82_FR_49974 82 FR 49767 - CPSC Acceptance of Third Party Laboratories: Revision to the Notice of Requirements for Prohibitions of Children's Toys and Child Care Articles Containing Specified Phthalates

82 FR 49767 - CPSC Acceptance of Third Party Laboratories: Revision to the Notice of Requirements for Prohibitions of Children's Toys and Child Care Articles Containing Specified Phthalates

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 82, Issue 207 (October 27, 2017)

Page Range49767-49770
FR Document2017-23266

This notice of proposed rulemaking (NPR) would update the existing notice of requirements (NOR) for prohibitions of children's toys and child care articles containing specified phthalates that provide the criteria and process for Commission acceptance of accreditation pursuant to the Consumer Product Safety Act (CPSA). The proposed NOR would revise the current NOR to be consistent with the final phthalates rule, which is published elsewhere in this same issue of the Federal Register and will be codified in the Code of Federal Regulations (CFR).

Federal Register, Volume 82 Issue 207 (Friday, October 27, 2017)
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Proposed Rules]
[Pages 49767-49770]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-23266]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2017-0043]

16 CFR Part 1112


CPSC Acceptance of Third Party Laboratories: Revision to the 
Notice of Requirements for Prohibitions of Children's Toys and Child 
Care Articles Containing Specified Phthalates

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: This notice of proposed rulemaking (NPR) would update the 
existing notice of requirements (NOR) for prohibitions of children's 
toys and child care articles containing specified phthalates that 
provide the criteria and process for Commission acceptance of 
accreditation pursuant to the Consumer Product Safety Act (CPSA). The 
proposed NOR would revise the current NOR to be consistent with the 
final phthalates rule, which is published elsewhere in this same issue 
of the Federal Register and will be codified in the Code of Federal 
Regulations (CFR).

DATES: Submit comments by January 10, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2017-
0043, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: http://www.regulations.gov. Follow the 
instructions for submitting comments. The Commission does not accept 
comments submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Office of the Secretary, 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

[[Page 49768]]

docket number for this notice. All comments received may be posted 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. 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, and insert the 
docket number CPSC-2017-0043, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Scott R. Heh, Project Manager, 
Directorate for Laboratory Sciences, Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-504-
7646; email: [email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    Section 108 of the Consumer Product Safety Improvement Act of 2008 
(CPSIA) established requirements concerning concentration limits for 
specified phthalates in children's toys and child care articles. In 
this same issue of the Federal Register, the Commission is publishing a 
final rule that changes some of the statutory phthalate restrictions 
currently in place pursuant to section 108(b)(3) of the CPSIA. 15 
U.S.C. 2063c(a). The Commission's phthalates rule makes permanent the 
interim prohibition on children's toys that can be placed in a child's 
mouth and child care articles that contain concentrations of more than 
0.1 percent of diisononyl phthalate (DINP). The phthalates rule extends 
this prohibition to cover all children's toys and child care articles 
containing concentrations of more than 0.1 percent of DINP. The 
phthalates rule also lifts the interim prohibitions on children's toys 
that can be placed in a child's mouth and child care articles that 
contain concentrations of more than 0.1 percent of di-n-octyl phthalate 
(DNOP) or diisodecyl phthalate (DIDP). In addition, the phthalates rule 
prohibits children's toys and child care articles that contain 
concentrations of more than 0.1 percent of diisobutyl phthalate (DIBP), 
Di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and 
dicyclohexyl phthalate (DCHP). The permanent prohibitions on children's 
toys and child care articles that contain concentrations of more than 
0.1 percent on the use of di-(2-ethylhexyl) phthalate (DEHP), dibutyl 
phthalate (DBP), and benzyl butyl phthalate (BBP) in children's toys 
and child care articles in section 108 of the CPSIA are unchanged by 
the phthalate rule.
    Because the phthalates rule revises the list of statutorily 
prohibited phthalates in children's toys and child care articles in 
section 108 of the CPSIA, this NPR proposes to amend the existing NOR 
for the prohibitions of children's toys and child care articles 
containing specified phthalates to reflect those changes.

B. Notice of Requirements

    Section 14(a) of the CPSA requires that products subject to a 
consumer product safety rule under the CPSA, or to a similar rule, ban, 
standard, or regulation under any other act enforced by the Commission, 
be certified as complying with all applicable CPSC requirements. 15 
U.S.C. 2063(a). Such certification must be based on a test of each 
product, or on a reasonable testing program or, for children's 
products, on tests of a sufficient number of samples by a third party 
conformity assessment body accredited by the Commission to test 
according to the applicable requirements. The Commission's phthalates 
rule is considered a ``consumer product safety standard.'' 15 U.S.C. 
2063c(f). Thus, products subject to the phthalates rule are subject to 
the testing and certification requirements of section 14 of the CPSA.
    Because children's toys and child care articles are children's 
products, samples of these products must be tested by a third party 
conformity assessment body whose accreditation has been accepted by the 
Commission. These products also must comply with all other applicable 
CPSC requirements, such as the lead content requirements of section 101 
of the CPSIA, the requirements of the toy standard, 16 CFR part 1250, 
and the tracking label requirement in section 14(a)(5) of the CPSA.
    In accordance with section 14(a)(3)(B)(vi) of the CPSIA, the 
Commission has previously published two NORs for accreditation of third 
party conformity assessment bodies for testing children's toys and 
child care articles under section 108 of the CPSIA (76 FR 49286 (Aug. 
10, 2011), 78 FR 15836 (March 12, 2013)).
    If the Commission finalizes the NOR as proposed, the following 
process would be used during the transition period from test method 
CPSC-CH-C1001-09.3 (2010) to a revised version of the method, currently 
titled, draft test method CPSC-CH-C1001-09.4 (2017). CPSC would accept 
testing to support children's toys and child care article 
certifications to the new phthalates prohibitions if the laboratory is 
already CPSC-accepted to test to CPSC-CH-C1001-09.3 (2010). 
Laboratories that conduct testing to support product certifications to 
the new phthalates prohibitions must list in their test reports ``16 
CFR part 1307'' and CPSC-CH-C1001-09.3 until laboratories have 
transitioned their accreditation scope and CPSC listing to CPSC-CH-
C1001-09.4.
    The CPSC would open the laboratory application process for draft 
test method CPSC-CH-C1001-09.4 (2017) on the date the final NOR rule is 
published in the Federal Register. Laboratories that seek CPSC 
acceptance to the revised prohibitions for children's toys and child 
care articles in 16 CFR part 1307 would be required to update their 
accreditation scope. To be CPSC-accepted, a laboratory's scope of 
accreditation must include the reference to draft CPSC-CH-C1001-09.4 
(2017). Laboratories that are currently CPSC-accepted to CPSC-CH-C1001-
09.3 (2010) would be instructed to update their accreditation scope to 
include draft CPSC-CH-C1001-09.4 (2017) as soon as possible, and submit 
their application for CPSC acceptance. Laboratories that were not 
previously CPSC-accepted to CPSC-CH-C1001-09.3 (2010) would be 
instructed to work with their accreditation bodies to include ``CPSC-
CH-C1001-09.4 (2017)'' in their scope documents.
    CPSC would accept testing results to the new phthalates 
prohibitions in 16 CFR part 1307 from laboratories that are CPSC-
accepted to CPSC-CH-C1001-09.3 (2010) for two years from the date of 
publication of the final rule NOR in the Federal Register. This should 
allow adequate time for laboratories to work with their accreditation 
bodies to make official updates to their accreditation scope document 
to include the revised CPSC method ``CPSC-CH-C1001-09.4 (2017)'' and 
submit applications to the CPSC. Two years after the date the final 
rule NOR publishes in the Federal Register, the CPSC will no longer 
accept laboratory applications that reference CPSC-CH-C1001-09.3 
(2010), and any application to CPSC must reference ``CPSC-CH-C1001-09.4 
(2017).''

C. Description of the Proposed Rule

    The proposed rule would amend 16 CFR 1112(b)(31), (31)(i) and 
(c)(3)(i) to update the references to reflect the promulgation of 16 
CFR part 1307 and draft CPSC test method CPSC-CH-C1001-09.4 (2017). The 
draft test method would provide detailed

[[Page 49769]]

information on testing that will be used by the CPSC testing laboratory 
for the analysis of phthalate content in children's toys and child care 
articles. CPSC staff has determined that using an appropriate 
combination of the methods of extraction and analysis presented in the 
test method is sufficient to determine the concentration of the 
regulated phthalates in most children's toys and child care articles. 
The general approach is to dissolve the sample completely in 
tetrahydrofuran, precipitate any PVC polymer with a second solvent, 
then analyze by Gas Chromatography-Mass Spectrometry (GC-MS). The draft 
test method provides definitions, a list of equipment and supplies 
needed for testing, procedures to measure phthalate concentration, 
instructions for sample preparation, and descriptions of the phthalate 
extraction method and instrument parameters. The draft test method is 
available at Tab A of the CPSC staff's briefing package available on 
CPSC's Web site at: https://www.cpsc.gov/s3fs-public/Notice%20of%20Proposed%20Rulemaking%20for%20NOR%20for%20Phthalates%20-%20September%2013%202017.pdf?pH5_n4seuAb0.USRYqPfsnmLuTKC8F_2. Draft 
CPSC test method CPSC-CH-C1001-09.4 (2017) has been updated to reflect 
the list of phthalates prohibited in children's toys and child care 
articles in 16 CFR part 1307 ((di(2-ethylhexyl) phthalate (DEHP), 
dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), di-n-octyl 
phthalate (DNOP) diisobutyl phthalate (DIBP), di-n-pentyl phthalate 
(DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate 
(DCHP)). The draft test method CPSC-CH-C1001-09.4 (2017) is 
substantially the same as the current testing procedure. The Commission 
encourages comments on draft CPSC test method CPSC-CH-C1001-09.4 
(2017). We note that the draft test method could change in the final 
rule.

D. Effective Date

    The APA generally requires that a substantive rule must be 
published not less than 30 days before its effective date. 5 U.S.C. 
553(d)(1). Because the proposed rule would allow testing to continue 
under the existing testing method by testing laboratories that meet 
certain criteria for a period of up to two years after the publication 
of a final rule, the Commission proposes a 30 day effective date for 
the final rule.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to prepare 
a regulatory flexibility analysis for any rule subject to notice and 
comment rulemaking requirements under the APA, or any other statute, 
unless the agency certifies that the rulemaking will not have a 
significant economic impact on a substantial number of small entities. 
5 U.S.C. 603 and 605. Small entities include small businesses, small 
organizations, and small governmental jurisdictions.
    The impact of the proposed rule on small testing laboratories would 
be minimal. The only laboratories that would be impacted are those that 
offer to test children's toys and child care articles for prohibited 
phthalates. These laboratories are already accredited by one or more 
accreditation bodies that are signatories to the International 
Laboratory Accreditation Cooperation--Mutual Recognition Arrangement 
(ILAC-MRA) and have had their accreditations accepted by the 
Commission. These laboratories would have to revise their procedures 
for testing for phthalate content to be consistent with the revised 
phthalate test method (CPSC-CH-C1001-09.4) which would replace the 
current phthalate test method (CPSC-CH-C1001-09.3) if the proposed NOR 
is finalized. Staff expects that the impact of revising testing 
procedures will be low for qualified laboratories because the same 
sample preparation, extraction methods, and equipment is used for both 
methods. Moreover, the additional phthalates included in draft CPSC-CH-
C1001-09.4 can be isolated at unique elution times by gas 
chromatography and, therefore, the analysis should not be a burden for 
those qualified to perform such testing.
    Additionally, within two years of the publication of the final NOR 
rule, laboratories would need to update their scope accreditation 
documents to include the revised phthalate test method (CPSC-CH-C1001-
09.4). Staff expects that the burden of this requirement will also be 
low because testing laboratories typically must undergo a reassessment 
every two years in order to maintain their accreditations. Updating the 
accreditation scope documents to include the revised phthalate test 
method is a minor change and should result in little or no additional 
cost to a testing laboratory if completed during the periodic 
reassessment, which the 2-year window would allow testing laboratories 
to do.
    After considering the economic impacts of this proposed rule on 
small entities, the Commission certifies that the proposed rule would 
not have a significant economic impact on a substantial number of small 
entities.

F. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). This rule falls within the categorical exclusion, so no 
environmental assessment or environmental impact statement is required.

List of Subjects in 16 CFR Part 1112

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

    For the reasons discussed in the preamble, the Commission proposes 
to amend Title 16 CFR chapter II, as follows:

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

0
1. The authority citation for part 1112 continues to read as follows:

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

0
2. Amend Sec.  1112.15 by:
0
a. Revising the introductory text to paragraph (b)(31);
0
b. Revising paragraph (b)(31)(i); and
0
c. Revising paragraph (c)(3)(i).
    The revisions read as follows:


Sec.  1112.15  When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (31) 16 CFR part 1307, Prohibition of Children's Toys and Child 
Care Articles Containing Specified Phthalates. 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-1001-09.4, ``Standard Operating 
Procedure for Determination of Phthalates;
* * * * *
    (c) * * *
    (3) * * *

[[Page 49770]]

    (i) CPSC-CH-C1001-9.4, ``Standard Operating Procedure for 
Determination of Phthalates'', September 1, 2017.
* * * * *

Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2017-23266 Filed 10-26-17; 8:45 am]
BILLING CODE 6355-01-P



                                                                              Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules                                              49767

                                                      must comply with the requirements                       planning, assessment of capital                       period starting October 15 and ending
                                                      applicable to a $50 billion or over                     adequacy, and risk management                         October 31.
                                                      covered institution beginning on                        practices.                                            *    *     *     *    *
                                                      January 1 of the third calendar year after              ■ 6. Section 46.7 is amended by revising
                                                                                                                                                                      Dated: October 19, 2017.
                                                      the national bank or Federal savings                    paragraphs (a) and (b) to read as follows:
                                                                                                                                                                    Keith A. Noreika,
                                                      association becomes a $50 billion or
                                                      over covered institution, unless that                   § 46.7 Reports to the Office of the                   Acting Comptroller of the Currency.
                                                                                                              Comptroller of the Currency and the Board             [FR Doc. 2017–23353 Filed 10–26–17; 8:45 am]
                                                      time is extended by the OCC in writing.                 of Governors of the Federal Reserve
                                                      A national bank or Federal savings                      System.
                                                                                                                                                                    BILLING CODE 4810–33–P
                                                      association that becomes a $50 billion or
                                                                                                                (a) $10 to $50 billion covered
                                                      over covered institution on or before
                                                                                                              institution. A $10 to $50 billion covered
                                                      September 30 of a calendar year must                                                                          CONSUMER PRODUCT SAFETY
                                                                                                              institution must report to the OCC and
                                                      comply with the requirements                                                                                  COMMISSION
                                                                                                              to the Board of Governors of the Federal
                                                      applicable to a $50 billion or over
                                                      covered institution beginning on                        Reserve System, on or before July 31,                 [Docket No. CPSC–2017–0043]
                                                      January 1 of the second calendar year                   the results of the stress test in the
                                                                                                              manner and form specified by the OCC.                 16 CFR Part 1112
                                                      after the national bank or Federal
                                                                                                                (b) $50 billion or over covered
                                                      savings association becomes a $50                                                                             CPSC Acceptance of Third Party
                                                      billion or over covered institution,                    institution. A $50 billion or over
                                                                                                                                                                    Laboratories: Revision to the Notice of
                                                      unless that time is extended by the OCC                 covered institution must report to the
                                                                                                                                                                    Requirements for Prohibitions of
                                                      in writing.                                             OCC and to the Board of Governors of
                                                                                                                                                                    Children’s Toys and Child Care
                                                                                                              the Federal Reserve System, on or before
                                                      *      *    *     *     *                                                                                     Articles Containing Specified
                                                                                                              April 5, the results of the stress test in
                                                      ■ 5. Revise § 46.5 to read as follows:                                                                        Phthalates
                                                                                                              the manner and form specified by the
                                                      § 46.5   Annual stress test.                            OCC.                                                  AGENCY: Consumer Product Safety
                                                         Each covered institution must                        *     *     *     *     *                             Commission.
                                                      conduct the annual stress test under this               ■ 7. Section 46.8 is amended by revising              ACTION: Notice of proposed rulemaking.
                                                      part subject to the following                           paragraph (a) to read as follows:
                                                      requirements:                                                                                                 SUMMARY:   This notice of proposed
                                                         (a) Financial data. A covered                        § 46.8   Publication of disclosures.                  rulemaking (NPR) would update the
                                                      institution must use financial data as of                  (a) Publication date. (1) $50 billion or           existing notice of requirements (NOR)
                                                      December 31 of the previous calendar                    over covered institution. A $50 billion               for prohibitions of children’s toys and
                                                      year.                                                   or over covered institution must publish              child care articles containing specified
                                                         (b) Scenarios provided by the OCC. In                a summary of the results of its annual                phthalates that provide the criteria and
                                                      conducting the stress test under this                   stress test in the period starting June 15            process for Commission acceptance of
                                                      part, each covered institution must use                 and ending July 15 provided:                          accreditation pursuant to the Consumer
                                                      the scenarios provided by the OCC. The                     (i) Unless the OCC determines                      Product Safety Act (CPSA). The
                                                      scenarios provided by the OCC will                      otherwise, if the $50 billion or over                 proposed NOR would revise the current
                                                      reflect a minimum of three sets of                      covered institution is a consolidated                 NOR to be consistent with the final
                                                      economic and financial conditions,                      subsidiary of a bank holding company                  phthalates rule, which is published
                                                      including baseline, adverse, and                        or savings and loan holding company                   elsewhere in this same issue of the
                                                      severely adverse scenarios. The OCC                     subject to supervisory stress tests                   Federal Register and will be codified in
                                                      will provide a description of the                       conducted by the Board of Governors of                the Code of Federal Regulations (CFR).
                                                      scenarios required to be used by each                   the Federal Reserve System pursuant to                DATES: Submit comments by January 10,
                                                      covered institution no later than                       12 CFR part 252, then within the June                 2018.
                                                      February 15 of that calendar year.                      15 to July 15 period such covered                     ADDRESSES: You may submit comments,
                                                         (c) Significant trading activities. The              institution may not publish the required              identified by Docket No. CPSC–2017–
                                                      OCC may require a covered institution                   summary of its annual stress test earlier             0043, by any of the following methods:
                                                      with significant trading activities, as                 than the date that the Board of                         Electronic Submissions: Submit
                                                      determined by the OCC, to include                       Governors of the Federal Reserve                      electronic comments to the Federal
                                                      trading and counterparty components in                  System publishes the supervisory stress               eRulemaking Portal at: http://
                                                      its adverse and severely adverse                        test results of the covered bank’s parent             www.regulations.gov. Follow the
                                                      scenarios. The trading and counterparty                 holding company.                                      instructions for submitting comments.
                                                      position data to be used in this                           (ii) If the Board of Governors of the              The Commission does not accept
                                                      component will be as of a date between                  Federal Reserve System publishes the                  comments submitted by electronic mail
                                                      October 1 of the previous calendar year                 supervisory stress test results of the                (email), except through
                                                      and March 1 of that calendar year in                    covered institution’s parent holding                  www.regulations.gov. The Commission
                                                      which the stress test is performed, and                 company prior to June 15, then such                   encourages you to submit electronic
                                                      the OCC will communicate a                              covered institution may publish its                   comments by using the Federal
                                                      description of the component to the                     stress test results prior to June 15, but
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS




                                                                                                                                                                    eRulemaking Portal, as described above.
                                                      covered institution no later than March                 no later than July 15, through actual                   Written Submissions: Submit written
                                                      1 of that calendar year.                                publication by the covered institution or             submissions by mail/hand delivery/
                                                         (d) Use of stress test results. The board            through publication by the parent                     courier to: Office of the Secretary,
                                                      of directors and senior management of                   holding company pursuant to paragraph                 Consumer Product Safety Commission,
                                                      each covered institution must consider                  (b) of this section.                                  Room 820, 4330 East West Highway,
                                                      the results of the stress tests conducted                  (2) $10 to $50 billion covered                     Bethesda, MD 20814; telephone (301)
                                                      under this section in the normal course                 institution. A $10 to $50 billion covered             504–7923.
                                                      of business, including but not limited to               institution must publish a summary of                   Instructions: All submissions received
                                                      the covered institution’s capital                       the results of its annual stress test in the          must include the agency name and


                                                 VerDate Sep<11>2014   16:36 Oct 26, 2017   Jkt 244001   PO 00000   Frm 00004   Fmt 4702   Sfmt 4702   E:\FR\FM\27OCP1.SGM   27OCP1


                                                      49768                   Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules

                                                      docket number for this notice. All                      concentrations of more than 0.1 percent               CPSC would accept testing to support
                                                      comments received may be posted                         on the use of di-(2-ethylhexyl) phthalate             children’s toys and child care article
                                                      without change, including any personal                  (DEHP), dibutyl phthalate (DBP), and                  certifications to the new phthalates
                                                      identifiers, contact information, or other              benzyl butyl phthalate (BBP) in                       prohibitions if the laboratory is already
                                                      personal information provided, to:                      children’s toys and child care articles in            CPSC-accepted to test to CPSC–CH–
                                                      http://www.regulations.gov. Do not                      section 108 of the CPSIA are unchanged                C1001–09.3 (2010). Laboratories that
                                                      submit confidential business                            by the phthalate rule.                                conduct testing to support product
                                                      information, trade secret information, or                 Because the phthalates rule revises                 certifications to the new phthalates
                                                      other sensitive or protected information                the list of statutorily prohibited                    prohibitions must list in their test
                                                      that you do not want to be available to                 phthalates in children’s toys and child               reports ‘‘16 CFR part 1307’’ and CPSC–
                                                      the public. If furnished at all, such                   care articles in section 108 of the CPSIA,            CH–C1001–09.3 until laboratories have
                                                      information should be submitted in                      this NPR proposes to amend the existing               transitioned their accreditation scope
                                                      writing.                                                NOR for the prohibitions of children’s                and CPSC listing to CPSC–CH–C1001–
                                                         Docket: For access to the docket to                  toys and child care articles containing               09.4.
                                                      read background documents or                            specified phthalates to reflect those                    The CPSC would open the laboratory
                                                      comments received, go to: http://                       changes.                                              application process for draft test method
                                                      www.regulations.gov, and insert the                                                                           CPSC–CH–C1001–09.4 (2017) on the
                                                                                                              B. Notice of Requirements
                                                      docket number CPSC–2017–0043, into                                                                            date the final NOR rule is published in
                                                      the ‘‘Search’’ box, and follow the                         Section 14(a) of the CPSA requires                 the Federal Register. Laboratories that
                                                      prompts.                                                that products subject to a consumer                   seek CPSC acceptance to the revised
                                                                                                              product safety rule under the CPSA, or                prohibitions for children’s toys and
                                                      FOR FURTHER INFORMATION CONTACT:                        to a similar rule, ban, standard, or                  child care articles in 16 CFR part 1307
                                                      Scott R. Heh, Project Manager,                          regulation under any other act enforced               would be required to update their
                                                      Directorate for Laboratory Sciences,                    by the Commission, be certified as                    accreditation scope. To be CPSC-
                                                      Consumer Product Safety Commission,                     complying with all applicable CPSC                    accepted, a laboratory’s scope of
                                                      5 Research Place, Rockville, MD 20850;                  requirements. 15 U.S.C. 2063(a). Such                 accreditation must include the reference
                                                      telephone: 301–504–7646; email: sheh@                   certification must be based on a test of              to draft CPSC–CH–C1001–09.4 (2017).
                                                      cpsc.gov.                                               each product, or on a reasonable testing              Laboratories that are currently CPSC-
                                                      SUPPLEMENTARY INFORMATION:                              program or, for children’s products, on               accepted to CPSC–CH–C1001–09.3
                                                      A. Background                                           tests of a sufficient number of samples               (2010) would be instructed to update
                                                                                                              by a third party conformity assessment                their accreditation scope to include
                                                         Section 108 of the Consumer Product                  body accredited by the Commission to                  draft CPSC–CH–C1001–09.4 (2017) as
                                                      Safety Improvement Act of 2008                          test according to the applicable                      soon as possible, and submit their
                                                      (CPSIA) established requirements                        requirements. The Commission’s                        application for CPSC acceptance.
                                                      concerning concentration limits for                     phthalates rule is considered a                       Laboratories that were not previously
                                                      specified phthalates in children’s toys                 ‘‘consumer product safety standard.’’ 15              CPSC-accepted to CPSC–CH–C1001–
                                                      and child care articles. In this same                   U.S.C. 2063c(f). Thus, products subject               09.3 (2010) would be instructed to work
                                                      issue of the Federal Register, the                      to the phthalates rule are subject to the             with their accreditation bodies to
                                                      Commission is publishing a final rule                   testing and certification requirements of             include ‘‘CPSC–CH–C1001–09.4 (2017)’’
                                                      that changes some of the statutory                      section 14 of the CPSA.                               in their scope documents.
                                                      phthalate restrictions currently in place                  Because children’s toys and child care                CPSC would accept testing results to
                                                      pursuant to section 108(b)(3) of the                    articles are children’s products, samples             the new phthalates prohibitions in 16
                                                      CPSIA. 15 U.S.C. 2063c(a). The                          of these products must be tested by a                 CFR part 1307 from laboratories that are
                                                      Commission’s phthalates rule makes                      third party conformity assessment body                CPSC-accepted to CPSC–CH–C1001–
                                                      permanent the interim prohibition on                    whose accreditation has been accepted                 09.3 (2010) for two years from the date
                                                      children’s toys that can be placed in a                 by the Commission. These products also                of publication of the final rule NOR in
                                                      child’s mouth and child care articles                   must comply with all other applicable                 the Federal Register. This should allow
                                                      that contain concentrations of more than                CPSC requirements, such as the lead                   adequate time for laboratories to work
                                                      0.1 percent of diisononyl phthalate                     content requirements of section 101 of                with their accreditation bodies to make
                                                      (DINP). The phthalates rule extends this                the CPSIA, the requirements of the toy                official updates to their accreditation
                                                      prohibition to cover all children’s toys                standard, 16 CFR part 1250, and the                   scope document to include the revised
                                                      and child care articles containing                      tracking label requirement in section                 CPSC method ‘‘CPSC–CH–C1001–09.4
                                                      concentrations of more than 0.1 percent                 14(a)(5) of the CPSA.                                 (2017)’’ and submit applications to the
                                                      of DINP. The phthalates rule also lifts                    In accordance with section                         CPSC. Two years after the date the final
                                                      the interim prohibitions on children’s                  14(a)(3)(B)(vi) of the CPSIA, the                     rule NOR publishes in the Federal
                                                      toys that can be placed in a child’s                    Commission has previously published                   Register, the CPSC will no longer accept
                                                      mouth and child care articles that                      two NORs for accreditation of third                   laboratory applications that reference
                                                      contain concentrations of more than 0.1                 party conformity assessment bodies for                CPSC–CH–C1001–09.3 (2010), and any
                                                      percent of di-n-octyl phthalate (DNOP)                  testing children’s toys and child care                application to CPSC must reference
                                                      or diisodecyl phthalate (DIDP). In                      articles under section 108 of the CPSIA
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                                                                                                                                                                    ‘‘CPSC–CH–C1001–09.4 (2017).’’
                                                      addition, the phthalates rule prohibits                 (76 FR 49286 (Aug. 10, 2011), 78 FR
                                                      children’s toys and child care articles                 15836 (March 12, 2013)).                              C. Description of the Proposed Rule
                                                      that contain concentrations of more than                   If the Commission finalizes the NOR                  The proposed rule would amend 16
                                                      0.1 percent of diisobutyl phthalate                     as proposed, the following process                    CFR 1112(b)(31), (31)(i) and (c)(3)(i) to
                                                      (DIBP), Di-n-pentyl phthalate (DPENP),                  would be used during the transition                   update the references to reflect the
                                                      di-n-hexyl phthalate (DHEXP), and                       period from test method CPSC–CH–                      promulgation of 16 CFR part 1307 and
                                                      dicyclohexyl phthalate (DCHP). The                      C1001–09.3 (2010) to a revised version                draft CPSC test method CPSC–CH–
                                                      permanent prohibitions on children’s                    of the method, currently titled, draft test           C1001–09.4 (2017). The draft test
                                                      toys and child care articles that contain               method CPSC–CH–C1001–09.4 (2017).                     method would provide detailed


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                                                                              Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules                                             49769

                                                      information on testing that will be used                regulatory flexibility analysis for any               F. Environmental Considerations
                                                      by the CPSC testing laboratory for the                  rule subject to notice and comment
                                                      analysis of phthalate content in                        rulemaking requirements under the                       The Commission’s regulations
                                                      children’s toys and child care articles.                APA, or any other statute, unless the                 provide a categorical exclusion for the
                                                      CPSC staff has determined that using an                 agency certifies that the rulemaking will             Commission’s rules from any
                                                      appropriate combination of the methods                  not have a significant economic impact                requirement to prepare an
                                                      of extraction and analysis presented in                 on a substantial number of small                      environmental assessment or an
                                                      the test method is sufficient to                        entities. 5 U.S.C. 603 and 605. Small                 environmental impact statement
                                                      determine the concentration of the                      entities include small businesses, small              because they ‘‘have little or no potential
                                                      regulated phthalates in most children’s                 organizations, and small governmental                 for affecting the human environment.’’
                                                      toys and child care articles. The general               jurisdictions.                                        16 CFR 1021.5(c)(2). This rule falls
                                                      approach is to dissolve the sample                         The impact of the proposed rule on                 within the categorical exclusion, so no
                                                      completely in tetrahydrofuran,                          small testing laboratories would be                   environmental assessment or
                                                      precipitate any PVC polymer with a                      minimal. The only laboratories that                   environmental impact statement is
                                                      second solvent, then analyze by Gas                     would be impacted are those that offer                required.
                                                      Chromatography-Mass Spectrometry                        to test children’s toys and child care                List of Subjects in 16 CFR Part 1112
                                                      (GC–MS). The draft test method                          articles for prohibited phthalates. These
                                                      provides definitions, a list of equipment               laboratories are already accredited by                  Administrative practice and
                                                      and supplies needed for testing,                        one or more accreditation bodies that                 procedure, Audit, Consumer protection,
                                                      procedures to measure phthalate                         are signatories to the International                  Incorporation by reference, Reporting
                                                      concentration, instructions for sample                  Laboratory Accreditation Cooperation—                 and recordkeeping requirements, Third
                                                      preparation, and descriptions of the                    Mutual Recognition Arrangement                        party conformity assessment body.
                                                      phthalate extraction method and                         (ILAC–MRA) and have had their
                                                      instrument parameters. The draft test                   accreditations accepted by the                          For the reasons discussed in the
                                                      method is available at Tab A of the                     Commission. These laboratories would                  preamble, the Commission proposes to
                                                      CPSC staff’s briefing package available                 have to revise their procedures for                   amend Title 16 CFR chapter II, as
                                                      on CPSC’s Web site at: https://                         testing for phthalate content to be                   follows:
                                                      www.cpsc.gov/s3fs-public/                               consistent with the revised phthalate
                                                                                                                                                                    PART 1112—REQUIREMENTS
                                                      Notice%20of%                                            test method (CPSC–CH–C1001–09.4)
                                                                                                                                                                    PERTAINING TO THIRD PARTY
                                                      20Proposed%20Rulemaking%20for                           which would replace the current
                                                                                                                                                                    CONFORMITY ASSESSMENT BODIES
                                                      %20NOR%20for%20Phthalates%20-%                          phthalate test method (CPSC–CH–
                                                      20September%2013%202017.pdf?pH5_                        C1001–09.3) if the proposed NOR is
                                                                                                              finalized. Staff expects that the impact              ■ 1. The authority citation for part 1112
                                                      n4seuAb0.USRYqPfsnmLuTKC8F_2.
                                                                                                              of revising testing procedures will be                continues to read as follows:
                                                      Draft CPSC test method CPSC–CH–
                                                      C1001–09.4 (2017) has been updated to                   low for qualified laboratories because                  Authority: 15 U.S.C. 2063; Pub. L. 110–
                                                      reflect the list of phthalates prohibited               the same sample preparation, extraction               314, section 3, 122 Stat. 3016, 3017 (2008).
                                                      in children’s toys and child care articles              methods, and equipment is used for
                                                                                                                                                                    ■ 2. Amend § 1112.15 by:
                                                      in 16 CFR part 1307 ((di(2-ethylhexyl)                  both methods. Moreover, the additional
                                                      phthalate (DEHP), dibutyl phthalate                     phthalates included in draft CPSC–CH–                 ■ a. Revising the introductory text to
                                                      (DBP), butyl benzyl phthalate (BBP), di-                C1001–09.4 can be isolated at unique                  paragraph (b)(31);
                                                      n-octyl phthalate (DNOP) diisobutyl                     elution times by gas chromatography                   ■ b. Revising paragraph (b)(31)(i); and
                                                      phthalate (DIBP), di-n-pentyl phthalate                 and, therefore, the analysis should not               ■ c. Revising paragraph (c)(3)(i).
                                                      (DPENP), di-n-hexyl phthalate (DHEXP),                  be a burden for those qualified to
                                                      or dicyclohexyl phthalate (DCHP)). The                  perform such testing.                                   The revisions read as follows:
                                                      draft test method CPSC–CH–C1001–09.4                       Additionally, within two years of the              § 1112.15 When can a third party
                                                      (2017) is substantially the same as the                 publication of the final NOR rule,                    conformity assessment body apply for
                                                      current testing procedure. The                          laboratories would need to update their               CPSC acceptance for a particular CPSC rule
                                                      Commission encourages comments on                       scope accreditation documents to                      or test method?
                                                      draft CPSC test method CPSC–CH–                         include the revised phthalate test                    *     *     *    *     *
                                                      C1001–09.4 (2017). We note that the                     method (CPSC–CH–C1001–09.4). Staff
                                                                                                              expects that the burden of this                         (b) * * *
                                                      draft test method could change in the
                                                      final rule.                                             requirement will also be low because                    (31) 16 CFR part 1307, Prohibition of
                                                                                                              testing laboratories typically must                   Children’s Toys and Child Care Articles
                                                      D. Effective Date                                       undergo a reassessment every two years                Containing Specified Phthalates. For its
                                                         The APA generally requires that a                    in order to maintain their accreditations.            accreditation to be accepted by the
                                                      substantive rule must be published not                  Updating the accreditation scope                      Commission to test for phthalates in
                                                      less than 30 days before its effective                  documents to include the revised                      children’s toys and child care articles, a
                                                      date. 5 U.S.C. 553(d)(1). Because the                   phthalate test method is a minor change               third party conformity assessment body
                                                      proposed rule would allow testing to                    and should result in little or no                     must have one or more of the following
                                                                                                              additional cost to a testing laboratory if            test methods referenced in its statement
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                                                      continue under the existing testing
                                                      method by testing laboratories that meet                completed during the periodic                         of scope:
                                                      certain criteria for a period of up to two              reassessment, which the 2-year window                   (i) CPSC Test Method CPSC–CH–
                                                      years after the publication of a final                  would allow testing laboratories to do.               1001–09.4, ‘‘Standard Operating
                                                      rule, the Commission proposes a 30 day                     After considering the economic                     Procedure for Determination of
                                                      effective date for the final rule.                      impacts of this proposed rule on small                Phthalates;
                                                                                                              entities, the Commission certifies that
                                                      E. Regulatory Flexibility Act                                                                                 *     *     *    *     *
                                                                                                              the proposed rule would not have a
                                                        The Regulatory Flexibility Act (RFA)                  significant economic impact on a                        (c) * * *
                                                      requires an agency to prepare a                         substantial number of small entities.                   (3) * * *


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                                                      49770                    Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules

                                                        (i) CPSC–CH–C1001–9.4, ‘‘Standard                       • Mail: Docket Management Facility,                 FMCSA recommends that you include
                                                      Operating Procedure for Determination                   U.S. Department of Transportation, 1200               your name and a mailing address, an
                                                      of Phthalates’’, September 1, 2017.                     New Jersey Avenue SE., West Building,                 email address, or a phone number in the
                                                      *     *    *      *    *                                Ground Floor, Room W12–140,                           body of your document so the Agency
                                                                                                              Washington, DC 20590–0001.                            can contact you if it has questions
                                                      Alberta E. Mills,                                         • Hand Delivery or Courier: West                    regarding your submission.
                                                      Acting Secretary, U.S. Consumer Product                 Building, Ground Floor, Room W12–
                                                      Safety Commission.                                                                                               To submit your comments online, go
                                                                                                              140, 1200 New Jersey Avenue SE.,
                                                      [FR Doc. 2017–23266 Filed 10–26–17; 8:45 am]                                                                  to www.regulations.gov and put the
                                                                                                              between 9 a.m. and 5 p.m., Monday
                                                                                                                                                                    docket number, ‘‘FMCSA–2017–0296’’
                                                      BILLING CODE 6355–01–P                                  through Friday, except Federal holidays.
                                                                                                                                                                    in the ‘‘Keyword’’ box, and click
                                                                                                                • Fax: 1–202–493–2251.
                                                                                                                 • Each submission must include the                 ‘‘Search.’’ When the new screen
                                                      DEPARTMENT OF TRANSPORTATION                            Agency name and the docket number for                 appears, click on ‘‘Comment Now!’’
                                                                                                              this notice. Note that DOT posts all                  button and type your comment into the
                                                      Federal Motor Carrier Safety                            comments received without change to                   text box in the following screen. Choose
                                                      Administration                                          www.regulations.gov, including any                    whether you are submitting your
                                                                                                              personal information included in a                    comment as an individual or on behalf
                                                      49 CFR Part 395                                         comment. Please see the Privacy Act                   of a third party and then submit. If you
                                                                                                              heading below.                                        submit your comments by mail or hand
                                                      [Docket No. FMCSA–2017–0296]
                                                                                                                 Docket: For access to the docket to                delivery, submit them in an unbound
                                                      Hours of Service of Drivers:                            read background documents or                          format, no larger than 81⁄2 by 11 inches,
                                                      Application for Exemption; Western                      comments, go to www.regulations.gov at                suitable for copying and electronic
                                                      Equipment Dealers Association                           any time or visit Room W12–140 on the                 filing. If you submit comments by mail
                                                      (WEDA)                                                  ground level of the West Building, 1200               and would like to know that they
                                                                                                              New Jersey Avenue SE., Washington,                    reached the facility, please enclose a
                                                      AGENCY:  Federal Motor Carrier Safety                   DC, between 9 a.m. and 5 p.m., ET,                    stamped, self-addressed postcard or
                                                      Administration (FMCSA), DOT.                            Monday through Friday, except Federal                 envelope. FMCSA will consider all
                                                      ACTION: Application for exemption;                      holidays. The on-line FDMS is available               comments and material received during
                                                      request for comments.                                   24 hours each day, 365 days each year.                the comment period and may grant or
                                                                                                                 Privacy Act: In accordance with 5                  not grant this application based on your
                                                      SUMMARY:   FMCSA announces that the                     U.S.C. 553(c), DOT solicits comments                  comments.
                                                      Western Equipment Dealers Association                   from the public to better inform its
                                                      (WEDA) has requested an exemption on                                                                          II. Legal Basis
                                                                                                              rulemaking process. DOT posts these
                                                      behalf of several other organizations and               comments, without edit, including any
                                                      their membership from the requirement                                                                            FMCSA has authority under 49 U.S.C.
                                                                                                              personal information the commenter                    31136(e) and 31315 to grant exemptions
                                                      that no later than December 18, 2017, a                 provides, to www.regulations.gov, as
                                                      motor carrier require each of its drivers                                                                     from certain parts of the Federal Motor
                                                                                                              described in the system of records                    Carrier Safety Regulations (FMCSRs).
                                                      to use an electronic logging device                     notice (DOT/ALL–14 FDMS), which can
                                                      (ELD) to record the driver’s hours-of-                                                                        FMCSA must publish a notice of each
                                                                                                              be reviewed at www.dot.gov/privacy.                   exemption request in the Federal
                                                      service (HOS). WEDA states that
                                                                                                              FOR FURTHER INFORMATION CONTACT: For                  Register (49 CFR 381.315(a)). The
                                                      equipment dealer operations in
                                                      agriculture constitute unique                           information concerning this notice,                   Agency must provide the public an
                                                      circumstances that warrant the                          contact Mr. Tom Yager, Chief, FMCSA                   opportunity to inspect the information
                                                      requested exemption, and not granting it                Driver and Carrier Operations Division;               relevant to the application, including
                                                      will pose an undue burden on                            Office of Carrier, Driver and Vehicle                 any safety analyses that have been
                                                      equipment dealers and their customers                   Safety Standards; Telephone: 614–942–                 conducted. The Agency must also
                                                      without any measurable safety benefit.                  6477. Email: MCPSD@dot.gov. If you                    provide an opportunity for public
                                                      In its application, WEDA seeks a five-                  have questions on viewing or submitting               comment on the request.
                                                      year, renewable exemption from the                      material to the docket, contact Docket
                                                                                                              Services, telephone (202) 366–9826.                      The Agency reviews safety analyses
                                                      ELD requirements which, the                                                                                   and public comments submitted, and
                                                      organization states, if granted will                    SUPPLEMENTARY INFORMATION:
                                                                                                                                                                    determines whether granting the
                                                      achieve a level of safety equivalent to,                I. Public Participation and Request for               exemption would likely achieve a level
                                                      or greater than, the level that would be                Comments                                              of safety equivalent to, or greater than,
                                                      achieved absent the proposed                                                                                  the level that would be achieved by the
                                                      exemption. FMCSA requests public                          FMCSA encourages you to participate
                                                                                                              by submitting comments and related                    current regulation (49 CFR 381.305).
                                                      comment on WEDA’s application for                                                                             The decision of the Agency must be
                                                      exemption.                                              materials.
                                                                                                                                                                    published in the Federal Register (49
                                                      DATES:  Comments must be received on                    Submitting Comments                                   CFR 381.315(b)) with the reasons for
                                                      or before November 27, 2017.                              If you submit a comment, please                     denying or granting the application and,
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                                                      ADDRESSES: You may submit comments                      include the docket number for this                    if granted, the name of the person or
                                                      identified by Federal Docket                            notice (FMCSA–2017–0296), indicate                    class of persons receiving the
                                                      Management System (FDMS) Number                         the specific section of this document to              exemption, and the regulatory provision
                                                      FMCSA–2017–0296 by any of the                           which the comment applies, and                        from which the exemption is granted.
                                                      following methods:                                      provide a reason for suggestions or                   The notice must also specify the
                                                        • Federal eRulemaking Portal:                         recommendations. You may submit                       effective period and explain the terms
                                                      www.regulations.gov. See the Public                     your comments and material online or                  and conditions of the exemption. The
                                                      Participation and Request for Comments                  by fax, mail, or hand delivery, but                   exemption may be renewed (49 CFR
                                                      section below for further information.                  please use only one of these means.                   381.300(b)).


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Document Created: 2017-10-27 02:06:12
Document Modified: 2017-10-27 02:06:12
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking.
DatesSubmit comments by January 10, 2018.
ContactScott R. Heh, Project Manager, Directorate for Laboratory Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-504- 7646; email: [email protected]
FR Citation82 FR 49767 
CFR AssociatedAdministrative Practice and Procedure; Audit; Consumer Protection; Incorporation by Reference; Reporting and Recordkeeping Requirements and Third Party Conformity Assessment Body

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