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NIH Publishes Revised Guidelines for Research Involving Recombinant DNA Molecules

"NBIAP News Report." U.S. Department of Agriculture (August 1994)

On July 6, 1994, the National Institutes of Health (NIH) published in the Federal Register, Vol. 59, pp. 34496-34547, a new, revised set of "Guidelines for Research Involving Recombinant DNA Molecules."

The original NIH Guidelines published in 1976 specified laboratory practices for constructing and handling recombinant DNA (rDNA) molecules and organisms containing them. At that time, rDNA research involved only microorganisms; those containing rDNA were prohibited outside the laboratory. Since then, rDNA techniques increasingly have been used for research with plants and animals, although containment procedures for large organisms were not covered in the Guidelines.

In 1986, work began on developing new appendices that would cover research involving plants in greenhouses and animals in containment facilities (barns). The revised Guidelines published this month represent the culmination of almost eight years of work.

The most important advancement of the new Guidelines is to bring out Appendices P & Q, which specify physical and biological containment conditions and practices for experiments involving rDNA-containing plants, plant-associated microorganisms, and small animals.

Appendix P establishes four biosafety levels, designated BL1-P through BL4-P, which confer increasing levels of containment. Revisions to Section III of the Guidelines specify which biosafety levels are appropriate to described classes of experiments or organisms.

At their June 1994 meeting, the NIH-RAC approved an action to delete Appendix L, which requires NIH approval for release into the environment of genetically engineered plants. Due to the long lead time needed for administrative clearance, however, the recently published revised Guidelines had been submitted before the June meeting. Thus, the current version still includes the text of Appendix L. Official notice of the action to delete Appendix L is expected to appear soon in the Federal Register; after that, print and electronic copies of the Guidelines distributed by the NIH Office of Recombinant DNA Activities will not include it.

In actuality, Appendix L had already been circumvented by an action under the Guidelines published August 24, 1987. In a modification of Section I-A, experiments that came under the jurisdiction of another federal agency no longer needed NIH review or approval once they were approved by the other agency. This action, in accord with the Coordinated Framework for Regulation of Biotechnology, effectively relinquished jurisdiction for field tests of genetically modified organisms to APHIS and the EPA.


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