Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41163 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(3) An AMOC that provides an acceptable 

level of safety may be used for any repair, 

modification, or alteration required by this 

AD if it is approved by the Boeing 

Commercial Airplanes Organization 

Designation Authorization (ODA) that has 

been authorized by the Manager, Los Angeles 

ACO Branch, to make those findings. To be 

approved, the repair method, modification 

deviation, or alteration deviation must meet 

the certification basis of the airplane, and the 

approval must specifically refer to this AD. 

(4) Except as required by paragraph (h) of 

this AD: For service information that 

contains steps that are labeled as Required 

for Compliance (RC), the provisions of 

paragraphs (k)(4)(i) and (k)(4)(ii) of this AD 

apply. 

(i) The steps labeled as RC, including 

substeps under an RC step and any figures 

identified in an RC step, must be done to 

comply with the AD. If a step or substep is 

labeled ‘‘RC Exempt,’’ then the RC 

requirement is removed from that step or 

substep. An AMOC is required for any 

deviations to RC steps, including substeps 

and identified figures. 

(ii) Steps not labeled as RC may be 

deviated from using accepted methods in 

accordance with the operator’s maintenance 

or inspection program without obtaining 

approval of an AMOC, provided the RC steps, 

including substeps and identified figures, can 

still be done as specified, and the airplane 

can be put back in an airworthy condition. 

(l) Related Information 

(1) For more information about this AD, 

contact George Garrido, Aerospace Engineer, 

Airframe Section, FAA, Los Angeles ACO 

Branch, 3960 Paramount Boulevard, 

Lakewood, CA 90712–4137; phone: 562–627– 

5232; fax: 562–627–5210; email: 

george.garrido@faa.gov. 

(2) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (m)(3) and (m)(4) of this AD. 

(m) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless the AD specifies otherwise. 

(i) Boeing Alert Service Bulletin MD80– 

53A316, dated December 15, 2016. 

(ii) Reserved. 

(3) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Contractual & Data 

Services (C&DS), 2600 Westminster Blvd., 

MC 110–SK57, Seal Beach, CA 90740–5600; 

telephone 562–797–1717; Internet https://

www.myboeingfleet.com. 

(4) You may view this service information 

at the FAA, Transport Standards Branch, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

(5) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on August 

17, 2017. 

Jeffrey E. Duven, 

Director, System Oversight Division, Aircraft 

Certification Service. 

[FR Doc. 2017–18165 Filed 8–29–17; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1308 

[Docket No. CPSC–2016–0017] 

Prohibition of Children’s Toys and 

Child Care Articles Containing 

Specified Phthalates: Determinations 

Regarding Certain Plastics 

AGENCY: U.S. Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: The Consumer Product Safety 

Commission (Commission, or CPSC) is 

issuing a final rule that determines that 

certain plastics with specified additives 

would not contain the specified 

phthalates prohibited in children’s toys 

and child care articles. Based on these 

determinations, the specified plastics 

with specified additives will not require 

third party testing for compliance with 

the mandatory prohibitions on 

children’s toys and child care articles 

containing phthalates. 

DATES: The rule is effective on 

September 29, 2017. 

FOR FURTHER INFORMATION CONTACT: John 

W. Boja, Lead Compliance Officer, 

Regulatory Enforcement, Office of 

Compliance and Field Operations, 

Consumer Product Safety Commission, 

4330 East West Highway Bethesda, MD 

20814–4408; telephone: 301–504–7300; 

email: jboja@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) amended the CPSA 

and directed the CPSC to seek comment 

on ‘‘opportunities to reduce the cost of 

third party testing requirements 

consistent with assuring compliance 

with any applicable consumer product 

safety rule, ban, standard, or 

regulation.’’ Public Law 112–28 also 

authorized the Commission to issue new 

or revised third party testing regulations 

if the Commission determines ‘‘that 

such regulations will reduce third party 

testing costs consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations.’’ 15 U.S.C. 

2063(d)(3)(B). 

2. Prohibitions in Section 108 of the 

CPSIA 

Section 108(a) of the CPSIA 

permanently prohibits the manufacture 

for sale, offer for sale, distribution in 

commerce, or importation into the 

United States of any ‘‘children’s toy or 

child care article’’ that contains 

concentrations of more than 0.1 percent 

of di(2-ethylhexyl) phthalate (DEHP), 

dibutyl phthalate (DBP), or butyl benzyl 

phthalate (BBP). 15 U.S.C. 2057c(a). 

Section 108(b)(1) prohibits on an 

interim basis (i.e., until the Commission 

promulgates a final rule), the 

manufacture for sale, offer for sale, 

distribution in commerce, or 

importation into the United States of 

‘‘any children’s toy that can be placed 

in a child’s mouth’’ or ‘‘child care 

article’’ containing concentrations of 

more than 0.1 percent of diisononyl 

phthalate (DINP), diisodecyl phthalate 

(DIDP), or di-n-octyl phthalate (DNOP). 

15 U.S.C. 2057c(b)(1). Children’s toys 

and child care articles subject to the 

content limits in section 108 of the 

CPSIA require third party testing for 

compliance with the phthalate content 

limits before the manufacturer can issue 

a Children’s Product Certificate (CPC) 

and enter the children’s toys or child 

care articles into commerce. 

The CPSIA required the Commission 

to appoint a Chronic Hazard Advisory 

Panel (CHAP) to ‘‘study the effects on 

children’s health of all phthalates and 

phthalate alternatives as used in 

children’s toys and child care articles.’’ 

15 U.S.C. 2057c(b)(2). The CHAP issued 

41164 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 

1http://www.cpsc.gov/PageFiles/169902/CHAPREPORT-With-Appendices.pdf. 

2https://www.federalregister.gov/articles/2014/ 

12/30/2014-29967/prohibition-of-childrens-toysand-child-care-articles-containing-specifiedphthalates. 

its report in July 2014.1 Based on the 

CHAP report, the Commission 

published a notice of proposed 

rulemaking (NPR),2 proposing to 

permanently prohibit children’s toys 

and child care articles containing 

concentrations of more than 0.1 percent 

of DINP, and proposing to lift the 

interim statutory prohibitions with 

respect to DIDP and DnOP. In addition, 

the NPR proposed adding four new 

phthalates, DIBP, DPENP, DHEXP, and 

DCHP, to the list of phthalates that 

cannot exceed 0.1 percent concentration 

in accessible component parts of 

children’s toys and child care articles. 

The Commission has not finalized its 

proposal on phthalates in children’s 

toys and child care articles. As the 

determinations NPR noted, the research 

providing the basis for the 

determinations covers the six phthalates 

subject to the statutory prohibition, as 

well as the additional phthalates the 

Commission proposed to prohibit in 

children’s toys and child care articles. 

This determinations final rule lists only 

the six phthalates subject to the 

statutory prohibition. However, when 

the Commission issues a final rule for 

the specified prohibited phthalates in 

children’s toys and child care articles, 

the Commission will revise the list of 

prohibited phthalates in children’s toys 

and child care articles to reflect the 

phthalates prohibited in the final rule. 

B. The Proposed Rule 

On August 17, 2016, the Commission 

published an NPR in the Federal 

Register, which proposed 

determinations that polypropylene (PP), 

polyethylene (PE), high-impact 

polystyrene (HIPS), and acrylonitrile 

butadiene styrene (ABS), with specified 

additives, would not contain the 

specified phthalates prohibited in 

children’s toys and child care articles. 

See 81 FR 54754. A determination 

means that third party testing of the 

specified plastics with specified 

additives is not required to demonstrate 

compliance with the phthalates 

prohibitions on children’s toys and 

child care articles. The NPR describes 

the CPSC’s contracts with Toxicology 

Excellence for Risk Assessment (TERA) 

to conduct research on phthalates and 

provide CPSC with two research reports 

on phthalates that are the primary basis 

for the determinations. 

C. Comments on the NPR 

CPSC received 11 comments on the 

NPR. Below, we summarize the key 

issues raised by the comments and 

provide responses. 

1. General and Technical Comments 

Some commenters express support for 

the proposed rule as a means to reduce 

third party testing costs. 

Comment 1: A commenter asserts that 

the proposed rule erroneously listed a 

catalyst as an additive. The commenter 

notes that a catalyst is not an additive 

and should not have been listed as such 

in the proposed rule. 

Response 1: The commenter is correct 

that a catalyst is not an additive, but 

rather, is used to accelerate chemical 

reactions, and therefore, is not intended 

to be an additive that provides a feature 

(e.g., color, flame resistance) to a plastic. 

However, plastic manufacturing 

processes can leave small amounts of 

catalyst in the resultant resin. These 

unrecovered catalysts can be considered 

trace materials or nonfunctional 

additives. Consequently, the 

Commission has changed ‘‘catalyst,’’ 

used in the text of the proposed rule, to 

‘‘unrecovered catalyst’’ in the text of the 

final rule, to more precisely identify any 

catalysts that remain in the plastic resin 

after manufacture. 

Comment 2: Commenters suggest 

several editorial changes to the Task 12 

report and the preamble of the final 

rule. The commenters suggested the 

following changes, among others, to the 

preamble of the rule: 

• Use ‘‘propylene’’ instead of ‘‘PP 

monomer’’; 

• Use ‘‘ethylene’’ instead of ‘‘PE 

monomer’’; 

• Note that many additives are not 

added to virgin PE, and not all additives 

will be included in most plastic used by 

manufacturers; 

• No longer list benzene as a raw 

material for HIPS; and 

• No longer state that Ziegler-Natta 

catalysts are not directly used in the 

production of HIPS. 

The commenters’ did not suggest 

changes to the codified text of the rule. 

Response 2: The Task 12 report is a 

completed work product that TERA 

produced under contract to the CPSC, 

and is not subject to modification. 

However, because the proposed rule 

was based on information in this report, 

and in the Task 11 report, we appreciate 

the technical comments and corrections. 

To the extent that the NPR relied on 

imprecise terminology, the preamble to 

the final rule uses the commenters’ 

suggested changes in terminology. The 

Commission notes that several of the 

suggested changes to the Task 12 report 

have no bearing on the rule, and as 

such, no changes to the preamble to the 

rule are necessary. 

Comment 3: A commenter suggests 

that the CPSC should list all the 

different types of plastics that qualify 

for a determination by their Chemical 

Abstracts Service Registry Number 

(CASRN) because the lack of this type 

of helpful guidance may lead to 

uncertainty and confusion over which 

plastics qualify for a determination. The 

commenter adds that many plastics 

have different types, not all of which 

may qualify for a determination that 

third party testing is not required. 

Response 3: The Task 11 and Task 12 

reports used both specific CASRNs and 

common chemical names (e.g., 

polyethylene, polypropylene, HIPS, and 

ABS). Therefore, CPSC considers that a 

CASRN or a common chemical name is 

acceptable for use as a plastic identifier 

because the contractor’s research 

indicates that none of the terms for the 

plastics researched showed that these 

plastics contain the specified phthalates 

in concentrations greater than 0.1 

percent. 

Suppliers may use the common name 

and not the CASRN to identify the 

plastics sold to component part 

manufacturers or children’s product 

manufacturers. Additionally, a rule 

listing only CASRNs could be 

unnecessarily restrictive, excluding 

versions of the specified plastics that are 

equally expected always to comply with 

the phthalates content limits. 

Conceivably, a plastic resin plus a 

specific combination of these additives 

could be assigned a unique CASRN, and 

would be excluded from using the third 

party testing determinations, if the 

determinations were limited to a 

defined set of CASRNs. 

2. Contamination Risk and Continued 

Testing 

Comment 4: A commenter states that 

molded plastics may become 

contaminated with phthalates if the 

molding machine used phthalatecontaining plastics and the molds were 

not cleaned before the new plastics were 

introduced. The commenter provides a 

theoretical example of polyvinyl 

chloride (PVC) production followed by 

production using one of the specified 

plastics. The commenter did not 

provide data regarding the possible 

levels of phthalate transfer. 

Another commenter states that hard 

plastics are at high risk of 

contamination with phthalates. The 

commenter asserts that they have 

measured the commenter has measured 

‘‘high’’ concentrations of phthalates on 

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41165 

ABS plastic during laboratory testing. 

The commenter did not provide any 

data or other specific information. 

Response 4: These commenters 

appear to describe contamination, not 

intentional use of the specified 

phthalates in the plastics that are the 

subject of the current determinations 

proceeding. Neither commenter 

provides information about 

manufacturing ABS or other plastics to 

contradict the findings in the Task 12 

report. Thus, we are unable to evaluate 

the commenters’ claim. 

Comment 5: A commenter suggests 

that the CPSC should conduct or 

procure ‘‘unbiased testing on the 

relevant plastics’’ to assure that none of 

the prohibited phthalates is present in 

the plastics. The commenter suggests 

that if CPSC does not conduct such 

testing, then the current third party 

testing requirements should be 

maintained. 

Response 5: The Commission’s 

determination that the specified plastics 

do not contain the specified phthalates 

at concentrations above 0.1 percent is 

based on data and information about 

raw materials and manufacturing 

processes that show that phthalates are 

not used to, or not present at, 

concentrations above 0.1 percent in the 

finished plastic. Staff has not conducted 

a study specifically to test products 

made with the specified plastics for the 

presence of the specified phthalates. 

However, staff’s experience with testing 

and screening of plastic products 

supports the conclusion, based on the 

raw material and manufacturing process 

information that the specified plastics 

do not contain the specified phthalates. 

The final rule is based on information 

about the use and production of 

phthalates and about the production of 

the specific plastics. Therefore, a testing 

study is not necessary. The information 

shows that phthalates are not used as 

plasticizers for the specified plastics 

and do not have other uses that would 

result in phthalate content in the 

plastics at levels exceeding the specified 

limit for children’s toys and child care 

articles. Thus, the final rule is not based 

on manufacturers’ choices or promises 

to use non-phthalate formulations, but 

rather, the rule is based on technical 

studies demonstrating that phthalates 

have no function or value in the 

specified plastics. 

3. Exclude Other Materials From 

Required Third Party Testing 

Comment 6: A commenter states that 

phthalates are incompatible with 

polyolefins, and that the phthalates’ cost 

will restrict their use to materials 

‘‘absolutely necessary to make certain 

materials flexible when this cannot be 

achieved by other means.’’ 

Response 6: We agree that the 

available information supports a 

determination that the polyolefins do 

not contain phthalates. The rule 

specifically includes determinations for 

the polyolefins, polyethylene, and 

polypropylene. 

Comment 7: A commenter 

recommends that the Commission 

include rigid vinyl in future 

assessments of whether specified 

plastics can be determined not to 

contain the specified phthalates in 

concentrations above 0.1 percent. The 

commenter states that rigid vinyl 

typically has a hardness of 70 or higher 

as measured using the Shore D 

durometer test method. 

Another commenter suggests that the 

final rule incorporate a provision that 

plastics meeting a hardness 

specification are exempt from third 

party testing requirements. According to 

the commenter, because rigid plastics’ 

hardness would be compromised by the 

addition of phthalates, plastics with 

Shore A hardness of 90 or greater are 

unlikely to contain any prohibited 

phthalate in concentrations above 0.1 

percent with a high degree of assurance. 

Response 7: The hardness of a plastic 

is not sufficient to determine the 

plastic’s compliance to the prohibitions 

in section 108 of the CPSIA. The Shore 

A and D hardness tests were never 

intended to be used as indicators of the 

presence of phthalates at low 

concentrations in plastics. As noted in 

Tab B of the staff’s briefing package, 

otherwise rigid plastics can be 

noncompliant with the 0.1 percent 

content limit for the specified 

phthalates. See https://www.cpsc.gov/ 

s3fs-public/Plastics-DeterminationsFinal-Rule-August-16-2017.pdf?

wF38T29pcl.Z5lMna6tu4Yo2H

xWEZwb5. 

Plasticized polyvinyl chloride (PVC) 

typically contains phthalates in 

concentrations up to 40 percent or more. 

‘‘Rigid’’ PVC has been shown to be 

noncompliant to the content limit of 0.1 

percent. Furthermore, PVC is often 

recycled into new PVC products. 

Recycling of PVC provides a path for 

plasticized PVC to be used in a new 

‘‘rigid’’ product that is noncompliant 

with the prohibitions in section 108 of 

the CPSIA. The determinations in the 

final rule for materials that do not, and 

will not, contain the specified 

phthalates at concentrations exceeding 

0.1 percent are based on information 

about raw materials and manufacturing 

processes. Physical characteristics about 

finished products are not sufficient 

information to indicate that a plastic 

complies with the prohibitions of 

section 108 of the CPSIA. 

Comment 8: Two commenters request 

that the CPSC exclude other plastic 

materials from required third party 

testing. The commenters request that the 

Commission determine that the 

materials in the following list do not 

contain any prohibited phthalates in 

concentrations above 0.1 percent, and 

thus, are not subject to third party 

testing for certification purposes, 

preferably by issuing a rule to that 

effect. The commenters provide no 

additional data to support the assertions 

that the materials on the list do not 

contain any prohibited phthalates: 

• 1,3,5-trioxane, copolymer with 1,3- 

dioxolane (acetal/polyoxymethylene 

(POM) copolymer) 

• 2,5-Furandione polymer with 1- 

propene (maleic anhydride grafted 

PP) 

• 2,5-Furandione polymer with ethane 

(maleic anhydride grafted PE) 

• Acetal/polyoxymethylene (POM) 

homopolymer 

• Acrylic (polymethylmethacrylate and 

polyacrylonitrile) 

• Ionomers 

• Liquid crystal polymers 

(hydroxybenzoic acid copolymers) 

• Nylon/polyamide 

• Olefin thermoplastic elastomers (such 

as EPDM) 

• Polybutene 

• Polybutylene terephthalate 

• Polycarbonate 

• Polyesters 

• Polyethylene terephthalate 

• Polylactic acid 

• Polyphenylene sulfide 

• Polystyrene, including crystal and 

general-purpose (GPPS), mediumimpact (MIPS) and super-high-impact 

(SHIPS) grades 

• Polytetramethylene glycol-dimethyl 

terephthalate-1,4-butanediol 

copolymer (polyester elastomer) 

• Silicone rubber (pure) 

• Styrene-butadiene copolymers 

• Styrene-butadiene-styrene rubbers 

(SBS/SBR) 

• Styrene-acrylonitrile copolymers 

(SAN) 

• Vinylidene chloride/methyl acrylate 

copolymers 

• CMYK Process Inks 

• Butadiene-ethylene resins 

• Butene-ethylene copolymers 

• Ethylene copolymers 

• Ethylene acrylic acid copolymers 

• Ethylene-propylene copolymers 

• Ethylene vinyl acetate copolymers 

• Ethylene vinyl acetate vinyl alcohol 

copolymers 

• Ethylene vinyl alcohol copolymers 

• Propylene-ethylene copolymers. 

41166 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 

3Exposure Assessment: Potential for the Presence 

of Phthalates in Specified Materials at 

Concentrations Above 0.1 Percent, Task Order 16, 

Contract Number CPSC–D–12–0001, August 8, 

2016, Final Report. Prepared by: Toxicology 

Excellence for Risk Assessment (TERA) University 

of Cincinnati. Available at: https://www.cpsc.gov/ 

s3fs-public/ 

ThePotentialforPhthalatesinSelectedPlastics.pdf. 

4Borealis, A.G. 2014. Polypropylene Products: 

Borealis’ Position on Phthalates in PP Catalysts. 

Vienna, Austria. Available at: http://

www.borealisgroup.com/Global/Company/ 

Sustainability/polypropylene-products.pdf. 

5Sastri, Vinny R., (2013). Plastics in Medical 

Devices: Properties, Requirements, and 

Applications. William Andrew, publisher, ISBN 

0323265634, 9780323265638. P 107. 

6 Ibid. 

7 Deanin, Rudolph D., Crugnola Aldo M. (1976). 

Toughness and Brittleness of Plastics. American 

Chemical Society, ISBN13: 9780841202214. eISBN: 

9780841223356. P239. 

One of these commenters specifically 

requests that the Commission extend the 

exclusion for high-impact polystyrene 

(HIPS) to crystal and general-purpose 

polystyrene (GPPS, or GPS), mediumimpact polystyrene (MIPS), and superhigh-impact polystyrene (SHIPS) grades. 

Another commenter urges the CPSC to 

continue to review other plastics for 

exemptions from required third party 

testing for phthalate content. Finally, a 

commenter suggests that the 

Commission allow suppliers of novel 

resin and additive combinations to 

warrant that the materials comply with 

the requirements of the CPSIA to a high 

degree of assurance. The commenter 

suggests that a third party testing 

exception could be granted based on 

‘‘demonstrated data.’’ 

Response 8: The commenters 

provided no information to support 

their claim that the plastics they listed 

do not contain phthalates as a part of 

their manufacture or as an additive. The 

Commission cannot make 

determinations without such 

information. 

However, after submission of the NPR 

to the Commission, CPSC’s contractor 

completed another report (the Task 16 

report), which included information 

about the additional polystyrene-based 

plastics, GPPS, MIPS, and SHIPS, 

mentioned by the commenter. 3 The 

Task 16 report contains information 

regarding the potential for GPPS, MIPS, 

SHIPS, and other plastics to contain any 

of the specified phthalates. 

Staff examined the Task 16 report and 

determined that GPPS, MIPS, SHIPS, 

and HIPS can be considered members of 

a family of polystyrene plastics. GPPS is 

the polystyrene component of HIPS, 

MIPS, and SHIPS, as described in the 

Task 12 and Task 16 reports. GPPS does 

not involve the use of phthalates in its 

manufacture, or as an additive. Because 

GPPS is brittle, polybutadiene rubber is 

added as a ‘‘shock absorber,’’ to increase 

the impact resistance of the polystyrenebutadiene mixture. In the manufacturing 

of polybutadiene, Ziegler-Natta 

catalysts, which can include DBP, DIBP, 

and DEHP, are used, raising the 

possibility that these phthalate 

components of the catalysts could 

remain in the processed plastics. 

However, catalysts are washed from the 

polybutadiene, and the remaining 

phthalate concentrations are not likely 

to exceed the 0.1 percent limit.4

Medium-impact polystyrene consists 

of GPPS with about two to five percent 

butadiene added.5 HIPS typically 

contains 6 to 12 percent butadiene.6 The 

concentration of butadiene in SHIPS 

ranges from 40 to 60 percent.7 All of 

these polystyrenes use the same 

materials as HIPS in their manufacture 

and use the same additives to achieve 

desired finished component part 

characteristics. 

The Task 16 report largely referred to 

the information about HIPS summarized 

in the previous Task 12 report because 

of the lack of additional references for 

the specific polystyrene materials and 

the similarities among the various 

polystyrene materials described in the 

general references. No specific reference 

in the Task 16 report identified the use 

of phthalates in production of GPPS, 

MIPS, HIPS, or SHIPS for consumer 

products. Additional research by staff 

did not discover any more information, 

suggesting that phthalates may be used 

to produce these polystyrene-based 

materials. 

Because the Task 12 and 16 reports 

and staff’s research show that phthalates 

are not used in GPPS, MIPS, and SHIPS 

(except as a catalyst to make the 

butadiene component), and the final 

concentration of phthalates in the 

polystyrene-based materials are likely to 

be well below 0.1 percent, the 

Commission agrees with the commenter 

that these materials can be included in 

the determination, along with HIPS. The 

codified text of the final rule adds 

GPPS, MIPS, and SHIPS to HIPS and the 

accompanying additives. 

Regarding the commenter’s suggestion 

to allow suppliers of novel resin and 

additive combinations to warrant that 

the materials comply with the 

requirements of the CPSIA, section 14 of 

the CPSA does not allow warrants to 

substitute for required third party 

testing. The Commission could consider 

determinations regarding third party 

testing requirements for new plastics or 

other materials in the future, if 

sufficient data and other information 

show that third party testing is not 

required to assure compliance. 

Currently, the Commission lacks those 

data. 

Comment 9: A commenter request 

that the Commission ‘‘publicly identify 

the many types of plastic materials that 

will not contain the restricted 

phthalates in excess of 0.1 percent and 

that can thus be excluded from thirdparty testing requirements.’’ The 

commenter also suggests that the 

Commission consider identifying the 

very few types of plastic materials that 

may contain the specified phthalates, 

and presumably, restrict required third 

party testing to those materials only. 

The commenter asserts that either 

approach would ‘‘offer added certainty 

to both testing laboratories and 

customers, of critical importance due to 

the high cost of phthalates testing.’’ 

Response 9: In this rulemaking, the 

Commission identifies several specific 

plastics that do not contain the specified 

phthalates in concentrations greater 

than 0.1 percent, based on information 

about raw materials, manufacturing 

processes, and other relevant factors. 

Any additional recommendations for 

determinations would similarly require 

data and other information to support a 

conclusion that the material does not, 

and will not, contain the specified 

phthalates. At this time, staff does not 

have evidence supporting additional 

plastics determinations, and therefore, 

the Commission cannot make 

determinations for additional plastics. 

Furthermore, although we understand 

the typical uses of phthalates and 

generally the types of products that may 

contain phthalates in concentrations 

exceeding 0.1 percent, we do not agree 

that specifying a list of products and 

materials that would have to be tested 

(as opposed to specifying materials that 

do not require testing to demonstrate 

conformance with the standard) is 

practical, given the range of materials 

that may contain phthalates and the 

possibility of future development of 

novel uses for the specified phthalates. 

4. Rule Contrary to CPSC 2009 

Statement of Policy and Public Law 

112–28 

Comment 10: A commenter asserts 

that the proposed rule is contrary to 

section 108(c) of the CPSIA (as amended 

by Pub. L. 112–28). The commenter 

points to a sentence in the proposed 

rule at § 1308.2(c): 

Accessible component parts of children’s 

toys and child care articles made with a 

plastic or additives not listed in paragraph (a) 

of this section are required to be third party 

tested pursuant to section 14(a)(2) of the 

CPSA and 16 CFR part 1107. 

Section 108(c) of the CPSIA states: 

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41167 

8https://cpsc.gov/s3fs-public/pdfs/blk_media_

componenttestingpolicy.pdf. 

9http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ 

ecfrbrowse/Title16/16cfr1109_main_02.tpl, Section 

1109.4 (g) states: ‘‘Due care means the degree of care 

that a prudent and competent person engaged in the 

same line of business or endeavor would exercise 

under similar circumstances. Due care does not 

permit willful ignorance.’’ 

APPLICATION.—Effective on the date of 

enactment of this Act, subsections (a) and 

(b)(1) and any rule promulgated under 

subsection (b)(3) shall apply to any 

plasticized component part of a children’s 

toy or child care article or any other 

component part of a children’s toy or child 

care article that is made of other materials 

that may contain phthalates. 

The commenter asserts that because 

this language limited required third 

party testing for phthalate content to 

accessible plasticized component parts, 

and to component parts that may 

contain phthalates, required third party 

testing is limited ‘‘to only component 

parts that have had a plasticizer added 

to it or to component parts that could 

contain phthalates.’’ The commenter 

adds that required third party testing is 

therefore not required for component 

parts that have not been plasticized and 

materials that may not contain 

phthalates. The commenter states that 

the aforementioned sentence in the 

proposed rule creates a new scope by 

applying required phthalate testing to 

all plastics not specifically listed in the 

determinations. 

The commenter suggests that the 

language in proposed § 1308.2(c) should 

state: 

Accessible component parts of children’s 

toys and child care articles made with a 

plastic or additives not listed in paragraph (a) 

of this section must still be comprised of 

compliant materials pursuant to section 108 

of CPSIA, Public Law 110–314 as amended 

by H.R. 2714, Public Law 112–28. 

The commenter asserts that this 

change to the language recommended 

above will reflect Congressional intent 

and be consistent with CPSC phthalate 

testing policy that has been effectively 

used by some companies to eliminate 

phthalate testing on materials known to 

be compliant. 

Response 10: The commenter is 

correct that section 108(c) of the CPSIA 

applies to this rule and that compliance 

to section 108 of the CPSIA is limited 

to plasticized component parts and 

other materials that may contain 

phthalates. As noted in the NPR 

preamble, children’s toys and child care 

articles are always required to comply 

with the requirements of section 108 of 

the CPSIA, regardless of any exceptions 

to required third party testing under 

section 14 of the CPSA. 

We acknowledge that § 1308.2(c) of 

the proposed rule could be interpreted 

as conflicting with section 108(c) of the 

CPSIA. Thus, we have revised 

§ 1308.2(c) in the final rule to clarify 

that the rule concerns accessible 

component parts of children’s toys and 

child care articles made from materials 

that are plasticized or may contain 

phthalates. 

We are making this change because, if 

a manufacturer or importer (i.e., a 

certifier) of a children’s toy or child care 

article has accessible component parts 

that have been plasticized, or are 

composed of a material that may contain 

phthalates, third party testing is 

required to assure compliance to section 

108 of the CPSIA. Examples of materials 

that may contain phthalates include, but 

are not limited to, plastics (for which a 

determination has not been made), inks, 

solvents, surface coatings, adhesives, 

and some rubberized materials. 

Comment 11: Two commenters claim 

that the NPR reverses the Commission’s 

2009 Statement of Policy, which, 

according to the commenters, lists a 

number of plastic materials other than 

the four plastics in the NPR that are not 

subject to third party testing for 

certification purposes. Another 

commenter states that the proposed rule 

‘‘appears to negate the flexibility 

afforded in the 2009 Statement of Policy 

document on phthalates.’’ The 

commenter suggests that ‘‘the flexibility 

granted by the CPSC’s Statement of 

Policy should be maintained.’’ The 

commenter asserts that this flexibility 

allows suppliers with supply chain 

knowledge to use their discretion when 

determining which materials to subject 

to third party testing. 

Response 11: The Commission’s 2009 

guidance document, Statement of 

Policy: Testing of Component Parts With 

Respect To Section 108 of the Consumer 

Product Safety Improvement Act,8 was 

intended to provide general guidance. It 

listed a number of materials that might 

not require third party testing. In 

contrast, the determination rule 

specifies that third party testing is not 

required for specified plastics with 

accompanying additives. The 

determination does not remove 

flexibility, but provides a clear pathway 

for manufacturers to know that third 

party testing is not required if they use 

the specific plastics and additives listed 

in the determination. 

5. Due Care and Certification 

Comment 12: A commenter suggests 

that the Commission state whether a 

Certificate of Compliance (COC) is 

required for plastics for which a third 

party testing determination has been 

made. The commenter states that if a 

COC is required when third party 

testing is not necessary, additional due 

diligence would be needed to ensure 

that the plastic material qualifies for a 

determination. The commenter suggests 

adding to the final rule a ‘‘due care’’ 

provision, similar to the provision in 16 

CFR part 1109 (the component part 

testing rule).9 The commenter contends 

that the due care requirement should 

apply to the phthalates determinations 

because of the inherent complexity 

involved with properly identifying the 

specific plastics and additives that 

would be exempt from testing. 

Another commenter states that 

importers often have limited knowledge 

of their products’ materials and lack the 

evidence to demonstrate compliance 

without testing. The commenter 

suggests that manufacturers use an 

Attenuated Total Reflectance (ATR) 

sensor to identify materials that do not 

contain prohibited phthalates. 

The commenter requested that the 

preamble clarify that manufacturers 

must use due diligence to ensure that 

their products only have plastics that 

are covered by the determination. The 

commenter states that screening tests, 

conducted on a first party basis, would 

reduce third party testing costs while 

ensuring compliance to the CPSIA. 

Response 12: The final rule addresses 

third party testing requirements for 

specified plastics to assure compliance 

to section 108 of the CPSIA. 

Certification of products subject to a 

children’s product safety rule is 

required, regardless of whether third 

party testing is required. A certifier or 

testing party must exercise due care to 

ensure that no action or inaction after 

testing, and before distribution in 

commerce, would affect compliance, 

including contamination or degradation, 

while a component part or finished 

product is in its custody. Thus, the 

component part testing rule establishes 

due care requirements for certifiers or 

testing parties. To repeat the 

requirements in this rule would be 

redundant and unnecessary. 

Comment 13: A commenter suggests 

that the final rule clarify that when 

certifying parties are relying on third 

party testing determinations for 

certification purposes, laboratories do 

not have the responsibility for: 

• Determining the type of plastic; 

• Verifying that the plastic is what a 

supplier declares; 

• Confirming that there has been no 

contamination; and 

41168 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 

10TERA Task 12 report, page 57. 11Tera Task 12 report, page 55. 

• Confirming there have been no 

material changes through supply chain 

traceability and production safeguards. 

The commenter asserts that these 

responsibilities reside with the 

certifying party (domestic manufacturer 

or importer). 

Response 13: We agree with the 

commenter that the manufacturer or 

importer of a children’s product is 

responsible for the product’s 

certification. Laboratories have limited 

responsibilities regarding certification 

issues. Unless a laboratory, on behalf of 

a manufacturer or importer, voluntarily 

chooses to be a children’s product or 

component part certifier, the laboratory 

is not responsible for the compliance of 

a tested product to the applicable 

children’s product safety rules. The 

manufacturer or importer is responsible 

for meeting the requirements of 16 CFR 

parts 1107 and 1109, which generally 

include the responsibilities listed by the 

commenter. 

6. Research Does Not Demonstrate High 

Degree of Assurance 

Comment 14: A commenter asserts 

that the research does not provide a 

high degree of assurance that the 

specified plastics do not contain any of 

the specified phthalates in 

concentrations above 0.1 percent 

because data are lacking on how 

phthalates are used, where they occur, 

and their migration. The commenter 

also expresses concern about phthalates 

in recycled materials. 

The commenter provides as examples: 

• The presence or concentration of 

the specified phthalates in polyethylene 

was not reported in TERA report. 

• Other studies cited in the Task 12 

report and patents for toys and child 

care products did not include 

information on the presence of 

phthalates in ABS.10

• Zeigler-Natta catalysts (which can 

contain the prohibited phthalates) could 

remain in high-impact polystyrene at a 

concentration of 0.0001 percent, but no 

test data had been supplied to support 

that claim. 

• There is a lack of information on 

phthalates in recycled plastics; and 

• Information on the possibility of a 

plastic’s contamination with a specified 

phthalate is also lacking. 

Response 14: CPSC disagrees with the 

assertion that data are lacking to support 

the determination. The available 

information identifies how and where 

phthalates are used, and also shows the 

chemicals and processes used to 

manufacture the specified plastics. 

Therefore, the Commission considers 

the available information provides 

support for the conclusion that the 

specified plastics do not contain 

phthalates at levels exceeding the 

specified limit for children’s toys and 

child care articles. 

We agree that few studies directly 

measured phthalate content in the 

specified plastics. However, we 

expected that such studies might be 

rare, given that the available 

information does not indicate that 

phthalates might be present. 

We acknowledge that the literature on 

recycling is not as extensive as the data 

on phthalates and plastics 

manufacturing. Nonetheless, we 

consider all of the information about 

phthalates’ use and occurrence to 

indicate that recycling could result in 

plastics that contain traces of 

phthalates. We expect that residual 

levels would be well below the 

maximum-allowed concentration in 

children’s toys and child care articles. 

In work done by a contractor and 

presented in the Task 12 and 16 reports, 

the contractor was faced with ‘‘proving 

a negative,’’ i.e., showing that phthalates 

are not present in the specified plastics. 

The contractor employed a tiered 

approach to research the specified 

plastics. This approach narrowed the 

field of possible sources and assisted in 

identifying information that was not 

available (data gaps) so that focused 

efforts could be directed in those areas. 

In the Task 12 report, from a ‘‘universe’’ 

of more than 109 million sources, the 

contractor screened 119,800 articles for 

relevant information on the four plastics 

and phthalates. The contractor states: 

Given the search strategy and its success at 

getting the other information, we can be 

confident that if there had been information 

on the phthalate content of the four plastics 

we would have found it. In fact, the 

consistent lack of information amongst the 

many places we searched, both secondary 

authoritative web and library sources and 

primary literature sources made us highly 

confident that there was very little 

information on the specified phthalates in 

the four plastics.11

In the Task 16 report, the contractor 

screened more than 179,000 sources for 

relevant information on the specified 

plastics and phthalates in a nonbiased 

manner that was representative of the 

world wide literature on this subject 

matter. As in the Task 12 report, the 

contractor states that its Task 16 report 

search strategy and its success at 

obtaining other information gives them 

confidence that, if there had been 

information on the phthalate content of 

the specified plastics, then they would 

have found it. 

Thus, for the reasons discussed above, 

CPSC considers the Task 12 and 16 

reports to provide a high degree of 

assurance that the specified plastics do 

not contain any prohibited phthalates in 

concentrations above 0.1 percent. 

Comment 15: A commenter 

recommends that the Commission 

exercise ‘‘extreme caution and 

skepticism with unproved claims of 

compliance with CPSC requirements.’’ 

The commenter expresses concern about 

unintentional or unknown factors that 

could result in the presence of 

phthalates. The commenter claims that 

many toys have disconnected and global 

supply chains, and that as a 

consequence, U.S. toy importers often 

rely on laboratory test results from 

foreign suppliers. The commenter cites 

the alleged failure of an importer to 

meet a state standard as evidence that 

CPSC should exercise caution and 

skepticism. 

Response 15: The rule is primarily 

based on information in the TERA Task 

11, 12, and 16 reports about use and 

production of phthalates, and about the 

production of specified plastics. The 

available information shows that 

phthalates are not used as plasticizers 

for the specified plastics, and are not 

otherwise found in the plastics at levels 

exceeding the specified limits for 

children’s toys and child care articles. 

The determinations in this rule are not 

based on suppliers’ assertions, 

manufacturer’s laboratory test results, or 

other industry attestations. We consider 

the information in the TERA Task 12 

and 16 reports, and the additional staff 

research, to be sufficient to make a 

determination with a high degree of 

assurance that the specified plastics are 

compliant with section 108 prohibitions 

without requiring third party testing. 

Regarding the commenter’s concerns 

about unintentional or unknown factors, 

we note that manufacturers and 

importers are required to have a high 

degree of assurance that their products 

are compliant to the applicable children 

product safety rules. Furthermore, 

manufacturers and importers are 

responsible for exercising due care to 

ensure their children’s products comply 

with the applicable children’s product 

safety rules. 16 CFR 1109.5(b)(3). 

Comment 16: A commenter states that 

the contractor (TERA) engaged by the 

CPSC to study phthalate use and 

investigate the presence of phthalates in 

four specified plastics may have a 

conflict of interest. The commenter 

notes TERA’s past litigation support for 

regulated industries. The commenter 

asserts TERA’s potential conflict of 

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41169 

12Approaches for describing and communicating 

overall uncertainty in toxicity characterizations: 

U.S. Environmental Protection Agency’s Integrated 

Risk Information System (IRIS) as a case study. The 

publication can be found at: https://

www.ncbi.nlm.nih.gov/pubmed/26827183. 

13Staff notes that after the contract work 

discussed here, TERA reorganized as the Risk 

Science Center at the University of Cincinnati: 

https://med.uc.edu/eh/centers/rsc. 

14The Merriam-Webster online dictionary defines 

a plasticizer as ‘‘a chemical added especially to 

rubbers and resins to impart flexibility, workability, 

or stretchability.’’ 

interest is exemplified in a 2016 paper 

sponsored by a chemical manufacturers’ 

trade group.12

The commenter adds that TERA is a 

founding member of the Alliance for 

Risk Assessment (ARA). The ARA’s 

Standing Panel includes the TERA 

founder, two industry consultants, 

employees of Dow Chemical and 

ExxonMobil, and two government 

employees. The commenter alleges that, 

in light of TERA’s relationship with 

ExxonMobil, TERA’s conclusions 

should be viewed with caution. 

Response 16: We consider TERA to be 

an independent organization 13 that 

focuses on advancing the science of 

toxicology and risk assessment. We do 

not agree that work by TERA or 

individual TERA staff in scientific 

projects, workshops, or publications 

concerning industrial chemicals or 

products or that include chemical firms, 

industry employees, or trade 

organizations necessarily indicates 

unreliable performance or improper 

influence in CPSC contract work. 

As standard procedure, CPSC reviews 

potential conflicts of interest before 

awarding a contract or task order. We 

did not identify any conflicts for TERA 

related to the investigation of the 

production and use of phthalates or the 

production of the specified plastics. 

We do not agree that the membership 

in ARA is evidence of a potential 

conflict of interest. Rather, we consider 

ARA to be a transparent, multistakeholder scientific collaboration to 

develop risk assessment information to 

advance public health activities. 

Furthermore, the commenter does not 

specify any projects by the ARA that 

suggest that the contracted TERA work 

is affected by potential conflicts of 

interest. 

In summary, the commenter did not 

provide any specific information that 

shows that the reports produced by 

TERA under contract with CPSC have 

been affected by potential conflicts of 

interest. Nor did the commenter show 

that the reports contain inaccurate or 

misleading data or information. 

7. Out of Scope Comments 

We also received comments on issues 

such as random spot checking for 

certificates of compliance, developing a 

procedure for petitioning the 

Commission for determinations, 

identifying statistical averaging and 

margins of error under which products 

could still be considered compliant, 

allowing other techniques beyond 

materials determinations for lead 

content testing that could reduce third 

party testing costs, asking Congress for 

authority to implement commenter’s 

suggestions, determinations for lead 

content, and the inclusion of supply 

chain controls when noncompliant 

products are found. This rulemaking is 

limited to determinations regarding 

phthalate content in specified plastics. 

The aforementioned comments are 

outside the scope of this rulemaking. 

D. Determinations for Specified Plastics 

With Certain Additives 

1. Legal Requirements for a 

Determination 

As noted above, section 14(a)(2) of the 

CPSA requires third party testing for 

children’s products that are subject to a 

children’s product safety rule. 15 U.S.C. 

2063(a)(2). Children’s toys and child 

care articles must comply with the 

phthalates prohibitions in section 108 of 

the CPSIA. 15 U.S.C. 2057c. In response 

to statutory direction, the Commission 

has investigated approaches that would 

reduce the burden of third party testing 

while also assuring compliance with 

CPSC requirements. As part of that 

endeavor, the Commission has 

considered whether certain materials 

used in children’s toys and child care 

articles would not require third party 

testing. 

To issue a determination that a plastic 

(including specified additives) does not 

require third party testing, the 

Commission must have sufficient 

evidence to conclude that the plastic 

and specified additives would 

consistently comply with the CPSC 

requirement to which the plastic (and 

specified additives) is subject so that 

third party testing is unnecessary to 

provide a high degree of assurance of 

compliance. Under 16 CFR 1107.2, ‘‘a 

high degree of assurance’’ is defined as 

‘‘an evidence-based demonstration of 

consistent performance of a product 

regarding compliance based on 

knowledge of a product and its 

manufacture.’’ 

For a material determination, a ‘‘high 

degree of assurance of compliance’’ 

means that the material will comply 

with the specified chemical limits due 

to the nature of the material or due to 

a processing technique that reduces the 

chemical concentration below its limit. 

For materials determined to comply 

with a chemical limit, the material must 

continue to comply with that limit if it 

is used in a children’s product subject 

to that requirement. A material on 

which a determination has been made 

cannot be altered or adulterated to 

render it noncompliant and then used in 

a children’s product. 

The determinations will only relieve 

the manufacturer’s obligation to have 

the specified plastics and accompanying 

additives tested by a CPSC-accepted 

third party conformity assessment body. 

Children’s toys and child care articles 

must still comply with the substantive 

phthalates content limits in section 108 

of the CPSIA, regardless of any relief 

from third party testing requirements. 

Additionally, the manufacturer must 

issue a certificate stating that the 

product complies with CPSC 

requirements. 

Phthalates are not naturally occurring 

materials, but are intentionally created 

and used in specific applications (e.g., 

plastics, surface coatings, solvents, inks, 

adhesives, and some rubberized 

materials). One application of 

phthalates in children’s toys and child 

care articles is as a plasticizer, or 

softener for plastic component parts.14

The addition of a plasticizer converts an 

otherwise rigid plastic into a more 

flexible form, such as in a child’s rubber 

duck or a soft plastic doll. Because 

plastics used in children’s toys and 

child care articles can contain the 

prohibited phthalates, third party 

testing is required before a CPC can be 

issued for children’s toys and child care 

articles with accessible plastic 

component parts. However, some 

specific plastics with certain additives 

might not use any of the prohibited 

phthalates as a plasticizer, or for any 

other purpose. For these specific 

plastics and accompanying additives, 

compliance with the requirements of 

section 108 of the CPSIA can be assured 

without requiring third party testing. To 

reduce the third party testing burden on 

children’s product certifiers while 

continuing to assure compliance, the 

CPSC has determined with a high 

degree of assurance that the specified 

plastics with certain additives comply 

with the phthalate content requirements 

of section 108 of the CPSIA, based on 

evidence indicating that such materials 

will not contain the prohibited 

phthalates. These determinations mean 

that third party testing for compliance 

with the phthalates prohibitions is not 

required for certification purposes for 

the specified four plastics. The 

Commission makes these 

41170 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 

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, as amended by the CPSIA, 

requires third party testing for 

children’s products subject to a 

children’s product safety rule. 15 U.S.C. 

2063(a)(2). Section 14(d)(3)(B) of the 

CPSA, as amended by Public Law 112– 

28, gives the Commission the authority 

to ‘‘prescribe new or revised third party 

testing regulations if it determines that 

such regulations will reduce third party 

testing costs consistent with assuring 

compliance with the applicable 

consumer product safety rules, bans, 

standards, and regulations.’’ Id. 

2063(d)(3)(B). These statutory 

provisions authorize the Commission to 

issue a rule determining that specified 

plastics and additives will not exceed 

the phthalates prohibitions of section 

108 of the CPSIA, and therefore, 

specified plastics do not require third 

party conformity assessment body 

testing to assure compliance with the 

phthalates limits in section 108 of the 

CPSIA. 

The determinations will relieve the 

specified plastics and accompanying 

additives from the third party testing 

requirement of section 14 of the CPSA 

to support the required certification. 

However, the determinations would not 

apply to any other plastic or additives 

beyond those listed in the rule. 

3. Description of the Final Rule 

The rule creates a new part 1308 for 

‘‘Prohibition of Children’s Toys and 

Child Care Articles Containing 

Specified Phthalates: Determinations 

Regarding Certain Plastics.’’ The rule 

determines that the specified plastics 

and accompanying additives do not 

contain the statutorily prohibited 

phthalates (DEHP, DBP, BBP, DINP, 

DIDP, DnOP) in concentrations above 

0.1 percent, and thus, are not required 

to be third party tested to assure 

compliance with section 108 of the 

CPSIA. 

Section 1308.1 of the rule explains the 

statutorily created requirements for 

children’s toys and child care articles 

under section 108 of the CPSIA and the 

third party testing requirements for 

children’s products. This section is 

unchanged from the proposed rule. As 

discussed in section A.2 of the 

preamble, currently, the agency is 

involved in rulemaking to determine 

whether to continue the interim 

prohibitions in section 108 and whether 

to prohibit any other children’s 

products containing any other 

phthalates. At the time of publication of 

this final rule in the Federal Register, 

the Commission has not issued a final 

rule in the phthalates rulemaking. 

Therefore, this determinations rule lists 

the phthalates that are statutorily 

prohibited from being in children’s toys 

and child care articles under section 108 

of the CPSIA. 

Section 1308.2(a) of the rule 

establishes the Commission’s 

determinations that the following seven 

plastics do not exceed the phthalates 

content limits with a ‘‘high degree of 

assurance’’ as that phrase is defined in 

16 CFR part 1107. Section 1308.2(a) of 

the rule is being finalized as proposed, 

except for the following changes. The 

final rule: 

• Adds ‘‘naphthenic oil’’ to the list of 

PP plasticizers in § 1308.2(a)(1)(i). 

Naphthenic oil is a nonphthalate 

plasticizer listed with paraffinic and 

mineral plasticizing oils in a Task 12 

report reference and should have been 

included in the proposed rule but was 

inadvertently omitted; 

• Adds the word ‘‘unrecovered’’ 

before ‘‘catalysts’’ in §§ 1308.2(a)(1)(iii), 

(a)(2)(iv), (a)(3)(i), (a)(4)(vii) of the final 

rule to clarify that this additive refers to 

small amounts of catalyst that may 

remain in a plastic resin after 

manufacture; 

• Adds general purpose polystyrene 

(GPPS), medium-impact polystyrene 

(MIPS), and super high-impact 

polystyrene (SHIPS) to § 1308.2(a)(3), to 

high-impact polystyrene (HIPS) that was 

listed in the proposed rule, to the list of 

materials that can be determined not to 

require third party testing in order to 

assure compliance with section 108 of 

the CPSIA. This change is made based 

on a commenter’s suggestion and 

supporting information from the Task 

16 report. These three plastics, along 

with HIPS, can be considered members 

of a family of polystyrene plastics 

manufactured with the same raw 

materials and processes. The potential 

additives for GPPS, MIPS, and SHIPS 

are the same as those for HIPS; 

• Replaces the term ‘‘phosphate 

esters’’ in § 1308.2(a)(4)(i) with 

‘‘hydrocarbon processing oil, triphenyl 

phosphate, resorcinol bis(diphenyl 

phosphate), and oligomeric phosphate’’ 

to more precisely identify the ABS 

plasticizers listed. The specific 

phosphate esters added were listed and 

discussed in the preamble of the NPR 

and the underlying staff briefing 

package, but were inadvertently left out 

of the codified text in the NPR; and 

• Deletes ‘‘hydrocarbon solvents’’ 

from the list of additives for PP in 

§ 1308.2(a)(1)(ii) and ABS in 

§ 1308.2(a)(4)(ii) because hydrocarbon 

solvents are not additives but rather are 

used in the production of resin. The list 

of additives in §§ 1308.2(a)(1)(ii) and 

(a)(4)(ii) has been renumbered to reflect 

this change. 

Section 1308.2(b) of the rule states 

that accessible component parts of 

children’s toys and child care articles 

made with the specified plastics, and 

specified additives listed in paragraph 

(a) of this section, are not required to be 

third party tested pursuant to section 

14(a)(2) of the CPSA and 16 CFR part 

1107. Section 1308.2(b) is included in 

the rule to make clear that when the 

listed plastics and accompanying 

additives are used in children’s toys and 

child care articles, manufacturers and 

importers are not required to conduct 

the third party testing required in 

section 14(a)(2) of the CPSA and 16 CFR 

part 1107. This provision is unchanged 

from the proposed rule. 

Section 1308.2(c) of the rule has been 

revised to add the phrase ‘‘that are 

plasticized or may contain phthalates’’ 

between ‘‘in paragraph (a) of this 

section’’ and ‘‘are required to be third 

party tested.’’ The new language tracks 

the statutory language of section 108(c) 

of the CPSIA regarding component parts 

of children’s toys or child care articles 

that are plasticized or may contain 

phthalates. If a manufacturer or 

importer (i.e., a certifier) of a children’s 

toy or child care article has accessible 

component parts that have been 

plasticized, or are composed of a 

material that may contain phthalates, 

third party testing is required to assure 

compliance to section 108 of the CPSIA. 

This change has been made because the 

language of § 1308.2(c) of the proposed 

rule could be interpreted as conflicting 

with section 108(c) of the CPSIA. 

E. Effective Date 

The Administrative Procedure Act 

(APA) generally requires that a 

substantive rule must be published not 

less than 30 days before its effective 

date. 5 U.S.C. 553(d)(1). The 

Commission proposed a 30-day effective 

date because the rule provides relief 

from existing testing requirements 

under the CPSIA. No comments were 

received regarding the effective date. 

The effective date for the rule is 30 days 

from the date of publication of the rule 

in in the Federal Register. 

Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41171 

15 Donald V. Rosato, Plastics End Use 

Applications, Springer, New York, (2011). 

16The cost estimates of third party phthalate 

testing are based on information provided both by 

consumer product manufacturers and by testing 

laboratories. 

F. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601–612, requires agencies to 

consider the impact of proposed and 

final rules on small entities, including 

small businesses. Section 604 of the 

RFA requires that agencies prepare a 

final regulatory flexibility analysis 

(FRFA) when promulgating final rules, 

unless the head of the agency certifies 

that the rule will not have a significant 

impact on a substantial number of small 

entities. The FRFA must describe the 

impact of the rule on small entities. 

CPSC staff prepared a FRFA. See Tab C 

of staff’s briefing package at https://

www.cpsc.gov/s3fs-public/PlasticsDeterminations-Final-Rule-August-16-

2017.pdf?wF38T29pcl.Z5lMna6tu4Y

o2HxWEZwb5. We provide a summary 

below. 

The rule is intended to reduce the 

burden of third party testing on 

manufacturers of children’s toys and 

child care articles consistent with 

assuring compliance with CPSC 

requirements under section 14 of the 

CPSA, as amended by section 2 of 

Public Law 112–28. The final rule 

would reduce the burden of third party 

testing on manufacturers and importers 

of children’s toys and child care articles 

by establishing determinations for 

certain plastics (PP, PE, GPPS, MIPS, 

HIPS, SHIPS, and ABS) and 

accompanying additives. Based on these 

determinations, the specified plastics 

with specified additives will not require 

third party testing for compliance with 

the mandatory prohibitions on 

children’s toys and child care articles 

containing phthalates. 

Although comprehensive estimates of 

the number of products that contain 

components made from the specified 

plastics are not available, there is some 

evidence that these plastics are 

extensively used in children’s toys. One 

source stated that polypropylene and 

high-density polyethylene are used in 

38 and 25 percent, respectively, of 

injection-molded toys.15 The same 

source also stated that low-density 

polyethylene, polystyrene, and 

acrylonitrile butadiene styrene, are each 

used in less than 10 percent of injectionmolded toys. 

Based on the number of domestic toy 

manufacturers that are classified as 

small businesses by the U.S. Bureau of 

the Census, and evidence that the 

specified plastics are used extensively 

in toys, staff believes a substantial 

number of small entities would be 

impacted positively by this regulation. 

The impact of the determinations on 

small businesses would be to reduce the 

burden of third party testing for 

phthalate content and would be 

expected to be entirely beneficial. The 

cost of third party testing for phthalates 

is between approximately $125 and 

$350 per test, depending on where the 

testing is conducted and any discounts 

that might be applicable.16 Because one 

product might have several component 

parts that require testing, the cost to test 

a finished product for phthalate content 

may be substantially higher. To the 

extent that small entities have lower 

production volumes than larger entities, 

these determinations would be expected 

to have a disproportionately beneficial 

impact on small entities because the 

costs of the tests are distributed over 

fewer units. Additionally, some 

laboratories may offer their larger 

customers discounts that might not be 

available to small entities that need 

fewer third party tests. However, the 

benefit of making the determinations 

could be less than might be expected. 

For example, some manufacturers might 

have already substantially reduced their 

third party phthalate testing costs by 

using the component part testing under 

16 CFR part 1109. Therefore, the 

marginal benefit that might be derived 

from making the determinations might 

be low. Some importers might not be 

certain of what materials are actually 

being used in each component part and 

might not be able to use the 

determinations without testing. 

Under section 604 of the Regulatory 

Flexibility Act, a FRFA should include 

a ‘‘statement of the factual, policy, and 

legal reasons for selecting the alternative 

adopted in the final rule and why each 

one of the other significant alternatives 

to the rule considered by the agency 

which affect the impact on small 

entities was rejected.’’ The final rule is 

itself, the result of CPSC’s efforts to 

reduce third party testing costs 

consistent with assuring compliance 

with all applicable consumer product 

safety rules. Therefore, CPSC considered 

few alternatives, other than expanding 

the list of plastics for which 

determinations could be made. We note 

that the final rule includes 

determinations for three additional 

polystyrenes (GPPS, MIPS, and SHIPS) 

that were not included in the NPR. 

G. Environmental Considerations 

The Commission’s regulations 

provide a categorical exclusion for 

Commission rules from any requirement 

to prepare an environmental assessment 

or an environmental impact statement 

because they ‘‘have little or no potential 

for affecting the human environment.’’ 

16 CFR 1021.5(c)(2). This rule falls 

within the categorical exclusion, so no 

environmental assessment or 

environmental impact statement is 

required. The Commission’s regulations 

state that safety standards for products 

normally have little or no potential for 

affecting the human environment. 16 

CFR 1021.5(c)(1). Nothing in this rule 

alters that expectation. 

List of Subjects in 16 CFR Part 1308 

Business and industry, Consumer 

protection, Imports, Infants and 

children, Product testing and 

certification, Toys. 

Accordingly, the Commission amends 

title 16 of the Code of Federal 

Regulations by adding part 1308 to read 

as follows: 

PART 1308—PROHIBITION OF 

CHILDREN’S TOYS AND CHILD CARE 

ARTICLES CONTAINING SPECIFIED 

PHTHALATES: DETERMINATIONS 

REGARDING CERTAIN PLASTICS 

Sec. 

1308.1 Prohibited children’s toys and child 

care articles containing specified 

phthalates and testing requirements. 

1308.2 Determinations for specified 

plastics. 

Authority: Sec. 3, Pub. L. 110–314, 122 

Stat. 3016; 15 U.S.C. 2063(d)(3)(B). 

§ 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. 

41172 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 

§ 1308.2 Determinations for specified 

plastics. 

(a) The following plastics do not 

exceed the phthalates content limits 

with a high degree of assurance as that 

term is defined in 16 CFR part 1107: 

(1) Polypropylene (PP), with any of 

the following additives: 

(i) The plasticizers polybutenes, 

dioctyl sebacate, isooctyl tallate, 

paraffinic, naphthenic, and mineral 

plasticizing oils, and polyol; 

(ii) Unrecovered catalysts; 

(iii) Fillers; 

(iv) Primary and secondary 

antioxidants; 

(v) Neutralizing agents; 

(vi) Antistatic agents; 

(vii) Slip agents; 

(viii) Metal deactivators; 

(ix) Quenchers; 

(x) UV stabilizers; 

(xi) Nucleating agents; 

(xii) Flame retardants; 

(xiii) Blowing or foaming agents; 

(xiv) Antiblocking agents; 

(xv) Lubricants; or 

(xvi) Colorants. 

(2) Polyethylene (PE), with any of the 

following additives: 

(i) The plasticizers glyceryl 

tribenzoate, polyethylene glycol, 

sunflower oil, paraffin wax, paraffin oil, 

mineral oil, glycerin, EPDM rubber, and 

EVA polymer; 

(ii) Initiators; 

(iii) Promoters; 

(iv) Unrecovered catalysts; 

(v) Fillers; 

(vi) Antistatic agents; 

(vii) Flame retardants; 

(viii) Anti-blocking agents; 

(ix) Slip agents; 

(x) Blowing agents; 

(xi) Cross-linking agents; 

(xii) Antioxidants; 

(xiii) Carbon black; or 

(xiv) Colorants. 

(3) General purpose polystyrene 

(GPPS), medium-impact polystyrene 

(MIPS), high-impact polystyrene (HIPS), 

and super high-impact polystyrene 

(SHIPS) with any of the following 

additives: 

(i) Unrecovered catalysts; 

(ii) Internal lubricants; 

(iii) Chain transfer/transition agents; 

(iv) Stabilizers; 

(v) Diluents; 

(vi) Colorants; 

(vii) Aluminum chloride, ethyl 

chloride, hydrochloric acid; 

(viii) Iron oxide, potassium oxide, 

chromium oxide; or 

(ix) Bifunctional peroxides. 

(4) Acrylonitrile butadiene styrene 

(ABS), with any of the following 

additives: 

(i) The plasticizers hydrocarbon 

processing oil, triphenyl phosphate, 

resorcinol bis(diphenyl phosphate), 

oligomeric phosphate, long chain fatty 

acid esters and aromatic sulfonamide; 

(ii) Stabilizers; 

(iii) Lubricants; 

(iv) Antioxidants; 

(v) Molecular weight regulators; 

(vi) Initiators/unrecovered catalysts, 

(vii) Activators; 

(viii) Emulsifiers; or 

(ix) Colorants. 

(b) Accessible component parts of 

children’s toys and child care articles 

made with the specified plastics, and 

specified additives, listed in paragraph 

(a) of this section are not required to be 

third party tested pursuant to section 

14(a)(2) of the CPSA and 16 CFR part 

1107. 

(c) Accessible component parts of 

children’s toys and child care articles 

made with a plastic or additives not 

listed in paragraph (a) of this section 

that are plasticized or may contain 

phthalates are required to be third party 

tested pursuant to section 14(a)(2) of the 

CPSA and 16 CFR part 1107. 

Dated: August 25, 2017. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2017–18387 Filed 8–29–17; 8:45 am] 

BILLING CODE 6355–01–P 

DEPARTMENT OF STATE 

22 CFR Part 121 

[Public Notice 10082] 

RIN 1400–AE43 

Temporary Modification of Category XI 

of the United States Munitions List 

AGENCY: Department of State. 

ACTION: Final rule; notice of temporary 

modification. 

SUMMARY: The Department of State, 

pursuant to its regulations and in the 

interest of the security of the United 

States, temporarily modifies Category XI 

of the United States Munitions List 

(USML). 

DATES: Amendatory instructions 1 and 2 

are effective August 30, 2017. 

Amendatory instruction No. 3 is 

effective August 30, 2018. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Robert Monjay, Office of Defense Trade 

Controls Policy, Department of State, 

telephone (202) 663–2817; email 

monjayr@state.gov. ATTN: Temporary 

Modification of Category XI. 

SUPPLEMENTARY INFORMATION: On July 1, 

2014, the Department published a final 

rule revising Category XI of the USML, 

79 FR 37536, effective December 30, 

2014. That final rule, consistent with 

the two prior proposed rules for USML 

Category XI (78 FR 45018, July 25, 2013 

and 77 FR 70958, November 28, 2012), 

revised paragraph (b) of Category XI to 

clarify the extent of control and 

maintain the existing scope of control 

on items described in paragraph (b) and 

the directly related software described 

in paragraph (d). The Department has 

determined that exporters may read the 

revised control language to exclude 

certain intelligence-analytics software 

that has been and remains controlled on 

the USML. Therefore, the Department 

determined that it is in the interest of 

the security of the United States to 

temporarily revise USML Category XI 

paragraph (b), pursuant to the 

provisions of 22 CFR 126.2, while a 

long-term solution is developed. The 

Department will publish any permanent 

revision to USML Category XI paragraph 

(b) addressing this issue as a proposed 

rule for public comment. 

This temporary revision clarifies that 

the scope of control in existence prior 

to December 30, 2014 for USML 

paragraph (b) and directly related 

software in paragraph (d) remains in 

effect. This clarification is achieved by 

reinserting the words ‘‘analyze and 

produce information from’’ and by 

adding software to the description of 

items controlled. 

The Department previously published 

a final rule on July 2, 2015 (80 FR 

37974) that temporarily modified USML 

Category XI(b) until December 29, 2015. 

The Department published a final rule 

on December 16, 2015 (80 FR 78130) 

that continued the July 2, 2015 

modification to August 30, 2017. This 

final rule extends the July 2, 2015 

modification to August 30, 2018 to 

allow the U.S. government to review 

USML Category XI in full and publish 

proposed and final rules. 

Regulatory Findings 

Administrative Procedure Act 

The Department is publishing this 

rule as a final rule based upon good 

cause, and its determination that 

delaying the effect of this rule during a 

period of public comment would be 

impractical, unnecessary and contrary 

to public interest. 5 U.S.C. 553(b)(3)(B). 

In addition, the Department is of the 

opinion that controlling the import and 

export of defense articles and services is 

a foreign affairs function of the United 

States Government and that rules 

implementing this function are exempt 

from sections 553 (rulemaking) and 554 

(adjudications) of the Administrative 

Procedure Act (APA).