CPSC Certification Requirements Applicable Only to Importers and Domestic Manufacturers

November 11, 2008

By Michelle L. Butler

We previously posted on the expanded certification requirements mandated by section 102(a)(1) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”).  Today, the Consumer Product Safety Commission (“CPSC”) published on its website an immediate final rule regarding these certification requirements.  CPSC, Final Rule, Certificates of Compliance with Rules under the Consume Pt Safety Act and Similar Rules, Bans, Standards and Regulations under any other Act Enforced by the Consumer Product Safety Commission (Nov. 10, 2008) (the “Final Rule”).  A copy of the document can be found here.  (Due to the federal holiday, the Federal Register was not published today.  We presume that the Final Rule will be presented for pre-publication inspection tomorrow, November 12, 2008, and published in the Federal Register on Thursday, November 13, 2008.)

The Final Rule streamlines the certification requirements of section 14(a) of the Consumer Product Safety Act (“CPSA”).  The CPSC has determined that the sole entity required to issue a certificate for imported products is the importer, and the sole entity required to issue a certificate for domestically produced products is the manufacturer.  The Final Rule states that a certificate for an imported product “must be available to the Commission from the importer as soon as the product or shipment itself is available for inspection in the United States.”   For domestic products, the certificate “must be available to the Commission from the manufacturer prior to distribution into domestic commerce.”   The preamble to the Final Rule notes that, with respect to imports, “after [an] initial period of adjustment, failure to abide by the general certificate requirement will subject shipments to refusal of admission into the country and potential destruction.” 

The Final Rule also provides information pertaining to the content of the certificate.  The CPSC “suggests” that the issuer of a certificate “maintain test records supporting the certification for at least three years.” 

According to the Final Rule, electronic certification satisfies the “accompany” and “furnish” requirements pertaining to the certification.  Specifically, the Final Rule states that:

[a]n electronic certificate satisfies the “accompany” requirement if the certification is identified by a unique identifier and can be accessed via a World Wide Web URL or other electronic means, provided the URL or other electronic means and the unique identifier are created in advance and are available, along with access to the electronic certificate itself, to the Commission or to the Customs authorities as soon as the product or shipment itself is available for inspection.

 “An electronic certification satisfies the ‘furnish’ requirement if the distributor(s) and retailer(s) of the product are provided a reasonable means to access the certificate.”  Further, “[a]n electronic certificate shall have a means to verify the date of its creation or last modification.” 

The CPSC is issuing this rule as an immediately effective final rule due to the short implementation timeline mandated by the CPSIA.  In its justification for an immediate final rule, the CPSC notes that the “certification requirements established by the CPSIA go into effect for products manufactured on or after November 12, 2008.”   The CPSC also justifies the streamlining in the Final Rule based on the multiple short deadlines imposed by the CPSIA, the CPSC’s lack of resources, and confusion over the new certification requirements as evidenced by the many inquiries received by the CPSC.   The CPSC stated that

[w]hile the Commission expects every company to make best efforts to comply promptly with the new general certificate requirements, the Commission’s resource limitations under the continuing resolution will force it to focus more on a product’s compliance with our safety rules.  The certificate is evidence of compliance and therefore it is appropriate to concentrate initially more on the substantive requirements underlying the certificate than on the certificate or the form of the certificate itself.

The preamble also notes that the CPSC recognizes the necessity of clarification for aspects of the certification program, and it will be working to resolve uncertainties, including via posting of additional FAQs. 

Categories: Drug Development