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The Line on Lead Testing

How much testing is too much?

By Susan DeRagon and Alan Schoem -- Gifts and Dec, 4/1/2009 12:00:00 AM

On August 14, 2008, the Consumer Product Safety Improvement Act of 2008 (CPSIA) was signed into law. The CPSIA was, in part, a reaction to the numerous recalls in 2007 and 2008 of children's toys bearing high levels of lead in the paint—despite the mandatory ban on lead-containing paint dating back to 1978. It gives the U.S. Consumer Product Safety Commission (CPSC) significantly increased regulatory and enforcement authority, authorizes increased funding and staff, and imposes new requirements on consumer products regulated by the CPSC, particularly children's products.

Among other things, the CPSIA requires importers and domestic manufacturers of products subject to any rule, ban, standard, or regulation (hereafter "regulations") enforced by the CPSC to certify that their products comply with each applicable regulation. This general conformance certification must be based on a test of each product or a reasonable testing program. There are special requirements for children's products in that the CPSIA establishes a schedule under which children's products must be certified as complying with applicable regulations based on testing by a CPSC-accredited independent laboratory.

The CPSC did issue a stay of enforcement, until February 10, 2010, of testing and certification requirements (including ones that went into effect on November 12, 2008) with specified exceptions. Despite the stay, many companies are continuing to test and certify, and many retailers are requiring their suppliers to do so. In our view, good business practice, especially after the recalls experienced in the past year, mandates product testing despite the CPSC stay, as products must still comply with all applicable regulations, and the consuming public expects it.

Components vs. finished products

Debate continues over whterh a company like Lego can certify its bricks before they
Debate continues over whterh a company like Lego can certify its bricks before they're inserted into building sets.

Under the CPSIA, a new restriction on the total amount of lead in the substrates of children's products took effect on February 10, 2009. This total lead limit is restricted to no more than 600 parts per million (ppm), reduced to no more than 300 ppm on August 14, 2009, and further reduced to no more than 100 ppm on August 14, 2011—if technologically feasible.

There appears to be some confusion about the appropriate testing to be performed—finished product or component testing—to meet the standards. According to the CPSC's most recent guidance, when the requirement for testing by a CPSC-accredited laboratory takes effect, lead-content testing must be performed on finished products. CPSC is evaluating this interpretation and is seeking comment.

Until third party testing is required, companies can certify conformance based on component testing. In some cases, the finished product may be a set comprised of multiple "identical" components such as plastic building bricks. In this case, the bricks used in one set may be identical to the bricks used in other sets, whether that building set consists of 16, 32, or 144 bricks, for example. The testing that takes place is not of the plastic resin as a raw material, but rather of each of the components/bricks in their finished-product state.

Labs going overboard?

If the components of a product have been tested and comply with the total lead requirements, the question has been raised whether components from the same production run must be tested repeatedly when they are incorporated into different sets. It is our view that if a manufacturer has world class traceability procedures and can assure that the components used in the various sets are from the same production run, there is no need to test the identical components in each set.

Some laboratories may be advising their clients that certification can only be based on testing each component of each finished product even if the components in each finished product are identical in that they are from the same production run. We disagree with this approach and believe it is not required nor necessary to assure product compliance.

Further, we believe that the domestic manufacturer or importer could reasonably certify finished products based on component testing and certification. If a component is certified by the component manufacturer as meeting the lead requirements, in our view it would be redundant for the finished product manufacturer to test the already certified components after they are incorporated into the finished product, unless such incorporation could somehow add to the level of lead in the finished product. Testing and certifying components of a finished product could be considered a reasonable testing program under the general conformance certification provisions of the CPSIA.

Manufacturers and importers who certify a finished product based on component testing must understand they are responsible for compliance of the finished product. Procedures must be in place to assure the reliability of their component testing and have world-class traceability procedures so they know which components are incorporated into which finished products.

Once the requirement for testing by a CPSC-accredited laboratory is effective, under current CPSC interpretation, the certification must be based on testing of finished product. But it is still our opinion that the finished product component testing discussed above is acceptable to meet the requirements of the CPSIA and to certify the safety of the finished product. Duplicative testing of identical products should not be required, provided sufficient traceability is evident, and should not be encouraged by testing labs, retailers or the CPSC. It only adds to the cost, but not the safety, of the product. Cross-referencing test results of identical components should be allowed as part of a reasonable testing program, even when third-party testing is required.

A 'reasonable' process

The CPSIA adds significant new requirements for companies manufacturing, importing and distributing children's products. While we support CPSIA's goal of increasing the safety of children's products, there are a lot of details—frequency of testing, adequate sample size, "per shipment" or "per order" testing—that still must be defined by the CPSC. The result should be that third-party testing requirements be based on a reasonable testing program that takes into account finished product component testing.



Author Information
Susan DeRagon is Associate Director of Toys & Premiums at Specialized Technology Resources, an Enfield, Conn.-based provider of quality assurance services and a CPSC-accredited laboratory. She is also a contributing member of the Toy Industry Association's Technical Committee, the ASTM F15.22 subcommittee for toy safety and the International Consumer Product Health and Safety Organization.
Alan Schoem is a senior vice president for New York-based Marsh Risk Consulting's Product Risk Practice. He assists firms with product-related regulatory compliance, establishing procedures for conducting recalls and minimizing the risks and liabilities associated with them. Schoem previously was director of CPSC's Office of Compliance.
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