Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee.

  • United States. Environmental Protection Agency. Biotechnology Science Advisory Committee.
Date:
1987
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Licence: Public Domain Mark

Credit: Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee. Source: Wellcome Collection.

    15/72 (page 7)
    Report of the Meeting of the Biotechnology Science Advisory Committee; Subcommittee on Definition of Release Into the Environment December 11-12, 1986 Introduction The use of the techniques which have been called the “new’’ biotechnology (recombinant DNA, cell fusion, etc.) has brought to the fore certain issues in assessing the potential impacts of the technology. Among these issues are the definition of what constitutes ‘‘contained’’ and what constitutes ‘‘released’’ to the environment when microorganisms are used to perform certain tasks. In general, “‘contained’’ has been used to mean pro- cedures that occur within a facility where certain equip- ment, procedures and practices are employed to ‘‘con- trol’’ microorganisms. Few facilities, however, ever pro- vide absolute containment; in practice, varying numbers of microorganisms are released when microorganisms are used in facilities such as laboratories or fermentation plants. A number of factors affect the quantities of viable organisms released from a facility during a specific pro- cess. Thus, no absolute standard exists for ‘‘contained”’ or for ‘‘released.’’ Yet for the purposes of understanding and describing the effect of adding microorganisms to en- vironments, and to regulate microbial products, workable definitions of ‘‘contained”’ and ‘‘released’’ are necessary. In order to obtain advice in its efforts to develop a workable definition of ‘‘released’’, the Environmental Protection Agency (EPA) has assembled a group of recognized technical experts as a subcommittee of an Agency-based scientific advisory committee. Those ex- perts met on December 11-12, 1986, at Crystal Mall-2, in Crystal City, VA. This report describes that meeting. A brief review of the history of that technique of the ‘new’’ biotechnology known as recombinant DNA is in- cluded in this report to illustrate how the concepts of ‘““contained”’ and ‘‘released’’ have influenced the over- sight of recombinant DNA technology. The report also describes the format and objectives of the December 11-12 meeting, and includes the minutes and a roster of the ex- perts who participated in the meeting. Most important- ly, the report details the several approaches to defining “‘contained’’ and ‘‘released’’ suggested by the subcom- mittee. History It was the scientists' who engaged in research using the technique called recombinant DNA who first called for assessment of the risks which might be associated with this technique. At an international meeting of scientists in February 1975 at the Asilomar Conference Center, Pacific Grove, CA, the participants agreed recombinant DNA exper- Report of the Biotechnology Science Advisory Committee iments should proceed, provided appropriate physical and biological containment* is utilized. The National Institutes of Health (NIH) was asked? to develop (1) guidance on appropriate physical and bio- logical containment, and (2) the mechanism to evaluate experiments in order to assign appropriate containment. In July 1976, NIH published its Guidelines for Re- search Involving Recombinant DNA Molecules?. These guidelines, which were developed with the assistance of the Recombinant DNA Molecules Advisory Program (later renamed the Recombinant DNA Advisory Com- mittee [RAC]), were based upon containment of or- ganisms containing recombinant DNA. In this original version of the guidelines, intentional release to the environment of organisms constructed us- ing this technique of the ‘‘new’’ biotechnology was con- sidered a special category: experiments involving ‘‘de- liberate release into the environment of any organism con- taining a recombinant DNA molecule’ were ‘‘not to be Mitiated. .:...’* In the first revision of the NIH Guidelines in 1978° this specification was modified to language which prohibited “‘deliberate release into the environment of any organism containing recombinant DNA’; individual waivers could, however, be approved by the Director, NIH, following publication of proposals for public comment in the Federal Register and review by the NIH RAC and ap- proval by the local oversight committee, the Institutional Biosafety Committee (IBC). In the April 1982 version‘ of the guidelines, this language was modified to permit experiments involving release to the environment but NIH review and NIH and IBC approval before initiation are required. In these various versions of its guidelines, the NIH did not officially define what constitutes release into the en- vironment. In general, release was considered to be any experiment or procedure which occurred outside of a con- tained facility such as a laboratory or a fermentation plant in which equipment, practices, and procedures described in the NIH guidelines were employed. Eventually, beginning in 1983 NIH developed language which was to serve as guidance for certain testing involv- ing modified organisms outside of ‘‘contained’’ facilities. These documents describe the types of data required for evaluating experiments involving field testing of: (1) cer- tain modified plants‘, and (2) modified microorganisms.’ These documents do not specifically define ‘‘release.’’ As biotechnology products approached the point of testing in the environment, concerns were raised about the adequacy of the NIH system to oversee these products of the ‘‘new’’ biotechnology. These concerns arose for several reasons: e The NIH Guidelines only apply to those institutions which receive government funding. They do not apply to *Biological containment depends on characteristics the organisms possess which limit their ability to survive. Physical containment con- sists of a set of equipment, operating procedures and practices, and facili- ty design (buildings). The goal of containment is to ‘‘control’’ or ‘restrict’ dissemination of the organisms.