[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Rules and Regulations]
[Pages 33015-33020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09991]


=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Consumer Product Safety Commission (CPSC) is issuing a 
final rule determining that certain unfinished manufactured fibers do 
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 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: The rule is effective on July 1, 2020.

FOR FURTHER INFORMATION CONTACT: Stephen W. Lee, Compliance Officer, 
Office of Compliance and Field Operations, U.S. Consumer Product Safety 
Commission, 4330 East West Highway, Bethesda, MD 20814-4408: telephone 
301-504-7814; 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. The Commission determines that 
such materials will comply with CPSC's requirements with a high degree 
of assurance. Therefore, manufacturers do not need to have those 
materials tested by a third party testing laboratory in order 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 at 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.
---------------------------------------------------------------------------

    \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 incorporating ASTM F963 by reference 
into part 1253.
---------------------------------------------------------------------------

    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.''
---------------------------------------------------------------------------

    \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.

[[Page 33016]]



  Table 1--Maximum Soluble Migrated Element in ppm (mg/kg) for Surface
            Coatings and Substrates Included as Part of a Toy
------------------------------------------------------------------------
                                                            Solubility
                        Elements                           Limit, (ppm)
                                                                \4\
------------------------------------------------------------------------
Antimony (Sb)...........................................              60
Arsenic (As)............................................              25
Barium (Ba).............................................            1000
Cadmium (Cd)............................................              75
Chromium (Cr)...........................................              60
Lead (Pb)...............................................              90
Mercury (Hg)............................................              60
Selenium (Se)...........................................             500
------------------------------------------------------------------------

    The \4\ 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.
---------------------------------------------------------------------------

    \4\ The method to assess the solubility of a listed element is 
detailed in section 8.3, Test Methods for Determination of Heavy 
Element Content in Toys, Toy Components, and Materials, of ASTM 
F963.
---------------------------------------------------------------------------

    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 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.

4. Notice of Proposed Rulemaking

    On October 9, 2019, the Commission published a notice of proposed 
rulemaking (NPR) in the Federal Register for the unfinished 
manufactured fibers determinations. (84 FR 54055). The Commission 
proposed that certain unfinished \5\ manufactured fibers do not contain 
any of the specified ASTM F963 elements in excess of specified 
concentrations and any of the specified phthalates in concentrations 
greater than 0.1 percent (1000 ppm). Thus, accessible component parts 
made from such manufactured fibers in children's toys and child care 
articles subject to sections 106 and 108 of the Consumer Product Safety 
Improvement Act of 2008 (CPSIA) and 16 CFR part 1307 that are made with 
these manufactured fibers would not require third party testing for 
certification purposes.\6\ The comments to the NPR are addressed in 
section C of this preamble.
---------------------------------------------------------------------------

    \5\ An unfinished fiber is one that has no chemical additives 
beyond those required to manufacture the fiber. Manufactured fibers, 
unlike naturally occurring fibers, could have chemicals added before 
fiber formation to impart color or some desirable performance 
property, such as flame retardancy. For unfinished fibers as 
described in this rule, the unfinished fiber is free of these 
chemical additives.
    \6\ The Commission has previously determined that certain 
products and materials do not contain lead at levels that exceed the 
limits for lead established under section 101 of the CPSIA. These 
lead determinations include textiles consisting of natural and 
manufactured fibers (dyed or undyed). 16 C.F.R Sec.  1500.91.
---------------------------------------------------------------------------

B. Contractor's Research

1. TERA Task 17 Contractor's Report

    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 \7\ 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).\8\ TERA's Task 17 report formed the basis for 
the unfinished manufactured fiber determinations.\9\
---------------------------------------------------------------------------

    \7\ 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).
    \8\ 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.
    \9\ The staff briefing package for the NPR contains detailed 
information on theTask 17 report and staff analysis of the report. 
https://www.cpsc.gov/s3fs-public/Draft%20NPR-%20Children%27s%20Toys%20and%20Child%20Care%20Articles-%20Determinations%20Regar....pdf?IB4eKjJ_meZH1vdT5uQeojG8FfYGeqD9.
---------------------------------------------------------------------------

    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

[[Page 33017]]

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.

2. CPSC Staff Analysis of TERA Task 17 Report

    As described in the preamble of the NPR, 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 manufactured fibers within scope of the TERA report included 
the following generic fiber types: Polyester (polyethylene 
terephthalate (PET)), nylon, natural latex rubber, polyurethane 
(spandex), rayon, acrylic, and modacrylic. The TERA report found 
concentrations of antimony exceeding specified limits are used in the 
manufacture of undyed and unfinished PET. However, staff does not know 
the soluble concentration when tested according to ASTM F963. PET fiber 
is widely used in consumer textile products, including children's toys.
    In staff's review of the source material, staff did not find any 
information or data suggesting intentional use of any of the other 
chemicals of interest or presence of contaminants in fibers at 
significant levels, with reported contaminant levels no higher than a 
few parts per million. Staff believes that contaminants or impurities 
are unintentional (i.e., not added by the manufacturer intentionally), 
existing in the environment at trace levels, or present in general 
industrial practices and conditions. We conclude that any impurities 
will be at levels below the relevant limits.
Dyed or Finished Fibers (or Fibers With Chemical Additives Pre-Fiber 
Formation)
    Colorants, such as dyes, often contain metals in their structure. 
The contractor reported 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 specified in ASTM F963 without more 
information. Furthermore, the contractor reported that some of the 
specified phthalates could be used as dye auxiliaries or carriers for 
pigments. Although some of the findings may have been with products 
potentially out of the scope of the subject rule, the mechanism by 
which colorants are applied to fibers could extend to relevant 
products.
    Finishes may also be added at the fiber (yarn or fabric) stage to 
impart desirable characteristics. The contractor report cited the 
potential use of antimony-containing flame retardants and noted that 
other chemicals of interest could be used in finished fiber (yarn or 
fabric). However, those finishes were not within the scope of the 
contractor report. Staff notes that the restriction in the ASTM F963 
standard is based on solubility (excluding lead, which has separate 
specific restrictions under the CPSIA); i.e., migration of the elements 
from the product or material.

C. Discussion of Comments to the NPR

    The CPSC received one comment in response to the NPR. The 
commenter, who works with small batch manufacturers, urged approval of 
the proposed rule. The commenter did not provide data or specific 
comments or suggestions on the proposed rule.

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 also 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 section Sec.  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 intentional 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 below 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 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 
determinations in the rule 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

[[Page 33018]]

party testing is not required, a certifier must still issue a 
certificate of compliance.
    For ASTM F963 elements, determinations are made for six unfinished 
manufactured fibers: 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 B of the preamble, 
the Commission finds that there is a high degree of assurance that 
these unfinished manufactured fibers will not contain the ASTM F963 
elements in concentrations greater than the specified limits. We note 
that based on staff's review of the Task 17 report, a determination 
that polyester (PET) fiber does not contain any of the ASTM F963 
elements in concentrations greater than their specified solubility 
limits is not warranted due to findings in the contractor report 
regarding the use of antimony compounds in polyester manufacturing.
    The Commission also finds that 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 are warranted. Based on 
staff's review of the TERA report as discussed in section B. of the 
preamble, the Commission finds that there is a high degree of assurance 
that these unfinished manufactured fibers will not contain the 
prohibited phthalates in concentrations greater than the specified 
limits.
    These determinations 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 is making 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(a)(2) 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 
certain unfinished manufactured fibers do not contain the ASTM F963 
elements and the specified prohibited phthalates in concentrations 
greater than the 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 determinations in the rule relieve manufacturers who use 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 determinations are not applicable 
to any other manufactured fibers beyond those listed in the rule. The 
determinations only relieve the manufacturers of the 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 Rule

    This rule creates 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 text of the rule 
is being finalized unchanged from the proposed text in the NPR. The 
rule determines 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 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 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 rule provides a definition of the 
term ``unfinished manufactured fiber'' that applies to part 1253.
     Section 1253.2(b) of the rule establishes 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 rule establishes 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 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 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 rule states that accessible 
component parts of children's toys and child care articles that are not 
specifically listed in the determinations in 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.

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 final rule provides 
relief from existing testing requirements under the CPSIA, the 
Commission concludes a 30 day effective date is sufficient. This is the 
same effective date proposed in the NPR. Thus, the effective date is 
July 1, 2020.

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 that may be found in Tab 
A of the staff briefing

[[Page 33019]]

package.\10\ The staff FRFA is summarized below.
---------------------------------------------------------------------------

    \10\ https://www.cpsc.gov/s3fs-public/Draft%20Final%20Rule-%20Children%27s%20Toys%20and%20Child%20Care%20Articles%20-%20Determinations%20Regarding%20ASTM%20F963%20Elements%20and%20Phthalates%20for%20Unfinished%20Manufactured%20Fibers.pdf?LFcbYLvpcSdVanRkTUp.jI4.mEcY05GA.
---------------------------------------------------------------------------

    CPSC staff's review shows that comprehensive estimates of the 
number of children's toys and child care articles that contain 
component parts made from the specified unfinished manufactured fibers 
are not available. However, based on the number of domestic producers 
and sellers of these products, staff believes that a substantial number 
of small entities could be impacted by this regulation. Staff's review 
indicates that there be might be close to 10,000 small firms that 
supply children's toy or child care articles with unfinished 
manufactured fibers in accessible component parts. However, staff does 
not know the number of small firms that actually supply products with 
the unfinished manufactured fibers in accessible component parts, or 
the number of children's toys and child care article. 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, even 
if only a small proportion of these firms manufacture or sell products 
using the unfinished manufactured fibers of interest, we find that a 
substantial number would benefit from the reduced testing burden. The 
impact of the determinations on small businesses would be to reduce the 
burden of third party testing for firms and are expected to be entirely 
beneficial. The current cost of testing, on a per-test basis, is 
reflective of the expected cost reductions that would result from the 
determinations, and are as follows:
     ASTM F963 Elements--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 plasma atomic emission spectroscopy (ICP-AES). 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 part.
     Phthalates--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 in 
some cases.
    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 lower sales 
volume 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. However, small entities that need fewer third party 
tests may not qualify for discounts that some laboratories may offer 
their larger customers. In addition, the possible benefits associated 
with the determinations might be somewhat lower to the extent that 
firms were already taking advantage of component part testing as 
allowed by 16 CFR part 1109. Additionally, some firms have reduced 
their testing costs by using XRF or HDXRF technology, which is less 
expensive than ICP-AES, 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 requirements.
    The determinations would not impose any new reporting, 
recordkeeping, or other compliance requirements on small entities. In 
fact, because the rule would eliminate a testing requirement, there 
would be 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 these unfinished manufactured fibers the ASTM F963 
elements or the specified phthalates.
    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. Consequently, although the rule 
could potentially have a significant positive impact on a substantial 
number of small entities, we cannot make this determination 
categorically. Although public comments on the potential impact of the 
proposed rule on small entities were solicited, just one comment was 
received in response to the proposal. While that comment supported the 
adoption of the rule as a means to reduce the burden of third-party 
testing on small batch toy producers, specific estimates of the 
benefits to small businesses were not provided. Based on staff's 
review, the Commission finds that that the burden reduction from this 
rule could potentially result in significant benefits for a substantial 
number of manufacturers, importers, or retailers of the relevant 
product categories.
    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 being issued toreduce third party testing costs consistent with 
assuring compliance with all applicable consumer product safety rules. 
Therefore, because the rule is intended to reduce the cost of third-
party testing on small businesses and will not impose any additional 
burden on small businesses, the staff did not consider alternatives to 
the rule. We note, the Commission did not receive any comments or other 
information on any additional manufactured fibers for further burden-
reduction activities.

G. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement where 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.

H. The Congressional Review Act

    The Congressional Review Act (CRA; 5 U.S.C. 801-808) states that, 
before a rule may take effect, the agency issuing the rule must submit 
the rule, and certain related information, to each House of Congress 
and the Comptroller General. 5 U.S.C. 801(a)(1). The submission must 
indicate whether the rule is a ``major rule.'' The CRA states that the 
Office of Information and Regulatory Affairs (OIRA) determines

[[Page 33020]]

whether a rule qualifies as a ``major rule.'' Pursuant to the CRA, this 
rule does not qualify as a ``major rule,'' as defined in 5 U.S.C. 
804(2). To comply with the CRA, the Office of the General Counsel will 
submit the required information to each House of Congress and the 
Comptroller General.

List of Subjects in 16 CFR Part 1253

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

0
For the reasons stated in the preamble, the Commission amends title 16 
of the CFR by adding 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 most 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 (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. 2020-09991 Filed 5-29-20; 8:45 am]
 BILLING CODE 6355-01-P