Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics, 54754-54762 [2016-19464]
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54754
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Proposed Rules
information associated with the Class C
airspace surface area and shelf.
Lastly, this action would update the
El Paso International Airport geographic
coordinates to reflect the current ARP
information in the FAA’s aeronautical
database from ‘‘lat. 31°48′24″ N., long.
106°22′40″ W.’’ to ‘‘lat. 31°48′26″ N.,
long. 106°22′35″ W.’’
Class C airspace areas are published
in paragraph 4000 of FAA Order
7400.9Z, dated August 6, 2015 and
effective September 15, 2015, which is
incorporated by reference in 14 CFR
71.1. The Class C airspace area
modification proposed in this document
would be published subsequently in the
Order.
Regulatory Notices and Analyses
The FAA has determined that this
proposed regulation only involves an
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current. It,
therefore: (1) Is not a ‘‘significant
regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant
rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
certified that this proposed rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Paragraph 4000—Subpart C—Class C
Airspace
*
*
*
*
*
ASW TX C El Paso International Airport,
TX [Amended]
El Paso International Airport, TX
(Lat. 31°48′26″ N., long. 106°22′35″ W.)
That airspace extending upward from the
surface to and including 8,000 feet MSL
within a 5-mile radius of the El Paso
International Airport, excluding that airspace
west of long. 106°27′02″ W., and that airspace
within Mexico; and that airspace extending
upward from 5,200 feet MSL to and
including 8,000 feet MSL within a 10-mile
radius of the El Paso International Airport,
excluding that airspace west of long.
106°27′02″ W., and that airspace within
Mexico.
Issued in Washington, DC, on August 10,
2016.
M. Randy Willis,
Acting Manager, Airspace Policy Group.
[FR Doc. 2016–19556 Filed 8–16–16; 8:45 am]
BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1308
U.S. Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
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[Amended]
2. The incorporation by reference in
14 CFR 71.1 of the FAA Order 7400.9Z,
Airspace Designations and Reporting
Points, dated August 6, 2015, and
effective September 15, 2015, is
amended as follows:
■
Prohibition of Children’s Toys and
Child Care Articles Containing
Specified Phthalates: Determinations
Regarding Certain Plastics
This proposal will be subject to an
environmental analysis in accordance
with FAA Order 1050.1F,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
In consideration of the foregoing, the
Federal Aviation Administration
proposes to amend 14 CFR part 71 as
follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
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§ 71.1
[Docket No. CPSC–2016–0017]
Environmental Review
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Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
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The Consumer Product Safety
Commission (Commission, or CPSC) is
proposing a rule to determine that
certain plastics with specified additives
would not contain the specified
phthalates prohibited in children’s toys
and child care articles. Based on these
determinations, the specified plastics
with specified additives would not
require third party testing for
compliance with the mandatory
phthalates prohibitions on children’s
toys and child care articles.
DATES: Submit comments by October 31,
2016.
SUMMARY:
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You may submit comments,
identified by Docket No. CPSC–2016–
0017, by any of the following methods:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
The Commission does not accept
comments submitted by electronic mail
(email), except through regulations.gov.
The Commission encourages you to
submit electronic comments by using
the Federal eRulemaking Portal, as
described above.
Written Submissions: Submit written
comments by mail/hand delivery/
courier to: Office of the Secretary,
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. All comments received
may be posted without change,
including any personal identifiers,
contact information, or other personal
information provided, to: https://
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 by mail/
hand delivery/courier.
FOR FURTHER INFORMATION CONTACT:
Randy Butturini, Project Manager,
Office of Hazard Identification and
Reduction U.S. Consumer Product
Safety Commission, 4330 East West
Hwy., Room 814, Bethesda, MD 20814;
301–504–7562: email; rbutturini@
cpsc.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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
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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).
permanent, and proposing to lift the
interim statutory prohibitions on DIDP
and DnOP in children’s toys and child
care articles. In addition, the NPR
proposed adding four new phthalates to
the prohibited list of phthalates that
cannot exceed 0.1 percent concentration
in accessible component parts of
children’s’ toys and child care articles.
Table 2 contains the list of phthalates
that the NPR proposed to prohibit in
children’s toys and child care articles.
2. Prohibitions in Section 108 of the
CPSIA
Section 108 of the CPSIA prohibits
children’s toys and child care articles
that contain six specified phthalates in
concentrations above 0.1 percent in
‘‘accessible plasticized component parts
and other component parts made of
materials that may contain phthalates.’’
The prohibited phthalates in section 108
of the CPSIA are listed in Table 1.
Children’s toys and child care articles
subject to the content limits in section
108 of the CPSIA require third party
testing for compliance with the
phthalate content limits before the
manufacturer can issue a Children’s
Product Certificate (CPC) and enter the
children’s toys or child care articles into
commerce.
TABLE 2—PROPOSED PROHIBITED
PHTHALATES
TABLE 1—STATUTORILY PROHIBITED
PHTHALATES
Permanent prohibition on phthalates in
children’s toys and child care articles
DEHP: di-(2-ethylhexyl) phthalate
DBP: dibutyl phthalate
BBP: benzyl butyl phthalate
Interim prohibition on phthalates in
children’s toys and child care articles
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DINP: diisononyl phthalate
DIDP: diisodecyl phthalate
DnOP: di-n-octyl phthalate
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.’’
The CHAP issued its report in July
2014.1 Based on the CHAP report, the
Commission published a notice of
proposed rulemaking (NPR) 2 proposing
to make the interim prohibition on DINP
in children’s toys and child care articles
1 https://www.cpsc.gov/PageFiles/169902/CHAPREPORT-With-Appendices.pdf.
2 https://www.federalregister.gov/articles/2014/
12/30/2014-29967/prohibition-of-childrens-toysand-child-care-articles-containing-specifiedphthalates.
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Phthalates
DEHP: di-(2-ethylhexyl) phthalate
DBP: dibutyl phthalate
BBP: benzyl butyl phthalate
DINP: diisononyl phthalate
DIBP: diisobutyl phthalate
DPENP: di-n-pentyl phthalate
DHEXP: di-n-hexyl phthalate
DCHP: dicyclohexyl phthalate
B. Contractor’s Research on Phthalates
in Consumer Products
CPSC contracted with Toxicology
Excellence for Risk Assessment (TERA)
to conduct research on phthalates and
provide CPSC with two research reports
on phthalates relevant to this
rulemaking. TERA conducted a
literature search on the production and
use of 11 specified phthalates in
consumer products (Task 11 Report).3
The 11 phthalates researched by TERA
are based on the phthalates assessed by
the CHAP and the recommendations
made in the CHAP report. Additionally,
the CPSC contracted with TERA to
conduct a literature search on whether
specified plastics could be determined
not to contain any of the 11 phthalates
in concentrations above the CPSIA limit
of 0.1 percent (Task 12 Report).4
TERA used a tiered literature research
approach to identify sources for review
from among the ‘‘universe’’ of available
data. The tiers were used to provide a
structured search method to locate
relevant sources and eliminate
unrelated material. TERA used books,
factsheets, journal articles, patents, and
other sources as primary and secondary
literature sources. The use of this tiered
3 https://www.cpsc.gov//Global/Research-andStatistics/Technical-Reports/
Other%20Technical%20Reports/
TERAReportPhthalates.pdf. The work was
conducted as a task order (Task 11) under CPSC
contract CPSC–D–12–0001.
4 https://www.cpsc.gov//Global/Research-andStatistics/Technical-Reports/
Other%20Technical%20Reports/
ReportonPhthalatesinFourPlastics.pdf. The work
was conducted as a task order (Task 12) under
CPSC contract CPSC–D–12–0001.
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approach resulted in a comprehensive
review of the available literature that is
representative of the information
available on the potential for the
presence of any of the 11 phthalates in
the 4 specified plastics.
TERA screened over 119,800 studies
identified by the above described tiered
search method for relevance to the 11
phthalates and 4 plastics. CPSC staff
reviewed the information provided in
the contractor report and formulated
recommendations for Commission
consideration based on TERA’s
research.
The plastics researched by TERA
were:
• Polypropylene (PP);
• Polyethylene (PE);
• High-impact polystyrene (HIPS);
and
• Acrylonitrile butadiene styrene
(ABS).
TERA’s research included the
following factors:
• The raw materials used in the
production of the specified plastics;
• The manufacturing processes used
worldwide to produce the plastics;
• Typical applications for the
specified plastics in consumer products,
especially toys and child care articles,
focusing on circumstances where the
plastic could contain phthalates at
concentrations greater than 0.1 percent;
• The potential use of recycled
materials containing the specified
phthalates in the production of the
plastics; and
• The potential for phthalate
contamination during packaging,
storage, use, or other factors.
C. CPSC Staff Analysis
1. Polypropylene (PP)
TERA’s research indicated the
production of PP plastic uses a PP
monomer, ethylene, and other
monomers, a hydrocarbon solvent,
catalysts, nucleating agents or fillers,
and a number of other additives,
depending on the type of PP and other
manufacturing considerations.
Additives can be included in PP to
achieve various chemical and
mechanical characteristics. PP can
include the following additives:
• Hydrocarbon solvents: Examples of
solvents used are hexane and heptane;
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• Catalysts: 5 Catalysts used in
producing PP are the Ziegler-Natta
catalysts; 6
• Fillers: Fillers are added to plastics
to enhance their performance (e.g.,
impact resistance, shrink resistance),
and reduce manufacturing costs.
Examples of fillers used in PP include
talc, calcium carbonate, and fiberglass;
• Primary antioxidants: Antioxidants
inhibit oxidative deterioration of a
material. Primary antioxidants donate
hydrogen atoms to prevent free radical
creation. Examples of primary
antioxidants include hindered phenol,
such as butylated hydroxytoluene, and
hindered amine light stabilizers;
• Secondary antioxidants: Secondary
antioxidants prevent degradation by
breaking down free radicals and
hydroperoxides, and synergize with the
primary antioxidants. Examples of
secondary antioxidants include
phosphites and thioesters;
• Neutralizing agents: Neutralizing
agents adjust the acidity of the
chemicals during production, and can
include calcium and zinc stearate,
zeolites, calcium and zinc oxides, and
metallic salts of lactic or benzoic acid;
• Antistatic agents: Antistatic agents
reduce the buildup of static electricity,
and can include cationic compounds,
anionic compounds, and nonionic
compounds;
• Slip agents: Slip agents are added to
reduce a plastic surface’s coefficient of
friction. Examples of slip agents include
modified fatty acids or fatty amides;
• Metal deactivators: Transition
metals like copper and iron can
accelerate plastic degradation. Metal
deactivators, such as N,N′dibenzaloxaldihydrazide, combine with
the metal ions and prevent catalytic
degradation of the plastic;
• Quenchers: Quenchers scavenge
stray free radicals and decompose
unwanted peroxides. Examples of
quenchers are organic nickel complexes,
nickel salts of thiocarbamate, and nickel
complexes with alkylated phenol
phosphonates;
• UV stabilizers: Ultraviolet (UV)
stabilizers are added to PP to protect the
plastic from degradation in sunlight.
Examples of UV stabilizers are hindered
amine light stabilizers, carbon black,
titanium dioxide, zinc oxide, derivatives
of benzophenone, benzotriazoles,
phenyl, aryl, or acrylic esters,
formamidines, and oxanilides;
5 The Merriam-Webster online dictionary defines
a ‘‘catalyst’’ as ‘‘a substance that causes or
accelerates a chemical reaction without itself being
affected.’’ A catalyst is not consumed, altered, or
incorporated into one of the reaction’s products.
6 A Ziegler–Natta catalyst, named after Karl
Ziegler and Giulio Natta, is a class of catalyst used
in the production of some plastics.
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• Nucleating agents: Nucleating
agents are additives that increase the
crystallization of a plastic from a liquid
solution. Examples of nucleating agents
for PP include carboxylic acids, benzyl
sorbitols, and salts of organic
phosphates;
• Flame retardants: Examples of
flame retardants include brominated
flame retardants, cycloaliphatic
chlorines; antimony trioxide, ferric
oxide, zinc oxide, zinc borate, barium
metaborates; phosphorus flame
retardants, magnesium hydroxide, and
aluminum hydroxide;
• Blowing or foaming agents: Blowing
and foaming agents create gas bubbles
during molding, resulting in a foamed
plastic. Examples of blowing and
foaming agents include sodium
bicarbonate, sodium borohydride,
polycarbonic acid, citric acid,
4,4′oxybis(benzenesulfonyl hydrazide),
azodicarbonamide, or paratoluenesulfonyl semicarbazide;
• Antiblocking agents: Antiblocking
agents are used to prevent plastic films
from sticking together through cold flow
or static electricity. Examples of
antiblocking agents include natural and
manufactured waxes, metallic salts of
fatty acids, silica compounds, and some
polymers (e.g., polyvinyl alcohol,
polyamides, polyethylene,
polysiloxanes, and fluoroplastics);
• Lubricants: Lubricants are used in
PP (and other plastics) to lower the
molten material’s coefficient of viscosity
and prevent the plastic from sticking to
metal surfaces. The lubricants allow the
plastic’s hydrocarbon chains to slip past
each other in the melt. Examples of
lubricants include metal soaps,
hydrocarbon waxes, polyethenes, amide
waxes, fatty acids, and fatty alcohols,
(e.g., calcium or zinc stearates); or
• Colorants: Colorants for plastics
typically consist of dyes, in which the
color-producing material is dissolved in
a carrier medium, and pigments, in
which very small particles of the colorproducing material are suspended in the
carrier medium. Examples of colorants
used in PP include heavy metal-based
oxides, sulfides, chromates, and other
complexes, including cadmium, zinc,
titanium, lead, molybdenum; and
ultramines (sulfide-silicate complexes
containing sodium and aluminum; azo
pigments).
The research showed that among all
of these raw materials and additives,
only Ziegler-Natta catalysts may contain
one or more of the prohibited
phthalates. Ziegler-Natta catalysts are
generally titanium-based catalyst
systems in combination with an
organoaluminum co-catalyst, and an
internal donor (a molecule that
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contributes an electron to the chemical
reaction), such as DBP, DIBP or DEHP.
As described in the Task 12 Report,
these catalysts may survive the plastic’s
polymerization process, and the
phthalates may be present in the final
plastic pellets, theoretically at
concentrations of about 1 mg/kg (1 part
per million, ‘‘ppm’’). The Task 12
Report references an industry analysis
in the context of European regulations
that indicates that phthalate
concentrations in PP do not exceed 0.15
mg/kg (0.15 ppm) and are often below
the measurement threshold of the
analytical method of 0.01 mg/kg (0.01
ppm).
2. Polyethylene (PE)
TERA’s research indicated that PE is
manufactured using PE monomers or
certain copolymers or other monomers,
and a number of additives. Additives
can be included in PE to achieve various
chemical and mechanical
characteristics. PE can include the
following additives:
• Plasticizers: 7 Examples of
plasticizers for PE include glyceryl
tribenzoate, polyethylene glycol,
sunflower oil, paraffin wax, paraffin oil,
mineral oil, glycerin, EPDM rubber,
EVA polymer, DOP; 8
• Initiators: Initiators help form the
plastic macromolecules from the
solution. Examples of PE initiators are
benzoyl peroxide, azodiisobutyronitrile, and oxygen;
• Promoters: Promoters in PE
improve paint adhesion and resistance
to some solvents. PE promoters include
sodium and calcium (in metal or
hydride form);
• Catalysts: Catalysts for PE include
the Ziegler-Natta catalysts, and
metallocene catalysts (e.g., zirconium,
titanium);
• Fillers: silane and titanate coupling
agents are used as fillers in PE;
• Antistatic agents: PE antistatic
agents include polyethylene glycol alkyl
esters;
7 The Task 12 Report indicated that several
prohibited phthalates are used as plasticizers in PE.
CPSC staff reviewed the report’s references for this
information. As cited in the Task 12 Report, Bhunia
et al. (2013) reported several phthalates used in
food packaging plastic films, including PE,
referencing Sablani and Rahman (2007). In the latter
reference, staff did not find any support for the
claimed uses of phthalates. In fact, in the section
on plasticizers, Sablani and Rahman (2007) stated
that most plasticizers are used in PVC and that as
a result of studies on migration of plasticizers from
food packaging, ‘‘. . . industry has replaced PVC
with other polymers, such as PE or regenerated
cellulose not associated with plasticizers.’’
(emphasis added)
8 The isomer of DOP was not specified. DOP can
include DEHP.
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• Flame retardants: PE flame
retardants include antimony trioxide,
and halogenated substances;
• Anti-blocking agents: Fine silicas
are an example of a PE antiblocking
agent;
• Slip agents: PE slip agents include
fatty acid amides such as oleamide and
erucamide;
• Blowing agents: PE blowing agents
include 4,4′-oxybisbenzenesulfonohydrazine and azocarbonamide;
• Cross-linking agents: Cross-linking
agents set up chemical bonds between
the plastic macromolecules and assists
in ‘‘curing’’ the plastic. Examples of
cross-linking agents include dicumyl
peroxide, and vinyl silanes;
• Antioxidants: PE antioxidants
include 4-methyl-2,6-t-butyl phenol,
1,1,3-tris-(4-hydroxy-2-methyl-5butylphenyl)butane, bis-[2-hydroxy-5methyl-3-(1-methylcyclohexyl)phenyl]methane, and dilauryl-b,b′thiodipropionate;
• Carbon black; or
• Colorants: PE colorants are often
based on cobalt, cadmium, and
manganese.
As with PP, PE catalysts include an
internal donor, such as DBP, DIBP, or
DEHP, although the phthalate
concentration in the final plastic is
generally well below 0.15 mg/kg (0.15
ppm).
One reference in the Task 12 report
indicated that DOP can be used as a
plasticizer in PE. Staff reviewed the
cited references, as well as citations
within the references, and found that
uses of DOP in PE are mentioned in
patents for specialized materials with no
known current consumer product
application, or may be used in
materials, such as pavement marking,
which are not children’s products. One
cited patent described use of phthalates
in a PE microporous film used as an
internal separator for lithium ion
batteries.
The Task 12 Report cited a patent for
a material made with PE plastic and
DBP for use as a surface for outdoor
athletic track, basketball, volleyball, and
playgrounds. CPSC staff found no
information indicating that such a
product has been manufactured and
marketed for consumer use.
Furthermore, the applications for the
material do not include children’s toys
or child care articles that are subject to
the phthalate content restrictions.
3. High-Impact Polystyrene (HIPS)
TERA’s research indicated that HIPS
is a plastic blend generally produced
from styrene, polybutadiene rubber,
benzene, and a number of other
substances. Additives can be included
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in HIPS to achieve various chemical and
mechanical characteristics. HIPS can
include the following additives:
• Catalysts: The Ziegler-Natta
catalysts;
• Internal lubricant: Zinc stearate is a
lubricant for HIPS;
• Chain transfer/transition agent:
Chain transfer/transition agents regulate
the length of the HIPS macromolecules.
HIPS chain transfer/transition agents
include tertdocecylmercaptan and
liquid paraffin;
• Stabilizer: Tert-butylcatechol is a
stabilizer for HIPS;
• Diluents: Diluents are used to
reduce the concentration of a plastic as
a means to reduce the plastic’s viscosity
and to modify its processing conditions.
Examples of HIPS diluents include
ethylbenzene, and toluene; or
• Colorants: HIPS colorants include
azo dyes, anthraquinone dyes, perinone
dyes, or xanthene dyes.
• Other additives: Additional
materials used in the manufacture of
HIPS include:
Æ Aluminum chloride, ethyl chloride,
hydrochloric acid;
Æ Iron oxide, potassium oxide,
chromium oxide; and
Æ Bifunctional peroxides.
As with PP and PE, the polybutadiene
used in HIPS production is made with
the use of catalysts that include an
internal donor, such as DBP, DIBP, or
DEHP. Although no testing for phthalate
content was located, because the use of
phthalate in HIPS is as a catalyst, the
concentration in the final product is
expected to be well below 0.1 percent.
4. Acrylonitrile Butadiene Styrene (ABS)
TERA’s research indicated that ABS
plastic is manufactured with specific
monomers, such as acrylonitrile,
butadiene, and styrene, trans-1,4butadiene, cis-1,4-butadiene, and 1,2butadiene. Additives are included in
ABS to achieve various chemical and
mechanical characteristics. ABS can
include the following additives:
• Plasticizers: ABS plasticizers
include hydrocarbon processing oil,
triphenyl phosphate, resorcinol
bis(diphenyl phosphate), oligomeric
phosphate, long chain fatty acid esters,
and aromatic sulfonamide;
• Hydrocarbon solvents: hexane,
heptane, and ethyl benzene;
• Stabilizers against heat or light
degradation: Stabilizer examples
include phenolic antioxidants, thiolcontaining antioxidants, phosphites,
thioesters, substituted benzophenones
and benzotriazoles, and hindered
amines;
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• Lubricants: ABS lubricants include
metallic stearates, montan waxes or
amide waxes; 9
• Antioxidants: Phenolic-based or
phosphate-based antioxidants are used
in the manufacture of ABS;
• Molecular weight regulator: An
example of an ABS molecular-weight
regulator is tert-dodecyl mercaptan;
• Initiators/catalysts: ABS initiators
and catalysts include potassium
persulfate, sodium persulfate, oilsoluble initiators in a redox system
(cumene hydroperoxide, sodium
pyrophosphate, dextrose, and iron (II)
sulfate);
• Activators: Activators prepare the
ABS surface for electroplating. The
activators in ABS are often palladium
and tin salts in an acid solution; 10
• Emulsifiers: Emulsifiers are
chemicals that promote the mixing of
hydrophilic and hydrophobic materials.
ABS emulsifiers include salts of rosin,
fatty sodium lauryl sulfate, and oleate;
• Colorants: ABS colorants include
phthalocyanines, perylenes,
cromophtals, titanium dioxide, carbon
black, black iron oxide, ultramarine
blue, red iron oxide, and aluminum
flake.11
5. Additional CPSC Staff Research
TERA’s research did not include an
examination of the colorants in
polyethylene, high-impact polystyrene,
or acrylonitrile butadiene styrene.
TERA’s research also did not include an
examination of the lubricants,
activators, and antioxidants that could
be used in the production of ABS. CPSC
staff conducted additional research into
these component parts of the plastics.
6. Potential Phthalate Use in the Four
Plastics
The Task 11 Report indicates that
phthalates are used generally as
plasticizers or softeners of certain
plastics, primarily polyvinyl chloride
(PVC), as solvents, and as components
of inks, paints, adhesives, and sealants.
Except for the general category of inks
and colorants, the Task 11 Report did
not indicate uses of the prohibited
phthalates in any of the four plastics, in
the raw materials, or in the types of
additives that might be used in the four
plastics.
The four plastics may also be used as
ingredients in a variety of materials. For
9 The TERA Task 12 Report did not specify ABS
lubricants. CPSC staff supplemented the Task 12
Report with additional research.
10 The TERA Task 12 Report did not specify ABS
activators. CPSC staff supplemented the Task 12
Report with additional research.
11 The TERA Task 12 Report did not specify ABS
colorants. CPSC staff supplemented the Task 12
Report with additional research.
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example, PP may be used in
formulations for concrete, paints, and
lubricating grease. These materials
would not be considered to be PP
plastic. PE, HIPS, ABS also may be used
as additives in materials that would not
be considered plastics.
The TERA Task 11 and Task 12
Reports indicate that the phthalates
researched are not associated with the
chemistry and applications of the
plastics PP, PE, HIPS, or ABS. When
these plastics are plasticized, materials
other than the phthalates are used as
plasticizers (e.g., hydrocarbon
processing oil, phosphate esters, long
chain fatty acid esters, and aromatic
sulfonamide for ABS). TERA found one
reference in which DnOP (also referred
to as DOP) was used as a plasticizer for
PE. However, the only application cited
was a patent for a microporous plastic
film used in the production of lithiumion batteries. TERA’s research included
references prior to and after the
enactment of the CPSIA, none of which
indicated any phthalate use in the four
plastics.
7. Studies Where Phthalates Were
Detected
TERA’s investigation of the uses of
the four plastics shows that all four are
used to make plastic consumer products
and component parts. None of these
applications specifically includes
phthalates, although a few studies of the
phthalate content of products were
located.
Several studies evaluated food,
beverage, and cosmetics packaging
made with PP, PE, and polystyrene (PS).
These studies generally measured
migration of specified chemicals,
including phthalates, from products
purchased in retail stores. The
references provided few or no details
about all the materials used in the
products, including whether other
plastics were present, whether other
component parts were present such as
coatings, finishes, inks, or adhesives, or
whether residues of the contained
products were present.
The Task 12 Report also cited a
Korean study of various products that
reported low levels of phthalates in a
toy car made with ABS. The study
provided no details about other
materials used in the product, including
whether other plastics were present, or
whether other component parts were
present such as coatings, finishes, inks,
or adhesives.
The Task 12 Report’s detailed
description of the raw materials and
manufacturing processes for PP, PE,
HIPS, and ABS plastics showed that
phthalates are not present after these
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plastics are produced. However, the
Task 11 Report describes uses of
phthalates in materials on these plastics,
such as coatings, inks, and adhesives.
Because consumer products purchased
in stores likely consist of a number of
different component parts, some of
which may have contained phthalates,
the studies described above should not
be considered to be evidence that
phthalates were used in the
manufacture of the PP, PE, HIPS, or ABS
plastic component parts of consumer
products subject to the phthalate
content restrictions.
8. Phthalates in Recycled Materials
All four plastics may be recycled and
reprocessed into new products.
However, degradation of the original
plastics during the recycling process
and mixing with other plastics or
materials in the recycling steam can
reduce the quality of the recovered
plastic and limit further commercial
uses. In some cases, recovered plastics
are mixed with virgin plastics to
improve the products’ quality and
utility. The Task 12 Report indicated
that few studies were located for
analysis of phthalates in recycled
plastics. One study found no phthalates
in recycled PP carpet. Two studies
analyzed solid waste consisting of PP or
PE. One study reported detection of
phthalates in recovered waste PP and PE
material, but not in samples of virgin PP
or PE plastic. The other study reported
phthalates in recovered PE. The authors
of the latter study suggested that the
source of phthalates could have been
the products that had been in contact
with the plastic.
HIPS and ABS are generally used as
rigid materials; available information
does not indicate use of phthalates in
such materials or associated with
recycled HIPS or ABS.
Some studies indicated the potential
for low, but detectable, levels of
phthalates in plastics, such as PP or PE
packaging that contained or had been in
contact with a phthalate-containing
product. Products made with such
materials could contain residual
phthalates, although at levels well
below the maximum allowed
concentration in children’s products.12
9. Staff Conclusions Based on TERA
Research
With the exception of the catalysts for
polymerization, and certain, specific
uses of phthalates in products without
consumer product applications, neither
12 The highest level recorded by Huber and Franz
was 200 ppm for one sample of DBP. The other
samples’ concentrations ranged from 3.1 to 96.3
ppm.
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of the TERA task reports, nor research
by CPSC staff found that phthalates are
used as a component part of the four
plastics. In the case of the phthalate
catalysts used in plastics manufacturing,
the phthalate concentration in finished
plastics is significantly below the
maximum allowable concentration.
The two TERA task reports and CPSC
staff research show that very little
information exists that indicates that
manufactured PP, PE, HIPS, and ABS
plastics could contain the researched
phthalates. The research located
references, including patents, for
uncommon and specialized products,
and products that generally do not have
applications to children’s toys and child
care articles.
Staff found no evidence that
phthalates are present at concentrations
above 0.1 percent in any of the four
plastics (either virgin or using recycled
material) for consumer products,
especially children’s products.
D. Determinations for Specified Plastics
1. Legal Requirements for a
Determination
As noted above, section 14(a)(2) of the
CPSA requires third party testing for
children’s products that are subject to a
children’s product safety rule. 15 U.S.C.
2063(a)(2). Children’s toys and child
care articles must comply with the
phthalates prohibitions in section 108 of
the CPSIA. 15 U.S.C. 2057c. In response
to statutory direction, the Commission
has investigated approaches that would
reduce the burden of third party testing
while also assuring compliance with
CPSC requirements. As part of that
endeavor, the Commission has
considered whether certain materials
used in children’s toys and child care
articles would not require third party
testing.
To issue a determination that a plastic
(including specified additives) does not
require third party testing, the
Commission must have sufficient
evidence to conclude that the plastic
and specified additives would
consistently comply with the CPSC
requirement to which the plastic (and
specified additives) is subject so that
third party testing is unnecessary to
provide a high degree of assurance of
compliance. Under 16 CFR part 1107
section 1107.2, ‘‘a high degree of
assurance’’ is defined as ‘‘an evidencebased demonstration of consistent
performance of a product regarding
compliance based on knowledge of a
product and its manufacture.’’
For a material determination, a high
degree of assurance of compliance
means that the material will comply
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with the specified chemical limits due
to the nature of the material or due to
a processing technique that reduces the
chemical concentration below its limit.
For materials determined to comply
with a chemical limit, the material must
continue to comply with that limit if it
is used in a children’s product subject
to that requirement. A material on
which a determination has been made
cannot be altered or adulterated to
render it noncompliant and then used in
a children’s product.
Phthalates are not naturally occurring
materials, but are intentionally created
and used in specific applications (e.g.,
plastics, surface coatings, solvents, inks,
adhesives, and some rubberized
materials). One application of
phthalates in children’s toys and child
care articles is as a plasticizer, or
softener for plastic component parts.13
The addition of a plasticizer converts an
otherwise rigid plastic into a more
flexible form, such as in a child’s rubber
duck or a soft plastic doll. Because
plastics can contain the prohibited
phthalates, third party testing is
required before a CPC can be issued for
children’s toys and child care articles
with accessible plastic component parts.
However, some specific plastics with
certain additives might not use any of
the prohibited phthalates as a
plasticizer, or for any other purpose. For
these specific plastics and
accompanying additives, compliance
with the requirements of section 108 of
the CPSIA can be assured without
requiring third party testing. As a means
to reduce the third party testing burden
on children’s product certifiers while
continuing to ensure compliance, the
CPSC is proposing to make
determinations that specified plastics
with certain additives comply with the
phthalate content requirements of
section 108 of the CPSIA based on
evidence indicating that such materials
will not contain the prohibited
phthalates.
Based on the discussion in section C
of this preamble, the Commission
proposes to determine that the specified
four plastics and accompanying
additives would comply with the
phthalates prohibitions with a high
degree of assurance. These
determinations mean that third party
testing for compliance with the
phthalates prohibitions is not required
for certification purposes for the
specified four plastics. The Commission
proposes to make these determinations
13 The Merriam-Webster online dictionary defines
a plasticizer as ‘‘a chemical added especially to
rubbers and resins to impart flexibility, workability,
or stretchability.’’
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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. As noted previously, section 14 of
the CPSA, which was amended by the
CPSIA, requires third party testing for
children’s products subject to a
children’s product safety rule. 15 U.S.C.
2063(a)(2). Section 14(d)(3)(B) of the
CPSA, as amended by Public Law 112–
28, gives the Commission the authority
to ‘‘prescribe new or revised third party
testing regulations if it determines that
such regulations will reduce third party
testing costs consistent with assuring
compliance with the applicable
consumer product safety rules, bans,
standards, and regulations.’’ Id.
2063(d)(3)(B). These statutory
provisions authorize the Commission to
issue a rule determining that specified
plastics and additives will not exceed
the phthalates prohibitions of section
108 of the CPSIA, and therefore,
specified plastics do not require third
party conformity assessment body
testing to assure compliance with the
phthalates limits in section 108 of the
CPSIA.
The proposed determinations would
relieve the four specified plastics and
accompanying additives from the third
party testing requirement of section 14
of the CPSA for purposes of supporting
the required certification. However, the
proposed determinations would not be
applicable to any other plastic or
additives beyond those listed in the
proposed rule.
The proposed determinations would
only relieve the manufacturers’
obligation to have the specified plastics
and accompanying additives tested by a
CPSC accepted third party conformity
assessment body. Children’s toys and
child care articles must still comply
with the substantive phthalates content
limits in section 108 of the CPSIA
regardless of any relief on third party
testing requirements.
3. Description of the Proposed Rule
This proposed rule would create a
new Part 1308 for ‘‘Prohibition of
Children’s Toys and Child Care Articles
Containing Specified Phthalates:
Determinations Regarding Certain
Plastics.’’ The proposed rule would
determine that the specified four
plastics and accompanying additives do
not contain the statutorily prohibited
phthalates (DEHP, DBP, BBP, DINP,
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DIDP, DnOP) in concentrations above
0.1 percent, and thus, are not required
to be third party tested to assure
compliance with section 108 of the
CPSIA. As discussed in section A.2 of
the preamble, the agency is currently
involved in rulemaking to determine
whether to continue the interim
prohibitions in section 108 and whether
to prohibit any other children’s
products containing any other
phthalates. TERA’s examination covered
all phthalates that are subject to the
current permanent and interim
prohibitions, as well as the additional
phthalates the Commission proposed
restricting in the phthalates proposed
rule. If the Commission issues a final
rule in the phthalates rulemaking before
finalizing this determinations
rulemaking, the Commission would
modify the determinations proposed
rule so that the determinations rule
covers the same phthalates restricted by
the final phthalates rule.
Section 1308.1 of the proposed rule
explains the statutorily-created
requirements for children’s toys and
child care articles under section 108 of
the CPSIA and the third party testing
requirements for children’s products.
Section 1308.2(a) of the proposed rule
would establish the Commission’s
determinations that the following
plastics do not exceed the phthalates
content limits with a high degree of
assurance as that term is defined in 16
CFR part 1107:
• Polypropylene, with any of the
following additives:
Æ the plasticizers polybutenes,
dioctyl sebacate, paraffinic oil, isooctyl
tallate, mineral plasticizing oils, and
polyol;
Æ hydrocarbon solvents;
Æ catalysts;
Æ fillers;
Æ nucleating agents;
Æ primary and secondary
antioxidants;
Æ neutralizing agents;
Æ antistatic agents;
Æ slip agents;
Æ metal deactivators;
Æ quenchers;
Æ UV stabilizers;
Æ flame retardants;
Æ blowing or foaming agents;
Æ antiblocking agents;
Æ lubricants; or
Æ colorants.
• Polyethylene, with any of the
following additives:
Æ the plasticizers glyceryl tribenzoate,
polyethylene glycol, sunflower oil,
paraffin wax, paraffin oil, mineral oil,
glycerin, EPDM rubber, and EVA
polymer;
Æ catalysts;
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Æ initiators;
Æ promoters;
Æ antistatic agents;
Æ fillers;
Æ flame retardants;
Æ anti-blocking agents;
Æ slip agents;
Æ blowing agents;
Æ cross-linking agents;
Æ antioxidants;
Æ carbon black; or
Æ colorants.
• High-impact polystyrene, with any
of the following additives:
Æ catalysts;
Æ internal lubricants;
Æ chain transfer/transition agents;
Æ stabilizers;
Æ diluents;
Æ colorants;
Æ aluminum chloride, ethyl chloride,
hydrochloric acid;
Æ iron oxide, potassium oxide,
chromium oxide; or
Æ bifunctional peroxides.
• Acrylonitrile butadiene styrene,
with any of the following additives:
Æ the plasticizers phosphate esters,
long chain fatty acid esters and aromatic
sulfonamide;
Æ hydrocarbon solvents;
Æ stabilizers;
Æ lubricants;
Æ antioxidants;
Æ molecular weight regulators;
Æ initiators/catalysts,
Æ activators;
Æ emulsifiers; or
Æ colorants.
Section C.2 of the preamble provides
a more detailed discussion of the
additives for each of the four plastics
with the specified additives including
definitions of the additives and various
examples of the types of additives.
Section 1308.2(b) of the proposed rule
states that accessible component parts of
children’s toys and child care articles
made with the specified plastics, and
specified additives listed in paragraph
(a) of that section, are not required to be
third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part
1107. Proposed § 1308.2(b) is included
in the rule to make clear that when the
listed plastics and accompanying
additives are used in children’s toys and
child care articles, manufacturers and
importers are not required to conduct
the third party testing required in
section 14(a)(2) of the CPSA and 16 CFR
part 1107. Section 1308.2(c) of the
proposed rule states that accessible
component parts of children’s toys and
child care articles made with a plastic
or additives not listed in paragraph (a)
of this section are required to be third
party tested pursuant to section 14(a)(2)
of the CPSA and 16 CFR part 1107.
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Proposed § 1308.2(c) is intended to
make clear that if a manufacturer or
importer uses any other plastic or
additive in a children’s toy or child care
article not listed in proposed
§ 1308.1(a), that children’s toy or child
care article must be third party tested
pursuant to section 14(a)(2) of the CPSA
and 16 CFR part 1107. Finally, the
determinations in proposed § 1308.2(a)
would only remove the obligation to
have children’s toys and child care
articles tested by a third party
conformity assessment body. Regardless
of any third party testing relief that the
proposed rule would provide, the
manufacturer or importer must still
comply with the underlying phthalates
content prohibitions in section 108 of
the CPSIA.
E. Effective Date
The Administrative Procedure Act
(APA) generally requires that a
substantive rule must be published not
less than 30 days before its effective
date. 5 U.S.C. 553(d)(1). 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 NPR will
not have a significant 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.
Specifically, the IRFA must contain:
• A description of the reasons why
action by the agency is being
considered;
• a succinct statement of the
objectives of, and legal basis for, the
proposed rule;
• a description of, and where feasible,
an estimate of the number of small
entities to which the proposed rule will
apply;
• a description of the projected
reporting, recordkeeping, and other
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compliance requirements of the
proposed rule, including an estimate of
the classes of small entities subject to
the requirements and the types of
professional skills necessary for the
preparation of reports or records; and
• an identification, to the extent
possible, of all relevant federal rules
which may duplicate, overlap, or
conflict with the proposed rule.
2. Reason for Agency Action and Legal
Basis for the Proposed Rule
The Commission is proposing this
NPR to reduce the burden of third party
testing on toy and child care article
manufacturers, especially the burden on
those that are small entities. Based on
an extensive literature review seeking
information on the raw materials used
in the manufacture of the specified
plastics, the worldwide manufacturing
practices of the plastics, the typical
applications, and the potential for
exposure to the specified phthalates
through the use of recycled materials or
due to contamination, the Commission
concludes that there is a high degree of
assurance that polypropylene,
polyethylene, high impact polystyrene,
and acrylonitrile butadiene styrene with
the accompanying additives in the
proposed rule will not contain any of
the prohibited phthalates in
concentrations above 0.1 percent when
used in children’s toys and child care
articles. Therefore, third party testing is
not necessary to assure that children’s
toys and child care articles with
accessible component parts made from
these plastics and accompanying
additives do not contain the prohibited
phthalates.
3. Small Entities To Which the Proposed
Rule Would Apply
The proposed rule would apply to
small entities that manufacture or
import children’s toys or child care
articles that contain accessible
polyethylene, polypropylene, high
impact polystyrene, or acrylonitrile
butadiene styrene and any
accompanying additives in component
parts. Toy manufacturers are classified
in North American Industry
Classification System (NAICS) category
33993 (‘‘Doll, Toy, and Game
Manufacturing’’). According to the U.S.
Bureau of the Census, in 2012 there
were 559 toy manufacturers in the
United States, of which 552 had fewer
than 500 employees and would be
considered small entities according to
the Small Business Administration
(SBA) criteria.14 Of the small
14 2012
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manufacturers, 326 had fewer than five
employees.
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. Toy
wholesalers are classified in NAICS
category 42392 (‘‘Toy and Hobby Goods
and Supplies Merchant Wholesalers’’).
According to the U.S. Bureau of the
Census, there were 2,096 firms in this
category.15 Of these, 2,021 had fewer
than 100 employees and would be
considered small businesses according
to SBA criteria. Toy retailers are
classified in NAICS category 45112
(‘‘Hobby, Toy, and Game Stores’’). There
could be about 5,800 toy retailers that
would meet the SBA criteria to be
considered a small entity.16 The number
of these small toy retailers that import
toys, as opposed to obtaining their
product from domestic sources is not
known.
The phthalate regulations also apply
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. These include toddler
beds, full size and non-full size cribs,
bassinets and cradles, bedside sleepers,
high chairs, hook-on-chairs, and booster
seats. Other child care articles include
sleepwear, and crib or cradle bumpers.
In its ongoing market research, CPSC
staff has identified 364 suppliers of
these products that would be considered
small according to criteria established
by the SBA. 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.
Child care articles would also include
products such as teethers (if they are not
medical devices), pacifiers, and bottle
nipples. Manufacturers of these
products are classified in NAICS
category 326299 (‘‘All other rubber
product manufacturing’’). There are 617
15 2012
County Business Patterns.
SBA considers a toy retailer (NAICS 45112)
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 2007, the average receipts for toy
manufacturers with more than 500 employees was
almost $500 million. The average receipts for the
next largest category for which summary data was
published, toy retailers with at least 100 but fewer
than 500 employees were about $12 million. There
were 5,864 firms in this NAICS category, of which
5,839 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: 2007.)
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firms classified in this NAICS code of
which 573 are considered to be small.17
However, this NAICS category includes
many other products and most of these
firms probably do not manufacture child
care articles.
Although, as discussed above, the
number of small companies that supply
children’s toys or child care articles to
the U.S. market might be close to
10,000, the number that actually supply
products with accessible polyethylene,
polypropylene, high impact
polystyrene, or acrylonitrile, butadiene
styrene component parts is not known.
Also not known is the number of
children’s toys and child care articles
that contain these plastics. To develop
comprehensive estimates of the number
of products that contain these plastics
and the number of firms that supply the
products it would probably be necessary
to survey a representative sample of toy
and child care article suppliers to solicit
information on their use of the four
plastics or to collect a representative
sample of children’s toys and child care
articles and analyze the accessible
components to determine which ones
contained one or more of the four
plastics.
Although comprehensive estimates of
the number of children’s toys and child
care articles that contain components
made from the four plastics are not
available, there is some evidence that
these plastics are extensively used in
children’s toys. One source stated that
polypropylene and high density
polyethylene are used in 38 and 25
percent, respectively, of injection
molded toys. Low density polyethylene
and acrylonitrile butadiene styrene, are
each used in less than 10 percent of the
injection molded toys. Polystyrene may
also be used in injection molded toys,
but the source does not specify the
proportion that is high impact
polystyrene.18 The Commission requests
comments to better determine the
impact the proposed determinations
would have on small entities.
4. Reporting, Recordkeeping, and Other
Compliance Requirements and Impact
on Small Businesses
The proposed rule would determine
that there is a high degree of assurance
that four specific plastics with any of
the accompanying additives will not
contain any prohibited phthalates at
concentrations above 0.1 percent
17 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: 2011,’’ 2011
County Business Patterns.
18 Donald V. Rosato, Plastics End Use
Applications, Springer, New York, (2011).
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prohibition level. As a result of the
proposed determinations,
manufacturers, importers, and private
labelers of children’s toys and child care
articles that have accessible components
that consist of these plastics and any
accompanying additives will not have to
obtain third party tests to certify that the
accessible components do not contain
the prohibited phthalates in
concentrations above 0.1 percent.
The proposed rule would not impose
any additional reporting, recordkeeping,
or other compliance requirements on
small entities. In fact, because the
proposed rule would eliminate a testing
requirement, there would be a small
reduction in some of the recordkeeping
burden under 16 CFR part 1107 and 16
CFR part 1109 because manufacturers
would no longer have to maintain
records of third party phthalate tests for
the component parts manufactured from
these four plastics.
A determination that specified
plastics with accompanying additives
used in children’s toys and child care
articles do not require third party testing
is expected to be entirely beneficial to
manufacturers and importers using
those plastics in accessible component
parts because manufacturers and
importers could forego testing they
otherwise would be required to conduct.
However, staff believes the magnitude of
that benefit is uncertain and could
depend on factors such as:
• The extent to which manufacturers
have already reduced their testing costs
by using component part testing (as
allowed in 16 CFR part 1109);
• the volume of children’s toys and
child care articles that contain PE, PP,
HIPS, or ABS;
• whether importers who certify
children’s products are unsure what
plastics are being used in the toys and
child care articles they import, so they
could not take advantage of the
determinations without additional
testing to assure that a component part
is composed of one of the four plastics.
The Commission welcomes comments
on the potential impact of the proposed
rule on small entities. Comments are
especially welcome on the following
topics:
• The extent to which PP, PE, HIPS,
or ABS 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;
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54762
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Proposed Rules
• Any situations or conditions in the
proposed rule that would make it
difficult to make use of the
determinations to reduce third party
testing costs; and
• Although the Commission expects
that the impact of the proposed rule will
be entirely beneficial, any potential
negative impacts of the proposed rule.
5. Other Federal Rules
We have not identified any Federal
rules that duplicate or conflict with the
proposed rule.
6. 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.
mstockstill on DSK3G9T082PROD with PROPOSALS
List of Subjects in 16 CFR Part 1308
Business and industry, Consumer
protection, Imports, Infants and
children, Product testing and
certification, Toys.
■ Accordingly, the Commission
proposes to amend Title 16 of the Code
of Federal Regulations by adding part
1308 to read as follows:
PART 1308—PROHIBITION OF
CHILDREN’S TOYS AND CHILD CARE
ARTICLES CONTAINING SPECIFIED
PHTHALATES: DETERMINATIONS
REGARDING CERTAIN PLASTICS
Sec.
VerDate Sep<11>2014
16:15 Aug 16, 2016
Jkt 238001
1308.1 Prohibited children’s toys and child
care articles containing specified
phthalates and testing requirements.
1308.2 Determinations for specified
plastics.
Authority: Sec. 3, Pub. L. 110–314, 122
Stat. 3016; 15 U.S.C. 2063(d)(3)(B).
§ 1308.1 Prohibited children’s toys and
child care articles containing specified
phthalates and testing requirements.
Section 108(a) of the Consumer
Product Safety Improvement Act of
2008 (CPSIA) permanently prohibits any
children’s toy or child care article that
contains concentrations of more than
0.1 percent of di-(2-ethylhexl) phthalate
(DEHP), dibutyl phthalate (DBP), or
benzyl butyl phthalate (BBP). Section
108(b)(1) of the CPSIA prohibits on an
interim basis any children’s toy that can
be placed in a child’s mouth or child
care article that contains concentrations
of more than 0.1 percent of diisononyl
phthalate (DINP), diisodecyl phthalate
(DIDP), or di-n-octyl phthalate (DnOP).
Materials used in children’s toys and
child care articles subject to section
108(a) and (b)(1) of the CPSIA must
comply with the third party testing
requirements of section 14(a)(2) of the
Consumer Product Safety Act (CPSA),
unless listed in § 1308.2.
§ 1308.2 Determinations for specified
plastics.
(a) The following plastics do not
exceed the phthalates content limits
with a high degree of assurance as that
term is defined in 16 CFR part 1107:
(1) Polypropylene (PP), with any of
the following additives:
(i) The plasticizers polybutenes,
dioctyl sebacate, paraffinic oil, isooctyl
tallate, mineral plasticizing oils, and
polyol;
(ii) Hydrocarbon solvents;
(iii) Catalysts;
(iv) Fillers;
(v) Primary and secondary
antioxidants;
(vi) Neutralizing agents;
(vii) Antistatic agents;
(viii) Slip agents;
(ix) Metal deactivators;
(x) Quenchers;
(xi) UV stabilizers;
(xii) Nucleating agents;
(xiii) Flame retardants;
(xiv) Blowing or foaming agents;
(xv) Antiblocking agents;
(xvi) Lubricants; or
(xvii) Colorants.
(2) Polyethylene (PE), with any of the
following additives:
(i) The plasticizers glyceryl
tribenzoate, polyethylene glycol,
sunflower oil, paraffin wax, paraffin oil,
mineral oil, glycerin, EPDM rubber, and
EVA polymer;
PO 00000
Frm 00015
Fmt 4702
Sfmt 9990
(ii) Initiators;
(iii) Promoters;
(iv) Catalysts;
(v) Fillers;
(vi) Antistatic agents;
(vii) Flame retardants;
(viii) Anti-blocking agents;
(ix) Slip agents;
(x) Blowing agents;
(xi) Ccross-linking agents;
(xii) Antioxidants;
(xiii) Carbon black; or
(xiv) Colorants.
(3) High-impact polystyrene (HIPS),
with any of the following additives:
(i) Catalysts;
(ii) Internal lubricants;
(iii) Chain transfer/transition agents;
(iv) Stabilizers;
(v) Diluents;
(vi) Colorants;
(vii) Aluminum chloride, ethyl
chloride, hydrochloric acid;
(viii) Iron oxide, potassium oxide,
chromium oxide; or
(ix) Bifunctional peroxides.
(4) Acrylonitrile butadiene styrene
(ABS), with any of the following
additives:
(i) The plasticizers phosphate esters,
long chain fatty acid esters and aromatic
sulfonamide;
(ii) Hydrocarbon solvents
(iii) Stabilizers;
(iv) Lubricants;
(v) Antioxidants;
(vi) Molecular weight regulators;
(vii) Initiators/catalysts,
(viii) Activators;
(ix) Emulsifiers; or
(x) Colorants.
(b) Accessible component parts of
children’s toys and child care articles
made with the specified plastics, and
specified additives, listed in paragraph
(a) of this section are not required to be
third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part
1107.
(c) Accessible component parts of
children’s toys and child care articles
made with a plastic or additives not
listed in paragraph (a) of this section are
required to be third party tested
pursuant to section 14(a)(2) of the CPSA
and 16 CFR part 1107.
Dated: August 11, 2016.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2016–19464 Filed 8–16–16; 8:45 am]
BILLING CODE 6355–01–P
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Agencies
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Proposed Rules]
[Pages 54754-54762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19464]
=======================================================================
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1308
[Docket No. CPSC-2016-0017]
Prohibition of Children's Toys and Child Care Articles Containing
Specified Phthalates: Determinations Regarding Certain Plastics
AGENCY: U.S. Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Consumer Product Safety Commission (Commission, or CPSC)
is proposing a rule to determine that certain plastics with specified
additives would not contain the specified phthalates prohibited in
children's toys and child care articles. Based on these determinations,
the specified plastics with specified additives would not require third
party testing for compliance with the mandatory phthalates prohibitions
on children's toys and child care articles.
DATES: Submit comments by October 31, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2016-
0017, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. The Commission does not accept
comments submitted by electronic mail (email), except through
regulations.gov. The Commission encourages you to submit electronic
comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written comments by mail/hand delivery/
courier to: Office of the Secretary, 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. All comments received may be posted without change,
including any personal identifiers, contact information, or other
personal information provided, to: https://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 by mail/hand delivery/courier.
FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager,
Office of Hazard Identification and Reduction U.S. Consumer Product
Safety Commission, 4330 East West Hwy., Room 814, Bethesda, MD 20814;
301-504-7562: email; rbutturini@cpsc.gov.
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
[[Page 54755]]
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).
2. Prohibitions in Section 108 of the CPSIA
Section 108 of the CPSIA prohibits children's toys and child care
articles that contain six specified phthalates in concentrations above
0.1 percent in ``accessible plasticized component parts and other
component parts made of materials that may contain phthalates.'' The
prohibited phthalates in section 108 of the CPSIA are listed in Table
1. Children's toys and child care articles subject to the content
limits in section 108 of the CPSIA require third party testing for
compliance with the phthalate content limits before the manufacturer
can issue a Children's Product Certificate (CPC) and enter the
children's toys or child care articles into commerce.
Table 1--Statutorily Prohibited Phthalates
------------------------------------------------------------------------
-------------------------------------------------------------------------
Permanent prohibition on phthalates in children's toys and child care
articles
------------------------------------------------------------------------
DEHP: di-(2-ethylhexyl) phthalate
DBP: dibutyl phthalate
BBP: benzyl butyl phthalate
------------------------------------------------------------------------
Interim prohibition on phthalates in children's toys and child care
articles
------------------------------------------------------------------------
DINP: diisononyl phthalate
DIDP: diisodecyl phthalate
DnOP: di-n-octyl phthalate
------------------------------------------------------------------------
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.'' The CHAP issued its report in July 2014.\1\
Based on the CHAP report, the Commission published a notice of proposed
rulemaking (NPR) \2\ proposing to make the interim prohibition on DINP
in children's toys and child care articles permanent, and proposing to
lift the interim statutory prohibitions on DIDP and DnOP in children's
toys and child care articles. In addition, the NPR proposed adding four
new phthalates to the prohibited list of phthalates that cannot exceed
0.1 percent concentration in accessible component parts of children's'
toys and child care articles. Table 2 contains the list of phthalates
that the NPR proposed to prohibit in children's toys and child care
articles.
---------------------------------------------------------------------------
\1\ https://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf.
\2\ https://www.federalregister.gov/articles/2014/12/30/2014-29967/prohibition-of-childrens-toys-and-child-care-articles-containing-specified-phthalates.
Table 2--Proposed Prohibited Phthalates
------------------------------------------------------------------------
Phthalates
-------------------------------------------------------------------------
DEHP: di-(2-ethylhexyl) phthalate
DBP: dibutyl phthalate
BBP: benzyl butyl phthalate
DINP: diisononyl phthalate
DIBP: diisobutyl phthalate
DPENP: di-n-pentyl phthalate
DHEXP: di-n-hexyl phthalate
DCHP: dicyclohexyl phthalate
------------------------------------------------------------------------
B. Contractor's Research on Phthalates in Consumer Products
CPSC contracted with Toxicology Excellence for Risk Assessment
(TERA) to conduct research on phthalates and provide CPSC with two
research reports on phthalates relevant to this rulemaking. TERA
conducted a literature search on the production and use of 11 specified
phthalates in consumer products (Task 11 Report).\3\ The 11 phthalates
researched by TERA are based on the phthalates assessed by the CHAP and
the recommendations made in the CHAP report. Additionally, the CPSC
contracted with TERA to conduct a literature search on whether
specified plastics could be determined not to contain any of the 11
phthalates in concentrations above the CPSIA limit of 0.1 percent (Task
12 Report).\4\
---------------------------------------------------------------------------
\3\ https://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Other%20Technical%20Reports/TERAReportPhthalates.pdf. The work was conducted as a task order
(Task 11) under CPSC contract CPSC-D-12-0001.
\4\ https://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Other%20Technical%20Reports/ReportonPhthalatesinFourPlastics.pdf. The work was conducted as a
task order (Task 12) under CPSC contract CPSC-D-12-0001.
---------------------------------------------------------------------------
TERA used a tiered literature research approach to identify sources
for review from among the ``universe'' of available data. The tiers
were used to provide a structured search method to locate relevant
sources and eliminate unrelated material. TERA used books, factsheets,
journal articles, patents, and other sources as primary and secondary
literature sources. The use of this tiered approach resulted in a
comprehensive review of the available literature that is representative
of the information available on the potential for the presence of any
of the 11 phthalates in the 4 specified plastics.
TERA screened over 119,800 studies identified by the above
described tiered search method for relevance to the 11 phthalates and 4
plastics. CPSC staff reviewed the information provided in the
contractor report and formulated recommendations for Commission
consideration based on TERA's research.
The plastics researched by TERA were:
Polypropylene (PP);
Polyethylene (PE);
High-impact polystyrene (HIPS); and
Acrylonitrile butadiene styrene (ABS).
TERA's research included the following factors:
The raw materials used in the production of the specified
plastics;
The manufacturing processes used worldwide to produce the
plastics;
Typical applications for the specified plastics in
consumer products, especially toys and child care articles, focusing on
circumstances where the plastic could contain phthalates at
concentrations greater than 0.1 percent;
The potential use of recycled materials containing the
specified phthalates in the production of the plastics; and
The potential for phthalate contamination during
packaging, storage, use, or other factors.
C. CPSC Staff Analysis
1. Polypropylene (PP)
TERA's research indicated the production of PP plastic uses a PP
monomer, ethylene, and other monomers, a hydrocarbon solvent,
catalysts, nucleating agents or fillers, and a number of other
additives, depending on the type of PP and other manufacturing
considerations. Additives can be included in PP to achieve various
chemical and mechanical characteristics. PP can include the following
additives:
Hydrocarbon solvents: Examples of solvents used are hexane
and heptane;
[[Page 54756]]
Catalysts: \5\ Catalysts used in producing PP are the
Ziegler-Natta catalysts; \6\
---------------------------------------------------------------------------
\5\ The Merriam-Webster online dictionary defines a ``catalyst''
as ``a substance that causes or accelerates a chemical reaction
without itself being affected.'' A catalyst is not consumed,
altered, or incorporated into one of the reaction's products.
\6\ A Ziegler-Natta catalyst, named after Karl Ziegler and
Giulio Natta, is a class of catalyst used in the production of some
plastics.
---------------------------------------------------------------------------
Fillers: Fillers are added to plastics to enhance their
performance (e.g., impact resistance, shrink resistance), and reduce
manufacturing costs. Examples of fillers used in PP include talc,
calcium carbonate, and fiberglass;
Primary antioxidants: Antioxidants inhibit oxidative
deterioration of a material. Primary antioxidants donate hydrogen atoms
to prevent free radical creation. Examples of primary antioxidants
include hindered phenol, such as butylated hydroxytoluene, and hindered
amine light stabilizers;
Secondary antioxidants: Secondary antioxidants prevent
degradation by breaking down free radicals and hydroperoxides, and
synergize with the primary antioxidants. Examples of secondary
antioxidants include phosphites and thioesters;
Neutralizing agents: Neutralizing agents adjust the
acidity of the chemicals during production, and can include calcium and
zinc stearate, zeolites, calcium and zinc oxides, and metallic salts of
lactic or benzoic acid;
Antistatic agents: Antistatic agents reduce the buildup of
static electricity, and can include cationic compounds, anionic
compounds, and nonionic compounds;
Slip agents: Slip agents are added to reduce a plastic
surface's coefficient of friction. Examples of slip agents include
modified fatty acids or fatty amides;
Metal deactivators: Transition metals like copper and iron
can accelerate plastic degradation. Metal deactivators, such as N,N'-
dibenzaloxaldihydrazide, combine with the metal ions and prevent
catalytic degradation of the plastic;
Quenchers: Quenchers scavenge stray free radicals and
decompose unwanted peroxides. Examples of quenchers are organic nickel
complexes, nickel salts of thiocarbamate, and nickel complexes with
alkylated phenol phosphonates;
UV stabilizers: Ultraviolet (UV) stabilizers are added to
PP to protect the plastic from degradation in sunlight. Examples of UV
stabilizers are hindered amine light stabilizers, carbon black,
titanium dioxide, zinc oxide, derivatives of benzophenone,
benzotriazoles, phenyl, aryl, or acrylic esters, formamidines, and
oxanilides;
Nucleating agents: Nucleating agents are additives that
increase the crystallization of a plastic from a liquid solution.
Examples of nucleating agents for PP include carboxylic acids, benzyl
sorbitols, and salts of organic phosphates;
Flame retardants: Examples of flame retardants include
brominated flame retardants, cycloaliphatic chlorines; antimony
trioxide, ferric oxide, zinc oxide, zinc borate, barium metaborates;
phosphorus flame retardants, magnesium hydroxide, and aluminum
hydroxide;
Blowing or foaming agents: Blowing and foaming agents
create gas bubbles during molding, resulting in a foamed plastic.
Examples of blowing and foaming agents include sodium bicarbonate,
sodium borohydride, polycarbonic acid, citric acid,
4,4'oxybis(benzenesulfonyl hydrazide), azodicarbonamide, or para-
toluenesulfonyl semicarbazide;
Antiblocking agents: Antiblocking agents are used to
prevent plastic films from sticking together through cold flow or
static electricity. Examples of antiblocking agents include natural and
manufactured waxes, metallic salts of fatty acids, silica compounds,
and some polymers (e.g., polyvinyl alcohol, polyamides, polyethylene,
polysiloxanes, and fluoroplastics);
Lubricants: Lubricants are used in PP (and other plastics)
to lower the molten material's coefficient of viscosity and prevent the
plastic from sticking to metal surfaces. The lubricants allow the
plastic's hydrocarbon chains to slip past each other in the melt.
Examples of lubricants include metal soaps, hydrocarbon waxes,
polyethenes, amide waxes, fatty acids, and fatty alcohols, (e.g.,
calcium or zinc stearates); or
Colorants: Colorants for plastics typically consist of
dyes, in which the color-producing material is dissolved in a carrier
medium, and pigments, in which very small particles of the color-
producing material are suspended in the carrier medium. Examples of
colorants used in PP include heavy metal-based oxides, sulfides,
chromates, and other complexes, including cadmium, zinc, titanium,
lead, molybdenum; and ultramines (sulfide-silicate complexes containing
sodium and aluminum; azo pigments).
The research showed that among all of these raw materials and
additives, only Ziegler-Natta catalysts may contain one or more of the
prohibited phthalates. Ziegler-Natta catalysts are generally titanium-
based catalyst systems in combination with an organoaluminum co-
catalyst, and an internal donor (a molecule that contributes an
electron to the chemical reaction), such as DBP, DIBP or DEHP. As
described in the Task 12 Report, these catalysts may survive the
plastic's polymerization process, and the phthalates may be present in
the final plastic pellets, theoretically at concentrations of about 1
mg/kg (1 part per million, ``ppm''). The Task 12 Report references an
industry analysis in the context of European regulations that indicates
that phthalate concentrations in PP do not exceed 0.15 mg/kg (0.15 ppm)
and are often below the measurement threshold of the analytical method
of 0.01 mg/kg (0.01 ppm).
2. Polyethylene (PE)
TERA's research indicated that PE is manufactured using PE monomers
or certain copolymers or other monomers, and a number of additives.
Additives can be included in PE to achieve various chemical and
mechanical characteristics. PE can include the following additives:
Plasticizers: \7\ Examples of plasticizers for PE include
glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax,
paraffin oil, mineral oil, glycerin, EPDM rubber, EVA polymer, DOP; \8\
---------------------------------------------------------------------------
\7\ The Task 12 Report indicated that several prohibited
phthalates are used as plasticizers in PE. CPSC staff reviewed the
report's references for this information. As cited in the Task 12
Report, Bhunia et al. (2013) reported several phthalates used in
food packaging plastic films, including PE, referencing Sablani and
Rahman (2007). In the latter reference, staff did not find any
support for the claimed uses of phthalates. In fact, in the section
on plasticizers, Sablani and Rahman (2007) stated that most
plasticizers are used in PVC and that as a result of studies on
migration of plasticizers from food packaging, ``. . . industry has
replaced PVC with other polymers, such as PE or regenerated
cellulose not associated with plasticizers.'' (emphasis added)
\8\ The isomer of DOP was not specified. DOP can include DEHP.
---------------------------------------------------------------------------
Initiators: Initiators help form the plastic
macromolecules from the solution. Examples of PE initiators are benzoyl
peroxide, azodi-isobutyronitrile, and oxygen;
Promoters: Promoters in PE improve paint adhesion and
resistance to some solvents. PE promoters include sodium and calcium
(in metal or hydride form);
Catalysts: Catalysts for PE include the Ziegler-Natta
catalysts, and metallocene catalysts (e.g., zirconium, titanium);
Fillers: silane and titanate coupling agents are used as
fillers in PE;
Antistatic agents: PE antistatic agents include
polyethylene glycol alkyl esters;
[[Page 54757]]
Flame retardants: PE flame retardants include antimony
trioxide, and halogenated substances;
Anti-blocking agents: Fine silicas are an example of a PE
antiblocking agent;
Slip agents: PE slip agents include fatty acid amides such
as oleamide and erucamide;
Blowing agents: PE blowing agents include 4,4'-
oxybisbenzenesulfono- hydrazine and azocarbonamide;
Cross-linking agents: Cross-linking agents set up chemical
bonds between the plastic macromolecules and assists in ``curing'' the
plastic. Examples of cross-linking agents include dicumyl peroxide, and
vinyl silanes;
Antioxidants: PE antioxidants include 4-methyl-2,6-t-butyl
phenol, 1,1,3-tris-(4-hydroxy-2-methyl-5-butylphenyl)butane, bis-[2-
hydroxy-5-methyl-3-(1-methylcyclohexyl)phenyl]- methane, and dilauryl-
[beta],[beta]'-thiodipropionate;
Carbon black; or
Colorants: PE colorants are often based on cobalt,
cadmium, and manganese.
As with PP, PE catalysts include an internal donor, such as DBP,
DIBP, or DEHP, although the phthalate concentration in the final
plastic is generally well below 0.15 mg/kg (0.15 ppm).
One reference in the Task 12 report indicated that DOP can be used
as a plasticizer in PE. Staff reviewed the cited references, as well as
citations within the references, and found that uses of DOP in PE are
mentioned in patents for specialized materials with no known current
consumer product application, or may be used in materials, such as
pavement marking, which are not children's products. One cited patent
described use of phthalates in a PE microporous film used as an
internal separator for lithium ion batteries.
The Task 12 Report cited a patent for a material made with PE
plastic and DBP for use as a surface for outdoor athletic track,
basketball, volleyball, and playgrounds. CPSC staff found no
information indicating that such a product has been manufactured and
marketed for consumer use. Furthermore, the applications for the
material do not include children's toys or child care articles that are
subject to the phthalate content restrictions.
3. High-Impact Polystyrene (HIPS)
TERA's research indicated that HIPS is a plastic blend generally
produced from styrene, polybutadiene rubber, benzene, and a number of
other substances. Additives can be included in HIPS to achieve various
chemical and mechanical characteristics. HIPS can include the following
additives:
Catalysts: The Ziegler-Natta catalysts;
Internal lubricant: Zinc stearate is a lubricant for HIPS;
Chain transfer/transition agent: Chain transfer/transition
agents regulate the length of the HIPS macromolecules. HIPS chain
transfer/transition agents include tertdocecylmercaptan and liquid
paraffin;
Stabilizer: Tert-butylcatechol is a stabilizer for HIPS;
Diluents: Diluents are used to reduce the concentration of
a plastic as a means to reduce the plastic's viscosity and to modify
its processing conditions. Examples of HIPS diluents include
ethylbenzene, and toluene; or
Colorants: HIPS colorants include azo dyes, anthraquinone
dyes, perinone dyes, or xanthene dyes.
Other additives: Additional materials used in the
manufacture of HIPS include:
[cir] Aluminum chloride, ethyl chloride, hydrochloric acid;
[cir] Iron oxide, potassium oxide, chromium oxide; and
[cir] Bifunctional peroxides.
As with PP and PE, the polybutadiene used in HIPS production is
made with the use of catalysts that include an internal donor, such as
DBP, DIBP, or DEHP. Although no testing for phthalate content was
located, because the use of phthalate in HIPS is as a catalyst, the
concentration in the final product is expected to be well below 0.1
percent.
4. Acrylonitrile Butadiene Styrene (ABS)
TERA's research indicated that ABS plastic is manufactured with
specific monomers, such as acrylonitrile, butadiene, and styrene,
trans-1,4-butadiene, cis-1,4-butadiene, and 1,2-butadiene. Additives
are included in ABS to achieve various chemical and mechanical
characteristics. ABS can include the following additives:
Plasticizers: ABS plasticizers include hydrocarbon
processing oil, triphenyl phosphate, resorcinol bis(diphenyl
phosphate), oligomeric phosphate, long chain fatty acid esters, and
aromatic sulfonamide;
Hydrocarbon solvents: hexane, heptane, and ethyl benzene;
Stabilizers against heat or light degradation: Stabilizer
examples include phenolic antioxidants, thiol-containing antioxidants,
phosphites, thioesters, substituted benzophenones and benzotriazoles,
and hindered amines;
Lubricants: ABS lubricants include metallic stearates,
montan waxes or amide waxes; \9\
---------------------------------------------------------------------------
\9\ The TERA Task 12 Report did not specify ABS lubricants. CPSC
staff supplemented the Task 12 Report with additional research.
---------------------------------------------------------------------------
Antioxidants: Phenolic-based or phosphate-based
antioxidants are used in the manufacture of ABS;
Molecular weight regulator: An example of an ABS
molecular-weight regulator is tert-dodecyl mercaptan;
Initiators/catalysts: ABS initiators and catalysts include
potassium persulfate, sodium persulfate, oil-soluble initiators in a
redox system (cumene hydroperoxide, sodium pyrophosphate, dextrose, and
iron (II) sulfate);
Activators: Activators prepare the ABS surface for
electroplating. The activators in ABS are often palladium and tin salts
in an acid solution; \10\
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\10\ The TERA Task 12 Report did not specify ABS activators.
CPSC staff supplemented the Task 12 Report with additional research.
---------------------------------------------------------------------------
Emulsifiers: Emulsifiers are chemicals that promote the
mixing of hydrophilic and hydrophobic materials. ABS emulsifiers
include salts of rosin, fatty sodium lauryl sulfate, and oleate;
Colorants: ABS colorants include phthalocyanines,
perylenes, cromophtals, titanium dioxide, carbon black, black iron
oxide, ultramarine blue, red iron oxide, and aluminum flake.\11\
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\11\ The TERA Task 12 Report did not specify ABS colorants. CPSC
staff supplemented the Task 12 Report with additional research.
---------------------------------------------------------------------------
5. Additional CPSC Staff Research
TERA's research did not include an examination of the colorants in
polyethylene, high-impact polystyrene, or acrylonitrile butadiene
styrene. TERA's research also did not include an examination of the
lubricants, activators, and antioxidants that could be used in the
production of ABS. CPSC staff conducted additional research into these
component parts of the plastics.
6. Potential Phthalate Use in the Four Plastics
The Task 11 Report indicates that phthalates are used generally as
plasticizers or softeners of certain plastics, primarily polyvinyl
chloride (PVC), as solvents, and as components of inks, paints,
adhesives, and sealants. Except for the general category of inks and
colorants, the Task 11 Report did not indicate uses of the prohibited
phthalates in any of the four plastics, in the raw materials, or in the
types of additives that might be used in the four plastics.
The four plastics may also be used as ingredients in a variety of
materials. For
[[Page 54758]]
example, PP may be used in formulations for concrete, paints, and
lubricating grease. These materials would not be considered to be PP
plastic. PE, HIPS, ABS also may be used as additives in materials that
would not be considered plastics.
The TERA Task 11 and Task 12 Reports indicate that the phthalates
researched are not associated with the chemistry and applications of
the plastics PP, PE, HIPS, or ABS. When these plastics are plasticized,
materials other than the phthalates are used as plasticizers (e.g.,
hydrocarbon processing oil, phosphate esters, long chain fatty acid
esters, and aromatic sulfonamide for ABS). TERA found one reference in
which DnOP (also referred to as DOP) was used as a plasticizer for PE.
However, the only application cited was a patent for a microporous
plastic film used in the production of lithium-ion batteries. TERA's
research included references prior to and after the enactment of the
CPSIA, none of which indicated any phthalate use in the four plastics.
7. Studies Where Phthalates Were Detected
TERA's investigation of the uses of the four plastics shows that
all four are used to make plastic consumer products and component
parts. None of these applications specifically includes phthalates,
although a few studies of the phthalate content of products were
located.
Several studies evaluated food, beverage, and cosmetics packaging
made with PP, PE, and polystyrene (PS). These studies generally
measured migration of specified chemicals, including phthalates, from
products purchased in retail stores. The references provided few or no
details about all the materials used in the products, including whether
other plastics were present, whether other component parts were present
such as coatings, finishes, inks, or adhesives, or whether residues of
the contained products were present.
The Task 12 Report also cited a Korean study of various products
that reported low levels of phthalates in a toy car made with ABS. The
study provided no details about other materials used in the product,
including whether other plastics were present, or whether other
component parts were present such as coatings, finishes, inks, or
adhesives.
The Task 12 Report's detailed description of the raw materials and
manufacturing processes for PP, PE, HIPS, and ABS plastics showed that
phthalates are not present after these plastics are produced. However,
the Task 11 Report describes uses of phthalates in materials on these
plastics, such as coatings, inks, and adhesives. Because consumer
products purchased in stores likely consist of a number of different
component parts, some of which may have contained phthalates, the
studies described above should not be considered to be evidence that
phthalates were used in the manufacture of the PP, PE, HIPS, or ABS
plastic component parts of consumer products subject to the phthalate
content restrictions.
8. Phthalates in Recycled Materials
All four plastics may be recycled and reprocessed into new
products. However, degradation of the original plastics during the
recycling process and mixing with other plastics or materials in the
recycling steam can reduce the quality of the recovered plastic and
limit further commercial uses. In some cases, recovered plastics are
mixed with virgin plastics to improve the products' quality and
utility. The Task 12 Report indicated that few studies were located for
analysis of phthalates in recycled plastics. One study found no
phthalates in recycled PP carpet. Two studies analyzed solid waste
consisting of PP or PE. One study reported detection of phthalates in
recovered waste PP and PE material, but not in samples of virgin PP or
PE plastic. The other study reported phthalates in recovered PE. The
authors of the latter study suggested that the source of phthalates
could have been the products that had been in contact with the plastic.
HIPS and ABS are generally used as rigid materials; available
information does not indicate use of phthalates in such materials or
associated with recycled HIPS or ABS.
Some studies indicated the potential for low, but detectable,
levels of phthalates in plastics, such as PP or PE packaging that
contained or had been in contact with a phthalate-containing product.
Products made with such materials could contain residual phthalates,
although at levels well below the maximum allowed concentration in
children's products.\12\
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\12\ The highest level recorded by Huber and Franz was 200 ppm
for one sample of DBP. The other samples' concentrations ranged from
3.1 to 96.3 ppm.
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9. Staff Conclusions Based on TERA Research
With the exception of the catalysts for polymerization, and
certain, specific uses of phthalates in products without consumer
product applications, neither of the TERA task reports, nor research by
CPSC staff found that phthalates are used as a component part of the
four plastics. In the case of the phthalate catalysts used in plastics
manufacturing, the phthalate concentration in finished plastics is
significantly below the maximum allowable concentration.
The two TERA task reports and CPSC staff research show that very
little information exists that indicates that manufactured PP, PE,
HIPS, and ABS plastics could contain the researched phthalates. The
research located references, including patents, for uncommon and
specialized products, and products that generally do not have
applications to children's toys and child care articles.
Staff found no evidence that phthalates are present at
concentrations above 0.1 percent in any of the four plastics (either
virgin or using recycled material) for consumer products, especially
children's products.
D. Determinations for Specified Plastics
1. Legal Requirements for a Determination
As noted above, section 14(a)(2) of the CPSA requires third party
testing for children's products that are subject to a children's
product safety rule. 15 U.S.C. 2063(a)(2). Children's toys and child
care articles must comply with the phthalates prohibitions in section
108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction,
the Commission has investigated approaches that would reduce the burden
of third party testing while also assuring compliance with CPSC
requirements. As part of that endeavor, the Commission has considered
whether certain materials used in children's toys and child care
articles would not require third party testing.
To issue a determination that a plastic (including specified
additives) does not require third party testing, the Commission must
have sufficient evidence to conclude that the plastic and specified
additives would consistently comply with the CPSC requirement to which
the plastic (and specified additives) is subject so that third party
testing is unnecessary to provide a high degree of assurance of
compliance. Under 16 CFR 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 a material determination, a high degree of assurance of
compliance means that the material will comply
[[Page 54759]]
with the specified chemical limits due to the nature of the material or
due to a processing technique that reduces the chemical concentration
below its limit. For materials determined to comply with a chemical
limit, the material must continue to comply with that limit if it is
used in a children's product subject to that requirement. A material on
which a determination has been made cannot be altered or adulterated to
render it noncompliant and then used in a children's product.
Phthalates are not naturally occurring materials, but are
intentionally created and used in specific applications (e.g.,
plastics, surface coatings, solvents, inks, adhesives, and some
rubberized materials). One application of phthalates in children's toys
and child care articles is as a plasticizer, or softener for plastic
component parts.\13\ The addition of a plasticizer converts an
otherwise rigid plastic into a more flexible form, such as in a child's
rubber duck or a soft plastic doll. Because plastics can contain the
prohibited phthalates, third party testing is required before a CPC can
be issued for children's toys and child care articles with accessible
plastic component parts. However, some specific plastics with certain
additives might not use any of the prohibited phthalates as a
plasticizer, or for any other purpose. For these specific plastics and
accompanying additives, compliance with the requirements of section 108
of the CPSIA can be assured without requiring third party testing. As a
means to reduce the third party testing burden on children's product
certifiers while continuing to ensure compliance, the CPSC is proposing
to make determinations that specified plastics with certain additives
comply with the phthalate content requirements of section 108 of the
CPSIA based on evidence indicating that such materials will not contain
the prohibited phthalates.
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\13\ The Merriam-Webster online dictionary defines a plasticizer
as ``a chemical added especially to rubbers and resins to impart
flexibility, workability, or stretchability.''
---------------------------------------------------------------------------
Based on the discussion in section C of this preamble, the
Commission proposes to determine that the specified four plastics and
accompanying additives would comply with the phthalates prohibitions
with a high degree of assurance. These determinations mean that third
party testing for compliance with the phthalates prohibitions is not
required for certification purposes for the specified four plastics.
The Commission 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. As noted previously, section
14 of the CPSA, which was amended by the CPSIA, requires third party
testing for children's products subject to a children's product safety
rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended
by Public Law 112-28, gives the Commission the authority to ``prescribe
new or revised third party testing regulations if it determines that
such regulations will reduce third party testing costs consistent with
assuring compliance with the applicable consumer product safety rules,
bans, standards, and regulations.'' Id. 2063(d)(3)(B). These statutory
provisions authorize the Commission to issue a rule determining that
specified plastics and additives will not exceed the phthalates
prohibitions of section 108 of the CPSIA, and therefore, specified
plastics do not require third party conformity assessment body testing
to assure compliance with the phthalates limits in section 108 of the
CPSIA.
The proposed determinations would relieve the four specified
plastics and accompanying additives from the third party testing
requirement of section 14 of the CPSA for purposes of supporting the
required certification. However, the proposed determinations would not
be applicable to any other plastic or additives beyond those listed in
the proposed rule.
The proposed determinations would only relieve the manufacturers'
obligation to have the specified plastics and accompanying additives
tested by a CPSC accepted third party conformity assessment body.
Children's toys and child care articles must still comply with the
substantive phthalates content limits in section 108 of the CPSIA
regardless of any relief on third party testing requirements.
3. Description of the Proposed Rule
This proposed rule would create a new Part 1308 for ``Prohibition
of Children's Toys and Child Care Articles Containing Specified
Phthalates: Determinations Regarding Certain Plastics.'' The proposed
rule would determine that the specified four plastics and accompanying
additives do not contain the statutorily prohibited phthalates (DEHP,
DBP, BBP, DINP, DIDP, DnOP) in concentrations above 0.1 percent, and
thus, are not required to be third party tested to assure compliance
with section 108 of the CPSIA. As discussed in section A.2 of the
preamble, the agency is currently involved in rulemaking to determine
whether to continue the interim prohibitions in section 108 and whether
to prohibit any other children's products containing any other
phthalates. TERA's examination covered all phthalates that are subject
to the current permanent and interim prohibitions, as well as the
additional phthalates the Commission proposed restricting in the
phthalates proposed rule. If the Commission issues a final rule in the
phthalates rulemaking before finalizing this determinations rulemaking,
the Commission would modify the determinations proposed rule so that
the determinations rule covers the same phthalates restricted by the
final phthalates rule.
Section 1308.1 of the proposed rule explains the statutorily-
created requirements for children's toys and child care articles under
section 108 of the CPSIA and the third party testing requirements for
children's products.
Section 1308.2(a) of the proposed rule would establish the
Commission's determinations that the following plastics do not exceed
the phthalates content limits with a high degree of assurance as that
term is defined in 16 CFR part 1107:
Polypropylene, with any of the following additives:
[cir] the plasticizers polybutenes, dioctyl sebacate, paraffinic
oil, isooctyl tallate, mineral plasticizing oils, and polyol;
[cir] hydrocarbon solvents;
[cir] catalysts;
[cir] fillers;
[cir] nucleating agents;
[cir] primary and secondary antioxidants;
[cir] neutralizing agents;
[cir] antistatic agents;
[cir] slip agents;
[cir] metal deactivators;
[cir] quenchers;
[cir] UV stabilizers;
[cir] flame retardants;
[cir] blowing or foaming agents;
[cir] antiblocking agents;
[cir] lubricants; or
[cir] colorants.
Polyethylene, with any of the following additives:
[cir] the plasticizers glyceryl tribenzoate, polyethylene glycol,
sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM
rubber, and EVA polymer;
[cir] catalysts;
[[Page 54760]]
[cir] initiators;
[cir] promoters;
[cir] antistatic agents;
[cir] fillers;
[cir] flame retardants;
[cir] anti-blocking agents;
[cir] slip agents;
[cir] blowing agents;
[cir] cross-linking agents;
[cir] antioxidants;
[cir] carbon black; or
[cir] colorants.
High-impact polystyrene, with any of the following
additives:
[cir] catalysts;
[cir] internal lubricants;
[cir] chain transfer/transition agents;
[cir] stabilizers;
[cir] diluents;
[cir] colorants;
[cir] aluminum chloride, ethyl chloride, hydrochloric acid;
[cir] iron oxide, potassium oxide, chromium oxide; or
[cir] bifunctional peroxides.
Acrylonitrile butadiene styrene, with any of the following
additives:
[cir] the plasticizers phosphate esters, long chain fatty acid
esters and aromatic sulfonamide;
[cir] hydrocarbon solvents;
[cir] stabilizers;
[cir] lubricants;
[cir] antioxidants;
[cir] molecular weight regulators;
[cir] initiators/catalysts,
[cir] activators;
[cir] emulsifiers; or
[cir] colorants.
Section C.2 of the preamble provides a more detailed discussion of
the additives for each of the four plastics with the specified
additives including definitions of the additives and various examples
of the types of additives.
Section 1308.2(b) of the proposed rule states that accessible
component parts of children's toys and child care articles made with
the specified plastics, and specified additives listed in paragraph (a)
of that section, are not required to be third party tested pursuant to
section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed Sec.
1308.2(b) is included in the rule to make clear that when the listed
plastics and accompanying additives are used in children's toys and
child care articles, manufacturers and importers are not required to
conduct the third party testing required in section 14(a)(2) of the
CPSA and 16 CFR part 1107. Section 1308.2(c) of the proposed rule
states that accessible component parts of children's toys and child
care articles made with a plastic or additives not listed in paragraph
(a) of this section are required to be third party tested pursuant to
section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed Sec.
1308.2(c) is intended to make clear that if a manufacturer or importer
uses any other plastic or additive in a children's toy or child care
article not listed in proposed Sec. 1308.1(a), that children's toy or
child care article must be third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part 1107. Finally, the determinations
in proposed Sec. 1308.2(a) would only remove the obligation to have
children's toys and child care articles tested by a third party
conformity assessment body. Regardless of any third party testing
relief that the proposed rule would provide, the manufacturer or
importer must still comply with the underlying phthalates content
prohibitions in section 108 of the CPSIA.
E. Effective Date
The Administrative Procedure Act (APA) generally requires that a
substantive rule must be published not less than 30 days before its
effective date. 5 U.S.C. 553(d)(1). 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 NPR will not have a
significant 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. Specifically, the IRFA must contain:
A description of the reasons why action by the agency is
being considered;
a succinct statement of the objectives of, and legal basis
for, the proposed rule;
a description of, and where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
a description of the projected reporting, recordkeeping,
and other compliance requirements of the proposed rule, including an
estimate of the classes of small entities subject to the requirements
and the types of professional skills necessary for the preparation of
reports or records; and
an identification, to the extent possible, of all relevant
federal rules which may duplicate, overlap, or conflict with the
proposed rule.
2. Reason for Agency Action and Legal Basis for the Proposed Rule
The Commission is proposing this NPR to reduce the burden of third
party testing on toy and child care article manufacturers, especially
the burden on those that are small entities. Based on an extensive
literature review seeking information on the raw materials used in the
manufacture of the specified plastics, the worldwide manufacturing
practices of the plastics, the typical applications, and the potential
for exposure to the specified phthalates through the use of recycled
materials or due to contamination, the Commission concludes that there
is a high degree of assurance that polypropylene, polyethylene, high
impact polystyrene, and acrylonitrile butadiene styrene with the
accompanying additives in the proposed rule will not contain any of the
prohibited phthalates in concentrations above 0.1 percent when used in
children's toys and child care articles. Therefore, third party testing
is not necessary to assure that children's toys and child care articles
with accessible component parts made from these plastics and
accompanying additives do not contain the prohibited phthalates.
3. Small Entities To Which the Proposed Rule Would Apply
The proposed rule would apply to small entities that manufacture or
import children's toys or child care articles that contain accessible
polyethylene, polypropylene, high impact polystyrene, or acrylonitrile
butadiene styrene and any accompanying additives in component parts.
Toy manufacturers are classified in North American Industry
Classification System (NAICS) category 33993 (``Doll, Toy, and Game
Manufacturing''). According to the U.S. Bureau of the Census, in 2012
there were 559 toy manufacturers in the United States, of which 552 had
fewer than 500 employees and would be considered small entities
according to the Small Business Administration (SBA) criteria.\14\ Of
the small
[[Page 54761]]
manufacturers, 326 had fewer than five employees.
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\14\ 2012 County Business Patterns.
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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. Toy
wholesalers are classified in NAICS category 42392 (``Toy and Hobby
Goods and Supplies Merchant Wholesalers''). According to the U.S.
Bureau of the Census, there were 2,096 firms in this category.\15\ Of
these, 2,021 had fewer than 100 employees and would be considered small
businesses according to SBA criteria. Toy retailers are classified in
NAICS category 45112 (``Hobby, Toy, and Game Stores''). There could be
about 5,800 toy retailers that would meet the SBA criteria to be
considered a small entity.\16\ The number of these small toy retailers
that import toys, as opposed to obtaining their product from domestic
sources is not known.
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\15\ 2012 County Business Patterns.
\16\ The SBA considers a toy retailer (NAICS 45112) 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 2007, the average
receipts for toy manufacturers with more than 500 employees was
almost $500 million. The average receipts for the next largest
category for which summary data was published, toy retailers with at
least 100 but fewer than 500 employees were about $12 million. There
were 5,864 firms in this NAICS category, of which 5,839 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:
2007.)
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The phthalate regulations also apply 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. These include toddler beds, full
size and non-full size cribs, bassinets and cradles, bedside sleepers,
high chairs, hook-on-chairs, and booster seats. Other child care
articles include sleepwear, and crib or cradle bumpers. In its ongoing
market research, CPSC staff has identified 364 suppliers of these
products that would be considered small according to criteria
established by the SBA. 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.
Child care articles would also include products such as teethers
(if they are not medical devices), pacifiers, and bottle nipples.
Manufacturers of these products are classified in NAICS category 326299
(``All other rubber product manufacturing''). There are 617 firms
classified in this NAICS code of which 573 are considered to be
small.\17\ However, this NAICS category includes many other products
and most of these firms probably do not manufacture child care
articles.
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\17\ 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: 2011,'' 2011
County Business Patterns.
---------------------------------------------------------------------------
Although, as discussed above, the number of small companies that
supply children's toys or child care articles to the U.S. market might
be close to 10,000, the number that actually supply products with
accessible polyethylene, polypropylene, high impact polystyrene, or
acrylonitrile, butadiene styrene component parts is not known. Also not
known is the number of children's toys and child care articles that
contain these plastics. To develop comprehensive estimates of the
number of products that contain these plastics and the number of firms
that supply the products it would probably be necessary to survey a
representative sample of toy and child care article suppliers to
solicit information on their use of the four plastics or to collect a
representative sample of children's toys and child care articles and
analyze the accessible components to determine which ones contained one
or more of the four plastics.
Although comprehensive estimates of the number of children's toys
and child care articles that contain components made from the four
plastics are not available, there is some evidence that these plastics
are extensively used in children's toys. One source stated that
polypropylene and high density polyethylene are used in 38 and 25
percent, respectively, of injection molded toys. Low density
polyethylene and acrylonitrile butadiene styrene, are each used in less
than 10 percent of the injection molded toys. Polystyrene may also be
used in injection molded toys, but the source does not specify the
proportion that is high impact polystyrene.\18\ The Commission requests
comments to better determine the impact the proposed determinations
would have on small entities.
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\18\ Donald V. Rosato, Plastics End Use Applications, Springer,
New York, (2011).
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4. Reporting, Recordkeeping, and Other Compliance Requirements and
Impact on Small Businesses
The proposed rule would determine that there is a high degree of
assurance that four specific plastics with any of the accompanying
additives will not contain any prohibited phthalates at concentrations
above 0.1 percent prohibition level. As a result of the proposed
determinations, manufacturers, importers, and private labelers of
children's toys and child care articles that have accessible components
that consist of these plastics and any accompanying additives will not
have to obtain third party tests to certify that the accessible
components do not contain the prohibited phthalates in concentrations
above 0.1 percent.
The proposed rule would not impose any additional reporting,
recordkeeping, or other compliance requirements on small entities. In
fact, because the proposed rule would eliminate a testing requirement,
there would be a small reduction in some of the recordkeeping burden
under 16 CFR part 1107 and 16 CFR part 1109 because manufacturers would
no longer have to maintain records of third party phthalate tests for
the component parts manufactured from these four plastics.
A determination that specified plastics with accompanying additives
used in children's toys and child care articles do not require third
party testing is expected to be entirely beneficial to manufacturers
and importers using those plastics in accessible component parts
because manufacturers and importers could forego testing they otherwise
would be required to conduct. However, staff believes the magnitude of
that benefit is uncertain and could depend on factors such as:
The extent to which manufacturers have already reduced
their testing costs by using component part testing (as allowed in 16
CFR part 1109);
the volume of children's toys and child care articles that
contain PE, PP, HIPS, or ABS;
whether importers who certify children's products are
unsure what plastics are being used in the toys and child care articles
they import, so they could not take advantage of the determinations
without additional testing to assure that a component part is composed
of one of the four plastics.
The Commission welcomes comments on the potential impact of the
proposed rule on small entities. Comments are especially welcome on the
following topics:
The extent to which PP, PE, HIPS, or ABS 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;
[[Page 54762]]
Any situations or conditions in the proposed rule that
would make it difficult to make use of the determinations to reduce
third party testing costs; and
Although the Commission expects that the impact of the
proposed rule will be entirely beneficial, any potential negative
impacts of the proposed rule.
5. Other Federal Rules
We have not identified any Federal rules that duplicate or conflict
with the proposed rule.
6. 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 1308
Business and industry, Consumer protection, Imports, Infants and
children, Product testing and certification, Toys.
0
Accordingly, the Commission proposes to amend Title 16 of the Code of
Federal Regulations by adding part 1308 to read as follows:
PART 1308--PROHIBITION OF CHILDREN'S TOYS AND CHILD CARE ARTICLES
CONTAINING SPECIFIED PHTHALATES: DETERMINATIONS REGARDING CERTAIN
PLASTICS
Sec.
1308.1 Prohibited children's toys and child care articles containing
specified phthalates and testing requirements.
1308.2 Determinations for specified plastics.
Authority: Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C.
2063(d)(3)(B).
Sec. 1308.1 Prohibited children's toys and child care articles
containing specified phthalates and testing requirements.
Section 108(a) of the Consumer Product Safety Improvement Act of
2008 (CPSIA) permanently prohibits any children's toy or child care
article that contains concentrations of more than 0.1 percent of di-(2-
ethylhexl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl
phthalate (BBP). Section 108(b)(1) of the CPSIA prohibits on an interim
basis any children's toy that can be placed in a child's mouth or child
care article that contains concentrations of more than 0.1 percent of
diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl
phthalate (DnOP). Materials used in children's toys and child care
articles subject to section 108(a) and (b)(1) of the CPSIA must comply
with the third party testing requirements of section 14(a)(2) of the
Consumer Product Safety Act (CPSA), unless listed in Sec. 1308.2.
Sec. 1308.2 Determinations for specified plastics.
(a) The following plastics do not exceed the phthalates content
limits with a high degree of assurance as that term is defined in 16
CFR part 1107:
(1) Polypropylene (PP), with any of the following additives:
(i) The plasticizers polybutenes, dioctyl sebacate, paraffinic oil,
isooctyl tallate, mineral plasticizing oils, and polyol;
(ii) Hydrocarbon solvents;
(iii) Catalysts;
(iv) Fillers;
(v) Primary and secondary antioxidants;
(vi) Neutralizing agents;
(vii) Antistatic agents;
(viii) Slip agents;
(ix) Metal deactivators;
(x) Quenchers;
(xi) UV stabilizers;
(xii) Nucleating agents;
(xiii) Flame retardants;
(xiv) Blowing or foaming agents;
(xv) Antiblocking agents;
(xvi) Lubricants; or
(xvii) Colorants.
(2) Polyethylene (PE), with any of the following additives:
(i) The plasticizers glyceryl tribenzoate, polyethylene glycol,
sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM
rubber, and EVA polymer;
(ii) Initiators;
(iii) Promoters;
(iv) Catalysts;
(v) Fillers;
(vi) Antistatic agents;
(vii) Flame retardants;
(viii) Anti-blocking agents;
(ix) Slip agents;
(x) Blowing agents;
(xi) Ccross-linking agents;
(xii) Antioxidants;
(xiii) Carbon black; or
(xiv) Colorants.
(3) High-impact polystyrene (HIPS), with any of the following
additives:
(i) Catalysts;
(ii) Internal lubricants;
(iii) Chain transfer/transition agents;
(iv) Stabilizers;
(v) Diluents;
(vi) Colorants;
(vii) Aluminum chloride, ethyl chloride, hydrochloric acid;
(viii) Iron oxide, potassium oxide, chromium oxide; or
(ix) Bifunctional peroxides.
(4) Acrylonitrile butadiene styrene (ABS), with any of the
following additives:
(i) The plasticizers phosphate esters, long chain fatty acid esters
and aromatic sulfonamide;
(ii) Hydrocarbon solvents
(iii) Stabilizers;
(iv) Lubricants;
(v) Antioxidants;
(vi) Molecular weight regulators;
(vii) Initiators/catalysts,
(viii) Activators;
(ix) Emulsifiers; or
(x) Colorants.
(b) Accessible component parts of children's toys and child care
articles made with the specified plastics, and specified additives,
listed in paragraph (a) of this section are not required to be third
party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part
1107.
(c) Accessible component parts of children's toys and child care
articles made with a plastic or additives not listed in paragraph (a)
of this section are required to be third party tested pursuant to
section 14(a)(2) of the CPSA and 16 CFR part 1107.
Dated: August 11, 2016.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2016-19464 Filed 8-16-16; 8:45 am]
BILLING CODE 6355-01-P