FARMED ANIMAL WATCH
http://www.FarmedAnimal.net
OBJECTIVE INFORMATION FOR THE THINKING ADVOCATE
November 20, 2003
Number 35, Volume 2
SPECIAL REPORT: ANIMAL CLONING - CONSIDERING THE RISKS
1. The FDA'S Risk Assessment of Animal Cloning
2. Risks to Animals
3. Health Issues of Older Cloned Animals
4. Additional Animal Risk Concerns
5. Benefits to Animals
6. Food Safety
7 . The Offspring of Clones
8. Limited Information; Advisory Panel Response
9. FDA Reaction
10 Industry/Political Pressure
11 Ethical Issues
12 Genetic Engineering
1. THE FDA'S RISK ASSESSMENT OF ANIMAL CLONING
Following the Halloween release of its preliminary risk
assessment on animal cloning {1} , the Food and Drug Administration
(FDA) conferred with its Veterinary Medicine Advisory Committee
(VMAC) at a public meeting on Nov. 4th {2 (see also #4:
http://tinyurl.com/v97e
)}. The document, an 11-page draft executive summary
of an estimated 300-page report on published studies and
data submitted by cloning companies, assessed health risks
to animals and potential food safety risks to humans {3}.
It compared the risks of cloning to those of other "assisted
reproduction technologies" (ARTs, e.g., artificial
insemination), concluding that although risks to animals
occur more frequently with cloning they are not different
in type ("quality"). It also concluded, with relatively
high confidence, that "Edible products from normal,
healthy clones or their progeny do not appear to pose increased
food consumption risks relative to comparable products from
conventional animals"{1}. Last year, the National Academy
of Sciences (NAS) Committee on Animal Biotechnology said
that, although food from cloned animals posed a low level
of food safety concern, it would be prudent to have more
data. The committee deemed animal welfare to be a serious
concern {4, 5 (see also #1 of: http://tinyurl.com/vbxx
)}.
2. RISKS TO ANIMALS
Among the risks to animals the FDA identified were: a high
failure rate with clone embryos, oversized fetuses, a low
frequency of live normal births, neonatal respiratory failure
and heart disease {1, and see 7}. Most clones do not survive
to birth, and of those who do many die within a few days.
A Washington Post science reporter elaborated: "Many
are monstrously overweight -- several times their normal
size -- and filled with fluids to the point of looking like
they're about to burst. Others are born with normal bodies
but big, hideous, so-called ‘bull heads.' Others look
okay on the outside but have peculiar abnormalities of the
heart, lungs or other organs -- including livers that are
mysteriously filled with fat -- or defective thymus glands
that blunt normal development of the animals' immune systems"{6}.
Earlier, the FDA had noted that repeatedly subjecting individual
animals to invasive procedures in order to obtain eggs for
cloning is likely to cause them pain and distress {7}. Large
Offspring Syndrome also puts the females used to gestate
cattle and sheep clones at increased risk for difficult
pregnancies and caesarean sections {1}. Other health problems
in cloned animals include pneumonia, brain lesions, skeletal
malformations, and underdeveloped blood systems {8 (and
see #4: http://tinyurl.com/v97e )}. At the meeting, in response
to the FDA's claim that the frequency of live normal births
appears to be increasing as cloning technology advances,
Dr. Michael Appleby of The Humane Society of the U.S. stated:
"Yes, it is increasing from very, very bad to very
bad" {8}.
3. HEALTH ISSUES OF OLDER CLONED ANIMALS
While the report noted that some cloned animals have also
died during the juvenile period from congenital abnormalities
or failure to thrive, the FDA stated: "By the time
clones reach adolescence, however, anomalies that may have
been noted at birth are generally resolved and the clones
are as normal and healthy as their conventional counterparts"{4}.
Others, however, including New Scientist magazine, report
that many cloned animals have abnormalities that are not
initially apparent. Evidence shows that cloned animals -including
Dolly, the famous cloned sheep- have shorter lifespans and
are more susceptible to disease {9}. For example, even among
bovine clones who survived the neonatal period, one-third
of them died by the age of one year {8}. Michael Hansen,
with the Consumer Policy Institute, cited a study that found
cloned mice appeared to have an immune system defect. The
study suggested that some effects of cloning are not apparent
in the days, weeks or even years after birth. Hansen said
that conclusions about the normalcy of surviving cloned
animals need to be based on detailed molecular analyses
of tissue from adult cloned animals rather than superficial
clinical examinations {10, and see 23}. Both Appleby and
Hansen called attention to a relatively recent case not
mentioned by the FDA in which 3 cloned pigs died of heart
failure just prior to reaching 6 months of age. The lead
scientist in the study said "It was totally shocking,"
and dubbed the fatalities "Adult Clone Sudden Death
Syndrome." The novel cloning method that had been used
resulted in 2-3 times more animals surviving the initial
few days of growth than had been achieved with other methods
{11}.
4. ADDITIONAL ANIMAL RISK CONCERNS
Richard Wood of Food Animal Concerns Trust (FACT), a consumer
advocate on the panel, questioned the appropriateness of
using ARTs as a benchmark instead of comparing conventional
breeding {12}. According to a review article on cloning,
the proportion of embryos which developed to become live
young was between 0 & 4%, a figure far lower than that
for other ARTs {10}. Appleby pointed out that currently
employed artificial selection methods have contributed to
numerous production-related diseases, such as mastitis in
cows, skeletal problems in chickens and turkeys, osteoporosis
in hens, and stress susceptibility in pigs. Cloning would
exacerbate this by copying the animals in which these problems
are the worst, those with maximum production. (According
to a professor at Texas A&M , many cloned animals have
not been as "high performance" as those whom they
have been cloned from {13}.) He also cautioned against equating
increased production with improved production {8}.
The FDA found no differences in overall behavior of juvenile
and adult animal clones compared to non-cloned animals {4}.
However, researchers at North Carolina State University
have reported that cloned animals can have the same degree
of variability in both physical appearance and behavior
as do normally bred animals {14}.
5. BENEFITS TO ANIMALS
The FDA said cloning has the potential to improve the welfare
of farmed animals by eliminating pain and suffering from
disease by selecting for disease-resistance {7}. However,
some scientists warn that large populations of cloned animals
could hinder disease control. Dr. Peter Rosset of the Institute
for Food and Development Policy explains "Putting cloned
animals in cramped quarters in a factory farm runs counter
to the basic epidemiology of disease control" {9}.
When asked to comment on this, a spokesperson for the Biotechnology
Industry Organization responded "We don't have a whole
lot of information on that yet. We usually look to the FDA"{9}.
Reducing the number of unwanted animals was presented as
another benefit of cloning by, for example, ensuring the
creation of animals of a specific gender {7}.
6. FOOD SAFETY
Due to the limited availability of data, the FDA based its
decisions about the safety of cloned animals in the food
supply on certain assumptions. It assumed that all clones
and their products would be subjected to the same regulations
as non-cloned animals. Therefore it only considered cloned
animals who appeared healthy on the basis that local, state,
and federal "rules exclude frankly malformed, diseased,
and otherwise unhealthy animals from the human food supply."
The agency based its determination that food from cloned
animals is probably safe on the hypothesis that a healthy
animal is likely to produce safe food products {1}. "[I]t's
hard to imagine that healthy animals would somehow be capable
of producing unsafe food," contended Stephen F. Sundlof,
the director of the FDA's Center for Veterinary Medicine.
"No scientist I've talked to can come up with any rational
theory of how that could possibly occur," he said {5}.
The FDA report also noted that dying or euthanized clones
who enter the food supply via rendering would not likely
pose risks greater than those from non-cloned animals if
they met all of the conditions imposed for them {1}.
Appleby corrected the FDA on its faulty assumption that
sick animals do not get into the food supply (8, and see
#4: http://tinyurl.com/vd7e
). Hansen called the FDA's assumptions "amazing leaps
of logic," noting "If one agrees that an animal
that looks healthy must be safe to eat, then we have no
need of an entire HACCP [meat inspection] system, because
all health hazards would be visible and obvious" {10}.
Hansen also questioned the FDA's attention only to qualitative
and not quantitative differences, noting that the assessment
had not taken into account frequency and incidence of disease,
bacterial infection, allergens, etc {3}. He reiterated the
NAS assertion that stress from developmental problems associated
with cloning could cause the shedding of pathogens in feces,
resulting in higher contamination levels of meat from clones
{12}.
7. THE OFFSPRING OF CLONES
While some farmed animal clones have produced offspring,
very few have lived to reproductive age. The FDA assumes
that any genetic abnormalities caused by cloning would not
be passed on to clone offspring. Relying on biological assumptions,
"limited but consistent" empirical observations
of the species evaluated, and evidence from cloned mice,
the agency further reasoned that edible products from the
offspring of clones are likely to be as safe to eat as corresponding
products from non-cloned animals {1}. Hansen disputed the
normality of cloned animals' offspring by citing contrary
published research {10}.
8. LIMITED INFORMATION; ADVISORY PANEL RESPONSE
The VMAC panel was expected to rubber-stamp the agency's
opinion on the safety of food from animal clones {15}. Instead,
several were deeply troubled by the lack of scientific evidence
supporting the report. "The assumption made was that
there would be no problem, but they didn't present any real
evidence one way or the other," one scientist on the
panel said afterward. "Most of the data presented this
week was based on the result of one company's work,"
he added {2}. Despite the high degree of confidence the
FDA stated it had in its conclusions, the report acknowledged
that much of its opinion was based on single, small studies
with confounding factors, "compelling evidence"
from experiments on mice, and biological assumptions. The
agency had only one study on the composition of milk from
cloned animals and none on meat {1, and see #2 of: http://tinyurl.com/o8k6
}. Industry groups also expressed concern, including the
International Dairy Foods Association {16}, and a spokesperson
for the National Food Processors Association who also pointed
out that the FDA is relying on industry data generated by
cloning companies {17}. Carol Tucker Foreman, with Consumer
Federation of America, noted that no feeding studies have
been done to realize the consequences of long-term consumption.
Hansen admonished the FDA for "a risk assessment that
appears to be based largely on speculation and scientific
theory, not on data." He called the framework used
for the assessment "highly questionable and unscientific"{15}.
According to The Washington Post, 8 of the 10 panel members
concurred with the FDA opinion on the safety of animal products
from animal clones, but the panel deadlocked 5:5 on whether
the FDA had properly characterized the risks to animals
{11}. According to The New York Times, the panel said there
wasn't enough data to support the FDA's conclusion on either
food safety or animal risk {3}. The Post reported: "Committee
members called for a far more rigorous assessment of the
risks and the potential level of suffering for cloned animals"{18}.
9. FDA REACTION
The FDA usually follows the guidance of its advisory panels
but is not required to do so {18}. It still plans to make
the complete risk assessment available for public comment
before the end of the year. The agency is under pressure
from the industry to treat meat and dairy products from
animal clones and their offspring like conventional products
rather than regulate them as it does drugs{2}. The budding
cloning industry is not well financed, and several companies
have already sold out or folded {18}. [One meeting attendee
speculated aloud that the FDA announcement was intended
to elicit a financial infusion for the industry.] It has
vigorously fought expanded oversight by any agency {5}.
If the FDA determines that cloning does not pose a hazard,
food from cloned animals may not be subjected to special
regulations {19}. (A staff report released in late October
said the FDA's review had turned up no evidence that food
derived from cloned animals should be regulated or even
labeled {2, 20}.) The agency intends to also release a document
by next spring on the potential marketing [e.g., labeling]
options of food from animal clones or their offspring {12}.
10. INDUSTRY/POLITICAL PRESSURE
The agency has been criticized by scientists and others
for making premature statements that have resulted in headlines
proclaiming food from cloned animals to be safe {9, 8}.
Foreman charged the FDA with putting cloning on the fast-track
for approval despite widespread anti-cloning sentiment among
the U.S. public {9}. "FDA prides itself on being a
science driven agency but in this case it seems to have
been driven by political pressure to promote animal cloning
than to promote public health," she said {21}. (The
biotechnology industry is closely aligned with the Bush
administration {5}.) VMAC panel member Wood (see section
4) questioned whether the FDA is the only agency with the
authority to regulate food derived from cloned animals {2}.
There appears to be no federal law or policy empowering
the government to prevent cloning on the basis of animal
welfare concerns {18, 5}. Accommodating these concerns could
require new legislation {5}. Appleby urged the FDA to investigate
more effective mechanisms than the voluntary moratorium
presently in place to prevent products from cloned animals
being marketed {8}. Foreman and Hansen joined him is urging
a brake on the technology.
11. ETHICAL ISSUES
In announcing the risk assessment, the FDA said that although
the document did not specifically address ethical issues
the agency was not overlooking them {4, 20}. Both Appleby
and Foreman criticized the FDA for addressing food safety
concerns without first having considered the ethical implications
of cloning. The NAS report deemed it important for the government
to recognize and address moral and social concerns raised
by animal cloning {19, 21}. Most scientists, including some
conducting animal cloning research, have ruled out reproductive
cloning of humans as inherently dangerous given the poor
health of other cloned animals {22, 11}. Appleby noted that
the FDA has stated that if it found "human subjects
are or would be exposed to an unreasonable and significant
risk of illness or injury" it would be sufficient reason
to put a study on clinical hold. He urged the agency to
exert its authority to prevent unnecessary suffering by
extending the same protection to animals {8}. In addition
to the risks to animals, Appleby and Foreman pointed out
that the U.S. is already glutted with meat and milk and
is subsidizing production. They argue that the technology
will only benefit large corporations while further exacerbating
the loss of small farms, and that poor countries won't be
able to afford it either {7, 9, 23}. Foreman called on the
Bush administration to submit for broad public discussion
questions addressing "the moral and ethical issues
inherent in making basic changes in sentient beings"
{5, 21}. Opinion polls have consistently shown that most
Americans oppose animal cloning {21, see also #2: http://tinyurl.com/o8k6
}.
12. GENETIC ENGINEERING
The FDA's determination on cloning will also guide future
decisions on genetic engineering. (Cloning involves using
cells of one animal to make a duplicate, whereas genetic
engineering entails combining the genes of different animals/species)
{7}.
REFERENCES
1. "Animal Cloning: A Risk Assessment" (draft
executive summary), The Food and Drug Administration, Oct.
31, 2003.
http://www.fda.gov/cvm/index/cloning/CLRAES.doc
2. "More Clone Data Needed," The Scientist, Merrill
Goozner, November 10, 2003.
http://www.biomedcentral.com/news/20031110/05
3. "Panel Doubts Finding On Cloned-Food Safety,"
The New York Times, Elizabeth Olson, November 5, 2003.
http://www.nytimes.com/2003/11/05/health/05CLON.html
4. "FDA Issues Draft Executive Summary of its Assessment
of Safety of Animal Cloning," Food And Drug Administration,
October 31, 2003.
http://www.fda.gov/bbs/topics/NEWS/2003/NEW00968.html
5. "FDA Says Cloned Animals Are Safe as Food,"
Washington Post, Justin Gillis, October 31, 2003
http://tinyurl.com/vqxy
or http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A44602-2003Oct30¬Found=true
6. "At Stake on Your Table," The Washington Post,
Rick Weiss, November 9, 2003.
http://www.washingtonpost.com/wp-dyn/articles/A14363-2003Nov7.html
7. "Cloning: Revolution or Evolution in Animal Production?"
FDA Consumer Magazine, Linda Bren, May-June 2003.
http://www.fda.gov/fdac/features/2003/303_clone.html
8. Verbal and written comments to the FDA's Veterinary Medicine
Advisory Committee consultation on cloning, The Humane Society
of the United States, Dr. Michael Appleby (verbal comments
co-written by Tamiko Thomas), November 9, 2003.
See also "HSUS Asks The FDA to Ban Sales of Products
From Cloned Farm Animals," The Humane Society of the
United States, October 9, 2002.
http://www.hsus.org/ace/15431
9. "Questions of Food Safety Dog Cloned Beef,"
Inter Press News Service, Nov. 11, 2003.
http://www.ipsnews.net/interna.asp?idnews=21041
10. "Testimony Before the Veterinary Medicine Advisory
Committee," Consumer Policy Institute, Michael K. Hansen,
November 4, 2003.
11. "Adult Clones in Sudden Death Shock," Nature,
Helen Pearson, 27 August 2003.
http://www.nature.com/nsu/030825/030825-2.html
12. "Panel: Cloning Conclusion Premature," Newsday,
Earl Lane, November 11, 2003.
http://www.newsday.com/news/health/ny-dstop3536487nov11,0,5861373.story
13. "Sales of Cloned Cattle Multiply in Texas,"
Associated Press (USA Today), 11/3/2003.
http://www.usatoday.com/tech/news/2003-11-03-cloned-cattle-sales_x.htm
14. "Cloned Pigs Differ from Originals in Looks and
Behavior," North Carolina State University, April 14,
2003.
http://www.ncsu.edu/news/press_releases/03_04/113.htm
15. "Cloned Food: More Study Needed,"WebMD Medical
News, Daniel J. DeNoon & Jeanie Lerche Davis (reviewed
By Brunilda Nazario, MD), November 05, 2003.
http://my.webmd.com/content/article/76/90159.htm
16." IDFA Concern about Milk from Cloned Cows,"
US Ag Net, 11/06/2003. http://www.wisconsinagconnection.com/story-national.cfm?Id=1200&yr=2003
17. "FDA Panel: Data Not in on Safety of Clones' Meat,"
USA Today, Elizabeth Weise, November 5, 2003.
http://www.usatoday.com/news/nation/2003-11-04-clonedmeat-usat_x.htm
18. "FDA Panel Backs Cloning In Agriculture,"
Washington Post, Michael Barbaro and Justin Gillis, November
5, 2003.
http://www.washingtonpost.com/wp-dyn/articles/A544-2003Nov4.html
19. "FDA: Food from Animal Clones Safe to Eat,"
Associated Press (CNN), October 31, 2003.
http://www.cnn.com/2003/HEALTH/10/31/clone.food.ap/index.html
20. "Cloned Products Could Blend into Food Supply,"
The Los Angeles Times, James Gerstenzang, November 1, 2003.
http://tinyurl.com/tje5
or http://www.latimes.com/news/nationworld/nation/la-na-clone1nov01235430,1,585341.story?coll=la-headlines-nation-manual
21. "Statement of Carol Tucker Foreman Before the FDA
VMAC Committee," Consumer Federation of America, November
4, 2003.
"CFA's Carol Tucker Foreman on FDA's Risk Assessment
on Animal Cloning," Consumer Federation of America,
October 31, 2003.
http://www.consumerfed.org/103103_cloning.html
22. "Clone Products Okay to Eat," The Scientist,
Jack Lucentini, Oct. 31, 2003. http://www.biomedcentral.com/news/20031031/04/
23. "Lots of Animals Cloned, but Nature Doesn't Make
it Easy; Monkeys? Forget it," Associated Press (The
News & Observer), Malcolm Ritter, Nov. 9, 2003.
http://newsobserver.com/24hour/science/story/1047676p-7354480c.html
**********************************
Mary Finelli, Editor
Farmed Animal Watch is a free electronic news digest of
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