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Frequently Asked Questions About Animal Cloning
1. What is cloning?
2. Why do researchers want to clone animals?
3. What are the concerns with animal cloning?
Animal Welfare Concerns
Human Food Safety Concerns
Environmental Concerns
Ethical Concerns
4. What is the difference between cloning and other reproductive technologies already in use?
5. Have food products from cloned animals been approved for human consumption?
6. Why is AAVS petitioning the FDA to regulate cloned animals?
7. Who else has joined the petition to regulate cloned animals?
8. What can I do to help?
1. What is cloning?
Cloning is the term commonly used to refer to a procedure known as somatic cell nuclear transfer (SCNT),
the procedure which was first used to create Dolly the sheep in 1996. In SCNT, the nucleus
(which contains the genetic material of an animal) is removed from an unfertilized egg and replaced
with the nucleus of an adult (somatic) cell from the donor animal to be cloned, ultimately resulting
in an animal that is an almost exact genetic copy of the donor (though some differences remain).
To do this, researchers typically must first inject a female with hormones to induce her to
super-ovulate (produce more eggs than usual) so that they can harvest her eggs, often surgically.
The nuclear transfer is performed and the reconstructed cloned embryos are incubated until they reach
a certain size, at which point they are surgically implanted into surrogate mothers, often several
embryos per surrogate in the hopes that at least one will 'take.' Only a very small percentage of
cloned embryos-typically zero to three percent-will be successfully delivered, usually by
cesarean section. Of those few cloned animals that survive birth, the majority will be of such poor
health, suffering from a variety of physiological abnormalities and deformities, that they die within
a few days. Even the cloned animals that survive for longer have been known to suffer unexpected
health consequences later in life. In fact, an article recently published in The New England Journal
of Medicine stated that "given the available evidence, it may be exceedingly difficult, if not
impossible, to generate healthy cloned animals...."
These serious health problems associated with cloned animals lead to numerous concerns over animal welfare,
the safety of food products from cloned animals, and the ethics of cloning-concerns which need to
addressed by the Food and Drug Administration (FDA).
2. Why do researchers want to clone animals?
Agriculture researchers are interested in cloning livestock such as cows, pigs, sheep, goats, and
poultry primarily for the purposes of breeding to create copies of 'valuable' animals. Currently,
farmers use the animals that have the best genetics for some desired quality such as fast growth,
leaner meat, or high milk production as breeding animals to produce offspring that will have similar
qualities. By cloning these top breeders, farmers want to extend their reproductive potential and
create whole herds or flocks with these uniform characteristics.
Cloning is also used to produce copies of transgenic animals-animals who have been engineered with
genes from another species in order to have better traits for production (such as faster growth,
disease resistance, altered milk or meat products with 'health benefits' for humans, etc); to produce
pharmaceuticals in their milk, blood, urine, or semen (pharming); or to produce tissues and organs
for transplantation into humans (xenotransplantation). If animal cloning is approved, generation
and proliferation of transgenic animals is likely to become the major application of cloning
technology.
3. What are the concerns with animal cloning?
While cheaper, 'healthier' food may sound like a good thing, the important question to ask is, how
should it be accomplished? The answer is not by cloning animals. Animal cloning raises concerns on
numerous levels and there is simply no need to clone animals for food. The remarkable inefficiency of
cloning poses serious threats to animal welfare, as does engineering these animals for ever more
intensive production, which is already associated with great animal cruelty and suffering. The poor
health of cloned animals, combined with the instability and unpredictability of the genetic
manipulations, leads to important concerns about the safety of consuming food products from cloned
animals. The effects of creating uniform herds of animals, and the resulting loss of biodiversity,
have significant implications for the environment and the ability of cloned herds to withstand
diseases. In addition, the majority of Americans have strong ethical objections to cloning animals,
and are concerned that animal cloning will lead to human cloning, that cloning is unreligious, or
that cloning is just not 'right.' These are all concerns which have not yet received adequate
attention or discussion, and which must be addressed before the FDA can make any statement regarding
the acceptability of cloned animals.
Animal Welfare Concerns:
Cloning is an incredibly inefficient technology which results in a tremendous loss of animal life.
Typically, less than one percent of cloning attempts will result in a successful birth, and of those
that are born, only a small percentage are healthy enough to live for more than a few days or weeks.
This means that hundreds of animals suffer as their eggs are harvested, or as they are surgically
implanted with embryos, often repeatedly, in an attempt to produce just one cloned animal.
To clone Dolly, for example, 277 cloned embryos were implanted, only 13 pregnancies resulted, and
only 1 animal was born successfully—Dolly. In a Texas A&M study using cows, 17 percent of 322
SCNTs developed into embryos, of which 26 were successfully implanted. After 40 days of pregnancy,
six fetuses survived. After 290 days, only one survived. This calf had significant metabolic and
cardiopulmonary abnormalities similar to those seen in previous studies, diabetes mellitus, and was
susceptible to severe immune-system deficiencies.
This last study highlights the severe health problems that plague cloned animals. While very little
information about cloned animals is publicly available (due to research confidentiality), it is clear
that abnormalities are the norm, not the exception. Cloned animals suffer from respiratory distress,
hypoglycemia, weakened immune systems, developmental problems, deformities, and a variety of ailments
that claim the lives of most neonates.
'Large Offspring Syndrome' (LOS) is a commonly observed problem with cloned animals in which the
animal is significantly bigger at birth than a conventional animal. It is not uncommon for the animal
to be twice the normal birth weight, and one lamb was reported as being five times the normal birth
weight. This results in an overly painful and stressful labor and delivery for the mother, often
requiring surgical intervention to deliver the baby. In one published study, three of 12 surrogate
mothers died during pregnancy as part of a cattle cloning project. LOS is often accompanied by a
variety of other symptoms as well. Gross abnormalities of organ growth are typical, for example, as
well as breathing difficulties, reluctance to suckle, and sudden perinatal death.
In addition, cloning is often pursued in order to aid in the intensive production of livestock-to
produce animals that grow faster so they can be slaughtered sooner, and to raise more animals in a
smaller space. The rise of 'factory-farming' has already led to serious animal health problems,
including animals that grow so big so quickly that their bones break, and animals that are confined
to spaces so small they cannot even turn around or stretch. To use cloning, with all of the animal
suffering that it entails, to further commodify animals and make them mere machines of manufacture is
a major affront to animal welfare. Moreover, the industrialization of agriculture has driven many
small farmers out of business, concentrating operations to only a handful of large corporations that
are willing to sacrifice welfare and sustainability for profit.
Human Food Safety Concerns:
The health problems associated with cloned animals, particularly those that appear healthy but have
concealed illnesses or problems that appear unexpectedly later in life, have the potential to pose real
risks to the safety of the food products derived from those animals. Ian Wilmut, a lead scientist
involved in the creation of Dolly, has warned that even small imbalances in a clone's hormone,
protein, or fat levels could compromise the safety of its milk or meat.
There have been few published studies, however, that examine the composition of milk, meat, or eggs
from cloned animals or their progeny, or the safety of eating those products. As of 2003, when the
FDA made a preliminary assessment that milk and meat from cloned animals is safe to eat, there had
been only one study on cloned milk, no studies on cloned meat, and no long-term studies. Such an
assessment is clearly premature and based on insufficient evidence.
The FDA has recently reviewed additional studies, though the studies
were carried out by the same researchers interested in getting cloned animals approved for the
marketplace. It is no surprise that the FDA has continued to endorse the safety of cloned foods.
According to a 2005 independent survey, 77 percent of Americans polled were unsure about
the safety of cloned food. The FDA must do a better job to protect consumers and ensure that the food
industry is not brought into disrepute.
Environmental Concerns:
By creating herds of cloned animals that have the same genetic composition, either entirely or with
respect to some particular traits, the diversity of those animals is significantly reduced. As a
consequence, cloned animals and herds may be more susceptible to disease and less able to withstand
an outbreak, which could have serious repercussions for the population as a whole and for the
agriculture industry. The range of potential environmental impacts of the proliferation of cloned
animals has not been thoroughly investigated and is largely unknown and uncertain.
Ethical Concerns:
There are numerous ethical implications associated with cloning. Numerous surveys have shown that roughly two-thirds of Americans
are uncomfortable or disapprove of animal cloning. In a December 2006 national survey conducted for AAVS, for example, 66 percent of respondents said
they were opposed to cloning animals for food, and that number jumped to 88 percent when respondents learned
that cloning involves animal suffering.
In fact, these ethical concerns are
so strong that 63 percent of Americans would not buy food from cloned animals even if it were labeled
as 'safe.'
Several religious groups, including from Protestant, Catholic, Jewish, Muslim, Hindu, and Buddhist
faiths, have rejected animal cloning on ethical grounds. Cloning and genetic engineering are viewed
by these groups as tantamount to 'playing God.'
Many people believe that animal cloning will be used to pave the way for human cloning, particularly
since essentially the same SCNT procedures would be used. Researchers in England and Australia have
already backed a proposal to fuse a human cell to an animal egg to create embryos that are 99.9%
human and 0.1% rabbit. People are concerned that cloning represents a dangerous 'transgression' of
science.
According to a 2005 poll conducted for the Pew Initiative on Food and Biotechnology, 63% of
Americans believe that the federal government should consider ethical issues when making a decision
on cloning and genetic engineering.
4. What is the difference between cloning and other reproductive technologies
already in use?
Cloning is in some ways an extension of assisted reproductive technologies already in use in
agriculture, and in other ways it is a radical departure from how animals have traditionally been
bred.
Selective breeding, in which only those animals with desired traits are chosen for reproduction, has
been used by farmers for centuries. More recently, selective breeding practices have intensified,
aiming for ever greater production and lower costs, often sacrificing animal welfare in the process.
As animals are bred to grow twice as fast or produce three times more milk, they are increasingly
suffering from lameness, udder infections, and other painful production-related problems.
In the past 50 or so years, selective breeding techniques have evolved to include artificial
insemination, in vitro fertilization, and embryo transfer-all involving increasingly greater human
interference and all employed to maximize the reproductive potential of 'valuable' animals. In this
sense, cloning is an extension of these reproductive techniques. And like these techniques, cloning
promises to increase the amount of suffering animals must endure.
However, animal cloning carries far greater risks and loss of life than other reproductive
techniques. With over 99 percent of cloning attempts resulting in death or serious health problems
and deformities, a clone is hardly the same as a natural twin. Despite what proponents of cloning
say, genetic manipulation is an integral component of cloning, and this ratchets up the level of
associated animal welfare and ethical concerns. Moreover, while other assisted reproductive
techniques are currently in use, this does not justify their existence nor does it justify the
introduction of cloning as another tool in the factory farmer's arsenal.
5. Have food products from cloned animals been approved for human consumption?
The FDA has asked for producers of cloned animals to voluntarily withhold these animals from the
market while it reviews the evidence and forms a decision on how to regulate cloned animals. The
FDA conducted a draft risk assessment in 2003 and determined that food products from cloned animals
and their progeny "do not appear to pose increased food consumption risks relative to comparable
products from conventional animals."
However, the FDA was premature in making this assessment, as the determination was based on only one
study of cloned milk. There were no studies of cloned meat, and no long-term studies to determine the
health consequences of consuming milk or meat from cloned animals. In fact, several members of the
FDA's own Veterinary Medicine Advisory Committee stated that the data were insufficient to make an
adequate assessment. The National Academy of Sciences also stated in a 2004 report that the safety
of cloned food could not be asserted because "the paucity of evidence in the literature on this topic
makes it impossible to provide scientific evidence to support this position."
In light of these criticisms, the FDA has been collecting additional data on the comparative
composition of cloned milk and meat. The FDA recently completed its review of these additional
studies and released a formal draft risk assessment on cloned animals in December 2006, along with a
proposed risk management plan. The FDA maintained its position that food from cloned animals is 'virtually indistinguishable'
from food from conventional animals , and thus does not require regulation. However, the data come from the same
producers who are pushing for the FDA to allow commercialization of cloned animals, and there is little incentive
for them to supply the FDA with data that are damaging to their case.
Importantly, FDA Commissioner Lester Crawford stated in 2005 that the "FDA plans to ask the public what moral
and ethical issues it should consider in its upcoming draft risk assessment on using the offspring of clones in food."
Even if the FDA finds that cloned food products are safe to eat, it is critical that the FDA fulfills its promise to
address the serious ethical concerns that Americans have about cloning animals, as surveys indicate that 63 percent
of consumers would not buy food from cloned animals even if it were labeled as 'safe.' Just because a food may
be safe does not mean it should be produced.
The FDA intends to rule that food from cloned animals does not need to be labeled as such. This would
mean that consumers who oppose animal cloning on animal welfare, religious, or moral grounds would be forced to
unwittingly make purchases that violate their ethical principles. Consumers have a right to know how their food
was produced so they can make informed decisions about what they buy and what they feed their families.
AAVS, in collaboration with numerous consumer, animal, environmental,
and relgious organizations, is working with Congressional members on state and federal legislation to require that cloned foods, if they are approved for public sale, be labeled.
6. Why is AAVS petitioning the FDA to regulate cloned animals?
It is likely that the FDA will allow milk and meat from cloned animals to be sold to the public without regulation.
Before food from cloned animals is allowed on the market, however, the serious ethical concerns, including animal
welfare concerns, raised by animal cloning must be addressed. These are important issues that Americans feel strongly
about, and they must be thoroughly examined before any determination is made regarding cloned animals. As a result, in October 2006
AAVS joined with the Center for Food Safety and several other animal welfare, consumer, and environmental
organizations to petition the FDA to establish an ethics Advisory Committee, similar to ones set up to discuss
human genetic technologies, to provide an opportunity for public participation and transparency in the animal cloning debate.
In addition, the petition calls on the FDA to instate a mandatory moratorium on the sale of cloned food until these
issues have been resolved. If the FDA does approve food from cloned animals for the marketplace, the petition asks
that cloned animals be regulated. Regulatory oversight is absolutely necessary to ensure animal, human, and environmental
safety, and would require that cloning be scientifically demonstrated to be safe and effective for animals, that cloned
food products be safe for human consumption, and that the environmental impact of cloned animals be assessed.
See the petition summary for more information.
7. Who else has joined the petition to regulate cloned animals?
In addition to the Center for Food Safety and the American Anti-Vivisection Society, the Consumer Federation of America,
Food and Water Watch, Friends of the Earth, the Humane Society of the United States, the Religious Coalition for Reproductive Choice,
and the Center for Environmental Health have all joined the petition asking the FDA to impose a mandatory moratorium on the sale of
cloned animal products until the ethical and regulatory issues with cloning can be thoroughly examined.
8. What can I do to help?
The FDA will be accepting comments on its draft risk assessment on cloning animals for food until April 2, 2007. You can let the FDA know how you feel about animal
cloning by using our sample letter to submit your comments.
For more information, click on the links below:
Overview
Frequently Asked Questions
Fact Sheet
Point/Counterpoint
News
Additional Resources
Media Kit
AAVS Petitions FDA to Regulate Cloned Animals
Take Action to End Animal Cloning!
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