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Notice

Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with the Limits on Total Lead in Children's Products

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Information about this document as published in the Federal Register.

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AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of Requirements.

SUMMARY:

The Consumer Product Safety Commission (“CPSC” or “Commission”) Start Printed Page 55821is issuing a notice of requirements that provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to the limits on total lead in children's products. The Commission is issuing this notice of requirements pursuant to section 14(a)(3)(B)(vi) of the Consumer Product Safety Act (15 U.S.C. 2063(a)(3)(B)(vi)).

DATES:

Effective Date: The requirements for accreditation of third party conformity assessment bodies for testing to the limits on total lead in children's products are effective upon publication of this notice in the Federal Register.

Comments in response to this notice of requirements should be submitted by November 30, 2009. Comments on this notice should be captioned “Third Party Conformity Assessment Body Accreditation Process for the Limits on Total Lead in Children's Products.”

ADDRESSES:

You may submit comments, identified by Docket No. CPSC-2009-0090, by any of the following methods:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

To ensure timely processing of comments, the Commission is no longer accepting comments submitted by electronic mail (e-mail) except through http://www.regulations.gov.

Written Submissions

Submit written submissions in the following way:

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions), preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East-West Highway, Bethesda, MD 20814; telephone (301) 504-7923.

Instructions: All submissions received must include the agency name and docket number for this notice of requirements. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information electronically. Such information should be submitted in writing.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

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FOR FURTHER INFORMATION CONTACT:

Robert “Jay” Howell, Assistant Executive Director for Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814; e-mail rhowell@cpsc.gov.

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SUPPLEMENTARY INFORMATION:

I. Introduction

The Consumer Product Safety Act (“CPSA”), at section 14(a)(3)(B)(vi), as added by section 102(a)(2) of the Consumer Product Safety Improvement Act of 2008 (“CPSIA”), Public Law 110-314, directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies (also referred to as “third party laboratories”) to assess children's products for conformity with “other children's product safety rules.” Section 14(f)(1) of the CPSA defines “children's product safety rule” as “a consumer product safety rule under [the CPSA] or similar rule, regulation, standard, or ban under any other Act enforced by the Commission, including a rule declaring a consumer product to be a banned hazardous product or substance.” Under section 14(a)(3)(A) of the CPSA, each manufacturer (including the importer) or private labeler of products subject to those regulations must have products that are manufactured more than 90 days after the Federal Register publication date of this notice tested by a third party conformity assessment body accredited to do so and must issue a certificate of compliance with the applicable regulations based on that testing. (The Commission notes, however, that in the Federal Register of February 9, 2009 (74 FR 6396), the Commission announced a stay of enforcement of certain provisions of section 14(a) of the CPSA; the stay applies to the testing that would result from this notice of requirements.) Section 14(a)(2) of the CPSA, as added by section 102(a)(2) of the CPSIA, requires that certification be based on testing of sufficient samples of the product, or samples that are identical in all material respects to the product. The Commission also emphasizes that, irrespective of certification, the product in question must comply with applicable CPSC requirements (see, e.g., section 14(h) of the CPSA, as added by section 102(b) of the CPSIA).

The Commission also is recognizing limited circumstances in which it will accept certifications if the product was tested by a third party conformity assessment body that the CPSC accepts as being accredited by December 31, 2009 or 30 days before the Commission terminates the stay of enforcement that was originally announced in the Federal Register on February 9, 2009 (74 FR 6396), whichever date is later. The details regarding those limited circumstances can be found in part IV of this document below.

This notice provides the criteria and process for Commission acceptance of accreditation of third party conformity assessment bodies for testing pursuant to the following test methods:

  • CPSC-CH-E1001-08, Standard Operating Procedure for Determining Total Lead (Pb) in Children's Metal Products (Including Children's Metal Jewelry [1] ), issued December 4, 2008, and
  • CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products, issued February 1, 2009.

For measuring total lead content of homogeneous polymeric materials (including natural and synthetic polymers or plastic materials in children's consumer products), the methods for using x-ray fluorescence spectrometry (XRF) described in CPSC-CH-E1002-08 may be used. Both methods may be freely downloaded from the CPSC Web site at http://www.cpsc.gov/​about/​cpsia/​labaccred.html.

Although section 14(a)(3)(B)(vi) of the CPSA directs the CPSC to publish a notice of requirements for accreditation of third party conformity assessment bodies to assess conformity with “all other children's product safety rules,” this notice of requirements is limited to the test methods identified immediately above. The CPSC acknowledges that the test methods for determining total lead content are not, in themselves, rules, but we believe it is appropriate for the notice of requirements to apply to the CPSC test methods because section 101(g) of the CPSIA considers the lead content restrictions to be “a regulation of the Commission” under the Federal Hazardous Substances Act. Thus, the test methods would be used to assess conformity with the lead requirements.

The CPSC also recognizes that section 14(a)(3)(B)(vi) of the CPSA is captioned as “All Other Children's Product Safety Rules,” but the body of the statutory requirement refers only to “other children's product safety rules.” Nevertheless, section 14(a)(3)(B)(vi) of the CPSA could be construed as Start Printed Page 55822requiring a notice of requirements for “all” other children's product safety rules, rather than a notice of requirements for “some” or “certain” children's product safety rules. However, whether a particular rule represents a “children's product safety rule” may be subject to interpretation, and the Commission staff is continuing to evaluate which rules, regulations, standards, or bans are “children's product safety rules.” The CPSC intends to issue additional notices of requirements for other rules which the Commission determines to be “children's product safety rules.”

The CPSC also advises interested parties that, with respect to the materials which the CPSC has determined not to exceed the lead content limits specified in section 101(a) of the CPSIA, testing by third party conformity assessment bodies is not required to support a finding that a particular material is within the determinations. In the Federal Register of August 26, 2009 (74 FR 43031), the CPSC issued a final rule identifying those materials which do not exceed the lead content limits specified in section 101(a) of the CPSIA (the “determinations rule”). For example, the determinations rule includes natural fibers, such as cotton, in the determinations; this means that a cotton shirt would not need to be tested by a third party conformity assessment body for lead, and it also means that a third party conformity assessment body would not need to test the cotton shirt to show that it is, indeed, made out of cotton. The CPSC reminds interested parties that the obligation to have third party conformity assessment bodies test children's products exists in relation to “children's product safety rules” and that section 14(f)(1) of the Consumer Product Safety Act (CPSA) defines “children's product safety rule” as a consumer product safety rule under the CPSA or “similar rule, regulation, standard, or ban under any other Act enforced by the Commission.” Section 3(a)(6) of the CPSA, in turn, defines “consumer product safety rule,” in part, as a consumer product safety standard * * * or a rule * * * declaring a consumer product a banned hazardous product.” The rule determining that certain materials do not exceed the lead limits in section 101(a) of the CPSIA is not a “consumer product safety rule” as defined by section 3(a)(6) of the CPSA and, therefore, also is not a “children's product safety rule” as defined by section 14(a)(1) of the CPSA. Consequently, to continue using the example of a cotton shirt, the cotton shirt manufacturer could decide, based on its own knowledge and expertise regarding the materials used in its product, that its cotton shirt is, indeed, made of cotton and within the determinations rule. The cotton shirt manufacturer would not need to submit samples of its cotton shirts to a third party conformity assessment body to determine whether the shirts were made of cotton.

This notice of requirements applies to all third party conformity assessment bodies as described in section 14(f)(2) of the CPSA. Generally speaking, such third party conformity assessment bodies are: (1) Third party conformity assessment bodies that are not owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes; (2) “firewalled” conformity assessment bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body for certification purposes and that seek accreditation under the additional statutory criteria for “firewalled” conformity assessment bodies); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government.

The Commission requires baseline accreditation of each category of third party conformity assessment body to the International Organization for Standardization (“ISO”) Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories.” The accreditation must be by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation-Mutual Recognition Arrangement (“ILAC-MRA”), and the scope of the accreditation must include testing for any of the test methods identified earlier in part I of this document for which the third party conformity assessment body seeks to be accredited.

(A description of the history and content of the ILAC-MRA approach and of the requirements of the ISO/IEC 17025:2005 laboratory accreditation standard is provided in the CPSC staff briefing memorandum “Third Party Conformity Assessment Body Accreditation Requirements for Testing Compliance with 16 CFR Part 1501 (Small Parts Regulation),” dated November 2008 and available on the CPSC's Web site at http://www.cpsc.gov/​library/​foia/​foia09/​brief/​smallparts.pdf.)

The Commission has established an electronic accreditation registration and listing system that can be accessed via its Web site.

This notice of requirements is effective on October 29, 2009. However, the CPSC will stay its enforcement of this notice of requirements at least until February 10, 2010; the date reflects the stay of enforcement that the CPSC published in the Federal Register on February 9, 2009 (74 FR 6396). Nevertheless, the Commission invites comments on the accreditation procedures as they apply to that testing and on the accreditation approach in general.

This notice of requirements is exempt from the notice and comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 553 (see section 14(a)(3)(G) of the CPSA, as added by section 102(a)(2) of the CPSIA (15 U.S.C. 2063(a)(3)(G))).

II. Accreditation Requirements

A. Baseline Third Party Conformity Assessment Body Accreditation Requirements

For a third party conformity assessment body to be accredited to test children's products for conformity with the test methods identified earlier in part I of this document, it must be accredited by an ILAC-MRA signatory accrediting body, and the accreditation must be registered with, and accepted by, the Commission. A listing of ILAC-MRA signatory accrediting bodies is available on the Internet at http://ilac.org/​membersbycategory.html. The accreditation must be to ISO Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories,” and the scope of the accreditation must expressly include testing to CPSC-CH-E1001-08, Standard Operating Procedure for Determining Total Lead (Pb) in Children's Metal Products (Including Children's Metal Jewelry), issued December 4, 2008, and/or CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products, issued February 1, 2009. A true copy, in English, of the accreditation and scope documents demonstrating compliance with these requirements must be registered with the Commission electronically. The additional requirements for accreditation of firewalled and governmental conformity assessment bodies are described in parts II.B and II.C of this document below.

The Commission will maintain on its Web site an up-to-date listing of third party conformity assessment bodies whose accreditations it has accepted and the scope of each accreditation. Start Printed Page 55823Subject to the limited provisions for acceptance of “retrospective” testing performed by other than firewalled conformity assessment bodies noted in part IV below, once the Commission adds a third party conformity assessment body to that list, the third party conformity assessment body may commence testing of children's products to support certification by the manufacturer or private labeler of compliance with the test methods identified earlier in part I of this document.

B. Additional Accreditation Requirements for Firewalled Conformity Assessment Bodies

In addition to the baseline accreditation requirements in part II.A of this document above, firewalled conformity assessment bodies seeking accredited status must submit to the Commission copies, in English, of their training documents showing how employees are trained to notify the Commission immediately and confidentially of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the third party conformity assessment body's test results. This additional requirement applies to any third party conformity assessment body in which a manufacturer or private labeler of a children's product to be tested by the third party conformity assessment body owns an interest of ten percent or more. While the Commission is not addressing common parentage of a third party conformity assessment body and a children's product manufacturer at this time, it will be vigilant to see if this issue needs to be addressed in the future.

As required by section 14(f)(2)(D) of the CPSA, the Commission must formally accept, by order, the accreditation application of a third party conformity assessment body before the third party conformity assessment body can become an accredited firewalled conformity assessment body.

C. Additional Accreditation Requirements for Governmental Conformity Assessment Bodies

In addition to the baseline accreditation requirements of part II.A of this document above, the CPSIA permits accreditation of a third party conformity assessment body owned or controlled, in whole or in part, by a government if:

  • To the extent practicable, manufacturers or private labelers located in any nation are permitted to choose conformity assessment bodies that are not owned or controlled by the government of that nation;
  • The third party conformity assessment body's testing results are not subject to undue influence by any other person, including another governmental entity;
  • The third party conformity assessment body is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited;
  • The third party conformity assessment body's testing results are accorded no greater weight by other governmental authorities than those of other accredited third party conformity assessment bodies ; and
  • The third party conformity assessment body does not exercise undue influence over other governmental authorities on matters affecting its operations or on decisions by other governmental authorities controlling distribution of products based on outcomes of the third party conformity assessment body's conformity assessments.

The Commission will accept the accreditation of a governmental third party conformity assessment body if it meets the baseline accreditation requirements of part II.A of this document above and meets the additional conditions stated here. To obtain this assurance, CPSC staff will engage the governmental entities relevant to the accreditation request.

III. How Does a Third Party Conformity Assessment Body Apply for Acceptance of its Accreditation?

The Commission has established an electronic accreditation acceptance and registration system accessed via the Commission's Internet site at http://www.cpsc.gov/​businfo/​labaccred.html. The applicant provides, in English, basic identifying information concerning its location, the type of accreditation it is seeking, and electronic copies of its ILAC-MRA accreditation certificate and scope statement, and firewalled third party conformity assessment body training document(s), if relevant.

Commission staff will review the submission for accuracy and completeness. In the case of baseline third party conformity assessment bodies and government-owned or government-operated conformity assessment bodies, when that review and any necessary discussions with the applicant are satisfactorily completed, the third party conformity assessment body in question is added to the CPSC's list of accredited third party conformity assessment bodies at http://www.cpsc.gov/​businfo/​labaccred.html. In the case of a firewalled conformity assessment body seeking accredited status, when the staff's review is complete, the staff transmits its recommendation on accreditation to the Commission for consideration. (A third party conformity assessment body that may ultimately seek acceptance as a firewalled third party conformity assessment body also can initially request acceptance as a third party conformity assessment body accredited for testing of children's products other than those of its owners.) If the Commission accepts a staff recommendation to accredit a firewalled conformity assessment body, the firewalled conformity assessment body will then be added to the CPSC's list of accredited third party conformity assessment bodies. In each case, the Commission will notify the third party conformity assessment body electronically of acceptance of its accreditation. All information to support an accreditation acceptance request must be provided in the English language.

Subject to the limited provisions for acceptance of “retrospective” testing performed by other than accredited firewalled conformity assessment bodies noted in part IV of this document below, once the Commission adds a third party conformity assessment body to the list, the third party conformity assessment body may then begin testing of children's products to support certification of compliance with the regulations identified earlier in part I of this document for which it has been accredited.

IV. Limited Acceptance of Children's Product Certifications Based on Third Party Conformity Assessment Body Testing Prior to the Commission's Acceptance of Accreditation

The Commission will accept a certificate of compliance to the total lead content limits established by the CPSIA for children's products and tested in accordance with CPSC-CH-E1001-08, Standard Operating Procedure for Determining Total Lead (Pb) in Children's Metal Products (Including Children's Metal Jewelry), issued December 4, 2008, and/or CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products, issued February 1, 2009, based on testing performed by an accredited third party conformity assessment body (including a government-owned conformity assessment body, a government controlled conformity Start Printed Page 55824assessment body, and a firewalled conformity assessment body) if:

  • At the time of product testing, the product was tested by a third party conformity assessment body that was ISO/IEC 17025 accredited by an ILAC-MRA member at the time of the test. For firewalled conformity assessment bodies, the firewalled conformity assessment body must be one that the Commission has accredited by order at or before the time the product was tested, even if the order did not include the test methods specified in this notice. If the third party conformity assessment body has not been accredited by a Commission order as a firewalled conformity assessment body, the Commission will not accept a certificate of compliance based on testing performed by the third party conformity assessment body before it is accredited, by Commission order, as a firewalled conformity assessment body.
  • The third party conformity assessment body's application for testing for total lead content in children's products using the test methods identified in this document is accepted by the CPSC by December 31, 2009 or 30 days prior to the date the Commission terminates the stay of enforcement that was originally announced in the Federal Register on February 9, 2009 (74 FR 6396) (whichever is the later date);
  • The product was tested on or after December 4, 2008 with respect to CPSC test method CPSC-CH-E1001-08, Standard Operating Procedure for Determining Total Lead (Pb) in Children's Metal Products (Including Children's Metal Jewelry) and/or was tested on or after February 1, 2009 with respect to CPSC test method CPSC-CH-E1002-08, Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products. For example, a children's product constructed completely from metal materials must be tested in accordance with CPSC-CH-E1001-08. A children's product constructed completely from non-metal materials must be tested in accordance with CPSC-CH-E1002-08. A children's product constructed from a combination of metal and non-metal materials must be tested in accordance with both test methods.
  • The accreditation scope in effect for the third party conformity assessment body at that time expressly included testing to the test method(s) identified earlier in part I of this document;
  • The test results show compliance with the applicable current standards and regulations (i.e., the total lead limits in effect on the day the certification is presented, rather than those in effect on the day that the testing was performed); and
  • The third party conformity assessment body's accreditation and inclusion of the test method(s) for determining total lead content (identified earlier in part I of this document) in its scope remain in effect through the effective date for mandatory third party testing and manufacturer/private labeler certification for the total lead limit requirements for children's products.
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Dated: October 23, 2009.

Todd A. Stevenson,

Secretary, Consumer Product Safety Commission.

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Footnotes

1.  Due to the Commission's stay of enforcement that appeared in the Federal Register on February 9, 2009 (74 FR 6396), at the time when the stay of enforcement was published, only accessible, metallic parts of children's metal jewelry were required to be tested. When the stay of enforcement is lifted, all accessible parts of children's metal jewelry, metals and non-metals, will need to comply with the applicable regulations.

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[FR Doc. E9-26073 Filed 10-28-09; 8:45 am]

BILLING CODE 6355-01-P