In an advisory issued by the law firm of Arnold & Porter LLP, they highlight the new testing and certification rules coming into effect February 8, 2013 for manufacturers and importers of children’s products. The two rules; 16 C.F.R. Part 1109 (effective December 2011), which permits certification of the product by relying on component part testing or another party’s finished product testing and 16 C.F.R. Part 1107, which outlines the additional requirements concerning certification and ongoing testing and labeling of children’s products. They summarized the key provisions of these regulations which have been discussed previously in this blog.
- Third Party Testing for Certification (§1107.20) – the initial certification must be based on a “sufficient number of samples” that are “identical in all material respects” to a third party laboratory that is accredited by the CPSC to do the testing for initial product certification. If any of the samples submitted fails certification testing then the failure must be investigated by the manufacturer/importer of record and corrective action must be taken and documented before additional samples are re-submitted for testing and certification.
- Periodic Testing (§1107.21) – after the initial certification of the product, periodic testing of the product must continue as long as it is in production. The test plan selected by the manufacturer/importer of record can either be; periodic testing plan (at least once per year), production testing plan (at least once every two years) or ISO 17025 testing plan (at least once every three years). The type of testing plan chosen will depend on several factors and must be done for each manufacturing site.
- Material Change (§1107.23) – any change in a children’s product after initial certification and before the test plan testing time, that would affect the products ability to continue to be compliant, must be re-tested. A material change is defined as; change in manufacturing process or facility, change in souring of component parts or suppliers.
- Undue Influence Policy (§1107.24) – every manufacturer/importer of record must establish a undue influence policy with regard to third party laboratories which should include; a written policy statement from company officials, training for all appropriate employees, attestation of training, means of immediately notifying the CPSC of any attempts of undue influence or attempts to hide undue influence and retraining of employees if undue influence requirements should change.
- Recordkeeping (§1107.26) – records on all children’s products must be maintained by the manufacturer/importer of record for a period of five (5) years and must be made available to the CPSC upon request. These records should include; children’s product certificate per product per manufacturing site, periodic testing records (including the test plan and test results within those test plans), representative samples chosen and the methodology for the representative samples, documentation of all material changes by product by manufacturing site and undue influence training and materials.
- Labeling of Consumer Products to Indicate Compliance (§1107.30) – once a children’s product has met all the applicable rules, bans and standards that would apply to the product, the manufacturer/importer of record can label their product with “Meets CPSC Safety Requirements”
- Reliance on Component Part Testing or Another Party’s Testing or Certification (§1109.5) – a manufacturer/importer of record can rely (with conditions) on testing and certification supplied by a component part supplier or a finished product supplier (manufacturer) for the purposes of final product certification. The CPSC expects the manufacturer/importer of record to exercise “due care” when accepting this testing or certification. Due care (as pointed out in the alert) could include; conducting a reasonable review of the other party’s certification or test reports and addressing any discrepancies or other concern over the validity, confirming that the testing labs have been accredited by the CPSC, asking other third party labs to confirm the authenticity of the test reports, inspecting or auditing factories to ensure that good manufacturing practices have been carried out, proper sampling procedures and the periodic test plan are being followed and that the necessary records are being kept, or submitting samples to another third party lab to verify compliance of the product. The alert goes on to point out that certain documentation must be received from the component supplier or finished product supplier (manufacturer) before the manufacturer/importer of record can rely on these test reports or certifications. They include;
- Identification of a lot or batch number to identify the component part or finished product that the testing or certification applies to
- Identification of the testing methods and sampling protocols used
- Attestation by the third party lab that performed the testing
- Records to support the traceability
- Attestation by component supplier or finished product supplier (manufacturer) and third party lab that while the component part or finished product was in their care, custody and control they exercised due care to ensure compliance with test integrity requirements.
The challenges pointed out in the alert to comply with all the above regulations as it pertains to component part or finished product certification and testing really comes down to; does a manufacturer/importer of record have enough control over the manufacturing process comply with the record keeping of these two rules? There are really only two paths that an importer or finished product manufacturer can take for compliance; either do all the testing on the product themselves or rely on the foreign manufacturer (or component part supplier) testing and certification of the product.
Questions to Ask?
- Can I obtain all of the documentation and develop/implement all the necessary procedures to show that we have exercised “due care” when relying on other parties testing and certification?
- What steps do we need to take to “reasonably” know when there has been a material change in the product or the components of the product?
- Should we test the product (or component parts) from each purchase order/shipment to ensure that the product (or component part) are still representative of those in distribution and that no material change has been made?