Nanoparticles: A Tiny Question of Safety

Revolution Without Regulation

How do you get the ketchup to slide easily out of the bottle? Nanoparticles. They're the miracle technology we're using in everything from sunscreen to paint. But how much do we really know about nanotechnology and its potential impact on our health?

BY ALEX ROSLIN
August 11, 2012

THE MONTREAL GAZETTE

If you have Robert Schiestl over to your house, don’t be surprised to see him peeking at ingredient labels on things in your kitchen or bathroom.

He can’t help it. Schiestl, a leading U.S. cancer expert, instinctively reads the label before he buys or uses a host of products — any food that’s partly white, toothpaste, sunscreen, shampoo, over-the-counter medicine.

He’s trying to avoid nanoparticles, which a growing pile of studies say may cause cancer, damage to organs and skin, Crohn’s disease and environmental pollution.

Labels in Canada and the U.S. don’t have to say whether a product contains nanoparticles — so to be completely sure, Schiestl avoids all products with two ingredients that are increasingly used in nano-form: titanium dioxide and zinc oxide.

The tiny particles causing the concern are as little as 10,000 times the width of a human hair and are measured in nanometres, or billionths of a metre.

They’re part of a revolutionary technology that’s been touted as “the most powerful tool the human species has ever used” — giving us the ability to build anything we can conceive molecule by molecule, and potentially leading to healthier lives and cleaner energy.

Governments, eager to get on the nanotechnology bandwagon, have shovelled huge public subsidies into nanotech in the past decade, fuelling its growth into a $250-billion-per-year global industry that is expected to grow to $3 trillion by 2015.

The subsidies have helped promote the use of nanoparticles in thousands of goods — everything from food colouring to scratch-resistant coating on eyeglasses and anti-bacterial agent in clothes.

Nanotech has even answered the age-old problem of getting ketchup out of the bottle. In 2007, German scientists developed a super-slippery nano-coating for bottles that lets ketchup slide out more easily.

Yet, more than a decade after nanoparticles started being widely used in consumer products, they are still subject to virtually no regulation in Canada, and little is known about their health impacts....

[Read the rest of this story here. Also see "How Nanoparticles Are Made?" and "Sweets, Sunscreen, Toothpaste: Labels Tell Only Part of the Story."]

Nuclear Fishin'

[This story was nominated for a Canadian Association of Journalists award for investigative reporting and by the Western Magazine Awards for a prize in the environment category. -AR]

Japanese tests have revealed high radiation levels in some Pacific Ocean seafood, creating concern among doctors at B.C. universities

by Alex Roslin
The Georgia Straight
July 19, 2012

Are fish from the Pacific Ocean and Japanese coastal and inland waters safe to eat 16 months after the Fukushima nuclear disaster?

Governments and many scientists say they are. But the largest collection of data on radiation in Japanese fish tells a very different story.

In June, 56 percent of Japanese fish catches tested by the Japanese government were contaminated with cesium-137 and -134. (Both are human-made radioactive isotopes—produced through nuclear fission—of the element cesium.)

And 9.3 percent of the catches exceeded Japan’s official ceiling for cesium, which is 100 becquerels per kilogram (Bq/kg). (A becquerel is a unit of radioactivity equal to one nuclear disintegration per second.)

Radiation levels remain especially high in many species that Japan has exported to Canada in recent years, such as cod, sole, halibut, landlocked kokanee, carp, trout, and eel.

Of these species, cod, sole, and halibut, which are oceanic species, could also be fished by other nations that export their Pacific Ocean catch to Canada.

The revelations come from the Japanese Fisheries Agency’s radiation tests on almost 14,000 commercial fish catches in both international Pacific and Japanese waters since March 11, 2011, when an earthquake and tsunami triggered multiple meltdowns at the Fukushima Daiichi Nuclear Power Plant.

The wrecked plant spewed enormous amounts of radiation into the Pacific, where cesium levels near the Fukushima coast shot up to an astonishing 45 million times the pre-accident levels.

Japan’s Fisheries Agency data is easily the most comprehensive on Fukushima’s radioactive impacts on the Pacific Ocean, home to the world’s biggest fishery and a major food source for more than a billion people.

The numbers show that far from dissipating with time, as government officials and scientists in Canada and elsewhere claimed they would, levels of radiation from Fukushima have stayed stubbornly high in fish. In June 2012, the average contaminated fish catch had 65 becquerels of cesium per kilo. That’s much higher than the average of five Bq/kg found in the days after the accident back in March 2011, before cesium from Fukushima had spread widely through the region’s food chain.

In some species, radiation levels are actually higher this year than last.

...

[Read the rest of this story here and the original version on the Georgia Straight's website here.]

The Meat of the Matter

Insiders say Canada's meat-inspection system isn't keeping consumers safe from food-borne illnesses.

by Alex Roslin

The Georgia Straight

October 21, 2010

[This story won the Canadian Association of Journalists award for best investigative reporting in a Canadian magazine in 2010. See the Georgia Straight site's version of the story here.]

At the end of a gravel road 20 kilometres east of Fort St. John, Arlene Laughren’s house used to be her little piece of heaven.

Now it’s like a prison.

Laughren moved here six years ago with her husband, Keith Holmes, to raise horses, llamas, sheep, and chickens and to grow vegetables on a 66-hectare hobby farm amid the picturesque coulees, hills, and ravines by the Peace River.

Now most of the animals are gone and her garden is overgrown with tall weeds. Laughren, 53, is stuck at home while her husband is away at work. She has brain damage, memory loss, and poor balance. She can no longer drive and hasn’t worked in more than two years—ever since she got two brain abscesses after eating a bad ham sandwich.

It was July 2008 when Laughren ate the ham produced by Maple Leaf Foods while at the Fort St. John hospital. She was getting treatment related to Crohn’s disease, which she has had since childhood. Her medication suppressed her immune system and made her more vulnerable to the Listeria monocytogenes bacteria on the ham.

Four days after the fateful meal, violent headaches started and she began to feel dizzy. After two falls, hospital staff gave her a CAT scan and saw something abnormal in her brain. Laughren was flown by air ambulance to Vancouver, where she had brain surgery. Doctors traced the abscesses to the ham, and she was diagnosed with the bacterial infection listeriosis. She remained in a Vancouver hospital for five months of treatment, followed by six weeks of rehabilitation.

Two years later, Laughren says doctors told her she will never work again. She used to counsel youth with difficulties at the Fort St. John high school. “I really miss them,” she says.

Laughren was one of hundreds of Canadians sickened—many with gastroenteritis—in the 2008 Maple Leaf listeria outbreak, which caused 57 confirmed cases of listeriosis. Twenty-three died, including one in B.C., and many, like Laughren, suffered permanent disabilities. A government inquiry into the fiasco placed much of the blame on numerous shortcomings in the government’s food-safety system.

The Canadian Food Inspection Agency was especially singled out. The so-called Weatherill inquiry said it didn’t have enough meat inspectors and was poorly managed. For four years, inspectors had failed to do all of the required audits of the Toronto Maple Leaf plant that produced the tainted meat. The inquiry made 57 recommendations for improvements.

But more than a year later, food scientists and the CFIA’s own meat inspectors say that most of the recommendations have yet to be adopted and that Canada’s food supply may not be safer than before.

If anything, they say the level of inspection of deli meats—the kind involved in the Maple Leaf episode—may actually have declined. Meanwhile, the numbers of food poisonings and recalls are rising. And new, controversial methods of producing meat are increasing the risk of food-borne illnesses even more while raising other questions about the meat on our plates.

“The rates of listeria recalls in recent years are amazing. It’s one after the other. The rates are going up; recalls are going up. Something is fundamentally wrong,” says Kevin Allen, an assistant professor of food microbiology at the University of British Columbia.

“It’s safe to say some of the sanitation methods are not working as they should,” he says in a phone interview from his office. “There is a lack of control in the food-production process.”

Since the 2004 fiscal year, Canada has seen a steady rise in the number of meat and poultry recalls each year, according to data provided by the CFIA (which would not grant an interview to the Georgia Straight). The number has more than doubled, from 44 in 2004 to 91 in 2008. B.C. has been especially hard hit by food recalls. It experienced 605 recalls of all types of food, including meat and poultry, between 2004 and 2008—or 26 percent of the national total. Yet B.C. has only 13 percent of Canada’s population.

And because most food-borne illnesses never come to the government’s attention, the reported cases represent just a tiny fraction of all the food poisonings—only one out of every 300 to 350 actual cases, according to the Maple Leaf inquiry. In fact, food-borne illnesses sicken a whopping 11 to 13 million Canadians each year, according to the Public Health Agency of Canada, and as many as 500 may die as a result.

Why are food poisonings skyrocketing? Bob Kingston has a good idea why: a hobbled meat-inspection system that’s a shadow of its former self and that struggles to keep up with the fast-changing food industry. If anything, he says, meat inspectors are even more taxed now than before the Maple Leaf disaster.

Kingston worked for almost 30 years as a federal quarantine inspector in Burnaby before becoming president of the 9,500-member Agriculture Union, which includes federal meat inspectors. Earlier this year, his union gave Canada’s food-safety system a failing grade for heeding so few of the Maple Leaf inquiry’s recommendations.

“You’re up to five or six plants per inspector. I know inspectors who have told me they are responsible for 10 plants. If they actually want enforcement, it’s way over the top,” he says.

“All you have time to do is glance at the paperwork, see if it’s fine, and race to the next plant. If you have to do an enforcement action, good luck finding time to do it.”

The problem comes down to time. It takes about 800 hours (or 20 weeks of full-time work) to meet inspection requirements for a single processed-meat plant, according to union estimates. That doesn’t include hundreds of additional hours needed for certifying imports and exports, plus leave or vacation time.

“I feel for the inspectors,” says UBC’s Allen. “Many are faced with an unruly workload. They’re really taxed right now.”

According to the Weatherill inquiry, government inspectors assigned to the Toronto Maple Leaf plant “appear to have been stressed due to their responsibilities at other plants”. In September 2009, with a possible federal election looming, Ottawa promised to hire 70 new meat inspectors to fill shortfalls identified in the inquiry. A year later, only 40 of the new positions have been filled. Much of the money for the new hires was simply taken out of other CFIA operations, Kingston says; penny-pinching at the agency is so tight that it has cancelled training initiatives and some offices have no money for pens or paper.

Even our neighbours are taking notice. Last year, the U.S. Department of Agriculture told Canada it wasn’t meeting U.S. standards for inspecting processed meat destined for export south of the border. It demanded that Canadian meat inspectors check up on exporting plants once every 12 hours, as U.S. standards require.

Canada increased the level of checks to that standard. Meanwhile, plants making processed meat for Canadians are inspected at the far more leisurely pace of only once a week. The CFIA says inspectors spend more time during each of their weekly inspections of the plants with Canadian-destined meat, so the total amount of inspection time is the same as for U.S.–destined meat.

Kingston says this is “highly unlikely”. He notes that the CFIA would have needed the equivalent of 50 extra full-time inspectors to meet the greater frequency of USDA-mandated inspections. If the level of inspection was really the same, he says, no new hires would have been needed.

He also says plants visited more often tend to have better safety records. “If an inspector comes once a day, a plant behaves totally differently than when they know the inspector is coming only once a week,” he says.

Because there is little money for the new hires, the extra USDA-mandated inspections have resulted in astronomical levels of overtime for the CFIA’s existing 260 processed-meat inspectors, Kingston says. The additional burden means many inspectors are now faced with an even greater workload than before 2008, he says.

It wasn’t always like this. The food-safety system and meat industry have both undergone a sea change since 1981, when Kingston became a union rep for federal agriculture department employees, including meat inspectors. (He moved to the CFIA when it was created in 1997.)

In the 1980s, beef was usually butchered by hand in a large number of small meat-processing plants spread across the country. Each one had a federal meat inspector assigned to oversee it full-time. Mechanization of slaughterhouse operations and processing started to transform the industry in the late 1980s and 1990s. Machines run by low-wage operators started to replace trained butchers. The small plants were consolidated into fewer, large operations—some on a massive scale. One plant in Alberta processes 2,000 beef carcasses in a single day. Another in Manitoba goes through 10,000 pigs daily.

The machines might be more efficient, but they’re also less able than a human hand to butcher an animal in a way that avoids contaminating it with bacteria-laden feces, Kingston says. Also, when there was a bacteria outbreak at one of the smaller plants, it was usually pretty limited in scope. “Now if you do half a day’s run [of tainted product] out of one of these big plants, you’ve contaminated half the continent,” Kingston says.

These were also the lean years of Brian Mulroney’s budget cutbacks and deregulation. Ottawa was only too happy to acquiesce to industry demands to reduce the burden of meat inspection. Inspectors now found themselves responsible for several facilities each, as opposed to one, even as the plants ballooned in size.

At the same time, inspectors got go-easy marching orders. Previously, when inspectors saw a problem—like unsanitary conditions—they’d pull the plug on operations or slow production until the issue was fixed.

Starting in 2005, the federal government took the deregulation a step further by quietly implementing a new food-safety system that shifted much of the burden of policing to the meat industry. Instead of shutting down a dirty facility, inspectors were instructed to issue a “corrective action request”. A meat processor would now usually have 14 days to respond with an explanation of how it would deal with the issue—and would, in most cases, have another 60 days to implement changes. Companies can request time extensions past the initial 60 days. They are routinely granted, Kingston says.

An inspector who shuts down a meat plant today “would probably be disciplined unless he has approval from five levels of management. He would be accused of being overzealous,” Kingston says.

The new meat-inspection regimen was slammed in the Maple Leaf inquiry, which said it was plagued by a shortage of inspectors, poor planning, mismanagement, and lack of training for supervisors. The Weatherill inquiry called on the CFIA to audit its new system; it is not clear if that audit is still under way.

At the same time as Canada deregulated meat production, other innovations were altering the very composition of the meat we eat and creating new challenges for food safety. One of the greatest changes was finding a profitable new use for fatty layers at the outer surfaces of a cow carcass, known in the industry as “bench trim”.

Once used mostly for pet food and cooking oil, the fatty trimmings are now widely used in hamburger in Canada and the U.S. The trimmings are combined with leaner cuts from many different cows, frequently from various countries, the New York Times reported in an October 2009 investigation. Author Eric Schlosser (Fast Food Nation) wrote in Rolling Stone back in 1998 that one U.S. fast-food burger patty may contain meat from 40 to 100 different cows raised in as many as six different countries.

The low-grade cuts are more susceptible to E. coli bacterial contamination because they come from parts of the cow that are more likely to come into contact with feces. Trimmings were at the centre of controversy in the U.S. last year after illness outbreaks linked to tainted hamburger. The outbreaks prompted U.S. authorities to tighten inspection of bench trim.

More controversy has surrounded “meat glue”. The “glue” is a natural protein derived from cow or pig blood. It allows meat processors to stick together various lumps of meat into a regular-looking steak, roast, or kebab. In the meat business, it’s known as “restructured beef”.

Canada allows the product to be sold here, but the European parliament rejected it for sale in the EU in May because of concerns that artificial steaks could mislead the public. “Consumers in Europe should be able to trust that they are buying a real steak or ham, not pieces of meat that have been glued together,” Jo Lienen, chair of the parliament’s environment committee, said during debate on the issue.

The glue also raises food-safety issues, says Keith Warriner, an associate professor of food science at the University of Guelph, in a phone interview from his office. If there is a bacteria outbreak, it’s much harder to figure out the source when chunks of meat from multiple cows were combined.

Also, the products need to be fully cooked, like ground beef, to kill bacteria. A regular steak is safe to eat medium-rare because only its surface has bacteria. But when different cuts of meat are blended together, the product may have contaminated surfaces on the inside, and it has to be cooked to an internal temperature of 71 ° C (160 ° F). This, Warriner says, could lead to confusion among consumers used to cooking their steaks medium-rare (63 ° C, or 145 ° F).

Yet another innovation is “modified atmosphere packaging”, the widespread practice of filling meat packaging with adjusted levels of oxygen and other gases. The gases can keep meat from losing its fresh-looking red hue. Shiv Chopra, an Ottawa food-safety expert and retired Health Canada scientist, said in an e-mail that the technique is “dangerous” because it may prevent shoppers from seeing when meat has gone bad. UBC’s Allen agreed: “This can be misleading to consumers.”

It all adds up to huge challenges for a tattered food-safety system. Kingston predicts more Maple Leaf–type incidents. “It’s inevitable that more of this comes along if nothing changes.”

Back at her home outside Fort St. John, Laughren is disheartened. “The one thing I thought would come from this is they would improve food safety. But I don’t think there has been much of anything done.”

She gazes longingly at the horse saddle hanging on a saddle rack in her living room. She used to ride in amateur competitions, but now she doesn’t have enough coordination to ride a horse. She is still waiting to receive part of a $27-million payout that Maple Leaf agreed to make last year to settle several class-action lawsuits related to the listeria outbreak. With thousands of claimants expected, the processing of claims has been a time-consuming task.

Meanwhile, the Canada Revenue Agency is hounding her husband for writing off his stay in Vancouver while he helped Laughren recover from her brain surgery. Despite a doctor’s letter saying her husband’s presence “was imperative for her treatment”, the taxman nixed the write-off and is demanding back taxes.

“You just expect the government to be watching our backs. But that’s silly,” Laughren says.

Her memory loss means she sometimes forgets things like friends’ names and her phone number, but there’s one thing she always remembers: her decision to never eat processed meat again.

The Clones On Our Plates

Is food from cloned animals safe to eat? The debate continues, but some of the meat and milk is already making its way into the marketplace in the U.S. - and possibly Canada.

by Alex Roslin

The Montreal Gazette

Saturday, September 06, 2008

Clones. To some, the word evokes Frankenfood or Star Wars Stormtroopers. To veterinarian Donald Coover, it conjures a miraculous world of super-cows with high milk and meat yields and horses as fast as Secretariat, the legendary Triple Crown-winning thoroughbred.

Coover is helping to lead the clone revolution out of tiny Galesburg, Kansas, a village of 150 with one convenience store and two churches, surrounded by fields of wheat and cattle ranches.

This is the home base of Coover's company SEK Genetics and its thriving business of selling semen from elite cows to farmers. He says he has also sold enough semen from cloned cows to inseminate tens of thousands of farm animals, and he says "dozens at least, hundreds probably" of other cloning businesses in the U.S. are doing the same thing.

Despite a request by the U.S. Department of Agriculture that farmers respect a voluntary moratorium on selling food from clones to consumers, Coover says he has sold dozens of clones and their offspring to farmers for use in food production since 2001.

"It's not illegal, and it's not unethical," he said. "Instead of having just another damn horse, you have Secretariat every time. That is why it's enormously useful." Cloning is a way to create a perfect genetic copy of an adult animal. Its cell material is transferred to an egg that is grown into an embryo and implanted in a surrogate mother.

Advocates like Coover say the process can help farmers duplicate top livestock and improve meat and milk yields.

"It's frustrating to me that we've been able to develop this incredible technology, and people are bitching and moaning about it," he said.

Food from clones is still banned in Canada, but Health Canada is now considering whether to lift the ban.

Surveys show widespread public unease about the technology. In a 2003 survey for the Canadian government, only 24 per cent of Canadians and 32 per cent of Americans supported the use of cloned animals for food.

The most common concern was "long-term risk to human health," cited by 37 per cent of Canadians.

After a seven-year scientific review, the U.S. Food and Drug Administration last January okayed meat and milk from cloned cows, pigs and goats and their offspring as being safe to eat.

The selling of clone food to consumers is still on hold while the U.S. Department of Agriculture works out a plan to assuage the concerns of consumers in the U.S. and abroad. In the interim, it has asked cloners and livestock farmers to continue to respect its voluntary moratorium.

"The food in every respect is indistinguishable from food from any other animal," FDA official Stephen Sundlof told reporters last January.

But the scientific debate about clone food still appears far from over. In fact, Sundlof's statement seems to be contradicted by a 2006 background paper on cloning prepared by the Canadian Food Inspection Agency that was obtained through an access-to-information request.

The CFIA paper and the FDA's own 968-page scientific review published last January depict cloning as an unpredictable technology fraught with problems that almost always leads to outright failure or disfigured animals that aren't safe to eat.

Even in cases where clones and their offspring look healthy, they appear to suffer from genetic abnormalities and research is sparse on whether their food is safe, the documents say.

"There is not enough data to indicate there will be no problem," said Pascale Chavatte-Palmer, one of the world's leading cloning researchers, whose studies are cited over 50 times in the FDA report.

"I think we should know more. We feel there is a rush to accept those clones," she said in an interview.

In Europe, food from clones isn't being sold because of formal and informal moratoriums in various countries. But this week, the European Parliament voted 622-to-32 to urge the European Union's executive branch to ban food from clones, citing concerns about food safety, consumer confidence and animal suffering.

The move followed a report from the European Food Safety Authority in July that said, while there is "no clear evidence" food from cloned cows and pigs is unsafe, more study is needed because of the lack of data.

***

Chavatte-Palmer is no anti-biotech Luddite. She's dined on what she calls "very good" cloned Kobe beef, which she thinks was most likely safe to eat. Yet, she paints a picture of a technology that's about as precise as a steamroller.

Out of 1,000 attempts, a clone embryo is successfully developed and implanted into a surrogate mother only about 100 times, said Chavatte-Palmer, who is a research leader at the French government's Institut Nationale de la Recherche Agronomique, the leading agricultural-research institute in Europe.

Of those 100 embryo transfers, just five fetuses are typically born alive, she said.

The rest mostly miscarry due to genetic or physical defects or abnormal placentas. Their most common abnormality is called large offspring syndrome, which results in fetuses 20- to 85-per-cent larger than average.

The animals that survive to birth also often have large offspring syndrome - which occurs in up to half of clone births - or other severe problems like a deformed head, contracted tendons, extreme diarrhea, diabetes, respiratory failure, heart disease and kidney problems. Many die shortly after birth.

A Japanese study cited in the FDA's review painted an unsettling picture of several clone calves that had died. "The neck was bent backwards, the hind legs were stretched tightly or the second joints were bent toward the opposite direction from the normal position," it said.

"Calf No. 12 was disemboweled at parturition and the face of calf 16 was warped."

Some of the calves had been born with "an 'adult' appearance" and displayed "many wrinkles in the skin, thick bone structure and rough hairs resembling those of adult males."

Indeed, Dolly the sheep, the first mammal cloned from an adult cell in 1996, lived for only six years, half the average lifespan for her breed, and developed obesity, lung cancer and premature arthritis.

Even the few clones that appear to be healthy really aren't, said Chavatte-Palmer, who is one of a small handful of scientists worldwide to have studied the long-term health of clones.

"Cloned animals, although apparently normal, are however significantly different from (conventionally raised animals) maintained in the same conditions," she wrote in a paper in the journal Animal last year.

The CFIA came to a similar conclusion in its paper. "There is an inadequate amount of information on any species to determine long-term physiological effects (of cloning)," it said.

"Early research suggests that these animals have subtle gene expression abnormalities."

The CFIA said cloning "could have long-term effects that compromise animal health and survival."

***

So is food from clones safe to eat? The FDA's review concluded that meat and milk from deformed clones, which die early in life or need to be euthanized, is unsafe.

But in a little-noticed passage deep in its report, the agency okayed this food for entry into the human food chain if it is treated in a meat-rendering plant.

Rendering plants process dead animals from zoos and shelters, old meat from grocery stores and butcher-shop trimmings by chopping them up, then cooking them at high temperatures.

Rendering leads to several products that enter the human food chain directly and indirectly, including lard, tallow, protein for livestock feed and crop fertilizer.

The FDA report cites no research on whether or not rendered food from abnormal clones is safe.

"There is not a single study of that," said Jaydee Hanson, a policy analyst at the Washington, D.C.-based Centre for Food Safety.

Hanson said it can't be assumed the rendering process makes all animal products safe to eat. "They don't let animals with mad cow disease enter the food supply through rendering," he said. "They have a belief this is safe. Belief is wonderful for a religious organization."

As for healthy-looking clones, the FDA says their food is identical to that from other animals. "These products are not different than food from traditionally bred animals," Bruce Knight, a senior U.S. Department of Agriculture official, told reporters last January.

But the CFIA paper and the FDA's own review raise questions about this conclusion as well.

"The use of (cloning) may have an effect on gene expression in the resulting animals and thus alter food characteristics, such as biochemical composition, which may be a food safety concern," the CFIA paper says.

"Stress-related developmental problems in young clones may also present an indirect food safety concern. This may lead to increased usage of antimicrobials for the treatment of such disease-prone clones and could also have an effect on the shedding of antimicrobial-resistant bacteria."

The FDA's review acknowledges no large-scale studies of the meat and milk of clones have been done. It relies on 10 small-scale studies involving an average of just five clones each.

Five of the 10 studies found statistically significant differences between food from clones and conventionally bred animals.

Chavatte-Palmer did one of those five studies. She found cow clones reached puberty an average of 62 days later than normal animals, which she said "probably will affect the quality (of their meat) ... The full maturation of muscle is delayed in clones."

As well, she found milk from cow clones had different levels of some fatty acids and enzymes than milk from conventional animals. She concluded more research is needed on whether the differences could cause food allergies.

For pork, the FDA cited only two studies involving seven clones in total, both done by biotech company ViaGen. They found the clones grew 30-per-cent slower than normal animals and had less meat. Two of the clones had so many health problems their data wasn't even included in the final results. The FDA questioned the study because of the small number of clones.

No studies have been done at all on food from goats, the third clone species that the FDA okayed.

***

For all the talk about clones, the fact is we're actually unlikely to ever see a clone T-bone at the butcher shop. That's because clones are up to 10 times more expensive to produce than conventional animals - $10,000 to $16,000 for a cow and $6,000 for a pig.

The main source of clone-derived food is likely to be naturally bred offspring of clones. The FDA says clone offspring have fewer health problems than clones and are identical to normal animals.

But the CFIA background paper says there is "limited" data on food from clone offspring and cited two major U.S. reviews of the issue that expressed concern about the "inconclusive evidence" about the safety of their food.

The FDA's report cited no studies on meat or milk from the offspring of cows or goats and only two studies on pork from the offspring of pig clones. The clone offspring were mostly the same as conventional animals, but like the clones had several differences: Of 58 nutrients tested, clone offspring meat had significantly less of seven nutrients, while more of two others. It was also somewhat fattier, more acidic and shrunk more during cooking - indications of poorer quality.

There is also little longer-term research about the health of offspring as they age.

The FDA review says the offspring seem to be healthier than their clone parents because their genetic errors are "reset."

But one of the scientists the FDA cites in its review says he disagrees with the agency's conclusion.

Dean Betts, an associate professor of biomedical sciences at the University of Guelph, is one of the few scientists to have looked into the health of clone offspring.

Betts found the offspring of goat and sheep clones have genetic abnormalities - significantly shorter telomeres, which are the chromosome endings that are believed to control aging and susceptibility to cancer.

Shorter telomere lengths could explain why many clones seem to age faster than normal animals. Dolly the sheep was also found to have shorter telomeres.

"We don't know what it means or if it has health impacts," Betts said. "I would say not enough study has been done ... There could be some impacts on the species itself over generations."

In France, Chavatte-Palmer had hopes of getting some definitive answers to the questions about the health and food of clones and their offspring. But her cloning work has ground virtually to a halt. Funding has dried up, she says, because cloning is a sensitive issue for grant-funding agencies.

"We have piles of data that we haven't had time and money to get help to analyze," she said. "It's very difficult to get funding in this area of research. It's frustrating, very frustrating."

SIDEBAR

Are we already dining on clones?

No labels on clone food in U.S., FDA says

Canadians may have been consuming food from clones for years without knowing it, despite a Health Canada ban.

That’s one of the surprising revelations from documents on cloning from the Canadian Food Inspection Agency obtained under the access-to-information legislation.

About 800 cloned dairy cattle produced through an early version of cloning called embryonic-cell nuclear transfer and from embryo splitting have been registered in Canada since the 1980s, said a CFIA background paper on cloning written in 2006.

The CFIA paper said food from these clones can be sold to Canadian consumers. “There is generally no restriction on the marketing of products, by-products or the progeny of animal clones that are produced using the embryo-splitting technique in Canada or elsewhere,” it said.

The CFIA paper didn’t say whether milk from the cloned cows was indeed sold to consumers. An agency spokesperson didn’t respond to a request for comment.

Health Canada, however, says no food from clones, including embryonic-cell nuclear-transfer clones, can be sold in the country. “It shouldn’t be on the market,” said Paul Duchesne, a department spokesman.

Embryonic-cell nuclear-transfer was used in the 1980s and early 1990s but was replaced in the mid-1990s by an improved technique called somatic-cell nuclear-transfer cloning, which replicates an adult animal, instead of an embryo.

Donald Coover, a Kansas veterinarian who says he has sold clones and their semen to farmers in the U.S. for years, said hundreds of embryonic-cell nuclear-transfer clones were produced in the U.S. and that their meat and milk quietly entered the U.S. food supply without any official safety review.

He said it’s very likely the same thing happened in Canada. “Nobody at the time made a big deal about it.”

And now that the U.S. Food and Drug Administration has okayed clone food for human consumption, the CFIA again seems to have no plan for keeping it out of the country, according to an internal email sent by a manager at the agency.

“CFIA has no specific regulatory controls for animal clones,” said the email, dated Feb. 14, a month after the FDA’s decision last January. “There are no special tracking provisions.”

The issue of tracking food from clones is complicated by the fact that the FDA has decided not to label the food, and there’s no way to test if a particular animal is a clone.

“All we’ve had are some preliminary discussions on… the feasibility of detection,” said a CFIA official, who spoke off the record because she is not authorized to talk with journalists. “Nothing has been put in place, and no policies have been created around that.”

SIDEBAR

Quebec farmers shrug off cloning—it’s too costly

Quebec farmers don’t seem to be rushing to embrace cloning. The Union des Producteurs Agricoles, representing 44,000 Quebec farmers, says it has no position on whether to embrace food from clones.

“We haven’t discussed it very much,” said spokesman Patrice Juneau. “It’s not a very important issue for us.”

The 3,800-member Fédération des producteurs de porcs du Québec, also has no position, said spokeswoman Nathalie Hansen.

“The steps required to produce a live (clone) animal are almost a nightmare for farm applications,” said Roger Sauvé, a cow veterinarian in St. Louis de Gonzague, 45 kilometres southwest of Montreal, who specializes in reproductive services for farmers.

“It’s very, very expensive to produce cloned animals right now. Farmers are not ready to pay that kind of money. Practically, it doesn’t make sense.”

Sauvé said existing reproductive technologies are more efficient and cheaper and also offer the advantage of improving a herd’s genetics if two top animals are bred together, while clones can only be as good as their progenitors.

For more information:

- The FDA's Jan. 2008 risk assessment of food from clones and their offspring

- European Parliament reports on cloning

- The Center for Food Safety’s report on food from clones

Clone, Clone On the Range

French researcher Pascale Chavatte-Palmer (above) says there is a rush to accept cloned farm animals and not enough funding available for necessary research.

By Alex Roslin
February 21, 2008
The Georgia Straight
[read the original story]

Since many cloned farm animals are born with abnormalities, how safe is their meat and milk?

When the U.S. Food and Drug Administration announced in January that food from cloned farm animals was safe to eat, the agency said the science was clear. Officials said meat and milk from cloned cows, pigs, and goats are exactly the same as conventional food.

“The food in every respect is indistinguishable from food from any other animal so it is beyond our imagination to even find a theory that would cause the food to be unsafe,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, told reporters at a news conference in Washington,D.C.

In her office outside Paris, one of the world’s leading cloning researchers, Pascale Chavatte-Palmer, didn’t think the research was clear at all. Working out of the French government’s National Institute for Agricultural Research, she helps supervise one of only two or three noncorporate research facilities worldwide studying the long-term health of—and food products from—large numbers of cloned animals.

Chavatte-Palmer, a group research leader at the INRA, has found milk and meat from cloned cows are, indeed, different. “The full maturation of muscle is delayed in clones,” she said over the phone from her office 25 kilometres southwest of Paris. “This probably will affect the quality [of the meat]. It will certainly be a bit different.”

And those aren’t the only differences she’s found between clones and normal animals. In a series of papers she has coauthored in leading scientific journals, Chavatte-Palmer has reported that clones of cows reached puberty 62 days later, on average, than normal animals and they were 56 kilograms heavier when they did so. And then there were the huge numbers of clones that didn’t make it that far.

At an INRA farm whose exact location Chavatte-Palmer can’t disclose for security reasons, she has helped produce some of the world’s most comprehensive research on what happens when we try to clone farm animals. Her studies are cited 54 times in the FDA’s mammoth 968-page risk assessment on food from clones.

The idea of cloning is to create a perfect genetic copy of an adult animal by taking the nucleus from one of its cells and transferring it into an egg that has no nucleus. In about 100 of 1,000 cases, the egg develops into an embryo that can then be implanted in a surrogate mother.

Of those 100 embryo transfers, the INRA research found more than 50 fetuses spontaneously abort in the first trimester of pregnancy because of genetic or physical anomalies or defects in the placenta—a rate two times higher than for conventionally bred cows.

Another 20 or so abort later in pregnancy, most often because of a grotesque ailment sometimes called large offspring syndrome, which results in a fetus 20 to 85 percent larger than average.

In the end, fewer than five of the fetuses, on average, are born alive, Chavatte-Palmer reported in a 2004 paper in the journal Cloning and Stem Cells. This finding is in line with a European Food Safety Authority draft scientific opinion on cloning released in December 2007 that said the success rate for clone fetuses reaching term is 0.5 percent to five percent.

The FDA risk assessment offers a similarly glum, if a tad less dismal, cloning success rate of five percent to 18 percent.

But making it into the world alive is just the beginning of the struggle for many clones. Many are born with limb and head deformities, contracted tendons, extreme diarrhea, diabetes, respiratory failure, heart disease, and kidney problems.

Contrary to the sunny views of FDA officials at the Washington news conference, the agency’s risk assessment makes for sombre reading about the unpredictable science of cloning. It cites one 2000 Japanese study that painted an especially unsettling picture: “Calves [numbered] 11, 13-15, 20 and 22 died at parturition [birth] or several days later and had significant morphological abnormalities of the kidney or cacomelia [limb deformity]; the neck was bent backwards, the hind legs were stretched tightly or the second joints were bent toward the opposite direction from the normal position…

“Calf number 12 was disemboweled at parturition and the face of calf 16 was warped and the second joints of both hind legs were bent in the opposite direction from the normal position.”

This study, published in the Journal of Reproduction and Fertility, also reported on the bizarre appearance of many clone calves at birth, which “had an ‘adult’ appearance” and displayed “many wrinkles in the skin, thick bone structure, and rough hairs resembling those of adult males”.

Some of these postnatal complications are, again, caused by large offspring syndrome, which occurs in 14 percent to 50 percent of successful clone births, compared to 9.5 percent of animals produced by in vitro fertilization.

As for older clones, virtually no research on their health and longevity has been done, even though it’s been 12 years since Dolly the sheep—the first mammal cloned from an adult cell—was born in 1996. Dolly herself had to be euthanized at the young age of six after developing arthritis and lung disease.

The FDA is quite frank about most of these problems in its risk assessment. “Many questions have been raised regarding the immune function of clones and their ability to resist or recover from disease, yet few studies have examined this issue directly in bovine clones,” it says.

So how can the FDA still okay food from clones? The reasoning goes like this: yes, almost all cloning attempts fail, and, yes, there is evidence the animals that do survive are genetically abnormal. But the FDA says it hasn’t been shown that such genetic abnormalities make food from clones unsafe. “The relevance of ‘epigenetic normality’ to food consumption risks is unclear,” its report notes.

So the FDA concludes that as long as clones are pronounced to be physically healthy by a food inspector, their meat and milk are safe to eat.

The logic baffles Jaydee Hanson, a policy analyst at the Washington, D.C.–based Center for Food Safety. “They have no data. The standard way to assess something like this is to do long-term studies of feeding it [cloned-animal products] to animals,” he said, speaking on the phone from his office.

“The [FDA’s] basic assumption is if an animal can walk in the door of a slaughterhouse, it’s safe to eat. I don’t know what slaughterhouses they visited. There are tremendous problems in slaughterhouses about whether we’re packaging meat we shouldn’t.”

But beyond that, it’s still an open question whether or not any clones are really healthy. The FDA acknowledges as much. Its report cites a 2004 paper in the New England Journal of Medicine by cloning pioneer Rudolf Jaenisch, the MIT biologist who created the first genetically engineered animals in the 1970s.

He wrote: “Gene-expression analyses indicate that four to five percent of the overall genome and 30 to 50 percent of imprinted genes are not correctly expressed in tissues of newborn cloned mice. These data represent strong molecular evidence that cloned animals, even if they survive to birth, have serious gene-expression abnormalities.”

In France, Chavatte-Palmer concluded in a paper last year in the journal Animal: “Cloned animals, although apparently normal, are however significantly different from contemporary controls maintained in the same conditions.”

It also turns out there’s no solid evidence for saying the meat and milk of clones really are the same as those from conventionally bred animals. No large-scale studies have been done. “Information on the composition of meat or milk from animal clones has been limited,” the FDA’s report says.

The agency explored the idea of sending some clone food for lab tests but dropped the plan because, apparently, it didn’t have access to enough sample material for a statistically valid result.

Instead, the FDA relied on several small-scale studies of meat and milk composition involving an average of five clones each. Five of the 10 studies found differences between food from clones and conventionally bred animals.

One study coauthored by Chavatte-Palmer last year in the journal Theriogenology reported statistically significant differences in vital fatty acids and enzymes in milk from clones compared to conventional animals.

Of five studies of cow meat, two—including Chavatte-Palmer’s Theriogenology paper—found significant differences in fat content, proteins, fatty acids, and enzymes between beef from clones and that from conventionally bred cows. For pork, only two studies were cited involving five clones in total, both from biotech company ViaGen. They found the clones had less back-fat thickness and meat yield than control animals, plus their meat was darker and redder.

No studies have been done at all on food from goats, the third clone species that the FDA okayed for food production.

Apart from these 10 studies, the FDA cited three others that also showed differences in clone meat or milk, but the reason may have been the varying diet of the animals.

These less-than-stellar results went unmentioned when U.S. officials spoke to reporters in January about the decision to okay clone food. “These products are not different than food from traditionally bred animals,” said Bruce Knight, the agriculture department’s undersecretary for marketing and regulatory programs, at the news conference. He described cloning as just “another breeding technique” that “has now been demonstrated to be safe”.

Chavatte-Palmer thinks more study is still needed. She’s no anti-biotech advocate, and she personally believes that meat and milk from clones are probably safe to eat. But she added: “I think we should know more. Our study is one of the biggest published, but it’s still limited. There is not enough data to indicate there will be no problem. We feel there is a rush to accept those clones.”

Food from cloned animals could officially enter the U.S. food supply starting as soon as a few months. The short delay is because of a temporary voluntary moratorium suggested to the industry by the U.S. Department of Agriculture—time to work out a plan to assuage the concerns of consumers in the U.S. and abroad.

The moratorium would be extended at least another year by a farm bill that the U.S. Senate passed in December requiring an outside study by the National Academy of Sciences of the safety of food from clones and impacts on human health. That bill is now the subject of negotiations with the House to reconcile different versions.

If the moratorium is lifted, clone food seems likely to slip largely unnoticed into American grocery stores without much possibility of being tracked. That’s thanks in part to the FDA’s decision not to require labels on the food or any tracking mechanism for cloned animals and their offspring.

There’s also a practical reason the food will be virtually impossible to track: there’s no way to test whether an animal is cloned or had a clone ancestor. “The answer is no,” said the FDA’s Sundlof when a reporter at the January news conference asked if such a test is possible. “These animals are indistinguishable; both the animal and any food produced from those animals is absolutely indistinguishable from any other food source.”

And despite the voluntary moratorium, food from clones has already been entering the U.S. marketplace for about 20 years, according to Donald Coover, a Galesburg, Kansas, veterinarian and owner of SEK Genetics, which retails cow semen to farmers. Coover said he himself has sold U.S. ranchers several dozen clone offspring as well as “thousands of units of semen” from clones. He put the number of other U.S. cloning businesses flouting the ban at “dozens at least, hundreds probably”.

“It’s not illegal and it’s not unethical,” said Coover, reached on his cellphone at the Iowa Beef Expo. “Instead of having just another damn horse, you have Secretariat every time. That is why it’s enormously useful.”

Coover said food from clones first entered American diets in the 1980s and early 1990s from an initial generation of clones made with split embryos. This was long before Dolly, who was cloned from an adult cell. The earlier clones didn’t catch on with ranchers because it was a crapshoot trying to predict if an embryo would turn into a superior animal as an adult.

Nonetheless, Coover said hundreds of split-embryo clones were produced, and their meat and milk quietly entered the U.S. food supply without any formal assessment of the products’ safety. “I’m not aware of any large-scale studies,” said Coover. “It just was not considered as a health or nutrition issue by the FDA.”

FDA spokesperson Brad Swezey refused comment, saying in an e-mail: “We aren’t doing interviews on cloning.”

Coover said it’s very possible some offspring of split-embryo clones also entered Canada’s food supply. “I would be stunned [if that wasn’t the case]. I can tell you for certain there was nobody up there looking at this.”

In Canada, food from both adult and split-embryo clones is banned by order of Health Canada. The Canadian Food Inspection Agency, which enforces the ban and monitors food imports, didn’t respond to a request for comment on Coover’s claim or how it plans to stop clones from entering the country.

Health Canada is now studying the FDA risk assessment as part of a reevaluation of the Canadian policy on food from clones.

For all the attention on food from clones, the fact is you’ll never see a clone T-bone at your butcher. That’s because clones are up to 10 times more expensive to produce than conventional animals—$10,000 to $16,000 for a cow and $6,000 for a pig. Instead, most clone food in our diets would not come directly from clones themselves.

Remember all those abnormal clones that are euthanized or die prematurely? You didn’t think they’d go to waste, did you? The FDA says their meat is unsafe to eat. However, its risk assessment says an acceptable disposal method would be to send the carcasses to rendering plants, where they would get chopped up and cooked with spoiled meat from grocery stores, dead animals from zoos and shelters and butcher-shop trimmings, then turned into pet food and human food products like lard.

The FDA cites no research on whether or not rendered food from abnormal clones is safe. “There is not a single study of that,” says Jaydee Hanson, of the Center for Food Safety. “They don’t let animals with mad-cow disease enter the food supply through rendering.”

The other big source of clone-
derived food would be the naturally bred offspring of clones. “Everything in those tissues is the same as what you’re seeing with our natural conceived animals,” Bernadette Dunham, director of the FDA Center for Veterinary Medicine, told reporters in January.

But again, the FDA acknowledges in its assessment that the science is limited on the health of clone offspring or the composition of their meat and milk. The FDA risk assessment cites only two studies on pork from the offspring of pig clones—one of them from biotech company ViaGen. They found the clone offspring had less fatty acids, shorter back and loin lengths, and less bacon yield. No studies at all were cited on beef or milk from the offspring of clones. A few studies have found clone progeny tend to be born with fewer abnormalities than their parents, but there is little longer-term research on offspring as they age.

Nonetheless, the FDA concludes that any genetic errors in clones are likely “reset” in their offspring. Because of the lack of research on offspring of livestock clones, the agency cites evidence from the so-called mouse model: research on mice that suggests offspring of clones benefit from some kind of genetic reset button.

“We don’t have enough data to say that is 100-percent true,” Chavatte-Palmer said. “The mouse model has been shown not to be a good model for humans. I don’t see why it would be a good model for cows. The best model for cows would be cows.”

One of the few scientists who has looked into the health of clone offspring is Dean Betts, an associate professor of biomedical sciences at the University of Guelph in Ontario. Betts coauthored a pair of studies in the journal Molecular Reproduction and Development in 2005 and 2007 that found sheep and goat clones and their offspring have significantly shorter telomeres, the chromosome endings believed to control aging and susceptibility to cancer.

“It [the telomere] provides chromosomal stability. Without it, you have a greater chance of genomic instability, which leads to cancer,” Betts said in an interview from his office at the university.

Shorter telomere lengths could explain why many clones seem to age faster than normal animals. Dolly the sheep, for one, was found to have shorter telomeres. “Do they [the offspring of clones] have a possibility of shorter life spans and age-related diseases?” Betts asked. “We don’t know what it means or if it has health impacts. I would say not enough study has been done…There could be some impacts on the species itself over generations.”

Asked if he agrees with the FDA’s assertion that genetic errors are probably reset in the offspring of clones, Betts said: “Based on my study, I wouldn’t support that statement. My study would say the opposite, that they are not reset.”

Back in France, Chavatte-Palmer had high hopes she could get some answers about the health, longevity, and food of clones and their offspring. But her cloning work has ground virtually to a halt. She said grant-funding agencies have turned down most of INRA’s proposals to study the facility’s 70 clones and offspring—one of only two or three such large groups of animals at a noncorporate facility anywhere in the world.

Now money has run out to maintain a group of normal animals in similar conditions as the clones—necessary in order to have a good comparison sample, Chavatte-Palmer said.

“We have piles of data that we haven’t had time and money to get help to analyze…It’s very difficult to get funding in this area of research. Europe doesn’t want to hear about it, even though we are told it [clone food] is safe. It’s frustrating, very frustrating. I’m thinking at some point it’s best to move on to something else.”