Source: https://www.law.cornell.edu/cfr/text/16/1500.14
Timestamp: 2017-02-21 12:25:49
Document Index: 495061391

Matched Legal Cases: ['art 1500', '§ 1500', '§ 1500', '§ 1500', '§ 1500', '§ 1500', 'art 1507', '§ 1500', '§ 1500', '§ 1500', '§ 1500', '§ 1500', '§ 1500', '§ 1500']

16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act. | US Law | LII / Legal Information Institute
CFR › Title 16 › Chapter II › Subchapter C › Part 1500 › Section 1500.14 16 CFR 1500.14 - Products requiring special labeling under section 3(b) of the act.
§ 1500.14 Products requiring special labeling under section 3(b) of the act.
(1)Diethylene glycol. Because diethylene glycol and mixtures containing 10 percent or more by weight of diethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, such products shall be labeled with the signal word “warning” and the statement “Harmful if swallowed.”
(2)Ethylene glycol. Because ethylene glycol and mixtures containing 10 percent or more by weight of ethylene glycol are commonly marketed, stored, and used in a manner increasing the possibility of accidental ingestion, such products shall be labeled with the signal word “warning” and the statement “Harmful or fatal if swallowed.”
(3)Benzene, toluene, xylene, petroleum distillates.
(i) Because inhalation of the vapors of products containing 5 percent or more by weight of benzene may cause blood dyscrasias, such products shall be labeled with the signal word “danger,” the statement of hazard “Vapor harmful,” the word “poison,” and the skull and crossbones symbol. If the product contains 10 percent or more by weight of benzene, it shall bear the additional statement of hazard “Harmful or fatal if swallowed” and the additional statement “Call physician immediately.”
(4)Methyl alcohol (methanol). Because death and blindness can result from the ingestion of methyl alcohol, the label for this substance and for mixtures containing 4 percent or more by weight of this substance shall include the signal word “danger,” the additional word “poison,” and the skull and crossbones symbol. The statement of hazard shall include “Vapor harmful” and “May be fatal or cause blindness if swallowed.” The label shall also bear the statement “Cannot be made nonpoisonous.”
(5)Turpentine. Because turpentine (including gum turpentine, gum spirits of turpentine, steam-distilled wood turpentine, sulfate wood turpentine, and destructively distilled wood turpentine) and products containing 10 percent or more by weight of such turpentine, in addition to oral toxicity resulting in systemic poisoning, may be aspirated into the lungs with resulting chemical pneumonitis, pneumonia, and pulmonary edema, such products shall be labeled with the signal word “danger” and the statement of hazard “Harmful or fatal if swallowed.”
(6)Charcoal. Charcoal briquettes and other forms of charcoal in containers for retail sale and intended for cooking or heating.
(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:
(A) Because inhalation of the carbon monoxide produced by burning charcoal indoors or in confined areas can cause serious injury or death, containers of such products packaged on or after November 3, 1997, shall bear the following borderlined label.
(B) Except as provided in paragraph (b)(6)(ii)(C) of this section, the following requirements apply to bags of charcoal subject to paragraph (b)(6)(ii)(A) of this section. The label specified in paragraph (b)(6)(ii)(A) of this section shall appear within a heavy borderline, in a color sharply contrasting to that of the background, on both the front and back panels in the upper 25 percent of the panels of the bag, and with the outer edge of the borderline at least 2.54 cm (1 inch) below the seam and at least 2.54 cm (1 inch) above any other reading material or design elements. The signal word “WARNING” shall be in bold capital letters in at least 7.14 mm (
9/32 inch) type. The remaining text of the warning statement shall be in at least 4.763 mm (
3/16 inch) type. The phrase “CARBON MONOXIDE HAZARD” shall be in bold. This phrase and the word “NEVER” shall be in all capital letters. The lettering shall have a strokewidth-to-height ratio of 1:6 to 1:8. The label shall be at least 50.8 mm (2 inches) high and 147.5 mm (5
13/16 inches) wide. The label's lettering, spacing between the bottom of the letters of one line and the top of the letter of the next line, and pictogram shall have the size relation to each other and to the remainder of the label shown in paragraph (b)(6)(ii)(A) of this section.
(7)Fireworks devices. Because of the special hazards presented by fireworks devices if not used in a certain manner, the following listed fireworks devices shall be labeled as indicated:
(i)Fountains.
(ii)California candles.
(iii)Spike and handle cylindrical fountains.
(A)Spike fountains.
(B)Handle fountains.
Hold in hand - point away from body.
(iv)Roman Candles.
(v)Rockets with sticks.
(vi)Wheels.
(vii)Illuminating torches.
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).
(viii)Sparklers.
(ix)Mines and shells.
(x)Whistles without report.
(xi)Toy smoke devices and flitter devices.
(xii)Helicopter-type rockets.
(xiii)Party poppers.
Hold in hand - jerk string.
(xiv)Missile-type rockets.
(xv)Labeling - General. Any fireworks device not required to have a specific label as indicated above shall carry a warning label indicating to the user where and how the item is to be used and necessary safety precautions to be observed. All labels required under this section shall comply with the requirements of § 1500.121 of these regulations. (See also § 1500.17(a) (3), (8) and (9); § 1500.83(a)(27); § 1500.85(a)(2); and part 1507).
(8)Art materials.
The Labeling of Hazardous Art Materials Act (“LHAMA”), 15 U.S.C. 1277 (Pub. L. 100-695, enacted November 18, 1988) provides that, as of November 18, 1990, “the requirements for the labeling of art materials set forth in the version of the standard of the American Society for Testing and Materials [“ASTM”] designated D-4236 that is in effect on [November 18, 1988] * * * shall be deemed to be a regulation issued by the Commission under section 3(b)” of the Federal Hazardous SubstancesAct, 15 U.S.C. 1262(b). For the convenience of interested persons, the Commission is including the requirements of ASTM D-4236 in paragraph (b)(8)(i) of this section, along with other requirements (stated in paragraph (b)(8)(ii) of this section) made applicable to art materials by the LHAMA. The substance of the requirements specified in LHAMA became effective on November 18, 1990, as mandated by Congress.
(i)ASTM D-4236 - (A)Scope - (1) This section describes a procedure for developing precautionary labels for art materials and provides hazard and precautionary statements based upon knowledge that exists in the scientific and medical communities. This section concerns those chronic health hazards known to be associated with a product or product component(s), when the component(s) is present in a physical form, volume, or concentration that in the opinion of a toxicologist (see paragraph (b)(8)(i)(B)(11) of this section) has the potential to produce a chronic adverse health effect(s).
(B) Descriptions of Terms Specific to This Standard. (1) Art material or art material product - any raw or processed material, or manufactured product, marketed or represented by the producer or repackager as intended for and suitable for users as defined herein.
(2) Users - artists or crafts people of any age who create, or recreate in a limited number, largely by hand, works which may or may not have a practical use, but in which aesthetic considerations are paramount.
(3) Chronic adverse health effect(s) - a persistent toxic effect(s) that develops over time from a single, prolonged, or repeated exposure to a substance. This effect may result from exposure(s) to a substance that can, in humans, cause sterility, birth defects, harm to a developing fetus or to a nursing infant, cancer, allergenic sensitization, damage to the nervous system, or a persistent adverse effect to any other organ system.
(4) chronic health hazard(s) (hereafter referred to as “chronic hazard”) - a health risk to humans, resultant from exposure to a substance that may cause a chronic adverse health effect.
(5) Analytical laboratory - a laboratory having personnel and apparatus capable of performing quantitative or qualitative analyses of art materials, which may yield information that is used by a toxicologist for evaluation of potentially hazardous materials.
(6)Label - a display of written, printed, or graphic matter upon the immediate container of any art material product. When the product is unpackaged, or is not packaged in an immediate container intended or suitable for delivery to users, the label can be a display of such matter directly upon the article involved or upon a tag or other suitable labeling device attached to the art material.
(7) Producer - the person or entity who manufactures, processes, or imports an art material.
(8) Repackager - the person or entity who obtains materials from producers and without making changes in such materials puts them in containers intended for sale as art materials to users.
(9)Sensitizer - a substance known to cause, through an allergic process, a chronic adverse health effect which becomes evident in a significant number of people on re-exposure to the same substance.
(10)Toxic - applies to any substance that is likely to produce personal injury or illness to humans through ingestion, inhalation, or skin contact.
(11) Toxicologist - an individual who through education, training, and experience has expertise in the field of toxicology, as it relates to human exposure, and is either a toxicologist or physician certified by a nationally recognized certification board.
(12) Bioavailability - the extent that a substance can be absorbed in a biologically active form.
(7) Statement of Conformance - “Conforms to ASTM Practice D-4236,” or “Conforms to ASTM D-4236,” or “Conforms to the health requirements of ASTM D-4236.” This statement may be combined with other conformance statements. The conformance statement should appear whenever practical on the product; however, it shall also be acceptable to place the statement on one or more of the following:
(E) Labeling Practices - (1) Signal Word. (i) When a signal word for an acute hazard(s) is mandated and a chronic hazard(s) exists, the signal word shall be that for the acute hazard.
(2) List of Potentially Chronic Hazards - Potentially chronic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be stated substantially in accordance with the statements listed in paragraph (b)(8)(i)(F) of this section. Potentially chronic hazards noted shall be those that are clinically significant and that might be expected with any reasonably foreseeable use of the art material. The hazards should be grouped in the order of relative descending severity.
(3) Name of Chronically Hazardous Component(s) - All components and known decomposition products of the formulation with a potential for chronic hazards, as determined under the procedures of paragraph (b)(8)(i)(D) of this section, shall be listed prominently. Generically equivalent names may be used.
(4) Safe Handling Instructions - Appropriate precautionary statements as to work practices, personal protection, and ventilation requirements shall be used substantially conforming with those listed in paragraph (b)(8)(i)(G) of this section.
(5) List of Sensitizing Components - To protect users from known sensitizers found within art materials, each label shall contain a list of those sensitizers present in sufficient amounts to contribute significantly to a known skin or respiratory sensitization.
(6) Combined Statement - If an art material contains more than one component capable of causing a chronic adverse health effect, or if a single chemical can cause several different chronic adverse health effects, the potential effects may be combined into one statement.
(7) Information Sources - The precautionary label shall contain a statement identifying a source for additional health information substantially in conformance with one of the phrases listed below:
(i) For more health information - (24 hour cost-free U.S. telephone number),
(8) Labeling Content, Product Size - Any art material product in a container larger in size than one fluid ounce (30 ml) (if the product is sold by volume) or one ounce net weight (28 g) (if the product is sold by weight) shall have full precautionary labeling, as described in paragraph (b)(8)(i) (E) of this section. Any art material product in a container equal to or smaller than one fluid ounce or one ounce net weight shall have a label that includes a signal word in conformance with paragraph (b)(8)(i)(E)(1) of this section and a list of potentially harmful or sensitizing components in conformance with paragraphs (b)(8)(i)(E) (3) and (5) of this section.
(11) Supplemental Information - Where appropriate, more detailed information that relates to chronic hazard(s), such as physical properties, decomposition products, detailed safety instructions, or disposal recommendations, shall be included in supplemental documents, such as Material Safety Data Sheets, technical brochures, technical data sheets etc.
(ii) The following shall apply with respect to the standard for art materials set forth in § 1500.14(b)(8)(i).
(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).
(iii) Pursuant to the LHAMA, the Commission has issued guidelines which, where possible, specify criteria for determining when any customary or reasonably foreseeable use of an art material can result in a chronic hazard. These guidelines include criteria for determining when art materials may produce chronic adverse effects in children and adults, criteria for determining which substances contained in art materials have the potential for producing chronic adverse effects and what those effects are, criteria for determining the bioavailability of chronically hazardous substances contained in art materials when the products are used in a customary or reasonably foreseeable manner, and criteria for determining acceptable daily intake levels for chronically hazardous substances contained in art materials. Because these guidelines apply to hazardous substances in general as well as to hazardous substances in art materials, the guidelines are set forth in § 1500.135 and a definition of “chronic toxicity” is provided in § 1500.3(c)(2)(ii) as part of supplementation of the term “toxic” in section 2(q) of the FHSA.
(iv)Policies and interpretations.
(A) For purposes of enforcement policy, the Commission will not consider as sufficient grounds for bringing an enforcement action under the Labeling of Hazardous Art Materials Act (“LHAMA”) the failure of the following types of products to meet the requirements of § 1500.14(b)(8) (i) through (iii).
(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 SubstancesAct (“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)(8) - Guidelines for a Certifying Organization (Not Mandatory)
16 CFR 1500.133 — Extremely Flammable Contact Adhesives; Labeling.
16 CFR 1112.31 — Who Is Subject to These Audit Requirements?
16 CFR 1507.7 — Handles and Spikes.