Procedures for Petitioning for a Functional Purpose Exception to the Lead Content Requirement for Children's Products

This is CPSC guidance for manufacturers to petition for a functional purpose exception to the lead content requirement for children's products.
July 12, 2013

This is CPSC guidance for manufacturers to petition for a functional purpose exception to the lead content requirement for children's products

 

Background

 

The Consumer Product Safety Improvement Act of 2008 (CPSIA) requires that, with a few limited exceptions, all children's products manufactured after August 14, 2011, must not contain more than 100 parts per million (ppm) of total lead content in accessible component parts.  As amended by Public Law 112-28 (PL 112-28), section 101(b)(1) of the CPSIA provides for a functional purpose exception, under certain circumstances, to the lead content requirement for children’s products.  On July 10, 2013, the Commission amended its regulations at 16 C.F.R. § 1500.90 to reflect the statutory requirements under section 101(b)(1) of the CPSIA (78 FR 41298).   

 

Under section 101(b)(1)(A) of the CPSIA, a functional purpose exception to the lead content limit for a specific product, class of product, material, or component part may be granted if, after notice and a hearing, the U. S. Consumer Product Safety Commission (CPSC, Commission) determines that:

 

  • the product, class of product, material, or component part requires the inclusion of lead because it is not practicable or not technologically feasible to manufacture such product, class of product, material, or component part by removing the excessive lead or by making the lead inaccessible;
  •  

  • the product, class of product, material, or component part is not likely to be placed in the mouth or ingested, taking into account normal and reasonably foreseeable use and abuse of such product, class of product, material, or component part by a child; and
  •  

  • an exception for the product, class of product, material, or component part will have no measurable adverse effect on public health or safety, taking into account normal and reasonably foreseeable use and abuse.

 

Under section 101(b)(1)(B), “no measurable adverse effect on public health or safety” means that there is no measurable increase in blood lead levels of a child.  The Commission may adopt an alternative method of measurement, other than blood lead levels, if it determines, after notice and a hearing, that such alternative method is a better scientific method for measuring an adverse effect on public health and safety.

 

Procedures for Granting an Exception

 

A.How to submit a petition for an exception

 

A party seeking a functional purpose exception may submit a petition to:

Office of the Secretary,

U.S. Consumer Product Safety Commission,

 

E-mail: cpsc-os@cpsc.gov;

 

Postal Mail:

Room 820

4330 East West Highway

Bethesda, MD 20814

 

Phone: (301) 504-7923

 

Once a petition is received, the Commission will publish notice of the petition in the Federal Register and provide an opportunity for public comment.  Staff will review the information submitted with the request for an exception and assess whether additional information is required to evaluate the request.  Once staff determines that staff has received a completed request, staff will provide a recommendation to the Commission on whether to grant, deny, or take other action on the petition within 90 days after the close of the public comment period, if possible.  If the Commission votes to grant the petition for a functional purpose exception, the Commission will publish notice of the grant of the exception in the Federal Register.  If the Commission votes to deny or defer action on the petition for a functional purpose exception, the Commission will inform the petitioner by letter from the Office of the Secretary. 

 

B. What to include in the petition

 

A petition for a functional purpose exception should address each of the three general statutory criteria for exceptions in CPSIA section 101(b)(1)(A) through technical analyses of the product, class of product, or component part, and the materials used to manufacture the product.  The petition should address the intended and likely users of the product and the users’ likely interactions with the product.  Finally, the petition should address the level of exposure to lead that could result from children’s use of the product.  See section III, below, “Factors for Consideration.”

 

CPSIA section 101(b)(1)(C) provides that a party seeking a functional purpose exception has the burden of demonstrating that it meets the requirements with respect to every accessible component part or accessible material of the product.  The Commission may base its decision solely on the data and information presented by the party seeking the exception and any data and information received through notice and a hearing.  In addition, a party seeking an exception may rely on any nonproprietary information submitted by any other party seeking such an exception, and such information shall be considered part of the record presented by the party who relies on that information.

 

C. Example

 

An example of a functional purpose exception request is the Joseph L. Ertl, Inc., Scale Models and Dyersville Die Cast, request for a functional purpose exception for its die cast ride-on children’s tractors, submitted September 29, 2011.  Any party interested in the exceptions provision of the CPSIA may refer to this request, as well as to staff’s technical evaluation of the request included in the staff briefing package, and the Commission’s decision granting the exception, published in a notice in the Federal Register.

 

Factors for Consideration

 

The Commission may grant an exception based on a determination that the three statutory criteria described in Section 1 of this document are met.

 

Information concerning each of the three criteria should be based on a case-by-case evaluation of the characteristics of the specific product, class of product, material, or component part; analysis of the behaviors and characteristics of the children expected to use the product; and the level of exposure to lead that could result from children’s use of the product.

 

A. Evaluate whether the product, class of product, material, or component part requires the inclusion of lead because it is not practicable or not technologically feasible to manufacture it without the excess lead or make the lead inaccessible.

 

The evaluation should include  a detailed description of the product, component part, class of product or material, and representative data on the lead content of component parts of the product or materials used in the production of the product.  The evaluation specifically should address both the practicability and technological feasibility of the 100 ppm lead content requirement.  The evaluation should include an explanation of the need for lead at concentrations that exceed the 100 ppm content limit, and should include information about the lowest lead content level that is practicable and/or technologically feasible to manufacture the product.

 

  1.  Practicable

     

    • the commercial availability of the material or component part with no more than 100 ppm lead;
    • the availability of a substitute material with no more than 100 ppm lead;
    • the costs associated with using materials or component parts containing no more than 100 ppm lead;
    • the accessibility of the component part or material, and the capability of making the component part inaccessible to a child; and
    • other factors, on a case-by-case basis, depending on the material or component part.
  2.  

    Whether a specific product or action is “practicable” refers to the capability of the desired action being done, effected, or put into practice.  In this context, a petition should include data and information that show that it is not practicable to meet the lead content limit of 100 ppm for the specific product, material, or accessible component part of the product.  Among the factors that may be considered with respect to practicability are:

     

  3. Technologically Feasible

 

The technological feasibility of the conformity of a material, component part, or product to the 100 ppm lead content requirement, in this case, refers to the four factors described in section 101(d) of the CPSIA (15 U.S.C. 1278a(d)). 

 

Those factors are: Section 101(d) of the CPSIA (15 U.S.C. 1278a(d)) provides that a lead limit shall be deemed technologically feasible with regard to a product or product category if:

 

  1. a product that complies with the limit is commercially available in the product category;
  2.  

  3. technology to comply with the limit is commercially available to manufacturers, or is otherwise available within the common meaning of the term;
  4.  

  5. industrial strategies or devices have been developed that are capable, or will be capable, of achieving such a limit by the effective date of the limit, and that companies, acting in good faith, are generally capable of adopting; or
  6.  

  7. alternative practices, best practices, or other operational changes would allow the manufacturer to comply with the limit.

 

A petition seeking a functional exception should address all four factors that define “technological feasibility” to address the technological feasibility of compliance of a specific product, material, or accessible component part of the product to meet the lead content limit of 100 ppm.

 

 

B. Evaluate whether the product or component part is likely to be placed in the mouth or ingested.

 

The evaluation should include a detailed description of the physical characteristics of the product and its lead-containing component part(s) and how a child is likely to use or interact with the product.  The evaluation specifically should address:

  1. the physical dimensions of the product or component part, and the location and physical orientation of the lead-containing component part(s) that are accessible to a child;
  2.  

  3. the expected consumers of the product, including ages or age ranges, and their expected behaviors and interactions with the product; and
  4.  

  5. whether the lead-containing product or component part(s) is likely to be (a) placed in the mouth, or (b) ingested, considering normal and reasonably foreseeable use and abuse of the product, due to its size or the possibility of breaking the product or component part(s), and whether such activity is intended or foreseeable during the use of the product.

 

C.     Evaluate the potential measurable adverse effect on public health, by evaluating the potential for a measurable increase in blood lead levels of a child.

 

The evaluation should include an assessment of the potential exposure to the lead that is present in the product or component part(s) in concentrations exceeding 100 ppm resulting from use of the product.  The quantitative analysis specifically should address:

     

  1. how a child uses a product, including touching, handling, grasping, pushing, and pulling with hands, feet, or other means;
  2.  

  3. the frequency, duration, and other characteristics of normal and reasonably foreseeable use and abuse;
  4.  

  5. the effects on potential lead exposure of aging, weathering, wear, and other physical actions on the product;
  6.  

  7. measurements of the amount of lead that can be transferred from the lead-containing product or component part(s) during normal and reasonably foreseeable use and abuse of the product by a child, such as to the hands, and the amount of lead that could subsequently be transferred to the mouth and ingested; and
  8.  

  9. estimates of the daily exposure to lead from children’s use of the product based on the laboratory analyses of the product and the assessment of children’s use of, and interactions with, the product.

 

CPSC staff prepared a technical analysis of available information about the toxicology of lead and the effect of lead exposure on blood lead levels of a child.  Staff recommended for purposes of evaluating children’s products for an exception from the CPSIA lead limit, that the statutory condition that a product “will have no measurable adverse effect on public health or safety” is met if a potential exposure to lead from the product is estimated to result in an increase in a child’s blood lead level of less than 0.8 μg/dL.  The level of exposure that would be associated with such an increase is about 2.2 μg per day.  The estimate of exposure to lead from children’s use of a product can be compared to 2.2 μg per day as part of the evaluation of whether the possible exception to the lead content limit will have no measurable adverse effect on public health or safety.