Federal Register, Volume 77 Issue 101 (Thursday, May 24, 2012)

[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Proposed Rules]
[Pages 31086-31141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10923]

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

[[Page 31086]]

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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: Notice of proposed rulemaking.

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

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

ADDRESSES: Comments related to the Paperwork Reduction Act aspects of
the instructional literature and marking requirements of the proposed
rule should be directed to the Office of Information and Regulatory
Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to
oira_submission@omb.eop.gov. You may submit comments, identified by
Docket No. CPSC-2012-0026 by either of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. To ensure timely
processing of comments, the Commission is no longer accepting comments
submitted by electronic mail (email) except through http://www.regulations.gov.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions) preferably in five copies, to: Office of the Secretary,
U.S. Consumer Product Safety Commission, Room 820, 4330 East West
Highway, Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this notice. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
(such as a Social Security Number) electronically; if furnished at all,
such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.

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

SUPPLEMENTARY INFORMATION:

I. Background: Statutory Provisions

Section 14(a)(1) of the CPSA (15 U.S.C. 2063(a)(1)), as amended by
the CPSIA (Pub. L. 110-314, 122 Stat. 3016), requires that the
manufacturer and the private labeler, if any, of a product that is
subject to an applicable consumer product safety rule under the CPSA,
or any similar rule, ban, standard, or regulation under any other Act
enforced by the CPSC, issue a General Conformity Certificate. The
General Conformity Certificate certifies ``based on a test of each
product or upon a reasonable testing program, that such product
complies with all rules, bans, standards, or regulations applicable to
the product under this Act or any other Act enforced by the
Commission,'' and it specifies each rule, ban, standard, or regulation
applicable to the product. 15 U.S.C. 2063(a)(1)(A).
Section 14(a)(2) of the CPSA states that, for any children's
product that is subject to a children's product safety rule, every
manufacturer of such children's product (and the private labeler if the
children's product bears a private label) shall submit sufficient
samples of the product, or samples that are identical in all material
respects to the product, to an accredited third party conformity
assessment body (or, ``laboratory'') to be tested for compliance with
such children's product safety rule. Section 14(a)(2)(B) of the CPSA
requires the manufacturer or private labeler, based on such testing, to
issue a certificate (``Children's Product Certificate'') certifying
that such product complies with the children's product safety rule.
Section 14(h) of the CPSA clarifies that, irrespective of
certification, the product in question must actually comply with all
applicable rules, regulations, standards, or bans enforced by the CPSC.
Section 14(a)(3) of the CPSA establishes various timelines for
accreditation of the laboratories that may conduct third party tests of
children's products and requires the Commission to publish ``a notice
of the requirements for accreditation of third party conformity
assessment bodies to assess conformity'' with specific laws or
regulations. Under section 14(a)(3)(A) of the CPSA, the requirement for
a manufacturer or private labeler of a children's product subject to a
children's product safety rule to issue a certificate based on third
party testing does not commence until ``more than 90 days'' after the
Commission publishes a notice of requirements pertaining to the
regulation or standard to which the children's product is subject.
The Commission has published several notices of requirements in the
Federal Register. See, e.g., 73 FR 54564 (September 22, 2008) (Notice
of Requirements for Accreditation of Third Party Conformity Assessment
Bodies to Assess Conformity with Part 1303 of Title 16, Code of Federal
Regulations); 74 FR 45428 (September 2, 2009) (Notice of Requirements
for Accreditation of Third Party Conformity Assessment Bodies to Assess
Conformity with Parts 1203, 1510, 1512, and/or 1513 and Sec.
1500.86(a)(7) and/or (a)(8) of Title 16, Code of Federal Regulations);
75 FR 70911 (November 19, 2010) (Third Party Testing for Certain
Children's Products; Children's Sleepwear, Sizes 0 Through 6X and 7
Through 14: Requirements for Accreditation of Third Party Conformity
Assessment Bodies). We invited public comment on most, but not all,
notices of requirements. In section III of this preamble, we summarize
and respond to those comments. Section 14(a)(3)(C) of the CPSA provides
that the Commission may either accredit laboratories itself or may
designate an independent accreditation organization to conduct the
accreditations. Section 14(a)(3)(E) of the CPSA requires that the
Commission maintain on its Web site an up-to-date list of entities that
have been accredited to assess conformity with children's product
safety rules.
Section 14(i)(1) of the CPSA requires the Commission to establish
``requirements for the periodic audit of third party conformity
assessment bodies as a condition for the continuing accreditation of
such conformity assessment bodies'' under section

[[Page 31087]]

14(a)(3)(C) of the CPSA. Section 14(e) of the CPSA addresses Commission
withdrawal and suspension of the accreditation (or its acceptance of
the accreditation) of a laboratory.
Section 14(f)(2)(A) of the CPSA defines a ``third party conformity
assessment body'' to mean a conformity assessment body that is not
owned, managed, or controlled by the manufacturer or private labeler of
a product assessed by the laboratory, unless such a laboratory has
satisfied certain statutory criteria. Section 14(f)(2)(D) of the CPSA
provides that a laboratory owned, managed, or controlled by a
manufacturer or private labeler may be accepted by the Commission if
the Commission makes certain findings, by order, concerning the
laboratory's protections against undue influence by the manufacturer,
private labeler, or other interested parties. In that case the
laboratory is considered ``firewalled.'' Similarly, section 14(f)(2)(B)
of the CPSA lists five criteria that a conformity assessment body owned
or controlled in whole or in part by a government (or ``governmental
laboratory'') must satisfy for its accreditation to be accepted by the
CPSC.
This proposed rule, if finalized, would establish the requirements
related to CPSC acceptance of the accreditation of a laboratory for
purposes of testing children's products under section 14 of the CPSA.
The proposed requirements would be largely the same as the requirements
that the CPSC has been using since the CPSIA's passage in August 2008.
Among other things, the proposed rule also would delineate how a
laboratory may voluntarily discontinue its participation with the CPSC,
and it would establish the procedures for the suspension and/or
withdrawal of CPSC acceptance of the accreditation of a laboratory.
This proposed rule also would amend our rule titled, ``Audit
Requirements for Third Party Conformity Assessment Bodies'' (``audit
final rule''), which implements section 14(i)(1) of the CPSA, and is
published elsewhere in this issue of the Federal Register. Finally, the
proposed rule would make particular conforming amendments to 16 CFR
1118.2(a).

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

We published 19 notices of requirements between August 14, 2008 and
August 14, 2011.
The notices of requirements established the criteria and process
for CPSC acceptance of accreditation of laboratories for testing
children's products under section 14 of the CPSA. Each notice of
requirements was specific to particular CPSC rules, bans, standards, or
regulations, and/or it was specific to a standard established by the
CPSIA. We have published the following notices of requirements:
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With Part 1303 of Title 16, Code
of Federal Regulations, 73 FR 54564 (Sept. 22, 2008).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With Part 1508, Part 1509, and/
or Part 1511 of Title 16, Code of Federal Regulations, 73 FR 62965
(Oct. 22, 2008).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With Part 1501 of Title 16, Code
of Federal Regulations, 73 FR 67838 (Nov. 17, 2008).
Accreditation Requirements for Third Party Conformity
Assessment Bodies to Test to the Requirements for Lead Content in
Children's Metal Jewelry as Established by the Consumer Product Safety
Improvement Act of 2008, 73 FR 78331 (Dec. 22, 2008).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With Parts 1203, 1510, 1512,
and/or 1513 and Section 1500.86(a)(7) and/or (a)(8) of Title 16, Code
of Federal Regulations, 74 FR 45428 (Sept. 2, 2009).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With the Limits on Total Lead in
Children's Products, 74 FR 55820 (Oct. 29, 2009).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With Part 1505 and/or Sec.
1500.86(a)(5) of Title 16, Code of Federal Regulations, 75 FR 22746
(April 30, 2010).
Third Party Testing for Certain Children's Products;
Infant Bath Seats: Requirements for Accreditation of Third Party
Conformity, 75 FR 31688 (June 4, 2010); correction, 75 FR 33683 (June
15, 2010).
Third Party Testing for Certain Children's Products;
Infant Walkers: Requirements for Accreditation of Third Party
Conformity Assessment Bodies, 75 FR 35282 (June 21, 2010).
Third Party Testing for Certain Children's Products;
Carpets and Rugs: Requirements for Accreditation of Third Party
Conformity Assessment Bodies, 75 FR 42315 (July 21, 2010).
Third Party Testing for Certain Children's Products; Vinyl
Plastic Film: Requirements for Accreditation of Third Party Conformity
Assessment Bodies, 75 FR 42311 (July 21, 2010).
Third Party Testing for Certain Children's Products;
Mattresses, Mattress Pads, and/or Mattress Sets: Requirements for
Accreditation of Third Party Conformity Assessment Bodies, 75 FR 51020
(Aug. 18, 2010).
Third Party Testing for Certain Children's Products;
Clothing Textiles: Requirements for Accreditation of Third Party
Conformity Assessment Bodies, 75 FR 51016 (Aug. 18, 2010).
Third Party Testing for Certain Children's Products; Youth
All-Terrain Vehicles: Requirements for Accreditation of Third Party
Conformity Assessment Bodies, 75 FR 52616 (Aug. 27, 2010).
Third Party Testing for Certain Children's Products;
Children's Sleepwear, Sizes 0 Through 6X and 7 Through 14: Requirements
for Accreditation of Third Party Conformity Assessment Bodies, 75 FR
70911 (Nov. 19, 2010).
Third Party Testing for Certain Children's Products; Full-
Size Baby Cribs and Non-Full-Size Baby Cribs: Requirements for
Accreditation of Third Party Conformity Assessment Bodies, 75 FR 81789
(Dec. 28, 2010).
Third Party Testing for Certain Children's Products;
Toddler Beds: Requirements for Accreditation of Third Party Conformity
Assessment Bodies, 76 FR 22030 (April 20, 2011).
Third Party Testing for Certain Children's Products; Toys:
Requirements for Accreditation of Third Party Conformity Assessment
Bodies, 76 FR 46598 (Aug. 3, 2011).
Third Party Testing for Certain Children's Products;
Notice of Requirements for Accreditation of Third Party Conformity
Assessment Bodies to Assess Conformity With the Limits on Phthalates in
Children's Toys and Child Care Articles, 76 FR 49286 (Aug. 10, 2011).
The notices of requirements explained the three types of third
party conformity assessment bodies contemplated by section 14 of the
CPSA: (1) Third party conformity assessment bodies that are not owned,
managed, or controlled by a manufacturer or private labeler of a
children's product to be tested by the

[[Page 31088]]

third party conformity assessment body for certification purposes
(``independent'' laboratories); (2) ``firewalled'' conformity
assessment bodies (those that are owned, managed, or controlled by a
manufacturer or private labeler of the children's product); and (3)
third party conformity assessment bodies owned or controlled, in whole
or in part, by a government (``governmental laboratories'').
The notices of requirements have stated that, for a third party
conformity assessment body to be accredited to test children's products
under section 14 of the CPSA, it must be accredited to the
International Organization for Standardization (ISO)/International
Electrotechnical Commission (IEC) Standard 17025:2005, ``General
requirements for the competence of testing and calibration
laboratories.'' The accreditation must be by an accreditation body that
is a signatory to the International Laboratory Accreditation
Cooperation--Mutual Recognition Arrangement (ILAC-MRA). A listing of
ILAC-MRA signatory accreditation bodies is available on the Internet
at: http://ilac.org/membersbycategory.html. The scope of the
laboratory's accreditation must include testing to a specific
regulation or test method that has been the subject of a notice of
requirements.
(A description of the history and content of the ILAC-MRA approach
and of the requirements of the ISO/IEC 17025:2005 laboratory
accreditation standard is provided in the CPSC staff briefing
memorandum, ``Third Party Conformity Assessment Body Accreditation
Requirements for Testing Compliance with 16 CFR Part 1501 (Small Parts
Regulations),'' dated November 2008, and available on the CPSC's Web
site at: http://www.cpsc.gov/library/foia/foia09/brief/smallparts.pdf.)
The notices of requirements have stated that the CPSC maintains on
its Web site an up-to-date listing of laboratories whose accreditation
it has accepted, and the scope of each accreditation. Once we add a
laboratory to that list, the laboratory may begin testing children's
products to any test method or regulation included in the laboratory's
scope of accreditation on the CPSC list, to support a Children's
Product Certificate.
In addition to the baseline accreditation requirements, the notices
of requirements have provided that firewalled laboratories must submit
to the CPSC, copies, in English, of their training documents, showing
how employees are trained that they may notify the CPSC immediately of
any attempt by the manufacturer, private labeler, or other interested
party to hide or exert undue influence over the laboratory's test
results. Employees also must be trained that their report of alleged
undue influence may be reported to the CPSC confidentially. (The
notices of requirements stated that firewalled applicants must submit
``training documents showing how employees are trained to notify the
CPSC immediately and confidentially of any attempt * * * to hide or
exert undue influence.'' To be more consistent with the statute, we are
hereby describing this requirement as a need for the firewalled
applicant to train employees that they may notify the CPSC immediately,
and that a report to the CPSC may be confidential. The laboratory must
have established procedures to ensure that an employee may report an
allegation of undue influence to the CPSC and may do so confidentially.
See 15 U.S.C. 2063(f)(2)(D)(ii)(III). Submission of training documents
evidencing such policies is required. Additionally, the statute imposes
a duty on the laboratory to have procedures in place to ensure that the
CPSC is notified immediately of any attempt at undue influence, see 15
U.S.C. 2063(f)(2)(D)(ii). However, we do not interpret the statute as
requiring an individual employee to contact the CPSC. Accordingly, the
change in phrasing increases consistency with the statute.) These
additional requirements have applied to any laboratory in which a
manufacturer or private labeler of a children's product to be tested by
the laboratory owns an interest of 10 percent or more.
With regard to governmental laboratories, the notices of
requirements have reiterated the five criteria from section 14(f)(2)(B)
of the CPSA that must be satisfied for the CPSC to accept the
accreditation of a governmental laboratory:
To the extent practicable, manufacturers or private
labelers located in any nation are permitted to choose conformity
assessment bodies that are not owned or controlled by the government of
that nation;
The third party conformity assessment body's testing
results are not subject to undue influence by any other person,
including another governmental entity;
The third party conformity assessment body is not accorded
more favorable treatment than other third party conformity assessment
bodies in the same nation whose accreditation has been accepted by the
CPSC;
The third party conformity assessment body's testing
results are accorded no greater weight by other governmental
authorities than those of other third party conformity assessment
bodies whose accreditation has been accepted by the CPSC; and
The third party conformity assessment body does not
exercise undue influence over other governmental authorities on matters
affecting its operations or on decisions by other governmental
authorities controlling distribution of products based on outcomes of
the third party conformity assessment body's conformity assessments.
The notices of requirements have explained that CPSC staff will
engage the governmental entities relevant to the accreditation request
to obtain assurances that the statutory criteria are satisfied.
The notices of requirements also have explained that we have
established an electronic accreditation acceptance and registration
system accessed via the CPSC's Web site site at: http://www.cpsc.gov/about/cpsia/labaccred.html. CPSC Form 223, the application form for
laboratories seeking CPSC acceptance of their accreditation, may be
accessed, completed, and submitted online. The applicant must provide,
in English, basic identifying information concerning its location, the
type of accreditation it is seeking, electronic copies of its
certificate and scope statement from an ILAC-MRA signatory
accreditation body, and firewalled laboratory training document(s), if
relevant.
As explained in the notices of requirements, CPSC staff reviews the
submission for accuracy and completeness. In the case of independent
and governmental laboratories, when that review and any necessary
discussions with the applicant are completed, we will add any accepted
laboratory to the CPSC's list of accepted laboratories. This list can
be found at: http://www.cpsc.gov/cgi-bin/labsearch. In the case of a
firewalled laboratory, when CPSC staff's review is complete, CPSC staff
transmits its recommendation on acceptance of accreditation to the
Commission (meaning, in this instance, the Commissioners) for
consideration. If the Commission accepts a CPSC staff recommendation to
accept the accreditation of a firewalled laboratory, we will add the
firewalled laboratory to the CPSC's list of accepted laboratories. In
each case, we notify the laboratory electronically of our acceptance of
its accreditation.
The notices of requirements have become effective on publication,
meaning that as soon as the notices of

[[Page 31089]]

requirements publish, laboratories could apply to the CPSC for
acceptance of their accreditation. In most cases, the requirement for a
manufacturer or private labeler of a children's product subject to a
children's product safety rule to issue a certificate of compliance,
based on third party testing with that rule, commences for products
manufactured more than 90 days after publication of the notice of
requirements that pertains to that rule.
In most cases, the standard or test method specified in a notice of
requirements was either already in effect, or became effective upon
publication of the notice of requirements. (There were four notices of
requirements that published the same day as a final rule establishing
the safety standard specified in the notice: the notices of
requirements for infant bath seats, infant walkers, cribs, and toddler
beds. In those cases, the safety standard took effect six months after
publication. See 75 FR 31688 (June 4, 2010), correction, 75 FR 33683
(June 15, 2010); 75 FR 35282 (June 21, 2010); 75 FR 81789 (Dec. 28,
2010); 76 FR 22030 (Apr. 20, 2011)). Our approach to third party
conformity assessment uses and builds upon existing systems of
conformity assessment, based on ISO/IEC standards and internationally
recognized accreditation bodies. Some manufacturers of children's
products subject to children's product safety rules have put in place
their own processes for third party testing to demonstrate conformity
with certain mandatory and voluntary safety standards. As we were
publishing the notices of requirements, we were aware that some
manufacturers may already have been testing their products at
laboratories that were accredited by an ILAC-MRA signatory
accreditation body in accordance with ISO/IEC 17025:2005. Thus, it was
possible that when a particular notice of requirements published, some
products in the marketplace had already undergone testing (i.e.,
earlier than the mandatory effective date of third party testing) in a
way that would support certification with the respective children's
product safety rule(s). Therefore, most notices of requirements
included provisions allowing Children's Product Certificates to be
based on testing performed by a ISO/IEC 17025:2005-accredited
laboratory prior to the CPSC's acceptance of its accreditation. This
practice is sometimes referred to as allowing ``retrospective''
testing. In the notices of requirements, we prescribed particular
circumstances under which retrospective testing could support a
Children's Product Certificate. For example, we required that the
product be tested by a laboratory that was, at the time of product
testing, accredited to ISO/IEC 17025:2005 by an ILAC-MRA signatory; the
accreditation scope in effect at the time of testing had to include
testing to the regulation or test method identified in the notice; and
we placed constraints on how far back in time the retrospective testing
could have occurred. In several of the initial notices of requirements,
we did not allow any retrospective testing by firewalled laboratories.
Later, we allowed retrospective testing by firewalled laboratories if
the firewalled laboratory had already been accepted by an order of the
Commission for testing to a children's product safety rule specified in
an earlier notice of requirements.

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

The Commission has established requirements for accreditation of
third party conformity assessment bodies (``laboratories'') for certain
children's product safety rules in accordance with section 102(a)(2) of
the CPSIA. Most notices of requirements provided an opportunity for
public comment. Below, we describe and respond to the comments
submitted in response to the notices of requirements that published
before August 14, 2011. As of August 14, 2011, 17 notices of
requirements have been published in the Federal Register. Table 1 lists
the notices of requirements.

Table 1--Notices of Requirements Issued With Comments Received
----------------------------------------------------------------------------------------------------------------
Regulation or product(s) Federal Register citation Regulations.gov docket No.
----------------------------------------------------------------------------------------------------------------
Part 1303/Lead Paint.................... 73 FR 54564, (September 22, CPSC-2008-0033.
2008) (Revision notice at 76 FR
18645 (April 5, 2011)).
Parts 1508, 1509, 1511/Full-size cribs, 73 FR 62965, (October 22, 2008). CPSC-2008-0038.
non-full-size cribs, and pacifiers.
Part 1501/Small parts................... 73 FR 67838, (November 17, 2008) CPSC-2008-0050.
Lead content in children's metal jewelry 73 FR 78331 (December 22, 2008). CPSC-2008-0049.
Parts 1203,1510, 1512, 1513, sec. 74 FR 45428, (September 2, 2009) CPSC-2009-0067.
1500.86(a)(7) and (a)(8)/Bicycle
helmets, dive sticks, rattles,
bicycles, and bunk beds.
Total lead in children's (metal and non- 74 FR 55820, (October 29, 2009). CPSC-2009-0090
metal) products.
Part 1505, sec. 75 FR 22746, (April 30, 2009)... CPSC-2010-0035
1500.86(a)(5)Electrically operated toys/
articles and clacker balls.
Part 1215/Infant bath seats............. 75 FR 31688, (June 4, 1020), CPSC-2010-0064.
(Correction notice at 75 FR
33683 (June 15, 2010)).
Part 1216/Infant walkers................ 75 FR 35282, (June 21, 2010).... CPSC-2010-0066.
Part 1611/Vinyl plastic film............ 75 FR 42311 (July 21, 2010)..... CPSC-2010-0079.
Parts 1630 and 1631/Carpets and rugs 75 FR 42315 (July 21, 2010)..... CPSC-2010-0078.
Part 1610/Clothing Textiles............. 75 FR 51016 (August 18, 2010) CPSC-2010-0086.
(Revision notice at 76 FR 22608
(April 22, 2011).
Parts 1632 & 1633/Mattresses, Mattress 75 FR 51020 (August 18, CPSC-2010-0085.
Pads, and Mattress Sets. 2010)Revision notice at 75 FR
72944 (November 29, 2010).
Part 1420/ATVs \1\...................... 75 FR 52616 (August 27, 2010) CPSC-2010-0090.
(Extension notice at 75 FR
76708 (December 9, 2010).
Parts 1615 and 1616/Children's Sleepwear 75 FR 70911 (November 19, 2010). None.
Parts 1219 and 1220/Full-Size Baby Cribs 75 FR 81789 (December 28, 2010). CPSC-2009-0064.
and Non-Full-Size Baby Cribs.
Part 1217/Toddler Beds.................. 76 FR 22030 (April 20, 2011).... CPSC-2009-0064.
ASTM F 963-08, and section 4.27 of ASTM 76 FR 46598 (August 3, 2011).... CPSC-2011-0050.
F 963-07 for toy chests (CPSIA Section
106).

[[Page 31090]]

CPSC-CH-C1001-09.3...................... 76 FR 49286 (August 10, 2011)... CPSC-2011-0052.
----------------------------------------------------------------------------------------------------------------
\1\ We note that recently we published a final rule in the Federal Register, revising 16 CFR part 1420. The
final rule makes American National Standard, ANSI/SVIA-1-2010, the new mandatory standard for ATVs.
Consequently, proposed Sec. 1112.15(b)(9) would refer to the ANSI/SVIA-1-2010 safety standard for all-
terrain vehicles for purposes of our acceptance of laboratory accreditation.

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

A. Comments on Baseline Accreditation Requirements

(Comment 1)--Some commenters supported the use of International
Standards Organization/International Electrotechnical Commission (ISO/
IEC) 17025:2005 standard on testing and calibration laboratories and
the International Laboratory Accreditation Cooperation--Mutual
Recognition Arrangement (ILAC-MRA) because this helps establish an
internationally recognized consortium for organizations qualified to
provide accreditation services. A commenter recommended that the CPSC
conduct periodic reviews and revise the accreditation requirements to
ensure that the highest standards for laboratory accreditation are
being followed. The commenter suggested that if ISO/IEC 17025:2005 is
superseded by a more stringent standard, then the CPSC should adopt the
more stringent standard.
(Response 1)--Section 14(a)(3)(D) of the CPSA states: ``[t]he
Commission shall periodically review and revise the accreditation
requirements established under subparagraph (B) to ensure that the
requirements assure the highest conformity assessment body quality that
is feasible.'' If a new version of ISO/IEC 17025:2005 is adopted by the
ISO, the CPSC will review the new requirements and determine whether
the new version would improve the CPSC's laboratory program. Any change
to the requirements for CPSC-accepted third party conformity assessment
bodies will be pursued as an amendment to 16 CFR part 1112.
(Comment 2)--Multiple commenters suggested that the Commission
consider accepting laboratory accreditation from the National
Environmental Laboratory Accreditation Conference (NELAC). A commenter
noted that NELAC follows the ISO/IEC 17025:2005 standard and is similar
to the American Association of Laboratory Accreditation (A2LA), an
ILAC-MRA signatory accreditation body. The National Environmental
Laboratory Accreditation Program (NELAP) implements the NELAC
standards.
Another commenter recommended that the CPSC accept the
accreditation of laboratories accredited by the American Industrial
Hygiene Association (AIHA), which is accredited to ISO/IEC 17011:2004,
but was not an ILAC-MRA signatory (at the time the comment was
submitted). The AIHA accredits laboratories to ISO/IEC 17025:2005 for
the National Lead Laboratory Accreditation Program (NLLAP),
administered by the U.S. Environmental Protection Agency (EPA). One
commenter stated that, by not including AIHA-accredited laboratories,
there are not a sufficient number of laboratories in the United States
to handle the volume of testing required by the CPSIA. Multiple
commenters recommended that accreditation bodies that are part of the
National Cooperation for Laboratory Accreditation (NACLA) be recognized
by the CPSC, and thus, enable the laboratories accredited by NACLA
members to provide test results for lead in paint that can be used as a
basis of issuing a Children's Product Certificate. The NACLA does not
rely on mutual recognition among accreditation bodies, but it has a
Recognition Council to recognize accreditation bodies. NACLA members
follow the provisions of ISO/IEC 17011:2004 and accredit laboratories
to ISO/IEC 17025:2005.
(Response 2)--In September 2010, AIHA became an ILAC-MRA signatory.
Laboratories accredited by AIHA, after becoming an ILAC-MRA signatory,
may apply for CPSC acceptance of their accreditation. Therefore, the
comment that the Commission should make AIHA a CPSC-designated
accreditation body is moot. Currently, NACLA and NELAC are not
signatories to the ILAC-MRA. NACLA and NELAC are domestic organizations
that do not have recognition arrangements with foreign countries.
The CPSA, as amended by the CPSIA, directs the CPSC to establish
and publish notices of requirements for accreditation of third party
conformity assessment bodies to assess conformity with a children's
product safety rule to which such children's product is subject. The
CPSA provides that accreditation of third party laboratories may be
conducted by the Commission or by an independent accreditation
organization designated by the Commission.
In consideration of the timelines established by the CPSA and the
fact that children's consumer products are manufactured for the U.S.
market in nations throughout the world, we identified several
objectives for a laboratory accreditation program that could accomplish
the implementation of the CPSA. These objectives were:
(1) Designate the core elements of a CPSC accreditation program to
an entity that is established and has acceptance on a multinational
level. The entity should follow internationally recognized standards
for assessing the competence of laboratories and for the processes and
standards used by accreditation bodies that evaluate such laboratories;
(2) Designate one entity that immediately could bring on board, on
a multinational level, the largest number of accreditation bodies that
could begin the process of accrediting laboratories in accordance with
the CPSC specific requirements for a children's product safety rule;
and
(3) Avoid designation to accreditation programs or entities that
are recognized only in a specific region, nation, or locality. The
reasons for this objective are to: (a) Keep the program as simple as
possible for use by manufacturers, private labelers, importers,
laboratories, and other interested parties; (b) avoid any perceived
notions of barriers to fair trade practices; (c) establish a program
that is manageable within agency resources; and (d) maintain a degree
of

[[Page 31091]]

consistency in the procedures used by the designated accreditation
bodies.
The Commission will continue to designate accreditation bodies that
are signatories to the ILAC-MRA. We believe that the laboratory
accreditation requirements approved by the Commission are consistent
with the direction of the CPSA and meet the objectives outlined above.
We recognize that there are other laboratory accreditation
organizations or accreditation bodies. Some of these organizations may
adhere to similar procedures and standards (but with some distinctions)
as those established in the ILAC-MRA signatory program. However,
expanding CPSC designations to such organizations would not meet all of
the objectives outlined above.
Regarding laboratory testing capacity for lead in paint, we are not
aware of any evidence indicating that insufficient CPSC-accepted
laboratory testing capacity for lead in paint exists. If lead in paint
testing capacity becomes an issue in the future, the CPSC will address
the situation.
(Comment 3)--A commenter recommended that laboratories ``be
specifically CPSC accepted based on accreditation which the [ILAC-MRA]
system, on its own, may not ensure.'' The commenter stated that this
would secure the impartiality of certification better. The commenter
opposed limiting accreditation bodies to ILAC-MRA signatories because
there is no reciprocity with ILAC-MRA countries to accept
accreditations from the Occupational Safety and Health Administration
(OSHA), the American National Standards Institute, or the Standards
Council of Canada.
(Response 3)--With regard to the commenter's suggestion that there
are standards or norms which the ILAC-MRA system ``on its own, may not
ensure,'' the commenter did not specify what the ILAC-MRA system fails
to ensure. Accordingly, we are unable to respond meaningfully to that
portion of the comment. As for the impartiality of certification, we
note that the CPSA does not require conformity assessment bodies to
issue certificates. Instead, section 14(a)(2) of the CPSA assigns
responsibility for certifying to ``every manufacturer of [a children's
product subject to a children's product safety rule] (and the private
labeler of such children's product if such children's product bears a
private label).''
The topic of reciprocity is addressed in the response to Comment 7.
(Comment 4)--A commenter responding to the notice of requirements
for accreditation of laboratories to assess conformity with 16 CFR part
1505 (electrically operated toys or other electrically operated
articles intended for use by children) stated that many requirements of
the regulation would not be evaluated by laboratory testing, but
rather, would be evaluated via inspection, auditing, and construction
review. For example, the fulfillment of requirements in Sec. Sec.
1505.3, pertaining to labeling, 1505.4, regarding manufacturing
requirements, and 1505.5, related to electrical design and performance,
generally would not be evaluated by what is commonly understood as
``laboratory testing.'' The commenter suggested using ISO/IEC
17020:1998, General criteria for the operation of various types of
bodies performing inspection, as the accreditation requirements for
these activities. The commenter said that the CPSC could supplement
ISO/IEC 17020:1998 criteria with additional specific requirements for
individuals performing these activities to ensure that individuals
possess engineering education, training, and experience to evaluate
compliance effectively.
(Response 4)--Section 14(a)(2) of the CPSA requires manufacturers
of any children's product subject to a children's product safety rule
to submit the product for third party testing. As structured by the
CPSA, certification of compliance with children's product safety rules
is based on product testing (not manufacturing facility inspection) at
a third party conformity assessment body (laboratory). A third party
conformity assessment body conducts all of the performance tests in the
standard. The portions of the standard, rule, ban, or regulation that
do not use testing are attested to by the manufacturer when it issues a
Children's' Product Certificate for the product.
Inspection, as intended by ISO/IEC 17020:1998, is generally used
for individual items or very small production volumes. Conformity
assessment is used for assuring compliance to established standards and
is applicable to larger production volumes. At this time, we decline to
recommend adopting the suggestion of using ISO/IEC 17020:1998.
(Comment 5)--One commenter urged the Commission to consider third
party certification of products (as opposed to third party testing) by
certification bodies accredited to ISO/IEC 17065, General Requirements
for Bodies Operating Product Certification Systems. The commenter
stated that third party certification includes actions taken by the
certifying body to ensure continuing conformance. The commenter
suggested that requiring third party certification and marking would be
less costly and more effective. The commenter urged the CPSC to
consider the principles of product certification outlined in the
American National Standards Institute (ANSI) document, National
Conformity Assessment Principles for the United States.
Another commenter asked that the CPSC consider alternative criteria
for accreditation to allow for organizations that are accredited to
Standard ISO/IEC 17065.
(Response 5)--With regard to the suggestion that the Commission
consider third party certification of products, section 14(a)(2) of the
CPSA specifically states that samples of the children's product are
submitted to a third party conformity assessment body for testing (not
for certification), and that the manufacturer or private labeler of the
children's product issue the certificate that certifies that the
product complies with the applicable children's product safety rules.
That responsibility cannot be delegated to another party. Thus,
certification of a children's product by a third party certification
body does not meet the requirements of the CPSA.
With regard to the commenter's suggestion that the CPSC consider
including alternative criteria for accreditation to allow CPSC
acceptance of accreditations to ISO/IEC 17065, ISO/IEC 17065 has not
(as of the date of this proposed rule) been finalized. This draft
standard is still in development as a revision to ISO Guide 65:1996,
General Requirements for Bodies Operating Product Certification
Systems. Because ISO/IEC 17065 has not been finalized, we cannot
evaluate whether this standard would meet the requirements of the CPSA.
If we assume that the provisions of ISO Guide 65:1996 are maintained in
ISO/IEC 17065, Sec. 1.2 of ISO Guide 65:1996 states that the
certification system used by the certification body may include one of
more of a list of evaluation techniques. Included in that list are
methods that do not involve testing for compliance to the applicable
children's product safety rules. Section 14(a)(2)(B) of the CPSA
requires Children's Product Certificates to be based on testing.
Because ISO Guide 65:1996 allows for product certification without
testing, certification by organizations that are accredited to ISO
Guide 65:1996 may not include the required testing and cannot be used
for children's product certification purposes.
With regard to the ANSI document, National Conformity Assessment
Principles for the United States, this

[[Page 31092]]

document mirrors many widely-accepted concepts and processes used by
conformity assessment bodies and certification bodies. For example,
provisions in the ANSI document regarding testing competency and
protection of a customer's data are mirrored in ISO/IEC 17025:2005 and
ISO Guide 65:1996. However, the principles in the ANSI document are
more closely related to product certification, and thus, are not
appropriate for laboratories involved in support of children's product
certification by the manufacturer. For example, conformity assessment
principle number 12 in the ANSI document states: ``As appropriate,
conformity assessment bodies undertake reasonable surveillance
procedures to ensure continued product conformity and protection of
their mark.'' Surveillance procedures and certification marks are
activities typically undertaken by certification bodies, not
laboratories conducting tests. Thus, we decline to recommend adopting
the suggestion of using the ANSI document because it relates to
certification activities not undertaken by testing.
(Comment 6)--Some commenters supported the use of ISO/IEC
17025:2005 as an accreditation tool but emphasized the importance of
ensuring that the scope of accreditation applies only to the testing
for which the conformity assessment body has demonstrated competence.
(Response 6)--We agree with the commenters. Every conformity
assessment body applying for CPSC acceptance of their accreditation
must submit a statement of scope that lists explicitly the CPSC
regulation(s) and/or test method(s) for which they are applying.
(Comment 7)--Multiple commenters suggested adopting reciprocity
provisions as a part of laboratory accreditation requirements.
Reciprocity, in this context, means that if the CPSC accepts the
accreditation of foreign laboratories to test consumer products for
compliance to the requirements of section 14 of the CPSA, the host
country of the foreign laboratory must provide similar treatment to
U.S.-based laboratories. Possible reciprocity provisions could include
a statement that, in reviewing a laboratory's application, the CPSC
will take into consideration whether the host country of the applicant
provides similar accreditation for U.S.-based laboratories in their
markets. Another possible reciprocity policy would require that the
countries of non-U.S.-based laboratories that wish for their
accreditation to be accepted by the CPSC, offer recognition to U.S-
based laboratories for that country's certification programs.
One commenter stated that a reciprocity provision would benefit
U.S. manufacturers because reciprocity would allow for streamlined
testing requirements and protocols across international markets and
would also keep manufacturers from sending testing samples to multiple
testing facilities around the world in order to ``shop'' for passing
testing results. Another commenter stated that without reciprocity
provisions, U.S.-based laboratories are damaged by not having access to
other countries' conformity assessment systems. The commenter
recommended that the CPSC amend its proposed accreditation requirements
to include reciprocity provisions identical to those used by OSHA under
its Nationally Recognized Testing Laboratory (NRTL) program.
One commenter stated that, without reciprocity provisions, the
product safety scheme will lack the necessary shared interest in
quality oversight to make it a functioning program.
(Response 7)--We decline to adopt reciprocity as a criterion in the
CPSC third party conformity assessment body program, although we are
aware that the other federal laboratory recognition programs contain
such a provision. At this time, we have not determined that reciprocity
promotes consumer safety. The mission of this agency is to protect the
public against unreasonable risks of injury from consumer products. One
way we accomplish that mission is by implementing the CPSIA's
requirement that products subject to children's product safety rules be
third party tested. Thus, our interest, in this instance, is to
establish an effective and efficient laboratory program through which
we recognize laboratories that are competent to conduct these third
party tests.
As for the comment regarding shared interest in quality oversight,
to the extent that the commenter is suggesting that reciprocity
provisions are necessary for the CPSC's laboratory program to function,
the commenter did not describe how or why having reciprocal testing-
body recognition is necessary to implementing section 14 of the CPSA.
We use accreditation by an ILAC-MRA signatory accreditation body to an
international standard, ISO/IEC 17025:2005, and additional information,
to determine whether to accept the accreditation of an applicant
laboratory. Sections 1.4 and 1.6 of ISO/IEC 17025:2005 specifically
refer to the quality management system of the laboratory. Laboratories
accredited to ISO/IEC 17025:2005 must implement a quality management
system, appoint a staff member as quality manager, and continually
improve the effectiveness of its management system through the use of
quality policy, quality objectives, audit results, and other factors.
None of these quality oversight items requires reciprocity between
nations.

B. Comments on Firewalled/Governmental Laboratories and Undue Influence

(Comment 8)--One commenter stated the belief that validation of a
laboratory's independence is critical to the success of all CPSC safety
initiatives, including program development for third party testing of
children's products. The commenter pointed to OSHA's NRTL program and
ISO Guide 65:1996 as a means to underscore the critical role of
independence. ISO Guide 65:1996 details the requirements of operating
without a conflict of interest and includes several requirements
concerning organizational structure to protect impartiality and to
prevent conflict of interest. The commenter suggested that the
Commission should consider the requirements of Clause 4.2 of ISO Guide
65:1996 and look to OSHA's NRTL program as an example of the level of
inquiry that should be required, the type of requirements that should
be implemented, and to ensure impartiality and prevent conflict of
interest.
The commenter noted that these issues deserve special emphasis for
proprietary (firewalled) and governmental laboratories. Under the
CPSC's laboratory accreditation requirements that were published in the
notices of requirements and that are provided in additional detail in
this proposed rulemaking, firewalled and governmental laboratories are
required to demonstrate particular undue influence safeguards, as
specified in the CPSA, in addition to the requirements of the ISO/IEC
17025:2005 standard.
(Response 8)--The OSHA program and ISO Guide 65:1996 are tailored
to certification bodies/programs and not to laboratories that conduct
tests. Under the structure of third party testing required by the CPSA
(as amended by the CPSIA), product certification elements (certifying
compliance with a CPSC rule) are the responsibility of the manufacturer
or private labeler. The certifying manufacturer or private labeler must
support its certificate of compliance with testing by a CPSC-accepted
laboratory (referred to in the CPSA as third party conformity

[[Page 31093]]

assessment body). There are international standards written
specifically for different areas related to conformity assessment
(e.g., inspection activities, certification programs, laboratories).
Because the CPSA requires the CPSC to establish requirements for
entities that conduct product testing, the CPSC programs require the
ISO/IEC standard that is specifically applicable to testing
laboratories (ISO/IEC 17025:2005). ISO/IEC 17025:2005 has provisions
that require the laboratory to have policies and procedures to avoid
involvement in any activities that would diminish confidence in its
competence, impartiality, judgment, or operational integrity. A third
party laboratory must demonstrate that it is impartial and that its
personnel are free from any undue commercial, financial, and other
pressures that might influence their technical judgment. ILAC-MRA
signatory accreditation bodies assess laboratories to these criteria
during laboratory assessments.
In addition, the CPSA requires that firewalled and governmental
laboratories satisfy certain criteria, which include protections
against undue influence. The CPSC implements those criteria, such that
firewalled and governmental laboratory applicants must submit
additional materials that address undue influence safeguards. For a
full description of the additional application materials, see
discussion of proposed Sec. 1112.13(b) and (c) in section IV, B.2 of
the preamble.
The criteria for safeguards against undue influence are addressed
by the proposed CPSC requirements, and there should not be additional
criteria based on programs or standards that are not specific for
laboratories that conduct tests.
(Comment 9)--One commenter urged the CPSC to ``differentiate
between what are authentic, third party conformity assessment bodies
from manufacturer-owned, firewalled labs.'' The commenter stated that
such differentiation would be consistent with widely used terminology
in the manufacturing communities and would reflect the structure of the
laboratories better.
(Response 9)--We interpret the commenter as addressing our use of
the term ``third party conformity assessment body'' to refer to any of
the three types of laboratories accepted by the CPSC (independent,
firewalled, and governmental). To many in the consumer product
industry, a ``third party conformity assessment body'' corresponds only
to an independent laboratory.
Section 14(f) of the CPSA defines and discusses the term ``third
party conformity assessment body'' to include all three types of
laboratories. Accordingly, the notices of requirements, and this
proposed rule, describe all laboratories whose accreditation has been
accepted by the Commission as ``third party conformity assessment
bodies,'' whether they are independent, governmental, or firewalled.
(Comment 10)--The notices of the requirements for accreditation of
third party conformity assessment bodies require firewalled laboratory
applicants to submit copies of training documents showing how employees
are trained to notify the CPSC immediately and confidentially of any
attempt by the manufacturer, private labeler, or other interested party
to hide or exert undue influence over the third party conformity
assessment body's test results. Some commenters suggested that the
Commission develop standards for these training documents. A commenter
noted that standards for impartiality are addressed in ISO Guide
65:1996, which, as a starting place, could be used for this purpose. A
commenter also suggested that the CPSC, in developing standards for
training documents, consider other standards or best practices that are
protective of laboratory and test result integrity.
(Response 10)--The CPSA includes a provision that requires all
CPSC-accepted firewalled laboratories to establish procedures to ensure
that employees may report immediately and confidentially allegations of
undue influence to the CPSC, 15 U.S.C. 2063(f)(2)(D). The notices of
requirements have required firewalled laboratory applicants to submit
copies, in English, of their training documents showing how employees
are trained on those procedures. This proposed rule would continue that
requirement.
A team of CPSC staff reviews applications from firewalled
laboratories, including the submission of training documents. If the
team concludes that the application materials satisfy the statutory
requirements for acceptance as a firewalled conformity assessment body,
the team recommends the applicant for Commission acceptance. Thus far,
the training documents submitted by firewalled laboratory applicants
have indicated clearly whether section 14(f)(2)(D) of the CPSA has been
satisfied. However, the CPSC will consider this suggestion as we review
future applications from firewalled laboratories. Should we determine
that establishing standards for training documents would be helpful, we
will consider the criteria for impartiality in other standards and best
practices.
We note that accreditation bodies play a role in ensuring
impartiality of firewalled laboratories as well. Section 4.1.5(b) of
ISO/IEC 17025:2005 requires that the laboratory ``have arrangements to
ensure that its management and personnel are free from any undue
internal and external commercial, financial and other pressures and
influences that may adversely affect the quality of their work.'' Note
2 under Sec. 4 of ISO/IEC 17025:2005, Management Requirements, states:

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

The accreditation body evaluates the laboratory regarding this
provision during the initial assessment and during each reassessment.
Thus, the firewalled laboratory's accreditation body also evaluates the
policies and procedures by which the laboratory avoids activities that
would diminish confidence in its impartiality.
To the extent that these commenters also intended to suggest that
the CPSC apply standards to the training documents submitted by
government laboratory applicants, we note that, to date, the CPSC has
not requested that governmental laboratory applicants submit training
documents. Nor are we proposing in this rule that governmental
laboratory applicants submit training documents to the CPSC. Sections
14(f)(2)(D)(ii)(II) and (III) of the CPSA specifically require that
applicants for firewalled status have established procedures to ensure
that, inter alia, the CPSC is notified immediately of any attempt at
undue influence and that allegations of undue influence may be reported
to the CPSC confidentially. To implement those provisions, we require
firewalled applicants to submit training documents so that we can
ensure that these safeguards have been communicated to employees. The
statute does not require governmental laboratories to have established
policies that involve employees notifying the CPSC immediately and
confidentially of an attempt at undue influence. Thus, we are not
requiring training documents from governmental laboratory

[[Page 31094]]

applicants in support of such requirements. Instead, the CPSIA
established five criteria that each governmental applicant must satisfy
to have its accreditation accepted by the CPSC. To implement those
criteria, the proposed rule would require a governmental laboratory
applicant to submit responses to a questionnaire, a description of its
relationship with other entities, an attestation, and the laboratory's
undue influence policy. For more information on those requirements, see
the discussion of proposed Sec. 1112.13(c) in section IV.B.2 of the
preamble.
(Comment 11)--Some commenters recommended that the Commission
establish safeguards to ensure that employees who are engaged in
conformity assessment activities are not rewarded for positive outcomes
of testing.
(Response 11)--We agree that a third party conformity assessment
body should not reward an employee for a ``passing'' test result. The
notices of requirements have required, and this proposed rule would
continue requiring, that CPSC-accepted laboratories be accredited to
the provisions in ISO/IEC 17025:2005 by a signatory to the ILAC-MRA.
Section 4.1.5(b) of ISO/IEC 17025:2005 states that the laboratory shall
``have arrangements to ensure that its management and personnel are
free from any undue internal and external commercial, financial, and
other pressures and influences that may adversely affect the quality of
their work.'' The laboratory's accreditation body checks for
conformance to this section of ISO/IEC 17025:2005 during initial
accreditation and each reassessment. Therefore, we consider the
commenters' suggestion to be addressed already in the ISO/IEC
17025:2005 requirements, and therefore, additional CPSC requirements
are not warranted.
(Comment 12)--One commenter, who responded to several notices of
requirements, suggested that we require applicants, including the
firewalled and governmental laboratories, to submit the evidence used
to validate the fulfillment of Sec. 4.1.5(b) of ISO/IEC 17025:2005, as
part of their application to the CPSC to assure impartiality and avoid
undue influence. The commenter argued that this information is
particularly necessary because the requirements for firewalled
laboratories to submit documents related to staff training on undue
influence ``are not sufficient on their own to pro-actively assure the
Commission about the impartiality of a firewalled (or government)
laboratory.'' The commenter contended that requiring evidence of the
fulfillment of Sec. 4.1.5(b) of ISO/IEC 17025:2005 would drive
accreditation bodies and laboratories to pay more specific attention to
ISO/IEC 17025:2005 Sec. 4.1.5(b); promote consistency; and provide the
CPSC with a means of monitoring compliance.
(Response 12)--We believe that requiring applicants to submit
records used to validate the fulfillment of Sec. 4.1.5(b) of ISO/IEC
17025:2005 to the CPSC is unnecessary. It is the role of the
laboratory's accreditation body to evaluate whether a laboratory
satisfies the requirements of ISO/IEC 17025:2005; it would be
duplicative for the CPSC to perform the same evaluation. Accreditation
bodies have the expertise to evaluate laboratories to all provisions of
ISO/IEC 17025:2005, including Sec. 4.1.5(b).
With regard to the suggestion that, if the CPSC required submission
of the evidence of compliance with Sec. 4.1.5(b) of ISO/IEC
17025:2005, accreditation bodies and laboratories would pay more
specific attention to that requirement, we believe that accreditation
bodies garner significant attention from laboratories. If a laboratory
failed to meet the requirements of ISO/IEC 17025:2005 to the
satisfaction of its accreditation body, the laboratory could lose its
accreditation and a potentially significant portion of its business.
With regard to the suggestion that submission of the records used
to validate fulfillment of ISO/IEC 17025:2005 Sec. 4.1.5(b) would
promote consistency among laboratories, we respond that currently, we
do not perceive any need to do so. The Commission has decided to
designate laboratory accreditation to ILAC-MRA signatories, per section
14(a)(3)(C) of the CPSA. At this time, we are not aware that this
designation has resulted in problems regarding undue influence.
Requiring submission of the records used to validate the fulfillment of
ISO/IEC Sec. 4.1.5(b) would impose a burden on the CPSC and
laboratories, without corresponding benefit. Finally, we note that
fulfillment of the requirements of ISO/IEC 17025:2005 Sec. 4.1.5(b)
may be achieved in a number of ways. Decreasing variability in how
laboratories fulfill that requirement would not necessarily increase
protection against undue influence.
With regard to the suggestion that the submission of records used
to validate fulfillment of ISO/IEC 17025:2005 Sec. 4.1.5(b) would
promote consistency among accreditation bodies, the ILAC-MRA evaluation
process of an accreditation body involves a team of peer review members
drawn from multiple accreditation bodies located around the world. This
multi-member team arrangement tends to harmonize how the requirements
of Sec. 4.1.5(b) of ISO/IEC 17025:2005 are fulfilled around a common
set of principles shared by the globally distributed team members.
With regard to the suggestion that requiring the submission of
evidence of the fulfillment of ISO/IEC 17025:2005 Sec. 4.1.5(b) to the
CPSC would provide us with a means of monitoring compliance, we do not
agree. Records related to accreditation assessments and reassessments
are maintained by the accreditation bodies and the laboratories. The
final rule on the audit requirements (implementing Sec. 14(i)(1) of
the CPSA) requires a third party conformity assessment body to retain
records relating to the last three reassessments conducted by the
accreditation body and make such records available to the CPSC upon
request. Records of nonconformities related to safeguards against undue
influence (or any ISO/IEC 17025:2005 requirement) and the corrective
actions must be made available to the CPSC upon request. Accordingly,
we already have a means of monitoring compliance with this and every
other provision in ISO/IEC 17025:2005.
With regard to the commenter's particular concern with firewalled
and governmental laboratories, CPSC acceptance of these types of
laboratories requires the submission and evaluation of additional
information specifically dealing with avoiding undue influence.
Proposed Sec. 1112.13(b) and (c) provide details of the additional
documentation we would require for CPSC acceptance of the accreditation
of firewalled and governmental laboratories.
The proposed rule would require these additional application
materials from firewalled and government laboratories because we expect
that they will provide us with helpful information concerning the
structure and independence of these applicants.
(Comment 13)--Another commenter similarly pointed out that
independent laboratories can ``easily'' satisfy ISO/IEC 17025:2005
Sec. 4.1.5(b) but stated that the application of this requirement to
firewalled and governmental laboratories ``poses issues of commercial,
financial, and political pressures.'' The commenter suggested that the
CPSC impose ``additional audit requirements and accreditation
decisions'' on firewalled and government laboratories, and that the
CPSC require from such applicants ``additional application information
* * * which should include, but not be

[[Page 31095]]

limited to, extensive public disclosure of both manufacturer and/or
government laboratory personnel involved in the testing of the relevant
product(s).''
(Response 13)--The commenter did not specify what additional audit
requirements or accreditation decisions it thought the CPSC should
impose. However, with regard to this commenter's recommendation that
the CPSC require additional application materials from firewalled and
governmental applicants, as explained in the response to Comment 10,
the proposed rule would require such materials.
We decline the suggestion to require extensive public disclosure of
manufacturer and/or government laboratory personnel. We consider that
mandating such disclosure would constitute an invasion of personal
privacy that would be unwarranted when balanced against the public
interest in the information. See Horowitz v. Peace Corps, 428 F.3d 271
(DC Cir. 2005) (``we must balance the private interest involved
[namely, `the individual's right of privacy'] against the public
interest'').
(Comment 14)--Some commenters suggested that the sampling frequency
of firewalled laboratories should be double that of independent
conformity assessment bodies. Although it was not clear from the
submissions, these commenters may have been suggesting that the
government laboratories also test twice as many samples as independent
laboratories.
(Response 14)--Section 14(a)(2) of the CPSA requires that a
manufacturer of a children's product subject to a children's product
safety rule submit ``sufficient samples of the children's product, or
samples that are identical in all material respects to the product,''
to a third party conformity assessment body for testing. Under the
requirement of the statute, then, it is the manufacturer, as opposed to
the laboratory, who determines what sample is provided to the
laboratory for testing, and the agency has no authority to transfer
responsibility for determining sample size to the laboratories. The
CPSC has addressed the sufficiency of the number of samples required
under section 14(a)(2) of the CPSA in the final rule, Testing and
Labeling Pertaining to Product Certification. 76 FR 69482 (November 8,
2011).
(Comment 15)--Some commenters also suggested that firewalled
laboratories be required to meet additional requirements, such as:

Public disclosure that the manufacturer has a financial
interest or ownership stake in the laboratory;
Submission of materials that identify whether employee
compensation or annual bonuses (including stock options) are tied to
the financial performance of the controlling manufacturer;
Submission of detailed protocols by which the
engineering staff of the firewalled laboratory do not either
transfer from or transfer to the manufacturer's staff, or otherwise
look to the manufacturer for career advancement; and
Evidence that employees are required to participate,
and regularly pass, third party ethics and compliance audits and
programs intended to detect and protect against undue influence. The
International Federation of Inspection Agencies (IFIA) Compliance
Code was mentioned as a possible standard. Employees should also be
required to submit to any programs established by the manufacturer/
firewalled laboratory, including training, reporting, monitoring,
investigating, and enforcement, intended to protect against and
detect undue influence.

(Response 15)--With regard to the suggestion that the CPSC require
firewalled laboratories to publicly disclose that the manufacturer has
a financial interest or ownership stake in the laboratory, section
14(f)(2)(D) of the CPSA provides that a firewalled laboratory may be
accepted by the Commission only if the Commission, by order, makes
certain findings concerning the firewalled laboratory. The orders of
the Commission accepting the accreditation of firewalled laboratories
are public and are posted on the CPSC's Web site. Accordingly, there is
public disclosure of each firewalled laboratory applicant at the time
the Commission votes on whether to accept the firewalled laboratory's
accreditation. (See, e.g., http://www.cpsc.gov/library/foia/foia10/brief/firewalled.pdf).
With regard to the suggestions that firewalled laboratories be
required to identify whether employee compensation or annual bonuses
(including stock options) are tied to the financial performance of the
controlling manufacturer, and that the CPSC require submission of
detailed protocols by which the engineering staff of the firewalled
laboratory do not either transfer from or transfer to the
manufacturer's staff or otherwise look to the manufacturer for career
advancement, we do not believe that such information would be
dispositive. The core concern is whether the testing process will be
tainted, and this concern drives the provisions that were in the
notices of requirements, as well as the provisions in this proposed
rule, which seek to ensure that the testing process is protected
against undue influence. As explained in the response to Comment 16, we
are proposing to expand the definition of ``firewalled laboratory,''
and we are requiring more information from those entities about
safeguards against undue influence.
As we have noted in the responses to Comments 10 and 11, Sec.
4.1.5(b) of ISO/IEC 17025:2005 requires that the laboratory have
arrangements to ensure that it is free from undue influence. The
accreditation body evaluates the laboratory's fulfillment of this
provision at the initial accreditation and at each reassessment.
Further, section 14(f)(2)(D)(ii) of the CPSA requires the Commission,
by order, to find that the conformity assessment body has established
procedures to ensure that its test results are protected from undue
influence by the manufacturer, private labeler, or other interested
party. Because multiple entities are evaluating the means by which the
firewalled laboratory avoids undue influence by the manufacturer,
additional application requirements for firewalled applicants are not
seen as necessary at this time. At a future date, we may consider
additional requirements for firewalled laboratories in response to
evidence that the prevailing requirements are not effective.
Finally, as for the suggestion that we require evidence that
employees are required to participate, and regularly pass, third party
ethics and compliance audits and to submit to any programs established
by the manufacturer/firewalled laboratory intended to detect and
protect against undue influence, we decline to adopt this suggestion.
Under the proposed rule, a firewalled laboratory applicant would be
required to submit, among other things, copies of training documents,
including a description of the training program content), showing how
employees are trained to notify the CPSC immediately and confidentially
of any attempt by the manufacturer, private labeler, or other
interested party to hide or exert undue influence over the third party
conformity assessment body's test results; and training records
(including training dates, location, and the name and title of the
individual providing the training), listing the staff members who
received the required training. At this time, we believe that requiring
these training records sufficiently addresses our interest in ensuring
that firewalled laboratory personnel are adequately trained in
detecting and protecting against undue influence. Again, however, we
will continue to consider this suggestion, and if additional
requirements concerning undue influence-related training of laboratory

[[Page 31096]]

personnel would be helpful, we may recommend adopting additional
training requirements in the future.
(Comment 16)--Other commenters expressed concern about the
situation in which a laboratory and a manufacturer are owned by the
same parent company. The commenter urged the Commission to expand the
definition of ``firewalled laboratories'' to cover common parentage of
laboratories.
The commenter suggested further that the definition of ``firewalled
laboratories'' be extended to include laboratories that do 50 percent
or more of their business with a single manufacturer or private labeler
of children's products.
(Response 16)--We agree that if a laboratory and a manufacturer
share a common corporate parent, and the laboratory intends to test the
manufacturer's children's products for certification purposes, the
laboratory should be considered a firewalled laboratory. The proposed
rule would address the situation of common parentage in the definition
of a ``firewalled laboratory.'' The proposed rule would have an
applicant attest to whether it satisfies any aspect of the definition
of a ``firewalled laboratory.'' One attestation concerns common
parentage; the applicant would need to attest to whether it is
affiliated with a manufacturer or private labeler of the children's
product. ``Affiliated with'' would mean that the conformity assessment
body is in the same ownership network as a manufacturer or private
labeler of the children's product, with the exception that ``affiliated
with'' does not include a manufacturer or private labeler of the
children's product that is owned, managed or controlled by the
conformity assessment body.
We considered the potential controlling effect of manufacturers
with a significant part of a laboratory's business, and concluded that
evaluating such a factor would be challenging administratively and
difficult to verify. Variables such as the time period and types of
products to consider could have a significant impact on any calculation
of a percentage of a laboratory's business.
However, the proposed rule would address management and/or control
of a laboratory by a manufacturer or private labeler by including in
the definition of ``firewalled laboratory,'' laboratories over which a
manufacturer or private labeler has the ability to appoint a majority
of the laboratory's senior internal governing body; the ability to
appoint the presiding official of the laboratory's senior internal
governing body; or the ability to hire, dismiss, or set the
compensation level of laboratory personnel. Another proposed aspect of
this definition would be to deem ``firewalled,'' a laboratory that is
under contract to a manufacturer or private labeler, such that the
contract limits explicitly the services that the laboratory may perform
for other customers or limits explicitly which or how many other
entities may be customers of the laboratory.
(Comment 17)--A commenter suggested that, as a requirement for
accreditation, we consider accrediting only manufacturer-controlled
laboratories that agree that their entire organization, including the
firewalled laboratories, will be held strictly liable for defective
products. For foreign governmental laboratories, the commenter
suggested that we require, as a condition of accreditation, that any
foreign governmental lab that seeks to test and certify products be
required to agree to submit to the jurisdiction of U.S. regulatory
agencies and U.S. courts without asserting claims of sovereign immunity
or other defenses seeking to limit their liability.
(Response 17)--We decline to adopt the commenter's suggestions. The
statutes enforced by the Commission are structured to assign liability
to culpable persons or entities. To the extent that by ``entire
organization,'' the commenter means that the manufacturer owns,
manages, or controls the firewalled laboratory, potential liability
already exists under the statutes enforced by the Commission. It would
be redundant to require the laboratory to agree to such liability as a
condition of becoming accepted by the CPSC. To the extent that the
commenter intends to suggest that the firewalled laboratory itself be
held liable, we do not have the authority to assign liability to an
entity that is not already culpable under the law.
With regard to the suggestion that we require foreign governmental
laboratories to agree to submit to the jurisdiction of U.S. regulatory
agencies and courts without asserting claims of sovereign immunity, or
asserting other bases for limiting their liability, such actions are
beyond the scope of our laboratory accreditation authority.
(Comment 18)--One commenter advised the Commission to ``consider
the liability implications that may arise from accrediting a firewalled
or foreign governmental laboratory in the event that one of those
laboratories permits an unsafe product [to] enter the U.S. marketplace,
as well as the legal remedies thereto.''
(Response 18)--We interpret the commenter as expressing concern
that there may be obstacles to the CPSC holding CPSC-accepted
firewalled and foreign governmental laboratories legally accountable
for the tests they conduct. Section 14(f) of the CPSA establishes that
firewalled and governmental laboratories may be accredited by the
Commission to conduct third party tests of children's products. We wish
to assure this commenter that we pursue available legal remedies
against entities that permit unsafe products to enter the U.S.
marketplace. We also note that, under the proposed rule, the Commission
would be able to withdraw its acceptance of a laboratory on such
grounds as the laboratory failed to comply with the requirements of
subpart B of the proposed rule, and/or if the laboratory succumbs to
undue influence.
(Comment 19)--One commenter suggested that we require assessments
of a laboratory's independence and freedom from undue influence
annually, or at least require that these assessments coincide with
other reassessment and surveillance visits.
(Response 19)--We agree that a laboratory's independence should be
reassessed on a regular basis. The final rule on audit requires that
the reassessment portion of an audit, which is conducted by the
accreditation body, include an examination of the laboratory's
management system to ensure that the laboratory is free from any undue
influence.
In addition to a laboratory's reassessment visits, surveillance
visits can be conducted by accreditation bodies during the period
between reassessments. Surveillance visits are assessments that are
conducted for a particular purpose, such as to follow up on a
previously observed problem or to ensure that a newly accredited
laboratory has implemented necessary procedures. Surveillance visits
may or may not be conducted for purposes of reviewing the impartiality
of a laboratory, and thus, may or may not involve a reassessment of a
laboratory's impartiality.
(Comment 20)--A commenter suggested that there is no objective
basis for assessing the additional application materials submitted by
governmental conformity assessment bodies.
(Response 20)--We interpret the commenter's suggestion as urging
the Commission to issue objective standards for assessing these
applications. Section 14(f)(2) of the CPSA, as amended by section 102
of the CPSIA, establishes five criteria which, in addition to the
baseline requirements, a third party conformity assessment body owned
or controlled, in whole, or in part, by a

[[Page 31097]]

government must satisfy. These criteria are:

(i) to the extent practicable, manufacturers or private labelers
located in any nation are permitted to choose conformity assessment
bodies that are not owned or controlled by the government of that
nation;
(ii) the entity's testing results are not subject to undue
influence by any other person, including another governmental
entity;
(iii) the entity is not accorded more favorable treatment than
other third party conformity assessment bodies in the same nation
who have been accredited under this section;
(iv) the entity's testing results are accorded no greater weight
by other governmental authorities than those of other third party
conformity assessment bodies accredited under this section; and
(v) the entity does not exercise undue influence over other
governmental authorities on matters affecting its operations or on
decisions by other governmental authorities controlling distribution
of products based on outcomes of the entity's conformity
assessments.

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

In order for us to evaluate whether a governmental laboratory
applicant satisfies the statutory criteria, we have developed a
standard questionnaire and requests for documentation that each
governmental laboratory applicant is asked to complete. The
questionnaire accompanies the proposed rule as part of the CPSC's
Paperwork Reduction Act package, and the required documents are
described in proposed Sec. 1112.13(c)(2). In addition, CPSC staff
reviews governmental laboratory applications using a standardized
review document that provides grounds and reasoning for a finding
relative to each of the five statutory criteria. These standardizations
provide increased objectivity to the application review process, and
the questionnaire and documentation requirements are being published
via this proposed rule.
(Comment 21)--Some commenters that are foreign governments
contended that, rather than assess additional application materials
before acting on a governmental laboratory application, we should
accept each governmental laboratory applicant, unless there is evidence
that the applicant fails to satisfy the statutory criteria. The
commenters argued that our approach is not fair and is inconsistent
with the principal of impartiality expressed in the statutory
criterion, which requires that the applicant laboratory ``is not
accorded more favorable treatment than other third party conformity
assessment bodies in the same nation who have been accredited.''
The commenters also argued that our approach violates the ``mutual
recognition principle of conformity assessment procedures'' under the
international treaty, ``Agreement on Technical Barriers to Trade'' (TBT
Agreement). The commenters also invoked article 6.3 of the TBT
Agreement, which encourages members to negotiate agreements for the
mutual recognition of conformity assessments, and the commenters
suggested additional consultations on these issues.
One commenter raised several issues under the World Trade
Organization's TBT Agreement. The commenter stated that Article 2.4 of
the TBT Agreement requires members to use relevant international
standards (if they exist) as a basis for their technical regulations
and said that ISO 9239-1, Reaction to fire tests for floorings--Part 1:
Determination of the burning behavior using a radiant heat source, ISO
9239-2, Reaction to fire tests for floorings--Part 2: Determination of
flame spread at a heat flux level of 25 kW/m2, and ISO 6925, Textile
floor coverings--Burning behavior--Tablet test at ambient temperature,
``contain specifications to fire tests for floorings.'' The commenter
said that these international standards ``would be an effective and
appropriate means for the fulfillment of the objective pursued by
CPSC.''
Finally, another commenter referred to Article 5.1.2 of the TBT
Agreement to state that ``conformity assessment procedures shall not be
more strict than necessary to give the Importing Member adequate
confidence that products conform to the applicable technical
regulations or standards.'' The commenter also cited Articles 2.4, 2.5,
2.9.3, 5.4, and 5.6.3 of the TBT Agreement and asked us to ``identify
parts, if any, of the new regulation which in substance deviate from
relevant international standards and to explain why such deviation has
become necessary.''
(Response 21)--To the extent that these commenters are suggesting
that our approach has been partial to nongovernmental laboratory
applicants, we acknowledge that there are criteria imposed by the CPSIA
that apply only to governmental laboratory applicants. We have chosen
to determine whether the criteria are satisfied before acting on each
application. Similarly, we have not accepted any firewalled laboratory
applicant without determining first that it satisfies the statutory
criteria relevant to that type of laboratory (see section (f)(2)(D) of
the CPSA). We have chosen to defer action on governmental and
firewalled laboratory applications until we determine that the
statutory criteria are satisfied because we want to ensure that CPSC-
accepted third party conformity assessment bodies have the structures
and practices required by the statute to avoid undue influence, or any
other interference with, or compromise to, the integrity of the testing
process. This is consistent with the goal of the CPSIA that children's
products that enter the U.S. marketplace have been tested by a
competent and unbiased laboratory.
We do not agree that this approach is unfair. Because neither
governmental nor firewalled laboratories are independent entities, both
are potentially subject to undue influence from the organizations to
which they are connected, which have interests beyond product testing.
The CPSIA imposes additional requirements on firewalled and government
laboratories so that only laboratories that are arranged to avoid undue
influence sufficient to satisfy the statutory criteria may be accepted.
We remain committed to implementing the conformity assessment program
established by the CPSIA fairly and with the primary goal of product
safety in mind.
The notices of requirements have not contradicted the TBT
Agreement. We are willing to accept laboratories recognized by foreign
governments if the laboratories satisfy the statutory requirements,
including the five statutory criteria listed above (as long as the
laboratory satisfies the baseline criteria) in the case of laboratories
owned or controlled in whole, or in part, by a government. In fact, we
have accepted the accreditations of several governmental laboratories,
and we have applied the same statutory criteria to governmental
laboratories, regardless of whether the governmental laboratory was
located in a foreign country or in the United States. (Indeed, we note
that the definition of ``government participation'' in section
14(f)(2)(B) of the CPSA (for purposes of a ``third party conformity
assessment body'') is not limited to foreign governments.) The CPSC
consults extensively with laboratories seeking to become accepted to
test products under section 14 of the CPSA. We remain open to further
consultation on these issues with any interested laboratory applicant.
With respect to specific articles in the TBT Agreement, the
commenter addressing Article 2.4 of the TBT agreement may have
misinterpreted the notice of requirements. The notice of requirements
simply establishes the conditions under which the CPSC will accept the
accreditation of a third party conformity assessment body to test a
children's product for compliance with a particular children's product
safety rule. The notice of requirements does

[[Page 31098]]

not affect the regulations pertaining to the children's product itself.
Similarly, the commenter addressing Article 5.1.2 of the TBT
agreement may have misinterpreted the notice of requirements. This
commenter was responding to the notice of requirements pertaining to 16
CFR part 1630, Standard for the Surface Flammability of Carpets and
Rugs (FF 1-70) and/or part 1631, Standard for the Surface Flammability
of Small Carpets and Rugs (FF 2-70) (See 75 FR 42315 (July 21, 1010)).
The notice of requirements for 16 CFR parts 1630 and/or 1631, however,
did not affect or alter the standards established or test methods
required in 16 CFR parts 1630 and/or 1631. It simply informed
laboratories of the process and requirements by which they could apply
to test children's products according to the test method detailed in
parts 1630 and/or 1631. A laboratory that has been ISO/IEC 17025:2005-
accredited by an ILAC-MRA signatory to conduct flammability tests for
floor coverings pursuant to a standard other than 16 CFR parts 1630
and/or 1631 that has similar test methods would likely not find it
difficult to expand its accreditation scope with its accreditation body
to include 16 CFR parts 1630 and/or 1631 and subsequently apply to the
CPSC to test children's products subject to these regulations.
Moreover, consistent with Article 5.1.2 of the TBT Agreement, the
notices of requirements have not established procedures and
requirements for laboratories that are more strict than necessary to
give the CPSC adequate confidence that children's products tested by
CPSC-accepted laboratories conform to applicable CPSC standards,
regulations, rules, or bans. We are unclear which relevant
international standards the commenter would like us to compare the
notices of requirements and explain why differences between the two are
necessary. To the extent that the commenter is asking for differences
between various substantive safety standards, we again note that the
notices of requirements do not affect the underlying consumer product
safety standard or children's product safety rule.

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

(Comment 22)--Some commenters suggested that if a third party
conformity assessment body tested a product later found to be
noncompliant with the applicable rules, that conformity assessment body
should lose its accreditation temporarily. (We interpret ``lose
accreditation'' to mean a loss of the CPSC's acceptance of their
accreditation.) The commenters suggested varying loss schedules,
depending on the type of laboratory, with increasing periods of
suspension for repeat offenses. For firewalled and government
laboratories, the commenters suggested that acceptance of their
accreditation should be lost for three months after the first offense,
six months after the second offense, one year after the third offense,
and permanent loss for four offenses over a 2-year period. For
independent laboratories, the commenters suggested a written warning
after the first offense, a 1-month loss after the second offense, a 3-
month loss after the third offense, and upon the fourth offense, the
CPSC would reevaluate the laboratory's practices, and the accreditation
body would conduct a reassessment.
(Response 22)--We decline to adopt the suggestion that laboratories
lose CPSC acceptance of their accreditation (either for a specified
time or permanently) after noncompliant products associated with the
laboratories' test reports are found in the marketplace. Factors
independent of the laboratory may have led to the presence of
noncompliant products. For example, poor process control by the
manufacturer after certification could lead to some noncompliant
products being produced after the laboratory had tested compliant
samples. As another example, a manufacturer may have made a material
change to the product that affected the product's compliance, without
sending samples for testing to a laboratory. Setting a withdrawal
schedule based solely on the presence of noncompliant products would
risk holding laboratories responsible for factors beyond their control
and about which they had no knowledge.
In addition, we are not adopting a graduated system of penalties
because we consider it preferable to deal with laboratory infractions
on a case-by-case basis.
(Comment 23)--Some commenters suggested that we establish a defined
system for ``de-listing'' a third party conformity assessment body
``for just cause.'' (We interpret ``de-listing'' to mean that the CPSC
withdraws its acceptance of the laboratory's accreditation and removes
the laboratory from the listing of accepted laboratories on the CPSC
Web site http://www.cpsc.gov/cgi-bin/labsearch). The commenter provided
examples of what would constitute ``just cause'':

Evidence of conflict of interest or where there is
undue influence by a manufacturer, a common parent company, or other
party, that could have affected test results;
A laboratory has been found to be incompetent to
conduct required testing due to personnel or laboratory equipment
changes; or
A laboratory has a record of repeatedly certifying
products that are later identified as noncompliant.

(Response 23)--We agree with the commenter that there should be
greater clarity of what conduct or circumstances are sufficient for the
agency to withdraw its acceptance of the accreditation of a third party
conformity assessment body. Subpart D of the proposed rule would
address adverse actions that the CPSC may take against a laboratory.
These adverse actions would include: withdrawing CPSC acceptance of a
laboratory's accreditation and removing the laboratory from the CPSC
Web site listing of accepted laboratories. Proposed Sec. 1112.47 would
establish three basic grounds for withdrawal, which would include a
manufacturer, private labeler, or governmental entity exerting undue
influence on the laboratory or otherwise interfering with or
compromising the integrity of the testing process. Proposed Sec.
1112.41 would establish the procedures for withdrawal.

D. Comments on Specific Notices of Requirements

1. Lead Content in Children's Metal Jewelry
(Comment 24)--Another commenter requested an exclusion in the CPSC
test method for determining total lead in children's metal products
(including children's metal jewelry). The commenter suggested that
samples of electroplated jewelry--for which the electroplating is a
metal excluded from testing for lead (such as gold or silver)--not be
required to contain the electroplating when tested. The commenter
suggested the following change to procedures A.2 and B.2:

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

(Response 24)--We decline to make the suggested change to the CPSC
test method, CPSC-CH-E1001-08, because test methods are an
inappropriate place to list testing exclusions. The test method is
limited to describing how to conduct a test, not whether a material
should be tested.

[[Page 31099]]

The commenter is correct that an excluded material, such as gold of
at least 10 karats, does not require testing for lead. On August 26,
2009, the Commission published in the Federal Register, a list of
materials determined not to contain lead and excluded them from testing
(74 FR, 43031). This created a new section, Sec. 1500.91 of the
Hazardous Substances and Articles: Administration and Enforcement
Regulations.
If the commenter submits samples for testing without the
electroplating, those test results, combined with the exclusion for a
plating material (such as gold greater than 10 karats) could be used as
the basis for issuing a Children's Product Certificate for a finished
product consisting of units from the same lot or batch as the samples,
plus the electroplating. However, once the electroplating occurs, the
combination of the base material and the electroplating are considered
one component part. If finished product samples are submitted for
testing, the electroplating must be part of the tested specimen.
(Comment 25)--A commenter urged the CPSC to consider X-ray
fluorescence (XRF) spectrometry as a valid testing option to screen for
products with very low lead levels; more precise testing would be
required if the uncertainty range of the instrument included the lead
concentration limit.
Another commenter urged the CPSC to consider the use of a specific
XRF technology, energy dispersive- X-ray fluorescence spectrometry
(EDXRF), as a validated method for the testing of lead in substrates of
consumer products. The commenter referred to interlaboratory testing
that compared EDXRF technology to ``wet chemistry'' techniques
(Inductively Coupled Plasma and Atomic Absorption Spectrometry) to
measure lead in multiple substrates. The commenter opined that the
economic and other benefits of using EDXRF over ``wet chemistry'' may
be even more pronounced with application to the nondestructive
measurement of lead in the substrate of product samples.
(Response 25)--The CPSC has accepted the use of certain types of
XRF testing but only for certain polymeric materials and for paints.
The CPSC test method, CPSC-CH-E1002-08 (and its revision, CPSC-CH-
E1002-8.1), Standard Operating Procedure for Determining Total Lead
(Pb) in Non-Metal Children's Products, includes an option for the use
of XRF for the analysis of lead in certain polymeric materials. See 74
FR 55820 (Oct. 29, 2009) (notice of requirements for total lead in
children's products); see also 76 FR 6765 (Feb. 8, 2011) (notice
extending the stay of enforcement pertaining to total lead content in
children's products [except for metal components of children's metal
jewelry] until December 31, 2011). ASTM International, formerly the
American Society for Testing and Materials (ASTM) test method, F2853-
10, Standard Test Method for Determination of Lead in Paint Layers and
Similar Coatings or in Substrates and Homogeneous Materials by Energy
Dispersive X-Ray Fluorescence Spectrometry Using Multiple Monochromatic
Excitation Beams, can be used for the analysis of lead content in
paints (16 CFR part 1303). See 76 FR 18645 (Apr. 5, 2011) (revision to
notice of requirements for lead paint).
This proposed rule also would allow the use of XRF to determine the
lead content of glass materials, crystals, and certain metals. We will
continue to evaluate improvements to technology and methods on an
ongoing basis.
2. Total Lead in Children's (Metal and Non-Metal) Products
(Comment 26)--A commenter suggested that we expand the use of XRF
beyond polymeric materials, to test paints and thin film coatings for
the purposes of a manufacturer, importer, or retailer's providing
certification. Another commenter said we should allow the XRF method
described in ASTM F2853-10 to be used to measure lead content in
multiple substrates, in addition to homogeneous polymeric materials.
(Response 26)--On April 5, 2011, we published a notice revising the
requirements for accreditation of laboratories to test for lead in
Paint. In that notice, the Commission approved the use of ASTM
International (formerly the American Society for Testing Materials,
ASTM) test method, F2853-10, Standard Test Method for Determination of
Lead in Paint Layers and Similar Coatings or in Substrates and
Homogeneous Materials by Energy Dispersive X-Ray Fluorescence
Spectrometry Using Multiple Monochromatic Excitation Beams, for the
analysis of lead content in paint. We have not determined that other
XRF technologies are as effective, precise, or reliable as the methods
described in the notice of requirements for compliance determinations
of paints.
Additionally, the proposed rule (at proposed Sec. 1112.15(b)(28),
(29), and (30)) would allow the use of XRF to determine the lead
content of glass materials, crystals, and certain metals. We will
continue to evaluate improvements to technology and methods on an
ongoing basis.
(Comment 27)--Another commenter suggested that, in addition to
using a cryogenic mill for sample preparation, we should allow the test
specimen to be cut into small representative pieces, with a maximum
length in any dimension of 2.0 millimeters. The commenter also
suggested a procedural change in the test method for determining lead
in metals (CPSC-CH-E1001-08). The suggested change calls for the tester
to observe when no particles are visible in one step and omits a
heating period in another step.
(Response 27)--New revisions, dated June 21, 2010, of CPSC test
methods: CPSC-CH-E1001-08.1 and CPSC-CH-E1002-08.1 have been posted on
the CPSC's Web site. In test method CPSC-CH-E1002-08.1, the commenter's
suggestion has been implemented. The sample preparation method
instructs the tester to:

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

With regard to the suggested change in test method CPSC-CH-E1001-08, we
do not have sufficient proof that the method of not heating the acid to
60 degrees C (in step 6 of the Hot Block method), or using a longer
time period, would result in consistent measurements. In addition to
the Hot Block Method, we allow another testing method, based on the
EPA's method 3051A2, which uses microwave digestion. Both methods are
allowed in the revised test method, CPSC-CH-E1001-08.1.
3. 16 CFR Part 1303--Lead in Paint
(Comment 28)--Two commenters noted that the absence of a specified
testing method in 16 CFR part 1303, Ban of Lead-Containing Paint and
Certain Consumer Products Bearing Lead-Containing Paint, leads to
uncertainty and confusion among accreditation bodies and laboratories
about which testing methods are adequate for meeting the requirements
of the standard.
(Response 28)--We addressed these comments in a notice published in
the Federal Register on April 5, 2011, in which we amended the notice
of requirements for testing for lead paint (see 76 FR 18645). The
notice of requirements listed the test methods that are approved for
compliance determination: CPSC-CH-E1003-09, CPSC-CH-E1003-09.1 and/or
ASTM

[[Page 31100]]

F2853-10 (which uses a specific type of XRF technology).
(Comment 29)--A commenter encouraged us to continue to ensure that
the current ASTM F40 Committee (Declarable Substances in Materials)
review process of a proposed standard method for lead in paint using
traditional XRF technologies undergoes the same rigorous scientific and
statistical requirements as we used during the ASTM F2853-10 standard
method development process.
(Response 29)--We will continue to evaluate improvements to
technology and methods on an ongoing basis. We have not determined that
other XRF technologies are as effective, precise, or reliable as the
methods described in the notice of requirements for determination of
the lead content in paint.
4. 16 CFR Parts 1630 and 1631--Carpets and Rugs
(Comment 30)--A commenter requested that we continue the stay with
respect to handmade ``Oriental'' carpets. The regulation at 16 CFR
1630.2(b) states: ``[o]ne of a kind, carpet or rug, such as an antique,
an Oriental, or a hide, may be excluded from testing under this
Standard pursuant to conditions established by the Consumer Product
Safety Commission.'' There is a corresponding regulation applying to
small carpets and rugs at 16 CFR 1631.2(b). The commenter noted that we
have not established such conditions, and encouraged us to do so.
Pending the establishment of the conditions, the commenter sought a
continuation of the stay.
(Response 30)--We decline to continue (or reinstitute) the stay for
handmade ``Oriental'' carpets. With regard to children's products,
publication of the notice of requirements regarding carpets and rugs on
July 21, 2010 had the effect of lifting the stay. With regard to non-
children's products, we announced the lifting of this stay, effective
January 26, 2011. 75 FR 81236, December 27, 2010. The CPSIA was enacted
in August 2008; the carpets and rugs industry had ample opportunity to
prepare for the law's testing and certification requirements.
In the years since the flammability regulations at 16 CFR parts
1630 and 1631 were promulgated, we have handled, on an individual
basis, requests for exclusion of one-of-a-kind carpets or rugs. The
commenter is correct that we have not formally established the
conditions under which a carpet or rug would be excluded under 16 CFR
1630.2(b) and/or 1631.2(b), but such matters are outside the scope of
this rulemaking.
(Comment 31)--Some commenters recommended that we support and
approve the testing of flammability of carpets and rugs by laboratories
accredited by the National Voluntary Laboratory Accreditation Program
(NVLAP). One commenter added that this should also include ``internal''
laboratories. The commenters expressed the opinion that that the
existing procedures (testing methods, protocols, and recordkeeping
requirements) in FF 1-70 (16 CFR part 1630) and FF 2-70 (16 CFR part
1631) are effective in protecting consumers and children and that no
additional safety benefit is gained by ``different testing protocols.''
One commenter expressed the belief that the requirement for
accreditation of third party conformity assessment bodies to assess
conformity with 16 CFR parts 1630 and/or 1631 will only add costs, with
no additional safety benefits, for children's carpet and rug products.
(Response 31)--It is common for U.S. laboratories that test carpets
and rugs in accordance with 16 CFR part 1630 and/or 1631 to be ISO/IEC
17025:2005-accredited by NVLAP. Because NVLAP is a signatory to the
ILAC-MRA, it may be a Commission-designated accreditation body, as
prescribed in the notices of requirements. Several NVLAP-accredited
laboratories have been accepted and posted on our Web site for testing
to 16 CFR parts 1630 and 1631. Worldwide, there are more than 25 CPSC-
accepted laboratories for 16 CFR part 1630 and/or 16 CFR part 1631
(with several different ILAC-MRA accreditation bodies represented).
Thus, NVLAP accreditation is not inconsistent with CPSC acceptance of
third party conformity assessment bodies (laboratories) for testing to
16 CFR parts 1630 and/or 1631.
In response to the commenter who asked that we allow internal
laboratories that are accredited by NVLAP, we interpret the comment as
referring to laboratories that are owned by carpet or rug
manufacturers. In these cases, the notice of requirements allows NVLAP
accreditation to serve as a ``baseline'' requirement for CPSC
acceptance. However, in accordance with the CPSA (as amended by the
CPSIA), laboratories that are owned by a manufacturer of a product that
is subject to the regulation for which it conducts tests must meet
additional criteria for Commission acceptance as a firewalled third
party conformity assessment body.
As for the commenters suggesting that the implementation of
different testing protocols will provide no safety benefit, the notice
of requirements makes no changes to the flammability test methods that
appear in 16 CFR parts 1630 and 1631. The commenters may be referring
to the language in section 14(a)(2) of the CPSA (as amended by the
CPSIA) that the manufacturer ``must submit sufficient samples of the
children's product, or samples that are identical in all material
respects to the product,'' for testing by a CPSC-accepted third party
conformity assessment body, and/or the CPSA language in section
14(i)(2)(B) related to Commission rulemaking for a continued testing
program (including periodic and random sample testing, and compliance
labeling). These ``testing protocols'' are required for children's
carpets and rugs by the CPSIA and the recently issued final rule
Testing and Labeling Pertaining to Product Certification, (76 FR 69482
(November 8, 2011) (to be codified at 16 CFR part 1107)).
(Comment 32)--One commenter asked whether conformity assessment
bodies in its country that were accredited by a signatory to the ILAC-
MRA and accredited to ISO 9239-1, 9239-2, and 6925 ``fulfill the
requirements listed in 16 CFR parts 1630 and 1631'' or whether there
are additional requirements that a conformity assessment body must meet
to have CPSC accept its accreditation.
(Response 32)--The purpose of the CPSC's laboratory program is to
authorize laboratories to conduct CPSC tests capable of supporting a
Children's Product Certificate. Although there may be other product
standards and test methods in existence, the purpose of this program is
limited to conducting third party tests of children's products under
section 14 of the CPSA. A laboratory must be accredited by an ILAC-MRA
signatory to ISO/IEC 17025:2005 and must have the relevant CPSC
regulation or test method in its scope of accreditation to apply
successfully for CPSC acceptance of its accreditation. ISO 9239-1,
9239-2, and 6925 all specify methods for assessing the burning behavior
of floorings and/or floor coverings. The CPSC regulations at 16 CFR
parts 1630 and 1631 assess the surface flammability of carpets and
rugs. To the extent that a laboratory was accredited to ISO/IEC
17025:2005, but it did not have 16 CFR part 1630 and/or 1631 in its
scope of accreditation, it would not be eligible for acceptance by the
CPSC to test children's products under 16 CFR part 1630 and/or 1631.
The CPSC standards contain specific test methods for assessing
compliance with CPSC requirements. Because other test methods do not
assess for compliance with CPSC requirements, accreditation to such
other test methods is not sufficient for CPSC acceptance of
accreditation.

[[Page 31101]]

(Comment 33)--One commenter, a government agency, said that the
notice of requirements raised serious concerns for the textile industry
in its country and ``may imply new additional costly requirements.''
(Response 33)--We believe that the commenter may have
misinterpreted the notice of requirements. The regulations pertaining
to carpets and rugs have been in place for several decades, and the
notice of requirements did not alter those regulations. To the extent
that the commenter is expressing concern over the cost of third party
testing for children's products, such a comment is beyond the scope of
the proposed rulemaking because this proposed rule would establish
requirements for laboratories, and it would not address testing costs
associated with manufacturers.
5. Requirements for Electrically Operated Toys or Other Electrically
Operated Articles Intended for Use by Children
(Comment 34)--A commenter suggested that we should accept
evaluation results from certification bodies recognized by OSHA as a
NRTL with UL 696 in their scope of recognition. According to the
commenter, the requirements in UL 696 are ``nearly identical'' to those
in 16 CFR part 1505.
(Response 34)--As explained more fully above in the response to
Comment 2, in order to ensure a consistent, global approach toward CPSC
acceptance of accredited laboratories, we have decided to consider
acceptance only of laboratories accredited by ILAC-MRA signatory
accreditation bodies.
In addition, and as explained in the response to Comment 31,
concerning carpets and rugs, a laboratory that wishes to conduct tests
upon which a manufacturer of a children's product subject to a
particular rule may base a certificate of compliance, must have that
particular rule listed in its scope of accreditation. This requirement
ensures that the laboratory understands the CPSC regulation and test
methods associated with the regulation and has been evaluated as
competent to conduct that testing. Although UL 696 has been revised to
be consistent with 16 CFR 1505, an NRTL laboratory with UL 696 in its
scope of recognition must be accredited to ISO/IEC 17025:2005 by an
ILAC-MRA signatory accreditation body to 16 CFR part 1505 before the
laboratory may apply to the CPSC for acceptance of that accreditation.
6. 16 CFR Parts 1632 and 1633--Mattresses, Mattress Pads, and Mattress
Sets
(Comment 35)--One commenter urged us to adopt a longer
implementation period for third party testing under 16 CFR part 1632
and to broaden this notice of requirements' retrospective testing
provisions.
(Response 35)--We already responded to this comment in a notice
published in the Federal Register on November, 29, 2010 (75 FR 72944),
in which we revised the retrospective testing provision applicable to
third party testing under 16 CFR parts 1632 and 1633.
7. 16 CFR Part 1420--Youth All-Terrain Vehicles (ATVs)
(Comment 36)--One commenter supported our publication of the notice
of requirements for ATVs, and they specifically offered support for the
``CPSC's analysis to determine whether an ATV is intended for a child
and not just rely[ing] on what the ATV industry/manufacture[r] states
that it is.'' Some commenters expressed safety concerns with ATVs. Two
commenters (49A, 51C) suggested that the CPSC include Y-12+ model ATVs
in the ``youth ATV'' category, along with the Y-6+ and the Y-10+
models. One commenter claimed that the CPSC is excluding the Y-12+
model from the category ``youth ATV.'' The commenter stated that
because the models are intended to be used by 12 year olds, they should
fall under the scope of the CPSIA's definition of a ``children's
product.'' Both commenters noted that because the T model ATV is
intended for children 14 years old and older, the Y-12+ model will be
used primarily by children 12 and 13 years old.
(Response 36)--Section 232 of the CPSIA required us to establish
the American National Standard for Four-Wheel All-Terrain Vehicles
Equipment Configuration, and Performance Requirements developed by the
Specialty Vehicle Institute of America (American National Standard
ANSI/SVIA-1-2007) as a mandatory standard for four-wheel all-terrain
vehicles.
This standard includes ``Category Y'' classifications, which are
for off-road use by operators under age 16. These categories are: Y-6+,
intended for use by children age 6 or older; Y-10+, intended for use by
children age 10 or older; Y-12+, intended for use by children age 12 or
older; and T, intended for use by children age 14 or older with adult
supervision, and by persons age 16 or older. While we appreciate the
comment that a significant percentage of the riders of the Y-12+ model
will be children 12 years old, and not the children who are older than
12, no data were provided to support that statement.
We do not have data to indicate which portion of the ``12 or
older'' category represents the rider of Y-12+ ATV models most. The
CPSIA defines a ``children's product'' in Sec. 3(a)(2) of the CPSA as:

(2) CHILDREN'S PRODUCT.--The term ``children's product'' means a
consumer product designed or intended primarily for children 12
years of age or younger. In determining whether a consumer product
is primarily intended for a child 12 years of age or younger, the
following factors shall be considered:
(A) A statement by a manufacturer about the intended use of such
product, including a label on such product if such statement is
reasonable.
(B) Whether the product is represented in its packaging,
display, promotion, or advertising as appropriate for use by
children 12 years of age or younger.
(C) Whether the product is commonly recognized by consumers as
being intended for use by a child 12 years of age or younger.
(D) The Age Determination Guidelines issued by the Commission
staff in September 2002, and any successor to such guidelines.

We cannot categorically include Y-12+ model ATVs as ``youth ATVs''
because the age range for that model includes children over the age of
12; however, the definition of a ``children's product'' is limited to
products designed or intended primarily for children 12 years of age or
younger. When it is unclear whether a product should be considered a
children's product, we will apply the four factors. Different
manufacturers may mark, package, and market their ATVs as primarily
intended for children older than 12, or as primarily intended for 12
year olds. We will determine on a per-model basis, using the four
factors listed above, whether a particular model Y-12+ ATV is primarily
intended for use by children 12 years of age or younger (and is
therefore considered a children's product in need of third party
testing to support a certification). Indeed, some commenters commended
the CPSC for applying the four statutory factors, rather than relying
solely on the manufacturer's statements regarding whether an ATV is
intended for a child.
The commenter is incorrect that we have excluded Y-12+ model ATVs
from third party testing. In the notice of requirements that appeared
in the Federal Register on August 27, 2010, we stated: ``for the
purposes of this notice of requirements, the term `youth' ATVs at a
minimum refers to categories Y-6+ and Y-10+ in ANSI/SVIA 1-2007.'' (See

[[Page 31102]]

75 FR at 52616; emphasis added). Thus, we have indicated that the Y-12+
model may be considered for inclusion as a product that must meet third
party testing requirements. Again, it will depend upon application of
the four factors to a particular model.
On August 12, 2011, the President signed into law Public Law 112-
28, which amended the CPSIA in several respects. One provision in PL
112-28 created an exception from the lead limits for off-highway
vehicles. Consequently, ATVs, recreational off-highway vehicles, and
snowmobiles are no longer subject to the lead limits in section 101 of
the CPSIA. We also note that recently, a final rule revising 16 CFR
part 1420, in which American National Standard ANSI/SVIA-1-2010 will
become the new mandatory standard effective April 30, 2012, was
published in the Federal Register. See 77 FR 12197 (February 29, 2012).
This standard, which pertains to ATVs, is an updated version of the
standard that was the subject of the notice of requirements that
appeared in the Federal Register of August 27, 2010 (75 FR 52616).
(Comment 37)--One commenter requested that we extend the date on
which ATV manufacturers must begin third party testing and
certification. The commenter further requested that we consider
additional forms of relief if there continues to be an insufficient
number of CPSC-accepted laboratories.
(Response 37)--We responded to this comment in notices published in
the Federal Register on December 9, 2010 (75 FR 76709) and February 1,
2011 (76 FR 5565), in which we first extended, and then conditionally
stayed, third party testing for youth ATVs.
Additionally, as noted in the response to Comment 36, all-terrain
vehicles, recreational off-highway vehicles, and snowmobiles are no
longer subject to the lead limits in section 101 of the CPSIA.
8. Toys and ASTM F 963
(Comment 38)--Two entities submitted letters before we published
the notice of requirements pertaining to ASTM F-963-08 (76 FR 46598
(August 3, 2011)), and these letters were placed in the administrative
record as comments. For convenience, we will refer to the entities as
commenters. (We did receive a third submission, but it appeared to be
from a laboratory seeking to be listed as a third party conformity
assessment body, rather than a comment on the notices of requirements.)
One commenter urged us to refrain from issuing a notice of
requirements to ASTM F 963 because it said that requiring third party
testing would ``dramatically and permanently harm small batch
toymakers.'' The commenter sought an indefinite stay of enforcement of
the third party testing requirements for ASTM F 963 or delayed
publication of the notice of requirements. The commenter cited testing
costs, the impact of a third party testing requirement relative to the
production of toys for the holiday season, the complexity of ASTM F
963, and congressional consideration of changes to the CPSIA.
Another commenter expressed concern about ``potential confusion in
the marketplace that may result from a lack of coordination between
timing of the effective date'' of a third party testing requirement and
revisions to the ASTM F 963 toy standard. It recommended that we set
the effective date of third party testing requirements to coincide with
an expected revision of the toy standard and the date on which the
revision would become a mandatory standard (as provided by section 106
of the CPSIA). It also urged us to clarify that, in cases where
requirements overlap between versions of the standard, manufacturers do
not need to test to demonstrate compliance with both standards. The
commenter also sought flexibility on the acceptance of retrospective
testing because, it explained, delays in our acceptance of third party
conformity assessment body accreditation could force ``redundant
testing'' on manufacturers who seek to test to new or revised standards
before their effective date.
(Response 38)--With respect to the request to refrain from issuing
the notice of requirements or to issue an indefinite stay of
enforcement, we note that the notice of requirements with regard to
ASTM F-963 published in the Federal Register on August 3, 2011 (76 FR
46598), and therefore, this comment is moot. Thus, the request to
refrain from issuing the notice of requirements is moot. We also
decline to issue an indefinite stay of enforcement. We note, however,
that the notice of requirements, as well as changes resulting from
Public Law 112-28, have addressed some of the commenter's concerns. For
example, in the notice of requirements pertaining to ASTM F-963, the
Commission stated that it would ``stay enforcement of the testing and
certification requirements of section 14 of the CPSA with respect to
toys subject to ASTM F 963 until December 31, 2011'' (76 FR at 46601).
Public Law 112-28 also provided some relief, specifically to small
batch manufacturers, through the creation of a new section 14(i)(4) of
the CPSA, which establishes ``special rules'' for small batch
manufacturers that would result in alternative testing requirements or
exemptions from third party testing.
As for the second commenter's concern about effective dates,
revisions to the toy standard, and potentially ``redundant'' testing,
we are sensitive to potential disruptions and confusion that may result
when standards are revised. The notice of requirements acknowledges
that we anticipated another revision to ASTM F-963 and invited comment
on ``how to make the transition in testing requirements as clear and
efficient as possible should the standard change'' (76 FR at 46599).
The enactment of Public Law 112-28 has magnified the need to develop
policies with respect to transitions in testing requirements when
standards change, because Public Law 112-28 revised section 104 of the
CPSIA to establish a process for subsequent revisions to voluntary
standards for durable infant and toddler products. The resulting
process is similar to that under section 106 of the CPSIA (which
pertains to toys and ASTM F-963). The issuance of future notices of
requirements, relative to revised or changing standards, is complicated
further by the fact that, after August 14, 2011, all notices of
requirements are subject to the rulemaking requirements in 5 U.S.C. 553
and 601 through 612 of the Administrative Procedures Act.
Nevertheless, we agree that ``redundant'' testing should not be
necessary when the relevant provision in the toy standard has not
changed, or not changed in a manner that would affect how testing is
conducted between revisions. For example, assume that a provision in
the 2008 version of the standard imposed a particular test on a toy. If
the standards organization revised the standard in 2011, such that a
provision in the revised 2011 standard imposes the same test as the
2008 standard or a ``functionally equivalent'' test to the 2008
standard on the toy, then we believe it would be unnecessary to require
manufacturers to take toys that had been tested to the 2008 standard
and retest them to the 2011 standard. (By ``functionally equivalent,''
we mean that the standards organization has made certain changes in the
revised standard, as compared to the earlier standard, but the changes
are not substantial, and they do not affect the associated conformance
testing.) Similarly, we believe that it is unnecessary, and contrary to
public policy, to expect third party conformity assessment bodies that
have been accredited to conduct that particular test under the 2008
standard, to cease

[[Page 31103]]

testing until they are reaccredited to the 2011 standard. Therefore, in
those situations where the provisions in a revised toy standard are
equivalent or functionally equivalent to the provisions in the earlier
standard, we will continue to accept the accreditation of those third
party conformity assessment bodies, and manufacturers should continue
to have their toys tested and to issue certificates based on such
testing. Third party conformity assessment bodies whose accreditation
we had accepted to the 2008 standard should notify us when they become
accredited to the 2011 standard by submitting an application through
Form 223 on the CPSC Web site, and we will update our listing
accordingly.
9. Phthalates
(Comment 39)--One commenter expressed appreciation for our
inclusion of two test methods for phthalates (a revised CPSC test
method and a Chinese test method) in the notice of requirements, but
they asked us to allow for other ``proven internal test methods.'' The
commenter explained that testing laboratories may modify existing test
methods or develop their own methods for testing for phthalates;
accordingly, they assert that restricting the notice of requirements to
two test methods could result in manufacturers retesting products and
testing backlogs at test laboratories. The commenter said we should
allow other methods ``as long as it can be shown that these are
equivalent to the CSPC methods.'' The commenter said that equivalency
could be shown through side-by-side comparisons with the CPSC method,
method validation data, participation in interlaboratory studies, or
other requirements established by the CPSC.
Another commenter supported our inclusion of the revised CPSC test
method and Chinese test method, but they asked that we consider Health
Canada's test method for total phthalate content in PVC products. The
commenter said that recognizing the Canadian test method would reduce
redundant testing further, by enabling firms to certify compliance with
U.S. and Canadian phthalate requirements using one test.
(Response 39)--We are receptive to considering other test methods
and to adding those methods to a notice of requirements. Indeed, as our
own experience with phthalates testing demonstrates, we have revised or
refined our test method several times and added the Chinese test method
to the notice of requirements for phthalates testing. Parties who
believe that our accreditation criteria should be expanded to include a
specific test method should contact us; or, alternatively, they should
use the petition process at 16 CFR part 1051, to ask us to amend this
rule (assuming that this rule is finalized). The commenter did not
indicate a specific test method that we should allow to be used to
determine phthalate concentrations. Thus, we cannot determine
equivalency to our existing test methods.
With respect to the Canadian test method, we assume that the
commenter is referring to Determination of Phthalates in Polyvinyl
Chloride Consumer Products, Health Canada test method C-34. We share
the desire to reduce the testing burden, where possible, through
harmonization; and we developed CSPC test method CPSC-CH-C1001-09.3
(and its predecessors), specifically including the Health Canada Method
C-34 for determining phthalates, as well as many other methods that
were deemed acceptable as optional means of extraction and analysis of
the phthalates in samples. Thus, tests by a CPSC-accepted testing
laboratory using the C-34 test method are allowed for children's
product certification purposes.
(Comment 40)--Two commenters sought clarification of what materials
need to be tested for phthalates. One commenter referred to our
``Statement of Policy: Testing of Component Parts with Respect to
Section 108 of the CPSIA'' (dated August 7, 2009) (``Statement of
Policy'') to point out that the Statement of Policy gave examples of
materials that do not normally contain phthalates and would not require
testing or certification. The commenter then said that the notice of
requirements caused confusion because a joint statement by a majority
of the Commissioners indicated that the notice of requirements did not
expand the universe of materials or products to be tested or certified
and that the Statement of Policy remained in effect, yet the notice of
requirements did not reflect the Statement of Policy. Thus, the
commenter asked us to revise the notice of requirements to
``specifically list all plastic materials that are known not to contain
phthalates, including, but not limited to, those identified in the
(Statement of Policy) * * * .'' The commenter also provided a list of
more than 30 plastic materials that it said are known not to contain
phthalates.
The second commenter also referred to the Statement of Policy, but
they asked that we revise the Statement of Policy to ``make it clear *
* * that the excluded material list compiled, is not exhaustive and
similar, related or other such materials may not require testing and
may be added in the future.'' The commenter said, however, that ``it is
likely impossible to create an exhaustive list of all materials that
may not include phthalates and therefore may not require testing''
(emphasis in original).
(Response 40)--While we recognize the commenters' desire for
greater clarification with respect to materials that may or may not
contain phthalates, the principal purpose of a notice of requirements
is to establish the criteria under which we will accept the
accreditation of a third party conformity assessment body. In this
instance, the notice of requirements identified the two test methods to
which third party conformity assessment bodies should be accredited,
and any information describing the materials that normally do not
contain phthalates was intended to provide helpful guidance, rather
than establish accreditation criteria. We acknowledge that the
Statement of Policy discussed materials or products that are not known
to contain phthalates and that the notice of requirements referred to
the Statement of Policy and other previous CPSC documents; but that
portion of the notice of requirements was intended to inform interested
parties about those prior CPSC documents and to indicate that they
remain in effect.
With respect to expanding the list of materials that may or may not
contain phthalates and whether such a list should be part of a notice
of requirements, we will consider whether additional guidance on
materials containing or not containing phthalates should be developed.
We decline, however, to include such a list in a notice of requirements
or this rulemaking. Our experience indicates that when a regulation or
document attempts to provide a list of examples, often the list is
construed to be exhaustive or definitive, resulting in multiple
requests to amend the rule or revise the document to add or delete
items from the list. Given our scarce resources, and for the reasons
mentioned in this response, we do not believe it would be prudent to
include as part of this rulemaking, a list of materials containing
phthalates or a list of materials known not to contain phthalates.
(Comment 41)--One commenter discussed Public Law 112-28 and the
exception it created for inaccessible component parts containing
phthalates. In brief, section 5 of Public Law 112-28 amended section
108 of the CPSIA to create an exclusion for ``inaccessible component
parts.'' The commenter sought clear direction from us about ``how the
phthalate standard will apply

[[Page 31104]]

to inaccessible components'' and asked that we ``immediately amend the
Statement of Policy to clarify that inaccessible components are exempt
from the phthalate standard and therefore exempt from third party
testing.''
(Response 41)--We published the Statement of Policy and the notice
of requirements before Public Law 112-28 was enacted. Thus, issues
concerning implementation of the phthalates provision in Public Law
112-28 and revisions to the Statement of Policy are outside the scope
of the notice of requirements and this rulemaking. Further, the notice
of requirements establishes the criteria and process for CPSC
acceptance of accreditation of laboratories for testing children's
products under section 14 of the CPSA. Determination of which component
parts require testing is outside the scope of a notice of requirements.
(Comment 42)--One commenter said that because phthalates are added
intentionally to some plastics, paints, and other materials and are not
ubiquitous environmental contaminants, manufacturers of products
``produced exclusively from materials on the phthalate exclusion list
(or other materials not likely to contain phthalates)'' are ``generally
able to be certain that they are not intentionally adding phthalates
and that phthalate-containing materials are not present in their
factories.'' The commenter asked that we ``explicitly recognize such
knowledge as a reasonable basis for certifying compliance'' with the
phthalates limits and ``allow self-certification by such entities.''
(Response 42)--We decline to revise the notice of requirements or
draft this rule to incorporate the commenter's suggestion. Section
14(a)(2) of the CPSA is clear that, with respect to children's
products, a manufacturer must certify the product based upon testing by
a third party conformity assessment body accredited under section
14(a)(3) of the CPSA. Self-certification based upon a manufacturer's
knowledge would not be consistent with section 14(a)(2) of the CPSA.

E. Miscellaneous Comments

(Comment 43)--One commenter agreed with the notice of requirements
for 16 CFR part 1505, Requirements for Electrically Operated Toys or
other Electrically Operated Articles Intended for Use by Children, and
16 CFR 1500.86(a)(5) (Clacker Balls) and suggested that officials be
sent to manufacturer sites (domestic and foreign) to conduct audits to
see that the tests are performed properly and to ensure that the
manufacturers do perform all steps of the tests submitted by them to
the accredited agencies.
(Response 43)--The commenter may have misunderstood the notice of
requirements. The tests to assess compliance are performed at
laboratories, not at manufacturing sites (unless a manufacturing site
has a firewalled laboratory). If the commenter is referring to
firewalled laboratories or third party laboratories, in general, we
have designated accreditation bodies that are signatories to the ILAC-
MRA to conduct accreditation of third party conformity assessment
bodies to be accepted by the Commission. ILAC-MRA signatories visit
independent and firewalled laboratories during initial assessments and
regular reassessments to assess the laboratory's continued compliance
to the requirements of ISO/IEC 17025:2005. In every assessment and
reassessment, the accreditation body must demonstrate that it has
adequately assessed all of the laboratory's technical competencies and
management systems competencies (as prescribed in ISO/IEC 17025:2005)
associated with its scope of testing.
(Comment 44)--Most notices of requirements included provisions
allowing certificates of compliance to be based on testing performed by
an accredited third party conformity assessment body before the
Commission accepts the laboratory's accreditation. This practice is
sometimes referred to as allowing ``retrospective'' testing. In the
notices of requirements, we prescribed particular circumstances under
which retrospective testing could support a Children's Product
Certificate. For example, we stated that the product should be tested
by a third party conformity assessment body that was, at the time of
product testing, ISO/IEC 17025:2005 accredited by an ILAC-MRA signatory
accreditation body; the accreditation scope in effect at the time of
testing had to include testing to the regulation or test method
identified in the notice; and we placed constraints on how far back in
time the retrospective testing could occur. Initially, we did not allow
any retrospective testing by firewalled laboratories. Later, we allowed
retrospective testing by firewalled laboratories, if the firewalled
laboratory had already been accepted by an order of the Commission for
testing to a test method or regulation specified in an earlier notice
of requirements.
A commenter, in response to an earlier notice of requirements,
supported the position of not allowing any retrospective testing by
firewalled laboratories. This commenter viewed the position of not
allowing any retrospective testing by firewalled laboratories as a way
to reduce any possible conflicts of interest and to ensure that no
undue influence occurred in the certification process.
(Response 44)--If we have already accepted a laboratory as
firewalled, we consider the laboratory to have shown previously that it
has policies and procedures in place consistent with laboratory
independence and impartiality. We will monitor this policy, and, if
necessary, revise it in future rulemakings. We note that because
retrospective testing issues arise only when a third party testing
requirement for a particular rule or standard begins, this proposed
rule would not address retrospective testing.
(Comment 45)--Some commenters argued that the CPSA, as amended by
the CPSIA, does not require third party testing of children's products
that are subject to a regulation of general applicability (e.g., 16 CFR
1610, Standard For the Flammability of Clothing Textiles). In the view
of these commenters, the only children's products for which third party
testing is required are those children's products subject to a
regulation whose reach is limited to children's products (e.g., 16 CFR
1615, 1616, Standard for the Flammability of Children's Sleepwear). One
commenter stated that the safety of children's products subject to
rules of general applicability can be assured via the General
Comformity Certificates that are required for non-children's products
under section 14(a)(1) of the amended CPSA.
Some of the commenters who disagreed that the amended CPSA requires
third party testing of children's products subject to rules of general
applicability asserted that, even if the Commission views the text of
the statute as requiring third party testing for such products, we
should, nevertheless, use our implementing authority under section 3 of
the CPSIA to limit the third party testing requirement to rules of
limited applicability--that is, rules applicable solely to children's
products. Similarly, one commenter urged the Commission to use
authority granted in section 14(b) of the CPSA to ``assess the
necessity of third party testing on a case-by-case basis.''
One commenter argued that we have been inconsistent in describing
what constitutes a ``children's product safety rule.'' The commenter
noted that in the proposed rule on ``Testing and Labeling Pertaining to
Product Certification,'' we stated: ``[c]urrently, the rule on
children's bicycle helmets is the only children's product safety rule
that contains requirements for a reasonable

[[Page 31105]]

testing program.'' 75 FR 28336, 28348 (May 20, 2010). Because the FFA
regulations, such as 16 CFR part 1610, Standard for the Flammability of
Clothing Textiles, contain reasonable testing programs, the commenter
asserted that we must not consider FFA regulations to be children's
product safety rules. The commenter argued that we should offer the
reasonable testing program requirements in 16 CFR part 1610 the same
treatment we have afforded all children's product safety rules with
existing reasonable testing programs (e.g., bicycle helmets).
(Response 45)--Section 14(a)(2) of the CPSA requires manufacturers
and private labelers of a children's product subject to a children's
product safety rule to certify that their children's product complies
with the relevant children's product safety rule. Section 14(f)(1) of
the CPSA defines ``children's product safety rule'' as ``a consumer
product safety rule under this Act or similar rule, regulation,
standard, or ban under any other Act enforced by the Commission,
including a rule declaring a consumer product to be a banned hazardous
product or substance.'' 15 U.S.C. 2063(f)(1).
Thus, the statute defines a ``children's product safety rule'' to
mean a consumer product safety rule. The Commission has taken the
position that the statute requires third party testing to support a
certification of a children's product if that children's product is
subject to a consumer product safety rule. A ``consumer product safety
rule'' becomes a ``children's product safety rule''--not when the
product subject to the rule is limited to children's products--but
rather, when the product subject to the rule includes children's
products.
With regard to the comment that a General Conformity Certificate
would adequately assure the safety of children's products, we again
refer to the statute. Section 14(a)(2) of the CPSA states that a
certification based on third party testing is required for ``any
children's product that is subject to a children's product safety
rule.'' General Conformity Certificates are required for non-children's
products and are not required to be based on third party testing.
However, Public Law 112-28 allows small batch manufacturers to use
alternative testing requirements once the Commission has identified
such testing requirements, or they are allowed an exemption if the
Commission determines that no alternative testing requirement is
available or economically practicable.
As for the comment regarding section 3 of the CPSIA, the statute
gives us some latitude in implementing the CPSIA, but it does not
authorize us to avoid implementing the statute altogether. Courts have
held that an agency's authority to implement a new statute does not
encompass avoiding the statutory obligation itself. See U.S. v.
Markgraf, 736 F.2d 1179, 1183 (7th Cir. 1984) (``An administrative
agency cannot abdicate its responsibility to implement statutory
standards under the guise of determining that inaction is the best
method of implementation.''). See also Friends of the Earth, Inc. v.
EPA, 446 F.3d 140, 145 (DC Cir. 2006) (An administrative agency may not
avoid the plain language of a statute by asserting that its preferred
approach would be better policy; nor can a court ``set aside a
statute's plain language simply because the agency thinks it leads to
undesirable consequences in some applications.'')
Finally, the comment regarding inconsistency in determining what is
a children's product safety rule was submitted in response to the
notice of requirements for clothing textiles, which was published on
August 18, 2010--several months after publication of the proposed rule
on ``Testing and Labeling Pertaining to Product Certification.'' The
publication of the clothing textiles notice of requirements clearly
indicates that the Commission decided that the clothing textiles
standard is a children's product safety rule. In fact, the Commission
reaffirmed its position when it revised the clothing textiles notice of
requirements on April 22, 2011. See 76 FR 22608. The Commission also
issued other FFA-related notices of requirements subsequent to the
publication of the proposed rule on ``Testing and Labeling Pertaining
to Product Certification.'' See, e.g., 75 FR 42311 (July 21, 2011).
Accordingly, we consider the quoted sentence in the preamble to the
proposed rule on ``Testing and Labeling Pertaining to Product
Certification'' to be in error because, as shown by subsequent CPSC
actions, FFA regulations may be children's product safety rules and the
subject of a notice of requirements.
(Comment 46)--Some commenters expressed concern over the cost of
third party testing. One commenter noted, in particular, that for
regulations under the Flammable Fabrics Act (FFA), 15 U.S.C. 1191-1204,
the tests involve hazards, which could result in ``required testing of
additional samples, longer lead times for testing, and added
expenses.'' Some commenters urged a thorough cost-benefit analysis of
the CPSC's rules related to testing and certification, component parts,
and/or the notices of requirements. Some of these commenters argued
that the additional cost of third party testing carries no benefit
because third party testing does not enhance product safety.
Another commenter stated that ``[r]equiring third party testing
further triggers compliance'' with requirements under the two recent
notices of proposed rulemaking (NPRs), Testing and Labeling Pertaining
to Product Certification (to be codified at 16 CFR 1107) (75 FR 28336
(May 20, 2010) and Conditions and Requirements for Testing Component
Parts of Consumer Products (to be codified at 16 CFR 1109) (75 FR 28208
(May 20, 2010)). The commenter opined that ``these regulatory burdens
dilute the focus from * * * ensuring that the product is safe and
compliant with regulatory standards.''
(Response 46)--We are sensitive to testing cost concerns and note
that Public Law 112-28 expressly required us to seek public comment on
opportunities to reduce the cost of third party testing requirements
consistent with assuring compliance with any applicable consumer
product safety rule, ban, standard, or regulation and listed seven
issues for public comment. In the Federal Register of November 8, 2011
(76 FR 65956), we invited comment on the seven issues and on
opportunities to reduce the cost of third party testing requirements.
The comment period for the notice ended on January 23, 2012, and we
will address the comments in a separate proceeding.
However, with respect to conducting cost-benefit analyses for the
rules identified in the comment, the CPSIA did not require us to
conduct such analyses. We also note that we issued final rules on
``Testing and Labeling Pertaining to Product Certification'' (76 FR
69482 (November 8, 2011)) and ``Conditions and Requirements for Relying
on Component Part Testing or Certification, or Another Party's Finished
Product Testing or Certification, to Meet Testing and Certification
Requirements'' (76 FR 69546 (November 8, 2011)). The preamble to the
final rule on ``Testing and Labeling Pertaining to Product
Certification'' summarized and responded to a similar comment on cost-
benefit analyses (see 76 FR at 69484 (comment 2 and response)).
Yet, with respect to the comment that a notice of requirements
somehow ``triggers compliance'' with these two rules, we disagree. A
notice of requirements establishes the criteria under which we will
accept the accreditation of a third party conformity assessment body to
test children's

[[Page 31106]]

products for compliance to a children's product safety rule. Section
14(a)(3)(A) of the CPSA states that the third party testing requirement
applies to any children's product manufactured more than 90 days after
we have established and published the notice of requirements. Section
14(i)(2) of the CPSA creates the obligation for continuing testing. In
any event, the final rule on ``Testing and Labeling Pertaining to
Product Certification'' does not become effective until February 8,
2013. The final rule on ``Conditions and Requirements for Relying on
Component Part Testing or Certification, or Another Party's Finished
Product Testing or Certification, to Meet Testing and Certification
Requirements,'' while effective on December 8, 2011, pertained to the
conditions and requirements under which passing component part test
reports, certification of component parts of consumer products, or
finished product testing or certification procured or issued by another
party, can be used to meet, in whole or in part, the testing and
certification requirements of sections 14(a) and 14(i) of the CPSA. As
such, component part testing as described by that final rule is
voluntary, rather than mandatory.
(Comment 47)--One commenter asserted that requiring manufacturers
of children's clothing textiles subject to the FFA regulations at 16
CFR part 1610, Standard for the Flammability of Clothing Textiles, to
issue certifications based on third party testing ``bypasses the entire
FFA rulemaking process.'' The commenter argued that section 4(b) of the
FFA requires that regulations or amendments to regulations be based on
certain findings that the CPSC has not made, and argued that we have
effectively amended part 1610 to require third party testing of
children's clothing textiles. The commenter stated that when the test
methods in part 1610 were promulgated, and ``[i]n accordance with
Section 4(b) of the FFA,'' the CPSC hosted several meetings attended by
industry and testing representatives, who worked cooperatively to
develop test methods that the representatives and CPSC agreed were
appropriate to assess compliance with the flammability standards. The
commenter stated that the third party testing requirements, along with
the requirements proposed in the testing and labeling and component
parts NPRs, ``entirely undermine this cooperative effort.''
This commenter also asserted that the testing requirements in part
1610 are sufficient for children's products subject to those
regulations, and that requiring third party testing does not provide
additional assurance of the product's ability to pass the applicable
product safety standard. The commenter asked the Commission to hold a
public meeting if we do not agree that the testing regime under part
1610 is sufficient for the industry to demonstrate compliance with the
standard.
(Response 47)--The purpose of the Standard for the Flammability of
Clothing Textiles is to keep dangerously flammable textiles and
garments made of these textiles out of commerce. The standard provides
methods of testing the flammability of clothing and textiles intended
to be used for clothing by classifying fabrics into three classes of
flammability based on their speed of burning. The CPSC has not amended
16 CFR part 1610 by implementing the third party testing requirements
of section 14 of the CPSA.
Section 4 of the FFA prescribes the process for promulgating a
regulation under that statute. Section 4(b) of the FFA requires, in
relevant part, that each FFA ``standard, regulation, or amendment
thereto * * * be based on findings that such standard, regulation, or
amendment thereto is needed to adequately protect the public against
unreasonable risk of the occurrence of fire leading to death, injury,
or significant property damage, is reasonable, technologically
practicable, and appropriate.'' 15 U.S.C. 1193(b). Section 4(b) of the
FFA does not mandate consultation with industry. It requires findings
in support of an FFA regulation. The fact that industry representatives
cooperated with the CPSC when part 1610 was promulgated does not mean
that the CPSC, in implementing section 14(a)(3)(B)(vi) of the CPSA,
must host meetings before issuing a notice of requirements. Therefore,
we decline the commenter's suggestion to hold a public meeting on this
matter.
With regard to the commenter's assertion that tests conducted under
part 1610 sufficiently assure compliance with the standard, and
therefore, third party testing is not necessary, we note that, absent
the CPSIA, a manufacturer of a clothing textile was not required to
conduct the test prescribed by part 1610 at all. If the manufacturer
wished to issue an FFA guaranty that the product complied with part
1610, then the manufacturer had to conduct the tests prescribed by part
1610, but that testing was entirely optional.
(Comment 48)--One commenter stated that the Commission should have
allowed 60 days for the comments to be submitted in response to the
notices of requirements, noting that the TBT Committee has recommended
60-day comment periods. This commenter also observed that the notice of
requirements was effective on publication; thus, there was no
opportunity to comment prior to the notice taking effect.
(Response 48)--The notices of requirements that invited public
comments have all contained a 30-day comment period and have all been
effective upon publication. Nevertheless, this proposed rule provides a
75-day comment period. The public may comment on all aspects of the
proposal, even those parts that were previously included in the notices
of requirements.

F. Comments Considered Out of Scope

Several commenters raised issues that were not present in the
notices of requirements and are not directly relevant to this proposed
rule; such issues, therefore, are outside the scope of this rulemaking.
(Comment 49)--One commenter recommended that we address the
procedures for filing certificates of compliance, including who
``owns'' the certificate and what is the required retention period for
certificates.
(Response 49)--This issue is outside the scope of this rulemaking
because neither the notices of requirements, nor this proposed rule,
concern the requirements or processes for certificates of compliance.
We note that the recently issued final rule, Testing and Labeling
Pertaining to Product Certification (76 FR 69482 (November 8, 2011) (to
be codified at 16 CFR part 1107)), addresses the length of time
manufacturers are required to keep records of certificates of
compliance.
(Comment 50)--One commenter suggested that we specify what will be
considered ``sufficient samples'' of a children's product to submit for
third party testing. The commenter was concerned that different
laboratories would require different sampling schedules, and they
suggested that manufacturers might choose to use laboratories that
require the least onerous sampling schedule. The commenter recommended
that we prescribe a specific, testing schedule based on a statistical
scheme for sample product runs of the children's products. The
commenter also suggested that the number of samples selected for
testing should be based on the size and duration of the production run
of the children's product.
(Response 50)--The proposed rule is limited to establishing the
requirements for conformity assessment bodies in order for their test
results to be used for

[[Page 31107]]

children's product certification purposes. The certifier, not the
laboratory, determines what constitutes a sufficient number of samples
to test for certification. The recently issued final rule on Testing
and Labeling Pertaining to Product Certification (76 FR 69482 (November
8, 2011) (to be codified at 16 CFR part 1107)), addresses sample size
issues to a certain extent, and we also issued a proposed rule
pertaining to ``representative samples'' (76 FR 69586 (November 8,
2011)), pursuant to Public Law 112-28.
(Comment 51)--One commenter stated: ``component or raw material
testing is another major concern,'' and they urged that ``allowing for
reasonable component testing is a critical need to avoid a crushing
financial burden on small businesses.''
(Response 51)--This rulemaking is limited to the requirements
related to the accreditation of third party conformity assessment
bodies. Whether and under what circumstances component parts of
children's products may be third party tested separately in support a
certificate of compliance is not related to the criteria and process
for CPSC acceptance of the accreditation of third party conformity
assessment bodies. The recently issued final rule, Conditions and
Requirements for Relying on Component Part Testing or Certification, or
Another Party's Finished Product Testing or Certification, to Meet
Testing and Certification Requirements (76 FR 69546 (November 8, 2011)
(to be codified at 16 CFR part 1109)), should address the commenter's
concerns.
(Comment 52)--Some commenters described their opinions concerning
whether third party testing of children's products for lead content
should be required. Overall, the commenters supported third party
testing in this context.
(Response 52)--Section 101 of the CPSIA established the lead
content limits for children's products. Section 14(a)(2)(A) of the CPSA
requires manufacturers of children's products to submit samples of a
children's product to a third party conformity assessment body for
testing as a basis for certifying the children's product. These
comments refer to the statutory requirements and are beyond the scope
of this proposed rulemaking.
(Comment 53)--In response to the notice of requirements for
accreditation of third party conformity assessment bodies to assess
conformity of youth products under the CPSC regulation on ATVs (16 CFR
part 1420), one commenter urged that children younger than the age at
which one can legally drive traditional motor vehicles should not be
allowed to operate ATVs. In the view of this commenter, ATVs have
become a serious public health concern for children. The commenter
described study findings and statistics in support of his view.
(Response 53)--The notice of requirements related to ATVs provided
the criteria and processes for CPSC acceptance of the accreditation of
laboratories that will be able to conduct the third party tests of
youth ATVs that may support manufacturers' certificates of compliance
with 16 CFR part 1420. Therefore, the question of whether children
should be allowed to operate ATVs is beyond the scope of the ATV notice
of requirements and the proposed rule.
(Comment 54)--Several commenters remarked on the cost of complying
with the lead content requirements in the context of small businesses
selling handcrafted items. One commenter remarked that handcrafted,
one-of-a-kind items cannot each be destructively tested. The commenter
suggested that our regulations mirror California's Lead-Containing
Jewelry Law, AB 2901. Another commenter asked if the regulations had
exceptions to the testing requirements. Another commenter stated that
the testing costs will tend to decrease consumer options because small
manufacturers will not be able to stay in business. The commenter's
main concern was that all ``units'' of children's items must be tested
for lead content and phthalates, and that relying on testing by
suppliers is not sufficient. The commenter offered the following
suggestions:
1. Waive the testing requirements for small-volume manufacturers,
such as those with less than $1 million in revenue in the United
States.
2. If a waiver is not possible, provide free testing to small
businesses that produce children's products.
3. Allow third party certification of components from manufacturers
to be used as a basis for a finished product certificate.
(Response 54)--The scope of this proposed rule is limited to the
requirements related to the accreditation of third party conformity
assessment bodies. This rulemaking does not address the requirements
related to the testing and certification of consumer products.
Therefore, these comments are beyond the scope of this proposed rule.
Additionally, one provision in Public Law 112-28 directs us to seek
public comment on seven specific issues, including:

The extent to which modification of the certification
requirements may have the effect of reducing redundant third party
testing by or on behalf of two or more importers of a product that
is substantially similar or identical in all material respects;
The extent to which products with a substantial number
of different components subject to third party testing may be
evaluated to show compliance with an applicable rule, ban, standard,
or regulation by third party testing of a subset of such components
selected by a third party conformity assessment body;
The extent to which manufacturers with a substantial
number of substantially similar products subject to third party
testing may reasonably make use of sampling procedures that reduce
the overall test burden without compromising the benefits of third
party testing; and
Other techniques for lowering the cost of third party
testing consistent with assuring compliance with the applicable
consumer product safety rules, bans, standards, and regulations.

Recently, we published a Federal Register notice seeking public comment
on issues regarding reducing the testing burden for children's product
certifiers. See Application of Third Party Testing Requirements;
Reducing Third Party Testing Burdens (76 FR 69596 (November 8, 2011)).
Public Law 112-28 also requires us to review the public comments, and
it states that we may prescribe new or revised third party testing
regulations if we determine that such regulations will reduce third
party testing costs consistent with assuring compliance with the
applicable consumer product safety rules, bans, standards, and
regulations.
(Comment 55)--One commenter raised concerns that the third party
testing requirements would create a competitive advantage for the
larger firms and drive many small businesses out of the market. The
commenter recommended that the law (presumably the CPSIA) be amended to
focus on manufacturers directly linked to the production of unsafe
products for children and penalize them, as opposed to penalizing the
small business community.
(Response 55)--The commenter may have misunderstood the purpose of
a notice of requirements. A notice of requirements establishes the
accreditation requirements for laboratories to test for compliance to
specific rules, bans, standards, or regulations. It does not establish
requirements for manufacturers, other than establishing a date by which
children's products must be certified based on third party testing
results. Therefore, issues pertaining to statutory amendments, the
effects of third party testing on small businesses, and penalties for
manufacturers, are all beyond the scope of this proposed rule.

[[Page 31108]]

As discussed in the response to Comment 49, we have published a
notice in the Federal Register (76 FR 69596) seeking public comment on
issues regarding reducing the testing burden for children's product
certifiers. Further, Public Law 112-28 created a new section 14(i)(4)
of the CPSA to provide for special rules for small batch manufacturers.
The provision contemplates the possible development of alternative
testing requirements for ``covered products'' made by ``small batch
manufacturers'' and defines the terms ``covered product'' and ``small
batch manufacturer.'' The provision also provides for possible
exemptions of small batch manufacturers from the third party testing
requirements and imposes certain limits on third party testing
requirements.

IV. Description of the Proposed Rule

The proposed rule would consist of four subparts. Subpart A,
``Purpose and Definitions,'' is created by the audit final rule
published elsewhere in this issue of the Federal Register. This
proposed rule would add to subpart A, a section describing the purpose
of part 1112; it would amend two definitions contained in the audit
final rule; and it would add several new definitions. In addition, the
audit final rule reserved a subpart B in part 1112; this proposed rule
would create subpart B, which would contain the principal requirements
for third party conformity assessment bodies, including how a
laboratory may obtain CPSC acceptance of its accreditation. Subpart C
addresses audits, and it is the core of the audit final rule (published
elsewhere in this issue of the Federal Register). The proposed rule,
however, would add a provision to subpart C, addressing the timing of
audits. The proposed rule also would create a subpart D, addressing
adverse actions that we may take against CPSC-accepted third party
conformity assessment bodies. Finally, the proposed rule would make
limited changes to Sec. 1118.2, the Commission's regulation on the
conduct and scope of inspections, to conform with part 1112.
At the outset, we note that section 14(f)(2)(D) of the CPSA
requires that the acceptance of the accreditation of a firewalled
laboratory occur by order of the Commission. Consistent with this
provision, the Commission considers that any removal of the acceptance
of the accreditation of a firewalled laboratory (whether by suspension
or withdrawal) also must occur by order of the Commission. The
Commission may delegate other functions and powers described in this
part to CPSC staff, under 16 CFR Sec. 1000.11. (Due to this
distinction between functions that the Commission as a body of
appointed Commissioners must discharge, and other functions that the
agency may discharge via staff activity, from this point forward in
this preamble, we attempt to distinguish between the Commission as a
body (``Commission'') and the CPSC as an agency (``CPSC'').)

A. Subpart A--Purpose and Definitions

1. Proposed Sec. 1112.1--Purpose
Proposed Sec. 1112.1 would describe the major topics addressed in
part 1112. It would note that the part defines the term ``third party
conformity assessment body'' and describes the types of third party
conformity assessment bodies whose accreditations are accepted by the
CPSC to test children's products under section 14 of the CPSA. It would
note that part 1112 describes the requirements and procedures for
becoming a CPSC-accepted third party conformity assessment body; the
audit requirement applicable to third party conformity assessment
bodies; how a third party conformity assessment body may voluntarily
discontinue participation as a CPSC-accepted third party conformity
assessment body; the grounds and procedures for withdrawal or
suspension of CPSC acceptance of accreditation of a third party
conformity assessment body; and how an individual may submit
information alleging grounds for adverse action.
2. Proposed Sec. 1112.3--Definitions
The proposed rule would add a sentence preceding the definitions,
to clarify that the definitions in this section apply for purposes of
this part.
(i) Revised Definitions
Proposed Sec. 1112.3 would amend two definitions that appear in
the audit final rule, which published elsewhere in this issue of the
Federal Register. The two definitions to be amended are:
Audit: An audit of a CPSC-accepted laboratory consists of two
parts: the reassessment portion, which is conducted by the
accreditation body, and the examination portion, which is conducted by
the CPSC. Currently, the definition of audit describes the examination
portion as:

The resubmission of the ``Consumer Product Conformity Assessment
Body Acceptance Registration Form'' (CPSC Form 223) by the third
party conformity assessment body and the Consumer Product Safety
Commission's (``CPSC's'') examination of the resubmitted CPSC Form
223. If the third party conformity assessment body is owned,
managed, or controlled by a manufacturer or private labeler (also
known as a ``firewalled'' conformity assessment body) or is a
government-owned or government-controlled conformity assessment
body, the CPSC's examination may include verification to ensure that
the entity continues to meet the appropriate statutory criteria
pertaining to such conformity assessment bodies.

To this portion of the definition, the proposed rule would add the
words, ``and accompanying documentation'' twice, after each mention of
the CPSC Form 223. The proposed rule would delete the second sentence
and replace it with the following two sentences:

Accompanying documentation includes the baseline documents
required of all applicants in 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).

Documents beyond the baseline documents are required of firewalled and
governmental applicants so that the CPSC's examination may include
verification to ensure that the entity continues to meet the
appropriate statutory criteria pertaining to such third party
conformity assessment bodies. These changes would clarify which
materials must be submitted at audit. As the purpose of the audit is to
confirm that the laboratory continues to meet the requirements of CPSC
acceptance, all laboratories would be required to submit the baseline
documentation.
CPSC: The audit final rule defines ``CPSC'' to mean the U.S.
Consumer Product Safety Commission. The proposed rule would discuss
certain tasks that must be accomplished by the actual Commission body,
as opposed to the CPSC as an agency. Thus, to distinguish between the
Commission, as a body, as opposed to the agency, as a whole, the
proposed rule, for purposes of part 1112 only, would revise the
definition of ``CPSC'' to mean the U.S. Consumer Product Safety
Commission as an agency.
(ii) New Definitions
Proposed Sec. 1112.3 would create the following nine definitions:
Accept accreditation: The proposed rule would define this term
consistent with its use in section 14 of the CPSA. See, e.g., 15 U.S.C.
2063(e)(1). It would mean that the CPSC has positively disposed of an
application by a third party conformity assessment body to test
children's products pursuant to a particular children's product safety
rule, for purposes of the testing required in section 14 of the CPSA.
Commission: We would define ``Commission'' to mean the body of
Commissioners appointed to the U.S.

[[Page 31109]]

Consumer Product Safety Commission. In contrast, the agency as a whole
will be referred to, in this part, as the CPSC.
CPSA: We would define this acronym to mean the Consumer Product
Safety Act, 15 U.S.C. 2051-2089.
Notice of requirements: We would define this term consistent with
how it is used in section 14 of the CPSA and with how we have used the
term to date. It would mean a publication that provides the minimum
qualifications necessary for a laboratory to become CPSC-accepted to
test children's products pursuant to a particular children's product
safety rule.
Scope: The testing and accreditation community typically use the
word ``scope'' or ``scope of accreditation'' to mean the entire list of
testing services for which a laboratory has been granted accreditation,
which usually includes many test methods and standards beyond those
related to CPSC rules. For purposes of this part, we would define this
term slightly differently. In part 1112, ``scope'' would mean the range
of particular children's product safety rules and/or test methods to
which a laboratory has been accredited and for which it may apply for
CPSC acceptance of its accreditation.
Suspend: The proposed rule would define this term consistent with
its use in section 14(e) of the CPSA, which this proposed rule would
implement. ``Suspend'' would mean that the CPSC has removed its
acceptance, for purposes of the testing of children's products required
in section 14 of the CPSA, of a laboratory's accreditation due to the
laboratory's failure to cooperate in an investigation under this part.
Third party conformity assessment body: We propose to define this
term to mean a testing laboratory.
We developed this definition from the use of the term ``third party
conformity assessment body'' in section 14 of the CPSA. The CPSA
contains a lengthy definition of this term, which includes the
conditions placed on governmental and firewalled laboratories. For ease
of understanding, we propose to define the term more succinctly, but
our definition is consistent with the term's use throughout the CPSA.
In particular, we note that the statutory definition of this term
states that a governmental laboratory that satisfies certain conditions
may be considered a third party conformity assessment body. The
statutory definition also states that a conformity assessment body that
is owned, managed, or controlled by a manufacturer or private labeler
may be accepted as a third party conformity assessment body by the
Commission if it satisfies certain conditions. Section 14 of the CPSA
consistently refers to CPSC-accepted laboratories collectively as
``third party conformity assessment bodies.''
We are aware that the term ``third party conformity assessment
body,'' by virtue of the words ``third party,'' commonly refers to a
laboratory that is entirely independent of the entity supplying the
product to be tested and independent of any entity interested in the
product. However, because this rule implements section 14 of the CPSA,
which refers to all CPSC-accepted laboratories as ``third party
conformity assessment bodies,'' the proposed rule would follow the
statute's convention on this point.
We also are aware that, in the laboratory industry, the term
``third party conformity assessment body'' is understood to include
entities other than testing laboratories. However, the proposed rule
would use the term as it is used in the CPSA, which is as a testing
laboratory.
Finally, we note that, in the preamble to this rule, for ease of
reference, and for the convenience of the reader, we use the word
``laboratory'' interchangeably with ``third party conformity assessment
body.'' In the regulatory text, for clarity, we only use the full term,
``third party conformity assessment body.''
Undue influence: We have developed a definition for undue influence
after reviewing similar definitions used by other federal agencies and
some laboratories, and with the goal of having a broad enough
definition that the myriad sources and methods of undue influence that
could arise in this context would be captured by the definition. The
proposed rule would define ``undue influence'' to mean that a
manufacturer, private labeler, governmental entity, or other interested
party affects a laboratory, such that commercial, financial, and other
pressures compromise the integrity of its testing processes or results.
Withdraw: The proposed rule would define this term consistent with
its use in section 14(e) of the CPSA. The proposal would define
``withdraw'' to mean that the CPSC removes its prior acceptance of a
laboratory's accreditation pursuant to a particular children's product
safety rule for purposes of the testing of children's products required
in section 14 of the CPSA.

B. Subpart B--General Requirements Pertaining to Third Party Conformity
Assessment Bodies

Proposed subpart B would establish the foundation for the CPSC
third party conformity assessment body program with respect to basic
topics, such as when and how a laboratory may apply to the CPSC for
acceptance of its accreditation, and how a laboratory can voluntarily
discontinue its participation with the CPSC. The proposed subpart also
would define the three types of laboratories, create various
obligations for CPSC-accepted laboratories, such as recordkeeping
responsibilities, and institute certain limitations, such as limits on
the ability to subcontract test work conducted, on CPSC-accepted
laboratories. Proposed subpart B also would include details on how we
will respond to each application and how we will publish information
concerning which laboratories have had their accreditation accepted.
1. Proposed Sec. 1112.11--What are the types of third party conformity
assessment bodies?
Proposed Sec. 1112.11 would describe, for purposes of part 1112,
the three types of third party conformity assessment bodies:
Independent, firewalled, and governmental. Proposed Sec. 1112.11(a)
would describe an ``independent laboratory'' as a third party
conformity assessment body that is neither owned, managed, or
controlled by a manufacturer or private labeler of a children's product
to be tested by the laboratory, nor owned or controlled, in whole or in
part, by a government.
Section 14(f)(2) of the CPSA defines a ``firewalled third party
conformity assessment body'' as one that is owned, managed, or
controlled by a manufacturer or private labeler. We note that section
14(f)(2)(D) of the CPSA clearly states that a firewalled laboratory is
one ``owned, managed, or controlled by a manufacturer or private
labeler (emphasis added).'' Therefore, we do not consider a laboratory
to be firewalled if the laboratory owns, manages, or controls a
manufacturer or private labeler.
We note that, for purposes of determining whether a laboratory is
considered firewalled, we propose to interpret ``manufacturer'' to
include a trade association. Like a manufacturer, an association of
manufacturers is in a position to exert undue influence on a laboratory
owned, managed, or controlled by the association. The undue influence
may come in the form of an expectation that special

[[Page 31110]]

consideration will be given to the test results of association members
or reports of attempted undue influence by an association member are
discouraged.
The proposed rule would consider a laboratory ``firewalled'' if: it
is owned, managed, or controlled by a manufacturer or private labeler
of a children's product; that children's product is subject to a CPSC
children's product safety rule which the laboratory requests CPSC
acceptance to test; and the laboratory intends to test such children's
product made by the owning, managing, or controlling entity for the
purpose of supporting a Children's Product Certificate. A laboratory
would be considered to be ``owned, managed, or controlled'' by a
manufacturer or private labeler if one (or more) of four
characteristics apply.
The first circumstance that would result in a laboratory being
characterized as firewalled is closely related to the method we have
been using in the notices of requirements to identify firewalled
laboratories. Under proposed Sec. 1112.11(b)(1)(ii)(A), if the
manufacturer or private labeler of the children's product holds a 10
percent or greater ownership interest, whether direct or indirect, in
the laboratory, the laboratory would be considered firewalled. In this
context, indirect ownership interest would be calculated by successive
multiplication of the ownership percentages for each link in the
ownership chain.
We propose to maintain the 10 percent threshold ownership amount
because it is our estimation that a manufacturer or private labeler
that possesses a less than 10 percent ownership interest in a
laboratory, and that does not otherwise exercise management or control
of the laboratory, presents a low risk of exercising undue influence
over the laboratory. In addition, our experience using this threshold
over the past three years indicates that applicants easily understand
it and have been able to supply such information. We note that the
Federal Communications Commission also uses a 10 percent ownership
threshold in its ownership disclosure requirements for applications.
See 47 CFR 1.2112.
The difference in the proposed rule from current practice is the
addition of indirect ownership. Proposed Sec. 1112.11(b)(1)(ii)(A)
would include indirect ownership because an entity that owns a
manufacturer or private labeler which, in turn, owns a laboratory, has
the same potential for conflict of interest concerning the independence
of the testing process as a manufacturer or private labeler who owns a
laboratory directly. We propose to determine whether an indirect owner
holds a 10 percent interest in a laboratory by multiplying the
percentages of ownership in each owning entity. For example, if Company
X is a manufacturer of a children's product and owns 25 percent of the
stock in Company Y, and Company Y owns 50 percent of Laboratory Z, then
Company X would own (indirectly) 12.5 percent of Laboratory Z (0.25 x
0.50 = 0.125). Because Company X holds more than a 10 percent indirect
ownership interest in Laboratory Z, if Laboratory Z wishes to apply to
the CPSC for acceptance of its accreditation to test children's
products made by Company X, Laboratory Z would be considered an
applicant for firewalled status. This approach to calculating indirect
ownership is used by some other Federal agencies. See, e.g., 42 CFR
420.202 (Medicare regulations concerning ownership or control
disclosure requirements); 47 CFR 1.2112 (FCC regulations concerning
ownership disclosure requirements).
The second circumstance, in proposed Sec. 1112.11(b)(1)(ii)(B),
that would signify a firewalled laboratory is when the laboratory and a
manufacturer or private labeler of the children's product are owned by
the same parent entity. In this instance, the manufacturer would not be
a 10 percent owner of the laboratory, either directly or indirectly;
but the interests of both entities would converge in a common parent.
In such a case, the parent company would hold the interests of the
manufacturer, and the laboratory should be properly firewalled to
ensure its testing processes are independent.
The third circumstance, in proposed Sec. 1112.11(b)(1)(ii)(C),
which would result in firewalled status is when a manufacturer or
private labeler of the children's product has the ability to appoint a
majority of the laboratory's senior internal governing body (including,
but not limited to, a board of directors); the ability to appoint the
presiding official (including, but not limited to, the chair or
president) of the laboratory's senior internal governing body; and/or
the ability to hire, dismiss, or set the compensation level for
laboratory personnel. The ability to appoint the president or a
majority of the senior internal governing body, or to make personnel
decisions, indicates management and/or control of the laboratory.
The fourth circumstance, at proposed Sec. 1112.11(b)(1)(ii)(D),
that would result in firewalled status is when the laboratory is under
a contract to a manufacturer or private labeler of the children's
product and the contract explicitly limits the services the laboratory
may perform for other customers and/or explicitly limits which or how
many other entities may also be customers of the laboratory. In this
instance, the terms of the contract would grant the manufacturer or
private labeler such a significant interest in the work of the
laboratory that the Commission would consider that interest to be
controlling.
To date, the list of CPSC-accepted laboratories maintained on the
CPSC Web site has not indicated which laboratories have firewalled
status. Because this proposed rule would expand the definition of
``firewalled laboratory'' to include laboratories not only owned, but
also those managed or controlled by a manufacturer or private labeler,
we invite comments on whether the Web site listing should include an
indication of firewalled status. Do manufacturers looking for a
laboratory via the CPSC Web site want to know whether a laboratory is
firewalled? Are there other interests in identifying a laboratory as
firewalled on our Web site? Do laboratories with firewalled status
perceive disadvantages to being identified as such?
According to section 14(f)(2)(B) of the CPSA, a ``governmental''
laboratory is one ``owned or controlled in whole or in part by a
government.'' Proposed Sec. 1112.11(c) would implement that
definition. For purposes of this part, we would consider ``government''
to include any unit of a national, territorial, provincial, regional,
state, tribal, or local government. ``Government'' would include
domestic, as well as foreign governmental entities.
Proposed Sec. 1112.11(c) would consist of six characteristics, any
one of which triggers governmental laboratory status. The legal
framework for government ownership or control of a laboratory will vary
across the world's jurisdictions, as will the potential for undue
influence as a direct or indirect result of that government's ownership
or control. The government of the laboratory in question may exercise
control, based on the rule of law or otherwise, out of proportion to
its ownership stake in a laboratory or to the laboratory's official
independent status within the government organizational structure--a
situation that Congress foresaw when it specified ``in whole or in
part'' in section 14(f)(2)(B) of the CPSA. For that reason, the
proposed rule would describe those ways that a government could
reasonably be seen to have a means of operational control over a
laboratory that has a financial or

[[Page 31111]]

organizational connection to that government.
The first characteristic that would indicate governmental status is
that a governmental entity holds a 1 percent or greater ownership
interest, whether direct or indirect, in the laboratory. Selecting 1
percent as an ownership threshold is a practical matter of selecting
the smallest whole number as an expression of ownership ``in part.''
Indirect ownership interest would be calculated for these purposes in
the same way as we propose to calculate it for purposes of indirect
ownership of a firewalled laboratory, which is by successive
multiplication of the ownership percentages for each link in the
ownership chain. For example, if Government A is a joint venture
partner with Company B, such that Government A owns 20 percent of
Company B, and Company B holds a 10 percent interest in Laboratory C,
then Government A would indirectly own 2 percent of Laboratory C.
Therefore, Laboratory C is considered a governmental laboratory.
The second characteristic that would indicate governmental status
is that a governmental entity provides any direct financial investment
or funding (other than fee for work) to the laboratory. We consider
that this circumstance would trigger governmental status because
operational control of an enterprise may be affected by control or
influence over its resources.
The third proposed governmental characteristic would mirror the
third characteristic of firewalled status: a governmental entity has
the ability to appoint a majority of the laboratory's senior internal
governing body (such as but not limited to a board of directors); the
ability to appoint the presiding official of the laboratory's senior
internal governing body (such as but not limited to chair or
president); and/or the ability to hire, dismiss, or set the
compensation level for laboratory personnel. The ability to appoint the
president or a majority of the senior internal governing body, or to
make personnel decisions, indicates control, at least in part, of the
laboratory.
The fourth characteristic, at proposed Sec. 1112.11(c)(4), would
consider a laboratory to be governmental if any of the laboratory's
management or technical personnel are government employees. This direct
involvement by the government in the operation of the laboratory would
represent control in part.
The fifth characteristic, at proposed Sec. 1112.11(c)(5), which
would signify a governmental laboratory is if the laboratory has a
subordinate position to a governmental entity in its external
organizational structure. We would except the circumstance where the
only relationship the laboratory has with the governmental entity is
that of a regulated entity. In that sense, most laboratories in
existence are associated administratively with a government, and we do
not consider the existence of governmental regulations applicable to a
laboratory to establish governmental control. (For example, the fact
that a laboratory may be subject to certain employment requirements or
subject to tax regulations does not establish that the laboratory is a
government laboratory.) Instead, we intend to consider those
laboratories that are organizationally a part of, or formally linked
to, the government to be governmental laboratories. In those cases,
even if the government is not an owner, it has the means of controlling
the laboratory.
Finally, the sixth characteristic, at proposed Sec. 1112.11(c)(6),
would list situations in which government control of a laboratory is
evident via the authority the government has over the laboratory. We
propose that if a government can determine, establish, alter, or
otherwise affect the laboratory's testing outcomes, its budget or
financial decisions, its organizational structure or continued
existence, or whether the laboratory may accept particular offers of
work, then the laboratory would be considered governmental.
2. Proposed Sec. 1112.13--How does a third party conformity assessment
body apply for CPSC acceptance?
Proposed Sec. 1112.13 would describe how a third party conformity
assessment body may apply for CPSC acceptance of its accreditation. We
propose to use the authority granted in section 14(a)(3)(C) of the CPSA
to designate signatories to the ILAC-MRA to accredit laboratories to
ISO/IEC 17025:2005. For a laboratory to be able to conduct tests under
section 14 of the CPSA, however, the CPSC must affirmatively accept
that laboratory's accreditation.
Proposed Sec. 1112.13(a) would relate the initial baseline
requirements applicable to all laboratory applicants. The proposed
baseline requirements are substantially similar to the baseline
requirements in the notices of requirements, although the application
form (CPSC Form 223) would be revised to correspond with other changes
in the proposed rule. The first baseline requirement would be a
completed application, CPSC Form 223. On a revised CPSC Form 223, the
laboratory would attest to certain facts and characteristics concerning
its business, which would determine whether the applicant is
independent, firewalled, or governmental. If the laboratory is
considered firewalled or governmental, the online CPSC Form 223 will
prompt the laboratory to submit the requisite additional documentation.
On a revised CPSC Form 223, the laboratory also would attest that it
has read, understood, and agrees to the regulations in this part.
Proposed Sec. 1112.13(a) also would require that the laboratory update
its CPSC Form 223 whenever any information previously supplied on the
form changes.
The second baseline criteria would be an accreditation certificate.
Each laboratory would be required to be accredited to ISO/IEC Standard
17025:2005, ``General requirements for the competence of testing and
calibration laboratories.'' Because we are proposing to require
compliance with a standard that is already published, we must
incorporate that standard by reference into these regulations. The
proposed rule would note that the Director of the Federal Register
approved the incorporation by reference of ISO/IEC 17025:2005 in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. It would note that
readers may obtain a copy of ISO/IEC 17025:2005 from the International
Organization for Standardization (ISO), 1, ch. de la Voie-Creuse, Case
postale 56, CH-1211 Geneva 20, Switzerland; Telephone +41 22 749 01 11,
Fax +41 22 733 34 30; http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883. Readers may also inspect a copy at the
Office of the Secretary, U.S. Consumer Product Safety Commission, Room
820, 4330 East West Highway, Bethesda, MD 20814, telephone 301-504-
7923, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741- 6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
The proposed rule would require accreditation by an accreditation
body that is a signatory to the ILAC-MRA. All laboratories also would
be required to furnish their statement of scope, and it would have to
clearly identify the CPSC rule(s) and/or test method(s) for which CPSC
acceptance is sought.
Proposed Sec. 1112.13(b) would state the additional requirements
for firewalled laboratories. Section 14(f)(2)(D) of the CPSA mandates
that a laboratory only may be accepted as firewalled if the Commission,
by order, finds that:

[[Page 31112]]

(i) [Acceptance] of the conformity assessment body would provide
equal or greater consumer safety protection than the manufacturer's
or private labeler's use of an independent third party conformity
assessment body; and
(ii) [T]he conformity assessment body has established procedures
to ensure that--
(I) [I]ts test results are protected from undue influence by the
manufacturer, private labeler, or other interested party;
(II) [T]he Commission is notified immediately of any attempt by
the manufacturer, private labeler or other interested party to hide
or exert undue influence over test results; and
(III) [A]llegations of undue influence may be reported
confidentially to the Commission.

15 U.S.C. 2063(f)(2)(D).
To evaluate whether a laboratory satisfies these criteria, the
proposed rule would require that a laboratory seeking CPSC-accepted
firewalled status submit copies of various documents to the CPSC.
First, the proposed rule would require the laboratory to submit copies
of certain established policies and procedures. The laboratory would
need to submit its policies and procedures that explain how test
results are protected from undue influence by the manufacturer, private
labeler, or other interested party. The purpose of reviewing such
documents would be to assess whether the laboratory has established the
necessary written procedures to preserve its independence from the
manufacturer or private labeler. We also would require the laboratory
to submit copies of established policies and procedures, indicating
that the CPSC will be notified immediately of any attempt to hide or
exert undue influence over test results, and policies and procedures
explaining that an allegation of undue influence may be reported
confidentially to the CPSC. The purpose of reviewing these documents is
to ensure that the laboratory has written procedures in place that
address when and how the CPSC will be notified of any attempt at undue
influence.
Second, the proposed rule would require an applicant laboratory
seeking firewalled status to supply copies of training documents,
including a description of the training program content, showing how
employees are trained on the three policies just described. We propose
to require this training annually. If an employee receives such
training only once, the employee may forget the information over the
course of time, or the importance of the information would not be
reinforced. In addition, the issue of staff turnover presents a risk
that new employees would not receive the training. An annual training
requirement would address these risks.
Third, proposed Sec. 1112.13(b)(2) would require training records
listing the staff members who received the training and bearing their
signatures. The training records would include training dates,
location, and the name and title of the individual providing the
training. We propose to require the submission of these training-
related documents so that we may assess whether the laboratory is
sufficiently and effectively communicating to its employees the need to
protect the testing process from undue influence, and that the
employees may notify the CPSC immediately and confidentially of any
attempt by a manufacturer, private labeler, or other interested party
to hide or exert undue influence over test results.
Proposed Sec. 1112.13(b)(2)(iv) and (v) would require firewalled
laboratory applicants to submit two organizational charts. One chart
would be an organizational chart(s) of the laboratory itself. It would
include the names of all personnel, both temporary and permanent, and
their reporting relationship within the laboratory. The other
organizational chart would identify the reporting relationships of the
laboratory within the broader organization (using both position titles
and staff names). Finally, we also would require a list of all
laboratory personnel with reporting relationships outside of the
laboratory. The list would identify the name and title of the relevant
laboratory employee(s) and the names, titles, and employer(s) of all
individuals outside of the laboratory to whom they report. The
organizational charts and the list of employees with outside reporting
relationships would help us determine the degree to which the
laboratory is independent of the manufacturer or private labeler.
If the Commission determines that the firewalled-specific documents
indicate that the laboratory has sufficient safeguards against and
procedures concerning undue influence in place, and the laboratory
satisfies the baseline criteria, including ISO/IEC 17025:2005
accreditation by an ILAC-MRA signatory body, then the Commission will
consider that the applicant laboratory would provide equal consumer
safety protection than the manufacturer's or private labeler's use of
an independent laboratory.
Proposed Sec. 1112.13(c) would state the additional accreditation
requirements applicable to governmental laboratories. Section
14(f)(2)(B) of the CPSA mandates that the Commission may accept the
accreditation of a governmental laboratory if:

(i) [T]o the extent practicable, manufacturers or private
labelers located in any nation are permitted to choose conformity
assessment bodies that are not owned or controlled by the government
of that nation;
(ii) [T]he entity's testing results are not subject to undue
influence by any other person, including another governmental
entity;
(iii) [T]he entity is not accorded more favorable treatment than
other third party conformity assessment bodies in the same nation
who have been accredited under [section 14];
(iv) [T]he entity's testing results are accorded no greater
weight by other governmental authorities than those of other
accredited third party conformity assessment bodies accredited under
[section 14]; and
(v) [T]he entity does not exercise undue influence over other
governmental authorities on matters affecting its operations or on
decisions by other governmental authorities controlling distribution
of products based on outcomes of the entity's conformity
assessments.

15 U.S.C. 2063(f)(2)(B).
To evaluate whether a laboratory satisfies these criteria, the
proposed rule would require a governmental laboratory to submit a
description that can be in the form of a diagram, which illustrates
relationships with other entities, such as government agencies and
joint venture partners. Such a document would give us basic information
concerning the nature of the relationship between the laboratory and
the government. In addition, we would require the laboratory and the
relevant governmental entity to each respond to a questionnaire. The
questionnaires are designed to elicit information related to the five
statutory criteria.
Third, we would require a governmental laboratory to submit a copy
of an executed memorandum that addresses undue influence. The purpose
of the memorandum is to provide affirmative and continuous
communication to the laboratory staff concerning the management
policies regarding undue influence, and the staff's responsibilities in
implementing the policies. The memorandum would be on company
letterhead, from the senior management of the laboratory, and directed
to all laboratory staff. The memorandum must be in the primary written
language used for business communications in the area in which the
laboratory is located, and, if that language is not English, then the
laboratory must provide an English translation. The memorandum would
need to be displayed prominently at the laboratory for as long as the
laboratory is accepted by the CPSC.

[[Page 31113]]

The proposed rule would require the memorandum to state certain
policies. It would require that the memorandum state that the
laboratory's policy is to reject undue influence. We also would have
the memorandum require employees to report immediately, to their
supervisor or some other designated laboratory official, any attempt at
undue influence. It would require the memorandum to state that the
laboratory will not tolerate violations of the undue influence policy.
The fourth and final document to be required from governmental
laboratory applicants would be an attestation. We would require a
senior official of the governmental laboratory, who has the authority
to make binding statements of policy on behalf of the laboratory, to
attest to several statements related to the application, including that
the laboratory does not receive and will not accept favorable treatment
from any governmental entity with regard to products for export to the
United States that are subject to CPSC jurisdiction. Among other
things, the senior official of the governmental laboratory would have
to attest that the information in the laboratory's application
continues to be accurate, unless the laboratory notifies the CPSC
otherwise. Thus, the senior official would be acknowledging a duty to
inform the CPSC if any information submitted as part of the application
has changed. As another example, the proposal would require the senior
official to attest that the laboratory will not conduct CPSC tests in
support of a Children's Product Certificate for products produced by a
governmental entity that has any ownership or control of the
laboratory. The attestation gives us an additional level of assurance
that is unique to intergovernmental relationships.
Finally, the proposed rule would state that, if our approval of a
governmental laboratory application is dependent upon a recently
changed circumstance in the relationship between the laboratory and the
governmental entity, and/or a recently changed policy of the related
governmental entity, we may require the relevant governmental entity to
attest to the details of the new relationship or policy. Such a
provision would enable us to verify the changed circumstance prior to
our acceptance of the governmental laboratory.
Proposed Sec. 1112.13(d) would state that if a laboratory
satisfies both the criteria for governmental status and the criteria
for firewalled status, such a laboratory would be required to apply
under both categories.
Proposed Sec. 1112.13(e) would require that all application
materials be in English. Proposed Sec. 1112.13(f) would require that
CPSC Form 223 and all required accompanying documentation be submitted
electronically via the CPSC Web site. We have established an electronic
application system accessed via our Internet site at: http://www.cpsc.gov/about/cpsia/labaccred.html. Proposed Sec. 1112.13(g)
would reserve the authority to require additional information from an
applicant laboratory to determine whether the laboratory meets the
relevant criteria. This provision would allow us to gather additional
information if the initial information supplied by an applicant
laboratory was insufficient. This paragraph also would state that we
may, before acting on an application, verify the accreditation
certificate and statement of scope directly from the accreditation
body.
Finally, proposed Sec. 1112.13(h) would provide that a laboratory
may retract an application at any time before the CPSC has acted on it.
We would note, however, that a retraction would not end or nullify any
enforcement action that the CPSC is authorized to pursue.
3. Proposed Sec. 1112.15--When can a third party assessment body apply
for CPSC acceptance for a particular CPSC rule and/or test method?
Proposed Sec. 1112.15(a) would state, consistent with section
14(a)(3) of the CPSA, that a laboratory may apply to the CPSC for
acceptance of its accreditation to test a children's product to a
particular CPSC rule and/or test method once the Commission has
published the requirements for accreditation of third party conformity
assessment bodies to assess conformity with that rule and/or test
method. A laboratory would be able to apply for acceptance to more than
one CPSC rule and/or test method at a time. Alternatively, a laboratory
also would be able to apply separately for various CPSC rules and/or
test methods. A laboratory would only be authorized to issue test
results for purposes of section 14 of the CPSA for tests that fall
within the CPSC rules and/or test methods for which its accreditation
has been accepted by the CPSC.
Proposed Sec. 1112.15(b) would list the rules and test methods for
which the Commission has published the requirements for accreditation
of laboratories. The list is current through August 10, 2011. When any
final rule resulting from this proposed rule publishes, we intend to
add to this list those CPSC rules and/or test methods for which we have
published proposed requirements between October 1, 2011 and the date of
the final rule. After any final rule publishes, additions or revisions
to this list would be proposed as amendments to this section.
Some notices of requirements contained unique provisions related to
exactly what a laboratory's statement of scope must indicate for the
CPSC to accept that accreditation. Those unique provisions are included
in this list.
In the Federal Register of September 20, 2011, we published a
proposed rule to establish a safety standard for play yards. See 76 FR
58167, (September 20, 2011). The standard would be codified at 16 CFR
part 1221. We are working on a final rule to establish a safety
standard for play yards and hope to issue it in the near future.
Consequently, proposed Sec. 1112.15(b)(7) would include 16 CFR part
1221 among the list of CPSC rules and/or test methods for accreditation
for third party conformity assessment bodies. If, however, the
Commission does not issue a final rule to establish a safety standard
for play yards, we will revise Sec. 1112.15(b) accordingly, as part of
this rulemaking process.
In the Federal Register of February 10, 2012, we published a
proposed rule to establish a safety standard for infant swings. See 77
FR 7011, (February 10, 2012). The standard would be codified at 16 CFR
part 1223. We are working on a final rule to establish a safety
standard for infant swings and hope to issue it in the near future.
Consequently, proposed Sec. 1112.15(b)(8) would include 16 CFR part
1223 among the list of CPSC rules and/or test methods for accreditation
for third party conformity assessment bodies. If, however, the
Commission does not issue a final rule to establish a safety standard
for infant swings, we will revise Sec. 1112.15(b) accordingly, as part
of this rulemaking process.
We have included the notice of requirements for the safety standard
for portable bedrails at proposed Sec. 1112.15(b)(9) in the list
because we have published a final rule establishing the safety standard
for bed rails (16 CFR part 1224) in the Federal Register. See 77 FR
12182 (February 29, 2012).
We will accept retrospective testing for 16 CFR part 1224 under
certain circumstances. For the tests contained in 16 CFR part 1224,
testing before the effective date of 16 CFR part 1112 will be accepted,
if the following conditions are met:
The children's product was tested by a third party
conformity assessment body accredited to ISO/IEC 17025:2005 by a
signatory to the ILAC-MRA at the time of the test. The scope of the
third party conformity body accreditation must include testing in
accordance with

[[Page 31114]]

16 CFR part 1224. For firewalled third party conformity assessment
bodies, the firewalled third party conformity assessment body must be
one that the Commission, by order, has accredited on or before the time
that the children's product was tested, even if the order did not
include the tests contained in 16 CFR part 1224. For governmental third
party conformity assessment bodies, the governmental third party
conformity assessment body must be one whose accreditation was accepted
by the Commission, even if the scope of accreditation did not include
the tests contained in 16 CFR part 1224.
The third party conformity assessment body's application
for acceptance of its accreditation is accepted by the CPSC on or after
May 24, 2012 and before the effective date of 16 CFR part 1112.
The test results show compliance with 16 CFR part 1224.
The children's product was tested on or after the date of
publication in the Federal Register of the final rule for 16 CFR part
1224, and before the effective date of 16 CFR part 1112.
The testing laboratory's accreditation remains in effect
through the effective date of 16 CFR part 1112.
Additionally, the notice of requirements pertaining to 16 CFR part
1303, Ban of Lead-Containing Paint and Certain Consumer Products
Bearing Lead-Containing Paint, is listed at proposed Sec.
1112.15(b)(10). According to our initial notice of requirements for
part 1303 (73 FR 54564 (Sept. 22, 2008)), in order for us to accept a
laboratory to test children's products for conformity with the lead-
paint ban, the laboratory's scope of accreditation had to include 16
CFR part 1303 (73 FR 54565). Part 1303 does not contain a test method.
We received comments from the public, asking us to specify test methods
to ensure that accreditation bodies are able to determine the
acceptable technologies and methods for lead analyses. On April 5,
2011, we published a revision to the notice of requirements for part
1303 to specify particular test methods, one or more of which
laboratories must have in their scope of accreditation in order for us
to accept their accreditation to test for conformity with the lead
paint ban.
Proposed Sec. 1112.15(b)(10) would list the approved test methods
for 16 CFR part 1303, ``Ban of Lead-Containing Paint and Certain
Consumer Products Bearing Lead-Containing Paint'' and require a third
party conformity assessment body to reference one or more of the
approved test methods in its statement of scope:
CPSC Standard Operating Procedure for Determining Lead
(Pb) in Paint and Other Similar Surface Coatings, CPSC-CH-E1003-09 and/
or CPSC-CH-E1003-09.1;
ASTM F 2853-10, ``Standard Test Method for Determination
of Lead in Paint Layers and Similar Coatings or in Substrates and
Homogenous Materials by Energy Dispersive X-Ray Fluorescence
Spectrometry Using Multiple Monochromatic Excitation Beams.''
The original notice of requirements pertaining to 16 CFR part 1303
did not require reference to any particular test method. See 73 FR
54564 (Sept. 22, 2008). In order to give third party conformity
assessment bodies sufficient time to amend their scope of accreditation
to include one or more of the test methods listed in proposed Sec.
1112.15 (b)(10):
Third party conformity assessment bodies that were listed
on the CPSC's Web site as accepted to 16 CFR part 1303 on April 5, 2011
(the date when the CPSC published the revision to the notice of
requirements in the Federal Register, see 76 FR 18646) have until April
5, 2013, to reapply and be accepted by the Commission with an statement
of scope that includes one or more of the test methods listed in
proposed Sec. 1112.15(b)(10);
Third party conformity assessment bodies that were not
listed on the CPSC Web site as accepted to 16 CFR part 1303 on April 5,
2011, and apply for acceptance to 16 CFR part 1303 on or before April
5, 2012, have the option to apply without reference to one or more of
the test methods listed in proposed Sec. 1112.15(b)(10);
Third party conformity assessment bodies that were not
listed on the CPSC Web site as accepted to 16 CFR part 1303 on April 5,
2011, and apply for acceptance after April 5, 2012, must have one or
more of the test methods listed in proposed Sec. 1112.15(b)(10) on
their statement of scope.
Proposed Sec. 1112.15(b)(11) would reference 16 CFR part 1420,
Safety Standard for All-Terrain Vehicles. We note that recently, we
published a final rule in the Federal Register, revising 16 CFR part
1420. See 77 FR 12197 (February 29, 2012). The final rule makes
American National Standard, ANSI/SVIA-1-2010, the new mandatory
standard for ATVs, and the new standard is effective April 30, 2012,
replacing the previous standard, which was designated ANSI/SVIA-1-2007.
For purposes of testing youth ATVs, however, ANSI/SVIA 1-2010 is
functionally equivalent to ANSI/SVIA 1-2007 because the changes
specified in the 2010 edition do not substantially change the
requirements applicable to, nor do they affect the associated
conformance testing of youth ATVs. Consequently, the Commission is
continuing its acceptance of accreditation of the third party
conformity assessment body to test youth ATVs. (As of February 7, 2012,
we had accepted the accreditation of a single third party conformity
assessment body to test youth ATVs.) Thus, the third party conformity
assessment body should test youth ATVs for compliance with ANSI/SVIA 1-
2010, as incorporated by reference in 16 CFR part 1420. Based on such
testing, manufacturers of youth ATVs should issue certificates under
section 14(a)(2) of the CPSA.
Third party conformity assessment bodies that are accredited to
test youth ATVs to the 2007 version of the ATV standard for children's
product certification purposes do not need to become reaccredited to
the 2010 revision before the next time their accreditation body
reassesses them to the ATV standard. However, they may elect to do so.
Third party conformity assessment bodies, whose accreditation to test
to the 2007 version of the ATV standard has previously been accepted by
the CPSC, must be accredited to the 2010 revision of the ATV standard
when reassessed by their accreditation body, and submit a Form 223 with
the applicable accompanying documents to the CPSC in order to continue
to have their accreditation to the ATV standard accepted. We will
revise our listing of the third party conformity assessment body when
it becomes accredited to the ATV standard and the CPSC accepts their
application for accreditation.
For third party conformity assessment bodies that applied for CPSC
acceptance of accreditation to the 2007 version of the ATV standard
before we accepted the 2010 revision of the ATV standard as a mandatory
standard, and the CPSC accepts that accreditation, test results from
the third party conformity assessment body can be used for children's
product certification purposes until the third party conformity
assessment body is reassessed by its accreditation body to the ATV
standard. If the third party conformity assessment body wishes to have
its accreditation continue to be accepted by the CPSC after it is
reassessed by its accreditation body, it must become accredited to the
2010 revision of the standard and submit a new Form 223 with
accompanying documents to the CPSC, requesting acceptance of its
accreditation to the 2010 revision of the standard.

[[Page 31115]]

New third party conformity assessment body applicants that apply
for CPSC acceptance on or after May 24, 2012 must be accredited to the
2010 revision when applying for CPSC acceptance of their accreditation
to test youth ATVs.
We also note four revisions to our lead-content test methods.
Proposed Sec. 1112.15(b)(28) and (29), Lead Content in Children's
Metal Jewelry and Limits on Total Lead in Children's Products:
Children's Metal Products, would contain two proposed revisions. First,
the notices of requirements related to testing for lead content in
children's metal jewelry (73 FR 78331 (Dec. 22, 2008)) and total lead
in children's products (74 FR 55821 (Oct. 29, 2009)) each listed the
test method numbered CPSC-CH-E1001-08 as the required test method for
testing for lead in children's metal products (including metal
jewelry). We revised that test method in June 2010. The revised method
allows for some alternative, simplified procedures for certain portions
of the test method. Second, we propose allowing the use of XRF
spectrometry to determine the lead content in certain metals. The
option of using the revised test methods would be reflected in proposed
Sec. 1112.15(b)(28) and (29). Accordingly, the proposed rule would
provide 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 either Test Method CPSC-CH-E1001-08
(the original test method) and/or Test Method CPSC-CH-E1001-08.1 (the
revised test method allowing alternative, simplified procedures) and/or
the proposed revision of the test method, Test Method CPSC-CH-E1001-
08.2 (allowing the use of XRF for certain metals) in its scope of
accreditation.
Third, proposed Sec. 1112.15(b)(30), Limits on Total Lead in
Children's Products: Non-Metal Children's Products, also would contain
a proposed revision relative to the original notice of requirements.
The notice of requirements related to testing for total lead in
children's products (74 FR 55821 (Oct. 29, 2009)) listed the test
method numbered CPSC-CH-E1002-08 as the required test method for
testing for lead in non-metal children's products. We revised that test
method in June 2010; the revised method allows for some alternative,
simplified procedures for certain portions of the test method. Fourth,
we propose allowing the use of XRF to determine the lead content in
glass materials and crystals. This option would be reflected in
proposed Sec. 1112.15(b)(30). Accordingly, the proposed rule would
state that, to be considered for CPSC acceptance of accreditation to
test for lead in non-metal children's products, an applicant laboratory
may have Test Method CPSC-CH-E1002-08 (the original test method) and/or
Test Method CPSC-CH-E1002-08.1 (the revised test method allowing
alternative, simplified procedures) and/or Test Method CPSC-CH-E1002-
08.2 (allowing the use of XRF for glass materials and crystals) in its
scope of accreditation.
We have identified a potential opportunity to reduce the testing
burdens for certification of conformity related to the new requirements
in ASTM F 963-11. Among the changes in ASTM F 963-11, are changes in
the requirements and test methods for eight elements of interest:
antimony, arsenic, barium, cadmium, chromium, lead, mercury, and
selenium. ASTM F 963-11 extends the requirements from prior versions
(which had limits for these elements in surface coatings) to consider,
in addition, these elements in substrates. For substrates and surface
coatings, ASTM F 963-11 limits soluble migration of each of these
elements when tested in dilute acid. Additionally, a new optional
screening test is established in section 8.3.1 ASTM F 963-11, which is
based on the total concentration of those elements, determined by
digesting the samples completely, in hot, concentrated, strong acids,
using methods based on CPSC test methods for lead content.
ASTM F 963-11 allows the screening test from section 8.3.1 to be
performed on a toy to establish that the total concentration of each of
the eight elements of interest is lower than each of the soluble limits
for those elements. For example, a toy that has only 10 ppm of each of
those elements could not possibly leach more than the soluble limits
for any of the elements (which are all greater than 10 ppm); and thus,
the solubility test could be skipped. In another example, a toy that
contained 2,000 ppm barium would not pass the screening test for barium
and would require solubility testing according to section 8.3 to
determine how much barium would leach out (compared to the limit of
1,000 ppm soluble barium).
We recognize that firms potentially could reduce testing costs if a
single test would meet the screening test of section 8.3.1 of ASTM F
963-11 and the CPSIA lead content requirements for paint, metals, or
nonmetals. The methods provided in section 8.3.1 of ASTM F 961-11 refer
to CPSC test methods, but with a prescribed modification. The CPSC test
methods for lead in paint (http://www.cpsc.gov/about/cpsia/CPSC-CH-E1003-09_1.pdf), lead in nonmetals (http://www.cpsc.gov/about/cpsia/CPSC-CH-E1002-08_1.pdf), and lead in metals (http://www.cpsc.gov/about/cpsia/CPSC-CH-E1001-08_1.pdf) each allow for modifications based
on sound chemical judgment and knowledge. CPSC staff tested a variety
of well-characterized paint, metal, and nonmetal materials, and based
upon the results and our professional judgment and experience, we found
that the modifications detailed in section 8.3.1.2 of ASTM F 963-11
represent sound chemical judgment to improve the recovery of antimony
in certain samples. In addition, we believe that they are acceptable
for use for lead in paint, lead in metals, and lead in nonmetals and
are considered to be within the existing scope of allowable changes to
the CPSC methods. Because these modifications are considered
acceptable, a CPSC-accepted testing laboratory accredited to the CPSC
method for lead in paint, CPSC-CH-E1003-09, for example, could test the
paint from a toy, according to CPSC-CH-E1003-09, with the modifications
provided in section 8.3.1.2 of ASTM F 963-11, and still fulfill the
requirements of CPSC-CH-E1003-09 to certify lead content and use the
same testing to determine the screening levels for the other elements
of interest. Because samples that fail the screening may pass section
4.3.5 solubility limits, a testing laboratory must be accredited in
ASTM F 963-11, Section 8.3 to have its test results used to demonstrate
compliance with the limits given in section 4.3.5. In the example
above, the testing for lead in paint, with the modifications, could be
used to determine if the elements of interest pass the screening test
and the toy can be certified to section 4.3.5, without additional
testing; paints exceeding screening limits for any of the elements of
interest would have to be tested according to section 8.3 for heavy
element solubility.
Proposed Sec. 1112.15(b)(31) would reference the limits on
phthalates in children's toys and child care articles. The notice of
requirements pertaining to phthalates approved of two test methods, at
least one of which must be included in a laboratory's accreditation
scope document in order for us to accept the laboratory to test for the
limits on phthalates, and both test methods are included in proposed
Sec. 1112.15(b)(31).
The notice of requirements pertaining to toys also contained unique
provisions related to exactly what a laboratory's statement of scope
must indicate for the CPSC to accept that accreditation.

[[Page 31116]]

Pursuant to section 106 of the CPSIA, the provisions of ASTM
International's (formerly the American Society for Testing and
Materials) (``ASTM'') Standard Consumer Safety Specification for Toy
Safety, F 963, are considered to be consumer product safety standards
issued by the Commission. For reasons explained in the notice of
requirements, see 76 FR 46598, 46599 through 46600 (Aug. 3, 2011), only
certain provisions of ASTM F 963 are subject to third party testing
requirements. We will accept the accreditation of laboratories only to
those sections of ASTM F 963 that are subject to third party testing
requirements. The list of sections of ASTM F 963 for which laboratories
may apply for CPSC acceptance, which must each be specifically
referenced in the laboratories' scope documents, was contained in the
notice of requirements and is reproduced in proposed Sec.
1112.15(b)(32).
Additionally, proposed Sec. 1112.15(b)(32) would reflect recent
revisions to the ASTM F 963 standard. On February 15, 2012, the
Commission, pursuant to section 106(g) of the CPSIA, accepted the
revised toy standard (ASTM F 963-11) as a consumer product safety
standard. 77 FR 10358, (February 22, 2012). ASTM F 963-11 is, in many
ways, equivalent or functionally equivalent to ASTM F 963-08. For
example, in the notice of requirements that we issued on August 3,
2011, some 23 sections in ASTM F 963-08 remain unchanged in ASTM F 963-
11, and another seven sections in ASTM F 963-11 are functionally
equivalent to their earlier counterparts in ASTM F 963-08. (By
``functionally equivalent,'' we mean that the standards organization
made certain changes in the revised standard compared to the earlier
standard, but the changes are not substantial and do not affect the
associated conformance testing.) Consequently, the Commission is
continuing its acceptance of accreditation of third party conformity
assessment bodies for those provisions in ASTM F 963-11 that are
equivalent or functionally equivalent to their corresponding provisions
in ASTM F 963-08. The third party conformity assessment bodies should
test toys for compliance with ASTM F 963-11, and based on such testing,
manufacturers should issue certificates under section 14(a)(2) of the
CPSA.
Third party conformity assessment bodies that are accredited to
test to provisions of ASTM F 963-08 that are equivalent or functionally
equivalent for children's product certification purposes do not need to
become reaccredited to the ASTM F 963-11 revision before the next time
their accreditation body reassesses them to ASTM F 963 toy standard.
However, they may elect to do so. Third party conformity assessment
bodies whose accreditation to test to ASTM F 963-08 has previously been
accepted by the CPSC must be accredited to the ASTM F 963-11 revision
when reassessed by their accreditation body, and they must submit a
Form 223 with the applicable accompanying documents to the CPSC in
order to continue to have their accreditation to ASTM F 963-11
accepted. We will revise our listing of the third party conformity
assessment body when it becomes accredited to the ASTM F 963-11
standard and the CPSC accepts their application for accreditation.
For third party conformity assessment bodies that applied for CPSC
acceptance of accreditation to ASTM F 963-08 before the Commission
accepted ASTM F 963-11 as a mandatory standard, and before we accepted
that accreditation, test results from the third party conformity
assessment body for those provisions of ASTM F 963-08 that are
equivalent or functionally equivalent to ASTM F 963-11, can be used for
children's product certification purposes until the third party
conformity assessment body is reassessed by its accreditation body to
the ASTM F 963 toy standard. If the third party conformity assessment
body wishes to have its accreditation continue to be accepted by the
CPSC after it is reassessed by its accreditation body, it must become
accredited to the ASTM F 963-11 and submit a new Form 223 with
accompanying documents to the CPSC, requesting acceptance of its
accreditation to the 2011 revision of the standard.
New third party conformity assessment body applicants that apply
for CPSC acceptance on or after May 24, 2012 must be accredited to the
ASTM F 963-11 revision when applying for CPSC acceptance of their
accreditation to test toys under ASTM F 963.
ASTM F 963-11, however, did make substantial changes to certain
provisions in ASTM F 963-08 or added new testing or requirements. These
changes are seen in the following sections of ASTM F 963-11:
Section 4.3.5.1(2), Surface Coating Materials--Soluble
Test for Metals;
Section 4.3.5.2, Toy Substrate Materials;
Section 4.15, Stability and Overload Requirements;
Section 4.37, Yo-Yo Elastic Tether Toys; and
Section 4.39, Jaw Entrapment in Handles and Steering
Wheels.

Therefore, proposed Sec. 1112.15(b)(32) would add section 4.3.5.1(2)
from ASTM F 963-11, ``Surface Coating Materials--Soluble Test for
Metals,'' and section 4.3.5.2, ``Toy Substrate Materials,'' to the list
of provisions in ASTM F 963 that require third party testing. The
proposed rule, like the earlier notice of requirements for ASTM F 963-
08, would continue to list section 4.15, ``Stability and Overload
Requirements,'' section 4.37, ``Yo-Yo Elastic Tether Toys,'' and
section 4.39, ``Jaw Entrapment in Handles and Steering Wheels''; but
third party conformity assessment bodies should understand that these
sections in ASTM F 963-11 are not equivalent to ASTM F 963-08.
Furthermore, if we had accepted the third party conformity assessment
body's accreditation to sections 4.15, 4.37, or 4.39 of ASTM F 963-08,
the third party conformity assessment body should become accredited to,
and apply for, CPSC acceptance for its accreditation under sections
4.15, 4.37, and 4.39 of ASTM F 963-11.
Proposed Sec. 1112.15(b)(32) would establish and codify those
provisions of ASTM F 963-11 that would require accreditation and third
party testing. However, we are aware that another revision to ASTM F
963 may occur (see http://news.consumerreports.org/baby/2012/01/revised-toy-safety-standards-are-in-the-works.html. If after the
proposed rule is published in the Federal Register, the Commission
receives a revision to ASTM F 963-11 from ASTM and subsequently accepts
the revision, we will (assuming that we issue a final rule) revise
Sec. 1112.15(b)(32) in the final rule to reflect the most current
version of ASTM F 963 approved by the Commission in lieu of ASTM F 963-
11.
We will accept testing on children's products conducted by a third
party conformity assessment body accepted by the Commission for those
sections of ASTM F 963-08 that are considered equivalent or
functionally equivalent to ASTM F 963-11, as discussed above. For those
tests in ASTM F 963-11 that have no equivalent or functionally
equivalent test in ASTM F 963-08, testing before the effective date of
ASTM F 963-11 will be accepted, if the following conditions are met:
The children's product was tested by a third party
conformity assessment body accredited to ISO/IEC 17025:2005 by a
signatory to the ILAC-MRA at the time of the test. The scope of the
third party conformity assessment body accreditation must include the
tests contained in the applicable nonequivalent section of ASTM F 963-

[[Page 31117]]

11. For firewalled third party conformity assessment bodies, the
firewalled third party conformity assessment body must be one that the
Commission, by order, has accredited, on or before the time that the
children's product was tested, even if the order did not include the
nonequivalent tests contained in ASTM F 963-11. For governmental third
party conformity assessment bodies, the governmental third party
conformity assessment body must be one whose accreditation was accepted
by the Commission, even if the scope of accreditation did not include
the tests for the nonequivalent tests contained in ASTM F 963-11.
The third party conformity assessment body's application
for acceptance of its accreditation is accepted by the CPSC on or after
May 24, 2012 and before the effective date for 16 CFR part 1112.
The test results show compliance with the nonequivalent
section(s) of ASTM F 963-11.
The children's product was tested on or after February 22,
2012, and before the effective date of 16 CFR part 1112.
The third party conformity assessment body's accreditation
remains in effect through the effective date of 16 CFR part 1112.
4. Proposed Sec. 1112.17--How will the CPSC respond to each
application?
Proposed Sec. 1112.17 would establish the procedures related to
CPSC action on a third party conformity assessment body's application
for CPSC acceptance of its accreditation.
Proposed Sec. 1112.17(a) would state that CPSC staff will review
each application, and they may contact applicant laboratories with
questions or to request submission of missing information.
Proposed Sec. 1112.17(b), consistent with section 14(f)(2)(D) of
the CPSA, would state that an application from a firewalled laboratory
will be accepted by order of the Commission, if the Commission makes
certain findings that are required by the statute; the required
findings are enumerated. We intend that CPSC staff will act on
applications from independent and governmental laboratories, as long as
such action is consistent with a proper delegation of authority from
the Commission.
Proposed Sec. 1112.17(c) would state that the CPSC will
communicate its decision on each application, in writing, to the
applicant; the written decision may be by electronic mail.
5. Proposed Sec. 1112.19--How does the CPSC publish information
identifying third party conformity assessment bodies that have been
accepted?
In accordance with section 14(a)(3)(E) of the CPSA, proposed Sec.
1112.19 would provide that the CPSC will maintain on its Web site an
up-to-date listing of third party conformity assessment bodies whose
accreditations have been accepted, and the scope of each acceptance. We
would update the listing regularly to account for changes of
information and status, such as the addition of CPSC rules and/or test
methods to a scope of accreditation; changes to accreditation
certificates; or a new address. In addition, we propose to update the
listing to indicate changes in status, such as if a laboratory
voluntarily discontinues its participation with the CPSC, or if the
CPSC suspends or withdraws our acceptance of the accreditation of a
laboratory (which we discuss later in this document).
6. Proposed Sec. 1112.21--May a third party conformity assessment body
use testing methods other than those specified in the relevant CPSC
rule and/or test method?
Proposed Sec. 1112.21 would require a CPSC-accepted laboratory to
use only a test method specified by the CPSC for a particular CPSC rule
and/or test method, for any test conducted for purposes of section 14
of the CPSA. The proposed rule would require laboratories to use a
CPSC-specified test method(s) for several reasons. First, a specified
test method firmly establishes how to generate test results that are
acceptable to the CPSC as indicative of compliance, so there may be a
common understanding between laboratories and the CPSC. Second, by
specifying the test method, greater consistency among tests conducted
at different laboratories is established. Variations between laboratory
tests are reduced. Finally, it serves as a common procedure that
accreditation bodies can use to evaluate a laboratory for a particular
CPSC rule and/or test method. By evaluating to a CPSC-specified test
method, the accreditation bodies can determine whether the laboratory
meets competency requirements to carry out that particular test.
7. Proposed Sec. 1112.23--May a CSPC-accepted third party conformity
assessment body subcontract work conducted for purposes of section 14
of the CPSA?
The purpose of having each third party conformity assessment body
satisfy CPSC requirements in order for its accreditation to be eligible
for acceptance is to promote competent and consistent test results
across laboratories. Proposed Sec. 1112.23(a) would prohibit
subcontracting of tests conducted for purposes of section 14 of the
CPSA, unless the subcontract is to a CPSC-accepted laboratory. In
addition, the CPSC's acceptance of the scope of accreditation of the
subcontracting laboratory must include the test being subcontracted.
For example, in order for Laboratory A to subcontract the test for
lead-containing paint to Laboratory B, Laboratory B would need to have
had its accreditation to 16 CFR part 1303 (lead-containing paint)
accepted by the CPSC. In this example, we would refer to Laboratory A
as the prime contractor, and Laboratory B would be the subcontractor.
Any violation of this provision would constitute compromising the
integrity of the testing process and could be grounds for withdrawal of
the CPSC's acceptance of the accreditation of the prime- and/or sub-
contracting laboratory under proposed Sec. 1112.47. Given this
restriction and staff's concerns about compromising the integrity of
the testing process, we request comment as to whether subcontracting
ought to be allowed and, if so, under what circumstances. For example,
for what reasons should subcontracting of the preparation of samples
for flammability testing, such as laundering or dry cleaning, be
allowed? We are also interested in comments regarding subcontracting
under other CPSC regulations and the relationship between
subcontracting and the technical competence and protection against
undue influence of the third party testing program as a whole. Under
what conditions could we allow the CPSC-accepted laboratory to vouch
for the independence and technical competence of its subcontractors and
their testing processes without requiring accreditation of the
subcontractor by a signatory to the ILAC-MRA? How would subcontracting
affect the recordkeeping requirements of this rule?
Proposed Sec. 1112.23(b) would state that the provisions of part
1112 apply to all CPSC-accepted laboratories, even if they are a prime
contractor and/or a subcontractor.
8. Proposed Sec. 1112.25--what are a third party conformity assessment
body's recordkeeping responsibilities?
Proposed Sec. 1112.25 would require third party conformity
assessment bodies to retain certain records related to the tests
conducted for purposes of

[[Page 31118]]

section 14 of the CPSA. We are aware that ISO/IEC 17025:2005 contains
some recordkeeping provisions of its own. For example, section 4.13 of
ISO/IEC 17025:2005 addresses ``control of records'' and requires a
laboratory to retain technical records ``for a defined period.''
However, proposed Sec. 1112.25 would impose additional recordkeeping
responsibilities beyond those established in ISO/IEC 17025:2005.
Additional requirements are necessary because we have an interest in
being able to investigate a noncompliant product and/or whether grounds
exist for adverse action against a third party conformity assessment
body. For example, if a product that fails to comply with a children's
product safety rule is present in the market, and the product was
tested by a CPSC-accepted laboratory, we would have an interest in
reviewing the test records related to that product. Additionally, ISO/
IEC 17025:2005 does not specify a record-retention period, which means
different laboratories could retain their records for different periods
of time. If we pursue an investigation, the records we would require in
proposed Sec. 1112.25 are those that would help us conduct that
investigation. Some records, such as a report furnished to a customer
where the report differs from the test record, may not be retained by
some laboratories under ISO/IEC 17025:2005. Therefore, we would impose
these recordkeeping requirements in addition to those imposed via ISO/
IEC 17025:2005.
Proposed Sec. 1112.25(a) would state that all required records
must be legible. In terms of particular records, we would first require
that all test reports and technical records related to tests conducted
for purposes of section 14 of the CPSA be maintained for a period of at
least five years from the date the test was conducted. We propose a 5-
year retention period because the statute of limitations on civil
penalties under the CPSA is five years. See 28 U.S.C. 2462. Next, the
proposed rule would require that, in the case of a test report for a
test conducted by a CPSC-accepted laboratory acting as a sub-
contractor, the prime contractor's test report must clearly identify
which test(s) was performed by a CPSC-accepted laboratory acting as a
subcontractor(s), and the test report from the CPSC-accepted laboratory
acting as a subcontractor must be appended to the prime contractor's
test report.
Proposed Sec. 1112.25(a) would require that, where a report for
purposes of section 14 of the CPSA provided by the laboratory to a
customer is different from the test record, the laboratory also must
retain the report provided to the customer for a period of at least
five years from the date the test was conducted. Finally, the proposed
rule also would require any and all laboratory internal documents
describing testing protocols and procedures (such as instructions,
standards, manuals, guides, and reference data) that have applied to a
test conducted for purposes of section 14 of the CPSA be retained for a
period of at least five years from the date such test was conducted.
Proposed Sec. 1112.25(b) would state that, upon request by the
CPSC, the laboratory must make any and all of the records required by
this section available for inspection, either in hard copy or
electronic form, within 48 hours. We would require that, if the records
are not in English, copies of the original records be made available to
the CPSC within 48 hours, and an English translation of the records be
made available by the laboratory within 30 calendar days of the date we
requested an English translation.
9. Proposed Sec. 1112.27--Must a third party conformity assessment
body allow CPSC inspections related to investigations?
Proposed Sec. 1112.27 would require that each CPSC-accepted third
party conformity assessment body allow an officer or employee duly
designated by the Commission to enter its facility and conduct an
inspection as a condition of the continued CPSC-acceptance of its
accreditation. Such inspections would not be routine and/or for the
purpose of confirming that the laboratory satisfies accreditation
requirements. We intend that audits (addressed in subpart C of part
1112) be the vehicle by which we confirm that a laboratory continues to
satisfy the requirements necessary for our acceptance of its
accreditation. Rather, such inspections would be limited to inspections
related to a CPSC investigation into whether a ground exists for
adverse action against a third party conformity assessment body. An
ability to enter and inspect a laboratory would help us investigate
circumstances, such as an allegation of undue influence or the presence
in the market of a product that fails to comply with a children's
product safety rule, yet is accompanied by a certificate based on a
passing third party test result. In those cases, our investigation may
need to include the laboratory so that we could attempt to obtain facts
relevant to the case at hand.
We would conduct such inspections in accordance with 16 CFR 1118.2,
Conduct and Scope of Inspections. Failure to cooperate with such an
inspection would constitute failure to cooperate with an investigation
and would be grounds for suspension under proposed Sec. 1112.45.
10. Proposed Sec. 1112.29--How does a third party conformity
assessment body voluntarily discontinue its participation with the
CPSC?
Proposed Sec. 1112.29(a) would provide that a third party
conformity assessment body may voluntarily discontinue participation as
a CPSC-accepted laboratory at any time and for any portion of its scope
that is accepted by the CPSC. It also would provide the procedural
requirements for such voluntary discontinuance.
To voluntarily discontinue its participation as a CPSC-accepted
laboratory, the laboratory would have to notify us in writing. This
notification may be sent electronically. The notice would have to
include the name, address, phone number, and electronic mail address of
the laboratory and the person responsible for submitting the request.
The notice also would need to include the scope of the discontinuance;
the beginning date for the discontinuance; a statement that the
laboratory understands that it must reapply for acceptance of the
accreditation scope for which it is requesting discontinuance; and
verification that the person requesting the discontinuance has the
authority to make such a request on behalf of the laboratory.
Proposed Sec. 1112.29(b) would state that we may verify the
information submitted in a notice of voluntary discontinuance.
Proposed Sec. 1112.29(c) would explain that, 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, we will update our Web site to indicate that we no longer
accept the accreditation of the third party conformity assessment body
as of the date provided and for the scope indicated in the notice.
Proposed Sec. 1112.29(d) would note that we may begin or continue
an investigation related to an adverse action under this part, or any
other legal action, despite the voluntary discontinuation of a
laboratory.

C. Subpart C--Audit Requirements for Third Party Conformity Assessment
Bodies

1. Proposed Sec. 1112.35(b)--When must an audit be conducted?
As explained in the audit final rule published elsewhere in this
issue of the

[[Page 31119]]

Federal Register, for purposes of part 1112, an audit consists of two
parts. The first part, known as ``reassessment,'' is an examination by
an accreditation body to determine whether the third party conformity
assessment body meets or continues to meet the conditions for
accreditation. The second part, which we refer to as ``examination,''
is the resubmission of the ``Consumer Product Conformity Assessment
Body Acceptance Registration Form'' (CPSC Form 223) and accompanying
documentation by the laboratory, and the CPSC's examination of the
resubmitted materials.
The reassessment portion of an audit is conducted, at a minimum, at
the frequency established by its accreditation body. Proposed Sec.
1112.35(b) would establish when the examination portion of an audit
must be conducted.
Proposed Sec. 1112.35(b)(1) would have each laboratory submit a
new CPSC Form 223 and applicable accompanying documentation, no less
than every two years. The proposed rule would begin the implementation
of this provision by assigning an audit date to each CPSC-accepted
laboratory. The initial audit date, which will be assigned based on
such factors as when the laboratory was last accepted by the CPSC, and
the expiration date of the laboratory's ISO/IEC 17025:2005 certificate,
will be no sooner than three months, and no later than two years, after
any final rule resulting from this proposed rule is published.
Laboratories that were not previously CPSC-accepted laboratories and
that apply to the CPSC after the publication of a final rule resulting
from this proposed rule will be issued an audit date based upon the
date of CPSC acceptance of accreditation as posted on the CPSC Web
site.
Proposed Sec. 1112.35(b)(2) would note that proposed Sec.
1112.13(a)(1) would require a third party conformity assessment body to
submit a new CPSC Form 223 whenever the information supplied on the
form changes. If the third party conformity assessment body submits a
new CPSC Form 223 to provide updated information, the third party
conformity assessment body may elect to have the new CPSC Form 223
satisfy the audit requirement of proposed Sec. 1112.35(b)(1). If the
laboratory also intends to satisfy the audit requirement of proposed
Sec. 1112.35(b)(1), it would need to indicate that intent clearly when
it submits a CPSC Form 223. In addition, the laboratory would need to
upload all applicable accompanying documentation.
Proposed Sec. 1112.35(b)(3) would state that, at least 30 days
before the date by which a third party conformity assessment body must
submit a CPSC Form 223 for audit purposes, we will notify the body, in
writing, of the impending audit deadline. The notice may be delivered
by electronic mail. A laboratory may request an extension of the
deadline for the examination portion of the audit, but it must indicate
how much additional time is requested, and it also must explain why
such an extension is warranted. The CPSC will notify the laboratory
whether its request for an extension has been granted.

D. Subpart D--Adverse Actions: Types, Grounds, Allegations, Procedural
Requirements, and Publication

Proposed subpart D would implement section 14(e) of the CPSA. It
would establish whether, when, and how we may deny a third party
conformity assessment body's application and suspend and/or withdraw a
previously-granted acceptance of a laboratory's accreditation. It also
would establish how a person may submit to the CPSC information
alleging a ground for adverse action, including an allegation of undue
influence. This subpart also would address the publication of adverse
actions.
1. Proposed Sec. 1112.41--What are the possible adverse actions the
CPSC may take against a third party conformity assessment body?
Proposed Sec. 1112.41 would list the potential adverse actions we
may take against a third party conformity assessment body. Proposed
Sec. 1112.41(a) lists the possible actions: denial of acceptance of
accreditation; suspension of acceptance of accreditation; or withdrawal
of acceptance of accreditation. These actions will each be discussed
further below, in relation to the proposed sections that address each
possible action.
Proposed Sec. 1112.41(b) would state that withdrawal of acceptance
of accreditation can be on a temporary or permanent basis, and the CPSC
may immediately withdraw its acceptance in accordance with Sec.
1112.53 of this part.
2. Proposed Sec. 1112.43--What are the grounds for denial of an
application?
Proposed Sec. 1112.43(a) would list the bases for denying an
application for acceptance of accreditation from a third party
conformity assessment body. There would be three reasons for denying an
application.
First, proposed Sec. 1112.43(a)(1) would state that we may deny a
laboratory's application if the laboratory failed to submit a complete
application. We would state that all information and/or attestations
required by CPSC Form 223 are necessary components of an application.
We also would state that all accompanying documentation required in
connection with an application is a necessary component of an
application. We would provide notice of a deficiency and would deny an
application if the laboratory failed to correct the deficiency within
30 days.
Proposed Sec. 1112.43(a)(2) would provide the second basis upon
which we would be able to deny an application. The proposed rule would
address the submission of false or misleading information concerning a
material fact(s) on either an application, any materials accompanying
an application, or on any other information provided to the CPSC
related to a laboratory's ability to become or to remain a CPSC-
accepted laboratory. A fact would be considered material if its
inclusion in the application, any materials accompanying an
application, or on any other information provided to the CPSC, would
have resulted in the application's denial.
Third, proposed Sec. 1112.43(a)(3) would state that we may deny an
application if the applicant laboratory failed to satisfy the necessary
requirements described in Sec. 1112.13, such as ISO/IEC 17025:2005
accreditation by an ILAC-MRA signatory accreditation body for the scope
for which acceptance of accreditation is being sought.
Proposed Sec. 1112.43(b) would state that the CPSC's denial of an
application will follow the process described in Sec. 1112.51 of this
part.
3. Proposed Sec. 1112.45--What are the grounds for suspension of CPSC
acceptance?
Section 14(e)(3) of the CPSA states that the Commission may suspend
the accreditation of a conformity assessment body if it fails to
cooperate with the Commission in an investigation under section 14 of
the CPSA. Proposed Sec. 1112.45 would implement that statutory
provision.
The procedures relevant to adverse actions would be addressed in
proposed Sec. 1112.51, which we will describe and discuss more fully
below. For current purposes, however, we note that proposed Sec.
1112.51(a) would provide that the CPSC may investigate when it is aware
that grounds for an adverse action may exist. For example, if we
receive an allegation of undue influence concerning a CPSC-accepted
laboratory, we may (depending on the strength of the allegation) launch
an investigation. As another example, if a product was

[[Page 31120]]

present in the market that failed to comply with a children's product
safety rule, yet is supported by a certificate based on a CPSC-accepted
laboratory's passing test result, we may investigate whether the
laboratory is, in fact, conducting tests according to a CPSC-required
test method. Under proposed Sec. 1112.51(a)(4), we would provide
written notice to a laboratory upon commencement of an investigation.
Section 1112.45(a) would state that we may suspend our acceptance
of a laboratory's accreditation for any portion of its CPSC scope when
the laboratory fails to cooperate with an investigation under section
14 of the CPSA. The proposed rule would state further that a third
party conformity assessment body ``fails to cooperate'' when it does
not respond to CPSC inquiries or requests, or responds in a manner that
is unresponsive, evasive, deceptive, or substantially incomplete, or
when the laboratory fails to cooperate with an investigatory inspection
under proposed Sec. 1112.27.
If we determine that a laboratory is not cooperating with an
investigation, under proposed Sec. 1112.51(b), we would provide an
initial notice of adverse action to the laboratory. This initial notice
would state that the CPSC proposes to suspend the laboratory, and it
would specify the actions the laboratory would need to take to avoid
suspension. Proposed Sec. 1112.45(b) would state that suspension will
last until the laboratory complies, to our satisfaction, with required
actions, as outlined in the initial notice described in proposed Sec.
1112.51(b), or until we withdraw our acceptance of the laboratory.
Proposed Sec. 1112.45(c) would provide that we will lift the
suspension of CPSC acceptance if we determine that the third party
conformity assessment body is cooperating sufficiently with the
investigation. The suspension would lift as of the date of our written
notification to the laboratory, which may be by electronic mail,
indicating that we are lifting the suspension.
4. Proposed Sec. 1112.47--What are the grounds for withdrawal of CPSC
acceptance?
Proposed Sec. 1112.47 would establish the grounds upon which we
may withdraw acceptance of the accreditation of a third party
conformity assessment body for any portion of its CPSC scope.
The first ground for withdrawal would be that a manufacturer,
private labeler, governmental entity, or other interested party has
exerted undue influence on such conformity assessment body, or
otherwise interfered with, or compromised, the integrity of the testing
process. Proposed Sec. 1112.3 would define ``undue influence'' to mean
that a manufacturer, private labeler, governmental entity, or other
interested party affects a third party conformity assessment body, such
that commercial, financial, or other pressures compromise the integrity
of its testing processes or results. Undue influence can take many
forms. For example, it would be undue influence if a laboratory
director instructs laboratory personnel to alter a test report to
indicate a passing result, rather than a failing result, because a
customer has exerted pressure on the laboratory director by threatening
to withdraw its business if the laboratory report indicates a failing
result. Another example of undue influence would be if a manager of a
firewalled laboratory asks a laboratory technician not to report a
failing test result because it would delay a large shipment of
products. Similarly, in the case of a firewalled laboratory, a
manufacturing manager who urges the laboratory to complete the testing
promptly and ``cut corners'' on the normal testing procedures so that
the factory can ship product to meet a production quota for the month,
would be attempting to apply undue influence. In the governmental
laboratory context, undue influence might take the form of a government
official influencing a laboratory to report falsely that a sample
passed a test in order to facilitate exports.
The second ground for withdrawal, at proposed Sec. 1112.47(b),
would be that the third party conformity assessment body failed to
comply with an applicable protocol, standard, or requirement under
proposed subpart C of this part. This provision implements section
14(e)(1)(B) of the CPSA.
The third ground for withdrawal, at proposed Sec. 1112.47(c),
would state that we may withdraw our acceptance of the accreditation of
a laboratory if the laboratory fails to comply with any provision in
subpart B of this part. As a reminder, proposed subpart B would
establish the general requirements pertaining to third party conformity
assessment bodies, such as requirements, processes, and timing related
to applying for CPSC acceptance, recordkeeping requirements, and
limitations on subcontracting. Thus, examples of failure to comply with
subpart B would include a laboratory that loses its ISO/IEC 17025:2005
accreditation (either for the entire laboratory or for any portion of
its CPSC scope) or has such accreditation suspended; a firewalled
laboratory that fails to continue to satisfy the relevant statutory
criteria; or a laboratory that fails to use, in relation to a test
conducted for purposes of section 14 of the CPSA, a CPSC-specified test
method.
5. Proposed Sec. 1112.49--How may a person submit information alleging
grounds for adverse action, and what information should be submitted?
Proposed Sec. 1112.49(a) would allow any person to submit
information alleging that one or more of the grounds for adverse action
exists. The information may be submitted in writing or electronically.
Any request for confidentiality would need to be indicated clearly in
the submission.
Proposed Sec. 1112.49(a) also would list the information to be
included in a submission alleging grounds for adverse action. First,
the submission should include the name and contact information of the
person making the allegation. Second, the submission should identify
the laboratory against whom the allegation is being made, as well as
any officials or employees of the laboratory relevant to the
allegation, in addition to contact information for those individuals.
Third, a person alleging a ground for adverse action should identify
any manufacturers, distributors, importers, private labelers, or
governmental entities relevant to the allegation, along with any
officials or employees of the manufacturers, distributors, importers,
private labelers, and/or governmental entities relevant to the
allegation, as well as contact information for those individuals.
Fourth, a submission should include a description of acts and/or
omissions to support each asserted ground for adverse action.
Generally, the submission should describe, in detail, the basis for the
allegation that grounds for adverse action against a laboratory exists.
In addition to a description of the acts and omissions and their
significance, a description may include: dates, times, persons,
companies, governmental entities, locations, products, tests, test
results, equipment, supplies, frequency of occurrence, and negative
outcomes. When possible, the submission should attach documents,
records, photographs, correspondence, notes, electronic mails, or any
other information that supports the basis for the allegations. Finally,
a submission of grounds for adverse action should include a description
of the impact of the acts and/or omissions, where known.
Proposed Sec. 1112.49(b) would state that, upon receiving the
information, we

[[Page 31121]]

would review the information to determine if it is sufficient to
warrant an investigation. We may deem the information insufficient to
warrant an investigation if the information fails to address adequately
the categories of information outlined in paragraph (a) of this
section.
6. Proposed Sec. 1112.51--What are the procedures relevant to adverse
actions?
Proposed Sec. 1112.51 would describe the process by which we may
deny an application from a laboratory, suspend our acceptance of the
accreditation of a laboratory, withdraw our acceptance of the
accreditation of a laboratory on a temporary or permanent basis; and/or
immediately temporarily withdraw our acceptance of the accreditation of
a laboratory.
Proposed Sec. 1112.51(a)(1) would state that investigations, for
purposes of part 1112, are investigations into grounds for an adverse
action against a third party conformity assessment body. Proposed Sec.
1112.51(a)(2) would explain that we would use our Procedures for
Investigations, Inspections, and Inquiries, 16 CFR part 1118, subpart
A, to investigate under this part.
Proposed Sec. 1112.51(a)(3) would provide that an investigation
under this part may include: any act we may take to verify the
accuracy, veracity, and/or completeness of information received in
connection with an application for acceptance of accreditation; a
submission alleging grounds for an adverse action; or any other
information we receive, which relates to a laboratory's ability to
become or remain a CPSC-accepted laboratory.
Proposed Sec. 1112.51(a)(4) would state that we would begin an
investigation by providing written notice, which may be electronic, to
the laboratory. The notice would inform the laboratory that we have
received information sufficient to warrant an investigation, and it
would describe the information received by the CPSC, as well as
describe our investigative process. The notice also would inform the
laboratory that failure to cooperate with a CPSC investigation is
grounds for suspension.
Proposed Sec. 1112.51(a)(5) would state that any notice sent by
the CPSC under proposed 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 we have finalized elsewhere in this
issue of the Federal Register) constitutes an investigation for
purposes of this section.
Failure to cooperate in an investigation under this part is grounds
for the CPSC to suspend its acceptance of the accreditation of a
laboratory under proposed Sec. 1112.45. In addition, we note that
section 19(a)(13) of the CPSA makes it unlawful for any person to make
a material misrepresentation to an officer or employee of the
Commission in the course of an investigation.
Proposed Sec. 1112.51(b) would state that if, after investigation,
we determine that grounds for adverse action exist, and we propose to
take an adverse action against a laboratory, we would notify the
laboratory, in writing, which may be electronic, about the proposed
adverse action. If the proposed adverse action is suspension or
withdrawal, the CPSC's notice formally would begin a proceeding to
suspend or withdraw our acceptance of its accreditation, as described
in section 14(e) of the CPSA. The notice would contain the CPSC's
proposed adverse action; specify grounds on which the proposed adverse
action is based; and provide findings of fact to support the proposed
adverse action. This notice also would contain, when appropriate,
specific actions a third party conformity assessment body must take to
avoid an adverse action. For example, if a laboratory submitted an
incomplete application, we would notify the laboratory of the
deficiencies that the laboratory would need to remedy to avoid denial
of the application. Also, when the proposed adverse action is
withdrawal, the notice would contain consideration of the criteria set
forth in proposed Sec. 1112.51(d)(1).
The notice in proposed Sec. 1112.51(b) also would contain the time
period by which a laboratory has to respond to the notice. In general,
the notice would inform the laboratory that it has 30 calendar days to
respond. A laboratory may request an extension of the response time,
but it must explain why such an extension is warranted and indicate the
amount of additional time needed for a response. Finally, the notice
would state that, except under proposed Sec. 1112.53 (which we discuss
below in section IV.D.7 of this preamble), a CPSC-accepted laboratory
would be able to continue to conduct tests for purposes of section 14
of the CPSA until a Final Notice of adverse action is issued.
Proposed Sec. 1112.51(c) would address how the laboratory may
respond to the initial notice. The proposed rule would require the
laboratory's response to be in writing, which may be by electronic
mail, and in English.
Responses contemplated under proposed Sec. 1112.51(c) could
include, but would not be limited to, an explanation or refutation of
material facts upon which the CPSC's proposed action is based,
supported by documents or a sworn affidavit; results of any internal
review of the matter, and action(s) taken as a result; or a detailed
plan and schedule for an internal review. Proposed Sec. 1112.51(c)
would explain that the response is the laboratory's opportunity to
state its case that the ground(s) for adverse action does not exist, or
explain why the CPSC should not pursue the proposed adverse action, or
any portion of the proposed adverse action. If a laboratory responds to
the notice in a timely manner, we would review the response, and, if
necessary, conduct further investigation to explore or resolve issues
bearing on whether grounds exist for adverse action, and the nature and
scope of the proposed adverse action. If a laboratory does not submit a
response to the notice in a timely manner, we would be able to proceed
to a Final Notice, as described in proposed Sec. 1112.51(e), without
further delay.
Proposed Sec. 1112.51(d) would address the adverse action
proceeding. Proposed Sec. 1112.51(d)(1) would reiterate the factors
that we must consider in any proceeding to withdraw under section
14(e)(2)(A) of the CPSA. The proposed rule would state that we will
consider the gravity of the laboratory's action or failure to act,
including: Whether the action or failure to act resulted in injury,
death, or the risk of injury or death; whether the action or failure to
act constitutes an isolated incident or represents a pattern or
practice; and whether and when the third party conformity assessment
body initiated remedial action.
Proposed Sec. 1112.51(d)(2) would state that, in all cases, we
would review and take under advisement, the response provided by the
third party conformity assessment body. Except for cases under proposed
Sec. 1112.51(d)(3), we would determine what action is appropriate
under the circumstances. Proposed Sec. 1112.51(d)(3) would clarify
that any suspension or withdrawal of a firewalled laboratory would
occur by order of the Commission. We consider this provision to be
consistent with section 14(f)(2)(D) of the CPSA and its requirement
that the accreditation of a firewalled laboratory may be accepted by
Commission order only.
Proposed Sec. 1112.51(d)(4) would reiterate section 14(e)(2)(B)(i)
of the CPSA, and would state that the CPSC may withdraw its acceptance
of the accreditation of a laboratory on a

[[Page 31122]]

permanent or temporary basis. Proposed Sec. 1112.51(d)(5) would
reiterate section 14(e)(2)(B)(ii) of the CPSA and would state that, if
we withdraw our acceptance of the accreditation of a laboratory, we may
establish requirements for the reacceptance of the laboratory's
accreditation. Any such requirements would be related to the reason(s)
for the withdrawal.
Proposed Sec. 1112.51(e) would detail the Final Notice. If, after
reviewing a laboratory's response to a notice, and conducting
additional investigation, where necessary, we determine that grounds
for adverse action exist, we would send a Final Notice to the
laboratory, in writing, which may be electronic. The Final Notice would
state the adverse action that we are taking, the specific grounds on
which the adverse action is based, and the findings of fact that
support the adverse action. When the adverse action is withdrawal, the
Final Notice would address the consideration of the criteria as set
forth in proposed Sec. 1112.51(d)(1) and would state whether the
withdrawal is temporary or permanent, and, if the withdrawal is
temporary, the duration of the withdrawal. The Final Notice would
inform the laboratory that its accreditation is no longer accepted by
the CPSC as of the date of the Final Notice of denial, suspension, or
withdrawal for any specified portion(s) of its CPSC scope. The Final
Notice also would inform the laboratory that the CPSC Web site will be
updated to reflect adverse actions taken against a previously CPSC-
accepted laboratory. Finally, the Final Notice would inform the
laboratory whether it may submit a new application.
Proposed Sec. 1112.51(f) would state that, upon receipt of a Final
Notice, a third party conformity assessment body, as applicable, may
submit a new application (if the Final Notice indicated such) or file
an Administrative Appeal.
Proposed Sec. 1112.51(g) would address Administrative Appeals.
Except for cases covered in proposed Sec. 1112.51(g)(2), a laboratory
could file an Administrative Appeal with the Office of the Executive
Director. The Administrative Appeal would need to be sent by mail
within 30 calendar days of the date on the Final Notice; proposed Sec.
1112.51(g) would provide the appropriate mailing and electronic mail
addresses. The proposed rule would require all appeals to be in
English; to explain the nature and scope of the issues appealed from in
the Final Notice; and describe, in detail, the reasons why the
laboratory believes that no grounds for adverse action exist.
The Executive Director would issue a Final Decision within 60
calendar days of receipt of an Administrative Appeal. If the Executive
Director's Final Decision would require more than 60 calendar days, he
or she would notify the third party conformity assessment body that
more time is required, state the reason(s) why more time is required,
and, if feasible, include an estimated date for a Final Decision to
issue.
Proposed Sec. 1112.51(g)(2) would address the circumstance in
which the Commission has suspended or withdrawn its acceptance of the
accreditation of a firewalled laboratory. Because suspensions and
withdrawals of firewalled laboratories must occur by order of the
Commission, Administrative Appeals, in these cases, would be filed with
the Commission. The Administrative Appeal would need to be sent to the
Office of the Secretary by mail within 30 calendar days of the date on
the Final Notice. The proposed rule would require all appeals to be in
English, to explain the nature of the issues appealed in the Final
Notice, and to describe in detail the reasons why the laboratory
believes that no ground(s) exist for adverse action.
7. Proposed Sec. 1112.53--Can the CPSC immediately withdraw its
acceptance of the accreditation of a third party conformity assessment
body?
Under proposed Sec. 1112.51(b)(7) a CPSC-accepted third party
conformity assessment body generally would be able to continue to
conduct tests for purposes of section 14 of the CPSA during an
investigation and the procedures leading up to an adverse action, until
a Final Notice of adverse action is issued. Proposed Sec. 1112.53
would establish a means of immediately and temporarily withdrawing the
accreditation of a laboratory in the rare circumstance that it would be
in the public interest to remove our acceptance of the laboratory while
we pursue an investigation and potential adverse action against the
laboratory under proposed Sec. 1112.51.
Section 12 of the CPSA addresses imminent hazards. Proposed Sec.
1112.53 would use section 12 of the CPSA as a guide. We do not foresee
many circumstances under which we would be so concerned with the
testing conducted by a CPSC-accepted laboratory that we would need to
stop the laboratory from conducting third party tests of children's
products while we investigate and proceed against the laboratory.
However, because any such circumstances would endanger the public, the
proposed rule would enable us to do exactly that in certain prescribed
conditions and after following particular procedures.
Proposed Sec. 1112.53(a) would state that, when it is in the
public interest to protect health and safety, and notwithstanding any
other provision of this part, we would be able to immediately and
temporarily withdraw our acceptance of a laboratory's accreditation for
any portion of its CPSC scope while we pursue an investigation and
potential adverse action. Proposed Sec. 1112.53(a)(1) would define
``in the public interest to protect health and safety'' to mean that
the CPSC has credible evidence that: (1) The integrity of test(s) being
conducted under a scope for which we have accepted the laboratory's
accreditation have been affected by undue influence or otherwise
interfered with or compromised; and (2) any portion of a CPSC scope for
which we have accepted the laboratory's accreditation involve a
product(s) which, if noncompliant with CPSC rules, bans, standards,
and/or regulations, constitutes an imminently hazardous consumer
product under section 12 of the CPSA.
Proposed Sec. 1112.53(a)(2) would state that, when presented with
an allegation that, if credible, would result in immediate and
temporary withdrawal of CPSC acceptance of a third party conformity
assessment body's accreditation, the investigation and adverse action
procedures described in Sec. 1112.51 apply, except that instead of the
timeframes described in Sec. 1112.51, the following timeframes would
apply when the CPSC pursues immediate and temporary withdrawal: The
Initial Notice will generally inform the third party conformity
assessment body that it has 7 calendar days to respond; an
administrative appeal of a Final Notice of immediate and temporary
withdrawal will be timely if filed within 7 calendar days of the date
of the Final Notice.
Proposed Sec. 1112.53(b) would state that, if the laboratory is
already the subject of an investigation or adverse action process, the
immediate and temporary withdrawal would remain in effect until either
we communicate in writing that the immediate and temporary withdrawal
has been lifted, the investigation concludes and we do not propose an
adverse action, or the adverse action process concludes with denial,
suspension, or withdrawal. Under proposed Sec. 1112.53(c), 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) would be launched based on the same information that
justified the immediate and temporary withdrawal.

[[Page 31123]]

8. Proposed Sec. 1112.55--Will the CPSC publish adverse actions?
Proposed Sec. 1112.55 would state that, immediately following a
final adverse action, we would be able to publish the fact of a final
adverse action, the text of a final adverse action, or a summary of the
substance of a final adverse action. In addition, after issuance of a
final adverse action, we would amend our Web site listing of CPSC-
accepted laboratories to reflect the nature and scope of such adverse
action.

E. Proposed Sec. 1118.2--Conduct and Scope of Inspections

The Commission's regulations on investigations, inspections, and
inquiries under the CPSA are located at 16 CFR part 1118. Subpart A of
part 1118 prescribes CPSC procedures for investigations, inspections,
and inquiries. Section 1118.2 addresses topics such as how the CPSC
conducts an inspection, which sites the CPSC has authority to inspect,
and what the CPSC may view or obtain during an inspection.
The proposed rule would amend Sec. 1118.2(a) in two ways. First,
it would include firewalled third party conformity assessment bodies as
entities that we may inspect. This amendment is necessary to conform
Sec. 1118.2(a) with the statutory language in section 16(a) of the
CPSA and the inspection provision at proposed Sec. 1112.27. Second, it
would remove the word ``consumer'' before the word ``product''
throughout paragraph (a), for accuracy. Some children's products
regulated by the Commission and that are required by the CPSA to be
third party tested are not regulated primarily under the CPSA. For
example, some toys are regulated under the Federal Hazardous Substances
Act, 15 U.S.C. 1261-1278. To be consistent with the inspection
provision at proposed Sec. 1112.27, the references to ``product'' must
be broad enough to include more than just products subject to CPSA
safety standards.
Normally, we would use the plain language ``must'' rather than
``shall'' when describing mandatory requirements in a rule. However,
because we are amending one paragraph of a section that was drafted
using ``shall,'' we will continue to use ``shall'' in this paragraph,
to avoid any potential confusion that might arise from the appearance
of inconsistent terminology within Sec. 1118.2.

V. Regulatory Flexibility Act

A. Introduction

The Regulatory Flexibility Act (RFA), 5 U.S.C. chapter 6, requires
the agency to evaluate the economic impact of this proposed rule on
small entities. The RFA defines ``small entities'' to include small
businesses, small organizations, and small governmental jurisdictions.
Section 603 of the RFA requires the CPSC to prepare an initial
regulatory flexibility analysis and make it available to the public for
comment when the notice of proposed rulemaking is published. The
initial regulatory flexibility analysis must describe the impact of the
proposed rule on small entities and identify any alternatives that may
reduce the impact. Specifically, the initial regulatory flexibility
analysis must contain:

1. [A] description of the reasons why action by the agency is
being considered;
2. [A] succinct statement of the objectives of, and legal basis
for, the proposed rule;
3. [A] description of and, where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
4. [A] description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the
requirements and the type of professional skills necessary for the
preparation of reports or records;
5. [A]n identification, to the extent possible, of all relevant
Federal rules which may duplicate, overlap, or conflict with the
proposed rule.

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

Additionally, the initial regulatory flexibility analysis must
contain a description of any significant alternatives to the proposed
rule that accomplish the stated objectives of the proposed rule while
minimizing the economic impact on small entities.

B. Reasons the Commission is Considering the Proposed Rule

Section 14(a)(2)of the CPSA requires that a manufacturer or private
labeler of a children's product subject to a children's product safety
rule submit samples of the product to a CPSC-accepted third party
conformity assessment body for testing for compliance with the rule.
Based on the testing, the manufacturer or private labeler must issue a
certificate that certifies that the children's product complies with
the applicable children's product safety rule(s). This proposed rule
would codify, inter alia, the requirements and process by which a
laboratory may apply for CPSC acceptance of its accreditation, the
process for a laboratory to voluntarily discontinue providing testing
to support a children's product certification, and the procedures by
which the CPSC may suspend or withdraw its acceptance of the
accreditation of a laboratory.

C. Objectives of and Legal Basis for the Proposed Rule

The primary objective of the proposed rule is to codify the
requirements pertaining to laboratories, including the requirements and
processes related to obtaining CPSC acceptance of their accreditation.
Codifying the requirements related to obtaining CPSC acceptance of
accreditation will make it easier for interested parties to locate the
requirements because, from September 2008 through August 2011, the CPSC
has issued 19 notices of requirements pertaining to specific
regulations or test methods. This rule would compile the requirements
in a single location.
The proposed rule also would establish the grounds for and
procedures by which the CPSC could suspend or withdraw its acceptance
of the accreditation of a laboratory. Additionally, where the required
test method(s) is not specified in a children's product safety rule,
provisions in the proposed rule (Sec. 1112.15, Sec. 1112.17) would
formally establish the test method(s) that laboratories must use to
assess conformity with the particular rule.
The legal bases of the rule are found in section 14 of the CPSA, as
amended by section 102 of the CPSIA, and section 3 of the CPSIA.
Section 3 of the CPSIA grants the CPSC the authority to issue
regulations to implement the CPSIA and the amendments made by the
CPSIA. Section 14(a)(3) of the CPSA provides the authority for the CPSC
to establish the accreditation requirements for laboratories. Section
14(e) of the CPSA provides the authority for the CPSC to suspend and/or
withdraw the acceptance of the accreditation of a laboratory.

D. Description and Estimate of the Number of Small Entities to Which
the Proposed Rule Would Apply

This proposed rule would apply to laboratories that intend to offer
their testing services to manufacturers and private labelers of
children's products for purposes of supporting a certification that the
products conform to applicable children's product safety rules. The
proposed rule would not impose any requirements on laboratories that do
not intend to provide these services.
Although there are 5,041 firms classified as ``testing
laboratories'' (NAICS code 54138) in the United States,\2\ only a small
subset of these

[[Page 31124]]

laboratories are expected to provide third party conformity assessments
of children's products for purposes of section 14(a)(2)of the CPSA. As
of August 29, 2011, the CPSC has accepted the accreditation of 87
laboratories located in the United States.\3\ This number could
increase somewhat over the next year or so as the remaining notices of
requirements for accreditation are issued and the stays of enforcement
of the requirements for third party testing that the Commission issued
pending clarification of the regulations and testing requirements, are
lifted. Of the laboratories located in the United States with CPSC-
accepted accreditations, 12 are owned by large, foreign-based companies
and 22 are large, U.S.-based companies. The remaining 53 laboratories
(about 61 percent) could be small firms, according to the criteria
established by the U.S. Small Business Administration (SBA), which for
a laboratory is revenue of less than $12 million annually.
---------------------------------------------------------------------------

\2\ Based on 2007 data from the U.S. Census Bureau that was
compiled by the U.S. Small Business Administration (available at
http://www.sba.gov/advo/research/us_rec07.txt).
\3\ CPSC has recognized the accreditations of at least 346 (if
using the date of Aug 17, 2011) testing laboratories worldwide.
However, most of the laboratories are located in other countries.
Only domestic firms are relevant for purposes of the RFA.
---------------------------------------------------------------------------

E. Projected Reporting, Recordkeeping, and Other Compliance
Requirements

1. Accreditation Requirements
The proposed rule would establish the requirements for CPSC
acceptance of the accreditation of a laboratory. The rule would apply
only to laboratories that intend to provide third party testing of
children's products in support of the certification required by section
14(a)(2) of the CPSA. The proposed rule would not impose any
requirements on laboratories that do not intend to provide these
services.
The proposed rule would require that, as a condition of CPSC
acceptance of its accreditation, the laboratory must be accredited to
the Standard ISO/IEC 17025:2005, ``General Requirements for the
Competence of Testing and Calibration Laboratories.'' The accreditation
must be by an accreditation body that is a signatory to the
International Laboratory Accreditation Cooperation--Mutual Recognition
Arrangement (ILAC-MRA). The scope of the accreditation must list the
CPSC safety rule(s) and/or test method(s) for which acceptance is
sought. This aspect of the proposed rule would simply codify the
existing conditions for CPSC acceptance of accreditation, which have
been stated in every notice of requirements published by the CPSC.
The proposed rule would require that laboratories provide the CPSC
with their accreditation certificate and scope documents. These records
are normally generated during the accreditation process and can be
provided to the CPSC electronically. The application form for the CPSC
acceptance of accreditation is CPSC Form 223. This is an electronic
application form and all of the information that is required to be
supplied on the form should be readily available to the laboratory. The
professional skills required to complete CPSC Form 223 and the related
documents are skills that a competent, accredited laboratory would be
expected to have.
The proposed rule also would require firewalled laboratories to
submit additional materials. The additional documents would provide
evidence that, despite the fact that the laboratory is managed, owned,
or controlled by a manufacturer or private labeler, the testing process
is independent of that relationship. The acceptance of a firewalled
laboratory's accreditation would occur only by Commission order after
it has made certain findings. The additional documents required to
support the findings include:

The laboratory's policies and procedures that explain:
[cir] How the third party conformity assessment body will
protect its test results from undue influence by the manufacturer,
private labeler, or other interested party;
[cir] 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
[cir] That allegations of undue influence may be reported
confidentially to the CPSC;
Training documents, including a description of the
training program content, showing how employees are trained annually
on the policies and procedures described above.
Training records listing the staff members who received
the required training. The records must include training dates,
location, and the name and title of the individual providing the
training;
An organizational chart(s) of the laboratory that
includes the names of all laboratory personnel, both temporary and
permanent, and their reporting relationship within the laboratory;
An organizational chart(s) of the broader organization
that identifies the reporting relationships of the laboratory within
the broader organization (using both position titles and staff
names); and
A list of all laboratory personnel with reporting
relationships outside of the laboratory. The list must identify the
name and title of the relevant laboratory employee(s) and the names,
titles, and employer(s) of all individuals outside of the laboratory
to whom they report.

The proposed rule also would establish requirements for CPSC
acceptance of the accreditation of laboratories that are owned or
controlled by a government. The additional requirements for this type
of laboratory include a description, which may be in the form of a
diagram, that illustrates relationships with other entities, such as
government agencies and joint venture partners, and answering questions
that will be used by the CPSC to determine whether it meets the
statutory requirements for acceptance of its accreditation. The
laboratory must also provide a copy of an executed memorandum addressed
to all staff members and displayed for staff reference stating the
laboratory policy to reject undue influence over its testing results by
any outside person or entity. The memorandum must add that employees
are required to report immediately to their supervisor or other
designated official about any attempts to gain undue influence and that
the laboratory will not tolerate violations of its undue influence
policy. Further, a senior officer of the laboratory must make
attestations regarding the continuing accuracy of the conditions and
policies of the laboratory.
Laboratories that are owned by foreign governments do not meet the
definition of a ``small entity'' under the Regulatory Flexibility Act.
To date, we have accepted one application from a domestic governmental
laboratory.
There are no fees payable to the CPSC associated with applying for
CPSC acceptance of accreditation. The costs of obtaining ISO/IEC
17025:2005 accreditation by a signatory to the ILAC-MRA typically
include a one-time application fee, an annual fee for each field in
which the laboratory is accredited, and an assessment fee. These
charges will vary somewhat among accreditation bodies; but
representative charges, based on the published fee schedule of one
accreditation body, are $800 for the initial application fee, $1,300
per field for the annual fee, and $135 per hour per assessor. A
representative of an accreditation body stated that assessments can
take from 1 to 5 days, with 2.5 days being about average.
Based on the above discussion, a laboratory seeking accreditation
in one field of testing can expect to pay around $4,800 in fees. The
cost could be higher if the assessment takes more than 2.5 days. If the
laboratory is seeking accreditation in more than one field, such as
chemical and mechanical

[[Page 31125]]

testing, the cost will be higher because there will be additional fees
for each field, and the assessment will likely take more time. In
addition, the laboratory can be expected to be charged for the cost of
the assessor's travel, lodging, and meals while conducting the
assessment. There will be some cost to the laboratory in terms of
personnel to prepare documents for the assessment and to work with the
assessors during the assessment.
If a laboratory is already accredited to ISO/IEC 17025:2005 by an
accreditation body that is a signatory to the ILAC-MRA, and the
laboratory is simply seeking to expand its scope of accreditation to
include specific CPSC tests, the cost to the laboratory will be
substantially less. In some cases, if the laboratory's scope already
includes closely related tests, the accreditation body might be willing
to add the CPSC tests to the scope without additional charges. In other
cases, there could be some administrative or assessment charges, but
these would be less than would be required for a full initial
assessment.
For most product safety rules, the required test methods were
specified in the regulation that established the safety rule. However,
in the case of the requirements limiting the lead content of children's
products, the test methods have been specified in the notices of
requirements for accreditation, because the limits on acceptable lead
were established in law via the CPSIA. The proposed rule would expand
the list of acceptable test methods for measuring lead content to
include the use of XRF for measuring the lead content of glass
materials, crystals, and certain metals. Because XRF can be
significantly less expensive than other approved test methods, such as
inductively coupled plasma or atomic absorption spectrometry, this
provision could lower the laboratories testing costs. Some or all of
the cost reductions could be passed onto the consumer product
manufacturers in the form of lower testing prices.
ISO/IEC 17025:2005 has requirements for the periodic reassessment
of accredited laboratories. We are addressing these requirements in the
separate but related rulemaking on periodic audits.
2. Recordkeeping Requirements
The proposed rule would require that laboratories maintain certain
records associated with the testing conducted for purposes of section
14(a)(2) of the CPSA for at least five years. The retention requirement
would apply to all test reports and technical records, records related
to subcontracted tests, and customer reports, if different from the
test record, if related to tests conducted for purposes of section
14(a)(2) of the CPSA. Additionally, all internal documents describing
testing protocols and procedures (such as instructions, standards,
manuals, guides, and reference data) that have applied to a test
conducted for purposes of section 14(a)(2)of the CPSA must be retained
for a period of at least five years from the date such test was
conducted. Upon a request by the CPSC, the laboratory must make the
records available to the CPSC within 48 hours. If the records are not
in English, the proposed rule would require that the laboratory provide
the CPSC with copies of the non-English record available to the CPSC
within 48 hours, and the laboratory must make an English translation
available within 30 days of a request to do so. All records must be
legible, but they can be in electronic format or hardcopy, so long as
they are readily retrievable.
3. Grounds and Procedures for Adverse Actions Against CPSC-Accepted
Laboratories
The proposed rule also would establish the grounds and procedures
that the CPSC would use to take adverse actions against a laboratory.
Adverse actions would include: Denying the acceptance of the
laboratory's accreditation, suspending the acceptance of the
laboratory's accreditation for a period of time, or withdrawing the
acceptance of the laboratory's accreditation on a temporary or
permanent basis. Grounds for these adverse actions would include: A
failure to comply with CPSC requirements, failure to cooperate with the
CPSC during an investigation, and allowing a manufacturer or other
party to exert undue influence on the testing process. Among other
things, the rule would establish the requirements for the notices that
the CPSC must provide a laboratory before taking an adverse action, the
time limits for responses by the laboratory to the notice, and the
laboratory's appeal rights.
During an investigation of an allegation, some costs would be
incurred by the laboratory for things such as making employees
available for interviews with CPSC investigators, providing the CPSC
with documents or records requested by the investigators, and allowing
CPSC investigators access to its facilities. The cost incurred would
depend upon the scope of the investigation. If the CPSC proposed an
adverse action against the laboratory, the laboratory could incur some
cost in preparing a reply to the notice, if it chooses to reply. The
number of investigations of laboratories that the CPSC will open is not
known.
4. Summary
Laboratories that intend to provide third party testing services
for purposes of section 14(a)(2) of the CPSA will incur some costs to
obtain CPSC acceptance of their accreditation. The costs would be low
for laboratories that are already accredited to ISO/IEC 17025:2005 by a
body that is an ILAC-MRA signatory. If the laboratory is not already
accredited to ISO/IEC 17025:2005 by an ILAC-MRA signatory, it can
expect to incur fees of around $4,800. The fees could be higher if the
laboratory sought accreditation in more than one field of testing or
the assessment took more than 2.5 days. If the CPSC opened an
investigation of the laboratory, the laboratory would likely incur some
costs in connection with the investigation.
As noted, the requirements in this proposed rule would apply only
to those laboratories that intend to provide third party testing
services for purposes of section 14(a)(2) of the CPSA. The only
laboratories that are expected to provide those services are those that
expect to receive sufficient revenue from providing the testing to
justify accepting the requirements as a business decision. Laboratories
that do not expect to receive sufficient revenue from these services to
justify accepting these requirements would not be expected to pursue
accreditation for this purpose. Therefore, one would not expect the
requirements to have a significant adverse impact on a substantial
number of laboratories.

F. Federal Rules That Duplicate, Overlap, or Conflict With the Proposed
Rule

We have not identified any federal rules that duplicate, overlap,
or conflict with the proposed rule.

G. Significant Alternatives Considered

The RFA directs agencies to describe significant alternatives to
the proposed rule that would minimize the significant economic impacts
on small entities, while accomplishing the agency's objectives. We
considered two alternatives to provisions in the proposed rule. One
alternative was for the CPSC to accept the accreditation of
laboratories that had been accredited by bodies other than just those
that are signatories to the ILAC-MRA. The second alternative involved
accepting XRF test methods for determining lead

[[Page 31126]]

content in paint, children's metal jewelry, and children's metal
products.
1. Accepting Accreditations by Bodies That Are Not ILAC-MRA Signatories
Comments were received in response to several notices of
requirements that the CPSC should accept the accreditation of
laboratories that had been accredited by organizations or accreditation
bodies that are not signatories to the ILAC-MRA. Some of the
organizations not affiliated with the ILAC-MRA, that were suggested by
commenters, are the American Industrial Hygiene Association (AIHA), the
National Lead Laboratory Accreditation Program (NLLAP), the National
Environmental Laboratory Accreditation Conference (NELAC), and
accreditation bodies that are members of the National Cooperation for
Laboratory Accreditation (NACLA).
If we accepted the accreditation of laboratories that were
accredited by these other organizations, it would reduce the cost of
obtaining CPSC acceptance for those laboratories that are accredited by
the non- ILAC-MRA bodies. Under the proposed rule, to gain CPSC
acceptance of their accreditation, these laboratories would have to
seek additional accreditation by a body that is a signatory to the
ILAC-MRA. It is not known how many laboratories that are accredited by
nonsignatories to the ILAC-MRA intend to offer conformity assessment
testing services to manufacturers or private labelers of children's
products for purposes of section 14(a)(2) of the CPSA.
We recognize that there are other laboratory accreditation
organizations or accreditation body cooperations, and we realize that
some of these organizations may adhere to similar rules and standards
(but with some distinctions) as those established in the ILAC-MRA
signatory program. However, CPSC designations to such organizations
would not meet all of the objectives we had when we established, as a
baseline accreditation requirement, accreditation by a body that was a
signatory to the ILAC-MRA. Moreover, we sought to designate a program
that operated and was accepted on a broad, multinational level and that
could immediately bring on board a large number of accreditation bodies
and avoid designating accreditation programs or entities that were
recognized only in specific regions, nations, or localities. In the
absence of establishing conditions for accreditation bodies, any person
or entity can claim to be able to accredit laboratories to ISO/IEC
17025:2005, regardless of their qualifications to do so. It should also
be noted that the AIHA, one of the suggested alternative accreditation
bodies, is now a signatory to the ILAC-MRA.
2. Alternative Test Methods for Lead
The CPSC has received a number of requests to allow more extensive
use of XRF analysis in testing related to lead because XRF analysis is
significantly less expensive than the other test methods for lead
content.
Based on its continuing research of testing methodologies, the
Commission has approved the use of certain XRF methods for determining
the lead content of homogenous polymer components and paints, and the
proposed rule would allow, in addition, the use of certain XRF methods
for determining the lead content of glass materials, crystals, and
certain metals. However, for other materials, CPSC staff has not
determined that XRF is as effective, precise, and reliable as the
approved methods. Therefore, the proposed rule does not expand the
approved use of XRF to cover all materials or substances. We continue
to evaluate improvements in technology and methods on an ongoing basis.
3. Other Potential Alternatives
The RFA directs agencies to consider some specific alternatives to
a proposed rule including:

1. The establishment of different compliance or reporting
requirements for small entities or timetables that take into account
the resources available to small entities;
2. Clarification, consolidation, or simplification of compliance
and reporting requirements for small entities;
3. Use of performance rather than design standards; and
4. Exemption for certain or all small entities from coverage of
the rule, in whole or part.

Other than the alternatives specifically discussed above (regarding
accreditation by bodies that are not signatories to the ILAC-MRA and
alternative testing methods for lead content), we did not identify any
significant alternatives that also would meet the agency's objectives
and fulfill its obligations under the CPSA, as amended by the CPSIA.
However, we welcome comments suggesting other alternatives that could
reduce the burden on small entities, while fulfilling the agency's
objectives.

VI. Paperwork Reduction Act

This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520) (PRA). We describe the provisions in this section
of the document with an estimate of the annual reporting burden. Our
estimate includes the time for completing the application to become a
CPSC-accepted laboratory (CPSC Form 223), including uploading the
accompanying documents that would be required under this rule; for
complying with the proposed recordkeeping requirements; for submitting
the information that would be necessary to discontinue voluntarily as a
CPSC-accepted laboratory; and for supplying the accompanying documents
that would be required at audit.
In particular, we invite comments on the following: (1) Whether the
collection of information is necessary for the proper performance of
the CPSC's functions, including whether the information will have
practical utility; (2) the accuracy of the CPSC's estimate of the
burden of the proposed collection of information, including the
validity of the method and assumptions used; (3) ways to enhance the
quality, utility, and clarity of the information to be collected; and
(4) ways to reduce the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Requirements Pertaining to Third Party Conformity Assessment
Bodies
Description: The proposed rule would establish the requirements
pertaining to the laboratories that are authorized to test children's
products in support of the certification required by section 14(a)(2)
of the CPSA, as amended by section 102(a) of the CPSIA. The proposed
rule would establish the general requirements concerning third party
conformity assessment bodies, such as the requirements and procedures
for CPSC acceptance of the accreditation of a laboratory, and it also
would address adverse actions against CPSC-accepted laboratories. In
addition, the proposed rule would amend the audit requirements for
laboratories.
Description of Respondents: Testing laboratories.
We estimate the burden of this collection of information as
follows: There are no capital costs or operating and maintenance costs
associated with this collection of information.
Our estimates are based on the following: A laboratory desiring to
have its accreditation accepted by the CPSC first must submit an
application, CPSC Form 223. CPSC Form 223 is already an OMB-approved
collection of information, control number 3041-0143,

[[Page 31127]]

which expires on July 31, 2013. In that approved collection, we
estimated that it would take respondents (applicant laboratories) one
hour to complete the form, which includes uploading the ``baseline
documentation'' required of all applicants: the accreditation
certificate, and statement of scope.
The proposed rule, if finalized as written, would necessitate
changes to CPSC Form 223. For purposes of this PRA estimate, we assume
the rule will be finalized as written. To estimate the paperwork burden
associated with the application, we are beginning with the 1-hour time
estimate already approved under control number 3041-0143, and adding to
the one hour estimate, the time we estimate it will take or an
applicant laboratory to comply with the application requirements that
would be newly imposed as a result of this rule.
The proposed rule would require applicant laboratories to attest to
a variety of facts concerning their ownership and legal relationships,
to determine whether the laboratory should be considered an applicant
for firewalled or governmental status. Each characteristic contained in
Sec. 1112.11(b) that indicates a firewalled laboratory, would be
reflected in a statement to which an applicant laboratory would need to
attest with a ``yes'' or ``no'' answer. Similarly, each characteristic
indicating a governmental laboratory, as contained in Sec. 1112.11(c),
would be reflected in a statement to which an applicant laboratory
would need to attest with a ``yes'' or ``no'' answer. We surveyed less
than nine CPSC-accepted laboratories, and we asked them how long it
took them to complete the attestation portion of the current CPSC Form
223. The average of the estimates provided was three minutes. This
proposed rule would expand significantly the list of characteristics
indicating ``governmental'' or ``firewalled'' status, as compared to
the current CPSC Form 223. We estimate that the additional attestation
requirements will take applicants five times longer than the current
attestation section on CPSC Form 223. Accordingly, we estimate that it
would take applicants an additional 15 minutes to complete CPSC Form
223. Thus, the total time estimated to comply with proposed Sec.
1112.13(a) is 75 minutes per respondent. Based on our experience with
the laboratory program to date, we estimate that there will be a total
of 450 laboratories whose accreditations are accepted by the CPSC after
an initial period of about four years. To predict the annual burden, we
divided the number of laboratories by the initial period, to arrive at
an estimated 113 laboratories per year with the 75-minute burden.
Proposed Sec. 1112.13(a)(1) would require CPSC-accepted
laboratories to submit a new CPSC Form 223 whenever information
previously submitted on the form changes. Based on our experience
operating the laboratory program, to date, only about 1 percent of
laboratories per year need to update their information, and the
information changes, thus far, have been limited to items such as a
contact name. A laboratory will not need to fill out an entirely new
CPSC Form 223 to submit new information; the laboratory can access its
existing CPSC Form 223 via the laboratory application program on the
CPSC Web site and change only those elements that are in need of
updating. We estimate that it will take a laboratory that needs to
update its information 15 minutes to do so.
The proposed rule, at Sec. 1112.13(b)(2), would require applicant
firewalled laboratories to submit six documents concerning their
relationship to the manufacturer in addition to their policies on undue
influence. First, an applicant firewalled laboratory must submit their
established policies and procedures addressing undue influence; that
the CPSC will be notified immediately if there is an attempt at undue
influence; and that allegations of undue influence may be reported
confidentially to the CPSC. Because applicant laboratories must be
accredited to ISO/IEC 17025:2005, we know that the laboratories already
have certain policies and procedures in place concerning undue
influence. However, those policies and procedures will not address
reporting attempts at undue influence to the CPSC and that such reports
to the CPSC may be confidential. Therefore, we estimate that a
laboratory will need to amend its policies and procedures to include
these CPSC-related topics. Based on our experience with firewalled
laboratory applications, to date, we estimate that it will take
applicants two hours to develop these additional policies. The
experience of CPSC staff working on firewalled laboratory applications
indicates that often applicants choose to submit draft amended policies
and procedures for feedback prior to finalizing the documents. To err
on the side of overestimating, rather than underestimating the burden,
we will assume that all firewalled applicants will submit draft
documents, and we estimate that applicants will spend an additional
hour revising and finalizing those documents after CPSC staff's initial
review. Therefore, we estimate that laboratories will spend 3 hours
creating these policies and procedures.
In terms of the time it will take an applicant to upload the
policies and procedures once they exist, we estimate eight minutes.
This estimate is based partly on the results of a survey of fewer than
nine laboratories that we asked to estimate the amount of time it took
to upload the baseline documents (accreditation certificate and
statement of scope). On average, it took an applicant four minutes to
locate and upload the two documents. Again, based on our experience
with firewalled laboratory applicants, to date, we estimate that the
required policies and procedures will be reflected in two documents
(e.g., a quality manual and a procedures guide), each of which will
take the estimated four minutes to locate and upload into the CPSC
laboratory application system. To account for submitting a draft
version first, to be followed by a final version, we doubled the 4
minute estimate.
The second submission that the proposed rule would require of
firewalled applicants is training documents showing how employees are
trained annually on the policies and procedures just described (see
Sec. 1112.11(b)(2)(i)). Again, laboratories will already have training
documents, but those documents will need to be amended to reflect CPSC-
related policies (e.g., laboratory staff may report allegations of
undue influence confidentially to the CPSC). Following the same
reasoning that we applied to laboratories that amend their policies and
procedures, we estimate that it will take an applicant firewalled
laboratory three hours to create the necessary training documents.
Following the same reasoning that we applied to the time it would take
to upload the policies and procedures, we estimate that it will take a
firewalled laboratory applicant eight minutes to locate and upload the
necessary training documents.
The third submission the proposed rule would require firewalled
laboratory applicants to furnish training records showing that
laboratory staff were trained on the policies and procedures described
above (see Sec. 1112.11(b)(2)(i)). While we understand that
laboratories maintain training records in the normal course of doing
business, we acknowledge that it is unlikely that all laboratories
routinely maintain records that include all of the elements that would
be required under this rule. For example, while some laboratories may
have employees sign in at each training, other laboratories may not. As
another example, while some laboratories may record who conducted the
training,

[[Page 31128]]

others may not. To account thoroughly for the burden that would be
imposed by this rule, we estimate that it will take each laboratory one
hour to create the training records that would be required under this
rule; this one hour is intended to account for any detail of the
training that a laboratory would record for compliance with this rule
that the laboratory otherwise would not record.
In terms of the time it takes to locate and upload the training
records, we assume that some laboratories will maintain the requisite
information in more than two documents. Based on the survey results
described previously, which indicated that it took an average of four
minutes for respondents to locate and upload two documents, we estimate
that the burden associated with locating and uploading the training
documents requirement is four minutes.
The fourth submission required of firewalled laboratory applicants
is an organizational chart of the laboratory. We assume that a
laboratory will already have such a document, so the time it would take
to comply with this requirement merely would be the time it would take
to locate and upload the chart. Based on the earlier estimate of four
minutes for two documents and because this is only one document, we
estimate the burden associated with this requirement to be two minutes.
Similarly, the fifth submission required of firewalled laboratory
applicants is an organizational chart of the broader organization,
indicating how the laboratory fits into the manufacturing company
structure. Again, we assume that the laboratory will already have
access to such a document that exists in the normal course of the
manufacturer's and laboratory's business. Therefore, the only burden
associated with this proposed requirement would be the time it takes
for the laboratory to locate and upload the chart. Based on the same
reasoning applied for the last organizational chart, we estimate the
burden associated with submitting the broader organization's chart to
be two minutes.
The sixth submission that would be required of firewalled
laboratory applicants is a list of laboratory staff that have reporting
relationships outside the laboratory. We assume, for PRA purposes, that
this document has not been created in the normal course of the
laboratory's business. We do not anticipate that there will be many
laboratory employees with outside reporting relationships. Thus, we
estimate that this will be a short list. Based on similar lists we have
seen from prior firewalled laboratory applicants, we estimate that it
will take a laboratory one hour to create this list. Using the same
reasoning as applied already, we estimate that it will take a
laboratory two minutes to locate and upload this document.
Therefore, based on the above analysis, we estimate that it will
take a firewalled laboratory applicant about 8.4 hours to comply with
the proposed requirements in Sec. 1112.13(b)(2) (188 min. for policies
and procedures + 188 min. for training documents + 64 min. for training
records + 2 min. for laboratory organizational chart + 2 min. for
broader organizational chart + 62 min. for the list of staff with
outside reporting relationship = 506 min.; 506 min./60 min. in each
hour = 8.4 hours).
Proposed Sec. 1112.13(c)(2) addresses the four additional
application requirements for governmental laboratories. The first
requirement would be that a governmental laboratory applicant must
submit a description, which may be in the form of a diagram, which
illustrates the laboratory's relationships with other entities, such as
government agencies and joint ventures. Based on the response from a
governmental laboratory whose accreditation is accepted by the CPSC,
the time required for this is estimated at one hour.
Second, a governmental laboratory applicant would be required to
respond to a questionnaire concerning the criteria for governmental
laboratories; the criteria are statutory in origin, but they appear at
Sec. 1112.13(c)(1) of the proposed rule. Based on our experience with
governmental laboratory applications, to date, we estimate that it
takes each applicant one hour to respond to this questionnaire.
Third, proposed Sec. 1112.13(c)(2)(iii) would require a
governmental laboratory applicant to submit a copy of an executed
memorandum addressing undue influence. Our experience with governmental
laboratory applicants suggests that it will take 0.5 hours to complete
the memorandum. Therefore, we tentatively assign an estimate of 0.5
hours to complete this task.
Fourth, a senior officer of the governmental laboratory applicant
would be required to attest to facts and policies concerning the
applicant. Our experience with governmental laboratory applicants
suggests that it will take 0.5 hours to complete the attestation.
Therefore, we tentatively assign an estimate of 0.5 hours to complete
this task.
Therefore, the total time we estimate that it will take for a
governmental laboratory applicant to comply with the proposed
requirements in Sec. 1112.13(c)(2), is 3 hours (1 hour for the
laboratory relationships description + 1 hour for responding to the
questionnaire + 0.5 hours to complete the memorandum addressing undue
influence + 0.5 hours for the attestation of facts and policies = 3
hours).
Proposed Sec. 1112.25(a) addresses recordkeeping requirements. We
would require that laboratories maintain all test reports and technical
records related to tests conducted for purposes of section 14 of the
CPSA for at least five years. It is our understanding that laboratories
maintain these records in the normal course of their business. However,
we would also require that when a test conducted for purposes of
section 14 of the CPSA is subcontracted, the prime contractor's report
must clearly identify which test(s) was performed by a CPSC-accepted
laboratory acting as a subcontractor, and the test from the
subcontractor must be appended to the prime contractor's report. We
assume, for PRA purposes, that those requirements may not be satisfied
in the normal course of a laboratory's business. Based upon responses
received from laboratories we surveyed, we estimate that on average, a
laboratory conducts 10,188 tests for purposes of section 14 of the CPSA
annually. Based on our experience with the laboratory program, to date,
we estimate that 5 percent of laboratories will subcontract tests to
other CPSC-accepted laboratories. It is difficult to estimate exactly
how many tests will be subcontracted, but for current purposes, we will
estimate that of the laboratories that subcontract, they will
subcontract 25 percent of their tests. To comply with the proposed
recordkeeping requirements related to subcontracted tests, we estimate
that a laboratory will spend five minutes locating and amending a test
report to indicate clearly that one of the test(s) supporting the test
report has been subcontracted. We estimate that it will take 2 minutes
for the laboratory to append the subcontracted report to the main
report (either electronically append, or append hard copies of the
reports [e.g., staple]). Therefore, we estimate that it will take a
laboratory seven minutes to comply with this proposed recordkeeping
requirement. Given the number of laboratories that have already been
accepted by the CPSC, and based on our experience with the rate of new
successful applications, we predict that the total number of
laboratories will be 450. Five percent of 450 laboratories is 23
laboratories. Twenty-five percent of 10,188 tests is 2,547 tests. If 23
laboratories subcontract 2,547 tests per

[[Page 31129]]

year, that is a total of 58,581 subcontracted tests per year. Seven
minutes times 58,581 subcontracted tests produces an estimate of
410,067 minutes, or approximately 6,834 hours per year, to comply with
the recordkeeping requirement proposed at Sec. 1112.25(a)(2).
Proposed Sec. 1112.25(a)(3) would require that if a laboratory,
after conducting a test, chooses to send a report to the customer
different from the laboratory test report, the laboratory must maintain
the report sent to the customer for five years. Any report that falls
within this requirement would be a report that the laboratory has
created in the normal course of its business, and thus, is not part of
the burden associated with this proposed rule.
We also would require laboratories to maintain any and all internal
documents describing testing protocols and procedures, such as
instructions and manuals, for a period of five years. Again, these
documents would exist as part of the laboratory's normal business
activity so that it would not be part of the burden imposed by this
proposed rule.
Proposed Sec. 1112.29(a) would explain that a CPSC-accepted
laboratory may voluntarily discontinue its participation with the CPSC
at any time, by submitting a written notice to the CPSC, and the
proposed rule would detail the information that must be included in the
notice. In the three years that we have been operating the laboratory
program, six laboratories have voluntarily discontinued their
participation with us. To err on the side of overestimating, rather
than inaccurately underestimating the burden, we will assume that six
laboratories will voluntarily discontinue their participation each
year. We propose to require five elements for the voluntary
discontinuance notice, including the name of, and contact information
for, the laboratory, scope of the discontinuance, and the beginning
date of the discontinuance. Based on our experience with the laboratory
program, to date, we estimate that it would take a laboratory one hour
to prepare and send this notice of discontinuance. Because we estimate
that six laboratories per year will submit such a notice, the total
annual burden associated with Sec. 1112.29(a) is estimated to be six
hours per year.
The last section of this proposed rule that imposes paperwork
burdens is a section related to audits. The final audit rule appears
elsewhere in this issue of the Federal Register. Here, we are proposing
to amend the definition of ``audit,'' to include in the definition the
requirement that all laboratories submit at audit, whatever
accompanying documentation would be required if they were submitting an
initial application. Because the CPSC portion of the audit is required
no less than once every two years, we estimate that 50 percent of
laboratories will go through an audit each year. Based on the number of
independent laboratories that have already been accepted by the CPSC
and our experience with the rate of new successful applications, we
predict that the total number of independent laboratories will be 365.
Half of those, or 183 laboratories, will be audited annually. As noted
above, based on results from a survey of fewer than nine laboratories,
it takes applicants an average of four minutes to locate and upload
their accreditation certificate and statement of scope. Therefore, we
estimate that independent labs will spend approximately 12.2 hours
complying with this proposed amendment annually (183 laboratories x 4
minutes = 732 min. annually; 732 min./60 minutes per hour = 12.2
hours).
With regard to the burden associated with proposed Sec.
1112.13(b)(2), we estimated that it would take a firewalled laboratory
applicant 8.4 hours to submit the accompanying documentation required
with their initial application for CPSC acceptance. Seven hours of that
time was allotted for laboratories to create documents specifically
required for testing children's products for purposes of section 14 of
the CPSA. The laboratories will not need to create those documents
again at audit, however. Therefore, instead of the three hours we
estimated that firewalled laboratories would spend developing the
policies and procedures that would be required under Sec.
1112.13(b)(2)(i), we estimate, for audit purposes, that laboratories
will spend one hour reviewing and updating those policies and
procedures. Similarly, instead of the three hours we projected that
laboratories would need for developing the training documents under
Sec. 1112.13(b)(2)(ii), we estimate that laboratories will spend one
hour reviewing and updating those documents at audit. Instead of the
one hour we estimated laboratories would spend creating the list of
employees with outside relationships that would be required under Sec.
1112.13(b)(2)(vi), we estimate laboratories will spend 20 minutes
reviewing and updating that list at audit. Accordingly, instead of the
506 minutes we estimated that a firewalled laboratory would spend in
support of submitting the accompanying documentation at the time of
their initial application for CPSC acceptance, we estimate that a
laboratory will spend 226 minutes in support of submitting the
accompanying documentation at audit (506 min. - 120 min. for policies
and procedures - 120 min. for training documents - 40 min. for list of
employees and outside interests = 226 min.). Based on the number of
firewalled laboratories that have already been accepted by the CPSC and
our experience with the rate of new successful applications, we predict
that the total number of firewalled laboratories will be 35. Half of
those, or 18, will be audited annually. If half of the firewalled
laboratories spend 226 minutes to comply with this aspect of audit
annually, that is an annual paperwork burden of 4,068 minutes, or 68
hours (18 laboratories x 226 minutes = 4,068 minutes annually; 4,068
minutes/60 minutes per hour = approximately 68 hours).
With regard to the burden associated with proposed Sec.
1112.13(c)(2), we estimated that it would take a governmental
laboratory applicant three hours to submit the accompanying
documentation required when they initially apply for CPSC acceptance.
We estimated that one hour would be required to develop a description,
which may be in the form of a diagram, which illustrates the
laboratory's relationships with other entities, such as government
agencies and joint ventures. The laboratories will not need to create
the diagrams or documents again at audit, however. Therefore, instead
of the one hour we estimated that governmental laboratories would spend
developing a description or diagram that would be required under Sec.
1112.13(c)(2), we estimate, for audit purposes, that laboratories will
spend 10 minutes reviewing and updating the description or diagram.
Similarly, instead of the one hour estimated for responding to the
questionnaire that would be required under Sec. 1112.13(c)(1), we
estimate laboratories that will spend 20 minutes reviewing the document
at audit. Instead of the 30 minutes we estimated that laboratories
would spend creating a memorandum addressing undue influence that would
be required under Sec. 1112.13(c)(2)(iii), we estimate laboratories
will spend 20 minutes reviewing and updating that memorandum at audit.
A CPSC-accepted governmental laboratory stated that it took 30 minutes
to complete the attestation at audit. Instead of the 30 minutes we
estimated that a senior official would spend developing an attestation
to facts and policies concerning the applicant, as required under Sec.
1112.13(c)(2)(iv), we estimate

[[Page 31130]]

that laboratories will spend 10 minutes reviewing the attestation.
Accordingly, instead of the 180 minutes we estimated that a
governmental laboratory would spend in support of submitting the
accompanying documentation at the time of their initial application, we
estimate that a laboratory will spend 60 minutes in support of
submitting the accompanying documentation at audit (10 min. reviewing
the description or diagram + 20 min. reviewing the questionnaire + 20
min. reviewing the undue influence memorandum + 10 min. reviewing the
attestation = 60 minutes). Based on the number of governmental
laboratories that have already been accepted by the CPSC, as well as
our experience with the rate of new successful applications, we predict
that the total number of governmental laboratories will be 50. Half of
those, or 25, will be audited annually. If 25 laboratories spend 60
minutes to comply with this aspect of audit annually, that is an annual
paperwork burden of 1,500 minutes, or about 25 hours (25 laboratories x
60 minutes = 1500 minutes annually; 1500 minutes/60 minutes per hour =
25 hours).
Therefore, we estimate that the total paperwork burden associated
with our proposed amendment to the definition of audit will be about
105 hours.
Finally, we estimate that the total paperwork burden associated
with this rule will be 7,202 hours. Table 2 summarizes the estimates
and the total paperwork burden associated with this rule.

Table 2--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Frequency of Total annual Total burden, in
16 CFR Section (proposed) Number of respondents responses, percent responses Minutes per response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 1112.13(a), Baseline 450................... 25% per year, for 4 113.................. 75 minutes........... 141 hours per year.
documents--CPSC Form 223 and years.
Uploading Accreditation
Certificate and Statement of Scope.
Sec. 1112.13(a)(1), Laboratory 450................... 1% per year........... 5.................... 15 minutes........... 1.25 hours per year.
update of CPSC Form 223, whenever
any information previously
supplied on the form changes.
1112.13(b)(2), Additional 35.................... 25% per year, for 4 9.................... 506 minutes (8.4 76 hours per year.
requirements for firewalled years. hours).
applicants (6 documents to upload).
Sec. 1112.13(c)(2), Additional 50.................... 25% per year, for 4 13................... 180 minutes (3 hours) 39 hours per year.
requirements for governmental lab years.
applicants (4 requirements--upload
description/diagram; respond to
questionnaire; execute and submit
copy of memorandum; and complete
the attestation).
Sec. 1112.25(a)(2), Recordkeeping 23 (5% of 450 25% of tests 58,581 tests per year 7 minutes............ 6,834 hours per year.
requirements for subcontracted laboratories). subcontracted per that are
test reports. year (10,188 tests subcontracted.
per year, per
laboratory).
Sec. 1112.29(a), Submit 6..................... 100%.................. 6.................... 60 minutes........... 6 hours per year.
notification of voluntary
discontinuance in writing, include
5 items.
Sec. 1112.35, Adding ``and
accompanying documentation'' to
the definition of Audit.
A. Independent (baseline documents) A. 365 Independent 50% per year.......... A. 183 Independent A. 4 minutes......... A. 12.2 hours per
laboratories. laboratories. year (732 minutes
per year).
B. Firewalled laboratories......... B. 35 Firewalled ...................... B 18 Firewalled B. 226 minutes....... B. 68 hours per year
laboratories. laboratories. (4068 minutes per
year).
C. Governmental laboratories....... C. 50 Governmental ...................... C. 25 Governmental C. 60 minutes........ C. 25 hours per year
laboratories. laboratories. (1,500 minutes per
year).
Total Burden................... ...................... ...................... ..................... ..................... 7,202 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------

In compliance with the PRA, we have submitted the information
collection requirements of this rule to OMB for review. Interested
persons are requested to fax comments regarding information collection
by June 25, 2012, to the Office of Information and Regulatory Affairs,
OMB (see ADDRESSES).

VII. Environmental Considerations

The proposed rule falls within the scope of the Commission's
environmental review regulations at 16 CFR 1021.5(c)(1), which provide
a categorical exclusion from any requirement for the agency to prepare
an environmental assessment or environmental impact statement for
product certification rules.

VIII. Executive Order 12988

Executive Order 12988 (February 5, 1996), requires agencies to
state in clear language the preemptive effect, if any, of new
regulations. The proposed regulation would be issued under authority of
the CPSA and CPSIA. The CPSA provision on preemption appears at section
26 of the CPSA. The CPSIA provision on preemption appears at section
231 of the CPSIA. The

[[Page 31131]]

preemptive effect of this rule would be determined in an appropriate
proceeding by a court of competent jurisdiction.

IX. Effective Date

The Commission proposes that any final rule based on this proposed
rule become effective 90 days after its date of publication in the
Federal Register.
The requirements for CPSC acceptance of the accreditation of a
third party conformity assessment body under the final rule may differ
from the requirements currently in effect. In particular, CPSC Form 223
may change, as may the accompanying documents required with an
application. The Commission proposes to begin applying any new
application requirements, including requirements for accompanying
documents, the first time after the publication of the final rule that
a laboratory submits a CPSC Form 223. For CPSC-accepted laboratories,
their first submission of CPSC Form 223 after the 1112 final rule
publishes would likely occur at audit.

List of Subjects

16 CFR Part 1112

Administrative practice and procedure, Audit, Consumer protection,
Reporting and recordkeeping requirements, Third party conformity
assessment body.

16 CFR Part 1118

Administrative practice and procedure, Consumer protection,
Investigations.

For the reasons discussed in the preamble, the Consumer Product
Safety Commission proposes to amend 16 CFR part 1112, as added
elsewhere in this issue of the Federal Register and effective July 23,
2012, and 16 CFR part 1118 as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY
ASSESSMENT BODIES

1. The authority citation for part 1112 continues to read as
follows:

Authority: Pub. L. 110-314, section 3, 122 Stat. 3016, 3017
(2008); 15 U.S.C. 2063.

2. Amend part 1112, as added elsewhere in this issue of the Federal
Register and effective July 23, 2012, by adding 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 that are accepted by the CPSC to test children's products under
section 14 of the CPSA. It describes the requirements and procedures
for becoming a 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 the accreditation of a third party
conformity assessment body; and how an individual may submit
information alleging grounds for adverse action.
3. Amend Sec. 1112.3, as added elsewhere in this issue of the
Federal Register and effective July 23, 2012, by:
a. Revising the definitions of ``Audit'' and ``CPSC,''; and
c. Adding definitions for ``Accept accreditation,'' ``Commission,''
``CPSA,'' ``Notice of requirements,'' ``Scope,'' ``Suspend,'' ``Third
party conformity assessment body,'' ``Undue Influence,'' and
``Withdraw''
The additions read as follows:.

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 become accepted to test children's products for
conformity with a particular children's product safety rule.
* * * * *
Scope means the range of particular CPSC safety rules and/or test
methods to which a third party conformity assessment body has been
accredited and for which it may apply for CPSC acceptance.
Suspend means the CPSC has removed its acceptance, for purposes of
the testing of children's products required in section 14 of the CPSA,
of a third party conformity assessment body's accreditation for failure
to cooperate in an investigation under this part.
Third party conformity assessment body means a testing laboratory.
Undue influence means that a manufacturer, private labeler,
governmental entity, or other interested party affects a third party
conformity assessment body, such that commercial, financial, or other
pressures compromise the integrity of its testing processes or results.
Withdraw means the CPSC removes its prior acceptance of a third
party conformity assessment body's accreditation pursuant to a
particular children's product safety rule for purposes of the testing
of children's products required in section 14 of the CPSA.
4. Amend part 1112, as added elsewhere in this issue of the Federal
Register and effective July 23, 2012, by adding subpart B, to read as
follows:
Subpart B--General Requirements Pertaining to Third Party Conformity
Assessment Bodies
Sec.
1112.11 What are the types of third party conformity assessment
bodies?
1112.13 How does a third party conformity assessment body apply for
CPSC acceptance?
1112.15 When can a third party conformity assessment body apply for
CPSC acceptance for a particular CPSC rule and/or test method?

[[Page 31132]]

1112.17 How will the CPSC respond to each application?
1112.19 How does the CPSC publish information identifying third
party conformity assessment bodies that have been accepted?
1112.21 May a third party conformity assessment body use testing
methods other than those specified in the relevant CPSC rule and/or
test method?
1112.23 May a CSPC-accepted third party conformity assessment body
subcontract work conducted for purposes of section 14 of the CPSA?
1112.25 What are a third party conformity assessment body's
recordkeeping responsibilities?
1112.27 Must a third party conformity assessment body allow CPSC
inspections related to investigations?
1112.29 How does a third party conformity assessment body
voluntarily discontinue its participation with the CPSC?

Subpart B--General Requirements Pertaining to Third Party
Conformity Assessment Bodies

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;
(C) A manufacturer or private labeler of the children's product has
the ability to appoint a majority of the third party conformity
assessment body's senior internal governing body (such as, but not
limited to, a board of directors), the ability to appoint the presiding
official (such as, but not limited to, the chair or president) of the
third party conformity assessment body's senior internal governing
body, and/or the ability to hire, dismiss, or set the compensation
level for third party conformity assessment body personnel; or
(D) The third party conformity assessment body is under a contract
to a manufacturer or private labeler of the children's product that
explicitly limits the services the third party conformity assessment
body may perform for other customers and/or explicitly limits which or
how many other entities may also be customers of the third party
conformity assessment body.
(2) The children's product is subject to a CPSC children's product
safety rule that the third party conformity assessment body requests
CPSC acceptance to test; and
(3) The third party conformity assessment body intends to test such
children's product made by the owning, managing, or controlling entity
for the purpose of supporting a Children's Product Certificate.
(c) Governmental. Governmental third party conformity assessment
bodies are owned or controlled, in whole or in part, by a government.
For purposes of this part, ``government'' includes any unit of a
national, territorial, provincial, regional, state, tribal, or local
government, and a union or association of sovereign states.
``Government'' also includes domestic, as well as foreign entities. A
third party conformity assessment body is ``owned or controlled, in
whole or in part, by a government'' if any one of the following
characteristics applies:
(1) A governmental entity holds a 1 percent or greater ownership
interest, whether direct or indirect, in the third party conformity
assessment body. Indirect ownership interest is calculated by
successive multiplication of the ownership percentages for each link in
the ownership chain;
(2) A governmental entity provides any direct financial investment
or funding (other than fee for work);
(3) A governmental entity has the ability to appoint a majority of
the third party conformity assessment body's senior internal governing
body (such as, but not limited to, a board of directors); the ability
to appoint the presiding official of the third party conformity
assessment body's senior internal governing body (such as, but not
limited to, chair or president); and/or the ability to hire, dismiss,
or set the compensation level for third party conformity assessment
body personnel;
(4) Third party conformity assessment body management or technical
personnel include any government employees;
(5) The third party conformity assessment body has a subordinate
position to a governmental entity in its external organizational
structure (not including its relationship as a regulated entity to a
government regulator); or
(6) Apart from its role as regulator, the government can determine,
establish, alter, or otherwise affect:
(i) The third party conformity assessment body's testing outcomes;
(ii) The third party conformity assessment body's budget or
financial decisions;
(iii) Whether the third party conformity assessment body may accept
particular offers of work; or
(iv) The third party conformity assessment body's organizational
structure or continued existence.

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 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

[[Page 31133]]

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), and in addition to the baseline accreditation requirements in
paragraph (a) of this section, a governmental third party conformity
assessment body seeking CPSC-accepted status must submit:
(i) Description. A description illustrating the relationships with
other entities, such as government agencies and joint ventures
partners. The description may be in the form of a diagram;
(ii) Responses to questionnaires. The CPSC will provide a
governmental third party conformity assessment body applicant with a
questionnaire and will provide a separate questionnaire to the
affiliated governmental entity;
(iii) Executed memorandum. A copy of an executed memorandum
addressing undue influence;
(A) The memorandum must be:
(1) Addressed to all staff of the third party conformity assessment
body;
(2) On company letterhead;
(3) From senior management;
(4) In the primary written language used for business communication
in the area where the third party conformity assessment body is
located; if that language is different than English, an English
translation of the executed memorandum must also be provided to the
CPSC;
(5) Displayed prominently for staff reference for as long as the
accreditation of the third party conformity assessment body is accepted
by the CPSC; and
(B) The memorandum must state that:
(1) The policy of the laboratory is to reject undue influence by
any manufacturer, private labeler, governmental entity, or other
interested party, regardless of that person or entity's affiliation
with any organization;
(2) Employees are required to report immediately to their
supervisor or any other official designated by the third party
conformity assessment body about any attempts to gain undue influence;
and
(3) The third party conformity assessment body will not tolerate
violations of the undue influence policy.
(iv) Attestation. A senior officer of the governmental third party
conformity assessment body, who has the authority to make binding
statements of policy on behalf of the third party conformity assessment
body, must attest to the following:
(A) The third party conformity assessment body seeks acceptance as
a governmental third party conformity assessment body under the CPSC's
program of requirements for the testing of children's products;
(B) The official intends the attestation to be considered in
support of any and all applications made by this third party conformity
assessment body for

[[Page 31134]]

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 accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain a copy of ISO/IEC 17025:2005(E) from the
International Organization for Standardization (ISO), 1, ch. de la
Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland; Telephone
+41 22 749 01 11, Fax +41 22 733 34 30; http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883. 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 and/or test method?

(a) Once the CPSC publishes the requirements for accreditation to a
particular CPSC rule and/or test method, a third party conformity
assessment body may apply to the CPSC for acceptance to that scope of
accreditation. An application may be made for acceptance of
accreditation to more than one CPSC rule and/or test method. Once
accepted by the CPSC, a third party conformity assessment body may
apply at any time to expand the scope of its acceptance to include
additional CPSC rules or test methods. A third party conformity
assessment body may only issue test results for purposes of section 14
of the CPSA that fall within a scope for which the CPSC has accepted
the third party conformity assessment body's accreditation.
(b) The CPSC has published previously, or in the cases of 16 CFR
parts 1221, 1223, and 1224, and ASTM F 963-11 for the first time, the
requirements for accreditation for third party conformity assessment
bodies to assess conformity with the following CPSC rules and/or test
methods:
(1) 16 CFR part 1203, Safety Standard for Bicycle Helmets;
(2) 16 CFR part 1215, Safety Standard for Infant Bath Seats;
(3) 16 CFR part 1216, Safety Standard for Infant Walkers;
(4) 16 CFR part 1217, Safety Standard for Toddler Beds;

[[Page 31135]]

(5) 16 CFR part 1219, Safety Standard for Full-Size Baby Cribs;
(6) 16 CFR part 1220, Safety Standard for Non-Full-Size Baby Cribs;
(7) 16 CFR part 1221, Safety Standard for Play Yards;
(8) 16 CFR part 1223, Safety Standard for Infant Swings
(9) 16 CFR part 1224, Safety Standard for Portable Bedrails;
(10) 16 CFR part 1303, Ban of 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 and/or CPSC-
CH-E1003-09.1;
(ii) ASTM F 2853-10, ``Standard Test Method for Determination of
Lead in Paint Layers and Similar Coatings or in Substrates and
Homogenous Materials by Energy Dispersive X-Ray Fluorescence
Spectrometry Using Multiple Monochromatic Excitation Beams.''
(11) 16 CFR part 1420, Safety Standard for All-Terrain Vehicles;
(12) 16 CFR 1500.86(a)(5), Exceptions from Classification as a
Banned Toy or Other Banned Article for Use by Children (Clacker Balls);
(13) 16 CFR 1500.86(a)(7) and (8), Exceptions from Classification
as a Banned Toy or Other Banned Article for Use by Children (Dive
Sticks and Similar Articles);
(14) 16 CFR part 1501, Method for Identifying Toys and Other
Articles Intended for Use by Children Under 3 Years of Age Which
Present Choking, Aspiration, or Ingestion Hazards Because of Small
Parts;
(15) 16 CFR part 1505, Requirements for Electrically Operated Toys
or Other Electrically Operated Articles Intended for Use by Children;
(16) 16 CFR part 1510, Requirements for Rattles;
(17) 16 CFR part 1511, Requirements for Pacifiers;
(18) 16 CFR part 1512, Requirements for Bicycles;
(19) 16 CFR part 1513, Requirements for Bunk Beds;
(20) 16 CFR part 1610, Standard for the Flammability of Clothing
Textiles;
(21) 16 CFR part 1611, Standard for the Flammability of Vinyl
Plastic Film;
(22) 16 CFR part 1615, Standard for the Flammability of Children's
Sleepwear: Sizes 0 Through 6X (FF 3-71);
(23) 16 CFR part 1616, Standard for the Flammability of Children's
Sleepwear: Sizes 7 Through 14 (FF 5-74);
(24) 16 CFR part 1630, Standard for the Surface Flammability of
Carpets and Rugs (FF 1-70);
(25) 16 CFR part 1631, Standard for the Surface Flammability of
Small Carpets and Rugs (FF 2-70);
(26) 16 CFR part 1632, Standard for the Flammability of Mattresses
and Mattress Pads (FF 4-72, amended);
(27) 16 CFR part 1633, Standard for the Flammability (Open Flame)
of Mattress Sets;
(28) Lead Content in Children's Metal Jewelry. For its
accreditation to be accepted by the Commission to test for lead content
in children's metal jewelry, a third party conformity assessment body
must have one or more of the following test methods referenced in its
statement of scope:
(i) CPSC Test Method CPSC-CH-E1001-08, ``Standard Operating
Procedure for Determining Total Lead (Pb) in Children's Metal Products
(Including Children's Metal Jewelry)''; and/or the revision CPSC Test
Method CPSC-CH-E1001-08.1, ``Standard Operating Procedure for
Determining Total Lead (Pb) in Children's Metal Products (Including
Children's Metal Jewelry)''; and/or
(ii) Section I, ``Screening Test for Total Pb Analysis,'' from CPSC
``Standard Operating Procedure for Determining Lead (Pb) and its
Availability in Children's Metal Jewelry,'' dated February 3, 2005;
(29) Limits on Total Lead in Children's Products: Children's Metal
Products. For its accreditation to be accepted by the Commission to
test for total lead content in children's metal products, a third party
conformity assessment body must have one or more of the following test
methods referenced in its statement of scope: CPSC Test Method CPSC-CH-
E1001-08, ``Standard Operating Procedure for Determining Total Lead
(Pb) in Children's Metal Products (Including Children's Metal
Jewelry)''; and/or the, revision CPSC Test Method CPSC-CH-E1001-08.1,
``Standard Operating Procedure for Determining Total Lead (Pb) in
Children's Metal Products (Including Children's Metal Jewelry''; and/or
the revision of that test method ((Test Method CPSC-CH-E1001-08.2);
(30) Limits on Total Lead in Children's Products: Non-Metal
Children's Products. For its accreditation to be accepted by the
Commission to test for lead content in non-metal children's products, a
third party conformity assessment body must have one or more of the
following test methods referenced in its statement of scope: CPSC Test
Method CPSC-CH-E1002-08, ``Standard Operating Procedure for Determining
Total Lead (Pb) in Non-Metal Children's Products''; and/or the revision
CPSC Test Method CPSC-CH-E1002-08.1, ``Standard Operating Procedure for
Determining Total Lead (Pb) in Non-Metal Children's Products''; and/or
the revision of that test method ((Test Method CPSC-CH-E1002-08.2);
(31) Limits on Phthalates in Children's Toys and Child Care
Articles. For its accreditation to be accepted by the Commission to
test for phthalates in children's toys and child care articles, a third
party conformity assessment body must have one or more of the following
test methods referenced in its statement of scope:
(i) CPSC Test Method CPSC-CH-1001-09.3, ``Standard Operating
Procedure for Determination of Phthalates;'' and/or
(ii) GB/T 22048-2008, ``Toys and Children's Products--Determination
of Phthalate Plasticizers in Polyvinyl Chloride Plastic;''
(32) ASTM International's Standard Consumer Safety Specification
for Toy Safety, F 963-11, and section 4.27 (toy chests) from ASTM
International's Standard Consumer Safety Specification for Toy Safety,
F 963-07[epsi]1. The CPSC only requires certain provisions of ASTM F
963-11 and Section 4.27 of ASTM F 963-07[epsi]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 F 963-07[epsi]1; Section 4.27--Toy Chests (except labeling
and/or instructional literature requirements)
(ii) ASTM F 963-11
(A) Section 4.3.5.1(2), Surface Coating Materials--Soluble Test for
Metals
(B) Section 4.3.5.2,Toy Substrate Materials
(C) Section 4.3.6.3, Cleanliness of Liquids, Pastes, Putties, Gels,
and Powders (except for cosmetics and tests on formulations used to
prevent microbial degradation)
(D) Section 4.3.7, Stuffing Materials
(E) Section 4.5, Sound Producing Toys
(F) Section 4.6, Small Objects (except labeling and/or
instructional literature requirements)
(G) Section 4.7, Accessible Edges (except labeling and/or
instructional literature requirements)
(H) Section 4.8, Projections (except bath toy projections)

[[Page 31136]]

(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 this section in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may inspect a copy of the standards
incorporated in this section at the Office of the Secretary, U.S.
Consumer Product Safety Commission, Room 820, 4330 East West Highway,
Bethesda, MD 20814, telephone 301-504-7923, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741- 6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(1) ASTM F 2853-10, ``Standard Test Method for Determination of
Lead in Paint Layers and Similar Coatings or in Substrates and
Homogenous Materials by Energy Dispersive X-Ray Fluorescence
Spectrometry Using Multiple Monochromatic Excitation Beams.''
(2) GB/T 22048-2008, ``Toys and Children's Products--Determination
of Phthalate Plasticizers in Polyvinyl Chloride Plastic.''

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 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.

Sec. 1112.21 May a third party conformity assessment body use testing
methods other than those specified in the relevant CPSC rule and/or
test method?

If the CPSC has specified a test method, a third party conformity
assessment body must use that test method for any tests conducted for
purposes of section 14 of the CPSA.

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 that
have been accepted by the CPSC for the scope necessary for the
subcontracted work. Violation of this provision constitutes
compromising the integrity of the testing process and may be grounds
for withdrawal of the CPSC's acceptance of the accreditation of the
prime and/or subcontracting third party conformity assessment body.
(b) The provisions of this part apply to all CPSC-accepted third
party conformity assessment bodies, even if they are a prime contractor
and/or a subcontractor.

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 appended to the prime contractor's test report.
(3) Where a report, for purposes of section 14 of the CPSA,
provided by the third party conformity assessment body to a customer is
different from the test record, the third party conformity assessment
body also must retain the report provided to the customer for a

[[Page 31137]]

period of at least five years from the date the test was conducted.
(4) Any and all third party conformity assessment body internal
documents describing testing protocols and procedures (such as
instructions, standards, manuals, guides, and reference data) that have
applied to a test conducted for purposes of section 14 of the CPSA must
be retained for a period of at least five years from the date such test
was conducted.
(b) Upon request by the CPSC, the third party conformity assessment
body must make any and all of the records required by this section
available for inspection, either in hard copy or electronic form,
within 48 hours. If the records are not in the English language, the
third party conformity assessment body must make copies of the original
(non-English language) available to the CPSC within 48 hours, and they
must make an English translation of the records available to the CPSC
within 30 calendar days of the date the CPSC requested an English
translation.

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;
(4) Statement that the third party conformity assessment body
understands that it must reapply for acceptance of the accreditation
scope for which it is requesting discontinuance; and
(5) Verification that the person requesting the discontinuance has
the authority to make such a request on behalf of the third party
conformity assessment body.
(b) The CPSC may verify the information submitted in a notice of
voluntary discontinuance.
(c) Upon receipt of a notice from a third party conformity
assessment body that it wishes to discontinue voluntarily as a CPSC-
accepted third party conformity assessment body, or after verifying the
information in a notice, the CPSC will update its Web site to indicate
that the CPSC no longer accepts the accreditation of the third party
conformity assessment body for the scope indicated, as of the date
provided in the notice.
(d) Notwithstanding a third party conformity assessment body's
voluntary discontinuance as a CPSC-accepted third party conformity
assessment body, the CPSC may begin or continue an investigation
related to an adverse action under this part, or other legal action.
5. Amend Sec. 1112.35, as added elsewhere in this issue of the
Federal Register and effective July 23, 2012, by adding paragraph (b)
to read as follows:

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.
6. Amend part 1112, as added elsewhere in this issue of the Federal
Register and effective July 23, 2012, by adding subpart D to read as
follows:
Subpart D--Adverse Actions: Types, Grounds, Allegations, Procedural
Requirements, and Publication
Sec.
1112.41 What are the possible adverse actions the CPSC may take
against a third party conformity assessment body?
1112.43 What are the grounds for denial of an application?
1112.45 What are the grounds for suspension of CPSC acceptance?
1112.47 What are the grounds for withdrawal of CPSC acceptance?
1112.49 How may a person submit information alleging grounds for
adverse action, and what information should be submitted?
1112.51 What are the procedures relevant to adverse actions?
1112.53 Can the CPSC immediately withdraw its acceptance of the
accreditation of a third party conformity assessment body?
1112.55 Will the CPSC publish adverse actions?

Subpart D--Adverse Actions: Types, Grounds, Allegations, Procedural
Requirements, and Publication

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

[[Page 31138]]

accordance with Sec. 1112.53 of this subpart.

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 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 of this subpart.

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.

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 above.

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 of this subpart.
(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

[[Page 31139]]

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 for why the CPSC should
not pursue the proposed adverse action, or any portion of the proposed
adverse action. If a third party conformity assessment body responds to
the notice in a timely manner, the CPSC will review the response, and,
if necessary, investigate further to explore or resolve issues bearing
on whether grounds exist for adverse action and the nature of the
proposed adverse action. If a third party conformity assessment body
does not respond to the notice in a timely manner, the CPSC may proceed
without further delay to a Final Notice, as described in paragraph (e)
of this section.
(d) Proceeding. (1) In any proceeding to withdraw the CPSC's
acceptance of a third party conformity assessment body's accreditation,
the CPSC will consider the gravity of the third party conformity
assessment body's action or failure to act, including:
(i) Whether the action or failure to act resulted in injury, death,
or the risk of injury or death;
(ii) Whether the action or failure to act constitutes an isolated
incident or represents a pattern or practice; and
(iii) Whether and when the third party conformity assessment body
initiated remedial action.
(2) In all cases, the CPSC will review and take under advisement
the response provided by the third party conformity assessment body.
Except for cases under paragraph (d)(3) of this section, the CPSC will
determine what action is appropriate under the circumstances.
(3) If, after reviewing and taking under advisement the response
provided by a CPSC-accepted firewalled third party conformity
assessment body, the CPSC staff concludes that suspension or withdrawal
of CPSC acceptance of accreditation is appropriate, staff will transmit
their recommendation to the Commission for consideration. Any
suspension or withdrawal of CPSC acceptance of accreditation of a
firewalled third party conformity assessment body (including immediate
and temporary withdrawal under 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, 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.

[[Page 31140]]

(iv) If an Administrative Appeal is timely filed, the Executive
Director will issue a Final Decision within 60 calendar days of
receipt. If the Executive Director's Final Decision requires more than
60 calendar days, he or she will notify the third party conformity
assessment body that more time is required, state the reason(s) why
more time is required, and, if feasible, include an estimated date for
a Final Decision to issue.
(2) In the case that the Commission has suspended or withdrawn its
acceptance of the accreditation of a firewalled third party conformity
assessment body, the firewalled third party conformity assessment body
may file an Administrative Appeal with the Commission.
(i) The Administrative Appeal must be sent, by mail, within 30
calendar days of the date on the Final Notice to: The Office of the
Secretary, Room 820, U.S. Consumer Product Safety Commission, 4330 East
West Highway, Bethesda, MD 20814, or by electronic mail to: cpsc-os@cpsc.gov.
(ii) All appeals must be in writing, in English.
(iii) All appeals must explain the nature of the issues appealed
from in the Final Decision, and must describe in detail the reasons why
the third party conformity assessment body believes that no ground(s)
for adverse action exist.

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 of this subpart.
(1) For purposes of this part, ``in the public interest to protect
health and safety'' means that the CPSC has credible evidence that:
(i) The integrity of test(s) being conducted under a scope for
which the CPSC has accepted the third party conformity assessment
body's accreditation, have been affected by undue influence or
otherwise interfered with or compromised; and
(ii) The scope for which the CPSC has accepted the third party
conformity assessment body's accreditation involve a product(s) which,
if noncompliant with CPSC rules, bans, standards, and/or regulations,
constitutes an imminently hazardous consumer product under section 12
of the CPSA.
(2) When presented with an allegation that, if credible, would
result in immediate and temporary withdrawal of CPSC acceptance of a
third party conformity assessment body's accreditation, the
investigation and adverse action procedures described in 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 of this subpart, the immediate and temporary withdrawal will
remain in effect until: The agency communicates in writing that the
immediate and temporary withdrawal has been lifted; the investigation
concludes and the agency does not propose an adverse action; or the
adverse action process concludes with denial, suspension, or
withdrawal.
(c) If the third party conformity assessment body is not already
the subject of an investigation or adverse action process under Sec.
1112.51 of this subpart, 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

7. The authority citation for part 1118 is revised to read as
follows:

Authority: 15 U.S.C. 2063; 15 U.S.C. 2065; 15 U.S.C. 2068; 15
U.S.C. 2076; sec. 3, Pub. L. 110-314, 122 Stat. 3016.

8. Amend 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) Is required by the Commission to be established, made or
maintained, or
(ii) Show or relate to the production, inventory, testing,
distribution, sale, transportation, importation, or receipt of any
product, or that are otherwise relevant to determining whether any
person or firm has acted or is acting in compliance with the Act and
regulations, rules, and orders promulgated under the Act, and
(4) To obtain:
(i) Information, both oral and written, concerning the production,
inventory, testing, distribution, sale, transportation, importation, or
receipt of any product, and the organization, business, conduct,
practices, and management of any person or firm being inspected and its
relation to any other person or firm;
(ii) Samples of items, materials, substances, products, containers,
packages and packaging, and labels and labeling, or any component at
manufacturer's, distributor's, third party conformity assessment
body's, or retailer's cost, unless voluntarily provided; and

[[Page 31141]]

(iii) Information, both oral and written, concerning any matter
referred to in the Act and these rules.
* * * * *

Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-10923 Filed 5-23-12; 8:45 am]
BILLING CODE 6355-01-P