Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41163
or lacking a principal inspector, the manager (5) You may view this service information certify that the product complies with of the local flight standards district office/ that is incorporated by reference at the all applicable CPSC-enforced certificate holding district office. National Archives and Records requirements. 15 U.S.C. 2063(a). For (3) An AMOC that provides an acceptable Administration (NARA). For information on level of safety may be used for any repair, the availability of this material at NARA, call children’s products, certification must modification, or alteration required by this 202–741–6030, or go to: http:// be based on testing conducted by a AD if it is approved by the Boeing www.archives.gov/federal-register/cfr/ibr- CPSC-accepted third party conformity Commercial Airplanes Organization locations.html. assessment body. Id. Public Law 112–28 Designation Authorization (ODA) that has Issued in Renton, Washington, on August (August 12, 2011) amended the CPSA been authorized by the Manager, Los Angeles 17, 2017. and directed the CPSC to seek comment ACO Branch, to make those findings. To be on ‘‘opportunities to reduce the cost of approved, the repair method, modification Jeffrey E. Duven, deviation, or alteration deviation must meet Director, System Oversight Division, Aircraft third party testing requirements the certification basis of the airplane, and the Certification Service. consistent with assuring compliance approval must specifically refer to this AD. [FR Doc. 2017–18165 Filed 8–29–17; 8:45 am] with any applicable consumer product (4) Except as required by paragraph (h) of BILLING CODE 4910–13–P safety rule, ban, standard, or this AD: For service information that regulation.’’ Public Law 112–28 also contains steps that are labeled as Required authorized the Commission to issue new for Compliance (RC), the provisions of paragraphs (k)(4)(i) and (k)(4)(ii) of this AD CONSUMER PRODUCT SAFETY or revised third party testing regulations apply. COMMISSION if the Commission determines ‘‘that (i) The steps labeled as RC, including such regulations will reduce third party substeps under an RC step and any figures 16 CFR Part 1308 testing costs consistent with assuring identified in an RC step, must be done to [Docket No. CPSC–2016–0017] compliance with the applicable comply with the AD. If a step or substep is consumer product safety rules, bans, labeled ‘‘RC Exempt,’’ then the RC Prohibition of Children’s Toys and requirement is removed from that step or standards, and regulations.’’ 15 U.S.C. substep. An AMOC is required for any Child Care Articles Containing 2063(d)(3)(B). Specified Phthalates: Determinations deviations to RC steps, including substeps 2. Prohibitions in Section 108 of the and identified figures. Regarding Certain Plastics (ii) Steps not labeled as RC may be CPSIA AGENCY: U.S. Consumer Product Safety deviated from using accepted methods in Section 108(a) of the CPSIA accordance with the operator’s maintenance Commission. or inspection program without obtaining ACTION: Final rule. permanently prohibits the manufacture approval of an AMOC, provided the RC steps, for sale, offer for sale, distribution in including substeps and identified figures, can SUMMARY: The Consumer Product Safety commerce, or importation into the still be done as specified, and the airplane Commission (Commission, or CPSC) is United States of any ‘‘children’s toy or can be put back in an airworthy condition. issuing a final rule that determines that child care article’’ that contains (l) Related Information certain plastics with specified additives concentrations of more than 0.1 percent would not contain the specified (1) For more information about this AD, of di(2-ethylhexyl) phthalate (DEHP), contact George Garrido, Aerospace Engineer, phthalates prohibited in children’s toys dibutyl phthalate (DBP), or butyl benzyl Airframe Section, FAA, Los Angeles ACO and child care articles. Based on these phthalate (BBP). 15 U.S.C. 2057c(a). Branch, 3960 Paramount Boulevard, determinations, the specified plastics Section 108(b)(1) prohibits on an Lakewood, CA 90712–4137; phone: 562–627– with specified additives will not require interim basis (i.e., until the Commission 5232; fax: 562–627–5210; email: third party testing for compliance with promulgates a final rule), the [email protected]. the mandatory prohibitions on manufacture for sale, offer for sale, (2) Service information identified in this children’s toys and child care articles distribution in commerce, or AD that is not incorporated by reference is containing phthalates. available at the addresses specified in importation into the United States of DATES: paragraphs (m)(3) and (m)(4) of this AD. The rule is effective on ‘‘any children’s toy that can be placed September 29, 2017. (m) Material Incorporated by Reference in a child’s mouth’’ or ‘‘child care FOR FURTHER INFORMATION CONTACT: John article’’ containing concentrations of (1) The Director of the Federal Register W. Boja, Lead Compliance Officer, approved the incorporation by reference more than 0.1 percent of diisononyl Regulatory Enforcement, Office of phthalate (DINP), diisodecyl phthalate (IBR) of the service information listed in this Compliance and Field Operations, paragraph under 5 U.S.C. 552(a) and 1 CFR (DIDP), or di-n-octyl phthalate (DNOP). Consumer Product Safety Commission, part 51. 15 U.S.C. 2057c(b)(1). Children’s toys 4330 East West Highway Bethesda, MD (2) You must use this service information and child care articles subject to the 20814–4408; telephone: 301–504–7300; as applicable to do the actions required by content limits in section 108 of the this AD, unless the AD specifies otherwise. email: [email protected]. CPSIA require third party testing for (i) Boeing Alert Service Bulletin MD80– SUPPLEMENTARY INFORMATION: 53A316, dated December 15, 2016. compliance with the phthalate content (ii) Reserved. A. Background limits before the manufacturer can issue (3) For service information identified in a Children’s Product Certificate (CPC) this AD, contact Boeing Commercial 1. Third Party Testing and Burden Reduction and enter the children’s toys or child Airplanes, Attention: Contractual & Data care articles into commerce. Services (C&DS), 2600 Westminster Blvd., Section 14(a) of the Consumer MC 110–SK57, Seal Beach, CA 90740–5600; Product Safety Act, (CPSA), as amended The CPSIA required the Commission telephone 562–797–1717; Internet https:// by the Consumer Product Safety to appoint a Chronic Hazard Advisory www.myboeingfleet.com. Panel (CHAP) to ‘‘study the effects on (4) You may view this service information Improvement Act of 2008 (CPSIA), requires that manufacturers of products children’s health of all phthalates and at the FAA, Transport Standards Branch, phthalate alternatives as used in 1601 Lind Avenue SW., Renton, WA. For subject to a consumer product safety information on the availability of this rule or similar rule, ban, standard, or children’s toys and child care articles.’’ material at the FAA, call 425–227–1221. regulation enforced by the CPSC, must 15 U.S.C. 2057c(b)(2). The CHAP issued
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 41164 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations
its report in July 2014.1 Based on the C. Comments on the NPR suggested changes to the Task 12 report CHAP report, the Commission CPSC received 11 comments on the have no bearing on the rule, and as published a notice of proposed NPR. Below, we summarize the key such, no changes to the preamble to the 2 rulemaking (NPR), proposing to issues raised by the comments and rule are necessary. Comment 3: A commenter suggests permanently prohibit children’s toys provide responses. and child care articles containing that the CPSC should list all the concentrations of more than 0.1 percent 1. General and Technical Comments different types of plastics that qualify of DINP, and proposing to lift the Some commenters express support for for a determination by their Chemical interim statutory prohibitions with the proposed rule as a means to reduce Abstracts Service Registry Number respect to DIDP and DnOP. In addition, third party testing costs. (CASRN) because the lack of this type the NPR proposed adding four new Comment 1: A commenter asserts that of helpful guidance may lead to uncertainty and confusion over which phthalates, DIBP, DPENP, DHEXP, and the proposed rule erroneously listed a plastics qualify for a determination. The DCHP, to the list of phthalates that catalyst as an additive. The commenter commenter adds that many plastics cannot exceed 0.1 percent concentration notes that a catalyst is not an additive have different types, not all of which in accessible component parts of and should not have been listed as such may qualify for a determination that children’s toys and child care articles. in the proposed rule. third party testing is not required. The Commission has not finalized its Response 1: The commenter is correct Response 3: The Task 11 and Task 12 proposal on phthalates in children’s that a catalyst is not an additive, but reports used both specific CASRNs and toys and child care articles. As the rather, is used to accelerate chemical common chemical names (e.g., determinations NPR noted, the research reactions, and therefore, is not intended polyethylene, polypropylene, HIPS, and providing the basis for the to be an additive that provides a feature ABS). Therefore, CPSC considers that a determinations covers the six phthalates (e.g., color, flame resistance) to a plastic. CASRN or a common chemical name is subject to the statutory prohibition, as However, plastic manufacturing acceptable for use as a plastic identifier well as the additional phthalates the processes can leave small amounts of because the contractor’s research Commission proposed to prohibit in catalyst in the resultant resin. These indicates that none of the terms for the children’s toys and child care articles. unrecovered catalysts can be considered plastics researched showed that these This determinations final rule lists only trace materials or nonfunctional plastics contain the specified phthalates the six phthalates subject to the additives. Consequently, the in concentrations greater than 0.1 statutory prohibition. However, when Commission has changed ‘‘catalyst,’’ percent. the Commission issues a final rule for used in the text of the proposed rule, to Suppliers may use the common name the specified prohibited phthalates in ‘‘unrecovered catalyst’’ in the text of the and not the CASRN to identify the children’s toys and child care articles, final rule, to more precisely identify any plastics sold to component part the Commission will revise the list of catalysts that remain in the plastic resin manufacturers or children’s product prohibited phthalates in children’s toys after manufacture. manufacturers. Additionally, a rule and child care articles to reflect the Comment 2: Commenters suggest listing only CASRNs could be phthalates prohibited in the final rule. several editorial changes to the Task 12 unnecessarily restrictive, excluding report and the preamble of the final versions of the specified plastics that are B. The Proposed Rule rule. The commenters suggested the equally expected always to comply with following changes, among others, to the On August 17, 2016, the Commission the phthalates content limits. preamble of the rule: Conceivably, a plastic resin plus a published an NPR in the Federal • Use ‘‘propylene’’ instead of ‘‘PP Register, which proposed specific combination of these additives monomer’’; could be assigned a unique CASRN, and determinations that polypropylene (PP), • Use ‘‘ethylene’’ instead of ‘‘PE polyethylene (PE), high-impact would be excluded from using the third monomer’’; party testing determinations, if the polystyrene (HIPS), and acrylonitrile • Note that many additives are not butadiene styrene (ABS), with specified determinations were limited to a added to virgin PE, and not all additives defined set of CASRNs. additives, would not contain the will be included in most plastic used by specified phthalates prohibited in manufacturers; 2. Contamination Risk and Continued children’s toys and child care articles. • No longer list benzene as a raw Testing See 81 FR 54754. A determination material for HIPS; and Comment 4: A commenter states that means that third party testing of the • No longer state that Ziegler-Natta molded plastics may become specified plastics with specified catalysts are not directly used in the contaminated with phthalates if the additives is not required to demonstrate production of HIPS. molding machine used phthalate- compliance with the phthalates The commenters’ did not suggest containing plastics and the molds were prohibitions on children’s toys and changes to the codified text of the rule. not cleaned before the new plastics were child care articles. The NPR describes Response 2: The Task 12 report is a introduced. The commenter provides a the CPSC’s contracts with Toxicology completed work product that TERA theoretical example of polyvinyl Excellence for Risk Assessment (TERA) produced under contract to the CPSC, chloride (PVC) production followed by to conduct research on phthalates and and is not subject to modification. production using one of the specified provide CPSC with two research reports However, because the proposed rule plastics. The commenter did not on phthalates that are the primary basis was based on information in this report, provide data regarding the possible for the determinations. and in the Task 11 report, we appreciate levels of phthalate transfer. the technical comments and corrections. Another commenter states that hard 1 http://www.cpsc.gov/PageFiles/169902/CHAP- To the extent that the NPR relied on plastics are at high risk of REPORT-With-Appendices.pdf. imprecise terminology, the preamble to contamination with phthalates. The 2 https://www.federalregister.gov/articles/2014/ 12/30/2014-29967/prohibition-of-childrens-toys- the final rule uses the commenters’ commenter asserts that they have and-child-care-articles-containing-specified- suggested changes in terminology. The measured the commenter has measured phthalates. Commission notes that several of the ‘‘high’’ concentrations of phthalates on
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41165
ABS plastic during laboratory testing. materials flexible when this cannot be complies with the prohibitions of The commenter did not provide any achieved by other means.’’ section 108 of the CPSIA. data or other specific information. Response 6: We agree that the Comment 8: Two commenters request Response 4: These commenters available information supports a that the CPSC exclude other plastic appear to describe contamination, not determination that the polyolefins do materials from required third party intentional use of the specified not contain phthalates. The rule testing. The commenters request that the phthalates in the plastics that are the specifically includes determinations for Commission determine that the subject of the current determinations the polyolefins, polyethylene, and materials in the following list do not proceeding. Neither commenter polypropylene. contain any prohibited phthalates in provides information about Comment 7: A commenter concentrations above 0.1 percent, and manufacturing ABS or other plastics to recommends that the Commission thus, are not subject to third party contradict the findings in the Task 12 include rigid vinyl in future testing for certification purposes, report. Thus, we are unable to evaluate assessments of whether specified preferably by issuing a rule to that the commenters’ claim. plastics can be determined not to effect. The commenters provide no Comment 5: A commenter suggests contain the specified phthalates in additional data to support the assertions that the CPSC should conduct or concentrations above 0.1 percent. The that the materials on the list do not procure ‘‘unbiased testing on the commenter states that rigid vinyl contain any prohibited phthalates: relevant plastics’’ to assure that none of typically has a hardness of 70 or higher • 1,3,5-trioxane, copolymer with 1,3- the prohibited phthalates is present in as measured using the Shore D dioxolane (acetal/polyoxymethylene the plastics. The commenter suggests durometer test method. (POM) copolymer) that if CPSC does not conduct such Another commenter suggests that the • 2,5-Furandione polymer with 1- testing, then the current third party final rule incorporate a provision that testing requirements should be plastics meeting a hardness propene (maleic anhydride grafted PP) maintained. specification are exempt from third • Response 5: The Commission’s party testing requirements. According to 2,5-Furandione polymer with ethane (maleic anhydride grafted PE) determination that the specified plastics the commenter, because rigid plastics’ • do not contain the specified phthalates hardness would be compromised by the Acetal/polyoxymethylene (POM) at concentrations above 0.1 percent is addition of phthalates, plastics with homopolymer • based on data and information about Shore A hardness of 90 or greater are Acrylic (polymethylmethacrylate and raw materials and manufacturing unlikely to contain any prohibited polyacrylonitrile) • processes that show that phthalates are phthalate in concentrations above 0.1 Ionomers • not used to, or not present at, percent with a high degree of assurance. Liquid crystal polymers concentrations above 0.1 percent in the Response 7: The hardness of a plastic (hydroxybenzoic acid copolymers) • finished plastic. Staff has not conducted is not sufficient to determine the Nylon/polyamide • a study specifically to test products plastic’s compliance to the prohibitions Olefin thermoplastic elastomers (such made with the specified plastics for the in section 108 of the CPSIA. The Shore as EPDM) • presence of the specified phthalates. A and D hardness tests were never Polybutene • However, staff’s experience with testing intended to be used as indicators of the Polybutylene terephthalate • and screening of plastic products presence of phthalates at low Polycarbonate • supports the conclusion, based on the concentrations in plastics. As noted in Polyesters • raw material and manufacturing process Tab B of the staff’s briefing package, Polyethylene terephthalate • information that the specified plastics otherwise rigid plastics can be Polylactic acid • do not contain the specified phthalates. noncompliant with the 0.1 percent Polyphenylene sulfide The final rule is based on information content limit for the specified • Polystyrene, including crystal and about the use and production of phthalates. See https://www.cpsc.gov/ general-purpose (GPPS), medium- phthalates and about the production of s3fs-public/Plastics-Determinations- impact (MIPS) and super-high-impact the specific plastics. Therefore, a testing Final-Rule-August-16-2017.pdf? (SHIPS) grades study is not necessary. The information wF38T29pcl.Z5lMna6tu4Yo2H • Polytetramethylene glycol-dimethyl shows that phthalates are not used as xWEZwb5. terephthalate-1,4-butanediol plasticizers for the specified plastics Plasticized polyvinyl chloride (PVC) copolymer (polyester elastomer) and do not have other uses that would typically contains phthalates in • Silicone rubber (pure) result in phthalate content in the concentrations up to 40 percent or more. • Styrene-butadiene copolymers plastics at levels exceeding the specified ‘‘Rigid’’ PVC has been shown to be • Styrene-butadiene-styrene rubbers limit for children’s toys and child care noncompliant to the content limit of 0.1 (SBS/SBR) articles. Thus, the final rule is not based percent. Furthermore, PVC is often • Styrene-acrylonitrile copolymers on manufacturers’ choices or promises recycled into new PVC products. (SAN) to use non-phthalate formulations, but Recycling of PVC provides a path for • Vinylidene chloride/methyl acrylate rather, the rule is based on technical plasticized PVC to be used in a new copolymers studies demonstrating that phthalates ‘‘rigid’’ product that is noncompliant • CMYK Process Inks have no function or value in the with the prohibitions in section 108 of • Butadiene-ethylene resins specified plastics. the CPSIA. The determinations in the • Butene-ethylene copolymers final rule for materials that do not, and • Ethylene copolymers 3. Exclude Other Materials From will not, contain the specified • Ethylene acrylic acid copolymers Required Third Party Testing phthalates at concentrations exceeding • Ethylene-propylene copolymers Comment 6: A commenter states that 0.1 percent are based on information • Ethylene vinyl acetate copolymers phthalates are incompatible with about raw materials and manufacturing • Ethylene vinyl acetate vinyl alcohol polyolefins, and that the phthalates’ cost processes. Physical characteristics about copolymers will restrict their use to materials finished products are not sufficient • Ethylene vinyl alcohol copolymers ‘‘absolutely necessary to make certain information to indicate that a plastic • Propylene-ethylene copolymers.
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 41166 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations
One of these commenters specifically phthalate concentrations are not likely required to assure compliance. requests that the Commission extend the to exceed the 0.1 percent limit.4 Currently, the Commission lacks those exclusion for high-impact polystyrene Medium-impact polystyrene consists data. (HIPS) to crystal and general-purpose of GPPS with about two to five percent Comment 9: A commenter request polystyrene (GPPS, or GPS), medium- butadiene added.5 HIPS typically that the Commission ‘‘publicly identify impact polystyrene (MIPS), and super- contains 6 to 12 percent butadiene.6 The the many types of plastic materials that high-impact polystyrene (SHIPS) grades. concentration of butadiene in SHIPS will not contain the restricted Another commenter urges the CPSC to ranges from 40 to 60 percent.7 All of phthalates in excess of 0.1 percent and continue to review other plastics for these polystyrenes use the same that can thus be excluded from third- exemptions from required third party materials as HIPS in their manufacture party testing requirements.’’ The testing for phthalate content. Finally, a and use the same additives to achieve commenter also suggests that the commenter suggests that the desired finished component part Commission consider identifying the Commission allow suppliers of novel characteristics. very few types of plastic materials that resin and additive combinations to The Task 16 report largely referred to may contain the specified phthalates, warrant that the materials comply with the information about HIPS summarized and presumably, restrict required third the requirements of the CPSIA to a high in the previous Task 12 report because party testing to those materials only. degree of assurance. The commenter of the lack of additional references for The commenter asserts that either suggests that a third party testing the specific polystyrene materials and approach would ‘‘offer added certainty exception could be granted based on the similarities among the various to both testing laboratories and ‘‘demonstrated data.’’ polystyrene materials described in the customers, of critical importance due to Response 8: The commenters general references. No specific reference the high cost of phthalates testing.’’ provided no information to support in the Task 16 report identified the use Response 9: In this rulemaking, the their claim that the plastics they listed of phthalates in production of GPPS, Commission identifies several specific do not contain phthalates as a part of MIPS, HIPS, or SHIPS for consumer plastics that do not contain the specified their manufacture or as an additive. The products. Additional research by staff phthalates in concentrations greater Commission cannot make did not discover any more information, than 0.1 percent, based on information determinations without such suggesting that phthalates may be used about raw materials, manufacturing information. to produce these polystyrene-based processes, and other relevant factors. However, after submission of the NPR materials. Any additional recommendations for to the Commission, CPSC’s contractor Because the Task 12 and 16 reports determinations would similarly require completed another report (the Task 16 and staff’s research show that phthalates data and other information to support a report), which included information are not used in GPPS, MIPS, and SHIPS conclusion that the material does not, about the additional polystyrene-based (except as a catalyst to make the and will not, contain the specified plastics, GPPS, MIPS, and SHIPS, butadiene component), and the final phthalates. At this time, staff does not mentioned by the commenter. 3 The concentration of phthalates in the have evidence supporting additional Task 16 report contains information polystyrene-based materials are likely to plastics determinations, and therefore, regarding the potential for GPPS, MIPS, be well below 0.1 percent, the the Commission cannot make SHIPS, and other plastics to contain any Commission agrees with the commenter determinations for additional plastics. Furthermore, although we understand of the specified phthalates. that these materials can be included in the typical uses of phthalates and Staff examined the Task 16 report and the determination, along with HIPS. The generally the types of products that may determined that GPPS, MIPS, SHIPS, codified text of the final rule adds contain phthalates in concentrations and HIPS can be considered members of GPPS, MIPS, and SHIPS to HIPS and the exceeding 0.1 percent, we do not agree a family of polystyrene plastics. GPPS is accompanying additives. that specifying a list of products and the polystyrene component of HIPS, Regarding the commenter’s suggestion materials that would have to be tested MIPS, and SHIPS, as described in the to allow suppliers of novel resin and (as opposed to specifying materials that Task 12 and Task 16 reports. GPPS does additive combinations to warrant that do not require testing to demonstrate not involve the use of phthalates in its the materials comply with the conformance with the standard) is manufacture, or as an additive. Because requirements of the CPSIA, section 14 of practical, given the range of materials GPPS is brittle, polybutadiene rubber is the CPSA does not allow warrants to that may contain phthalates and the added as a ‘‘shock absorber,’’ to increase substitute for required third party possibility of future development of the impact resistance of the polystyrene- testing. The Commission could consider novel uses for the specified phthalates. butadiene mixture. In the manufacturing determinations regarding third party of polybutadiene, Ziegler-Natta testing requirements for new plastics or 4. Rule Contrary to CPSC 2009 catalysts, which can include DBP, DIBP, other materials in the future, if Statement of Policy and Public Law and DEHP, are used, raising the sufficient data and other information 112–28 show that third party testing is not possibility that these phthalate Comment 10: A commenter asserts components of the catalysts could 4 that the proposed rule is contrary to remain in the processed plastics. Borealis, A.G. 2014. Polypropylene Products: Borealis’ Position on Phthalates in PP Catalysts. section 108(c) of the CPSIA (as amended However, catalysts are washed from the Vienna, Austria. Available at: http:// by Pub. L. 112–28). The commenter polybutadiene, and the remaining www.borealisgroup.com/Global/Company/ points to a sentence in the proposed Sustainability/polypropylene-products.pdf. rule at § 1308.2(c): 3 Exposure Assessment: Potential for the Presence 5 Sastri, Vinny R., (2013). Plastics in Medical of Phthalates in Specified Materials at Devices: Properties, Requirements, and Accessible component parts of children’s Concentrations Above 0.1 Percent, Task Order 16, Applications. William Andrew, publisher, ISBN toys and child care articles made with a Contract Number CPSC–D–12–0001, August 8, 0323265634, 9780323265638. P 107. plastic or additives not listed in paragraph (a) 2016, Final Report. Prepared by: Toxicology 6 Ibid. of this section are required to be third party Excellence for Risk Assessment (TERA) University 7 Deanin, Rudolph D., Crugnola Aldo M. (1976). tested pursuant to section 14(a)(2) of the of Cincinnati. Available at: https://www.cpsc.gov/ Toughness and Brittleness of Plastics. American CPSA and 16 CFR part 1107. s3fs-public/ Chemical Society, ISBN13: 9780841202214. eISBN: ThePotentialforPhthalatesinSelectedPlastics.pdf. 9780841223356. P239. Section 108(c) of the CPSIA states:
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41167
APPLICATION.—Effective on the date of that are plasticized or may contain determination. The commenter suggests enactment of this Act, subsections (a) and phthalates. adding to the final rule a ‘‘due care’’ (b)(1) and any rule promulgated under We are making this change because, if provision, similar to the provision in 16 subsection (b)(3) shall apply to any a manufacturer or importer (i.e., a CFR part 1109 (the component part plasticized component part of a children’s certifier) of a children’s toy or child care 9 toy or child care article or any other testing rule). The commenter contends component part of a children’s toy or child article has accessible component parts that the due care requirement should care article that is made of other materials that have been plasticized, or are apply to the phthalates determinations that may contain phthalates. composed of a material that may contain because of the inherent complexity phthalates, third party testing is involved with properly identifying the The commenter asserts that because required to assure compliance to section specific plastics and additives that this language limited required third 108 of the CPSIA. Examples of materials would be exempt from testing. party testing for phthalate content to that may contain phthalates include, but Another commenter states that accessible plasticized component parts, are not limited to, plastics (for which a and to component parts that may importers often have limited knowledge determination has not been made), inks, of their products’ materials and lack the contain phthalates, required third party solvents, surface coatings, adhesives, testing is limited ‘‘to only component evidence to demonstrate compliance and some rubberized materials. without testing. The commenter parts that have had a plasticizer added Comment 11: Two commenters claim suggests that manufacturers use an to it or to component parts that could that the NPR reverses the Commission’s Attenuated Total Reflectance (ATR) contain phthalates.’’ The commenter 2009 Statement of Policy, which, sensor to identify materials that do not adds that required third party testing is according to the commenters, lists a contain prohibited phthalates. therefore not required for component number of plastic materials other than parts that have not been plasticized and the four plastics in the NPR that are not The commenter requested that the materials that may not contain subject to third party testing for preamble clarify that manufacturers phthalates. The commenter states that certification purposes. Another must use due diligence to ensure that the aforementioned sentence in the commenter states that the proposed rule their products only have plastics that proposed rule creates a new scope by ‘‘appears to negate the flexibility are covered by the determination. The applying required phthalate testing to afforded in the 2009 Statement of Policy commenter states that screening tests, all plastics not specifically listed in the document on phthalates.’’ The conducted on a first party basis, would determinations. commenter suggests that ‘‘the flexibility reduce third party testing costs while The commenter suggests that the granted by the CPSC’s Statement of ensuring compliance to the CPSIA. language in proposed § 1308.2(c) should Policy should be maintained.’’ The Response 12: The final rule addresses state: commenter asserts that this flexibility third party testing requirements for specified plastics to assure compliance Accessible component parts of children’s allows suppliers with supply chain toys and child care articles made with a knowledge to use their discretion when to section 108 of the CPSIA. plastic or additives not listed in paragraph (a) determining which materials to subject Certification of products subject to a of this section must still be comprised of to third party testing. children’s product safety rule is compliant materials pursuant to section 108 Response 11: The Commission’s 2009 required, regardless of whether third of CPSIA, Public Law 110–314 as amended guidance document, Statement of party testing is required. A certifier or by H.R. 2714, Public Law 112–28. Policy: Testing of Component Parts With testing party must exercise due care to The commenter asserts that this Respect To Section 108 of the Consumer ensure that no action or inaction after 8 change to the language recommended Product Safety Improvement Act, was testing, and before distribution in above will reflect Congressional intent intended to provide general guidance. It commerce, would affect compliance, and be consistent with CPSC phthalate listed a number of materials that might including contamination or degradation, testing policy that has been effectively not require third party testing. In while a component part or finished used by some companies to eliminate contrast, the determination rule product is in its custody. Thus, the phthalate testing on materials known to specifies that third party testing is not component part testing rule establishes be compliant. required for specified plastics with due care requirements for certifiers or testing parties. To repeat the Response 10: The commenter is accompanying additives. The requirements in this rule would be correct that section 108(c) of the CPSIA determination does not remove redundant and unnecessary. applies to this rule and that compliance flexibility, but provides a clear pathway to section 108 of the CPSIA is limited for manufacturers to know that third Comment 13: A commenter suggests to plasticized component parts and party testing is not required if they use that the final rule clarify that when other materials that may contain the specific plastics and additives listed certifying parties are relying on third phthalates. As noted in the NPR in the determination. party testing determinations for preamble, children’s toys and child care 5. Due Care and Certification certification purposes, laboratories do not have the responsibility for: articles are always required to comply Comment 12: A commenter suggests with the requirements of section 108 of • Determining the type of plastic; that the Commission state whether a • the CPSIA, regardless of any exceptions Certificate of Compliance (COC) is Verifying that the plastic is what a to required third party testing under required for plastics for which a third supplier declares; section 14 of the CPSA. party testing determination has been • Confirming that there has been no We acknowledge that § 1308.2(c) of made. The commenter states that if a contamination; and the proposed rule could be interpreted COC is required when third party as conflicting with section 108(c) of the testing is not necessary, additional due 9 http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ CPSIA. Thus, we have revised diligence would be needed to ensure ecfrbrowse/Title16/16cfr1109_main_02.tpl, Section § 1308.2(c) in the final rule to clarify 1109.4 (g) states: ‘‘Due care means the degree of care that the plastic material qualifies for a that a prudent and competent person engaged in the that the rule concerns accessible same line of business or endeavor would exercise component parts of children’s toys and 8 https://cpsc.gov/s3fs-public/pdfs/blk_media_ under similar circumstances. Due care does not child care articles made from materials componenttestingpolicy.pdf. permit willful ignorance.’’
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 41168 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations
• Confirming there have been no the available information provides the specified plastics, then they would material changes through supply chain support for the conclusion that the have found it. traceability and production safeguards. specified plastics do not contain Thus, for the reasons discussed above, The commenter asserts that these phthalates at levels exceeding the CPSC considers the Task 12 and 16 responsibilities reside with the specified limit for children’s toys and reports to provide a high degree of certifying party (domestic manufacturer child care articles. assurance that the specified plastics do or importer). We agree that few studies directly not contain any prohibited phthalates in Response 13: We agree with the measured phthalate content in the concentrations above 0.1 percent. commenter that the manufacturer or specified plastics. However, we Comment 15: A commenter importer of a children’s product is expected that such studies might be recommends that the Commission responsible for the product’s rare, given that the available exercise ‘‘extreme caution and certification. Laboratories have limited information does not indicate that skepticism with unproved claims of responsibilities regarding certification phthalates might be present. compliance with CPSC requirements.’’ The commenter expresses concern about issues. Unless a laboratory, on behalf of We acknowledge that the literature on unintentional or unknown factors that a manufacturer or importer, voluntarily recycling is not as extensive as the data could result in the presence of chooses to be a children’s product or on phthalates and plastics component part certifier, the laboratory phthalates. The commenter claims that manufacturing. Nonetheless, we many toys have disconnected and global is not responsible for the compliance of consider all of the information about a tested product to the applicable supply chains, and that as a phthalates’ use and occurrence to consequence, U.S. toy importers often children’s product safety rules. The indicate that recycling could result in manufacturer or importer is responsible rely on laboratory test results from plastics that contain traces of foreign suppliers. The commenter cites for meeting the requirements of 16 CFR phthalates. We expect that residual parts 1107 and 1109, which generally the alleged failure of an importer to levels would be well below the meet a state standard as evidence that include the responsibilities listed by the maximum-allowed concentration in commenter. CPSC should exercise caution and children’s toys and child care articles. skepticism. 6. Research Does Not Demonstrate High In work done by a contractor and Response 15: The rule is primarily Degree of Assurance presented in the Task 12 and 16 reports, based on information in the TERA Task Comment 14: A commenter asserts the contractor was faced with ‘‘proving 11, 12, and 16 reports about use and that the research does not provide a a negative,’’ i.e., showing that phthalates production of phthalates, and about the high degree of assurance that the are not present in the specified plastics. production of specified plastics. The specified plastics do not contain any of The contractor employed a tiered available information shows that the specified phthalates in approach to research the specified phthalates are not used as plasticizers concentrations above 0.1 percent plastics. This approach narrowed the for the specified plastics, and are not because data are lacking on how field of possible sources and assisted in otherwise found in the plastics at levels phthalates are used, where they occur, identifying information that was not exceeding the specified limits for and their migration. The commenter available (data gaps) so that focused children’s toys and child care articles. also expresses concern about phthalates efforts could be directed in those areas. The determinations in this rule are not in recycled materials. In the Task 12 report, from a ‘‘universe’’ based on suppliers’ assertions, The commenter provides as examples: of more than 109 million sources, the manufacturer’s laboratory test results, or • The presence or concentration of contractor screened 119,800 articles for other industry attestations. We consider the specified phthalates in polyethylene relevant information on the four plastics the information in the TERA Task 12 was not reported in TERA report. and phthalates. The contractor states: and 16 reports, and the additional staff • Other studies cited in the Task 12 Given the search strategy and its success at research, to be sufficient to make a report and patents for toys and child getting the other information, we can be determination with a high degree of care products did not include confident that if there had been information assurance that the specified plastics are information on the presence of on the phthalate content of the four plastics compliant with section 108 prohibitions phthalates in ABS.10 we would have found it. In fact, the without requiring third party testing. • Zeigler-Natta catalysts (which can consistent lack of information amongst the Regarding the commenter’s concerns contain the prohibited phthalates) could many places we searched, both secondary about unintentional or unknown factors, remain in high-impact polystyrene at a authoritative web and library sources and we note that manufacturers and primary literature sources made us highly importers are required to have a high concentration of 0.0001 percent, but no confident that there was very little test data had been supplied to support information on the specified phthalates in degree of assurance that their products that claim. the four plastics.11 are compliant to the applicable children • There is a lack of information on product safety rules. Furthermore, phthalates in recycled plastics; and In the Task 16 report, the contractor manufacturers and importers are • Information on the possibility of a screened more than 179,000 sources for responsible for exercising due care to plastic’s contamination with a specified relevant information on the specified ensure their children’s products comply phthalate is also lacking. plastics and phthalates in a nonbiased with the applicable children’s product Response 14: CPSC disagrees with the manner that was representative of the safety rules. 16 CFR 1109.5(b)(3). assertion that data are lacking to support world wide literature on this subject Comment 16: A commenter states that the determination. The available matter. As in the Task 12 report, the the contractor (TERA) engaged by the information identifies how and where contractor states that its Task 16 report CPSC to study phthalate use and phthalates are used, and also shows the search strategy and its success at investigate the presence of phthalates in chemicals and processes used to obtaining other information gives them four specified plastics may have a manufacture the specified plastics. confidence that, if there had been conflict of interest. The commenter Therefore, the Commission considers information on the phthalate content of notes TERA’s past litigation support for regulated industries. The commenter 10 TERA Task 12 report, page 57. 11 Tera Task 12 report, page 55. asserts TERA’s potential conflict of
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41169
interest is exemplified in a 2016 paper Commission for determinations, is used in a children’s product subject sponsored by a chemical manufacturers’ identifying statistical averaging and to that requirement. A material on trade group.12 margins of error under which products which a determination has been made The commenter adds that TERA is a could still be considered compliant, cannot be altered or adulterated to founding member of the Alliance for allowing other techniques beyond render it noncompliant and then used in Risk Assessment (ARA). The ARA’s materials determinations for lead a children’s product. Standing Panel includes the TERA content testing that could reduce third The determinations will only relieve founder, two industry consultants, party testing costs, asking Congress for the manufacturer’s obligation to have employees of Dow Chemical and authority to implement commenter’s the specified plastics and accompanying ExxonMobil, and two government suggestions, determinations for lead additives tested by a CPSC-accepted employees. The commenter alleges that, content, and the inclusion of supply third party conformity assessment body. in light of TERA’s relationship with chain controls when noncompliant Children’s toys and child care articles ExxonMobil, TERA’s conclusions products are found. This rulemaking is must still comply with the substantive should be viewed with caution. limited to determinations regarding phthalates content limits in section 108 Response 16: We consider TERA to be phthalate content in specified plastics. of the CPSIA, regardless of any relief an independent organization 13 that The aforementioned comments are from third party testing requirements. focuses on advancing the science of outside the scope of this rulemaking. Additionally, the manufacturer must toxicology and risk assessment. We do issue a certificate stating that the not agree that work by TERA or D. Determinations for Specified Plastics product complies with CPSC individual TERA staff in scientific With Certain Additives requirements. projects, workshops, or publications 1. Legal Requirements for a Phthalates are not naturally occurring concerning industrial chemicals or Determination materials, but are intentionally created products or that include chemical firms, and used in specific applications (e.g., As noted above, section 14(a)(2) of the industry employees, or trade plastics, surface coatings, solvents, inks, CPSA requires third party testing for organizations necessarily indicates adhesives, and some rubberized children’s products that are subject to a unreliable performance or improper materials). One application of children’s product safety rule. 15 U.S.C. influence in CPSC contract work. phthalates in children’s toys and child 2063(a)(2). Children’s toys and child As standard procedure, CPSC reviews care articles is as a plasticizer, or care articles must comply with the potential conflicts of interest before softener for plastic component parts.14 phthalates prohibitions in section 108 of awarding a contract or task order. We The addition of a plasticizer converts an the CPSIA. 15 U.S.C. 2057c. In response did not identify any conflicts for TERA otherwise rigid plastic into a more to statutory direction, the Commission related to the investigation of the flexible form, such as in a child’s rubber has investigated approaches that would production and use of phthalates or the duck or a soft plastic doll. Because reduce the burden of third party testing production of the specified plastics. plastics used in children’s toys and We do not agree that the membership while also assuring compliance with child care articles can contain the in ARA is evidence of a potential CPSC requirements. As part of that prohibited phthalates, third party conflict of interest. Rather, we consider endeavor, the Commission has testing is required before a CPC can be ARA to be a transparent, multi- considered whether certain materials issued for children’s toys and child care stakeholder scientific collaboration to used in children’s toys and child care articles with accessible plastic develop risk assessment information to articles would not require third party component parts. However, some advance public health activities. testing. specific plastics with certain additives Furthermore, the commenter does not To issue a determination that a plastic might not use any of the prohibited specify any projects by the ARA that (including specified additives) does not suggest that the contracted TERA work require third party testing, the phthalates as a plasticizer, or for any is affected by potential conflicts of Commission must have sufficient other purpose. For these specific interest. evidence to conclude that the plastic plastics and accompanying additives, In summary, the commenter did not and specified additives would compliance with the requirements of provide any specific information that consistently comply with the CPSC section 108 of the CPSIA can be assured shows that the reports produced by requirement to which the plastic (and without requiring third party testing. To TERA under contract with CPSC have specified additives) is subject so that reduce the third party testing burden on been affected by potential conflicts of third party testing is unnecessary to children’s product certifiers while interest. Nor did the commenter show provide a high degree of assurance of continuing to assure compliance, the that the reports contain inaccurate or compliance. Under 16 CFR 1107.2, ‘‘a CPSC has determined with a high misleading data or information. high degree of assurance’’ is defined as degree of assurance that the specified plastics with certain additives comply 7. Out of Scope Comments ‘‘an evidence-based demonstration of consistent performance of a product with the phthalate content requirements We also received comments on issues regarding compliance based on of section 108 of the CPSIA, based on such as random spot checking for knowledge of a product and its evidence indicating that such materials certificates of compliance, developing a manufacture.’’ will not contain the prohibited procedure for petitioning the For a material determination, a ‘‘high phthalates. These determinations mean degree of assurance of compliance’’ that third party testing for compliance 12 Approaches for describing and communicating means that the material will comply with the phthalates prohibitions is not overall uncertainty in toxicity characterizations: with the specified chemical limits due required for certification purposes for U.S. Environmental Protection Agency’s Integrated the specified four plastics. The Risk Information System (IRIS) as a case study. The to the nature of the material or due to publication can be found at: https:// a processing technique that reduces the Commission makes these www.ncbi.nlm.nih.gov/pubmed/26827183. chemical concentration below its limit. 13 Staff notes that after the contract work 14 The Merriam-Webster online dictionary defines discussed here, TERA reorganized as the Risk For materials determined to comply a plasticizer as ‘‘a chemical added especially to Science Center at the University of Cincinnati: with a chemical limit, the material must rubbers and resins to impart flexibility, workability, https://med.uc.edu/eh/centers/rsc. continue to comply with that limit if it or stretchability.’’
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 41170 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations
determinations to reduce the third party preamble, currently, the agency is package, but were inadvertently left out testing burden on children’s product involved in rulemaking to determine of the codified text in the NPR; and certifiers while continuing to assure whether to continue the interim • Deletes ‘‘hydrocarbon solvents’’ compliance. prohibitions in section 108 and whether from the list of additives for PP in to prohibit any other children’s 2. Statutory Authority § 1308.2(a)(1)(ii) and ABS in products containing any other § 1308.2(a)(4)(ii) because hydrocarbon Section 3 of the CPSIA grants the phthalates. At the time of publication of solvents are not additives but rather are Commission general rulemaking this final rule in the Federal Register, used in the production of resin. The list authority to issue regulations, as the Commission has not issued a final of additives in §§ 1308.2(a)(1)(ii) and necessary, to implement the CPSIA. rule in the phthalates rulemaking. Public Law 110–314, sec. 3, Aug. 14, Therefore, this determinations rule lists (a)(4)(ii) has been renumbered to reflect 2008. As noted previously, section 14 of the phthalates that are statutorily this change. the CPSA, as amended by the CPSIA, prohibited from being in children’s toys Section 1308.2(b) of the rule states requires third party testing for and child care articles under section 108 that accessible component parts of children’s products subject to a of the CPSIA. children’s toys and child care articles children’s product safety rule. 15 U.S.C. Section 1308.2(a) of the rule made with the specified plastics, and 2063(a)(2). Section 14(d)(3)(B) of the establishes the Commission’s specified additives listed in paragraph CPSA, as amended by Public Law 112– determinations that the following seven (a) of this section, are not required to be 28, gives the Commission the authority plastics do not exceed the phthalates third party tested pursuant to section to ‘‘prescribe new or revised third party content limits with a ‘‘high degree of 14(a)(2) of the CPSA and 16 CFR part testing regulations if it determines that assurance’’ as that phrase is defined in 1107. Section 1308.2(b) is included in such regulations will reduce third party 16 CFR part 1107. Section 1308.2(a) of the rule to make clear that when the testing costs consistent with assuring the rule is being finalized as proposed, listed plastics and accompanying compliance with the applicable except for the following changes. The additives are used in children’s toys and consumer product safety rules, bans, final rule: child care articles, manufacturers and standards, and regulations.’’ Id. • Adds ‘‘naphthenic oil’’ to the list of importers are not required to conduct 2063(d)(3)(B). These statutory PP plasticizers in § 1308.2(a)(1)(i). the third party testing required in provisions authorize the Commission to Naphthenic oil is a nonphthalate section 14(a)(2) of the CPSA and 16 CFR issue a rule determining that specified plasticizer listed with paraffinic and plastics and additives will not exceed mineral plasticizing oils in a Task 12 part 1107. This provision is unchanged the phthalates prohibitions of section report reference and should have been from the proposed rule. 108 of the CPSIA, and therefore, included in the proposed rule but was Section 1308.2(c) of the rule has been specified plastics do not require third inadvertently omitted; revised to add the phrase ‘‘that are party conformity assessment body • Adds the word ‘‘unrecovered’’ plasticized or may contain phthalates’’ testing to assure compliance with the before ‘‘catalysts’’ in §§ 1308.2(a)(1)(iii), between ‘‘in paragraph (a) of this phthalates limits in section 108 of the (a)(2)(iv), (a)(3)(i), (a)(4)(vii) of the final section’’ and ‘‘are required to be third CPSIA. rule to clarify that this additive refers to party tested.’’ The new language tracks The determinations will relieve the small amounts of catalyst that may the statutory language of section 108(c) specified plastics and accompanying remain in a plastic resin after of the CPSIA regarding component parts additives from the third party testing manufacture; of children’s toys or child care articles • requirement of section 14 of the CPSA Adds general purpose polystyrene that are plasticized or may contain to support the required certification. (GPPS), medium-impact polystyrene phthalates. If a manufacturer or However, the determinations would not (MIPS), and super high-impact importer (i.e., a certifier) of a children’s apply to any other plastic or additives polystyrene (SHIPS) to § 1308.2(a)(3), to toy or child care article has accessible beyond those listed in the rule. high-impact polystyrene (HIPS) that was component parts that have been listed in the proposed rule, to the list of 3. Description of the Final Rule plasticized, or are composed of a materials that can be determined not to material that may contain phthalates, The rule creates a new part 1308 for require third party testing in order to third party testing is required to assure ‘‘Prohibition of Children’s Toys and assure compliance with section 108 of compliance to section 108 of the CPSIA. Child Care Articles Containing the CPSIA. This change is made based This change has been made because the Specified Phthalates: Determinations on a commenter’s suggestion and language of § 1308.2(c) of the proposed Regarding Certain Plastics.’’ The rule supporting information from the Task rule could be interpreted as conflicting determines that the specified plastics 16 report. These three plastics, along with section 108(c) of the CPSIA. and accompanying additives do not with HIPS, can be considered members contain the statutorily prohibited of a family of polystyrene plastics E. Effective Date phthalates (DEHP, DBP, BBP, DINP, manufactured with the same raw DIDP, DnOP) in concentrations above materials and processes. The potential The Administrative Procedure Act 0.1 percent, and thus, are not required additives for GPPS, MIPS, and SHIPS (APA) generally requires that a to be third party tested to assure are the same as those for HIPS; substantive rule must be published not compliance with section 108 of the • Replaces the term ‘‘phosphate less than 30 days before its effective CPSIA. esters’’ in § 1308.2(a)(4)(i) with date. 5 U.S.C. 553(d)(1). The Section 1308.1 of the rule explains the ‘‘hydrocarbon processing oil, triphenyl Commission proposed a 30-day effective statutorily created requirements for phosphate, resorcinol bis(diphenyl date because the rule provides relief children’s toys and child care articles phosphate), and oligomeric phosphate’’ from existing testing requirements under section 108 of the CPSIA and the to more precisely identify the ABS under the CPSIA. No comments were third party testing requirements for plasticizers listed. The specific received regarding the effective date. children’s products. This section is phosphate esters added were listed and The effective date for the rule is 30 days unchanged from the proposed rule. As discussed in the preamble of the NPR from the date of publication of the rule discussed in section A.2 of the and the underlying staff briefing in in the Federal Register.
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations 41171
F. Regulatory Flexibility Act The impact of the determinations on Commission rules from any requirement The Regulatory Flexibility Act (RFA), small businesses would be to reduce the to prepare an environmental assessment 5 U.S.C. 601–612, requires agencies to burden of third party testing for or an environmental impact statement consider the impact of proposed and phthalate content and would be because they ‘‘have little or no potential final rules on small entities, including expected to be entirely beneficial. The for affecting the human environment.’’ small businesses. Section 604 of the cost of third party testing for phthalates 16 CFR 1021.5(c)(2). This rule falls RFA requires that agencies prepare a is between approximately $125 and within the categorical exclusion, so no final regulatory flexibility analysis $350 per test, depending on where the environmental assessment or testing is conducted and any discounts environmental impact statement is (FRFA) when promulgating final rules, 16 unless the head of the agency certifies that might be applicable. Because one required. The Commission’s regulations that the rule will not have a significant product might have several component state that safety standards for products impact on a substantial number of small parts that require testing, the cost to test normally have little or no potential for a finished product for phthalate content entities. The FRFA must describe the affecting the human environment. 16 may be substantially higher. To the impact of the rule on small entities. CFR 1021.5(c)(1). Nothing in this rule extent that small entities have lower CPSC staff prepared a FRFA. See Tab C alters that expectation. of staff’s briefing package at https:// production volumes than larger entities, www.cpsc.gov/s3fs-public/Plastics- these determinations would be expected List of Subjects in 16 CFR Part 1308 Determinations-Final-Rule-August-16- to have a disproportionately beneficial Business and industry, Consumer 2017.pdf?wF38T29pcl.Z5lMna6tu4Y impact on small entities because the protection, Imports, Infants and o2HxWEZwb5. We provide a summary costs of the tests are distributed over children, Product testing and below. fewer units. Additionally, some The rule is intended to reduce the laboratories may offer their larger certification, Toys. customers discounts that might not be burden of third party testing on Accordingly, the Commission amends available to small entities that need manufacturers of children’s toys and title 16 of the Code of Federal fewer third party tests. However, the child care articles consistent with Regulations by adding part 1308 to read benefit of making the determinations assuring compliance with CPSC as follows: requirements under section 14 of the could be less than might be expected. CPSA, as amended by section 2 of For example, some manufacturers might PART 1308—PROHIBITION OF Public Law 112–28. The final rule have already substantially reduced their CHILDREN’S TOYS AND CHILD CARE third party phthalate testing costs by would reduce the burden of third party ARTICLES CONTAINING SPECIFIED using the component part testing under testing on manufacturers and importers PHTHALATES: DETERMINATIONS 16 CFR part 1109. Therefore, the of children’s toys and child care articles REGARDING CERTAIN PLASTICS by establishing determinations for marginal benefit that might be derived certain plastics (PP, PE, GPPS, MIPS, from making the determinations might Sec. HIPS, SHIPS, and ABS) and be low. Some importers might not be 1308.1 Prohibited children’s toys and child accompanying additives. Based on these certain of what materials are actually care articles containing specified determinations, the specified plastics being used in each component part and phthalates and testing requirements. with specified additives will not require might not be able to use the 1308.2 Determinations for specified third party testing for compliance with determinations without testing. plastics. the mandatory prohibitions on Under section 604 of the Regulatory Flexibility Act, a FRFA should include Authority: Sec. 3, Pub. L. 110–314, 122 children’s toys and child care articles Stat. 3016; 15 U.S.C. 2063(d)(3)(B). containing phthalates. a ‘‘statement of the factual, policy, and Although comprehensive estimates of legal reasons for selecting the alternative § 1308.1 Prohibited children’s toys and the number of products that contain adopted in the final rule and why each child care articles containing specified components made from the specified one of the other significant alternatives phthalates and testing requirements. plastics are not available, there is some to the rule considered by the agency which affect the impact on small Section 108(a) of the Consumer evidence that these plastics are Product Safety Improvement Act of extensively used in children’s toys. One entities was rejected.’’ The final rule is itself, the result of CPSC’s efforts to 2008 (CPSIA) permanently prohibits any source stated that polypropylene and children’s toy or child care article that high-density polyethylene are used in reduce third party testing costs consistent with assuring compliance contains concentrations of more than 38 and 25 percent, respectively, of 0.1 percent of di-(2-ethylhexl) phthalate injection-molded toys.15 The same with all applicable consumer product safety rules. Therefore, CPSC considered (DEHP), dibutyl phthalate (DBP), or source also stated that low-density benzyl butyl phthalate (BBP). Section polyethylene, polystyrene, and few alternatives, other than expanding the list of plastics for which 108(b)(1) of the CPSIA prohibits on an acrylonitrile butadiene styrene, are each interim basis any children’s toy that can used in less than 10 percent of injection- determinations could be made. We note be placed in a child’s mouth or child molded toys. that the final rule includes care article that contains concentrations Based on the number of domestic toy determinations for three additional of more than 0.1 percent of diisononyl manufacturers that are classified as polystyrenes (GPPS, MIPS, and SHIPS) small businesses by the U.S. Bureau of that were not included in the NPR. phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). the Census, and evidence that the G. Environmental Considerations specified plastics are used extensively Materials used in children’s toys and The Commission’s regulations in toys, staff believes a substantial child care articles subject to section provide a categorical exclusion for number of small entities would be 108(a) and (b)(1) of the CPSIA must impacted positively by this regulation. comply with the third party testing 16 The cost estimates of third party phthalate requirements of section 14(a)(2) of the testing are based on information provided both by 15 Donald V. Rosato, Plastics End Use consumer product manufacturers and by testing Consumer Product Safety Act (CPSA), Applications, Springer, New York, (2011). laboratories. unless listed in § 1308.2.
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1 41172 Federal Register / Vol. 82, No. 167 / Wednesday, August 30, 2017 / Rules and Regulations
§ 1308.2 Determinations for specified resorcinol bis(diphenyl phosphate), 79 FR 37536, effective December 30, plastics. oligomeric phosphate, long chain fatty 2014. That final rule, consistent with (a) The following plastics do not acid esters and aromatic sulfonamide; the two prior proposed rules for USML exceed the phthalates content limits (ii) Stabilizers; Category XI (78 FR 45018, July 25, 2013 with a high degree of assurance as that (iii) Lubricants; and 77 FR 70958, November 28, 2012), term is defined in 16 CFR part 1107: (iv) Antioxidants; revised paragraph (b) of Category XI to (1) Polypropylene (PP), with any of (v) Molecular weight regulators; clarify the extent of control and the following additives: (vi) Initiators/unrecovered catalysts, maintain the existing scope of control (i) The plasticizers polybutenes, (vii) Activators; on items described in paragraph (b) and dioctyl sebacate, isooctyl tallate, (viii) Emulsifiers; or the directly related software described paraffinic, naphthenic, and mineral (ix) Colorants. in paragraph (d). The Department has plasticizing oils, and polyol; (b) Accessible component parts of determined that exporters may read the (ii) Unrecovered catalysts; children’s toys and child care articles revised control language to exclude (iii) Fillers; made with the specified plastics, and certain intelligence-analytics software (iv) Primary and secondary specified additives, listed in paragraph that has been and remains controlled on antioxidants; (a) of this section are not required to be the USML. Therefore, the Department (v) Neutralizing agents; third party tested pursuant to section determined that it is in the interest of (vi) Antistatic agents; 14(a)(2) of the CPSA and 16 CFR part the security of the United States to (vii) Slip agents; 1107. temporarily revise USML Category XI (viii) Metal deactivators; (c) Accessible component parts of paragraph (b), pursuant to the (ix) Quenchers; children’s toys and child care articles provisions of 22 CFR 126.2, while a (x) UV stabilizers; made with a plastic or additives not long-term solution is developed. The (xi) Nucleating agents; listed in paragraph (a) of this section Department will publish any permanent (xii) Flame retardants; that are plasticized or may contain (xiii) Blowing or foaming agents; revision to USML Category XI paragraph phthalates are required to be third party (b) addressing this issue as a proposed (xiv) Antiblocking agents; tested pursuant to section 14(a)(2) of the (xv) Lubricants; or rule for public comment. CPSA and 16 CFR part 1107. (xvi) Colorants. This temporary revision clarifies that (2) Polyethylene (PE), with any of the Dated: August 25, 2017. the scope of control in existence prior following additives: Todd A. Stevenson, to December 30, 2014 for USML (i) The plasticizers glyceryl Secretary, Consumer Product Safety paragraph (b) and directly related tribenzoate, polyethylene glycol, Commission. software in paragraph (d) remains in sunflower oil, paraffin wax, paraffin oil, [FR Doc. 2017–18387 Filed 8–29–17; 8:45 am] effect. This clarification is achieved by reinserting the words ‘‘analyze and mineral oil, glycerin, EPDM rubber, and BILLING CODE 6355–01–P EVA polymer; produce information from’’ and by (ii) Initiators; adding software to the description of items controlled. (iii) Promoters; DEPARTMENT OF STATE (iv) Unrecovered catalysts; The Department previously published (v) Fillers; 22 CFR Part 121 a final rule on July 2, 2015 (80 FR (vi) Antistatic agents; 37974) that temporarily modified USML (vii) Flame retardants; [Public Notice 10082] Category XI(b) until December 29, 2015. (viii) Anti-blocking agents; RIN 1400–AE43 The Department published a final rule (ix) Slip agents; on December 16, 2015 (80 FR 78130) (x) Blowing agents; Temporary Modification of Category XI that continued the July 2, 2015 (xi) Cross-linking agents; of the United States Munitions List modification to August 30, 2017. This (xii) Antioxidants; final rule extends the July 2, 2015 (xiii) Carbon black; or AGENCY: Department of State. modification to August 30, 2018 to (xiv) Colorants. ACTION: Final rule; notice of temporary allow the U.S. government to review (3) General purpose polystyrene modification. USML Category XI in full and publish (GPPS), medium-impact polystyrene proposed and final rules. (MIPS), high-impact polystyrene (HIPS), SUMMARY: The Department of State, and super high-impact polystyrene pursuant to its regulations and in the Regulatory Findings (SHIPS) with any of the following interest of the security of the United Administrative Procedure Act additives: States, temporarily modifies Category XI (i) Unrecovered catalysts; of the United States Munitions List The Department is publishing this (ii) Internal lubricants; (USML). rule as a final rule based upon good (iii) Chain transfer/transition agents; cause, and its determination that DATES: Amendatory instructions 1 and 2 delaying the effect of this rule during a (iv) Stabilizers; are effective August 30, 2017. (v) Diluents; period of public comment would be Amendatory instruction No. 3 is impractical, unnecessary and contrary (vi) Colorants; effective August 30, 2018. (vii) Aluminum chloride, ethyl to public interest. 5 U.S.C. 553(b)(3)(B). chloride, hydrochloric acid; FOR FURTHER INFORMATION CONTACT: Mr. In addition, the Department is of the (viii) Iron oxide, potassium oxide, Robert Monjay, Office of Defense Trade opinion that controlling the import and chromium oxide; or Controls Policy, Department of State, export of defense articles and services is (ix) Bifunctional peroxides. telephone (202) 663–2817; email a foreign affairs function of the United (4) Acrylonitrile butadiene styrene [email protected]. ATTN: Temporary States Government and that rules (ABS), with any of the following Modification of Category XI. implementing this function are exempt additives: SUPPLEMENTARY INFORMATION: On July 1, from sections 553 (rulemaking) and 554 (i) The plasticizers hydrocarbon 2014, the Department published a final (adjudications) of the Administrative processing oil, triphenyl phosphate, rule revising Category XI of the USML, Procedure Act (APA).
VerDate Sep<11>2014 13:47 Aug 29, 2017 Jkt 241001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\30AUR1.SGM 30AUR1