CPSC Acceptance of Third Party Laboratories: Revision to the Notice of Requirements for Prohibitions of Children's Toys and Child Care Articles Containing Specified Phthalates, 49767-49770 [2017-23266]

Download as PDF Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules must comply with the requirements applicable to a $50 billion or over covered institution beginning on January 1 of the third calendar year after the national bank or Federal savings association becomes a $50 billion or over covered institution, unless that time is extended by the OCC in writing. A national bank or Federal savings association that becomes a $50 billion or over covered institution on or before September 30 of a calendar year must comply with the requirements applicable to a $50 billion or over covered institution beginning on January 1 of the second calendar year after the national bank or Federal savings association becomes a $50 billion or over covered institution, unless that time is extended by the OCC in writing. * * * * * ■ 5. Revise § 46.5 to read as follows: asabaliauskas on DSKBBXCHB2PROD with PROPOSALS § 46.5 Annual stress test. Each covered institution must conduct the annual stress test under this part subject to the following requirements: (a) Financial data. A covered institution must use financial data as of December 31 of the previous calendar year. (b) Scenarios provided by the OCC. In conducting the stress test under this part, each covered institution must use the scenarios provided by the OCC. The scenarios provided by the OCC will reflect a minimum of three sets of economic and financial conditions, including baseline, adverse, and severely adverse scenarios. The OCC will provide a description of the scenarios required to be used by each covered institution no later than February 15 of that calendar year. (c) Significant trading activities. The OCC may require a covered institution with significant trading activities, as determined by the OCC, to include trading and counterparty components in its adverse and severely adverse scenarios. The trading and counterparty position data to be used in this component will be as of a date between October 1 of the previous calendar year and March 1 of that calendar year in which the stress test is performed, and the OCC will communicate a description of the component to the covered institution no later than March 1 of that calendar year. (d) Use of stress test results. The board of directors and senior management of each covered institution must consider the results of the stress tests conducted under this section in the normal course of business, including but not limited to the covered institution’s capital VerDate Sep<11>2014 16:36 Oct 26, 2017 Jkt 244001 planning, assessment of capital adequacy, and risk management practices. ■ 6. Section 46.7 is amended by revising paragraphs (a) and (b) to read as follows: § 46.7 Reports to the Office of the Comptroller of the Currency and the Board of Governors of the Federal Reserve System. (a) $10 to $50 billion covered institution. A $10 to $50 billion covered institution must report to the OCC and to the Board of Governors of the Federal Reserve System, on or before July 31, the results of the stress test in the manner and form specified by the OCC. (b) $50 billion or over covered institution. A $50 billion or over covered institution must report to the OCC and to the Board of Governors of the Federal Reserve System, on or before April 5, the results of the stress test in the manner and form specified by the OCC. * * * * * ■ 7. Section 46.8 is amended by revising paragraph (a) to read as follows: § 46.8 Publication of disclosures. (a) Publication date. (1) $50 billion or over covered institution. A $50 billion or over covered institution must publish a summary of the results of its annual stress test in the period starting June 15 and ending July 15 provided: (i) Unless the OCC determines otherwise, if the $50 billion or over covered institution is a consolidated subsidiary of a bank holding company or savings and loan holding company subject to supervisory stress tests conducted by the Board of Governors of the Federal Reserve System pursuant to 12 CFR part 252, then within the June 15 to July 15 period such covered institution may not publish the required summary of its annual stress test earlier than the date that the Board of Governors of the Federal Reserve System publishes the supervisory stress test results of the covered bank’s parent holding company. (ii) If the Board of Governors of the Federal Reserve System publishes the supervisory stress test results of the covered institution’s parent holding company prior to June 15, then such covered institution may publish its stress test results prior to June 15, but no later than July 15, through actual publication by the covered institution or through publication by the parent holding company pursuant to paragraph (b) of this section. (2) $10 to $50 billion covered institution. A $10 to $50 billion covered institution must publish a summary of the results of its annual stress test in the PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 49767 period starting October 15 and ending October 31. * * * * * Dated: October 19, 2017. Keith A. Noreika, Acting Comptroller of the Currency. [FR Doc. 2017–23353 Filed 10–26–17; 8:45 am] BILLING CODE 4810–33–P CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC–2017–0043] 16 CFR Part 1112 CPSC Acceptance of Third Party Laboratories: Revision to the Notice of Requirements for Prohibitions of Children’s Toys and Child Care Articles Containing Specified Phthalates Consumer Product Safety Commission. ACTION: Notice of proposed rulemaking. AGENCY: This notice of proposed rulemaking (NPR) would update the existing notice of requirements (NOR) for prohibitions of children’s toys and child care articles containing specified phthalates that provide the criteria and process for Commission acceptance of accreditation pursuant to the Consumer Product Safety Act (CPSA). The proposed NOR would revise the current NOR to be consistent with the final phthalates rule, which is published elsewhere in this same issue of the Federal Register and will be codified in the Code of Federal Regulations (CFR). DATES: Submit comments by January 10, 2018. ADDRESSES: You may submit comments, identified by Docket No. CPSC–2017– 0043, by any of the following methods: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https:// www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Written Submissions: Submit written submissions by mail/hand delivery/ courier to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504–7923. Instructions: All submissions received must include the agency name and SUMMARY: E:\FR\FM\27OCP1.SGM 27OCP1 49768 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules asabaliauskas on DSKBBXCHB2PROD with PROPOSALS docket number for this notice. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov, and insert the docket number CPSC–2017–0043, into the ‘‘Search’’ box, and follow the prompts. FOR FURTHER INFORMATION CONTACT: Scott R. Heh, Project Manager, Directorate for Laboratory Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301–504–7646; email: sheh@ cpsc.gov. SUPPLEMENTARY INFORMATION: A. Background Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established requirements concerning concentration limits for specified phthalates in children’s toys and child care articles. In this same issue of the Federal Register, the Commission is publishing a final rule that changes some of the statutory phthalate restrictions currently in place pursuant to section 108(b)(3) of the CPSIA. 15 U.S.C. 2063c(a). The Commission’s phthalates rule makes permanent the interim prohibition on children’s toys that can be placed in a child’s mouth and child care articles that contain concentrations of more than 0.1 percent of diisononyl phthalate (DINP). The phthalates rule extends this prohibition to cover all children’s toys and child care articles containing concentrations of more than 0.1 percent of DINP. The phthalates rule also lifts the interim prohibitions on children’s toys that can be placed in a child’s mouth and child care articles that contain concentrations of more than 0.1 percent of di-n-octyl phthalate (DNOP) or diisodecyl phthalate (DIDP). In addition, the phthalates rule prohibits children’s toys and child care articles that contain concentrations of more than 0.1 percent of diisobutyl phthalate (DIBP), Di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP). The permanent prohibitions on children’s toys and child care articles that contain VerDate Sep<11>2014 16:36 Oct 26, 2017 Jkt 244001 concentrations of more than 0.1 percent on the use of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP) in children’s toys and child care articles in section 108 of the CPSIA are unchanged by the phthalate rule. Because the phthalates rule revises the list of statutorily prohibited phthalates in children’s toys and child care articles in section 108 of the CPSIA, this NPR proposes to amend the existing NOR for the prohibitions of children’s toys and child care articles containing specified phthalates to reflect those changes. B. Notice of Requirements Section 14(a) of the CPSA requires that products subject to a consumer product safety rule under the CPSA, or to a similar rule, ban, standard, or regulation under any other act enforced by the Commission, be certified as complying with all applicable CPSC requirements. 15 U.S.C. 2063(a). Such certification must be based on a test of each product, or on a reasonable testing program or, for children’s products, on tests of a sufficient number of samples by a third party conformity assessment body accredited by the Commission to test according to the applicable requirements. The Commission’s phthalates rule is considered a ‘‘consumer product safety standard.’’ 15 U.S.C. 2063c(f). Thus, products subject to the phthalates rule are subject to the testing and certification requirements of section 14 of the CPSA. Because children’s toys and child care articles are children’s products, samples of these products must be tested by a third party conformity assessment body whose accreditation has been accepted by the Commission. These products also must comply with all other applicable CPSC requirements, such as the lead content requirements of section 101 of the CPSIA, the requirements of the toy standard, 16 CFR part 1250, and the tracking label requirement in section 14(a)(5) of the CPSA. In accordance with section 14(a)(3)(B)(vi) of the CPSIA, the Commission has previously published two NORs for accreditation of third party conformity assessment bodies for testing children’s toys and child care articles under section 108 of the CPSIA (76 FR 49286 (Aug. 10, 2011), 78 FR 15836 (March 12, 2013)). If the Commission finalizes the NOR as proposed, the following process would be used during the transition period from test method CPSC–CH– C1001–09.3 (2010) to a revised version of the method, currently titled, draft test method CPSC–CH–C1001–09.4 (2017). PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 CPSC would accept testing to support children’s toys and child care article certifications to the new phthalates prohibitions if the laboratory is already CPSC-accepted to test to CPSC–CH– C1001–09.3 (2010). Laboratories that conduct testing to support product certifications to the new phthalates prohibitions must list in their test reports ‘‘16 CFR part 1307’’ and CPSC– CH–C1001–09.3 until laboratories have transitioned their accreditation scope and CPSC listing to CPSC–CH–C1001– 09.4. The CPSC would open the laboratory application process for draft test method CPSC–CH–C1001–09.4 (2017) on the date the final NOR rule is published in the Federal Register. Laboratories that seek CPSC acceptance to the revised prohibitions for children’s toys and child care articles in 16 CFR part 1307 would be required to update their accreditation scope. To be CPSCaccepted, a laboratory’s scope of accreditation must include the reference to draft CPSC–CH–C1001–09.4 (2017). Laboratories that are currently CPSCaccepted to CPSC–CH–C1001–09.3 (2010) would be instructed to update their accreditation scope to include draft CPSC–CH–C1001–09.4 (2017) as soon as possible, and submit their application for CPSC acceptance. Laboratories that were not previously CPSC-accepted to CPSC–CH–C1001– 09.3 (2010) would be instructed to work with their accreditation bodies to include ‘‘CPSC–CH–C1001–09.4 (2017)’’ in their scope documents. CPSC would accept testing results to the new phthalates prohibitions in 16 CFR part 1307 from laboratories that are CPSC-accepted to CPSC–CH–C1001– 09.3 (2010) for two years from the date of publication of the final rule NOR in the Federal Register. This should allow adequate time for laboratories to work with their accreditation bodies to make official updates to their accreditation scope document to include the revised CPSC method ‘‘CPSC–CH–C1001–09.4 (2017)’’ and submit applications to the CPSC. Two years after the date the final rule NOR publishes in the Federal Register, the CPSC will no longer accept laboratory applications that reference CPSC–CH–C1001–09.3 (2010), and any application to CPSC must reference ‘‘CPSC–CH–C1001–09.4 (2017).’’ C. Description of the Proposed Rule The proposed rule would amend 16 CFR 1112(b)(31), (31)(i) and (c)(3)(i) to update the references to reflect the promulgation of 16 CFR part 1307 and draft CPSC test method CPSC–CH– C1001–09.4 (2017). The draft test method would provide detailed E:\FR\FM\27OCP1.SGM 27OCP1 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules asabaliauskas on DSKBBXCHB2PROD with PROPOSALS information on testing that will be used by the CPSC testing laboratory for the analysis of phthalate content in children’s toys and child care articles. CPSC staff has determined that using an appropriate combination of the methods of extraction and analysis presented in the test method is sufficient to determine the concentration of the regulated phthalates in most children’s toys and child care articles. The general approach is to dissolve the sample completely in tetrahydrofuran, precipitate any PVC polymer with a second solvent, then analyze by Gas Chromatography-Mass Spectrometry (GC–MS). The draft test method provides definitions, a list of equipment and supplies needed for testing, procedures to measure phthalate concentration, instructions for sample preparation, and descriptions of the phthalate extraction method and instrument parameters. The draft test method is available at Tab A of the CPSC staff’s briefing package available on CPSC’s Web site at: https:// www.cpsc.gov/s3fs-public/ Notice%20of% 20Proposed%20Rulemaking%20for %20NOR%20for%20Phthalates%20-% 20September%2013%202017.pdf?pH5_ n4seuAb0.USRYqPfsnmLuTKC8F_2. Draft CPSC test method CPSC–CH– C1001–09.4 (2017) has been updated to reflect the list of phthalates prohibited in children’s toys and child care articles in 16 CFR part 1307 ((di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), din-octyl phthalate (DNOP) diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate (DCHP)). The draft test method CPSC–CH–C1001–09.4 (2017) is substantially the same as the current testing procedure. The Commission encourages comments on draft CPSC test method CPSC–CH– C1001–09.4 (2017). We note that the draft test method could change in the final rule. D. Effective Date The APA generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the proposed rule would allow testing to continue under the existing testing method by testing laboratories that meet certain criteria for a period of up to two years after the publication of a final rule, the Commission proposes a 30 day effective date for the final rule. E. Regulatory Flexibility Act The Regulatory Flexibility Act (RFA) requires an agency to prepare a VerDate Sep<11>2014 16:36 Oct 26, 2017 Jkt 244001 regulatory flexibility analysis for any rule subject to notice and comment rulemaking requirements under the APA, or any other statute, unless the agency certifies that the rulemaking will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 603 and 605. Small entities include small businesses, small organizations, and small governmental jurisdictions. The impact of the proposed rule on small testing laboratories would be minimal. The only laboratories that would be impacted are those that offer to test children’s toys and child care articles for prohibited phthalates. These laboratories are already accredited by one or more accreditation bodies that are signatories to the International Laboratory Accreditation Cooperation— Mutual Recognition Arrangement (ILAC–MRA) and have had their accreditations accepted by the Commission. These laboratories would have to revise their procedures for testing for phthalate content to be consistent with the revised phthalate test method (CPSC–CH–C1001–09.4) which would replace the current phthalate test method (CPSC–CH– C1001–09.3) if the proposed NOR is finalized. Staff expects that the impact of revising testing procedures will be low for qualified laboratories because the same sample preparation, extraction methods, and equipment is used for both methods. Moreover, the additional phthalates included in draft CPSC–CH– C1001–09.4 can be isolated at unique elution times by gas chromatography and, therefore, the analysis should not be a burden for those qualified to perform such testing. Additionally, within two years of the publication of the final NOR rule, laboratories would need to update their scope accreditation documents to include the revised phthalate test method (CPSC–CH–C1001–09.4). Staff expects that the burden of this requirement will also be low because testing laboratories typically must undergo a reassessment every two years in order to maintain their accreditations. Updating the accreditation scope documents to include the revised phthalate test method is a minor change and should result in little or no additional cost to a testing laboratory if completed during the periodic reassessment, which the 2-year window would allow testing laboratories to do. After considering the economic impacts of this proposed rule on small entities, the Commission certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 49769 F. Environmental Considerations The Commission’s regulations provide a categorical exclusion for the Commission’s rules from any requirement to prepare an environmental assessment or an environmental impact statement 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. List of Subjects in 16 CFR Part 1112 Administrative practice and procedure, Audit, Consumer protection, Incorporation by reference, Reporting and recordkeeping requirements, Third party conformity assessment body. For the reasons discussed in the preamble, the Commission proposes to amend Title 16 CFR chapter II, as follows: PART 1112—REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY ASSESSMENT BODIES 1. The authority citation for part 1112 continues to read as follows: ■ Authority: 15 U.S.C. 2063; Pub. L. 110– 314, section 3, 122 Stat. 3016, 3017 (2008). 2. Amend § 1112.15 by: ■ a. Revising the introductory text to paragraph (b)(31); ■ b. Revising paragraph (b)(31)(i); and ■ c. Revising paragraph (c)(3)(i). The revisions read as follows: ■ § 1112.15 When can a third party conformity assessment body apply for CPSC acceptance for a particular CPSC rule or test method? * * * * * (b) * * * (31) 16 CFR part 1307, Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. For its accreditation to be accepted by the Commission to test for phthalates in children’s toys and child care articles, a third party conformity assessment body must have one or more of the following test methods referenced in its statement of scope: (i) CPSC Test Method CPSC–CH– 1001–09.4, ‘‘Standard Operating Procedure for Determination of Phthalates; * * * * * (c) * * * (3) * * * E:\FR\FM\27OCP1.SGM 27OCP1 49770 Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Proposed Rules (i) CPSC–CH–C1001–9.4, ‘‘Standard Operating Procedure for Determination of Phthalates’’, September 1, 2017. * * * * * Alberta E. Mills, Acting Secretary, U.S. Consumer Product Safety Commission. [FR Doc. 2017–23266 Filed 10–26–17; 8:45 am] BILLING CODE 6355–01–P DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Part 395 [Docket No. FMCSA–2017–0296] Hours of Service of Drivers: Application for Exemption; Western Equipment Dealers Association (WEDA) Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Application for exemption; request for comments. AGENCY: FMCSA announces that the Western Equipment Dealers Association (WEDA) has requested an exemption on behalf of several other organizations and their membership from the requirement that no later than December 18, 2017, a motor carrier require each of its drivers to use an electronic logging device (ELD) to record the driver’s hours-ofservice (HOS). WEDA states that equipment dealer operations in agriculture constitute unique circumstances that warrant the requested exemption, and not granting it will pose an undue burden on equipment dealers and their customers without any measurable safety benefit. In its application, WEDA seeks a fiveyear, renewable exemption from the ELD requirements which, the organization states, if granted will achieve a level of safety equivalent to, or greater than, the level that would be achieved absent the proposed exemption. FMCSA requests public comment on WEDA’s application for exemption. SUMMARY: Comments must be received on or before November 27, 2017. ADDRESSES: You may submit comments identified by Federal Docket Management System (FDMS) Number FMCSA–2017–0296 by any of the following methods: • Federal eRulemaking Portal: www.regulations.gov. See the Public Participation and Request for Comments section below for further information. asabaliauskas on DSKBBXCHB2PROD with PROPOSALS DATES: VerDate Sep<11>2014 16:36 Oct 26, 2017 Jkt 244001 • Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building, Ground Floor, Room W12–140, Washington, DC 20590–0001. • Hand Delivery or Courier: West Building, Ground Floor, Room W12– 140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • Fax: 1–202–493–2251. • Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to www.regulations.gov, including any personal information included in a comment. Please see the Privacy Act heading below. Docket: For access to the docket to read background documents or comments, go to www.regulations.gov at any time or visit Room W12–140 on the ground level of the West Building, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. The on-line FDMS is available 24 hours each day, 365 days each year. Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to www.regulations.gov, as described in the system of records notice (DOT/ALL–14 FDMS), which can be reviewed at www.dot.gov/privacy. FOR FURTHER INFORMATION CONTACT: For information concerning this notice, contact Mr. Tom Yager, Chief, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 614–942– 6477. Email: MCPSD@dot.gov. If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366–9826. SUPPLEMENTARY INFORMATION: I. Public Participation and Request for Comments FMCSA encourages you to participate by submitting comments and related materials. Submitting Comments If you submit a comment, please include the docket number for this notice (FMCSA–2017–0296), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission. To submit your comments online, go to www.regulations.gov and put the docket number, ‘‘FMCSA–2017–0296’’ in the ‘‘Keyword’’ box, and click ‘‘Search.’’ When the new screen appears, click on ‘‘Comment Now!’’ button and type your comment into the text box in the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81⁄2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope. FMCSA will consider all comments and material received during the comment period and may grant or not grant this application based on your comments. II. Legal Basis FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the Federal Register (49 CFR 381.315(a)). The Agency must provide the public an opportunity to inspect the information relevant to the application, including any safety analyses that have been conducted. The Agency must also provide an opportunity for public comment on the request. The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the Federal Register (49 CFR 381.315(b)) with the reasons for denying or granting the application and, if granted, the name of the person or class of persons receiving the exemption, and the regulatory provision from which the exemption is granted. The notice must also specify the effective period and explain the terms and conditions of the exemption. The exemption may be renewed (49 CFR 381.300(b)). E:\FR\FM\27OCP1.SGM 27OCP1

Agencies

[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Proposed Rules]
[Pages 49767-49770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23266]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2017-0043]

16 CFR Part 1112


CPSC Acceptance of Third Party Laboratories: Revision to the 
Notice of Requirements for Prohibitions of Children's Toys and Child 
Care Articles Containing Specified Phthalates

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This notice of proposed rulemaking (NPR) would update the 
existing notice of requirements (NOR) for prohibitions of children's 
toys and child care articles containing specified phthalates that 
provide the criteria and process for Commission acceptance of 
accreditation pursuant to the Consumer Product Safety Act (CPSA). The 
proposed NOR would revise the current NOR to be consistent with the 
final phthalates rule, which is published elsewhere in this same issue 
of the Federal Register and will be codified in the Code of Federal 
Regulations (CFR).

DATES: Submit comments by January 10, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2017-
0043, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The Commission does not accept 
comments submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Office of the Secretary, Consumer Product Safety 
Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; 
telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and

[[Page 49768]]

docket number for this notice. All comments received may be posted 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number CPSC-2017-0043, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Scott R. Heh, Project Manager, 
Directorate for Laboratory Sciences, Consumer Product Safety 
Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-504-
7646; email: [email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    Section 108 of the Consumer Product Safety Improvement Act of 2008 
(CPSIA) established requirements concerning concentration limits for 
specified phthalates in children's toys and child care articles. In 
this same issue of the Federal Register, the Commission is publishing a 
final rule that changes some of the statutory phthalate restrictions 
currently in place pursuant to section 108(b)(3) of the CPSIA. 15 
U.S.C. 2063c(a). The Commission's phthalates rule makes permanent the 
interim prohibition on children's toys that can be placed in a child's 
mouth and child care articles that contain concentrations of more than 
0.1 percent of diisononyl phthalate (DINP). The phthalates rule extends 
this prohibition to cover all children's toys and child care articles 
containing concentrations of more than 0.1 percent of DINP. The 
phthalates rule also lifts the interim prohibitions on children's toys 
that can be placed in a child's mouth and child care articles that 
contain concentrations of more than 0.1 percent of di-n-octyl phthalate 
(DNOP) or diisodecyl phthalate (DIDP). In addition, the phthalates rule 
prohibits children's toys and child care articles that contain 
concentrations of more than 0.1 percent of diisobutyl phthalate (DIBP), 
Di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and 
dicyclohexyl phthalate (DCHP). The permanent prohibitions on children's 
toys and child care articles that contain concentrations of more than 
0.1 percent on the use of di-(2-ethylhexyl) phthalate (DEHP), dibutyl 
phthalate (DBP), and benzyl butyl phthalate (BBP) in children's toys 
and child care articles in section 108 of the CPSIA are unchanged by 
the phthalate rule.
    Because the phthalates rule revises the list of statutorily 
prohibited phthalates in children's toys and child care articles in 
section 108 of the CPSIA, this NPR proposes to amend the existing NOR 
for the prohibitions of children's toys and child care articles 
containing specified phthalates to reflect those changes.

B. Notice of Requirements

    Section 14(a) of the CPSA requires that products subject to a 
consumer product safety rule under the CPSA, or to a similar rule, ban, 
standard, or regulation under any other act enforced by the Commission, 
be certified as complying with all applicable CPSC requirements. 15 
U.S.C. 2063(a). Such certification must be based on a test of each 
product, or on a reasonable testing program or, for children's 
products, on tests of a sufficient number of samples by a third party 
conformity assessment body accredited by the Commission to test 
according to the applicable requirements. The Commission's phthalates 
rule is considered a ``consumer product safety standard.'' 15 U.S.C. 
2063c(f). Thus, products subject to the phthalates rule are subject to 
the testing and certification requirements of section 14 of the CPSA.
    Because children's toys and child care articles are children's 
products, samples of these products must be tested by a third party 
conformity assessment body whose accreditation has been accepted by the 
Commission. These products also must comply with all other applicable 
CPSC requirements, such as the lead content requirements of section 101 
of the CPSIA, the requirements of the toy standard, 16 CFR part 1250, 
and the tracking label requirement in section 14(a)(5) of the CPSA.
    In accordance with section 14(a)(3)(B)(vi) of the CPSIA, the 
Commission has previously published two NORs for accreditation of third 
party conformity assessment bodies for testing children's toys and 
child care articles under section 108 of the CPSIA (76 FR 49286 (Aug. 
10, 2011), 78 FR 15836 (March 12, 2013)).
    If the Commission finalizes the NOR as proposed, the following 
process would be used during the transition period from test method 
CPSC-CH-C1001-09.3 (2010) to a revised version of the method, currently 
titled, draft test method CPSC-CH-C1001-09.4 (2017). CPSC would accept 
testing to support children's toys and child care article 
certifications to the new phthalates prohibitions if the laboratory is 
already CPSC-accepted to test to CPSC-CH-C1001-09.3 (2010). 
Laboratories that conduct testing to support product certifications to 
the new phthalates prohibitions must list in their test reports ``16 
CFR part 1307'' and CPSC-CH-C1001-09.3 until laboratories have 
transitioned their accreditation scope and CPSC listing to CPSC-CH-
C1001-09.4.
    The CPSC would open the laboratory application process for draft 
test method CPSC-CH-C1001-09.4 (2017) on the date the final NOR rule is 
published in the Federal Register. Laboratories that seek CPSC 
acceptance to the revised prohibitions for children's toys and child 
care articles in 16 CFR part 1307 would be required to update their 
accreditation scope. To be CPSC-accepted, a laboratory's scope of 
accreditation must include the reference to draft CPSC-CH-C1001-09.4 
(2017). Laboratories that are currently CPSC-accepted to CPSC-CH-C1001-
09.3 (2010) would be instructed to update their accreditation scope to 
include draft CPSC-CH-C1001-09.4 (2017) as soon as possible, and submit 
their application for CPSC acceptance. Laboratories that were not 
previously CPSC-accepted to CPSC-CH-C1001-09.3 (2010) would be 
instructed to work with their accreditation bodies to include ``CPSC-
CH-C1001-09.4 (2017)'' in their scope documents.
    CPSC would accept testing results to the new phthalates 
prohibitions in 16 CFR part 1307 from laboratories that are CPSC-
accepted to CPSC-CH-C1001-09.3 (2010) for two years from the date of 
publication of the final rule NOR in the Federal Register. This should 
allow adequate time for laboratories to work with their accreditation 
bodies to make official updates to their accreditation scope document 
to include the revised CPSC method ``CPSC-CH-C1001-09.4 (2017)'' and 
submit applications to the CPSC. Two years after the date the final 
rule NOR publishes in the Federal Register, the CPSC will no longer 
accept laboratory applications that reference CPSC-CH-C1001-09.3 
(2010), and any application to CPSC must reference ``CPSC-CH-C1001-09.4 
(2017).''

C. Description of the Proposed Rule

    The proposed rule would amend 16 CFR 1112(b)(31), (31)(i) and 
(c)(3)(i) to update the references to reflect the promulgation of 16 
CFR part 1307 and draft CPSC test method CPSC-CH-C1001-09.4 (2017). The 
draft test method would provide detailed

[[Page 49769]]

information on testing that will be used by the CPSC testing laboratory 
for the analysis of phthalate content in children's toys and child care 
articles. CPSC staff has determined that using an appropriate 
combination of the methods of extraction and analysis presented in the 
test method is sufficient to determine the concentration of the 
regulated phthalates in most children's toys and child care articles. 
The general approach is to dissolve the sample completely in 
tetrahydrofuran, precipitate any PVC polymer with a second solvent, 
then analyze by Gas Chromatography-Mass Spectrometry (GC-MS). The draft 
test method provides definitions, a list of equipment and supplies 
needed for testing, procedures to measure phthalate concentration, 
instructions for sample preparation, and descriptions of the phthalate 
extraction method and instrument parameters. The draft test method is 
available at Tab A of the CPSC staff's briefing package available on 
CPSC's Web site at: https://www.cpsc.gov/s3fs-public/Notice%20of%20Proposed%20Rulemaking%20for%20NOR%20for%20Phthalates%20-%20September%2013%202017.pdf?pH5_n4seuAb0.USRYqPfsnmLuTKC8F_2. Draft 
CPSC test method CPSC-CH-C1001-09.4 (2017) has been updated to reflect 
the list of phthalates prohibited in children's toys and child care 
articles in 16 CFR part 1307 ((di(2-ethylhexyl) phthalate (DEHP), 
dibutyl phthalate (DBP), butyl benzyl phthalate (BBP), di-n-octyl 
phthalate (DNOP) diisobutyl phthalate (DIBP), di-n-pentyl phthalate 
(DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate 
(DCHP)). The draft test method CPSC-CH-C1001-09.4 (2017) is 
substantially the same as the current testing procedure. The Commission 
encourages comments on draft CPSC test method CPSC-CH-C1001-09.4 
(2017). We note that the draft test method could change in the final 
rule.

D. Effective Date

    The APA generally requires that a substantive rule must be 
published not less than 30 days before its effective date. 5 U.S.C. 
553(d)(1). Because the proposed rule would allow testing to continue 
under the existing testing method by testing laboratories that meet 
certain criteria for a period of up to two years after the publication 
of a final rule, the Commission proposes a 30 day effective date for 
the final rule.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to prepare 
a regulatory flexibility analysis for any rule subject to notice and 
comment rulemaking requirements under the APA, or any other statute, 
unless the agency certifies that the rulemaking will not have a 
significant economic impact on a substantial number of small entities. 
5 U.S.C. 603 and 605. Small entities include small businesses, small 
organizations, and small governmental jurisdictions.
    The impact of the proposed rule on small testing laboratories would 
be minimal. The only laboratories that would be impacted are those that 
offer to test children's toys and child care articles for prohibited 
phthalates. These laboratories are already accredited by one or more 
accreditation bodies that are signatories to the International 
Laboratory Accreditation Cooperation--Mutual Recognition Arrangement 
(ILAC-MRA) and have had their accreditations accepted by the 
Commission. These laboratories would have to revise their procedures 
for testing for phthalate content to be consistent with the revised 
phthalate test method (CPSC-CH-C1001-09.4) which would replace the 
current phthalate test method (CPSC-CH-C1001-09.3) if the proposed NOR 
is finalized. Staff expects that the impact of revising testing 
procedures will be low for qualified laboratories because the same 
sample preparation, extraction methods, and equipment is used for both 
methods. Moreover, the additional phthalates included in draft CPSC-CH-
C1001-09.4 can be isolated at unique elution times by gas 
chromatography and, therefore, the analysis should not be a burden for 
those qualified to perform such testing.
    Additionally, within two years of the publication of the final NOR 
rule, laboratories would need to update their scope accreditation 
documents to include the revised phthalate test method (CPSC-CH-C1001-
09.4). Staff expects that the burden of this requirement will also be 
low because testing laboratories typically must undergo a reassessment 
every two years in order to maintain their accreditations. Updating the 
accreditation scope documents to include the revised phthalate test 
method is a minor change and should result in little or no additional 
cost to a testing laboratory if completed during the periodic 
reassessment, which the 2-year window would allow testing laboratories 
to do.
    After considering the economic impacts of this proposed rule on 
small entities, the Commission certifies that the proposed rule would 
not have a significant economic impact on a substantial number of small 
entities.

F. Environmental Considerations

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

List of Subjects in 16 CFR Part 1112

    Administrative practice and procedure, Audit, Consumer protection, 
Incorporation by reference, Reporting and recordkeeping requirements, 
Third party conformity assessment body.

    For the reasons discussed in the preamble, the Commission proposes 
to amend Title 16 CFR chapter II, as follows:

PART 1112--REQUIREMENTS PERTAINING TO THIRD PARTY CONFORMITY 
ASSESSMENT BODIES

0
1. The authority citation for part 1112 continues to read as follows:

    Authority: 15 U.S.C. 2063; Pub. L. 110-314, section 3, 122 Stat. 
3016, 3017 (2008).

0
2. Amend Sec.  1112.15 by:
0
a. Revising the introductory text to paragraph (b)(31);
0
b. Revising paragraph (b)(31)(i); and
0
c. Revising paragraph (c)(3)(i).
    The revisions read as follows:


Sec.  1112.15  When can a third party conformity assessment body apply 
for CPSC acceptance for a particular CPSC rule or test method?

* * * * *
    (b) * * *
    (31) 16 CFR part 1307, Prohibition of Children's Toys and Child 
Care Articles Containing Specified Phthalates. For its accreditation to 
be accepted by the Commission to test for phthalates in children's toys 
and child care articles, a third party conformity assessment body must 
have one or more of the following test methods referenced in its 
statement of scope:
    (i) CPSC Test Method CPSC-CH-1001-09.4, ``Standard Operating 
Procedure for Determination of Phthalates;
* * * * *
    (c) * * *
    (3) * * *

[[Page 49770]]

    (i) CPSC-CH-C1001-9.4, ``Standard Operating Procedure for 
Determination of Phthalates'', September 1, 2017.
* * * * *

Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2017-23266 Filed 10-26-17; 8:45 am]
BILLING CODE 6355-01-P
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