Waiter, there's a clone in my soup! (Sujatha)

Coming to a restaurant near you sooner than you might think, if it already hasn't made its way to your dinner table as the offspring of clones.

From the 01/15/08 Yahoo news report on the FDA granting approval to cloned meat entering the human food chain:

The US 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 actual mechanics of when and where cloned livestock could enter the food chain is still hazy and remains controversial. More from the report:

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.

What does make fascinating reading, however, are the reams of reports released by the FDA on its website regarding the inputs into its decision that meat and milk from cloned livestock (bovines, swine and goats) are unlikely to pose any risks to humans.  For instance, in the report detailing the tests performed on cloned swines, we get a detailed insight into the workings of the research center, a fish eye view of the constant daily tests of clone #18, #23 and their health problems ('scours', 'poor doers', low weight gain...) and the final slaughter and analysis of the components of the muscle meat:

The lack of biologically relevant differences in the food composition values between muscle of swine clones and comparators supports the conclusion that there is no additional food consumption risk from the consumption of muscle from swine clones compared to their conventional counterparts.

The main ethical issue that emerges is the patent ill-health of the cloned animals, rendering them more likely to be euthanized because of health problems (animals culled like that in commercial operations are not allowed to be used in the food supply, though the carcasses may be sent to rendering plants where it might show up in other products, conceivably- pet food comes to mind.). There are greater health risks documented for the surrogate animals used to carry the clones to term. The costs of producing a clone as opposed to the regularly used artificial insemination to breed livestock are quite prohibitive, as well.

The whole set of reports is quite informative. It includes Japanese rat studies (from 2002) showing that rats ingesting freeze-dried beef and milk from clones over a 28 day period didn't show any deleterious changes in their blood or organs.(My question about the design of that study- why wasn't it allowed to continue for the full lifespan of lab rats, typically 170-190 days and then evaluating the rats after their natural deaths?)  According to the executive summary,no such ingestion data seems to exist for swine meat and goat meat. Swine meat was not tested by ingestion by lab animals, only for composition, while no data whatsoever was available for composition or ingestion of cloned goat meat.

Couldn't the FDA have requested data on that before making decisions on declaring cloned meat for all categories most likely safe for the food supply?  They weren't willing to stick their neck out and declare cloned sheep meat safe, perhaps because of the high level of adverse publicity when Dolly the cloned sheep died prematurely at 1/2 the regular life-span. Is there a possibility that clones, which are generally more liable to have developmental problems would be more susceptible to say, mad-cow disease, or foot-and-mouth disease that resulted in major culling of herds globally?

They already waited for a few years before releasing this risk assessment, what's a few more while some more animal studies are conducted? Why this unseemly hurry to place a stamp of approval on letting cloned livestock enter the food chain? Or is it because it might have already entered the food chain, as this report would seem to indicate:

At least one Kansas cattle producer also disclosed yesterday that he has openly sold semen from prize-winning clones to many U.S. meat producers in the past few years, and that he is certain he is not alone.

"This is a fairy tale that this technology is not being used and is not already in the food chain," said Donald Coover, a Galesburg cattleman and veterinarian who has a specialty cattle semen business. "Anyone who tells you otherwise either doesn't know what they're talking about, or they're not being honest."

In effect, FDA is flinging open the stable doors after the horses have bolted. So much for regulatory control over what reaches the consumer's table.

Update: The USDA gets cold feet over the FDA's approval. (Washington Post, login required)

Food and Drug Administration officials today announced that food from cloned animals is safe to eat even as their counterparts in the U.S. Department of Agriculture asked producers to keep their cloned animals off the market indefinitely.

The request for an ongoing "voluntary moratorium," by Bruce I. Knight, the USDA's under secretary for marketing and regulatory programs, is aimed at facilitating "an acceptance process" that Knight said consumers in the United States and abroad will need to go through over the next few years, "given the emotional nature of this issue."

The two announcements reflected ongoing divisions on the issue among U.S. food-related agencies. Knight's request provided a somewhat awkward counterpoint to the message from Stephen F. Sundlof, director of FDA's Center for Food Safety and Applied Nutrition, who oversaw that agency's six-year review of the safety of milk and meat from clones and their offspring.

Comments

[Ruchira]

If it is all safe and healthy, why the reluctance on the part of the FDA to require marking all meat coming from cloned animals (or their progeny) to reflect that fact?

I don't know about the increased risk of mad cow disease (which has been traced to feeding animal offal to otherwise herbivorous animals) among cloned cattle but I bet there will be other defects which cause pain and suffering to the animals themselves and may well harm those who ingest their meat.

[Sujatha]

I suspect that progeny of clones have already made it into the system, without being marked as such, but that shouldn't dissuade the FDA from permitting proper labeling of such meat. Why not let the marketplace decide about the desirability of meat derived from clone progeny, just as happened with the FlavrSavr tomato, for example. Unintended consequences arose from what was thought to be a better premium variety of transgenic tomatoes:

"The failure of the Flavr Savr has been attributed to Calgene's inexperience in the business of growing and shipping tomatoes [1]. The variety of tomato Calgene started with was considered by farmers to be inferior, and insufficient resources were allocated to traditional plant breeding. As a result, Calgene's fields produced only 25-50% as many boxes per acre compared to most growers. Of these, only half as many as anticipated were large enough to be sold as premium-priced. Furthermore, much of the initial harvest was damaged during processing and shipping because ripe tomatoes are unavoidably more delicate than unripened ones. Equipment designed for handling peaches was purchased, and specialized shipping crates were developed, both at great expense. These costs along with competition from a new conventionally bred Long Shelf Life (LSL) variety prevented the Flavr Savr from becoming profitable, and Calgene was eventually bought by Monsanto which was primarily interested in Calgene's ventures into cotton and oilseed."

Incidentally, one area the FDA doesn't seem to take into account is that of epigenetic changes. (Reader Will had mentioned them briefly in a comment on the genetics post.) Because of these genetic variations, due to environmental and other unknown factors in utero, even a clone growing in a surrogate womb is not always a perfect carbon copy, accounting for around only 3 out of around 28 such clone implanting turning out viable animals, while the remaining either miscarry or develop with gross abnormalities. So, the FDA is essentially going by the 'appearance of good health' in a clone to say that its progeny are alright for introduction into the food chain, but with no real insight into epigenetic changes which might prove problematic in the long run.

I suppose we won't see 'armies of clones' soon, but we could see 'armies of clone's children', if this catches on with the breeders of livestock. If there are any issues with increased susceptibility to various diseases, whether it be mad cow from unintended exposure to rendered proteins in feed, or foot-and-mouth or other diseases, the breeder will see his stock of progeny from clones of prized animals wiped out or at least seriously decimated.

[Ruchira]

This one they are saying is only for the stem cells.