PART 1107—TESTING AND LABELING PERTAINING TO PRODUCT CERTIFICATION Authority: 15 U.S.C. 2063, Sec. 3, 102 Pub. L. 110-314, 122 Stat. 3016, 3017, 3022. Source: 76 FR 69541, Nov. 8, 2011, unless otherwise noted. Subpart A—General Provisions § 1107.1 Purpose. This part establishes the protocols and standards for ensuring continued testing of children's products periodically and when there has been a material change in the product's design or manufacturing process and safeguarding against the exercise of undue influence by a manufacturer on a third party conformity assessment body. It also establishes a program for labeling of consumer products to indicate that the certification requirements have been met pursuant to sections 14(a)(2) and (i)(2)(B) of the Consumer Product Safety Act (CPSA) (15 U.S.C. 2063(a)(2) and (i)(2)(B)). § 1107.2 Definitions. Unless otherwise stated, the definitions of the Consumer Product Safety Act and the Consumer Product Safety Improvement Act of 2008 apply to this part. The following definitions apply for purposes of this part: CPSA CPSC Due care High degree of assurance Identical in all material respects Manufacturer Manufacturing process Material change Third party conformity assessment body Subpart B [Reserved] Subpart C—Certification of Children's Products § 1107.20 General requirements. (a) Manufacturers must submit a sufficient number of samples of a children's product, or samples that are identical in all material respects to the children's product, to a third party conformity assessment body for testing to support certification. The number of samples selected must be sufficient 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. (b) If the manufacturing process for a children's product consistently creates finished products that are uniform in composition and quality, a manufacturer may submit fewer samples to provide a high degree of assurance that the finished product complies with the applicable children's product safety rules. If the manufacturing process for a children's product results in variability in the composition or quality of children's products, a manufacturer may need to submit more samples to provide a high degree of assurance that the finished product complies with the applicable children's product safety rules. (c) Except where otherwise specified by a children's product safety rule, component part testing pursuant to 16 CFR part 1109 may be used to support the certification testing requirements of this section. (d) If a product sample fails certification testing to the applicable children's product safety rule(s), even if other samples have passed the same certification test, the manufacturer must investigate the reasons for the failure and take the necessary steps to address the reasons for the failure. A manufacturer cannot certify the children's product until the manufacturer establishes, with a high degree of assurance that the finished product does comply with all applicable children's product safety rules. § 1107.21 Periodic testing. (a) General requirements for all manufacturers. (b) A manufacturer must conduct periodic testing to ensure compliance with the applicable children's product safety rules at least once a year, except as otherwise provided in paragraphs (c), and (d) of this section or as provided in regulations under this title. If a manufacturer does not conduct production testing under paragraph (c) of this section, or testing by a testing laboratory under paragraph (d) of this section, the manufacturer must conduct periodic testing as follows: (1) Periodic Testing Plan. (2) Testing Interval. (i) High variability in test results, as indicated by a relatively large sample standard deviation in quantitative tests; (ii) Measurements that are close to the allowable numerical limit for quantitative tests; (iii) Known manufacturing process factors which could affect compliance with a rule. For example, if the manufacturer knows that a casting die wears down as the die nears the end of its useful life, the manufacturer may wish to test more often as the casting die wears down; (iv) Consumer complaints or warranty claims; (v) Introduction of a new set of component parts into the assembly process; (vi) The manufacture of a fixed number of products; (vii) Potential for serious injury or death resulting from a noncompliant children's product; (viii) The number of children's products produced annually, such that a manufacturer should consider testing a children's product more frequently if the product is produced in very large numbers or distributed widely throughout the United States; (ix) The children's product's similarity to other children's products with which the manufacturer is familiar and/or whether the children's product has many different component parts compared to other children's products of a similar type; or (x) Inability to determine the children's product's noncompliance easily through means such as visual inspection. (c)(1) If a manufacturer implements a production testing plan as described in paragraph (c)(2) of this section to ensure continued compliance of the children's product with a high degree of assurance to the applicable children's product safety rules, the manufacturer must submit samples of its children's product to a third party conformity assessment body for periodic testing to the applicable children's product safety rules at least once every two years. A manufacturer may consider the information obtained from production testing when determining the appropriate testing interval and the number of samples needed for periodic testing to ensure that there is a high degree of assurance that the other untested children's products manufactured during the testing interval comply with the applicable children's product safety rules. (2) Production Testing Plan. (i) A description of the production testing plan, including, but not limited to, a description of the process management techniques used, the tests to be conducted, or the measurements to be taken; the intervals at which the tests or measurements will be made; the number of samples tested; and the basis for determining that the combination of process management techniques and tests provide a high degree of assurance of compliance if they are not the tests prescribed for the applicable children's product safety rule; (ii) At each manufacturing site, the manufacturer must have a production testing plan specific to each children's product manufactured at that site; (iii) The production testing interval selected for tests must ensure that, if the samples selected for production testing comply with an applicable children's product safety rule, there is a high degree of assurance that the untested products manufactured during that testing interval also will comply with the applicable children's product safety rule. Production testing intervals should be appropriate for the specific testing or alternative measurements being conducted. (3) If a production testing plan as described in this paragraph (c) fails to provide a high degree of assurance of compliance with all applicable children's product safety rules, the CPSC may require the manufacturer to meet the requirements of paragraph (b) of this section or modify its production testing plan to ensure a high degree of assurance of compliance. (d)(1) For manufacturers conducting testing to ensure continued compliance with the applicable children's product safety rules using a testing laboratory accredited to ISO/IEC 17025, “General requirements for the competence of testing and calibration laboratories,” periodic tests by a third party conformity assessment body must be conducted at least once every three years. Any ISO/IEC 17025 -accredited testing laboratory used for ensuring continued compliance must be accredited by an accreditation body that is accredited to ISO/IEC 17011, “Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies.” The test method(s) used by an ISO/IEC 17025-accredited testing laboratory when conducting testing to ensure continued compliance must be the same test method(s) used for certification to the applicable children's product safety rules. Manufacturers must conduct testing using the ISO/IEC 17025-accredited testing laboratory frequently enough to provide a high degree of assurance that the children's product continues to comply with the applicable children's product safety rules. A manufacturer may consider the information obtained from testing conducted by an ISO/IEC 17025-accredited testing laboratory when determining the appropriate testing interval and the number of samples for periodic testing that are needed to ensure that there is a high degree of assurance that the other untested children's products manufactured during the testing interval comply with the applicable children's product safety rules. (2) If the continued testing described in paragraph (d)(1) of this section fails to provide a high degree of assurance of compliance with all applicable children's product safety rules, the CPSC may require the manufacturer to meet the requirements of paragraph (b) of this section or modify the testing frequency or number of samples required to ensure a high degree of assurance of continued compliance. (e) [Reserved] (f) A manufacturer must select representative product samples to be submitted to the third party conformity assessment body for periodic testing. The procedure used to select representative product samples for periodic testing must provide a basis for inferring compliance about the population of untested products produced during the applicable periodic testing interval. The number of samples selected for the sampling procedure must be sufficient to ensure continuing compliance with all applicable children's product safety rules. The manufacturer must document the procedure used to select the product samples for periodic testing and the basis for inferring the compliance of the product manufactured during the periodic testing interval from the results of the tested samples. (g) Incorporation by reference. [email protected], [email protected], www.archives.gov/federal-register/cfr/ibr-locations.html. (1) International Organization for Standardization (ISO), ISO Central Secretariat Chemin de Blandonnet 8 CP 401—1214 Vernier, Geneva, Switzerland; Telephone + 41 22 749 01 11, Fax + 41 22 733 34 30; http://www.iso.org/iso/home.htm. (i) ISO/IEC 17011:2017(E) (ISO/IEC 17011), “Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies,” November 10, 2017; and (ii) ISO/IEC 17025:2017(E) (ISO/IEC 17025), “General requirements for the competence of testing and calibration laboratories,” November 10, 2017. (2) [Reserved] [76 FR 69541, Nov. 8, 2011, as amended at 77 FR 72219, Dec. 5, 2012; 86 FR 22866, Apr. 30, 2021] § 1107.23 Material change. (a) General Requirements. (b) Product Design. (c) Manufacturing Process. (d) Sourcing of Component Parts. § 1107.24 Undue influence. (a) Each manufacturer must establish procedures to safeguard against the exercise of undue influence by a manufacturer on a third party conformity assessment body. (b) The procedures required in paragraph (a) of this section, at a minimum, must include: (1) Safeguards to prevent attempts by the manufacturer to exercise undue influence on a third party conformity assessment body, including a written policy statement from company officials that the exercise of undue influence is not acceptable, and directing that every appropriate staff member receive training on avoiding undue influence, and sign a statement attesting to participation in such training; (2) A requirement that upon substantive changes to the requirements in this section regarding avoiding undue influence, the appropriate staff must be retrained regarding those changed requirements. (3) A requirement to notify the CPSC immediately of any attempt by the manufacturer to hide or exert undue influence over test results; and (4) A requirement to inform employees that allegations of undue influence may be reported confidentially to the CPSC and a description of the manner in which such a report can be made. § 1107.26 Recordkeeping. (a) A manufacturer of a children's product subject to an applicable children's product safety rule must maintain the following records: (1) A copy of the Children's Product Certificate for each product. The children's product covered by the certificate must be clearly identifiable and distinguishable from other products; (2) Records of each third party certification test. The manufacturer must have separate certification tests records for each manufacturing site; (3) Records of one of the following for periodic tests of a children's product: (i) A periodic test plan and periodic test results; (ii) A production testing plan, production test results, and periodic test results; or (iii) Testing results of tests conducted by a testing laboratory accredited to ISO/IEC 17025 (see § 1107.21 for availability) and periodic test results. (4) Records documenting the testing of representative samples, as set forth in § 1107.21(f), including the number of representative samples selected and the procedure used to select representative samples. Records also must include the basis for inferring compliance of the product manufactured during the periodic testing interval from the results of the tested samples; (5) Records of descriptions of all material changes in product design, manufacturing process, and sourcing of component parts, and the certification tests run and the test values; and (6) Records of the undue influence procedures, including training materials and training records of all employees trained on these procedures, including attestations described at § 1107.24(b)(1). (b) A manufacturer must maintain the records specified in paragraph (a) of this section for five years. The manufacturer must make these records available, either in hard copy or electronically, such as through an Internet Web site, for inspection by the CPSC upon request. Records may be maintained in languages other than English if they can be: (1) Provided immediately by the manufacturer to the CPSC; and (2) Translated accurately into English by the manufacturer within 48 hours of a request by the CPSC, or any longer period negotiated with CPSC staff. [76 FR 69541, Nov. 8, 2011, as amended at 77 FR 72219, Dec. 5, 2012; 86 FR 22866, Apr. 30, 2021] Subpart D—Consumer Product Labeling Program § 1107.30 Labeling consumer products to indicate that the certification requirements of section 14 of the CPSA have been met. (a) Manufacturers and private labelers of a consumer product may indicate, by a uniform label on, or provided with the product, that the product complies with any consumer product safety rule under the CPSA, or with any similar rule, ban, standard or regulation under any other act enforced by the CPSC. (b) The label must be visible and legible, and consist of the following statement: Meets CPSC Safety Requirements (c) A consumer product may bear the label if the manufacturer or private labeler has certified, pursuant to section 14 of the CPSA, that the consumer product complies with all applicable consumer product safety rules under the CPSA and with all rules, bans, standards, or regulations applicable to the product under any other act enforced by the Consumer Product Safety Commission. (d) A manufacturer or private labeler may use a label in addition to the label described in paragraph (b) on the consumer product, as long as such label does not alter or mislead consumers as to the meaning of the label described in paragraph (b) of this section. A manufacturer or private labeler must not imply that the CPSC has tested, approved, or endorsed the product.