[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Rules and Regulations]
[Pages 16635-16636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06223]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1307

[Docket No. CPSC-2014-0033]


Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates

AGENCY: Consumer Product Safety Commission.

ACTION: Request for comments.

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SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is 
publishing this document following a Federal court opinion remanding 
the Commission's final phthalates rule to allow the Commission to 
address two procedural deficiencies found by the court. This document 
seeks public comment regarding the justification for the phthalates 
final rule and the staff's cost-benefit analysis for continuing the 
interim prohibition on DINP.

DATES: Written comments should be submitted by May 9, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2014-
0033, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov and as described below. The CPSC encourages you to 
submit electronic comments by using the Federal eRulemaking Portal, as 
described above.
    Mail/Hand Delivery/Courier Submissions: Submit comments by mail/
hand delivery/courier to: Division of the Secretariat, Consumer Product 
Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 
20814; telephone (301) 504-7479. Alternatively, as a temporary option 
during the COVID-19 pandemic, you can email such submissions to: [email protected].
    Instructions: All submissions received must include the agency name 
and docket number for this notice. CPSC may post all comments without 
change, including any personal identifiers, contact information, or 
other personal information provided, to: https://www.regulations.gov. 
Do not submit electronically confidential business information, trade 
secret information, or other sensitive or protected information that 
you do not want to be available to the public. If you wish to submit 
such information, please submit it according to the instructions for 
written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2014-0033, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Susan Proper, Directorate for Economic 
Analysis, Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone: (301) 504-7628; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 108(b)(3) of the Consumer Product Safety Improvement Act of 
2008 (CPSIA) required the Commission to promulgate a final rule 
addressing children's toys and child care articles containing certain 
phthalates not later than 180 days after the Commission received a 
final Chronic Hazard Advisory Panel (CHAP) report.\1\ The Commission 
was required to ``determine, based on such report, whether to continue 
in effect the [interim] prohibition'' on children's toys that can be 
placed in a child's mouth and child care articles ``in order to ensure 
a reasonable certainty of no harm to children, pregnant women, or other 
susceptible individuals with an adequate margin of safety.'' 15 U.S.C. 
2057c (b)(3)(A). Additionally, the Commission was required to 
``evaluate the findings and recommendations of the Chronic Hazard 
Advisory Panel and declare any children's product containing any 
phthalates to be a banned hazardous product under section 8 of the 
Consumer Product Safety Act (15 U.S.C. 2057), as the Commission 
determines necessary to protect the health of children.'' 15 U.S.C. 
2057c (b)(3)(B).
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    \1\ The Commission voted 4-0 to approve this notice.
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    On December 30, 2014, the Commission published a notice of proposed 
rulemaking (NPRM) in the Federal Register. 79 FR 78324. The Commission 
published a final rule on October 27, 2017, with an effective date of 
April 25, 2018. 82 FR 49938. The final rule was substantially the same 
as the proposed rule. The preambles of the NPRM and final rule provide 
more detailed discussions of the CHAP report and staff's technical 
analysis and findings in support of the rule.
    In December 2017, the Texas Association of Manufacturers and others 
petitioned the U.S. Court of Appeals for the Fifth Circuit for a review 
of the CPSC's final phthalates rule. In March 2021, the court remanded 
without vacating the phthalates final rule to the CPSC to address two 
procedural deficiencies found by the court. Tex. Ass'n of Mfrs. v. 
United States Consumer Prod. Safety Comm'n, 989 F.3d 368 (5th Cir. 
2021). As relevant here, the court held that the final rule had failed 
to: (1) Provide adequate notice and comment regarding a change in the 
primary justification from the proposed rule to the final rule; and (2) 
consider the costs and benefits of continuing the interim prohibition 
on DINP. This document is being published to address these two 
procedural deficiencies. We note that the court did not vacate the 
final rule, and thus the rule remains in effect.

II. Request for Comments

A. Phthalates Final Rule Justification

    The Fifth Circuit held that the phthalates final rule did not 
provide adequate notice and comment regarding a change in the primary 
justification between the proposed rule and the final rule. The court 
remanded the rule to allow CPSC to seek public comment on the 
justification for the final rule. The Commission's justification for 
the proposed rule was based on data demonstrating that 10 percent of 
pregnant women had a Hazard Index (HI) greater than one, which exceeded 
the acceptable risk, and that the average

[[Page 16636]]

HI was five at the 95th percentile. See 79 FR 78328-32. The 
Commission's justification for the proposed rule was based on available 
data showing that a statistically stable, non-zero percentage of the 
women studied had an HI greater than one and that an HI less than or 
equal to one is necessary ``to ensure a reasonable certainty of no harm 
to children, pregnant women, or other susceptible individuals with an 
adequate margin of safety.'' See 79 FR 78334-35.
    After publication of the proposed rule, the Commission examined new 
data using the CHAP's original methodology. Based on the new data, the 
Commission determined that phthalate exposures had changed over time 
and that there were too few samples in the study with an HI above one 
to make a statistically reliable estimate for the population of the 
number or percentage of women of reproductive age with an HI greater 
than one. No new data on infants were available, so risk estimates for 
this population did not change in the updated analysis. Based on the 
new data for women of reproductive age, the Commission found that the 
risk of antiandrogenic effects had decreased, and that the HI at the 
95th percentile had decreased from five to less than one. 82 FR 49958. 
Based on the new data, the Commission could not determine exactly what 
percentage of the women studied had an HI greater than one but did 
state that ``between two and nine real women from the sample of 538 
[women of reproductive age] had an HI greater than one.'' Id. The 
Commission's justification for the final rule was based on the facts 
that between two and nine individual samples had HI levels greater than 
one and not the 10 percent of women who had exposures described in the 
proposed rule, and that no new data on infants were available. For 
details regarding the respective justifications, potential commenters 
are directed to the preamble of the respective Federal Register notices 
for the proposed and final rule.
    The court of appeals held that the Commission did not provide 
adequate notice and comment when it changed the justification for the 
prohibitions in the proposed rule to the final rule. Accordingly, the 
Commission is publishing this notice to request public comment 
regarding the justification for the final rule.

B. Request for Comment on Cost-Benefit Analysis of Continuing Interim 
DINP Prohibition

    The Fifth Circuit held that the final phthalates rule was deficient 
because it did not consider the costs and benefits of continuing the 
interim prohibition on DINP. Specifically, the court found that the 
Commission was required at least to consider the cost, as well as the 
effect on utility and availability of products containing DINP, to 
determine whether to continue the interim prohibition.
    The staff of the Directorate for Economic Analysis has conducted a 
cost-benefit analysis regarding continuing the interim prohibition on 
DINP in the final rule. The staff memorandum ``Cost-Benefit Analysis of 
Continuing the Interim DINP Prohibition in the Final Rule: 16 CFR part 
1307 `Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates' '' can be found here. https://www.cpsc.gov/s3fs-public/CostBenefitAnalysisDINPinPhthalatesFinalRule.pdf?VersionId=4dQErAhY2cQdvQpf1I8rAqTNCjinie_h. The Commission requests public comment regarding 
the cost-benefit analysis of continuing the interim prohibition on DINP 
in the final rule.

III. Submission of Comments

    We request comments on two issues: The rationale for the final rule 
in section II.A; and the cost-benefit analysis of continuing the DINP 
interim prohibition discussed in section II.B of this document. Only 
comments submitted regarding the rationale for the final rule and/or 
the cost-benefit analysis of continuing the DINP interim prohibition 
will be considered. Comments submitted on any other issues are out of 
scope and will not be considered. Finally, untimely submitted comments 
will not be considered.
    Information regarding the court decision is available on the CPSC 
website or http://www.regulations.gov, under Docket No. CPSC-2014-0033, 
Supporting and Related Materials. Alternatively, interested parties may 
obtain a copy of the court decision by writing or calling the Division 
of the Secretariat, Consumer Product Safety Commission, 4330 East West 
Highway, Bethesda, MD 20814; telephone (301) 504-6833.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-06223 Filed 3-23-22; 8:45 am]
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