Cloning Remains a Meaty Issue (Full Article)f2
By Kristen Philipkoski of Wired News
02:00 AM Oct. 15, 2003 PT
The Food and Drug Administration soon will decide whether the meat in your Philly cheese steak or your barbecue spareribs could come from a cloned animal.
Because of safety concerns, the FDA has barred the handful of companies that clone farm animals from selling them for meat. But since early this year, those companies have been submitting data -- generated by independent research firms -- to the FDA.
The specifics of the data will remain confidential until Oct. 20 when the FDA plans to post the research online for public review. But the majority of companies say that, in general, the research shows no significant difference between regular and cloned animals, suggesting that cloned meat would be perfectly safe for human consumption. Consumer watchdog groups are skeptical, and say cloned meat should at least be labeled.
The FDA will hold a public meeting on the topic Nov. 4 at its Center for Veterinary Medicine in Rockville, Maryland.
Studies have shown differences between cloned and regular animals, including a higher incidence of genetic and physiological abnormalities in clones. But scientists say these differences don't pose a threat to someone who eats cloned meat.
"It's up to the FDA to determine (whether cloned meat is safe), but our research shows no material difference between non-cloned animals and cloned animals," said Ray Page, chief scientific officer of Cyagra, an agricultural cloning company and a recent spinoff of Advanced Cell Technology.
"All of the clones we have looked at, at ViaGen and Prolinia (a subsidy of ViaGen), have appeared to be just like normal animals," said Scott Davis, president of ViaGen, an animal genetics company.
A 2002 National Academy of Sciences report said there was no evidence that cloned meat was dangerous to eat, but more data was needed to be certain.
The genetic differences in clones arise mainly during the development of the embryo and are negligible by the time the cow is ready for slaughter or milking, said Eric Hallerman, an associate professor at Virginia Tech who co-authored the study.
"Scientists are unanimous (as far as I know) that (cloned animals) are indeed safe," said Michael West, CEO of Advanced Cell Technology, in an e-mail. Researchers at the company published a paper in Science in November 2001 titled, "Cloned Cattle Can Be Healthy and Normal."
It costs $19,000 to have your favorite cow cloned by Cyagra. The more you clone, the cheaper the procedure becomes: Six clones cost $72,000. Discount or no, it would not be practical for farmers to clone all their cattle rather than breed them normally.
But Cyagra and other companies that clone animals say cloning select cattle can promote strong, disease-free genes in the clones' progeny. A farmer might want to clone a particularly productive dairy cow, or a very healthy steer. Cloning eliminates the trial and error inherent in regular breeding.
Only about 1 percent of a herd would be clones, and it's not likely they'd be first to the slaughter, researchers say.
"I think the issue is essentially irrelevant because you're not going to be eating the cloned animals," said Robert Lanza, vice president of medicine and scientific development at Advanced Cell Technology. Lanza said he believes that if the FDA determines cloned meat to be safe, consumers still would be able to choose whether or not to eat the cloned products.
John Matheson, the FDA toxicologist in charge of determining any risks that might come from eating cloned meat, said if the agency finds cloned meat is as safe as conventional meat, it won't require companies to label the products.
But watchdog groups say health problems could evolve over time, and consumers should know if they're eating a clone.
"Certainly I think there should be labels," said Joseph Mendelson, legal director of the Center for Food Safety. "I think overwhelmingly consumers would want that information and I think there's reason to give it to them."
Public reaction to genetically modified foods in the United States is significantly milder than in Europe, where protests, some violent, are much more prevalent. But Mendelson said that's because most Americans are unaware that they're already eating genetically modified organisms.
One FDA focus group found that when Americans learned this fact, they were amazed and outraged.
But whether consumers want the information isn't the FDA's main concern. Rather, the agency must determine what risks exist and then decide how to manage them. Matheson said he hopes to achieve the first part of that goal at the Nov. 4 meeting, and the management part by January 2004.
Animal welfare is another concern. In cattle, from 10 percent to 50 percent of cloned embryos become healthy cows. The numbers can be much lower in other animals, and animal rights groups protest the fact that many clones that don't survive to adulthood are born sick and malformed.
The 2002 National Academy of Sciences report was more concerned about the environmental impact of cloned animals than the potential health effects upon people who might eat clones. The scientists said the potential for cloned or genetically engineered animals to escape into the wild is worrisome.
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U.S. chemical regulation leaves much unknown (Full Article)f3
Europe wants more tests. Industry sees big costs.
By Tom Avril
Inquirer Staff Writer
Without requiring lab tests to determine their safety, the U.S. government has approved thousands of chemicals for use in such products as sofa cushions, soaps, paints and baby bottles.
On average, two more chemicals are approved every day.
The result: Consumers are unwittingly part of a vast, uncontrolled lab experiment.
"We're treating [people] worse than lab rats," said Karen Florini, a lawyer with the nonprofit group Environmental Defense. "At least with lab rats, somebody bothers to collect the data."
The U.S. system of regulating chemicals is under renewed scrutiny after European officials voted last week to adopt tougher rules that would require substantial testing of many substances before they could be sold there.
As growing amounts of synthetic substances are found in human breast milk and blood, U.S. critics want similar rules here.
Chemical-makers counter that the European proposal would cost billions of dollars, stifling research in an industry whose products are overwhelmingly safe and perform valuable functions. With support from the Bush administration, the companies favor a voluntary approach to testing.
Aside from saving time and money, conducting fewer tests on lab animals also means less criticism from animal-rights groups.
As the debate continues, new concerns emerge regularly: Polybrominated diphenyl ethers, used as flame retardants, have been linked to brain damage and lower fertility in lab animals. The amounts in human breast milk in the United States are doubling every two to five years, in some cases nearing levels linked to health problems in animals.
In a rare move yesterday, the chief U.S. maker of two such chemicals agreed to stop making them by the end of 2004.
Bisphenol A, used in baby bottles, dental sealants, and linings of food cans, has been tied to lower fertility in rats and defective chromosomes in mice eggs.
Perfluorinated compounds, used to make Teflon and formerly Scotchgard, have been found in human blood and breast milk. Some members of this chemical family, though not Teflon, have been linked to cancer in lab animals. Human risks are unclear.
Methyl tertiary-butyl ether (MTBE), a gasoline additive that reduces air pollution, readily infiltrates groundwater because of its high solubility. It is linked to cancer in mice and is labeled a potential human carcinogen.
With most chemicals, there is no proven risk to humans, and manufacturers often sponsor research that contradicts findings of possible risk.
And in most cases, that's the end of the story.
Even if health concerns are raised after a chemical is on the U.S. market, the government often does not require that it be tested in any systematic way.
And manufacturers can continue making it for years.
When companies do come across possible risks, they must submit data to the U.S. Environmental Protection Agency. But companies can - and for most new chemicals, do - claim the information is confidential.
As a result, the information is never available to the public.
This system for screening chemicals, enacted 27 years ago, allowed continued production of the 62,000 chemicals then in use and required little, if any, lab testing for the 18,000 approved since then. (Other laws govern chemicals in pesticides, food and drugs, which do require tests.)
Although criticized now, the Toxic Substances Control Act was seen in 1976 as a big improvement, said a lab technician at DuPont's Chambers Works plant in Deepwater, Salem County.
"They used to put 'XYZ' on the drums," said Corliss Sheppard, former leader of Local 2-943 of the Paper, Allied-Industrial, Chemical & Energy Workers union. "You couldn't even say what it was. We were tickled to death to at least make them have to tell us what it was."
Difficulties in implementing the law soon became apparent.
The EPA has the power to require testing of any chemical, old or new, that it believes may pose a "reasonable risk" to human health or the environment.
Yet the burden of demonstrating risk lies with the agency, a lengthy process that involves estimating exposures for each way a substance might be used. The agency rarely requires tests through this process. More often it negotiates with companies to conduct tests.
A 1997 EPA study found that of the 3,000 chemicals imported or produced in the United States in amounts above one million pounds, 43 percent had no publicly available data on toxicity.
Just 7 percent had a full set of basic data, which includes information on how long a chemical persists in the environment and its short- and long-term impacts on the health of lab animals.
Soon after the study, manufacturers volunteered to test these high-volume chemicals, an effort that is ongoing. Industry officials say they already had some data for most of the high-volume chemicals, though they concede it was not publicly available.
"This allegation that these chemicals haven't been evaluated isn't necessarily accurate," said Steve Russell, a lawyer for the American Chemistry Council, an industry group.
Moreover, Russell said, most of the 80,000 approved chemicals are not made in significant amounts. Council officials estimate 15,000 chemicals are actively made, but they could not provide an exact figure, nor could they say how many have been tested.
If requiring tests is hard, restricting a chemical's use is harder.
To take such action, the EPA must determine that any risks are not outweighed by a substance's economic and societal benefits, again for each way in which it might be used.
In practice, this provision is so difficult and expensive to implement that it is rarely used.
Even with asbestos, a substance known to cause a rare lung cancer, the EPA spent a decade documenting the risks but ultimately could not make a proposed ban stand up in court.
Restricting new chemicals is easier, through a 90-day screening process. Using computer models, the EPA predicts which new chemicals may be harmful by comparing their structures with those of existing substances. But again, safety data on the old chemicals can be limited.
In a handful of cases, manufacturers have volunteered to stop making chemicals. In 2000, 3M agreed to phase out a chemical used in Scotchgard. Yesterday, Indianapolis-based Great Lakes Chemical Corp. agreed to phase out two flame retardants by the end of next year.
California previously banned the two flame retardants as of 2008, and a European ban on them takes effect next year. Great Lakes also announced a replacement product for use in furniture. The replacement, dubbed Firemaster 550, has been voluntarily submitted for an unusual EPA review.
Officials declined to reveal the exact chemical name or structure but said it was not in the same family as the original products. EPA officials said that the new substance did not appear to be toxic but that they would monitor future tests.
A representative of flame-retardant makers maintained there was no risk from the old varieties.
"Just detecting something in the environment doesn't mean it's going to have any effect on human health or on animal health," said Peter O'Toole, U.S. program director for the Bromine Science and Environmental Forum.
Critics counter that evidence of harm will be elusive without required testing.
"How do you know?" said Joel Tickner, an occupational-health professor at the University of Massachusetts in Lowell. "Unfortunately, the lack of proof of harm is very often misinterpreted as proof of safety."
That may change in Europe. On Wednesday, the European Commission voted to require various tests on more than 10,000 chemicals, depending on the amounts produced. Other data are required on 20,000 more. Final approval of the proposal could take two years.
The commission estimates the direct cost to chemical makers at $2.7 billion. Other companies that use chemicals in their products would likely spend billions more. Industry officials say the costs would be higher.
Upon evidence of potential risk, Europe could restrict or ban chemicals without waiting years for proof, a concept known as the precautionary principle.
Proof of risk is a high hurdle, one cleared by only a handful of substances to which humans are exposed at significant levels. Some scientists think the evidence against polybrominated flame retardants, for example, is headed in that direction.
How the chemicals enter the body is unclear. What is not in dispute is that the chemicals are persistent, meaning they do not break down in the environment for years, even decades.
All the more reason to play it safe, Tickner said.
"If we wait until we have perfect data on the chemicals," he said, "and we're wrong [about their safety]... then you deal with them for a long time."
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