The Consumer Product Safety Improvement Act of 2008 (CPSIA) establishes stringent limits on the level of lead permitted in children’s products. At this time, products designed or intended primarily for children 12 years of age or younger may not contain more than 600 parts per million (ppm) of lead. This limit will further reduce to 300 ppm effective August 14, 2009 and, if technologically feasible, to 100 ppm effective August 14, 2011.¹ In addition, children’s products will be subject to the testing and certification requirements for total lead content if the Commission decides to terminate its stay of enforcement of testing and certification requirements after February 10, 2010. The Consumer Product Safety Commission (CPSC) has posted to its Web site a draft final rule on the procedures and requirements for (i) a Commission determination that a material or product does not exceed the lead content limits specified under Section 101(a) of the CPSIA, or (ii) an exclusion of a material or product whose lead content exceeds the CPSIA limits, but would not result in the absorption of any lead into the human body nor would have any other adverse impact on public health or safety. The Commissioners are required to vote on the draft final rule by March 3, 2009. A discussion of the proposed final rule appears below.

What Relief is Available to Companies Manufacturing, Importing, Selling, or Distributing Products that Contain Lead Below the CPSIA Limits or Contain Lead at Levels that Will Not Have Any Impact on Public Health? 

The draft final rule permits interested stakeholders to submit a request for (i) a Commission determination that a product or material does not contain lead in levels that exceed the CPSIA limits, and (ii) an exclusion of a specific product or material from the CPSIA lead requirements, as follows:

• Request for a Commission determination that a product or material does not contain lead levels that exceed the CPSIA limits: CPSC will determine, either upon the request of an interested person or on the Commission’s own initiative, that a material or product does not contain lead levels that exceed the CPSIA limits. The Commission will focus on evaluating those materials that are commodity-like, used across industry in a number of applications, and subject to detailed consensus standards related to lead content and other pertinent properties. Review of individual products of a single manufacturer, however, would be assigned a low priority. CPSC previously released a list of certain natural materials, metals, and alloys whose lead content consistently falls below 300 ppm.

• Request for an exclusion of a specific product or material from the CPSIA lead limits: The CPSIA authorizes the Commission to exclude a specific product or material from the lead limits if, after notice and a hearing, it determines on the basis of the best-available, objective, peer-reviewed, scientific evidence that lead in such product or material will neither (i) result in the absorption of ANY lead into the human body, taking into account normal and reasonably foreseeable use and abuse of such product by a child, including swallowing, mouthing, breaking, or other children’s activities, and the aging of the product, nor (ii) have any other adverse impact on public health or safety.  CPSC interpreted this statutory language as establishing a high standard with the result that any absorption of lead, no matter how insignificant, would be deemed unacceptable. 

What Information is Required to Support a Request for a Determination or Exclusion? 

Requests for (i) a determination that a material or product does not contain lead levels that exceed 600 ppm, 300 ppm, or 100 ppm, as applicable, or (ii) an exclusion of a specific material or product from the CPSIA lead limits must be supported by extensive documentation.  Some of the information that the Commission requires includes:

• Representative data on the lead content of parts of the product or materials used in the production of a product.  According to the preamble to the draft final rule, material safety data sheets (MSDS) will not be sufficient to satisfy the representative testing criteria because they do not show sufficient information regarding lead content.

• All relevant data on manufacturing processes through which lead may be introduced into the material or product.

• An assessment of the likelihood (or lack thereof) that the manufacturing processes will result in lead contamination of a material or product that ordinarily does not contain lead. [Note: This is only required to support a request for a determination.]

• All relevant data on the facilities used to manufacture the material or product, and any other materials used in the product. [Note: This is only required to support a request for a determination.]

• An assessment of the likelihood (or lack thereof) that use of leaded materials in a facility will result in lead contamination of a material or product that ordinarily does not contain lead. [Note: This is only required to support a request for a determination.]

• Detailed information on the test methods relied upon for measuring lead content of products or materials, including the type of equipment used or any other techniques employed and a statement as to why the data is representative of the lead content of such products or materials generally.

• Best-available, objective, peer-reviewed scientific evidence demonstrating that the normal and reasonably foreseeable use and abuse activity by a child (including swallowing, mouthing, breaking, or other children’s activities) and the aging of the material or product for which exclusion is sought, will not result in the absorption of any lead into the human body, nor have any other adverse impact on public health or safety.  This literature should support a request for exclusion that addresses how much lead is present in the product, how much lead comes out of the product, and the conditions under which that may happen and information relating to a child’s interaction, if any, with the product. [Note: This is only required to support a request for exclusion.]

• Any data or information that is unfavorable and reasonably available to the requestor.  To the extent that such information is reasonably available to the requestor, particularly if the information was produced by or presented to the requestor, it must be provided to the Commission.

What are the Commission Procedures for Evaluating a Request for a Determination or Exclusion?

A request will be considered deficient if it fails to include all of the information specified in the draft final rule.  The requestor will be notified of any deficiency and will be permitted to resubmit the request once the deficiency is corrected.  Upon receipt of a complete request for a determination or exclusion, the Commission’s Office of Hazard Identification and Reduction (EXHR) will, to the extent practicable, make an initial recommendation to the Commission within 30 calendar days on whether the request should be granted or denied. The Commission will then vote on the EXHR’s initial recommendation. 

If the Commission votes to grant the request for a determination or exclusion, then it will issue a proposed rulemaking requesting public comment on the basis for its decision.  The EXHR will subsequently review and evaluate any public comments and issue a final recommendation to the Commission, which will vote on the recommendation.

It is important to note that all CPSC requirements related to lead content remain in effect for the applicable material or product until the Commission votes to grant the determination or exclusion.

Please contact any of the individuals below if you would like to discuss submitting a request to CPSC for a determination or exclusion of a product or material.

Related Document:

• Children’s Products Containing Lead; Final Rule: Procedures and Requirements for a Commission Determination or Exclusion

¹ Paint, coatings, or electroplating are not deemed barriers that would make the lead content of a product inaccessible to a child or prevent the absorption of any lead in the human body through normal and reasonably foreseeable use and abuse of the product.

Georgia Ravitz
ravitz.georgia@arentfox.com
202.857.8939

James R. Ravitz
ravitz.james@arentfox.com
202.857.8903

Scott A. Cohn
cohn.scott@arentfox.com
212.484.3984

Robert G. Edwards, PhD
edwards.robert@arentfox.com
202.857.6346

Amy S. Colvin
colvin.amy@arentfox.com
202.857.6338