ASTM E2565-21

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Designation: E2565 − 20 E2565 − 21
Standard Guide for
Consensus-Based Process for an Occupational Safety and
Health Standard That Includes an Occupational Exposure
Guideline
This standard is issued under the fixed designation E2565; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope*
1.1 This guide presents a framework for a stakeholder-focused, consensus-based decision-making process for occupational safety
and health standard development activities that include adoption or development of occupational exposure guidelines (OEGs) as
a part of occupational health and safety standards.
1.2 This guide applies to safety and health standard development activities in which an occupational exposure guideline will be
included as one element of a comprehensive standard that addresses safety and health management strategies such as
communication, monitoring, and controls. It is not meant to be used to develop an OEG apart from the context of such management
strategies. In cases where other occupational exposure limit (OEL) establishing bodies have developed OELs, those may be
reviewed, assimilated, or adapted rather than recreated ab initio.
1.3 This guide does not replace existing consensus-based decision-making or committee participation processes that are used to
develop safety and health standards. It is intended to be used in conjunction with such processes to improve scientific and technical
input and stakeholder involvement in occupational safety and health decision-making for such standards.
1.4 Limitations—This guide does not prescribe specific methods for generating or evaluating scientific and technical data related
to assessing a particular occupational safety and health issue. Occupational safety and health standards apply to a wide variety of
substances and occupational exposure circumstances. It is not possible to anticipate all situations where an OEG may be useful
for a standard. This guide will be helpful in promoting appropriate balance and input, but the consensus process must deal with
real-world complexities that individual standards may involve.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
E1542 Terminology Relating to Occupational Health and Safety
This guide is under the jurisdiction of ASTM Committee E34 on Occupational Health and Safety and is the direct responsibility of Subcommittee E34.80 on Industrial
Heath.
Current edition approved Nov. 1, 2020April 1, 2021. Published November 2020April 2021. Originally approved in 2009. Last previous edition approved in 20152020 as
E2565 – 15.E2565 – 20. DOI: 10.1520/E2565-20.10.1520/E2565-21.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2565 − 21
3. Terminology
3.1 Definitions—For definitions of terms used in this standard, see Terminology E1542.
3.2 Definitions:
3.2.1 consensus-based occupational safety and health standard development (CBSD) process, n—a process to provide appropriate
balance, scientific and technical information, and stakeholder involvement for occupational safety and health standards which
include or are proposed to include an occupational exposure guideline.
3.2.1 informed decision, n—agreement reached by affected stakeholders, which is obtained by a process by which affected
stakeholders (1) are involved in a participative process that creates common understanding of the issues, concerns, and priorities
held by all affected stakeholders; (2) assess, prioritize, and select actions to improve the problem situation; and (3) achieve
consensus on specific initiatives related to the consensus-based standard development process.
3.2.2 occupational exposure guideline (OEG), n—a guideline used in an ASTM standard for limiting exposure to a chemical,
physical, or biological agent to prevent unacceptable risk of harm to worker populations. OEGs may be established for mixtures.
3.2.2.1 Discussion—
An OEG may take one or more of several forms and should include considerations of the averaging time (for example, ceiling,
short term limits, full shift limits, etc.) and the target (individual workers, process or activity, population, position, etc.).
3.2.3 occupational exposure limit (OEL), n—generic term limiting exposure to a chemical, physical, or biological agent.
3.2.4 stakeholder, stakeholder (interested party), n—any individual, group, company, organization, government, or other entity,
which may be directly affected by or has a stake in the outcome of the specific consensus-based standard development
process.person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity.
3.3 Abbreviations:
3.3.1 CBSD—consensus-based occupational safety and health standard development
4. Summary of Guide
4.1 The consensus-based occupational safety and health standard development (CBSD) process is established to identify affected
stakeholders, facilitate relevant scientific and technical input, and provide appropriate balance with the goal of optimizing
decision-making with respect to occupational safety and health standards that include an OEG.
4.2 The CBSD process facilitates informed decision-making among affected committee and subcommittee members with
consensus developed through ASTM’s review and ballot procedures. This guide promotes stakeholder involvement and technical
input, but does not specify precise deliberation details or decision criteria.
5. Significance and Use
5.1 This guide is designed to help identify and integrate affected stakeholder interests and to include relevant scientific and
technical information when developing occupational safety and health standards that include or are proposed to include an OEG.
5.2 This guide shall be used when updating an occupational safety and health standard containing an OEG.
5.3 While use of the CBSD process is required for occupational safety and health standards that include an OEG, it may also be
used to improve stakeholder involvement and technical input for other occupational safety and health standards.
5.4 The CBSD process is intended:
(1) To obtain representation on the committee or subcommittee from sectors that are substantially impacted by a specific
standard project; and
(2) To obtain adequate input when the project requires review and analysis of information that is highly technical, very
specialized, or not widely available.
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6. Consensus-Based Occupational Safety and Health Standard Development Process
6.1 Identification of Affected Stakeholders and Determination of Committee Balance:
6.1.1 At the beginning of a standards project, prior to its approval, membership in the relevant committee or subcommittee shall
be classified according to interest and reviewed for balance with respect to the issues and impacts related to the particular standard
activity.
6.1.2 Affected stakeholders shall be identified for the particular standard activity.
6.1.3 If all affected stakeholder groups are not represented, under-represented, or if representation is such that an informed
decision cannot be achieved, the committee or subcommittee shall actively recruit members from the unrepresented or
under-represented affected stakeholder groups and shall document such outreach effo
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