Cloned Animals May Be Used for Food in U.S., FDA Says

And like the rest of our altered food supplies, labeling won't be required.

The Food and Drug Administration has concluded that milk and meat from cloned animals, such as these cows, should be allowed on the market. That stance has raised a debate over whether food from clones that are raised organically could still carry the organic label. (PRNewsFoto/ViaGen)

Reuters reports:

While the science appears to have come down on the side of the cloning industry, the technology remains controversial, even within the agriculture industry.

Some dairy firms oppose cloning, betting that consumers will shun goods they see linked to cloning technology.

Others believe that more investigation is needed to conclude cloning is safe -- especially after a year in which consumer confidence was marred by numerous food scares -- or oppose it on moral or religious grounds.

"Despite widespread public disapproval, FDA is not planning to require labeling of The U.S. Food and Drug Administration has ruled food from certain cloned animals and their offspring is as safe as other food, opening the door to using the controversial technology in the U.S. food supply.

The FDA confirmed preliminary findings in a final risk assessment on cloning on Tuesday.

"Extensive evaluation of the available data has not identified any subtle hazards that might indicate food consumption risks in healthy clones of cattle, swine or goats," the agency wrote.

The FDA said it did not have enough information, however, to make the same assertion about cloned sheep.

The FDA ruling is the latest twist after years of debate over the reproductive technology, which advocates say will provide consumers with top-quality food by replicating prized animals that can breed highly productive offspring.

The cloning industry, made up so far of only a handful of firms, expects that it will be the offspring of cloned animals, not the costly clones themselves, that would eventually provide meat or milk to U.S. consumers.

There are currently about 570 cloned animals in the United States, but the livestock industry has so far followed a voluntary ban on marketing food from the animals.

It could take four or five years before consumers are able to buy products derived from cloned animals.

products from cloned animals, keeping already wary consumers in the dark," Food and Water Watch, an advocacy group, said in a statement.

Greg Jaffe, director of biotechnology at the Center for Science in the Public Interest, says the cloning industry must now convince the public why cloning is useful.

"Just because the technology is safe, it doesn't mean that as a society there is reason to embrace it," he said.

Jaffe expects Congress or some states may try to impose additional restrictions on marketing or labeling.

The Senate has passed a bill, which must be merged with a House bill and approved by the president, that would delay FDA approval until after more studies are completed.

Several major food companies quickly stated that they are not signing up, at least right away. Tyson Foods Inc, the largest U.S. meat producer, said on Tuesday it has no immediate plans to buy cloned livestock.

The FDA cloning decision comes as biotechnology becomes an ever more important part of global agriculture.

Last week, the European Food Safety Authority made an interim ruling about food from cloned animals and their offspring, saying it was unlikely there was any difference from food derived from traditionally bred animals.

Meanwhile, the BBC reports on the other side of the Atlantic Ocean:

An influential Italian farmers' union has threatened to challenge an EU report that says products from cloned animals are probably safe.

The European Food Safety Authority (EFSA) says it is "very unlikely" that such food is any different from that from conventionally bred animals.

But the Italian farmers' group Coldiretti believes cloned foods would pose an "unacceptable risk".

The Washington Post reports that consumer groups object to FDA approval of cloned food:

Reaction from consumer groups was quick and largely negative today as word spread that the Food and Drug Administration had concluded that milk and meat from cloned farm animals is safe to eat.

The agency's final report, to be released today, makes it likely that food from clones and their offspring will start making its way into the food supply over the next few years.

But opponents, and in particular people and organizations concerned about the health and welfare of cloned animals, raised objections immediately.

"Despite the fact that cloned animals suffer high mortality rates and those who survive are often plagued with birth defects and diseases, the FDA did not give adequate consideration to the welfare of these animals or their surrogate mothers in its deliberations," said Wayne Pacelle, president and CEO of the Humane Society of the United States. "Furthermore, no regulations exist in the United States that protect farm animals during cloning research."

"The Food and Drug Administration's decision to allow the sale of meat and milk from cloned animals leaves consumers at risk and releases another questionable technology into the food supply," added Patty Lovera of Food & Water Watch, a nonprofit consumer rights organization.

The long-awaited FDA report concludes that foods from healthy cloned animals and their offspring are as safe as those from ordinary animals, effectively removing the last U.S. regulatory barrier to the marketing of meat and milk from cloned cattle, pigs and goats.

The 968-page "final risk assessment," finds no evidence to support opponents' concerns that food from clones may harbor hidden risks.

But, recognizing that a majority of consumers are wary of food from clones -- and that cloning could undermine the wholesome image of American milk and meat -- the agency report includes hundreds of pages of raw data so that others can see how it came to its conclusions.

The report also acknowledges that human health concerns are not the only issues raised by the emergence of cloned farm animals.

"Moral, religious and ethical concerns . . . have been raised," the agency notes in a document accompanying the report. But the risk assessment is "strictly a science-based evaluation," it reports, because the agency is not authorized by law to consider those issues.

In practice, it will be years before foods from clones make their way to store shelves in appreciable quantities, in part because the clones themselves are too valuable to slaughter or milk. Instead, the pricey animals -- replicas of some of the finest farm animals ever born -- will be used primarily as breeding stock to create what proponents say will be a new generation of superior farm animals.

When food from those animals hits the market, the public may yet have its say. FDA officials have said they do not expect to require food from clones to be labeled as such, but they may allow foods from ordinary animals to be labeled as not from clones.

The concern that eating products from such animals may be unsafe is not unfounded:

The original cloned animal, Dolly. Suffering from an incurable lung disease, she was euthanized at an early age. She is seen here stuffed and displayed at the National Museums of Scotland. Photo: Trustees of National Museums Scotland

Clones not only don't live as long, but they contract diseases not seen in the 'parent'. There clearly are differences between the original and the clone, and the consumption of clones can't be declared as 'safe' simply because scientists haven't identified any problems in the short term. The only testing that has been done has been on the animals; not on humans who have eaten clones. Without bans or any regulations at all, there is nothing to prevent the industry from introducing cloned products into the food chain without notifying consumers. Currently under consideration is a public relations campaign to "educate" to raise the consumer's "comfort level" (lull the consumer into acquiescence).

Bloomberg reports:

Registering Clones

The major producers of cloned animals, ViaGen Inc. and Trans Ova Genetics, have pledged to register all of their livestock clones so food manufacturers can exclude the animals if they choose, though the program won't apply to the natural-born offspring of replicated animals. Testing for this link is impossible, and it shouldn't make consumers wary of eating meat and dairy products, ViaGen Chief Executive Officer Mark Walton said in a Dec. 19 phone interview.

``If you were to go ask a consumer today if they were concerned about offspring, they would say `Of course I am,''' Walton said. ``When you educate and provide the information and help them understand that progeny and offspring are not cloned, the comfort level goes way, way up.''

Industry groups, including the American Meat Institute, the National Milk Producers Federation, the Grocery Manufacturers Association and the Food Marketing Institute, have said they support registering clones as a way to ease public queasiness.

650 Live Clones

There are now an estimated 650 live clones in the U.S., mostly cattle produced by Austin, Texas-based ViaGen and Trans Ova, of Sioux Center, Iowa. The companies charge about $13,500 to copy a cow, and they expect the clones to be used exclusively for breeding bigger, stronger and perhaps tastier herds.

Cloning allows ranchers to replicate a prize-winning animal or replace one that is injured or aging. About 80 percent of ViaGen's animals so far have gone into the entertainment business as rodeo horses, bucking bulls and show cows. The rest went to ranchers betting the FDA would repeal the voluntary moratorium on sale of food from clones and their offspring.

Senator Barbara A. Mikulski, a Maryland Democrat who has raised objections to cloned food, sent a letter in December to FDA Commissioner Andrew von Eschenbach telling him not to ``pull a fast one'' by acting on cloned foods without conducting additional studies sought by lawmakers.

The Senate included an amendment that would have required more study of cloning in a $286 billion farm bill that awaits negotiation with the House. Congress earlier added language urging the FDA to delay action in an omnibus spending measure signed by President George W. Bush.

The Center for Food Safety has also challenged the agency's review of the scientific data supporting cloned food. The FDA relied on incomplete evidence and misrepresented its findings, the Washington-based consumer group said in a 32-page critique submitted among the public comments.

Call for Hearings

``Congress should hold hearings on the animal-welfare, ethical, and environmental implications of cloning,'' said Gregory Jaffe, director of biotechnology for the Center for Science in the Public Interest, in Washington, in an e-mail today. ``FDA is charged with assessing the safety issues surrounding animal cloning. It is not the agency's job to address other objections that make cloned animals controversial.''

It looks as if we will be unsuspecting guinea pigs.

Too Little, Too Late?

China to Revise Food and Drug Safety Rules



The NYT reports:

Responding to growing international concerns about tainted food and counterfeit drugs, China said late Tuesday that it was overhauling its food and drug safety regulations and would introduce nationwide inspections.

The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and also trying to calm fears that some of its exports pose health problems.

The move follows a series of embarrassing episodes this year involving China’s export of contaminated pet food ingredients and toothpaste. The shipments of tainted pet food ingredients set off one of the largest pet food recalls in United States history.

Last month, an article in The New York Times revealed that at least 100 people had died in Panama after taking medicine containing a toxic chemical called diethylene glycol that had been produced in China and exported as the harmless syrup glycerine.

And in recent weeks, several countries, including the United States, Panama and Nicaragua, recalled or issued warnings about toothpaste made in China because it contained diethylene glycol.

While Beijing has strongly defended the quality and safety of its food and drug exports, and even denied that toothpaste it exported was unsafe, government regulators at the same time have stepped up safety inspections and shut down companies accused of producing unsafe food or counterfeit drugs.

But with pressure growing from regulators in the United States, Europe and other parts of the world, and international food companies expressing concern about the risks of importing Chinese-made food and feed ingredients, Beijing is pushing for a more forceful response to the crisis.

In its announcement on Tuesday, which was posted on a government Web site, China said that the state council had approved a new food and drug safety guarantee system on April 17 and that an outline of the new program was being distributed to government agencies nationwide.

The government said in its announcement that it planned by 2010 to place new controls on food and drug imports and exports, to step up random testing on medicines and have inspection information on 90 percent of all food products.

It said it also planned safety checks on a large majority of food makers and said that regulators would crack down on the sale of counterfeit drugs and medical devices.

The government did not indicate whether it would provide more funds for the efforts or which agencies would carry out the bulk of the functions.

But in announcing the new measures, the government hinted at its weaknesses in enforcement, saying that after five years one goal was that “100 percent of the significant food safety accidents are investigated and dealt with” and that “80 percent of the food that needs to be recalled is recalled.”

A few weeks ago, the government had announced that it was planning to set up a food recall system.

On Tuesday, the General Administration of Quality Supervision, Inspection and Quarantine, which oversees food and drug exports, also posted statements on its Web site about the issue.

“Recently, our country has had a series of export food problems, and that has triggered a lot of overseas attention about China’s food safety,” said Wei Chuanzhong, deputy director of the agency. “This has put us on high alert, and led us to seriously look into the reasons for the problem.”

Food and drug safety experts have complained for years about an incredibly flawed system that has led to food scares or mass poisonings tied to counterfeit or substandard medicines on the market.

Much of the blame has centered on weak enforcement of the nation’s food and drug regulations, as well as corruption, bribery and a business culture where counterfeiting thrives.

China’s food and drug administration, which is supposed to safeguard the nation’s health, has also been implicated.

Last week, a Chinese court handed down a death sentence against Zheng Xiaoyu, the head of the Food and Drug Administration in China from 1998 to 2005, after he pleaded guilty to bribery and corruption. The government also said that he took bribes to approve drug production licenses and that it was reviewing production licenses the agency had issued.

Some experts say the new food and drug safety program suggests that the nation’s top leaders are taking up the call for reforms and new enforcement measures.

“There’s been concern for a while about food safety in this country, and now that there are growing concerns about China’s international image, the state council has decided to act,” said Russell Leigh Moses, an analyst of Chinese politics who is based in Beijing. “This may be a sign that everyone in the government ought to get in line.”

But the challenges facing China are enormous because its regulatory system is weak and enforcement is particularly difficult, partly because the economy is growing so fast and also because local officials accept bribes and sometimes allow small companies to flout regulations.

Also, regulators here say many exporters of food and medicines are mislabeling goods and shipping them illegally.

Two weeks ago, food and drug safety issues were even on the table in Washington during the strategic economic dialogue hosted by Treasury Secretary Henry M. Paulson Jr.

“These are issues China has to deal with over time,” says Rio D. Praaning, secretary general of the Public Advice International Foundation in Belgium, an advisory group that is working on food and drug safety issues around the world. “But we can’t wait. We have interim developments. We have patience, but frankly patience is out the window when people start dying.”

If Democrats really were liberals, and not deregulation-embracing moderate Republicans, they would be using stories like these to teach the American people what good government is all about and what our tax dollars pay for.

It will take China decades before they have in place the food and drug safety inspections that the U.S. had in place before Conservatives took it into their heads to dismantle U.S. government agencies and do away with regulations requiring safety measures and inspections of our food and drug industries. Until then (and until we sweep Republicans out of government and until liberals regain control over the Democratic party), we will dice with death every time we swallow food or medications. That goes for our pets, too.