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Biotechnology

APHIS' Role in Biotechnology

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APHIS uses the term biotechnology to mean the use of recombinant DNA technology, or genetic engineering (GE) to modify living organisms.  APHIS regulates certain GE organisms that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests. Below is a list of the regulatory requirements for genetically engineered organisms and facilities.

Introducing Genetically Engineered Organisms that may be Plant Pests   

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APHIS' Biotechnology Regulatory Services regulates the introduction (importation, interstate movement, and release into the environment) of genetically engineered organisms that may pose a risk to plant health.

Importing or Exporting Genetically Engineered Animals and Animal Products

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APHIS’ Veterinary Services', National Center for Import Export regulates the import, export, and interstate movement of all animals and animal products (e.g., tissues, blood, and semen), including those that are genetically engineered.

Obtaining Licenses for Veterinary Biologics

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APHIS’ Veterinary Services’ Center for Veterinary Biologics regulates veterinary biologics (e.g., vaccines and diagnostic kits), including those developed using genetically engineered organisms. 

Obtaining Registration for Animal Facilities

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APHIS’ Animal Care regulates research facilities used for certain vertebrate animals, including vertebrate animals that are genetically engineered.

Obtaining Other Authorizations from APHIS

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In addition to permits for genetically engineered organisms, there may be other agency requirements based upon other characteristics of the organism or product.

 

 

Last Modified: July 24, 2012

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