Vol. 78 Tuesday, 

No. 48 March 12, 2013 

Part III 

Consumer Product Safety Commission 

16 CFR Parts 1112 and 1118 

Requirements Pertaining to Third Party Conformity Assessment Bodies; 

Final Rule 


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15836 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 

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: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (CPSC, Commission, or we) 

is issuing a final rule establishing 

requirements pertaining to the third 

party conformity assessment bodies 

(laboratories) whose accreditations are 

accepted 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 final rule establishes 

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 addresses 

adverse actions that may be imposed 

against CPSC-accepted third party 

conformity assessment bodies. The final 

rule also amends the audit requirements 

for third party conformity assessment 

bodies and amends the Commission’s 

regulation on inspections. 

DATES: The rule is effective June 10, 

2013 and applies to products 

manufactured on or after that date. The 

incorporation by reference of the 

publications listed in this rule is 

approved by the Director of the Federal 

Register as of June 10, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Scott Heh, Office of Hazard 

Identification and Reduction, U.S. 

Consumer Product Safety Commission, 

5 Research Place, Rockville, MD 20850; 

301–504–7646; email: sheh@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Introduction 

On May 24, 2012, the Commission 

published a notice of proposed 

rulemaking to establish requirements for 

third party conformity assessment 

bodies whose accreditations are 

accepted to test children’s products in 

support of the certification that the 

CPSA requires. As explained in the 

following section, the CPSA requires 

that certain children’s products must be 

tested by a third party conformity 

assessment body (also sometimes called 

a laboratory), and the manufacturer or 

private labeler of that product must 

issue a certificate, based on the third 

party testing, stating that the product 

meets all applicable CPSC requirements. 

This rule finalizes the proposal 

published on May 24, 2012. 

B. 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 (this term 

includes 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 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). 

As noted above, 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 

(this term includes the importer) 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 it 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. 

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

provides that the Commission may 

either accredit laboratories itself, or it 

may designate an independent 

accreditation organization to conduct 

the accreditations. Section 14(a)(3)(E) of 

the CPSA requires that the Commission 

maintain on its Web site an up-to-date 

list of entities that have been accredited 

to assess conformity with children’s 

product safety rules. 

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

the Commission to establish 

‘‘requirements for the periodic audit of 

third party conformity assessment 

bodies as a condition for the continuing 

accreditation of such conformity 

assessment bodies’’ under section 

14(a)(3)(C) of the CPSA. Section 14(e) of 

the CPSA addresses Commission 

withdrawal and suspension of the 

accreditation (or its acceptance of the 

accreditation) of a laboratory. 

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

defines a ‘‘third party conformity 

assessment body’’ to mean a conformity 

assessment body that is not owned, 

managed, or controlled by the 

manufacturer or private labeler of a 

product assessed by the laboratory, 

unless such a laboratory has satisfied 

certain statutory criteria. Section 

14(f)(2)(D) of the CPSA provides that a 

laboratory owned, managed, or 

controlled by a manufacturer or private 

labeler may be accredited 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. 

The final rule establishes the 

requirements for CPSC acceptance of the 

accreditation of a laboratory to test 

children’s products under section 14 of 

the CPSA. As discussed in detail in the 

preamble to the proposed rule, the 

requirements of the final rule are largely 

the same as the requirements used by 

the CPSC since passage of the CPSIA in 

August 2008. 77 FR at 31087–89. In 

addition, the rule delineates how a 

laboratory may discontinue voluntarily 


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Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 15837 

1An aliquot in chemistry is a portion of a sample. 

2HHXRF is an acronym for ‘‘handheld x-ray 

fluorescence spectrometry,’’ and it is used to 

distinguish this type of handheld device from other 

forms of XRF spectrometry. 

its participation with the CPSC, and it 

establishes the procedures for the 

suspension and/or withdrawal of CPSC 

acceptance of the accreditation of a 

laboratory. The final rule also amends 

the recent final rule titled, ‘‘Audit 

Requirements for Third Party 

Conformity Assessment Bodies’’ (audit 

final rule), which implements section 

14(i)(1) of the CPSA. Finally, the final 

rule makes particular conforming 

amendments to 16 CFR 1118.2(a). 

II. Comments on the Proposed Rule and 

the Commission’s Responses 

In this section, we describe and 

respond to the comments received on 

the proposed rule. A summary of each 

of the commenter’s topics is presented, 

and each topic is followed by our 

response. We received six comments on 

seven topics. Several commenters make 

general statements supporting the 

overall purpose of the proposed rule. 

All of the comments can be viewed at: 

www.regulations.gov, by searching 

under the docket number of the 

rulemaking, CPSC–2012–0026. 

A. Sample Homogeneity and X-Ray 

Fluorescence Spectrometry 

(Comment 1) With regard to the 

proposed test methods for determining 

lead content in component parts, a 

commenter notes the proposed 

requirement that three or more 

measurements must be made when 

using the x-ray fluorescence 

spectrometry (XRF or EDXRF) method 

described in ASTM F2853–10, also 

known as Energy Dispersive XRF 

Spectrometry Using Multiple 

Monochromatic Excitation Beams 

(currently allowed for lead in paint 

testing). As described in the proposed 

test method, the three measurements are 

intended to ensure some degree of 

spatial homogeneity or assurance that 

the material tested does not indicate 

falsely compliance with the lead content 

limit of 100 parts per million (ppm) 

because a ‘‘local’’ area, unrepresentative 

of the component part, was tested. The 

commenter recommends removal of the 

requirement to sample three or more 

areas using the lead content testing 

method described in ASTM F2853–10. 

The commenter states that any 

empirical evidence of nonhomogenieties 

resulting in a false determination of 

compliance is ‘‘questionable at best.’’ 

The commenter raises several objections 

to the ‘‘wet chemistry’’ method 

(Inductively Coupled Plasma, or ICP, 

using various spectrometric techniques), 

including a procedural step where 30 to 

100 milligrams (mg) of a sample are 

collected and subjected to testing. The 

commenter points out that the ICP 

method does not require samples from 

three areas of the component part to be 

tested, and the commenter questions 

why the XRF method should be subject 

to that requirement. The commenter 

opines that this is a policy issue to be 

determined by the Commission and not 

a technical issue to be determined by 

CPSC staff. The commenter states that if 

a component part ‘‘appears not to have 

visual anomalies, it can reasonably be 

presumed to in fact be homogeneous 

with respect to its lead content.’’ The 

commenter adds that very small 

component parts may pose practical 

difficulties in providing locations for 

three measurements and that the 

proposed testing method has no 

allowance for very small component 

part testing. The commenter concludes 

that the test method, ASTM F2853–10, 

requires only one measurement when 

used to determine the lead content of a 

paint sample. 

Another commenter expresses 

concern that the small spot size (on the 

order of 1 mm2) increases the sensitivity 

of the test method ASTM F2853–10 to 

nonhomogenieties in the lead content of 

the component part under test. 

Another commenter expresses 

concern that the testing for homogeneity 

requires the use of XRF in the test 

methods for lead content determination 

(the requirement that at least three 

spatially separated measurements be 

made). The commenter points out that 

the ICP method requires only 30 to 100 

mg of material, which the commenter 

considers ‘‘incongruous’’ with respect to 

homogeneity. 

Another commenter remarks that the 

CPSC test method CPSC–CH–E1001– 

08.2 (total lead (Pb) in nonmetal 

children’s products), states that a 

homogenized aliquot 1 should be 

prepared after grinding a sufficient 

sample of a component part for ICP 

testing. The commenter states that there 

is no clear guidance on how to 

determine what is ‘‘sufficient.’’ The 

commenter also notes that if a sample is 

not homogeneous, ICP testing is 

required (instead of XRF). However, the 

commenter asserts that if the component 

part is nonhomogeneous, the ICP testing 

results can vary, depending on where 

the sample is taken. The commenter 

opines that ICP testing of 

nonhomogeneous component parts may 

not adequately reflect the component 

part’s lead content, and XRF testing, 

using multiple locations, is better for 

determining the component part’s lead 

content. 

(Response 1) We decline to revise the 

test method for determining lead 

content that requires multiple sample 

areas to be tested when using forms of 

XRF. We believe that XRF has the 

potential, with certain limitations, to 

measure reliably lead content in some 

homogeneous metal and glass materials 

at the concentrations necessary to 

certify compliance with the 100 parts 

per million (ppm) limit now required 

under the CPSIA for children’s 

products. With the appropriate test 

methods and reference materials, CPSC 

staff considers homogeneous substrates 

to be necessary in order for the XRF 

methods included in ASTM F2853–10, 

or in the proposed CPSC test methods, 

to be effective in determining the 

compliance of the sample being tested. 

Multiple measurements are required to 

determine that such homogeneity exists, 

which allows the use of the XRF 

measurements for children’s product 

certification purposes. We agree that it 

is important to obtain a sufficient 

sample for wet chemistry testing. The 

CPSC wet chemistry test methods for 

determining lead in a substrate include 

instructions for the user to make every 

effort to homogenize the sample prior to 

taking 30 to 100 mg for testing. Thus, a 

sufficient sample would be an amount 

that ensures that the portion selected for 

testing actually represents the total lead 

content of the component part under 

evaluation. 

With respect to small parts and the 

need to determine homogeneity, there 

are no limitations on using XRF for 

testing small component parts. Small 

parts may be rotated so that different 

surface areas would be tested. If three 

completely distinct areas could not be 

tested, three separate tests could still be 

done on overlapping areas. 

(Comment 2) A commenter asserts 

that all XRF techniques are being 

subjected to additional homogeneity 

requirements that are really intended 

only for the ASTM F2853–10 method. 

The commenter asserts that the 

relatively large spot size of other XRF 

methods mitigates the need for the 

repeated measurements in the proposed 

test method. The commenter 

recommends that in order to mitigate 

some of the heterogeneity effect: 

* * * an 8 mm diameter x-ray surface shot 

(HHXRF),2 with a scatter that widens in three 

dimensions, should be as much of a 

heterogeneity correction as the 100 mg 

sample size for wet chemistry to be 

considered quantitative under EN 71–3 and 

others. 

The commenter adds that even though 

other types of XRF spectrometers that 


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15838 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 

do not meet the requirements of ASTM 

F2853–10 are far less vulnerable to 

nonhomogenieties in a test sample, a 

homogeneity test for XRF methods 

should be retained, rather than 

eliminated, ‘‘because the need to limit 

all EDXRF techniques to materials that 

are proven to be homogeneous is 

beyond question.’’ 

(Response 2) We decline to remove 

the requirement to test multiple areas of 

the component part for lead from the 

test method. We believe that for dense 

materials, like metals and glass, typical 

XRF instruments sample a very small 

mass of the sample because the 

penetration of the x-rays is limited. 

Thus, it is appropriate when testing 

dense materials, to measure multiple 

areas to ensure homogeneity when using 

these test methods as the basis for 

issuing a Children’s Product Certificate. 

(Comment 3) A commenter notes that 

in § 1112.15(b)(29) of the proposed rule, 

in order for a laboratory to have its 

accreditation accepted by the 

Commission to test for lead content in 

children’s metal products, a third party 

conformity assessment body must have 

the CPSC test method CPSC–CH– 

E1001–08, CPSC–CH–E1001–08.1, or 

CPSC–CH–E1001–08.2 in its statement 

of scope. The commenter further notes 

that in § 1112.15(b)(28) of the proposed 

rule, in order for a laboratory to have its 

accreditation accepted by the 

Commission to test for lead content in 

children’s metal jewelry, a third party 

conformity assessment body must have 

the CPSC test method CPSC–CH– 

E1001–08 or CPSC–CH–E1001–08.1 in 

its statement of scope. The commenter 

requests that the ‘‘-08.2’’ version of the 

test method be allowed to be used by a 

laboratory for the testing of lead in 

children’s metal jewelry, adding that 

this method allows the use of XRF 

testing. 

(Response 3) We agree with the 

commenter that CPSC test method 

CPSC–CH–E1001–08.2 should be 

allowed under § 1112.15(b)(28) of the 

final rule. In the proposed rule, test 

method CPSC–CH–E1001–08.2 

inadvertently was not included in 

proposed § 1112.15(b)(28), although it 

was intended that the test method be 

allowed. Therefore, in the final rule, 

§ 1112.15(b)(28) expressly allows use of 

test method CPSC–CH–E1001–08.2. 

(Comment 4) A commenter requests 

that a procedure for plated metals and 

glazed ceramics be developed for XRF 

using the ASTM F2853–10 method. This 

procedure would involve grinding a 

plated metal or glazed ceramic sample, 

as is done in preparation for an ICP test, 

and then testing the blended sample 

using the ASTM F2853–10 method. 

Another commenter requests that the 

CPSC make explicit that XRF can be 

used to test electroplated metals for lead 

content. The commenter notes that 

electroplating does not fall into the 

definition of a ‘‘paint or other similar 

surface-coating material’’ described in 

16 CFR 1303.2(b)(1). 

(Response 4) We disagree with the 

commenter’s request to develop a 

procedure using the ASTM F2853–10 

method for plated metals and ceramics 

because the method has not been 

validated for use on ground metals, 

which behave differently than solids 

when tested XRF, due to different 

scattering behavior and the presence of 

interstitial air gaps. Electroplated metals 

and glazed ceramics pose an especially 

difficult analysis challenge for XRF. 

Because such coatings become part of 

the substrate and are not subject to the 

lead paint ban, it is necessary to 

consider the single, nonhomogeneous 

material that results from the 

electroplating bonding with the 

substrate. The idea for a method 

suggested by the commenter could 

potentially be developed by some party 

in the future. We are particularly 

concerned that the small volume and 

mass of a sample probed by XRF would 

not adequately serve to indicate the 

homogeneity of the sample. 

We decline the request to allow XRF 

to be used to test electroplated materials 

because currently it is not possible to 

determine the correct lead content in 

such materials by this method. The 

commenter is correct that electroplated 

coatings that become part of the 

substrate are not considered paint under 

16 CFR part 1303. The combined 

electroplated metal (i.e., the 

electroplating and the substrate 

together) must meet the 100 ppm lead 

limit. The x-rays used in XRF penetrate 

only a very small distance through 

metals, and as such, tend to sample the 

outer surface to a much higher degree 

than the base metal (substrate). The 

limited depth of x-ray penetration 

means that electroplating can screen the 

base metal from being properly 

measured by XRF. Additionally, 

because the x-rays do penetrate 

somewhat into the base metal, such a 

measurement also is not suitable for 

determining the lead in the 

electroplated coating itself, although it 

is only the combination of the two that 

is required to meet the 100 ppm lead 

content limit. 

(Comment 5) A commenter questions 

the difference between the XRF method 

described in ASTM F2853–10 and other 

methods of XRF in their ability to detect 

lead in paint. Currently, only ICP 

techniques, or the XRF method 

described in ASTM F2853–10, are 

allowed to be used to determine the lead 

content in paint for children’s product 

certification purposes. The commenter 

asserts that improvements in detector 

technology have improved the 

performance of handheld XRF 

instruments. The commenter adds that 

work is under way to convert the 

traditional lead in paint measurement of 

‘‘Mass Loading,’’ or micrograms per 

cm2, into a concentration measurement 

of ppm. 

(Response 5) At present, no XRF 

method, other than ASTM F2853–10, is 

recognized by the CPSC to determine 

accurately the lead content of painted 

surfaces of consumer products. The lead 

paint ban in 16 CFR part 1303 is based 

on the definition of ‘‘lead paint’’ as 

paint containing in excess of 0.009 

percent lead by weight. Measurements 

in micrograms per cm2 cannot be used 

to make such a determination without 

knowing the density and thickness of 

the paint, neither of which is generally 

known at the time of testing. 

(Comment 6) A commenter states that 

other forms of XRF are at least as 

accurate as the ASTM F2853–10 

method, and they disagree with the use 

of the phrase ‘‘may be,’’ rather than the 

same language used for the ASTM 

F2853–10 method of describing suitable 

instruments for the accurate 

determination of lead in glass materials 

and homogeneous metals. 

(Response 6) The commenter is 

referring to Tab C in the Staff Briefing 

Package, Requirements Pertaining to 

Third Party Conformity Assessment 

Bodies, for the proposed rule. Tab C, 

titled, Study on the Applicability of Xray Fluorescence Spectrometry for 

Measuring Lead in Metal and Glass 

Substrate, describes how XRF 

potentially could be used to test 

homogeneous metal and glass materials 

found in children’s products. The report 

examines extending the use of XRF 

beyond the already-approved method 

for polymeric materials to include glass 

and metal substrates. 

At the time the report was prepared, 

the CPSC test methods for determining 

the lead content of metal and 

nonmetallic component parts did not 

include procedural steps or limitations 

on the use of XRF for homogeneous 

glass materials, crystals, and some 

metals. The report recommended 

updating the CPSC test methods to 

allow laboratories to use HHXRF or 

other types of laboratory XRF analyzers 

for testing glass and metal items, with 

limitations. 

Since then, the CPSC test methods 

have been updated. The phrase ‘‘may 

be’’ is not used in the context of XRF in 


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Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 15839 

either the proposed rule or the proposed 

CPSC test methods, other than stating: 

‘‘Destructive sample preparation 

techniques may be required for certain 

components to create a uniform sample 

for testing.’’ 

(Comment 7) A commenter states that 

the limitations applied to other forms of 

XRF listed in the test methods, CPSC– 

CH–E1001–08.2 and CPSC–CH–E1002– 

08.2, should apply to the form of XRF 

described in ASTM F2853–10. 

According to the commenter, the CPSC 

test methods apply only four limitations 

to the form of XRF described in ASTM 

F2853–10. The commenter recommends 

the following additional limitations be 

applied to the form of XRF described in 

ASTM F2853–10: 

• Verify the instrument performance 

daily, by analyzing one or more 

reference materials of the same matrix 

or metal type as the materials on which 

the analyses will be performed. 

• For testing metals, if the form of 

XRF described in ASTM F2853–10, 

deviates from the method described in 

the ASTM test method, all of the 

limitations in test method CPSC–CH– 

E1001–08.2 applied to other forms of 

XRF should be applied to the form of 

XRF described in ASTM F2853–10. 

• Because uncoated wood and fabrics 

were not evaluated in the 

interlaboratory study of the form of XRF 

described in ASTM F2853–10, all of the 

limitations in test method CPSC–CH– 

E1002–08.2 applied to other forms of 

XRF should be applied to the form of 

XRF described in ASTM F2853–10. 

(Response 7) With regard to the first 

bullet point in the commenter’s 

recommendations, we agree that it is 

important for reasonable quality 

assurance/quality control (QA/QC) 

requirements to be a part of all types of 

XRF testing. However, we found that 

section 13.3 of ASTM F2853–10 

provides guidance on quality control 

samples that should be followed to 

verify system control. The absence of an 

applicable existing standard for other 

XRF methods, and the wide variety of 

XRF instrumentation used in the more 

general case, led us to make the specific 

QA/QC directions discussed. We 

included in the lead test methods 

quality control guidelines described in 

section 6 of International 

Electrotechnical Commission (IEC) 

Method 62321 ED 1.0 B; but because 

that method is designed for higher lead 

concentrations, we added the 

requirement to verify XRF spectrometer 

performance daily by analyzing a 

reference material with 50 to 300 ppm 

lead content. 

The second and third bullet points in 

the commenter’s recommendations 

suggest that additional limitations 

should be placed on ASTM F2853–10 

testing for metals other than zinc. We 

believe that the staff study presented in 

Tab C of the Staff Briefing Package for 

the NPR was sufficient and that CPSC– 

CH–E1001–08.2 adequately deals with 

other metals for XRF testing using the 

method described in ASTM F2853–10. 

The third bullet point suggests that for 

natural wood and for fabric, ASTM 

F2853–10 testing should have the same 

requirements as traditional XRF testing, 

and CPSC staff believes that is the case 

as the method is written. 

(Comment 8) A commenter requests 

clarification on several technical issues 

related to XRF testing. 

First, the commenter asks if the term 

‘‘matrix’’ means ‘‘metal’’ or the specific 

alloy used as a reference material in the 

test method CPSC–CH–E1001–08.2. 

Second, the commenter asks for 

guidance on how many glass or other 

substrate standards should be used daily 

to verify instrument performance in the 

test method CPSC–CH–E1002–08.2. 

Finally, the commenter questions the 

value of a relative standard deviation 

(RSD) of 30 percent for very low 

instrument readings using the XRF 

method described in ASTM F2853–10. 

In the commenter’s opinion, this 

proposed requirement does not take 

instrument repeatability into account 

and makes more expensive ICP testing 

necessary, even though the readings are 

not close to the compliance limits. The 

commenter recommends that when the 

testing results are well below the 

concentration limit that would render a 

reading inconclusive, the XRF results 

should not be excluded from indicating 

compliance with the lead content limit. 

(Response 8) With regard to the 

commenter’s first and second questions, 

it is not possible to know the exact alloy 

that is to be tested or to have sample 

standards that exactly match its 

chemical composition. Thus, ‘‘matrix’’ 

is used as a generic term to include 

metals and alloys similar to the sample 

to be tested. Laboratories should 

develop QA/QC procedures, including 

having various relevant metals, glass, 

and plastic standards to verify 

instrument performance. Exactly how 

extensive such a collection must be 

should be left up to the individual 

laboratories, their accreditation bodies, 

and their customers. 

We agree with the commenter’s final 

comment. Notably, this comment 

illustrates that at very low lead 

concentrations, differences of just a few 

ppm in measurements can result in an 

RSD indicating nonhomogeneity where 

possibly the instrumental variability is 

dominating the calculation. We believe 

that it is appropriate to allow XRF use 

where at least three measurements were 

taken by XRF as described in this 

method, and the result of each of those 

measurements is below 50 percent of 

the limit (i.e., below 50 ppm), subject to 

the remaining limitations given for all 

types of XRF. Staff has posted two new 

test methods, CPSC–CH–E1001–08.3 

(http://www.cpsc.gov/PageFiles/137829/ 

CPSC-CH-E1001-08_3.pdf) and CPSC– 

CH–E1002–08.3 (http://www.cpsc.gov/ 

PageFiles/137832/CPSC-CH-E1002- 

08_3.pdf) on the CPSC Web site, which 

includes this change, and the final rule 

allows this as an option for laboratory 

accreditation. 

(Comment 9) One commenter refers to 

the requirement in Public Law 112–28 

for the CPSC to provide alternative 

testing requirements for small batch 

manufacturers for testing compliance 

with some product safety rules and to 

exempt small batch manufacturers from 

the third party testing requirements if 

no alternative testing requirement is 

available or economically practicable. 

The commenter proposes that the 

Commission allow handheld XRF, 

which the commenter notes, the 

Commission recognizes is less 

expensive than other approved test 

methods. The commenter suggests that 

the Commission allow it to be used for 

third party testing of other substrates, in 

addition to the homogenous polymer 

substrates for which it has already been 

approved. The commenter is willing ‘‘to 

work with the Commission ‘‘on the 

execution of a plan that will prevent the 

needless exemption of an entire subset 

of the market that we all agree is in need 

of this regulatory oversight.’’ 

(Response 9) The CPSC has proposed 

the use of XRF to determine the lead 

content of glass materials, crystals, and 

some metals. At this time, we are not 

recommending that handheld XRF be 

approved for the third party testing of 

other substrates. CPSC staff has not 

determined that handheld XRF 

possesses enough accuracy, precision, 

and repeatability required for the 

determination of the lead content of 

substrates other than in homogenous 

polymer products and the proposed 

materials. 

Public Law 112–28 requires the 

Commission to provide alternative 

testing requirements for small batch 

manufacturers for certain children’s 

product safety rules. If no alternative 

method is available, the Commission, 

with some exceptions, is to exempt 

small batch manufacturers from the 

third party testing requirements. 

However, developing alternative testing 

requirements for small batch 

manufacturers is not within the scope of 


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the current rulemaking proceeding, 

which concerns the accreditation 

requirements for third party conformity 

assessment bodies. 

(Comment 10) A commenter asks that 

the CPSC propose a technical, rather 

than a proprietary solution, for lead 

content testing. The commenter asserts 

that the CPSC must allow new and 

emerging technologies the same access 

to the proposed test methods. 

(Response 10) The CPSC does not 

endorse one product or technique over 

another, equally effective product or 

technique. For lead content testing, 

multiple methods and technologies are 

available for use by a laboratory. Each 

acceptable method has been proven to 

meet the technical requirements (e.g., 

precision, accuracy, repeatability) 

needed to determine compliance to the 

lead content limit of 100 ppm. The 

CPSC supports the development of new 

technologies for achieving the goals of 

improved product safety and reduced 

costs to manufacturers. We decline to 

change the final rule based on this 

comment. 

B. Laboratory Accreditation 

(Comment 11) A commenter 

emphasizes the importance of the 

CPSC’s evaluation of the integrity of 

each laboratory’s independence and its 

compliance with the requirements of 

International Standards Organization/ 

International Electrotechnical 

Commission (ISO/IEC) 17025(E). The 

commenter states: 

By making the accreditation and audit 

requirements more focused on the 

authentication of independence, the CPSC 

will be able to adopt requirements that will 

further its commitment to ensure that all 

approved laboratories are meeting the 

conditions for their continuing accreditation. 

(Response 11) It is unnecessary to 

change the final rule based on this 

comment because the rule already 

addresses the commenter’s concerns. 

We agree that a laboratory’s 

independence should be reassessed on a 

regular basis. The final rule on the audit 

of third party conformity assessment 

bodies (16 CFR part 1112, subpart C) 

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. 

For the Commission to accept a 

laboratory as firewalled, the laboratory 

must have policies and procedures in 

place, consistent with laboratory 

independence and impartiality. To 

evaluate whether a laboratory satisfies 

these criteria on independence and 

impartiality, the final rule requires that 

a laboratory seeking CPSC-accepted 

firewalled status submit copies of 

various documents to the CPSC. The 

applicant 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 CPSC’s purpose in 

reviewing such documents would be to 

assess whether the laboratory has 

established the necessary written 

procedures to maintain its 

independence from the manufacturer or 

private labeler. We also 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 and 

explaining that an allegation of undue 

influence may be reported 

confidentially to the CPSC. Our purpose 

in 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 to exert undue influence. 

(Comment 12) A commenter 

recommends that reciprocity provisions 

be built into the accreditation and audit 

provisions for laboratories. The 

commenter asserts that in the absence of 

aligned standards and compliance 

protocols, accreditation for foreign 

laboratories from countries with 

reciprocity provisions is the optimum 

approach to third party testing and 

provides a ‘‘level playing field’’ for 

manufacturers and laboratories without 

compromising the accreditation 

program’s integrity. The commenter 

adds that for trade purposes, U.S.-based 

laboratories should be allowed to 

provide their services in any market that 

contains foreign-based laboratories 

seeking CPSC acceptance of their 

accreditation. 

The commenter adds that the 

Occupational Safety and Health 

Administration (OSHA) Nationally 

Recognized Laboratories (NTRL) 

program and the Federal 

Communications Commission (FCC) 

accreditation program for 

Telecommunications Certification 

Bodies include reciprocity provisions. 

The commenter states that such 

reciprocity provisions benefit U.S. 

manufacturers, by streamlining 

compliance requirements across markets 

and allowing laboratories to bundle 

services. 

(Response 12) We decline to adopt 

reciprocity as a criterion in the CPSC 

third party conformity assessment body. 

In implementing the CPSIA’s 

requirement that products subject to 

CPSC children’s product safety rules be 

third party tested, the CPSC’s interest is 

to establish an effective and efficient 

program through which we recognize 

laboratories worldwide that are 

competent to conduct these third party 

tests. The use of International 

Laboratory Accreditation Cooperation— 

Mutual Recognition Arrangement 

(ILAC–MRA) signatory accreditation 

bodies creates a level playing field, by 

providing an internationally available, 

consistent, accreditation process for 

laboratories, regardless of where they 

are located. Any CPSC-accepted 

laboratory, whose scope includes the 

tests conducted, may test children’s 

products for compliance to the 

applicable CPSC children’s product 

safety rules. Reciprocity provisions 

regarding U.S.-based laboratory 

activities in other nations are not 

necessary to ensure the technical 

competence and objective assessment of 

compliance from a CPSC-accepted 

laboratory. 

(Comment 13) Two commenters note 

that the proposed rule defines a 

‘‘firewalled’’ laboratory, in part, as one 

that ‘‘is under a contract to a 

manufacturer or private labeler * * * 

that explicitly limits the services [it] 

may provide for other customers and/or 

limits which or how many other entities 

may also be customers of the 

[laboratory].’’ (Proposed § 1112.11(b) 

(1)(ii)(D)). The commenters assert that 

the definition constitutes an 

unnecessary and unwarranted intrusion 

into the private contractual rights of 

independent laboratories and their 

customers. 

One commenter notes that absent any 

indication that such a contractual 

relationship, in fact, constitutes 

‘‘ownership or control’’ by a 

manufacturer over a laboratory, the 

proposed rule/staff justification offers 

no foundation for this provision, and in 

fact, appears to have no valid purpose 

(including any based on congressional 

intent in this regard) for such an overly 

broad definition of ‘‘firewalled lab.’’ 

Another commenter recommends that 

this provision be modified to reflect 

that, absent any indication that such a 

contractual relationship, in fact, 

constitutes ‘‘ownership or control’’ by a 

manufacturer over a laboratory, the 

laboratory should not be considered to 

be a ‘‘firewalled lab.’’ 

(Response 13) The preamble to the 

proposed rule included a discussion 

noting that a contractual relationship 

between a manufacturer and a 

laboratory that explicitly limits which 

or how many other entities may also be 

customers of the laboratory would grant 


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the manufacturer such a significant 

interest in the work of the laboratory 

that the Commission would consider the 

interest ‘‘controlling.’’ Section 

1112.11(b)(1)(ii)(D) of the proposed rule 

would designate a laboratory with such 

a contractual relationship with a 

manufacturer as ‘‘firewalled.’’ 

After reviewing the comments 

regarding this section of the proposed 

rule, we agree with the commenters that 

this type of contractual relationship 

would not necessarily result in a 

situation where the manufacturer 

controls the laboratory. Because the 

specific details of these types of 

contracts are highly variable, it would 

be impractical and complex to assess 

independently each contract on a caseby-case basis. Further, we consider that 

such an assessment would result in 

little benefit to consumer safety, above 

the other elements in the rule that 

define a firewalled laboratory, and 

above the criteria CPSC acceptance of a 

laboratory’s accreditation. Therefore, we 

are removing the provision regarding 

contractual relationships as one of the 

criteria that define a ‘‘firewalled’’ 

laboratory in § 1112.11(b)(1)(ii)(D) of the 

final rule. 

(Comment 14) One commenter 

recommends that the provision stating 

that a ‘‘one percent or greater ownership 

or control’’ for a governmental 

laboratory (proposed § 1112.11(c)(1)), 

should instead be a higher percentage 

and/or a fact-based determination based 

on the ‘‘undue influence’’ definition 

whereby the governmental ownership or 

control causes the laboratory to 

‘‘compromise the integrity of its testing 

processes or results.’’ 

(Response 14) We decline to select 

another percentage for governmental 

ownership or control based on this 

comment. Section 14(f)(2)(B) of the 

CPSA states that a governmental third 

party conformity assessment body is an 

entity that is owned or controlled in 

whole or in part by a government. ‘‘In 

part’’ can be interpreted to be any 

proportion of ownership or control, and 

therefore, it is not limited to a minimum 

value. As stated in the proposed rule: 

‘‘Selecting one percent as an ownership 

threshold is a practical matter of 

selecting the smallest whole number as 

an expression of ownership.’’ The 

commenter does not provide a 

recommended value greater than one 

percent to indicate governmental 

ownership or control. Nor does the 

commenter provide a rationale for using 

an ownership percentage other than one 

percent. 

We decline to adopt the commenter’s 

recommendation with regard to 

considering a fact-based determination. 

The definition of a ‘‘governmental third 

party conformity assessment body’’ in 

section 14(f)(2)(B)(ii) of the CPSA states 

that the laboratory’s test results are not 

‘‘subject to undue influence.’’ We 

interpret ‘‘subject to undue influence’’ 

to mean being liable or vulnerable to 

undue influence, not to an after-the-fact 

determination that undue influence had 

actually been exerted to compromise the 

integrity of testing results. Thus, we 

consider being vulnerable to the 

exercise of undue influence, not 

whether the undue influence has 

occurred, as being ‘‘subject to undue 

influence.’’ 

(Comment 15) One commenter 

recommends eliminating the provision 

that a laboratory will be classified as 

‘‘governmental’’ if any of that 

laboratory’s ‘‘management or technical 

personnel include any government 

employees.’’ (Proposed § 1112.11(c)(4)). 

The commenter asks whether the phrase 

‘‘technical personnel’’ should be deleted 

or clarified to indicate that such 

individuals cannot be employees of both 

the government and the laboratory, or 

whether another modification should be 

provided because some government 

employees might be assigned 

temporarily to a laboratory for specific 

training/oversight/similar legitimate 

function. 

(Response 15) We decline the 

commenter’s recommendation. We 

assume that a government management 

or technical employee is present in the 

laboratory to perform a function 

essential to the laboratory’s testing 

operations. If the management or 

technical position is controlled by the 

government, then the government has 

control over some aspect of the 

laboratory’s testing and test results. 

Therefore, additional safeguards against 

the exercise of undue influence are 

warranted. 

(Comment 16) One commenter 

recommends that the Commission 

modify proposed § 1112.43 to clarify 

that only ‘‘material’’ omissions or 

‘‘materially incorrect’’ information in an 

application for acceptance can be 

grounds for denial of the application 

and that the laboratory is to be afforded 

a reasonable opportunity to correct an 

omission or error in its application. 

(Response 16) We decline the 

commenter’s recommendation to change 

the proposed rule because all of the 

information described as grounds for 

denial of an application in § 1112.43 of 

the rule is considered material. If any of 

the information described in 

§ 1112.43(a) is not provided, that would 

be considered to be a material omission. 

Any inaccurate information would be 

considered materially incorrect. 

Clarification in this section is not 

necessary because the plain language of 

§ 1112.43(a) of the rule includes the 

omissions of information considered to 

be material. 

We do not agree with the commenter 

that changes are needed to the proposed 

rule to provide an applicant a 

reasonable opportunity to correct an 

omission or error in its application 

because the language in the proposed 

rule already provides such opportunity. 

Section 1112.17(a) of the final rule 

(unchanged from the proposal) allows 

CPSC staff to contact a laboratory with 

any questions regarding an application 

or to request the submission of missing 

information. Section 1112.43(b) in the 

final rule provides that ‘‘the CPSC’s 

denial of an application will follow the 

process described in § 1112.51 of this 

subpart.’’ Section 1112.51 of the final 

rule stipulates that the CPSC will 

provide an initial notice that advises the 

laboratory of the specific grounds for a 

denial of an application. Some common 

reasons for denial of an application 

include: a missing scope document or a 

missing or incorrect test method 

reference within a scope document. 

In § 1143(a)(1) of the final rule, a 

laboratory has 30 calendar days to 

respond and correct the issue. Further, 

the procedures in the final rule allow for 

a laboratory to request an extension of 

time with an explanation and an 

estimate for how much additional time 

is needed. Even in cases in which an 

applicant cannot correct the issue 

within an allotted extension and an 

application is denied, the applicant may 

reapply for CPSC acceptance when all 

required elements are fulfilled. 

(Comment 17) One commenter 

recommends that the Commission 

specify that only a ‘‘material’’ failure ‘‘to 

comply with an applicable [test method] 

protocol, standard or requirement 

* * *’’ (proposed § 1112.47(b)) or a 

‘‘material’’ failure ‘‘to comply with any 

provision of Subpart B’’ (1112.47(c)) 

may provide grounds for CPSC 

withdrawal of a laboratory’s 

accreditation, not just any minor/ 

technical failure, which the commenter 

asserts the proposed rule now seems to 

allow. 

(Response 17) We decline the 

commenter’s recommendation to add 

the additional language in section 

1112.47(b) or (c) of the final rule 

because the plain language of those 

sections, as proposed, already addresses 

the commenter’s concerns. Any failure 

‘‘to comply with an applicable protocol, 

standard, or requirement * * *’’ is 

grounds for withdrawal of CPSC 

acceptance listed in § 1112.47(b) of the 

proposed rule (unchanged in the final 


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rule), because the applicable protocol, 

standard, or requirement is considered 

to be ‘‘material’’ or it would not have 

been included in the rule. Similarly, any 

failure ‘‘to comply with any provision of 

Subpart B’’ in § 1112.47(c) of the final 

rule may be grounds for withdrawal of 

CPSC acceptance because those 

requirements would not be included in 

the rule unless they were considered 

‘‘material.’’ 

(Comment 18) A commenter 

recommends that § 1112.53 of the 

proposed rule should specify in more 

detail the circumstances under which 

the CPSC may immediately suspend its 

acceptance of a laboratory’s 

accreditation. 

(Response 18) We disagree that the 

changes suggested by the commenter are 

needed in this section of the proposed 

rule because the proposed rule at 

§ 1112.53 already clearly describes, in 

detail, the circumstances under which 

the CPSC may withdraw immediately 

and temporarily its acceptance of a 

laboratory’s accreditation. The CPSC 

may take such action when it is in the 

public interest to protect health and 

safety. The section defines ‘‘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 has 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. 

We believe this language, which is 

unchanged from the proposal, clearly 

defines the threshold for CPSC to 

consider immediate withdrawal of its 

acceptance of accreditation. 

(Comment 19) A commenter requests 

that the status of CPSC-accepted 

laboratories be disclosed publicly and 

that it should be readily ascertainable 

on the CPSC’s Web site. 

The list of CPSC-accepted laboratories 

on the CPSC Web site at: http:// 

www.cpsc.gov/en/BusinessManufacturing/Lab-Accreditation/, 

currently does not display whether a 

laboratory is categorized as 

independent, firewalled, or 

governmental. The commenter asserts 

that it is in the interest of commercial 

customers and consumers to display 

this information and that the proposed 

rule should be modified to require that 

in applying for acceptance by the CPSC, 

‘‘a lab must accede to the public 

disclosure of its acceptance status’’ 

(independent, firewalled, governmental) 

on the Web site display of CPSCaccepted laboratories. 

(Response 19) For the reasons stated 

by the commenter we agree to list the 

independent, firewalled, or 

governmental status of accepted 

laboratories on the CPSC Web site at 

section 1112.19. While it is true that 

once its accreditation is accepted by the 

CPSC, a laboratory may conduct tests 

within its scope for children’s product 

certification purposes, regardless of its 

status as an independent, governmental, 

or firewalled laboratory there is no 

restriction on the CPSC providing the 

public and manufacturers with this 

information. 

It is important to note, however, that 

many of the CPSC-accepted 

governmental laboratories have a small 

portion of government ownership and 

little-to-no government involvement in 

their operations. These laboratories 

operate essentially as independent 

laboratories, but by law, they must be 

categorized as ‘‘governmental’’ because 

they have partial government 

ownership, such as through a joint 

venture. Other governmental 

laboratories are associated with statefunded institutions. Because forms of 

governmental involvement can vary, 

listing a laboratory as ‘‘governmental’’ 

does not necessarily convey any 

meaningful information to the public. 

Yet, in the interest of transparency the 

Commission has chosen to provide the 

information in a similar manner to the 

way in which the CPSC lists firewalled 

laboratories. 

As noted, the CPSC already lists 

firewalled laboratories on its Web site, 

despite the fact that the firewalled status 

applies only to a manufacturer or 

private labeler who owns, manages, or 

controls the laboratory. This practice 

will not change. (See http:// 

www.cpsc.gov/en/Business— 

Manufacturing/Lab-Accreditation/.) In 

other words, the laboratory is 

considered independent for any other 

manufacturer or private labeler who 

may wish to use the laboratory’s 

services. 

C. Inspections and Investigations 

(Comment 20) One commenter 

recommends modifying proposed 

§ 1112.27 to clarify that laboratories 

must allow on-site inspections by CPSC 

personnel or their designated 

representative, without exception. The 

commenter notes that this should be 

enforced uniformly, to allow 

participation in the program. 

(Response 20) We do not believe that 

the requested modification is necessary. 

The language in proposed § 1112.27 

states: ‘‘A third party conformity 

assessment body, as a condition of its 

accreditation, must allow an officer or 

employee duly designated by CPSC to 

enter and inspect the third party 

conformity assessment body for 

purposes of an investigation under this 

part.’’ (emphasis added). The language 

in proposed § 1112.27 (unchanged in 

the final rule) is clear regarding the 

compulsory nature of allowing on-site 

inspections when asked by CPSC 

personnel for the purpose of an 

investigation as a condition of accepting 

the laboratory’s accreditation. 

(Comment 21) Two commenters 

request that ‘‘failure to cooperate’’ 

should be defined to address 

specifically only the actions or inactions 

that are within the scope of an 

investigation, and they should not be 

defined in regard to any other request 

from CPSC staff. The commenters opine 

that ‘‘a request to receive a subpoena for 

requested documents or the assertion of 

any other legal rights or procedures 

available to the lab in question should 

explicitly not be considered ‘failure to 

cooperate.’’’ 

(Response 21) Because both the CPSA 

and the final rule specifically state that 

accreditation may be suspended for 

failing to cooperate with an 

investigation, we believe that the 

current text of the final rule already 

meets the commenters’ request to limit 

the suspension to the scope of the 

investigation. 

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

The Commission may suspend the 

accreditation of a conformity assessment 

body if it fails to cooperate with the 

Commission in an investigation under this 

section. 

Section § 1112.45 of the final rule: 

What Are the Grounds for Suspension of 

CPSC Acceptance? implements section 

14(e)(3) of the CPSA by stating: 

(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. 

Finally, a laboratory that exercises 

any legal procedural right available 

under law would not be considered to 

have ‘‘failed to cooperate’’ under the 

final rule. Such a legal procedural right 

would include a laboratory request for 

the issuance of a subpoena before 

providing documents to the CPSC. 

(Comment 22) One commenter states 

that the suspension of acceptance of 

accreditation of a laboratory should be 


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warranted only when a laboratory 

exhibits a pattern of evading legitimate 

CPSC requests or inquiries related to an 

inspection or investigation. This 

commenter states that a ‘‘failure to 

cooperate’’ should specifically exclude: 

‘‘reasonable delays in providing 

requested information or documents, 

considering all the circumstances.’’ The 

commenter asks that the phrase ‘‘failure 

to respond to CPSC inquiries or 

requests’’ (section 1112.45(a) of the 

proposed rule) be defined more 

specifically to specify, for example, a 

20-day period or other reasonable time, 

based on the circumstances. 

(Response 22) We decline to adopt the 

commenter’s recommendations. We 

agree with the commenter that evasive 

responses to CPSC inquiries could be 

grounds for suspension of the CPSC’s 

acceptance of the laboratory’s 

accreditation. Section 1112.45 of the 

final rule states: 

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. 

Because the text of the proposed and 

final rule already includes responding 

evasively to investigations, we believe 

that the current text already meets the 

commenter’s concerns. It is not 

necessary for a pattern of evasion to be 

established before suspension of 

acceptance of accreditation is 

considered. Requiring a pattern of 

evasion would allow laboratories to 

respond to inquiries in a manner that is 

evasive some of the time, until a pattern 

is established. Because inspections or 

investigations frequently pertain to the 

presence of noncompliant children’s 

products in the marketplace, evasive 

responses are never acceptable. 

With regard to the commenter’s 

statement regarding ‘‘reasonable 

delays,’’ what is considered 

‘‘reasonable’’ varies, based on the nature 

of the request. Therefore, specifying a 

period is impractical. For example, a 

request for a corrected phone number, 

compared to a request for testing records 

covering a multiyear period, will have 

different ‘‘reasonable’’ expected 

response periods. Thus, 20 days may be 

excessive for a telephone number 

correction, while that period may be 

unreasonably short for the collection 

and transmission of voluminous 

records. Further, the phrase ‘‘other 

reasonable time based on the 

circumstances’’ does not add specificity 

to what is considered ‘‘reasonable.’’ 

(Comment 23) Two commenters state 

that a request by the CPSC for a 

laboratory’s ‘‘protocols and procedures’’ 

should relate only to the specific 

grounds for the investigation, not to 

testing in general. 

(Response 23) We decline the 

commenters’ request because the rule, 

as proposed, already addresses the 

commenters’ concerns. Section 

1112.25(a)(4) of the proposed rule: What 

are a third party conformity assessment 

body’s recordkeeping responsibilities? 

requires laboratories to maintain 

internal documents describing testing 

‘‘protocols and procedures’’ that have 

applied to a test conducted for purposes 

of section 14 of the CPSA. Section 

1112.51 of the rule, as proposed 

(unchanged in the final rule), limits 

investigations to applications for 

acceptance of accreditation, 

submissions alleging grounds for an 

adverse action, or other information 

received by the CPSC that relates to a 

third party conformity assessment 

body’s ability to become or remain 

CPSC-accepted. 

(Comment 24) Two commenters 

recommend that the term 

‘‘Investigation’’ be defined to mean 

more than a nonspecific request for 

information, with one commenter 

proposing a definition of 

‘‘Investigation’’ as a ‘‘formal inquiry 

based on specific and sufficient facts 

that give rise to a reasonable belief by 

the CPSC that a material violation of 

this rule has occurred.’’ This commenter 

then suggests that ‘‘Investigations’’ 

should be limited to the scope and the 

specific, material violation implicated 

by those facts. The commenter adds that 

‘‘Investigations’’ ‘‘should only be 

allowed when something akin to 

‘‘probable cause’’ arises about a specific 

violation of a lab and should not be 

allowed to be fishing expeditions by the 

agency.’’ 

(Response 24) We decline to add a 

formal pleading requirement or the 

equivalent of a ‘‘probable cause’’ 

requirement because determining 

whether an investigation is warranted is 

a fact-based judgment best made on a 

case-by-case basis. 

Section 1112.49(a) of the final rule 

(unchanged from the proposal) allows 

any person to submit information 

alleging grounds for adverse action, as 

set forth in part 1112. The submitter is 

required to allege that one or more of 

the grounds for adverse action set forth 

in part 1112 exist. Section 1112.49(a) of 

the final rule describes the kind of 

information necessary for CPSC to 

substantiate an allegation for an adverse 

action. Any investigation resulting from 

the information submitted under 

§ 1112.49 would be investigated under 

the procedures described in § 1112.51. If 

a person submitting information does 

not provide sufficient information to 

investigate an allegation, it will be 

difficult for the agency to substantiate 

the allegation, as is indicated in 

§ 1112.49(b), which states: 

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 the categories of 

information outlined in paragraph (a) of this 

section above. 

The language of § 1112.49(a) sets the 

threshold regarding the types and 

sufficiency of the information necessary 

to warrant an investigation. Therefore, it 

is unnecessary to define the term 

‘‘Investigation,’’ as the commenters have 

requested. 

D. Undue Influence 

(Comment 25) One commenter 

recommends that the Commission 

specify that the exercise of ‘‘undue 

influence’’ over the laboratory sufficient 

to justify CPSC ‘‘withdrawal’’ of its 

acceptance of the laboratory (proposed 

§ 1112.47(a)) must be ‘‘directly related 

and material to the scope of the testing 

for which the laboratory was accepted 

by the CPSC.’’ The commenter notes 

that this is particularly important 

regarding the requirements for 

‘‘firewalled’’ laboratories. 

(Response 25) We decline to adopt the 

commenter’s recommendation. The 

current language of §§ 1112.47(a) and 

1112.51 of the final rule (unchanged 

from the proposal) permits the CPSC 

flexibility in assessing the nature of 

various undue influences acting upon 

conformity assessment bodies, whereas 

the commenter’s recommendation 

would narrow this flexibility. This 

could have unintentional and 

unforeseeable consequences affecting 

the CPSC’s ability to address instances 

of undue influence for testing under the 

jurisdiction of the CPSC. 

The commenter does not explain why 

the withdrawal of CPSC acceptance of a 

firewalled laboratory should be treated 

differently than other types of 

laboratories. The CPSC regards any 

exercise of undue influence on the 

integrity of a laboratory’s test results as 

calling into question the integrity of all 

of the laboratory’s test results, including 

those related to the testing of children’s 

products. 

If a laboratory disagrees with a CPSC 

final notice of adverse action, § 1112.51 

of the final rule describes procedures for 

filing an administrative appeal. In 

addition, for firewalled laboratories, any 

suspension or withdrawal of CPSC 

acceptance of accreditation must be 


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done by order of the Commission. These 

procedures allow a laboratory to present 

its case, if there is disagreement with 

the CPSC staff findings that support an 

adverse action. 

E. Adverse Actions 

(Comment 26) One commenter 

recommends that the Commission 

clarify in the rule that, except for 

situations that warrant an ‘‘immediate 

suspension’’ of a laboratory, a laboratory 

may be suspended or withdrawn from 

acceptance only after a formal 

‘‘investigation’’ and an adequate 

opportunity for the laboratory to 

respond under the rule. 

The commenter further recommends 

that the Commission should allow 

‘‘immediate withdrawal’’ of a 

laboratory’s acceptance of accreditation 

(proposed § 1112.53) only upon an 

affirmative vote of the Commission (not 

a mere staff determination that 

withdrawal is necessary ‘‘to protect the 

public health and safety’’). The 

commenter notes that Commission 

action is necessary for the analogous 

action by the CPSC to waive the 6(b) 

notification rights of a company to 

disclose immediately product-specific 

information to the public, and likewise, 

should be required here. 

(Response 26) We decline the 

commenter’s recommendation for 

allowing for an ‘‘immediate suspension’’ 

because the final rule, which is 

unchanged from the proposed rule, 

already includes a section describing 

the procedures to be used during an 

investigation, and further clarification is 

not necessary. 

Subpart D of the final rule (unchanged 

from the proposal), Adverse Actions: 

Types, Grounds, Allegations, Procedural 

Requirements, and Publication, 

includes § 1112.51, What are the 

procedures relevant to adverse actions? 

describes the procedures that will be 

used to conduct an investigation, and it 

also includes established procedures 

and opportunities for the laboratory to 

respond. 

We decline to adopt the commenter’s 

recommendation that an affirmative 

vote of the Commission be required for 

‘‘immediate withdrawal’’ of a 

laboratory’s acceptance of accreditation. 

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

that accreditation of third party 

conformity assessment bodies may be 

conducted by the Commission or an 

independent accreditation organization 

designated by the Commission. 

Currently, CPSC staff has been tasked 

with reviewing and accepting the 

accreditation of independent and 

governmental laboratories. While CPSC 

staff also reviews accreditation and 

application materials from firewalled 

applicants, section 14(f)(2)(D) of the 

CPSA provides that the Commission 

may accept a firewalled laboratory’s 

accreditation by order of the 

Commission after determining that the 

firewalled applicant meets statutory 

requirements. 

Section 14(e) of the CPSA authorizes 

the Commission to withdraw or suspend 

its accreditation or acceptance of 

accreditation of a laboratory under 

certain conditions. To parallel the 

acceptance process to accredit 

firewalled laboratories, the withdrawal 

of acceptance of accreditation of 

firewalled laboratories occurs by 

Commission vote. In order to maintain 

the parallel structure of Commission 

acceptance of accreditation, the 

Commission does not require a vote to 

withdraw or suspend acceptance of 

accreditation of independent or 

governmental laboratories. 

F. Recordkeeping 

(Comment 27) One commenter 

suggests modifying the document 

retention requirement of proposed 

§ 1112.25(a) (1) to specify that only ‘‘test 

reports and technical records that are 

directly related and material to the 

scope of the laboratory’s acceptance 

related to that testing’’ must be retained 

under the rule. 

(Response 27) The proposed rule 

requires third party conformity 

assessment bodies to keep ‘‘test reports 

and technical records related to tests 

conducted for purposes of section 14 of 

the CPSA’’ (emphasis added). The 

commenter does not provide any 

information regarding the advantage of 

limiting the retention to those records 

that are ‘‘directly related and material’’ 

to the laboratory’s testing for purposes 

of section 14 of the CPSA. Moreover, we 

are not sure that the suggested change 

would make a difference in the records 

that conformity assessment bodies 

would be required to keep. Therefore, 

we decline to make the commenter’s 

recommended change. 

(Comment 28) One commenter 

suggests modifying proposed 

§ 1112.25(a) (2) to require only that the 

subcontractor laboratory’s test report be 

‘‘available with the prime contractor 

laboratory’s test report’’ and not 

necessarily ‘‘appended to’’ it. 

(Response 28) We agree with the 

commenter and will revise § 1112.25(a) 

(2) of the final rule to require making 

the subcontractor’s laboratory test report 

available to the CPSC upon request, but 

not necessarily appended to the prime 

contractor’s test report. We note that 

appending a subcontractor’s test report 

would satisfy the requirement to make 

the report available. 

(Comment 29) One commenter 

recommends modifying proposed 

§ 1112.25(b) to require that documents 

required to be retained be provided to 

the CPSC, upon request, within ‘‘48 

hours or within a reasonable time given 

the particular circumstances.’’ The 

commenter also asserts that we should 

require only that English translations of 

documents be supplied to the CPSC 

‘‘that are relevant and reasonably 

necessary with regard to the CPSC’s 

specific inquiry or investigation.’’ 

(Response 29) We decline to make the 

commenter’s recommended change to 

§ 1112.25(b) regarding changing ‘‘48 

hours’’ to ‘‘48 hours or within a 

reasonable time given the particular 

circumstances’’ when records are 

requested by the CPSC. However, we are 

revising § 1112.25(b) of the final rule to 

remove the ‘‘within 48 hours’’ language 

in the proposed rule and replace it with 

‘‘such as through an Internet Web site.’’ 

The revised language is consistent with 

the recordkeeping language in 16 CFR 

part 1107 (testing and labeling rule) and 

16 CFR part 1109 (component part 

testing rule), which require submission 

of records upon request, but do not 

specify a time frame within which the 

records must be submitted and allow for 

submittal of electronic records ‘‘such as 

through an Internet Web site.’’ Implicit 

in the requirement to submit records to 

the CPSC upon request is the 

commenter’s concept of ‘‘within a 

reasonable time given the particular 

circumstances.’’ The time frame 

necessary to respond to a document 

request by the CPSC, by its nature, must 

be determined on a case-by-case basis. 

Therefore, stating an explicit time 

frame, such as ‘‘48 hours,’’ as the 

proposed rule specified, would not fit 

the many different circumstances that 

might occur when the CPSC requests 

records. 

Regarding the commenter’s suggestion 

that we should only require English 

translations of documents ‘‘that are 

relevant and reasonably necessary with 

regard to the CPSC’s specific inquiry or 

investigation,’’ the documents required 

in §§ 1112.25(a)(1)-(4) of the final rule 

are always considered to be ‘‘relevant 

and reasonably necessary with regard to 

the CPSC’s specific inquiry or 

investigation.’’ Hence, that is the reason 

for the requirement to maintain those 

records. Therefore, we decline to make 

the commenter’s recommended change 

because the proposed and final rules 

inherently require maintaining records 

‘‘that are relevant and reasonably 

necessary with regard to the CPSC’s 

specific inquiry or investigation.’’ 


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(Comment 30) One commenter 

recommends that we modify the 

proposed rule to clarify generally that 

‘‘except for the status of an accepted 

laboratory, confidential business 

information, copyrighted information 

and trademarks, trade secrets and other 

information and documents provided to 

the CPSC by a laboratory under this rule 

is strictly protected from any third party 

disclosure under the all applicable laws, 

including, without limitation, the 

Consumer Product Safety Act.’’ 

(Response 30) We decline the 

commenter’s recommendation because 

it is unnecessary to clarify the final rule 

by adding the language requested by the 

commenter. Confidential business 

information, copyrighted information 

and trademarks, trade secrets, and other 

information and documents provided to 

the CPSC by a laboratory are all subject 

to protections from third party 

disclosure or other protections under 

existing applicable laws, and the final 

rule does not change that. 

G. Definitions 

(Comment 31) A commenter notes 

that the proposed rule defined a 

‘‘quality manager’’ for an accredited 

laboratory as having ‘‘defined 

responsibility and authority for ensuring 

the management system related to 

quality is implemented and followed at 

all times.’’ The commenter states that a 

laboratory may institute an ISO 9000- 

compliant management system and 

‘‘may not address the fulfillment of ISO/ 

IEC 17025, which may NOT include 

competence requirements for testing.’’ 

The commenter asserts that the 

definition appears to refer only to 

compliance with the management 

system and not to all sections of ISO/ 

IEC 17025:2005(E). 

(Response 31) The definition of a 

‘‘quality manager’’ provided in the 

Audit Final Rule (16 CFR 1112.3, 

Definitions is the same as the definition 

of a ‘‘quality manager’’ in section 4.1.5.i 

of ISO/IEC 17025:2005(E). We agree 

with the commenter that, regardless of 

the definition of a ‘‘quality manager,’’ a 

laboratory must comply with all the 

requirements of ISO/IEC 17025:2005(E) 

in order for its accreditation to be 

accepted by the CPSC. 

H. Retrospective Testing 

(Comment 32) One commenter notes 

that most of the previous NORs have 

provided for ‘‘retrospective testing’’ by 

laboratories, i.e., CPSC recognition of 

testing and certification using the new 

standard after the date of the method’s 

initial publication by the agency and 

before the NOR formally goes into effect. 

The commenter also notes that the two 

new CPSC lead substrate test methods 

have already been posted on the CPSC 

Web site, including a reference in the 

laboratory accreditation application 

page of that site, which indicates that 

laboratories can now begin applying for 

private accreditation. Thereafter, CPSC 

acceptance, to these new methods, 

should be allowed, despite the fact that 

there has been no retrospective testing 

allowance provided for in the proposed 

rule. The commenter recommends that 

the final rule allow retrospective testing 

using the new methods, effective back to 

April 10, 2012, the date those new 

methods were first published by the 

CPSC. 

(Response 32) We agree with the 

commenter regarding allowing 

retrospective testing for the new CPSC 

lead substrate test methods, CPSC–CH– 

E1001–08.2 and CPSC–CH–E1002–08.2, 

and we describe the circumstances 

where retrospective testing under those 

test methods and others will be 

accepted by the CPSC in section III.B.3.b 

of the preamble. 

III. Description of the Final Rule 

A. Subpart A—Purpose and Definitions 

1. Purpose (§ 1112.1) 

This section of the final rule, 

describing the major topics addressed in 

part 1112, is substantially the same as 

proposed. As in the proposal, this 

section notes 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. This 

section notes 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. The 

description of the purpose in § 1112.1 of 

the final rule is unchanged from the 

proposed rule, with the following 

exception. Proposed § 1112.1 used the 

phrase ‘‘that are accepted by’’ when 

referring to CPSC acceptance of a third 

party conformity assessment body’s 

acceptance of accreditation by the 

CPSC. The final rule replaces the phrase 

‘‘that are accepted by’’ used in proposed 

§ 1112.1 with ‘‘whose accreditations are 

accepted by’’ in the final rule because 

the revised language describes more 

accurately the CPSC acceptance of the 

accreditation process. This change is not 

a substantive change and has been made 

throughout the rule, where appropriate, 

for consistency. 

2. Definitions (§ 1112.1) 

a. Definitions Amending the Audit Rule 

Proposed § 1112.3 amended two 

definitions that appear in the audit final 

rule. One definition is the term ‘‘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. We did not receive any 

comments on this proposed definition 

and are finalizing the definition as 

proposed. 

The other definition from the audit 

rule that the Commission proposed to 

amend is ‘‘CPSC.’’ The rule discusses 

certain tasks that must be accomplished 

by the 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, revised the definition 

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

Product Safety Commission as an 

agency. The definition of ‘‘CPSC’’ in the 

final rule is unchanged from the 

proposed rule. 

b. Other Definitions 

Final § 1112.3 creates the following 

nine definitions; all are the same as 

proposed: 

Accept accreditation: The rule defines 

this term consistent with its use in 

section 14 of the CPSA. See, e.g., 15 

U.S.C. 2063(e)(1). The definition 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. 

Commission: The rule defines 

‘‘Commission’’ to mean the body of 

Commissioners appointed to the U.S. 

Consumer Product Safety Commission. 

In contrast, the agency as a whole was 

referred to, in this part, as the CPSC. 

CPSA: The rule defines this acronym 

to mean the Consumer Product Safety 

Act, 15 U.S.C. 2051–2089. 

Notice of requirements: The rule 

defines this term to mean a publication 

that provides the minimum 

qualifications necessary for a laboratory 

to become CPSC-accepted to test 


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children’s products pursuant to a 

particular children’s product safety rule. 

Scope: The rule defines this term to 

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 rule defines this term 

consistent with its use in section 14(e) 

of the CPSA, which the final rule 

implements. The proposed rule defined 

this term to mean that the CPSC has 

removed, for purposes of the testing of 

children’s products required in section 

14 of the CPSA, its acceptance of a 

laboratory’s accreditation, due to the 

laboratory’s failure to cooperate in an 

investigation under this part. 

Third party conformity assessment 

body: The rule defines this term to mean 

a laboratory. The preamble to the 

proposed rule discusses the 

development of this definition in detail. 

See 77 FR at 31109. In the preamble to 

this rule, for ease of reference, and for 

the convenience of the reader, the word 

‘‘laboratory’’ is used interchangeably 

with ‘‘third party conformity assessment 

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

only the full term, ‘‘third party 

conformity assessment body’’ is used. 

Undue influence: The rule defines 

‘‘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. The 

preamble to the proposed rule discusses 

the development of this definition in 

detail. See 77 FR at 31109. 

Withdraw: The rule defines this term 

consistent with its use in section 14(e) 

of the CPSA. The proposed rule defined 

‘‘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 

1. What are the types of third party 

conformity assessment bodies? 

(§ 1112.11) 

This section describes, for purposes of 

part 1112, the three types of third party 

conformity assessment bodies: 

independent, firewalled, and 

governmental. Section 1112.11(a) 

describes 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 1112.11(b) describes the 

circumstances that result in firewalled 

status. The rule considers a laboratory 

‘‘firewalled’’ if it is owned, managed, or 

controlled by a manufacturer or private 

labeler of a children’s product. The rule 

considers a laboratory owned by a trade 

association to be firewalled. 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 consideration will be given to 

the test results of association members 

or by discouraging reports of attempted 

undue influence by an association 

member. 

A laboratory would be considered to 

be ‘‘owned, managed, or controlled’’ by 

a manufacturer or private labeler if one 

(or more) of three characteristics apply. 

The first is 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 chose 

the 10 percent threshold ownership 

amount because it is our estimation that 

a manufacturer or private labeler who 

possesses less than a 10 percent 

ownership interest in a laboratory and 

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 3 

years indicates that applicants 

understand it easily 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 

rule also includes indirect ownership 

because an entity that owns a 

manufacturer or private labeler that, 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. 

The second circumstance that 

signifies that a laboratory is firewalled 

arises when the laboratory and a 

manufacturer or private labeler of a 

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 firewalled to ensure that its testing 

processes are independent. 

The third circumstance that results in 

firewalled status occurs when a 

manufacturer or private labeler of the 

children’s product has the ability to 

appoint any 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; the ability to 

hire, dismiss, or set the compensation 

levels for laboratory personnel. The 

ability to appoint the president or any 

of the senior internal governing body or 

to make personnel decisions indicates 

management and/or control of the 

laboratory. The preamble to the 

proposed rule discusses in more detail 

the development of the firewalled 

requirements in proposed 

§§ 1112.11(b)(1)(ii)(A)–(C). See 77 FR at 

31109–10. The Commission has chosen 

to change the proposed rule’s standard 

of ‘‘a majority’’ of a laboratory’s senior 

internal governing body to ‘‘any’’ 

member of that body. It is not clear by 

what means an independent laboratory 

that has any internal directors 

appointed by clients can remain 

completely independent, regardless of 

whether this ability is ever exercised. 

This was the only change to proposed 

§§ 1112.11(b)(1)(ii)(A)–(C) of the final 

rule. 

The fourth circumstance described in 

the proposed rule that would have 

resulted in firewalled status arises 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. As 

discussed in the response to Comment 

13 in section II.B. of the preamble, the 

Commission has decided to delete 

proposed § 1112.11(b)(1)(ii)(D) from the 

final rule. 

Section 1112.11(c) implements the 

CPSA section 14(f)(2)(B) definition of a 

‘‘governmental’’ laboratory as one 

‘‘owned or controlled in whole or in 

part by a government.’’ The proposed 

rule stated that, for purposes of this 


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part, ‘‘government’’ includes any unit of 

a national, territorial, provincial, 

regional, state, tribal, or local 

government. ‘‘Government’’ includes 

domestic, as well as foreign 

governmental entities. 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 rule 

describes the ways in which a 

government could reasonably be seen to 

have a means of operational control over 

a laboratory that has a financial or 

organizational connection to that 

government. 

As in the proposal, § 1112.11(c) lists 

six characteristics, any one of which 

triggers governmental laboratory status: 

• A governmental entity holds a 1 

percent or greater ownership interest, 

whether direct or indirect, in the 

laboratory (§ 1112.11(c)(1)). 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; 

• A governmental entity provides any 

direct financial investment or funding 

(other than fee-for-work) to the 

laboratory (§ 1112.11(c)(2)). This 

circumstance triggers governmental 

status because operational control of an 

enterprise may be affected by control or 

influence over its resources; 

• 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, the 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, at 

least in part, control of the laboratory 

(§ 1112.11(c)(3)); 

• If any of the laboratory’s 

management or technical personnel are 

government employees (§ 1112.11(c)(4)). 

Direct involvement by government 

personnel in the operation of a 

laboratory would represent control, in 

part; 

• If the laboratory has a subordinate 

position to a governmental entity in its 

external organizational structure 

(§ 1112.11(c)(5)). We consider 

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; or 

• 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 

determines whether the laboratory may 

accept particular offers of work, then the 

laboratory would be considered 

governmental (§ 1112.11(c)(6)). The 

preamble to the proposed rule discusses 

the criteria for governmental laboratory 

status in further detail. See 77 FR at 

31110–11. This provision of the final 

rule is unchanged from the proposed 

rule. 

2. How does a third party conformity 

assessment body apply for CPSC 

acceptance? (§ 1112.13) 

Section 1112.13 describes how a third 

party conformity assessment body may 

apply for CPSC acceptance of its 

accreditation. We are finalizing this 

section as proposed. Section 1112.13(a) 

describes the initial baseline 

requirements for any laboratory to 

apply. The laboratory must submit the 

following: 

• A completed application, CPSC 

Form 223. The laboratory also must 

update its CPSC Form 223 whenever 

any information previously supplied on 

the form changes. 

• A certificate of accreditation to ISO/ 

IEC Standard 17025:2005(E), ‘‘General 

requirements for the competence of 

testing and calibration laboratories.’’ 

• Accreditation by an accreditation 

body that is a signatory to the ILAC– 

MRA. All laboratories also are required 

to furnish their statement of scope, and 

the statement of scope would have to 

identify clearly the CPSC rule(s) and/or 

test method(s) for which CPSC 

acceptance is sought. 

The preamble to the proposed rule 

discusses the baseline requirements for 

accreditation in further detail. See 77 FR 

at 31111. 

Section 1112.13(b) describes the 

additional requirements for firewalled 

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

CPSA requires that a laboratory may be 

accepted as firewalled only if the 

Commission, by order, finds that: 

(i) [Acceptance] of the accreditation 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) The 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 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) Allegations 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 rule requires 

that a laboratory seeking CPSC-accepted 

firewalled status submit copies of 

various documents to the CPSC. Such 

laboratories must 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. 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, 

in addition to submitting the 

laboratory’s policies and procedures 

explaining that an allegation of undue 

influence may be reported 

confidentially to the CPSC. 

• Copies of training documents, 

including a description of the training 

program content, showing how 

employees are trained on the three 

policies just described. The rule 

requires this training annually. 

• Training records listing staff 

members who received the training and 

bearing their signatures. The training 

records must include training dates, 

location, and the name and title of the 

individual providing the training. 

• For firewalled laboratory 

applicants, two organizational charts. 

One chart must be an organizational 

chart(s) of the laboratory itself. It must 

include the names of all personnel, both 

temporary and permanent, and their 

reporting relationship within the 

laboratory. The other organizational 

chart must identify the reporting 


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15848 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 

relationships of the laboratory within 

the broader organization (using both 

position titles and staff names). 

• 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 preamble to the proposed rule 

discusses the additional requirements 

for firewalled laboratories in further 

detail. See 77 FR at 31112. 

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

mandates that the Commission may 

accept the accreditation of a 

governmental laboratory if: 

(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 

[section 14]; 

(iv) The 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) 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). 

The rule restates these statutory 

requirements and provides that, in order 

for the CPSC to make the necessary 

determinations, governmental 

laboratories must submit the following: 

• A description that can be in the 

form of a diagram. The description 

should illustrate the laboratory’s 

relationships with other entities, such as 

government agencies and joint venture 

partners. 

• Questionnaires completed by the 

governmental laboratory and the 

relevant governmental entity. The 

questionnaires are designed to elicit 

information related to the five statutory 

criteria. 

• A copy of an executed 

memorandum that addresses undue 

influence. The memorandum must 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 must be 

displayed prominently at the laboratory 

for as long as the laboratory’s 

accreditation is accepted by the CPSC. 

The memorandum must state certain 

policies and require that the laboratory’s 

policy is to reject undue influence. 

Additionally, the memorandum must 

require employees to report 

immediately, to their supervisor or to 

another designated laboratory official, 

any attempt at undue influence. Finally, 

the memorandum must state that the 

laboratory will not tolerate violations of 

the undue influence policy. 

• An attestation by a senior official of 

the governmental laboratory, who has 

the authority to make binding 

statements of policy on behalf of the 

laboratory. The official must 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 that are subject to CPSC 

jurisdiction and that are for export to 

the United States. Among other things, 

the senior official of the governmental 

laboratory must attest that the 

information in the laboratory’s 

application continues to be accurate, 

unless the laboratory notifies the CPSC 

otherwise. 

• If CPSC 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, the CPSC 

may require the relevant governmental 

entity to attest to the details of the new 

relationship or policy. 

The preamble to the proposed rule 

discusses the additional requirements 

for firewalled laboratories in further 

detail. See 77 FR at 31112–13. This 

section of the final rule is unchanged 

from the proposed rule, with one 

exception. Proposed 

§ 1112.13(c)(2)(iii)(3) would have 

required an executed memorandum, 

‘‘From senior management,’’ addressing 

undue influence. The description of the 

rule in the preamble to the proposed 

rule noted that the executed 

memorandum was required to be ‘‘from 

the senior management of the 

governmental laboratory.’’ 77 FR at 

31112. Final § 1112.13(c)(2)(iii)(3) has 

been revised by adding ‘‘of the third 

party conformity assessment body’’ after 

‘‘from senior management,’’ to clarify 

what ‘‘senior management’’ refers to in 

the codified text. 

Section 1112.13(d) states 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. This provision of the final 

rule is unchanged from the proposed 

rule. 

As in the proposal, § 1112.13(e) 

requires all application materials to be 

in English. 

Section 1112.13(f) requires that CPSC 

Form 223 and all required 

accompanying documentation be 

submitted electronically via the CPSC 

Web site. We have established an 

electronic application system that can 

be accessed via our Internet site at: 

http://www.cpsc.gov/en/Business— 

Manufacturing/Lab-Accreditation/. This 

provision of the final rule is unchanged 

from the proposed rule. 

Section 1112.13(g) reserves the 

authority to require additional 

information from an applicant 

laboratory to determine whether the 

laboratory meets the relevant criteria. 

This provision allows us to gather 

additional information if the initial 

information supplied by an applicant 

laboratory is insufficient. The rule also 

states that the CPSC, before acting on an 

application, may verify the accreditation 

certificate and statement of scope 

directly from the laboratory’s 

accreditation body. This provision of 

the final rule is unchanged from the 

proposed rule. 

Section 1112.13(h) provides that a 

laboratory may retract an application at 

any time before the CPSC has acted on 

it. The rule notes, however, that a 

retraction would not end or nullify any 

enforcement action that the CPSC is 

authorized to pursue. This provision of 

the final rule is unchanged from the 

proposed rule. 

Section 1112.13(i) contains the 

incorporation by reference language for 

ISO/IEC Standard 17025:2005(E): 

‘‘General requirements for the 

competence of testing and calibration 

laboratories,’’ which is required by the 

Office of the Federal Register. 

3. When can a third party conformity 

assessment body apply for CPSC 

acceptance for a particular CPSC rule or 

test method? (§ 1112.15) 

a. Regulatory Text 

Section 1112.15(a) states, 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 or test method once the 

Commission has published the 


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requirements for accreditation of third 

party conformity assessment bodies to 

assess conformity with that rule or test 

method. This section notes that a 

laboratory may apply for acceptance for 

more than one CPSC rule or test method 

at a time. 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. 

Finally, this section states for purposes 

of section 14 of the CPSA, a laboratory 

may be authorized to issue test results 

only for tests that fall within the CPSC 

rules or test methods for which its 

accreditation has been accepted by the 

CPSC. This provision of the final rule is 

unchanged from the proposed rule. 

Section 1112.15(b) lists the rules and 

test methods for which the Commission 

has published the requirements for 

accreditation of laboratories. The list in 

the final rule is current through the 

publication date of the final rule in the 

Federal Register. After the final rule 

publishes in the Federal Register, 

additions or revisions to this list in the 

future will be proposed as amendments 

to this section. The preamble to the 

proposed rule contains a more detailed 

discussion of the list of rules and test 

methods. See 77 FR at 31134–36. We are 

finalizing § 1112.15(b), as proposed, 

with the following exceptions. 

The preamble to the proposed rule (77 

FR at 31135) noted that proposed 

§§ 1112.15(b)(28) and (29), would 

contain two proposed revisions, which 

provided that, to be considered for 

CPSC-acceptance of accreditation to test 

for lead in children’s metal products 

(including metal jewelry), an applicant 

laboratory may have in its scope of 

accreditation 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). 

Comment 3 in section II.A of the 

preamble notes that CPSC test method 

CPSC–CH–E1001–08.2 was not included 

as an acceptable test method in the 

codified text of proposed 

§ 1112.15(b)(28). In the codified text of 

proposed § 1112.15(b)(28), test method 

CPSC–CH–E1001–08.2 was omitted 

inadvertently, although it was discussed 

in the preamble to the proposed rule, 

and we intended that test method 

CPSC–CH–E1001–08.2 be allowed 

under § 1112.15(b)(28). Therefore, 

§ 1112.15(b)(28) of the final rule 

expressly allows for the use of test 

method CPSC–CH–E1001–08.2. 

Additionally, as discussed in 

response to Comment 8 in section II.A 

of the preamble, CPSC staff has posted 

two new test methods, CPSC–CH– 

E1001–08.3 (http://www.cpsc.gov/ 

PageFiles/137829/CPSC–CH–E1001– 

08_3.pdf) and CPSC–CH–E1002–08.3 

(http://www.cpsc.gov/PageFiles/137832/ 

CPSC–CH–E1002–08_3.pdf), on the 

CPSC Web site. Sections 1112.15(b)(28) 

and (29) of the final rule have been 

revised to add test method CPSC–CH– 

E1001–08.3 as an option for laboratory 

accreditation for lead content in metal 

jewelry and children’s metal products. 

Section 1112.15(b)(30) of the final rule 

has also been revised to add test method 

CPSC–CH–E1002–08.3 as an option for 

laboratory accreditation for nonmetal 

products. 

Finally, editorial changes have been 

made to §§ 1112.15(b)(28), (29), and (30) 

of the final rule. In §§ 1112.15(b)(28) 

and (29) of the final rule, the full name 

of the 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)’’ is 

used the first time it appears in the 

provision; and thereafter, reference is 

made to the number of the test method 

because the name of the test method is 

clear from the context of the provision. 

The same change has been made to 

§ 1112.15(b)(30) regarding the reference 

to CPSC Test Method CPSC–CH–E1002– 

08, ‘‘Standard Operating Procedure for 

Determining Total Lead (Pb) in 

Nonmetal Children’s Products.’’ These 

changes are not intended to change 

those provisions substantively. Other 

than the changes just discussed, 

§§ 1112.15(b)(28) and (29) of the final 

rule have been finalized as proposed. 

b. Retrospective Testing 

In order to ease the transition to new 

third party testing requirements and to 

avoid a ‘‘bottlenecking’’ of products at 

laboratories at or near the effective date 

of required third party testing for 

children’s product, the Commission, in 

the past, and under certain conditions, 

has accepted certifications based on 

testing that occurred prior to the 

effective date for third party testing. The 

CPSC will accept retrospective testing 

under certain conditions for six new or 

revised requirements for accreditation 

listed in § 1112.15(b) of the final rule. 

The retrospective testing conditions 

listed here are based on other standards 

that previously allowed for retrospective 

testing. The details for retrospective 

testing for particular standards or tests 

methods are discussed below. 

Standards for Play Yards, Infant Swings, 

and Bed Rails (16 CFR parts 1221, 1223, 

and 1224) 

We will accept retrospective testing 

for 16 CFR parts 1221 (play yards), 1223 

(infant swings), and 1224 (portable bed 

rails) for the tests contained in those 

standards, 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(E) 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 the applicable 

standard. 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 the 

applicable standard at the time of initial 

Commission acceptance. For 

governmental third party conformity 

assessment bodies, accreditation of the 

body must be accepted by the 

Commission, even if the scope of 

accreditation did not include the tests 

contained in the applicable standard at 

the time of initial CPSC acceptance. 

• 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 June 10, 2013. 

• The test results show compliance 

with the applicable standard(s). 

• The children’s product was tested 

on or after the date of publication in the 

Federal Register of the final rule for: 

Æ 16 CFR part 1221, Play Yards 

(published August 29, 2012); 

Æ 16 CFR part 1223, Infant Swings 

(published November 7, 2012); and/or 

Æ 16 CFR part 1224, Portable Bed 

Rails (published February 29, 2012); 

and before June 10, 2013. 

• The laboratory’s accreditation 

remains in effect through June 10, 2013. 

Testing for Metal and Nonmetal 

Children’s Products (Test Methods 

CPSC–CH–E1001–08.2 and CPSC–CH– 

E1002–08.2) 

We will accept retrospective testing 

using test methods CPSC–CH–E1001– 

08.2 (for testing children’s metal 

products) and CPSC–CH–E1002–08.2 

(for testing nonmetal children’s 

products), if the following conditions 

are met: 

• The children’s product was tested 

by a third party conformity assessment 

body accredited to ISO/IEC 


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17025:2005(E) by a signatory to the 

ILAC–MRA at the time of the test. The 

scope of the third party conformity body 

accreditation must include test methods 

CPSC–CH–E1001–08.2 and/or CPSC– 

CH–E1002–08.2. For firewalled third 

party conformity assessment bodies, the 

Commission, by order, must have 

accredited it on or before the time that 

the children’s product was tested, even 

if the order did not include the test 

methods CPSC–CH–E1001–08.2 and/or 

CPSC–CH–E1002–08.2 at the time of 

initial Commission acceptance. For 

governmental third party conformity 

assessment bodies, accreditation of the 

body must be accepted by the 

Commission, even if the scope of 

accreditation did not include at the time 

of initial CPSC acceptance the test 

methods CPSC–CH–E1001–08.2 and/or 

CPSC–CH–E1002–08.2. 

• The third party conformity 

assessment body’s application for 

acceptance of its accreditation to the 

revised test methods is accepted by the 

CPSC on or after May 24, 2012, and 

before June 10, 2013. 

• The test results show compliance 

with limits on total lead content, as 

established in section 101 of the CPSIA. 

• The children’s product was tested 

on or after April 10, 2012 (the date the 

revised test methods were posted on the 

CPSC Web site) and before June 10, 

2013. 

• The laboratory’s accreditation 

remains in effect through June 10, 2013. 

Testing for Metal and Nonmetal 

Children’s Products (Test Methods 

CPSC–CH–E1001–08.3 and CPSC–CH– 

E1002–08.3) 

We will accept retrospective testing 

using test methods CPSC–CH–E1001– 

08.3 (for testing children’s metal 

products) and CPSC–CH–E1002–08.3 

(for testing nonmetal children’s 

products), 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(E) by a signatory to the 

ILAC–MRA at the time of the test. The 

scope of the third party conformity body 

accreditation must include test methods 

CPSC–CH–E1001–08.3 and/or CPSC– 

CH–E1002–08.3. For firewalled third 

party conformity assessment bodies, the 

Commission, by order, must have 

accredited it on or before the time that 

the children’s product was tested, even 

if the order did not include the test 

methods CPSC–CH–E1001–08.3 and/or 

CPSC–CH–E1002–08.3 at the time of 

initial Commission acceptance. For 

governmental third party conformity 

assessment bodies, accreditation of the 

body must be accepted by the 

Commission, even if the scope of 

accreditation did not include at the time 

of initial CPSC acceptance the test 

methods CPSC–CH–E1001–08.3 and/or 

CPSC–CH–E1002–08.3. 

• The third party conformity 

assessment body’s application for 

acceptance of its accreditation to the 

revised test methods is accepted by the 

CPSC on or after May 24, 2012, and 

before June 10, 2013. 

• The test results show compliance 

with limits on total lead content, as 

established in section 101 of the CPSIA. 

• The children’s product was tested 

on or after November 15, 2012 (the date 

the revised test methods were posted on 

the CPSC Web site) and before June 10, 

2013. 

The laboratory’s accreditation remains 

in effect through June 10, 2013. 

Toy Standard (ASTM F963–11) 

We will accept retrospective testing 

on children’s products conducted by a 

third party conformity assessment body 

accepted by the Commission for those 

tests in ASTM F963–11 that have no 

equivalent, or functionally equivalent, 

test in ASTM F963–08, 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(E) 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 F963–11. For firewalled third 

party conformity assessment bodies, the 

Commission, by order, must have 

accredited it, on or before the time that 

the children’s product was tested, even 

if the order, at the time of initial 

Commission acceptance, did not 

include the nonequivalent tests 

contained in ASTM F963–11. For 

governmental third party conformity 

assessment bodies, accreditation of the 

body must be accepted by the 

Commission, even if the scope of 

accreditation at the time of initial CPSC 

acceptance did not include the 

nonequivalent tests methods contained 

in ASTM F963–11. 

• 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 June 10, 2013. 

• The test results show compliance 

with the nonequivalent section(s) of 

ASTM F963–11. 

• The children’s product was tested 

on or after February 22, 2012 (the date 

that the Commission voted to approve 

ASTM F963–11 as a mandatory 

standard), and before June 10, 2013. 

• The third party conformity 

assessment body’s accreditation remains 

in effect through June 10, 2013. 

4. How will the CPSC respond to each 

application? (§ 1112.17) 

This section establishes the 

procedures related to CPSC action on a 

third party conformity assessment 

body’s application for CPSC acceptance 

of its accreditation. We are finalizing 

this section as proposed. 

CPSC staff will review each 

application and may contact applicant 

laboratories with questions or to request 

submission of missing information. 

Consistent with section 14(f)(2)(D) of 

the CPSA, 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. 

The CPSC will communicate its 

decision on each application, in writing, 

to the applicant; the written decision 

may be by electronic mail. 

5. How does the cpsc publish 

information identifying third party 

conformity assessment bodies that have 

been accepted? (§ 1112.19) 

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

of the CPSA, § 1112.19 provides 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. The rule 

states that the CPSC will 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, the CPSC 

will 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 its 

acceptance of a laboratory’s 

accreditation. This provision of the final 

rule is unchanged from the proposed 

rule. 


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6. May a third party conformity 

assessment body use testing methods 

other than those specified in the 

relevant cpsc rule or test method? 

(§ 1112.21) 

We are finalizing this section as 

proposed. It requires 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 CPSC is requiring 

that test methods be specified 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 is a common understanding 

between the CPSC and CPSC-accepted 

laboratories. Second, by specifying the 

test method, greater consistency among 

tests conducted at different CPSCaccepted laboratories is established. 

Variations between laboratories are 

reduced. Finally, the specified test 

method serves as a common procedure 

that accreditation bodies can use to 

evaluate a laboratory for a particular 

CPSC rule or test method. By evaluating 

to a CPSC-specified test method, 

accreditation bodies can determine 

whether the laboratory meets 

competency requirements to carry out a 

particular test. 

7. May a CSPC-accepted third party 

conformity assessment body subcontract 

work conducted for purposes of section 

14 of the CPSA? (§ 1112.23) 

This section of the final rule is 

unchanged from the proposed rule. It 

prohibits subcontracting of tests 

conducted for purposes of section 14 of 

the CPSA, unless the work is 

subcontracted 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. 

The purpose of requiring a third party 

conformity assessment body 

subcontractor to be a CPSC-accepted 

laboratory is to promote competent and 

consistent test results across all 

laboratories that conduct testing of 

children’s products under section 14 of 

the CPSA. 

The provisions of part 1112 apply to 

all CPSC-accepted laboratories, even if 

they are a prime contractor and/or a 

subcontractor. 

8. What are a third party conformity 

assessment body’s recordkeeping 

responsibilities? (§ 1112.25) 

This section requires third party 

conformity assessment bodies to retain 

certain records related to the tests 

conducted for purposes of section 14 of 

the CPSA. All required records must be 

legible. 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 5 

years from the date the test was 

conducted. These requirements are 

unchanged from the proposed rule. 

Proposed § 1112.25(a)(2) required, in 

the case of a test report for a test 

conducted by a CPSC-accepted 

laboratory acting as a sub-contractor, 

that the prime contractor’s test report 

identify clearly 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. This 

provision of the final rule has been 

changed to require only that the 

subcontractor’s laboratory test report be 

made available to the CPSC, upon 

request, but not necessarily appended to 

the prime contractor’s test report, as 

discussed in the response to Comment 

28 in section II.F of the preamble. 

The remaining subsections of 

§ 1112.25(a) are unchanged from the 

proposed rule. For purposes of section 

14 of the CPSA, where a report, 

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 5 years from the date the test 

was conducted. 

Any and all laboratory internal 

documents describing testing protocols 

and procedures (such as instructions, 

standards, manuals, guides, and 

reference data) that have been applied to 

a test conducted for purposes of section 

14 of the CPSA must be retained for a 

period of at least 5 years from the date 

such test was conducted. 

As noted in the response to comment 

section of this preamble, we are 

modifying § 1112.25(b). The proposed 

rule stated 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. If the records are not in 

English, copies of the original records 

must be made available to the CPSC 

within 48 hours, and an English 

translation of the records must be made 

available by the laboratory within 30 

calendar days of the date the CPSC 

requested an English translation. As 

discussed in the response to Comment 

29 in section II.F of the preamble, we 

are revising § 1112.25(b) to remove the 

‘‘within 48 hours’’ language in the 

proposed rule and replacing it with: 

‘‘Such as through an Internet Web site.’’ 

The revised language is being added to 

be consistent with the recordkeeping 

language in 16 CFR part 1107 (testing 

and labeling rule) and 16 CFR part 1109 

(component part testing rule), which 

require submission of records, upon 

request, but do not specify a time frame 

within which the records must be 

submitted and allows for electronic 

records ‘‘such as through an Internet 

Web site.’’ Implicit in the requirement 

to submit records to the CPSC upon 

request, is the commenter’s concept of 

‘‘within a reasonable time given the 

particular circumstances.’’ The time 

frame necessary to respond to a 

document request by the CPSC, by its 

nature, is required to be determined on 

a case-by-case basis. Therefore, stating 

an explicit time frame, such as ‘‘48 

hours,’’ as the proposed rule specified, 

would not fit the many different 

circumstances that might occur when 

the CPSC requests records. 

9. Must a third party conformity 

assessment body allow cpsc inspections 

related to investigations? (§ 1112.27) 

This section of the final rule is 

unchanged from the proposal. It 

requires 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 CPSCacceptance of its accreditation. The 

CPSC will 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 

§ 1112.45. The preamble to the proposed 

rule discusses this condition of CPSCacceptance in further detail. See 77 FR 

at 31118. 

10. How does a third party conformity 

assessment body voluntarily 

discontinue its participation with the 

CPSC? (§ 1112.29) 

This section is unchanged from the 

proposed rule. It provides 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. To discontinue 

voluntarily its participation as a CPSCaccepted laboratory, the laboratory must 

notify the CPSC in writing. This 

notification may be sent electronically. 

The notice must include the name, 

address, phone number, and electronic 

mail address of the laboratory and the 

person responsible for submitting the 


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request. The notice also must include 

the scope of the discontinuance; the 

beginning date for the discontinuance; a 

statement that the laboratory 

understands that in the future, if 

desired, 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. 

The CPSC may verify the information 

submitted in a notice of voluntary 

discontinuance. Either upon receipt of a 

notice for voluntary discontinuance 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 as of the 

date provided, and for the scope 

indicated in the notice. 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. When must an audit be conducted? 

(§ 1112.35(b)) 

As explained in the audit final rule 

published in the Federal Register on 

May 24, 2012 (77 FR 30704), 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 reassessment portion of an audit is 

conducted, at a minimum, at the 

frequency established by its 

accreditation body. 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. 

We are finalizing these provisions as 

proposed. Section 1112.35(b) 

established when the examination 

portion of an audit must be conducted. 

This section requires each laboratory to 

submit a new CPSC Form 223 and 

applicable accompanying 

documentation no less than every 2 

years. 

This section notes that 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. 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 § 1112.35(b)(1). If the 

laboratory also intends to satisfy the 

audit requirement of § 1112.35(b)(1), it 

must indicate that intent clearly when it 

submits a CPSC Form 223. In addition, 

the laboratory must upload all 

applicable accompanying 

documentation. 

Section 1112.35(b)(3) states 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, CPSC 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 

1. What are the possible adverse actions 

the CPSC may take against a third party 

conformity assessment body? 

(§ 1112.41) 

This section lists the possible adverse 

actions that the CPSC may take against 

a third party conformity assessment 

body: Denial of acceptance of 

accreditation; suspension of acceptance 

of accreditation; or withdrawal of 

acceptance of accreditation. It also states 

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. 

This section of the final rule is 

unchanged from the proposed rule. 

2. What are the grounds for denial of an 

application? (§ 1112.43) 

This section, unchanged from the 

proposal, lists the grounds for denying 

an application for acceptance of 

accreditation from a third party 

conformity assessment body. It notes 

that 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 deficiency, constitute grounds for 

denial of an application. 

Submission of false or misleading 

information concerning a material 

fact(s) on an application, or concerning 

any other information provided to the 

CPSC related to a third party conformity 

assessment body’s ability to become or 

remain a CPSC-accepted third party 

conformity assessment body are grounds 

for denial of an application. 

The CPSC may deny an application if 

the applicant laboratory fails to satisfy 

the necessary requirements described in 

§ 1112.13, such as ISO/IEC 

17025:2005(E) accreditation by an 

ILAC–MRA signatory accreditation body 

for the scope for which acceptance of 

accreditation is being sought. 

The CPSC’s denial of an application 

will follow the process described in 

§ 1112.51 of this part. 

3. What are the grounds for suspension 

of CPSC acceptance? (§ 1112.45) 

This section, unchanged from the 

proposal, provides that the CPSC may 

suspend 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. 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 the 

laboratory fails to cooperate with an 

investigatory inspection under 

§ 1112.27. 

A suspension will last until the 

laboratory complies, to CPSC’s 

satisfaction, with required actions, as 

outlined in the initial notice described 

in proposed § 1112.51(b), or until the 

CPSC withdraws acceptance of the 

laboratory. The suspension of CPSC 

acceptance will be lifted if the CPSC 

determines that the third party 

conformity assessment body is 

cooperating sufficiently with the 

investigation. The suspension would be 

lifted as of the date of the CPSC’s 

written notification to the laboratory, 

which may be by electronic mail, 

indicating that the CPSC is lifting the 

suspension. 

4. What are the grounds for withdrawal 

of CPSC acceptance? (§ 1112.47) 

This section, unchanged from the 

proposal, establishes the grounds upon 

which the CPSC may withdraw 

acceptance of the accreditation of a 

third party conformity assessment body 

for any portion of its CPSC scope. 

One basis for withdrawal is when a 

manufacturer, private labeler, 


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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. The preamble to the proposed 

rule discusses the exertion of undue 

influence in further detail. 77 FR at 

31120. 

A second ground for withdrawal 

occurs when a third party conformity 

assessment body has failed to comply 

with an applicable protocol, standard, 

or requirement under subpart C of this 

part. 

Finally, the CPSC may withdraw its 

acceptance of the accreditation of a 

laboratory if the laboratory fails to 

comply with any provision in subpart B 

of this part. Subpart B establishes 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. 

5. How may a person submit 

information alleging grounds for adverse 

action, and what information should be 

submitted? (§ 1112.49) 

This section, unchanged from the 

proposal, allows 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. 

This section also lists the information to 

be included in a submission alleging 

grounds for adverse action. 

• The submission should include the 

name and contact information of the 

person making the allegation. 

• 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. 

• 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. 

• 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. 

• A submission of grounds for 

adverse action should include a 

description of the impact of the acts 

and/or omissions, where known. 

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. 

6. What are the procedures relevant to 

adverse actions? (§ 1112.51) 

This section, unchanged from the 

proposal, describes the process by 

which the CPSC 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. The CPSC would use the 

Procedures for Investigations, 

Inspections, and Inquiries, 16 CFR part 

1118, subpart A, to investigate under 

this part. 

An investigation under this part may 

include: Any act the CPSC 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. 

The CPSC will begin an investigation 

by providing written notice, which may 

be electronic, to the laboratory. The 

notice will inform the laboratory that we 

have received information sufficient to 

warrant an investigation, and describe 

the information received by the CPSC, 

as well as describe the investigative 

process. The notice also will inform the 

laboratory that failure to cooperate with 

a CPSC investigation is grounds for 

suspension. 

Any 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, constitutes a notice of 

investigation for purposes of this 

section. The examination portion of an 

audit under § 1112.33(c) of this part 

(which is currently in effect) constitutes 

an investigation for purposes of this 

section. 

If, after investigation, the CPSC 

determines that grounds for adverse 

action exist, and the CPSC proposes to 

take an adverse action against a 

laboratory, the CPSC will 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 must: 

• Include the proposed adverse 

action; 

• Specify the grounds upon which 

the proposed adverse action is based; 

• Provide findings of fact to support 

the proposed adverse action; 

• When appropriate, specify actions a 

third party conformity assessment body 

must take to avoid an adverse action; 

• Include consideration of the criteria 

set forth in § 1112.51(d)(1), when the 

proposed adverse action is withdrawal; 

and 

• Specify 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. 

Under § 1112.53, 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. 

Section 1112.51(c) addresses how a 

laboratory may respond to the initial 

notice. The proposed rule required the 

laboratory’s response to be in writing, 

which may be by electronic mail, and in 

English. The response may 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. 

The written response from the 

laboratory must state the laboratory’s 


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reasons why the ground(s) for adverse 

action do 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, the CPSC will 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, the CPSC may proceed, 

without further delay, to a Final Notice, 

as described in § 1112.51(e). 

Section 1112.51(d) addresses 

proceedings for adverse actions. The 

CPSC 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. 

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 

§ 1112.51(d)(3), the CPSC will 

determine what action is appropriate 

under the circumstances. Any 

suspension or withdrawal of a 

firewalled laboratory would occur by 

order of the Commission. 

The CPSC may withdraw its 

acceptance of the accreditation of a 

laboratory on a permanent or temporary 

basis. 

If the CPSC withdraws its acceptance 

of accreditation of a laboratory, it may 

establish requirements for the 

reacceptance of the laboratory’s 

accreditation. Any such requirements 

would be related to the reason(s) for the 

withdrawal. 

Section 1112.51(e) describes the Final 

Notice for an adverse action. If, after 

reviewing a laboratory’s response to a 

notice, and conducting additional 

investigation, where necessary, the 

CPSC determines that grounds for 

adverse action exist, the CPSC will send 

a Final Notice to the laboratory, in 

writing, which may be electronic. The 

Final Notice will state: 

• The adverse action that we are 

taking; 

• The specific grounds on which the 

adverse action is based; 

• 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 

set forth in § 1112.51(d)(1); 

• When the adverse action is 

withdrawal, whether the withdrawal is 

temporary or permanent, and, if the 

withdrawal is temporary, the duration 

of the withdrawal. 

• The Final Notice will 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 will inform the 

laboratory that the CPSC Web site will 

be updated to reflect adverse actions 

taken against a previously CPSCaccepted laboratory. 

• The Final Notice will inform the 

laboratory whether it may submit a new 

application. 

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. 

Section 1112.51(g) addresses 

Administrative Appeals. Except for 

cases covered in § 1112.51(g)(2), a 

laboratory could file an Administrative 

Appeal with the CPSC Office of the 

Executive Director. The Administrative 

Appeal must be sent by mail within 30 

calendar days of the date on the Final 

Notice; § 1112.51(g) provides the 

appropriate mailing and electronic mail 

addresses. The rule requires 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, the 

Executive Director 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. 

Section 1112.51(g)(2) addresses 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 CPSC Office of the 

Secretary by mail within 30 calendar 

days of the date on the Final Notice. The 

rule requires 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. Can the CPSC immediately withdraw 

its acceptance of the accreditation of a 

third party conformity assessment body? 

(§ 1112.53) 

This section, unchanged from the 

proposal, establishes a means of 

withdrawing immediately and 

temporarily 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 § 1112.51. 

When it is in the public interest to 

protect health and safety, and 

notwithstanding any other provision of 

this part, the CPSC may immediately 

and temporarily withdraw our 

acceptance of a laboratory’s 

accreditation for any portion of its CPSC 

scope while it pursues an investigation 

and potential adverse action. ‘‘In the 

public interest to protect health and 

safety’’ means 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. 

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 time frames described in § 1112.51, 

the following time frames 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. 

If the laboratory is already the subject 

of an investigation or adverse action 


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3The CPSC has recognized the accreditation of 

410 laboratories worldwide (as of January 15, 2013). 

However, most of the laboratories are located in 

other countries. Only domestic firms are considered 

for the purposes of the RFA. 

process, the immediate and temporary 

withdrawal will remain in effect until 

either the CPSC communicates in 

writing that the immediate and 

temporary withdrawal has been lifted, 

the investigation concludes, and the 

CPSC does not propose an adverse 

action, or the adverse action process 

concludes with denial, suspension, or 

withdrawal. 

If the laboratory is not already the 

subject of an investigation or adverse 

action process under § 1112.51, an 

investigation under § 1112.51(a) will be 

launched based on the same information 

that justified the immediate and 

temporary withdrawal. 

8. Will the CPSC publish adverse 

actions? (§ 1112.55) 

This section, unchanged from the 

proposal, states that, 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. In 

addition, after issuance of a final 

adverse action, the CPSC will amend its 

Web site listing of CPSC-accepted 

laboratories to reflect the nature and 

scope of such adverse action. 

E. Conduct and Scope of Inspections (16 

CFR 1118.2) 

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 sought to amend 

§ 1118.2(a) in two ways. First, it 

included firewalled third party 

conformity assessment bodies as entities 

that the CPSC 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 § 1112.27. 

Second, it removed 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. 

To be consistent with the inspection 

provision at § 1112.27, the references to 

‘‘product’’ must be broad enough to 

include more than just products subject 

to CPSA safety standards. The final rule 

is unchanged from the proposed 

amendments to the existing provisions 

of § 1118.2 of the proposed rule. 

IV. Regulatory Flexibility Act 

A. Introduction 

The Regulatory Flexibility Act (RFA) 

requires that final rules be reviewed for 

their potential economic impact on 

small entities, including small 

businesses. Section 604 of the RFA 

generally requires that the Commission 

prepare a final regulatory flexibility 

analysis when it promulgates a final 

rule. The final regulatory flexibility 

analysis must describe the impact of the 

rule on small entities. Specifically, the 

final regulatory flexibility analysis must 

contain: 

• A succinct statement of the 

objectives of, and legal basis for, the 

rule; 

• A summary of the significant issues 

raised by public comments in response 

to the initial regulatory flexibility 

analysis, a summary of the assessment 

of the agency of such issues, and a 

statement of any changes made in the 

proposed rule as a result of such 

comments; 

• A description of, and where 

feasible, an estimate of, the number of 

small entities to which the rule will 

apply; 

• A description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the 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; and 

• A description of the steps the 

agency has taken to reduce the 

significant economic impact on small 

entities, consistent with the stated 

objectives of applicable statutes, 

including a statement of the factual, 

policy, and legal reasons for selecting 

the alternative adopted in the rule, and 

why each one of the other significant 

alternatives to the rule considered by 

the agency, which affect the impact on 

small entities, was rejected. 

B. Comments on the Initial Regulatory 

Flexibility Analysis 

The preamble to the proposed rule 

contained the initial regulatory 

flexibility analysis (IRFA). The CPSC 

received six public comments in 

response to the notice of proposed 

rulemaking. None of the comments 

addressed the content of the IRFA or its 

findings. 

C. Description and Estimate of the Small 

Entities to Which the Final Rule Applies 

The final rule applies to laboratories 

that intend to test children’s products 

for conformance to children’s product 

safety rules under Section 14 of the 

CPSA. The final rule does not impose 

any requirements on laboratories that do 

not intend to provide this service. 

Although there are 5,198 firms in the 

United States classified as ‘‘testing 

laboratories’’ (NAICS code 54138), only 

a small subset of these laboratories is 

expected to provide third party 

conformity assessments of children’s 

products for purposes of section 14 of 

the CPSA. As of October 5, 2012, the 

CPSC has accepted the accreditation of 

92 laboratories located in the United 

States.3 This number could increase, 

somewhat, over the next year or so, as 

new notices of requirements for 

accreditation are issued. 

According to criteria established by 

the U.S. Small Business Administration 

(SBA), a laboratory is considered small 

if its revenue is less than $14 million a 

year. Of the 92 laboratories located in 

the United States with CPSC-accepted 

accreditations, 58 (or 63 percent) could 

be small businesses, according to the 

SBA criteria. 

D. Compliance and Recordkeeping 

Requirements of the Rule 

1. Acceptance of Accreditation 

The final rule establishes the 

requirements for CPSC acceptance of the 

accreditation of a laboratory. Therefore, 

the rule applies only to laboratories that 

intend to provide third party testing of 

children’s products in support of the 

certifications required by section 

14(a)(2) of the CPSA. The final rule does 

not impose any requirements on 

laboratories that do not intend to 

provide these services. 

The final rule requires that, as a 

condition of CPSC acceptance of its 

accreditation, the laboratory must be 

accredited to ISO/IEC 17025:2005(E). 

The accreditation must be made by an 

accreditation body that is a signatory to 

the ILAC–MRA. The scope of the 

accreditation must list the specific 

regulations or test methods contained in 

the product safety rules or in the notices 

of requirements that are required as the 

basis for certifying that children’s 

products conform to the applicable 

product safety rules. This aspect of the 

final rule would simply codify the 

existing conditions for CPSC acceptance 

of accreditation that have been stated in 

every NOR published previously by the 

Commission. 


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The final rule requires that 

laboratories provide the Commission 

with their accreditation and scope 

documents. These records are normally 

generated during the accreditation 

process and can be provided to the 

CPSC electronically. The application for 

CPSC acceptance of accreditation would 

be accomplished using CPSC Form 223, 

an electronic application form. 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 

Form 223, and the related documents, 

are skills that a competent, accredited 

laboratory would be expected to 

possess. 

The final rule also requires 

laboratories that are managed, owned, or 

controlled by a manufacturer or private 

labeler (or, firewalled laboratories) to 

submit additional materials, as 

described in § 1112.13(b). The 

acceptance of a firewalled laboratory’s 

accreditation occurs, by Commission 

order, only after the Commission has 

made certain findings based on the 

additional documents. 

The final rule also establishes 

additional requirements as described in 

§ 1112.11 for Commission acceptance of 

the accreditation of laboratories that are 

owned or controlled, in whole or in 

part, by a government. The CPSC has 

accepted the accreditation of three 

conformity assessment bodies located in 

the United States that are owned by or 

affiliated with government entities, 

none of which meet the definition of a 

‘‘small entity.’’ Laboratories that are 

owned or controlled by foreign 

governments do not meet the definition 

of a ‘‘small entity’’ under the RFA. 

In addition to the baseline 

requirements (accreditation to ISO/IEC 

17025:2005(E) by a signatory to the 

ILAC–MRA and submission of CPSC 

Form 223 and related documents to the 

CPSC), laboratories that are owned or 

controlled by a government entity must 

provide additional information and 

materials to the CPSC, as described in 

§ 1112.11, so that the CPSC can 

determine whether the laboratory 

satisfies the criteria for the acceptance 

of the accreditation of a governmental 

laboratory. 

There are no fees payable to the CPSC 

associated with applying for CPSC 

acceptance of accreditation. The amount 

of time required to complete Form 223 

and to submit the related documents to 

the CPSC is less than 1 hour for most 

laboratories. The amount of time could 

be somewhat higher for firewalled and 

governmental laboratories, which are 

required to submit additional materials. 

The costs of obtaining ISO/IEC 

17025:2005(E) accreditation by an 

ILAC–MRA accreditation body 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. The 

laboratory will also probably be charged 

for the travel, lodging, and meals of the 

assessor(s) conducting the assessment. 

Based on the above discussion, a 

laboratory seeking accreditation in one 

field of testing can expect to pay around 

$4,800 in fees, plus travel, lodging, and 

meal expenses. The cost could be higher 

if the assessment takes longer than 2.5 

days. If the laboratory is seeking 

accreditation in more than one field, 

such as chemical and mechanical 

testing, the cost will be higher because 

there will be additional fees for each 

field, and the assessment will likely take 

more time. There will be some cost to 

the laboratory in terms of laboratory 

personnel, who must prepare 

documents for the assessment and also 

work with the assessors during the 

assessment. 

If a laboratory is already accredited to 

ISO/IEC 17025:2005(E) by an 

accreditation body that is a signatory to 

the ILAC–MRA, and the laboratory is 

seeking simply to expand its scope of 

accreditation to include specific CPSC 

tests, then the cost to the laboratory will 

be substantially less. In some cases, if 

the 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 what 

would be required for a full initial 

assessment. 

For most children’s product safety 

rules, the required test methods were 

specified in the regulation that 

established the safety rule. However, in 

the case of the requirements for lead 

content of children’s products, the test 

methods are specified in the notices of 

requirements for accreditation, which 

are included in the final rule. The final 

rule expands 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 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. 

Each ILAC–MRA signatory 

accreditation body has requirements for 

the periodic reassessment of accredited 

laboratories. The Commission has 

established the auditing requirements 

for maintaining CPSC acceptance of a 

laboratory’s accreditation in the 

separate, but related, rule on periodic 

audits (16 CFR §§ 1112.30 through 

1112.39), which is currently in effect. 

2. Recordkeeping Requirements 

The final rule requires that third party 

conformity assessment bodies maintain 

certain records associated with the 

testing conducted for purposes of 

section 14 of the CPSA for at least 5 

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 they are related 

to tests conducted for purposes of 

section 14 of the CPSA. Additionally, all 

internal documents describing testing 

protocols and procedures (such as 

instructions, standards, manuals, 

guides, and reference data) that applied 

to a test conducted for purposes of 

section 14 of the CPSA must be retained 

for a period of at least 5 years from the 

date such test was conducted. The cost 

of storing the records for 5 years could 

be less than $200, if the records are 

stored in electronic format; but the costs 

could be several thousand dollars, or 

more, if stored on paper in commercial 

warehouse space. 

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. 

If the records are not in the English 

language, the third party conformity 

assessment body must make copies of 

the original (non-English language) 

records available to the CPSC, 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. 

3. Grounds and Procedures for Adverse 

Actions Against Laboratories 

The final rule also establishes the 

grounds and procedures that the CPSC 

would use to take adverse actions 

against a laboratory. Adverse actions 

include: Denying the acceptance of the 


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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 adverse actions include: Failing to 

comply with CPSC requirements; failing 

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 establishes 

the requirements for the notices that the 

CPSC must provide to laboratories 

before taking adverse actions, the time 

limits for responses by the laboratories 

to the notices, and the appeal rights of 

the laboratories regarding proposals of 

adverse action. 

During an investigation of an 

allegation, some costs would be 

incurred by the laboratory for actions 

such as making employees available for 

interviews with CPSC investigators and 

providing the CPSC with documents or 

records requested by the investigators 

and allowing CPSC investigators access 

to its facilities. The costs 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 the 

laboratory chooses to reply. The number 

of investigations of laboratories that the 

CPSC may open is not known. 

E. Economic Impact on Small Entities 

and Significant Alternatives Considered 

1. Expected Economic Impact on Small 

Entities 

Laboratories that intend to provide 

the third party testing services required 

by section 14 of the CPSA will incur 

some costs to obtain CPSC acceptance of 

their accreditation. If the laboratory is 

not already accredited to ISO/IEC 

17025:2005(E) 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. 

The costs could be significantly lower 

for laboratories that are already 

accredited to ISO/IEC 17025:2005(E) by 

a body that is an ILAC–MRA signatory. 

There will also be some cost to the 

laboratory to prepare documents for the 

assessment and to work with the 

assessors. If the CPSC opened an 

investigation of the laboratory, the 

laboratory would likely incur some 

costs in connection with the 

investigation. The final rule requires 

laboratories to maintain certain records 

for 5 years, which could also add to a 

laboratory’s costs, depending upon how 

it maintains the records. 

As noted, the requirements would 

apply only to those laboratories that 

intend to provide the third party testing 

services for purposes of certifying 

children’s products under section 14 of 

the CPSA. The only laboratories that are 

expected to provide such services are 

those that anticipate receiving sufficient 

revenue from providing the testing 

services 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. 

2. Alternatives Considered 

Although the final rule is not 

expected to have a significant adverse 

impact on a substantial number of small 

entities, CPSC staff considered 

alternatives that could have reduced the 

costs associated with the accreditation 

process or providing the testing services 

to some laboratories. The alternatives 

considered were accepting the 

accreditation of laboratories that were 

not accredited by a signatory to the 

ILAC–MRA and allowing the use of XRF 

techniques for determining compliance 

with the lead content requirements for 

more materials. 

a. Accepting the Accreditation of 

Laboratories Not Accredited by ILAC– 

MRA Signatories 

CPSC staff considered accepting the 

accreditation of laboratories that have 

been accredited by accreditation bodies 

that are not signatories to the ILAC– 

MRA. This alternative could have 

reduced the cost of obtaining CPSC 

acceptance of their accreditation for 

laboratories accredited by bodies that 

were not ILAC–MRA signatories. Under 

the final 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, despite 

being accredited by an accrediting body 

that was not a signatory to the ILAC– 

MRA. This alternative would not have 

any impact on laboratories that are not 

accredited by any accreditation body. 

This alternative was not included in 

the final rule because it would not meet 

the objectives that CPSC staff have 

identified for a program to meet the 

laboratory accreditation requirements in 

the CPSA. In establishing the 

requirements for the laboratory 

accreditation program, the CPSC staff 

considered timelines established by the 

CPSA and the fact that children’s 

products destined for the U.S. market 

are manufactured in nations throughout 

the world and established several 

objectives for the laboratory 

accreditation program. These objectives 

were to: 

• Delegate the core elements of a 

CPSC accreditation program to an entity 

that was established and had acceptance 

on a multinational level and that 

followed internationally recognized 

standards for assessing the competence 

of laboratories and for the processes and 

standards used by accreditation bodies 

that evaluate such laboratories. In 

addition, CPSC staff sought a program 

that included regular evaluation of the 

accreditation bodies to ensure those 

bodies continued to follow the same, 

internationally recognized, set of 

standards and procedures; 

• Designate one entity that could 

bring on board, on a multinational level, 

a large 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 

• Avoid designation to accreditation 

programs or entities that are recognized 

only in a specific region, nation, or 

locality. 

In addition to the objectives outlined 

above, the Commission also seeks to 

keep the program as simple as possible, 

avoid any perceived notions of barriers 

to fair trade practices, and ensure that 

the program established would be 

manageable with agency resources. The 

Commission staff found that the ILAC– 

MRA signatory program met those 

objectives. Although CPSC staff 

recognizes that there are other types of 

accreditation organizations and 

accreditation bodies for different types 

of conformity assessment programs, 

some of these organizations are for very 

specific industry or governmental 

sectors or are only applicable to certain 

regions. Designations to such 

organizations would not meet all of the 

objectives established by CPSC staff for 

the laboratory accreditation program. 

b. Allowing XRF Test Methods for Lead 

Content for More Materials 

The CPSC has received a number of 

requests to allow more extensive use of 

XRF analysis in meeting the third party 

test requirements because XRF analysis 

is significantly less expensive than the 

other test methods for lead content 

testing. Based on the CPSC’s continuing 

research of testing methods, the 

Commission has approved the use of 

certain XRF methods for determining 


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the lead content of homogenous 

polymer components and paints, and 

the final rule would further allow 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 final 

rule does not expand the approved use 

of XRF to cover all materials or 

substances. 

V. Paperwork Reduction Act 

This rule contains information 

collection requirements under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The preamble to the 

proposed rule (77 FR at 31126–30) 

discussed the information collection 

burden of the proposed rule and 

specifically requested comments on the 

accuracy of our estimates. We did not 

receive any comments concerning the 

information collection burden of the 

proposal, and the final rule does not 

make any changes to that burden. The 

OMB has approved the information 

collection requirements in this rule, and 

the OMB control number for such 

approval is OMB 3041–0156. 

VI. Environmental Considerations 

The final 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. 

VII. Preemption 

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 

preemptive effect of this rule would be 

determined in an appropriate 

proceeding by a court of competent 

jurisdiction. 

VIII. Effective Date 

The Commission proposed that the 

final rule would become effective 90 

days after publication in the Federal 

Register. We received no comments 

regarding the effective date. Therefore, 

the final rule will become effective 90 

days after publication of the final rule 

in the Federal Register. 

List of Subjects 

16 CFR Part 1112 

Administrative practice and 

procedure, Audit, Consumer protection, 

Incorporation by reference, Reporting 

and recordkeeping requirements, Third 

party conformity assessment body. 

16 CFR Part 1118 

Administrative practice and 

procedure, Consumer protection, 

Investigations. 

Therefore, the Commission amends 

Title 16 of the Code of Federal 

Regulations by adding: 

Accordingly, the CPSC amends 16 

CFR parts 1112 and 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. Add § 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 whose 

accreditations 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 CPSC-accepted third party 

conformity assessment body; the audit 

requirement applicable to CPSCaccepted 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 by: 

a. Revising the definitions of ‘‘Audit’’ 

and ‘‘CPSC,’’ and 

b. Adding definitions for ‘‘Accept 

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

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

‘‘Suspend,’’ ‘‘Third party conformity 

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

and ‘‘Withdraw’’ 

The revisions and 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 have its 

accreditation 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. 


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Third party conformity assessment 

body means a 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. Add 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 or 

test method? 

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 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; or 

(C) A manufacturer or private labeler 

of the children’s product has the ability 

to appoint any 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, the ability to hire, 

dismiss, or set the compensation level 

for third party conformity assessment 

body personnel, regardless of whether 

this ability is ever exercised; 

(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 


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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 

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) of this section, 

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 of the 

third party conformity assessment body; 

(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 whose accreditation 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; 


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(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 

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 paragraph (a)(2)(i) 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), ‘‘General requirements 

for the competence of testing and 

calibration laboratories,’’ Second 

Edition, May 15, 2005 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/home.htm. 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 

or test method? 

(a) Once the CPSC publishes the 

requirements for accreditation to a 

particular CPSC rule or test method, a 

third party conformity assessment body 

may apply to the CPSC for acceptance 


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to that scope of accreditation. An 

application may be made for acceptance 

of accreditation to more than one CPSC 

rule 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 the 

requirements for accreditation for third 

party conformity assessment bodies to 

assess conformity for the following 

CPSC rules 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; 

(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 Bed Rails; 

(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; 

(ii) CPSC Standard Operating 

Procedure for Determining Lead (Pb) in 

Paint and Other Similar Surface 

Coatings, CPSC–CH–E1003–09.1; 

(iii) ASTM F2853–10, ‘‘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)’’; 

(ii) 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)’’; 

(iii) CPSC Test Method CPSC–CH– 

E1001–08.2, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry)’’; 

(iv) CPSC Test Method CPSC–CH– 

E1001–08.3, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry)’’; 

(v) 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,’’ 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: 

(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)’’; 

(ii) 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)’’; 

(iii) CPSC Test Method CPSC–CH– 

E1001–08.2, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry)’’; 

(iv) CPSC Test Method CPSC–CH– 

E1001–08.3, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Children’s Metal Products 

(Including Children’s Metal Jewelry)’’; 

(30) Limits on Total Lead in 

Children’s Products: Nonmetal 

Children’s Products. For its 

accreditation to be accepted by the 

Commission to test for lead content in 

nonmetal 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: 

(i) CPSC Test Method CPSC–CH– 

E1002–08, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Nonmetal Children’s Products’’; 

(ii) CPSC Test Method CPSC–CH– 

E1002–08.1, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Nonmetal Children’s Products’’; 

(iii) CPSC Test Method CPSC–CH– 

E1002–08.2, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Nonmetal Children’s Products’’; 

(iv) CPSC Test Method CPSC–CH– 

E1002–08.3, ‘‘Standard Operating 

Procedure for Determining Total Lead 

(Pb) in Nonmetal Children’s Products’’; 

(31) Limits on Phthalates in 

Children’s Toys and Child Care Articles. 

For its accreditation to be accepted by 


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Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 15863 

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’’; 

(ii) GB/T 22048–2008, ‘‘Toys and 

Children’s Products—Determination of 

Phthalate Plasticizers in Polyvinyl 

Chloride Plastic’’; 

(32) ASTM F963–11 ‘‘Standard 

Consumer Safety Specification for Toy 

Safety,’’ and section 4.27 (toy chests) 

from ASTM F963–07e1 ‘‘Standard 

Consumer Safety Specification for Toy 

Safety.’’ The CPSC only requires certain 

provisions of ASTM F963–11 and 

Section 4.27 of ASTM F963–07e1 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 F963–07e1; Section 4.27— 

Toy Chests (except labeling and/or 

instructional literature requirements); 

(ii) ASTM F963–11: 

(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) 

(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 paragraph (b) of 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 International, 100 Bar 

Harbor Drive, P.O. Box 0700, West 

Conshohocken, PA 19428: http:// 

www.astm.org. 

(i) ASTM F2853–10, ‘‘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,’’ July 1, 2010; 

(ii) ASTM F963–07e1, ‘‘Standard 

Consumer Safety Specification for Toy 

Safety,’’ March 15, 2007; 

(iii) ASTM F963–11, ‘‘Standard 

Consumer Safety Specification for Toy 

Safety,’’ December 1, 2011. 

(2) Code of China, Room 2118, New 

Fortune International Plaza, No.71 

Chaoyang Road, Chaoyang District, 

Beijing, 100123, China: http:// 

www.codeofchina.com/. 

(i) GB/T 22048–2008, National 

Standard of the People’s Republic of 

China, ‘‘Toys and Children’s Products— 

Determination of Phthalate Plasticizers 

in Polyvinyl Chloride Plastic,’’ June 18, 

2008; 

(ii) [Reserved] 

(3) CPSC National Product Testing 

and Evaluation Center, 5 Research 

Place, Rockville, MD 20850; 

www.cpsc.gov. 

(i) CPSC–CH–C1001–09.3, ‘‘Standard 

Operating Procedure for Determination 

of Phthalates’’, April 1, 2010; 

(ii) CPSC–CH–E1001–08, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Children’s Metal 

Products (Including Children’s Metal 

Jewelry)’’, December 4, 2008; 

(iii) CPSC–CH–E1001–08.1, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Children’s Metal 

Products (Including Children’s Metal 

Jewelry), Revision’’, June 21, 2010; 

(iv) CPSC–CH–E1001–08.2, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Children’s Metal 

Products (Including Children’s Metal 

Jewelry), Revision’’, April 10, 2012; 

(v) CPSC–CH–E1001–08.3, ‘‘Standard 

Operating Procedure for Determining 

Total Lead (Pb) in Children’s Metal 

Products (Including Children’s Metal 

Jewelry) Revision’’, November 15, 2012; 

(vi) CPSC–CH–E1002–08, ‘‘Standard 

Operating Procedure for Determining 

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

Products’’, February 1, 2009; 

(vii) CPSC–CH–E1002–08.1, 

‘‘Standard Operating Procedure for 

Determining Total Lead (Pb) in Nonmetal Children’s Products, Revised’’, 

June 21, 2010; 

(viii) CPSC–CH–E1002–08.2, 

‘‘Standard Operating Procedure for 

Determining Total Lead (Pb) in 

Nonmetal Children’s Products, 

Revision’’, April 10, 2012; 

(ix) CPSC–CH–E1002–08.3, ‘‘Standard 

Operating Procedure for Determining 

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

Products, Revision’’, November 15, 

2012; 

(x) CPSC–CH–E1003–09, ‘‘Standard 

Operating Procedure for Determining 

Lead (Pb) in Paint and Other Similar 

Surface Coatings’’, April 26, 2009; 

(xi) CPSC–CH–E1003–09.1, ‘‘Standard 

Operating Procedure for Determining 

Lead (Pb) in Paint and Other Similar 

Surface Coatings’’, February 25, 2011; 


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15864 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 

(xii) CPSC ‘‘Standard Operating 

Procedure for Determining Lead (Pb) 

and its Availability in Children’s Metal 

Jewelry’’, February 3, 2005. 

§ 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 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. The CPSC will also list the 

firewalled or governmental status of 

accepted laboratories on the CPSC Web 

site. 

§ 1112.21 May a third party conformity 

assessment body use testing methods 

other than those specified in the relevant 

CPSC rule 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 whose accreditation has 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 available upon 

request by CPSC. 

(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 

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 

electronically, such as through an 

Internet Web site. 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; 


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(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 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. Add 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 

accordance with § 1112.53. 

§ 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(E) 

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. 

§ 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. 


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§ 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. 

§ 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. 

(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 

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 why 

the CPSC should not pursue the 

proposed adverse action, or any portion 


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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 its 

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, 

and must be 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. 

(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 

be issued. 

(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, 

and must be 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. 

(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/ 


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15868 Federal Register / Vol. 78, No. 48 / Tuesday, March 12, 2013 / Rules and Regulations 

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, 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, 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) Are 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 

(iii) Information, both oral and 

written, concerning any matter referred 

to in the Act and these rules. 

* * * * * 

Dated: February 25, 2013. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2013–04649 Filed 3–11–13; 8:45 am] 

BILLING CODE 6355–01–P 


srobinson on DSK4SPTVN1PROD with RULES2