§84.310 Post-approval testing.

(a) NIOSH will periodically test the capacity and performance of units of approved CCERs.

(b) NIOSH may test units that are new and/or units that have been deployed in the field and have remaining service life.

(c) NIOSH will conduct such testing pursuant to the methods specified in §§84.303 through 84.305, except as provided under paragraphs (c)(1) and (2) of this section:

(1) Post-approval tests may exclude human subject testing and environmental conditioning at the discretion of NIOSH.

(2) The numbers of units of an approved CCER to be tested under this section may exceed the numbers of units specified for testing in §§84.304 and 84.305.

(d) Failure of a unit to meet the capacity and performance requirements of this section may result in revocation of the approval for the CCER or in requirements for specific remedial actions to address the cause or causes of the failure.

(e) NIOSH will replace deployed units obtained for testing with new NIOSH-approved units of the same or similar design, at no cost to the employer.

(f) To maintain the approved status of a CCER, an applicant must make available for purchase by NIOSH, within 3 months of a NIOSH purchase request, the number of units requested by the Institute. Within any 12-month period, NIOSH will not request to purchase more than 100 units for post-approval testing.

[77 FR 14193, Mar. 8, 2012, as amended at 84 FR 16412, Apr. 19, 2019]