FDA Is Set To Approve Milk, Meat From Clones
Pastor Dale Morgan
FDA Is Set To Approve Milk, Meat From Clones*
By Rick Weiss
Washington Post Staff Writer
Tuesday, October 17, 2006; A01
Three years after the Food and Drug Administration first hinted that it
might permit the sale of milk and meat from cloned animals, prompting
public reactions that ranged from curiosity to disgust, the agency is
poised to endorse marketing of the mass-produced animals for public
consumption.
The decision, expected by the end of this year, is based largely on new
data indicating that milk and meat from cloned livestock and their
offspring pose no unique risks to consumers.
"Our evaluation is that the food from cloned animals is as safe as the
food we eat every day," said Stephen F. Sundlof, the FDA's chief of
veterinary medicine, who has overseen the long-stalled risk assessment.
Farmers and companies that have been growing cloned barnyard animals
from single cells in anticipation of a lucrative market say cloning will
bring consumers a level of consistency and quality impossible to attain
with conventional breeding, making perfectly marbled beef and reliably
lean and tasty pork the norm on grocery shelves.
But groups opposed to the new technology, including a coalition of
powerful food companies concerned that the public will reject
Dolly-the-Lamb chops and clonal cream in their coffee, have not given up.
On Thursday, advocacy groups filed a petition asking the FDA to regulate
cloned farm animals one type at a time, much as it regulates new drugs,
a change that would drastically slow marketing approval. Some are also
questioning the ethics of a technology that, while more efficient than
it used to be, still poses risks for pregnant animals and their newborns.
"The government talks about being science-based, and that's great, but I
think there is another pillar here: the question of whether we really
want to do this," said Carol Tucker Foreman, director of food policy at
the Consumer Federation of America.
That there is a debate at all about integrating clones into the food
supply is evidence of the remarkable progress made since the 1996 birth
of Dolly, the world's first mammalian clone, created from an udder cell
of an anonymous ewe.
Scientists have now applied the technique successfully to cattle,
horses, pigs, goats and other mammals. Each clone is a genetic replica
of the animal that donated the cell from which it was grown.
Cloning could solve a number of long-standing farm problems. Many prize
males are not recognized as such until long after they have been tamed
by castration. With cloning, that lack of semen would not matter.
Cloning also allows farmers to make many copies of exceptional milk
producers; with natural breeding, cows have only one offspring per year,
and half are males.
In the eyes of many in agriculture, cloning is simply the latest in a
string of advances such as artificial insemination and in vitro
fertilization that have given farmers better control over animal
reproduction.
"Clones are just clones. They are not genetically engineered animals,"
said Barbara Glenn, chief of animal biotechnology at the Biotechnology
Industry Organization.
The FDA agrees with that distinction, Sundlof said. The agency has
already said it will regulate transgenic animals -- those that have been
engineered by adding specific, valuable genes -- in much the way it
regulates pharmaceuticals, under a new category called "New Animal
Drugs." No such animals are currently on the market.
By contrast, proponents say, clones are simply twins, albeit born a
generation apart.
It was October 2003 when the FDA released its first draft document
concluding that clones and their offspring are safe to eat, prompting
several cloning companies to scale up their operations.
But an agency advisory panel and the National Academies, while generally
supportive, raised flags, citing a paucity of safety data.
That, and opposition led largely by the International Dairy Foods
Association, which represents such large, brand-sensitive companies as
Kraft Foods, Dannon, General Mills and Nestlé USA, put FDA approval on
hold. For years the agency has asked producers to keep clones off the
market voluntarily while the issues got sorted out, a delay that
bankrupted one major company and has left others increasingly frustrated.
But now a large collection of new data submitted to the FDA has
revitalized the effort, according to government officials and others.
The biggest new study is a detailed comparison of meat from the
offspring of cloned and conventional boars created by Austin-based
ViaGen Inc., a major producer of cloned farm animals. Company scientists
agreed to share key results with a reporter but withheld details as
required by the journal Theriogenology, which will publish the full
report in its January issue.
Semen from four clones and three conventional boars was used to
inseminate 89 females. A total of 404 progeny (242 from clones) were
raised identically by government scientists at the U.S. Department of
Agriculture's Meat Animal Research Center in Clay, Neb., and slaughtered
when they reached market size. (Because clones are so valuable,
companies for now anticipate sending only their offspring to market.) Of
the 14,036 measures of protein composition, fatty acid profiles and
other meat components done on the offspring of clones by an independent
lab, all but three were within the same range as those of the
conventional animals, and only one was outside what the Agriculture
Department considers normal.
The other large research report came from Cyagra, a cloning company in
Elizabethtown, Pa.
In that study, 80 blood and urine measures, including various hormone
levels, were taken in 10 newborn, 46 weanling and 18 adult clones.
Results were indistinguishable from those obtained from conventional
animals. Then 79 biochemical measurements from three cuts of meat taken
from five male and six female adult clones were compared with those from
matched cuts from conventional animals. Again, no differences were
found, said Cyagra's director of marketing, Steve A. Mower. The results
have been submitted to the FDA and are being reviewed by a scientific
journal.
"The data are very clear," said ViaGen President Mark Walton. "You
really can't tell them apart."
In light of the new findings, and the FDA's near completion of a
complicated, interagency review demanded by the White House Office of
Management and Budget, Sundlof anticipates releasing a formal draft risk
assessment by the end of the year, along with a proposed "risk
management" plan. Those documents would allow the marketing of clones
and their offspring for food and milk after a final period of public
comment.
Unless, that is, the opponents manage to stop the process, which they
are trying to do on two fronts.
One is the petition filed Thursday by the Washington-based Center for
Food Safety. It asks the FDA to regulate clones, not just transgenics,
as New Animal Drugs. It also calls for environmental impact statements
to evaluate the environmental and health effects of each new proposed
line of clones.
"The available science shows that cloning presents serious food safety
risks, animal welfare concerns and unresolved ethical issues that
require strict oversight," the petition states.
Industry scientists derided the petition's safety concerns, built
largely on a theoretical possibility that subtle genetic changes seen in
some clones may alter the nutritional nature of meat. If those genetic
changes were significant, Mower said, they would cause biochemical
changes in milk or meat, none of which have been found.
But issues of ethics and public acceptance are not easily dismissed,
several experts said.
Surveys show that more than 60 percent of the U.S. population is
uncomfortable with the idea of animal cloning for food and milk. The
single biggest reason people give is "religious and ethical," with
concerns about food safety coming in second, said Michael Fernandez,
executive director of the Pew Initiative on Food and Biotechnology, a
nonpartisan research and education project.
Those sentiments are a big concern to dairy companies, which fear that
any association with cloning could harm milk's carefully honed image of
wholesomeness.
Confidential documents from the International Dairy Foods Association,
obtained by The Washington Post, indicate the group has played a key
role in slowing FDA action and propose a strategy for blocking any
future FDA approval.
Association spokeswoman Susan Ruland said the group opted not to adopt
the lobbying strategy described in those documents, which included using
friends in Congress and "continued outreach to the White House."
In any case, Sundlof said, the FDA has no authority to make decisions
based on ethics concerns. Nor is it inclined to call for labeling of
products from clones, as some have demanded. For one thing, clonal meat
or milk would be impossible to authenticate, since there is no way to
distinguish them from conventional products.
The FDA may already be too late. Several owners of clones have been
selling semen to farm clubs and others vying to grow prize-winning
cattle. Most of those animals end up being slaughtered, sold and eaten,
experts said.
"That you can go online today to any number of different Web sites and
purchase semen from cloned bulls tells you there are cloned sires out
there fathering calves in the food supply," Walton said.
Like it or not, Walton and others said, the clones are out of the barn.