August 11, 2010

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By Sean Oberle

What happens if complying with a regulation is possible but reliably testing for such compliance isn’t? That potentially could be a dilemma facing CPSC in its mandate to see if meeting a 100 parts per million (ppm) lead limit is technologically feasible. Two developments coincided last month that might point to such a problem.

In the July 27 Federal Register, CPSC published a request for feedback on the 100 ppm issue. As our premium sister service Product Safety Letter wrote a week earlier:

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For items already under 100 ppm, CPSC will seek:

• Information and data about tests and materials.
• “Industrial strategies or devices” enabling the limit.
• Information and data on functional or safety affects.

For items not under 100 ppm, CPSC will seek:

• Information and data about tests and materials.
• Information and data on whether different materials could have achieved the limit.
• Information and data on alternate strategies, practices or operations that could have achieved the limit.
• Information and data about the lowest achievable lead limit under 300 ppm.
• When products might be expected to meet the limit.

Meanwhile, in the same edition, PSL had exclusive coverage of a meeting between CPSC staff and YKK’s Jim Reed over numerous CPSIA issues, including a test of testing labs that his company conducted. About that test, PSL wrote:

Reed told the CPSCers that his company sent samples that it knew contained about 71 parts-per-million (ppm) lead to 20 testing labs. Only about half came back with what YKK deemed to be acceptable results: ±10 or 61-81 ppm. The range was 0 ppm to 331 ppm. YKK did not reveal to the labs that it was testing them but rather sent samples as if it simply were seeking results normally.

Reed confirmed that the labs were listed under CPSC’s accreditation program and that they were “big ones that you know the names of.” He also confirmed the labs used ICP methods, referring to those involving inductively coupled plasma techniques. On the other hand, he did not know if YKK has confronted the labs with the results and was cool on the idea of sharing the data with CPSC, explaining that YKK’s concern is not with particular labs “but with the idea that third-party testing buys an additional degree of assurance.”

What might at first seem like an indictment of labs’ quality might actually be a sign of trouble related to overseeing a 100-ppm limit. It’s possible that the same labs might have done perfectly well at 300 ppm.

In a real-world regulatory situation, what might YKK’s experience mean? If a company meets a requirement, is it fair that it has only a 50/50 chance of passing? Conversely, if another company fails the same requirement, is it fair (or safe) that it has as much as a 50/50 chance of passing?

Yes, the YKK situation is anecdotal. There might have been other factors at work in this particular case. Nonetheless, the situation raises some interesting questions for the agency, and at a critical time.


Sean Oberle is publisher of Product Safety Letter, Product Safety Forum, and Product Safety Daily. Reach him at (301) 229-1027, seanoberle@productsafetyletter.com