[Federal Register Volume 82, Number 167 (Wednesday, August 30, 2017)]
[Rules and Regulations]
[Pages 41163-41172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18387]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1308

[Docket No. CPSC-2016-0017]


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

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Consumer Product Safety Commission (Commission, or CPSC) 
is issuing a final rule that determines that certain plastics with 
specified additives would not contain the specified phthalates 
prohibited in children's toys and child care articles. Based on these 
determinations, the specified plastics with specified additives will 
not require third party testing for compliance with the mandatory 
prohibitions on children's toys and child care articles containing 
phthalates.

DATES: The rule is effective on September 29, 2017.

FOR FURTHER INFORMATION CONTACT: John W. Boja, Lead Compliance Officer, 
Regulatory Enforcement, Office of Compliance and Field Operations, 
Consumer Product Safety Commission, 4330 East West Highway Bethesda, MD 
20814-4408; telephone: 301-504-7300; email: <a href="/cdn-cgi/l/email-protection#167c74797c77567566657538717960"><span class="__cf_email__" data-cfemail="3258505d585372514241511c555d44">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

A. Background

1. Third Party Testing and Burden Reduction

    Section 14(a) of the Consumer Product Safety Act, (CPSA), as 
amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), 
requires that manufacturers of products subject to a consumer product 
safety rule or similar rule, ban, standard, or regulation enforced by 
the CPSC, must certify that the product complies with all applicable 
CPSC-enforced 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).

2. Prohibitions in Section 108 of the CPSIA

    Section 108(a) of the CPSIA permanently prohibits 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'' that 
contains concentrations of more than 0.1 percent of di(2-ethylhexyl) 
phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate 
(BBP). 15 U.S.C. 2057c(a). Section 108(b)(1) prohibits on an interim 
basis (i.e., until the Commission promulgates a final rule), the 
manufacture for sale, offer for sale, distribution in commerce, or 
importation into the United States of ``any children's toy that can be 
placed in a child's mouth'' or ``child care article'' containing 
concentrations of more than 0.1 percent of diisononyl phthalate (DINP), 
diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP). 15 U.S.C. 
2057c(b)(1). Children's toys and child care articles subject to the 
content limits in section 108 of the CPSIA require third party testing 
for compliance with the phthalate content limits before the 
manufacturer can issue a Children's Product Certificate (CPC) and enter 
the children's toys or child care articles into commerce.
    The CPSIA required the Commission to appoint a Chronic Hazard 
Advisory Panel (CHAP) to ``study the effects on children's health of 
all phthalates and phthalate alternatives as used in children's toys 
and child care articles.'' 15 U.S.C. 2057c(b)(2). The CHAP issued

[[Page 41164]]

its report in July 2014.\1\ Based on the CHAP report, the Commission 
published a notice of proposed rulemaking (NPR),\2\ proposing to 
permanently prohibit children's toys and child care articles containing 
concentrations of more than 0.1 percent of DINP, and proposing to lift 
the interim statutory prohibitions with respect to DIDP and DnOP. In 
addition, the NPR proposed adding four new phthalates, DIBP, DPENP, 
DHEXP, and DCHP, to the list of phthalates that cannot exceed 0.1 
percent concentration in accessible component parts of children's toys 
and child care articles. The Commission has not finalized its proposal 
on phthalates in children's toys and child care articles. As the 
determinations NPR noted, the research providing the basis for the 
determinations covers the six phthalates subject to the statutory 
prohibition, as well as the additional phthalates the Commission 
proposed to prohibit in children's toys and child care articles. This 
determinations final rule lists only the six phthalates subject to the 
statutory prohibition. However, when the Commission issues a final rule 
for the specified prohibited phthalates in children's toys and child 
care articles, the Commission will revise the list of prohibited 
phthalates in children's toys and child care articles to reflect the 
phthalates prohibited in the final rule.
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    \1\ http://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf.
    \2\ https://www.federalregister.gov/articles/2014/12/30/2014-29967/prohibition-of-childrens-toys-and-child-care-articles-containing-specified-phthalates.
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B. The Proposed Rule

    On August 17, 2016, the Commission published an NPR in the Federal 
Register, which proposed determinations that polypropylene (PP), 
polyethylene (PE), high-impact polystyrene (HIPS), and acrylonitrile 
butadiene styrene (ABS), with specified additives, would not contain 
the specified phthalates prohibited in children's toys and child care 
articles. See 81 FR 54754. A determination means that third party 
testing of the specified plastics with specified additives is not 
required to demonstrate compliance with the phthalates prohibitions on 
children's toys and child care articles. The NPR describes the CPSC's 
contracts with Toxicology Excellence for Risk Assessment (TERA) to 
conduct research on phthalates and provide CPSC with two research 
reports on phthalates that are the primary basis for the 
determinations.

C. Comments on the NPR

    CPSC received 11 comments on the NPR. Below, we summarize the key 
issues raised by the comments and provide responses.

1. General and Technical Comments

    Some commenters express support for the proposed rule as a means to 
reduce third party testing costs.
    Comment 1: A commenter asserts that the proposed rule erroneously 
listed a catalyst as an additive. The commenter notes that a catalyst 
is not an additive and should not have been listed as such in the 
proposed rule.
    Response 1: The commenter is correct that a catalyst is not an 
additive, but rather, is used to accelerate chemical reactions, and 
therefore, is not intended to be an additive that provides a feature 
(e.g., color, flame resistance) to a plastic. However, plastic 
manufacturing processes can leave small amounts of catalyst in the 
resultant resin. These unrecovered catalysts can be considered trace 
materials or nonfunctional additives. Consequently, the Commission has 
changed ``catalyst,'' used in the text of the proposed rule, to 
``unrecovered catalyst'' in the text of the final rule, to more 
precisely identify any catalysts that remain in the plastic resin after 
manufacture.
    Comment 2: Commenters suggest several editorial changes to the Task 
12 report and the preamble of the final rule. The commenters suggested 
the following changes, among others, to the preamble of the rule:
    <bullet> Use ``propylene'' instead of ``PP monomer'';
    <bullet> Use ``ethylene'' instead of ``PE monomer'';
    <bullet> Note that many additives are not added to virgin PE, and 
not all additives will be included in most plastic used by 
manufacturers;
    <bullet> No longer list benzene as a raw material for HIPS; and
    <bullet> No longer state that Ziegler-Natta catalysts are not 
directly used in the production of HIPS.
    The commenters' did not suggest changes to the codified text of the 
rule.
    Response 2: The Task 12 report is a completed work product that 
TERA produced under contract to the CPSC, and is not subject to 
modification. However, because the proposed rule was based on 
information in this report, and in the Task 11 report, we appreciate 
the technical comments and corrections. To the extent that the NPR 
relied on imprecise terminology, the preamble to the final rule uses 
the commenters' suggested changes in terminology. The Commission notes 
that several of the suggested changes to the Task 12 report have no 
bearing on the rule, and as such, no changes to the preamble to the 
rule are necessary.
    Comment 3: A commenter suggests that the CPSC should list all the 
different types of plastics that qualify for a determination by their 
Chemical Abstracts Service Registry Number (CASRN) because the lack of 
this type of helpful guidance may lead to uncertainty and confusion 
over which plastics qualify for a determination. The commenter adds 
that many plastics have different types, not all of which may qualify 
for a determination that third party testing is not required.
    Response 3: The Task 11 and Task 12 reports used both specific 
CASRNs and common chemical names (e.g., polyethylene, polypropylene, 
HIPS, and ABS). Therefore, CPSC considers that a CASRN or a common 
chemical name is acceptable for use as a plastic identifier because the 
contractor's research indicates that none of the terms for the plastics 
researched showed that these plastics contain the specified phthalates 
in concentrations greater than 0.1 percent.
    Suppliers may use the common name and not the CASRN to identify the 
plastics sold to component part manufacturers or children's product 
manufacturers. Additionally, a rule listing only CASRNs could be 
unnecessarily restrictive, excluding versions of the specified plastics 
that are equally expected always to comply with the phthalates content 
limits. Conceivably, a plastic resin plus a specific combination of 
these additives could be assigned a unique CASRN, and would be excluded 
from using the third party testing determinations, if the 
determinations were limited to a defined set of CASRNs.

2. Contamination Risk and Continued Testing

    Comment 4: A commenter states that molded plastics may become 
contaminated with phthalates if the molding machine used phthalate-
containing plastics and the molds were not cleaned before the new 
plastics were introduced. The commenter provides a theoretical example 
of polyvinyl chloride (PVC) production followed by production using one 
of the specified plastics. The commenter did not provide data regarding 
the possible levels of phthalate transfer.
    Another commenter states that hard plastics are at high risk of 
contamination with phthalates. The commenter asserts that they have 
measured the commenter has measured ``high'' concentrations of 
phthalates on

[[Page 41165]]

ABS plastic during laboratory testing. The commenter did not provide 
any data or other specific information.
    Response 4: These commenters appear to describe contamination, not 
intentional use of the specified phthalates in the plastics that are 
the subject of the current determinations proceeding. Neither commenter 
provides information about manufacturing ABS or other plastics to 
contradict the findings in the Task 12 report. Thus, we are unable to 
evaluate the commenters' claim.
    Comment 5: A commenter suggests that the CPSC should conduct or 
procure ``unbiased testing on the relevant plastics'' to assure that 
none of the prohibited phthalates is present in the plastics. The 
commenter suggests that if CPSC does not conduct such testing, then the 
current third party testing requirements should be maintained.
    Response 5: The Commission's determination that the specified 
plastics do not contain the specified phthalates at concentrations 
above 0.1 percent is based on data and information about raw materials 
and manufacturing processes that show that phthalates are not used to, 
or not present at, concentrations above 0.1 percent in the finished 
plastic. Staff has not conducted a study specifically to test products 
made with the specified plastics for the presence of the specified 
phthalates. However, staff's experience with testing and screening of 
plastic products supports the conclusion, based on the raw material and 
manufacturing process information that the specified plastics do not 
contain the specified phthalates.
    The final rule is based on information about the use and production 
of phthalates and about the production of the specific plastics. 
Therefore, a testing study is not necessary. The information shows that 
phthalates are not used as plasticizers for the specified plastics and 
do not have other uses that would result in phthalate content in the 
plastics at levels exceeding the specified limit for children's toys 
and child care articles. Thus, the final rule is not based on 
manufacturers' choices or promises to use non-phthalate formulations, 
but rather, the rule is based on technical studies demonstrating that 
phthalates have no function or value in the specified plastics.

3. Exclude Other Materials From Required Third Party Testing

    Comment 6: A commenter states that phthalates are incompatible with 
polyolefins, and that the phthalates' cost will restrict their use to 
materials ``absolutely necessary to make certain materials flexible 
when this cannot be achieved by other means.''
    Response 6: We agree that the available information supports a 
determination that the polyolefins do not contain phthalates. The rule 
specifically includes determinations for the polyolefins, polyethylene, 
and polypropylene.
    Comment 7: A commenter recommends that the Commission include rigid 
vinyl in future assessments of whether specified plastics can be 
determined not to contain the specified phthalates in concentrations 
above 0.1 percent. The commenter states that rigid vinyl typically has 
a hardness of 70 or higher as measured using the Shore D durometer test 
method.
    Another commenter suggests that the final rule incorporate a 
provision that plastics meeting a hardness specification are exempt 
from third party testing requirements. According to the commenter, 
because rigid plastics' hardness would be compromised by the addition 
of phthalates, plastics with Shore A hardness of 90 or greater are 
unlikely to contain any prohibited phthalate in concentrations above 
0.1 percent with a high degree of assurance.
    Response 7: The hardness of a plastic is not sufficient to 
determine the plastic's compliance to the prohibitions in section 108 
of the CPSIA. The Shore A and D hardness tests were never intended to 
be used as indicators of the presence of phthalates at low 
concentrations in plastics. As noted in Tab B of the staff's briefing 
package, otherwise rigid plastics can be noncompliant with the 0.1 
percent content limit for the specified phthalates. See https://www.cpsc.gov/s3fs-public/Plastics-Determinations-Final-Rule-August-16-2017.pdf?wF38T29pcl.Z5lMna6tu4Yo2HxWEZwb5.
    Plasticized polyvinyl chloride (PVC) typically contains phthalates 
in concentrations up to 40 percent or more. ``Rigid'' PVC has been 
shown to be noncompliant to the content limit of 0.1 percent. 
Furthermore, PVC is often recycled into new PVC products. Recycling of 
PVC provides a path for plasticized PVC to be used in a new ``rigid'' 
product that is noncompliant with the prohibitions in section 108 of 
the CPSIA. The determinations in the final rule for materials that do 
not, and will not, contain the specified phthalates at concentrations 
exceeding 0.1 percent are based on information about raw materials and 
manufacturing processes. Physical characteristics about finished 
products are not sufficient information to indicate that a plastic 
complies with the prohibitions of section 108 of the CPSIA.
    Comment 8: Two commenters request that the CPSC exclude other 
plastic materials from required third party testing. The commenters 
request that the Commission determine that the materials in the 
following list do not contain any prohibited phthalates in 
concentrations above 0.1 percent, and thus, are not subject to third 
party testing for certification purposes, preferably by issuing a rule 
to that effect. The commenters provide no additional data to support 
the assertions that the materials on the list do not contain any 
prohibited phthalates:

<bullet> 1,3,5-trioxane, copolymer with 1,3-dioxolane (acetal/
polyoxymethylene (POM) copolymer)
<bullet> 2,5-Furandione polymer with 1-propene (maleic anhydride 
grafted PP)
<bullet> 2,5-Furandione polymer with ethane (maleic anhydride grafted 
PE)
<bullet> Acetal/polyoxymethylene (POM) homopolymer
<bullet> Acrylic (polymethylmethacrylate and polyacrylonitrile)
<bullet> Ionomers
<bullet> Liquid crystal polymers (hydroxybenzoic acid copolymers)
<bullet> Nylon/polyamide
<bullet> Olefin thermoplastic elastomers (such as EPDM)
<bullet> Polybutene
<bullet> Polybutylene terephthalate
<bullet> Polycarbonate
<bullet> Polyesters
<bullet> Polyethylene terephthalate
<bullet> Polylactic acid
<bullet> Polyphenylene sulfide
<bullet> Polystyrene, including crystal and general-purpose (GPPS), 
medium-impact (MIPS) and super-high-impact (SHIPS) grades
<bullet> Polytetramethylene glycol-dimethyl terephthalate-1,4-
butanediol copolymer (polyester elastomer)
<bullet> Silicone rubber (pure)
<bullet> Styrene-butadiene copolymers
<bullet> Styrene-butadiene-styrene rubbers (SBS/SBR)
<bullet> Styrene-acrylonitrile copolymers (SAN)
<bullet> Vinylidene chloride/methyl acrylate copolymers
<bullet> CMYK Process Inks
<bullet> Butadiene-ethylene resins
<bullet> Butene-ethylene copolymers
<bullet> Ethylene copolymers
<bullet> Ethylene acrylic acid copolymers
<bullet> Ethylene-propylene copolymers
<bullet> Ethylene vinyl acetate copolymers
<bullet> Ethylene vinyl acetate vinyl alcohol copolymers
<bullet> Ethylene vinyl alcohol copolymers
<bullet> Propylene-ethylene copolymers.

[[Page 41166]]

    One of these commenters specifically requests that the Commission 
extend the exclusion for high-impact polystyrene (HIPS) to crystal and 
general-purpose polystyrene (GPPS, or GPS), medium-impact polystyrene 
(MIPS), and super-high-impact polystyrene (SHIPS) grades.
    Another commenter urges the CPSC to continue to review other 
plastics for exemptions from required third party testing for phthalate 
content. Finally, a commenter suggests that the Commission allow 
suppliers of novel resin and additive combinations to warrant that the 
materials comply with the requirements of the CPSIA to a high degree of 
assurance. The commenter suggests that a third party testing exception 
could be granted based on ``demonstrated data.''
    Response 8: The commenters provided no information to support their 
claim that the plastics they listed do not contain phthalates as a part 
of their manufacture or as an additive. The Commission cannot make 
determinations without such information.
    However, after submission of the NPR to the Commission, CPSC's 
contractor completed another report (the Task 16 report), which 
included information about the additional polystyrene-based plastics, 
GPPS, MIPS, and SHIPS, mentioned by the commenter. \3\ The Task 16 
report contains information regarding the potential for GPPS, MIPS, 
SHIPS, and other plastics to contain any of the specified phthalates.
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    \3\ Exposure Assessment: Potential for the Presence of 
Phthalates in Specified Materials at Concentrations Above 0.1 
Percent, Task Order 16, Contract Number CPSC-D-12-0001, August 8, 
2016, Final Report. Prepared by: Toxicology Excellence for Risk 
Assessment (TERA) University of Cincinnati. Available at: https://www.cpsc.gov/s3fs-public/ThePotentialforPhthalatesinSelectedPlastics.pdf.
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    Staff examined the Task 16 report and determined that GPPS, MIPS, 
SHIPS, and HIPS can be considered members of a family of polystyrene 
plastics. GPPS is the polystyrene component of HIPS, MIPS, and SHIPS, 
as described in the Task 12 and Task 16 reports. GPPS does not involve 
the use of phthalates in its manufacture, or as an additive. Because 
GPPS is brittle, polybutadiene rubber is added as a ``shock absorber,'' 
to increase the impact resistance of the polystyrene-butadiene mixture. 
In the manufacturing of polybutadiene, Ziegler-Natta catalysts, which 
can include DBP, DIBP, and DEHP, are used, raising the possibility that 
these phthalate components of the catalysts could remain in the 
processed plastics. However, catalysts are washed from the 
polybutadiene, and the remaining phthalate concentrations are not 
likely to exceed the 0.1 percent limit.\4\
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    \4\ Borealis, A.G. 2014. Polypropylene Products: Borealis' 
Position on Phthalates in PP Catalysts. Vienna, Austria. Available 
at: http://www.borealisgroup.com/Global/Company/Sustainability/polypropylene-products.pdf.
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    Medium-impact polystyrene consists of GPPS with about two to five 
percent butadiene added.\5\ HIPS typically contains 6 to 12 percent 
butadiene.\6\ The concentration of butadiene in SHIPS ranges from 40 to 
60 percent.\7\ All of these polystyrenes use the same materials as HIPS 
in their manufacture and use the same additives to achieve desired 
finished component part characteristics.
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    \5\ Sastri, Vinny R., (2013). Plastics in Medical Devices: 
Properties, Requirements, and Applications. William Andrew, 
publisher, ISBN 0323265634, 9780323265638. P 107.
    \6\ Ibid.
    \7\ Deanin, Rudolph D., Crugnola Aldo M. (1976). Toughness and 
Brittleness of Plastics. American Chemical Society, ISBN13: 
9780841202214. eISBN: 9780841223356. P239.
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    The Task 16 report largely referred to the information about HIPS 
summarized in the previous Task 12 report because of the lack of 
additional references for the specific polystyrene materials and the 
similarities among the various polystyrene materials described in the 
general references. No specific reference in the Task 16 report 
identified the use of phthalates in production of GPPS, MIPS, HIPS, or 
SHIPS for consumer products. Additional research by staff did not 
discover any more information, suggesting that phthalates may be used 
to produce these polystyrene-based materials.
    Because the Task 12 and 16 reports and staff's research show that 
phthalates are not used in GPPS, MIPS, and SHIPS (except as a catalyst 
to make the butadiene component), and the final concentration of 
phthalates in the polystyrene-based materials are likely to be well 
below 0.1 percent, the Commission agrees with the commenter that these 
materials can be included in the determination, along with HIPS. The 
codified text of the final rule adds GPPS, MIPS, and SHIPS to HIPS and 
the accompanying additives.
    Regarding the commenter's suggestion to allow suppliers of novel 
resin and additive combinations to warrant that the materials comply 
with the requirements of the CPSIA, section 14 of the CPSA does not 
allow warrants to substitute for required third party testing. The 
Commission could consider determinations regarding third party testing 
requirements for new plastics or other materials in the future, if 
sufficient data and other information show that third party testing is 
not required to assure compliance. Currently, the Commission lacks 
those data.
    Comment 9: A commenter request that the Commission ``publicly 
identify the many types of plastic materials that will not contain the 
restricted phthalates in excess of 0.1 percent and that can thus be 
excluded from third-party testing requirements.'' The commenter also 
suggests that the Commission consider identifying the very few types of 
plastic materials that may contain the specified phthalates, and 
presumably, restrict required third party testing to those materials 
only. The commenter asserts that either approach would ``offer added 
certainty to both testing laboratories and customers, of critical 
importance due to the high cost of phthalates testing.''
    Response 9: In this rulemaking, the Commission identifies several 
specific plastics that do not contain the specified phthalates in 
concentrations greater than 0.1 percent, based on information about raw 
materials, manufacturing processes, and other relevant factors. Any 
additional recommendations for determinations would similarly require 
data and other information to support a conclusion that the material 
does not, and will not, contain the specified phthalates. At this time, 
staff does not have evidence supporting additional plastics 
determinations, and therefore, the Commission cannot make 
determinations for additional plastics.
    Furthermore, although we understand the typical uses of phthalates 
and generally the types of products that may contain phthalates in 
concentrations exceeding 0.1 percent, we do not agree that specifying a 
list of products and materials that would have to be tested (as opposed 
to specifying materials that do not require testing to demonstrate 
conformance with the standard) is practical, given the range of 
materials that may contain phthalates and the possibility of future 
development of novel uses for the specified phthalates.

4. Rule Contrary to CPSC 2009 Statement of Policy and Public Law 112-28

    Comment 10: A commenter asserts that the proposed rule is contrary 
to section 108(c) of the CPSIA (as amended by Pub. L. 112-28). The 
commenter points to a sentence in the proposed rule at Sec.  1308.2(c):

    Accessible component parts of children's toys and child care 
articles made with a plastic or additives not listed in paragraph 
(a) of this section are required to be third party tested pursuant 
to section 14(a)(2) of the CPSA and 16 CFR part 1107.

    Section 108(c) of the CPSIA states:


[[Page 41167]]


    APPLICATION.--Effective on the date of enactment of this Act, 
subsections (a) and (b)(1) and any rule promulgated under subsection 
(b)(3) shall apply to any plasticized component part of a children's 
toy or child care article or any other component part of a 
children's toy or child care article that is made of other materials 
that may contain phthalates.

    The commenter asserts that because this language limited required 
third party testing for phthalate content to accessible plasticized 
component parts, and to component parts that may contain phthalates, 
required third party testing is limited ``to only component parts that 
have had a plasticizer added to it or to component parts that could 
contain phthalates.'' The commenter adds that required third party 
testing is therefore not required for component parts that have not 
been plasticized and materials that may not contain phthalates. The 
commenter states that the aforementioned sentence in the proposed rule 
creates a new scope by applying required phthalate testing to all 
plastics not specifically listed in the determinations.
    The commenter suggests that the language in proposed Sec.  
1308.2(c) should state:

    Accessible component parts of children's toys and child care 
articles made with a plastic or additives not listed in paragraph 
(a) of this section must still be comprised of compliant materials 
pursuant to section 108 of CPSIA, Public Law 110-314 as amended by 
H.R. 2714, Public Law 112-28.

    The commenter asserts that this change to the language recommended 
above will reflect Congressional intent and be consistent with CPSC 
phthalate testing policy that has been effectively used by some 
companies to eliminate phthalate testing on materials known to be 
compliant.
    Response 10: The commenter is correct that section 108(c) of the 
CPSIA applies to this rule and that compliance to section 108 of the 
CPSIA is limited to plasticized component parts and other materials 
that may contain phthalates. As noted in the NPR preamble, children's 
toys and child care articles are always required to comply with the 
requirements of section 108 of the CPSIA, regardless of any exceptions 
to required third party testing under section 14 of the CPSA.
    We acknowledge that Sec.  1308.2(c) of the proposed rule could be 
interpreted as conflicting with section 108(c) of the CPSIA. Thus, we 
have revised Sec.  1308.2(c) in the final rule to clarify that the rule 
concerns accessible component parts of children's toys and child care 
articles made from materials that are plasticized or may contain 
phthalates.
    We are making this change because, if a manufacturer or importer 
(i.e., a certifier) of a children's toy or child care article has 
accessible component parts that have been plasticized, or are composed 
of a material that may contain phthalates, third party testing is 
required to assure compliance to section 108 of the CPSIA. Examples of 
materials that may contain phthalates include, but are not limited to, 
plastics (for which a determination has not been made), inks, solvents, 
surface coatings, adhesives, and some rubberized materials.
    Comment 11: Two commenters claim that the NPR reverses the 
Commission's 2009 Statement of Policy, which, according to the 
commenters, lists a number of plastic materials other than the four 
plastics in the NPR that are not subject to third party testing for 
certification purposes. Another commenter states that the proposed rule 
``appears to negate the flexibility afforded in the 2009 Statement of 
Policy document on phthalates.'' The commenter suggests that ``the 
flexibility granted by the CPSC's Statement of Policy should be 
maintained.'' The commenter asserts that this flexibility allows 
suppliers with supply chain knowledge to use their discretion when 
determining which materials to subject to third party testing.
    Response 11: The Commission's 2009 guidance document, Statement of 
Policy: Testing of Component Parts With Respect To Section 108 of the 
Consumer Product Safety Improvement Act,\8\ was intended to provide 
general guidance. It listed a number of materials that might not 
require third party testing. In contrast, the determination rule 
specifies that third party testing is not required for specified 
plastics with accompanying additives. The determination does not remove 
flexibility, but provides a clear pathway for manufacturers to know 
that third party testing is not required if they use the specific 
plastics and additives listed in the determination.
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    \8\ https://cpsc.gov/s3fs-public/pdfs/blk_media_componenttestingpolicy.pdf.
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5. Due Care and Certification

    Comment 12: A commenter suggests that the Commission state whether 
a Certificate of Compliance (COC) is required for plastics for which a 
third party testing determination has been made. The commenter states 
that if a COC is required when third party testing is not necessary, 
additional due diligence would be needed to ensure that the plastic 
material qualifies for a determination. The commenter suggests adding 
to the final rule a ``due care'' provision, similar to the provision in 
16 CFR part 1109 (the component part testing rule).\9\ The commenter 
contends that the due care requirement should apply to the phthalates 
determinations because of the inherent complexity involved with 
properly identifying the specific plastics and additives that would be 
exempt from testing.
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    \9\ http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title16/16cfr1109_main_02.tpl, Section 1109.4 (g) states: ``Due care 
means the degree of care that a prudent and competent person engaged 
in the same line of business or endeavor would exercise under 
similar circumstances. Due care does not permit willful ignorance.''
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    Another commenter states that importers often have limited 
knowledge of their products' materials and lack the evidence to 
demonstrate compliance without testing. The commenter suggests that 
manufacturers use an Attenuated Total Reflectance (ATR) sensor to 
identify materials that do not contain prohibited phthalates.
    The commenter requested that the preamble clarify that 
manufacturers must use due diligence to ensure that their products only 
have plastics that are covered by the determination. The commenter 
states that screening tests, conducted on a first party basis, would 
reduce third party testing costs while ensuring compliance to the 
CPSIA.
    Response 12: The final rule addresses third party testing 
requirements for specified plastics to assure compliance to section 108 
of the CPSIA. Certification of products subject to a children's product 
safety rule is required, regardless of whether third party testing is 
required. A certifier or testing party must exercise due care to ensure 
that no action or inaction after testing, and before distribution in 
commerce, would affect compliance, including contamination or 
degradation, while a component part or finished product is in its 
custody. Thus, the component part testing rule establishes due care 
requirements for certifiers or testing parties. To repeat the 
requirements in this rule would be redundant and unnecessary.
    Comment 13: A commenter suggests that the final rule clarify that 
when certifying parties are relying on third party testing 
determinations for certification purposes, laboratories do not have the 
responsibility for:
    <bullet> Determining the type of plastic;
    <bullet> Verifying that the plastic is what a supplier declares;
    <bullet> Confirming that there has been no contamination; and

[[Page 41168]]

    <bullet> Confirming there have been no material changes through 
supply chain traceability and production safeguards.
    The commenter asserts that these responsibilities reside with the 
certifying party (domestic manufacturer or importer).
    Response 13: We agree with the commenter that the manufacturer or 
importer of a children's product is responsible for the product's 
certification. Laboratories have limited responsibilities regarding 
certification issues. Unless a laboratory, on behalf of a manufacturer 
or importer, voluntarily chooses to be a children's product or 
component part certifier, the laboratory is not responsible for the 
compliance of a tested product to the applicable children's product 
safety rules. The manufacturer or importer is responsible for meeting 
the requirements of 16 CFR parts 1107 and 1109, which generally include 
the responsibilities listed by the commenter.

6. Research Does Not Demonstrate High Degree of Assurance

    Comment 14: A commenter asserts that the research does not provide 
a high degree of assurance that the specified plastics do not contain 
any of the specified phthalates in concentrations above 0.1 percent 
because data are lacking on how phthalates are used, where they occur, 
and their migration. The commenter also expresses concern about 
phthalates in recycled materials.
    The commenter provides as examples:
    <bullet> The presence or concentration of the specified phthalates 
in polyethylene was not reported in TERA report.
    <bullet> Other studies cited in the Task 12 report and patents for 
toys and child care products did not include information on the 
presence of phthalates in ABS.\10\
---------------------------------------------------------------------------

    \10\ TERA Task 12 report, page 57.
---------------------------------------------------------------------------

    <bullet> Zeigler-Natta catalysts (which can contain the prohibited 
phthalates) could remain in high-impact polystyrene at a concentration 
of 0.0001 percent, but no test data had been supplied to support that 
claim.
    <bullet> There is a lack of information on phthalates in recycled 
plastics; and
    <bullet> Information on the possibility of a plastic's 
contamination with a specified phthalate is also lacking.
    Response 14: CPSC disagrees with the assertion that data are 
lacking to support the determination. The available information 
identifies how and where phthalates are used, and also shows the 
chemicals and processes used to manufacture the specified plastics. 
Therefore, the Commission considers the available information provides 
support for the conclusion that the specified plastics do not contain 
phthalates at levels exceeding the specified limit for children's toys 
and child care articles.
    We agree that few studies directly measured phthalate content in 
the specified plastics. However, we expected that such studies might be 
rare, given that the available information does not indicate that 
phthalates might be present.
    We acknowledge that the literature on recycling is not as extensive 
as the data on phthalates and plastics manufacturing. Nonetheless, we 
consider all of the information about phthalates' use and occurrence to 
indicate that recycling could result in plastics that contain traces of 
phthalates. We expect that residual levels would be well below the 
maximum-allowed concentration in children's toys and child care 
articles.
    In work done by a contractor and presented in the Task 12 and 16 
reports, the contractor was faced with ``proving a negative,'' i.e., 
showing that phthalates are not present in the specified plastics. The 
contractor employed a tiered approach to research the specified 
plastics. This approach narrowed the field of possible sources and 
assisted in identifying information that was not available (data gaps) 
so that focused efforts could be directed in those areas. In the Task 
12 report, from a ``universe'' of more than 109 million sources, the 
contractor screened 119,800 articles for relevant information on the 
four plastics and phthalates. The contractor states:

    Given the search strategy and its success at getting the other 
information, we can be confident that if there had been information 
on the phthalate content of the four plastics we would have found 
it. In fact, the consistent lack of information amongst the many 
places we searched, both secondary authoritative web and library 
sources and primary literature sources made us highly confident that 
there was very little information on the specified phthalates in the 
four plastics.\11\
---------------------------------------------------------------------------

    \11\ Tera Task 12 report, page 55.

    In the Task 16 report, the contractor screened more than 179,000 
sources for relevant information on the specified plastics and 
phthalates in a nonbiased manner that was representative of the world 
wide literature on this subject matter. As in the Task 12 report, the 
contractor states that its Task 16 report search strategy and its 
success at obtaining other information gives them confidence that, if 
there had been information on the phthalate content of the specified 
plastics, then they would have found it.
    Thus, for the reasons discussed above, CPSC considers the Task 12 
and 16 reports to provide a high degree of assurance that the specified 
plastics do not contain any prohibited phthalates in concentrations 
above 0.1 percent.
    Comment 15: A commenter recommends that the Commission exercise 
``extreme caution and skepticism with unproved claims of compliance 
with CPSC requirements.'' The commenter expresses concern about 
unintentional or unknown factors that could result in the presence of 
phthalates. The commenter claims that many toys have disconnected and 
global supply chains, and that as a consequence, U.S. toy importers 
often rely on laboratory test results from foreign suppliers. The 
commenter cites the alleged failure of an importer to meet a state 
standard as evidence that CPSC should exercise caution and skepticism.
    Response 15: The rule is primarily based on information in the TERA 
Task 11, 12, and 16 reports about use and production of phthalates, and 
about the production of specified plastics. The available information 
shows that phthalates are not used as plasticizers for the specified 
plastics, and are not otherwise found in the plastics at levels 
exceeding the specified limits for children's toys and child care 
articles. The determinations in this rule are not based on suppliers' 
assertions, manufacturer's laboratory test results, or other industry 
attestations. We consider the information in the TERA Task 12 and 16 
reports, and the additional staff research, to be sufficient to make a 
determination with a high degree of assurance that the specified 
plastics are compliant with section 108 prohibitions without requiring 
third party testing.
    Regarding the commenter's concerns about unintentional or unknown 
factors, we note that manufacturers and importers are required to have 
a high degree of assurance that their products are compliant to the 
applicable children product safety rules. Furthermore, manufacturers 
and importers are responsible for exercising due care to ensure their 
children's products comply with the applicable children's product 
safety rules. 16 CFR 1109.5(b)(3).
    Comment 16: A commenter states that the contractor (TERA) engaged 
by the CPSC to study phthalate use and investigate the presence of 
phthalates in four specified plastics may have a conflict of interest. 
The commenter notes TERA's past litigation support for regulated 
industries. The commenter asserts TERA's potential conflict of

[[Page 41169]]

interest is exemplified in a 2016 paper sponsored by a chemical 
manufacturers' trade group.\12\
---------------------------------------------------------------------------

    \12\ Approaches for describing and communicating overall 
uncertainty in toxicity characterizations: U.S. Environmental 
Protection Agency's Integrated Risk Information System (IRIS) as a 
case study. The publication can be found at: https://www.ncbi.nlm.nih.gov/pubmed/26827183.
---------------------------------------------------------------------------

    The commenter adds that TERA is a founding member of the Alliance 
for Risk Assessment (ARA). The ARA's Standing Panel includes the TERA 
founder, two industry consultants, employees of Dow Chemical and 
ExxonMobil, and two government employees. The commenter alleges that, 
in light of TERA's relationship with ExxonMobil, TERA's conclusions 
should be viewed with caution.
    Response 16: We consider TERA to be an independent organization 
\13\ that focuses on advancing the science of toxicology and risk 
assessment. We do not agree that work by TERA or individual TERA staff 
in scientific projects, workshops, or publications concerning 
industrial chemicals or products or that include chemical firms, 
industry employees, or trade organizations necessarily indicates 
unreliable performance or improper influence in CPSC contract work.
---------------------------------------------------------------------------

    \13\ Staff notes that after the contract work discussed here, 
TERA reorganized as the Risk Science Center at the University of 
Cincinnati: https://med.uc.edu/eh/centers/rsc.
---------------------------------------------------------------------------

    As standard procedure, CPSC reviews potential conflicts of interest 
before awarding a contract or task order. We did not identify any 
conflicts for TERA related to the investigation of the production and 
use of phthalates or the production of the specified plastics.
    We do not agree that the membership in ARA is evidence of a 
potential conflict of interest. Rather, we consider ARA to be a 
transparent, multi-stakeholder scientific collaboration to develop risk 
assessment information to advance public health activities. 
Furthermore, the commenter does not specify any projects by the ARA 
that suggest that the contracted TERA work is affected by potential 
conflicts of interest.
    In summary, the commenter did not provide any specific information 
that shows that the reports produced by TERA under contract with CPSC 
have been affected by potential conflicts of interest. Nor did the 
commenter show that the reports contain inaccurate or misleading data 
or information.

7. Out of Scope Comments

    We also received comments on issues such as random spot checking 
for certificates of compliance, developing a procedure for petitioning 
the Commission for determinations, identifying statistical averaging 
and margins of error under which products could still be considered 
compliant, allowing other techniques beyond materials determinations 
for lead content testing that could reduce third party testing costs, 
asking Congress for authority to implement commenter's suggestions, 
determinations for lead content, and the inclusion of supply chain 
controls when noncompliant products are found. This rulemaking is 
limited to determinations regarding phthalate content in specified 
plastics. The aforementioned comments are outside the scope of this 
rulemaking.

D. Determinations for Specified Plastics With Certain Additives

1. Legal Requirements for a Determination

    As noted above, section 14(a)(2) of the CPSA requires third party 
testing for children's products that are subject to a children's 
product safety rule. 15 U.S.C. 2063(a)(2). Children's toys and child 
care articles must comply with the phthalates prohibitions in section 
108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction, 
the Commission has investigated approaches that would reduce the burden 
of third party testing while also assuring compliance with CPSC 
requirements. As part of that endeavor, the Commission has considered 
whether certain materials used in children's toys and child care 
articles would not require third party testing.
    To issue a determination that a plastic (including specified 
additives) does not require third party testing, the Commission must 
have sufficient evidence to conclude that the plastic and specified 
additives would consistently comply with the CPSC requirement to which 
the plastic (and specified additives) is subject so that third party 
testing is unnecessary to provide a high degree of assurance of 
compliance. Under 16 CFR 1107.2, ``a high degree of assurance'' is 
defined as ``an evidence-based demonstration of consistent performance 
of a product regarding compliance based on knowledge of a product and 
its manufacture.''
    For a material determination, a ``high degree of assurance of 
compliance'' means that the material will comply with the specified 
chemical limits due to the nature of the material or due to a 
processing technique that reduces the chemical concentration below its 
limit. For materials determined to comply with a chemical limit, the 
material must continue to comply with that limit if it is used in a 
children's product subject to that requirement. A material on which a 
determination has been made cannot be altered or adulterated to render 
it noncompliant and then used in a children's product.
    The determinations will only relieve the manufacturer's obligation 
to have the specified plastics and accompanying additives tested by a 
CPSC-accepted third party conformity assessment body. Children's toys 
and child care articles must still comply with the substantive 
phthalates content limits in section 108 of the CPSIA, regardless of 
any relief from third party testing requirements. Additionally, the 
manufacturer must issue a certificate stating that the product complies 
with CPSC requirements.
    Phthalates are not naturally occurring materials, but are 
intentionally created and used in specific applications (e.g., 
plastics, surface coatings, solvents, inks, adhesives, and some 
rubberized materials). One application of phthalates in children's toys 
and child care articles is as a plasticizer, or softener for plastic 
component parts.\14\ The addition of a plasticizer converts an 
otherwise rigid plastic into a more flexible form, such as in a child's 
rubber duck or a soft plastic doll. Because plastics used in children's 
toys and child care articles can contain the prohibited phthalates, 
third party testing is required before a CPC can be issued for 
children's toys and child care articles with accessible plastic 
component parts. However, some specific plastics with certain additives 
might not use any of the prohibited phthalates as a plasticizer, or for 
any other purpose. For these specific plastics and accompanying 
additives, compliance with the requirements of section 108 of the CPSIA 
can be assured without requiring third party testing. To reduce the 
third party testing burden on children's product certifiers while 
continuing to assure compliance, the CPSC has determined with a high 
degree of assurance that the specified plastics with certain additives 
comply with the phthalate content requirements of section 108 of the 
CPSIA, based on evidence indicating that such materials will not 
contain the prohibited phthalates. These determinations mean that third 
party testing for compliance with the phthalates prohibitions is not 
required for certification purposes for the specified four plastics. 
The Commission makes these

[[Page 41170]]

determinations to reduce the third party testing burden on children's 
product certifiers while continuing to assure compliance.
---------------------------------------------------------------------------

    \14\ The Merriam-Webster online dictionary defines a plasticizer 
as ``a chemical added especially to rubbers and resins to impart 
flexibility, workability, or stretchability.''
---------------------------------------------------------------------------

2. Statutory Authority

    Section 3 of the CPSIA grants the Commission general rulemaking 
authority to issue regulations, as necessary, to implement the CPSIA. 
Public Law 110-314, sec. 3, Aug. 14, 2008. As noted previously, section 
14 of the CPSA, as amended by the CPSIA, requires third party testing 
for children's products subject to a children's product safety rule. 15 
U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by 
Public Law 112-28, gives the Commission the authority to ``prescribe 
new or revised third party testing regulations if it 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.'' Id. 2063(d)(3)(B). These statutory 
provisions authorize the Commission to issue a rule determining that 
specified plastics and additives will not exceed the phthalates 
prohibitions of section 108 of the CPSIA, and therefore, specified 
plastics do not require third party conformity assessment body testing 
to assure compliance with the phthalates limits in section 108 of the 
CPSIA.
    The determinations will relieve the specified plastics and 
accompanying additives from the third party testing requirement of 
section 14 of the CPSA to support the required certification. However, 
the determinations would not apply to any other plastic or additives 
beyond those listed in the rule.

3. Description of the Final Rule

    The rule creates a new part 1308 for ``Prohibition of Children's 
Toys and Child Care Articles Containing Specified Phthalates: 
Determinations Regarding Certain Plastics.'' The rule determines 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.
    Section 1308.1 of the rule explains the statutorily created 
requirements for children's toys and child care articles under section 
108 of the CPSIA and the third party testing requirements for 
children's products. This section is unchanged from the proposed rule. 
As discussed in section A.2 of the preamble, currently, the agency is 
involved in rulemaking to determine whether to continue the interim 
prohibitions in section 108 and whether to prohibit any other 
children's products containing any other phthalates. At the time of 
publication of this final rule in the Federal Register, the Commission 
has not issued a final rule in the phthalates rulemaking. Therefore, 
this determinations rule lists the phthalates that are statutorily 
prohibited from being in children's toys and child care articles under 
section 108 of the CPSIA.
    Section 1308.2(a) of the rule establishes the Commission's 
determinations that the following seven plastics do not exceed the 
phthalates content limits with a ``high degree of assurance'' as that 
phrase is defined in 16 CFR part 1107. Section 1308.2(a) of the rule is 
being finalized as proposed, except for the following changes. The 
final rule:
    <bullet> Adds ``naphthenic oil'' to the list of PP plasticizers in 
Sec.  1308.2(a)(1)(i). Naphthenic oil is a nonphthalate plasticizer 
listed with paraffinic and mineral plasticizing oils in a Task 12 
report reference and should have been included in the proposed rule but 
was inadvertently omitted;
    <bullet> Adds the word ``unrecovered'' before ``catalysts'' in 
Sec. Sec.  1308.2(a)(1)(iii), (a)(2)(iv), (a)(3)(i), (a)(4)(vii) of the 
final rule to clarify that this additive refers to small amounts of 
catalyst that may remain in a plastic resin after manufacture;
    <bullet> Adds general purpose polystyrene (GPPS), medium-impact 
polystyrene (MIPS), and super high-impact polystyrene (SHIPS) to Sec.  
1308.2(a)(3), to high-impact polystyrene (HIPS) that was listed in the 
proposed rule, to the list of materials that can be determined not to 
require third party testing in order to assure compliance with section 
108 of the CPSIA. This change is made based on a commenter's suggestion 
and supporting information from the Task 16 report. These three 
plastics, along with HIPS, can be considered members of a family of 
polystyrene plastics manufactured with the same raw materials and 
processes. The potential additives for GPPS, MIPS, and SHIPS are the 
same as those for HIPS;
    <bullet> Replaces the term ``phosphate esters'' in Sec.  
1308.2(a)(4)(i) with ``hydrocarbon processing oil, triphenyl phosphate, 
resorcinol bis(diphenyl phosphate), and oligomeric phosphate'' to more 
precisely identify the ABS plasticizers listed. The specific phosphate 
esters added were listed and discussed in the preamble of the NPR and 
the underlying staff briefing package, but were inadvertently left out 
of the codified text in the NPR; and
    <bullet> Deletes ``hydrocarbon solvents'' from the list of 
additives for PP in Sec.  1308.2(a)(1)(ii) and ABS in Sec.  
1308.2(a)(4)(ii) because hydrocarbon solvents are not additives but 
rather are used in the production of resin. The list of additives in 
Sec. Sec.  1308.2(a)(1)(ii) and (a)(4)(ii) has been renumbered to 
reflect this change.
    Section 1308.2(b) of the rule states that accessible component 
parts of children's toys and child care articles made with the 
specified plastics, and specified additives listed in paragraph (a) of 
this section, are not required to be third party tested pursuant to 
section 14(a)(2) of the CPSA and 16 CFR part 1107. Section 1308.2(b) is 
included in the rule to make clear that when the listed plastics and 
accompanying additives are used in children's toys and child care 
articles, manufacturers and importers are not required to conduct the 
third party testing required in section 14(a)(2) of the CPSA and 16 CFR 
part 1107. This provision is unchanged from the proposed rule.
    Section 1308.2(c) of the rule has been revised to add the phrase 
``that are plasticized or may contain phthalates'' between ``in 
paragraph (a) of this section'' and ``are required to be third party 
tested.'' The new language tracks the statutory language of section 
108(c) of the CPSIA regarding component parts of children's toys or 
child care articles that are plasticized or may contain phthalates. If 
a manufacturer or importer (i.e., a certifier) of a children's toy or 
child care article has accessible component parts that have been 
plasticized, or are composed of a material that may contain phthalates, 
third party testing is required to assure compliance to section 108 of 
the CPSIA. This change has been made because the language of Sec.  
1308.2(c) of the proposed rule could be interpreted as conflicting with 
section 108(c) of the CPSIA.

E. Effective Date

    The Administrative Procedure Act (APA) generally requires that a 
substantive rule must be published not less than 30 days before its 
effective date. 5 U.S.C. 553(d)(1). The Commission proposed a 30-day 
effective date because the rule provides relief from existing testing 
requirements under the CPSIA. No comments were received regarding the 
effective date. The effective date for the rule is 30 days from the 
date of publication of the rule in in the Federal Register.

[[Page 41171]]

F. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires 
agencies to consider the impact of proposed and final rules on small 
entities, including small businesses. Section 604 of the RFA requires 
that agencies prepare a final regulatory flexibility analysis (FRFA) 
when promulgating final rules, unless the head of the agency certifies 
that the rule will not have a significant impact on a substantial 
number of small entities. The FRFA must describe the impact of the rule 
on small entities. CPSC staff prepared a FRFA. See Tab C of staff's 
briefing package at https://www.cpsc.gov/s3fs-public/Plastics-Determinations-Final-Rule-August-16-2017.pdf?wF38T29pcl.Z5lMna6tu4Yo2HxWEZwb5. We provide a summary below.
    The rule is intended to reduce the burden of third party testing on 
manufacturers of children's toys and child care articles consistent 
with assuring compliance with CPSC requirements under section 14 of the 
CPSA, as amended by section 2 of Public Law 112-28. The final rule 
would reduce the burden of third party testing on manufacturers and 
importers of children's toys and child care articles by establishing 
determinations for certain plastics (PP, PE, GPPS, MIPS, HIPS, SHIPS, 
and ABS) and accompanying additives. Based on these determinations, the 
specified plastics with specified additives will not require third 
party testing for compliance with the mandatory prohibitions on 
children's toys and child care articles containing phthalates.
    Although comprehensive estimates of the number of products that 
contain components made from the specified plastics are not available, 
there is some evidence that these plastics are extensively used in 
children's toys. One source stated that polypropylene and high-density 
polyethylene are used in 38 and 25 percent, respectively, of injection-
molded toys.\15\ The same source also stated that low-density 
polyethylene, polystyrene, and acrylonitrile butadiene styrene, are 
each used in less than 10 percent of injection-molded toys.
---------------------------------------------------------------------------

    \15\ Donald V. Rosato, Plastics End Use Applications, Springer, 
New York, (2011).
---------------------------------------------------------------------------

    Based on the number of domestic toy manufacturers that are 
classified as small businesses by the U.S. Bureau of the Census, and 
evidence that the specified plastics are used extensively in toys, 
staff believes a substantial number of small entities would be impacted 
positively by this regulation.
    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. The cost of third party 
testing for phthalates is between approximately $125 and $350 per test, 
depending on where the testing is conducted and any discounts that 
might be applicable.\16\ Because one product might have several 
component parts that require testing, the cost to test a finished 
product for phthalate content may be substantially higher. To the 
extent that small entities have lower production volumes than larger 
entities, these determinations would be expected to have a 
disproportionately beneficial impact on small entities because the 
costs of the tests are distributed over fewer units. Additionally, some 
laboratories may offer their larger customers discounts that might not 
be available to small entities that need fewer third party tests. 
However, the benefit of making the determinations could be less than 
might be expected. For example, some manufacturers might have already 
substantially reduced their third party phthalate testing costs by 
using the component part testing under 16 CFR part 1109. Therefore, the 
marginal benefit that might be derived from making the determinations 
might be low. Some importers might not be certain of what materials are 
actually being used in each component part and might not be able to use 
the determinations without testing.
---------------------------------------------------------------------------

    \16\ The cost estimates of third party phthalate testing are 
based on information provided both by consumer product manufacturers 
and by testing laboratories.
---------------------------------------------------------------------------

    Under section 604 of the Regulatory Flexibility Act, a FRFA should 
include a ``statement of the factual, policy, and legal reasons for 
selecting the alternative adopted in the final rule and why each one of 
the other significant alternatives to the rule considered by the agency 
which affect the impact on small entities was rejected.'' The final 
rule is itself, the result of CPSC's efforts to reduce third party 
testing costs consistent with assuring compliance with all applicable 
consumer product safety rules. Therefore, CPSC considered few 
alternatives, other than expanding the list of plastics for which 
determinations could be made. We note that the final rule includes 
determinations for three additional polystyrenes (GPPS, MIPS, and 
SHIPS) that were not included in the NPR.

G. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
Commission rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). This rule falls within the categorical exclusion, so no 
environmental assessment or environmental impact statement is required. 
The Commission's regulations state that safety standards for products 
normally have little or no potential for affecting the human 
environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that 
expectation.

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 title 16 of the Code of Federal 
Regulations by adding part 1308 to read as follows:

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

Sec.
1308.1 Prohibited children's toys and child care articles containing 
specified phthalates and testing requirements.
1308.2 Determinations for specified plastics.

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


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). Section 108(b)(1) of the CPSIA prohibits on an interim 
basis any children's toy that can be placed in a child's mouth or child 
care article that contains concentrations of more than 0.1 percent of 
diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl 
phthalate (DnOP). Materials used in children's toys and child care 
articles subject to section 108(a) and (b)(1) of the CPSIA 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.

[[Page 41172]]

Sec.  1308.2  Determinations for specified plastics.

    (a) The following plastics do not exceed the phthalates content 
limits with a high degree of assurance as that term is defined in 16 
CFR part 1107:
    (1) Polypropylene (PP), with any of the following additives:
    (i) The plasticizers polybutenes, dioctyl sebacate, isooctyl 
tallate, paraffinic, naphthenic, and mineral plasticizing oils, and 
polyol;
    (ii) Unrecovered catalysts;
    (iii) Fillers;
    (iv) Primary and secondary antioxidants;
    (v) Neutralizing agents;
    (vi) Antistatic agents;
    (vii) Slip agents;
    (viii) Metal deactivators;
    (ix) Quenchers;
    (x) UV stabilizers;
    (xi) Nucleating agents;
    (xii) Flame retardants;
    (xiii) Blowing or foaming agents;
    (xiv) Antiblocking agents;
    (xv) Lubricants; or
    (xvi) Colorants.
    (2) Polyethylene (PE), with any of the following additives:
    (i) The plasticizers glyceryl tribenzoate, polyethylene glycol, 
sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM 
rubber, and EVA polymer;
    (ii) Initiators;
    (iii) Promoters;
    (iv) Unrecovered catalysts;
    (v) Fillers;
    (vi) Antistatic agents;
    (vii) Flame retardants;
    (viii) Anti-blocking agents;
    (ix) Slip agents;
    (x) Blowing agents;
    (xi) Cross-linking agents;
    (xii) Antioxidants;
    (xiii) Carbon black; or
    (xiv) Colorants.
    (3) General purpose polystyrene (GPPS), medium-impact polystyrene 
(MIPS), high-impact polystyrene (HIPS), and super high-impact 
polystyrene (SHIPS) with any of the following additives:
    (i) Unrecovered catalysts;
    (ii) Internal lubricants;
    (iii) Chain transfer/transition agents;
    (iv) Stabilizers;
    (v) Diluents;
    (vi) Colorants;
    (vii) Aluminum chloride, ethyl chloride, hydrochloric acid;
    (viii) Iron oxide, potassium oxide, chromium oxide; or
    (ix) Bifunctional peroxides.
    (4) Acrylonitrile butadiene styrene (ABS), with any of the 
following additives:
    (i) The plasticizers hydrocarbon processing oil, triphenyl 
phosphate, resorcinol bis(diphenyl phosphate), oligomeric phosphate, 
long chain fatty acid esters and aromatic sulfonamide;
    (ii) Stabilizers;
    (iii) Lubricants;
    (iv) Antioxidants;
    (v) Molecular weight regulators;
    (vi) Initiators/unrecovered catalysts,
    (vii) Activators;
    (viii) Emulsifiers; or
    (ix) Colorants.
    (b) Accessible component parts of children's toys and child care 
articles made with the specified plastics, and specified additives, 
listed in paragraph (a) of this section are not required to be third 
party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 
1107.
    (c) Accessible component parts of children's toys and child care 
articles made with a plastic or additives not listed in paragraph (a) 
of this section that are plasticized or may contain phthalates are 
required to be third party tested pursuant to section 14(a)(2) of the 
CPSA and 16 CFR part 1107.

    Dated: August 25, 2017.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-18387 Filed 8-29-17; 8:45 am]
BILLING CODE 6355-01-P


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