committees in the regulatory process, and the present capabilities of the committees to adequately review release proposals.

As agreed with your office, unless you publicly announce its contents earlier, we plan no further distribution of this briefing report until 30 days from the date of this letter. If you have further questions, please contact me at (202) 275-1000. Tabulations of our survey results are given in appendix I. Major contributors to this report are listed in appendix II.

Sincerely yours,

Sarah Frozen Jagger

Sarah Frazier Jaggar
Associate Director

The Chairman of the House Committee on Science, Space and Technology asked us to assess institutional biosafety committees' implementation of federal guidelines applicable to the environmental release of genetically engineered organisms.

Universities, companies, and other organizations using recombinant DNA1 technology in their laboratories established biosafety committees to implement the National Institutes of Health (NIH) guidelines for research involving recombinant DNA molecules. The committees are responsible for reviewing research proposals using this technology to ensure proper containment of recombinant organisms and the safety of laboratory personnel. The biosafety committees were not intended to focus primarily on deliberate releases of genetically engineered organisms in the environment. Now, however, they are required to play an increasing role in reviewing and approving proposed releases.

As requested, this report focuses on the biosafety committees'

membership composition,

functions and activity levels,

implementation of the NIH guidelines for research involving recombinant DNA molecules, and

role in federal regulation of genetically engineered organisms.

In addition, we were asked to report on the involvement of Montana
State University's biosafety committee in a recent environmental release
incident at that university. The incident involved a university
researcher who deliberately released genetically engineered organisms
into the environment without prior notification and approval by his
local biosafety committee or the Environmental Protection Agency (EPA).

In performing our work, we obtained data from three primary sources:
(1) committee membership records on file with the Office of Recombi-
nant DNA Activities (ORDA) in Rockville, Maryland, (2) survey informa-
tion based on responses to a questionnaire sent to 312 chairpersons of
all public- and private-sector biosafety committees registered with ORDA,
and (3) documentary information based on interviews conducted in
Washington, D.C., with federal officials who are knowledgeable about

DNA (deoxyribonucleic acid) is the genetic material found in all living organisms. Every inherited characteristic has its origin somewhere in the code of each individual's complement of DNA. Recombinant DNA technology involves modifying an organism by breaking up and splicing together DNA fragments from other organisms using molecular biology methods.

Introduction

their agency's biotechnology policies. We collected and analyzed data from ORDA'S files. We also conducted 20 interviews with biosafety committee chairpersons and other authorities to develop and refine a questionnaire that was sent to all chairpersons in May 1987. We then analyzed the responses from 261 chairpersons (84 percent responded), which are tabulated in appendix I. In addition, we interviewed agency officials at the Food and Drug Administration (FDA), EPA, the Department of Agriculture's (USDA) Animal Plant Health Inspection Service and Agricultural Research Service, the Department of Energy (DOE), the Office of Naval Research of the Department of Defense, the National Science Foundation (NSF), ORDA, and officials at Montana State University. We conducted our work between January and July 1987 in accordance with generally accepted governmental auditing standards.