CPSC Issues Proposed Rulemakings to Implement Various CPSIA Provisions

January 16, 2009

By Carrie S. Martin & Anne Marie Murphy

As we have previously reported, the Consumer Product Safety Improvement Act of 2008 (“CPSIA”) makes a number of changes to the laws enforced by the Consumer Product Safety Commission (“CPSC”).  Among those changes are new limits on the amount of lead allowed in consumer products designed or intended primarily for children 12 years old and younger (i.e., children’s products).  (Note that the statutory definition of consumer products, and hence children’s products, excludes drugs, devices, or cosmetics.)  Specifically, Section 101 of the CPSIA states that a children’s product will be considered a banned hazardous substance under the Federal Hazardous Substances Act unless it contains no more than 600 ppm of lead as of February 10, 2009; no more than 300 ppm of lead as of August 14, 2009; and no more than 100 ppm of lead as of August 14, 2011 (if such a low level is technically feasible).  The law also allows the CPSC to exempt certain products from the lead requirements on its own initiative or upon the request of an “interested person.”  If the CPSC determines a children’s product is not subject to the lead requirements, it is exempt from the mandatory testing requirements in Section 102 of the CPSIA.

In order to implement certain provisions, the CPSC recently published in the Federal Register the following four notices of proposed rulemaking:  

(1)  Notice of proposed rulemaking regarding proposed lead content limits on certain materials or products (74 Fed. Reg. 2433 (Jan. 15, 2009));

(2)  Notice of a proposed interpretative rule on inaccessible component parts (74 Fed. Reg. 2439 (Jan. 15, 2009));

(3)  Notice of proposed rulemaking regarding exemptions for certain electronic devices (74 Fed. Reg. 2435 (Jan. 15, 2009)); and

(4)  Notice of proposed procedures and requirements regarding a CPSC “determination” or “exclusion” (74 Fed. Reg. 2428 (Jan. 15, 2009)).

In the first proposed rule, the CPSC exercises its authority to identify material or products that inherently do not contain lead or that do not exceed the 600 ppm or 300 ppm limits set forth in Section 101(a).  Among those materials identified are certain precious and semi-precious gemstones, wood, natural fibers (e.g., cotton, silk, wool, linen), and other “natural material” such as feather, fur, and untreated leather.  The materials do not qualify, however, if they have been treated with materials or chemicals such as pigments, dyes, coatings, or have undergone any processes that could add lead to the product. 

The second proposed rule provides guidance on how the CPSC will assess whether a component part of a children’s product is “inaccessible” and therefore exempt from testing requirements in Section 101(a) of the CPSIA.  The Agency proposes to use tests currently in CPSC regulations, including the “sharp points or edges” test in 16 C.F.R. §§ 1500.48-1500.49 and the “use and abuse tests” under 16 C.F.R. §§ 1500.50-1500.53, with some exceptions.   

In the third proposed rule, the CPSC explains that it has determined, after public comment, that it is not technologically feasible for certain electronic devices to comply with the lead limits in Section 101(a).  These devices include components of electronic devices that are removable or replaceable, such as batteries or light bulbs, and that are inaccessible when the product is assembled in functional form.  The proposed exemption also includes any electronic devices exempted under the Annex to the European Union Directive 2002/95/EC.  In addition, the proposed rule explains how to minimize the exposure to and accessibility of lead in such electronic devices and provides a schedule for achieving compliance. 

In the fourth proposed rule, the CPSC sets forth how an interested person may request a determination that a product or material either (1) does not have lead levels over 600 ppm, 300 ppm, or 100 ppm or (2) should be excluded from the lead limits altogether.  Both requests may be sent electronically or in paper form and must include supporting data.  In addition, for a request for exclusion, the request must be based on the “best-available, objective, peer-reviewed, scientific evidence” that any lead in the product or material would not be absorbed by the body or have an adverse effect on public health or safety.  The request for exclusion must also include unfavorable evidence if it is “reasonably available to the requestor.” 

While none of these efforts provides immediate relief to the regulated industry, they evidence the CPSC’s willingness to take action to lessen the regulatory burden of the CPSIA.  These efforts are encouraging given that certain companies would likely struggle to comply with the new requirements and remain solvent.

Comments on these notices must be received by February 17, 2009.  They may be submitted via mail, e-mail, or fax. 

Categories: Drug Development