Rule2022-06223
Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 24, 2022
Issuing agencies
Consumer Product Safety Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 57 (Thursday, March 24, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
instructions for submitting comments. The CPSC does not accept comments
submitted by electronic mail (email), except through <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <a href="/cdn-cgi/l/email-protection#76150605155b1905361506051558111900"><span class="__cf_email__" data-cfemail="f093808393dd9f83b093808393de979f86">[email protected]</span></a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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: <a href="/cdn-cgi/l/email-protection#fd8e8d8f928d988fbd9e8d8e9ed39a928b"><span class="__cf_email__" data-cfemail="dcafacaeb3acb9ae9cbfacafbff2bbb3aa">[email protected]</span></a>.
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. <a href="https://www.cpsc.gov/s3fs-public/CostBenefitAnalysisDINPinPhthalatesFinalRule.pdf?VersionId=4dQErAhY2cQdvQpf1I8rAqTNCjinie_h">https://www.cpsc.gov/s3fs-public/CostBenefitAnalysisDINPinPhthalatesFinalRule.pdf?VersionId=4dQErAhY2cQdvQpf1I8rAqTNCjinie_h</a>. 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>, 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]
BILLING CODE 6355-01-P
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