ASTM E2535-07(2018)
(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
5.1 This guide is intended for use by entities involved in the handling of UNP in occupational settings. This 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. This guide may also be used by entities that receive materials or articles containing or comprising nanoscale particles fixed upon or within a matrix (that is, 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 (for example, 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 user’s 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 µm (10 000 nm) or those particles small enough to be collected with a respirable sampler (1-3).2 The AED desc...
General Information
Relations
Standards Content (Sample)
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.
Designation: E2535 − 07 (Reapproved 2018)
Standard Guide for
Handling Unbound Engineered Nanoscale Particles in
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
Nanometre-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 empirical knowledge of and experience with handling UNP
materials, the purpose of this guide is to offer general guidance
1.1 This guide describes actions that could be taken by the
on exposure minimization approaches for UNP based upon a
user to minimize human exposures to unbound, engineered
consensus of viewpoints, but not to establish a standard
nanoscale particles (UNP) in research, manufacturing, labora-
practice nor to recommend a definite course of action to follow
tory and other occupational settings where UNP may reason-
in all cases.
ably be expected to be present. It is intended to provide
1.2.1 Accordingly, not all aspects of this guide may be
guidance for controlling such exposures as a cautionary mea-
relevant or applicable to all circumstances of UNP handling.
sure where neither relevant exposure standards nor definitive
The user should apply reasonable judgment in applying this
hazard and exposure information exist.
guide including consideration of the characteristics of the
1.2 General Guidance—This guide is applicable to occupa-
particular UNP involved, the user’s engineering and other
tional settings where UNP may reasonably be expected to be
experience with the material, and the particular occupational
present. Operations across those settings will vary widely in
settings where the user may apply this guide. Users are
the particular aspects relevant to nanoscale particle exposure
encouraged to obtain the services of qualified professionals in
control. UNPrepresent a vast variety of physical and chemical
applying this guide.
characteristics (for example, morphology, mass, dimension,
1.2.2 Applicable Where Relevant Exposure Standards Do
chemical composition, settling velocities, surface area, surface
Not Exist—This guide assumes that the user is aware of and in
chemistry) and circumstances of use. Given the range of
compliance with any authoritative occupational exposure stan-
physical and chemical characteristics presented by the various
dardapplicabletothebulkformoftheUNP.Thisguidemaybe
UNP, the diversity of occupational settings and the uneven
appropriate where such exposure standards do not exist, or
where such standards exist, but were not developed with
This guide is under the jurisdiction of ASTM Committee E56 on Nanotech-
consideration of the nanoscale form of the material.
nology and is the direct responsibility of Subcommittee E56.03 on Environment,
Health, and Safety.
1.3 Applicable Where Robust Risk Information Does Not
Current edition approved Oct. 1, 2018. Published October 2018. Originally
Exist—This guide assumes the absence of scientifically sound
approved in 2007. Last previous edition approved in 2013 as E2535 – 07 (2013).
DOI: 10.1520/E2535-07R18. risk assessment information relevant to the particular UNP
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2535 − 07 (2018)
involved. Where sound risk assessment information exists, or 1.7 Not a Standard of Care—This guide does not necessar-
comes to exist, any exposure control measures should be ily represent the standard of care by which the adequacy of a
designed based on that information, and not premised on this set of exposure control measures should be judged; nor should
guide. Such measures may be more or less stringent than those this document be used without consideration of the particular
suggested by this guide. materials and occupational circumstances to which it may be
applied. The word “standard” in the title means only that the
1.4 Materials Within Scope—This guide pertains to un-
document has been approved through the ASTM consensus
bound engineered nanoscale particles or their respirable ag-
process.
glomerates or aggregates thereof. Relevant nanoscale particle
types include, for example, intentionally produced fullerenes, 1.8 The values stated in SI units are to be regarded as
nanotubes, nanowires, nanoropes, nanoribbons, quantum dots, standard. No other units of measurement are included in this
nanoscale metal oxides, and other engineered nanoscale par- standard.
ticles. Respirable particles are those having an aerodynamic
1.9 This standard does not purport to address all of the
equivalent diameter (AED) less than or equal to 10 µm (10 000
safety concerns, if any, associated with its use. It is the
nm) or those particles small enough to be collected with a
responsibility of the user of this standard to establish appro-
respirable sampler (1-3). The AED describes the behavior of
priate safety, health, and environmental practices and deter-
an airborne particle and is dependent upon the particle density,
mine the applicability of regulatory limitations prior to use.
shape,andsize—forinstance,aparticlewithasphericalshape,
1.10 This international standard was developed in accor-
smooth surface, density of 1.0 g/cc and a physical diameter of
dance with internationally recognized principles on standard-
4 µm would have an AED of 4 µm, whereas a particle with a
ization established in the Decision on Principles for the
spherical shape, smooth surface, density of 11.35 g/cc and a
Development of International Standards, Guides and Recom-
physical diameter of 4 µm would have an AED of 14 µm and
mendations issued by the World Trade Organization Technical
would therefore be of a nonrespirable size. Respirable fibers
Barriers to Trade (TBT) Committee.
are those having physical diameters less than or equal to 3 µm
(3000 nm) or those fibers small enough to be collected with a
2. Referenced Documents
thoracic sampler (4, 5).
2.1 ASTM Standards:
1.5 Materials Beyond Scope:
E2456 Terminology Relating to Nanotechnology
1.5.1 UNP may be present in various forms, such as
F1461 Practice for Chemical Protective Clothing Program
powders or suspensions, or as agglomerates and aggregates of
primary particles, or as particles dispersed in a matrix. This 3. Terminology
guide does not pertain to UNPincapable, as a practical matter,
3.1 Definitions—Refer to Terminology E2456 for defini-
from becoming airborne or be expected to generate or release
tions of terms used within this guide.
UNP in occupational settings under the particular circum-
3.2 Definitions of Terms Specific to This Standard:
stancesofuse(forexample,UNPsdispersedorotherwisefixed
3.2.1 aerodynamic equivalent diameter (AED), n—the di-
within a solid, strongly bonded to a substrate or contained
ameter of a smooth, unit density [ρ = 1 gram per cubic
within a liquid matrix such as aggregated primary crystals of o
centimetre (g/cm )] sphere that has the same terminal settling
pigments in paints). This guide does not pertain to aggregates
velocity as the actual particle (6).
or agglomerates of UNP that are not of a respirable size.
1.5.2 This guide does not pertain to materials that present 3.2.2 agglomerate, n—in nanotechnology, a group of par-
nanoscale surface features, but do not contain UNPs (for
ticlesheldtogetherbyrelativelyweakforces(forexample,van
example,nanoscalelithographyproducts,nanoelectronicstruc- derWaalsorcapillary.)andwhichmaybreakapartintosmaller
tures or materials comprised of nanoscale layers).
particles upon processing.
1.5.3 This guide does not pertain to UNPs which exist in
3.2.3 aggregate, n—in nanotechnology, a discrete group of
naturewhichmaybepresentinnormalambientatmospheresor
particles in which the various individual components are not
are unintentionally produced by human activities, such as by
easilybrokenapart,suchasinthecaseofprimaryparticlesthat
combustion processes. Nor does it pertain to materials that
are strongly bonded together (for example, fused, sintered, or
have established exposure control programs (for example, safe
metallically bonded particles).
handling protocols for nanoscale biological agents) or pub-
3.2.4 control principle, n—the principle establishes in this
lished exposure limits such as occupational exposure limits for
guide that, as a cautionary measure, occupational exposures to
welding fumes. See Appendix X1.
unbound, engineered nanoscale particles (UNP) should be
1.6 Handling Considerations Beyond Scope—The use of
minimizedtolevelsthatareaslowasisreasonablypracticable.
this guide is limited to the scope set forth in this section. This
3.2.5 nanoscale, adj—having one or more dimensions on
guide generally does not address actions related to potential
the order of 1 to 100 nanometres.
environmental exposures, nor to exposures potentially arising
at disposal or other end-uses.
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
The boldface numbers in parentheses refer to the list of references at the end of Standards volume information, refer to the standard’s Document Summary page on
this standard. the ASTM website.
E2535 − 07 (2018)
3.2.6 particle, n—in nanotechnology, a small object that 5. Significance and Use
behaves as a whole unit in terms of transport and properties.
5.1 This guide is intended for use by entities involved in the
3.2.7 program, n—a management policy to minimize occu-
handling of UNP in occupational settings. This guide covers
pational UNP exposures together with the procedures and
handling principles and techniques that may be applied, as
actions to meet that objective.
appropriate, to the variety of UNP materials and handling
settings. These settings include research and development
3.2.8 respirable, adj—airborne particles which are small
activities, material manufacturing, and material use and pro-
enough to enter the alveolar (gas-exchange) region of the lung.
cessing. This guide may also be used by entities that receive
3.2.9 inhalable, adj—airborne particles which are small
materials or articles containing or comprising nanoscale par-
enoughtoentertheheadairwaysthroughthenoseormouth,or
ticles fixed upon or within a matrix (that is, bound nanoscale
both, during inhalation.
particles), but whose own processes or use may reasonably be
3.2.10 should, aux., v—as used in this guide, indicates that
expected to cause such particles to become unbound.
a provision is not mandatory but is recommended as a good
practice.
6. Establishing a Program to Implement the Control
3.2.11 ultrafine particle, n—aparticlesmallerthanabout0.1 Principle
micrometre (100 nanometres) in diameter.
6.1 Process for Establishing Program—To attain the inte-
3.2.12 unbound, adj—with reference to engineered na-
grated effort needed to minimize UNP exposures consistent
noscale particles, those nanoscale particles that are not con-
with the control principle, the user should develop a program
tained within a matrix under normal temperature and pressure
that addresses the efforts in all management, planning and
conditions that would reasonably be expected to prevent the
operational phases of the enterprise to be taken to achieve that
particlesfrombeingseparatelymobileandapotentialsourceof
objective.The principal topics of this guide outline an iterative
exposure. An engineered primary nanoscale particle dispersed
processtypicalofmanyoccupationalsafetyregimestheuserof
and fixed within a polymer matrix, incapable as a practical
this guide may adopt for the initial establishment and imple-
matter of becoming airborne, would be “bound,” while such a
mentation of an effective program to minimize occupational
particle suspended as an aerosol would be “unbound.”
UNP exposures.
3.3 Acronyms:
6.2 Management Commitment—A formal, written manage-
3.3.1 HEPA—high efficiency particulate air
ment policy should be established committing to minimizing
potential occupational UNPexposures to levels that are as low
3.3.2 MSDS—material safety data sheet(s)
as is reasonably practicable. The policy and commitment
3.3.3 PPE—personal protective equipment
should be regularly communicated throughout the organization
3.3.4 UNP—unbound engineered nanoscale particles
and reflected in (a) written administrative procedures, instruc-
tions and training materials for operations and contingencies
4. Summary of Guide
potentially involving occupational UNP exposures, (b) facili-
ties design, and (c) instructions to designers, vendors and user
4.1 This guide presents the elements of an UNP handling
personnel specifying or reviewing facility design, systems,
and exposure minimization program including considerations
operations or equipment.
and guidance, based on a consensus of viewpoints, for estab-
lishing such a program. The six principal elements are: (a)
6.3 Organization of Personnel and Responsibilities—
establishing management commitment to the control principle;
Responsibility and authority for implementing a minimization
(b) identifying and communicating potential hazards; (c) as-
program consistent
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.