1、Designation: E2565 09E2565 15Standard Guide forConsensus-based Process for an Occupational Safety andHealth Standard that Includes an Occupational ExposureGuideline1This standard is issued under the fixed designation E2565; the number immediately following the designation indicates the year oforigin
2、al adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide presents a framework for a stakeholder-focused consens
3、us-based decision-making process for occupationalsafety 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 act
4、ivities in which an occupational exposure guideline willbe included as one element of a comprehensive standard that addresses safety and health management strategies such ascommunication, monitoring and controls. It is not meant to be used to develop an OEG apart from the context of such managements
5、trategies. In cases where other occupational exposure limit (OEL) establishing bodies have developed OELs, those may bereviewed, assimilated, or adapted rather than recreated ab initio.1.3 This guide does not replace existing consensus-based, decision-making, or committee participation processes tha
6、t are usedto develop safety and health standards. It is intended to be used in conjunction with such processes to improve scientific andtechnical input and stakeholder involvement in occupational safety and health decision-making for such standards.1.4 LimitationsThis guide does not prescribe specif
7、ic methods for generating or evaluating scientific and technical data relatedto assessing a particular occupational safety and health issue. Occupational safety and health standards apply to a wide variety ofsubstances and occupational exposure circumstances. It is not possible to anticipate all sit
8、uations where an OEG may be usefulfor a standard. This guide will be helpful in promoting appropriate balance and input, but the consensus process must deal withreal world complexities that individual standards may involve.2. Terminology2.1 DefinitionsExcept as modified below this guide will utilize
9、 the definitions in Regulations Governing ASTM TechnicalCommittees.2.2 Definitions:2.2.1 stakeholder, nany individual, group, company, organization, government, or other entity, which may be directly affectedby or has a stake in the outcome of the specific consensus-based standard development proces
10、s.2.2.2 consensus-based occupational safety and health standard development (CBSD) process, na process to provideappropriate balance, scientific and technical information and stakeholder involvement for occupational safety and health standardswhich include or are proposed to include an occupational
11、exposure guideline.2.2.3 informed decision, nagreement reached by affected stakeholders, which is obtained by a process by which affectedstakeholders (1) are involved in a participative process that creates common understanding of the issues, concerns and prioritiesheld by all affected stakeholders;
12、 (2) assess, prioritize and select actions to improve the problem situation; and (3) achieveconsensus on specific initiatives related to the consensus based standard development process.2.2.4 occupational exposure guideline (OEG), na guideline used in an ASTM standard for limiting exposure to a chem
13、ical,physical, or biological agent to prevent unacceptable risk of harm to worker populations. OEGs may be established for mixtures.2.2.4.1 Discussion1 This guide is under the jurisdiction ofASTM Committee E34 on Occupational Health and Safety and is the direct responsibility of Subcommittee E34.01
14、on Terminology.Current edition approved Feb. 15, 2009June 1, 2015. Published March 2009June 2015. Originally approved in 2009. Last previous edition approved in 2009 as E2565 15.DOI: 10.1520/E2565-09.10.1520/E2565-15.This document is not an ASTM standard and is intended only to provide the user of a
15、n ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as publi
16、shed by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1An OEG may take one or more of several forms and should include considerations of the averaging time (for example, ceiling,short te
17、rm limits, full shift limits, etc.) and the target (individual workers, process or activity, population, position, etc.).2.2.5 occupational exposure limit (OEL), ngeneric term limiting exposure to a chemical, physical or biological agent.3. Summary of Guide3.1 The consensus-based occupational safety
18、 and health standard development (CBSD) process is established to identifyaffected stakeholders, facilitate relevant scientific and technical input, and provide appropriate balance with the goal of optimizingdecision-making with respect to occupational safety and health standards that include an OEG
19、.3.2 The CBSD process facilitates informed decision-making among affected committee and subcommittee members withconsensus developed through ASTMs review and ballot procedures. This guide promotes stakeholder involvement and technicalinput, but does not specify precise deliberation details or decisi
20、on criteria.4. Significance and Use4.1 This guide is designed to help identify and integrate affected stakeholder interests and to include relevant scientific andtechnical information when developing occupational safety and health standards that include or are proposed to include an OEG.4.2 This gui
21、de shall be used when updating an occupational safety and health standard containing an OEG.4.3 While use of the CBSD process is required for occupational safety and health standards that include an OEG, it may alsobe used to improve stakeholder involvement and technical input for other occupational
22、 safety and health standards.4.4 The CBSD process is intended:(1) to obtain representation on the committee or subcommittee from sectors that are substantially impacted by a specificstandard project; and(2) to obtain adequate input when the project requires review and analysis of information that is
23、 highly technical, veryspecialized or not widely available.5. Consensus-based Occupational Safety and Health Standard Development Process5.1 Identification of Affected Stakeholders and Determination of Committee Balance:5.1.1 At the beginning of a standards project, prior to its approval, membership
24、 in the relevant committee or subcommittee shallbe classified according to interest and reviewed for balance with respect to the issues and impacts related to the particular standardactivity.5.1.2 Affected stakeholders shall be identified for the particular standard activity.5.1.3 If all affected st
25、akeholder groups are not represented, under-represented or if representation is such that an informeddecision cannot be achieved, the committee or subcommittee shall actively recruit members from the unrepresented orunder-represented affected stakeholder groups and shall document such outreach effor
26、ts. Recruiting may include contactingpotential individuals, companies, organizations, trade groups, unions, or professional associations identified as representing theappropriate interest to notify them of the standards activity and invite them to become part of the standard development process.The
27、hallmarks of the consensus process are openness, shared understanding, willingness to achieve consensus, and rigorousdemocratic procedures.5.2 Scientific and Technical Input:5.2.1 At the beginning of an occupational safety and health standards project that includes an OEG, prior to the project appro
28、val,the committee or subcommittee shall identify scientific and technical issues and information relevant to the standards developmentprocess. A general request for submission of relevant scientific and technical information will be made to the Society.5.2.2 The committee or subcommittee shall evalu
29、ate its membership to determine if additional critical information, resourcesor expertise outside its membership is needed to complete development of an appropriate standard. If necessary, a general requestfor additional scientific and technical input and participation shall be made.5.2.3 Additional
30、 scientific and technical input may be obtained in one or more of the following ways:(1) experts may be recruited to the committee or subcommittee as members; or(2) experts may be invited to participate in committee or subcommittee activities as advisors or correspondents; or(3) information may be d
31、eveloped through independent meetings or scientific symposia where experts are invited to presentcurrent assessments of the scientific or technical issues of interest.5.2.3.1 The committee shall communicate its activities through liaison with scientific, professional, governmental andnon-governmenta
32、l organizations with potential interest in the standard project or in the OEG element of the standard project. Inputand concerns of such organizations shall be considered by the committee, including whether to proceed with the standard project.5.2.4 Outreach efforts and requests for additional scien
33、tific and technical information shall be documented.6. Process for Developing an Occupational Exposure Guideline (OEG)6.1 Initial DeterminationsE2565 1526.1.1 The standard developing committee shall determine if the safety and health standard needs an OEG because, among otherreasons, the standard wi
34、ll contain provisions, such as for monitoring or medical surveillance, which are triggered by an OEG.6.1.2 The committee shall review established OELs, including those from regulatory agencies, professional organizations,international standards and manufacturersrecommendations to determine whether a
35、n existing limit is appropriate for the purposesof the standard under development.6.2 Health Considerations6.2.1 When establishing a new OEG or endorsing an existing OEL, protection of worker health shall be the primaryconsideration.6.3 Application of OEG6.3.1 If an OEG is deemed appropriate for an
36、existing or new occupational health and safety standard, the committee shall definehow the OEG is to be applied. The following aspects may be considered:6.3.1.1 The route of exposure. For example, consider inhalation, dermal, ingestion, or a combination of these routes of exposure.6.3.1.2 Limitation
37、s of an OEG, recognizing that an OEG is generally not a fine line between safe and unsafe levels.6.3.1.3 The type of OEG that is to be recommended. For example, consider whether the OEG should be a time-weightedaverage, a ceiling limit, a short-term exposure limit, and/oror an exposure immediately d
38、angerous to life and health. health, orcombinations thereof. If more than one type of OEG is appropriate include all those that apply.6.3.1.4 If the occupational exposure contains multiple substances, consider the impact of mixed exposures.6.3.1.5 Time pattern of exposures and potential health effec
39、ts including adjustments for excursions and non-traditional shifts.6.3.1.6 Sensitive populations.6.3.1.7 Characteristics of exposure. For example, if inhalation is a route of exposure, consider aerosol size; if a physical hazardis considered frequency or wavelength may be important.6.3.1.8 Where the
40、 exposure is defined; for example where is the breathing zone when various types of personal protectiveequipment (PPE) are used.6.4 Measurement Considerations6.4.1 The technical feasibility method of measuring the contaminant or agent of interest shall be considered in the developmentof a standard t
41、hat includes an OEG. The limit of detection, the limit of quantification and the expected variation must be consideredas they relate to determining workplace compliance with the OEG.6.4.2 Analytical approaches can include alternative measurement techniques such as the use of a surrogate for a mixtur
42、e, theuse of direct-reading instruments, or other representative techniques.6.4.3 Practical considerations of the analytical method should consider the applicability of the method for performing source,area, and personal sampling. The cost of the analytical method should also be considered in specif
43、ying alternative measurementstrategies.6.4.4 The effect of variability in results between different sampling and analytical strategies should be considered.7. Feasibility7.1 While an OEG should be based primarily on health considerations, feasibility is an important consideration in thedevelopment o
44、f an overall usable standard. Feasibility is a key consideration of the standard as a whole, but not necessarily of theOEG.7.2 Technical and economic feasibility considerations may take several forms:7.2.1 In determining the form of an OEG, for example, when a surrogate would be appropriate in light
45、 of the reliability of theavailable methods of measurement at the exposure levels of interest.7.2.2 In determining the control measures to be employed in conforming with an OEG.7.2.3 In determining the level of an OEG in certain circumstances where the OEG generated by a purely health-basedassessmen
46、t would be impractical, for example, the OEG would be below the ambient exposure level.7.3 It shall be the responsibility of the committee or subcommittee writing the standard to determine how feasibilityconsiderations will be factored into the standard.E2565 1538. Keywords8.1 consensus based standa
47、rd development; occupational exposure guideline; occupational exposure limit; OEG; OEL; PEL;permissible exposure limit; stakeholderASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard
48、are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif no
49、t revised, either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohock
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