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RISK ASSESSMENT / FOOD: FDA 'cherry picked' evidence to pushcloned-animal foods



                                 PART I
------------------------------- GENET-news -------------------------------
TITLE:  FDA 'cherry picked' evidence to push cloned-animal foods
SOURCE: The New Standard, USA
AUTHOR: by Michelle Chen
URL:    http://newstandardnews.net/content/index.cfm/items/4543
DATE:   22.03.2007
--------------------------------------------------------------------------


FDA 'cherry picked' evidence to push cloned-animal foods

Mar. 22 - A watchdog group is challenging the US government's stance on
food from cloned animals, accusing regulators of downplaying evidence of
health risks in order to serve industry interests.

A report released yesterday by the Center for Food Safety, a research
and advocacy organization that supports a federal ban on cloning
livestock, says the US Food and Drug Administration (FDA) has
selectively applied the research tying cloning to genetic abnormalities.

With the biotech industry pushing to introduce clones to the country's
food supply, the FDA is finalizing a favorable "risk assessment" for
products derived from animal-cloning technology. While requesting that
agricultural producers refrain for now from selling food generated
through cloning, the agency declared in December that current research
"has not identified any food-consumption risks or subtle hazards in
healthy clones of cattle, swine or goats."

But the Center for Food Safety argues the FDA's official safety claims
are based on skewed interpretations of sparse or inconsistent scientific data.

For instance, the FDA's review of available research relied heavily on
studies that looked not at consumption of clone-derived food
specifically, but rather at the physiology of cloned animals. The
agency's methodology assumed a link between animals' health and the
safety of the food produced from them.

The Center for Food Safety also criticized the FDA's focus on data
provided by the biotech firms Viagen and Cyagra, which have a financial
stake in cloning for agriculture.

At the same time, the FDA noted several studies showing relatively high
rates of large-offspring syndrome in newborn cloned animals. The
syndrome, according to the agency, typically involves excess body
weight, "abnormalities of the lungs and other parts of the body, and...
cardiovascular and respiratory problems." But the agency stressed that
"clones that reach reproductive age appear to be normal... and appear to
give rise to healthy, apparently normal progeny." The agency also said
genetic "errors" related to the cloning process would not pass on to
subsequent generations developed through conventional breeding.

The Center for Food Safety, however, pointed to a 2003 study, not cited
in the FDA assessment, by researchers at the University of Sydney in
Australia, suggesting that cloned animals could in fact transfer such
traits to offspring.

Despite the FDA's uniformly optimistic conclusions, some of the studies
it cited displayed contrasting outcomes.

According to the FDA's survey of research on cloned cows since the
mid-1990s, survival rates past birth ranged from zero to 100 percent.
Research submitted to the FDA by Cyagra showed that of 134 cloned
animals in its study, at the time the data was collected in 2003, only
half were still alive. Causes of death among the clones included
developmental defects, circulatory problems, and euthanasia due to
"failure to thrive."

Similarly, in examining the nutritional composition of clone-derived
meat and milk - based on Viagen and Cyagra's own datasets alongside
other published and unpublished research - the FDA discerned no
"significant differences" between cloned and non-cloned animal products.

But the Center for Food Safety's analysis of the studies found that the
studies did cite various discrepancies between the cloned and non-cloned
animals in fat and protein composition.

"From the very start, the FDA narrowed the terms of their risk
assessment," Charles Margulis, author of the Center's report, told The
NewStandard. The Center blasted the risk assessment for not even
broaching some of the deeper issues surrounding cloning: animal welfare
and ethics, for example, or how overall biodiversity and the environment
could be impacted by large-scale genetic manipulation of animal populations.

The agency's "cherry picking of the data," Margulis argued, is framed
around conclusions that support the interest of biotechnology firms,
which stand to gain from the commercialization of cloned and genetically
altered livestock, bred to produce food with more profitable qualities.

The FDA, which refused to comment on the Center's report, will close the
public-comment period for its risk assessment on April 2.


-------------------- archived at  http://www.gene.ch/ --------------------


                                  PART II
------------------------------- GENET-news -------------------------------
TITLE:  New CFS report says FDA plan to approve sale of food from animal
        clones is based on wishful thinking, not science
SOURCE: The Center for Food Safety, USA
AUTHOR: Press Release
URL:    http://www.centerforfoodsafety.org/AnimalCloning_PR3_21_07.cfm
DATE:   21.03.2007
--------------------------------------------------------------------------


New CFS 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:

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


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART III
------------------------------- GENET-news -------------------------------
TITLE:  Milk from cloned cows may soon appear in a dairy case near you
SOURCE: Chicago Defender, USA
AUTHOR: Medill News Service, by Celeste Kennel-Shank & Zena McFadden

URL:    http://www.chicagodefender.com/page/national.cfm?ArticleID=8743
DATE:   12.03.2007
--------------------------------------------------------------------------


Milk from cloned cows may soon appear in a dairy case near you

Are you ready to drink milk from a cloned cow?

The Food and Drug Administration is accepting responses from the public
until April 2 about animal cloning and whether it should give final
approval to allow milk and meat from cloned animals or their offspring
to enter the food supply.

Consumers already have choices to buy milk free of antibiotics and
hormones or milk from cows raised using certified organic feeds.

But consumers buying milk produced by cloned cows or their offspring
won't know it because, on Dec. 28, the FDA announced that products from
cloned animals are safe to eat.

Products from cloned animals would not be specially labeled because the
FDA does not view them as different products, the agency states on its
Web site. "There is no science-based reason to use labels to distinguish
between milk derived from clones and that from conventional animals."

Illinois researchers, consumers and farmers disagree on whether it's
safe to drink milk produced from cloned cows, however.

"Cloning is another way to advance the technology of breeding" to get
more milk and be more efficient, dairy farmer Steve Heinsohn of Kirkland
said. "It is just a new technology."

But grocery store clerk Devyn Slemp of Sycamore said she wouldn't buy
milk from cloned animals. "I would be kind of afraid to drink it."

Thinking most consumers agree with Slemp, several dairy processing
companies have said they will not buy milk from cloned cows even if the
FDA approves its sale. The largest U.S. milk processor and distributor,
Dean Foods Co. of Dallas, announced Feb. 23 that it won't buy milk that
has come from cloned cows. Dean also owns Land O'Lakes and Horizon Organic.

The makers of Ben and Jerry's ice cream, based in Vermont, oppose using
milk from cloned animals, and are advocating against it on the company
Web site.

Whether the cause for concern is real or due to fear has yet to be seen.
"We need to be careful about hysteria about the unknown," said Rex
Chisholm, director of the Center for Genetic Medicine at Northwestern
University. "A lot of times when we make genetic changes we get
unintended consequences," he said. "Our lives are full of unintended
consequences."

Studies of public opinion on animal cloning and the food supply
documented by the Food Policy Institute at Rutgers University suggests
that the word cloning conjures up negative ideas of science fiction.
Research indicates that most people know little about the science of cloning.

Chisholm thinks people should have more confidence in the process. If
you handed over a glass of milk and "told me this is milk from a cloned
cow, I wouldn't think twice about drinking it," he said.

Humans have been manipulating the genes in food for thousands of years,
Chisholm said. Long before people knew what genes were, they selectively
reproduced the plants and animals they preferred, altering their gene
pools, he said. Current breeding techniques to reproduce prized cattle
and bulls are not far from cloning, he added.

Although Chisholm supports use of the products, he is in favor of
labeling the food from cloned or genetically modified animals, unlike
the FDA. "When people use the products and find out they are no
different than anything else, this whole thing will go away," he said.

A study by the FDA's Center for Veterinary Medicine said there is
nothing to be afraid of when it comes to food from cloned animals.
Cloned animals had no distinct traits different from those seen in
animals born through artificial reproductive methods or traditional
animal mating, reported Larisa Rudenko and John Matheson of the center
in a study published in the Jan. 1 issue of the animal reproduction
journal "Theriogenology."

"The agency therefore concluded that food from cattle, swine and goat
clones was as safe to eat as food from animals of those species derived
by conventional means," said the study report.

Heinsohn agrees that there is no difference in milk from clones or their
offspring. "There is nothing physically wrong with the product that
comes out of them, because it is still [from] a cow," he said.

Reproductive cloning in animals involves taking the nucleus, where a
cell's genetic material is found, out of an egg cell and adding a
nucleus extracted from another cell of the animal. The new nucleus is
the equivalent of a fertilized egg and can then be implanted in the
animal who donated the cells or in a surrogate.

Cloned animals are not born looking exactly like their mothers, but
rather, more like an identical twin raised years later under different
environmental circumstances. Thus, a clone can be a genetic twin yet
have unique individual characteristics, since genes may be expressed
differently under different circumstances.

Those opposed to cloning suggest that animals who are cloned suffer from
more illnesses than those created naturally. Some research has shown
they live shorter lives.

Kenneth Cunniff, director of the International Institute for Animal Law
in Chicago, said he does not think cloning endangers the animals being
reproduced. "It wouldn't be any different than any in-vitro
fertilization in humans. I don't think there is any animal suffering
involved."

Some dairy farmers see cloning as a way for farmers to breed their best
milk producers, the FDA Web site suggests.

Heinsohn said other earlier reproductive technologies were viewed with
suspicion when first introduced as well. Artificial insemination, for
example, was initially considered "suspect" and today is now considered
acceptable technology for both livestock and humans. It depends on how
much of a "purist you are on being natural," he said.

To comment on the FDA decision, go to www.fda.gov and choose "animal
cloning" under hot topics. Summaries of the plans for risk assessment
and management are available, as well as instructions on submitting
comments online or in writing.


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART IV
------------------------------- GENET-news -------------------------------
TITLE:  EU considers allowing cloned meat, milk on market
SOURCE: Food Navigator, France
AUTHOR: Ahmed ElAmin
URL:    http://www.foodnavigator.com/news/ng.asp?n=74840-cloned-dolly-efsa
DATE:   09.03.2007
--------------------------------------------------------------------------


EU considers allowing cloned meat, milk on market

09/03/2007 - Meat and milk from cloned animals could soon become
available in the EU, depending on the outcome of a European Food Safety
Authority scientific review.

EFSA reported yesterday that the European Commission had asked it for
advice on the implications of animal cloning on food safety, animal
health and welfare and the environment.

Cloning could provide processors with a better quality of meat and other
products, such as dairy. Cloning offers the possibility of creating
strains of animals with increased disease resistance and other qualities.

However consumer resistance is bound to pose a problem, as happed in the
case of attempts to introduce genetically-modified foods in the bloc.

The Commission request asks for advice on food safety, animal health,
animal welfare and environment implication of "live cloned animals,
obtained through somatic cell nucleus transfer (SCNT) technique, their
offspring and of the products obtained from those animals."

EFSA is the scientific risk assessor for novel foods proposed for
introduction in the EU's food chain. The Commission made the request of
opinions both from EFSA and the European Group of Ethics.

Animal cloning issues cut across different EFSA scientific panels, the
agency said. 

At present in Europe cloning is not a commercial practice and there is
no specific regulation on the authorisation of food products from cloned
animals for human consumption in the EU.

EFSA's opinion will therefore help inform any future EU measures for
cloned animals and their products.

"EFSA has already begun considering how best to address this issue in
anticipation of the possibility of such a request, and will now discuss
with the Commission the request received," the agency stated. "A final
mandate will be agreed with the Commission, taking into account issues
such as the proposed timetable for working on such a complex opinion."

EFSA plans to produce a report within six months.

The issue reared its head in the EU earlier this year after the UK's
Food Standards Agency revealed in January that the calf of a cloned cow
was being raised on a UK farm.

After food safety officials from the 27 member states held urgent talks
on the matter, a decision was reached that milk and meat from cloned
animals and their offspring should be considered in the same way as any
other novel food, such as genetically-modified organisms (GMOs).

This decision put the ball in EFSA's court.

In the US, debate surrounding the issue gathered momentum in recent
months, after the US Food and Drug Administration (FDA) said it planned
to approve cloning for food production later this year.

The US regulator has issued a consultation proposing to allow the
product into the food chain without the need for labelling.

An independent study in the US indicates that 60 per cent of Americans
would not knowingly eat cloned meat. A 2002 EU survey found that
Europeans were generally against any new foods that had been produced
through new scientific advances - such as GMOs.

Cloning uses DNA technology to produce multiple, exact copies of a
single gene or other segment of DNA. It refers to the creation a new
mutlicellular organism, genetically identical to another.

Reproductive cloning is a technology used to generate an animal that has
the same nuclear DNA as another currently or previously existing animal,
according to Wikipedia.

Cloning came to the forefront in 1996 when Dolly, a ewe, became the
first mammal to have been successfully cloned from an adult cell.

She was cloned at the Roslin Institute in the UK and died after six years.


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART V
------------------------------- GENET-news -------------------------------
TITLE:  The beef with cloned meat
SOURCE: Scientific American, USA
AUTHOR: The Editors
URL:    http://www.sciam.com/article.cfm?chanID=sa006&articleID=C716B55E-
E7F2-99DF-3DE129EA7AA82596&colID=2
DATE:   19.02.2007
--------------------------------------------------------------------------


The beef with cloned meat

The waiter places a perfectly grilled, prime-grade beefsteak before you
and then reveals that it came from a cloned steer. Do you eat it? For
most Americans, the answer is no. A survey conducted by the Pew
Initiative on Food and Biotechnology found that the thought of dining on
meat from animals copied via manual transfer of cell nuclei just does
not sit well with six in 10 of us. Blame ethical or religious concerns
or mistrust of the meat industry, but the idea of cloned meat elicits
distaste even in many confirmed carnivores.

Is that gut reaction justified? From a food-safety standpoint, probably
not. In January, after reviewing available scientific reports about
animal cloning, the U.S. Food and Drug Administration released a risk
assessment asserting that food (including milk) from cloned cattle,
swine and goats is "likely to be as safe as" that from non-cloned animals.

The FDA's expected approval is unlikely to bring cloned meat products to
store shelves soon, because cloning is still difficult and, hence, too
expensive for routine food production. But ranchers and dairy producers
may be willing to pay more than $15,000 for a "rock star" breeding
animal with superior genetics. Proponents claim that cloning these
individuals will yield elite animals with desirable traits, such as
general good health, disease resistance, greater productivity or leaner,
tastier meat--without growth stimulants. The offspring of those clones
will probably be the first to arrive at the dinner table. The
distinction between this procedure and conventional animal husbandry
would be the use of a genetic copy as breeding stock.

Detractors claim that this rosy scenario overlooks unresolved issues.
Clone-based pregnancies, for example, result in more miscarriages,
deformities and premature deaths than other methods do, but the FDA
argues that these animal-welfare problems are not unique to cloning and
that none are linked to human health risks. Many critics also fear
overreliance on vulnerable monocultures of genetically identical animals
that could be wiped out by a single disease. Even some members of the
farm industry oppose animal cloning because cloned meat and dairy
products could be shunned overseas, where food from genetically modified
crops is often banned.

Perhaps the real issue here is one of full disclosure regarding our
foodstuffs. Many meat eaters may be surprised to learn that the cattle
industry has long employed a process called budding, in which
technicians manually separate the undifferentiated cells in a fertilized
cow egg that has undergone several divisions. Each of these cells is
then grown into an identical individual, in some cases yielding hundreds
of artificially induced twins, or "natural" clones.

Considering that the public has already been eating meat manipulated by
high-tech means, an open debate might help inform or overcome skepticism
about animal cloning. Such a discussion would require that Americans
have ready access to detailed information about the food they eat.
Industry marketing concerns forbid such full disclosure. We, however,
believe that consumers should have the right to know whether their food
was raised in a way they deem acceptable. Only clear and complete
labeling of all food products, beyond today's incomplete and sometimes
misleading tags, can bring this about--and not just for cloned products,
which might otherwise suffer unjustly in a system where food producers
routinely game the meanings of "organic" and "natural."


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART VI
------------------------------- GENET-news -------------------------------
TITLE:  Dolly's long goodbye
SOURCE: The Ecologist, UK
AUTHOR: Jonathan Matthews
URL:    http://www.theecologist.org/archive_detail.asp?content_id=751
DATE:   15.02.2007
--------------------------------------------------------------------------


Dolly's long goodbye

Jonathan is the founder of GM Watch - www.gmwatch.org - and LobbyWatch -
www.lobbywatch.org.

Four years since the death of Dolly the cloned sheep, her legacy very
much lives on...

Ten years ago this month the world first heard of Dolly the Sheep - the
first mammal cloned from an adult cell. And St. Valentine's Day marked
the fourth anniversary of Dolly's "euthansia" at the age of six after a
veterinary examination showed she had a progressive lung disease, a
condition more common in older sheep.

But this double anniversary doesn't round off the story. Dolly's birth
at the Roslin Institute in Scotland marked just the beginning of a long
production line of animal clones that has included mice, rats, rabbits,
horses, mules, cats and a dog. More ominous perhaps are the cloned
cattle, pigs, sheep and goats. For, while Dolly's stuffed remains are to
be found exhibited in Edinburgh's Royal Museum, the push is on to serve
up the remains of today's cloned livestock on our dinner plates.

Just two months ago a US Food and Drug Administration (FDA)'s draft risk
assessment concluded that meat and milk from adult clones and their
offspring are as safe to consume as those from standard animals. There
has, of course, been no public debate about whether US citizens, let
alone the recipients of US exports, wish to consume such fare, and
surveys of US public opinion show a decided lack of appetite for cloned
food. But we may not have the choice. The FDA has already concluded
labelling should not be required while semen brokers have been busy
selling thousands of units of semen from cloned bulls. Their offspring
are almost certainly going to end up in the food chain. The daughter of
a US cloned cow has already been born on a British farm.

The Biotechnology Industry Organization (BIO) sees no need to worry. A
clone, claims BIO, is just "a genetic twin of that animal... no genes
have been changed or moved or deleted." But clones are far from perfect
copies. All clones are defective, in one way or another, 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.

These often subtle genetic defects can have tangible consequences.
Cloning produces an extraordinarily high number of deaths and deformed
animals. 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. This brings us back to Dolly who developed a potentially
debilitating form of arthritis at an unusually early age.

By that point, the company behind Dolly, PPL Therapeutics, had received
big public funding guarantees, as Dolly became the biotech icon at the
centre of what was supposed to provide Scotland with an emerging
"biotech tartan triangle" and a major economic driver. However, in the
same year that Dolly died, PPL Therapeutics decided to sell its assets
and shut its doors, following multimillion pound losses. It left behind
a large herd of unwanted GM sheep in New Zealand that, like Dolly, had
to be "euthanised".

But still Dolly lives on, not only in the industry of the abnormal that
she gave birth to but as a "cuddly" incarnation of the dream of a world
remade without natural boundaries - limited only by our imagination and
desires. While the dream may be inherently defective, it has powerful
economic drivers. Cloning expert, Peter Shanks, points out that the
FDA's favourable draft assessment of cloned food leaned heavily on the
work of animal-cloning companies like Cyagra and ViaGen. Over a quarter
of the 700-page draft, says Shanks, is a data dump from the two
companies - 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."

For Dolly and her "descendants", it looks set to be a long goodbye.


-------------------- archived at  http://www.gene.ch/ --------------------


                                 PART VII
------------------------------- GENET-news -------------------------------
TITLE:  Wary consumers eye meat, milk from cloned animals
SOURCE: Contra Costa Times, USA
AUTHOR: James Temple
URL:    http://www.contracostatimes.com/mld/cctimes/news/nation/16704652.htm
DATE:   15.02.2007
--------------------------------------------------------------------------


Wary consumers eye meat, milk from cloned animals

WALNUT CREEK, Calif. - When the farming industry embraced artificial
insemination during the 1940s, some critics argued that it would lead to
animal abnormalities or destroy breeding businesses. Others proclaimed
it tantamount to playing God.

Such objections have long since faded away, at least beyond the fringes,
and the technology now is used to produce about three-quarters of all
dairy cattle. To supporters of the Food and Drug Administration's
preliminary approval of food from most clones and their offspring, a
December announcement that sparked wide and vehement protests, the
history of artificial insemination (AI) is telling.

"The information age changes the way that people can fan the flames of
controversy," said James Murray, professor of animal science at the
University of California, Davis, who argues that extensive scientific
research has shown no danger from cloned animals. "This is just AI with
the Internet. It's a storm in a teapot."

Opponents of the FDA's decision, however, point to a more recent
precedent: the agency's approval of St. Louis-based Monsanto Co.'s
synthetic bovine growth hormone (BGH) in the early 1990s.

Consumer groups immediately called for boycotts, and many dairy
processors pledged to reject the drug. In the fourteen years since BGH's
approval, its use has never exceeded about one-third of U.S. cattle.
Recently announced plans to curtail or eliminate BGH by Dean Foods, Wal-
Mart, Kroger, Safeway, Starbucks and other major retailers and
manufacturers promise to squeeze that market share further.

"When Monsanto tried to get the entire dairy industry to embrace growth
hormones, we understood that people who bought our milk weren't going to
want it. The same lesson applies here," said Marcus Benedetti, president
of dairy processor Clover-Stornetta Farms in Petaluma, Calif., which has
said it will not use cloned animals.

On Dec. 28, the FDA said in a draft risk assessment that meat and milk
from adult clones of cattle, swine and goats and their offspring are as
safe to consume as that from standard animals. Therefore, it concluded,
labeling shouldn't be required. (The agency said there is insufficient
information on sheep clones to make a determination on food consumption
risks.)

The FDA is seeking public comment on the subject until April and is
expected to issue a final determination soon after. An agency spokesman
did not respond to repeated inquiries for comment for this story.

The strongest evidence that the products of clones and their progeny
will face difficulty gaining acceptance - that the apt precedent is
bovine growth hormone - are surveys that consistently show that a
majority of consumers hold a negative impression of such food.

"There's no doubt that consumers' aversion to or dislike of cloned
products ... will translate to the marketplace," said Joseph Mendelson,
legal director for the Washington, D.C.-based Center for Food Safety.
"For a variety of reasons, they will reject it."

The most common objections include animal welfare or religious or food
safety concerns. A December 2006 poll by the Pew Initiative found that
64 percent of those polled were "uncomfortable" with animal cloning.
Thirty-six percent felt unsure about the safety of cloned food, and 43
percent said it was unsafe.

"We are putting something out there, and we have no clue what the impact
of it is," said Susanne Scott, a Castro Valley adult school instructor
who falls squarely into the "unsafe" camp. "We're risking future
generations, and we have no idea on what scale."

None of the scientific research into the safety of food from clones has
found any evidence of danger. But some observers, scientists among them,
believe that more research is necessary to adequately answer that question.

Of course, the degree to which consumer preferences affect the adoption
of cloning technology will largely depend on how - and if - the products
are labeled.

There are several forms this could take.

National or state legislators could pass laws requiring labeling of food
products from cloned animals and their offspring. Indeed, last month
California state Sen. Carole Migden, D-San Francisco, and U.S. Sen.
Barbara Mikulski, D-Md., introduced state and federal legislation,
respectively, to do just that.

If such laws don't pass, individual companies opposed to cloning appear
willing to apply labels voluntarily, as happened after the FDA approved
BGH. Clover-Stornetta, which became the nation's first dairy processor
to stamp a BGH-related label on its products, is considering that possibility.

"At the end of the day, the only thing consumers ask for is choice,"
Benedetti said.

Given the soaring interest in natural foods, Mendelson feels that many
manufacturers may pick this route as a means of distinguishing
themselves in the marketplace and that many consumers will keep their
eyes open for such labels.

There also are several practical challenges that will slow the entry of
cloned products into the food supply, at least initially, said Doug
Gurian-Sherman, a senior scientist with the Union of Concerned Scientists.

Because the FDA asked for a voluntary moratorium on animal cloning for
food, there still are no facilities in place to mass-produce clones. At
$15,000 to $20,000 a pop, cloning also is prohibitively expensive.

Because of that cost, even proponents of cloning believe that very few
cloned cows will end up as beef or even dairy cattle. But clones'
descendants could spread relatively quickly. Within four generations, a
single bull whose semen is marketed by breeders can produce more than
100,000 descendants. It remains an open question whether consumers will
react negatively, or even care, about those successive generations.

Cloning is an attractive tool for elite breeders because it is an
efficient means of replicating and spreading preferred genetic traits:
better taste, higher yields, less fat.

Currently, it takes five years to determine whether one bull has the
right genetics to sire daughters capable of producing commercial-quality
milk. Only one in 10 makes the genetic grade. Cloning would allow
breeders to remove the guesswork involved in that process and improve
the genetics of successive herds.

"Where the rubber meets the road is that we're going to have better beef
and better milk," said Barb Glenn, managing director of animal
biotechnology at the Biotechnology Industry Organization, a Washington,
D.C., trade group that represents companies hoping to commercialize
cloning technology.

She said cloning animals that demonstrate natural resistance to disease
could actually make food safer, contrary to the fears expressed in
consumer surveys.

But Murray of the University of California, Davis questions the veracity
of those polls in general. He pointed to a 2001 survey by the Food
Policy Institute and Rutgers showing that half of respondents had a
moral objection to animal cross-breeding. Cross-breeding means allowing
two different purebred animals to mate - think black Lab with golden
retriever - a ubiquitous practice for centuries.

The same survey found that 24 percent of people thought, incorrectly,
that ordinary tomatoes don't have genes but genetically modified ones
do, and that 22 percent believed that tomatoes genetically modified with
genes from a catfish would probably taste fishy.

Murray believes that the cloning surveys reflect a similar lack of
understanding about the technology - stirred up by misleading science
fiction and fearmongering among consumer groups - rather than any deep-
seated dread.

Once consumers become familiar with the concept, supporters say, they
won't have any more problem eating a cloned animal than eating steak
from a twin steer or consuming strawberries, potatoes, bananas or any of
the many other vegetables that are cloned in commercial production.

---

CLONING FACTS:

An animal clone is an exact genetic copy of a donor animal. The cloning
form used most frequently is somatic cell nuclear transfer, or SCNT, in
which the genes of the donor animal are inserted into an egg cell that
has had its nucleus removed. After a few steps in the lab, the egg cell
is implanted in a surrogate, where it usually develops just like any
other embryo.

Using cells from animal embryos to make clones has been done since the
early 1990s, but the first animal cloned from an adult was Dolly the
sheep, which was born in 1996. Livestock species that scientists have
successfully cloned are cattle, pig, sheep and goats. Scientists have
also cloned mice, rats, rabbits, cats, mules, horses and one dog.
Chickens and other poultry have not been cloned.

The farming industry is interested in cloning as a means to increase the
number of breeding animals with naturally occurring desirable traits,
such as disease resistance or higher quality meat. This will allow for
the more rapid spread of those characteristics through the herd.

Plants have been cloned for decades, in a process known as vegetative
propagation. It takes about 30 years to breed a banana from seed, so to
speed time to market, most commercial bananas are clones, as are
potatoes, apples, grapes, pears and peaches.

There are no health complications unique to cloning, but some
conditions, including large offspring syndrome, seem to occur more
frequently in clones. Those problems tend to result in difficult labor
as well as high gestational and post-natal mortality rates. Because of
these and other issues, some consumer groups, including the Union of
Concerned Scientists and Center for Food Safety, believe that more
research is warranted.


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