CPSC Advises that the New CSPIA General Conformity Assessment Will Soon Apply to CPSC-Regulated Products

October 12, 2008

On October 2, 2008, the Consumer Product Safety Commission (“CPSC”) held a public meeting on the testing and certification requirements imposed by the recently enacted Consumer Product Safety Improvement Act (“CPSIA”).  A similar meeting was held on September 4, 2008 and several others are planned for the near future.  The meeting included sessions on general conformity certification, laboratory accreditation, and mandatory third-party testing for children’s products, followed by a question and answer period.  Of particular interest was the statement by Gib Mullan, the CPSC Director of Compliance and Field Operations, that the CPSIA’s general conformity certification under section 102 applies to any drug product that is also regulated by the Commission through other laws, such as through the Poison Prevention Packaging Act.  This is true, according to Mr. Mullan, even if the drug is not indicated for use in a pediatric population.  In fact, if the drug is indicated for pediatric use, there may be additional requirements imposed by the CPSIA, such as mandatory third-party testing.  A video of the meeting is available on CPSC’s website. 

Section 102(a)(1) of CPSIA amends section 14(a)(1) of the Consumer Product Safety Act (“CPSA”) to require each manufacturer (including an importer) of any consumer product to issue a certificate that the product complies with CPSC rules under the CPSIA or similar requirements under any of the other Acts administered by the CPSC.  According to the Commission, “the certificate must be based on a test of each product or on a reasonable testing program.  This requirement is effective beginning on November 12, 2008.  There are additional third party testing requirements for children’s products.”

Preceding the October 2 sessions was a welcome by Nancy Nord, Acting Chairman of the CPSC, who emphasized that the CPSIA has ambitious time deadlines and that in an effort to meet these deadlines the CPSC will be publishing regulations via a new process not normally used by CPSC.  Ms. Nord stated that interested parties should pay attention to the Federal Register and the CPSC Website and provide comments quickly so that they receive full consideration by the Commission.  The CPSC recently posted a Request for Comment and Information regarding CPSIA’s Section 102 requirements for certificates for conformity testing and third-party testing.  The post indicates that the CPSC is particularly interested in comments on the use of electronic certificates as well as the issue of multiple certifications for the same product.  The CPSC is accepting comments regarding certification for conformity testing and third-party testing through October 29, 2008.

By John R. Fleder and Serafina E. Lobsenz

Categories: Drug Development