Testing Compliance
March 1, 2009
What
steps do manufacturers need to take in order to demonstrate CPSIA compliance?
The Consumer Product Safety Improvement Act (CPSIA), which was signed into law August 14, 2008, encompasses a number of new rules for the safe manufacture of children’s products. (Editor’s note: To learn more about the specific requirements of the CPSIA, see “Understanding the CPSIA”.)
A major requirement of the new legislation is that manufacturers and private labelers must submit samples of certain products for lead testing by an independent laboratory before the products can be imported, warehoused, or sold in the U.S. However, because the requirements will be phased in over the next several months, some suppliers have expressed confusion about what is required and when it will be required. In particular, many companies feel that in-house testing may be sufficient to demonstrate compliance when, in fact, testing by an accredited laboratory is required.
Although the CPSIA specifically requires third-party testing, it does allow for in-house testing provided that:
In the U.S., the major accrediting body for the CPSIA is ACLASS Accreditation Services. This organization is the ANSI-ASQ National Accreditation Board that provides laboratory accreditation for testing and calibration laboratories. The accreditation should cover testing for lead by X-ray fluorescence (XRF), inductively coupled plasma mass spectroscopy (ICP-MS) and inductively coupled plasma optical emission spectroscopy (ICP-OES) in accordance with 16 CFR part 1303, CPSA HR 4040, ASTM F 963-07, and EN 71-3:1995.
The accrediting body performs an audit of the testing facility to clearly demonstrate that the lab has control over its internal systems. The audit includes an examination of test methods and document control (proof that methods are being followed) and an understanding of the scope of each test method (uncertainty and limits). In addition, training documentation is checked to ensure the quality of the personnel running the tests. The aim is to certify that the lab follows a good quality system.
For more information regarding CPSIA testing compliance, contact NSL Analytical Services, 4450 Cranwood Parkway, Cleveland, OH 44128; (216) 438-5200; fax (216) 438-5050; e-mail nsl@nslanalytical.com; or visit the website at www.nslanalytical.com.
The fluorescent radiation can be analyzed either by sorting the photon energies emitted (energy-dispersive analysis) or by separating the radiation wavelengths (wavelength-dispersive analysis). Once sorted, the intensity of each characteristic radiation is directly related to the amount of each element in the material. CPSC recognizes the XRF as a reliable screening test to detect the presence of lead, and XRF testing is sufficient if the detected lead content is no greater than 10 mg or the object being testing has no more than 1 sq cm of surface area.
If the XRF indicates higher levels of lead, ICP or ICP-MS instruments are employed to determine the exact lead level. ICP instrumentation introduces an aqueous solution into an extremely hot plasma gas. Light emitted by the atoms of an element consumed in the plasma is resolved into its component radiation, and the intensity is measured with a photomultiplier tube or solid state detector. The intensity of the electron signal is compared to previously measured standards of known element concentration, and a concentration is computed.
ICP-MS is a highly sensitive type of mass spectrometry that can determine element concentrations below one part per trillion. It is based on coupling an ICP instrument (to produce ions) with a mass spectrometer (to separate and detect the ions). As in ICP analysis, a photomultiplier tube or chip detector measures the light intensity to determine the presence or absence of specific elements.
The Consumer Product Safety Improvement Act (CPSIA), which was signed into law August 14, 2008, encompasses a number of new rules for the safe manufacture of children’s products. (Editor’s note: To learn more about the specific requirements of the CPSIA, see “Understanding the CPSIA”.)
A major requirement of the new legislation is that manufacturers and private labelers must submit samples of certain products for lead testing by an independent laboratory before the products can be imported, warehoused, or sold in the U.S. However, because the requirements will be phased in over the next several months, some suppliers have expressed confusion about what is required and when it will be required. In particular, many companies feel that in-house testing may be sufficient to demonstrate compliance when, in fact, testing by an accredited laboratory is required.
Independent Testing
Third-party testing and certification is a unique provision of the CPSIA, which requires such testing for any children’s product manufactured after December 22, 2008. Section 102 of the CPSIA sets forth testing and certification requirements, and specific details will be announced on the Consumer Product Safety Commission (CPSC) website at www.cpsc.gov/about/cpsia/cpsia.html. This section of the act also requires that all children’s products be accompanied by a certificate of compliance, based on testing, that specifies the applicable rule, ban, standard, and regulation being followed. Certificates must be furnished to each distributor or retailer of the products.Although the CPSIA specifically requires third-party testing, it does allow for in-house testing provided that:
- Testing provides equal or greater consumer safety protection as third-party testing
- Test results are protected from undue influence
- The CPSC is notified of any attempts at (or allegations of)undue influence
What's an Accredited Lab?
Labs performing third-party tests that conform to the CPSIA must be accredited to ISO/IEC 17025, and the accreditation must come from an ILAC-MRA signatory accrediting body. Also, the scope of the accreditation must expressly include testing to the regulations of 16 CFR 1303, which covers lead tests, particularly testing for lead in children’s products. Accredited labs are listed on the CPSC website as “accredited third party test labs able to assess conformity with children’s product safety rules.”In the U.S., the major accrediting body for the CPSIA is ACLASS Accreditation Services. This organization is the ANSI-ASQ National Accreditation Board that provides laboratory accreditation for testing and calibration laboratories. The accreditation should cover testing for lead by X-ray fluorescence (XRF), inductively coupled plasma mass spectroscopy (ICP-MS) and inductively coupled plasma optical emission spectroscopy (ICP-OES) in accordance with 16 CFR part 1303, CPSA HR 4040, ASTM F 963-07, and EN 71-3:1995.
The accrediting body performs an audit of the testing facility to clearly demonstrate that the lab has control over its internal systems. The audit includes an examination of test methods and document control (proof that methods are being followed) and an understanding of the scope of each test method (uncertainty and limits). In addition, training documentation is checked to ensure the quality of the personnel running the tests. The aim is to certify that the lab follows a good quality system.
For more information regarding CPSIA testing compliance, contact NSL Analytical Services, 4450 Cranwood Parkway, Cleveland, OH 44128; (216) 438-5200; fax (216) 438-5050; e-mail nsl@nslanalytical.com; or visit the website at www.nslanalytical.com.
SIDEBAR: Testing for Lead
The typical approach to lead testing is to first scan the object with an XRF gun. XRF instrumentation determines elemental concentration by analyzing the emission of characteristic secondary (or fluorescent) X-rays from a material that has been excited by bombarding it with high-energy X-rays or gamma rays.The fluorescent radiation can be analyzed either by sorting the photon energies emitted (energy-dispersive analysis) or by separating the radiation wavelengths (wavelength-dispersive analysis). Once sorted, the intensity of each characteristic radiation is directly related to the amount of each element in the material. CPSC recognizes the XRF as a reliable screening test to detect the presence of lead, and XRF testing is sufficient if the detected lead content is no greater than 10 mg or the object being testing has no more than 1 sq cm of surface area.
If the XRF indicates higher levels of lead, ICP or ICP-MS instruments are employed to determine the exact lead level. ICP instrumentation introduces an aqueous solution into an extremely hot plasma gas. Light emitted by the atoms of an element consumed in the plasma is resolved into its component radiation, and the intensity is measured with a photomultiplier tube or solid state detector. The intensity of the electron signal is compared to previously measured standards of known element concentration, and a concentration is computed.
ICP-MS is a highly sensitive type of mass spectrometry that can determine element concentrations below one part per trillion. It is based on coupling an ICP instrument (to produce ions) with a mass spectrometer (to separate and detect the ions). As in ICP analysis, a photomultiplier tube or chip detector measures the light intensity to determine the presence or absence of specific elements.