Introduction

As the biotechnology products and processes industry has grown during the past several decades, so has the realization grown that more standard test methods are needed to keep pace with regulatory requirements to assure the public that these products and processes are safe and ef fective methods of producing pure products. In 1996, the federal government passed a law directing federal agencies to participate in and use technical standards developed by voluntary consensus standards organizations, with few exceptions, to carry out policy objectives and activities. The American Society for Testing and Materials (ASTM) was specifically mentioned as an example of a voluntary consensus standards organization.

The ASTM E-48 Committee for Biotechnology was organized in 1985. This was in response to urging from the biotechnology community to lead the development of voluntary consensus standards in biosafety, characterization and identification of biotech organisms, preservation and storage, bioprocess controls and processing equipment, environmental issues, process validation, equipment qualification, and terminology. Biomass conversion standards responsibility was transferred to E-48 in 1987. Although many of these topics have analytical procedures currently in use by individual companies or trade organizations, there is a well-known need to standardize these procedures for fully acceptable application in industry and governmental regulatory organizations.

By 1997, the E-48 committee had published and is still responsible for more than 30 standards. More standards, based on the ASTM structured manner using technically qualified volunteers from international resources, are currently being developed.

This article explains the characteristics of voluntary consensus standards, how ASTM develops these standards, what standards are currently available, and which ASTM E-48 subcommittees are responsible for these and future standards development.

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