Approved Respirator Standards

Interim Final Rule on Approval Tests and Standards for Air-Purifying Particulate Respirators

Background

Air-purifying Respirator Certification Standards

NIOSH approves air-purifying respirators in accordance with the requirements of Title 42 Code of Federal Regulations, Part 84 (42 CFR 84). Current requirements were established in 1972 for powered air-purifying respirators (PAPRs), primarily for industrial use in mining and milling operations. These current requirements may cause PAPR blowers and batteries to be inconveniently large, heavy, or both, especially for use in the healthcare industry.

Over the past 20 years, PAPRs have played an increasing role in respiratory protection programs in the United States in the healthcare sector due to the 2002 Severe Acute Respiratory Syndrome (SARS), the 2009 H1N1 influenza, and the 2014 Ebola virus outbreaks. PAPRs are often being used in high-hazard procedures in the healthcare setting because they are designed to filter chemicals, blood-borne pathogens, and aerosol-transmissible diseases. There is a need for additional PAPRs suitable for the healthcare workers and first responders especially during public health emergencies when there may be a shortage of respirators. .

Summary of the Interim Final Rule

Using the input gained from public meetings, a co-sponsored Institute of Medicine (IOM) workshop on the “Use and Effectiveness of PAPRs in Healthcare”, and PAPR manufacturers, NIOSH has developed an interim final rule titled “Approval Tests and Standards for Air-Purifying Particulate Respirators”. By modifying and replacing some of the current PAPR requirements, manufacturers can take advantage of contemporary technology that could result in smaller and lighter-weight PAPRs having the same effective particulate protections, while increasing workplace utility for today’s diverse workforces, such as healthcare and public safety.

This rulemaking includes requirements for two PAPR classes. PAPRs tested to the current requirements relocated from subpart KK are designated series “HE”; those requirements are otherwise unchanged. Requirements for the current class HE are unchanged because those devices have a proven track record and widespread use. The existing HE requirements result in the approval of PAPRs that are well suited to heavy industry, settings where the particulates of concern may be dense in terms of their airborne concentration.

New alternate performance standards are added to existing regulatory requirements to allow approval of a new class, PAPR100. The PAPR100 class will have two series “PAPR100-N,” which is not for use against oil-based aerosols, or “PAPR100-P,” which is strongly resistant to oil aerosols. The new PAPR100 class designs will be able to offer design characteristics desired by many end-users as indicated at the public meetings and the Institute of Medicine Workshop. The new class PAPR100 will need to continue meeting the Instantaneous DOP penetration standard test procedure, TEB-APR-STP-0001. However, the silica dust test, RCT-APR-STP-0025, will not be conducted for the PAPR100 class. Instead a sodium chloride aerosol per CVB-APR-STP-0081 will be used to test PAPR100-N series filters, and a dioctyl phthalate aerosol per CVB-APR-STP-0080 will be used for testing PAPR100-P series filters. NIOSH will not designate either class specifically for industrial or non-industrial use. The new PAPR100 PAPRs will provide an equivalent level of protection as the current class PAPR HE respirators.

In addition to the new efficiency tests for PAPR100-N and PAPR100-P filters, the interim rule contains:

1. A low-flow warning requirement for the new PAPR100 class respirators only,
2. Two options to assess fit: isoamyl acetate (existing and unchanged) or generated aerosol (new) for both PAPR classes HE and PAPR100,
3. A total noise level requirement for both classes HE and PAPR100,
4. A breath response type, airflow resistance test for PAPR classes HE and PAPR100, and
5. A communication performance test for PAPR100.

New standard test procedures (STPs), as they relate to the Interim Final Rule, can be viewed at here. These STPs are also subject to comment during the comment period for the interim final rule.

PAPR100 class respirators are projected to be better suited to the needs of workers in the healthcare and public safety sectors. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for additional particulate respirators designed specifically for healthcare settings.