[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1500.3]

[Page 408-416]
 
                     TITLE 16--COMMERCIAL PRACTICES
 
             CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
 
PART 1500_HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND ENFORCEMENT REGULATIONS--Table of Contents
 
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 409]]

    (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 410]]

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 411]]

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 412]]

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 413]]

    (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 414]]

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 415]]

    (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 416]]

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]