Children's Products: A Discussion of the Regulations Governing Lead Content
Lead poisoning in children has been found to cause adverse health effects ranging from hyperactivity to developmental delays, blindness and even death. See 16 C.F.R. § 1303.5. Even minimally elevated blood lead levels in children have been linked to lower cognitive functioning, slower growth rates, and cavities in teeth1. The danger of lead exposure is not an acute hazard, with immediately visible injury. Rather the harm results from the cumulative effect of chronic exposure. While a child's exposure to lead could come from a variety of sources, the Federal government has imposed regulations on lead content in paint and children's products aimed at reducing these risks.
Use of lead in products is governed under both the Consumer Products Safety Improvement Act ("CPSIA") of 2008 and the Federal Hazardous Substances Act ("FHSA"). The CPSIA limits the lead content in any children's product2 manufactured after August 14, 2011 to 100 parts per million (ppm)3 unless the Consumer Product Safety Commission (the "CPSC") determines that 100 ppm is not technologically feasible. See 15 U.S.C. § 1278a. Children's products containing lead concentrations higher than 100 ppm are "banned hazardous substances" under the FHSA. It is unlawful to distribute any banned hazardous substance in the United States, and violations can carry both civil and criminal penalties. See 15 U.S.C. § 1263 and 15 U.S.C. § 1264.
"Lead Containing Paint"
The FHSA defines "lead-containing paint" as any paint and other surface coating4 for consumer use that contains lead or lead compounds in which the lead content is in excess of .009%5 of the weight of the total nonvolatile content or the weight of dried paint. See 16 C.F.R. 1303.1. Lead-containing paint, including any toy or article designed or intended for use by children that contains lead-containing paint, is also a "banned hazardous substance" under the FHSA.
The CPSIA allows the CPSC to grant exceptions to the 100 ppm limit for certain products if it determines that the lead content would not present a risk to public health and safety. Manufacturers and importers of children's products should consult 16 C.F.R. § 1500.87 to § 1500.90 for detailed explanations of the exceptions and associated criteria for each. Some exceptions include:
1.The Functional Purpose exception: A manufacturer or importer may seek a specific exception if compliance with the 100 ppm limit is not practicable and the technology is not feasible, but the product is not likely to be placed in a child's mouth or ingested through foreseeable use and abuse by a child6, and granting an exception will have no measurable effect on public health or safety7. It is important to keep in mind that this exception applies only to the 100 ppm threshold, and that the CPSC may set an alternative lead content limit for the product. For example, bicycle manufacturers previously sought an exception under this provision. The CPSC issued a stay on enforcement of the current lead limits with respect to metal components of bicycles and jogging strollers, but set a maximum lead content limit of 300 ppm. See 74 FR 31254. This same exception applies to ride-on pedal cars. See 77 FR 20614.
2. The Inaccessible Component Part exception: If the lead content is contained only in component parts of the product that are not accessible through foreseeable use and abuse by a child, the component part is exempt from the lead limit. In order to qualify under this exception, the lead-containing component part must be sealed in a covering or casing. Paint, coating or electroplating are not considered a covering for the purpose of this exception. Further, to be eligible for this exception, the product must be more than 5 centimeters in one demission.
3. The Electronic Device exception: Electronic devices are exempt from the standard if the components of the product containing lead are equipped with a child-resistant cover or casing. For example, this exception applies to devices containing lead batteries that are under a child-resistant cover, or devices containing a "battery pack" that is inaccessible when the product is fully assembled. This exception also extends to electronic devices where lead is blended into glass of cathode ray tubes.
4. The Off-Highway Vehicles exception: Motorized all-terrain vehicles such as four-wheelers or snow mobiles, designed for use by children under the age of 12, are exempt from the lead standard.
5. The Used Children's Products exception: Used children's products intended for resale are also exempt from this standard, unless the donating or reselling party knows the products are in violation of the applicable lead limit. Usually, children's metal jewelry is not covered by this exception, and therefore must comply with the lead paint rule. The CPSC may also place additional limitations on this exception.
Determining Lead Content
The CPSIA requires that a product manufacturer or importer submit samples of its product to a third-party lab for testing to ensure compliance with the lead standards. See 15 U.S.C. § 2063. Based on the lab's findings, the manufacturer must certify compliance with the standards. A manufacturer should consult 16 C.F.R. §§ 1107, 1109 and 1110 for the testing and certification requirements. In addition, the CPSC's website provides a list of approved laboratories.
The Commission has established a list of classes of products that, by their nature and if not treated or adulterated, would not contain lead and are exempt from the third-party testing requirements. For example, natural and synthetic textiles such as cotton or wool, gemstones, and animal-derived materials such as leather are exempt from mandatory third-party testing. In addition, "ordinary books" are exempt from the third-party testing requirement. 15 U.S.C. § 2063(d)(5). See 16 C.F.R. § 1500.91 for a complete list of products that are exempt from third-party testing.
A manufacturer may petition the CPSC for a determination that a product or component material does not contain lead and, therefore, should be added to the list of items exempt from the third-party testing requirements. See 16 C.F.R. § 1500.89 for the procedure and associated requirements for such a determination. A manufacturer or distributor should be mindful, however, that if production of a final product includes any process that could introduce lead into an exempt material, the finished product no longer qualifies for the exemption.
The risk to children from chronic exposure to lead can be severe. Potential sources of lead in children's products are strictly regulated. Repercussions for failure of a manufacturer, distributor or importer of a children's product to comply with the lead standard could result not only in civil penalties and potential civil litigation, but also in potential criminal penalties under the FHSA.
Manufacturers should use caution to ensure that lead is not introduced into children's products through the manufacturing process or other unexpected sources. For example, using a lead-based alloy to join sections of metal in the manufacture of a product is a potential source of lead content in the finished product that is not found in the component pieces. In addition, use of recycled material in production could introduce unintended lead content. Also, screen-prints on clothing or fasteners such as snaps, buttons or zippers could contain lead that exceed the limits set under the CPSIA. If a product is found to exceed the applicable lead limits as a result of a defect in the manufacturing process, a manufacturer must ensure compliance with all applicable hazardous material disposal requirements during the recall process.
For additional questions, please contact Joy Syrcle, or the Stinson Leonard Street attorney with whom you regularly work.
1 See Preventing Lead Poisoning in Young Children, Center for Disease Control and Prevention, August 2005, available at: http://www.cdc.gov/nceh/lead/publications/prevleadpoisoning.pdf
2 A "children's product" is a product designed for use by children under the age of 12. For a discussion of what is considered a children's product under the CPSIA, see Steuterman, What is a Children's Product available at Resources/Insights/2016_Insights/What_is_a_Children_s_Product_.aspx
3 When passed, the CPSIA set a decreasing limit, allowing lead concentrations of 600 ppm for products manufactured between February 2009 and August 14, 2009, and 300 ppm between August 14, 2009 and August 14, 2011.
4 For the purpose of this regulation, "paint" does not include printing ink or materials that are part of a substrate in another material such as pigment in plastic.
5 This threshold was reduced from .06 percent to .009 percent effective August 14, 2009.
6 The tests for foreseeable use and abuse are set out by age group in 16 C.F.R. § 1500.50 to § 1500.53.
7 Effect on public health or safety here is measured in terms of blood lead levels in children.