FDA Says Clones Are Safe For Food


Richard Moore


FDA Says Clones Are Safe For Food
Report Finds No Evidence of Risks
By Rick Weiss
Washington Post Staff Writer
Tuesday, January 15, 2008; A01

A long-awaited final report from the Food and Drug Administration concludes that
foods from healthy cloned animals and their offspring are as safe as those from 
ordinary animals, effectively removing the last U.S. regulatory barrier to the 
marketing of meat and milk from cloned cattle, pigs and goats.

The 968-page "final risk assessment," not yet released but obtained by The 
Washington Post, finds no evidence to support opponents' concerns that food from
clones may harbor hidden risks.

But, recognizing that a majority of consumers are wary of food from clones -- 
and that cloning could undermine the wholesome image of American milk and meat 
-- the agency report includes hundreds of pages of raw data so that others can 
see how it came to its conclusions.

The report also acknowledges that human health concerns are not the only issues 
raised by the emergence of cloned farm animals.

"Moral, religious and ethical concerns . . . have been raised," the agency notes
in a document accompanying the report. But the risk assessment is "strictly a 
science-based evaluation," it reports, because the agency is not authorized by 
law to consider those issues.

In practice, it will be years before foods from clones make their way to store 
shelves in appreciable quantities, in part because the clones themselves are too
valuable to slaughter or milk. Instead, the pricey animals -- replicas of some 
of the finest farm animals ever born -- will be used primarily as breeding stock
to create what proponents say will be a new generation of superior farm animals.

When food from those animals hits the market, the public may yet have its say. 
FDA officials have said they do not expect to require food from clones to be 
labeled as such, but they may allow foods from ordinary animals to be labeled as
not from clones.

Opponents of the approval, including some concerned about the welfare of the 
clones themselves, expressed dismay upon learning about the FDA's intentions.

Joseph Mendelson, legal director of the Center for Food Safety, a Washington 
advocacy group that petitioned FDA to restrict the sale of food from clones, 
said his group is considering legal action.

"One of the amazing things about this," Mendelson said, "is that at a time when 
we have a readily acknowledged crisis in our food safety system, the FDA is 
spending its resources and energy and political capital on releasing a safety 
assessment for something that no one but a handful of companies wants."

Others countered that public opinion and politics should play no bigger role in 
the decision on clones than it should in the approval of a drug or a 

"In fact, cloned animals have been studied much more than naturally produced 
animals," said Cindy Tian, who has analyzed milk and meat from clones at the 
University of Connecticut. "We have more data on them than for any other animal 
that we eat."

Release of the analysis was slowed for years by several forces, including the 
dairy industry, concerned about the potential impact on exports of U.S. whey 
solids, foreign sales of which are growing for use as a protein supplement.

In the past month, as an announcement neared, members of Congress, led by Sen. 
Barbara A. Mikulski (D-Md.), sought to delay approval through legislation.

Trade-related agencies including the Foreign Agricultural Service and the Office
of the U.S. Trade Representative, which for years have struggled to get 
countries to accept U.S. gene-altered crops, also raised red flags.

A final blitz of meetings with FDA officials last week brought grudging 
acquiescence, insiders said. And it is possible, sources said, that even after 
the risk analysis is released, there will be calls for farmers to voluntarily 
refrain from selling products from clones until the trade issues can be 

To create its final risk assessment, the FDA gathered data on nearly all of the 
more than 600 U.S. farm-animal clones produced and hundreds of their offspring, 
as well as many from overseas. But it faced challenges in the process.

Those animals were made by scientists scattered among various universities and 
companies using different methods that in many cases were difficult to compare.

Moreover, many of those animals were not just clones but also had genes added to
them for projects unrelated to food production.

In those cases, it was difficult for FDA reviewers to decide whether any 
problems were caused by those animals being clones or by their particular 
genetic alterations. (The FDA has said it will not approve gene-altered animals 
as food without additional tests for safety.)

Finally, there was the overarching problem of deciding which measures would best
predict whether the food was safe. Most puzzling was whether to take into 
account the subtle alterations in gene activity, called epigenetic changes, that
are common in clones as a result of having just one parent.

In the end, facing the reality that epigenetics have never been a factor in 
assessing the wholesomeness of food, agency scientists decided to use the same 
simple but effective standard used by farmers since the dawn of agriculture: If 
a farm animal appears in all respects to be healthy, then presume that food from
that animal is safe to eat.

Scientists inside and outside the agency studied thousands of pages of 
veterinary reports describing weight, size, organ function, blood 
characteristics and other measures of clones and offspring. For cattle -- the 
animals for which the most data exist -- full health assessments were conducted 
for each of five different stages of the animals' life: fetal, newborn, 
juvenile, sexually mature, and old.

They concluded that newborn cattle are often unhealthy, probably because of 
epigenetic changes. They are usually extremely overweight and have respiratory, 
gastrointestinal and immune system problems. (Cloned pigs and goats are mostly 
healthy from the start.)

But those problems typically disappear within the first weeks or months of life 
as the animals somehow compensate. And since sick clones would not pass muster 
with food inspectors any more than sick conventional animals would, they pose no
concern, the report says.

Studies of cloned farm animal behavior, including mating behavior, also showed 
them to be the same as ordinary animals. (One exception: On one farm, clones 
showed a peculiar preference not for the surrogate mother that gave birth to 
them but to the animal from which they were cloned.)

Scientists also looked at nutrient levels in meat and milk from a few dozen 
cattle and pig clones and hundreds of their progeny, and compared them with 
values from conventional animals. They measured vitamins A, C, B1, B2, B6 and 
B12 as well as niacin, pantothenic acid, calcium, iron, phosphorous, zinc, 12 
kinds of fatty acids, cholesterol, fat, protein, amino acids and carbohydrates 
including lactose.

For almost every measure, the values were virtually the same. The few that 
differed were still within the range considered normal.

Separately, the agency looked at studies in which milk and meat from clones were
fed to animals for up to 3 1/2 months. There was no evidence of health effects, 
allergic reactions or behavioral changes.

In the end, the agency concluded that it did not have enough information to rule
on the safety of food from cloned sheep. It also decided that edible products 
from newborn cattle clones, which often are metabolically unstable, "may pose 
some very limited human food consumption risk."

But it found no safety hazards for meat from healthy cattle clones more than a 
few weeks old, milk from cloned cows, or meat from cloned pigs or goats of any 

"Food from cattle, swine, and goat clones is as safe to eat as that from their 
more conventionally-bred counterparts," the FDA risk assessment concludes.

Looking ahead, the report says FDA is collaborating with veterinary and 
scientific organizations, notably the International Embryo Transfer Society, to 
create a database on the health of new clones, which will help the agency track 
the field as the industry grows.

Working with the FDA, the International Embryo Transfer Society is also creating
the first manual of animal care standards for clones, to be made available to 
farmers and the public later this year.

© 2008 The Washington Post Company

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