Wednesday June 06, 2012

Insight: CPSC Proposes New Regulation Allowing Use of XRF for Lead Certification Testing in Substrates of Children’s Products

By Quin Dodd, Esq.

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On May 24, 2012, the CPSC published for public comment a proposed Lab Accreditation Rule, establishing formal requirements for laboratories to be recognized by the agency to conduct testing of children’s products to CPSC mandatory safety standards, like the limits for lead in paints/surface coatings (90 ppm limit) and accessible substrates (100 ppm limit) of such products. This regulation is now under a 75-day public comment period and is expected to go into effect later this year.

A key part of this proposed regulation is a restatement of all previously issued CPSC approved lab test methods for children’s product safety standards, including the traditional method of testing for lead and other heavy metals using inductively coupled plasma (ICP) instruments, or so-called “wet chemistry” testing. In addition, the regulation contains a new test method (ASTM F2853-10) that will allow labs to use “high-definition x-ray fluorescence” (HDXRF) instruments to measure lead in various substrate materials of children’s products, to support certification of those products. Traditional (“handheld”) XRF would also be allowed for lead substrate testing, per the ASTM F2617-08 test method, but under more limited circumstances than HDXRF. These are significant new actions by the CPSC but are not yet well understood.

This new proposal builds upon the CPSC’s decision last year to allow labs to use HDXRF to measure lead in paints/other surface coatings on children’s products and household furniture. Collectively, these new test methods can afford labs, manufacturers, importers and retailers of children’s products an attractive alternative to wet chemistry testing, since both HDXRF and traditional XRF testing are non-destructive of samples and can be conducted quickly and with minimal equipment, staff training and sample preparation. HDXRF and XRF can also be utilized outside of a laboratory environment, for example at a factory, warehouse, or even in an office, and portable versions of these instruments are available for such on-site testing.

In light of these and other advantages of XRF to wet chemistry testing, and considering the January 1, 2012 resumption of the third party testing and certification requirement to the CPSC lead substrate standard, manufacturers and other sellers of children’s products would do well to explore with their lab partners the use of HDXRF/XRF in their lead testing programs and protocols.

What Specifically Has the CPSC Approved Regarding the Use of XRF for Lead Testing in Children’s Products?

1. Lead in Paint. In April 2011, the CPSC approved HDXRF for testing by labs for product certification to the lead paint standard. (See http://www.cpsc.gov/info/toysafety/leadinpaintlab.html). This method, the only XRF based method so recognized by the CPSC, is particularly useful for product samples with small areas of paint and/or thin layers of paint, which in the past often required the destruction of many product samples to obtain enough paint to conduct wet chemistry testing.¹

2. Lead in Substrate.

A. Plastics. To date, the CPSC has approved HDXRF and XRF only for the testing of lead in plastic (“polymeric”) substrates, and only under certain conditions. These conditions generally require that the product sample be uniform (“homogenous”) in composition and with regard to the levels of lead that may exist in various parts of the sample.² Additional requirements and conditions are placed on the use of traditional XRF. If either type of XRF method obtains an average measurement of between 70 and 130 ppm of lead (30% below or above the 100 ppm regulatory limit), then wet chemistry must be used to confirm test results for product certification.

B. Other Substrates. The proposed new Lab Accreditation Rule would expand the allowed use of HDXRF/XRF for lead testing to incorporate other materials as well, including non-electroplated metals, glass/crystal, and unglazed ceramics. As with plastics, a determination of homogeneity and a measurement of lower than 70 ppm would be necessary in order to certify a product to the lead substrate standard. Using traditional XRF for these other substrates also requires detailed and daily calibration of instruments, and the CPSC notes in the new test method that many such instruments may not be suitable for testing to the regulatory lead substrate limit.

What Do These Actions Mean for Toy/Children’s Product Testing?

With the recent renewal of the CPSC third party testing and certification requirement for the CPSC lead substrate standard, increased CPSC surveillance at US ports of entry, and record civil penalties being imposed for violations of CPSC laws, many importers and other companies are increasingly looking for ways to minimize testing costs while ensuring compliance with standards. Third party lead paint and substrate testing using HDXRF/XRF technology is one way these companies are finding both cost and time savings. This most recent proposal by the CPSC could enhance such efforts significantly, particularly if the CPSC takes a more pragmatic approach to the issue of homogeneity of samples in the final version of the Lab Accreditation Rule.

In addition, HDXRF/XRF has been a key component of manufacturers’ and others’ first party (in-house) testing programs. Many firms now screen children’s products using HDXRF/XRF, both before and after required third party testing, to further assure compliance with standards and to identify where “problem areas” may exist in their product lines. Relatedly, the “Mother of all CPSC Regulations,” the Testing and Certification Rule, will take effect just nine months from now, in February 2013. Among other things, this detailed new regulation provides for “production testing” for children’s products (first party testing as the product is being made). CPSC recognized XRF technologies are well-suited to conduct such in-house screening and production testing. The proposed new CPSC Lab Accreditation Rule should serve to validate and encourage the expansion of HDXRF/XRF testing generally, giving industry, regulators and consumers greater peace of mind that children’s products are in compliance with the tough CPSC lead standards.

Quin Dodd is an attorney practicing exclusively in the area of federal, state and international product safety law, representing a variety of companies in the field (including XOS, Inc., a manufacturer of high-definition x-ray flouresence [“HDXRF”] heavy metals analyzers). Quin served from 2005 – 2008 as Counsel and then Chief of Staff to Commissioner and former Acting Chairman of the CPSC, Nancy A. Nord. For more information: quin@quindoddlaw.com.

1 While the CPSC Component Part Testing Rule does allow for the testing of “wet” paint by itself, the detailed documentation and “due care” requirements that the rule imposes may not make it available or attractive in many instances, leaving HDXRF as the only practical alternative to sample destruction of toys and other children’s products.

2 Note that there is no such requirement for prequalification of samples for homogeneity when testing using wet chemistry. CPSC staff have thus far offered no justification for imposing this requirement on XRF test methods.