ASTM D4236-94
(Practice)Standard Practice for Labeling Art Materials for Chronic Health Hazards
Standard Practice for Labeling Art Materials for Chronic Health Hazards
SCOPE
1.1 This practice describes a procedure for developing precautionary labels for art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This practice concerns those chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see 2.1.11) has the potential to produce a chronic adverse health effect(s).
1.2 This practice applies exclusively to art materials packaged in sizes intended for individual users of any age or those participating in a small group.
1.3 Labeling determinations shall consider reasonable forseeable use or misuse. The responsibility for precautionary labeling rests with the producer or repackager who markets the materials for art or craft use.
1.4 This practice does not specify test methods for determining whether a substance or product presents chronic health hazards.
1.5 This practice does not apply to products appropriately labeled for known chronic health hazards in accordance with chemical substance labeling standards and practices, such as another national consensus standard, existing labeling statutes, regulations, or guidelines.
1.6 Since knowledge about chronic health hazards is incomplete and warnings cannot cover all uses of any product, it is not possible for precautionary labeling to ensure completely safe use of an art product.
1.7 Manufacturers or repackagers may wish to determine individually or collectively precautionary labeling for art materials in accordance with this practice. Compliance may be certified by a certifying organization. Guidelines for a certifying organization are given in Appendix X1.
1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation: D 4236 – 94
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Practice for
Labeling Art Materials for Chronic Health Hazards
This standard is issued under the fixed designation D 4236; 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 (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Uninformed or careless use of some art material products can give rise to health hazards, either
acute or chronic, or both. Specific and readily available warnings are needed to help protect users of
any age. One way to disseminate such information is to provide appropriate precautionary labeling on
art material products.
Labeling for acute health hazards, including those associated with art materials, is being addressed
by such requirements as the U.S. Consumer Product Safety Act (CPSC) , the Federal Hazardous
Substances Act, and the like. There are presently no specific national standards for labeling art
materials with respect to chronic health hazards.
This practice is intended to provide a standard for developing precautionary labels concerning
chronic health hazards related to the use of art materials. It is further intended to have the adaptability
necessary to keep labels current with existing scientific and medical knowledge, as well as in
conformity with other precautionary labeling requirements, both acute and chronic, thereby avoiding
unnecessary confusion by users with respect to other precautionary labeling.
1. Scope 1.5 This practice does not apply to products appropriately
labeled for known chronic health hazards in accordance with
1.1 This practice describes a procedure for developing
chemical substance labeling standards and practices, such as
precautionary labels for art materials and provides hazard and
another national consensus standard, existing labeling statutes,
precautionary statements based upon knowledge that exists in
regulations, or guidelines.
the scientific and medical communities. This prac-
1.6 Since knowledge about chronic health hazards is incom-
tice concerns those chronic health hazards known to be
plete and warnings cannot cover all uses of any product, it is
associated with a product or product component(s), when the
not possible for precautionary labeling to ensure completely
component(s) is present in a physical form, volume, or
safe use of an art product.
concentration that in the opinion of a toxicologist (see 2.1.11)
1.7 Manufacturers or repackagers may wish to determine
has the potential to produce a chronic adverse health effect(s).
individually or collectively precautionary labeling for art
1.2 This practice applies exclusively to art materials pack-
materials in accordance with this practice. Compliance may be
aged in sizes intended for individual users of any age or those
certified by a certifying organization. Guidelines for a certify-
participating in a small group.
ing organization are given in Appendix X1.
1.3 Labeling determinations shall consider reasonable fors-
1.8 This standard does not purport to address all of the
eeable use or misuse. The responsibility for precautionary
safety concerns, if any, associated with its use. It is the
labeling rests with the producer or repackager who markets the
responsibility of the user of this standard to establish appro-
materials for art or craft use.
priate safety and health practices and determine the applica-
1.4 This practice does not specify test methods for deter-
bility of regulatory limitations prior to use.
mining whether a substance or product presents chronic health
hazards.
2. Terminology
2.1 Definitions of Terms Specific to This Standard:
This practice is under the jurisdiction of ASTM Committee D-1 on Paint and 2.1.1 analytical laboratory—a laboratory having personnel
Related Coatings, Materials, and Applications and is the direct responsibility of
and apparatus capable of performing quantitative or qualitative
Subcommittee D01.57 on Artist Paints and Related Materials.
analyses of art materials, which may yield information that is
Current edition approved March 15, 1994. Published May 1994. Originally
used by a toxicologist for evaluation of potentially hazardous
published as D 4236 – 83. Last previous edition D 4236 – 92.
ASTM Practice D 4236 has been codified into U.S. law as part of the Federal
materials.
Hazardous Substances Act, 15 USC S1277. User of this standard should be familiar
2.1.2 art material or art material product—any raw or
with the law and its regulations. Under this law and its regulations (16 CRF 1500),
processed material, or manufactured product, marketed or
manufacturers must submit to the CPSC (Washington DC 20207) written criteria
used by the toxicologist to recommend labeling. represented by the producer or repackager as intended for and
D 4236
suitable for users as defined herein. 4 of this practice, shall adopt precautionary labeling in accor-
2.1.3 bioavailability—the extent that a substance can be dance with Section 5 of this practice and based upon generally
absorbed in a biologically active form. accepted, well-established evidence that a component sub-
2.1.4 chronic adverse health effect(s)—a persistent toxic stance(s) is known to cause chronic adverse health effects.
effect(s) that develops over time from a single, prolonged, or 3.3 To conform to this practice, labeling shall be parallel to,
repeated exposure to a substance. This effect may result from conform to, and minimally include any labeling practices
exposure(s) to a substance that can, in humans, cause sterility, prescribed by U.S. federal and state statutes or regulations and
birth defects, harm to a developing fetus or to a nursing infant, shall not diminish the effect of required acute toxicity warn-
cancer, allergenic sensitization, damage to the nervous system, ings.
or a persistent adverse effect to any other organ system. 3.4 To conform to this practice, the producer or repackager
2.1.5 chronic health hazard(s) (hereafter referred to as shall supply a poison exposure management information
“chronic hazard”)—a health risk to humans, resultant from source the generic formulation information required for dis-
exposure to a substance that may cause a chronic adverse semination to poison control centers or provide a 24-h cost-free
health effect. telephone number to poison control centers.
2.1.6 label—a display of written, printed, or graphic matter 3.5 To conform to this practice, the producer or repackager
upon the immediate container of any art material product. shall have a toxicologist review as necessary, but at least every
When the product is unpackaged, or is not packaged in an 5 years, art material product formulation(s) and associated
immediate container intended or suitable for delivery to users, label(s) based upon the then current, generally accepted,
the label can be a display of such matter directly upon the well-established scientific knowledge. If an art material pro-
article involved or upon a tag or other suitable labeling device ducer or repackager becomes newly aware of any significant
attached to the art material. information regarding the chronic hazards of an art material or
2.1.7 producer—the person or entity who manufactures, ways to protect against the chronic hazard, this new informa-
processes, or imports an art material. tion must be incorporated into the labels of such art materials
2.1.8 repackager—the person or entity who obtains materi- that are manufactured after 12 months from the date of
als from producers and without making changes in such discovery. If a producer or repackager reformulates an art
materials puts them in containers intended for sale as art material, the new information must be evaluated and labeled in
materials to users. accordance with Section 5 of this practice.
2.1.9 sensitizer—a substance known to cause, through an 3.6 Statement of Conformance—“Conforms to ASTM Prac-
allergic process, a chronic adverse health effect which becomes tice D 4236,” or “Conforms to ASTM D4236,” or “Conforms
evident in a significant number of people on re-exposure to the to the health requirements of ASTM D4236.” This statement
same substance. may be combined with other conformance statements. The
2.1.10 toxic—applies to any substance that is likely to purpose of the conformance statement is to inform the pur-
produce personal injury or illness to humans through ingestion, chaser, at the time of purchase, of the product’s compliance
inhalation, or skin contact. with the standard. To accomplish this purpose the conformance
2.1.11 toxicologist—an individual who through education, statement should appear whenever practical on the product;
training, and experience has expertise in the field of toxicology, however, it shall also be acceptable to place the statement on
as it relates to human exposure, and is either a toxicologist or one or more of the following: (a) the individual product
physician certified by a nationally recognized certification package, (b) a display or sign at the point of purchase, (c)
board. separate explanatory literature available on request at the point
2.1.12 users—artists or crafts people of any age who create, of purchase, (d) a response to a formal request for bid or
or recreate in a limited number, largely by hand, works which proposal.
may or may not have a practical use, but in which aesthetic
4. Determination of Labeling
considerations are paramount.
4.1 An art material is considered to have the potential for
3. Requirements
producing chronic adverse health effects if any customary or
3.1 To conform to this voluntary practice the producer or
reasonably foreseeable use can result in a chronic hazard.
repackager of art materials shall submit art material product 4.2 In making the determination a toxicologist(s) shall take
formulation(s) or reformulation(s) to a toxicologist for review,
into account the following:
such review to be in accordance with Section 4 of this practice. 4.2.1 Current chemical composition of the art material,
The toxicologist shall be required to keep product formula-
supplied by an analytical laboratory or by an industrial chemist
tion(s) confidential. on behalf of a manufacturer or repackager.
3.1.1 Unless otherwise agreed in writing by the producer or
4.2.2 Current generally accepted, well-established scientific
repackager, no one other than the toxicologist shall have access
knowledge of the chronic toxic potential of each component
to the formulation(s); except that the toxicologist shall furnish
and the total formulation.
a patient’s physician, on a confidential basis, the information
necessary to diagnose or treat cases of exposure or accidental
Two of the larger poison exposure management information sources are: The
ingestion.
Rocky Mountain Poison Control Center, West 8th and Cherokee. Denver, CO
3.2 To conform to this practice, the producer or repackager,
80204; and the National Poison Center Network, 125 De Soto St., Pittsburgh, PA
upon advice given by a toxicologist in accordance with Section 15213.
D 4236
4.2.3 Specific physical and chemical form of the art material chronic adverse health effects, the potential effects may be
product, bioavailability, concentration, and the amount of each combined into one statement.
potentially chronic toxic component found in the formulation.
5.7 Information Sources—In addition to an appropriate
4.2.4 Reasonably foreseeable uses of the art material prod-
telephone number, the precautionary label shall contain a
uct as determined by consultation with users and other indi-
statement identifying a source for additional health information
viduals who are experienced in use of the material(s), such as
substantially in conformance with one of the phrases listed
teachers, or by market studies, unless such use information has
below:
previously been determined with respect to the specific art
5.7.1 For more health information—(24-h cost-free tele-
material(s) under review.
phone number), or
4.2.5 Potential for known synergism and antagonism of the
5.7.2 For further health information call a poison control
various components of the formulation.
center.
4.2.6 Potentially chronic adverse health effects of decom-
5.8 Labeling Content, Product Size—An art material prod-
position or combustion products, if known, from any reason-
uct(s) in a container larger in size than one fluid ounce (30 mL)
ably foreseeable use of the hazardous art material product.
(if the product is sold by volume) or one ounce net weight (28
4.2.7 Opinions of various regulatory agencies and scientific
g) (if the product is sold by weight) shall have full precaution-
bodies, including the International Agency for Research on
ary labeling, as generally described in Section 5 of this
Cancer and the National Cancer Institute, on the potential for
practice. An art material product(s) in a container equal to or
chronic adverse health effects of the various components of the
smaller than one fluid ounce or one ounce net weight shall have
formulation.
a label that includes a signal word in conformance with 5.1 of
4.3 Based upon the conclusion reached in conformance with
this practice and a list of potentially harmful or sensitizing
review determinations set forth herein the toxicologist(s) shall
components in conformance with 5.3 and 5.5 of this practice.
recommend precautionary labeling consistent with Section 5 of
If the toxicologist determines that an art material in a container
this practice.
equal to or smaller than one fluid ounce (30 mL) or one ounce
net weight (28 g) has the potential for producing chronic
5. Labeling Practices
adverse health effects with customary or reasonably foresee-
5.1 Signal Word:
able use despite its small size, the toxicologist may require the
5.1.1 When a signal word for an acute hazard(s) is mandated
product to carry all the labeling that would be required in a
and a chronic hazard(s) exists, the signal word shall be that for
larger package. When the information cannot fit on the package
the acute hazard.
label, the art material shall include a package insert that
5.1.2 When only a chronic hazard(s) exists, the signal word
conveys all the required information. If the art material has a
WARNING shall be used.
package insert, the label on the product shall include a signal
5.1.3 The signal word shall be prominently visible and set in
word in conformance with 5.1, a list of potentially harmful or
bold capital
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