(7) Producerthe person or entity who manufactures, processes, or imports an art material. (B) From just above the water surface, drop the dive stick into the container. (ii) Significant potential for causing hypersensitivity. (A) Human Data. Products declared to be hazardous substances under section 3(a) of the act. 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. The weight-of-evidence analysis should incorporate any existing data on humans and animals, validated in vitro or in silico test results, and any relevant physicochemical properties that indicate the substance might be a dermal sensitizer. (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 test equipment consists of a base 8 inches wide, 2 feet long, marked in 6-inch intervals. [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]. 30(a), 86 Stat. Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing. The Commission considered several alternatives to the ban. After the thermometer mercury column ceases to advance, record the dial reading and the temperature. These effects include neurological damage, delayed mental and physical development, attention and learning deficiencies, and hearing problems. [A description of the location of the other panel is to be inserted in the blank space. The elapsed time to reach the temperature will be greater, except for maximum temperature. This web site is designed for the current versions of The sleeve is slipped onto the animal which is then placed in a comfortable but immobilized position in a multiple animal holder. 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. (vi) Flammable solid means a solid substance that, when tested by the method described in 1500.44, ignites and burns with a self-sustained flame at a rate greater than one-tenth of an inch per second along its major axis. (ii) Specifications for ispropanol, flash point check grade. FDA is responsible for: Protecting the public health by ensuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; Ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) 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. If abbreviated cautionary statements are used: (1) The full cautionary statements associated with the abbreviated cautionary statements shall appear: (i) Near the beginning of the catalogue, before any catalogue pages that contain advertisements of products available for purchase, or. What are benzodiazepines? Although a voluntary standard relating to the risk of injury associated with reloadable tube aerial shells has been adopted, it has not been implemented. (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. (8) Irritant means any substance not corrosive within the meaning of section 2(i) of the act (restated in paragraph (b)(7) of this section) which on immediate, prolonged, or repeated contact with normal living tissue will induce a local inflammatory reaction. L. 91113, 83 Stat. (See also 1500.14(b)(7); 1500.17(a) (3), (8) and (9); and part 1507). (ii) Sufficient evidence of carcinogenicity in animals. Resume heating, and pass the taper flame across the sample at two intervals of 2 F.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration Occasionally, particularly near actual flashpoint, the application of the test flame will cause a halo or an enlarged flame; this is not a flash and should be ignored. When such data give reliable results different from results with animal data, the human experience takes precedence. (3) Set the instrument at the target temperature. (1) General. (i) A specified voume of sample is introduced into the cup of the apparatus that is maintained at the expected flashpoint. (e) Collapsible metal tubes. Any area on the surface of a toy that is accessible to a child and inaccessible to flat-surface contact during the impact test shall be subject to this test. (ii) Toys with rotating components. Use only under [close] adult supervision. If such an approach is adopted, it will apply here. 2(f)(1), (A), (B), (g), (q)(1)(B), 3(a), 74 Stat. (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. 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. In the following table are given the dimensions of sleeves and the approximate body surface exposed to the test substance. (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. 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. Keep burning end or sparks away from wearing apparel or other flammable material. 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. (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. (i) General. Remove the sample and clean the instrument. The instruction to read additional warnings must comply with the size, placement, conspicuousness, and contrast requirements of 1500.121; and. Turn the coarse temperature control knob fully clockwise (full on) causing the indicator light to illuminate. (See paragraph (e) of this section.). (c)(6)(i) Extremely flammable means any substance that has a flashpoint at or below 20 F. 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. If the full mandrel force of 1.35 pounds (6.00 Newtons) causes the edge to bend, a reduced mandrel force may be used. (d) Conspicuousnesscontrast. 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. (2) Test apparatus. (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. Examples of Commission-validated in vitro assays are identified on the Commission's animal testing Web site at: http://www.cpsc.gov/library/animaltesting.html). (4) Such other conditions as are necessary to maintain adequate supervision and control over the article. 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. (a) Objective. The effective date of paragraphs (a)(6)(i)(A) and (a)(6)(ii)(A) was stayed by an order published in the Federal Register of August 10, 1972 (37 FR 16078). [38 FR 27012, Sept. 27, 1973, as amended at 57 FR 28605, June 26, 1992]. Use an absorbent paper tissue to wipe clean, if necessary. For flashpoints from 20 F. Use (specify type) local exhausting hood. (3) Contain the name and address, and e-mail address or telephone number, of the requestor.
January - March 2023 | Potential Signals of Serious Risks/New Safety The metric approximations are provided in parentheses for convenience and information only. [38 FR 27012, Sept. 27, 1973, as amended at 68 FR 19147, Apr. (xv) LabelingGeneral. For Federal Register citations affecting 1500.18, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. The clamp shall be capable of holding the test component firmly and transmitting a torsional force. 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. Terms are listed alphabetically in the table below. (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. A small test flame is passed at a uniform rate across the cup at specified intervals. There is the possibility that this factor may be changed, using the 14 power instead of the 13 power, as part of a unified Federal regulatory approach. Data from in vitro or in silico test methods that have not been approved by the Commission may be submitted to the Commission for consideration of their acceptability. (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. Charcoal briquettes and other forms of charcoal in containers for retail sale and intended for cooking or heating. 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. The Commission, on its own initiative or upon petition by an interested party, shall grant an exception to the limit under paragraph (a) of this section for a specific product, class of product, material, or component part if the Commission, after notice and a hearing, determines that: (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. Organization and Purpose 2079(a))), A substance may be toxic due to a risk of a chronic hazard. The sleeves may vary in size to accommodate smaller or larger subjects. (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. The price of the specification and amendment is $1.00. (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. (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. (1) Assessment of Exposure. With the availability of substitutes and the expected low cost of modifying dive sticks to conform to the rule, the Commission anticipates that necessary changes will be minimal. (b) Run water, brine, or water-glycol solution into the bath to a predetermined level, which will fill the bath to (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. 105556, as amended 70 Stat. (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. (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. (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. (h) Adjust heater source under bath so that the temperature of the sample increases at a rate of 20.5 F. (4) The Commission urges manufacturers to eliminate lead in consumer products to avoid similar occurrences in the future. If not separated by that distance, the labeling statements must be surrounded by a border line. For flashpoints above 40 F., use the ASTM Tag Closed Tester Thermometer, range of + 20 to + 230 F., in 1 F. Keep out of the reach of children.. 5, 36 Stat. 26, 1996; 61 FR 18245, Apr. (d) Carbolic acid (C6 H5 OH), also known as phenol, and any preparation containing carbolic acid in a concentration of 5 percent or more. The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not. The term does not include industrial supplies that might be taken into a home by a serviceman. Substances are toxic by reason of their carcinogenicity when they meet the sufficient evidence criteria of carcinogenicity from studies in humans, which require that a causal relationship between exposure to an agent and cancer be established. (a) Certain terms used in this part. 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. The first approved drug to slow the progression of the illness will come with a strong safety warning about potentially life-threatening side effects. (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: (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: (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. If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below. (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. These findings are discussed in paragraphs (a)(13)(iii)(B) through (D) of this section. The test surface shall have a hardness no less than 40 as measured on the Rockwell C scale, as determined pursuant to ASTM E 1874 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. (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. Federal Hazardous Substances Act Regulations, Hazardous Substances and Articles: Administration and Enforcement Regulations. The Commission will further evaluate points that are identified as presenting a potential risk of puncture or laceration injury to determine the need for individual product regulatory action. This area is not limited to the portion of the surface covered with labeling; rather, it includes the entire surface. Immediately apply the test flame as detailed. (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. (d) Other Subjects Related to the Determination that a Substance is Toxic. Lock the gaging cap in this position by rotating the lock ring until it fits firmly against the cap. (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. All statements of principal hazard or hazards on a label shall appear in the same size and style of type, and shall appear in the same color or have the same degree of boldness. For the convenience of interested persons, the Commission is including the requirements of ASTM D4236 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. (g) Acetic acid or any preparation containing free or chemically unneutralized acetic acid (HC2 H2 O2) in a concentration of 20 percent or more. The impact medium shall consist of a 18-inch (0.3-centimeter) nominal thickness of type IV vinyl-composition tile, composition 1asbestos free, as specified by paragraphs 1.2 and 3.1.4 of Interim Amendment-1(YD), dated November 14, 1979, to the Federal Specification entitled Tile, Floor: Asphalt, Rubber, Vinyl, Vinyl-Asbestos, SS-T-312B, dated October 10, 1974,1 over at least a 2.5-inch (6.4-centimeter) thickness of concrete. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. (ii) The fuel reservoir is designed to withstand a pressure of at least 112 times the maximum pressure which will be developed in the container at 120 F. (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. This category is similar to EPA's Group B, IARC's Group 2, or ANSI's Categories 2 and 3. (i) Known Human Developmental Toxicant (sufficient evidence in humans). (5) Small part means any object which, when tested in accordance with the procedures contained in 16 CFR 1501.4(a) and 1501.4(b)(1), fits entirely within the cylinder shown in Figure 1 appended to 16 CFR part 1501. (i) Acute toxicity. This category is also comparable to the category definitive evidence for human developmental toxicity proposed by EPA. Under the authority of section 2(f)(1)(D) of the act and pursuant to provisions of section 3(e) of the act, the Commission has determined that the following types of toys or other articles intended for use by children (not electrically operated) present an electrical hazard within the meaning of section 2(r) of the act. If there is any indication from this analysis that the substance is sensitizing to the skin, the substance should be labeled appropriately. 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. (3) Testing procedure. (2) that vomiting be induced using methods other than salt. (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. You are using an unsupported browser. (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: Do not puncture or incinerate container. 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. Warning Letter Procedures When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is the Food . If no NOEL can be determined, a safety factor of one thousand will be applied to the lowest LOEL. (ii) Oral Ingestion. 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 term marble does not include a marble permanently enclosed in a toy or game. (5) The producer or repackager shall supply a poison exposure management information source the generic formulation information required for dissemination to poison control centers or shall provide a 24-hour cost-free telephone number to poison control centers.
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