Astm Standards Development

Overview of Consensus Standard Development by E-48

The life cycle of an ASTM standard begins when a need is recognized and deemed appropriate for development by the E-48 technical subcommittee and executive subcommittee (1). Task groups are assigned by the subcommittee chair, and experts are assigned to develop a standard using proper format (6), which is then voted on by the subcommittee members.

• Subcommittee ballots require an affirmative vote of at least two-thirds of the votes cast by voting members, at least 60% of the voting members must return the letter ballots. If a negative vote is received with explanation of the reasons for the negative, then the subcommittee must resolve the negative by a meeting of the subcommittee or by another letter ballot. In a consensus standard, it is essential to properly resolve any negative ballot issues so that a full consensus is obtained.

• Main committee ballots are used to vote on the standard after completion of a subcommittee letter ballot. ASTM headquarters issues all letter ballots for the main committee. An affirmative vote of at least 90%

of the voting members is needed, at least 60% of the voting members must return the letter ballots. The task of resolving all negative votes not previously considered belongs to the original subcommittee. If substantive changes to the standard are required, then the standard is reballoted normally at the subcommittee level.

• Society review of the standard is conducted simultaneously with the main committee ballot through publication in the monthly ASTM magazine, Standardization News. Each member of the society can then vote on the standard. Negatives again must be fully addressed by the appropriate subcommittee that developed the standard.

• The Committee on Standards then reviews the balloting and approves publication ofthe standard in the Annual Book of ASTM Standards.

• Updating the approved standard can be achieved whenever a significant change is needed by using the entire balloting sequence. Every 4 years, each standard is reviewed and balloted for either revision, reapproval, or withdrawal.

The E-48 Committee also seeks comments on new draft standards from other reviewers, even if they are not members of ASTM, to be sure that the new standard receives full consensus from biotechnical interests. Often, E-48 is requested by other biotechnology associations to discuss biotech standards and activities at ASTM.

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