ASTM E2535-07
(Guide)Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings
SIGNIFICANCE AND USE
This Guide is intended for use by entities involved in the handling of UNP in occupational settings. The Guide covers handling principles and techniques that may be applied, as appropriate, to the variety of UNP materials and handling settings. These settings include research and development activities, material manufacturing, and material use and processing. The Guide may also be used by entities that receive materials or articles containing or comprising nanoscale particles fixed upon or within a matrix (i.e., bound nanoscale particles), but whose own processes or use may reasonably be expected to cause such particles to become unbound.
SCOPE
1.1 This Guide describes actions that could be taken by the user to minimize human exposures to unbound, engineered nanoscale particles (UNP) in research, manufacturing, laboratory and other occupational settings where UNP may reasonably be expected to be present. It is intended to provide guidance for controlling such exposures as a cautionary measure where neither relevant exposure standards nor definitive hazard and exposure information exist.
1.2 General Guidance - This Guide is applicable to occupational settings where UNP may reasonably be expected to be present. Operations across those settings will vary widely in the particular aspects relevant to nanoscale particle exposure control. UNP represent a vast variety of physical and chemical characteristics (e.g., morphology, mass, dimension, chemical composition, settling velocities, surface area, surface chemistry) and circumstances of use. Given the range of physical and chemical characteristics presented by the various UNP, the diversity of occupational settings and the uneven empirical knowledge of and experience with handling UNP materials, the purpose of this Guide is to offer general guidance on exposure minimization approaches for UNP based upon a consensus of viewpoints, but not to establish a standard practice nor to recommend a definite course of action to follow in all cases.
1.2.1 Accordingly, not all aspects of this Guide may be relevant or applicable to all circumstances of UNP handling. The user should apply reasonable judgment in applying this Guide including consideration of the characteristics of the particular UNP involved, the users engineering and other experience with the material, and the particular occupational settings where the user may apply this Guide. Users are encouraged to obtain the services of qualified professionals in applying this Guide.
1.2.2 Applicable Where Relevant Exposure Standards Do Not Exist - This Guide assumes that the user is aware of and in compliance with any authoritative occupational exposure standard applicable to the bulk form of the UNP. This Guide may be appropriate where such exposure standards do not exist, or where such standards exist, but were not developed with consideration of the nanoscale form of the material.
1.3 Applicable Where Robust Risk Information Does Not Exist - This Guide assumes the absence of scientifically sound risk assessment information relevant to the particular UNP involved. Where sound risk assessment information exists, or comes to exist, any exposure control measures should be designed based on that information, and not premised on this Guide. Such measures may be more or less stringent than those suggested by this Guide.
1.4 Materials within Scope - This Guide pertains to unbound engineered nanoscale particles or their respirable agglomerates or aggregates thereof. Relevant nanoscale particle types include, for example, intentionally produced fullerenes, nanotubes, nanowires, nanoropes, nanoribbons, quantum dots, nanoscale metal oxides, and other engineered nanoscale particles. Respirable particles are those having an aerodynamic equivalent diameter (AED) less than or equal to 10 m (10 000 nm) or those particles small enough to be collected with a respirable sampler (12, 34, 36). The AED describes the beha...
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Designation: E2535 − 07
StandardGuide for
Handling Unbound Engineered Nanoscale Particles in
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Occupational Settings
This standard is issued under the fixed designation E2535; 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.
INTRODUCTION
Nanometer-scale particles are encountered in nature and in industry in a variety of forms and
materials. Engineered nanoscale particles as a class comprise a range of materials differing in shape,
size, and chemical composition, and represent a broad range of physical and chemical properties.
Workers within some nanotechnology-related industries and operations have the potential to be
exposed to these engineered nanoscale particles at levels exceeding ambient nanoscale particle
concentrations through inhalation, dermal contact and ingestion when not contained on or within a
matrix (unbound). Occupational health risks associated with manufacturing, processing and handling
unbound nanoscale particles, agglomerates or aggregates of nanoscale particles are not yet clearly
understood.Dominantexposureroutes,potentialexposurelevelsandanymaterialhazardareexpected
to vary widely among particular nanoscale particle materials and handling contexts. Additional
research is needed to understand the impact of these exposures on employee health and how best to
devise appropriate exposure monitoring and control strategies. Until clearer understandings emerge,
the limited evidence available suggests caution when potential exposures to unbound engineered
nanoscale particles (UNP) may occur.
1. Scope knowledgeofandexperiencewithhandlingUNPmaterials,the
purpose of this Guide is to offer general guidance on exposure
1.1 This Guide describes actions that could be taken by the
minimization approaches for UNP based upon a consensus of
user to minimize human exposures to unbound, engineered
viewpoints, but not to establish a standard practice nor to
nanoscale particles (UNP) in research, manufacturing, labora-
recommend a definite course of action to follow in all cases.
tory and other occupational settings where UNP may reason-
1.2.1 Accordingly, not all aspects of this Guide may be
ably be expected to be present. It is intended to provide
relevant or applicable to all circumstances of UNP handling.
guidance for controlling such exposures as a cautionary mea-
The user should apply reasonable judgment in applying this
sure where neither relevant exposure standards nor definitive
Guide including consideration of the characteristics of the
hazard and exposure information exist.
particular UNP involved, the user’s engineering and other
1.2 General Guidance—This Guide is applicable to occu-
experience with the material, and the particular occupational
pational settings where UNPmay reasonably be expected to be
settings where the user may apply this Guide. Users are
present. Operations across those settings will vary widely in
encouraged to obtain the services of qualified professionals in
the particular aspects relevant to nanoscale particle exposure
applying this Guide.
control. UNPrepresent a vast variety of physical and chemical
1.2.2 Applicable Where Relevant Exposure Standards Do
characteristics (e.g., morphology, mass, dimension, chemical
Not Exist—This Guide assumes that the user is aware of and in
composition, settling velocities, surface area, surface chemis-
compliance with any authoritative occupational exposure stan-
try) and circumstances of use. Given the range of physical and
dard applicable to the bulk form of the UNP. This Guide may
chemical characteristics presented by the various UNP, the
be appropriate where such exposure standards do not exist, or
diversity of occupational settings and the uneven empirical
where such standards exist, but were not developed with
consideration of the nanoscale form of the material.
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This guide is under the jurisdiction of ASTM Committee E56 on Nanotech-
1.3 Applicable Where Robust Risk Information Does Not
nology and is the direct responsibility of Subcommittee E56.03 on Environment,
Exist—This Guide assumes the absence of scientifically sound
Health, and Safety.
risk assessment information relevant to the particular UNP
Current edition approved Sept. 15, 2007. Published October 2007. DOI:
10.1520/E2535-07. involved. Where sound risk assessment information exists, or
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2535 − 07
comes to exist, any exposure control measures should be 1.7 Not a Standard of Care—This ASTM stan
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