Farmed
Animal Watch
A Project of Animal Place
November 20, 2003
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Number #35 Volume 2
CONTENTS
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.pdf
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. "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
23. "Clone Products Okay to Eat," The Scientist, Jack Lucentini,
Oct. 31, 2003. http://www.biomedcentral.com/news/20031031/04/