[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Rules and Regulations]
[Pages 4578-4580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01452]


=======================================================================
-----------------------------------------------------------------------

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: Final rule; notice of requirements.

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

SUMMARY: This final rule updates the notice of requirements (NOR) for 
the accreditation of third party laboratories to assess conformity with 
the prohibitions of children's toys and child care articles containing 
specified phthalates. The NOR provides the criteria and process for 
Commission acceptance of accreditation under the Consumer Product 
Safety Act (CPSA). This rule makes the NOR consistent with the 
regulated phthalates in children's toys and child care articles in the 
phthalates final rule published in the Federal Register on October 27, 
2017.

DATES: This rule is effective on April 25, 2018. The incorporation by 
reference of the publication listed in this rule is approved by the 
Director of the Federal Register, as of April 25, 2018.

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 
accordance with section 108 of the CPSIA, on October 27, 2017, the 
Commission published a phthalates final rule (phtahalates rule) in the 
Federal Register (82 FR 49938). That final rule made 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 
extended 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 lifted 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 
prohibited 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 were unchanged by 
the phthalates rule.
    On October 27, 2017, in the same issue of the Federal Register, the 
Commission published a notice of proposed rulemaking (NPR) to update 
the existing NOR in part 1112 for prohibitions of children's toys and 
child care articles containing specified phthalates. As explained 
further below, NORs provide the criteria and process for Commission 
acceptance of accreditation of third party testing laboratories that 
test products' conformance to CPSC requirements. The Commission 
previously issued an NOR for the statutory phthalate provisions, 76 FR 
49286 (August 10, 2011). The October 27, 2017 NPR proposed to amend 
part 1112 to reflect the phthalates prohibited in children's toys and 
child care articles in the phthalates rule. Because the phthalates rule 
modified the statutorily prohibited phthalates in children's toys and 
child care articles listed in section 108 of the CPSIA (as stated in 
Sec.  1307.3), this final rule amends the existing requirements for the 
prohibitions of children's toys and child care articles containing 
specified phthalates so that part 1112 reflects 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. Products that are subject 
to a children's product safety rule must be certified based on tests of 
a sufficient

[[Page 4579]]

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 
``children's product safety rule.'' 15 U.S.C. 2063(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)).
    As described in the NPR, the Commission will use the following 
process during the transition period from test method CPSC-CH-C1001-
09.3 (2010) to a revised version of the method, test method CPSC-CH-
C1001-09.4 (2018). CPSC will 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 (2018).
    The CPSC will open the laboratory application process for test 
method CPSC-CH-C1001-09.4 (2018) on the date this final 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 will be required to update their 
accreditation scope. To be CPSC-accepted, a laboratory's scope of 
accreditation must include the reference to CPSC-CH-C1001-09.4 (2018). 
Laboratories that are currently CPSC-accepted to CPSC-CH-C1001-09.3 
(2010) are instructed to update their accreditation scope to include 
CPSC-CH-C1001-09.4 (2018) 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) are instructed to work with 
their accreditation bodies to include ``CPSC-CH-C1001-09.4 (2018)'' in 
their scope documents.
    CPSC will 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 this 
final rule 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 (2018)'' and submit applications to 
the CPSC. On February 3, 2020, 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 (2018).''

C. Comments on the NPR

    We received four comments on the NPR. Three comments addressed the 
DRAFT CPSC procedure CPSC-CH-C1001-09.4 (2017) that was published with 
the October 2017 NPR briefing package. The first comment requested 
clarification of the final list of prohibited phthalates. The second 
comment highlighted ``that dissolved PVC-samples can be precipitated by 
adding hexane. The phthalates remain in solution. The centrifuged 
solution can then be measured in the GC.'' The third comment came from 
a testing laboratory representative who recommended a few changes to 
add clarity and more specificity to the CPSC procedure. The fourth 
comment was outside the scope of the rule.
    Staff made editorial clarifications to the DRAFT CPSC procedure 
based on the comments. Staff revised the test procedure to clarify the 
final list of eight prohibited phthalates. Also, staff made several 
additions to the test equipment and supplies section of the test method 
reflected in test method CPSC-CH-C1001-09.4 (2018) in response to 
comment.
    Staff did not accept some of the commenters' suggested changes to 
the test method. The revised test method does not add a temperature 
specification to the sonication reference in the extraction steps 
because the extraction is not heat dependent. Additionally, the revised 
test method does not include suggested additional elements to the Table 
1 Conditions for Gas Chromatography-Mass Spectrometry (GC-MS). Staff 
did not make changes to Table 1, as well as other recommended quality 
assurance changes to the analysis section of the test method, in order 
to allow accredited laboratories flexibility in setting up their 
internal standard operating and quality assurance procedures. Adding 
the suggested requirements to Table 1 might have forced accredited 
laboratories to alter already suitable quality assurance programs, thus 
reducing flexibility. The comment relating to use of hexane for PVC 
samples did not warrant a change to the test method because the test 
method already permits the use of hexane.

D. Description of the Rule

    The final rule amends 16 CFR 1112.15(b)(31) introductory text, 
(b)(31)(i), and (c)(3)(i) to update the references to reflect the 
promulgation of 16 CFR part 1307 and revised CPSC test method CPSC-CH-
C1001-09.4 (2018). CPSC test method CPSC-CH-C1001-09.4 (2018), has, 
among other things, been updated to reflect the list of phthalates 
prohibited in children's toys and child care articles in 16 CFR part 
1307 (DEHP, DBP, BBP, DNOP, DIBP, DPENP, DHEXP, or DCHP). CPSC test 
method CPSC-CH-C1001-09.4 (2018) provides detailed information on the 
test methods that will be used by the CPSC testing laboratory for the 
analysis of phthalate content in children's toys and child care 
articles covered by the standard set forth in section 108 of the CPSIA 
and 16 CFR part 1307. The test method provides detailed information 
regarding equipment and supplies, the procedure for the measurement of 
phthalate concentration, sample preparation, the phthalate extraction 
method, and instrument parameters. The test method CPSC-CH-C1001-09.4 
(2018) is substantially the same as the current testing procedure.

E. Incorporation by Reference

    The Office of the Federal Register (OFR) has regulations concerning 
incorporation by reference. 1 CFR part 51. Under these regulations, 
agencies must discuss, in the preamble to the final rule, ways that the 
materials the agency incorporates by reference are reasonably available 
to interested persons and how interested parties can obtain the 
materials. In addition, the preamble to the final rule must summarize 
the material. 1 CFR 51.5(b).
    In accordance with the OFR's requirements, section D of this 
preamble summarizes CPSC test method CPSC-CH-C1001-09.4 (2018) that the 
Commission incorporates by reference

[[Page 4580]]

into 16 CFR part 1112. The test method is reasonably available to 
interested parties, and interested parties may obtain a copy of the 
test method from CPSC National Product Testing and Evaluation Center, 5 
Research Place, Rockville, MD 20850; www.cpsc.gov. The test method is 
also available on the CPSC website. https://cpsc.gov/Business-Manufacturing/Testing-Certification/Lab-Accreditation/Test-Methods/. A 
copy of the test method can also be inspected at CPSC's Office of the 
Secretary, U.S. Consumer Product Safety Commission, Room 820, 4330 
East-West Highway, Bethesda, MD 20814, telephone 301-504-7923.

F. 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). The NPR proposed a 30-day effective date because the rule 
allows 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. However, to avoid possible 
confusion if the effective date for this rule differed from the 
effective date for the underlying phthalates rule, we are setting the 
effective date for the rule on April 25, 2018, the same date the 
phthalates rule takes effect. This is consistent with past practice 
setting the effective date for NORs for durable nursery products under 
section 104 of the CPSIA and updates to the mandatory toy standard ASTM 
F963 on the same date the underlying rule takes effect.

G. 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 Commission certified, in the NPR, that the rule would not have 
a significant impact on a substantial number of small entities because 
the revised testing method is substantially the same as the method that 
laboratories are already using, qualified testing laboratories should 
be able to adopt the new method without difficulty, and the 2-year 
window allowed to amend the accreditation scope documents would allow 
testing laboratories to time the amendments with their periodic 
reassessments by their accreditation bodies, which should result in 
minimal (if any) additional cost. The Commission did not receive any 
public comments that addressed the potential impact on small entities, 
nor has the Commission staff become aware of any new information that 
would change its previous determination regarding the impact on small 
entities.

H. 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 amends 
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-C1001-09.4, ``Standard Operating 
Procedure for Determination of Phthalates'';
* * * * *
    (c) * * *
    (3) * * *
    (i) CPSC-CH-C1001-9.4, ``Standard Operating Procedure for 
Determination of Phthalates'', January 17, 2018;
* * * * *

Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2018-01452 Filed 1-31-18; 8:45 am]
 BILLING CODE 6355-01-P