As anticipated, a draft ruling from the Food and Drug Administration concludes the meat and dairy products from cloned animals are safe for human consumption. As the Associated Press reports
The government believes "meat and milk from cattle, swine and goat clones is as safe to eat as the food we eat every day," said Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine. Meat and milk from the offspring of clones is also safe, the agency concluded.Given the FDA's conclusion, there is no legal basis to require the labeling of products from cloned animals, but this does not mean we won't soon see "clone-free" labels.
If consumers truly care about whether the milk or meat they consume was produced, producers will have an incentive to respond by offering "clone-free" meat and dairy products, and labeling them accordingly. At least one producer, Ben & Jerry's, plans to do just that. The Vermont ice-cream makers already advertise that they do not use milk from cows treated with recombinant bovine growth hormone (rBGH). Even though the use of rBGH has no effect on the milk cows produce, this may influence some consumers (though I suspect the high-milk-fat content is the real basis for Ben & Jerry's' popularity).
The legal standard the FDA uses in determining whether it has the authority to mandate labels is the right one, in my view. If the use of a biotech production method, whether the application of an engineered hormone or the cloning of animal stock, does not result in a difference in the product itself, there is no reasonable basis for mandating that the product be labeled, irrespective of consumer preferences. The range of production methods that are of potential interest to consumers is limitless. In these contexts, what information consumers want should be revealed through the interplay of consumer and producer behavior in the marketplace. In the end, perhaps most clone-derived products will be labeled. If so, it should be due to consumer demand, not government mandate.
Related Posts (on one page):
- Cloned Bull:
- Clone Meat and Milk "OK"; No Need to Label:
- "Clone on the Range":
Well, there might not be any basis in the Food, Drug and Cosmetic Act. But there may be a basis in other laws, including state laws, just as there are or could be (state and federal) laws requiring source-of-origin, union-made, and other labels.
If a legislature determines that a lot of consumers are reasonably interested in the information for, e.g., ethical or aesthetic reasons, or because there's still some uncertainty about health effects (even if not sufficient to trigger FDA regulation), why couldn't (or shouldn't) the legislature mandate labeling? Or, more to the point, why is safety and efficacy labeling (under the FDCA) more legitimate or desirable (or permissible?) than these other sorts of requirements? In each case, "consumer preferences" might lead to effective and accurate self-labeling. But in each case, the legislature might conclude that a legal mandate will lead to better, more comprehensive, and more accurate information overall.
Do we need to have "the talk" with cows and sheep now?
The attraction to such issues over a broader ethical or survivalist approach is the broad deference that health &safety considerations have before the courts.
A labeling law for itself, detached from health&safety could lead to heightened scrutiny.
The serious issue with cloned animals is really an insurance question. Genetic similiarity provides another variable of correlation under which entire herds could be lost. Moreover the risk is long-run. You can bet on genetic engineering working &win for a long while, driving your non-cloned counterparts out of business with your cost effectiveness. Given enough time though we may faced an unexpectedly large loss.
You raise two questions: Could the government require labels indicating how aproduct was produced, and (if it has the power) should the government do so. With some qualifications, I think the answer to both questions is "no." Let me give a relatively short answer here, but I will be posting longer explanations in coming weeks/months as I am working on a full-length article explaining the basis for my conclusion that consumer interest, by itself, is not a sufficent basis to compel commercial speech, such as product labeling.
Taking the two questions in reverse order. I don't think the government should require the adoption of a label that does not disclose meaningful information about a given product. By "meaningful" I mean information that serves to protect the consumer in some way (e.g. food content information that protects consumers from potential allergens or health risks). I believe it is unnecessary for the government to mandate such disclosure because, where such information is truly valuable to consumers, competing producers have very incentive to discover this fact, and act accordingly. (See, e.g., Kosher labeling, which is purely voluntary and completely effective). Indeed, we should expect competing producers to discover such consumer demand more rapidly than government officials because of the incentives they face. Moreover, where competing producers refuse to disclose positive information on their own, and/or support the adoption of labels by government regulators, there are reasons to suspect that labels would "tilt" not "equalize" the playing field.
These policy arguments, if extended, also suggest why I believe mandatory labels for non-product-related characteristics should raise constitutional concerns. When the government mandates a label disclosing a production method -- whether a product was union made, birthed by a clone, hand-crafted by Tibetan monks, or blessed by the flying spaghetti monster -- it implies that this information should be relevant to the consumer -- as this information was selected of the truly infinite production characteristics that could have been the subject of mandatory labels. Such information is relevant to consumers not because they are threatened in some way, but because of their aesthetic, normative, and perhaps religious preferences. When the government mandates such labels, it is effectively choosing sides on these values questions, and potentially requiring product manufacturers to stigmatize their own products by attaching a label that implies there is something wrong with their product. (After all, if the mandated label discloses information that most consumers see as a plus, then we should expect producers to disclose such information voluntarily; mandatory labels are only at issue where producers would refuse to label on their own.) The government is, in effect, forcing producers to convey a value-laden message with their scarce resources with which they disagree (such as that there is something wrong with non-union products, cloned meat, etc.).
I would also suggest that if "consumer preference," by itself, is enough to justify a mandatory label, and is permissible compelled-commercial speech, then any mandatory label adopted by the government, by definition, satisfie the First Amendment. Why? Because we can assume that any label that is adopted by a legislature or agency is adopted in response to some amount of consumer demand. Whether or not one accepts my test, I would suggest that this alternative is untenable if there is any meaningful protection for compelled commercial speech. What, then, is a meaningful alternative? Do you (Marty) have an alternative? Or is it anything goes when it comes to labels? And, if so, is there any constitutional protection against compelled commerical speech?
JHA
Cloned animals will be much more expensive because of the techniques involved. And, while the research is interesting, one female clone currently does not (and I can't see when that threshold could ver be crossed) justify the cost of producing herself again. A female animal can have only so many offspring. And males can produce many offspring without cloning - witness some of the AI studs that have tens of thousands of milking daughters through the wonder of frozen semen.
So the issue isn't milk or meat.
Folks who fear human cloning don't like it because the knowledge gained will be transferrable to human cloning.
Europeans are cynically making a big stink (just like they did with GMO crops) in the hopes of scaring the world market away from American products.
However, if the push for labeling is consumer driven, and the consumers want, not cloned, but non-cloned foods, then it is the NON-CLONED FOODS THAT WILL BE SO LABELED. That is not to say that all non-cloned foods will be labeled as such, but that those vendors who feel labeling their foods as non-cloned will give them a competitive advantage will so label them, voluntarily. It is not clear what competitive edge labeling one's product 'cloned' would provide, so absent a regulatory mandate, I wouldn't expect to see that.
I predict a state legislature will attempt to make clone/non-clone labeling mandatory, and the livestock industry will then argue such attempts are pre-empted by federal legislation.
I seem to recall that several years ago, a meat producer was preempted by the FDA from labeling its product in some way that suggested that it might be safer as regards BSE (mad cow) infection. There was some controversy because the label -- the precise content of which I can't remember at the moment -- was accurate on its face and there was at least a debate as to whether it might be useful to consumers to have that information. Query whether the FDA might not prohibit "clone-free" labels on the ground that the labels purportedly suggest a health risk from clone products.
If you're looking for takers on that bet you are in for a disappointment.
First of all, FDA is a science-based agency and could careless about public opinion (nor should it). It is not the government's job to engage in a PR campaign or to educate the public (OK, some may argue the whole "winning hearts and mind" deal is such but I digress). I think the public will be less influenced by the ick factor once industry takes on the challenge of educating the public.
I often find that people who are not genuinely familiar w/the science tend to fall back on the "fear of the unknown" phenomena. R&D on cloned and GE animals has been taking place for decades. There is an abundance of research from industry and universities who engage in animal husbandry. To think the FDA is making such a regulatory decision not based on sound science, is absurd. (And no, I don't want to receive a bunch of rebuttals re: Plan B.) So, if you are waiting to grow a third foot or waiting for these clones to have a shorter life than the originals, don't hold your breath. FDA's regs/standards required to show a product as safe and effective are very high. Remember, you can't prove a negative.
As for the commenter stating you won't see these cloned animals on the market, I disagree. You won't in the near future but you will see their products (both food - wh/includes milk - and drug related) on the market and soon thereafter the cloned animals themselves. Yes, it is extremely expensive to produce such clones (if you are running low on cash, go steal yourself an $800K cow), but to keep this short I will say there are numerous reasons/ways the science and the market will accomplish the offsprings' presence in the market.
I am very familiar w/the legal issues here and I believe Adler's proposed legal arguments are the direction the courts will head in if they follow the rule of law. For all you defense lawyers out there, you may want to get a head start b/c there are organizations chomping at the bit to file suit. Once again, not to get into a drawn out discussion, but federal preemption will be a big issue here (as it should.) Ha! I can't even imagine the smorgasborg of state legislation that would arise resulting in 50 different safety and effectiveness standards.
I mean, yes, of course it is possible to genetically combine DNA in order to make a foodstuff that is poisonous or dangerous. But what does that have to do with anything?? It is possible to make an automobile that is dangerous, but that doesn't mean that all automobiles are dangerous, or that a safe auto can't be made. Recombinant food sources are among the most studied items ever to appear on the market. It makes zero sense to insist that they are somehow dangerous without ever explaining how, or ever giving one credible example of this ever happening.
Science is not magic. Chemistry is not some dimly understood field. People who prey on the ignorant fears of others should be publically called upon to put up or shut up. Unfortunately, I can guarantee you that an alarmist, fact-free, "cloned food!!!" issue of Time is already being planned.
Cloned livestock or cloned agricultural products should be met with applause. Thank goodness! Millions of people-- heck, hundreds of millions of people-- will not starve to death because of this technology. When does that get mixed into the equation?
There are few incentives to prevent this from happening. Quite the reverse - these animals are being cloned to preserve an especially worthy genetic makeup that farmers and ranchers want to promulgate. Within a remarkably short period of time, there would be such a large distribution of "clone-derived" cattle that it would be very difficult to prove that a herd was "clone free".
Only incredibly strict breeding techniques (essentially keeping a full record of the ancestry of every animal ever introduced into the herd since the advent of cloning) could prevent "contaminating" the herd with the cloned germline. This is a much more difficult task than policing the use of rBGH. The record keeping alone becomes staggering within just a dozen years, and assumes that the record entry is perfect.
There are farmers out there that do keep good records of breeding history (the Neiman Ranch collective, for one, requires it) - but this requires not "good" records, but "perfect" records. For (human) generations. This will not happen - eventually the entire US animal herd of specific cattle breeds will have "cloned" DNA.
Why this matters is anyone's guess. Genetic cloning happens accidentally (twinning) all the time and no one is freaked out about it. Cloning without germline engineering (introducing new DNA) seems unlikely to be much different. Either the cloned animal survives and is a healthy member of the bos genus (which has been manipulated via animal husbandry practices like no other), or it and its offspring die early and the line dies out. It's not like putting peanut genes into the animal - bos goes in and bos comes out.
Dairy cattle registries by way of strict identification policies, DNA typing for selected animals, etc can allow producers to determine if they have cloned animals in their herd or if an animal's ancestors derive from a clone. For example, Holstein USA requires clones to have a specific identifier as part of their registration number.
What this will come down to is producer choice - do they want cloned animals in their herd? Many will, some won't. Economics will be undoubtedly be the primary factor for many producers.
As noted on the starter thread, cloning is a good management tool, which can provide economic benefit, but there are downsides.
Note for another poster on the thread - the case concerning a company wanting to label its' beef BSE free is Creekstone Farms Premium Beef, LLC V. USDA 1:06-cv-00544-JR
Why do the clones seem to die sooner, or is this just a myth?
Those points are irrelevant when we are talking about food animals. Their lives are already "shortened." They don't die of old age; we kill them and eat them. In that context, what matters is their fitness to be eaten. In that sense, there is absolutely nothing wrong with cloned animals. We don't absorb their whole genome, just the atomized fragments that our stomachs make of it. We don't absorb their intact proteins, just the molecules that make them up. From that perspective, a little more telemere on the end of chromosome 21 doesn't matter at all.
The only possible concern would be one of "natural selection." That, by cloning, we would create a highly successful breed of cattle that would force out, by natural selection, all other breeds of cattle. This might create a very narrow genetic strain upon which all our food herds would be based. Thus, a single disease-- like mad cow-- could come through and wipe them all out. No genetic diversity to protect them. (But I suspect that scientists are way ahead of me on this. They probably have zillions of cell types stored away for future use.)
However, that said, I also think it important that a previously popularly-accepted practice such as feeding herbivores (cows) as carnivores (ground up bone-meal, mammal by-products, not sure what the exact term is) is linked to mad-cow disease.
Also, I believe there are more than two instances of drugs approved by the FDA that have been subsequently pulled from the market (drugs that passed clinical trials, but, once used by the general populace proved...less than beneficial in many instances).
So I don't understand the problem with labeling certain products accurately -- i.e., cloned. I, personally, don't want my doctor to prescribe anything that hasn't been on the market for 5-7 years.
I don't want to be a human guinea pig. Why isn't that my right? I'm simply asking to be informed regarding the contents I ingest.
I think it would be absurd to have a labeling requirement for something that has no measurable difference and, potentially, feeds into uninformed consumer outrage.
It's not true, by the way, that rBGH has no measurable effects on milk. There are substantial endocrine changes that take place during lactation in cows treated with rBGH. Some of these changes are produced in the milk. Probably the most worrisome one is insulin-like growth factor-1, which has a demonstrated effect on laboratory rodents. There is no evidence, however, that the effects present a danger to the public. But labeling, in this case, is appropriate.
With a cloned animal, however, an artificial method of mating, so to speak, is introduced, one that is lateral instead of vertical, with much more heterogeneity than can be found in twinning, which represents an exact copy in all respects.
There is no change in the proportion of one gene vs. another, no change in hormones, no introduction of artificial anything, no treatment with artificial anything (well, culture medium excepted - methods do change, however), no recombinant genes, and no genes from other organisms.
The future may hold such possibilities, though. Cloned zygotes could be transformed with new genes before implantation. Then, labeling would make sense.
The labeling issue is especially tricky for cloning. We're a long way off from having every animal cloned. It is far from cost effective. But there might be an instance where a good foundation bull is cloned, which offspring would not be cloned but propagated by the usual artificial insemination. How should a vanishing genetic history of a slab of meat be labeled?
I can think of another reason for aging: there isn't enough information to unambiguously determine what the correct information should have been. If the error corrector finds an AC base pair, it knows that this is wrong--but should it correct it to AT or GC? There are some tremendously clever error detection and correction algorithms out there that do what seems like magic in how they use only a few bits to detect and correct binary errors in large data arrays (Golay coding, for example), but I rather doubt that DNA's error correction is that clever.
I think I've seen speculation that something about sexual reproduction may reset whatever it is that controls this aging failure.