The United States Food & Drug Administration has opened the door for the
development of genetically modified animals, calling for public comment on
how to regulate their development.
The guidance document is intended to clarify FDA's regulatory authority in
this field, as well as the requirements and recommendations for producers of
GM animals and products derived from GM animals.

The comment period for the draft guidance, titled "The Regulation of
Genetically Engineered Animals Containing Heritable rDNA Constructs," runs
for 60 days and closes Nov. 18. The 25-page document is available online at
www.fda.gov/cvm/GEAnimals.htm.

"GE animals hold great promise for improving human medicine, agriculture,
the environment and the production of new materials, and FDA has long been
involved in their scientific evaluation," said Dr Randall Lutter, deputy
commissioner for policy.

"Our guidance provides a framework for both GE animals and products made
from them to reach the market."

GE animals can be divided into several classes, based on their intended use.

They include animals that produce human or animal pharmaceuticals (biopharm
animals); animals that serve as models for human diseases; animals that
produce high-value industrial or consumer products, such as fibres; and
food-use animals with new traits such as improved nutrition, faster growth
or lower emission levels of environmentally harmful substances (such as
phosphate in their manure).

Using the animal drug provisions of the Federal Food, Drug & Cosmetic Act,
FDA's Center for Veterinary Medicine (CVM) has been working with developers
of GE animals to make them aware of their responsibilities to ensure that
food from these animals does not enter the US food supply unless the FDA has
authorized such use.

The US Department of Agriculture's Animal & Plant Health Inspection Service
(APHIS) is also seeking information from the public and industry about
whether additional consideration is needed when genetically engineered
animals are imported or moved across the country.

"Genetic engineering technology is expanding and evolving at an incredible
rate," said Cindy Smith, APHIS administrator.

"We want to ensure that APHIS has not only sought the public's thinking but
also all available information as we consider the potential effects of GE
animals on the US livestock population and what our role should be in
overseeing this developing industry."

APHIS is requesting information on research conducted or planned on GE
animals as well as the importation and movement of GE animals amid the US
livestock population.

APHIS is also seeking input on actions and approaches that should be
considered under the Animal Health Protection Act that would complement
draft guidance issued for public comment by the Food & Drug Administration.
www.checkbiotech.org