The Department of Health and Human Services (“HHS”) issued a proposed rule on respirator certification fees on March 27, 2013.  HHS proposed increasing the fees for respirator certifications issued by the National Institute for Occupational Safety and Health (“NIOSH”), and proposed creating a mechanism for routinely updating the fees in the future.  The proposed fee structure is designed to enable NIOSH to fully recover its costs in certifying, testing and inspecting respirators. The current fees have remained unchanged since 1972.

The Occupational Safety and Health Administration (“OSHA”) and the Mine Safety and Health Administration (“MSHA”) require employers to supply NIOSH-certified respirators to their employees whenever the use of respirators is required.  A NIOSH certificate of approval allows a respirator manufacturer the ability to sell its NIOSH-approved respirators to businesses or industries that require the use of respirators by their employees. 

The proposed rule is designed to establish new fees for the following:

  1. Reviewing applications submitted to NIOSH;
  2.  Issuing a certificate of approval;
  3. Modifying a certificate of approval;
  4. Maintaining a certificate of approval;
  5. Performing specific, standard laboratory tests which are requested by  applicants;
  6. Developing and/or performing novel tests which are required to evaluate respirator performance;
  7. Qualifying applicant respirator product sites and quality systems;
  8. Verifying quality system performance through site quality audits;
  9. Verifying commercially available respirator performance through product quality audits;
  10. Replacing testing equipment; and
  11. Providing and maintaining laboratories and office space 

The proposed fee structure takes into account the complexity of the class of respirator and the amount of testing required, as well as the work and resources required to perform the testing.

The proposed rule would also require fee schedules to remain in effect for at least one year and to be revised at least every five years.

According to HHS, the economic impact on the increased fees would cost companies with 50 or fewer employees $2,940 (or 2.2 percent of their revenue), compared with $9,595 (or 0.44 percent of their revenue) for those with 51 to 250 employees, and $18,740 (or 0.14 percent of their revenue) for companies with 251 to 500 employees.

HHS is accepting public comment until May 28, 2013.  To comment on this rule, please visit the Federal eRulemaking Portal at