Title 16—Commercial Practices--Volume 1
PART 1500—HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND ENFORCEMENT REGULATIONS
§ 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. The sharp edge test method prescribed by paragraph (d) of this section will be used by the Commission in making a preliminary determination that metal or glass edges on toys and other articles intended for use by children under 8 years of age, and such edges exposed in normal use or as a result of reasonably forseeable damage or abuse of such toys and articles, present a potential risk of injury by laceration or avulsion under section 2(s) of the Federal Hazardous Substances Act (15 U.S.C. 1261(s)). The Commission will further evaluate toys and other articles with edges that are identified as presenting a potential risk of laceration or avulsion injury to determine the need for individual product regulation.
(b) Scope —(1) General. The sharp edge test of paragraph (d) of this section is applicable to toys or other articles containing metal or glass edges that are introduced into interstate commerce after March 26, 1979. Such articles manufactured outside the United States are introduced into interstate commerce when first brought within as U.S. port of entry. Such articles manufactured in the United States are introduced into interstate commerce (a) at the time of first interstate sale, or (b) at the time of first intrastate sale if one or more components and/or raw materials were received interstate, whichever occurs earlier.
(2) Exemptions. (i) Toys and other children's articles that are the subject of any of the following regulations are exempt from this § 1500.49: The regulations for bicycles, non-full-size baby cribs, and full-size baby cribs (parts 1508, 1509, and 1512 of this chapter).
(ii) Toys that by reason of their functional purpose necessarily present the hazard of sharp 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 —(i) Glass. For the purpose of this regulation the Commission defines glass as a hard, brittle, amorphous substance produced by fusion, usually consisting of mutually dissolved silica and silicates that also contain soda and lime.
(ii) Metal. For the purpose of this regulation the Commission intends the word metal to include both elemental metals and metal alloys.
(c) Accessibility —(1) General. 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 test—paragraph (c) of each section) are performed shall be subject to the sharp edge test of paragraph (d) of this section. 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.
(2) Accessible edges. (i) An accessible metal or glass edge for a toy or article intended for children 3 years of age or less is one that can be contacted by any portion forward of the collar of the accessibility probe designated as probe A in Figure 2 of this section.
(ii) An accessible 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. (i) For any hole, recess, or opening having a minor dimension (the minor dimension of an opening is the diameter of the largest sphere that will pass through the opening), smaller than the collar diameter of the appropriate probe, the total insertion depth for accessibility shall be up to the collar on the appropriate probe. Each probe joint may be rotated up to 90 degrees to simulate knuckle movement.
(ii) For any hole, recess, or opening having a minor dimension larger than the collar diameter of Probe A, but less than 7.36 inches (186.9 millimeters), when Probe A is used, or a minor dimension larger than the collar diameter of Probe B, but less than 9.00 inches (228.6 millimeters), when Probe B is used, the total insertion depth for accessibility shall be determined by inserting the appropriate probe with the extension, shown in Figure 2, in any direction up to 2 1/4 times the minor dimension of the hole, 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 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. Metal or glass edges shall be considered inaccessible without testing with a probe if they lie adjacent to a surface of the test sample, and any gap between the edge and the adjacent surface does not exceed 0.020 inch (0.50 millimeter) both before and after the tests of §§ 1500.51, 1500.52, and 1500.53 (excluding the bite test—paragraph (c) of each section) are performed. For example, in a lap joint in which a metal edge is overlapped by a parallel surface, any burr or feather-edge on the side closest to the protecting parallel surface is considered inaccessible if the gap between the edge and the parallel surface is no greater than 0.020 inch (0.50 millimeter). As an additional example, when sheet metal has a hemmed edge a portion of the sheet adjacent to the edge is folded back upon itself, approximately 180 degrees, so that it is roughly parallel to the main sheet. Any burrs or feathering on the inside edge, the side closest to the protecting parallel surface of the main sheet, will be considered inaccessible if the gap between the inside edge and the parallel surface does not exceed 0.020 inch (0.50 millimeter).
(d) Sharp edge test method —(1) Principle of operation. The test shall be performed with a sharp edge tester which contains a cylindrical mandrel capable of rotation at a constant velocity. (Engineering drawings for a suitable portable sharp edge test instrument are available from the Commission's Office of the Secretary.) The full circumference of the mandrel shall be wrapped with a single layer of polytetrafluoroethylene (TFE) tape as specified in paragraph (e)(3) of this section. The mandrel shall be applied to the edge to be tested with a normal force of 1.35 pounds (6.00 Newtons) such that the edge contacts the approximate center of the width of the tape as shown in Figure 1 of this section. The mandrel shall be rotated through one complete revolution while maintaining the force against the edge constant. Linear motion of the mandrel along the line of the edge shall be prevented. The edge shall be identified as sharp if it completely cuts through the tape for a length of not less than 1/2 inch (13 millimeters) at any force up to 1.35 pounds (6.00 Newtons).
(2) Procedure. (i) The edge of the sample to be tested shall be held in such a manner that it does not move during the test. If the full mandrel force of 1.35 pounds (6.00 Newtons) causes the edge to bend, a reduced mandrel force may be used.
(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 inch (13 millimeters) identifies an edge as sharp. (The test instruments used by the Commission in its test for compliance with the regulation will be calibrated to insure that the force with which the mandrel is applied to a test edge does not exceed 1.35 pounds.)
(e) Specifications for sharp edge test equipment. The following specifications shall apply to the equipment to be used in the sharp edge test described in paragraph (d) of this section:
(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 The adhesive shall be pressure-sensitive silicone polymer with a nominal thickness of 0.003 inch (.08 millimeter). The width of the tape shall not be less than 1/4 inch (6 millimeters). While conducting sharp edge tests the temperature of the tape shall be maintained between 70 °F (21.1 °C) and 80 °F (26.6 °C).
1 The tape that the Commission will use for the sharp edge test is CHR type “T” manufactured by The Connecticut Hard Rubber Co., New and East Streets, New Haven, Conn. 06509.
(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.
§ 1500.50   Test methods for simulating use and abuse of toys and other articles intended for use by children.
(a) Objective. The objective of §§ 1500.51, 1500.52, and 1500.53 is to describe specific test methods for simulating normal use of toys and other articles intended for use by children as well as the reasonably foreseeable damage or abuse to which the articles may be subjected. The test methods are for use in exposing potential hazards that would result from the normal use or the reasonably foreseeable damage or abuse of such articles intended for children.
(b) Application—general. (1)(i) The test methods described in §§ 1500.51, 1500.52 and 1500.53 are to be used in determining what is normal use and reasonably foreseeable damage or abuse when specifically referenced under § 1500.18. Other banning regulations may also reference these use and abuse toy test procedures.
(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. As used in this section and in §§ 1500.51, 1500.52, and 1500.53:
(1) Toy means any toy, game, or other article designed, labeled, advertised, or otherwise intended for use by children.
(2) Mouth toy means any toy reasonably intended to be placed into or in contact with a child's mouth.
§ 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. The test methods described in this section shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use by children 18 months of age or less in conjunction with § 1500.18.
(b) Impact test —(1) Application. Except as provided in paragraph (b)(4) of this section, toys having a weight of less than 3.0 pounds ±0.01 pound (1.4 kilograms) shall be subject to this test.
(2) Impact medium. The impact medium shall consist of a 1/8 -inch (0.3-centimeter) nominal thickness of type IV vinyl-composition tile, composition 1—asbestos 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 impact area shall be at least 3 square feet (0.3 square meter). The Commission recognizes that this specified impact medium is the equivalent of, and will yield the same impact test results as, a surface covered with vinyl-asbestos tile meeting the requirements of Federal Specification SS-T-312A.
1 These documents may be ordered from the General Services Administration, Specifications Unit, Room 6654, 7th and D Streets, S.W., Washington, DC 20407. The price of the specification and amendment is $1.00.
(3) Testing procedure. Except as provided in paragraphs (b)(4) (i) and (ii) of this section, the toy shall be dropped 10 times from a height of 4.5 feet ±0.5 inch (1.37 meters) onto the impact medium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop, the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square centimeters), shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. The base area for toys with permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.
(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 —(1) Application. A toy (or component or any accessible portion thereof) that has an external dimension of 1.25 inches ±0.05 inch (3.18 centimeters) or less and a design configuration that would permit a child to insert a portion into the mouth in any orientation up to a biting thickness of 1.25 inches ±0.05 inch (3.18 centimeters), for a penetration of at least 0.25 inch (0.635 centimeter), shall be subject to this test.
(2) Test equipment —(i) Contact mechanism. The contact mechanism shall be two metal strips or plates each measuring 0.25 inch ±0.002 inch (0.635 centimeter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.05 centimeter), for at least a 150-degree cross-sectional arc. A suggested contact mechanism appears in figure 1 of this section.
(ii) Loading device. The loading device shall be a scale or force gauge having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. The test article shall be placed in the contact mechanism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less than 180 degrees of the arc of the contact mechanism, and a test load increasing to 25 pounds ±0.5 pound (11.35 kilograms) shall be evenly applied within 5 seconds. This load shall be maintained for an additional 10 seconds.
(d) Flexure test —(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or other metal material(s), for stiffening or for retention of form if the component can be bent through a 60-degree arc by a maximum force of 10 pounds ±0.5 pound (4.55 kilograms), applied perpendicularly to the major axis of the component at a point 2 inches (5 centimeters) from the intersection of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.
(2) Testing procedure. 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. The component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches ±0.05 inch (5 centimeters) from the intersection of the component with the main body of the toy or applied at the end of the component if the component is less than 2 inches (5 centimeters) long. The component shall then be bent in the reverse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period occurring after each 10 cycles. Two 120-degree arc bends shall constitute one cycle.
(e) Torque test —(1) Application —(i) General. A toy with a projection, part, or assembly that a child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on an accessible rod or shaft designed to rotate along with the projections, parts, or assemblies shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment —(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of ±0.2 inch-pound (±0.23 kilogram-centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of 2 inch-pounds ±0.2 inch-pound (2.30 kilogram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 2 inch-pounds (2.30 kilogram-centimeters) exceeded. The torque or maximum rotation shall be maintained for an additional 10 seconds. The torque shall then be removed and the test component permitted to return to a relaxed condition. This procedure shall then be repeated in a counterclockwise direction.
(f) Tension test —(1) Application —(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test described in paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 10 pounds ±0.5 pound (4.55 kilograms) of force applied in any direction.
(2) Test equipment —(i) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required.
(ii) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. With the test sample fastened in a convenient position, an appropriate clamp shall be attached to the test object or component. A 10-pound ±0.5 pound (4.55-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. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A 10-pound ±0.5 pound (4.55-kilogram) tensile force shall be evenly applied, within a period of 5 seconds, perpendicularly to the major axis of the test component and maintained for an additional 10 seconds.
(g) Compression test —(1) Application. 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.
(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diameter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1/32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. The disc shall be positioned so that the contact surface is parallel to the surface under test. A direct force of 20 pounds ±0.5 pound (9.1 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an additional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.
§ 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. The test methods described in this section, shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use by children over 18 but not over 36 months of age in conjunction with § 1500.18.
(b) Impact test —(1) Application. Except as provided in paragraph (b)(4) of this section, toys having a weight of less than 4.0 pounds ±0.01 pound (1.8 kilograms) shall be subject to this test.
(2) Impact medium. The impact medium shall consist of a 1/8 -inch (0.3-centimeter) nominal thickness of type IV vinyl-composition tile, composition 1—asbestos 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 impact area shall be at least 3 square feet (0.3 square meter). The Commission recognizes that this specified impact medium is the equivalent of, and will yield the same impact test results as, a surface covered with vinyl-asbestos tile meeting the requirements of Federal Specification SS-T-312A.
1 See footnote 1 to § 1500.51.
(3) Testing procedure. Except as provided in paragraph (b)(4) (i) and (ii) of this section, the toy shall be dropped four times from a height of 3 feet ±0.5 inch (0.92 meter) onto the impact medium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop, the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square centimeters) shall be tested for impact in accordance with paragraph (b)(4)(iii) of this section. The base area for toys with permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.
(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 —(1) Application. A toy (or component or any accessible portion thereof) that has an external dimension of 1.25 inches ±0.05 inch (3.18 centimeters) or less and a design configuration that would permit a child to insert a portion into the mouth in any orientation up to a biting thickness of 1.25 inches ±0.05 inches (3.18 centimeters), for a penetration of at least 0.25 inch (0.635 centimeter), shall be subject to this test.
(2) Test equipment —(i) Contact mechanism. The contact mechanism shall be two metal strips or plates each measuring 0.25 inch ±0.002 inch (0.635 centimeter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.05 centimeter) for at least a 150-degree cross-sectional arc. A suggested contact mechanism appears in figure 1 of § 1500.51.
(ii) Loading device. The loading device shall be a scale or force gauge having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. The test article shall be placed in the contact mechanism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less than 180 degrees of the arc of the contact mechanism, and a test load increasing to 50 pounds ±0.5 pound (22.74 kilograms) shall be evenly applied within 5 seconds. This load shall be maintained for an additional 10 seconds.
(d) Flexure test —(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or other metal material(s), for stiffening or for retention of form if the component can be bent through a 60-degree arc by a maximum force of 15 pounds ±0.5 pound (6.80 kilograms) applied perpendicularly to the major axis of the component at a point 2 inches ±0.05 inch (5 centimeters) from the intersection of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.
(2) Testing procedure. 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. The component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches ±0.05 inch (5 centimeters) from the intersection of the component with the main body of the toy or applied at the end of the component if the component is less than 2 inches (5 centimeters) long. The component shall then be bent in the reverse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period occurring after each 10 cycles. Two 120-degree arc bends shall constitute one cycle.
(e) Torque test —(1) Application —(i) General. A toy with a projection, part, or assembly that a child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on an accessible rod or shaft designed to rotate along with the projections, parts, or assemblies shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment —(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of ±0.2 inch-pound (±0.23 kilogram-centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of 3 inch-pounds ±0.2 inch-pound (3.46 kilogram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 3 inch-pounds ±0.2 inch-pound (3.46 kilogram-centimeters) exceeded. The torque or maximum rotation shall be maintained for an additional 10 seconds. The torque shall then be removed and the test component permitted to return to a relaxed condition. This procedure shall then be repeated in a counterclockwise direction.
(f) Tension test —(1) Application —(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test described in paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 15 pounds ±0.5 pound (6.80 kilograms) of force applied in any direction.
(2) Test equipment —(i) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required.
(ii) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of ±0.5 pound (±255 grams).
(3) Testing procedure. With the test sample fastened in a convenient position, an appropriate clamp shall be attached to the test object or component. 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. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A 15-pound ±0.5 pound (6.80-kilogram) tensile force shall be evenly applied, within a period of 5 seconds, perpendicularly to the major axis of the test component and maintained for an additional 10 seconds.
(g) Compression test —(1) Application. 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.
(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diameter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1/32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accurancy of ±0.5 pound (±225 grams).
(3) Testing procedure. The disc shall be positioned so that the contact surface is parallel to the surface under test. A direct force of 25 pounds ±0.5 pound (11.4 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an additional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.
§ 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. The test methods described in this section shall be used to simulate the normal and reasonably foreseeable use, damage, or abuse of toys and other articles intended for use by children over 36 but not over 96 months of age in conjunction with § 1500.18.
(b) Impact test —(1) Application. Except as provided in paragraph (b)(4) of this section, toys having a weight of less than 10.0 pounds ±0.01 pound (4.6 kilograms) shall be subject to this test.
(2) Impact medium. The impact medium shall consist of a 1/8 -inch (0.3-centimeter) nominal thickness of type IV vinyl-composition tile, composition 1—asbestos 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 impact area shall be at least 3 square feet (0.3 square meter). The Commission recognizes that this specified impact medium is the equivalent of, and will yield the same impact test results as, a surface covered with vinyl-asbestos tile meeting the requirements of Federal Specification SS-T-312A.
(3) Testing procedure. except as provided in paragraph (b)(4) (i) and (ii) of this section, the toy shall be dropped four times from a height of 3 feet ±0.5 inch (0.92 meter) onto the impact medium described in paragraph (b)(2) of this section. The toy shall be dropped in random orientation. After each drop, the test sample shall be allowed to come to rest and shall be examined and evaluated before continuing.
(4) Large and bulky toys. (i) A toy that has a projected base area of 400 or more square inches (2,560 or more square centimeters) shall be tested for impact in accordance with paragraph (b)(4)(iii) of this subsection. The base area for toys having permanently attached legs shall be measured by calculating the area enclosed by straight lines connecting the outermost edge of each leg of the perimeter.
(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 —(1) Application. A toy (or component) that is a mouth toy shall be subject to this test.
(2) Test equipment —(i) Contact mechanism. The contact mechanism shall be two metal strips or plates each measuring 0.25 inch ±0.002 inch (0.635 centimeter) high and each having a contact edge radius of 0.020 inch ±0.002 inch (0.5 centimeter) for at least a 150-degree cross-sectional arc. A suggested contact mechanism appears in figure 1 of § 1500.51.
(ii) Loading device. The loading device shall be a scale or force gauge having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. The test article shall be placed in the contact mechanism in any reasonable position for a penetration of 0.25 to 0.5 inch (0.64 to 1.27 centimeters), which position utilizes less than 180 degrees of the arc of the contract mechanism, and a test load increasing to 100 pounds ±0.5 pound (45.50 kilograms) shall be evenly applied within 5 seconds. This load shall be maintained for an additional 10 seconds.
(d) Flexure test —(1) Application. This test shall be applied to each component of a toy containing metal wire(s), or other metal material(s), for stiffening or for retention of form if the component can be bent through a 60-degree arc by a maximum force of 15 pounds ±0.5 pound (6.80 kilograms) applied perpendicularly to the major axis of the component at a point 2 inches ±0.05 inch (5 centimeters) from the intersection of the component with the main body of the toy or at the end of the component if the component is less than 2 inches ±0.05 inch (5 centimeters) long.
(2) Testing procedure. 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. The component shall then be bent through a 60-degree arc by a force applied at a point on the component 2 inches (5 centimeters) from the intersection of the component with the main body of the toy or applied at the end of the component if the component is less than 2 inches (5 centimeters) long. The component shall then be bent in the reverse direction through a 120-degree arc. This process shall be repeated for 30 cycles at a rate of one cycle per two seconds with a 60-second rest period occurring after each 10 cycles. Two 120-degree arc bends shall constitute one cycle.
(e) Torque test —(1) Application —(i) General. A toy with a projection, part, or assembly that a child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test.
(ii) Toys with rotating components. Projections, parts, or assemblies that are rigidly mounted on an accessible rod or shaft designed to rotate along with the projections, parts, or assemblies shall be tested with the rod or shaft clamped to prevent rotation.
(2) Test equipment —(i) Loading device. The loading device shall be a torque gauge, torque wrench, or other appropriate device having an accuracy of ±0.2 inch-pound (±0.23 kilogram-centimeter).
(ii) Clamp. The clamp shall be capable of holding the test component firmly and transmitting a torsional force.
(3) Testing procedure. With the toy rigidly fastened in any reasonable test position, the clamp is fastened to the test object or component. A torque of 4 inch-pounds ±0.2 inch-pound (4.60 kilogram-centimeters) shall be applied evenly within a period of 5 seconds in a clockwise direction until a rotation of 180 degrees from the original position has been attained or 4 inch-pounds ±0.2 inch-pound (4.60 kilogram-centimeters) exceeded. The torque or maximum rotation shall be maintained for an additional 10 seconds. The torque shall then be removed and the test component permitted to return to a relaxed condition. This procedure shall then be repeated in a counterclockwise direction.
(f) Tension test —(1) Application —(i) General. Any projection of a toy that the child can grasp with at least the thumb and forefinger or the teeth shall be subject to this test. This test is to be conducted on the same toy that has been subjected to the torque test described in paragraph (e) of this section.
(ii) Stuffed toys and beanbags. A stuffed toy or beanbag constructed of pliable materials having seams (such as fabrics) shall have the seams subjected to 15 pounds ±0.5 pound (6.80 kilograms) of force applied in any direction.
(2) Test equipment —(i) Clamps. One clamp capable of applying a tension load to the test component is required. A second clamp suitable for applying a tension load perpendicularly to the major axis of the test component is also required.
(ii) Loading device. The loading device is to be a self-indicating gauge or other appropriate means having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. With the test sample fastened in a convenient position, and appropriate clamp shall be attached to the test object or component. 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. The tension clamp shall then be removed and a second clamp appropriate for pulling at 90 degrees shall be attached to the test object or component. A 15-pound ±0.5 pound (6.80-kilogram) tensile force shall be evenly applied, within a period of 5 seconds, perpendicularly to the major axis of the test component and maintained for an additional 10 seconds.
(g) Compression test —(1) Application. 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.
(2) Test apparatus. The loading device shall be a rigid metal disc 1.125 inches ±0.015 inch (2.86 centimeters) in diameter and 0.375 inch (0.95 centimeter) in thickness. The perimeter of the disc shall be rounded to a radius of 1/32 inch (0.08 centimeter) to eliminate irregular edges. The disc shall be attached to an appropriate compression scale having an accuracy of ±0.5 pound (±225 grams).
(3) Testing procedure. The disc shall be positioned so that the contact surface is parallel to the surface under test. A direct force of 30 pounds ±0.5 pound (13.6 kilograms) shall be evenly applied within 5 seconds through the disc. This load shall be maintained for an additional 10 seconds. During the test the toy is to rest on a flat, hard surface in any convenient position.
§ 1500.81   Exemptions for food, drugs, cosmetics, and fuels.
(a) Food, drugs, and cosmetics. Substances subject to the Federal Food, Drug, and Cosmetic Act are exempted by section 2(f)(2) of the act; but where a food, drug, or cosmetic offers a substantial risk of injury or illness from any handling or use that is customary or usual it may be regarded as misbranded under the Federal Food, Drug, and Cosmetic Act because its label fails to reveal material facts with respect to consequences that may result from use of the article (21 U.S.C. 321(n)) when its label fails to bear information to alert the householder to this hazard.
(b) Fuels. A substance intended to be used as a fuel is exempt from the requirements of the act when in containers that are intended to be or are installed as part of the heating, cooling, or refrigeration system of a house. A portable container used for delivery or temporary or additional storage, and containing a substance that is a hazardous substance as defined in section 2(f) of the act, is not exempt from the labeling prescribed in section 2(p) of the act, even though it contains a fuel to be used in the heating, cooking, or refrigeration system of a house.
§ 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 ) under § 1500.3(b)(15(i)), presenting facts in support of his contention. The commission shall determine on the basis of the facts submitted, and all other available information, whether the requested exemption is consistent with the purposes of the act. If the Commission so finds, it shall detail the exemption granted and the reasons therefor by an appropriate order in the 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
(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 times the maximum pressure developed under closed nozzle conditions at 120 °F., whichever is greater.
(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 times the maximum pressure which will be developed in the container at 120 °F.
(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):
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.
(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.
§ 1500.85   Exemptions from classification as banned hazardous substances.
(a) The term banned hazardous substances as used in section 2(q)(1)(A) of the act shall not apply to the following articles provided that these articles bear labeling giving adequate directions and warnings for safe use:
(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 ounces when used as directed.
(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]
§ 1500.86   Exemptions from classification as a banned toy or other banned article for use by children.
(a) The term banned hazardous substance as used in section 2(q)(1)(A) of the act (repeated in § 1500.3(b)(15)(i)(A)) of the act shall not apply to the following articles:
(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 ) (R p ), where m b = mass of a single ball in grams and
R p = pivot length in mm.
(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 -inch) diameter with a flat head) dropped 1220 mm (48 inches) in a vented steel or aluminum tube (60-mm (2 3/8 -inch) inside diameter) when the ball is placed on a steel or cast iron mount. 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 by dropping the impact weight from a height of less than 1220 mm (48 in.), where the height is computed as follows:
Adjusted drop height in mm = 179 × 10 −5 (m b ) (R p 2), where m b = mass of a single ball in grams and
R p = pivot length in mm.
(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 inch) high on the main panel of the container and at least 3 mm ( 1/8 ) high on all accompanying literature.
(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:
(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 ) Be sufficiently wide to allow the dive stick to lie along the bottom with its long axis in a horizontal position,
( 2 ) Have clear side walls to permit observation of the dive stick under water, and
( 3 ) Be placed on a level surface and have a flat bottom.
(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 inch [13 mm] of the dive stick.
(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.
§ 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.
§ 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 on children's electronic devices.
§ 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 cpsc-os@cpsc.gov. and titled “Section 101 Request for Lead Content Determination.” Requests may also be mailed, preferably in five copies, to the Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda, Maryland 20814, or delivered to the same address.
(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 for comment. If the Commission concludes that the request shall be denied, the requestor shall be notified in writing of the denial from the Office of the Secretary along with the official ballot results and the EXHR staff's memorandum of recommendation.
(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. EXHR will review and evaluate any comments and supporting documentation before making its final recommendation to the Commission for final agency action, by staff memorandum submitted to the Commission. If the Commission, after review of the staff's final recommendation, determines that a material or product does not and would not exceed the lead content limits, it will decide by ballot vote, on whether to publish a final rule in the 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.
§ 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. The CPSIA provides the following functional purpose exception from the lead limits stated in section 101(a) of the CPSIA.
(1) Functional purpose exception —(i) In general. 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
(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. For purposes of paragraph (b)(1)(i)(C) of this section, there is no measurable adverse effect on public health or safety if the exception described in paragraph (b)(1)(i) of this section will result in no measurable increase in blood lead levels of a child. The Commission may adopt an alternative method of measurement other than blood lead levels if it determines, after notice and a hearing, that such alternative method is a better scientific method for measuring adverse effect on public health and safety.
(iii) Procedures for granting exception —(A) Burden of proof. A party seeking an exception under paragraph (b)(1)(i) of this section has the burden of demonstrating that it meets the requirements of such paragraph.
(B) Grounds for decision. In the case where a party has petitioned for an exception, in determining whether to grant the exception, the Commission may base its decision solely on the materials presented by the party seeking the exception and any materials received through notice and a hearing.
(C) Admissible evidence. In demonstrating that it meets the requirements of paragraph (b)(1)(i) of this section, a party seeking an exception under such paragraph may rely on any nonproprietary information submitted by any other party seeking such an exception and such information shall be considered part of the record presented by the party that relies on that information.
(D) Scope of exception. If an exception is sought for an entire product, the burden is on the petitioning party to demonstrate that the criteria in paragraph (b)(1)(i) of this section are met with respect to every accessible component or accessible material of the product.
(iv) Limitation on exception. If the Commission grants an exception for a product, class of product, material, or component part under paragraph (b)(1)(i) of this section, the Commission may, as necessary to protect public health or safety:
(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. An exception under paragraph (b)(1)(i) of this section for a product, class of product, material, or component part shall apply regardless of the date of manufacture unless the Commission expressly provides otherwise.
(vi) Previously submitted petitions. A party seeking an exception under this paragraph may rely on materials previously submitted in connection with a petition for exclusion under this section. In such cases, petitioners must notify the Commission of their intent to rely on materials previously submitted. Such reliance does not affect petitioners' obligation to demonstrate that they meet all requirements of this paragraph as required by paragraph (b)(1)(iii)(A) of this section.
(2) [Reserved]
§ 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.
§ 1500.121   Labeling requirements; prominence, placement, and conspicuousness.
(a)(1) Background and scope. Section 2(p)(1) of the Federal Hazardous Substances Act (FHSA) or “the Act”), 15 U.S.C. 1261(p)(1), requires that hazardous substances bear certain cautionary statements on their labels. These statements include: signal words; affirmative statements of the principal hazard(s) associated with a hazardous substance; the common or usual name, or chemical name, of the hazardous substance; the name and place of business of the manufacturer, packer, distributor, or seller; statements of precautionary measures to follow; instructions, when appropriate, for special handling and storage; the statement “Keep Out of the Reach of Children” or its practical equivalent; and, when appropriate, first-aid instructions. Section 2(p)(2) of the Act specifies that all such statements shall be located prominently on the label of such a substance and shall appear in conspicuous and legible type in contrast by typography, layout, or color with other printed matter on the label. This regulation contains the Commission's interpretations and policies for the type size and placement of cautionary material on the labels of hazardous substances and contains other criteria for such cautionary statements that are acceptable to the Commission as satisfying section 2(p)(2) of the Act. Labels that do not comply with this regulation may be considered misbranded.
(2) Definitions. For the purposes of this section:
(i) Container means the immediate package from which a hazardous substance may be dispensed and also any article, package or wrapping, such as a tube or cone used for a firework or a wet cell battery casing containing sulfuric acid, which is necessary for the substance to function during actual use.
(ii) Cautionary material, cautionary labeling, and cautionary labeling required by the Act mean all items of labeling information required by sections 2(p)(1) of the FHSA (repeated in 16 CFR 1500.3(b)(14)(i) or by the regulations which require additional labeling under section 3(b) of the Act.
(iii) Display panel means any surface of the immediate container, and of any outer container or wrapping, which bears labeling.
(iv) Principal display panel means the portion(s) of the surface of the immediate container, and of any outer container or wrapping, which bear(s) the labeling designed to be most prominently displayed, shown, presented, or examined under conditions of retail sale. (See paragraph (c)(1) of this section.)
(v) Type size means the actual height of the printed image of each upper case or capital letter as it appears on the label of a hazardous substance. (See paragraph (c)(2) of this section.)
(vi) Signal word means the appropriate word “DANGER,” “WARNING,” or “CAUTION,” as required by sections 2(p)(1) (C) or (D) of the Act.
(vii) Statement of principal hazard(s) means that wording descriptive of the principal or primary hazard(s) associated with a hazardous substance required by section 2(p)(1)(E) of the Act. Some examples of such statements are “HARMFUL OR FATAL IF SWALLOWED,” “VAPOR HARMFUL,” “FLAMMABLE,” and “SKIN AND EYE IRRITANT.”
(viii) Other cautionary material means all labeling statements, other than “signal words” or “statement(s) of principal hazard(s),” required by the Act or by regulations issued under the Act.
(b) Prominent label placement. 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. Except for the name and place of business of the manufacturer, packer, distributor, or seller, all cautionary material required by the Act shall appear in lines that are generally parallel to any base on which the package rests as it is designed to be displayed for sale or, on display panels other than the principal display panel, in lines generally parallel to all other labeling on that panel. This requirement does not apply to labeling on collapsible tubes, cylindrical containers with a narrow diameter, or F-type containers where both the “front” and “back” of the container are principal display panels. (See paragraph (e) of this section.)
(2) Principal display panel labeling. (i) All items of cautionary labeling required by the Act may appear on the principal display panel on the immediate container and, if appropriate, on any other container or wrapper. See paragraph (b)(4) of this section for requirements and exceptions for labeling outer containers and wrappings.
(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. All items of cautionary labeling required by the Act which do not appear on the principal display panel shall be placed together on a display panel elsewhere on the container. The name and place of business of the manufacturer, packer, distributor, or seller may appear separately on any display panel. Where cautionary material appears on a display panel other than the principal display panel, the principal display panel shall bear the statement “Read carefully other cautions on the ___ panel,” or its practical equivalent. [A description of the location of the other panel is to be inserted in the blank space.]
(4) Outer container or wrappings. All cautionary labeling appearing on the immediate container of a hazardous substance shall also appear on any outer container or wrapping used in the retail display of the substance, in the same manner as required for the immediate container. Those cautionary labeling statements appearing on the immediate container which are clearly legible through any outer container or wrapper used in retail display need not appear on the outer container or wrapping itself. (See section 2(n)(1) of the Act.)
(5) Placement of the word “Poison” and the skull and crossbones symbol. The word “poison” and, when appropriate, the skull and crossbones symbol shall appear on the label of a hazardous substance as follows:
(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. To satisfy the requirement that cautionary labeling statements under the Act be conspicuous and legible, such statements shall conform to the following requirements:
(1) Area of principal display panel. The area of the principal display panel is the area of the side or surface of the immediate container, or of the side or surface of any outer container or wrapping, that bears the labeling designed to be most prominently displayed, shown, presented, or examined under conditions of retail sale. This area is not limited to the portion of the surface covered with labeling; rather, it includes the entire surface. Flanges at the tops and bottoms of cans, conical shoulders of cans, handles, and shoulders and necks of bottles and jars are excluded in measuring the area. For the purposes of determining the proper type size for cautionary labeling, the area of the principal display panel (or other panel bearing cautionary labeling, under paragraph (c)(2)(ii) of this section) is to be computed as follows:
(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. (i) The term type size refers to the height of the actual printed image of each upper case or capital letter as it appears on the label. 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.
(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
> 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. The ratio of the height of a capital or uppercase letter to its width shall be such that the height of the letter is no more than 3 times its width.
(4) Signal word and statements of hazard—capital letters. The signal word, the word “poison” if required instead of a signal word (see § 1500.129), and the statement of principal hazard or hazards shall be in capital letters.
(5) Multiple statement of hazard—type size and style. 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.
(6) Accompanying literature containing directions for use. Where literature accompanying the package of a hazardous substance has directions for use, written or otherwise, section 2(n) of the Act requires the literature to bear cautionary labeling.
(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. To satisfy the requirement that cautionary labeling statements appear in conspicuous and legible type which is in contrast by typography, layout, or color with the other printed matter on the label, such statements shall conform to the following requirements:
(1) Color. Where color is the primary method used to achieve appropriate contrast, the color of any cautionary labeling statement shall be in sharp contrast with the color of the background upon which such a statement appears. Examples of combinations of colors which may not satisfy the requirement for sharp contrast are: black letters on a dark blue or dark green background, dark red letters on a light red background, light red letters on a reflective silver background, and white letters on a light gray or tan background.
(2) Interference with conspicuousness—labeling design, vignettes, or other printed material. For cautionary information appearing on panels other than the principal display panel, the label design, the use of vignettes, or the proximity of other labeling or lettering shall not be such that any cautionary labeling statement is obscured or rendered inconspicuous.
(e) Collapsible metal tubes. Collapsible metal tubes containing hazardous substances shall be labeled so that all cautionary labeling required by the Act appears as close to the dispensing end of the container as possible. The placement and conspicuousness of these statements shall conform to the provisions of paragraphs (b), (c), and (d) of this section.
(f) Unpackaged hazardous substances. Where practicable, unpackaged hazardous substances intended, or distributed in a form suitable, for use in or around a household or by children shall be labeled so that all items of information required by the Act appear upon the article itself. In instances where this is impracticable (for example, because of the size or nature of the article), the required cautionary labeling must be displayed by means of a tag or other suitable material that is no less than five square inches in area and is securely affixed to the article so that the labeling will remain attached throughout conditions of merchandising and distribution to the ultimate consumer. The placement and conspicuousness of all cautionary labeling appearing on such a tag or material, or on an unpackaged article, shall conform to the provisions of paragraphs (b), (c), and (d) of this section. For the purposes of determining the proper type size to use on a tag or other material, the area of one side of the tag or other material shall be the area of the principal display panel.
(g) Exemptions. All requirements of the Act are satisfied by compliance with this § 1500.121. However, exemptions can be granted under section 3(c) of the Act and § 1500.83, or under the provisions of another statute should this section be incorporated in regulations under another statute. Section 1500.82 contains the requirements for exemption requests under the Federal Hazardous Substances Act.
(h) Effective date. The provisions of this rule apply to hazardous substances bearing labels printed after December 30, 1985. Labels printed prior to the effective date of this rule may be applied until not later than December 28, 1987. This rule applies to all hazardous substances to which labels are applied after December 28, 1987.
§ 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, shall specify such reasonable variations or additional label requirements that it finds are necessary for the protection of the public health and safety. Such order shall specify a date that is not less than 90 days after the order is published (unless emergency conditions stated in the order specify an earlier date) after which any such hazardous substance intended, or packaged in a form suitable, for use in the household or by children that fails to bear a label in accordance with such order shall be deemed to be a misbranded hazardous substance.
§ 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.
§ 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 SO 4 ) in a concentration of 10 percent or more.
(c) Nitric acid or any preparation containing free or chemically unneutralized nitric acid (HNO 3 ) in a concentration of 5 percent or more.
(d) Carbolic acid (C 6 H 5 OH), also known as phenol, and any preparation containing carbolic acid in a concentration of 5 percent or more.
(e) Oxalic acid and any preparation containing free or chemically unneutralized oxalic acid (H 2 C 2 O 4 ) in a concentration of 10 percent or more.
(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 H 2 O 2 ) in a concentration of 20 percent or more.
(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 ) in a concentration of 5 percent or more.
(l) Ammonia water and any preparation containing free or chemically uncombined ammonia (NH 3 ), including ammonium hydroxide and “hartshorn,” in a concentration of 5 percent or more.
§ 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:
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.
(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:
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.
§ 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.
§ 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. Substances are toxic by reason of their potential carcinogenicity in humans when they are known or probable human carcinogenic substances as defined below. Substances that are possible human carcinogenic substances or for which there is no evidence of carcinogenic effect under the following categories lack sufficient evidence to be considered toxic by virtue of their potential carcinogenicity.
(1) Known Human carcinogenic Substances (“sufficient evidence” in humans). 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. This category is similar to the Environmental Protection Agency's (EPA) Group A, the International Agency for Research on Cancer's (IARC) Group 1, or the American National Standards Institute's (ANSI) Category 1. A causal relationship is established if one or more epidemiological investigations that meet the following criteria show an association between cancer and exposure to the agent.
(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. Substances are also toxic by reason of their probable carcinogenicity when they meet the “limited evidence” criteria of carcinogenicity in humans or the “sufficient evidence” criteria of carcinogenicity in animals described below. This category is similar to EPA's Group B, IARC's Group 2, or ANSI's Categories 2 and 3. Evidence derived from animal studies that has been shown not to be relevant to humans is not included. For example, such evidence would result when there was an identified mechanism of action for a chemical that causes cancer in animals that has been shown not to apply to the human situation. 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.
(i) “Limited evidence” of carcinogenicity in humans. The evidence is considered limited for establishing a causal relationship between exposure to the agent and cancer when a causal interpretation is credible, but chance, bias, or other confounding factors could not be ruled out with reasonable confidence.
(ii) “Sufficient evidence” of carcinogenicity in animals. Sufficient evidence of carcinogenicity requires that the substance has been tested in well-designed and -conducted studies (e.g., as conducted by National Toxicology Program (NTP), or consistent with the Office of Science Technology Assessment and Policy (OSTP) guidelines) and has been found to elicit a statistically significant (p <0.05) exposure-related increase in the incidence of malignant tumors, combined malignant and benign tumors, or benign tumors if there is an indication of the ability of such benign tumors to progress to malignancy:
(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.
(3) Possible Human Carcinogenic Substance (“limited evidence” animal carcinogen). In the absence of “sufficient” or “limited” human data, agents with “limited” evidence of carcinogenicity from animal studies fall into this category. Such substances, and those that do not fall into any other group, are not considered “toxic.” This does not imply that the substances are or are not carcinogens, only that the evidence is too uncertain to provide for a determination. This category is similar to EPA's Group C, IARC's Group 3, or ANSI's category 4.
(b) Neurotoxicity. Substances are toxic by reason of their potential neurotoxicity in humans when they meet the “sufficient evidence” or “limited evidence” criteria of neurotoxicity in humans, or when they meet the “sufficient evidence” criteria of neurotoxicity in animals.
(1) Known Neurotoxic Substances (“sufficient evidence in humans”). Substances are toxic by reason of their neurotoxicity and are considered “known neurotoxic substances” when they meet the “sufficient evidence” criteria of neurotoxicity derived from studies in humans which require that a causal association between exposure to an agent and neurotoxicity be established with a reasonable degree of certainty. Substances in this category meet the definition of “neurotoxic” as stated above. “Sufficient evidence,” derived from human studies, for a causal association between exposure to a chemical and neurotoxicity is considered to exist if the studies meet the following criteria.
(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. 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. Evidence derived from animal studies that has been shown not to be relevant to humans is not included. Such evidence would result, for example, when there was an identified mechanism of action for a chemical that causes neurotoxicity in animals that has been shown not to apply to the human situation.
(i) “Limited evidence” of neurotoxicity in humans. The evidence derived from human studies is considered limited for neurotoxicity when the evidence is less than convincing, i.e., one of the criteria of “sufficient evidence” of neurotoxicity for establishing a causal association between exposure to the agent and neurotoxicity is not met, leaving some uncertainties in establishing a causal association.
(ii) “Sufficient evidence” of neurotoxicity in animals. Sufficient evidence of neurotoxicity derived from animal studies for a causal association between exposure to a chemical and neurotoxicity requires that:
(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. “Possible neurotoxic substances” are the substances which meet the “limited evidence” criteria of neurotoxicity evidence derived from animal studies in the absence of human data, or in the presence of inadequate human data, or data which do not fall into any other group. Substances in this category are not considered “toxic.”
(c) Developmental and Reproductive Toxicity —(1) Definitions of “Sufficient” and “Limited” Evidence. The following definitions apply to all categories stated below.
(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. Substances are toxic by reason of their potential developmental or reproductive toxicity when they meet the “sufficient evidence” or “limited evidence” criteria of developmental or reproductive toxicity in humans, or when they meet the “sufficient evidence” criteria of developmental or reproductive toxicity in animals. The Food and Drug Administration (FDA) and the European Economic Community (EEC) have developed categories for teratogens but not other developmental toxicants. The teratogen guidelines limit the information only to structural birth defects and do not include other hazards of developmental toxicity such as embryonal death, fetal death, or functional deficiencies which are also important in assessing the overall toxicity of a substance when administered during pregnancy. Recently, EPA has proposed a system for classifying developmental toxicity. The Occupational Safety and Health Administration (OSHA) has not yet developed any classification for developmental toxicity. The commission has established the following categories for determination of developmental toxicity according to the available evidence.
(i) Known Human Developmental Toxicant (“sufficient evidence in humans”). A substance is considered a “known human developmental toxicant” if there is “sufficient” human evidence to establish a causal association between human exposure and the subsequent occurrence of developmental toxicity manifested by death of the conceptus (embryo or fetus), or structural or functional birth defects. This category (Human Developmental Toxicant) is comparable to category 1 of the EEC and categories D and X of FDA, except that these guidelines are limited to teratogens. This category is also comparable to the category “definitive evidence for human developmental toxicity” proposed by EPA.
(ii) Probable Human Developmental Toxicant. A substance is considered a “probable human developmental toxicant” if there is “limited” human evidence or “sufficient” animal evidence to establish a causal association between human exposure and subsequent occurrence of developmental toxicity. This group (Probable Human Developmental Toxicant) is comparable to the category “adequate evidence for human developmental toxicity” proposed by EPA. This category is also comparable to category 2 of the EEC and category A1 of FDA, except that these guidelines are limited to teratogens.
(iii) Possible Human Developmental Toxicant. A substance is considered a “possible human developmental toxicant” if there is “limited” animal evidence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal association between human exposure and subsequent occurrence of developmental toxicity. EEC, FDA, and EPA have not developed a category comparable to this group. The Commission believes that data from well planned animal studies are important to consider even though they may provide only limited evidence of developmental toxicity.
(3) Male Reproductive Toxicants. Male reproductive toxicants can be grouped into the following different categories based on evidence obtained from human or animal studies.
(i) Known Human Male Reproductive Toxicant. A substance is considered a “known human male reproductive toxicant” if there is “sufficient” human evidence to establish a causal association between human exposure and the adverse effects on male reproductive main endpoints which are mating ability, fertility, and prenatal and postnatal development of the conceptus. This category is comparable to the one termed “Known Positive” in the EPA guidelines on male reproductive risk assessment.
(ii) Probable Human Male Reproductive Toxicant. A substance is considered a “probable human male reproductive toxicant” if there is “limited” human evidence or “sufficient” animal evidence to establish a causal association between human exposure and the adverse effects on male reproductive main endpoints. This category is comparable to the one termed “Probable Positive” in the EPA guidelines on male reproductive risk assessment. However, the EPA category is based only on sufficient animal evidence. CPSC believes that limited human evidence is also sufficient for a chemical to be placed in this category.
(iii) Possible Human Male Reproductive Toxicant. A substance is considered a “possible human male reproductive toxicant” if there is limited animal evidence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal association between human exposure and adverse effects on male reproductive main endpoints. This category is comparable to the one termed “Possible Positive A” in the EPA guidelines on male reproductive risk assessment. EPA proposes to use either limited human or limited animal evidence data to classify a toxicant as a “Possible Positive A” toxicant. As described above, CPSC would elevate limited human evidence to the category “Probable Human Male Reproductive Toxicant.”
(4) Female Reproductive Toxicants. Female reproductive toxicants can be grouped into the following different categories based on evidence obtained from human or animal studies. EPA has proposed guidelines for assessing female reproductive risk but has not yet proposed a specific system for categorization of female reproductive toxicants.
(i) Known Human Female Reproductive Toxicant. A substance is considered a “known human female reproductive toxicant” if there is “sufficient” human evidence to establish a causal association between human exposure and adverse effects on female reproductive function such as mating ability, fertility, and prenatal and postnatal development of the conceptus.
(ii) Probable Human Female Reproductive Toxicant. A substance is considered a “probable human female reproductive toxicant” if there is “limited” human evidence or “sufficient” animal evidence to establish a causal association between human exposure and adverse effects on female reproductive function.
(iii) Possible Human Female Reproductive Toxicant. A substance is considered a “possible human female reproductive toxicant” if there is “limited” animal evidence, in the absence of human data, or in the presence of inadequate human data, or which does not fall into any other group, to establish a causal association between human exposure and adverse effects on female reproductive function.
(d) Other Subjects Related to the Determination that a Substance is Toxic. Under the FHSA, for a toxic substance to be considered hazardous, it must not only have the potential to be hazardous but there must also be the potential that persons are exposed to the substance, that the substance can enter the body, and that there is a significant risk of an adverse health effect associated with the customary handling and use of the substance. Under these guidelines, existence of an adverse health effect means that such exposure is above the “acceptable daily intake” (“ADI”). The ADI is based on the risks posed by the substance, and whether they are acceptable under the FHSA. This section addresses those issues by providing guidelines concerning assessment of exposure, assessment of bioavailability, determination of acceptable risks and the ADI to children and adults, and assessment of risk.
(1) Assessment of Exposure. An exposure assessment may comprise a single exposure scenario or a distribution of exposures. Reasonably foreseeable use, as well as accidental exposure, should be taken into consideration when designing exposure studies. The following guidelines should be used in the assessment of exposure.
(i) Inhalation. Inhalation studies to assess exposure should be reliable studies using direct monitoring of populations, predictions of exposure through modeling, or surrogate data.
(A) Direct Monitoring. Populations to be monitored should be selected randomly to be representative of the general population, unless the exposure of a particular subset population is the desired goal of the assessment. The monitoring technique should be appropriate for the health effect of interest.
(B) Modeling. Predictions of exposure to a chemical using mathematical models can be based on physical and chemical principles, such as mass balance principles. Mass balance models should consider the source strength of the product of interest, housing characteristics, and ambient conditions likely to be encountered by the studied population.
(C) Surrogate Data. Surrogate data should only be used when data concerning the chemical of interest are sparse or unavailable and when there is a reasonable assurance that the surrogate data will accurately represent the chemical of interest.
(ii) Oral Ingestion. Oral ingestion studies may involve direct monitoring of sources of chemicals as well as laboratory simulations. The estimation of exposure from ingestion of chemicals present in consumer products is predicted based upon estimates of use of the product and absorption of the chemical from the gastrointestinal tract. The following criteria should be established for laboratory simulations to estimate exposure:
(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. (A) Dermal exposure involves estimating the amount of substance contacting the skin. This may involve experiments measuring the amount of material leached from a product contacting a liquid layer which interfaces with the skin, or the amount of substance which migrates from a product (in solid or liquid form) which is in contact with the skin.
(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. (i) The need to consider bioavailability in estimating the risk from use of a product containing a toxic substance only arises when it is anticipated that the absorption characteristics of a substance to which there is human exposure will differ from those characteristics for the substance tested in the studies used to define the dose-response relationship.
(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. This section on quantitative risk assessment applies to estimates of risk for substances that are toxic by reason of their carcinogenicity.
(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 power should be used. There is the possibility that this factor may be changed, using the 1/4 power instead of the 1/3 power, as part of a unified Federal regulatory approach. If such an approach is adopted, it will apply here.
(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 —(i) ADI for Carcinogens. The maximum acceptable daily intake (“ADI”) is that exposure of a toxic (by virtue of its carcinogenicity) substance that is estimated to lead to a lifetime excess risk of one in a million. Exposure refers to the anticipated exposure from normal lifetime use of the product, including use as a child as well as use as an adult.
(ii) ADI for Neurotoxicological and Developmental/Reproductive Agents. Due to the difficulties in using a numerical risk assessment method to determine risk for neurotoxicological or developmental/reproductive toxicants, the Commission is using a safety factor approach, as explained below.
(A) Human Data. If the hazard is ascertained from human data, a safety factor of ten will be applied to the lowest No Observed Effect Level (“NOEL”) seen among the relevant studies. If no NOEL can be determined, a safety factor of 100 will be applied to the Lowest Observed Effect Level (“LOEL”). Both the NOEL and LOEL are defined in terms of daily dose level.
(B) Animal Data. If the hazard is ascertained from animal data, a safety factor of one hundred will be applied to the lowest NOEL. If no NOEL can be determined, a safety factor of one thousand will be applied to the lowest LOEL. Both the NOEL and LOEL are defined in terms of daily dose level.
§ 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.
(2) General and continuing forms.
(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) The U.S. Consumer Product Safety Commission issues this guidance to manufacturers, importers, distributors, and retailers to protect children from hazardous exposure to lead in consumer products. 1 The Commission identifies the major factors that it considers when evaluating products that contain lead, and informs the public of its experience with products that have exposed children to potentially hazardous amounts of lead.
1 This guidance is not a rule. It is intended to highlight certain obligations under the Federal Hazardous Substances Act. Companies should read that Act and the accompanying regulations in this part for more detailed information.
(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. Young children are most commonly exposed to lead in consumer products from the direct mouthing of objects, or from handling such objects and subsequent hand-to-mouth activity. 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. The adverse health effects of lead poisoning in children are well-documented and may have long-lasting or permanent consequences. These effects include neurological damage, delayed mental and physical development, attention and learning deficiencies, and hearing problems. Because lead accumulates in the body, even exposures to small amounts of lead can contribute to the overall level of lead in the blood and to the subsequent risk of adverse health effects. Therefore, any unnecessary exposure of children to lead should be avoided. The scientific community generally recognizes a level of 10 micrograms of lead per deciliter of blood as a threshold level of concern with respect to lead poisoning. To avoid exceeding that level, young children should not chronically ingest more than 15 micrograms of lead per day from consumer products.
(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261(f)(1), household products that expose children to hazardous quantities of lead under reasonably foreseeable conditions of handling or use are “hazardous substances.” A household product that is not intended for children but which creates such a risk of injury because it contains lead requires precautionary labeling under the Act. 15 U.S.C. 1261(p). A toy or other article intended for use by children which contains a hazardous amount of lead that is accessible for children to ingest is a banned hazardous substance. 15 U.S.C. 1261(q)(1)(B). In evaluating the potential hazard associated with products that contain lead, the Commission staff considers these major factors on a case-by-case basis: the total amount of lead contained in a product, the bioavailability of the lead, the accessibility of the lead to children, the age and foreseeable behavior of the children exposed to the product, the foreseeable duration of the exposure, and the marketing, patterns of use, and life cycle of the product.
(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.
§ 1500.231   Guidance for hazardous liquid chemicals in children's products.
(a) Summary. The U.S. Consumer Product Safety Commission issues this guidance to manufacturers, importers, distributors, and retailers to protect children from exposure to hazardous chemicals found in liquid-filled children's products, such as rolling balls, bubble watches, necklaces, pens, paperweights, keychains, liquid timers, and mazes. 1 The Commission identifies the major factors that it considers when evaluating liquid-filled children's products that contain hazardous chemicals, and informs the public of its experience with exposure to these hazardous chemicals to children. To reduce the risk of exposure to hazardous chemicals, such as mercury, ethylene glycol, diethylene glycol, methanol, methylene chloride, petroleum distillates, toluene, xylene, and related chemicals, the Commission requests manufacturers to eliminate the use of such chemicals in children's products. The Commission also recommends that, before purchasing products for resale, importers, distributors, and retailers obtain assurances from manufacturers that liquid-filled children's products do not contain hazardous liquid chemicals.
1 This guidance is not a rule. It is intended to highlight certain obligations under the Federal Hazardous Substances Act. Companies should read that Act and the accompanying regulations in this part for more detailed information.
(b) Hazard. During reasonably foreseeable handling or use of liquid-filled children's products, hazardous chemicals may become accessible to young children in a manner that places children at risk. Young children are exposed to the chemicals from directly mouthing them or from handling such objects and subsequent hand-to-mouth or hand-to-eye activity. 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. 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. The chemicals may also be combustible.
(c) Guidance. (1) Under the Federal Hazardous Substances Act (FHSA), products that are toxic or irritants and that may cause substantial injury or illness under reasonably foreseeable conditions of handling or use, including reasonably foreseeable ingestion by children, are “hazardous substances.” 15 U.S.C. 1261(f)(1). A product that is not intended for children, but that creates a risk of substantial injury or illness because it contains hazardous chemicals, requires precautionary labeling under the Act. 15 U.S.C. 1261(p). A toy or other article intended for use by children that contains an accessible and harmful amount of a hazardous chemical is banned. 15 U.S.C. 1261(q)(1)(A). In evaluating the potential hazard associated with children's products that contain hazardous chemicals, the Commission's staff considers certain factors on a case-by-case basis, including: the total amount of the hazardous chemical in a product, the accessibility of the hazardous chemicals to children, the risk presented by that accessibility, the age and foreseeable behavior of the children exposed to the product, and the marketing, patterns of use, and life cycle of the product.
(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.