code from a fish called the
ocean pout, and added it to the Atlantic salmon. The ocean pout’s
genetic material acts as a kind of switch that turns on the salmon’s
growth regulators.


Joe McGonigle is with Aqua Bounty. He says the result is a salmon that
grows twice as fast as other farmed salmon.


“You can get more heart healthy omega 3 protein on the market at a
lower price, you can produce fish more quickly, you can use fewer
resources and you can manage water quality and fish health, in a much
better way than under current conditions.”


But critics are concerned about the environmental impact on native fish
populations if genetically modified fish were to escape into the wild.


For the GLRC, I’m Nancy Cohen.

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Fda to Review Mercury in Canned Tuna

A newspaper investigation of mercury levels in canned tuna has prompted a probe by the U.S. Food and Drug Administration. The Great Lakes Radio Consortium’s Erin Toner reports:

Transcript

A newspaper investigation of mercury levels in canned tuna has
prompted a probe by the U.S. Food and Drug Administration. The Great
Lakes Radio Consortium’s Erin Toner reports:


Last year the FDA updated its mercury warning. It said that canned light
tuna is low in mercury. Now, in response to a Chicago Tribune series,
the agency says it will take a closer look at mercury levels.


The newspaper reported the tuna industry is using yellowfin – a
potentially high-mercury species – to make about 15 percent of the light
tuna sold every year. The Tribune reported varying levels of mercury in
light tuna products, and that most cans containing yellowfin tuna are not
labeled as such.


Environmental groups have demanded tougher restrictions on mercury in
tuna and more specific labeling requirements so people know what
they’re eating.


A lobbyist for top tuna producers has said light tuna is not a health risk,
but said the industry would cooperate with the FDA investigation.


High levels of mercury can cause neurological and learning problems in
children.


For the GLRC, I’m Erin Toner.

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Ten Threats: Mercury and Health Problems

  • Fish advisories warn about possible mercury contamination, but many people aren't aware of the risks. (Photo by Lester Graham)

There’s no disputing that fish is healthful food, but too much of certain
kinds of fish can be dangerous, especially if you’re a woman planning to
have children. That’s because some fish contain elevated levels of
mercury. Mercury is a toxic contaminant that can cause neurological
damage. Julie Halpert filed this report about the harms mercury can
cause:

Transcript

We’re continuing our series ‘Ten Threats to the Great Lakes.’ One of the
threats identified by experts was air pollution that in turn pollutes the
lakes. The Great Lakes Radio Consortium’s Lester Graham is our guide
in this series. He says the next report looks at one pollutant that
eventually affects people.


There’s no disputing that fish is healthful food, but too much of certain
kinds of fish can be dangerous, especially if you’re a woman planning to
have children. That’s because some fish contain elevated levels of
mercury. Mercury is a toxic contaminant that can cause neurological
damage. Julie Halpert filed this report about the harms mercury can
cause:


Three years ago, when she was 18, Ayla Brown was healthy, but
suddenly, she started getting sick all the time. She was always tired, she
became anemic and had sore throats. Her tonsils had deteriorated so
much that they had to be removed. Her doctor couldn’t figure out why,
so he decided to test her for heavy metals poisoning.


The result? Ayla’s mercury levels were off the charts. They were five
times higher than the normal level. Her entire family was tested and
their levels also were above normal.


“The only conclusion we could come to is that in the past year or so since
we had moved to Ann Arbor, we had started eating a lot of fish and a lot
of fish that we now know is very known to be high in mercury, such as
swordfish and tuna and stuff like that.”


The Browns ate several meals of fish every week. Some of it was
ocean fish. Some of it was Great Lakes fish. After the diagnosis, they
cut fish out of their diet altogether. Within a year, the mercury levels
returned to normal.


“You are trying so hard to eat healthy and my family always was very
health conscious and so it’s so frustrating when you’ve done something
that you thought was good for you and realize that it was completely the
wrong thing.”


Fish are generally considered part of a healthy diet, but not all fish are
entirely safe. That’s because of mercury. Mercury exists naturally in the
environment at low levels, but higher amounts are getting into the food
chain.


Coal-burning power plants emit mercury, which eventually settles into
the Great Lakes. Then, aquatic microorganisms convert the substance
into methyl mercury, which is more toxic.


Those microorganisms form the base of the food chain. Small fish eat
microorganisms. Then, larger fish eat the smaller ones. As that happens,
the mercury concentrations escalate, making big large mouth fish like
trout, salmon and some walleye especially contaminated.


When people eat the fish, the mercury is passed on to them. Women of
childbearing age and their fetuses are most at risk.


Michael Carvan is with the University of Wisconsin-Milwaukee’s Great
Lakes Water Institute. He says the exposure isn’t just from the fish that
women eat while they’re pregnant. A woman can pass her entire lifetime
load of mercury to her baby. He says that 15% of all women of
childbearing age have high enough levels so that their fetuses will
contain mercury of one part per million or higher.


“Even at really low levels, around one part per million, you’re talking
about some subtle coordination difficulties, you’re talking about
problems with memory and problems with neuro-processing and IQ
deficits.”


Because of these concerns, the Environmental Protection Agency and
the Food and Drug Administration issued an advisory for women of
childbearing age and children, suggesting they eat fish and shellfish only
twice a week.


But one expert is concerned by all this talk about how mercury harms
people. John Dellinger was on a task force, which provided guidance on
fish consumption advisories. Dellinger studied people who lived on
Lake Superior who he thought would eat a lot of fish, but he found
something else.


“We basically discovered that from an epidemiologic point of view, these
populations have other things that are adversely affecting their health,
that in fact will probably overshadow anything we’re going to see from
the contaminants in their fish.”


Dellinger said the people were so concerned about contaminants in
fish, that they started relying on store-bought, processed food instead.
Those foods were higher in fat and sugar and contained other, less
healthful, ingredients. So, obesity and diabetes caused health problems,
not mercury poisoning, and Dellinger says that ended up being a worse
situation.


He says the key is to choose wisely, avoiding fish such as swordfish,
tuna steaks and the larger predator Great Lakes fish that are high in
mercury. That’s the only measure you can take right now, but that doesn’t
solve the problem. The real challenge will be to get rid of the mercury
that ends up contaminating the fish.


For the GLRC, I’m Julie Halpert.

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