1、Designation: E 2565 09Standard Guide forConsensus-based Process for an Occupational Safety andHealth Standard that Includes an Occupational ExposureGuideline1This standard is issued under the fixed designation E 2565; the number immediately following the designation indicates the year oforiginal ado
2、ption 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 consensus-bas
3、ed decision-making process for occupa-tional safety and health standard development activities thatinclude adoption or development of occupational exposureguidelines (OEGs) as a part of Occupational Health and Safetystandards.1.2 This guide applies to safety and health standard devel-opment activiti
4、es in which an occupational exposure guidelinewill be included as one element of a comprehensive standardthat addresses safety and health management strategies such ascommunication, monitoring and controls. It is not meant to beused to develop an OEG apart from the context of suchmanagement strategi
5、es. In cases where other occupationalexposure limit (OEL) establishing bodies have developedOELs, those may be reviewed, assimilated, or adapted ratherthan recreated ab initio.1.3 This guide does not replace existing consensus-based,decision-making, or committee participation processes that areused
6、to develop safety and health standards. It is intended to beused in conjunction with such processes to improve scientificand technical input and stakeholder involvement in occupa-tional safety and health decision-making for such standards.1.4 LimitationsThis guide does not prescribe specificmethods
7、for generating or evaluating scientific and technicaldata related to assessing a particular occupational safety andhealth issue. Occupational safety and health standards apply toa wide variety of substances and occupational exposure cir-cumstances. It is not possible to anticipate all situations whe
8、rean OEG may be useful for a standard. This guide will behelpful in promoting appropriate balance and input, but theconsensus process must deal with real world complexities thatindividual standards may involve.2. Terminology2.1 DefinitionsExcept as modified below this guide willutilize the definitio
9、ns in Regulations Governing ASTM Techni-cal Committees.2.2 Definitions:2.2.1 stakeholder, nany individual, group, company, or-ganization, government, or other entity, which may be directlyaffected by or has a stake in the outcome of the specificconsensus-based standard development process.2.2.2 cons
10、ensus-based occupational safety and health stan-dard development (CBSD) process, na process to provideappropriate balance, scientific and technical information andstakeholder involvement for occupational safety and healthstandards which include or are proposed to include an occu-pational exposure gu
11、ideline.2.2.3 informed decision, nagreement reached by affectedstakeholders, which is obtained by a process by which affectedstakeholders (1) are involved in a participative process thatcreates common understanding of the issues, concerns andpriorities held by all affected stakeholders; (2) assess,
12、prioritizeand select actions to improve the problem situation; and (3)achieve consensus on specific initiatives related to the consen-sus based standard development process.2.2.4 occupational exposure guideline (OEG), na guide-line used in an ASTM standard for limiting exposure to achemical, physica
13、l, or biological agent to prevent unacceptablerisk of harm to worker populations. OEGs may be establishedfor mixtures.2.2.4.1 DiscussionAn OEG may take one or more ofseveral forms and should include considerations of the aver-aging time (for example, ceiling, short term limits, full shiftlimits, etc
14、.) and the target (individual workers, process oractivity, population, position, etc.).1This guide is under the jurisdiction of ASTM Committee E34 on OccupationalHealth and Safety and is the direct responsibility of Subcommittee E34.01 onTerminology.Current edition approved Feb. 15, 2009. Published
15、March 2009.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.2.2.5 occupational exposure limit (OEL), ngeneric termlimiting exposure to a chemical, physical or biological agent.3. Summary of Guide3.1 The consensus-based occupational sa
16、fety and healthstandard development (CBSD) process is established to iden-tify affected stakeholders, facilitate relevant scientific andtechnical input, and provide appropriate balance with the goalof optimizing decision-making with respect to occupationalsafety and health standards that include an
17、OEG.3.2 The CBSD process facilitates informed decision-makingamong affected committee and subcommittee members withconsensus developed through ASTMs review and ballot pro-cedures. This guide promotes stakeholder involvement andtechnical input, but does not specify precise deliberation detailsor deci
18、sion criteria.4. Significance and Use4.1 This guide is designed to help identify and integrateaffected stakeholder interests and to include relevant scientificand technical information when developing occupational safetyand health standards that include or are proposed to include anOEG.4.2 This guid
19、e shall be used when updating an occupationalsafety and health standard containing an OEG.4.3 While use of the CBSD process is required for occupa-tional safety and health standards that include an OEG, it mayalso be used to improve stakeholder involvement and technicalinput for other occupational s
20、afety and health standards.4.4 The CBSD process is intended:(1) to obtain representation on the committee or subcom-mittee from sectors that are substantially impacted by a specificstandard project; and(2) to obtain adequate input when the project requiresreview and analysis of information that is h
21、ighly technical,very specialized or not widely available.5. Consensus-based Occupational Safety and HealthStandard Development Process5.1 Identification of Affected Stakeholders and Determina-tion of Committee Balance:5.1.1 At the beginning of a standards project, prior to itsapproval, membership in
22、 the relevant committee or subcom-mittee shall be classified according to interest and reviewed forbalance with respect to the issues and impacts related to theparticular standard activity.5.1.2 Affected stakeholders shall be identified for the par-ticular standard activity.5.1.3 If all affected sta
23、keholder groups are not represented,under-represented or if representation is such that an informeddecision cannot be achieved, the committee or subcommitteeshall actively recruit members from the unrepresented orunder-represented affected stakeholder groups and shall docu-ment such outreach efforts
24、. Recruiting may include contactingpotential individuals, companies, organizations, trade groups,unions, or professional associations identified as representingthe appropriate interest to notify them of the standards activityand invite them to become part of the standard developmentprocess. The hall
25、marks of the consensus process are openness,shared understanding, willingness to achieve consensus, andrigorous democratic procedures.5.2 Scientific and Technical Input:5.2.1 At the beginning of an occupational safety and healthstandards project that includes an OEG, prior to the projectapproval, th
26、e committee or subcommittee shall identify scien-tific and technical issues and information relevant to thestandards development process. A general request for submis-sion of relevant scientific and technical information will bemade to the Society.5.2.2 The committee or subcommittee shall evaluate i
27、tsmembership to determine if additional critical information,resources or expertise outside its membership is needed tocomplete development of an appropriate standard. If necessary,a general request for additional scientific and technical inputand participation shall be made.5.2.3 Additional scienti
28、fic and technical input may be ob-tained in one or more of the following ways:(1) experts may be recruited to the committee or subcom-mittee as members; or(2) experts may be invited to participate in committee orsubcommittee activities as advisors or correspondents; or(3) information may be develope
29、d through independentmeetings or scientific symposia where experts are invited topresent current assessments of the scientific or technical issuesof interest.5.2.3.1 The committee shall communicate its activitiesthrough liaison with scientific, professional, governmental andnon-governmental organiza
30、tions with potential interest in thestandard project or in the OEG element of the standard project.Input and concerns of such organizations shall be consideredby the committee, including whether to proceed with thestandard project.5.2.4 Outreach efforts and requests for additional scientificand tech
31、nical information shall be documented.6. Process for Developing an Occupational ExposureGuideline (OEG)6.1 Initial Determinations6.1.1 The standard developing committee shall determine ifthe safety and health standard needs an OEG because, amongother reasons, the standard will contain provisions, su
32、ch as formonitoring or medical surveillance, which are triggered by anOEG.6.1.2 The committee shall review established OELs, includ-ing those from regulatory agencies, professional organizations,international standards and manufacturers recommendationsto determine whether an existing limit is approp
33、riate for thepurposes of the standard under development.6.2 Health Considerations6.2.1 When establishing a new OEG or endorsing an exist-ing OEL, protection of worker health shall be the primaryconsideration.6.3 Application of OEG6.3.1 If an OEG is deemed appropriate for an existing ornew occupation
34、al health and safety standard, the committeeshall define how the OEG is to be applied. The followingaspects may be considered:E25650926.3.1.1 The route of exposure. For example, consider inha-lation, dermal, ingestion, or a combination of these routes ofexposure.6.3.1.2 Limitations of an OEG, recogn
35、izing that an OEG isgenerally not a fine line between safe and unsafe levels.6.3.1.3 The type of OEG that is to be recommended. Forexample, consider whether the OEG should be a time-weightedaverage, a ceiling limit, a short-term exposure limit, and/or anexposure immediately dangerous to life and hea
36、lth. If morethan one type of OEG is appropriate include all those thatapply.6.3.1.4 If the occupational exposure contains multiple sub-stances, consider the impact of mixed exposures.6.3.1.5 Time pattern of exposures and potential healtheffects including adjustments for excursions and non-traditiona
37、l shifts.6.3.1.6 Sensitive populations.6.3.1.7 Characteristics of exposure. For example, if inhala-tion is a route of exposure, consider aerosol size; if a physicalhazard is considered frequency or wavelength may be impor-tant.6.3.1.8 Where the exposure is defined; for example where isthe breathing
38、zone when various types of personal protectiveequipment (PPE) are used.6.4 Measurement Considerations6.4.1 The technical feasibility of measuring the contaminantor agent of interest shall be considered in the development ofa standard that includes an OEG. The limit of detection, thelimit of quantifi
39、cation and the expected variation must beconsidered as they relate to determining workplace compliancewith the OEG.6.4.2 Analytical approaches can include alternative mea-surement techniques such as the use of a surrogate for amixture, the use of direct-reading instruments, or other repre-sentative
40、techniques.6.4.3 Practical considerations of the analytical methodshould consider the applicability of the method for performingsource, area, and personal sampling. The cost of the analyticalmethod should also be considered in specifying alternativemeasurement strategies.6.4.4 The effect of variabil
41、ity in results between differentsampling and analytical strategies should be considered.7. Feasibility7.1 While an OEG should be based primarily on healthconsiderations, feasibility is an important consideration in thedevelopment of an overall usable standard. Feasibility is a keyconsideration of th
42、e standard as a whole, but not necessarily ofthe OEG.7.2 Technical and economic feasibility considerations maytake several forms:7.2.1 In determining the form of an OEG, for example,when a surrogate would be appropriate in light of the reliabilityof the available methods of measurement at the exposu
43、re levelsof interest.7.2.2 In determining the control measures to be employed inconforming with an OEG.7.2.3 In determining the level of an OEG in certain circum-stances where the OEG generated by a purely health-basedassessment would be impractical, for example, the OEG wouldbe below the ambient ex
44、posure level.7.3 It shall be the responsibility of the committee orsubcommittee writing the standard to determine how feasibilityconsiderations will be factored into the standard.8. Keywords8.1 consensus based standard development; occupationalexposure guideline; occupational exposure limit; OEG; OE
45、L;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 are expressly advised that determination of the validity of any such patent rights, a
46、nd 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 not revised, either reapproved or withdrawn. Your comments are invited either for revis
47、ion 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 s
48、houldmake 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 Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).E2565093
