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[SANET-MG] Is FDA Promoting or Regulating Cloned Meat and Milk?
Is FDA Promoting or Regulating Cloned Meat and Milk?
Dr. Mae-Wan Ho and Prof. Joe Cummins find cloned meat and milk unethical
This article has been submitted to the FDA. Please circulate widely to
your elected representatives
Massive public opposition
US Food and Drug Administration (FDA) is about to approve cloned meat
and milk for the market. But a large coalition of civil society
organizations is opposing the decision on both safety and ethical
grounds . The coalition is led by the Center for Food Safety based in
Washington DC, and includes the Humane Society with nearly 10 million
members, and the Consumer Federation of America with membership of more
than 50 million.
A recent poll commissioned by the International Food Information Council
(a non-profit organization supported by the food, beverage and
agricultural industries) found nearly 60 percent of respondents would
not touch products from cloned animals with only 9 percent “very likely”
to buy them. This compares with 40 percent who would not buy genetically
modified animal products.
The European Commission’s directorate general for health and consumer
protection received a report from the project “Cloning in Public” in
December 2006, outlining the regulatory dilemma facing the European
Union. The leader of the project, Peter Sandøe, a professor of bioethics
at the Royal Veterinary and Agricultural University in Copenhagen, said
Europe can either stay put or start building cloning regulations
sensitive to ethical concerns now, depending on whether cloning will
really take off. If agricultural animal cloning turns out to be mostly
hype, as many in Europe suspect, Europe’s current legislations will
mostly suffice. If not, the EU would be unable to legally block imports
of animal clones, despite opposition from consumer groups. Building new
cloning legislation is an agonizing long draw-out process, and
ethics-based regulation would be hard to enforce, and all that could
turn out to be a huge waste of time and effort if animal cloning will
not take off after all.
Not surprisingly, the European Commission has decided to stay put.
Philip Tod, spokesperson for Markos Kyprianou, EU commissioner for
health and consumer protection said EU legislation in place for animal
breeding, novel foods and animal welfare is considered sufficient to
cover any cloning-related issues that are likely to arise. The
Commission is continually monitoring the developments in cloning and the
international situation, and will not hesitate to take the necessary
steps “if there is deemed to be a need for further scientific assessment
or risk management, or a review of the legislation to reflect new
Daughter of cloned cow born in UK
But events may have overtaken this decision. In January 2007, UK
newspaper Daily Mail reported that a daughter of a cow cloned in the US
was born on a farm in Shropshire in Britain, the product of frozen
embryos imported from the US and implanted into a surrogate mother .
This has triggered EU watchdogs to investigate the safety of food from
cloned animals and their offspring. Conservative MEP and agriculture
spokesperson in the European Parliament Neil Parish said, “We have no
shortage of high-producing excellent dairy cows in the UK, so why are we
risking a collapse in consumer confidence by importing the offspring of
It seems that although the existing food safety system in Britain and
Europe requires an assessment of meat and milk from cloned animals, a
loophole remains so that food derived from the offspring of clones does
not. Britain’s Food Standards Agency raised the issue at a meeting of
the EU’s Novel Foods Working Group.
Misleading ‘risk assessment’ by FDA and cloning companies
In preparation for FDA’s approval of cloned animal products, the agency
published a ‘commentary’ in the January 2007 issue of Nature
biotechnology  supported by a ‘perspective’ piece on risk assessment,
co-authored by scientists from at least two cloning companies . Both
papers put the same misleading positive gloss on cloned animals. The FDA
paper explains why cloned meat and milk are as safe as the conventional
products, because “there are no unique risks associated with animal
cloning,” while the risk assessment commentary cites the FDA paper in
agreement. Neither paper considers ethics or animal welfare.
Both papers present somatic cell nuclear transfer cloning (SCNT)
reassuringly as the latest development in a “continuum” of artificial
insemination, multiple ovulation/embryo transfer, in vitro
fertilization, embryo cryopreservation, cloning by embryo splitting, and
since the 1980s, by embryonic cell nuclear transfer (ECNT).
First of all, it is highly misleading to pretend that clones obtained by
nuclear transfer are the same as clones obtained by embryo splitting.
The latter is typically done at the 2-4 cell stage, and is not so
different from the twins or multiplets that happen naturally from time
Nuclear transfer cloning involves introducing the nuclei of embryonic
cells (in ECNT) or adult somatic cells (in SCNT) into unfertilised eggs
that has had the egg nucleus removed. The reconstituted eggs are then
activated to develop, and the resultant embryos are implanted into
surrogate mothers hormonally synchronized to receive them. Nuclear
transfer cloning, especially SCNT results in extremely high failure
rates from deaths and gross abnormalities, so much so that scientists
speak of a “cloning syndrome” that arises from errors in epigenetic
programming of the cell nucleus [5, 6]. The individual symptom may not
be unique, but the combination and the high incidences of the symptoms
certainly constitute a unique syndrome. It inflicts massive deaths,
suffering and distress, not only to the cloned foetuses and the calves
throughout gestation, at and after birth, but also to the surrogate
mothers . Surrogate mothers frequently die from difficult delivery
unless medical intervention is given, and their health is seriously
compromised by gross malformations of the foetuses.
There is also a big difference between ECNT in the 1980s and 1990s and
SCNT, which began with Dolly the sheep cloned in 1996, and has widely
supplanted ECNT since. ECNT before 1996 involved transferring the nuclei
of embryos at a few cells stage (8-32 cells), and there is a limit to
the number that can be cloned from a single individual embryo. In SCNT,
there is no limit to the numbers of reconstituted eggs that can be
created from a single individual adult, typically hundreds, just to get
a few successful clones. This inevitably results in a great reduction of
genetic diversity, which could make entire cloned herds susceptible to
the same diseases.
The whole point of cloning from an adult individual is that it has
proven ‘elite’ qualities, whereas the qualities of embryos are
completely unknown. So while the cloning umbrella covers both split
embryos and ECNT, that’s only regulatory camouflage intended to get SCNT
approved with the more conventional methods.
The FDA paper explains how the agency had requested industry in 2001 to
“voluntarily refrain from introducing food and feed from animal clones
and their progeny into commerce” while FDA undertook a risk assessment
of the safety of dairy and meat products derived from animals produced
by somatic cell nuclear transfer (SCNT).
But according to the risk assessment perspective from industry , the
public has already been consuming cloned meat and milk for years without
their knowledge. Perhaps that too, is meant to be reassuring.
“Approximately 1,200-1,500 cows and bull were produced by ECNT in North
American in the 1980s and 1990s.” Most of these cloned dairy and beef
cattle produced for research or commerce “were used for human food
consumption with no public knowledge or regulatory review.” They
estimate that “more than 300 000 kg meat and more than 2 million litres
of milk from cloned cattle have probably entered the food supply.”
They admit, however, that as these cloned animal products were mixed
with non-cloned animal products, “minor problems would have gone
undetected.” And as no data were collected on health-related issues
after consumption of such meat or milk products, “any statement on
effects is conjecture.” It should be emphasized that those cloned meat
and milk entering the food chain in the 1980s and 1990s were
predominantly from split embryos, and not from nuclear transfer cloning.
Admittedly, many deaths and gross abnormalities occur in animal cloning,
but the companies claim that those clones born alive and survive the
perinatal period are healthy . To support their case, they tabulate
nine studies, eight published elsewhere and one described in their
paper, showing that the milk and meat products from clones are
indistinguishable from controls, according to compositional studies on
proteins, fats, somatic cell count, amino acid composition, vitamins,
minerals etc, as recommended by the FDA .
Had the FDA recommended more discerning tests similar to those now
routinely used in the laboratory for DNA, RNA, protein and metabolic
profiling, large numbers of differences would have been detected, as
SCNT clones are notorious for epigenetic errors that result in major
changes in DNA markings, RNA and proteins expressed (see below), and it
would be surprising if these did not result in metabolic differences.
The most substantial of the eight published studies came from the other
regulatory agency, the USDA . It looked at milk in 608 cloned cattle
from conventional embryo splitting and 13 from ECNT, but none from SCNT.
The second study involved the carcass of 8 ECNT cattle only; the third
fed milk from an unknown number of SCNT cattle to rats; the fourth
examined blood chemistry of 18 SCNT cattle. So, only three studies
compared SCNT cattle carcass or milk with controls, and involved small
numbers, from one to a maximum of twelve (total 18), the ages of which
were not specified. One of the three studies also fed meat from one ECNT
and one SCNT cattle to mice and rats. The additional study presented in
the paper itself  included new data on blood chemistry and meat
composition of 11 SCNT cloned cattle compared with the same number of
controls, all older than 12 months.
By any standards, these data are grossly inadequate to establish the
safety of cloned meat and milk or any other cloned animal products. They
are also fundamentally flawed, as single parameters are compared, rather
than an entire pattern, so when differences did occur between the cloned
and non-cloned siblings, they were dismissed by the comment that the
values were within the normal range typical of the breed or species.
The authors try to gloss over the findings that apart from high
perinatal death rates (which would be even worse without medical
interventions), many die before 6 months of age, and those that survive
are fragile throughout life. Others have reported increased annual death
rates due to euthanasia of cloned cattle with musculoskeletal
abnormalities [5, 6]. In fact, the “cloning syndrome” is regarded as a
continuum occurring throughout the life of the clone, in that “lethality
or abnormal phenotypes that affect health or production may occur at any
phase of development possibly dependent upon the degree of dysregulation
of key genes. Even apparently normal clones may have abnormal regulation
of many genes that are too subtle to result in an obvious phenotype.”
The FDA, however, helpfully noted that those cloned cattle that had to
be put down are “otherwise healthy.”
The real story about cloning
At issue is SCNT, the procedure pioneered in creating Dolly the cloned
sheep in 1996  Death Sentence on Cloning, SiS 19). Cloning from the
genetic material of an adult animal means that all the genetic ‘elite’
qualities of the animal are proven, so the clones in theory will
reproduce those ‘elite’ qualities. More to the point, it allowed the
duplication of genetically modified (GM) animals without the normal
reproduction process, as GM animals tend to be either sterile or to lose
their transgenes or transgene expression in subsequent generations.
Dolly was a rehearsal for the cloning of an ‘elite’ herd of transgenic
animals producing valuable pharmaceuticals in their milk. That turned
out to be a pipedream. Cloning does not faithfully reproduce the
qualities of the adult, elite or otherwise.
The success rate of SCNT is extremely low, and remains so to this day,
between 0 and 5 percent across the species: sheep, cattle mouse, pig,
goat, rabbit, cat, not withstanding. Here is how one reviewer among
many, Jonathan Hill at the College of Veterinary Medicine, Cornell
University, New York described it when he was opposing human
reproductive cloning .
“In each of the species where somatic cell cloning has been successful,
it has also been very inefficient. Early first trimester pregnancy rates
are less than ½ that normally expected. Immediately following initial
positive diagnosis of pregnancy, extraordinarily high rates of embryonic
loss occur, where up to 80% of pregnancies miscarry by the second
semester. In late gestation, placental and fetal abnormalities occur at
a much higher than normal rate, and finally lowered viability at birth
So hundreds of reconstituted eggs have to be created to get dozens of
embryos good enough to be implanted into surrogate mothers just to end
up with a few clones born live.
Those few clones that survive after birth are by no means healthy:
“Postnatal viability is markedly lower for many cloned animals….Neonatal
viability has been shown to be compromised due to pulmonary immaturity.”
The remaining that seem apparently healthy are not without problems, for
“closer investigations have revealed that even some of these apparently
normal animals are subtly different from one another and from the
naturally produced population… What is of significant concern is that
placental development and the intrauterine environment for many clones
is suboptimal and this alone may impact on their health in later life.”
This was borne out by numerous laboratories involved in cloning. In one
experiment , 988 SCNT embryos were transferred into cows resulting in
133 calves delivered at term, but only 67 percent survived to weaning at
3 months of age, with an average annual death rate thereafter of more
than 8 percent. The offspring of SCNT clones fare better, though they
have not been subjected to more discerning tests either.
Dolly had to be put down prematurely at age six on account of severe
illnesses, and the company PPL therapeutics that helped to create Dolly
failed to find a backer for its GM alpha-1 anti-trypsin produced in
cloned transgenic sheep’s milk, and had to slaughter its flock of 3 000
transgenic sheep in 2003  (Animal Pharm Folds, SiS 19). Thus, SCNT
has proven neither technically successful nor economically viable.
Many, including Ian Wilmut, the creator of Dolly, saw that as the end of
SCNT cloning for producing animals, and have since concentrated efforts
into creating embryonic stem cells for tissue replacement. But that too
is misguided and ethically unjustified as many clinical successes in
tissue replacement have been documented using the patient’s own adult
stem cells while embryonic stem cells have yet to prove themselves in a
single clinical application so far  (No Case for Embryonic Stem
Cells Research, SiS 25).
The major problem with SCNT clones and with embryonic stem cells made by
SCNT cloning is the large numbers of genome-wide epigenetic errors in
gene expression associated with the nuclear transfer process, resulting
in the high failure rates of clones, and in the eyes of many scientists,
precludes the safe use of SCNT-derived embryonic stem cells in tissue
Microarray analysis of more than 10 000 gene in clones found that about
4 percent of the genes in the placenta are different from normal, with a
smaller number of genes also affected in the liver .
FDA paves the way for cloned transgenic animals
Indeed, the FDA does not see whole herd of cloned animals, and it seems
likely that the cloning process is intended at least in part to support
the creation of transgenic herds. FDA states : “Because of the cost
of clones and the high efficiency of sexual reproduction based on
selection of traits found in male cattle and swine, herds of dairy or
swine clones are not expected in the immediate future. Most of the food
produced from the cloning process will be meat and milk derived from the
sexually produced offspring of clones. The producing of milk by clones
may be considered as a by product of cloning cows (or other dairy
animals) for breeding purposes. Clones may also enter the food supply as
meat when they age beyond reproductive utility, when they are injured or
simply for financial reasons.”
FDA admits epigenetic errors as a source of hazards : “the low
success rates of SCNT, the perinatal difficulties observed in some
newborn clones and occasional examples of altered metabolic pathways in
very young animals” However, it reassures us that because grossly
affected animal would either die, fail to reproduce or fail a government
examination and meat inspection, their meat or milk would not enter the
human good supply, and the only remaining food consumption hazards
arising in clones would be those reprogramming errors that allow the
animals to develop with apparently normal functions, but with
subclinical physiological defects.
It is clear that FDA is intending by products from experimental animals
to enter the human food chain. There is no guarantee that sick or dead
clones, or failed laboratory experiments will not enter the food chain
as meat or sausage, for example. There have been many breaches of the
regulation regarding transgenic meat products, with transgenic pigs
ending up in sausages in 2003 , and it would surprising if these
breaches will not occur in the case of cloned meat products.
The sexually derived progeny of clones are thought to be exempt from
propagating epigenetic derived defect, but as mentioned earlier, these
have not been subjected to any scrutiny beyond the observation that they
FDA has enunciated two principles of risk assessment with regard to
cloned animal product : the Critical Biological Systems Approach,
based on the hypothesis that a healthy animal is likely to produce safe
food products, even if it needs some help during development; and the
Compositional Analysis Method, based on the hypothesis that food
products from healthy animals clones and their progeny that do not
differ materially from food from conventional animals are as safe to eat
as their conventional counterparts. Many will not find this reassuring.
The FDA has put such a positive spin on cloned animal products that it
is easy to mistake them for the promoters instead of regulators.
The public are right to oppose cloned animal products. Somatic cell
nuclear cloning is unacceptable on both ethical and safety grounds, and
it will pave the way to creating herds of transgenic animals that are
likely to be contaminated by potent vaccines, immune regulators and
growth hormones as well as nucleic acids, viruses and bacteria that can
create pathogens and trigger cancer  (GM Food Animals Coming, SiS 32).
1. “FDA’s cloning report bypasses ethics, exposes European dilemma”,
Peter Vermij, News, Nature Biotechnology 2007, 25, 7-8.
2. “EU puts its food police on the case of the cloned calf”, Daily Mail
15 January 2007,
3. Yang X, Tian XC, Kubota C, Page R, Xu J, Cibelli J and Seide Jr.G.
Risk assessment of meat and milk from cloned animals. Perspective,
Nature biotechnology 2007, 25, 77-83.
4. Rudenko L, Matheson JC and Sundlof SF. Animal cloning and the FDA-
the risk assessment paradigm under public scrutiny. Commentary, Nature
biotechnology 2007, 25, 39-43.
5. Wells DN, Forsyth JT, McMillan V and Obeck B. The health of somatic
cell cloned cattle and their offspring. Cloning Stem Cells 2004, 6, 101-10.
6. Wells DN. Animal cloning: problems and prospects. Rev Sci Tech 2005,
7. “Cloned animals a gallery of horrors”, i-sis news13/14, 12, 2002.
8. Norman HD and Walsh MK. Performance of dairy cattle clones and
evaluation of their milk composition. Cloning Stem Cells 2004, 6, 157–164
9. Ho MW and Cummins J. Death sentence on cloning. Science in Society
10. Hill JR. Abnormal in utero development of cloned animals:
implications for human cloning. Commentary. Differentiation 2002, 69,
174-8. Depart of Clinical Sciences College of Veterinary Medicine,
Cornell University, New York.
11. “Animal pharm folds”, Mae-Wan Ho, Science in Society 19, 43, 2003.
12. Ho MW. No case for embryonic stem cells cloning. Science in Society
25, 34-37, 2005.
13. Armstrong L, Lako M, Dean W and Stojkovic M. Epigenetic modification
is central to genome reprogramming in somatic cell nuclear transfer.
Stem Cells 2006, 24, 805-14.
14. Humphreys D, Eggan K, Akutsu H, Friedman A, Hochedliner D,
Yanagimachi R, Lander ES, Tolub TR and Janeisch R. Abnormal gene
expression in cloned mice derived from embryonic stem cell and cumulus
cell nuclei. PNAS 2002, 99 (20), 12889-94.
15. “Research piglets sold as food hard to find”, Elizabeth Weise, USA
Today, 2 July 2003,
16. Cummins J and Ho MW. GM food animals coming. Science in Society 32,
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