[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3583-3585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01451]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2016-0017]

16 CFR Part 1308


Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates: Revision of Determinations Regarding Certain 
Plastics

AGENCY: Consumer Product Safety Commission.

ACTION: Direct final rule.

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SUMMARY: On August 30, 2017, the Commission issued a final rule 
determining that certain plastics and additives would not contain the 
phthalates that the Consumer Product Safety Improvement Act of 2008 
(CPSIA) prohibits from use in children's toys and child care articles. 
Subsequently, the Commission issued a final rule that removes some 
phthalates from the statutory prohibition and adds others. This direct 
final rule revises the determinations rule to cover the phthalates that 
the phthalates final rule prohibits from use in children's toys and 
child care articles.

DATES: The rule is effective on April 25, 2018, unless we receive 
significant adverse comment by February 26, 2018. If we receive timely 
significant adverse comment, we will publish notification in the 
Federal Register, withdrawing this direct final rule before its 
effective date.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2016-
0017, by any of the following methods:
    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments. To ensure timely processing of 
comments, the Commission is no longer accepting comments submitted by 
electronic mail (email), except through www.regulations.gov.
    Submit written submissions in the following way:
    Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions), preferably in five copies, 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 docket number for this document. 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 
electronically. Such information should be submitted in writing.

FOR FURTHER INFORMATION CONTACT: For information, contact: John W. 
Boja, Lead Compliance Officer, Office of Compliance and Field 
Operations, Consumer Product Safety Commission, 4330 East-West Highway, 
Bethesda, MD 20814-4408; telephone: 301-504-7300; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

Statutory Prohibitions

    Section 108 of the CPSIA established permanent and interim 
prohibitions that prohibited the use of certain phthalates in 
children's toys and child care articles. 15 U.S.C. 2057c(a) and (b). 
The

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CPSIA also directed the Commission to issue a rule deciding whether to 
make the interim prohibitions permanent and whether to prohibit other 
children's products containing any phthalates. Id. 2057c(b)(3). In the 
following discussion, we refer to rulemaking under section 108 of the 
CPSIA as the phthalates rule or rulemaking.

Third Party Testing and Burden Reduction

    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). For children's products, certification must be based on 
testing conducted by a CPSC-accepted third party conformity assessment 
body. Id. Public Law 112-28 (August 12, 2011) amended the CPSA and 
directed the CPSC to seek comment on ``opportunities to reduce the cost 
of third party testing requirements consistent with assuring compliance 
with any applicable consumer product safety rule, ban, standard, or 
regulation.'' Public Law 112-28 also authorized the Commission to issue 
new or revised third party testing regulations if the Commission 
determines ``that such regulations will reduce third party testing 
costs consistent with assuring compliance with the applicable consumer 
product safety rules, bans, standards, and regulations.'' 15 U.S.C. 
2063(d)(3)(B).
    The Commission may issue determinations that specific materials do 
not contain prohibited substances such as lead or phthalates. Based on 
such a determination, the specified material would not require third 
party testing for compliance with the applicable mandatory prohibition.
    The determinations only relieve the manufacturer's obligation to 
have the specific materials tested by a CPSC-accepted third party 
conformity assessment body. Children's products must still comply with 
the applicable substantive requirements, regardless of any relief from 
third party testing requirements. Additionally, the manufacturer must 
issue a certificate stating that the product complies with CPSC 
requirements.

Determinations Rule

    On August 30, 2017, the Commission published a final rule 
determining that specified plastics and additives would not contain 
materials subject to the prohibition of children's toys and child care 
articles containing specified phthalates. 82 FR 41163. The rule created 
a new part 1308 for ``Prohibition of Children's Toys and Child Care 
Articles Containing Specified Phthalates: Determinations Regarding 
Certain Plastics.'' The rule determined that the specified plastics and 
accompanying additives do not contain the statutorily prohibited 
phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) in concentrations above 
0.1 percent, and thus, are not required to be third party tested to 
assure compliance with section 108 of the CPSIA. At the time the 
Commission issued the determinations rule, the Commission had issued a 
proposed rule in the phthalates rulemaking, but had not yet promulgated 
a final rule in that proceeding. The preambles of both the NPR and 
final rule for the determinations noted that the research providing the 
basis for the determinations covering the six phthalates subject to the 
statutory prohibition, applied as well to the additional four 
phthalates the Commission had proposed prohibiting in children's toys 
and child care articles in the phthalates NPR. In the preamble to the 
final determinations rule, the Commission indicated that when the 
Commission published the final phthalates rule, the Commission would 
amend the determinations rule to reflect the phthalates regulated in 
the phthalates final rule. 82 FR 41163, at 41164.

Phthalates Final Rule

    On October 27, 2017, the Commission published the final phthalates 
rule in the Federal Register. 82 FR 49938. The phthalates rule, which 
is codified at 16 CFR part 1307, makes permanent the interim statutory 
prohibition on diisononyl phthalate (DINP) and expands that restriction 
to prohibit all children's toys and child care articles that contain 
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). Additionally, the phthalates rule also 
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 
dicyclohexly 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. The phthalates rule takes effect on April 25, 2018.

B. Revisions to 16 CFR Part 1308

    This direct final rule amends 16 CFR 1308.1 to cover the phthalates 
listed in the phthalates final rule discussed in section A of the 
preamble. This action will bring the determinations into alignment with 
the phthalates final rule so that firms will be able to use the 
determinations to reduce testing burdens related to the final 
phthalates rule as they have with the statutory prohibitions. The 
amendment does not make any other changes to the determinations rule.

C. Direct Final Rule Process

    The Commission is issuing this rule as a direct final rule. The 
Administrative Procedure Act (APA) generally requires notice and 
comment rulemaking. 5 U.S.C. 553. The direct final rule process is an 
appropriate way to satisfy this requirement in certain circumstances. 
In Recommendation 95-4, the Administrative Conference of the United 
States (ACUS) endorsed direct final rulemaking as an appropriate 
procedure to expedite promulgation of rules that are noncontroversial 
and that are not expected to generate significant adverse comment. See 
60 FR 43108 (August 18, 1995). The Commission concludes that a direct 
final rule is appropriate here. The Commission is taking the limited 
action of amending the determinations rule at 16 CFR part 1308 to 
reflect the phthalates that are restricted under the Commission's 
phthalates rule. The previous determinations rule explained that the 
reports supporting the determinations regarding the phthalates that are 
covered by the statutory prohibitions in section 108 of the CPSIA also 
apply to the phthalates covered by the Commission's phthalates rule. We 
also note that this determination rule is separate from the 
Commission's phthalates rulemaking which was concluded with the 
Commission's issuance of a final rule on October 27, 2017. Because this 
document merely updates the regulated phthalates in the determinations 
rule, the Commission believes this rulemaking is a non-controversial 
matter which is not likely to generate comments. Therefore, the 
Commission concludes that the direct final rule process is appropriate.
    Unless we receive a significant adverse comment within 30 days, the 
rule will take effect on April 25, 2018. In accordance with ACUS's

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recommendation, the Commission considers a significant adverse comment 
to be one where the commenter explains why revising the list of 
regulated phthalates would be inappropriate. We note that comments on 
either the underlying determinations or phthalates final rules are not 
considered significant adverse comments because the only change this 
rule makes is to revise the list of covered phthalates.
    Should the Commission receive significant adverse comment, the 
Commission would withdraw this direct final rule. Depending on the 
comments and other circumstances, the Commission may then incorporate 
the adverse comment into a subsequent direct final rule or publish a 
notice of proposed rulemaking, providing an opportunity for public 
comment.

D. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires that 
agencies review proposed and final rules for their potential economic 
impact on small entities, including small businesses, and prepare 
regulatory flexibility analyses. 5 U.S.C. 603 and 604. CPSC conducted a 
final regulatory flexibility analysis (FRFA) for the determinations 
rule that the Commission issued in August 2017. The FRFA found that 
``the impact of the determinations on small businesses would be to 
reduce the burden of third party testing for phthalate content and 
would be expected to be entirely beneficial.'' 82 FR 41171. As 
explained above, this direct final rule takes the limited action of 
revising the list of covered phthalates to bring the determinations 
rule into line with the phthalates rule so that companies will be able 
to use the determinations to reduce third party testing under the 
phthalates rule as they have under the statutory prohibitions.

E. Effective Date

    As discussed in section C of this preamble, this is a direct final 
rule. Unless we receive a significant adverse comment within 30 days, 
the rule will take effect on April 25, 2018.

List of Subjects in 16 CFR Part 1308

    Business and industry, Consumer protection, Imports, Infants and 
children, Product testing and certification, Toys.

    Accordingly, the Commission amends 16 CFR part 1308 as follows:

PART 1308--PROHIBITION OF CHILDREN'S TOYS AND CHILD CARE ARTICLES 
CONTAINING SPECIFIED PHTHALATES: DETERMINATIONS REGARDING CERTAIN 
PLASTICS

0
1. The authority citation for part 1308 continues to read as follows:

    Authority: Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 
2063(d)(3)(B).

0
2. Revise Sec.  1308.1 to read as follows:


Sec.  1308.1  Prohibited children's toys and child care articles 
containing specified phthalates and testing requirements.

    Section 108(a) of the Consumer Product Safety Improvement Act of 
2008 (CPSIA) permanently prohibits any children's toy or child care 
article that contains concentrations of more than 0.1 percent of di-(2-
ethylhexl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl 
phthalate (BBP). In accordance with section 108(b)(3) of the CPSIA, 16 
CFR part 1307 prohibits any children's toy or child care article that 
contains concentrations of more than 0.1 percent of diisononyl 
phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate 
(DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexly phthalate (DCHP) 
is prohibited. Materials used in children's toys and child care 
articles subject to section 108(a) of the CPSIA and 16 CFR part 1307 
must comply with the third party testing requirements of section 
14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in 
Sec.  1308.2.

Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2018-01451 Filed 1-25-18; 8:45 am]
 BILLING CODE 6355-01-P