Supplement to minutes, Agricultural Biotechnology Research Advisory Committee : guidelines recommended to USDA by the Agricultural Biotechnology Research Advisory Committee, December 3-4, 1991.

  • United States. Agricultural Biotechnology Research Advisory Committee.
Date:
[1991]
Catalogue details

Licence: Public Domain Mark

Credit: Supplement to minutes, Agricultural Biotechnology Research Advisory Committee : guidelines recommended to USDA by the Agricultural Biotechnology Research Advisory Committee, December 3-4, 1991. Source: Wellcome Collection.

    12/96 (page 4)
    rearrangement of nucleic acids from the nucleotide sequences that are moved. III-A-4. Microorganisms resulting from deletions, rearrangements, and amplifications, within a single genome, including its extra-chromosomal elements. Rearrangements are translocations and inversions of nucleotide sequences in the genome. This exclusion does not apply if the microorganism is deliberately modified to have (i) increased virulence or toxin production, (ii) significant changes in competitive ability or environmental requirements, or (ili) phenotypic properties that are harmful to humans or would adversely alter the environment. IlI-A-5. Organisms modified by the introduction of non-coding, non- expressed nucleotide sequences that cause no phenotypic or physiological changes in the recipient microorganisms. Non-coding, non-expressed nucleotide sequences that cause no phenotypic or physiological changes in the recipient organism means the nucleotide sequences are not transcribed and are not involved in gene expression or replication and include linkers, homopolymers, adaptors, and flanking sequences. III-B. Research Subject to Regulations Research involving introduction into the environment of many of the organisms included within the scope of these guidelines is subject to the jurisdiction of a Federal regulatory agency and requires prior approval or clearance. This includes, for example, regulation by the Animal and Plant Health Inspection Service, USDA of plant pests under the Federal Plant Pest Act and Plant Quarantine Act and the regulation of veterinary biologics and organisms and vectors that may cause infectious diseases in animals under the Virus-Serum-Toxin Act and the Animal Quarantine Statutes. The U.S. Environmental Protection Agency regulates microbial pesticides under the Federal Insecticide, Fungicide and Rodenticide Act and other microorganisms under the Toxic Substances Control Act. Questions concerning jurisdiction of Federal agencies may be addressed to OAB. Although the guidelines may be useful to investigators preparing submissions to regulatory agencies, adherence to the Guidelines should not be viewed as a substitute for full compliance with all regulatory requirements. Experiments receiving regulatory approval by USDA or EPA are considered to automatically comply with the Guidelines. IV. General Information The Guidelines are based upon current knowledge and practices for safe planned introduction of genetically modified organisms into the environment. USDA will periodically revise the Guidelines in accordance with the amendment procedures in section XI to reflect new scientific information.