16 CFR Part 1500 — Hazardous Substances and Articles: Administration and Enforcement Regulations

PART 1500—HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND ENFORCEMENT REGULATIONS Authority: 15 U.S.C. 1261-1278. Source: 38 FR 27012, Sept. 27, 1973, unless otherwise noted. § 1500.1 Scope of subchapter. Set forth in this subchapter C are the regulations of the Consumer Product Safety Commission issued pursuant to and for the implementation of the Federal Hazardous Substances Act as amended (see § 1500.3(a)(1)). § 1500.2 Authority. Authority under the Federal Hazardous Substances Act is vested in the Consumer Product Safety Commission by section 30(a) of the Consumer Product Safety Act (15 U.S.C. 2079(a)). § 1500.3 Definitions. (a) Certain terms used in this part. (1) Act (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 (b) Statutory definitions. (1) Territory (2) Interstate commerce (3) Person (4)(i) Hazardous substance (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 (iii) Hazardous substance (5) Toxic (6)(i) Highly toxic (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 (8) Irritant (9) Strong sensitizer (10) The terms extremely flammable, flammable, combustible (11) Radioactive substance (12) Label (13) Immediate container (14) Misbranded hazardous substance (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 (I) Instructions for handling and storage of packages which require special care in handling or storage; and (J) The statement ( 1 2 (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 (15)(i) Banned hazardous substance (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, 1 2 (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, Federal Register (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. (1) To provide flexibility as to the number of animals tested, and to emphasize in vitro Highly toxic (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. The number of animals tested shall be sufficient to give a statistically significant result and shall be in conformity with good pharmacological practices. (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 in silico (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 (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 in vitro in silico (ii) Chronic toxicity. (A) For Carcinogens. (B) For Neurotoxicological Toxicants. (C) For Developmental or Reproductive Toxicants. (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 in vivo in vitro in silico (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 Primary irritant in vitro in silico Eye irritant in vitro in silico (5) The definition of strong sensitizer (i) Sensitizer. (ii) Significant potential for causing hypersensitivity. Significant potential for causing hypersensitivity in vivo in vitro e.g., (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 (C) Additional consideration may be given to Quantitative Structure-Activity Relationships (QSARs), in silico (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. e.g., (6) The Consumer Product Safety Commission, by the regulations published in this section, defines the terms extremely flammable, flammable, combustible, (i) The term extremely flammable (ii) The term flammable (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 (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 (vi) Flammable solid (vii) Extremely flammable contents of self-pressurized container (viii) Flammable contents of self-pressurized container (7) The definition of hazardous substance (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 (iii) Proximate result (iv) Reasonably foreseeable handling or use (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 (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 (ii) Conspicuously prominently conspicuous Note: The definitions of extremely flammable, flammable, combustible (b)(10) Extremely flammable flammable combustible flammable, combustible, extremely flammable (c)(6)(i) Extremely flammable (ii) Flammable [38 FR 27012, Sept. 27, 1973, as amended at 38 FR 30105, Nov. 1, 1973; 49 FR 22465, May 30, 1984; 51 FR 28536, Aug. 8, 1986; 51 FR 29096, Aug. 14, 1986; 51 FR 30209, Aug. 25, 1986; 57 FR 46669, Oct. 9, 1992; 77 FR 73293, Dec. 10, 2012; 79 FR 8831, Feb. 14, 2014; 83 FR 8341, Feb. 27, 2018] § 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] [38 FR 27012, Sept. 27, 1973, as amended at 68 FR 19147, Apr. 18, 2003] § 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. (2) Ethylene glycol. (3) Benzene, toluene, xylene, petroleum distillates. (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 (5) Turpentine. (6) Charcoal. (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 3/16 13/16 (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. (i) Fountains. Warning (or Caution) FLAMMABLE (or EMITS SHOWERS OF SPARKS, if more descriptive). Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Place on level surface. Light fuse and get away. (ii) California candles. Warning (or Caution) Emits Showers of Sparks Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Hold in hand at bottom of tube. Point away from body so that neither end points toward body. (iii) Spike and handle cylindrical fountains. (A) Spike fountains. Warning (or Caution) Emits Showers of Sparks Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Stick firmly in ground in an upright position. Do not hold in hand. Light fuse and get away. (B) Handle fountains. Warning (or Caution) Emits Showers of Sparks Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Hold in hand—point away from body. Light fuse. (iv) Roman Candles. Warning (or Caution) Shoots Flaming Balls Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Stick butt end in ground. Do not hold in hand. Light fuse and get away. (v) Rockets with sticks. Warning (or Caution) Flammable Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Place in wooden trough or iron pipe at 75° angle, pointing away from people or flammable material. Do not hold in hand. Light fuse and get away. (vi) Wheels. Warning (or Caution) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Attach securely by means of a nail through the hole (or place on hard flat surface, for ground spinners). Light fuse and get away. (vii) Illuminating torches. Warning (or Caution) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Hold in hand—point away from body, clothing, or other flammable material (or place upright on level ground. Do not hold in hand, if more descriptive). Light fuse (or light fuse and get away, if more descriptive). (viii) Sparklers. On the front and back panels: Warning (or Caution) Flammable On the side, front, back, top, or bottom panel. Caution Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Do not touch glowing wire (or do not touch hot plastic, wood, etc., if more descriptive). Hold in hand with arm extended away from body. Keep burning end or sparks away from wearing apparel or other flammable material. (ix) Mines and shells. Warning (or Caution) Emits Showers of Sparks (or Shoots Flaming Balls, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Place on hard smooth surface (or place upright on level ground, if more descriptive). Do not hold in hand. Light fuse and get away. (x) Whistles without report. Warning (or Caution) Flammable SHOOTS WHISTLE IN AIR (if applicable) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Do not hold in hand. Light fuse and get away. (xi) Toy smoke devices and flitter devices. Warning (or Caution) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Do not hold in hand. Light fuse and get away. (xii) Helicopter-type rockets. Warning (or Caution) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Place on hard, open surface. Light fuse and get away. (xiii) Party poppers. Warning (or Caution) Flammable Use only under [close] adult supervision. (Use of the word close is optional.) Do not point either end toward face or other person. Hold in hand—jerk string. (xiv) Missile-type rockets. Warning (or Caution) Flammable (or Emits Showers of Sparks, if More Descriptive) Use only under [close] adult supervision. (Use of the word close is optional.) For outdoor use only. Place on hard, open surface. Light fuse and get away. (xv) Labeling—General. (8) Art materials. Note: The Labeling of Hazardous Art Materials Act (“LHAMA”), 15 U.S.C. 1277 (Pub. L. 100-695, enacted November 18, 1988) provides that, as of November 18, 1990, “the requirements for the labeling of art materials set forth in the version of the standard of the American Society for Testing and Materials [“ASTM”] designated D-4236 that is in effect on [November 18, 1988] * * * shall be deemed to be a regulation issued by the Commission under section 3(b)” of the Federal Hazardous Substances Act, 15 U.S.C. 1262(b). For the convenience of interested persons, the Commission is including the requirements of ASTM D-4236 in paragraph (b)(8)(i) of this section, along with other requirements (stated in paragraph (b)(8)(ii) of this section) made applicable to art materials by the LHAMA. The substance of the requirements specified in LHAMA became effective on November 18, 1990, as mandated by Congress. (i) ASTM D-4236 Scope 1 11 ( 2 ( 3 ( 4 (B) Descriptions of Terms Specific to This Standard. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( 8 ( 9 ( 10 ( 11 ( 12 (C) Requirements. ( 1 ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( iii ( iv (D) Determination of Labeling. ( 1 ( 2 ( i ( ii ( iii ( iv ( v ( vi ( vii ( 3 (E) Labeling Practices—( 1 i ( ii ( iii ( 2 ( 3 ( 4 ( 5 ( 6 ( 7 ( i ( ii ( iii ( 8 1 3 5 ( 9 ( i ( ii 1 ( 10 ( 11 (F) chronic Hazard Statements MAY CAUSE STERILITY. CONTACT MAY CAUSE PERMANENT EYE DAMAGE. MAY BE HARMFUL BY BREATHING VAPORS/DUSTS. MAY BE HARMFUL IF SWALLOWED. MAY BE HARMFUL BY SKIN CONTACT. MAY PRODUCE BIRTH DEFECTS IN THE DEVELOPING FETUS. MAY BE EXCRETED IN HUMAN MILK. MAY CAUSE HARM TO THE NURSING INFANT. CANCER AGENT! EXPOSURE MAY PRODUCE CANCER. CANCER AGENT BASED ON TESTS WITH LABORATORY ANIMALS. POSSIBLE CANCER AGENT BASED ON TESTS WITH LABORATORY ANIMALS. MAY PRODUCE ALLERGIC REACTION BY INGESTION/INHALATION/SKIN CONTACT. MAY PRODUCE NUMBNESS OR WEAKNESS IN THE EXTREMITIES. EXPOSURE MAY CAUSE (SPECIFY THE ORGAN(S)) DAMAGE. HEATING/COMBUSTION MAY CAUSE HAZARDOUS DECOMPOSITION PRODUCTS. (G) Precautionary Statements Keep out of reach of children. When using do not eat, drink, or smoke. Wash hands immediately after use. Avoid inhalation/ingestion/skin contact. Avoid fumes from combustion. Keep container tightly closed when not in use. Store in well-ventilated area. Wear protective clothing (specify type). Wear protective goggles/face shield. Wear NIOSH-certified mask for dusts/mists/fumes. Wear NIOSH-certified respirator with an appropriate cartridge for (specify). Wear NIOSH-certified supplied-air respirator. Use window exhaust fan to remove vapors and ensure adequate cross ventilation. (Specify explosion-proof if necessary.) Do not heat above (specify temperature) without adequate ventilation. Use (specify type) local exhausting hood. Do not use/mix with (specify material). (ii) The following shall apply with respect to the standard for art materials set forth in § 1500.14(b)(8)(i). (A) The term art material or art material product (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. ( 1 ( 2 ( 3 ( 4 (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. Appendix A to § 1500.14( b (a) The term “certifying organization,” as used in this paragraph, refers to an organization or an institute that, after assuring that all provisions are met, certifies that an art material does conform to the labeling requirements of this practice. (b) The certifying body may be funded by member manufacturers, but should include users or their representatives, as well as manufacturers' chemists, on its technical and certifying committees. (c) Representative samples of art materials, labeled as conforming to this section and bought at retail, should be analyzed at random and from time to time by an analytical laboratory to ensure they are the same as the formulation used by the toxicologist(s) for determining labeling requirements. (d) The methods used by the toxicologist(s) in review and determination of the need and content of precautionary labeling for potentially chronic adverse health effects should be periodically reviewed by an advisory board composed of not less than three or more than five toxicologists, at least one of whom is certified in toxicology by a nationally recognized certification board. (e) In cases where there is disagreement by participating producers or participating users, with the determination of the toxicologist(s), there should be a method whereby the toxicologist's decision can be presented to the advisory board of toxicologists for arbitration. [38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22934, June 8, 1976; 48 FR 16, Jan. 3, 1983; 53 FR 3018, Feb. 3, 1988; 57 FR 46669, Oct. 9, 1992; 60 FR 8193, Feb. 27, 1995; 61 FR 19829, May 3, 1996; 61 FR 33175, June 26, 1996] § 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. Note: The effective date of paragraphs (a)(6)(i)(A) and (a)(6)(ii)(A) was stayed by an order published in the Federal Register (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. General. (B) Voluntary standard. (C) Relationship of benefits to costs. (D) Least burdensome requirement. ( 1 ( 2 ( 3 ( 4 (12)(i) Large multiple-tube devices. (ii) Findings General. (B) Voluntary standard. 1 ( 2 (C) Relationship of benefits to costs. (D) Least burdensome requirement. (13)(i) Candles made with metal-cored wicks. (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. (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 General. (B) Voluntary standard. (C) Relationship of benefits to costs. (D) Least burdensome requirement. (b) [Reserved] (Secs. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74 Stat. 372, 374, as amended 80 Stat. 1304-05, 83 Stat. 187-189, 90 Stat. 503 (15 U.S.C. 1261, 1262); sec. 701 (e), (f), (g), 52 Stat. 1055-56, as amended 70 Stat. 919, 72 Stat. 948 (21 U.S.C. 371 (e), (f), (g)), sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a))) [38 FR 27012, Sept. 27, 1973, as amended at 38 FR 27514, Oct. 4, 1973; 38 FR 31520, Nov. 15, 1973; 39 FR 30114, Aug. 21, 1974; 39 FR 42903, Dec. 9, 1974; 41 FR 22935, June 8, 1976; 42 FR 44202, Sept. 1, 1977; 43 FR 12310, Mar. 24, 1978; 48 FR 16, Jan. 3, 1983; 56 FR 37837, Aug. 9, 1991; 61 FR 13095, Mar. 26, 1996; 61 FR 18245, Apr. 25, 1996; 68 FR 19147, Apr. 18, 2003] § 1500.18 Banned toys and other banned articles intended for use by children. Link to an amendment published at 91 FR 45998, July 22, 2026. (a) Toys and other articles presenting mechanical hazards. (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 (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 General. (B) Voluntary standard. (C) Relationship of benefits to costs. (D) Least burdensome requirement. (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 (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. (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. (B) Voluntary standard. (C) Relationship of benefits to costs. (D) Least burdensome requirement. (b) Electrically operated toys and other electrical operated children's articles presenting electrical, thermal, and/or 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. Note: Paragraph (b)(1) was originally promulgated as 21 CFR 191.9a(b)(1) with an effective date of September 3, 1973 (38 FR 6138). (2) [Reserved] (c) Toys and other articles (not electrically operated) presenting electric hazards. (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] (15 U.S.C. 1261 (f)(1)(D), (g)(1)(A), (r); 15 U.S.C. 1262(e)(1); 15 U.S.C. 2079(a)) [38 FR 27012, Sept. 27, 1973] Editorial Note: For Federal Register www.govinfo.gov. § 1500.19 Misbranded toys and other articles intended for use by children. (a) Definitions. (1) Ball (2) Small ball 1/4 (3) Latex balloon (4) Marble (5) Small part (6) Package (7) Descriptive material (8) Bin container for retail display (b) Misbranded toys and children's articles. (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. (d) Prominence and conspicuousness of labeling statements. (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. Area sq. in 0-2 + 2-5 + 5-10 + 10-15 + 15-30 + 30-100 + 100-400 + 400 Type Size Sig. Wd 3 64 1 16 3 32 7 64 1 8 5 32 1 4 1 2 St. Haz 3 64 3 64 1 16 3 32 3 32 7 64 5 32 1 4 Oth. Mat 1 32 3 64 1 16 1 16 5 64 3 32 7 64 5 32 (8) Labeling required by this section that appears on a bin, container for retail display, or vending machine shall be in reasonable proximity to any pricing or product information contained on the principal display panel, or, if such information is not present, in close proximity to the article that is subject to the labeling requirements. (9) Descriptive material that accompanies a product subject to the labeling requirements, including accompanying material subject to the alternative allowed by § 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. (f) Alternative labeling statements for small packages. (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: and bears an arrow or other indicator pointing toward or directing the purchaser's attention to the display panel on the package where the full labeling statement appears, or (ii) In the case of a balloon subject to § 1500.19(b)(2) or a toy or game containing such a balloon, the principal display panel bears the statement: and bears an arrow or other indicator pointing toward or directing the purchaser's attention to the display panel on the package where the full labeling statement appears. (g) Alternative for products manufactured outside the United States. (h) Preemption. [60 FR 10752, Feb. 27, 1995, as amended at 60 FR 41802, Aug. 14, 1995] § 1500.20 Labeling requirement for advertising toys and games. (a) Scope. (b) Effective Date. (c) Definitions. (1) Ball (2) Small ball 1/4 (3) Latex balloon (4) Marble (5) Small part (6) Direct means of purchase or order (d) Advertising requirements. (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. (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: Required cautionary statement Number 16 CFR 1500.19(b)(1) 1 1 16 CFR 1500.19(b)(2) 2 2 16 CFR 1500.19(b)(3)(i) 3 3 16 CFR 1500.19(b)(3)(ii) 4 4 16 CFR 1500.19(b)(4)(i) 5 5 16 CFR 1500.19(b)(4)(ii) 6 6 1 2 3 4 5 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. (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. (h) Business to Business Catalogue Exception. [73 FR 67736, Nov. 17, 2008, as amended at 73 FR 71545, Nov. 25, 2008] § 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 in silico in vivo in vivo (a) Acute dermal toxicity single exposure Dimensions of Sleeves for Acute Dermal Toxicity Test [Test animal—Rabbits] Measurements in centimeters Range of weight of animals (grams) Average area of exposure (square centimeters) Average percentage of total body surface Diameter at ends Overall length 7.0 12.5 2,500-3,500 240 10.7 (b) Preparation of test animal. (c) Procedures for testing. [38 FR 27012, Sept. 27, 1973, as amended at 77 FR 73294, Dec. 10, 2012; 83 FR 8342, Feb. 27, 2018] § 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 in vivo in vivo Skin reaction Value 1 Erythema and eschar formation: No erythema 0 Very slight erythema (barely perceptible) 1 Well-defined erythema 2 Moderate to severe erythema 3 Severe erythema (beet redness) to slight eschar formations (injuries in depth) 4 Edema formation: No edema 0 Very slight edema (barely perceptible) 1 Slight edema (edges of area well defined by definite raising) 2 Moderate edema (raised approximately 1 millimeter) 3 Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) 4 1 Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skin at 24 hours and 72 hours, as described in this paragraph. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Similarly, add the values for edema formation at 24 hours and at 72 hours for intact and abraded skin (four values). The total of the eight values is divided by four to give the primary irritation score; for example: Skin reaction Exposure time (hours) Evaluation value Erythema and eschar formation: Intact skin 24 2 Do 72 1 Abraded skin 24 3 Do 72 2 Subtotal 8 Edema formation: Intact skin 24 0 Do 72 1 Abraded skin 24 1 Do 72 2 Subtotal 4 Total 12 Thus, the primary irritation score is 12 ÷ 4 = 3. [38 FR 27012, Sept. 27, 1973, as amended at 77 FR 73294, Dec. 10, 2012] § 1500.42 Test for eye irritants. Guidelines for in vivo in vitro in vitro in vivo in vivo (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 1 2 1 http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/EPA/EPA_870_2400.pdf 2 http://iccvam.niehs.nih.gov/SuppDocs/FedDocs/OECD/OECDtg405.pdf [38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973; 62 FR 46667, Sept. 4, 1997; 77 FR 73294, Dec. 10, 2012] § 1500.43 Method of test for flashpoint of volatile flammable materials by Tagliabue open-cup apparatus. Scope 1. (a) This method describes a test procedure for the determination of open-cup flashpoints of volatile flammable materials having flashpoints below 175 °F. (b) This method, when applied to paints and resin solutions which tend to skin over or which are very viscous, gives less reproducible results than when applied to solvents. Outline of Method 2. The sample is placed in the cup of a Tag Open Tester, and heated at a slow but constant rate. A small test flame is passed at a uniform rate across the cup at specified intervals. The flashpoint is taken as the lowest temperature at which application of the test flame causes the vapor at the surface of the liquid to flash, that is, ignite but not continue to burn. Apparatus 3. The Tag open-cup tester is illustrated in Fig. 1. It consists of the following parts, which must conform to the dimensions shown, and have the additional characteristics as noted: (a) Copper bath, 1/8 (b) Thermometer holder. (c) Thermometer. (d) Glass test cup. (e) Leveling device. 1/8 (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 1/2 1/2 5/8 (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. Procedure 4. (a) Place the tester on a solid table free of vibration, in a location free of perceptible draft, and in a dim light. (b) Run water, brine, or water-glycol solution into the bath to a predetermined level, which will fill the bath to 1/8 (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 (d) Fill the glass cup with the sample liquid to a depth just 1/8 (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 (g) Light the ignition flame and adjust it to form a flame of spherical form matching in size the 5/52 (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. Initial Test 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. Recorded Tests 6. Repeat the procedure by cooling a fresh portion of the sample, the glass cup, the bath solution, and the thermometer at least 20 °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. Reporting Data 7. The average of not less than three recorded tests, other than the initial test, shall be used in determining the flashpoint and flammability of the substance. Standardization 8. (a) Make determinations in triplicate on the flashpoint of standard paraxylene and of standard isopropyl alcohol which meet the following specifications: (i) Specifications for p-xylene, flashpoint check grade. p-xylene shall conform to the following requirements; Specific gravity: 15.56 °C./15.56 °C., 0.860 minimum, 0.866 maximum Boiling range: 2 °C. maximum from start to dry point when tested in accordance with the method of test for distillation of industrial aromatic hydrocarbons (ASTM designation: D 850), or the method of test for distillation range of lacquer solvents and diluents (ASTM) designation D 1078). The range shall include the boiling point of pure P Purity: 95 percent minimum, calculated in accordance with the method of test for determination of purity from freezing points of high-purity compounds (ASTM designation: D 1016), from the experimentally determined freezing point, measured by the method of test for measurement of freezing points of high-purity compounds for evaluation of purity (ASTM designation: D 1015). (ii) Specifications for ispropanol, flash point check grade. Specific gravity: 0.8175 to 0.8185 at 20 °C./20 °C. as determined by means of a calibrated pycnometer. Distillation range: Shall entirely distill within a 1.0 °C. range which shall include the temperature 80.4 °C. as determined by ASTM method D 1078. Average these values for each compound. If the difference between the values for these two compounds is less than 15 °F. (8.5 °C.) or more than 27 °F. (16 °C.), repeat the determinations or obtain fresh standards. (b) Calculate a correction factor as follows: X Y Correction = ( X Y Where: A = Observed flash of p- B = Observed flash of isopropyl alcohol. Apply this correction of all determinations. Half units in correction shall be discarded. Precision 9. (a) For hydrocarbon solvents having flashpoints between 60 °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). Note: 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. [51 FR 28537, Aug. 8, 1986] § 1500.43a Method of test for flashpoint of volatile flammable materials. (a) Scope. 1 1 (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. (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. (d) Test apparatus. (e) Safety precautions. (f) Preparation of samples. (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. (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. Turn the temperature control knob 2 3 2 3 (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. (i) Target flashpoint, °C = S c (ii) Target flashpoint, °C = S c (iii) Target flashpoint, °F = S f where: S c S f B = ambient barometric pressure, mm Hg, 4 4 A = ambient barometer pressure, kPa. 4 (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 5 (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 6 (4) Charge the syringe with a 2-ml specimen of the sample 7 7 (5)(i) Set the timer 8 8 (ii) After the time signal indicates the specimen is at test temperature 8 1/2 9 9 (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. (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 (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 7 (ii) Set the timer 10 5/32 (iii) After the audible time signal indicates the specimen is at test temperature, 10 1/2 10 (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 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. 4 (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) Where: F = Observed flashpoint, °F, C = observed flashpoint, °C, B = ambient barometric pressure, mm Hg; and A = ambient barometric pressure, kPa. (l) Precision. (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. (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. (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 Material p A B Specific gravity. 15.6/15.6 °C (60/60 °F) 0.850 to 0.866. Boiling range 2 °C maximum including 138.35 °C (281.03 °F). Freezing point 11.23 °C (52.2 °F) minimum. Flashpoint °C (acceptable range) 25.6 ±0.5 (78 ±1 Φ). A B Table 2—Repeatability and Reproducibility Temperature, °C (°F) Repeatability, °C (°F) Reproducibility, °C (°F) 20(68) 0.5(0.9) 1.4(2.6) 70(158) 0.5(0.9) 2.9(5.3) 93(200) 1.3(2.3) 4.9(8.8) 150(300) 2.0(3.6) 7.5(13.5) 200(400) 2.6(4.7) 9.9(17.9) 260(500) 3.3(5.9) 12.4(22.3) Table 3—Essential Dimensions of Flash Test Apparatus A B Sample Block Block diameter 61.5-62.5 Sample well diameter 49.40-49.70 Sample well depth 9.70-10.00 Top of block to center of thermometer hole 16.00-17.00 Diameter of thermometer hole (approx.) 7.0004 Cover Large opening length 12.42-12.47 Large opening width 10.13-10.18 Small opening length 5.05-5.10 Small opening width 7.60-7.65 Distance between extreme edges of small openings 48.37-48.32 Filling orifice diameter 4.00-4.50 Bore or filler tube 1.80-1.85 Maximum distance of filler tube from base of well with cover closed (max.) 0.75 Slide Large opening length 12.42-12.47 Large opening width 10.13-10.18 Small opening length 5.05-5.10 Small opening width 7.60-7.65 Near edge of large opening to end of slide 12.80-12.85 Extremes of large and small openings 30.40-30.45 Jet Length of jet 18.30-18.40 External diameter at end of jet 2.20-2.60 Bore of jet 1.60-1.65 Height of jet center above top surface of cover 11.00-11.20 Jet pivot to center of block with cover closed 12.68-12.72 A B [51 FR 28539, Aug. 8, 1986] § 1500.44 Method for determining extremely flammable and flammable solids. (a) Preparation of samples Granules, powders, and pastes. (2) Rigid and pliable solids. (b) Procedure. 2 § 1500.45 Method for determining extremely flammable and flammable contents of self-pressurized containers. (a) Equipment required. (b) Procedure. § 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. [51 FR 28544, Aug. 8, 1986] § 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. (b) Scope General. (2) Exemptions. (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, (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 General. (2) Accessible points. (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. (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. (d) Sharp point test method Principle of operation. (2) Procedure. (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. § 1500.49 Technical requirements for determining a sharp metal or glass edge in toys and other articles intended for use by children under 8 years of age. (a) Objective. (b) Scope General. (2) Exemptions. (ii) Toys that by reason of their functional purpose necessarily present the hazard of sharp metal or glass edges and that do not have any nonfunctional sharp metal or glass edges are exempt from this section: Provided, the toy is identified by a conspicuous, legible, and visible label at the time of any sale, as having functional sharp metal or glass edges. Examples of these are a pair of toy scissors and toy tool kits. (iii) Articles, besides toys, intended for use by children that by reason of their functional purpose necessarily present the hazard of sharp metal or glass edges and that do not have any non-functional sharp metal or glass edges are exempt from this section. Examples of these are children's ice skates and children's cutlery. (3) Definitions Glass. (ii) Metal. (c) Accessibility General. (2) Accessible edges. (ii) An accessible edge for a toy or article intended for children over 3 years and up to 8 years of age is one that can be contacted by any portion forward of the collar of the accessibility probe designated as Probe B in Figure 2 of this section. (iii) An accessible edge for a toy or article intended for children of ages spanning both age groups is one that can be contacted by any portion forward of the collar of either Probe A or Probe B, as shown in Figure 2 of this section. (3) Insertion depth. (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 2 1/4 (iii) For any hole, recess, or opening having a minor dimension of 7.36 inches (186.9 millimeters) or larger when Probe A is used, or a minor dimension of 9.00 inches (228.6 millimeters) or larger when Probe B is used, the total insertion depth for accessibility is unrestricted unless other holes, recesses, or openings within the original hole, recess, or opening are encountered with dimensions specified in paragraph (c)(3) (i) or (ii) of this section. In such instances, the appropriate paragraphs (c)(3) (i) or (ii) of this section shall be followed. If both probes are to be used, a minor dimension that is 7.36 inches (186.9 millimeters or larger shall determine unrestricted access. (4) Inaccessible edges. (d) Sharp edge test method Principle of operation. 1/2 (2) Procedure. (ii) Part of the test sample may need to be removed to allow the sharp edge testing device to test an edge that is accessible by the criteria of paragraph (c) of this section. Such dismantling of the test sample could affect the rigidity of the edge in question. The sharp edge test shall be performed with the edge supported so that its stiffness approximates but is not greater than the edge stiffness in the assembled sample. (iii) Conduct of a sharp edge test is as follows: Wrap one layer of polytetrafluoroethylene (TFE) tape, described in paragraph (e)(3) of this section, around the full circumference of the mandrel in an unstretched state. The ends of the tape shall be either butted or overlapped not more than 0.10 inch (2.5 millimeters). Apply the mandrel, at the approximate center of the tape, to the edge of the test sample with a force of 1.35 pounds (6.00 Newtons) measured in a direction at right angles to the mandrel axis. The mandrel shall be placed so that its axis is at 90 degrees ±5 degrees to the line of a straight test edge or 90 degrees ±5 degrees to a tangent at the point of contact with a curved test edge. The point of contact between the test edge and the mandrel shall be in the approximate center of the width of the tape. The axis of the mandrel may be positioned anywhere in a plane which is at right angles to either the line of a straight test edge or to a tangent at the point of contact with a curved test edge. The operator should seek the orientation most likely to cause the edge to cut the tape. Maintain the force against the edge and rotate the mandrel through one complete revolution while preventing any linear motion of the mandrel along the edge. Release the mandrel from the edge and remove the tape without enlarging any cut or causing any score to become a cut. A cut in the tape with a length of not less than 1/2 (e) Specifications for sharp edge test equipment. (1) The rotation of the mandrel shall produce a constant tangential velocity of 1.00±0.08 inch per second (25.4±2.0 millimeters per second) during the center 75 percent of its rotation and shall have a smooth start and stop. (2) The mandrel shall be made of steel. The test surface of the mandrel shall be free of scratches, nicks, or burrs and shall have a surface roughness no greater than 16 microinches (0.40 micron). The test surface shall have a hardness no less than 40 as measured on the Rockwell “C” scale, as determined pursuant to ASTM E 18-74 entitled “Standard Test Methods for Rockwell Hardness and Rockwell Superficial Hardness of Metallic Materials,” published July 1974 and which is incorporated by reference in this regulation. (Copies are available from American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103.) The diameter of the mandrel shall be 0.375±0.005 inch (9.35±0.12 millimeters). The mandrel shall be of suitable length to carry out the test. (3) The tape shall be pressure-sensitive polytetrafluoroethylene (TFE) high temperature electrical insulation tape as described in Military Specification MIL-I-23594B (1971) which is incorporated by reference in this regulation. (Copies are available from Naval Publications and Forms Center, 5801 Tabor Ave., Philadelphia, Pa. 19120.) The thickness of the polytetrafluoroethylene backing shall be between 0.0026 inch (0.066 millimeter) and 0.0035 inch (0.089 millimeter). 1 1/4 1 (f) For the purpose of conformance with the technical requirements prescribed by this § 1500.49, the English figures shall be used. The metric approximations are provided in parentheses for convenience and information only. (Secs. 2(s), 10(a), 74 Stat. 378 (15 U.S.C. 1261, 1269)) [43 FR 12645, Mar. 24, 1978, as amended at 43 FR 21324, May 17, 1978] § 1500.50 Test methods for simulating use and abuse of toys and other articles intended for use by children. (a) Objective. (b) Application—general. (ii) The test methods described in §§ 1500.51, 1500.52, and 1500.53 have been established for articles intended for the specified age groups of children: 18 months of age or less, over 18 months but not over 36 months of age, and over 36 months but not over 96 months of age. If an article is marked, labeled, advertised, or otherwise intended for children of ages spanning more than one of these age groups, the article will be subjected to the tests providing the most stringent requirements. If an article is not age-labeled in a clear and conspicuous manner or, based on such factors as marketing practices and the customary patterns of usage of a product by children, is inappropriately age-labeled, and is intended or appropriate for children 96 months of age or less, it will also be subjected to the most stringent test requirements. (2) For purposes of compliance with the test methods prescribed in §§ 1500.51, 1500.52, and 1500.53, the English system shall be used. The metric approximations are provided in parentheses for convenience and information only. (3) Each of the test methods described in §§ 1500.51, 1500.52, and 1500.53 shall be applied to a previously untested sample except the tension test which shall be conducted with the test sample used in the torque test. (4) Prior to testing, each sample shall be subjected to a temperature of 73°±3 °F. (23°±2 °C.) as a relative humidity of 20−70 percent for a period of at least 4 hours. The toy testing shall commence within five minutes after the toy has been removed from the preconditioning atmosphere. (5) Toys reasonably intended to be assembled by an adult and not intended to be taken apart by a child shall be tested only in the assembled state if the shelf package and the assembly instructions prominently indicate that the article is to be assembled only by an adult. (6) Toys intended to be repeatedly assembled and taken apart shall have the individual pieces as well as the completed article subjected to these test procedures. (7) In situations where a test procedure may be applied in more than one way to a toy test component, the point (or direction) of force (or torque) application which results in the most severe conditions shall be used. (c) Definitions. (1) Toy (2) Mouth toy [40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. 10, 1975] § 1500.51 Test methods for simulating use and abuse of toys and other articles intended for use by children 18 months of age or less. (a) Application. (b) Impact test Application. (2) Impact medium. 1/8 1 1 (3) Testing procedure. (4) Large and bulky toys. (ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic meter), calculated by the major dimensions without regard to minor appendages, shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. (iii) The toys described in paragraph (b)(4)(i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section. (c) Bite test Application. (2) Test equipment Contact mechanism. (ii) Loading device. (3) Testing procedure. (d) Flexure test Application. (2) Testing procedure. (e) Torque test Application General. (ii) Toys with rotating components. (2) Test equipment Loading device. (ii) Clamp. (3) Testing procedure. (f) Tension test Application General. (ii) Stuffed toys and beanbags. (2) Test equipment Clamps. (ii) Loading device. (3) Testing procedure. (g) Compression test Application. (2) Test apparatus. 1/32 (3) Testing procedure. [40 FR 1484, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975; 40 FR 17746, Apr. 22, 1975, as amended at 55 FR 52040, Dec. 19, 1990; 56 FR 9, Jan. 2, 1991; 56 FR 558, Jan. 7, 1991] § 1500.52 Test methods for simulating use and abuse of toys and other articles intended for use by children over 18 but not over 36 months of age. (a) Application. (b) Impact test Application. (2) Impact medium. 1/8 1 1 (3) Testing procedure. (4) Large and bulky toys. (ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic meter), calculated by the major dimensions without regard to minor appendages, shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. (iii) The toys described in paragraph (b)(4) (i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section. (c) Bite test Application. (2) Test equipment Contact mechanism. (ii) Loading device. (3) Testing procedure. (d) Flexure test Application. (2) Testing procedure. (e) Torque test Application General. (ii) Toys with rotating components. (2) Test equipment Loading device. (ii) Clamp. (3) Testing procedure. (f) Tension test Application General. (ii) Stuffed toys and beanbags. (2) Test equipment Clamps. (ii) Loading device. (3) Testing procedure. (g) Compression test Application. (2) Test apparatus. 1/32 (3) Testing procedure. [40 FR 1485, Jan. 7, 1975; 40 FR 6210, Feb. 10, 1975; 40 FR 16192, Apr. 10, 1975, as amended at 56 FR 10, Jan. 2, 1991] § 1500.53 Test methods for simulating use and abuse of toys and other articles intended for use by children over 36 but not over 96 months of age. (a) Application. (b) Impact test Application. (2) Impact medium. 1/8 1 (3) Testing procedure. (4) Large and bulky toys. (ii) A toy that has a volume of more than 3 cubic feet (0.085 cubic meter), calculated by the major dimensions without regard to minor appendages, shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. (iii) The toys described in paragraph (b)(4) (i) and (ii) of this section shall be tested for impact by tipping them over three times by pushing the samples slowly past their centers of balance onto the impact medium described in paragraph (b)(2) of this section. (c) Bite test Application. (2) Test equipment Contact mechanism. (ii) Loading device. (3) Testing procedure. (d) Flexure test Application. (2) Testing procedure. (e) Torque test Application General. (ii) Toys with rotating components. (2) Test equipment Loading device. (ii) Clamp. (3) Testing procedure. (f) Tension test Application General. (ii) Stuffed toys and beanbags. (2) Test equipment Clamps. (ii) Loading device. (3) Testing procedure. (g) Compression test Application. (2) Test apparatus. 1/32 (3) Testing procedure. [40 FR 1486, Jan. 7, 1975; 40 FR 16192, Apr. 10, 1975, as amended at 56 FR 10, Jan. 2, 1991] § 1500.81 Exemptions for food, drugs, cosmetics, and fuels. (a) Food, drugs, and cosmetics. (b) Fuels. § 1500.82 Exemption from full labeling and other requirements. (a) Any person who believes a particular hazardous substance intended or packaged in a form suitable for use in the household or by children should be exempted from full label compliance otherwise applicable under the act, because of the size of the package or because of the minor hazard presented by the substance, or for other good and sufficient reason, may submit to the Commission a request for exemption under section 3(c) of the act, presenting facts in support of the view that full compliance is impracticable or is not necessary for the protection of the public health. The Commission shall determine on the basis of the facts submitted and all other available information whether the requested exemption is consistent with adequate protection of the public health and safety. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order published in the Federal Register. (b) The Commission may on its own initiative determine on the basis of facts available to it that a particular hazardous substance intended or packaged in a form suitable for use in the household or by children should be exempted from full labeling compliance otherwise applicable under the act because of the size of the package or because of the minor hazard presented by the substance or for other good and sufficient reason. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order in the Federal Register. (c) Any person who believes a particular article should be exempted from being classified as a “banned hazardous substance” as defined by section 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)), because its functional purpose requires inclusion of a hazardous substance, it bears labeling giving adequate directions and warnings for safe use, and it is intended for use by children who have attained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings, may submit to the Commission a request for exemption under section 2(q)(1)(B)(i) of the act (repeated in proviso ( 1 Federal Register. (d) On its own initiative, the Commission may determine on the basis of available facts that a particular banned hazardous substance should be exempted from section 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)), because its functional purpose requires inclusion of a hazardous substance, it bears labeling giving adequate directions and warnings for safe use, and it is intended for use by children who have obtained sufficient maturity, and may reasonably be expected, to read and heed such directions and warnings. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order in the Federal Register. § 1500.83 Exemptions for small packages, minor hazards, and special circumstances. (a) The following exemptions are granted for the labeling of hazardous substances under the provisions of § 1500.82: (1) When the sole hazard from a substance in a self-pressurized container is that it generates pressure or when the sole hazard from a substance is that it is flammable or extremely flammable, the name of the component which contributes the hazards need not be stated. (2) Common matches, including book matches, wooden matches, and so-called “safety” matches are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the product being considered hazardous because of being an “extremely flammable solid” or “flammable solid” as defined in § 1500.3(c)(6)(v) and (vi). (3) Paper items such as newspapers, wrapping papers, toilet and cleansing tissues, and paper writing supplies are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the products being considered hazardous because of being an “extremely flammable solid” or “flammable solid” as defined in § 1500.3(c)(6)(v) and (vi). (4) Thread, string, twine, rope, cord, and similar materials are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the products being considered hazardous because of being an “extremely flammable solid” or “flammable solid” as defined in Sec. 1500.3(c)(6)(v) and (vi). (5) Laboratory chemicals intended only for research or investigational and other laboratory uses (except those in home chemistry sets) are exempt from the requirements of placement provided in § 1500.121 if all information required by that section and the act appears with the required prominence on the label panel adjacent to the main panel. (6) [Reserved] (7) Rigid or semirigid ballpoint ink cartridges are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), insofar as such requirements would be necessary because the ink contained therein is a “toxic” substance as defined in § 1500.3(c)(2)(i), if: (i) The ballpoint ink cartridge is of such construction that the ink will, under any reasonably foreseeable conditions of manipulation or use, emerge only from the ballpoint end; (ii) When tested by the method described in § 1500.3(c)(2)(i), the ink does not have an LD-50 single oral dose of less than 500 milligrams per kilogram of body weight of the test animal; and (iii) The cartridge does not have a capacity of more than 2 grams of ink. (8) Containers of paste shoe waxes, paste auto waxes, and paste furniture and floor waxes containing toluene (also known as toluol), xylene (also known as xylol), petroleum distillates, and/or turpentine in the concentrations described in § 1500.14(a)(3) and (5) are exempt from the labeling requirements of § 1500.14(b)(3)(ii) and (5) if the visicosity of such products is sufficiently high so that they will not flow from their opened containers when inverted for 5 minutes at a temperature of 80 °F., and are exempt from bearing a flammability warning statement if the flammability of such waxes is due solely to the presence of solvents that have flashpoints above 80 °F. when tested by the method described in § 1500.43. (9) Porous-tip ink-marking devices are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and from the labeling requirements of § 1500.14(b)(1), (2), and (3)(ii) and (iii) insofar as such requirements would be necessary because the ink contained therein is a toxic substance as defined in § 1500.3(c)(2)(i), and/or because the ink contains 10 percent or more by weight of toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates as defined in § 1500.14(a)(3), and/or because the ink contains 10 percent or more by weight of ethylene glycol; provided that: (i) The porous-tip ink-marking devices are of such construction that: (A) The ink is held within the device by an absorbent material so that no free liquid is within the device; and (B) Under any reasonably foreseeable conditions of manipulation and use, including reasonably foreseeable abuse by children, the ink will emerge only through the porous writing nib of the device; and (ii)(A) The device has a capacity of not more than 10 grams of ink and the ink, when tested by methods described in § 1500.3(c)(2)(i), has an LD-50 single oral dose of not less than 2.5 grams per kilogram of body weight of the test animal; or (B) The device has a capacity of not more than 12 grams of ink and the ink, when tested by methods described in § 1500.3(c)(2)(i), has an LD-50 single oral dose of not less than 3.0 grams per kilogram of body weight of the test animal. (10) Viscous nitrocellulose-base adhesives containing more than 4 percent methyl alcohol by weight are exempt from the label statement “Cannot be be made nonpoisonous” required by § 1500.14(b)(4) if: (i) The total amount of methyl alcohol by weight in the product does not exceed 15 percent; and (ii) The contents of any container does not exceed 2 fluid ounces. (11) Packages containing polishing or cleaning products which consist of a carrier of solid particulate or fibrous composition and which contain toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates in the concentrations described in § 1500.14(a) (1) and (2) are exempt from the labeling requirements of § 1500.14(b)(3)(ii) if such toluene, xylene, or petroleum distillate is fully absorbed by the solid, semisolid, or fibrous carrier and cannot be expressed therefrom with any reasonably foreseeable conditions of manipulation. (12) Containers of dry ink intended to be used as a liquid ink after the addition of water are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and from the labeling requirements of § 1500.14(b) (1) and (2) insofar as such requirements would be necessary because the dried ink contained therein is a toxic substance as defined in § 1500.3(c)(2)(i) and/or because the ink contains 10 percent or more of ethylene glycol as defined in § 1500.14(a)(2); provided that: (i) When tested by the method described in § 1500.3(c)(2)(i), the dry ink concentrate does not have an LD-50 (lethal dose, median; lethal for 50 percent or more of test group) single oral dose of less than 1 gram per kilogram of body weight of the test animal. (ii) The dry ink concentrate enclosed in a single container does not weigh more than 75 milligrams. (iii) The dry ink concentrate does not contain over 15 percent by weight of ethylene glycol. (13) Containers of liquid and semisolid substances such as viscous-type paints, varnishes, lacquers, roof coatings, rubber vulcanizing preparations, floor covering adhesives, glazing compounds, and other viscous products containing toluene (also known as toluol), xylene (also known as xylol), or petroleum distillates in concentrations described in § 1500.14(a)(3) are exempt from the labeling requirements of § 1500.14(b)(3)(ii) insofar as that subdivision applies to such toluene, xylene, or petroleum distillates, provided that the viscosity of the substance or of any liquid that may separate or be present in the container is not less than 100 Saybolt universal seconds at 100 °F. (14) Customer-owned portable containers that are filled by retail vendors with gasoline, kerosene (kerosine), or other petroleum distillates are exempt from the provision of section 2(p)(1)(A) of the act (which requires that the name and place of business of the manufacturer, distributor, packer, or seller appear on the label of such containers) provided that all the other label statements required by section 2(p)(1) of the act and § 1500.14(b)(3) appear on the labels of containers of the substances named in this subparagraph. (15) Cellulose sponges are exempt from the labeling requirements of section 2(p)(1) of the act and § 1500.14(b)(1) insofar as such requirements would be necessary because they contain 10 percent or more of diethylene glycol as defined in § 1500.14(a)(1), provided that: (i) The cellulose sponge does not contain over 15 percent by weight of diethylene glycol; and (ii) The diethylene glycol content is completely held by the absorbent cellulose material so that no free liquid is within the sponge as marketed. (16) Containers of substances which include salt (sodium chloride) as a component are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements would be necessary because the salt contained therein is present in a quantity sufficient to render the article “toxic” as defined in § 1500.3(3)(2)(i), provided that the labels of such containers bear a conspicuous statement that the product contains salt. (17) The labeling of substances containing 10 percent or more of ferrous oxalate is exempt from the requirement of § 1500.129(f) that it bear the word “poison” which would be required for such concentration of a salt of oxalic acid. (18) Packages containing articles intended as single-use spot removers, and which consist of a cotton pad or other absorbent material saturated with a mixture of drycleaning solvents, are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as they apply to the “flammable solid” hazard as defined in § 1500.3(c)(6)(vi), provided that: (i) The article is packaged in a sealed foil envelope; (ii) The total amount of solvent in each package does not exceed 4.5 milliliters; and (iii) The article will ignite only when in contact with an open flame, and when so ignited, the article burns with a sooty flame. (19) Packages containing articles intended as single-use spot removers, and which consist of a cotton pad or other absorbent material containing methyl alcohol, are exempt from the labeling requirements of § 1500.14(b)(4), if: (i) The total amount of cleaning solvent in each package does not exceed 4.5 milliliters of which not more than 25 percent is methyl alcohol; and (ii) The liquid is completely held by the absorbent materials so that no free liquid is within the packages marketed. (20) Cigarette lighters containing petroleum distillate fuel are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and § 1500.14(b)(3) insofar as such requirements would be necessary because the petroleum distillate contained therein is flammable and because the substance is named in § 1500.14(a)(3) as requiring special labeling, provided that: (i) Such lighters contain not more than 10 cubic centimeters of fuel at the time of sale; and (ii) Such fuel is contained in a sealed compartment that cannot be opened without the deliberate removal of the flush-set, screw-type refill plug of the lighter. (21) Containers of dry granular fertilizers and dry granular plant foods are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements would be necessary because the fertilizer or plant food contained therein is a toxic substance as defined in § 1500.3(c)(2)(i), provided that: (i) When tested by the method described in § 1500.3(c)(2)(i), the product has a single dose LD-50 of not less than 3.0 grams per kilogram of body weight of the test animal; (ii) The label of any such exempt dry granular fertilizers discloses the identity of each of the hazardous ingredients; (iii) The label bears the name and address of the manufacturer, packer, distributor, or seller; and (iv) The label bears the statement “Keep out of the reach of children” or its practical equivalent. (22) Small plastic capsules containing a paste composed of powdered metal solder mixed with a liquid flux are exempt from the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if: (i) The capsule holds not more than one-half milliliter of the solder mixture; (ii) The capsule is sold only as a component of a kit; and (iii) Adequate caution statements appear on the carton of the kit and on any accompanying labeling which bears directions for use. (23) Chemistry sets and other science education sets intended primarily for use by juveniles, and replacement containers of chemicals for such sets, are exempt from the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if: (i) The immediate container of each chemical that is hazardous as defined in the act and regulations thereunder bears on its main panel the name of such chemical, the appropriate signal word for that chemical, and the additional statement “Read back panel before using” (or “Read side panel before using,” if appropriate) and bears on the back (or side) panel of the immediate container the remainder of the appropriate cautionary statement for the specific chemical in the container; (ii) The experiment manual or other instruction book or booklet accompanying such set bears on the front page thereof, as a preface to any written matter in it (or on the cover, if any there be), the following caution statement within the borders of a rectangle and in the type size specified in § 1500.121: WARNING—This set contains chemicals that may be harmful if misused. Read cautions on individual containers carefully. Not to be used by children except under adult supervision ; and (iii) The outer carton of such set bears on the main display panel within the borders of a rectangle, and in the type size specified in § 1500.121, the caution statement specified in paragraph (a)(23)(ii) of this section. (24) Fire extinguishers containing fire extinguishing agents which are stored under pressure or which develop pressure under normal conditions of use are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements apply to the pressure hazard as defined in § 1500.3(c)(7)(i), provided that: (i) If the container is under pressure both during storage and under conditions of use, it shall be designed to withstand a pressure of at least 6 times the charging pressure at 70 °F., except that carbon dioxide extinguishers shall be constructed and tested in accordance with applicable Interstate Commerce Commission specifications; or (ii) If the container is under pressure only during conditions of use, it shall be designed to withstand a pressure of not less than 5 times the maximum pressure developed under closed nozzle conditions at 70 °F. or 1 1/2 (25) Cleaning and spot removing kits intended for use in cleaning carpets, furniture, and other household objects; kits intended for use in coating, painting, antiquing, and similarly processing furniture, furnishings, equipment, sidings, and various other surfaces; and kits intended for use in photographic color processing are exempt from the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) and from the requirements of § 1500.14, provided that: (i) The immediate container of each hazardous substance in the kit is fully labeled and in conformance with the requirements of the act and regulations thereunder; and (ii) The carton of the kit bears on the main display panel (or panels) within a borderline, and in the type size specified in § 1500.121, the caution statement “(Insert proper signal word as specified in paragraph (a)(25)(iii) of this section). This kit contains the following chemicals that may be harmful if misused: (List hazardous chemical components by name.) Read cautions on individual containers carefully. Keep out of the reach of children.” (iii) If either the word “POISON” or “DANGER” is required on the container of any component of the kit, the same word shall be required to appear as part of the caution statement on the kit carton. If both “POISON” and “DANGER” are required in the labeling of any component or components in the kit, the word “POISON” shall be used. In all other cases the word “WARNING” or “CAUTION” shall be used. (26) Packages containing articles intended as single-use spot removers and containing methyl alcohol are exempt from the labeling specified in § 1500.14(b)(4), if: (i) The total amount of cleaning solvent in each unit does not exceed 1 milliliter, of which not more than 40 percent is methyl alcohol; (ii) The liquid is contained in a sealed glass ampoule enclosed in a plastic container with a firmly attached absorbent wick at one end through which the liquid from the crushed ampoule must pass, under the contemplated conditions of use; and (iii) The labeling of each package of the cleaner bears the statement “WARNING—Keep out of the reach of children,” or its practical equivalent, and the name and place of business of the manufacturer, packer, distributor, or seller. (27) Packaged fireworks assortments intended for retail distribution are exempt from section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if: (i) The package contains only fireworks devices suitable for use by the public and designed primarily to produce visible effects by combustion, except that small devices designed to produce audible effects may also be included if the audible effect is produced by a charge of not more than 2 grains of pyrotechnic composition; (ii) Each individual article in the assortment is fully labeled and in conformance with the requirements of the act and regulations thereunder; and (iii) The outer package bears on the main display panel (or panels), within the borders of a rectangle and in the type size specified in § 1500.121, the caution statement “WARNING—This assortment contains items that may be hazardous if misused and should be used only under adult supervision. IMPORTANT—Read cautions on individual items carefully.” (See also § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); § 1500.85(a)(2); and part 1507). (28) Packages containing felt pads impregnated with ethylene glycol are exempt from the labeling requirements of § 1500.14(b)(1), if: (i) The total amount of ethylene glycol in each pad does not exceed 1 gram; and (ii) The liquid is held by the felt pad so that no free ethylene glycol is within the package. (29) Cigarette lighters containing butane and/or isobutane fuel are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements would otherwise be necessary because the fuel therein is extremely flammable and under pressure, provided that: (i) The lighters contain not more than 12 grams of fuel at the time of sale; and (ii) The fuel reservoir is designed to withstand a pressure of at least 1 1/2 (30) The outer retail containers of solder kits each consisting of a small tube of flux partially surrounded by a winding of wire-type cadmium-free silver solder are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)), if: (i) The metal solder contains no cadmium and is not otherwise hazardous under the provisions of the act; (ii) The tube of flux in the kit is fully labeled and in conformance with the act and regulations thereunder, and any accompanying literature that bears directions for use also bears all the information required by section 2(p) of the act; and (iii) The main panel of the outer container bears in type size specified in § 1500.121 the following: (A) The signal word; (B) a statement of principal hazard or hazards; (C) the statement “Keep out of the reach of children,” or its practical equivalent; and (D) instructions to read other cautionary instructions on the tube of flux within. (31) Visual novelty devices consisting of sealed units, each of which unit is a steel and glass cell containing perchloroethylene (among other things), are exempt from the requirements of § 1500.121(a) that would otherwise require a portion of the warning statement to appear on the glass face of the device, provided that: (i) The device contains not more than 105 milliliters of perchloroethylene and contains no other component that contributes substantially to the hazard; and (ii) The following cautionary statement appears on the device (other than on the bottom) in the type size specified in § 1500.121 (c) and (d): Caution—If Broken, Resultant Vapors May Be Harmful Contains perchloroethylene. Do not expose to extreme heat. If broken indoors, open windows and doors until all odor of chemical is gone. Keep out of the reach of children. A practical equivalent may be substituted for the statement “Keep out of the reach of children.” (32) Hollow plastic toys containing mineral oil are exempt from the labeling specified in § 1500.14(b)(3)(ii), if: (i) The article contains no other ingredient that would cause it to possess the aspiration hazard specified in § 1500.14(b)(3)(ii); (ii) The article contains not more than 6 fluid ounces of mineral oil; (iii) The mineral oil has a viscosity of at least 70 Saybolt universal seconds at 100 °F.; (iv) The mineral oil meets the specifications in the N.F. for light liquid petrolatum; and (v) The container bears the statement “CAUTION—Contains light liquid petrolatum N.F. Discard if broken or leak develops.” (33) Containers of mineral oil having a capacity of not more than 1 fluid ounce and intended for use in producing a smoke effect for toy trains are exempt from the labeling specified in § 1500.14(b)(3), if: (i) The mineral oil meets the specifications in the N.F. for light liquid petrolatum; (ii) The mineral oil has a viscosity of at least 130 Saybolt universal seconds at 100 °F.; (iii) The article contains no other ingredient that contributes to the hazard; and (iv) The label declares the presence light liquid petrolatum and the name and place of business of the manufacturer, packer, distributor, or seller. (34) Viscous products containing more than 4 percent by weight of methyl alcohol, such as adhesives, asphalt-base roof and tank coatings, and similar products, are exempt from bearing the special labeling required by § 1500.14(b)(4), if: (i) The product contains not more than 15 percent by weight of methyl alcohol; (ii) The methyl alcohol does not separate from the other ingredients upon standing or through any foreseeable use or manipulation; (iii) The viscosity of the product is not less than 7,000 centipoises at 77 °F., unless the product is packaged in a pressurized container and is dispensed as a liquid unsuitable for drinking; and (iv) The labeling bears the statement “Contains methyl alcohol. Use only in well-ventilated area. Keep out of the reach of children.” (35) Individual detonators or blasting caps are exempt from bearing the statement, “Keep out of the reach of children,” or its practical equivalent, if: (i) Each detonator or cap bears conspicuously in the largest type size practicable the statement, “DANGEROUS—BLASTING CAPS—EXPLOSIVE” or “DANGEROUS—DETONATOR—EXPLOSIVE”; and (ii) The outer carton and any accompanying printed matter bear appropriate, complete cautionary labeling. (36) Individual toy rocket propellant devices and separate delay train and/or recovery system activation devices intended for use with premanufactured model rocket engines are exempt from bearing the full labeling required by section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) insofar as such requirements would be necessary because the articles are flammable or generate pressure, provided that: (i) The devices are designed and constructed in accordance with the specifications in § 1500.85(a)(8), (9) or (14); (ii) Each individual device or retail package of devices bears the following: (A) The statement “WARNING—FLAMMABLE: Read instructions before use”; (B) The common or usual name of the article; (C) A statement of the type of engine and use classification; (D) Instructions for safe disposal; and (E) Name and place of business of manufacturer or distributor; and (iii) Each individual rocket engine or retail package of rocket engines distributed to users is accompanied by an instruction sheet bearing complete cautionary labeling and instructions for safe use and handling of the individual rocket engines. (37) Glues with a cyanoacrylate base in packages containing 3 grams or less are exempt from the requirement of § 1500.121(d) that labeling which is permitted to appear elsewhere than on the main label panel must be in type size no smaller than 6 point type, provided that: (i) The main panel of the immediate container bears both the proper signal word and a statement of the principal hazard or hazards associated with this product, as provided by § 1500.121 (a) and (c); (ii) The main panel of the immediate container also bears an instruction to read carefully additional warnings elsewhere on the label and on any outer package, accompanying leaflet, and display card. The instruction to read additional warnings must comply with the size, placement, conspicuousness, and contrast requirements of § 1500.121; and (iii) The remainder of the cautionary labeling required by the act that is not on the main label panel must appear elsewhere on the label in legible type and must appear on any outer package, accompanying leaflet, and display card. If there is no outer package, accompanying leaflet, or display card, then the remainder of the required cautionary labeling must be displayed on a tag or other suitable material that is securely affixed to the article so that the labeling will remain attached throughout the conditions of merchandising and distribution to the ultimate consumer. That labeling which must appear on any outer package, accompanying leaflet, tag, or other suitable material must comply with the size, placement, contrast, and conspicuousness requirements of § 1500.121(d). (38) Rigid or semi-rigid writing instruments and ink cartridges having a writing point and an ink reservoir are exempt from the labeling requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i) of the regulations) and of regulations issued under section 3(b) of the act (§ 1500.14(b)(1, 2)) insofar as such requirements would be necessary because the ink contained therein is a “toxic” substance as defined in § 1500.3(c)(2)(i) and/or because the ink contains 10 percent or more by weight ethylene glycol or diethylene glycol, if all the following conditions are met: (i) The writing instrument or cartridge is of such construction that the ink will, under any reasonably foreseeable condition of manipulation and use, emerge only from the writing tip. (ii) When tested by the method described in § 1500.3(c)(2)(i), the ink does not have an LD-50 single oral dose of less than 2.5 grams per kilogram of body weight of the test animal. (iii) If the ink contains ethylene glycol or diethylene glycol, the amount of such substance, either singly or in combination, does not exceed 1 gram per writing instrument or cartridge. (iv) The amount of ink in the writing instrument or cartridge does not exceed 3 grams. [38 FR 27012, Sept. 27, 1973; 42 FR 33026, June 29, 1977, as amended at 43 FR 32745, July 28, 1978; 43 FR 47176, Oct. 13, 1978; 44 FR 42678, July 20, 1979; 46 FR 11513, Feb. 9, 1981; 48 FR 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, 2003; 74 FR 27249, June 9, 2009; 75 FR 49380, Aug. 13, 2010] § 1500.85 Exemptions from classification as banned hazardous substances. (a) The term banned hazardous substances (1) Chemistry sets and other science education sets intended primarily for juveniles, and replacement components for such sets, when labeled in accordance with § 1500.83(a)(23). (2) Firecrackers designed to produce audible effects, if the audible effect is produced by a charge of not more than 50 milligrams (.772 grains) of pyrotechnic composition. (See also § 1500.14(b)(7); § 1500.17(a) (3), (8) and (9); and part 1507). (3) [Reserved] (4) Educational materials such as art materials, preserved biological specimens, laboratory chemicals, and other articles intended and used for educational purposes. (5) Liquid fuels containing more than 4 percent by weight of methyl alcohol that are intended and used for operation of miniature engines for model airplanes, boats, cars, etc. (6) Novelties consisting of a mixture of polyvinyl acetate, U.S. Certified Colors, and not more than 25 percent by weight of acetone, and intended for blowing plastic balloons. (7) Games containing, as the sole hazardous component, a self-pressurized container of soap solution or similar foam-generating mixture provided that the foam-generating component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices: (i) Are designed to be ignited by electrical means. (ii) Contain no more than 62.5 grams (2.2 ounces) of propellant material and produce less than 80 newton-seconds (17.92 pound seconds) of total impulse with thrust duration not less than 0.050 second. (iii) Are constructed such that all the chemical ingredients are preloaded into a cylindrical paper or similarly constructed nonmetallic tube that will not fragment into sharp, hard pieces. (iv) Are designed so that they will not burst under normal conditions of use, are incapable of spontaneous ignition, and do not contain any type of explosive or pyrotechnic warhead other than a small parachute or recovery-system activation charge. (9) Separate delay train and/or recovery system activation devices intended for use with premanufactured model rocket engines wherein all of the chemical ingredients are preloaded so the user does not handle any chemical ingredient and are so designed that the main casing or container does not rupture during operation. (10) Solid fuel pellets intended for use in miniature jet engines for propelling model jet airplanes, speed boats, racing cars, and similar models, provided such solid fuel pellets: (i) Weigh not more than 11.5 grams each. (ii) Are coated with a protective resinous film. (iii) Contain not more than 35 percent potassium dichromate. (iv) Produce a maximum thrust of not more than 7 1/2 (v) Burn not longer than 12 seconds each when used as directed. (11) Fuses intended for igniting fuel pellets exempt under subparagraph (10) of this paragraph. (12) Kits intended for construction of model rockets and jet propelled model airplanes requiring the use of difluorodichloromethane as a propellant, provided the outer carton bears on the main panel in conspicuous type size the statement “WARNING—Carefully read instructions and cautions before use.” (13) Flammable wire materials intended for electro-mechanical actuation and release devices for model kits described in paragraph (12) of this section, provided each wire does not exceed 15 milligrams in weight. (14) Model rocket propellant devices (model rocket motors) designed to propel rocket-powered model cars, provided— (i) Such devices: (A) Are designed to be ignited electrically and are intended to be operated from a minimum distance of 15 feet (4.6 m) away; (B) Contain no more than 4 g. of propellant material and produce no more than 2.5 Newton-seconds of total impulse with a thrust duration not less than 0.050 seconds; (C) Are constructed such that all the chemical ingredients are pre-loaded into a cylindrical paper or similarly constructed non-metallic tube that will not fragment into sharp, hard pieces; (D) Are designed so that they will not burst under normal conditions of use, are incapable of spontaneous ignition, and do not contain any type of explosive or pyrotechnic warhead other than a small recovery system activation charge; (E) Bear labeling, including labeling that the devices are intended for use by persons age 12 and older, and include instructions providing adequate warnings and instructions for safe use; and (F) Comply with the requirements of 16 CFR 1500.83(a)(36)(ii and iii); and (ii) The surface vehicles intended for use with such devices: (A) Are lightweight, weighing no more than 3.0 oz. (85 grams), and constructed mainly of materials such as balsa wood or plastics that will not fragment into sharp, hard pieces; (B) Are designed to utilize a braking system such as a parachute or shock absorbing stopping mechanism; (C) Are designed so that they cannot accept propellant devices measuring larger than 0.5″ (13 mm) in diameter and 1.75″ (44 mm) in length; (D) Are designed so that the engine mount is permanently attached by the manufacturer to a track or track line that controls the vehicle's direction for the duration of its movement; (E) Are not designed to carry any type of explosive or pyrotechnic material other than the model rocket motor used for primary propulsion; (F) Bear labeling and include instructions providing adequate warnings and instructions for safe use; and (G) Are designed to operate on a track or line that controls the vehicles' direction for the duration of their movement and either cannot operate off the track or line or, if operated off the track or line, are unstable and fail to operate in a guided fashion so that they will not strike the operator or bystanders. (b) [Reserved] [38 FR 27012, Sept. 27, 1973, as amended at 41 FR 22935, June 8, 1976; 42 FR 43391, Aug. 29, 1977; 48 FR 16, Jan. 3, 1983; 68 FR 4699, Jan. 30, 2003] § 1500.86 Exemptions from classification as a banned toy or other banned article for use by children. Link to an amendment published at 91 FR 45998, July 22, 2026. (a) The term banned hazardous substance (1) Toy rattles described in § 1500.18(a)(1) in which the rigid wires, sharp protrusions, or loose small objects are internal and provided that such rattles are constructed so that they will not break or deform to expose or release the contents either in normal use or when subjected to reasonably foreseeable damage or abuse. (2) Dolls and stuffed animals and other similar toys described in § 1500.18(a)(3) in which the components that have the potential for causing laceration, puncture wound injury, or other similar injury are internal, provided such dolls, stuffed animals, and other similar toys are constructed so that they will not break or deform to expose such components either in normal use or when subjected to reasonably foreseeable damage or abuse. (3) [Reserved] (4) Any article known as a “baby-bouncer” or “walker-jumper” and any other similar article (referred to in this paragraph as “article(s)”), except an infant walker subject to part 1216 of this chapter, described in § 1500.18(a)(6) provided: (i) The frames are designed and constructed in a manner to prevent injury from any scissoring, shearing, or pinching when the members of the frame or other components rotate about a common axis or fastening point or otherwise move relative to one another; and (ii) Any coil springs which expand when the article is subjected to a force that will extend the spring to its maximum distance so that a space between successive coils is greater than one-eighth inch (0.125 inch) are covered or otherwise designed to prevent injuries; and (iii) All holes larger than one-eighth inch (0.125 inch) in diameter and slots, cracks, or hinged components in any portion of the article through which a child could insert, in whole or in part a finger, toe, or any other part of the anatomy are guarded or otherwise designed to prevent injuries; and (iv) The articles are designed and constructed to prevent accidental collapse while in use; and (v) The articles are designed and constructed in a manner that eliminates from any portion of the article the possibility of presenting a mechanical hazard through pinching, bruising, lacerating, crushing, breaking, amputating, or otherwise injuring portions of the human body when in normal use or when subjected to reasonably foreseeable damage or abuse; and (vi) Any article which is introduced into interstate commerce after the effective date of this subparagraph is labeled: (A) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller; and (B) With a code mark on the article itself and on the package containing the article or on the shipping container, in addition to the invoice(s) or shipping document(s), which code mark will permit future identification by the manufacturer of any given model (the manufacturer shall change the model number whenever the article undergoes a significant structural or design modification); and (vii) The manufacturer or importer of the article shall make, keep, and maintain for 3 years records of sale, distribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available at all reasonable hours upon request by any officer or employee of the Consumer Product Safety Commission and shall permit such officer or employee to inspect and copy such records, to make such stock inventories as he deems necessary, and to otherwise check the correctness of such records. (5) Clacker balls described in § 1500.18(a)(7) that have been designed, manufactured, assembled, labeled, and tested in accordance with the following requirements, and when tested at the point of production or while in interstate commerce or while held for sale after shipment in interstate commerce do not exceed the failure rate requirements of the table in paragraph (a)(5)(vi) of this section: (i) The toy shall be so designed and fabricated that: (A) Each ball: Weighs less than 50 grams; will not shatter, crack, or chip; is free of cracks, flash (ridges due to imperfect molding), and crazing (tiny surface cracks); and is free of rough or sharp edges around any hole where the cord enters or over any surface with which the cord may make contact. Each ball is free of internal voids (holes, cavities, or air bubbles) if the balls are made of materials other than those materials (such as ABS (acrylonitrile butadiene styrene), nylon, and high-impact polystyrene) that are injection-molded and possess high-impact characteristics. (B) The cord: Is of high tensile strength, synthetic fibers that are braided or woven, having a breaking strength in excess of 445 Newtons (100 pounds); is free of fraying or any other defect that might tend to reduce its strength in use; is not molded in balls made of casting resins which tend to wick up or run up on the outside of the cord; and is affixed to a ball at the center of the horizontal plane of the ball when it is suspended by the cord. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have a minimum cord breaking strength of less than 445 Newtons (100 pounds), as computed by the following formula: Adjusted Cord Breaking Strength in Newtons = 0.1382(m b p b R p (C) When the cord is attached to the ball by means of a knot, the end beneath the knot is chemically fused or otherwise treated to prevent the knot from slipping out or untying in use. (ii) The toy shall be tested at the time of production: (A) By using the sampling procedure described in the table in subdivision (vi) of this subparagraph to determine the number of units to be tested. (B) By subjecting each ball tested to 10 drops of a 2.25 kg (5-pound) steel impact rod or weight (57-mm (2 1/4 3/8 Adjusted drop height in mm = 179 × 10 −5 b p b R p Any ball showing any chipping, cracking, or shattering shall be counted as a failure within the meaning of the third column of the table in paragraph (a)(5)(vi) of this section. (C) By inspecting each ball tested for smoothness of finish on any surface of the ball which may come in contact with the cord during use. A cotton swab shall be rubbed vigorously over each such surface or area of the ball; if any cotton fibers are removed, the ball shall be counted as a failure within the meaning of the fourth column of the table in subdivision (vi) of this paragraph. The toy shall also be checked to ascertain that there is no visibly perceptible “wicking up” or “running up” of the casting resins on the outside of the cord in the vicinity where the ball is attached. (D) By fully assembling the toy and testing the cord in such a manner as to test both the strength of the cord and the adequacy with which the cord is attached to the ball and any holding device such as a tab or ring included in the assembly. The fully assembled article shall be vertically suspended by one ball and a 445-Newton (100-pound) test applied to the bottom ball. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may be tested with a force of under 445 Newtons (100 pounds). The test force for these clacker balls shall be the same as the cord breaking strength calculated in § 1500.86(a)(5)(i)(B). Any breaking, fraying, or unraveling of the cord or any sign of slipping, loosening, or unfastening shall be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section. (E) By additionally subjecting any ring or other holding device to a 222-Newton (50-pound) test load applied to both cords; the holding device is to be securely fixed horizontally in a suitable clamp in such a manner as to support 50 percent of the area of such holding device and the balls are suspended freely. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have their holding device tested with a force of less than 222 Newtons (50 pounds). The holding device test force for these clacker balls shall be half of the cord breaking strength calculated in § 1500.86(a)(5)(i)(B). Any breaking, cracking, or crazing of the ring or other holding device shall be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section. (F) By cutting each ball tested in half and then cutting each half perpendicularly to the first cut into three or more pieces of approximately equal thickness. Each portion is to be inspected before and after cutting, and any ball showing any flash, crack, crazing, or internal voids on such inspection is to be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section. Balls that are injection-molded and possess high-impact characteristics (such as injection-molded balls made of ABS, nylon, or high-impact polystyrene) though exempt from the requirements that there be no internal voids, must be tested to determine the presence of any flash, crack or grazing. A transparent ball shall be subjected to the same requirements except that it may be visually inspected without cutting. (iii) The toy shall be fully assembled for use at time of sale, including the proper attachments of balls, cords, knots, loops, or other holding devices. (iv) The toy shall be labeled: (A) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller. (B) To bear on the toy itself and/or the package containing the toy and/or the shipping container, in addition to the invoice(s) and shipping document(s), a code or mark in a form and manner that will permit future identification of any given batch, lot, or shipment by the manufacturer. (C) To bear a conspicuous warning statement on the main panel of the retail container and display carton and on any accompanying literature: That if cracks develop in a ball or if the cord becomes frayed or loose or unfastened, use of the toy should be discontinued; and if a ring or loop or other holding device is present, the statement “In use, the ring or loop must be placed around the middle finger and the two cords positioned over the forefinger and held securely between the thumb and forefinger,” or words to that effect which will provide adequate instructions and warnings to prevent the holding device from accidentally slipping out of the hand. Such statements shall be printed in sharply contrasting color within a borderline and in letters at least 6 mm ( 1/4 1/8 (v) The manufacturer of the toy shall make, keep, and maintain for 3 years records of sale, distribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available upon request at all reasonable hours by any officer or employee of the Consumer Product Safety Commission, and shall permit such officer or employee to inspect and copy such records and to make such inventories of stock as he deems necessary and otherwise to check the correctness of such records. (vi) The lot size, sample size, and failure rate for testing clacker balls are as follows: Number of units in batch, shipment, delivery, lot, or retail stock Number of units in random sample Failure rate constituting rejection when testing per § 1500.86(a)(5)(ii)(B) Failure rate constituting rejection when testing per § 1500.86(a)(5)(ii) (C), (D), (E), and (F) 50 or less 8 1 1 51 to 90 13 1 1 91 to 150 20 1 1 151 to 280 32 1 2 281 to 500 50 1 2 501 to 1,200 80 2 4 1,201 to 3,200 125 2 6 3,201 to 10,000 200 3 10 10,001 to 35,000 315 4 16 35,001 to 150,000 500 6 25 150,001 to 500,000 800 8 40 500,001 and over 1,250 11 62 (vii) Applicability of the exemption provided by this paragraph shall be determined through use of the table in paragraph (a)(5)(vi) of this section. A random sample of the number of articles as specified in the second column of the table shall be selected according to the number of articles in a particular batch, shipment, delivery, lot, or retail stock per the first column. A failure rate as shown in either the third or fourth column shall indicate that the entire batch, shipment, delivery, lot, or retail stock has failed and thus is not exempted under this paragraph from classification as a banned hazardous substance. (6) [Reserved] (7) Dive sticks and similar articles described in § 1500.18(a)(19) that come to rest at the bottom of a container of water in a position in which the long axis of the article is greater than 45 degrees from vertical when measured in accordance with the following test method: (i) Test equipment. (A) A container that is filled with tap water to a depth at least 3 inches [76 mm] greater than the longest dimension of the dive stick. The container shall: ( 1 ( 2 ( 3 (B) A protractor or other suitable angle measurement device that has an indicator for 45 degrees from vertical. (ii) Testing procedure (A) If the dive stick is sold such that the consumer is required to attach an additional component(s) to the dive stick, then the product shall be tested both with and without the attachment(s). (B) From just above the water surface, drop the dive stick into the container. (C) Let the dive stick sink and come to rest at the bottom of the container. If the dive stick is designed so that the weight can be adjusted by adding water or other substance, adjust the weight so that the dive stick sinks and comes to rest with its long axis positioned as close to vertical as possible. (D) Align the angle measurement device alongside the dive stick underwater and wait for the dive stick to come to rest if there is any water disturbance. Determine whether the long axis of the dive stick is greater than or less than 45 degrees from vertical. (8) Dive sticks and similar articles described in § 1500.18(a)(19) in which the maximum force measured in the following test method is less than 5-lbf [22N]. The test shall be conducted in the ambient environment of the laboratory and not under water. (i) Test equipment. (A) A compression rig that has a force gauge or equivalent device that is calibrated for force measurements within a minimum range of 0 to 5 lbf [0-22 N] and with an accuracy of ±0.1 lbf [±0.44 N] or better. The test rig shall have a system to guide this force application in the vertical direction and shall have a means to adjust the rate of load application. (B) Compression disk—the loading device that is attached to the force gauge shall be a rigid metal disk with a minimum diameter of 1.125 inches [29 mm]. (C) Vise or other clamping device. (ii) Testing procedure (A) Position the bottom of the dive stick in the clamping device so that the longest axis of the dive stick is vertical. The bottom end of the dive stick is the end that sinks to the bottom of a pool of water. Secure the bottom of the dive stick in the clamp such that the clamping mechanism covers no more than the bottom 1/2 (B) Apply a downward force at a rate of 0.05 in/sec (±0.01 in/sec) [1.3 mm.sec ±0.3 mm/sec] at the top of the dive stick with the compression disk positioned so that the plane of the disk contact surface is perpendicular to the long axis of the dive stick. (C) Apply the load for a period of 40 seconds or until the maximum recorded force exceeds 5-lbf [22 N]. (D) Record the maximum force that was measured during the test. (b) [Reserved] (9) Boston Billow Nursing Pillow and substantially similar nursing pillows that are designed to be used only as a nursing aide for breastfeeding mothers. For example, are tubular in form, C- or crescent-shaped to fit around a nursing mother's waist, round in circumference and filled with granular material. [38 FR 27012, Sept. 27, 1973, as amended at 53 FR 46839, Nov. 18, 1988; 59 FR 9076, 9077, Feb. 25, 1994; 66 FR 13651, Mar. 7, 2001; 68 FR 70140, Dec. 17, 2003; 73 FR 77495, Dec. 19, 2008; 75 FR 35282, June 21, 2010; 78 FR 66841, Nov. 7, 2013] § 1500.87 Children's products containing lead: inaccessible component parts. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm after three years, unless the Commission determines that it is not technologically feasible to have this lower limit. (b) Section 101 (b)(2) of the CPSIA provides that the lead limits do not apply to component parts of a product that are not accessible to a child. This section specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or electroplating may not be considered to be a barrier that would render lead in the substrate to be inaccessible to a child. (c) Section 101(b)(2)(B) of the CPSIA directs the Commission to promulgate by August 14, 2009, this interpretative rule to provide guidance with respect to what product components or classes of components will be considered to be inaccessible. (d) The accessibility probes specified for sharp points or edges under the Commissions' regulations at 16 CFR 1500.48-1500.49 will be used to assess the accessibility of lead-component parts of a children's product. A lead-containing component part would be considered accessible if it can be contacted by any portion of the specified segment of the accessibility probe. A lead-containing component part would be considered inaccessible if it cannot be contacted by any portion of the specified segment of the accessibility probe. (e) For products intended for children that are 18 months of age or less, the use and abuse tests set forth under the Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.51 (excluding the bite test of § 1500.51(c)), will be used to evaluate accessibility of lead-containing component parts of a children's product as a result of normal and reasonably foreseeable use and abuse of the product. (f) For products intended for children that are over 18 months but not over 36 months of age, the use and abuse tests set forth under the Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.52 (excluding the bite test of § 1500.52(c)), will be used to evaluate accessibility of lead-containing component parts of a children's product as a result of normal and reasonably foreseeable use and abuse of the product. (g) For products intended for children that are over 36 months but not over 96 months of age, the use and abuse tests set forth under the Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)), will be used to evaluate accessibility of lead-containing component parts of a children's product as a result of normal and reasonably foreseeable use and abuse of the product. (h) For products intended for children over 96 months through 12 years of age, the use and abuse tests set forth under the Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.53 (excluding the bite test of § 1500.53(c)) intended for children aged 37-96 months will be used to evaluate accessibility of lead-containing component parts of a children's product as a result of normal and reasonably foreseeable use and abuse of the product. (i) A children's product that is or contains a lead-containing part which is enclosed, encased, or covered by fabric and passes the appropriate use and abuse tests on such covers, is inaccessible to a child unless the product or part of the product in one dimension is smaller than 5 centimeters. (j) The intentional disassembly or destruction of products by children older than age 8 years by means or knowledge not generally available to younger children, including use of tools, will not be considered in evaluating products for accessibility of lead-containing components. [74 FR 39540, Aug. 7, 2009] § 1500.88 Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit will be further reduced to 100 ppm, unless the Commission determines that it is not technologically feasible to meet this lower limit. Section 101(b)(2) of the CPSIA further provides that the lead limits do not apply to component parts of a product that are not accessible to a child. This section specifies that a component part is not accessible if it is not physically exposed by reason of a sealed covering or casing and does not become physically exposed through reasonably foreseeable use and abuse of the product including swallowing, mouthing, breaking, or other children's activities, and the aging of the product, as determined by the Commission. Paint, coatings, or electroplating may not be considered to be a barrier that would render lead in the substrate to be inaccessible to a child. (b) Section 101(b)(4) of the CPSIA provides that if the Commission determines that it is not technologically feasible for certain electronic devices to comply with the lead limits, the Commission must issue requirements by regulation to eliminate or minimize the potential for exposure to and accessibility of lead in such electronic devices and establish a compliance schedule unless the Commission determines that full compliance is not technologically feasible within a schedule set by the Commission. (c) Certain accessible lead-containing component parts in children's electronic devices unable to meet the lead limits set forth in paragraph (a) of this section due to technological infeasibility are granted the exemptions that follow in paragraph (d) of this section below, provided that use of lead is necessary for the proper electronic functioning of the component part and it is not technologically feasible for the component part to meet the lead content limits set forth in paragraph (a) of this section. (d) Exemptions for lead as used in certain electronic components parts in children's electronic devices include: (1) Lead blended into the glass of cathode ray tubes, electronic components, and fluorescent tubes. (2) Lead used as an alloying element in steel. The maximum amount of lead shall be less than 0.35% by weight (3,500 ppm). (3) Lead used in the manufacture of aluminum. The maximum amount of lead shall be less than 0.4% by weight (4,000 ppm). (4) Lead used in copper-based alloys. The maximum amount of lead shall be less than 4% by weight (40,000 ppm). (5) Lead used in lead-bronze bearing shells and bushings. (6) Lead used in compliant pin connector systems. (7) Lead used in optical and filter glass. (8) Lead oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used in structural elements; notably in the front and rear glass dielectric layer, the bus electrode, the black stripe, the address electrode, the barrier ribs, the seal frit and frit ring, as well as in print pastes. (9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps. (e) Components of electronic devices that are removable or replaceable, such as battery packs and light bulbs that are inaccessible when the product is assembled in functional form or are otherwise granted an exemption, are not subject to the lead limits in paragraph (a) of this section. (f) Commission staff is directed to reevaluate and report to the Commission on the technological feasibility of compliance with the lead limits in paragraph (a) of this section for children's electronic devices, including the technological feasibility of making accessible component parts inaccessible, and the status of the exemptions, no less than every five years after publication of a final rule in the Federal Register [75 FR 3158, Jan. 20, 2010] § 1500.89 Procedures and requirements for determinations regarding lead content of materials or products under section 101(a) of the Consumer Product Safety Improvement Act. (a) The Consumer Product Safety Improvement Act provides for specific lead limits in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 years of age or younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 years of age or younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit will be further reduced to 100 ppm, unless the Commission determines that this lower limit is not technologically feasible. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inaccessible to a child or prevent the absorption of any lead in the human body through normal and reasonably foreseeable use and abuse of the product. (b) The Commission may, either on its own initiative or upon the request of any interested person, make a determination that a material or product does not contain leads levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable. (c) A determination by the Commission under paragraph (b) of this section that a material or product does not contain lead levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable does not relieve the material or product from complying with the applicable lead limit as provided under paragraph (a) of this section. (d) To request a determination under paragraph (b) of this section, the request must: (1) Be e-mailed to [email protected]. (2) Be written in the English language. (3) Contain the name and address, and e-mail address or telephone number, of the requestor. (4) Provide documentation including: (i) A detailed description of the product or material and how it is used by a child; (ii) Representative data on the lead content of parts of the product or materials used in the production of a product; (iii) All relevant data or information on manufacturing processes through which lead may be introduced into the material or product; (iv) An assessment of the likelihood or lack thereof that the manufacturing processes will result in lead contamination of a material or product that ordinarily does not contain lead; (v) All relevant data or information on the facilities used to manufacture the material or product, and any other materials used in the product; (vi) An assessment of the likelihood or lack thereof that the use of leaded materials in a facility will result in lead contamination of a material or product that ordinarily does not contain lead; (vii) Any other information relevant to the potential for lead content of the product or material to exceed the statutory lead limit specified in the request, that is 600 ppm, 300 ppm, or 100 ppm, as applicable; (viii) Detailed information on the relied upon test methods for measuring lead content of products or materials including the type of equipment used or any other techniques employed and a statement as to why the data is representative of the lead content of such products or materials generally; and (ix) Any data or information that is unfavorable to the request that is reasonably available to the requestor. (e) Where a submission fails to meet all of the requirements of paragraph (d) of this section, the Office of the Secretary shall notify the person submitting it, describe the deficiency, and explain that the request may be resubmitted when the deficiency is corrected. (f) Upon receipt of a complete request for a determination, the Office of Hazard Identification and Reduction (EXHR) will assess the request to determine whether the product or material is one that does not contain lead in excess of the limits as provided under paragraph (a) of this section. EXHR will make an initial recommendation within thirty (30) calendar days, to the extent practicable. EXHR may request an extension from the Executive Director of the CPSC, if necessary, to make its initial determination. A complete request is one that does not require additional information from the requestor for EXHR to make an initial recommendation to the Commission. (g) Where the Office of Hazard Identification and Reduction's (EXHR) initial recommendation is to deny the request for a lead content determination, it will provide, in a staff memorandum to the Commission, submitted to the Commission for ballot vote, the basis for the denial with sufficient detail for the Commission to make an informed decision that reasonable grounds for a determination are not presented. The Commission, by ballot vote, will render a decision on the staff's recommendation. The ballot vote and the staff memorandum will be posted on the CPSC Web site. Any determination by the Commission to grant a request will be published in the Federal Register (h) Where the Office of Hazard Identification and Reduction's (EXHR) initial recommendation is to grant the request for a lead content determination, it will submit the basis for that recommendation to the Commission in a memorandum to be voted on by ballot, with sufficient detail for the Commission to make an informed decision that reasonable grounds for a determination are presented. If the notice of proposed rulemaking (NPR) is published, it will invite public comment in the Federal Register. Federal Register. (i) The filing of a request for a determination does not have the effect of staying the effect of any provision or limit under the statutes and regulations enforced by the Commission. Even though a request for a determination has been filed, unless a Commission determination is issued in final form after notice and comment, materials or products subject to the lead limits under section 101 of the CPSIA must be tested in accordance with section 102 of the CPSIA, unless the testing requirement is otherwise stayed by the Commission. [74 FR 10480, Mar. 11, 2009] § 1500.90 Procedures and requirements for exclusions from lead limits under section 101(b) of the Consumer Product Safety Improvement Act. (a) The Consumer Product Safety Improvement Act provides for specific lead limits in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 years of age or younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 years of age or younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit will be further reduced to 100 ppm, unless the Commission determines that this lower limit is not technologically feasible. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inaccessible to a child or prevent the absorption of any lead in the human body through normal and reasonably foreseeable use and abuse of the product. (b) Exclusion of certain materials or products and inaccessible component parts. (1) Functional purpose exception In general. (A) The product, class of product, material, or component part requires the inclusion of lead because it is not practicable or not technologically feasible to manufacture such product, class of product, material, or component part, as the case may be, in accordance with paragraph (a) of this section by removing the excessive lead or by making the lead inaccessible; (B) The product, class of product, material, or component part is not likely to be placed in the mouth or ingested, taking into account normal and reasonably foreseeable use and abuse of such product, class of product, material, or component part by a child; and (C) An exception for the product, class of product, material, or component part will have no measurable adverse effect on public health or safety, taking into account normal and reasonably foreseeable use and abuse. (ii) Measurement. (iii) Procedures for granting exception Burden of proof. (B) Grounds for decision. (C) Admissible evidence. (D) Scope of exception. (iv) Limitation on exception. (A) Establish a lead limit that such product, class of product, material, or component part may not exceed; or (B) Place a manufacturing expiration date on such exception or establish a schedule after which the manufacturer of such product, class of product, material, or component part shall be in full compliance with the limit established under paragraph (b)(1)(iv)(A) of this section or the limit set forth under paragraph (a) of this section. (v) Application of exception. (vi) Previously submitted petitions. (2) [Reserved] [74 FR 10480, Mar. 11, 2009, as amended at 78 FR 41298, July 10, 2013] § 1500.91 Determinations regarding lead content for certain materials or products under section 101 of the Consumer Product Safety Improvement Act. (a) The Consumer Product Safety Improvement Act provides for specific lead limits in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more than 300 ppm of lead. On August 14, 2011, the limit may be further reduced to 100 ppm, unless the Commission determines that it is not technologically feasible to have this lower limit. Paint, coatings or electroplating may not be considered a barrier that would make the lead content of a product inaccessible to a child. Materials used in products intended primarily for children 12 and younger that are treated or coated with paint or similar surface-coating materials that are subject to 16 CFR part 1303, must comply with the requirements for lead paint under section 14(a) of the Consumer Product Safety Act (CPSA), as amended by section 102(a) of the CPSIA. (b) Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, either on its own initiative or upon the request of any interested person, to make a determination that a material or product does not exceed the lead limits as provided under paragraph (a) of this section. (c) A determination by the Commission under paragraph (b) of this section that a material or product does not contain lead levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable, does not relieve the material or product from complying with the applicable lead limit as provided under paragraph (a) of this section if the product or material is changed or altered so that it exceeds the lead content limits. (d) The following materials do not exceed the lead content limits under section 101(a) of the CPSIA provided that these materials have neither been treated or adulterated with the addition of materials that could result in the addition of lead into the product or material: (1) Precious gemstones: diamond, ruby, sapphire, emerald. (2) Semiprecious gemstones and other minerals, provided that the mineral or material is not based on lead or lead compounds and is not associated in nature with any mineral based on lead or lead compounds (excluding any mineral that is based on lead or lead compounds including, but not limited to, the following: aragonite, bayldonite, boleite, cerussite, crocoite, galena, linarite, mimetite, phosgenite, vanadinite, and wulfenite). (3) Natural or cultured pearls. (4) Wood. (5) Paper and similar materials made from wood or other cellulosic fiber, including, but not limited to, paperboard, linerboard and medium, and coatings on such paper which become part of the substrate. (6) CMYK process printing inks (excluding spot colors, other inks that are not used in CMYK process, inks that do not become part of the substrate under 16 CFR part 1303, and inks used in after-treatment applications, including screen prints, transfers, decals, or other prints). (7) Textiles (excluding any textiles that contain treatments or applications that do not consist entirely of dyes) consisting of: (i) Natural fibers (dyed or undyed) including, but not limited to, cotton, kapok, flax, linen, jute, ramie, hemp, kenaf, bamboo, coir, sisal, silk, wool (sheep), alpaca, llama, goat (mohair, cashmere), rabbit (angora), camel, horse, yak, vicuna, qiviut, guanaco; (ii) Manufactured fibers (dyed or undyed) including, but not limited to, rayon, azlon, lyocell, acetate, triacetate, rubber, polyester, olefin, nylon, acrylic, modacrylic, aramid, spandex. (8) Other plant-derived and animal-derived materials including, but not limited to, animal glue, bee's wax, seeds, nut shells, flowers, bone, sea shell, coral, amber, feathers, fur, leather. (e) The following metals and alloys do not exceed the lead content limits under section 101(a) of the CPSIA, provided that no lead or lead-containing metal is intentionally added but does not include the non-steel or non-precious metal components of a product, such as solder or base metals in electroplate, clad, or fill applications: (1) Surgical steel and other stainless steel within the designations of Unified Numbering System, UNS S13800-S66286, not including the stainless steel designated as 303Pb (UNS S30360). (2) Precious metals: Gold (at least 10 karat); sterling silver (at least 925/1000); platinum; palladium; rhodium; osmium; iridium; ruthenium, titanium. [74 FR 43041, Aug. 26, 2009, as amended at 80 FR 61732, Oct. 14, 2015] § 1500.121 Labeling requirements; prominence, placement, and conspicuousness. (a)(1) Background and scope. (2) Definitions. (i) Container (ii) Cautionary material, cautionary labeling, cautionary labeling required by the Act (iii) Display panel (iv) Principal display panel (v) Type size (vi) Signal word (vii) Statement of principal hazard(s) (viii) Other cautionary material (b) Prominent label placement. (1) Horizontal placement of labeling statements. (2) Principal display panel labeling. (ii) The signal word, the statement of principal hazard(s), and, if appropriate, instructions to read carefully any cautionary material that may be placed elsewhere on the label shall be blocked together within a square or rectangular area, with or without a border, on the principal display panel on the immediate container and, where required by paragraph (b)(4) of this section, on any outer container or wrapping. All cautionary statements placed on the principal display panel shall be separated on all sides from other printed or graphic matter, with the exception of the declaration of net contents required under the Fair Packaging and Labeling Act, 15 U.S.C. 1453(a) (2) and (3), by a border line or by a space no smaller than the minimum allowable height of the type size for cautionary material required by the Act (exclusive of signal words and statements of hazard) on the principal display panel. (iii) Depending on the design of the package or the configuration of the label, or both, a package may have more than one principal display panel. If so, each principal display panel must bear, at a minimum, the signal word, statement of principal hazard or hazards, and, if appropriate, instructions to read carefully any cautionary material that may be placed elsewhere on the label. (A) Where the principal display panel of the immediate container consists of a lid, cap, or other item which may be separated from the immediate container and discarded, the container shall be deemed to have a second principal display panel elsewhere on the immediate container which must bear, at a minimum, the signal word, statement of principal hazard(s), and instructions, if appropriate, to read any cautionary material which may be placed elsewhere on the label. (3) Prominent label placement—other display panel labeling. (4) Outer container or wrappings. (5) Placement of the word “Poison” and the skull and crossbones symbol. (i) If a hazardous substance is “highly toxic,” as defined in § 1500.3(c)(i) and section 2(h)(1) of the FHSA, the label must bear the word “poison” in accordance with section 2(p)(1)(H) of the Act, in addition to the signal word “DANGER,” and must also bear the skull and crossbones symbol. Some products, under § 1500.14(b) of the regulations, may, in addition to any required signal word, be required to bear the word “poison” and the skull and crossbones symbol because of the special hazard associated with their ingredients. In both instances, the word “poison” and the skull and crossbones symbol need not appear on the principal display panel on the container, unless all other cautionary labeling required by the Act appears on the principal display panel. The word “poison” and the skull and crossbones symbol, when required, must appear either together with other cautionary labeling on a display panel other than the principal display panel or together with the signal word and statement(s) of principal hazard on the principal display panel. (ii) Where, pursuant to a regulation issued under section 3(b) of the Act, the label of a hazardous substance requires the word “poison” instead of a signal word, the word, “POISON” shall appear in capital letters on the principal display panel, together with the statement(s) of the principal hazard. Certain substances for which the word “poison” is required instead of any signal word are listed in § 1500.129. (c) Conspicuousness—type size and style. (1) Area of principal display panel. (i) In the case of a rectangular package, where one entire side is the principal display panel, the product of the height times the width of that side shall be the area of the principal display panel. (ii) In the case of a cylindrical or nearly cylindrical container or tube on which the principal display panel appears on the side, the area of the principal display panel shall be 40 percent of the product of the height of the container times its circumference. (iii) In the case of any other shape of container, the area of the principal display panel shall be 40 percent of the total surface of the container, excluding those areas, such as flanges at tops and bottoms, specified in paragraph (c)(1) above. However, if such a container presents an obvious principal display panel (such as an oval or hour-glass shaped area on the side of a container for dishwashing detergent), the area to be measured shall be the entire area of the obvious principal display panel. (2) Type-size requirements. type size (ii) When an item of labeling is required to be in a specified type size, all upper case, or capital, letters must be at least equal in height to the required type size, and all other letters must be the same style as the upper case or capital letters. Unless otherwise specified in the regulations (examples appear at §§ 1500.14(b)(6), 1512.19, 1508.9, and part 1505), the type size of all cautionary statements appearing on any display panel shall comply with the specifications in table 1 when the area of the display panel is measured by the method in paragraph (c)(1) above: Table I Area of principal display panel in square inches 0-2 >2-5 >5-10 >10-15 >15-30 >30 Type size in inches * Signal word ** 3 64 1 16 3 32 7 64 1 8 5 32 Statement of hazard 3 64 3 64 1 16 3 32 3 32 7 64 Other cautionary material *** 1 32 3 64 1 16 1 16 5 64 3 32 > means “greater than.” * minimum height of printed image of capital or upper case letters. ** including the word “poison” when required instead of a signal word by Section 3(b) of the Act (§ 1500.129). *** size of lettering for other cautionary material is based on the area of the display panel on which such cautionary material appears. (iii) If all of the required cautionary labeling does not appear on the principal display panel, the statement to “Read carefully other cautions on the ___ panel,” or its practical equivalent, must appear in, as a minimum, the same type size as that required in table 1 for the other cautionary material which appears elsewhere on the label of a hazardous substance. The size of the cautionary labeling that does not appear on the principal display panel is determined by the area of the panel on which it does appear. (3) Type style—proportion. (4) Signal word and statements of hazard—capital letters. (5) Multiple statement of hazard—type size and style. (6) Accompanying literature containing directions for use. (i) All such cautionary labeling shall be in reasonable proximity to any direction for use and shall be placed together within the same general area. (ii) The type size of such cautionary labeling shall be reasonably related to the type size of any other printed matter in the accompanying literature and must be in conspicuous and legible type by typography, layout, or color with other printed matter on the label. The signal word and statement of principal hazard or hazards shall appear in capital letters. (d) Conspicuousness—contrast. (1) Color. (2) Interference with conspicuousness—labeling design, vignettes, or other printed material. (e) Collapsible metal tubes. (f) Unpackaged hazardous substances. (g) Exemptions. (h) Effective date. [49 FR 50383, Dec. 28, 1984] § 1500.122 Deceptive use of disclaimers. A hazardous substance shall not be deemed to have met the requirements of section 2(p) (1) and (2) of the act (repeated in § 1500.3(b)(14) (i) and (ii)) if there appears in or on the label (or in any accompanying literature; words, statements, designs, or other graphic material that in any manner negates or disclaims any of the label statements required by the act; for example, the statement “Harmless” or “Safe around pets” on a toxic or irritant substance. § 1500.123 Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides the precautionary measures to be followed or avoided, a clear statement of the principal hazard will satisfy the requirements of section 2(p)(1) (E) and (F) of the act (repeated in § 1500.3(b)(14)(i) (E) and (F)). When the statement of precautionary measures in effect provides instruction for first-aid treatment, the statement of the precautionary measures will satisfy the requirements of section 2(p)(1) (F) and (G) of the act (repeated in § 1500.3(b)(14)(i) (F) and (G)). § 1500.125 Labeling requirements for accompanying literature. When any accompanying literature includes or bears any directions for use (by printed word, picture, design, or combination thereof), such placard, pamphlet, booklet, book, sign, or other graphic or visual device shall bear all the information required by section 2(p) of the act (repeated in § 1500.3(b)(14)). § 1500.126 Substances determined to be “special hazards.” Whenever the Commission determines that for a particular hazardous substance intended or packaged in a form suitable for use in the household or by children, the requirements of section 2(p) of the act (repeated in § 1500.3(b)(14)) are not adequate for the protection of the public health and safety because of some special hazard, the Commission, by an appropriate order in the Federal Register, § 1500.127 Substances with multiple hazards. (a) Any article that presents more than one type of hazard (for example, if the article is both toxic and flammable) must be labeled with: An affirmative statement of each such hazard; the precautionary measures describing the action to be followed or avoided for each such hazard; instructions, when necessary or appropriate, for first-aid treatment of persons suffering from the ill effects that may result from each such hazard; instructions for handling and storage of articles that require special care in handling and storage because of more than one type of hazard presented by the article; and the common or usual name (or the chemical name if there is no common or usual name) for each hazardous component present in the article. (b) Label information referring to the possibility of one hazard may be combined with parallel information concerning any additional hazards presented by the article if the resulting condensed statement contains all of the information needed for dealing with each type of hazard presented by the article. [38 FR 27012, Sept. 27, 1973; 38 FR 30105, Nov. 1, 1973] § 1500.128 Label comment. The Commission will offer informal comment on any proposed label and accompanying literature involving a hazardous substance if furnished with: (a) Complete labeling or proposed labeling, which may be in draft form. (b) Complete quantitative formula. (c) Adequate clinical pharmacological, toxicological, physical, and chemical data applicable to the possible hazard of the substance. (d) Any other information available that would facilitate preparation of a suitable label, such as complaints of injuries resulting from the product's use or other evidence that would furnish human-experience data. § 1500.129 Substances named in the Federal Caustic Poison Act. The Commission finds that for those substances covered by the Federal Caustic Poison Act (44 Stat. 1406), the requirements of section 2(p)(1) of the Federal Hazardous Substances Act (repeated in § 1500.3(b)(14)(i)) are not adequate for the protection of the public health. Labeling for those substances, in the concentrations listed in the Federal Caustic Poison Act, were required to bear the signal word “poison.” The Commission concludes that the lack of the designation “poison” would indicate to the consumer a lesser hazard and that such would not be in the interest of the public health. Under the authority granted in section 3(b) of the act, the Commission therefore finds that for the following substances, and at the following concentrations, the word “poison” is necessary instead of any signal word: (a) Hydrochloric acid and any preparation containing free or chemically unneutralized hydrochloric acid (HCl) in a concentration of 10 percent or more. (b) Sulfuric acid and any preparation containing free or chemically unneutralized sulfuric acid (H 2 4 (c) Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO 3 (d) Carbolic acid (C 6 5 (e) Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (H 2 2 4 (f) Any salt of oxalic acid and any preparation containing any such salt in a concentration of 10 percent or more. (g) Acetic acid or any preparation containing free or chemically unneutralized acetic acid (HC 2 2 2 (h) Hypochlorous acid, either free or combined, and any preparation containing the same in a concentration that will yield 10 percent or more by weight of available chlorine. (i) Potassium hydroxide and any preparation containing free or chemically unneutralized potassium hydroxide (KOH), including caustic potash and vienna paste (vienna caustic), in a concentration of 10 percent or more. (j) Sodium hydroxide and any preparation containing free or chemically unneutralized sodium hydroxide (NaOH), including caustic soda and lye in a concentration of 10 percent or more. (k) Silver nitrate, sometimes known as lunar caustic, and any preparation containing silver nitrate (AgNO 3 (l) Ammonia water and any preparation containing free or chemically uncombined ammonia (NH 3 § 1500.130 Self-pressurized containers: labeling. (a) Self-pressurized containers that fail to bear a warning statement adequate for the protection of the public health and safety may be misbranded under the act, except as otherwise provided pursuant to section 3 of the act. (b) The following warning statement will be considered as meeting the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) if the only hazard associated with an article is that the contents are under pressure: warning—contents under pressure Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120 °F. Keep out of the reach of children. The word “CAUTION” may be substituted for the word “WARNING”. A practical equivalent may be substituted for the statement “Keep out of the reach of children.” (c) That portion of the warning statement set forth in paragraph (b) of this section in capital letters should be printed on the main (front) panel of the container in capital letters of the type size specified in § 1500.121(c). The balance of the cautionary statements may appear together on another panel if the front panel also bears a statement such as “Read carefully other cautions on _____ panel.” (d) If an article has additional hazards, such as skin or eye irritancy, toxicity, or flammability, appropriate additional front and rear panel precautionary labeling is required. § 1500.133 Extremely flammable contact adhesives; labeling. (a) Extremely flammable contact adhesives, also known as contact bonding cements, when distributed in containers intended or suitable for household use may be misbranded under the act if the containers fail to bear a warning statement adequate for the protection of the public health and safety. (b) The following warning statement is considered as the minimum cautionary labeling adequate to meet the requirements of section 2(p)(1) of the act (repeated in § 1500.3(b)(14)(i)) with respect to containers of more than one-half pint of contact adhesive and similar liquid or semiliquid articles having a flashpoint at or below 20 °F. as determined by the method in § 1500.43, when the only hazard foreseeable is that caused by the extreme flammability of the mixture: Danger Extremely Flammable Vapors May Cause Flash Fire Vapors may ignite explosively. Prevent buildup of vapors—open all windows and doors—use only with cross-ventilation. Keep away from heat, sparks, and open flame. Do not smoke, extinguish all flames and pilot lights, and turn off stoves, heaters, electric motors, and other sources of ignition during use and until all vapors are gone. Close container after use. Keep out of the reach of children. (c) The words that are in capital letters in the warning statement set forth in paragraph (b) of this section should be printed on the main (front) panel or panels of the container in capital letters of the type size specified in § 1500.121(c). The balance of the cautionary information may appear together on another panel provided the front panel bears a statement such as “Read carefully other cautions on ___ panel,” the blank being filled in with the identification of the specific label panel bearing the balance of the cautionary labeling. It is recommended that a borderline be used in conjunction with the cautionary labeling. (d) If an article has additional hazards, or contains ingredients listed in § 1500.14 as requiring special labeling, appropriate additional front and rear panel precautionary labeling is required. (e) Since the Commission has issued a regulation banning under the Consumer Product Safety Act extremely flammable contact adhesives covered by this labeling regulation (sec. 16 CFR part 1302), paragraphs (a), (b), (c) and (d) of this section are revoked as to the subject products after June 13, 1978. [38 FR 27012, Sept. 27, 1973, as amended at 42 FR 63742, Dec. 19, 1977] § 1500.134 Policy on first aid labeling for saline emesis. (a) This section states the Consumer Product Safety Commission's policy concerning first aid instructions for the use of a salt solution to induce vomiting (saline emesis) in the event of ingestion of hazardous substances. (b) In many cases where hazardous substances are ingested, the recommended first aid instructions for inducing vomiting have contained a statement that this should be accomplished by drinking a solution of salt (sodium chloride) in warm water. At one time, this direction was considered medically acceptable. However, the Commission has obtained information showing that the instruction to perform saline emesis is no longer appropriate. This is because the use of salt to induce vomiting can cause severe hypernatremia (salt poisoning) with potentially toxic effects, particularly in children 5 years old or younger, the age group most often involved in accidental poisonings. In view of the availability of safer and more effective emetics such as ipecac syrup, the Commission no longer recommends a direction to perform saline emesis as a first aid direction for inducing vomiting. (c) The Commission believes that, for products for which directions for saline emesis have been given in the past, ipecac syrup, U.S.P., is the most appropriate emetic, unless a particular contraindication exists in connection with any particular hazardous substance. (d) The Commission wishes to emphasize that this policy does not require that any specific first aid instruction or wording be used. Where appropriate, the label may include directions (1) that the victim immediately contact a doctor or poison control center and/or (2) that vomiting be induced using methods other than salt. It is, of course, the manufacturer's responsibility to insure that the label provides enough information in addition to first aid instructions to fulfill all other labeling required by statute or regulation. (Sec. 30(a), 86 Stat. 1231 (15 U.S.C. 2079(a))) [43 FR 33704, Aug. 1, 1978] § 1500.135 Summary of guidelines for determining chronic toxicity. A substance may be toxic due to a risk of a chronic hazard. (A regulatory definition of “toxic” that pertains to chronic toxicity may be found at 16 CFR 1500.3(c)(2).) The following discussions are intended to help clarify the complex issues involved in assessing risk from substances that may potentially cause chronic hazards and, where possible, to describe conditions under which substances should be considered toxic due to a risk of the specified chronic hazards. The guidelines are not intended to be a static classification system, but should be considered along with available data and with expert judgment. They are not mandatory. Rather, the guidelines are intended as an aid to manufacturers in determining whether a product subject to the FHSA presents a chronic hazard. All default assumptions contained in the guidelines on hazard and risk determination are subject to replacement when alternatives which are supported by appropriate data become available. The following are brief summaries of more extensive discussions contained in the guidelines. Thus, the guidelines should be consulted in conjunction with these summaries. Copies of the guidelines may be obtained from the Office of Compliance and Enforcement, Consumer Product Safety Commission, Washington, DC 20207. (In addition to the chronic hazards discussed below, issues relating to the chronic hazard of sensitization are discussed in 16 CFR 1500.3(c)(5).) (a) Carcinogenicity. (1) Known Human carcinogenic Substances (“sufficient evidence” in humans). (i) No identified bias that can account for the observed association has been found on evaluation of the evidence. (ii) All possible confounding factors which could account for the observed association can be ruled out with reasonable confidence. (iii) Based on statistical analysis, the association has been shown unlikely to be due to chance. (2) Probable Human Carcinogenic Substances. (i) “Limited evidence” of carcinogenicity in humans. (ii) “Sufficient evidence” of carcinogenicity in animals. (A) In one or both sexes of multiple species, strains, or sites of independent origin; or experiments using different routes of administration or dose levels; or (B) To an unusual degree in a single experiment (one species/strain/sex) with regard to unusual tumor type, unusual tumor site, or early age at onset of the tumor. The presence of positive effects in short-term tests, dose-response effects data, or structure-activity relationship are considered additional evidence. (3) Possible Human Carcinogenic Substance (“limited evidence” animal carcinogen). (b) Neurotoxicity. (1) Known Neurotoxic Substances (“sufficient evidence in humans”). (i) A consistent pattern of neurological dysfunction is observed. (ii) The adverse effects/lesions account for the neurobehavioral dysfunction with reasonable certainty. (iii) All identifiable bias and confounding factors are reasonably discounted after consideration. (iv) The association has been shown unlikely to be due to chance, based on statistical analysis. (2) Probable Neurotoxic Substances. (i) “Limited evidence” of neurotoxicity in humans. (ii) “Sufficient evidence” of neurotoxicity in animals. (A) The substance has been tested in well-designed and -conducted studies (e.g., NTP's neurobehavioral battery, or conforming to EPA's neurotoxicity test guidelines); and (B) The substance has been found to elicit a statistically significant (p <0.05) increase in any neurotoxic effect in one or both sexes of multiple species, strains, or experiments using different routes of administration and dose-levels. (3) Possible Neurotoxic Substances. (c) Developmental and Reproductive Toxicity Definitions of “Sufficient” and “Limited” Evidence. (i) “Sufficient evidence” from human studies for a causal association between human exposure and the subsequent occurrence of developmental or reproductive toxicity is considered to exist if the studies meet the following criteria: (A) No identified bias that can account for the observed association has been found on evaluation of the evidence. (B) All possible confounding factors which could account for the observed association can be ruled out with reasonable confidence. (C) Based on statistical analysis, the association has been shown unlikely to be due to chance. (ii) “Limited evidence” from human studies exists when the human epidemiology meets all but one of the criteria for “sufficient evidence”; i.e., the statistical evidence is borderline as opposed to clear-cut, there is a source of bias, or there are confounding factors that have not been and cannot be accounted for. (iii) “Sufficient evidence” from animal studies exists when (A) Obtained from a good quality animal study; and (B) The substance has been found to elicit a statistically significant (p<0.05) treatment-related increase in multiple endpoints in a single species/strain, or in the incidence of a single endpoint at multiple dose levels or with multiple routes of administration in a single species/strain, or increase in the incidence of a single endpoint in multiple species/strains/ experiments. (iv) “Limited evidence” from animal studies exists when: (A) Obtained from a good quality study and there is a statistically significant (p<0.05) treatment-related increase in the incidence of a single endpoint in a single species/strain/experiment at a single dose level administered through only one route and such evidence otherwise does not meet the criteria for “sufficient evidence”; or (B) The evidence is derived from studies which can be interpreted to show positive effects but have some qualitative or quantitative limitations with respect to experimental procedures (e.g., doses, exposure, follow-up, number of animals/group, reporting of the data, etc.) which would prevent classification of the evidence in the group of “sufficient evidence.” (2) Developmental Toxicants. (i) Known Human Developmental Toxicant (“sufficient evidence in humans”). (ii) Probable Human Developmental Toxicant. (iii) Possible Human Developmental Toxicant. (3) Male Reproductive Toxicants. (i) Known Human Male Reproductive Toxicant. (ii) Probable Human Male Reproductive Toxicant. (iii) Possible Human Male Reproductive Toxicant. (4) Female Reproductive Toxicants. (i) Known Human Female Reproductive Toxicant. (ii) Probable Human Female Reproductive Toxicant. (iii) Possible Human Female Reproductive Toxicant. (d) Other Subjects Related to the Determination that a Substance is Toxic. (1) Assessment of Exposure. (i) Inhalation. (A) Direct Monitoring. (B) Modeling. (C) Surrogate Data. (ii) Oral Ingestion. (A) A simulant or range of simulants should be carefully selected to mimic the possible range of conditions which occur in humans, such as full and empty stomachs, or various saliva compositions at different times of the day. (B) The mechanical action to which a product is submitted must be chosen to represent some range of realistic conditions to which a human may subject the product. (iii) Dermal Exposure. (B) Parameters to be considered include: Surface area of the skin contacted, duration of contact, frequency of contact, and thickness of a liquid interfacial layer. (2) Assessment of Bioavailability. (ii) In determining the need to assess bioavailability, the factors to be examined include: (A) The physical or chemical form of the substance, (B) The route of exposure (inhalation, ingestion, or through the skin), (C) The presence of other constituents in the product which interfere with or alter absorption of the toxic substance, and (D) Dose. (3) Assessment of Risk. (i) Generally, the study leading to the highest risk should be used in the risk assessment; however, other factors may influence the choice of study. (ii) Risk should be based on the maximum likelihood estimate from a multistage model (such as Global83 or later version) unless the maximum likelihood estimate is not linear at low dose, in which case the 95% upper confidence limit on risk should be used. (iii) For systemic carcinogens, if estimates of human risk are made based on animal data, a factor derived from dividing the assumed human weight (70 kg) by the average animal weight during the study and taking that to the 1/3 1/4 1/3 (iv) When dose is expressed as parts per million, and the carcinogen acts at the site of contact, humans and animals exposed to the same amount for the same proportion of lifetime should be assumed to be equally sensitive. (v) If no experimental study having the same route of exposure as that anticipated for human use of a substance is available, a study by another route of exposure may be used. Pharmacokinetic methods may be used if sufficient data are available. (vi) When exposure scenarios are different from those used in the underlying study upon which estimates of risk are based, proportionality should be applied. If pharmacokinetic methods are used to adjust for risks at high versus low exposure levels, level-time measures should not be combined without taking the non-linearity into account. (4) Acceptable Risks ADI for Carcinogens. (ii) ADI for Neurotoxicological and Developmental/Reproductive Agents. (A) Human Data. (B) Animal Data. [57 FR 46665, Oct. 9, 1992] § 1500.210 Responsibility. The provisions of these regulations (16 CFR subchapter C of chapter II) with respect to the doing of any act shall be applicable also to the causing of such act to be done. § 1500.211 Guaranty. In the case of the giving of a guaranty or undertaking referred to in section 5(b)(2) of the act, each person signing such guaranty or undertaking, or causing it to be signed, shall be considered to have given it. Each person causing a guaranty or undertaking to be false is chargeable with violations of section 4(d) of the act. § 1500.212 Definition of guaranty; suggested forms. (a) A guaranty or undertaking referred to in section 5(b)(2) of the act may be: (1) Limited to a specific shipment or other delivery of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment of delivery; or (2) General and continuing, in which case, in its application to any shipment or other delivery of an article, it shall be considered to have been given at the date such article was shipped or delivered, or caused to be shipped or delivered, by the person who gives the guaranty of undertaking. (b) The following are suggested forms of guaranty or undertaking referred to in section 5(b)(2) of the act. (1) Limited form for use on invoice or bill of sale. (Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is misbranded within the meaning of the Federal Hazardous Substances Act. (Signature and post-office address of person giving the guaranty or undertaking) (2) General and continuing forms. The article comprising each shipment or other delivery hereafter made by _____ (Name of person giving the guaranty or undertaking) to, or on the order of __________ (Name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not misbranded within the meaning of the Federal Hazardous Substances Act. (Signature and post-office address of person giving the guaranty or undertaking) (c) The application of a guaranty or undertaking referred to in section 5(b)(2) of the act to any shipment or other delivery of an article shall expire when such article, after shipment or delivery by the person who gave such guaranty or undertaking, becomes misbranded within the meaning of the act. § 1500.213 Presentation of views under section 7 of the act. (a) Presentation of views under section 7 of the act shall be private and informal. The views presented shall be confined to matters relevant to the contemplated proceeding. Such views may be presented by letter or in person by the person to whom the notice was given, or by his representative. In case such person holds a guaranty or undertaking referred to in section 5(b)(2) of the act applicable to the article on which such notice was based, such guaranty or undertaking, or a verified copy thereof, shall be made a part of such presentation of views. (b) Upon request, reasonably made, by the person to whom a notice appointing a time and place for the presentation of views under section 7 of the act has been given, or by his representative, such time or place, or both such time and place, may be changed if the request states reasonable grounds therefor. Such request shall be addressed to the office of the Consumer Product Safety Commission that issued the notice. § 1500.214 Examinations and investigations; samples. When any officer or employee of the Commission collects a sample of a hazardous substance for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Commission indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory not organized with a legislative body. Only samples so designated by an officer or employee of the Commission shall be considered to be official samples: (a) For the purpose of determining whether or not a sample is collected for analysis, the term “analysis” includes examinations and tests. (b) The owner of a hazardous substance of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected. § 1500.230 Guidance for lead (Pb) in consumer products. (a) Summary. 1 1 (2) To reduce the risk of hazardous exposure to lead, the Commission requests manufacturers to eliminate the use of lead that may be accessible to children from products used in or around households, schools, or in recreation. The Commission also recommends that, before purchasing products for resale, importers, distributors, and retailers obtain assurances from manufacturers that those products do not contain lead that may be accessible to children. (b) Hazard. (c) Guidance. (2) Paint and similar surface coatings containing lead have historically been the most commonly-recognized sources of lead poisoning among the products within the Commission's jurisdiction. The Commission has, by regulation, banned paint and other similar surface coatings that contain more than 0.06% lead (“lead-containing paint”), toys and other articles intended for use by children that bear lead-containing paint, and furniture articles for consumer use that bear lead-containing paint. 16 CFR Part 1303. In recent years, however, the Commission staff has identified a number of disparate products—some intended for use by children and others simply used in or around the household or in recreation—that presented a risk of lead poisoning from sources other than paint. These products included vinyl miniblinds, crayons, figurines used as game pieces, and children's jewelry. (3) In several of these cases, the staff's determination that the products presented a risk of lead poisoning resulted in recalls or in the replacement of those products with substitutes, in addition to an agreement to discontinue the use of lead in future production. The Commission believes that, had the manufacturers of these lead-containing products acted with prudence and foresight before introducing the products into commerce, they would not have used lead at all. This in turn would have eliminated both the risk to young children and the costs and other consequences associated with the corrective actions. (4) The Commission urges manufacturers to eliminate lead in consumer products to avoid similar occurrences in the future. However, to avoid the possibility of a Commission enforcement action, a manufacturer who believes it necessary to use lead in a consumer product should perform the requisite analysis before distribution to determine whether the exposure to lead causes the product to be a “hazardous substance.” If the product is a hazardous substance and is also a children's product, it is banned. If it is a hazardous household substance but is not intended for use by children, it requires precautionary labeling. This same type of analysis also should be performed on materials substituted for lead. (5) The Commission also notes that, under the FHSA, any firm that purchases a product for resale is responsible for determining whether that product contains lead and, if so, whether it is a “hazardous substance.” The Commission, therefore, recommends that, prior to the acquisition or distribution of such products, importers, distributors, and retailers obtain information and data, such as analyses of chemical composition or accessibility, relevant to this determination from manufacturers, or have such evaluations conducted themselves. [63 FR 70649, Dec. 22, 1998] § 1500.231 Guidance for hazardous liquid chemicals in children's products. (a) Summary. 1 1 (b) Hazard. (c) Guidance. (2) The Commission's staff has identified a number of liquid-filled children's products, such as rolling balls, bubble watches, necklaces, pens, paperweights, maze toys, liquid timers, and keychains, that contain hazardous chemicals. In several of these cases, the staff determined that these products violated the FHSA because they presented a risk of chemical poisoning and/or chemical pneumonia from aspiration. This determination resulted in recalls or in the replacement of those products with substitutes, as well as in agreements with the manufacturers to discontinue the use of hazardous chemicals in liquid-filled children's products in future production. The Commission believes that these hazardous substances pose a risk to young children and, consequently, manufacturers should not have included them in the product design or manufacturing process. (3) Therefore, the Commission considers the use of hazardous chemicals in children's products such as those described above to be ill-advised and encourages manufacturers to avoid using them in such products. Further, the Commission recommends that, before purchasing such products for resale, importers, distributors, and retailers obtain assurances from the manufacturers that liquid-filled children's products do not contain hazardous liquid chemicals. [63 FR 70648, Dec. 22, 1998] § 1500.232 Statement on animal testing policy. (a) Summary. (2) In order to determine the appropriate cautionary labeling, it is necessary to have objective criteria by which the existence of each hazard can be determined. Hazards such as toxicity, tissue corrosiveness, eye irritancy, and skin irritancy result from the biological response of living tissue and organs to the presence of the hazardous substance. One means of characterizing these hazards is to use animal testing as a proxy for the human reaction. In fact, the FHSA defines the hazard category of “highly toxic” in terms of animal toxicity when groups of 10 or more rats are exposed to specified amounts of the substance. The Commission's regulations under the FHSA concerning toxicity and irritancy allow the use of animal tests to determine the presence of the hazard when human data or existing animal data are not available. (3) Neither the FHSA nor the Commission's regulations requires animal testing. The FHSA and its implementing regulations only require that a product be labeled to reflect the hazards associated with that product. If animal testing is conducted, Commission policy supports limiting such tests to a minimum number of animals and advocates measures that eliminate or reduce the pain or discomfort to animals that can be associated with such tests. The Commission has prepared this statement of policy with respect to animal testing to encourage the manufacturers subject to the FHSA to follow a similar policy. (4) In making the appropriate hazard determinations, manufacturers of products subject to the FHSA should use existing alternatives to animal testing whenever possible. These include: prior human experience ( e.g., in vitro in silico e.g., e.g., http://www.cpsc.gov/library/animaltesting.html. e.g., (b) Statement of policy on animal testing. http://www.cpsc.gov/library/animaltesting.html. http://www.cpsc.gov/library/animaltesting.html. (i) Acute toxicity. in vitro in vivo in vitro in silico http://www.cpsc.gov/library/animaltesting.html (A) In vitro in vivo (B) Valid in vitro in vivo (C) A sequential version of the traditional LD50/LC50 tests described in § 1500.3(c)(1) and (2) and the test method described in § 1500.40, in which dose groups are run successively rather than simultaneously; (D) A limit-dose test where the LD50/LC50 is determined as a point estimate, which can still be used to categorize a hazard, although it gives no information on hazard dose-response. In the limit test, animals (10 rats) each receive a single dose of product at 5g per kilogram of body weight. If not more than one animal dies in 14 days, the product is considered to have an LD50 of greater than 5g/kg, and thus, deemed to be nontoxic. Only if two or more animals die is a second group of 10 rats tested (at a lower dose). This procedure reduces the number of animals tested from the 80 to 100 animals involved in a full LD50 test to, typically, 10 to 20 rats per product. This reduction in the number of animals tested is justified because an exact LD50 is not required by either the FHSA or the regulations. The FHSA requires only a categorical determination that the toxicity is greater than 5g/kg, between 50 mg/kg and 5g/kg, or less than 50 mg/kg. (ii) Dermal irritation/corrosivity. in vitro in vivo in vitro in silico http://www.cpsc.gov/library/animaltesting.html in vitro, in vitro in vivo (A) In a tiered in vivo (B) If a tiered test is not feasible, the Commission recommends the test method described in § 1500.41. Note that in any in vivo (iii) Ocular irritation. in vivo in vitro in silico http://www.cpsc.gov/library/animaltesting.html (A) When the weight-of-evidence is insufficient to determine a substance's ocular irritation, a Commission-approved in vitro in silico in vitro http://www.cpsc.gov/library/animaltesting.html in vitro (B) If the dermal test strategy outlined in section paragraph (b)(1)(ii)(B) of this section leads to a conclusion of not corrosive, a tiered in vivo (C) When any ocular irritancy testing on animals is conducted, including the method described in § 1500.42, the Commission recommends a threefold plan to reduce animal suffering: The use of preemptive pain management, including topical anesthetics and systemic analgesics that eliminate or reduce suffering that may occur as a result of the application process or from the test substance itself (an example of a typical preemptive pain treatment is two applications of tetracaine ophthalmic anesthetic, 10-15 minutes apart, prior to instilling the test material to the eye); post-treatment with systemic analgesics for pain relief; and implementation of humane endpoints, including scheduled observations, monitoring, and recording of clinical signs of distress and pain, and recording the nature, severity, and progression of eye injuries. The specific techniques that have been approved by the Commission can be found at: http://www.cpsc.gov/library/animaltesting.html. (iv) Dermal sensitization. in vitro in vitro http://www.cpsc.gov/library/animaltesting.html in vivo in vitro in silico (2) [Reserved] [77 FR 73288, Dec. 10, 2012] Imports § 1500.265 Imports; definitions. For the purposes of the regulations prescribed under section 14 of the act: (a) The term owner or consignee (b) The term area office director § 1500.266 Notice of sampling. When a sample of a hazardous substance offered for import has been requested by the director of the area office, the collector of customs having jurisdiction over the hazardous substance shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such hazardous substance and not distribute it until further notice from the area office director or the collector of customs of the results of examination of the sample. § 1500.267 Payment for samples. The Consumer Product Safety Commission will pay for all import samples that are found to be in compliance with the requirements of the act. Billing for reimbursement should be made by the owner or consignee to the Commission area office headquarters in the territory of which the shipment was offered for import. Payment for samples will not be made if the hazardous substance is found to be in violation of the act, even though subsequently brought into compliance under the terms of an authorization to bring the article into compliance. § 1500.268 Hearing. (a) If it appears that the hazardous substance may be subject to refusal of admission, the area office director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request, giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the hazardous substance, and may be introduced orally or in writing. (b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the hazardous substance into compliance with the act, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the area office director shall specify a time limit, reasonable in the light of the circumstances, for filing such application. § 1500.269 Application for authorization. Application for authorization to relabel or perform other action to bring the hazardous substance into compliance with the act may be filed only by the owner or consignee and shall: (a) Contain detailed proposals for bringing the article into compliance with the act. (b) Specify the time and place where such operations will be carried out and the approximate time for their completion. § 1500.270 Granting of authorization. (a) When authorization contemplated by § 1500.269 is granted, the area office director shall notify the applicant in writing, specifying: (1) The procedure to be followed: (2) That the operations are to be carried out under the supervision of an officer of the Consumer Product Safety Commission or the Bureau of Customs, as the case may be; (3) A time limit, reasonable in the light of the circumstances, for completion of the operations; and (4) Such other conditions as are necessary to maintain adequate supervision and control over the article. (b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the area office director may grant such additional time as he deems necessary. (c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the area office director. (d) If ownership of a hazardous substance covered by an authorization changes before the operations specified in the authorization have been completed, the original owner will be held responsible, unless the new owner has executed a bond and obtained a new authorization. Any authorization granted under this section shall supersede and nullify any previously granted authorization with respect to the article. § 1500.271 Bonds. (a) The bonds required under section 14(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the hazardous substance into compliance with the act in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with the collector of customs. (b) The collector of customs may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but the collector shall not act under this regulation in any case unless the area office director is in full agreement with the action. § 1500.272 Costs chargeable in connection with relabeling and reconditioning inadmissible imports. The cost of supervising the relabeling or other action necessary in connection with an import of a hazardous substance that fails to comply with the act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursuant to section 14(b) of the act. The cost of such supervision shall include, but not be restricted to, the following: (a) Travel expenses of the supervising officer. (b) Per diem in lieu of subsistence of the supervising officer when away from his home station as provided by law. (c) Services of the supervising officer, to be calculated at the rate of a GS 11, step 1 employee, except that such services performed by a customs officer and subject to the provisions of the Act of February 13, 1911, as amended (sec. 5, 36 Stat. 901 as amended; 19 U.S.C. 267), shall be calculated as provided in that Act. (d) Services of the analyst, to be calculated at the rate of a GS 12, step 1 employee (which shall include the use of the chemical laboratories and equipment of the Consumer Product Safety Commission). (e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1 hour, and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than one-half hour. [38 FR 27012, Sept. 27, 1973, as amended at 57 FR 28605, June 26, 1992]

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