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SUBCHAPTER C-FEDERAL HAZARDOUS SUBSTANCES ACT REGULATIONS

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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 vola

tile 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 selfpressurized 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

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AUTHORITY: 15 U.S.C. 1261-1278.

SOURCE: 38 FR 27012, Sept. 27, 1973, unless otherwise noted.

$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 § 1500.3(a)(1)).

§ 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)).

§ 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 Co

lumbia 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).

substance if,

(C) Any radioactive 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.

(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) Toric 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 para

graph (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 § 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

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;

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(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

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

203-051 D-14

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