The structure of the workhorse organization to produce ASTM standards in biotechnology is shown in Figure 2.
In 1985, the ASTM Board of Directors approved establishing the E-48 Committee on Biotechnology to answer requests from industry and government and provide voluntary consensus standards that would meet the needs in this rapidly emerging new field. E-48 founding members developed new bylaws and organization structure to represent a balanced interest from producers, general interest groups, and consumers. Because E-48 develops standards for products, services, systems, and materials that are offered for sale, the committee is required to be classified and balanced; the number of voting members representing producers does not exceed the total membership in the remaining classifications of voting members (5). Currently, there are about 100 members of E-48 from international and domestic countries. Officers are elected by the E-48 membership, and those in key positions serve for 2 years.
The chairperson and two vice chairpersons direct and manage the activities of the E-48 administrative and technical subcommittees (Fig. 2). The Executive Subcommittee provides direction for the main committee, including longrange planning, symposium planning, and coordination of the technical and technical service subcommittees. The Main Committee meets semiannually to conduct business, review balloting, approve new members, and plan for the short- and long-range interests of developing standards for biotechnology. E-48 has sponsored several symposia (7) for biotechnology and has published papers through ASTM. Papers resulting from the symposia are subject to peer review and approval by the Committee on Publications before publication.
E-48 technical subcommittees have been organized to represent specific subjects within the scope of the E-48 charter. Each technical subcommittee is the primary resource to develop and approve ASTM standards for biotechnology as described in "Standards Development". Each technical subcommittee is normally subdivided into task groups that focus on specific standards development. The
task group is composed of ASTM, affiliated, and non-ASTM members who are knowledgeable about the subject matter. The numbers of task groups vary, depending on the subjects being considered for standards. Minutes of all formal meetings are published for distribution to ASTM members to communicate the status and to correlate the overall committee work. For information on the E-48 subcommittee standards developed by specific subcommittees, refer to "E-48 Standards Summary."
Liaison assignments to committee members are made to coordinate E-48 activities and interests with other ASTM committees or other standards organizations (8). For example, the charter of Committee E-47 on Biological Effects and Environmental Fate includes standards on (1) the effects of physical and chemical stress on aquatic and terrestrial plants and animals (including humans); and (2) the properties of materials that affect and determine their fate, distribution, and persistence when introduced into the environment. The Committee D-22 on Sampling and Analysis of Atmospheres covers biological aerosols, mainly from sampling and analytical aspects. These and other ASTM main committees may have overlapping scopes of interest with E-48, and close coordination is needed to properly develop a standard of common interest. Sometimes, a joint task group is formed, and representatives from various committees develop the common standard. This is necessary because the charter of E-48 covers interests that include characterization ofbiological species, bio-safety, processes using living organisms, environmental issues, biomass conversion, process validation, and terminology. Members of E-48 also serve as liaisons with other organizations, such as the American Society of Mechanical Engineers and professional, pharmaceutical, and drug manufacturing organizations.
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