CPSC Issues Two Final Rules on Lead and Results of XRF Study
The US Consumer Product Safety Commission (CPSC) recently adopted two final rules that clarify the testing and certification requirements specified in the Consumer Product Safety Improvement Act of 2008 (CPSIA) for certain products, materials, and component parts. CPSC staff also issued the results of its evaluation on the use of X-ray fluorescence spectrometry for analyzing lead in children’s products. A discussion of the final rules and the staff report appears below.
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CPSC Final Rule on Materials that are Exempt from Lead Testing
Background
Section 102(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) requires products intended primarily for children 12 years of age or younger to be tested and certified that they contain less than 300 parts per million (ppm) of lead as of August 14, 2009, and 100 ppm of lead beginning August 14, 2011 (unless determined to be technologically infeasible). In accordance with its authority under section 3 of the CPSIA, the Commission issued a Final Rule on August 19, 2009 establishing that certain materials or products inherently do not contain lead or contain lead at levels that do not exceed these lead content limits.
Materials and Products that Do Not Contain Lead in Excess of the Statutory Limits
The Commission has determined that the materials listed below do not exceed the lead content limits, provided they have not been treated or adulterated by the addition of chemicals and other materials, such as paints, that could result in the addition of lead into the product or material. As a result of the Commission’s determination, the following materials are relieved from the testing and certification requirements specified under section 102 of the CPSIA:
1. The following 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. Examples of minerals that are based on lead or lead compounds and, therefore, are subject to the lead limits include 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 C.F.R. Part 1303, and inks used in after-treatment applications, including screen prints, transfers, decals, or other prints).
7. Textiles (excluding after-treatment applications, including screen prints, transfers, decals, or other prints) consisting of:
a. Dyed or undyed natural fibers 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, giviut, and guanaco;
b. Dyed or undyed manufactured fibers including, but not limited to, rayon, azlon, lyocell, acetate, triacetate, rubber, polyester, olefin, nylon, acrylic, modacrylic, aramid, and 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, and leather.
9. The following metals and alloys, provided that no lead or lead-containing metal is intentionally added:
a. Surgical steel and other stainless steel within the designations of Unified Numbering System, UNS S13800 – S66286, except for stainless steel designated as 303Pb (UNS S30360).
b. The following precious metals: gold (at least 10 karat), sterling silver (at least 925/1000), platinum, palladium, rhodium, osmium, iridium, ruthenium, and titanium.
This 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.
Changes that Would Cause the Product or Material to Exceed the Lead Content Limits
Even though the materials and products listed above are relieved from the testing and certification requirements, manufacturers and importers are responsible for verifying that the material or product has not been altered or modified, or experienced any change in the processing, facility, or supplier conditions that could impart lead into the material or product and to ensure that it meets the CPSIA’s lead limits at all times. According to the Final Rule, the Commission will test products in the marketplace to assure that they comply with the limits and will take appropriate enforcement action if it discovers a violative product.
Component Part Testing
Questions remain regarding component part testing and certification for lead content for children’s products made with several materials and component parts. Component parts are not required to be tested if they (i) are inaccessible, as set forth under 16 C.F.R. § 1500.87; (ii) are or contain an electronic device exempt under the Commission’s regulation at 16 C.F.R. § 1500.88; or (iii) are made of material determined by the Commission to fall under the lead content limits in this rule. All other component parts, however, must be tested and certified under section 102 of the CPSIA at this time. The Commission intends to initiate a rulemaking in the near future to address component part testing, including children’s products that fall within an exemption.
Future Lead Determinations for Other Materials and Products
The Commission encourages stakeholders to continue to identify and provide to the Agency data demonstrating that additional materials do not exceed the CPSIA’s lead limits.
Related Document:
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CPSC Final Rule on Inaccessible Component Parts
Background
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 children. 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, including swallowing, mouthing, breaking, and aging, of the product. Paint, coatings and electroplating are not considered barriers to accessibility.
Final Rule
According to the Final Rule issued on August 7, 2009, an inaccessible component part generally is one that is located inside a children’s product and is not capable of being touched or mouthed by a child, regardless of the part’s visibility. An accessibility probe, of a design specified by CPSC, is used to determine accessibility in a testing laboratory setting. A lead-containing component part is considered inaccessible if it cannot be contacted by a specified segment of the probe, or if it is completely enclosed in a sealed covering or casing and does not become physically exposed through reasonably foreseeable use, abuse, or aging of the product. CPSC has established specific use and abuse tests for children in several age groups: 18 months or younger; over 18 and under 36 months; over 36 and under 96 months; and over 96 months through 12 years.
A fabric-covered component part, such as a fabric-covered button, is considered inaccessible if it is completely enclosed, encased or covered by fabric, if it does not become exposed through foreseeable use or abuse, and if the part or the entire product is no smaller than 5 cm in any one dimension. The Commission does not consider intentional disassembly or destruction of products by children over 8 years using tools and/or knowledge not generally available to younger children to represent foreseeable use and abuse.
A component part of a product deemed to be inaccessible is not subject to the lead limits in the CPSIA. As a result, the component part does not have to be tested and certified to demonstrate compliance with the lead restrictions. Any accessible component of the product, including the sealed covering or casing of an inaccessible component, will require testing and certification unless specifically excluded from lead content or testing requirements.
Related Document:
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CPSC Staff Report on Use of X-ray Fluorescence Spectrometry for Lead Analysis
Background
Section 101(f)(4)(A) of the CPSIA requires the Commission to complete a study evaluating the effectiveness, precision, and reliability of X-ray fluorescence (XRF) technology and other methods for measuring lead in paint or other surface coatings when used on a children’s product to determine compliance with the lead limits established by this legislation.
Staff Evaluation
According to a staff report issued on August 15, 2009, although XRF has the advantages of speed, non-destructiveness and portability for in situ testing, its use in analysis of paint and other surface coatings currently has a number of serious limitations. These include interference from any lead present in an underlying substrate, thickness-dependent results from paint samples with the same lead concentration, lack of a standard analytical method and standard reference materials, and results reported in the wrong units (weight/area, not weight/weight such as % or ppm). Unit conversion to weight/weight requires measurement of both film thickness and density, which is very difficult, especially since film thicknesses may vary significantly across the same toy. Until analytical methods and reference standards have been developed and validated, use of in situ XRF for paint analysis will likely be unacceptable except possibly as a screening tool.
On the other hand, use of XRF for determining lead concentration in homogeneous plastic is currently possible. Standard reference materials and standard test methods are available. Nevertheless, the staff has concluded that XRF results above 200 ppm will have to be confirmed by traditional wet chemistry procedures in order to certify that a product or component meets the lead limits of the CPSIA.
Related Document:
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Please contact any of the individuals below if you have questions regarding the final rules or the staff XRF report.
Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939
James R. Ravitz
ravitz.james@arentfox.com
202.857.8903
Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984
Robert G. Edwards, PhD
edwards.robert@arentfox.com
202.857.6346
Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338