31074 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1112 

[CPSC Docket No. CPSC–2009–0061] 

Audit Requirements for Third Party 

Conformity Assessment Bodies 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (‘‘CPSC,’’ ‘‘Commission,’’ 

or ‘‘we’’) is issuing a final rule 

establishing requirements for the 

periodic audit of third party conformity 

assessment bodies as a condition of 

their continuing accreditation. 

The final rule implements a section of 

the Consumer Product Safety Act 

(‘‘CPSA’’), as amended by the Consumer 

Product Safety Improvement Act of 

2008 (‘‘CPSIA’’). 

DATES: This rule is effective on July 23, 

2012. 

FOR FURTHER INFORMATION CONTACT: 

Randy Butturini, U.S. Consumer 

Product Safety Commission, 4330 East 

West Highway, Bethesda, MD 20814; 

301–504–7562; email: 

RButturini@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

In the Federal Register of August 13, 

2009 (74 FR 40784), we published a 

proposed rule that would establish 

requirements for the periodic audit of 

third party conformity assessment 

bodies as a condition of their continuing 

accreditation. The proposed rule would 

implement section 14(d)(1) of the CPSA, 

as amended by section 102(b) of the 

CPSIA. (On August 12, 2011, the 

President signed into law Public Law 

112–28, which amended both the CPSA 

and the CPSIA. Section 10(a) of Public 

Law 112–28 redesignates what was 

identified as section 14(d) of the CPSA 

in the preamble of the proposed rule as 

section 14(i) of the CPSA; consequently, 

except where we are citing language 

from the proposed rule, the remainder 

of this document will refer to section 

14(i) of the CPSA.) 

Section 14(a)(1) of the CPSA (15 

U.S.C. 2063(a)(1)) requires that the 

manufacturer (including the importer) 

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 

certificate, which 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 

specifies each rule, ban, standard, or 

regulation applicable to the product. 

This requirement applies to any such 

product manufactured on or after 

November 12, 2008. 

Section 14(a)(2) of the CPSA 

establishes a third party testing 

requirement for children’s products that 

are subject to a children’s product safety 

rule. In general, section 14(a)(2) of the 

CPSA states, in part, that every 

manufacturer or private labeler (if the 

children’s product bears a private label) 

of such products 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 to be tested 

for compliance with such children’s 

product safety rule. 

In the Federal Register of May 20, 

2010 (75 FR 28336), we published a 

proposed rule that would establish the 

requirements for a reasonable testing 

program and for compliance and 

continued testing of children’s products. 

In the Federal Register of November 8, 

2011 (76 FR 69482), we published a 

final rule with respect to compliance 

and continued testing of children’s 

products. 

Section 14(a)(3) of the CPSA 

establishes various timelines for 

accreditation 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. We have published several 

notices of requirements in the Federal 

Register (see, e.g., 76 FR 49286 (August 

10, 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 46598 (August 3, 

2011) (‘‘Third Party Testing for Certain 

Children’s Products; Toys: 

Requirements for Accreditation of Third 

Party Conformity Assessment Bodies’’)). 

Section 14(a)(3)(C) of the CPSA states 

that accreditation of third party 

conformity assessment bodies may be 

conducted by the Commission or by an 

independent accreditation organization 

designated by the Commission. 

Section 14(i)(1) of the CPSA requires 

the Commission to establish 

‘‘requirements for the periodic audit of 

third party conformity assessment 

bodies as a condition for the continuing 

accreditation of such conformity 

assessment bodies’’ under section 

14(a)(3)(C) of the CPSA. This final rule 

implements section 14(i)(1) of the 

CPSA. 

II. Comments on the Proposed Rule, the 

CPSC’s Responses, and a Description of 

the Final Rule 

The proposed rule would create a new 

part 1112, titled, ‘‘Audit Requirements 

for Third Party Conformity Assessment 

Bodies,’’ in Title 16 of the Code of 

Federal Regulations. Six commenters 

responded to the proposal. 

We describe and respond to the 

comments in this section of this 

document and also describe the final 

rule. A summary of each of the 

commenter’s topics is presented, and 

each topic is followed by staff’s 

response. For ease of reading, each topic 

will be prefaced with 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 Specific Provisions 

Most commenters addressed specific 

sections in the proposed rule, or 

referenced issues associated with a 

particular term in a proposed section, 

but not directly relevant to the proposed 

section itself. We address those 

comments in this section. However, on 

our own initiative, we have renumbered 

the sections and renamed the part in 

which the sections will be placed. For 

example, proposed § 1112.1, titled, 

‘‘Purpose,’’ is now renumbered as 

§ 1112.20. As another example, the 

proposed rule would have created a part 

1112, titled, ‘‘Audit Requirements for 

Third Party Conformity Assessment 

Bodies’’; however, the final rule divides 

the audit requirements into two 

subparts and renames part 1112, 

‘‘Requirements Pertaining to Third Party 

Conformity Assessment Bodies.’’ We 

have taken this action because, 

elsewhere in this issue of the Federal 

Register, we have published a proposed 

rule to establish other requirements 

pertaining to third party conformity 

assessment bodies (such as the 

requirements for accreditation and 

provisions for the withdrawal and 

suspension of third party conformity 

assessment bodies) and wish to place all 

requirements for third party conformity 

assessment bodies in a single location. 

This will make it easier for interested 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 31075 

parties to locate the regulations 

pertaining to third party conformity 

assessment bodies. 

1. § 1112.30—Purpose 

Proposed § 1112.1 (now renumbered 

as § 1112.30 in the final rule) would 

describe the purpose of the audit rule. 

In brief, proposed § 1112.1 would state 

that part 1112 ‘‘establishes the audit 

requirements for third party conformity 

assessment bodies pursuant to section 

14(d)(1) of the Consumer Product Safety 

Act (CPSA) (15 U.S.C. 2063(d)(1)).’’ 

Under section 14(i)(1) of the CPSA, 

compliance with the requirements in 

part 1112 would be a condition of 

continuing the accreditation of such 

third party conformity assessment 

bodies. 

(Comment 1)—One commenter noted 

that the proposal referred to certifying 

organizations under the Labeling of 

Hazardous Art Materials Act (LHAMA). 

The commenter stated that art and craft 

companies cannot afford both LHAMA 

and what the commenter called 

‘‘redundant’’ testing under the CPSIA. 

The commenter said that retailers that 

do not recognize the Art and Creative 

Materials Institute (ACMI) as a third 

party conformity assessment body are 

demanding additional tests. The 

commenter said the CPSC should 

consider the acceptance of current 

certification programs, such as ACMI’s, 

to be in full compliance with the CPSIA. 

(Response 1)—Although issues related 

to product testing are outside the scope 

of the audit rule, the commenter may 

have misinterpreted the statute and the 

proposed rule’s reference to certifying 

organizations under LHAMA. Section 

14(f)(2)(C) of the CPSA states that 

certifying organizations, as defined in 

appendix A to 16 CFR 500.14(b)(8), are 

third party conformity assessment 

bodies with respect to certifying art 

materials and art products to Federal 

Hazardous Substances Act (FHSA) 

requirements. Current certification 

programs, such as ACMI’s, are for 

certifying to LHAMA rules. Section 14 

of the CPSA, however, also requires 

children’s products to be tested for 

compliance to children’s product safety 

rules; and it defines ‘‘children’s product 

safety rules’’ as ‘‘a consumer product 

safety rule under [the CPSA] or similar 

rule, regulation, standard, or ban under 

any other Act enforced by the 

Commission, including a rule declaring 

a consumer product to be a banned 

hazardous product or substance.’’ Thus, 

because the definition of ‘‘children’s 

product safety rule’’ is broader than 

certification of art materials and art 

products to FHSA requirements, testing 

under section 14 of the CPSA is not 

‘‘redundant’’ to LHAMA certification. 

Therefore, the final rule retains the 

text of the ‘‘Purpose’’ section, although 

we have replaced ‘‘part,’’ with 

‘‘subpart,’’ to reflect that the audit 

requirements are now subpart C of part 

1112. Additionally, on our own 

initiative, we have: 

• Changed the title from ‘‘Purpose,’’ 

to ‘‘What Is the Purpose of this 

Subpart?’’ to be consistent with the style 

used for other headings in the final rule; 

• Revised the second sentence stating 

that ‘‘Compliance with these 

requirements is condition for the 

continuing accreditation * * *’’ to 

‘‘Compliance with these requirements is 

a condition of the continuing 

accreditation * * *’’; and 

• Revised the third sentence by 

inserting a comma between ‘‘Labeling of 

Hazardous Art Materials Act’’ and 

‘‘even.’’ 

These changes are not substantive, 

and the latter two changes were made 

for grammatical purposes. 

2. Subpart A—Purpose and Definitions 

Proposed § 1112.3 would define 

various terms used in part 1112. The 

final rule now places all definitions in 

§ 1112.3 in subpart A, ‘‘Purpose and 

Definitions.’’ 

a. Accreditation 

Proposed § 1112.3(a) would define 

‘‘accreditation’’ as: 

A procedure by which an 

authoritative body gives formal 

recognition that a third party conformity 

assessment body is competent to 

perform specific tasks. Accreditation 

recognizes a third party conformity 

assessment body’s technical competence 

and is usually specific for tests of the 

systems, products, components, or 

materials for which the third party 

conformity assessment body claims 

proficiency. 

The preamble to the proposed rule 

explained that the definition was based 

on a description used by the 

International Organization for 

Standardization (ISO) in relation to ISO 

Standard ISO/IEC 17025:2005, ‘‘General 

Requirements for the Competence of 

Testing and Calibration Laboratories,’’ 

except that it uses the term ‘‘third party 

conformity assessment body,’’ instead of 

‘‘lab,’’ and refers to ‘‘technical 

competence,’’ instead of ‘‘technical 

capability’’ (see 74 FR at 40785). We 

explained that the term ‘‘third party 

conformity assessment body’’ is used in 

section 14(a)(3)(C) of the CPSA, and that 

we were aware that ISO/IEC 

17025:2005, by reference, incorporates 

the definitions set forth in ISO/IEC 

17000:2004, ‘‘Conformity Assessment— 

Vocabulary and General Principles,’’ but 

we decided against adopting the 

definition of ‘‘accreditation’’ in ISO/IEC 

17000 because it incorporates several 

other definitions by implied reference. 

(Comment 2)—One commenter would 

revise the first sentence of the definition 

to define ‘‘accreditation’’ as: ‘‘A 

procedure by which an authoritative 

body gives formal recognition that a 

third party conformity assessment body 

meets competence requirements to 

perform specific tasks.’’ The commenter 

explained that accreditation is ‘‘not a 

subjective assessment of competence 

based on whatever the individual 

assessors think is important, but rather 

is a requirements-based activity.’’ 

(Response 2)—We agree with the 

commenter, and we have revised the 

definition accordingly. 

Additionally, on our own initiative, 

we have revised the numbering in 

§ 1112.3, generally, to eliminate the 

paragraph designations before each 

defined term. We removed the 

paragraph designations to be more 

consistent with accepted formats for 

regulations. 

(Comment 3)—One commenter 

suggested revising the definition of 

‘‘accreditation’’ to ‘‘meet the 

international requirement,’’ but they did 

not explain what is meant by ‘‘the 

international requirement.’’ 

(Response 3)—For purposes of this 

response, we assume that the 

commenter’s reference to ‘‘international 

requirement’’ means the definitions 

used in ISO/IEC 17000:2004, 

‘‘Conformity Assessment—Vocabulary 

and General Principles.’’ Section 5.5 of 

ISO/IEC 17000: 2004 defines 

‘‘accreditation’’ as ‘‘third party 

attestation (5.2) related to a conformity 

assessment body (2.5) conveying a 

formal demonstration of its competence 

to carry out specific conformity 

assessment tasks.’’ As we explained in 

the preamble to the proposed rule, ISO/ 

IEC’s definition of ‘‘accreditation’’ 

incorporates several other definitions by 

implied reference; therefore, we chose 

to adopt a more detailed definition of 

the term, rather than adopt a definition 

from ISO/IEC 17000, whose terms 

would compel the reader to consult 

even more definitions before they could 

understand how the rule defines 

‘‘accreditation’’ (see 74 FR at 40785). 

Alternatively, because the commenter 

also discussed requiring reciprocity, it is 

possible that they meant to suggest that 

we amend the definition of 

‘‘accreditation’’ to include a reciprocity 

requirement. As discussed later in part 

II.B of this preamble in the response to 


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Comment 12, a reciprocity requirement 

is beyond the scope of this rule. 

Consequently, we decline to revise 

the definition as suggested by the 

commenter. 

(Comment 4)—Another commenter 

stated that ISO/IEC 17025:2005 and ISO 

17000:2004 have definitions that are the 

result of a consensus and are 

‘‘universally accepted and understood.’’ 

The commenter said that the proposal’s 

use of different definitions or 

modification of ISO definitions ‘‘will 

create unnecessary problems in the 

process of accreditation and audits and 

should be avoided.’’ 

(Response 4)—As the preamble to the 

proposed rule explained (see 74 FR at 

40785), in the definition of 

‘‘accreditation,’’ we chose to substitute 

the term ‘‘third party conformity 

assessment body’’ instead of ‘‘lab’’ to be 

consistent with the language in section 

14(a)(3)(C) of the CPSA. The preamble 

to the proposed rule explained other 

differences between the proposed 

definitions and ISO/IEC 17025:2005 and 

ISO 17000:2004; for example, we chose 

to define some terms to be consistent 

with notices of requirements issued by 

the Commission, while other definitions 

are almost identical to the 

corresponding ISO definition (id. at 

40785 through 40786). 

Furthermore, because the commenter 

did not identify how any proposed 

definition would cause ‘‘unnecessary 

problems,’’ we decline to revise the rule 

as suggested by the commenter. 

b. Accreditation Body 

Proposed § 1112.3(b) would define 

‘‘accreditation body’’ as ‘‘an entity that 

accredits or has accredited a third party 

conformity assessment body as meeting, 

at a minimum, the International 

Organization for Standardization (ISO) 

Standard ISO/IEC 17025:2005, ‘General 

Requirements for the Competence of 

Testing and Calibration Laboratories,’ ’’ 

and any test methods or consumer 

product safety requirements specified in 

the relevant notice of requirements 

issued by the Commission, and is a 

signatory to the International Laboratory 

Accreditation Cooperation–Mutual 

Recognition Arrangement. The preamble 

to the proposed rule explained that the 

proposed definition of ‘‘accreditation 

body’’ reflects the basic elements that 

the Commission has specified in its 

notices of requirements for the 

accreditation of third party conformity 

assessment bodies. The preamble also 

explained that the phrase ‘‘at a 

minimum’’ recognizes that some 

accreditation bodies, as part of the 

accreditation process, may demand that 

a third party conformity assessment 

body demonstrate its conformity with 

specific methods or programs, as well as 

demonstrate compliance with ISO/IEC 

17025:2005 and with any test methods 

identified in the relevant notices of 

requirements issued by the Commission. 

(Comment 5)—Several commenters 

addressed issues relating to ISO/IEC 

17025:2005 rather than the definition 

itself. 

One commenter said that ISO/IEC 

17025:2005 is a ‘‘good baseline,’’ but 

nevertheless, asserted that the CPSC 

should create a mechanism to supervise 

and control the acceptance of 

government-owned or governmentcontrolled conformity assessment 

bodies and firewalled conformity 

assessment bodies to help ensure their 

protection against undue influence. (A 

firewalled conformity assessment body 

is one that is owned, managed, or 

controlled by a manufacturer or private 

labeler of a children’s product to be 

tested by the conformity assessment 

body for certification purposes and that 

seeks accreditation under the additional 

statutory criteria for ‘‘firewalled’’ 

conformity assessment bodies.) 

(Response 5)—Although the 

commenter’s focus on issues of undue 

influence goes beyond the scope of the 

rule, we note that the statutory 

accreditation requirements pertaining to 

undue influence and governmentowned, government-controlled, and 

firewalled conformity assessment bodies 

exceed those of ISO/IEC 17025:2005. 

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

firewalled conformity assessment bodies 

to have procedures to ensure that test 

results are protected from undue 

influence by the manufacturer, private 

labeler, or other interested party. 

Conformity assessment bodies that 

apply for CPSC approval as firewalled 

laboratories must submit to the 

Commission copies of their training 

documents, showing how employees are 

trained to notify the Commission 

immediately and confidentially of any 

attempt by the manufacturer, private 

labeler, or other interested party to hide 

or exert undue influence over the third 

party conformity assessment body’s test 

results. 

For governmental laboratory 

applicants, CPSC staff engages the 

governmental entities relevant to 

requests for CPSC acceptance to obtain 

the necessary assurances of compliance 

with the statutory requirements for 

governmental conformity assessment 

bodies (laboratories). Section 14(f)(2)(B) 

of the CPSA requires that governmentalowned or controlled conformity 

assessment bodies may apply for CPSC 

recognition of their accreditation and be 

subject to the audit provisions, if, 

among other requirements: 

• The conformity assessment body’s 

testing results are not subject to undue 

influence by any other person, 

including another governmental entity; 

and 

• The conformity assessment body 

does not exercise undue influence over 

other governmental authorities 

controlling distribution of products 

based on outcomes of the conformity 

assessment body’s conformity 

assessments. 

Thus, the final rule retains the 

definition of ‘‘accreditation body’’ 

without change, except that, on our own 

initiative, we have inserted ‘‘/ 

International Electrotechnical 

Commission (IEC)’’ after ‘‘International 

Organization for Standardization (ISO)’’ 

to provide the full name corresponding 

to the abbreviation ‘‘IEC’’; and we added 

‘‘:2005’’ after ‘‘17025’’ to identify the 

particular edition of the standard. We 

address the process for initially 

accepting government and firewalled 

laboratories in the proposed rule on 

‘‘Requirements Pertaining to Third Party 

Conformity Assessment Bodies.’’ 

(Comment 6)—One commenter said 

that there are substantial differences 

among accreditation bodies. In some 

cases, the conformity assessment body 

and the accreditation body are both 

government-controlled. The commenter 

added that H.R. 2749, titled, the ‘‘Food 

Safety Enhancement Act of 2009,’’ has 

stricter requirements for firewalled 

conformity assessment bodies, 

including a restriction on such 

laboratories certifying their own 

products. The commenter suggested that 

the CPSC designate individual 

accreditation bodies based on specific 

criteria to prove their competency with 

CPSC requirements. 

(Response 6)—The Commission, 

through its notices of requirements, has 

required all third party conformity 

assessment bodies to be accredited by 

an accreditation body that is a signatory 

to the International Laboratory 

Accreditation Cooperation-Mutual 

Recognition Arrangement (ILAC–MRA) 

and further mandated that the scope of 

the accreditation include testing relative 

to the appropriate test method(s) or 

regulation(s) cited in the notice of 

requirements. All ILAC–MRA 

accreditation bodies must maintain 

conformity with the current version of 

ISO/IEC 17011 and related ILAC 

guidance documents and ensure that all 

accredited laboratories comply with 

ISO/IEC 17025:2005 and applicable 

ILAC policy and guidance documents. 

This ensures some degree of similarity 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 31077 

or uniformity among accreditation 

bodies, regardless of their geographical 

location, and it also ensures consistency 

among third party conformity 

assessment bodies accredited by such 

ILAC–MRA accreditation bodies. 

Requiring specific criteria of 

accreditation bodies is beyond the scope 

of the requirements for auditing 

conformity assessment bodies. 

As for the Food Safety Enhancement 

Act of 2009, it would restrict testing 

laboratories’ certification activities. 

However, under section 14 of the CPSA 

and CPSC regulations at 16 CFR part 

1110, third party conformity assessment 

bodies do not issue certifications; 

accordingly, the bill’s potential 

requirements are not directly relevant 

here. Additionally, nothing in section 

14 of the CPSA prohibits firewalled 

conformity assessment bodies from 

testing a manufacturer’s own products. 

c. Audit 

Proposed § 1112.3(c) would define 

‘‘audit’’ as ‘‘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.’’ The preamble to the proposed 

rule (74 FR at 40785) explained that this 

definition is almost identical to the 

definition of ‘‘audit’’ in ISO/IEC 17000. 

Proposed § 1112.3(c) also would explain 

that, for purposes of part 1112, an audit 

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 that 

the remainder of this preamble will refer 

to as a ‘‘reassessment’’); and (2) the 

resubmission of the ‘‘Consumer Product 

Conformity Assessment Body 

Acceptance Registration Form’’ (CPSC 

Form 223) by the third party conformity 

assessment body and the CPSC’s 

examination of the resubmitted CPSC 

Form 223 (that the remainder of this 

preamble will refer to as an 

‘‘examination’’ by the CPSC). 

We received no comments on the 

proposed definition. However, on our 

own initiative, we have revised the 

phrase, ‘‘is composed of two parts,’’ to 

read ‘‘consists of two parts.’’ This 

change is for grammatical purposes 

only. Additionally, as stated earlier in 

part II.A of this preamble in the 

response to Comment 2, we have 

removed the paragraph designation; 

thus, the definition of ‘‘audit’’ is now at 

§ 1112.3 of the final rule rather than at 

§ 1112.3(c) (as proposed). 

d. Commission 

Proposed § 1112.3(d) would define 

‘‘Commission’’ to mean the Consumer 

Product Safety Commission. 

We received no comments on this 

provision, and therefore, other than 

removing the paragraph designation 

(i.e., removing ‘‘(d)’’ before the 

definition of ‘‘Commission’’ appears), 

we have finalized the provision without 

change. 

e. Quality Manager 

Proposed § 1112.3(e) would define 

‘‘quality manager’’ as an individual 

‘‘(however named) who, irrespective of 

other duties and responsibilities, has 

defined responsibility and authority for 

ensuring that the management system 

related to quality is implemented and 

followed at all times and who has direct 

access to the highest level of 

management at which decisions are 

made on the conformity assessment 

body’s policy or resources.’’ The 

preamble to the proposed rule explained 

that this definition is patterned after the 

explanation of the quality manager’s 

role in ISO/IEC 17025:2005, section 

4.1.5 (74 FR at 40786). 

We received no comments on this 

provision, and therefore, other than 

removing the paragraph designation, we 

have finalized the provision without 

change. 

f. Use of Statutory Definitions 

Proposed § 1112.3(f) would explain 

that, unless otherwise stated, the 

definitions of section 3 of the CPSA, and 

additional definitions in the CPSIA, are 

applicable for purposes of part 1112 of 

this title. Thus, for example, the 

CPSIA’s definition of ‘‘third party 

conformity assessment body,’’ which 

includes independent conformity 

assessment bodies, government-owned 

or government-controlled conformity 

assessment bodies (subject to certain 

requirements in section 14(f)(2)(B) of the 

CPSA), and ‘‘firewalled’’ conformity 

assessment bodies (subject to certain 

requirements in section 14(f)(2)(D) of 

the CPSA), would apply to part 1112; 

and the term ‘‘third party conformity 

assessment body’’ in part 1112 would be 

understood to include all three types of 

conformity assessment bodies. 

(Comment 7)—One commenter stated 

that referring to firewalled and 

government-owned or governmentcontrolled conformity assessment 

bodies as ‘‘third party conformity 

assessment bodies’’ misuses a term with 

a specific definition. The commenter 

said that there are differences in how 

conformity assessment bodies operate 

and opined further that the CPSC 

‘‘needs to address those differences, not 

only in their accreditation requirements, 

but also in their audit requirements.’’ 

(Response 7)—Although the 

commenter did not identify a particular 

provision, we assume that the 

commenter was addressing part of the 

preamble to the proposed rule in which 

the Commission explained that under 

proposed § 1112.3(f), ‘‘unless otherwise 

stated, the definitions of section 3 of the 

CPSA and additional definitions in the 

CPSIA apply for purposes of part 1112 

of this title’’ (see 74 FR at 40786). The 

preamble to the proposed rule added: 

‘‘Thus, for example, the CPSIA’s 

definition of ‘third party conformity 

assessment body,’ which includes 

independent conformity assessment 

bodies, government-owned or 

government-controlled conformity 

assessment bodies (subject to certain 

requirements in section 14(f)(2)(B) of the 

CPSA), and ‘firewalled’ conformity 

assessment bodies (subject to certain 

requirements in section 14(f)(2)(D) of 

the CPSA), would apply to part 1112, 

and the term ‘third party conformity 

assessment body’ in part 1112 would be 

understood as including all three types 

of conformity assessment bodies’’ (id.). 

Thus, with respect to the definition of 

‘‘third party conformity assessment 

body,’’ the preamble to the proposed 

rule was referring to the section 14(f)(2) 

of the CPSA. Because the statute 

considers government-owned or 

government-controlled conformity 

assessment bodies and firewalled 

conformity assessment bodies to fall 

under ‘‘third party conformity 

assessment body’’ in section 14(f)(2) of 

the CPSA, we decline to revise the rule 

as suggested by the comment. 

As for establishing different 

accreditation requirements, sections 

14(f)(2)(B) and (f)(2)(D) of the CPSA 

already establish different requirements 

for government-owned or governmentcontrolled conformity assessment 

bodies and firewalled conformity 

assessment bodies. Furthermore, the 

Commission, through its notices of 

requirements for the accreditation of 

third party conformity assessment 

bodies, establishes accreditation 

requirements. Thus, the commenter’s 

request for different accreditation 

requirements is outside the scope of this 

rule. 

With respect to different audit 

requirements, the commenter did not 

suggest any changes to the rule that 

would apply to government-owned, 

government-controlled, or firewalled 

conformity assessment bodies. 

Consequently, we have no basis to 

establish different audit requirements 


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for different types of third party 

conformity assessment bodies. 

3. § 1112.31—Who is subject to these 

audit requirements? 

Proposed § 1112.5 (now renumbered 

as § 1112.31 in the final rule) would 

explain that the requirements in part 

1112 apply to third party conformity 

assessment bodies operating pursuant to 

section 14(a)(2) of the CPSA, and it 

would reiterate that third party 

conformity assessment bodies must 

comply with the audit requirements as 

a condition of the Commission’s 

acceptance of their accreditation. 

We received no comments on this 

provision, and other than to renumber 

it, we have finalized the provision 

without change. 

4. § 1112.33—What must an audit 

address or cover? Who conducts the 

audit? 

Proposed § 1112.3(c) would explain 

that, for purposes of part 1112, an audit 

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 (the ‘‘reassessment’’ 

portion of the audit); and (2) the 

resubmission of the ‘‘Consumer Product 

Conformity Assessment Body 

Acceptance Registration Form’’ (CPSC 

Form 223) by the third party conformity 

assessment body and the CPSC’s 

examination of the resubmitted CPSC 

Form 223. If the third party conformity 

assessment body is a ‘‘firewalled’’ 

conformity assessment body or a 

government-owned or governmentcontrolled 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. 

a. § 1112.33(a)—What does the 

reassessment portion of the audit cover? 

Under proposed § 1112.7(a) (now 

renumbered as § 1112.33(a) in the final 

rule), the reassessment portion of the 

audit may cover the management 

systems, specific tests, types of tests, 

calibrations, or types of calibrations that 

are the subject of the third party 

conformity assessment body’s 

accreditation. The proposal also stated 

that the reassessment portion must 

examine the third party conformity 

assessment body’s management systems 

to ensure that the third party conformity 

assessment body is free from any undue 

influence regarding its technical 

judgment. 

(Comment 8)—One commenter noted 

that the text might be interpreted to 

require that only the management 

system from ISO/IEC 17025:2005 be 

met. The commenter said that we 

should require applicants to fulfill all 

requirements in ISO/IEC 17025:2005 

rather than the management 

requirements. 

(Response 8)—We interpret the 

commenter as referring to the preamble 

to the proposed rule (74 FR at 40786), 

which states that ‘‘Under proposed 

§ 1112.7(a), the reassessment portion of 

the audit may cover the management 

systems, specific tests * * *.’’ and 

referencing proposed § 1112.7(a), which 

also uses the word ‘‘may.’’ 

During the reassessment portion of 

the audit, the accreditation body 

examines the competence of the entire 

operation of the conformity assessment 

body, including the competence of the 

personnel, the validity of the conformity 

assessment methodology, and the 

validity of the conformity assessment 

results. We agree with the commenter 

that the use of the word ‘‘may’’ in these 

sections could be misinterpreted as not 

requiring compliance by the conformity 

assessment body with all sections of 

ISO/IEC 17025:2005, and the proposed 

rule was not intended to suggest that the 

reassessment could be limited to 

management systems alone. To the 

contrary, the proposal’s mention of 

‘‘specific tests, types of tests, 

calibrations, or types of calibrations’’ 

was to show that a reassessment extends 

to technical requirements too. 

Consequently, we have revised 

§ 1112.33(a) to state that the 

reassessment portion of an audit of a 

conformity assessment body by an 

accreditation body covers management 

requirements and technical 

requirements. The remainder of 

§ 1123.33(a), pertaining to examination 

of the third party conformity assessment 

body’s management systems, is 

unchanged. 

(Comment 9)—Several commenters 

said that because products must be 

certified as being in compliance, the 

principles for impartiality and undue 

influence need to come from ISO/IEC 

Guide 65, General Requirements for 

Bodies Operating Product Certification 

Systems, which is a standard for 

certifying bodies. One commenter said 

that ISO/IEC Guide 65 is important 

especially for firewalled and 

government conformity assessment 

bodies. Additionally, the commenter 

said that the CPSC should require 

‘‘applicants’’ to submit evidence of 

fulfillment of ISO/IEC 17025:2005 

section 4.1.5.b. as part of their 

application to the CPSC, both initially 

and with ongoing audits. The 

commenter said that this information is 

needed in addition to current firewalled 

training and that applicants need to be 

able to notify the Commission about 

undue influence. Further, ISO/IEC 

Guide 65 has several requirements to 

protect impartiality and conflict of 

interest, the commenter noted. 

One commenter added that the 

Occupation Safety and Health 

Administration (OSHA) has a National 

Recognized Testing Laboratory (NRTL) 

program that uses ISO/IEC Guide 65’s 

requirements to review a laboratory’s 

independence. Rigorous evaluation of 

the independence of a laboratory should 

be required annually or at least with 

surveillance and reassessment visits, the 

commenter urged. 

Another commenter remarked that 

OSHA’s NRTL and the U.S. Federal 

Communications Commission’s (FCC’s) 

Telecommunications Body Certification 

(TBC) programs could be used as 

sources. 

Another commenter suggested that we 

consider the principles of product 

certification outlined in the American 

National Standards Institute document, 

titled, ‘‘National Conformity Assessment 

Principles for the United States.’’ The 

commenter said that manufacturer 

certification based on testing by 

laboratories accredited to ISO/IEC 

17025:2005 can ensure that a product 

conforms to a required standard at the 

time of testing, but it ‘‘does not ensure 

that the product continues to conform to 

the standard throughout production and 

distribution.’’ 

(Response 9)—The commenters may 

have misinterpreted the rule. 

Conformity assessment bodies test 

products, whereas domestic 

manufacturers and importers are 

responsible for certifying that their 

products comply with all rules, bans, 

standards, or regulations under the 

CPSA or any other Act enforced by the 

Commission under existing CPSC 

regulations at 16 CFR part 1110. 

Consequently, with respect to the 

comment regarding ISO/IEC Guide 65, 

we note that ISO/IEC Guide 65 provides 

requirements for certification bodies, 

which have different requirements and 

responsibilities than third party 

conformity assessment bodies (which, 

under section 14 of the CPSA and our 

regulations at 16 CFR part 1110, test 

children’s products but do not issue 

certificates for such products), including 

attestations of conformity and 

surveillance activities. The 

requirements to protect impartiality and 

conflict of interest in ISO/IEC Guide 65 

are tailored toward those functions. 


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As for the suggestion that a 

conformity assessment body submit 

evidence of its fulfillment of ISO/IEC 

17025:2005 section 4.1.5.b. as part of its 

application to the CPSC, both initially 

and with ongoing audits, section 102(c) 

of the CPSIA states that in establishing 

standards for accreditation of a third 

party conformity assessment body, the 

Commission may consider standards 

and protocols for accreditation of such 

conformity assessment bodies by 

independent accreditation organizations 

that are in effect on the date of 

enactment (August 14, 2008). 

Accreditation of third party conformity 

assessment bodies may be conducted 

either by the Commission or by an 

independent accreditation organization 

designated by the Commission. In our 

notices of requirements for the 

accreditation of third party conformity 

assessment bodies, we have established 

accreditation to ISO/IEC 17025:2005, 

with the accreditation conducted by an 

accreditation body that is a signatory to 

the ILAC–MRA as a baseline 

requirement for accreditation. Thus, we 

have designated accreditation 

organizations (accreditation bodies) to 

conduct accreditation of third party 

conformity assessment bodies. Records 

related to accreditation assessments and 

reassessments are maintained by the 

accreditation bodies and the third party 

conformity assessment bodies. 

Consequently, the commenter’s 

suggestion regarding evidence of a third 

party conformity assessment body’s 

fulfillment of ISO/IEC 17025:2005 

requirements is unnecessary because 

§ 1112.39 requires a third party 

conformity assessment body to retain 

records related 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), as well as the corrective 

actions, must be made available upon 

the CPSC’s request. 

In addition, § 1112.37 requires the 

quality manager at the third party 

conformity assessment body to notify 

the CPSC within five business days of 

an accreditation body’s notification of 

suspension, reduction, or withdrawal of 

accreditation. Failure to do so may lead 

to CPSC withdrawal of the laboratory as 

a CPSC-recognized third party 

conformity assessment body. 

As for the comment regarding a 

product’s continued conformity to 

standards throughout the product’s 

production and distribution, such 

matters are outside the scope of this 

audit rule; instead, they are addressed 

in a separate rulemaking pertaining to 

‘‘Testing and Labeling Pertaining to 

Product Certification’’ (75 FR 28336 

(May 20, 2010); 76 FR 69482 (November 

8, 2011)). 

b. § 1112.33(b)—Who conducts the 

reassessment portion of the audit? 

Proposed § 1112.7(b) (now 

renumbered as § 1112.33(b) in the final 

rule) would require the third party 

conformity assessment body to have the 

accreditation body that accredited the 

third party conformity assessment body 

perform the reassessment portion of the 

audit. For example, if a third party 

conformity assessment body was 

accredited for a particular scope by an 

accreditation body named AB–1, then 

AB–1 would conduct the reassessment. 

If, however, the same third party 

conformity assessment body changes its 

accreditation for the same scope, such 

that it becomes accredited by a different 

accreditation body, named AB–2, then 

AB–2 would conduct the reassessment. 

The preamble to the proposed rule 

also suggested that accreditation bodies 

performing reassessments conform to 

ISO/IEC 17011 titled, ‘‘Conformity 

Assessment—General Requirements for 

Accreditation Bodies Accrediting 

Conformity Assessment Bodies’’ (74 FR 

at 40787). The preamble to the proposed 

rule stated that certain provisions in 

ISO/IEC 17011, notably sections 7.11, 

‘‘Reassessment and Surveillance’’; 7.12, 

‘‘Extending Accreditation’’; and 7.13, 

‘‘Suspending, Withdrawing, or 

Reducing Accreditation,’’ may be 

relevant, particularly when conducting 

a reassessment (id.). 

(Comment 10)—One commenter 

stated that only a fraction of the many 

tests which a conformity assessment 

body may be accredited to perform 

actually are examined during any single 

reassessment. The commenter said it is 

up to the accreditation body performing 

the reassessment to decide which tests 

to undertake. In addition, the 

commenter asked whether a conformity 

assessment body must insist that the 

accreditation body reassess every two 

years all CPSC tests to which the 

conformity assessment body is 

accredited. 

(Response 10)—The commenter may 

have confused reassessment with 

surveillance. ISO/IEC 17011 defines 

‘‘assessment’’ as ‘‘a process undertaken 

by an accreditation body to assess the 

competence of a conformity assessment 

body, based on particular standard(s) 

and/or other normative documents and 

for a defined scope of accreditation.’’ 

(See ISO/IEC 17011:2004, Conformity 

assessment—General requirements for 

accreditation bodies accrediting 

conformity assessment bodies, at section 

3.7.) Assessing the competence of a 

conformity assessment body involves 

assessing the competence of all 

conformity assessment body operations, 

including (among other things) the 

competence of the personnel, the 

validity of the conformity assessment 

methodology, and the validity of the 

conformity assessment results. 

Reassessment is described as similar to 

an initial assessment, except that 

experience gained during previous 

assessments shall be taken into account. 

(Id. at section 7.11.1.) The outcome of 

these different approaches is the same 

in that the accreditation body must 

demonstrate that it has assessed 

adequately each of the third party 

conformity assessment body’s 

competencies (including technical and 

management systems competencies) 

over the reassessment period. 

‘‘Surveillance’’ is defined as ‘‘a set of 

activities, except reassessment, to 

monitor the continued fulfillment by 

accredited CABs of requirements for 

accreditation’’ (id. at section 3.18). 

Typically, surveillance consists of a 

subset of the reassessment activities, 

and it is conducted between 

reassessments. 

We note that, on our own initiative, 

we have revised the last sentence in 

§ 1112.33(b), by inserting a comma 

between ‘‘changes it accreditation’’ and 

‘‘so that it becomes accredited. * * *’’ 

This change is for grammatical 

purposes. 

c. § 1112.33(c)—What is the 

examination portion of the audit? 

As for the examination portion of the 

audit, proposed § 1112.7(c) (now 

renumbered as § 1112.33(c) in the final 

rule) would explain that the third party 

conformity assessment body must have 

the examination portion of the audit 

conducted by the Commission. The 

examination portion of the audit would 

consist of resubmission of CPSC Form 

223 by the third party conformity 

assessment body to the CPSC and the 

CPSC’s examination of the resubmitted 

form. Resubmission of the CPSC Form 

223 would occur in two ways: (1) There 

would be a continuing obligation to 

ensure that the information submitted 

on CPSC Form 223 is current, such that 

a third party conformity assessment 

body would submit a new CPSC Form 

223 whenever the information changes; 

and (2) In the absence of any changes 

that would necessitate the submission of 

a new CPSC Form 223, the third party 

conformity assessment body would 

reregister at the CPSC every 2 years, 

using CPSC Form 223. 


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Additionally, proposed § 1112.7(c) 

would contain specific requirements for 

the CPSC’s examination of ‘‘firewalled’’ 

and government-owned or governmentcontrolled conformity assessment 

bodies. For ‘‘firewalled’’ conformity 

assessment bodies, proposed 

§ 1112.7(c)(1) would state that the 

examination portion of the audit 

conducted by the CPSC may include 

verification to ensure that the 

‘‘firewalled’’ conformity assessment 

body continues to meet the criteria set 

forth in section 14(f)(2)(D) of the CPSA. 

Thus, for example, under proposed 

§ 1112.7(c)(1), we could examine 

whether a ‘‘firewalled’’ conformity 

assessment body’s established 

procedures continue to exist; and 

likewise, it could review its 

mechanisms for confidential reporting 

of allegations of undue influence. For 

government-owned or governmentcontrolled conformity assessment 

bodies, proposed § 1112.7(c)(2) would 

state that the examination portion of the 

audit conducted by the CPSC may 

include verification that the 

government-owned or governmentcontrolled conformity assessment body 

continues to meet the five criteria set 

forth in section 14(f)(2)(B) of the CPSA. 

Thus, for example, under proposed 

§ 1112.7(c)(2), the CPSC could examine 

whether a government-owned 

conformity assessment body has 

procedures in place to ensure that its 

testing results are not subject to undue 

influence by any other person. 

We received no comments on this 

provision, and aside from renumbering 

it as § 1112.33(c), we finalized the 

provision without change. Elsewhere in 

this issue of the Federal Register, 

however, we have published a proposed 

rule to establish other requirements 

pertaining to third party conformity 

assessment bodies (such as the 

requirements for accreditation and 

provisions for the withdrawal and 

suspension of third party conformity 

assessment bodies). The proposed rule 

would establish different requirements 

on the resubmission of CPSC Form 223, 

by asking for additional documentation 

to support CPSC Form 223. 

5. § 1112.35—When must an audit be 

conducted? 

Proposed § 1112.9(a) (now 

renumbered as § 1112.35 in the final 

rule) would state that, at a minimum, 

each third party conformity assessment 

body must be reassessed at the 

frequency established by its 

accreditation body for reassessments of 

the accreditation. For example, if the 

accreditation body would conduct a 

reassessment to reexamine a third party 

conformity assessment body’s 

accreditation after 2 years, the minimum 

reassessment frequency for that third 

party conformity assessment body 

would be 2 years. 

As for the examination portion of the 

audit conducted by the CPSC, proposed 

§ 1112.9(b)(1) would require each third 

party conformity assessment body to 

ensure that the information it submitted 

on CPSC Form 223 is current and 

submit a new CPSC Form 223 whenever 

the information, such as the third party 

conformity assessment body’s address, 

telephone number, or ownership, 

changes. In the absence of any changes 

that would necessitate the submission of 

a new CPSC Form 223, proposed 

§ 1112.9(b)(2) would require the third 

party conformity assessment body to 

reregister at the CPSC every 2 years, 

using CPSC Form 223. 

On our own initiative, we have 

decided against issuing a final rule 

regarding the timing of the examination 

portion of the audit. After the 

publication of the proposed rule in the 

Federal Register on August 13, 2009, we 

have acquired more experience 

registering third party conformity 

assessment bodies and have made 

modifications to CPSC software, as well 

as to CPSC Form 223. This combination 

of experience and the modifications to 

the CPSC’s registration system have 

prompted us to reconsider when the 

examination portion of an audit should 

be conducted. Elsewhere in this issue of 

the Federal Register, we have published 

a proposed rule to establish other 

requirements pertaining to third party 

conformity assessment bodies; the 

proposed rule contains a new provision 

regarding the timing of the examination 

portion of the audit; and we believe that 

the new proposed provision is clearer 

and easier to implement. Therefore, 

rather than codify when the 

examination portion of an audit must be 

conducted, the final rule reserves 

§ 1112.35(b). 

6. § 1112.37—What must a third party 

conformity assessment body do after an 

audit? 

In general, once the accreditation 

body has conducted its reassessment of 

a third party conformity assessment 

body, the accreditation body will 

present its initial findings, along with 

any supporting evidence, to the quality 

manager for the third party conformity 

assessment body. The accreditation 

body may give the third party 

conformity assessment body’s personnel 

the opportunity to present any 

objections they have to the initial 

findings. The accreditation body may 

adjust its findings in response to any 

valid objections. 

When the accreditation body presents 

its findings to the third party conformity 

assessment body, proposed § 1112.11(a) 

would require the third party 

conformity assessment body’s quality 

manager to receive the findings and, if 

necessary, initiate corrective action in 

response to the findings. Proposed 

§ 1112.11(b) would require the quality 

manager to prepare a resolution report; 

the resolution report would identify the 

corrective actions taken and any followup activities. If immediate corrective 

action is necessary (as may be the case 

if the findings identify problems 

associated with incorrect procedures, 

invalid actions, or the creation or use of 

invalid data), proposed § 1112.11(b) 

would require the quality manager to 

document that they notified the relevant 

parties within the third party 

conformity assessment body to take 

immediate corrective action and also to 

document the action(s) taken. 

Proposed § 1112.11(c) would require 

the quality manager to notify the CPSC 

if the accreditation body decides to 

reduce, suspend, or withdraw the third 

party conformity assessment body’s 

accreditation and the reduction, 

suspension, or withdrawal of 

accreditation is relevant to the third 

party conformity assessment body’s 

activities pertaining to a CPSC 

regulation or test method. The 

notification would be sent to the 

Assistant Executive Director, Office of 

Hazard Identification and Reduction, 

within five business days of the 

accreditation body’s notification to the 

third party conformity assessment body. 

If a third party conformity assessment 

body does not notify the CPSC in the 

manner that proposed § 1112.11(c) 

would require, then such 

noncompliance may be grounds for 

withdrawal of acceptance of the 

accreditation by the Commission under 

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

failure to ‘‘comply with an applicable 

protocol, standard, or requirement 

established by the Commission’’ under 

the audit regulations. 

Proposed § 1112.11(d) would explain 

that the CPSC will notify the third party 

conformity assessment body if the CPSC 

finds that the third party conformity 

assessment body no longer meets the 

conditions contained in CPSC Form 223 

or in the relevant statutory provisions 

applicable to that third party conformity 

assessment body. The CPSC also will 

identify the condition or statutory 

provision that is no longer met, specify 

a time by which the third party 

conformity assessment body must notify 

the CPSC of the steps that it intends to 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 31081 

take to correct the deficiency, and 

indicate when it will complete such 

steps. Proposed § 1112.11(d) also would 

require the quality manager to 

document that they notified the relevant 

parties within the third party 

conformity assessment body to take 

corrective action and also document the 

action(s) taken. 

Proposed § 1112.11(e) would describe 

the possible consequences if a third 

party conformity assessment body fails 

to remedy the deficiency in a timely 

fashion. In brief, proposed § 1112.11(e) 

would state that the CPSC ‘‘shall take 

whatever action it deems appropriate 

under the circumstances, up to and 

including withdrawing the CPSC’s 

accreditation of the third party 

conformity assessment body or the 

CPSC’s acceptance of the third party 

conformity assessment body’s 

accreditation.’’ 

We received no comments on this 

provision, but we have renumbered the 

provision as § 1112.37 in the final rule. 

Additionally, on our own initiative, we 

have: 

• Revised the second sentence in 

§ 1112.37(b), by changing ‘‘he/she 

notified’’ to ‘‘they notified’’; 

• Revised the address in § 1112.37(c), 

to replace ‘‘Maryland’’ with ‘‘MD’’; and 

• Revised the next-to-last sentence in 

§ 1112.37(d), to change ‘‘correct the 

deficiency and when it will complete 

such steps’’ to ‘‘correct the deficiency, 

and indicate when it will complete such 

steps’’; and 

• Revised the last sentence in 

§ 1112.37(d), by changing ‘‘he/she 

notified’’ to ‘‘they notified * * *.’’ 

These changes are for grammatical 

purposes. 

7. § 1112.39—What records should a 

third party conformity assessment body 

retain regarding an audit? 

Proposed § 1112.13 (now renumbered 

as § 1112.39 in the final rule) would 

require a third party conformity 

assessment body to retain all records 

related to an audit and all records 

pertaining to the third party conformity 

assessment body’s resolution of, or 

plans for, resolving nonconformities 

identified by the audit. Such 

nonconformities could be identified 

through a reassessment by an 

accreditation body or through an 

examination by the CPSC. The proposal 

also would require third party 

conformity assessment bodies to retain 

records related to the last three 

reassessments (or however many 

reassessments have been conducted, if 

the third party conformity assessment 

body has been reassessed less than three 

times) and make such records available 

to the CPSC, upon request. 

The proposal also would require third 

party conformity assessment bodies to 

retain records related to the last three 

reassessments because such records may 

reveal whether a pattern of problems 

with accreditation exists, and the 

records may indicate how quickly such 

problems are addressed and resolved. 

(Comment 11)—One commenter 

noted that ISO/IEC 17011 requires the 

accreditation body, rather than the 

conformity assessment body, to keep 

records of reassessments. The 

commenter said that it would be a 

burden on the accreditation body to 

make duplicates of these records and 

provide them to the conformity 

assessment body. The commenter said 

that a third party conformity assessment 

body could meet the objectives for 

record retention by keeping records of 

resolutions of nonconformities. 

(Response 11)—It is not the intent of 

the recordkeeping provision for the 

conformity assessment body to make 

available to the CPSC all records 

associated with reassessments that are 

maintained by the accreditation body. 

However, assessment and reassessment 

records need to be retained by the 

conformity assessment body and made 

available, upon request, to the CPSC, 

and the records must include reports of 

nonconformities, as well as resolution of 

nonconformities. In addition, 

assessment/reassessment reports that 

the accreditation body provides to the 

conformity assessment body must be 

made available to the CPSC, upon 

request. 

Consequently, we have amended the 

rule to clarify that the records retained 

should include any records received 

from the accreditation body, as well as 

the records generated by the conformity 

assessment body (such as a resolution 

report discussed in § 1112.39) related to 

reassessment. Additionally, on our own 

initiative, and for grammatical purposes, 

we have revised the last sentence in 

§ 1112.39, by inserting a comma 

between ‘‘however many reassessments 

have been conducted’’ and ‘‘if the third 

party conformity assessment body has 

been reassessed less than three times’’ 

and by inserting another comma after 

‘‘available to the CPSC’’ and ‘‘upon 

request.’’ We also have changed the 

words ‘‘relating to’’ to ‘‘related to’’ 

throughout § 1112.39; these changes are 

for grammatical purposes only. 

B. General Comments 

Many comments pertained to issues 

outside the scope of the rule. For 

example, some comments addressed 

matters related to the initial 

accreditation of third party conformity 

assessment bodies. Other comments 

sought ‘‘reciprocity’’ between 

conformity assessment body 

(‘‘laboratory’’) programs administered 

by other federal agencies or other 

entities. We address those comments in 

this section. 

(Comment 12)—A commenter 

suggested that the CPSC include 

reciprocity provisions as part of its 

accreditation criteria for laboratories to 

ensure a level playing field for testing 

organizations based in the United States 

with respect to foreign competition. 

Another commenter suggested that the 

CPSC amend the proposed requirements 

to include reciprocity provisions drawn 

from OSHA’s NRTL and FCC’s TCB 

programs. The commenter argued that 

the CPSC would be putting in place a 

‘‘system of special privileges’’ that 

would damage laboratories in the 

United States because the third party 

conformity assessment body 

accreditation process is ‘‘open to all 

countries while other countries’ 

conformity assessment systems are not 

open to U.S.-based laboratories,’’ thus 

creating ‘‘a one-way trading relationship 

and does not advantage all in the supply 

chain.’’ Another commenter expressed 

concern about a lack of reciprocity 

requirements, stating that foreign 

countries that wish to participate in a 

third party conformity assessment body 

program should be ‘‘mandated to offer 

recognition to U.S.-based laboratories 

for its certification programs.’’ 

(Response 12)—We decline to revise 

the rule as suggested by the 

commenters. Issues regarding 

reciprocity, either of laboratory 

accreditation or test results, are outside 

the scope of this rule. Nothing in section 

14(i)(1) of the CPSA authorizes the 

Commission to include reciprocity of 

laboratory accreditations or test results 

as falling within a ‘‘periodic audit of 

third party conformity assessment 

bodies as a condition for the continuing 

accreditation of such conformity 

assessment bodies under [section 

14(a)(3)(C) of the CPSA].’’ Furthermore, 

we do not believe that we have the legal 

authority to impose a requirement on 

foreign governments. 

(Comment 13)—One commenter 

expressed opposition to having 

accreditation by a signatory to the 

ILAC–MRA. The commenter said there 

is no reciprocal agreement with ILAC 

countries to accept accreditations by the 

American National Standards Institute, 

OSHA, or the Standards Council of 

Canada. The commenter said such 

acceptance by the CPSC would help to 

ensure the impartiality of certification. 


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(Response 13)—As explained in more 

detail in the response to Comment 6 

above, accreditation by a signatory to 

the ILAC–MRA ensures some degree of 

similarity or uniformity among 

accreditation bodies, regardless of their 

geographical location, and it also 

ensures uniformity among third party 

conformity assessment bodies 

accredited by ILAC–MRA accreditation 

bodies. While the commenter is correct 

that there is no reciprocal agreement 

with ILAC countries to accept certain 

accreditations by entities in the United 

States or Canada, we do not believe that 

the audit requirement in the CPSIA 

gives the Commission the authority to 

demand reciprocity from foreign 

countries as a function of the audit 

process. An international agreement of 

that type is beyond the scope of this 

rulemaking. 

As for the impartiality of certification, 

we note that the CPSA does not require 

conformity assessment bodies to issue 

certificates. Instead, under existing 

CPSC regulations at 16 CFR part 1110, 

domestic manufacturers and importers 

issue certificates. 

(Comment 14)—One commenter 

noted that, in some ‘‘systems,’’ the same 

government entity is responsible for 

accreditation, testing, and certification. 

The commenter said that sections 

14(f)(2)(B)(i) through (f)(2)(B)(v) of the 

CPSA (which lists the criteria for 

Commission acceptance of 

governmental conformity assessment 

bodies) should require extensive 

documentation during initial acceptance 

and during audits. 

(Response 14)—The commenter did 

not elaborate on or describe what 

documentation would be necessary. In 

any event, the commenter’s focus 

appears to be on revising the statutory 

or administrative criteria pertaining to 

government-owned or governmentcontrolled conformity assessment 

bodies, rather than revising the 

proposed audit requirements. Thus, the 

comment is outside the scope of the 

rule. 

(Comment 15)—One commenter 

stated that a Government Accountability 

Office (GAO) report issued in August 

2009, assessing the effectiveness of 

enforcement of the CPSC’s 

requirements, identified some resource 

limitations that could affect our ability 

to address and enforce requirements on 

foreign laboratories (both governmentowned or government-controlled and 

firewalled conformity assessment 

bodies). 

(Response 15)—The commenter may 

have confused laboratories whose tests 

form the basis for a manufacturer or 

importer to issue a children’s product 

certificate, with CPSC laboratory testing 

in support of its import surveillance 

activities. The GAO report titled, ‘‘Better 

Information and Planning Would 

Strengthen CPSC’s Oversight of 

Imported Products,’’ GAO–09–803 

(available on the Internet at http:// 

www.gao.gov/new.items/d09803.pdf), 

refers to overseas manufacturers whose 

products are imported into the United 

States and are tested by the CPSC at our 

laboratory facilities. The GAO report 

does not discuss accreditation or audit 

requirements for laboratories. 

Accordingly, issues regarding the GAO 

report are outside the scope of this rule. 

(Comment 16)—One commenter 

suggested that to alleviate uncertainty 

and confusion, the CPSC should address 

the lack of a definition for a ‘‘reasonable 

testing program.’’ 

(Response 16)—This comment is 

outside the scope of the audit provisions 

of section 14(i)(1) of the CPSA. This 

rulemaking implements section 14(i)(1) 

of the CPSA. A ‘‘reasonable testing 

program’’ is part of section 14(a)(1) of 

the CPSA, and we note that, in the 

Federal Register of May 20, 2010 (75 FR 

28336), we published a proposed rule 

on ‘‘Testing and Labeling Pertaining to 

Product Certification.’’ The proposed 

rule contained (among other things) 

requirements for a ‘‘reasonable testing 

program.’’ However, in the final rule on 

‘‘Testing and Labeling Pertaining to 

Product Certification’’ (76 FR 69482 

(November 8, 2011)), we decided to 

reserve, rather than finalize, the 

‘‘reasonable testing program’’ 

requirements. Thus, issues related to a 

‘‘reasonable testing program’’ are part of 

a separate rulemaking. 

(Comment 17)—One commenter 

suggested that the CPSC reassert that 

compliance to the CPSIA is the 

manufacturer’s responsibility, not the 

retailer’s, and that retailers must accept 

testing from any accredited third party 

conformity assessment body approved 

by the CPSC. 

(Response 17)—Current CPSC 

regulations, at 16 CFR part 1110, limit 

the persons required to comply with the 

certification requirements of section 

14(a) of the CPSA to: the importer (for 

products manufactured outside of the 

United States) and to the domestic 

manufacturer (for products 

manufactured within the United States). 

Neither the CPSIA, nor the CPSA, 

require a retailer to accept product 

testing results from any accredited third 

party conformity assessment body 

whose accreditation is accepted by the 

CPSC. 

Additionally, as we noted in the 

preamble to our proposed rule on 

‘‘Testing and Labeling Pertaining to 

Product Certification’’ (75 FR 28336, 

28337 (May 20, 2010)): 

The Commission understands the 

economic ramifications that small businesses 

(and even large businesses) face regarding the 

testing costs required by section 102 of the 

CPSIA. Moreover, retailers and importers 

may be imposing significant additional 

testing cost on manufacturers by requiring 

that products that have already been tested 

by a third party conformity assessment body 

be tested again by a specific third party 

conformity assessment body selected by the 

retailer or importer. The Commission wants 

to emphasize to retailers and sellers of 

children’s products that they can rely on 

certificates provided by product suppliers if 

those certificates are based on testing 

conducted by a third party conformity 

assessment body. Section 19(b) of the CPSA 

provides that a retailer or seller of a 

children’s product shall not be subject to 

civil or criminal penalties for selling 

products that do not comply with applicable 

safety standards if it holds a certificate issued 

in accordance with section 14(a) of the CPSA 

to the effect that such consumer product 

conforms to all applicable consumer product 

safety rules, unless such person knows that 

such consumer product does not conform. 

The Commission notes that section 19(b) of 

the CPSA does not relieve any person of the 

obligation to conduct a corrective action 

should any product violate an applicable 

safety standard and need to be recalled. 

III. Paperwork Reduction Act 

The final 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). 

The OMB has approved the 

information collection requirements in 

this rule. The OMB control number 

pertaining to such approval is OMB 

3041–0140, and it expires on December 

31, 2012. 

IV. Regulatory Flexibility Act 

The CPSC has examined the impacts 

of the final rule under the Regulatory 

Flexibility Act (5 U.S.C. 601–612). The 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would minimize any significant 

impact of a rule on small entities. 

Because the required information is 

minimal, and the costs associated with 

the audits are low, the Commission 

certifies that the final rule would not 

have a significant economic impact on 

a substantial number of small entities. 

A. Objectives and Legal Basis for the 

Final Rule 

Section 14(i)(1) of the CPSA requires 

the Commission to establish 

requirements for the periodic audit of 

third party conformity assessment 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 31083 

bodies as a condition of their continuing 

accreditation. The final rule implements 

the requirements for the periodic audits. 

The purpose of a periodic audit is to 

ensure that an accredited laboratory 

continues to be competent to perform 

the testing services for which it has been 

accredited. In the case of accredited 

third party conformity assessment 

bodies that are owned, managed, or 

controlled by a manufacturer (or 

‘‘firewalled laboratories’’), or that are 

owned or controlled, in whole or in 

part, by a government entity, the audit 

requirements give the Commission the 

opportunity to ensure that the third 

party conformity assessment body 

continues to comply with the CPSIA’s 

requirements for ‘‘firewalled’’ and 

government-owned or governmentcontrolled conformity assessment 

bodies. 

B. Firms Subject to the Requirement for 

Periodic Audits 

The requirement for periodic audits 

will affect only third party conformity 

assessment bodies that intend to 

provide the CPSIA-required third party 

conformity assessment services for 

manufacturers or private labelers of 

children’s products. Third party 

conformity assessment bodies that do 

not intend to offer third party 

conformance testing for children’s 

products are not affected by the 

requirements for accreditation or 

periodic audits. 

As of August 29, 2011, the CPSC had 

accepted the accreditations of 87 third 

party conformity assessment bodies 

located within the United States. 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 (which the Commission issued 

pending clarification of the regulations 

and testing requirements) are lifted. Of 

the third party conformity assessment 

bodies located in the United States with 

CPSC-accepted accreditations, 12 are 

owned by large, foreign-based 

companies; 22 are large, U.S.-based 

companies; and the remaining 53 could 

be small businesses, according to the 

criteria established by the U.S. Small 

Business Administration (SBA), which, 

for a testing laboratory (NAICS code 

54138), is a company with less than $12 

million in annual revenue. 

C. Requirements of the Final Rule and 

Possible Impacts on Small Businesses 

The notices of requirements issued by 

the CPSC for the accreditation of third 

party conformity assessment bodies 

state, as a baseline requirement, that 

third party conformity assessment 

bodies must be accredited by an 

accreditation body that is a signatory to 

the ILAC–MRA. ILAC is an international 

cooperation of laboratory accreditation 

bodies that seek to harmonize laboratory 

accreditation procedures to facilitate the 

acceptance of the testing results of 

accredited laboratories within and 

across national boundaries. The ILAC– 

MRA includes requirements for the 

initial assessment of laboratories, as 

well as periodic reassessments. 

Laboratories that do not submit to the 

periodic reassessments lose their 

accredited status. 

Under the final rule, the periodic 

audit of a third party conformity 

assessment body would consist of two 

parts. The first part would be a 

reassessment by the accreditation body 

to determine whether it continues to 

meet the conditions of accreditation. 

The second part of the audit would be 

the resubmission to the CPSC of CPSC 

Form 223 and its review by the CPSC. 

All signatories to the ILAC–MRA have 

requirements for the periodic 

reassessment of accredited laboratories. 

The ILAC–MRA harmonized procedures 

for surveillance and reassessment of 

accredited laboratories and 

recommended that the time between 

reassessments be no more than 60 

months, provided that the accreditation 

body undertakes somewhat less 

comprehensive surveillance visits at 

least every 18 months. However, many 

accreditation bodies opt to undertake 

more frequent full reassessments, rather 

than conduct surveillance visits. 

According to ISO/IEC 17011, if an 

accreditation body does not conduct 

surveillance visits, full reassessments of 

accredited laboratories must take place 

at least once every 2 years. 

The resubmission of CPSC Form 223 

is intended to provide the Commission 

with an opportunity to ensure that the 

third party conformity assessment body 

continues to be accredited by an ILAC– 

MRA signatory and continues to comply 

with the requirements for firewalled and 

government-owned or controlled 

conformity assessment bodies, if 

applicable. However, because CPSC 

staff, in light of its experience with the 

accreditation process and software 

changes, has reconsidered when the 

form should be submitted, and 

therefore, the final rule does not state 

when the CPSC Form 223 must be 

resubmitted. Instead, such matters will 

be addressed in a separate rulemaking. 

Costs associated with periodic audits 

include: The time cost of the assessor 

from the accreditation body; and his or 

her travel, lodging, and meal expenses 

incurred while conducting the 

reassessment. According to an 

accreditation body representative, a 

reassessment typically takes 2 to 3 days; 

and the cost charged to the third party 

conformity assessment body usually 

will be $3,000 to $4,000 per field (e.g., 

chemical, electrical, or mechanical 

testing) in which the third party 

conformity assessment body is 

accredited. Therefore, a third party 

conformity assessment body that is 

accredited for testing conformance to 

both chemical and mechanical 

standards could expect an assessment or 

reassessment to cost $6,000 to $8,000. 

Another expense of a reassessment by 

an accreditation body is the cost of the 

time spent by third party conformity 

assessment body personnel to cooperate 

with the assessors. This includes the 

time required to prepare or assemble 

documents needed by the auditors, as 

well as the time it takes to explain or 

demonstrate the procedures used at the 

third party conformity assessment body. 

No empirical estimates of this cost were 

found; however, the amount of time 

spent by third party conformity 

assessment body personnel during a 

reassessment could be close to the 

amount of time spent by the assessor. If 

the average reassessment takes 2.5 days 

(or 20 hours), and the wage of the 

employees involved is about $44 an 

hour, then the cost of the time of the 

third party conformity assessment 

body’s personnel spent cooperating with 

the reassessment would be about $880. 

The median hourly wage of architecture 

and engineering occupations in testing 

laboratories (NAICS code 541380) is 

$31.65. U.S. Department of Labor, 

Bureau of Labor Statistics, National 

Occupational Employment and Wage 

Estimates, May 2008 (http:// 

www.bls.gov/oes/oes_dl.htm). In 2008, 

wages and salaries represented about 

71.9 percent of total compensation for 

professional and related occupations in 

private industry (U.S. Department of 

Labor, Bureau of Labor Statistics, 

Employer cost for Employee 

Compensation (data extracted on June 

17, 2009)).) The cost could be higher if 

the reassessment takes longer than 2.5 

days or higher-paid employees are 

involved in the reassessment. 

The periodic audits required would 

cost third party conformity assessment 

bodies about $4,000 to $5,000 (rounded 

to the nearest thousand) per field in 

which the third party conformity 

assessment body is accredited. This 

expense includes the cost of the 

accreditation body’s assessors, as well 

as the third party conformity assessment 

body personnel’s time spent on the 

assessments and other costs, such as the 

cost of providing the materials required 


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31084 Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 

of ‘‘firewalled’’ conformity assessment 

bodies. The time between audits will 

vary to some degree among 

accreditation bodies; however, a typical 

period is about once every 2 years. 

Therefore, the annual average cost of the 

periodic audits would be approximately 

$2,000 to $2,500 per field in which the 

third party conformity assessment body 

is accredited. Therefore, the annual cost 

to a third party conformity assessment 

body accredited in three fields (e.g., 

chemical, mechanical, and electrical) 

would be approximately $6,000 to 

$7,500. 

As noted earlier, of the third party 

conformity assessment bodies based in 

the United States, for which the CPSC 

has recognized accreditations, 43 (or 

about 62 percent) appear to be small 

businesses, according to the SBA 

criteria. However, it is unlikely that the 

rule will have a significant adverse 

impact on many third party conformity 

assessment bodies. The only third party 

conformity assessment bodies that will 

seek accreditation for testing children’s 

products are those that expect to receive 

substantial revenue from the third party 

testing requirement in the CPSA, as 

amended by the CPSIA. Those third 

party conformity assessment bodies that 

do not expect substantial revenue from 

the testing will not seek to be accredited 

for the testing, or they can choose not 

renew their accreditation—if they 

initially sought accreditation—but the 

revenue they expected did not 

materialize. 

D. Alternatives to the Final Rule 

Considered 

Given that the CPSC is relying upon 

accreditation bodies that are signatories 

to the ILAC–MRA to accredit and 

reassess the third party conformity 

assessment bodies, there are no realistic 

alternatives to the final rule that would 

lower substantially the cost of the 

periodic audits. The frequency of the 

reassessments of the third party 

conformity assessment bodies is 

determined by the accreditation bodies, 

not by the CPSC. 

V. Environmental Considerations 

This final rule falls within the scope 

of the Commission’s environmental 

review regulations at 16 CFR 

§ 1021.5(c)(2), which provide a 

categorical exclusion from any 

requirement for the agency to prepare an 

environmental assessment or 

environmental impact statement for 

product certification rules. 

VI. Effective Date 

The final rule becomes effective on 

July 23, 2012. 

List of Subjects in 16 CFR Part 1112 

Consumer protection, Third party 

conformity assessment body, Audit. 

For the reasons stated above, the 

Commission amends Title 16 of the 

Code of Federal Regulations by adding 

a new part 1112, subpart A and subpart 

C, to read as follows: 

PART 1112—REQUIREMENTS 

PERTAINING TO THIRD PARTY 

CONFORMITY ASSESSMENT BODIES 

Sec. 

Subpart A—Purpose and Definitions 

1112.1 [Reserved] 

1112.3 Definitions. 

1112.1 [Reserved] 

Subpart B—[Reserved] 

Subpart C—Audit Requirements for Third 

Party Conformity Assessment Bodies 

1112.30 What is the purpose of this 

subpart? 

1112.31 Who is subject to these audit 

requirements? 

1112.33 What must an audit address or over 

and who conducts the audit? 

1112.35 When must an audit be conducted? 

1112.37 What must a third party conformity 

assessment body do after an audit? 

1112.39 What records should a third party 

conformity assessment body retain 

regarding an audit? 

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

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

Subpart A—Purpose and Definitions 

§ 1112.3 Definitions. 

Unless otherwise stated, the 

definitions of section 3 of the CPSA and 

additional definitions in the Consumer 

Product Safety Improvement Act of 

2008, Public Law 110–314, apply for 

purposes of this part. The following 

definitions apply for purposes of this 

subpart: 

Accreditation means a procedure by 

which an authoritative body gives 

formal recognition that a third party 

conformity assessment body meets 

competence requirements to perform 

specific tasks. Accreditation recognizes 

a third party conformity assessment 

body’s technical capability and is 

usually specific for tests of the systems, 

products, components, or materials for 

which the third party conformity 

assessment body claims proficiency. 

Accreditation body means an entity 

that: 

(1) Accredits or has accredited a third 

party conformity assessment body as 

meeting, at a minimum, the 

International Organization for 

Standardization (ISO)/International 

Electrotechnical Commission (IEC) 

Standard ISO/IEC 17025:2005, ‘‘General 

Requirements for the Competence of 

Testing and Calibration Laboratories,’’ 

and any test methods or consumer 

product safety requirements specified in 

the relevant notice of requirements 

issued by the Commission; and 

(2) Is a signatory to the International 

Laboratory Accreditation Cooperation– 

Mutual Recognition Arrangement. 

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) 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 governmentcontrolled 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. 

CPSC means the Consumer Product 

Safety Commission. 

Quality manager means an individual 

(however named) who, irrespective of 

other duties and responsibilities, has 

defined responsibility and authority for 

ensuring that the management system 

related to quality is implemented and 

followed at all times and has direct 

access to the highest level of 

management at which decisions are 

made on the conformity assessment 

body’s policy or resources. 

Subpart B—[Reserved] 

Subpart C—Audit Requirements for 

Third Party Conformity Assessment 

Bodies 

§ 1112.30 What is the purpose of this 

subpart? 

This subpart establishes the audit 

requirements for third party conformity 

assessment bodies pursuant to section 


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Federal Register / Vol. 77, No. 101 / Thursday, May 24, 2012 / Rules and Regulations 31085 

14(i)(1) of the Consumer Product Safety 

Act (CPSA) (15 U.S.C. 2063(i)(1)). 

Compliance with these requirements is 

a condition of the continuing 

accreditation of such third party 

conformity assessment bodies pursuant 

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

However, this subpart does not apply to 

certifying organizations under the 

Labeling of Hazardous Art Materials 

Act, even if such organizations are third 

party conformity assessment bodies. 

§ 1112.31 Who is subject to these audit 

requirements? 

Except for certifying organizations 

described in 16 CFR 1500.14(b)(8), these 

audit requirements apply to third party 

conformity assessment bodies operating 

pursuant to section 14(a)(2) of the 

CPSA. Third party conformity 

assessment bodies must comply with 

the audit requirements as a continuing 

condition of the CPSC’s acceptance of 

their accreditation. 

§ 1112.33 What must an audit address or 

cover and who conducts the audit? 

(a) The reassessment portion of an 

audit must cover management 

requirements and technical 

requirements. Each reassessment 

portion of an audit also must examine 

the third party conformity assessment 

body’s management systems to ensure 

that the third party conformity 

assessment body is free from any undue 

influence regarding its technical 

judgment. 

(b) The third party conformity 

assessment body must have the 

reassessment portion of the audit 

conducted by the same accreditation 

body that accredited the third party 

conformity assessment body. For 

example, if a third party conformity 

assessment body was accredited by an 

accreditation body named AB–1, then 

AB–1 would conduct the reassessment. 

If, however, the same third party 

conformity assessment body changes its 

accreditation so that it becomes 

accredited by a different accreditation 

body named AB–2, then AB–2 would 

conduct the reassessment. 

(c) The third party conformity 

assessment body must have the 

examination portion of the audit 

conducted by the CPSC. The 

examination portion of the audit will 

consist of resubmission of the 

‘‘Consumer Product Conformity 

Assessment Body Acceptance 

Registration Form’’ (CPSC Form 223) by 

the third party conformity assessment 

body and the CPSC’s examination of the 

resubmitted CPSC Form 223. 

(1) For ‘‘firewalled’’ conformity 

assessment bodies, the CPSC’s 

examination may include verification to 

ensure that the ‘‘firewalled’’ conformity 

assessment body continues to meet the 

criteria set forth in section 14(f)(2)(D) of 

the CPSA. 

(2) For government-owned or 

government-controlled conformity 

assessment bodies, the CPSC’s 

examination may include verification to 

ensure that the government-owned or 

government-controlled conformity 

assessment body continues to meet the 

criteria set forth in section 14(f)(2)(B) of 

the CPSA. 

§ 1112.35 When must an audit be 

conducted? 

(a) At a minimum, each third party 

conformity assessment body must be 

reassessed at the frequency established 

by its accreditation body. 

(b) [Reserved] 

§ 1112.37 What must a third party 

conformity assessment body do after an 

audit? 

(a) When the accreditation body 

presents its findings to the third party 

conformity assessment body, the third 

party conformity assessment body’s 

quality manager must receive the 

findings and, if necessary, initiate 

corrective action in response to the 

findings. 

(b) The quality manager must prepare 

a resolution report identifying the 

corrective actions taken and any followup activities. If findings indicate that 

immediate corrective action is 

necessary, the quality manager must 

document that they notified the relevant 

parties within the third party 

conformity assessment body to take 

immediate corrective action and also 

document the action(s) taken. 

(c) If the accreditation body decides to 

reduce, suspend, or withdraw the third 

party conformity assessment body’s 

accreditation, and the reduction, 

suspension, or withdrawal of 

accreditation is relevant to the third 

party conformity assessment body’s 

activities pertaining to a CPSC 

regulation or test method, the quality 

manager must notify the CPSC. Such 

notification must be sent to the 

Assistant Executive Director, Office of 

Hazard Identification and Reduction, 

Consumer Product Safety Commission, 

4330 East West Highway, Bethesda, MD 

20814, within five business days of the 

accreditation body’s notification to the 

third party conformity assessment body. 

(d) If the CPSC finds that the third 

party conformity assessment body no 

longer meets the conditions specified in 

CPSC Form 223, or in the relevant 

statutory provisions applicable to that 

third party conformity assessment body, 

the CPSC will notify the third party 

conformity assessment body, identify 

the condition or statutory provision that 

is no longer met, and specify a time by 

which the third party conformity 

assessment body shall notify the CPSC 

of the steps it intends to take to correct 

the deficiency, and indicate when it will 

complete such steps. The quality 

manager must document that they 

notified the relevant parties within the 

third party conformity assessment body 

to take corrective action and also 

document the action(s) taken. 

(e) If the third party conformity 

assessment body fails to remedy the 

deficiency in a timely fashion, the CPSC 

shall take whatever action it deems 

appropriate under the circumstances, up 

to and including withdrawing the 

CPSC’s accreditation of the third party 

conformity assessment body or the 

CPSC’s acceptance of the third party 

conformity assessment body’s 

accreditation. 

§ 1112.39 What records should a third 

party conformity assessment body retain 

regarding an audit? 

A third party conformity assessment 

body must retain all records related to 

an audit that it receives from an 

accreditation body regarding a 

reassessment and all records pertaining 

to the third party conformity assessment 

body’s resolution of, or plans for, 

resolving nonconformities identified 

through a reassessment by an 

accreditation body or through an 

examination by the CPSC. A third party 

conformity assessment body also must 

retain such records related to the last 

three reassessments (or however many 

reassessments have been conducted, if 

the third party conformity assessment 

body has been reassessed less than three 

times) and make such records available 

to the CPSC, upon request. 

Todd A. Stevenson, 

Secretary. 

[FR Doc. 2012–10922 Filed 5–23–12; 8:45 am] 

BILLING CODE 6355–01–P 


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