Fwd: FDA releases misguided report on cloned animals

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" News Update from The Campaign "

FDA releases misguided report on cloned animals

Fri, 31 Oct 2003 06:15:39 -0600

 

News Update From The Campaign to Label Genetically Engineered Foods

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Dear News Update Subscribers,

 

In yet another act of irresponsible behavior, the U.S. Food and Drug

Administration is releasing a report on Friday indicating that meat and

milk from cloned animals is safe to eat.

 

The FDA has not done adequate research to reach this conclusion. They

are making assumptions without data to back it up and apparently

ignoring research that raises many concerns about this experimental

technology.

 

For example, a September 11, 2002, Reuters article discussed research by

Rudolf Jaenisch and colleagues at the Massachusetts Institute of

Technology on cloned rats. Their research was published in the

Proceedings of the National Academy of Sciences. Jaenisch and his team

looked at the placentas and livers of newborn cloned mice and found many

abnormal genes. He reported that almost 50 percent of the " imprinted

genes " involved in the development of the embryo were incorrectly

expressed. Jaenisch stated, " There is no reason in the world to assume

that any other mammal, including humans, would be different from mice. "

 

The Reuters article further stated: " Several cloning researchers have

said their cloned livestock, such as cattle, sheep and pigs, are normal

and healthy if they get past birth. Jaenisch believes genetic

abnormalities will be found even in these seemingly normal animals. Some

of the abnormalities are simply not fatal, he said. "

 

In 1992, the FDA decided that genetically engineered foods are

" substantially equivalent " to non-genetically engineered foods and

therefore need no special labeling. Now the FDA appears ready to rule

that cloned animals are the same as normal animals and again the

American public will not have the right to have labeling.

 

Posted below are three articles. The first is from USA Today titled

" Cloned food gets closer to market. " The second article is from The New

York Times titled " In Initial Finding, FDA Calls Cloned Animals Safe as

Food. " The third is a lengthy front-page article from the Washington

Post titled " FDA Says Cloned Animals Are Safe as Food. "

 

If unlabeled meat and milk from cloned animals gets introduced into the

U.S. food supply, the media is likely to give it a lot of attention -- much

more than they have given to genetically engineered foods. I expect the

beef, poultry, pig and dairy industries will have significant public relations

challenges on their hands. And the trend towards eating a vegetarian

diet is likely to experience a significant growth in popularity.

 

Craig Winters

Executive Director

The Campaign to Label Genetically Engineered Foods

 

The Campaign

PO Box 55699

Seattle, WA 98155

Tel: 425-771-4049

Fax: 603-825-5841

E-mail: label

Web Site: http://www.thecampaign.org

 

Mission Statement: " To create a national grassroots consumer campaign

for the purpose of lobbying Congress and the President to pass

legislation that will require the labeling of genetically engineered

foods in the United States. "

 

***************************************************************

 

Cloned food gets closer to market

 

By Elizabeth Weise, USA TODAY

10/30/2003 10:13 PM

 

The arrival of meat or milk from cloned animals in America's grocery

stores takes a giant step forward today with the release of a Food and

Drug Administration report that says cloned animals pose no greater risk

to human health than normally bred animals.

 

It is the first time that a regulatory body has said that such animals

are safe to eat and greatly increases the likelihood that the FDA will

lift its voluntary ban on the sale of meat, milk and food products made

from cloned animals. In 2002, the FDA asked companies engaged in the

cloning of agricultural animals to voluntarily refrain from selling them

for human consumption.

 

The executive summary of the report is to be presented Tuesday to the

FDA's veterinary medicine advisory committee, which will evaluate it and

eventually consider whether the agency's voluntary restrictions should

be lifted. The FDA has not said when the full 300-page report will be

released to the committee.

 

Industry experts say the sale of products made from cloned animals is

only the first piece of a much larger picture - the sale of " transgenic "

animals. Companies around the globe are already working to genetically

modify animals to produce drugs and all manner of chemicals. And they

anticipate a day when animals might be engineered to produce

extra-tender meat, milk naturally low in lactic acid or eggs that

protect against heart disease.

 

" This sets a basis for the next level, which is transgenics, " says Lisa

Dry of the Biotechnology Industry Organization. " You've got to cross

this threshold before you can go there. "

 

But Greg Jaffe, biotechnology coordinator with the Center for Science in

the Public Interest, says the food-safety evidence is in short supply.

The FDA risk assessment makes numerous assumptions that the public might

not make, he says. The first is that a healthy animal is likely to

produce safe food products, so if a cloned animal is healthy, foods made

from it will be healthy.

 

" The analysis says that if a clone gets as far as the slaughterhouse, it

has to be healthy. And if it's healthy, then it's probably not harmful,

but they don't have the data to back it up, " Jaffe says.

 

The FDA risk assessment also looks at the moral and ethical issues

raised by animal cloning. Clones are subject to many pathological

problems, including hypertension, kidney abnormalities, liver problems,

limb and body wall defects, and abnormally large babies.

 

However, the risk assessment finds that the health problems aren't that

much different from those seen from artificial reproduction technologies

commonly used on farms.

 

Even if the FDA lifts its ban, whether a market will exist is another

matter. The most important issue for the nation's grocers is that

consumers are convinced and assured that the food supply is safe, says

Stephanie Childs of the Grocery Manufacturers of America.

 

It's important to remember that few clones will be sold as food, says

Janet Riley of the American Meat Institute. " It's an exact twin. We're

copying an animal that has optimal characteristics, such as flavor or

tenderness, and using it for breeding stock so that its offspring will

have those characteristics. "

 

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In Initial Finding, F.D.A. Calls Cloned Animals Safe as Food

 

By ANDREW POLLACK

The New York Times

October 31, 2003

 

Milk and meat from cloned animals are safe to consume, the Food and Drug

Administration has tentatively concluded, a finding that could

eventually clear the way for such products to reach supermarket shelves

and for cloning to be widely used to breed livestock.

 

The agency's conclusions, which could face some opposition, are being

released today in advance of a public meeting on the issue on Tuesday in

Rockville, Md. Agency officials said that after receiving public

comments, they hope by late next spring to outline their views on how,

if at all, cloning would be regulated, including whether food from

cloned animals should be labeled.

 

But if the preliminary conclusion stands, labeling would not be needed

and there would be little regulation, Dr. Stephen Sundlof, director of

the agency's Center for Veterinary Medicine, said in an interview.

 

" If we consider them materially the same as traditional foods, the role

for the F.D.A. would be minimal, " Dr. Sundlof said.

 

There are now only several hundred cloned cattle, for instance, out of

the nation's total of about 100 million, so experts do not expect an

immediate influx of food from cloned animals if they were allowed.

Cloning an animal can cost about $20,000, much too expensive to make an

animal just for its milk or meat.

 

" That would make about a $100 hamburger, " said John C. Matheson, a

senior regulatory scientist who led the agency's assessment.

 

Instead, the main use would be to make copies of prized animals for

breeding. The clone would not be sent to the slaughterhouse, but instead

would be used to make many more animals by conventional breeding, and

those animals, the offspring of clones, could enter the food supply.

 

The major safety concern is that cloning results in many failed

pregnancies and abnormal babies, raising the risk that milk or meat from

such animals could be tainted. But the agency said that clones that

survive past early childhood appear to be as healthy as other animals

and food from them should be safe.

 

Still, any move to allow food from cloned animals or their offspring is

expected to face some opposition. Some critics say the evidence of

safety is not sufficient. Even the agency concedes its conclusions are

based on somewhat scanty data, particularly for animals other than cows.

Other critics raise questions about the ethical implications of cloning,

and its effects on animal welfare and farming.

 

" I think it warrants a discussion that goes beyond the narrowest

scientific issues, " said Carol Tucker Foreman, the director of food

policy at the Consumer Federation of America.

 

Ms. Foreman said polls had shown that American consumers were ill at

ease with animal cloning. " When you say `animal cloning,' many people

react as if you are at least opening the door to human cloning, " she

said.

 

Some food companies are also cautious, worried that such food, even if

safe, might be shunned by consumers. That has happened to some extent

with genetically modified crops.

 

" It's fine to get the stamp of approval from the F.D.A. but we also need

to get the stamp of approval from consumers, " said Kathleen Nelson,

senior director for legislative affairs at the International Dairy Foods

Association.

 

Ms. Nelson said that while biotechnology offered benefits for the food

industry, the Food and Drug Administration needed to build " a strong and

impressive body of science on the safety of the products. "

 

Cloning involves using a cell from an animal to make a nearly

genetically identical copy of that animal. Dolly the sheep, the first

clone of an adult mammal, was born in 1996. Since then, cows, pigs and

horses, among others, have been cloned.

 

But the regulatory status of food from cloned animals has been in limbo.

In June 2001, the agency asked cloning companies and farmers to keep off

the market voluntarily the milk and meat from clones, and from the more

conventionally bred offspring of clones, so it could assess the

potential risks.

 

That has contributed to financial struggles for the handful of small

companies hoping to make a business out of cloning. And it has

frustrated a few farmers and breeders who own clones. They have to

dispose of milk from cloned cows and cannot sell semen from cloned

bulls.

 

" You milk it, you dump it, " said Karyn Schauf, owner of Indianhead

Holsteins, a breeder and dairy farm in Barron, Wis., that has two clones

of a now-dead prized dairy cow but cannot sell the clones' milk. " Not

being able to treat them as regular animals really puts a cap on their

value. "

 

Donald P. Coover of Galesburg, Kan., who sells semen for breeding, has

been freezing semen from some clones of an Oklahoma bull named Full

Flush, waiting for the voluntary moratorium to end. He said that this

year alone he sold $100,000 worth of semen from Full Flush, enough to

inseminate 2,000 cows. With that kind of profit, Mr. Coover said, it

made sense to make clones of Full Flush to provide even more semen, and

to carry on providing the semen after the original animal dies.

 

Smithfield Foods, a leading pork processor in Virginia, has an agreement

with ViaGen, an animal cloning company in Austin, Tex., to explore the

use of cloning for breeding.

 

Some experts say a major use of cloning will be to help make genetically

engineered animals, like those that can produce pharmaceuticals in their

milk, or those with genes to make them disease-resistant or their food

more nutritious.

 

The F.D.A. safety analysis did not look at genetically engineered

animals, whether produced using cloning or not, only at clones that are

copies of conventional animals. Genetic engineering introduces

additional risks and the agency wanted to tackle the simpler issue of

cloning first, officials said.

 

The agency is releasing an 11-page summary today of a larger risk

assessment it hopes to publish in the coming months. In its analysis, it

assumed that obviously malformed animals produced through cloning would

be rejected as sources of milk or meat. That left the question of

whether there could be more subtle abnormalities that might, for

instance, change the nutritional quality or safety of the meat or milk.

 

The agency said that did not appear to be the case. It reached its

conclusion based on studies in journals and on tests of the composition

of the blood and milk of clones.

 

The agency saw no problems with the safety of the conventionally bred

offspring of clones. The genetic problems thought to cause the

abnormalities in some cloned animals do not carry over into the next

generation, it said.

 

The agency also looked at the effects of cloning on animal welfare and

found there were some health problems. Still, the agency said, the

problems were not that much different from those caused by other

techniques used in farm breeding, like in vitro fertilization.

 

***************************************************************

 

FDA Says Cloned Animals Are Safe as Food

 

By Justin Gillis

Washington Post Staff Writer

Friday, October 31, 2003; Page A01

 

Cloned farm animals and their offspring pose little scientific risk to

the food supply, the Food and Drug Administration has concluded in a new

report that could pave the way for allowing products derived from clones

or their offspring onto the nation's grocery shelves.

 

The draft report, to be released in summary form this morning and

discussed at an FDA advisory committee meeting next week, is likely to

kick off a fresh national debate about just how far to go in

manipulating nature to achieve human ends. Nearly a year behind

schedule, the report moves the agency closer to a formal declaration

that cloning, the technology that produced Dolly the sheep, is

permissible as a routine tool of American agricultural production.

 

If clones survive into adolescence, " the animals themselves appear to be

healthy. And it's hard to imagine that healthy animals would somehow be

capable of producing unsafe food, " said Stephen F. Sundlof, director of

the FDA's Center for Veterinary Medicine, which prepared the report. " No

scientist I've talked to can come up with any rational theory of how

that could possibly occur. "

 

Some farmers and a handful of companies have been eager to exploit the

potential of cloning, and some cloned animals -- most estimates put the

number at 200 to 300 -- are already living on American farms. No federal

rule prohibits sale of food products derived from clones or their

offspring, but the FDA has informally asked producers to hold off, which

they say they have done. A few farmers are even pouring out milk from

cloned Holstein dairy cows. That voluntary moratorium will stay in

effect for at least the next several months, the FDA said.

 

Despite repeated scientific assurances, food manufacturers and consumer

groups are nervous about the technique, believing the public just isn't

ready for cloned milk in the refrigerator or cloned hamburgers on the

grill. This " yuck factor, " as one consumer advocate calls it, could pose

political problems for the Bush administration, since it looks

increasingly likely that the FDA will give a green light to cloned food

as the 2004 election enters full swing.

 

" What a perfect time for the FDA to put out a report on cloning, on

Halloween, " declared Carol Tucker Foreman, director of food policy at

the Consumer Federation of America, in Washington. " Most Americans find

it pretty scary. "

 

Organic food advocates and animal welfare groups say animals will suffer

unnecessarily if commercial interests push cloning technology into

routine food production. And some people are starting to worry that a

large commercial market in cloned animals could spur development of more

sophisticated cloning techniques, hastening the day when human

reproductive cloning can no longer be ruled unethical on safety grounds,

as it has been so far.

 

As of yet, these forces have not converged into a strong movement

against animal cloning. The FDA, hoping to spur public discussion, made

its new report available early to a handful of news organizations. The

report said that emerging research, though thinner than the FDA would

like, suggests that while there may be genetic differences between

healthy looking adult clones and ordinary animals, these are likely to

be trivial.

 

" Edible products from normal, healthy clones or their progeny do not

appear to pose increased food-consumption risks relative to comparable

products from conventional animals, " the report said.

 

Clones still cost about $20,000 apiece to produce, so it's highly

unlikely any of them would be eaten directly as food, at least in the

next few years. Instead, farmers want to clone elite animals and use

them as breeding stock to upgrade the genetics of entire herds. Milk

from cloned cows and meat from the first- or second-generation offspring

of cloned cows and pigs are the likeliest products to enter the food

supply in the near term.

 

The FDA report said animal cloning does pose increased risks to the

animals themselves, and to the surrogate mothers who give birth to them.

The technology is plagued by high failure rates, spontaneous abortions

and severe health problems in many clones and their mothers. But the

report said these problems are no different in kind from the animal

welfare problems caused by other reproductive technologies, such as

artificial insemination or test-tube fertilization, that have been in

use on American farms for decades.

 

Cloning problems are worse in some species than others -- they are

notably severe in cows, the prime targets for firms working on

commercial cloning -- but the difficulties are gradually lessening in

all species as the technology improves, the FDA said. And the report

said once cloned animals survive the critical first weeks after birth,

their health seems to stabilize and it is hard to tell them from normal

animals. Though most clones have yet to reach prime reproductive age,

several have produced healthy offspring.

 

Concern about cloning is not confined to the most assertive animal

rights groups. The technique has drawn sharp opposition from such

organizations as the Humane Society of the United States. A panel of the

National Academy of Sciences, the nation's premier scientific body, said

last year that animal welfare was a serious concern, while also

declaring that the cloned food was almost certainly safe to eat.

 

No federal law or policy appears to give government power to stop

cloning on grounds of animal welfare, much less because the public might

have aesthetic or ethical problems with it. Taking such concerns into

account might require new legislation, and the biotechnology industry,

with which the Bush administration is closely allied, has vigorously

fought expanded oversight by the FDA or other agencies.

 

" We look forward to an expedient decision from FDA that allows livestock

producers and biotechnology companies to begin marketing their

products, " the Biotechnology Industry Organization, a Washington trade

group, said in a statement last night.

 

Foreman, the consumer food policy expert, called on the Bush

administration to submit the ethical questions for broad public

discussion, perhaps in hearings before a presidential commission already

studying related issues. She and other consumer advocates largely accept

the scientific view that cloned food would be safe but say that

shouldn't be the end of the discussion.

 

" I think many people think it's the first step down a slippery slope, "

Foreman said. " I won't defend that position, but when Dolly was cloned,

immediately the discussion went straight to issues of human cloning. I

suspect that will happen again. "

 

The FDA plans to publish a more detailed version of its report this

spring, then seek public comment before finalizing any national policy.

But, barring some dramatic new scientific finding, the agency appears

likely to conclude that cloning is safe and it therefore has no power to

regulate.

 

Even as the discussion has unfolded in Washington, American

entrepreneurs have been pushing the technology forward. The nascent

cloning industry has been roiled by uncertainty about the FDA's position

and by the stock market downturn, with some small companies going under,

but a handful of labs are still offering cloning services. Cyagra Inc.

of Worcester, Mass., is the biggest, charging $19,000 apiece to clone 50

to 60 animals a year. The firm has returned more than 100 clones to

American farmsteads, said Steve Mower, director of marketing.

 

Most farmers haven't embraced cloning yet, but quite a few that own

champion farm animals are hedging their bets. Cyagra offers to store

cells from prized animals so clones can be produced any time, and

farmers have already put more than 500 animals into deep freeze.

 

 

 

 

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