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. (a) Toys and other articles presenting mechanical hazards. The torque or maximum rotation shall be maintained for an additional 10 seconds. 369.7 Warnings required by official compendia. How safe Eisai Co. and Biogen Inc. 's Alzheimer's drug is for patients will depend on whether physicians adequately heed the FDA's warnings of potential brain swelling and bleeding, clinicians and researchers say. The size of cautionary labeling shall be reasonably related to the type size of any other printing appearing on the same panel, but in any case must meet the minimum size requirements in table 1. (xi) Toy smoke devices and flitter devices. The toy shall be dropped in random orientation. (2) Impact medium. [3] When using the tester, it will be found that the indicator light may not illuminate and the temperature may not rise until a temperature control dial setting between one and two is reached. (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. The Commission estimates that the removal of large reloadable shells from the market is likely to virtually eliminate the number of associated injuries, with only a slight offsetting increase in the number of injuries due to the use of substitute Class C fireworks products available to consumers. (iii) Spike and handle cylindrical fountains. This category is comparable to the one termed Probable Positive in the EPA guidelines on male reproductive risk assessment. 147176)). 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. Oral ingestion studies may involve direct monitoring of sources of chemicals as well as laboratory simulations. Accordingly, the Commission finds that the benefits from the regulation bear a reasonable relationship to its costs. 2), of molded clear glass, annealed, heat-resistant, and free from surface defects. (a) When authorization contemplated by 1500.269 is granted, the area office director shall notify the applicant in writing, specifying: (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. Place so that the bottom of the bulb is [6] The target temperature may be attained by originally turning the coarse temperature control knob to the proper setting (see 1500.43a(h)(1) for the temperature desired rather than the maximum setting (full on). 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. noun Definition of warning 1 as in caution the act or an instance of telling beforehand of danger or risk she delivered a strict warning that anyone who was caught stealing would be fired Synonyms & Similar Words Relevance caution forewarning alert advice recommendation admonishment admonition suggestion heads-up notice alarm prediction informing The clamp shall be capable of holding the test component firmly and transmitting a torsional force. Background and more details are available in the Adjust the test flame with the pinch valve to conform to the size of the 4-mm (5/32-in.) 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. 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. A sharp point tester of the general configuration shown in figure 1 of this section or one yielding equivalent results shall identify a sharp point. Instructions for Downloading Viewers and Players, INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE. (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. (6) Package or packaging refers to the immediate package in which a product subject to labeling under section 24 of the act is sold, as well as to any outer container or wrapping for that package. A banning rule would be more effective than case-by-case recalls because the impalement hazard affects all dive sticks, not a specific brand or model. The temperature of the sample at the time of testing shall be between 68 F. Use only in well-ventilated area. (3) For tests where the expected flashpoint is above ambient. Any cautionary statement required by section 1500.19(b) may be displayed on a display panel of the package of a product subject to the labeling requirement other than the principal display panel only if: (1) The package has a principal display panel of 15 square inches or less, (2) The full labeling statement required by paragraph (b) of this section is displayed in three or more languages on another display panel of the package of the product, and. Any metal or glass edge that is accessible either before or after the test of 1500.51, 1500.52, and 1500.53 (excluding the bite testparagraph (c) of each section) are performed shall be subject to the sharp edge test of paragraph (d) of this section. The instrument power switch is to be in the off position. In the case of a product subject to the labeling requirements of 1500.19(b) which is manufactured outside the United States and is shipped directly from the manufacturer to the consumer by United States mail or other delivery service in an immediate package that contains descriptive material, the descriptive material inside the immediate package of the product need not bear the required labeling statement only if the shipping container of the product contains other accompanying material that bears the required statements displayed in a prominent and conspicuous manner. a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. (1) Principle of operation. (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. (i) General. (iii) separate explanatory literature available on requirements at the point of purchase. (9) The information described in paragraph (b)(8)(i)(E) of this section must appear on: (i) The outside container or wrapper, if any, unless it is easily legible through the outside container or wrapper and, (ii) All accompanying literature where there are directions for use, written or otherwise. If the full mandrel force of 1.35 pounds (6.00 Newtons) causes the edge to bend, a reduced mandrel force may be used. The adverse health effects of these chemicals to children include chemical poisoning from ingestion of the chemicals, pneumonia from aspiration of the chemicals into the lungs, and skin and eye irritation from exposure to the chemicals. 1262(e)(1); 15 U.S.C. 1 CFR 1.1 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). [40 FR 1483, Jan. 7, 1975; 40 FR 16191, Apr. To satisfy the requirement of the Act that cautionary labeling statements shall appear prominently on the label of a hazardous substance, all such statements shall be placed on the label as follows: (1) Horizontal placement of labeling statements. The specific type and frequency of behavior that a child exposed to a product will exhibit depends on the age of the child and the characteristics and pattern of use of the product. (6) Combined StatementIf 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. Factors the Commission would consider in making this determination are how an item is packaged (e.g., packages of multiple colored pencils, chalks, or markers unless promoted for non-art materials uses are likely to be art materials), how it is marketed and promoted (e.g., pencils and pens intended specifically for sketching and drawing are likely to be art materials), and where it is sold (e.g., products sold in an art supply store are likely to be art materials). Substances are also toxic by reason of their probable neurotoxicity when they meet the limited evidence criteria of neurotoxicity in humans, or the sufficient evidence criteria derived from animal studies. Some examples of such statements are HARMFUL OR FATAL IF SWALLOWED, VAPOR HARMFUL, FLAMMABLE, and SKIN AND EYE IRRITANT.. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits in children's products. The following parts of this section outline some of these alternatives. Also bearing on the effectiveness of a warning might be the effect of the package contents if spilled on the label. A 15-pound 0.5 pound (6.80-kilogram) direct force shall be evenly applied, within a period of 5 seconds, parallel to the major axis of the test component and maintained for an additional 10 seconds. CANCER AGENT BASED ON TESTS WITH LABORATORY ANIMALS. Toxic also applies to any substance that can be labeled as such, based on the outcome of any of the approved test methods described in the CPSC's animal testing policy set forth in 1500.232, including data from in vitro or in silico test methods that the Commission has approved; or a validated weight-of-evidence analysis comprising all of the following that are available: Existing human and animal data, structure activity relationships, physicochemical properties, and chemical reactivity data. (1) Limited form for use on invoice or bill of sale. However, in the case of a product that contains a balloon and another item subject to the labeling requirements, only the signal word and statement of hazard may be combined. The Tag open-cup tester is illustrated in Fig. Toxic applies to any substance that is toxic (but not highly toxic) on the basis of human experience. 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. 18-inch below the edge, as determined by the leveling device. (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. The label of any drug listed as a "controlled substance" in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.". 120733 (15 U.S.C. Immediately apply the test flame as detailed. This will provide benefits of saving one life about every 3 years, and preventing an unknown number of nonfatal injuries. (b) Procedure. (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. (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 cost of such supervision shall include, but not be restricted to, the following: (a) Travel expenses of the supervising officer. The Occupational Safety and Health Administration (OSHA) has not yet developed any classification for developmental toxicity. In the following table are given the dimensions of sleeves and the approximate body surface exposed to the test substance. Avoid prolonged or repeated contact with skin. Upon request of the Commission, a producer or repackager shall submit to the Commission product formulations. (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. (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. Under the Consumer Product Safety Improvement Act of 2008, Public Law 110314, 122 Stat. (2) Method BFinite (or Actual) Flashpoint. (i) Limited evidence of neurotoxicity in humans. It is reasonable, for practical purposes, to regard an agent for which there is sufficient evidence of carcinogenicity in animals as if it presented a carcinogenic risk to humans. per minute. (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. 2283 0 obj <>stream (i) For any hole, recess, or opening having a minor dimension (The minor dimension of an opening is the diameter of the largest sphere that will pass through the opening.) 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). (ii) The Child Protection and Toy Safety Act of 1969 (Pub. Subpart A - Definitions and Interpretations. (3) Testing procedure. A practical equivalent may be substituted for the statement Keep out of the reach of children.. The toy shall be secured in a vise equipped with vise shields that are fabricated from 13-gauge cold-rolled steel or other similar material and that have a 0.375-inch (0.95-centimeter) inside radius. (Sec. A ball is permanently enclosed if, when tested in accordance with 16 CFR 1500.52, the ball is not removed from the outer container. The lids are then gently held together for one second and the animal is released. (9) Boston Billow Nursing Pillow and substantially similar nursing pillows that are designed to be used only as a nursing aide for breastfeeding mothers. The Commission considered the following alternatives: no action; labeling all metal-cored candles with wicks containing more than 0.06 percent lead by weight of the metal; recordkeeping for shipments of wicks containing 0.06 percent or less lead by weight of the metal and of candles with such wicks; and relying on the voluntary standard. (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.
How Many Us Casualties Ww2,
National Museum Of The Pacific War Fredericksburg, Tx,
Articles F
