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Does the FDA Have a Hidden Agenda?

They Want You to Eat Cloned Meat–and They Don’t Want You to Know It


The Food and Drug Administration (FDA) is close to letting into our food supply meat and milk from cloned livestock and their offspring. This is a really bad idea, and worth complaining about; they have asked for comments. An easy way to send them in is by going to the site set up by the True Food Network. The final decision will not be made until the beginning of April.

The FDA claims that cloned meat and milk are safe, in fact so much like ordinary meat and milk that they need not be checked or labeled. This assertion has been demolished by Denise Caruso of the Hybrid Vigor Institute in the San Jose Mercury News, and by Dr. Mae-Wan Ho and Prof. Joe Cummins of the Institute of Science and Society, among others. Basically the FDA did not see any risk because they did not look where they might find it.

Nine out of ten clones don’t even make to birth; many that do, die soon afterwards. A few do grow up and superficially appear normal, but experts suggest that they never really are. MIT’s Rudolf Jaenisch put it succinctly in Time last year:

"If you reprogram, it affects the whole genome. From what we know, I would argue that cloned animals cannot be normal. They can be closer to normal, but not normal."

But by the FDA’s proposed rules, if a cloned animal looks OK to a farmer, then that marketable asset can be milked, mated or slaughtered without further concern. If it looks seriously ill, then it is subject to current regulations, but no more than that. And the offspring of cloned livestock mated with normal partners are assumed — note, assumed — to be healthy.

One particularly dubious aspect of the FDA’s logic is their assertion that a "side effect" that occurs very rarely in nature, but vastly more often in a cloned or genetically engineered organism, is still somehow a "natural" byproduct. If something ever happens naturally, even once, then it cannot be considered unusual no matter how often it occurs under artificial circumstances. This is absurd, and the data that follow to illustrate this are in their own Risk Assessment, a 4.24 MB pdf linked from here.

Many clones, especially of cattle, suffer from Large Offspring Syndrome (LOS), meaning they are born at least 20% bigger than usual. LOS is associated with many harmful traits, such as a weak or absent suckle reflex, deformities, poor organ development, increased susceptibility to infection, enlarged heart &/or failure of lungs to inflate. In 12 studies collected by the FDA, 232 of 388 calves had LOS (60%), and 166 died (from Table V-4 on pp. 119-120). LOS does happen without cloning, though only when the embryos have been created in vitro, or the mothers are deliberately fed an experimentally poisonous high-nitrogen diet. The FDA uses this skimpy rationale to claim that "no adverse outcomes have been noted in clones that have not been observed in animals derived via other ARTs or natural mating" (p. 306).

But LOS is still a little-understood and often lethal abnormality that, by the FDA’s own report, occurs twice as often in cloned calves as in IVF-produced ones where the embryos are fertilized with sperm — and rarely if ever after "natural mating." Something is going wrong on a deep genetic level, so wrong that the poor surrogate mothers often have to suffer caesarians and may even die. It is simply not a valid argument to say that we should ignore this problem because other factors can produce it, especially when cloning makes it so much worse.

There are many more reasons to be concerned. For those seeking more information, the Center for Food Safety (CFS) has compiled a helpful pdf fact-sheet and is also using MySpace, BlogSpot and YouTube to spread the word, as well as their own website and the related True Food Network. CFS is pressing the FDA with a combination of grassroots activism (along with Ben and Jerry’s) and a lawsuit, in which it is joined by:
Consumer Federation of America
Food and Water Watch
Friends of the Earth
The American Anti-Vivisection Society
The Humane Society of the United States
The Religious Coalition for Reproductive Choice
The Center for Environmental Health

The Organic Center has weighed in with a dispassionate analysis of the FDA’s report (a 1.2 MB pdf, linked from here). They clearly oppose this use of cloning technology, which is not allowed under organic standards, though they note dryly that:

The presence in the marketplace of unregulated and unlabeled meat and milk from cloned animals will help further differentiate organic products from unsegregated conventional livestock products. This will almost certainly increase demand for organic meat and animal products.

You don’t have to be vegan, or vegetarian, or even someone who insists on eating organic out of concerns about hormones or pesticides, to be concerned about clones. You don’t have to be an animal-rights activist to want to minimize the cruelty inflicted on livestock. In fact, all the polls show that huge majorities are against cloned livestock, including a whole series from Gallup and most recently one from the Pew Initiative on Food and Biotechnology.

Meanwhile, the January 2007 issue of Nature Biotechnology published the results of a massive global survey coordinated by the European Commission’s Joint Research Centre, which revealed that the livestock industry itself regards the commercial prospects of cloning as poor, except perhaps for elite male pigs. In other words, the potential benefits are tiny, so any cost at all (including concerns about safety, cruelty or social effects) has a relatively large effect on the cost/benefit assessment equation.

Still, James Greenwood, former Congressman and current CEO of the Biotechnology Industry Organization (BIO), remains an uncompromising supporter, telling the Bucks County Courier Times on February 5th (no longer free online) that:

"I don’t think there are any ethical issues whatsoever. We’re not talking about human beings here, we’re talking about cows and pigs. Just because you’re cloning cows and pigs doesn’t mean you’re going to be cloning human beings."

Human reproductive cloning may well never happen, because the technology is so error-prone, but preparing the public for other kinds of human genetic interventions may be the real point of this exercise, as pointed out (by me) at the Biopolitical Times blog.

Elite opinion is somewhat divided on this issue. Some of the reporting has reflected an unquestioning acceptance of the FDA’s risk assessment, but several bills are being introduced, at both federal and state level, to require labeling of cloned products. (If they fail, and the products appear, expect to see competing "clone free" labels.) The New York Times came out against cloning livestock, with a notably insightful editorial:

"Asking whether cloned meat and milk are safe is not even the right question. The right question is, why clone at all? … Are we willing to judge the suitability of new technologies in ways that fully address their ethical and biological complexities? Or are we doomed to give in to politics and the bottom line?"

Livestock cloning is unneeded, unwanted, and quite likely unsafe. If you want to keep cloned animal products out of our food supply, please tell the FDA now. Will your comments really make a difference? They might: A powerful head of steam is building up to stop or at least slow this approval. And even if the FDA presses ahead, a large outpouring of public complaint now could be important for the future, when there will be more and more decisions to be made about commodifying not just plant and animal but human life through biotech. This is an opportunity to lay down markers about what is and is not acceptable.

You can write to the FDA directly, at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD, 20852

You can also submit comments electronically via their website, but the interface is confusing. As of early February, this was on the sixth page of their comments section; you can search by Docket Number, which is 2003N-0573. It’s simpler to use the form set up by the Organic Consumers Association.

PETE SHANKS is a grassroots activist who lives in Santa Cruz, California, and wrote Human Genetic Engineering: A Guide for Activists, Skeptics, and the Very Perplexed (Nation Books). His website is wordsontheweb.com.