31086 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

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 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31087 

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 


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31088 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

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 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31089 

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-FullSize 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. 


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TABLE 1—NOTICES OF REQUIREMENTS ISSUED WITH COMMENTS RECEIVED—Continued 

Regulation or product(s) Federal Register citation Regulations.gov 

docket No. 

CPSC–CH–C1001–09.3 .......................................................... 76 FR 49286 (August 10, 2011) ........................................... CPSC–2011–0052. 

1We 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 


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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. 

(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. 

(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. 

(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. 

(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 


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document mirrors many widelyaccepted 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. 

(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. 

(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. 

(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. 

(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 

(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. 

(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 CPSCaccepted laboratory (referred to in the 

CPSA as third party conformity 


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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. 

(Comment 9)—One commenter urged 

the CPSC to ‘‘differentiate between what 

are authentic, third party conformity 

assessment bodies from manufacturerowned, 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. 

(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. 

(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. 

(Response 10)—The CPSA includes a 

provision that requires all CPSCaccepted 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 


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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. 

(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. 

(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. 

(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. 

(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. 

(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 


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limited to, extensive public disclosure 

of both manufacturer and/or 

government laboratory personnel 

involved in the testing of the relevant 

product(s).’’ 

(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’’). 

(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. 

(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). 

(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. 

(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 


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personnel would be helpful, we may 

recommend adopting additional training 

requirements in the future. 

(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. 

(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. 

(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. 

(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. 

(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.’’ 

(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. 

(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 


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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 


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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. 


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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 NonMetal 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 LeadContaining 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 


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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 CPSCaccepted 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. 


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(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 FourWheel 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 permodel 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 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
31102 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

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 offhighway 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 


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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 


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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 phthalatecontaining 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 selfcertification 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 


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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 FFArelated 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 costbenefit 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 


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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 


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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.’’ 

(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. 

(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. 

(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. 

(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. 

(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. 

(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-akind items cannot each be destructively 

tested. The commenter suggested that 

our regulations mirror California’s LeadContaining 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. 

(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 

products subject to third party testing may 

reasonably make use of sampling procedures 

that reduce the overall test burden without 

compromising the benefits of third party 

testing; and 

• Other techniques for lowering the cost of 

third party testing consistent with assuring 

compliance with the applicable consumer 

product safety rules, bans, standards, and 

regulations. 

Recently, we published a Federal 

Register notice seeking public comment 

on issues regarding reducing the testing 

burden for children’s product certifiers. 

See Application of Third Party Testing 

Requirements; Reducing Third Party 

Testing Burdens (76 FR 69596 

(November 8, 2011)). Public Law 112–28 

also requires us to review the public 

comments, and it states that we may 

prescribe new or revised third party 

testing regulations if we determine that 

such regulations will reduce third party 

testing costs consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations. 

(Comment 55)—One commenter 

raised concerns that the third party 

testing requirements would create a 

competitive advantage for the larger 

firms and drive many small businesses 

out of the market. The commenter 

recommended that the law (presumably 

the CPSIA) be amended to focus on 

manufacturers directly linked to the 

production of unsafe products for 

children and penalize them, as opposed 

to penalizing the small business 

community. 

(Response 55)—The commenter may 

have misunderstood the purpose of a 

notice of requirements. A notice of 

requirements establishes the 

accreditation requirements for 

laboratories to test for compliance to 

specific rules, bans, standards, or 

regulations. It does not establish 

requirements for manufacturers, other 

than establishing a date by which 

children’s products must be certified 

based on third party testing results. 

Therefore, issues pertaining to statutory 

amendments, the effects of third party 

testing on small businesses, and 

penalties for manufacturers, are all 

beyond the scope of this proposed rule. 


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As discussed in the response to 

Comment 49, we have published a 

notice in the Federal Register (76 FR 

69596) seeking public comment on 

issues regarding reducing the testing 

burden for children’s product certifiers. 

Further, Public Law 112–28 created a 

new section 14(i)(4) of the CPSA to 

provide for special rules for small batch 

manufacturers. The provision 

contemplates the possible development 

of alternative testing requirements for 

‘‘covered products’’ made by ‘‘small 

batch manufacturers’’ and defines the 

terms ‘‘covered product’’ and ‘‘small 

batch manufacturer.’’ The provision also 

provides for possible exemptions of 

small batch manufacturers from the 

third party testing requirements and 

imposes certain limits on third party 

testing requirements. 

IV. Description of the Proposed Rule 

The proposed rule would consist of 

four subparts. Subpart A, ‘‘Purpose and 

Definitions,’’ is created by the audit 

final rule published elsewhere in this 

issue of the Federal Register. This 

proposed rule would add to subpart A, 

a section describing the purpose of part 

1112; it would amend two definitions 

contained in the audit final rule; and it 

would add several new definitions. In 

addition, the audit final rule reserved a 

subpart B in part 1112; this proposed 

rule would create subpart B, which 

would contain the principal 

requirements for third party conformity 

assessment bodies, including how a 

laboratory may obtain CPSC acceptance 

of its accreditation. Subpart C addresses 

audits, and it is the core of the audit 

final rule (published elsewhere in this 

issue of the Federal Register). The 

proposed rule, however, would add a 

provision to subpart C, addressing the 

timing of audits. The proposed rule also 

would create a subpart D, addressing 

adverse actions that we may take against 

CPSC-accepted third party conformity 

assessment bodies. Finally, the 

proposed rule would make limited 

changes to § 1118.2, the Commission’s 

regulation on the conduct and scope of 

inspections, to conform with part 1112. 

At the outset, we note that section 

14(f)(2)(D) of the CPSA requires that the 

acceptance of the accreditation of a 

firewalled laboratory occur by order of 

the Commission. Consistent with this 

provision, the Commission considers 

that any removal of the acceptance of 

the accreditation of a firewalled 

laboratory (whether by suspension or 

withdrawal) also must occur by order of 

the Commission. The Commission may 

delegate other functions and powers 

described in this part to CPSC staff, 

under 16 CFR § 1000.11. (Due to this 

distinction between functions that the 

Commission as a body of appointed 

Commissioners must discharge, and 

other functions that the agency may 

discharge via staff activity, from this 

point forward in this preamble, we 

attempt to distinguish between the 

Commission as a body (‘‘Commission’’) 

and the CPSC as an agency (‘‘CPSC’’).) 

A. Subpart A—Purpose and Definitions 

1. Proposed § 1112.1—Purpose 

Proposed § 1112.1 would describe the 

major topics addressed in part 1112. It 

would note that the part defines the 

term ‘‘third party conformity assessment 

body’’ and describes the types of third 

party conformity assessment bodies 

whose accreditations are accepted by 

the CPSC to test children’s products 

under section 14 of the CPSA. It would 

note that part 1112 describes the 

requirements and procedures for 

becoming a CPSC-accepted third party 

conformity assessment body; the audit 

requirement applicable to third party 

conformity assessment bodies; how a 

third party conformity assessment body 

may voluntarily discontinue 

participation as a CPSC-accepted third 

party conformity assessment body; the 

grounds and procedures for withdrawal 

or suspension of CPSC acceptance of 

accreditation of a third party conformity 

assessment body; and how an 

individual may submit information 

alleging grounds for adverse action. 

2. Proposed § 1112.3—Definitions 

The proposed rule would add a 

sentence preceding the definitions, to 

clarify that the definitions in this 

section apply for purposes of this part. 

(i) Revised Definitions 

Proposed § 1112.3 would amend two 

definitions that appear in the audit final 

rule, which published elsewhere in this 

issue of the Federal Register. The two 

definitions to be amended are: 

Audit: An audit of a CPSC-accepted 

laboratory consists of two parts: the 

reassessment portion, which is 

conducted by the accreditation body, 

and the examination portion, which is 

conducted by the CPSC. Currently, the 

definition of audit describes the 

examination portion as: 

The resubmission of the ‘‘Consumer 

Product Conformity Assessment Body 

Acceptance Registration Form’’ (CPSC Form 

223) by the third party conformity 

assessment body and the Consumer Product 

Safety Commission’s (‘‘CPSC’s’’) examination 

of the resubmitted CPSC Form 223. If the 

third party conformity assessment body is 

owned, managed, or controlled by a 

manufacturer or private labeler (also known 

as a ‘‘firewalled’’ conformity assessment 

body) or is a government-owned or 

government-controlled conformity 

assessment body, the CPSC’s examination 

may include verification to ensure that the 

entity continues to meet the appropriate 

statutory criteria pertaining to such 

conformity assessment bodies. 

To this portion of the definition, the 

proposed rule would add the words, 

‘‘and accompanying documentation’’ 

twice, after each mention of the CPSC 

Form 223. The proposed rule would 

delete the second sentence and replace 

it with the following two sentences: 

Accompanying documentation includes 

the baseline documents required of all 

applicants in § 1112.13(a), the documents 

required of firewalled applicants in 

§ 1112.13(b)(2), and/or the documents 

required of governmental applicants in 

§ 1112.13(c)(2). 

Documents beyond the baseline 

documents are required of firewalled 

and governmental applicants so that the 

CPSC’s examination may include 

verification to ensure that the entity 

continues to meet the appropriate 

statutory criteria pertaining to such 

third party conformity assessment 

bodies. These changes would clarify 

which materials must be submitted at 

audit. As the purpose of the audit is to 

confirm that the laboratory continues to 

meet the requirements of CPSC 

acceptance, all laboratories would be 

required to submit the baseline 

documentation. 

CPSC: The audit final rule defines 

‘‘CPSC’’ to mean the U.S. Consumer 

Product Safety Commission. The 

proposed rule would discuss certain 

tasks that must be accomplished by the 

actual Commission body, as opposed to 

the CPSC as an agency. Thus, to 

distinguish between the Commission, as 

a body, as opposed to the agency, as a 

whole, the proposed rule, for purposes 

of part 1112 only, would revise the 

definition of ‘‘CPSC’’ to mean the U.S. 

Consumer Product Safety Commission 

as an agency. 

(ii) New Definitions 

Proposed § 1112.3 would create the 

following nine definitions: 

Accept accreditation: The proposed 

rule would define this term consistent 

with its use in section 14 of the CPSA. 

See, e.g., 15 U.S.C. 2063(e)(1). It would 

mean that the CPSC has positively 

disposed of an application by a third 

party conformity assessment body to 

test children’s products pursuant to a 

particular children’s product safety rule, 

for purposes of the testing required in 

section 14 of the CPSA. 

Commission: We would define 

‘‘Commission’’ to mean the body of 

Commissioners appointed to the U.S. 


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Consumer Product Safety Commission. 

In contrast, the agency as a whole will 

be referred to, in this part, as the CPSC. 

CPSA: We would define this acronym 

to mean the Consumer Product Safety 

Act, 15 U.S.C. 2051–2089. 

Notice of requirements: We would 

define this term consistent with how it 

is used in section 14 of the CPSA and 

with how we have used the term to date. 

It would mean a publication that 

provides the minimum qualifications 

necessary for a laboratory to become 

CPSC-accepted to test children’s 

products pursuant to a particular 

children’s product safety rule. 

Scope: The testing and accreditation 

community typically use the word 

‘‘scope’’ or ‘‘scope of accreditation’’ to 

mean the entire list of testing services 

for which a laboratory has been granted 

accreditation, which usually includes 

many test methods and standards 

beyond those related to CPSC rules. For 

purposes of this part, we would define 

this term slightly differently. In part 

1112, ‘‘scope’’ would mean the range of 

particular children’s product safety 

rules and/or test methods to which a 

laboratory has been accredited and for 

which it may apply for CPSC acceptance 

of its accreditation. 

Suspend: The proposed rule would 

define this term consistent with its use 

in section 14(e) of the CPSA, which this 

proposed rule would implement. 

‘‘Suspend’’ would mean that the CPSC 

has removed its acceptance, for 

purposes of the testing of children’s 

products required in section 14 of the 

CPSA, of a laboratory’s accreditation 

due to the laboratory’s failure to 

cooperate in an investigation under this 

part. 

Third party conformity assessment 

body: We propose to define this term to 

mean a testing laboratory. 

We developed this definition from the 

use of the term ‘‘third party conformity 

assessment body’’ in section 14 of the 

CPSA. The CPSA contains a lengthy 

definition of this term, which includes 

the conditions placed on governmental 

and firewalled laboratories. For ease of 

understanding, we propose to define the 

term more succinctly, but our definition 

is consistent with the term’s use 

throughout the CPSA. 

In particular, we note that the 

statutory definition of this term states 

that a governmental laboratory that 

satisfies certain conditions may be 

considered a third party conformity 

assessment body. The statutory 

definition also states that a conformity 

assessment body that is owned, 

managed, or controlled by a 

manufacturer or private labeler may be 

accepted as a third party conformity 

assessment body by the Commission if 

it satisfies certain conditions. Section 14 

of the CPSA consistently refers to CPSCaccepted laboratories collectively as 

‘‘third party conformity assessment 

bodies.’’ 

We are aware that the term ‘‘third 

party conformity assessment body,’’ by 

virtue of the words ‘‘third party,’’ 

commonly refers to a laboratory that is 

entirely independent of the entity 

supplying the product to be tested and 

independent of any entity interested in 

the product. However, because this rule 

implements section 14 of the CPSA, 

which refers to all CPSC-accepted 

laboratories as ‘‘third party conformity 

assessment bodies,’’ the proposed rule 

would follow the statute’s convention 

on this point. 

We also are aware that, in the 

laboratory industry, the term ‘‘third 

party conformity assessment body’’ is 

understood to include entities other 

than testing laboratories. However, the 

proposed rule would use the term as it 

is used in the CPSA, which is as a 

testing laboratory. 

Finally, we note that, in the preamble 

to this rule, for ease of reference, and for 

the convenience of the reader, we use 

the word ‘‘laboratory’’ interchangeably 

with ‘‘third party conformity assessment 

body.’’ In the regulatory text, for clarity, 

we only use the full term, ‘‘third party 

conformity assessment body.’’ 

Undue influence: We have developed 

a definition for undue influence after 

reviewing similar definitions used by 

other federal agencies and some 

laboratories, and with the goal of having 

a broad enough definition that the 

myriad sources and methods of undue 

influence that could arise in this context 

would be captured by the definition. 

The proposed rule would define ‘‘undue 

influence’’ to mean that a manufacturer, 

private labeler, governmental entity, or 

other interested party affects a 

laboratory, such that commercial, 

financial, and other pressures 

compromise the integrity of its testing 

processes or results. 

Withdraw: The proposed rule would 

define this term consistent with its use 

in section 14(e) of the CPSA. The 

proposal would define ‘‘withdraw’’ to 

mean that the CPSC removes its prior 

acceptance of a laboratory’s 

accreditation pursuant to a particular 

children’s product safety rule for 

purposes of the testing of children’s 

products required in section 14 of the 

CPSA. 

B. Subpart B—General Requirements 

Pertaining to Third Party Conformity 

Assessment Bodies 

Proposed subpart B would establish 

the foundation for the CPSC third party 

conformity assessment body program 

with respect to basic topics, such as 

when and how a laboratory may apply 

to the CPSC for acceptance of its 

accreditation, and how a laboratory can 

voluntarily discontinue its participation 

with the CPSC. The proposed subpart 

also would define the three types of 

laboratories, create various obligations 

for CPSC-accepted laboratories, such as 

recordkeeping responsibilities, and 

institute certain limitations, such as 

limits on the ability to subcontract test 

work conducted, on CPSC-accepted 

laboratories. Proposed subpart B also 

would include details on how we will 

respond to each application and how we 

will publish information concerning 

which laboratories have had their 

accreditation accepted. 

1. Proposed § 1112.11—What are the 

types of third party conformity 

assessment bodies? 

Proposed § 1112.11 would describe, 

for purposes of part 1112, the three 

types of third party conformity 

assessment bodies: Independent, 

firewalled, and governmental. Proposed 

§ 1112.11(a) would describe an 

‘‘independent laboratory’’ as a third 

party conformity assessment body that 

is neither owned, managed, or 

controlled by a manufacturer or private 

labeler of a children’s product to be 

tested by the laboratory, nor owned or 

controlled, in whole or in part, by a 

government. 

Section 14(f)(2) of the CPSA defines a 

‘‘firewalled third party conformity 

assessment body’’ as one that is owned, 

managed, or controlled by a 

manufacturer or private labeler. We note 

that section 14(f)(2)(D) of the CPSA 

clearly states that a firewalled laboratory 

is one ‘‘owned, managed, or controlled 

by a manufacturer or private labeler 

(emphasis added).’’ Therefore, we do 

not consider a laboratory to be 

firewalled if the laboratory owns, 

manages, or controls a manufacturer or 

private labeler. 

We note that, for purposes of 

determining whether a laboratory is 

considered firewalled, we propose to 

interpret ‘‘manufacturer’’ to include a 

trade association. Like a manufacturer, 

an association of manufacturers is in a 

position to exert undue influence on a 

laboratory owned, managed, or 

controlled by the association. The 

undue influence may come in the form 

of an expectation that special 


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31110 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

consideration will be given to the test 

results of association members or 

reports of attempted undue influence by 

an association member are discouraged. 

The proposed rule would consider a 

laboratory ‘‘firewalled’’ if: it is owned, 

managed, or controlled by a 

manufacturer or private labeler of a 

children’s product; that children’s 

product is subject to a CPSC children’s 

product safety rule which the laboratory 

requests CPSC acceptance to test; and 

the laboratory intends to test such 

children’s product made by the owning, 

managing, or controlling entity for the 

purpose of supporting a Children’s 

Product Certificate. A laboratory would 

be considered to be ‘‘owned, managed, 

or controlled’’ by a manufacturer or 

private labeler if one (or more) of four 

characteristics apply. 

The first circumstance that would 

result in a laboratory being 

characterized as firewalled is closely 

related to the method we have been 

using in the notices of requirements to 

identify firewalled laboratories. Under 

proposed § 1112.11(b)(1)(ii)(A), if the 

manufacturer or private labeler of the 

children’s product holds a 10 percent or 

greater ownership interest, whether 

direct or indirect, in the laboratory, the 

laboratory would be considered 

firewalled. In this context, indirect 

ownership interest would be calculated 

by successive multiplication of the 

ownership percentages for each link in 

the ownership chain. 

We propose to maintain the 10 

percent threshold ownership amount 

because it is our estimation that a 

manufacturer or private labeler that 

possesses a less than 10 percent 

ownership interest in a laboratory, and 

that does not otherwise exercise 

management or control of the 

laboratory, presents a low risk of 

exercising undue influence over the 

laboratory. In addition, our experience 

using this threshold over the past three 

years indicates that applicants easily 

understand it and have been able to 

supply such information. We note that 

the Federal Communications 

Commission also uses a 10 percent 

ownership threshold in its ownership 

disclosure requirements for 

applications. See 47 CFR 1.2112. 

The difference in the proposed rule 

from current practice is the addition of 

indirect ownership. Proposed 

§ 1112.11(b)(1)(ii)(A) would include 

indirect ownership because an entity 

that owns a manufacturer or private 

labeler which, in turn, owns a 

laboratory, has the same potential for 

conflict of interest concerning the 

independence of the testing process as 

a manufacturer or private labeler who 

owns a laboratory directly. We propose 

to determine whether an indirect owner 

holds a 10 percent interest in a 

laboratory by multiplying the 

percentages of ownership in each 

owning entity. For example, if Company 

X is a manufacturer of a children’s 

product and owns 25 percent of the 

stock in Company Y, and Company Y 

owns 50 percent of Laboratory Z, then 

Company X would own (indirectly) 12.5 

percent of Laboratory Z (0.25 × 0.50 = 

0.125). Because Company X holds more 

than a 10 percent indirect ownership 

interest in Laboratory Z, if Laboratory Z 

wishes to apply to the CPSC for 

acceptance of its accreditation to test 

children’s products made by Company 

X, Laboratory Z would be considered an 

applicant for firewalled status. This 

approach to calculating indirect 

ownership is used by some other 

Federal agencies. See, e.g., 42 CFR 

420.202 (Medicare regulations 

concerning ownership or control 

disclosure requirements); 47 CFR 1.2112 

(FCC regulations concerning ownership 

disclosure requirements). 

The second circumstance, in 

proposed § 1112.11(b)(1)(ii)(B), that 

would signify a firewalled laboratory is 

when the laboratory and a manufacturer 

or private labeler of the children’s 

product are owned by the same parent 

entity. In this instance, the 

manufacturer would not be a 10 percent 

owner of the laboratory, either directly 

or indirectly; but the interests of both 

entities would converge in a common 

parent. In such a case, the parent 

company would hold the interests of the 

manufacturer, and the laboratory should 

be properly firewalled to ensure its 

testing processes are independent. 

The third circumstance, in proposed 

§ 1112.11(b)(1)(ii)(C), which would 

result in firewalled status is when a 

manufacturer or private labeler of the 

children’s product has the ability to 

appoint a majority of the laboratory’s 

senior internal governing body 

(including, but not limited to, a board of 

directors); the ability to appoint the 

presiding official (including, but not 

limited to, the chair or president) of the 

laboratory’s senior internal governing 

body; and/or the ability to hire, dismiss, 

or set the compensation level for 

laboratory personnel. The ability to 

appoint the president or a majority of 

the senior internal governing body, or to 

make personnel decisions, indicates 

management and/or control of the 

laboratory. 

The fourth circumstance, at proposed 

§ 1112.11(b)(1)(ii)(D), that would result 

in firewalled status is when the 

laboratory is under a contract to a 

manufacturer or private labeler of the 

children’s product and the contract 

explicitly limits the services the 

laboratory may perform for other 

customers and/or explicitly limits 

which or how many other entities may 

also be customers of the laboratory. In 

this instance, the terms of the contract 

would grant the manufacturer or private 

labeler such a significant interest in the 

work of the laboratory that the 

Commission would consider that 

interest to be controlling. 

To date, the list of CPSC-accepted 

laboratories maintained on the CPSC 

Web site has not indicated which 

laboratories have firewalled status. 

Because this proposed rule would 

expand the definition of ‘‘firewalled 

laboratory’’ to include laboratories not 

only owned, but also those managed or 

controlled by a manufacturer or private 

labeler, we invite comments on whether 

the Web site listing should include an 

indication of firewalled status. Do 

manufacturers looking for a laboratory 

via the CPSC Web site want to know 

whether a laboratory is firewalled? Are 

there other interests in identifying a 

laboratory as firewalled on our Web 

site? Do laboratories with firewalled 

status perceive disadvantages to being 

identified as such? 

According to section 14(f)(2)(B) of the 

CPSA, a ‘‘governmental’’ laboratory is 

one ‘‘owned or controlled in whole or 

in part by a government.’’ Proposed 

§ 1112.11(c) would implement that 

definition. For purposes of this part, we 

would consider ‘‘government’’ to 

include any unit of a national, 

territorial, provincial, regional, state, 

tribal, or local government. 

‘‘Government’’ would include domestic, 

as well as foreign governmental entities. 

Proposed § 1112.11(c) would consist 

of six characteristics, any one of which 

triggers governmental laboratory status. 

The legal framework for government 

ownership or control of a laboratory will 

vary across the world’s jurisdictions, as 

will the potential for undue influence as 

a direct or indirect result of that 

government’s ownership or control. The 

government of the laboratory in 

question may exercise control, based on 

the rule of law or otherwise, out of 

proportion to its ownership stake in a 

laboratory or to the laboratory’s official 

independent status within the 

government organizational structure—a 

situation that Congress foresaw when it 

specified ‘‘in whole or in part’’ in 

section 14(f)(2)(B) of the CPSA. For that 

reason, the proposed rule would 

describe those ways that a government 

could reasonably be seen to have a 

means of operational control over a 

laboratory that has a financial or 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31111 

organizational connection to that 

government. 

The first characteristic that would 

indicate governmental status is that a 

governmental entity holds a 1 percent or 

greater ownership interest, whether 

direct or indirect, in the laboratory. 

Selecting 1 percent as an ownership 

threshold is a practical matter of 

selecting the smallest whole number as 

an expression of ownership ‘‘in part.’’ 

Indirect ownership interest would be 

calculated for these purposes in the 

same way as we propose to calculate it 

for purposes of indirect ownership of a 

firewalled laboratory, which is by 

successive multiplication of the 

ownership percentages for each link in 

the ownership chain. For example, if 

Government A is a joint venture partner 

with Company B, such that Government 

A owns 20 percent of Company B, and 

Company B holds a 10 percent interest 

in Laboratory C, then Government A 

would indirectly own 2 percent of 

Laboratory C. Therefore, Laboratory C is 

considered a governmental laboratory. 

The second characteristic that would 

indicate governmental status is that a 

governmental entity provides any direct 

financial investment or funding (other 

than fee for work) to the laboratory. We 

consider that this circumstance would 

trigger governmental status because 

operational control of an enterprise may 

be affected by control or influence over 

its resources. 

The third proposed governmental 

characteristic would mirror the third 

characteristic of firewalled status: a 

governmental entity has the ability to 

appoint a majority of the laboratory’s 

senior internal governing body (such as 

but not limited to a board of directors); 

the ability to appoint the presiding 

official of the laboratory’s senior 

internal governing body (such as but not 

limited to chair or president); and/or the 

ability to hire, dismiss, or set the 

compensation level for laboratory 

personnel. The ability to appoint the 

president or a majority of the senior 

internal governing body, or to make 

personnel decisions, indicates control, 

at least in part, of the laboratory. 

The fourth characteristic, at proposed 

§ 1112.11(c)(4), would consider a 

laboratory to be governmental if any of 

the laboratory’s management or 

technical personnel are government 

employees. This direct involvement by 

the government in the operation of the 

laboratory would represent control in 

part. 

The fifth characteristic, at proposed 

§ 1112.11(c)(5), which would signify a 

governmental laboratory is if the 

laboratory has a subordinate position to 

a governmental entity in its external 

organizational structure. We would 

except the circumstance where the only 

relationship the laboratory has with the 

governmental entity is that of a 

regulated entity. In that sense, most 

laboratories in existence are associated 

administratively with a government, 

and we do not consider the existence of 

governmental regulations applicable to a 

laboratory to establish governmental 

control. (For example, the fact that a 

laboratory may be subject to certain 

employment requirements or subject to 

tax regulations does not establish that 

the laboratory is a government 

laboratory.) Instead, we intend to 

consider those laboratories that are 

organizationally a part of, or formally 

linked to, the government to be 

governmental laboratories. In those 

cases, even if the government is not an 

owner, it has the means of controlling 

the laboratory. 

Finally, the sixth characteristic, at 

proposed § 1112.11(c)(6), would list 

situations in which government control 

of a laboratory is evident via the 

authority the government has over the 

laboratory. We propose that if a 

government can determine, establish, 

alter, or otherwise affect the laboratory’s 

testing outcomes, its budget or financial 

decisions, its organizational structure or 

continued existence, or whether the 

laboratory may accept particular offers 

of work, then the laboratory would be 

considered governmental. 

2. Proposed § 1112.13—How does a 

third party conformity assessment body 

apply for CPSC acceptance? 

Proposed § 1112.13 would describe 

how a third party conformity 

assessment body may apply for CPSC 

acceptance of its accreditation. We 

propose to use the authority granted in 

section 14(a)(3)(C) of the CPSA to 

designate signatories to the ILAC–MRA 

to accredit laboratories to ISO/IEC 

17025:2005. For a laboratory to be able 

to conduct tests under section 14 of the 

CPSA, however, the CPSC must 

affirmatively accept that laboratory’s 

accreditation. 

Proposed § 1112.13(a) would relate 

the initial baseline requirements 

applicable to all laboratory applicants. 

The proposed baseline requirements are 

substantially similar to the baseline 

requirements in the notices of 

requirements, although the application 

form (CPSC Form 223) would be revised 

to correspond with other changes in the 

proposed rule. The first baseline 

requirement would be a completed 

application, CPSC Form 223. On a 

revised CPSC Form 223, the laboratory 

would attest to certain facts and 

characteristics concerning its business, 

which would determine whether the 

applicant is independent, firewalled, or 

governmental. If the laboratory is 

considered firewalled or governmental, 

the online CPSC Form 223 will prompt 

the laboratory to submit the requisite 

additional documentation. On a revised 

CPSC Form 223, the laboratory also 

would attest that it has read, 

understood, and agrees to the 

regulations in this part. Proposed 

§ 1112.13(a) also would require that the 

laboratory update its CPSC Form 223 

whenever any information previously 

supplied on the form changes. 

The second baseline criteria would be 

an accreditation certificate. Each 

laboratory would be required to be 

accredited to ISO/IEC Standard 

17025:2005, ‘‘General requirements for 

the competence of testing and 

calibration laboratories.’’ Because we 

are proposing to require compliance 

with a standard that is already 

published, we must incorporate that 

standard by reference into these 

regulations. The proposed rule would 

note that the Director of the Federal 

Register approved the incorporation by 

reference of ISO/IEC 17025:2005 in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51. It would note that readers 

may obtain a copy of ISO/IEC 

17025:2005 from the International 

Organization for Standardization (ISO), 

1, ch. de la Voie-Creuse, Case postale 

56, CH–1211 Geneva 20, Switzerland; 

Telephone +41 22 749 01 11, Fax +41 

22 733 34 30; http://www.iso.org/iso/ 

catalogue_detail.htm?csnumber=39883. 

Readers may also inspect a copy at the 

Office of the Secretary, U.S. Consumer 

Product Safety Commission, Room 820, 

4330 East West Highway, Bethesda, MD 

20814, telephone 301–504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741– 6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

The proposed rule would require 

accreditation by an accreditation body 

that is a signatory to the ILAC–MRA. All 

laboratories also would be required to 

furnish their statement of scope, and it 

would have to clearly identify the CPSC 

rule(s) and/or test method(s) for which 

CPSC acceptance is sought. 

Proposed § 1112.13(b) would state the 

additional requirements for firewalled 

laboratories. Section 14(f)(2)(D) of the 

CPSA mandates that a laboratory only 

may be accepted as firewalled if the 

Commission, by order, finds that: 


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31112 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

(i) [Acceptance] of the conformity 

assessment body would provide equal or 

greater consumer safety protection than the 

manufacturer’s or private labeler’s use of an 

independent third party conformity 

assessment body; and 

(ii) [T]he conformity assessment body has 

established procedures to ensure that— 

(I) [I]ts test results are protected from 

undue influence by the manufacturer, private 

labeler, or other interested party; 

(II) [T]he Commission is notified 

immediately of any attempt by the 

manufacturer, private labeler or other 

interested party to hide or exert undue 

influence over test results; and 

(III) [A]llegations of undue influence may 

be reported confidentially to the 

Commission. 

15 U.S.C. 2063(f)(2)(D). 

To evaluate whether a laboratory 

satisfies these criteria, the proposed rule 

would require that a laboratory seeking 

CPSC-accepted firewalled status submit 

copies of various documents to the 

CPSC. First, the proposed rule would 

require the laboratory to submit copies 

of certain established policies and 

procedures. The laboratory would need 

to submit its policies and procedures 

that explain how test results are 

protected from undue influence by the 

manufacturer, private labeler, or other 

interested party. The purpose of 

reviewing such documents would be to 

assess whether the laboratory has 

established the necessary written 

procedures to preserve its independence 

from the manufacturer or private 

labeler. We also would require the 

laboratory to submit copies of 

established policies and procedures, 

indicating that the CPSC will be notified 

immediately of any attempt to hide or 

exert undue influence over test results, 

and policies and procedures explaining 

that an allegation of undue influence 

may be reported confidentially to the 

CPSC. The purpose of reviewing these 

documents is to ensure that the 

laboratory has written procedures in 

place that address when and how the 

CPSC will be notified of any attempt at 

undue influence. 

Second, the proposed rule would 

require an applicant laboratory seeking 

firewalled status to supply copies of 

training documents, including a 

description of the training program 

content, showing how employees are 

trained on the three policies just 

described. We propose to require this 

training annually. If an employee 

receives such training only once, the 

employee may forget the information 

over the course of time, or the 

importance of the information would 

not be reinforced. In addition, the issue 

of staff turnover presents a risk that new 

employees would not receive the 

training. An annual training 

requirement would address these risks. 

Third, proposed § 1112.13(b)(2) 

would require training records listing 

the staff members who received the 

training and bearing their signatures. 

The training records would include 

training dates, location, and the name 

and title of the individual providing the 

training. We propose to require the 

submission of these training-related 

documents so that we may assess 

whether the laboratory is sufficiently 

and effectively communicating to its 

employees the need to protect the 

testing process from undue influence, 

and that the employees may notify the 

CPSC immediately and confidentially of 

any attempt by a manufacturer, private 

labeler, or other interested party to hide 

or exert undue influence over test 

results. 

Proposed § 1112.13(b)(2)(iv) and (v) 

would require firewalled laboratory 

applicants to submit two organizational 

charts. One chart would be an 

organizational chart(s) of the laboratory 

itself. It would include the names of all 

personnel, both temporary and 

permanent, and their reporting 

relationship within the laboratory. The 

other organizational chart would 

identify the reporting relationships of 

the laboratory within the broader 

organization (using both position titles 

and staff names). Finally, we also would 

require a list of all laboratory personnel 

with reporting relationships outside of 

the laboratory. The list would identify 

the name and title of the relevant 

laboratory employee(s) and the names, 

titles, and employer(s) of all individuals 

outside of the laboratory to whom they 

report. The organizational charts and 

the list of employees with outside 

reporting relationships would help us 

determine the degree to which the 

laboratory is independent of the 

manufacturer or private labeler. 

If the Commission determines that the 

firewalled-specific documents indicate 

that the laboratory has sufficient 

safeguards against and procedures 

concerning undue influence in place, 

and the laboratory satisfies the baseline 

criteria, including ISO/IEC 17025:2005 

accreditation by an ILAC–MRA 

signatory body, then the Commission 

will consider that the applicant 

laboratory would provide equal 

consumer safety protection than the 

manufacturer’s or private labeler’s use 

of an independent laboratory. 

Proposed § 1112.13(c) would state the 

additional accreditation requirements 

applicable to governmental laboratories. 

Section 14(f)(2)(B) of the CPSA 

mandates that the Commission may 

accept the accreditation of a 

governmental laboratory if: 

(i) [T]o 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) [T]he entity’s testing results are not 

subject to undue influence by any other 

person, including another governmental 

entity; 

(iii) [T]he entity is not accorded more 

favorable treatment than other third party 

conformity assessment bodies in the same 

nation who have been accredited under 

[section 14]; 

(iv) [T]he entity’s testing results are 

accorded no greater weight by other 

governmental authorities than those of other 

accredited third party conformity assessment 

bodies accredited under [section 14]; and 

(v) [T]he 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). 

To evaluate whether a laboratory 

satisfies these criteria, the proposed rule 

would require a governmental 

laboratory to submit a description that 

can be in the form of a diagram, which 

illustrates relationships with other 

entities, such as government agencies 

and joint venture partners. Such a 

document would give us basic 

information concerning the nature of the 

relationship between the laboratory and 

the government. In addition, we would 

require the laboratory and the relevant 

governmental entity to each respond to 

a questionnaire. The questionnaires are 

designed to elicit information related to 

the five statutory criteria. 

Third, we would require a 

governmental laboratory to submit a 

copy of an executed memorandum that 

addresses undue influence. The purpose 

of the memorandum is to provide 

affirmative and continuous 

communication to the laboratory staff 

concerning the management policies 

regarding undue influence, and the 

staff’s responsibilities in implementing 

the policies. The memorandum would 

be on company letterhead, from the 

senior management of the laboratory, 

and directed to all laboratory staff. The 

memorandum must be in the primary 

written language used for business 

communications in the area in which 

the laboratory is located, and, if that 

language is not English, then the 

laboratory must provide an English 

translation. The memorandum would 

need to be displayed prominently at the 

laboratory for as long as the laboratory 

is accepted by the CPSC. 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31113 

The proposed rule would require the 

memorandum to state certain policies. It 

would require that the memorandum 

state that the laboratory’s policy is to 

reject undue influence. We also would 

have the memorandum require 

employees to report immediately, to 

their supervisor or some other 

designated laboratory official, any 

attempt at undue influence. It would 

require the memorandum to state that 

the laboratory will not tolerate 

violations of the undue influence 

policy. 

The fourth and final document to be 

required from governmental laboratory 

applicants would be an attestation. We 

would require a senior official of the 

governmental laboratory, who has the 

authority to make binding statements of 

policy on behalf of the laboratory, to 

attest to several statements related to the 

application, including that the 

laboratory does not receive and will not 

accept favorable treatment from any 

governmental entity with regard to 

products for export to the United States 

that are subject to CPSC jurisdiction. 

Among other things, the senior official 

of the governmental laboratory would 

have to attest that the information in the 

laboratory’s application continues to be 

accurate, unless the laboratory notifies 

the CPSC otherwise. Thus, the senior 

official would be acknowledging a duty 

to inform the CPSC if any information 

submitted as part of the application has 

changed. As another example, the 

proposal would require the senior 

official to attest that the laboratory will 

not conduct CPSC tests in support of a 

Children’s Product Certificate for 

products produced by a governmental 

entity that has any ownership or control 

of the laboratory. The attestation gives 

us an additional level of assurance that 

is unique to intergovernmental 

relationships. 

Finally, the proposed rule would state 

that, if our approval of a governmental 

laboratory application is dependent 

upon a recently changed circumstance 

in the relationship between the 

laboratory and the governmental entity, 

and/or a recently changed policy of the 

related governmental entity, we may 

require the relevant governmental entity 

to attest to the details of the new 

relationship or policy. Such a provision 

would enable us to verify the changed 

circumstance prior to our acceptance of 

the governmental laboratory. 

Proposed § 1112.13(d) would state 

that if a laboratory satisfies both the 

criteria for governmental status and the 

criteria for firewalled status, such a 

laboratory would be required to apply 

under both categories. 

Proposed § 1112.13(e) would require 

that all application materials be in 

English. Proposed § 1112.13(f) would 

require that CPSC Form 223 and all 

required accompanying documentation 

be submitted electronically via the 

CPSC Web site. We have established an 

electronic application system accessed 

via our Internet site at: http:// 

www.cpsc.gov/about/cpsia/ 

labaccred.html. Proposed § 1112.13(g) 

would reserve the authority to require 

additional information from an 

applicant laboratory to determine 

whether the laboratory meets the 

relevant criteria. This provision would 

allow us to gather additional 

information if the initial information 

supplied by an applicant laboratory was 

insufficient. This paragraph also would 

state that we may, before acting on an 

application, verify the accreditation 

certificate and statement of scope 

directly from the accreditation body. 

Finally, proposed § 1112.13(h) would 

provide that a laboratory may retract an 

application at any time before the CPSC 

has acted on it. We would note, 

however, that a retraction would not 

end or nullify any enforcement action 

that the CPSC is authorized to pursue. 

3. Proposed § 1112.15—When can a 

third party assessment body apply for 

CPSC acceptance for a particular CPSC 

rule and/or test method? 

Proposed § 1112.15(a) would state, 

consistent with section 14(a)(3) of the 

CPSA, that a laboratory may apply to 

the CPSC for acceptance of its 

accreditation to test a children’s product 

to a particular CPSC rule and/or test 

method once the Commission has 

published the requirements for 

accreditation of third party conformity 

assessment bodies to assess conformity 

with that rule and/or test method. A 

laboratory would be able to apply for 

acceptance to more than one CPSC rule 

and/or test method at a time. 

Alternatively, a laboratory also would 

be able to apply separately for various 

CPSC rules and/or test methods. A 

laboratory would only be authorized to 

issue test results for purposes of section 

14 of the CPSA for tests that fall within 

the CPSC rules and/or test methods for 

which its accreditation has been 

accepted by the CPSC. 

Proposed § 1112.15(b) would list the 

rules and test methods for which the 

Commission has published the 

requirements for accreditation of 

laboratories. The list is current through 

August 10, 2011. When any final rule 

resulting from this proposed rule 

publishes, we intend to add to this list 

those CPSC rules and/or test methods 

for which we have published proposed 

requirements between October 1, 2011 

and the date of the final rule. After any 

final rule publishes, additions or 

revisions to this list would be proposed 

as amendments to this section. 

Some notices of requirements 

contained unique provisions related to 

exactly what a laboratory’s statement of 

scope must indicate for the CPSC to 

accept that accreditation. Those unique 

provisions are included in this list. 

In the Federal Register of September 

20, 2011, we published a proposed rule 

to establish a safety standard for play 

yards. See 76 FR 58167, (September 20, 

2011). The standard would be codified 

at 16 CFR part 1221. We are working on 

a final rule to establish a safety standard 

for play yards and hope to issue it in the 

near future. Consequently, proposed 

§ 1112.15(b)(7) would include 16 CFR 

part 1221 among the list of CPSC rules 

and/or test methods for accreditation for 

third party conformity assessment 

bodies. If, however, the Commission 

does not issue a final rule to establish 

a safety standard for play yards, we will 

revise § 1112.15(b) accordingly, as part 

of this rulemaking process. 

In the Federal Register of February 

10, 2012, we published a proposed rule 

to establish a safety standard for infant 

swings. See 77 FR 7011, (February 10, 

2012). The standard would be codified 

at 16 CFR part 1223. We are working on 

a final rule to establish a safety standard 

for infant swings and hope to issue it in 

the near future. Consequently, proposed 

§ 1112.15(b)(8) would include 16 CFR 

part 1223 among the list of CPSC rules 

and/or test methods for accreditation for 

third party conformity assessment 

bodies. If, however, the Commission 

does not issue a final rule to establish 

a safety standard for infant swings, we 

will revise § 1112.15(b) accordingly, as 

part of this rulemaking process. 

We have included the notice of 

requirements for the safety standard for 

portable bedrails at proposed 

§ 1112.15(b)(9) in the list because we 

have published a final rule establishing 

the safety standard for bed rails (16 CFR 

part 1224) in the Federal Register. See 

77 FR 12182 (February 29, 2012). 

We will accept retrospective testing 

for 16 CFR part 1224 under certain 

circumstances. For the tests contained 

in 16 CFR part 1224, testing before the 

effective date of 16 CFR part 1112 will 

be accepted, if the following conditions 

are met: 

• The children’s product was tested 

by a third party conformity assessment 

body accredited to ISO/IEC 17025:2005 

by a signatory to the ILAC–MRA at the 

time of the test. The scope of the third 

party conformity body accreditation 

must include testing in accordance with 


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31114 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

16 CFR part 1224. For firewalled third 

party conformity assessment bodies, the 

firewalled third party conformity 

assessment body must be one that the 

Commission, by order, has accredited 

on or before the time that the children’s 

product was tested, even if the order did 

not include the tests contained in 16 

CFR part 1224. For governmental third 

party conformity assessment bodies, the 

governmental third party conformity 

assessment body must be one whose 

accreditation was accepted by the 

Commission, even if the scope of 

accreditation did not include the tests 

contained in 16 CFR part 1224. 

• The third party conformity 

assessment body’s application for 

acceptance of its accreditation is 

accepted by the CPSC on or after May 

24, 2012 and before the effective date of 

16 CFR part 1112. 

• The test results show compliance 

with 16 CFR part 1224. 

• The children’s product was tested 

on or after the date of publication in the 

Federal Register of the final rule for 16 

CFR part 1224, and before the effective 

date of 16 CFR part 1112. 

• The testing laboratory’s 

accreditation remains in effect through 

the effective date of 16 CFR part 1112. 

Additionally, the notice of 

requirements pertaining to 16 CFR part 

1303, Ban of Lead-Containing Paint and 

Certain Consumer Products Bearing 

Lead-Containing Paint, is listed at 

proposed § 1112.15(b)(10). According to 

our initial notice of requirements for 

part 1303 (73 FR 54564 (Sept. 22, 

2008)), in order for us to accept a 

laboratory to test children’s products for 

conformity with the lead-paint ban, the 

laboratory’s scope of accreditation had 

to include 16 CFR part 1303 (73 FR 

54565). Part 1303 does not contain a test 

method. We received comments from 

the public, asking us to specify test 

methods to ensure that accreditation 

bodies are able to determine the 

acceptable technologies and methods for 

lead analyses. On April 5, 2011, we 

published a revision to the notice of 

requirements for part 1303 to specify 

particular test methods, one or more of 

which laboratories must have in their 

scope of accreditation in order for us to 

accept their accreditation to test for 

conformity with the lead paint ban. 

Proposed § 1112.15(b)(10) would list 

the approved test methods for 16 CFR 

part 1303, ‘‘Ban of Lead-Containing 

Paint and Certain Consumer Products 

Bearing Lead-Containing Paint’’ and 

require a third party conformity 

assessment body to reference one or 

more of the approved test methods in its 

statement of scope: 

• CPSC Standard Operating 

Procedure for Determining Lead (Pb) in 

Paint and Other Similar Surface 

Coatings, CPSC–CH–E1003–09 and/or 

CPSC–CH–E1003–09.1; 

• ASTM F 2853–10, ‘‘Standard Test 

Method for Determination of Lead in 

Paint Layers and Similar Coatings or in 

Substrates and Homogenous Materials 

by Energy Dispersive X–Ray 

Fluorescence Spectrometry Using 

Multiple Monochromatic Excitation 

Beams.’’ 

The original notice of requirements 

pertaining to 16 CFR part 1303 did not 

require reference to any particular test 

method. See 73 FR 54564 (Sept. 22, 

2008). In order to give third party 

conformity assessment bodies sufficient 

time to amend their scope of 

accreditation to include one or more of 

the test methods listed in proposed 

§ 1112.15 (b)(10): 

• Third party conformity assessment 

bodies that were listed on the CPSC’s 

Web site as accepted to 16 CFR part 

1303 on April 5, 2011 (the date when 

the CPSC published the revision to the 

notice of requirements in the Federal 

Register, see 76 FR 18646) have until 

April 5, 2013, to reapply and be 

accepted by the Commission with an 

statement of scope that includes one or 

more of the test methods listed in 

proposed § 1112.15(b)(10); 

• Third party conformity assessment 

bodies that were not listed on the CPSC 

Web site as accepted to 16 CFR part 

1303 on April 5, 2011, and apply for 

acceptance to 16 CFR part 1303 on or 

before April 5, 2012, have the option to 

apply without reference to one or more 

of the test methods listed in proposed 

§ 1112.15(b)(10); 

• Third party conformity assessment 

bodies that were not listed on the CPSC 

Web site as accepted to 16 CFR part 

1303 on April 5, 2011, and apply for 

acceptance after April 5, 2012, must 

have one or more of the test methods 

listed in proposed § 1112.15(b)(10) on 

their statement of scope. 

Proposed § 1112.15(b)(11) would 

reference 16 CFR part 1420, Safety 

Standard for All-Terrain Vehicles. We 

note that recently, we published a final 

rule in the Federal Register, revising 16 

CFR part 1420. See 77 FR 12197 

(February 29, 2012). The final rule 

makes American National Standard, 

ANSI/SVIA–1–2010, the new mandatory 

standard for ATVs, and the new 

standard is effective April 30, 2012, 

replacing the previous standard, which 

was designated ANSI/SVIA–1–2007. For 

purposes of testing youth ATVs, 

however, ANSI/SVIA 1–2010 is 

functionally equivalent to ANSI/SVIA 

1–2007 because the changes specified in 

the 2010 edition do not substantially 

change the requirements applicable to, 

nor do they affect the associated 

conformance testing of youth ATVs. 

Consequently, the Commission is 

continuing its acceptance of 

accreditation of the third party 

conformity assessment body to test 

youth ATVs. (As of February 7, 2012, 

we had accepted the accreditation of a 

single third party conformity assessment 

body to test youth ATVs.) Thus, the 

third party conformity assessment body 

should test youth ATVs for compliance 

with ANSI/SVIA 1–2010, as 

incorporated by reference in 16 CFR 

part 1420. Based on such testing, 

manufacturers of youth ATVs should 

issue certificates under section 14(a)(2) 

of the CPSA. 

Third party conformity assessment 

bodies that are accredited to test youth 

ATVs to the 2007 version of the ATV 

standard for children’s product 

certification purposes do not need to 

become reaccredited to the 2010 

revision before the next time their 

accreditation body reassesses them to 

the ATV standard. However, they may 

elect to do so. Third party conformity 

assessment bodies, whose accreditation 

to test to the 2007 version of the ATV 

standard has previously been accepted 

by the CPSC, must be accredited to the 

2010 revision of the ATV standard when 

reassessed by their accreditation body, 

and submit a Form 223 with the 

applicable accompanying documents to 

the CPSC in order to continue to have 

their accreditation to the ATV standard 

accepted. We will revise our listing of 

the third party conformity assessment 

body when it becomes accredited to the 

ATV standard and the CPSC accepts 

their application for accreditation. 

For third party conformity assessment 

bodies that applied for CPSC acceptance 

of accreditation to the 2007 version of 

the ATV standard before we accepted 

the 2010 revision of the ATV standard 

as a mandatory standard, and the CPSC 

accepts that accreditation, test results 

from the third party conformity 

assessment body can be used for 

children’s product certification 

purposes until the third party 

conformity assessment body is 

reassessed by its accreditation body to 

the ATV standard. If the third party 

conformity assessment body wishes to 

have its accreditation continue to be 

accepted by the CPSC after it is 

reassessed by its accreditation body, it 

must become accredited to the 2010 

revision of the standard and submit a 

new Form 223 with accompanying 

documents to the CPSC, requesting 

acceptance of its accreditation to the 

2010 revision of the standard. 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31115 

New third party conformity 

assessment body applicants that apply 

for CPSC acceptance on or after May 24, 

2012 must be accredited to the 2010 

revision when applying for CPSC 

acceptance of their accreditation to test 

youth ATVs. 

We also note four revisions to our 

lead-content test methods. Proposed 

§ 1112.15(b)(28) and (29), Lead Content 

in Children’s Metal Jewelry and Limits 

on Total Lead in Children’s Products: 

Children’s Metal Products, would 

contain two proposed revisions. First, 

the notices of requirements related to 

testing for lead content in children’s 

metal jewelry (73 FR 78331 (Dec. 22, 

2008)) and total lead in children’s 

products (74 FR 55821 (Oct. 29, 2009)) 

each listed the test method numbered 

CPSC–CH–E1001–08 as the required test 

method for testing for lead in children’s 

metal products (including metal 

jewelry). We revised that test method in 

June 2010. The revised method allows 

for some alternative, simplified 

procedures for certain portions of the 

test method. Second, we propose 

allowing the use of XRF spectrometry to 

determine the lead content in certain 

metals. The option of using the revised 

test methods would be reflected in 

proposed § 1112.15(b)(28) and (29). 

Accordingly, the proposed rule would 

provide that, to be considered for CPSCacceptance of accreditation to test for 

lead in children’s metal products 

(including metal jewelry), an applicant 

laboratory may have either Test Method 

CPSC–CH–E1001–08 (the original test 

method) and/or Test Method CPSC–CH– 

E1001–08.1 (the revised test method 

allowing alternative, simplified 

procedures) and/or the proposed 

revision of the test method, Test Method 

CPSC–CH–E1001–08.2 (allowing the use 

of XRF for certain metals) in its scope 

of accreditation. 

Third, proposed § 1112.15(b)(30), 

Limits on Total Lead in Children’s 

Products: Non-Metal Children’s 

Products, also would contain a 

proposed revision relative to the 

original notice of requirements. The 

notice of requirements related to testing 

for total lead in children’s products (74 

FR 55821 (Oct. 29, 2009)) listed the test 

method numbered CPSC–CH–E1002–08 

as the required test method for testing 

for lead in non-metal children’s 

products. We revised that test method in 

June 2010; the revised method allows 

for some alternative, simplified 

procedures for certain portions of the 

test method. Fourth, we propose 

allowing the use of XRF to determine 

the lead content in glass materials and 

crystals. This option would be reflected 

in proposed § 1112.15(b)(30). 

Accordingly, the proposed rule would 

state that, to be considered for CPSC 

acceptance of accreditation to test for 

lead in non-metal children’s products, 

an applicant laboratory may have Test 

Method CPSC–CH–E1002–08 (the 

original test method) and/or Test 

Method CPSC–CH–E1002–08.1 (the 

revised test method allowing 

alternative, simplified procedures) and/ 

or Test Method CPSC–CH–E1002–08.2 

(allowing the use of XRF for glass 

materials and crystals) in its scope of 

accreditation. 

We have identified a potential 

opportunity to reduce the testing 

burdens for certification of conformity 

related to the new requirements in 

ASTM F 963–11. Among the changes in 

ASTM F 963–11, are changes in the 

requirements and test methods for eight 

elements of interest: antimony, arsenic, 

barium, cadmium, chromium, lead, 

mercury, and selenium. ASTM F 963–11 

extends the requirements from prior 

versions (which had limits for these 

elements in surface coatings) to 

consider, in addition, these elements in 

substrates. For substrates and surface 

coatings, ASTM F 963–11 limits soluble 

migration of each of these elements 

when tested in dilute acid. 

Additionally, a new optional screening 

test is established in section 8.3.1 ASTM 

F 963–11, which is based on the total 

concentration of those elements, 

determined by digesting the samples 

completely, in hot, concentrated, strong 

acids, using methods based on CPSC 

test methods for lead content. 

ASTM F 963–11 allows the screening 

test from section 8.3.1 to be performed 

on a toy to establish that the total 

concentration of each of the eight 

elements of interest is lower than each 

of the soluble limits for those elements. 

For example, a toy that has only 10 ppm 

of each of those elements could not 

possibly leach more than the soluble 

limits for any of the elements (which are 

all greater than 10 ppm); and thus, the 

solubility test could be skipped. In 

another example, a toy that contained 

2,000 ppm barium would not pass the 

screening test for barium and would 

require solubility testing according to 

section 8.3 to determine how much 

barium would leach out (compared to 

the limit of 1,000 ppm soluble barium). 

We recognize that firms potentially 

could reduce testing costs if a single test 

would meet the screening test of section 

8.3.1 of ASTM F 963–11 and the CPSIA 

lead content requirements for paint, 

metals, or nonmetals. The methods 

provided in section 8.3.1 of ASTM F 

961–11 refer to CPSC test methods, but 

with a prescribed modification. The 

CPSC test methods for lead in paint 

(http://www.cpsc.gov/about/cpsia/ 

CPSC-CH-E1003-09_1.pdf), lead in 

nonmetals (http://www.cpsc.gov/about/ 

cpsia/CPSC-CH-E1002-08_1.pdf), and 

lead in metals (http://www.cpsc.gov/ 

about/cpsia/CPSC-CH-E1001-08_1.pdf) 

each allow for modifications based on 

sound chemical judgment and 

knowledge. CPSC staff tested a variety 

of well-characterized paint, metal, and 

nonmetal materials, and based upon the 

results and our professional judgment 

and experience, we found that the 

modifications detailed in section 8.3.1.2 

of ASTM F 963–11 represent sound 

chemical judgment to improve the 

recovery of antimony in certain 

samples. In addition, we believe that 

they are acceptable for use for lead in 

paint, lead in metals, and lead in 

nonmetals and are considered to be 

within the existing scope of allowable 

changes to the CPSC methods. Because 

these modifications are considered 

acceptable, a CPSC-accepted testing 

laboratory accredited to the CPSC 

method for lead in paint, CPSC–CH– 

E1003–09, for example, could test the 

paint from a toy, according to CPSC– 

CH–E1003–09, with the modifications 

provided in section 8.3.1.2 of ASTM F 

963–11, and still fulfill the requirements 

of CPSC–CH–E1003–09 to certify lead 

content and use the same testing to 

determine the screening levels for the 

other elements of interest. Because 

samples that fail the screening may pass 

section 4.3.5 solubility limits, a testing 

laboratory must be accredited in ASTM 

F 963–11, Section 8.3 to have its test 

results used to demonstrate compliance 

with the limits given in section 4.3.5. In 

the example above, the testing for lead 

in paint, with the modifications, could 

be used to determine if the elements of 

interest pass the screening test and the 

toy can be certified to section 4.3.5, 

without additional testing; paints 

exceeding screening limits for any of the 

elements of interest would have to be 

tested according to section 8.3 for heavy 

element solubility. 

Proposed § 1112.15(b)(31) would 

reference the limits on phthalates in 

children’s toys and child care articles. 

The notice of requirements pertaining to 

phthalates approved of two test 

methods, at least one of which must be 

included in a laboratory’s accreditation 

scope document in order for us to 

accept the laboratory to test for the 

limits on phthalates, and both test 

methods are included in proposed 

§ 1112.15(b)(31). 

The notice of requirements pertaining 

to toys also contained unique provisions 

related to exactly what a laboratory’s 

statement of scope must indicate for the 

CPSC to accept that accreditation. 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
31116 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

Pursuant to section 106 of the CPSIA, 

the provisions of ASTM International’s 

(formerly the American Society for 

Testing and Materials) (‘‘ASTM’’) 

Standard Consumer Safety Specification 

for Toy Safety, F 963, are considered to 

be consumer product safety standards 

issued by the Commission. For reasons 

explained in the notice of requirements, 

see 76 FR 46598, 46599 through 46600 

(Aug. 3, 2011), only certain provisions 

of ASTM F 963 are subject to third party 

testing requirements. We will accept the 

accreditation of laboratories only to 

those sections of ASTM F 963 that are 

subject to third party testing 

requirements. The list of sections of 

ASTM F 963 for which laboratories may 

apply for CPSC acceptance, which must 

each be specifically referenced in the 

laboratories’ scope documents, was 

contained in the notice of requirements 

and is reproduced in proposed 

§ 1112.15(b)(32). 

Additionally, proposed 

§ 1112.15(b)(32) would reflect recent 

revisions to the ASTM F 963 standard. 

On February 15, 2012, the Commission, 

pursuant to section 106(g) of the CPSIA, 

accepted the revised toy standard 

(ASTM F 963–11) as a consumer 

product safety standard. 77 FR 10358, 

(February 22, 2012). ASTM F 963–11 is, 

in many ways, equivalent or 

functionally equivalent to ASTM F 963– 

08. For example, in the notice of 

requirements that we issued on August 

3, 2011, some 23 sections in ASTM F 

963–08 remain unchanged in ASTM F 

963–11, and another seven sections in 

ASTM F 963–11 are functionally 

equivalent to their earlier counterparts 

in ASTM F 963–08. (By ‘‘functionally 

equivalent,’’ we mean that the standards 

organization made certain changes in 

the revised standard compared to the 

earlier standard, but the changes are not 

substantial and do not affect the 

associated conformance testing.) 

Consequently, the Commission is 

continuing its acceptance of 

accreditation of third party conformity 

assessment bodies for those provisions 

in ASTM F 963–11 that are equivalent 

or functionally equivalent to their 

corresponding provisions in ASTM F 

963–08. The third party conformity 

assessment bodies should test toys for 

compliance with ASTM F 963–11, and 

based on such testing, manufacturers 

should issue certificates under section 

14(a)(2) of the CPSA. 

Third party conformity assessment 

bodies that are accredited to test to 

provisions of ASTM F 963–08 that are 

equivalent or functionally equivalent for 

children’s product certification 

purposes do not need to become 

reaccredited to the ASTM F 963–11 

revision before the next time their 

accreditation body reassesses them to 

ASTM F 963 toy standard. However, 

they may elect to do so. Third party 

conformity assessment bodies whose 

accreditation to test to ASTM F 963–08 

has previously been accepted by the 

CPSC must be accredited to the ASTM 

F 963–11 revision when reassessed by 

their accreditation body, and they must 

submit a Form 223 with the applicable 

accompanying documents to the CPSC 

in order to continue to have their 

accreditation to ASTM F 963–11 

accepted. We will revise our listing of 

the third party conformity assessment 

body when it becomes accredited to the 

ASTM F 963–11 standard and the CPSC 

accepts their application for 

accreditation. 

For third party conformity assessment 

bodies that applied for CPSC acceptance 

of accreditation to ASTM F 963–08 

before the Commission accepted ASTM 

F 963–11 as a mandatory standard, and 

before we accepted that accreditation, 

test results from the third party 

conformity assessment body for those 

provisions of ASTM F 963–08 that are 

equivalent or functionally equivalent to 

ASTM F 963–11, can be used for 

children’s product certification 

purposes until the third party 

conformity assessment body is 

reassessed by its accreditation body to 

the ASTM F 963 toy standard. If the 

third party conformity assessment body 

wishes to have its accreditation 

continue to be accepted by the CPSC 

after it is reassessed by its accreditation 

body, it must become accredited to the 

ASTM F 963–11 and submit a new Form 

223 with accompanying documents to 

the CPSC, requesting acceptance of its 

accreditation to the 2011 revision of the 

standard. 

New third party conformity 

assessment body applicants that apply 

for CPSC acceptance on or after May 24, 

2012 must be accredited to the ASTM F 

963–11 revision when applying for 

CPSC acceptance of their accreditation 

to test toys under ASTM F 963. 

ASTM F 963–11, however, did make 

substantial changes to certain provisions 

in ASTM F 963–08 or added new testing 

or requirements. These changes are seen 

in the following sections of ASTM F 

963–11: 

• Section 4.3.5.1(2), Surface Coating 

Materials—Soluble Test for Metals; 

• Section 4.3.5.2, Toy Substrate 

Materials; 

• Section 4.15, Stability and Overload 

Requirements; 

• Section 4.37, Yo-Yo Elastic Tether 

Toys; and 

• Section 4.39, Jaw Entrapment in 

Handles and Steering Wheels. 

Therefore, proposed § 1112.15(b)(32) 

would add section 4.3.5.1(2) from 

ASTM F 963–11, ‘‘Surface Coating 

Materials—Soluble Test for Metals,’’ 

and section 4.3.5.2, ‘‘Toy Substrate 

Materials,’’ to the list of provisions in 

ASTM F 963 that require third party 

testing. The proposed rule, like the 

earlier notice of requirements for ASTM 

F 963–08, would continue to list section 

4.15, ‘‘Stability and Overload 

Requirements,’’ section 4.37, ‘‘Yo-Yo 

Elastic Tether Toys,’’ and section 4.39, 

‘‘Jaw Entrapment in Handles and 

Steering Wheels’’; but third party 

conformity assessment bodies should 

understand that these sections in ASTM 

F 963–11 are not equivalent to ASTM F 

963–08. Furthermore, if we had 

accepted the third party conformity 

assessment body’s accreditation to 

sections 4.15, 4.37, or 4.39 of ASTM F 

963–08, the third party conformity 

assessment body should become 

accredited to, and apply for, CPSC 

acceptance for its accreditation under 

sections 4.15, 4.37, and 4.39 of ASTM 

F 963–11. 

Proposed § 1112.15(b)(32) would 

establish and codify those provisions of 

ASTM F 963–11 that would require 

accreditation and third party testing. 

However, we are aware that another 

revision to ASTM F 963 may occur (see 

http://news.consumerreports.org/baby/ 

2012/01/revised-toy-safety-standardsare-in-the-works.html. If after the 

proposed rule is published in the 

Federal Register, the Commission 

receives a revision to ASTM F 963–11 

from ASTM and subsequently accepts 

the revision, we will (assuming that we 

issue a final rule) revise § 1112.15(b)(32) 

in the final rule to reflect the most 

current version of ASTM F 963 

approved by the Commission in lieu of 

ASTM F 963–11. 

We will accept testing on children’s 

products conducted by a third party 

conformity assessment body accepted 

by the Commission for those sections of 

ASTM F 963–08 that are considered 

equivalent or functionally equivalent to 

ASTM F 963–11, as discussed above. 

For those tests in ASTM F 963–11 that 

have no equivalent or functionally 

equivalent test in ASTM F 963–08, 

testing before the effective date of 

ASTM F 963–11 will be accepted, if the 

following conditions are met: 

• The children’s product was tested 

by a third party conformity assessment 

body accredited to ISO/IEC 17025:2005 

by a signatory to the ILAC–MRA at the 

time of the test. The scope of the third 

party conformity assessment body 

accreditation must include the tests 

contained in the applicable 

nonequivalent section of ASTM F 963– 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31117 

11. For firewalled third party 

conformity assessment bodies, the 

firewalled third party conformity 

assessment body must be one that the 

Commission, by order, has accredited, 

on or before the time that the children’s 

product was tested, even if the order did 

not include the nonequivalent tests 

contained in ASTM F 963–11. For 

governmental third party conformity 

assessment bodies, the governmental 

third party conformity assessment body 

must be one whose accreditation was 

accepted by the Commission, even if the 

scope of accreditation did not include 

the tests for the nonequivalent tests 

contained in ASTM F 963–11. 

• The third party conformity 

assessment body’s application for 

acceptance of its accreditation is 

accepted by the CPSC on or after May 

24, 2012 and before the effective date for 

16 CFR part 1112. 

• The test results show compliance 

with the nonequivalent section(s) of 

ASTM F 963–11. 

• The children’s product was tested 

on or after February 22, 2012, and before 

the effective date of 16 CFR part 1112. 

• The third party conformity 

assessment body’s accreditation remains 

in effect through the effective date of 16 

CFR part 1112. 

4. Proposed § 1112.17—How will the 

CPSC respond to each application? 

Proposed § 1112.17 would establish 

the procedures related to CPSC action 

on a third party conformity assessment 

body’s application for CPSC acceptance 

of its accreditation. 

Proposed § 1112.17(a) would state 

that CPSC staff will review each 

application, and they may contact 

applicant laboratories with questions or 

to request submission of missing 

information. 

Proposed § 1112.17(b), consistent 

with section 14(f)(2)(D) of the CPSA, 

would state that an application from a 

firewalled laboratory will be accepted 

by order of the Commission, if the 

Commission makes certain findings that 

are required by the statute; the required 

findings are enumerated. We intend that 

CPSC staff will act on applications from 

independent and governmental 

laboratories, as long as such action is 

consistent with a proper delegation of 

authority from the Commission. 

Proposed § 1112.17(c) would state 

that the CPSC will communicate its 

decision on each application, in writing, 

to the applicant; the written decision 

may be by electronic mail. 

5. Proposed § 1112.19—How does the 

CPSC publish information identifying 

third party conformity assessment 

bodies that have been accepted? 

In accordance with section 14(a)(3)(E) 

of the CPSA, proposed § 1112.19 would 

provide that the CPSC will maintain on 

its Web site an up-to-date listing of third 

party conformity assessment bodies 

whose accreditations have been 

accepted, and the scope of each 

acceptance. We would update the listing 

regularly to account for changes of 

information and status, such as the 

addition of CPSC rules and/or test 

methods to a scope of accreditation; 

changes to accreditation certificates; or 

a new address. In addition, we propose 

to update the listing to indicate changes 

in status, such as if a laboratory 

voluntarily discontinues its 

participation with the CPSC, or if the 

CPSC suspends or withdraws our 

acceptance of the accreditation of a 

laboratory (which we discuss later in 

this document). 

6. Proposed § 1112.21—May a third 

party conformity assessment body use 

testing methods other than those 

specified in the relevant CPSC rule and/ 

or test method? 

Proposed § 1112.21 would require a 

CPSC-accepted laboratory to use only a 

test method specified by the CPSC for a 

particular CPSC rule and/or test 

method, for any test conducted for 

purposes of section 14 of the CPSA. The 

proposed rule would require 

laboratories to use a CPSC-specified test 

method(s) for several reasons. First, a 

specified test method firmly establishes 

how to generate test results that are 

acceptable to the CPSC as indicative of 

compliance, so there may be a common 

understanding between laboratories and 

the CPSC. Second, by specifying the test 

method, greater consistency among tests 

conducted at different laboratories is 

established. Variations between 

laboratory tests are reduced. Finally, it 

serves as a common procedure that 

accreditation bodies can use to evaluate 

a laboratory for a particular CPSC rule 

and/or test method. By evaluating to a 

CPSC-specified test method, the 

accreditation bodies can determine 

whether the laboratory meets 

competency requirements to carry out 

that particular test. 

7. Proposed § 1112.23—May a CSPCaccepted third party conformity 

assessment body subcontract work 

conducted for purposes of section 14 of 

the CPSA? 

The purpose of having each third 

party conformity assessment body 

satisfy CPSC requirements in order for 

its accreditation to be eligible for 

acceptance is to promote competent and 

consistent test results across 

laboratories. Proposed § 1112.23(a) 

would prohibit subcontracting of tests 

conducted for purposes of section 14 of 

the CPSA, unless the subcontract is to 

a CPSC-accepted laboratory. In addition, 

the CPSC’s acceptance of the scope of 

accreditation of the subcontracting 

laboratory must include the test being 

subcontracted. For example, in order for 

Laboratory A to subcontract the test for 

lead-containing paint to Laboratory B, 

Laboratory B would need to have had its 

accreditation to 16 CFR part 1303 (leadcontaining paint) accepted by the CPSC. 

In this example, we would refer to 

Laboratory A as the prime contractor, 

and Laboratory B would be the 

subcontractor. 

Any violation of this provision would 

constitute compromising the integrity of 

the testing process and could be 

grounds for withdrawal of the CPSC’s 

acceptance of the accreditation of the 

prime- and/or sub- contracting 

laboratory under proposed § 1112.47. 

Given this restriction and staff’s 

concerns about compromising the 

integrity of the testing process, we 

request comment as to whether 

subcontracting ought to be allowed and, 

if so, under what circumstances. For 

example, for what reasons should 

subcontracting of the preparation of 

samples for flammability testing, such 

as laundering or dry cleaning, be 

allowed? We are also interested in 

comments regarding subcontracting 

under other CPSC regulations and the 

relationship between subcontracting 

and the technical competence and 

protection against undue influence of 

the third party testing program as a 

whole. Under what conditions could we 

allow the CPSC-accepted laboratory to 

vouch for the independence and 

technical competence of its 

subcontractors and their testing 

processes without requiring 

accreditation of the subcontractor by a 

signatory to the ILAC–MRA? How 

would subcontracting affect the 

recordkeeping requirements of this rule? 

Proposed § 1112.23(b) would state 

that the provisions of part 1112 apply to 

all CPSC-accepted laboratories, even if 

they are a prime contractor and/or a 

subcontractor. 

8. Proposed § 1112.25—what are a third 

party conformity assessment body’s 

recordkeeping responsibilities? 

Proposed § 1112.25 would require 

third party conformity assessment 

bodies to retain certain records related 

to the tests conducted for purposes of 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
31118 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

section 14 of the CPSA. We are aware 

that ISO/IEC 17025:2005 contains some 

recordkeeping provisions of its own. For 

example, section 4.13 of ISO/IEC 

17025:2005 addresses ‘‘control of 

records’’ and requires a laboratory to 

retain technical records ‘‘for a defined 

period.’’ However, proposed § 1112.25 

would impose additional recordkeeping 

responsibilities beyond those 

established in ISO/IEC 17025:2005. 

Additional requirements are necessary 

because we have an interest in being 

able to investigate a noncompliant 

product and/or whether grounds exist 

for adverse action against a third party 

conformity assessment body. For 

example, if a product that fails to 

comply with a children’s product safety 

rule is present in the market, and the 

product was tested by a CPSC-accepted 

laboratory, we would have an interest in 

reviewing the test records related to that 

product. Additionally, ISO/IEC 

17025:2005 does not specify a recordretention period, which means different 

laboratories could retain their records 

for different periods of time. If we 

pursue an investigation, the records we 

would require in proposed § 1112.25 are 

those that would help us conduct that 

investigation. Some records, such as a 

report furnished to a customer where 

the report differs from the test record, 

may not be retained by some 

laboratories under ISO/IEC 17025:2005. 

Therefore, we would impose these 

recordkeeping requirements in addition 

to those imposed via ISO/IEC 

17025:2005. 

Proposed § 1112.25(a) would state 

that all required records must be legible. 

In terms of particular records, we would 

first require that all test reports and 

technical records related to tests 

conducted for purposes of section 14 of 

the CPSA be maintained for a period of 

at least five years from the date the test 

was conducted. We propose a 5-year 

retention period because the statute of 

limitations on civil penalties under the 

CPSA is five years. See 28 U.S.C. 2462. 

Next, the proposed rule would require 

that, in the case of a test report for a test 

conducted by a CPSC-accepted 

laboratory acting as a sub-contractor, the 

prime contractor’s test report must 

clearly identify which test(s) was 

performed by a CPSC-accepted 

laboratory acting as a subcontractor(s), 

and the test report from the CPSCaccepted laboratory acting as a 

subcontractor must be appended to the 

prime contractor’s test report. 

Proposed § 1112.25(a) would require 

that, where a report for purposes of 

section 14 of the CPSA provided by the 

laboratory to a customer is different 

from the test record, the laboratory also 

must retain the report provided to the 

customer for a period of at least five 

years from the date the test was 

conducted. Finally, the proposed rule 

also would require any and all 

laboratory internal documents 

describing testing protocols and 

procedures (such as instructions, 

standards, manuals, guides, and 

reference data) that have applied to a 

test conducted for purposes of section 

14 of the CPSA be retained for a period 

of at least five years from the date such 

test was conducted. 

Proposed § 1112.25(b) would state 

that, upon request by the CPSC, the 

laboratory must make any and all of the 

records required by this section 

available for inspection, either in hard 

copy or electronic form, within 48 

hours. We would require that, if the 

records are not in English, copies of the 

original records be made available to the 

CPSC within 48 hours, and an English 

translation of the records be made 

available by the laboratory within 30 

calendar days of the date we requested 

an English translation. 

9. Proposed § 1112.27—Must a third 

party conformity assessment body allow 

CPSC inspections related to 

investigations? 

Proposed § 1112.27 would require 

that each CPSC-accepted third party 

conformity assessment body allow an 

officer or employee duly designated by 

the Commission to enter its facility and 

conduct an inspection as a condition of 

the continued CPSC-acceptance of its 

accreditation. Such inspections would 

not be routine and/or for the purpose of 

confirming that the laboratory satisfies 

accreditation requirements. We intend 

that audits (addressed in subpart C of 

part 1112) be the vehicle by which we 

confirm that a laboratory continues to 

satisfy the requirements necessary for 

our acceptance of its accreditation. 

Rather, such inspections would be 

limited to inspections related to a CPSC 

investigation into whether a ground 

exists for adverse action against a third 

party conformity assessment body. An 

ability to enter and inspect a laboratory 

would help us investigate 

circumstances, such as an allegation of 

undue influence or the presence in the 

market of a product that fails to comply 

with a children’s product safety rule, yet 

is accompanied by a certificate based on 

a passing third party test result. In those 

cases, our investigation may need to 

include the laboratory so that we could 

attempt to obtain facts relevant to the 

case at hand. 

We would conduct such inspections 

in accordance with 16 CFR 1118.2, 

Conduct and Scope of Inspections. 

Failure to cooperate with such an 

inspection would constitute failure to 

cooperate with an investigation and 

would be grounds for suspension under 

proposed § 1112.45. 

10. Proposed § 1112.29—How does a 

third party conformity assessment body 

voluntarily discontinue its participation 

with the CPSC? 

Proposed § 1112.29(a) would provide 

that a third party conformity assessment 

body may voluntarily discontinue 

participation as a CPSC-accepted 

laboratory at any time and for any 

portion of its scope that is accepted by 

the CPSC. It also would provide the 

procedural requirements for such 

voluntary discontinuance. 

To voluntarily discontinue its 

participation as a CPSC-accepted 

laboratory, the laboratory would have to 

notify us in writing. This notification 

may be sent electronically. The notice 

would have to include the name, 

address, phone number, and electronic 

mail address of the laboratory and the 

person responsible for submitting the 

request. The notice also would need to 

include the scope of the discontinuance; 

the beginning date for the 

discontinuance; a statement that the 

laboratory understands that it must 

reapply for acceptance of the 

accreditation scope for which it is 

requesting discontinuance; and 

verification that the person requesting 

the discontinuance has the authority to 

make such a request on behalf of the 

laboratory. 

Proposed § 1112.29(b) would state 

that we may verify the information 

submitted in a notice of voluntary 

discontinuance. 

Proposed § 1112.29(c) would explain 

that, either upon receipt of a notice for 

voluntary discontinuance as a CPSCaccepted third party conformity 

assessment body or after verifying the 

information in a notice, we will update 

our Web site to indicate that we no 

longer accept the accreditation of the 

third party conformity assessment body 

as of the date provided and for the scope 

indicated in the notice. 

Proposed § 1112.29(d) would note 

that we may begin or continue an 

investigation related to an adverse 

action under this part, or any other legal 

action, despite the voluntary 

discontinuation of a laboratory. 

C. Subpart C—Audit Requirements for 

Third Party Conformity Assessment 

Bodies 

1. Proposed § 1112.35(b)—When must 

an audit be conducted? 

As explained in the audit final rule 

published elsewhere in this issue of the 


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Federal Register, for purposes of part 

1112, an audit consists of two parts. The 

first part, known as ‘‘reassessment,’’ is 

an examination by an accreditation 

body to determine whether the third 

party conformity assessment body meets 

or continues to meet the conditions for 

accreditation. The second part, which 

we refer to as ‘‘examination,’’ is the 

resubmission of the ‘‘Consumer Product 

Conformity Assessment Body 

Acceptance Registration Form’’ (CPSC 

Form 223) and accompanying 

documentation by the laboratory, and 

the CPSC’s examination of the 

resubmitted materials. 

The reassessment portion of an audit 

is conducted, at a minimum, at the 

frequency established by its 

accreditation body. Proposed 

§ 1112.35(b) would establish when the 

examination portion of an audit must be 

conducted. 

Proposed § 1112.35(b)(1) would have 

each laboratory submit a new CPSC 

Form 223 and applicable accompanying 

documentation, no less than every two 

years. The proposed rule would begin 

the implementation of this provision by 

assigning an audit date to each CPSCaccepted laboratory. The initial audit 

date, which will be assigned based on 

such factors as when the laboratory was 

last accepted by the CPSC, and the 

expiration date of the laboratory’s ISO/ 

IEC 17025:2005 certificate, will be no 

sooner than three months, and no later 

than two years, after any final rule 

resulting from this proposed rule is 

published. Laboratories that were not 

previously CPSC-accepted laboratories 

and that apply to the CPSC after the 

publication of a final rule resulting from 

this proposed rule will be issued an 

audit date based upon the date of CPSC 

acceptance of accreditation as posted on 

the CPSC Web site. 

Proposed § 1112.35(b)(2) would note 

that proposed § 1112.13(a)(1) would 

require a third party conformity 

assessment body to submit a new CPSC 

Form 223 whenever the information 

supplied on the form changes. If the 

third party conformity assessment body 

submits a new CPSC Form 223 to 

provide updated information, the third 

party conformity assessment body may 

elect to have the new CPSC Form 223 

satisfy the audit requirement of 

proposed § 1112.35(b)(1). If the 

laboratory also intends to satisfy the 

audit requirement of proposed 

§ 1112.35(b)(1), it would need to 

indicate that intent clearly when it 

submits a CPSC Form 223. In addition, 

the laboratory would need to upload all 

applicable accompanying 

documentation. 

Proposed § 1112.35(b)(3) would state 

that, at least 30 days before the date by 

which a third party conformity 

assessment body must submit a CPSC 

Form 223 for audit purposes, we will 

notify the body, in writing, of the 

impending audit deadline. The notice 

may be delivered by electronic mail. A 

laboratory may request an extension of 

the deadline for the examination portion 

of the audit, but it must indicate how 

much additional time is requested, and 

it also must explain why such an 

extension is warranted. The CPSC will 

notify the laboratory whether its request 

for an extension has been granted. 

D. Subpart D—Adverse Actions: Types, 

Grounds, Allegations, Procedural 

Requirements, and Publication 

Proposed subpart D would implement 

section 14(e) of the CPSA. It would 

establish whether, when, and how we 

may deny a third party conformity 

assessment body’s application and 

suspend and/or withdraw a previouslygranted acceptance of a laboratory’s 

accreditation. It also would establish 

how a person may submit to the CPSC 

information alleging a ground for 

adverse action, including an allegation 

of undue influence. This subpart also 

would address the publication of 

adverse actions. 

1. Proposed § 1112.41—What are the 

possible adverse actions the CPSC may 

take against a third party conformity 

assessment body? 

Proposed § 1112.41 would list the 

potential adverse actions we may take 

against a third party conformity 

assessment body. Proposed § 1112.41(a) 

lists the possible actions: denial of 

acceptance of accreditation; suspension 

of acceptance of accreditation; or 

withdrawal of acceptance of 

accreditation. These actions will each be 

discussed further below, in relation to 

the proposed sections that address each 

possible action. 

Proposed § 1112.41(b) would state 

that withdrawal of acceptance of 

accreditation can be on a temporary or 

permanent basis, and the CPSC may 

immediately withdraw its acceptance in 

accordance with § 1112.53 of this part. 

2. Proposed § 1112.43—What are the 

grounds for denial of an application? 

Proposed § 1112.43(a) would list the 

bases for denying an application for 

acceptance of accreditation from a third 

party conformity assessment body. 

There would be three reasons for 

denying an application. 

First, proposed § 1112.43(a)(1) would 

state that we may deny a laboratory’s 

application if the laboratory failed to 

submit a complete application. We 

would state that all information and/or 

attestations required by CPSC Form 223 

are necessary components of an 

application. We also would state that all 

accompanying documentation required 

in connection with an application is a 

necessary component of an application. 

We would provide notice of a deficiency 

and would deny an application if the 

laboratory failed to correct the 

deficiency within 30 days. 

Proposed § 1112.43(a)(2) would 

provide the second basis upon which 

we would be able to deny an 

application. The proposed rule would 

address the submission of false or 

misleading information concerning a 

material fact(s) on either an application, 

any materials accompanying an 

application, or on any other information 

provided to the CPSC related to a 

laboratory’s ability to become or to 

remain a CPSC-accepted laboratory. A 

fact would be considered material if its 

inclusion in the application, any 

materials accompanying an application, 

or on any other information provided to 

the CPSC, would have resulted in the 

application’s denial. 

Third, proposed § 1112.43(a)(3) would 

state that we may deny an application 

if the applicant laboratory failed to 

satisfy the necessary requirements 

described in § 1112.13, such as ISO/IEC 

17025:2005 accreditation by an ILAC– 

MRA signatory accreditation body for 

the scope for which acceptance of 

accreditation is being sought. 

Proposed § 1112.43(b) would state 

that the CPSC’s denial of an application 

will follow the process described in 

§ 1112.51 of this part. 

3. Proposed § 1112.45—What are the 

grounds for suspension of CPSC 

acceptance? 

Section 14(e)(3) of the CPSA states 

that the Commission may suspend the 

accreditation of a conformity assessment 

body if it fails to cooperate with the 

Commission in an investigation under 

section 14 of the CPSA. Proposed 

§ 1112.45 would implement that 

statutory provision. 

The procedures relevant to adverse 

actions would be addressed in proposed 

§ 1112.51, which we will describe and 

discuss more fully below. For current 

purposes, however, we note that 

proposed § 1112.51(a) would provide 

that the CPSC may investigate when it 

is aware that grounds for an adverse 

action may exist. For example, if we 

receive an allegation of undue influence 

concerning a CPSC-accepted laboratory, 

we may (depending on the strength of 

the allegation) launch an investigation. 

As another example, if a product was 


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present in the market that failed to 

comply with a children’s product safety 

rule, yet is supported by a certificate 

based on a CPSC-accepted laboratory’s 

passing test result, we may investigate 

whether the laboratory is, in fact, 

conducting tests according to a CPSCrequired test method. Under proposed 

§ 1112.51(a)(4), we would provide 

written notice to a laboratory upon 

commencement of an investigation. 

Section 1112.45(a) would state that 

we may suspend our acceptance of a 

laboratory’s accreditation for any 

portion of its CPSC scope when the 

laboratory fails to cooperate with an 

investigation under section 14 of the 

CPSA. The proposed rule would state 

further that a third party conformity 

assessment body ‘‘fails to cooperate’’ 

when it does not respond to CPSC 

inquiries or requests, or responds in a 

manner that is unresponsive, evasive, 

deceptive, or substantially incomplete, 

or when the laboratory fails to cooperate 

with an investigatory inspection under 

proposed § 1112.27. 

If we determine that a laboratory is 

not cooperating with an investigation, 

under proposed § 1112.51(b), we would 

provide an initial notice of adverse 

action to the laboratory. This initial 

notice would state that the CPSC 

proposes to suspend the laboratory, and 

it would specify the actions the 

laboratory would need to take to avoid 

suspension. Proposed § 1112.45(b) 

would state that suspension will last 

until the laboratory complies, to our 

satisfaction, with required actions, as 

outlined in the initial notice described 

in proposed § 1112.51(b), or until we 

withdraw our acceptance of the 

laboratory. 

Proposed § 1112.45(c) would provide 

that we will lift the suspension of CPSC 

acceptance if we determine that the 

third party conformity assessment body 

is cooperating sufficiently with the 

investigation. The suspension would lift 

as of the date of our written notification 

to the laboratory, which may be by 

electronic mail, indicating that we are 

lifting the suspension. 

4. Proposed § 1112.47—What are the 

grounds for withdrawal of CPSC 

acceptance? 

Proposed § 1112.47 would establish 

the grounds upon which we may 

withdraw acceptance of the 

accreditation of a third party conformity 

assessment body for any portion of its 

CPSC scope. 

The first ground for withdrawal 

would be that a manufacturer, private 

labeler, governmental entity, or other 

interested party has exerted undue 

influence on such conformity 

assessment body, or otherwise 

interfered with, or compromised, the 

integrity of the testing process. Proposed 

§ 1112.3 would define ‘‘undue 

influence’’ to mean that a manufacturer, 

private labeler, governmental entity, or 

other interested party affects a third 

party conformity assessment body, such 

that commercial, financial, or other 

pressures compromise the integrity of 

its testing processes or results. Undue 

influence can take many forms. For 

example, it would be undue influence if 

a laboratory director instructs laboratory 

personnel to alter a test report to 

indicate a passing result, rather than a 

failing result, because a customer has 

exerted pressure on the laboratory 

director by threatening to withdraw its 

business if the laboratory report 

indicates a failing result. Another 

example of undue influence would be if 

a manager of a firewalled laboratory 

asks a laboratory technician not to 

report a failing test result because it 

would delay a large shipment of 

products. Similarly, in the case of a 

firewalled laboratory, a manufacturing 

manager who urges the laboratory to 

complete the testing promptly and ‘‘cut 

corners’’ on the normal testing 

procedures so that the factory can ship 

product to meet a production quota for 

the month, would be attempting to 

apply undue influence. In the 

governmental laboratory context, undue 

influence might take the form of a 

government official influencing a 

laboratory to report falsely that a sample 

passed a test in order to facilitate 

exports. 

The second ground for withdrawal, at 

proposed § 1112.47(b), would be that 

the third party conformity assessment 

body failed to comply with an 

applicable protocol, standard, or 

requirement under proposed subpart C 

of this part. This provision implements 

section 14(e)(1)(B) of the CPSA. 

The third ground for withdrawal, at 

proposed § 1112.47(c), would state that 

we may withdraw our acceptance of the 

accreditation of a laboratory if the 

laboratory fails to comply with any 

provision in subpart B of this part. As 

a reminder, proposed subpart B would 

establish the general requirements 

pertaining to third party conformity 

assessment bodies, such as 

requirements, processes, and timing 

related to applying for CPSC acceptance, 

recordkeeping requirements, and 

limitations on subcontracting. Thus, 

examples of failure to comply with 

subpart B would include a laboratory 

that loses its ISO/IEC 17025:2005 

accreditation (either for the entire 

laboratory or for any portion of its CPSC 

scope) or has such accreditation 

suspended; a firewalled laboratory that 

fails to continue to satisfy the relevant 

statutory criteria; or a laboratory that 

fails to use, in relation to a test 

conducted for purposes of section 14 of 

the CPSA, a CPSC-specified test 

method. 

5. Proposed § 1112.49—How may a 

person submit information alleging 

grounds for adverse action, and what 

information should be submitted? 

Proposed § 1112.49(a) would allow 

any person to submit information 

alleging that one or more of the grounds 

for adverse action exists. The 

information may be submitted in 

writing or electronically. Any request 

for confidentiality would need to be 

indicated clearly in the submission. 

Proposed § 1112.49(a) also would list 

the information to be included in a 

submission alleging grounds for adverse 

action. First, the submission should 

include the name and contact 

information of the person making the 

allegation. Second, the submission 

should identify the laboratory against 

whom the allegation is being made, as 

well as any officials or employees of the 

laboratory relevant to the allegation, in 

addition to contact information for those 

individuals. Third, a person alleging a 

ground for adverse action should 

identify any manufacturers, distributors, 

importers, private labelers, or 

governmental entities relevant to the 

allegation, along with any officials or 

employees of the manufacturers, 

distributors, importers, private labelers, 

and/or governmental entities relevant to 

the allegation, as well as contact 

information for those individuals. 

Fourth, a submission should include a 

description of acts and/or omissions to 

support each asserted ground for 

adverse action. Generally, the 

submission should describe, in detail, 

the basis for the allegation that grounds 

for adverse action against a laboratory 

exists. In addition to a description of the 

acts and omissions and their 

significance, a description may include: 

dates, times, persons, companies, 

governmental entities, locations, 

products, tests, test results, equipment, 

supplies, frequency of occurrence, and 

negative outcomes. When possible, the 

submission should attach documents, 

records, photographs, correspondence, 

notes, electronic mails, or any other 

information that supports the basis for 

the allegations. Finally, a submission of 

grounds for adverse action should 

include a description of the impact of 

the acts and/or omissions, where 

known. 

Proposed § 1112.49(b) would state 

that, upon receiving the information, we 


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would review the information to 

determine if it is sufficient to warrant an 

investigation. We may deem the 

information insufficient to warrant an 

investigation if the information fails to 

address adequately the categories of 

information outlined in paragraph (a) of 

this section. 

6. Proposed § 1112.51—What are the 

procedures relevant to adverse actions? 

Proposed § 1112.51 would describe 

the process by which we may deny an 

application from a laboratory, suspend 

our acceptance of the accreditation of a 

laboratory, withdraw our acceptance of 

the accreditation of a laboratory on a 

temporary or permanent basis; and/or 

immediately temporarily withdraw our 

acceptance of the accreditation of a 

laboratory. 

Proposed § 1112.51(a)(1) would state 

that investigations, for purposes of part 

1112, are investigations into grounds for 

an adverse action against a third party 

conformity assessment body. Proposed 

§ 1112.51(a)(2) would explain that we 

would use our Procedures for 

Investigations, Inspections, and 

Inquiries, 16 CFR part 1118, subpart A, 

to investigate under this part. 

Proposed § 1112.51(a)(3) would 

provide that an investigation under this 

part may include: any act we may take 

to verify the accuracy, veracity, and/or 

completeness of information received in 

connection with an application for 

acceptance of accreditation; a 

submission alleging grounds for an 

adverse action; or any other information 

we receive, which relates to a 

laboratory’s ability to become or remain 

a CPSC-accepted laboratory. 

Proposed § 1112.51(a)(4) would state 

that we would begin an investigation by 

providing written notice, which may be 

electronic, to the laboratory. The notice 

would inform the laboratory that we 

have received information sufficient to 

warrant an investigation, and it would 

describe the information received by the 

CPSC, as well as describe our 

investigative process. The notice also 

would inform the laboratory that failure 

to cooperate with a CPSC investigation 

is grounds for suspension. 

Proposed § 1112.51(a)(5) would state 

that any notice sent by the CPSC under 

proposed § 1112.35(b)(3) informing the 

third party conformity assessment body 

that it must submit a CPSC Form 223 for 

audit purposes, constitutes a notice of 

investigation for purposes of this 

section. The examination portion of an 

audit under § 1112.33(c) of this part 

(which we have finalized elsewhere in 

this issue of the Federal Register) 

constitutes an investigation for purposes 

of this section. 

Failure to cooperate in an 

investigation under this part is grounds 

for the CPSC to suspend its acceptance 

of the accreditation of a laboratory 

under proposed § 1112.45. In addition, 

we note that section 19(a)(13) of the 

CPSA makes it unlawful for any person 

to make a material misrepresentation to 

an officer or employee of the 

Commission in the course of an 

investigation. 

Proposed § 1112.51(b) would state 

that if, after investigation, we determine 

that grounds for adverse action exist, 

and we propose to take an adverse 

action against a laboratory, we would 

notify the laboratory, in writing, which 

may be electronic, about the proposed 

adverse action. If the proposed adverse 

action is suspension or withdrawal, the 

CPSC’s notice formally would begin a 

proceeding to suspend or withdraw our 

acceptance of its accreditation, as 

described in section 14(e) of the CPSA. 

The notice would contain the CPSC’s 

proposed adverse action; specify 

grounds on which the proposed adverse 

action is based; and provide findings of 

fact to support the proposed adverse 

action. This notice also would contain, 

when appropriate, specific actions a 

third party conformity assessment body 

must take to avoid an adverse action. 

For example, if a laboratory submitted 

an incomplete application, we would 

notify the laboratory of the deficiencies 

that the laboratory would need to 

remedy to avoid denial of the 

application. Also, when the proposed 

adverse action is withdrawal, the notice 

would contain consideration of the 

criteria set forth in proposed 

§ 1112.51(d)(1). 

The notice in proposed § 1112.51(b) 

also would contain the time period by 

which a laboratory has to respond to the 

notice. In general, the notice would 

inform the laboratory that it has 30 

calendar days to respond. A laboratory 

may request an extension of the 

response time, but it must explain why 

such an extension is warranted and 

indicate the amount of additional time 

needed for a response. Finally, the 

notice would state that, except under 

proposed § 1112.53 (which we discuss 

below in section IV.D.7 of this 

preamble), a CPSC-accepted laboratory 

would be able to continue to conduct 

tests for purposes of section 14 of the 

CPSA until a Final Notice of adverse 

action is issued. 

Proposed § 1112.51(c) would address 

how the laboratory may respond to the 

initial notice. The proposed rule would 

require the laboratory’s response to be 

in writing, which may be by electronic 

mail, and in English. 

Responses contemplated under 

proposed § 1112.51(c) could include, 

but would not be limited to, an 

explanation or refutation of material 

facts upon which the CPSC’s proposed 

action is based, supported by 

documents or a sworn affidavit; results 

of any internal review of the matter, and 

action(s) taken as a result; or a detailed 

plan and schedule for an internal 

review. Proposed § 1112.51(c) would 

explain that the response is the 

laboratory’s opportunity to state its case 

that the ground(s) for adverse action 

does not exist, or explain why the CPSC 

should not pursue the proposed adverse 

action, or any portion of the proposed 

adverse action. If a laboratory responds 

to the notice in a timely manner, we 

would review the response, and, if 

necessary, conduct further investigation 

to explore or resolve issues bearing on 

whether grounds exist for adverse 

action, and the nature and scope of the 

proposed adverse action. If a laboratory 

does not submit a response to the notice 

in a timely manner, we would be able 

to proceed to a Final Notice, as 

described in proposed § 1112.51(e), 

without further delay. 

Proposed § 1112.51(d) would address 

the adverse action proceeding. Proposed 

§ 1112.51(d)(1) would reiterate the 

factors that we must consider in any 

proceeding to withdraw under section 

14(e)(2)(A) of the CPSA. The proposed 

rule would state that we will consider 

the gravity of the laboratory’s action or 

failure to act, including: Whether the 

action or failure to act resulted in injury, 

death, or the risk of injury or death; 

whether the action or failure to act 

constitutes an isolated incident or 

represents a pattern or practice; and 

whether and when the third party 

conformity assessment body initiated 

remedial action. 

Proposed § 1112.51(d)(2) would state 

that, in all cases, we would review and 

take under advisement, the response 

provided by the third party conformity 

assessment body. Except for cases under 

proposed § 1112.51(d)(3), we would 

determine what action is appropriate 

under the circumstances. Proposed 

§ 1112.51(d)(3) would clarify that any 

suspension or withdrawal of a 

firewalled laboratory would occur by 

order of the Commission. We consider 

this provision to be consistent with 

section 14(f)(2)(D) of the CPSA and its 

requirement that the accreditation of a 

firewalled laboratory may be accepted 

by Commission order only. 

Proposed § 1112.51(d)(4) would 

reiterate section 14(e)(2)(B)(i) of the 

CPSA, and would state that the CPSC 

may withdraw its acceptance of the 

accreditation of a laboratory on a 


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permanent or temporary basis. Proposed 

§ 1112.51(d)(5) would reiterate section 

14(e)(2)(B)(ii) of the CPSA and would 

state that, if we withdraw our 

acceptance of the accreditation of a 

laboratory, we may establish 

requirements for the reacceptance of the 

laboratory’s accreditation. Any such 

requirements would be related to the 

reason(s) for the withdrawal. 

Proposed § 1112.51(e) would detail 

the Final Notice. If, after reviewing a 

laboratory’s response to a notice, and 

conducting additional investigation, 

where necessary, we determine that 

grounds for adverse action exist, we 

would send a Final Notice to the 

laboratory, in writing, which may be 

electronic. The Final Notice would state 

the adverse action that we are taking, 

the specific grounds on which the 

adverse action is based, and the findings 

of fact that support the adverse action. 

When the adverse action is withdrawal, 

the Final Notice would address the 

consideration of the criteria as set forth 

in proposed § 1112.51(d)(1) and would 

state whether the withdrawal is 

temporary or permanent, and, if the 

withdrawal is temporary, the duration 

of the withdrawal. The Final Notice 

would inform the laboratory that its 

accreditation is no longer accepted by 

the CPSC as of the date of the Final 

Notice of denial, suspension, or 

withdrawal for any specified portion(s) 

of its CPSC scope. The Final Notice also 

would inform the laboratory that the 

CPSC Web site will be updated to reflect 

adverse actions taken against a 

previously CPSC-accepted laboratory. 

Finally, the Final Notice would inform 

the laboratory whether it may submit a 

new application. 

Proposed § 1112.51(f) would state 

that, upon receipt of a Final Notice, a 

third party conformity assessment body, 

as applicable, may submit a new 

application (if the Final Notice 

indicated such) or file an 

Administrative Appeal. 

Proposed § 1112.51(g) would address 

Administrative Appeals. Except for 

cases covered in proposed 

§ 1112.51(g)(2), a laboratory could file 

an Administrative Appeal with the 

Office of the Executive Director. The 

Administrative Appeal would need to 

be sent by mail within 30 calendar days 

of the date on the Final Notice; 

proposed § 1112.51(g) would provide 

the appropriate mailing and electronic 

mail addresses. The proposed rule 

would require all appeals to be in 

English; to explain the nature and scope 

of the issues appealed from in the Final 

Notice; and describe, in detail, the 

reasons why the laboratory believes that 

no grounds for adverse action exist. 

The Executive Director would issue a 

Final Decision within 60 calendar days 

of receipt of an Administrative Appeal. 

If the Executive Director’s Final 

Decision would require more than 60 

calendar days, he or she would notify 

the third party conformity assessment 

body that more time is required, state 

the reason(s) why more time is required, 

and, if feasible, include an estimated 

date for a Final Decision to issue. 

Proposed § 1112.51(g)(2) would 

address the circumstance in which the 

Commission has suspended or 

withdrawn its acceptance of the 

accreditation of a firewalled laboratory. 

Because suspensions and withdrawals 

of firewalled laboratories must occur by 

order of the Commission, 

Administrative Appeals, in these cases, 

would be filed with the Commission. 

The Administrative Appeal would need 

to be sent to the Office of the Secretary 

by mail within 30 calendar days of the 

date on the Final Notice. The proposed 

rule would require all appeals to be in 

English, to explain the nature of the 

issues appealed in the Final Notice, and 

to describe in detail the reasons why the 

laboratory believes that no ground(s) 

exist for adverse action. 

7. Proposed § 1112.53—Can the CPSC 

immediately withdraw its acceptance of 

the accreditation of a third party 

conformity assessment body? 

Under proposed § 1112.51(b)(7) a 

CPSC-accepted third party conformity 

assessment body generally would be 

able to continue to conduct tests for 

purposes of section 14 of the CPSA 

during an investigation and the 

procedures leading up to an adverse 

action, until a Final Notice of adverse 

action is issued. Proposed § 1112.53 

would establish a means of immediately 

and temporarily withdrawing the 

accreditation of a laboratory in the rare 

circumstance that it would be in the 

public interest to remove our acceptance 

of the laboratory while we pursue an 

investigation and potential adverse 

action against the laboratory under 

proposed § 1112.51. 

Section 12 of the CPSA addresses 

imminent hazards. Proposed § 1112.53 

would use section 12 of the CPSA as a 

guide. We do not foresee many 

circumstances under which we would 

be so concerned with the testing 

conducted by a CPSC-accepted 

laboratory that we would need to stop 

the laboratory from conducting third 

party tests of children’s products while 

we investigate and proceed against the 

laboratory. However, because any such 

circumstances would endanger the 

public, the proposed rule would enable 

us to do exactly that in certain 

prescribed conditions and after 

following particular procedures. 

Proposed § 1112.53(a) would state 

that, when it is in the public interest to 

protect health and safety, and 

notwithstanding any other provision of 

this part, we would be able to 

immediately and temporarily withdraw 

our acceptance of a laboratory’s 

accreditation for any portion of its CPSC 

scope while we pursue an investigation 

and potential adverse action. Proposed 

§ 1112.53(a)(1) would define ‘‘in the 

public interest to protect health and 

safety’’ to mean that the CPSC has 

credible evidence that: (1) The integrity 

of test(s) being conducted under a scope 

for which we have accepted the 

laboratory’s accreditation have been 

affected by undue influence or 

otherwise interfered with or 

compromised; and (2) any portion of a 

CPSC scope for which we have accepted 

the laboratory’s accreditation involve a 

product(s) which, if noncompliant with 

CPSC rules, bans, standards, and/or 

regulations, constitutes an imminently 

hazardous consumer product under 

section 12 of the CPSA. 

Proposed § 1112.53(a)(2) would state 

that, when presented with an allegation 

that, if credible, would result in 

immediate and temporary withdrawal of 

CPSC acceptance of a third party 

conformity assessment body’s 

accreditation, the investigation and 

adverse action procedures described in 

§ 1112.51 apply, except that instead of 

the timeframes described in § 1112.51, 

the following timeframes would apply 

when the CPSC pursues immediate and 

temporary withdrawal: The Initial 

Notice will generally inform the third 

party conformity assessment body that it 

has 7 calendar days to respond; an 

administrative appeal of a Final Notice 

of immediate and temporary withdrawal 

will be timely if filed within 7 calendar 

days of the date of the Final Notice. 

Proposed § 1112.53(b) would state 

that, if the laboratory is already the 

subject of an investigation or adverse 

action process, the immediate and 

temporary withdrawal would remain in 

effect until either we communicate in 

writing that the immediate and 

temporary withdrawal has been lifted, 

the investigation concludes and we do 

not propose an adverse action, or the 

adverse action process concludes with 

denial, suspension, or withdrawal. 

Under proposed § 1112.53(c), if the 

laboratory is not already the subject of 

an investigation or adverse action 

process under § 1112.51, an 

investigation under § 1112.51(a) would 

be launched based on the same 

information that justified the immediate 

and temporary withdrawal. 


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2Based on 2007 data from the U.S. Census Bureau 

that was compiled by the U.S. Small Business 

Continued 

8. Proposed § 1112.55—Will the CPSC 

publish adverse actions? 

Proposed § 1112.55 would state that, 

immediately following a final adverse 

action, we would be able to publish the 

fact of a final adverse action, the text of 

a final adverse action, or a summary of 

the substance of a final adverse action. 

In addition, after issuance of a final 

adverse action, we would amend our 

Web site listing of CPSC-accepted 

laboratories to reflect the nature and 

scope of such adverse action. 

E. Proposed § 1118.2—Conduct and 

Scope of Inspections 

The Commission’s regulations on 

investigations, inspections, and 

inquiries under the CPSA are located at 

16 CFR part 1118. Subpart A of part 

1118 prescribes CPSC procedures for 

investigations, inspections, and 

inquiries. Section 1118.2 addresses 

topics such as how the CPSC conducts 

an inspection, which sites the CPSC has 

authority to inspect, and what the CPSC 

may view or obtain during an 

inspection. 

The proposed rule would amend 

§ 1118.2(a) in two ways. First, it would 

include firewalled third party 

conformity assessment bodies as entities 

that we may inspect. This amendment is 

necessary to conform § 1118.2(a) with 

the statutory language in section 16(a) of 

the CPSA and the inspection provision 

at proposed § 1112.27. Second, it would 

remove the word ‘‘consumer’’ before the 

word ‘‘product’’ throughout paragraph 

(a), for accuracy. Some children’s 

products regulated by the Commission 

and that are required by the CPSA to be 

third party tested are not regulated 

primarily under the CPSA. For example, 

some toys are regulated under the 

Federal Hazardous Substances Act, 15 

U.S.C. 1261–1278. To be consistent with 

the inspection provision at proposed 

§ 1112.27, the references to ‘‘product’’ 

must be broad enough to include more 

than just products subject to CPSA 

safety standards. 

Normally, we would use the plain 

language ‘‘must’’ rather than ‘‘shall’’ 

when describing mandatory 

requirements in a rule. However, 

because we are amending one paragraph 

of a section that was drafted using 

‘‘shall,’’ we will continue to use ‘‘shall’’ 

in this paragraph, to avoid any potential 

confusion that might arise from the 

appearance of inconsistent terminology 

within § 1118.2. 

V. Regulatory Flexibility Act 

A. Introduction 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. chapter 6, requires the agency 

to evaluate the economic impact of this 

proposed rule on small entities. The 

RFA defines ‘‘small entities’’ to include 

small businesses, small organizations, 

and small governmental jurisdictions. 

Section 603 of the RFA requires the 

CPSC to prepare an initial regulatory 

flexibility analysis and make it available 

to the public for comment when the 

notice of proposed rulemaking is 

published. The initial regulatory 

flexibility analysis must describe the 

impact of the proposed rule on small 

entities and identify any alternatives 

that may reduce the impact. 

Specifically, the initial regulatory 

flexibility analysis must contain: 

1. [A] description of the reasons why 

action by the agency is being considered; 

2. [A] succinct statement of the objectives 

of, and legal basis for, the proposed rule; 

3. [A] description of and, where feasible, 

an estimate of the number of small entities 

to which the proposed rule will apply; 

4. [A] description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the proposed 

rule, including an estimate of the classes of 

small entities subject to the requirements and 

the type of professional skills necessary for 

the preparation of reports or records; 

5. [A]n identification, to the extent 

possible, of all relevant Federal rules which 

may duplicate, overlap, or conflict with the 

proposed rule. 

5 U.S.C. 603(b). 

Additionally, the initial regulatory 

flexibility analysis must contain a 

description of any significant 

alternatives to the proposed rule that 

accomplish the stated objectives of the 

proposed rule while minimizing the 

economic impact on small entities. 

B. Reasons the Commission is 

Considering the Proposed Rule 

Section 14(a)(2)of the CPSA requires 

that a manufacturer or private labeler of 

a children’s product subject to a 

children’s product safety rule submit 

samples of the product to a CPSCaccepted third party conformity 

assessment body for testing for 

compliance with the rule. Based on the 

testing, the manufacturer or private 

labeler must issue a certificate that 

certifies that the children’s product 

complies with the applicable children’s 

product safety rule(s). This proposed 

rule would codify, inter alia, the 

requirements and process by which a 

laboratory may apply for CPSC 

acceptance of its accreditation, the 

process for a laboratory to voluntarily 

discontinue providing testing to support 

a children’s product certification, and 

the procedures by which the CPSC may 

suspend or withdraw its acceptance of 

the accreditation of a laboratory. 

C. Objectives of and Legal Basis for the 

Proposed Rule 

The primary objective of the proposed 

rule is to codify the requirements 

pertaining to laboratories, including the 

requirements and processes related to 

obtaining CPSC acceptance of their 

accreditation. Codifying the 

requirements related to obtaining CPSC 

acceptance of accreditation will make it 

easier for interested parties to locate the 

requirements because, from September 

2008 through August 2011, the CPSC 

has issued 19 notices of requirements 

pertaining to specific regulations or test 

methods. This rule would compile the 

requirements in a single location. 

The proposed rule also would 

establish the grounds for and 

procedures by which the CPSC could 

suspend or withdraw its acceptance of 

the accreditation of a laboratory. 

Additionally, where the required test 

method(s) is not specified in a 

children’s product safety rule, 

provisions in the proposed rule 

(§ 1112.15, § 1112.17) would formally 

establish the test method(s) that 

laboratories must use to assess 

conformity with the particular rule. 

The legal bases of the rule are found 

in section 14 of the CPSA, as amended 

by section 102 of the CPSIA, and section 

3 of the CPSIA. Section 3 of the CPSIA 

grants the CPSC the authority to issue 

regulations to implement the CPSIA and 

the amendments made by the CPSIA. 

Section 14(a)(3) of the CPSA provides 

the authority for the CPSC to establish 

the accreditation requirements for 

laboratories. Section 14(e) of the CPSA 

provides the authority for the CPSC to 

suspend and/or withdraw the 

acceptance of the accreditation of a 

laboratory. 

D. Description and Estimate of the 

Number of Small Entities to Which the 

Proposed Rule Would Apply 

This proposed rule would apply to 

laboratories that intend to offer their 

testing services to manufacturers and 

private labelers of children’s products 

for purposes of supporting a 

certification that the products conform 

to applicable children’s product safety 

rules. The proposed rule would not 

impose any requirements on 

laboratories that do not intend to 

provide these services. 

Although there are 5,041 firms 

classified as ‘‘testing laboratories’’ 

(NAICS code 54138) in the United 

States,2 only a small subset of these 


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Administration (available at http://www.sba.gov/ 

advo/research/us_rec07.txt). 

3CPSC has recognized the accreditations of at 

least 346 (if using the date of Aug 17, 2011) testing 

laboratories worldwide. However, most of the 

laboratories are located in other countries. Only 

domestic firms are relevant for purposes of the RFA. 

laboratories are expected to provide 

third party conformity assessments of 

children’s products for purposes of 

section 14(a)(2)of the CPSA. As of 

August 29, 2011, the CPSC has accepted 

the accreditation of 87 laboratories 

located in the United States.3 This 

number could increase somewhat over 

the next year or so as the remaining 

notices of requirements for accreditation 

are issued and the stays of enforcement 

of the requirements for third party 

testing that the Commission issued 

pending clarification of the regulations 

and testing requirements, are lifted. Of 

the laboratories located in the United 

States with CPSC-accepted 

accreditations, 12 are owned by large, 

foreign-based companies and 22 are 

large, U.S.-based companies. The 

remaining 53 laboratories (about 61 

percent) could be small firms, according 

to the criteria established by the U.S. 

Small Business Administration (SBA), 

which for a laboratory is revenue of less 

than $12 million annually. 

E. Projected Reporting, Recordkeeping, 

and Other Compliance Requirements 

1. Accreditation Requirements 

The proposed rule would establish 

the requirements for CPSC acceptance of 

the accreditation of a laboratory. The 

rule would apply only to laboratories 

that intend to provide third party testing 

of children’s products in support of the 

certification required by section 14(a)(2) 

of the CPSA. The proposed rule would 

not impose any requirements on 

laboratories that do not intend to 

provide these services. 

The proposed rule would require that, 

as a condition of CPSC acceptance of its 

accreditation, the laboratory must be 

accredited to the Standard ISO/IEC 

17025:2005, ‘‘General Requirements for 

the Competence of Testing and 

Calibration Laboratories.’’ The 

accreditation must be by an 

accreditation body that is a signatory to 

the International Laboratory 

Accreditation Cooperation—Mutual 

Recognition Arrangement (ILAC–MRA). 

The scope of the accreditation must list 

the CPSC safety rule(s) and/or test 

method(s) for which acceptance is 

sought. This aspect of the proposed rule 

would simply codify the existing 

conditions for CPSC acceptance of 

accreditation, which have been stated in 

every notice of requirements published 

by the CPSC. 

The proposed rule would require that 

laboratories provide the CPSC with their 

accreditation certificate and scope 

documents. These records are normally 

generated during the accreditation 

process and can be provided to the 

CPSC electronically. The application 

form for the CPSC acceptance of 

accreditation is CPSC Form 223. This is 

an electronic application form and all of 

the information that is required to be 

supplied on the form should be readily 

available to the laboratory. The 

professional skills required to complete 

CPSC Form 223 and the related 

documents are skills that a competent, 

accredited laboratory would be expected 

to have. 

The proposed rule also would require 

firewalled laboratories to submit 

additional materials. The additional 

documents would provide evidence 

that, despite the fact that the laboratory 

is managed, owned, or controlled by a 

manufacturer or private labeler, the 

testing process is independent of that 

relationship. The acceptance of a 

firewalled laboratory’s accreditation 

would occur only by Commission order 

after it has made certain findings. The 

additional documents required to 

support the findings include: 

• The laboratory’s policies and procedures 

that explain: 

Æ How the third party conformity 

assessment body will protect its test results 

from undue influence by the manufacturer, 

private labeler, or other interested party; 

Æ That the CPSC will be notified 

immediately 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 

Æ That allegations of undue influence may 

be reported confidentially to the CPSC; 

• Training documents, including a 

description of the training program content, 

showing how employees are trained annually 

on the policies and procedures described 

above. 

• Training records listing the staff 

members who received the required training. 

The records must include training dates, 

location, and the name and title of the 

individual providing the training; 

• An organizational chart(s) of the 

laboratory that includes the names of all 

laboratory personnel, both temporary and 

permanent, and their reporting relationship 

within the laboratory; 

• An organizational chart(s) of the broader 

organization that identifies the reporting 

relationships of the laboratory within the 

broader organization (using both position 

titles and staff names); and 

• A list of all laboratory personnel with 

reporting relationships outside of the 

laboratory. The list must identify the name 

and title of the relevant laboratory 

employee(s) and the names, titles, and 

employer(s) of all individuals outside of the 

laboratory to whom they report. 

The proposed rule also would 

establish requirements for CPSC 

acceptance of the accreditation of 

laboratories that are owned or 

controlled by a government. The 

additional requirements for this type of 

laboratory include a description, which 

may be in the form of a diagram, that 

illustrates relationships with other 

entities, such as government agencies 

and joint venture partners, and 

answering questions that will be used 

by the CPSC to determine whether it 

meets the statutory requirements for 

acceptance of its accreditation. The 

laboratory must also provide a copy of 

an executed memorandum addressed to 

all staff members and displayed for staff 

reference stating the laboratory policy to 

reject undue influence over its testing 

results by any outside person or entity. 

The memorandum must add that 

employees are required to report 

immediately to their supervisor or other 

designated official about any attempts to 

gain undue influence and that the 

laboratory will not tolerate violations of 

its undue influence policy. Further, a 

senior officer of the laboratory must 

make attestations regarding the 

continuing accuracy of the conditions 

and policies of the laboratory. 

Laboratories that are owned by foreign 

governments do not meet the definition 

of a ‘‘small entity’’ under the Regulatory 

Flexibility Act. To date, we have 

accepted one application from a 

domestic governmental laboratory. 

There are no fees payable to the CPSC 

associated with applying for CPSC 

acceptance of accreditation. The costs of 

obtaining ISO/IEC 17025:2005 

accreditation by a signatory to the 

ILAC–MRA typically include a one-time 

application fee, an annual fee for each 

field in which the laboratory is 

accredited, and an assessment fee. 

These charges will vary somewhat 

among accreditation bodies; but 

representative charges, based on the 

published fee schedule of one 

accreditation body, are $800 for the 

initial application fee, $1,300 per field 

for the annual fee, and $135 per hour 

per assessor. A representative of an 

accreditation body stated that 

assessments can take from 1 to 5 days, 

with 2.5 days being about average. 

Based on the above discussion, a 

laboratory seeking accreditation in one 

field of testing can expect to pay around 

$4,800 in fees. The cost could be higher 

if the assessment takes more than 2.5 

days. If the laboratory is seeking 

accreditation in more than one field, 

such as chemical and mechanical 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31125 

testing, the cost will be higher because 

there will be additional fees for each 

field, and the assessment will likely take 

more time. In addition, the laboratory 

can be expected to be charged for the 

cost of the assessor’s travel, lodging, and 

meals while conducting the assessment. 

There will be some cost to the 

laboratory in terms of personnel to 

prepare documents for the assessment 

and to work with the assessors during 

the assessment. 

If a laboratory is already accredited to 

ISO/IEC 17025:2005 by an accreditation 

body that is a signatory to the ILAC– 

MRA, and the laboratory is simply 

seeking to expand its scope of 

accreditation to include specific CPSC 

tests, the cost to the laboratory will be 

substantially less. In some cases, if the 

laboratory’s scope already includes 

closely related tests, the accreditation 

body might be willing to add the CPSC 

tests to the scope without additional 

charges. In other cases, there could be 

some administrative or assessment 

charges, but these would be less than 

would be required for a full initial 

assessment. 

For most product safety rules, the 

required test methods were specified in 

the regulation that established the safety 

rule. However, in the case of the 

requirements limiting the lead content 

of children’s products, the test methods 

have been specified in the notices of 

requirements for accreditation, because 

the limits on acceptable lead were 

established in law via the CPSIA. The 

proposed rule would expand the list of 

acceptable test methods for measuring 

lead content to include the use of XRF 

for measuring the lead content of glass 

materials, crystals, and certain metals. 

Because XRF can be significantly less 

expensive than other approved test 

methods, such as inductively coupled 

plasma or atomic absorption 

spectrometry, this provision could 

lower the laboratories testing costs. 

Some or all of the cost reductions could 

be passed onto the consumer product 

manufacturers in the form of lower 

testing prices. 

ISO/IEC 17025:2005 has requirements 

for the periodic reassessment of 

accredited laboratories. We are 

addressing these requirements in the 

separate but related rulemaking on 

periodic audits. 

2. Recordkeeping Requirements 

The proposed rule would require that 

laboratories maintain certain records 

associated with the testing conducted 

for purposes of section 14(a)(2) of the 

CPSA for at least five years. The 

retention requirement would apply to 

all test reports and technical records, 

records related to subcontracted tests, 

and customer reports, if different from 

the test record, if related to tests 

conducted for purposes of section 

14(a)(2) of the CPSA. Additionally, all 

internal documents describing testing 

protocols and procedures (such as 

instructions, standards, manuals, 

guides, and reference data) that have 

applied to a test conducted for purposes 

of section 14(a)(2)of the CPSA must be 

retained for a period of at least five 

years from the date such test was 

conducted. Upon a request by the CPSC, 

the laboratory must make the records 

available to the CPSC within 48 hours. 

If the records are not in English, the 

proposed rule would require that the 

laboratory provide the CPSC with copies 

of the non-English record available to 

the CPSC within 48 hours, and the 

laboratory must make an English 

translation available within 30 days of 

a request to do so. All records must be 

legible, but they can be in electronic 

format or hardcopy, so long as they are 

readily retrievable. 

3. Grounds and Procedures for Adverse 

Actions Against CPSC-Accepted 

Laboratories 

The proposed rule also would 

establish the grounds and procedures 

that the CPSC would use to take adverse 

actions against a laboratory. Adverse 

actions would include: Denying the 

acceptance of the laboratory’s 

accreditation, suspending the 

acceptance of the laboratory’s 

accreditation for a period of time, or 

withdrawing the acceptance of the 

laboratory’s accreditation on a 

temporary or permanent basis. Grounds 

for these adverse actions would include: 

A failure to comply with CPSC 

requirements, failure to cooperate with 

the CPSC during an investigation, and 

allowing a manufacturer or other party 

to exert undue influence on the testing 

process. Among other things, the rule 

would establish the requirements for the 

notices that the CPSC must provide a 

laboratory before taking an adverse 

action, the time limits for responses by 

the laboratory to the notice, and the 

laboratory’s appeal rights. 

During an investigation of an 

allegation, some costs would be 

incurred by the laboratory for things 

such as making employees available for 

interviews with CPSC investigators, 

providing the CPSC with documents or 

records requested by the investigators, 

and allowing CPSC investigators access 

to its facilities. The cost incurred would 

depend upon the scope of the 

investigation. If the CPSC proposed an 

adverse action against the laboratory, 

the laboratory could incur some cost in 

preparing a reply to the notice, if it 

chooses to reply. The number of 

investigations of laboratories that the 

CPSC will open is not known. 

4. Summary 

Laboratories that intend to provide 

third party testing services for purposes 

of section 14(a)(2) of the CPSA will 

incur some costs to obtain CPSC 

acceptance of their accreditation. The 

costs would be low for laboratories that 

are already accredited to ISO/IEC 

17025:2005 by a body that is an ILAC– 

MRA signatory. If the laboratory is not 

already accredited to ISO/IEC 

17025:2005 by an ILAC–MRA signatory, 

it can expect to incur fees of around 

$4,800. The fees could be higher if the 

laboratory sought accreditation in more 

than one field of testing or the 

assessment took more than 2.5 days. If 

the CPSC opened an investigation of the 

laboratory, the laboratory would likely 

incur some costs in connection with the 

investigation. 

As noted, the requirements in this 

proposed rule would apply only to 

those laboratories that intend to provide 

third party testing services for purposes 

of section 14(a)(2) of the CPSA. The 

only laboratories that are expected to 

provide those services are those that 

expect to receive sufficient revenue 

from providing the testing to justify 

accepting the requirements as a business 

decision. Laboratories that do not expect 

to receive sufficient revenue from these 

services to justify accepting these 

requirements would not be expected to 

pursue accreditation for this purpose. 

Therefore, one would not expect the 

requirements to have a significant 

adverse impact on a substantial number 

of laboratories. 

F. Federal Rules That Duplicate, 

Overlap, or Conflict With the Proposed 

Rule 

We have not identified any federal 

rules that duplicate, overlap, or conflict 

with the proposed rule. 

G. Significant Alternatives Considered 

The RFA directs agencies to describe 

significant alternatives to the proposed 

rule that would minimize the significant 

economic impacts on small entities, 

while accomplishing the agency’s 

objectives. We considered two 

alternatives to provisions in the 

proposed rule. One alternative was for 

the CPSC to accept the accreditation of 

laboratories that had been accredited by 

bodies other than just those that are 

signatories to the ILAC–MRA. The 

second alternative involved accepting 

XRF test methods for determining lead 


srobinson on DSK4SPTVN1PROD with PROPOSALS2
31126 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

content in paint, children’s metal 

jewelry, and children’s metal products. 

1. Accepting Accreditations by Bodies 

That Are Not ILAC–MRA Signatories 

Comments were received in response 

to several notices of requirements that 

the CPSC should accept the 

accreditation of laboratories that had 

been accredited by organizations or 

accreditation bodies that are not 

signatories to the ILAC–MRA. Some of 

the organizations not affiliated with the 

ILAC–MRA, that were suggested by 

commenters, are the American 

Industrial Hygiene Association (AIHA), 

the National Lead Laboratory 

Accreditation Program (NLLAP), the 

National Environmental Laboratory 

Accreditation Conference (NELAC), and 

accreditation bodies that are members of 

the National Cooperation for Laboratory 

Accreditation (NACLA). 

If we accepted the accreditation of 

laboratories that were accredited by 

these other organizations, it would 

reduce the cost of obtaining CPSC 

acceptance for those laboratories that 

are accredited by the non- ILAC–MRA 

bodies. Under the proposed rule, to gain 

CPSC acceptance of their accreditation, 

these laboratories would have to seek 

additional accreditation by a body that 

is a signatory to the ILAC–MRA. It is not 

known how many laboratories that are 

accredited by nonsignatories to the 

ILAC–MRA intend to offer conformity 

assessment testing services to 

manufacturers or private labelers of 

children’s products for purposes of 

section 14(a)(2) of the CPSA. 

We recognize that there are other 

laboratory accreditation organizations or 

accreditation body cooperations, and we 

realize that some of these organizations 

may adhere to similar rules and 

standards (but with some distinctions) 

as those established in the ILAC–MRA 

signatory program. However, CPSC 

designations to such organizations 

would not meet all of the objectives we 

had when we established, as a baseline 

accreditation requirement, accreditation 

by a body that was a signatory to the 

ILAC–MRA. Moreover, we sought to 

designate a program that operated and 

was accepted on a broad, multinational 

level and that could immediately bring 

on board a large number of accreditation 

bodies and avoid designating 

accreditation programs or entities that 

were recognized only in specific 

regions, nations, or localities. In the 

absence of establishing conditions for 

accreditation bodies, any person or 

entity can claim to be able to accredit 

laboratories to ISO/IEC 17025:2005, 

regardless of their qualifications to do 

so. It should also be noted that the 

AIHA, one of the suggested alternative 

accreditation bodies, is now a signatory 

to the ILAC–MRA. 

2. Alternative Test Methods for Lead 

The CPSC has received a number of 

requests to allow more extensive use of 

XRF analysis in testing related to lead 

because XRF analysis is significantly 

less expensive than the other test 

methods for lead content. 

Based on its continuing research of 

testing methodologies, the Commission 

has approved the use of certain XRF 

methods for determining the lead 

content of homogenous polymer 

components and paints, and the 

proposed rule would allow, in addition, 

the use of certain XRF methods for 

determining the lead content of glass 

materials, crystals, and certain metals. 

However, for other materials, CPSC staff 

has not determined that XRF is as 

effective, precise, and reliable as the 

approved methods. Therefore, the 

proposed rule does not expand the 

approved use of XRF to cover all 

materials or substances. We continue to 

evaluate improvements in technology 

and methods on an ongoing basis. 

3. Other Potential Alternatives 

The RFA directs agencies to consider 

some specific alternatives to a proposed 

rule including: 

1. The establishment of different 

compliance or reporting requirements for 

small entities or timetables that take into 

account the resources available to small 

entities; 

2. Clarification, consolidation, or 

simplification of compliance and reporting 

requirements for small entities; 

3. Use of performance rather than design 

standards; and 

4. Exemption for certain or all small 

entities from coverage of the rule, in whole 

or part. 

Other than the alternatives 

specifically discussed above (regarding 

accreditation by bodies that are not 

signatories to the ILAC–MRA and 

alternative testing methods for lead 

content), we did not identify any 

significant alternatives that also would 

meet the agency’s objectives and fulfill 

its obligations under the CPSA, as 

amended by the CPSIA. However, we 

welcome comments suggesting other 

alternatives that could reduce the 

burden on small entities, while fulfilling 

the agency’s objectives. 

VI. Paperwork Reduction Act 

This proposed rule contains 

information collection requirements that 

are subject to public comment and 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520) (PRA). We describe the provisions 

in this section of the document with an 

estimate of the annual reporting burden. 

Our estimate includes the time for 

completing the application to become a 

CPSC-accepted laboratory (CPSC Form 

223), including uploading the 

accompanying documents that would be 

required under this rule; for complying 

with the proposed recordkeeping 

requirements; for submitting the 

information that would be necessary to 

discontinue voluntarily as a CPSCaccepted laboratory; and for supplying 

the accompanying documents that 

would be required at audit. 

In particular, we invite comments on 

the following: (1) Whether the collection 

of information is necessary for the 

proper performance of the CPSC’s 

functions, including whether the 

information will have practical utility; 

(2) the accuracy of the CPSC’s estimate 

of the burden of the proposed collection 

of information, including the validity of 

the method and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to reduce the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Requirements Pertaining to Third 

Party Conformity Assessment Bodies 

Description: The proposed rule would 

establish the requirements pertaining to 

the laboratories that are authorized to 

test children’s products in support of 

the certification required by section 

14(a)(2) of the CPSA, as amended by 

section 102(a) of the 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 laboratory, and it also 

would address adverse actions against 

CPSC-accepted laboratories. In addition, 

the proposed rule would amend the 

audit requirements for laboratories. 

Description of Respondents: Testing 

laboratories. 

We estimate the burden of this 

collection of information as follows: 

There are no capital costs or operating 

and maintenance costs associated with 

this collection of information. 

Our estimates are based on the 

following: A laboratory desiring to have 

its accreditation accepted by the CPSC 

first must submit an application, CPSC 

Form 223. CPSC Form 223 is already an 

OMB-approved collection of 

information, control number 3041–0143, 


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which expires on July 31, 2013. In that 

approved collection, we estimated that 

it would take respondents (applicant 

laboratories) one hour to complete the 

form, which includes uploading the 

‘‘baseline documentation’’ required of 

all applicants: the accreditation 

certificate, and statement of scope. 

The proposed rule, if finalized as 

written, would necessitate changes to 

CPSC Form 223. For purposes of this 

PRA estimate, we assume the rule will 

be finalized as written. To estimate the 

paperwork burden associated with the 

application, we are beginning with the 

1-hour time estimate already approved 

under control number 3041–0143, and 

adding to the one hour estimate, the 

time we estimate it will take or an 

applicant laboratory to comply with the 

application requirements that would be 

newly imposed as a result of this rule. 

The proposed rule would require 

applicant laboratories to attest to a 

variety of facts concerning their 

ownership and legal relationships, to 

determine whether the laboratory 

should be considered an applicant for 

firewalled or governmental status. Each 

characteristic contained in § 1112.11(b) 

that indicates a firewalled laboratory, 

would be reflected in a statement to 

which an applicant laboratory would 

need to attest with a ‘‘yes’’ or ‘‘no’’ 

answer. Similarly, each characteristic 

indicating a governmental laboratory, as 

contained in § 1112.11(c), would be 

reflected in a statement to which an 

applicant laboratory would need to 

attest with a ‘‘yes’’ or ‘‘no’’ answer. We 

surveyed less than nine CPSC-accepted 

laboratories, and we asked them how 

long it took them to complete the 

attestation portion of the current CPSC 

Form 223. The average of the estimates 

provided was three minutes. This 

proposed rule would expand 

significantly the list of characteristics 

indicating ‘‘governmental’’ or 

‘‘firewalled’’ status, as compared to the 

current CPSC Form 223. We estimate 

that the additional attestation 

requirements will take applicants five 

times longer than the current attestation 

section on CPSC Form 223. 

Accordingly, we estimate that it would 

take applicants an additional 15 

minutes to complete CPSC Form 223. 

Thus, the total time estimated to comply 

with proposed § 1112.13(a) is 75 

minutes per respondent. Based on our 

experience with the laboratory program 

to date, we estimate that there will be 

a total of 450 laboratories whose 

accreditations are accepted by the CPSC 

after an initial period of about four 

years. To predict the annual burden, we 

divided the number of laboratories by 

the initial period, to arrive at an 

estimated 113 laboratories per year with 

the 75-minute burden. 

Proposed § 1112.13(a)(1) would 

require CPSC-accepted laboratories to 

submit a new CPSC Form 223 whenever 

information previously submitted on the 

form changes. Based on our experience 

operating the laboratory program, to 

date, only about 1 percent of 

laboratories per year need to update 

their information, and the information 

changes, thus far, have been limited to 

items such as a contact name. A 

laboratory will not need to fill out an 

entirely new CPSC Form 223 to submit 

new information; the laboratory can 

access its existing CPSC Form 223 via 

the laboratory application program on 

the CPSC Web site and change only 

those elements that are in need of 

updating. We estimate that it will take 

a laboratory that needs to update its 

information 15 minutes to do so. 

The proposed rule, at § 1112.13(b)(2), 

would require applicant firewalled 

laboratories to submit six documents 

concerning their relationship to the 

manufacturer in addition to their 

policies on undue influence. First, an 

applicant firewalled laboratory must 

submit their established policies and 

procedures addressing undue influence; 

that the CPSC will be notified 

immediately if there is an attempt at 

undue influence; and that allegations of 

undue influence may be reported 

confidentially to the CPSC. Because 

applicant laboratories must be 

accredited to ISO/IEC 17025:2005, we 

know that the laboratories already have 

certain policies and procedures in place 

concerning undue influence. However, 

those policies and procedures will not 

address reporting attempts at undue 

influence to the CPSC and that such 

reports to the CPSC may be confidential. 

Therefore, we estimate that a laboratory 

will need to amend its policies and 

procedures to include these CPSCrelated topics. Based on our experience 

with firewalled laboratory applications, 

to date, we estimate that it will take 

applicants two hours to develop these 

additional policies. The experience of 

CPSC staff working on firewalled 

laboratory applications indicates that 

often applicants choose to submit draft 

amended policies and procedures for 

feedback prior to finalizing the 

documents. To err on the side of 

overestimating, rather than 

underestimating the burden, we will 

assume that all firewalled applicants 

will submit draft documents, and we 

estimate that applicants will spend an 

additional hour revising and finalizing 

those documents after CPSC staff’s 

initial review. Therefore, we estimate 

that laboratories will spend 3 hours 

creating these policies and procedures. 

In terms of the time it will take an 

applicant to upload the policies and 

procedures once they exist, we estimate 

eight minutes. This estimate is based 

partly on the results of a survey of fewer 

than nine laboratories that we asked to 

estimate the amount of time it took to 

upload the baseline documents 

(accreditation certificate and statement 

of scope). On average, it took an 

applicant four minutes to locate and 

upload the two documents. Again, 

based on our experience with firewalled 

laboratory applicants, to date, we 

estimate that the required policies and 

procedures will be reflected in two 

documents (e.g., a quality manual and a 

procedures guide), each of which will 

take the estimated four minutes to locate 

and upload into the CPSC laboratory 

application system. To account for 

submitting a draft version first, to be 

followed by a final version, we doubled 

the 4 minute estimate. 

The second submission that the 

proposed rule would require of 

firewalled applicants is training 

documents showing how employees are 

trained annually on the policies and 

procedures just described (see 

§ 1112.11(b)(2)(i)). Again, laboratories 

will already have training documents, 

but those documents will need to be 

amended to reflect CPSC-related 

policies (e.g., laboratory staff may report 

allegations of undue influence 

confidentially to the CPSC). Following 

the same reasoning that we applied to 

laboratories that amend their policies 

and procedures, we estimate that it will 

take an applicant firewalled laboratory 

three hours to create the necessary 

training documents. Following the same 

reasoning that we applied to the time it 

would take to upload the policies and 

procedures, we estimate that it will take 

a firewalled laboratory applicant eight 

minutes to locate and upload the 

necessary training documents. 

The third submission the proposed 

rule would require firewalled laboratory 

applicants to furnish training records 

showing that laboratory staff were 

trained on the policies and procedures 

described above (see § 1112.11(b)(2)(i)). 

While we understand that laboratories 

maintain training records in the normal 

course of doing business, we 

acknowledge that it is unlikely that all 

laboratories routinely maintain records 

that include all of the elements that 

would be required under this rule. For 

example, while some laboratories may 

have employees sign in at each training, 

other laboratories may not. As another 

example, while some laboratories may 

record who conducted the training, 


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31128 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

others may not. To account thoroughly 

for the burden that would be imposed 

by this rule, we estimate that it will take 

each laboratory one hour to create the 

training records that would be required 

under this rule; this one hour is 

intended to account for any detail of the 

training that a laboratory would record 

for compliance with this rule that the 

laboratory otherwise would not record. 

In terms of the time it takes to locate 

and upload the training records, we 

assume that some laboratories will 

maintain the requisite information in 

more than two documents. Based on the 

survey results described previously, 

which indicated that it took an average 

of four minutes for respondents to locate 

and upload two documents, we estimate 

that the burden associated with locating 

and uploading the training documents 

requirement is four minutes. 

The fourth submission required of 

firewalled laboratory applicants is an 

organizational chart of the laboratory. 

We assume that a laboratory will 

already have such a document, so the 

time it would take to comply with this 

requirement merely would be the time 

it would take to locate and upload the 

chart. Based on the earlier estimate of 

four minutes for two documents and 

because this is only one document, we 

estimate the burden associated with this 

requirement to be two minutes. 

Similarly, the fifth submission 

required of firewalled laboratory 

applicants is an organizational chart of 

the broader organization, indicating 

how the laboratory fits into the 

manufacturing company structure. 

Again, we assume that the laboratory 

will already have access to such a 

document that exists in the normal 

course of the manufacturer’s and 

laboratory’s business. Therefore, the 

only burden associated with this 

proposed requirement would be the 

time it takes for the laboratory to locate 

and upload the chart. Based on the same 

reasoning applied for the last 

organizational chart, we estimate the 

burden associated with submitting the 

broader organization’s chart to be two 

minutes. 

The sixth submission that would be 

required of firewalled laboratory 

applicants is a list of laboratory staff 

that have reporting relationships outside 

the laboratory. We assume, for PRA 

purposes, that this document has not 

been created in the normal course of the 

laboratory’s business. We do not 

anticipate that there will be many 

laboratory employees with outside 

reporting relationships. Thus, we 

estimate that this will be a short list. 

Based on similar lists we have seen from 

prior firewalled laboratory applicants, 

we estimate that it will take a laboratory 

one hour to create this list. Using the 

same reasoning as applied already, we 

estimate that it will take a laboratory 

two minutes to locate and upload this 

document. 

Therefore, based on the above 

analysis, we estimate that it will take a 

firewalled laboratory applicant about 

8.4 hours to comply with the proposed 

requirements in § 1112.13(b)(2) (188 

min. for policies and procedures + 188 

min. for training documents + 64 min. 

for training records + 2 min. for 

laboratory organizational chart + 2 min. 

for broader organizational chart + 62 

min. for the list of staff with outside 

reporting relationship = 506 min.; 506 

min./60 min. in each hour = 8.4 hours). 

Proposed § 1112.13(c)(2) addresses 

the four additional application 

requirements for governmental 

laboratories. The first requirement 

would be that a governmental laboratory 

applicant must submit a description, 

which may be in the form of a diagram, 

which illustrates the laboratory’s 

relationships with other entities, such as 

government agencies and joint ventures. 

Based on the response from a 

governmental laboratory whose 

accreditation is accepted by the CPSC, 

the time required for this is estimated at 

one hour. 

Second, a governmental laboratory 

applicant would be required to respond 

to a questionnaire concerning the 

criteria for governmental laboratories; 

the criteria are statutory in origin, but 

they appear at § 1112.13(c)(1) of the 

proposed rule. Based on our experience 

with governmental laboratory 

applications, to date, we estimate that it 

takes each applicant one hour to 

respond to this questionnaire. 

Third, proposed § 1112.13(c)(2)(iii) 

would require a governmental 

laboratory applicant to submit a copy of 

an executed memorandum addressing 

undue influence. Our experience with 

governmental laboratory applicants 

suggests that it will take 0.5 hours to 

complete the memorandum. Therefore, 

we tentatively assign an estimate of 0.5 

hours to complete this task. 

Fourth, a senior officer of the 

governmental laboratory applicant 

would be required to attest to facts and 

policies concerning the applicant. Our 

experience with governmental 

laboratory applicants suggests that it 

will take 0.5 hours to complete the 

attestation. Therefore, we tentatively 

assign an estimate of 0.5 hours to 

complete this task. 

Therefore, the total time we estimate 

that it will take for a governmental 

laboratory applicant to comply with the 

proposed requirements in 

§ 1112.13(c)(2), is 3 hours (1 hour for the 

laboratory relationships description + 1 

hour for responding to the questionnaire 

+ 0.5 hours to complete the 

memorandum addressing undue 

influence + 0.5 hours for the attestation 

of facts and policies = 3 hours). 

Proposed § 1112.25(a) addresses 

recordkeeping requirements. We would 

require that laboratories maintain all 

test reports and technical records 

related to tests conducted for purposes 

of section 14 of the CPSA for at least 

five years. It is our understanding that 

laboratories maintain these records in 

the normal course of their business. 

However, we would also require that 

when a test conducted for purposes of 

section 14 of the CPSA is subcontracted, 

the prime contractor’s report must 

clearly identify which test(s) was 

performed by a CPSC-accepted 

laboratory acting as a subcontractor, and 

the test from the subcontractor must be 

appended to the prime contractor’s 

report. We assume, for PRA purposes, 

that those requirements may not be 

satisfied in the normal course of a 

laboratory’s business. Based upon 

responses received from laboratories we 

surveyed, we estimate that on average, 

a laboratory conducts 10,188 tests for 

purposes of section 14 of the CPSA 

annually. Based on our experience with 

the laboratory program, to date, we 

estimate that 5 percent of laboratories 

will subcontract tests to other CPSCaccepted laboratories. It is difficult to 

estimate exactly how many tests will be 

subcontracted, but for current purposes, 

we will estimate that of the laboratories 

that subcontract, they will subcontract 

25 percent of their tests. To comply with 

the proposed recordkeeping 

requirements related to subcontracted 

tests, we estimate that a laboratory will 

spend five minutes locating and 

amending a test report to indicate 

clearly that one of the test(s) supporting 

the test report has been subcontracted. 

We estimate that it will take 2 minutes 

for the laboratory to append the 

subcontracted report to the main report 

(either electronically append, or append 

hard copies of the reports [e.g., staple]). 

Therefore, we estimate that it will take 

a laboratory seven minutes to comply 

with this proposed recordkeeping 

requirement. Given the number of 

laboratories that have already been 

accepted by the CPSC, and based on our 

experience with the rate of new 

successful applications, we predict that 

the total number of laboratories will be 

450. Five percent of 450 laboratories is 

23 laboratories. Twenty-five percent of 

10,188 tests is 2,547 tests. If 23 

laboratories subcontract 2,547 tests per 


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year, that is a total of 58,581 

subcontracted tests per year. Seven 

minutes times 58,581 subcontracted 

tests produces an estimate of 410,067 

minutes, or approximately 6,834 hours 

per year, to comply with the 

recordkeeping requirement proposed at 

§ 1112.25(a)(2). 

Proposed § 1112.25(a)(3) would 

require that if a laboratory, after 

conducting a test, chooses to send a 

report to the customer different from the 

laboratory test report, the laboratory 

must maintain the report sent to the 

customer for five years. Any report that 

falls within this requirement would be 

a report that the laboratory has created 

in the normal course of its business, and 

thus, is not part of the burden associated 

with this proposed rule. 

We also would require laboratories to 

maintain any and all internal 

documents describing testing protocols 

and procedures, such as instructions 

and manuals, for a period of five years. 

Again, these documents would exist as 

part of the laboratory’s normal business 

activity so that it would not be part of 

the burden imposed by this proposed 

rule. 

Proposed § 1112.29(a) would explain 

that a CPSC-accepted laboratory may 

voluntarily discontinue its participation 

with the CPSC at any time, by 

submitting a written notice to the CPSC, 

and the proposed rule would detail the 

information that must be included in 

the notice. In the three years that we 

have been operating the laboratory 

program, six laboratories have 

voluntarily discontinued their 

participation with us. To err on the side 

of overestimating, rather than 

inaccurately underestimating the 

burden, we will assume that six 

laboratories will voluntarily discontinue 

their participation each year. We 

propose to require five elements for the 

voluntary discontinuance notice, 

including the name of, and contact 

information for, the laboratory, scope of 

the discontinuance, and the beginning 

date of the discontinuance. Based on 

our experience with the laboratory 

program, to date, we estimate that it 

would take a laboratory one hour to 

prepare and send this notice of 

discontinuance. Because we estimate 

that six laboratories per year will submit 

such a notice, the total annual burden 

associated with § 1112.29(a) is estimated 

to be six hours per year. 

The last section of this proposed rule 

that imposes paperwork burdens is a 

section related to audits. The final audit 

rule appears elsewhere in this issue of 

the Federal Register. Here, we are 

proposing to amend the definition of 

‘‘audit,’’ to include in the definition the 

requirement that all laboratories submit 

at audit, whatever accompanying 

documentation would be required if 

they were submitting an initial 

application. Because the CPSC portion 

of the audit is required no less than 

once every two years, we estimate that 

50 percent of laboratories will go 

through an audit each year. Based on 

the number of independent laboratories 

that have already been accepted by the 

CPSC and our experience with the rate 

of new successful applications, we 

predict that the total number of 

independent laboratories will be 365. 

Half of those, or 183 laboratories, will be 

audited annually. As noted above, based 

on results from a survey of fewer than 

nine laboratories, it takes applicants an 

average of four minutes to locate and 

upload their accreditation certificate 

and statement of scope. Therefore, we 

estimate that independent labs will 

spend approximately 12.2 hours 

complying with this proposed 

amendment annually (183 laboratories × 

4 minutes = 732 min. annually; 732 

min./60 minutes per hour = 12.2 hours). 

With regard to the burden associated 

with proposed § 1112.13(b)(2), we 

estimated that it would take a firewalled 

laboratory applicant 8.4 hours to submit 

the accompanying documentation 

required with their initial application 

for CPSC acceptance. Seven hours of 

that time was allotted for laboratories to 

create documents specifically required 

for testing children’s products for 

purposes of section 14 of the CPSA. The 

laboratories will not need to create those 

documents again at audit, however. 

Therefore, instead of the three hours we 

estimated that firewalled laboratories 

would spend developing the policies 

and procedures that would be required 

under § 1112.13(b)(2)(i), we estimate, for 

audit purposes, that laboratories will 

spend one hour reviewing and updating 

those policies and procedures. 

Similarly, instead of the three hours we 

projected that laboratories would need 

for developing the training documents 

under § 1112.13(b)(2)(ii), we estimate 

that laboratories will spend one hour 

reviewing and updating those 

documents at audit. Instead of the one 

hour we estimated laboratories would 

spend creating the list of employees 

with outside relationships that would be 

required under § 1112.13(b)(2)(vi), we 

estimate laboratories will spend 20 

minutes reviewing and updating that 

list at audit. Accordingly, instead of the 

506 minutes we estimated that a 

firewalled laboratory would spend in 

support of submitting the accompanying 

documentation at the time of their 

initial application for CPSC acceptance, 

we estimate that a laboratory will spend 

226 minutes in support of submitting 

the accompanying documentation at 

audit (506 min. ¥ 120 min. for policies 

and procedures ¥ 120 min. for training 

documents ¥ 40 min. for list of 

employees and outside interests = 226 

min.). Based on the number of 

firewalled laboratories that have already 

been accepted by the CPSC and our 

experience with the rate of new 

successful applications, we predict that 

the total number of firewalled 

laboratories will be 35. Half of those, or 

18, will be audited annually. If half of 

the firewalled laboratories spend 226 

minutes to comply with this aspect of 

audit annually, that is an annual 

paperwork burden of 4,068 minutes, or 

68 hours (18 laboratories × 226 minutes 

= 4,068 minutes annually; 4,068 

minutes/60 minutes per hour = 

approximately 68 hours). 

With regard to the burden associated 

with proposed § 1112.13(c)(2), we 

estimated that it would take a 

governmental laboratory applicant three 

hours to submit the accompanying 

documentation required when they 

initially apply for CPSC acceptance. We 

estimated that one hour would be 

required to develop a description, 

which may be in the form of a diagram, 

which illustrates the laboratory’s 

relationships with other entities, such as 

government agencies and joint ventures. 

The laboratories will not need to create 

the diagrams or documents again at 

audit, however. Therefore, instead of the 

one hour we estimated that 

governmental laboratories would spend 

developing a description or diagram that 

would be required under 

§ 1112.13(c)(2), we estimate, for audit 

purposes, that laboratories will spend 

10 minutes reviewing and updating the 

description or diagram. Similarly, 

instead of the one hour estimated for 

responding to the questionnaire that 

would be required under 

§ 1112.13(c)(1), we estimate laboratories 

that will spend 20 minutes reviewing 

the document at audit. Instead of the 30 

minutes we estimated that laboratories 

would spend creating a memorandum 

addressing undue influence that would 

be required under § 1112.13(c)(2)(iii), 

we estimate laboratories will spend 20 

minutes reviewing and updating that 

memorandum at audit. A CPSCaccepted governmental laboratory stated 

that it took 30 minutes to complete the 

attestation at audit. Instead of the 30 

minutes we estimated that a senior 

official would spend developing an 

attestation to facts and policies 

concerning the applicant, as required 

under § 1112.13(c)(2)(iv), we estimate 


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31130 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

that laboratories will spend 10 minutes 

reviewing the attestation. Accordingly, 

instead of the 180 minutes we estimated 

that a governmental laboratory would 

spend in support of submitting the 

accompanying documentation at the 

time of their initial application, we 

estimate that a laboratory will spend 60 

minutes in support of submitting the 

accompanying documentation at audit 

(10 min. reviewing the description or 

diagram + 20 min. reviewing the 

questionnaire + 20 min. reviewing the 

undue influence memorandum + 10 

min. reviewing the attestation = 60 

minutes). Based on the number of 

governmental laboratories that have 

already been accepted by the CPSC, as 

well as our experience with the rate of 

new successful applications, we predict 

that the total number of governmental 

laboratories will be 50. Half of those, or 

25, will be audited annually. If 25 

laboratories spend 60 minutes to 

comply with this aspect of audit 

annually, that is an annual paperwork 

burden of 1,500 minutes, or about 25 

hours (25 laboratories × 60 minutes = 

1500 minutes annually; 1500 minutes/ 

60 minutes per hour = 25 hours). 

Therefore, we estimate that the total 

paperwork burden associated with our 

proposed amendment to the definition 

of audit will be about 105 hours. 

Finally, we estimate that the total 

paperwork burden associated with this 

rule will be 7,202 hours. Table 2 

summarizes the estimates and the total 

paperwork burden associated with this 

rule. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN

16 CFR Section (proposed) Number of 

respondents 

Frequency of responses, percent Total annual 

responses 

Minutes per 

response 

Total burden, in 

hours 

§ 1112.13(a), Baseline documents— 

CPSC Form 223 and Uploading Accreditation Certificate and Statement of Scope.

450 ....................... 25% per year, for 

4 years.

113 ....................... 75 minutes ........... 141 hours per 

year. 

§ 1112.13(a)(1), Laboratory update of 

CPSC Form 223, whenever any information previously supplied on 

the form changes.

450 ....................... 1% per year ......... 5 ........................... 15 minutes ........... 1.25 hours per 

year. 

1112.13(b)(2), Additional requirements for firewalled applicants (6 

documents to upload).

35 ......................... 25% per year, for 

4 years.

9 ........................... 506 minutes (8.4 

hours).

76 hours per year. 

§ 1112.13(c)(2), Additional requirements for governmental lab applicants (4 requirements—upload description/diagram; respond to questionnaire; execute and submit copy 

of memorandum; and complete the 

attestation).

50 ......................... 25% per year, for 

4 years.

13 ......................... 180 minutes (3 

hours).

39 hours per year. 

§ 1112.25(a)(2), Recordkeeping requirements for subcontracted test 

reports.

23 (5% of 450 laboratories).25% of tests subcontracted per 

year (10,188 

tests per year, 

per laboratory).

58,581 tests per 

year that are 

subcontracted.

7 minutes ............. 6,834 hours per 

year. 

§ 1112.29(a), Submit notification of 

voluntary discontinuance in writing, 

include 5 items.

6 ........................... 100% .................... 6 ........................... 60 minutes ........... 6 hours per year. 

§ 1112.35, Adding ‘‘and accompanying documentation’’ to the definition of Audit.

A. Independent (baseline documents) A. 365 Independent laboratories.50% per year ....... A. 183 Independent laboratories.A. 4 minutes ......... A. 12.2 hours per 

year (732 minutes per year). 

B. Firewalled laboratories ................... B. 35 Firewalled 

laboratories.

.............................. B 18 Firewalled 

laboratories.

B. 226 minutes ..... B. 68 hours per 

year (4068 minutes per year). 

C. Governmental laboratories ............. C. 50 Governmental laboratories............................... C. 25 Governmental laboratories.C. 60 minutes ....... C. 25 hours per 

year (1,500 minutes per year). 

Total Burden ................................ .............................. .............................. .............................. .............................. 7,202 hours. 

In compliance with the PRA, we have 

submitted the information collection 

requirements of this rule to OMB for 

review. Interested persons are requested 

to fax comments regarding information 

collection by June 25, 2012, to the Office 

of Information and Regulatory Affairs, 

OMB (see ADDRESSES). 

VII. Environmental Considerations 

The proposed rule falls within the 

scope of the Commission’s 

environmental review regulations at 16 

CFR 1021.5(c)(1), which provide a 

categorical exclusion from any 

requirement for the agency to prepare an 

environmental assessment or 

environmental impact statement for 

product certification rules. 

VIII. Executive Order 12988 

Executive Order 12988 (February 5, 

1996), requires agencies to state in clear 

language the preemptive effect, if any, of 

new regulations. The proposed 

regulation would be issued under 

authority of the CPSA and CPSIA. The 

CPSA provision on preemption appears 

at section 26 of the CPSA. The CPSIA 

provision on preemption appears at 

section 231 of the CPSIA. The 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31131 

preemptive effect of this rule would be 

determined in an appropriate 

proceeding by a court of competent 

jurisdiction. 

IX. Effective Date 

The Commission proposes that any 

final rule based on this proposed rule 

become effective 90 days after its date 

of publication in the Federal Register. 

The requirements for CPSC 

acceptance of the accreditation of a 

third party conformity assessment body 

under the final rule may differ from the 

requirements currently in effect. In 

particular, CPSC Form 223 may change, 

as may the accompanying documents 

required with an application. The 

Commission proposes to begin applying 

any new application requirements, 

including requirements for 

accompanying documents, the first time 

after the publication of the final rule 

that a laboratory submits a CPSC Form 

223. For CPSC-accepted laboratories, 

their first submission of CPSC Form 223 

after the 1112 final rule publishes 

would likely occur at audit. 

List of Subjects 

16 CFR Part 1112 

Administrative practice and 

procedure, Audit, Consumer protection, 

Reporting and recordkeeping 

requirements, Third party conformity 

assessment body. 

16 CFR Part 1118 

Administrative practice and 

procedure, Consumer protection, 

Investigations. 

For the reasons discussed in the 

preamble, the Consumer Product Safety 

Commission proposes to amend 16 CFR 

part 1112, as added elsewhere in this 

issue of the Federal Register and 

effective July 23, 2012, and 16 CFR part 

1118 as follows: 

PART 1112—REQUIREMENTS 

PERTAINING TO THIRD PARTY 

CONFORMITY ASSESSMENT BODIES 

1. The authority citation for part 1112 

continues to read as follows: 

Authority: Pub. L. 110–314, section 3, 122 

Stat. 3016, 3017 (2008); 15 U.S.C. 2063. 

2. Amend part 1112, as added 

elsewhere in this issue of the Federal 

Register and effective July 23, 2012, by 

adding § 1112.1 to read as follows: 

§ 1112.1 Purpose. 

This part defines the term ‘‘third party 

conformity assessment body’’ and 

describes the types of third party 

conformity assessment bodies that are 

accepted by the CPSC to test children’s 

products under section 14 of the CPSA. 

It describes the requirements and 

procedures for becoming a CPSCaccepted third party conformity 

assessment body; the audit requirement 

applicable to third party conformity 

assessment bodies; how a third party 

conformity assessment body may 

voluntarily discontinue participation as 

a CPSC-accepted third party conformity 

assessment body; the grounds and 

procedures for withdrawal or 

suspension of CPSC acceptance of the 

accreditation of a third party conformity 

assessment body; and how an 

individual may submit information 

alleging grounds for adverse action. 

3. Amend § 1112.3, as added 

elsewhere in this issue of the Federal 

Register and effective July 23, 2012, by: 

a. Revising the definitions of ‘‘Audit’’ 

and ‘‘CPSC,’’; and 

c. Adding definitions for ‘‘Accept 

accreditation,’’ ‘‘Commission,’’ ‘‘CPSA,’’ 

‘‘Notice of requirements,’’ ‘‘Scope,’’ 

‘‘Suspend,’’ ‘‘Third party conformity 

assessment body,’’ ‘‘Undue Influence,’’ 

and ‘‘Withdraw’’ 

The additions read as follows:. 

§ 1112.3 Definitions. 

* * * * * 

Accept accreditation means that the 

CPSC has positively disposed of an 

application by a third party conformity 

assessment body to test children’s 

products pursuant to a particular 

children’s product safety rule, for 

purposes of the testing required in 

section 14 of the CPSA. 

* * * * * 

Audit means a systematic, 

independent, documented process for 

obtaining records, statements of fact, or 

other relevant information, and 

assessing them objectively to determine 

the extent to which specified 

requirements are fulfilled. An audit, for 

purposes of this part, consists of two 

parts: 

(1) An examination by an 

accreditation body to determine 

whether the third party conformity 

assessment body meets or continues to 

meet the conditions for accreditation (a 

process known more commonly as a 

‘‘reassessment’’); and 

(2) The resubmission of the 

‘‘Consumer Product Conformity 

Assessment Body Acceptance 

Registration Form’’ (CPSC Form 223) 

and accompanying documentation by 

the third party conformity assessment 

body and the Consumer Product Safety 

Commission’s (‘‘CPSC’s’’) examination 

of the resubmitted CPSC Form 223 and 

accompanying documentation. 

Accompanying documentation includes 

the baseline documents required of all 

applicants in § 1112.13(a), the 

documents required of firewalled 

applicants in § 1112.13(b)(2), and/or the 

documents required of governmental 

applicants in § 1112.13(c)(2). 

Commission means the body of 

Commissioners appointed to the 

Consumer Product Safety Commission. 

CPSA means the Consumer Product 

Safety Act, 15 U.S.C. 2051–2089. 

CPSC means the Consumer Product 

Safety Commission as an agency. 

Notice of requirements means a 

publication that provides the minimum 

qualifications necessary for a third party 

conformity assessment body to become 

accepted to test children’s products for 

conformity with a particular children’s 

product safety rule. 

* * * * * 

Scope means the range of particular 

CPSC safety rules and/or test methods to 

which a third party conformity 

assessment body has been accredited 

and for which it may apply for CPSC 

acceptance. 

Suspend means the CPSC has 

removed its acceptance, for purposes of 

the testing of children’s products 

required in section 14 of the CPSA, of 

a third party conformity assessment 

body’s accreditation for failure to 

cooperate in an investigation under this 

part. 

Third party conformity assessment 

body means a testing laboratory. 

Undue influence means that a 

manufacturer, private labeler, 

governmental entity, or other interested 

party affects a third party conformity 

assessment body, such that commercial, 

financial, or other pressures 

compromise the integrity of its testing 

processes or results. 

Withdraw means the CPSC removes 

its prior acceptance of a third party 

conformity assessment body’s 

accreditation pursuant to a particular 

children’s product safety rule for 

purposes of the testing of children’s 

products required in section 14 of the 

CPSA. 

4. Amend part 1112, as added 

elsewhere in this issue of the Federal 

Register and effective July 23, 2012, by 

adding subpart B, to read as follows: 

Subpart B—General Requirements 

Pertaining to Third Party Conformity 

Assessment Bodies 

Sec. 

1112.11 What are the types of third party 

conformity assessment bodies? 

1112.13 How does a third party conformity 

assessment body apply for CPSC 

acceptance? 

1112.15 When can a third party conformity 

assessment body apply for CPSC 

acceptance for a particular CPSC rule 

and/or test method? 


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31132 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

1112.17 How will the CPSC respond to each 

application? 

1112.19 How does the CPSC publish 

information identifying third party 

conformity assessment bodies that have 

been accepted? 

1112.21 May a third party conformity 

assessment body use testing methods 

other than those specified in the relevant 

CPSC rule and/or test method? 

1112.23 May a CSPC-accepted third party 

conformity assessment body subcontract 

work conducted for purposes of section 

14 of the CPSA? 

1112.25 What are a third party conformity 

assessment body’s recordkeeping 

responsibilities? 

1112.27 Must a third party conformity 

assessment body allow CPSC inspections 

related to investigations? 

1112.29 How does a third party conformity 

assessment body voluntarily discontinue 

its participation with the CPSC? 

Subpart B—General Requirements 

Pertaining to Third Party Conformity 

Assessment Bodies 

§ 1112.11 What are the types of third party 

conformity assessment bodies? 

(a) Independent. Independent third 

party conformity assessment bodies are 

third party conformity assessment 

bodies that are neither 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, nor owned or 

controlled in whole or in part by a 

government; 

(b) Firewalled. A third party 

conformity assessment body must apply 

for firewalled status if: 

(1) It is owned, managed, or 

controlled by a manufacturer or private 

labeler of a children’s product; 

(i) For purposes of determining 

whether a third party conformity 

assessment body is firewalled, 

‘‘manufacturer’’ includes a trade 

association. 

(ii) A manufacturer or private labeler 

is considered to own, manage, or control 

a third party conformity assessment 

body if any one of the following 

characteristics applies: 

(A) The manufacturer or private 

labeler of the children’s product holds 

a 10 percent or greater ownership 

interest, whether direct or indirect, in 

the third party conformity assessment 

body. Indirect ownership interest is 

calculated by successive multiplication 

of the ownership percentages for each 

link in the ownership chain; 

(B) The third party conformity 

assessment body and a manufacturer or 

private labeler of the children’s product 

are owned by a common ‘‘parent’’ 

entity; 

(C) A manufacturer or private labeler 

of the children’s product has the ability 

to appoint a majority of the third party 

conformity assessment body’s senior 

internal governing body (such as, but 

not limited to, a board of directors), the 

ability to appoint the presiding official 

(such as, but not limited to, the chair or 

president) of the third party conformity 

assessment body’s senior internal 

governing body, and/or the ability to 

hire, dismiss, or set the compensation 

level for third party conformity 

assessment body personnel; or 

(D) The third party conformity 

assessment body is under a contract to 

a manufacturer or private labeler of the 

children’s product that explicitly limits 

the services the third party conformity 

assessment body may perform for other 

customers and/or explicitly limits 

which or how many other entities may 

also be customers of the third party 

conformity assessment body. 

(2) The children’s product is subject 

to a CPSC children’s product safety rule 

that the third party conformity 

assessment body requests CPSC 

acceptance to test; and 

(3) The third party conformity 

assessment body intends to test such 

children’s product made by the owning, 

managing, or controlling entity for the 

purpose of supporting a Children’s 

Product Certificate. 

(c) Governmental. Governmental third 

party conformity assessment bodies are 

owned or controlled, in whole or in 

part, by a government. For purposes of 

this part, ‘‘government’’ includes any 

unit of a national, territorial, provincial, 

regional, state, tribal, or local 

government, and a union or association 

of sovereign states. ‘‘Government’’ also 

includes domestic, as well as foreign 

entities. A third party conformity 

assessment body is ‘‘owned or 

controlled, in whole or in part, by a 

government’’ if any one of the following 

characteristics applies: 

(1) A governmental entity holds a 1 

percent or greater ownership interest, 

whether direct or indirect, in the third 

party conformity assessment body. 

Indirect ownership interest is calculated 

by successive multiplication of the 

ownership percentages for each link in 

the ownership chain; 

(2) A governmental entity provides 

any direct financial investment or 

funding (other than fee for work); 

(3) A governmental entity has the 

ability to appoint a majority of the third 

party conformity assessment body’s 

senior internal governing body (such as, 

but not limited to, a board of directors); 

the ability to appoint the presiding 

official of the third party conformity 

assessment body’s senior internal 

governing body (such as, but not limited 

to, chair or president); and/or the ability 

to hire, dismiss, or set the compensation 

level for third party conformity 

assessment body personnel; 

(4) Third party conformity assessment 

body management or technical 

personnel include any government 

employees; 

(5) The third party conformity 

assessment body has a subordinate 

position to a governmental entity in its 

external organizational structure (not 

including its relationship as a regulated 

entity to a government regulator); or 

(6) Apart from its role as regulator, the 

government can determine, establish, 

alter, or otherwise affect: 

(i) The third party conformity 

assessment body’s testing outcomes; 

(ii) The third party conformity 

assessment body’s budget or financial 

decisions; 

(iii) Whether the third party 

conformity assessment body may accept 

particular offers of work; or 

(iv) The third party conformity 

assessment body’s organizational 

structure or continued existence. 

§ 1112.13 How does a third party 

conformity assessment body apply for 

CPSC acceptance? 

(a) Baseline Requirements. Each third 

party conformity assessment body 

seeking CPSC acceptance must: 

(1) Submit a completed Consumer 

Product Conformity Assessment Body 

Registration Form (‘‘CPSC Form 223’’ or 

‘‘Application’’). In submitting a CPSC 

Form 223, the third party conformity 

assessment body must attest to facts and 

characteristics about its business that 

will determine whether the third party 

conformity assessment body is 

independent, firewalled, or 

governmental. The third party 

conformity assessment body also must 

attest that it has read, understood, and 

agrees to the regulations in this part. 

The third party conformity assessment 

body must update its CPSC Form 223 

whenever any information previously 

supplied on the form changes. 

(2) Submit the following 

documentation. 

(i) Accreditation certificate. (A) The 

third party conformity assessment body 

must be accredited to the ISO/IEC 

Standard 17025:2005(E), ‘‘General 

requirements for the competence of 

testing and calibration laboratories.’’ 

(B) The accreditation must be by an 

accreditation body that is a signatory to 

the International Laboratory 

Accreditation Cooperation-Mutual 

Recognition Arrangement (ILAC–MRA). 

(ii) Statement of scope. The third 

party conformity assessment body’s 

accreditation must include a statement 

of scope that clearly identifies each 


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CPSC rule and/or test method for which 

CPSC acceptance is sought. Although a 

third party conformity assessment body 

may include more than one CPSC rule 

and/or test method in its scope in one 

application, it must submit a new 

application if the CPSC has already 

accepted the third party conformity 

assessment body for a particular scope, 

and the third party conformity 

assessment body wishes to expand its 

acceptance to include additional CPSC 

rules and/or test methods. 

(b) Additional Requirements for 

Firewalled Third Party Conformity 

Assessment Bodies. 

(1) A third party conformity 

assessment body may be accepted as a 

firewalled third party conformity 

assessment body if the Commission, by 

order, makes the findings described in 

§ 1112.17(b). 

(2) For the Commission to evaluate 

whether an applicant firewalled third 

party conformity assessment body 

satisfies the criteria listed in 

§ 1112.17(b), and in addition to the 

baseline accreditation requirements in 

paragraph (a) of this section, a 

firewalled third party conformity 

assessment body applying for 

acceptance of its accreditation must 

submit copies of: 

(i) The third party conformity 

assessment body’s established policies 

and procedures that explain: 

(A) How the third party conformity 

assessment body will protect its test 

results from undue influence by the 

manufacturer, private labeler, or other 

interested party; 

(B) That the CPSC will be notified 

immediately 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 

(C) That allegations of undue 

influence may be reported 

confidentially to the CPSC; 

(ii) Training documents, including a 

description of the training program 

content, showing how employees are 

trained annually on the policies and 

procedures described in paragraph 

(b)(2)(i) of this section; 

(iii) Training records, including a list 

and corresponding signatures, of the 

staff members who received the training 

identified in paragraph (b)(2)(ii) of this 

section. The records must include 

training dates, location, and the name 

and title of the individual providing the 

training; 

(iv) An organizational chart(s) of the 

third party conformity assessment body 

that includes the names of all third 

party conformity assessment body 

personnel, both temporary and 

permanent, and their reporting 

relationship within the third party 

conformity assessment body; 

(v) An organizational chart(s) of the 

broader organization that identifies the 

reporting relationships of the third party 

conformity assessment body within the 

broader organization (using both 

position titles and staff names); and 

(vi) A list of all third party conformity 

assessment body personnel with 

reporting relationships outside of the 

third party conformity assessment body. 

The list must identify the name and title 

of the relevant third party conformity 

assessment body employee(s) and the 

names, titles, and employer(s) of all 

individuals outside of the third party 

conformity assessment body to whom 

they report; 

(c) Additional Requirements for 

Governmental Third Party Conformity 

Assessment Bodies. (1) The CPSC may 

accept a governmental third party 

conformity assessment body if the CPSC 

determines that: 

(i) To the extent practicable, 

manufacturers or private labelers 

located in any nation are permitted to 

choose third party conformity 

assessment bodies that are not owned or 

controlled by the government of that 

nation; 

(ii) The third party conformity 

assessment body’s testing results are not 

subject to undue influence by any other 

person, including another governmental 

entity; 

(iii) The third party conformity 

assessment body is not accorded more 

favorable treatment than other third 

party conformity assessment bodies in 

the same nation who have been 

accredited; 

(iv) The third party conformity 

assessment body’s testing results are 

accorded no greater weight by other 

governmental authorities than those of 

other accredited third party conformity 

assessment bodies; and 

(v) 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. 

(2) For the CPSC to evaluate whether 

a governmental third party conformity 

assessment body satisfies the criteria 

listed in paragraph (c)(1), and in 

addition to the baseline accreditation 

requirements in paragraph (a) of this 

section, a governmental third party 

conformity assessment body seeking 

CPSC-accepted status must submit: 

(i) Description. A description 

illustrating the relationships with other 

entities, such as government agencies 

and joint ventures partners. The 

description may be in the form of a 

diagram; 

(ii) Responses to questionnaires. The 

CPSC will provide a governmental third 

party conformity assessment body 

applicant with a questionnaire and will 

provide a separate questionnaire to the 

affiliated governmental entity; 

(iii) Executed memorandum. A copy 

of an executed memorandum addressing 

undue influence; 

(A) The memorandum must be: 

(1) Addressed to all staff of the third 

party conformity assessment body; 

(2) On company letterhead; 

(3) From senior management; 

(4) In the primary written language 

used for business communication in the 

area where the third party conformity 

assessment body is located; if that 

language is different than English, an 

English translation of the executed 

memorandum must also be provided to 

the CPSC; 

(5) Displayed prominently for staff 

reference for as long as the accreditation 

of the third party conformity assessment 

body is accepted by the CPSC; and 

(B) The memorandum must state that: 

(1) The policy of the laboratory is to 

reject undue influence by any 

manufacturer, private labeler, 

governmental entity, or other interested 

party, regardless of that person or 

entity’s affiliation with any 

organization; 

(2) Employees are required to report 

immediately to their supervisor or any 

other official designated by the third 

party conformity assessment body about 

any attempts to gain undue influence; 

and 

(3) The third party conformity 

assessment body will not tolerate 

violations of the undue influence 

policy. 

(iv) Attestation. A senior officer of the 

governmental third party conformity 

assessment body, who has the authority 

to make binding statements of policy on 

behalf of the third party conformity 

assessment body, must attest to the 

following: 

(A) The third party conformity 

assessment body seeks acceptance as a 

governmental third party conformity 

assessment body under the CPSC’s 

program of requirements for the testing 

of children’s products; 

(B) The official intends the attestation 

to be considered in support of any and 

all applications made by this third party 

conformity assessment body for 


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31134 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 

acceptance of its accreditation by the 

CPSC, including future applications 

related to additional CPSC rules and/or 

test methods; 

(C) The attestation, and any other 

document submitted in support of the 

application, is accurate in its 

representation of current conditions or 

policies at the third party conformity 

assessment body, to the best of the 

official’s knowledge, information, and/ 

or belief. The information in the 

attestation, and any other document 

submitted in support of the application, 

will be understood by the CPSC as 

continuing in its accuracy in every 

respect, until and unless notice of its 

revocation by an authorized officer of 

the third party conformity assessment 

body is received by the CPSC. The 

official understands that acceptance by 

the CPSC carries with it the obligation 

to comply with this part, in order to 

remain on the CPSC’s list of accepted 

third party conformity assessment 

bodies. The attestation is submitted as a 

condition of acceptance of this 

laboratory as a governmental third party 

conformity assessment body by the 

CPSC. 

(D) The word ‘‘government’’ in the 

attestation refers to any government 

(central, provincial, municipal, or other) 

in this third party conformity 

assessment body’s country or 

administrative area and includes stateowned entities, even if those entities do 

not carry out governmental functions. 

(E) With regard to consumer products 

to be distributed in commerce in the 

United States and subject to CPSC third 

party testing requirements, the third 

party conformity assessment body does 

not receive, and will not accept from 

any governmental entity, treatment that 

is more favorable than that received by 

other third party conformity assessment 

bodies in the same country or 

administrative area, which have been 

accepted as accredited for third party 

testing by the CPSC. More favorable 

treatment for a governmental third party 

conformity assessment body includes, 

but is not limited to, authorization to 

perform essential export-related 

functions, while competing CPSCaccepted laboratories in the same 

country or administrative area are not 

permitted to perform those same 

functions. 

(F) With regard to consumer products 

to be sold in the United States and 

subject to CPSC third party testing 

requirements, the third party conformity 

assessment body’s testing results are not 

accorded greater weight by any 

governmental entity that may be 

evaluating such results for export 

control purposes, compared to other 

third party conformity assessment 

bodies in the same country or 

administrative area, which have been 

accepted as accredited for third party 

testing by the CPSC. 

(G) The third party conformity 

assessment body has an expressed 

policy, known to its employees, that 

forbids attempts at undue influence over 

any government authorities on matters 

affecting its operations. 

(H) When a governmental third party 

conformity assessment body is owned or 

controlled by a governmental entity that 

also has any ownership or control over 

consumer product production, the 

senior officer of the applicant third 

party conformity assessment body must 

attest that the third party conformity 

assessment body will not conduct CPSC 

tests in support of a Children’s Product 

Certificate for products for export to the 

United States that have been produced 

by an entity in which that governmental 

entity holds such ownership or control 

until it has applied for and been 

accepted by the Commission as, a dual 

governmental-firewalled third party 

conformity assessment body. 

(v) Governmental entity attestation. In 

the event that the CPSC determines that 

its ability to accept a governmental third 

party conformity assessment body’s 

application is dependent upon a 

recently changed circumstance in the 

relationship between the third party 

conformity assessment body and a 

governmental entity, and/or a recently 

changed policy of the related 

governmental entity, the CPSC may 

require the relevant governmental entity 

to attest to the details of the new 

relationship or policy. 

(d) Dual firewalled and governmental 

status. A third party conformity 

assessment body that meets both the 

firewalled and the governmental criteria 

must submit applications under both 

firewalled and governmental categories. 

(e) English language. All application 

materials must be in English. 

(f) Electronic submission. The CPSC 

Form 223 and all accompanying 

documentation must be submitted 

electronically via the CPSC Web site. 

(g) Clarification and verification. The 

CPSC may require additional 

information to determine whether the 

third party conformity assessment body 

meets the relevant criteria. In addition, 

the CPSC may verify accreditation 

certificate and scope information 

directly from the accreditation body 

before approving an application. 

(h) Retraction of Application. A third 

party conformity assessment body may 

retract a submitted CPSC Form 223 any 

time before the CPSC has acted on the 

submission. A retraction will not end or 

nullify any enforcement action that the 

CPSC is otherwise authorized by law to 

pursue. 

(i) The Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain a copy 

of ISO/IEC 17025:2005(E) from the 

International Organization for 

Standardization (ISO), 1, ch. de la VoieCreuse, Case postale 56, CH–1211 

Geneva 20, Switzerland; Telephone +41 

22 749 01 11, Fax +41 22 733 34 30; 

http://www.iso.org/iso/ 

catalogue_detail.htm?csnumber=39883. 

You may inspect a copy at the Office of 

the Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone 301–504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741– 6030, 

or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

§ 1112.15 When can a third party 

conformity assessment body apply for 

CPSC acceptance for a particular CPSC rule 

and/or test method? 

(a) Once the CPSC publishes the 

requirements for accreditation to a 

particular CPSC rule and/or test 

method, a third party conformity 

assessment body may apply to the CPSC 

for acceptance to that scope of 

accreditation. An application may be 

made for acceptance of accreditation to 

more than one CPSC rule and/or test 

method. Once accepted by the CPSC, a 

third party conformity assessment body 

may apply at any time to expand the 

scope of its acceptance to include 

additional CPSC rules or test methods. 

A third party conformity assessment 

body may only issue test results for 

purposes of section 14 of the CPSA that 

fall within a scope for which the CPSC 

has accepted the third party conformity 

assessment body’s accreditation. 

(b) The CPSC has published 

previously, or in the cases of 16 CFR 

parts 1221, 1223, and 1224, and ASTM 

F 963–11 for the first time, the 

requirements for accreditation for third 

party conformity assessment bodies to 

assess conformity with the following 

CPSC rules and/or test methods: 

(1) 16 CFR part 1203, Safety Standard 

for Bicycle Helmets; 

(2) 16 CFR part 1215, Safety Standard 

for Infant Bath Seats; 

(3) 16 CFR part 1216, Safety Standard 

for Infant Walkers; 

(4) 16 CFR part 1217, Safety Standard 

for Toddler Beds; 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31135 

(5) 16 CFR part 1219, Safety Standard 

for Full-Size Baby Cribs; 

(6) 16 CFR part 1220, Safety Standard 

for Non-Full-Size Baby Cribs; 

(7) 16 CFR part 1221, Safety Standard 

for Play Yards; 

(8) 16 CFR part 1223, Safety Standard 

for Infant Swings 

(9) 16 CFR part 1224, Safety Standard 

for Portable Bedrails; 

(10) 16 CFR part 1303, Ban of LeadContaining Paint and Certain Consumer 

Products Bearing Lead-Containing Paint. 

For its accreditation to be accepted by 

the Commission to test to 16 CFR part 

1303, a third party conformity 

assessment body must have one or more 

of the following test methods referenced 

in its statement of scope: 

(i) CPSC Standard Operating 

Procedure for Determining Lead (Pb) in 

Paint and Other Similar Surface 

Coatings, CPSC–CH–E1003–09 and/or 

CPSC–CH–E1003–09.1; 

(ii) ASTM F 2853–10, ‘‘Standard Test 

Method for Determination of Lead in 

Paint Layers and Similar Coatings or in 

Substrates and Homogenous Materials 

by Energy Dispersive X-Ray 

Fluorescence Spectrometry Using 

Multiple Monochromatic Excitation 

Beams.’’ 

(11) 16 CFR part 1420, Safety 

Standard for All-Terrain Vehicles; 

(12) 16 CFR 1500.86(a)(5), Exceptions 

from Classification as a Banned Toy or 

Other Banned Article for Use by 

Children (Clacker Balls); 

(13) 16 CFR 1500.86(a)(7) and (8), 

Exceptions from Classification as a 

Banned Toy or Other Banned Article for 

Use by Children (Dive Sticks and 

Similar Articles); 

(14) 16 CFR part 1501, Method for 

Identifying Toys and Other Articles 

Intended for Use by Children Under 3 

Years of Age Which Present Choking, 

Aspiration, or Ingestion Hazards 

Because of Small Parts; 

(15) 16 CFR part 1505, Requirements 

for Electrically Operated Toys or Other 

Electrically Operated Articles Intended 

for Use by Children; 

(16) 16 CFR part 1510, Requirements 

for Rattles; 

(17) 16 CFR part 1511, Requirements 

for Pacifiers; 

(18) 16 CFR part 1512, Requirements 

for Bicycles; 

(19) 16 CFR part 1513, Requirements 

for Bunk Beds; 

(20) 16 CFR part 1610, Standard for 

the Flammability of Clothing Textiles; 

(21) 16 CFR part 1611, Standard for 

the Flammability of Vinyl Plastic Film; 

(22) 16 CFR part 1615, Standard for 

the Flammability of Children’s 

Sleepwear: Sizes 0 Through 6X (FF 3– 

71); 

(23) 16 CFR part 1616, Standard for 

the Flammability of Children’s 

Sleepwear: Sizes 7 Through 14 (FF 5– 

74); 

(24) 16 CFR part 1630, Standard for 

the Surface Flammability of Carpets and 

Rugs (FF 1–70); 

(25) 16 CFR part 1631, Standard for 

the Surface Flammability of Small 

Carpets and Rugs (FF 2–70); 

(26) 16 CFR part 1632, Standard for 

the Flammability of Mattresses and 

Mattress Pads (FF 4–72, amended); 

(27) 16 CFR part 1633, Standard for 

the Flammability (Open Flame) of 

Mattress Sets; 

(28) Lead Content in Children’s Metal 

Jewelry. For its accreditation to be 

accepted by the Commission to test for 

lead content in children’s metal jewelry, 

a third party conformity assessment 

body must have one or more of the 

following test methods referenced in its 

statement of scope: 

(i) CPSC Test Method CPSC–CH– 

E1001–08, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry)’’; 

and/or the revision CPSC Test Method 

CPSC–CH–E1001–08.1, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Children’s Metal 

Products (Including Children’s Metal 

Jewelry)’’; and/or 

(ii) Section I, ‘‘Screening Test for 

Total Pb Analysis,’’ from CPSC 

‘‘Standard Operating Procedure for 

Determining Lead (Pb) and its 

Availability in Children’s Metal 

Jewelry,’’ dated February 3, 2005; 

(29) Limits on Total Lead in 

Children’s Products: Children’s Metal 

Products. For its accreditation to be 

accepted by the Commission to test for 

total lead content in children’s metal 

products, a third party conformity 

assessment body must have one or more 

of the following test methods referenced 

in its statement of scope: CPSC Test 

Method CPSC–CH–E1001–08, 

‘‘Standard Operating Procedure for 

Determining Total Lead (Pb) in 

Children’s Metal Products (Including 

Children’s Metal Jewelry)’’; and/or the, 

revision CPSC Test Method CPSC–CH– 

E1001–08.1, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry’’; 

and/or the revision of that test method 

((Test Method CPSC–CH–E1001–08.2); 

(30) Limits on Total Lead in 

Children’s Products: Non-Metal 

Children’s Products. For its 

accreditation to be accepted by the 

Commission to test for lead content in 

non-metal children’s products, a third 

party conformity assessment body must 

have one or more of the following test 

methods referenced in its statement of 

scope: CPSC Test Method CPSC–CH– 

E1002–08, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Non-Metal Children’s Products’’; 

and/or the revision CPSC Test Method 

CPSC–CH–E1002–08.1, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Non-Metal Children’s 

Products’’; and/or the revision of that 

test method ((Test Method CPSC–CH– 

E1002–08.2); 

(31) Limits on Phthalates in 

Children’s Toys and Child Care Articles. 

For its accreditation to be accepted by 

the Commission to test for phthalates in 

children’s toys and child care articles, a 

third party conformity assessment body 

must have one or more of the following 

test methods referenced in its statement 

of scope: 

(i) CPSC Test Method CPSC–CH– 

1001–09.3, ‘‘Standard Operating 

Procedure for Determination of 

Phthalates;’’ and/or 

(ii) GB/T 22048–2008, ‘‘Toys and 

Children’s Products—Determination of 

Phthalate Plasticizers in Polyvinyl 

Chloride Plastic;’’ 

(32) ASTM International’s Standard 

Consumer Safety Specification for Toy 

Safety, F 963–11, and section 4.27 (toy 

chests) from ASTM International’s 

Standard Consumer Safety 

Specification for Toy Safety, F 963– 

07e1. The CPSC only requires certain 

provisions of ASTM F 963–11 and 

Section 4.27 of ASTM F 963–07e1 to be 

subject to third party Testing; and 

therefore, the CPSC only accepts the 

accreditation of third party conformity 

assessment bodies for testing under the 

following toy safety standards: 

(i) ASTM F 963–07e1; Section 4.27— 

Toy Chests (except labeling and/or 

instructional literature requirements) 

(ii) ASTM F 963–11 

(A) Section 4.3.5.1(2), Surface Coating 

Materials—Soluble Test for Metals 

(B) Section 4.3.5.2,Toy Substrate 

Materials 

(C) Section 4.3.6.3, Cleanliness of 

Liquids, Pastes, Putties, Gels, and 

Powders (except for cosmetics and tests 

on formulations used to prevent 

microbial degradation) 

(D) Section 4.3.7, Stuffing Materials 

(E) Section 4.5, Sound Producing 

Toys 

(F) Section 4.6, Small Objects (except 

labeling and/or instructional literature 

requirements) 

(G) Section 4.7, Accessible Edges 

(except labeling and/or instructional 

literature requirements) 

(H) Section 4.8, Projections (except 

bath toy projections) 


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(I) Section 4.9, Accessible Points 

(except labeling and/or instructional 

literature requirements) 

(J) Section 4.10, Wires or Rods 

(K) Section 4.11, Nails and Fasteners 

(L) Section 4.12, Plastic Film 

(M) Section 4.13, Folding 

Mechanisms and Hinges 

(N) Section 4.14, Cords, Straps, and 

Elastics 

(O) Section 4.15, Stability and 

Overload Requirements 

(P) Section 4.16, Confined Spaces 

(Q) Section 4.17, Wheels, Tires, and 

Axles 

(R) Section 4.18, Holes, Clearances, 

and Accessibility of Mechanisms 

(S) Section 4.19, Simulated Protective 

Devices (except labeling and/or 

instructional literature requirements) 

(T) Section 4.20.1, Pacifiers with 

Rubber Nipples/Nitrosamine Test 

(U) Section 4.20.2, Toy Pacifiers 

(V) Section 4.21, Projectile Toys 

(W) Section 4.22, Teethers and 

Teething Toys 

(X) Section 4.23.1, Rattles with Nearly 

Spherical, Hemispherical, or Circular 

Flared Ends 

(Y) Section 4.24, Squeeze Toys 

(Z) Section 4.25, Battery-Operated 

Toys (except labeling and/or 

instructional literature requirements) 

(AA) Section 4.26, Toys Intended to 

Be Attached to a Crib or Playpen (except 

labeling and/or instructional literature 

requirements) 

(BB) Section 4.27, Stuffed and 

Beanbag-Type Toys 

(CC) Section 4.30, Toy Gun Marking 

(DD) Section 4.32, Certain Toys with 

Nearly Spherical Ends 

(EE) Section 4.35, Pompoms 

(FF) Section 4.36, HemisphericShaped Objects 

(GG) Section 4.37, Yo-Yo Elastic 

Tether Toys 

(HH) Section 4.38, Magnets (except 

labeling and/or instructional literature 

requirements) 

(II) Section 4.39, Jaw Entrapment in 

Handles and Steering Wheels 

(c) The Director of the Federal 

Register approves the incorporations by 

reference in this section in accordance 

with 5 U.S.C. 552(a) and 1 CFR part 51. 

You may inspect a copy of the standards 

incorporated in this section at the Office 

of the Secretary, U.S. Consumer Product 

Safety Commission, Room 820, 4330 

East West Highway, Bethesda, MD 

20814, telephone 301–504–7923, or at 

the National Archives and Records 

Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741– 6030, 

or go to: http://www.archives.gov/

federal_register/code_of_federal_

regulations/ibr_locations.html. 

(1) ASTM F 2853–10, ‘‘Standard Test 

Method for Determination of Lead in 

Paint Layers and Similar Coatings or in 

Substrates and Homogenous Materials 

by Energy Dispersive X-Ray 

Fluorescence Spectrometry Using 

Multiple Monochromatic Excitation 

Beams.’’ 

(2) GB/T 22048–2008, ‘‘Toys and 

Children’s Products—Determination of 

Phthalate Plasticizers in Polyvinyl 

Chloride Plastic.’’ 

§ 1112.17 How will the CPSC respond to 

each application? 

(a) The CPSC staff will review each 

application and may contact the third 

party conformity assessment body with 

questions or to request submission of 

missing information. 

(b) The application of a firewalled 

third party conformity assessment body 

will be accepted by order of the 

Commission, if the Commission finds 

that: 

(1) Acceptance of the accreditation of 

the third party conformity assessment 

body would provide equal or greater 

consumer safety protection than the 

manufacturer’s or private labeler’s use 

of an independent third party 

conformity assessment body; and 

(2) The third party conformity 

assessment body has established 

procedures to ensure that: 

(i) Its test results are protected from 

undue influence by the manufacturer, 

private labeler, or other interested party; 

(ii) The CPSC is notified immediately 

of any attempt by the manufacturer, 

private labeler, or other interested party 

to hide or exert undue influence over 

test results; and 

(iii) Allegations of undue influence 

may be reported confidentially to the 

CPSC. 

(c) The CPSC will communicate its 

decision on each application in writing 

to the applicant, which may be by 

electronic mail. 

§ 1112.19 How does the CPSC publish 

information identifying third party 

conformity assessment bodies that have 

been accepted? 

The CPSC will maintain on its Web 

site an up-to-date listing of third party 

conformity assessment bodies whose 

accreditations it has accepted and the 

scope of each acceptance. The CPSC 

will update the listing regularly to 

account for changes, such as the 

addition of new CPSC rules and/or test 

methods to its scope of accreditation, 

changes to accreditation certificates, 

new addresses, as well as changes to the 

status of a third party conformity 

assessment body due to voluntary 

discontinuance, suspension, and/or 

withdrawal. 

§ 1112.21 May a third party conformity 

assessment body use testing methods 

other than those specified in the relevant 

CPSC rule and/or test method? 

If the CPSC has specified a test 

method, a third party conformity 

assessment body must use that test 

method for any tests conducted for 

purposes of section 14 of the CPSA. 

§ 1112.23 May a CSPC-accepted third 

party conformity assessment body 

subcontract work conducted for purposes 

of section 14 of the CPSA? 

(a) A CPSC-accepted third party 

conformity assessment body (which, for 

purposes of this section, also will be 

referred to as the prime contractor) may 

only subcontract work conducted for 

purposes of section 14 of the CPSA to 

other third party conformity assessment 

bodies that have been accepted by the 

CPSC for the scope necessary for the 

subcontracted work. Violation of this 

provision constitutes compromising the 

integrity of the testing process and may 

be grounds for withdrawal of the CPSC’s 

acceptance of the accreditation of the 

prime and/or subcontracting third party 

conformity assessment body. 

(b) The provisions of this part apply 

to all CPSC-accepted third party 

conformity assessment bodies, even if 

they are a prime contractor and/or a 

subcontractor. 

§ 1112.25 What are a third party 

conformity assessment body’s 

recordkeeping responsibilities? 

(a) The third party conformity 

assessment body must maintain the 

following records, which must be 

legible: 

(1) All test reports and technical 

records related to tests conducted for 

purposes of section 14 of the CPSA must 

be maintained for a period of at least 

five years from the date the test was 

conducted; 

(2) In the case of a test report for a test 

conducted by a CPSC-accepted third 

party conformity assessment body 

acting as a subcontractor, the prime 

contractor’s test report must clearly 

identify which test(s) was performed by 

a CPSC-accepted third party conformity 

assessment body acting as a 

subcontractor(s), and the test report 

from the CPSC-accepted third party 

conformity assessment body acting as a 

subcontractor must be appended to the 

prime contractor’s test report. 

(3) Where a report, for purposes of 

section 14 of the CPSA, provided by the 

third party conformity assessment body 

to a customer is different from the test 

record, the third party conformity 

assessment body also must retain the 

report provided to the customer for a 


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period of at least five years from the 

date the test was conducted. 

(4) Any and all third party conformity 

assessment body internal documents 

describing testing protocols and 

procedures (such as instructions, 

standards, manuals, guides, and 

reference data) that have applied to a 

test conducted for purposes of section 

14 of the CPSA must be retained for a 

period of at least five years from the 

date such test was conducted. 

(b) Upon request by the CPSC, the 

third party conformity assessment body 

must make any and all of the records 

required by this section available for 

inspection, either in hard copy or 

electronic form, within 48 hours. If the 

records are not in the English language, 

the third party conformity assessment 

body must make copies of the original 

(non-English language) available to the 

CPSC within 48 hours, and they must 

make an English translation of the 

records available to the CPSC within 30 

calendar days of the date the CPSC 

requested an English translation. 

§ 1112.27 Must a third party conformity 

assessment body allow CPSC inspections 

related to investigations? 

A third party conformity assessment 

body, as a condition of the continued 

CPSC-acceptance of its accreditation, 

must allow an officer or employee duly 

designated by the CPSC to enter and 

inspect the third party conformity 

assessment body for purposes of an 

investigation under this part. The CPSC 

will conduct such inspections in 

accordance with 16 CFR 1118.2. Failure 

to cooperate with such an inspection 

constitutes failure to cooperate with an 

investigation and is grounds for 

suspension under § 1112.45. 

§ 1112.29 How does a third party 

conformity assessment body voluntarily 

discontinue its participation with the 

CPSC? 

(a) A third party conformity 

assessment body may voluntarily 

discontinue participation as a CPSCaccepted third party conformity 

assessment body at any time and for any 

portion of its scope that is accepted by 

the CPSC. The third party conformity 

assessment body must notify the CPSC, 

in writing, which may be electronic. 

The notice must include: 

(1) Name, address, phone number, 

electronic mail address for the third 

party conformity assessment body and 

the person responsible for submitting 

the request; 

(2) Scope of the discontinuance; 

(3) Beginning date for the 

discontinuance; 

(4) Statement that the third party 

conformity assessment body 

understands that it must reapply for 

acceptance of the accreditation scope for 

which it is requesting discontinuance; 

and 

(5) Verification that the person 

requesting the discontinuance has the 

authority to make such a request on 

behalf of the third party conformity 

assessment body. 

(b) The CPSC may verify the 

information submitted in a notice of 

voluntary discontinuance. 

(c) Upon receipt of a notice from a 

third party conformity assessment body 

that it wishes to discontinue voluntarily 

as a CPSC-accepted third party 

conformity assessment body, or after 

verifying the information in a notice, the 

CPSC will update its Web site to 

indicate that the CPSC no longer accepts 

the accreditation of the third party 

conformity assessment body for the 

scope indicated, as of the date provided 

in the notice. 

(d) Notwithstanding a third party 

conformity assessment body’s voluntary 

discontinuance as a CPSC-accepted 

third party conformity assessment body, 

the CPSC may begin or continue an 

investigation related to an adverse 

action under this part, or other legal 

action. 

5. Amend § 1112.35, as added 

elsewhere in this issue of the Federal 

Register and effective July 23, 2012, by 

adding paragraph (b) to read as follows: 

§ 1112.35 When must an audit be 

conducted? 

* * * * * 

(b) For the examination portion of the 

audit, which is conducted by the CPSC: 

(1) Each third party conformity 

assessment body must submit a CPSC 

Form 223 for audit purposes no less 

than every two years. When a CPSC 

Form 223 is submitted for audit 

purposes, the third party conformity 

assessment body must submit any 

accompanying documentation that 

would be required if it were a new 

application. 

(2) Under § 1112.13(a)(1), a third party 

conformity assessment body must 

submit a new CPSC Form 223 whenever 

the information supplied on the form 

changes. In the event that the third party 

conformity assessment body submits a 

new CPSC Form 223 to provide updated 

information, the third party conformity 

assessment body may elect to have the 

new CPSC Form 223 satisfy the 

requirement of paragraph (b)(1) of this 

section. If the third party conformity 

assessment body intends to have the 

new CPSC Form 223 treated as its 

submission for audit purposes, the third 

party conformity assessment body must 

make that intention clear upon 

submission, and it must submit any 

accompanying documentation that 

would be required if it were a new 

application. 

(3) At least 30 days prior to the date 

by which a third party conformity 

assessment body must submit a CPSC 

Form 223 for audit purposes, the CPSC 

will notify the body in writing, which 

may be electronic, of the impending 

audit deadline. A third party conformity 

assessment body may request an 

extension of the deadline for the 

examination portion of the audit, but it 

must indicate how much additional 

time is requested and explain why such 

an extension is warranted. The CPSC 

will notify the third party conformity 

assessment body whether its request for 

an extension has been granted. 

6. Amend part 1112, as added 

elsewhere in this issue of the Federal 

Register and effective July 23, 2012, by 

adding subpart D to read as follows: 

Subpart D—Adverse Actions: Types, 

Grounds, Allegations, Procedural 

Requirements, and Publication 

Sec. 

1112.41 What are the possible adverse 

actions the CPSC may take against a 

third party conformity assessment body? 

1112.43 What are the grounds for denial of 

an application? 

1112.45 What are the grounds for 

suspension of CPSC acceptance? 

1112.47 What are the grounds for 

withdrawal of CPSC acceptance? 

1112.49 How may a person submit 

information alleging grounds for adverse 

action, and what information should be 

submitted? 

1112.51 What are the procedures relevant to 

adverse actions? 

1112.53 Can the CPSC immediately 

withdraw its acceptance of the 

accreditation of a third party conformity 

assessment body? 

1112.55 Will the CPSC publish adverse 

actions? 

Subpart D—Adverse Actions: Types, 

Grounds, Allegations, Procedural 

Requirements, and Publication 

§ 1112.41 What are the possible adverse 

actions the CPSC may take against a third 

party conformity assessment body? 

(a) Potential adverse actions against a 

third party conformity assessment body 

include: 

(1) Denial of Acceptance of 

Accreditation; 

(2) Suspension of Acceptance of 

Accreditation; or 

(3) Withdrawal of Acceptance of 

Accreditation. 

(b) Withdrawal of acceptance of 

accreditation can be on a temporary or 

permanent basis, and the CPSC may 

immediately withdraw its acceptance in 


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accordance with § 1112.53 of this 

subpart. 

§ 1112.43 What are the grounds for denial 

of an application? 

(a) The CPSC may deny an 

application for any of the following 

reasons: 

(1) Failure to complete all 

information, and/or attestations, and/or 

failure to provide accompanying 

documentation, required in connection 

with an application within 30 days after 

notice of a deficiency by the CPSC; 

(2) Submission of false or misleading 

information concerning a material 

fact(s) on an application, any materials 

accompanying an application, or on any 

other information provided to the CPSC 

related to a third party conformity 

assessment body’s ability to become or 

to remain a CPSC-accepted third party 

conformity assessment body; or 

(3) Failure to satisfy necessary 

requirements described in § 1112.13, 

such as ISO/IEC 17025:2005 

accreditation by a ILAC–MRA signatory 

accreditation body for the CPSC scope 

for which acceptance of accreditation is 

being sought. 

(b) The CPSC’s denial of an 

application will follow the process 

described in § 1112.51 of this subpart. 

§ 1112.45 What are the grounds for 

suspension of CPSC acceptance? 

(a) The CPSC may suspend its 

acceptance of a third party conformity 

assessment body’s accreditation for any 

portion of its scope when the third party 

conformity assessment body fails to 

cooperate with an investigation under 

section 14 of the CPSA. A third party 

conformity assessment body ‘‘fails to 

cooperate’’ when it does not respond to 

CPSC inquiries or requests, or it 

responds in a manner that is 

unresponsive, evasive, deceptive, or 

substantially incomplete, or when it 

fails to cooperate with an investigatory 

inspection under § 1112.27. 

(b) Suspension lasts until the third 

party conformity assessment body 

complies, to the satisfaction of the 

CPSC, with required actions, as outlined 

in the notice described in § 1112.51(b), 

or until the CPSC withdraws its 

acceptance of the third party conformity 

assessment body. 

(c) If the CPSC determines that the 

third party conformity assessment body 

is cooperating sufficiently with the 

CPSC’s investigation, the CPSC will lift 

the suspension. The suspension will lift 

as of the date of the CPSC’s written 

notification to the third party 

conformity assessment body that the 

CPSC is lifting the suspension. The 

written notification may be by 

electronic mail. 

§ 1112.47 What are the grounds for 

withdrawal of CPSC acceptance? 

(a) A manufacturer, private labeler, 

governmental entity, or other interested 

party has exerted undue influence on 

such third party conformity assessment 

body or otherwise interfered with or 

compromised the integrity of the testing 

process. 

(b) The third party conformity 

assessment body failed to comply with 

an applicable protocol, standard, or 

requirement under subpart C of this 

part. 

(c) The third party conformity 

assessment body failed to comply with 

any provision in subpart B of this part. 

§ 1112.49 How may a person submit 

information alleging grounds for adverse 

action, and what information should be 

submitted? 

(a) Initiating Information. Any person 

may submit information to the 

Commission, such as by writing to the 

U.S. Consumer Product Safety 

Commission, 4330 East West Highway, 

Bethesda, MD 20814, or by sending 

electronic mail to: labaccred@cpsc.gov. 

The submission must allege that one or 

more of the grounds for adverse action 

set forth in this part exists. Any request 

for confidentiality must be indicated 

clearly in the submission. The 

submission should include: 

(1) Contact information, including a 

name and/or a method by which the 

CPSC may contact the person providing 

the information; 

(2) Identification of the third party 

conformity assessment body against 

whom the allegation is being made, 

identification of any officials or 

employees of the third party conformity 

assessment body relevant to the 

allegation, and contact information for 

such individuals. 

(3) Identification of any 

manufacturers, distributors, importers, 

private labelers, and/or governmental 

entities relevant to the allegation. The 

submission also should identify any 

officials or employees of the 

manufacturers, distributors, importers, 

private labelers, or governmental 

entities relevant to the allegation, and 

contact information for such 

individuals. 

(4) Description of acts and/or 

omissions to support each asserted 

ground for adverse action. Generally, 

the submission should describe, in 

detail, the basis for the allegation that 

grounds for adverse action against a 

third party conformity assessment body 

exists. In addition to a description of the 

acts and omissions and their 

significance, a description may include: 

Dates, times, persons, companies, 

governmental entities, locations, 

products, tests, test results, equipment, 

supplies, frequency of occurrence, and 

negative outcomes. When possible, the 

submission should attach documents, 

records, photographs, correspondence, 

notes, electronic mails, or any other 

information that supports the basis for 

the allegations; 

(5) Description of the impact of the 

acts and/or omissions, where known. 

(b) Review of Initiating Information. 

Upon receiving the information, the 

CPSC will review the information to 

determine if it is sufficient to warrant an 

investigation. The CPSC may deem the 

information insufficient to warrant an 

investigation if the information fails to 

address adequately the categories of 

information outlined in paragraph (a) of 

this section above. 

§ 1112.51 What are the procedures 

relevant to adverse actions? 

(a) Investigation. (1) Investigations 

under this part are investigations into 

grounds for an adverse action against a 

third party conformity assessment body. 

(2) The Commission will use its 

Procedures for Investigations, 

Inspections, and Inquiries, 16 CFR part 

1118, subpart A, to investigate under 

this part. 

(3) An investigation under this part 

may include any act the CPSC takes to 

verify the accuracy, veracity, and/or 

completeness of information received in 

connection with an application for 

acceptance of accreditation, a 

submission alleging grounds for an 

adverse action, or any other information 

received by the CPSC that relates to a 

third party conformity assessment 

body’s ability to become or remain a 

CPSC-accepted third party conformity 

assessment body. 

(4) The CPSC will begin an 

investigation under this part by 

providing written notice, which may be 

electronic, to the third party conformity 

assessment body. The notice will inform 

the third party conformity assessment 

body that the CPSC has received 

information sufficient to warrant an 

investigation, and it will describe the 

information received by the CPSC and 

the CPSC’s investigative process. The 

notice also will inform the third party 

conformity assessment body that failure 

to cooperate with a CPSC investigation 

is grounds for suspension under 

§ 1112.45 of this subpart. 

(5) The notice sent by the CPSC under 

§ 1112.35(b)(3) informing the third party 

conformity assessment body that it must 

submit a CPSC Form 223 for audit 

purposes, which may be electronic, 

constitutes notice of investigation for 

purposes of this section. The 


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examination portion of an audit under 

§ 1112.33(c) constitutes an investigation 

for purposes of this section. 

(b) Initial notice. If, after 

investigation, the CPSC determines that 

grounds for adverse action exist and 

proposes to take an adverse action 

against a third party conformity 

assessment body, the CPSC will notify 

the third party conformity assessment 

body, in writing, which may be 

electronic, about the proposed adverse 

action. If the proposed adverse action is 

suspension or withdrawal, the notice 

formally begins a proceeding to suspend 

or withdraw, as described in section 

14(e) of the CPSA. The notice will 

contain: 

(1) The proposed adverse action; 

(2) Specific grounds on which the 

proposed adverse action is based; 

(3) Findings of fact to support the 

proposed adverse action; 

(4) When appropriate, specific actions 

a third party conformity assessment 

body must take to avoid an adverse 

action; 

(5) When the proposed adverse action 

is withdrawal, consideration of the 

criteria set forth in paragraph (d)(1) of 

this section; 

(6) The time period by which a third 

party conformity assessment body has to 

respond to the notice. In general, the 

notice will inform the third party 

conformity assessment body that it has 

30 calendar days to respond. A third 

party conformity assessment body may 

request an extension of the response 

time, but they must explain why such 

an extension is warranted and the 

amount of additional time needed for a 

response; and 

(7) Except under § 1112.53, a CPSCaccepted third party conformity 

assessment body may continue to 

conduct tests for purposes of section 14 

of the CPSA until a Final Notice of 

adverse action is issued. 

(c) Third party conformity assessment 

body response to initial notice. A third 

party conformity assessment body’s 

response must be submitted in writing, 

in English, and may be in the form of 

electronic mail. The response may 

include, but is not limited to, an 

explanation or refutation of material 

facts upon which the Commission’s 

proposed action is based, supported by 

documents or sworn affidavit; results of 

any internal review of the matter and 

action(s) taken as a result; or a detailed 

plan and schedule for an internal 

review. The written response must state 

the third party conformity assessment 

body’s reasons why the ground(s) for 

adverse action does not exist, or for why 

the CPSC should not pursue the 

proposed adverse action, or any portion 

of the proposed adverse action. If a third 

party conformity assessment body 

responds to the notice in a timely 

manner, the CPSC will review the 

response, and, if necessary, investigate 

further to explore or resolve issues 

bearing on whether grounds exist for 

adverse action and the nature of the 

proposed adverse action. If a third party 

conformity assessment body does not 

respond to the notice in a timely 

manner, the CPSC may proceed without 

further delay to a Final Notice, as 

described in paragraph (e) of this 

section. 

(d) Proceeding. (1) In any proceeding 

to withdraw the CPSC’s acceptance of a 

third party conformity assessment 

body’s accreditation, the CPSC will 

consider the gravity of the third party 

conformity assessment body’s action or 

failure to act, including: 

(i) Whether the action or failure to act 

resulted in injury, death, or the risk of 

injury or death; 

(ii) Whether the action or failure to act 

constitutes an isolated incident or 

represents a pattern or practice; and 

(iii) Whether and when the third party 

conformity assessment body initiated 

remedial action. 

(2) In all cases, the CPSC will review 

and take under advisement the response 

provided by the third party conformity 

assessment body. Except for cases under 

paragraph (d)(3) of this section, the 

CPSC will determine what action is 

appropriate under the circumstances. 

(3) If, after reviewing and taking 

under advisement the response 

provided by a CPSC-accepted firewalled 

third party conformity assessment body, 

the CPSC staff concludes that 

suspension or withdrawal of CPSC 

acceptance of accreditation is 

appropriate, staff will transmit their 

recommendation to the Commission for 

consideration. Any suspension or 

withdrawal of CPSC acceptance of 

accreditation of a firewalled third party 

conformity assessment body (including 

immediate and temporary withdrawal 

under § 1112.53) will be by order of the 

Commission. 

(4) The CPSC may withdraw its 

acceptance of the accreditation of a 

third party conformity assessment body 

on a permanent or temporary basis. 

(5) If the CPSC withdraws its 

acceptance of the accreditation of a 

third party conformity assessment body, 

the CPSC may establish conditions for 

the reacceptance of the accreditation of 

the third party conformity assessment 

body, under section 14(e)(2)(B)(ii) of the 

CPSA. Any such conditions would be 

related to the reason(s) for the 

withdrawal. 

(e) Final notice. If, after reviewing a 

third party conformity assessment 

body’s response to a notice and 

conducting additional investigation, 

where necessary, the CPSC determines 

that grounds for adverse action exist, it 

will send a Final Notice to the third 

party conformity assessment body, in 

writing, which may be electronic. The 

Final Notice will state: 

(1) The adverse action that the CPSC 

is taking; 

(2) Specific grounds on which the 

adverse action is based; 

(3) Findings of fact that support the 

adverse action; 

(4) When the adverse action is 

withdrawal, consideration of the criteria 

as set forth in paragraph (d)(1) of this 

section; 

(5) When the adverse action is 

withdrawal, whether the withdrawal is 

temporary or permanent, and if 

temporary, the duration of the 

withdrawal; 

(6) The third party conformity 

assessment body’s accreditation is not 

accepted by the Commission as of the 

date of the Final Notice of denial, 

suspension, or withdrawal, for specified 

portion(s) of its CPSC scope. The CPSC 

Web site will be updated to reflect 

adverse actions to any previously CPSCaccepted third party conformity 

assessment bodies; and 

(7) Whether the third party 

conformity assessment body may submit 

a new application. 

(f) Possible actions after final notice. 

Upon receipt of a Final Notice, a third 

party conformity assessment body, as 

applicable, may: 

(1) If the Final Notice indicates such, 

the third party conformity assessment 

body may submit a new application; or 

(2) File an Administrative Appeal. 

(g) Administrative appeal. (1) Except 

for paragraph (g)(2) of this section, the 

third party conformity assessment body 

may file an Administrative Appeal with 

the Office of the Executive Director. 

(i) The Administrative Appeal must 

be sent, by mail, within 30 calendar 

days of the date on the Final Notice to: 

The Office of the Executive Director, 

Room 812, U.S. Consumer Product 

Safety Commission, 4330 East West 

Highway, Bethesda, MD 20814, or by 

electronic mail to: cpsc-os@cpsc.gov. 

(ii) All appeals must be in writing, in 

English. 

(iii) All appeals must explain the 

nature and scope of the issues appealed 

from in the Final Decision, and must 

describe in detail the reasons why the 

third party conformity assessment body 

believes that no ground(s) for adverse 

action exist. 


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(iv) If an Administrative Appeal is 

timely filed, the Executive Director will 

issue a Final Decision within 60 

calendar days of receipt. If the Executive 

Director’s Final Decision requires more 

than 60 calendar days, he or she will 

notify the third party conformity 

assessment body that more time is 

required, state the reason(s) why more 

time is required, and, if feasible, include 

an estimated date for a Final Decision to 

issue. 

(2) In the case that the Commission 

has suspended or withdrawn its 

acceptance of the accreditation of a 

firewalled third party conformity 

assessment body, the firewalled third 

party conformity assessment body may 

file an Administrative Appeal with the 

Commission. 

(i) The Administrative Appeal must 

be sent, by mail, within 30 calendar 

days of the date on the Final Notice to: 

The Office of the Secretary, Room 820, 

U.S. Consumer Product Safety 

Commission, 4330 East West Highway, 

Bethesda, MD 20814, or by electronic 

mail to: cpsc-os@cpsc.gov. 

(ii) All appeals must be in writing, in 

English. 

(iii) All appeals must explain the 

nature of the issues appealed from in 

the Final Decision, and must describe in 

detail the reasons why the third party 

conformity assessment body believes 

that no ground(s) for adverse action 

exist. 

§ 1112.53 Can the CPSC immediately 

withdraw its acceptance of the accreditation 

of a third party conformity assessment 

body? 

(a) When it is in the public interest to 

protect health and safety, and 

notwithstanding any other provision of 

this part, the CPSC may withdraw 

immediately and temporarily its 

acceptance of a third party conformity 

assessment body’s accreditation for any 

portion of its CPSC scope while the 

CPSC pursues an investigation and 

potential adverse action under § 1112.51 

of this subpart. 

(1) For purposes of this part, ‘‘in the 

public interest to protect health and 

safety’’ means that the CPSC has 

credible evidence that: 

(i) The integrity of test(s) being 

conducted under a scope for which the 

CPSC has accepted the third party 

conformity assessment body’s 

accreditation, have been affected by 

undue influence or otherwise interfered 

with or compromised; and 

(ii) The scope for which the CPSC has 

accepted the third party conformity 

assessment body’s accreditation involve 

a product(s) which, if noncompliant 

with CPSC rules, bans, standards, and/ 

or regulations, constitutes an 

imminently hazardous consumer 

product under section 12 of the CPSA. 

(2) When presented with an allegation 

that, if credible, would result in 

immediate and temporary withdrawal of 

CPSC acceptance of a third party 

conformity assessment body’s 

accreditation, the investigation and 

adverse action procedures described in 

§ 1112.51 apply, except that instead of 

the timeframes described in § 1112.51, 

the following timeframes will apply 

when the CPSC pursues immediate and 

temporary withdrawal: 

(i) The Initial Notice will generally 

inform the third party conformity 

assessment body that it has 7 calendar 

days to respond. 

(ii) An administrative appeal of a 

Final Notice of immediate and 

temporary withdrawal will be timely if 

filed within 7 calendar days of the date 

of the Final Notice. 

(b) If the third party conformity 

assessment body is already the subject 

of an investigation or adverse action 

process under § 1112.51 of this subpart, 

the immediate and temporary 

withdrawal will remain in effect until: 

The agency communicates in writing 

that the immediate and temporary 

withdrawal has been lifted; the 

investigation concludes and the agency 

does not propose an adverse action; or 

the adverse action process concludes 

with denial, suspension, or withdrawal. 

(c) If the third party conformity 

assessment body is not already the 

subject of an investigation or adverse 

action process under § 1112.51 of this 

subpart, an investigation under 

§ 1112.51(a) will be launched based on 

the same information that justified the 

immediate and temporary withdrawal. 

§ 1112.55 Will the CPSC publish adverse 

actions? 

Immediately following a final adverse 

action, the CPSC may publish the fact of 

a final adverse action, the text of a final 

adverse action, or a summary of the 

substance of a final adverse action. After 

issuance of a final adverse action, the 

CPSC will amend its Web site listing of 

CPSC-accepted third party conformity 

assessment bodies to reflect the nature 

and scope of such adverse action. 

PART 1118—INVESTIGATIONS, 

INSPECTIONS, AND INQUIRIES 

UNDER THE CONSUMER PRODUCT 

SAFETY ACT 

7. The authority citation for part 1118 

is revised to read as follows: 

Authority: 15 U.S.C. 2063; 15 U.S.C. 2065; 

15 U.S.C. 2068; 15 U.S.C. 2076; sec. 3, Pub. 

L. 110–314, 122 Stat. 3016. 

8. Amend § 1118.2 by revising 

paragraph (a) to read as follows: 

§ 1118.2 Conduct and scope of 

inspections. 

(a) After an inspection is initiated as 

set forth in § 1118.1, an officer or 

employee duly designated by the 

Commission shall issue the notice of 

inspection (hereinafter referred to as 

‘‘notice’’). Upon presenting the notice, 

along with appropriate credentials, to 

the person or agent in charge of the firm 

to be inspected, the Commission officer 

or employee is authorized for the 

purposes set forth in § 1118.1(a): 

(1) To enter, at reasonable times, any 

factory, warehouse, firewalled third 

party conformity assessment body, or 

establishment in which products are 

manufactured, tested, or held, in 

connection with distribution in 

commerce, or any conveyance being 

used to transport products in 

connection with distribution in 

commerce; and 

(2) To inspect, at reasonable times and 

in a reasonable manner, any conveyance 

or those areas of the factory, warehouse, 

firewalled third party conformity 

assessment body, or establishment 

where products are manufactured, 

tested, held, or transported and that may 

relate to the safety of those products; 

and 

(3) To have access to and to copy all 

relevant records, books, documents, 

papers, packaging, or labeling which: 

(i) Is required by the Commission to 

be established, made or maintained, or 

(ii) Show or relate to the production, 

inventory, testing, distribution, sale, 

transportation, importation, or receipt of 

any product, or that are otherwise 

relevant to determining whether any 

person or firm has acted or is acting in 

compliance with the Act and 

regulations, rules, and orders 

promulgated under the Act, and 

(4) To obtain: 

(i) Information, both oral and written, 

concerning the production, inventory, 

testing, distribution, sale, 

transportation, importation, or receipt of 

any product, and the organization, 

business, conduct, practices, and 

management of any person or firm being 

inspected and its relation to any other 

person or firm; 

(ii) Samples of items, materials, 

substances, products, containers, 

packages and packaging, and labels and 

labeling, or any component at 

manufacturer’s, distributor’s, third party 

conformity assessment body’s, or 

retailer’s cost, unless voluntarily 

provided; and 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Proposed Rules 31141 

(iii) Information, both oral and 

written, concerning any matter referred 

to in the Act and these rules. 

* * * * * 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2012–10923 Filed 5–23–12; 8:45 am] 

BILLING CODE 6355–01–P 


srobinson on DSK4SPTVN1PROD with PROPOSALS2