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REGULATION / FOOD: EFSA seeks cloned animal studies

                                 PART I
------------------------------- GENET-news -------------------------------
TITLE:  EFSA seeks cloned animal studies
SOURCE: Food Navigator, France
AUTHOR: George Reynolds
DATE:   02.05.2007

EFSA seeks cloned animal studies

02/05/2007 - The European Food Safety Authority (EFSA) has called on
industry and other groups to submit scientific information as part of
its review on cloned meat.

The request for scientific data is the next phase in forming an opinion
that will be presented to the European Commission, which will then
decide whether to allow cloned products to enter the food supply chain.

EFSA said it encourages submission of peer reviewed data on issues such
as the safety of consumption of meat, milk and eggs from clones and
their offspring. Non peer reviewed data will only be considered if it is
based on scientific evidence and meets adequate quality standards.

EFSA has also asked for information on the comparative physiology of
cloned and conventional animals and their offspring, including
reproductive capacity, is requested. The review will also examine the
technology of cloning, the heath and welfare of animals, as well the
possible environmental implications.

The data must be submitted before the 29 May deadline. EFSA expects to
present the results of the review to the Commission within the next five

If permitted, cloning could provide processors with a better quality of
meat and other products, such as dairy. Cloning offers the possibility
of creating strains of animals with increased disease resistance and
other qualities.

However, consumer reaction against cloned foods is bound to pose a
problem, as happed in the case of attempts to introduce genetically-
modified products in the bloc.

At present in Europe cloning is not a commercial practice and there is
no specific regulation on the authorisation of food products from cloned
animals for human consumption in the EU.

An urgent review of the technology and practice is required though,
following the discovery of calf on cloned cow being raised on a UK farm
earlier this year.

That prompted talks involving food safety officials from the 27 member
states, who decided that milk and meat from cloned animals and their
offspring should be considered in the same way as any other novel food,
such as genetically-modified organisms (GMOs).

EFSA is the scientific risk assessor for novel foods proposed for
introduction in the EU's food chain and so responsibility for providing
an opinion for the Commission to make a final decisions fall on its shoulders.

In the US, debate surrounding the issue gathered momentum in recent
months, after the US Food and Drug Administration (FDA) said it planned
to approve cloning for food production later this year.

The US regulator has issued a consultation proposing to allow the
product into the food chain without the need for labeling.

An independent study in the US indicates that 60 per cent of Americans
would not knowingly eat cloned meat. A 2002 EU survey found that
Europeans were generally against any new foods that had been produced
through new scientific advances - such as GMOs.

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                                 PART II
------------------------------- GENET-news -------------------------------
TITLE:  Implications of animal cloning on food safety, animal health and
        welfare and the environment
SOURCE: European Food Safety Authority, Italy
AUTHOR: Press Release
DATE:   27.04.2007

Implications of animal cloning on food safety, animal health and welfare
and the environment
Invitation to submit data: 27 April - 29 May 2007


The European Commission requested the European Food Safety Authority to
advice on food safety, animal health, animal welfare and environmental
implications of live cloned animals obtained through somatic cell
nucleus transfer (SCNT) technique, their offspring and of the products
obtained from those animals.

Taking into account the complexity of the issue and the broad range of
expertise needed to address this question, EFSA charged its Scientific
Committee to address this request. A working group of experts in the
field is currently being established to prepare a draft opinion.

Data/information needed

EFSA is seeking scientific contributions from Third Parties which could
be useful for the preparation of the opinion. EFSA encourages submission
of peer reviewed data as the most relevant and reliable documents. Non
Peer reviewed data will only be considered if they are based on
scientific evidence and if they meet adequate quality standards, e.g.
publications "in press", technical reports or other scientific documents
or data.

EFSA would appreciate receiving data covering the following issues:
- Technology of transferring the intact nucleus of a somatic cell into
an enucleated oocyte;
- Health and welfare of the foster mother and the cloned animal;
- Characterization of the genetic make-up of the cloned animal,
considering both intranuclear and extranuclear (mitochondrial) genetic
- Comparative physiology of cloned and conventional animals, including
reproductive capacity;
- Safety of consumption of cloned animals and their products (meat, milk
products, eggs);
- Characterization of the genetic make-up of the offspring of the cloned
- Comparative physiology of the offspring of cloned and conventional animals;
- Health and welfare of the offspring of cloned animals;
- Safety of consumption of offspring of cloned animals and their
products (meat, milk products, eggs);
- Environmental implications

Submission of Data:
Dr. Juliane Kleiner
Senior Scientific Officer
Scientific Committee and Advisory Forum Unit
European Food Safety Authority
Largo N. Palli 5a
43100 Parma

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                                 PART III
------------------------------- GENET-news -------------------------------
TITLE:  Consumers flood FDA with over 130,000 comments opposing food from
        cloned animals
SOURCE: The Center for Food Safety, USA
AUTHOR: Press Release
DATE:   03.05.2007

Consumers flood FDA with over 130,000 comments opposing food from cloned
Americans urge agency to adopt a mandatory ban on untested, cloned food

Washington, DC (May 3, 2007) - A coalition of consumer, environmental
and animal welfare organizations today announced the submission of more
than 130,000 comments to the Food and Drug Administration from consumers
who oppose the Agency's proposed plan to introduce food from cloned
animals into the U.S. food supply. The Center for Food Safety, Consumers
Union, Food and Water Watch, The Humane Society of the United States,
the American Anti-Vivisection Society, the Consumer Federation of
America and the Organic Consumers Association joined together to send a
strong, unified message to the FDA that the public opposes the
introduction of cloned animals in food.

Today is the last day of a public comment period that began in January
in response to FDA's proposal to allow products from cloned animals in
the food supply unlabeled. Members of the meat and dairy industries, and
several nonprofit organizations urged the Agency to take time to
consider comments from the widest possible sample of Americans in
consideration of the untested nature of cloning technology.

Recent public opinion polls show the majority of the American public
does not want milk or meat from cloned animals in their food. A December
2006 poll by the Pew Initiative on Food and Biotechnology found that
nearly two-thirds of U.S. consumers were uncomfortable with animal
cloning. The comments submitted today strongly reinforce this national

"Food from cloned animals has no place on our supermarket shelves or on
our dinner tables," said Andrew Kimbrell, Executive Director of the
Center for Food Safety. "FDA needs to heed consumer concerns and ban
animal clones in food."

Another controversial aspect of FDA's plan is that labeling of any kind
on meat or milk products from clones or their offspring would not be
required. This would rob Americans of their right to choose what they
eat and feed their families.

"More than 130,000 people have said 'No' to unlabeled food from clones,"
said Ronnie Cummins of the Organic Consumers Association. "People are
tired of the biotech industry meddling in the food system, tired of
government rubber-stamping approvals, and tired of not having the right
to choose what they eat and feed to their families."

"This flood of public comments should send a strong signal to FDA that
the public is not ready for food from animal clones, and if such food is
put on the market they want it labeled" said Michael Hanson of Consumers
Union, the nonprofit publisher of Consumer Reports, and author of CU's
scientific critique of FDA's risk assessment. "We hope the agency will
listen and rethink their proposal in light of public sentiment and the
many unanswered questions about the science of animal cloning."

Citing animal welfare concerns, The Humane Society of the United States
(HSUS) and the American Anti-Vivisection Society (AAVS) have also asked
the FDA to block sales of products from cloned farm animals and their

"Animals who go through the cloning process suffer terribly. Death and
deformities in cloned animals is the norm, not the exception," said
Tracie Letterman, Executive Director of AAVS. "Just because we can clone
animals for food, doesn't mean we should."
"American consumers are increasingly concerned about the treatment of
animals raised and slaughtered for food," said Wayne Pacelle, President
and CEO of The Humane Society of the United States. "Considering the
numerous studies that have shown that animals in cloning research can
and do suffer, the FDA must disallow cloned animals and their progeny
and surrogate mothers in food production industries."

In its risk assessment of cloned food, the FDA claims to have evaluated
extensive peer reviewed studies on the safety of food from clones to
support its conclusion, yet a recent report issued by the Center for
Food Safety, Not Ready for Prime Time, shows the assessment only
references three peer-reviewed food safety studies, all of which focus
on the narrow issue of milk from cloned cows. What is even more
disturbing is that these studies were partially funded by the same
biotech firms that produce clones for profit. None of the studies focus
on the safety of meat from cloned cows or pigs, or milk or meat from the
offspring of cloned animals, and there was absolutely no data on milk or
meat from cloned goats - all major issues critical to determining the
safety of the proposal.

"FDA's willingness to allow the sale of meat and milk from cloned
animals is yet another example of the Agency's disregard for safety in
the face of industry pressure," said Wenonah Hauter, Executive Director
of Food & Water Watch. "The FDA should not be allowed to use a skimpy
body of evidence to allow this controversial product onto consumers'
dinner tables."

Proponents of animal cloning have asserted that the technology will lead
to better and less expensive dairy and meat products, but Chris Waldrop,
Director of the Food Policy Institute at the Consumer Federation of
America says this simply isn't true, "Consumers don't want or need
cloned animals for food. Cloning will not produce safer or cheaper milk
and meat. Having cloned cows produce more milk won't reduce milk prices.
U.S. farmers already produce more milk than we drink and the government
is required to buy the surplus. Since 1999, dairy support programs have
cost taxpayers over $5 billion."

The FDA has said it will review all the public comments, and will likely
make a decision on food from cloned animals by the end of the year.

Center for Food Safety, Charles Margulis (510) 697-0615, or John
Bianchi, Goodman Media International: (212) 576-2700, x228
Consumers Union: Michael Hansen, (917) 774-3801
Organic Consumers Association: Ronnie Cummins, (218) 226-4164
Humane Society of the United States: Michael Greger, M.D., (301)
American Anti-Vivisection Society: Tracie Letterman (215) 887-0816
Food and Water Watch: Patty Lovera, (202) 797-6557
Consumer Federation of America: Chris Waldrop, (202) 797-8551

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