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)

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, 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.

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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