Release of National Academies Consensus Study Report on Protecting Workers and the Public From Inhalation Hazards

On February 10,2022, the National Academies of Sciences, Engineering, and Medicine published a Consensus Study Report titled, Frameworks for Protecting Workers and the Public from Inhalation Hazards. Federal partners, NIOSH, the Environmental Protection Agency (EPA) and the Department of State, as well as the CDC Foundation, commissioned this report to address the evolving respiratory protection needs of the public and workers not operating under a respiratory protection program.

When employers can identify inhalation hazards in advance–such as viruses, wildfire smoke, or mold–they can protect their workers with a respiratory protection program. The Consensus Study Report recommends a framework that can provide a unified and authoritative source of information for the effective oversight of the development, approval, and use of respiratory protection for the public and workers not protected by a respiratory protection program.

Gaps Identified

To this point, the federal government has exclusively directed its oversight of respiratory protection in the United States to occupational settings where hazards are identified and appropriate NIOSH-approved respiratory protection is provided as part of a respiratory protection program. These respiratory protection programs exist within workplaces where the Occupational Safety and Health Administration (OSHA) is the governing authority and regulations apply under the Occupational Safety and Health Act of 1970. Within these programs, workers undergo medical clearance, fit testing, and training on how to properly use their respiratory protective devices.

However, independent contractors, self-employed workers and “gig” workers are not considered either employees or employers, and therefore they are not covered by OSHA requirements. As a result, according to this framework, the respiratory protection needs of many workers are not being met. Additionally, those in low-paying positions, people with disabilities, and those with limited English proficiency, among other groups, are at increased risk of exposure to inhalation hazards and may not work in jobs covered by OSHA’s respiratory protection requirements.

Similarly, natural disasters and other public health concerns like infectious diseases have increasingly led the public to search for guidance on the use and value of respiratory protection. While OSHA has the primary oversight for respiratory protection use in the workplace and NIOSH is charged with testing and approving all respirators used within respiratory protection programs, their authorities remain limited to occupational settings. There is no formal authority for coordinating the development and distribution of guidance to state and local health agencies or the public. There are different types of products that are now being used by the public, including NIOSH-approved respirators, procedure masks, some of which are cleared by the Food and Drug Administration (FDA), respirators marketed as certified to standards in other countries such as KN95s, and cloth masks. Because all of these are being used outside of respiratory protection programs, there is no certifying body or formal oversight designed to ensure that these products are effective for their intended use. However, many essential aspects of a respiratory protection program, such as hazard assessments to guide respirator selection, medical clearance, regular fit testing, user training, etc., are not feasible on such a large scale. Therefore, the report recommends that a new paradigm be created to support the most effective use of respiratory protection for the public and workers who may not be adequately protected.

General Framework for Oversight and Guidance to Meet Respiratory Protection Needs

The committee’s approach to developing its recommendations incorporated the elements necessary to ensure effective respiratory protection for a wide range of users. Effective respiratory protection includes considerations such as appropriate respirator selection and use based on hazard identification, as well as product design and manufacturing. The report recognizes the need for an organization to coordinate these efforts and for the ongoing improvement of protection against specific inhalation hazards that are already known, as well as of emergency and national preparedness. Recommendations also include speeding up NIOSH’s respirator conformity assessment process by using recognized consensus standards and third-party laboratory testing, establishing comprehensive workplace exposure standards to trigger respiratory protection program requirements, and establishing and standardizing a process to determine the public’s need for respiratory protection. No matter the setting, it should be noted that efforts towards reducing an inhalation hazard at the source through engineering, administrative, and other controls should always be the first consideration.

The report’s recommendations are housed within seven core functions for both expanded occupational use and for personal use of respiratory protective devices by the public. A summary of the recommendations is listed below. The complete recommendations can be found in the report.

Developing and approving respiratory protective devices

Expanded occupational use recommendation: Improve the timeliness and capacity of NIOSH’s respirator conformity assessment processes by using recognized consensus standards where appropriate and incorporating third-party laboratory testing into its respirator approval program.

Public use recommendation: Establish a capability to oversee respiratory protection standards development and an approval process for devices used by the public.

Ensuring adequate coordination and authorities to protect the target community from inhalation hazards

Expanded occupational use recommendations: Establish OSHA as the coordinating entity for the development, functioning, oversight, evaluation, and continuous improvement of the proposed framework for ensuring that workers who are not currently protected by OSHA respiratory protection programs are adequately protected from inhalation hazards.

Public use recommendations: Establish a coordinating organization to oversee the framework for respiratory protection for the public within the Department of Health and Human Services (HHS).

This coordinating organization should be responsible for assigning and organizing roles and responsibilities of federal and other stakeholders through a structured process that matches their capabilities to the committee’s framework functions.

Assessing hazards and determining the needs for respiratory protection

Expanded occupational use recommendation: Establish comprehensive workplace exposure standards with indicators for hazards (such as wildfire smoke) to trigger respiratory protection program requirements, including for those workplaces in which respirators would not otherwise be required.

Public use recommendation: Establish and use a standardized process for determining the public’s need for respiratory protection.

Determining the Necessary Respiratory Protective Devices

Expanded occupational use recommendation: Recommend only NIOSH-approved respirators for workers without respiratory protection programs facing inhalation hazards when other forms of control (e.g., engineering, administrative) fail to protect them.

Public use recommendation: Use hazard and risk evaluations to determine the necessary respiratory protective devices for the public.

Ensuring availability and access pathways for respiratory protective devices

Expanded occupational use recommendation: Prepare to meet expanded worker respiratory protection needs through evaluations to understand and predict the potential scope of the increased need with expansion of worker coverage and the risk of future large-scale incidents or situations involving inhalation hazards.

Public use recommendation: The coordinating organization established by HHS should ensure the availability of and access to respiratory protection devices by working with relevant stakeholders, the HHS Office of the Assistant Secretary for Preparedness and Response, and OSHA, to guide stockpiling decisions.

Engaging, informing, and ensuring access for the target community

Expanded occupational use recommendation: Support the development of targeted and tailored guidance and training for workers. Relevant federal agencies should expand grant programs and other support mechanisms to facilitate the translation of existing technical information on respiratory protection into tailored and culturally appropriate guidance and training materials.

Public use recommendation: Develop culturally appropriate guidance and training on how to use respiratory protection devices, led by the Centers for Disease Control and Prevention (CDC).

Incorporating lifecycle learning and continuous improvement

Expanded occupational use recommendations: Launch expanded NIOSH research and surveillance programs, in consultation with OSHA and in collaboration with relevant federal agencies, to better understand and meet the needs of all workers facing inhalation hazards.

Conduct research on models for respiratory protection program requirements for routine workplace exposures, exposures to inhalation hazards during emergencies, and incidental exposures.

Public use recommendation: The HHS coordinating organization should continuously evaluate progress and enhance the framework’s operations based on ongoing monitoring and evaluation.

The report also notes the need to revise the Occupational Safety and Health Act of 1970 to clarify the definitions of employer and employee so that OSHA has the authority necessary to ensure respiratory protection for all types of workers. NIOSH intends to continue its review of the report and its recommendations. We will work with our partners to identify and implement approaches for coordinated public use and expanded occupational use of respiratory protective devices.

This blog was co-authored in partnership with the CDC Foundation.

Maryann M. D’Alessandro, PhD, is the Director of the NIOSH National Personal Protective Technology Laboratory.

Jaclyn Krah Cichowicz, MA, is a Health Communications Specialist for the NIOSH National Personal Protective Technology Laboratory.

Jessica Biser, MPH, is an Emergency Response Program Manager at the CDC Foundation.