So the question, “How can an animal production technology, which is proven to be cruel to the animals it creates, be kosher?” is actually not difficult to answer for a halachist. And that is all the OU is purporting to be here- an enforcer of the technical standards of kashrut. Thus, to engage the issue on those terms is allow the actual issue - whether this behavior is ethical - to be sidestepped under the guise of a discussion of kashrut. Using the term “kosher” here may seem like a stronger argument, but it’s actually weaker. “Kosher” carries emotional value and seemingly relevant moral authority and so might appear to be the correct heading for the debate. It is not. Tsar ba’alei chayim (not causing pain to animals) and kashrut are not synonyms. The sooner we are all able to make that differentiation, the sooner we will be able to debate both of those issues from a place of strength.

One thing I’ve been trying to figure out is why companies want to clone animals for meat. Whatever the benefit of a clone, the process is still way too complex to make it anywhere near cost effective.
This response seems to imply one goal would be to clone a small population of studs or mothers that can then make a larger population of offspring with better control of specific traits. Unless they only use first generation offspring, I’d have trouble imagining that problems wouldn’t either increase to a clearly visible level or decrease to insignificance in a couple of generations. As for keeping all animals on large doses of antibiotics, that needs to stop whether or not the animals are clones.

The other purpose of cloning would be the theoretical medicinal uses where genetic engineering is used to cause animals to produce a specific chemical for medicines. In this case, small health changes are less significant and the extracted chemical would be regulated like any other medicine.

Am I missing any other reason why a for-profit industry might want to clone?

I am one of the authors of the paper—”Not Ready for Prime Time”, and I am not a lawyer, but rather a scientist that went on to get training in ethics.

Several of the questions you pose are actually not scientific in nature, but go to questions of policy in agencies. You say that the FDA is not concerned with environmentalism or even animal safety. That may be the factual case, but that is not what policy and law require. All Federal agencies are subject to the National Environmental Policy Act, but the FDA continues to claim that the changes in cloning are just animal breeding that it does not regulate. Even the FDA admits that it has concerns about animal welfare. It will not approve of drug trials that don’t meet animal welfare standards. In Sept of 2002, John Matheson on of the FDA authors of the draft risk assessment said that the animal safety issues of cloning are definitely covered under the New Animal Drug Act. He said that they will apply it by emphasizing “things that we can measure, related primarily to animal health.” (Pew meeting in Dallas)
I am of the opinion that the FDA decided not to use the New Animal Drug Act standards for the approval of animal cloning in large part because they require a higher standard of animal welfare and a higher standard of research design than their final risk assessment employed.
The issue of food safety related to clones is in my opinion NOT decided by the risk assessment that the FDA produced. The FDA relied primarily on compositional analysis of a small number of clones and did not even have clear criteria for which studies it would include. The FDA moreover misrepresented the findings of several studies in order to support their conclusions. This is not “innuendo” on my part, but is borne out by comments that the authors of some key papers used by the FDA in its analysis.
One of the key issues is whether the offspring of clones are safe to eat and the FDA looked at even less data from offspring than it did from clones themselves. In short, a key question is whether defects in the cloning process are bred into offspring. The FDA paper argues that offspring are reprogrammed and that defects do not pass on to them. The papers they use suggest otherwise, and when I asked the FDA lead author, Dr. Rudenko, about this inconsistency, she said that changes like shortened telomeres are passed down in some of the animals, but that if this causes a problem in the animals this problem is likely to cause problems in older animals and not the ones that would be slaughtered. She then said that in anycase, the slaughterhouses would cull these animals before slaughter. I guess she has a greater level of confidence in the effectiveness of US slaughter houses than do I. If cloned animals continue to be sicker than their conventional offspring, the animal welfare issues will contribute to greater use of antibiotics and hormones to keep the animals on their feet long enough to be slaughtered.

These next comments draw from my comments yesterday to the USDA on Advisory Committee on Biotechnology and 21st Century Agriculture. (Note: the full comments will soon be posted on our website with my name on them. We normally publish our names on testimony, but not on reports.)

Conclusions of epigenetic and genetic aspects of SCNT

The Executive Summary in the final risk assessment notes, “If clones were to pose food consumption risks, the only mechanism by which those risks could arise would be from inappropriate epigenetic reprogramming.” Then it goes on to say, “anomalies present in clones do not appear to be transmitted to the next generation.”

But a 2003 peer-reviewed study cited by the FDA found that progeny of mammal clones can inherit certain epigenetic changes and a 2005 study also cited found that epigenetic changes in telomeres passed down to offspring, but their findings are dismissed. Dr. Betts, the lead author of the 2005 study, recently criticized the FDA use of his study, asked if he agrees with the FDA’s assertion that genetic errors are probably reset in the offspring of clones, Betts said: “Based on my study, I wouldn’t support that statement. My study would say the opposite, that they are not reset.” The US National Academy of Sciences in 2004 stated, “Little evidence is available in the scientific literature to assess whether the progeny of cloned animals are at increased risk for inherited or developmental defects.” The inadequate understanding of the epigenetic effects of cloning should not be used as an argument for safety of the cloning process, but rather argues for more studies involving more animals.

No standards for “normal” in meat and milk

One of the biggest problems in the FDA assessment of the safety of food from cloned animals is that the FDA standards for meat and milk were not designed for this purpose. Their standards were developed on the assumption that milk and meat should not be adulterated by external substances or contaminated with pathogens or pus from the bodies responses to pathogens. They have no standards for protein and mineral levels outside this up-to-now understandable focus on alteration and pathogens that they can apply to the products of cloned animals.

The FDA Final Risk Assessment notes that none of the studies mentioned are outside the normal variability in the composition of meat (cattle and swine) and milk (cattle) between clones or clone progeny and their comparators. To the best of our knowledge, there exists no agreed upon standard for what constitutes the protein, lipid, and hormone mix of meat or milk, unlike the standards that are being developed for major crops. This should be noted and the source of the implied standards for “normal variability” should be identified in the document. In short, the studies do not make clear how they determined “normal” for the choice of comparators. The small sample sizes for both the clones/clone progeny and the comparators, make it difficult to draw meaningful conclusions.

The FDA is not assessing other approaches to cloning such as embryonic cell nuclear transfer (ECNT), but relies on a feeding study that uses ECNT clones as a baseline comparator. A baseline comparator for the outcomes of SCNT cloning as the information related to the animal health, food safety and composition of animals resulting from embryo splitting and blastomere transfer is not readily available in the published peer-reviewed literature and provide limited information as evidence of a history of safe use and as a baseline comparator. Unfortunately, this small study with questionable comparators is the most robust study the FDA uses to assess the safety of cloned meat and milk. It is the only study that uses standard toxicology methods to assess the potential danger of consuming meat and milk from cloned animals.
Many of the studies cited in the Risk Assessment for the proposition that milk from cattle clones does not pose a food safety concern, reported significant differences between the milk of cloned and non-cloned cattle. The FDA did not do its own studies, but relied on 10 small studies. Half of the studies of cow meat found differences in the composition of food from clones and ordinary animals; both the studies of pork meat relied on the Viagen data and they both found significant differences in meat from clones and ordinary pork.
The Walsh (2003) study appears to be the largest and most comprehensive study on the composition of milk from cloned cattle. Testing of 15 dairy cow clones from 5 donor cell lines of 3 breeds of cattle revealed: 1) significant differences in the amount of palmitic acid and linolenic acid; 2) different fatty acid profiles for the cloned milk; and 3) the greatest variability observed in the mineral content of the cloned milk–differing significantly in potassium, zinc, strontium, and phosphorous levels. Though the overall conclusion of the study was that there were “no obvious differences between the milk from clones and non-clones”, the researchers merely speculated that the differences could be attributed to diet, lactation cycle differences and seasonality. No additional studies showing whether differences in milk and meat composition are likely attributable to these dietary and other differences or to the cloned status of the animals were cited by the FDA. The largest published study cited uses data from 37 clones in three other cloning studies to compare the animals against comparators and found that similar changes were found in all three groups of clones, but considered the data within “normal range.” The co-author of that paper, Dr. Chavette-Palmer says, “. Our study is one of the biggest published, but it’s still limited. …There is not enough data to indicate there will be no problem. We feel there is a rush to accept those clones.”
The significant differences in cloned milk composition revealed by these studies raise serious concerns about whether milk from clones is safe for human consumption. Without more data, and standards for which “normal variations” in protein and fatty acid compositions of meat and milk are safe, any conclusions regarding the safety of food products derived from clones and their progeny are premature.

In short, we want the FDA to do a better job of assessing the Science of cloning. The FDA invented a new weaker standard of risk assessment for a product that likely would not have made it through the new animal drug safety review. When FDA approves a drug and makes a wrong call, it is at least labeled so it can be recalled. FDA opposes labeling of products from clones, so if it has made a wrong call on cloning, there is no recall mechanism.

Jaydee Hanson
Policy Analyst, Center for Food Safety

It’s also not that I don’t respect your perspective as a lawyer, but that you are responding as a lawyer to scientific questions.

First off, I’m interested to know who you are and what is motivating your strong position on cloning technology. You clearly have some technical understanding of the issues here. Please let Jcarrot readers know who you are and where you are coming from.

Yes, I am one of four active attorney with the Center for Food Safetey. In addition to our attorneys, we have organizers and a Science Policy Analyst. We also collaborate on issues sich as cloning with our sister organization, the International Center for Technology Assessment (www.icta.org).

Regarding food safety and FDA’s decision to approve cloned animals for meat and milk production, “Not Ready for Prime Time” offers a real look at the science behind the food safety problems, animal health issues and the general failures of cloning to provide safe, stable food.

Because you do not seem to respect my perspective as a lawyer, I have requested that Jaydee Hanson, Policy Analyst from ICTA, who helped to create the report “Not Ready for Prime Time” - to respond to you. He will respond soon.

zelig

Also, I can’t actually find any links to that document from the CFS main page. The actual report also doesn’t have authors listed on it (just cover art and report design). Generally, even position papers from an organization mention who actually contributed to the text.

Now to critiquing the text of the CFS position paper. As far as I know, the FDA is not concerned with environmentalism or even animal safety as long at it doesn’t directly affect the danger of the consumed food. Other organizations like the USDA care about this stuff. From what I understand of this issue, the FDA was trying to answer one main question. If we clone and animal for food, is that food safe to eat? The FDA research into this topic decided the answer was “yes.” Except for inuendo and scare-mongering, I didn’t see anything in the CFS report that contradicted this decision.

Yes, due to telomere lengths and other changes in cloned animals, a clone is genetically, but not biologically identical. Yes the success rate of cloned birth is lower than the typical artificial insemination on farms. In fact most of the reasons you listed and that are listed in the report explain why the costs outweigh the benefits of cloning for mass consumption. But again that isn’t what the FDA was studying.

Back to the kashrut question. What in that report has anything to do with kashrut. As we find out more and more often, kashrut has nothing to do with humane farming. It has to do with halacha. There is some overlap, but kashrut is not synonymous with ethics. Ideas like the hecture tzedik and some of the more well thought out writers on this blog realize this.

To produce clones, scientists grow copies of cells from the original animal in a lab dish, and then extract genetic material. The DNA from the animal to be cloned is inserted into an egg whose nucleus has been removed, and the resulting embryo is implanted in an animal that will serve as the clone’s surrogate mother.

This process itself may not be cruel, but the result is…

Scientists that have been on the front lines of cloning since Doll show many Problems associated with cloning including: 1) Pre-Natal Failures: Only a small percentage of cloned pregnancies result in live births. A 2007 study found that animal cloning failure rates remain as high as 90 percent; 2) Surrogate (Host) Suffering: “Host mothers” face grave suffering, much of which is caused by inordinately high rates of spontaneous abortions. Cloning often leads to a condition known as “large-offspring syndrome,” whereby cloned offspring grow abnormally large, causing early-term and stressful caesarian deliveries.4 In one cattle cloning project, 3 out of 12 surrogate mothers died during pregnancy; 3) Post-Natal Animal Health: Most cloned animals born on a farm, outside a veterinary hospital, have little chance of surviving. Those animals that manage to survive until birth are likely to suffer a wide range of health defects and deformities including: enlarged tongues; squashed faces; intestinal blockages; immune deficiencies; diabetes; high rates of heart and lung damage; kidney failure; and brain abnormalities.

This isn’t fear mongering. This is simple observation of basic facts and opining that such technology is not something I would be willing to eat, or consider suitable from a religious/spiritual perspective.

For more information: Check out our highly documented review of the scientific literature contained our the Center For Food Safety Report: “Not Ready For Prime Time” - If you still think that clones are the same as natural animals, I’ll send you to some primary sources - which you’ll find referred to in this report:

http://www.centerforfoodsafety.....20time.pdf

From the kashrut perspective, I’ll flip your questions. If cloning is done from a live animal and the animal is raised on a free range farm with an organic grass fed diet, would you see any kashrut problems with cloning?

From your other questions, from a kashrut perspective why would cloning be different from other forms of articial insemination that are regularly practiced?

Fair enough! I have not read the OU’s statement on cloning cows. I’d be curious to do so. From the article, it’s hard to say whether this is one rabbi talking off the cuff, or if his quote is a position that has been throughly vetted.

In searching for hints either way, I found this quote from a 2004 OU statement on cloning for humans. A slightly different context, I know, but the principle should be the same, right?

However, cloning research must not be pursued indiscriminately. We must be careful to distinguish between cloning for therapeutic purposes – which ought to be pursued, and cloning for reproductive purposes – which we oppose. (www.ou.org/public/Publib/cloninglet.htm)

Have they changed their mind? Or are they bowing to market “realities” in a context where they have skin in the game? It appears to me that perhaps they should at least back up this quote in the paper (giving them the benefit of the doubt that they were under-quoted) with a statement on the website. I hold no one so sacrosanct that I don’t expect complete transparency from them, especially on sensitive issues.

I admit my previous comment was a bit flippant, and perhaps a tad cynical. Vidui. I suppose I am approaching the issue from an ethical perspective, not simply a ritual one. I accept the charge of poskin in this instance, but not without a caveat. While I don’t know thing one about OU’s true intentions (but don’t intend slander), or much about the finer points of kashrut halacha, for that matter, I do know a few things about the issues regarding GMO and cloning in our food supply. I know enough to say that our best science, as it stands today, does not know enough about the consequences of these technologies to say with a high degree of certainty that they are as safe as the real thing. I’m not sure this falls into the category of “appropriate technology” yet.

But say the science is sound, for a moment. What of the ethics of cloning Hashem’s creation? Some in the ethical kashrut community say that eating any animal goes too far (”of every tree in the garden,” “your food shall be the grasses in the field”), with more justification than I can dig up now. This is what I mean by deep thought.

Look, clearly, I’ll be out-rabbi’ed by you every day of the week, but from a layperson’s perspective, and one who feels it’s very important for Judaism to act as a moral compass (not merely a ritual one) in our broader society, I think our institutions—especially those as august and trusted as the OU and its hekscher are—need to start paying attention to questions of ethics and morality that are actually relevant to Jews and those who look to Jews for shaila, as was the SF Chronicle, however casually.

I refuse to let this one sit without discussion on the grounds that I’m poskin.

Zelig’s questions are of deep concern to me, so I’ll shut up now and let someone offer an informed answer to them!

With love and respect,
David