Requirements Pertaining to Third Party Conformity Assessment Bodies

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1112 and 1118

[CPSC Docket No. CPSC-2012-0026]

Requirements Pertaining to Third Party Conformity Assessment Bodies

AGENCY:

Consumer Product Safety Commission.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The Consumer Product Safety Commission (“CPSC,” “Commission,” or “we”) is issuing a proposed rule that would establish the requirements pertaining to the third party conformity assessment bodies (or “laboratories”) that are authorized to test children's products in support of the certification required by the Consumer Product Safety Act (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA). The proposed rule would establish the general requirements concerning third party conformity assessment bodies, such as the requirements and procedures for CPSC acceptance of the accreditation of a third party conformity assessment body, and it would address adverse actions against CPSC-accepted third party conformity assessment bodies. The proposed rule also would amend the audit requirements for third party conformity assessment bodies and would amend the Commission's regulation on inspections.

DATES:

Comments in response to this notice of proposed rulemaking must be received by August 7, 2012.

ADDRESSES:

Comments related to the Paperwork Reduction Act aspects of the instructional literature and marking requirements of the proposed rule should be directed to the Office of Information and Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to

oira_submission@omb.eop.gov.

You may submit comments, identified by Docket No. CPSC-2012-0026 by either of the following methods:

•

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 (email) except through

http://www.regulations.gov.

•

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions) preferably in five copies, to:

Office of the Secretary, U.S. Consumer Product Safety Commission, Room 820, 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. All comments received may be posted without change to

http://www.regulations.gov

, including any personal information provided. Do not submit confidential business information, trade secret information, or other sensitive or protected information (such as a Social Security Number) electronically; if furnished at all, 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.

FOR FURTHER INFORMATION CONTACT:

Randy Butturini, Project Manager, Office of Hazard Identification and Reduction, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 301-504-7562; email:

RButturini@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background: Statutory Provisions

Section 14(a)(1) of the CPSA (15 U.S.C. 2063(a)(1)), as amended by the CPSIA (Pub. L. 110-314, 122 Stat. 3016), requires that the manufacturer and the private labeler, if any, of a product that is subject to an applicable consumer product safety rule under the CPSA, or any similar rule, ban, standard, or regulation under any other Act enforced by the CPSC, issue a General Conformity Certificate. The General Conformity Certificate certifies “based on a test of each product or upon a reasonable testing program, that such product complies with all rules, bans, standards, or regulations applicable to the product under this Act or any other Act enforced by the Commission,” and it specifies each rule, ban, standard, or regulation applicable to the product. 15 U.S.C. 2063(a)(1)(A).

Section 14(a)(2) of the CPSA states that, for any children's product that is subject to a children's product safety rule, every manufacturer of such children's product (and the private labeler if the children's product bears a private label) shall submit sufficient samples of the product, or samples that are identical in all material respects to the product, to an accredited third party conformity assessment body (or, “laboratory”) to be tested for compliance with such children's product safety rule. Section 14(a)(2)(B) of the CPSA requires the manufacturer or private labeler, based on such testing, to issue a certificate (“Children's Product Certificate”) certifying that such product complies with the children's product safety rule. Section 14(h) of the CPSA clarifies that, irrespective of certification, the product in question must actually comply with all applicable rules, regulations, standards, or bans enforced by the CPSC.

Section 14(a)(3) of the CPSA establishes various timelines for accreditation of the laboratories that may conduct third party tests of children's products and requires the Commission to publish “a notice of the requirements for accreditation of third party conformity assessment bodies to assess conformity” with specific laws or regulations. Under section 14(a)(3)(A) of the CPSA, the requirement for a manufacturer or private labeler of a children's product subject to a children's product safety rule to issue a certificate based on third party testing does not commence until “more than 90 days” after the Commission publishes a notice of requirements pertaining to the regulation or standard to which the children's product is subject.

The Commission has published several notices of requirements in the

Federal Register

.

See, e.g.,

73 FR 54564 (September 22, 2008) (Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with Part 1303 of Title 16, Code of Federal Regulations); 74 FR 45428 (September 2, 2009) (Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity with Parts 1203, 1510, 1512, and/or 1513 and § 1500.86(a)(7) and/or (a)(8) of Title 16, Code of Federal Regulations); 75 FR 70911 (November 19, 2010) (Third Party Testing for Certain Children's Products; Children's Sleepwear, Sizes 0 Through 6X and 7 Through 14: Requirements for Accreditation of Third Party Conformity Assessment Bodies). We invited public comment on most, but not all, notices of requirements. In section III of this preamble, we summarize and respond to those comments. Section 14(a)(3)(C) of the CPSA provides that the Commission may either accredit laboratories itself or may designate an independent accreditation organization to conduct the accreditations. Section 14(a)(3)(E) of the CPSA requires that the Commission maintain on its Web site an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules.

Section 14(i)(1) of the CPSA requires the Commission to establish “requirements for the periodic audit of third party conformity assessment bodies as a condition for the continuing accreditation of such conformity assessment bodies” under section

14(a)(3)(C) of the CPSA. Section 14(e) of the CPSA addresses Commission withdrawal and suspension of the accreditation (or its acceptance of the accreditation) of a laboratory.

Section 14(f)(2)(A) of the CPSA defines a “third party conformity assessment body” to mean a conformity assessment body that is not owned, managed, or controlled by the manufacturer or private labeler of a product assessed by the laboratory, unless such a laboratory has satisfied certain statutory criteria. Section 14(f)(2)(D) of the CPSA provides that a laboratory owned, managed, or controlled by a manufacturer or private labeler may be accepted by the Commission if the Commission makes certain findings, by order, concerning the laboratory's protections against undue influence by the manufacturer, private labeler, or other interested parties. In that case the laboratory is considered “firewalled.” Similarly, section 14(f)(2)(B) of the CPSA lists five criteria that a conformity assessment body owned or controlled in whole or in part by a government (or “governmental laboratory”) must satisfy for its accreditation to be accepted by the CPSC.

This proposed rule, if finalized, would establish the requirements related to CPSC acceptance of the accreditation of a laboratory for purposes of testing children's products under section 14 of the CPSA. The proposed requirements would be largely the same as the requirements that the CPSC has been using since the CPSIA's passage in August 2008. Among other things, the proposed rule also would delineate how a laboratory may voluntarily discontinue its participation with the CPSC, and it would establish the procedures for the suspension and/or withdrawal of CPSC acceptance of the accreditation of a laboratory. This proposed rule also would amend our rule titled, “Audit Requirements for Third Party Conformity Assessment Bodies” (“audit final rule”), which implements section 14(i)(1) of the CPSA, and is published elsewhere in this issue of the

Federal Register

. Finally, the proposed rule would make particular conforming amendments to 16 CFR 1118.2(a).

II. Background: The CPSC Third Party Conformity Assessment Body Program, to Date

We published 19 notices of requirements between August 14, 2008 and August 14, 2011.

The notices of requirements established the criteria and process for CPSC acceptance of accreditation of laboratories for testing children's products under section 14 of the CPSA. Each notice of requirements was specific to particular CPSC rules, bans, standards, or regulations, and/or it was specific to a standard established by the CPSIA. We have published the following notices of requirements:

• Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity With Part 1303 of Title 16, Code of Federal Regulations, 73 FR 54564 (Sept. 22, 2008).

• Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity With Part 1508, Part 1509, and/or Part 1511 of Title 16, Code of Federal Regulations, 73 FR 62965 (Oct. 22, 2008).

• Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity With Part 1501 of Title 16, Code of Federal Regulations, 73 FR 67838 (Nov. 17, 2008).

• Accreditation Requirements for Third Party Conformity Assessment Bodies to Test to the Requirements for Lead Content in Children's Metal Jewelry as Established by the Consumer Product Safety Improvement Act of 2008, 73 FR 78331 (Dec. 22, 2008).

• Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity With Parts 1203, 1510, 1512, and/or 1513 and Section 1500.86(a)(7) and/or (a)(8) of Title 16, Code of Federal Regulations, 74 FR 45428 (Sept. 2, 2009).

• 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, 74 FR 55820 (Oct. 29, 2009).

• Third Party Testing for Certain Children's Products; Notice of Requirements for Accreditation of Third Party Conformity Assessment Bodies to Assess Conformity With Part 1505 and/or § 1500.86(a)(5) of Title 16, Code of Federal Regulations, 75 FR 22746 (April 30, 2010).

• Third Party Testing for Certain Children's Products; Infant Bath Seats: Requirements for Accreditation of Third Party Conformity, 75 FR 31688 (June 4, 2010); correction, 75 FR 33683 (June 15, 2010).

• Third Party Testing for Certain Children's Products; Infant Walkers: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 35282 (June 21, 2010).

• Third Party Testing for Certain Children's Products; Carpets and Rugs: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 42315 (July 21, 2010).

• Third Party Testing for Certain Children's Products; Vinyl Plastic Film: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 42311 (July 21, 2010).

• Third Party Testing for Certain Children's Products; Mattresses, Mattress Pads, and/or Mattress Sets: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 51020 (Aug. 18, 2010).

• Third Party Testing for Certain Children's Products; Clothing Textiles: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 51016 (Aug. 18, 2010).

• Third Party Testing for Certain Children's Products; Youth All-Terrain Vehicles: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 52616 (Aug. 27, 2010).

• Third Party Testing for Certain Children's Products; Children's Sleepwear, Sizes 0 Through 6X and 7 Through 14: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 70911 (Nov. 19, 2010).

• Third Party Testing for Certain Children's Products; Full-Size Baby Cribs and Non-Full-Size Baby Cribs: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 75 FR 81789 (Dec. 28, 2010).

• Third Party Testing for Certain Children's Products; Toddler Beds: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 76 FR 22030 (April 20, 2011).

• Third Party Testing for Certain Children's Products; Toys: Requirements for Accreditation of Third Party Conformity Assessment Bodies, 76 FR 46598 (Aug. 3, 2011).

• 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 Phthalates in Children's Toys and Child Care Articles, 76 FR 49286 (Aug. 10, 2011).

The notices of requirements explained the three types of third party conformity assessment bodies contemplated by section 14 of the CPSA: (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 (“independent” laboratories); (2) “firewalled” conformity assessment bodies (those that are owned, managed, or controlled by a manufacturer or private labeler of the children's product); and (3) third party conformity assessment bodies owned or controlled, in whole or in part, by a government (“governmental laboratories”).

The notices of requirements have stated that, for a third party conformity assessment body to be accredited to test children's products under section 14 of the CPSA, it must be accredited to the International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) Standard 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). A listing of ILAC-MRA signatory accreditation bodies is available on the Internet at:

http://ilac.org/membersbycategory.html.

The scope of the laboratory's accreditation must include testing to a specific regulation or test method that has been the subject of a notice of requirements.

(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 Regulations),” dated November 2008, and available on the CPSC's Web site at:

http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.

)

The notices of requirements have stated that the CPSC maintains on its Web site an up-to-date listing of laboratories whose accreditation it has accepted, and the scope of each accreditation. Once we add a laboratory to that list, the laboratory may begin testing children's products to any test method or regulation included in the laboratory's scope of accreditation on the CPSC list, to support a Children's Product Certificate.

In addition to the baseline accreditation requirements, the notices of requirements have provided that firewalled laboratories must submit to the CPSC, copies, in English, of their training documents, showing how employees are trained that they may notify the CPSC immediately of any attempt by the manufacturer, private labeler, or other interested party to hide or exert undue influence over the laboratory's test results. Employees also must be trained that their report of alleged undue influence may be reported to the CPSC confidentially. (The notices of requirements stated that firewalled applicants must submit “training documents showing how employees are trained to notify the CPSC immediately and confidentially of any attempt * * * to hide or exert undue influence.” To be more consistent with the statute, we are hereby describing this requirement as a need for the firewalled applicant to train employees that they may notify the CPSC immediately, and that a report to the CPSC may be confidential. The laboratory must have established procedures to ensure that an employee may report an allegation of undue influence to the CPSC and may do so confidentially.

See

15 U.S.C. 2063(f)(2)(D)(ii)(III). Submission of training documents evidencing such policies is required. Additionally, the statute imposes a duty on the laboratory to have procedures in place to ensure that the CPSC is notified immediately of any attempt at undue influence,

see

15 U.S.C. 2063(f)(2)(D)(ii). However, we do not interpret the statute as requiring an individual employee to contact the CPSC. Accordingly, the change in phrasing increases consistency with the statute.) These additional requirements have applied to any laboratory in which a manufacturer or private labeler of a children's product to be tested by the laboratory owns an interest of 10 percent or more.

With regard to governmental laboratories, the notices of requirements have reiterated the five criteria from section 14(f)(2)(B) of the CPSA that must be satisfied for the CPSC to accept the accreditation of a governmental laboratory:

• 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 whose accreditation has been accepted by the CPSC;

• The third party conformity assessment body's testing results are accorded no greater weight by other governmental authorities than those of other third party conformity assessment bodies whose accreditation has been accepted by the CPSC; 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 notices of requirements have explained that CPSC staff will engage the governmental entities relevant to the accreditation request to obtain assurances that the statutory criteria are satisfied.

The notices of requirements also have explained that we have established an electronic accreditation acceptance and registration system accessed via the CPSC's Web site site at:

http://www.cpsc.gov/about/cpsia/labaccred.html.

CPSC Form 223, the application form for laboratories seeking CPSC acceptance of their accreditation, may be accessed, completed, and submitted online. The applicant must provide, in English, basic identifying information concerning its location, the type of accreditation it is seeking, electronic copies of its certificate and scope statement from an ILAC-MRA signatory accreditation body, and firewalled laboratory training document(s), if relevant.

As explained in the notices of requirements, CPSC staff reviews the submission for accuracy and completeness. In the case of independent and governmental laboratories, when that review and any necessary discussions with the applicant are completed, we will add any accepted laboratory to the CPSC's list of accepted laboratories. This list can be found at:

http://www.cpsc.gov/cgi-bin/labsearch.

In the case of a firewalled laboratory, when CPSC staff's review is complete, CPSC staff transmits its recommendation on acceptance of accreditation to the Commission (meaning, in this instance, the Commissioners) for consideration. If the Commission accepts a CPSC staff recommendation to accept the accreditation of a firewalled laboratory, we will add the firewalled laboratory to the CPSC's list of accepted laboratories. In each case, we notify the laboratory electronically of our acceptance of its accreditation.

The notices of requirements have become effective on publication, meaning that as soon as the notices of

requirements publish, laboratories could apply to the CPSC for acceptance of their accreditation. In most cases, the requirement for a manufacturer or private labeler of a children's product subject to a children's product safety rule to issue a certificate of compliance, based on third party testing with that rule, commences for products manufactured more than 90 days after publication of the notice of requirements that pertains to that rule.

In most cases, the standard or test method specified in a notice of requirements was either already in effect, or became effective upon publication of the notice of requirements. (There were four notices of requirements that published the same day as a final rule establishing the safety standard specified in the notice: the notices of requirements for infant bath seats, infant walkers, cribs, and toddler beds. In those cases, the safety standard took effect six months after publication.

See

75 FR 31688 (June 4, 2010), correction, 75 FR 33683 (June 15, 2010); 75 FR 35282 (June 21, 2010); 75 FR 81789 (Dec. 28, 2010); 76 FR 22030 (Apr. 20, 2011)). Our approach to third party conformity assessment uses and builds upon existing systems of conformity assessment, based on ISO/IEC standards and internationally recognized accreditation bodies. Some manufacturers of children's products subject to children's product safety rules have put in place their own processes for third party testing to demonstrate conformity with certain mandatory and voluntary safety standards. As we were publishing the notices of requirements, we were aware that some manufacturers may already have been testing their products at laboratories that were accredited by an ILAC-MRA signatory accreditation body in accordance with ISO/IEC 17025:2005. Thus, it was possible that when a particular notice of requirements published, some products in the marketplace had already undergone testing (

i.e.,

earlier than the mandatory effective date of third party testing) in a way that would support certification with the respective children's product safety rule(s). Therefore, most notices of requirements included provisions allowing Children's Product Certificates to be based on testing performed by a ISO/IEC 17025:2005-accredited laboratory prior to the CPSC's acceptance of its accreditation. This practice is sometimes referred to as allowing “retrospective” testing. In the notices of requirements, we prescribed particular circumstances under which retrospective testing could support a Children's Product Certificate. For example, we required that the product be tested by a laboratory that was, at the time of product testing, accredited to ISO/IEC 17025:2005 by an ILAC-MRA signatory; the accreditation scope in effect at the time of testing had to include testing to the regulation or test method identified in the notice; and we placed constraints on how far back in time the retrospective testing could have occurred. In several of the initial notices of requirements, we did not allow any retrospective testing by firewalled laboratories. Later, we allowed retrospective testing by firewalled laboratories if the firewalled laboratory had already been accepted by an order of the Commission for testing to a children's product safety rule specified in an earlier notice of requirements.

III. Comments on the Notices of Requirements and the Commission's Responses

The Commission has established requirements for accreditation of third party conformity assessment bodies (“laboratories”) for certain children's product safety rules in accordance with section 102(a)(2) of the CPSIA. Most notices of requirements provided an opportunity for public comment. Below, we describe and respond to the comments submitted in response to the notices of requirements that published before August 14, 2011. As of August 14, 2011, 17 notices of requirements have been published in the

Federal Register

. Table 1 lists the notices of requirements.

Table 1—Notices of Requirements Issued With Comments Received

Regulation or product(s)

Federal Register

citation

Regulations.gov

docket No.

Part 1303/Lead Paint

73 FR 54564, (September 22, 2008) (Revision notice at 76 FR 18645 (April 5, 2011))

CPSC-2008-0033.

Parts 1508, 1509, 1511/Full-size cribs, non-full-size cribs, and pacifiers

73 FR 62965, (October 22, 2008)

CPSC-2008-0038.

Part 1501/Small parts

73 FR 67838, (November 17, 2008)

CPSC-2008-0050.

Lead content in children's metal jewelry

73 FR 78331 (December 22, 2008)

CPSC-2008-0049.

Parts 1203,1510, 1512, 1513, sec. 1500.86(a)(7) and (a)(8)/Bicycle helmets, dive sticks, rattles, bicycles, and bunk beds

74 FR 45428, (September 2, 2009)

CPSC-2009-0067.

Total lead in children's (metal and non-metal) products

74 FR 55820, (October 29, 2009)

CPSC-2009-0090

Part 1505, sec. 1500.86(a)(5)Electrically operated toys/articles and clacker balls

75 FR 22746, (April 30, 2009)

CPSC-2010-0035

Part 1215/Infant bath seats

75 FR 31688, (June 4, 1020), (Correction notice at 75 FR 33683 (June 15, 2010))

CPSC-2010-0064.

Part 1216/Infant walkers

75 FR 35282, (June 21, 2010)

CPSC-2010-0066.

Part 1611/Vinyl plastic film

75 FR 42311 (July 21, 2010)

CPSC-2010-0079.

Parts 1630 and 1631/Carpets and rugs

75 FR 42315 (July 21, 2010)

CPSC-2010-0078.

Part 1610/Clothing Textiles

75 FR 51016 (August 18, 2010) (Revision notice at 76 FR 22608 (April 22, 2011)

CPSC-2010-0086.

Parts 1632 & 1633/Mattresses, Mattress Pads, and Mattress Sets

75 FR 51020 (August 18, 2010)Revision notice at 75 FR 72944 (November 29, 2010)

CPSC-2010-0085.

Part 1420/ATVs

1

75 FR 52616 (August 27, 2010) (Extension notice at 75 FR 76708 (December 9, 2010)

CPSC-2010-0090.

Parts 1615 and 1616/Children's Sleepwear

75 FR 70911 (November 19, 2010)

None.

Parts 1219 and 1220/Full-Size Baby Cribs and Non-Full-Size Baby Cribs

75 FR 81789 (December 28, 2010)

CPSC-2009-0064.

Part 1217/Toddler Beds

76 FR 22030 (April 20, 2011)

CPSC-2009-0064.

ASTM F 963-08, and section 4.27 of ASTM F 963-07 for toy chests (CPSIA Section 106)

76 FR 46598 (August 3, 2011)

CPSC-2011-0050.

CPSC-CH-C1001-09.3

76 FR 49286 (August 10, 2011)

CPSC-2011-0052.

1

We note that recently we published a final rule in the

Federal Register

, revising 16 CFR part 1420. The final rule makes American National Standard, ANSI/SVIA-1-2010, the new mandatory standard for ATVs. Consequently, proposed § 1112.15(b)(9) would refer to the ANSI/SVIA-1-2010 safety standard for all-terrain vehicles for purposes of our acceptance of laboratory accreditation.

A summary of each of the commenters' topics is presented, and each topic is followed by our response. For ease of reading, each comment will be prefaced by a numbered “Comment”; and each response will be prefaced by a corresponding numbered “Response.” Each “Comment” is numbered to help distinguish between different topics. The number assigned to each comment is for organizational purposes only, and does not signify the comment's value, or importance, or the order in which it was received. Comments on similar topics are grouped together.

A. Comments on Baseline Accreditation Requirements

(

Comment 1

)—Some commenters supported the use of International Standards Organization/International Electrotechnical Commission (ISO/IEC) 17025:2005 standard on testing and calibration laboratories and the International Laboratory Accreditation Cooperation—Mutual Recognition Arrangement (ILAC-MRA) because this helps establish an internationally recognized consortium for organizations qualified to provide accreditation services. A commenter recommended that the CPSC conduct periodic reviews and revise the accreditation requirements to ensure that the highest standards for laboratory accreditation are being followed. The commenter suggested that if ISO/IEC 17025:2005 is superseded by a more stringent standard, then the CPSC should adopt the more stringent standard.

(

Response 1

)—Section 14(a)(3)(D) of the CPSA states: “[t]he Commission shall periodically review and revise the accreditation requirements established under subparagraph (B) to ensure that the requirements assure the highest conformity assessment body quality that is feasible.” If a new version of ISO/IEC 17025:2005 is adopted by the ISO, the CPSC will review the new requirements and determine whether the new version would improve the CPSC's laboratory program. Any change to the requirements for CPSC-accepted third party conformity assessment bodies will be pursued as an amendment to 16 CFR part 1112.

(

Comment 2

)—Multiple commenters suggested that the Commission consider accepting laboratory accreditation from the National Environmental Laboratory Accreditation Conference (NELAC). A commenter noted that NELAC follows the ISO/IEC 17025:2005 standard and is similar to the American Association of Laboratory Accreditation (A2LA), an ILAC-MRA signatory accreditation body. The National Environmental Laboratory Accreditation Program (NELAP) implements the NELAC standards.

Another commenter recommended that the CPSC accept the accreditation of laboratories accredited by the American Industrial Hygiene Association (AIHA), which is accredited to ISO/IEC 17011:2004, but was not an ILAC-MRA signatory (at the time the comment was submitted). The AIHA accredits laboratories to ISO/IEC 17025:2005 for the National Lead Laboratory Accreditation Program (NLLAP), administered by the U.S. Environmental Protection Agency (EPA). One commenter stated that, by not including AIHA-accredited laboratories, there are not a sufficient number of laboratories in the United States to handle the volume of testing required by the CPSIA. Multiple commenters recommended that accreditation bodies that are part of the National Cooperation for Laboratory Accreditation (NACLA) be recognized by the CPSC, and thus, enable the laboratories accredited by NACLA members to provide test results for lead in paint that can be used as a basis of issuing a Children's Product Certificate. The NACLA does not rely on mutual recognition among accreditation bodies, but it has a Recognition Council to recognize accreditation bodies. NACLA members follow the provisions of ISO/IEC 17011:2004 and accredit laboratories to ISO/IEC 17025:2005.

(

Response 2

)—In September 2010, AIHA became an ILAC-MRA signatory. Laboratories accredited by AIHA, after becoming an ILAC-MRA signatory, may apply for CPSC acceptance of their accreditation. Therefore, the comment that the Commission should make AIHA a CPSC-designated accreditation body is moot. Currently, NACLA and NELAC are not signatories to the ILAC-MRA. NACLA and NELAC are domestic organizations that do not have recognition arrangements with foreign countries.

The CPSA, as amended by the CPSIA, directs the CPSC to establish and publish notices of requirements for accreditation of third party conformity assessment bodies to assess conformity with a children's product safety rule to which such children's product is subject. The CPSA provides that accreditation of third party laboratories may be conducted by the Commission or by an independent accreditation organization designated by the Commission.

In consideration of the timelines established by the CPSA and the fact that children's consumer products are manufactured for the U.S. market in nations throughout the world, we identified several objectives for a laboratory accreditation program that could accomplish the implementation of the CPSA. These objectives were:

(1) Designate the core elements of a CPSC accreditation program to an entity that is established and has acceptance on a multinational level. The entity should follow internationally recognized standards for assessing the competence of laboratories and for the processes and standards used by accreditation bodies that evaluate such laboratories;

(2) Designate one entity that immediately could bring on board, on a multinational level, the largest number of accreditation bodies that could begin the process of accrediting laboratories in accordance with the CPSC specific requirements for a children's product safety rule; and

(3) Avoid designation to accreditation programs or entities that are recognized only in a specific region, nation, or locality. The reasons for this objective are to: (a) Keep the program as simple as possible for use by manufacturers, private labelers, importers, laboratories, and other interested parties; (b) avoid any perceived notions of barriers to fair trade practices; (c) establish a program that is manageable within agency resources; and (d) maintain a degree of

consistency in the procedures used by the designated accreditation bodies.

The Commission will continue to designate accreditation bodies that are signatories to the ILAC-MRA. We believe that the laboratory accreditation requirements approved by the Commission are consistent with the direction of the CPSA and meet the objectives outlined above.

We recognize that there are other laboratory accreditation organizations or accreditation bodies. Some of these organizations may adhere to similar procedures and standards (but with some distinctions) as those established in the ILAC-MRA signatory program. However, expanding CPSC designations to such organizations would not meet all of the objectives outlined above.

Regarding laboratory testing capacity for lead in paint, we are not aware of any evidence indicating that insufficient CPSC-accepted laboratory testing capacity for lead in paint exists. If lead in paint testing capacity becomes an issue in the future, the CPSC will address the situation.

(

Comment 3

)—A commenter recommended that laboratories “be specifically CPSC accepted based on accreditation which the [ILAC-MRA] system, on its own, may not ensure.” The commenter stated that this would secure the impartiality of certification better. The commenter opposed limiting accreditation bodies to ILAC-MRA signatories because there is no reciprocity with ILAC-MRA countries to accept accreditations from the Occupational Safety and Health Administration (OSHA), the American National Standards Institute, or the Standards Council of Canada.

(

Response 3

)—With regard to the commenter's suggestion that there are standards or norms which the ILAC-MRA system “on its own, may not ensure,” the commenter did not specify what the ILAC-MRA system fails to ensure. Accordingly, we are unable to respond meaningfully to that portion of the comment. As for the impartiality of certification, we note that the CPSA does not require conformity assessment bodies to issue certificates. Instead, section 14(a)(2) of the CPSA assigns responsibility for certifying to “every manufacturer of [a children's product subject to a children's product safety rule] (and the private labeler of such children's product if such children's product bears a private label).”

The topic of reciprocity is addressed in the response to Comment 7.

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Comment 4

)—A commenter responding to the notice of requirements for accreditation of laboratories to assess conformity with 16 CFR part 1505 (electrically operated toys or other electrically operated articles intended for use by children) stated that many requirements of the regulation would not be evaluated by laboratory testing, but rather, would be evaluated via inspection, auditing, and construction review. For example, the fulfillment of requirements in §§ 1505.3, pertaining to labeling, 1505.4, regarding manufacturing requirements, and 1505.5, related to electrical design and performance, generally would not be evaluated by what is commonly understood as “laboratory testing.” The commenter suggested using ISO/IEC 17020:1998,

General criteria for the operation of various types of bodies performing inspection,

as the accreditation requirements for these activities. The commenter said that the CPSC could supplement ISO/IEC 17020:1998 criteria with additional specific requirements for individuals performing these activities to ensure that individuals possess engineering education, training, and experience to evaluate compliance effectively.

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Response 4

)—Section 14(a)(2) of the CPSA requires manufacturers of any children's product subject to a children's product safety rule to submit the product for third party testing. As structured by the CPSA, certification of compliance with children's product safety rules is based on product testing (not manufacturing facility inspection) at a third party conformity assessment body (laboratory). A third party conformity assessment body conducts all of the performance tests in the standard. The portions of the standard, rule, ban, or regulation that do not use testing are attested to by the manufacturer when it issues a Children's' Product Certificate for the product.

Inspection, as intended by ISO/IEC 17020:1998, is generally used for individual items or very small production volumes. Conformity assessment is used for assuring compliance to established standards and is applicable to larger production volumes. At this time, we decline to recommend adopting the suggestion of using ISO/IEC 17020:1998.

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Comment 5

)—One commenter urged the Commission to consider third party certification of products (as opposed to third party testing) by certification bodies accredited to ISO/IEC 17065,

General Requirements for Bodies Operating Product Certification Systems.

The commenter stated that third party certification includes actions taken by the certifying body to ensure continuing conformance. The commenter suggested that requiring third party certification and marking would be less costly and more effective. The commenter urged the CPSC to consider the principles of product certification outlined in the American National Standards Institute (ANSI) document,

National Conformity Assessment Principles for the United States.

Another commenter asked that the CPSC consider alternative criteria for accreditation to allow for organizations that are accredited to Standard ISO/IEC 17065.

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Response 5

)—With regard to the suggestion that the Commission consider third party certification of products, section 14(a)(2) of the CPSA specifically states that samples of the children's product are submitted to a third party conformity assessment body for testing (not for certification), and that the manufacturer or private labeler of the children's product issue the certificate that certifies that the product complies with the applicable children's product safety rules. That responsibility cannot be delegated to another party. Thus, certification of a children's product by a third party certification body does not meet the requirements of the CPSA.

With regard to the commenter's suggestion that the CPSC consider including alternative criteria for accreditation to allow CPSC acceptance of accreditations to ISO/IEC 17065, ISO/IEC 17065 has not (as of the date of this proposed rule) been finalized. This draft standard is still in development as a revision to ISO Guide 65:1996,

General Requirements for Bodies Operating Product Certification Systems.

Because ISO/IEC 17065 has not been finalized, we cannot evaluate whether this standard would meet the requirements of the CPSA. If we assume that the provisions of ISO Guide 65:1996 are maintained in ISO/IEC 17065, § 1.2 of ISO Guide 65:1996 states that the certification system used by the certification body may include one of more of a list of evaluation techniques. Included in that list are methods that do not involve testing for compliance to the applicable children's product safety rules. Section 14(a)(2)(B) of the CPSA requires Children's Product Certificates to be based on testing. Because ISO Guide 65:1996 allows for product certification without testing, certification by organizations that are accredited to ISO Guide 65:1996 may not include the required testing and cannot be used for children's product certification purposes.

With regard to the ANSI document,

National Conformity Assessment Principles for the United States,

this

document mirrors many widely-accepted concepts and processes used by conformity assessment bodies and certification bodies. For example, provisions in the ANSI document regarding testing competency and protection of a customer's data are mirrored in ISO/IEC 17025:2005 and ISO Guide 65:1996. However, the principles in the ANSI document are more closely related to product certification, and thus, are not appropriate for laboratories involved in support of children's product certification by the manufacturer. For example, conformity assessment principle number 12 in the ANSI document states: “As appropriate, conformity assessment bodies undertake reasonable surveillance procedures to ensure continued product conformity and protection of their mark.” Surveillance procedures and certification marks are activities typically undertaken by certification bodies, not laboratories conducting tests. Thus, we decline to recommend adopting the suggestion of using the ANSI document because it relates to certification activities not undertaken by testing.

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Comment 6

)—Some commenters supported the use of ISO/IEC 17025:2005 as an accreditation tool but emphasized the importance of ensuring that the scope of accreditation applies only to the testing for which the conformity assessment body has demonstrated competence.

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Response 6

)—We agree with the commenters. Every conformity assessment body applying for CPSC acceptance of their accreditation must submit a statement of scope that lists explicitly the CPSC regulation(s) and/or test method(s) for which they are applying.

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Comment 7

)—Multiple commenters suggested adopting reciprocity provisions as a part of laboratory accreditation requirements. Reciprocity, in this context, means that if the CPSC accepts the accreditation of foreign laboratories to test consumer products for compliance to the requirements of section 14 of the CPSA, the host country of the foreign laboratory must provide similar treatment to U.S.-based laboratories. Possible reciprocity provisions could include a statement that, in reviewing a laboratory's application, the CPSC will take into consideration whether the host country of the applicant provides similar accreditation for U.S.-based laboratories in their markets. Another possible reciprocity policy would require that the countries of non-U.S.-based laboratories that wish for their accreditation to be accepted by the CPSC, offer recognition to U.S-based laboratories for that country's certification programs.

One commenter stated that a reciprocity provision would benefit U.S. manufacturers because reciprocity would allow for streamlined testing requirements and protocols across international markets and would also keep manufacturers from sending testing samples to multiple testing facilities around the world in order to “shop” for passing testing results. Another commenter stated that without reciprocity provisions, U.S.-based laboratories are damaged by not having access to other countries' conformity assessment systems. The commenter recommended that the CPSC amend its proposed accreditation requirements to include reciprocity provisions identical to those used by OSHA under its Nationally Recognized Testing Laboratory (NRTL) program.

One commenter stated that, without reciprocity provisions, the product safety scheme will lack the necessary shared interest in quality oversight to make it a functioning program.

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Response 7

)—We decline to adopt reciprocity as a criterion in the CPSC third party conformity assessment body program, although we are aware that the other federal laboratory recognition programs contain such a provision. At this time, we have not determined that reciprocity promotes consumer safety. The mission of this agency is to protect the public against unreasonable risks of injury from consumer products. One way we accomplish that mission is by implementing the CPSIA's requirement that products subject to children's product safety rules be third party tested. Thus, our interest, in this instance, is to establish an effective and efficient laboratory program through which we recognize laboratories that are competent to conduct these third party tests.

As for the comment regarding shared interest in quality oversight, to the extent that the commenter is suggesting that reciprocity provisions are necessary for the CPSC's laboratory program to function, the commenter did not describe how or why having reciprocal testing-body recognition is necessary to implementing section 14 of the CPSA. We use accreditation by an ILAC-MRA signatory accreditation body to an international standard, ISO/IEC 17025:2005, and additional information, to determine whether to accept the accreditation of an applicant laboratory. Sections 1.4 and 1.6 of ISO/IEC 17025:2005 specifically refer to the quality management system of the laboratory. Laboratories accredited to ISO/IEC 17025:2005 must implement a quality management system, appoint a staff member as quality manager, and continually improve the effectiveness of its management system through the use of quality policy, quality objectives, audit results, and other factors. None of these quality oversight items requires reciprocity between nations.

B. Comments on Firewalled/Governmental Laboratories and Undue Influence

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Comment 8

)—One commenter stated the belief that validation of a laboratory's independence is critical to the success of all CPSC safety initiatives, including program development for third party testing of children's products. The commenter pointed to OSHA's NRTL program and ISO Guide 65:1996 as a means to underscore the critical role of independence. ISO Guide 65:1996 details the requirements of operating without a conflict of interest and includes several requirements concerning organizational structure to protect impartiality and to prevent conflict of interest. The commenter suggested that the Commission should consider the requirements of Clause 4.2 of ISO Guide 65:1996 and look to OSHA's NRTL program as an example of the level of inquiry that should be required, the type of requirements that should be implemented, and to ensure impartiality and prevent conflict of interest.

The commenter noted that these issues deserve special emphasis for proprietary (firewalled) and governmental laboratories. Under the CPSC's laboratory accreditation requirements that were published in the notices of requirements and that are provided in additional detail in this proposed rulemaking, firewalled and governmental laboratories are required to demonstrate particular undue influence safeguards, as specified in the CPSA, in addition to the requirements of the ISO/IEC 17025:2005 standard.

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Response 8

)—The OSHA program and ISO Guide 65:1996 are tailored to certification bodies/programs and not to laboratories that conduct tests. Under the structure of third party testing required by the CPSA (as amended by the CPSIA), product certification elements (certifying compliance with a CPSC rule) are the responsibility of the manufacturer or private labeler. The certifying manufacturer or private labeler must support its certificate of compliance with testing by a CPSC-accepted laboratory (referred to in the CPSA as third party conformity

assessment body). There are international standards written specifically for different areas related to conformity assessment (

e.g.,

inspection activities, certification programs, laboratories). Because the CPSA requires the CPSC to establish requirements for entities that conduct product testing, the CPSC programs require the ISO/IEC standard that is specifically applicable to testing laboratories (ISO/IEC 17025:2005). ISO/IEC 17025:2005 has provisions that require the laboratory to have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment, or operational integrity. A third party laboratory must demonstrate that it is impartial and that its personnel are free from any undue commercial, financial, and other pressures that might influence their technical judgment. ILAC-MRA signatory accreditation bodies assess laboratories to these criteria during laboratory assessments.

In addition, the CPSA requires that firewalled and governmental laboratories satisfy certain criteria, which include protections against undue influence. The CPSC implements those criteria, such that firewalled and governmental laboratory applicants must submit additional materials that address undue influence safeguards. For a full description of the additional application materials, see discussion of proposed § 1112.13(b) and (c) in section IV, B.2 of the preamble.

The criteria for safeguards against undue influence are addressed by the proposed CPSC requirements, and there should not be additional criteria based on programs or standards that are not specific for laboratories that conduct tests.

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Comment 9

)—One commenter urged the CPSC to “differentiate between what are authentic, third party conformity assessment bodies from manufacturer-owned, firewalled labs.” The commenter stated that such differentiation would be consistent with widely used terminology in the manufacturing communities and would reflect the structure of the laboratories better.

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Response 9

)—We interpret the commenter as addressing our use of the term “third party conformity assessment body” to refer to any of the three types of laboratories accepted by the CPSC (independent, firewalled, and governmental). To many in the consumer product industry, a “third party conformity assessment body” corresponds only to an independent laboratory.

Section 14(f) of the CPSA defines and discusses the term “third party conformity assessment body” to include all three types of laboratories. Accordingly, the notices of requirements, and this proposed rule, describe all laboratories whose accreditation has been accepted by the Commission as “third party conformity assessment bodies,” whether they are independent, governmental, or firewalled.

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Comment 10

)—The notices of the requirements for accreditation of third party conformity assessment bodies require firewalled laboratory applicants to submit copies of training documents showing how employees are trained to notify the CPSC 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. Some commenters suggested that the Commission develop standards for these training documents. A commenter noted that standards for impartiality are addressed in ISO Guide 65:1996, which, as a starting place, could be used for this purpose. A commenter also suggested that the CPSC, in developing standards for training documents, consider other standards or best practices that are protective of laboratory and test result integrity.

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Response 10

)—The CPSA includes a provision that requires all CPSC-accepted firewalled laboratories to establish procedures to ensure that employees may report immediately and confidentially allegations of undue influence to the CPSC, 15 U.S.C. 2063(f)(2)(D). The notices of requirements have required firewalled laboratory applicants to submit copies, in English, of their training documents showing how employees are trained on those procedures. This proposed rule would continue that requirement.

A team of CPSC staff reviews applications from firewalled laboratories, including the submission of training documents. If the team concludes that the application materials satisfy the statutory requirements for acceptance as a firewalled conformity assessment body, the team recommends the applicant for Commission acceptance. Thus far, the training documents submitted by firewalled laboratory applicants have indicated clearly whether section 14(f)(2)(D) of the CPSA has been satisfied. However, the CPSC will consider this suggestion as we review future applications from firewalled laboratories. Should we determine that establishing standards for training documents would be helpful, we will consider the criteria for impartiality in other standards and best practices.

We note that accreditation bodies play a role in ensuring impartiality of firewalled laboratories as well. Section 4.1.5(b) of ISO/IEC 17025:2005 requires that the laboratory “have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work.” Note 2 under § 4 of ISO/IEC 17025:2005,

Management Requirements,

states:

If the laboratory wishes to be recognized as a third party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgment. The third party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing or calibration activities.

The accreditation body evaluates the laboratory regarding this provision during the initial assessment and during each reassessment. Thus, the firewalled laboratory's accreditation body also evaluates the policies and procedures by which the laboratory avoids activities that would diminish confidence in its impartiality.

To the extent that these commenters also intended to suggest that the CPSC apply standards to the training documents submitted by government laboratory applicants, we note that, to date, the CPSC has not requested that governmental laboratory applicants submit training documents. Nor are we proposing in this rule that governmental laboratory applicants submit training documents to the CPSC. Sections 14(f)(2)(D)(ii)(II) and (III) of the CPSA specifically require that applicants for firewalled status have established procedures to ensure that,

inter alia,

the CPSC is notified immediately of any attempt at undue influence and that allegations of undue influence may be reported to the CPSC confidentially. To implement those provisions, we require firewalled applicants to submit training documents so that we can ensure that these safeguards have been communicated to employees. The statute does not require governmental laboratories to have established policies that involve employees notifying the CPSC immediately and confidentially of an attempt at undue influence. Thus, we are not requiring training documents from governmental laboratory

applicants in support of such requirements. Instead, the CPSIA established five criteria that each governmental applicant must satisfy to have its accreditation accepted by the CPSC. To implement those criteria, the proposed rule would require a governmental laboratory applicant to submit responses to a questionnaire, a description of its relationship with other entities, an attestation, and the laboratory's undue influence policy. For more information on those requirements, see the discussion of proposed § 1112.13(c) in section IV.B.2 of the preamble.

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Comment 11

)—Some commenters recommended that the Commission establish safeguards to ensure that employees who are engaged in conformity assessment activities are not rewarded for positive outcomes of testing.

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Response 11

)—We agree that a third party conformity assessment body should not reward an employee for a “passing” test result. The notices of requirements have required, and this proposed rule would continue requiring, that CPSC-accepted laboratories be accredited to the provisions in ISO/IEC 17025:2005 by a signatory to the ILAC-MRA. Section 4.1.5(b) of ISO/IEC 17025:2005 states that the laboratory shall “have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial, and other pressures and influences that may adversely affect the quality of their work.” The laboratory's accreditation body checks for conformance to this section of ISO/IEC 17025:2005 during initial accreditation and each reassessment. Therefore, we consider the commenters' suggestion to be addressed already in the ISO/IEC 17025:2005 requirements, and therefore, additional CPSC requirements are not warranted.

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Comment 12

)—One commenter, who responded to several notices of requirements, suggested that we require applicants, including the firewalled and governmental laboratories, to submit the evidence used to validate the fulfillment of § 4.1.5(b) of ISO/IEC 17025:2005, as part of their application to the CPSC to assure impartiality and avoid undue influence. The commenter argued that this information is particularly necessary because the requirements for firewalled laboratories to submit documents related to staff training on undue influence “are not sufficient on their own to pro-actively assure the Commission about the impartiality of a firewalled (or government) laboratory.” The commenter contended that requiring evidence of the fulfillment of § 4.1.5(b) of ISO/IEC 17025:2005 would drive accreditation bodies and laboratories to pay more specific attention to ISO/IEC 17025:2005 § 4.1.5(b); promote consistency; and provide the CPSC with a means of monitoring compliance.

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Response 12

)—We believe that requiring applicants to submit records used to validate the fulfillment of § 4.1.5(b) of ISO/IEC 17025:2005 to the CPSC is unnecessary. It is the role of the laboratory's accreditation body to evaluate whether a laboratory satisfies the requirements of ISO/IEC 17025:2005; it would be duplicative for the CPSC to perform the same evaluation. Accreditation bodies have the expertise to evaluate laboratories to all provisions of ISO/IEC 17025:2005, including § 4.1.5(b).

With regard to the suggestion that, if the CPSC required submission of the evidence of compliance with § 4.1.5(b) of ISO/IEC 17025:2005, accreditation bodies and laboratories would pay more specific attention to that requirement, we believe that accreditation bodies garner significant attention from laboratories. If a laboratory failed to meet the requirements of ISO/IEC 17025:2005 to the satisfaction of its accreditation body, the laboratory could lose its accreditation and a potentially significant portion of its business.

With regard to the suggestion that submission of the records used to validate fulfillment of ISO/IEC 17025:2005 § 4.1.5(b) would promote consistency among laboratories, we respond that currently, we do not perceive any need to do so. The Commission has decided to designate laboratory accreditation to ILAC-MRA signatories, per section 14(a)(3)(C) of the CPSA. At this time, we are not aware that this designation has resulted in problems regarding undue influence. Requiring submission of the records used to validate the fulfillment of ISO/IEC § 4.1.5(b) would impose a burden on the CPSC and laboratories, without corresponding benefit. Finally, we note that fulfillment of the requirements of ISO/IEC 17025:2005 § 4.1.5(b) may be achieved in a number of ways. Decreasing variability in how laboratories fulfill that requirement would not necessarily increase protection against undue influence.

With regard to the suggestion that the submission of records used to validate fulfillment of ISO/IEC 17025:2005 § 4.1.5(b) would promote consistency among accreditation bodies, the ILAC-MRA evaluation process of an accreditation body involves a team of peer review members drawn from multiple accreditation bodies located around the world. This multi-member team arrangement tends to harmonize how the requirements of § 4.1.5(b) of ISO/IEC 17025:2005 are fulfilled around a common set of principles shared by the globally distributed team members.

With regard to the suggestion that requiring the submission of evidence of the fulfillment of ISO/IEC 17025:2005 § 4.1.5(b) to the CPSC would provide us with a means of monitoring compliance, we do not agree. Records related to accreditation assessments and reassessments are maintained by the accreditation bodies and the laboratories. The final rule on the audit requirements (implementing § 14(i)(1) of the CPSA) requires a third party conformity assessment body to retain records relating to the last three reassessments conducted by the accreditation body and make such records available to the CPSC upon request. Records of nonconformities related to safeguards against undue influence (or any ISO/IEC 17025:2005 requirement) and the corrective actions must be made available to the CPSC upon request. Accordingly, we already have a means of monitoring compliance with this and every other provision in ISO/IEC 17025:2005.

With regard to the commenter's particular concern with firewalled and governmental laboratories, CPSC acceptance of these types of laboratories requires the submission and evaluation of additional information specifically dealing with avoiding undue influence. Proposed § 1112.13(b) and (c) provide details of the additional documentation we would require for CPSC acceptance of the accreditation of firewalled and governmental laboratories.

The proposed rule would require these additional application materials from firewalled and government laboratories because we expect that they will provide us with helpful information concerning the structure and independence of these applicants.

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Comment 13

)—Another commenter similarly pointed out that independent laboratories can “easily” satisfy ISO/IEC 17025:2005 § 4.1.5(b) but stated that the application of this requirement to firewalled and governmental laboratories “poses issues of commercial, financial, and political pressures.” The commenter suggested that the CPSC impose “additional audit requirements and accreditation decisions” on firewalled and government laboratories, and that the CPSC require from such applicants “additional application information * * * which should include, but not be

limited to, extensive public disclosure of both manufacturer and/or government laboratory personnel involved in the testing of the relevant product(s).”

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Response 13

)—The commenter did not specify what additional audit requirements or accreditation decisions it thought the CPSC should impose. However, with regard to this commenter's recommendation that the CPSC require additional application materials from firewalled and governmental applicants, as explained in the response to Comment 10, the proposed rule would require such materials.

We decline the suggestion to require extensive public disclosure of manufacturer and/or government laboratory personnel. We consider that mandating such disclosure would constitute an invasion of personal privacy that would be unwarranted when balanced against the public interest in the information.

See Horowitz

v.

Peace Corps,

428 F.3d 271 (DC Cir. 2005) (“we must balance the private interest involved [namely, `the individual's right of privacy'] against the public interest”).

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Comment 14

)—Some commenters suggested that the sampling frequency of firewalled laboratories should be double that of independent conformity assessment bodies. Although it was not clear from the submissions, these commenters may have been suggesting that the government laboratories also test twice as many samples as independent laboratories.

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Response 14

)—Section 14(a)(2) of the CPSA requires that a manufacturer of a children's product subject to a children's product safety rule submit “sufficient samples of the children's product, or samples that are identical in all material respects to the product,” to a third party conformity assessment body for testing. Under the requirement of the statute, then, it is the manufacturer, as opposed to the laboratory, who determines what sample is provided to the laboratory for testing, and the agency has no authority to transfer responsibility for determining sample size to the laboratories. The CPSC has addressed the sufficiency of the number of samples required under section 14(a)(2) of the CPSA in the final rule,

Testing and Labeling Pertaining to Product Certification.

76 FR 69482 (November 8, 2011).

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Comment 15

)—Some commenters also suggested that firewalled laboratories be required to meet additional requirements, such as:

• Public disclosure that the manufacturer has a financial interest or ownership stake in the laboratory;

• Submission of materials that identify whether employee compensation or annual bonuses (including stock options) are tied to the financial performance of the controlling manufacturer;

• Submission of detailed protocols by which the engineering staff of the firewalled laboratory do not either transfer from or transfer to the manufacturer's staff, or otherwise look to the manufacturer for career advancement; and

• Evidence that employees are required to participate, and regularly pass, third party ethics and compliance audits and programs intended to detect and protect against undue influence. The International Federation of Inspection Agencies (IFIA) Compliance Code was mentioned as a possible standard. Employees should also be required to submit to any programs established by the manufacturer/firewalled laboratory, including training, reporting, monitoring, investigating, and enforcement, intended to protect against and detect undue influence.

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Response 15

)—With regard to the suggestion that the CPSC require firewalled laboratories to publicly disclose that the manufacturer has a financial interest or ownership stake in the laboratory, section 14(f)(2)(D) of the CPSA provides that a firewalled laboratory may be accepted by the Commission only if the Commission, by order, makes certain findings concerning the firewalled laboratory. The orders of the Commission accepting the accreditation of firewalled laboratories are public and are posted on the CPSC's Web site. Accordingly, there is public disclosure of each firewalled laboratory applicant at the time the Commission votes on whether to accept the firewalled laboratory's accreditation. (

See, e.g.,

http://www.cpsc.gov/library/foia/foia10/brief/firewalled.pdf)

.

With regard to the suggestions that firewalled laboratories be required to identify whether employee compensation or annual bonuses (including stock options) are tied to the financial performance of the controlling manufacturer, and that the CPSC require submission of detailed protocols by which the engineering staff of the firewalled laboratory do not either transfer from or transfer to the manufacturer's staff or otherwise look to the manufacturer for career advancement, we do not believe that such information would be dispositive. The core concern is whether the testing process will be tainted, and this concern drives the provisions that were in the notices of requirements, as well as the provisions in this proposed rule, which seek to ensure that the testing process is protected against undue influence. As explained in the response to Comment 16, we are proposing to expand the definition of “firewalled laboratory,” and we are requiring more information from those entities about safeguards against undue influence.

As we have noted in the responses to Comments 10 and 11, § 4.1.5(b) of ISO/IEC 17025:2005 requires that the laboratory have arrangements to ensure that it is free from undue influence. The accreditation body evaluates the laboratory's fulfillment of this provision at the initial accreditation and at each reassessment. Further, section 14(f)(2)(D)(ii) of the CPSA requires the Commission, by order, to find that the conformity assessment body has established procedures to ensure that its test results are protected from undue influence by the manufacturer, private labeler, or other interested party. Because multiple entities are evaluating the means by which the firewalled laboratory avoids undue influence by the manufacturer, additional application requirements for firewalled applicants are not seen as necessary at this time. At a future date, we may consider additional requirements for firewalled laboratories in response to evidence that the prevailing requirements are not effective.

Finally, as for the suggestion that we require evidence that employees are required to participate, and regularly pass, third party ethics and compliance audits and to submit to any programs established by the manufacturer/firewalled laboratory intended to detect and protect against undue influence, we decline to adopt this suggestion. Under the proposed rule, a firewalled laboratory applicant would be required to submit, among other things, copies of training documents, including a description of the training program content), showing how employees are trained to notify the CPSC 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; and training records (including training dates, location, and the name and title of the individual providing the training), listing the staff members who received the required training. At this time, we believe that requiring these training records sufficiently addresses our interest in ensuring that firewalled laboratory personnel are adequately trained in detecting and protecting against undue influence. Again, however, we will continue to consider this suggestion, and if additional requirements concerning undue influence-related training of laboratory

personnel would be helpful, we may recommend adopting additional training requirements in the future.

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Comment 16

)—Other commenters expressed concern about the situation in which a laboratory and a manufacturer are owned by the same parent company. The commenter urged the Commission to expand the definition of “firewalled laboratories” to cover common parentage of laboratories.

The commenter suggested further that the definition of “firewalled laboratories” be extended to include laboratories that do 50 percent or more of their business with a single manufacturer or private labeler of children's products.

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Response 16

)—We agree that if a laboratory and a manufacturer share a common corporate parent, and the laboratory intends to test the manufacturer's children's products for certification purposes, the laboratory should be considered a firewalled laboratory. The proposed rule would address the situation of common parentage in the definition of a “firewalled laboratory.” The proposed rule would have an applicant attest to whether it satisfies any aspect of the definition of a “firewalled laboratory.” One attestation concerns common parentage; the applicant would need to attest to whether it is affiliated with a manufacturer or private labeler of the children's product. “Affiliated with” would mean that the conformity assessment body is in the same ownership network as a manufacturer or private labeler of the children's product, with the exception that “affiliated with” does not include a manufacturer or private labeler of the children's product that is owned, managed or controlled by the conformity assessment body.

We considered the potential controlling effect of manufacturers with a significant part of a laboratory's business, and concluded that evaluating such a factor would be challenging administratively and difficult to verify. Variables such as the time period and types of products to consider could have a significant impact on any calculation of a percentage of a laboratory's business.

However, the proposed rule would address management and/or control of a laboratory by a manufacturer or private labeler by including in the definition of “firewalled laboratory,” laboratories over which a manufacturer or private labeler has the ability to appoint a majority of the laboratory's senior internal governing body; the ability to appoint the presiding official of the laboratory's senior internal governing body; or the ability to hire, dismiss, or set the compensation level of laboratory personnel. Another proposed aspect of this definition would be to deem “firewalled,” a laboratory that is under contract to a manufacturer or private labeler, such that the contract limits explicitly the services that the laboratory may perform for other customers or limits explicitly which or how many other entities may be customers of the laboratory.

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Comment 17

)—A commenter suggested that, as a requirement for accreditation, we consider accrediting only manufacturer-controlled laboratories that agree that their entire organization, including the firewalled laboratories, will be held strictly liable for defective products. For foreign governmental laboratories, the commenter suggested that we require, as a condition of accreditation, that any foreign governmental lab that seeks to test and certify products be required to agree to submit to the jurisdiction of U.S. regulatory agencies and U.S. courts without asserting claims of sovereign immunity or other defenses seeking to limit their liability.

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Response 17

)—We decline to adopt the commenter's suggestions. The statutes enforced by the Commission are structured to assign liability to culpable persons or entities. To the extent that by “entire organization,” the commenter means that the manufacturer owns, manages, or controls the firewalled laboratory, potential liability already exists under the statutes enforced by the Commission. It would be redundant to require the laboratory to agree to such liability as a condition of becoming accepted by the CPSC. To the extent that the commenter intends to suggest that the firewalled laboratory itself be held liable, we do not have the authority to assign liability to an entity that is not already culpable under the law.

With regard to the suggestion that we require foreign governmental laboratories to agree to submit to the jurisdiction of U.S. regulatory agencies and courts without asserting claims of sovereign immunity, or asserting other bases for limiting their liability, such actions are beyond the scope of our laboratory accreditation authority.

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Comment 18

)—One commenter advised the Commission to “consider the liability implications that may arise from accrediting a firewalled or foreign governmental laboratory in the event that one of those laboratories permits an unsafe product [to] enter the U.S. marketplace, as well as the legal remedies thereto.”

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Response 18

)—We interpret the commenter as expressing concern that there may be obstacles to the CPSC holding CPSC-accepted firewalled and foreign governmental laboratories legally accountable for the tests they conduct. Section 14(f) of the CPSA establishes that firewalled and governmental laboratories may be accredited by the Commission to conduct third party tests of children's products. We wish to assure this commenter that we pursue available legal remedies against entities that permit unsafe products to enter the U.S. marketplace. We also note that, under the proposed rule, the Commission would be able to withdraw its acceptance of a laboratory on such grounds as the laboratory failed to comply with the requirements of subpart B of the proposed rule, and/or if the laboratory succumbs to undue influence.

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Comment 19

)—One commenter suggested that we require assessments of a laboratory's independence and freedom from undue influence annually, or at least require that these assessments coincide with other reassessment and surveillance visits.

(

Response 19

)—We agree that a laboratory's independence should be reassessed on a regular basis. The final rule on audit requires that the reassessment portion of an audit, which is conducted by the accreditation body, include an examination of the laboratory's management system to ensure that the laboratory is free from any undue influence.

In addition to a laboratory's reassessment visits, surveillance visits can be conducted by accreditation bodies during the period between reassessments. Surveillance visits are assessments that are conducted for a particular purpose, such as to follow up on a previously observed problem or to ensure that a newly accredited laboratory has implemented necessary procedures. Surveillance visits may or may not be conducted for purposes of reviewing the impartiality of a laboratory, and thus, may or may not involve a reassessment of a laboratory's impartiality.

(

Comment 20

)—A commenter suggested that there is no objective basis for assessing the additional application materials submitted by governmental conformity assessment bodies.

(

Response 20

)—We interpret the commenter's suggestion as urging the Commission to issue objective standards for assessing these applications. Section 14(f)(2) of the CPSA, as amended by section 102 of the CPSIA, establishes five criteria which, in addition to the baseline requirements, a third party conformity assessment body owned or controlled, in whole, or in part, by a

government must satisfy. These criteria are:

(i) 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;

(ii) the entity's testing results are not subject to undue influence by any other person, including another governmental entity;

(iii) the entity is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited under this section;

(iv) the entity's testing results are accorded no greater weight by other governmental authorities than those of other third party conformity assessment bodies accredited under this section; and

(v) the entity 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 entity's conformity assessments.

15 U.S.C. 2063 (f)(2)(B) of the CPSA.

In order for us to evaluate whether a governmental laboratory applicant satisfies the statutory criteria, we have developed a standard questionnaire and requests for documentation that each governmental laboratory applicant is asked to complete. The questionnaire accompanies the proposed rule as part of the CPSC's Paperwork Reduction Act package, and the required documents are described in proposed § 1112.13(c)(2). In addition, CPSC staff reviews governmental laboratory applications using a standardized review document that provides grounds and reasoning for a finding relative to each of the five statutory criteria. These standardizations provide increased objectivity to the application review process, and the questionnaire and documentation requirements are being published via this proposed rule.

(

Comment 21

)—Some commenters that are foreign governments contended that, rather than assess additional application materials before acting on a governmental laboratory application, we should accept each governmental laboratory applicant, unless there is evidence that the applicant fails to satisfy the statutory criteria. The commenters argued that our approach is not fair and is inconsistent with the principal of impartiality expressed in the statutory criterion, which requires that the applicant laboratory “is not accorded more favorable treatment than other third party conformity assessment bodies in the same nation who have been accredited.”

The commenters also argued that our approach violates the “mutual recognition principle of conformity assessment procedures” under the international treaty, “Agreement on Technical Barriers to Trade” (TBT Agreement). The commenters also invoked article 6.3 of the TBT Agreement, which encourages members to negotiate agreements for the mutual recognition of conformity assessments, and the commenters suggested additional consultations on these issues.

One commenter raised several issues under the World Trade Organization's TBT Agreement. The commenter stated that Article 2.4 of the TBT Agreement requires members to use relevant international standards (if they exist) as a basis for their technical regulations and said that ISO 9239-1,

Reaction to fire tests for floorings—Part 1: Determination of the burning behavior using a radiant heat source,

ISO 9239-2,

Reaction to fire tests for floorings—Part 2: Determination of flame spread at a heat flux level of 25 kW/m2,

and ISO 6925,

Textile floor coverings—Burning behavior—Tablet test at ambient temperature,

“contain specifications to fire tests for floorings.” The commenter said that these international standards “would be an effective and appropriate means for the fulfillment of the objective pursued by CPSC.”

Finally, another commenter referred to Article 5.1.2 of the TBT Agreement to state that “conformity assessment procedures shall not be more strict than necessary to give the Importing Member adequate confidence that products conform to the applicable technical regulations or standards.” The commenter also cited Articles 2.4, 2.5, 2.9.3, 5.4, and 5.6.3 of the TBT Agreement and asked us to “identify parts, if any, of the new regulation which in substance deviate from relevant international standards and to explain why such deviation has become necessary.”

(

Response 21

)—To the extent that these commenters are suggesting that our approach has been partial to nongovernmental laboratory applicants, we acknowledge that there are criteria imposed by the CPSIA that apply only to governmental laboratory applicants. We have chosen to determine whether the criteria are satisfied before acting on each application. Similarly, we have not accepted any firewalled laboratory applicant without determining first that it satisfies the statutory criteria relevant to that type of laboratory (

see

section (f)(2)(D) of the CPSA). We have chosen to defer action on governmental and firewalled laboratory applications until we determine that the statutory criteria are satisfied because we want to ensure that CPSC-accepted third party conformity assessment bodies have the structures and practices required by the statute to avoid undue influence, or any other interference with, or compromise to, the integrity of the testing process. This is consistent with the goal of the CPSIA that children's products that enter the U.S. marketplace have been tested by a competent and unbiased laboratory.

We do not agree that this approach is unfair. Because neither governmental nor firewalled laboratories are independent entities, both are potentially subject to undue influence from the organizations to which they are connected, which have interests beyond product testing. The CPSIA imposes additional requirements on firewalled and government laboratories so that only laboratories that are arranged to avoid undue influence sufficient to satisfy the statutory criteria may be accepted. We remain committed to implementing the conformity assessment program established by the CPSIA fairly and with the primary goal of product safety in mind.

The notices of requirements have not contradicted the TBT Agreement. We are willing to accept laboratories recognized by foreign governments if the laboratories satisfy the statutory requirements, including the five statutory criteria listed above (as long as the laboratory satisfies the baseline criteria) in the case of laboratories owned or controlled in whole, or in part, by a government. In fact, we have accepted the accreditations of several governmental laboratories, and we have applied the same statutory criteria to governmental laboratories, regardless of whether the governmental laboratory was located in a foreign country or in the United States. (Indeed, we note that the definition of “government participation” in section 14(f)(2)(B) of the CPSA (for purposes of a “third party conformity assessment body”) is not limited to foreign governments.) The CPSC consults extensively with laboratories seeking to become accepted to test products under section 14 of the CPSA. We remain open to further consultation on these issues with any interested laboratory applicant.

With respect to specific articles in the TBT Agreement, the commenter addressing Article 2.4 of the TBT agreement may have misinterpreted the notice of requirements. The notice of requirements simply establishes the conditions under which the CPSC will accept the accreditation of a third party conformity assessment body to test a children's product for compliance with a particular children's product safety rule. The notice of requirements does

not affect the regulations pertaining to the children's product itself.

Similarly, the commenter addressing Article 5.1.2 of the TBT agreement may have misinterpreted the notice of requirements. This commenter was responding to the notice of requirements pertaining to 16 CFR part 1630,

Standard for the Surface Flammability of Carpets and Rugs (FF 1-70)

and/or part 1631,

Standard for the Surface Flammability of Small Carpets and Rugs (FF 2-70)

(See 75 FR 42315 (July 21, 1010)). The notice of requirements for 16 CFR parts 1630 and/or 1631, however, did not affect or alter the standards established or test methods required in 16 CFR parts 1630 and/or 1631. It simply informed laboratories of the process and requirements by which they could apply to test children's products according to the test method detailed in parts 1630 and/or 1631. A laboratory that has been ISO/IEC 17025:2005-accredited by an ILAC-MRA signatory to conduct flammability tests for floor coverings pursuant to a standard other than 16 CFR parts 1630 and/or 1631 that has similar test methods would likely not find it difficult to expand its accreditation scope with its accreditation body to include 16 CFR parts 1630 and/or 1631 and subsequently apply to the CPSC to test children's products subject to these regulations.

Moreover, consistent with Article 5.1.2 of the TBT Agreement, the notices of requirements have not established procedures and requirements for laboratories that are more strict than necessary to give the CPSC adequate confidence that children's products tested by CPSC-accepted laboratories conform to applicable CPSC standards, regulations, rules, or bans. We are unclear which relevant international standards the commenter would like us to compare the notices of requirements and explain why differences between the two are necessary. To the extent that the commenter is asking for differences between various substantive safety standards, we again note that the notices of requirements do not affect the underlying consumer product safety standard or children's product safety rule.

C. Comments on the Suspension and/or Withdrawal of CPSC's Acceptance of Conformity Assessment Bodies

(

Comment 22

)—Some commenters suggested that if a third party conformity assessment body tested a product later found to be noncompliant with the applicable rules, that conformity assessment body should lose its accreditation temporarily. (We interpret “lose accreditation” to mean a loss of the CPSC's acceptance of their accreditation.) The commenters suggested varying loss schedules, depending on the type of laboratory, with increasing periods of suspension for repeat offenses. For firewalled and government laboratories, the commenters suggested that acceptance of their accreditation should be lost for three months after the first offense, six months after the second offense, one year after the third offense, and permanent loss for four offenses over a 2-year period. For independent laboratories, the commenters suggested a written warning after the first offense, a 1-month loss after the second offense, a 3-month loss after the third offense, and upon the fourth offense, the CPSC would reevaluate the laboratory's practices, and the accreditation body would conduct a reassessment.

(

Response 22

)—We decline to adopt the suggestion that laboratories lose CPSC acceptance of their accreditation (either for a specified time or permanently) after noncompliant products associated with the laboratories' test reports are found in the marketplace. Factors independent of the laboratory may have led to the presence of noncompliant products. For example, poor process control by the manufacturer after certification could lead to some noncompliant products being produced after the laboratory had tested compliant samples. As another example, a manufacturer may have made a material change to the product that affected the product's compliance, without sending samples for testing to a laboratory. Setting a withdrawal schedule based solely on the presence of noncompliant products would risk holding laboratories responsible for factors beyond their control and about which they had no knowledge.

In addition, we are not adopting a graduated system of penalties because we consider it preferable to deal with laboratory infractions on a case-by-case basis.

(

Comment 23

)—Some commenters suggested that we establish a defined system for “de-listing” a third party conformity assessment body “for just cause.” (We interpret “de-listing” to mean that the CPSC withdraws its acceptance of the laboratory's accreditation and removes the laboratory from the listing of accepted laboratories on the CPSC Web site

http://www.cpsc.gov/cgi-bin/labsearch

). The commenter provided examples of what would constitute “just cause”:

• Evidence of conflict of interest or where there is undue influence by a manufacturer, a common parent company, or other party, that could have affected test results;

• A laboratory has been found to be incompetent to conduct required testing due to personnel or laboratory equipment changes; or

• A laboratory has a record of repeatedly certifying products that are later identified as noncompliant.

(

Response 23

)—We agree with the commenter that there should be greater clarity of what conduct or circumstances are sufficient for the agency to withdraw its acceptance of the accreditation of a third party conformity assessment body. Subpart D of the proposed rule would address adverse actions that the CPSC may take against a laboratory. These adverse actions would include: withdrawing CPSC acceptance of a laboratory's accreditation and removing the laboratory from the CPSC Web site listing of accepted laboratories. Proposed § 1112.47 would establish three basic grounds for withdrawal, which would include a manufacturer, private labeler, or governmental entity exerting undue influence on the laboratory or otherwise interfering with or compromising the integrity of the testing process. Proposed § 1112.41 would establish the procedures for withdrawal.

D. Comments on Specific Notices of Requirements

1. Lead Content in Children's Metal Jewelry

(

Comment 24

)—Another commenter requested an exclusion in the CPSC test method for determining total lead in children's metal products (including children's metal jewelry). The commenter suggested that samples of electroplated jewelry—for which the electroplating is a metal excluded from testing for lead (such as gold or silver)—not be required to contain the electroplating when tested. The commenter suggested the following change to procedures A.2 and B.2:

Component parts of children's products, including metal jewelry items, generally weigh several grams or more, and an aliquot (with no paint or similar surface coating, but including any electroplated or other coating which is considered to be part of the substrate, excluding precious or other metals exempt from testing) will have to be obtained.

(

Response 24

)—We decline to make the suggested change to the CPSC test method, CPSC-CH-E1001-08, because test methods are an inappropriate place to list testing exclusions. The test method is limited to describing how to conduct a test, not whether a material should be tested.

The commenter is correct that an excluded material, such as gold of at least 10 karats, does not require testing for lead. On August 26, 2009, the Commission published in the

Federal Register

, a list of materials determined not to contain lead and excluded them from testing (74 FR, 43031). This created a new section, § 1500.91 of the

Hazardous Substances and Articles: Administration and Enforcement Regulations.

If the commenter submits samples for testing without the electroplating, those test results, combined with the exclusion for a plating material (such as gold greater than 10 karats) could be used as the basis for issuing a Children's Product Certificate for a finished product consisting of units from the same lot or batch as the samples, plus the electroplating. However, once the electroplating occurs, the combination of the base material and the electroplating are considered one component part. If finished product samples are submitted for testing, the electroplating must be part of the tested specimen.

(

Comment 25

)—A commenter urged the CPSC to consider X-ray fluorescence (XRF) spectrometry as a valid testing option to screen for products with very low lead levels; more precise testing would be required if the uncertainty range of the instrument included the lead concentration limit.

Another commenter urged the CPSC to consider the use of a specific XRF technology, energy dispersive- X-ray fluorescence spectrometry (EDXRF), as a validated method for the testing of lead in substrates of consumer products. The commenter referred to interlaboratory testing that compared EDXRF technology to “wet chemistry” techniques (Inductively Coupled Plasma and Atomic Absorption Spectrometry) to measure lead in multiple substrates. The commenter opined that the economic and other benefits of using EDXRF over “wet chemistry” may be even more pronounced with application to the nondestructive measurement of lead in the substrate of product samples.

(

Response 25

)—The CPSC has accepted the use of certain types of XRF testing but only for certain polymeric materials and for paints. The CPSC test method, CPSC-CH-E1002-08 (and its revision, CPSC-CH-E1002-8.1),

Standard Operating Procedure for Determining Total Lead (Pb) in Non-Metal Children's Products,

includes an option for the use of XRF for the analysis of lead in certain polymeric materials.

See

74 FR 55820 (Oct. 29, 2009) (notice of requirements for total lead in children's products);

see also

76 FR 6765 (Feb. 8, 2011) (notice extending the stay of enforcement pertaining to total lead content in children's products [except for metal components of children's metal jewelry] until December 31, 2011). ASTM International, formerly the American Society for Testing and Materials (ASTM) test method, F2853-10,

Standard Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogeneous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams,

can be used for the analysis of lead content in paints (16 CFR part 1303).

See

76 FR 18645 (Apr. 5, 2011) (revision to notice of requirements for lead paint).

This proposed rule also would allow the use of XRF to determine the lead content of glass materials, crystals, and certain metals. We will continue to evaluate improvements to technology and methods on an ongoing basis.

2. Total Lead in Children's (Metal and Non-Metal) Products

(

Comment 26

)—A commenter suggested that we expand the use of XRF beyond polymeric materials, to test paints and thin film coatings for the purposes of a manufacturer, importer, or retailer's providing certification. Another commenter said we should allow the XRF method described in ASTM F2853-10 to be used to measure lead content in multiple substrates, in addition to homogeneous polymeric materials.

(

Response 26

)—On April 5, 2011, we published a notice revising the requirements for accreditation of laboratories to test for lead in Paint. In that notice, the Commission approved the use of ASTM International (formerly the American Society for Testing Materials, ASTM) test method, F2853-10,

Standard Test Method for Determination of Lead in Paint Layers and Similar Coatings or in Substrates and Homogeneous Materials by Energy Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams,

for the analysis of lead content in paint. We have not determined that other XRF technologies are as effective, precise, or reliable as the methods described in the notice of requirements for compliance determinations of paints.

Additionally, the proposed rule (at proposed § 1112.15(b)(28), (29), and (30)) would allow the use of XRF to determine the lead content of glass materials, crystals, and certain metals. We will continue to evaluate improvements to technology and methods on an ongoing basis.

(

Comment 27

)—Another commenter suggested that, in addition to using a cryogenic mill for sample preparation, we should allow the test specimen to be cut into small representative pieces, with a maximum length in any dimension of 2.0 millimeters. The commenter also suggested a procedural change in the test method for determining lead in metals (CPSC-CH-E1001-08). The suggested change calls for the tester to observe when no particles are visible in one step and omits a heating period in another step.

(

Response 27

)—New revisions, dated June 21, 2010, of CPSC test methods: CPSC-CH-E1001-08.1 and CPSC-CH-E1002-08.1 have been posted on the CPSC's Web site. In test method CPSC-CH-E1002-08.1, the commenter's suggestion has been implemented. The sample preparation method instructs the tester to:

Cut the test specimen into small pieces. Hard-to-digest plastics may need to be cryomilled to get finer powder. The minimum size is left to the discretion and flexibility of the tester for the material being evaluated.

With regard to the suggested change in test method CPSC-CH-E1001-08, we do not have sufficient proof that the method of not heating the acid to 60 degrees C (in step 6 of the Hot Block method), or using a longer time period, would result in consistent measurements. In addition to the Hot Block Method, we allow another testing method, based on the EPA's method 3051A2, which uses microwave digestion. Both methods are allowed in the revised test method, CPSC-CH-E1001-08.1.

3. 16 CFR Part 1303—Lead in Paint

(

Comment 28

)—Two commenters noted that the absence of a specified testing method in 16 CFR part 1303,

Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint,

leads to uncertainty and confusion among accreditation bodies and laboratories about which testing methods are adequate for meeting the requirements of the standard.

(

Response 28

)—We addressed these comments in a notice published in the

Federal Register

on April 5, 2011, in which we amended the notice of requirements for testing for lead paint (

see

76 FR 18645). The notice of requirements listed the test methods that are approved for compliance determination: CPSC-CH-E1003-09, CPSC-CH-E1003-09.1 and/or ASTM

F2853-10 (which uses a specific type of XRF technology).

(

Comment 29

)—A commenter encouraged us to continue to ensure that the current ASTM F40 Committee (Declarable Substances in Materials) review process of a proposed standard method for lead in paint using traditional XRF technologies undergoes the same rigorous scientific and statistical requirements as we used during the ASTM F2853-10 standard method development process.

(

Response 29

)—We will continue to evaluate improvements to technology and methods on an ongoing basis. We have not determined that other XRF technologies are as effective, precise, or reliable as the methods described in the notice of requirements for determination of the lead content in paint.

4. 16 CFR Parts 1630 and 1631—Carpets and Rugs

(

Comment 30

)—A commenter requested that we continue the stay with respect to handmade “Oriental” carpets. The regulation at 16 CFR 1630.2(b) states: “[o]ne of a kind, carpet or rug, such as an antique, an Oriental, or a hide, may be excluded from testing under this Standard pursuant to conditions established by the Consumer Product Safety Commission.” There is a corresponding regulation applying to small carpets and rugs at 16 CFR 1631.2(b). The commenter noted that we have not established such conditions, and encouraged us to do so. Pending the establishment of the conditions, the commenter sought a continuation of the stay.

(

Response 30

)—We decline to continue (or reinstitute) the stay for handmade “Oriental” carpets. With regard to children's products, publication of the notice of requirements regarding carpets and rugs on July 21, 2010 had the effect of lifting the stay. With regard to non-children's products, we announced the lifting of this stay, effective January 26, 2011. 75 FR 81236, December 27, 2010. The CPSIA was enacted in August 2008; the carpets and rugs industry had ample opportunity to prepare for the law's testing and certification requirements.

In the years since the flammability regulations at 16 CFR parts 1630 and 1631 were promulgated, we have handled, on an individual basis, requests for exclusion of one-of-a-kind carpets or rugs. The commenter is correct that we have not formally established the conditions under which a carpet or rug would be excluded under 16 CFR 1630.2(b) and/or 1631.2(b), but such matters are outside the scope of this rulemaking.

(

Comment 31

)—Some commenters recommended that we support and approve the testing of flammability of carpets and rugs by laboratories accredited by the National Voluntary Laboratory Accreditation Program (NVLAP). One commenter added that this should also include “internal” laboratories. The commenters expressed the opinion that that the existing procedures (testing methods, protocols, and recordkeeping requirements) in FF 1-70 (16 CFR part 1630) and FF 2-70 (16 CFR part 1631) are effective in protecting consumers and children and that no additional safety benefit is gained by “different testing protocols.” One commenter expressed the belief that the requirement for accreditation of third party conformity assessment bodies to assess conformity with 16 CFR parts 1630 and/or 1631 will only add costs, with no additional safety benefits, for children's carpet and rug products.

(

Response 31

)—It is common for U.S. laboratories that test carpets and rugs in accordance with 16 CFR part 1630 and/or 1631 to be ISO/IEC 17025:2005-accredited by NVLAP. Because NVLAP is a signatory to the ILAC-MRA, it may be a Commission-designated accreditation body, as prescribed in the notices of requirements. Several NVLAP-accredited laboratories have been accepted and posted on our Web site for testing to 16 CFR parts 1630 and 1631. Worldwide, there are more than 25 CPSC-accepted laboratories for 16 CFR part 1630 and/or 16 CFR part 1631 (with several different ILAC-MRA accreditation bodies represented). Thus, NVLAP accreditation is not inconsistent with CPSC acceptance of third party conformity assessment bodies (laboratories) for testing to 16 CFR parts 1630 and/or 1631.

In response to the commenter who asked that we allow internal laboratories that are accredited by NVLAP, we interpret the comment as referring to laboratories that are owned by carpet or rug manufacturers. In these cases, the notice of requirements allows NVLAP accreditation to serve as a “baseline” requirement for CPSC acceptance. However, in accordance with the CPSA (as amended by the CPSIA), laboratories that are owned by a manufacturer of a product that is subject to the regulation for which it conducts tests must meet additional criteria for Commission acceptance as a firewalled third party conformity assessment body.

As for the commenters suggesting that the implementation of different testing protocols will provide no safety benefit, the notice of requirements makes no changes to the flammability test methods that appear in 16 CFR parts 1630 and 1631. The commenters may be referring to the language in section 14(a)(2) of the CPSA (as amended by the CPSIA) that the manufacturer “must submit sufficient samples of the children's product, or samples that are identical in all material respects to the product,” for testing by a CPSC-accepted third party conformity assessment body, and/or the CPSA language in section 14(i)(2)(B) related to Commission rulemaking for a continued testing program (including periodic and random sample testing, and compliance labeling). These “testing protocols” are required for children's carpets and rugs by the CPSIA and the recently issued final rule

Testing and Labeling Pertaining to Product Certification,

(76 FR 69482 (November 8, 2011) (to be codified at 16 CFR part 1107)).

(

Comment 32

)—One commenter asked whether conformity assessment bodies in its country that were accredited by a signatory to the ILAC-MRA and accredited to ISO 9239-1, 9239-2, and 6925 “fulfill the requirements listed in 16 CFR parts 1630 and 1631” or whether there are additional requirements that a conformity assessment body must meet to have CPSC accept its accreditation.

(

Response 32

)—The purpose of the CPSC's laboratory program is to authorize laboratories to conduct CPSC tests capable of supporting a Children's Product Certificate. Although there may be other product standards and test methods in existence, the purpose of this program is limited to conducting third party tests of children's products under section 14 of the CPSA. A laboratory must be accredited by an ILAC-MRA signatory to ISO/IEC 17025:2005 and must have the relevant CPSC regulation or test method in its scope of accreditation to apply successfully for CPSC acceptance of its accreditation. ISO 9239-1, 9239-2, and 6925 all specify methods for assessing the burning behavior of floorings and/or floor coverings. The CPSC regulations at 16 CFR parts 1630 and 1631 assess the surface flammability of carpets and rugs. To the extent that a laboratory was accredited to ISO/IEC 17025:2005, but it did not have 16 CFR part 1630 and/or 1631 in its scope of accreditation, it would not be eligible for acceptance by the CPSC to test children's products under 16 CFR part 1630 and/or 1631. The CPSC standards contain specific test methods for assessing compliance with CPSC requirements. Because other test methods do not assess for compliance with CPSC requirements, accreditation to such other test methods is not sufficient for CPSC acceptance of accreditation.

(

Comment 33

)—One commenter, a government agency, said that the notice of requirements raised serious concerns for the textile industry in its country and “may imply new additional costly requirements.”

(

Response 33

)—We believe that the commenter may have misinterpreted the notice of requirements. The regulations pertaining to carpets and rugs have been in place for several decades, and the notice of requirements did not alter those regulations. To the extent that the commenter is expressing concern over the cost of third party testing for children's products, such a comment is beyond the scope of the proposed rulemaking because this proposed rule would establish requirements for laboratories, and it would not address testing costs associated with manufacturers.

5. Requirements for Electrically Operated Toys or Other Electrically Operated Articles Intended for Use by Children

(

Comment 34

)—A commenter suggested that we should accept evaluation results from certification bodies recognized by OSHA as a NRTL with UL 696 in their scope of recognition. According to the commenter, the requirements in UL 696 are “nearly identical” to those in 16 CFR part 1505.

(

Response 34

)—As explained more fully above in the response to Comment 2, in order to ensure a consistent, global approach toward CPSC acceptance of accredited laboratories, we have decided to consider acceptance only of laboratories accredited by ILAC-MRA signatory accreditation bodies.

In addition, and as explained in the response to Comment 31, concerning carpets and rugs, a laboratory that wishes to conduct tests upon which a manufacturer of a children's product subject to a particular rule may base a certificate of compliance, must have that particular rule listed in its scope of accreditation. This requirement ensures that the laboratory understands the CPSC regulation and test methods associated with the regulation and has been evaluated as competent to conduct that testing. Although UL 696 has been revised to be consistent with 16 CFR 1505, an NRTL laboratory with UL 696 in its scope of recognition must be accredited to ISO/IEC 17025:2005 by an ILAC-MRA signatory accreditation body to 16 CFR part 1505 before the laboratory may apply to the CPSC for acceptance of that accreditation.

6. 16 CFR Parts 1632 and 1633—Mattresses, Mattress Pads, and Mattress Sets

(

Comment 35

)—One commenter urged us to adopt a longer implementation period for third party testing under 16 CFR part 1632 and to broaden this notice of requirements' retrospective testing provisions.

(

Response 35

)—We already responded to this comment in a notice published in the

Federal Register

on November, 29, 2010 (75 FR 72944), in which we revised the retrospective testing provision applicable to third party testing under 16 CFR parts 1632 and 1633.

7. 16 CFR Part 1420—Youth All-Terrain Vehicles (ATVs)

(

Comment 36

)—One commenter supported our publication of the notice of requirements for ATVs, and they specifically offered support for the “CPSC's analysis to determine whether an ATV is intended for a child and not just rely[ing] on what the ATV industry/manufacture[r] states that it is.” Some commenters expressed safety concerns with ATVs. Two commenters (49A, 51C) suggested that the CPSC include Y-12+ model ATVs in the “youth ATV” category, along with the Y-6+ and the Y-10+ models. One commenter claimed that the CPSC is excluding the Y-12+ model from the category “youth ATV.” The commenter stated that because the models are intended to be used by 12 year olds, they should fall under the scope of the CPSIA's definition of a “children's product.” Both commenters noted that because the T model ATV is intended for children 14 years old and older, the Y-12+ model will be used primarily by children 12 and 13 years old.

(

Response 36

)—Section 232 of the CPSIA required us to establish the American National Standard for Four-Wheel All-Terrain Vehicles Equipment Configuration, and Performance Requirements developed by the Specialty Vehicle Institute of America (American National Standard ANSI/SVIA-1-2007) as a mandatory standard for four-wheel all-terrain vehicles.

This standard includes “Category Y” classifications, which are for off-road use by operators under age 16. These categories are: Y-6+, intended for use by children age 6 or older; Y-10+, intended for use by children age 10 or older; Y-12+, intended for use by children age 12 or older; and T, intended for use by children age 14 or older with adult supervision, and by persons age 16 or older. While we appreciate the comment that a significant percentage of the riders of the Y-12+ model will be children 12 years old, and not the children who are older than 12, no data were provided to support that statement.

We do not have data to indicate which portion of the “12 or older” category represents the rider of Y-12+ ATV models most. The CPSIA defines a “children's product” in § 3(a)(2) of the CPSA as:

(2) CHILDREN'S PRODUCT.—The term “children's product” means a consumer product designed or intended primarily for children 12 years of age or younger. In determining whether a consumer product is primarily intended for a child 12 years of age or younger, the following factors shall be considered:

(A) A statement by a manufacturer about the intended use of such product, including a label on such product if such statement is reasonable.

(B) Whether the product is represented in its packaging, display, promotion, or advertising as appropriate for use by children 12 years of age or younger.

(C) Whether the product is commonly recognized by consumers as being intended for use by a child 12 years of age or younger.

(D) The Age Determination Guidelines issued by the Commission staff in September 2002, and any successor to such guidelines.

We cannot categorically include Y-12+ model ATVs as “youth ATVs” because the age range for that model includes children over the age of 12; however, the definition of a “children's product” is limited to products designed or intended primarily for children 12 years of age or younger. When it is unclear whether a product should be considered a children's product, we will apply the four factors. Different manufacturers may mark, package, and market their ATVs as primarily intended for children older than 12, or as primarily intended for 12 year olds. We will determine on a per-model basis, using the four factors listed above, whether a particular model Y-12+ ATV is primarily intended for use by children 12 years of age or younger (and is therefore considered a children's product in need of third party testing to support a certification). Indeed, some commenters commended the CPSC for applying the four statutory factors, rather than relying solely on the manufacturer's statements regarding whether an ATV is intended for a child.

The commenter is incorrect that we have excluded Y-12+ model ATVs from third party testing. In the notice of requirements that appeared in the

Federal Register

on August 27, 2010, we stated: “for the purposes of this notice of requirements, the term `youth' ATVs at a minimum refers to categories Y-6+ and Y-10+ in ANSI/SVIA 1-2007.” (

See

75 FR at 52616; emphasis added). Thus, we have indicated that the Y-12+ model may be considered for inclusion as a product that must meet third party testing requirements. Again, it will depend upon application of the four factors to a particular model.

On August 12, 2011, the President signed into law Public Law 112-28, which amended the CPSIA in several respects. One provision in PL 112-28 created an exception from the lead limits for off-highway vehicles. Consequently, ATVs, recreational off-highway vehicles, and snowmobiles are no longer subject to the lead limits in section 101 of the CPSIA. We also note that recently, a final rule revising 16 CFR part 1420, in which American National Standard ANSI/SVIA-1-2010 will become the new mandatory standard effective April 30, 2012, was published in the

Federal Register

.

See

77 FR 12197 (February 29, 2012). This standard, which pertains to ATVs, is an updated version of the standard that was the subject of the notice of requirements that appeared in the

Federal Register

of August 27, 2010 (75 FR 52616).

(

Comment 37

)—One commenter requested that we extend the date on which ATV manufacturers must begin third party testing and certification. The commenter further requested that we consider additional forms of relief if there continues to be an insufficient number of CPSC-accepted laboratories.

(

Response 37

)—We responded to this comment in notices published in the

Federal Register

on December 9, 2010 (75 FR 76709) and February 1, 2011 (76 FR 5565), in which we first extended, and then conditionally stayed, third party testing for youth ATVs.

Additionally, as noted in the response to Comment 36, all-terrain vehicles, recreational off-highway vehicles, and snowmobiles are no longer subject to the lead limits in section 101 of the CPSIA.

8. Toys and ASTM F 963

(

Comment 38

)—Two entities submitted letters before we published the notice of requirements pertaining to ASTM F-963-08 (76 FR 46598 (August 3, 2011)), and these letters were placed in the administrative record as comments. For convenience, we will refer to the entities as commenters. (We did receive a third submission, but it appeared to be from a laboratory seeking to be listed as a third party conformity assessment body, rather than a comment on the notices of requirements.)

One commenter urged us to refrain from issuing a notice of requirements to ASTM F 963 because it said that requiring third party testing would “dramatically and permanently harm small batch toymakers.” The commenter sought an indefinite stay of enforcement of the third party testing requirements for ASTM F 963 or delayed publication of the notice of requirements. The commenter cited testing costs, the impact of a third party testing requirement relative to the production of toys for the holiday season, the complexity of ASTM F 963, and congressional consideration of changes to the CPSIA.

Another commenter expressed concern about “potential confusion in the marketplace that may result from a lack of coordination between timing of the effective date” of a third party testing requirement and revisions to the ASTM F 963 toy standard. It recommended that we set the effective date of third party testing requirements to coincide with an expected revision of the toy standard and the date on which the revision would become a mandatory standard (as provided by section 106 of the CPSIA). It also urged us to clarify that, in cases where requirements overlap between versions of the standard, manufacturers do not need to test to demonstrate compliance with both standards. The commenter also sought flexibility on the acceptance of retrospective testing because, it explained, delays in our acceptance of third party conformity assessment body accreditation could force “redundant testing” on manufacturers who seek to test to new or revised standards before their effective date.

(

Response 38

)—With respect to the request to refrain from issuing the notice of requirements or to issue an indefinite stay of enforcement, we note that the notice of requirements with regard to ASTM F-963 published in the

Federal Register

on August 3, 2011 (76 FR 46598), and therefore, this comment is moot. Thus, the request to refrain from issuing the notice of requirements is moot. We also decline to issue an indefinite stay of enforcement. We note, however, that the notice of requirements, as well as changes resulting from Public Law 112-28, have addressed some of the commenter's concerns. For example, in the notice of requirements pertaining to ASTM F-963, the Commission stated that it would “stay enforcement of the testing and certification requirements of section 14 of the CPSA with respect to toys subject to ASTM F 963 until December 31, 2011” (76 FR at 46601). Public Law 112-28 also provided some relief, specifically to small batch manufacturers, through the creation of a new section 14(i)(4) of the CPSA, which establishes “special rules” for small batch manufacturers that would result in alternative testing requirements or exemptions from third party testing.

As for the second commenter's concern about effective dates, revisions to the toy standard, and potentially “redundant” testing, we are sensitive to potential disruptions and confusion that may result when standards are revised. The notice of requirements acknowledges that we anticipated another revision to ASTM F-963 and invited comment on “how to make the transition in testing requirements as clear and efficient as possible should the standard change” (76 FR at 46599). The enactment of Public Law 112-28 has magnified the need to develop policies with respect to transitions in testing requirements when standards change, because Public Law 112-28 revised section 104 of the CPSIA to establish a process for subsequent revisions to voluntary standards for durable infant and toddler products. The resulting process is similar to that under section 106 of the CPSIA (which pertains to toys and ASTM F-963). The issuance of future notices of requirements, relative to revised or changing standards, is complicated further by the fact that, after August 14, 2011, all notices of requirements are subject to the rulemaking requirements in 5 U.S.C. 553 and 601 through 612 of the Administrative Procedures Act.

Nevertheless, we agree that “redundant” testing should not be necessary when the relevant provision in the toy standard has not changed, or not changed in a manner that would affect how testing is conducted between revisions. For example, assume that a provision in the 2008 version of the standard imposed a particular test on a toy. If the standards organization revised the standard in 2011, such that a provision in the revised 2011 standard imposes the same test as the 2008 standard or a “functionally equivalent” test to the 2008 standard on the toy, then we believe it would be unnecessary to require manufacturers to take toys that had been tested to the 2008 standard and retest them to the 2011 standard. (By “functionally equivalent,” we mean that the standards organization has made certain changes in the revised standard, as compared to the earlier standard, but the changes are not substantial, and they do not affect the associated conformance testing.) Similarly, we believe that it is unnecessary, and contrary to public policy, to expect third party conformity assessment bodies that have been accredited to conduct that particular test under the 2008 standard, to cease

testing until they are reaccredited to the 2011 standard. Therefore, in those situations where the provisions in a revised toy standard are equivalent or functionally equivalent to the provisions in the earlier standard, we will continue to accept the accreditation of those third party conformity assessment bodies, and manufacturers should continue to have their toys tested and to issue certificates based on such testing. Third party conformity assessment bodies whose accreditation we had accepted to the 2008 standard should notify us when they become accredited to the 2011 standard by submitting an application through Form 223 on the CPSC Web site, and we will update our listing accordingly.

9. Phthalates

(

Comment 39

)—One commenter expressed appreciation for our inclusion of two test methods for phthalates (a revised CPSC test method and a Chinese test method) in the notice of requirements, but they asked us to allow for other “proven internal test methods.” The commenter explained that testing laboratories may modify existing test methods or develop their own methods for testing for phthalates; accordingly, they assert that restricting the notice of requirements to two test methods could result in manufacturers retesting products and testing backlogs at test laboratories. The commenter said we should allow other methods “as long as it can be shown that these are equivalent to the CSPC methods.” The commenter said that equivalency could be shown through side-by-side comparisons with the CPSC method, method validation data, participation in interlaboratory studies, or other requirements established by the CPSC.

Another commenter supported our inclusion of the revised CPSC test method and Chinese test method, but they asked that we consider Health Canada's test method for total phthalate content in PVC products. The commenter said that recognizing the Canadian test method would reduce redundant testing further, by enabling firms to certify compliance with U.S. and Canadian phthalate requirements using one test.

(

Response 39

)—We are receptive to considering other test methods and to adding those methods to a notice of requirements. Indeed, as our own experience with phthalates testing demonstrates, we have revised or refined our test method several times and added the Chinese test method to the notice of requirements for phthalates testing. Parties who believe that our accreditation criteria should be expanded to include a specific test method should contact us; or, alternatively, they should use the petition process at 16 CFR part 1051, to ask us to amend this rule (assuming that this rule is finalized). The commenter did not indicate a specific test method that we should allow to be used to determine phthalate concentrations. Thus, we cannot determine equivalency to our existing test methods.

With respect to the Canadian test method, we assume that the commenter is referring to

Determination of Phthalates in Polyvinyl Chloride Consumer Products,

Health Canada test method C-34. We share the desire to reduce the testing burden, where possible, through harmonization; and we developed CSPC test method CPSC-CH-C1001-09.3 (and its predecessors), specifically including the Health Canada Method C-34 for determining phthalates, as well as many other methods that were deemed acceptable as optional means of extraction and analysis of the phthalates in samples. Thus, tests by a CPSC-accepted testing laboratory using the C-34 test method are allowed for children's product certification purposes.

(

Comment 40

)—Two commenters sought clarification of what materials need to be tested for phthalates. One commenter referred to our “Statement of Policy: Testing of Component Parts with Respect to Section 108 of the CPSIA” (dated August 7, 2009) (“Statement of Policy”) to point out that the Statement of Policy gave examples of materials that do not normally contain phthalates and would not require testing or certification. The commenter then said that the notice of requirements caused confusion because a joint statement by a majority of the Commissioners indicated that the notice of requirements did not expand the universe of materials or products to be tested or certified and that the Statement of Policy remained in effect, yet the notice of requirements did not reflect the Statement of Policy. Thus, the commenter asked us to revise the notice of requirements to “specifically list all plastic materials that are known not to contain phthalates, including, but not limited to, those identified in the (Statement of Policy) * * * .” The commenter also provided a list of more than 30 plastic materials that it said are known not to contain phthalates.

The second commenter also referred to the Statement of Policy, but they asked that we revise the Statement of Policy to “make it clear * * * that the excluded material list compiled, is not exhaustive and similar, related or other such materials may not require testing and may be added in the future.” The commenter said, however, that “it is likely impossible to create an exhaustive list of

all

materials that may not include phthalates and therefore may not require testing” (emphasis in original).

(

Response 40

)—While we recognize the commenters' desire for greater clarification with respect to materials that may or may not contain phthalates, the principal purpose of a notice of requirements is to establish the criteria under which we will accept the accreditation of a third party conformity assessment body. In this instance, the notice of requirements identified the two test methods to which third party conformity assessment bodies should be accredited, and any information describing the materials that normally do not contain phthalates was intended to provide helpful guidance, rather than establish accreditation criteria. We acknowledge that the Statement of Policy discussed materials or products that are not known to contain phthalates and that the notice of requirements referred to the Statement of Policy and other previous CPSC documents; but that portion of the notice of requirements was intended to inform interested parties about those prior CPSC documents and to indicate that they remain in effect.

With respect to expanding the list of materials that may or may not contain phthalates and whether such a list should be part of a notice of requirements, we will consider whether additional guidance on materials containing or not containing phthalates should be developed. We decline, however, to include such a list in a notice of requirements or this rulemaking. Our experience indicates that when a regulation or document attempts to provide a list of examples, often the list is construed to be exhaustive or definitive, resulting in multiple requests to amend the rule or revise the document to add or delete items from the list. Given our scarce resources, and for the reasons mentioned in this response, we do not believe it would be prudent to include as part of this rulemaking, a list of materials containing phthalates or a list of materials known not to contain phthalates.

(

Comment 41

)—One commenter discussed Public Law 112-28 and the exception it created for inaccessible component parts containing phthalates. In brief, section 5 of Public Law 112-28 amended section 108 of the CPSIA to create an exclusion for “inaccessible component parts.” The commenter sought clear direction from us about “how the phthalate standard will apply

to inaccessible components” and asked that we “immediately amend the Statement of Policy to clarify that inaccessible components are exempt from the phthalate standard and therefore exempt from third party testing.”

(

Response 41

)—We published the Statement of Policy and the notice of requirements before Public Law 112-28 was enacted. Thus, issues concerning implementation of the phthalates provision in Public Law 112-28 and revisions to the Statement of Policy are outside the scope of the notice of requirements and this rulemaking. Further, the notice of requirements establishes the criteria and process for CPSC acceptance of accreditation of laboratories for testing children's products under section 14 of the CPSA. Determination of which component parts require testing is outside the scope of a notice of requirements.

(

Comment 42

)—One commenter said that because phthalates are added intentionally to some plastics, paints, and other materials and are not ubiquitous environmental contaminants, manufacturers of products “produced exclusively from materials on the phthalate exclusion list (or other materials not likely to contain phthalates)” are “generally able to be certain that they are not intentionally adding phthalates and that phthalate-containing materials are not present in their factories.” The commenter asked that we “explicitly recognize such knowledge as a reasonable basis for certifying compliance” with the phthalates limits and “allow self-certification by such entities.”

(

Response 42

)—We decline to revise the notice of requirements or draft this rule to incorporate the commenter's suggestion. Section 14(a)(2) of the CPSA is clear that, with respect to children's products, a manufacturer must certify the product based upon testing by a third party conformity assessment body accredited under section 14(a)(3) of the CPSA. Self-certification based upon a manufacturer's knowledge would not be consistent with section 14(a)(2) of the CPSA.

E. Miscellaneous Comments

(

Comment 43

)—One commenter agreed with the notice of requirements for 16 CFR part 1505,

Requirements for Electrically Operated Toys or other Electrically Operated Articles Intended for Use by Children,

and 16 CFR 1500.86(a)(5) (Clacker Balls) and suggested that officials be sent to manufacturer sites (domestic and foreign) to conduct audits to see that the tests are performed properly and to ensure that the manufacturers do perform all steps of the tests submitted by them to the accredited agencies.

(

Response 43

)—The commenter may have misunderstood the notice of requirements. The tests to assess compliance are performed at laboratories, not at manufacturing sites (unless a manufacturing site has a firewalled laboratory). If the commenter is referring to firewalled laboratories or third party laboratories, in general, we have designated accreditation bodies that are signatories to the ILAC-MRA to conduct accreditation of third party conformity assessment bodies to be accepted by the Commission. ILAC-MRA signatories visit independent and firewalled laboratories during initial assessments and regular reassessments to assess the laboratory's continued compliance to the requirements of ISO/IEC 17025:2005. In every assessment and reassessment, the accreditation body must demonstrate that it has adequately assessed all of the laboratory's technical competencies and management systems competencies (as prescribed in ISO/IEC 17025:2005) associated with its scope of testing.

(

Comment 44

)—Most notices of requirements included provisions allowing certificates of compliance to be based on testing performed by an accredited third party conformity assessment body before the Commission accepts the laboratory's accreditation. This practice is sometimes referred to as allowing “retrospective” testing. In the notices of requirements, we prescribed particular circumstances under which retrospective testing could support a Children's Product Certificate. For example, we stated that the product should be tested by a third party conformity assessment body that was, at the time of product testing, ISO/IEC 17025:2005 accredited by an ILAC-MRA signatory accreditation body; the accreditation scope in effect at the time of testing had to include testing to the regulation or test method identified in the notice; and we placed constraints on how far back in time the retrospective testing could occur. Initially, we did not allow any retrospective testing by firewalled laboratories. Later, we allowed retrospective testing by firewalled laboratories, if the firewalled laboratory had already been accepted by an order of the Commission for testing to a test method or regulation specified in an earlier notice of requirements.

A commenter, in response to an earlier notice of requirements, supported the position of not allowing any retrospective testing by firewalled laboratories. This commenter viewed the position of not allowing any retrospective testing by firewalled laboratories as a way to reduce any possible conflicts of interest and to ensure that no undue influence occurred in the certification process.

(

Response 44

)—If we have already accepted a laboratory as firewalled, we consider the laboratory to have shown previously that it has policies and procedures in place consistent with laboratory independence and impartiality. We will monitor this policy, and, if necessary, revise it in future rulemakings. We note that because retrospective testing issues arise only when a third party testing requirement for a particular rule or standard begins, this proposed rule would not address retrospective testing.

(

Comment 45

)—Some commenters argued that the CPSA, as amended by the CPSIA, does not require third party testing of children's products that are subject to a regulation of general applicability (

e.g.,

16 CFR 1610,

Standard For the Flammability of Clothing Textiles

). In the view of these commenters, the only children's products for which third party testing is required are those children's products subject to a regulation whose reach is limited to children's products (

e.g.,

16 CFR 1615, 1616,

Standard for the Flammability of Children's Sleepwear

). One commenter stated that the safety of children's products subject to rules of general applicability can be assured via the General Comformity Certificates that are required for non-children's products under section 14(a)(1) of the amended CPSA.

Some of the commenters who disagreed that the amended CPSA requires third party testing of children's products subject to rules of general applicability asserted that, even if the Commission views the text of the statute as requiring third party testing for such products, we should, nevertheless, use our implementing authority under section 3 of the CPSIA to limit the third party testing requirement to rules of limited applicability—that is, rules applicable solely to children's products. Similarly, one commenter urged the Commission to use authority granted in section 14(b) of the CPSA to “assess the necessity of third party testing on a case-by-case basis.”

One commenter argued that we have been inconsistent in describing what constitutes a “children's product safety rule.” The commenter noted that in the proposed rule on “Testing and Labeling Pertaining to Product Certification,” we stated: “[c]urrently, the rule on children's bicycle helmets is the only children's product safety rule that contains requirements for a reasonable

testing program.” 75 FR 28336, 28348 (May 20, 2010). Because the FFA regulations, such as 16 CFR part 1610,

Standard for the Flammability of Clothing Textiles,

contain reasonable testing programs, the commenter asserted that we must not consider FFA regulations to be children's product safety rules. The commenter argued that we should offer the reasonable testing program requirements in 16 CFR part 1610 the same treatment we have afforded all children's product safety rules with existing reasonable testing programs (

e.g.,

bicycle helmets).

(

Response 45

)—Section 14(a)(2) of the CPSA requires manufacturers and private labelers of a children's product subject to a children's product safety rule to certify that their children's product complies with the relevant children's product safety rule. Section 14(f)(1) of the CPSA defines “children's product safety rule” as “a consumer product safety rule under this Act 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.” 15 U.S.C. 2063(f)(1).

Thus, the statute defines a “children's product safety rule” to mean a consumer product safety rule. The Commission has taken the position that the statute requires third party testing to support a certification of a children's product if that children's product is subject to a consumer product safety rule. A “consumer product safety rule” becomes a “children's product safety rule”—not when the product subject to the rule is limited to children's products—but rather, when the product subject to the rule includes children's products.

With regard to the comment that a General Conformity Certificate would adequately assure the safety of children's products, we again refer to the statute. Section 14(a)(2) of the CPSA states that a certification based on third party testing is required for “any children's product that is subject to a children's product safety rule.” General Conformity Certificates are required for non-children's products and are not required to be based on third party testing. However, Public Law 112-28 allows small batch manufacturers to use alternative testing requirements once the Commission has identified such testing requirements, or they are allowed an exemption if the Commission determines that no alternative testing requirement is available or economically practicable.

As for the comment regarding section 3 of the CPSIA, the statute gives us some latitude in implementing the CPSIA, but it does not authorize us to avoid implementing the statute altogether. Courts have held that an agency's authority to implement a new statute does not encompass avoiding the statutory obligation itself.

See U.S.

v.

Markgraf,

736 F.2d 1179, 1183 (7th Cir. 1984) (“An administrative agency cannot abdicate its responsibility to implement statutory standards under the guise of determining that inaction is the best method of implementation.”).

See also

Friends of the Earth, Inc.

v.

EPA,

446 F.3d 140, 145 (DC Cir. 2006) (An administrative agency may not avoid the plain language of a statute by asserting that its preferred approach would be better policy; nor can a court “set aside a statute's plain language simply because the agency thinks it leads to undesirable consequences in some applications.”)

Finally, the comment regarding inconsistency in determining what is a children's product safety rule was submitted in response to the notice of requirements for clothing textiles, which was published on August 18, 2010—several months after publication of the proposed rule on “Testing and Labeling Pertaining to Product Certification.” The publication of the clothing textiles notice of requirements clearly indicates that the Commission decided that the clothing textiles standard is a children's product safety rule. In fact, the Commission reaffirmed its position when it revised the clothing textiles notice of requirements on April 22, 2011.

See

76 FR 22608. The Commission also issued other FFA-related notices of requirements subsequent to the publication of the proposed rule on “Testing and Labeling Pertaining to Product Certification.”

See, e.g.,

75 FR 42311 (July 21, 2011). Accordingly, we consider the quoted sentence in the preamble to the proposed rule on “Testing and Labeling Pertaining to Product Certification” to be in error because, as shown by subsequent CPSC actions, FFA regulations may be children's product safety rules and the subject of a notice of requirements.

(

Comment 46

)—Some commenters expressed concern over the cost of third party testing. One commenter noted, in particular, that for regulations under the Flammable Fabrics Act (FFA), 15 U.S.C. 1191-1204, the tests involve hazards, which could result in “required testing of additional samples, longer lead times for testing, and added expenses.” Some commenters urged a thorough cost-benefit analysis of the CPSC's rules related to testing and certification, component parts, and/or the notices of requirements. Some of these commenters argued that the additional cost of third party testing carries no benefit because third party testing does not enhance product safety.

Another commenter stated that “[r]equiring third party testing further triggers compliance” with requirements under the two recent notices of proposed rulemaking (NPRs),

Testing and Labeling Pertaining to Product Certification

(to be codified at 16 CFR 1107) (75 FR 28336 (May 20, 2010) and

Conditions and Requirements for Testing Component Parts of Consumer Products

(to be codified at 16 CFR 1109) (75 FR 28208 (May 20, 2010)). The commenter opined that “these regulatory burdens dilute the focus from * * * ensuring that the product is safe and compliant with regulatory standards.”

(

Response 46

)—We are sensitive to testing cost concerns and note that Public Law 112-28 expressly required us to seek public comment on opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation and listed seven issues for public comment. In the

Federal Register

of November 8, 2011 (76 FR 65956), we invited comment on the seven issues and on opportunities to reduce the cost of third party testing requirements. The comment period for the notice ended on January 23, 2012, and we will address the comments in a separate proceeding.

However, with respect to conducting cost-benefit analyses for the rules identified in the comment, the CPSIA did not require us to conduct such analyses. We also note that we issued final rules on “Testing and Labeling Pertaining to Product Certification” (76 FR 69482 (November 8, 2011)) and “Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements” (76 FR 69546 (November 8, 2011)). The preamble to the final rule on “Testing and Labeling Pertaining to Product Certification” summarized and responded to a similar comment on cost-benefit analyses (

see

76 FR at 69484 (comment 2 and response)).

Yet, with respect to the comment that a notice of requirements somehow “triggers compliance” with these two rules, we disagree. A notice of requirements establishes the criteria under which we will accept the accreditation of a third party conformity assessment body to test children's

products for compliance to a children's product safety rule. Section 14(a)(3)(A) of the CPSA states that the third party testing requirement applies to any children's product manufactured more than 90 days after we have established and published the notice of requirements. Section 14(i)(2) of the CPSA creates the obligation for continuing testing. In any event, the final rule on “Testing and Labeling Pertaining to Product Certification” does not become effective until February 8, 2013. The final rule on “Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements,” while effective on December 8, 2011, pertained to the conditions and requirements under which passing component part test reports, certification of component parts of consumer products, or finished product testing or certification procured or issued by another party, can be used to meet, in whole or in part, the testing and certification requirements of sections 14(a) and 14(i) of the CPSA. As such, component part testing as described by that final rule is voluntary, rather than mandatory.

(

Comment 47

)—One commenter asserted that requiring manufacturers of children's clothing textiles subject to the FFA regulations at 16 CFR part 1610,

Standard for the Flammability of Clothing Textiles,

to issue certifications based on third party testing “bypasses the entire FFA rulemaking process.” The commenter argued that section 4(b) of the FFA requires that regulations or amendments to regulations be based on certain findings that the CPSC has not made, and argued that we have effectively amended part 1610 to require third party testing of children's clothing textiles. The commenter stated that when the test methods in part 1610 were promulgated, and “[i]n accordance with Section 4(b) of the FFA,” the CPSC hosted several meetings attended by industry and testing representatives, who worked cooperatively to develop test methods that the representatives and CPSC agreed were appropriate to assess compliance with the flammability standards. The commenter stated that the third party testing requirements, along with the requirements proposed in the testing and labeling and component parts NPRs, “entirely undermine this cooperative effort.”

This commenter also asserted that the testing requirements in part 1610 are sufficient for children's products subject to those regulations, and that requiring third party testing does not provide additional assurance of the product's ability to pass the applicable product safety standard. The commenter asked the Commission to hold a public meeting if we do not agree that the testing regime under part 1610 is sufficient for the industry to demonstrate compliance with the standard.

(

Response 47

)—The purpose of the

Standard for the Flammability of Clothing Textiles

is to keep dangerously flammable textiles and garments made of these textiles out of commerce. The standard provides methods of testing the flammability of clothing and textiles intended to be used for clothing by classifying fabrics into three classes of flammability based on their speed of burning. The CPSC has not amended 16 CFR part 1610 by implementing the third party testing requirements of section 14 of the CPSA.

Section 4 of the FFA prescribes the process for promulgating a regulation under that statute. Section 4(b) of the FFA requires, in relevant part, that each FFA “standard, regulation, or amendment thereto * * * be based on findings that such standard, regulation, or amendment thereto is needed to adequately protect the public against unreasonable risk of the occurrence of fire leading to death, injury, or significant property damage, is reasonable, technologically practicable, and appropriate.” 15 U.S.C. 1193(b). Section 4(b) of the FFA does not mandate consultation with industry. It requires findings in support of an FFA regulation. The fact that industry representatives cooperated with the CPSC when part 1610 was promulgated does not mean that the CPSC, in implementing section 14(a)(3)(B)(vi) of the CPSA, must host meetings before issuing a notice of requirements. Therefore, we decline the commenter's suggestion to hold a public meeting on this matter.

With regard to the commenter's assertion that tests conducted under part 1610 sufficiently assure compliance with the standard, and therefore, third party testing is not necessary, we note that, absent the CPSIA, a manufacturer of a clothing textile was not required to conduct the test prescribed by part 1610 at all. If the manufacturer wished to issue an FFA guaranty that the product complied with part 1610, then the manufacturer had to conduct the tests prescribed by part 1610, but that testing was entirely optional.

(

Comment 48

)—One commenter stated that the Commission should have allowed 60 days for the comments to be submitted in response to the notices of requirements, noting that the TBT Committee has recommended 60-day comment periods. This commenter also observed that the notice of requirements was effective on publication; thus, there was no opportunity to comment prior to the notice taking effect.

(

Response 48

)—The notices of requirements that invited public comments have all contained a 30-day comment period and have all been effective upon publication. Nevertheless, this proposed rule provides a 75-day comment period. The public may comment on all aspects of the proposal, even those parts that were previously included in the notices of requirements.

F. Comments Considered Out of Scope

Several commenters raised issues that were not present in the notices of requirements and are not directly relevant to this proposed rule; such issues, therefore, are outside the scope of this rulemaking.

(

Comment 49

)—One commenter recommended that we address the procedures for filing certificates of compliance, including who “owns” the certificate and what is the required retention period for certificates.

(

Response 49

)—This issue is outside the scope of this rulemaking because neither the notices of requirements, nor this proposed rule, concern the requirements or processes for certificates of compliance. We note that the recently issued final rule,

Testing and Labeling Pertaining to Product Certification

(76 FR 69482 (November 8, 2011) (to be codified at 16 CFR part 1107)), addresses the length of time manufacturers are required to keep records of certificates of compliance.

(

Comment 50

)—One commenter suggested that we specify what will be considered “sufficient samples” of a children's product to submit for third party testing. The commenter was concerned that different laboratories would require different sampling schedules, and they suggested that manufacturers might choose to use laboratories that require the least onerous sampling schedule. The commenter recommended that we prescribe a specific, testing schedule based on a statistical scheme for sample product runs of the children's products. The commenter also suggested that the number of samples selected for testing should be based on the size and duration of the production run of the children's product.

(

Response 50

)—The proposed rule is limited to establishing the requirements for conformity assessment bodies in order for their test results to be used for

children's product certification purposes. The certifier, not the laboratory, determines what constitutes a sufficient number of samples to test for certification. The recently issued final rule on

Testing and Labeling Pertaining to Product Certification

(76 FR 69482 (November 8, 2011) (to be codified at 16 CFR part 1107)), addresses sample size issues to a certain extent, and we also issued a proposed rule pertaining to “representative samples” (76 FR 69586 (November 8, 2011)), pursuant to Public Law 112-28.

(

Comment 51

)—One commenter stated: “component or raw material testing is another major concern,” and they urged that “allowing for reasonable component testing is a critical need to avoid a crushing financial burden on small businesses.”

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Response 51

)—This rulemaking is limited to the requirements related to the accreditation of third party conformity assessment bodies. Whether and under what circumstances component parts of children's products may be third party tested separately in support a certificate of compliance is not related to the criteria and process for CPSC acceptance of the accreditation of third party conformity assessment bodies. The recently issued final rule,

Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party's Finished Product Testing or Certification, to Meet Testing and Certification Requirements

(76 FR 69546 (November 8, 2011) (to be codified at 16 CFR part 1109)), should address the commenter's concerns.

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Comment 52

)—Some commenters described their opinions concerning whether third party testing of children's products for lead content should be required. Overall, the commenters supported third party testing in this context.

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Response 52

)—Section 101 of the CPSIA established the lead content limits for children's products. Section 14(a)(2)(A) of the CPSA requires manufacturers of children's products to submit samples of a children's product to a third party conformity assessment body for testing as a basis for certifying the children's product. These comments refer to the statutory requirements and are beyond the scope of this proposed rulemaking.

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Comment 53

)—In response to the notice of requirements for accreditation of third party conformity assessment bodies to assess conformity of youth products under the CPSC regulation on ATVs (16 CFR part 1420), one commenter urged that children younger than the age at which one can legally drive traditional motor vehicles should not be allowed to operate ATVs. In the view of this commenter, ATVs have become a serious public health concern for children. The commenter described study findings and statistics in support of his view.

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Response 53

)—The notice of requirements related to ATVs provided the criteria and processes for CPSC acceptance of the accreditation of laboratories that will be able to conduct the third party tests of youth ATVs that may support manufacturers' certificates of compliance with 16 CFR part 1420. Therefore, the question of whether children should be allowed to operate ATVs is beyond the scope of the ATV notice of requirements and the proposed rule.

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Comment 54

)—Several commenters remarked on the cost of complying with the lead content requirements in the context of small businesses selling handcrafted items. One commenter remarked that handcrafted, one-of-a-kind items cannot each be destructively tested. The commenter suggested that our regulations mirror California's Lead-Containing Jewelry Law, AB 2901. Another commenter asked if the regulations had exceptions to the testing requirements. Another commenter stated that the testing costs will tend to decrease consumer options because small manufacturers will not be able to stay in business. The commenter's main concern was that all “units” of children's items must be tested for lead content and phthalates, and that relying on testing by suppliers is not sufficient. The commenter offered the following suggestions:

1. Waive the testing requirements for small-volume manufacturers, such as those with less than $1 million in revenue in the United States.

2. If a waiver is not possible, provide free testing to small businesses that produce children's products.

3. Allow third party certification of components from manufacturers to be used as a basis for a finished product certificate.

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Response 54

)—The scope of this proposed rule is limited to the requirements related to the accreditation of third party conformity assessment bodies. This rulemaking does not address the requirements related to the testing and certification of consumer products. Therefore, these comments are beyond the scope of this proposed rule.

Additionally, one provision in Public Law 112-28 directs us to seek public comment on seven specific issues, including:

• The extent to which modification of the certification requirements may have the effect of reducing redundant third party testing by or on behalf of two or more importers of a product that is substantially similar or identical in all material respects;

• The extent to which products with a substantial number of different components subject to third party testing may be evaluated to show compliance with an applicable rule, ban, standard, or regulation by third party testing of a subset of such components selected by a third party conformity assessment body;

• The extent to which manufacturers with a substantial number of substantially similar

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