[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 [www.gpo.gov]
[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: [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. 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:
     The American Chemistry Council (ACC);
     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
     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: 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. 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.
     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.
     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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     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.''
     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.
     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 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.

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