Regulatory Flexibility Act Section 610 Review of the Testing and Labeling Regulations Pertaining to Product Certification of Children's Products, Including Reliance on Component Part Testing, 52078-52081 [2020-16441]

Download as PDF 52078 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Proposed Rules CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Parts 1107 and 1109 [Docket No. CPSC–2020–0019] Regulatory Flexibility Act Section 610 Review of the Testing and Labeling Regulations Pertaining to Product Certification of Children’s Products, Including Reliance on Component Part Testing Consumer Product Safety Commission. ACTION: Notification of section 610 review and request for comments. AGENCY: The Consumer Product Safety Commission (Commission or CPSC) is conducting a review of the regulations for third party testing and certification to demonstrate compliance with safety standards for children’s products, under section 610 of the Regulatory Flexibility Act (RFA). That section requires the CPSC to review within 10 years after their issuance regulations that have a significant economic impact on a substantial number of small entities. The testing and component part regulations were promulgated in 2011. The CPSC seeks comment to determine whether, consistent with the CPSC’s statutory obligations, these regulations should be maintained without change, or modified to minimize the significant impact of the rules on a substantial number of small entities. DATES: Written comments should be submitted by October 23, 2020. ADDRESSES: You may submit comments, identified by Docket No. CPSC–2020– 0019, 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 CPSC does not accept comments submitted by electronic mail (email), except through https:// www.regulations.gov. The CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Mail/hand delivery/courier Written Submissions: Submit comments by mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504–7479; email: cpsc-os@cpsc.gov. Instructions: All submissions must include the agency name and docket number for this notice. CPSC may post all comments received without change, jbell on DSKJLSW7X2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:10 Aug 21, 2020 Jkt 250001 including any personal identifiers, contact information, or other personal information provided, to: https:// www.regulations.gov. Do not submit electronically: confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for written submissions. 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–2020–0019, into the ‘‘Search’’ box, and follow the prompts. FOR FURTHER INFORMATION CONTACT: Susan Proper, Directorate for Economic Analysis, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504–7628; email: sproper@cpsc.gov. SUPPLEMENTARY INFORMATION: A. The Current Regulations in 16 CFR Parts 1107 and 1109 Section 14 of the Consumer Product Safety Act (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA) and Public Law 112–28 (2011), establishes requirements for the testing and certification of products subject to consumer product safety rules under the CPSA, or similar rules, bans, standards, or regulations, under any other Act enforced by the Commission. The domestic manufacturer or the importer of the product must issue a certificate that the product complies with applicable safety standards. Under section 14(a)(2) of the CPSA, the certification of children’s products must be based on testing conducted by an accredited third party conformity assessment body (a third party testing laboratory). Section 14(i)(2) of the CPSA directed the Commission to publish a regulation that would ‘‘initiate a program by which a manufacturer or private labeler may label a consumer product as complying with the certification requirements’’ and to establish protocols and standards for: • Ensuring that a children’s product is subject to testing periodically and when there has been a material change in the product’s design or manufacturing process, and • The testing of representative samples to ensure continued compliance, and • Verifying that a children’s product tested by a conformity assessment body complies with applicable children’s product safety rules, and PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 • Safeguarding against the exercise of undue influence on a third party conformity assessment body by a manufacturer or private labeler. In 2011, in response to the statutory direction, the Commission issued two regulations related to testing: 16 CFR part 1107, ‘‘Testing and Labeling Pertaining to Product Certification’’ (testing regulation or part 1107) and 16 CFR part 1109, ‘‘Conditions and Requirements for Relying on Component Part Testing or Certification, or Another Party’s Finished Product Certification, to Meet Testing and Certification Requirements’’ (component part regulation or part 1109). Part 1107 implements the above statutory provisions and specifies the records that must be kept to document the required testing and test results. Part 1109 specifies how manufacturers can use third party testing of component parts of products to certify the compliance of a finished product. The intent of the component part regulation was, in part, to provide flexibility to manufacturers and importers and to reduce the costs and other burdens of testing finished products. The regulation has specific requirements that apply to component part testing for lead, paint, and phthalates requirements. The component part regulation also sets forth requirements for importers and other suppliers for relying upon third party testing and certificates provided by their own suppliers. Finally, this part also specifies record-keeping requirements for the testing of the component parts, and requirements to provide traceability of how the component parts were used in finished products. When parts 1107 and 1109 were promulgated in 2011, the final regulatory flexibility analysis found that the third party testing requirements in part 1107 would have a significant economic impact on a substantial number of small entities. In contrast, the final regulatory flexibility analysis for the component part regulation in part 1109 found that the regulation would not likely have a significant impact on a substantial number of small entities because component part testing is not mandatory. Thus, the only companies expected to engage in component part testing are companies that believe it will be advantageous to do so. However, OMB determined that both 1107 and 1109 were considered major rules under the Congressional Review Act (CRA).1 1 The CRA defines a ‘‘major rule’’ as one that has resulted in or is likely to result in (1) an annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, E:\FR\FM\24AUP1.SGM 24AUP1 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Proposed Rules Accordingly, CPSC is conducting a 610 rule review for both regulations. jbell on DSKJLSW7X2PROD with PROPOSALS B. Efforts To Reduce Burden Generally and on Small Businesses The Commission has undertaken several burden-reduction efforts since promulgation of the testing and component part regulations. In August 2011, after the proposed testing and component part regulations had been published in the Federal Register, but before issuance of the final regulations, Congress passed Public Law 112–28 (August 12, 2011), ‘‘An Act to Provide the Consumer Product Safety Commission with Greater Authority and Discretion in Enforcing the Consumer Product Safety Laws, and for Other Purposes,’’ which amended various sections of the CPSIA. Among other things, Public Law 112–28 directed the CPSC to seek comment on ‘‘opportunities to reduce the cost of third party testing requirements consistent with assuring compliance with any applicable consumer product safety rule, ban, standard, or regulation.’’ Public Law 112–28 also authorized the Commission to issue new or revised third party testing regulations if the Commission determines ‘‘that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.’’ Id. 2063(d)(3)(B). In response to the statutory charge to pursue burden reduction in Public Law 112–28, the Commission has issued several regulations that make determinations that certain specified materials do not contain prohibited elements or chemicals in excess of the regulated limits, and therefore, component parts made from these materials do not require third party testing for certification. These include the following regulations for materials determinations: • That most fabrics used in apparel will not contain lead in excess of the regulated limits (16 CFR 1500.91 ‘‘Hazardous Substances and Articles: Administration and Enforcement Regulations’’); • That unfinished and untreated wood will not contain the heavy elements regulated by the mandatory toy standard ASTM F963 (16 CFR part individual industries, federal, state, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, or innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. 5 U.S.C. 804(2). VerDate Sep<11>2014 16:10 Aug 21, 2020 Jkt 250001 1251 ‘‘Toys: Determinations Regarding Heavy Elements Limits for Certain Materials’’); • That some manufactured wood will not contain lead, the chemicals regulated by the mandatory toy standard ASTM F963 and the prohibited phthalates (16 CFR part 1252 ‘‘Children’s Products, Children’s Toys, and Child Care Articles: Determinations Regarding Lead, ASTM F963 Elements, and Phthalates for Engineered Wood Products’’); • That some unfinished manufactured fibers will not contain the chemicals regulated by the toy standard and the prohibited phthalates (16 CFR part 1253 ‘‘Children’s Toys and Child Care Articles: Determinations Regarding ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers’’); and • That certain plastics will not contain the prohibited phthalates (16 CFR part 1308 ‘‘Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics’’). Although CPSC did not issue the above regulations only to address the impact of the testing regulations on small businesses, small businesses have benefitted from the determinations, often even more than their larger counterparts. In addition to the materials determinations regulations discussed above, the Commission has taken other steps to reduce the testing burdens imposed by 16 CFR part 1107 since promulgation of the regulation. In June 2017, the Commission issued a Request for Information (RFI), ‘‘Request for Information on Potentially Reducing Regulatory Burdens without Harming Consumers.’’ The RFI solicited stakeholder input regarding how to reduce burdens broadly, to include burdens from third party testing. CPSC has implemented several of the recommendations in the RFI regarding reducing third party testing burdens. CPSC has provided sample conformity certificates for use by manufactures and importers; developed a ‘‘regulatory robot’’ on the CPSC website to help small businesses determine the regulatory requirements that apply to their products; and provided additional outreach documents and plain language instructions for small manufacturers on how to comply with CPSC regulations. The Commission continues to explore opportunities to reduce unnecessary burdens related to third party testing requirements while assuring compliance with applicable children’s product safety rules. PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 52079 C. Review Under Section 610 of the Regulatory Flexibility Act Section 610(a) of the RFA requires agencies to review regulations within ten years after promulgation if they are expected to have a significant impact on a substantial number of small entities. Because the testing and component part regulations were issued in 2011, the Commission now requests comments to obtain additional information to inform its section 610 review of the testing regulations. 5 U.S.C. 610(a). The purpose of the review is to determine whether such rules should be continued without change, or should be amended, consistent with the stated objectives of applicable statutes, to minimize any significant impact of the rules on a substantial number of small entities. The RFA lists several factors that the agency shall consider when reviewing rules under section 610. These factors are: • The continued need for the rule; • The nature of complaints or comments received concerning the rule from the public; • The complexity of the rule; • The extent to which the rule overlaps, duplicates or conflicts with other Federal rules, and, to the extent feasible, with state and local governmental rules; and • The length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. 5 U.S.C. 610(b). The statute continues to require third party testing and certification of children’s products under section 14 of the CPSA, thus establishing the need for the testing and component part regulations. However, the Commission seeks comment to evaluate the other factors and to determine whether the ongoing impact of the testing and component part regulations are significant for a substantial number of small entities. An important step in the review process involves gathering and analyzing information from affected persons about their experience with the rules and any material changes in circumstances since issuance of the rules. The Commission requests written comments on the adequacy or inadequacy of the testing and component part regulations, their small business impacts, and other relevant issues. The purpose of these questions is to assist commenters in their responses and not to limit the format or substance of their comments. Comments are requested on all issues raised by Section 610 of the RFA. E:\FR\FM\24AUP1.SGM 24AUP1 52080 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Proposed Rules Safety and Effectiveness • Are there any sections of the testing and component part regulations that could be revised to be made less burdensome while still being consistent with assuring compliance? How would these suggested changes affect the burden on manufacturers and importers of children’s products, specifically small businesses? Explain your response and provide supporting data, if possible. jbell on DSKJLSW7X2PROD with PROPOSALS Costs and Impacts—Manufacturers and Importers of Children’s Products • Are there any requirements of the testing and component part regulations that are especially or unnecessarily costly and/or burdensome, particularly to small suppliers of children’s products? Please explain your response, and provide supporting data. • Which requirements in the testing and component part regulations have the greatest impact on testing costs? Which requirements have the lowest impact on testing costs? We are especially interested in any differential impact of the testing requirements on small businesses. Explain your response, and provide supporting data if possible. • The testing regulation provides general guidelines on what constitutes a sufficient number of samples to provide ‘‘a high degree of assurance that the tests conducted for certification purposes accurately demonstrate the ability of the children’s product to meet all applicable children’s product safety rules.’’ Is the current flexibility provided in the testing regulation for determining sample size helpful or burdensome to small businesses? Would more specific requirements on what constitutes an appropriate sample size reduce the burden on small businesses? • The testing regulation provides several options to meet the periodic testing requirements, including options to test whenever there is a material change, every year, every two years, or every three years. Given model lifecycles for children’s products that would lead to material changes, are these options sufficiently flexible for small businesses? Are there different options for ‘‘periodic testing’’ that could reduce the burden on small businesses and be consistent with assuring compliance with the applicable safety rules? • Do testing and component part regulations cause delays in bringing new products to market? Do these impacts particularly affect small businesses? Are there actions CPSC could take to reduce any delay caused by the testing and component part VerDate Sep<11>2014 16:10 Aug 21, 2020 Jkt 250001 regulations that would still be consistent with assuring compliance with all applicable safety rules? • Are there particular types of children’s products or small businesses that are substantially impacted by the testing and component part regulations? How could the regulations be revised to address these specific products or types of small businesses? Please provide data and specific examples to support your answer. Recordkeeping Requirements • Are the recordkeeping requirements in the testing and component part regulations inadequate, or overly burdensome for small businesses? • Could the recordkeeping requirements in the testing and component part regulations be changed in a way that would reduce the recordkeeping costs for small businesses and still be consistent with assuring compliance with all applicable safety rules? Please explain your response. Component Part Testing • Have manufacturers, importers, and private labelers, particularly small businesses, been using the flexibilities provided in the component part testing rule (16 CFR part 1109) to reduce their third party testing costs (e.g., relying upon third party testing provided by a supplier to certify products or relying on third party testing of a component part used in more than one model for certification purposes)? If so, in what way? Can you provide estimates of the cost savings provided by the component part regulation? • Are there particular requirements in the component part regulation that are especially burdensome to small businesses and that limit the ability of small businesses to take advantage of the opportunities for burden reduction that could be offered by the rule? If so, how could we revise the requirements to reduce the burden on small businesses while still assuring compliance with all applicable safety rules? • Have small businesses had difficulty identifying providers of certified component parts, such as paint, varnishes, fasteners, small parts, and fabrics? If so, are there ways CPSC could make it easier for small businesses to identify available providers of certified component parts? • The component part regulation has specific requirements for component part testing for lead, phthalates, and paint. Are these requirements clear? If not, how could we make them clearer to small businesses while still assuring PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 compliance with all applicable safety rules? Labeling Requirements in 16 CFR 1107 The testing regulation includes a subpart on labeling. The regulations specify that manufacturers and private labelers of consumer products may provide a label that the product ‘‘meets CPSC safety requirements.’’ Such a label is permitted but not required. • Are the labeling requirements clear? Could the testing regulation be revised to reduce the burden on small businesses or to increase the ability of small businesses to take advantage of the opportunity to label their products as being compliant with the CPSC safety requirements? Changes in Market Conditions Since 2011 • How have market conditions for children’s products changed since 2011 for small businesses? Should the testing and component part regulations change to address these market changes? If so, how? • Could the testing and component part regulations be changed to address advances in testing technology that have occurred since 2011 that would reduce the burden on small businesses? • Are there new categories of children’s products that have entered the market since 2011 for which the testing and component part regulations are particularly burdensome on small businesses? Outreach and Advocacy • Are the requirements in CPSC’s testing and component part regulations well understood by businesses that manufacture or import children’s products, particularly small businesses and businesses that build or import children’s products infrequently or in small lots? How could the requirements of the testing and component part regulations be more effectively communicated to such businesses? • CPSC has provided a small business ‘‘regulatory robot’’ and sample Children’s Product Certificates and General Certificates of Conformity, among other tools. We conduct periodic free webinars for small businesses. Our website has a list of all the accredited testing labs, which has been updated to make it more easily searchable. Are there other documents, instructional videos, or information of the above nature we could provide that would help small firms comply with the testing and component part regulations? E:\FR\FM\24AUP1.SGM 24AUP1 Federal Register / Vol. 85, No. 164 / Monday, August 24, 2020 / Proposed Rules Overall Burden of the Testing and Component Part Regulations on Small Businesses • To what extent, if any, have children’s product manufacturers increased their use of third party testing in response to the third party testing requirements in section 14 of the CPSA and 16 CFR parts 1107 and 1109? Did third party testing replace other types of testing or quality assurance activities that the manufacturers or importers had been using to ensure that their products complied with the applicable product safety rules? • Is it possible to estimate the overall burden of the testing and component part regulations, perhaps as a percentage of revenue, over and above what businesses would have spent to ensure compliance with the applicable product safety rules in the absence of the testing and component part regulation? Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2020–16441 Filed 8–21–20; 8:45 am] BILLING CODE 6355–01–P FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1075. SUPPLEMENTARY INFORMATION: In the Federal Register of May 8, 2019 (84 FR 20060), we announced that we had filed a color additive petition (CAP 9C0315), submitted by CooperVision, 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. The petition proposed to amend the color additive regulations in 21 CFR part 73, Listing of Color Additives Exempt from Certification, to provide for the safe use of disperse orange 3 methacrylamide (CAS Reg. 58142–15–7; CAS name 2-propenamide, 2-methyl-N[4-[2-(4-nitrophenyl)diazenyl]phenyl]-) as a color additive in silicone-based hydrogel contact lenses. The color additive was intended to copolymerize with various monomers in the contact lens formulation to produce colored contact lenses. Through this notice, we are announcing that CooperVision has withdrawn the petition without prejudice to a future filing (21 CFR 71.6(c)(2)). Dated: July 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2020–17195 Filed 8–21–20; 8:45 am] Food and Drug Administration BILLING CODE 4164–01–P 21 CFR Part 73 [Docket No. FDA–2019–C–1782] DEPARTMENT OF DEFENSE CooperVision, Inc.; Withdrawal of Color Additive Petition GENERAL SERVICES ADMINISTRATION AGENCY: Food and Drug Administration, HHS. Notification; withdrawal of petition. ACTION: jbell on DSKJLSW7X2PROD with PROPOSALS 48 CFR Part 7 The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a color additive petition (CAP 9C0315) proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide as a color additive in contact lenses. DATES: The color additive petition was withdrawn on June 15, 2020. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number found in brackets in the heading of this document into the ‘‘Search’’ box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. SUMMARY: VerDate Sep<11>2014 16:10 Aug 21, 2020 Jkt 250001 NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [FAR Case 2019–001, Docket No. FAR– 2019–0020, Sequence No. 1] RIN 9000–AN84 Federal Acquisition Regulation: Analysis for Equipment Acquisitions Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA). ACTION: Proposed rule. AGENCY: DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement a section of the FAA Reauthorization Act of 2018, which requires, when acquiring equipment, a case-by-case analysis of cost and other factors associated with certain methods of acquisition, including purchase, SUMMARY: PO 00000 Frm 00024 Fmt 4702 Sfmt 4702 52081 short-term rental or lease, long-term rental or lease, interagency acquisition, and, if applicable, acquisition agreements with a State or local government. DATES: Interested parties should submit written comments at the address shown below on or before October 23, 2020 to be considered in the formation of the final rule. ADDRESSES: Submit comments in response to FAR Case 2019–001 to Regulations.gov: https:// www.regulations.gov. Submit comments via the Federal eRulemaking portal by searching for ‘‘FAR Case 2019–001’’. Select the link ‘‘Comment Now’’ that corresponds with FAR Case 2019–001. Follow the instructions provided at the ‘‘Comment Now’’ screen. Please include your name, company name (if any), and ‘‘FAR Case 2019–001’’ on your attached document. If your comment cannot be submitted using https:// www.regulations.gov, call or email the points of contact in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Instructions: Please submit comments only and cite ‘‘FAR case 2019–001’’ in all correspondence related to this case. All comments received will be posted without change to https:// www.regulations.gov, including any personal and/or business confidential information provided. FOR FURTHER INFORMATION CONTACT: Mr. Michael O. Jackson, Procurement Analyst, at 202–208–4949, or by email at michaelo.jackson@gsa.gov, for clarification of content. For information pertaining to status or publication schedules, contact the Regulatory Secretariat Division at 202–501–4755 or GSARegSec@gsa.gov. Please cite FAR case 2019–001. SUPPLEMENTARY INFORMATION: I. Background On July 16, 2013, DoD, GSA, and NASA published a Request for Information (RFI) in the Federal Register (78 FR 42524) to determine whether there is a distinction between renting and leasing that is useful for the purposes of FAR subpart 7.4. The public comment period closed in September 2013 and 13 respondents provided comments in response to the RFI. A review of the public comments identified that there are differences between renting and leasing in many industries, but there are no standard differences between renting and leasing that span across all industries. As a result of the review, FAR case 2017–017 was opened to clarify the term ‘‘lease’’, as used in the FAR and a proposed rule E:\FR\FM\24AUP1.SGM 24AUP1

Agencies

[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Proposed Rules]
[Pages 52078-52081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16441]



[[Page 52078]]

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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Parts 1107 and 1109

[Docket No. CPSC-2020-0019]


Regulatory Flexibility Act Section 610 Review of the Testing and 
Labeling Regulations Pertaining to Product Certification of Children's 
Products, Including Reliance on Component Part Testing

AGENCY: Consumer Product Safety Commission.

ACTION: Notification of section 610 review and request for comments.

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

SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is 
conducting a review of the regulations for third party testing and 
certification to demonstrate compliance with safety standards for 
children's products, under section 610 of the Regulatory Flexibility 
Act (RFA). That section requires the CPSC to review within 10 years 
after their issuance regulations that have a significant economic 
impact on a substantial number of small entities. The testing and 
component part regulations were promulgated in 2011. The CPSC seeks 
comment to determine whether, consistent with the CPSC's statutory 
obligations, these regulations should be maintained without change, or 
modified to minimize the significant impact of the rules on a 
substantial number of small entities.

DATES: Written comments should be submitted by October 23, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2020-
0019, 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 CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov. The CPSC encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Mail/hand delivery/courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer 
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, 
MD 20814; telephone: (301) 504-7479; email: [email protected].
    Instructions: All submissions must include the agency name and 
docket number for this notice. CPSC may post all comments received 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: https://www.regulations.gov. Do not submit electronically: confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. If you wish to submit such information, please submit it 
according to the instructions for written submissions.
    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-2020-0019, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Susan Proper, Directorate for Economic 
Analysis, Consumer Product Safety Commission, 4330 East West Highway, 
Bethesda, MD 20814; telephone: (301) 504-7628; email: [email protected].

SUPPLEMENTARY INFORMATION:

A. The Current Regulations in 16 CFR Parts 1107 and 1109

    Section 14 of the Consumer Product Safety Act (CPSA), as amended by 
the Consumer Product Safety Improvement Act of 2008 (CPSIA) and Public 
Law 112-28 (2011), establishes requirements for the testing and 
certification of products subject to consumer product safety rules 
under the CPSA, or similar rules, bans, standards, or regulations, 
under any other Act enforced by the Commission. The domestic 
manufacturer or the importer of the product must issue a certificate 
that the product complies with applicable safety standards. Under 
section 14(a)(2) of the CPSA, the certification of children's products 
must be based on testing conducted by an accredited third party 
conformity assessment body (a third party testing laboratory). Section 
14(i)(2) of the CPSA directed the Commission to publish a regulation 
that would ``initiate a program by which a manufacturer or private 
labeler may label a consumer product as complying with the 
certification requirements'' and to establish protocols and standards 
for:
     Ensuring that a children's product is subject to testing 
periodically and when there has been a material change in the product's 
design or manufacturing process, and
     The testing of representative samples to ensure continued 
compliance, and
     Verifying that a children's product tested by a conformity 
assessment body complies with applicable children's product safety 
rules, and
     Safeguarding against the exercise of undue influence on a 
third party conformity assessment body by a manufacturer or private 
labeler.
    In 2011, in response to the statutory direction, the Commission 
issued two regulations related to testing: 16 CFR part 1107, ``Testing 
and Labeling Pertaining to Product Certification'' (testing regulation 
or part 1107) and 16 CFR part 1109, ``Conditions and Requirements for 
Relying on Component Part Testing or Certification, or Another Party's 
Finished Product Certification, to Meet Testing and Certification 
Requirements'' (component part regulation or part 1109). Part 1107 
implements the above statutory provisions and specifies the records 
that must be kept to document the required testing and test results. 
Part 1109 specifies how manufacturers can use third party testing of 
component parts of products to certify the compliance of a finished 
product. The intent of the component part regulation was, in part, to 
provide flexibility to manufacturers and importers and to reduce the 
costs and other burdens of testing finished products. The regulation 
has specific requirements that apply to component part testing for 
lead, paint, and phthalates requirements. The component part regulation 
also sets forth requirements for importers and other suppliers for 
relying upon third party testing and certificates provided by their own 
suppliers. Finally, this part also specifies record-keeping 
requirements for the testing of the component parts, and requirements 
to provide traceability of how the component parts were used in 
finished products.
    When parts 1107 and 1109 were promulgated in 2011, the final 
regulatory flexibility analysis found that the third party testing 
requirements in part 1107 would have a significant economic impact on a 
substantial number of small entities. In contrast, the final regulatory 
flexibility analysis for the component part regulation in part 1109 
found that the regulation would not likely have a significant impact on 
a substantial number of small entities because component part testing 
is not mandatory. Thus, the only companies expected to engage in 
component part testing are companies that believe it will be 
advantageous to do so. However, OMB determined that both 1107 and 1109 
were considered major rules under the Congressional Review Act 
(CRA).\1\

[[Page 52079]]

Accordingly, CPSC is conducting a 610 rule review for both regulations.
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    \1\ The CRA defines a ``major rule'' as one that has resulted in 
or is likely to result in (1) an annual effect on the economy of 
$100 million or more; (2) a major increase in costs or prices for 
consumers, individual industries, federal, state, or local 
government agencies, or geographic regions; or (3) significant 
adverse effects on competition, employment, investment, 
productivity, or innovation, or on the ability of United States-
based enterprises to compete with foreign-based enterprises in 
domestic and export markets. 5 U.S.C. 804(2).
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B. Efforts To Reduce Burden Generally and on Small Businesses

    The Commission has undertaken several burden-reduction efforts 
since promulgation of the testing and component part regulations. In 
August 2011, after the proposed testing and component part regulations 
had been published in the Federal Register, but before issuance of the 
final regulations, Congress passed Public Law 112-28 (August 12, 2011), 
``An Act to Provide the Consumer Product Safety Commission with Greater 
Authority and Discretion in Enforcing the Consumer Product Safety Laws, 
and for Other Purposes,'' which amended various sections of the CPSIA. 
Among other things, Public Law 112-28 directed the CPSC to seek comment 
on ``opportunities to reduce the cost of third party testing 
requirements consistent with assuring compliance with any applicable 
consumer product safety rule, ban, standard, or regulation.'' Public 
Law 112-28 also authorized the Commission to issue new or revised third 
party testing regulations if the Commission determines ``that such 
regulations will reduce third party testing costs consistent with 
assuring compliance with the applicable consumer product safety rules, 
bans, standards, and regulations.'' Id. 2063(d)(3)(B).
    In response to the statutory charge to pursue burden reduction in 
Public Law 112-28, the Commission has issued several regulations that 
make determinations that certain specified materials do not contain 
prohibited elements or chemicals in excess of the regulated limits, and 
therefore, component parts made from these materials do not require 
third party testing for certification. These include the following 
regulations for materials determinations:
     That most fabrics used in apparel will not contain lead in 
excess of the regulated limits (16 CFR 1500.91 ``Hazardous Substances 
and Articles: Administration and Enforcement Regulations'');
     That unfinished and untreated wood will not contain the 
heavy elements regulated by the mandatory toy standard ASTM F963 (16 
CFR part 1251 ``Toys: Determinations Regarding Heavy Elements Limits 
for Certain Materials'');
     That some manufactured wood will not contain lead, the 
chemicals regulated by the mandatory toy standard ASTM F963 and the 
prohibited phthalates (16 CFR part 1252 ``Children's Products, 
Children's Toys, and Child Care Articles: Determinations Regarding 
Lead, ASTM F963 Elements, and Phthalates for Engineered Wood 
Products'');
     That some unfinished manufactured fibers will not contain 
the chemicals regulated by the toy standard and the prohibited 
phthalates (16 CFR part 1253 ``Children's Toys and Child Care Articles: 
Determinations Regarding ASTM F963 Elements and Phthalates for 
Unfinished Manufactured Fibers''); and
     That certain plastics will not contain the prohibited 
phthalates (16 CFR part 1308 ``Prohibition of Children's Toys and Child 
Care Articles Containing Specified Phthalates: Determinations Regarding 
Certain Plastics'').
    Although CPSC did not issue the above regulations only to address 
the impact of the testing regulations on small businesses, small 
businesses have benefitted from the determinations, often even more 
than their larger counterparts.
    In addition to the materials determinations regulations discussed 
above, the Commission has taken other steps to reduce the testing 
burdens imposed by 16 CFR part 1107 since promulgation of the 
regulation. In June 2017, the Commission issued a Request for 
Information (RFI), ``Request for Information on Potentially Reducing 
Regulatory Burdens without Harming Consumers.'' The RFI solicited 
stakeholder input regarding how to reduce burdens broadly, to include 
burdens from third party testing. CPSC has implemented several of the 
recommendations in the RFI regarding reducing third party testing 
burdens. CPSC has provided sample conformity certificates for use by 
manufactures and importers; developed a ``regulatory robot'' on the 
CPSC website to help small businesses determine the regulatory 
requirements that apply to their products; and provided additional 
outreach documents and plain language instructions for small 
manufacturers on how to comply with CPSC regulations. The Commission 
continues to explore opportunities to reduce unnecessary burdens 
related to third party testing requirements while assuring compliance 
with applicable children's product safety rules.

C. Review Under Section 610 of the Regulatory Flexibility Act

    Section 610(a) of the RFA requires agencies to review regulations 
within ten years after promulgation if they are expected to have a 
significant impact on a substantial number of small entities. Because 
the testing and component part regulations were issued in 2011, the 
Commission now requests comments to obtain additional information to 
inform its section 610 review of the testing regulations. 5 U.S.C. 
610(a). The purpose of the review is to determine whether such rules 
should be continued without change, or should be amended, consistent 
with the stated objectives of applicable statutes, to minimize any 
significant impact of the rules on a substantial number of small 
entities. The RFA lists several factors that the agency shall consider 
when reviewing rules under section 610. These factors are:
     The continued need for the rule;
     The nature of complaints or comments received concerning 
the rule from the public;
     The complexity of the rule;
     The extent to which the rule overlaps, duplicates or 
conflicts with other Federal rules, and, to the extent feasible, with 
state and local governmental rules; and
     The length of time since the rule has been evaluated or 
the degree to which technology, economic conditions, or other factors 
have changed in the area affected by the rule.

5 U.S.C. 610(b).
    The statute continues to require third party testing and 
certification of children's products under section 14 of the CPSA, thus 
establishing the need for the testing and component part regulations. 
However, the Commission seeks comment to evaluate the other factors and 
to determine whether the ongoing impact of the testing and component 
part regulations are significant for a substantial number of small 
entities. An important step in the review process involves gathering 
and analyzing information from affected persons about their experience 
with the rules and any material changes in circumstances since issuance 
of the rules. The Commission requests written comments on the adequacy 
or inadequacy of the testing and component part regulations, their 
small business impacts, and other relevant issues. The purpose of these 
questions is to assist commenters in their responses and not to limit 
the format or substance of their comments. Comments are requested on 
all issues raised by Section 610 of the RFA.

[[Page 52080]]

Safety and Effectiveness

     Are there any sections of the testing and component part 
regulations that could be revised to be made less burdensome while 
still being consistent with assuring compliance? How would these 
suggested changes affect the burden on manufacturers and importers of 
children's products, specifically small businesses? Explain your 
response and provide supporting data, if possible.

Costs and Impacts--Manufacturers and Importers of Children's Products

     Are there any requirements of the testing and component 
part regulations that are especially or unnecessarily costly and/or 
burdensome, particularly to small suppliers of children's products? 
Please explain your response, and provide supporting data.
     Which requirements in the testing and component part 
regulations have the greatest impact on testing costs? Which 
requirements have the lowest impact on testing costs? We are especially 
interested in any differential impact of the testing requirements on 
small businesses. Explain your response, and provide supporting data if 
possible.
     The testing regulation provides general guidelines on what 
constitutes a sufficient number of samples to provide ``a high degree 
of assurance that the tests conducted for certification purposes 
accurately demonstrate the ability of the children's product to meet 
all applicable children's product safety rules.'' Is the current 
flexibility provided in the testing regulation for determining sample 
size helpful or burdensome to small businesses? Would more specific 
requirements on what constitutes an appropriate sample size reduce the 
burden on small businesses?
     The testing regulation provides several options to meet 
the periodic testing requirements, including options to test whenever 
there is a material change, every year, every two years, or every three 
years. Given model lifecycles for children's products that would lead 
to material changes, are these options sufficiently flexible for small 
businesses? Are there different options for ``periodic testing'' that 
could reduce the burden on small businesses and be consistent with 
assuring compliance with the applicable safety rules?
     Do testing and component part regulations cause delays in 
bringing new products to market? Do these impacts particularly affect 
small businesses? Are there actions CPSC could take to reduce any delay 
caused by the testing and component part regulations that would still 
be consistent with assuring compliance with all applicable safety 
rules?
     Are there particular types of children's products or small 
businesses that are substantially impacted by the testing and component 
part regulations? How could the regulations be revised to address these 
specific products or types of small businesses? Please provide data and 
specific examples to support your answer.

Recordkeeping Requirements

     Are the recordkeeping requirements in the testing and 
component part regulations inadequate, or overly burdensome for small 
businesses?
     Could the recordkeeping requirements in the testing and 
component part regulations be changed in a way that would reduce the 
recordkeeping costs for small businesses and still be consistent with 
assuring compliance with all applicable safety rules? Please explain 
your response.

Component Part Testing

     Have manufacturers, importers, and private labelers, 
particularly small businesses, been using the flexibilities provided in 
the component part testing rule (16 CFR part 1109) to reduce their 
third party testing costs (e.g., relying upon third party testing 
provided by a supplier to certify products or relying on third party 
testing of a component part used in more than one model for 
certification purposes)? If so, in what way? Can you provide estimates 
of the cost savings provided by the component part regulation?
     Are there particular requirements in the component part 
regulation that are especially burdensome to small businesses and that 
limit the ability of small businesses to take advantage of the 
opportunities for burden reduction that could be offered by the rule? 
If so, how could we revise the requirements to reduce the burden on 
small businesses while still assuring compliance with all applicable 
safety rules?
     Have small businesses had difficulty identifying providers 
of certified component parts, such as paint, varnishes, fasteners, 
small parts, and fabrics? If so, are there ways CPSC could make it 
easier for small businesses to identify available providers of 
certified component parts?
     The component part regulation has specific requirements 
for component part testing for lead, phthalates, and paint. Are these 
requirements clear? If not, how could we make them clearer to small 
businesses while still assuring compliance with all applicable safety 
rules?

Labeling Requirements in 16 CFR 1107

    The testing regulation includes a subpart on labeling. The 
regulations specify that manufacturers and private labelers of consumer 
products may provide a label that the product ``meets CPSC safety 
requirements.'' Such a label is permitted but not required.
     Are the labeling requirements clear? Could the testing 
regulation be revised to reduce the burden on small businesses or to 
increase the ability of small businesses to take advantage of the 
opportunity to label their products as being compliant with the CPSC 
safety requirements?

Changes in Market Conditions Since 2011

     How have market conditions for children's products changed 
since 2011 for small businesses? Should the testing and component part 
regulations change to address these market changes? If so, how?
     Could the testing and component part regulations be 
changed to address advances in testing technology that have occurred 
since 2011 that would reduce the burden on small businesses?
     Are there new categories of children's products that have 
entered the market since 2011 for which the testing and component part 
regulations are particularly burdensome on small businesses?

Outreach and Advocacy

     Are the requirements in CPSC's testing and component part 
regulations well understood by businesses that manufacture or import 
children's products, particularly small businesses and businesses that 
build or import children's products infrequently or in small lots? How 
could the requirements of the testing and component part regulations be 
more effectively communicated to such businesses?
     CPSC has provided a small business ``regulatory robot'' 
and sample Children's Product Certificates and General Certificates of 
Conformity, among other tools. We conduct periodic free webinars for 
small businesses. Our website has a list of all the accredited testing 
labs, which has been updated to make it more easily searchable. Are 
there other documents, instructional videos, or information of the 
above nature we could provide that would help small firms comply with 
the testing and component part regulations?

[[Page 52081]]

Overall Burden of the Testing and Component Part Regulations on Small 
Businesses

     To what extent, if any, have children's product 
manufacturers increased their use of third party testing in response to 
the third party testing requirements in section 14 of the CPSA and 16 
CFR parts 1107 and 1109? Did third party testing replace other types of 
testing or quality assurance activities that the manufacturers or 
importers had been using to ensure that their products complied with 
the applicable product safety rules?
     Is it possible to estimate the overall burden of the 
testing and component part regulations, perhaps as a percentage of 
revenue, over and above what businesses would have spent to ensure 
compliance with the applicable product safety rules in the absence of 
the testing and component part regulation?

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2020-16441 Filed 8-21-20; 8:45 am]
BILLING CODE 6355-01-P
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