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The Status of Current Respirator Regulations and Standards
Respirators are devices that are used to protect wearers from various types of airborne hazards. The hazards may include gases, vapors, particulates, or combinations of any or all of these contaminants. Respirators can be specialized for use in industrial settings, fires, health care, or other applications.
In 2001, the National Institute for Occupational Safety and Health and the U.S. Department of Labor's Bureau of Labor Statistics conducted a voluntary survey of U.S. employers regarding the use of respiratory protection devices. The survey went to more than 40,000 employers and had a 75 percent response rate. Based on the survey, they estimated that more than 600,000 workplaces were either requiring or allowing for the voluntary use of respirators. Respirators are a vital piece of safety equipment, and they are governed by regulations and standards.
There is a big difference between a respirator regulation and a respirator standard. Respirator regulations are laws that are set in place by the government and must be complied with by the respective entity for which the law has jurisdiction. The government could be a federal agency, as well as a state and/or local entity. For the purposes of this discussion, we will focus on federal agencies. In the United States, the common agencies that might have jurisdiction over respiratory protection are the Occupational Safety and Health Administration (OSHA), the National Institute for Occupational Safety and Health (NIOSH), the Environmental Protection Agency (EPA), the Mine Safety and Health Administration (MSHA), and the Food and Drug Administration (FDA). These agencies have regulations that must be complied with by either a manufacturer or user of a respiratory protection device.
Standards are established by consensus and generally do not have the power of law, unless the government designates it as having this power. Consensus standards are usually recommendations on the use or manufacture of respiratory protection devices that are written by a group of participants who have an interest and expertise in the subject at hand. Some of the consensus organizations that write standards for respiratory protection are the American National Standards Institute/American Society of Safety Engineers (ANSI/ASSE), the National Fire Protection Association (NFPA), and ASTM International.
There are also international organizations that write standards and regulations, but for the purposes of this article we will limit discussion to happenings in the United States. Discussed below are some of the activities of the various organizations. Note that this is not an all-inclusive list of activities relating to respiratory protection in the United States.
NIOSH regulations dictate how a respirator is manufactured and sold. The overarching regulation is 42 CFR 84, which was first issued in 1995, although it did have a predecessor regulation and has had various updates since 1995. The most recent updates were for Chemical, Biological, Radiological and Nuclear (CBRN) respiratory protection generally intended for first responders. NIOSH has also updated their certification fee schedules. Currently, NIOSH is working with some of the standard consensus organizations listed above, as well as on their own, to develop updated standards that are intended to ultimately be incorporated into the NIOSH regulation or possibly incorporated as a non-mandatory/voluntary element of the standard.
NIOSH is working independently to develop an updated regulation for Powered Air Purifying Respirators (PAPRs). These are respirators that are often used in construction, manufacturing, and health care facilities. NIOSH is also working on its own to develop a Combination Unit Respirator (CUR) update. These are respirators that employ technology of two or more different types of respiratory protection devices.
NIOSH is working with ANSI/ASSE to develop a Respirator Fit Capability Standard, which NIOSH might consider incorporating into its regulations or possibly as a non-mandatory/voluntary standard. This would be a performance standard that would assess the fit of certified respirators based on a panel of surrogate users in a laboratory setting. The standard has been designated as Z88.15, Respirator Fit Capability.
NIOSH is also working with the NFPA to develop NFPA 1986, Standard on Respiratory Protection Equipment for Technical and Tactical Operations. Simply stated, this specifies the minimum design, performance, and testing requirements for self-contained breathing apparatus (SCBA) and supplied air respirators (SAR). They are also working with the NFPA to develop NFPA 1982, Standard on Personal Alert Safety Systems (PASS). This standard establishes requirements intended to ensure reliable performance of personal alert safety systems that enable emergency responders to signal for help if they are lost, disoriented, injured, trapped, or run out of breathing air.
Finally, NIOSH is working with the FDA to streamline certifications and evaluations where a manufacturer wants NIOSH approval under 42 CFR 84’s relevant standards, as well as requirements of the FDA, which include flame retardance, fluid resistance/penetration, biocompatibility, and filter penetration efficiency. Hopefully, NIOSH would review the requirements on FDA's behalf to simplify the process so that manufacturers can get new products to market in a more expeditious manner.
EPA, OSHA, and ANSI/ASSE Regulations and Standards
The EPA is promulgating Significant New Use Rules (SNURs) under the Toxic Substances Control Act for numerous chemicals. These will include specific labeling and use requirements for the manufacturers of these chemicals, as well as users. The requirements are intended to provide guidance to downstream users of the chemicals.
OSHA updated its respirator standard in 1998, 29 CFR 1910.134, and has had some updates since then on various elements of the standard. Fit testing, ensuring that a respirator fits on an individual user, is a critical element of a comprehensive respiratory program. These programs are mandatory when employers require their employees to wear any type of respiratory protection.
Fit testing can be a time-consuming process. OSHA is considering some methods that will speed up the process of fit testing but still ensure that users are properly fitted with a particular respirator.
ANSI/ASSE has several respirator standards that must be reaffirmed every five years. The overarching ANSI standard for respiratory protection is Practices for Respiratory Protection, Z88.2. This standard sets forth minimally accepted practices for occupational respirator use. It is very in depth and provides guidance that could be used above and beyond regulatory requirements. Z88.2 was last updated in 2015; there is also Z88.6, Respiratory Protection—Respiratory Use—Physical Qualifications for Personnel. Much of this standard deals with the medical evaluation of respirator users. Z88.6 was last updated in 2006 and is overdue for a rewrite or reaffirmation.
Respirator Fit Testing Methods, Z88.10, provides clear and consistent guidance on the necessary components to perform fit testing as part of a comprehensive respiratory protection program. Z88.10 was last updated in 2010. The three other standards that are currently in process, or soon to be in process, are Respiratory Fit Capability, Z88.15; Assigned Protection Factors, Z88.16; and Terminology, Z88.7.
In summary, respiratory protection is a vital component in protecting workers’ health. Although many employers and users don’t think about it, there are many facets of respiratory protection regulations and standards that are constantly being updated and/or reviewed.
There are many sources of information that can be accessed by users and employers to see what is going on. Below are some of the websites that one should consider when using respiratory protection or to evaluate what the latest issues are:
For these sites the best search word is "respirator":
For this site, the best search word is "SNUR":
This article originally appeared in the May 2017 issue of Occupational Health & Safety.
Jeffrey Birkner, Ph.D., CIH, is VP-Technical Services for Moldex-Metric, Inc., a leading manufacturer of hearing and respiratory protection equipment. For more information, visit www.moldex.com.