```

[Federal Register Volume 78, Number 48 (Tuesday, March 12, 2013)]
[Rules and Regulations]
[Pages 15835-15868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04649]

[[Page 15835]]

Vol. 78

Tuesday,

No. 48

March 12, 2013

Part III

 Consumer Product Safety Commission

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16 CFR Parts 1112 and 1118

 Requirements Pertaining to Third Party Conformity Assessment Bodies; 
Final Rule

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

[[Page 15836]]

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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.

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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

[[Page 15837]]

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 mm\2\) 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.
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    \1\ An aliquot in chemistry is a portion of a sample.
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    (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.

    \2\ HHXRF 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.
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    The commenter adds that even though other types of XRF 
spectrometers that

[[Page 15838]]

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 Sec.  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 Sec.  
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 Sec.  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 Sec.  1112.15(b)(28), 
although it was intended that the test method be allowed. Therefore, in 
the final rule, Sec.  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 cm\2\, 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 cm\2\ 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 X-ray 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

[[Page 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

[[Page 15840]]

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 Sec.  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

[[Page 15841]]

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 case-by-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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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 Sec.  1112.43 of the rule is considered 
material. If any of the information described in Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  1112.47(b) of the 
proposed rule (unchanged in the final

[[Page 15842]]

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 Sec.  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 Sec.  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 Sec.  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/Business-Manufacturing/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 
CPSC-accepted 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 state-funded 
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 Sec.  
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 Sec.  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 Sec.  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 Sec.  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

[[Page 15843]]

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 Sec.  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 Sec.  1112.49 would be investigated under the 
procedures described in Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec. Sec.  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, Sec.  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

[[Page 15844]]

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 Sec.  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 Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  
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 Sec.  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 Sec.  
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 Sec. Sec.  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.''

[[Page 15845]]

    (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 (Sec.  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 Sec.  1112.1 of the final rule is unchanged from the 
proposed rule, with the following exception. Proposed Sec.  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 Sec.  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 (Sec.  1112.1)
a. Definitions Amending the Audit Rule
    Proposed Sec.  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 Sec.  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

[[Page 15846]]

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? 
(Sec.  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 Sec. Sec.  
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 Sec. Sec.  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 Sec.  
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

[[Page 15847]]

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, Sec.  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 
(Sec.  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 
(Sec.  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 (Sec.  
1112.11(c)(3));
     If any of the laboratory's management or technical 
personnel are government employees (Sec.  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 (Sec.  
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 
(Sec.  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? (Sec.  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

[[Page 15848]]

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 Sec.  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 Sec.  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, Sec.  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? (Sec.  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

[[Page 15849]]

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 Sec.  1112.15(b), as proposed, with the following 
exceptions.
    The preamble to the proposed rule (77 FR at 31135) noted that 
proposed Sec. Sec.  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 Sec.  1112.15(b)(28). In the codified 
text of proposed Sec.  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 Sec.  1112.15(b)(28). Therefore, Sec.  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 Sec. Sec.  
1112.15(b)(28), (29), and (30) of the final rule. In Sec. Sec.  
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 Sec.  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, Sec. Sec.  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 Sec.  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:
    [cir] 16 CFR part 1221, Play Yards (published August 29, 2012);
    [cir] 16 CFR part 1223, Infant Swings (published November 7, 2012); 
and/or
    [cir] 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

[[Page 15850]]

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? (Sec.  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? (Sec.  1112.19)
    In accordance with section 14(a)(3)(E) of the CPSA, Sec.  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.

[[Page 15851]]

6. May a third party conformity assessment body use testing methods 
other than those specified in the relevant cpsc rule or test method? 
(Sec.  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 CPSC-accepted 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? 
(Sec.  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? (Sec.  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 Sec.  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 CPSC-accepted 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 Sec.  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 Sec.  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 
Sec.  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? (Sec.  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 CPSC-acceptance 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 Sec.  1112.45. The preamble to the 
proposed rule discusses this condition of CPSC-acceptance in further 
detail. See 77 FR at 31118.
10. How does a third party conformity assessment body voluntarily 
discontinue its participation with the CPSC? (Sec.  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 CPSC-accepted 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

[[Page 15852]]

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? (Sec.  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 Sec.  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 Sec.  
1112.35(b)(1). If the laboratory also intends to satisfy the audit 
requirement of Sec.  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? (Sec.  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 Sec.  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? (Sec.  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 Sec.  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 Sec.  1112.51 of this part.
3. What are the grounds for suspension of CPSC acceptance? (Sec.  
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 Sec.  
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 Sec.  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? (Sec.  
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,

[[Page 15853]]

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? (Sec.  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? (Sec.  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 Sec.  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 
Sec.  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 Sec.  
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 Sec.  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

[[Page 15854]]

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 Sec.  
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 Sec.  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 Sec.  
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 CPSC-accepted 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 Sec.  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; Sec.  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? (Sec.  
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 
Sec.  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 Sec.  1112.51 apply, except that 
instead of the time frames described in Sec.  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

[[Page 15855]]

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 Sec.  1112.51, an investigation under 
Sec.  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? (Sec.  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 Sec.  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 Sec.  1118.2(a) with the statutory language in section 16(a) of 
the CPSA and the inspection provision at Sec.  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 Sec.  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 Sec.  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.
---------------------------------------------------------------------------

    \3\ The 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.
---------------------------------------------------------------------------

    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.

[[Page 15856]]

    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 Sec.  
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 Sec.  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 Sec.  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 Sec. Sec.  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

[[Page 15857]]

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

[[Page 15858]]

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

0
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.

0
2. Add Sec.  1112.1 to read as follows:

Sec.  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 CPSC-accepted 
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.

0
3. Amend Sec.  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:

Sec.  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 Sec.  1112.13(a), the documents required of 
firewalled applicants in Sec.  1112.13(b)(2), and/or the documents 
required of governmental applicants in Sec.  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.

[[Page 15859]]

    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.

0
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

Sec.  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.

Sec.  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

[[Page 15860]]

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 Sec.  1112.17(b).
    (2) For the Commission to evaluate whether an applicant firewalled 
third party conformity assessment body satisfies the criteria listed in 
Sec.  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;

[[Page 15861]]

    (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 state-owned 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 CPSC-accepted 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 
Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland; Telephone 
+41 22 749 01 11, Fax +41 22 733 34 30; http://www.iso.org/iso/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.

Sec.  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

[[Page 15862]]

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 Lead-Containing 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

[[Page 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 F963-07[egr]1 
``Standard Consumer Safety Specification for Toy Safety.'' The CPSC 
only requires certain provisions of ASTM F963-11 and Section 4.27 of 
ASTM F963-07[egr]1 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 F963-07[egr]1; 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, Hemispheric-Shaped 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 F963-07[egr]1, ``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 Non-metal 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;

[[Page 15864]]

    (xii) CPSC ``Standard Operating Procedure for Determining Lead (Pb) 
and its Availability in Children's Metal Jewelry'', February 3, 2005.

Sec.  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.

Sec.  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.

Sec.  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.

Sec.  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.

Sec.  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.

Sec.  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 Sec.  1112.45.

Sec.  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 CPSC-accepted 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;

[[Page 15865]]

    (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.

0
5. Amend Sec.  1112.35 by adding paragraph (b) to read as follows:

Sec.  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 Sec.  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.

0
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

Sec.  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 Sec.  1112.53.

Sec.  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 Sec.  
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 Sec.  1112.51.

Sec.  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 Sec.  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 Sec.  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.

[[Page 15866]]

Sec.  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.

Sec.  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.

Sec.  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 Sec.  1112.45.
    (5) The notice sent by the CPSC under Sec.  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 Sec.  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 Sec.  1112.53, a CPSC-accepted 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

[[Page 15867]]

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 Sec.  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 CPSC-accepted 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.

Sec.  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 Sec.  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/

[[Page 15868]]

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 Sec.  1112.51 
apply, except that instead of the timeframes described in Sec.  
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 Sec.  
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 Sec.  
1112.51, an investigation under Sec.  1112.51(a) will be launched based 
on the same information that justified the immediate and temporary 
withdrawal.

Sec.  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

0
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.

0
8. Amend Sec.  1118.2 by revising paragraph (a) to read as follows:

Sec.  1118.2  Conduct and scope of inspections.

    (a) After an inspection is initiated as set forth in Sec.  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 Sec.  
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
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