Cloning: Agribusiness as Usual

• Apart from the under-researched 'safety' of cloning, and its inherent cruelty to animals, this technology serves only corporate, not consumer interests
  By Peter Melchett
  The Guardian - UK, January 16, 2008
  
  
  

To no one's great surprise, the US Food and Drug Administration has decided that cloned animals, and products from them, such as milk, are safe for consumers.

As a result, European regulators are now under pressure to adopt the same pro-cloning policy in order to allow imports of foods from cloned animals, and indeed that is supported by the EU's scientific advisory committee. Already, thousands of doses of cattle semen from clones have been used in the US. In September last year, the European Commission held a meeting to help it decide on its policy. Experts explained how cloning depends on several horribly cruel processes. Using hormones and invasive techniques, the eggs are extracted from female animals, and surrogate mothers are then used to rear the implanted embryos. There are frequent abnormalities and many foetuses are naturally aborted or have to be terminated. Many others die soon after birth.

Partly because of these huge losses, the clones themselves are extremely expensive, and would not be used for food, but they would be used, for example, for producing semen for artificial insemination.

US regulators have decided that the progeny of cloned animals can be used for food, despite the fact that there is almost no scientific research to show if this is safe. The Soil Association, along with almost all of those involved with organic food, and many others, is concerned about these further attempts to manipulate nature in ways that will benefit a few of the largest farmers and enrich some of the largest agribusiness companies in the world.

My own concerns fall into two main areas - risk and animal welfare. Food safety cannot and should not be judged until there is a body of scientific understanding of the biological impacts of cloning. With so little research into the health impacts, it is unscientific and totally irresponsible to simply "assume" or "hope" that these animals are safe for eating. This approach has been proven to be wrong with GM; many animal trials show negative effects from "EU approved" GM crops.

There are major animal welfare problems, which mean this technique should not be allowed even if it is "safe" for people. The commercial use of cloning, for example through artificial insemination, will further reduce the genetic diversity of livestock and so increase the risk of disease epidemics. More generally, this technique will promote industrialisation of livestock rearing with negative nutritional, animal health and environmental consequences, including increased emissions of greenhouse gases.

Whatever your view on the lack of scientific evidence for food safety, the animal welfare arguments against cloning on animal welfare grounds seem to me to be irresistible. The scientists involved in cloning claim that the "loss rates" are coming down as the technology improves. Joyce D'Silva, of Compassion in World Farming, is clear that this technology is unacceptable on animal welfare grounds. She notes that cloned animals "are the high-producing animals that have the most endemic welfare problems anyway".

Those supporting cloning respond to the animal welfare criticisms in exactly the same way as the GM industry has responded to the realities of higher pesticide use, similar or lower yields, and rejection in the marketplace - by promising jam tomorrow. In the case of cloning, scientists claim that cloning could be used to enhance animal welfare - for example, by spreading useful genetic mutations that make animals resistant to diseases such as scrapie. The same scientists claim that cloning could make animals able to adapt to a changing climate or to resist new diseases. There is no evidence that any of this can actually be achieved, any more than GM crops have eradicated hunger and starvation nearly a quarter of a century after GM scientists started claiming that these miracles would soon be delivered by GM technology.

In an interesting quote, the UK's National Farmers Union (NFU), which represents agribusiness, and currently takes a pro-GM and pro-cloning line, reveals what is wrong about the reaction of some farmers to these new technologies. Helen Ferrier, the NFU's food science adviser, says: "Generally, our views on the safety or the acceptability etc are really based on the opinions of independent scientific experts." It's one thing to rely on scientists to pronounce on safety, but why on earth aren't the NFU listening to their customers when it comes to deciding whether a particular way of raising farm animals is "acceptable" or not? Whether something is acceptable is a moral question, something which people producing a product should leave to society as a whole and individual customers to decide. It is a gross abuse of science to suggest that pronouncing on acceptability is a scientific matter.

To add insult to injury, the NFU go on to say that they don't want there to be any requirement to label meat or dairy products from cloned animals or their offspring because it might "mislead" consumers. So the animals suffer and the people who buy the food from these new and cruel systems are going to be kept in the dark about where their food comes from. I suppose, as an organic farmer, working in a system that bans GM and cloning, I should be pleased; but, in fact, the whole business leaves me feeling sickened and sad.

The clones are coming

http://www.lobbywatch.org/archive2.asp?arcid=8833

EXTRACT:

Secretly videotaped footage by the Humane Society of America showing cows too sick to walk being forklifted, shocked, and dragged to the slaughterhouse has led to the largest beef recall in American history: 143 million pounds, 37 million of which went to school lunch programs. Although the recall only pertains to meat packaged by California-based Westland/Hallmark Meat Company over the past two years, the USDA openly admits that most of the recalled meat has already been eaten - fortunately without incident.

What's ironic, however, is that if we're so concerned about the health risks associated with eating sick or abnormal animals, why on earth has the FDA approved meat produced by cloning - a method known for producing significant abnormalities - for human consumption? The Center for Food Safety notes:

Most cloned animals born on a farm, outside a veterinary hospital, have little chance of surviving. Those animals that manage to survive until birth are likely to suffer a wide range of health defects and deformities including: enlarged tongues; squashed faces; intestinal blockages; immune deficiencies; diabetes; high rates of heart and lung damage; kidney failure; and brain abnormalities

Or, as Rudolph Jaenisch of the Whitehead Institute has noted, 'cloned animals have major dysregulation of multiple genes, so they are not normal at all.' Sound tasty, eh? Let's just hope that it doesn't take the USDA two years to figure out that it's probably not the best idea to eat this stuff.

FDA Opens "Pandora's Box" by Approving Food from Clones for Sale

Contact:
Joseph Mendelson, Center for Food Safety (202) 547-9359 or (703) 244-1724; Jaydee Hanson, Center for Food Safety (202) 547-9359 or (703) 231-5956; John Bianchi, Goodman Media International: (212) 576-2700, x228

(January 15, 2008) Washington, DC - Today, the Center for Food Safety (CFS) condemned the Food and Drug Administration's (FDA) irresponsible determination that milk and meat from cloned animals are safe for sale to the public. In addition, the FDA is requiring no tracking system for clones or labeling of products produced from clones or their offspring. This action comes at a time when the U.S. Senate has voted twice to delay FDA's decision on cloned animals until additional safety and economic studies can be completed by the National Academy of Sciences and the United States Department of Agriculture (USDA).

"The FDA's bullheaded action today disregards the will of the public and the Senate - and opens a literal Pandora's Box," said Andrew Kimbrell, CFS Executive Director. "FDA based their decision on an incomplete and flawed review that relies on studies supplied by cloning companies that want to force cloning technology on American consumers. FDA's action has placed the interests of a handful of biotech firms above those of the public they are charged with protecting."

With FDA's release of their controversial risk assessment today, CFS joins dozens of other food industry, consumer, and animal welfare groups, as well as federal lawmakers in calling for swift action on the part of Congress to pass the 2007 Farm Bill containing provisions delaying FDA's release of clones into the food supply. The Farm Bill currently contains an amendment, advanced by Senator Barbara A. Mikulski (D-MD.) and co-sponsored by Senator Arlen Specter (R-PA), requiring a rigorous and careful review of the human health and economic impacts of allowing cloned food into America's food supply. The Senate overwhelmingly passed the bill by a vote of 79 to 14.

"The passage of this bill with the Mikulski-Specter amendment sends a strong message that the FDA has failed the public again by taking an inadequate and half-baked look at the safety of food products from cloned animals and their offspring," said Joseph Mendelson, CFS Legal Director. "The FDA's cavalier approach to cloned food and its potential impacts calls for the remedy of a truly rigorous scientific assessment, and Congress has now repeatedly called for such action."

The Farm Bill amendment addresses the gaps and inadequacies of the FDAs current risk assessment, and would go into effect before any food products from clones are marketed. The Farm Bill also directs the USDA to examine consumer acceptance of cloned foods and the likely impacts they could have on domestic and international markets. (Click here for more information on this amendment).

Additionally, the FDA is today issuing a guidance document for food producers; It fails to require any special procedures for tracking or handling food products from clones. It also fails to require labeling of any kind on food products from clones or their offspring, which deprives consumers of their right to know about the origins of their food.

Recently, two cloning companies - Viagen and Trans Ova, proposed the creation of a voluntary cloning registry program. While they advanced claims that the registry would provide consumer protection and transparency without regulation, clones and their progeny will still be dispersed through the food system without any tracking or labeling.

"The cloning industry's proposal is simply another attempt to force cloned milk and meat on consumers and the dairy industry by giving the public phony assurances," said Mendelson. "The proposal neither provides new studies on the safety of clones nor protects the consumers' right to know whether their food or dairy contains products from clones. Once clones are released into America's food supply without any traceability requirements, it will be difficult, if not impossible, to recall them."

Recent opinion polls show the majority of Americans do not want milk or meat from cloned animals in their food. A December 2006 poll by the Pew Initiative on Food and Biotechnology found that nearly two-thirds of U.S. consumers were uncomfortable with animal cloning. A national survey conducted this year by Consumers Union found that 89 percent of Americans want to see cloned foods labeled, while 69 percent said that they have concerns about cloned meat and dairy products in the food supply. A recent Gallup Poll reported that more than 60 percent of Americans believe that it is immoral to clone animals, while the Pew Initiative on Food and Biotechnology found that a similar percentage say that, despite FDA approval, they won't buy milk from cloned animals.

In its risk assessment of cloned food, the FDA claims to have evaluated extensive peer reviewed safety studies to support its conclusion, yet a recent report issued by CFS, Not Ready for Prime Time, shows the assessment only references three peer-reviewed food safety studies, all of which focus on the narrow issue of milk from cloned cows. What is even more disturbing is that these studies were partially funded by the same biotech firms that produce clones for profit.

Read the executive summary of the Center for Food Safety's report Not Ready for Prime Time

Read the full CFS report.

View FDA's documents released January 15th

Christmas clones

American Anti-Vivisection Society ♦ Center for Food Safety

Consumer Federation of America ♦ Consumers Union

Farm Sanctuary ♦ Food & Water Watch

Humane Society of the United States

Contact: Joe Mendelson, Center for Food Safety, 703-244-1724

John Bianchi, Goodman Media, 212-576-2700

Tracie Letterman, Esq, American Anti-Vivisection Society, 215-887-0816

Chris Waldrop, Consumer Federation of America, 202-797-8551

Julie Janovsky, Farm Sanctuary, 301 654 2903

Michael Greger, M.D., The Humane Society of the United States, 202-676-2361

Michael Hansen, PhD, Consumers Union, 917-774-3801.

Consumers May Receive Unwelcome Gift This Holiday Season

Coalition Condemns Food and Drug Administration Plans for Cloned Foods as Irresponsible,

Calls on FDA to Respect Will of Congress and Maintain Cloning Moratorium

December 18, 2007— This holiday season, people have more to fear than the dreaded fruitcake. Advocacy and watchdog groups are putting consumers on alert. The meat and dairy products they buy may soon come from cloned animals, and they will not even know it. The Food and Drug Administration (FDA) has completed its analysis on cloning, which means that an announcement could come by the end of this month that animals can be cloned and sold for food, and without labels.

"Surveys have repeatedly shown that consumers are wary of food from cloned animals," said Chris Waldrop, Director of the Food Policy Institute at the Consumer Federation of America. "We need a much more comprehensive assessment of the potential implications of allowing food from cloned animals into the food supply." The impacts on U.S. agriculture, trade, and the integrity of the food supply are still largely unknown. Unlabeled products from cloned animals in the food supply could have significant repercussions.

The U.S. Congress shares the groups' concerns. Just last week, the Senate passed the Farm Bill (H.R. 2419) with a provision introduced by Senators Barbara Mikulski (D-MD) and Arlen Specter (R-PA) requiring the FDA to delay its decision on cloned animals until additional studies can be completed by the USDA and the National Academy of Sciences (NAS). The House-Senate conference is expected to decide on the provisions of the final Farm Bill in early 2008.

"With Friday's passage of the Farm Bill, the Senate has sent the FDA an unequivocal message; the public wants more information before clones are released into the food supply," said Center for Food Safety Legal Director Joe Mendelson. "The prudent approach outlined in the Mikulski-Specter Amendment calls for thorough and peer reviewed testing before any green light is given to cloned food. American consumers deserve no less than the best recommendations based on the most exhaustive scientific review."

"The FDA risk assessment ignored the fact that most clones never make it to adulthood because they die in gestation or shortly after birth, and also failed to consider whether clones might need more drug treatments," said Dr. Michael Hansen, Senior Scientist, Consumers Union. "We agree with the Senate that the NAS should take another look at the safety questions."

In addition, the House has passed the Consolidated Appropriations Act with language that strongly encourages the FDA to maintain the voluntary moratorium on cloned foods and directs the agency to complete a study with the USDA investigating the economic and trade implications of introducing cloned animals into the food supply. The Senate is expected to pass the Act later this week.

"There is broad bipartisan support for this cloning legislation," said Tracie Letterman, Executive Director of the American Anti-Vivisection Society. "Congress is clearly telling the FDA to wait on animal cloning because more information is needed about human health, animal welfare, and economic impacts. The FDA should respect that."

Opposition to the FDA's plans has also united an unlikely set of allies. Consumer and animal advocacy organizations, environmental groups, and the dairy industry have all urged the FDA to wait for further study before allowing food from cloned animals.

"It is much too soon for this controversial technology to be unleashed in the marketplace, especially without requiring it to be labeled," said Wenonah Hauter, Executive Director of Food & Water Watch. "When it comes to cloned food, the FDA should listen to the public instead of the biotech industry."

Opinion polls show that the vast majority of Americans do not want food from clones and are opposed to cloning for health, food safety, moral, and ethical reasons. The FDA received over 150,000 comments expressing outrage over its plans to allow animal cloning for food products.

"Animal protection advocates support scientific advancement, but cloning lacks any legitimate social value and decreases animal welfare in a dramatic way," said Wayne Pacelle, president and CEO of The Humane Society of the United States. "Congress has signaled that FDA needs to slow down the application of this bad idea, and we hope the agency will terminate the plan entirely."

Much of the concern stems from the fact that over 95 percent of cloning attempts fail, resulting in diseased and deformed animals, and the long-term health effects of consuming the "successful" clones are unknown. Many leading U.S. producers have already rejected using cloned animals.

"With the public increasingly concerned about the treatment of farm animals," said Julie Janovsky, Campaign Director for Farm Sanctuary, "the cloning legislation acknowledges the fact that cloning may lead to even harsher conditions for animals used to produce food".

Food from cloned animals - a bait and switch?
Osagie K. Obasogie & Pete Shanks
San Francisco Chronicle, 5 October 2007
http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2007/10/05/EDAOSK7VF.DTL&type=politics

Osagie K. Obasogie directs the project on Bioethics, Law, and Society at the Center for Genetics and Society in Oakland (www.genetics-and-society.org) and writes for the blog Biopolitical Times (www.biopoliticaltimes.org). Pete Shanks, a writer living in Santa Cruz, is the author of Human Genetic Engineering: A Guide for Activists, Skeptics, and the Very Perplexed (Nation Books, 2005).

Californians should be allowed to know what they're eating. That's the simple reason why Gov. Arnold Schwarzenegger should sign SB63, the nation’s first law requiring food from cloned animals to be labeled. But there are other reasons to go slow on this unproven technology, some of which have not received the attention they deserve.

Meat and milk from cloned animals are not yet available. But the Food and Drug Administration is about to allow them into America's food chain, contrary to both scientific evidence and public sentiment. The FDA issued a draft risk assessment in December 2006 that suggested food from cloned animals presents no serious safety issues. But this was discredited by a March 2007 report by the Center for Food Safety that exposed embarrassing inadequacies in the FDA's review; there are no peer-reviewed safety studies on meat from cloned cows, pigs or goats and only three inconclusive ones on milk. Even the National Academies of Science - the government's science adviser - has said that it's just not possible to adequately assess this foods' safety.

People find food from cloned animals rather unappetizing. A December 2006 Pew poll showed that nearly half of all people think it's unsafe while another 36 pecent are unsure. Not surprisingly, the FDA received well over 100,000 public comments that were overwhelmingly opposed to their rosy-eyed assessment.

What's more, food from cloned animals is probably not even commercially viable. Cloning is expensive and unreliable; according to a recent survey, the livestock industry views its commercial prospects as 'low' or 'medium to low.' So, how did we get to the point where California needs a law to protect its food supply from the federal agency charged with ensuring food safety? The push for producing food from cloned farm animals comes largely from one small sector of the biotech industry, not from meat and dairy producers. Two companies - Cyagra and ViaGen - provided data that fills more than a quarter of the FDA's 678-page report. These companies are not impartial experts; they are for-profits with a stake in the FDA's approval. And their track record is less than stellar. Cyagra is a spin-off from Advanced Cell Technology, a struggling biotech company that is infamous for science-by-press-release: causing a splash by exaggerating claims and hoping rebuttals get less attention. ViaGen is part of the Exeter Life Science Group owned by billionaire John Sperling, who also founded the now defunct pet-cloning operation Genetic Savings and Clone.

These companies' narrow economic interests are obvious. But why is the Biotechnology Industry Organization (BIO) - the industry's lobbying arm - supporting them when the vast majority of its members will not directly benefit? This partly comes from their central creed: science is a commodity to be sold without restrictions. Even when BIO agrees that some limits are appropriate - such as disallowing human reproductive cloning - they advocate self-regulation over public oversight.

Perhaps less obvious is the full extent of the industry's push to genetically manipulate living organisms. Agribusiness has adopted genetically modified crops, and worked hard to suppress attempts at labeling these unpopular products. But food isn’t the only thing on the agenda. For instance, more than 20 percent of human genes are privately owned through patents, affecting such things as when and at what cost women can find out if they have a genetic predisposition to breast cancer. Such patents have drawn much criticism, but the industry seems determined to push forward.

What's happening here is that food from cloned animals might pave the road for a bait and switch: the more cloned products that reach the market, the more likely it is that the public will accept other questionable biotech applications aimed literally right at them. And that is a road that could lead in directions most people reject, such as designer babies with genetically tailored attributes. If cloning became as much a part of daily life as the meat we eat and the milk we pour in our coffee, wouldn't it become easier to imagine applying similar technologies to enhance ourselves?

The bill that is on the governor's desk does not ban milk or meat from cloned livestock; all it stipulates is that these products have labels. That's more than reasonable. SB63 is a small step in the right direction and might help slow this issue long enough for the country to have the thorough debate it needs. The public interest demands a far deeper assessment of these technologies' impacts, both in themselves and in their future implications.

CFS report on clones

NEW REPORT SAYS FDA PLAN TO APPROVE SALE OF FOOD FROM ANIMAL CLONES IS BASED ON WISHFUL THINKING, NOT SCIENCE

Center for Food Safety Reveals that Milk and Meat from Clones is Untested and May Pose Health Risks to Consumers

Washington, DC (March 21, 2007) - The Center for Food Safety today issued a report critical of the Food and Drug Administration’s recent risk assessment on animal clones. The Center's review reveals that the risk assessment (which claims to show the safety of cloned food) relies almost entirely on unsupported assumptions and is based "more on faith than science." The Center is calling on FDA to issue a mandatory ban on the use of clones in food production until long-term studies demonstrate the safety of these foods and the vitally important ethical and animal welfare issues in cloning are resolved.

The Center's report "Not Ready for Prime Time: FDA's Flawed Approach to Assessing the Safety of Food from Animal Clones", was released today during a public comment period on FDA's planned approval of food from animal clones that is slated to close on April 2. The Center and numerous other organizations have requested an extension of the comment period to give Americans adequate time to review the Agency's findings and make their views heard. Public comments can be sent to FDA through the Center's website www.centerforfoodsafety.org.

The FDA says that food from clones is safe, and while they claim this view is supported by strong science, the Center for Food Safety Report actually shows that FDA found virtually no scientific studies to support the commercial release of these experimental foods. For example:

* FDA found no peer-reviewed studies on meat from cloned cows or on milk or meat from the offspring of cow clones.
* FDA found no peer-reviewed studies on meat from cloned pigs or their offspring.
* FDA found no peer-reviewed studies on meat or milk from cloned goats or their offspring.
* FDA found just three peer-reviewed studies on milk from cloned cows; all three studies showed differences in milk from clones that should have prompted further research.

"FDA's flawed approach falls far short of providing the kind of rigorous scientific assessment that Americans deserve before these experimental animals are allowed into the food supply," said Andrew Kimbrell, Executive Director of the Center.

The report further finds that the FDA's risk assessment is based on flawed assumptions and misrepresented findings. A summary of the report, which is attached, shows that:

1. Despite FDA's claim that there is “no difference” between food from clones and their progeny and food from naturally-bred animals, most of the studies they reviewed found troubling abnormalities and defects in animal clones which could pose food safety risks.

2. Evidence from the Agency's own report and from other scientists shows that cloning does not produce identical "twins" and that cloning therefore may not be useful in breeding. In fact, studies have found that clones from the same parent differ significantly from each other and from their parent animal. A recent scientific study concluded that scientists and breeders agree that cloning may not be useful for livestock production.

3. The FDA review contradicts itself, first claiming that genetically defective clones will pose no risk to the food supply because the sick animals will be detected and removed, but then admitting that some sick and defective clones may in fact end up as food.

4. FDA says the defects seen in clones also occur in natural reproduction, differing only by degree in clones, but the Agency also finds several defects in clones that are rarely or never seen in normal animals. For example, one common abnormality in clones that can result in stillbirth or early death - or death of the mother – occurs in normal cows only once in 7,500 instances, while it may occur in up to 42% of cloned cows.

5. While the FDA claims that improvement in cloning technology is resulting in better success rates for clones, a 2005 scientific review found that success rates in cloning remain less than 5%.

6. FDA asserts that the offspring of clones - not clones themselves - will be used for food and that genetic defects in clones are “corrected” in the offspring. But - as the Center finds, the National Academy of Sciences has questioned the validity of this assumption. Even more troubling, FDA downplays or omits from their assessment studies finding that some genetic defects in clones have been reproduced in clones' offspring.

7. FDA has stated that it will not require labels on food from animal clones. But a 2004 National Academy of Sciences study noted that a national system to identify and track food from animal clones "must be implemented" before cloned foods are marketed.

View the Executive Summary (PDF): http://www.centerforfoodsafety.org/pubs/NotReadyForPrimeTime_ExecSummary.pdf

View the full report, Not Ready For Prime Time: FDA's Flawed Approach To Assessing The Safety Of Food From Animal Clones (PDF): http://www.centerforfoodsafety.org/pubs/NotReadyForPrimeTime_FinalReport.pdf

Cloned food

Why Cloned Food Should Be Inedible and Unacceptable

Family Farm Defenders

On Dec. 28th, 2006 the FDA determined that food from cloned animals was fine for humans to eat. Consumers have until April 2nd, 2007 to provide their feedback. Once again, the U.S. is trying to lead the world over another cliff...

The mission of the U.S. Food and Drug Administration (FDA) is to protect the public's health through assuring the safety of our nation's food supply. The FDA's purpose is NOT to facilitate the dumping of dubious food products onto people's dinner plates for the sake of corporate profit. That is why it is so disturbing to hear about the FDA's Dec. 28, 2006 determination that cloned livestock byproducts are indeed safe for human consumption, and to read a subsequent wave of editorials clamoring for fullblown commercialization of cloned milk and meat.

Many people first learned about animal cloning back in 1997 when a sheep named Dolly was splashed across paper headlines and television screens. This sheep was created using a technique known as somatic cell nuclear transfer (SCNT), involving the transfer of genetic material from one animal into the egg of another and the subsequent implantation into the womb of a host. Biotech companies and venture capitalists were quick to tout the potential benefits of livestock cloning for producing pharmaceuticals, human organ transplants, as well as milk and meat. Left unsaid was that the average Dolly never sees the light of day, since 90% of cloned fetuses die before birth along with up to 25% of the surrogate mothers. In order to keep these hosts alive, cloning also requires much higher than usual animal treatment with hormones and antibiotics.

There are many valid reasons to be opposed to the sale of such milk and meat that go beyond the ethical debate about cloning itself. First of all, the FDA's decision relies upon the discredited pseudo-science of substantial equivalence. Dairy farmers and milk drinkers may recall that the FDA first unveiled this shoddy notion back in 1993 when it railroaded through approval of recombinant Bovine Growth Hormone (rBGH). Of course, now we know from a real scientific study (May 2006 Journal of Reproductive Health) that milk induced through genetic engineering is NOT the same as natural milk. But, because of the FDA's irresponsible rubberstamping, U.S. consumers are now suffering reproductive problems from having ingested rBGH dairy products for years with elevated levels of Insulin Like Growth Factor - 1 (IGF-1).

Statements by government officials and biotech apologists that cloned animals are simply genetic twins are also patently misleading. There have been numerous studies showing that once born cloned animals still suffer higher than normal morbidity and deformity rates. According to a leading cloning researcher, MIT Prof. Rudolph Jaensich, "You can not make normal clones. The ones that survive will just be less abnormal than the ones that die early." Basic science - let alone common sense - would suggest that this is symptomatic of other physiological problems and might not make a very healthy meal. Ian Wilmut, one of the scientists who created Dolly has publicly warned that even a slight imbalance in a cloned animal's hormone, protein, or fat levels could pose a danger to any would-be consumer. Nonetheless, one of the leading cloning outfits, ViaGen, has already entered into negotiations with Smithfield to put cloned pork into their products.

Worse yet, cloned animals are proposed for the production of industrial enzymes, pharmaceuticals, and other genetically engineered (GE) substances - aka biopharming. Longterm scientific studies have not been done to disprove concerns that biopharming residues will find their way into cloned meat/milk and then into people's mouths. It is bad enough having to worry about Mad Cow being served up with a hamburger, let alone GE spider webs.

Another criticism with the FDA's decision is that it undermines one of the fundamental principles of economic efficiency and marketplace competition, by failing to require labeling. Consumers can not make rational informed choices when they are denied the right to know about their food. By frustrating consumer sovereignty for the sake of corporate secrecy, the FDA is failing to serve the public interest. Given the sordid history behind rBGH, one would suspect that FDA approval of cloned food will give the green light to powerful corporations and their proxies to sue and/or fine smaller producers for daring to use the First Amendment and label their products as "clone-free." So much for the free market idea.

Once again , it seems the FDA is over eager to become an accomplice in the corporate forcefeeding of questionable byproducts to an unwitting populace. Whether it is genetic engineering, biopharming, nanotechnology, irradiation, or cloning, it is hard to escape the thought that U.S farmers and consumers are now guinea pigs caught up in some massive frankenfood experiment that the rest of the world is wise enough to watch from a safe distance.

Contact the FDA to Stop the Sale of Cloned Milk and Meat!

There is now a 90 day public comment period on the FDA's recent decision that cloned milk and meat are "substantially equivalent" to conventional livestock products and hence fit for human consumption. The deadline for public feedback is April 2nd, 2007. Please refer to Docket 2006P-0145 in any comments to the FDA.

By internet:
http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm?AGENCY=FDA

By mail:

FDA Div. Dockets Mgmt. (HFA-305) 5630 Fishers Lane, Rm. 1061 Rockville, MD 20857 By phone:

Toll free 1-888-463-6332

You can also contact your elected officials to demand mandatory consumer labeling and comprehensive safety testing of ALL food that is cloned or genetically engineered.

Congressional Switchboard: 1-202-224-3121

For more information:

Family Farm Defenders, 1019 Williamson St. #B, Madison, WI 53703 #608-260-0900 www.familyfarmdefenders.org Center for Food Safety, 600 Pennsylvania Ave #302 , Washington DC, 20003 # 202-547-9359 www.centerforfoodsafety.org Food and Water Watch, 1400 16th Street NW #225, Washington, DC 20036 # 202-797-6550 www.foodandwaterwatch.org

Cloned BSE-Free Cows, Not Safe Nor Proper Science

Dr. Mae-Wan Ho and Prof. Joe Cummins go behind the smokescreen to expose the project which would perpetuate the intensive animal husbandry that created mad cow disease in the first place and is far from safe or ethical in terms of animal welfare.

EXCERPT:

Large questions remain over the propriety, safety, ethics of creating cloned prionless cows

James Robl, chief scientific officer of Hematch of Connecticut, told the New Scientist in 2004 that the US company had only created the cell lines lacking the prion gene, and denied that cloned cows would be produced for food [15]. He said that the aim of the work was to use BSE-free cows to produce pharmaceutical products such as human antibodies, but that these cows were unlikely to end up on the dinner plate. That turned out to be a smokescreen, as we point out, there is no guarantee that hazardous experimental cloned transgenic cows will not enter the human food chain if transgenic and cloned animals are approved for human consumption [3, 4].

The project raises the question of whether it is proper science to devote such Herculean efforts to creating prionless cows, as it would merely perpetuate an intensive, industrial animal husbandry regime that created BSE in the first place. According to the UK Soil Association, which certifies organic agricultural produce [16], “there has never been a recorded case of BSE in an animal that was born in an organic herd where full organic management was in place throughout the animal's life.” This claim could not be refuted by subsequent investigations carried out as part of the UK government's BSE enquiry.

Prionless cows are both transgenic and cloned, and hence subject to the potential hazards and also the questionable ethics of both the transgenic and the cloning processes, regardless of whether they are intended for our dinner plate or for producing pharmaceuticals. Cloning creates massive deaths and suffering for failed foetuses and calves and also for the numerous surrogate dams required, and transgenesis in combination with cloning increases the number of cloning steps, and hence multiplies deaths and suffering.

It is not clear whether the calves still carry antibiotic resistance markers with loxP sites, the enhanced promoter from the SV40 virus, the Cre recombinase, or indeed, the diphtheria toxin A gene integrated at non-target sites in the genome. All of these dangerous genes could be subject to horizontal gene transfer and recombination, and in the process, trigger cancer (if transferred to human cells in the case of the strong viral promoter), and create and recreate viruses and bacteria that cause disease epidemics [4]. Cre-recombinase is known to scramble genomes (see Box 1).

In conclusion cloned transgenic animals should not be approved for commercial use, nor should public research funding go to support such projects. Cloned transgenic animals are far from safe on existing evidence, and certainly not ethical in terms of animal welfare.

Attack of the clones

Is FDA Promoting or Regulating Cloned Meat and Milk?

Dr. Mae-Wan Ho and Prof. Joe Cummins find cloned meat and milk unethical and unsafe.

(This article has been submitted to the FDA. Please circulate widely to your elected representatives)

US Food and Drug Administration (FDA) is about to approve cloned meat and milk for the market. But a large coalition of civil society organizations is opposing the decision on both safety and ethical grounds [1]. The coalition is led by the Center for Food Safety based in Washington DC, and includes the Humane Society with nearly 10 million members, and the Consumer Federation of America with membership of more than 50 million.

A recent poll commissioned by the International Food Information Council (a non-profit organization supported by the food, beverage and agricultural industries) found nearly 60 percent of respondents would not touch products from cloned animals with only 9 percent “very likely” to buy them. This compares with 40 percent who would not buy genetically modified animal products.

Misleading ‘risk assessment' by FDA and cloning companies

In preparation for FDA's approval of cloned animal products, the agency published a ‘commentary' in the January 2007 issue of Nature biotechnology [3] supported by a ‘perspective' piece on risk assessment, co-authored by scientists from at least two cloning companies [4]. Both papers put the same misleading positive gloss on cloned animals. The FDA paper explains why cloned meat and milk are as safe as the conventional products, because “there are no unique risks associated with animal cloning,” while the risk assessment commentary cites the FDA paper in agreement. Neither paper considers ethics or animal welfare.

Both papers present somatic cell nuclear transfer cloning (SCNT) reassuringly as the latest development in a “continuum” of artificial insemination, multiple ovulation/embryo transfer, in vitro fertilization, embryo cryopreservation, cloning by embryo splitting, and since the 1980s, by embryonic cell nuclear transfer (ECNT).

First of all, it is highly misleading to pretend that clones obtained by nuclear transfer are the same as clones obtained by embryo splitting. The latter is typically done at the 2-4 cell stage, and is not so different from the twins or multiplets that happen naturally from time to time.

Nuclear transfer cloning involves introducing the nuclei of embryonic cells (in ECNT) or adult somatic cells (in SCNT) into unfertilised eggs that has had the egg nucleus removed. The reconstituted eggs are then activated to develop, and the resultant embryos are implanted into surrogate mothers hormonally synchronized to receive them. Nuclear transfer cloning, especially SCNT results in extremely high failure rates from deaths and gross abnormalities, so much so that scientists speak of a “cloning syndrome” that arises from errors in epigenetic programming of the cell nucleus [5, 6]. The individual symptom may not be unique, but the combination and the high incidences of the symptoms certainly constitute a unique syndrome. It inflicts massive deaths, suffering and distress, not only to the cloned foetuses and the calves throughout gestation, at and after birth, but also to the surrogate mothers [7]. Surrogate mothers frequently die from difficult delivery unless medical intervention is given, and their health is seriously compromised by gross malformations of the foetuses.

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Admittedly, many deaths and gross abnormalities occur in animal cloning, but the companies claim that those clones born alive and survive the perinatal period are healthy [4]. To support their case, they tabulate nine studies, eight published elsewhere and one described in their paper, showing that the milk and meat products from clones are indistinguishable from controls, according to compositional studies on proteins, fats, somatic cell count, amino acid composition, vitamins, minerals etc, as recommended by the FDA [3].

Had the FDA recommended more discerning tests similar to those now routinely used in the laboratory for DNA, RNA, protein and metabolic profiling, large numbers of differences would have been detected, as SCNT clones are notorious for epigenetic errors that result in major changes in DNA markings, RNA and proteins expressed (see below), and it would be surprising if these did not result in metabolic differences.

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By any standards, these data are grossly inadequate to establish the safety of cloned meat and milk or any other cloned animal products. They are also fundamentally flawed, as single parameters are compared, rather than an entire pattern, so when differences did occur between the cloned and non-cloned siblings, they were dismissed by the comment that the values were within the normal range typical of the breed or species.

Clone Burgers- Minneapolis Star Tribune article

Editorial: Why 'cloneburgers' are a bad way to go
The danger isn't about food safety; it's about food security.

Published: January 16, 2007

If beef is what's for dinner at your house, you undoubtedly know the U.S. Food and Drug Administration is preparing to approve the sale of cloned meat and milk to U.S. consumers.

But a related and potentially more significant announcement probably escaped your notice: Researchers for a United Nations agency reported last month that livestock breeds around the world are disappearing at alarming rates, with as many as one-fifth of cattle, hog, goat, horse and poultry varieties facing extinction. Some 190 breeds have vanished in the last 15 years, and perhaps another 1,500 are already thought to be at risk.

These extinctions are driven by agricultural practices that perpetuate the most profitable breeds and neglect the rest. The results are a shrinking gene pool and, potentially, threats to global food security. The connection to cloning is that this high-tech practice is likely to make matters worse, not better.

Those issues don't really concern the FDA, whose OK for cloned animal products will be based on their safety for human health, a conclusion based in turn on tests showing that meat and milk from clones are identical to those from animals born naturally. But they ought to concern Congress -- and they ought to prompt consumers to think more broadly about how their food is produced.

For American consumers, at least, the advancing globalization and industrialization of agriculture have made many foods plentiful, cheap and available in every season. But there have been tradeoffs, too, perhaps the most noticeable being the increasing flavorlessness of mass-produced chicken, beef, pork and salmon.

Among some shoppers there is growing awareness that factory-like livestock operations produce animals in conditions ranging from misery to torture, while promoting the extinction of small-scale farming and farm-dependent rural communities. But most find it easy to look the other way.

When biotech food issues occasionally make the headlines, it is nearly always for a wrong reason. The big risk posed by genetically engineered crops isn't that they'll poison people, it's that they may transfer their new traits to other plants, with catastrophic consequences. The problem with irradiation isn't that consumers will get radiation poisoning, it's that signs of declining freshness are masked.

And the big problem with the coming use of cloned livestock on production scales is not that "cloneburgers" will be dangerous to human health, nor even the uncomfortable reality that animals produced this way are much likelier to be defective at birth.

It's that this way of engineering foods, like so many previous production-oriented manipulations, will continue to narrow the diversity of food sources and thereby enlarge their vulnerability to disease, pests or other causes of collapse. Such is the unavoidable high price of cheap food.

Editorial sobre clonación

Food from cloned animals
These products should remain in the lab

By David Schubert
January 3, 2007

It is curious that the U.S. population seems willing to act as guinea pigs solely for the financial benefit of a few companies. This is most recently exemplified by the lack of outcry over the U.S. Food and Drug Administration's move toward allowing the sale of milk and meat from cloned animals without any required labeling. The FDA decision is another example of the continuing sway that the U.S. agricultural biotechnology and chemical companies have over federal agencies.

The conclusion that cloned animal products are safe to eat is based almost completely on data and arguments provided by the companies that will profit from their sale. Similar scenarios allowed the introduction of genetically modified, or GM, foods 10 years ago, and the massive and largely unregulated introduction of pesticides after World War II.

The development of an agricultural system based on chemical pesticides, fertilizers and herbicides led to an increase in farm productivity and cheaper food. But it also blanketed our planet with chemicals now known to cause cancer, birth defects and huge environmental problems as well as bringing about economic disparities between populations who do and do not have the technology. More important, however, is the realization that had we given a little more thought and study to agricultural methods at the time, we would have come up with the more sustainable farming methods that are now being widely adapted.

Innovation and technological advancement are major driving forces for modern society, but they must be done in the context of both need and potential risk. Many European countries have outlawed toxic agricultural chemicals that are still widely used in the United States, and require much more stringent testing for adverse health and environmental effects before the introduction of new ones.

As with cloned farm animals, the introduction of GM food crops into our food supply was allowed by the FDA with essentially no regulatory oversight because it was claimed they were just like normal plants. GM crops were promoted as a way make food cheaper, reduce the need for agrochemicals and eliminate world hunger. Ten years after their introduction, there is no reduction in food cost, the worldwide use of chemicals on the farm has increased greatly, and world hunger is worse than ever. In addition, farmers have lost millions of dollars due to GM crop failures and closed export markets resulting from GM contamination because many countries do not allow GM foods.

The only benefactors of the GM technology have been the small group of companies that control over half of the world's seed supply and make 90 percent of the chemicals used in agriculture. Monsanto is the biggest player, controlling 41 percent of the global seed market for corn and 25 percent for soybeans. Its dominance was achieved through huge contributions to politicians, the intimidation of farmers, bribery and the perpetual harassment of individuals who oppose their views. If absolute control of our food supply is the goal, then the next step for agricultural biotechnology is to dominate the milk and meat markets through animal cloning.

As with the introduction of chemical agriculture and GM plants, animal cloning is a new and untested technology. Its famous first was Dolly the sheep. Cloning involves removing the genetic material from an egg, replacing it with that of the animal to be cloned, and then implanting the egg in the surrogate mother to which the clone is born. The advantage of animal cloning over breeding is that it eliminates the innate randomness of normal breeding and therefore is thought to assure that the desired characteristics are present in each clone. The trade-off, as with GM crops and pesticides, it that the health hazards to the consumer could be significant.

For example, to trick the surrogate mother into thinking that she is pregnant, she must be treated with high levels of hormones that will certainly enter our food supply along with her body parts. In addition, many clones are born with severely compromised immune systems. A good example is Dolly, which led a short, albeit glamorous, life due to multiple medical problems. It will therefore be necessary to treat cloned animals with antibiotics, which will further drive the selection for antibiotic resistant pathogens, already a major medical problem. Indeed, the National Academy of Sciences warned that cloned farm animals would likely increase the incidence of food-borne infections.

A logical extension of cloning is to make transgenic animals that contain genes from plants or other animals. This has in fact been done to solve a problem presented by the use of synthetic growth hormone to force cows to produce more milk. Since the super milk producer gets infections of her udder, the high-tech solution was to make a transgenic cow that produces its own antibiotics. Next up, cattle that make their own barbecue sauce.

Why is there such a drive to produce the type of laboratory-derived food represented by GM crops and cloned animals? Since the major, if not the only, benefactors of GM crop and animal cloning technologies are the companies that own them, it is clear the drive for their introduction is corporate profit. It is always assumed that the market drives the technology, but in the case of agricultural technology, supported by an enormous amount of money and political capital and the fact that the consumers do not seem to care, the reverse is clearly true.

And why are these products readily accepted in a country that has an overabundance of cheap food, while most of the world rejects this approach? The reason the U.S. population does not spend much time thinking about the origin of its food is because it believes the FDA is doing the necessary safety testing. In fact, there is no required safety testing for GM crops; there will be none for cloned animals.

The Europeans do not harbor this assumption because they have experienced dramatic failures of their regulatory agencies in the form of mad cow disease and HIV-infected blood supplies. An additional problem is that in the laboratory we only use guinea pigs in experiments where we can detect the outcome, while any adverse effects of biotech food on human health will be undetectable against the background of current medical problems. Therefore the claim that these foods are safe because there is no evidence of harm is invalid. It would seem to me that the toxic consequences of chemical farming and the failure of GM crop technology to produce any human benefit should force us to question the blind acceptance of yet another untested and unregulated agricultural practice.

Schubert is a professor at the Salk Institute for Biological Studies.

http://www.signonsandiego.com/uniontrib/20070103/news_lz1e3schubert.html

from Pete Shanks

from Pete Shanks, author of Human Genetic Engineering: A Guide for Activists, Skeptics, and the Very Perplexed

Hi there

The Center for Genetics and Society (CGS) now has a blog, at http://www.biopoliticaltimes.org/, where various members of the CGS staff post and so occasionally do guests such as myself. The central topic is human biotech, but broader connections are often drawn. The intro is at http://www.biopoliticaltimes.org/2006/10/welcome.html.

I recently put up an item about the connections between the Food and Drug Administration (FDA) livestock-cloning report and the cloning companies and in turn their founders, who have human GE interests.

It's at http://www.biopoliticaltimes.org/2007/01/cloned-meat-hidden-
agendas-behind.html and also copied below, but without the links and formatting. [We've added some of the links below - ed]

It's public comment time at the FDA...

best
pete
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Cloned Meat: the hidden agendas (behind the other hidden agendas)

posted by Pete Shanks

http://www.biopoliticaltimes.org/2007/01/cloned-meat-hidden-
agendas-behind.html

Who is pushing to legalize cloned meat? Follow the money -- and there are strong connections to human genetic engineering.

The Food and Drug Administration (FDA)'s draft risk assessment leans heavily on the work of animal-cloning companies Cyagra and ViaGen. Over a quarter of the 700-page draft is a data dump from those two -- a fact that the New York Times failed to mention, even when quoting the president of ViaGen saying "I think that this draft is going to provide the industry the comfort it needs."
http://www.fda.gov/cvm/CloneRiskAssessment.htm
http://www.nytimes.com/2006/12/28/business/28cnd-clone.html

ViaGen is part of the Exeter Life Science Group, owned by billionaire John Sperling, who also financed the notorious Genetic Savings and Clone (GSC). Viagen's chief scientist, Irina Polejaeva, was once GSC's, and when GSC closed ViaGen took over their gene banking operation. The cloned pets were rightly described by Wired as "a footnote to John Sperling's grand plan" -- and so are the cows and pigs. The plan is people -- living forever.
http://www.genetics-and-society.org/resources/items/20020429_
fortune_warner.html
http://www.wired.com/wired/archive/12.02/immortal.html

Cyagra was a subsidiary of Advanced Cell Technology (ACT), of press-release infamy. ACT sold Cyagra in one of its desperate grabs for cash, but chief scientist Robert Lanza and his former colleague Jose Cibelli (a co-author of Hwang Woo-suk's and a former consultant to the California stem cell institute -- it's a small universe) are cited throughout the FDA report.

The surface agenda the FDA addresses is public safety (though Stuart Newman [professor at New York Medical College] says "it's potentially a health hazard"); the agenda hidden in plain sight is that of commercial interests; and behind that lies the specter of human genetic engineering. It's a mutually reinforcing spiral: The animal cloners have been relying on human medical research (and of course feeding the starving) to make their work seem less unacceptable -- and the human cloners rely on the animal work to make theirs seem more reasonable.
http://www.thejournalnews.com/apps/pbcs.dll/article?AID=/
20070101/NEWS02/701010332/1018

The public does not want cloned meat and certainly wants it to be labeled, which the FDA says it cannot require. All the more reason to object now. The Center for Food Safety has been opposing animal cloning for years. So has the Organic Consumers Association, which has set up a handy site for responding to the FDA's call for public comment.
http://www.organicconsumers.org/rd/clones.htm

CFS on animal cloning

Despite Lack of Science and Strong Public Concern, FDA Expected to OK Food From Cloned Animals

Center for Food Safety

FOR IMMEDIATE RELEASE:
DECEMBER 26, 2006

Contact:

Joseph Mendelson, CFS,
(202) 547-9359, (703) 244-1724 (cell);

Andrew Kimbrell, CFS,
(202) 547-9359, (703) 927-2826 (cell)

WASHINGTON - The U.S. Food and Drug Administration (FDA) is expected later this week to release a preliminary safety assessment that clears the way for marketing of meat and dairy products from cloned animals for human consumption. The assessment and the agency's expected endorsement of cloned food comes despite widespread concern among scientists and food safety advocates over the safety of such products. The move to market cloned milk and meat also flies in the face of dairy and food industry concern and recent consumer opinion polls showing that most Americans do not want these experimental foods.

"Instead of doing its job, the Bush FDA has ignored the science and fast-tracked this decision for the benefit of a few cloning companies,"said Joseph Mendelson, Legal Director for the Center for Food Safety (CFS). "This is a lose-lose situation for consumers and the dairy industry."

The FDA action follows the recent news that the agency has refused to investigate health problems in animal clones on a U.S. dairy farm. Greg Wiles, whose Williamsport Maryland "Futuraland 2020"dairy was the first farm in the nation to have cloned cows, told FDA that one of his two cow clones was suffering from unexplained health problems. Wiles told Food Chemical News that the clone "just stopped growing...she just looks terrible," but says that when he reported the problems to FDA and other federal officials, he was "paddled around like a tennis ball from agency to agency."CFS has asked the Agriculture Department to intervene in the case to stop any sale and prohibit the slaughter of clones and their progeny for food.

In October, CFS, joined by a coalition of consumer, environmental and animal welfare organizations, filed a legal petition with the FDA seeking a moratorium on foods produced from cloned animals and establishment of mandatory rules for pre-market food safety and environmental review of cloned foods (see the petition HERE). The petition also requested that the Department of Health and Human Services establish a federal review committee to advise FDA on the ethical issues raised by animal cloning.

Recent opinion polls also show that Americans are overwhelmingly concerned about animal cloning for food production. A November 2006 food industry poll conducted by the International Food Information Council showed that 58% of Americans surveyed would be unlikely to buy meat or milk from animal clones even if FDA found such products to be safe. In the same poll, only 16% of Americans had a favorable opinion of animal cloning. A December 2006 poll by the Pew Initiative found that 64% of those polled were uncomfortable with animal cloning, with 43% saying that cloned food is unsafe, while another 36% felt unsure about cloned food safety.

The FDA's action also follows growing opposition to the use of clones and their progeny for food products on Capitol Hill. In November, Senator Barbara Mikulski sent a letter to the FDA requesting a complete overview of how the agency came to its decision of using clones in food. In early December, a bi-partisan group of seven senators led by Senator Patrick Leahy asked FDA to reconsider its assessment of cloned animals. The International Dairy Foods Association, representing major dairies and food makers including Kraft, Nestle and others, also has opposed allowing products from cloned animals into the food supply at this time.

Cloning scientists have acknowledged that genetic abnormalities are common in clones, yet FDA failed to address how food safety and animal welfare concerns could be managed if cloning is widely adopted by the livestock industry. Some of the health and safety problems in animal cloning include:

* Surrogate mothers are treated with high doses of hormones; clones are often born with severely compromised immune systems and frequently receive massive doses of antibiotics. This opens an avenue for large amounts of veterinary pharmaceuticals to enter the human food supply;
* Imbalances in clones' hormone, protein, and/or fat levels could compromise the quality and safety of meat and milk;
* The National Academy of Sciences warned that commercialization of cloned livestock for food production could increase the incidence of food-borne illnesses, such as E. coli infections;
* Cloning commonly results in high failure rates and defects such as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems.

"There is widespread concern among Americans, and scientific concern that cloned food may not be safe and that cloning will increase animal cruelty,"said Mendelson. "We intend to pursue our legal action to compel FDA to address the many unanswered questions around cloned food."

Notes:
Center for Food Safety's Legal Petition and background documents are available HERE

Letter from Senator Patrick Leahy, et al to Dept of Health and Human Services at
http://leahy.senate.gov/press/200612/Leahy%20Letter%20to%...

The International Food Information Council poll report and results are at http://ific.org/research/upload/2006%20Biotech%20Consumer...

The Pew Initiative on Food and Biotechnology poll and results are at http://pewagbiotech.org/research/2006update/

Animales clonados

FDA set to OK food from cloned animals TODAY (28/12/2006)

GM WATCH COMMENT: According to this Associated Press piece, the US government is expected to declare today that cloned animals are safe to go into the human food supply.

There has, of course, been no public debate about whether US citizens, let alone the recipients of US exports, wish to consume milk and meat from cloned animals.

And this isn't just an issue of democratic deficit.

A spokesman for the Biotechnology Industry Organization is quoted in the article as saying, "We clone an animal because we want a genetic twin of that animal. It's not a genetically engineered animal; no genes have been changed or moved or deleted."

But we know clones are very far indeed from perfect copies and that all clones are, in one way or another, defective with multiple flaws embedded in their genomes. Rudolf Jaenisch, a geneticist at the Massachusetts Institute of Technology, estimates that something like 4-5% of the genes in a cloned animal's genome are expressed incorrectly.

And these genetic defects can have tangible results - some subtle and hard to reckon but others all too clear. Some clones have been born with incomplete body walls or with abnormalities in their hearts, kidneys or brain function, or have suffered problems like "adult clone sudden death syndrome" and premature ageing.

Quite apart from the uncertainties, and any health concerns, the defects of clones may pose for consumers, people might well wish to avoid the products of a process that is so disastrous for animal welfare. But, as with GM, they won't be given the choice - food from clones will not be labelled.

From rogue GMOs in your rice to pharmaceuticals in your corn flakes, to cloned beef in your burger, America's food chain is shaping up as the world's most exotic.

EXTRACT: "Consumers are going to be having a product that has potential safety issues and has a whole load of ethical issues tied to it, without any labeling," said Joseph Mendelson, legal director of the Center for Food Safety.

Carol Tucker Foreman, director of food policy at the Consumer Federation of America, said the FDA is ignoring research that shows cloning results in more deaths and deformed animals than other reproductive technologies.

The consumer federation will ask food companies and supermarkets to refuse to sell food from clones, she said.

"Meat and milk from cloned animals have no benefit for consumers, and consumers don't want them in their foods," Foreman said.
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Announcement on cloned animals expected today
FDA set to OK food from cloned animals
By Libby Quaid
THE ASSOCIATED PRESS, December 28, 2006

Cloned animals

GROUPS TELL FDA, KEEP FOOD FROM CLONED ANIMALS OFF OUR DINNER PLATES

Legal Petition to FDA Highlights Unresolved Food Safety, Animal Welfare and Ethical Issues and Calls for a Federal Moratorium on Cloned Food

FOR IMMEDIATE RELEASE
October 12, 2006

CONTACT: Center for Food Safety, Joseph Mendelson or Jaydee Hanson, (202) 547-9359; Will Rostov, 415-826-2770

Washington, DC – The Center for Food Safety, along with reproductive rights, animal welfare, and consumer protection organizations, today filed a legal petition with the Food and Drug Administration (FDA) calling for a moratorium on the introduction of food products from cloned animals. While the biotechnology industry is rushing to commercialize cloned food, there is serious scientific concern about the food safety of products from clones. Moreover, many are concerned that the cloning process results in deformities and other animal health problems that bring new animal cruelty issues to agriculture. The petition also asserts that Americans do not want to eat cloned food and many have strong religious and ethical objections to animal cloning which should be addressed in the regulatory process.

“Cloning is completely unnecessary and will increase animal cruelty in food production, yet the industry wants to test their cloned foods on the American public,” said Joseph Mendelson III, Legal Director for the Center for Food Safety (CFS). “We believe that all Americans want to protect our children from these potentially unsafe foods and would reject cloned foods that jeopardize animal welfare protections.”

The petition calls on FDA to enact a moratorium on foods produced from cloned animals and establish mandatory rules for pre-market food safety and environmental review of cloned foods. The petition also calls for the Department of Health and Human Services to establish a federal review committee to advise FDA on the troubling ethical issues raised by animal cloning.

Recent polls show that Americans would refuse to buy food from cloned animals, and that Americans have serious concerns about the ethics of animal cloning. An independent poll last year found that 2/3 of Americans are uncomfortable or strongly uncomfortable with animal cloning, and 77% were unsure about the safety of cloned food, including 43% who stated that cloned food would be unsafe. A food industry-sponsored poll last year similarly found that 63% of Americans would not buy cloned food, even if FDA deemed the products safe.

The safety of food from clones is far from assured. The legal petition filed today notes that there is scant data on the safety of food from clones, and that cloned animals are often unhealthy and can have hidden health defects that may lead to food safety risks. A 2004 New England Journal of Medicine report stated that “[G]iven the available evidence, it may be exceedingly difficult, if not impossible, to generate healthy cloned animals….” In 2003, FDA’s draft assessment on cloned food safety relied on just a single study on cloned milk, and no studies on meat from cloned animals. A 2004 National Academy of Sciences report said that the safety of cloned food could not be asserted because “the paucity of evidence in the literature on this topic makes it impossible to provide scientific evidence to support this position.”

Despite the lack of safety data, the biotechnology industry is rushing to market food from cloned animals. FDA has no regulations prohibiting the sale of food from cloned animals; in 2003, the agency asked cloned animals to keep their food products off the market voluntarily. But last year, the Associated Press reported that one cloning company had cloned pigs and beef cattle ready for commercialization. Cloned dairy cows have been producing milk on farms in the U.S. for at least five years, and some in the cloning industry have suggested that they may disregard FDA’s request.

Animal welfare organizations also strongly oppose cloning, as recent cloning research has resulted in high failure rates, premature deaths, and such abnormalities as intestinal blockages; diabetes; shortened tendons; deformed feet; weakened immune systems; dysfunctional hearts, brains, livers, and kidneys; respiratory distress; and circulatory problems. "The Humane Society of the United States is committed to scientific advancement, but only that which has a legitimate social value and improves--not decreases--animal welfare, two critical components lacking in the case of developing commercial cloning of farm animals," said Wayne Pacelle, President and CEO of HSUS, a co-petitioner on today’s legal filing. "As recently as June 2005, an FDA representative stated that cloned animals were more likely to suffer birth defects and health problems when very young, demonstrating these problems have not been resolved."

Religious and reproductive rights groups also oppose cloning for food production. "Supporters of reproductive choice know that this technology has nothing to do with women’s health,” said Reverend Carlton W. Veazey, President and CEO of the Religious Coalition for Reproductive Choice. “Animal cloning companies are not interested in promoting healthy options for women; they are seeking quick profits from food experiments that raise troubling ethical concerns.” In 2001, more than 100 reproductive rights and women's health organizations called on Congress to ban human reproductive cloning.

Previously, many religious organizations have raised ethical objections to new genetic technologies. In 1995, more than 200 U.S. religious leaders, including those from the Protestant, Catholic, Jewish, Muslim, Hindu and Buddhist faiths, announced a joint opposition to the patenting of animal genes, tissue, organs, and organisms. The groups cited their belief that genetic manipulation and life patenting shifted “authorship” of life from ‘God’ to scientists and lab-technicians. The petition today asserts that these widespread and strongly held beliefs, along with animal cruelty and other concerns calls for broad public participation before animal cloning is used for greater industry profits.

The CFS petition asserts that, under the Federal Food and Drug Cosmetic Act (FFDCA), any animal clone intended for food should be regulated as a new animal drug. Under the FFDCA, the term “drug” means any “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Petitioners argue that cloning fits within this broad definition. FDA is already regulating genetically engineered animals as new animal drugs under this provision of the FFDCA, and the agency has told Congress that any human cloning research could not proceed without a similar investigational new drug review under FFDCA.

Also joining CFS in petitioning FDA today are the Consumer Federation of America, Food and Water Watch, Friends of the Earth, the American Anti-Vivisection Society, Humane Society of the United States, the Religious Coalition for Reproductive Choice and the Center for Environmental Health. The petition, along with an Executive Summary and other background information on the risks of animal cloning are online at www.centerforfoodsafety.org.

Joseph Mendelson III| joemend@icta.org
Legal Director

Center for Food Safety &
Int'l Center for Technology Assessment

660 Pennsylvania Ave., SE Suite 302
Washington, DC 20003
www.centerforfoodsafety.org