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| editor's
NOTE |
Jim Riddle
also wrote an extensive (24 page) analysis of
the animal cloning issue for The Organic Center
(www.organic-center.org)
entitled Is
the FDA's Cloning Proposal Ready for Prime Time?
NEW!
The Food and Drug Administration (FDA) public
comment period on its animal cloning review report
ends April. To learn more or to record your preference
on the topic—including—whether food
from cloned livestock should be labeled, click
here.
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On December 28, 2006, the Center for Veterinary
Medicine (CVM) at the US Food and Drug Administration (FDA)
issued a Draft Risk Assessment on meat and milk from cloned
animals.
The FDA concluded that animal cloning, or somatic cell nuclear
transfer (SCNT), “results in an increased frequency
of health risks to animals involved in the cloning process.”
The CVM found that, “surrogate dams are at risk of complications
from birth” and “the frequency of live normal
births appears to be low, although the situation appears to
be improving as the technology matures.” 1
Despite the documented negative impacts on animal health,
the CVM concluded that, “extensive evaluation of the
available data has not identified any food consumption risks
or subtle hazards in healthy clones of cattle, swine, or goats.
Thus, edible products from healthy clones that meet existing
requirements for meat and milk in commerce pose no increased
food consumption risk(s) relative to comparable products from
sexually derived animals.”
In sum, the CVM concluded that meat and milk from healthy
cloned animals are “virtually indistinguishable”
from meat and milk from non-cloned animals with no “biologically
significant” differences in composition.
Disconnects with organic agriculture
According to the FDA report, one of the initial technical
steps in animal cloning is cell fusion. DNA is transferred
from one cell to another. As such, the practice is prohibited
in organic production under the National Organic Program (NOP)
regulation as an “excluded method.”
Excluded methods, which are not allowed in organic production
or processing, are defined as, “a variety of methods
used to genetically modify organisms or influence their growth
and development by means that are not possible under natural
conditions or processes and are not considered compatible
with organic production. Such methods include cell fusion,
microencapsulation and macroencapsulation, and recombinant
DNA technology (including gene deletion, gene doubling, introducing
a foreign gene, and changing the positions of genes when achieved
by recombinant DNA technology). Such methods do not include
the use of traditional breeding, conjugation, fermentation,
hybridization, in vitro fertilization, or tissue culture.”2
Animal cloning is not allowed for organic production under
the NOP for several reasons. Since cloning relies on cell
fusion, it is explicitly prohibited in organic production.
Clearly, it is not possible under natural conditions. It is
not considered compatible with organic production, since cloning
narrows the gene base, while organic production relies on
maintenance of a broad and diverse gene pool. In addition,
cloning is dependent on the use of artificial hormones to
induce labor of surrogate dams. The use of artificial hormones
to induce labor is prohibited in organic agriculture.
Animal husbandry issues
During cloning, an animal’s DNA is inserted into an
egg, where the DNA has been removed. The resulting embryo
is implanted into a surrogate mother, where it forms a genetically
identical copy of the original animal.
But even if two animals have identical genes, they can turn
out differently if those genes are turned on or off at different
times, or are sequenced differently from the original sequence.
These unpredictable genetic variations are linked to the high
failure rate of cloned animals. Many clones die during gestation
or shortly after birth, while some are born with deformed
heads or limbs or problems with their hearts, lungs or other
organs.3
In its report, the FDA admits animal health problems, by
stating that “some animals involved in the cloning process
(i.e., cattle and sheep surrogate dams, and some clones) are
at increased risk of adverse health outcomes relative to conventional
animals.” “Cows and ewes used as surrogate dams
for SCNT-derived pregnancies appear to be at increased risk
of late gestational complications.” “There is
an increased risk of mortality and morbidity in perinatal
calf and lamb clones.”4
The NOP regulation requires organic livestock producers to
establish and maintain preventative livestock health care
practices and accommodate the health and natural behavior
of the animals. Breeding practices, such as cloning, that
result in “adverse health outcomes,” “increased
risks of late gestation complications,” and “increased
risks of mortality and morbidity” do not meet the NOP’s
proactive health care requirements.
Unlabeled clones and the organic market
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Senators
seek explicit
organic ban on cloning
Two U.S. Senators say that since cloning isn't
a natural process, it shouldn't be marketed that
way. Senators Herb Kohl of Milwaukee and Patrick
Leahy from Vermont recently introduced legislation
to bar products that are produced from cloned
livestock from receiving an organic food label
under the National Organic Program administered
by the U.S. Department of Agriculture.
According to emerging legal analysis, prompted
by recent Food and Drug Administration action,
the federal definition of organic food could allow
cloned animal products to be labeled organic.
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While the CVM report concludes that livestock products from
healthy clones are likely to be safe for human consumption,
the FDA has not ruled on whether or not cloned animals and
their products will need to be tracked and labeled.
At a minimum, there should be mandatory tracking and labeling
of cloned animals and animal products as:
- The best way to prevent entry of cloned animals, their
progeny, and products into the
organic food system;
- The only way to conduct long-term epidemiological studies;
- The only way determine with any level of certainty the
effects on human health;
- The best way to protect consumer confidence in the food
system;
- The only way to protect consumers’ rights to know
about the foods they consume;
- The best way to protect the interests of conventional
livestock producers, who are
likely to suffer negative economic impacts from un-segregated
products, similar to
what has happened with losses related to un-segregated GMO
rice.
Introduction of experimental technology
While cloning may prove to be a benign technology in the
long run, there is no shortage of highly productive breeds
and lines of livestock. There is no shortage of meat or milk
in the U.S. In fact, meat and milk markets are often depressed
due to over-production.
This experimental technology introduces an inherent, and
often overlooked, danger—narrowing of the gene base.
Biologically speaking, a species’ survival is directly
linked to genetic diversity. With a broad and deep gene pool,
a species, whether wild or domesticated, is better positioned
to adapt to new disease threats and environmental changes.
For instance, a species with a narrow gene pool can collapse
when animals encounter unanticipated diseases.
The FDA report states, “The Center assumes that if
clones were to pose food consumption risks, the only mechanism
by which those risks could arise would be from inappropriate
epigenetic reprogramming…”5
Despite the fact that many cloned animals die during gestation
or develop abnormally due to a misarranged genetic code, the
FDA assumes that only those animals which appear to be healthy
and normal would enter the human food chain, since they are
“virtually indistinguishable.”
The report goes on to state that animal clones can develop
with apparently normal functions, but with subtle sub-clinical
physiological anomalies. “These could include alterations
in key proteins affecting the nutritional content of food
and leading to dietary imbalances.”6
Because these animals appear to be normal, their products
would find their way into the human food supply. Tracking
of cloned animals is imperative for products from animals
with sub-clinical anomalies to be identified and studied.
The concept of cloned animals and their products being “virtually
indistinguishable,” is similar the doctrine of “substantial
equivalence,” used earlier by the FDA to justify the
untracked and unlabeled introduction of genetically modified
organisms (GMOs). It is not a scientific standard. It is not
even a rational standard, since the products of these technologies
are proprietary for the profit of their developers. It is
an economic and political conclusion weighted to the benefit
of the technology companies and based on a favorable, but
flawed assumption—the similarity of appearance.
Who gains from unregulated cloning?
In the short-term, the presence of unregulated and unlabeled
meat and milk from cloned animals will help further differentiate
organic products from un-segregated conventional livestock
products. This will likely result in more consumers purchasing
organic products.
Corporations who control the technology and proprietary strains
of cloned animals will profit through increased dependence
of farmers on proprietary sources of genetic material.
The absence of tracking or labeling protects technology companies
and users of cloned animals from liability. Without traceability,
the determination of harm, should harm occur, is virtually
impossible.
The Draft Risk Assessment does not address the potential
economic effects of allowing the unregulated use of animal
cloning without traceability or labeling. No other country
has approved food from cloned animals. Unlabeled introduction
of cloning has the potential to seriously diminish consumer
confidence, further depressing domestic and export markets
for conventional livestock products.
A December 2006 poll by the Pew Initiative on Food and Biotechnology
found that 64 percent of consumers said they were uncomfortable
with animal cloning, with 46 percent saying they were “strongly
uncomfortable.” Likewise, an online poll conducted by
the Minneapolis Star Tribune immediately after FDA’s
announcement found that 60 percent of respondents said that
they would not eat food products from cloned animals.
Prior to full approval, a comprehensive economic impact analysis
must be conducted to examine the technology’s impacts
on existing markets for conventional and organic livestock
products. 
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