ThirdPartyConformityAssessmentBodies_Supporting Statement Part A_2025

SUPPORTING STATEMENT - PART A

Information Collection Request

Requirements Pertaining to Third Party Conformity Assessment Bodies

OMB Control Number 3041-0156

1. Need for the Information Collection

Section 14(a)(2) of the Consumer Product Safety Act (“CPSA”), 15 U.S.C. 2063(a)(2), requires manufacturers and private labelers of any children’s product that is subject to a children’s product safety rule to submit samples of the product, or samples that are identical in all material respects to the product, to a third party conformity assessment body accredited by the U.S. Consumer Product Safety Commission (“CPSC” or “Commission”) to be tested for compliance with such children’s product safety rule.

Section 14(a)(3)(C) of the CPSA, as amended by section 102 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the Commission to accredit third party conformity assessment bodies or designate an independent accreditation organization.

Section 14(e) of the CPSA authorizes the Commission to withdraw the accreditation or acceptance of accreditation of a third party conformity assessment body if:

• a manufacturer, private labeler, or governmental entity has exerted undue influence on such conformity assessment body or otherwise interfered with or compromised the integrity of the testing process with respect to the certification of a children's product; or

• such conformity assessment body failed to comply with an applicable protocol, standard, or requirement established by the Commission.

Section 14(e)(3) of the CPSA authorizes the Commission to suspend the accreditation of a conformity assessment body if it fails to cooperate with the Commission in an investigation.

Section 14(f)(2)(B) of the CPSA lists additional requirements for including governmental third party conformity assessment bodies as CPSC-accepted third party conformity assessment bodies.

Section 14(f)(2)(D) of the CPSA lists additional requirements for including firewalled third party conformity assessment bodies as CPSC-accepted third party conformity assessment bodies.

Section 14(i)(1) requires the CPSC to establish requirements for the periodic audit of third party conformity assessment bodies as a condition for the continuing accreditation or acceptance of accreditation of such conformity assessment bodies.

The rule is codified at 16 CFR part 1112. This rule establishes the accreditation and audit requirements for third party conformity assessment bodies so that their testing results may be used as a basis for a manufacturer to issue a Children’s Product Certificate.¹ This rule establishes procedures by which a third party conformity assessment body may have its CPSC acceptance of that accreditation withdrawn or suspended. Additionally, the rule codifies the notices of requirements third party conformity assessment bodies need to meet in order to have their accreditation accepted by the Commission for test methods for children’s products certification, and includes new or modified notices of requirements.

The rule does not require the records to be available in the English language if they can be provided to the CPSC within 48 hours and translated into English within 30 days of a request by the CPSC. The documentation and records are needed to enable the Commission to investigate manufacturers if noncomplying yet certified products are found or to investigate an allegation of undue influence on the third party conformity assessment body.

2. Use of the Information

The recordkeeping requirements are intended to allow a third party conformity assessment body to support a manufacturer’s claim that children’s products are properly tested before being certified and entered in commerce, and have been properly retested for conformity with all applicable rules on a continuing basis.

3. Use of Information Technology

The rule allows records to be maintained electronically and provided in that form to the Commission, upon request.

4. Non-duplication

The recordkeeping requirements are intended to indicate whether third party conformity assessment body is complying with the accreditation and audit requirements of section 14 of the CPSA and the requirements of the rule. Consequently, it is unlikely that the required information is duplicated or already available from other sources. Given the statutory requirements for testing and certification, the nature of the information being collected, and the CPSC’s experience with certification programs for consumer products, no consultation regarding recordkeeping outside the agency was necessary.

5. Burden on Small Businesses

The recordkeeping requirements in the rule would likely not have a significant impact on third party conformity assessment bodies that are small businesses because the rule does not prescribe any particular method for establishing and maintaining records. Thus, third party conformity assessment bodies have the flexibility to establish and maintain the records in the manner that suits their needs. Most of the records required by the rule are already maintained by third party conformity assessment bodies as a normal business practice

6. Less Frequent Collection

Failure to provide the information would impair the CPSC’s ability to determine whether a third party conformity assessment body is complying with the accreditation and audit requirements of section 14 of the CPSA and the requirements of the rule. Less frequent information collection could hinder investigations regarding whether a third conformity assessment body’s accreditation is current and continues to meet CPSC requirements.

7. Paperwork Reduction Act Guidelines

The rule is consistent with the guidelines in 5 CFR §1320.5(d)(2) except (iv). The rule requires that the records be maintained for 5 years instead of the 3 years in the guidelines. The 5-year record retention requirement was selected to be consistent with the 5-year statute of limitations in 28 U.S.C. § 2462.

8. Consultation and Public Comments

Given the statutory requirements for third party conformity assessment body accreditation, other agencies’ methods for accreditation were examined for their suitability. Among the accreditation methods examined were:

• the National Institute of Standards and Technology’s (NIST’s) National Voluntary Laboratory Accreditation Program (15 CFR part 285);

• Customs and Border Protection’s (CBP’s) Accreditation of Commercial Labs (19 CFR part 151); and

• The Occupational Safety and Health Administration’s (OSHA’s) Nationally Recognized Testing Laboratories (NRTL) program (29 CFR part 1910).

CPSC published a notice in the Federal Register announcing the intention to renew this collection on Tuesday, June 10, 2025 (90 FR 24388). No comments were received.

9. Gifts or Payment

CPSC did not, and will not, provide any payment or gifts to respondents.

10. Confidentiality

The information submitted would be subject to the Freedom of Information Act and its exemptions to public disclosure.

A list of CPSC-Accepted Testing Laboratories is available on https://www.cpsc.gov/cgi-bin/labsearch/. Section 14(a)(3)(E) of the Consumer Product Safety Act, as amended, requires the Commission to ‘maintain on its Internet website an up-to-date list of entities that have been accredited to assess conformity with children’s product safety rules.’ The laboratories in this list have been accepted as accredited to test products to one or more of these children’s product safety rules, as identified in the accreditation scope for each laboratory.

A list of labs with adverse action taken by CPSC are available here: https://www.cpsc.gov/cgi-bin/labsearch/data/Labs%20with%20Adverse%20Action%20Taken%20by%20CPSC.pdf.

This information collection has three PIAs because there are separate systems.

11. Sensitive Questions

Information regarding ownership, business and governmental relationships, and third party conformity assessment body personnel is not generally considered sensitive. Such information could appear through the records and documentation required by the rule. However, the rule does not require the disclosure of such information.

12. Respondent Burden and its Labor Costs

Application Burden

The application for CPSC acceptance of accreditation is completed by submitting a Consumer Product Conformity Assessment Body Registration Form (CPSC Form 223); an accreditation certificate for ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories; and a statement of scope that clearly identifies each CPSC rule and/or test method for which CPSC acceptance is sought. 16 CFR 112.13(a). For independent third party conformity assessment bodies, the estimated time to complete the initial application materials is 75 minutes. For governmental and firewalled third party conformity assessment bodies, the estimate is longer because of their additional requirements. See 16 CFR 1112.13(b)-(c). Firewalled third party conformity assessment bodies will require an estimated 8.4 hours to develop and upload their requirements to the CPSC. Governmental third party conformity assessment bodies will require 3 hours to develop and upload their requirements to the CPSC.

Based on applications received from FY 2020 to FY 2024, we estimate receiving 40 applications from independent third party conformity assessment bodies, 3 applications from firewalled third party conformity assessment bodies, and 4 applications from governmental third party conformity assessment bodies, each year.

Therefore, we estimate the total hourly burden for new applications to be 87.2 hours

(75 minutes per independent application × 40 applications = 3,000 minutes or 50 hours) + (8.4 hours per firewalled application × 3 applications = 25.2 hours) + (3 hours per governmental application × 4 applications = 12 hours).

Updating Information Burden

To update the information on CPSC Form 223, third party conformity assessment bodies will not need to fill out an entirely new form to submit new information. They can access their existing CPSC Form 223 via the third party conformity assessment body application program on the CPSC’s website and change only those elements that need updating. From FY 2020 through the first half of 2025, there has been a large increase in additions to scope applications submitted each year. The additions to scope applications accommodate new testing related to toys, furniture, batteries and durable nursery products. We estimate it will take a third party conformity assessment body 30 minutes to update its information to add scope items. Further, we estimate that about 20 percent of the approximately 670 third party conformity assessment bodies will do this per year, for an estimated 134 addition to scope applications annually. Therefore, we estimate the total hourly burden to update information to be 67 hours (134 applications per year × 30 minutes per application = 4,020 minutes or 67 hours per year).

Third Party Disclosure Burden

During their normal course of business, third party conformity assessment bodies maintain testing records. In addition, CPSC requires that when a test conducted for purposes of section 14 of the CPSA is subcontracted, a prime contractor’s report must clearly identify which test(s) were performed by a CPSC-accepted third party conformity assessment body acting as a subcontractor, and the test from the subcontractor must be appended to the prime contractor’s report. Records maintained by a conformity assessment body during their normal course of business would not be considered in calculating Paperwork Reduction Act (PRA) burden, but we estimate that an average third party conformity assessment body engages in recordkeeping related to 12,000 tests annually pursuant to section 14 of the CPSA that may be considered PRA burden. We estimate that five percent of third party conformity assessment bodies, or 33.5 bodies (670 conformity assessment bodies × 5% = 33.5 subcontracting test bodies), will subcontract tests to other CPSC-accepted third party conformity assessment bodies. It is difficult to estimate how many tests will be subcontracted, but for current purposes, we estimate that of the third party conformity assessment bodies who subcontract, they will subcontract 25 percent of their tests. We estimate that it will take seven minutes, on average, to comply with the recordkeeping requirements related to subcontracted tests. If five percent of third party conformity assessment bodies subcontract 25 percent of tests annually, that is a total of 100,500 subcontract tests per year (33.5 subcontracting test bodies × 12,000 tests per body × 25% tests subcontracted = 100,500 subcontract tests). Therefore, at seven minutes per test, we estimate a total burden for third party disclosure to be 11,725 hours (or 703,500 minutes) per year to comply with the subcontracting recordkeeping requirement.

Discontinue Burden

If a third party conformity assessment body wishes to discontinue voluntarily its participation with the CPSC, an estimated 30 minutes is needed to create and submit the required documentation. See 16 CFR 1112.29. From FY 2020-24, 106 labs withdrew from the CPSC program. Accordingly, we estimate 20 labs will withdraw at an estimated total hourly burden of 600 minutes (or 10 hours) annually.

Audit Burden

The CPSC portion of the audit is required no less than once every 2 years. See 16 CFR 1112.35(b). Therefore, we estimated that 50 percent of third party conformity assessment bodies each year will go through an audit. This is based on FY20-24 data showing an average of 354 CPSC Audits per year. Based on the number of third party conformity assessment bodies that have already been accepted by the CPSC as of the end of May 2025 (686), and based upon our experience with the rate of new successful applications, we predict that the total number of third party conformity assessment bodies will be 700 by FY26. Half of those, 350, will be audited annually. Depending on the type of conformity assessment body (i.e., independent, firewalled, or governmental), and other factors not controlled by CPSC, audit burden would vary somewhat form body to body. We estimate that laboratories will spend approximately 15 minutes to resubmit their updated materials, including the CPSC Form 223, accredited scope listing and accreditation certificate for the CPSC Audis. Firewalled and governmental labs are also expected to submit and update attestation, as well as an employee undue influence memorandum. In addition, for firewalled labs, a revised risk assessment of impartiality and undue influence is also included. Therefore, the total amount of time spent by conformity assessment bodies will be approximately 87.5 hours (350 bodies audited × 15 min. per audit = 5,250 minutes, or 87.5 hours).

Total Estimated Annual Burden

Adding the annual estimated burden hours results in a total of approximately 11,977 hours (87.2 hours application burden + 67 hours updating burden + 11,725 hours disclosure burden + 10 hours discontinue burden + 87.5 hours audit burden = 11,976.7 total annual burden hours).

To calculate the total cost of this PRA burden we use the total compensation for all civilian workers, available from the U.S. Bureau of Labor Statistics “Employer Costs for Employee Compensation”, which is $47.20 per hour worked as of December 2024.² At $47.20 per hour, the total cost of the PRA burden is approximately $565,314 ($47.20 × 11,977 hours = $565,314.40).

13. Respondent Costs Other Than Burden Hour Costs

There are no costs to respondents beyond those presented in Section A.12. There are no other operating, maintenance, or capital costs associated with the collection.

14. Cost to the Federal Government

The estimated annual cost of the information collection to the Federal Government is approximately $151,170, which includes 9 staff months to review applications and audits and examine and evaluate program information. This is based on a GS-13, step 5 level salaried employee. The average annual salary for a mid-level salaried GS-13 employee in the Washington, DC metropolitan area (effective as of January 2025) is $136,658 (GS-13, step 5). This represents 67.8 percent of total compensation (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” December 2024, Table 2., percentage of wages and salaries for all civilian management, professional, and related employees: https://www.bls.gov/news.release/archives/ecec_03142024.pdf). Adding an additional 32.2 percent for benefits brings average annual compensation for a mid-level salaried GS-13 employee to approximately $201,560. Assuming that approximately 9 staff months will be required annually, this results in an annual cost of $151,170 ($201,560 per year × 0.75 years = $151,170).

15. Reasons for Change in Burden

Burden estimates are updated to reflect available data from FY2020-24. Increases in burden are a result of changes to agency estimates. The estimated annual time burden has increased from 9,134 to 11,977 hours.

16. Publication of Results

The results of this information collection will not be published.

17. Non-Display of OMB Expiration Date

The agency does not seek an exemption from displaying the expiration date.

18. Exceptions to “Certification for Paperwork Reduction Submissions”

We are not requesting any exceptions to the certification statement.

1 Certificates for children’s products (Children’s Product Certificates or CPCs) must be based on testing performed by a third party conformity assessment body whose accreditation to perform such testing has been accepted by the Commission 15 U.S.C. 2063(a)(2); 16 CFR part 1107.

2 https://www.bls.gov/news.release/archives/ecec_03142025.pdf

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