FDA: final guidance for GE animals
The US Food and Drug Administration on Jan. 15 issued a final guidance for
industry on the regulation of genetically engineered (GE) animals under the new
animal drug provisions of the Federal Food, Drug and Cosmetic Act
The guidance, titled "The Regulation of Genetically Engineered Animals
Containing Heritable rDNA Constructs," clarifies the FDA's statutory and
regulatory authority, and provides recommendations to producers of GE animals to
help them meet their obligations and responsibilities under the
Genetic engineering generally refers to the use of recombinant DNA
(rDNA) techniques to introduce new characteristics or traits into an organism.
When scientists splice together pieces of DNA and introduce a spliced DNA
segment into an organism to give the organism new properties, it is called rDNA
technology. The spliced piece of DNA is called the rDNA construct. A GE animal
is one that contains an rDNA construct intended to give the animal new
characteristics or traits.
"Genetic engineering is a cutting edge
technology that holds substantial promise for improving the health and well
being of people as well as animals. In this document, the agency has articulated
a scientifically robust interpretation of statutory requirements," said Randall
Lutter, Ph.D., deputy commissioner for policy. "This guidance will help the FDA
efficiently review applications for products from GE animals to ensure their
safety and efficacy."
The FDA released the draft guidance in September
2008 with a 60-day public comment period, and received about 28,000 comments.
The agency has summarized and responded to these comments on the website listed
below. The FDA's Center for Veterinary Medicine (CVM) has been working with
developers of GE animals on both early stage and more mature
"At this time, it is our intent to hold public scientific
advisory committee meetings prior to making decisions on GE animal-related
applications" said Bernadette Dunham, D.V.M., Ph.D., director of
Safe for food consumption and animal health
FFDCA defines "articles (other than food) intended to affect the structure or
any function of the body of man or other animals" as drugs. An rDNA construct
that is in a GE animal and is intended to affect the animal's structure or
function meets the definition of an animal drug, whether the animal is intended
for food, or used to produce another substance.
Developers of these
animals must demonstrate that the construct and any new products expressed from
the inserted construct are safe for the health of the GE animal and, if they are
food animals, for food consumption.
The guidance also describes the
manufacturer's responsibility in meeting the requirements for environmental
review under the National Environmental Policy Act.
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