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Press Coverage Story
FDA to Rule on Sales of Clones' Products.
By Jonathan D. Rockoff, Baltimore Sun
October 02, 2005
WASHINGTON // The federal government is nearing a decision to allow the sale of meat and milk from cloned cows and their offspring, according to officials from government, industry and consumer groups.
The Food and Drug Administration is expected to take a major step toward approval soon, proposing to permit the sales, subject to 60 days of public comment and additional review.
That could lead to choice cuts of steak and cartons of milk produced from cloned cattle landing in kitchens over the next several years.
Given the high cost of cloning, industry officials and consumer advocates say that it's more likely that consumers would be sold the meat - if not the milk - of offspring of cloned cattle, not of the clones themselves.
"You're not producing them to eat - you're producing them to breed," said Scott K. Davis, president of Start Licensing, a joint venture of biotechnology companies that own the licenses for cloning livestock. He said cloning a cow would cost $15,000.
Even after the FDA reaches a final decision, livestock producers will need up to four years or more to raise offspring ready for slaughter, and most dairy farmers may ignore the technology until the cost falls, their trade groups said.
Once approval comes, however, industry and consumer groups are concerned that a public backlash will follow. Scientific studies support the safety of the food products, but surveys indicate that many Americans remain jittery or harbor ethical concerns.
"A train wreck is coming," said Carol Tucker Foreman of the Consumer Federation of America. "It's not about the science. It's how people see their food."
Some consumer advocates and dairy companies have urged regulators to delay a decision until those fears can be calmed. Yet with the accumulation of studies supporting the food's safety, the FDA has edged toward approval.
The FDA had said an announcement was likely within the next few weeks, but the recent surprise resignation of FDA Commissioner Lester M. Crawford might delay it until the end of the year, or even longer, according to industry and consumer groups. The decision would represent one of the first major acts by acting FDA Commissioner Andrew C. von Eschenbach.
When the FDA makes an announcement, the agency said, it will release the draft of a report on the safety of eating and drinking from cloned animals and, in all likelihood, tentative rules governing the sale of the foodstuffs.
"We're well aware that there are many social and ethical issues related to the cloning of animals," Crawford said at a Sept. 19 food conference.
It is a measure of the government's sensitivity on the issue that the FDA is also considering publishing a paper in a scientific journal that would mention the moral and ethical concerns surrounding the decision. That would be a departure from the agency's scientific mission.
Plans to White House
According to industry officials, the FDA has also sent its plans to the White House for approval by President Bush's aides.
"It hasn't been a safety issue that is holding this up. It is a concern about the public reaction," Michael Rodemeyer, former executive director of the Pew Initiative on Food and Biotechnology, said at the same conference where Crawford spoke.
The FDA said its ruling will encompass cloning of goats, pigs and sheep, as well as cows.
Many livestock producers support approval because cloning increases the odds that it will yield beef with the grade, marbling and other qualities that fetch the highest prices and provide the best taste and tenderness.
Leah Wilkinson, director of food policy at the National Cattlemen's Beef Association, said she expects the beef to be sold in supermarkets, though how widely it will be marketed will depend on the cost and the speed with which producers use the technology.
Since 1997, Americans have been eating processed foods made with genetically modified vegetables, such as corn and soybeans. But many consumers regard goats and pigs differently from canola and squash, polls show. Also, talk of cloning prompts fears straight out of science fiction movies.
A national survey last year by the Pew Initiative found that 57 percent of those polled opposed scientific research into the genetic modification of animals. Often, the reason cited was a fear of humans playing God, even among those who are not very religious.
"People fear ... we're beginning to go down a road and we don't know where it's going and what the consequences will be," Rodemeyer said.
Sanford A. Miller, former director of the FDA's food safety office, said research hasn't raised safety concerns.
"As far as we can tell, there doesn't seem to be a difference" between food from cloned animals and conventionally bred animals, said Miller, who served on a National Academy of Sciences committee that studied animal cloning.
William K. Hallman, a Rutgers University professor who has received federal funding to study public attitudes, said Americans know so little about the technology that their reaction might hinge on how the FDA and industry handle its introduction.
"If people understand why - what's the problem being solved - they're much more receptive," he said.
Anxiety over the application of new technologies to food is nothing new. Some parents, for example, still balk when schools intend to offer irradiated meat, even though irradiation cuts down on foodborne illnesses and the federal government has approved it.
Genetically modified food, in particular, has raised hackles. Monsanto, a leader in agricultural biotechnology, shelved plans to sell transgenic wheat last year and withdrew genetically engineered tomatoes from the market in 1994 partly out of concern that consumers would reject what critics call "Frankenfoods."
Industry officials pin their hopes for public acceptance of food produced by cloning on two institutions.
Through the news media, they hope to portray the introduction of cloning as the latest evolution in years of advances in breeding - just a step up from artificial insemination and in vitro fertilization.
"Cows frolicking in the pasture aren't how they reproduce today," said Lisa Dry, spokeswoman for the Biotechnology Industry Organization.
Industry officials also hope that the imprimatur of FDA approval will ease consumer concerns. In March, a poll sponsored by the International Food Information Council, which is financed by food, beverage and agricultural companies, found that support of food from cloning would more than double - to 34 percent - if the agency ruled it is safe.
The National Milk Producers Association has urged the FDA to issue a clearly worded announcement and help educate consumers.
"So much of this is going to be a matter of semantics," said Christopher W. Galen, spokesman for the trade group, which represents dairy farmers and marketing cooperatives. "We want an emphatic statement."
In 2003, the FDA first weighed in on the issue, releasing a brief and preliminary report. It said that food from clones and their offspring didn't pose any more of a safety risk than the products of naturally born animals
Until a final decision is announced, the agency asked farmers to keep the products from clones and their progeny off the market.
There are a few hundred cloned cattle among the 100 million in the United States, industry groups say.
Gathering support
In the two years since issuing the preliminary report, the FDA said it has gathered more than 100 scientific studies, as well as unpublished articles, supporting its earlier finding.
Although the agency seems close to reaching a decision, many observers don't expect the issue to subside soon. One fight might be over labeling.
Some consumer advocates want products of cloned animals and their offspring labeled. But the FDA wouldn't require labels unless it found that food derived from clones was not as safe as, or materially different from, food from naturally born animals. Studies don't indicate such a difference.
Some companies, nevertheless, might try to issue their own labels, indicating that their products aren't genetically modified. Companies selling products from clones would resist, arguing that the voluntary labels might give a misleading impression that food from clones isn't safe.
"And FDA would be watching that as well," said David B. Schmidt of the International Food Information Council, making the point that the agency might have a role after it reaches a final decision policing false claims on labels.
jonathan.rockoff@baltsun.com
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