documents on safety of food from animal

Documents on the Safety of Food from Animal Clones

Here is the official document release information from FDA regarding

the Meat and Milk from cloned animals, that we published yesterday.

FOR IMMEDIATE RELEASE

January 15, 2008

Media Inquiries:

Brad Swezey, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

FDA Issues Documents on the Safety of Food from Animal Clones

Agency Concludes that Meat and Milk from Clones of Cattle, Swine, and Goats,

and the Offspring of All Clones, are as Safe to Eat as Food from

Conventionally Bred Animals

After years of detailed study and analysis, the Food and Drug

Administration has concluded that meat and milk from clones of cattle,

swine, and goats, and the offspring of clones from any species

traditionally consumed as food, are as safe to eat as food from

conventionally bred animals. There was insufficient information for

the agency to reach a conclusion on the safety of food from clones of

other animal species, such as sheep.

FDA today issued three documents on animal cloning outlining the

agency's regulatory approach - a risk assessment; a risk management

plan; and guidance for industry.

The documents were originally released in draft form in December 2006.

Since that time, the risk assessment has been updated to include new

scientific information. That new information reinforces the food

safety conclusions of the drafts.

In 2001, U.S. producers agreed to refrain from introducing meat or

milk from clones or their progeny into the food supply until FDA could

further evaluate the issue. The U.S. Department of Agriculture will

convene stakeholders to discuss efforts to provide a smooth and

orderly market transition, as industry determines next steps with

respect to the existing voluntary moratorium.

The agency is not requiring labeling or any other additional measures

for food from cattle, swine, and goat clones, or their offspring

because food derived from these sources is no different from food

derived from conventionally bred animals. Should a producer express a

desire for voluntary labeling (e.g., "this product is clone-free"), it

will be considered on a case-by-case basis to ensure compliance with

statutory requirements that labeling be truthful and not misleading.

Because clones would be used for breeding, they would not be expected

to enter the food supply in any significant number. Instead, their

sexually reproduced offspring would be used for producing meat and

milk for the marketplace. At this time, the agency continues to

recommend that food from clones of species other than cattle, swine

and goat (e.g., sheep) not be introduced into the food supply.

An animal clone is a genetic copy of a donor animal, similar to an

identical twin, but born at a different time. Cloning is not the same

as genetic engineering, which involves altering, adding or deleting

DNA; cloning does not change the gene sequence. Due to their cost and

rarity, clones are intended to be used as elite breeding animals to

introduce desirable traits into herds more rapidly than would be

possible using conventional breeding.

Risk assessment

The risk assessment finds that meat and milk from clones of cattle,

swine, and goats, and food from the sexually reproduced offspring of

clones, are as safe to eat as food from conventionally bred animals.

The science-based conclusions agree with those of the National Academy

of Sciences, released in a 2002 report. The assessment was

peer-reviewed by a group of independent scientific experts in cloning

and animal health. They found the methods FDA used to evaluate the

data were adequate and agreed with the conclusions set out in the

document.

The risk assessment presents an overview of assisted reproductive

technologies widely used in animal agriculture, the extensive

scientific information available on the health of animal clones and

their sexually reproduced offspring, and an assessment of whether food

from clones or their sexually reproduced offspring could pose food

consumption risks different from the risks posed by food from

conventionally bred animals. These conclusions were first presented in

draft documents over a year ago. Since then, the agency has updated

the risk assessment with data that became available, as well as taking

into account comments from the public comment period.

"After reviewing additional data and the public comments in the

intervening year since the release of our draft documents on cloning,

we conclude that meat and milk from cattle, swine, and goat clones are

as safe as food we eat every day," said Stephen F. Sundlof, D.V.M.,

Ph.D., director of FDA's Center for Food Safety and Applied Nutrition.

"Our additional review strengthens our conclusions on food safety."

Risk management plan

The risk management plan outlines measures that FDA has taken to

address the risks that cloning poses to animals involved in the

cloning process. These risks all have been observed in other assisted

reproductive technologies currently used in common agricultural

practices in the United States.

FDA is currently working with scientific and professional societies

with expertise in animal health and reproduction to develop standards

of care for animals involved in the cloning process. Although the

agency is not charged with addressing ethical issues related to animal

cloning for agricultural purposes, FDA plans to continue to provide

scientific expertise to interested parties working on these issues.

Guidance for industry

The guidance for industry addresses the use of food and feed products

derived from clones and their offspring. It is directed at clone

producers, livestock breeders, and farmers and ranchers purchasing

clones, and provides the agency's current thinking on use of clones

and their offspring in human food or animal feed.

In the guidance, FDA does not recommend any special measures relating

to the use of products from cattle, swine, or goat clones as human

food or animal feed. Because insufficient information was available on

clones from other species, e.g., sheep clones, to make a decision on

the food consumption risks, the guidance recommends that food products

from clones of other species continue to be excluded from the human

food supply. The guidance states that food products from the offspring

of clones from any species traditionally consumed for food are

suitable to enter the food and feed supply.

For more information, visit http://www.fda.gov/cvm/cloning.htm.

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