Rule2022-25811
Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates
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Published
December 5, 2022
Issuing agencies
Consumer Product Safety Commission
Abstract
The Consumer Product Safety Commission (Commission or CPSC) is publishing this document in response to a federal court decision remanding the Commission's final phthalates rule, without vacatur, to allow the Commission to address two procedural deficiencies the court found. This document provides notice of the availability of CPSC staff's memorandum responding to public comments on the justification for the phthalates final rule and on the staff's cost-benefit analysis of continuing the interim prohibition on diisononyl phthalate (DINP). This document also provides the Commission's finding that further rulemaking is not warranted at this time.
Full Text
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<title>Federal Register, Volume 87 Issue 232 (Monday, December 5, 2022)</title>
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[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Rules and Regulations]
[Pages 74311-74314]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25811]
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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: Availability of Response to Comments and Commission Finding.
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SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is
publishing this document in response to a federal court decision
remanding the Commission's final phthalates rule, without vacatur, to
allow the Commission to address two procedural deficiencies the court
found. This document provides notice of the availability of CPSC
staff's memorandum responding to public comments on the justification
for the phthalates final rule and on the staff's cost-benefit analysis
of continuing the interim prohibition on diisononyl phthalate (DINP).
This document also provides the Commission's finding that further
rulemaking is not warranted at this time.
DATES: December 5, 2022.
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#f48784869b849186b497848797da939b82"><span class="__cf_email__" data-cfemail="e49794968b948196a487949787ca838b92">[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. 15 U.S.C.
2057c(b)(3). The Commission was required to ``determine, based on such
report, whether to continue in effect'' the statutory 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)(1), (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).
On December 30, 2014, the Commission published a notice of proposed
rulemaking (NPR) in the Federal Register. 79 FR 78324. The NPR stated
the Commission proposed to prohibit the manufacture for sale, offer for
sale, distribution in commerce, or importation into the United States
of any children's toy or child care article containing any of the
phthalates specified in the proposed rule. 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 to the NPR and final rule provide 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 other
parties 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 the phthalates final rule to the CPSC to address two
procedural deficiencies the court found. Tex. Ass'n. of Mfrs. v. CPSC,
989 F.3d 368 (5th Cir. 2021). As relevant here, the court held that the
final rule 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 as a permanent prohibition. Because the
court did not vacate the final rule, the rule has remained in effect
since 2018.
II. Staff's Response to Comments
In March 2022, the Commission published a request for comment from
the public regarding the two procedural deficiencies the court found.
87 FR 16635 (March 24, 2022). The notice sought public comment on the
justification for the final rule, and on the staff's costs and benefits
analysis (CBA) regarding continuing the statutory interim prohibition
on DINP. CPSC received four public comments (excluding duplicates). The
commenters were:
<bullet> The American Chemistry Council (ACC);
<bullet> A group consisting of the Natural Resources Defense
Council, the Environmental Justice Health Alliance for Chemical Policy
Reform, Public Citizen, Coming Clean, Earthjustice, the Campaign for
Healthier Solutions, and Breast Cancer Prevention Partners
(collectively, NRDC et al.); and
<bullet> Two individuals (Maranda and Harding).
Two of the four comments (NRDC et al. and Harding) were largely
supportive of the rule and of the staff CBA. Two of the four comments
(ACC and Maranda) were critical of the rule and of the staff CBA but
did not present new data or information within scope of the notice
requesting comments. Based on its analysis of the comments and the
scope of the court's remand, CPSC staff recommends no further action is
necessary to revise the final rule. Section II of this document
provides a brief overview of the in-scope comments received in response
to the March 2022 request for comment and staff's responses. The
complete staff analysis of the comments, including those outside the
scope of the request, can be found in the memorandum, ``Staff Responses
to Request for Comments on Final Rule: 16 CFR part 1307 `Prohibition of
Children's Toys and Child Care Articles Containing Specified
Phthalates,''' available at: <a href="https://www.cpsc.gov/s3fs-public/Staff-Responses-to-Request-for-Comments-on-Final-Rule-16-CFR-Part-1307-Prohibition-of-Childrens-Toys-and-Child-Care-Articles-Containing-Specified-Phthalates.pdf?VersionId=RWiDEFGrye2fjlalXFSayKafroEj4C7l">https://www.cpsc.gov/s3fs-public/Staff-Responses-to-Request-for-Comments-on-Final-Rule-16-CFR-Part-1307-Prohibition-of-Childrens-Toys-and-Child-Care-Articles-Containing-Specified-Phthalates.pdf?VersionId=RWiDEFGrye2fjlalXFSayKafroEj4C7l</a>.
A. Comments on Justification for the Phthalates Final Rule
Below are brief descriptions of the comments that were submitted on
the issues presented for public input regarding the justification for
the final rule, and staff's analysis of those comments.
<bullet> NRDC et al. commented that the court remanded the rule to
correct procedural issues, not for CPSC to reevaluate the underlying
science or examine new data provided after the final rule was issued in
2017. Staff agrees with the commenter that data submitted after the
rule issuance in 2017 are not within the proper scope of this
proceeding on remand.
<bullet> NRDC et al. commented that the data confirm that the rule
is necessary to provide a reasonable certainty of no harm to children,
pregnant women, or other susceptible individuals with an adequate
margin of safety. In contrast, ACC and Maranda commented that the data
in the administrative record did not
[[Page 74312]]
support the final rule. Staff responds explaining that the
justification for the proposed rule was based, in part, on the CHAP's
2014 finding that 5 percent of infants and 10 percent of pregnant women
had a HI greater than one.\1\ When the 2017 final rule was issued,
phthalate exposures in women of reproductive age--a surrogate for
pregnant women--had declined, but some women of reproductive age had a
hazard index (HI) greater than one. New data on infants and pregnant
women were not available. Staff, therefore, concluded that absent
continuation of the interim prohibition, phthalate exposures and risks
would be inconsistent with the Commission's statutory obligation to
``ensure a reasonable certainty of no harm with an adequate margin of
safety.'' 15 U.S.C. 2057c(b)(3)(A).
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\1\ Section 108(b)(2)(iii) of the CPSIA directed the CHAP to
``examine the likely levels of children's, pregnant women's, and
others' exposure to phthalates . . .''
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<bullet> ACC commented that data published by the Centers for
Disease Control and Prevention after the final rule was issued
undermined the final rule by demonstrating declining phthalate
exposures in the general population, as well as women of reproductive
age. Staff's response explains why the data did not undermine the rule,
and instead demonstrated the effectiveness of this and similar rules,
and why the data were not relevant to the court's remand.
<bullet> Maranda commented that the CHAP proved that DINP is safe.
Staff disagrees that the CHAP found that DINP is ``safe'' and notes
that the CHAP specifically recommended that the interim prohibition on
DINP be continued.
B. Comments on Cost-Benefit Analysis of Continuing the Interim
Prohibition of DINP
Below are brief descriptions of the in-scope comments that were
submitted on the staff's analysis of the costs and benefits of
continuing the interim prohibition on DINP.
Costs Issues
Comments were submitted on the following issues regarding the costs
of continuing the interim prohibition on DINP.
<bullet> ACC commented that that the CBA underestimated the likely
economic costs of maintaining the interim prohibition on DINP, while
NRDC et al. argued that the CBA overestimated the costs. Harding
commented that the CBA showed that the prohibition on DINP protects
vulnerable populations without significant costs. Staff's response
explains why the CBA did not underestimate or overestimate those costs.
<bullet> ACC provided alternate ``baseline'' scenarios to estimate
the costs and benefits of the rule, given its allegation that many
suppliers currently do not comply with the rule. ACC also stated that
CPSC should have considered the costs to suppliers' confiscation and
destruction of illegally imported products containing violative levels
of DINP. Staff's response notes that the CBA analyzed the costs of
compliance with the rule for all applicable suppliers, and the benefits
to consumers and society from the reduced exposure to phthalates
resulting from that compliance, which was the scope of analysis
required by the court's remand.
<bullet> Citing information from the CBA on the cost of
reformulation for toy suppliers, ACC commented that there is evidence
that DINP is still cost-effective after the CPSIA's interim prohibition
because it is being used in toys sold in foreign countries. Staff's
response notes that ACC did not provide new information or data on
prices of toys or DINP before or after the rule that CPSC could use to
quantify the impacts on foreign businesses or importers, which CPSC
previously discussed and analyzed in the CBA.
<bullet> ACC commented that the rule created a ``stigma'' around
DINP and thus, had a negative impact on markets for other consumer
goods, causing consumers to demand DINP-free flooring, for example.
NRDC et al. commented that the CBA ``appropriately rejects'' the notion
that the interim prohibition on DINP or the final rule meaningfully
affected the general market transition away from phthalates to non-
phthalate plasticizers. Staff's response notes that, as discussed in
the CBA, consumer opposition to phthalates in consumer products other
than toys began before the enactment of the CPSIA and the promulgation
of the final rule and has continued to grow after the final rule went
into effect, as evidenced by recent state-level legislation that
applies to many products outside the scope of CPSC's jurisdiction.
<bullet> ACC commented that although the price of toys declined
during the interim prohibition, the CPSC did not prove that the rule
had no impact on the retail price of toys, because prices could have
been even lower absent the rule. ACC suggested that CPSC should have
done more analysis of other inputs and production costs that might have
impacted the price of toys for consumers. NRDC et al. generally
expressed support for the analysis in the CBA that continuation of the
interim prohibition on DINP had no measurable impact on the prices for
either DINP or toys. Staff's response notes that ACC did not provide
any specific data showing that other input or production costs changed,
or that such changes increased the price of toys to U.S. consumers.
Furthermore, the CBA did not state that the rule had no impact on the
price of toys, but rather, assessed that ``the impact was minor, both
in absolute terms and compared to other impacts on the market.'' No
commenters representing consumers stated that the interim prohibition
had raised the price of toys or child care articles, nor did any toy or
child care article importers provide such comments.
<bullet> ACC commented that there may have been additional negative
effects on the market for phthalates and plasticizers that CPSC failed
to analyze. Staff's response notes that commenters did not provide any
new information to support or counter the analysis in the CBA, which
noted that there might be additional, non-quantifiable effects on the
markets for both plasticizers and toys.
<bullet> Two commenters, ACC and NRDC et al., commented on CPSC's
characterization of the consistency of the final rule with state and
international regulations and laws. ACC indicated that staff overstated
the consistency with other regulations, some of which apply only to
mouthable toys, while NRDC et al. commented that the analysis was
correct. Staff's response notes that commenters did not provide new
information on this subject, or how it would impact the costs of toys,
and that the CBA did not claim the final rule was identical to
regulations in other states and countries, but rather, that the rule
was largely consistent.
<bullet> NRDC et al. stated in their view, that CPSC did not need
to conduct a cost-benefit analysis, because the CPSIA's requirement
that the final rule provides a ``reasonable certainty of no harm . . .
with an adequate margin of safety,'' made no mention that cost should
be a criterion. Staff's response notes that the court's decision found
that the agency is required to conduct a cost-benefit analysis for the
final rule regarding whether to continue the interim prohibition on
DINP.
Benefits Issues
Below are brief descriptions of the in-scope comments that were
submitted on the benefits analysis in the CBA, and staff's responses.
<bullet> Two commenters, NRDC et al. and Harding, found the
analysis of benefits generally persuasive. Two commenters, ACC and
Maranda, found the estimates
[[Page 74313]]
generally unpersuasive. Staff's response notes that no commenter
provided new data on benefits that was within the scope of
consideration, such as different data about the medical costs of
treating Testicular Dysgenesis Syndrome (TDS) and explained how the CBA
addressed the commenters' concerns.
<bullet> ACC commented that the CPSC should have used different
data and models to estimate benefits and that the CHAP report was
``dated'' and should not have been used as the basis for the CBA; nor
should CPSC have used the 2013-14 National Human Health and Nutrition
Survey (NHANES) data when more recent 2017-18 data are available. NRDC
et al. pointed out that the court stated that the CPSC's decision to
use the 2013-14 data, and to protect the 99th percentile from harm, is
consistent with CPSC's mandate to ``ensure a reasonable certainty of no
harm.'' 15 U.S.C. 2057c(b)(3)(A). Staff's response notes that CPSC
based its benefits estimate on the CHAP as required by the CPSIA, and
on the data available at the time of the final rule. Staff asserts that
data on phthalate exposure after the rule was published are not
relevant to the rule's analysis of harm caused by the phthalate
exposure, as noted above. The CHAP focused on TDS as the toxicity
endpoint for phthalate exposure; therefore, the benefits analysis
focused on the benefits of reducing the incidence of TDS. The CBA
discusses in detail other peer-reviewed literature that quantified the
harm of other toxicity endpoints for phthalate exposure.
<bullet> NRDC et al. agreed with staff that reduced cases of TDS
are the ``essential benefit'' of making the interim prohibition
permanent; thus, it was appropriate that the CBA benefits section
focuses on the estimated cost per case of TDS and the costs to society
of TDS caused by phthalate exposure from children's toys that can be
placed in a child's mouth and child care articles. ACC noted that the
CBA referenced various peer-reviewed journal articles that discussed
other potential adverse health effects, in addition to TDS, from
phthalate exposure. ACC urged CPSC to quantify these effects, rather
than allegedly just suggest that these unquantified impacts provide
further evidence that the benefits exceed the costs of the final rule.
Commenter Harding found the exposure data used to justify the final
rule was ``weak and insufficient,'' but also noted that ``the rule
would significantly decrease the exposure of medically vulnerable
people like children and pregnant women to the dangerous phthalate
without impacting the economy.'' Commenter Maranda stated: ``because
the evidence found is not substantial enough the Commission should
reject this proposed rule,'' and further asserted that ``the CHAP has
proven DINP to be safe again and again.'' Staff's response notes that
none of the comments presented new, in-scope data that are relevant to
the estimated benefits of the final rule, such as a quantitative
estimate of the contribution of DINP to the cumulative impact of other
endocrine-disrupting chemicals, a quantitative estimate of other
negative health impacts of DINP exposure, the number of cases of TDS
caused by DINP exposure, or different estimates of the cost per case.
Staff disagrees with Maranda's assertion that the CHAP found DINP to be
``safe.''
<bullet> NRDC et al. commented that although the CBA discussed
disparate impacts in the benefits analysis, CPSC should ``explicitly
consider the environmental justice benefits of addressing these
historic and continuing disproportionate impacts when weighing the
benefits and costs of continuing the DINP ban.'' Staff's response notes
that the commenter did not provide additional data to analyze
environmental justice benefits but noted in the CBA that phthalate
exposures appear to be higher in infants, children, and women from
Black, non-Hispanic populations, and populations living in poverty than
persons in other groups, and therefore, the rule may disproportionately
benefit persons from vulnerable populations. Staff also notes that the
regulation offers the same protection from DINP exposure from new toys
and child care articles to all consumers, and there are no exceptions
to the rule for small suppliers or for inexpensive items.
<bullet> ACC commented that the primary exposure to DINP from toys
and childcare articles may be from exposure to phthalates in household
dust, rather than through mouthing, and that the CBA should have
analyzed the benefits from reducing this type of exposure. Staff's
response notes that the CBA based the analysis of benefits on the
findings of the CHAP and that the CHAP did analyze household dust as a
source of phthalate exposure for women, infants, and children.
C. Out-of-Scope Comments
The Commission's March 2022 Federal Register notice stated that
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, and that comments submitted on any other issues are
out of scope and will not be considered. Staff's memorandum notes that
most of the issues raised by commenters did not address the rationale
used to justify the final rule, or they repeated comments that were
previously submitted on the proposed rule and considered and addressed
at that time. Similarly, the comments on the staff CBA either raised
information that staff included in the CBA or suggested that the CBA
should have considered out-of-scope issues other than costs of
compliance with a continued prohibition on DINP or the associated
benefits to consumers, such as the rule's impact on foreign companies
that deliberately violate it. More specific responses to out-of-scope
comments can be found in the memorandum ``Staff Responses to Request
for Comments on Final Rule: 16 CFR part 1307 ``Prohibition of
Children's Toys and Child Care Articles Containing Specified
Phthalates''' available at <a href="https://www.cpsc.gov/s3fs-public/Staff-Responses-to-Request-for-Comments-on-Final-Rule-16-CFR-Part-1307-Prohibition-of-Childrens-Toys-and-Child-Care-Articles-Containing-Specified-Phthalates.pdf?VersionId=RWiDEFGrye2fjlalXFSayKafroEj4C7l">https://www.cpsc.gov/s3fs-public/Staff-Responses-to-Request-for-Comments-on-Final-Rule-16-CFR-Part-1307-Prohibition-of-Childrens-Toys-and-Child-Care-Articles-Containing-Specified-Phthalates.pdf?VersionId=RWiDEFGrye2fjlalXFSayKafroEj4C7l</a>.
III. Commission Finding Regarding Need for Further Rulemaking
The court's remand directed that: ``The Commission must allow
industry to comment and consider the new justification for the Final
Rule. Further, it must consider the costs of continuing Congress's
interim prohibition on DINP to determine whether the rule is
`reasonably necessary' to protect from harm.'' Tex. Ass'n. of Mfrs.,
989 F.3d at 389-90.
CPSC has taken the following actions in response to the court's
remand. CPSC staff drafted a CBA regarding continuing the interim
prohibition on DINP. In March 2022, the Commission published a Federal
Register notice requesting public comment regarding the change in the
primary justification from the proposed rule to the final rule, and on
staff's CBA assessing a continuation of the interim prohibition on
DINP. The Commission is publishing this document to provide public
notice of the availability of staff's response to comments and the
Commission's finding that further rulemaking is not necessary.\2\
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\2\ The Commission voted 4-0 to approve publication of this
notice.
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The March 2022 notice specifically stated comments were being
solicited on only the two specific issues remanded by the court, and
that ``Comments submitted on any other issues are out of scope and will
not be considered.'' 87
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FR at 16636. The Commission adheres to the path charted by the court,
considering only the specific issues raised in the court's remand.
Therefore, comments that raise issues beyond the scope of the remand
are rejected as being outside the scope of this proceeding.\3\
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\3\ Staff nevertheless provided substantive responses to many of
the out-of-scope comments, which the Commission adopts to the extent
the comments might be deemed relevant.
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As described in Section II of this document, staff considered and
responded to the comments received in response to the March 2022 public
notice. The Commission has considered the comments submitted in
response to the March 2022 notice and the CPSC staff's assessment of
those comments and does not find any of the comments submitted to be
persuasive such that it would justify a change to the phthalates final
rule. Therefore, the Commission determines that no further rulemaking
activity to revise the phthalates final rule is warranted. Having
considered the issues identified by the court on remand, and the record
generated in response to the court's remand, the Commission considers
the matter concluded.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2022-25811 Filed 12-2-22; 8:45 am]
BILLING CODE 6355-01-P
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