[Title 16 CFR C]
[Code of Federal Regulations (annual edition) - January 1, 2002 Edition]
[Title 16 - COMMERCIAL PRACTICES]
[Chapter II - CONSUMER PRODUCT SAFETY COMMISSION]
[Subchapter C - FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS]
[From the U.S. Government Printing Office]
16COMMERCIAL PRACTICES22002-01-012002-01-01falseFEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONSCSUBCHAPTER CCOMMERCIAL PRACTICESCONSUMER PRODUCT SAFETY COMMISSION
SUBCHAPTER C--FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS--Table of Contents
Sec.
1500.1 Scope of subchapter.
1500.2 Authority.
1500.3 Definitions.
1500.4 Human experience with hazardous substances.
1500.5 Hazardous mixtures.
1500.12 Products declared to be hazardous substances under section 3(a)
of the act.
1500.13 Listing of ``strong sensitizer'' substances.
1500.14 Products requiring special labeling under section 3(b) of the
act.
1500.15 Labeling of fire extinguishers.
1500.17 Banned hazardous substances.
1500.18 Banned toys and other banned articles intended for use by
children.
1500.19 Misbranded toys and other articles intended for use by children.
1500.40 Method of testing toxic substances.
1500.41 Method of testing primary irritant substances.
1500.42 Test for eye irritants.
1500.43 Method of test for flashpoint of volatile flammable materials by
Tagliabue open-cup apparatus.
1500.43a Method of test for flashpoint of volatile flammable materials.
1500.44 Method for determining extremely flammable and flammable solids.
1500.45 Method for determining extremely flammable and flammable
contents of self-pressurized containers.
1500.46 Method for determining flashpoint of extremely flammable
contents of self-pressurized containers.
1500.47 Method for determining the sound pressure level produced by toy
caps.
1500.48 Technical requirements for determining a sharp point in toys and
other articles intended for use by children under 8 years of
age.
1500.49 Technical requirements for determining a sharp metal or glass
edge in toys and other articles intended for use by children
under 8 years of age.
1500.50 Test methods for simulating use and abuse of toys and other
articles intended for use by children.
1500.51 Test methods for simulating use and abuse of toys and other
articles intended for use by children 18 months of age or
less.
1500.52 Test methods for simulating use and abuse of toys and other
articles intended for use by children over 18 but not over 36
months of age.
1500.53 Test methods for simulating use and abuse of toys and other
articles intended for use by children over 36 but not over 96
months of age.
1500.81 Exemptions for food, drugs, cosmetics, and fuels.
1500.82 Exemption from full labeling and other requirements.
1500.83 Exemptions for small packages, minor hazards, and special
circumstances.
1500.85 Exemptions from classification as banned hazardous substances.
1500.86 Exemptions from classification as a banned toy or other banned
article for use by children.
1500.121 Labeling requirements; prominence, placement, and
conspicuousness.
1500.122 Deceptive use of disclaimers.
1500.123 Condensation of label information.
1500.125 Labeling requirements for accompanying literature.
1500.126 Substances determined to be ``special hazards.''
1500.127 Substances with multiple hazards.
1500.128 Label comment.
1500.129 Substances named in the Federal Caustic Poison Act.
1500.130 Self-pressurized containers: labeling.
1500.133 Extremely flammable contact adhesives; labeling.
1500.134 Policy on first aid labeling for saline emesis.
1500.135 Summary of guidelines for determining chronic toxicity.
1500.210 Responsibility.
1500.211 Guaranty.
1500.212 Definition of guaranty; suggested forms.
1500.213 Presentation of views under section 7 of the act.
1500.214 Examinations and investigations; samples.
1500.230 Guidance for lead (Pb) in consumer products.
1500.231 Guidance for hazardous liquid chemicals in children's products.
Imports
1500.265 Imports; definitions.
1500.266 Notice of sampling.
1500.267 Payment for samples.
1500.268 Hearing.
1500.269 Application for authorization.
1500.270 Granting of authorization.
1500.271 Bonds.
1500.272 Costs chargeable in connection with relabeling and
reconditioning inadmissible imports.
[[Page 404]]
Authority: 15 U.S.C. 1261-1278.
Source: 38 FR 27012, Sept. 27, 1973, unless otherwise noted.
Sec. 1500.1 Scope of subchapter.
Set forth in this subchapter C are the regulations of the Consumer
Product Safety Commission issued pursuant to and for the implementation
of the Federal Hazardous Substances Act as amended (see
Sec. 1500.3(a)(1)).
Sec. 1500.2 Authority.
Authority under the Federal Hazardous Substances Act is vested in
the Consumer Product Safety Commission by section 30(a) of the Consumer
Product Safety Act (15 U.S.C. 2079(a)).
Sec. 1500.3 Definitions.
(a) Certain terms used in this part. As used in this part:
(1) Act means the Federal Hazardous Substances Act (Pub. L. 86-613,
74 Stat. 372-81 (15 U.S.C. 1261-74)) as amended by:
(i) The Child Protection Act of 1966 (Pub. L. 89-756, 80 Stat. 1303-
05).
(ii) The Child Protection and Toy Safety Act of 1969 (Pub. L. 91-
113, 83 Stat. 187-90).
(iii) The Poison Prevention Packaging Act of 1970 (Pub. L. 91-601,
84 Stat. 1670-74).
(2) Commission means the Consumer Product Safety Commission
established May 14, 1973, pursuant to provisions of the Consumer Product
Safety Act (Pub. L. 92-573, 86 Stat. 1207-33 (15 U.S.C. 2051-81)).
(b) Statutory definitions. Except for the definitions given in
section 2 (c) and (d) of the act, which are obsolete, the definitions
set forth in section 2 of the act are applicable to this part and are
repeated for convenience as follows (some of these statutory definitions
are interpreted, supplemented, or provided with alternatives in
paragraph (c) of this section):
(1) Territory means any territory or possession of the United
States, including the District of Columbia and the Commonwealth of
Puerto Rico but excluding the Canal Zone.
(2) Interstate commerce means (i) commerce between any State or
territory and any place outside thereof and (ii) commerce within the
District of Columbia or within any territory not organized with a
legislative body.
(3) Person includes an individual, partnership, corporation, and
association.
(4)(i) Hazardous substance means:
(A) Any substance or mixture of substances which is toxic,
corrosive, an irritant, a strong sensitizer, flammable or combustible,
or generates pressure through decomposition, heat, or other means, if
such substance or mixture of substances may cause substantial personal
injury or substantial illness during or as a proximate result of any
customary or reasonably foreseeable handling or use, including
reasonably foreseeable ingestion by children.
(B) Any substance which the Commission by regulation finds, pursuant
to the provisions of section 3(a) of the act, meet the requirements of
section 2(f)(1)(A) of the act (restated in (A) above).
(C) Any radioactive substance if, with respect to such substance as
used in a particular class of article or as packaged, the Commission
determines by regulation that the substance is sufficiently hazardous to
require labeling in accordance with the act in order to protect the
public health.
(D) Any toy or other article intended for use by children which the
Commission by regulation determines, in accordance with section 3(e) of
the act, presents an electrical, mechanical, or thermal hazard.
(ii) Hazardous substance shall not apply to pesticides subject to
the Federal Insecticide, Fungicide, and Rodenticide Act, to foods,
drugs, and cosmetics subject to the Federal Food, Drug, and Cosmetic
Act, nor to substances intended for use as fuels when stored in
containers and used in the heating, cooking, or refrigeration system of
a house. ``Hazardous substance'' shall apply, however, to any article
which is not itself a pesticide within the meaning of the Federal
Insecticide, Fungicide, and Rodenticide Act but which is a hazardous
substance within the meaning of section 2(f)(1) of the Federal Hazardous
Substances Act (restated in paragraph (b)(4)(i) of this section) by
reason of bearing or containing such a pesticide.
[[Page 405]]
(iii) Hazardous substance shall not include any source material,
special nuclear material, or byproduct material as defined in the Atomic
Energy Act of 1954, as amended, and regulations issued pursuant thereto
by the Atomic Energy Commission.
(5) Toxic shall apply to any substance (other than a radioactive
substance) which has the capacity to produce personal injury or illness
to man through ingestion, inhalation, or absorption through any body
surface.
(6)(i) Highly toxic means any substance which falls within any of
the following categories:
(A) Produces death within 14 days in half or more than half of a
group of 10 or more laboratory white rats each weighing between 200 and
300 grams, at a single dose of 50 milligrams or less per kilogram of
body weight, when orally administered; or
(B) Produces death within 14 days in half or more than half of a
group of 10 or more laboratory white rats each weighing between 200 and
300 grams, when inhaled continuously for a period of 1 hour or less at
an atmospheric concentration of 200 parts per million by volume or less
of gas or vapor or 2 milligrams per liter by volume or less of mist or
dust, provided such concentration is likely to be encountered by man
when the substance is used in any reasonably foreseeable manner; or
(C) Produces death within 14 days in half or more than half of a
group of 10 or more rabbits tested in a dosage of 200 milligrams or less
per kilogram of body weight, when administered by continuous contact
with the bare skin for 24 hours or less.
(ii) If the Commission finds that available data on human experience
with any substance indicate results different from those obtained on
animals in the dosages and concentrations specified in paragraph
(b)(6)(i) of this section, the human data shall take precedence.
(7) Corrosive means any substance which in contact with living
tissue will cause destruction of tissue by chemical action, but shall
not refer to action on inanimate surfaces.
(8) Irritant means any substance not corrosive within the meaning of
section 2(i) of the act (restated in paragraph (b)(7) of this section)
which on immediate, prolonged, or repeated contact with normal living
tissue will induce a local inflammatory reaction.
(9) Strong sensitizer means a substance which will cause on normal
living tissue through an allergic or photodynamic process a
hypersensitivity which becomes evident on reapplication of the same
substance and which is designated as such by the Commission. Before
designating any substance as a strong sensitizer, the Commission, upon
consideration of the frequency of occurrence and severity of the
reaction, shall find that the substance has a significant potential for
causing hypersensitivity.
(10) The terms extremely flammable, flammable, and combustible as
they apply to any substances, liquid, solid, or the contents of any
self-pressurized container, are defined by regulations issued by the
Commission and published at Sec. 1500.3(c)(6).
(11) Radioactive substance means a substance which emits ionizing
radiation.
(12) Label means a display of written, printed, or graphic matter
upon the immediate container of any substance or, in the cases of an
article which is unpackaged or is not packaged in an immediate container
intended or suitable for delivery to the ultimate consumer, a display of
such matter directly upon the article involved or upon a tag or other
suitable material affixed thereto. A requirement made by or under
authority of the act that any word, statement, or other information
appear on the label shall not be considered to be complied with unless
such word, statement, or other information also appears (i) on the
outside container or wrapper, if any there be, unless it is easily
legible through the outside container or wrapper and (ii) on all
accompanying literature where there are directions for use, written or
otherwise.
(13) Immediate container does not include package liners.
(14) Misbranded hazardous substance means a hazardous substance
(including a toy, or other article intended for use by children, which
is a hazardous substance, or which bears or contains a hazardous
substance in such manner as
[[Page 406]]
to be susceptible of access by a child to whom such toy or other article
is entrusted) intended, or packaged in a form suitable, for use in the
household or by children, if the packaging or labeling of such substance
is in violation of an applicable regulation issued pursuant to section 3
or 4 of the Poison Prevention Packaging Act of 1970 or if such
substance, except as otherwise provided by or pursuant to section 3 of
the act (Federal Hazardous Substances Act), fails to bear a label:
(i) Which states conspicuously:
(A) The name and place of business of the manufacturer, packer,
distributor, or seller;
(B) The common or usual name or the chemical name (if there be no
common or usual name) of the hazardous substance or of each component
which contributes substantially to its hazard, unless the Commission by
regulation permits or requires the use of a recognized generic name;
(C) The signal word ``DANGER'' on substances which are extremely
flammable, corrosive, or highly toxic;
(D) The signal word ``WARNING'' or ``CAUTION'' on all other
hazardous substances;
(E) An affirmative statement of the principal hazard or hazards,
such as ``Flammable,'' ``Combustible,'' ``Vapor Harmful,'' ``Causes
Burns,'' ``Absorbed Through Skin,'' or similar wording descriptive of
the hazard;
(F) Precautionary measures describing the action to be followed or
avoided, except when modified by regulation of the Commission pursuant
to section 3 of the act;
(G) Instruction, when necessary or appropriate, for first-aid
treatment;
(H) The word Poison for any hazardous substance which is defined as
``highly toxic'' by section 2(h) of the act (restated in paragraph
(b)(6) of this section);
(I) Instructions for handling and storage of packages which require
special care in handling or storage; and
(J) The statement (1) ``Keep out of the reach of children'' or its
practical equivalent, or, (2) if the article is intended for use by
children and is not a banned hazardous substance, adequate directions
for the protection of children from the hazard; and
(ii) On which any statements required under section 2(p)(1) of the
act (restated in paragraph (b)(14)(i) of this section) are located
prominently and are in the English language in conspicuous and legible
type in contrast by typography, layout, or color with other printed
matter on the label.
Misbranded hazardous substance also means a household substance as
defined in section 2(2)(D) of the Poison Prevention Packaging Act of
1970 if it is a substance described in section 2(f)(1) of the Federal
Hazardous Substances Act (restated in paragraph (b)(4)(i)(A) of this
section) and its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 3 or 4 of the Poison Prevention
Packaging Act of 1970.
(15)(i) Banned hazardous substance means:
(A) Any toy, or other article intended for use by children, which is
a hazardous substance, or which bears or contains a hazardous substance
in such manner as to be susceptible of access by a child to whom such
toy or other article is entrusted; or
(B) Any hazardous substance intended, or packaged in a form
suitable, for use in the household, which the Commission by regulation
classifies as a ``banned hazardous substance'' on the basis of a finding
that, notwithstanding such cautionary labeling as is or may be required
under the act for that substance, the degree or nature of the hazard
involved in the presence or use of such substance in households is such
that the objective of the protection of the public health and safety can
be adequately served only by keeping such substance, when so intended or
packaged, out of the channels of interstate commerce; Provided, That the
Commission by regulation (1) shall exempt from section 2(q)(1)(A) of the
act (restated in paragraph (b)(15)(i)(A) of this section) articles, such
as chemistry sets, which by reason of their functional purpose require
the inclusion of the hazardous substance involved, or necessarily
present an electrical, mechanical, or thermal hazard, and which bear
labeling giving adequate directions and warnings for safe
[[Page 407]]
use and are intended for use by children who have attained sufficient
maturity, and may reasonably be expected, to read and heed such
directions and warnings, and (2) shall exempt from section 2(q)(1)(A) of
the act (restated in paragraph (b)(15)(i)(A) of this section), and
provide for the labeling of, common fireworks (including toy paper caps,
cone fountains, cylinder fountains, whistles without report, and
sparklers) to the extent that the Commission determines that such
articles can be adequately labeled to protect the purchasers and users
thereof.
(ii) Proceedings for the issuance, amendment, or repeal of
regulations pursuant to section 2(q)(1)(B) of the act (restated in
paragraph (b)(15)(i)(B) of this section) shall be governed by the
provisions of section 701 (e), (f), and (g) of the Federal Food, Drug,
and Cosmetic Act: Provided, That if the Commission finds that the
distribution for household use of the hazardous substance involved
presents an imminent hazard to the public health, the Commission may by
order published in the Federal Register give notice of such finding, and
thereupon such substance when intended or offered for household use, or
when so packaged as to be suitable for such use, shall be deemed to be a
``banned hazardous substance'' pending the completion of proceedings
relating to the issuance of such regulations.
(16) ``Electrical hazard''--an article may be determined to present
an electrical hazard if, in normal use or when subjected to reasonably
foreseeable damage or abuse, its design or manufacture may cause
personal injury or illness by electric shock.
(17) ``Mechanical hazard''--an article may be determined to present
a mechanical hazard if, in normal use or when subjected to reasonably
foreseeable damage or abuse, its design or manufacture presents an
unreasonable risk of personal injury or illness:
(i) From fracture, fragmentation, or disassembly of the article;
(ii) From propulsion of the article (or any part or accessory
thereof);
(iii) From points or other protrusions, surfaces, edges, openings,
or closures;
(iv) From moving parts;
(v) From lack or insufficiency of controls to reduce or stop motion;
(vi) As a result of self-adhering characteristics of the article;
(vii) Because the article (or any part or accessory thereof) may be
aspirated or ingested;
(viii) Because of instability; or
(ix) Because of any other aspect of the article's design or
manufacture.
(18) ``Thermal hazard''--an article may be determined to present a
thermal hazard if, in normal use or when subjected to reasonably
foreseeable damage or abuse, its design or manufacture presents an
unreasonable risk of personal injury or illness because of heat as from
heated parts, substances, or surfaces.
(c) Certain statutory definitions interpreted, supplemented, or
provided with alternatives. The following items interpret, supplement,
or provide alternatives to definitions set forth in section 2 of the act
(and restated in paragraph (b) of this section):
(1) To provide flexibility as to the number of animals tested, the
following is an alternative to the definition of ``highly toxic'' in
section 2(h) of the act (and paragraph (b)(6) of this section); Highly
toxic means:
(i) A substance determined by the Commission to be highly toxic on
the basis of human experience; and/or
(ii) A substance that produces death within 14 days in half or more
than half of a group of:
(A) White rats (each weighing between 200 and 300 grams) when a
single dose of 50 milligrams or less per kilogram of body weight is
administered orally;
(B) White rats (each weighing between 200 and 300 grams) when a
concentration of 200 parts per million by volume or less of gas or
vapor, or 2 milligrams per liter by volume or less of mist or dust, is
inhaled continuously for 1 hour or less, if such concentration is likely
to be encountered by man when the substance is used in any reasonably
foreseeable manner; and/or
(C) Rabbits (each weighing between 2.3 and 3.0 kilograms) when a
dosage of 200 milligrams or less per kilogram of body weight is
administered by continuous contact with the bare skin for 24
[[Page 408]]
hours or less by the method described in Sec. 1500.40.
The number of animals tested shall be sufficient to give a statistically
significant result and shall be in conformity with good pharmacological
practices.
(2) To give specificity to the definition of ``toxic'' in section
2(g) of the act (and restated in paragraph (b)(5) of this section), the
following supplements that definition. The following categories are not
intended to be inclusive.
(i) Acute toxicity. Toxic means any substance that produces death
within 14 days in half or more than half of a group of:
(A) White rats (each weighing between 200 and 300 grams) when a
single dose of from 50 milligrams to 5 grams per kilogram of body weight
is administered orally. Substances falling in the toxicity range between
500 milligrams and 5 grams per kilogram of body weight will be
considered for exemption from some or all of the labeling requirements
of the act, under Sec. 1500.82, upon a showing that such labeling is not
needed because of the physical form of the substances (solid, a thick
plastic, emulsion, etc.), the size or closure of the container, human
experience with the article, or any other relevant factors;
(B) White rats (each weighing between 200 and 300 grams) when an
atmospheric concentration of more than 200 parts per million but not
more than 20,000 parts per million by volume of gas or vapor, or more
than 2 but not more than 200 milligrams per liter by volume of mist or
dust, is inhaled continuously for 1 hour or less, if such concentration
is likely to be encountered by man when the substance is used in any
reasonably foreseeable manner: and/or
(C) Rabbits (each weighing between 2.3 and 3.0 kilograms) when a
dosage of more than 200 milligrams but not more than 2 grams per
kilogram of body weight is administered by continuous contact with the
bare skin for 24 hours by the method described in Sec. 1500.40.
The number of animals tested shall be sufficient to give a statistically
significant result and shall be in conformity with good pharmacological
practices. ``Toxic'' also applies to any substance that is ``toxic''
(but not ``highly toxic'') on the basis of human experience.
(ii) Chronic toxicity. A substance is toxic because it presents a
chronic hazard if it falls into one of the following categories. (For
additional information see the chronic toxicity guidelines at 16 CFR
1500.135.)
(A) For Carcinogens. A substance is toxic if it is or contains a
known or probable human carcinogen.
(B) For Neurotoxicological Toxicants. A substance is toxic if it is
or contains a known or probable human neurotoxin.
(C) For Developmental or Reproductive Toxicants. A substance is
toxic if it is or contains a known or probable human developmental or
reproductive toxicant.
(3) The definition of corrosive in section 2(i) of the act (restated
in paragraph (b)(7) of this section) is interpreted to also mean the
following: Corrosive means a substance that causes visible destruction
or irreversible alterations in the tissue at the site of contact. A test
for a corrosive substance is whether, by human experience, such tissue
destruction occurs at the site of application. A substance would be
considered corrosive to the skin if, when tested on the intact skin of
the albino rabbit by the technique described in Sec. 1500.41, the
structure of the tissue at the site of contact is destroyed or changed
irreversibly in 24 hours or less. Other appropriate tests should be
applied when contact of the substance with other than skin tissue is
being considered.
(4) The definition of irritant in section 2(j) of the act (restated
in paragraph (b)(8) of this section) is supplemented by the following:
Irritant includes ``primary irritant to the skin'' as well as substances
irritant to the eye or to mucous membranes. Primary irritant means a
substance that is not corrosive and that human experience data indicate
is a primary irritant and/or means a substance that results in an
empirical score of five or more when tested by the method described in
Sec. 1500.41. Eye irritant means a substance that human experience data
indicate is an irritant to the eye and/or means a substance for which a
positive test is obtained when tested by the method described in
Sec. 1500.42.
[[Page 409]]
(5) The definition of strong sensitizer in section 2(k) of the
Federal Hazardous Substances Act (restated in 16 CFR 1500.3(b)(9)) is
supplemented by the following definitions:
(i) Sensitizer. A sensitizer is a substance that will induce an
immunologically-mediated (allergic) response, including allergic
photosensitivity. This allergic reaction will become evident upon
reexposure to the same substance. Occasionally, a sensitizer will induce
and elicit an allergic response on first exposure by virtue of active
sensitization.
(ii) Strong. In determining that a substance is a ``strong''
sensitizer, the Commission shall consider the available data for a
number of factors. These factors should include any or all of the
following (if available): Quantitative or qualitative risk assessment,
frequency of occurrence and range of severity of reactions in healthy or
susceptible populations, the result of experimental assays in animals or
humans (considering dose-response factors), with human data taking
precedence over animal data, other data on potency or bioavailability of
sensitizers, data on reactions to a cross-reacting substance or to a
chemical that metabolizes or degrades to form the same or a cross-
reacting substance, the threshold of human sensitivity, epidemiological
studies, case histories, occupational studies, and other appropriate in
vivo and in vitro test studies.
(iii) Severity of reaction. The minimal severity of reaction for the
purpose of designating a material as a ``strong sensitizer'' is a
clinically important allergic reaction. For example, strong sensitizers
may produce substantial illness, including any or all of the following:
physical discomfort, distress, hardship, and functional or structural
impairment. These may, but not necessarily, require medical treatment or
produce loss of functional activities.
(iv) Significant potential for causing hypersensitivity.
``Significant potential for causing hypersensitivity'' is a relative
determination that must be made separately for each substance. It may be
based upon the chemical or functional properties of the substance,
documented medical evidence of allergic reactions obtained from
epidemiological surveys or individual case reports, controlled in vitro
or in vivo experimental assays, or susceptibility profiles in normal or
allergic subjects.
(v) Normal living tissue. The allergic hypersensitivity reaction
occurs in normal living tissues, including the skin and other organ
systems, such as the respiratory or gastrointestinal tract, either
singularly or in combination, following sensitization by contact,
ingestion, or inhalation.
(6) The Consumer Product Safety Commission, by the regulations
published in this section, defines the terms extremely flammable,
flammable, and combustible, appearing in section 2(1) of the Federal
Hazardous Substances Act, as follows:
(i) The term extremely flammable shall apply to any substance which
has a flashpoint at or below 20 deg.F (-6.7 deg.C) as determined by
the test method described at Sec. 1500.43a, except that, any mixture
having one component or more with a flashpoint higher than 20 deg.F (-
6.7 deg.C) which comprises at least 99 percent of the total volume of
the mixture is not considered to be an extremely flammable substance.
(ii) The term flammable shall apply to any substance having a
flashpoint above 20 deg.F (-6.7 deg.C) and below 100 deg.F (37.8
deg.C), as determined by the method described at Sec. 1500.43a, except
that:
(A) Any mixture having one component or more with a flashpoint at or
above 100 deg.F (37.8 deg.C) which comprises at least 99 percent of
the total volume of the mixture is not considered to be a flammable
substance; and
(B) Any mixture containing 24 percent or less of water miscible
alcohols, by volume, in aqueous solution is not considered to be
flammable if the mixture does not present a significant flammability
hazard when used by consumers.
(iii) The term combustible shall apply to any substance having a
flashpoint at or above 100 deg.F (37.8 deg.C) to and including 150
deg.F (65.6 deg.C) as determined by the test method described at
Sec. 1500.43a, except that:
(A) Any mixture having one component or more with a flashpoint
higher than 150 deg.F (65.6 deg.C) which comprises at least 99 percent
of the total volume of
[[Page 410]]
the mixture is not considered to be a combustible hazardous substance;
and
(B) Any mixture containing 24 percent or less of water miscible
alcohols, by volume, in aqueous solution is not considered to be
combustible if the mixture does not present a significant flammability
hazard when used by consumers.
(iv) To determine flashpoint temperatures for purposes of enforcing
and administering requirements of the Federal Hazardous Substances Act
applicable to ``extremely flammable,'' ``flammable,'' and
``combustible'' hazardous substances, the Commission will follow the
procedures set forth in Sec. 1500.43a. However, the Commission will
allow manufacturers and labelers of substances and products subject to
those requirements to rely on properly conducted tests using the
Tagliabue open-cup method which was in effect prior to the issuance of
Sec. 1500.43a (as published at 38 FR 27012, September 27, 1973, and set
forth below), and the defintions of the terms ``extremely flammable,''
``flammable,'' and ``combustible'' in this section before its amendment
(as published at 38 FR 27012, September 27, 1983, and amended 38 FR
30105, November 1, 1973, set forth in the note following this section)
if all of the following conditions are met:
(A) The substance or product was subject to and complied with the
requirements of the Federal Hazardous Substances Act for ``extremely
flammable,'' ``flammable,'' or ``combustible'' hazardous substances
before the effective date of Sec. 1500.43a; and
(B) No change has been made to the formulation or labeling of such
substance or product after the effective date of Sec. 1500.43a,
prescribing a closed-cup test apparatus and procedure.
(v) Extremely flammable solid means a solid substance that ignites
and burns at an ambient temperature of 80 deg.F or less when subjected
to friction, percussion, or electrical spark.
(vi) Flammable solid means a solid substance that, when tested by
the method described in Sec. 1500.44, ignites and burns with a self-
sustained flame at a rate greater than one-tenth of an inch per second
along its major axis.
(vii) Extremely flammable contents of self-pressurized container
means contents of a self-pressurized container that, when tested by the
method described in Sec. 1500.45, a flashback (a flame extending back to
the dispenser) is obtained at any degree of valve opening and the
flashpoint, when tested by the method described in Sec. 1500.43a is less
than 20 deg.F (-6.7 deg.C).
(viii) Flammable contents of self-pressurized container means
contents of a self-pressurized container that, when tested by the method
described in Sec. 1500.45, a flame projection exceeding 18 inches is
obtained at full valve opening, or flashback (a flame extending back to
the dispenser) is obtained at any degree of valve opening.
(7) The definition of hazardous substance in section 2(f)(1)(A) of
the act (restated in paragraph (b)(4)(i)(A) of this section) is
supplemented by the following definitions or interpretations or terms
used therein:
(i) A substance or mixture of substances that ``generates pressure
through decomposition, heat, or other means'' is a hazardous substance:
(A) If it explodes when subjected to an electrical spark,
percussion, or the flame of a burning paraffin candle for 5 seconds or
less.
(B) If it expels the closure of its container, or bursts its
container, when held at or below 130 deg.F. for 2 days or less.
(C) If it erupts from its opened container at a temperature of 130
deg.F. or less after having been held in the closed container at 130
deg.F. for 2 days.
(D) If it comprises the contents of a self-pressurized container.
(ii) Substantial personal injury or illness means any injury or
illness of a significant nature. It need not be severe or serious. What
is excluded by the word ``substantial'' is a wholly insignificant or
negligible injury or illness.
(iii) Proximate result means a result that follows in the course of
events without an unforeseeable, intervening, independent cause.
(iv) Reasonably foreseeable handling or use includes the reasonably
foreseeable accidental handling or use, not only by the purchaser or
intended user of the product, but by all others in a household,
especially children.
[[Page 411]]
(8) The definition of ``radioactive substance'' in section 2(m) of
the act (restated in paragraph (b)(11) of this section) is supplemented
by the following: Radioactive substance means a substance which, because
of nuclear instability, emits electromagnetic and/or particulate
radiation capable of producing ions in its passage through matter.
Source materials, special nuclear material, and byproduct materials
described in section 2(f)(3) of the act are exempt.
(9) In the definition of ``label'' in section 2(n) of the act
(restated in paragraph (b)(12) of this section), a provision stipulates
that words, statements, or other information required to be on the label
must also appear on all accompanying literature where there are
directions for use, written or otherwise. To make this provision more
specific, ``accompanying literature'' is interpreted to mean any
placard, pamphlet, booklet, book, sign, or other written, printed, or
graphic matter or visual device that provides directions for use,
written or otherwise, and that is used in connection with the display,
sale, demonstration, or merchandising of a hazardous substance intended
for or packaged in a form suitable for use in the household or by
children.
(10) The definition of ``misbranded hazardous substance'' in section
2(p) of this act (restated in paragraph (b)(14) of this section) is
supplemented by the following definitions or interpretations of terms
used therein:
(i) Hazardous substances intended, or packaged in a form suitable,
for use in the household means any hazardous substance, whether or not
packaged, that under any customary or reasonably foreseeable condition
of purchase, storage, or use may be brought into or around a house,
apartment, or other place where people dwell, or in or around any
related building or shed including, but not limited to, a garage,
carport, barn, or storage shed. The term includes articles, such as
polishes or cleaners, designed primarily for professional use but which
are available in retail stores, such as hobby shops, for nonprofessional
use. Also included are items, such as antifreeze and radiator cleaners,
that although principally for car use may be stored in or around
dwelling places. The term does not include industrial supplies that
might be taken into a home by a serviceman. An article labeled as, and
marketed solely for, industrial use does not become subject to this act
because of the possibility that an industrial worker may take a supply
for his own use. Size of unit or container is not the only index of
whether the article is suitable for use in or around the household; the
test shall be whether under any reasonably foreseeable condition of
purchase, storage, or use the article may be found in or around a
dwelling.
(ii) Conspicuously in section 2(p)(1) of the act and prominently and
conspicuous in section 2(p)(2) of the act mean that, under customary
conditions of purchase, storage, and use, the required information shall
be visible, noticeable, and in clear and legible English. Some factors
affecting a warning's prominence and conspicuousness are: Location, size
of type, and contrast of printing against background. Also bearing on
the effectiveness of a warning might be the effect of the package
contents if spilled on the label.
Note: The definitions of extremely flammable, flammable, and
combustible hazardous substances set forth above in paragraphs (b)(10)
and (c)(6) are effective August 10, 1987. The definitions remaining in
effect until August 10, 1987, as published at 38 FR 27012, Sept. 27,
1973, and amended at 38 FR 30105, Nov. 1, 1973, are set forth below.
Manufacturers and labelers of products subject to the Federal Hazardous
Substances Act may continue to use these definitions for labeling of
those products under the conditions set forth in Sec. 1500.3(c)(6)(iv),
as amended.
(b)(10) Extremely flammable shall apply to any substance which has a
flashpoint at or below 20 deg.F. as determined by the Tagliabue Open
Cup Tester; flammable shall apply to any substance which has a
flashpoint of above 20 deg.F., to and including 80 deg.F., as
determined by the Tagliabue Open Cup Tester; and combustible shall apply
to any substance which has a flashpoint above 80 deg.F. to and
including 150 deg.F., as determined by the Tagliabue Open Cup Tester;
except that the flammability or combustibility of solids and of the
contents of self-pressurized containers shall be determined by methods
found by the Commission to be generally applicable to such materials or
containers, respectively, and established by regulations issued by the
[[Page 412]]
Commission, which regulations shall also define the terms flammable,
combustible, and extremely flammable in accord with such methods.
* * * * *
(c)(6)(i) Extremely flammable means any substance that has a
flashpoint at or below 20 deg.F. as determined by the method described
in Sec. 1500.43.
(ii) Flammable means any substance that has a flashpoint of above 20
deg.F., to and including 80 deg.F., as determined by the method
described in Sec. 1500.43.
[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 30105, Nov. 1, 1973;
49 FR 22465, May 30, 1984; 51 FR 28536, Aug. 8, 1986; 51 FR 29096, Aug.
14, 1986; 51 FR 30209, Aug. 25, 1986; 57 FR 46669, Oct. 9, 1992]
Sec. 1500.4 Human experience with hazardous substances.
(a) Reliable data on human experience with any substance should be
taken into account in determining whether an article is a ``hazardous
substance'' within the meaning of the act. When such data give reliable
results different from results with animal data, the human experience
takes precedence.
(b) Experience may show that an article is more or less toxic,
irritant, or corrosive to man than to test animals. It may show other
factors that are important in determining the degree of hazard to humans
represented by the substance. For example, experience shows that
radiator antifreeze is likely to be stored in the household or garage
and likely to be ingested in significant quantities by some persons. It
also shows that a particular substance in liquid form is more likely to
be ingested than the same substance in a paste or a solid and that an
aerosol is more likely to get into the eyes and the nasal passages than
a liquid.
Sec. 1500.5 Hazardous mixtures.
For a mixture of substances, the determination of whether the
mixture is a ``hazardous substance'' as defined by section 2(f) of the
act (repeated in Sec. 1500.3(b)(4)) should be based on the physical,
chemical, and pharmacological characteristics of the mixture. A mixture
of substances may therefore be less hazardous or more hazardous than its
components because of synergistic or antagonistic reactions. It may not
be possible to reach a fully satisfactory decision concerning the toxic,
irritant, corrosive, flammable, sensitizing, or pressure-generating
properties of a substance from what is known about its components or
ingredients. The mixture itself should be tested.
Sec. 1500.12 Products declared to be hazardous substances under section 3(a) of the act.
(a) The Commission finds that the following articles are hazardous
substances within the meaning of the act because they are capable of
causing substantial personal injury or substantial illness during or as
a proximate result of any customary or reasonably foreseeable handling
or use:
(1) Charcoal briquettes and other forms of charcoal in containers
for retail sale and intended for cooking or heating.
(2) [Reserved]
(b) [Reserved]
Sec. 1500.13 Listing of ``strong sensitizer'' substances.
On the basis of frequency of occurrence and severity of reaction
information, the Commission finds that the following substances have a
significant potential for causing hypersensitivity and therefore meet
the definition for ``strong sensitizer'' in section 2(k) of the act
(repeated in Sec. 1500.3(b)(9)):
(a) Paraphenylenediamine and products containing it.
(b) Powdered orris root and products containing it.
(c) Epoxy resins systems containing in any concentration
ethylenediamine, diethylenetriamine, and diglycidyl ethers of molecular
weight of less than 200.
(d) Formaldehyde and products containing 1 percent or more of
formaldehyde.
(e) Oil of bergamot and products containing 2 percent or more of oil
of bergamot.
Sec. 1500.14 Products requiring special labeling under section 3(b) of the act.
(a) Human experience, as reported in the scientific literature and
to the Poison Control Centers and the National
[[Page 413]]
Clearing House for Poison Control Centers, and opinions of informed
medical experts establish that the following substances are hazardous:
(1) Diethylene glycol and mixtures containing 10 percent or more by
weight of diethylene glycol.
(2) Ethylene glycol and mixtures containing 10 percent or more by
weight of ethylene glycol.
(3) Products containing 5 percent or more by weight of benzene (also
known as benzol) and products containing 10 percent or more by weight of
toluene (also known as toluol), xylene (also known as xylol), or
petroleum distillates such as kerosine, mineral seal oil, naphtha,
gasoline, mineral spirits, stoddard solvent, and related petroleum
distillates.
(4) Methyl alcohol (methanol) and mixtures containing 4 percent or
more by weight of methyl alcohol (methanol).
(5) Turpentine (including gum turpentine, gum spirits of turpentine,
steam-distilled wood turpentine, sulfate wood turpentine, and
destructively distilled wood turpentine) and mixtures containing 10
percent or more by weight of such turpentine.
(b) The Commission finds that the following substances present
special hazards and that, for these substances, the labeling required by
section 2(p)(1) of the act is not adequate for the protection of the
public health. Under section 3(b) of the act, the following specific
label statements are deemed necessary to supplement the labeling
required by section 2(p)(1) of the act:
(1) Diethylene glycol. Because diethylene glycol and mixtures
containing 10 percent or more by weight of diethylene glycol are
commonly marketed, stored, and used in a manner increasing the
possibility of accidental ingestion, such products shall be labeled with
the signal word ``warning'' and the statement ``Harmful if swallowed.''
(2) Ethylene glycol. Because ethylene glycol and mixtures containing
10 percent or more by weight of ethylene glycol are commonly marketed,
stored, and used in a manner increasing the possibility of accidental
ingestion, such products shall be labeled with the signal word
``warning'' and the statement ``Harmful or fatal if swallowed.''
(3) Benzene, toluene, xylene, petroleum distillates. (i) Because
inhalation of the vapors of products containing 5 percent or more by
weight of benzene may cause blood dyscrasias, such products shall be
labeled with the signal word ``danger,'' the statement of hazard ``Vapor
harmful,'' the word ``poison,'' and the skull and crossbones symbol. If
the product contains 10 percent or more by weight of benzene, it shall
bear the additional statement of hazard ``Harmful or fatal if
swallowed'' and the additional statement ``Call physician immediately.''
(ii) Because products containing 10 percent or more by weight of
toluene, xylene, or any of the other substances listed in paragraph
(a)(3) of this section may be aspirated into the lungs, with resulting
chemical pneumonitis, pneumonia, and pulmonary edema, such products
shall be labeled with the signal word ``danger,'' the statement or
hazard ``Harmful or fatal if swallowed,'' and the statement ``Call
physician immediately.''
(iii) Because inhalation of the vapor of products containing 10
percent or more by weight of toluene or xylene may cause systemic
injury, such products shall bear the statement of hazard ``Vapor
harmful'' in addition to the statements prescribed in paragraph
(b)(3)(ii) of this section.
(4) Methyl alcohol (methanol). Because death and blindness can
result from the ingestion of methyl alcohol, the label for this
substance and for mixtures containing 4 percent or more by weight of
this substance shall include the signal word ``danger,'' the additional
word ``poison,'' and the skull and crossbones symbol. The statement of
hazard shall include ``Vapor harmful'' and ``May be fatal or cause
blindness if swallowed.'' The label shall also bear the statement
``Cannot be made nonpoisonous.''
(5) Turpentine. Because turpentine (including gum turpentine, gum
spirits of turpentine, steam-distilled wood turpentine, sulfate wood
turpentine, and
[[Page 414]]
destructively distilled wood turpentine) and products containing 10
percent or more by weight of such turpentine, in addition to oral
toxicity resulting in systemic poisoning, may be aspirated into the
lungs with resulting chemical pneumonitis, pneumonia, and pulmonary
edema, such products shall be labeled with the signal word ``danger''
and the statement of hazard ``Harmful or fatal if swallowed.''
(6) Charcoal. Charcoal briquettes and other forms of charcoal in
containers for retail sale and intended for cooking or heating.
(i)(A) Because inhalation of the carbon monoxide produced by burning
charcoal indoors or in confined areas may cause serious injury or death,
containers of such products packaged before November 3, 1997, shall bear
the following borderlined statement:
------------------------------------------------------------------
WARNING: Do Not Use for Indoor Heating or Cooking Unless
Ventilation Is Provided for Exhausting Fumes to Outside.
Toxic Fumes May Accumulate and Cause Death
------------------------------------------------------------------
(B) For bags of charcoal packaged before November 3, 1997, the
statement specified in paragraph (b)(6)(i) of this section shall appear
within a heavy borderline in a color sharply contrasting to that of the
background, on both front and back panels in the upper 25 percent of the
panels of the bag at least 2 inches below the seam, and at least 1 inch
above any reading material or design elements in type size as follows:
The signal word ``WARNING'' shall appear in capital letters at least
three-eighths inch in height; the remaining text of the warning
statement shall be printed in letters at least three-sixteenths inch in
height.
(ii)(A) Because inhalation of the carbon monoxide produced by
burning charcoal indoors or in confined areas can cause serious injury
or death, containers of such products packaged on or after November 3,
1997, shall bear the following borderlined label.
[GRAPHIC] [TIFF OMITTED] TR03MY96.051
(B) Except as provided in paragraph (b)(6)(ii)(C) of this section,
the following requirements apply to bags of charcoal subject to
paragraph (b)(6)(ii)(A) of this section. The label specified in
paragraph (b)(6)(ii)(A) of this section shall appear within a heavy
borderline, in a color sharply contrasting to that of the background, on
both the front and back panels in the upper 25 percent of the panels of
the bag, and with the outer edge of the borderline at least 2.54 cm (1
inch) below the seam and at least 2.54 cm (1 inch) above any other
reading material or design elements. The signal word ``WARNING'' shall
be in bold capital letters in at least 7.14 mm (\9/32\ inch) type. The
remaining text of the warning statement shall be in at least 4.763 mm
(\3/16\ inch) type. The phrase ``CARBON MONOXIDE HAZARD'' shall be in
bold. This phrase and the word
[[Page 415]]
``NEVER'' shall be in all capital letters. The lettering shall have a
strokewidth-to-height ratio of 1:6 to 1:8. The label shall be at least
50.8 mm (2 inches) high and 147.5 mm (5\13/16\ inches) wide. The label's
lettering, spacing between the bottom of the letters of one line and the
top of the letter of the next line, and pictogram shall have the size
relation to each other and to the remainder of the label shown in
paragraph (b)(6)(ii)(A) of this section.
(C) For bags of charcoal subject to paragraph (b)(6)(ii)(A) of this
section that are 6 inches or less wide, the minimum label height may be
reduced to 38 mm (1.5 inches) and the minimum width may be reduced to
139.7 mm (5.5 inches). The signal word ``WARNING'' shall be in capital
letters in at least 6.32 mm (0.249 inch) type. The remaining text of the
warning shall be in at least 4.23 mm (0.166 inch) type. All other
requirements of paragraphs 6(b)(ii) (A) and (B) of this section shall
apply to these bags.
(7) Fireworks devices. Because of the special hazards presented by
fireworks devices if not used in a certain manner, the following listed
fireworks devices shall be labeled as indicated:
(i) Fountains.
Warning (or Caution)
FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive).
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Place on level surface.
Light fuse and get away.
(ii) California candles.
Warning (or Caution) Emits Showers of Sparks
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Hold in hand at bottom of tube.
Point away from body so that neither end points toward body.
(iii) Spike and handle cylindrical fountains.
(A) Spike fountains.
Warning (or Caution) Emits Showers of Sparks
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Stick firmly in ground in an upright position.
Do not hold in hand.
Light fuse and get away.
(B) Handle fountains.
Warning (or Caution) Emits Showers of Sparks
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Hold in hand--point away from body.
Light fuse.
(iv) Roman Candles.
Warning (or Caution) Shoots Flaming Balls
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Stick butt end in ground.
Do not hold in hand.
Light fuse and get away.
(v) Rockets with sticks.
Warning (or Caution) Flammable
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Place in wooden trough or iron pipe at 75 deg. angle, pointing away from
people or flammable material.
Do not hold in hand.
Light fuse and get away.
(vi) Wheels.
Warning (or Caution) Flammable (or Emits Showers of Sparks, if More
Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Attach securely by means of a nail through the hole (or place on hard
flat surface, for ground spinners).
Light fuse and get away.
(vii) Illuminating torches.
Warning (or Caution) Flammable (or Emits Showers of Sparks, if More
Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Hold in hand--point away from body, clothing, or other flammable
material (or place upright on level ground. Do not hold in hand, if more
descriptive).
Light fuse (or light fuse and get away, if more descriptive).
(viii) Sparklers.
On the front and back panels:
Warning (or Caution) Flammable
On the side, front, back, top, or bottom panel.
[[Page 416]]
Caution
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Do not touch glowing wire (or do not touch hot plastic, wood, etc., if
more descriptive).
Hold in hand with arm extended away from body.
Keep burning end or sparks away from wearing apparel or other flammable
material.
(ix) Mines and shells.
Warning (or Caution) Emits Showers of Sparks (or Shoots Flaming Balls,
if More Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Place on hard smooth surface (or place upright on level ground, if more
descriptive).
Do not hold in hand.
Light fuse and get away.
(x) Whistles without report.
Warning (or Caution) Flammable
SHOOTS WHISTLE IN AIR (if applicable)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Do not hold in hand.
Light fuse and get away.
(xi) Toy smoke devices and flitter devices.
Warning (or Caution) Flammable (or Emits Showers of Sparks, if More
Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Do not hold in hand.
Light fuse and get away.
(xii) Helicopter-type rockets.
Warning (or Caution) Flammable (or Emits Showers of Sparks, if More
Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Place on hard, open surface.
Light fuse and get away.
(xiii) Party poppers.
Warning (or Caution) Flammable
Use only under [close] adult supervision. (Use of the word close is
optional.)
Do not point either end toward face or other person.
Hold in hand--jerk string.
(xiv) Missile-type rockets.
Warning (or Caution) Flammable (or Emits Showers of Sparks, if More
Descriptive)
Use only under [close] adult supervision. (Use of the word close is
optional.)
For outdoor use only.
Place on hard, open surface.
Light fuse and get away.
(xv) Labeling--General. Any fireworks device not required to have a
specific label as indicated above shall carry a warning label indicating
to the user where and how the item is to be used and necessary safety
precautions to be observed. All labels required under this section shall
comply with the requirements of Sec. 1500.121 of these regulations. (See
also Sec. 1500.17(a) (3), (8) and (9); Sec. 1500.83(a)(27);
Sec. 1500.85(a)(2); and part 1507).
(8) Art materials.
Note: The Labeling of Hazardous Art Materials Act (``LHAMA''), 15
U.S.C. 1277 (Pub. L. 100-695, enacted November 18, 1988) provides that,
as of November 18, 1990, ``the requirements for the labeling of art
materials set forth in the version of the standard of the American
Society for Testing and Materials [``ASTM''] designated D-4236 that is
in effect on [November 18, 1988] * * * shall be deemed to be a
regulation issued by the Commission under section 3(b)'' of the Federal
Hazardous Substances Act, 15 U.S.C. 1262(b). For the convenience of
interested persons, the Commission is including the requirements of ASTM
D-4236 in paragraph (b)(8)(i) of this section, along with other
requirements (stated in paragraph (b)(8)(ii) of this section) made
applicable to art materials by the LHAMA. The substance of the
requirements specified in LHAMA became effective on November 18, 1990,
as mandated by Congress.
(i) ASTM D-4236--(A) Scope.--(1) This section 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 section 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
paragraph (b)(8)(i)(B)(11) of this section) has the potential to produce
a chronic adverse health effect(s).
(2) This section applies exclusively to art materials packaged in
sizes intended for individual users of any age or those participating in
a small group.
(3) Labeling determinations shall consider reasonably foreseeable
use or misuse.
[[Page 417]]
(4) Manufacturers or repackagers may wish to have compliance
certified by a certifying organization. Guidelines for a certifying
organization are given in paragraph (b)(8)(i)(H) of this section.
(B) Descriptions of Terms Specific to This Standard. (1) Art
material or art material product--any raw or processed material, or
manufactured product, marketed or represented by the producer or
repackager as intended for and suitable for users as defined herein.
(2) Users--artists or crafts people of any age who create, or
recreate in a limited number, largely by hand, works which may or may
not have a practical use, but in which aesthetic considerations are
paramount.
(3) Chronic adverse health effect(s)--a persistent toxic effect(s)
that develops over time from a single, prolonged, or repeated exposure
to a substance. This effect may result from exposure(s) to a substance
that can, in humans, cause sterility, birth defects, harm to a
developing fetus or to a nursing infant, cancer, allergenic
sensitization, damage to the nervous system, or a persistent adverse
effect to any other organ system.
(4) chronic health hazard(s) (hereafter referred to as ``chronic
hazard'')--a health risk to humans, resultant from exposure to a
substance that may cause a chronic adverse health effect.
(5) Analytical laboratory--a laboratory having personnel and
apparatus capable of performing quantitative or qualitative analyses of
art materials, which may yield information that is used by a
toxicologist for evaluation of potentially hazardous materials.
(6) Label--a display of written, printed, or graphic matter upon the
immediate container of any art material product. When the product is
unpackaged, or is not packaged in an immediate container intended or
suitable for delivery to users, the label can be a display of such
matter directly upon the article involved or upon a tag or other
suitable labeling device attached to the art material.
(7) Producer--the person or entity who manufactures, processes, or
imports an art material.
(8) Repackager--the person or entity who obtains materials from
producers and without making changes in such materials puts them in
containers intended for sale as art materials to users.
(9) Sensitizer--a substance known to cause, through an allergic
process, a chronic adverse health effect which becomes evident in a
significant number of people on re-exposure to the same substance.
(10) Toxic--applies to any substance that is likely to produce
personal injury or illness to humans through ingestion, inhalation, or
skin contact.
(11) Toxicologist--an individual who through education, training,
and experience has expertise in the field of toxicology, as it relates
to human exposure, and is either a toxicologist or physician certified
by a nationally recognized certification board.
(12) Bioavailability--the extent that a substance can be absorbed in
a biologically active form.
(C) Requirements. (1) The producer or repackager of art materials
shall submit art material product formulation(s) or reformulation(s) to
a toxicologist for review, such review to be in accordance with
paragraph (b)(8)(l)(D) of this section. The toxicologist shall be
required to keep product formulation(s) confidential.
(2) Unless otherwise agreed in writing by the producer or
repackager, no one other than the toxicologists shall have access to the
formulation(s); except that the toxicologists shall furnish a patient's
physician, on a confidential basis, the information necessary to
diagnose or treat cases of exposure or accidental ingestion.
(3) The producer or repackager, upon advice given by a toxicologist
in accordance with paragraph (b)(8)(i)(D) of this section and based upon
generally accepted, well-established evidence that a component
substance(s) is known to cause chronic adverse health effects adopt
precautionary labeling in accordance with paragraph (b)(8)(i)(E) of this
section.
(4) Labeling shall conform to any labeling practices prescribed by
federal and state statutes or regulations and shall not diminish the
effect of required acute toxicity warnings.
(5) The producer or repackager shall supply a poison exposure
management
[[Page 418]]
information source the generic formulation information required for
dissemination to poison control centers or shall provide a 24-hour cost-
free telephone number to poison control centers.
(6) The producer or repackager shall have a toxicologist review as
necessary, but at least every 5 years, art material product
formulation(s) and associated label(s) based upon the then-current,
generally accepted, well-established scientific knowledge.
(7) Statement of Conformance--``Conforms to ASTM Practice D-4236,''
or ``Conforms to ASTM D-4236,'' or ``Conforms to the health requirements
of ASTM D-4236.'' This statement may be combined with other conformance
statements. The conformance statement should appear whenever practical
on the product; however, it shall also be acceptable to place the
statement on one or more of the following:
(i) The individual product package,
(ii) a display or sign at the point of purchase,
(iii) separate explanatory literature available on requirements at
the point of purchase,
(iv) a response to a formal request for bid or proposal.
(D) Determination of Labeling. (1) An art material is considered to
have the potential for producing chronic adverse health effects if any
customary or reasonably foreseeable use can result in a chronic hazard.
(2) In making the determination, a toxicologist(s) shall take into
account the following:
(i) Current chemical composition of the art material, supplied by an
analytical laboratory or by an industrial chemist on behalf of a
manufacturer or repackager.
(ii) Current generally accepted, well-established scientific
knowledge of the chronic toxic potential of each component and the total
formulation.
(iii) Specific physical and chemical form of the art material
product, bioavailability, concentration, and the amount of each
potentially chronic toxic component found in the formulation.
(iv) Reasonably foreseeable uses of the art material product as
determined by consultation with users and other individuals who are
experienced in use of the material(s), such as teachers, or by market
studies, unless such use information has previously been determined with
respect to the specific art material(s) under review.
(v) Potential for known synergism and antagonism of the various
components of the formulation.
(vi) Potentially chronic adverse health effects of decomposition or
combustion products, if known, from any reasonably foreseeable use of
the hazardous art material product.
(vii) Opinions of various regulatory agencies and scientific bodies,
including the International Agency for Research on Cancer and the
National Cancer Institute, on the potential for chronic adverse health
effects of the various components of the formulation.
(3) Based upon the conclusion reached in conformance with review
determinations set forth herein, the toxicologist(s) shall recommend
precautionary labeling consistent with paragraph (b)(8)(i)(E) of this
section.
(E) Labeling Practices--(1) Signal Word. (i) When a signal word for
an acute hazard(s) is mandated and a chronic hazard(s) exists, the
signal word shall be that for the acute hazard.
(ii) When only a chronic hazard(s) exists, the signal word WARNING
shall be used.
(iii) The signal word shall be prominently visible and set in bold
capitals in a size equal to or greater than the statement of potential
chronic hazards.
(2) List of Potentially Chronic Hazards--Potentially chronic
hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of
this section, shall be stated substantially in accordance with the
statements listed in paragraph (b)(8)(i)(F) of this section. Potentially
chronic hazards noted shall be those that are clinically significant and
that might be expected with any reasonably foreseeable use of the art
material. The hazards should be grouped in the order of relative
descending severity.
(3) Name of Chronically Hazardous Component(s)--All components and
known decomposition products of the formulation with a potential for
chronic hazards, as determined under the procedures of paragraph
(b)(8)(i)(D) of
[[Page 419]]
this section, shall be listed prominently. Generically equivalent names
may be used.
(4) Safe Handling Instructions--Appropriate precautionary statements
as to work practices, personal protection, and ventilation requirements
shall be used substantially conforming with those listed in paragraph
(b)(8)(i)(G) of this section.
(5) List of Sensitizing Components--To protect users from known
sensitizers found within art materials, each label shall contain a list
of those sensitizers present in sufficient amounts to contribute
significantly to a known skin or respiratory sensitization.
(6) Combined Statement--If an art material contains more than one
component capable of causing a chronic adverse health effect, or if a
single chemical can cause several different chronic adverse health
effects, the potential effects may be combined into one statement.
(7) Information Sources--The precautionary label shall contain a
statement identifying a source for additional health information
substantially in conformance with one of the phrases listed below:
(i) For more health information--(24 hour cost-free U.S. telephone
number),
(ii) Contact a physician for more health information, or
(iii) Call your local poison control center for more health
information.
(8) Labeling Content, Product Size--Any art material product in a
container larger in size than one fluid ounce (30 ml) (if the product is
sold by volume) or one ounce net weight (28 g) (if the product is sold
by weight) shall have full precautionary labeling, as described in
paragraph (b)(8)(i) (E) of this section. Any art material product in a
container equal to or smaller than one fluid ounce or one ounce net
weight shall have a label that includes a signal word in conformance
with paragraph (b)(8)(i)(E)(1) of this section and a list of potentially
harmful or sensitizing components in conformance with paragraphs
(b)(8)(i)(E) (3) and (5) of this section.
(9) The information described in paragraph (b)(8)(i)(E) of this
section must appear on:
(i) The outside container or wrapper, if any, unless it is easily
legible through the outside container or wrapper and
(ii) All accompanying literature where there are directions for use,
written or otherwise. Where a product that requires warning labels under
paragraphs (b)(8)(i) (D) and (E) of this section is packed within a
point-of-sale package that obscures the warning statement(s), the point-
of-sale package shall carry the signal word conforming to paragraph
(b)(8)(i)(E)(1) and the following wording: ``Contains: (list hazardous
product(s)) that may be harmful if misused. Read cautions on individual
containers carefully. Keep out of the reach of children.''
(10) Statements required under paragraphs (b)(8)(i) (D) and (E) of
this section must be in the English language and located prominently in
conspicuous and legible type in contrast by topography, layout, or color
with other printed matter on the label.
(11) Supplemental Information--Where appropriate, more detailed
information that relates to chronic hazard(s), such as physical
properties, decomposition products, detailed safety instructions, or
disposal recommendations, shall be included in supplemental documents,
such as Material Safety Data Sheets, technical brochures, technical data
sheets etc.
(F) chronic Hazard Statements
MAY CAUSE STERILITY.
CONTACT MAY CAUSE PERMANENT EYE DAMAGE.
MAY BE HARMFUL BY BREATHING VAPORS/DUSTS.
MAY BE HARMFUL IF SWALLOWED.
MAY BE HARMFUL BY SKIN CONTACT.
MAY PRODUCE BIRTH DEFECTS IN THE DEVELOPING FETUS.
MAY BE EXCRETED IN HUMAN MILK.
MAY CAUSE HARM TO THE NURSING INFANT.
CANCER AGENT! EXPOSURE MAY PRODUCE CANCER.
CANCER AGENT BASED ON TESTS WITH LABORATORY ANIMALS.
POSSIBLE CANCER AGENT BASED ON TESTS WITH LABORATORY ANIMALS.
[[Page 420]]
MAY PRODUCE ALLERGIC REACTION BY INGESTION/INHALATION/SKIN CONTACT.
MAY PRODUCE NUMBNESS OR WEAKNESS IN THE EXTREMITIES.
EXPOSURE MAY CAUSE (SPECIFY THE ORGAN(S)) DAMAGE.
HEATING/COMBUSTION MAY CAUSE HAZARDOUS DECOMPOSITION PRODUCTS.
(G) Precautionary Statements
Keep out of reach of children.
When using do not eat, drink, or smoke.
Wash hands immediately after use.
Avoid inhalation/ingestion/skin contact.
Avoid fumes from combustion.
Keep container tightly closed when not in use.
Store in well-ventilated area.
Wear protective clothing (specify type).
Wear protective goggles/face shield.
Wear NIOSH-certified mask for dusts/mists/fumes.
Wear NIOSH-certified respirator with an appropriate cartridge for
(specify).
Wear NIOSH-certified supplied-air respirator.
Use window exhaust fan to remove vapors and ensure adequate cross
ventilation. (Specify explosion-proof if necessary.)
Do not heat above (specify temperature) without adequate ventilation.
Use (specify type) local exhausting hood.
Do not use/mix with (specify material).
(ii) The following shall apply with respect to the standard for art
materials set forth in Sec. 1500.14(b)(8)(i).
(A) The term art material or art material product shall mean any
substance marketed or represented by the producer or repackager as
suitable for use in any phase of the creation of any work of visual or
graphic art of any medium. The term does not include economic poisons
subject to the Federal Insecticide, Fungicide, and Rodenticide Act or
drugs, devices, or cosmetics subject to the Federal Food, Drug, and
Cosmetics Act.
(B) The standard referred to in paragraph (b)(8)(i) of this section
applies to art materials intended for users of any age.
(C) Each producer or repackager of art materials shall describe in
writing the criteria used to determine whether an art material has the
potential for producing chronic adverse health effects. Each producer or
repackager shall submit, to the Commission's Division of Regulatory
Management, Consumer Product Safety Commission, Washington, DC 20207,
the written description of the criteria described above and a list of
art materials that require hazard warning labels under this section.
Upon request of the Commission, a producer or repackager shall submit to
the Commission product formulations.
(D) All art materials that require chronic hazard labeling pursuant
to this section must include on the label the name and United States
address of the producer or repackager of the art materials, an
appropriate United States telephone number that can be contacted for
more information on the hazards requiring warning labels under this
section, and a statement that such art materials are inappropriate for
use by children.
(E) If an art material producer or repackager becomes newly aware of
any significant information regarding the hazards of an art material or
ways to protect against the hazard, this new information must be
incorporated into the labels of such art materials that are manufactured
after 12 months from the date of discovery. If a producer or repackager
reformulates an art material, the new formulation must be evaluated and
labeled in accordance with the standard set forth Sec. 1500.14(b)(8)(i).
(F) In determining whether an art material has the potential for
producing chronic adverse health effects, including carcinogenicity and
potential carcinogenicity, the toxicologist to whom the substance is
referred under the standard described above shall take into account
opinions of various regulatory agencies and scientific bodies, including
the U.S. Consumer Product Safety Commission (CPSC), the U.S.
Environmental Protection Agency (EPA), and the International Agency for
Research on Cancer (IARC).
(iii) Pursuant to the LHAMA, the Commission has issued guidelines
which, where possible, specify criteria
[[Page 421]]
for determining when any customary or reasonably foreseeable use of an
art material can result in a chronic hazard. These guidelines include
criteria for determining when art materials may produce chronic adverse
effects in children and adults, criteria for determining which
substances contained in art materials have the potential for producing
chronic adverse effects and what those effects are, criteria for
determining the bioavailability of chronically hazardous substances
contained in art materials when the products are used in a customary or
reasonably foreseeable manner, and criteria for determining acceptable
daily intake levels for chronically hazardous substances contained in
art materials. Because these guidelines apply to hazardous substances in
general as well as to hazardous substances in art materials, the
guidelines are set forth in Sec. 1500.135 and a definition of ``chronic
toxicity'' is provided in Sec. 1500.3(c)(2)(ii) as part of
supplementation of the term ``toxic'' in section 2(q) of the FHSA.
(iv) Policies and interpretations.
(A) For purposes of enforcement policy, the Commission will not
consider as sufficient grounds for bringing an enforcement action under
the Labeling of Hazardous Art Materials Act (``LHAMA'') the failure of
the following types of products to meet the requirements of
Sec. 1500.14(b)(8) (i) through (iii).
(1) Products whose intended general use is not to create art (e.g.,
common wood pencils, and single colored pens, markers, and chalk),
unless the particular product is specifically packaged, promoted, or
marketed in a manner that would lead a reasonable person to conclude
that it is intended for use as an art material. Factors the Commission
would consider in making this determination are how an item is packaged
(e.g., packages of multiple colored pencils, chalks, or markers unless
promoted for non-art materials uses are likely to be art materials), how
it is marketed and promoted (e.g., pencils and pens intended
specifically for sketching and drawing are likely to be art materials),
and where it is sold (e.g., products sold in an art supply store are
likely to be art materials). The products described in this paragraph do
not meet the statutory definition of ``art material.''
(2) Tools, implements, and furniture used in the creation of a work
of art such as brushes, chisels, easels, picture frames, drafting tables
and chairs, canvas stretchers, potter's wheels, hammers, air pumps for
air brushes, kilns, and molds.
(3) Surface materials upon which an art material is applied, such as
coloring books and canvas, unless, as a result of processing or
handling, the consumer is likely to be exposed to a chemical in or on
the surface material in a manner which makes that chemical susceptible
to being ingested, absorbed, or inhaled.
(4) The following materials whether used as a surface or applied to
one, unless, as a result of processing or handling, the consumer is
likely to be exposed to a chemical in or on the surface material in a
manner which makes that chemical susceptible to being ingested,
absorbed, or inhaled: paper, cloth, plastics, films, yarn, threads,
rubber, sand, wood, stone, tile, masonry, and metal.
(B) For purposes of LHAMA enforcement policy, the Commission will
enforce against materials including, but not limited to, paints,
crayons, colored pencils, glues, adhesives, and putties, if such
materials are sold as part of an art, craft, model, or hobby kit. The
Commission will enforce the LHAMA requirements against paints or other
materials sold separately which are intended to decorate art, craft,
model, and hobby items. Adhesives, glues, and putties intended for
general repair or construction uses are not subject to LHAMA. However,
the Commission will enforce the LHAMA requirements against adhesives,
glues, and putties sold separately (not part of a kit) if they are
intended for art and craft and model construction uses. This paragraph
(b)(8)(iv)(B) applies to products introduced into interstate commerce on
or after August 14, 1995.
(C) Commission regulations at Sec. 1500.14(b)(8)(i)(C)(7) require
that a statement of conformance appear with art materials that have been
reviewed in accordance with the Commission standard. The Commission
interprets this provision to require a conformance
[[Page 422]]
statement regardless of the presence of any chronic hazard warnings.
(D) Nothing in this enforcement statement should be deemed to alter
any of the requirements of the Federal Hazardous Substances Act
(``FHSA''), such as, but not limited to, the requirement that any
hazardous substance intended or packaged in a form suitable for
household use must be labeled in accordance with section 2(p) of the
FHSA.
Appendix A to Sec. 1500.14(b)(8)--Guidelines for a Certifying
Organization (Not Mandatory)
(a) The term ``certifying organization,'' as used in this paragraph,
refers to an organization or an institute that, after assuring that all
provisions are met, certifies that an art material does conform to the
labeling requirements of this practice.
(b) The certifying body may be funded by member manufacturers, but
should include users or their representatives, as well as manufacturers'
chemists, on its technical and certifying committees.
(c) Representative samples of art materials, labeled as conforming
to this section and bought at retail, should be analyzed at random and
from time to time by an analytical laboratory to ensure they are the
same as the formulation used by the toxicologist(s) for determining
labeling requirements.
(d) The methods used by the toxicologist(s) in review and
determination of the need and content of precautionary labeling for
potentially chronic adverse health effects should be periodically
reviewed by an advisory board composed of not less than three or more
than five toxicologists, at least one of whom is certified in toxicology
by a nationally recognized certification board.
(e) In cases where there is disagreement by participating producers
or participating users, with the determination of the toxicologist(s),
there should be a method whereby the toxicologist's decision can be
presented to the advisory board of toxicologists for arbitration.
[38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22934, June 8, 1976;
48 FR 16, Jan. 3, 1983; 53 FR 3018, Feb. 3, 1988; 57 FR 46669, Oct. 9,
1992; 60 FR 8193, Feb. 27, 1995; 61 FR 19829, May 3, 1996; 61 FR 33175,
June 26, 1996]
Sec. 1500.15 Labeling of fire extinguishers.
When a substance or mixture of substances labeled for use in or as a
fire extinguisher produces substances that are toxic within the meaning
of Sec. 1500.3(c) (1) and (2) when used according to label directions to
extinguish a fire, the containers for such substances shall bear the
following labeling:
(a) When substances are produced that meet the definition of highly
toxic in Sec. 1500.3(c)(1), the signal word ``Danger'' and the statement
of hazard ``Poisonous gases formed when used to extinguish flame or on
contact with heat'' are required labeling.
(b) When substances are produced that meet the definition of toxic
in Sec. 1500.3(c)(2), the signal word ``Caution'' or ``Warning'' and the
statement of hazard ``Dangerous gas formed when used to extinguish flame
or on contact with heat'' are required labeling.
(c) Regardless of whether paragraph (a) or (b) of this section
applies, any substance or mixture of substances labeled for use as a
fire extinguisher that, if applied to an electrical fire, would subject
the user to the likelihood of electrical shock shall be conspicuously
labeled ``Caution: Do not use on electrical wires.''
(d) The statements specified in paragraphs (a), (b), and (c) of this
section shall be in addition to any other that may be required under the
act. All such substances or mixtures of substances shall also bear the
additional statements ``Use in an enclosed place may be fatal'' and ``Do
not enter area until well ventilated and all odor of chemical has
disappeared.''
Sec. 1500.17 Banned hazardous substances.
(a) Under the authority of section 2(q)(1)(B) of the act, the
Commission declares as banned hazardous substances the following
articles because they possess such a degree or nature of hazard that
adequate cautionary labeling cannot be written and the public health and
safety can be served only by keeping such articles out of interstate
commerce:
(1) Mixtures that are intended primarily for application to interior
masonry walls, floors, etc., as a water repellant treatment and that are
``extremely flammable'' within the meaning of section 2(1) of the act
(repeated in Sec. 1500.3(b)(10)).
(2) Carbon tetrachloride and mixtures containing it (including
carbon tetrachloride and mixtures containing it
[[Page 423]]
used in fire extinguishers), excluding unavoidable manufacturing
residues of carbon tetrachloride in other chemicals that under
reasonably foreseeable conditions of use do not result in an atmospheric
concentration of carbon tetrachloride greater than 10 parts per million.
(3) Fireworks devices intended to produce audible effects (including
but not limited to cherry bombs, M-80 salutes, silver salutes, and other
large firecrackers, aerial bombs, and other fireworks designed to
produce audible effects, and including kits and components intended to
produce such fireworks) if the audible effect is produced by a charge of
more than 2 grains of pyrotechnic composition; except that this
provision shall not apply to such fireworks devices if all of the
following conditions are met:
(i) Such fireworks devices are distributed to farmers, ranchers, or
growers through a wildlife management program administered by the U.S.
Department of the Interior (or by equivalent State or local government
agencies); and
(ii) Such distribution is in response to a written application
describing the wildlife management problem that requires use of such
devices, is of a quantity no greater than required to control the
problem described, and is where other means of control are unavailable
or inadequate. (See also Sec. 1500.14(b)(7); Sec. 1500.17(a) (8) and
(9); Sec. 1500.83(a)(27); Sec. 1500.85(a)(2); and part 1507).
(4) Liquid drain cleaners containing 10 percent or more by weight of
sodium and/or potassium hydroxide; except that this subparagraph shall
not apply to such liquid drain cleaners if packaged in accordance with a
standard for special packaging of such articles promulgated under the
Poison Prevention Packaging Act of 1970 (Pub. L. 91-601, 84 Stat. 1670-
74 (15 U.S.C. 1471-76)).
(5) Products containing soluble cyanide salts, excluding unavoidable
manufacturing residues of cyanide salts in other chemicals that under
reasonable and foreseeable conditions of use will not result in a
concentration of cyanide greater than 25 parts per million.
(6)(i) Any paint or other similar surface-coating material intended,
or packaged in a form suitable, for use in or around the household that:
(A) Is shipped in interstate commerce after December 31, 1973, and
contains lead compounds of which the lead content (calculated as the
metal) is in excess of 0.06 percent of the total weight of the contained
solids or dried paint film; or
(B) Is shipped in interstate commerce after December 31, 1972, and
contains lead compounds of which the lead content (calculated as the
metal) is in excess of 0.5 percent of the total weight of the contained
solids or dried paint film.
(C) [Reserved]
(D) The provisions of paragraph (a)(6)(i) of this section do not
apply to artists' paints and related materials.
(ii) Any toy or other article intended for use by children that:
(A) Is shipped in interstate commerce after December 31, 1973, and
bears any paint or other similar surface-coating material containing
lead compounds of which the lead content (calculated as the metal) is in
excess of 0.06 percent of the total weight of the contained solids or
dried paint film; or
(B) Is shipped in interstate commerce after December 31, 1972, and
bears any paint or other similar surface-coating material containing
lead compounds of which the lead content (calculated as the metal) is in
excess of 0.5 percent of the total weight of the contained solids or
dried paint film.
(iii) Since the Commission has issued comprehensive regulations for
lead-containing paint and certain consumer products bearing such paint
at the 0.06 percent level under the Consumer Product Safety Act (see 16
CFR part 1303), paragraphs (i) and (ii) of Sec. 1500.17(a)(6) are
revoked as to the subject products manufactured after February 27, 1978.
Note: The effective date of paragraphs (a)(6)(i)(A) and
(a)(6)(ii)(A) was stayed by an order published in the Federal Register
of August 10, 1972 (37 FR 16078).
(7) General-use garments containing asbestos (other than garments
having a bona fide application for personal protection against thermal
injury and so constructed that the asbestos fibers will not become
airborne under reasonably foreseeable conditions of use).
[[Page 424]]
(8) Firecrackers designed to produce audible effects, if the audible
effect is produced by a charge of more than 50 milligrams (.772 grains)
of pyrotechnic composition (not including firecrackers included as
components of a rocket), aerial bombs, and devices that may be confused
with candy or other foods, such as ``dragon eggs,'' and ``cracker
balls'' (also known as ``ball-type caps''), and including kits and
components intended to produce such fireworks except such devices which
meet all of the following conditions:
(i) The fireworks devices are distributed to farmers, ranchers, or
growers through a wildlife management program administered by the U.S.
Department of Interior (or by equivalent State or local governmental
agencies); and
(ii) Such distribution is in response to a written application
describing the wildlife management problem that requires use of such
devices, is of a quantity no greater than required to control the
problem described, and is where other means of control is unavailable or
inadequate. (See also Sec. 1500.17(a) (3) and (9)).
(9) All fireworks devices, other than firecrackers, including kits
and components intended to produce such fireworks, not otherwise banned
under the act, that do not comply with the applicable requirements of
part 1507 of this chapter, except fireworks devices which meet all the
following conditions:
(i) The fireworks devices are distributed to farmers, ranchers, or
growers through a wildlife management program administered by the U.S.
Department of the Interior (or by equivalent State or local government
agencies); and
(ii) Such distribution is in response to a written application
describing the wildlife management problem that requires use of such
devices, is of a quantity no greater than required to control the
problem described, and is where other means of control is unavailable or
inadequate. (See also Sec. 1500.17(a) (3) and (8)).
(10) Self-pressurized products intended or suitable for household
use that contain vinyl chloride monomer as an ingredient or in the
propellant manufactured or imported on or after October 7, 1974. (See
also Sec. 1500.17(a) (3) and (8)).
(11)(i) Reloadable tube aerial shell fireworks devices that use
shells larger than 1.75 inches in outer diameter and that are imported
on or after October 8, 1991.
(ii) Findings. (A) General. In order to issue a rule under section
2(q)(1) of the Federal Hazardous Substances Act (``FHSA''), 15 U.S.C.
1261(q)(1), classifying a substance or article as a banned hazardous
substance, the FHSA requires the Commission to make certain findings and
to include these findings in the regulation. These findings are
discussed below.
(B) Voluntary standard. Although a voluntary standard relating to
the risk of injury associated with reloadable tube aerial shells has
been adopted, it has not been implemented. Thus, the Commission is not
required to make findings covering the likelihood that the voluntary
standard would result in elimination or adequate reduction of the risk
of injury or that there would be substantial compliance with the
voluntary standard.
(C) Relationship of benefits to costs. The Commission estimates that
the removal of large reloadable shells from the market is likely to
virtually eliminate the number of associated injuries, with only a
slight offsetting increase in the number of injuries due to the use of
substitute Class C fireworks products available to consumers. The
estimated net benefits range from essentially zero to close to $1
million annually. The annual costs of a ban are estimated to be very
low. Included are potential costs to foreign manufacturers and U.S.
importers from sales losses, production changes, and inventory
retrofitting, and slightly reduced market choices for consumers who
purchase aerial display fireworks. Costs to each of these sectors are
estimated to be slight, and are reduced to the extent that alternative
products are perceived as adequate substitutes for large reloadable
shells. Thus, the Commission finds that the benefits expected from the
regulation bear a reasonable relationship to its costs.
[[Page 425]]
(D) Least burdensome requirement. The Commission considered several
alternatives to the ban. These included: Design or performance criteria;
additional or alternative labeling; inclusion of some reloadable shells
1.75 inches or smaller in the ban; and no action in reliance on the
voluntary standard. The Commission determined that a ban of reloadable
shells larger than 1.75 inches in outer diameter is the least burdensome
alternative that would prevent or adequately reduce the risk of injury.
(1) Regarding design or performance criteria, the Commission
considered requirements similar to those stated in the voluntary
standard of the American Fireworks Standards Laboratory (``AFSL'').
However, such criteria may increase the cost of the product and would
not address all factors involved in the incidents. Further, concerns
exist about the feasibility of criteria and quality control.
(2) Regarding additional or alternative labeling, the users'
perception and experience concerning the amount of time available to get
away may lead them to disregard an inconsistent warning. There are no
data to suggest that a significant number, if any, incidents would be
avoided if large reloadable shells carried more detailed labels or
instructions than they currently do. It cannot be concluded that
potential benefits would be greater than zero.
(3) The Commission considered including reloadable shells that are
1.75 inches or less in outer diameter and have the ``equivalent
explosive power'' of larger shells. A kinetic energy level of 70 joules
was considered to evaluate explosive power. However, any potential
benefits are uncertain since the Commission concluded that a clear
relation between kinetic energy and injury potential could not be
established. Also, costs could be slightly higher.
(4) The Commission also considered imposing no mandatory
requirements on large reloadable shells and relying instead on the AFSL
voluntary standard. However, it is uncertain whether any net benefits to
consumers would result from this alternative, since the level of injury
reduction could be near zero if, as is probable, some firms chose not to
conform with some or all of the AFSL standard.
(12)(i) Large multiple-tube devices. Multiple-tube mine and shell
fireworks devices that first enter commerce or are imported on or after
March 26, 1997, that have any tube measuring 1.5 inches (3.8 cm) or more
in inner diameter, and that have a minimum tip angle less than 60
degrees when tested in accordance with the procedure of Sec. 1507.12 of
this part.
(ii) Findings--(A) General. In order to issue a rule under the
section 2(q)(1) of the FHSA, 15 U.S.C. 1261(q)(1), classifying a
substance or article as a banned hazardous substance, the FHSA requires
the Commission to make certain findings and to include these in the
regulation. These findings are discussed in paragraphs (a)(12)(ii) (B)
through (D) of this section.
(B) Voluntary standard. (1) One alternative to the tip-angle
requirement that the Commission considered is to take no mandatory
action, and to depend on a voluntary standard. The American Fireworks
Safety Laboratory (AFSL) has a standard for mines and shells intended to
address the potential tip-over hazard associated with multiple-tube
fireworks devices. AFSL's Voluntary Standard for Mines and Shells--
Single or Multiple Shot requires that large multiple-tube devices not
tip over (except as the result of the last shot) when shot on a 2-inch
thick medium-density foam pad. The Commission cannot conclude that
AFSL's existing voluntary standard adequately reduces the risk of injury
from large devices that tip over while functioning. The Commission's
tests using polyurethane foam did not find sufficient agreement between
performance on foam and on grass. No other data are available to show
that this dynamic test is reliable.
(2) In addition, even if the AFSL standard is effective, the
Commission does not believe that compliance with the standard will be
adequate. AFSL reports that it has been testing in accordance with its
standard since January 1994. However, the results of CPSC's compliance
testing indicate that multiple-tube devices still tip over while
functioning. In fiscal year
[[Page 426]]
1994, all 24 imported devices the Commission tested, and 1 of 8 domestic
devices, tipped over while functioning. In fiscal year 1995, 22 of 27
imported devices and 1 of 5 domestic devices tipped over during
Commission testing. The Commission finds that there is unlikely to be
substantial compliance with the voluntary standard applicable to
multiple-tube devices.
(C) Relationship of benefits to costs. The Commission estimates that
the 60-degree tip-angle standard will eliminate the unreasonable tip-
over risk posed by these devices. This will provide benefits of saving
one life about every 3 years, and preventing an unknown number of
nonfatal injuries. The annual cost of modifying affected devices is
estimated to be between $1.5 million and $2.7 million. The Commission
finds that the benefits from the regulation bear a reasonable
relationship to its costs.
(D) Least burdensome requirement. The Commission considered the
following alternatives: a ban of all multiple-tube devices with inner
tube diameters 1.5 inches or greater; a dynamic performance standard;
additional labeling requirements; and relying on the voluntary standard.
Although a ban of all large multiple-tube devices would address the risk
of injury, it would be more burdensome than the tip-angle standard. The
Commission was unable to develop a satisfactory dynamic standard that
would reduce the risk of injury. Neither additional labeling
requirements nor reliance on the voluntary standard would adequately
reduce the risk of injury. Thus, the Commission finds that a standard
requiring large multiple-tube devices to have a minimum tip angle
greater than 60 degrees is the least burdensome requirement that would
prevent or adequately reduce the risk of injury.
(Secs. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74 Stat. 372, 374, as
amended 80 Stat. 1304-05, 83 Stat. 187-189, 90 Stat. 503 (15 U.S.C.
1261, 1262); sec. 701 (e), (f), (g), 52 Stat. 1055-56, as amended 70
Stat. 919, 72 Stat. 948 (21 U.S.C. 371 (e), (f), (g)), sec. 30(a), 86
Stat. 1231 (15 U.S.C. 2079(a)))
[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 27514, Oct. 4, 1973;
38 FR 31520, Nov. 15, 1973; 39 FR 30114, Aug. 21, 1974; 39 FR 42903,
Dec. 9, 1974; 41 FR 22935, June 8, 1976; 42 FR 44202, Sept. 1, 1977; 43
FR 12310, Mar. 24, 1978; 48 FR 16, Jan. 3, 1983; 56 FR 37837, Aug. 9,
1991; 61 FR 13095, Mar. 26, 1996; 61 FR 18245, Apr. 25, 1996]
Sec. 1500.18 Banned toys and other banned articles intended for use by children.
(a) Toys and other articles presenting mechanical hazards. Under the
authority of sections 2(f)(1)(D) and 24 of the act and pursuant to the
provisions of section 3(e) of the act, the Commission has determined
that the following types of toys or other articles intended for use by
children present a mechanical hazard within the meaning of section 2(s)
of the act because in normal use, or when subjected to reasonably
foreseeable damage or abuse, the design or manufacture presents an
unreasonable risk of personal injury or illness:
(1) Any toy rattle containing, either internally or externally,
rigid wires, sharp protrusions, or loose small objects that have the
potential for causing lacerations, puncture wound injury, aspiration,
ingestion, or other injury. (But see Sec. 1500.86(a)(1)).
(2) Any toy having noisemaking components or attachments capable of
being dislodged by the operating features of the toy or capable of being
deliberately removed by a child, which toy has the potential for causing
laceration, puncture wound injury, aspiration, ingestion, or other
injury.
(3) Any doll, stuffed animal, or other similar toy having internal
or external components that have the potential for
[[Page 427]]
causing laceration, puncture wound injury, or other similar injury. (But
see Sec. 1500.86(a)(2)); (See also Sec. Sec. 1500.48 and 1500.49).
(4) Lawn darts and other similar sharp-pointed toys usually intended
for outdoor use and having the potential for causing puncture wound
injury.
(5) Caps (paper or plastic) intended for use with toy guns and toy
guns not intended for use with caps if such caps when so used or such
toy guns produce impulse-type sound at a peak pressure level at or above
138 decibels, referred to 0.0002 dyne per square centimeter, when
measured in an anechoic chamber at a distance of 25 centimeters (or the
distance at which the sound source ordinarily would be from the ear of
the child using it if such distance is less than 25 centimeters) in any
direction from the source of the sound. This paragraph is an interim
regulation pending further investigation to determine whether prevention
of damage to the hearing of children requires revision hereof.
(6) Any article known as a ``baby-bouncer,'' ``walker-jumper,'' or
``baby-walker'' and any other similar article (referred to in this
paragraph as ``article(s)'') which is intended to support very young
children while sitting walking, bouncing, jumping, and/or reclining, and
which because of its design has any exposed parts capable of causing
amputation, crushing, lacerations, fractures, hematomas, bruises, or
other injuries to fingers, toes, or other parts of the anatomy of young
children. Included among, but not limited to, the design features of
such articles which classify the articles as banned hazardous substances
are:
(i) The areas about the point on each side of the article where the
frame components are joined together to form an ``X'' shape capable of
producing a scissoring, shearing, or pinching effect.
(ii) Other areas where two or more parts are joined in such a manner
as to permit a rotational movement capable of exerting a scissoring,
shearing, or pinching effect.
(iii) Exposed coil springs which may expand sufficiently to allow an
infant's finger, toe, or any other part of the anatomy to be inserted,
in whole or in part, and injured by being caught between the coils of
the spring or between the spring and another part of the article.
(iv) Holes in plates or tubes which provide the possibility of
insertion, in whole or in part, of a finger, toe, or any part of the
anatomy that could then be injured by the movement of another part of
the article.
(v) Design and construction that permits accidental collapse while
in use. (But see Sec. 1500.86(a)(4)).
(7) Toys usually known as clacker balls and consisting of two balls
of plastic or another material connected by a length of line or cord or
similar connector (referred to as ``cord'' in Sec. 1500.86(a)(5)),
intended to be operated in a rhythmic manner by an upward and downward
motion of the hand so that the two balls will meet forcefully at the top
and bottom of two semicircles thus causing a ``clacking'' sound, which
toys present a mechanical hazard because their design or manufacture
presents an unreasonable risk of personal injury from fracture,
fragmentations, or disassembly of the toy and from propulsion of the toy
or its part(s). (But see Sec. 1500.86(a)(5).) This does not include
products that are constructed so that the connecting members consist of
plastic rods integrally molded to the balls and are mounted on a pivot
so that movement of the balls is essentially limited to a single plane.
(8) Any pacifier that does not meet the requirements of 16 CFR part
1511 and that is introduced into interstate commerce after February 26,
1978.
(9) Any toy or other article intended for use by children under 3
years of age which presents a choking, aspiration, or ingestion hazard
because of small parts as determined by part 1501 of this chapter and
which is introduced into interstate commerce after January 1, 1980. For
purposes of this regulation, introduction into interstate commerce is
defined as follows: A toy or children's article manufactured outside the
United States is introduced into interstate commerce when it is first
brought within a U.S. port of entry. A toy or children's article
manufactured in the United States is introduced into interstate commerce
(1) at the time of its first interstate sale, or (2) at the
[[Page 428]]
time of its first intrastate sale if one or more of its components and/
or raw materials were received interstate, whichever occurs earlier.
Part 1501 defines the term ``toy or other article intended for use by
children under 3,'' as used in this regulation, and exempts certain
products from banning under this regulation.
(10)-(11) [Reserved]
(12) Any bicycle as defined in Sec. 1512.2(a) of this chapter
(except a bicycle that is a ``track bicycle'' or a ``one-of-a-kind
bicycle'' as defined in Sec. 1512.2 (d) and (e) of this chapter) that is
introduced into interstate commerce on or after May 11, 1976, and that
does not comply with the requirements of part 1512 of this chapter,
except for Sec. Sec. 1512.5(c)(3), 1512.9(a), 1512.18(e) and 1512.18(f)
which become effective November 13, 1976.
(13) Any full-size baby crib (as defined in Sec. 1508.1(a) of this
chapter) that is introduced into interstate commerce on or after
February 1, 1974, and that does not comply with the requirements of
Sec. Sec. 1508.2 through 1508.10 of this chapter; and any full size baby
crib (as defined in Sec. 1508.1(a) of this chapter) that is manufactured
on or after April 27, 1983, and that does not comply with
Sec. Sec. 1508.2 through 1508.11 of this chapter.
(14) Any non-full-size baby crib (as defined in Sec. 1509.2 of this
chapter) that is introduced into interstate commerce after August 9,
1976, and that does not comply with the requirements of Sec. Sec. 1509.3
through 1509.12 of this chapter; and any non-full size baby crib (as
defined in Sec. 1509.2 of this chapter) that is manufactured on or after
April 27, 1983, and that does not comply with Sec. Sec. 1509.3 through
1509.13 of this chapter.
(15) Any rattle (as defined in Sec. 1510.2 of this chapter) that is
introduced into interstate commerce on or after August 21, 1978, and
that does not comply with the requirements of part 1510 of this chapter.
For purposes of the regulation, introduction into interstate commerce is
defined as follows: A rattle manufactured outside the United States is
introduced into interstate commerce when it is first brought within a
U.S. port of entry. A rattle manufactured in the United States is
introduced into interstate commerce (a) at the time of its first
interstate sale, or (b) at the time of its first intrastate sale if one
or more of its components and/or raw materials were received interstate.
(16)(i) Any article known as an ``infant cushion'' or ``infant
pillow,'' and any other similar article, which has all of the following
characteristics:
(A) Has a flexible fabric covering. The term fabric includes those
materials covered by the definition of ``fabric'' in section 2(f) of the
Flammable Fabrics Act, 15 U.S.C. 1191(f).
(B) Is loosely filled with a granular material, including but not
limited to, polystyrene beads or pellets.
(C) Is easily flattened.
(D) Is capable of conforming to the body or face of an infant.
(E) Is intended or promoted for use by children under one year of
age.
(ii) Findings--(A) General. In order to issue a rule under section
2(q)(1) of the Federal Hazardous Substance Act (FHSA), 15 U.S.C.
1261(q)(1), classifying a substance or article as a banned hazardous
substance, the FHSA requires the Commission to make certain findings and
to include these findings in the regulation. These findings are
discussed in paragraphs (a)(16)(ii) (B) through (D) of this section.
(B) Voluntary standard. No findings concerning compliance with or
adequacy of a voluntary standard are necessary since no voluntary
standard addressing infant cushions has been adopted or implemented.
(C) Relationship of benefits to costs. The Commission estimates that
the removal of infant cushions from the market will result in total
annual benefits of approximately five million dollars. The potential
costs to businesses are expected to be offset by production of other
products, and the potential costs to consumers are likely to be offset
by the availability of substitutes for a comparable price.
(D) Least burdensome requirement. The Commission considered labeling
and a design or performance standard as alternatives to the ban. The
Commission does not believe that any form of labeling would have a
significant effect in preventing the hazard associated with infant
cushions. The Commission also concluded that no feasible standard exists
that would address the hazard.
[[Page 429]]
Thus, the Commission determined that a ban of infant cushions is the
least burdensome alternative that would prevent or adequately reduce the
risk of injury.
(17) Any ball intended for children under three years of age that,
under the influence of its own weight, passes, in any orientation,
entirely through a circular hole with a diameter of 1.75 inches (44.4
mm.) in a rigid template \1/4\ inches (6 mm.) thick. In testing to
evaluate compliance with this paragraph, the diameter of opening in the
Commission's test template shall be no greater than 1.75 inches (44.4
mm.).
(i) For the purposes of this paragraph, the term ``ball'' includes
any spherical, ovoid, or ellipsoidal object that is designed or intended
to be thrown, hit, kicked, rolled, dropped, or bounced. The term
``ball'' includes any spherical, ovoid, or ellipsoidal object that is
attached to a toy or article by means of a string, elastic cord, or
similar tether. The term ``ball'' also includes any multi-sided object
formed by connecting planes into a generally spherical, ovoid, or
ellipsoidal shape that is designated or intended to be used as a ball,
and any novelty item of a generally spherical, ovoid, or ellipsoidal
shape that is designated or intended to be used as a ball.
(ii) The term ``ball'' does not include dice, or balls permanently
enclosed inside pinball machines, mazes, or similar outer containers. A
ball is permanently enclosed if, when tested in accordance with 16 CFR
1500.52, the ball is not removed from the outer container.
(iii) In determining whether such a ball is intended for use by
children under three years of age, the criteria specified in 16 CFR
1501.2(b) and the enforcement procedure established by 16 CFR 1501.5
shall apply.
(18)(i) Any bunk bed (as defined in Sec. 1513.2(c) of this chapter)
that does not comply with the requirements of part 1513 of this chapter.
(ii) Findings. In order to issue a rule under Section 3(e) of the
Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1262(e), classifying
a toy or other article intended for use by children as a hazardous
substance on the basis that it presents a mechanical hazard (as defined
in Section 2(s) of the FHSA), the FHSA requires the Commission to make
the following findings and to include these findings in the regulation:
Bunk beds present a mechanical hazard; Where a voluntary standard has
been adopted and implemented by the affected industry, that compliance
with such voluntary standard is not likely to result in the elimination
or adequate reduction of the risk of injury, or it is unlikely that
there will be substantial compliance with such voluntary standard; The
benefits expected from the rule bear a reasonable relationship to its
costs; and The rule imposes the least burdensome requirement that
prevents or adequately reduces the risk of injury for which the rule is
being promulgated. These findings are made in the Appendix to Part 1513.
(19)(i) Dive sticks, and other similar articles, that are used in
swimming pools or other water environments for such activities as
underwater retrieval games or swimming instruction, and which, when
placed in the water, submerge and rest at the bottom of the pool. This
includes products that are pre-weighted to sink to the bottom and
products that are designed to allow the user to adjust the weight. Dive
sticks and similar articles that come to rest underwater at an angle
greater than 45 degrees from vertical when measured under the test at
Sec. 1500.86(a)(7) and dive sticks and similar articles that maintain a
compressive force of less than 5-lbf under the test at
Sec. 1500.86(a)(8) are exempt from this banning rule. Articles that have
a continuous circular shape, such as dive rings and dive disks are also
exempt.
(ii)(A) Findings. In order for the Commission to issue a rule under
section 2(q)(1) of the FHSA classifying a substance or article as a
banned hazardous substance, the Commission must make certain findings
and include these findings in the regulation. 15 U.S.C. 1262(i)(2).
These findings are discussed in paragraphs (a)(18)(ii)(B) through (D) of
this section.
(B) Voluntary standard. No findings concerning compliance with and
adequacy of a voluntary standard are necessary because no relevant
voluntary standard addressing the risk of injury
[[Page 430]]
posed by dive sticks has been adopted and implemented.
(C) Relationship of benefits to costs. The Commission estimates the
potential benefits of removing hazardous dive sticks from the market to
be 2 to 4 cents per dive stick. With the availability of substitutes and
the expected low cost of modifying dive sticks to conform to the rule,
the Commission anticipates that necessary changes will be minimal. The
Commission estimates that the costs of the rule will be no more than 2
to 4 cents per dive stick. Thus, the Commission finds that there is a
reasonable relationship between the expected benefits of the rule and
its costs.
(D) Least burdensome requirement. The Commission considered pursuing
voluntary recalls, following a voluntary standard, requiring labeling or
changing the scope of the rule. A banning rule would be more effective
than case-by-case recalls because the impalement hazard affects all dive
sticks, not a specific brand or model. Awaiting recalls would allow
these hazardous items on the market until the Commission obtained
recalls. No applicable voluntary standard exists, and compliance may be
low if one did. Although labeling could help reduce the risk of injuries
from dive sticks, it would be less effective than a banning rule. It may
be difficult for a label to convey the necessary information at the time
of use. Modifying the scope so that the rule would only apply to pre-
weighted dive sticks would continue to permit hazardous items because
the unweighted dive sticks can easily be weighted to stand vertically at
the bottom of the water. Thus, the Commission finds that a ban of dive
sticks with the hazardous characteristics it has identified is the least
burdensome alternative that would adequately reduce the risk of injury.
(b) Electrically operated toys and other electrical operated
children's articles presenting electrical, thermal, and/or certain
mechanical hazards. Under the authority of section 2(f)(1)(D) of the act
and pursuant to provisions of section 3(e) of the act, the Commission
has determined that the following types of electrically operated toys or
other electrically operated articles intended for use by children
present electrical, thermal, and/or certain mechanical hazards within
the meaning of section 2 (r), (s), and/or (t) of the act because in
normal use or when subjected to reasonably foreseeable damage or abuse,
the design or manufacture may cause personal injury or illness by
electric shock and/or presents an unreasonable risk of personal injury
or illness because of heat as from heated parts, substances, or
surfaces, or because of certain mechanical hazards.
(1) Any electrically operated toy or other electrically operated
article intended for use by children (as defined in Sec. 1505.1(a)(1))
that is introduced into interstate commerce and which does not comply
with the requirements of part 1505 of this chapter.
Note: Paragraph (b)(1) was originally promulgated as 21 CFR
191.9a(b)(1) with an effective date of September 3, 1973 (38 FR 6138).
(2) [Reserved]
(c) Toys and other articles (not electrically operated) presenting
electric hazards. Under the authority of section 2(f)(1)(D) of the act
and pursuant to provisions of section 3(e) of the act, the Commission
has determined that the following types of toys or other articles
intended for use by children (not electrically operated) present an
electrical hazard within the meaning of section 2(r) of the act.
(1) Any kite 10 inches or greater in any dimension constructed of
aluminized polyester film or any kite having a tail or other component
consisting of a piece of aluminized polyester film 10 inches or greater
in any dimension presents an electrical hazard and is a banned hazardous
substance because its design (specifically its size and electrical
conductivity) presents a risk of personal injury from electric shock due
to its ability to conduct electricity and to become entangled in or
otherwise contact high voltage electric power lines.
[[Page 431]]
(2) [Reserved]
(15 U.S.C. 1261 (f)(1)(D), (g)(1)(A), (r); 15 U.S.C. 1262(e)(1); 15
U.S.C. 2079(a))
[38 FR 27012, Sept. 27, 1973, as amended at 38 FR 30105, Nov. 1, 1973;
38 FR 32132, Nov. 21, 1973; 41 FR 4144, Jan. 28, 1976; 41 FR 6240, Feb.
12, 1976; 42 FR 36823, July 18, 1977; 42 FR 61594, Dec. 6, 1977; 43 FR
22005, May 23, 1978; 44 FR 34903, June 15, 1979; 44 FR 55819, Sept. 28,
1979; 48 FR 16, Jan. 3, 1983; 48 FR 57268, Dec. 29, 1983; 53 FR 46839,
Nov. 18, 1988; 57 FR 27915, June 23, 1992; 59 FR 9076, Feb. 25, 1994; 60
FR 10752, Feb. 27, 1995; 64 FR 71907, Dec. 22, 1999; 66 FR 13650, Mar.
7, 2001]
Sec. 1500.19 Misbranded toys and other articles intended for use by children.
(a) Definitions. For the purposes of this section, the following
definitions shall apply.
(1) Ball means a spherical, ovoid, or ellipsoidal object that is
designed or intended to be thrown, hit, kicked, rolled, dropped, or
bounced. The term ``ball'' includes any spherical, ovoid, or ellipsoidal
object that is attached to a toy or article by means of a string,
elastic cord, or similar tether. The term ``ball'' also includes any
multi-sided object formed by connecting planes into a generally,
spherical, ovoid, or ellipsoidal shape that is designated or intended to
be used as a ball, and any novelty item of a generally spherical, ovoid,
or ellipsoidal shape that is designated or intended to be used as a
ball. The term ``ball'' does not include dice, or balls permanently
enclosed inside pinball machines, mazes, or similar outer containers. A
ball is permanently enclosed if, when tested in accordance with 16 CFR
1500.53, it is not removed from the outer container.
(2) Small ball means a ball that, under the influence of its own
weight, passes, in any orientation, entirely through a circular hole
with a diameter of 1.75 inches (44.4 mm.) in a rigid template \1/4\
inches (6 mm.) thick. In testing to evaluate compliance with this
regulation, the diameter of opening in the Commission's test template
shall be no greater than 1.75 inches (44.4 mm.).
(3) Latex balloon means a toy or decorative item consisting of a
latex bag that is designed to be inflated by air or gas. The term does
not include inflatable children's toys that are used in aquatic
activities such as rafts, water wings, swim rings, or other similar
items.
(4) Marble means a ball made of a hard material, such as glass,
agate, marble or plastic, that is used in various children's games,
generally as a playing piece or marker. The term ``marble'' does not
include a marble permanently enclosed in a toy or game. A marble is
permanently enclosed if, when tested in accordance with 16 CFR 1500.53,
it is not removed from the toy or game.
(5) Small part means any object which, when tested in accordance
with the procedures contained in 16 CFR 1501.4(a) and 1501.4(b)(1), fits
entirely within the cylinder shown in Figure 1 appended to 16 CFR part
1501. The use and abuse testing provisions of 16 CFR 1500.51 through
1500.53 and 1501.4(b)(2) do not apply to this definition.
(6) Package or packaging refers to the immediate package in which a
product subject to labeling under section 24 of the act is sold, as well
as to any outer container or wrapping for that package.
(7) Descriptive material means any discrete piece of written
material separate from the label of the package that contains an
instruction (whether written or otherwise) for the use of a product
subject to these labeling requirements, any depiction of the product,
and any written material that specifically describes any function, use,
warnings, user population, design or material specification, or other
characteristic of the product. A catalog or other marketing material or
advertisement that depicts other products in addition to the product it
accompanies is not ``descriptive material'' unless it contains
additional information, such as instructions for use of the product it
accompanies or lists of accessories exclusively for use with that
product, that are designed to focus the purchaser's attention on the
product. Descriptive material ``accompanies'' a product subject to the
labeling requirements when it is packaged with the product or when it is
intended to be distributed with the product at the time of sale or
delivery to the purchaser. ``Descriptive material'' does not include
statements that appear on
[[Page 432]]
the package of a product subject to the labeling requirements.
``Descriptive material'' does not include material intended solely for
use by children if the package it accompanies contains a separate
package insert prominently identified as a warning for parents that
contains the required precautionary statements.
(8) Bin and container for retail display mean containers in which
multiple unpackaged and unlabeled items are held for direct selection by
and sale to consumers.
(b) Misbranded toys and children's articles. Pursuant to sections
2(p) and 24 of the FHSA, the following articles are misbranded hazardous
substances if their packaging, any descriptive material that accompanies
them, and, if unpackaged and unlabeled, any bin in which they are held
for sale, any container in which they are held for retail display, or
any vending machine from which they are dispensed, fails to bear the
labeling statements required in paragraphs (b) (1) through (4) and
paragraph (f)(3) of this section, or if such labeling statements fail to
comply with the prominence and conspicuousness requirements of paragraph
(d) of this section.
(1) With the exception of books and other articles made of paper,
writing materials such as crayons, chalk, pencils, and pens, modeling
clay and similar products, fingerpaints, watercolors, and other paint
sets, and any other article identified in 16 CFR 1501.3 (other than
balloons), any article that is a toy or game intended for use by
children who are at least three years old but less than six years of age
shall bear or contain the following cautionary statement if the toy or
game includes a small part:
[GRAPHIC] [TIFF OMITTED] TR27FE95.001
(2) Any latex balloon, or toy or game that contains a latex balloon,
shall bear the following cautionary statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.002
(3)(i) Any small ball intended for children three years of age or
older shall bear the following cautionary statement:
[[Page 433]]
[GRAPHIC] [TIFF OMITTED] TR27FE95.003
(ii) Any toy or game intended for children who are at least three
years old but less than eight years of age that contains a small ball
shall bear the following cautionary statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.004
(4)(i) Any marble intended for children three years of age or older
shall bear the following cautionary statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.005
(ii) Any toy or game intended for children who are at least three
years old but less than eight years of age that contains a marble shall
bear the following cautionary statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.006
(c) Age of intended user. In determining the ages of the children
for which any toy or article subject to this
[[Page 434]]
section is intended, the following factors are relevant: the
manufacturer's stated intent (such as the age stated on a label) if it
is reasonable; the advertising, marketing, and promotion of the article;
and whether the article is commonly recognized as being intended for
children in this age group. In enforcing this provision, the Commission
will follow the procedures set forth in 16 CFR 1501.5.
(d) Prominence and conspicuousness of labeling statements. The
requirements of 16 CFR 1500.121 relating to the prominence and
conspicuousness of precautionary labeling statements for hazardous
substances shall apply to any labeling statement required under
Sec. 1500.19(b) and (f), with the following clarifications and
modifications.
(1) All labeling statements required by Sec. 1500.19(b) and (f)
shall be in the English language. The statements required by paragraph
(b) need not appear in the format and layout depicted in paragraph (b).
The statements required by 16 CFR 1500.19(b) and (f) shall be blocked
together within a square or rectangular area, with or without a border.
This means that the statements must appear on at least two lines. The
statements shall be separated from all other graphic material by a space
no smaller than the minimum allowable height of the type size for other
cautionary material (e.g., the phrase ``Not for children under 3
yrs.''). If not separated by that distance, the labeling statements must
be surrounded by a border line. Label design, the use of vignettes, or
the proximity of other labeling or lettering shall not obscure or render
inconspicuous any labeling statement required under Sec. 1500.19(b) and
(f). This means that such statements shall appear on a solid background,
which need not differ from the background color or any other color on
the package label.
(2) The words ``WARNING'' or ``SAFETY WARNING'' required by section
24 of the FHSA shall be regarded as signal words.
(3) The statement ``CHOKING HAZARD'' shall be regarded as a
statement of the principal hazard associated with the products subject
to this section.
(4) All other remaining statements required by this section shall be
regarded as ``other cautionary material'' as that term is defined in 16
CFR 1500.121(a)(2)(viii).
(5) The principal display panel for a bin, container for retail
display, or vending machine shall be the side or surface designed to be
most prominently displayed, shown, or presented to, or examined by,
prospective purchasers. In the case of bins or containers for retail
display, the cautionary material may be placed on a display card of a
reasonable size in relationship to the surface area of the bin or
container. The area of the display card shall constitute the area of the
principal display panel. In the case of vending machines that contain a
display card, the cautionary label may be placed either on the display
card, on the coinage indicator decal, or on the glass or clear plastic
of the machine. If there is no display card inside a vending machine,
the size of the principal display panel will be calculated in accordance
with 16 CFR 1500.121(c) based on the size of the front of the container
from which items are dispensed, exclusive of the area of metal
attachments, coin inserts, bases, etc. Any other side or surface of such
a bin, container for retail sale, or vending machine that bears
information, such as price or product description, for examination by
purchasers shall be deemed to be a principal display panel, excluding
any side or surface with information that only identifies the company
that owns or operates a vending machine.
(6) All of the labeling statements required by this section,
including those classified as ``other cautionary material,'' must appear
on the principal display panel of the product, except as provided for by
Sec. 1500.19(f). Any signal word shall appear on the same line and in
close proximity to the triangle required by section 24 of the act.
Multiple messages should be provided with sufficient space between them,
when feasible, to prevent them from visually blending together.
(7) All labeling statements required by this section shall comply
with the following type size requirements. 16 CFR 1500.121(c)(1)
explains how to compute the area of the principal display panel and
letter height.
[[Page 435]]
Area sq. in....................... 0-2 +2-5 +5-10 +10-15 +15-30 +30-100 +100-400 +400
Type Size......................... ....... ....... ....... ........ ........ ......... .......... ......
Sig. Wd........................... \3/ \1/ \3/ \7/64\'' \1/8\'' \5/32\'' \1/4\'' \1/
64\'' 16\'' 32\'' 2\''
St. Haz........................... \3/ \3/ \1/ \3/32\'' \3/32\'' \7/64\'' \5/32\'' \1/
64\'' 64\'' 16\'' 4\''
Oth. Mat.......................... \1/ \3/ \1/ \1/16\'' \5/64\'' \3/32\'' \7/64\'' \5/
32\'' 64\'' 16\'' 32\''
(8) Labeling required by this section that appears on a bin,
container for retail display, or vending machine shall be in reasonable
proximity to any pricing or product information contained on the
principal display panel, or, if such information is not present, in
close proximity to the article that is subject to the labeling
requirements.
(9) Descriptive material that accompanies a product subject to the
labeling requirements, including accompanying material subject to the
alternative allowed by Sec. 1500.19(f), shall comply with the
requirements of 16 CFR 1500.121(c)(6) relating to literature containing
instructions for use which accompanies a hazardous substance. If the
descriptive material contains instructions for use, the required
precautionary labeling shall be in reasonable proximity to such
instructions or directions and shall be placed together within the same
general area (see 16 CFR 1500.121(c)(6)).
(10) In the case of any alternative labeling statement permitted
under Sec. 1500.19(e), the requirements of 16 CFR 1500.121(b)(3) and
1500.121(c)(2)(iii) shall apply to statements or indicators on the
principal display panel directing attention to the complete cautionary
labeling that appears on another display panel.
(11) Any triangle required by this section shall be an equilateral
triangle. The height of such a triangle shall be equal to or exceed the
height of the letters of the signal word ``WARNING''. The height of the
exclamation point inside the triangle shall be at least half the height
of the triangle, and the exclamation point shall be centered vertically
in the triangle. The triangle shall be separated from the signal word by
a distance at least equal to the space occupied by the first letter of
the signal word. In all other respects, triangles with exclamation
points shall conform generally to the provisions of 16 CFR 1500.121
relating to signal words.
(e) Combination of labeling statements. The labels of products that
contain more than one item subject to the requirements of this section
may combine information relating to each of the respective hazards, if
the resulting condensed statement contains all of the information
necessary to describe the hazard presented by each article. However, in
the case of a product that contains a balloon and another item subject
to the labeling requirements, only the signal word and statement of
hazard may be combined.
(f) Alternative labeling statements for small packages. Any
cautionary statement required by section 1500.19(b) may be displayed on
a display panel of the package of a product subject to the labeling
requirement other than the principal display panel only if:
(1) The package has a principal display panel of 15 square inches or
less,
(2) The full labeling statement required by paragraph (b) of this
section is displayed in three or more languages on another display panel
of the package of the product, and
(3)(i) In the case of a toy or game subject to Sec. 1500.19(b)(1), a
small ball subject to Sec. 1500.19(b)(3), a marble subject to
Sec. 1500.19(b)(4), or a toy or game containing such a ball or marble,
the principal display panel of the package bears the statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.007
[[Page 436]]
and bears an arrow or other indicator pointing toward or directing the
purchaser's attention to the display panel on the package where the full
labeling statement appears, or
(ii) In the case of a balloon subject to Sec. 1500.19(b)(2) or a toy
or game containing such a balloon, the principal display panel bears the
statement:
[GRAPHIC] [TIFF OMITTED] TR27FE95.008
and bears an arrow or other indicator pointing toward or directing the
purchaser's attention to the display panel on the package where the full
labeling statement appears.
(g) Alternative for products manufactured outside the United States.
In the case of a product subject to the labeling requirements of
Sec. 1500.19(b) which is manufactured outside the United States and is
shipped directly from the manufacturer to the consumer by United States
mail or other delivery service in an immediate package that contains
descriptive material, the descriptive material inside the immediate
package of the product need not bear the required labeling statement
only if the shipping container of the product contains other
accompanying material that bears the required statements displayed in a
prominent and conspicuous manner. Products shipped from abroad to a U.S.
affiliate for shipment to consumers are included within the scope of
this exception.
(h) Preemption. Section 101(e) of the Child Safety Protection Act of
1994 prohibits any state or political subdivision of a state from
enacting or enforcing any requirement relating to cautionary labeling
addressing small parts hazards or choking hazards associated with any
toy, game, marble, small ball, or balloon intended or suitable for use
by children unless the state or local requirement is identical to a
requirement established by section 24 of the FHSA or by 16 CFR 1500.19.
Section 101(e) allows a state or political subdivision of a state to
enforce a non-identical requirement relating to cautionary labeling
warning of small parts hazards or choking hazards associated with any
toy subject to the provisions of section 24 of FHSA until January 1,
1995, if the non-identical requirement was in effect on October 2, 1993.
[60 FR 10752, Feb. 27, 1995, as amended at 60 FR 41802, Aug. 14, 1995]
Sec. 1500.40 Method of testing toxic substances.
The method of testing the toxic substances referred to in
Sec. 1500.3(c) (1)(ii)(C) and (2)(iii) is as follows:
(a) Acute dermal toxicity (single exposure). In the acute exposures,
the agent is held in contact with the skin by means of a sleeve for
periods varying up to 24 hours. The sleeve, made of rubber dam or other
impervious material, is so constructed that the ends are reinforced with
additional strips and should fit snugly around the trunk of the animal.
The ends of the sleeve are tucked, permitting the central portion to
``balloon'' and furnish a reservoir for the dose. The reservoir must
have sufficient capacity to contain the dose without pressure. In the
following table are given the dimensions of sleeves and the approximate
body surface exposed to the test substance. The sleeves may vary in size
to accommodate smaller or larger subjects. In the testing of unctuous
materials that adhere readily to the skin, mesh wire screen may be
employed instead of the sleeve. The screen is padded and raised
approximately 2 centimeters from the exposed skin. In the case of dry
powder preparations, the skin and substance are moistened with
physiological saline prior to exposure. The sleeve or screen is then
slipped over the gauze that holds the dose applied to the skin. In the
case of finely divided powders, the measured dose is evenly distributed
on cotton gauze which is then secured to the area of exposure.
[[Page 437]]
Dimensions of Sleeves for Acute Dermal Toxicity Test
[Test animal--Rabbits]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Measurements in centimeters Average percentage
-------------------------------------------------------------------------------- Range of weight of Average area of exposure of total body
Diameter at ends Overall length animals (grams) (square centimeters) surface
--------------------------------------------------------------------------------------------------------------------------------------------------------
7.0 12.5 2,500-3,500 240 10.7
--------------------------------------------------------------------------------------------------------------------------------------------------------
(b) Preparation of test animal. The animals are prepared by clipping
the skin of the trunk free of hair. Approximately one-half of the
animals are further prepared by making epidermal abrasions every 2 or 3
centimeters longitudinally over the area of exposure. The abrasions are
sufficiently deep to penetrate the stratum corneum (horny layer of the
epidermis) but not to distrub the derma; that is, not to obtain
bleeding.
(c) Procedures for testing. The sleeve is slipped onto the animal
which is then placed in a comfortable but immobilized position in a
multiple animal holder. Selected doses of liquids and solutions are
introduced under the sleeve. If there is slight leakage from the sleeve,
which may occur during the first few hours of exposure, it is collected
and reapplied. Dosage levels are adjusted in subsequent exposures (if
necessary) to enable a calculation of a dose that would be fatal to 50
percent of the animals. This can be determined from mortality ratios
obtained at various doses employed. At the end of 24 hours the sleeves
or screens are removed, the volume of unabsorbed material (if any) is
measured, and the skin reactions are noted. The subjects are cleaned by
thorough wiping, observed for gross symptoms of poisoning, and then
observed for 2 weeks.
Sec. 1500.41 Method of testing primary irritant substances.
Primary irritation to the skin is measured by a patch-test technique
on the abraded and intact skin of the albino rabbit, clipped free of
hair. A minimum of six subjects are used in abraded and intact skin
tests. Introduce under a square patch, such as surgical gauze measuring
1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the
case of liquids) or 0.5 gram (in the case of solids and semisolids) of
the test substance. Dissolve solids in an appropriate solvent and apply
the solution as for liquids. The animals are immobilized with patches
secured in place by adhesive tape. The entire trunk of the animal is
then wrapped with an impervious material, such as rubberized cloth, for
the 24-hour period of exposure. This material aids in maintaining the
test patches in position and retards the evaporation of volatile
substances. After 24 hours of exposure, the patches are removed and the
resulting reactions are evaluated on the basis of the designated values
in the following table:
------------------------------------------------------------------------
Skin reaction Value \1\
------------------------------------------------------------------------
Erythema and eschar formation:
No erythema................................................ 0
Very slight erythema (barely perceptible).................. 1
Well-defined erythema...................................... 2
Moderate to severe erythema................................ 3
Severe erythema (beet redness) to slight eschar formations 4
(injuries in depth).......................................
Edema formation:
No edema................................................... 0
Very slight edema (barely perceptible)..................... 1
Slight edema (edges of area well defined by definite 2
raising)..................................................
Moderate edema (raised approximately 1 millimeter)......... 3
Severe edema (raised more than 1 millimeter and extending 4
beyond the area of exposure)..............................
------------------------------------------------------------------------
\1\ The ``value'' recorded for each reading is the average value of the
six or more animals subject to the test.
Readings are again made at the end of a total of 72 hours (48 hours
after the first reading). An equal number of exposures are made on areas
of skin that have been previously abraded. The abrasions are minor
incisions through the stratum corneum, but not sufficiently deep to
disturb the derma or to produce bleeding. Evaluate the reactions of the
abraded skin at 24 hours and 72 hours, as described in this paragraph.
Add the values for erythema and eschar formation at 24 hours and at 72
hours for intact skin to the values on abraded skin at 24 hours and at
72 hours (four values). Similarly, add the values for edema formation at
24 hours
[[Page 438]]
and at 72 hours for intact and abraded skin (four values). The total of
the eight values is divided by four to give the primary irritation
score; for example:
------------------------------------------------------------------------
Exposure
Skin reaction time Evaluation
(hours) value
------------------------------------------------------------------------
Erythema and eschar formation:
Intact skin.................................... 24 2
Do............................................ 72 1
Abraded skin................................... 24 3
Do............................................ 72 2
----------------------
Subtotal.................................... ......... 8
======================
Edema formation:
Intact skin.................................... 24 0
Do............................................ 72 1
Abraded skin................................... 24 1
Do............................................ 72 2
----------------------
Subtotal.................................... ......... 4
======================
Total....................................... ......... 12
------------------------------------------------------------------------
Thus, the primary irritation score is 12/4=3.
Sec. 1500.42 Test for eye irritants.
(a)(1) Six albino rabbits are used for each test substance. Animal
facilities for such procedures shall be so designed and maintained as to
exclude sawdust, wood chips, or other extraneous materials that might
produce eye irritation. Both eyes of each animal in the test group shall
be examined before testing, and only those animals without eye defects
or irritation shall be used. The animal is held firmly but gently until
quiet. The test material is placed in one eye of each animal by gently
pulling the lower lid away from the eyeball to form a cup into which the
test substance is dropped. The lids are then gently held together for
one second and the animal is released. The other eye, remaining
untreated, serves as a control. For testing liquids, 0.1 milliliter is
used. For solids or pastes, 100 milligrams of the test substance is
used, except that for substances in flake, granule, powder, or other
particulate form the amount that has a volume of 0.1 milliliter (after
compacting as much as possible without crushing or altering the
individual particles, such as by tapping the measuring container) shall
be used whenever this volume weighs less than 100 milligrams. In such a
case, the weight of the 0.1 milliliter test dose should be recorded. The
eyes are not washed following instillation of test material except as
noted below.
(2) The eyes are examined and the grade of ocular reaction is
recorded at 24, 48, and 72 hours. Reading of reactions is facilitated by
use of a binocular loupe, hand slit-lamp, or other expert means. After
the recording of observations at 24 hours, any or all eyes may be
further examined after applying fluorescein. For this optional test, one
drop of fluorescein sodium ophthalmic solution U.S.P. or equivalent is
dropped directly on the cornea. After flushing out the excess
fluorescein with sodium chloride solution U.S.P. or equivalent, injured
areas of the cornea appear yellow; this is best visualized in a darkened
room under ultraviolet illumination. Any or all eyes may be washed with
sodium chloride solution U.S.P. or equivalent after the 24-hour reading.
(b)(1) An animal shall be considered as exhibiting a positive
reaction if the test substance produces at any of the readings
ulceration of the cornea (other than a fine stippling), or opacity of
the cornea (other than a slight dulling of the normal luster), or
inflammation of the iris (other than a slight deepening of the folds (or
rugae) or a slight circumcorneal injection of the blood vessels), or if
such substance produces in the conjunctivae (excluding the cornea and
iris) an obvious swelling with partial eversion of the lids or a diffuse
crimson-red with individual vessels not easily discernible.
(2) The test shall be considered positive if four or more of the
animals in the test group exhibit a positive reaction. If only one
animal exhibits a positive reaction, the test shall be regarded as
negative. If two or three animals a positive reaction, the test is
repeated using a different group of six animals. The second test shall
be considered positive if three or more of the animals exhibit a
positive reaction. If only one or two animals in the second test exhibit
a positive reaction, the test shall be repeated with a different group
of six animals. Should a third test be needed, the substance will be
regarded as an irritant if any animal exhibits a positive response.
[[Page 439]]
(c) To assist testing laboratories and other interested persons in
interpreting the results obtained when a substance is tested in
accordance with the method described in paragraph (a) of this section,
an ``Illustrated Guide for Grading Eye Irritation by Hazardous
Substances'' will be sold by the Superintendent of Documents, U.S.
Government Printing Office, Washington, D.C. 20402. \1\ The guide will
contain color plates depicting responses of varying intensity to
specific test solutions. The grade of response and the substance used to
produce the response will be indicated.
---------------------------------------------------------------------------
\1\ The Illustrated Guide is out of print and, as of January 1,
1981, no longer available. However, information about the test method,
and black and white photocopies may be obtained by writing to the
Directorate for Epidemiology and Health Sciences, CPSC, Washington, D.C.
20207, (301) 504-0957.
[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973; 62 FR 46667,
Sept. 4, 1997]
Sec. 1500.43 Method of test for flashpoint of volatile flammable materials by Tagliabue open-cup apparatus.
Scope
1. (a) This method describes a test procedure for the determination
of open-cup flashpoints of volatile flammable materials having
flashpoints below 175 deg.F.
(b) This method, when applied to paints and resin solutions which
tend to skin over or which are very viscous, gives less reproducible
results than when applied to solvents.
Outline of Method
2. The sample is placed in the cup of a Tag Open Tester, and heated
at a slow but constant rate. A small test flame is passed at a uniform
rate across the cup at specified intervals. The flashpoint is taken as
the lowest temperature at which application of the test flame causes the
vapor at the surface of the liquid to flash, that is, ignite but not
continue to burn.
Apparatus
3. The Tag open-cup tester is illustrated in Fig. 1. It consists of
the following parts, which must conform to the dimensions shown, and
have the additional characteristics as noted:
[GRAPHIC] [TIFF OMITTED] TC03OC91.051
(a) Copper bath, preferably equipped with a constant level overflow
so placed as to maintain the bath liquid level \1/8\-inch below the rim
of the glass cup.
(b) Thermometer holder. Support firmly with ringstand and clamp.
(c) Thermometer. For flashpoints above 40 deg.F., use the ASTM Tag
Closed Tester Thermometer, range of +20 to +230 deg.F., in 1 deg.F.
divisions, and conforming to thermometer 9F. of ASTM Standard E 1. For
flashpoints from 20 deg.F. to 40 deg.F., use ASTM Tag Closed Tester,
Low Range, Thermometer 57F. For flashpoints below 20 deg.F., use ASTM
Thermometer 33F. The original Tag Open-Cup (Paper Scale) Thermometer
will be a permissible alternate until January 1, 1962. It is calibrated
to -20 deg.F.
(d) Glass test cup. Glass test cup (Fig. 2), of molded clear glass,
annealed, heat-resistant, and free from surface defects.
[[Page 440]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.052
(e) Leveling device. Leveling device or guide, for proper adjustment
of the liquid level in the cup (Fig. 3). This shall be made of No. 18-
gage polished aluminum, with a projection for adjusting the liquid level
when the sample is added to exactly \1/8\-inch below the level of the
edge or rim of the cup.
[GRAPHIC] [TIFF OMITTED] TC03OC91.053
(f) ``Micro,'' or small gas burner of suitable dimensions for
heating the bath. A screw clamp may be used to help regulate the gas. A
small electric heater may be used.
(g) Ignition taper, which is a small straight, blow-pipe type gas
burner. The test flame torch prescribed in the method of test for flash
and fire points by Cleveland Open Cup (ASTM designation: D 92) is
satisfactory.
(h) Alternative methods for maintaining the ignition taper in a
fixed horizontal plane above the liquid may be used, as follows:
(1) Guide wire, \3/32\-inch in diameter and 3\1/2\ inches in length,
with a right-angle bend \1/2\-inch from each end. This wire is placed
snugly in holes drilled in the rim of the bath, so that the guide wire
is \5/8\-inch from the center of the cup and resting on the rim of the
cup.
(2) Swivel-type taper holder, such as is used in ASTM METHOD D 92.
The height and position of the taper are fixed by adjusting the holder
on a suitable ringstand support adjacent to the flash cup.
(i) Draft shield, consisting of two rectangular sheets of
noncombustible material, 24 inches x 28 inches, are fastened together
along the 28-inch side, preferably by hinges. A triangular sheet, 24
inches x 24 inches x 34 inches is fastened by hinges to one of the
lateral sheets (to form a top when shield is open). The interior of the
draft shield shall be painted a flat black.
Procedure
4. (a) Place the tester on a solid table free of vibration, in a
location free of perceptible draft, and in a dim light.
(b) Run water, brine, or water-glycol solution into the bath to a
predetermined level, which will fill the bath to \1/8\-inch below the
top when the cup is in place. An overflow is permissible for water-level
control.
(c) Firmly support the thermometer vertically halfway between the
center and edge of the cup on a diameter at right angles to the guide
wire, or on a diameter passing through the center of the cup and the
pivot of the taper. Place so that the bottom of the bulb is \1/4\-inch
from the inner bottom surface of the cup. If the old Tagliabue
thermometer is used, immerse to well cover the mercury bulb, but not the
wide body of the thermometer.
(d) Fill the glass cup with the sample liquid to a depth just \1/8\-
inch below the edge, as determined by the leveling device.
(e) Place the guide wire or swivel device in position, and set the
draft shield around the tester so that the sides from right angles with
each other and the tester is well toward the back of the shield.
(f) If a guide wire is used, the taper, when passed, should rest
lightly on the wire, with the end of the jet burner just clear of the
edge of the guide wire. If the swivel-type holder is used, the
horizontal and vertical positions to the jet are so adjusted that the
jet passes on the circumference of a circle, having a radius of at least
6 inches, across the center of the cup at right angles to the diameter
passing through the thermometer, and in a plane \1/8\-inch above the
upper edge of the cup. The taper should be kept in the ``off'' position,
at one end or the other of the swing, except when the flame is applied.
(g) Light the ignition flame and adjust it to form a flame of
spherical form matching in size the \5/52\-inch sphere on the apparatus.
(h) Adjust heater source under bath so that the temperature of the
sample increases at a rate of 20.5 deg.F. per minute. With
viscous materials this rate of heating cannot always be obtained.
Initial Test
5. Determine an approximate flashpoint by passing the taper flame
across the sample at
[[Page 441]]
intervals of 2 deg.F. Each pass must be in one direction only. The time
required to pass the ignition flame across the surface of the sample
should be 1 second. Remove bubbles from the surface of the sample liquid
before starting a determination. Meticulous attention to all details
relating to the taper, size of taper flame, and rate of passing the
taper is necessary for good results. When determining the flashpoint of
viscous liquids and those liquids that tend to form a film of polymer,
etc., on the surface, the surface film should be disturbed mechanically
each time before the taper flame is passed.
Recorded Tests
6. Repeat the procedure by cooling a fresh portion of the sample,
the glass cup, the bath solution, and the thermometer at least 20
deg.F. below the approximate flashpoint. Resume heating, and pass the
taper flame across the sample at two intervals of 2 deg.F. until the
flashpoint occurs.
Reporting Data
7. The average of not less than three recorded tests, other than the
initial test, shall be used in determining the flashpoint and
flammability of the substance.
Standardization
8. (a) Make determinations in triplicate on the flashpoint of
standard paraxylene and of standard isopropyl alcohol which meet the
following specifications:
(i) Specifications for p-xylene, flashpoint check grade. p-xylene
shall conform to the following requirements;
Specific gravity: 15.56 deg.C./15.56 deg.C., 0.860 minimum, 0.866
maximum
Boiling range: 2 deg.C. maximum from start to dry point when tested in
accordance with the method of test for distillation of industrial
aromatic hydrocarbons (ASTM designation: D 850), or the method of test
for distillation range of lacquer solvents and diluents (ASTM)
designation D 1078). The range shall include the boilng point of pure P-
xylene, which is 138.35 deg.C. (281.03 deg.F.).
Purity: 95 percent minimum, calculated in accordance with the method of
test for determination of purity from freezing points of high-purity
compounds (ASTM designation: D 1016), from the experimentally determined
freezing point, measured by the method of test for measurement of
freezing points of high-purity compounds for evaluation of purity (ASTM
designation: D 1015).
(ii) Specifications for ispropanol, flash point check grade.
Isopropanol shall conform to the following requirements:
Specific gravity: 0.8175 to 0.8185 at 20 deg.C./20 deg.C. as
determined by means of a calibrated pycnometer.
Distillation range: Shall entirely distill within a 1.0 deg.C. range
which shall include the temperature 80.4 deg.C. as determined by ASTM
method D 1078.
Average these values for each compound. If the difference between the
values for these two compounds is less than 15 deg.F. (8.5 deg.C.) or
more than 27 deg.F. (16 deg.C.), repeat the determinations or obtain
fresh standards.
(b) Calculate a correction factor as follows:
X = 92 - A
Y = 71 - B
Correction = (X + Y) / 2.
Where:
A=Observed flash of p- xylene, and
B=Observed flash of isopropyl alcohol.
Apply this correction of all determinations.
Half units in correction shall be discarded.
Precision
9. (a) For hydrocarbon solvents having flashpoints between 60
deg.F. and 110 deg.F., repeatability is 2 deg.F. and the
reproducibility is 5 deg.F.
(b) If results from two tests differ by more than 10 deg.F., they
shall be considered uncertain and should be checked. This calibration
procedure provided in this method will cancel out the effect of
barometric pressure if calibration and tests are run at the same
pressure. Data supporting the precision are given appendix III of the
1956 Report of Committee D-1 on Paint, Varnish, Lacquers and Related
Products, Proceedings, Am. Soc. Testing Mats., Vol. 56 (1956).
Note: The test apparatus and procedure described in Sec. 1500.43 may
be used by manufacturers and labelers of products subject to the Federal
Hazardous Substances Act to determine flashpoint temperatures of those
products under the conditions set forth in Sec. 1500.3(c)(6)(iv), as
amended.
[51 FR 28537, Aug. 8, 1986]
Sec. 1500.43a Method of test for flashpoint of volatile flammable materials.
(a) Scope. (1) This method describes the test procedure which the
Commission will use for the determination of the flashpoint of volatile
flammable materials, using a Setaflash \1\ low-range closed tester, or
an apparatus producing equivalent results. The method described in this
section is essentially a Setaflash equilibrium procedure which closely
parallels the test method designated ASTM D 3828-81, ``Standard Test
Methods for Flash Point by
[[Page 442]]
Setaflash Closed Tester,'' published by the American Society for Testing
and Materials (ASTM), 1916 Race Street, Philadelphia, Pennsylvania
19103. Manufacturers and labelers of products subject to labeling and
other requirements under the Federal Hazardous Substances Act may use
other apparatus and/or test methods which produce equivalent results.
---------------------------------------------------------------------------
\1\ Setaflash is a registered trademark of Stanhope-Seta Limited,
Surrey, England.
---------------------------------------------------------------------------
(2) At the option of the user, the procedures described in this
section may be used to determine the actual flashpoint temperature of a
sample or to determine whether a product will or will not flash at a
specified temperature (flash/no flash).
(3) If the substance to be tested has a viscosity greater than 150
Stokes at 77 deg.F (25 deg.C), see paragraph (n) of this section for
modifications to the testing procedure.
(4) If the Commission has reason to believe on the basis of reliable
experience or other relevant information or data that the flammability
hazard of a substance is greater or less than its flammability
classification based on flashpoint temperature determined in accordance
with this Sec. 1500.43a and that the substance should be reclassified,
the Commission will initiate a rulemaking proceeding for
reclassification of the substance. Product manufacturers and labelers
may use reliable experience or other relevant information or data in
addition to the flashpoint temperature of a substance as a basis for
compliance with any applicable requirements of the Federal Hazardous
Substances Act in the absence of a rule issued by the Commission to
reclassify the substance.
(b) Summary of test methods. (1) Method A--Flash/No Flash Test. A
specified volume of sample is introduced by a syringe into the cup of
the apparatus that is set and maintained at the specified temperature.
After a specific time a test flame is applied and an observation made as
to whether or not a flash occurred. Test procedures are set forth in
detail in Sec. 1500.43a(i).
(2) Method B--Finite (or Actual) Flashpoint. (i) A specified voume
of sample is introduced into the cup of the apparatus that is maintained
at the expected flashpoint. After a specified time a test flame is
applied and the observation made whether or not a flash occurred.
(ii) The specimen is removed from the cup, the cup cleaned, and the
cup temperature adjusted 5 deg.C (9 deg.F), lower or higher depending
on whether or not a flash occurred previously. A fresh specimen is
introduced and tested. This procedure is repeated until the flashpoint
is established within 5 deg.C (9 deg.F).
(iii) The procedure is then repeated at 1 deg.C (2 deg.F)
intervals until the flashpoint is determined to the nearest 1 deg.C (2
deg.F).
(iv) If improved accuracy is desired the procedure is repeated at
0.5 deg.C (1 deg.F). Test procedures are set forth in detail at
Sec. 1500.43a(j).
(3) The test procedures will be modified, where necessary, to ensure
that the results obtained reflect the hazard of the substance under
reasonably foreseeable conditions of use. Thus, for example, the
material, if a mixture, will normally be tested as it comes from the
container, and/or after a period of evaporation. The period of
evaporation for a material which is a mixture will normally be the time
required for the mixture to evaporate in an open beaker under ambient
conditions to 90 percent of its original volume, or a period of four
hours, whichever occurs first. However, this period of evaporation will
be changed if the results obtained do not represent the hazard of the
substance under reasonably foreseeable conditions of use.
(c) Definition of flashpoint. The lowest temperature of the sample,
corrected to a barometric pressure of 101.3 kPa (760 mm Hg), at which
application of a test flame causes the vapor of the sample to ignite
under specified conditions of test. The sample is deemed to have flashed
when a large flame appears and instantaneously propagates itself over
the surface of the sample. Occasionally, particularly near actual
flashpoint, the application of the test flame will cause a halo or an
enlarged flame; this is not a flash and should be ignored.
(d) Test apparatus. The test apparatus is an equilibrium closed-cup
tester with a range up to 100 deg.C (212 deg.F). The essential
dimensions and requirements are shown in figure 1 and table 3, and
[[Page 443]]
are described in Sec. 1500.43a(m). Closed-cup flashpoint testers and
accessories meeting these requirements are available from commercial
suppliers and distributors of laboratory equipment.
(e) Safety precautions. The operator must exercise and take
appropriate safety precautions during the initial application of the
test flame to the sample. Samples containing low-flash material may give
an abnormally strong flash when the test flame is first applied.
(f) Preparation of samples. (1) Erroneously high flashpoints may be
obtained if precautions are not taken to avoid the loss of volatile
material. In preliminary tests of materials taken directly from the
container, do not open containers unnecessarily and make a transfer
unless the sample temperature is at least 10 deg.C (18 deg.F) below
the expected flashpoint. Do not use samples in leaky containers for this
test.
(2) Do not store samples in plastic (polyethylene, polypropylene,
etc.) bottles since volatile material may diffuse through the walls of
the bottle.
(3) A 2-ml specimen is required for each test. If possible, obtain
at least a 50-ml sample from the bulk test site and store in a clean,
tightly closed container.
(g) Preparation of apparatus. (1) Place the tester on a level,
stable surface. Unless tests are made in a draft-free area, surround the
tester on three sides with a shield for protection. Do not rely on tests
made in a laboratory draft hood or near ventilators.
(2) Read the manufacturer's instructions on the care and servicing
of the instrument and for correct operation of its controls.
(h) Calibration and standardization. (1) Before initial use
determine and plot the relationship between the temperature control dial
and the thermometer readings at each major (numbered) dial division as
follows:
Turn the temperature control knob \2\ fully counterclockwise (``O''
reading). Advance the temperature control knob clockwise until the
indicator light is illuminated.\3\ Advance the knob clockwise to the
next numbered line. After the thermometer mercury column ceases to
advance, record the dial reading and the temperature. Advance the knob
clockwise to the next numbered line. After the thermometer mercury
column ceases to advance, read the dial reading and the temperature.
Repeat this procedure through the full range of the instrument. Plot the
dial readings versus the respective temperatures.
---------------------------------------------------------------------------
\2\ If the instrument has two temperature control knobs, set the
fine control (center, small knob) at its mid-position and allow it to
remain there throughout the calibration. The calibration is determined
by adjusting the coarse control (large, outer knob) only.
\3\ When using the tester, it will be found that the indicator light
may not illuminate and the temperature may not rise until a temperature
control dial setting between one and two is reached.
---------------------------------------------------------------------------
(2) Standardize the instrument using a sample of material meeting
the specifications in table 1. If the average of two determinations
falls within the acceptable limits the instrument is assumed to be
operating properly. If the average of the two determinations does not
fall within this range, check the manufacturer's operating and
maintenance instructions and determine that they are being followed. In
particular, be sure that the cup lid assembly makes a vapor-tight seal
with the cup, the shutter provides a light-tight seal, and that adequate
heat transfer paste surrounds the thermometer bulb and the immersed
portion of the barrel.
(i) Test Method A--for determining Flash/No Flash.
(1) Determine the target flashpoint as follows:
(i) Target flashpoint, deg.C=Sc--0.25 (101.3--A)
(ii) Target flashpoint, deg.C=Sc--0.03 (760-B)
(iii) Target flashpoint, deg.F=Sf--0.06 (760-B)
where:
Sc=specification, or uncorrected target, flashpoint, deg.C,
Sf=specification, or uncorrected target, flashpoint, deg.F,
B=ambient barometric pressure, mm Hg,\4\ and
[[Page 444]]
A=ambient barometer pressure, kPa.\4\
\4\ The barometric pressure used in this calculation must be the
ambient pressure for the laboratory at the time of test. Many aneroid
barometers, such as those used at weather stations and airports, are
precorrected to give sea-level readings; these must not be used.
---------------------------------------------------------------------------
(2) Inspect the inside of the sample cup, lid, and shutter mechanism
for cleaniness and freedom from contamination. Use an absorbent paper
tissue to wipe clean, if necessary. Put cover in place and lock
securely. The filing orifice may be convenienty cleaned with a pipe
cleaner.
(3) Set the instrument at the target temperature.
(i) For target temperature below ambient. The instrument power
switch is to be in the off position. Fill the refigerant-charged cooling
block with a suitable material.\5\ Raise the lid and shutter assembly,
and position the base of the block in the sample cup, being careful not
to injure or mar the cup. When the thermometer reads approximately 6 to
10 deg.C (10 to 20 deg.F) below the target temperature, remove the
cooling block and quickly dry the cup with a paper tissue to remove any
moisture. Immediately close the lid and shutter assembly and secure.
Prepare to introduce the sample using the syringe, both of which have
been precooled to a temperature 5 to 10 deg.C (10 to 20 deg.F) below
the target temperature.
---------------------------------------------------------------------------
\5\ If the target or specification temperature is not less than 5
deg.C (40 deg.F) crushed ice and water may be used as charging
(cooling) fluid. If below 5 deg.C (40 deg.F), a suitable charging
(cooling) fluid is solid carbon dioxide (dry ice) and acetone. If the
refrigerant charged cooling module is unavailable, refer to the
manufacturer's instruction manual for alternative methods of cooling.
---------------------------------------------------------------------------
(A) Caution: Do not cool the sample block below --38 deg.C, the
freezing point of mercury.
(B) Caution: Acetone is extremely flammable. Keep away from heat,
sparks, and flames and keep container closed when not actually pouring
acetone. Use only in a well-ventilated area. Avoid inhalation and
contact with the eyes or skin. Use cloth or leather gloves, goggles or
safety shield, and keep dry ice in a canvas bag, especially when
cracking.
(ii) For target temperature above ambient. Switch the instrument on
and turn the coarse temperature control knob fully clockwise (full on)
causing the indicator light to illuminate.\6\ When the thermometer
indicates a temperature about 3 deg.C (5 deg.F) below the target (or
specification) temperature, reduce the heat input to the sample cup by
turning the coarse temperature control knob counter-clockwise to the
desired control point (see Sec. 1500.43a(i)(1)). When the indicator
light slowly cycles on and off read the temperature on the thermometer.
If necessary, adjust the fine (center) temperature control knob to
obtain the desired test (target) temperature. When the test temperature
is reached and the indicator lamp slowly cycles on and off, prepare to
introduce the sample.
---------------------------------------------------------------------------
\6\ The target temperature may be attained by originally turning the
coarse temperature control knob to the proper setting (see
Sec. 1500.43a(h)(1) for the temperature desired rather than the maximum
setting (full on). The elapsed time to reach the temperature will be
greater, except for maximum temperature. However, less attention will be
required during the intervening period.
---------------------------------------------------------------------------
(4) Charge the syringe with a 2-ml specimen of the sample \7\ to be
tested; transfer the syringe to the filling orifice, taking care not to
lose any sample; discharge the test specimen into the cup by fully
depressing the syringe plunger, remove the syringe.
---------------------------------------------------------------------------
\7\ For target or expected temperatures below ambient, both syringe
and sample must be precooled to cup temperature (see
Sec. 1500.43a(i)(3)(i)) before the specimen is taken.
---------------------------------------------------------------------------
(5)(i) Set the timer \8\ by rotating its knob clockwise to its stop.
Open the gas control valve and light the pilot and test flames. Adjust
the test flame with the pinch valve to conform to the size of the 4-mm
(5/32-in.) gage.
---------------------------------------------------------------------------
\8\ For target temperatures below ambient, do not set the timer.
Adjust the test flame and allow the temperature to rise under ambient
conditions until the target temperature is reached. Immediately apply
the test flame as detailed.
---------------------------------------------------------------------------
(ii) After the time signal indicates the specimen is at test
temperature \8\, apply the test flame by slowly and uniformly opening
the shutter and closing it completely over a period of approximately
2\1/2\ s.\9\ Watch closely for a flash at the cup openings.
---------------------------------------------------------------------------
\9\ Never apply the test flame to the specimen more than once. Fresh
portions of the sample must be used for each test.
---------------------------------------------------------------------------
[[Page 445]]
(iii) The sample is deemed to have flashed when a large flame
appears and instantaneously propagates itself over the surface of the
sample (see Sec. 1500.43a(c)).
(6) Record the test results as ``flash'' or ``no flash'' and the
test temperature.
(7) Turn off the pilot and test flames using the gas control valve.
Remove the sample and clean the instrument. It may be necessary to allow
the cup temperature to decline to a safe level before cleaning.
(j) Test Method B--for determining Finite or Actual Flashpoint. (1)
Inspect the inside of the sample cup, lid, and shutter mechanism for
cleanliness and freedom from contamination. Use an absorbent paper
tissue to wipe clean, if necessary. Put cover in place and lock
securely. The filling orifice may be conveniently cleaned with a pipe
cleaner.
(2) For expected flashpoints below ambient. (i) The instrument power
switch is to be in off position. Fill the refrigerant-charged cooling
block with a suitable material.\5\ Raise the lid and shutter assembly,
and position the base of the block in the sample cup, being careful not
to injure or mar the cup. When the thermometer reaches a temperature 5
to 10 deg.C (10 to 20 deg.F) below the expected flashpoint, remove the
cooling block and quickly dry the cup with a paper tissue to remove any
moisture. Immediately close the lid and shutter assembly and secure.
Prepare to introduce the sample using the syringe, both of which have
been precooled to a temperature 5 to 10 deg.C (10 to 20 deg.F) below
the expected temperature (See Sec. 1500.43a(j)(5)).
(ii) Caution: Do not cool the sample block below -38 deg.C, the
freezing point of mercury.
(3) For tests where the expected flashpoint is above ambient. Turn
the coarse temperature control knob fully clockwise (full on) causing
the indicator light to illuminate. When the thermometer reaches a
temperature 3 deg.C (5 deg.F) below the estimated flashpoint, turn the
coarse temperature knob counter-clockwise to the dial reading
representing the estimated flashpoint temperature as shown on the
calibration curve (See Sec. 1500.43a(h)(1)). When the indicator light
slowly cycles on and off, read the temperature on the thermometer. If
necessary, adjust the fine temperature control knob to obtain the exact
desired temperature.
(4)(i) Charge the syringe \7\ with a 2 ml specimen of the sample \7\
to be tested; transfer the syringe to the filling orifice, taking care
not to lose any sample; discharge the test specimen into the cup by
fully depressing the syringe plunger; remove the syringe.
(ii) Set the timer \10\ by rotating its knob clockwise to its stop.
Open the gas control valve and ignite the pilot and test flames. Adjust
the test flame with the pinch valve to conform to the size of the 4-mm
(\5/32\-in.) gage.
(iii) After the audible time signal indicates the specimen is at
test temperature,\10\ apply the test flame by slowly and uniformly
opening the shutter and then closing it completely over a period of
approximately 2\1/2\ s. Watch closely for a flash at the cup opening.
---------------------------------------------------------------------------
\10\ For expected flashpoint below ambient, do not set the timing
device. Adjust the test flame. Allow the temperature to rise under
ambient conditions until the temperature reaches 5 deg.C (9 deg.F)
below the expected flashpoint. Immediately apply the test flame.
---------------------------------------------------------------------------
(iv) The sample is deemed to have flashed only if a large flame
appears and instantaneously propagates itself over the surface of the
sample. (See Sec. 1500.43a(c).)
(v) Turn off the pilot and test flames using the gas control valve.
When the cup temperature declines to a safe level, remove the sample and
clean the instrument.
(5)(i) If a flash was observed in Sec. 1500.43a(j)(4)(iii) repeat
the procedure given in Sec. 1500.43a(j)(2) or (3), and in
Sec. 1500.43a(j)(4), testing a new specimen at a temperature 5 deg.C (9
deg.F) below that at which the flash was observed.
(ii) If necessary, repeat the procedure in Sec. 1500.43a(j)(5)(i),
lowering the temperature 5 deg.C (9 deg.F) each time, until no flash
is observed.\9\
(iii) Proceed to Sec. 1500.43a(j)(7).
(6)(i) If no flash was observed in Sec. 1500.43a(j)(4)(iii) repeat
the procedure given in Sec. 1500.43a(j)(2) or (3), and in
Sec. 1500.43a(j)(4), testing a fresh specimen at a temperature 5 deg.C
(9 deg.F) above that
[[Page 446]]
at which the specimen was tested in Sec. 1500.43a(j)(4)(iii).
(ii) If necessary repeat the procedure in Sec. 1500.43a(j)(6)(i),
above, raising the temperature 5 deg.C (9 deg.F) each time until a
flash is observed.\9\
(7) Having established a flash within two temperatures 5 deg.C (9
deg.F) apart, repeat the procedure at 1 deg.C (2 deg.F) intervals from
the lower of the two temperatures until a flash is observed.\9\ Record
the temperature of the test when this flash occurs as the flashpoint,
allowing for any known thermometer correction. Record the barometric
pressure.\4\
(8) The flashpoint determined in Sec. 1500.43a(j)(7) will be to the
nearest 1 deg.C (2 deg.F). If improved accuracy is desired (that is,
to the nearest 0.5 deg.C (1 deg.F)), test a fresh specimen at a
temperature 0.5 deg.C (1 deg.F) below that at which the flash was
observed in Sec. 1500.43a(j)(7). If no flash is observed, the
temperature recorded in Sec. 1500.43a(j)(7), is the flashpoint to the
nearest 0.5 deg.C (1 deg.F). If a flash is observed at the lower
temperature, record this latter temperature as the flashpoint.
(9) Turn off the pilot and test flames using the gas control valve.
When the cup temperature declines to a safe level, remove the sample and
clean the instrument.
(k) Calculations. If it is desired to correct the observed finite
flashpoint for the effect of barometric pressure, proceed as follows:
Observe and record the ambient barometric pressure\4\ at the time of the
test. If the pressure differs from 101.3 kPa (760 mm Hg), correct the
flashpoint as follows:
(1) Corrected flashpoint ( deg.C)=C+0.25 (101.3-A)
(2) Corrected flashpoint ( deg.F)=F+0.06 (760-B)
(3) Corrected flashpoint ( deg.C)=C+0.03 (760-B)
Where: F=Observed flashpoint, deg.F,
C=observed flashpoint, deg.C,
B=ambient barometric pressure, mm Hg; and
A=ambient barometric pressure, kPa.
(l) Precision. The precision of the method as determined by
statistical examination of interlaboratory results is as follows:
(1) Repeatability. The difference between two test results obtained
by the same operator with the same apparatus under constant operating
conditions on identical test material, would, in the long run, in the
normal and correct operation of the test method, exceed the values shown
in table 2 only in 1 case in 20.
(2) Reproducibility. The difference between two single and
independent results obtained by different operators working in different
laboratories on identical test material, would, in the long run, in the
normal and correct operation of the test method, exceed the values shown
in table 2 only in 1 case in 20.
(m) Flash Test Apparatus. (1)(i) Unit consisting of an aluminum
alloy or nonrusting metal block of suitable conductivity with a
cylindrical depression, or sample cup, over which is fitted a cover. A
thermometer is embedded in the block.
(ii) The cover is fitted with an opening slide and a device capable
of inserting an ignition flame (diameter 40.5 mm) into the
well when the slide device shall intersect the plane of the underside of
the cover. The cover is also provided with an orifice extending into the
sample well for insertion of the test sample and also a suitable
clamping device for securing the cover tightly to the metal block. The
three openings in the cover shall be within the diameter of the sample
well. When the slide is in the open position, the two openings in the
slide shall coincide exactly with the two corresponding openings in the
cover.
(iii) Electrical heaters are attached to the bottom of the cup in a
manner that provides efficient transfer of heat. An electronic heat
control is required to hold the equilibrium temperature, in a draft-free
area, within 0.1 deg.C (0.2 deg.F) for the low-temperature tester. A
visual indicator lamp shows when energy is or is not being applied.
Energy may be supplied from 120 or 240 V, 50 or 60 Hz main service.
(2)(i) Test flame and pilot flame-regulatable test flame, for
dipping into the sample cup to try for flash, and a pilot flame, to
maintain the test flame, are required. These flames may be fueled by
piped gas service. A gage ring 4mm (5/32 in.) in diameter, engraved on
the lid near the test flame, is required to ensure uniformity in the
size of the test flame.
[[Page 447]]
(ii) Caution: Never recharge the self-contained gas tank at elevated
temperature, or with the pilot or test flames lighted, nor in the
vicinity of other flames.
(iii) Audible Signal is required. The audiable signal is given after
1 min in the case of the low-temperature tester.
(iv) Syringe. 2ml capacity, equipped with a needle suitable for use
with the apparatus, adjusted to deliver 2.000.05 ml.
(3) Essential dimensions of the test apparatus are set forth in
table 3.
(n) Testing high-viscosity liquids. (1) High-viscosity materials may
be added to the cup by the following procedure:
(i) Back load a 5 or 10-ml syringe with the sample to be tested and
extrude 2 ml into the cup. Spread the specimen as evenly as possible
over the bottom of the cup.
(ii) If the sample cannot be loaded into a syringe and extruded,
other means of adding the sample to the cup may be used such as a spoon.
Add approximately 2 ml of material to the spoon and then push the
material from the spoon into the cup.
(iii) If the test specimen does not close the sampling port in the
cup, seal the cup externally by suitable means.
(2) Using the appropriate procedure, either Method A in
Sec. 1500.43a(i) or Method B in Sec. 1500.43a(j), determine the
flashpoint of the specimen which has been added to the tester in
accordance with Sec. 1500.43a(n)(i), except that the time specified is
increased from 1 to 5 minutes for samples at or above ambient
temperature.
Table 1--Calibration of Tester
Material.................................. p-xyleneA (Caution).B
Specific gravity. 15.6/15.6 C (60/60 F)... 0.850 to 0.866.
Boiling range............................. 2 C maximum including 138.35
C (281.03 F).
Freezing point............................ 11.23 C (52.2 F) minimum.
Flashpoint C (acceptable range)........... 25.60.5 (781 []).
A Available as Flash Point Check Fluid (p-xylene) from Special Products
Div., Phillips Petroleum Co., Drawer `O,' Borger, Texas 79007.
B Caution: Handle xylene with care. Avoid inhalation; use only in a well-
ventilated area. Avoid prolonged or repeated contact with skin. Keep
away from flames and heat, except as necessary for the actual flash
point determination.
Table 2--Repeatability and Reproducibility
------------------------------------------------------------------------
Repeatability,
Temperature, C ( F) C ( F) Reproducibility,
C ( F)
------------------------------------------------------------------------
20(68)................................ 0.5(0.9) 1.4(2.6)
70(158)............................... 0.5(0.9) 2.9(5.3)
93(200)............................... 1.3(2.3) 4.9(8.8)
150(300).............................. 2.0(3.6) 7.5(13.5)
200(400).............................. 2.6(4.7) 9.9(17.9)
260(500).............................. 3.3(5.9) 12.4(22.3)
------------------------------------------------------------------------
Table 3--Essential Dimensions of Flash Test Apparatus A, B
Sample Block
Block diameter............................................ 61.5-62.5
Sample well diameter...................................... 49.40-49.70
Sample well depth......................................... 9.70-10.00
Top of block to center of thermometer hole................ 16.00-17.00
Diameter of thermometer hole (approx.).................... 7.0004
Cover
Large opening length...................................... 12.42-12.47
Large opening width....................................... 10.13-10.18
Small opening length...................................... 5.05-5.10
Small opening width....................................... 7.60-7.65
Distance between extreme edges of small openings.......... 48.37-48.32
Filling orifice diameter.................................. 4.00-4.50
Bore or filler tube....................................... 1.80-1.85
Maximum distance of filler tube from base of well with 0.75
cover closed (max.)......................................
Slide
Large opening length...................................... 12.42-12.47
Large opening width....................................... 10.13-10.18
Small opening length...................................... 5.05-5.10
Small opening width....................................... 7.60-7.65
Near edge of large opening to end of slide................ 12.80-12.85
Extremes of large and small openings...................... 30.40-30.45
Jet
Length of jet............................................. 18.30-18.40
External diameter at end of jet........................... 2.20-2.60
Bore of jet............................................... 1.60-1.65
Height of jet center above top surface of cover........... 11.00-11.20
Jet pivot to center of block with cover closed............ 12.68-12.72
A The O-seal or gasket which provides a seal when the cover is shut,
should be made of a heat-resistant material capable of withstanding
temperatures up to 150 C for the low-range apparatus.
B When in position, the thermometer bulb should be surrounded with heat-
conducting thermoplastic compound, such as a paste comprised of zinc
oxide and mineral oil.
[[Page 448]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.054
[51 FR 28539, Aug. 8, 1986]
Sec. 1500.44 Method for determining extremely flammable and flammable solids.
(a) Preparation of samples--(1) Granules, powders, and pastes. Pack
the sample into a flat, rectangular metal boat with inner dimensions 6
inches long x 1 inch wide x one-fourth inch deep.
(2) Rigid and pliable solids. Measure the dimensions of the sample
and support it by means of metal ringstands, clamps, rings, or other
suitable devices as needed, so that the major axis is oriented
horizontally and the maximum surface is freely exposed to the
atmosphere.
(b) Procedure. Place the prepared sample in a draft-free area that
can be ventilated and cleared after each test. The temperature of the
sample at the time of testing shall be between 68 deg.F.
[[Page 449]]
and 86 deg.F. Hold a burning paraffin candle whose diameter is at least
1 inch, so that the flame is in contact with the surface of the sample
at the end of the major axis for 5 seconds or until the sample ignites,
whichever is less. Remove the candle. By means of a stopwatch, determine
the time of combustion with self-sustained flame. Do not exceed 60
seconds. Extinguish flame with a CO2 or similar
nondestructive type extinguisher. Measure the dimensions of the burnt
area and calculate the rate of burning along the major axis of the
sample.
Sec. 1500.45 Method for determining extremely flammable and flammable contents of self-pressurized containers.
(a) Equipment required. The test equipment consists of a base 8
inches wide, 2 feet long, marked in 6-inch intervals. A rule 2 feet long
and marked in inches is supported horizontally on the side of the base
and about 6 inches above it. A paraffin candle 1 inch or more in
diameter, and of such height that the top third of the flame is at the
height of the horizontal rule, is placed at the zero point in the base.
(b) Procedure. The test is conducted in a draft-free area that can
be ventilated and cleared after each test. Place the self-pressurized
container at a distance of 6 inches from the flame source. Spray for
periods of 15 seconds to 20 seconds (one observer noting the extension
of the flame and the other operating the container) through the top
third of the flame and at a right angle to the flame. The height of the
flame should be approximately 2 inches. Take three readings for each
test, and average. As a precaution do not spray large quantities in a
small, confined space. Free space of previously discharged material.
Sec. 1500.46 Method for determining flashpoint of extremely flammable contents of self-pressurized containers.
Use the apparatus described in Sec. 1500.43a. Use some means such as
dry ice in an open container to chill the pressurized container. Chill
the container, the flash cup, and the bath solution of the apparatus
(brine or glycol may be used) to a temperature of about 25 deg.F below
zero. Puncture the chilled container to exhaust the propellant. Transfer
the chilled formulation to the test apparatus and test in accordance
with the method described in Sec. 1500.43a.
[51 FR 28544, Aug. 8, 1986]
Sec. 1500.47 Method for determining the sound pressure level produced by toy caps.
(a) Equipment required. The equipment for the test includes a
microphone, a preamplifier (if required), and an oscilloscope.
(1) The microphone-preamplifier system shall have a free-field
response uniform to within 2 decibels from 50 hertz to 70
kilohertz or beyond and a dynamic range covering the interval 70 to 160
decibels relative to 20 micronewtons per square meters. Depending on the
model, the microphone shall be used at normal or at grazing incidence,
whichever gives the most uniform free-field response. The microphone
shall be calibrated both before and after the test of a model of cap.
The calibration shall be accurate to within 1 decibel. If
the calibration is of the pressure type or of the piston-phone plus
electrostatic actuator type, it shall be corrected to free-field
conditions in accordance with the manufacturer's instructions.
(2) The oscilloscope shall be the storage type or one equipped with
a camera. It shall have a response uniform to within 1
decibel from 50 hertz to 250 kilohertz or higher. It shall be calibrated
to within 1 decibel against an external voltage source
periodically during the tests.
(b) Procedure. (1) Use the type pistol that would ordinarily be used
with the caps being tested. Place the pistol and testing equipment so
that neither the pistol nor the microphone is closer than 1 meter from
any wall, floor, ceiling, or other large obstruction. Locate the pistol
and the microphone in the same horizontal plane with a distance of 25
centimeters between the diaphragm of the microphone and the position of
the explosive. Measure the peak sound pressure level at each of the six
designated orientations of the pistol with respect to the measuring
microphone. The 0 deg. orientation corresponds to the muzzle of the
pistol
[[Page 450]]
pointing at the microphone. The 90 deg., 180 deg., and 270 deg.
orientations are measured in a clockwise direction when looking down on
the pistol with its barrel horizontal, as illustrated by the following
figure:
[GRAPHIC] [TIFF OMITTED] TC03OC91.055
(2) The hammer and trigger orientations are obtained by rotating the
pistol about the axis of the barrel, when the pistol is in the 90 deg.
or 270 deg. orientation, so that the hammer and the trigger are each
respectively closest to and in the same horizontal plane with the
microphone.
(3) Fire 10 shots at each of the six orientations, obtaining
readings on the oscilloscope of the maximum peak voltage for each shot.
Average the results of the 10 firings for each of the six orientations.
(4) Using the orientation that yields the highest average value,
convert the value to sound pressure levels in decibels relative to 20
micronewtons per square meter using the response to the calibrated
measuring microphone.
Sec. 1500.48 Technical requirements for determining a sharp point in toys and other articles intended for use by children under 8 years of age.
(a) Objective. The sharp point test prescribed by paragraph (d) of
this section will be used by the Commission in making a preliminary
determination that points on toys and other articles intended for use by
children under 8 years of age, and such points exposed in normal use or
as a result of reasonably foreseeable damage or abuse of such toys and
articles, present a potential risk of injury by puncture or laceration
under section 2(s) of the Federal Hazardous Substances Act (15 U.S.C.
1261(s)). The Commission will further evaluate points that are
identified as presenting a potential risk of puncture or laceration
injury to determine the need for individual product regulatory action.
(b) Scope--(1) General. The sharp point test of paragraph (d) of
this section is applicable to toys or other articles that are introduced
into interstate commerce on or after December 22, 1978. The sharp point
test shall be applied to any accessible portion of the test sample
before and after subjecting the test sample to the use and abuse tests
of Sec. Sec. 1500.51, 1500.52, and 1500.53 (excluding the bite test-
paragraph (c) of each section).
(2) Exemptions. (i) Toys and other children's articles that are the
subject of any of the following regulations are exempt from this
Sec. 1500.48: The regulations for bicycles, non-full-size baby cribs,
and full-size baby cribs (parts 1508, 1509, and 1512, of this chapter).
(ii) Toys that by reason of their functional purpose necessarily
present the hazard of sharp points and that do not have any
nonfunctional sharp points are exempt from this Sec. 1500.48: Provided,
Each toy is identified by a conspicuous, legible, and visible label at
the time of any sale, as having functional sharp points. An example of
such toys is a toy sewing machine with a needle.
(iii) Articles, besides toys, intended for use by children that by
reason of their functional purpose necessarily present the hazard of
sharp points and that do not have any nonfunctional sharp points are
exempt from this Sec. 1500.48. An example of such articles is a ball-
point pen.
(c) Accessibility--(1) General. Any point that is accessible either
before or after these tests of Sec. Sec. 1500.51, 1500.52, and 1500.53
(excluding the bite test--paragraph (c) of each section) are performed
shall be subject to the sharp point test of paragraph (d) of this
section.
(2) Accessible points. (i) An accessible point for a toy or article
intended for children 3 years of age or less is one that can be
contacted by any portion forward of the collar of the accessibility
probe designated as probe A in figure 2 of this section.
(ii) An accessible point for a toy or article intended for children
over 3 years up to 8 years of age is one that
[[Page 451]]
can be contacted by any portion forward of the collar of the
accessibility probe designated as probe B in figure 2 of this section.
(iii) An accessible point for a toy or article intended for children
of ages spanning both age groups is one that can be contacted by any
portion forward of the collar of either probe A or B, as shown in figure
2 of this section.
(3) Insertion depth for accessibility. (i) For any hole, recess, or
opening having a minor dimension (The minor dimension of an opening is
the diameter of the largest sphere that will pass through the opening.)
smaller than the collar diameter of the appropriate probe, the total
insertion depth for accessibility shall be up to the collar on the
appropriate probe. Each probe joint may be rotated up to 90 degrees to
simulate knuckle movement.
(ii) For any hole, recess, or opening having a minor dimension
larger than the collar diameter of probe A but less than 7.36 inches
(186.9 millimeters), when probe A is used, or a minor dimension larger
than the collar diameter of probe B but less than 9.00 inches (228.6
millimeters), when probe B is used, the total insertion depth for
accessibility shall be determined by inserting the appropriate probe
with the extension shown in figure 2 in any direction up to two and one-
quarter times the minor dimension of the probe, recess, or opening,
measured from any point in the plane of the opening. Each probe joint
may be rotated up to 90 degrees to simulate knuckle movement.
(iii) For any hole, recess, or opening having a minor dimension of
7.36 inches (186.9 millimeters) or larger when probe A is used, or a
minor di-mension of 9.00 inches (228.6 millimeters), or larger when
probe B is used, the total insertion depth for accessibility is
unrestricted unless other holes, recesses, or openings within the
original hole, recess, or opening are encountered with dimensions
specified in paragraph (c)(3) (i) or (ii) of this section. In such
instances, the appropriate paragraphs (c)(3) (i) or (ii) of this section
shall be followed. If both probes are to be used, a minor dimen-sion
that is 7.36 inches (186.9 millimeters or larger shall determine
unrestricted access.
(4) Inaccessible points. Points shall be considered inaccessible
without testing with a probe if they lie adjacent to a surface of the
test sample and any gap between the point and the adjacent surface does
not exceed 0.020 inch (0.50 millimeter) either before or after the tests
of Sec. Sec. 1500.51, 1500.52, and 1500.53 (excluding the bite test--
paragraph (c) of each section) are performed.
(d) Sharp point test method--(1) Principle of operation. The
principle of operation of the sharp point tester shown in figure 1 of
this section is as follows (Detailed engineering drawings for a
suggested sharp point tester are available from the Commission's Office
of the Secretary.): A rectangular opening measuring 0.040 inch (1.02
millimeters) wide by 0.045 inch (1.15 millimeters) long in the end of
the slotted cap establishes two reference dimensions. Depth of
penetration of the point being tested determines sharpness. If the point
being tested can contact a sensing head that is recessed a distance of
0.015 inch (0.38 millimeter) below the end cap and can move the sensing
head a further 0.005 inch (0.12 millimeter) against a 0.5-pound (2.2-
newton) force of a return spring, the point shall be identified as
sharp. A sharp point tester of the general configuration shown in figure
1 of this section or one yielding equivalent results shall identify a
sharp point. In conducting tests to determine the presence of sharp
points, the Commission will use the sharp point tester shown in figure 1
of this section and the accessibility probes designated as A or B in
figure 2 of this section.
(2) Procedure. (i) The sample to be tested shall be held in such a
manner that it does not move during the test.
(ii) Part of the test sample may need to be removed to allow the
sharp point testing device to test a point that is accessible by the
criteria of paragraph (c) of this section. Such dismantling of the test
sample could affect the rigidity of the point in question. The sharp
point test shall be performed with the point supported so that its
stiffness approximates but is not greater than the point stiffness in
the assembled sample.
(iii) Using the general configuration shown in figure 1 of this
section, the adjustment and operation of the sharp
[[Page 452]]
point tester is as follows: Hold the sharp point tester and loosen the
lock ring by rotating it so that it moves towards the indicator lamp
assembly a sufficient distance to expose the calibration reference marks
on the barrel. Rotate the gaging can clockwise until the indicator lamp
lights. Rotate the cap counterclockwise until an equivalent of five
divisions (the distance between the short lines on the cap) have passed
the calibration reference mark. Lock the gaging cap in this position by
rotating the lock ring until it fits firmly against the cap. Insert the
point into the gaging slot in all directions in which it was accessible
by the criteria of paragraph (c) of this section, and apply a force of
1.00 pound (4.45 newtons). A glowing light identifies the point as
sharp.
(iv) The test instruments used by the Commission in its tests for
compliance with this regulation shall have gaging slot opening
dimensions no greater than 0.040 inch by 0.045 inch and shall have the
sensing head recessed a depth of no less than 0.015 inch. The force
applied by the Commission when inserting a point into the gaging slot
shall be no more than 1.00 pound.
(e) For the purpose of conformance with the technical requirements
prescribed by this Sec. 1500.48, the English figures shall be used. The
metric approximations are provided in parentheses for convenience and
information only.
[[Page 453]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.056
Sec. 1500.49 Technical requirements for determining a sharp metal or glass edge in toys and other articles intended for use by children under 8 years of age.
(a) Objective. The sharp edge test method prescribed by paragraph
(d) of this section will be used by the Commission in making a
preliminary determination that metal or glass edges on toys and other
articles intended for use by children under 8 years of age, and such
edges exposed in normal use or as a result of reasonably forseeable
damage or abuse of such toys and articles, present a potential risk of
injury by
[[Page 454]]
laceration or avulsion under section 2(s) of the Federal Hazardous
Substances Act (15 U.S.C. 1261(s)). The Commission will further evaluate
toys and other articles with edges that are identified as presenting a
potential risk of laceration or avulsion injury to determine the need
for individual product regulation.
(b) Scope--(1) General. The sharp edge test of paragraph (d) of this
section is applicable to toys or other articles containing metal or
glass edges that are introduced into interstate commerce after March 26,
1979. Such articles manufactured outside the United States are
introduced into interstate commerce when first brought within as U.S.
port of entry. Such articles manufactured in the United States are
introduced into interstate commerce (a) at the time of first interstate
sale, or (b) at the time of first intrastate sale if one or more
components and/or raw materials were received interstate, whichever
occurs earlier.
(2) Exemptions. (i) Toys and other children's articles that are the
subject of any of the following regulations are exempt from this
Sec. 1500.49: The regulations for bicycles, non-full-size baby cribs,
and full-size baby cribs (parts 1508, 1509, and 1512 of this chapter).
(ii) Toys that by reason of their functional purpose necessarily
present the hazard of sharp metal or glass edges and that do not have
any nonfunctional sharp metal or glass edges are exempt from this
section: Provided, the toy is identified by a conspicuous, legible, and
visible label at the time of any sale, as having functional sharp metal
or glass edges. Examples of these are a pair of toy scissors and toy
tool kits.
(iii) Articles, besides toys, intended for use by children that by
reason of their functional purpose necessarily present the hazard of
sharp metal or glass edges and that do not have any non-functional sharp
metal or glass edges are exempt from this section. Examples of these are
children's ice skates and children's cutlery.
(3) Definitions--(i) Glass. For the purpose of this regulation the
Commission defines glass as a hard, brittle, amorphous substance
produced by fusion, usually consisting of mutually dissolved silica and
silicates that also contain soda and lime.
(ii) Metal. For the purpose of this regulation the Commission
intends the word metal to include both elemental metals and metal
alloys.
(c) Accessibility--(1) General. Any metal or glass edge that is
accessible either before or after the test of Sec. Sec. 1500.51,
1500.52, and 1500.53 (excluding the bite test--paragraph (c) of each
section) are performed shall be subject to the sharp edge test of
paragraph (d) of this section. Toys reasonably intended to be assembled
by an adult and not intended to be taken apart by a child shall be
tested only in the assembled state if the shelf package and the assembly
instructions prominently indicate that the article is to be assembled
only by an adult.
(2) Accessible edges. (i) An accessible metal or glass edge for a
toy or article intended for children 3 years of age or less is one that
can be contacted by any portion forward of the collar of the
accessibility probe designated as probe A in Figure 2 of this section.
(ii) An accessible edge for a toy or article intended for children
over 3 years and up to 8 years of age is one that can be contacted by
any portion forward of the collar of the accessibility probe designated
as Probe B in Figure 2 of this section.
(iii) An accessible edge for a toy or article intended for children
of ages spanning both age groups is one that can be contacted by any
portion forward of the collar of either Probe A or Probe B, as shown in
Figure 2 of this section.
(3) Insertion depth. (i) For any hole, recess, or opening having a
minor dimension (the minor dimension of an opening is the diameter of
the largest sphere that will pass through the opening), smaller than the
collar diameter of the appropriate probe, the total insertion depth for
accessibility shall be up to the collar on the appropriate probe. Each
probe joint may be rotated up to 90 degrees to simulate knuckle
movement.
(ii) For any hole, recess, or opening having a minor dimension
larger than the collar diameter of Probe A, but less than 7.36 inches
(186.9 millimeters),
[[Page 455]]
when Probe A is used, or a minor dimension larger than the collar
diameter of Probe B, but less than 9.00 inches (228.6 millimeters), when
Probe B is used, the total insertion depth for accessibility shall be
determined by inserting the appropriate probe with the extension, shown
in Figure 2, in any direction up to 2\1/4\ times the minor dimension of
the hole, recess, or opening, measured from any point in the plane of
the opening. Each probe joint may be rotated up to 90 degrees to
simulate knuckle movement.
(iii) For any hole, recess, or opening having a minor dimension of
7.36 inches (186.9 millimeters) or larger when Probe A is used, or a
minor dimension of 9.00 inches (228.6 millimeters) or larger when Probe
B is used, the total insertion depth for accessibility is unrestricted
unless other holes, recesses, or openings within the original hole,
recess, or opening are encountered with dimensions specified in
paragraph (c)(3) (i) or (ii) of this section. In such instances, the
appropriate paragraphs (c)(3) (i) or (ii) of this section shall be
followed. If both probes are to be used, a minor dimension that is 7.36
inches (186.9 millimeters or larger shall determine unrestricted access.
(4) Inaccessible edges. Metal or glass edges shall be considered
inaccessible without testing with a probe if they lie adjacent to a
surface of the test sample, and any gap between the edge and the
adjacent surface does not exceed 0.020 inch (0.50 millimeter) both
before and after the tests of Sec. Sec. 1500.51, 1500.52, and 1500.53
(excluding the bite test--paragraph (c) of each section) are performed.
For example, in a lap joint in which a metal edge is overlapped by a
parallel surface, any burr or feather-edge on the side closest to the
protecting parallel surface is considered inaccessible if the gap
between the edge and the parallel surface is no greater than 0.020 inch
(0.50 millimeter). As an additional example, when sheet metal has a
hemmed edge a portion of the sheet adjacent to the edge is folded back
upon itself, approximately 180 degrees, so that it is roughly parallel
to the main sheet. Any burrs or feathering on the inside edge, the side
closest to the protecting parallel surface of the main sheet, will be
considered inaccessible if the gap between the inside edge and the
parallel surface does not exceed 0.020 inch (0.50 millimeter).
(d) Sharp edge test method--(1) Principle of operation. The test
shall be performed with a sharp edge tester which contains a cylindrical
mandrel capable of rotation at a constant velocity. (Engineering
drawings for a suitable portable sharp edge test instrument are
available from the Commission's Office of the Secretary.) The full
circumference of the mandrel shall be wrapped with a single layer of
polytetrafluoroethylene (TFE) tape as specified in paragraph (e)(3) of
this section. The mandrel shall be applied to the edge to be tested with
a normal force of 1.35 pounds (6.00 Newtons) such that the edge contacts
the approximate center of the width of the tape as shown in Figure 1 of
this section. The mandrel shall be rotated through one complete
revolution while maintaining the force against the edge constant. Linear
motion of the mandrel along the line of the edge shall be prevented. The
edge shall be identified as sharp if it completely cuts through the tape
for a length of not less than \1/2\ inch (13 millimeters) at any force
up to 1.35 pounds (6.00 Newtons).
(2) Procedure. (i) The edge of the sample to be tested shall be held
in such a manner that it does not move during the test. If the full
mandrel force of 1.35 pounds (6.00 Newtons) causes the edge to bend, a
reduced mandrel force may be used.
(ii) Part of the test sample may need to be removed to allow the
sharp edge testing device to test an edge that is accessible by the
criteria of paragraph (c) of this section. Such dismantling of the test
sample could affect the rigidity of the edge in question. The sharp edge
test shall be performed with the edge supported so that its stiffness
approximates but is not greater than the edge stiffness in the assembled
sample.
(iii) Conduct of a sharp edge test is as follows: Wrap one layer of
polytetrafluoroethylene (TFE) tape, described in paragraph (e)(3) of
this section, around the full circumference of the mandrel in an
unstretched state. The ends of
[[Page 456]]
the tape shall be either butted or overlapped not more than 0.10 inch
(2.5 millimeters). Apply the mandrel, at the approximate center of the
tape, to the edge of the test sample with a force of 1.35 pounds (6.00
Newtons) measured in a direction at right angles to the mandrel axis.
The mandrel shall be placed so that its axis is at 90 degrees
5 degrees to the line of a straight test edge or 90 degrees
5 degrees to a tangent at the point of contact with a curved
test edge. The point of contact between the test edge and the mandrel
shall be in the approximate center of the width of the tape. The axis of
the mandrel may be positioned anywhere in a plane which is at right
angles to either the line of a straight test edge or to a tangent at the
point of contact with a curved test edge. The operator should seek the
orientation most likely to cause the edge to cut the tape. Maintain the
force against the edge and rotate the mandrel through one complete
revolution while preventing any linear motion of the mandrel along the
edge. Release the mandrel from the edge and remove the tape without
enlarging any cut or causing any score to become a cut. A cut in the
tape with a length of not less than \1/2\ inch (13 millimeters)
identifies an edge as sharp. (The test instruments used by the
Commission in its test for compliance with the regulation will be
calibrated to insure that the force with which the mandrel is applied to
a test edge does not exceed 1.35 pounds.)
(e) Specifications for sharp edge test equipment. The following
specifications shall apply to the equipment to be used in the sharp edge
test described in paragraph (d) of this section:
(1) The rotation of the mandrel shall produce a constant tangential
velocity of 1.000.08 inch per second (25.42.0
millimeters per second) during the center 75 percent of its rotation and
shall have a smooth start and stop.
(2) The mandrel shall be made of steel. The test surface of the
mandrel shall be free of scratches, nicks, or burrs and shall have a
surface roughness no greater than 16 microinches (0.40 micron). The test
surface shall have a hardness no less than 40 as measured on the
Rockwell ``C'' scale, as determined pursuant to ASTM E 18-74 entitled
``Standard Test Methods for Rockwell Hardness and Rockwell Superficial
Hardness of Metallic Materials,'' published July 1974 and which is
incorporated by reference in this regulation. (Copies are available from
American Society for Testing and Materials, 1916 Race Street,
Philadelphia, Pa. 19103.) The diameter of the mandrel shall be
0.3750.005 inch (9.350.12 millimeters). The
mandrel shall be of suitable length to carry out the test.
(3) The tape shall be pressure-sensitive polytetrafluoroethylene
(TFE) high temperature electrical insulation tape as described in
Military Specification MIL-I-23594B (1971) which is incorporated by
reference in this regulation. (Copies are available from Naval
Publications and Forms Center, 5801 Tabor Ave., Philadelphia, Pa.
19120.) The thickness of the polytetrafluoroethylene backing shall be
between 0.0026 inch (0.066 millimeter) and 0.0035 inch (0.089
millimeter).\1\ The adhesive shall be pressure-sensitive silicone
polymer with a nominal thickness of 0.003 inch (.08 millimeter). The
width of the tape shall not be less than \1/4\ inch (6 millimeters).
While conducting sharp edge tests the temperature of the tape shall be
maintained between 70 deg.F (21.1 deg.C) and 80 deg.F (26.6 deg.C).
---------------------------------------------------------------------------
\1\ The tape that the Commission will use for the sharp edge test is
CHR type ``T'' manufactured by The Connecticut Hard Rubber Co., New and
East Streets, New Haven, Conn. 06509.
---------------------------------------------------------------------------
(f) For the purpose of conformance with the technical requirements
prescribed by this Sec. 1500.49, the English figures shall be used. The
metric approximations are provided in parentheses for convenience and
information only.
[[Page 457]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.057
[[Page 458]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.058
(Secs. 2(s), 10(a), 74 Stat. 378 (15 U.S.C. 1261, 1269))
[43 FR 12645, Mar. 24, 1978, as amended at 43 FR 21324, May 17, 1978]
Sec. 1500.50 Test methods for simulating use and abuse of toys and other articles intended for use by children.
(a) Objective. The objective of Sec. Sec. 1500.51, 1500.52, and
1500.53 is to describe specific test methods for simulating normal use
of toys and other articles intended for use by children as well as the
reasonably foreseeable damage or abuse to which the articles may be
subjected. The test methods are for use in exposing potential hazards
that would result from the normal use or the reasonably foreseeable
damage or abuse of such articles intended for children.
(b) Application--general. (1)(i) The test methods described in
Sec. Sec. 1500.51, 1500.52 and 1500.53 are to be used in determining
what is normal use and reasonably foreseeable damage or abuse when
specifically referenced under Sec. 1500.18. Other banning regulations
may also reference these use and abuse toy test procedures.
(ii) The test methods described in Sec. Sec. 1500.51, 1500.52, and
1500.53 have been established for articles intended for the specified
age groups of children: 18 months of age or less, over 18 months but not
over 36 months of age, and over 36 months but not over 96 months of age.
If an article is marked, labeled,
[[Page 459]]
advertised, or otherwise intended for children of ages spanning more
than one of these age groups, the article will be subjected to the tests
providing the most stringent requirements. If an article is not age-
labeled in a clear and conspicuous manner or, based on such factors as
marketing practices and the customary patterns of usage of a product by
children, is inappropriately age-labeled, and is intended or appropriate
for children 96 months of age or less, it will also be subjected to the
most stringent test requirements.
(2) For purposes of compliance with the test methods prescribed in
Sec. Sec. 1500.51, 1500.52, and 1500.53, the English system shall be
used. The metric approximations are provided in parentheses for
convenience and information only.
(3) Each of the test methods described in Sec. Sec. 1500.51,
1500.52, and 1500.53 shall be applied to a previously untested sample
except the tension test which shall be conducted with the test sample
used in the torque test.
(4) Prior to testing, each sample shall be subjected to a
temperature of 73 deg.3 deg.F. (23 deg.2
deg.C.) as a relative humidity of 20-70 percent for a period of at least
4 hours. The toy testing shall commence within five minutes after the
toy has been removed from the preconditioning atmosphere.
(5) Toys reasonably intended to be assembled by an adult and not
intended to be taken apart by a child shall be tested only in the
assembled state if the shelf package and the assembly instructions
prominently indicate that the article is to be assembled only by an
adult.
(6) Toys intended to be repeatedly assembled and taken apart shall
have the individual pieces as well as the completed article subjected to
these test procedures.
(7) In situations where a test procedure may be applied in more than
one way to a toy test component, the point (or direction) of force (or
torque) application which results in the most severe conditions shall be
used.
(c) Definitions. As used in this section and in Sec. Sec. 1500.51,
1500.52, and 1500.53:
(1) Toy means any toy, game, or other article designed, labeled,
advertised, or otherwise intended for use by children.
(2) Mouth toy means any toy reasonably intended to be placed into or
in contact with a child's mouth.
[40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. 10, 1975]
Sec. 1500.51 Test methods for simulating use and abuse of toys and other articles intended for use by children 18 months of age or less.
(a) Application. The test methods described in this section shall be
used to simulate the normal and reasonably foreseeable use, damage, or
abuse of toys and other articles intended for use by children 18 months
of age or less in conjunction with Sec. 1500.18.
(b) Impact test--(1) Application. Except as provided in paragraph
(b)(4) of this section, toys having a weight of less than 3.0 pounds
0.01 pound (1.4 kilograms) shall be subject to this test.
(2) Impact medium. The impact medium shall consist of a \1/8\-inch
(0.3-centimeter) nominal thickness of type IV vinyl-composition tile,
composition 1--asbestos free, as specified by paragraphs 1.2 and 3.1.4
of Interim Amendment-1(YD), dated November 14, 1979, to the Federal
Specification entitled Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-
Asbestos, SS-T-312B, dated October 10, 1974,\1\ over at least a 2.5-inch
(6.4-centimeter) thickness of concrete. The impact area shall be at
least 3 square feet (0.3 square meter). The Commission recognizes that
this specified impact medium is the equivalent of, and will yield the
same impact test results as, a surface covered with vinyl-asbestos tile
meeting the requirements of Federal Specification SS-T-312A.
---------------------------------------------------------------------------
\1\ These documents may be ordered from the General Services
Administration, Specifications Unit, Room 6654, 7th and D Streets, S.W.,
Washington, DC 20407. The price of the specification and amendment is
$1.00.
---------------------------------------------------------------------------
(3) Testing procedure. Except as provided in paragraphs (b)(4) (i)
and (ii) of this section, the toy shall be dropped 10 times from a
height of 4.5 feet 0.5 inch (1.37 meters) onto the impact
medium described in paragraph (b)(2) of this section. The toy shall be
dropped in random orientation. After each drop,
[[Page 460]]
the test sample shall be allowed to come to rest and shall be examined
and evaluated before continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area
of 400 or more square inches (2,560 or more square centimeters), shall
be tested for impact in accordance with paragraph (b)(4)(iii) of this
section. The base area for toys with permanently attached legs shall be
measured by calculating the area enclosed by straight lines connecting
the outermost edge of each leg of the perimeter.
(ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic
meter), calculated by the major dimensions without regard to minor
appendages, shall be tested for impact in accordance with paragraph
(b)(4)(iii) of this section.
(iii) The toys described in paragraph (b)(4)(i) and (ii) of this
section shall be tested for impact by tipping them over three times by
pushing the samples slowly past their centers of balance onto the impact
medium described in paragraph (b)(2) of this section.
(c) Bite test--(1) Application. A toy (or component or any
accessible portion thereof) that has an external dimension of 1.25
inches 0.05 inch (3.18 centimeters) or less and a design
configuration that would permit a child to insert a portion into the
mouth in any orientation up to a biting thickness of 1.25 inches
0.05 inch (3.18 centimeters), for a penetration of at least
0.25 inch (0.635 centimeter), shall be subject to this test.
(2) Test equipment--(i) Contact mechanism. The contact mechanism
shall be two metal strips or plates each measuring 0.25 inch
0.002 inch (0.635 centimeter) high and each having a contact
edge radius of 0.020 inch 0.002 inch (0.05 centimeter), for
at least a 150-degree cross-sectional arc. A suggested contact mechanism
appears in figure 1 of this section.
(ii) Loading device. The loading device shall be a scale or force
gauge having an accuracy of 0.5 pound (225
grams).
(3) Testing procedure. The test article shall be placed in the
contact mechanism in any reasonable position for a penetration of 0.25
to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less
than 180 degrees of the arc of the contact mechanism, and a test load
increasing to 25 pounds 0.5 pound (11.35 kilograms) shall be
evenly applied within 5 seconds. This load shall be maintained for an
additional 10 seconds.
(d) Flexure test--(1) Application. This test shall be applied to
each component of a toy containing metal wire(s), or other metal
material(s), for stiffening or for retention of form if the component
can be bent through a 60-degree arc by a maximum force of 10 pounds
0.5 pound (4.55 kilograms), applied perpendicularly to the
major axis of the component at a point 2 inches (5 centimeters) from the
intersection of the component with the main body of the toy or at the
end of the component if the component is less than 2 inches
0.05 inch (5 centimeters) long.
(2) Testing procedure. The toy shall be secured in a vise equipped
with vise shields that are fabricated from 13-gauge cold-rolled steel or
other similar material and that have a 0.375-inch (0.95-centimeter)
inside radius. The component shall then be bent through a 60-degree arc
by a force applied at a point on the component 2 inches 0.05
inch (5 centimeters) from the intersection of the component with the
main body of the toy or applied at the end of the component if the
component is less than 2 inches (5 centimeters) long. The component
shall then be bent in the reverse direction through a 120-degree arc.
This process shall be repeated for 30 cycles at a rate of one cycle per
two seconds with a 60-second rest period occurring after each 10 cycles.
Two 120-degree arc bends shall constitute one cycle.
(e) Torque test--(1) Application--(i) General. A toy with a
projection, part, or assembly that a child can grasp with at least the
thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or
assemblies that are rigidly mounted on an accessible rod or shaft
designed to rotate along with the projections, parts, or assemblies
shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment--(i) Loading device. The loading device shall be
a torque gauge, torque wrench, or other appropriate device having an
accuracy of 0.2
[[Page 461]]
inch-pound (0.23 kilogram-centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component
firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any
reasonable test position, the clamp is fastened to the test object or
component. A torque of 2 inch-pounds 0.2 inch-pound (2.30
kilogram-centimeters) shall be applied evenly within a period of 5
seconds in a clockwise direction until a rotation of 180 degrees from
the original position has been attained or 2 inch-pounds (2.30 kilogram-
centimeters) exceeded. The torque or maximum rotation shall be
maintained for an additional 10 seconds. The torque shall then be
removed and the test component permitted to return to a relaxed
condition. This procedure shall then be repeated in a counterclockwise
direction.
(f) Tension test--(1) Application--(i) General. Any projection of a
toy that the child can grasp with at least the thumb and forefinger or
the teeth shall be subject to this test. This test is to be conducted on
the same toy that has been subjected to the torque test described in
paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed
of pliable materials having seams (such as fabrics) shall have the seams
subjected to 10 pounds 0.5 pound (4.55 kilograms) of force
applied in any direction.
(2) Test equipment--(i) Clamps. One clamp capable of applying a
tension load to the test component is required. A second clamp suitable
for applying a tension load perpendicularly to the major axis of the
test component is also required.
(ii) Loading device. The loading device is to be a self-indicating
gauge or other appropriate means having an accuracy of 0.5
pound (225 grams).
(3) Testing procedure. With the test sample fastened in a convenient
position, an appropriate clamp shall be attached to the test object or
component. A 10-pound 0.5 pound (4.55-kilogram) direct force
shall be evenly applied, within a period of 5 seconds, parallel to the
major axis of the test component and maintained for an additional 10
seconds. The tension clamp shall then be removed and a second clamp
appropriate for pulling at 90 degrees shall be attached to the test
object or component. A 10-pound 0.5 pound (4.55-kilogram)
tensile force shall be evenly applied, within a period of 5 seconds,
perpendicularly to the major axis of the test component and maintained
for an additional 10 seconds.
(g) Compression test--(1) Application. Any area on the surface of a
toy that is accessible to a child and inaccessible to flat-surface
contact during the impact test shall be subject to this test.
(2) Test apparatus. The loading device shall be a rigid metal disc
1.125 inches 0.015 inch (2.86 centimeters) in diameter and
0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc
shall be rounded to a radius of \1/32\ inch (0.08 centimeter) to
eliminate irregular edges. The disc shall be attached to an appropriate
compression scale having an accuracy of 0.5 pound
(225 grams).
(3) Testing procedure. The disc shall be positioned so that the
contact surface is parallel to the surface under test. A direct force of
20 pounds 0.5 pound (9.1 kilograms) shall be evenly applied
within 5 seconds through the disc. This load shall be maintained for an
additional 10 seconds. During the test the toy is to rest on a flat,
hard surface in any convenient position.
[[Page 462]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.059
[40 FR 1484, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr.
10, 1975; 40 FR 17746, Apr. 22, 1975; as amended at 55 FR 52040, Dec.
19, 1990; 56 FR 9, Jan. 2, 1991; 56 FR 558, Jan. 7, 1991]
Sec. 1500.52 Test methods for simulating use and abuse of toys and other articles intended for use by children over 18 but not over 36 months of age.
(a) Application. The test methods described in this section, shall
be used to simulate the normal and reasonably foreseeable use, damage,
or abuse of toys and other articles intended for use by children over 18
but not over 36 months of age in conjunction with Sec. 1500.18.
(b) Impact test--(1) Application. Except as provided in paragraph
(b)(4) of this section, toys having a weight of less than 4.0 pounds
0.01 pound (1.8 kilograms) shall be subject to this test.
[[Page 463]]
(2) Impact medium. The impact medium shall consist of a \1/8\-inch
(0.3-centimeter) nominal thickness of type IV vinyl-composition tile,
composition 1--asbestos free, as specified by paragraphs 1.2 and 3.1.4
of Interim Amendment-1(YD), dated November 14, 1979, to the Federal
Specification entitled Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-
Asbestos, SS-T-312B, dated October 10, 1974,\1\ over at least a 2.5-inch
(6.4-centimeter) thickness of concrete. The impact area shall be at
least 3 square feet (0.3 square meter). The Commission recognizes that
this specified impact medium is the equivalent of, and will yield the
same impact test results as, a surface covered with vinyl-asbestos tile
meeting the requirements of Federal Specification SS-T-312A.
---------------------------------------------------------------------------
\1\ See footnote 1 to Sec. 1500.51.
---------------------------------------------------------------------------
(3) Testing procedure. Except as provided in paragraph (b)(4) (i)
and (ii) of this section, the toy shall be dropped four times from a
height of 3 feet 0.5 inch (0.92 meter) onto the impact
medium described in paragraph (b)(2) of this section. The toy shall be
dropped in random orientation. After each drop, the test sample shall be
allowed to come to rest and shall be examined and evaluated before
continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area
of 400 or more square inches (2,560 or more square centimeters) shall be
tested for impact in accordance with paragraph (b)(4)(iii) of this
section. The base area for toys with permanently attached legs shall be
measured by calculating the area enclosed by straight lines connecting
the outermost edge of each leg of the perimeter.
(ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic
meter), calculated by the major dimensions without regard to minor
appendages, shall be tested for impact in accordance with paragraph
(b)(4)(iii) of this section.
(iii) The toys described in paragraph (b)(4) (i) and (ii) of this
section shall be tested for impact by tipping them over three times by
pushing the samples slowly past their centers of balance onto the impact
medium described in paragraph (b)(2) of this section.
(c) Bite test--(1) Application. A toy (or component or any
accessible portion thereof) that has an external dimension of 1.25
inches 0.05 inch (3.18 centimeters) or less and a design
configuration that would permit a child to insert a portion into the
mouth in any orientation up to a biting thickness of 1.25 inches
0.05 inches (3.18 centimeters), for a penetration of at
least 0.25 inch (0.635 centimeter), shall be subject to this test.
(2) Test equipment--(i) Contact mechanism. The contact mechanism
shall be two metal strips or plates each measuring 0.25 inch
0.002 inch (0.635 centimeter) high and each having a contact
edge radius of 0.020 inch 0.002 inch (0.05 centimeter) for
at least a 150-degree cross-sectional arc. A suggested contact mechanism
appears in figure 1 of Sec. 1500.51.
(ii) Loading device. The loading device shall be a scale or force
gauge having an accuracy of 0.5 pound (225
grams).
(3) Testing procedure. The test article shall be placed in the
contact mechanism in any reasonable position for a penetration of 0.25
to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less
than 180 degrees of the arc of the contact mechanism, and a test load
increasing to 50 pounds 0.5 pound (22.74 kilograms) shall be
evenly applied within 5 seconds. This load shall be maintained for an
additional 10 seconds.
(d) Flexure test--(1) Application. This test shall be applied to
each component of a toy containing metal wire(s), or other metal
material(s), for stiffening or for retention of form if the component
can be bent through a 60-degree arc by a maximum force of 15 pounds
0.5 pound (6.80 kilograms) applied perpendicularly to the
major axis of the component at a point 2 inches 0.05 inch (5
centimeters) from the intersection of the component with the main body
of the toy or at the end of the component if the component is less than
2 inches 0.05 inch (5 centimeters) long.
(2) Testing procedure. The toy shall be secured in a vise equipped
with vise shields that are fabricated from 13-gauge cold-rolled steel or
other similar material and that have a 0.375-inch (0.95-centimeter)
inside radius. The
[[Page 464]]
component shall then be bent through a 60-degree arc by a force applied
at a point on the component 2 inches 0.05 inch (5
centimeters) from the intersection of the component with the main body
of the toy or applied at the end of the component if the component is
less than 2 inches (5 centimeters) long. The component shall then be
bent in the reverse direction through a 120-degree arc. This process
shall be repeated for 30 cycles at a rate of one cycle per two seconds
with a 60-second rest period occurring after each 10 cycles. Two 120-
degree arc bends shall constitute one cycle.
(e) Torque test--(1) Application--(i) General. A toy with a
projection, part, or assembly that a child can grasp with at least the
thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or
assemblies that are rigidly mounted on an accessible rod or shaft
designed to rotate along with the projections, parts, or assemblies
shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment--(i) Loading device. The loading device shall be
a torque gauge, torque wrench, or other appropriate device having an
accuracy of 0.2 inch-pound (0.23 kilogram-
centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component
firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any
reasonable test position, the clamp is fastened to the test object or
component. A torque of 3 inch-pounds 0.2 inch-pound (3.46
kilogram-centimeters) shall be applied evenly within a period of 5
seconds in a clockwise direction until a rotation of 180 degrees from
the original position has been attained or 3 inch-pounds 0.2
inch-pound (3.46 kilogram-centimeters) exceeded. The torque or maximum
rotation shall be maintained for an additional 10 seconds. The torque
shall then be removed and the test component permitted to return to a
relaxed condition. This procedure shall then be repeated in a
counterclockwise direction.
(f) Tension test--(1) Application--(i) General. Any projection of a
toy that the child can grasp with at least the thumb and forefinger or
the teeth shall be subject to this test. This test is to be conducted on
the same toy that has been subjected to the torque test described in
paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed
of pliable materials having seams (such as fabrics) shall have the seams
subjected to 15 pounds 0.5 pound (6.80 kilograms) of force
applied in any direction.
(2) Test equipment--(i) Clamps. One clamp capable of applying a
tension load to the test component is required. A second clamp suitable
for applying a tension load perpendicularly to the major axis of the
test component is also required.
(ii) Loading device. The loading device is to be a self-indicating
gauge or other appropriate means having an accuracy of 0.5
pound (255 grams).
(3) Testing procedure. With the test sample fastened in a convenient
position, an appropriate clamp shall be attached to the test object or
component. A 15-pound 0.5 pound (6.80-kilogram) direct force
shall be evenly applied, within a period of 5 seconds, parallel to the
major axis of the test component and maintained for an additional 10
seconds. The tension clamp shall then be removed and a second clamp
appropriate for pulling at 90 degrees shall be attached to the test
object or component. A 15-pound 0.5 pound (6.80-kilogram)
tensile force shall be evenly applied, within a period of 5 seconds,
perpendicularly to the major axis of the test component and maintained
for an additional 10 seconds.
(g) Compression test--(1) Application. Any area on the surface of a
toy that is accessible to a child and inaccessible to flat-surface
contact during the impact test shall be subject to this test.
(2) Test apparatus. The loading device shall be a rigid metal disc
1.125 inches 0.015 inch (2.86 centimeters) in diameter and
0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc
shall be rounded to a radius of \1/32\ inch (0.08 centimeter) to
eliminate irregular edges. The disc shall be attached to an appropriate
compression scale having an accurancy of 0.5 pound
(225 grams).
(3) Testing procedure. The disc shall be positioned so that the
contact surface
[[Page 465]]
is parallel to the surface under test. A direct force of 25 pounds
0.5 pound (11.4 kilograms) shall be evenly applied within 5
seconds through the disc. This load shall be maintained for an
additional 10 seconds. During the test the toy is to rest on a flat,
hard surface in any convenient position.
[40 FR 1485, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr.
10, 1975; as amended at 56 FR 10, Jan. 2, 1991]
Sec. 1500.53 Test methods for simulating use and abuse of toys and other articles intended for use by children over 36 but not over 96 months of age.
(a) Application. The test methods described in this section shall be
used to simulate the normal and reasonably foreseeable use, damage, or
abuse of toys and other articles intended for use by children over 36
but not over 96 months of age in conjunction with Sec. 1500.18.
(b) Impact test--(1) Application. Except as provided in paragraph
(b)(4) of this section, toys having a weight of less than 10.0 pounds
0.01 pound (4.6 kilograms) shall be subject to this test.
(2) Impact medium. The impact medium shall consist of a \1/8\-inch
(0.3-centimeter) nominal thickness of type IV vinyl-composition tile,
composition 1--asbestos free, as specified by paragraphs 1.2 and 3.1.4
of Interim Amendment-1(YD), dated November 14, 1979, to the Federal
Specification entitled Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-
Asbestos, SS-T-312B, dated October 10, 1974,\1\ over at least a 2.5-inch
(6.4-centimeter) thickness of concrete. The impact area shall be at
least 3 square feet (0.3 square meter). The Commission recognizes that
this specified impact medium is the equivalent of, and will yield the
same impact test results as, a surface covered with vinyl-asbestos tile
meeting the requirements of Federal Specification SS-T-312A.
(3) Testing procedure. except as provided in paragraph (b)(4) (i)
and (ii) of this section, the toy shall be dropped four times from a
height of 3 feet 0.5 inch (0.92 meter) onto the impact
medium described in paragraph (b)(2) of this section. The toy shall be
dropped in random orientation. After each drop, the test sample shall be
allowed to come to rest and shall be examined and evaluated before
continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area
of 400 or more square inches (2,560 or more square centimeters) shall be
tested for impact in accordance with paragraph (b)(4)(iii) of this
subsection. The base area for toys having permanently attached legs
shall be measured by calculating the area enclosed by straight lines
connecting the outermost edge of each leg of the perimeter.
(ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic
meter), calculated by the major dimensions without regard to minor
appendages, shall be tested for impact in accordance with paragraph
(b)(4)(iii) of this section.
(iii) The toys described in paragraph (b)(4) (i) and (ii) of this
section shall be tested for impact by tipping them over three times by
pushing the samples slowly past their centers of balance onto the impact
medium described in paragraph (b)(2) of this section.
(c) Bite test--(1) Application. A toy (or component) that is a mouth
toy shall be subject to this test.
(2) Test equipment--(i) Contact mechanism. The contact mechanism
shall be two metal strips or plates each measuring 0.25 inch
0.002 inch (0.635 centimeter) high and each having a contact
edge radius of 0.020 inch 0.002 inch (0.5 centimeter) for at
least a 150-degree cross-sectional arc. A suggested contact mechanism
appears in figure 1 of Sec. 1500.51.
(ii) Loading device. The loading device shall be a scale or force
gauge having an accuracy of 0.5 pound (225
grams).
(3) Testing procedure. The test article shall be placed in the
contact mechanism in any reasonable position for a penetration of 0.25
to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less
than 180 degrees of the arc of the contract mechanism, and a test load
increasing to 100 pounds 0.5 pound (45.50 kilograms) shall
be evenly applied within 5 seconds. This load shall be maintained for an
additional 10 seconds.
(d) Flexure test--(1) Application. This test shall be applied to
each component of a toy containing metal wire(s), or
[[Page 466]]
other metal material(s), for stiffening or for retention of form if the
component can be bent through a 60-degree arc by a maximum force of 15
pounds 0.5 pound (6.80 kilograms) applied perpendicularly to
the major axis of the component at a point 2 inches 0.05
inch (5 centimeters) from the intersection of the component with the
main body of the toy or at the end of the component if the component is
less than 2 inches 0.05 inch (5 centimeters) long.
(2) Testing procedure. The toy shall be secured in a vise equipped
with vise shields that are fabricated from 13-gauge cold-rolled steel or
other similar material and that have a 0.375-inch (0.95-centimeter)
inside radius. The component shall then be bent through a 60-degree arc
by a force applied at a point on the component 2 inches (5 centimeters)
from the intersection of the component with the main body of the toy or
applied at the end of the component if the component is less than 2
inches (5 centimeters) long. The component shall then be bent in the
reverse direction through a 120-degree arc. This process shall be
repeated for 30 cycles at a rate of one cycle per two seconds with a 60-
second rest period occurring after each 10 cycles. Two 120-degree arc
bends shall constitute one cycle.
(e) Torque test--(1) Application--(i) General. A toy with a
projection, part, or assembly that a child can grasp with at least the
thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or
assemblies that are rigidly mounted on an accessible rod or shaft
designed to rotate along with the projections, parts, or assemblies
shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment--(i) Loading device. The loading device shall be
a torque gauge, torque wrench, or other appropriate device having an
accuracy of 0.2 inch-pound (0.23 kilogram-
centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component
firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any
reasonable test position, the clamp is fastened to the test object or
component. A torque of 4 inch-pounds 0.2 inch-pound (4.60
kilogram-centimeters) shall be applied evenly within a period of 5
seconds in a clockwise direction until a rotation of 180 degrees from
the original position has been attained or 4 inch-pounds 0.2
inch-pound (4.60 kilogram-centimeters) exceeded. The torque or maximum
rotation shall be maintained for an additional 10 seconds. The torque
shall then be removed and the test component permitted to return to a
relaxed condition. This procedure shall then be repeated in a
counterclockwise direction.
(f) Tension test--(1) Application--(i) General. Any projection of a
toy that the child can grasp with at least the thumb and forefinger or
the teeth shall be subject to this test. This test is to be conducted on
the same toy that has been subjected to the torque test described in
paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed
of pliable materials having seams (such as fabrics) shall have the seams
subjected to 15 pounds 0.5 pound (6.80 kilograms) of force
applied in any direction.
(2) Test equipment--(i) Clamps. One clamp capable of applying a
tension load to the test component is required. A second clamp suitable
for applying a tension load perpendicularly to the major axis of the
test component is also required.
(ii) Loading device. The loading device is to be a self-indicating
gauge or other appropriate means having an accuracy of 0.5
pound (225 grams).
(3) Testing procedure. With the test sample fastened in a convenient
position, and appropriate clamp shall be attached to the test object or
component. A 15-pound 0.5 pound (6.80-kilogram) direct force
shall be evenly applied, within a period of 5 seconds, parallel to the
major axis of the test component and maintained for an additional 10
seconds. The tension clamp shall then be removed and a second clamp
appropriate for pulling at 90 degrees shall be attached to the test
object or component. A 15-pound 0.5 pound (6.80-kilogram)
tensile force shall be evenly applied, within a period of 5 seconds,
perpendicularly to the major axis of the
[[Page 467]]
test component and maintained for an additional 10 seconds.
(g) Compression test--(1) Application. Any area on the surface of a
toy that is accessible to a child and inaccessible to flat-surface
contact during the impact test shall be subject to this test.
(2) Test apparatus. The loading device shall be a rigid metal disc
1.125 inches 0.015 inch (2.86 centimeters) in diameter and
0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc
shall be rounded to a radius of \1/32\ inch (0.08 centimeter) to
eliminate irregular edges. The disc shall be attached to an appropriate
compression scale having an accuracy of 0.5 pound
(225 grams).
(3) Testing procedure. The disc shall be positioned so that the
contact surface is parallel to the surface under test. A direct force of
30 pounds 0.5 pound (13.6 kilograms) shall be evenly applied
within 5 seconds through the disc. This load shall be maintained for an
additional 10 seconds. During the test the toy is to rest on a flat,
hard surface in any convenient position.
[40 FR 1486, Jan. 7, 1975; 40 FR 16192, Apr. 10, 1975, as amended at 56
FR 10, Jan. 2, 1991]
Sec. 1500.81 Exemptions for food, drugs, cosmetics, and fuels.
(a) Food, drugs, and cosmetics. Substances subject to the Federal
Food, Drug, and Cosmetic Act are exempted by section 2(f)(2) of the act;
but where a food, drug, or cosmetic offers a substantial risk of injury
or illness from any handling or use that is customary or usual it may be
regarded as misbranded under the Federal Food, Drug, and Cosmetic Act
because its label fails to reveal material facts with respect to
consequences that may result from use of the article (21 U.S.C. 321(n))
when its label fails to bear information to alert the householder to
this hazard.
(b) Fuels. A substance intended to be used as a fuel is exempt from
the requirements of the act when in containers that are intended to be
or are installed as part of the heating, cooling, or refrigeration
system of a house. A portable container used for delivery or temporary
or additional storage, and containing a substance that is a hazardous
substance as defined in section 2(f) of the act, is not exempt from the
labeling prescribed in section 2(p) of the act, even though it contains
a fuel to be used in the heating, cooking, or refrigeration system of a
house.
Sec. 1500.82 Exemption from full labeling and other requirements.
(a) Any person who believes a particular hazardous substance
intended or packaged in a form suitable for use in the household or by
children should be exempted from full label compliance otherwise
applicable under the act, because of the size of the package or because
of the minor hazard presented by the substance, or for other good and
sufficient reason, may submit to the Commission a request for exemption
under section 3(c) of the act, presenting facts in support of the view
that full compliance is impracticable or is not necessary for the
protection of the public health. The Commission shall determine on the
basis of the facts submitted and all other available information whether
the requested exemption is consistent with adequate protection of the
public health and safety. If the Commission so finds, it shall detail
the exemption granted and the reasons therefor by an appropriate order
published in the Federal Register.
(b) The Commission may on its own initiative determine on the basis
of facts available to it that a particular hazardous substance intended
or packaged in a form suitable for use in the household or by children
should be exempted from full labeling compliance otherwise applicable
under the act because of the size of the package or because of the minor
hazard presented by the substance or for other good and sufficient
reason. If the Commission so finds, it shall detail the exemption
granted and the reasons therefor by an appropriate order in the Federal
Register.
(c) Any person who believes a particular article should be exempted
from being classified as a ``banned hazardous substance'' as defined by
section 2(q)(1)(A) of the act (repeated in Sec. 1500.3(b)(15)(i)(A)),
because its functional purpose requires inclusion of a hazardous
substance, it bears labeling giving adequate directions and warnings for
safe use, and it is intended for use by children who have attained
sufficient maturity, and may reasonably
[[Page 468]]
be expected, to read and heed such directions and warnings, may submit
to the Commission a request for exemption under section 2(q)(1)(B)(i) of
the act (repeated in proviso (1) under Sec. 1500.3(b)(15(i)), presenting
facts in support of his contention. The commission shall determine on
the basis of the facts submitted, and all other available information,
whether the requested exemption is consistent with the purposes of the
act. If the Commission so finds, it shall detail the exemption granted
and the reasons therefor by an appropriate order in the Federal
Register.
(d) On its own initiative, the Commission may determine on the basis
of available facts that a particular banned hazardous substance should
be exempted from section 2(q)(1)(A) of the act (repeated in
Sec. 1500.3(b)(15)(i)(A)), because its functional purpose requires
inclusion of a hazardous substance, it bears labeling giving adequate
directions and warnings for safe use, and it is intended for use by
children who have obtained sufficient maturity, and may reasonably be
expected, to read and heed such directions and warnings. If the
Commission so finds, it shall detail the exemption granted and the
reasons therefor by an appropriate order in the Federal Register.
Sec. 1500.83 Exemptions for small packages, minor hazards, and special circumstances.
(a) The following exemptions are granted for the labeling of
hazardous substances under the provisions of Sec. 1500.82:
(1) When the sole hazard from a substance in a self-pressurized
container is that it generates pressure or when the sole hazard from a
substance is that it is flammable or extremely flammable, the name of
the component which contributes the hazards need not be stated.
(2) Common matches, including book matches, wooden matches, and so-
called ``safety'' matches are exempt from the labeling requirements of
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar
as they apply to the product being considered hazardous because of being
``flammable'' or ``extremely flammable'' as defined in
Sec. 1500.3(c)(6)(iii) and (iv).
(3) Paper items such as newspapers, wrapping papers, toilet and
cleansing tissues, and paper writing supplies are exempt from the
labeling requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)) insofar as they apply to the products being
considered hazardous because of being ``flammable'' or ``extremely
flammable'' as defined in Sec. 1500.3(c)(6)(iii) and (iv).
(4) Thread, string, twine, rope, cord, and similar materials are
exempt from the labeling requirements of section 2(p)(1) of the act
(repeated in Sec. 1500.3(b)(14)(i)) insofar as they apply to the
products being considered hazardous because of being ``flammable'' or
``extremely flammable'' as defined in Sec. 1500.3(c)(6) (iii) and (iv).
(5) Laboratory chemicals intended only for research or
investigational and other laboratory uses (except those in home
chemistry sets) are exempt from the requirements of placement provided
in Sec. 1500.121 if all information required by that section and the act
appears with the required prominence on the label panel adjacent to the
main panel.
(6) [Reserved]
(7) Rigid or semirigid ballpoint ink cartridges are exempt from the
labeling requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)), insofar as such requirements would be necessary
because the ink contained therein is a ``toxic'' substance as defined in
Sec. 1500.3(c)(2)(i), if:
(i) The ballpoint ink cartridge is of such construction that the ink
will, under any reasonably foreseeable conditions of manipulation or
use, emerge only from the ballpoint end;
(ii) When tested by the method described in Sec. 1500.3(c)(2)(i),
the ink does not have an LD-50 single oral dose of less than 500
milligrams per kilogram of body weight of the test animal; and
(iii) The cartridge does not have a capacity of more than 2 grams of
ink.
(8) Containers of paste shoe waxes, paste auto waxes, and paste
furniture and floor waxes containing toluene (also known as toluol),
xylene (also known as xylol), petroleum distillates, and/or turpentine
in the concentrations described in Sec. 1500.14(a)(3) and (5) are exempt
from the labeling requirements of Sec. 1500.14(b)(3)(ii) and (5) if the
[[Page 469]]
visicosity of such products is sufficiently high so that they will not
flow from their opened containers when inverted for 5 minutes at a
temperature of 80 deg.F., and are exempt from bearing a flammability
warning statement if the flammability of such waxes is due solely to the
presence of solvents that have flashpoints above 80 deg.F. when tested
by the method described in Sec. 1500.43.
(9) Porous-tip ink-marking devices are exempt from the labeling
requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)) and from the labeling requirements of
Sec. 1500.14(b)(1), (2), and (3)(ii) and (iii) insofar as such
requirements would be necessary because the ink contained therein is a
toxic substance as defined in Sec. 1500.3(c)(2)(i), and/or because the
ink contains 10 percent or more by weight of toluene (also known as
toluol), xylene (also known as xylol), or petroleum distillates as
defined in Sec. 1500.14(a)(3), and/or because the ink contains 10
percent or more by weight of ethylene glycol; provided that:
(i) The porous-tip ink-marking devices are of such construction
that:
(A) The ink is held within the device by an absorbent material so
that no free liquid is within the device; and
(B) Under any reasonably foreseeable conditions of manipulation and
use, including reasonably foreseeable abuse by children, the ink will
emerge only through the porous writing nib of the device; and
(ii)(A) The device has a capacity of not more than 10 grams of ink
and the ink, when tested by methods described in Sec. 1500.3(c)(2)(i),
has an LD-50 single oral dose of not less than 2.5 grams per kilogram of
body weight of the test animal; or
(B) The device has a capacity of not more than 12 grams of ink and
the ink, when tested by methods described in Sec. 1500.3(c)(2)(i), has
an LD-50 single oral dose of not less than 3.0 grams per kilogram of
body weight of the test animal.
(10) Viscous nitrocellulose-base adhesives containing more than 4
percent methyl alcohol by weight are exempt from the label statement
``Cannot be be made nonpoisonous'' required by Sec. 1500.14(b)(4) if:
(i) The total amount of methyl alcohol by weight in the product does
not exceed 15 percent; and
(ii) The contents of any container does not exceed 2 fluid ounces.
(11) Packages containing polishing or cleaning products which
consist of a carrier of solid particulate or fibrous composition and
which contain toluene (also known as toluol), xylene (also known as
xylol), or petroleum distillates in the concentrations described in
Sec. 1500.14(a) (1) and (2) are exempt from the labeling requirements of
Sec. 1500.14(b)(3)(ii) if such toluene, xylene, or petroleum distillate
is fully absorbed by the solid, semisolid, or fibrous carrier and cannot
be expressed therefrom with any reasonably foreseeable conditions of
manipulation.
(12) Containers of dry ink intended to be used as a liquid ink after
the addition of water are exempt from the labeling requirements of
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) and from
the labeling requirements of Sec. 1500.14(b) (1) and (2) insofar as such
requirements would be necessary because the dried ink contained therein
is a toxic substance as defined in Sec. 1500.3(c)(2)(i) and/or because
the ink contains 10 percent or more of ethylene glycol as defined in
Sec. 1500.14(a)(2); provided that:
(i) When tested by the method described in Sec. 1500.3(c)(2)(i), the
dry ink concentrate does not have an LD-50 (lethal dose, median; lethal
for 50 percent or more of test group) single oral dose of less than 1
gram per kilogram of body weight of the test animal.
(ii) The dry ink concentrate enclosed in a single container does not
weigh more than 75 milligrams.
(iii) The dry ink concentrate does not contain over 15 percent by
weight of ethylene glycol.
(13) Containers of liquid and semisolid substances such as viscous-
type paints, varnishes, lacquers, roof coatings, rubber vulcanizing
preparations, floor covering adhesives, glazing compounds, and other
viscous products containing toluene (also known as toluol), xylene (also
known as xylol), or petroleum distillates in concentrations described in
Sec. 1500.14(a)(3) are exempt from the labeling requirements of
[[Page 470]]
Sec. 1500.14(b)(3)(ii) insofar as that subdivision applies to such
toluene, xylene, or petroleum distillates, provided that the viscosity
of the substance or of any liquid that may separate or be present in the
container is not less than 100 Saybolt universal seconds at 100 deg.F.
(14) Customer-owned portable containers that are filled by retail
vendors with gasoline, kerosene (kerosine), or other petroleum
distillates are exempt from the provision of section 2(p)(1)(A) of the
act (which requires that the name and place of business of the
manufacturer, distributor, packer, or seller appear on the label of such
containers) provided that all the other label statements required by
section 2(p)(1) of the act and Sec. 1500.14(b)(3) appear on the labels
of containers of the substances named in this subparagraph.
(15) Cellulose sponges are exempt from the labeling requirements of
section 2(p)(1) of the act and Sec. 1500.14(b)(1) insofar as such
requirements would be necessary because they contain 10 percent or more
of diethylene glycol as defined in Sec. 1500.14(a)(1), provided that:
(i) The cellulose sponge does not contain over 15 percent by weight
of diethylene glycol; and
(ii) The diethylene glycol content is completely held by the
absorbent cellulose material so that no free liquid is within the sponge
as marketed.
(16) Containers of substances which include salt (sodium chloride)
as a component are exempt from the labeling requirements of section
2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such
requirements would be necessary because the salt contained therein is
present in a quantity sufficient to render the article ``toxic'' as
defined in Sec. 1500.3(3)(2)(i), provided that the labels of such
containers bear a conspicuous statement that the product contains salt.
(17) The labeling of substances containing 10 percent or more of
ferrous oxalate is exempt from the requirement of Sec. 1500.129(f) that
it bear the word ``poison'' which would be required for such
concentration of a salt of oxalic acid.
(18) Packages containing articles intended as single-use spot
removers, and which consist of a cotton pad or other absorbent material
saturated with a mixture of drycleaning solvents, are exempt from the
labeling requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)) insofar as they apply to the ``flammable'' hazard
as defined in Sec. 1500.3(c)(6)(iv), provided that:
(i) The article is packaged in a sealed foil envelope;
(ii) The total amount of solvent in each package does not exceed 4.5
milliliters; and
(iii) The article will ignite only when in contact with an open
flame, and when so ignited, the article burns with a sooty flame.
(19) Packages containing articles intended as single-use spot
removers, and which consist of a cotton pad or other absorbent material
containing methyl alcohol, are exempt from the labeling requirements of
Sec. 1500.14(b)(4), if:
(i) The total amount of cleaning solvent in each package does not
exceed 4.5 milliliters of which not more than 25 percent is methyl
alcohol; and
(ii) The liquid is completely held by the absorbent materials so
that no free liquid is within the packages marketed.
(20) Cigarette lighters containing petroleum distillate fuel are
exempt from the labeling requirements of section 2(p)(1) of the act
(repeated in Sec. 1500.3(b)(14)(i)) and Sec. 1500.14(b)(3) insofar as
such requirements would be necessary because the petroleum distillate
contained therein is flammable and because the substance is named in
Sec. 1500.14(a)(3) as requiring special labeling, provided that:
(i) Such lighters contain not more than 10 cubic centimeters of fuel
at the time of sale; and
(ii) Such fuel is contained in a sealed compartment that cannot be
opened without the deliberate removal of the flush-set, screw-type
refill plug of the lighter.
(21) Containers of dry granular fertilizers and dry granular plant
foods are exempt from the labeling requirements of section 2(p)(1) of
the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such requirements
would be necessary because the fertilizer or plant food contained
therein is a toxic substance as defined in Sec. 1500.3(c)(2)(i),
provided that:
(i) When tested by the method described in Sec. 1500.3(c)(2)(i), the
product
[[Page 471]]
has a single dose LD-50 of not less than 3.0 grams per kilogram of body
weight of the test animal;
(ii) The label of any such exempt dry granular fertilizers discloses
the identity of each of the hazardous ingredients;
(iii) The label bears the name and address of the manufacturer,
packer, distributor, or seller; and
(iv) The label bears the statement ``Keep out of the reach of
children'' or its practical equivalent.
(22) Small plastic capsules containing a paste composed of powdered
metal solder mixed with a liquid flux are exempt from the requirements
of section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)), if:
(i) The capsule holds not more than one-half milliliter of the
solder mixture;
(ii) The capsule is sold only as a component of a kit; and
(iii) Adequate caution statements appear on the carton of the kit
and on any accompanying labeling which bears directions for use.
(23) Chemistry sets and other science education sets intended
primarily for use by juveniles, and replacement containers of chemicals
for such sets, are exempt from the requirements of section 2(p)(1) of
the act (repeated in Sec. 1500.3(b)(14)(i)), if:
(i) The immediate container of each chemical that is hazardous as
defined in the act and regulations thereunder bears on its main panel
the name of such chemical, the appropriate signal word for that
chemical, and the additional statement ``Read back panel before using''
(or ``Read side panel before using,'' if appropriate) and bears on the
back (or side) panel of the immediate container the remainder of the
appropriate cautionary statement for the specific chemical in the
container;
(ii) The experiment manual or other instruction book or booklet
accompanying such set bears on the front page thereof, as a preface to
any written matter in it (or on the cover, if any there be), the
following caution statement within the borders of a rectangle and in the
type size specified in Sec. 1500.121:
------------------------------------------------------------------
WARNING--This set contains chemicals that may be harmful
if misused. Read cautions on individual containers
carefully. Not to be used by children except under adult
supervision
------------------------------------------------------------------
; and
(iii) The outer carton of such set bears on the main display panel
within the borders of a rectangle, and in the type size specified in
Sec. 1500.121, the caution statement specified in paragraph (a)(23)(ii)
of this section.
(24) Fire extinguishers containing fire extinguishing agents which
are stored under pressure or which develop pressure under normal
conditions of use are exempt from the labeling requirements of section
2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar as such
requirements apply to the pressure hazard as defined in
Sec. 1500.3(c)(7)(i), provided that:
(i) If the container is under pressure both during storage and under
conditions of use, it shall be designed to withstand a pressure of at
least 6 times the charging pressure at 70 deg.F., except that carbon
dioxide extinguishers shall be constructed and tested in accordance with
applicable Interstate Commerce Commission specifications; or
(ii) If the container is under pressure only during conditions of
use, it shall be designed to withstand a pressure of not less than 5
times the maximum pressure developed under closed nozzle conditions at
70 deg.F. or 1\1/2\ times the maximum pressure developed under closed
nozzle conditions at 120 deg.F., whichever is greater.
(25) Cleaning and spot removing kits intended for use in cleaning
carpets, furniture, and other household objects; kits intended for use
in coating, painting, antiquing, and similarly processing furniture,
furnishings, equipment, sidings, and various other surfaces; and kits
intended for use in photographic color processing are exempt from the
requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)) and from the requirements of Sec. 1500.14,
provided that:
(i) The immediate container of each hazardous substance in the kit
is fully labeled and in conformance with the requirements of the act and
regulations thereunder; and
[[Page 472]]
(ii) The carton of the kit bears on the main display panel (or
panels) within a borderline, and in the type size specified in
Sec. 1500.121, the caution statement ``(Insert proper signal word as
specified in paragraph (a)(25)(iii) of this section). This kit contains
the following chemicals that may be harmful if misused: (List hazardous
chemical components by name.) Read cautions on individual containers
carefully. Keep out of the reach of children.''
(iii) If either the word ``POISON'' or ``DANGER'' is required on the
container of any component of the kit, the same word shall be required
to appear as part of the caution statement on the kit carton. If both
``POISON'' and ``DANGER'' are required in the labeling of any component
or components in the kit, the word ``POISON'' shall be used. In all
other cases the word ``WARNING'' or ``CAUTION'' shall be used.
(26) Packages containing articles intended as single-use spot
removers and containing methyl alcohol are exempt from the labeling
specified in Sec. 1500.14(b)(4), if:
(i) The total amount of cleaning solvent in each unit does not
exceed 1 milliliter, of which not more than 40 percent is methyl
alcohol;
(ii) The liquid is contained in a sealed glass ampoule enclosed in a
plastic container with a firmly attached absorbent wick at one end
through which the liquid from the crushed ampoule must pass, under the
contemplated conditions of use; and
(iii) The labeling of each package of the cleaner bears the
statement ``WARNING--Keep out of the reach of children,'' or its
practical equivalent, and the name and place of business of the
manufacturer, packer, distributor, or seller.
(27) Packaged fireworks assortments intended for retail distribution
are exempt from section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)), if:
(i) The package contains only fireworks devices suitable for use by
the public and designed primarily to produce visible effects by
combustion, except that small devices designed to produce audible
effects may also be included if the audible effect is produced by a
charge of not more than 2 grains of pyrotechnic composition;
(ii) Each individual article in the assortment is fully labeled and
in conformance with the requirements of the act and regulations
thereunder; and
(iii) The outer package bears on the main display panel (or panels),
within the borders of a rectangle and in the type size specified in
Sec. 1500.121, the caution statement ``WARNING--This assortment contains
items that may be hazardous if misused and should be used only under
adult supervision. IMPORTANT--Read cautions on individual items
carefully.'' (See also Sec. 1500.14(b)(7); Sec. 1500.17(a) (3), (8) and
(9); Sec. 1500.85(a)(2); and part 1507).
(28) Packages containing felt pads impregnated with ethylene glycol
are exempt from the labeling requirements of Sec. 1500.14(b)(1), if:
(i) The total amount of ethylene glycol in each pad does not exceed
1 gram; and
(ii) The liquid is held by the felt pad so that no free ethylene
glycol is within the package.
(29) Cigarette lighters containing butane and/or isobutane fuel are
exempt from the labeling requirements of section 2(p)(1) of the act
(repeated in Sec. 1500.3(b)(14)(i)) insofar as such requirements would
otherwise be necessary because the fuel therein is extremely flammable
and under pressure, provided that:
(i) The lighters contain not more than 12 grams of fuel at the time
of sale; and
(ii) The fuel reservoir is designed to withstand a pressure of at
least 1\1/2\ times the maximum pressure which will be developed in the
container at 120 deg.F.
(30) The outer retail containers of solder kits each consisting of a
small tube of flux partially surrounded by a winding of wire-type
cadmium-free silver solder are exempt from the labeling requirements of
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)), if:
(i) The metal solder contains no cadmium and is not otherwise
hazardous under the provisions of the act;
(ii) The tube of flux in the kit is fully labeled and in conformance
with the act and regulations thereunder, and any accompanying literature
that
[[Page 473]]
bears directions for use also bears all the information required by
section 2(p) of the act; and
(iii) The main panel of the outer container bears in type size
specified in Sec. 1500.121 the following: (A) The signal word; (B) a
statement of principal hazard or hazards; (C) the statement ``Keep out
of the reach of children,'' or its practical equivalent; and (D)
instructions to read other cautionary instructions on the tube of flux
within.
(31) Visual novelty devices consisting of sealed units, each of
which unit is a steel and glass cell containing perchloroethylene (among
other things), are exempt from the requirements of Sec. 1500.121(a) that
would otherwise require a portion of the warning statement to appear on
the glass face of the device, provided that:
(i) The device contains not more than 105 milliliters of
perchloroethylene and contains no other component that contributes
substantially to the hazard; and
(ii) The following cautionary statement appears on the device (other
than on the bottom) in the type size specified in Sec. 1500.121 (c) and
(d):
Caution--If Broken, Resultant Vapors May Be Harmful
Contains perchloroethylene. Do not expose to extreme heat. If broken
indoors, open windows and doors until all odor of chemical is gone.
Keep out of the reach of children.
A practical equivalent may be substituted for the statement ``Keep out
of the reach of children.''
(32) Hollow plastic toys containing mineral oil are exempt from the
labeling specified in Sec. 1500.14(b)(3)(ii), if:
(i) The article contains no other ingredient that would cause it to
possess the aspiration hazard specified in Sec. 1500.14(b)(3)(ii);
(ii) The article contains not more than 6 fluid ounces of mineral
oil;
(iii) The mineral oil has a viscosity of at least 70 Saybolt
universal seconds at 100 deg.F.;
(iv) The mineral oil meets the specifications in the N.F. for light
liquid petrolatum; and
(v) The container bears the statement ``CAUTION--Contains light
liquid petrolatum N.F. Discard if broken or leak develops.''
(33) Containers of mineral oil having a capacity of not more than 1
fluid ounce and intended for use in producing a smoke effect for toy
trains are exempt from the labeling specified in Sec. 1500.14(b)(3), if:
(i) The mineral oil meets the specifications in the N.F. for light
liquid petrolatum;
(ii) The mineral oil has a viscosity of at least 130 Saybolt
universal seconds at 100 deg.F.;
(iii) The article contains no other ingredient that contributes to
the hazard; and
(iv) The label declares the presence light liquid petrolatum and the
name and place of business of the manufacturer, packer, distributor, or
seller.
(34) Viscous products containing more than 4 percent by weight of
methyl alcohol, such as adhesives, asphalt-base roof and tank coatings,
and similar products, are exempt from bearing the special labeling
required by Sec. 1500.14(b)(4), if:
(i) The product contains not more than 15 percent by weight of
methyl alcohol;
(ii) The methyl alcohol does not separate from the other ingredients
upon standing or through any foreseeable use or manipulation;
(iii) The viscosity of the product is not less than 7,000
centipoises at 77 deg.F., unless the product is packaged in a
pressurized container and is dispensed as a liquid unsuitable for
drinking; and
(iv) The labeling bears the statement ``Contains methyl alcohol. Use
only in well-ventilated area. Keep out of the reach of children.''
(35) Individual blasting caps are exempt from bearing the statement
``Keep out of the reach of children,'' or its practical equivalent, if:
(i) Each cap bears conspicuously in the largest type size
practicable the statement ``DANGEROUS--BLASTING CAPS--EXPLOSIVE''; and
(ii) The outer carton and any accompanying printed matter bear
appropriate, complete cautionary labeling.
(36) Individual toy rocket propellant devices and separate delay
train and/or recovery system activation devices intended for use with
premanufactured model rocket engines are exempt from bearing the full
labeling required by
[[Page 474]]
section 2(p)(1) of the act (repeated in Sec. 1500.3(b)(14)(i)) insofar
as such requirements would be necessary because the articles are
flammable or generate pressure, provided that:
(i) The devices are designed and constructed in accordance with the
specifications in Sec. 1500.85(a) (8) or (9):
(ii) Each individual device or retail package of devices bears the
following:
(A) The statement ``WARNING--FLAMMABLE: Read instructions before
use'';
(B) The common or usual name of the article;
(C) A statement of the type of engine and use classification;
(D) Instructions for safe disposal; and
(E) Name and place of business of manufacturer or distributor; and
(iii) Each individual rocket engine or retail package of rocket
engines distributed to users is accompanied by an instruction sheet
bearing complete cautionary labeling and instructions for safe use and
handling of the individual rocket engines.
(37) Glues with a cyanoacrylate base in packages containing 3 grams
or less are exempt from the requirement of Sec. 1500.121(d) that
labeling which is permitted to appear elsewhere than on the main label
panel must be in type size no smaller than 6 point type, provided that:
(i) The main panel of the immediate container bears both the proper
signal word and a statement of the principal hazard or hazards
associated with this product, as provided by Sec. 1500.121 (a) and (c);
(ii) The main panel of the immediate container also bears an
instruction to read carefully additional warnings elsewhere on the label
and on any outer package, accompanying leaflet, and display card. The
instruction to read additional warnings must comply with the size,
placement, conspicuousness, and contrast requirements of Sec. 1500.121;
and
(iii) The remainder of the cautionary labeling required by the act
that is not on the main label panel must appear elsewhere on the label
in legible type and must appear on any outer package, accompanying
leaflet, and display card. If there is no outer package, accompanying
leaflet, or display card, then the remainder of the required cautionary
labeling must be displayed on a tag or other suitable material that is
securely affixed to the article so that the labeling will remain
attached throughout the conditions of merchandising and distribution to
the ultimate consumer. That labeling which must appear on any outer
package, accompanying leaflet, tag, or other suitable material must
comply with the size, placement, contrast, and conspicuousness
requirements of Sec. 1500.121(d).
(38) Rigid or semi-rigid writing instruments and ink cartridges
having a writing point and an ink reservoir are exempt from the labeling
requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i) of the regulations) and of regulations issued
under section 3(b) of the act (Sec. 1500.14(b)(1, 2)) insofar as such
requirements would be necessary because the ink contained therein is a
``toxic'' substance as defined in Sec. 1500.3(c)(2)(i) and/or because
the ink contains 10 percent or more by weight ethylene glycol or
diethylene glycol, if all the following conditions are met:
(i) The writing instrument or cartridge is of such construction that
the ink will, under any reasonably foreseeable condition of manipulation
and use, emerge only from the writing tip.
(ii) When tested by the method described in Sec. 1500.3(c)(2)(i),
the ink does not have an LD-50 single oral dose of less than 2.5 grams
per kilogram of body weight of the test animal.
(iii) If the ink contains ethylene glycol or diethylene glycol, the
amount of such substance, either singly or in combination, does not
exceed 1 gram per writing instrument or cartridge.
(iv) The amount of ink in the writing instrument or cartridge does
not exceed 3 grams.
[38 FR 27012, Sept. 27, 1973; 42 FR 33026, June 29, 1977, as amended at
43 FR 32745, July 28, 1978; 43 FR 47176, Oct. 13, 1978; 44 FR 42678,
July 20, 1979; 46 FR 11513, Feb. 9, 1981; 48 FR 16, Jan. 3, 1983]
Sec. 1500.85 Exemptions from classification as banned hazardous substances.
(a) The term banned hazardous substances as used in section
2(q)(1)(A) of the act shall not apply to the following articles provided
that these articles
[[Page 475]]
bear labeling giving adequate directions and warnings for safe use:
(1) Chemistry sets and other science education sets intended
primarily for juveniles, and replacement components for such sets, when
labeled in accordance with Sec. 1500.83(a)(23).
(2) Firecrackers designed to produce audible effects, if the audible
effect is produced by a charge of not more than 50 milligrams (.772
grains) of pyrotechnic composition. (See also Sec. 1500.14(b)(7);
Sec. 1500.17(a) (3), (8) and (9); and part 1507).
(3) [Reserved]
(4) Educational materials such as art materials, preserved
biological specimens, laboratory chemicals, and other articles intended
and used for educational purposes.
(5) Liquid fuels containing more than 4 percent by weight of methyl
alcohol that are intended and used for operation of miniature engines
for model airplanes, boats, cars, etc.
(6) Novelties consisting of a mixture of polyvinyl acetate, U.S.
Certified Colors, and not more than 25 percent by weight of acetone, and
intended for blowing plastic balloons.
(7) Games containing, as the sole hazardous component, a self-
pressurized container of soap solution or similar foam-generating
mixture provided that the foam-generating component has no hazards other
than being in a self-pressurized container.
(8) Model rocket propellant devices designed for use in light-
weight, recoverable, and reflyable model rockets, provided such devices:
(i) Are designed to be ignited by electrical means.
(ii) Contain no more than 62.5 grams (2.2 ounces) of propellant
material and produce less than 80 newton-seconds (17.92 pound seconds)
of total impulse with thrust duration not less than 0.050 second.
(iii) Are constructed such that all the chemical ingredients are
preloaded into a cylindrical paper or similarly constructed nonmetallic
tube that will not fragment into sharp, hard pieces.
(iv) Are designed so that they will not burst under normal
conditions of use, are incapable of spontaneous ignition, and do not
contain any type of explosive or pyrotechnic warhead other than a small
parachute or recovery-system activation charge.
(9) Separate delay train and/or recovery system activation devices
intended for use with premanufactured model rocket engines wherein all
of the chemical ingredients are preloaded so the user does not handle
any chemical ingredient and are so designed that the main casing or
container does not rupture during operation.
(10) Solid fuel pellets intended for use in miniature jet engines
for propelling model jet airplanes, speed boats, racing cars, and
similar models, provided such solid fuel pellets:
(i) Weigh not more than 11.5 grams each.
(ii) Are coated with a protective resinous film.
(iii) Contain not more than 35 percent potassium dichromate.
(iv) Produce a maximum thrust of not more than 7\1/2\ ounces when
used as directed.
(v) Burn not longer than 12 seconds each when used as directed.
(11) Fuses intended for igniting fuel pellets exempt under
subparagraph (10) of this paragraph.
(12) Kits intended for construction of model rockets and jet
propelled model airplanes requiring the use of difluorodichloromethane
as a propellant, provided the outer carton bears on the main panel in
conspicuous type size the statement ``WARNING--Carefully read
instructions and cautions before use.''
(13) Flammable wire materials intended for electro-mechanical
actuation and release devices for model kits described in paragraph (12)
of this section, provided each wire does not exceed 15 milligrams in
weight.
(b) [Reserved]
[38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22935, June 8, 1976;
42 FR 43391, Aug. 29, 1977; 48 FR 16, Jan. 3, 1983]
Sec. 1500.86 Exemptions from classification as a banned toy or other banned article for use by children.
(a) The term banned hazardous substance as used in section
2(q)(1)(A) of the act (repeated in Sec. 1500.3(b)(15)(i)(A)) of the act
shall not apply to the following articles:
[[Page 476]]
(1) Toy rattles described in Sec. 1500.18(a)(1) in which the rigid
wires, sharp protrusions, or loose small objects are internal and
provided that such rattles are constructed so that they will not break
or deform to expose or release the contents either in normal use or when
subjected to reasonably foreseeable damage or abuse.
(2) Dolls and stuffed animals and other similar toys described in
Sec. 1500.18(a)(3) in which the components that have the potential for
causing laceration, puncture wound injury, or other similar injury are
internal, provided such dolls, stuffed animals, and other similar toys
are constructed so that they will not break or deform to expose such
components either in normal use or when subjected to reasonably
foreseeable damage or abuse.
(3) [Reserved]
(4) Any article known as a ``baby-bouncer,'' ``walker-jumper,'' or
``baby-walker'' and any other similar article (referred to in this
paragraph as ``article(s)'') described in Sec. 1500.18(a)(6) provided:
(i) The frames are designed and constructed in a manner to prevent
injury from any scissoring, shearing, or pinching when the members of
the frame or other components rotate about a common axis or fastening
point or otherwise move relative to one another; and
(ii) Any coil springs which expand when the article is subjected to
a force that will extend the spring to its maximum distance so that a
space between successive coils is greater than one-eighth inch (0.125
inch) are covered or otherwise designed to prevent injuries; and
(iii) All holes larger than one-eighth inch (0.125 inch) in diameter
and slots, cracks, or hinged components in any portion of the article
through which a child could insert, in whole or in part a finger, toe,
or any other part of the anatomy are guarded or otherwise designed to
prevent injuries; and
(iv) The articles are designed and constructed to prevent accidental
collapse while in use; and
(v) The articles are designed and constructed in a manner that
eliminates from any portion of the article the possibility of presenting
a mechanical hazard through pinching, bruising, lacerating, crushing,
breaking, amputating, or otherwise injuring portions of the human body
when in normal use or when subjected to reasonably foreseeable damage or
abuse; and
(vi) Any article which is introduced into interstate commerce after
the effective date of this subparagraph is labeled:
(A) With a conspicuous statement of the name and address of the
manufacturer, packer, distributor, or seller; and
(B) With a code mark on the article itself and on the package
containing the article or on the shipping container, in addition to the
invoice(s) or shipping document(s), which code mark will permit future
identification by the manufacturer of any given model (the manufacturer
shall change the model number whenever the article undergoes a
significant structural or design modification); and
(vii) The manufacturer or importer of the article shall make, keep,
and maintain for 3 years records of sale, distribution, and results of
inspections and tests conducted in accordance with this subparagraph and
shall make such records available at all reasonable hours upon request
by any officer or employee of the Consumer Product Safety Commission and
shall permit such officer or employee to inspect and copy such records,
to make such stock inventories as he deems necessary, and to otherwise
check the correctness of such records.
(5) Clacker balls described in Sec. 1500.18(a)(7) that have been
designed, manufactured, assembled, labeled, and tested in accordance
with the following requirements, and when tested at the point of
production or while in interstate commerce or while held for sale after
shipment in interstate commerce do not exceed the failure rate
requirements of the table in paragraph (a)(5)(vi) of this section:
(i) The toy shall be so designed and fabricated that:
(A) Each ball: Weighs less than 50 grams; will not shatter, crack,
or chip; is free of cracks, flash (ridges due to imperfect molding), and
crazing (tiny surface cracks); and is free of rough or sharp edges
around any hole where the cord enters or over any surface with
[[Page 477]]
which the cord may make contact. Each ball is free of internal voids
(holes, cavities, or air bubbles) if the balls are made of materials
other than those materials (such as ABS (acrylonitrile butadiene
styrene), nylon, and high-impact polystyrene) that are injection-molded
and possess high-impact characteristics.
(B) The cord: Is of high tensile strength, synthetic fibers that are
braided or woven, having a breaking strength in excess of 445 Newtons
(100 pounds); is free of fraying or any other defect that might tend to
reduce its strength in use; is not molded in balls made of casting
resins which tend to wick up or run up on the outside of the cord; and
is affixed to a ball at the center of the horizontal plane of the ball
when it is suspended by the cord. Clacker balls where the mass of each
ball is less than 12 grams (0.42 oz.) and the distance between the
center of the pivot and the center of the ball cannot exceed 180 mm (7.1
inches) may have a minimum cord breaking strength of less than 445
Newtons (100 pounds), as computed by the following formula:
Adjusted Cord Breaking Strength in Newtons=0.1382(mb)
(Rp), where mb=mass of a single ball in grams and
Rp=pivot length in mm.
(C) When the cord is attached to the ball by means of a knot, the
end beneath the knot is chemically fused or otherwise treated to prevent
the knot from slipping out or untying in use.
(ii) The toy shall be tested at the time of production:
(A) By using the sampling procedure described in the table in
subdivision (vi) of this subparagraph to determine the number of units
to be tested.
(B) By subjecting each ball tested to 10 drops of a 2.25 kg (5-
pound) steel impact rod or weight (57-mm (2\1/4\-inch) diameter with a
flat head) dropped 1220 mm (48 inches) in a vented steel or aluminum
tube (60-mm (2\3/8\-inch) inside diameter) when the ball is placed on a
steel or cast iron mount. Clacker balls where the mass of each ball is
less than 12 grams (0.42 oz.) and the distance between the center of the
pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may
be tested by dropping the impact weight from a height of less than 1220
mm (48 in.), where the height is computed as follows:
Adjusted drop height in mm=179x10-5(mb)
(Rp2), where mb=mass of a single ball in grams and
Rp=pivot length in mm.
Any ball showing any chipping, cracking, or shattering shall be counted
as a failure within the meaning of the third column of the table in
paragraph (a)(5)(vi) of this section.
(C) By inspecting each ball tested for smoothness of finish on any
surface of the ball which may come in contact with the cord during use.
A cotton swab shall be rubbed vigorously over each such surface or area
of the ball; if any cotton fibers are removed, the ball shall be counted
as a failure within the meaning of the fourth column of the table in
subdivision (vi) of this paragraph. The toy shall also be checked to
ascertain that there is no visibly perceptible ``wicking up'' or
``running up'' of the casting resins on the outside of the cord in the
vicinity where the ball is attached.
(D) By fully assembling the toy and testing the cord in such a
manner as to test both the strength of the cord and the adequacy with
which the cord is attached to the ball and any holding device such as a
tab or ring included in the assembly. The fully assembled article shall
be vertically suspended by one ball and a 445-Newton (100-pound) test
applied to the bottom ball. Clacker balls where the mass of each ball is
less than 12 grams (0.42 oz.) and the distance between the center of the
pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may
be tested with a force of under 445 Newtons (100 pounds). The test force
for these clacker balls shall be the same as the cord breaking strength
calculated in Sec. 1500.86(a)(5)(i)(B). Any breaking, fraying, or
unraveling of the cord or any sign of slipping, loosening, or
unfastening shall be counted as a failure within the meaning of the
fourth column of the table in paragraph (a)(5)(vi) of this section.
(E) By additionally subjecting any ring or other holding device to a
222-Newton (50-pound) test load applied to both cords; the holding
device is to be securely fixed horizontally in a suitable clamp in such
a manner as to support 50 percent of the area of such holding device and
the balls are suspended
[[Page 478]]
freely. Clacker balls where the mass of each ball is less than 12 grams
(0.42 oz.) and the distance between the center of the pivot and the
center of the ball cannot exceed 180 mm (7.1 inches) may have their
holding device tested with a force of less than 222 Newtons (50 pounds).
The holding device test force for these clacker balls shall be half of
the cord breaking strength calculated in Sec. 1500.86(a)(5)(i)(B). Any
breaking, cracking, or crazing of the ring or other holding device shall
be counted as a failure within the meaning of the fourth column of the
table in paragraph (a)(5)(vi) of this section.
(F) By cutting each ball tested in half and then cutting each half
perpendicularly to the first cut into three or more pieces of
approximately equal thickness. Each portion is to be inspected before
and after cutting, and any ball showing any flash, crack, crazing, or
internal voids on such inspection is to be counted as a failure within
the meaning of the fourth column of the table in paragraph (a)(5)(vi) of
this section. Balls that are injection-molded and possess high-impact
characteristics (such as injection-molded balls made of ABS, nylon, or
high-impact polystyrene) though exempt from the requirements that there
be no internal voids, must be tested to determine the presence of any
flash, crack or grazing. A transparent ball shall be subjected to the
same requirements except that it may be visually inspected without
cutting.
(iii) The toy shall be fully assembled for use at time of sale,
including the proper attachments of balls, cords, knots, loops, or other
holding devices.
(iv) The toy shall be labeled:
(A) With a conspicuous statement of the name and address of the
manufacturer, packer, distributor, or seller.
(B) To bear on the toy itself and/or the package containing the toy
and/or the shipping container, in addition to the invoice(s) and
shipping document(s), a code or mark in a form and manner that will
permit future identification of any given batch, lot, or shipment by the
manufacturer.
(C) To bear a conspicuous warning statement on the main panel of the
retail container and display carton and on any accompanying literature:
That if cracks develop in a ball or if the cord becomes frayed or loose
or unfastened, use of the toy should be discontinued; and if a ring or
loop or other holding device is present, the statement ``In use, the
ring or loop must be placed around the middle finger and the two cords
positioned over the forefinger and held securely between the thumb and
forefinger,'' or words to that effect which will provide adequate
instructions and warnings to prevent the holding device from
accidentally slipping out of the hand. Such statements shall be printed
in sharply contrasting color within a borderline and in letters at least
6 mm (\1/4\ inch) high on the main panel of the container and at least 3
mm (\1/8\) high on all accompanying literature.
(v) The manufacturer of the toy shall make, keep, and maintain for 3
years records of sale, distribution, and results of inspections and
tests conducted in accordance with this subparagraph and shall make such
records available upon request at all reasonable hours by any officer or
employee of the Consumer Product Safety Commission, and shall permit
such officer or employee to inspect and copy such records and to make
such inventories of stock as he deems necessary and otherwise to check
the correctness of such records.
(vi) The lot size, sample size, and failure rate for testing clacker
balls are as follows:
----------------------------------------------------------------------------------------------------------------
Failure rate
Number of units in batch, Failure rate constituting constituting rejection
shipment, delivery, lot, or Number of units in rejection when testing per when testing per Sec.
retail stock random sample Sec. 1500.86(a)(5)(ii)(B) 1500.86(a)(5)(ii) (C),
(D), (E), and (F)
----------------------------------------------------------------------------------------------------------------
50 or less...................... 8 1 1
51 to 90........................ 13 1 1
91 to 150....................... 20 1 1
151 to 280...................... 32 1 2
281 to 500...................... 50 1 2
501 to 1,200.................... 80 2 4
1,201 to 3,200.................. 125 2 6
3,201 to 10,000................. 200 3 10
[[Page 479]]
10,001 to 35,000................ 315 4 16
35,001 to 150,000............... 500 6 25
150,001 to 500,000.............. 800 8 40
500,001 and over................ 1,250 11 62
----------------------------------------------------------------------------------------------------------------
(vii) Applicability of the exemption provided by this paragraph
shall be determined through use of the table in paragraph (a)(5)(vi) of
this section. A random sample of the number of articles as specified in
the second column of the table shall be selected according to the number
of articles in a particular batch, shipment, delivery, lot, or retail
stock per the first column. A failure rate as shown in either the third
or fourth column shall indicate that the entire batch, shipment,
delivery, lot, or retail stock has failed and thus is not exempted under
this paragraph from classification as a banned hazardous substance.
(6) Caps (paper or plastic) described in Sec. 1500.18(a)(5),
provided:
(i) Such articles do not produce peak sound pressure levels greater
than 158 decibels when tested in accordance with Sec. 1500.47, and
provided any such articles producing peak sound pressure levels greater
than 138 decibels but not greater than 158 decibels when tested in
accordance with Sec. 1500.47 shall bear the following statement on the
carton and in the accompanying literature in accordance with
Sec. 1500.121: ``WARNING--Do not fire closer than 1 foot to the ear. Do
not use indoors.''
(ii) Any person who elects to distribute toy caps in accordance with
paragraph (a)(6)(i) of this section shall promptly notify the Consumer
Product Safety Commission, Bureau of Compliance, Washington, D.C. 20207,
of their intention and shall conduct or participate in a program to
develop caps that produce a sound pressure level of not more than 138
decibels when tested in accordance with Sec. 1500.47.
(iii) Any person who elects to distribute caps in accordance with
paragraph (a)(6)(i) of this section shall, after notification of his
intentions to the Commission in accordance with paragraph (a)(6)(ii) of
this section, submit to the Consumer Product Safety Commission, Bureau
of Compliance, Washington, DC 20207, a progress report not less
frequently than once every 3 months concerning the status of his program
to develop caps that produce a sound level of not more than 138 decibels
when tested in accordance with Sec. 1500.47.
(7) Dive sticks and similar articles described in
Sec. 1500.18(a)(18) that come to rest at the bottom of a container of
water in a position in which the long axis of the article is greater
than 45 degrees from vertical when measured in accordance with the
following test method:
(i) Test equipment.
(A) A container that is filled with tap water to a depth at least 3
inches [76 mm] greater than the longest dimension of the dive stick. The
container shall:
(1) Be sufficiently wide to allow the dive stick to lie along the
bottom with its long axis in a horizontal position,
(2) Have clear side walls to permit observation of the dive stick
under water, and
(3) Be placed on a level surface and have a flat bottom.
(B) A protractor or other suitable angle measurement device that has
an indicator for 45 degrees from vertical.
(ii) Testing procedure
(A) If the dive stick is sold such that the consumer is required to
attach an additional component(s) to the dive stick, then the product
shall be tested both with and without the attachment(s).
(B) From just above the water surface, drop the dive stick into the
container.
(C) Let the dive stick sink and come to rest at the bottom of the
container. If the dive stick is designed so that the weight can be
adjusted by adding water or other substance, adjust the weight so that
the dive stick sinks and comes
[[Page 480]]
to rest with its long axis positioned as close to vertical as possible.
(D) Align the angle measurement device alongside the dive stick
underwater and wait for the dive stick to come to rest if there is any
water disturbance. Determine whether the long axis of the dive stick is
greater than or less than 45 degrees from vertical.
(8) Dive sticks and similar articles described in
Sec. 1500.18(a)(18) in which the maximum force measured in the following
test method is less than 5-lbf [22N]. The test shall be conducted in the
ambient environment of the laboratory and not under water.
(i) Test equipment.
(A) A compression rig that has a force gauge or equivalent device
that is calibrated for force measurements within a minimum range of 0 to
5 lbf [0-22 N] and with an accuracy of 0.1 lbf
[0.44 N] or better. The test rig shall have a system to
guide this force application in the vertical direction and shall have a
means to adjust the rate of load application.
(B) Compression disk--the loading device that is attached to the
force gauge shall be a rigid metal disk with a minimum diameter of 1.125
inches [29 mm].
(C) Vise or other clamping device.
(ii) Testing procedure
(A) Position the bottom of the dive stick in the clamping device so
that the longest axis of the dive stick is vertical. The bottom end of
the dive stick is the end that sinks to the bottom of a pool of water.
Secure the bottom of the dive stick in the clamp such that the clamping
mechanism covers no more than the bottom \1/2\ inch [13 mm] of the dive
stick.
(B) Apply a downward force at a rate of 0.05 in/sec
(0.01 in/sec) [1.3 mm.sec 0.3 mm/sec] at the top
of the dive stick with the compression disk positioned so that the plane
of the disk contact surface is perpendicular to the long axis of the
dive stick.
(C) Apply the load for a period of 40 seconds or until the maximum
recorded force exceeds 5-lbf [22 N].
(D) Record the maximum force that was measured during the test.
(b) [Reserved]
[38 FR 27012, Sept. 27, 1973, as amended at 53 FR 46839, Nov. 18, 1988;
59 FR 9076, 9077, Feb. 25, 1994; 66 FR 13651, Mar. 7, 2001]
Sec. 1500.121 Labeling requirements; prominence, placement, and conspicuousness.
(a)(1) Background and scope. Section 2(p)(1) of the Federal
Hazardous Substances Act (FHSA) or ``the Act''), 15 U.S.C. 1261(p)(1),
requires that hazardous substances bear certain cautionary statements on
their labels. These statements include: signal words; affirmative
statements of the principal hazard(s) associated with a hazardous
substance; the common or usual name, or chemical name, of the hazardous
substance; the name and place of business of the manufacturer, packer,
distributor, or seller; statements of precautionary measures to follow;
instructions, when appropriate, for special handling and storage; the
statement ``Keep Out of the Reach of Children'' or its practical
equivalent; and, when appropriate, first-aid instructions. Section
2(p)(2) of the Act specifies that all such statements shall be located
prominently on the label of such a substance and shall appear in
conspicuous and legible type in contrast by typography, layout, or color
with other printed matter on the label. This regulation contains the
Commission's interpretations and policies for the type size and
placement of cautionary material on the labels of hazardous substances
and contains other criteria for such cautionary statements that are
acceptable to the Commission as satisfying section 2(p)(2) of the Act.
Labels that do not comply with this regulation may be considered
misbranded.
(2) Definitions. For the purposes of this section:
(i) Container means the immediate package from which a hazardous
substance may be dispensed and also any article, package or wrapping,
such as a tube or cone used for a firework or a wet cell battery casing
containing sulfuric acid, which is necessary for the substance to
function during actual use.
(ii) Cautionary material, cautionary labeling, and cautionary
labeling required
[[Page 481]]
by the Act mean all items of labeling information required by sections
2(p)(1) of the FHSA (repeated in 16 CFR 1500.3(b)(14)(i) or by the
regulations which require additional labeling under section 3(b) of the
Act.
(iii) Display panel means any surface of the immediate container,
and of any outer container or wrapping, which bears labeling.
(iv) Principal display panel means the portion(s) of the surface of
the immediate container, and of any outer container or wrapping, which
bear(s) the labeling designed to be most prominently displayed, shown,
presented, or examined under conditions of retail sale. (See paragraph
(c)(1) of this section.)
(v) Type size means the actual height of the printed image of each
upper case or capital letter as it appears on the label of a hazardous
substance. (See paragraph (c)(2) of this section.)
(vi) Signal word means the appropriate word ``DANGER,'' ``WARNING,''
or ``CAUTION,'' as required by sections 2(p)(1) (C) or (D) of the Act.
(vii) Statement of principal hazard(s) means that wording
descriptive of the principal or primary hazard(s) associated with a
hazardous substance required by section 2(p)(1)(E) of the Act. Some
examples of such statements are ``HARMFUL OR FATAL IF SWALLOWED,''
``VAPOR HARMFUL,'' ``FLAMMABLE,'' and ``SKIN AND EYE IRRITANT.''
(viii) Other cautionary material means all labeling statements,
other than ``signal words'' or ``statement(s) of principal hazard(s),''
required by the Act or by regulations issued under the Act.
(b) Prominent label placement. To satisfy the requirement of the Act
that cautionary labeling statements shall appear ``prominently'' on the
label of a hazardous substance, all such statements shall be placed on
the label as follows:
(1) Horizontal placement of labeling statements. Except for the name
and place of business of the manufacturer, packer, distributor, or
seller, all cautionary material required by the Act shall appear in
lines that are generally parallel to any base on which the package rests
as it is designed to be displayed for sale or, on display panels other
than the principal display panel, in lines generally parallel to all
other labeling on that panel. This requirement does not apply to
labeling on collapsible tubes, cylindrical containers with a narrow
diameter, or F-type containers where both the ``front'' and ``back'' of
the container are principal display panels. (See paragraph (e) of this
section.)
(2) Principal display panel labeling. (i) All items of cautionary
labeling required by the Act may appear on the principal display panel
on the immediate container and, if appropriate, on any other container
or wrapper. See paragraph (b)(4) of this section for requirements and
exceptions for labeling outer containers and wrappings.
(ii) The signal word, the statement of principal hazard(s), and, if
appropriate, instructions to read carefully any cautionary material that
may be placed elsewhere on the label shall be blocked together within a
square or rectangular area, with or without a border, on the principal
display panel on the immediate container and, where required by
paragraph (b)(4) of this section, on any outer container or wrapping.
All cautionary statements placed on the principal display panel shall be
separated on all sides from other printed or graphic matter, with the
exception of the declaration of net contents required under the Fair
Packaging and Labeling Act, 15 U.S.C. 1453(a) (2) and (3), by a border
line or by a space no smaller than the minimum allowable height of the
type size for cautionary material required by the Act (exclusive of
signal words and statements of hazard) on the principal display panel.
(iii) Depending on the design of the package or the configuration of
the label, or both, a package may have more than one principal display
panel. If so, each principal display panel must bear, at a minimum, the
signal word, statement of principal hazard or hazards, and, if
appropriate, instructions to read carefully any cautionary material that
may be placed elsewhere on the label.
(A) Where the principal display panel of the immediate container
consists of a lid, cap, or other item which may be
[[Page 482]]
separated from the immediate container and discarded, the container
shall be deemed to have a second principal display panel elsewhere on
the immediate container which must bear, at a minimum, the signal word,
statement of principal hazard(s), and instructions, if appropriate, to
read any cautionary material which may be placed elsewhere on the label.
(3) Prominent label placement--other display panel labeling. All
items of cautionary labeling required by the Act which do not appear on
the principal display panel shall be placed together on a display panel
elsewhere on the container. The name and place of business of the
manufacturer, packer, distributor, or seller may appear separately on
any display panel. Where cautionary material appears on a display panel
other than the principal display panel, the principal display panel
shall bear the statement ``Read carefully other cautions on the ------
panel,'' or its practical equivalent. [A description of the location of
the other panel is to be inserted in the blank space.]
(4) Outer container or wrappings. All cautionary labeling appearing
on the immediate container of a hazardous substance shall also appear on
any outer container or wrapping used in the retail display of the
substance, in the same manner as required for the immediate container.
Those cautionary labeling statements appearing on the immediate
container which are clearly legible through any outer container or
wrapper used in retail display need not appear on the outer container or
wrapping itself. (See section 2(n)(1) of the Act.)
(5) Placement of the word ``Poison'' and the skull and crossbones
symbol. The word ``poison'' and, when appropriate, the skull and
crossbones symbol shall appear on the label of a hazardous substance as
follows:
(i) If a hazardous substance is ``highly toxic,'' as defined in
Sec. 1500.3(c)(i) and section 2(h)(1) of the FHSA, the label must bear
the word ``poison'' in accordance with section 2(p)(1)(H) of the Act, in
addition to the signal word ``DANGER,'' and must also bear the skull and
crossbones symbol. Some products, under Sec. 1500.14(b) of the
regulations, may, in addition to any required signal word, be required
to bear the word ``poison'' and the skull and crossbones symbol because
of the special hazard associated with their ingredients. In both
instances, the word ``poison'' and the skull and crossbones symbol need
not appear on the principal display panel on the container, unless all
other cautionary labeling required by the Act appears on the principal
display panel. The word ``poison'' and the skull and crossbones symbol,
when required, must appear either together with other cautionary
labeling on a display panel other than the principal display panel or
together with the signal word and statement(s) of principal hazard on
the principal display panel.
(ii) Where, pursuant to a regulation issued under section 3(b) of
the Act, the label of a hazardous substance requires the word ``poison''
instead of a signal word, the word, ``POISON'' shall appear in capital
letters on the principal display panel, together with the statement(s)
of the principal hazard. Certain substances for which the word
``poison'' is required instead of any signal word are listed in
Sec. 1500.129.
(c) Conspicuousness--type size and style. To satisfy the requirement
that cautionary labeling statements under the Act be conspicuous and
legible, such statements shall conform to the following requirements:
(1) Area of principal display panel. The area of the principal
display panel is the area of the side or surface of the immediate
container, or of the side or surface of any outer container or wrapping,
that bears the labeling designed to be most prominently displayed,
shown, presented, or examined under conditions of retail sale. This area
is not limited to the portion of the surface covered with labeling;
rather, it includes the entire surface. Flanges at the tops and bottoms
of cans, conical shoulders of cans, handles, and shoulders and necks of
bottles and jars are excluded in measuring the area. For the purposes of
determining the proper type size for cautionary labeling, the area of
the principal display panel (or other panel bearing cautionary labeling,
under paragraph (c)(2)(ii) of this section) is to be computed as
follows:
[[Page 483]]
(i) In the case of a rectangular package, where one entire side is
the principal display panel, the product of the height times the width
of that side shall be the area of the principal display panel.
(ii) In the case of a cylindrical or nearly cylindrical container or
tube on which the principal display panel appears on the side, the area
of the principal display panel shall be 40 percent of the product of the
height of the container times its circumference.
(iii) In the case of any other shape of container, the area of the
principal display panel shall be 40 percent of the total surface of the
container, excluding those areas, such as flanges at tops and bottoms,
specified in paragraph (c)(1) above. However, if such a container
presents an obvious principal display panel (such as an oval or hour-
glass shaped area on the side of a container for dishwashing detergent),
the area to be measured shall be the entire area of the obvious
principal display panel.
(2) Type-size requirements. (i) The term type size refers to the
height of the actual printed image of each upper case or capital letter
as it appears on the label. The size of cautionary labeling shall be
reasonably related to the type size of any other printing appearing on
the same panel, but in any case must meet the minimum size requirements
in table 1.
(ii) When an item of labeling is required to be in a specified type
size, all upper case, or capital, letters must be at least equal in
height to the required type size, and all other letters must be the same
style as the upper case or capital letters. Unless otherwise specified
in the regulations (examples appear at Sec. Sec. 1500.14(b)(6), 1512.19,
1508.9, and part 1505), the type size of all cautionary statements
appearing on any display panel shall comply with the specifications in
table 1 when the area of the display panel is measured by the method in
paragraph (c)(1) above:
Table I
Area of principal display panel in square inches............. 0-2 *........................................ ..... ...... ....... ........ ........ .....
Signal word **............................................. \3/ \1/16\ \3/32\ \7/64\ \1/8\ \5/
64\ 32\
Statement of hazard........................................ \3/ \3/64\ \1/16\ \3/32\ \3/32\ \7/
64\ 64\
Other cautionary material ***.............................. \1/ \3/64\ \1/16\ \1/16\ \5/64\ \3/
32\ 32\
means ``greater than.''
* minimum height of printed image of capital or upper case letters.
** including the word ``poison'' when required instead of a signal word by Section 3(b) of the Act (Sec.
1500.129).
*** size of lettering for other cautionary material is based on the area of the display panel on which such
cautionary material appears.
(iii) If all of the required cautionary labeling does not appear on
the principal display panel, the statement to ``Read carefully other
cautions on the ------ panel,'' or its practical equivalent, must appear
in, as a minimum, the same type size as that required in table 1 for the
other cautionary material which appears elsewhere on the label of a
hazardous substance. The size of the cautionary labeling that does not
appear on the principal display panel is determined by the area of the
panel on which it does appear.
(3) Type style--proportion. The ratio of the height of a capital or
uppercase letter to its width shall be such that the height of the
letter is no more than 3 times its width.
(4) Signal word and statements of hazard--capital letters. The
signal word, the word ``poison'' if required instead of a signal word
(see Sec. 1500.129), and the statement of principal hazard or hazards
shall be in capital letters.
(5) Multiple statement of hazard--type size and style. All
statements of principal hazard or hazards on a label shall appear in the
same size and style of type, and shall appear in the same color or have
the same degree of boldness.
(6) Accompanying literature containing directions for use. Where
literature accompanying the package of a hazardous substance has
directions for use, written or otherwise, section 2(n) of the Act
requires the literature to bear cautionary labeling.
[[Page 484]]
(i) All such cautionary labeling shall be in reasonable proximity to
any direction for use and shall be placed together within the same
general area.
(ii) The type size of such cautionary labeling shall be reasonably
related to the type size of any other printed matter in the accompanying
literature and must be in conspicuous and legible type by typography,
layout, or color with other printed matter on the label. The signal word
and statement of principal hazard or hazards shall appear in capital
letters.
(d) Conspicuousness--contrast. To satisfy the requirement that
cautionary labeling statements appear in conspicuous and legible type
which is in contrast by typography, layout, or color with the other
printed matter on the label, such statements shall conform to the
following requirements:
(1) Color. Where color is the primary method used to achieve
appropriate contrast, the color of any cautionary labeling statement
shall be in sharp contrast with the color of the background upon which
such a statement appears. Examples of combinations of colors which may
not satisfy the requirement for sharp contrast are: black letters on a
dark blue or dark green background, dark red letters on a light red
background, light red letters on a reflective silver background, and
white letters on a light gray or tan background.
(2) Interference with conspicuousness--labeling design, vignettes,
or other printed material. For cautionary information appearing on
panels other than the principal display panel, the label design, the use
of vignettes, or the proximity of other labeling or lettering shall not
be such that any cautionary labeling statement is obscured or rendered
inconspicuous.
(e) Collapsible metal tubes. Collapsible metal tubes containing
hazardous substances shall be labeled so that all cautionary labeling
required by the Act appears as close to the dispensing end of the
container as possible. The placement and conspicuousness of these
statements shall conform to the provisions of paragraphs (b), (c), and
(d) of this section.
(f) Unpackaged hazardous substances. Where practicable, unpackaged
hazardous substances intended, or distributed in a form suitable, for
use in or around a household or by children shall be labeled so that all
items of information required by the Act appear upon the article itself.
In instances where this is impracticable (for example, because of the
size or nature of the article), the required cautionary labeling must be
displayed by means of a tag or other suitable material that is no less
than five square inches in area and is securely affixed to the article
so that the labeling will remain attached throughout conditions of
merchandising and distribution to the ultimate consumer. The placement
and conspicuousness of all cautionary labeling appearing on such a tag
or material, or on an unpackaged article, shall conform to the
provisions of paragraphs (b), (c), and (d) of this section. For the
purposes of determining the proper type size to use on a tag or other
material, the area of one side of the tag or other material shall be the
area of the principal display panel.
(g) Exemptions. All requirements of the Act are satisfied by
compliance with this Sec. 1500.121. However, exemptions can be granted
under section 3(c) of the Act and Sec. 1500.83, or under the provisions
of another statute should this section be incorporated in regulations
under another statute. Section 1500.82 contains the requirements for
exemption requests under the Federal Hazardous Substances Act.
(h) Effective date. The provisions of this rule apply to hazardous
substances bearing labels printed after December 30, 1985. Labels
printed prior to the effective date of this rule may be applied until
not later than December 28, 1987. This rule applies to all hazardous
substances to which labels are applied after December 28, 1987.
[49 FR 50383, Dec. 28, 1984]
Sec. 1500.122 Deceptive use of disclaimers.
A hazardous substance shall not be deemed to have met the
requirements of section 2(p) (1) and (2) of the act (repeated in
Sec. 1500.3(b)(14) (i) and (ii)) if there appears in or on the label (or
in any accompanying literature; words, statements, designs, or other
graphic material that in any manner negates
[[Page 485]]
or disclaims any of the label statements required by the act; for
example, the statement ``Harmless'' or ``Safe around pets'' on a toxic
or irritant substance.
Sec. 1500.123 Condensation of label information.
Whenever the statement of the principal hazard or hazards itself
provides the precautionary measures to be followed or avoided, a clear
statement of the principal hazard will satisfy the requirements of
section 2(p)(1) (E) and (F) of the act (repeated in
Sec. 1500.3(b)(14)(i) (E) and (F)). When the statement of precautionary
measures in effect provides instruction for first-aid treatment, the
statement of the precautionary measures will satisfy the requirements of
section 2(p)(1) (F) and (G) of the act (repeated in
Sec. 1500.3(b)(14)(i) (F) and (G)).
Sec. 1500.125 Labeling requirements for accompanying literature.
When any accompanying literature includes or bears any directions
for use (by printed word, picture, design, or combination thereof), such
placard, pamphlet, booklet, book, sign, or other graphic or visual
device shall bear all the information required by section 2(p) of the
act (repeated in Sec. 1500.3(b)(14)).
Sec. 1500.126 Substances determined to be ``special hazards.''
Whenever the Commission determines that for a particular hazardous
substance intended or packaged in a form suitable for use in the
household or by children, the requirements of section 2(p) of the act
(repeated in Sec. 1500.3(b)(14)) are not adequate for the protection of
the public health and safety because of some special hazard, the
Commission, by an appropriate order in the Federal Register, shall
specify such reasonable variations or additional label requirements that
it finds are necessary for the protection of the public health and
safety. Such order shall specify a date that is not less than 90 days
after the order is published (unless emergency conditions stated in the
order specify an earlier date) after which any such hazardous substance
intended, or packaged in a form suitable, for use in the household or by
children that fails to bear a label in accordance with such order shall
be deemed to be a misbranded hazardous substance.
Sec. 1500.127 Substances with multiple hazards.
(a) Any article that presents more than one type of hazard (for
example, if the article is both toxic and flammable) must be labeled
with: An affirmative statement of each such hazard; the precautionary
measures describing the action to be followed or avoided for each such
hazard; instructions, when necessary or appropriate, for first-aid
treatment of persons suffering from the ill effects that may result from
each such hazard; instructions for handling and storage of articles that
require special care in handling and storage because of more than one
type of hazard presented by the article; and the common or usual name
(or the chemical name if there is no common or usual name) for each
hazardous component present in the article.
(b) Label information referring to the possibility of one hazard may
be combined with parallel information concerning any additional hazards
presented by the article if the resulting condensed statement contains
all of the information needed for dealing with each type of hazard
presented by the article.
[38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973]
Sec. 1500.128 Label comment.
The Commission will offer informal comment on any proposed label and
accompanying literature involving a hazardous substance if furnished
with:
(a) Complete labeling or proposed labeling, which may be in draft
form.
(b) Complete quantitative formula.
(c) Adequate clinical pharmacological, toxicological, physical, and
chemical data applicable to the possible hazard of the substance.
(d) Any other information available that would facilitate
preparation of a suitable label, such as complaints of injuries
resulting from the product's use or other evidence that would furnish
human-experience data.
[[Page 486]]
Sec. 1500.129 Substances named in the Federal Caustic Poison Act.
The Commission finds that for those substances covered by the
Federal Caustic Poison Act (44 Stat. 1406), the requirements of section
2(p)(1) of the Federal Hazardous Substances Act (repeated in
Sec. 1500.3(b)(14)(i)) are not adequate for the protection of the public
health. Labeling for those substances, in the concentrations listed in
the Federal Caustic Poison Act, were required to bear the signal word
``poison.'' The Commission concludes that the lack of the designation
``poison'' would indicate to the consumer a lesser hazard and that such
would not be in the interest of the public health. Under the authority
granted in section 3(b) of the act, the Commission therefore finds that
for the following substances, and at the following concentrations, the
word ``poison'' is necessary instead of any signal word:
(a) Hydrochloric acid and any preparation containing free or
chemically unneutralized hydrochloric acid (HCl) in a concentration of
10 percent or more.
(b) Sulfuric acid and any preparation containing free or chemically
unneutralized sulfuric acid (H2 SO4) in a
concentration of 10 percent or more.
(c) Nitric acid or any preparation containing free or chemically
unneutralized nitric acid (HNO3) in a concentration of 5
percent or more.
(d) Carbolic acid (C6 H5 OH), also known as
phenol, and any preparation containing carbolic acid in a concentration
of 5 percent or more.
(e) Oxalic acid and any preparation containing free or chemically
unneutralized oxalic acid (H2 C2 O4) in
a concentration of 10 percent or more.
(f) Any salt of oxalic acid and any preparation containing any such
salt in a concentration of 10 percent or more.
(g) Acetic acid or any preparation containing free or chemically
unneutralized acetic acid (HC2 H2 O2)
in a concentration of 20 percent or more.
(h) Hypochlorous acid, either free or combined, and any preparation
containing the same in a concentration that will yield 10 percent or
more by weight of available chlorine.
(i) Potassium hydroxide and any preparation containing free or
chemically unneutralized potassium hydroxide (KOH), including caustic
potash and vienna paste (vienna caustic), in a concentration of 10
percent or more.
(j) Sodium hydroxide and any preparation containing free or
chemically unneutralized sodium hydroxide (NaOH), including caustic soda
and lye in a concentration of 10 percent or more.
(k) Silver nitrate, sometimes known as lunar caustic, and any
preparation containing silver nitrate (AgNO3) in a
concentration of 5 percent or more.
(l) Ammonia water and any preparation containing free or chemically
uncombined ammonia (NH3), including ammonium hydroxide and
``hartshorn,'' in a concentration of 5 percent or more.
Sec. 1500.130 Self-pressurized containers: labeling.
(a) Self-pressurized containers that fail to bear a warning
statement adequate for the protection of the public health and safety
may be misbranded under the act, except as otherwise provided pursuant
to section 3 of the act.
(b) The following warning statement will be considered as meeting
the requirements of section 2(p)(1) of the act (repeated in
Sec. 1500.3(b)(14)(i)) if the only hazard associated with an article is
that the contents are under pressure:
warning--contents under pressure
Do not puncture or incinerate container. Do not expose to heat or
store at temperatures above 120 deg.F. Keep out of the reach of
children.
The word ``CAUTION'' may be substituted for the word ``WARNING''. A
practical equivalent may be substituted for the statement ``Keep out of
the reach of children.''
(c) That portion of the warning statement set forth in paragraph (b)
of this section in capital letters should be printed on the main (front)
panel of the container in capital letters of the type size specified in
Sec. 1500.121(c). The balance of the cautionary statements may appear
together on another panel if the front panel also bears a statement such
as ``Read carefully other cautions on ---------- panel.''
[[Page 487]]
(d) If an article has additional hazards, such as skin or eye
irritancy, toxicity, or flammability, appropriate additional front and
rear panel precautionary labeling is required.
Sec. 1500.133 Extremely flammable contact adhesives; labeling.
(a) Extremely flammable contact adhesives, also known as contact
bonding cements, when distributed in containers intended or suitable for
household use may be misbranded under the act if the containers fail to
bear a warning statement adequate for the protection of the public
health and safety.
(b) The following warning statement is considered as the minimum
cautionary labeling adequate to meet the requirements of section 2(p)(1)
of the act (repeated in Sec. 1500.3(b)(14)(i)) with respect to
containers of more than one-half pint of contact adhesive and similar
liquid or semiliquid articles having a flashpoint at or below 20 deg.F.
as determined by the method in Sec. 1500.43, when the only hazard
foreseeable is that caused by the extreme flammability of the mixture:
Danger
Extremely Flammable
Vapors May Cause Flash Fire
Vapors may ignite explosively.
Prevent buildup of vapors--open all windows and doors--use only with
cross-ventilation.
Keep away from heat, sparks, and open flame.
Do not smoke, extinguish all flames and pilot lights, and turn off
stoves, heaters, electric motors, and other sources of ignition during
use and until all vapors are gone.
Close container after use.
Keep out of the reach of children.
(c) The words that are in capital letters in the warning statement
set forth in paragraph (b) of this section should be printed on the main
(front) panel or panels of the container in capital letters of the type
size specified in Sec. 1500.121(c). The balance of the cautionary
information may appear together on another panel provided the front
panel bears a statement such as ``Read carefully other cautions on ----
-- panel,'' the blank being filled in with the identification of the
specific label panel bearing the balance of the cautionary labeling. It
is recommended that a borderline be used in conjunction with the
cautionary labeling.
(d) If an article has additional hazards, or contains ingredients
listed in Sec. 1500.14 as requiring special labeling, appropriate
additional front and rear panel precautionary labeling is required.
(e) Since the Commission has issued a regulation banning under the
Consumer Product Safety Act extremely flammable contact adhesives
covered by this labeling regulation (sec. 16 CFR part 1302), paragraphs
(a), (b), (c) and (d) of this section are revoked as to the subject
products after June 13, 1978.
[38 FR 27012, Sept. 27, 1973, as amended at 42 FR 63742, Dec. 19, 1977]
Sec. 1500.134 Policy on first aid labeling for saline emesis.
(a) This section states the Consumer Product Safety Commission's
policy concerning first aid instructions for the use of a salt solution
to induce vomiting (saline emesis) in the event of ingestion of
hazardous substances.
(b) In many cases where hazardous substances are ingested, the
recommended first aid instructions for inducing vomiting have contained
a statement that this should be accomplished by drinking a solution of
salt (sodium chloride) in warm water. At one time, this direction was
considered medically acceptable. However, the Commission has obtained
information showing that the instruction to perform saline emesis is no
longer appropriate. This is because the use of salt to induce vomiting
can cause severe hypernatremia (salt poisoning) with potentially toxic
effects, particularly in children 5 years old or younger, the age group
most often involved in accidental poisonings. In view of the
availability of safer and more effective emetics such as ipecac syrup,
the Commission no longer recommends a direction to perform saline emesis
as a first aid direction for inducing vomiting.
(c) The Commission believes that, for products for which directions
for saline emesis have been given in the past, ipecac syrup, U.S.P., is
the most appropriate emetic, unless a particular contraindication exists
in connection with any particular hazardous substance.
[[Page 488]]
(d) The Commission wishes to emphasize that this policy does not
require that any specific first aid instruction or wording be used.
Where appropriate, the label may include directions (1) that the victim
immediately contact a doctor or poison control center and/or (2) that
vomiting be induced using methods other than salt. It is, of course, the
manufacturer's responsibility to insure that the label provides enough
information in addition to first aid instructions to fulfill all other
labeling required by statute or regulation.
(Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a)))
[43 FR 33704, Aug. 1, 1978]
Sec. 1500.135 Summary of guidelines for determining chronic toxicity.
A substance may be toxic due to a risk of a chronic hazard. (A
regulatory definition of ``toxic'' that pertains to chronic toxicity may
be found at 16 CFR 1500.3(c)(2).) The following discussions are intended
to help clarify the complex issues involved in assessing risk from
substances that may potentially cause chronic hazards and, where
possible, to describe conditions under which substances should be
considered toxic due to a risk of the specified chronic hazards. The
guidelines are not intended to be a static classification system, but
should be considered along with available data and with expert judgment.
They are not mandatory. Rather, the guidelines are intended as an aid to
manufacturers in determining whether a product subject to the FHSA
presents a chronic hazard. All default assumptions contained in the
guidelines on hazard and risk determination are subject to replacement
when alternatives which are supported by appropriate data become
available. The following are brief summaries of more extensive
discussions contained in the guidelines. Thus, the guidelines should be
consulted in conjunction with these summaries. Copies of the guidelines
may be obtained from the Office of Compliance and Enforcement, Consumer
Product Safety Commission, Washington, DC 20207. (In addition to the
chronic hazards discussed below, issues relating to the chronic hazard
of sensitization are discussed in 16 CFR 1500.3(c)(5).)
(a) Carcinogenicity. Substances are toxic by reason of their
potential carcinogenicity in humans when they are known or probable
human carcinogenic substances as defined below. Substances that are
possible human carcinogenic substances or for which there is no evidence
of carcinogenic effect under the following categories lack sufficient
evidence to be considered toxic by virtue of their potential
carcinogenicity.
(1) Known Human carcinogenic Substances (``sufficient evidence'' in
humans). Substances are toxic by reason of their carcinogenicity when
they meet the ``sufficient evidence'' criteria of carcinogenicity from
studies in humans, which require that a causal relationship between
exposure to an agent and cancer be established. This category is similar
to the Environmental Protection Agency's (EPA) Group A, the
International Agency for Research on Cancer's (IARC) Group 1, or the
American National Standards Institute's (ANSI) Category 1. A causal
relationship is established if one or more epidemiological
investigations that meet the following criteria show an association
between cancer and exposure to the agent.
(i) No identified bias that can account for the observed association
has been found on evaluation of the evidence.
(ii) All possible confounding factors which could account for the
observed association can be ruled out with reasonable confidence.
(iii) Based on statistical analysis, the association has been shown
unlikely to be due to chance.
(2) Probable Human Carcinogenic Substances. Substances are also
toxic by reason of their probable carcinogenicity when they meet the
``limited evidence'' criteria of carcinogenicity in humans or the
``sufficient evidence'' criteria of carcinogenicity in animals described
below. This category is similar to EPA's Group B, IARC's Group 2, or
ANSI's Categories 2 and 3. Evidence derived from animal studies that has
been shown not to be relevant to humans is not included. For example,
such evidence would result when there
[[Page 489]]
was an identified mechanism of action for a chemical that causes cancer
in animals that has been shown not to apply to the human situation. It
is reasonable, for practical purposes, to regard an agent for which
there is ``sufficient'' evidence of carcinogenicity in animals as if it
presented a carcinogenic risk to humans.
(i) ``Limited evidence'' of carcinogenicity in humans. The evidence
is considered limited for establishing a causal relationship between
exposure to the agent and cancer when a causal interpretation is
credible, but chance, bias, or other confounding factors could not be
ruled out with reasonable confidence.
(ii) ``Sufficient evidence'' of carcinogenicity in animals.
Sufficient evidence of carcinogenicity requires that the substance has
been tested in well-designed and -conducted studies (e.g., as conducted
by National Toxicology Program (NTP), or consistent with the Office of
Science Technology Assessment and Policy (OSTP) guidelines) and has been
found to elicit a statistically significant (p <0.05) exposure-related
increase in the incidence of malignant tumors, combined malignant and
benign tumors, or benign tumors if there is an indication of the ability
of such benign tumors to progress to malignancy:
(A) In one or both sexes of multiple species, strains, or sites of
independent origin; or experiments using different routes of
administration or dose levels; or
(B) To an unusual degree in a single experiment (one species/strain/
sex) with regard to unusual tumor type, unusual tumor site, or early age
at onset of the tumor.
The presence of positive effects in short-term tests, dose-response
effects data, or structure-activity relationship are considered
additional evidence.
(3) Possible Human Carcinogenic Substance (``limited evidence''
animal carcinogen). In the absence of ``sufficient'' or ``limited''
human data, agents with ``limited'' evidence of carcinogenicity from
animal studies fall into this category. Such substances, and those that
do not fall into any other group, are not considered ``toxic.'' This
does not imply that the substances are or are not carcinogens, only that
the evidence is too uncertain to provide for a determination. This
category is similar to EPA's Group C, IARC's Group 3, or ANSI's category
4.
(b) Neurotoxicity. Substances are toxic by reason of their potential
neurotoxicity in humans when they meet the ``sufficient evidence'' or
``limited evidence'' criteria of neurotoxicity in humans, or when they
meet the ``sufficient evidence'' criteria of neurotoxicity in animals.
(1) Known Neurotoxic Substances (``sufficient evidence in humans'').
Substances are toxic by reason of their neurotoxicity and are considered
``known neurotoxic substances'' when they meet the ``sufficient
evidence'' criteria of neurotoxicity derived from studies in humans
which require that a causal association between exposure to an agent and
neurotoxicity be established with a reasonable degree of certainty.
Substances in this category meet the definition of ``neurotoxic'' as
stated above. ``Sufficient evidence,'' derived from human studies, for a
causal association between exposure to a chemical and neurotoxicity is
considered to exist if the studies meet the following criteria.
(i) A consistent pattern of neurological dysfunction is observed.
(ii) The adverse effects/lesions account for the neurobehavioral
dysfunction with reasonable certainty.
(iii) All identifiable bias and confounding factors are reasonably
discounted after consideration.
(iv) The association has been shown unlikely to be due to chance,
based on statistical analysis.
(2) Probable Neurotoxic Substances. Substances are also toxic by
reason of their probable neurotoxicity when they meet the ``limited
evidence'' criteria of neurotoxicity in humans, or the ``sufficient
evidence'' criteria derived from animal studies. Evidence derived from
animal studies that has been shown not to be relevant to humans is not
included. Such evidence would result, for example, when there was an
identified mechanism of action for a chemical that causes neurotoxicity
in animals that has been shown not to apply to the human situation.
[[Page 490]]
(i) ``Limited evidence'' of neurotoxicity in humans. The evidence
derived from human studies is considered limited for neurotoxicity when
the evidence is less than convincing, i.e., one of the criteria of
``sufficient evidence'' of neurotoxicity for establishing a causal
association between exposure to the agent and neurotoxicity is not met,
leaving some uncertainties in establishing a causal association.
(ii) ``Sufficient evidence'' of neurotoxicity in animals. Sufficient
evidence of neurotoxicity derived from animal studies for a causal
association between exposure to a chemical and neurotoxicity requires
that:
(A) The substance has been tested in well-designed and -conducted
studies (e.g., NTP's neurobehavioral battery, or conforming to EPA's
neurotoxicity test guidelines); and
(B) The substance has been found to elicit a statistically
significant (p <0.05) increase in any neurotoxic effect in one or both
sexes of multiple species, strains, or experiments using different
routes of administration and dose-levels.
(3) Possible Neurotoxic Substances. ``Possible neurotoxic
substances'' are the substances which meet the ``limited evidence''
criteria of neurotoxicity evidence derived from animal studies in the
absence of human data, or in the presence of inadequate human data, or
data which do not fall into any other group. Substances in this category
are not considered ``toxic.''
(c) Developmental and Reproductive Toxicity--(1) Definitions of
``Sufficient'' and ``Limited'' Evidence. The following definitions apply
to all categories stated below.
(i) ``Sufficient evidence'' from human studies for a causal
association between human exposure and the subsequent occurrence of
developmental or reproductive toxicity is considered to exist if the
studies meet the following criteria:
(A) No identified bias that can account for the observed association
has been found on evaluation of the evidence.
(B) All possible confounding factors which could account for the
observed association can be ruled out with reasonable confidence.
(C) Based on statistical analysis, the association has been shown
unlikely to be due to chance.
(ii) ``Limited evidence'' from human studies exists when the human
epidemiology meets all but one of the criteria for ``sufficient
evidence''; i.e., the statistical evidence is borderline as opposed to
clear-cut, there is a source of bias, or there are confounding factors
that have not been and cannot be accounted for.
(iii) ``Sufficient evidence'' from animal studies exists when
(A) Obtained from a good quality animal study; and
(B) The substance has been found to elicit a statistically
significant (p<0.05) treatment-related increase in multiple endpoints in
a single species/strain, or in the incidence of a single endpoint at
multiple dose levels or with multiple routes of administration in a
single species/strain, or increase in the incidence of a single endpoint
in multiple species/strains/ experiments.
(iv) ``Limited evidence'' from animal studies exists when:
(A) Obtained from a good quality study and there is a statistically
significant (p<0.05) treatment-related increase in the incidence of a
single endpoint in a single species/strain/experiment at a single dose
level administered through only one route and such evidence otherwise
does not meet the criteria for ``sufficient evidence''; or
(B) The evidence is derived from studies which can be interpreted to
show positive effects but have some qualitative or quantitative
limitations with respect to experimental procedures (e.g., doses,
exposure, follow-up, number of animals/group, reporting of the data,
etc.) which would prevent classification of the evidence in the group of
``sufficient evidence.''
(2) Developmental Toxicants. Substances are toxic by reason of their
potential developmental or reproductive toxicity when they meet the
``sufficient evidence'' or ``limited evidence'' criteria of
developmental or reproductive toxicity in humans, or when they meet the
``sufficient evidence'' criteria of developmental or reproductive
toxicity in animals. The Food and Drug Administration (FDA) and the
European Economic Community (EEC) have
[[Page 491]]
developed categories for teratogens but not other developmental
toxicants. The teratogen guidelines limit the information only to
structural birth defects and do not include other hazards of
developmental toxicity such as embryonal death, fetal death, or
functional deficiencies which are also important in assessing the
overall toxicity of a substance when administered during pregnancy.
Recently, EPA has proposed a system for classifying developmental
toxicity. The Occupational Safety and Health Administration (OSHA) has
not yet developed any classification for developmental toxicity. The
commission has established the following categories for determination of
developmental toxicity according to the available evidence.
(i) Known Human Developmental Toxicant (``sufficient evidence in
humans''). A substance is considered a ``known human developmental
toxicant'' if there is ``sufficient'' human evidence to establish a
causal association between human exposure and the subsequent occurrence
of developmental toxicity manifested by death of the conceptus (embryo
or fetus), or structural or functional birth defects. This category
(Human Developmental Toxicant) is comparable to category 1 of the EEC
and categories D and X of FDA, except that these guidelines are limited
to teratogens. This category is also comparable to the category
``definitive evidence for human developmental toxicity'' proposed by
EPA.
(ii) Probable Human Developmental Toxicant. A substance is
considered a ``probable human developmental toxicant'' if there is
``limited'' human evidence or ``sufficient'' animal evidence to
establish a causal association between human exposure and subsequent
occurrence of developmental toxicity. This group (Probable Human
Developmental Toxicant) is comparable to the category ``adequate
evidence for human developmental toxicity'' proposed by EPA. This
category is also comparable to category 2 of the EEC and category A1 of
FDA, except that these guidelines are limited to teratogens.
(iii) Possible Human Developmental Toxicant. A substance is
considered a ``possible human developmental toxicant'' if there is
``limited'' animal evidence, in the absence of human data, or in the
presence of inadequate human data, or which does not fall into any other
group, to establish a causal association between human exposure and
subsequent occurrence of developmental toxicity. EEC, FDA, and EPA have
not developed a category comparable to this group. The Commission
believes that data from well planned animal studies are important to
consider even though they may provide only limited evidence of
developmental toxicity.
(3) Male Reproductive Toxicants. Male reproductive toxicants can be
grouped into the following different categories based on evidence
obtained from human or animal studies.
(i) Known Human Male Reproductive Toxicant. A substance is
considered a ``known human male reproductive toxicant'' if there is
``sufficient'' human evidence to establish a causal association between
human exposure and the adverse effects on male reproductive main
endpoints which are mating ability, fertility, and prenatal and
postnatal development of the conceptus. This category is comparable to
the one termed ``Known Positive'' in the EPA guidelines on male
reproductive risk assessment.
(ii) Probable Human Male Reproductive Toxicant. A substance is
considered a ``probable human male reproductive toxicant'' if there is
``limited'' human evidence or ``sufficient'' animal evidence to
establish a causal association between human exposure and the adverse
effects on male reproductive main endpoints. This category is comparable
to the one termed ``Probable Positive'' in the EPA guidelines on male
reproductive risk assessment. However, the EPA category is based only on
sufficient animal evidence. CPSC believes that limited human evidence is
also sufficient for a chemical to be placed in this category.
(iii) Possible Human Male Reproductive Toxicant. A substance is
considered a ``possible human male reproductive toxicant'' if there is
limited animal evidence, in the absence of human data, or in the
presence of inadequate human data, or which does not fall into any other
group, to establish a causal
[[Page 492]]
association between human exposure and adverse effects on male
reproductive main endpoints. This category is comparable to the one
termed ``Possible Positive A'' in the EPA guidelines on male
reproductive risk assessment. EPA proposes to use either limited human
or limited animal evidence data to classify a toxicant as a ``Possible
Positive A'' toxicant. As described above, CPSC would elevate limited
human evidence to the category ``Probable Human Male Reproductive
Toxicant.''
(4) Female Reproductive Toxicants. Female reproductive toxicants can
be grouped into the following different categories based on evidence
obtained from human or animal studies. EPA has proposed guidelines for
assessing female reproductive risk but has not yet proposed a specific
system for categorization of female reproductive toxicants.
(i) Known Human Female Reproductive Toxicant. A substance is
considered a ``known human female reproductive toxicant'' if there is
``sufficient'' human evidence to establish a causal association between
human exposure and adverse effects on female reproductive function such
as mating ability, fertility, and prenatal and postnatal development of
the conceptus.
(ii) Probable Human Female Reproductive Toxicant. A substance is
considered a ``probable human female reproductive toxicant'' if there is
``limited'' human evidence or ``sufficient'' animal evidence to
establish a causal association between human exposure and adverse
effects on female reproductive function.
(iii) Possible Human Female Reproductive Toxicant. A substance is
considered a ``possible human female reproductive toxicant'' if there is
``limited'' animal evidence, in the absence of human data, or in the
presence of inadequate human data, or which does not fall into any other
group, to establish a causal association between human exposure and
adverse effects on female reproductive function.
(d) Other Subjects Related to the Determination that a Substance is
Toxic. Under the FHSA, for a toxic substance to be considered hazardous,
it must not only have the potential to be hazardous but there must also
be the potential that persons are exposed to the substance, that the
substance can enter the body, and that there is a significant risk of an
adverse health effect associated with the customary handling and use of
the substance. Under these guidelines, existence of an adverse health
effect means that such exposure is above the ``acceptable daily intake''
(``ADI''). The ADI is based on the risks posed by the substance, and
whether they are acceptable under the FHSA. This section addresses those
issues by providing guidelines concerning assessment of exposure,
assessment of bioavailability, determination of acceptable risks and the
ADI to children and adults, and assessment of risk.
(1) Assessment of Exposure. An exposure assessment may comprise a
single exposure scenario or a distribution of exposures. Reasonably
foreseeable use, as well as accidental exposure, should be taken into
consideration when designing exposure studies. The following guidelines
should be used in the assessment of exposure.
(i) Inhalation. Inhalation studies to assess exposure should be
reliable studies using direct monitoring of populations, predictions of
exposure through modeling, or surrogate data.
(A) Direct Monitoring. Populations to be monitored should be
selected randomly to be representative of the general population, unless
the exposure of a particular subset population is the desired goal of
the assessment. The monitoring technique should be appropriate for the
health effect of interest.
(B) Modeling. Predictions of exposure to a chemical using
mathematical models can be based on physical and chemical principles,
such as mass balance principles. Mass balance models should consider the
source strength of the product of interest, housing characteristics, and
ambient conditions likely to be encountered by the studied population.
(C) Surrogate Data. Surrogate data should only be used when data
concerning the chemical of interest are sparse or unavailable and when
there is a reasonable assurance that the surrogate data will accurately
represent the chemical of interest.
[[Page 493]]
(ii) Oral Ingestion. Oral ingestion studies may involve direct
monitoring of sources of chemicals as well as laboratory simulations.
The estimation of exposure from ingestion of chemicals present in
consumer products is predicted based upon estimates of use of the
product and absorption of the chemical from the gastrointestinal tract.
The following criteria should be established for laboratory simulations
to estimate exposure:
(A) A simulant or range of simulants should be carefully selected to
mimic the possible range of conditions which occur in humans, such as
full and empty stomachs, or various saliva compositions at different
times of the day.
(B) The mechanical action to which a product is submitted must be
chosen to represent some range of realistic conditions to which a human
may subject the product.
(iii) Dermal Exposure. (A) Dermal exposure involves estimating the
amount of substance contacting the skin. This may involve experiments
measuring the amount of material leached from a product contacting a
liquid layer which interfaces with the skin, or the amount of substance
which migrates from a product (in solid or liquid form) which is in
contact with the skin.
(B) Parameters to be considered include: Surface area of the skin
contacted, duration of contact, frequency of contact, and thickness of a
liquid interfacial layer.
(2) Assessment of Bioavailability. (i) The need to consider
bioavailability in estimating the risk from use of a product containing
a toxic substance only arises when it is anticipated that the absorption
characteristics of a substance to which there is human exposure will
differ from those characteristics for the substance tested in the
studies used to define the dose-response relationship.
(ii) In determining the need to assess bioavailability, the factors
to be examined include:
(A) The physical or chemical form of the substance,
(B) The route of exposure (inhalation, ingestion, or through the
skin),
(C) The presence of other constituents in the product which
interfere with or alter absorption of the toxic substance, and
(D) Dose.
(3) Assessment of Risk. This section on quantitative risk assessment
applies to estimates of risk for substances that are toxic by reason of
their carcinogenicity.
(i) Generally, the study leading to the highest risk should be used
in the risk assessment; however, other factors may influence the choice
of study.
(ii) Risk should be based on the maximum likelihood estimate from a
multistage model (such as Global83 or later version) unless the maximum
likelihood estimate is not linear at low dose, in which case the 95%
upper confidence limit on risk should be used.
(iii) For systemic carcinogens, if estimates of human risk are made
based on animal data, a factor derived from dividing the assumed human
weight (70 kg) by the average animal weight during the study and taking
that to the \1/3\ power should be used. There is the possibility that
this factor may be changed, using the \1/4\ power instead of the \1/3\
power, as part of a unified Federal regulatory approach. If such an
approach is adopted, it will apply here.
(iv) When dose is expressed as parts per million, and the carcinogen
acts at the site of contact, humans and animals exposed to the same
amount for the same proportion of lifetime should be assumed to be
equally sensitive.
(v) If no experimental study having the same route of exposure as
that anticipated for human use of a substance is available, a study by
another route of exposure may be used. Pharmacokinetic methods may be
used if sufficient data are available.
(vi) When exposure scenarios are different from those used in the
underlying study upon which estimates of risk are based, proportionality
should be applied. If pharmacokinetic methods are used to adjust for
risks at high versus low exposure levels, level-time measures should not
be combined without taking the non-linearity into account.
(4) Acceptable Risks--(i) ADI for Carcinogens. The maximum
acceptable daily intake (``ADI'') is that exposure of a toxic (by virtue
of its carcinogenicity) substance that is estimated
[[Page 494]]
to lead to a lifetime excess risk of one in a million. Exposure refers
to the anticipated exposure from normal lifetime use of the product,
including use as a child as well as use as an adult.
(ii) ADI for Neurotoxicological and Developmental/Reproductive
Agents. Due to the difficulties in using a numerical risk assessment
method to determine risk for neurotoxicological or developmental/
reproductive toxicants, the Commission is using a safety factor
approach, as explained below.
(A) Human Data. If the hazard is ascertained from human data, a
safety factor of ten will be applied to the lowest No Observed Effect
Level (``NOEL'') seen among the relevant studies. If no NOEL can be
determined, a safety factor of 100 will be applied to the Lowest
Observed Effect Level (``LOEL''). Both the NOEL and LOEL are defined in
terms of daily dose level.
(B) Animal Data. If the hazard is ascertained from animal data, a
safety factor of one hundred will be applied to the lowest NOEL. If no
NOEL can be determined, a safety factor of one thousand will be applied
to the lowest LOEL. Both the NOEL and LOEL are defined in terms of daily
dose level.
[57 FR 46665, Oct. 9, 1992]
Sec. 1500.210 Responsibility.
The provisions of these regulations (16 CFR subchapter C of chapter
II) with respect to the doing of any act shall be applicable also to the
causing of such act to be done.
Sec. 1500.211 Guaranty.
In the case of the giving of a guaranty or undertaking referred to
in section 5(b)(2) of the act, each person signing such guaranty or
undertaking, or causing it to be signed, shall be considered to have
given it. Each person causing a guaranty or undertaking to be false is
chargeable with violations of section 4(d) of the act.
Sec. 1500.212 Definition of guaranty; suggested forms.
(a) A guaranty or undertaking referred to in section 5(b)(2) of the
act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment of delivery; or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered, or caused
to be shipped or delivered, by the person who gives the guaranty of
undertaking.
(b) The following are suggested forms of guaranty or undertaking
referred to in section 5(b)(2) of the act.
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking)
hereby guarantees that no article listed herein is misbranded within the
meaning of the Federal Hazardous Substances Act.
(Signature and post-office address of person giving the guaranty or
undertaking)
(2) General and continuing forms.
The article comprising each shipment or other delivery hereafter made by
----------
(Name of person giving the guaranty or undertaking)
to, or on the order of --------------------
(Name and post-office address of person to whom the guaranty or
undertaking is given)
is hereby guaranteed, as of the date of such shipment or delivery, to
be, on such date, not misbranded within the meaning of the Federal
Hazardous Substances Act.
(Signature and post-office address of person giving the guaranty or
undertaking)
(c) The application of a guaranty or undertaking referred to in
section 5(b)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes misbranded
within the meaning of the act.
Sec. 1500.213 Presentation of views under section 7 of the act.
(a) Presentation of views under section 7 of the act shall be
private and informal. The views presented shall be confined to matters
relevant to the contemplated proceeding. Such views may be presented by
letter or in person by the person to whom the notice was given, or by
his representative. In case such person holds a guaranty or undertaking
referred to in section 5(b)(2) of the act applicable to the article on
which such notice was based, such
[[Page 495]]
guaranty or undertaking, or a verified copy thereof, shall be made a
part of such presentation of views.
(b) Upon request, reasonably made, by the person to whom a notice
appointing a time and place for the presentation of views under section
7 of the act has been given, or by his representative, such time or
place, or both such time and place, may be changed if the request states
reasonable grounds therefor. Such request shall be addressed to the
office of the Consumer Product Safety Commission that issued the notice.
Sec. 1500.214 Examinations and investigations; samples.
When any officer or employee of the Commission collects a sample of
a hazardous substance for analysis under the act, the sample shall be
designated as an official sample if records or other evidence is
obtained by him or any other officer or employee of the Commission
indicating that the shipment or other lot of the article from which such
sample was collected was introduced or delivered for introduction into
interstate commerce, or was in or was received in interstate commerce,
or was manufactured within a Territory not organized with a legislative
body. Only samples so designated by an officer or employee of the
Commission shall be considered to be official samples:
(a) For the purpose of determining whether or not a sample is
collected for analysis, the term ``analysis'' includes examinations and
tests.
(b) The owner of a hazardous substance of which an official sample
is collected is the person who owns the shipment or other lot of the
article from which the sample is collected.
Sec. 1500.230 Guidance for lead (Pb) in consumer products.
(a) Summary. (1) The U.S. Consumer Product Safety Commission issues
this guidance to manufacturers, importers, distributors, and retailers
to protect children from hazardous exposure to lead in consumer
products.\1\ The Commission identifies the major factors that it
considers when evaluating products that contain lead, and informs the
public of its experience with products that have exposed children to
potentially hazardous amounts of lead.
---------------------------------------------------------------------------
\1\ This guidance is not a rule. It is intended to highlight certain
obligations under the Federal Hazardous Substances Act. Companies should
read that Act and the accompanying regulations in this part for more
detailed information.
---------------------------------------------------------------------------
(2) To reduce the risk of hazardous exposure to lead, the Commission
requests manufacturers to eliminate the use of lead that may be
accessible to children from products used in or around households,
schools, or in recreation. The Commission also recommends that, before
purchasing products for resale, importers, distributors, and retailers
obtain assurances from manufacturers that those products do not contain
lead that may be accessible to children.
(b) Hazard. Young children are most commonly exposed to lead in
consumer products from the direct mouthing of objects, or from handling
such objects and subsequent hand-to-mouth activity. The specific type
and frequency of behavior that a child exposed to a product will exhibit
depends on the age of the child and the characteristics and pattern of
use of the product. The adverse health effects of lead poisoning in
children are well-documented and may have long-lasting or permanent
consequences. These effects include neurological damage, delayed mental
and physical development, attention and learning deficiencies, and
hearing problems. Because lead accumulates in the body, even exposures
to small amounts of lead can contribute to the overall level of lead in
the blood and to the subsequent risk of adverse health effects.
Therefore, any unnecessary exposure of children to lead should be
avoided. The scientific community generally recognizes a level of 10
micrograms of lead per deciliter of blood as a threshold level of
concern with respect to lead poisoning. To avoid exceeding that level,
young children should not chronically ingest more than 15 micrograms of
lead per day from consumer products.
(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA),
15 U.S.C. 1261(f)(1), household products
[[Page 496]]
that expose children to hazardous quantities of lead under reasonably
foreseeable conditions of handling or use are ``hazardous substances.''
A household product that is not intended for children but which creates
such a risk of injury because it contains lead requires precautionary
labeling under the Act. 15 U.S.C. 1261(p). A toy or other article
intended for use by children which contains a hazardous amount of lead
that is accessible for children to ingest is a banned hazardous
substance. 15 U.S.C. 1261(q)(1)(B). In evaluating the potential hazard
associated with products that contain lead, the Commission staff
considers these major factors on a case-by-case basis: the total amount
of lead contained in a product, the bioavailability of the lead, the
accessibility of the lead to children, the age and foreseeable behavior
of the children exposed to the product, the foreseeable duration of the
exposure, and the marketing, patterns of use, and life cycle of the
product.
(2) Paint and similar surface coatings containing lead have
historically been the most commonly-recognized sources of lead poisoning
among the products within the Commission's jurisdiction. The Commission
has, by regulation, banned paint and other similar surface coatings that
contain more than 0.06% lead (``lead-containing paint''), toys and other
articles intended for use by children that bear lead-containing paint,
and furniture articles for consumer use that bear lead-containing paint.
16 CFR Part 1303. In recent years, however, the Commission staff has
identified a number of disparate products--some intended for use by
children and others simply used in or around the household or in
recreation--that presented a risk of lead poisoning from sources other
than paint. These products included vinyl miniblinds, crayons, figurines
used as game pieces, and children's jewelry.
(3) In several of these cases, the staff's determination that the
products presented a risk of lead poisoning resulted in recalls or in
the replacement of those products with substitutes, in addition to an
agreement to discontinue the use of lead in future production. The
Commission believes that, had the manufacturers of these lead-containing
products acted with prudence and foresight before introducing the
products into commerce, they would not have used lead at all. This in
turn would have eliminated both the risk to young children and the costs
and other consequences associated with the corrective actions.
(4) The Commission urges manufacturers to eliminate lead in consumer
products to avoid similar occurrences in the future. However, to avoid
the possibility of a Commission enforcement action, a manufacturer who
believes it necessary to use lead in a consumer product should perform
the requisite analysis before distribution to determine whether the
exposure to lead causes the product to be a ``hazardous substance.'' If
the product is a hazardous substance and is also a children's product,
it is banned. If it is a hazardous household substance but is not
intended for use by children, it requires precautionary labeling. This
same type of analysis also should be performed on materials substituted
for lead.
(5) The Commission also notes that, under the FHSA, any firm that
purchases a product for resale is responsible for determining whether
that product contains lead and, if so, whether it is a ``hazardous
substance.'' The Commission, therefore, recommends that, prior to the
acquisition or distribution of such products, importers, distributors,
and retailers obtain information and data, such as analyses of chemical
composition or accessibility, relevant to this determination from
manufacturers, or have such evaluations conducted themselves.
[63 FR 70649, Dec. 22, 1998]
Sec. 1500.231 Guidance for hazardous liquid chemicals in children's products.
(a) Summary. The U.S. Consumer Product Safety Commission issues this
guidance to manufacturers, importers, distributors, and retailers to
protect children from exposure to hazardous chemicals found in liquid-
filled children's products, such as rolling balls, bubble watches,
necklaces, pens, paperweights, keychains, liquid timers, and
[[Page 497]]
mazes.\1\ The Commission identifies the major factors that it considers
when evaluating liquid-filled children's products that contain hazardous
chemicals, and informs the public of its experience with exposure to
these hazardous chemicals to children. To reduce the risk of exposure to
hazardous chemicals, such as mercury, ethylene glycol, diethylene
glycol, methanol, methylene chloride, petroleum distillates, toluene,
xylene, and related chemicals, the Commission requests manufacturers to
eliminate the use of such chemicals in children's products. The
Commission also recommends that, before purchasing products for resale,
importers, distributors, and retailers obtain assurances from
manufacturers that liquid-filled children's products do not contain
hazardous liquid chemicals.
---------------------------------------------------------------------------
\1\ This guidance is not a rule. It is intended to highlight certain
obligations under the Federal Hazardous Substances Act. Companies should
read that Act and the accompanying regulations in this part for more
detailed information.
---------------------------------------------------------------------------
(b) Hazard. During reasonably foreseeable handling or use of liquid-
filled children's products, hazardous chemicals may become accessible to
young children in a manner that places children at risk. Young children
are exposed to the chemicals from directly mouthing them or from
handling such objects and subsequent hand-to-mouth or hand-to-eye
activity. The specific type and frequency of behavior that a child
exposed to a product will exhibit depends on the age of the child and
the characteristics and pattern of use of the product. The adverse
health effects of these chemicals to children include chemical poisoning
from ingestion of the chemicals, pneumonia from aspiration of the
chemicals into the lungs, and skin and eye irritation from exposure to
the chemicals. The chemicals may also be combustible.
(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA),
products that are toxic or irritants and that may cause substantial
injury or illness under reasonably foreseeable conditions of handling or
use, including reasonably foreseeable ingestion by children, are
``hazardous substances.'' 15 U.S.C. 1261(f)(1). A product that is not
intended for children, but that creates a risk of substantial injury or
illness because it contains hazardous chemicals, requires precautionary
labeling under the Act. 15 U.S.C. 1261(p). A toy or other article
intended for use by children that contains an accessible and harmful
amount of a hazardous chemical is banned. 15 U.S.C. 1261(q)(1)(A). In
evaluating the potential hazard associated with children's products that
contain hazardous chemicals, the Commission's staff considers certain
factors on a case-by-case basis, including: the total amount of the
hazardous chemical in a product, the accessibility of the hazardous
chemicals to children, the risk presented by that accessibility, the age
and foreseeable behavior of the children exposed to the product, and the
marketing, patterns of use, and life cycle of the product.
(2) The Commission's staff has identified a number of liquid-filled
children's products, such as rolling balls, bubble watches, necklaces,
pens, paperweights, maze toys, liquid timers, and keychains, that
contain hazardous chemicals. In several of these cases, the staff
determined that these products violated the FHSA because they presented
a risk of chemical poisoning and/or chemical pneumonia from aspiration.
This determination resulted in recalls or in the replacement of those
products with substitutes, as well as in agreements with the
manufacturers to discontinue the use of hazardous chemicals in liquid-
filled children's products in future production. The Commission believes
that these hazardous substances pose a risk to young children and,
consequently, manufacturers should not have included them in the product
design or manufacturing process.
(3) Therefore, the Commission considers the use of hazardous
chemicals in children's products such as those described above to be
ill-advised and encourages manufacturers to avoid using them in such
products. Further, the Commission recommends that, before purchasing
such products for resale, importers, distributors, and retailers obtain
assurances from the manufacturers that liquid-filled children's
[[Page 498]]
products do not contain hazardous liquid chemicals.
[63 FR 70648, Dec. 22, 1998]
Imports
Sec. 1500.265 Imports; definitions.
For the purposes of the regulations prescribed under section 14 of
the act:
(a) The term owner or consignee means the person who has the rights
of a consignee under the provisions of the Tariff Act of 1930 (secs.
483, 484, 485, 46 Stat. 721 as amended; 19 U.S.C. 1483, 1484, 1485).
(b) The term area office director means the director of the area
office of the Consumer Product Safety Commission having jurisdiction
over the port of entry through which a hazardous substance is imported
or offered for import, or such officer of the area office as he may
designate to act in his behalf in administering and enforcing the
provisions of section 14 of the act.
Sec. 1500.266 Notice of sampling.
When a sample of a hazardous substance offered for import has been
requested by the director of the area office, the collector of customs
having jurisdiction over the hazardous substance shall give to the owner
or consignee prompt notice of delivery of, or intention to deliver, such
sample. Upon receipt of the notice, the owner or consignee shall hold
such hazardous substance and not distribute it until further notice from
the area office director or the collector of customs of the results of
examination of the sample.
Sec. 1500.267 Payment for samples.
The Consumer Product Safety Commission will pay for all import
samples that are found to be in compliance with the requirements of the
act. Billing for reimbursement should be made by the owner or consignee
to the Commission area office headquarters in the territory of which the
shipment was offered for import. Payment for samples will not be made if
the hazardous substance is found to be in violation of the act, even
though subsequently brought into compliance under the terms of an
authorization to bring the article into compliance.
Sec. 1500.268 Hearing.
(a) If it appears that the hazardous substance may be subject to
refusal of admission, the area office director shall give the owner or
consignee a written notice to that effect, stating the reasons therefor.
The notice shall specify a place and a period of time during which the
owner or consignee shall have an opportunity to introduce testimony.
Upon timely request, giving reasonable grounds therefor, such time and
place may be changed. Such testimony shall be confined to matters
relevant to the admissibility of the hazardous substance, and may be
introduced orally or in writing.
(b) If such owner or consignee submits or indicates his intention to
submit an application for authorization to relabel or perform other
action to bring the hazardous substance into compliance with the act,
such testimony shall include evidence in support of such application. If
such application is not submitted at or prior to the hearing, the area
office director shall specify a time limit, reasonable in the light of
the circumstances, for filing such application.
Sec. 1500.269 Application for authorization.
Application for authorization to relabel or perform other action to
bring the hazardous substance into compliance with the act may be filed
only by the owner or consignee and shall:
(a) Contain detailed proposals for bringing the article into
compliance with the act.
(b) Specify the time and place where such operations will be carried
out and the approximate time for their completion.
Sec. 1500.270 Granting of authorization.
(a) When authorization contemplated by Sec. 1500.269 is granted, the
area office director shall notify the applicant in writing, specifying:
(1) The procedure to be followed:
(2) That the operations are to be carried out under the supervision
of an officer of the Consumer Product Safety Commission or the Bureau of
Customs, as the case may be;
[[Page 499]]
(3) A time limit, reasonable in the light of the circumstances, for
completion of the operations; and
(4) Such other conditions as are necessary to maintain adequate
supervision and control over the article.
(b) Upon receipt of a written request for extension of time to
complete such operations, containing reasonable grounds therefor, the
area office director may grant such additional time as he deems
necessary.
(c) An authorization may be amended upon a showing of reasonable
grounds therefor and the filing of an amended application for
authorization with the area office director.
(d) If ownership of a hazardous substance covered by an
authorization changes before the operations specified in the
authorization have been completed, the original owner will be held
responsible, unless the new owner has executed a bond and obtained a new
authorization. Any authorization granted under this section shall
supersede and nullify any previously granted authorization with respect
to the article.
Sec. 1500.271 Bonds.
(a) The bonds required under section 14(b) of the act may be
executed by the owner or consignee on the appropriate form of a customs
single-entry or term bond, containing a condition for the redelivery of
the merchandise or any part thereof upon demand of the collector of
customs and containing a provision for the performance of conditions as
may legally be imposed for the relabeling or other action necessary to
bring the hazardous substance into compliance with the act in such
manner as is prescribed for such bond in the customs regulations in
force on the date of request for authorization. The bond shall be filed
with the collector of customs.
(b) The collector of customs may cancel the liability for liquidated
damages incurred under the above-mentioned provisions of such a bond, if
he receives an application for relief therefrom, upon the payment of a
lesser amount or upon such other terms and conditions as shall be deemed
appropriate under the law and in view of the circumstances, but the
collector shall not act under this regulation in any case unless the
area office director is in full agreement with the action.
Sec. 1500.272 Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
The cost of supervising the relabeling or other action necessary in
connection with an import of a hazardous substance that fails to comply
with the act shall be paid by the owner or consignee who files an
application requesting such action and executes a bond, pursuant to
section 14(b) of the act. The cost of such supervision shall include,
but not be restricted to, the following:
(a) Travel expenses of the supervising officer.
(b) Per diem in lieu of subsistence of the supervising officer when
away from his home station as provided by law.
(c) Services of the supervising officer, to be calculated at the
rate of a GS 11, step 1 employee, except that such services performed by
a customs officer and subject to the provisions of the Act of February
13, 1911, as amended (sec. 5, 36 Stat. 901 as amended; 19 U.S.C. 267),
shall be calculated as provided in that Act.
(d) Services of the analyst, to be calculated at the rate of a GS
12, step 1 employee (which shall include the use of the chemical
laboratories and equipment of the Consumer Product Safety Commission).
(e) The minimum charge for services of supervising officers and of
analysts shall be not less than the charge for 1 hour, and time after
the first hour shall be computed in multiples of 1 hour, disregarding
fractional parts less than one-half hour.
[38 FR 27012, Sept. 27, 1973, as amended at 57 FR 28605, June 26, 1992]
PART 1501--METHOD FOR IDENTIFYING TOYS AND OTHER ARTICLES INTENDED FOR USE BY CHILDREN UNDER 3 YEARS OF AGE WHICH PRESENT CHOKING, ASPIRATION, OR INGESTION
HAZARDS BECAUSE OF SMALL PARTS--Table of Contents
Sec.
1501.1 Purpose.
[[Page 500]]
1501.2 Scope.
1501.3 Exemptions.
1501.4 Size requirements and test procedure.
1501.5 Enforcement procedure.
Authority: Secs. 2(f)(1)(D), (q)(1)(A), (s), 3(e)(1), and 10; 74
Stat. 372, 374, 375 as amended; 80 Stat. 1304-05, 83 Stat. 187-89 (15
U.S.C. 1261, 1262, 1269).
Source: 44 FR 34903, June 15, 1979, unless otherwise noted.
Sec. 1501.1 Purpose.
Section 1500.18(a)(9) of this chapter classifies as a banned
hazardous substance any toy or other article intended for use by
children under 3 years of age that presents a choking, aspiration, or
ingestion hazard because of small parts. This part 1501 describes
certain articles that are subject to Sec. 1500.18(a)(9); lists certain
articles that are specifically exempted; and provides a test method for
determining whether an article is hazardous to children under 3 because
it, or one of its components that can be detached or broken off during
normal or reasonable foreseeable use, is too small.
Sec. 1501.2 Scope.
(a) This regulation (Sec. 1500.18(a)(9) and the criteria described
in Sec. 1501.4 below) applies to all toys and other articles intended
for use by children under 3 years (36 months) of age that are introduced
into interstate commerce after the effective date. Such articles
include, but are not to limited to: squeeze toys; teethers; crib
exercisers; crib gyms; crib mobiles; other toys or articles intended to
be affixed to a crib, stroller, playpen, or baby carriage; pull and push
toys; pounding toys; blocks and stacking sets; bathtub, wading pool and
sand toys; rocking, spring, and stick horses and other figures; chime
and musical balls and carousels; jacks-in-the-box; stuffed, plush, and
flocked animals and other figures; preschool toys, games and puzzles
intended for use by children under 3; riding toys intended for use by
children under 3; infant and juvenile furniture articles which are
intended for use by children under 3 such as cribs, playpens, baby
bouncers and walkers, strollers and carriages; dolls which are intended
for use by children under 3 such as baby dolls, rag dolls, and bean bag
dolls; toy cars, trucks, and other vehicles intended for use by children
under 3. In addition, such articles include any other toys or articles
which are intended, marketed or labeled to be entrusted to or used by
children under 3 years of age.
(b) In determining which toys and other articles are intended for
use by children under 3 years (36 months) of age, for purposes of this
regulation, the following factors are relevant: the manufacturer's
stated intent (such as on a label) if it is a reasonable one; the
advertising, promotion, and marketing of the article; and whether the
article is commonly recognized as being intended for children under 3.
(c) This regulation does not apply to toys or articles which are
solely intended for use by children 3 years of age or older. In
addition, it does not apply to all articles to which children under 3
years of age might have access simply because of presence in a
household. Certain articles which are specifically exempted from this
regulation are listed in Sec. 1501.3 below.
Sec. 1501.3 Exemptions.
The following articles are exempt from this regulation
(Sec. Sec. 1500.18(a)(9) and 1501.4 below):
(a) Balloons;
(b) Books and other articles made of paper;
(c) Writing materials such as crayons, chalk, pencils, and pens;
(d) Children's clothing and accessories, such as shoe lace holders
and buttons;
(e) Grooming, feeding, and hygiene products, such as diaper pins and
clips, barrettes, toothbrushes, drinking glasses, dishes and eating
utensils;
(f) Phonograph records;
(g) Modeling clay and similar products;
(h) Fingerpaints, watercolors, and other paint sets;
(i) Rattles (as defined at 16 CFR 1510.2); and
(j) Pacifiers (as defined at 16 CFR 1511.2(a)).
Sec. 1501.4 Size requirements and test procedure.
(a) No toy or other children's article subject to Sec. 1500.18(a)(9)
and to this part
[[Page 501]]
1501 shall be small enough to fit entirely within a cylinder with the
dimensions shown in Figure 1, when tested in accordance with the
procedure in paragraph (b) of this section. In testing to ensure
compliance with this regulation, the dimensions of the Commission's test
cylinder will be no greater than those shown in Figure 1. (In addition,
for compliance purposes, the English dimensions shall be used. The
metric approximations are included only for convenience.)
(b)(1) Place the article, without compressing it, into the cylinder.
If the article fits entirely within the cylinder, in any orientation, it
fails to comply with the test procedure. (Test any detached components
of the article the same way.)
(2) If the article does not fit entirely within the cylinder,
subject it to the appropriate ``use and abuse'' tests of 16 CFR 1500.51
and 1500.52 (excluding the bite tests of Sec. Sec. 1500.51(c) and
1500.52(c)). Any components or pieces (excluding paper, fabric, yarn,
fuzz, elastic, and string) which have become detached from the article
as a result of the use and abuse testing shall be placed into the
cylinder, one at a time. If any such components or pieces fit entirely
within the cylinder, in any orientation and without being compressed,
the article fails to comply with the test procedure.
[[Page 502]]
[GRAPHIC] [TIFF OMITTED] TC03OC91.060
Sec. 1501.5 Enforcement procedure.
The Commission will enforce this regulation, unless it determines
that an emergency situation exists, only in accordance with Chapter 2,
Guide 2.05--Letter of Advice/Notices of Noncompliance of the CPSC
Enforcement Policy
[[Page 503]]
and Procedural Guides, issued in January 1990 and available from the
Office of the Secretary, Consumer Product Safety Commission, Washington,
DC 20207. Under the procedure described in this chapter, firms must be
informed by letter that they or their products may be the subject of
enforcement action and must be provided ten days within which to submit
evidence and arguments that the products are not violative or are not
covered by the regulation, prior to the initiation of enforcement action
by the Commission or by its delegated staff member. The function of
approving such enforcement actions is currently delegated by the
Commission to the Assistant Executive Director for Compliance and
Enforcement (copies of the existing delegation documents are also
available from the CPSC's Office of the Secretary).
[56 FR 46986, Sept. 17, 1991]
PART 1502--PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart A--General Provisions
Sec.
1502.1 Scope.
1502.2 Computation of time periods.
1502.3 Confidential information.
1502.4 Office of the Secretary.
Subpart B--Initiation of Proceedings
1502.5 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
1502.6 Filing objections and requests for a hearing on a regulation.
1502.7 Notice of filing of objections.
1502.8 Ruling on objections and requests for hearing.
1502.9 Modification or revocation of regulation or order.
1502.10 Denial of hearing in whole or in part.
1502.11 Judicial review after waiver of hearing on a regulation.
1502.12 Request for alternative form of hearing.
1502.13 Notice of hearing; stay of action.
1502.14 Effective date of a regulation when no objections are filed.
Subpart C--Appearance and Participation
1502.15 Appearance.
1502.16 Notice of participation.
1502.17 Advice on public participation in hearings.
Subpart D--Presiding Officer
1502.18 Presiding officer.
1502.19 Commencement of functions.
1502.20 Authority of presiding officer.
1502.21 Disqualification of presiding officer.
1502.22 Unavailability of presiding officer.
Subpart E--Hearing Procedures
1502.23 Filing and service of submissions.
1502.24 Petition to participate in forma pauperis.
1502.25 Disclosure of data and information to be relied on by the
participants.
1502.26 Purpose; oral and written testimony; burden of proof.
1502.27 Participation of nonparties.
1502.28 Conduct at oral hearings or conferences.
1502.29 Time and place of prehearing conference.
1502.30 Prehearing conference procedure.
1502.31 Summary decisions.
1502.32 Receipt of evidence.
1502.33 Official notice.
1502.34 Briefs and arguments.
1502.35 Interlocutory appeal from ruling of presiding officer.
1502.36 Official transcript.
1502.37 Motions.
Subpart F--Administrative Record
1502.38 Administrative record of a hearing.
1502.39 Examination of record.
Subpart G--Initial and Final Decision
1502.40 Initial decision.
1502.41 Appeal from or review of initial decision.
1502.42 Decision by Commission on appeal or review of initial decision.
1502.43 Reconsideration and stay of Commission's action.
Subpart H--Judicial Review
1502.44 Review by the courts.
1502.45 Copies of petitions for judicial review.
Authority: 15 U.S.C. 1261(q)(1)(B), 1262(a), 1262(e), 1269(a); 15
U.S.C. 1474(a); 21 U.S.C. 371(e)-(g).
Source: 56 FR 9278, Mar. 6, 1991, unless otherwise noted.
Subpart A--General Provisions
Sec. 1502.1 Scope.
The procedures in this part apply when--
[[Page 504]]
(a) A person has a right to an opportunity for a hearing under
sections 2(q)(1)(B) or 3(a) of the Federal Hazardous Substances Act
(``FHSA'') and 701(e) of the Federal Food, Drug, and Cosmetic Act
(``FDCA'') (15 U.S.C. 1261(q)(1)(B) and 1262(a), and 21 U.S.C. 371(e));
(b) The Commission elects to hold a hearing under section 3(e)(1) of
the FHSA or section 5 of the Poison Prevention Packaging Act (``PPPA'')
and section 701(e) of the FDCA (15 U.S.C. 1262(e)(1) and 1474(a), and 21
U.S.C. 371(e)); or
(c) The Commission concludes that it is in the public interest to
hold a formal evidentiary public hearing on any matter before it in such
a proceeding.
Sec. 1502.2 Computation of time periods.
Whenever a time period for taking action is specified by these
procedures, by the presiding officer, or by the Commission, Saturdays,
Sundays, and Federal holidays are included in computing time. However,
if the last day for taking such action falls on a Saturday, Sunday, or
Federal holiday, the action shall be timely if taken on or before the
next Federal Government business day.
Sec. 1502.3 Confidential information.
Whenever any participant desires or is required to submit
information in any proceeding under this part 1502, and the participant
believes that such information consists of trade secret or other
confidential business or financial information that should not be
disclosed publicly, the participant may, instead of submitting such
information, file a motion for a protective order containing a general
description of the information desired to be withheld, together with a
detailed argument supporting the claim that the information should be
held in confidence.
Sec. 1502.4 Office of the Secretary.
(a) The mailing address of the Commission's Office of the Secretary
is:
Office of the Secretary, Consumer Product Safety Commission, Washington,
DC 20207.
(b) The address for delivery to the Office of the Secretary is:
Office of the Secretary, Room 502, 4330 East West Highway, Bethesda,
Maryland 20816.
(c) The telephone number of the Office of the Secretary is (301)504-
0800.
[56 FR 9278, Mar. 6, 1991, as amended at 62 FR 46667, Sept. 4, 1997]
Subpart B--Initiation of Proceedings
Sec. 1502.5 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
(a) The Federal Register notice promulgating the final regulation
will describe how to submit objections and requests for hearing.
(b) On or before the 30th day after the date of publication of a
final regulation in the Federal Register, a person may file written
objections, with or without a request for a hearing, with the
Commission. The 30-day period may not be extended, except that
additional information supporting an objection may be received after 30
days upon a showing of inadvertent omission or for other good cause
shown, if consideration of the additional information will not delay
review of the objection and request for hearing.
Sec. 1502.6 Filing objections and requests for a hearing on a regulation.
(a) Objections and requests for a hearing under Sec. 1502.5(a) must
be filed with the Office of the Secretary and will be accepted for
filing if they meet the following conditions:
(1) They are submitted within the time specified in Sec. 1502.5(b).
(2) Each objection is separately numbered.
(3) Each objection specifies with particularity the provision(s) of
the regulation to which that objection is directed.
(4) Each objection on which a hearing is requested specifically
requests a hearing. Failure to request a hearing on an objection
constitutes a waiver of the right to a hearing on that objection.
(5) Each objection for which a hearing is requested includes a
detailed description of the basis for the objection and the factual
information or analysis in support thereof. Failure to include a
description and analysis for an objection constitutes a waiver of the
right
[[Page 505]]
to a hearing on that objection. The description and analysis may be used
only for the purpose of determining whether a hearing has been justified
under Sec. 1502.8, and do not limit the evidence that may be presented
if a hearing is granted.
(i) A copy of any report, article, survey, or other written document
relied upon must be submitted, unless the document is--
(A) A CPSC document that is routinely publicly available; or
(B) A recognized medical or scientific textbook or journal in the
public domain.
(ii) A summary of the non-documentary testimony to be presented by
any witnesses relied upon must be submitted.
(b) If an objection or request for a public hearing fails to meet
the requirements of this section the Office of the General Counsel shall
notify the Office of the Secretary of the deficiency. The Office of the
Secretary shall return it with a copy of the applicable regulations,
indicating those provisions not complied with. A deficient objection or
request for a hearing may be supplemented and subsequently filed if
submitted within the 30-day time period specified in Sec. 1502.5(b).
(c) If another person objects to a regulation issued in response to
a petition, the petitioner may submit a written reply to the Office of
the Secretary on or before the 15th day after the last day for filing
objections.
Sec. 1502.7 Notice of filing of objections.
As soon as practicable after the expiration of the time for filing
objections to and requests for hearing on agency action involving the
issuance, amendment, or revocation of a regulation under the FHSA or the
PPPA and section 701(e) of the Federal Food, Drug, and Cosmetic Act, the
Commission shall publish a notice in the Federal Register specifying
those parts of the regulation that have been stayed by the filing of
proper objections and, if no objections have been filed, stating that
fact. The notice does not constitute a determination that a hearing is
justified on any objections or requests for hearing that have been
filed. When to do so will cause no undue delay, the notice required by
this section may be combined with the notices described in
Sec. Sec. 1502.10 and 1502.13.
Sec. 1502.8 Ruling on objections and requests for hearing.
(a) As soon as practicable, the Commission will review all
objections and requests for hearing filed under Sec. 1502.6 and
determine--
(1) Whether the regulation should be modified or revoked under
Sec. 1502.9; and
(2) Whether a hearing has been justified.
(b) A request for a hearing will be granted if the material
submitted shows the following:
(1) There is a genuine and substantial issue of fact for resolution
at a hearing. A hearing will not be granted on issues of policy or law.
(2) The factual issue can be resolved by available and specifically
identified reliable evidence. A hearing will not be granted on the basis
of mere allegations or denials or general descriptions of positions and
contentions.
(3) The data and information submitted, if established at a hearing,
would be adequate to justify resolution of the factual issue in the way
sought by the person. A hearing will be denied if the Commission
concludes that the data and information submitted, even though accurate,
are insufficient to justify the factual determination urged.
(4) Resolution of the factual issue in the way sought by the person
is adequate to justify the action requested. A hearing will not be
granted on factual issues that are not determinative with respect to the
action requested, e.g., if the Commission concludes that the
Commission's action would be the same even if the factual issue were
resolved in the way sought, or if a request is made that a final
regulation include a provision not reasonably encompassed by the
proposal.
(5) The action requested is not inconsistent with any provision in
the FHSA or any regulation in 16 CFR subchapter C explaining or
particularizing the requirements of the FHSA.
(6) The requirements in other applicable regulations, and in the
notice promulgating the final regulation or
[[Page 506]]
the notice of opportunity for hearing are met.
(c) In making the determinations specified in paragraph (a) of this
section, the Commission may issue an appropriate order on the
determinations without further notice or opportunity for comment from
interested parties. However, the Commission, at its option, may use the
procedure specified in 16 CFR part 1052 or any other applicable public
procedure available to it.
(d) If it is uncertain whether a hearing has been justified under
the principles in paragraph (b) of this section, and the Commission
concludes that summary decision against the person requesting a hearing
should be considered, the Commission may serve upon the person by
registered mail a proposed order denying a hearing. The person has 30
days after receipt of the proposed order to demonstrate that the
submission justifies a hearing.
Sec. 1502.9 Modification or revocation of regulation or order.
If, upon review of an objection or request for hearing, the
Commission determines that the regulation should be modified or revoked,
the Commission will promptly take such action by notice in the Federal
Register. Further objections to or requests for hearing on the
modification or revocation may be submitted under Sec. Sec. 1502.5 and
1502.6, but no further issue may be taken with other provisions in the
regulation. Objections and requests for hearing that are not affected by
the modification or revocation will remain on file and be acted upon in
due course.
Sec. 1502.10 Denial of hearing in whole or in part.
(a) If the Commission determines upon review of the objections or
requests for hearing that a hearing is not justified, in whole or in
part, a notice of the determination will be published in the Federal
Register.
(b) The notice will state whether the hearing is denied in whole or
in part. If the hearing is denied in part, the notice will be combined
with the notice of hearing required by Sec. 1502.13, and will specify
the objections and requests for hearing that have been granted and
denied.
(c) Any denial will be explained. A denial based on an analysis of
the information submitted to justify a hearing will explain the
inadequacy of the information.
(d) The notice will confirm, modify, or stay the effective date of
the regulation involved.
(e) The record of the administrative proceeding relating to denial
in whole or in part of a public hearing on an objection or request for
hearing consists of the following:
(1) The entire rulemaking record;
(2) The objections and requests for hearing filed by the Office of
the Secretary; and
(3) The notice denying a formal evidentiary public hearing.
(f) The record specified in paragraph (e) of this section is the
exclusive record for the Commission's decision on the complete or
partial denial of a hearing. The record of the proceeding will be closed
as of the date of the Commission's decision denying a hearing, unless
another date is specified. A person who requested and was denied a
hearing may submit a petition for reconsideration or a petition for stay
of the Commission's action. A person who wishes to rely upon information
or views not included in the administrative record shall submit them to
the Commission with a petition to modify the final regulation.
(g) Denial of a request for a hearing in whole or in part is final
agency action reviewable in the courts, under the statutory provisions
governing the matter involved, as of the date of publication of the
denial in the Federal Register.
(1) Before requesting a court for a stay of the Commission's action
pending judicial review, a person shall first submit a petition to the
Commission for a stay of action.
(2) The time for filing a petition for judicial review of a denial
of a hearing on an objection or issue begins on the date the denial is
published in the Federal Register. The failure to file a petition for
judicial review within the period established in the statutory provision
governing the matter involved constitutes a waiver of the right to
judicial review of the objection or issue,
[[Page 507]]
regardless whether a hearing has been granted on other objections and
issues.
Sec. 1502.11 Judicial review after waiver of hearing on a regulation.
(a) A person with a right to submit objections and a request for
hearing under Sec. 1502.5(a) may submit objections and waive the right
to a hearing. The waiver may be either an explicit statement, or a
failure to request a hearing, as provided in Sec. 1502.6(a)(4).
(b) If a person waives the right to a hearing, the Commission will
rule upon the person's objections under Sec. Sec. 1502.8 through
1502.10. As a matter of discretion, the Commission may also order a
hearing on the matter.
(c) If the Commission rules adversely on a person's objection, the
person may petition for judicial review in a U.S. court of appeals under
the appropriate statute.
(1) The record for judicial review is the record designated in
Sec. 1502.10(e).
(2) The time for filing a petition for judicial review begins on the
date of publication of the Commission's ruling on the objections in the
Federal Register.
Sec. 1502.12 Request for alternative form of hearing.
(a) A person with a right to request a formal hearing may waive that
right and request a hearing before the Commission under 16 CFR part
1052.
(b) The request--
(1) May be on the person's own initiative or at the suggestion of
the Commission;
(2) Must be submitted by the person in the form of a petition before
publication of a notice of hearing under Sec. 1502.13 or a denial of
hearing under Sec. 1502.10; and
(3) Must be--
(i) In lieu of a request for a formal hearing under Sec. 1502.5; or,
(ii) If submitted with or after a request for formal hearing,
accompanied by a waiver of the right to a formal hearing, conditioned on
the request for the alternative form of hearing. Upon acceptance by the
Commission, the waiver becomes binding and may be withdrawn only by
waiving any right to any form of hearing, unless the Commission
determines otherwise.
(c) When more than one person requests and justifies a formal
hearing under these procedures, an alternative form of hearing may be
used only if all the persons concur and waive their right to request a
formal hearing.
(d) The Commission will determine whether an alternative form of
hearing should be used after considering the requests submitted and the
appropriateness of the alternative hearing for the issues raised in the
objections. The Commission's determination is binding unless, for good
cause, the Commission subsequently determines otherwise.
(e) If the Commission determines that an alternative form of hearing
will be used, the Commission will publish a notice in the Federal
Register setting forth the following information:
(1) A description of the regulation that is the subject of the
hearing.
(2) A statement specifying any part of the regulation that has been
stayed by operation of law or in the Commission's discretion.
(3) The time, date, and place of the hearing, or a statement that
such information will be contained in a later notice.
(4) The parties to the hearing.
(5) The issues at the hearing. The statement of issues determines
the scope of the hearing.
Sec. 1502.13 Notice of hearing; stay of action.
(a) If the Commission determines upon review of the objections and
requests for hearing that a hearing is justified on any issue, the
Commission will publish a notice setting forth the following:
(1) A description of the regulation that is the subject of the
hearing.
(2) A statement specifying any part of the regulation or order that
has been stayed by operation of law or in the Commission's discretion.
(3) The parties to the hearing.
(4) The issues of fact on which a hearing has been justified.
(5) A statement of any objections or requests for hearing for which
a hearing has not been justified, which are subject to Sec. 1502.10.
[[Page 508]]
(6) The presiding officer, or a statement that the presiding officer
will be designated in a later notice.
(7) The time within which notices of participation should be filed
under Sec. 1502.16.
(8) The date, time, and place of the prehearing conference, or a
statement that the date, time, and place will be announced in a later
notice. The prehearing conference may not commence until after the time
expires for filing the notice of participation required by
Sec. 1502.16(a).
(9) The time within which participants should submit written
information and views under Sec. 1502.25(b). Additional copies of
material already submitted under Sec. 1502.25 need not be included with
any later submissions.
(10) The contents of the portions of the administrative record
relevant to the issues at the hearing. Except for trade secrets or other
confidential information, the disclosure of which is prohibited by
statute, the portions listed will be placed on public display in the
Office of the Secretary before the notice is published.
(b) The statement of the issues determines the scope of the hearing
and the matters on which evidence may be introduced. The issues may be
revised by the presiding officer. A participant may obtain interlocutory
review by the Commission of a decision by the presiding officer to
revise the issues to include an issue on which the Commission has not
granted a hearing or to eliminate an issue on which a hearing has been
granted.
(c) A hearing is deemed to begin on the date of publication of the
notice of hearing.
Sec. 1502.14 Effective date of a regulation when no objections are filed.
(a) If no objections are filed and no hearing is requested on a
regulation under Sec. 1502.5, the regulation is effective on the date
specified in the regulation as promulgated.
(b) The Commission shall publish a confirmation of the effective
date of the regulation. The Federal Register document confirming the
effective date of the regulation may extend the time for compliance with
the regulation.
Subpart C--Appearance and Participation
Sec. 1502.15 Appearance.
(a) A person who has filed a notice of participation under
Sec. 1502.16 may appear in person or by counsel or other representative
in any hearing and, subject to Sec. 1502.27, may be heard concerning all
relevant issues.
(b) The presiding officer may strike a person's appearance for
violation of the requirements regarding conduct in Sec. 1502.28.
Sec. 1502.16 Notice of participation.
(a) Within 30 days after publication of the notice of hearing under
Sec. 1502.13, a person desiring to participate in a hearing is to file
with the Office of the Secretary a notice of participation in the
following form:
(Date)
Office of the Secretary, Consumer Product Safety Commission, Room
502, 4330 East West Highway, Bethesda, MD. Mailing address: Office of
the Secretary, Consumer Product Safety Commission, Washington, DC 20207.
Notice of Participation
(Title of Regulation)
Docket No.______________________________________________________________
Please enter the participation of:
(Name)__________________________________________________________________
(Street address)________________________________________________________
(City, State, and Zip Code)_____________________________________________
________________________________________________________________________
(Telephone number)______________________________________________________
Service on the above will be accepted by:
(Name)__________________________________________________________________
(City, State, and Zip Code)_____________________________________________
________________________________________________________________________
(Telephone number)______________________________________________________
The following statements are made as part of this notice of
participation:
A. Specific interests. (A statement of the specific interest of the
person in the proceeding, including the specific issues of fact
concerning which the person desires to be heard. This part need not be
completed by a party to the proceeding.)
B. Commitment to participate. (A statement that the person will
present documentary evidence or testimony at the hearing and will comply
with the requirements of Sec. 1502.25 of these procedures.)
(Signed)________________________________________________________________
(b) Any amendment to a notice of participation should be filed with
the Office of the Secretary and served on all participants.
[[Page 509]]
(c) No person may participate in a hearing who has not filed a
written notice of participation or whose participation has been stricken
under paragraph (e) of this section.
(d) The presiding officer may permit the late filing of a notice of
participation upon a showing of good cause.
(e) The presiding officer may strike the participation of a person
for nonparticipation in the hearing or for failure to comply with any
requirement of this subpart, e.g., disclosure of information as required
by Sec. 1502.25 or the prehearing order issued under Sec. 1502.30. Any
person whose participation is stricken may petition the Commission for
interlocutory review of that decision.
[56 FR 9278, Mar. 6, 1991, as amended at 62 FR 46667, Sept. 4, 1997]
Sec. 1502.17 Advice on public participation in hearings.
(a) All inquiries from the public about scheduling, location, and
general procedures should be addressed to the Office of the Secretary,
Consumer Product Safety Commission, Washington, DC 20207, or telephone
(301) 504-0800.
(b) Requests by hearing participants for changes in the schedule of
a hearing or for filing documents, briefs, or other pleadings should be
made in writing directly to the presiding officer.
(c) Under no circumstances will the Office of the General Counsel of
CPSC directly provide advice about a hearing to any person who is
participating or may participate in the hearing. In every hearing,
certain attorneys in the office are designated to represent the staff.
Other members of the office, ordinarily including the General Counsel,
are designated to advise the Commission on a final decision in the
matter. It is not compatible with these functions, nor would it be
professionally responsible, for the attorneys in the Office of the
General Counsel also to advise other participants in a hearing, or for
any attorney who may be called on to advise the Commission to respond to
inquiries from other participants in the hearing; such participants may
be urging views contrary to those of the staff involved or to what may
ultimately be the final conclusions of the Commission. Accordingly,
members of the Office of the General Counsel, other than the attorneys
responsible for representing the staff, will not answer questions about
the hearing from any participant or potential participant.
(d) Participants in a hearing may communicate with the attorneys
responsible for representing the staff, in the same way that they may
communicate with counsel for any other party in interest about the
presentation of matters at the hearing. It would be inappropriate to bar
discussion of such matters as stipulations of fact, joint presentation
of witnesses, or possible settlement of hearing issues. Members of the
public, including participants at hearings, are advised, however, that
all such communications, including those by telephone, will be recorded
in memoranda that can be filed with the Office of the Secretary.
(e) Separation of functions and ex parte communications will be
handled as follows.
(1) An interested person may meet or correspond with any CPSC
representative concerning a matter prior to publication of a notice
announcing a formal evidentiary public hearing on the matter. The
provisions of 16 CFR part 1012 apply to such meetings.
(2) Upon publication of a notice announcing a formal evidentiary
public hearing, the following rules concerning separation of functions
apply:
(i) The CPSC staff members responsible for preparing evidence and
participating in the hearing in the matter are, as a party to the
hearing, responsible for all investigative functions and for
presentation of the position of the staff at the hearing and in any
pleading or oral argument before the Commission. These representatives
of the staff may not participate or advise in any decision except as
witnesses or counsel in public proceedings. Except as provided herein,
there shall be no other communication between representatives of the
staff and representatives of the various Commissioners' offices
concerning the matter prior to the decision of the Commission. The
Commission may, however, designate other representatives of the staff to
advise the Commission. The designation will be in writing and filed with
the Office
[[Page 510]]
of the Secretary no later than the time specified in paragraph (f)(2) of
this section for the application of separation of functions. All
employees of the CPSC other than representatives of the involved staff
(except for those specifically designated otherwise) may be called upon
to advise and participate with the offices of the Commissioners in their
functions relating to the hearing and the final decision.
(ii) The General Counsel of CPSC shall designate members of the
Office of the General Counsel to advise and participate with the staff
in its functions in the hearing and shall designate other members of the
Office of the General Counsel to advise the offices of the Commissioners
in their functions related to the hearing and the final decision. The
members of the Office of the General Counsel designated to advise the
staff may not participate or advise in any decision of the Commission
except as counsel in public proceedings. The designation shall be in the
form of a memorandum filed with the Office of the Secretary and made a
part of the administrative record in the proceeding. There may be no
other communication between those members of the Office of the General
Counsel designated to advise the offices of the Commissioners and any
other person in the Office of the General Counsel or in the involved
staff with respect to the matter prior to the decision of the
Commission. The General Counsel may assign different attorneys to advise
either the staff or the offices of the Commissioners at any stage of the
proceedings. The General Counsel will ordinarily advise and participate
with the offices of the Commissioners in their functions relating to the
hearing and the final decision.
(iii) The Commissioners are responsible for the agency review and
final decision of the matter, with the advice and participation of
anyone in CPSC other than representatives of the responsible staff and
those members of the Office of the General Counsel designated to assist
in the staff functions in the hearing.
(iv) Between the date that separation of functions applies and the
date of the Commission's decision on the matter, communication
concerning the matter involved in the hearing will be restricted as
follows:
(A) No person outside CPSC may have an ex parte communication with
the presiding officer or any person representing the offices of the
Commissioners concerning the matter in the hearing. Neither the
presiding officer nor any person representing the offices of the
Commissioners may have any ex parte communications with a person outside
CPSC concerning the matter in the hearing. All communications are to be
public communications, as witness or counsel under the applicable
procedures.
(B) A participant in the hearing may submit a written communication
concerning a proposal for settlement to the presiding officer with a
request that it be transmitted to the Commission. These communications
are to be in the form of pleadings, served on all other participants,
and filed with the Office of the Secretary like any other pleading.
(C) A written communication contrary to this section must be
immediately served on all other participants and filed with the Office
of the Secretary by the presiding officer at the hearing, or by the
Commissioner, depending on who received the communication. An oral
communication contrary to this section must be immediately recorded in a
written memorandum and similarly served on all other participants and
filed with the Office of the Secretary. A person, including a
representative of a participant in the hearing, who is involved in an
oral communication contrary to this section, must, if possible, be made
available for cross-examination during the hearing with respect to the
substance of that conversation. Rebuttal testimony pertinent to a
written or oral communication contrary to this section will be
permitted. Cross-examination and rebuttal testimony will be transcribed
and filed with the Office of the Secretary.
(D) The making of a communication contrary to this section may,
consistent with the interests of justice and the policy of the
underlying statute,
[[Page 511]]
result in a decision adverse to the person knowingly making or causing
the making of such a communication.
[56 FR 9278, Mar. 6, 1991, as amended at 62 FR 46667, Sept. 4, 1997]
Subpart D--Presiding Officer
Sec. 1502.18 Presiding officer.
The presiding officer in a hearing will be an administrative law
judge qualified under 5 U.S.C. 3105.
Sec. 1502.19 Commencement of functions.
The functions of the presiding officer begin upon designation and
end upon the filing of the initial decision.
Sec. 1502.20 Authority of presiding officer.
The presiding officer has all powers necessary to conduct a fair,
expeditious, and orderly hearing, including the power to--
(a) Specify and change the date, time, and place of oral hearings
and conferences;
(b) Establish the procedures for use in developing evidentiary
facts, including the procedures in Sec. 1502.30(b) and to rule on the
need for oral testimony and cross-examination under Sec. 1502.26(b);
(c) Prepare statements of the areas of factual disagreement among
the participants;
(d) Hold conferences to settle, simplify, or determine the issues in
a hearing or to consider other matters that may expedite the hearing;
(e) Administer oaths and affirmations;
(f) Control the course of the hearing and the conduct of the
participants;
(g) Examine witnesses and strike or limit their testimony if they
fail to respond fully to proper questions;
(h) Admit, exclude, or limit evidence;
(i) Set the time for filing pleadings;
(j) Rule on motions and other procedural matters;
(k) Rule on motions for summary decision under Sec. 1502.31;
(l) Conduct the hearing in stages if the number of parties is large
or the issues are numerous and complex;
(m) Waive, suspend, or modify any procedure in this subpart if the
presiding officer determines that no party will be prejudiced, the ends
of justice will be served, and the action is in accordance with law;
(n) Strike the participation of any person under Sec. 1502.16(e) or
exclude any person from the hearing under Sec. 1502.28, or take other
reasonable disciplinary action; and
(o) Take any other action required for the fair, expeditious, and
orderly conduct of the hearing.
Sec. 1502.21 Disqualification of presiding officer.
(a) A participant may request the presiding officer to disqualify
himself/herself and withdraw from the proceeding. The ruling on any such
request may be appealed in accordance with Sec. 1502.35(b).
(b) A presiding officer who is aware of grounds for
disqualification, whether or not raised by a participant, shall withdraw
from the proceeding.
Sec. 1502.22 Unavailability of presiding officer.
(a) If the presiding officer is unable to act for any reason, the
Commission will assign the powers and duties to another presiding
officer. The substitution will not affect the hearing, except as the new
presiding officer may order.
(b) Any motion based on the substitution must be made within 10
days.
Subpart E--Hearing Procedures
Sec. 1502.23 Filing and service of submissions.
(a) Submissions, including pleadings in a hearing, are to be filed
with the Office of the Secretary. Two copies shall be filed. To
determine compliance with filing deadlines in a hearing, a submission is
considered filed on the day of filing with or mailing to the Office of
the Secretary. When this part allows a response to a submission and
prescribes a period of time for the filing of the response, an
additional 3 days are allowed for the filing of the response if the
submission is served by mail.
(b) The person making a submission shall serve copies of it on the
other participants.
(c) Service is accomplished by mailing a submission to the address
shown
[[Page 512]]
in the notice of participation or by personal delivery.
(d) All submissions are to be accompanied by a certificate of
service or by a statement that service is not required, stating the
reason therefor.
(e) No written submission or other portion of the administrative
record may be held in confidence, except as provided in Sec. 1502.3.
Sec. 1502.24 Petition to participate in forma pauperis.
(a) A participant who believes that compliance with the filing and
service requirements of this section constitutes an unreasonable
financial burden may submit to the Commission a petition to participate
in forma pauperis.
(b) The petition will be captioned: ``Request to Participate In
Forma Pauperis, Docket No. ------.'' Filing and service requirements for
the petition are described in paragraph (c) of this section, whether or
not the petition is granted; The petition must demonstrate that either:
(1) The participant is indigent and a strong public interest
justifies participation, or
(2) The participant's participation is in the public interest
because it can be considered of primary benefit to the general public.
(c) The Commission may grant or deny the petition. If the petition
is granted, the participant need file only one copy of each submission
with the Office of the Secretary. The Office of the Secretary will make
sufficient additional copies for the administrative record, and serve a
copy on each other participant.
Sec. 1502.25 Disclosure of data and information to be relied on by the participants.
(a) Before the notice of hearing is published under Sec. 1502.13,
the Assistant General Counsel for Regulatory Affairs shall submit the
following to the Office of the Secretary:
(1) The relevant portions of the administrative record of the
proceeding. Portions of the administrative record not relevant to the
issues in the hearing are not required to be submitted.
(2) All other documentary data and information relied upon.
(3) A narrative position statement on the factual issues in the
notice of hearing and the type of supporting evidence the Assistant
General Counsel intends to introduce.
(b) Within 60 days of the publication of the notice of hearing or,
if no participant will be prejudiced, within another period of time set
by the presiding officer, each participant shall submit to the Office of
the Secretary all data and information specified in paragraph (a) (2)
and (3) of this section and any objections that the administrative
record filed under paragraph (a)(1) of this section is incomplete, and
any documents in the participants' files containing factual information,
whether favorable or unfavorable to the regulation issued by the
Commission, which relates to the issues involved in the hearing.
(c) Submissions required by paragraphs (a) and (b) of this section
may be supplemented later in the proceeding, with the approval of the
presiding officer, upon a showing that the material in the supplement
was not reasonably known or available when the submission was made, that
the relevance of the material contained in the supplement could not
reasonably have been foreseen, or that admission of the material in the
supplement is necessary for a fair determination of the issues involved
in the hearing.
(d) A participant's failure to comply substantially and in good
faith with this section constitutes a waiver of the right to participate
further in the hearing; failure of a party to comply constitutes a
waiver of the right to a hearing.
(e) Participants may reference each other's submissions. To reduce
duplicative submissions, participants are encouraged to exchange and
consolidate lists of documentary evidence. If a particular document is
bulky or in limited supply and cannot reasonably be reproduced, and it
constitutes relevant evidence, the presiding officer may authorize
submission of a reduced number of copies.
(f) The presiding officer will rule on questions relating to this
section.
[[Page 513]]
Sec. 1502.26 Purpose; oral and written testimony; burden of proof.
(a) The objective of a formal evidentiary hearing is the fair
determination of relevant facts consistent with the right of all
interested persons to participate and the public interest in promptly
settling controversial matters affecting the public health and welfare.
(b) Accordingly, the evidence at a hearing is to be developed to the
maximum extent through written submissions, including written direct
testimony, which may be in narrative or in question-and-answer form.
(1) Direct testimony will be submitted in writing, except on a
showing that written direct testimony is insufficient for a full and
true disclosure of relevant facts and that the participant will be
prejudiced if unable to present oral direct testimony. If the proceeding
involves particular issues, each party may determine whether, and the
extent to which, each wishes to present direct testimony orally or in
writing.
(2) Oral cross-examination of witnesses will be permitted if it
appears that alternative means of developing the evidence are
insufficient for a full and true disclosure of the facts and that the
party requesting oral cross-examination will be prejudiced by denial of
the request or that oral cross-examination is the most effective and
efficient means to clarify the matters at issue.
(3) Witnesses shall give testimony under oath.
(c) A participant who proposes to substitute a new provision for a
provision objected to has the burden of proof in relation to the new
provision.
Sec. 1502.27 Participation of nonparties.
(a) A nonparty participant may--
(1) Attend all conferences (including the prehearing conference),
oral proceedings, and arguments;
(2) Submit written testimony and documentary evidence for inclusion
in the record;
(3) File written objections, briefs, and other pleadings; and
(4) Present oral argument.
(b) A nonparty participant may not--
(1) Submit written interrogatories; or
(2) Conduct cross-examination.
(c) A person whose petition is the subject of the hearing has the
same right as a party.
(d) A nonparty participant will be permitted additional rights if
the presiding officer concludes that the participant's interests would
not be adequately protected otherwise or that broader participation is
required for a full and true disclosure of the facts, but the rights of
a nonparty participant may not exceed the rights of a party.
Sec. 1502.28 Conduct at oral hearings or conferences.
All participants in a hearing will conduct themselves with dignity
and observe judicial standards of practice and ethics. They may not
indulge in personal attacks, unseemly wrangling, or intemperate
accusations or characterizations. Representatives of parties shall, to
the extent possible, restrain clients from improprieties in connection
with any proceeding. Disrespectful, disorderly, or contumacious language
or conduct, refusal to comply with directions, use of dilatory tactics,
or refusal to adhere to reasonable standards of orderly and ethical
conduct during any hearing shall constitute grounds for immediate
exclusion from the proceeding by the presiding officer.
Sec. 1502.29 Time and place of prehearing conference.
A prehearing conference will commence at the date, time, and place
announced in the notice of hearing, or in a later notice, or as
specified by the presiding officer in a notice modifying a prior notice.
At the prehearing conference, insofar as practicable at that time, the
presiding officer will establish the methods and procedures to be used
in developing the evidence, determine reasonable time periods for the
conduct of the hearing, and designate the times and places for the
production of witnesses for direct and cross-examination, if leave to
conduct oral examination is granted on any issue.
Sec. 1502.30 Prehearing conference procedure.
(a) Participants in a hearing are to appear at the prehearing
conference
[[Page 514]]
prepared to discuss and resolve all matters specified in paragraph (b)
of this section.
(1) To expedite the hearing, participants are encouraged to prepare
in advance for the prehearing conference. Participants should cooperate
with each other, and should request information and begin preparation of
testimony at the earliest possible time. Failure of a participant to
appear at the prehearing conference or to raise matters that reasonably
could be anticipated and resolved at that time will not delay the
progress of the hearing and constitutes a waiver of the rights of the
participant regarding such matters as objections to the agreements
reached, actions taken, or rulings issued by the presiding officer at or
as a result of the prehearing conference and may be grounds for striking
the participation under Sec. 1502.16.
(2) Participants shall bring to the prehearing conference the
following specific information, which will be filed with the Office of
the Secretary under Sec. 1502.23:
(i) Any additional information desired to supplement the submission
filed under Sec. 1502.25; the supplement may be filed if approved under
Sec. 1502.25.
(ii) A list of all witnesses whose testimony will be offered, orally
or in writing, at the hearing, with a full curriculum vitae for each.
Additional witnesses may be identified later, with the approval of the
presiding officer, on a showing that the witness was not reasonably
available at the time of the prehearing conference, that the relevance
of the witness's views could not reasonably have been foreseen at that
time, or for other good cause shown, as where a previously identified
witness is unforeseeably unable to testify.
(iii) All prior written statements, including articles and any
written statement signed or adopted, or a recording or transcription of
an oral statement made, by persons identified as witnesses if--
(A) The statement is available without making a request to the
witness;
(B) The statement relates to the subject matter of the witness's
testimony; and
(C) The statement either was made before the time the person agreed
to become a witness or has been made publicly available by the person.
(b) The presiding officer will conduct a prehearing conference for
the following purposes:
(1) To determine the areas of factual disagreement to be considered
at the hearing. The presiding officer may hold conferences off the
record in an effort to reach agreement on disputed factual questions,
subject to the ex parte limitations in Sec. 1502.17(f).
(2) To identify the most appropriate techniques for developing
evidence on issues in controversy and the manner and sequence in which
they will be used, including, where oral examination is to be conducted,
the sequence in which witnesses will be produced for, and the time and
place of, oral examination. The presiding officer may consider, but is
not limited to, the following techniques.
(i) Submission of narrative statements of position on factual issues
in controversy.
(ii) Submission of evidence or identification of previously
submitted evidence to support such statements, such as affidavits,
verified statements of fact, data, studies, and reports.
(iii) Exchange of written interrogatories directed to particular
witnesses.
(iv) Written requests for the production of additional
documentation, data, or other relevant information.
(v) Submission of written questions to be asked by the presiding
officer of a specific witness.
(vi) Identification of facts for which oral examination and/or
cross-examination is appropriate.
(3) To group participants with substantially like interests for
presenting evidence, making motions and objections, including motions
for summary decision, filing briefs, and presenting oral argument.
(4) To hear and rule on objections to admitting information
submitted under Sec. 1502.25 into evidence.
(5) To obtain stipulations and admissions of facts.
(6) To take other action that may expedite the hearing.
(c) The presiding officer shall issue, orally or in writing, a
prehearing order
[[Page 515]]
reciting the actions taken at the prehearing conference and setting
forth the schedule for the hearing. The order will control the
subsequent course of the hearing unless modified by the presiding
officer for good cause.
Sec. 1502.31 Summary decisions.
(a) After the hearing commences, a participant may move, with or
without supporting affidavits, for a summary decision on any issue in
the hearing. Any other participant may, within 10 days after service of
the motion, which time may be extended for an additional 10 days for
good cause, serve opposing affidavits or countermove for summary
decision. The presiding officer may set the matter for argument and call
for the submission of briefs.
(b) The presiding officer will grant the motion if the objections,
requests for hearing, other pleadings, affidavits, and other material
filed in connection with the hearing, or matters officially noticed,
show that there is no genuine issue as to any material fact and that a
participant is entitled to summary decision.
(c) Affidavits should set forth facts that would be admissible in
evidence and show affirmatively that the affiant is competent to testify
to the matters stated. When a properly supported motion for summary
decision is made, a participant opposing the motion may not rest upon
mere allegations or denials or general descriptions of positions and
contentions; affidavits or other responses must set forth specific facts
showing that there is a genuine issue of fact for the hearing.
(d) Should it appear from the affidavits of a participant opposing
the motion that for sound reasons stated, facts essential to justify the
opposition cannot be presented by affidavit, the presiding officer may
deny the motion for summary decision, allow additional time to permit
affidavits or additional evidence to be obtained, or issue other just
order.
(e) If on motion under this section a summary decision is not
rendered upon the whole case or for all the relief asked, and
evidentiary facts need to be developed, the presiding officer will issue
an order specifying the facts that appear without substantial
controversy and directing further evidentiary proceedings. The facts so
specified will be deemed established.
(f) A participant submitting or opposing a motion for summary
decision may obtain interlocutory review by the Commission of a summary
decision of the presiding officer.
Sec. 1502.32 Receipt of evidence.
(a) A hearing consists of the development of evidence and the
resolution of factual issues as set forth in this subpart and in the
prehearing order.
(b) All orders, transcripts, written statements of position, written
direct testimony, written interrogatories and responses, and any other
written material submitted in the proceeding comprise the administrative
record of the hearing, and will be promptly placed on public display in
the Office of the Secretary, except as ordered by the presiding officer.
(c) Written evidence, identified as such, is admissible unless a
participant objects and the presiding officer excludes it on objection
of a participant or on the presiding officer's own initiative.
(1) The presiding officer may exclude written evidence as
inadmissible only if--
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive;
(ii) Exclusion of part or all of the written evidence of a
participant is necessary to enforce the requirements of this subpart; or
(iii) The evidence was not submitted as required by Sec. 1502.25.
(2) Items of written evidence are to be submitted as separate
documents, sequentially numbered, except that a voluminous document may
be submitted in the form of a cross-reference to the documents filed
under Sec. 1502.25.
(3) Written evidence excluded by the presiding officer as
inadmissible remains a part of the administrative record, as an offer of
proof, for judicial review.
(d) Testimony, whether on direct or on cross-examination, is
admissible as evidence unless a participant objects and the presiding
officer excludes it.
(1) The presiding officer may exclude oral evidence as inadmissible
only if--
[[Page 516]]
(i) The evidence is irrelevant, immaterial, unreliable, or
repetitive; or
(ii) Exclusion of part or all of the evidence is necessary to
enforce the requirements of these procedures.
(2) If oral evidence is excluded as inadmissible, the participant
may take written exception to the ruling in a brief to the Commission,
without taking oral exception at the hearing. Upon review, the
Commission may reopen the hearing to permit the evidence to be admitted
if the Commission determines that its exclusion was erroneous and
prejudicial.
(e) The presiding officer may schedule conferences as needed to
monitor the progress of the hearing, narrow and simplify the issues, and
consider and rule on motions, requests, and other matters concerning the
development of the evidence.
(f) The presiding officer will conduct such proceedings as are
necessary for the taking of oral testimony, for the oral examination of
witnesses by the presiding officer on the basis of written questions
previously submitted by the parties, and for the conduct of cross-
examination of witnesses by the parties. The presiding officer shall
exclude irrelevant or repetitious written questions and limit oral
cross-examination to prevent irrelevant or repetitious examination.
(g) The presiding officer shall order the proceedings closed for the
taking of oral testimony relating only to trade secrets and privileged
or confidential commercial or financial information. Participation in
closed proceedings will be limited to the witness, the witness's
counsel, and Federal Government employees.
Sec. 1502.33 Official notice.
(a) Official notice may be taken of such matters as might be
judicially noticed by the courts of the United States or of any other
matter peculiarly within the general knowledge of CPSC as an expert
agency.
(b) If official notice is taken of a material fact not appearing in
the evidence of record, a participant, on timely request, will be
afforded an opportunity to show the contrary.
Sec. 1502.34 Briefs and arguments.
(a) Promptly after the taking of evidence is completed, the
presiding officer will announce a schedule for the filing of briefs.
Briefs are to be filed ordinarily within 45 days of the close of the
hearing. Briefs must include a statement of position on each issue, with
specific and complete citations to the evidence and points of law relied
on. Briefs must contain proposed findings of fact and conclusions of
law.
(b) The presiding officer may, as a matter of discretion, permit
oral argument after the briefs are filed.
(c) Briefs and oral argument shall refrain from disclosing specific
details of written and oral testimony and documents relating to trade
secrets and privileged or confidential commercial or financial
information, except as specifically authorized in a protective order
issued by the presiding officer.
Sec. 1502.35 Interlocutory appeal from ruling of presiding officer.
(a) Except as provided in paragraph (b) of this section and in
Sec. Sec. 1502.13(b), 1502.16(e), 1502.31(f), and 1502.37(d) authorizing
interlocutory appeals, rulings of the presiding officer may not be
appealed to the Commission before the Commission's consideration of the
entire record of the hearing.
(b) A ruling of the presiding officer is subject to interlocutory
appeal to the Commission if the presiding officer certifies on the
record or in writing that immediate review is necessary to prevent
exceptional delay, expense, or prejudice to any participant or
substantial harm to the public interest.
(c) When an interlocutory appeal is made to the Commission, a
participant may file a brief with the Commission only if such is
specifically authorized by the presiding officer or the Commission, and,
if such authorization is granted, within the period the Commission
directs. If a participant is authorized to file a brief, any other
participant may file a brief in opposition, within the period the
Commission directs. If no briefs are authorized, the appeal will be
presented as an oral argument to the Commission. The oral argument will
be transcribed. If briefs are authorized, oral argument will be
[[Page 517]]
heard only at the discretion of the Commission.
Sec. 1502.36 Official transcript.
(a) The presiding officer will arrange for a verbatim stenographic
transcript of oral testimony and for necessary copies of the transcript.
(b) One copy of the transcript will be placed on public display in
the Office of the Secretary upon receipt.
(c) Copies of the transcript may be obtained by application to the
official reporter and payment of costs thereof.
(d) Witnesses, participants, and counsel have 30 days from the time
the transcript becomes available to propose corrections in the
transcript of oral testimony. Corrections are permitted only for
transcription errors. The presiding officer shall promptly order
justified corrections.
Sec. 1502.37 Motions.
(a) Except for a motion made in the course of an oral hearing before
the presiding officer, a motion on any matter relating to the proceeding
shall be filed under Sec. 1502.23 and must include a draft order.
(b) A response may be filed within 10 days of service of a motion.
The time may be shortened or extended by the presiding officer for good
cause shown.
(c) The moving party has no right to reply, except as permitted by
the presiding officer.
(d) The presiding officer shall rule upon the motion and may certify
that ruling to the Commission for interlocutory review.
Subpart F--Administrative Record
Sec. 1502.38 Administrative record of a hearing.
(a) The record of a hearing consists of--
(1) The regulation or notice of opportunity for hearing that gave
rise to the hearing;
(2) All objections and requests for hearing filed with the Office of
the Secretary under Sec. Sec. 1502.5 and 1502.6;
(3) The notice of hearing published under Sec. 1502.13;
(4) All notices of participation filed under Sec. 1502.16;
(5) All Federal Register notices pertinent to the proceeding;
(6) All submissions filed under Sec. 1502.24, e.g., the submissions
required by Sec. 1502.25, all other documentary evidence and written
testimony, pleadings, statements of position, briefs, and other similar
documents;
(7) The transcript, written order, and all other documents relating
to the prehearing conference, prepared under Sec. 1502.30;
(8) All documents relating to any motion for summary decision under
Sec. 1502.31;
(9) All documents of which official notice is taken under
Sec. 1502.33;
(10) All pleadings filed under Sec. 1502.34;
(11) All documents relating to any interlocutory appeal under
Sec. 1502.35;
(12) All transcripts prepared under Sec. 1502.36; and
(13) Any other document relating to the hearing and filed with the
Office of the Secretary by the presiding officer or any participant.
(b) The record of the administrative proceeding is closed--
(1) With respect to the taking of evidence, when specified by the
presiding officer; and
(2) With respect to pleadings, at the time specified in
Sec. 1502.34(a) for the filing of briefs.
(c) The presiding officer may reopen the record to receive further
evidence at any time before the filing of the initial decision.
Sec. 1502.39 Examination of record.
Except as provided in Sec. 1502.3, documents in the record will be
publicly available. Documents available for examination or copying will
be placed on public display in the Office of the Secretary promptly upon
receipt in that office.
Subpart G--Initial and Final Decision
Sec. 1502.40 Initial decision.
(a) The presiding officer shall prepare and file an initial decision
as soon as practicable after the filing of briefs and oral argument.
(b) The initial decision shall contain--
[[Page 518]]
(1) Findings of fact based upon relevant, material, and reliable
evidence of record;
(2) Conclusions of law;
(3) A discussion of the reasons for the findings and conclusions,
including a discussion of the significant contentions made by any
participant;
(4) Citations to the record supporting the findings and conclusions;
(5) An appropriate regulation supported by substantial evidence of
record and based upon the findings of fact and conclusions of law
(unless the initial decision is to not issue a regulation);
(6) An effective date for the regulation (if any), together with an
explanation of why the effective date is appropriate; and
(7) The periods of time for filing exceptions to the initial
decision with the Office of the Secretary and for filing replies to such
exceptions, in accordance with Sec. 1502.41(a)-(c).
(c) The initial decision must refrain from disclosing specific
details of trade secrets and privileged or confidential commercial or
financial information, except as specifically authorized in a protective
order issued by the presiding officer.
(d) The initial decision is to be filed with the Office of the
Secretary and served upon all participants. Once the initial decision is
filed with the Office of the Secretary, the presiding officer has no
further jurisdiction over the matter, and any motions or requests filed
with the Office of the Secretary will be decided by the Commission.
(e) The initial decision becomes the final decision of the
Commission by operation of law unless a participant files exceptions
with the Office of the Secretary under Sec. 1502.41(a) or the Commission
files a notice of review under Sec. 1502.41(f).
(f) Notice that an initial decision has become the decision of the
Commission without appeal to or review by the Commission will be
published in the Federal Register. The Commission also may publish the
decision when it is of widespread interest.
Sec. 1502.41 Appeal from or review of initial decision.
(a) A participant may appeal an initial decision to the Commission
by filing exceptions with the Office of the Secretary, and serving them
on the other participants within the period specified in the initial
decision. The period for appeal to the Commission may not exceed 30
days, unless extended by the Commission under paragraph (d) of this
section.
(b) Exceptions must specifically identify alleged errors in the
findings of fact or conclusions of law in the initial decision, and
provide supporting citations to the record. Oral argument before the
Commission may be requested in the exceptions.
(c) Any reply to the exceptions shall be filed and served within the
period specified in the initial decision. The period may not exceed 30
days after the end of the period (including any extensions) for filing
exceptions, unless extended by the Commission under paragraph (d) of
this section.
(d) The Commission may extend the time for filing exceptions or
replies to exceptions for good cause shown.
(e) If the Commission decides to hear oral argument, the
participants will be informed of the date, time, and place of the
argument, the amount of time allotted to each participant, and the
issues to be addressed.
(f) Within 10 days following the expiration of the time for filing
exceptions (including any extensions), the Commission may file with the
Office of the Secretary, and serve on the participants, a notice of the
Commission's determination to review the initial decision. The
Commission may invite the participants to file briefs or present oral
argument on the matter. The time for filing briefs or presenting oral
argument will be specified in that or a later notice.
Sec. 1502.42 Decision by Commission on appeal or review of initial decision.
(a) On appeal from or review of the initial decision, the Commission
has all the powers given to the presiding officer with respect to the
initial decision. On the Commission's own initiative or on motion, the
Commission
[[Page 519]]
may remand the matter to the presiding officer for any further action
necessary for a proper decision.
(b) The scope of the issues at the public hearing is the same as the
scope of the issues on appeal at the public hearing unless the
Commission specifies otherwise.
(c) As soon as possible after the filing of briefs and the
presentation of any oral argument, the Commission will issue a final
decision in the proceeding, which meets the requirements established in
Sec. 1502.40 (b) and (c).
(d) The Commission may adopt the initial decision as the final
decision.
(e) Notice of the Commission's decision will be published in the
Federal Register. The Commission may also publish the decision when it
is of widespread interest.
Sec. 1502.43 Reconsideration and stay of Commission's action.
Following notice or publication of the final decision, a participant
may petition the Commission for reconsideration of any part or all of
the decision or may petition for a stay of the decision.
Subpart H--Judicial Review
Sec. 1502.44 Review by the courts.
(a) The Commission's final decision constitutes final agency action
from which a participant may petition for judicial review under the
statutes governing the matter involved. Before requesting an order from
a court for a stay of the Commission's action pending judicial review, a
participant shall first submit a petition for a stay of action under
Sec. 1502.43.
(b) Under 28 U.S.C. 2112(a), CPSC will request consolidation of all
petitions related to a particular matter.
Sec. 1502.45 Copies of petitions for judicial review.
The General Counsel of CPSC has been designated by the Commission as
the officer on whom copies of petitions for judicial review are to be
served. This officer is responsible for filing the record on which the
final decision is based. The record of the proceeding is certified by
the Secretary of the Commission.
PART 1505--REQUIREMENTS FOR ELECTRICALLY OPERATED TOYS OR OTHER ELECTRICALLY OPERATED ARTICLES INTENDED FOR USE BY CHILDREN--Table of Contents
Subpart A--Regulations
Sec.
1505.1 Definitions.
1505.2 Scope of part.
1505.3 Labeling.
1505.4 Manufacturing requirements.
1505.5 Electrical design and construction.
1505.6 Performance.
1505.7 Maximum acceptable surface temperatures.
1505.8 Maximum acceptable material temperatures.
Subpart B--Policies and Interpretations
1505.50 Stalled motor testing.
1505.51 Hot surfaces.
Authority: 15 U.S.C. 1261-1262, 2079.
Source: 38 FR 27032, Sept. 27, 1973, unless otherwise noted.
Subpart A--Regulations
Sec. 1505.1 Definitions.
(a) The following definitions apply to this part 1505:
(1) The term ``electrically operated toy or other electrically
operated article intended for use by children'' means any toy, game, or
other article designed, labeled, advertised, or otherwise intended for
use by children which is intended to be powered by electrical current
from nominal 120 volt (110-125 v.) branch circuits. Such articles are
referred to in this part in various contexts as ``toy'' or
``electrically operated toy.'' If the package (including packing
materials) of the toy or other article is intended to be used with the
product, it is considered to be part of the toy or other article. This
definition does not include components which are powered by circuits of
30 volts r.m.s. (42.4 volts peak) or less, articles designed primarily
for use by adults which may be used incidentally by children, or video
games.
(2) The term video games means video game hardware systems, which
are games that both produce a dynamic video image, either on a viewing
screen that is part of the video game or,
[[Page 520]]
through connecting cables, on a television set, and have some way to
control the movement of at least some portion of the video image.
[38 FR 27032, Sept. 27, 1973, as amended at 58 FR 40335, July 28, 1993]
Sec. 1505.2 Scope of part.
This part sets forth the requirements whereby electrically operated
toys and other electrically operated articles intended for use by
children (as defined in Sec. 1505.1(a)(1)) are not banned toys or banned
articles under Sec. 1500.18(b)(1) of this chapter.
Sec. 1505.3 Labeling.
(a) General. Electrically operated toys, and the instruction sheets
and outer packaging thereof, shall be labeled in accordance with the
requirements of this section and any other applicable requirements of
the Federal Hazardous Substances Act and regulations promulgated
thereunder. All labeling shall be prominently and conspicuously
displayed under customary conditions of purchase, storage, and use. All
required information shall be readily visible, noticeable, clear, and,
except where coding is permitted, shall be in legible English (other
languages may also be included as appropriate). Such factors governing
labeling as location, type size, and contrast against background may be
based on necessary condensations to provide a reasonable display.
(b) Specific items. (1) The toy shall be marked in accordance with
the provisions of paragraph (d) of this section to indicate:
(i) The electrical ratings required by paragraph (c) of this
section.
(ii) Any precautionary statements required by paragraph (e) of this
section.
(iii) The date (month and year) of manufacture (or appropriate
codes). As an alternative to putting this information on the toy itself,
it may be included in the instructions provided with the toy (see
paragraph (b)(3) of this section).
(2) The shelf pack or package of the toy shall be labeled in
accordance with the provisions of paragraph (d) of this section to
indicate:
(i) The date (month and year) of manufacture (or appropriate codes).
(ii) The electrical ratings required by paragraph (c) of this
section.
(iii) Any precautionary statements required by paragraph (e) of this
section.
(3) Each toy shall be provided with adequate instructions that are
easily understood by children of those ages for which the toy is
intended. The instructions shall describe the applicable installation,
assembly, use, cleaning, maintenance (including lubrication), and other
functions as appropriate. Applicable precautions shall be included as
well as the information required by paragraphs (b) (1) and (2) of this
section, except that the date of manufacture information described in
paragraph (b)(1)(iii) of this section need not be included in the
instructions provided with the toy if it is placed on the toy itself.
The instructions shall also contain a statement addressed to parents
recommending that the toy be periodically examined for potential hazards
and that any potentially hazardous parts be repaired or replaced.
(4) If a toy is produced or assembled at more than one
establishment, the toy and its shelf pack or package shall have a
distinctive mark (which may be in code) identifying the toy as the
product of a particular establishment.
(c) Rating. (1) A toy shall be marked to indicate its rating in
volts and also in amperes and/or watts.
(2) If a toy utilizes a single motor as its only electric energy
consuming component, the electrical rating may be marked on a motor
nameplate and need not be marked elsewhere on the toy if the nameplate
is readily visible after the motor has been installed in the toy.
(3) A toy shall be rated for alternating current only, direct
current only, or both alternating and direct current.
(4) The alternating current rating shall include the frequency or
frequency range requirement, if necessary because of a special
component.
(d) Markings. (1) The markings required on the toy by paragraph (b)
of this section shall be of a permanent nature, such as paint-stenciled,
die-stamped, molded, or indelibly stamped. The markings shall not be
permanently obliterable by spillage of any material
[[Page 521]]
intended for use with the toy and shall not be readily removable by
cleaning with ordinary household cleaning substances. All markings on
the toy and labeling of the shelf pack or package required by paragraph
(b) of this section shall contrast sharply with the background (whether
by color, projection, or indentation) and shall be readily visible and
legible. Such markings and labeling shall appear in lettering of a
height not less than that specified in paragraph (d)(2) of this section,
except that those words shown in capital letters in paragraph (e) of
this section shall appear in capital lettering of a height not less than
twice that specified in paragraph (d)(2) of this section.
(2) Minimum lettering heights shall be as follows:
Surface Area Display Marking, Minimum Height of Lettering
------------------------------------------------------------------------
Square inches Inches
------------------------------------------------------------------------
Under 5...................................................... \1/16\
5 or more and under 25....................................... \1/8\
25 or more and under 100..................................... \3/16\
100 or more and under 400.................................... \1/4\
400 or more.................................................. \1/2\
------------------------------------------------------------------------
(e) Precautionary statements--(1) General. Electrically operated
toys shall bear the statement: ``CAUTION--ELECTRIC TOY.'' The
instruction booklet or sheet accompanying such toys shall bear on the
front page thereof (in the type size specified in Sec. 1500.121), as a
preface to any written matter contained therein, and the shelf pack or
package of such toys shall bear in the upper right hand quarter of the
principal display panel, the statement: ``CAUTION--ELECTRIC TOY: Not
recommended for children under ---- years of age. As with all electric
products, precautions should be observed during handling and use to
prevent electric shock.'' The blank in the preceding statement shall be
filled in by the manufacturer, but in no instance shall the manufacturer
indicate that the article is recommended for children under 8 years of
age if it contains a heating element. In the case of other electrically
operated products which may not be considered to be ``toys'' but are
intended for use by children, the term ``ELECTRICALLY OPERATED PRODUCT''
may be substituted for the term ``ELECTRIC TOY.''
(2) Thermal hazards. (i) Toys having Type C or Type D surfaces
(described in Sec. 1505.6(g)(2)) which reach temperatures greater than
those shown in paragraph (e)(2)(ii) of this section shall be defined as
hot and shall be marked where readily noticeable when the hot surface is
in view with the statement: ``HOT--Do Not Touch.'' When the marking is
on other than the hot surface, the word ``HOT'' shall be followed by
appropriate descriptive words such as ``Molten Material,'' ``Sole
Plate,'' or ``Heating Element,'' and the statement ``Do Not Touch.'' An
alternative statement for a surface intended to be handheld as a
functional part of the toy shall be ``HOT -------- Handle Carefully,''
the blank being filled in by the manufacturer with a description of the
potential hazard such as ``Curler'' or ``Cooking Surface.''
(ii) Surfaces requiring precautionary statements of thermal hazards
are those exceeding the following temperatures when measured by the test
described in Sec. 1505.6(g)(4):
------------------------------------------------------------------------
Thermal Temperature
Surface type (see Sec. 1505.6 inertia -------------------------
(g)(2)) type \1\ Degrees C. Degrees F.
------------------------------------------------------------------------
C................................ 1 65 149
C................................ 2 75 167
C................................ 3 85 185
C................................ 4 95 203
D................................ 1 55 131
D................................ 2 70 158
D................................ 3 80 176
D................................ 4 90 194
------------------------------------------------------------------------
\1\ Thermal inertia types are defined in terms of lambda as follows:
Type 1: Greater than 0.0045 (e.g., most metals).
Type 2: More than 0.0005 but not more than 0.0045 (e.g., glass).
Type 3: More than 0.0001 but not more than 0.0005 (e.g., most plastics).
Type 4: 0.0001 or less (e.g., future polymeric materials).
The thermal inertia of a material can be obtained by multiplying the
thermal conductivity (cal./em./sec./degrees C.) by the density (gm./
cm.\3\) by the specific heat (cal./gm./degrees C.)
(3) Lamp hazards--(i) Replaceable incandescent lamps. A toy with one
or more replaceable incandescent lamps, having a potential difference of
more than 30 volts r.m.s. (42.4 volts peak) between any of its
electrodes or lampholder contacts and any other part or ground, shall be
marked inside the lamp compartment where readily noticeable during lamp
replacement with the statement: ``WARNING--Do not
[[Page 522]]
use light bulbs larger than ---- watts'', the blank being filled in by
the manufacturer with a number specifying the wattage rating of the
lamp. Such toys shall bear the statement: ``WARNING--Shock Hazard. Pull
plug before changing light bulb'' on the outside of the lamp compartment
where it will be readily noticed before gaining access to the lamp
compartment.
(ii) Nonreplacement incandescent lamps. A toy which utilizes one or
more nonreplaceable incandescent lamps (other than pilot or indicator
lamps) shall be marked where clearly visible with the statement:
``SEALED UNIT--Do not attempt to change light bulb'' or equivalent.
(4) Water. If not suitable for immersion in water, a toy cooking
appliance (such as a corn popper, skillet, or candy-maker) or other
article which may conceivably be immersed in water shall be marked with
the statement: ``DANGER--To prevent electric shock, do not immerse in
water; wipe clean with damp cloth'' or equivalent.
[38 FR 27032, Sept. 27, 1973, as amended at 42 FR 34280, July 5, 1977;
42 FR 43392, Aug. 29, 1977]
Sec. 1505.4 Manufacturing requirements.
(a) General. (1) Only materials safe and suitable for the particular
use for which the electrically operated toy is intended shall be
employed.
(2) Toys shall be produced in accordance with detailed material
specifications, production specifications, and quality assurance
programs. Quality assurance programs shall be established and maintained
by each manufacturer to assure compliance with all requirements of this
part.
(3) The manufacturer or importer shall keep and maintain for 3 years
after production or importation of each lot of toys (i) the material and
production specifications and the description of the quality assurance
program required by paragraph (a)(2) of this section, (ii) the results
of all inspections and tests conducted, and (iii) records of sale and
distribution. These records shall be made available upon request at
reasonable times to any officer or employee of the Consumer Product
Safety Commission. The manufacturer or importer shall permit such
officer or employee to inspect and copy such records, to make such
inventories of stock as he deems necessary, and to otherwise verify the
accuracy of such records.
(4) Toys shall be constructed and finished with a high degree of
uniformity and as fine a grade of workmanship as is practicable in a
well-equipped manufacturing establishment. Each component of a toy shall
comply with the requirements set forth in this part.
(b) [Reserved]
(c) Protective coatings. Iron and steel parts shall be suitably
protected against corrosion if the lack of a protective coating would
likely produce a hazardous condition in normal use or when the toy is
subjected to reasonably foreseeable damage or abuse.
(d) Mechanical assembly--(1) General. A toy shall be designed and
constructed to have the strength and rigidity necessary to withstand
reasonably foreseeable damage and abuse without producing or increasing
a shock, fire, or other accident hazard. An increase in hazards may be
due to total or partial structural collapse of the toy resulting in a
reduction of critical spacings, loosening or displacement of one or more
components, or other serious defects.
(2) Mounting. Each switch, lampholder, motor, automatic control,
transformer, and similar component shall be securely mounted and shall
be prevented from turning, unless the turning of such component is part
of the design of the toy and produces no additional hazard such as
reduced spacings below acceptable levels or stress on the connection.
Friction between tight-fitting surfaces shall not be considered
sufficient for preventing the turning of components. The proper use of a
suitable lockwasher or a keyed and notched insert plus a suitable
lockwasher for single-hole mountings shall be acceptable. Each toy shall
be designed and constructed so that vibrations occurring during normal
operation and after reasonably foreseeable damage or abuse will not
affect it adversely. Brush caps shall be tightly threaded or otherwise
designed to prevent loosening.
[[Page 523]]
(3) Structural integrity. Heating elements shall be supported in a
substantial and reliable manner and shall be structurally prevented from
making contacts inside or outside of the toy which may produce shock
hazards. The current-carrying component(s) of the heating element shall
be enclosed, and the enclosure shall be designed or insulated to prevent
the development of a shock or fire hazard that may result from element
failure. A toy operating with a gas or liquid under pressure, such as an
electrically operated steam engine, shall be tested with respect to its
explosion hazard and shall be provided with a pressure relief device
that will discharge in the safest possible direction; that is, avoiding
direct human contact and avoiding the wetting of electrical contacts.
(e) Insulating material. (1) Material to be used for mounting
uninsulated live electrical elements shall be generally accepted as
suitable for the specific application, particularly with regard to
electrical insulation (voltage breakdown) and good aging characteristics
(no significant change in insulating characteristics over the expected
lifetime of the toy).
(2) Material used to insulate a heating element from neighboring
parts shall be suitable for the purpose. If plain asbestos in a glass
braid is used to so insulate the heating element, it shall be tightly
packed and totally enclosed by the braid, and the overall thickness,
including the braid, shall not be less than one-sixteenth inch. Hard
fiber may be used for electrically insulating bushings, washers,
separators, and barriers, but is not sufficient as the sole support of
uninsulated live metal parts.
(f) Enclosures--(1) General. Each toy shall have an enclosure
constructed of protective material suitable for the particular
application, for the express purpose of housing all electrical parts
that may present a fire, shock, or other accident hazard under any
conditions of normal use or reasonably foreseeable damage or abuse.
Enclosures shall meet the performance requirements prescribed by
Sec. 1505.6(b).
(2) Accessibility. An enclosure containing a wire, splice, brush
cap, connection, electrical component, or uninsulated live part or parts
at a potential of more than 30 volts r.m.s. (42.4 volts peak) to any
other part or to ground:
(i) Shall be sealed by welding, riveting, adhesive bonding, and/or
by special screws or other fasteners not removable with a common
household tool (screwdriver, pliers, or other similar household tool)
used as intended; and
(ii) Shall have no opening permitting entry of a 0.010-inch-diameter
music wire that could contact a live part. Cross-notch-head screws,
spring clips, bent tabs, and similar fasteners shall not be considered
suitable sealing devices for enclosures since they are easy to remove
with common household tools. Bent tabs shall be acceptable if, due to
metal thickness or other factors, they successfully resist forceful
attempts to dislodge them with ordinary tools.
(3) Nonapplication. The requirements of this paragraph are not
applicable to an insulating husk enclosure or equivalent that covers the
electrodes of a replaceable incandescent lamp and its lampholder
contacts. The primary function of an enclosure containing a lamp shall
be to protect it from breakage during normal use or reasonably
foreseeable damage or abuse.
(g) Spacings. The distance, through air or across the surface of an
insulator, between uninsulated live metal parts and a metallic enclosure
and between uninsulated live metal parts and all other metal parts shall
be suitable for the specific application as determined by the dielectric
strength requirements prescribed by Sec. 1505.6(e)(2). Electrical
insulating linings on barriers shall be held securely in place.
(h) Special safety features--(1) Moving parts. If the normal use of
a toy involves accident hazards, suitable protection shall be provided
for the reduction of such hazards to an acceptable minimum. For example,
rotors, pulleys, belting, gearing, and other moving parts shall be
enclosed or guarded to prevent accidental contact during normal use or
when subjected to reasonably foreseeable damage or abuse. Such enclosure
or guard shall not contain openings that permit entrance of a \1/4\-
inch-diameter rod and present a hazardous condition.
[[Page 524]]
(2) Switch marking. Any toy having one or more moving parts which
perform an inherent function of the toy and which may cause personal
injury shall have a switch that can deenergize the toy by a simple
movement to a plainly marked ``OFF'' position. Momentary contact
switches which are normally in the ``OFF'' position need not be so
marked.
(3) Electrically operated sewing machines. Electrically operated toy
sewing machines shall be designed and constructed to eliminate the
possibility of a child's finger(s) being pierced by a needle. For the
purpose of this paragraph, a clearance of not more than five thirty-
seconds of an inch below the point of the needle when in its uppermost
position or below the presser foot, if provided, shall be considered
satisfactory.
(4) Pressure relief valves. A pressurized enclosure shall have an
automatic pressure relief device and shall be capable of withstanding
hydrostatic pressure equal to at least five times the relief pressure.
(5) Containers for heated materials. Containers intended for holding
molten compounds and hot liquids shall be designed and constructed to
minimize accidental spillage. A pot or pan having a lip and one or more
properly located pouring spouts and an adequately thermally insulated
handle may provide satisfactory protection. Containers intended solely
for baking need not be designed and constructed to minimize accidental
spillage. Containers shall be of such material and construction t+at
they will not deform or melt when subjected to the maximum operating
temperature occurring during normal use or after reasonably foreseeable
damage or abuse.
(6) Water. Electrically operated toys (such as toy irons) shall not
be designed or manufactured to be used with water except for toy steam
engines or other devices in which the electrical components are separate
from the water reservoir and are completely contained in a sealed
chamber. Toys requiring occasional or repeated cleaning with a wet cloth
shall be constructed to prevent seepage of water into any electrically
active area that may produce a hazardous condition.
Sec. 1505.5 Electrical design and construction.
(a) Switches. (1) Switches and other control devices of electrically
operated toys shall be suitable for the application and shall have a
rating not less than that of the load they control (see
Sec. 1505.6(e)(5)(ii) regarding electrical switch overload). A switch
that controls a replaceable incandescent lamp, electrode, or lampholder
contact which is at a potential of more than 30 volts r.m.s. (42.4 volts
peak) to any other part or to ground shall open both sides of the
circuit and shall have a marked ``OFF'' position. A switch that may
reasonably be expected to be subjected to temperatures higher than 50
deg.C. (122 deg.F.) shall be constructed of materials which are
suitable for use at such temperatures.
(2) Switches shall be located and protected so that they are not
subject to mechanical damage that would produce a hazard in normal use
or from reasonably foreseeable damage or abuse (see Sec. 1505.6(b)).
(b) Lamps. (1) A replaceable incandescent lamp having a voltage of
more than 30 volts r.m.s. (42.4 volts peak) between any of its
electrodes or lampholder contacts and any other part or ground shall be
in an enclosure that has at least one door or cover permitting access to
the lamp. Such door(s) or cover(s) of the enclosure shall be so designed
and constructed that they cannot be opened manually or with a flat
bladed screwdriver or pliers.
(2) With all access doors and covers closed, the lamp enclosure
shall have no opening that will permit entry of a straight rod 6 inches
long and one-fourth inch in diameter if such entry would present an
electrical hazard. The lamp shall be located no less than one-half inch
from any \1/4\-inch-diameter opening in the enclosure.
(3) A toy having one or more lampholders shall be designed and
constructed so that no live parts other than the contacts of the
lampholders are exposed to contact by persons removing or replacing
lamps. The shells of all lampholders for incandescent lamps shall be at
the same potential.
(4) If the potential between the contacts of a lampholder for a
replaceable
[[Page 525]]
incandescent lamp and any other part or ground is greater than 30 volts
r.m.s. (42.4 volts peak), the contacts shall be located in an insulating
husk or equivalent.
(c) Transformers. Transformers that are integral parts of toys shall
be of the 2-coil insulated type.
(d) Automatic controls. Automatic controls for temperature
regulations shall have the necessary capacity and reliability for their
particular application.
(e) Power supply connections (cords and plugs). (1) A toy shall be
provided with a suitable means for attachement to the power supply
circuit.
(2) A toy requiring a power cord shall have a flexible cord that is
permanently attached to the toy.
(3) The perimeter of the face of the attachment-plug cap shall be
not less than five-sixteenths of an inch from any point on either blade
of the plug.
(4) The body of the attachment-plug cap shall decrease in cross
section from the face but shall have an expansion of the body, after a
suitable distance from the face, sufficient to provide an effective
finger grip.
(5) A flexible electrical power cord provided on a toy shall be type
SP-2 (as defined in the ``National Electrical Code,'' Chapter 4, article
400, pages 230-241 (1978) \1\, or its equivalent, or a heavier general-
use type, and shall be not less than 5 feet nor more than 10 feet in
length when measured as the overall length of the attached cord outside
the enclosure of the toy, including fittings, up to the face of the
attachment-plug cap. However, hand-held educational or hobby-type
products intended for heating such as woodburning tools, shall use one
of the type cords designated below, in accordance with the weight of the
product without the cord:
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\1\ NFPA No. 70-1978, 1978 edition of National Electrical Code,
Article 400, ``Flexible Cords and Cables,'' pages 70-230 through 70-240,
published by the National Fire Protection Association, which is
incorporated by reference. Copies of this document are available from
the National Fire Protection Administration, 60 Batterymarch Park,
Quincy, Massachusetts 02269. This document is also available for
inspection at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC. This incorporation by reference
was approved by the Director of the Federal Register. These materials
are incorporated as they exist in the edition which has been approved by
the Director of the Federal Register and which has been filed with the
Office of the Federal Register.
---------------------------------------------------------------------------
Weight of appliance (without cord) and cord type
\1/2\ lb. (0.227 kg) and lighter: SP-1, SPT-1, HPD. Heavier than \1/
2\ lb. (0.227 kg): SP-2, SPT-2, SV, SVO, SVT, SVTO, HPD, HPN, SJ, SJO,
SJT, SJTO.
(6) A flexible cord and plug shall have a current-carrying capacity
of not less than the ampere rating of the toy, and the conductor of the
cord shall have a cross sectional area no less than No. 18 AWG (American
wire gauge).
(7) Cords on toys which are intended to come in direct contact with
water or other liquids during use shall be of a jacketed type. Cords on
toys with which water or other liquids are to be indirectly used (such
as for cooling a mold) shall be plastic covered.
(8) Transformers in which the primary coil connects directly to the
branch circuit outlet shall not be subject to the requirements of
paragraphs (e) (2), (4), and (5) of this section.
(f) Bushings. (1) At the point where a power supply cord passes
through an opening in a wall, barrier, or the overall enclosure of a
toy, a suitable and substantial bushing, insulating bushing, or
equivalent shall be reliably secured in place and shall have smooth
surfaces and well-rounded edges against which the cord may bear.
(2) If a cord hole is in wood, porcelain, phenolic composition, or
other suitable insulating material, the surface of the hole is
acceptable without a bushing if the edges of the hole are smooth and
well-rounded. Where a separate insulating bushing is required, a bushing
made of ceramic material or a suitable molded composition is acceptable
if its edges are smooth and well-rounded.
(3) In no instance shall a separate bushing of wood, rubber, or any
of the hot-molded shellac-and-tar compositions be considered acceptable.
(g) Wiring. (1) The internal wiring of a toy shall consist of
suitable insulated conductors having adequate mechanical strength,
dielectric properties, and electrical capacity for the particular
application.
[[Page 526]]
(2) Wireways shall be smooth and entirely free of sharp edges,
burrs, fins, and moving parts that may abrade conductor insulation. Each
splice and connection shall be mechanically secure, shall provide
adequate and reliable electrical contact, and shall be provided with
insulation at least equivalent to that of the wire involved unless
adequate spacing between the splice and all other metal parts is
permanently assured.
(3) A wire connector for making a splice in a toy shall be a type
that is applied by a tool and for which the application force of the
tool is independent of the force applied by the operator.
(4) Soldered connections shall be made mechanically secure before
soldering.
(5) Current-carrying parts shall be made of silver, copper, a copper
alloy, or other electrically conductive material suitable for the
particular application.
(h) Strain relief. (1) A means of strain relief shall be provided to
prevent mechanical stress on a flexible cord from being transmitted to
terminals, splices, or interior wiring.
(2) If suitable auxiliary insulation is provided under a clamp for
mechanical protection, clamps of any material are acceptable for use on
Type SP-2 (as defined in the ``National Electrical Code,'' chapter 4,
article 400, pages 184-194 (1971) \2\) or equivalent rubber-insulated
cord. For heavier types of thermoplastic-insulated cord, clamps may be
without auxiliary insulation unless the clamp may damage the cord
insulation.
---------------------------------------------------------------------------
\2\ NFPA No. 70-1971, 1971 edition of National Electrical Code,
Article 400, ``Flexible Cords and Cables,'' pages 70-184 through 70-194,
published by the National Fire Protection Association, which is
incorporated by reference. Copies of this document are available from
the National Fire Protection Association, 60 Batterymarch Park, Quincy,
Massachusetts 02269. This document is also available for inspection at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC. This incorporation by reference was approved by the
Director of the Federal Register. These materials are incorporated as
they exist in the edition which has been approved by the Director of the
Federal Register and which has been filed with the Office of the Federal
Register.
---------------------------------------------------------------------------
(3) A flexible cord shall be prevented from being pushed into the
toy through the cord-entry hole if such displacement would result in a
hazardous condition.
(4) A knot in the cord shall not be considered an acceptable means
of strain relief, but a knot associated with a loop around a smooth,
fixed structural component shall be considered acceptable.
(i) Additional requirements. Except for the electrodes of a
replaceable incandescent lamp and its lampholder contacts, a potential
of more than 30 volts r.m.s. (42.4 volts peak) shall not exist between
any exposed live part in a toy and any other part or ground.
(Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a)))
[38 FR 27032, Sept. 27, 1973, as amended at 43 FR 45552, Oct. 3, 1978;
46 FR 63251, Dec. 31, 1981]
Sec. 1505.6 Performance.
(a) General. Electrically operated toys and components thereof shall
be tested by the appropriate methods described in this section and shall
pass the tests in such a manner as to provide the necessary assurance
that normal use and reasonably foreseeable damage or abuse will not
produce a hazard or a potentially hazardous condition. The toy shall be
capable of passing all applicable tests with any door, cover, handle,
operable part, or accessory placed in any normal position. A toy shall
not present a fire, casualty, or shock hazard when operated continuously
for 6 hours under conditions of normal use and reasonably foreseeable
damage or abuse, including the most hazardous position in which the toy
can be left.
(b) Enclosures. For the purposes of this section, the term enclosure
means any surface or surrounding structure which prevents access to a
real or potential hazard. An enclosure shall withstand impact,
compression, and pressure tests (see paragraphs (b)(1), (2), and (3) of
this section) without developing any openings above those specified,
reduction of electrical spacings below those specified, or other fire,
casualty, or shock hazards, including the loosening or displacement of
[[Page 527]]
components but excluding breakage of a lamp. After completion of each
test, the toy shall comply with the requirements of the dielectric
strength test described in paragraph (e)(2) of this section and, upon
visual examination, shall not evidence the development of any hazards.
Rupture of a fuse shall be considered a test failure.
(1) Impact test. A toy weighing 10 pounds or less shall be dropped
four times from a height of 3 feet onto a 2\1/2\ inch thick concrete
slab covered with 0.125 inch nominal thickness vinyl title. The impact
area shall be at least 3 square feet. The test shall be conducted while
the toy is energized and operating and with all dead metal of the toy
that may be energized connected together electrically and grounded
through a 3-ampere plug fuse. The toy shall be dropped in random
orientation. After each drop the test sample shall be allowed to come to
rest and examined and evaluated before continuing.
(2) Compression test. Any area on the surface of the enclosure that
is accessible to a child and inaccessible to flat-surface contact during
the impact test shall be subjected to a direct force of 20 pounds for 1
minute. The force shall be applied over a period of 5 seconds through
the axis of a \1/2\-inch-diameter metal rod having a flat end with the
edge rounded to a radius of one thirty-seconds of an inch to eliminate
sharp edges. The axis of the rod shall be perpendicular to the surface
being tested. During the test the toy shall rest on a flat, hard surface
in any test-convenient position.
(3) Pressure test. If any portion of the top of a toy has a flat
surface measuring 24 square inches or more and a minor dimension of at
least 3 inches, that surface shall be subjected to a direct vertical
pressure increasing to 50 pounds over a period of 5 seconds and
maintained for 1 minute. The force shall be applied through a steel ball
2 inches in diameter. During the test the toy shall be in an upright
position on a flat, horizontal solid surface.
(c) Handles and knobs--(1) General. For the purposes of tests in
this paragraph, the parts of a lifting handle on a toy that are within
seven-sixteenths of an inch of the surface to which the handle is
attached, or the parts of a lifting knob that are within one-fourth inch
of the surface to which the knob is attached, are considered to be for
support purposes, and the remainder of the handle or knob is considered
to be generally functional in nature. A handle or knob shall withstand
crushing and lifting tests (see paragraphs (c)(2) and (3) of this
section) without fracture of the handle or knob, development of an
opening that may pinch the hand, or breakage of the means used to fasten
the handle or knob in place.
(2) Crushing test. The functional portion of a handle or knob shall
be subjected to a crushign force increasing to 20 pounds over a period
of 5 seconds and maintained for 1 minute. The force shall be applied
through two flat and parallel hardwood blocks, each at least 2\1/2\
inches thick and each having dimensions slightly exceeding those of the
handle or knob being tested. The crushing force between the blocks shall
be exerted in any direction perpendicular to the major axis of the
handle or knob.
(3) Lifting test. The support portion of a handle or knob shall be
subjected to a force equal to four times the weight of the object it is
intended to support. The direction of the lifting force shall be as
intended by the design of the toy and shall be applied through a \1/2\-
inch-wide strap through or around a handle or by fingers or the
equivalent on a knob. The force shall be applied over a period of 5
seconds through the center of gravity of the toy and maintained for 1
minute.
(d) Stability. A toy shall not overturn while resting in an upright
position on a flat surface inclined 15 deg. from horizontal. No spillage
of molten material or hot liquids from containers shall occur while the
toy is operating in this position under normal conditions of use. During
this test, casters, if any, shall be in the position most likely to
result in tipping, but shall not be artificially held in one position to
prevent a natural rotation to another position.
(e) Electrical--(1) Power input. The actual current flow in a toy
without a heating element shall not exceed 110 percent of the rated
value, and shall not exceed 5.5 amperes, at rated voltage. The power
input to a toy with a
[[Page 528]]
heating element shall not exceed 105 percent of the rated value at rated
voltage. The power input rating of a toy employing one or more
incandescent lamps as the only power-consuming components shall be
considered to be the total rated wattage of such lamps. The rated
voltage shall be considered to be the mean value of a marked voltage
range.
(2) Dielectric strength. (i) A toy shall be capable of withstanding
without breakdown for 1 minute a 60-cycle-per-second (60 Hertz)
essentially sinusoidal potential of 1,000 volts applied between live
parts and any dead metal parts.
(ii) If a toy employs a low-voltage secondary winding (either in the
form of a conventional transformer or as an insulated coil of a motor),
the toy shall also be capable of withstanding without breakdown for 1
minute a sinusoidal test potential applied between the high-voltage and
low-voltage windings. The test potential shall be applied at the rated
frequency of the toy and shall have a value of 1,000 volts plus twice
the rated voltage of the high-voltage winding. The test potential shall
be supplied from a suitable capacity-testing transformer, the output
voltage of which can be regulated. The waveform of the test voltage
shall approximate a sine wave as closely as possible.
(iii) The applied test potential shall be increased rapidly and
uniformly from zero until the required test value is reached and shall
be held at that value for 1 minute. Unless otherwise specified, the toy
shall be at the maximum operating temperature reached in normal use
prior to conducting the tests.
(iv) The dielectric strength requirements of this subparagraph may
also be determined by subjecting the toy to a 60-cycle-per-second (60
Hertz) essentially sinusoidal potential of 1,200 volts for 1 second. If
the dielectric strength is determined by this method, the toy need not
be in a heated condition.
(3) Leakage current and repeated dielectric withstand tests. (i)
Both before and after being conditioned, a toy intended to operate from
a source exceeding 42.4 volts peak shall:
(A) Not have a leakage current exceeding 0.5 milliampere, except
that during the interval beginning 5 seconds and terminating 10 minutes
after the toy is first energized, the leakage current of toys with
heating elements other than lamps shall not exceed 2.5 milliamperes; and
(B) Comply with the requirements of a repeated dielectric withstand
test both with and without preheating.
(ii) All accessible parts of a toy shall be tested for leakage
current. If an insulating material is used for the enclosure or part of
the enclosure, the leakage current shall be measured using a metal foil
with an area not exceeding 10 by 20 centimeters in contact with
accessible surfaces of such insulating material. Where the accessible
surface of insulating material is less than 10 by 20 centimeters, the
metal foil shall be the same size as the surface. The metal foil shall
be so applied that it will not affect the temperature of the toy. The
accessible parts shall be tested individually, collectively, and from
one part to another.
(iii) Following the initial leakage current test, the toy shall be
cooled down or heated up to 32 deg.C. (90 deg.F.). The toy shall then
be conditioned for 48 hours in air at a temperature of 32 deg.
2 deg.C. (89.6 deg. 3.6 deg.F.) and with a
relative humidity of 90-95 percent. The specified relative humidity
shall be maintained inside a closed compartment in which a saturated
solution of potassium sulphate is kept in a suitable container. Leakage
current measurements shall be made, as specified in paragraph (e)(3)(ii)
of this section and before the toy is energized, while the toy is in the
humidity compartment.
(iv) With the connections intended for the source of supply
connected thereto and then connected to the ungrounded side of a power
supply circuit having a voltage equal to 110 percent of the rated
voltage of the toy, the leakage current through a noninductive 1,500-ohm
resistor connected between the gounded side of the supply circuit and
each dead metal part (accessible and inaccessible) shall, when stable,
be measured in accordance with the test provisions established in ANSI
Standard C 101.1-1971, ``American National Standard for Leakage Current
for Appliances,'' approved November 17,
[[Page 529]]
1970, which is incorporated by reference. Copies of this document are
available from American National Standards Institute, 1430 Broadway, New
York, New York 10018. This document is also available for inspection at
the Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC. This incorporation by reference was approved by the
Director of the Federal Register. These materials are incorporated as
they exist in the edition which has been approved by the Director of the
Federal Register and which has been filed with the Office of the Federal
Register.
(v) For a toy whose outer enclosure consists wholly or partly of
insulating material, the term dead metal part means metal foil tightly
wrapped around the exterior of the enclosure in a manner that covers,
but does not enter into, any enclosure openings.
(4) Motor operation. (i) A motor provided as part of a toy shall be
capable of driving its maximum normal load in the toy without
introducing any potentially hazardous condition. The performance of the
toy shall be considered unacceptable if, during the test, temperatures
in excess of those specified in Sec. 1505.7 for Type D surfaces are
attained on any accessible surface. The performance of the toy shall
also be considered unacceptable if the rise in temperature during the
test causes melting, scorching, embrittlement, or other evidence of
thermal damage to the insulating material used to prevent exposure of
live metal parts.
(ii) A motor-operated toy shall be tested with the motor stalled if
the construction of the toy is such that any person can touch moving
parts associated with the motor from outside the toy. The performance of
the toy shall be considered unacceptable if, during the test,
temperatures higher than those specified in Sec. 1505.8 are attained or
if temperatures higher than those specified for Type C surfaces in
Sec. 1505.7 are attained on any accessible surface of the motor. (See
also Sec. 1505.50.)
(5) Overload--(i) Motor. A motor-control switch that is a part of a
toy shall be horsepower-rated to cover the load or shall be capable of
performing acceptably when subjected to an overload test consisting of
50 cycles of operation by making and breaking the stalled-rotor current
of the toy at maximum rated voltage. There shall be no electrical or
mechanical failure nor any visible burning or pitting of the switch
contacts as a result of this test.
(ii) Switch. To determine if a motor-control switch is capable of
performing acceptably when subjected to overload conditions, the toy
shall be connected to a grounded supply circuit of rated frequency and
maximum rated voltage with the rotor of the motor locked into position.
During the test, exposed dead metal parts of the toy shall be connected
to ground through a 3-ampere plug fuse such that any single pole,
current-rupturing device will be located in the ungrounded conductor of
the supply circuit. If the toy is intended for use on direct current, or
on direct current as well as alternating current, the exposed dead metal
parts of the toy shall be so connected as to be positive with respect to
a single pole, current-rupturing device. The switch shall be operated at
a rate of not more than 10 cycles per minute. The performance of the toy
shall be considered unacceptable if the fuse in the grounding connection
is blown during the test.
(f) Hydrokinetic--(1) General. Electrically operated toy steam
engines shall be capable of performing acceptably when subjected to the
tests described in this paragraph.
(2) Preliminary test. The ultimate strength of the boiler assembly
shall first be determined by applying a hydrostatic pressure to the
boiler with all openings blocked (the pressure-relief valve, steam
exhausts, and any whistle or other accessory shall be removed and the
resulting openings sealed); however, a water or other type of gage shall
be left in place. The hydrostatic pressure shall be applied slowly and
the ultimate value which is attained shall be recorded.
(3) Pressure-relief test. A pressure gage shall be connected to the
boiler assembly which shall then be operated normally. The pressure at
which the pressure-relief valve functions shall be noted while the
engine is shut off (if a shutoff valve is provided) and with the
whistle, if any, turned off. The test
[[Page 530]]
shall be discontinued and shall be considered a failure if the observed
pressure exceeds one-fifth the value attained in the preliminary test
described in paragraph (f)(2) of this section.
(4) Operating pressure test. If the boiler is still intact and no
failure has occurred, the pressure-relief valve shall then be rendered
inoperable and all other valves (such as a whistle and exhaust from the
assembly) shall be tightly closed. Operations shall be continued until
the pressure becomes constant. This test shall be discontinued and shall
be considered a failure if the observed pressure exceeds one-third the
value attained in the preliminary test described in paragraph (f)(2) of
this section. During this test, all valves, gaskets, joints, and similar
components shall be sufficiently tightened to prevent leakage. Rupture
of the boiler or of any other fittings supplied with the engine shall be
considered a failure.
(5) Hydrostatic test. If there has been no failure, two previous
untested toys shall withstand for 1 minute a hydrostatic pressure of 5
times the pressure at which the safety valve operated or 3 times the
constant pressure observed with the pressure-relief valve inoperable,
whichever is greater. During this test, all openings shall be blocked
(the pressure-relief valve, steam exhaust from the assembly, and any
whistle or other outlet); however, a water or other type of gage shall
remain in place. Rupture of the boiler or of a gage shall be considered
a failure.
(g) Thermal--(1) General. The normal operation of a toy includes
performance in normal use and after being subjected to reasonably
foreseeable damage or abuse likely to produce the highest temperatures
or, in the case of motor-operated toys, the load that most closely
approximates the severest conditions of normal use or reasonably
foreseeable damage or abuse.
(2) Classification. Parts or surfaces of a toy are classified
according to their use or function as follows (for the purposes of
paragraph (g)(2) (v), (vi), and (vii) of this section, accessibility
shall be defined as the ability to reach a heated surface with a \1/4\-
inch-diameter rod 3 inches long as described in Sec. 1505.51(a)):
(i) Type A. A part or surface of a toy (such as a handle) likely to
be grasped by the hand or fingers for the purpose of carrying the toy or
lifting a separable lid.
(ii) Type B. A part or surface of a toy that is (a) part of a
handle, knob, or similar component, as in Type A (described in paragraph
(g)(2)(i) of this section), but which is not normally grasped or
contacted by the hand or fingers for carrying (including parts of a
handle within \7/16\ inch of the surface to which the handle is attached
and parts of a finger knob within \1/4\ inch of the surface to which the
knob is attached, if the remainder of the knob is large enough to be
grasped), or (b) a handle, knob, or part that may be touched but which
need not be grasped for carrying the toy or lifting a lid, door, or
cover (e.g., support part of a handle or knob).
(iii) Type C. A part or surface of a toy that can be touched by
casual contact or that can be touched without employing the aid of a
common household tool (screwdriver, pliers, or other similar household
tool) and that is either (a) a surface that performs an intended heating
function (e.g., the soleplate of a flat-iron, a cooking surface, or a
heating element surface), or (b) a material heated by the element and
intended to be used as the product of the toy, excluding pans, dishes,
or other containers used to hold the material to be cooked or baked if a
common utensil or other device is supplied with the toy and specific
instructions are established for using such a device to remove the
container from the heated area. (See also Sec. 1505.51(b))
(iv) Type C marked. A Type C surface which has been marked with a
precautionary statement of thermal hazards in accordance with
Sec. 1505.3(e)(2). (See also Sec. 1505.51(b))
(v) Type D. An accessible part or surface of a toy other than Types
A, B, C or E (see paragraph (g)(2) (i), (ii), (iii) and (vii) of this
paragraph).
(vi) Type D marked. A Type D surface which has been marked with a
precautionary statement of thermal hazards in accordance with
Sec. 1505.3(e)(2).
[[Page 531]]
(vii) Type E. A heated surface in an oven or other article that is
inaccessible or protected by an electrical-thermal safety interlock.
Such interlocks shall prohibit the operation of a heating device
whenever such surfaces are accessible and shall not allow accessibility
to such surfaces until the temperatures of those surfaces have been
reduced to levels below those established for Type D surfaces (paragraph
(g)(2)(v) of this section).
(3) Requirements. When tested under the conditions described in
paragraph (g)(4) of this section, a toy shall not attain a temperature
at any point sufficiently high to constitute a fire hazard or to
adversely affect any materials employed and shall not show a maximum
temperature higher than those established by Sec. Sec. 1505.7 and
1505.8. These maximum surface temperature requirements are not
applicable to educational-or hobby-type products such as lead-casting
sets and wood-burning tools which are appropriately labeled on the shelf
pack or package as being intended only for children over 12 years of age
provided that the maximum surface temperature of any such toy does not
exceed that reasonably required to accomplish the intended technical
effect. Such toys shall be provided with specific instructions and the
warning statements required by and in accordance with Sec. 1505.3 (d)
and (e), and shall be appropriately identified as educational or hobby-
type products.
(4) Test conditions--(i) General. Tests shall be conducted while the
toy is connected to a circuit of 60-cycle-per-second (60 Hertz) current
using the materials supplied with the toy or using materials otherwise
intended to be used with the toy. Following such tests, the toy shall be
energized for a 6-hour period to determine that no hazardous conditions
would result from unattended use of the toy.
(ii) Temperature. Normally, tests shall be performed at an ambient
(room) temperature of 25 deg.C. (77 deg.F.); however, a test may be
conducted at any ambient temperature within the range of 21 deg. to 30
deg.C. (69.8 deg. to 86 deg.F.).
(iii) Voltage. The toy shall be tested at the voltage indicated in
the manufacturer's rating or at 120 volts, whichever is greater.
(5) Temperature measurements--(i) General. Temperatures shall be
measured by means of instruments utilizing thermocouples of No. 30 AWG
(American Wire Gage) wire (either copper and constantan or iron and
constantan) and potentiometer-type instruments that are accurate and are
calibrated in accordance with current good laboratory practices. The
thermocouple wire shall conform with the requirements for ``special''
thermocouples as listed in the table of limits of error of thermocouples
(Table VIII) in ANSI Standard C 96.1-1964, ``American Standard for
Temperature Measurement Thermocouples,'' approved June 9, 1964, which is
incorporated by reference. Copies of this document are available from
American National Standards Institute, 1430 Broadway, New York, New York
10018. This standard is also available for inspection at the Office of
the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC. This incorporation by reference was approved by the
Director of the Office of the Federal Register. These materials are
incorporated as they exist in the edition which has been approved by the
Director of the Federal Register and which has been filed with the
Office of the Federal Register.
(ii) Test procedures. The thermocouple junction and adjacent
thermocouple lead wire shall be securely held in good thermal contact
with the surface of the material whose temperature is being measured. In
most cases, good thermal contact will result from securely taping or
cementing the thermocouple in place. If a metal surface is involved,
brazing or soldering the thermocouple to the metal may be necessary. The
surface temperatures of a toy shall be measured with the toy operating
in any unattended condition (e.g., with and without opening and closing
doors or covers) for a sufficient period of time to allow temperatures
to become constant, or, in the case of a toy with a thermostatically
controlled heating element, for a sufficient period of time to determine
the maximum surface temperature attained. A temperature shall be
considered to be constant when three successive readings taken at 15-
minute intervals indicate no change.
[[Page 532]]
(iii) Heating devices. Toy ovens, casting toys, popcorn and candy
makers, and other toys requiring the insertion of any materials or
substances shall be additionally tested by feeding crumpled strips of
newspaper and tissue paper into or onto the toy in place of the intended
materials or substances. The test strips shall be conditioned for at
least 48 hours in air at a temperature of 25 deg. 4 deg.C.
(77 deg. 7 deg.F.) and a relative humidity of 50 percent
5 percent. The test strips shall be 2 inches wide by 8
inches long before crumpling. The crumpled paper shall occupy not more
than 25 percent of the accessible volume. The performance of the toy
shall be considered unacceptable if flaming occurs within a 60-minute
period following the attainment of normal operating temperatures. If a
light bulb is used for heating purposes, the test shall be conducted
using the largest wattage bulb that can be easily inserted into the
socket.
(h) Strain-relief test. (1) The strain-relief means provided on the
flexible power cord of a toy shall be capable of withstanding a direct
pull of 35 pounds applied to the cord for 2 minutes without displacement
of the strain-relief unit or a deformation of the anchoring surface that
would produce a stress which would result in a potentially hazardous
condition. A 35-pound weight shall be attached to the cord and supported
by the toy in such a manner that the strain-relief means is stressed
from any angle that the construction of the toy permits. The test shall
be conducted with the electrical connection within the toy disconnected.
(2) The initial 2-minute test shall be conducted with the force
vector parallel to the longitudinal axis of the cord and perpendicular
to the anchoring surface of the strain-relief unit. Each test at other
angles of stress shall be conducted for periods of 1 minute. The strain-
relief means is not acceptable if, at the point of disconnection of the
cord, there is any movement of the cord to indicate that stress would
have resulted on the conections.
(3) Except for toys weighing more than 10 pounds, the strain-relief
unit and its support base shall be designed and constructed in such a
manner that no indication of stress would result which would produce a
hazard when the cord is held firmly in place 3 feet from the strain-
relief unit and the toy is dropped the 3 feet at any angle.
[38 FR 27032, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973, as amended at
43 FR 26428 June 20, 1978; 46 FR 63251, Dec. 31, 1981; 51 FR 34199,
Sept. 26, 1986]
Sec. 1505.7 Maximum acceptable surface temperatures.
The maximum acceptable surface temperatures for electrically
operated toys shall be as follows:
------------------------------------------------------------------------
Thermal Temperatures
Surface type (as described--in Sec. inertia ---------------------
1505.6 (g)(2)) type \1\ C. F.
------------------------------------------------------------------------
A...................................... 1 50 122
A...................................... 2 55 131
A...................................... 3 60 140
B...................................... 1 55 131
B...................................... 2 65 149
B...................................... 3 75 167
C (unmarked)........................... 1 65 149
C (unmarked)........................... 2 75 167
C (unmarked)........................... 3 85 185
C (unmarked)........................... 4 95 203
C marked............................... 1 70 158
C marked............................... 2 90 194
C marked............................... 3 110 230
C marked............................... 4 130 266
D (unmarked)........................... 1 55 131
D (unmarked)........................... 2 70 158
D (unmarked)........................... 3 80 176
D (unmarked)........................... 4 90 194
D marked............................... 1 60 140
D marked............................... 2 75 167
D marked............................... 3 100 212
D marked............................... 4 125 257
E...................................... (\2\) (\3\) (\3\)
------------------------------------------------------------------------
\1\ Thermal inertia types are defined in terms of lambda as follows:
Type 1: Greater than 0.0045 (e.g., most metals).
Type 2: More than 0.0005 but not more than 0.0045 (e.g., glass).
Type 3: More than 0.0001 but not more than 0.0005 (e.g., most plastics).
Type 4: 0.0001 or less (e.g., future polymeric materials).
The thermal inertia of a material can be obtained by multiplying the
thermal conductivity (cal./cm./sec./degrees C.) by the density (gm./
cm.\3\) by the specific heat (cal./gm./degrees C.).
\2\ All types.
\3\ No limit.
Sec. 1505.8 Maximum acceptable material temperatures.
The maximum acceptable material temperatures for electrically
operated toys shall be as follows (Classes 105, 130, A, and B are from
``Motors and Generators,'' Standard MG-1-1967 \1\ published by the
National Electrical Manufacturers Association):
---------------------------------------------------------------------------
\1\ Copies may be obtained from: National Electrical Manufacturers
Association, 155 East 44th Street, New York, NY 10017.
[[Page 533]]
------------------------------------------------------------------------
Material Degrees C. Degrees F.
------------------------------------------------------------------------
Capacitors.................................... (\1\) (\1\)
Class 105 insulation on windings or relays,
solenoids, etc.:
Thermocouple method \2\..................... 90 194
Resistance method........................... 110 230
Class 130 insulation system................... 110 230
Insulation:
Varnished-cloth insulation.................. 85 185
Fiber used as electrical insulation......... 90 194
------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Class A Class B Class A Class B
----------------------------------------------------------------------------------------------------------------
Insulation on coil windings of a.c. motors (not including universal
motors) and on vibrator coils:
In open motors and on vibrator coils--thermocouple or resistance 100 120 212 248
method \2\.......................................................
In totally enclosed motors--thermocouple or resistance method \2\. 105 125 221 257
Insulation on coil windings of d.c. motors and of universal motors:
In open motors:
Thermocouple method \2\......................................... 90 110 194 230
Resistance method............................................... 100 120 212 248
In totally enclosed motors:
Thermocouple method \2\......................................... 95 115 203 239
Resistance method............................................... 105 125 221 257
Phenolic composition \3\............................................ ......... 150 302 .........
Rubber- or thermoplastic-insulated wires and cords \3\.............. ......... 60 140 .........
Sealing compound.................................................... ......... (\4\) (\5\) .........
Supporting surface while the toy is operating normally.............. ......... 90 194 .........
Wood and other similar combustible material......................... ......... 90 194 .........
----------------------------------------------------------------------------------------------------------------
\1\ If the capacitor has no marked temperature limit, the maximum acceptable temperature will be assumed to be
65 C. (149 F.) for an electrolytic type and 90 C. (194 F.) for other than an electrolytic type.
\2\ The temperature indicated refers to the hottest spot on the outside surface of the coil measured by the
thermocouple method.
\3\ The limitations on rubber- and thermoplastic-insulated wires and cords and on phenolic composition do not
apply if the insulation or the phenolic has been investigated and found to have special heat-resistant
properties, or if the insulation meets the thermal requirements.
\4\ 40 less than melting point.
\5\ 104 less than melting point.
Subpart B--Policies and Interpretations
Sec. 1505.50 Stalled motor testing.
(a) Sec. 1505.6(e)(4)(ii) requires that a motor-operated toy be
tested with the motor stalled if the construction of the toy is such
that any person can touch moving parts associated with the motor from
outside the toy. The performance of the toy shall be considered
unacceptable if, during the test, temperatures higher than those
specified in Sec. 1505.8 are attained or if temperatures higher than
those specified for Type C surfaces in Sec. 1505.7 are attained on any
accessible surface of the motor.
(b) To determine if a moving part associated with the motor can be
touched from outside the toy, the Commission staff will use a \1/4\-inch
diameter rod, as referenced in Sec. 1505.4(h)(1). If the rod, when
inserted into openings in the toy, can touch any moving part associated
with the motor, the toy will be tested with the motor stalled.
(c) The requirement that temperatures higher than those specified in
Sec. 1505.8 not be attained applies to those internal components which
are described in Sec. 1505.8. Additionally, temperatures of accessible
surfaces shall not exceed those specified for Type C surfaces in
Sec. 1505.7.
(Secs. 2(q)(1)(A), 2(r), 3(e), 10(a), 74 Stat. 372, 378, 80 Stat. 1303-
1304, 83 Stat. 187-189 (15 U.S.C. 1261, 1262, 1269); sec. 30(a), 86
Stat. 1231 (15 U.S.C. 2079(a)))
[43 FR 26428, June 20, 1978]
Sec. 1505.51 Hot surfaces.
(a) Test probe. Section 1505.6(g)(2) defines accessibility, for
certain paragraphs, as the ability to reach a heated surface with a \1/
4\-inch-diameter rod 3 inches long. To test for accessibility using this
test probe, it shall be inserted no more than 3 inches into any opening
in the toy. Unless the probe contacts a surface within 3 inches of the
plane of the toy's opening, that surface is not accessible.
[[Page 534]]
(b) Accessibility of Type C and C-marked surfaces. Under
Sec. 1505.6(g)(2) (iii) and (iv), touching by casual contact or without
employing the aid of a common household tool shall be determined by use
of the accessibility test probe described in Sec. Sec. 1505.6(g)(2) and
1505.51(a).
[51 FR 34199, Sept. 26, 1986]
PART 1507--FIREWORKS DEVICES--Table of Contents
Sec.
1507.1 Scope.
1507.2 Prohibited chemicals.
1507.3 Fuses.
1507.4 Bases.
1507.5 Pyrotechnic leakage.
1507.6 Burnout and blowout.
1507.7 Handles and spikes.
1507.8 Wheel devices.
1507.9 Toy smoke devices and flitter devices.
1507.10 Rockets with sticks.
1507.11 Party poppers.
1507.12 Multiple-tube fireworks devices.
Authority: 15 U.S.C. 1261-1262, 2079(d); 21 U.S.C. 371(e).
Source: 41 FR 22935, June 8, 1976, unless otherwise noted.
Cross Reference: See also 1500.14(b)(7); 1500.17(a) (3), (8) and
(9); 1500.83(a)(27) and 1500.85(a)(2).
Sec. 1507.1 Scope.
This part 1507 prescribes requirements for those fireworks devices
(other than firecrackers) not otherwise banned under the act. Any
fireworks device (other than firecrackers) which fails to conform to
applicable requirements is a banned hazardous substance and is
prohibited from the channels of interstate commerce. Any fireworks
device not otherwise banned under the act shall not be a banned
hazardous substance by virtue of the fact that there are no applicable
requirements prescribed herein.
Sec. 1507.2 Prohibited chemicals.
Fireworks devices shall not contain any of the following chemicals:
(a) Arsenic sulfide, arsenates, or arsenites.
(b) Boron.
(c) Chlorates, except:
(1) In colored smoke mixtures in which an equal or greater amount of
sodium bicarbonate is included.
(2) In caps and party poppers.
(3) In those small items (such as ground spinners) wherein the total
powder content does not exceed 4 grams of which not greater than 15
percent (or 600 milligrams) is potassium, sodium, or barium chlorate.
(d) Gallates or gallic acid.
(e) Magnesium (magnesium/aluminum alloys, called magnalium, are
permitted).
(f) Mercury salts.
(g) Phosphorus (red or white). Except that red phosphorus is
permissible in caps and party poppers.
(h) Picrates or picric acid.
(i) Thiocyanates.
(j) Titanium, except in particle size greater than 100-mesh.
(k) Zirconium.
Sec. 1507.3 Fuses.
(a) Fireworks devices that require a fuse shall:
(1) Utilize only a fuse that has been treated or coated in such
manner as to reduce the possibility of side ignition. Devices such as
ground spinners that require a restricted orifice for proper thrust and
contain less than 6 grams of pyrotechnic composition are exempted from
Sec. 1507.3(a)(1).
(2) Utilize only a fuse which will burn at least 3 seconds but not
more than 9 seconds before ignition of the device.
(b) The fuse shall be securely attached so that it will support
either the weight of the fireworks device plus 8 ounces of dead weight
or double the weight of the device, whether is less, without separation
from the fireworks device.
[41 FR 22935, June 8, 1976, as amended at 61 FR 67200, Dec. 20, 1996; 61
FR 67200, Dec. 20, 1996]
Sec. 1507.4 Bases.
The base or bottom of fireworks devices that are operated in a
standing upright position shall have the minimum horizontal dimensions
or the diameter of the base equal to at least one-third of the height of
the device including any base or cap affixed thereto.
[[Page 535]]
Sec. 1507.5 Pyrotechnic leakage.
The pyrotechnic chamber in fireworks devices shall be sealed in a
manner that prevents leakage of the pyrotechnic composition during
shipping, handling, and normal operation.
Sec. 1507.6 Burnout and blowout.
The pyrotechnic chamber in fireworks devices shall be constructed in
a manner to allow functioning in a normal manner without burnout or
blowout.