[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Proposed Rules]
[Pages 54055-54062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21517]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1253

[Docket No. CPSC-2019-0023]


Children's Toys and Child Care Articles: Determinations Regarding 
ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission (CPSC) is proposing a 
rule to determine that certain unfinished manufactured fibers would not 
contain the ASTM F963 elements or specified phthalates that exceed the 
limits set forth under the CPSC's statutes and regulations for 
children's toys and child care articles. Based on these proposed 
determinations, the specified unfinished manufactured fibers would not 
be required to have third party testing for compliance with the 
requirements of the ASTM F963 elements or phthalates for children's 
toys and child care articles.

DATES: Submit comments by December 23, 2019.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2019-
0023 by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: www.regulations.gov. Follow the instructions for 
submitting comments. The CPSC does not accept comments submitted by 
electronic mail (email), except through www.regulations.gov. The CPSC 
encourages you to submit electronic comments by using the Federal 
eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Division of the Secretariat, Consumer Product 
Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 
20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All

[[Page 54056]]

comments received may be posted without change, including any personal 
identifiers, contact information, or other personal information 
provided, to: www.regulations.gov. Do not submit confidential business 
information, trade secret information, or other sensitive or protected 
information that you do not want to be available to the public. If 
furnished at all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: www.regulations.gov, and insert the docket 
number CPSC-2019-0023, into the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Jacqueline Campbell, Senior Textile 
Technologist, Office of Hazard Identification and Reduction, U.S. 
Consumer Product Safety Commission, 5 Research Place, Rockville, MD 
20850: telephone 301-987-2024; email: [email protected].

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) 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.'' Id. 2063(d)(3)(B).
    To provide opportunities to reduce the cost of third party testing 
requirements consistent with assuring compliance with any applicable 
consumer product safety rule, ban, standard, or regulations, the CPSC 
assessed whether children's toys and child care articles manufactured 
with seven manufactured fibers: polyester (polyethylene terephthalate, 
PET), nylon, polyurethane (spandex), viscose rayon, natural rubber 
latex, acrylic, and modacrylic, would comply with CPSC's requirements 
for ASTM F963 elements or phthalates. If the Commission determines that 
such materials will comply with CPSC's requirements with a high degree 
of assurance, manufacturers do not need to have those materials tested 
by a third party testing laboratory to issue a Children's Product 
Certificate (CPC).

2. ASTM F963 Elements

    Section 106 of the CPSIA provides that the provisions of ASTM 
International, Consumer Safety Specifications for Toy Safety (ASTM 
F963), shall be considered to be consumer product safety standards 
issued by the Commission.\1\ 15 U.S.C. 2056b. The Commission has issued 
a rule that incorporates by reference the relevant provisions of ASTM 
F963. 16 CFR part 1250.\2\ Thus, children's toys subject to ASTM F963 
must be tested by a CPSC-accepted third party laboratory and 
demonstrate compliance with all applicable CPSC requirements for the 
manufacturer to issue a CPC before the children's toys can be entered 
into commerce.
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    \1\ ASTM F963 is a consumer product safety standard, except for 
section 4.2 and Annex 4, or any provision that restates or 
incorporates an existing mandatory standard or ban promulgated by 
the Commission or by statute.
    \2\ The Commission is not proposing to incorporate ASTM F963 by 
reference into part 1253.
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    Section 4.3.5 of ASTM F963 requires that surface coating materials 
and accessible substrates of children's toys that can be sucked, 
mouthed, or ingested \3\ must comply with the solubility limits of 
eight elements given in Table 1 of the toy standard. The materials and 
their solubility limits are shown in Table 1. We refer to these eight 
elements as ``ASTM F963 elements.''
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    \3\ ASTM F963 contains the following note regarding the scope of 
the solubility requirement: NOTE 4--For the purposes of this 
requirement, the following criteria are considered reasonably 
appropriate for the classification of children's toys or parts 
likely to be sucked, mouthed or ingested: (1) All toy parts intended 
to be mouthed or contact food or drink, components of children's 
toys which are cosmetics, and components of writing instruments 
categorized as children's toys; (2) Children's toys intended for 
children less than 6 years of age, that is, all accessible parts and 
components where there is a probability that those parts and 
components may come into contact with the mouth.

  Table 1--Maximum Soluble Migrated Element in ppm (mg/kg) for Surface
            Coatings and Substrates Included as Part of a Toy
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                                                              Solubility
                          Elements                              limit,
                                                               (ppm) 4
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Antimony (Sb)..............................................           60
Arsenic (As)...............................................           25
Barium (Ba)................................................         1000
Cadmium (Cd)...............................................           75
Chromium (Cr)..............................................           60
Lead (Pb)..................................................           90
Mercury (Hg)...............................................           60
Selenium (Se)..............................................          500
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    The third party testing burden could be reduced only if all 
elements listed in section 4.3.5 have concentrations below their 
solubility limits. Because third party conformity assessment bodies 
typically run one test for all of the ASTM F963 elements, no testing 
burden reduction would be achieved if any one of the elements requires 
testing.
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    \4\ The method to assess the solubility of a listed element is 
detailed in section 8.3.2, Method to Dissolve Soluble Matter for 
Surface Coatings, of ASTM F963. Modeling clays included as part of a 
toy have different solubility limits for several of the elements.
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    To alleviate some of the third party testing burdens associated 
with the ASTM F963 elements in the accessible component parts of 
children's toys, the Commission determined that certain unfinished and 
untreated trunk wood does not contain ASTM F963 elements that would 
exceed the limits specified in section 106 of the CPSIA. Based on this 
determination, unfinished and untreated trunk wood would not require 
third party testing for the ASTM F963 elements. 16 CFR part 1251. The 
Commission also has determined that untreated and unfinished engineered 
wood products would not require third party testing for the ASTM 
elements or specified phthalates (discussed below) for children's 
products, children's toys, and child care products. 16 CFR part 1252.

3. Phthalates

    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).
    The CPSIA required the Commission to appoint a Chronic Hazard 
Advisory Panel (CHAP) to ``study the effects on

[[Page 54057]]

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 its report in July 2014. On October 27, 2017, the 
Commission published a final rule in the Federal Register, 
``Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates,'' 82 FR 49938, prohibiting children's toys and 
child care articles containing concentrations greater than 0.1 percent 
of: di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); benzyl 
butyl phthalate (BBP); diisononyl phthalate (DINP); diisobutyl 
phthalate (DIBP); di-n-pentyl phthalate (DPENP); di-n-hexyl phthalate 
(DHEXP); or dicyclohexyl phthalate (DCHP). These restrictions 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 phthalates prohibitions are set forth in 16 CFR part 1307.
    Tests for phthalate concentration are among the most expensive 
certification tests to conduct on a product, and each accessible 
component part subject to section 108 of the CPSIA must be tested. 
Third party testing burden reductions can occur only if each 
phthalate's concentration is below 0.1 percent (1000 ppm). Because 
laboratories typically run one test for all of the specified 
phthalates, no testing burden reduction likely is achieved if any one 
of the phthalates requires compliance testing.

B. Contractor's Research

    The CPSC contracted with the Toxicology Excellence for Risk 
Assessment (TERA, or the contractor) to conduct literature reviews on 
the production of certain undyed manufactured fibers and to evaluate 
whether the specified manufactured fibers potentially contain (1) any 
of the specified chemical elements that are included in the toy 
standard in concentrations \5\ exceeding specified limits, or (2) any 
of 10 specified phthalates in concentrations greater than 0.1 percent 
(1000 ppm). TERA researched the following manufactured fibers: 
polyester (polyethylene terephthalate, PET), nylon, polyurethane 
(spandex), viscose rayon, natural rubber latex, acrylic, and 
modacrylic. Staff reviewed the information provided in the TERA report, 
Exposure Assessment: Potential for the Presence of Phthalates and Other 
Specified Elements in Undyed Manufactured Fibers and their Colorants 
(the report, Task 17).\6\ TERA's Task 17 report formed the basis for 
the proposed unfinished manufactured fiber determinations. For more 
detailed information on the Task 17 report and staff analysis please 
see the staff briefing package. https://www.cpsc.gov/s3fs-public/Draft%20NPR-%20Children%27s%20Toys%20and%20Child%20Care%20Articles-%20Determinations%20Regar....pdf?IB4eKjJ_meZH1vdT5uQeojG8FfYGeqD9.
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    \5\ Although the ASTM F963-17 standard for chemical elements is 
a solubility requirement, TERA researched total content, in part 
because of the expected availability of content data versus 
solubility data and because content is a conservative stand-in for 
chemical solubility (i.e., the content of a chemical is the same 
value as one hundred percent solubility of the chemical from 
solubility testing).
    \6\ Task Order 17, Contract Number CPSC-D-12-0001. Available at: 
https://www.cpsc.gov/s3fs-public/TERA%20Task17%20Report%20Phthalates%20and%20ASTM%20Elements%20in%20Manufactured%20Fibers.pdf.
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    All of the fibers covered in the Task 17 report are manufactured 
and do not naturally occur in a fiber state. Although their raw 
starting materials may be different, these fibers are generally 
extruded into a fiber form. In many cases, additional chemicals may be 
added before the extrusion process so that the chemicals are embedded 
in the fiber structure. To better understand where the specified 
phthalates or ASTM elements may be present, TERA documented the fiber 
chemical characteristics, manufacturing processes, typical colorants, 
and any other relevant information found through their search strategy.

C. CPSC Staff Analysis of TERA Task 17 Report

    CPSC staff reviewed the TERA Task 17 Report. CPSC staff also 
examined TERA's source references to better understand the report's 
findings. The Task 17 Report focused on the possibility of the ASTM 
F963 elements and specified phthalates being present in seven 
manufactured fiber types.

Unfinished Fibers

    The TERA report found one significant use of an ASTM element in 
unfinished manufactured fibers: antimony in the production of polyester 
(PET) fibers at concentrations of about 150-300 ppm, amounts that would 
exceed the solubility limit specified in ASTM F963. Staff does not have 
information identifying the amount of the antimony that is soluble when 
tested according to ASTM F963. PET fiber is widely used in consumer 
textile products, including children's toys. The contractor report did 
not identify any other instances of the use of ASTM elements or 
phthalates in the routine manufacturing processes for the specified 
unfinished fibers.
    Compliance to the ASTM F963 standard can be demonstrated by 
measuring the chemical content of a material--if the total content for 
a specific element does not exceed the solubility limit, then it must 
be the case that the solubility requirement is met. Because information 
about solubility or migration of chemicals from products or materials 
is rarely available in the scientific literature or other data sources, 
staff relies on information about chemical content to understand 
possible uses and presence of chemicals in products. If sufficient 
solubility testing data were available, especially if data show low 
levels of migration, such data may help inform decisions about testing 
requirements under the ASTM F963 standard.
    In addition to intentional use of the specified chemicals, staff 
considered whether contaminants or impurities may be present in 
unfinished fibers, yarns, or fabrics. In the review of the contractor 
report, the reports referenced by the contractor, and other reference 
materials, staff has not found any information or data that suggest 
contaminants would be present in fibers at significant levels. Reported 
contaminant levels, such as for arsenic, chromium, mercury, or cadmium, 
are no higher than a few parts per million. Staff believes that 
contaminants or impurities are unintentional (i.e., not added by the 
manufacturer intentionally), and largely represent the ubiquity of some 
substances in the environment at trace levels or general industrial 
practices and conditions. Given the available data and staff's 
understanding of the raw materials and manufacturing practices for the 
fibers currently under consideration, staff concludes that any 
impurities will be at levels well below the relevant limits for this 
proceeding.

Dyed or Finished Fibers (or Fibers With Chemical Additives Pre-Fiber 
Formation)

    Colorants, such as dyes, often contain metals in their structure. 
The contractor report cited the use of mercury, arsenic, barium, or 
chromium in dyes or dye auxiliaries. For example, chrome dyes are a 
type of acid dye that can be used on nylon fibers and contains chromium 
to form a complex between the dye and the fiber. Because the use of 
these metals is not necessarily limited to a specific dye class or 
fiber type, staff cannot rule out the use of these metals at 
concentrations greater than those

[[Page 54058]]

specified in ASTM F963 without more information. Furthermore, the 
contractor report cited the potential use of some of the specified 
phthalates as dye auxiliaries or carriers for pigments. Although some 
of the findings may have been with products not necessarily within the 
scope of the subject rules, the mechanism by which colorants are 
applied to fibers could be extended to those products.
    Finishes may also be added at the fiber (yarn or fabric) stage to 
impart desirable characteristics. The contractor report highlighted the 
use of antimony compounds as flame retardants. Other chemicals of 
interest may be used in finished fiber (yarn or fabric); however, those 
finishes were not within the scope of the contractor report, and more 
information is necessary to consider whether determinations for 
finished fiber (yarn or fabric) are appropriate. Staff notes that in 
the case of the ASTM elements (excluding lead, which has separate 
specific restrictions under the CPSIA), the restriction in the ASTM 
F963 standard is based on solubility; i.e., migration of the elements 
from the product or material.

Recycled Content

    TERA did not examine the potential use of recycled materials in the 
subject manufactured fibers. Staff is aware that recycled content is 
present in some textile fibers; however, staff does not know the extent 
to which recycled content can be expected in products within the scope 
of the ASTM F963 elements or phthalates requirements. Due to findings 
in the contractor report on colorants and finishes in manufactured 
fibers, staff does not recommend determinations for fibers with 
recycled content unless such content was from unfinished recycled 
materials.

D. Determinations for Unfinished Manufactured Fibers

1. Legal Requirements for a Determination

    As discussed in section A.1. of the preamble, 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 must comply with the limits on the ASTM F963 elements 
incorporated in 16 CFR part 1250. Children's toys and child care 
articles must comply with the phthalates prohibitions in section 108 of 
the CPSIA and 16 CFR part 1307. 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 manufactured fiber does not require 
third party testing, the Commission must have sufficient evidence to 
conclude that the product consistently complies with the CPSC 
requirements to which the manufactured fiber is subject so that third 
party testing is unnecessary to provide a high degree of assurance of 
compliance. Under 16 CFR part 1107 section 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 accessible component parts of children's toys and child care 
articles subject to sections 106 and 108 of the CPSIA and 16 CFR part 
1307, compliance to the specified content limits is always required, 
irrespective of any testing exemptions. Thus, a manufacturer or 
importer who certifies a children's toy or child care article, must 
assure the product's compliance. The presence of the ASTM F963 elements 
or the specified phthalates does not have to be intended to require 
compliance. The presence of these chemicals, whether for any functional 
purpose, as a trace material, or as a contaminant, must be in 
concentrations less than the specified content or solubility limits for 
the material to be compliant. Additionally, the manufacturer or 
importer must have a high degree of assurance that the product has not 
been adulterated or contaminated to an extent that would render it 
noncompliant. For example, if a manufacturer or importer is relying on 
a determination that a manufactured fiber does not contain the ASTM 
F963 elements or specified phthalates in concentrations greater than 
the specified limits in a children's toy or child care article, the 
manufacturer must ensure that the manufactured fiber is one on which a 
determination has been made.
    Furthermore, under the proposed rule, any determinations that are 
made on manufactured fibers are limited to unfinished manufactured 
fibers. Children's toys and child care articles made from these 
manufactured fibers may have other materials that are applied to or 
added on to the manufactured fiber after it is manufactured, such as 
colorants and flame retardants. Such component parts fall outside of 
the scope of the proposed determinations and would be subject to third 
party testing requirements, unless the component part has a separate 
determination that does not require third-party testing for 
certification purposes. Finally, even if a determination is in effect 
and third party testing is not required, a certifier must still issue a 
certificate.
    The six unfinished manufactured fibers for which determinations are 
proposed for the ASTM F963 elements are: Nylon, polyurethane (spandex), 
viscose rayon, acrylic, and modacrylic, and natural rubber latex. Based 
on staff's review of the TERA report as discussed in section C. of the 
preamble, the Commission is proposing determinations that there is a 
high degree of assurance that these unfinished manufactured fibers will 
not contain the ASTM F963 elements in concentrations greater than their 
specified limits. We note that based on staff's review of the Task 17 
report we are not proposing a determination that polyester (PET) fiber 
does not contain any of the ASTM F963 elements in concentrations 
greater than their specified solubility limits due to findings in the 
contractor report regarding the use of antimony compounds in polyester 
manufacturing.
    The Commission is also proposing determinations for seven 
unfinished manufactured fibers for the specified phthalates 
prohibitions: Polyester (PET), nylon, polyurethane (spandex), viscose 
rayon, acrylic, and modacrylic, and natural rubber latex. Based on 
staff's review of the TERA report as discussed in section C. of the 
preamble, the Commission is proposing determinations that there is a 
high degree of assurance that these unfinished manufactured fibers will 
not contain the prohibited phthalates in concentrations greater than 
their specified limits.
    These determinations would mean that, for the specified unfinished 
manufactured fibers, third party testing is not required to assure 
compliance with sections 106 and 108 of the CPSIA and 16 CFR part 1307. 
The Commission proposes to make these determinations to reduce the 
third party testing burden on children's product certifiers while 
continuing to assure compliance.

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. Section 14 of the CPSA, 
which was amended by the CPSIA, requires

[[Page 54059]]

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 
propose a rule determining that certain unfinished manufactured fibers 
do not contain the ASTM F963 elements and the specified prohibited 
phthalates in concentrations greater than their specified limits, and 
thus, are not required to be third party tested to assure compliance 
with sections106 and 108 of the CPSIA and 16 CFR part 1307.
    The proposed determinations would relieve manufacturers using the 
specified unfinished manufactured fibers from the third party testing 
requirements of section 14 of the CPSA for purposes of supporting the 
required certification. However, the proposed determinations would not 
be applicable to any other manufactured fibers beyond those listed in 
the proposed rule. The proposed determinations would only relieve the 
manufacturers' obligation to have the specified unfinished manufactured 
fibers tested by a CPSC-accepted third party conformity assessment 
body. Children's toys and child care articles must still comply with 
the substantive content limits in sections 106 and 108 of the CPSIA and 
16 CFR part 1307 regardless of any relief on third party testing 
requirements.

3. Description of the Proposed Rule

    This proposed rule would create a new Part 1253 for ``Children's 
toys and Child Care Articles: Determinations Regarding the ASTM F963 
Elements and Phthalates for Unfinished Manufactured Fibers.'' The 
proposed rule would determine that the specified unfinished 
manufactured fibers do not contain any of the ASTM F963 elements in 
excess of specified concentrations, and any of the phthalates (DEHP, 
DBP, BBP, DINP, DIBP, DPENP, DHEXP, and DCHP) prohibited by statute or 
regulation in concentrations greater than 0.1 percent.
    Section 1253.1(a) of the proposed rule explains the statutorily-
created requirements for limiting the ASTM F963 elements in children's 
toys under the CPSIA and the third party testing requirements for 
children's toys.
    Section 1253.1(b) of the proposed rule explains the statutory and 
regulatory requirements limiting phthalates for children's toys and 
child care articles under the CPSIA and the third party testing 
requirements for children's toys and child care articles.
    Section 1253.2(a) of the proposed rule would provide a definition 
of the term unfinished manufactured fiber that would apply to part 
1253.
    Section 1253.2(b) of the proposed rule would establish the 
Commission's determinations that specified unfinished manufactured 
fibers do not exceed the solubility limits for ASTM F963 elements with 
a high degree of assurance as that term is defined in 16 CFR part 1107.
    Section 1253.2(c) of the proposed rule would establish the 
Commission's determinations that specified unfinished manufactured 
fibers do not exceed the phthalates content limits with a high degree 
of assurance as that term is defined in 16 CFR part 1107.
    Section 1253.2(d) of the proposed rule states that accessible 
component parts of children's toys and child care articles made with 
the specified unfinished manufactured fibers specifically listed in the 
determinations in proposed Sec.  1253.3(b) and (c) are not required to 
be third party tested pursuant to section 14(a)(2) of the CPSA and 16 
CFR part 1107.
    Section 1253.2(e) of the proposed rule states that accessible 
component parts of children's toys and child care articles that are not 
specifically listed in the determinations in proposed Sec.  1253.3(b) 
and (c) are required to be third party tested pursuant to section 
14(a)(2) of the CPSA and 16 CFR part 1107.

4. Requested Comments on the Proposed Rule

    The Commission seeks comments on all aspects of the proposed rule. 
In particular, comments on the following topics are welcome.
     Are there any data or examples that indicate that the 
manufactured fibers identified in the proposed rule can and do contain 
the ASTM F963 elements (besides the identified use of antimony in PET) 
or prohibited phthalates at levels that are not compliant in an 
unfinished state? Please provide data supporting your assertion.
     The TERA Task 17 Report identified the use of antimony, an 
ASTM F963 element, as a catalyst used to manufacture PET. Although TERA 
looked for the presence and total concentration of antimony, the ASTM 
F963-17 requirement is for the concentration that migrates out of the 
subject material. Please provide any information that supports or 
refutes the claim that antimony will not be present in concentrations 
greater than the specified limits in PET fiber in an unfinished state 
without colorants. Please provide any information that antimony will 
not migrate out of polyester in concentrations greater than the 
specified limits in PET fiber in an unfinished state with no colorants.
     Are there any data or examples that the colorants or other 
finishes used for the manufactured fibers identified in the proposed 
rule never contain the ASTM F963 elements or prohibited phthalates at 
levels that are not compliant? Please provide data supporting your 
assertion. These data may be by type of dye, a specific dye, by fiber 
type, or some other relevant grouping.
     Are there any data or examples that the use of recycled 
content in the manufactured fibers identified in the proposed rule 
never contain the ASTM F963 elements or prohibited phthalates at levels 
that are not compliant? Please provide data supporting your assertion. 
These data may be by fiber type, product type, or some other relevant 
grouping.
     In addition to the manufactured fibers within scope of 
this study, are there other manufactured fibers widely used in 
children's toys and childcare articles that have not been identified in 
the proposed rule that do not, and will not contain the ASTM F963 
elements or prohibited phthalates? Please provide supporting data to 
show that these manufactured fibers do not and will not contain the 
ASTM F963 elements or prohibited phthalates in concentrations above the 
mandatory limits?

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). Because the proposed rule would 
provide relief from existing testing requirements under the CPSIA, the 
Commission proposes a 30 day effective date for the final rule.

F. Regulatory Flexibility Act

1. Introduction

    The Regulatory Flexibility Act (RFA) requires that agencies review 
a proposed rule for the rule's potential economic impact on small 
entities, including small businesses. Section 603 of the RFA generally 
requires that agencies prepare an initial regulatory flexibility 
analysis (IRFA) and make the analysis available to the public for 
comment when the agency is required to publish a notice of proposed 
rulemaking, unless the agency certifies that the proposed rule will not 
have a significant

[[Page 54060]]

economic impact on a substantial number of small entities. The IRFA 
must describe the impact of the proposed rule on small entities and 
identify any alternatives which accomplish the statutory objectives and 
may reduce the significant economic impact of the proposed rule on 
small entities. We provide a summary of the IRFA.

2. Small Entities to Which the Proposed Rule Would Apply

    The proposed rule would apply to small entities that manufacture or 
import children's toys and child care articles that contain the 
specified manufactured fibers. The chemical elements in the ASTM F963 
toy safety standard and the specified phthalates apply to the 
particular children's products specified in the respective 
requirements. The phthalates prohibitions apply to children's toys and 
child care articles. Regarding the specified manufactured fibers (or 
yarns or fabrics) in the children's toy category, products potentially 
affected by a Commission determination about phthalate content may 
include coverings or fill of stuffed, plush, or other soft toys, doll 
clothes, puzzle mats or other play mats, and other similar toys. Under 
the child care article category, products potentially affected by a 
Commission determination about phthalate content may include sleepwear, 
bibs, and other products that facilitate sleeping or feeding. The 
chemical requirements in the ASTM F963 toy safety standard cover 
accessible substrates of toys that can be sucked, mouthed, or ingested. 
The specified manufactured fibers (or yarns or fabrics) could be used 
in coverings or fill of stuffed, plush, or other soft toys, doll 
clothes, puzzle mats or other play mats, and other similar toys.
    The rule would apply to small entities that manufacture or import 
children's toys or child care articles that contain accessible 
polyester (PET), nylon, natural latex rubber, polyurethane (spandex), 
rayon, acrylic, and modacrylic component parts. Toy manufacturers are 
classified in North American Industry Classification System (NAICS) 
category 339930 (Doll, Toy, and Game Manufacturing). According to the 
U.S. Bureau of the Census, in 2015 there were 566 toy manufacturers in 
the United States, of which 562 had fewer than 500 employees and would 
be considered small entities according to the SBA criteria.\7\ Of the 
small manufacturers, 347 had fewer than five employees.
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    \7\ U.S. Bureau of the Census, ``Number of Firms, Number of 
Establishments, Employment, and Annual Payroll by Enterprise 
Employment Size for the United States, All Industries: 2015,'' 
County Business Patterns. Available at: https://www2.census.gov/programs-surveys/susb/tables/2015/us_6digitnaics_2015.xlsx.
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    Toy importers may be either wholesale merchants or retailers. The 
proposed rule would not apply to toy wholesalers or retailers if they 
obtain their merchandise from domestic manufacturers or importers and 
do not import toys or child care articles themselves. Toy wholesalers 
are classified in NAICS category 423920 (Toy and Hobby Goods and 
Supplies Merchant Wholesalers). According to the U.S. Bureau of the 
Census, there were 2,009 firms in this category in 2015. Of these, 
1,937 had fewer than 100 employees and would be considered small 
businesses, according to SBA criteria. Toy retailers are classified in 
NAICS category 451120 (Hobby, Toy, and Game Stores). There could be 
about 4,632 toy retailers that would meet the SBA criteria to be 
considered a small entity.\8\ Although importers are responsible for 
certifying the children's products that they import, they may rely upon 
third party testing performed by their foreign suppliers for purposes 
of certification. We do not know the number of small toy wholesalers or 
retailers that import toys, as opposed to obtaining their product from 
domestic sources. We also do not know the number of small importers 
that must obtain or pay for the third party testing of their products.
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    \8\ The SBA considers a toy retailer (NAICS 451120) to be a 
small entity if its annual sales are less than $27.5 million. 
According to the U.S. Bureau of the Census, in 2012, the average 
receipts for toy manufacturers with more than 500 employees was 
almost $900 million. The average receipts for the next largest 
category for which summary data were published, toy retailers with 
at least 100 but fewer than 500 employees, was about $10 million. 
There were 4,647 firms in this NAICS category, of which 4,632 had 
fewer than 500 employees. (U.S. Census Bureau, Number of Firms, 
Number of Establishments, Employment, Annual Payroll, and Estimated 
Receipts by Enterprise Employment Size for the United States, All 
Industries: 2012.)
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    The phthalates regulation also applies to manufacturers and 
importers of child care articles. Child care articles include many 
types of products for which the CPSC has recently promulgated or 
proposed new or amended mandatory safety standards. Under the child 
care article category, products potentially affected by a Commission 
determination about phthalate content of unfinished manufactured fibers 
may include bedside sleepers, sleepwear, bibs, and other products that 
facilitate sleep or feeding. Several types of these child care products 
likely use the types of manufactured fibers that are addressed by the 
proposed rule. In its recent market research, CPSC staff identified 364 
suppliers of these products that would be considered small according to 
criteria established by the SBA.\9\ Additionally, there could be other 
child care articles, not listed above, for which CPSC has not yet 
developed a mandatory or proposed standard, but which nevertheless are 
covered by the phthalate requirements.
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    \9\ Krishnan, Charu S., Memorandum: Determinations that Certain 
Plastics Will Not Contain Specified Phthalates: Regulatory 
Flexibility Analysis, Directorate for Economic Analysis, CPSC. June 
26, 2017.
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    Although the number of small businesses that supply children's toys 
or child care articles to the U.S. market might be close to 10,000, we 
do not know the number that actually supply products with the 
unfinished manufactured fibers in accessible component parts. We also 
do not know the number of children's toys and child care articles that 
contain these fibers. Nevertheless, based on the number of domestic toy 
manufacturers that are classified as small businesses (according to SBA 
size standards and data provided by the U.S. Bureau of the Census) and 
evidence that the specified fibers could be used extensively in toys 
and child care articles, we believe a substantial number of small 
entities would be positively impacted by the proposed rule.

3. Reporting, Recordkeeping, and Other Compliance Requirements and 
Impact on Small Businesses

    The proposed rule would not impose any reporting, recordkeeping, or 
other compliance requirements on small entities. In fact, the proposed 
rule would eliminate a requirement that third party testing be done, 
resulting in a small reduction in some of the recordkeeping burden 
under 16 CFR parts 1107 and 1109 because manufacturers would no longer 
have to maintain records of third party tests for the component parts 
manufactured from the specified unfinished manufactured fibers.
    The impact of the determinations on small businesses would be to 
reduce the burden of third party testing for the ASTM F963 elements and 
the specified phthalates, and would be expected to be entirely 
beneficial. Based on published invoices and price lists, the cost of a 
third-party test for the ASTM F963 elements ranges from around $60 in 
China, up to around $190 in the United States using Inductively Coupled

[[Page 54061]]

Plasma (ICP) testing. This cost can be greatly reduced with the use of 
high definition X-Ray fluorescence spectrometry (HDXRF), which is an 
acceptable method for certification of third party testing for the 
presence of the ASTM elements. The cost can be reduced to about $40 per 
component.
    The cost of phthalate testing is relatively high: Between about 
$125 and $350 per component, depending upon where the testing is 
conducted and any discounts that are applicable. Because one product 
might have multiple components that require testing, the cost of 
testing a single product for phthalates could exceed $1,000.
    Moreover, more than one sample might have to be tested to provide a 
high degree of assurance of compliance with the requirements for 
testing. To the extent that small businesses have lower production or 
sales volumes than larger businesses, these determinations would be 
expected to have a disproportionately beneficial impact on small 
businesses. This beneficial impact is due to spreading the costs of the 
testing over fewer units; and the benefit of the Commission making the 
determinations would be greater on a per unit basis for small 
businesses. Additionally, some testing laboratories may offer their 
larger customers discounts that might not be available to small 
businesses that need fewer third-party tests. Making the determinations 
for these manufactured fibers could significantly benefit a substantial 
number of firms.
    However, it is possible that the benefit of making the 
determinations could be less than staff expects. Although the 
manufactured fibers are widely used, the determinations are limited to 
unfinished fibers, which might be less widely used. Additionally, some 
firms might have been able to substantially reduce their third party 
testing costs by using component part testing as allowed by 16 CFR 
1109, so the marginal benefit to manufacturers from making the 
determinations might be low. Also, some firms have reduced their 
testing costs by using XRF or HDXRF technology, which is less expensive 
than ICP, and would reduce the marginal benefit of these 
determinations. Finally, some firms, particularly importers, might not 
know the specific fibers used in the products they import or whether 
fibers are unfinished and might opt to conduct the testing anyway to 
ensure that the products do not violate the requirements.
    In summary, although there are a substantial number of small 
entities that manufacture or import children's toys and childcare 
articles in which manufactured fibers could be used, we do not have 
data on the number or the extent to which unfinished manufactured 
fibers are used in these products. Therefore, we cannot determine 
whether the reduced burden would be significant for a substantial 
number of the small entities. We welcome public comments on the 
potential impact of the proposed rule on small entities. Comments are 
especially welcome on the following topics:
     The extent to which the specified unfinished manufactured 
fibers are used in children's toys, and child care articles, especially 
those manufactured or imported by small firms;
     The potential reduction in third party testing costs that 
might be provided by the Commission making the determinations, 
including the extent to which component part testing is already being 
used and the current cost of testing components made from these 
unfinished manufactured fibers for compliance with the ASTM elements 
and phthalate requirements;
     Any situations or conditions in the proposed rule that 
would make it difficult to use the determinations to reduce third party 
testing costs; and
     Although the CPSC staff expects that the impact of the 
proposed rule will be entirely beneficial, any potential negative 
impacts of the proposed rule.

4. Alternatives Considered To Reduce the Burden on Small Entities

    Under section 603(c) of the RFA, an initial regulatory flexibility 
analysis should ``contain a description of any significant alternatives 
to the proposed rule which accomplish the stated objectives of the 
applicable statutes and which minimize any significant impact of the 
proposed rule on small entities.'' Because the proposed rule is 
intended to reduce the cost of third party testing on small businesses 
and will not impose any additional burden, the Commission did not 
consider alternatives to the proposed rule that would reduce the burden 
of this rule on small businesses.

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 1253

    Business and industry, Consumer protection, Imports, Infants and 
children, Product testing and certification, Toys.

    For the reasons stated in the preamble, the Commission proposes to 
amend title 16 of the CFR to add part 1253 to read as follows:

PART 1253--CHILDREN'S TOYS AND CHILD CARE ARTICLES: DETERMINATIONS 
REGARDING THE ASTM F963 ELEMENTS AND PHTHALATES FOR UNFINISHED 
MANUFACTURED FIBERS

Sec.
1253.1 Children's toys and child care articles containing the ASTM 
F963 elements and phthalates in manufactured fibers and testing 
requirements.
1253.2 Determinations for unfinished manufactured fibers.

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


Sec.  1253.1  Children's toys and child care articles containing the 
ASTM F963 elements and phthalates in manufactured fibers and testing 
requirements.

    (a) Section 106 of the CPSIA made the provisions of ASTM F963, 
Consumer Product Safety Specifications for Toy Safety, a mandatory 
consumer product safety standard. 16 CFR part 1250 codified these 
provisions by incorporating by reference ASTM F963, see 16 CFR1250.1. 
Among the mandated provisions is section 4.3.5 of ASTM F963, which 
requires that surface coating materials and accessible substrates of 
children's toys that can be sucked, mouthed, or ingested, must comply 
with solubility limits that the toy standard establishes for eight 
elements. Materials used in children's toys subject to section 4.3.5 of 
the toy standard must comply with the third party testing requirements 
of section 14(a)(2) of the CPSA, unless listed in Sec.  1253.2.
    (b) 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-
ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl 
phthalate (BBP). In accordance with section 108(b)(3) of the CPSIA, 16 
CFR part 1307 prohibits any children's toy or child care article that 
contains concentrations of more than 0.1 percent of diisononyl 
phthalate

[[Page 54062]]

(DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-
n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate (DCHP). Materials 
used in children's toys and child care articles subject to section 
108(a) of the CPSIA and 16 CFR part 1307 must comply with the third 
party testing requirements of section 14(a)(2) of the Consumer Product 
Safety Act (CPSA), unless listed in Sec.  1253.2.


Sec.  1253.2  Determinations for unfinished manufactured fibers.

    (a) The following definition for an unfinished manufactured fiber 
applies for this part 1253. An unfinished manufactured fiber is one 
that has no chemical additives beyond those required to manufacture the 
fiber. For unfinished manufactured fibers as defined in this rule, the 
unfinished manufactured fiber is free of any chemical additives added 
to impart color or some desirable performance property, such as flame 
retardancy.
    (b) The following unfinished manufactured fibers do not exceed the 
ASTM F963 elements solubility limits set forth in 16 CFR part 1250 with 
a high degree of assurance as that term is defined in 16 CFR part 1107:
    (1) Nylon;
    (2) Polyurethane (Spandex);
    (3) Viscose Rayon;
    (4) Acrylic and Modacrylic; and
    (5) Natural Rubber Latex.
    (c) The following unfinished manufactured fibers do not exceed the 
phthalates content limits set forth in 16 CFR part 1307 with a high 
degree of assurance as that term is defined in 16 CFR part 1107:
    (1) Polyester (polyethylene terephthalate, PET);
    (2) Nylon;
    (3) Polyurethane (Spandex);
    (4) Viscose Rayon;
    (5) Acrylic and Modacrylic; and
    (6) Natural Rubber Latex.
    (d) Accessible component parts of children's toys and child care 
articles made with the unfinished manufactured fibers, listed in 
paragraphs (b) and (c) 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.
    (e) Accessible component parts of children's toys and child care 
articles made with manufactured fibers not listed in paragraphs (b) and 
(c) of this section are required to be third party tested pursuant to 
section 14(a)(2) of the CPSA and 16 CFR part 1107.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2019-21517 Filed 10-8-19; 8:45 am]
 BILLING CODE 6355-01-P