Title 16—Commercial Practices--Volume 1
PART 1500—HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND ENFORCEMENT REGULATIONS
§ 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 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.
(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 § 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;
(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, and to emphasize in vitro testing methods, 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 hours or less by the method described in § 1500.40.
(iii) A substance that produces a result of ‘highly toxic’ in any of the approved test methods described in the CPSC's animal testing policy set forth in 16 CFR 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data.
(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. “Toxic” applies to any substance that is “toxic” (but not “highly toxic”) on the basis of human experience. 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 § 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 § 1500.40.
(D) 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 can be labeled as such, based on the outcome of any of the approved test methods described in the CPSC's animal testing policy set forth in § 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: Existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data.
(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 a weight-of-evidence analysis suggests that it is corrosive, or validated in vitro test method suggests that it is corrosive, or if, when tested by the in vivo technique described in § 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. A substance could also be labeled corrosive based on the outcome of any of the approved test methods described in the CPSC's animal testing policy set forth in 16 CFR 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: Existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data.
(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 1500.41; and/or a substance that can be considered a primary irritant based on the outcome of any of the approved test methods described in the CPSC's animal testing policy set forth in 16 CFR 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data. 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 1500.42; and/or means a substance that can be considered an eye irritant based on the outcome of any of the approved test methods described in the CPSC's animal testing policy set forth in 16 CFR 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data.
(5) The definition of strong sensitizer in section 2(k) of the Federal Hazardous Substances Act (restated in paragraph (b)(9) of this section) is supplemented by the following definitions:
(i) Sensitizer. A sensitizer is a substance that is capable of inducing a state of immunologically mediated hypersensitivity (including allergic photosensitivity) following a variable period of exposure to that substance. Hypersensitivity to a substance will become evident by an allergic reaction elicited upon reexposure to the same substance.
(ii) Significant potential for causing hypersensitivity. (A) Before designating any substance a “strong sensitizer,” the Commission shall find that the substance has significant potential for causing hypersensitivity. Significant potential for causing hypersensitivity is a relative determination that must be made separately for each substance. The determination may be based on documented medical evidence of hypersensitivity reactions upon subsequent exposure to the same substance obtained from epidemiological surveys or case histories; controlled in vivo or in vitro experimental studies; susceptibility profiles ( e.g., genetics, age, gender, atopic status) in non-sensitized or allergic subjects; and chemical or functional properties of the substance.
(B) In determining whether a substance is a “strong” sensitizer, the Commission shall consider the available data for a number of factors, following a weight-of-evidence approach. The following factors (if available), ranked in descending order of importance, should be considered: well-conducted clinical and diagnostic studies, epidemiological studies, with a preference for general population studies over occupational studies, well-conducted animal studies, well-conducted in vitro test studies, cross-reactivity data, and case histories.
(C) Additional consideration may be given to Quantitative Structure-Activity Relationships (QSARs), in silico data, specific human sensitization threshold values, other data on potency and sensitizer bioavailability, if data are available and the methods validated. Bioavailability is the dose of the allergen available to interact with a tissue. Bioavailability is a reflection of how well the skin or another organ can absorb the allergen and the actual penetrating ability of the allergen, including factors such as size and composition of the chemical.
(D) Criteria for a “well-conducted” study would include: validated outcomes, relevant dosing, route of administration, and use of appropriate controls. Studies should be carried out according to national and/or international test guidelines and according to good laboratory practice (GLP), compliance with good clinical practice (GCP), and good epidemiological practice (GEP).
(E) Before the Commission designates any substance as a “strong” sensitizer, frequency of occurrence and range of severity of reactions in exposed subpopulations having average or high susceptibility will be considered. The minimal severity of a reaction for the purpose of designating a material as a “strong sensitizer” is a clinically important reaction. A clinically important reaction would be considered one with a significant impact on quality of life. Consideration should be given to the location of the hypersensitivity response, such as the face, hands, and feet as well as persistence of clinical manifestations. For example, strong sensitizers may produce substantial illness, including any or all of the following: substantial physiological effects, such as discomfort and distress, substantial hardship, functional or structural impairment, persistent morbidity, or in rare cases, mortality.
(iii) Normal living tissue. The allergic hypersensitivity reaction occurs in normal living tissues, including the skin, mucous membranes ( e.g., ocular, oral), and other organ systems, such as the respiratory tract and 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 °F (−6.7 °C) as determined by the test method described at § 1500.43a, except that, any mixture having one component or more with a flashpoint higher than 20 °F (−6.7 °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 °F (−6.7 °C) and below 100 °F (37.8 °C), as determined by the method described at § 1500.43a, except that:
(A) Any mixture having one component or more with a flashpoint at or above 100 °F (37.8 °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 °F (37.8 °C) to and including 150 °F (65.6 °C) as determined by the test method described at § 1500.43a, except that:
(A) Any mixture having one component or more with a flashpoint higher than 150 °F (65.6 °C) which comprises at least 99 percent of the total volume of 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 § 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 § 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 § 1500.43a; and
(B) No change has been made to the formulation or labeling of such substance or product after the effective date of § 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 °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 § 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 § 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 § 1500.43a is less than 20 °F (−6.7 °C).
(viii) Flammable contents of self-pressurized container means contents of a self-pressurized container that, when tested by the method described in § 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 °F. for 2 days or less.
(C) If it erupts from its opened container at a temperature of 130 °F. or less after having been held in the closed container at 130 °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.
(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.
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 § 1500.3(c)(6)(iv), as amended.
(b)(10) Extremely flammable shall apply to any substance which has a flashpoint at or below 20 °F. as determined by the Tagliabue Open Cup Tester; flammable shall apply to any substance which has a flashpoint of above 20 °F., to and including 80 °F., as determined by the Tagliabue Open Cup Tester; and combustible shall apply to any substance which has a flashpoint above 80 °F. to and including 150 °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 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 °F. as determined by the method described in § 1500.43.
(ii) Flammable means any substance that has a flashpoint of above 20 °F., to and including 80 °F., as determined by the method described in § 1500.43.
§ 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.
§ 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 § 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.
§ 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) Metal-cored candlewicks that have a lead content of more than 0.06 percent of the total weight of the metal core, and candles made with such wicks.
(b) [Reserved]
§ 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 § 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.
§ 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 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 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.
(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 “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.
(ii) California candles.
(iii) Spike and handle cylindrical fountains.
(A) Spike fountains.
(B) Handle fountains.
(iv) Roman Candles.
(v) Rockets with sticks.
(vi) Wheels.
(vii) Illuminating torches.
(viii) Sparklers.
On the front and back panels:
On the side, front, back, top, or bottom panel.
(ix) Mines and shells.
(x) Whistles without report.
(xi) Toy smoke devices and flitter devices.
(xii) Helicopter-type rockets.
(xiii) Party poppers.
(xiv) Missile-type rockets.
(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 § 1500.121 of these regulations. (See also § 1500.17(a) (3), (8) and (9); § 1500.83(a)(27); § 1500.85(a)(2); and part 1507).
(8) Art materials.
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.
( 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 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 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
(G) Precautionary Statements
(ii) The following shall apply with respect to the standard for art materials set forth in § 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 § 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 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 § 1500.135 and a definition of “chronic toxicity” is provided in § 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 § 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 § 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 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.
(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.
§ 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 § 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 § 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 § 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.”
§ 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 § 1500.3(b)(10)).
(2) Carbon tetrachloride and mixtures containing it (including carbon tetrachloride and mixtures containing it 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 § 1500.14(b)(7); § 1500.17(a) (8) and (9); § 1500.83(a)(27); § 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 § 1500.17(a)(6) are revoked as to the subject products manufactured after February 27, 1978.
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).
(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 § 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 § 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 § 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.
(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 § 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 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.
(13)(i) Candles made with metal-cored wicks. Candles manufactured or imported on or after October 15, 2003, made with metal-cored candlewicks, unless:
(A) The metal core of each candlewick has a lead content (calculated as the metal) of not more than 0.06 percent of the total weight of the metal core; and
(B) Each outer container or wrapper in which candles subject to paragraph (a)(13)(i)(A) of this section are shipped, including each outer container or wrapper in which such candles are distributed to a retail outlet, is labeled “Conforms to 16 CFR 1500.17(a)(13).” For purposes of this paragraph (B), the term “outer container or wrapper” does not include the immediate container in which candle(s) is/are intended to be displayed at retail or during use in the home, unless that container or wrapper is also the only container or wrapper in which the candle(s) is/are shipped to a retailer.
(ii) Metal-cored candlewicks. Metal-cored candlewicks manufactured or imported on or after October 15, 2003, unless:
(A) The metal core of each candlewick has a lead content (calculated as the metal) of not more than 0.06 percent of the total weight of the metal core; and
(B) Each outer container or wrapper in which candlewicks subject to paragraph (a)(13)(ii)(A) of this section is shipped, including each outer container or wrapper of a shipment distributed to a retail outlet, is labeled “Conforms to 16 CFR 1500.17(a)(13).” For purposes of this paragraph (B), the term “outer container or wrapper” does not include the immediate container in which candlewick(s) is/are intended to be displayed or sold at retail, unless that container or wrapper is also the only container or wrapper in which the candlewick(s) is/are shipped to a retailer.
(iii) Findings —(A) General. To issue a rule under 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 Commission must make certain findings and include them in the regulation. These findings are discussed in paragraphs (a)(13)(iii)(B) through (D) of this section.
(B) Voluntary standard. One alternative to the ban that the Commission considered is to take no mandatory action, and to depend on a voluntary standard. One organization has a standard for candlewicks intended to address the potential for substantial illness posed by such wicks and candles with such wicks. The Commission has found that the standard is technically unsound and that substantial compliance with it is unlikely. Furthermore, there is no evidence that the standard has been adopted and implemented by candlewick or candle manufacturers.
(C) Relationship of benefits to costs. The Commission estimates that the ban will reduce the potential for exposure to lead and resulting lead poisoning because there is no “safe” level of lead in the blood. The annual cost to the candle/wick industry of the ban is estimated by the Commission to be in the range of $100,000 to $300,000. On a percentage basis these costs represent only 0.005 to 0.015 percent of the overall value of candle shipments in 2000, which was approximately $2 billion. Accordingly, 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: no action; labeling all metal-cored candles with wicks containing more than 0.06 percent lead by weight of the metal; recordkeeping for shipments of wicks containing 0.06 percent or less lead by weight of the metal and of candles with such wicks; and relying on the voluntary standard. Neither no action, nor labeling, nor reliance on the voluntary standard would adequately reduce the risk of illness. Recordkeeping for shipments of wicks and of candles was not the least burdensome requirement that would prevent or adequately reduce the risk of illness. Therefore the Commission finds that a ban on candlewicks containing more than 0.06 percent lead by weight of the metal and candles with such wicks is the least burdensome requirement that would prevent or adequately reduce the risk of illness.
(b) [Reserved]
§ 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 § 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 causing laceration, puncture wound injury, or other similar injury. (But see § 1500.86(a)(2)); (See also §§ 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) [Reserved]
(6) Any article known as a “baby-bouncer” or “walker-jumper” and any other similar article (referred to in this paragraph as “article(s)”), except an infant walker subject to part 1216, which is intended to support very young children while sitting, 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 § 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 § 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 § 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 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 § 1512.2(a) of this chapter (except a bicycle that is a “track bicycle” or a “one-of-a-kind bicycle” as defined in § 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 §§ 1512.5(c)(3), 1512.9(a), 1512.18(e) and 1512.18(f) which become effective November 13, 1976.
(15) Any rattle (as defined in § 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 (But see § 1500.86(a)(9)):
(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. 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 § 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 § 1500.86(a)(7) and dive sticks and similar articles that maintain a compressive force of less than 5-lbf under the test at § 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 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 § 1505.1(a)(1)) that is introduced into interstate commerce and which does not comply with the requirements of part 1505 of this chapter.
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.
(2) [Reserved]
§ 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 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:
(2) Any latex balloon, or toy or game that contains a latex balloon, shall bear the following cautionary statement:
(3)(i) Any small ball intended for children three years of age or older shall bear the following cautionary statement:
(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:
(4)(i) Any marble intended for children three years of age or older shall bear the following cautionary statement:
(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:
(c) Age of intended user. In determining the ages of the children for which any toy or article subject to this 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 § 1500.19(b) and (f), with the following clarifications and modifications.
(1) All labeling statements required by § 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 § 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 § 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.
(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 § 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 § 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 § 1500.19(b)(1), a small ball subject to § 1500.19(b)(3), a marble subject to § 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:
(ii) In the case of a balloon subject to § 1500.19(b)(2) or a toy or game containing such a balloon, the principal display panel bears the statement:
(g) Alternative for products manufactured outside the United States. In the case of a product subject to the labeling requirements of § 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.
§ 1500.20   Labeling requirement for advertising toys and games.
(a) Scope. This section applies to catalogue and other printed material advertisements which provide a direct means of purchase or order of products requiring cautionary labeling under sections 24(a) and (b) of the FHSA.
(b) Effective Date. Under the Consumer Product Safety Improvement Act of 2008, Public Law 110-314, 122 Stat. 3016 (August 14, 2008), (“CPSIA”), the effective date of the CPSIA's amendment to Section 24 of the FHSA to require cautionary statements in catalogues and other printed materials is February 10, 2009. By this rule, the Commission is providing a grace period of 180 days, or until August 9, 2009, during which catalogues and other printed materials printed prior to February 10, 2009, may be distributed without such cautionary statements. Catalogues and other printed materials that are printed on or after February 10, 2009, must have the required cautionary statements. All catalogues and other printed materials distributed on or after August 9, 2009, must comply with this rule. This rule addresses only catalogues and other printed materials; however, the CPSIA extends the requirements for cautionary statements to Internet advertisements as well. Internet advertisements must comply with Section 24 of the FHSA as amended by the CPSIA no later than December 12, 2008.
(c) 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 a 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 other 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 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) Direct means of purchase or order means any method of purchase that allows the purchaser to order the product without being in the physical presence of the product. Advertising that provides a direct means of purchase or order of a product would include catalogues or other printed advertising material that contain order blanks, telephone numbers or fax numbers for placing orders, and Internet Web sites that enable consumers to purchase a product online or through the use of a telephone number or fax number provided on the Internet Web site.
(d) Advertising requirements. Any toy or game that requires a cautionary statement about the choking hazard associated with small parts, balloons, small balls, or marbles must bear that cautionary statement in the product's advertising if the advertising provides a direct means to purchase or order the product.
(1) The advertising for 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:
(2) The advertising for any latex balloon, or toy or game that contains a latex balloon, shall bear the following cautionary statement:
(3)(i) The advertising for any small ball intended for children three years of age or older shall bear the following cautionary statement:
(ii) The advertising for 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:
(4)(i) The advertising for any marble intended for children three years of age or older shall bear the following cautionary statement:
(ii) The advertising for 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:
(e) Abbreviated warnings for catalogues and other printed materials. Abbreviated versions of the required cautionary statements are permitted in each individual product advertisement, provided that the corresponding full cautionary statements appear in the catalogue and a statement referring to the precise location of the full cautionary statements—such as the page number on which the cautionary statements can be found—is located at the bottom of each catalogue page that contains one or more abbreviated cautionary statements. If abbreviated cautionary statements are used:
(1) The full cautionary statements associated with the abbreviated cautionary statements shall appear:
(i) Near the beginning of the catalogue, before any catalogue pages that contain advertisements of products available for purchase, or
(ii) Adjacent to the ordering information or order form in the catalogue.
(2) The full cautionary statements shall be in conspicuous and legible type in contrast by typography, layout or color.
(3) The full cautionary statements shall be clearly numbered according to the following scheme:
1 See figure 1.
2 See Figure 2.
3 See Figure 3.
4 See Figure 4.
5 See Figure 5.
6 See Figure 6.
(4) The abbreviated cautionary statements shall consist of items 1500.20(e)(3)(i) through 1500.20(e)(3)(iv):
(i) A safety alert symbol substantially similar to that shown in figure 7.
(ii) The phrase, “CHOKING HAZARD,” written in capital letters.
(iii) Numbers, separated by commas and enclosed within a single set of parentheses, that identify the applicable cautionary statements for the product being advertised, followed by a period. These numbers shall match the numbers used to identify each full cautionary statement, as specified in 1500.20(e)(2).
(iv) A single prohibited age range written as either “Not for under 3 yrs” or “Not for under 8 yrs,” based on the most restrictive age range for all required cautionary statements for that product. Thus, if an advertised product requires the cautionary statement specified in 16 CFR 1500.19(b)(2), the prohibited age range in the abbreviated cautionary statement shall be “Not for under 8 yrs.”
(v) For example, see Figure 8 for the abbreviated cautionary statement for an advertisement of a product that requires the cautionary statements specified in 16 CFR 1500.19(b)(1) and 16 CFR 1500.19(b)(2).
(f) Alternatives to cautionary statements for individual product advertisements in catalogues and other printed materials. Multiple identical full or abbreviated cautionary statements may be replaced with a single full cautionary statement under the following circumstances:
(1) If all products available for purchase within a catalogue require the same cautionary statement, that cautionary statement, in full, may appear on the front cover, or equally conspicuous location, of the catalogue in lieu of repeating the cautionary statement within the catalogue, provided that it is communicated to consumers that the cautionary statement applies to all products in the catalogue.
(2) If all products on one catalogue page or on two facing catalogue pages require the same cautionary statement, that cautionary statement, in full, may appear at the top of the page or pages in lieu of repeating the cautionary statement in each product advertisement, provided that it is communicated to consumers that the cautionary statement applies to all products on the catalogue page or pages.
(g) Prominence and conspicuousness of labeling statements. The type size of abbreviated cautionary statements shall be reasonably related to the type size of any other printed matter in the product advertisement, and must be in conspicuous and legible type by typography, layout, or color with other printed matter in the advertisement and separated from other graphic matter.
(h) Business to Business Catalogue Exception. The requirements of section 24(c)of the Federal Hazardous Substances Act, as amended by section 105 of the CPSIA, do not apply to catalogues and other printed materials distributed solely between businesses unless the recipient business is one that could be expected to be purchasing the product for the use of children (instead of for resale, e.g.). Examples of businesses that can be expected to be purchasing products for the use of children include day care centers, schools, and churches.
§ 1500.40   Method of testing toxic substances.
Guidelines for testing the toxicity of substances, including testing that does not require animals, are presented in the CPSC's animal testing policy set forth in 16 CFR 1500.232. A weight-of-evidence analysis, including any of the following: existing human and animal data, structure activity relationships, physicochemical properties; and chemical reactivity, or validated in vitro or in silico testing are recommended to evaluate existing information before in vivo tests are considered. If in vivo testing is conducted, a sequential testing strategy is recommended to reduce the number of test animals. The method of testing the toxic substances referred to in § 1500.3(c)(1) and (2) 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.
Dimensions of Sleeves for Acute Dermal Toxicity Test
[Test animal—Rabbits]
(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.
§ 1500.41   Method of testing primary irritant substances.
Guidelines for testing the dermal irritation and corrosivity properties of substances, including testing that does not require animals, are presented in the CPSC's animal testing policy set forth in 16 CFR 1500.232. A weight-of-evidence analysis or a validated in vitro test method is recommended to evaluate existing information before in vivo tests are considered. This analysis should include all of the following that are available: human and animal data, structure activity relationships, physicochemical properties, and dermal toxicity. If in vivo testing is conducted, a sequential testing strategy is recommended to reduce the number of test animals. The method of testing the dermal corrosivity and primary irritation of substances referred to in § 1500.3(c)(3) and (4), respectively, is a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. 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:
1 The “value” recorded for each reading is the average value of the six or more animals subject to the test.
§ 1500.42   Test for eye irritants.
Guidelines for in vivo and in vitro testing of ocular irritation of substances, including testing that does not require animals, are presented in the CPSC's animal testing policy set forth in 16 CFR 1500.232. A weight-of-evidence analysis or a validated in vitro test method is recommended to evaluate existing information before in vivo tests are considered. This analysis should include any of the following: Existing human and animal data on ocular or dermal irritation, structure activity relationships, physicochemical properties, and chemical reactivity. If in vivo testing is conducted, a sequential testing strategy is recommended to reduce the number of test animals. Additionally, the routine use of topical anesthetics, systemic analgesics, and humane endpoints to avoid or minimize pain and distress in ocular safety testing is recommended.
(a)(1) In the method of testing the ocular irritation of a substance referred to in § 1500.3(c)(4), 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.
(c) To assist testing laboratories and others interested in interpreting ocular irritation test results, the CPSC animal testing policy Web page at http://www.cpsc.gov/library/animaltesting.html will contain the scoring system defined in the U.S. EPA's Test Guideline, OPPTS 870.2400: Acute Eye Irritation 1 or the OECD Test Guideline 405: Acute Eye Irritation/Corrosion. 2
1 EPA. 1998. Health Effects Test Guidelines, OPPTS 870.2400 Acute Eye Irritation. EPA 712-C-98-195. Washington, DC: U.S. Environmental Protection Agency. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf )
2 OECD. 2002. OECD Guideline for the Testing of Chemicals 405: Acute Eye Irritation/Corrosion. Paris: Organisation for Economic Co-operation and Development. (Available: http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf )
§ 1500.43   Method of test for flashpoint of volatile flammable materials by Tagliabue open-cup apparatus.
1. (a) This method describes a test procedure for the determination of open-cup flashpoints of volatile flammable materials having flashpoints below 175 °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.
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.
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:
(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 °F., use the ASTM Tag Closed Tester Thermometer, range of + 20 to + 230 °F., in 1 °F. divisions, and conforming to thermometer 9F. of ASTM Standard E 1. For flashpoints from 20 °F. to 40 °F., use ASTM Tag Closed Tester, Low Range, Thermometer 57F. For flashpoints below 20 °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 °F.
(d) Glass test cup. Glass test cup (Fig. 2), of molded clear glass, annealed, heat-resistant, and free from surface defects.
(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.
(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 × 28 inches, are fastened together along the 28-inch side, preferably by hinges. A triangular sheet, 24 inches × 24 inches × 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.
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 2±0.5 °F. per minute. With viscous materials this rate of heating cannot always be obtained.
5. Determine an approximate flashpoint by passing the taper flame across the sample at intervals of 2 °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.
6. Repeat the procedure by cooling a fresh portion of the sample, the glass cup, the bath solution, and the thermometer at least 20 °F. below the approximate flashpoint. Resume heating, and pass the taper flame across the sample at two intervals of 2 °F. until the flashpoint occurs.
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.
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;
(ii) Specifications for ispropanol, flash point check grade. Isopropanol shall conform to the following requirements:
(b) Calculate a correction factor as follows:
9. (a) For hydrocarbon solvents having flashpoints between 60 °F. and 110 °F., repeatability is ±2 °F. and the reproducibility is ±5 °F.
(b) If results from two tests differ by more than 10 °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).
The test apparatus and procedure described in § 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 § 1500.3(c)(6)(iv), as amended.
§ 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 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 °F (25 °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 § 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 § 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 °C (9 °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 °C (9 °F).
(iii) The procedure is then repeated at 1 °C (2 °F) intervals until the flashpoint is determined to the nearest 1 °C (2 °F).
(iv) If improved accuracy is desired the procedure is repeated at 0.5 °C (1 °F). Test procedures are set forth in detail at § 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 °C (212 °F). The essential dimensions and requirements are shown in figure 1 and table 3, and are described in § 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 °C (18 °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, °C = S c —0.25 (101.3—A)
(ii) Target flashpoint, °C = S c —0.03 (760-B)
(iii) Target flashpoint, °F = S f —0.06 (760-B)
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 °C (10 to 20 °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 °C (10 to 20 °F) below the target temperature.
5 If the target or specification temperature is not less than 5 °C (40 °F) crushed ice and water may be used as charging (cooling) fluid. If below 5 °C (40 °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 °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 °C (5 °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 § 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 § 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 § 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.
(iii) The sample is deemed to have flashed when a large flame appears and instantaneously propagates itself over the surface of the sample (see § 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 °C (10 to 20 °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 °C (10 to 20 °F) below the expected temperature (See § 1500.43a(j)(5)).
(ii) Caution: Do not cool the sample block below −38 °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 °C (5 °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 § 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 °C (9 °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 § 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 § 1500.43a(j)(4)(iii) repeat the procedure given in § 1500.43a(j)(2) or (3), and in § 1500.43a(j)(4), testing a new specimen at a temperature 5 °C (9 °F) below that at which the flash was observed.
(ii) If necessary, repeat the procedure in § 1500.43a(j)(5)(i), lowering the temperature 5 °C (9 °F) each time, until no flash is observed. 9
(iii) Proceed to § 1500.43a(j)(7).
(6)(i) If no flash was observed in § 1500.43a(j)(4)(iii) repeat the procedure given in § 1500.43a(j)(2) or (3), and in § 1500.43a(j)(4), testing a fresh specimen at a temperature 5 °C (9 °F) above that at which the specimen was tested in § 1500.43a(j)(4)(iii).
(ii) If necessary repeat the procedure in § 1500.43a(j)(6)(i), above, raising the temperature 5 °C (9 °F) each time until a flash is observed. 9
(7) Having established a flash within two temperatures 5 °C (9 °F) apart, repeat the procedure at 1 °C (2 °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 § 1500.43a(j)(7) will be to the nearest 1 °C (2 °F). If improved accuracy is desired (that is, to the nearest 0.5 °C (1 °F)), test a fresh specimen at a temperature 0.5 °C (1 °F) below that at which the flash was observed in § 1500.43a(j)(7). If no flash is observed, the temperature recorded in § 1500.43a(j)(7), is the flashpoint to the nearest 0.5 °C (1 °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 (°C) = C + 0.25 (101.3-A)
(2) Corrected flashpoint (°F) = F + 0.06 (760-B)
(3) Corrected flashpoint (°C) = C + 0.03 (760-B)
(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 4±0.5 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 °C (0.2 °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.
(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 2.00±0.05 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 § 1500.43a(i) or Method B in § 1500.43a(j), determine the flashpoint of the specimen which has been added to the tester in accordance with § 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
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
Table 3—Essential Dimensions of Flash Test Apparatus A B
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.
§ 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 × 1 inch wide × 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 °F. and 86 °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 CO 2 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.
§ 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.
§ 1500.46   Method for determining flashpoint of extremely flammable contents of self-pressurized containers.
Use the apparatus described in § 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 °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 § 1500.43a.
§ 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 §§ 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 § 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 § 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 § 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 §§ 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 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 §§ 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 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 § 1500.48, the English figures shall be used. The metric approximations are provided in parentheses for convenience and information only.