Respirator Certification Fees and Standard Test Procedures

Key points

  • NIOSH provides respirator certification fee schedules in 42 CFR Part 84 Appendix A and Appendix B.
  • NIOSH uses Standard Testing Procedures (STPs) to confirm respirators approved by NIOSH provide the expected level of protection.
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About

This page provides information on respirator certification fees and the STPs NIOSH uses to evaluate respirators. Each test conducted by NIOSH has a fee associated with it in addition to other certification fees needed to obtain and maintain NIOSH approval, as seen in Appendix A and B of .

Standard Testing Procedures

Applicants, Approval Holders, testing laboratories and others use NIOSH STPs to test respirators or their components. Each respirator submitted to NIOSH for approval must meet the applicable performance requirements outlined in 42 CFR Part 84 and the NIOSH Standard Application Procedure (SAP).

Applicants and Approval Holders must provide data that shows how the respirator they provided for evaluation meets or exceeds the performance requirements. NIOSH will also use STPs to confirm the performance of the respirator before offering an approval.

The STPs and the fees NIOSH assesses for conducting them are provided below and in the NIOSH SAPs. Since some STPs are used to evaluate both air-purifying and air-supplied respirators, they may appear in more than one list. The fee schedule can also be found in of 42 CFR Part 84.

Respirator certification fees

Applicants and Approval Holders are expected to pay the testing fees reflective of the evaluations completed by NIOSH.

  • Approval Holders can find annual fees below in the Schedule A - Annual (Fixed) Respirator Certification Fees table.
    • This fee schedule can also be found in of .
  • Applicants and Approval Holders can find general application-based fees below in the Schedule B - Application-Based Respirator Certification Fees table.
    • Specific fees described for each NIOSH STP are also provided below, along with information about fees for new or unspecified tests.
    • The fee schedule can also be found in of 42 CFR Part 84.

Schedule A

Annual (Fixed) Respirator Certification Fees

Fee type Legal citation Amount Due date
Maintenance of Product Performance (product audit) 42 CFR 84.20(b)(5)
    • Annual fee: $761 per each approval holder
  • Variable fee: As billed by NIOSH based on the respirators chosen to be tested each year.
  • Upon billing from NIOSH.1
  • October.
Records Maintenance 42 CFR 84.20(b)(1) $50 for all listed2 approvals on file with NIOSH on July 1st of each year.
  • Upon billing from NIOSH.1
  • October (beginning in 2015).
Quality Assurance Maintenance (site audit) 42 CFR 84.20(b)(4)
  • Annual fee: $3,000 per every manufacturing site registered with NIOSH.
  • Variable fee:3
    • 1 day domestic audit—$2,500 per site
    • 2 day domestic audit—$5,000 per site
    • 1 day international audit—$7,500 per site
    • 2 day international audit—$10,000 per site
  • Upon billing from NIOSH.1
  • October (beginning in 2015).
Maintenance of Testing and Approval Facilities 42 CFR 84.20(b)(2) $34 per every listed2 approval on file with NIOSH on July 1st of each applicable year.
  • Upon billing from NIOSH.1
  • October (beginning in 2015).
Maintenance of Test Equipment 42 CFR 84.20(b)(2) $36 per every active4 approval on file with NIOSH on July 1st of each applicable year.
  • Upon billing from NIOSH.1
  • October (beginning in 2015).

1 For the first year that annual fees are in effect, NIOSH will provide manufacturers with a pre-invoice/advanced billing/invoice preview no later than July 1, 2015. The actual invoice will be sent in September 2015.

2 ‘‘Listed’’ approvals include all active and obsolete approvals. The Certified Equipment List (CEL) reflects the current listed approvals maintained by NIOSH. See .

3 Applies to design as well as manufacturing sites.

4 Does not include obsolete approvals.

Schedule B

Application-Based Respirator Certification Fees

Fee type Legal citation Amount Due date
Application 42 CFR 84.20(b)(1) $200 per application submitted. Upon receipt of any application request.
Approval 42 CFR 84.20(b)(1) $100 per each certificate of approval issued. Upon completion of the application and granting of an approval number.
Approval Modification 42 CFR 84.20(b)(1) $50 per each certificate of approval modified. Upon completion of the application and issuing a modified approval.
Site Qualification 42 CFR 84.20(b)(3)
  • Existing approval holder, paper review: $400 per each request to inspect new production facility.
  • Non-approval holders:
    • Domestic site visit—$2,500
    • International site visit—$7,500
Upon agreement on the date of the site qualification examination.

Testing Fees

Additional test methods

This category is used for new, on-going, tests which are developed between revisions of the test fee schedule or for special, one-time tests which are required for respirators with unique features (per 42 CFR 84.63).*

For the standard test procedures for powered air-purifying respirators and closed-circuit escape respirators not listed in Appendix B, visit the page below.

*$500/day + the actual cost of non-NPPTL staff (typically medical staff and test subjects).

Chemical Warfare Agent testing fees

The Conformity Assessment Notices below provide information on Chemical Warfare Agent testing fees.

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